Bonuses For GSK Pharma Sales Reps Won’t Be Tied to Sales

This story really had me scratching my head.  GSK has gone from 9,000+ reps to only 2,000+ reps in three years and from what I know was really pushing reps hard to sell. Now reps are going to get bonuses based on their relationship with HCP’s ?  This is very subjective and is has “litigation written all over it.  Ms Connelly has never been one to be based in reality and according to sources “Such a strategy requires using “robust” market research practices to collect all this qualitative feedback in a statistically significant way, says Redden. And feedback will have to distinguish between the sales rep and the product he or she is selling.  Good luck…it’s a good idea but I don’t believe GSK can pull it off.

Source: Wall Street Journal

Pharma seeks FDA clarity on risky drug safeguards

The FDA held meetings this week to discuss the use of REMS within the pharma industry. The key question is how to reduce the paperwork of drugs that have a Level III REMS so that HCP’s can be more compliant in prescribing Level III medications.  Also at issue is “who should enforce” compliance, drug companies or the FDA ?

Source: Reuters

The Sad Truth About $100,000 cancer drugs

Drug companies are fixated on proving their drugs extend survival or delay cancer progression by as little as a few months or weeks. This could gain them FDA approval and potentially billions in sales.   “We’ve created a multi-trillion dollar edifice for dispensing the medical equivalent of lottery tickets–and have only the rudiments of a system to prepare patients for the near-certainty that those tickets will not win,” he writes.  Life needs to be taken into account for these drugs. It rarely is in the race to try anything that might buy a little more time, no matter how slim the odds.  ”The fact that we may be shortening or worsening the time we have left hardly seems to register”

Source: Forbes

Glaxo is cleverly marketing a supplement as a drug, and making a mint in the process, when people could easily buy the same thing over the counter.

Glaxo is marketing Lovaza hard, though. This was the drug one of the Avandia panelists was being paid to give speeches to promote. I do wish GSK were doing more clinical trials to prove Lovaza does more than just lower triglycerides.  ”My main point was that Glaxo is cleverly marketing a supplement as a drug, and making a mint in the process, when people could easily buy the same thing over the counter.    And by saying that Glaxo is being clever I also meant to imply they are being deceptive.  It’s a nice trick: they have almost no downside, since fish oil is almost certain not to cause the bad side effects we saw with Vioxx (for example).”

Source: Forbes

How One Pharma Company Successfully Manages YouTube

Gary Monk, Product Manager (Marketing) at Janssen-Cilag. Gary is responsible for (among other things) administering the company’s LivingwithADHD YouTube Channel. So, along with commentary, Gary shares his perspective based on his experience with Janssen-Cilag’s relatively popular video, “ADHD: A day in the life.”

Source: Dose of Digital

Novo’s Victoza drains new scripts from rivals

The Novo Nordisk (NYSE: NVO) drug has been racking up market-share gains in the U.S., nabbing 26 percent of the market in GLP-1 drugs since its February launch. Some 33.9 percent of new GLP scrips are going to Victoza.  And that means that Eli Lilly’s (NYSE: LLY) rival GLP product, Byetta, is slipping a bit, analysts say. ”Byetta has lost shares of new prescriptions at a faster pace than in the number of total prescriptions which indicates that more doctors are giving new patients Victoza instead of Byetta,” Citigroup analyst Yaron Werber tells Borsen.

Source: Fierce Pharma

Hospitals engaging patients in social media

Is your hospital still waiting to try social media? Here’s something to consider: All 14 hospitals listed on the 2010-2011 U.S. News Honor Roll are using social media. 78% of the larger Best Hospitals List are also engaged on Facebook, Twitter and other social media sites.

A pharma mareters guide to developing a Facebook page with low risk

500 million people are now using Facebook and with the FDA not likely to issue specific guideline on social media and with the likelihood that your brand is on a Facebook Community page via Wikipedia it’s time to think about getting an agency to develop and launch a Facebook page if you can provide value and if your audience wants to talk and share information on their health conditions.

Source: World of DTC Marketing

Read more here
Weekly pill dispensary: A summary of the week’s healthcare marketing news

Why is this happening ?

More Americans also are buying high-deductible health plans that force them to bear more of the upfront costs for health services. Some 18 million Americans bought high- deductible plans this year, compared with 13 million last year, according to the consulting firm McKinsey & Co.

One company reporting evidence of lower utilization is CVS Caremark Corp., the drugstore giant. In its earnings announcement Wednesday it said it is seeing a drop- off in new prescriptions for maintenance drugs tied to a decline in physician visits.  

,said Chief Executive Tom Ryan, in a conference call with analysts. Doctor visits have declined each month this year, including a 7.6% drop in May from May 2009.

Should DTC marketers focus on only on consumers who go to their physicians or should they also try and convince people to visit their physicians for regular check-ups and when they have health issues ?  I believe it depends on the seriousness of the health condition as perceived by the patient but an integrated effort by pharma, insurers and physicians needs to remind consumers that putting off visits to physicians could cost them a lot more than time and money, it could cost them their health.

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Being a less aggressive consumer of health care is here to stay

Pharmalot: So why was this complaint filed? And why now? The issues raised are not new.
Flynn: Here’s the background. After the US Trade Rep’s 2009 report came out, which was the first under the Obama administration, there was a series of meetings between the administration and global health groups (such as Health Gap and Doctors Without Borders) and the objective was to push the administration to follow through on what the Obama campaign discussed – which was to change Bush administration policies on trade and promote more access to medicine.

Read more from the original source

For instance, he cited a recent ruling by the US Second Circuirt Court of Appeals, which actually upheld the legality of pay-for-delay deals, but at the same time, took the unusual step of inviting entities that purchase drugs and had challenged a particular deal to ask for that case to be reviewed by the full circuit, citing the “exceptional importance” of the antitrust implications (back story). And in what Leibowitz called “another promising development” last March, he pointed to a federal district court judge in Philadelphia, who denied a defense motion to dismiss an FTC case against Cephalon, which is now in the discovery phase (background).

FTC: Read more from the original source

I met some of my Twitter pals there including Ray Kerins (@RayKerins), Steve Woodruff (@swoodruff), Mario Nacinovich (@nacinovich), and Zoe Elliott Dunn (@zelliott), among others. I didn’t tweet very much while at the conference, but you can use the hastag #prsummit to see what other people were saying during the conference.

One issue many people Tweeted about was the “off the record” rule imposed by Mike Huckman (@MikeHuckman), SVP, Director of Media Strategy at MS&L, during the panel discussion “Exploring How Increasing Demands Placed on a Shrinking Number of Sector Reporters are Affecting Coverage of Health Care Issues.”

Huckman also ordered us to shut off our mobile devices and pay attention, which was difficult to do after he imposed the rule that all comments were off the record.

“No quoting… Does anyone know how bizarre this all sounds?” said Len Starnes (@lenstarnes), a nominee for the Pharmaguy Social Media Pioneer Award (see Len’s bio).

Christiane Truelove (@ChristianeTrue) said “Still disappointed media panel here was made off the record. Some interesting things were said.” She was being polite, as always.

During the Q&A, I noted that all my Twitter buddies were all atwitter about the blackout he imposed and asked Huckman a simple question: “Why?” His answer was: XXXXXXXXXXXX (redacted).

In a followup tweet to Nacinovich, Huckman said: “Apologies … 2 those disappointed it was off the record.”

“Does ‘off the record’ exist now a days?!” asked Paulo Machado (@pjmachado). I guess it does for Huckman, who, BTW, is not a candidate for any SM Pioneer Award that I know of.

Read more from the original source
Media Blackout Imposed by Media People!

It’s important to understand that even when the FDA approves a drug it does so based on clinical trial data within a population over time.  The FDA does not require post marketing requirements on all drugs (ongoing clinical trials) but virtually all drug companies continue clinical trials once a drug is approved.   So they key question thus becomes; if new side effects are detected and statistically significant what steps should the drug industry take to inform patients and HCP’s ?”

First let’s take a step back.  The key question that is troubling a lot of people is “will a drug company report more side effects or adverse events for a drug that has hundreds of millions of dollars in sales thus putting patients ahead of sales ?” As Shakespeare said “ah, there’s the rub” .  Right now that confidence level is NOT there but in all fairness analyzing statistical drug data is not easy.

So then let’s look at it from the patients point of view.  If you were taking a prescription medication and new clinical trials showed that people taking this medication were more likely to develop say insomnia, would you want to know that ? I believe the answer to that is “yes”.  I also believe that empowered patients are a lot smarter than DTC marketers give them credit for and that a lot of them can use information via the Internet to determine if the benefits of taking the drug outweigh the risks of the health condition. Patients may also do some research on what other medications are out there that could be safer with less side effects.

So how can the drug industry become more transparent ? Well first we need to understand that they can’t become totally transparent because a lot of information they have could only be understood by a physician or other HCP.   Second, there are a boatload of lawyers out there who make a very good living from litigation agains big pharma.  I believe people have the right to sue if their is negligence such as hiding information but usually the only ones to benefit from such litigation are the law firms, patients usually get small cuts.

The answer in transparency lies in building a bridge between patients, customers and medical marketing.  This means that drug companies have to do a better job informing and communicating ongoing clinical trial data as well information on how long term use of the drug effects patients.   This could be done via an ongoing CRM program that balances patient friendly information with valuable information that patients are looking for but so far most big pharma companies have failed to do this because it requires a shift in thinking from new Rx’s to current patients (mass marketing to marketing to one).

The reality is that even though the drug industry has not really embraced transparency patients and consumers are getting information on prescription drugs via an end run on the Internet.  Pharma therefore needs to decide whether they want to be part of that conversation of whether they want to say “we’re studying the data” and thus risk losing patients to half truth information.   Transparency is no longer an option today is a must and pharma is going to have to determine just how wide that door is going to open.

Read the original here
Can the drug industry really embrace transparency ?

• A former FDA official is saying “If the industry thinks the FDA is going to come out with thoughtful and complete guidance on how to use social media in 110 different circumstances, it’s going be very disappointed.” via eMarketer

• That over 60% of consumers do not want to hear from pharma companies on social media (via Rodale DTC study)

The FDA, if it follows the safe road that Mr Pitts suggests, can regulate DTC marketing but the issue at hand is that DTC marketing is evolving and changing beyond the FDA’s ability to regulate it. It is changing in that consumers today are becoming empowered patients who are in more and more frequency turning to the Internet for health information and, more importantly, their health choices.

There are some DTC marketers who feel that TV spots are going to lead to conversion but then there are some people who believe that there were weapons of mass destruction in Iraq.  What essentially has happened is a paradigm shift in the way patients are making healthcare decisions.

Patients no longer trust pharma company websites to give them the information they want and need.  They want essentially to know “how does this medication work and what potential side effects am I going to have to deal with?”   To this day the most visited pages on product websites are often the safety information pages.

Does this mean that pharma marketers are stuck doing the same old same old in an era of new media ? The answer to that is NO.  Pharma marketers can first acknowledge that TV is great for awareness but that to get consumers to ask for or talk about an Rx they need more pull through efforts such as;

• Having more than one home page targeted via different key words on search engines with messages for each segment.

• Better, more user friendly content that does not require a dictionary to understand.

• Put side effects in perspective and do more than list the side effects from clinical trials; put in language they can understand that is relevant to them.

• Share content with other health service providers and HCP’s so they can integrate within their websites.

• Join people in community.  Believe it or not you can still create a Facebook page that allows people to talk to one another and share information around a health condition.

• Deep link everything.  Help consumers find good credible information via the Internet and direct them there.

I can understand the FDA’s position.  Even if they issued guidelines they would be out of date within a few months as the web continues to evolve.  What the FDA really needs to do is decide how they can increase trust with consumers by providing clear, consumer friendly health information that help consumers make good educated health decisions.

Read more here
Two days of meeting on social media for….

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news…

Osiris Therapeutics (NASDAQ:OSIR) announced this morning that Health Canada has completed its initial evaluation and issued a priority (180-day) review for PROCHYMAL (remestemcel-L) (mesenchymal stem cells for intravenous infusion), which is seeking approval as an adult stem cell therapy for for the treatment of graft vs. host disease (GvHD).

Complete Story »

• BusinessWeek – Roche May Lose $1 Billion on Revoked Avastin Breast Cancer Use
• New York Times – This Week’s Health Industry News

When social media began to ebb from a media pathway for individuals to connect, to one where institutions and industry began to employ social media as a means of communicating with their constituencies, the pharmaceutical industry, as a highly regulated industry, lagged behind other sectors.    

Over time, however, in spite of the FDA's struggle to ascertain how to regulate this burgeoning new media, there has been a steady ebb of participation by the pharmaceutical industry, often observed and commented on by industry watchers.  A few have started blogs, most notably J&J's JNJBTW, AstraZeneca's AZ Health Connections and GSK's More Than Medicine.  And in fact, use of Twitter has grown substantially among medical product manufacturers, displaying a variety of content and styles and attracting various levels of followings. Likewise there have been several efforts in establishing a YouTube channel, some good, some quite awkward, and traffic to those pages has often been followed here.  So have changes in the makeup of the channels.    

But the embrace of Facebook has taken place much more slowly than other new media.  And yet, as pointed out earlier this year, Facebook has become an extremely important referral source - a driver of traffic – to Web pages.  That makes a more compelling case for medical product manufacturers to have a presence on Facebook, because without it, one is necessarily going to limit traffic to one's own site.    In February, Eye on FDA urged the FDA to start a Facebook page.  

However, while occurring more slowly and approached with more caution, there are several companies that now have corporate or cause-related Facebook pages.  Here they are:

• Labs Are Vital sponsored by Abbott Laboratories – the strongest of any of the company's social media efforts this is a resource dedicated to supporting laboratory professionals – a highly important and vital constituency, with 3,073 People Who "Like This"
• AstraZeneca US Community Connections – quite active and with 10,5756 People Who "Like This" – the page is quite active with video and several entries.
• AstraZenecaCareers - also quite active with a variety of resources and links back to other AZ sites – with 1,188 People Who "Like This"
• Bayer Karriere – In German, this page is for people interested in careers at Bayer and has 977 People Who "Like This"
• Bayer Sustainability – A page that is dedicated to the company's efforts in sustainability, this page has 254 People Who "Like This"
• Johnson & Johnson Network - a very thorough and active page with links to other J&J Facebook resources, and provides ancillary support for J&J's robust YouTube channel.  Has 4,704 People Who "Like It"
• Nursing Notes by Johnson & Johnson – an outreach to a singular community sponsored by J&J, it is modeled on the company's network page with links to many nursing organization pages.  Has 2,154 People Who "Like It"
• Pfizer – this is a very impressive set of resources, including for example,  links to health resources, news and even a multi-media library, and much easier to navigate than a Website. Pfizer has 5,667 People Who "Like This"

I found a few other pages that appeared to be sponsored and had logos, but had so little activity that I am not including them in the last.  

And there are other sponsored Facebook pages, particularly around disease specific support, such as a joint site run by EMD Serono and Pfizer called MS Voices, but these were the ones that I found that are tied to corporate.  The numbers, almost all under 10,000 people who are fans, may not strike you as huge.  But in social media world, if you have 3000 people following you, and they are the right 3000 people, it is huge.  

If you know of other's, please leave links in a comment.  And as always, thanks!  

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PharmaBook – Facebook and Pharma

“Although the 2010 Report shows some improvement, the Obama administration continues using Special 301 to pressure developing countries to adopt escalating intellectual property rules that are not required by any international agreement and that will negatively impact access to medicines,” says Sean Flynn, associate director of the Program on Information Justice and Intellectual Property at the George Washington University College of Law, in a statement.

“The United States continues to breach…international human rights obligations by using its ‘Special 301′ program to threaten trade sanctions against countries that do not agree to increase intellectual property protections beyond those required by the WTO TRIPS agreement,” he continues. The obligations referred to are known as the TRIPS agreement (here is a primer).

The public advocacy groups, which include Health GAP and Foundation for AIDS Rights, say recent Special 301 reports “press developing countries such as Thailand and Ecuador, to limit compulsory licenses for needed meds; restricted India, Brazil and the Philippines from defining the scope of patentability; implemented linkage between drug registration and assertions of patent protection in Chile, the Dominican Republic, Pakistan and Columbia; and adopt US or EU-style data exclusivity rules that create drug monopolies independent of patents in dozens of countries.”

Read more from the original source
US Trade Policy Violates Rights To Meds: Complaint

The FTC is challenging a 2005 deal between Cephalon and several generic drugmakers that were paid $300 million by arguing the payments bought market exclusivity. The FTC issued a subpoena last year and sought to compel Bisaro to respond to questions in connection with an investigation into that deal, although he refused to testify. Bisaro claims the FTC improperly tried to broker a deal between Watson and Apotex to “improve” the market, rather than legitimately fulfill its antitrust mission (back story).

And now, a federal judge suggests Bisaro may be right. In an order, US District Court Judge Alan Kay writes there is a “strong possibility” the FTC crossed a line and shared confidential info. He adds that the agency may have attempted to broker a deal between Apotex and Watson, and initiated its investigation “to pressure Watson” to relinquish its ‘first filer’ rights and also harassed the company when it refused to cooperate. Watson has an exclusive right to produce a generic version of Provigil, and retains that right even if the company chooses not to market one.

“The facts before us suggest that the FTC sought to place Watson between a rock and a hard place, where the only way Watson could clear its name and escape further FTC scrutiny was to give in to the pressure the FTC was placing on Watson to enter into the business deal with Apotex,” Kay writes. “This court finds that the facts presented here are extraordinary enough to grant very limited discovery.” And so Kay ruled the FTC must respond to Bisaro’s move to gain more info, but Markus Meier, assistant director of the FTC Bureau of Competition’s Health Care Division, does not have to be deposed.

Richard Feinstein, the FTC’s competition director, tells The Financial Times the agency will comply with the order and very much wants to tell its side of the story. “We think it is important that people don’t conflate something we view as a sideshow that has been ginned up by Watson with the underlying policy questions that are far more important,” he tells the paper.

“Given that the FTC and its chairman, Jon Leibowitz, have been the primary architects and supporters of the legislation, this court ruling could deal a serious blow to the credibility of the FTC in matters of patent settlement law,” Jefferies & Co. analyst Corey Davis wrote in an investor note, Reuters writes.

Read more here
FTC Is Slammed In Pay-For-Delay Case

The ads, which brag that “Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke,” are appearing in 154 publications spanning 85 different markets. The national publications include The New York Times, USA Today and The Wall Street Journal, as well as such magazines as Parade, Newsweek, Time and BusinessWeek.

Of course, the Avandia story is not over – 12 FDA panelists voted to withdraw the drug, although the agency usually takes the advice of its panels when making such decisions. Avandia, however, is a much trickier issue, given the internal bickering at the FDA over the Glaxo pill and the need for agency officials to use this decision as a defining moment for their public health mission.

“Our number one concern right now is making sure patients and physicians have the information they need about Actos and any concerns about their health,” Takeda spokeswoman Elissa Johnsen tells us. She reminds us Takeda ran a similar ad campaign the last time Avandia was beaten up publicly – in 2007, when the FDA added warnings to both drugs and Takeda tried to differentiate Actos from Avandia. The latest ad campaign, by the way, was designed by AbelsonTaylor.

San Diego-based Arena Pharmaceuticals says that just about half of the patients taking its drug lorcaserin in a two-year trial lost at least five percent of their body weight. And that’s about twice the rate of weight loss registered in the placebo group.

“It’s important to recognize we have a huge unmet need for drugs to treat obesity,” study author Steven Smith told Bloomberg. “Doctors want new tools in the toolkit to help their patients lose weight and patients want options to choose from to be able to lose weight and improve their health.”

Shares of Arena surged 12 percent on the data, which is being published in the New England Journal of Medicine. Arena is competing with Vivus and Orexigen to gain approval on a new weight drug, angling to become the first developer in more than a decade to win a new approval in the field. The FDA has an October 22 PDUFA deadline for lorcaserin. Eisai is partnered on the drug in the U.S.

- check out the Arena release
- here’s the AP report
- here’s the story from Bloomberg

Related Articles:
Arena lands $1.3B weight drug pact with Eisai
Arena Pharma heralds late-stage obesity data
Three biotechs race for Holy Grail of drug development

Read more from the original source
Arena shares surge on new round of promising lorcaserin data

Though oncologics are the biggest overall market, with $52.37 billion in 2009 sales, they are the second-fastest growing therapeutic class. Autoimmune agent sales have been increasing at a faster overall pace for five years straight, averaging almost 18 percent annual growth. This category includes blockbuster biologics–like Remicade, Enbrel and Humira–that treat a wide variety of immunological diseases. On the opposite end of the spectrum are the classes whose market is shrinking. Erythropoietins (such as Aranesp, Epogen and Procrit) experienced strong growth until 2007. Sales of the drugs dropped 20 percent in a single year following safety warnings that the class caused heart and vascular problems at higher doses.

- see the article and chart on the fast growing drug classes
- and check out this chart on the top 15 drug classes of 2009

Related Articles:
The world’s most expensive drugs
Drug sales up 5.1% in 2009
IMS: Pharma growing faster than expected

Read more from the original source
The fastest growing therapeutic drug classes

“Our analysis suggests there is a blurring of the lines which is not in anyone’s interest,” Lewis Glinert, a Dartmouth University linguistics professor and one of the co-authors, tells us. ““There should be a lot more regulation of these websites. The FDA should be more hands-on.”

For instance, they found that about three-quarters of the sites provide as much as safety info as benefit info on home pages; safety info was visible without having to scroll down slightly more than half of the time; safty info was placed in manageable paragraphs on about four-fifths of the sites; key safety items were bulleted on roughly half of the sites, and fewer than half listed benefits in a “detached tone.” Among the sites they canvassed were those for the Lipitor cholesterol pill, the Actos diabetes drug, the Nexium heartburn med and the Plavix bloodthinner.

Consequently, Glinert and co-author Jon Schommer of the Department of Pharmaceutical Care and Health Systems at the University of Minnesota, say the FDA should “bury its assumptions that a web site functions communicatively” like TV or magazine ads, or like labeling (see statement). And Glinert notes Google recently tinkered with its search function so that National Institutes of Health info about a drug is displayed near the top of search results. In his view, their research justifies the change.

As a counterpoint, Bob Ehrlich, who heads the DTC Perspectives consulting firm, wrote a note about their findings and argued that consumers are “savvy enough” to know that branded websites are a form of advertising. “I do not agree that the bells and whistles of web sites need to be overly scrutinized or restricted. A wealth of information may be confusing but that does not mean we should mandate less for the sake of simplicity. I think it is up to the consumer to discard what is not useful. The websites are there to provide depth of information the broadcast or print ads cannot provide.”

He then suggests “Glinert should be more concerned with the thousands of non-regulated web sites that offer faulty or outright dangerous alternatives to drug treatments. The web is full of bogus drugs and information. The unregulated sites are the public health risk, not drug company sites.”

In response, Glinert says “this is a cheap rhetorical ploy – ‘just look at things that are far worse, not us.’ I know that there are things that are far worse. That’s no revelation. (Pharmaceutical companies) have enough common sense to know what clear, conspicuous and neutral means, and how the average user is going to be looking at a site.”

1. Ensure that your site works with Safari 5.0, IE 8.0, Google Chrome and Firefox 4.0.

2. Ensure that your site is compatible with all smartphone browsers.

3. Eliminate FLASH and convert any flash content into HTML 5.0. Flash is on the way out thanks in large part to Apple’s iPad.  Even Microsoft is endorsing HTML 5

4. Deep link your site.  This means taking your key content and linking it deep with other health related sites.  Consumers and patients are looking for credible health information, help them get there.

5. Use roll-over definitions for complicated health terms. When someone rolls over a work they don’t understand a pop-up box will appear with the definition.

6. Don’t use off-line content and repurpose on your website.  It shows that you don’t care whether your visitors understand the content or not.

7. Use call-outs to highlight the key information you want your visitors to take away from visiting your site.

8. Keep content simple, easy to read & easy to understand even if it means hiring someone to write new content.

9. Don’t use an opening animation. A lot of people access health sites at work and it’s not good for someone who sits in a cube to hear “welcome to depression.com”.  People do not like it when someone walks onto the home page to welcome them and tries to assist them in navigating the site.  It is intrusive.

10. Keep your home page simple, clean and lead your visitors to the information they are going to want. Have more than one homepage targeted at different segments like current patients vs. prospects.  Use cookies to determine if someone if revisiting your site.  If they are serve them up a new homepage with more reenforcement messages.

11. You pictures of real people not actors or actor portrayals.  If you have to ask why than you are in trouble.

12. Make sure you site loads in 3-4 seconds. Anymore time than that and people are going to click off your site.

13. Include the ability to Tweet or post your site/page on Facebook via social media callouts on each page. If you have a good site and content share it with others !

Finally make sure that you test and validate your site for every change you make.  This means testing that all your links work, that all your tools work and than the site loads quickly and is viewed the way you had anticipated it should be viewed.  You’d be surprised how many sites look really bad on Google’s Chrome or Safari compared to other browsers.

Read more here
Some new fundamental features that every health site should have

“Philosophers and bioethicists are very logical, and they can construct strong arguments,” Abadie tells The Chronicle of Higher Education. “But what they can’t do is to go in there and do what I did—to do an in-depth ethnographic analysis, spending weeks and months with volunteers. Knowing who they are, what their neighborhoods look like, how they go through the trials, how they think and talk about the risks they’re taking.”

Some guinea pigs participate for the money, of course, and you can imagine how much more popular this has become during the Great Recession. Others, however, such as HIV patients, enroll because they feel they have personal stake in the development of new drugs and, therefore, gain psychologically, not just financially, he says. Nonetheless, he finds that many participants are in a state of denial over the possible health risks involved. And the best way to reduce risk is to examine financial conflicts of interest among researchers and universities.

So Abadie would like to see Phase 1 volunteers be recognized legally as workers, which would offer them protection under labor laws, and favors the creation of a national registry of Phase 1-trial participants. Why? He thinks a central database would prevent people from participating in too many trials and could help researchers identify long-term adverse effects associated with certain trials. What do you think?

Note: There is a poll embedded within this post, please visit the site to participate in this post’s poll.

The ruling comes amid years of courtroom and legislative wrangling over these issues. A similar law in Maine was upheld by the courts, and Maryland and Vermont have laws that have gone unchallenged, according to the National Legislative Association on Prescription Drug Prices, or NLARx. And as of last fall, 14 states enacted some form of PBM regulation, and another 10 states have regs or requirements under certain circumstances, according to Richard Cauchi, who heads the health program at the National Conference on State Legislatures. But the ruling may well cast a pall over some legislatures and the NLARx is perturbed.

“This decision undermines important consumer protections for employees in the District of Columbia, will greatly limit transparency in prescription drug purchasing, and rolls back the ongoing efforts to lower the cost of health care by reducing waste and fraud and conflicts of interest,” says Sharon Treat, a Maine legislator who heads the NLARx, in a statement. “Sadly, the federal government has regulated PBMs in only a limited way. This decision should be a wake-up call to Congress to pass pending legislation that tackles the murky and confusing practices of PBMs in a meaningful way.”

Meanwhile, the Pharmaceutical Care Management Association, the trade group for PBMs, was joyful over the prospect that state regulators may now be given pause before proceeding further with any new regs. “This ruling from one of the most respected Federal Appeals Courts in the country allows PBMs to continue to work aggressively to reduce the costs and improve the quality of prescription drug benefits for the 200 million Americans they serve,” says PCMA ceo Mark Merritt, in a statement.

 Next Sunday the opening session of the XVIII International AIDS Conference will take place in Vienna, Austria.  The conference, which used to be an annual conference and is now biannual, will bring together clinical research scientists, social scientists, health educators and of course, people with AIDS for six days.  It is an unusual conference in that it combines so many disciplines – as well as researchers and people with AIDS and HIV.  

This October will mark the 30 year anniversary when a few young gay men in San Francisco and New York were treated for Pneumocystis Carnii pneumonia,  reported by the Centers for Disease Control in June 1981.

The following year, the Gay Men's Health Crisis (GMHC) in New York was founded and I began working as a volunteer lawyer doing deathbed wills for men my age, which was 27.  Eventually I became the Director of Legal Services at GMHC where I oversaw a range of legal services to thousands and thousands of people with AIDS.  The first 16 years of the epidemic were brutal.  In the earliest days, you began each day with a glance over your body for lesions, a feel of your lymph nodes for lumps.  And nearly every day I lost clients and I lost friends.  In my office, we had "RIP" sheets distributed so that I could keep up with the clients who had died.  

During that time, I attended several of the International AIDS Conferences staged in many cities around the globe. At each, one looked desperately for some sign of hope that the sheer carnage of human life that was taking place because of the disease might abate.   And then in Vancouver at the XIth International AIDS Conference, a new class of drugs was unveiled that would change the course of the epidemic entirely.  For the first time, medical treatment began attacking the underlying cause of AIDS – the virus, instead of treating the symptoms.

Seven conferences later, everything has changed and nothing has changed.  Mortality has abated (though not disappeared) and many people today are living who otherwise would not have been had there not been treatment breakthroughs that people could access.

In anticipation of this year's conference, there is more hope.  Good news released this past week whereby researchers discovered two antibodies that may neutralize HIV strains.  If so, this discovery could advance the development of therapeutic vaccines for other diseases as well as HIV. It is a discovery that, like the advent of protease inhibitors, could change the course of the epidemic.  

But there is also cause for concern.  In the U.S., the backbone for access to life-saving medications is through funding of the Ryan White CARE Act – federal legislation that, among other things, funds state programs called AIDS Drug Assistance Programs (ADAP).  States have been facing a shortfall in funding, meaning that they are having to create waiting lists for access to care.  This prompted the Obama Administration to announce last week the reallocation of $25 million to fund the program for states.  That will not be a long-term solution and how longer term solutions are addressed may depend on political wrangling.  

Access issues are not confined to the U.S.  In addition, the President's Emergency Plan for AIDS Relief (PEPFAR) also faces funding challenges and HIV advocates have complained that funding for the program has not matched amounts allocated in 2008.   

The clock cannot turn back to pre-1996.  We must watch news out of the conference next week for that which will support our best hopes, but at the same time, address our worst fears.  For those wanting to follow news, the International AIDS Society will be running a blog from the conference and the Kaiser Family Foundation will be providing on-going coverage.  

Read more here
The XVIII International AIDS Conference – Everything Has Changed

Now for a moment think of this: a patient in a new product diabetes trial dies of a heart attack. He was overweight, had high blood pressure along with diabetes. Is the cause of death the drug or is it the fact that he was overweight and may have had CV disease ? How should the death be reported ? These are not easy questions to answer and thus you have a key issue of how data is recorded and analyzed in clinical trials.

From my standpoint I would believe that people who have Type 2 diabetes and have issues with their blood glucose may have a greater chance of CV disease than someone who does not have Type 2 diabetes. Often people who have Type 2 diabetes have the health condition because they are overweight and eat the wrong foods. So do health care professionals really have the time to analyze the data and become statisticians ?

The perception, right now, is that GSK did not report all the data when they submitted Avandia for approval. The most pointed attack on Record comes from a review by Thomas A. Marciniak, a medical team leader in the FDA division that handles heart and kidney drugs. He goes back over the patient records, and finds additional heart attacks he says should have been counted — all of them in patients who received Avandia.

Marciniak writes that the study was “inadequately designed and conducted to provide any reassurance” on Avandia’s safety. Moreover, he finds an alternative way of looking at the data, by stopping the trial when fewer patients had dropped out of the study, that also makes the result look worse. He argues that there is a heart attack risk.

So the key question is: Was the study inadequately designed and was the data an accurate review of Avandia’s safety ? If it was, the issue is then “was this on purpose ?”

Marketing Implications

So what are the implications for marketers ?

• The media has picked up on the Avandia story but so far it is not as widely circulated as you would have believed. So far most of the buzz is confined to within the diabetes community.

The brand score for Avandia this week on Facebook and Twitter was very high. Brands are scored from 1-1000.

• Eventually someone is going to ask “why didn’t the FDA catch this before ?” and this the issue of safety for other drugs already approved may come into question.

• Health care professionals don’t have the time to take a really deep dive into Avandia but I believe that a lot of physicians will move their patients off Avandia to avoid possible “issues” later on.

• I do not believe that this will taint the “whole” drug industry as far as providing data to health care professionals but I do believe that some physicians are going to have doubts about clinical results, especially from big pharma. HCP marketers are going to have to work harder now to reassure HCP’s that clinical trial data is relevant. Simply saying “it was done within good guidelines” is not going to cut it anymore.

• Consumers/patients who become aware of this issue are going to question even more the FDA process for approving drugs and may want reassurances that drugs are safe and effective. For example. Pfizer goes out of their way to talk about all the clinical trials for Lipitor and safety. However this may not be enough because they may be seen as untrustworthy.

If the entire system is corrupt than “Houston we have a major problem”. As for Avandia, the damage is done and GSK probably should have voluntary removed the product from the market “to re-review all the data as we believe patient safety is first, not sales”. However GSK’s image during this episode has been one of denial and cloak & dagger. Too bad because what they did, or didn’t do, clouds the whole industry.

Read more from the original source
Avandia Fallout: What you should know as a marketer

“It’ll help some people who are on waiting lists at a growing number of states, but it’s far from the amount that’s needed for the rest of the fiscal year. The situation continues to get worse,” Carl Schmid, deputy executive director of The AIDS Institute, an advocacy group, tells us. “It’s welcome news,” says Ann Lefert, associate director of government relations at the National Alliance of State & Territorial AIDS Directors. “But it adds real fiscal stress (to state programs) and we are very worried about their long-term stability. We will have to continue to push for more funds.”

The problem grew as federal funding failed to keep up with demand caused by more people losing health insurance and state budgets that have come under pressure, what Schmid calls “the perfect storm.” Consequently, the $25 million is far short of the $126 million sought. As Lefeft notes, the program received just $20 million in the current fiscal year and the same amount is budgted for fiscal year 2011. “It’s unclear at this point how far the $25 million) will go, but I can imagine in November and December, states receiving this will not be able to keep up with demand.”

As of last week, nearly 2,300 people were on waiting lists for medications from a dozen state ADAP programs, and a lack of funding has a dozen state programs – including some were waiting lists are growing, such as Iowa, Kentucky, North Carolina and Utah – to reduce formularies or raise eligibility (look here). Several other states are eyeing cost-cutting measures, too.

The ADAP program has a total budget of about $1.5 billion, says Schmid, who explains the federal government provides roughly $835 million, much of the rest coming from rebates issued by drugmakers. Recently, he says, several drugmakers increased their rebates and now provide around $500 million. “The situation would have been much worse if they didn’t do that,” he says. The amount of rebates “grew by about $150 million in one year.” You can read more background here.

Pharmalot: It’s been three years since you voted in favor of withdrawing Avandia? Is this deja vu? Has anything really changed?
Levin: Well, a lot of time has gone by and what has changed is that we have a lot more evidence that this risk is real. It’s not like the alarm bells that went off in 2007 haven’t rung again. In the interim, we lost some people and some people lost their health.

Pharmalot: You’re not on the panel this time around (due to a scheduling conflict), but what do you make of the way the FDA is going about this?
Levin: There is a policy issue that rarely gets mentioned. We’re not a country that uses the cautionary principle – which is guilty until proven innocent. We’re innocent until proven guilty. The burden of proof is rather high in terms of taking something away. From my perspective, it shouldn’t be hard. But in a decision-making enviromment that puts the burden on the risk side, the amount of evidence needed to take something off the market is extremely high. If you set up a very high bar, it means there’s always the possibility for the drug to remain on the market.

Pharmalot: Your organization speaks for consumers. Aren’t there consumers who will say Avandia is helpful and they shouldn’t be robbed for a drug that keeps them well?
Levin: If you have a serious condition but no treatment or only one treatment that some people can’t tolerate, the calculus is different than when you have a condition that’s amenable with a number of treatments and another drug in the same class that appears to have at least equal efficacy and a better safety profile. Clearly, this is not a condition where we have a shortage of treatments.

On these issues, there is often a schism between some patients who believe a drug in trouble is their only hope and you’ll get a lot of tesmtony in the public session in which some say ‘Please, don’t take it off the market. I’m willing to take a risk.” Some of that could be coming from astroturfing, too, you know, someone connected to a drugmaker. In any event, I don’t know if it’s true for this drug that we’ll see a lot of people say that. With so many treamtments out there, I’m not sure how many could say there’s nothing else that could control my diabetes. From my perspective, I can not understand why in the world we would keep this drug on the market. One of the reasons we aggressively treat diabetes is to prevent cardiac events. It seems a cruel irony. What’s the point?

Pharmalot: Several of the questions the advisory committee must answer offer a third option – that options A and B don’t offer enough evidence to make a decision. What does that suggest?
Levin: A decision has to be made…I don’t think it’s a good thing. I think one could argue that it means, inherently, the drug will stay on the market, becauase that third option effectively says there’s not enough evidence to say it should be taken off the market.

Pharmalot: What’s your take on the outcome of the meeting?
Levin: They could manage the risk – change the labeling to say everything else should be tried before this one drug. that this is not a drug of first choice. Or patients have to be screened for cardiovascular risks. But why bother? I think part of the problem is that the (physician) specialty world hates to give up anything. I think there has to be a community out there besides the manufacturer that fights to keep this drug available. But it certainly looks like it’s going to be dueling studies – the strength of studies showing risk versus the strength of studies showing no risks.

While it may appear to be a little too late to have a blog post about submitting your “Health Track” proposals in time for the original deadline of July 9th, the good news is that the SXSW organizing committee has extended the deadline over the weekend, so you have at least 1 more full day (till July 11th) to submit your proposals, so if you haven’t already done so, you still have a day’s reprieve — GOOD LUCK!

DISCLOSURE: I have been invited to sit on the advisory board of the SXSWi “Health Track”.

————————————-
Here’s the original post from the SXSH blog:

SXSW Health Track – Now a Mainstream Event!

In case you haven’t heard the great news, the SXSW organizing committee will be including a “Health Track” as part of the mainstream events of the wider South by Southwest festivities conference ! If you haven’t already done so, please submit your proposals for a health-related session by JULY 9th — below is a picture of the “Health” category which you can select as an option:

Thank you to everyone who supported Social Health 2010, whether as a participant, speaker, sponsor, or even just via “social conversation” — you were a big part of the success and this wonderful outcome!

Read more here
SXSW 2011 “Health Track” Proposal Deadline Extended

That is a pretty powerful statement and you have to wonder how many health care professionals are now starting to doubt the “if the whole system is corrupt”. At the heart of this debate is:

• Did GSK manipulate/leave out data when conducting clinical trials on Avandia ?

• Did someone manage the clinical trials to highlight targeted outcomes ?

According to the article in today’s Times:

The agency’s initial review of the Record trial, in 2007, found no problems. But independent researchers who have examined the health records of thousands of patients taking Avandia have found strong hints that the drug is more dangerous than GlaxoSmithKline has claimed. So Dr. Marciniak took an unusually close look at the Record study, demanding to see records that the agency rarely examines.

I wanted to gain better insights into what this article said so I spoke to some “industry insiders” who quickly informed me that “GSK has a history of funky clinical trials”. They believe that the problem is a “systemic” problem within GSK and that you have to not only take into account what they are telling you but what they “aren’t telling you” when it comes to drug data.

Make no mistake about it. This is not about Avandia vs. Actos or other diabetes drugs on the market. This is about clinical trials data used to get approval on a new drug done with good medical and business standards. The FDA should hire independent medical and regulatory people to review the drug trial and the report on the data. If it turns out that in fact GSK manipulated data and put the drugs approval of patient safety than the fine needs to be equal to the sales from the drug during it’s time on the market. Maybe then the people who put drug approval ahead of patient safety will be a priority.

What is also sad about this piece is that it casts a giant shadow on the whole drug industry including the companies that play by the rules and get good data. It’s a shame that GSK had to throw mud on its industry and heads need to roll. It’s more of a shame that GSK has issues the same response as always.

Read more from the original source
Is the entire system corrupt to the extent that we can’t trust the data ?

That is a pretty powerful statement and you have to wonder how many health care professionals are now starting to doubt the “if the whole system is corrupt”. At the heart of this debate is:

• Did GSK manipulate/leave out data when conducting clinical trials on Avandia ?

• Did someone manage the clinical trials to highlight targeted outcomes ?

According to the article in today’s Times:

The agency’s initial review of the Record trial, in 2007, found no problems. But independent researchers who have examined the health records of thousands of patients taking Avandia have found strong hints that the drug is more dangerous than GlaxoSmithKline has claimed. So Dr. Marciniak took an unusually close look at the Record study, demanding to see records that the agency rarely examines.

I wanted to gain better insights into what this article said so I spoke to some “industry insiders” who quickly informed me that “GSK has a history of funky clinical trials”. They believe that the problem is a “systemic” problem within GSK and that you have to not only take into account what they are telling you but what they “aren’t telling you” when it comes to drug data.

Make no mistake about it. This is not about Avandia vs. Actos or other diabetes drugs on the market. This is about clinical trials data used to get approval on a new drug done with good medical and business standards. The FDA should hire independent medical and regulatory people to review the drug trial and the report on the data. If it turns out that in fact GSK manipulated data and put the drugs approval of patient safety than the fine needs to be equal to the sales from the drug during it’s time on the market. Maybe then the people who put drug approval ahead of patient safety will be a priority.

What is also sad about this piece is that it casts a giant shadow on the whole drug industry including the companies that play by the rules and get good data. It’s a shame that GSK had to throw mud on its industry and heads need to roll. It’s more of a shame that GSK has issues the same response as always.

Read more here
Is the entire system is corrupt to the extent that we can’t trust the data ?

Hello World — I’ve re-surfaced !

<crickets>Chirp, chirp…</crickets!> Know what that sound is? The sound of my blog lately!

If you’re wondering what brought about this unintentional hiatus from blogging, well… I have no really good excuses, but it’s definitely been a combination of a few things, including:

• My new role at work — leading digital strategy and social media as my company prepares to commercialize and launch (hopefully) in the upcoming year.
• Planning and running the wildly successful Social Health 2010 unconference and attending SXSW.
  
• Oh yeah… and did I mention my new baby boy ? #LittleG was the nickname/hashtag I used as I live tweeted his birth in early June.

Anyway, I know these are merely excuses for not just having enough discipline to carve out some time,  sit down, and start blogging again, so I’m now making a mid-year resolution to do just that and start getting jiggy with my blog once again. Keep watching this space… I’m gonna start clearing out the cobwebs…

Read more from the original source
I’ve been a bad bad blogger…

In a release issued this morning, Merck said it would close research operations in Montreal, Canada; Boxmeer (Nobilon facility only), Oss, and Schaijk, Netherlands; Odense, Denmark; Waltrop, Germany; Newhouse, Scotland; and Cambridge (Kendall Square), MA. Merck’s manufacturing division, meanwhile, will shrink from 91 facilities at the close of the merger to 77 facilities.

Merck said that its will retain its focus on seven key therapeutic franchise areas: Cardiovascular Disease; Diabetes and Obesity; Infectious Disease; Oncology; Neuroscience and Ophthalmology; Respiratory and Immunology; and Women’s Health and Endocrine. Merck’s women’s health research, currently centered in Oss, the Netherlands, will be relocated primarily to the U.S.

“These changes are crucial to drive future growth and realize the promise of being a global health care leader for the long term,” said Merck CEO Richard Clark in a prepared statement. “While we believe these actions are necessary to support Merck’s competitive advantage, they required difficult decisions that will impact some of our colleagues, their families and local communities. We will implement our restructuring plans with the utmost care and respect for the hard-working and talented employees of Merck.”

- here’s the Merck release

Related Articles:
Merck updates pipeline with Schering additions
Merck plans to shutter three NJ R&D facilities
Merck signals deep cuts in R&D groups
Analysts cheer results from post-merger Merck

Read more from the original source
Merck to shutter eight R&D facilities in global restructuring

Recently I (and a lot of other people who write about science) received an e-mail claiming that a paper was about to come out from a group at the NIH that confirmed the first report. I let that one go by, since I thought I’d wait for, you know, the actual paper (for one thing, that would let me be sure that there really was one). Now Science reports that yes, there is such a manuscript. But. . .

Science has learned that a paper describing the new findings, already accepted by the Proceedings of the National Academy of Sciences (PNAS), has been put on hold because it directly contradicts another as-yet-unpublished study by a third government agency, the U.S. Centers for Disease Control and Prevention (CDC). That paper, a retrovirus scientist says, has been submitted to Retrovirology and is also on hold; it fails to find a link between the xenotropic murine leukemia virus-related virus (XMRV) and CFS. The contradiction has caused “nervousness” both at PNAS and among senior officials within the Department of Health and Human Services, of which all three agencies are part, says one scientist with inside knowledge.

I’ll bet it has! It looks like the positive findings are from Harvey Alter at NIH, and the negative ones are from William Switzer at the CDC. Having two separate government labs blatantly contradict each other – simultaneously, yet – is what everyone seems to be trying to avoid. Sounds to me like each lab is going to have to try the other’s protocols before this one gets ironed out. I wouldn’t be expecting either paper to appear any time soon, if that’s the case.

Read more here
XMRV and Chronic Fatigue: You Thought You Were Confused Before

Why this might work: Drug companies are seen as money hungry and interested in profits over patients. Align your product and customers with a charity that fights the health condition. It also gives consumers a reason to ask for your product when they have a lot of choices.

Idea: Patients who get a trial pack from their doctor get an access code for product.com to unlock additional information and talk to other patients who have this health condition.

Why this might work: You’re adding value to the product by providing additional information that only your customers can access. Recruit patients who would be willing to act as brand ambassadors and talk to others about the health condition and medication. Offer discounts with others on complimentary products (i.e. low sugar drink for diabetics, or 25% discount on smartphone application to help you manage your diabetes).

Idea: We value your opinion and want to hear from you so we can share your story with others

Why this might work: The reason social media is so popular is that it is real people talking to other real people. Why not give your customers a chance to be both a thought leader and enter their stories to go up on a Facebook page ? For example with the new Cymbalta campaign show how real people thought they had a problem and what they did about it and how they feel now after talking to their doctor. If these people can see real people having problems than the health conditions does not have as much of a stigma.

Idea: A CRM program, initiated with sample kit, that keeps patients on medication through personally relevant messages and support.

Why this might work: You’re taking Crestor for cholesterol and as you continue to take the product you find that your cholesterol is under control and you might even think of skipping a dose now and then. In the mail you get a nice kit informing you how the product works but also informing you that if you don’t take it every day your cholesterol could reach unhealthy levels. In order to keep you on the product you get a card with a discount every time you renew your Rx which in turn unlocks additional discounts at the pharmacy or store where you get your Rx filled. More and more research shows that people are looking to save money, even affluent shoppers are looking to trim costs.

See a trend here? Stop thinking about what you have done in the past and pushing messages to getting consumers/patients as part of your marketing. Don’t sell the product sell the benefits of the product (how it can make you feel). Americans are stressed today and going to the doctor to ask for an Rx maybe one more “thing” they have to do but it maybe delayed because they just don’t want to deal with this now. Remind them that Rx’s can enhance their lives by allowing them to live a better quality of life. DTC marketing can be relevant again just think outside the box.

Read more here
Thinking outside the box: Innovation in DTC marketing

The stock market, however, did not appear to count itself a fan of either reason or logic. DNDN shares plunged immediately after the Medicare announcement, and though it recovered some of its value as the day progressed, the sentiment that surrounded the trading declared itself clearly: If public health insurers so much as entertain the idea of rationing cancer care; if the days of Medicare virtually rubber-stamping all FDA-approved cancer therapies, regardless of cost and relative efficacy, really are over; if our federal healthcare payors are under so much financial strain that acting judiciously is even more important than acting compassionately – well, the market seemed to say one day last week, if all this is true, Provenge just might be doomed.

Disclosure: No positions

Complete Story »

The oft-told tale of Retractable Technologies is the prime anecdote – the company’s syringe, which has been the subject of endless litigation, was developed with the help of government grants. But despite a settlement with several large device makers, including Becton Dickinson, ceo Tom Shaw says this device and other products largely remain locked out of the market.

But here’s an interesting epilogue: With the first of his patents to expire in four years and insufficient funding, he struck deals with Chinese companies, “which put up money to build assembly lines in China in return for rights to produce his syringes for the Chinese market,” the mag writes. “When his patents do run out, the Chinese companies will be the ones poised to bring his technology to the world market.”

Reforming GPOs, as the article explains, is tricky business, given the high stakes involved for hospitals, device makers and the GPOs themselves. The larger issue is the extent to which GPOs rightfully serve the healthcare system at a time of rising costs. There’s another aspect to this discussion – at a time when the US economy is struggling to right itself and innovation is seen as a necessary salve, the hold that GPOs have on purchasing may undermine this goal. How so? The jobs and economic benefits that could be generated by Retractable’s efforts will likely go to Gansu Province instead of the US. But read for yourself.

The Parkinson’s UK group, however, is no longer willing to accept this excuse and has begun an online campaign to prompt Merck officials to do a better job of communicating the details and more effectively manage the ongoing problem (see here). “Waiting until 2011 is simply not good enough,” says Parkinson’s UK chief executive on the group’s web site. “This shortage should end now.”

And Margo MacDonald, a member of the Scottish Parliament and a Parkinson’s sufferer, tells The Herald: “This news really does horrify me. This drug is supplied by NHS doctors so therefore I assume that there has to be some arrangement between the Health Department and the drug’s suppliers. “I think there might be room for some political questioning as to why this has been allowed to come about.”

Other formulations of the active ingredient are available, but the issue, for some patients, is that simply switching to another medication is a difficult adjustment due to differences in other substances – although, not the active ingredient – used to make those pills.

There has been speculation on the NeuroTalk forum that warnings about compulsive behavior, which have plagued another Parkinson’s drug, Boehringer Ingelheim’s Mirapex, appeared on the Sinemet labeling (see page 6) just as the shortage began, although this logic would suggest Merck yanked the drug to avoid the sort of lawsuits that have plagued Mirapex (see this). Sinemet sales are not disclosed in the last Merck filing with the Securities and Exchange Commission (see page 5), suggesting it is not a big seller.

UPDATE: A spokeswoman for Bristol-Myers Squibb, which distributes the same product in the US, tells us the drugmaker is not having the same supply issue and so US patients are unaffected. And a Merck spokesman sends us a statement reiterating earlier remarks, while adding that supplies of “full global needs” should begin “sometime in 2011; but some countries are expected to return to regular supply earlier than this date.”

“Men on Viagra, Cialis Show Triple Rate of Sex Diseases in Study – BusinessWeek

“Men taking drugs for sexual potency showed almost triple the rate of sexually transmitted diseases compared with those not taking the medications, a Harvard University study found.

“The results, from an analysis of the health insurance claims of men aged 40 and older, may have more to do with the nature of the men using the impotence drugs than with the medicines leading them to have riskier sex, the research report said. The study, looking at men taking Pfizer’s Inc. Viagra and Eli Lilly & Co.’s Cialis, was published today in the Annals of Internal Medicine.”

Reading just the headlines and summaries such as the one above, you might be lead to believe that ED drugs CAUSE unsafe sex, which leads to more sexually-transmitted diseases (STDs). Right? WRONG!

You have to read down to the 11th paragraph of the 16 paragraph story to learn that the study does NOT prove that taking ED drugs leads to more unsafe sex. Quite the contrary: users of these drugs actually showed a DECREASE in STDs AFTER taking the drugs compared to BEFORE taking the drugs!

That paragraph states the study results: “The risk of getting HIV in the year before taking the pills was 3.32 times higher in drug-takers and 3.19 times greater in the year after, compared with those not taking the pills.” Find the article here.

In other words, the groups of men who were prescribed ED drugs were in a high risk group BEFORE being prescribed ED drugs. In the abstract, the study authors were careful to point out “Significant changes in STD rates from the year before to the year after the first ED drug prescription was filled were not documented.” Find the abstract here.

Pharma often complains that the media are “anti-pharma” and often emphasize the negative aspects of clinical trials, advertising, etc. (see, for example, “What’s the Cause of the Drug Industry’s Bad Reputation?“). The BusinessWeek article is just one case where I have to agree, although overall I sense that the industry gets a lot more positive traction from the media than negative (see, for example, “Academics Exaggerate, Journalists Regurgitate. What About Bloggers?“).

What do YOU think?

Does the Media focus too much on bad news about the pharma industry?
	Yes, definitely
	Absolutely not
	Maybe, sometimes
	More often than not
	It’s pretty much balanced
”

Read the original here
Sex, Lies, and the Media: Did Businessweek Distort the Relation Between ED Drugs and STDs?

I know that it’s not easy to work in big pharma today. There are endless and back to back meetings and matrix organizations that spread decision making so much that it’s hard to implement and do anything without major compromises that affect the way to reach and influence patients.

Working in DTC marketing is also not easy today. Risk adverse legal and regulatory teams can deflate even the best marketing plans and a changing FDA means that what is safe today may warrant a letter tomorrow. In addition to all this consumers don’t trust marketers (especially drug company marketers) and they are taking an empowered approach to their healthcare. With all this going on, plus the endless Power Point presentations to people who don’t understand marketing it’s hard to find the time to really sit down and think about how we can reach empowered patients.

Then there is the overall job market within pharma. I’m sure that a lot of people are trying their best to be invisible so that they stay under the radar. Rumors are rampant that more layoffs are coming and nobody wants to see a meeting with their manager and HR appear on their calendar.

But what we do, impact the health of patients, is too important to let the status quo remain intact. Instead of focusing on complying with management as long-term strategy for getting more stuff and being more secure , you have a chance to describe a powerful vision for the future of DTC marketing and actually be part of the change. The changes in DTC marketing that you can implement isn’t about doing what has always been done it’s about acknowledgement that marketing is open marketing that is shared with consumers.

I keep reading about new iPhone apps that the pharm world is developing but I really wonder if they were developed for the purpose of a press release and a performance review or really providing patients with a tool that they can use to manager their health. Right now people are downloading a lot of apps for their smartphones but they are also deleting a lot them after a week or two as they struggle to keep the ones that provide the best use and fit into their lives. When I did some research earlier this year we found that, depending on the disease state, a lot of patients did not want smartphone apps that reminded them they “were different” and needed something to stay healthy.

As Seth says in his book “it’s entirely possible that once you choose to become indispensable, you will not longer be loved”. That is a scary thought because a lot of people get reviewed by what co-workers say about them and if you chose not to be loved you can bet you are going to hear it come review time.

If DTC marketing is to evolve, change and remain relevant to patients and consumers it needs passionate Linchpins. These are people who exert emotional labor because they love what they do, these are people who spend a lot of time trying to get others to understand how the marketplace has changed. It is not people who go to endless meetings to quantify and justify their budgets. The passion is not making money or changing titles it’s knowing that you made a difference in the organization and patients lives. It’s believing in your product enough to want to talk to someone one on one to tell them just how good it is. It’s being an artist which is the ability to change people with your ideas and work, too create stories that people can relate to and change the marketplace.

You can chose to go down the path towards better marketing or turn

back and do the same thing again and again.

I don’t think we have the luxury of “learning to crawl before we walk”. The drug industry, and DTC marketing as well, is at a crossroads and we have to chose the path that makes the best use of consumers time and meets the brand and business objectives.

Those that take the greatest risk will get the greatest rewards. A patient who is able to use your product and live a more normal life is one of the best rewards that I can think of. The question is what risk are you willing to take ?

Read more from the original source
The tough choice pharma marketers have to make

This week Lilly launched an online ad campaign with Web MD called “Is it depression ?” The banners are appearing throughout the Web and clicking on the banner takes you to a sponsored Web MD page on Cymbalta.

The Web MD page has clearly called out messages and multiple calls to action and it is clearly indicated that the page is “sponsored content”. Clicking on the sponsored content area brings up a pop-up box stating that it is sponsored by an advertiser and is not reviewed by Web MD’s editorial staff. While some might think this is kind of harsh it is the level of transparency that consumers want today.

The tools are effective and interactive. There are tools to print questions to ask you doctor and an interactive quiz to determine if you might need help. While past quizzes indicated that a LOT of people may have needed help the Web MD quiz is both effective and can provide you with insights into whether you need help or not.

Today physicians treat conditions a lot more than they treat patients. They just don’t have the time to really sit with patients and talk to them about their health issues and possible lifestyle changes. Maybe in the near future physicians will employ a health coordinator who can either print health resources for patients or eMail them relevant health information links so patients can get up to speed from credible health sites.

I worked on the Prozac team while at Lilly and know that a lot of people are in need of help. It’s not easy to raise your hand and say I need help but today with the economy still struggling and feeling of helplessness people may need some support. There is a major difference between needing help in the form of a prescription and just needing to get make slight changes in lifestyle to enjoy life more. Today consumers do not like to make changes to their lifestyles, it’s too easy for them to take an Rx than to find time to exercise or go for walks.

I would have like to have seen some patient stories with the Cymbalta campaign because people relate more to each others experiences. I would also have liked to have seen a Facebook page on Cymbalta with patients stories, interactive quizzes and online health resources that consumers can go to read about depression. Still the Web MD campaign is a good one and it will be interesting to see the results.

Read the original here
Is it depression campaign launches this week on the Web

There have been numerous claims that a medication caused a suicide, but few lead to sweeping changes. In Canada, however, the suicide of 18-year-old Sarah Carlin, who had taken the Paxil antidepressant, is a clear exception. Following a coroner’s inquest, Canada’s provincial and federal governments were told to ensure patients are better informed about drug risks, tighten regulations on drugmakers and establish an independent agency to regulate medications.

“If these things had been in place at the time Sara was prescribed Paxil, she would be alive today,” her father, Neil Carlin, said outside court. “We consider this a great victory…We are truly confident that if these are acted upon there will be young lives saved down the road.”

For more than a year before her death, Sara had been taking Paxil, an anti-depressant, which Health Canada warns can increase the risk of suicidal events in children and adolescents under 18. The teenager hanged herself in her parents’ basement in May 2007. The inquest made numerous recommendations, which you can see if you keep reading…

Of the various recommendations, the one that is garnering the most discussion appears to be the creation of a Drug Safety Board to investigate the side effects and issue warnings to the public, doctors and hospitals. The inquest specifically recommended the new board not receive any funding from drugmakers. Drugmakers must also report all adverse events to Health Canada within 30 days.

A Glaxo spokeswoman writes to says the drugmaker “is supportive of appropriate recommendations designed to prevent similar tragedies from occurring in the future, and will give the recommendations addressed to the broader pharmaceutical industry our full attention and consideration. Sara Carlin’s death was a tragedy and we continue to express our deepest sympathies to her family.”

1. The Ministry of Health and Long-Term Care (MOHLTC) should develop a Drug Information System. This system would promote:
• Patient safety in the prescribing and dispensing of drugs.
• Collection and compilation of data in a single repository for all drugs dispensed for all Ontarians.
• Research into drug and patient safety.

2. The Drug Information System should track and monitor all drugs dispensed in Ontario regardless of who is paying for the prescription.

3. The Drug Information System should collect, compile and release data upon request to scientists such as those studying population-based health outcomes at the Institute for Clinical Evaluative Sciences.

4. The Ministry of Health and Long-Term Care should commit to developing a province-wide suicide prevention strategy as has occurred in other provinces such as Alberta.

5. The objectives of the province-wide suicide prevention strategy should include:
• Enhanced mental health and well being for Ontarians.
• The education of the public to de-stigmatize mental health disorders, including depression and substance abuse disorders.
• Improving intervention and support for Ontarians affected by depression and substance abuse.
• Improving intervention and treatment for those at risk of suicide.
• Increased efforts to reduce access to lethal means of suicide.
• Increased research activities in Ontario on suicide, suicidal behaviour and suicide prevention.
• Improved suicide and suicidal behaviour-related surveillance systems.
• Inform and educate the media into strategies when reporting deaths due to suicide to prevent ‘copy cat’ suicides from occurring.

6. Strategies in the province-wide suicide prevention strategy should be humane, effective and evidence based, respectful of community and culture-based knowledge, inclusive of research, surveillance, evaluation and reporting and reflective of evolving knowledge and practices.

7. The ministry of Health and Long-Term Care of Ontario and Government of Ontario should commit to supporting the development of a national suicide prevention strategy for all Canadians.

RECOMMENDATIONS FOR THE ONTARIO COLLEGE OF PHYSICIANS AND SURGEONS AND THE ONTARIO COLLEGE OF FAMILY PHYSICIANS

8. The Ontario College of Physicians and Surgeons and the Ontario College of Family Physicians should develop practice guidelines and training to family physicians on administering and monitoring the use of selected serotonin reuptake inhibitors (SSRIs). Those guidelines should include, but not be limited to the following:

Prior to prescribing SSRIs the physician should:
• Give the patient a physical examination.
• Request laboratory investigations, including drug screen where appropriate.
• Inform the patient of the benefits and risks, inclusive of rare and serious side effects of SSRIs.
• Inform the patient of all reasonable alternative treatments.
• Inform the patient of the treatment plan should SSRIs be prescribed.
• Discuss with the patient alcohol and substance abuse as confounders in the illness.

B: Emphasize to physicians that best practice monitoring patients for drug-related adverse events arising from the introduction of SSRIs includes a regime in which the physician should monitor the patient with weekly visits for the first month, biweekly visits for the second month, and with a following visit in the third month. This effectively would monitor the period of time with the greatest risk for the development of serious drug-related adverse events.

C: Encourage physicians to utilize tools created to monitor both disease symptoms and adverse events of patients undergoing treatment with SSRIs. An example of such a tool is the SSRI Monitoring Form for Children and Adolescents developed in June of 2009 by the British Columbia Children’s Hospital in Vancouver, British Columbia.

D: Emphasize to physicians that while having due regard for the relevant health privacy legislation in the jurisdiction of the medical practitioner relevant to capacity and consent; patients undergoing treatment should be encouraged, repeatedly if necessary, to allow communication and engagement of family members, guardians and/or trusted friends by their treating physicians to ensure that the patient and their supports are aware of the nature of their disorder and the potential side effects of prescribed medications and can assist in the monitoring for adverse drug-related events.

RECOMMENDATIONS TO THE ONTARIO HOSPITAL ASSOCIATION

9. The Ontario Hospital Association should inform its hospital members that patients suffering with mental health disorders including depression, anxiety and substance abuse and attempted suicide may present for treatment to their hospitals and emergency department. While respecting the Personal Health Information Protection Act, 2004 every effort should be made to obtain consent from the patient to allow the release of the medical records compiled to the patient’s treating family physician.

RECOMMENDATIONS TO HEALTH CANADA

10. In order to maximize the effect of Health Canada Advisories detailed drug-related adverse events, Health Canada should consider that the Health Advisories:
• Be succinct.
• Clearly set out the warning.
• Should clearly set out the body of evidence giving rise to the warning.
• Should be specific.
• Should be profiled in a way to attract the physician’s attention.

11. Health Canada, as a regulator of companies seeking drug approval, should make their approval contingent on receiving results of all clinical trials from the drug manufacturers.

RECOMMENDATIONS TO REGULATED HEALTH PROFESSIONALS

12. All colleges legislated under the Regulated Health Professions Act, 1991 should require mandatory reporting to Health Canada by its members of serious drug-related adverse events as defined by Health Canada.

RECOMMENDATIONS TO THE PUBLIC HEALTH BRANCH OF THE MINISTRY OF HEALTH AND LONG-TERM CARE AND THE MINISTRY OF EDUCATION

13. These two ministries should develop an educational program regarding mental health and substance abuse for the adolescents and youth of Ontario’s school system. The circumstances of the death of Sara Carlin as presented at the inquest may be of assistance in the development of this program. The program should seek to inform the adolescents and youth in its schools that suffering with mental health disorders including depression and anxiety is common at their age. In addition the program should:
- Seek to de-stigmatize these illnesses.
• Provide information that these conditions are treatable.
• Emphasize the importance of abstinence from alcohol and other substances as utilizing these may contribute to mental health disorders and precipitate suicidal ideation and suicide.

RECOMMENDATIONS TO THE ONTARIO COLLEGE OF PHARMACISTS AND THE ONTARIO PHARMACISTS’ ASSOCIATION

14. When a prescription is filled the patient should receive a standardized and plain language information leaflet based on the product monograph. The information provided to the patient should include:
• What the medication is for.
• What the risks of taking the medication are.
• Under what conditions the medication should not be taken.
• Interactions with the medication.
• The proper use of the medication.
• Side effects and what to do about them.

RECOMMENDATIONS TO THE CANADIAN DRUG MANUFACTURERS’ ASSOCIATION

15. Drug companies should be required to report to Health Canada all serious adverse events associated with their drugs from all foreign jurisdictions within 30 days of the adverse event.

RECOMMENDATIONS TO THE CANADIAN FEDERAL GOVERNMENT

16. There should be an arms length body independent from Health Canada called the Drug Safety Board, which is solely dedicated to drug safety, which reports to Parliament, which is funded by the Federal Government and which receives no money from drug companies. Amongst its mandated responsibilities should be drug safety research, investigating adverse reactions and issuing warnings to the public and health care professionals and hospitals.

Hat tip to Bob Fiddaman
Read more in Inside Halton and The Toronto Globe & Mail

Pharmalot: Is industry funding for CME really sustainable?
Kopelow: Right now, about 45 percent of accredited providers take no commercial support, about 68 of providers have less than 10 percent of their income coming from commercial support. Now, take away 10 or 20 percent and it’s not nothing that you’re talking about. But yet, it’s sustainable. It simply means that people have to pay 10 or 20 percent more over time to compensate for that loss. For those organizations that are entirely dependent on outside funds for their sources are commercial support, well, then it’s much more of a challenge. From the whole CME perspective, though, less than 10 percent of providers are dependent on commercial support for 80 percent of their funding.

Perhaps one of our problems is that we don’t have the data on the use of commercial support, but we will soon, on topics that are commercially supported and not. In a year from now, we can say how the profile of commercial support is spent. I would suspect the organizations that get a lot of commercial support is where the high-yield CME…

Pharmalot: During a recent NIH committee meeting, one prominent physician used the term ‘blood curdling’ to describe the rule that would prevent industry speakers at scientific sessions (back story). That’s pretty strong language. What was your reaction?
Kopelow: Look, CME began as a what you may have in your mind’s eye as a lecture hall talk – bringing in an expert and talking on a clinical subject…The rules were issued in 1992 and revised in 2004, and again last year. But the CME enterprise has changed dramatically from days being all those lectures. When I came here in 1995, there were tapes and cds where you could listen and we added journal-based CME shortly after. The Internet had just begun. We found many prominent journals were giving a credit just for reading an article. We struggled with the publishing world over to do with what I call the integration of publishing and editorializing and CME. They hand to change and so did we. The next thing we had to add was CME for large specialty societies and academic societies for scientific presentations. All of a sudden, we found everyone wanted credits given. But it doesn’t work to have a separate rule for every format…

There’s always a clash….It wouldn’t be a big surprise to say a lot of people inside the medical specialty organizations are just now learning about the implications of some our rules and regulations…The interesting issue that has raised itself globally is that standards of commercial support – our first two standards aren’t about managing money, they are about people and the presence and relationships and influence of the pharmaceutical company – these standards of commercial support are about independence, and about those people who are moving back and forth between industry and their profession, and any conflicts of interest…

There are going to be gray areas and difficult times, but they’re so small in proportion, it’s not like one mistake changes everything under the sun. But the facts and circumstances of our rules are absolutely critical. There’s no way for any of these people – from one comment made by one person – to really understand all of the context.

Pharmalot: The AHA president Clyde Yancy was pretty emphatic about seeking an appeal. He says he was able to convince the ACCME that the AHA has procedures in place to monitor presentations. What happened? No exceptions were granted?
Kopelow: A year ago, the line about right and wrong was razor sharp, but it’s wider now…Some of these organizations are only recently preparing for their annual meetings and so may not have realized some of the revisions that we made last year. So for some of them, they are treating this as brand new, but it’s been out there for a number of months…Some accredited providers have an intensive process of peer review to ensure the validity for determining the relevance of the research and how it will be presented. There are instances where research can be presented by a commercial presence, one that is ACCME-defined. This is consistent with the policy. This isn’t new.

The ACCME wants the experts to have the opportunity to do the vetting. We have to be trust there won’t be a fraud. That’s the confusion of this business.

Recent accomplishments for Avanir (AVNR) marked the most exciting quarter in the history of the company, and it is highly likely that big news is on the near-term horizon. Avanir’s share price closed at $2.67, a gross undervaluation, in Friday’s trading session. I expect Avanir’s share price to easily double prior to October when the FDA is expected to approve its key drug, Zenvia. And the stock price should easily reach $10 per share by early 2011, the expected launch time of Zenvia. The details of my analysis will be presented later in this article, but first, I will address the key drivers that make Avanir a compelling “buy and buy more” proposition:

1. Patent protection – The Company received long-term (15 year) patent protection on Zenvia, securing its monopoly on Zenvia for years to come.
2. Extremely Positive Data – Avanir provided extremely positive safety and efficacy data at the American Academy of Neurology meeting and American Psychiatric Association meeting. They also showed tolerability with common drugs Paroxetine (a common antidepressant) and Memantine, a drug Merz +Co and Forest Labs (FRX) market for ALS patients. Commenting on the AAN meeting, Keith Katkin, CEO of Avanir, states "…the physician interest level in PBA is significant and reinforces our belief there is a large unmet medical need". As a Merriman Analyst commented, "Avanir Pharmaceuticals is advancing its lead product, Zenvia, for the unique indication of pseudobulbar affect, a hitherto little-known neurological condition that may affect millions of individuals…In our view, the Phase III STAR trial data are compelling…” Evidence of the excitement about Zenvia is apparent when looking at the stock price action after the Jeffries & Company (JEF) Health Sciences presentation by Avanir on June 8. The stock price had greater than a 25% upward move in a matter of a few days. Also notable is the trading volume in the $5.00 December calls. And furthermore, Avanir boasts institutional holders such as Blackrock, which is one of the most respected hedge funds on the street.
3. Early start on marketing/awareness efforts- Awareness of PBA is growing and the management team is diligently preparing for commercial launch. Top talent Michael McFadden was hired. Mr. McFadden previously managed markets at Amylin Pharmaceuticals (AMLN). When asked by an analyst of upcoming events prior to approval, Keith Katkin responded, "…you’ll see PBA awareness advertorials within all of the medical journals. You’ll also see them in the patient-focused journals…"Also, Avanir will attend "a dozen" different neurology and psychiatry meetings. Also, quite noteworthy is that AVNR partnered with ITV and PBS and will be airing a series on PBS stations (estimated late-June to early July) about the impact of PBA on patients’ lives. Cannacord Adams analyst comments “AAN doctor opinion on Zenvia has been positive; we think that Zenvia will see good patient and doctor acceptance…”
4. Raised Capital – Debt-freeAvanir raised over $26 million through a recent stock offering such that Christine Ocampo, CFO of Avanir, stated "we expect our current cash on hand will be adequate to fund continuing operations and the clinical development of Zenvia through the anticipated FDA approval decision date…"
5. FDA Submission – The Company provided the FDA with all data needed to assess Zenvia in PBA. Approval is extremely likely as Zeniva’s two major components are not new molecular entities and the response letter submitted was solid. After reviewing the submission, Cannacord analyst commented “…any delay would be minor and not reflect negatively on Zenvia’s approvability or sales potential.” Investors will remember Dendreon’s (DNDN) situation after receiving an approvable letter from the FDA, its engagement in subsequent studies, and ultimately approval which turned a $4 stock into one that now trades above $37.

Let’s examine a price/sales multiple. Cantor Fitzgerald estimates $675 million in peak sales for Zenvia, ramping up and seeing those peak sales in 2015. Personally, I think the estimate is a bit conservative when one factors the indefinite prescribed period and the other applications of Zenvia that should be approved following the PBA approval. But, let’s go with Cantor’s sales estimate. Although there is wide variation in price/sales ratios, the average biotech trades at 3 times peak sales. Since Avanir has rights to the drug longer than most drug companies (15 years), it could reach much higher multiples. But, even using a more conservative estimate of half that figure (1.5 times price/sales), the market cap of Avanir should be over $1 billion. That’s approximately $10 per share, indeed compelling with a potential upside of over 400%! And for more short-minded investors, there are two near-term catalysts:

1. A Barron’s article this weekend mentions that 9 pharma companies (Pfizer: PFE, Merck: MRK, Eli Lilly: LLY, Bristol Myers: BMY, Novartis: NVS, Roche: RHHBY.PK, AstraZeneca: AZN, Sanofi-Aventis: SNY, and Glaxo Smith Kline: GSK) are undervalued and could rally 30%, and
2. There should be a nice run prior to FDA acceptance, easily pushing the stock to $6. I’ve taken a sizable position and am quite ready to enjoy the ride!

Disclosure: Long AVNR, DNDN, PFE

Complete Story »

Dear Mr Meyer: I came across your website through Google and as I started to read some of your entries I have to say that I wound up agreeing with a lot of what you have said and are thinking. First a little bit about me, I am a breast cancer survivor who has been in remission for 26 months now.

I am in my mid 40′s, have some college and I am married to a wonderful man with whom we have had two loving children. My mother died of breast cancer when I was younger and when I was diagnosed I was simply devastated. When I received my diagnosis from a very cold doctor who informed me like he was reading a book the first thing I did was to go home and read everything I could about breast cancer on the Internet.

I was confused by all the information and quacks that wrote about miracle cures but in my never ending search for information I learned a lot and decided to post to groups on the Internet to help others and share what I learned. I do not trust the drug companies to tell me what I wanted to know. I am not a dummy but I don’t want to know about how your drug works what I want to know is it safe, am I going to get sick from using it and what are the chances that it will help me recover and get my life back. What I found on drug company websites was a lot of slick sales jabba using words that I didn’t understand. I don’t want to follow a drug company on Facebook or Twitter because they are not going to answer my questions plus is a customer service person really a person I want to discuss my health with ? I learned through the course of my treatment that I had to take control of my own health and question everything that my doctor wanted to do much to his displeasure. I fired two doctors and finally found a great oncologist here in South Carolina who took time to sit with me and explain all my options. You are quite correct when you say that patients don’t want to have a relationship with a drug company and that the drug industry ignores patients. Since you have a background working for drug companies please continue to beat the drum and tell them that there are a lot of people like me out here who are just saying no to the drug company sales promises. Thank you…

Read more here
A empowered patients feedback

Through the lens of behavior, the new research even breaks down extra costs by therapy class. For example, more than one-third of our annual spending on medication for high cholesterol comes from wasteful behavior.

We are optimistic about achieving these potential savings because these are behaviors we know we can change. It is far simpler to alter behavior related to prescription drugs than to influence other behaviors that add unnecessary costs to our health care system, such as overeating, using tobacco, or shunning exercise.

The new research, part of the 2009 Drug Trend Report produced by Express Scripts, identifies five behavioral profiles that contribute to wasteful spending in health care:

The Active Decliner: the patient who says she feels fine most of the time and questions whether taking her medication is really necessary.

The Refill Procrastinator: the patient who gets distracted, runs out of time and fails to refill his prescription before the medicine runs out.

The Sporadic Forgetter: the patient who remembers to take her medications during the week, but gets off schedule on the weekends and simply forgets.

The Loyalist: the patient who uses brand-name medications because that’s what the doctor first prescribed. He is slow to ask his doctor about changing to a lower-cost generic drug.

The Traditionalist: the patient who routinely goes to the store for other items and enjoys the personal contact, but has never made a deliberate decision about whether to switch to Home Delivery (i.e., mail order) for her medications.

Programs that apply advanced behavioral science to health care are helping guide such people to smarter, more responsible choices in painless, voluntary and often imperceptible ways.

For example, people often put off making a decision and initiating action even when they know that the action would bring benefits. However, if we use “choice architecture” to require that patients simply choose between two options, they are far more likely to make the smarter choice.

One program presents the A-or-B option when the patient presents a prescription for a maintenance medicine. When we ask the patient to choose between filling it through mail order or filling it at a local retail pharmacy, about half of the patients currently getting their medications in retail choose the more cost-effective mail delivery option. Without requiring a choice, most stay at retail despite the higher cost, lower dispensing accuracy and lower therapy adherence associated with that option.

We’ve also found that the words we use in communications have surprisingly large effects, and that these reflect well understood principles. For example, “loss aversion” tells us that people work harder to avoid losses than to pursue gains. Thus, messages that urge patients to “stop wasting money” tend to be more effective than those that encourage them to “start saving money.”

The common thread in these approaches is that they preserve individual choice as they trigger significant improvements in behavior. For the first time, we have solutions that are fully voluntary at the patient level, yet drive decisions that are more cost-effective.

Americans spend twice as much as residents of other developed countries on healthcare, but get lower quality, less efficiency and have the least equitable system, according to a report released on Wednesday. In these times, $163 billion is far too much to waste on health care. It is in our national interest, as well as the interests of employers and other plan sponsors, to take advantage of proven steps to eliminate this burden. And we’ll feel better for it. Amen

Read more from the original source
Annual cost of non-compliance ? $163 billion

In my presentation, developing a great online health site, I detail the process of developing a great health website for consumers. However to “get there” management has to be committed to the Internet and understand the importance the Internet has on driving Rx behavior. That’s why I always recommend companies like CRM Metrix to integrate a pop-up survey for your website with test and control groups so you can collect data on intent to ask physician for Rx based on your online brand experience.

There are no shortcuts and the most difficult part of a good web strategy is to ensure that you carefully balance consumers needs and wants with brand objectives. Believe it or not it can be done if you’re willing to listen to what your audience has to say about health information.

When it comes to development there are some things that you should also do for everything you do on the Web now:

1. Test and validate your website for Internet Explorer 8.0, 7.0, Safari, Chrome, Firefox, and all mobile web browsers. You would be surprised how many drug and medical device websites are not optimized for mobile devices. No excuse for that today.

2. Get rid of any FLASH and convert to HTML 5 because more consumers are accessing the Web via mobile devices and Apple devices do not support FLASH.

3. Have multiple homepages targeted at different segments.

4. Provide links to credible information on the Internet because today there is so much information that people are looking for health cutting through the clutter.

5. Get rid of opening website animations. People want information and having someone come on your homepage and talk is intrusive to a lot of people.

6. Finally, check the load times. To many website take way too long to load. If your website doesn’t load in 3 seconds with broadband you’re losing a lot of people who don’t have the patience to wait.

The strategy drives the budget when you’re slicing up the DTC budget pie and it’s time that DTC marketers increased the size of the slice for website development in support of the brand. It’s just too damn important to ignore anymore.

Read more from the original source
There’s no shortcut in devloping a great branded website

Below is the result shown on Google after a search on “Lipitor” (click on image for an enlarged view):

At the very top is the typical AdWord that Pfizer paid for. It’s puny and uninformative and does not mention what medical condition Lipitor is approved for. Just below it is the NIH ad, which has all the required and interesting information. It even includes a little colorful pill that draws your attention to the ad and marks it as special. When you click on the NIH ad you are taken to a page on the NIH site set up especially for atorvastatin, the active ingredient in Lipitor.

This new drug ad format is the latest initiative of Google Health, which last year launched “Health OneBox” that offered easy-to-read details on illnesses and conditions with a single search.

Will these NIH ads compete with drug company’s paid search drug ads? Or can the two work in concert to increase the clickthrough rate on the paid ads?

Either way, Google stands to increase revenue from pharma paid ads. The NIH ads are just another instance of pharma losing share of voice on search engines. They must counteract that with even more advertising. Hopefully, Google’s new ad format specifically designed for pharma (see here) will win FDA approval. That format can compete more effectively with the NIH ads. Not that there’s anything wrong with the NIH ads!

Read more here
Finally, A Google Drug Search Ad Format That Has All FDA Could Want… But Pharma Can’t Use It!

First let’s look at some of the obvious insights from this morning:

• DDMAC’s Jean-Ah Kang: pay attention to internet-related letters we are issuing b/c they reflect our thinking.

• Companies should not be held liable for independent comments made about the brand.

• Be careful with your ad placements. Keep them away from off-label content when possible. We have the tech to target.

• It’s the message not the medium … but you need to understand the medium before you deliver the message.

• Majority of presentation at FDA hearings last year on SM were from agencies.

Now let’s look at reality ha?

1. Anyone can plainly see the direction the FDA is going with regards to social and Internet marketing by looking at the letters they issued. Just look at the letter last year they issued on search, that tells you a lot about what you need to know.

2. Does anyone really believe that any company should be held responsible for what others say about them ?

3. Gee I think I’ll place an online ad on a supplement site that promises miracle cures.

4. Let’s do social media because it’s hot ! Who cares if consumers don’t like and trust us ?

5. Of course most were agencies that presented at FDA conference because they see a big fat checkbook with more work they can do for clueless DTC marketers. Who the hell speaks for patients ?

As for the engagement model presented this morning ? Well according to what I saw in her presentation cancer had a low engagement score. According to my 8 months of research with consumers spanning a dozen cities and over 100 people cancer is one of the top searches for health information and people are especially interested in social media because the health information is too often difficult to understand. In fact when I forwarded a link to her presentation to the SVP of Marketing within 20 minutes he called me to say “this isn’t what we found at all !”

In addition I found that a lot of people who have rare health conditions go online to share and get information on treatment but since their overall numbers are low they score low in the engagement index.

We found that:

-Patients & caregivers are often confused by the wealth of medical information and want to here about others experiences.

-That women who have been diagnosed or are in remission with breast cancer often have very strong social media connections for both support and information.

-That others experiences often help them prepare for treatment and help them determine if the cure is worth the treatment or the if they want to try something else.

Now when it comes to social media:

You’ll notice that pharma is among the top 5 least liked Facebook pages and there is good reason for that. First people don’t trust pharma and according to recent Harris Poll over 70% of consumers said more regulation was needed of drug companies. Second, a lot of people do not want to have their names associated with a medical condition social media page. Finally, and as research has continually pointed out, consumers/patients don’t see the value of drug company social media page.

Every year it seems there are 4-5 pharma DTC conferences and more of the same old insights and updated facts (by the way any data over a year old is dated and not relevant per the emarketer data from 2008 that was presented). It’s time to stop these bullshit meetings and time to start being innovators and focusing on patients. Agencies can’t do it patients want honest, genuine communication not someone from an agency.

The reality is that the online world is moving so fast that we have lost our ability to measure it and by the time pharma and the FDA acts on it consumers and patients have moved on.

If I sound overly negative I apologize but for the last year and a half I have seen the same presentations over and over with the same insights and yet people Tweet like this is news. Maybe news to them but then one can see why marketing within the drug industry is in such a funk.

Read more from the original source
Another social media & health conference, more obvious insights

Now, though, a new report quantifies the extent to which drugmakers are researching their meds in other countries and the results suggest the concerns will not go away – 80 percent of drugs approved in 2008 had trials in foreign countries, and 78 percent of all patients were enrolled at foreign sites, according to the US Human & Health Service Inspector General. And 10 drugs approved in 2008 were tested entirely abroad with no patients in the US. Meanwhile, the FDA inspected 1.9 percent of domestic clinical trial sites and just 0.7 percent of foreign sites. And while Western Europe accounted for most foreign trial subjects and sites, Central and South America had the highest average number of subjects per site.

The issue and ensuing worries are not new, of course. An HHS OIG report in September 2001 found that “sponsors have expanded research sites into many countries that appear to have limited experience in clinical trials” and the “FDA cannot assure the same level of human subject protections in foreign trials as domestic ones.” In its latest report, the HHS suggests the FDA should require standardized electronic clinical trial data, create an internal database, inspect trials in more countries and monitor trends in foreign clinical trials not conducted under Investigational New Drug applications. But critics say the findings illustrate the ongoing problems plaguing the FDA.

The report “highlights a very frightening and appalling situation,” Congresswoman Rosa DeLauro, a Connecticut Democrat, tells The New York Times. “By pursuing clinical trials in foreign countries with lower standards and where FDA lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health.” Adil Shamoo, editor of Accountability in Research, adds that “I think this report just confirms the potential problems with foreign trials. There is less liability, patient recruitment is far easier, the concept of informed consent is not well established, and it’s cheaper.”

Drugmakers and clinical research operators, however, argue that rising costs are a legitimate concern and, moreover, clinical investigators in the US appear less interested in participating in studies. As if the HHS study was anticipated, in fact, a recent survey by the Association of Clinical Research Organizations found that between 2004 and 2007, the number of clinical trial investigators who are regulated by the FDA fell 5.2 percent in the US and 6.1 percent in Western Europe, while increasing 16 percent in Eastern Europe, 12 percent in Asia and 10 percent in Latin America.

The reasons cited by US investigators: regulations make trials difficult to manage, medical liability, and conflict of interest mandates that docs disclose financial relationships with pharma. In fact, 24 percent of US investigators are less likely to participate in trials if they are required to disclose income. And US investigators are more concerned with making money – 68 percent say this is a “very important” factor in their participation (read more here).

UPDATE: At about 4:30 pm EST, the PhRMA trade group writes us to say that the same regulatory standards apply to foreign trials as those conducted in the US. “Is it ethical to conduct such studies outside of the US? In a word: Yes. Whether the clinical research occurs in the US or outside its borders, our member companies must adhere to Good Clinical Practice guidelines.

“In fact, PhRMA has conducted educational seminars and symposiums – at times, in conjunction with the FDA – in other countries to educate potential clinical trial principal investigators about Good Clinical Practices, ethics oversight by outside review boards, and the need to maintain the highest standards for data quality.

“Regardless of the location, however, companies seeking US approval must maintain the FDA’s high standards for conducting the trial. For instance, any related trials conducted outside the U.S. must comply with FDA requirements covering Good Clinical Practices, in addition to meeting the requirements mandated in these important emerging markets.” Here is the complete PhRMA statement.

“Humana develops health game for iPhone http://bit.ly/biQKlQ”

“Besides developing original games for health,” said Paul Puopolo, leader of Humana’s Games for Health, “we partner with game developers who are open to new business models to offer unique video games that can improve health and wellness.”

That’s an interesting goal for an iPhone app worthy of further investigation. So I went to the Humana Games for Health Web site and found this promo for the Humana iPhone game app called “Colorfall”:

This is a game like Tetris where you have to arrange cascading color squares. How does this game “improve health and wellness?” Well, you are prompted to get up off your behind and use the iPhone to photograph colorful objects such as a butter dish (shown below):

The app uses the dominate color to alter the color of squares, which can help you win the game.

In other words, this game improves health and wellness by encouraging you to move around. Huh? Usually, I play games when I’m stuck in the middle seat of an airplane and not able to move around. If I were at home and went into my frig looking for colorful foods, I might just pause the game and have a snack. Butter, hmmmmm…

Anyway, Colorfall looks like a game worth trying. But I will never download it because Humana has the nerve to charge $2.99! I asked Fabio: “Why would I pay $2.99 for these games from Humana – an insurance company with $bn in assets????” To which Fabio replied: “i agree. Should be free. Who will pay? Probably Pharma cos and competitors to learn/see what others are doing.”

If you are working for a pharma company and thinking of developing iPhone or iPad game apps, I doubt you would want to charge people $2.99. People hate the pharma industry enough and are sure not to pay. People probably hate insurance companies like Humana even more. So it’s a mystery to me why Humana charges people a fee.

A better business model for game apps is to offer free games that include motivational messages or links to useful information as part of the game.

Read more here
Humana’s iPhone/iPad "Games for Health": Would You Pay $2.99 to Play?

On June 18, 2010, the Internal Revenue Service released Form 8942 and related instructions for applying for the Therapeutic Discovery Credit.  At the same time, the U.S. Department of Health and Human Services released the Project Information Memorandum to be completed and submitted along with Form 8942. Both Form 8942 and the Project Information Memorandum can be downloaded by visiting the IRS website for Form 8942 or the HHS website for the Project Information Memorandum.

While generally Form 8942 and the Project Information Memorandum were drafted as expected based on the Notice 2010-45 guidance issued on May 21, 2010, there are a few important instructive details in both documents. The most significant of these details is how the HHS will evaluate the Project Information Memorandum for certification of a project’s investment.

Recall that in order for the IRS to consider projects that have the greatest potential to create high-quality, high-paying U.S. jobs and to advance U.S. competitiveness, the HHS must first determine that an applicant’s project qualifies and shows reasonable potential in specific medical areas. The HHS does this review by examining the Project Information Memorandum. The HHS review process and scoring system for the Project Information Memorandum can be found at here. In addition to other information, this website contains a decision tree for the review process as well as a reviewer response sheet for grading the responses in the memo. Applicants should be aware of these documents in completing the application.

In terms of Form 8942, the instructions provide an interesting point regarding dividing projects into separate applications. It states that “each project will be evaluated by itself without reference to other projects. Therefore, dividing a project into multiple projects may result in the projects not meeting the selection criteria under section 48D(d)(3).” This seems to imply that if projects are divided into separate projects and applications, this division may diminish the applicant’s ability to demonstrate the project’s reasonable potential in the specific medical areas or its great potential to create high-quality, high-paying jobs. Therefore, this caution note from the IRS should be considered when deciding whether or not to split a project into separate applications for its components.

A couple of other points to note concern the election for a grant in lieu of a credit. Contrary to Notice 2010-45 §8.02(4), an applicant electing a grant need not register with the Central Contractor Registration. Also, an election for a grant will be effective only if an applicant makes the same election on all its applications for that tax year. If all of the applications do not have the grant election, the election for a grant will be invalid and the applicant will be considered for the credit only. The inconsistency can be remedied by filing an amended Form 8942 for the application that did not originally elect for a grant.

The Form 8942 instructions also help clarify the question of what can be attached to the form. Recall that the Project Information Memorandum is quite restrictive on its word limits to responses as well as attachments. While there are word limitations on Form 8942 for the general description of the project as well as responses addressing a new technology and a contract production facility, the instructions also state that supporting statements and attachments can be attached to the form. Other information contained in the instructions address the requirement that contract research included in investments must be performed on behalf of the applicant, as well as the general requirement that qualified investments are those that are or will be “paid or incurred.”

While there still may be unanswered questions such as the definition of a ”high-quality, high-paying job” as well as what “other costs” may be considered qualified investments, the release of Form 8942 and the Project Information Memorandum mark the start of the application process for certification of qualified investments under the therapeutic discovery project program. Applicants have until July 21, 2010 to submit their strongest application for consideration of this significant benefit.

Read the original here
Gaining the inside track on new biotech tax credit

Today, however, the drugmaker has begun marketing yet another statin for controlling cholesterol, which it calls Livalo. This is a big market, of course, with statins ringing up some $13 billion in sales last year. But do patients really need another one? Lilly, which actually licensed the pill from Kowa Pharmaceuticals, hopes Livalo will be distinguished from the pack because it’s metabolized differently than most statins, which could reduce unwanted interactions with other drugs.

“While there are some very good medicines in this category today, based on the number of patients who are untreated and who fail to stay on therapy tells us there is a good opportunity here,” Lechleiter tells The Indianapolis Star in an advance interview.

Maybe so, but as Miller Tabak analyst Les Funtleyder tells the paper: “I think it’s going to take a lot of work to interest physicians in a new statin. It’s going to have to work much better, or be much cheaper, or have fewer side effects than anything else on the market.” Adds Hilliard Lyons analyst Steve O’Neill: “The space for cholesterol drugs is extremely crowded. That’s just a simple fact.” Lilly hopes pricing will help – at $3.30 a tablet wholesale, Livalo will be 15 percent cheaper than Crestor.

Like its rivals, Lilly faces a huge dropoff in revenue as big sellers lose patent protection, but its situation is more precarious than others. Matters are not helped by the poor performance of its new Effiant bloodthinner. So Lilly, which recently overhauled its R&D operation, can hardly be blamed for pursuing a tactic that may help weather the storm. In fact, while Lilly has never been known for cardiovascular drugs, Lechleiter says more cholesterol-fighting research may be pursued as a way out of its mess. Whatever works, as they say. It is ironic, though, that a drugmaker that regularly describes itself as an “innovation-driven company” and whose ceo harps on that theme is forced to rely on a variation of the ‘me-too’ approach to try to get by.

OSHA’s inspection found some plant employees were exposed to excess levels of methylene chloride, a potential cardinogen, and UCB did not have effective controls to reduce exposure. Moreover, UCB failed to supply workers with appropriate respirators, provide required monitoring, medical surveillance and info about methylene chloride. The result? Six willful citations and $351,000 in proposed fines.

“These sizable fines reflect the gravity of these hazards and the employer’s knowledge of and failure to correct them,” Arthur Dube, OSHA’s area director for western New York, says in a statement. “Employees exposed to methylene chloride are at increased risk of developing cancer, adverse effects on the heart, central nervous system and liver, and skin or eye irritation. Effective safeguards are vital to the health and well-being of the workers.”

The OSHA statement adds that UCB failed to determine each employee’s exposure to methylene chloride, develop and inspect hazardous energy control procedures for all equipment, and inform employees of the existence, location and availability of exposure and monitoring records. That was worth three more serious citations with $6,300 in fines. OSHA issues serious citations when death or serious physical harm is likely to result from hazards an employer knew or should have known.

We messaged UCB over the weekend and are awaiting word. We will update you accordingly. UPDATE: At 9:45 am on Mon., June 21, a UCB spokeswoman sends us this message: “We manufacture a number of pharmaceutical products at the site, which employs approximately 258 people.

“At UCB, providing a safe and healthy work environment for our employees is an integral part of the way we operate our business. Our facility was randomly chosen for an inspection by OSHA as part of their regular inspection process. We have been actively engaged in that inspection working closely with the OSHA inspector.

UCB has implemented extensive safety programs intended to meet and exceed all OSHA requirements. We believe that our operations comply with all OSHA requirements and we are proud of our health and safety record. We are reviewing OSHA’s findings to determine our next steps. We remain committed to complying with all regulations and ensuring that we continue to provide a safe and healthy work environment for all employees.”

Shares of Cambridge, Massachusetts-based Curis (CRIS) fell nearly 50 percent on news that its experimental drug in combination with Avastin and chemotherapy failed in a mid-stage trial in metastatic colorectal cancer. The drug GDC-0449, being developed by Roche (RHHBY.PK) and Genentech (DNA), did not meet its primary endpoint of extending the time from randomization to disease progression or death in study patients who received GDC-0449 in addition to the current standard of care of Avastin and chemotherapy when compared to those patients that received only the current standard of care treatment. Curis CEO Dan Passeri said Genentech and Roche’s clinical development of GDC-0449 in other cancers continues to make good progress.

Complete Story »

These findings are especially relevant to social marketing, a discipline which can be used to help achieve social change, healthy lifestyles, individual and community behavior change. When creating health messages and materials for social marketing campaigns, health literacy levels should be taken into account so that the target audience understands the messages and embraces the desired behavior change. In addition, messages and tools should be produced for physicians to help them better communicate with patients.

Studies show that nearly 9 out of 10 adults may lack the skills needed to manage their health and prevent disease (2003 National Assessment of Adult Literacy Study). The problem of limited health literacy has been found to be even greater for older adults, those with limited education, minorities, the poor, and those with limited English proficiency. In its 2004 report, Health Literacy: a Prescription to End Confusion, the Institute of Medicine (IOM) noted that adults with limited health literacy report less knowledge about their medical condition and treatment, worse health status, less understanding and use of preventive services, and a higher rate of hospitalization. Limited health literacy affects people’s ability to:

▪ Understand instructions on prescription drug bottles and nutrition labels

▪ Act on health-related news and announcements (e.g., severe weather alerts)

▪ Share personal and health information with providers

▪ Manage chronic health conditions

▪ Understand and act on concepts like preparedness and risks associated with unhealthy behaviors and environmental issues (e.g. vote on an environmental issue like smoking bans).

▪ Understand how to locate and access affordable health care for themselves and their children.

▪ Recognize bias in health information reported by the media (e.g. pharmaceutical sponsors)

In addition to health literacy empowered patients are getting confused by all the health information available via the Internet. There are over 3,400 diabetic groups on Yahoo ! and over 2,500 Facebook pages dedicated to health. During recent research on social media and health influence we found that patients are looking for more credible sources of information and usually don’t have the time required to both research and translate the health information that is currently available.

An opportunity for DTC Marketers ?

I believe there is an opportunity for DTC marketers to held connect patients to the information they want and need. DTC marketers should:

1. Conduct market research with targeted audience members to understand what they want to know about health conditions and medications.

2. Ask consumers how THEY rate the credibility of health information (what do they look for ?).

3. Make efforts to simply content on health websites with rollovers definitions for complicated medical terms and content that speaks more in a human personal tone than a medical scientific tone.

4. Act as connectors to help empowered patients cut through the clutter of health information. This includes recommendations to social media sites via links.

5. Ensure that content is updated on a regular basis to address issues/concerns of patient because of news stories or unpublished media studies.

6. Engage though leaders to write content targeted at consumers. It has been my experience that most thought leaders are happy to write content for consumer websites. However, ensure that you are transparent listing the thought leaders credentials and relationship with your company.

Help empowered consumers and patients get the information the want and need. Stop thinking mass marketing and start thinking of a being connectors to all the health information that’s out there.

Read the original here
Health literacy and the overwhelming search for health information on line

This October I will be in Amsterdam enjoying the sights and pleasures that city has to offer. But I am not planning to buy sex or to smoke pharmaceutical substances. I do plan, however, to attend and make a presentation at the Selling Sickness conference hosted by Healthy Skepticism (Netherlands), assisted by the Dutch Institute for Rational Use of Medicine and Healthy Skepticism (International). The sponsors include the Dutch Ministry of Health and the Dutch Health Care Inspectorate. You can find the program here.

I look forward to this conference because “Female sexual dysfunction will be used as a case study to explore problems with disease promotion as well as policy options.” Ray Moynihan, journalist, co-author of the book “Selling Sickness: How The World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients” and author of “Sex, Lies & Pharmaceuticals,” is a featured speaker.

In preparation for the conference, I am following closely the news about flibanserin, a new drug developed by the German pharma company Boehringer Ingelheim (BI) for “hypoactive sexual desire disorder” (HSDD) in pre-menopausal women. Today, an FDA advisory committee will meet to review this drug’s application for marketing approval. BI must answer the question FDA always asks: is the drug safe and effective. The FDA’s own review, out yesterday, says the overall response rate in clinical trials isn’t “particularly compelling,” reports the WSJ Health Blog.

Perhaps an even more interesting question is whether or not hypoactive sexual desire disorder is a real medical condition. FDA does not consider that question when approving drugs. Whatever compound comes their way for which a drug company has clinical data, FDA’s only duty is to consider if it is safe and effective for whatever “condition” it is designed to treat. A drug company is free to invent a medical condition and FDA can’t say a word about that.

Do pharma companies “invent” medical conditions in order to sell drugs? Is hypoactive sexual desire disorder an “invented” medical condition?

One case where there is “smoking gun” evidence of a medical condition being invented by a pharma company is “overactive bladder,” another condition affecting mostly women. “Pharmacia instrumental in creating new disease,” said a marketing VP in the notes to his PowerPoint presentation made at an industry conference in October, 2002 (see Overactive Bladder: “Pharmacia instrumental in creating new disease” says Former VP).

My fellow blogger, Rich Myer, reviewed all the PR that BI is doing to create awareness of hypoactive sexual desire disorder: “In the last month, Boehringer has been trying to lay the consumer groundwork with a promotional campaign about women’s low libido, including a Web site, a Twitter feed, a Discovery Channel documentary and a publicity tour by Lisa Rinna, a soap opera star and former Playboy model, who describes herself as someone who has suffered from a disorder that Boehringer refers to as a form of ‘female sexual dysfunction.’” In his post Rich quotes Dr. Adriane Fugh-Berman, an associate professor at Georgetown University’s medical school: “This is really a classic case of disease branding,” said Fugh-Berman. “The messages are aimed at medicalizing normal conditions, and also preying on the insecurity of both the clinician and the patient.”

Oh, Oh, Rich! You are not in command of the facts. You should have read BI’s “Key Facts on HSDD and Flibanserin“. One fact cited is this: “HSDD is a medical condition – not simply ‘low libido.’”

Anyway, this is sure to be a BIG topic for discussion at the Selling Sickness conference in Amsterdam. I wonder if people from BI will be there or invited to speak? Hope so.

Read the original here
Sex, Pharmaceuticals, and Selling Sickness: I’m Looking Forward to a Great Time In Amsterdam!

Everyday consumers are hearing stories about this or that drug causing cancer or leading to other health problems. Physicians are under attack for being in the drug industries pocket and having a conflict of interest when reviewing or publishing medical studies. The Internet and social media are magnifiers for consumers confusion of drugs and health conditions causing more and more people to spend more time online researching health they they want to. More and more health social sites and communities are appearing online even as some try and add more health pages to Facebook.

Trust is the eyes of the beholder. Trust can be influenced by external circumstances beyond the control of any business. Trust is a victim of consumers who want their pound of flesh rather than talk about fixing problems so the people who try and live a decent life don’t get screwed by greedy companies.

It’s going to be extremely difficult for the drug industry to convey to consumers that patients come first ahead of profits. Sure there are new cancer drugs on the way but the perception is that we are going to have to mortgage our homes to pay for them if, God forbid, we need them.

DTC marketers need to take into account their relationship, or lack thereof, with consumers. Stop the madness of ignoring the trust issue with the public and put a strategic plan in place to start down the road to reestablishing trust full well knowing that you may have to start from scratch every once in a while.

Read the original here
Why the oil spill in the Gulf is bad news for drug marketers

At the top of the toughest critics list you’ll find the oncologic drugs committee, which recommended only 12 of 22 apps, slightly more than half. Then there’s the peripheral and central nervous system drug advisory committee, which is seven for seven in favor. The anti-viral panel registered an 80 percent thumbs up score with the lightly used gastrointestinal and reproductive health panels each scoring 60 percent positive. The endocrinologic and metabolic drugs panel–seven yeas and one nay over four years–now faces a relatively grueling schedule for a slate of new obesity drugs up for an approval.

One of the authors, Ramsey Baghdadi, told the blog that the panels appear to make their decisions on a simple, case-by-case basis, with no indication that they’re more heavily influenced by either safety or efficacy.

- here’s the story from the Wall Street Journal

Related Articles:
Analysis: Fewer approvals may prove R&D is getting tougher
Who’s up for a big FDA approval decision in the first half
Biotech drug approvals spiked in 2009

Read more from the original source
Analysts score the FDA expert panels’ approval ratings

The series explores Hypoactive Sexual Desire Disorder, which is listed in the Diagnostic and Statistical Manual of Mental Disorders, and Discovery is careful to not mention any drug, including flibanserin, the Boehringer pill, since none is approved to treat the condition. What role, if any did Boehringer have in putting this together? A Discovery spokeswoman says the network received grants, but had full editorial control and ‘third-party experts’ reviewed the content. “We just reported facts and patient stories,” the spokeswoman informs us. “…The purpose was to raise awareness of a serious condition.”

Whether the piece crosses any lines about pre-approval promotion is up to the FDA. Again, no drug is ever mentioned, so it may well be kosher. Curious? Here are parts one, two, three and four. Nonetheless, the programming is clearly designed to heighten awareness of HSDD just in time for the FDA panel meeting along with other promotional efforts, including a Twitter feed and web site run by the Society for Women’s Health Research.

The non-profit describes itself as a ‘thought leader’ dedicated to improving women’s health through advocacy, education, and research. Its corporate advisory council includes various drugmakers, including Boehringer, and SWHR’s president is quoted in the series, although there are no interviews with critics of the idea that HSDD should be treated with medication. In a note, John Whyte, Discovery’s chief medical expert and vp for CME, tells us that the group, “like most non-profits, receives funds from numerous sources” and he has known SWHR president Phyllis Greenberger many years and has never known the organization to be accused of bias.

To be clear, we are not belittling the problem and did not accuse SWHR of bias; we simply noted the connections between Discovery, Boehringer and the non-profit, all of which were disclosed. However, given the unusual debate over treating HSDD – and this is not a new debate – we wondered why the Discovery piece did not attempt to acknowledge this angle, even for a moment or two. Whyte’s reply: “We can’t accomplish everything in an hour,” he writes. “We wanted to raise awareness so people could have a conversation, if appropriate, with their doctor.” So many patient stories, so little time.

Hat tip to Bnet

The reasons for non-compliance are varied but the three biggest reasons seem to be concerns over safety, cost and patient behavior. As patients take exert more control over their health care they are learning that even medications that have been on the market for a long time may not be safe. During a recent national news report a leading physician said in an interview “people should take the smallest dose of medication possible for the shortest period of time possible”. Not exactly a good way to ensure compliance.

The pharma industry has to be very careful about programs that reward compliance because the media probably would see this as a way to keep sales growing. However fear should not prevent them from working with insurers and HCP’s to raise the rates of compliance thus lowering overall healthcare costs. There is no quick solution to increase segmentation it’s going to take a shift in marketing thinking from mass marketing mentality to a more personalized approach.

I believe that the first step in tackling the compliance challenge is to define the seriousness of non-compliance for each drug. Non-compliance for some drugs could be life threatening while others non-compliance may not be so serious. This means that drug companies need to provide good sound hard clinical data to insurers supporting compliance vs. non-compliance and this data has to be in the terms of cost to the insurer.

Once a drug is classified as compliant essential the next step in my opinion is to lay the foundation for compliance programs. Frankly the insurer knows if patients have filled their Rx and are renewing their Rx’s and as thus they could incite patients to become compliant by offering rebates in lower premiums coupled with financial incentives to lead a more healthy life (i.e. lose weight). Insurers could also, for example, require that customers log onto their insurance portal site where they could receive messages and reminders about renewal of Rx’s.

I’m not sure that email or mobile reminders would be that effective with patients. When I was marketing diabetes products we learned that patients did not want to receive emails reminders because it reminded them that they had diabetes and they didn’t like it. However, some caregivers loved the idea of mobile reminders especially for juvenile diabetes patients. One area that worked very well was the ability to download Outlook (the most widely used email program) reminders that allowed patients to set how and when they would be notified. There was also a big difference in attitude between Type 1 and Type 2 diabetics. Newly diagnosed Type 1 diabetics were still dealing with the fact that although they were healthy they had diabetes. There is a perception in our communities that people who have diabetes are in poor health and Type 1 diabetics did not like to be reminded that they were dependent on insulin.

No one solution is going to work to increase compliance among patients. It is going to take a major shift in thinking along with a more personalized approach to medicine, which is really needed today anyway. HCP’s are quickly becoming overwhelmed with information and a transformation to the online world for medical records and paperwork. Unless there is a tool that they can use to help their patients become more compliant I doubt that they would use it although the insurance companies could surely find ways to compensate physicians for having their patients become more compliant.

As long as continued pressure is brought on our healthcare system to reduce costs eventually more attention is going to have to paid to the issue of compliance purely as a cost savings program.

Read the original here
A more personalized approach to compliance

“The policy is blood-curdling,” said Keith Yamamoto, executive vice dean of the University of California, San Francisco School of Medicine. “This is conflict-of-interest considerations run amok.”

Wow! It’s as if physicians were banished from an Eden where they enjoyed the fruits of the tree of knowledge made accessible by the pharmaceutical industry. To some, it’s a development of biblical proportions that deserves an appropriate image:

Before the drug industry advocates get their panties in a bundle over this, let’s see exactly what the AHA says about the policy (find it here):

“In compliance with ACCME requirements, employees of a commercial interest entity cannot be the presenting author of the abstract. A commercial interest is defined as any entity producing, marketing, re-selling, or distributing healthcare goods or services consumed by, or used on, patients. For our purposes, an employee is defined as someone who is directly working for the commercial interest as their primary employer and the commercial interest provides their primary source of income. A person acting as a contractor to a commercial interest, providing consultation, or other services secondary to their primary appointment at, for example, a university, would not be considered an employee.”

“If the abstract is selected for presentation (oral or poster),” says AHA, “the employee of the commercial interest cannot present but must select another author.”

What this means is that an abstract that is authored soley by a physician or physicians DIRECTLY employed full-time by a pharmaceutical company can be blocked. Otherwise, another, non-pharma employee author can make the presentation. There is almost always other non-pharma authors, including the physicians who ran the clinical studies being reported. Also, ghostwriters can make presentations, as indicated by this FAQ from AHA:

Q: I am the primary author of an abstract and designated as the presenter. I am currently employed by a home health agency. Can I still present my abstract?

A. Yes, the ACCME does not consider providers of clinical service directly to patients to be commercial interests.

IMHO, all the fuss over this AHA decision is unjustified as far as physician education is concerned. It may, however, be a blow to pharma research physicians who do all their clinical trials in-house without using independent physicians outside the firm. And that kind of “science” we can do without.

Read more from the original source
Are Docs Being Banished from Pharma’s Garden of Eden?

What followed, however, was equally interesting. Keith Yamamoto, executive vice dean of the University of California, San Francisco School of Medicine, pointed out that the American Heart Association is being prevented from allowing pharmaceutical industry employees make any presentations duing the scientific sessions of its upcoming annual meeting (for the curious, go to this link and fast forward to about 1 hour minute and 48 minutes seconds to hear this discussion).

Why? Last year, the Accreditation Council for Continuing Medical Education, which promulgates a code governing interaction with drugmakers, clarified a 2004 rule (see questions 8, 9 and 10 here) that prohibits such activity. “The policy is blood curdling,” Yamamoto said. “This is conflict-of-interest considerations run amok.”

Collins, who remarked on the “gasps heard around the room” after Yamamoto spoke, was quick to agree. “This is a breathtaking sweep to squash something that’s really important to us, which is science that is going on in the private sector…This is a seriously distressing step….taking what was an important principle and pushing it in a drection that makes no sense for the progress of science.”

Another panel member, AHA president Clyde Yancy, says the organization is appealing. “We were told we could not integrate the science (from industry employees) into any sessions. We could not invite speakers to be on our programs unless they were in a separate venue. And we could not portray the work unless it was in a separate geographic location from other CME. We’re aggressively appealing and working against it.”

The ACCME rules do not prevent pharma employees from making presentations not in a CME setting. In any event, an ACCME spokeswoman was unable to say whether a formal appeal was made by the AHA or whether exceptions may be granted. We will update you with additional info. However, as The Milwaukee Journal-Sentinel reports in a thoughtful story about this issue, in the 2008-09 fiscal year, the AHA received about $11 million from drug and device makers, including $1.7 million directly for CME. We are awaiting word on the share this represents of the AHA budget.

“This financing is recognition of the strength of our tafamidis program and will allow us to continue advancing the development of tafamidis. We anticipate filing marketing applications in the second half of 2010,” said Richard Labaudinière, Ph.D., president and CEO of FoldRx. “With the addition of two top-tier venture firms to our already strong investor base, we believe we now have access to the resources necessary to commercialize tafamidis and build FoldRx into an independent, orphan-disease focused company.”

FoldRx’s lead program is focused on the treatment of TTR amyloid polyneuropathy (ATTR-PN) and a second tafamidis program has pushed through Phase II on TTR amyloid cardiomyopathy, which leads to heart failure.

Last summer FoldRx touted the results of a II/III trial of tafamidis-calling it the “first disease-modifying agent targeting the underlying cause of a human amyloid disease.” The research has been funded by the National Institutes of Health, the Skaggs Institute for Chemical Biology, and The Lita Annenberg Hazen Foundation.

- here’s the FoldRX release for more info

Related Article:
FoldRx touts tafamidis data

Read the original here
FoldRx banks $29M for neurodegenerative drug application

Lately, though, Insel has been caught up in a bit of a conflicts quagmire himself after a report that, at the same time he was sorting out the proposal, he was allegedly helping one academic – Charles Nemeroff, who has been the target of a US Senate Finance Committee probe – land a new job at another university. The disclosure prompted the committee to widen its ongoing probe into Nemeroff and his new employer, the University of Miami (see this), and put Insel on the defensive, especially since he was described as having a long-running relationship with Nemeroff (look here).

In his own blog post last week, Insel denied that he had not taken the need for conflicts-of-interest rules seriously or that he encouraged Nemeroff to apply for new NIH grants at Miami; existing NIH rules allow academics to do so after switching jobs, he explained, if they haven’t been disbarred. However, NIH director Frances Collins may consider a rule change to prevent such situations from occuring. Meanwhile, newly disclosed emails indicate that last year – just as the NIH was reviewing COI rules – Insel wasn’t in favor of creating an office to handle the problem (see here). And so the Project on Government Oversight, a non-profit, has written a letter Collins to ask that Insel be removed from the COI rules project due to his ” mushy ethical standards.” What do you think?

Note: There is a poll embedded within this post, please visit the site to participate in this post’s poll.

More than some other specialties, psychiatry has been singled out as part of a US Senate Finance Committee probe into financial conflicts of interest among academic psychiatrists who accept federal funding while simultaneously maintaining relationships with drugmakers that market antidepressants and antipsychotics (background). Two recent papers raised questions about undue industry influence (see this).

“We’re trying to make clear to folks what the rules are,” James Scully, the APA medical director and ceo, tells us and notes that more specifics should be forthcoming. “We’re trying to make things clear and explicit rather than implicit. Awareness grew over the last several years and there’s a problem that needs attending to…so it’s time to look at it. A number of people, including (APA) members and residents in particular. the younger folks, were increasingly distressd at the role of the pharmceuticl industry…We need to be clear that we are educating them and are free of marketing influences, and free of conflicts of interest. Everybody should understand what a conflict is when there’s a third party involved.”

UPDATE: Separately, the APA assembly late last week rejected a separate set of 14 recommendations to regulate individual psychiatrist relationships with industry. The draft report, which was developed by an 11-member working group headed by former APA president Paul Appelbaum, had released a year ago and distributed to APA members for feedback. “As the opposition ages out of the organization and as younger psychiatrists who grew up in a different ethical environment and have different professional values that are more reflective of those of mainstream medicine, age into the organization, these guidelines will inevitably be adopted by the APA. It may not happen at the next assembly meeting in November, but I have every expectation that it will eventually happen,” Joshua Sonkiss told Medscape.

The APA code that as adopted was begun while Alan Schatzberg, who was among those probed by the committee (see here and here), was the organization’s president. He told the WSJ Health blog that the APA wants a “collaborative relationship” and that it’s “not in anyone’s best interest to shut out an industry voice.”

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Of course, there are various reasons to maintain a working relationship with industry, starting with info about useful treatments. At the same time, the APA is under financial pressure after eliminating industry-funded sessions at its annual meetings. Over the past year, the group experienced a $7.5 million drop in industry revenue, which the WSJ notes amounts to a 10 percent cut.

For those who may not recall, China executed Zheng Xiaoyu, the former head of its FDA, for approving untested medicine in exchange for cash. During his tenure, the agency approved six meds that turned out to be fake, and drugmakers had used falsified documents to apply for approvals (background). After that embarassing episode, China placed its FDA under the jurisidication of the Ministry of Health, although the move apparently has not produced the desired result.

What prompts us to make such a remark? A few months ago, five of Zhang’s former colleagues and subordinates were arrested on suspicion of taking bribes and another official was ordered to stay at home pending results of the investigation. Once again, China’s FDA shows signs that it may be incapable of fulfilling its watchdog function. We can hear the axe grinder now.

New England Healthcare Institute (NEHI), a nonprofit research organization with ties to the pharmaceutical industry, health insurers and academia, estimates that one third to one half of all patients in the U.S. do not take their medications as prescribed by their doctors. Actually, regarding that percentage, NEHI may be quoting the World Health Organization, which may be getting its figures from the pharmaceutical industry, which may just be making them up.

“Adherence” is the technical term used by the pharma industry for “following doctor’s orders” about taking medication. NEHI suggests many reasons for the poor “adherence” behavior of Americans, including:

• cost
• side effects
• the challenge of managing multiple prescriptions (polypharmacy)
• patients’ understanding of their disease
• forgetfulness
• cultural and belief systems
• imperfect drug regimens
• patients’ ability to navigate the health care system
• cognitive impairments
• a reduced sense of urgency due to asymptomatic conditions

“In general,” says NEHI, “adherence rates are lower among patients with chronic conditions than among those with acute conditions.” NEHI estimates poor adherence poses an increased risk of hospitalizations due to poor health outcomes, resulting in significant excess costs that are passed along to everyone via higher insurance/co-pay rates. “Since a full 75 percent of U.S. health care spending goes to the treatment of chronic disease, poor medication adherence presents a serious roadblock to efforts to improve health care efficiency and affordability.”

Not to mention the roadblock to increased pharma industry profits!

There have been many strategies to overcome poor adherence. Drug companies, for example, have incentive programs that include coupons for the partial or total re-imbursement of copayments.

A new strategy embraced by pharmaceutical companies, pharmacies and insurers, reported today in the New York Times, is a lottery whereby patients can win cash for taking their medication! “In a Philadelphia program people prescribed warfarin, an anti-blood-clot medication, can win $10 or $100 each day they take the drug,” reported the NYT (see “Cash Helps the Medicine Go Down“). The program uses a computerized pillbox to record if patients took the medicine and whether they won that day.

First of all, no computerized pillbox can actually know if patients swallowed the pill or merely threw it down the drain, which they might do if non-adherence was due primarily to bad side effects. For more about electronic pill boxes, see, “Can an In-home Electronic Pillbox Solve Our Medication Error Problem?”

You can, however, place an electronic collar around patients’ necks and detect if specially-designed pills were actually swallowed. As if that will ever happen! (See “Invasive Compliance: A Bitter Pill to Swallow.”)

Aside from gaming the system by throwing the pill down the drain, the lottery idea is intriguing. It is well-suited to the American psyche, which now expects bad behavior to be rewarded (as in getting great refinancing deals and government subsidies when you decide not to make your monthly mortgage payments). You can also look at this as rewarding good behavior, except I suspect that those patients who prudently have taken their medication all along are not included in such incentive programs.

I am waiting for such a program to be offered to the millions of men who suffer from erectile dysfunction and who “forget” to take their daily dose of Cialis! When that happens, I’ll be the first to sign up!

Read more here
Take Your Medicine, Win the Lottery! Void Where Prohibited.

A major catalyst is potentially on the (very) near term horizon for The Medicines Company (Ticker: MDCO). I stumbled upon MDCO a few weeks back from my daily market scans for unusual option activity. I investigated MDCO to determine the rationale (if any) for said activity and quickly determined that it had to do with the Patent Term Extension for the Company’s lead product, Angiomax. I will not go into the legal minutiae here but basically: Back in 2001, MDCO filed to extend the patent on Angiomax but filed the application electronically shortly after the close of business on the date of the deadline. Because it was filed electronically after the close of business on the day of the deadline, it was deemed to be filed one day late. As such, and according to law, the Patent and Trademark Office (“PTO”) denied the extension. As a result, MDCO “lost almost 5 years of earned patent protection with a value of roughly $1 billion.”¹

I mentioned that Angiomax is MDCO’s lead product – this is an understatement of epic proportions: Angiomax contributes over 99% of MDCO’s annual net revenue. The Company currently markets one other product and has several early and late stage product candidates in its pipeline. Loss of patent protection on Angiomax could thus be devastating to MDCO. As such, MDCO has been in a constant legal battle with the PTO, the FDA and U.S. Department of Health and Human Services for the past several years. The Company has also been aggressively lobbying Congress.

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▪ Physicians are concerned about patients self-diagnosing. This is especially true with younger patients who many found were not only self diagnosing but self prescribing by sharing medications.

▪ They feel that some patients who don’t like to come to the doctors office may use these websites to put off physician office visits which in turn could lead to more serious health problems.

▪ “You can’t generalize when it comes to health conditions”, one physician said. “Each patient has to be evaluated as an individual with a full range of diagnostic criteria” she said. “To suggest that other treatments maybe effective is an incomplete diagnostic evaluation and a reason that patients come to physicians”.

Now for a moment let’s take a step back and acknowledge that patients today are more empowered and there could in the near future be a shortage of PCP physicians. The question then becomes do sites like these help the patient more by providing more information and letting others see what is working for some or do they hinder credible medical care ? The answer to that is that probably a little bit of both. If even a small percentage of people use these sites to self diagnose and treat than they are risking their health that could and should be better diagnosed by a medical professional.

When it came to social media the physicians we interviewed were much more apprehensive. Some had pulled some bizarre claims on health “cures” and treatments from sites and were frankly amazed that bad information like this could be so prevalent . However the majority had said that they did not have any patients show up asking about miracle cures or treatments.

Physicians like empowered patients but they often do not have the time to really sit with patients and explain health conditions or different treatments. “I have to see as many patients as possible to make my practice profitable, stay up to date on new medications and medical information and still have time for CME and a life if very hard”. It’s ironic because at a time when some are asking patients to rate their physicians many feel they are being pressured to prescribe generic drugs and see more people which in turn means less quality time per patient.

Sites like Cure Together maybe a good way to bring patients together but more education is needed on prevention and ensuring that patients go to their physicians for annual check-ups and when they have a medical issue that they are concerned about. In this case I am sure that they would prefer that Cure Together means working with your doctor instead of other patients who may have different needs.

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Patients choice: But is it the best choice ?

His view was expressed in a May 6, 2009, e-mail to colleagues who asked about hiring someone to help with COI issues that have been “swamping me,” as one wrote in a different e-mail the same day (you can read them here). Insel wasn’t persuaded. “I think there are more urgent needs, with ARRA (American Recovery and Reinvestment Act) review and program demands,” he wrote. “Might make sense for us to have someone as consultant, but I don’t want to build a COI shop with several full-time professionals.”

Meanwhile, Insel himself is now facing the unwanted glare of attention thanks to reports earlier this week that he helped Charles Nemeroff – a prominent focus of the Senate probe – obtain a job at the University of Miami after being banned from accepting NIH grants at his previous employer, Emory University (see here). Nemeroff had accepted sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug.

In a blog post this week, Insel attempts to address the criticism – without mentioning Nemeroff by name – by noting that, unless academics such as Nemeroff are ‘debarred’ from accepting NIH grants, even those who violate existing policies remain free to apply for still more grants (and the University of Miami med school is presumably happy to embrace this stipulation if, thanks to Nemeroff, more research dollars will flow to its campus).

Insel also expresses surprise at “allegations that NIMH has not taken this problem seriously and that as director, I have failed to take action against those who have been accused,” and points to the newly proposed NIH rules, among other steps. (Earlier this week, he also denied having any “great relationship” with Nemeroff, who he has known for years). “As the steward of public funds at NIMH,” he writes, “I am committed to ensuring that we support science that is unequivocally in the public’s interest, unambiguously supported by the public trust.” Perhaps the commitment might have been even stronger – and his surprise lessened – if he had created that COI shop last year.

At the time, more than 20 consumer groups and non-governmental organizations wrote to India’s Minister of Commerce and Industry to complain the meetings are used as forums by companies to promote their IP and lobby for amendments to existing law or plead cases before the Indian Patent Office. Now, nine groups wrote GW to complain its India Project purports to be “an academic exercise and free-flow exchange of ideas, but instead act as a front for a biased industry agenda.”

The groups, which include Doctors Without Borders/USA, Oxfam America, Health Gap and Public Citizen, complain the India Project “failed to present a balanced discussion on intellectual property, and especially the importance of protecting public health in developing countries.” They also charge GW has “misrepresented an industry-centered perspective as an independent academic exercise,” since the project accepts funding from drugmakers and software companies, which have “vested interests” (here’s background that mentions Gilead Sciences as an example).

So what do they want?

They hope to convince GW officials to “resist the use of the university by industries interested entirely in commercial profits,” and to present a wider scope of IP issues that reflect a need to protect public health, as well as changing the patent system so more innovative meds for neglected diseases are produced and access to needed meds is widened (here is their letter). We are awaiting a reply from GW and will update you if, and when, the university responds.

The ties beween the two men, which reportedly go back a few years, appeared to be on display in a series of emails (see them here). One e-mail from Nemeroff to Insel last October discloses that he signed a contract for his new job and thanks him for his “friendship and support.” This was written two months after Insel wrote the University of Miami med school dean that NIH rules precluded him from providing a written recommendation, but he was “happy” to discuss Nemeroff “informally by phone.”

Today, however, Insel tells The Washington Post that the story is a “little surreal” and he didn’t have “any great relationship” with Nemeroff. What Nemeroff “had done was so outrageous, he became the poster boy for conflict of interest.” He goes on to insist that “I didn’t recommend him” to the University of Miami, but only clarified Nemeroff was not barred from applying for future NIH grants. Nemeroff may have “penalized” by Emory, but he “jumps to another (university). I can see why Senator Grassley is upset,” he added. “I would be upset at that, (but) we can do nothing about the individual. The grants are given to the institution.”

One can imagine that Grassley and his staff, which are already probing Insel and NIMH grants, will spend time looking at any connections between Insel and Nemeroff…

By way of background, Nemeroff departed Emory last year after the Senate probe disclosed he was accepting sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug. The Department of Health and Human Services Office of Inspector General is conductding its own inquiry.

In a filing this week, J&J asked a judge to dismiss the January 15 lawsuit by saying the government is arguing that allowable rebates are actually illegal under the Anti-Kickback Statute. “This case is a remarkable attempt to attack common discounting arrangements that are expressly protected under federal and state law,” the healthcare giant maintains. Meanwhile, Omnicare last fall settled civil claims that it accepted kickbacks by agreeing to pay $98 million, although the pharmacy never addmited liability (see here).

Nonetheless, J&J maintains that offering customers higher rebates based on market share or usage in hopes of winning formulary placement is not out of the ordinary. The government and the whistleblower, former Omnicare pharmacist Bernard Lisitza, “seek to penalize (J&J) for the use of standard and lawful formulary and disease management practices that the federal and state governments themselves routinely use,” J&J argues. “Today, rebates remain standard industry practice and are absolutely essential to our health care system.”

The US didn’t charge Omnicare made any factually false claims for Medicaid reimbursement or falsely certified conditions were met to participate in the program, according to J&J, which also charged the government failed to link kickback claims to improper switching of patients to Risperdal without the approval of doctors.

“Their response misses the point of the government complaint,” Michael Behn, Lisitza’s lawyer, tells Bloomberg News. This “ignores the overwhelming evidence that the point of Johnson & Johnson’s payments was to steer nursing home patients to Risperdal.” Lisitza claims he was fired after complaining about patient switching.

One exhibited contained in the lawsuit appears to raise the issue of off-label promotion (see this).

Pfizer trying to reestablish trust with a skeptical public

Pfizer has been running banner ads online to try and reestablish trust with its customers. With the tag line “working for a healthier world” Pfizer has set up a website with content on R&D, Health and Wellness, and Responsibility. The problem of course is that the public, for the large part, sees this as a shallow words. They want big pharma to stay out of the media for putting sales ahead of patients.

However the Food and Drug Administration has just warned Pfizer for failing to quickly report serious and unexpected potential side effects from its drugs already on the market. In a 12-page warning letter to Pfizer Chief Executive Jeffrey Kindler, the FDA cited numerous examples involving some of the company’s top-known brands, including impotence drug Viagra, cholesterol pill Lipitor and seizure medicine Lyrica. The delays in reporting side effects date back as far as 2004 and have grown in recent years, according to the FDA’s letter that was released by Pfizer today.

A website targeted at reestablish a drug company patient relationship. Consumers see these as just words that need to be backed up with actions.

So how can pharma restore trust with a skeptical public ? Here are some things that I believe they can do:

• Show the faces of those your medication helped: More patient stories of those who are leading better lives because of the prescription drugs they take or treatments they received. Remember Lance Armstrong’s commercial for BMS ?

• Acknowledge that all drugs, whether prescription drugs or OTC products, have side effects and that none are perfect for everyone: The story last night on the evening news about ibuprofen causing an increase in the rate of heart attacks clearly tells consumers that drugs, whether OTC or Rx, all have risks. The drug industry needs to acknowledge what patients already know.

• Provide additional value to your customers: The drug industry needs to stop thinking mass marketing and start thinking more one on one marketing, especially to current patients. This means a deep development of CRM programs that add value to patients in the form of new clinical trial results on current medications, as well as helping consumers cut through the fact and garbage when it comes to health news.

• Use social media: At least use it to listen to your customers and if your health condition warrants it use it to bring people together to talk about your brand and share their experiences.

• Acknowledge that it’s going to take time: Trust cannot be restored overnight. It takes time and consistency of actions. CEO’s and senior executives should be meeting with the rank and file to clearly state “patients come first” and anyone who compromises that principle has no place at this company.

Do you see a pattern here ? It’s reaching out and talking to consumers like people not segments. It’s admitting that we all are human and can make mistakes and ask for forgiveness when these mistakes happen. It’s putting a human face on the good the drug industry has done and can continue to do if patients understand the risks of not doing anything or taking drugs. Times have changed and the drug industry desperately needs to change the way they talk to consumers.

To the public this maybe seen as sheer hypocrisy

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Pfizer tries to earn back consumer trust the same day they get a warning letter from the FDA

You may recall Nemeroff, who was recently hired by the University of Miami, had departed Emory University after the Senate probe disclosed he was accepting sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug (see this). Before his departure, Emory imposed a two-year ban on grants for on Nemeroff. This week, however, the U of Miami med school head, Pascal Goldschmidt, was quoted as saying the ban was “an immediate reaction to political pressure” (see here).

Angered at the remark, Grassley has sent a letter to Donna Shalala, the University of Miami president and a former US Secretary of Health and Human Services to say “I hope that you would agree – contrary to Dr. Goldschmidt’s views that disciplining researchers for failing to disclose conflicts of interest is merely a political issue – that enforcing federal conflict of interest policy iinvolves ethical and legal issues that ensure taxpayer trust.” Grassley wants Shalala to provide all conflict of interest forms filed by Nemeroff, as well as all e-mails and communications by Goldschmidt and Nemeroff’ about conflicts and NIH grants.

But there’s more. Grassley also wrote a letter to HHS Office of Inspector General Dan Levinson to examine the ties between Nemeroff and NIHM director Tom Insel. Insel apparently helped Nemeroff win his job at the University of Miami (see this) and Levinson is already investigating Nemeroff (look here). Ironically, the NIH has just proposed new rules on conflicts, although Insel is one of Nemeroff’s long-standing allies and he was on the panel that reviewed the new rules (background).

First let me say that TV, as a channel for marketing, is not dead. It’s a great way to raise awareness of new products. However, once that awareness has reached a certain level marketers need to think about pulling consumers into the brand. For DTC marketers this has usually meant print ads or more TV ads that have little ROI (i.e. Cialis for daily use). While consumers look for more information and consult with others via social media pharma marketers, for the most part, continue to think “mass market”.

So how could pharma market to the individual:

• Print Ads-Why use the same print ad in a number of different publications when the demographics and psychographics are different. Why, instead of doing a standard print ad, doesn’t pharma use more advitorials to magazines that give consumers key information THEY want and help them cut through the clutter of all the health information on the Internet ?

• Internet: The standard rule of thumb for pharma marketers seems to be to develop a website and then purchase some keywords to drive traffic to the product website. Sorry but is Web 1.0. Today you need multiple home pages, each dedicated to a microsegment of visitors integrated with specific key words. You also need intuitive navigation on your website which is navigation arranged in the same way consumers go through the thought process of “do I want this product?”

• Internet advertising: If you’re advertising on the Web you should have a lot of different executions of online ads customized for each website’s audience. One ad does not fit all websites.

• Social Media: Instead of having one social media site you should have different social media sites for each microsegment that addresses the key barriers to conversion.

In my presentation The End of Mass Marketing I talk about some of the things that marketers can and should do today to make marketing more efficient and keep customers. If consumer packaged goods marketers lost as many customers as pharma they would be out of business. Stop thinking masses and start thinking individuals.

The End of Mass Marketing

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Can drug companies market one on one ?

By Michael Fitzhugh

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The disclosure comes just as a report was released today by the Council of Europe, which harshly criticized the lack of transparency around the handling of the swine flu pandemic. The WHO’s actions led to a “waste of large sums of public money, and unjustified scares and fears about the health risks faced by the European public….(and there was) overwhelming evidence that the seriousness of the pandemic was vastly overrated by WHO,” resulting in a distortion of public health priorities.
according to the report from the Social, Health and Family Affairs Committee of the Parliamentary Assembly of the Council of Europe (see the report here and the statement here).

Ironically, it is almost a year to the day that WHO director Margaret Chan declared a pandemic. Since then, the WHO, which called the inquiries “conspiracy theories,” has been besieged by accusations and PACE called the agency “highly defensive.” The BMJ noted that WHO asked for conflicts of interest forms prior to meetings held by its experts, but their ties to drugmakers were never publicly disclosed. The WHO refused to make the forms available to the BMJ. Meanwhile, the 16 members of an “emergency committee” that advised Chan on declaring a pandemic was kept secret, so any connections to industry remain under lock and key.

Oddly enough, the WHO yesterday recommended that the H1N1 pandemic remain at a Phase 6 alert, which is the highest level, and its expert committee will meet again next month for a reassessment (see this). At the same time, Chan says the name of its committee members will be disclosed once its work is completed. Why not now? “The purpose of this practice is to protect the integrity and independence of the members while doing this critical work, but also to ensure transparency by publicly providing the names of the members as well as information about any interest declared by them at the appropriate time. The committee members strongly concurred with this approach.” So Chan’s idea of transparency is to not release the info until later. What do you think?

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The data actually combine two studies involving 1,092 men who were asked to have at least three sexual encounters and suffered premature ejaculation at least twice prior to the Shionogi experiment (see the press release). The International Society for Sexual Medicine defines PE as the inability to delay ejaculation for more than 1 minute after vaginal penetration and, supposedly, up to one-third of US men suffer.

Shionogi measured success two ways – the Intravaginal Ejaculatory Latency Time, as discussed above, and a patient survey that asked about distress, control and satisfaction. The men responded that PSD502 yielded improvement across the board, although so did the men on placebo, just not to the same extent. Side effects included 3.1 percent reporting loss of erection and 5 percent of the partners complaining of a burning sensation. Why that burning feeling? Ira Sharlip, a Shionogi consultant and clinical professor of urology at the University of California, San Francisco, posits that women “were having more intercourse than they usually have.”

The spray, by the way, combines lidocaine and prilocaine, two local anesthetics, along with the propellant, atlhough Shionogi has no idea how it works. Nonetheless, Shionogi hopes to capitalize on a market that, like erectile dysfunction, is sure to generate substantial publicity and interest, especially since there is nothing currently available in the US for PE. Shionogi, in fact, worked overtime this past weekend at the American Urological Association to garner coverage of its data.

Nonetheless, the drugmaker can still expect some skepticism, despite the ISSM definition. “It would seem to be an entirely subjective measure, so that one man may say that it’s within 2 minutes and another may say that it’s within 10 minutes. How much is culturally determined?” says Joel Lexchin, a professor at York University’s School of Health Policy & Management. “This strikes me as a bonanza for any company that can get a drug approved for this condition, since the company will try and set a standard time and any man that doesn’t meet that time is a potential user of the product.”

The survey also found that older, often less expensive SSRI antidepressants – selective serotonin reuptake inhibitors such as Lexapro, Celexa, Prozac and Zoloft – work just as well, and with fewer side effects, than newer, more costly SNRIs, including Cymbalta and Effexor (see Consumer Reports cost data here). Last year, doctors prescribed $9.9 billion worth of antidepressants, a 3 percent increase, according to IMS Health.

“Our survey shows that a combination of therapy and medication works best, and that despite the intense marketing push consumers are subjected to,” Nancy Metcalf, senior program editor for Consumer Reports Health, says in a statement, “there is no evidence that newer drugs like Pristiq and Cymbalta work any better than older medications in their class.”

Among those taking SSRIs, 53 percent say they helped “a lot,” compared with 49 percent given SNRIs. As to side effects, 31 percent of those on SSRIs reported sexual side effects, 16 percent cited weight gain and 12 percent had sleep problems. Of those taking SNRIs, 36 percent reported sexual side effects, 22 percent had weight gain and 16 percent cited sleep problems. Wellbutrin, which is also known as Bupropion and is neither an SSRI nor an SNRI, helped 48 percent of respondents “a lot.” In terms of sexual side effects and weight gain, it was tolerated better than the SSRIs and SNRIs.

Recently, Novo Nordisk (NVO) announced that Victoza (liraglutide), a once-daily injection for the treatment of type II diabetes in adults, has been approved by Health Canada, a department of the Canadian government responsible for national public health.

The drug, the first human glucagon-like peptide-1 (GLP-1) analogue, has been approved for treating adults suffering from type II diabetes to improve glycemic control in combination with metformin or metformin and a sulfonylurea. Glycemic control refers to the levels of blood sugar (glucose) in a person suffering from diabetes mellitus.

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Bisaro claims the FTC harassed his company and used confidential FDA info in an effort to force Watson to strike a deal with Apotex, another generic drugmaker, to sell a version of Cephalon’s Provigil, a sleep-disorder drug. The FTC is challenging a 2005 deal between Cephalon and several generic drugmakers that were paid $300 million by arguing the payments bought market exclusivity.

His charge follows a subpoena sought last year by the FTC to compel Bisaro to respond to questions in connection with an investigation into that deal. The FTC says Bisaro refused to testify. Bisaro, however, claims the FTC is making “an improper attempt to broker a new business deal” between Watson and Apotex that would “improve” the market, rather than any legitimate pursuit of the FTC’s statutory mission of policing anticompetitive deals (you can read the documents here, here and here).

The filing, which was first reported by MM&M, goes on to claim that Markus Meier, assistant director of the FTC Bureau of Competition’s Health Care Division, “not only suggested that Watson should pursue a business deal with another generic pharmaceutical manufacturer, he expressly warned Watson’s counsel that Watson’s failure to pursue the FTC’s suggested course would likely cause the FTC ‘Front Office’ to initiate an investigation. There can be no dispute that prosecuting the subpoena is retribution for Watson failing to pursue the FTC’s desired business strategy would constitute an abuse of process…The FTC’s pursuit of the subpoena demonstrates that its conduct is nothing short of harassment.” Watson is now pressing the court to be allowed to seek info on the FTC’s contact with the FDA and Apotex.

Last night I had the honor of hosting the #socpharm “Tweetchat” session, standing in for Eileen O’Brien (@EileenObrien; Siren Interactive) who is the founder and regular host of that Twitter discussion stream.

One issue discussed in last night’s session was Sara Baker, a “fake” patient created by MedSeek, an eMarketing company that does work for the pharma and healthcare industries.

“Meet Sara Baker,” says MedSeek on its website. “ePatients like Sara Baker are the future of eHealth. She uses the Internet to stay connected with friends, check her bank balance and make purchases. She is Web-savvy and expects her healthcare provider to be, too. She has growing expectations of her healthcare providers for 2011 and beyond. And she will be the driving force behind your healthcare organization’s ePatient revenue center.” emphasis added

MedSeek even created a Facebook page/personna (eSaraBaker) for Sara where she posts things like “Just found out my hospital is adding a new online feature starting June 1: Now I’ll be able to log in one time to manage everybody’s appointments, prescriptions, etc. Me, Alex, Brad and Jake… all in one place. How great is that?”

Phil Baumann (@PhilBaumann) first called attention to this marketing ploy that “promises to deliver revenues to healthcare organizations wishing to market to so-called ePatients.” Baumann coined the term “fPatient” to distinguish the likes of Sara from real ePatients (see “fPatient – Ethics and Mediocrity in Healthcare Marketing“).

The #socpharm discussion of Sara Baker lead to a discussion of the use of “fake” patients on drug.com websites, something I have written about many times here on Pharma Marketing Blog. See, for example, “Alice, 35, is Not a Real Ambien CR Patient.” After I wrote that piece, sanofi-aventis added the disclaimer “Not a real patient” to the animation on the site. Since then, however, they have moved away from images of “fPatients” to roosters. Oh well.

The trend today, however, is to solicit and portray real patient stories. See, for example, “Barb” on the Novartis Reclast site. She’s featured in a “Dramatic Health Production” video in the “Real Reclast Stories” section of the website (here).

Although Barb is real, there are other “patients” featured on the website who may not be real. Take “Rhoda” for example. There’s a written profile of Rhoda, but I can’t find her in the “Real Stories” section. Is she real or fake? I can’t say for sure one way or the other.

Obviously, actors are used in direct-to-consumer (DTC) Rx drug ads all the time. Sometimes, we are lead to believe that actors playing doctors in TV ads are real doctors or actually rowing when they are not (see “Jarvik: A Modern DTC Tragedy“). On TV we also see actors portraying patients. Sometimes they even speak and say how the drug helped them. Most often, however, these “patients” don’t really say anything. They certainly are not identified by name and age as is the case with “Rhoda” and other questionable “patients” on drug.com websites.

Is it ethical for pharma marketers to employ “fpatients?” Is it even necessay? asks Baumann: “Is the deployment of fake profiles in Healthcare Marketing even necessary? Marketing not only has to be effective, it also has to be respectable. Why create a fake social object when so much more social capital can be built by simply being honest and truthful and direct? Why not take advantage of direct interaction and feedback?”

We might have to wait until hell freezes over before pharma marketers are “honest and truthful and direct” let alone before they “take advantage of direct interaction and feedback.” Like the Reclast marketers, however, pharma marketers will go on location to videotape a real patient and create a well-crafted, edited video profile that they can feature on their websites and on YouTube for extra-added search engine benefit. You can’t get that kind of ROI from “truthful, direct, honest interaction.”

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Nobody Knows You’re a Fake Patient on the Internet!

“I am especially concerned because so many of the drugs at issue in this recall were intended for infants and children,” Harkin (see photo) wrote in his letter to FDA commish Margaret Hamburg. He did not indicate, however, plans to hold a hearing. The House Committee on Oversight and Government Reform will question FDA deputy commish Josh Sharfstein and Colleen Giggins, who heads J&J’s global consumer business on Thursday (see this).

J&J’s McNeil unit was cited for quality-control problems that affected about 40 over-the-counter meds for infants and children, and failed to properly follow up complaints that certain batches of its Tylenol Arthritis Relief Caplets had a musty smell. Earlier this month, J&J closed down a McNeil facility in Pennsyvlania to cope with the problem.

The plan comes as other European governments raise drug prices in the face of huge deficits. The UK’s National Health Service, for instance, is predicted to face a shortfall of more than $28 billion, suggesting the willingness to set price controls will add significant pressure on the pharmaceutical industry sooner than later. The notion, however, isn’t news. Back in 2007, the UK Office of Fair Trading recommended that prices paid by the NHS should reflect therapeutic benefits.

“A price-control policy has not been fleshed out…but the fact that it has been mentioned in the context of NICE reform should be considered as the main – and perhaps inevitable – threat to the pharmaceutical industry in the UK going forward,” IHS Global Insight healthcare analyst Milena Izmirlieva, tells Reuters. “We are keen to begin talks with the government about how this can be achieved,” a spokesman for the Association of the British Pharmaceutical Industry tells PharmaTimes, “but it’s not going to be an easy road.”

The agency’s views have yet to be heard, but there’s already plenty of debate in women’s health circles about the prospects of a new drug to treat a condition that some find questionable. The clinical term for the condition is hypoactive sexual desire disorder, or HSDD, a loss of sexual desire which could affect up to 10 percent of all women.

Boehringer gathered data on more than 5,000 pre-menopausal women and determined that the group taking flibanserin achieved an average of 4.7 satisfying sexual experiences a month compared to 2.7 before they were treated and 3.7 in the placebo group. The company is likely to face some tough questions on the narrow difference of response seen between the drug group and the placebo group.  

“Achieving a happy and healthy sex life can be a real and important problem for some women,” Amy Allina of the National Women’s Health Network tells the Washington Post. “But we have lots of questions about the ‘pink Viagra.’”

The agency’s committee on reproductive health drugs meets June 18.

- here’s the article from the Washington Post

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FDA panel review looms for controversial libido drug

If you were a diabetes patient would you want to enroll in a clinical trial for a drug that potential life threatening side effects ? Obviously the people at Glaxo live in a sheltered world where they can be protected from reality. Meanwhile, Glaxo has been adding sites in several developing nations. Safety advocates and some regulators have said the trial, called TIDE, is unethical because patients are being given a drug already linked to serious cardiovascular problems. Does Glaxo really believe that it’s ethical to take the trial outside the US where all too often people enroll in clinical trials because of economic conditions ?

Glaxo said any major safety problems are unproven and called Avandia a valuable option for some patients. What Glaxo doesn’t understand that it’s too late to come out with data to prove or unprove side effects. The damage is done to this brand and people are not going to switch back to a drug they perceive as dangerous to their health. Once again Glaxo is ignoring what people want and doing what is best to protect their financial interests. Physicians are not about to prescribe Avandia and patients, who are not consumers of healthcare, are not about to ask for Avandia. I would have expected that Glaxo would have seen the writing on the wall but then again they tend to live in their own little world that has little basis in reality.

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Glaxo needs to pull the plug on Avandia: the damage is too extensive

-Patients treated over long periods with metformin, a common drug for diabetes, are at risk of developing vitamin B12 deficiency which is also likely to get worse over time,

-Drugs to lower cholesterol and prevent heart disease, taken by millions of people worldwide, increase the risk of cataracts, kidney failure, muscle pain and liver dysfunction,

-Research published this week in Archives of Otolaryngology-Head and Neck Surgery showed an association between long-term hearing loss and Viagra. If you’re a patient concerned about drug side effects what are you going to do ? You’re going to go online and try to decipher all this information.

This week we found out that Google is second to physicians as a source of health information (DUH!). Since Google is the nuber one search engine and since more people are going online this data is obvious. If you’re a patient taking a prescription drug and you’re reading these news reports you’re probably wondering what in the wide wide world of a sports is going on here ?

What in the wide world of sports is a going on here ?

After asking where people turn to for health information, a poll asked which sources they trust. Health advocacy groups emerged as a particularly trusted source of online health information: 71 percent judged Web content of such groups “somewhat reliable” or “extremely reliable,”considerably higher than the 59 percent who felt that way about organic Google searches.

Online communities aren’t yet a major influencer in health care. Only 12 percent of respondents used online forums in their last search for health information, and only 37 percent considered forums “somewhat reliable” or “extremely reliable.” Of those who did look to online communities, the number one reason was their around-the-clock availability.

If this is news to you then marketing is probably not a good career path for you. In reviewing this news, however, it does tell us somethings about the way consumers are using the Internet for health:

1. People trust each other a lot more than they trust pharma companies or the FDA

2. Social media is not yet a major factor in healthcare decisions. However we need to evaluate both the online communities in relation to the seriousness of the health condition before writing social media off as channel that can influence patients and consumers.

Now for a second put yourself in a consumer/patients POV taking one of the drugs that has recently been highlighted in the news for possible new side effects. Where do you turn ? Who do you trust ? You certainly aren’t going to make an appointment with your physician to “discuss” this news because in all likelihood he/she doesn’t have enough information. Do you stop taking your medications ? Do you ask to switch to another brand ?

The media report on statins does go as far as saying that the benefits of statins far outweigh the risks but for nervous patients that isn’t going to make them feel a hell of a lot better. This is where pharma companies can step up and provide their customers with answers. Answers in the form of credible sources of information (via links to third party sites) and sources via a discussion online between thought leaders and patients. It has to be done quickly because a lot of people may stop taking their medications when they read the headlines while others will go online to try and interrupt the studies.

Pharma needs to step up to the plate and respond quickly and with good credible sources of information. It’s a chance to start earning back the trust of a skeptical public.

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When will Google surpass physicians for health information ?

The move follows an ongoing probe by the US Senator Chuck Grassley of the Senate Finance Committee, who uncovered several examples in which academic researchers accepted funding from both the NIH and various drugmakers, but failed to fully or properly disclose the extent of their financial ties. At the same time, several universities failed to monitor their faculty for conflicts. At the heart of the issues is concern that healthcare providers are being unduly influenced by iindustry. The research generated by funding from the NIH and drugmakers often finds its way into medical practice by way of presentations and medical journal articles, especially those proferred by high-profile experts who often form relationships with one or more companies.

“The way in which science is moving forward, in order to be successful, partnerships between NIH funded researchers and industry are essential, they have been and will be, but we need to preserve the public trust,” NIH director Francis Collins told the media in a briefing this morning (listen here). “We believe, in the past, that the process followed has, for the most part, been succcessful. I don’t mean to imply I think there is a widespread problem, but there clearly have been a few examples in the last few years that …could be perceived as coloring their judgment in projects there were involved in.”

He didn’t mention names, but one example involved the former psychiatry chair at Emory University, Charles Nemeroff, who failed to report hundreds of thousands of dollars in payments from a drugmaker while researching the company’s drugs with an NIH grant (see here). There were several other high-profile episodes that you can read about here, here, here, here and here. Recently, Grassley also targeted the National Institutes of Mental Health specifically (see this).

As part of the proposal (here it is), a researcher whose holdings may be deemed a significant financial conflict of and exceed $5,000 should be reported to the university or institution that employs the researcher. According to current NIH regulations, the reporting threshold is $10,000. What’s significant? The aggregate value of, say, stock holdings, consulting or speaking fees, patent rights and royalties. The holdings must be reported on a web site run and updated regularly by the university or institution, and the amount of the researcher’s holding would be listed in dollar ranges: less than $20,000; less than $50,000; less than $100,000; lless than or equal to $250,000; greater than $250,000.

Institutions that fail to comply may see NIH grant funding suspended or terminated, although the actual enforcement mechanisms were not spelled out. In a statement sent us, Grassley called this “a step in the right direction.”