The issue as with all drugs is benefit/risk ratio. Avandia may cause a heart attack just as aspirin may cause a stroke or intestinal bleeding. The issue is how many heart attacks we should accept versus the serious risks from poorly controlled diabetes.

The harsh reality of drugs is that they have side effects and risks. There are no completely safe drugs. There may be real issues with Avandia’s benefit/risk ratio and I am not downplaying the issues raised by critics. The feeding frenzy from lawyers and drug critics seeking a new scapegoat for drug company evil is what bothers me. Since Avandia was a DTC drug we can also expect new calls for bans based on claims that consumers were led to take ”dangerous” Avandia by DTC ads.

I have been a critic of how risk is regulated by FDA. People need to know the real odds of a serious side effect, not vague terms describing every potential risk. If a diabetes sufferer well-controlled on Avandia is given the odds of them suffering a heart attack, they can make the decision with their doctor. My guess is that the real odds of increased risk are quite small. The media will report figures like a 50% increased risk of heart attack which sounds horrible to consumers. In reality that may mean 1.5 in a thousand get a heart attack versus 1 in a thousand not on the drug.

I sympathize with Glaxo’s plight because I was on the Rezulin team in the late 1990’s when we faced the same issue. Rezulin, in the same class of drug as Avandia, was associated with fatality. As I recall the level of fatality was one in thousands, but since alternative drugs existed, it was pulled. The lawyers had a feeding frenzy and a good drug was no longer available for the many patients it helped.

To the person getting a rare side effect the consequences are devastating. We cannot, however, have life saving drugs if we will not accept that some people may actually die taking those life saving drugs. The question is always how many die versus how many saved? Much of the latest criticism of Avandia has been hyped to the point that it will scare diabetics from treating their disease. If Avandia has a negative risk benefit profile it should be withdrawn but not because of lawyers and knee-jerk critics but because of hard facts. I now see commercials from lawyers seeking “harmed” Avandia patients. Glaxo may face billions in potential liabilities as lawsuits grow exponentially. These lawsuits raise the cost of our medicines as eventually all of us pay for liability settlements in higher prices.

We can also expect new Congressional hearings on drug safety so our legislators can get face time bashing executives on what they knew and when did they know it. The Avandia commercials will be shown as examples of demand creation for a dangerous drug. Waxman will call for a moratorium on drug ads. Sidney Wolfe will cry cover up of key clinical information. No critic will be dealing with facts just hyperbole du jour. That is a sad reality in the world of drug makers.

After delaying its debut two days, Aveo unloaded its initial public shares for $9, far less than the $13 to $15 range it had hoped for. That means the developer raised $81 million and has a market value of $267 million. The cancer drug company is currently in

Well, have a look at this garage, which is said to be somewhere in Silicon Valley. I don’t have any reason to believe the photos are faked; you could certainly put your hands on this kind of equipment very easily in the Bay area. The rocky state of the biotech industry just makes things that much more available. From what I can see, that’s a reasonably well-equipped lab. If they’re doing cell culture, there needs to be some sort of incubator around, and presumably a -80 degree freezer, but we don’t see the whole garage, do we? I have some questions about how they do their air handling and climate control (although that part’s a bit easier in a California garage than it would be in a Boston one). There’s also the issue of labware and disposables. An operation like this does tend to run through a goodly amount of plates, bottles, pipet tips and so on, but I suppose those are piled up on the surplus market as well.

But what are these folks doing? The blog author who visited the site says that they’re “screening for anti-cancer compounds”. And yes, it looks as if they could be doing that, but the limiting reagent here would be the compounds. Cells reproduce themselves – especially tumor lines – but finding compounds to screen, that must be hard when you’re working where the Honda used to be parked. And the next question is, why? As anyone who’s worked in oncology research knows, activity in a cultured cell line really doesn’t mean all that much. It’s a necessary first step, but only that. (And how many different cell lines could these people be running?)

The next question is, what do they do with an active compound when they find one? The next logical move is activity in an animal model, usually a xenograft. That’s another necessary-but-nowhere-near-sufficient step, but I’m pretty sure that these folks don’t have an animal facility in the basement, certainly not one capable of handling immunocompromised rodents. So put me down as impressed, but puzzled. The cancer-screening story doesn’t make sense to me, but is it then a cover for something else? What?

If this post finds its way to the people involved, and they feel like expanding on what they’re trying to accomplish, I’ll do a follow-up. Until then, it’s a mystery, and probably not the only one of its kind out there. For now, I’ll let Dyson ask the questions that need to be asked, from that NYRB article linked above:

If domestication of biotechnology is the wave of the future, five important questions need to be answered. First, can it be stopped? Second, ought it to be stopped? Third, if stopping it is either impossible or undesirable, what are the appropriate limits that our society must impose on it? Fourth, how should the limits be decided? Fifth, how should the limits be enforced, nationally and internationally? I do not attempt to answer these questions here. I leave it to our children and grandchildren to supply the answers.

The Wall Street Journal reported the resistance at the end of a lengthy piece today on the bullish

Is FDA still listening about social media and medical products?

The deadline has passed (February 28), but a new submission was posted – this time from Yahoo! to the FDA’s Social Media Docket that was set up in the wake of the November Part 15 meeting related to the use of the Internet and social media in medical product promotion.  In fact, however, it is about social media use at all, not just for promotion, but for education – the fact that the title never reflected that might reveal a biased mindset on the part of the FDA, but that is neither here nor there for now.

The Yahoo! submission quoted back to FDA some of the usual statistics and some I had not heard before including:

• 91 million Americans use the Internet to access health information at over 1700 sites (had not heard that one);
• 78% of Americans suffering from a medical condition who are online visit a health-related website to learn about their condition and 56% of caregivers do the same;
• And quoting Manhattan Research, the number of Americans researching prescription drugs online has doubled since 2005 to 102 million people.

They then provided some insights into their own internal research on Internet use as it relates to prescription drugs.

“Over half of online Americans are on prescription medication with a fifth having done some research regarding some prescription drug medication.  Patients are learning about new prescription drugs through a plethora of sources – both online and offline.  However, online searches were the second most popular way these consumers obtained prescription drug information at 28%, compared with 44% who learned about the drug from their doctor and 24% who learned about a drug from a pharmacist.  Search is a clearly common and mainstream way for consumers to obtain drug information and the online space is becoming a key driver in how consumers are learning and researching about medication.”

You may be wondering why there are still documents appearing in the docket despite the fact that the docket was closed on February 28.  So was I, so I asked Dr. Jean Ah-Kang, Special Assistant to DDMAC’s Tom Abrams.  You may recall that it was my March 2009 podcast with her that began the public dialog with FDA on the issue of social media.  Here is what she said today about the status of submissions and the late entry by Yahoo!

“The Yahoo! submission was submitted prior to the deadline and just posted yesterday due to some technical issues… The docket is technically closed, and people will not be able to submit electronic comments on regulations.gov since that is no longer an option (the “Submit” function is not available through our docket).  However if someone is still very interested in submitting comments, please ask them to contact me directly – thanks!

She also indicated that the Division of Dockets Management reviews each submission prior to posting for all dockets, which means that there is a lag time between the time of submission and posting.  Electronic submissions will go through more quickly than hard copy.

Dr. Kang’s email address is Jean-Ah.Kang@fda.hhs.gov

And one hopes that in the future, FDA ditches Regulations.gov.  It is cumbersome.  It is not user-friendly.  And, it is not timely.

Read the original here
Yahoo! Submits Document to FDA Social Media Docket and Status of Submissions

AutekBio signed up with SUMA Ventures and Beijing E-Town Harvest International Capital Management Corporation, a venture capital group operated by the Beijing Municipal Government, in orchestrating the research and manufacturing project. AutekBio has kept a low profile, at least in the U.S. Li’s resume includes stints at Hoffmann La-Roche and Asterand. Back in 2007 the Beijing/Bay Area hybrid reported raising $1.1 million to help build its business growing cell lines for drug companies. China has become a hotbed of biopharma activity in recent years, with some of the world’s biggest players making ambitious plans to develop and manufacture therapeutics in the country.

“I am extremely pleased with this joint investment. This will allow us to build one of the largest biologic CMOs in Asia,” said Julius Li, the CEO of AutekBio, in a statement. “The newly established facility and company will provide, for the first time, manufacturing services in China fully conforming to the FDA,EMEA (and) cGMP standards for the global biopharmaceutical needs.”

- check out the AutekBio release

Related Articles:
China’s vax industry poised for rapid growth
China launches biotech VCs, new tech stock market
China gets serious about biotech

Now, there most certainly were secret LSD experiments during the 1950s and 1960s. (The book Storming Heaven has a good account of them, as well as of the history of LSD in general). But it’s rather hard to see why the CIA should decide to dose some village in the Auvergne, especially when the symptoms (burning sensations in the extremities as well as hallucinations) seem to match ergotism quite well.

But no matter. I think we can dispose of this new book and its author pretty quickly. Just take a look at some of his scoop:

However, H P Albarelli Jr., an investigative journalist, claims the outbreak resulted from a covert experiment directed by the CIA and the US Army’s top-secret Special Operations Division (SOD) at Fort Detrick, Maryland.

The scientists who produced both alternative explanations, he writes, worked for the Swiss-based Sandoz Pharmaceutical Company, which was then secretly supplying both the Army and CIA with LSD.

Mr Albarelli came across CIA documents while investigating the suspicious suicide of Frank Olson, a biochemist working for the SOD who fell from a 13th floor window two years after the Cursed Bread incident. One note transcribes a conversation between a CIA agent and a Sandoz official who mentions the “secret of Pont-Saint-Esprit” and explains that it was not “at all” caused by mould but by diethylamide, the D in LSD.

Laughter may now commence. For the non-chemists in the audience, diethylamide isn’t a separate compound; it’s the name of a chemical group. And LSD isn’t some sort of three-component mixture, it’s the diethylamide derivative of the parent compound, lysergic acid. (I’d like to hear this guy explain to me what the “S” stands for). Diethylamides have no particular hallucinogenic properties; they’re too small and common a chemical group for anything like that. DEET, the insect repellent, is a common one, and there are plenty of others.

In short, neither the author of this new book, nor the people at the Telegraph, nor the supposed scientific “source” of this quote, know anything about chemistry. This is like saying that the secret of TNT is a compound called “Tri”. Nonsense.

Researchers said that the 19 patients selected for

Shirley Ledlie, aka “Ann Adams”, “Julie Kahn”, “Jasper Boon”, and who-knows-how-many-more-phony-FB-aliases — the patient who claims sanofi-aventis (S-A) mislead her about the side effects of cancer drug Taxotere (see “sanofi aventis Feels the Social Media Pain. But Is It Authentic?“) — is laying siege to S-A’s VOICES Facebook page. Maybe some of these other people are real friends of Shirley and not just fake FB accounts. Only Shirley knows for sure. She has recruited at least one real person– her daughter — to post for her:

“Hello John,” Shirley posted to my FB Wall yesterday, “just to tell you your freind (sic) was right. The SA voices is the real deal. I posted and the same day my post had vanished and i was blocked. So i posted again and within 5 mins my other name was blocked and removed. I think they have someone sitting there waiting for me – so my daughter is going to post for me while i open another account.”

Today, the VOICES page is flooded with messages from Shirley et al similar to this one posted by “Julie Kahn”:

“If your company is typical of the blinkered attitude that big drug companies take when faced with genuine grievances from the poor people that have suffered by using your products – well no wonder that intelligent people are so cynical about the merits of the huge pharmaceutical machine.

“Just because things test fine on the poor animals that are… See More… See more used does not mean that humans will also do well on them. You need to modify certain things with Taxotere and you should be falling on your knees thanking some of these women who have information that will help you. Surely feedback like theirs is vital to your organisation. If you truly cared about improving people’s lives through your product you would contact these women and find out about their stories – not just delete their posts and pretend that all is fine in the Sanofi-Aventis garden”

You can find all the posts by visiting the VOICES FB page, but in case they are removed by S-A, I’ve collected them here.

The VOICES FB page is a legit S-A page, which focuses on support of Deep Vein Thrombosis (DVT) prevention and awareness. This is an unbranded site. VOICES is an acronym for Vitalize, Organize, Involve, Communicate, Educate, Serve.

This attack smells to me like an organized campaign designed by professional PR people who might be employed by a law firm representing Shirley in a current or planned lawsuit against S-A. I asked Shirley:

“Don’t you think you are going too far? While you may have a legitimate issue with S-A, is flooding its FB page about DVT (VOICES) ethical on your part? I suppose you have a lawsuit against S-A brewing. If so, why don’t you reveal that in your posts? Let me know — I am blogging now!”

She responded almost immediately: “Hi John, no lawsuit that we know of. They refuse to answer my registered posted letter and emails so…………”

Probably the papers have not yet been served, therefore no “lawsuit”!

Where’s the Terms of Use Policy?
In any case, S-A has made a faux pas and has NOT taken its own advice about posting a Terms of Use policy on its VOICES Facebook page. In comments to the FDA, S-A stated that

“It is advisable for company sites to include clearly-stated Terms of Use … For unbranded (non-promotional) sites, such as those devoted to disease awareness, sanofi-aventis recommends the following Term of use:

‘This site is not intended as a forum for discussing specific products or other treatments. It’s best to talk to your doctor about specific treatments. You may want to contact our Medical Information Department for product specific questions at 1-800-xxx-xxxx.’”

I searched the VOICES FB page and could not find any Terms of Use statement.

Where is S-A’s Social Media VOICE?
S-A sure is getting a lesson on how to handle social media communications! What it needs to do quickly is to get vitalized, organize its response, involve its legal and PR people, communicate with Shirley, and educate themselves about social media so that they better serve their FB community!

P.S. I was just informed that all the posts I mentioned are now gone from the VOICES FB page. It appears that the person responsible for this page just got into work (its 9:14 AM) and saw the mess and quickly got to work cleaning it up (still no Terms of Use though).

In case you think I made all this up, I took a screen shot of the top few posts this morning. Here it is:

Maybe the responsible S-A person was out sick yesterday?

As I mentioned above, you can find all the posts here.

Read more from the original source
Patient "Unadvocate" Lays Siege to sanofi-aventis VOICES Facebook Page. Where’s S-A’s Social Media VOICE?

Thinking about patients first here are some things that should be standard when it comes to Internet & Social Media marketing for drug and medical device companies:

1. Drug & medical device companies can not be expected to monitor and respond to all social media posts by consumers. There are way too many websites where consumers can post their opinions and although social media is used as part of health information searches most consumers do NOT rely on the information for their decisions. (100% that is)

2. Credibility of information is important but adding an FDA logo to website searches or for content on websites would not necessarily mean a lot when people don’t trust the FDA. When drug companies first started to use the Internet as a marketing tool there were some companies who were willing to rate content credibility. The problem is that these companies did not spend the marketing dollars necessary to inform and win over a skeptical public. Drug companies websites should be urged to use third party content from institutions like Harvard Medical School or the Mayo Clinic whenever possible provided the content is credible. Why drug companies don’t ask their thought leaders (physicians) to write more content for websites is beyond me they are a great resource for patients.

3. One click to fair balance should apply: Does the FDA really believe that someone is going to read a drug name on a search engine and make a healthcare decision based on that information ? Why do warnings have to be in search results ? The reality is that people, if interested, WILL click on the link and thus get the fair balance information. News to the FDA: drug side effects and warning pages within websites are often the most viewed pages.

4. Drug companies should be required to register customers of their products. When we purchase software or even a coffee maker we are asked to register the product for updates. Why can’t the drug companies do the same thing so that they can keep patients informed on product updates (new indications, new warnings). It also gives the drug companies a great tool to listen to their customers and use them as an online panel for new marketing programs not to mention the CRM possibilities.

5. Google needs better enforcement of bogus websites: Google is trying to get into ehealth in a big way. Why they don’t have a search engine devoted to just health is beyond me but than maybe the people at Google spend too much time in their playrooms. The goal of health specific search engine would be to break down searched by credible health information, treatments and then products. There are way too many illegal pharmacies that still show up on Google searches not to mention the quacks who promise that supplements can cure our ills without the need for prescription drugs.

6. Use of social media for marketing of drugs: The same guidelines that apply to web marketing should apply to the use of social media. Social media should be allowed as long as posts can be filtered and the company has process to report adverse events should a customer report one. I would discourage the use of Twitter as a marketing tool because drug companies run the risk of having patients ask for medical advice and it requires 24/7 monitoring.

Finally if I were the FDA I would ask the people from Manhattan Research to come to Washington D.C. and begin a new research program to learn how the FDA and healthcare industry could both meet patient need when it comes to online health information. This research should be funded by the FDA and made available to everyone when completed quarterly. This would give patient a huge voice in decisions that directly effect the way they search for health information.

It’s amazing that PhRMA would come up with recommended guidelines that seem to be developed over a cup of coffee rather than really think about how consumers use and need health information online. The people at PhRMA need to contact the sales people at Manhattan Research to get updated information before they pull ideas out of space.

Thinking about patients first here are some things that should be standard when it comes to Internet & Social Media marketing for drug and medical device companies:

1. Drug & medical device companies can not be expected to monitor and respond to all social media posts by consumers. There are way too many websites where consumers can post their opinions and although social media is used as part of health information searches most consumers do NOT rely on the information for their decisions. (100% that is)

2. Credibility of information is important but adding an FDA logo to website searches or for content on websites would not necessarily mean a lot when people don’t trust the FDA. When drug companies first started to use the Internet as a marketing tool there were some companies who were willing to rate content credibility. The problem is that these companies did not spend the marketing dollars necessary to inform and win over a skeptical public. Drug companies websites should be urged to use third party content from institutions like Harvard Medical School or the Mayo Clinic whenever possible provided the content is credible. Why drug companies don’t ask their thought leaders (physicians) to write more content for websites is beyond me they are a great resource for patients.

3. One click to fair balance should apply: Does the FDA really believe that someone is going to read a drug name on a search engine and make a healthcare decision based on that information ? Why do warnings have to be in search results ? The reality is that people, if interested, WILL click on the link and thus get the fair balance information. News to the FDA: drug side effects and warning pages within websites are often the most viewed pages.

4. Drug companies should be required to register customers of their products. When we purchase software or even a coffee maker we are asked to register the product for updates. Why can’t the drug companies do the same thing so that they can keep patients informed on product updates (new indications, new warnings). It also gives the drug companies a great tool to listen to their customers and use them as an online panel for new marketing programs not to mention the CRM possibilities.

5. Google needs better enforcement of bogus websites: Google is trying to get into ehealth in a big way. Why they don’t have a search engine devoted to just health is beyond me but than maybe the people at Google spend too much time in their playrooms. The goal of health specific search engine would be to break down searched by credible health information, treatments and then products. There are way too many illegal pharmacies that still show up on Google searches not to mention the quacks who promise that supplements can cure our ills without the need for prescription drugs.

6. Use of social media for marketing of drugs: The same guidelines that apply to web marketing should apply to the use of social media. Social media should be allowed as long as posts can be filtered and the company has process to report adverse events should a customer report one. I would discourage the use of Twitter as a marketing tool because drug companies run the risk of having patients ask for medical advice and it requires 24/7 monitoring.

Finally if I were the FDA I would ask the people from Manhattan Research to come to Washington D.C. and begin a new research program to learn how the FDA and healthcare industry could both meet patient need when it comes to online health information. This research should be funded by the FDA and made available to everyone when completed quarterly. This would give patient a huge voice in decisions that directly effect the way they search for health information.

That’s not a money-making proposition, in case anyone thinks I’m advocating it. There are just too many surprises. But Intermune’s good fortune started last week, when the FDA briefing documents came out on the application on the company’s pirfenidone for idiopathic pulmonary fibrosis and were characterized as “not as bad as they could have been”. (The company’s history of overzealous PR wasn’t helping it at this point). And if you still don’t think that the moves in the stock have been surprising, consider that two ITMN executives sold shares on after the first jump, missing out on the second one completely when the FDA advisory panel gave the drug a favorable recommendation.

Pirfenidone, by the way, is another structure entry in the so-simple-I-can’t-believe-it drug sweepstakes. If approved, it would be the first specific therapy for IPF, which can be a nasty disease. I certainly hope it helps out the patients involved (a few hundred thousand in the US), but that small patient population means that the drug isn’t going to be cheap. Intermune’s investors certainly don’t think so.

But as has been clear for some time, we’re in a rather tricky environment for expensive health care options. If pirfenidone makes it, I’d guess that it will be picked up widely, but cautiously, by health insurance. No one knows how it’ll perform in the real world, and if little benefit is seen, it’ll be hard to justify reimbursing for it. (It made one Phase III trial’s endpoint, but missed another one, so there’s room to wonder). The more cost-conscious European regulatory agencies will be a good place to watch this argument play out. One correspondent of mine refers to the drug as the next Iressa. That’s not a compliment.

While a massive amount of work has been done to find common genetic triggers to diseases like cancer and diabetes, some scientists believe that individual cases are typically spurred by rare rather than common mutations. And now that sequencing costs have fallen to about $50,000 or less, scientists have begun to explore what they can learn about the genetic

While a massive amount of work has been done to find common genetic triggers to diseases like cancer and diabetes, some scientists believe that individual cases are typically spurred by rare rather than common mutations. And now that sequencing costs have fallen to about $50,000 or less, scientists have begun to explore what they can learn about the genetic

This is needed and should be accepted practice. There is no way that ANY drug company can control ALL user comments via any media. Remember the Internet is about users not marketers.

Among the most self-serving, egotistical recommendations is the recommendation from Edelman that companies should have responsibility for user-generated content on their own sites. Of course this would allow Edelman and others to sell pharma on their social media monitoring services. Garbage pure and simple

PhRMA wants the FDA to adapt a universal symbol for some media like Twitter and Facebook but again does PhRMA really believe that is going to help in an era when consumers don’t trust the drug industry or the FDA? The answer to that is NO and it clearly shows that the drug industry is clueless when it comes to understanding HOW people are using online health information. The FDA and the drug industry have a long road to travel to reestablish trust with a skeptical public.

Proposed Universal symbol: Does this really matter to consumers ?

(click to enlarge)

Lost in all these recommendations are consumers and patients. They are the ones who are defining how health information is used and what health information is the best source of information. I would also like to have seen some recommendations from from some physician groups like the AMA. Physicians are being forced to digitize their practices and they should have input about how their patients receive and use online medical information.

Proposed information on search

And who is going to test this with consumers ?

The drug industry spends a lot of time and money testing everything from images to messages. You would think that since the Internet is now the most important channel for health information someone who say “we need to study this with consumers” before submitting recommendations that don’t mean a lot with a skeptical public.

J&J asked that companies not be held responsible for user comments they do not control.
This is needed and should be accepted practice. There is no way that ANY drug company can control ALL user comments via any media. Remember the Internet is about users not marketers.

Among the most self-serving, egotistical recommendations is the recommendation from Edelman that companies should have responsibility for user-generated content on their own sites. Of course this would allow Edelman and others to sell pharma on their social media monitoring services. Garbage pure and simple

PhRMA wants the FDA to adapt a universal symbol for some media like Twitter and Facebook but again does PhRMA really believe that is going to help in an era when consumers don’t trust the drug industry or the FDA? The answer to that is NO and it clearly shows that the drug industry is clueless when it comes to understanding HOW people are using online health information. The FDA and the drug industry have a long road to travel to reestablish trust with a skeptical public.

Proposed Universal symbol: Does this really matter to consumers ?

Lost in all these recommendations are consumers and patients. They are the ones who are defining how health information is used and what health information is the best source of information. I would also like to have seen some recommendations from from some physician groups like the AMA. Physicians are being forced to digitize their practices and they should have input about how their patients receive and use online medical information

Proposed information on search

And who is going to test this with consumers ?

The drug industry spends a lot of time and money testing everything from images to messages. You would think that since the Internet is now the most important channel for health information someone who say “we need to study this with consumers” before submitting recommendations that don’t mean a lot with a skeptical public.

I agree with Jim Edwards of BNET that although this particular case involves the DPT vaccine, the vaccines-cause-autism crowd will be watching this one very closely. Lawsuits will no doubt be ready to fly later this year in case the Supreme Court breaks that way – which seems to me unlikely, but I’m no judge. . .

“If you are a man diagnosed with diabetes or high blood pressure and I tell you that you need to lose weight and take medication, and I can say the benefit is five extra years of sex life, you might be more inclined to do what I tell you,” the author of a study on sex and health recently stated. The problem is that very few physicians have the time to have this talk with their patients and it’s too easy to just treat the condition rather than the patient.

Having trouble with intimacy ? No problem just take Viagra as opposed to getting some exercise, watching what you eat and moving around instead of being a couch potato. Have people become more used to counteracting bad health decisions because they can take a medication for it? More studies are probably needed but I believe it’s safe to say that a lot of people could control their high blood pressure and cholesterol with modifications to their diets and lifestyles.

The FDA is in the process of a major overhaul of their guidelines for the marketing of prescription drugs and maybe it’s time they required drug companies to band together and devote a certain percentage of their DTC marketing dollars to education and prevention. I’m not talking about individual efforts, rather a one stop online website dedicated to how to get healthier when you have high blood pressure, consumer education on the dangers of sodium in your diet, and the fact that every extra pound we carry results in a shorter life span. Sure I know it’s hard but an integrated effort with insurers, companies (via their company intranets) and health portals has to be taken with physicians and other health care professionals as advisory board members. We can’t just say “it’s too hard”, we have to make an attempt to try and change consumer health styles before it’s too late.

> Human Genome Sciences has named David Southwell as CFO and EVP. Release

> Robert Shepard has been appointed CMO of Cornerstone Pharmaceuticals. Release

> Shengtai Pharmaceutical has appointed Hu Ye as its new CFO. Release

> Talaris Advisors has named Derek Lee as CFO and corporate development officer.

Cultivating relationships with both physicians and patients is a critical part of the marketing process for pharma as you need HCPs to prescribe drugs and patients to stay compliant on them. So, making an investment in those relationships, including how they are tracked and measured is key.

Conceptually, this is nothing new. Pharma has always used data to identify and reach out to high decile physicians and analyzed market data to uncover the best vehicles and target audience for their DTC messages. But with the saturation of healthcare information, physicians and patients online, and the fragmented media landscape through which to reach them, greater care needs to be taken in capturing and and analyzing data geared toward maintaining ongoing relationships rather than just a singular script.

At The Encima Group, we say that “you can’t manage effectively what you don’t measure accurately,” and this applies not to just campaigns, but relationships. There are four key relationships that you need to keep in mind along the marketing continuum:

1. Pharma Co / Physician Relationship: This relationship is obviously nurtured mainly via the sales function, but the web has created new channels through which to reach — and maintain — ongoing relationships with physicians. From providing online tools and resources to creating two-way interactions on physician portals and your own company website, you can cultivate this important relationship.

2. Physician / Drug Data Relationship: In order for a physician to prescribe optimal drugs or therapies for patients, they need to have a comfort level with the data provided by the pharma company in relation to relative risk, fair comparisons etc. By providing them with comprehensive data and developing gateways through which they can access and query that information against their needs, they will have your drug top of mind and the data needed to make the best treatment decisions. You’ll also have the data you need to strengthen that relationship.

3. Pharma Co / Patient Relationship: This relationship is important for two reasons — a) stimulating brand name drug requests and b) ensuring patients stay persistent and compliant with their therapies. By fostering a relationship with patients, you create health ambassadors invested in their own wellness — and your brand.

4. Physician / Patient Relationship: Ultimately, a patient’s relationship with their healthcare professional will always be the strongest and have the greatest impact on their treatment plan and decision. So, facilitating the physician-patient relationship is critical to close the loop on the process and ensure that your brand is the benefactor of positive outcomes.

Now that we’ve identified the key relationships to manage, you need to align them with objectives and data points for assessing and meeting those goals. A good trick to is plan with the end in mind. If your goal is to increase physician prescribing, for example, assess what data would be instrumental in ensuring that end result such as past prescribing behavior, patient conditions in the practice, proclivity to your brand, number of interactions etc. Some of that data can be gathered via third party services such as IMS but others can be gleaned through efforts you put into place such as physician surveys, email campaign response, online activities et al. Every interaction a physician or patient has with your company is a data point and can give you key insight into brand affinity or obstacles you need to combat so that you can put the necessary actions into place to meet your objectives. But you must start thinking along these lines to create cohesive programs that go beyond just advertising to stimulate engagement. Engagement leads to awareness, awareness leads to consumption and consumption leads to action. And that engagement is quantifiable at every single touch point.

As opposed to the two guys who scavenged a liquid oxygen Dewar from a scrap metal yard and decided to put it back into service. According to the most detailed report, they tried to rig up a connection to refill the cylinder, but found that it vented immediately through the pressure-relief valve. So. . .well, yeah, you know what’s coming next: they took the darn thing off and plugged it shut. No more pesky venting! They filled up their cylinder, which was loaded on the back of their pickup truck, and went rolling down the interstate at lunchtime. Whereupon they had a flat tire, and pulled over for a while to fix things. . .

OK, you can look out from behind your hands now. Although I can’t imagine how, neither of these two cowboys managed to get themselves killed, nor did they take out anyone else, through what appears to be sheer blind luck. According to the report, one member of the Cylinder Kings ended up being blown across five lanes of traffic, while his partner was launched forty feet in another direction. You can see from the photo how the truck weathered things. I can’t imagine that a pressure wave of straight oxygen hitting tank of gasoline can end well; it’s a perfectly reasonable mixture to put a payload into low-earth orbit.

Which is a good note on which to take inventory here. We have the owners of the oxygen cylinder accounted for, and their truck. What about the cylinder itself? Well, similar to the nitrogen tank referenced above, it had failed at the bottom weld and thus departed the scene of the accident like an artillery shell. It re-entered the affairs of the world a quarter of a mile away, plunging through the roof of an apartment, completely trashing the place (and severing a natural gas line in the process). As I said, how a dozen people didn’t end up killed by all this is a complete mystery to me. (The red circle in that photo is where the pressure-relief device used to be. )

So the moral of this story is, I suppose, that Pressure Relief Devices Are There For A Reason. Or maybe it’s “don’t scrounge gas cylinders from the scrap yard and try to get them to work”. Or perhaps “just because you haven’t seen a pressure vessel explode yet, it doesn’t mean that they can’t”. Or “Gegen der Dummheit kämpfen Götter selbst vergebens.” Or something.

I am having some problems with the numbers when I compare them to previous reports. For example, the total ad spend in 2009 was reported to be $4.51 Bn. If that is a 1.9% increase over 2008, then ad spending in 2008 must have been $4.42 Bn. But data reported previously by Nielson (see here) says pharma ad spending in 2008 was $4.34 Bn. My notes, however, indicate that the latter was an estimate based on spending for the first 9 months of 2008. So let’s forget the latter total and use the former (I adjusted it to $4.425 based on a 1.9% year-over-year increase, which corresponds to Nielsen’s latest data; see here).

Working backwards from the year-over-year percent increases reported by Nielsen, I get the following table comparing 2009 to 2008:

All the % Inc/Dec numbers agree with the Nielsen data as reported by AP here. However, the Outdoor spending number for 2008 is suspect. I had to use that number to make sure the total for 2008 more or less agreed with the total based on a 1.9% year-over-year increase. Believe me there are other numbers out there that add up even worse, such as this table I found on World of DTC Marketing:

The totals in this table aren’t even close to what was reported in the AP article (Nielsen data). Actually, these are numbers for the first 9 months of each year. But TNS Media Intel’s 2009 Internet number of $220.9 million is much larger than Nielsen’s 2009 number of $117.4 million. How can these be so different? I’m pretty sure both are reported “measured” media, which does not include search engine ads. TNS/Kantar Media Intelligence told me that it tracks over 3,000 sites throughout the US and Canada, which is a different methodology than that used by Nielsen. So it’s important not to compare these apples and oranges! Note: TNS/Kantar Media reports that outdoor pharma ad spending for 2008 was $3,084 million.

In any case, here’s what the media mix looks like, 2009 vs. 2008 (using Nielsen data):

Read the original here
Making Sense Out Pharma DTC Spending Trends