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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« Avandia: Trouble or Not? | Main | Knowing What You Know. . . »

May 25, 2007

More Avandia, And More on Marketing

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Posted by Derek

Insider, author of the Pharmagossip site, sent along this link to an article on Avandia at the Health Care Renewal site, flagged as "essential reading". After looking it over, I don't think I agree, and I thought it might be worthwhile to explain why.

The HCR piece quotes extensively from this New York Times article, headlined "Years Ago, Agency Was Warned of a Drug's Risks". Its focus is a letter that Dr. John Buse of UNC (now president-elect of the American Diabetes Association) sent to the FDA in 2000 on the possible cardiovascular risks of Avandia. Reading HCR's summary is a somewhat different experience than reading the original article, though - for one thing, you miss out on the part about how even now Dr. Buse isn't calling for Avandia to be be taken off the market. Rather than finding the Nissen New England Journal of Medicine paper to be the smoking gun he's been waiting for, he advocates waiting for the GSK cardiovascular risk study to be completed before making any decisions.

The HCR article has some good points in it, but to my ear they're phrased oddly. For example, it advocates a skeptical attitude toward the marketing claims made by drug companies, which is very good advice. But that's very good advice for evaluating the marketing claims of companies in every other industry, too. They're trying to sell you something. They will present their product in the most favorable light possible, whether that product is a car, a diabetes drug, or a burrito.

And that's the part that drives some people crazy, because it seems wrong to have potential life-saving drugs handled the same way as pickup trucks and enchiladas. They're not, though: the reason we can argue about drug company marketing is that drugs already have something that almost no other product has, which is a body of statistically valid comparison data. No data exist as to the long-term advantages and disadvantages of consuming a given brand of burrito versus its competition or versus an alternative meal. Cars are somewhat more data-rich, thanks to government and insurance company testing, and frequency-of-repair databases like those kept by Consumer Reports. But that's about the highest standard for comparison data outside of the drug industry, and you'll look in vain for P values and other tests of statistical significance, because there aren't any. In short, marketing claims in virtually every other industry can go relatively unchallenged, because there's little to measure them against.

So, that's why one of the things that I dislike about the Health Care Renewal piece is the hand-rubbing now-we've-got-'em tone that I detect in it. You don't have to go far to find it from plenty of other sources, either, which is why people like me are perhaps too touchy on the subject.

Comments (26) + TrackBacks (0) | Category: Cardiovascular Disease | Diabetes and Obesity | Press Coverage | Why Everyone Loves Us


COMMENTS

1. SNP on May 25, 2007 9:21 AM writes...

Also, it's not clear to me that there's a meaningful storyline behind all the insinuation. The FDA and Glaxo were "warned" several times years ago and now Nissen aggregates data that have accumulated since then and came up with what's at best sketchy, not-quite-significant evidence of a problem. Was there any point where either the company or the regulators had both "warnings" and actual evidence?

On the other hand, there is an element of live by the odds ratio, die by the odds ratio here. It's true that even a significant increase in the odds ratio in this case is relatively unimportant in a number-needed presentation, but companies are happy to obscure that distinction when it comes to efficacy.

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2. Deepak on May 25, 2007 9:21 AM writes...

It's one reason I stopped reading HCR. In the end, it wasn't objective enough and I always detected an agenda

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3. Roy M. Poses MD on May 25, 2007 10:07 AM writes...

Our agenda is to make health care more honest, and more focused on the patient.

The issue is not whether Avandia should be off the market. The issue is what are its benefits and harms, how probable are they for individual patients, and for which patients should it be used.

If relevant data about this are withheld, or available only in obscure places, patients and physicians will end up making decisions based on incomplete data, and this will lead to bad decisions, and ultimately to less than optimal patient outcomes, to put it politely.

The reason the Nissen article was big news was that it provided a look at data that was not available until recently, and was made available in a relatively obscure place (the GSK web-site, not the New England Journal). There were studies Nissen included in his meta-analysis from 9 years ago which were never published, and hence whose results were unknown until they appeared on that web-site. And I believe the data on the GSK web-site were only there because of a settlement GSK made in a law-suit.

I am for a skeptical attitude towards all marketing. But making health care decisions is much harder, more complex, more uncertain, more stressful, and more high stakes than buying a burrito, or a car.

Maybe that's why there is a need for better data about health care products than about automobiles. And that's why the consequences of suppressing data about clinical trials may be more serious than, say, suppressing data about consumer satisfaction with their cars. Moreover, as I've noted before, suppressing data from clinical research breaks the promises made to patients who participated in the trials who thought they were being experimented upon to advance science and health care.

Finally, as a physician, it bothers me every time someone starts talking about "life-saving" drugs. There are a few drugs that are life-saving in a few circumstances. I wish there were more. But most aren't. There is absolutely no evidence that any glucose lowering drug is "life-saving" for patients with type 2 diabetes, for example.

So, yes, we want the pharmaceutical and biotechnology industries to have incentives to develop beneficial and even life-saving drugs.

But thinking that any skepticism about these industries' actions, or the data supporting use of their products, will scare them off from producing life-saving drugs just doesn't make sense.

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4. Kevin Fleming on May 25, 2007 10:28 AM writes...

There was similar glee about the demise of Cox 2 inhibitors. However, their absence have left some people in pain that cannot be treated, people who would have been glad to take a future risk uncertain about heart attacks if only they could forego pain now.

But too bad for them.

Too bad for diabetes patients as well. Not every long term side effect is a scandal. Such an approach suggests a belief in Snidely Whiplash CEOs cackling greedily while their patients die. I find the claim rings false. We can always destroy drug companies by suing them away.

But try building a new one after that.

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5. S Silverstein on May 25, 2007 10:54 AM writes...

So, that's why one of the things that I dislike about the Health Care Renewal piece is the hand-rubbing now-we've-got-'em tone

Dreek, I think the tone you're detecting has to do with the Hippocratic Oath rather than with a desire to "get 'em."

As an informatics-issue writer for HCRENEWAL, I am one of the strongest proponents of new drug development, but as my mentor, heart surgeon Victor P. Satinsky said, "critical thinking always - or your patient's dead."

Please let me state that one major problem in pharma is that they don't know how to handle negative PR well - the MSM indeed often takes an unfair attitude - but pharma has damaged their credibility further as a result of heavy-handed measures (such as trying to make new, societal-scale-untested vaccines mandatory, in a recent example).

Pharma also has other deficiencies regarding issues such as information management besides. These deficiencies have helped put competent medicinal chemists and other scientists out of jobs.

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6. Wally R. Smith, MD on May 25, 2007 11:15 AM writes...

I seldomly blog on Health Care Renewal or any place. But I felt compelled to enter this comment.

I agree that it is good that we as a society have required drugs, perhaps more than any other product we consume, to have strong data for their safety and efficacy. It is good that this data is made public and reviewed by peers before we are allowed to consume the drug.

But one of the things we are learning about the approval environment is that it is flawed, not transparent, and subject to undue influence from stakeholders. Further, sometimes things are purposely twisted in the evidence-production, evidence-dissemination, or evidence-evaluation process of a drug, without us knowing it. I have coined the term "pseudoevidence," in a January 2007 article in Clincal Governance: an International Journal, for the falsehoods that may be taken as truth as a result of any of the above. And why? The fox is guarding the chicken coop. Those interested in selling the drug usually pay for and conduct the research. The research is published in journals often financed, through ads or other means, by the companies. The results may be twisted, or only partially revealed, by the companies, "putting their best foot forward."

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7. Palo on May 25, 2007 11:49 AM writes...

Avandia, cars and burritos, apples and oranges. By definition new drug has a new component never tested before, a component that, by definition, changes your biological functions. New car and new burritos typically are new designs of known parts that might alter our driving and tasting experiences but do not in principle alter our biology (obviously a car crash changes our biology, and that's why crash-tests are done carefully). Information on potential risks of the new drug are infinitely more relevant than information on the thickness of the tortilla that makes a burrito into a new chalupa.

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8. beenthere on May 25, 2007 11:57 AM writes...

Silverstein,

I would like to endorse your appeal to Hippocrates on this particular blog and in this particular era. I sincerely hope that there are more physicians like you who adhere to Hippocrates' point-of-view and his attendant ethics. Forgive me for sounding cynical however my experience leads me to believe that, in this regard, only a minority within our profession would make such an appeal. I have come to the conclusion that (words, essays and graduation addresses notwithstanding) Hippocrates is no longer in vogue; his ethics are no longer practiced. I submit the current and growing popularity of abortion and euthanasia within the medical profession as the data upon which this conclusion is based. Sadly, it is my humble opinion that utilitarianism has made a significant come-back in the minds of most physicians.

I know all too well the frustration good men like you experience in trying to do the right thing while our profession is, in the words of Prof. Bjork, 'Slouching Towards Gomorrah'. Best of luck to you Quixote & Kind Regards.

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9. Maggie Mahar on May 25, 2007 12:04 PM writes...

Derek writes:
" But that's very good advice for evaluating the marketing claims of companies in every other industry, too. They're trying to sell you something. They will present their product in the most favorable light possible, whether that product is a car, a diabetes drug, or a burrito."

The difference between health care and other industries is that health care is an industry where "caveat emptor" should NOT apply for two reasons.

First, if the product is less than advertised, the consumer could be hurt-- or even die.

Secondly when it comes to health care products the "consumer" is a patient. He is sick; he may be in pain; he may well be frightened; and he may be desperate. All of this means that he is more vulnerable to deceptive advertising than the consumer who is purchasing a burrito.

Derek goes on to suggest that we have lots of information that helps us compare drugs:
". . .drugs already have something that almost no other product has, which is a body of statistically valid comparison data."

The fact is that most drugs that are approved by the FDA have not been compared to the best alternative already available on the market. Drug
makers object to such "head-to-head" comparisons and prefer to have their newest products compared to placebos. As a result, it is very difficult to judge whether the new product is significantly better than the older product-- which has a longer track record, and is almost always cheaper.

Secondly,drugs often come to market without long-term data, so we don't find out about the risks until large numbers of patients have been exposed to those risks.

Vioxx serves as a good example. Regarding Vioxx and other Cox 2 inhibitors, Kevin writes: "There was similar glee about the demise of Cox 2 inhibitors. However, their absence have left some people in pain that cannot be treated, people who would have been glad to take a future risk uncertain about heart attacks if only they could forego pain now.
But too bad for them."

It's true that Vioxx would have been a good drug for a small group of people who could not tolerate the older painkillers. But rather than marketing Vioxx to that group, Merck purposefully marketed it to the largest possible audience, advertising Vioxx as the painkiller that everyone should take.

As a result, a great many people were exposed to the risks. Some died and Merck's lawyers insisted that Merck withdraw Vioxx from the market.

Thus, Vioxx went from being a drug that 'everyone should take" to being a drug that "no one can take." By virtue of its irresponsible marketing, Merck itself was responsible for making Vioxx unavailable to people who could benefit from it.

It was Merck, not HCRenewal that said "too bad for them."

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10. Kevin Fleming on May 25, 2007 12:50 PM writes...

Re: "that's why crash-tests are done carefully" and "information on the thickness of the tortilla"

Folks used to accept far more risk in the past than they are currently willing. Automobile crash test dummies didn't come into common use until the 1960s, more than a half-century after cars were first available. And despite remarkale safety advances, you are still far more likely to die from a car accident than an Avandia-induced MI. But I don't the suspect GM or Toyota of laughing maniacally about profit about their undiscovered scheme to cheat the consumer.

As for chalupas, have we so soon forgotten the spate of Taco Bell-induced illnesses?

Unfortunately, medical products aren't inherently different than other products just because they have a health care application. Greater scrutiny is required, to be sure, but it does no one any good to assume that Pharma firms are just modern robber barons (especially as the latter can be shown never to have existed).

HC Renewal performs a valuable service in scrutinizing Pharma practices. But the goal should be a better product, and demonizing should be avoided.

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11. Still Scared of Dinosaurs on May 25, 2007 2:46 PM writes...

My knowledge of the Hippocratic* Oath begins and ends with, "First, do no harm" and I wouldn't be surprised if even that is tainted by the misquotation or misinterpretation that attaches to the popular understandings of such sayings. As stated here, though, it's a pretty stupid restriction on doctors, but I guess that "First, do everything in your power to provide the best balance between the likelihood of benefit and the risks of harm" just doesn't have the same zing. It's the world I live in, though.
*Do neoCons call it the "Hippocrat" Oath?

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12. Hap on May 25, 2007 5:21 PM writes...

The benefits of having a car are clear to me (and to most people, I suspect), as are the costs, both financial and otherwise. Neither the costs of drugs (in terms of their side effects, interactions with other drugs, etc. - their financial costs are readily available) or their effective benefits (in terms of operating variables - lifespan, incidence of sickness, etc.) are readily apparent to anyone not substantially skilled in the area, and in some cases, they may not even be known to those people. The ability of purchasers or (either insurance companies or patients) or of doctors to know what the costs and benefits of a drug are is limited.

Advertising, by its nature, doesn't reflect this - it is designed to avoid hints that the consequences of purchasing a product may not be good, while trying to avoid the legal consequences of that implicit assertion with data that is difficult for all but practitioners in the field to understand. This seems more than a little dishonest - even with brokerage firms, where the advertising is attempting to sell something that it cannot actually promise to deliver, the uncertainty is made explicit (if desperately soft-pedaled).

People are unwilling to involuntarily accept even small risks for someone else's benefit (pollution for example). People are also less likely to accept risks that they did not know about (and could not know about) ahead of time - for example, people who found out that their insurance companies didn't actually restore their cars to original condition as they had promised. Finally, people expect more from expensive things than from cheap things - they are rarely willing to pay high costs for risky things unless the alternative to not doing so is a lot worse. I have a difficult time seeing any of these types of risk-aversity as being ridiculous, particularly when the benefits for which these risks are being incurred are uncertain and difficult to understand when known.

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13. S Silverstein on May 25, 2007 6:08 PM writes...

re: #11 Still Scared of Dinosaurs,

I think neocons still call it the Hippocratic Oath as they Try And Take Over the World! I believe liberals and conservatives do, too.

All jokes aside, here is the modern version as a reminder.

Hippocratic Oath—Modern Version

I swear to fulfill, to the best of my ability and judgment, this covenant:

I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.

I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin traps of overtreatment and therapeutic nihilism.

I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon's knife or the chemist's drug.

I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the skills of another are needed for a patient's recovery.

I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God.

I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person's family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.

I will prevent disease whenever I can, for prevention is preferable to cure.

I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.

If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.


Written in 1964 by Louis Lasagna, Academic Dean of the School of Medicine at Tufts University, and used in many medical schools today.

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14. no_point on May 25, 2007 10:17 PM writes...

I really do think that most of us working in the pharmaceutical/biotech industry have the patient in mind when we go to work everyday.

But, advertising to sell drugs is different from advertising to sell cars and burritos (does anyone see the irony here). I have tried to make this distinction on this board before but I think I lack the art of making eloquent arguments.

It appears that sometime the year end bonus handed out to most big pharma emplyees may have something to do with their perceptions about drugs, cars and burritos. Its all the same - people die in car accidents and after choking on burritos - so why not kill them with our drugs!

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15. Insider on May 26, 2007 3:00 AM writes...

Who said these words about the Pargluva debacle:

"What on Earth were they thinking, submitting data in a way that makes it look like they were trying to pull a fast one with the cardiovascular risk factors? Now, of all times? Who knows, maybe people at BMS had just convinced themselves that things were fine, somehow - the capacity for human self-deception is limitless. But didn't anyone at Merck turn pale and have to sit down when they saw these numbers?"

It was you, Derek.

In another excellent post.

http://www.corante.com/pipeline/archives/2005/10/20/this_had_better_be_good.php

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16. Morten on May 26, 2007 6:29 AM writes...

I sincerely believe that it would be better for both pharmas and patients if marketing of drugs directly to patients were banned in the US as it is in much of the rest of the world.
"But if it's better for the pharmas why don't they just stop it?"
Well that would be unethical. If Pharma A competes with Pharma B and A decides to stop all marketing its sales would decrease. Investors would get a smaller return on their investment and employees might be without a job. Pharma A hasn't upheld its social contract with the investor to give the best possible return and with the employees to give job security (not to mention that if the products aren't completely identical some patients that should have been treated with A's get B's instead).
If patient marketing was banned it would be an equal disadvantage to A and B, and I believe it would be better for both society and the companies in question.

Strictly utilitarian ethics btw ;)

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17. Anonymous on May 26, 2007 8:54 AM writes...

>> Those interested in selling the drug usually pay for and conduct the research.
>> The fact is that most drugs that are approved by the FDA have not been compared to the best alternative already available on the market.
Well, the mandate is evidence of safety and efficacy, not superiority. If you want fair comparisons between marketed therapies it would be best to have disinterested parties run and analyze them. Unfortunately, these disinterested parties always want someone else to pay for them and frequently aren't very good at running them.

>> S Silverstein
Thanks for the updated Oath, I like it a lot better, not that my opinion counts for much. And does anyone else get a chuckle out of the image of a bunch of the best and brightest ending an 8-year, $500,000 educational process by holding up their right hands and saying, "I, state you name..."
No disrepect to Hippocrates intended, BTW.

>> no_point
>> I have tried to make this distinction on this board before but I think I lack the art of making eloquent arguments.
Ummmm, no disrespect to you either but maybe your handle is cutting into your credibility a little. :)

>> Pharma A hasn't upheld its social contract with...the employees to give job security
Ask Derek about the fine print in THAT contract.

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18. Still Scared of Dinosaurs on May 26, 2007 8:57 AM writes...

Ooops, that was me.

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19. Kirsten on May 26, 2007 11:14 AM writes...

I haven't seen any discussion about the implications for other P-PARs. Bextra and Celebrex came under intense scrutiny after Vioxx was withdrawn. I wonder if the same will happen with drugs like Actos?

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20. S Silverstein on May 26, 2007 7:24 PM writes...

#16 anonymous,

And does anyone else get a chuckle out of the image of a bunch of the best and brightest ending an 8-year, $500,000 educational process by holding up their right hands and saying, "I, state you name..."

Perhaps you are being too pessimistic.

There are many clinicians for whom integrity and honor are extremely important. I've encountered many during my years of medical practice.

I worry more about the effects of moral relativity taught in k-12 and on TV. Once that sets in, the 007 doc** phenomenon is not far behind.

** like James Bond, licensed to kill

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21. Morten on May 27, 2007 12:26 PM writes...

Still Scared of Dinosaurs: Yes it sucks that Derek got fired but personally I would rather work for a company that fires me if they have too, than one that tanks. There's no shame in being downsized imho. Maybe I'm just from a different generation.

Permalink to Comment

22. anon on May 28, 2007 7:16 AM writes...

Morten...

Derek, like myself, was laid off effective Jan 2007 due to a site closure. I have been working at GSK ever since, so who knows what my fate will end up being with the Avendia situation ongoing.

Regardless if the company "tanked" or people were laid off due to an adverse event of some sort (merger, problem with marketed drug, etc.), dealing with the uncertainty is still equally unpleasant.

The director of our group gave a farewell speech advising younger people to seriously consider a back up plan because more and more will be outsourced to China and India in the future. For what that is worth.

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23. George Laszlo on May 28, 2007 3:44 PM writes...

After all these comments, I'm beginning to wonder whether Derek's original point has gotten lost. Perhaps you, Derek, could comment on this.

To add to the arguments, we need to remember that only congress can legislate how the FDA behaves. So, for now, it is true that they are only allowed to evaluate safety and efficacy and not clear superiority.

If we want the FDA to make their decisions on clear superiority over existing treatments, then let's ask our elected representatives to do something about it. Keep in mind, however, that it's easy to legislate but not necessarily easy to execute. Exactly how do you determine superiority or greater safety? Would we not have to allow drugs to be on the market for extended periods before we could actually know that the safety or efficacy profile is better? Is there a catch-22 here?

Finally, let's not forget that biopharma firms are in business to make money. The fact that they are selling products that affect lives places extra burden on this industry. That should not automatically translate to the expectation that people working in the industry must be super-humans. Better educated, perhaps. With better moral and ethical grounding, perhaps? Without faults, no way.

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24. SNP on May 30, 2007 7:47 AM writes...

The WSJ had an interesting (subscription-only) piece on this yesterday. It's by a guy who clearly has an anti-regulation axe to grind, but still made a pretty convincing case that this is another case of the NEJM rushing something into press due to motivations well outside of a sober concern for scientific accuracy.

I'm all in favor of transparency, but it seems to me that researchers, journals and mass-media journalists have as much obligation to use disclosed data responsibly as the pharmas do to disclose them.

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25. Maggie Mahar on May 31, 2007 1:24 PM writes...

PM wrote "I really do think that most of us working in the pharmaceutical/biotech industry have the patient in mind when we go to work everyday."

My guess is that this is true of most if not all of the researchers and scientists.

The marketing department, on the other hand,
is not committed to pure science. It is committed to sales. When corporate marketers go to work every day they are thinking about shareholders (as they must. Legally, in the U.S. a corporation's first responsibility is not to its customers, but to its shareholders. It is not supposed to outright lie to its customers--but "caveat emptor" always applies. )

An example of the difference between scientists and marketers. I would guess that the research scientists who developed Vioxx were tryig to develop a pain-killer that would work for people who couldn't take existing pain-killers because they caused gastrointestinal bleedig. For that
relatively narrow band of patiets, Vioxx was an excellent drug--and scientists had good reason to be proud of it. (Even if everyoe was aware that Vioxx would increase the risk of stroke, for patiets in great pain who had no other alternative, the risk would in most cases be worth the benefit.)(

But then the marketig dept. got hold of Vioxx and decided to advertise it, on television, as "the best painkiller for EVERYONE." (This is a paraphrase, but there are documents from Merck's marketing dept. showing that they decided to roll it out as a big blockbuster drug and advertise it
as widely as possible.

No doubt some scientists at Merck who understood the purpose of the drug cringed.

As Jerry Avorn says in his book "Powerful Medicines" --we need to save pharmaceutical companies from their marketing departments.

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26. BOB FIDDAMAN on August 23, 2007 1:18 PM writes...

Okay, we all know who he is, we all know his stance on Seroxat 'I think patients have nothing to fear taking Seroxat' but did you know he is now defending the diabetes drug, Avandia?

Read more here:

http://fiddaman.blogspot.com/2007/08/is-alistair-benbow-deranged.html

Fid

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