As The FTC Goes After Bloggers, Doctors Making Millions Promoting Drugs With Little Oversight
from the feeling-healthy-yet? dept
Clay Shirky points us to a column from a few months back by Marcia Angell, which explains why clinical research on drugs isn't even remotely trustworthy, as it all-too-often seems to involve doctors who have serious conflicts:Or consider Dr. Alan F. Schatzberg, chair of Stanford's psychiatry department and president-elect of the American Psychiatric Association. Senator Grassley found that Schatzberg controlled more than $6 million worth of stock in Corcept Therapeutics, a company he cofounded that is testing mifepristone--the abortion drug otherwise known as RU-486--as a treatment for psychotic depression. At the same time, Schatzberg was the principal investigator on a National Institute of Mental Health grant that included research on mifepristone for this use and he was coauthor of three papers on the subject.Angell notes that this is pretty common:
Indeed, most doctors take money or gifts from drug companies in one way or another. Many are paid consultants, speakers at company-sponsored meetings, ghost-authors of papers written by drug companies or their agents, and ostensible "researchers" whose contribution often consists merely of putting their patients on a drug and transmitting some token information to the company.And as the relationship between doctors and pharma has gotten deeper and deeper, it means that the results of those all important "clinical trials" -- which the pharma supporters always insist are so important -- are highly suspect:
Because drug companies insist as a condition of providing funding that they be intimately involved in all aspects of the research they sponsor, they can easily introduce bias in order to make their drugs look better and safer than they are. Before the 1980s, they generally gave faculty investigators total responsibility for the conduct of the work, but now company employees or their agents often design the studies, perform the analysis, write the papers, and decide whether and in what form to publish the results. Sometimes the medical faculty who serve as investigators are little more than hired hands, supplying patients and collecting data according to instructions from the company.And yet the FTC is more worried about a mommy blogger recommending a book that a publisher sent her for free?
In view of this control and the conflicts of interest that permeate the enterprise, it is not surprising that industry-sponsored trials published in medical journals consistently favor sponsors' drugs--largely because negative results are not published, positive results are repeatedly published in slightly different forms, and a positive spin is put on even negative results. A review of seventy-four clinical trials of antidepressants, for example, found that thirty-seven of thirty-eight positive studies were published. But of the thirty-six negative studies, thirty-three were either not published or published in a form that conveyed a positive outcome. It is not unusual for a published paper to shift the focus from the drug's intended effect to a secondary effect that seems more favorable.
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well duh
so of course they go after the mommy.
it's sad, but unsurprising.
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Remember, we are talking drugs that could save or prolong lives here. If you take medical advice from a blogger, well then you get what you paid for. However, if you take medical advice from your doctor its a different story. Considering what we pay in premiums plus co-pays, I don't think its above and beyond to hope we would get truthful info and that somebody was watching for that.
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Get a life, look in the mirror... gov't oversight ain't the answer...
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Who will ensure compliance. You? You're too busy reading blogs.
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Go share your message of "use your brain" to the people in Bhopal. Or to the dead babies that drank melamine-laced milk powder in China.
Bottom line, talented con-men will sell you poison and tell you it's medicine. Less oversight means more poison...every...time.
You think you're so smart you can spot every con? You can smell the lead in your toothpaste? What a load of self-congratulatory BS. Good luck testing every product you buy to make sure it is pure, has no E. Coli, is poison-free, etc.
Hey...instead of each of us trying to do this endless task ourselves, why don't we address that issue collectively? Why is it some people don't understand that there IS a role for government? It is far more efficient to do product testing and certification centrally rather than have every person "use their brain".
It would be nice to have a functioning FDA, FTC, etc. to force some honesty in product marketing. Our gov't ain't perfect, but you should be careful what you wish for.
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FTFY...
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1. Oversight is a necessity, I agree, but it doesn't necessarily need to be the government. Independent privately-owned companies who add their stamp of approval to products in such a manner already exist. The difference is, if one of these companies is later found to be dishonest, you can stop looking for their stamp and go elsewhere. When the FDA is corrupt, you're stuck.
2. FDA regulation and oversight saves lives, it's true. It also costs lives. Every time the FDA slows down or prohibits the entry of a product onto the market, they are potentially costing the lives of people who could have been saved by that product in the meantime. To validate the existence of the FDA on the basis of saving lives, you'd have to prove that their control saves more lives than it costs, and that their control is better than the free market situation in #1 above. Neither of those is easy to prove one way or the other.
The bottom line for me, however, is that it should be my choice to seek out products not approved by the government, if I choose to take that risk. If I'm dying of terminal cancer, and the pharma industry has created a drug that cures cancer %10 of the time and kills the patient outright 90% of the time, I should be able to buy that product regardless of the FDA's opinion on the matter.
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Agree with you 100%. But your argument was far more nuanced than the "I'll just use my brain to protect myself" comment from edt. He seems to be kidding himself about the central role he has played in certifying that all his products were safe.
My father has written books on how products that are found to be poisonous by regulators in the US are promptly rounded up, put in containers, and shipped to developing countries where they can be sold without oversight. Being a consumer in those countries can be quite lethal.
Over there, each person needs to fend for themselves, though they are woefully equipped to do so. You'll note that I just argued that quality control is better done collectively, and by specialists. I've no love for the current crop of bureaucrats...only that they're occasionally better than nothing.
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You need to do more research
You really don't know what you're talking about do you? Clinical trials are REQUIRED and heavily regulated by the FDA. Yeah the pharma companies set up and run the trials, but every step of the way is under very strict FDA oversight. Furthermore, the majority of data collected from the trials are from labs, and not doctors. In fact, most doctors don't care about the result of a trial, they get paid either way, and many compounds do fail out somewhere along the way. Pharma companies are far more concerned about being sued than having to drop a bad compound. The point is, your argument for a bias is completely unfounded.
But I do agree the FTC's crack down on bloggers is absolutely insane.
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It's worse than that when you exam what KIND of corruption is going on at the FDA...the worst kind, direct!
You've got the FDA being directed by former pharma industry officers....yeah, that'll work out well.
Fox guarding the chicken coops, my friends...
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Pharma companies more concerned about being sued? Hardly. They settle out of court constantly (Eli Lilly swept countless wrongful death suits over Prozac under the rug) and the money they make from their drug monopolies is well worth it. These biased clinical trials don't even do much to make the drugs safer, they just give the manufacturers a "we did everything we could possibly be expected to do" defense in court.
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Yes, the doctors get paid for using their patients as lab rats whether their results are show to work or not. However, in the example given in the original article, the doctor also had millions of dollars invested in the company that would benefit from a positive result.
There is no evidence being presented that this or any other doctor is skewing their results to benefit their stock portfolio, but the simple fact that their stock portfolio may be impacted by their own part in this type of research is something that should be disclosed.
Now, why is the FTC is worrying about me disclosing the fact that Microsoft gave me a free zune player when I post a rave review of the thing on Facebook? Don't they have more important things to worry about getting proper disclosure on?
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1. The government does not have the resources to look into it all. So why divert even more resources to a sector that is by and large less of a threat to the health of citizens?
2. The government has plenty of resources, they just choose to look the other way for whatever popular reason you want to embrace. Which of course leaves even greater questions other than "why bloggers"?
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FDA looking at drug advertising issues with social media
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New Concept
This after all is a personal integrity issue both for doctors, lawyers and society at large. Maintaining health begins with food, restoring health usually can be achieved with specific compounds. So the food industry needs to be investigated and properly regulated, the prescription drug industry needs to be investigated and properly regulated, the medical establishment needs to be investigated and properly regulated. As to whose interests they serve, the interests of general public health or the interests of profits. In ancient China you did not pay the doctor unless you got well, you did not pay for treatments. This concept exists in contract pay types today, where you pay for a deliverable. Pay only for delivered outputs and not inputs, and gets rid of the "I don't have to produce a result" conflict of interest.
Look at the mess the good old USA in in now, because they are 20 years behind other developed countries in asking these questions, and acting on them, so profit is still the driving force, and look at the results. All the parties of interest me, me, me, me. And as to lawyers, well who is going to investigate them, over 50% of politicians are usually ex lawyers.
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Don't forget about the legislators
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Bloggers are pesky SOB's; they brought down Dan Rather and they threaten this administration's hammerlock on the media (except FOX) compared to Doctors who make lots of money and can be coerced into contributions.
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Want to limit malpractice claims? How about getting rid of bad doctors? Notice in none of the talks about malpractice does anyone talk about getting rid of bad doctors?
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Ugh, redux
Do you think it's possible that the FTC, as a fairly large organization, has the resources to look at both blogs and medical studies? Do you think, maybe, it would be entirely different people in the FTC for the two areas?
It's a complete straw man, and really beneath you, to handwave about how the FTC's (admittedly misguided) blogging regulations are somehow at the expense of properly regulating medical studies and advertising.
I promise you, at no time did someone at the FTC sit down and say "so, we have to choose between the advertorial issue in blogging and the corruption in medical studies... which will it be?" You're like the guy who complains about getting a speeding ticket when people can get away with crap like Enron. It's not a zero sum resource allocation problem, and each case or action should stand on its own merits, or lack thereof.
You're hurting Techdirt with this continuing highly emotional and poorly reasoned hyperventilating about the FTC's (stupid, poorly designed) blogging regulations. Please focus on stuff you can be relatively even-handed and intellectually honest about -- you do such fantastic work when you have that distance.
Sorry to be a downer and a critic; I love Techdirt and the bulk of your work. But this is really getting ridiculous. Though I guess the RIAA guys are probably happy about the new crusade.
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Yes, absolutely. I'm not saying it's one or the other. I'm just highlighting how silly the blogging rules are. Sorry if that wasn't clear.
You're hurting Techdirt with this continuing highly emotional and poorly reasoned hyperventilating about the FTC's (stupid, poorly designed) blogging regulations.
If we agree they are stupid and poorly designed, then what's wrong with me highlighting that?
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UV gullas college of medicine
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