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.

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.
And yet the FTC is more worried about a mommy blogger recommending a book that a publisher sent her for free?


Reader Comments (rss)

(Flattened / Threaded)

  1.  
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    Designerfx (profile), Oct 21st, 2009 @ 8:44am

    well duh

    said mommy doesn't have an entire lobbying industry and the government in her pocket.

    so of course they go after the mommy.

    it's sad, but unsurprising.

     

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  2.  
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    Anonymous Coward, Oct 21st, 2009 @ 8:50am

    One thing people should realize is that patents increase much of this corruption. If something wasn't patented there would be less incentive to lie about the results because lying about the results still only ensures everyone only gets a normal profit. With patents then those who have the patents have a monopoly which gives them more incentive to lie about the results and more resources to suppress studies from being conducted and data from being released that may show a drug to be more harmful than it really is. I talk more about that here (post 11).

     

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  3.  
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    Anonymous Coward, Oct 21st, 2009 @ 9:17am

    "the other car was speeding too" This is possibly the ultimate in poor defense.

     

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  4.  
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    A.Dub, Oct 21st, 2009 @ 9:23am

    Agree with Designerfx. The pharma lobby will keep this practice in place...be sure of that!

     

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  5.  
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    Anonymous Coward, Oct 21st, 2009 @ 9:33am

    Re:

    Good thing the defense is actually something more similar to "Officer, why are you stopping me for going 66 in a 65 while the bank robber drives by at 120?"

     

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  6.  
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    edt (profile), Oct 21st, 2009 @ 9:34am

    geez... how come no one uses their brain... oh, no we must have gov't oversight... if you don't trust your doc, get a 2nd opinion, or find a new doc... if the treatment/medication sounds too good to be true; it probably is...

    Get a life, look in the mirror... gov't oversight ain't the answer...

     

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  7.  
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    Dark Helmet (profile), Oct 21st, 2009 @ 9:38am

    Re:

    No, but a popular rejection of suspect groups by common folks IS the answer. The NIH, NIMH, WHO, and FDA are some of the most corrupt sum'bitches out there...

     

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  8.  
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    lx, Oct 21st, 2009 @ 9:42am

    You need to do more research

    ""clinical trials" -- which the pharma supporters always insist are so important"

    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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  9.  
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    Anonymous Coward, Oct 21st, 2009 @ 9:43am

    Ah, the old "People can't do more than one thing" fallacy. I suppose you were one of the folks who complained that Obama thought it was "more important" to make college basketball picks than work on policy_issue_x. Because of course people can't do more than one thing! In fact, my posting here shows that I find making random comments on blogs more important than my job! Because I can't do both.

     

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  10.  
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    Marcus Carab (profile), Oct 21st, 2009 @ 9:44am

    Re:

    Or, "why are you adding more speed traps to deserted highways than busy school zones?"

     

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  11.  
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    TDR, Oct 21st, 2009 @ 9:46am

    Re: You need to do more research

    And apparently you didn't see what DH just said - that the FDA itself is corrupt. So a corrupt industry being "regulated" by a corrupt agency isn't exactly overflowing with credibility.

     

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  12.  
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    Anonymous Coward, Oct 21st, 2009 @ 9:48am

    Is it possible that the other matter against which you rail might also be in the FTC's sights for action?

     

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  13.  
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    Anonymous Coward, Oct 21st, 2009 @ 9:50am

    Re: You need to do more research

    Hi, regulatory capture would like to speak with you.

     

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  14.  
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    Marcus Carab (profile), Oct 21st, 2009 @ 9:52am

    Re: You need to do more research

    Clearly the results of the systematic review show something different. FDA oversight or not, those numbers on the reporting of positive versus negative studies are incredibly troubling. There is obviously a bias in favour of the drug manufacturers, and the fact that there is FDA oversight only suggests that the FDA is ignoring or even contributing to that bias.

    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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  15.  
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    Dark Helmet (profile), Oct 21st, 2009 @ 9:55am

    Re: Re: You need to do more research

    "And apparently you didn't see what DH just said - that the FDA itself is corrupt. So a corrupt industry being "regulated" by a corrupt agency isn't exactly overflowing with credibility."

    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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  16.  
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    Thomas O'Toole (profile), Oct 21st, 2009 @ 9:56am

    FDA looking at drug advertising issues with social media

    Mike, this doesn't really speak to concerns about capture, but the FDA is considering amending its drug disclosure rules as they pertain to social media. Here is a link to the Federal Register announcement. The agency will hold public hearings in Wash DC next month, Nov. 12-13.

     

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  17.  
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    Michael, Oct 21st, 2009 @ 10:00am

    Re: You need to do more research

    The point is not that the clinical trials are being regulated poorly or that they are relying heavily on bad information. The point is that some of the information the trials are being based on is being provided by doctors that seem to often have a major conflict of interest.

    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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  18.  
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    bigpicture, Oct 21st, 2009 @ 10:14am

    New Concept

    Is this a new concept? Since the medical and legal professions started there has always been this "conflict of interest" issue, that is largely ignored in the USA. A doctor makes more money by keeping a patient ill, and a lawyer makes more money by advocating divorces, litigations etc. So then how does a patient get cured? How do people with disagreements get reasonable resolution?

    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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  19.  
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    DocMenach (profile), Oct 21st, 2009 @ 10:19am

    Don't forget about the legislators

    To compound the problem even further our "representatives" in Congress and Senate usually have large amounts of money invested in pharma companies. So they don't want to introduce any legislation that may affect their investments.

     

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  20.  
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    Dr. Kill joy, Oct 21st, 2009 @ 10:28am

    Re:

    It is not just do I trust my doctor, but do I trust who my doctor trusts. The problem is the research that your doctor is supposed to trust is tainted, then he can not make an informed decision. Unfortunately, the norm growing is to consider that there are not multiple quality studies to prove efficacy ( or disprove effect).

    Who will ensure compliance. You? You're too busy reading blogs.

     

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  21.  
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    Derek Kerton (profile), Oct 21st, 2009 @ 10:35am

    Re:

    Spoken like a spoiled American who has benefited from gov't oversight all his/her life.

    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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  22.  
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    Dark Helmet (profile), Oct 21st, 2009 @ 10:48am

    Re: Re:

    "Bottom line, talented con-men named Rockefeller will sell you oil and tell you it's medicine."

    FTFY...

     

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  23.  
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    Taoareyou, Oct 21st, 2009 @ 10:49am

    Re:

    It's not about being able to do two things at once. It's about available resources, which the government does not have. If your work day is 8 hours and you respond to blog posts for six of those hours, then what you can accomplish at work will suffer. It has been demonstrated that there is already a lack of oversight in the pharma industry. So we have two conclusions:

    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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  24.  
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    drkkgt (profile), Oct 21st, 2009 @ 11:11am

    Re: Re:

    or why are you pulling me over when that guy over there just killed someone and you are letting him go.

    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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  25.  
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    Chris Rhodes (profile), Oct 21st, 2009 @ 11:28am

    Re: Re:

    Two comments:

    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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  26.  
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    Flyfish, Oct 21st, 2009 @ 12:09pm

    This is about the use of intimidation to squelch blogs that are critical of the administration.

    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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  27.  
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    Anonymous Coward, Oct 21st, 2009 @ 12:24pm

    Easy fix for this and it has nothing to do with the drug companies. Since the doctor is accepting money for this, when they endorse or push a bad drug, they should lose their license.

    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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  28.  
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    Brooks (profile), Oct 21st, 2009 @ 12:46pm

    Ugh, redux

    Oh, come on, Mike, please. Last time I pointed out your highly emotional take the FTC blogger regulations, you 1) denied that the regulations apply to Techdirt, and then 2) posted some pretty amusing snark later in the day about how they apply to Techdirt (the whole "got free cable service due to technical glitch a few years ago" thing).

    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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  29.  
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    Anonymous Coward, Oct 21st, 2009 @ 1:54pm

    Re:

    Hi Glenn, how are you?

     

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  30.  
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    Mike Masnick (profile), Oct 21st, 2009 @ 3:31pm

    Re: 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?

    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?

     

    reply to this | link to this | view in thread ]

  31.  
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    Anonymous Coward, Oct 21st, 2009 @ 4:50pm

    Re:

    Where is this argument when it comes to blogs then?

     

    reply to this | link to this | view in thread ]

  32.  
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    Anonymous Coward, Oct 21st, 2009 @ 5:02pm

    Re: FDA looking at drug advertising issues with social media

    Sounds like a scam to stifle any free speech threatening pharmaceutical profits over the Internet.

     

    reply to this | link to this | view in thread ]

  33.  
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    Derek Kerton (profile), Oct 21st, 2009 @ 9:30pm

    Re: Re: Re:

    Chris,

    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.

     

    reply to this | link to this | view in thread ]


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