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Medicine Government United States

Unearthing Fraud In Medical Trials 80

An anonymous reader writes: The U.S. Food and Drug Administration holds a position of trust among citizens that few government agencies share. So when NYU professor Charles Seife found out the FDA is not forthcoming about misconduct in the scientific trials it oversees, he and his class set out to bring it to light. "For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn't get forthright answers." Seife suggests the FDA is trapped in a co-dependent relationship with the pharmaceutical industry, and needs strong legislative support to end its bad behavior.
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Unearthing Fraud In Medical Trials

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  • by Anonymous Coward

    "...the FDA is trapped in a co-dependent relationship with the pharmaceutical *and food* industry."

  • by g0bshiTe ( 596213 ) on Friday February 13, 2015 @06:42PM (#49051385)
    So sick of hearing "US knows of wrongdoing, we have proof" yet never ever is there any accountability.

    Wake up people it's time to make Washington work and listen to us again!
    • Re:Yawn (Score:4, Insightful)

      by ihtoit ( 3393327 ) on Friday February 13, 2015 @06:44PM (#49051403)

      there is no accountability because Government is nothing more than puppetry for industry.

      You get what you pay for.

      • by rtb61 ( 674572 )

        Far more accurately you get the government that you allow the corporations to buy and you are the one that ends up stuck with the bill.

      • there is no accountability because Government is nothing more than puppetry for industry.

        You get what you pay for.

        When it comes to government, you get what other people pay for. You don't have the option to pay nothing/get nothing.

        • Re: (Score:1, Troll)

          by dryeo ( 100693 )

          It's a free country, you have just as much right to spend hundreds of millions of dollars to buy your own laws. Of course being a free country means others have the right to outbid you.

    • If anyone, anywhere wonders where the anti-vax movement came from, here you go. I am NOT defending the antivaxxers. Vaccinate your kids, dammit, and yourself too! But is it any wonder that people have come to systematically distrust experts when the institutions of expertise have been shown repeatedly to be corrupt to their core?
      I am agnostic as to whether we have more corruption than we used to, or just more public awareness of it. I suspect the latter case, but it doesn't really matter. Getting pe
      • Re: (Score:2, Insightful)

        by s.petry ( 762400 )

        No, Yes, No, and No again.

        No to the first part is based on who owns the argument and what they want your perception to be. Hint: It may not be the real argument.

        Remember that 5 companies that own all broadcast media in the US, Government agencies like the FDA are revolving doors for agriculture and pharmaceutical company exec's, many News Papers have been complicit in cover ups (see NY Post whistle blowers, Washington Post, etc..). Finally consider that even small papers rely on Government agencies lik

        • What numbers?

          The ones available from the FDA? The CDC? Some other government agency?

          • by s.petry ( 762400 )

            I think you are trying to hint that the CDC is not accurate. I'm pretty sure they are kind of accurate, but to get the real picture you have to dig pretty damn hard into their information. They don't make it easy.

            Have a better site for numbers that can't be flagged as biased? I'll take a look.

      • One only need look at a picture of a Polio Ward to know the truth. As for those that do not 'vax their decendents? They can watch them die.
  • by bigfinger76 ( 2923613 ) on Friday February 13, 2015 @06:47PM (#49051425)
    The FDA probably just doesn't have enough women.
  • by Anonymous Coward

    The FDA is co-dependent? What are you smoking?

    Medicare+Medicate is 2-3% of your total pay. Plus heaven forbid you ever have to use it for something serious, then they treat it like a loan and come in and start taking your property.

    Health insurance (now Mandatory!) is $80-120\month\person that you see on your check; on the other side is the $400-600 a month you do not get to see.

    Plus the exemptions to Antitrust laws that would make a Robber Barron blush.

    "Oh but my family insurance is only $180 a month! For

  • by javilon ( 99157 ) on Friday February 13, 2015 @06:48PM (#49051435) Homepage

    Seife suggests the FDA is trapped in a co-dependent relationship with the pharmaceutical industry, and needs strong legislative support to end its bad behavior.

    This is clearly the case, and this not only means that some drugs that should not be on the market are approved. It also means, and in my mind this is more important, that the big Pharma are using the FDA as a barrier of entry against startups. Getting a new drug on the market costs an average of $2.558 billion [thomsonreuters.com] in 2013 dollars.

    This days are the early days of the biotech revolution where we will gain enormous control over our health are just starting, and progress is slow due to regulation capture. If some of this money would be given back to researchers instead of lawyers and bureaucrats, we would get better treatments available sooner.

    As an example, big pharma companies get old drugs whose patents are about to run out, change their chemical formula and improve them just a bit and then go to market with them so the can reap huge margins with basically the same compound. This is safer business than trying to produce a breakthrough with a completely new compound. And the reason for this is the way the FDA operates. This results in very valuable resources being used with little benefit to the public.

    • by rock_climbing_guy ( 630276 ) on Friday February 13, 2015 @07:18PM (#49051605) Journal
      A million times this. I recently heard some news about a new medical discovery. It is a treatment for a chronic illness called "cluster headache", which reportedly causes such severe pain that people literally kill themselves to stop the pain.

      A CH sufferer serendipitously discovered that using LSD recreationally stopped his pain. Word quickly spread among CH sufferers, but as you can imagine, they were worried about being busted by the man who wears the badge.

      A medical researcher got wind of this and did some rudimentary research on a drug that is chemically similar to LSD, but does not cause a "high"; in other words, it has no abuse potential. He made a remarkable discovery: many of the patients he studied reported that taking just THREE DOSES PER YEAR stopped the pain.

      The problem then, is that the illness is rare enough that you could never make back $2.5 billion dollars selling three pills per year to patients, so no big pharma company would want to go thru all the red tape to get it approved by the FDA. As a result, there remains no effective FDA-approved treatment for CH.

      Many of these patients continue to self-medicate with old-fashioned LSD while looking over their shoulder for "The Man". How sad....

      Profit indeed comes before people, but I had no idea how abusive the system could be. And for the record, I do not have CH.

      • The "average" is supposedly $2.5B, that doesn't mean they all cost that much (or little), the money is mainly spent on clinical trials. Part of the problem is that many countries (including mine) rely heavily on the FDA, they take the fruit of the trials for free. The problem with LSD in particular is that it is on the wrong side of the drug war. Adults should be free to take whatever drugs they want and should not be forced to have vaccines.

        However consumers should be held responsible for their decision
      • by Dorianny ( 1847922 ) on Friday February 13, 2015 @08:20PM (#49051931) Journal

        The problem then, is that the illness is rare enough that you could never make back $2.5 billion dollars selling three pills per year to patients, so no big pharma company would want to go thru all the red tape to get it approved by the FDA. As a result, there remains no effective FDA-approved treatment for CH.

        Under U.S law rare diseases are designated as "orphan disease" and the FDA can give " orphan drug" status to drugs specifically targeting the rare disease. The law gives tax incentives, enhanced patent protection and even subsidizes clinical research. In the U.S there is more than 300 orphan designated drugs under clinical trial process. The problem with your LSD like chemical is that it is likely so similar that you are in dubious legal ground with regard to anti-drug legislation. That is not the fault of either the FDA or the pharmaceutical industry.

        • by Anonymous Coward

          The problem with your LSD like chemical is that it is likely so similar that you are in dubious legal ground with regard to anti-drug legislation. That is not the fault of either the FDA or the pharmaceutical industry.

          Neither the FDA nor the industry wants Americans to have unregulated access to drugs. Nor do they want us to have regulated access to the same drugs Europeans or Canadians or Mexicans can buy. Nor do they want to compete with recreationals (vs anti-depressents, their brand of happy pills, et

      • Sorry but this is just not believable, a large part of the cost of developing a drug is to put in place clinical trials in humans, the "rudimentary research" that this medical researcher did actually would be exactly this. First he had to finish a large number of toxicity tests on cells and animals just to give a single dose to a human, and if he treated patients then he already had to finish the safety test (done on completely healthy volunteers) on top of that he already got to test humans for at least a

    • by fermion ( 181285 )
      Also the washington post reports a John Oliver story that most pharma companies spend more on marketing than research. A number of stories has come out over the past few years indicated that phramcos essentially pay doctors to prescribe their drugs.

      The real issue here is the idea that medical science is in fact a science. It may have elements of science, but if science is to flourish we must root for the null hypothesis, and there is no incentive in medical science to so do.

      No, everyone want to believ

  • FDA due for reform (Score:3, Interesting)

    by jd.schmidt ( 919212 ) on Friday February 13, 2015 @06:48PM (#49051437)
    The FDA should have it's scope limited somewhat, focusing more on purity of things is regulates and less on effectiveness and uses. I have heard of various cases of outside influence and political pressure in the past. I think a more open source/wiki approach to medication effectiveness might be better. There is always a big danger of misuse when so much is relying on one organization with no outside checks.
    • I think it should serve two purposes. One like you mention is purely. Make sure what the manufacturer says is in there is correct.

      The second is continue doing trials but only as an advisory function. If companies want to pay for the FDA seal of approval so be it. If not you can sell your drug with a warning it hasn't been tested.

      I try to to take drugs that have been out for 20-30 years. If I was really sick I might get more desperate.

    • You could start by putting a stop to the sting ops and SWAT raids on farmers who sell raw milk.
      • A SWAT raid seems a tad excessive but I assume you're posting from the US, so who knows? However, there's good public health reasons for banning the sale of raw milk, nobody is banning foolhardy and ignorant nature nuts drinking it straight from the cow, they are stopping people from profiting from the ignorance of others. Pasteurising milk is simply the act of boiling the milk to kill the nasties (such as tuberculosis), it used to be called "scalding the milk" before anyone figured out why it worked. Homog
      • no, not at all, that crap kills people .

    • Relying on the open/wiki opinion of every Tom, Dick, and Harry is much better than using objective scientific blinded clinical trials. Yeah, that will work.

    • by Rockoon ( 1252108 ) on Saturday February 14, 2015 @11:43AM (#49054735)

      The FDA should have it's scope limited somewhat, focusing more on purity of things is regulates and less on effectiveness and uses.

      Prior to 1962 the FDA only required proof of safety before a drug could be sold and marketed. The mandate was changed in 1962 to include efficacy, and the excuse for doing so were the birth defects caused by thalidomide in Europe. Note that thalidomide was quite effective, but not safe, which is why the FDA already didn't allow it to be marketed or sold in the United States. The FDA pounded its own chest and asked congress for more control even though it didn't need it to prevent thalidomide birth defects in the States, and thus congress passed the Kefauver-Harris Drug Amendment.

      Thats it right there. Before 1962 the FDA didn't care about efficacy. After 1962 it did, and all because the FDA's safety mandate was good enough.

  • by sdinfoserv ( 1793266 ) on Friday February 13, 2015 @06:49PM (#49051451) Homepage
    Most government agencies are mere puppets for the owned representatives in office. Like the FDA, the EPA will not protect the interest of the citizens but rather corporate interests. Many victims of fracking where once fertile land has become toxic have found the EPA's sole job is to protect the frrackers, not the land they supposedly steward. Commerce Department is another example. The Commerce Departments job is to protect and secure 'commerce' not individuals but huge corporations. The FBI diligently attacks people who illegally share music - with the same ferocity as mass murders or terrorists.

    Net neutrality will become another victim. It will eventually die since It 'burdens' profiteers.

    . Our rights as citizens is a veneer. Till we change how campaigns are financed, corporate puppets will continue to operate with impunity sealing more and more wealth from the masses for the benefit of the few.
  • by bogaboga ( 793279 ) on Friday February 13, 2015 @07:02PM (#49051525)

    Didn't they agree to this [weeksmd.com] long ago? What do you expect anyway?

    From the piece, authored more than half a decade go, "The FDA now admits that Americans are suffering and dying because the FDA does not have the scientific ability to ascertain if new drugs are safe or effective or to evaluate scientific claims." (Bold mine).

    What troubles me though, is that most Americans believe our country has the "best" medicine or healthcare one can find anywhere on planet earth.

    • by Duckman5 ( 665208 ) on Friday February 13, 2015 @09:32PM (#49052397)

      Are you kidding me? Did you read where that came from? It's reposted from Mercola.com. The guy is a anti-vaxx quack [whale.to] with a minor history of battling with the fda. [wikipedia.org] Not only that, but those extra regulations on supplements threaten his livelihood [mercola.com].

      Does any of that mean that the FDA is perfect? No. The structure of the FDA is retarded. They require a whole series of clinical trials, have the evidence presented to their advisory team (composed of actual scientist and medical professionals) who make a recommendation, then a group of people (who have no legal requirement to know ANYTHING about medicine) vote on whether to approve the drug or not. That's how you end up with stupid garbage like Aricept 23mg getting regulatory approval (Over 2x the side effects with almost negligible gain on Mini Metal Status Exam compared to the 10mg dose? Yay! Put Grandpa on it today!)

      The FDA is also only allowed to look at safety and efficacy data. They can't deny something on the basis of utility. Companies like this one [stiefel.com] make a killing on it. I'm not aware of a single novel medication that company makes. All they do is take stuff that has been on the market for decades, make it a gel instead of a cream or combine two products (so convenient), sell it for 10 or 20 times the generic price, and send an army of sales reps to convince gullible dermatologists to prescribe their products.

      It would be crazy if it weren't true. There are some serious problems with the FDA that need to resolved. The ability to assess whether something is safe/effective or not is not one of them. The testing process is sound. The requirement to listen to the people who CAN assess the results, however, needs to be changed. Just for crying out loud, don't use Mercola as a source. His scientific reasoning ability is clearly questionable.

  • to realize something shifty is going on when drugs that mask/fix one problem cause 10 other ones or death at time or serious addictions. How can a drug that causes death in some instances be allowed on the market?

    My wife was put on some anti anxiety drugs by her doctor. It made her feel like shit and gave her nasty shakes. She stopped taking it and went back to the doctor a couple weeks later. He gave her a big speal that she cant do that as it could have cause her to commit suicide WTF!!!!!!!!!!!!! and she

    • Lemme guess - Zoloft?
    • This is true of all SSRIs. There are withdrawal symptoms and you're supposed to taper off to minimize them. Her doctor should have explained this to her, the pharmacist should have explained this to her, the prescription most likely came with literature explaining this, and there should have been a sticker on the bottle warning to her consult her doctor before stopping it. I had the same issues with Celexa, but tolerate Lexapro without issue. The side effects SSRIs are far better than the older tri-cyc

  • by BoRegardless ( 721219 ) on Friday February 13, 2015 @07:05PM (#49051549)

    Do you work for the FDA for a government civil servant wage reviewing other company's work or do you go to work for industry and earn the wage you trained for?

    Same thing at the US Patent & Trademark office. Patent examiners come in, learn the ropes and go out to become patent attorneys in the private sector.

    Same thing happens at the IRS.

    Government doesn't keep the brightest bulbs because of pay and bureaucracy.

    • Apparently you are under the misguided perception that the FDA does drug development. That is incorrect. The FDA does product evaluation, which is something that private industry only does because they are forced to. And I can tell you that there is no collection of scientists in the world who know more about product evaluation than there are at the FDA.

  • ...suggesting the "FDA is in a co-dependent relationship with the pharmaceutics industry and need strong legislative support to end this bad behavior"? Is there no such thing as accountability anymore? Are we all so hopelessly helpless we need some great (HIGHER-KNOWING/wise) ~~group~~ to come along and help us wipe our A$$ES? My guess is the TF Author simply ~~wants~~ to be ~~reamed out~~.
  • by slew ( 2918 ) on Friday February 13, 2015 @07:50PM (#49051753)

    Seife suggests the FDA is trapped in a co-dependent relationship with the pharmaceutical industry, and needs strong legislative support to end its bad behavior.

    He wants the completely-non-influenced-by-big-money legislature to do something about the FDA being co-dependent with big-pharma...

    Yeah, that sounds like it's gonna work...

  • by Kludge ( 13653 ) on Saturday February 14, 2015 @12:19AM (#49053047)

    This article reads like the hack job that it is.

    So as part of my investigative reporting class at New York University, my students and I ...

    Something tells me that these people do not know a lot about science or drug evaluation, but do know a lot about trying to make a big splash with an article that "exposes" wrongdoing.

    Here's a small dose of reality: All studies and clinical trials have things wrong with them. Everytime I read a study in JAMA and the NEJM, I can point out half a dozen things that should have been done differently. When evaluating whether a drug or procedure or implant is effective you always have to read these studies with a critical eye, and consider all the evidence (laboratory, clinical, statistical, etc.) when making a decision.

    The fact that some "investigative reporting" students found problems with clinical studies is hardly surprising given how many details the federal government regularly documents and records.

  • But we still should all go out and get every damn flu shot that they say we should. Because even though there is fraud, it is still very sound science and there is no fraud going on. Their trust is and always will be at the highest levels. And if you don't have the required levels of trust then you must report for your social mind reconfiguration training.

    Thank you citizens!

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