Corrupted Research, Still

Abilify2This is a repost from 2009. I’m revisiting it because I think the situation has not gotten better. People all around me are becoming drug addicts – addicted to their legally prescribed drugs: benzodiazepines, opioid pain relievers – because the pharmaceutical industry has not been reigned in. There are antidepressants, sleeping pills, statins, and other drugs that don’t work well and have horrendous side effects. Just yesterday I read this FDA warning about a popular antidepressant, Abilify:

The U.S. Food and Drug Administration (FDA) is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced.
FDA Drug Safety Communication: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada), FDA, 3 May 2016

Here’s my old post:
________
When a former editor-in-chief of The New England Journal of Medicine, says:

It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”

It’s worth paying attention.

ConflictOfInterest1That quotation is by former NEJM editor Dr. Marcia Angell from her review of three recent books which (including one she authored herself) shine a light on the influence businesses, in this case drug companies, have on research that appears in even the most respected, peer-reviewed science and medical journals … and how businesses influence the behavior of medical professionals, in all fields – healthcare, research, academia, and government.

Here’s her review:
Drug Companies & Doctors: A Story of Corruption, New York Review of Books, January 2009.

I’ll list the books she was reviewing because I think their titles help tell the story:

  • Side Effects: A Prosecutor, A Whistleblower, And A Bestselling Antidepressant On Trial, by Alison Bass. This is the story of pharmaceutical giant GlaxoSmithKline, who “buried evidence that its top-selling antidepressant, Paxil, was ineffective and possibly harmful.” GSK agreed to settle charges of consumer fraud for $2.5 million – their cost for doing business, since Paxil continued to bring in about $3 billion a year.
  • Our Daily Meds: How The Pharmaceutical Companies Transformed Themselves Into Slick Marketing Machines And Hooked The Nation On Prescription Drugs, by Melody Petersen. The story of how drug companies engage in “disease-mongering,” convincing prospective patients and their doctors “that they have medical conditions that require long-term medical treatment.” Here, Pfizer pled guilty for illegally marketing Neurontin, laying out $430 million to resolve the charges. Again, this was just the cost of doing business, since Neurontin, which was initially approved to treat epilepsy, continued to bring in billions annually – for precisely the off-market uses Pfizer illegally advanced, “bipolar disease, post-traumatic stress disorder, insomnia, restless legs syndrome, hot flashes, migraines, tension headaches, and more.”
  • Shyness: How Normal Behavior Became A Sickness, by Christopher Lane. This is another story of disease-mongering: Drug makers creating diagnoses for which drug intervention is not indicated (e.g. the diagnosis of “social anxiety disorder” for shyness), let alone adequately researched, yet proceeding to aggressively market their drugs anyway.

Selling Pills On Inference Instead Of Science

The field of psychiatry is particularly vulnerable to disease-mongering since diagnoses are largely subjective. However, Senator Charles Grassley, who exposed damaging conflicts-of-interest in the psychiatry field, has shifted his attention to the cardiology field – where cocktails of powerful drugs are being peddled without the backing of convincing published scientific evidence. (The polypill for heart disease comes to mind. It’s an untested pill containing a statin, ACE inhibitor, diuretic, aspirin, and others.)

Ways Industries Corrupt Research

There are many ways that industries influence research. One is by suppressing unfavorable results of industry-sponsored studies. Here’s an example using antidepressants:

“Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive.”
Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, NEJM, 2008

Other ways include:

  • Setting up trials that are all but certain to show market worth, e.g. by comparing your drug to a placebo instead of to another similarly-classed drug.
  • Writing a paper that shifts focus away from a drug’s poorly substantiated primary effect to a peripheral effect that appears more favorable.
  • Reanalyzing data from published studies, that is, performing a “meta-analysis,” where included studies can be cherry-picked, or statistical analyses performed to deemphasize negative findings (i.e. broadening confidence intervals).

Dr. Angell says that “many reforms would be necessary to restore integrity to clinical research and medical practice. … Many would involve changes in the FDA.” I hope the new FDA Commissioner makes these reforms part of her agenda.

3 thoughts on “Corrupted Research, Still

  1. shaun

    A bit off topic:

    I feel like this warning may have some unintended consequences. We might start seeing folks pushing for their doc to prescribe Abilify to their spouse, but with an ulterior motive. They might be hoping for that spouse to develop the compulsive urge to . . . gamble.

    shaun

    Reply
      1. shaun j tillery

        Wouldn’t be the first time off-label use became the primary market for a prescription drug. 🙂

        Reply

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