Tuesday, November 19, 2013

Pharma Still Up to its Old Tricks

It looks as though big Pharma is still up to one of its most disturbing practices: not publishing or making public studies that show that its products might be ineffective. As described by my colleague Peter Parry later in this post, we had thought this problem was successfully addressed back in 2010.  

Apparently not.

And do not think this problem is unique to psychiatric medications. 

Of course, as I have pointed out several times in this blog, recruitment and assessment of subjects for many research studies these days has become so warped by financial incentives that many of the studies, published or not, are not worth the paper they are printed on to begin with. 

And some studies are purposely designed to mislead readers into believing that certain generic drugs, particularly antidepressants, are not effective when in fact, when used properly for the right patients, they are among the most effective drugs in all of medicine. But that's a 'hole 'nuther issue.

To get back to the issue at hand:

From Medscape, 10/29/13: 

An analysis of nearly 600 registered clinical trials published online October 29 in BMJ has shown that 29% remained unpublished 5 years after completion, that no results were available in for three fourths of those unpublished trials, and that industry-funded trials were nearly twice as likely to go unreported as studies that had not received industry funding.

Previous studies have shown that published trials contain less than half of the patient-outcomes data contained in company-controlled documents.

Dr. Jones and colleagues from the University of North Carolina, Chapel Hill, conducted a cross-sectional analysis of trials that had at least 500 participants and had been prospectively registered with Clinical and completed before January 2009. 

Their analysis included 585 registered trials, 171 of which (29%) remained unpublished. These unpublished studies included nearly 300,000 participants.

"By focusing our investigation on studies with at least 500 participants, we greatly limited the possibility that non-publication of trials in this cohort was due to rejection of manuscripts by journals or a lack of time or interest on the part of investigators or sponsors," the authors write.

The non-publication rate was 32% for industry-funded trials and 18% for those without industry funding (P = .003), and 78% of the unpublished trials also had no reported data in

From Peter Parry (on the webpage TheConversation.Edu.Au):

Dr. Peter Parry
A large proportion of drug trials, particularly those sponsored by pharmaceutical companies, never get published, skewing our picture of drugs' effectiveness and safety.
Research published in 2010 showed results unfavorable to sponsored drugs are less likely to be published, or selectively published to put a favorable spin on poor results.  And internal pharmaceutical industry documents released from court cases show concealment of data is a widespread practice.

A colleague and I assessed such documents about psychiatric medications from five pharmaceutical companies. The papers suggested widespread overstatement of benefits and understatement of adverse effects. Other researchers have found similar problems with different drugs.
In response, some medical journals voluntarily agreed to publish only studies registered on a website of the US National Institutes of Health, At least studies with unfavorable results would not be buried by drug companies. But the BMJ article confirms that many registered studies still don’t get published.

The AllTrials initiative aims to make the (de-identified) results and methodology of drug trials available to independent researchers so journals can publish in-depth articles based on all of the full data.

In 11 months, the campaign’s petition has gathered over 59,000 individual signatories and over 400 medical and health-care organizations. These include many British medical colleges and learned academic medical science institutions, such as the Cochrane Collaboration and the British National Institute for Health and Clinical Excellence (NICE).

Although the campaign is progressing slower outside the United Kingdom, it is managing to get some traction internationally.

The World Association of Medical Editors (WAME), the South African Medical Research Council and the Canadian Agency for Drugs and Technology in Health have signed.

Maybe there is still hope this problem can be rectified.


  1. On the other hand, trials with woefully low amount of partcipants, not blind etc etc are routinely published.

  2. The problems with pharma research are not restricted to psychiatric drugs, but the last 30 years of psychiatric research has been fairly thoroughly undermined, more so than in other specialties.


      I call psychiatry the drug industry’s paradise.”
      -- Peter Gøtzsche, Director of The Nordic Cochrane Centre

    2. Alto

      Ugh! I hate to disagree with you so vehemently but: The MISUSE of psych drugs is serious enough enough (in people that don't need them or in just snowing patients with sedation) without having to grossly exaggerate the dangers like Gotzche is doing.

      He just makes the REAL pharma critics like me suspect in the minds of the public, and interferes with us gaining a real audience. That makes him part of the problem, not the solution.

      How dare he use the already discredited serotonin model of how antidepressants work to argue that they do not work at all. He needs to spend some time in a well-run psychiatric hospital with some real, honest-to-goodness melancholic depressives before he goes spouting off. Maybe spend some time with some non-psychiatrist neuroscientists. Antidepressants saved my life, that's for DAMN sure.

      Looking at "studies" alone as he is actually doing, even if you pool them, is a fool's errand. He says so himself! The studies are easily manipulated.

      The exaggerations he makes sound exactly like the way NIDA exaggerates the dangers of pot and cocaine, thereby allowing a racist war on poor black people in the legal system.

    3. I didn't interpret his remarks in that video that way.

      Psychiatry certainly hasn't done any favors for its reputation by claiming antidepressants correct a chemical imbalance or drawing analogies to insulin.

      He's not throwing out psych drugs altogether. He says "these drugs should be given for as short a period as possible."

      I think his conclusion that harm from psychiatric drugs is much greater than psychiatry knows (or admits) is inescapable.

      He's extrapolated some rates of injury from available studies and statistics. A clinician's-eye view can't estimate this.

      Refuting the studies is essential, since they're what psychiatry uses to support its claims -- and clinical practice, by the way!

      As for MISUSE of psych drugs -- I presume you mean in treatment by clinicians -- you might argue a good doctor is good for patients and a bad doctor is bad. I can't disagree with that tautology. But why is it so easy to find bad doctors and so hard to find good doctors?

      I once had correspondence with a very nice Australian psychiatrist who was citing the STAR*D study as a basis for treatment recommendations. He agreed the study was invalid, yet defended referring to it: "It's all we've got." !!!!!!!!!!!!

      If that's what clinical practice is based on, clinical practice is in deep, deep trouble -- as so many patients know. What other medical specialty has a large, identifiable "anti-" group?

      (I especially appreciate Gøtzsche's observation that people often have a very hard time going off psychiatric drugs -- a point of tremendous denial among psychiatrists, yet borne out by hundreds of thousands of complaints all over the Web. I wonder how he found out about that.)

      Given the huge flaws in psychiatry, I'm sure there's room for more than one pharma critic perspective.

      Antidepressants saved your life? That sounds like it's an interesting story....

      (PS What don't I see you commenting on

    4. I think I would have seen all this harm you're talking about from antidepressants in 35 years of presribing them and following patients long term, if it was there. Again, if a patient does not tolerate a given drug, I take them off of it, and if they have trouble tapering, I taper more slowly, so no harm is caused there. There is NO valid evidence that the drugs, when tolerated, CAUSE or worsen depression long term. That's just nonsense. Of course I've seen tardive dyskinesia and metabolic syndrome with antipsychotics, so that's harmful, but so is being a street person or ending up in jail for minor crimes caused by delusions. It's always risk vs. benefit, and even those harms can be monitored for.

    5. Why so many bad docs? Easy. 1. Thanks to my old buddy Ronnie Reagan, academic medicine has been taken over by pharma shills who then "teach." 2. Managed care insurance ratcheting down remuneration for psychotherapy. 3. Everybody these days wants a pill instead of dealing with messy family and psychological issue

    6. Okay, so we agree there are an excessive number of bad doctors in psychiatry (and elsewhere).

      And -- those bad doctors ARE injuring people with psychiatric drugs. Because you carefully monitor your patients, you head off injury. You cannot generalize from your experience.

      There are many, many doctors, including psychiatrists, who do NOT take people off psychiatric drugs when adverse effects occur. They either bully the patient into staying on the drug, often with increased dosage, or add other drugs to counter the adverse effects.

      Long-term, that inappropriate drug regimen causes serious neurological problems. (And about your colleagues knowing how to discontinue drugs -- don't get me started.)

      I'm not generalizing from my own opinion, I can show you 1,000 case reports following this pattern.

      As inanimate objects, prescription drugs don't injure people, doctors injure people. Emphasizing the dangers of psychiatric drugs 1) Redresses the exaggeration of benefit that is the legacy of that pharma influence; 2) May discourage people from asking for them; 3) As a very long shot, may educate doctors.

      (Still would like to hear about your personal experience with antidepressants.)