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An analysis of nearly 600 registered clinical trials published online October 29 in BMJ has shown that 29% remained unpublished 5 years after completion, that no results were available in ClinicalTrials.gov for three fourths of those unpublished trials, and that industry-funded trials were nearly twice as likely to go unreported as studies that had not received industry funding.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 Trials.gov 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Their analysis included 585 registered trials, 171 of which (29%) remained unpublished. These unpublished studies included nearly 300,000 participants.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rate was 32% for industry-funded trials and 18% for those without industry funding (P = .003), and 78% of the unpublished trials also had no reported data in ClinicalTrials.gov.

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, ClinicalTrials.gov. 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.