1 Boring Old Man

Medical Journal to Require More Details on Drug Trials
New York Times
By KATIE THOMAS
October 31, 2012

The British Medical Journal has announced that, beginning in January, it will no longer publish the results of clinical trials unless drug companies and researchers agree to provide detailed study data on request. The decision by the prominent journal is meant to prod pharmaceutical companies to open up the vast quantities of data they collect in researching new drugs, very little of which is ever made public. Critics say that when results are published in medical journals, they often present a drug in the best possible light and do not permit independent researchers to vet the data. Dr. Fiona Godlee, editor of The British Medical Journal, said in an interview Wednesday that she hoped other major journals would follow suit. “We expect that eventually this will become the norm,” Ms. Godlee said.

Peter Doshi, a postdoctoral fellow at Johns Hopkins University School of Medicine who has publicly tussled with the drug maker Roche to release more data on the anti-influenza drug Tamiflu, applauded the announcement. “I think that’s a very powerful and important step,” he said. Dr. Godlee said that the details of the policy were still being determined, but that any author wishing to be published in the journal would have to promise to release patient-level trial data to researchers who made a “reasonable request.” She said the journal would publicize instances in which requests were rejected. Dr. Howard Bauchner, editor in chief of The Journal of the American Medical Association, said there were many ways to address the issue, and he believed that the industry wanted to “get this right.” He pointed to a recent announcement by the drug maker GlaxoSmithKline that it would make detailed data available. A spokeswoman for The New England Journal of Medicine said the journal did not comment on the policies of other publications.

In a statement, Matthew Bennett, senior vice president of PhRMA, a pharmaceutical industry trade group, said that the industry was committed to transparency and that members already submitted information about all clinical trials to a federal Web site, which includes basic information about the studies but not patient-level data. He said the group had concerns about releasing such detailed data, saying it “could not only lead to misinterpretation of the risks and benefits of medicines, and potentially interfere with patient confidentiality, but would also deter future medical innovation if would-be competitors could access confidential commercial information.”

• "… members already submitted information about all clinical trials to a federal Web site, which includes basic information about the studies but not patient-level data"
  He’s referring to clinicaltrials.gov [see bring on the hoops! [at least the ones that matter]…]. As those of us who use that site know only too well, it is the most under-utilized mandatory site in history – rarely containing the results of clinical trials. There is, in fact, a Bill in Congress right now designed to beef up reporting there [the TEST Act…]. Here’s the truth:
  
  The TEST Act will help in terms of alerting us to negative trials and will certainly make things better in other ways, but it will not require the raw dataset [patient level data] so it’s of no use to peer reviewers. You can jury-rig the clinicaltrial.gov results database report as easily as they have jury-rigged the journal articles.
• "… lead to misinterpretation of the risks and benefits of medicines"
  They keep saying that. The whole point of data transparency is to keep the pharmaceutical industry from their chronic misinterpretation of the risks and benefits of medicines! The truth is that it will be a lot harder to sell oversell medicines if people actually know what they’re taking. Exactly! The truth is not misinterpretation of the risks and benefits of medicines. It’s the opposite…
• "… potentially interfere with patient confidentiality"
  Yawn. Encoding clinical data is a piece of cake. These are patients have agreed to be subjects by signing on to be in a study. The data is seen by reviewers, not in the local paper. This is a gratuitous argument – pharma using medical ethics for nefarious reasons.
• "… deter future medical innovation if would-be competitors could access confidential commercial information"
  We come now to the crux of things. They want to continue to play those games that companies play with their products –
  accentuate the positive
  eliminate the negative
  latch on to the affirmative
  and don’t mess with mister in-between.
  It’s the right of a capitalist enterprise – not telling us that Dr. Pepper is made out of Prune Juice because Pepsi might find out. Well that’s the beauty of the BMJ decision. They can continue to do that as long as they want to. That’s their business. All the BMJ is saying is that if that’s what they want to do, fine – but they can’t use the scientific medical literature [or at least the BMJ] as part of their ad campaign.