The recent announcement by the British Medical Journal (BMJ) that starting January it will publish the results of human clinical trials only when there is a “commitment [by the sponsors] to make the relevant anonymised patient-level data” available on request is commendable. The immediate provocation could be its on-going three-year-long battle with Roche to make the pharmaceutical company share the complete trial data of Tamiflu — the antiviral drug used for fighting influenza. According to the BMJ, “about 60 per cent of data from Phase III trials … have never been published.” The journal’s bold decision will go a long way in stripping the drug industry’s shroud of secrecy around clinical trial data, and preventing it from withholding and distorting drug safety and effectiveness data. The BMJ decision comes close on the heels of GlaxoSmithKline’s announcement last month to make available to scientists the raw data of all trials carried out since 2007, of both “approved and abandoned drugs.” Next year will also see the European Medicines Agency providing access to clinical trial data submitted to it.
If journals vie with each other to publish the results of large-scale trials, they have a moral responsibility to ensure that the scientific community and medical practitioners are not misled, and patients’ lives are not endangered. History is replete with many high-profile cases where patients have suffered gravely as a result of incomplete and incorrect reporting of drug safety and effectiveness. The last few years have witnessed several measures aimed at bringing more transparency in the way trials are conducted and eliminating the cherry picking of data, the bane of trial results reporting. The International Committee of Medical Journal Editors took the first step when they made registration of all clinical trials post July 2005 a pre-requisite for publication of trial results in medical journals. Next, an American law made the submission of “basic results” of all U.S. clinical trials (except Phase I) mandatory with effect from September 2007. The noose is now tightening and drug companies know they cannot always claim that commercial interests override public health concerns.
BMJ move is much welcomed. I also commend the editorial efforts of the
Hindu in highlighting this issue. However, the fight is not over. We
need to ensure that all journals stay fall in line. More important is
the much pending strong legislation in India to control these trials
The British Medical Journals's decision to impose more transparency in
human clinical trials is most welcome. It is also a need to extend
the probing into the entire arena of medical and drug research in view
of the increased fraudulent and motivated "scientific studies". “New
diseases” and "new modalities of treatment" are often not found by
doctors, but by the long arm of the drug industry's marketing
departments to sell more drugs and more gadgets. They do this by
exerting great influence on organisations that formulate guidelines
and recommendations through “paid orchestrated opinion” of the
members of the committees and by creating “scientific” data through
“paid research.” They create new definitions and new sub-titles for
the existing diseases -- from high blood pressure to high
cholesterol to osteoporosis to obesity -- to “create” patients from hitherto normal population (by bringing them under the new definition)
to sell more drugs and more equipment.
The editorial very welcome. There are millions suffering due to side effects and other problems with approved allopathic drugs. Availability of clinical data will hopefully bring cherry picking of data and such other malpractices. It will go a long way in improving the health of common man.
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