Citing her publication’s expectation “that eventually this will become the norm,” the editor of the internationally prominent British Medical Journal recently discussed a material change in the journal’s publishing guidelines relating to drug companies’ clinical trials.
Dr. Fiona Godlee said that, going forward, the journal will not publish any study carried out by a drug manufacturer if the company does not agree in advance to release trial-related information to any researcher making a “reasonable request.”
Scores of personal injury and product liability lawsuits have featured in recent years that help explain Godlee’s rationale. Drug manufacturers have paid out many billions of dollars in settlements after being embroiled in litigation concerning the dangerous side effects of drugs across a wide spectrum, with charges often centering on manufacturers’ misleading statements or withholding of adverse clinical information. Doctors and clinics have also been sued for medical malpractice in such matters.
The hope is that greater patient safety will ensue from the increased transparency resulting from such a demand, with drug makers knowing that independent researchers will have access to and be able to test relevant data.
“I think that’s a very powerful and important step,” said one researcher.
It is unclear whether other widely-read journals will follow suit. A spokesperson for The Journal of the American Medical Association merely noted in response to the news that there are various ways of addressing the issue. The New England Journal of Medicine stated that it does not comment on other publications’ policies.
Understandably, PhRMA — a major lobbyist for the drug industry — was less than enthused by the announcement. An executive of the trade group stated that the journal’s new dictate could compromise patient confidentiality and also undermine medical advances by increasing the likelihood for competitive rivals to access a company’s proprietary data.
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Source: New York Times, “Medical journal to require more details on drug trials,” Katie Thomas, Oct. 31, 2012