Study In NEJM Details How Drug Companies "Hide" Critical Information
A study published in the December 29, 2005 New England Journal of Medicine (NEJM), "Trial Registration at ClinicalTrials.gov between May and October 2005", discusses how some major drug companies are continuing to withhold important information about their clinical drug trials.
The NEJM-published study is written by National Institutes of Health staffers (Deborah A. Zarin, M.D., Tony Tse, Ph.D., and Nicholas C. Ide, M.S.) associated with the federal web site, www.ClinicalTrials.gov . The authors assert that some drug companies -- such as Merck & Co., Pfizer Inc., and GlaxoSmithKline PLC -- are not disclosing or obscuring critical information about their clinical trials that have been registered on this federal site. Examples mentioned in the study include the omission of the most basic type of information, like the very names of some drugs which are the subject of these clinical trials.
As background, some drug companies have routinely kept secret the results of clinical studies that reflected badly on their drugs, but published widely those studies which attained positive results for their drugs. The federal ClinicalTrials.com site for reporting on clinical trials was created in 2002 to be a publicly accessible registry of clinical trials of prescription drugs and medical devices designed to treat serious or life-threatening diseases and conditions. As mandated by Congress, the drug and device companies are allowed to register trials on this federal web site only if the companies provide certain required information.
This December 2005 NEJM article includes assertions that several large companies are providing information that is incomplete or vague. As mentioned above, some drug companies do not disclose the name of the drug which is the subject of their registered clinical study. Instead, when completing a data field for the drug name, a company will use an obscure phrase such as "investigational drug."
In a December 29, 2005 Wall Street Journal article, Jeffrey M. Drazen, editor in chief of NEJM, commented that the current federal requirements had a critical "loophole" by not requiring companies to specifically name the drugs being tested. Further, Dr. Drazen observed, by obscuring such basic information these drug companies "are meeting the letter but not the spirit of the law".
An editorial by Dr. Drazin in the December 29, 2005 edition of the NEJM called for medical researchers and potential patient-subjects to avoid participating in clinical trials where the drug company takes such a secretive approach. Dr. Drazen wrote that it "makes moral sense" to provide complete trial information, adding:
"When patients put themselves at risk to participate in clinical trials, they do so with tacit understanding that their risk is part of the public record, not merely the secret record of the sponsor."
Note: The full text of the December 29, 2005 NEJM article about this ClinicalTrials.gov study is being made available for free by the medical journal to non-subscribers as a public service.
(Posted by: Tom Lamb)