A report was issued in last weeks' NEJM: "Safer Drugs for the American People" that may be of interest...but first, some introductory information regarding the primary source of evidence, The New England Journal of Medicine:
New England Journal of Medicine
The New England Journal of Medicine (New Engl J Med or NEJM) is a peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. It is also the oldest continuously published medical journal in the world.
It was founded by Dr. John Collins Warren in 1812 as a quarterly called The New England Journal of Medicine and Surgery. In 1828, it became a weekly, and was renamed The Boston Medical and Surgical Journal; one hundred years later, it took on its present name.
It publishes editorials, papers on original research, widely-cited review articles, correspondences, case reports, and has a special section called "Images in Clinical Medicine".
Authors have included Oliver Wendell Holmes, Sr., Hans Zinsser, and Lewis Thomas. One of its early editors, Jerome V. C. Smith, resigned in 1857 to assume his duties as mayor of the City of Boston.
The website for the George Polk Awards noted that its 1977 award to the New England Journal of Medicine "provided the first significant mainstream visibility for a publication that would achieve enormous attention and prestige in the ensuing decades"[1]
The journal usually has the highest impact factor of the journals of clinical medicine (including the Journal of the American Medical Association, and The Lancet); in 2006, the impact factor was 51, according to Journal Citation Reports, the first research journal to break 50.
1. ^ http://www.brooklyn....lk/history.html
Here is the abstract:
Published at www.nejm.org July 18, 2007 (10.1056/NEJMe078154)
Safer Drugs for the American People
Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.
By wide margins, both the House and the Senate have now passed bills that aim to ensure the safety of the drug supply in the United States.1,2 Given the serious safety problems that have arisen with drugs taken by millions of Americans, this legislation is long overdue. It is now up to both houses of Congress to resolve the differences between the two versions and agree on a strong final bill to send to the President.
This year, Congress had to consider reauthorization of the Prescription Drug User Fee Act (PDUFA), which it must do every 5 years. Under PDUFA, the major funding for the review of new drugs by the Food and Drug Administration (FDA) comes from user fees paid by pharmaceutical companies. This mechanism has been controversial because, although it was designed to accelerate the drug-approval process and can make new drugs available to patients without delay, it has directed no money to the postmarketing assessment of drug safety. In addition, some believe that user fees pose a conflict of interest for the FDA. Nonetheless, to ensure that the FDA has adequate financial resources, both the House and the Senate versions of the bill not only maintain these user fees but increase them (with some of the money now directed to safety assessment).
In reauthorizing PDUFA, Congress has wisely taken the opportunity to strengthen the FDA's authority over drug safety, and both versions of the bill give the FDA new tools to accomplish this objective. At a minimum, we believe that the final bill should contain the following essential components.
The FDA must have the authority to mandate adequately powered postmarketing clinical trials of the safety of approved drugs and to require specific timetables for their completion and reporting of results.
The FDA must also have the authority to conduct an annual review of drug safety for the first 3 years after a drug's approval and again at 7 years.
To assist patients in reporting adverse effects of the drugs they are taking, drug advertisements and labels must include a toll-free telephone number and a Web address.
There must be substantial penalties for drug advertising that overstates efficacy or understates adverse effects.
The FDA must be able to mandate changes to drug labels as new information about safety and efficacy becomes available.
In order to provide safety surveillance, every new drug should have a pharmacovigilance plan at the time of its approval. Sophisticated pharmacoepidemiologic surveillance systems must be created to allow the FDA to monitor reports of adverse drug effects in large databases.
Clinical trials of drugs must be registered in a public database.
In the wake of the landmark report on drug safety issued by the Institute of Medicine almost a year ago,3 Congress is now poised to pass the most important drug-safety legislation in a century. Although we remain concerned about the user-fee approach to funding of the FDA, we believe that the bills initiated by Congressmen Henry Waxman and Edward Markey and by Senators Edward Kennedy and Michael Enzi are important steps in the right direction. Congress should now speedily agree on a substantive drug-safety bill and give the FDA the tools it needs to do its work. The crisis of confidence in the nation's drug supply must be resolved.
Source Information
This article (10.1056/NEJMe078154) was published at www.nejm.org on July 18, 2007. It will appear in the August 9 issue of the Journal.
References
1. H.R. 2900, 110th Cong. (2007).
2. S. 1082, 110th Cong., 1st Sess. (2007).
3. Committee on the Assessment of the US Drug Safety System, Baciu A, Stratton K, Burke SP, eds. The future of drug safety: promoting and protecting the health of the public. Washington, DC: National Academies Press, 2006. (Available at http://www.iom.edu/C...41/37329.aspx.)
