A Classic Example of Medical Journal Manipulation by Pharmaceutical Industry?
In the August 4, 2005 edition of the New England Journal Of Medicine, an editorial piece seems to cast some doubt on a research study report appearing in the same publication. By chance, this might be the classic example of medical journal manipulation which was discussed in my recent post about Big Pharma and major medical journals.
Provigil (modafinil), by Cephalon Inc., is an effective drug used by nighttime employees to improve their alertness and performance, according to the study's lead author, Charles A. Czeisler, chief of the sleep medicine division at Harvard Medical School as well as at Brigham and Women's Hospital, in Boston. Interestingly, Dr. Czeisler's professorship is endowed by Cephalon for $2 million. Moreover, Dr. Czeisler's new study was funded by Cephalon, Provigil's manufacturer, also.
In comparison, Dr. Cziesler's research failed to impress the author of a biting editorial in the same edition of the New England Journal of Medicine (NEJM), who said the data developed and presented by Dr. Cziesler suggests that Provigil is "little better than nothing."
According to an August 4, 2005 report in the Wall Street Journal (WSJ) about this rather unusual situation, Provigil was first approved by the FDA in 1998, for use to treat excessive sleepiness. In 2003 the FDA approved Provigil for the treatment of "shift-work sleep disorder". About 5% to 10% of the estimated six million people in the U.S. who work at night reportedly complain of shift-work sleep disorder, the symptoms of which are daytime insomnia, or excessive sleepiness for people working a night shift. In 2004 U.S. doctors wrote 1.9 million prescriptions for Provigil, generating $414 million in sales for Cephalon. In the August 4 article, WSJ reporter Suzanne Sataline isolates the issue: "The debate within the pages of the prestigious medical journal raises renewed questions over the reliability of research sponsored by drug companies."
Against this background, we take a quick look at this odd NEJM "internal" debate.
Dr. Czeisler contends that workers taking Provigil were more awake and had a decline in drive-time accidents or near-misses. "I would characterize [Provigil] as the treatment of choice with patients with shift-work disorder," Dr. Czeisler said in his NEJM study report.
On the other side is Robert C. Basner, director of Columbia University's Cardiopulmonary Sleep and Ventilatory Disorders Center. Dr. Basner is the author of the NEJM editorial about the Provigil study. In his opinion, the researchers' data showed only slight improvements in workers wakefulness and productivity; further, Provigil seemed to exacerbate insomnia for some patients. "That's not a very robust endorsement of the drug coming from the investigators themselves," said Dr. Basner, "This drug is little better than nothing in terms of making them less sleepy during shift work at night."
There should be some interesting letters to the editor in upcoming editions of the NEJM about this apparent controversy concerning the efficacy of Provigil, and probably much more.
(Posted by: Tom Lamb)