FDA Proposal on Journal Reprints Draws Fire
The Food and Drug Administration wants to give drug and medical device manufacturers the right to distribute medical journal reprints touting the off-label use of products without prior FDA approval. According to the proposed guidelines, drug-industry salespersons would be able to hand out medical journal articles to doctors that discuss alternative uses of drugs or devices that have not been approved by the FDA or adequately tested by their manufacturers. The proposed guidelines also do not require that the studies reported in the reprints include randomized, controlled clinical trials, long considered the gold standard of medical research.
Under previous regulations, which lapsed in 2006, drug makers could only distribute published scientific studies if they gave copies to the FDA beforehand and had sought approval from the agency for the off-label use discussed in the study. Neither condition was included in the new proposed guidelines, although only articles that had appeared in peer-reviewed journals with conflict-of-interest disclosure policies could be distributed. That didn’t mollify Rep. Henry Waxman (D-CA), who charged "it's a conflict of interest for the company to be promoting sales when they haven't been able to establish that a drug is safe and effective through the rigorous FDA process."
Conservation groups charge that the new plans regurgitate proposals touted by the Off-label uses are a major component of drug sales and now account for 21 percent of all doctor-written prescriptions, according to a 2006 study published in the Archives of Internal Medicine (subscription required). Some researchers fear adoption of the proposal will encourage drug companies to cut back on testing drugs with large off-label sales. “Companies could openly promote products for unapproved indications without testing these drugs,” said Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. “I’m astonished that this rule would even be considered.” The public has until April 15 to comment.
Rx Companies See Publishing as Marketing Strategy
Most of the country’s leading pharmaceutical companies see publishing clinical trials results as a marketing tool as well as a method of disseminating scientific information about its drugs, a new industry survey showed. The report, “Scientific Publications Strategy: Managing Reputation, Clinical Trial Results, and Commercial Relevance” by Best Practices LLC, surveyed scientific directors at 14 leading pharmaceutical companies including GlaxoSmithKline, Pfizer, Bristol-Myers Squibb, Abbott Laboratories, Amgen, Merck, Genentech and Eli Lilly. Eight of the firms included regional or national marketing managers on teams planning their publications strategy. “Scientific publications are an essential tool for both clinical and commercial purposes, as they are intended to influence the target audience by raising both awareness of the disease and awareness of a company’s product,” the report stated.
Wolf Delisting Called Premature
The Bush administration last week announced an end to federal Endangered Species Act protection for the Northern Rocky Mountain population of gray wolves, saying that the wolves had recovered adequately to survive without federal protection. The move strips federal protections from wolves throughout the states of Wyoming, Idaho, and Montana and portions of Utah, Oregon, and Washington; the Center for Biological Diversity says that state officials from Idaho and Wyoming have announced intentions to kill or allow for the hunting of approximately half their wolf populations. A coalition of environmental groups has announced plans to sue over the decision, saying that scientists are in agreement that the existing wolf population is too small to allow for full recovery. The livestock industry and state officials have opposed federal protections for wolves, although a majority of local residents expressed opposition to state plans to increase wolf hunting.
Science Scandal Rocks Indian University
A chemist in India plagiarized or falsified more than 70 research papers published in 25 research journals over three years, according to documents obtained by his university. An investigation by Sri Venkateswara University in Tirupati, India, found that chemistry professor Pattium Chiranjeevi from 2004 to 2007 published scores of papers that plagiarized other researchers’ work and lifted statements from his own previous articles. The papers, which included a submission on measurement of arsenic that was nearly identical to a published paper on the measurement of chromium, were published in numerous journals, including five run by the scientific publishing powerhouse Elsevier. A majority of the papers have been retracted. Gary Christian, editor-in-chief of Talanta, an analytical-chemistry journal, said the editors and reviewers are overwhelmed and cannot catch all instances of plagiarism. A spokesperson of Venkateswara University says that Chiranjeevi retains his teaching position but has been barred from research and from holding administrative positions. "The chemistry in most of his papers is illogical—the chemistry itself is wrong,” said the spokesperson. “How did this get past reviewers?”
Odds and Ends
Representative Rosa DeLauro (D-CT), chairwoman of the House Appropriations Subcommittee on Agriculture, is calling for an independent agency outside the Department of Agriculture to carry out food safety inspections in the wake of a Humane Society invesitgation that found mistreatment and inclusion in the food supply of sick cows at a Southern California slaughterhouse. DeLauro said that the Agriculture Department’s responsibility to ensure food safety was incompatible with its role of promoting the U.S. beef industry.
Cheers and Jeers