Friday, August 28, 2009



Promoting Openness, Full Disclosure, and Accountability

Until now, American medicine as a profession has turned a blind eye and deaf ear to ghostwritten journal articles that have corrupted the integrityof the medical literature, displacing science-based medicine with corporate propaganda masquerading as science.

The New York Times reports (below) that Senator Charles Grassley has setabout to put a stop to this fraudulent practice--a practice that underminesthe integrity of medical journals, and by extension, the practice of medicine. Shame on academic medicine for putting its collective head in the sand byfailing to use its professional leverage to sanction academics who abusetheir credentials--and sully the reputation of their institutions--by penning their name to ghostwritten, industry propaganda masquerading asscience.

Shame on academic medicine--including, universities, the National Institutesof Health, and medical journals--for failing to take action against doctorswho pen their name to ghostwritten articles for cash. Academic physicians who sign off on ghostwritten articles are participants in fraud, helping companies mislead practicing physicians who look to journals and academic"authorities" for guidance in their clinical practice.

How unseemly that medicine as a profession and prestigious academic institutions, the recipients of public substantial public funding, have not taken any steps to discipline faculty members who engage in scientific fraud. Evidence of the breadth of the practice has come to light only gradually, inthe process of litigation: most recently in court released documents released over hormone replacement drugs made by Wyeth. Those documents reveal that three professors who were authors of Wyeth-financed ghostwritten articles are on the faculty of Columbia University.

The three are also recipients of N.I.H. grants, according to the letter from Mr. Grassley.The Times reports that not until the universities were threatened with Congressional action--i.e., withdrawal of federal support, did they even acknowledge the issue: Universities have been slow to react to evidence about the extent of the practice.

In December, for example, Sen. Grassley released documents indicating that Design Write had drafted an article that was published underthe name of a gynecology professor at New York University School of Medicine. Eight months later, Deborah Bohren, the vice president for public affairs at New York University Langone Medical Center, said the school had not looked into the matter:"If we had received a complaint, we would have investigated. But we have not received a complaint."This attitude demonstrates the inadequacy of conflict of interest disclosure policies, underscoring the need for Congressional enforcement requirementsto prohibit conflicts of interest. It is necessary for Congress to use its persuasive leverage--the power of the purse--to restore the integrity of medicine.

Requiring disclosure alone, as bioethicist Carl Elliott, MD, observes,"allows pharmaceutical companies to launder their marketing messages." Contact: Vera Hassner

THE NEW YORK TIMESAugust 19, 2009 Senator Moves to Block Medical Ghostwriting

A growing body of evidence suggests that doctors at some of the nation's top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters workingfor drug companies - articles that were carefully calibrated to help the manufacturers sell more products.Experts in medical ethics condemn this practice as a breach of the public trust. Yet many universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account.

Those universities may not have much longer to get their houses in order before they find themselves in trouble with Washington.With a letter last week, a senator who helps oversee public funding for medical research signaled that he was running out of patience with the practice of ghostwriting.

Senator Charles E. Grassley, an Iowa Republican who has led a long-running investigation of conflicts of interest in medicine, is starting to put pressure on the National Institutes of Health to crack down on the practice.That is significant because the N.I.H., a federal agency in Bethesda, Md.,underwrites much of the country's medical research. Many of the nation's top doctors depend on federal grants to support their work, and attaching fresh conditions to those grants could be a powerful lever for enforcing new ethical guidelines on the universities.

Like many of the universities, N.I.H. appears reluctant to tackle the issue. A spokesman said the agency was committed to maintaining objectivity in science. But he added that in the case of ghostwriting allegations,universities and other institutions that employ researchers are responsible for setting and enforcing their own ethics policies."How long does it have to go on before it actually is stopped? One way to stop it would be if the actual authors were punished in some way," said Dr.Carl Elliott, a professor at the Center for Bioethics of the University of Minnesota. "But the academics who are complicit in it all never seem to bepunished at all."

The full scope of the ghostwriting problem is still unclear, but recent revelations suggest that the practice is widespread. Dozens of medical education companies across the country draft scientific papers at the behestof drug makers. And placing such papers in medical journals has become a fundamental marketing practice for most of the large pharmaceutical companies."Just three days ago, I got a request to be the author of a ghostwritten article about the effectiveness of a cholesterol-lowering drug," Dr. JamesH. Stein, professor of cardiology at the University of Wisconsin School ofMedicine, said this month. "This happens all the time."

He declined to attach his name to the paper. Allegations of industry-sponsored ghostwriting date back at least a decade,to scientific articles about fen-phen, the diet drug combination that wastaken off the market in 1997 amid concerns that it could cause heart-valve damage. But evidence of the breadth of the practice has come to light only gradually, most recently in documents released in litigation over menopause drugs made by Wyeth.

The documents offer a look at the inner workings of DesignWrite, a medical writing company hired by Wyeth to prepare an estimated 60 articles favorableto its hormone drugs. In one publication plan, for example, DesignWritewrote that the goal of the Wyeth articles was to de-emphasize the risk of breast cancer associated with hormone drugs, promote the drugs as beneficial and blunt competing drugs.

The articles were published in medical journalsbetween 1998 and 2005 - continuing even though a big federal study was suspended in 2002 after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer and heart disease. Wyeth has changed its policy in the years since the hormone papers were published, according to Douglas Petkus, a company spokesman, and now requires that scientific articles acknowledge any participation by Wyeth ora Wyeth-sponsored writer.

No comments:

Post a Comment