Medical Journal’s Article Raises Conflict Concerns
The current New England Journal of Medicine--one of the world’s top outlets of clinical information--carries a favorable article on two popular hair-loss treatments without disclosing the author’s financial ties to the companies that make the drugs.
Publication of the article, by Dr. Vera Price, a UC San Francisco professor of clinical dermatology, raises questions about the journal’s monitoring of potential conflicts of interest.
Price’s article concluded that the “treatment of hair loss has been advanced” by the drugs Rogaine and Propecia. She has served as a paid consultant to the drugs’ makers, which also have funded her lab to test the drugs on people, she said last week when asked by The Times if she had ties to the companies.
Given those financial ties, her article apparently broke the journal’s unusually stringent guidelines. The journal “prohibits editorialists and authors of review articles from having any financial connection with a company that benefits from a drug or device discussed in the editorial or review article,” the guidelines say. Among those connections are “consultancies” and “major research support.”
The journal’s editor in chief, Dr. Marcia Angell, said Price had signed a form before publication disavowing such conflicts of interest. “We’re looking into it,” Angell said Monday.
Price disputed the contention that she withheld any financial information from the journal, and expressed dismay that it was even an issue. “I certainly disclosed everything to the New England Journal,” she said in an interview. The journal, she said, “made it very clear that there was no conflict of interest.”
The incident may be more than just an internal editorial squabble, given the journal’s preeminence and great influence, the drugs’ immense market, Price’s reputation as a leading expert, and the growing academic concern over financial conflicts of interest in clinical research and practice.
“Conflicts of interest in biomedical research are rising,” said Sheldon Krimsky, a Tufts University professor of environmental policy who has studied journals’ conflict-of-interest policies. “There’s a lot more commingling of science with business than there was 15 or 20 years ago and it’s happening on a larger scale.”
Price said she stopped consulting for the companies a year ago when the journal invited her to write the article. She added that she expected to resume the consulting now that it has been published. Still, the agreement that she allegedly signed also barred “planned future financial associations.”
Meanwhile, she said, she continued to receive research funding from the companies to do clinical studies. That too would appear to disqualify her from writing a review article for the journal.
She told The Times that she could not “guesstimate” how long she had been a consultant for Pharmacia & Upjohn Inc., which first won government approval for Rogaine in 1988, though it was a “long time.” She said she began consulting for the maker of Propecia, Merck & Co., more recently. The drug was first marketed for hair loss in 1998.
Krimsky said scholarship so far is divided on the question of whether authors with ties to companies are predisposed to treat them favorably.
But, he said, “the suspicion is that financial conflicts of interest can be a potentially biasing factor. . . . That’s why it’s wise to let investors, editors and consumers have as much information about the financial interests of the author, to make up their own minds.”
Yet some observers have said the hunt for buried financial conflicts of interest is a type of “medical McCarthyism,” as a 1993 editorial in the Journal of the American Medical Assn. said. It attacked the notion that physicians and researchers receiving company funds automatically are guilty of bias.
But leading medical journals have instituted or updated conflict-of-interest policies in recent years. They typically require that authors disclose financial ties to companies whose products are covered.
The New England Journal, ironically, goes even further. Like other journals, it allows authors of original studies to have a financial link to products like drugs, requiring only that the relationship be disclosed. But it disqualifies experts who receive substantial commercial support from writing editorials and research reviews, since those articles are freer to express personal preferences, as the journal’s guidelines explain:
“Because the essence of reviews and editorials is selection and interpretation of the literature, the Journal expects that authors of such articles will not have any financial interest in a company [or its competitor] that makes a product discussed in the article.”
The journal strengthened its policy in 1996, after being widely criticized for running an editorial by researchers who failed to divulge that they had been consultants to a company whose product was being evaluated.
Price’s article, labeled as a “review,” summarizes data on five different treatments for inherited and acquired hair loss in men and women. But most of the discussion is devoted to Rogaine, an over-the-counter topical medication, and Propecia, a prescription tablet.
The article discusses the drugs’ limits and side effects as well as emphasizing their effectiveness. The “clinical impression is that scalp coverage continues to increase” after two years in men who take Propecia, or finasteride, Price wrote. Rogaine, or minoxidil, has a “substantial growth-promoting effect.”
Pharmacia & Upjohn Inc. did not respond to questions Monday. A Merck spokesman confirmed that Price received funds to do clinical studies for the company and had been paid to give lectures to doctors.
Angell said the journal trusts what authors say about their financial arrangements, just as it has to accept that the scientific data authors provide is accurate. “In general, we trust people until we find reason to do otherwise,” she said.
“It’s our belief that the system has worked very well since it was instituted. There have been no more than a couple of violations that we know of. We have no plans at present to do anything different.”
In December 1997, Price appeared at a Merck & Co. news conference when the company won U.S. approval to market Propecia. She was quoted as saying, “This is real hair.”
