Healthy Skepticism Library item: 17391

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Silverman E
Acne drug article under fire Link between author, company is criticized
The Star Ledger 2002 Jan 6

Full text:

A recent journal article on a controversy over Accutane, the acne medicine blamed for numerous teenage suicides, is causing a controversy of its own.

The November article, which appeared in the Journal of the American Academy of Dermatology, concluded there’s no scientific evidence to link the best-selling drug to suicide. Dermatologists were, however, cautioned to watch patients for signs of depression.

But the article, which only reviewed existing literature, was co-authored by a psychiatrist who is also a consultant to the drug’s manufacturer, Hoffmann-La Roche Inc. And Roche financed publication by providing a grant to the magazine.

The issue highlights an ongoing debate about the marketing practices used by the pharmaceutical industry and its ability to influence physicians, especially when it comes to medicines that generate not only big bucks, but potentially serious side effects.

“There’s a growing body of literature showing the closer the financial tie to the funder of an article, the more favorable the the findings,” said Arthur Caplan, who heads the Center for Bioethics at the University of Pennsylvania. “There’s always room for interpretation, but when you have a relationship, you always tend to lean toward the positive.”

In this case, the relationship between Roche and the article’s lead author, Douglas Jacobs, a Harvard Medical School psychiatry professor, was disclosed. So was the grant given to the journal. In response to the criticism, the author, the journal editor and a Roche spokeswoman denied that the article or the financial relationships posed a problem. They also maintained the article was a legitimate way to further discussion of a complex issue.

One expert in suicide, however, criticized the arrangement because he said it unfairly obscures the need for more information about links between Accutane and suicide. In late 1999, a Food and Drug Administration advisory panel recommended further study. To date, Accutane has been associated with 138 suicides here and aboard, according to regulators.

“My concern is that doctors are going to miss the association between the author and the drug company,” said Peter Gutierrez, a Northern Illinois University psychology professor and director of the research division of the American Association of Suicidology.

“It’s a perception issue. They know there are questions about the drug and they’re worried about prescription rates,” he continued. “If I was a dermatologist and I was reading this article, I would say they’re trying to cover their butts.”

For his part, Jacobs said he reviewed all available medical literature as well as reports filed with regulators in which depression and suicide were mentioned among Accutane patients. And he reiterated his belief that there’s nothing to link Accutane to suicide.

“People are free to draw any conclusions they want about my relationship to Roche, but I was very careful in drawing my conclusions about Accutane,” said Jacobs, who also runs a nonprofit devoted to mental-health issues. “I don’t see Accutane as a contributing factor in suicide. … And I don’t see what additional research would accomplish.”

Accutane and suicide has always been a confusing topic – both the FDA and Roche say teenagers with severe acne are likely to be depressed. Roche also maintains a clear link to suicide doesn’t exist, although the Nutley company last year was required by the FDA to provide informed consent forms to patients and restrain its advertising.

The issue has plagued Roche since 1998, when a warning was required on the product label about suicide. Since then, a growing number of lawsuits has been filed by families who claim the drug hurt their children. Accutane soon faces generic competition, but the drug is still a big seller, generating $513 million in sales in first nine months of last year.

Asked about the journal article, a Roche spokeswoman, Carolyn Glynn, said “funding through educational grants from a pharmaceutical company are a valid, respected and necessary part of the scientific process.” The journal’s editor, Jeffrey Bernhard, said the article was peer-reviewed, or examined by independent experts, a standard practice. He added that he’s committed to publishing “on subjects of clinical importance to our readers that examine questions from all angles and contribute to the discussion in an ongoing way as more information becomes available.”

Ronald Wheeland, who heads the American Academy of Dermatology, supported Bernhard’s decision. And he noted that Bernhard runs the journal without interference from the association, which last year called for further study of links between Accutane and suicide. But he acknowleged the article posed a thorny issue.

“This is a very murky area,” said Wheeland. “There’s this obvious potential conflict of interest when it comes to a person who represents a company. … Could there be a subtle change in the outcome because of his position? I can’t deny it, but I doubt it. If it was so overwhelmingly positive, I’d have concern. But this was a tempered article.”

One attorney, who represents several families, sees it differently. “It’s not unusual for drug companies to hire consultants to publish studies which tend to diminish the importance of FDA warnings,” said David Affinito.

“In this way, drug companies can convey the sublime message to doctors and their patients that the drugs are safe – in spite of the warnings.”