It the latest installment of its wonderful “Side Effects” series, the Milwaukee Journal-Sentinel, in conjunction with MedPage Today, reports on yet another troubling example of how Big Pharma influences the practice of medicine in the United States.
In this case, the medical practice is the treatment of childhood acne.
It’s a sadly familiar story: A pharmaceutical company wishing to promote a new drug hires private physicians as consultants or speakers. It also gives large sums of money to either launch or support a tax-exempt advocacy organization. That organization then decides to form a committee of physicians to draft treatment guidelines on a particular medical condition — which just happens to be the condition targeted by the pharmaceutical company’s new drug. Among the physicians asked to join that committee are the company’s paid consultants.
As Journal-Sentinel reporter John Fauber points out, just such a string of events led up to last May’s endorsement by the American Academy of Pediatrics (AAP) of what it called the “first detailed, evidence-based clinical guidelines for the diagnosis and treatment of pediatric acne.”
However, nowhere in those guidelines, nor in any of the press materials released with the guidelines, writes Fauber, were these two facts made public:
- Of the 15 experts who put the guidelines together, 13 had received consulting or speaking fees by the companies that made the drugs.
- The organization — the American Acne and Rosacea Society — that developed the guidelines and that paid to publish them as a supplement to the AAP’s journal, Pediatrics, received 98 percent of its 2011 revenue from the companies that made the drugs.
Indeed, the co-chairs of the committee that put together the guidelines, Dr. Diane Thiboutot, professor of dermatology at Penn State-Hersey, and Dr. Lawrence Eichenfield, pediatric dermatologist at the University of California, San Diego, have both been paid consultants for Galderma Laboratories, which makes the anti-acne medication Epiduo gel.
They are also the president (Thiboutot) and president-elect (Eichenfield) of the American Acne and Rosacea Society.
In an interview with Fauber, Eichenfield insisted that the process of putting together the guidelines was “fair and balanced” and that the results were not influenced at all by drug company money.
The appearance of conflict of interest is certainly there, however. The drugs that received the highest recommendations in the guidelines were combination prescription drugs (ones containing two agents). As Fauber notes, those drugs “can run up to $2,500 a year for treating acne. In contrast, benzoyl peroxide, an effective over-the-counter product that is a primary component in some of the drugs, costs less than $120 a year.”
Galderma’s drug, Epiduo, which combines benzoyl peroxide with a prescription retinoid-like compound, adapalene, was one of the guidelines’ highest-ranking drugs.
“In general, research involving Epiduo shows it is somewhat more effective in treating mild to moderate non-inflammatory acne than either of its component alone, according to a 2011 review published in American Family Physician,” writes Fauber. “However, the paper said that three clinical trials of the product showed only a 10% to 15% improvement.”
“The same paper noted that its cost is much higher than individual components sold separately,” he adds, “and that patients should start with less expensive options and use the more expensive combinations only if the initial treatments don’t work.”
Another product that got high marks in the guidelines was Acanya, which combines benzoyl peroxide with a topical antibiotic, clindamycin gel.
“If those two components were bought separately, the cost would be less than $140 for two months, or $840 a year,” writes Fauber.
That’s much less than the cost of Acanya: $426 for two months, or $2,500 per year.
Acanya is marketed by the Medicis division of Valeant Pharmaceuticals. Eight of the 13 members of the guidelines committee — including Thiboutot and Eichenfield — worked as consultants for that company between 2008 and March 2013, reports Fauber.
A lack of full disclosure
Other eyebrow-raising elements of this story include the following:
- Although the AAP has a policy about reporting conflicts of interests, it did not do so when it endorsed and published the acne guidelines last May. The academy refused to tell Fauber how much it was paid by the Acne and Rosacea Society to published the guidelines or how much money it has received from acne drug companies.
- Eichenfield has been quoted saying positive things about Epiduo in press releases written and distributed by Galderma. But nowhere is it mentioned in those releases that he has been a paid consultant to the company.
- A New Jersey company, Physician Resources LLC, provided editorial and research assistance to the committee of physicians that developed the guidelines. The company refused to discuss with Fauber its business relationship with Galderma or any other drug company. However, reports Fauber, in the past Physician Resources has helped Galderma arrange at least one free steak-and-lobster dinner talk for doctors — a talk that was about Epiduo.
You can read Fauber’s article on the Journal Sentinel website.