I have always wondered why doctors/dermatologist just keep doing the same old protocol of antibiotics, topical retinoids and/or isotretinion (aka Accutane) that does not work for most acne sufferers. Well, seems like they are being paid off by the drug companies… surprise, surprise….. And no, I am not making this up.
Teens and their parents are familiar with the marketing blitz around expensive new prescription drugs for acne, with TV ads urging viewers to “blame biology” for their outbreaks and to then “call your doc” to get help.
But those doctors have not gotten the whole story.
When the American Academy of Pediatrics endorsed guidelines that recommend the drugs to treat childhood acne, it didn’t tell doctors this: 13 of the 15 experts who drafted the guidelines were paid consultants or speakers for companies that make the drugs.
Or this: The organization that developed the guidelines — and paid the academy to publish them as a supplement to its medical journal, Pediatrics — received 98% of its 2011 revenue from companies that make acne drugs.
The acne guidelines are an example of how drug companies wield a powerful influence over the practice of American medicine, but with a twist: A review by the Journal Sentinel/MedPage Today shows little separation between the guidelines, the doctors involved and the marketing blitz that followed.
“Does it make me suspicious? Are you kidding?” asked Catherine DeAngelis, a professor of pediatrics at Johns Hopkins School of Medicine and former editor of the Journal of the American Medical Association.
“The basis for these guidelines seems to be marketing, not science.”
The market — mainly teens and their parents — is a lucrative one. In 2012, the top five prescription acne drugs alone tallied $1 billion in U.S. sales, according to the drug-market research firm IMS Health.
A Journal Sentinel/MedPage Today investigation in 2012 found that treatment guidelines related to the nation’s 25 top-selling drugs were heavily stacked with doctors who had ties to drug companies. In some instances, the guideline panels promoted expensive brand name drugs made by those same companies and made dangerous or ineffective treatment recommendations.
Of the 16 guideline panels that disclosed conflicts of interest, 164 of 247 doctors — 66% — had financial ties to drug companies, the 2012 analysis found.
In this case, the acne guidelines were produced by the American Acne and Rosacea Society, which received $528,000 of its $541,000in revenue in 2011 from companies that make acne drugs, according to tax records it must file with the IRS to maintain its tax-exempt status.
The guidelines recommend the use of combination drugs — ones that involve two agents — that 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.
One company, Galderma Laboratories, was especially close to the process. It is the maker of Epiduo, which is featured in an ad campaign urging teens to give up on other treatments in favor of an “Epi-do-over.”
The company gave $176,000 to the acne society in 2011, the largest contributor that year. Both Galderma and the society declined to say how much money the company gave last year. However, Galderma is listed as a “diamond benefactor” on the society’s website, meaning it gave at least $75,000.
The co-chairs of the acne guidelines panel — Diane Thiboutot, professor of dermatology at Penn State-Hershey; and Lawrence Eichenfield, pediatric dermatologist at the University of California, San Diego School of Medicine — have worked as consultants or speakers for Galderma.
Both are also top officers of the acne society, which convened the panel — Thiboutot is president, Eichenfield is president-elect.
Indeed, 13 of the 15 doctors on the panel — 87% — had financial ties to Galderma, according to disclosure forms provided to the Journal Sentinel/MedPage Today by the American Academy of Pediatrics. Those financial relationships occurred between 2008 and 2013, though the forms did not specify how long the relationships lasted or how much they were paid.
One of the 13 noted that his work on the guidelines was done before Galderma engaged him as a consultant, thoughhe worked for the company before the guidelines were published.
When the guidelines were published in May, Epiduo and other topical products that combine two acne-fighting agents received the panel’s highest recommendation for use on adolescents. They cited the convenience of only having to apply it once a day — the same pitch highlighted in the TV ads.
Epiduo combines benzoyl peroxide with a prescription product, adapalene. At Walgreen’s it has retail price of $332 for a 45 gram supply, which can last three months, or $1,300 a year. That is the price for someone without insurance paying with cash. In contrast, benzoyl peroxide costs less than $30 for three months.
Three months before the guidelines were published, Galderma had won U.S. Food and Drug Administration approval for using Epiduo to treat children from ages 9 to 11. At the time, the company’s news release announcing the approval quoted Eichenfield saying that pediatricians and dermatologists now have a safe and effective treatment for children with early acne.
He was quoted again in July, two months after the guidelines were published, when Galderma released a national survey of mothers and their attitudes about treating acne. Neither of the releases noted he has been a paid consultant to the company.
In August, the company paid to include an ad for Epiduo and a wall chart explaining the new guidelines in the American Academy of Pediatrics’ news magazine, AAP News. The trade publication, which is separate from the academy’s scientific journal, goes to 60,000 pediatricians and other medical professionals.
Warren Winkelman, director of medical affairs for Galderma, said it was understandable to question whether the guidelines and other promotions were tied together as part of a big marketing plan.
But he said that the company did not have any involvement in the content or recommendations in the guidelines, which he called “evidence-based and scientifically sound.”
“We felt it was a good thing for patients,” he said.
In general, research involving Epiduo shows it is somewhat more effective in treating mild to moderate non-inflammatory acne than either of its components alone, according to a 2011 review published in American Family Physician. 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 and that patients should start with less expensive options and use the more expensive combinations only if the initial treatments don’t work.
Eichenfield, the guideline co-chairman, said the panel used rigorous science to make its recommendations and that drug company money had no influence on the panel’s findings.
Calling the guideline process fair and balanced, he said he tried to avoid conflicts by making sure that at least one of the two panel members heading up each section of the guidelines did not have a financial relationship with an acne drug company at the time of the review process.
“It would be a shame for these guidelines to be thought of as being tainted by pharmaceutical money when I feel that they weren’t,” Eichenfield said.
Asked about being quoted in two news releases from Galderma, Eichenfield said he does not endorse any acne product and he is not a spokesman for the company.
The guidelines did not meet conflict of interest standards created in March 2011 by the Institute of Medicine, the health arm of the National Academy of Sciences.
Those standards say guideline-writing committees should not have a majority of doctors with financial relationships with drug companies. They also say committee chairs should not have financial conflicts of interest.
When asked why the panels didn’t meet the Institute of Medicine’s standards, Eichenfield said the standards were not in place when the guideline process was begun.
The American Academy of Pediatrics has a policy of disclosing conflicts of interest, but did not do so in this case of the acne guidelines.
In response to a request to see the disclosure statements, academy spokeswoman Debbie Jacobson at first said the Journal Sentinel/MedPage Today would have to obtain permission from each of the authors. She later sent out permission requests to the authors.
The academy later provided the disclosure forms to the Journal Sentinel/MedPage Today.
Jacobson wouldn’t say how much the academy was paid by the acne society to publish the guidelines or how much money it has received from acne drug companies; Galderma paid to distribute its marketing poster with the magazine.
She referred questions to the acne society. Eichenfield said there was no attempt to keep the documents secret. He said he thought the academy, which provided experts to review the guidelines before they were published, was going to list the disclosures.
As of Sept. 13, the conflict of interest disclosures had not been added to the guidelines online.
A reference in the published guidelines notes a New Jersey firm, Physician Resources LLC, provided editorial and research assistance. Company CEO Stacey Moore declined to discuss the firm’s business relationship with Galderma or any other drug companies.
Physician Resources works with the drug industry to arrange for doctors and key opinion leaders to provide talks to other doctors. For instance, the firm served as the meeting coordinator for Galderma for a free dinner talk for doctors in July at a steak and lobster restaurant in Orlando.
The subject of the talk: learning more about Epiduo.
Other product ties
In addition to the ties with Galderma, eight of the 13 panel members — including both co-chairs — worked as consultants or speakers for Valeant Pharmaceuticals at some point between 2008 and March 2013.
Valeant is listed as a current diamond benefactor to the acne society, meaning it gave at least $75,000.
The company’s Medicis division, acquired in 2012, markets the prescription acne product Ziana, which also got the top recommendation from the guidelines panel. That product has a Walgreen’s cash price of $743 for 60 grams, which is supposed to last four months, or $2,200 for a year.
The division also markets Acanya, another combination product mentioned in the guidelines. It has a cash price of $426 for 50 grams, which lasts two months, or $2,500 for a year.
That product combines benzoyl peroxide with the 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.
The guidelines give a special nod to combination products, saying that even though they may cost more than single agents applied separately they are “very convenient” and such convenience may improve how well patients use the products, known as adherence.
As proof, the guidelines cite a 12-week clinical trial that showed better adherence with a combination product than when its two ingredients are applied separately at different times.
But the trial was very small — only 21 out of 26 people completed it — and two of the key findings, including overall adherence, were not statistically significant. In addition, the study was funded by Medicis, whose product was used in the trial.
Independent doctors said that while the combination products may be more convenient, cost also can be an important factor in determining whether a child continues to use a product as directed, especially when treating mild acne.
For those who have prescription insurance coverage without high deductibles, the cost of the recommended products may be acceptable, the doctors said. But for others, it can be a barrier.
Valerie Lyon, a pediatric dermatologist with Madison Medical Affiliates, which is part of Columbia St. Mary’s Health System, said the products are effective but the guidelines could have done more to compare costs of the various treatment options.
She said she always asks parents about their ability to afford a treatment option. Often, she finds that the combination products are too expensive.
“When you are talking about treating somebody, that’s really what matters,” she said.
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