Legislative scrutiny on drug marketing--which has only intensified as Congress debates the reauthorization of the Prescription Drug User Fee Act--has zeroed in on medical education.

A recent report from the Senate Committee on Finance concludes that while drug makers have taken steps to separate their education and marketing efforts, companies still exert "too much influence" over the content of industry-funded continuing medical education (CME). And one drug maker, Eli Lilly, has already announced that it will make its process for awarding educational grants more transparent.

The Senate report found that over the past two years, 24 percent of CME providers did not comply with policies designed to limit pharma's influence on physician education. In addition, there is little incentive to follow the rules--it can take up to nine years for non-compliant programs to lose their standing with the Accreditation Council for Continuing Medical Education (ACCME).

Yet the report also commended pharma on recent moves to raise a wall between its educational and promotional efforts. While drug makers once put marketing departments in charge of awarding CME grants, medical-affairs teams now hold those reins. "The committee staff found some promising trends in pharmaceutical manufacturers' use of educational grants, but risks remain for fraud and abuse in several areas," the report stated.

Starting in June 2005, senators Max Baucus (D-MT) and Charles Grassley (R-IA) asked the 23 largest pharma firms to provide information about their educational grants programs. It also reviewed information from ACCME, peer-reviewed medical journals, and the mainstream media.

"The documents provided by the pharmaceutical companies do not reveal an explicit agreement that the CME program will favorably discuss a company product or an off-label use of a company product," the report noted. "However, it is possible that both parties reasonably expect that to be the result."

That unspoken quid pro quo, the report continues, likely hinges on the sheer amount of money that drug makers pour into CME grants. In 2005, the largest companies doled out $1.12 billion, or 75 percent of their total spending on educational grants, on ACCME-accredited programs--courses that physicians must take each year in order to stay licensed. Oncology, cardiology, and neurology/psychiatry programs nabbed the biggest industry bucks.

"It seems unlikely that this sophisticated industry would spend such large sums on an enterprise but for the expectation that the expenditures will be recouped by increased sales," the report stated. It goes on to suggest that FDA might have a role in regulating CME, just as it monitors direct-to-consumer advertising.

In response to the April 25 report, Lilly last week became the first drug maker to begin posting all of its educational grants online, at Web site www.lillygrantoffice.com. The grants fund educational programs developed by medical societies, academic centers, patient groups, and nonprofit organizations.

Legislators aren't the only ones skeptical about pharma grants. An online poll from Envision Solutions, a marketing-communications consulting firm, found that 43 percent of consumers believe that drug makers fund educational programs in order to increase sales.

Articles

Senate report suggests drug makers have too much influence on CME content.

Pharma's Med Ed Gets Low Grade From Congress

Allergan is teaming up with actress Virginia Madsen to smooth out the wrinkles that have developed in consumer awareness of its iconic line reducer Botox and Juvederm, a dermal filler.

More people are considering cosmetic injections--about 40 percent of women and 25 percent of men, according to Allergan--and the company is trying to make sure that they're pursuing the treatments from licensed physicians. "I've challenged the notion that [Botox parties are] better for business," said Robert Grant, president of Allergan Medical, who noted that business grows through positive word of mouth. "Our greatest concern is patient outcomes and patient safety. We need to maintain our sacred trust with patients."

Madsen--who was nominated for an Oscar for her role in 

--and her mother, Elaine Madsen, were dubbed spokeswomen because they have been particularly forthcoming about their use of Allergan's products. "We knew from our own experience that there were serious gaps in the information available to women and men about these treatments," said Virginia Madsen, who was in New York with her mom yesterday to kick off Allergan's "Keep the Wisdom, Lose the Lines" campaign. "They're prescription medicines. I think a lot of people have lost sight of that with the growing popularity of these products."

Allergan has also launched a parallel ad campaign with print ads in magazines like 

 to address other concerns women have. The company's "Freedom of Expression" campaign addresses the fear that Botox can lead to a "frozen" facial expression. Juvederm is being promoted with the tagline "Parentheses have a place, just not on your face," to address the fact that Botox treats lines in the upper third of the face, while Juvederm fills wrinkles and folds in the lower two-thirds. Ad agency Grey Healthcare created the spots.

The effort follows Allergan's January acquisition of Groupe Corneal Laboratoires and its portfolio of facial aesthetic products, including worldwide rights to Juvederm.

With its market share at 19 percent, Allergan is playing catch-up with Medicis, which has captured the category through sales of its dermal fillers Restylane and Perlane. Allergan is promoting Juvederm as a gel that has a smoother consistency than the more granular Restylane.

As part of the campaign, Allergan has also released a survey of the "top 10 questions" women have about cosmetic injectables--partnering with Harris Interactive and the National Women's Health Resource Center. One finding: 80 percent of women do not know the difference between Botox, made from a botulinum toxin, and dermal fillers, which are natural or synthetic fatlike substances.

The facial aesthetic market is projected to grow 25 percent over the next year and could reach $1.5 billion in 2011, according to the Millennium Research Group. Dermal fillers, which are the third most common in-office cosmetic procedure after Botox and electronic hair removal, are valued at $480 million and growing 19 percent per year.

Grant noted that only three percent of women who can afford Botox are opting for the procedure--an estimated one million out of 27 million. "It's not just about Hollywood--it's about Peoria, and that's what we're trying to penetrate into now," Grant said. Botox had total sales of $982.2 million last year, an 18 percent increase over 2005. Botox Cosmetic represents 48 percent of sales.

Allergan launches celebrity campaign for Botox and Juvederm.

Pharmaceutical Executive-05-09-2007

Pharma's Med Ed Gets Low Grade From Congress

A New Face in the Anti-Wrinkle Wars