Myth: CME isn’t influenced by commercial sponsors

“When a drug company wants to sell a pill to a doctor, its best salesperson is usually another

doctor.” (NPR reporter)

Rick Deyo

U.S. Senate Finance Committee Report - April, 2007

• “Drug companies routinely fund educational grants to support programs that favorably discuss the companies’ newer and more lucrative products, thereby encouraging physicians to prescribe those products and, ultimately, driving sales”

• In 2004, commercial support of CME exceeded $1 billion

• All 23 drug companies surveyed funded educational grants

More from Senate Finance Committee

• FDA prohibits promotion of off-label uses by entities involved in manufacture & sale; no jurisdiction over favorable discussions of a product, including off-label uses, by individuals independent of manufacturer

• Beyond guidance, FDA does little to ensure educational grant used for bona fide purposes; no system to monitor educational programs

Accreditation Council for CME (ACCME)

• Reviewed 76 accredited CME providers for compliance with standards; 24% were not compliant. Relies on self-report. Examples:

• Commercial interest influences where and how many presentations scheduled for 3 years.

• Commercial interest involved in selection of faculty and other activities

• Agreements for commercial support signed after the CME activity (contrary to policy)

• One activity contained recurring use of company's product trade name at exclusion of other products

More from Finance Committee Report

• “…unlikely that this sophisticated industry would spend such large sums… but for the expectation that the expenditures would be recouped by increased sales.”

• “…difficult to quantify the risk of kickbacks related to industry-sponsored education where companies overpay high-prescribing physicians as “consultants or “speakers” for minimal work to develop educational material or teach at educational programs”

Finance committee report• Information presented often encourages physicians to change

their prescribing practices to favor certain drugs. When the favorable message is delivered in the context of education – even if corporate sponsorship is disclosed – there is an imprimatur of credibility and independence.

• Off-label promotion risk poses greatest threat to Federal health care programs and beneficiaries… also the most difficult to demonstrate conclusively

Example: the Marketing of Neurontin

• Parke-Davis business plan: “Medical education drives this market!!”

• Educational teleconferences: goal to increase Neurontin new prescriptions; company helped establish agenda, surreptitiously monitored teleconferences in progress. Moderators paid directly by Parke-Davis

• Speakers Bureaus: Sales staff encouraged to expand the speaker base – identify and train Neurontin advocates. Lecture series to improve PR within the neurology community

Neurontin: “Unrestricted Educational Grants”

• Most grants to Medical educ. and communication companies. Same companies worked for Parke-Davis in organizing teleconferences, coordinating advisory boards and consultants meetings, tactical planning for promoting gabapentin: incentives to be consistent with P-D’s marketing goals

• One memo recommended: “assist in organization of (major university hospital's) pain symposium… we will probably write an unrestricted educ. grant… in return, they will discuss the role of Neurontin in neuropathic pain, among other topics. They do have a very favorable outlook toward Neurontin”

Marketing Plan for NeurontinActivities with clear promotional intent: Territory manager activities Journal Ads

Activities with mixed promotional intent: Patent education/support Medical liaisons Directly sponsored CME (speakers bureau, dinner meetings, teleconferences)Advisory boards/consultants mtgs.

Activities with hidden promotional intent: Research Publications Educational grants Independent CME (off-label uses can be discussed)

Influence over Content of CME? The Story of Gurkirpal Singh and Vioxx

• Merck targeted influential docs as speakers well before Vioxx was launched

• Gurkirpal Singh: Adjunct Clinical Professor of Rheumatology at Stanford. Sought because he had written about GI side effects of standard NSAIDs.

• Gave 40 lectures over 7 months – usually grand rounds or evening lecture over dinner

• Data on MI began to emerge; Singh asked to see data; results promised, but never provided

• Began to allude to concerns in his lectures

Reminder: The Vioxx bottom line

• Vioxx recalled after ~140,000 avoidable heart attacks; 38,000 deaths

• Most who took it would have done as well with ibuprofen.

• Cost: $2.5 billion each year

Dai C et al. Arch Int Med 2005; 165: 171

Singh: the plot thickens

• Email from Merck marketing manager: “Dr. Singh continues to play up the cardiovascular adverse events assoc. with Vioxx… many other speakers who deliver good messages, and we should not risk supporting the negative messages that he continues to deliver.”

• Merck execs conferred on how to rein in Singh; emails show they wanted to censor him but afraid of alienating him – even as some acknowledged concerns were legitimate

Singh: under surveillance• Merck surveillance of lectures by physicians with ties to

Merck. One document read: “Communication from advocate regarding a program given by Dr. Singh…It was hyper-inflammatory”

• Merck sales reps kept tabs on the buzz in Dr’s offices. As they gave out samples, they asked docs if they’d heard anything new about Vioxx; data transmitted to a company center

• Sample Document: “at 9 meetings in LA area over past 3 days, Singh presented sessions that were very unfavorable to Vioxx.”

• Dossier prepared for Merck Senior VP.

Singh: The Empire Strikes Back• Jim Fries, Professor of Rheum. at Stanford, got a Saturday phone call from

the VP: “stating that someone on my staff had been making wild and irresponsible public statements about the CV side effects of Vioxx.”

• Email by the VP: “Fries and I discussed getting Singh to stop making the outrageous comments he has in the past few months… I will keep the pressure on and get others at Stanford to help.”

• Also advises a marketing director: “Tell Singh we’ve told his boss about his Merck-bashing.” And tell him, ‘should it continue, further actions will be necessary (don’t define it)’”

• Similar calls to other Medical Schools about other speakers

• Merck maintains it was just trying to maintain balance in a vigorous public debate

Another Example of Influence over Content of CME: Neurontin

• Symposium for Am. Diabetes Assn. Annual Mtg.

• Abstracts reviewed by Proworx (Med educ. and communication Co. hired by Parke-Davis. Letter to P-D:

• “Negative content” in one abstract: contacted accrediting institution. Told they could ask to have specific product info removed if author could not provide refs. Still not satisfactory

• Slides requested for review by Proworx; company developed pre-written questions for the Q&A session to bring out the desired, more favorable information, and to counteract negative comments

• “If this had not been an accredited program, Proworx would have been able to probe the faculty member further to definitively establish program content and make the appropriate changes and/or recruit an alternative speaker.”

Summary: Drug industry & CME

• $1 billion/year investment

• Little FDA oversight; ACCME acknowledges many violations of policies on independence

• Marketing plans for new drugs include CME; often encouraging off-label uses

• Companies monitor the content of CME lectures closely; sometimes move to eliminate critical messages, assure positive messages