Monday, November 23, 2009
A scientific journal recently commissioned this story from me, but after I reported and wrote it, the journal killed it. I think it’s an important story that serves the public good, so I’m posting it here to get it on the record. BV
Drug makers routinely exploited continuing education seminars as opportunities to market pills to doctors, company documents reveal.
Continuing medical education (CME) has exploded into a $2.3 billion business in the United States, with nearly half of the funds pouring in from drug and medical device manufacturers. Physicians must complete a certain number of CME courses each year to retain their medical licenses.
Today, the large pharmaceutical companies say their CME dollars support only independent education, with no input from the companies. But as recently as 2004, the documents show, marketing personnel played key roles in developing the seminars, treating CME as one element of their comprehensive sales plans.
“It is very clear…that continuing medical education has been used as marketing, and I think it continues to be,” said Allan Coukell, director of the Pew Prescription Project, which seeks to reduce or eliminate conflicts of interest in medicine.
For instance, GlaxoSmithKline’s “2003 Tactical Plan” – a marketing document – for their antidepressant Paxil lists $92 million in expenses, including $4.3 million for CME, $30 million for consumer advertising and $17.4 million for free samples. The plan includes “desired” CME topics, such as “anxiety symptoms/disorders in women” and “treating depression & anxiety in hispanic population.” The plan also proposes a “CME Tour” reaching 6,000 doctors, and provides detailed topics to be covered. The company prepared similar strategies for 1999 through 2004, according to the documents, which were uncovered by Senator Charles Grassley (R, Iowa), in his ongoing investigation of the drug industry.
A spokeswoman for GlaxoSmithKline, Mary Anne Rhyne, declined to answer questions regarding the documents.
Forest Laboratories, Inc., deployed similar strategies to push Lexapro, a Paxil competitor. One goal of the 2004 Lexapro plan: “More sponsorships of CME, increased level of speaker programs…and peer selling.” The plan includes $9 million for national and regional “CME symposia,” to be run by a for-profit company, CME Inc. Also included: $600,000 to pay for six “special reports,” to be labeled as CME: “A reporter from…CNS News, Psych Times, and the Journal of Clinical Psychiatry will be sent to cover key Lexapro data” at medical meetings, the document reads.
A third drugmaking enterprise, a partnership between Merck and Schering-Plough, dumped $64.5 million into CME courses on “cardiovascular risk management and/or cholesterol control and/or Vytorin” from 2004 through early 2008, a time when the companies were heavily promoting Vytorin, their soon-to-be-troubled anti-cholesterol pill. The funds were distributed in 1,930 individual payments to universities, professional societies and for-profit CME companies.
Companies improperly promoting products via CME may run afoul of the law, said Lewis Morris, the counsel to the inspector general of the Department of Health and Human Services. During a July hearing of the Senate Special Committee on Aging, chaired by Herbert Kohl (D, Wis.), Morris said, “A number of significant cases have involved allegations that funding for ‘educational support’ was a pretext for the payment of kickbacks” to physician-speakers who promoted off-label, or unapproved uses, of certain drugs. For instance, in 2004, Pfizer and Warner-Lambert paid the U.S. government $430 million to settle claims that the companies “corrupted the physician education process by fraudulently sponsoring ‘independent medical education’ events” on unapproved uses of Neurontin, an anti-epilepsy drug, Morris testified.
The 2003 Paxil marketing documents show that GlaxoSmithKline planned to market the drug for an unapproved indication – pre-menstrual dysphoric disorder, or PMDD – 10 months before the FDA approved that specific use of the drug. The November 2, 2002 plan lists “anxiety symptoms in PMDD” as a “desired topic” of the CME seminars the company funded. But the FDA did not approve Paxil for PMDD until September 2, 2003. As Morris noted in his testimony, promoting an unapproved use of a drug is illegal under the Food, Drug, and Cosmetics Act.
Pfizer learned that lesson in a huge way last month when the Department of Justice announced the company had agreed to pay $2.3 billion – the largest criminal fine of any kind in U.S. history, according to the department – for illegally marketing several drugs, including its anti-inflammatory Bextra.
Murray Kopelow, chief executive of the Accreditation Council for Continuing Medical Education, which certifies CME providers, said his group tightened its rules in 2004. The rules now prohibit drug and device makers from directing educational content or even suggesting topics for courses. “We felt it necessary to define the bright line of what independence is,” he said.
Still, momentum is growing for an outright ban on industry-funded CME and a return to a system where physicians pay their own way, like lawyers and other professionals. The Institute of Medicine and the Association of American Medical Colleges support such a ban, and over the past two years, Stanford University, Memorial Sloan Kettering Cancer Center and the American Psychiatric Association have weaned themselves from the industry CME teat. Still, such funding comprises a critical slice of the budget pie for many professional groups. For example, the American Academy of Family Physicians, which claims 64,000 members, receives 8% of its operating budget from industry CME funds. President Ted Epperly said that AAFP follows ACCME guidelines and assiduously maintains a “firewall” between CME funding and content. “We believe this relationship can be managed,” he said. “It must be transparent and above board. You cannot have anybody telling you what the content ought to be, who the speaker ought to be.”
Where does Industry CME Money Go?
In 2008, drug and device companies spent $1.04 billion on continuing medical education in the U.S.
Where it went:
Hospitals: $39.5 m
Professional Societies: $202.5 m
For-Profit CME Companies: $463.4m
Other: $104 m
Source: Accreditation Council for Continuing Medical Education
Thursday, November 12, 2009
Wherever there is a vocal battalion of defenders of drug industry funded medical education, you are certain to find Tom Sullivan leading the charge. Sullivan writes the most prolific pro-industry CME website, Policy and Medicine. He is a founding member of ACRE, and managed all the logistics for
Simply put, Tom Sullivan loves pharma funding of medical education, and he simply can't get enough of it. Why? If you ask Sullivan, he'll wax idealistic, as he did in one of his recent posts:
"Industry CME funding improves quality, because it helps support the development of an accreditation system for compliance and professional accredited providers that thrive by demonstrating quality and developing innovative education that improves professional practice."
It would be nice to believe that his passion stems from such an altruistic vision of industry/physician collaboration. But it's not true.
Sullivan's incentive, like most of his colleagues, is money. He is the president of Rockpointe, a medical education communication company. And while I always figured he made a good chunk of cash from drug companies, I had no idea just how much, until now. The Drug Industry Document Archive (DIDA) at UCSF just released a number of documents obtained from congressional sources, one of which is this list of drug company payments to Sullivan's company.
Here’s how much industry "educational grant" money Rockpointe has made over the last three and a half years:
2009 (first half only): $3,237,027
Sullivan is awash in cash from all the major drug companies. In 2008, he made over $400,000 each from AstraZeneca, Bristol-Myers Squibb, Daiichi Sanyo, Eli Lilly, Medimmune, Merck, and Novartis.
He specializes in crafting web programs and meeting symposia that are infomercials for specific drugs. For example, Novartis paid Sullivan $98,998.00 to create a two hour breakfast lecture which took place at the annual meeting of the American Society for Hypertension on May 17, 2008. The Symposium was entitled “Blocking the Renin Angiotensin System: Which Way is Best?”
Here's which way is best: the Novartis way. Novartis markets Diovan, an angiotensin receptor blocker. Furthermore, the FDA recently approved Novartis’ Valturna, a single pill combination of Diovan and Tekturna/Rasilez, another direct renin inhibitor. This symposium was chaired by Matthew Weir, M.D., who, yes, is a consultant for Novartis and who has frequently boosted Novartis products (see here, for example.)
By the way, the president of the American Society for Hypertension is none other than Henry Black, M.D., who, along with his pal Tom Sullivan, is on the steering committee of
My, there are a lot of dots to connect when it comes to Tom Sullivan, Rockpointe,