Monday, November 23, 2009

Brian Vastag's Concise Review of How Drug Companies Use CME for Marketing

What follows is an article written about commercial CME by the science journalist Brian Vastag, who writes for a number of publications, including the Washington Post, U.S. News and World Report, and JAMA. You can read the article on his blog at http://brianvastag.net/2009/10/cme/, but I have also reproduced in its entirety below, because I feel it is such an important piece of journalism. Congrats to Brian Vastag for telling it like it is.

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


Universities: $225.7m


For-Profit CME Companies: $463.4m


Other: $104 m


Source: Accreditation Council for Continuing Medical Education

7 comments:

Michael S. Altus, PhD, ELS said...

Re: “To the WSJ Editors: Readers Deserve Better Than Alicia Mundy” (November 16, 2009 11:30 AM; [bmartinmd.com/2009/11/alicia-mundy-cme-report.html]), a post on Pathophilia, the blog of Barbara J. Martin, MD

Dr. Martin commented, “A drug firm is not going to fund a CME program that is outside its therapeutic area of interest.”

It follows then, that overall, commercially supported CME is biased, whether or not individual commercially supported CME programs are biased. That is, the selection of subjects to be covered by commercially supported CME programs is biased to cover subjects of interest to the pharmaceutical company supporters.

Doc Righteous said...

I recently overheard drug reps tell the physician CME educator that during the Q&A, if s/he got an opening, s/he could use it to flog the drug's off-label uses. This is their loophole of last resort, apparently.

Cetamua said...

"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.

Does this guy think he's kidding anyone? The runaround to skirt these rules has been obvious: An informal chat between industry contact and a CME provider will tell the latter all he/she need to know in order to make a "proposal" to the Pharma corporation marketing division.

This way, the pharma is provided with the necessary plausible deniability, since they did not "initiate" the formal discussion about topics...the CME provider did.

A tightening of the rules...yeah right!

Joel Hassman, MD said...

Um, now that we have more documentation to clarify what we already know, how about implementing long lasting changes for the better? Like, starting with state boards that monitor CMEs for physicians, asking they do not accept pharma sponsored CMES like the "free" ones in throw away journals as a start. Maybe when physicians get threatened with not renewing their licenses because their CME credits aren't from responsible unbiased, independent sources that, god forbid the idea, such truly responsible and independent sources get approval from state boards as accredited sources, then the concept of unadulterated CMEs may sink in as the accepted norm.

But, let's be honest, we work with cheap, lazy, minimally committed colleagues these days. They just seem to forget the simple adage "you get what you pay for". So, you pay nothing, you get pretty much nothing in return. Gee, Paxil, Zyprexa, Seroquel, Lexapro, are just such wonder drugs for the general populace. Tell that to some of my patients who have not benefitted from the overprescribing by predecessors.

The only solace I get is those who depended on these pharma CMEs who have prescribed meds sold by the companies mentioned above will get their due when sued for irresponsible prescribing. What goes around, comes around, eh?

Anonymous said...

David Armstrong’s reporting on ongoing lipitor litgation and the allegations related to the Pfizer’s use of CME are relevant to this post.

http://blogs.wsj.com/health/2007/12/20/a-jug-of-wine-a-loaf-of-bread-and-lipitor/

online.wsj.com/article/SB119811136568740957.html

I am currently reaching out to faculty and participants for a range of these national pfizer funded programs related to lipid management. Programs such as the “Emerging Science of Lipid Management”, “National Lipid Education Council”, “Vascular Biology Work Group”, “Coalition for the Advancement of Cardiovascular Health”, “Heart Advocacy Network”, and “Shape”.

The underlying complaint is linked on Pharmalot.

http://www.pharmalot.com/2007/12/pfizer-sued-by-former-exec-over-lipitor-marketing/

jesse polansky md
issac4a@yahoo.com

FPMHA said...

Great article.

In the country like Sri Lanka, we are doing this little bit a different way. Actually we have community based organisation like Foundation for Promotion of Mental Health Ampara (FPMHA) (http://www.fpmha.info) and do CME among the general public.

We find money from donations.

Thanx

FPMHA said...

Great article.

In the country like Sri Lanka, we are doing this little bit a different way. Actually we have community based organisation like Foundation for Promotion of Mental Health Ampara (FPMHA) FPMHA and do CME among the general public.

We find money from donations.

Thanx