Canadian Medical Association Gets Dumb (and $780,000)

The Canadian Medical Association is getting plenty of flak about their $780,000 CME deal with Pfizer, and anyone with half a brain can see why. Pfizer is not in the business of altruism. When they spend lots of money, they do so in order to make their shareholders happy.

For example, when the company cut a $12.3 million CME deal with a collaborative including the University of Wisconsin and the California Academy of Family Physicians, they did so in order to encourage doctors to talk to their patients about smoking cessation. Presumably, this increased sales of Pfizer's anti-smoking drug Chantix. While this CME program, called CS2 Day (Cease Smoking Today), does not have the blatant infomercial feel of most commercial CME, it treats Chantix with kid gloves. As covered in the Milwaukee Journal Sentinel, an online course for doctors fails to mention a small piece of the Chantix puzzle--the fact that its side effect profile includes serious psychiatric symptoms. Heck, they didn't mention any of their product's side effects in the presentation. You call that accredited CME?

So now the officials at the Canadian Medical Association are chugging the same kool-aid as UW's director of CME, George Mejicano, who had defended the Pfizer-funded courses with a pile of nonsense: "He said such courses are rarely comprehensive and are designed to meet selected learning objectives.” Now listen to his Canadian colleague:

“There's no connection between the funder and the people who are actually providing the content,” Dr. Sam Shortt, CMA's director of knowledge transfer, said. “We're confident that these two elements meet and exceed any expectations from any observer.”

In my experience with colleagues from Quebec and Ontario at American Psychiatric Association meetings, Canadians are generally far from naive--so why did Dr. Shortt and the CMA turn off their neurons? Hmmm. Let me count the reasons--all 780,000 (U.S.) of them.

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

Tom Sullivan, of ACRE Fame, Is Swimming in Drug Company Cash

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 ACRE's first embarrassing meeting, held at Brigham and Women's Hospital. He collaborates closely with John Kamp, director of the pro-commercial CME front group, Coalition for Healthcare Communication.

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:

2006: $4,209,685

2007: $8,701,080

2008: $7,298,064

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 ACRE, and is also a consultant for Novartis.

My, there are a lot of dots to connect when it comes to Tom Sullivan, Rockpointe, ACRE, and the many physicians who have decided that helping drug companies market their products is the ethical way.

New York Times Covers Industry Funding of CME

It is unusual for the New York Times, or any other national news organization for that matter, to focus industry-funded CME. With examples of corrupted business practice everywhere, this particular little slice of corruption is easily glossed over. But Duff Wilson, in today's NYT business section, does a good job of covering the issue, and the big paper's attention has apparently done what nobody else has been able to accomplish--convincing the ACCME to finally publish its Rogue's Gallery of MECCs found guilty of commercial bias.

The article is centered on a little gem put out by CME Outfitters called "Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough." Funded by AstraZeneca, it is an elaborate commercial urging psychiatrists to use more atypical antipsychotics as adjunctive treatment of major depression.

Bernard Carroll, a psychiatrist and blogger for Health Care Renewal, complained about the program (see his post here) and while it took ACCME nine months, they eventually agreed that the program was biased in that it "lacked sufficient information about possible adverse effects of treatment with atypical antipsychotic drugs; and failed to emphasize sufficiently the efficacy of alternative treatments."

Apparently CME Outfitters has taken the program off its website, but never fear, I've managed to get ahold of the slides and have published the pdf on Scribd here.

The interesting thing is that while this course certainly is commercially biased in favor of atypicals, it is hardly the most blatant example of commercial bias I've seen. In fact, if you go right now over to the new activities area of CME Outfitters (called "neuroscience CME"), you'll find a entire series of "CME snacks" on the "Complex Presentations of Sleep Wake Dysfunction," each of which is a mini-commercial for Provigil and Nuvigil brought to you by Cephalon, which markets a vastly lucrative alertness drug empire.

My point being that if the Atypical Antipsychotic program is bad enough to be pulled for commercial, my conservative estimate is that at least half, probably more, of all industry funded psychiatry CME will also need the retraction treatment. The problem is, who on earth has the time to police these things? Certainly not ACCME. Dr. Carroll and I try to keep on top of the worst of the worst, but we have other things to do in order to make a living. The best and simplest solution would be to end industry funding of medical education altogether.

Indianapolis Star Reports on CVS Caremark-Eli Lilly Marketing Scam

For most of us, blogging is a labor of love, and our payment is the possibility of having a positive impact in the world. So it was gratifying to see that the Indianapolis Star published this story prompted by my prior post about how Eli Lilly is paying CVS Caremark to sell doctors on Cymbalta for fibromyalgia.

Reporter John Russell did an excellent investigation, finding that the practice is more widespread than I realized. For example, he interviewed Dr. Matthew Mintz, an internist in Washington, D.C., who said he too had received a deceptive pharmacy drug ad, this one funded by Merck and encouraging Dr. Mintz to switch one of his diabetes patients from a different company's drug to Merck's Januvia.

The Star's Russell also revealed that Lilly had used the pharmacy-whore technique to sell Zyprexa in 2002, when it apparently paid another drug benefit manager, AdvancePCS, to send out 120,000 letters promoting Zyprexa to doctors nationwide. AdvancePCS hawked its services for $5/letter, meaning that they stood to make $600,000 from the scam. In documents forced public in the context of a trial, AdvancePCS officials wrote that this direct-mail campaign was "designed to influence key prescribers" as part of a "tactical plan for Zyprexa."

Lilly declined to say whether it took AdvancePCS up on the offer. Translated from PR speak, this means, "Yes, we did pay them the $600,000 but it was such an obviously slimy marketing technique that we will not admit it."

An Eli Lilly spokeswoman told the reporter that the latest CVS Caremark letter was simply meant to "share medically accurate and relevant information with health-care professionals," and denied that it was deceptive at all. I guess we'll have to wait for another trial to find out that this, like the earlier Zyprexa letters, was designed as a "tactical plan," this time for Cymbalta.

At any rate, the debacle may have a silver lining for us all, since Lilly told the Star that they are "re-evaluating the entire practice" of using pharmacies to market their drugs to doctors.

That's great. Lilly is quite proud of its good corporate citizenship. Last year, John Lechleiter, Lilly's CEO, crooned in this press release that "With each of our industry firsts, from launching our clinical trials registry to the public reporting of educational grants, Lilly is striving to be a leader in improving transparency across our industry. As Lilly continues to look for more ways to be open and transparent about our business, we've learned that letting people see for themselves what we're doing is the best way to build trust."

Dr. Lechleiter failed to mention that Lilly's decision to become a leader in transparency was done with a gun to its head--it was part of a corporate integrity agreement that was bundled with $1.4 billion fine for illegal off-label marketing of Zyprexa.

Details, details.

CME Outfitters: Guilty of Pro-Seroquel Bias, According to ACCME

In ACCME's testimony before the Senate Special Committee on Aging on July 29 of this year, Dr. Murray Kopelow, the chief executive of ACCME, defended the integrity of the embattled organization in part by pointing out that they have beefed up their enforcement of anti-commercial bias policies.

He said that he has begun to give extra "scrutiny" to organizations that "receive a large amount of commercial support," and said that 10% of all ACCME providers are now on probation. But how well does ACCME actually regulate the bad apples of CME--generally speaking, those for profit MECCs who are completely dependent on commercial support for their very existence and who consistently bend the Standards of Commercial Support in order to maintain the flow of money?

In a fascinating post by Bernard Carroll on Health Care Renewal, we get a close-up view of ACCME's new commitment to enforcement, which while showing some signs of life is severely lacking in bite.

Dr. Carroll had filed a formal complaint on December 23, 2008 about a web-based round-table discussion of the use of antipsychotics in depression, which was chaired by Charles Nemeroff (the disgraced psychiatrist who resigned under pressure as chair of psychiatry at Emory after the New York Times reported that he lied to the University about payments from GlaxoSmithKline, promising officials that he would limit his earnings to the required $10,000/year from promotional talks, then going on to earn $170,000 that year alone.)

Nemeroff's program was produced by CME Outfitters and was funded by Astra Zeneca, maker of Seroquel, an antipsychotic which was recently approved for add-on treatment of depression. After its investigation, according to Dr. Carroll, the ACCME determined that the program did, indeed, violate its standards. In particular, the course was commercially biased in favor of the sponsor's treatment because it downplayed negative side effects of Seroquel while giving short shrift to alternative, safer depression treatments.

So far, so good. The monitoring system appears to be working. Or is it?

Dr. Carroll asks a series of questions that will prod ACCME to think about the logical next step.

--If this accredited CME program was corrupted by commercial bias, shouldn't the ACCME force CME Outfitters to contact all the physicians who participated in the course in order to explain to them that they were given biased medical information?

--Shouldn't the CME credit obtained through this program be revoked?

--Shouldn't CME Outfitters be required to ascertain whether patients were harmed as a result of their biased education (for example, how many patients were put on Seroquel for depression and later developed obesity, diabetes, or heart disease as a result?).

--Will ACCME publically list its sanctions against CME Outfitters and other MECCs who have aired commercially biased CME? Or are we going to have to depend on the occasional blogger to reveal these egregious cases?

These are all crucial questions, and Dr. Carroll is awaiting a reply. Aren't we all?

Eli Lilly Hires CVS Caremark to Push Cymbalta

Eli Lilly has discovered a new advertising strategy: your pharmacy.

Check out this package of material I just received from CVS Caremark, a prescription benefit plan associated with CVS pharmacy. Pure and simply, it is an advertisement for Cymbalta, Eli Lilly's antidepressant which was recently approved for the treatment of fibromyalgia.

But it doesn't look like an ad. It looks like a letter from a pharmacy that is deeply concerned that my fibromyalgia patients receive the best treatment. Here's how the letter starts:

Dear Doctor:

CVS Caremark administers the prescription benefit plan for one or more of your patients. We are committed to providing health care professionals with information about drug therapy. As part of this commitment, we are providing you with this issue of RXViewpoints®, which focuses on the management of fibromyalgia with Cymbalta® (duloxetine HCI). Cymbalta is a therapeutic option on the CVS Caremark preferred drug lists. Patients may have a lower copayment for medications on these drug lists. Some prescription benefit plans may limit quantities or require prior authorization.

The letter came in a 9 X 12 inch envelope proclaiming "Confidential--May Include Protected Health Information." Along with the letter is a newsletter called "Rx Viewpoints" that appears to be written by Eli Lilly staff extolling the benefits of Cymbalta for fibromyalgia.

How touching that CVS Caremark is, in their words, so "committed to providing health care professionals with information about drug therapy." At the end of the letter, in small print, the source of all this benevolence becomes a tad clearer:

How much is Eli Lilly paying CVS Caremark to perpetrate this deception? Which executive at CVS became so overcome with greed that he or she approached Eli Lilly about this joint venture? Has CVS Caremark informed its patients that it is selling their pharmacy information to a drug company?

Whatever amount of money CVS is making on this scam, it had better be a bundle, because the pharmacy is going to have to spend at least that much dealing with the PR fiasco certain to be triggered by this foolish business decision.

I've called doctors who speak for drug companies "drug whores," a term that offends some readers. CVS Caremark has added another flinch-worthy phrase to the lexicon of medicine: "Pharmacy whores."