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."

The Boston Globe: Let's Ban Hired Guns

Yesterday, the Boston Globe published an excellent editorial entitled: “Keep doctors independent; ban fees from drug makers.” Responding to revelations that Eli Lilly paid out $22 million in fees for promotional talks to doctors over the first 3 months of 2009, the Globe believes that “legislators should go beyond requiring disclosure of the relationships, and ban the practice.”

The piece soundly concludes that:

"Patients trust doctors as stewards of their health. They revere them as scientists who can exercise sound, independent judgment. Allowing doctors to promote drugs for pharmaceutical companies takes advantage of that trust and reverence. It also compromises doctors’ most important work: treating people who are ill."

I agree that doctors should cease speaking for drug companies, though I’m not convinced that legislation is the best way to accomplish this. Since the practice is unethical, it should be regulated in the same way that other matters of medical ethics are regulated—via medical societies and state medical licensing boards.

At any rate, I perused some of the dozens of comments to the Globe's editorial, and here are three common categories, along with my rebuttals.

1. Doctors are not wealthy and greedy. They train hard, only make around $150,000 per year, have lots of overhead, etc. Doctors are so poor that they need and deserve to supplement their income by speaking for drug companies.

Here’s a news flash, people. Most doctors are not poor; in fact, they are rich. In 2008, the average physician income ranged from a “low” of $159,000 (family practitioners) to a high of $527,000 (neurosurgeons). This places their income in the top 5-10% of all American wage earners, according the health economist Uwe Reinhardt.

Doctors don’t speak for drug companies because they need the money to feed and clothe their starving families. They do it because it’s fun and interesting, provides narcissistic satisfaction, a social outlet, and gives them extra money for the finer things in life. The point of the editorial is that doctors should make their money by practicing medicine rather than by promoting drugs.

2. But how will doctors get their medical education if drug companies can’t pay experts to give lectures?

There are hundreds of medical journals covering every conceivable specialty—here’s one list of them. Likewise, here is a directory of the hundreds of medical conferences throughout the US held in every state, varying widely in cost. Most medical education lectures are held in hospitals and academic medical centers as part of grand rounds, most of which are freely available to doctors in the community. The funding varies, sometimes coming from medical staff fees, sometimes from drug company money donated to a pool of funds that can be used at the hospital’s discretion—a far cry from doctors signing contracts to speak for drug companies.

3. You think doctors are greedy? What about congressmen and senators—look at all the money they get from drug companies and insurance companies. That’s where you should focus.

First, all contributions to elected officials are transparent and are available from a number of websites, such as http://www.opensecrets.org/. Second, politicians have, by definition, innumerable different consituents and interests, and it is appropriate that they receive campaign donations from these varied constituents. Not so for doctors. We don’t have different “constituents.” We have a single constituent: our patients. Our single professional responsibility is to treat them. On the other hand, we have no responsibility to drug companies to help them sell their drugs, and therefore we have no responsibility to accept money from them for that purpose. Research is different, because medical research is directly related to patient care, and so accepting drug company money for clinical research is far more defensible.

Kudos to the Boston Globe for taking such a strong and principled position on this issue.

The Ethics of Speakers Bureaus under the Spotlight

Eli Lilly's publication of a registry revealing all payments to doctors has opened up an overdue conversation. Is it ethical for a doctor to become a member of a drug company speaker's bureau? Or is it inherently deceptive for a doctor to pose as being an independent source of information while at the same time being under contract to speak for specific drugs?

In today's Boston Globe, Liz Kowalczyk does some investigative reporting based on information gleaned from the Lilly Registry. She found that two physicians at Boston Medical Center (BMC), neurologist Brian McGeeney, and endocrinologist Elliot Sternthal, were each paid thousands of dollars by Lilly during the first three months of 2009 to give education talks to other physicians. But according to Kowalczyk, for the past two years BMC has officially barred doctors from giving industry-sponsored talks unless the “lecture’s content, including slides and written materials, are determined by the clinician.’’

In fact, drug companies never allow doctors to determine their own content for promotional talks. As I described in a prior post, for example, Schering Plough's contract (view it here) for its asenapine speaker's bureau was explict in this regard: "You will used only the Schering approved materials for all presentations performed under this Agreement." While I have not seen Eli Lilly's speakers' contracts, on their website they describe their "healthcare professional education" in the following way: "The information presented in these programs is provided by Lilly alone, is closely regulated, and must conform to U.S. Food and Drug Administration (FDA) requirements."

I think this is pretty clear. The content is produced by Lilly, and not by the doctor giving the talk.

Given all this, it sounds very much like Drs. McGeeney and Sternthal did, indeed, break their employer's rules regarding allowable industry activities. Unfortunately, rather than admitting this, they defended themselves in e-mails to Kowalczyk in the most unconvincing terms:

Sternthal said he determines “the structure of the presentation by my choice of disease state and clinical trial slides, order of presentation and emphasis of teaching points. This is in compliance with BU/BMC policy.’’

Whaaaat? We know what disease state Dr. Sternthal chooses for his talks--it is diabetes, for which Lilly markets a plethora of products, including Byetta. We also know what "clinical trial slides" he chooses--those slides showing research conducted by Lilly to show that its diabetes products are effective. The fact that he chooses the order of his Lilly-boosting slides hardly constitutes compliance with BMC's policy that the "lecture’s content, including slides and written materials, are determined by the clinician.’’ Sternthal might argue that he follows the letter of the rules because he, in fact, determines which among a menu of Lilly slides he uses in his presentation. But this is a hollow argument, because he didn't write the menu.

Here's an analogy. If my son comes home and says that for lunch he ate a cheeseburger and french fries, I might express my dispeasure and ask him to make healthier choices in the future. "But there was nothing else on the menu," he might respond. "Where did you go for lunch?" "McDonalds!" If you choose to go to McDonald's for lunch, your "choice" of food is severely limited. Similarly, if Dr. Sternthal chooses to go to Lilly for his medical information, every slide on the menu will be Lilly-friendly, meaning that his defense that he "chooses" what to teach is meaningless. His only choice was to become a promotional speaker, and he checked his academic independence at the door.

This behavior is inherently unethical, because it demeans the reputation of all doctors. How can patients have faith that doctors are making independent medical decisions when they hear about the Dr. Sternthal's and Dr. McGeeney's of the world defending themselves in such ways? Such doctors are gradually undermining the public's trust in all physicians.

Priceless: Two Items from the GlaxoSmithKline PR Spin Machine

Item #1: From the GSK "Frequently Asked Questions" page:

Does GSK fund CME programs in order to influence doctors and get them to prescribe your medicine?

No, not at all. GSK is committed to supporting quality healthcare education. Our goal is to support independent medical education programs for healthcare professionals (physicians, nurses, pharmacists and other healthcare professionals) to increase their knowledge, competence, performance and ultimately improve patient outcomes. Doctors and other healthcare professionals must take CME/CE courses to maintain their licenses and hospital privileges. The Accreditation Council for CME (ACCME), Accreditation Council for Pharmacy Education (ACPE), American Nurses Credentialing Center (ANCC) and others set accreditation criteria for the programs to physicians, pharmacists, nurses and other healthcare professionals. It is also important to note that GSK does not control the content of independent educational programs and that the purpose of the programs is not to promote GSK products.

Item #2: The URL of the GSK web page for organizations seeking CME grants:

WWW.PARTNERSINKNOWLEDGE.COM