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

GlaxoSmithKline Will Fund MECCs Under the Table

Yesterday, I reported on GlaxoSmithKline's announcement that they would no longer fund commercial MECCs (Medical Education Communication Companies) to produce CME programs. The big question was whether the company would allow academic centers and medical societies to subcontract course production out to MECCs, an arrangement more genteelly known as "co-sponsorship."

I just received the answer directly from Mary Anne Rhyne, GSK's GlaxoSmithKline Corporate Communications Director. Rejoice, all ye MECCs, your loophole is intact!

In this earlier op-ed piece in the New York Times, I had referred to industry-funded CME as a money laundering operation, in which drug companies do not directly pay doctors to give lectures, but instead pay a MECC to hire and pay the doctors. This provides the illusion that the drug company is not involved in the program, when of course the program wouldn't happen without company funding.

With this new brand of CME "reform," both Pfizer and GSK are simply adding another layer to this laundering operation. Now the money will go from the drug company to the academic medical center to the MECC to the doctor.

Over the years, MECCs have become experts at creating a series of dog and pony shows called CME. They have the process down to a science. They know how to make the flashiest slides, hire and manage the best key opinion leaders, rent out the nicest conference rooms, and serve the tastiest food. They make the process so seamless and effortless that academic medical centers are only too happy to hire them to do the dirty work of actually putting on the courses. Under GSK's new policy, I predict that universities will get the big grants and will pass on a chunk to the MECCs, keeping a healthy slice for their own highly profitable CME departments.

Unfortunately, the actual medical education will continue to be slanted in favor of the most expensive drugs and medical devices.

By the way, I also asked for a list of the 20 favored academic centers. The GSK spokeswoman said that this will be posted soon on www.partnersinknowledge.com, their website for grant applicants.

GlaxoSmithKline Stops CME Grants to MECCs

In another piece of good news for patient care, GlaxoSmithKline has announced that they are clamping down on funding continuing medical education programs. According to their press release, "GSK will no longer fund CME by commercial providers including medical education and communication companies (MECCs)." The new policy takes effect immediately.

The company says that it will cut down drastically on the number of organizations receiving CME grants, to only about 20 academic centers that meet their criteria of having a "track record of developing and delivering high quality medical education programs that have a measurable impact on improved patient health." I asked GSK for a list of the favored 20, as well as exactly what their criteria for CME excellence are, but I have not yet heard back.

GSK posts their educational and charitable grants on the web. You can read the grants from the first and second quarter of 2009 here. I went through the Q2 grants and found that it's pretty hard to tell which are CME grants and which are patient advocacy or charitable grants. But I estimated that in the 2nd quarter of 2009, GSK made CME grants to about 90 organizations, and about 20 (22%) of these are MECCs. While this implies that cutting out MECCs is not a big deal, in fact the MECCs are the big money hogs of the bunch. MECCs received by far the largest grants, including Pri-Med Institute ($658,000), Research to Practice ($540,000), Discovery Communications LLC ($420,000), and Physician Education Resource Group LP ($363,000). MECCs are great at sponging up lots of cash from drug companies, because they have no other business plan. Some of the money goes to physicians who give lectures, but much more is sheer profit, padding the pockets of MECC executives.

Thus, cutting out MECCs will presumably save GSK a lot of money and save doctors from getting pounded over the head with the redundant marketing messages MECC-produced CME excels at.

Some of you may recall that Pfizer announced a similar policy change over a year ago. You can read coverage of Pfizer's decision in this Medical Meetings article and in my blog post. While I applauded Pfizer's decision I also noted that their policy left the door open for eligible providers to co-sponsor programs with MECCs, a rather giant loophole that lead to problems with a huge $12.3 million anti-smoking initiative the company funded. Pfizer funded University of Wisconsin to coordinate the project, but allowed UW to work jointly with a few MECCs, including CME Enterprises. The result was that the CME program was biased in favor of Pfizer's Chantix, as detailed in this article in the Milwaukee Journal Sentinel.

Nobody knows whether GSK will allow a similar loophole. Let's hope not.

Paul Thacker: The Tenacious Hero of Reform

"Never doubt that a small group of thoughtful, committed people can change the world. Indeed, it is the only thing that ever has."

Or so said Margaret Mead, and I believe it's true.

One rarely gets the chance to meet such people, but on September 3, 2008, I was sitting in a popular Washington, D.C. Mexican restaurant blocks from the Capitol building, chatting with Paul Thacker. Few have heard of him, but many have heard about his boss, Charles Grassley, the senator from Iowa who has crusaded for transparency in industry-academic relationships. As Thacker and I ate enchiladas and chatted about Grassley's investigations, it became clear that Thacker himself was the spark behind the blizzard of letters and inquiries that ultimately exposed a slew of cozy arrangements between academics and the drug industry.

Now, Meredith Wadman has published this fascinating profile of Paul Thacker in the journal Nature, and it is required reading for anyone interested in the Man Who Brought Down Nemeroff, and more generally in the process of political reform. I won't even quote from it because I want to encourage you to read the article yourself (a subscription is required to read the whole thing). And for more on Thacker, check out this PBS documentary based on his earlier investigative reporting on the manipulated science sponsored by the tobacco industry and by deniers of global warming.

Schering-Plough: Committed to Corrupting every last Psychiatrist?

Since my last post about Schering-Plough's campaign to buy off doctors with invitations to join its Speaker's Bureau, a number of my colleagues have reported receiving their own invitations. Strangely, many of them are prominent opponents of industry-funded medical education.

For example, Ivan Goldberg, creator of the popular website Depression Central, and an outspoken critic of drug industry manipulation of doctors, received this letter. Check it out, because it's a little different from the one I got. They offered me $170,000 for 125 presentations (of 45 minutes each), while they offered Dr. Goldberg more money ($179,500) for fewer (only 96) presentations. In a phone conversation with Dr. Goldberg, he suggested that the differential was due to the fact that he lives in expensive New York City, but I assumed that Schering-Plough marketers calculated that he is worth more to them than I am. After all, they also offered Goldberg the lucrative gig of up to 5 "train-the-trainer" spots at $4500 apiece. This is where they would fly him to a meeting to stand at the podium and teach the teeming hordes of wannabe hired guns how to most effectively prostitute themselves.

Why is Schering-Plough sending these corrupting invitations to all the wrong people? Maybe the company employee in charge of identifying potential hired guns simply screwed up and didn't vet the mailing list adequately. Dr. Goldberg offered a different theory. He opined that perhaps all the bad PR about drug companies buying off doctors is dissuading MD's from accepting these gigs. Therefore, perhaps Schering-Plough is now forced to send out invitations to everybody, including "B" players and industry critics, in order to achieve their critical mass of Dr. Drug Reps.

What a fiasco for the company. Talk about a bad stumble as they are about to launch their new antipsychotic. I haven't heard any official Schering-Plough comment on this matter yet, but here is how I predict the statement will read: "Speaker programs are intended to enhance a healthcare professional's knowledge and patient care expertise." Wait--they can't use that line, because it was already used by Eli Lilly. I guess they'll have to make up their own sophisticated BS.

Schering-Plough to SAPHRIS Hired Guns: Come 'n Git It!

The FDA recently approved SAPHRIS (asenapine) for the treatment of both schizophrenia and bipolar disorder. It is available only as a sublingual tablet, meaning that it is not effective if swallowed, and it must be left under the tongue to dissolve for it to be absorbed into the bloodstream. I haven’t yet reviewed the studies to see if SAPHRIS has any advantages over other antipsychotics, but I do know that Jeffrey Lieberman, MD, who is Chair of Columbia University Department of Psychiatry as well as the head of the APA's Council on Research, was quoted in this article as saying that “The studies haven’t shown that [SAPHRIS] provides any unique therapeutic advantage. The main contribution is that clinicians and patients will have yet another choice.”

Advantage or not, Schering-Plough is already poised to make aggressive use of hired guns to get psychiatrists to prescribe its new antipsychotic.

Oddly, the company just sent me a SAPHRIS Speaker Bureau invitation packet. I guess my 2007 New York Times Magazine memoir describing the tangled ethics of promotional speaking has not yet become required reading at Schering-Plough.

Their invitation packet starts with this cover letter flattering me by saying, “As a recognized thought leader and well-respected healthcare professional among your peers, we are seeking your participation as a speaker in our Schering-Plough SAPHRIS Speaker’s Bureau….”

Then there is this Speaker Bureau Agreement in which you have to promise to go to a Schering-Plough training meeting (it’s not so bad—you get $3000 plus all expenses for a day and a half meeting), and in which you promise to use only company-sponsored information for your presentations.


But the meat of the packet is called Exhibit A, (part of which is pasted above) which tells you how much you’ll be paid:

--$1,600 for a 45 minute power point presentation or informal “peer discussion group.”
--$1,000 for a 45 minute web-based live presentation (you get $600 less because you don’t have to leave the comfort of your office)
--Total maximum (called “contract total aggregate”) amount that you may receive over the course of the year is $170,000.

Evidently, Schering-Plough is confident that it can attract all the hired guns away from both Eli Lilly and Pfizer, both of which have either started posting physician payments on the web (Lilly) or have promised to do so (Pfizer). Presumably, chastened doctors will be more likely to whore for a company that will keep their payments discreet. But the impending Physician Payments Sunshine Act will prove the old maxim, "you can run, but you cannot hide."

Forest's Promotional Objective: Use CME to Sell Lexapro

We have known for some time that the actual purpose of industry-sponsored CME (continuing medical education) is to increase prescriptions of the supporter's product. But few will admit it. The ACCME says that it accredits only CME that is unbiased and objective, even though half of it is paid for by the pharmaceutical industry. Leading medical societies appear to be willing to fight to maintain their God-given right to industry funding of CME until the world ends.

Finally, a major drug company--Forest Laboratories--has confirmed that CME is, in fact, advertising.

In today's New York Times, Gardiner Harris describes a smoking gun document that outlines in stark fashion how Forest has created CME programs for physicians in order to increase market share for Lexapro. The document, entitled "Fiscal Year 2004 Marketing Plan," can be read in all its inglory here.

Here are a couple of my favorite excerpts.

"PROMOTIONAL OBJECTIVES

• Achieve first place in detail dollar share of voice in the SRI market
• Maintain SRI category leadership in number of journal ad inserts
• Maintain SRI category leadership in total number of medical education events (Including CME symposia, speaker programs, teleconferences, and peer selling programs.)
• Generate significant Lexapro specific news coverage to both consumers and healthcare
professionals
• Have Lexapro included in all depression/anxiety related round up articles/stories that
discuss treatment"

Yep, there it is, number three on their list of strategies: CME symposia. But like any successful company, Forest leaves nothing to chance. In order to make sure that Lexapro-friendly CME got in front of potential prescribers, they came up with a variety of tactics, such as:

"A reporter from publications like CNS News, Psych Times, and the Journal of Clinical Psychiatry will be sent to cover key Lexapro data presented at important medical meetings. Data from ADAA (Anxiety Disorders Association of America), APA (American Psychiatric Association), AAFP (American Academy of Family Physicians, and AAGP (American Association for Geriatric Psychiatry) will be reported in the journal as a CME supplement.

Quantity:4
Cost per unit:$75,000
Estimated Cost: $300,000"

In other words, rather than waiting for doctors to decide to write their own articles singing the praises of Lexapro, Forest decided to hire reporters from journals to cover the CME symposia they already paid for. Based on the reporting, ghostwriters would then scribble the articles, and plant some psychiatrists' names as authors. The articles would be packaged as "CME supplements" with the journals.

It's so much more...efficient this way!

There's more in this document, much more. Please give it a read, but I suggest you do so on an empty stomach.