Hospitality and Pharma: Relationship on the Rocks?

Decades of mutually beneficial economic ties have bound the fortunes of hotels, restaurants, and drug companies. But in an era of Sunshine Act disclosure, renewed calls for professional ethics, and ballooning healthcare costs, that relationship may be souring.

It used to be a veritable love-fest. As recently as 2011, I was writing about a restaurant's attempt to rebrand itself as a "pharmaceutical dinner facility."  In 2010, I debated a restaurant chain owner who was calling for the Massachusetts legislature to repeal the state's 2009 gift ban so drug companies could once again wine and dine doctors at his restaurants. His lobbying turned out to be successful. The state's previously strict law was revised in 2012. Now it allows industry representatives to purchase meals of a "modest value" outside the office or hospital as long as they provide educational information about their products between courses.

However, it turns out that while hospitality industry owners are working double time to book reservations for doctors and pharmaceutical reps, their employees have an entirely different idea. They--correctly--see drug company relationships with doctors as a driving force in their rising health care costs, and they want pharmaceutical companies to stop funding educational CME programs at their hotels.

Last week I wrote about this brave stance from the hospitality worker's union Unite Here ("Hotel Workers Against Industry-Funded CME?"). The Wall Street Journal​'s Pharmalot blog got in touch with me to discuss the matter further and yesterday they posted a follow up that includes more of my thoughts on the matter and more of ACCME's self-serving response.

Looking back over the recent history of these industry dynamics, it's easy to see more workers taking this stand against business as usual. After all, they go to work every day in the middle of a money storm while simultaneously seeing their health costs rise year after year. That's a pretty good reason for them to want to stand up.

You can help them out by signing the No More Drug Money petition they are promoting and by sharing it around.

New JAMA History of CME: "When Will We Ever Learn?"

The current issue of JAMA (Journal of the American Medical Association) contains this interesting history of the relationship between the pharmaceutical industry and medical education.

It turns out that the rancorous CME debate that we consider to be modern is anything but, having its origins in the late 1950s, and early 1960s, when direct marketing to physicians in the guise of education heated up.

In 1961, for example, Charles D. May, the editor of the journal Pediatrics, wrote the article, “Selling drugs by educating physicians,” in which he bemoaned the body-snatching of medical education by the pharmaceutical industry:

A vicious cycle is created by a mad scramble for a share of the market: the doctor is made to feel he needs more “education” because of the prolific outpouring of strange brands but not really new drugs, produced for profit rather than to fill an essential purpose; and then the promoter offers to rescue him from confusion by a corresponding brand of “education.”

Now, nearly 50 years later, Dr. May’s quote still captures the essential damage done to medical practice by industry funding of CME.

Given recent events, it is ironic that one of the most outspoken advocates of industry sponsored medical education was a psychiatrist: Arthur Sackler, who was also a partner (and later owner) of the William Douglas MacAdams agency, a prominent pharmaceutical advertising firm. In his 1957 reply to reformers of CME, using an argument that has not changed in a half century, Sackler argued that physicians are fully able to read pharmaceutical marketing critically. “Pharmaceutical advertising,” he wrote, “has made one of the major contributions in the rapid dissemination of new therapeutic information.”

The JAMA paper also reminds us that long before Charles Grassley and the Senate Finance Committee began its current investigations, two congressional hearings had already led to some reforms: the Kefauver Hearings of 1959-1962, and the Kennedy hearings of the early 1990s. The Kennedy hearings forced PhRMA to develop its “voluntary” ethical codes, and also led ACCME to issue the first version of its Standards for Commercial Support.

However, the JAMA authors note that these reforms have accomplished little:

Nonetheless, the standardization movement of the 1990s did little to stem the growth of the medical education and communication industry, and instead may have helped to legitimize and create a legal defense for the industry, which has increased steadily since that time.

In concluding, the authors rightly lay the blame squarely in the lap of physicians, who have thus far been unwilling to bite the bullet and pay for their own medical education:

As advertising executive Pierre Garai noted in 1963: “The drug business is today, and will be tomorrow, what the doctors cause it to be. Drug advertising too.”Any responsible analysis of the role of pharmaceutical promotion in CME must account for the process by which individual physicians, organized medicine, and the regulatory state allowed and even encouraged this process to take place. Garai finished with the question: “We know what the doctors are today. What will they be tomorrow?”

Indeed, what will we be tomorrow? It is up to us.

As George Santayana once said, "Those who cannot remember the past are condemned to repeat it."

Macy Foundation Bombshell: Industry-Funded CME Must End

The clock is ticking for industry-funded medical education. The latest body blow comes in the form of a report on medical education issued by the influential Josiah Macy, Jr. Foundation. Read it here. The report was the product of a conference attended by many of the brightest minds in medicine, including Catherine DeAngelis, editor-in-chief of JAMA, Harvey Fineberg, president of the Institute of Medicine, and David Leach, recent executive director of the Accreditation Council for Graduate Medical Education.

The Macy Foundation couldn't be clearer: commercial support of CME has got to go.

Here is the most powerful section of their report (you can find it on page 2 from the link above):

"Participants warned that the health professions, especially medicine, threaten the ethical underpinnings of professionalism by participating in a multi-billion dollar CE enterprise so heavily financed by commercial interests. This arrangement, which evolved over the years, distorts continuing education. It places physicians and nurses who teach CE activities in the untenable position of being paid, directly or indirectly, by the manufacturers of health care products about which they teach.

At the same time, commercial support of CE places learners in an obligatory position because they are often given free meals and small gifts. Independent judgment of how best to care for patients is compromised. Bias, either by appearance or reality, has become woven into the very fabric of continuing education.

The professions, themselves, must right this wrong. In a free-market system, commercial entities, such as drug and device manufacturers, have a clear responsibility to shareholders to gain market advantage and generate a profit, while health professionals have a moral responsibility to provide safe, high quality care for their patients, based on valid scientific findings. The two responsibilities are fundamentally incompatible.

Even if bias could be avoided, the potential, and the perception, are ever-present. Companies with billions of dollars at stake cannot be expected to be neutral or objective when assessing the benefits, harms and cost-effectiveness of their products, for they are in the legitimate business of gaining market advantage and want clinicians to use and prescribe their products. Yet, an objective and neutral assessment of clinical management options is precisely what is needed in continuing education.

Participants emphasized that, regardless of the financial impact on for profit companies, patient care must be based on scientific evidence and commercial interests should not determine the topics or content of CE. Because of these underlying ethical issues, participants concluded that the commercial entities that manufacture and sell health care products should not provide financial support for the continuing education of health professionals (emphasis added)."

The Journal of Abilify Psychiatry: A CME Activity

I just received the latest Supplement of the Journal of Clinical Psychiatry.

The Journal of Clinical Psychiatry, which is published by Physicians Postgraduate Press, Inc., and is edited by Alan J.
Gelenberg, has developed a reputation for publishing CME supplements which are biased in favor of the sponsoring drug company.

Thus, the current supplement, paid for by Bristol-Myers Squibb, reads like an advertisement for Abilify.

The supplement is titled "Translating the Psychopharmacology of Antipsychotics to Individualized Treatment for Severe Mental Illness: A Roadmap." Sounds promising to me, though rather vague.

The issue is billed as being the result of an "Expert Consensus Survey." This means that BMS paid a third party for-profit company, Comprehensive Neuroscience, Inc., to cherry-pick experts and to send them a list of questions about their favorite antipsychotics in various clinical situations. The responses were tabulated into a series of charts that form the backbone of this supplement.

To understand why BMS would choose this method of CME promotion, you have to understand the context. Their antipsychotic, Abilify (aripiprazole), was not included in the influential CATIE trial, because it was approved after the trial was completed. Thus, while Eli Lilly (Zyprexa), AstraZeneca (Seroquel), and Pfizer (Geodon) have been able to tweak CATIE results to their advantage, Abilify has little in the way of head-to-head science to back up claims of advantage over competitors. Commissioning an "Expert Survey" allows BMS to round up key opinion leaders who they already know have positive opinions about Abilify, choose questions about topics that will tend to play up Abilify's advantages, and then publish the pre-planned answers.

Let's look at the results of this novel form of drug comparison research.

The supplement highlights the results of 17 questions. Eight of these were questions about general strategies, and nine were quite specific, asking which of a list of specific antipsychotics the experts would favor in given situations. How do the experts rank Abilify in these nine questions comparing it with its direct competitors?

--In seven of these comparisons, Abilify is ranked number one (see page 30 of the supplement).
--In one comparison, Abilify is ranked number two (page 21).
--In one comparison, Abilify is ranked number three (page 26).

Oddly enough, Zyprexa was at the bottom or near the bottom in all of these rankings, even though some of these same experts have written elsewhere that Zyprexa was the most effective of all newer atypicals in the CATIE trial.

Why did Abilify come out on top? Because of the types of questions these experts were asked. Most questions asked which antipsychotic the experts would choose in patients who were overweight, had cardiac disease, or who had diabetes. This is a great way to stack the deck in favor of Abilify.

The expert panel's rankings would surely have been in favor of Zyprexa if they had been asked to choose an antipsychotic based on efficacy alone. Abilify would have ranked very low indeed if they had been asked to choose a treatment for patients who suffered insomnia, anxiety, or agitation. These are all important clinical questions in the field, but were not asked because the answers would not have promoted Abilify.

Shame on Journal of Clinical Psychiatry for publishing such pseudoscience.

Biased Education: A Summer's Cornucopia with CME, LLC

I've been on vacation in New Hampshire for the past week, giving me an opportunity to appreciate summer's bounty. Now, getting back to business, I realize that the cornucopia doesn't end at a dinner table overlooking a New England lake. Throughout the world of commercial CME, there is enough pro-sponsor bias to leave us all sated, whether we are on vacation or not.

The first course of what will undoubtedly be a long summer feast of bias is provided to us by one of the largest medical education communication companies, named, aptly enough, CME, LLC. This is the dominant provider of commercial CME in psychiatry, publisher of Psychiatric Times and sponsor of the well-attended U.S. Psychiatric Congress, heavily subsidized by industry-supported symposia.

Recently, perusing the web, I came across one of their programs entitled "Bipolar University," a "lifelong learning initiative" set up in response to the "pressing need to educate clinicians about bipolar disorder."

Navigating to "educational components," I clicked on the first of several offerings listed, "CME Articles with Interactive Case Studies." I chose the first article, "A Case-Based Guide to Using Treatment Guidelines in Bipolar Disorder," by Trisha Suppes, MD, PhD and Deborah Kelly, MA. I invite you to visit this activity now, which will require a free registration process. You'll see that the point of the lesson is to teach us how to apply the Texas Implementation of Medical Algorithms (TIMA) to the treatment of bipolar disorder. For those who have not heard about TIMA, it is an updated version of TMAP, the Texas Medication Algorithm Project, originally developed in 1997 with funding from both the Robert Wood Johnson Foundation and several pharmaceutical companies.

You can already see that something fishy is going on here, because an article ostensibly about the general topic of treatment guidelines is actually an exposition of one particular, industry-friendly guideline.

At any rate, the article itself is a discussion of TIMA's recommended treatments for both bipolar mania and bipolar depression, illustrated by two case examples. In the first case, we hear about a 35 year old woman who presents with mixed mania, and is treated with valproic acid and risperidone to good effect.

The second case is where things get more interesting, and where our summertime feast of CME bias really begins. This is a 30 year old man with bipolar disorder, already on lithium monotherapy, who presents with symptoms of major depression. The patient is started on Lamictal, which is TIMA's first line recommendation for treating bipolar depression. However, unfortunately for GlaxoSmithKline (maker of Lamictal), the patient suffers unspecified "side effects" on Lamictal, and is therefore switched to AtraZeneca's Seroquel, and gets better.

Oh, did I forget to mention that this article was funded by AstraZeneca, and that Seroquel was just approved by the FDA for the treatment of bipolar depression, and that AstraZeneca is in the midst of a major marketing campaign to encourage its use for this indication?

Now, let's conduct an autopsy of exactly how this CME article is biased in favor of the sponsor's drug. Case studies are a favorite technique used by medical education communication companies, because they are a way of spotlighting a particular product without appearing biased. Thus, apart from the case studies, this article is a fairly objective, if bland presentation of industry-supported treatment guidelines. The first case study endorses valproic acid and Risperdal, neither of which are in direct commercial competition with Seroquel, since Depakote is available generically and risperidone is a lame duck for Janssen, on the verge of going generic and being vigorously supplanted by Janssen's "new" Invega.

No, the money for AstraZeneca is in getting Seroquel prescribed in favor of arch-rival Lamictal, which is itself being vigorously promoted in a series of GSK-funded CME programs (see my review of one here). The second case study takes place in a bizarre parallel universe in which patients have more side effects on Lamictal than on Seroquel, exactly the reverse of what we psychiatrists commonly see here on Earth. Unrealistic, perhaps, but it serves the sponsor well, telling the story of a patient who likes Seroquel. We don't hear anything about Seroquel's famous side effect of sedation, because that would reflect poorly on the company footing the bill.

Aah, the feasts of summer. Now I have to sit back to build up an appetite for my next course. Luckily, the menu offers of plethora of choices.