After completing your medical residency at Mass General in 1995, what was the nature of your practice and academic authorship prior to your involvement with Wyeth Pharmaceuticals?

After my residency I went into a combination of private and hospital-based practice as an inpatient attending at Anna Jacques Hospital in Newburyport, MA. During that time, I built up a private practice, also in Newburyport, and got involved in writing and editing textbooks for psychiatrists. I wrote a textbook called the Psychiatric Interview: A Practical Guide, which was published by Lippincott Williams & Wilkins, and started a series of short practical guides on different aspects of psychiatric practice that would be useful for residents, early career psychiatrists, and anybody that needed a quick, handy reference book.

Can you briefly describe your involvement with Wyeth Pharmaceuticals and how that led to your current views on the industry-physician relationship?

I was approached in 2002 by a representative from Wyeth who asked if I would like to be a promotional speaker for the company. I accepted his offer and went to the speaker training meeting held in New York. After that I gave talks for primary care doctors, primarily on antidepressants and the management of depression, always with the focus on the drug Effexor. Ultimately, I found that the problem with giving those talks was that, because I was paid so much–about $750 for about an hour long talk–I felt a subtle pressure to highlight the positive aspects of Effexor and to downplay any of the negative aspects, side effects, or other liabilities of the drug. Because of that feeling, I ultimately decided to quit the speakers bureau.

What events stand out in your mind in the development of the prescription culture associated with the practice of psychiatric medicine?

Probably the first big event that stands out in my mind was the introduction of Prozac as an antidepressant in 1988, which very quickly became a blockbuster because, not only was it effective for treating depression, but it had very few side effects compared to some of the other antidepressants available at that time. Shortly after Prozac was introduced, a fascinating book was written by a psychiatrist at Brown University, Dr. Peter Kramer. ¹ Dr. Kramer described that patients he treated with Prozac not only benefitted from the antidepressant action of the drug, but experienced positive personality transformations as a result of its use. For example, patients who had previously exhibited hesitant or shy personalities would come out of their shells and were very comfortable with other people. The book enhanced the popularity of Prozac and motivated other drug companies to create their own competing products to Prozac; since Prozac’s introduction at least ten ëme-tooí versions of Prozac have been developed over the years. Almost every similar drug has become a blockbuster in its own right, not because they were any more effective in treating patients, but as a result of their demand induced through the marketing machinery of the drug companies which made many of these drugs best sellers.

The Carlat Psychiatry Report, which you publish, offers its physician readership CME content independent of industry influence. Why did you feel another journal would be an effective vehicle for addressing what you have referred to as a ‘corrupting’ influence? How would you characterize the response of the medical community?

I came up with the idea of creating another publication during the time I was speaking for Wyeth, toward the end of 2002, as I became more and more uneasy with the promotional nature of my talks. I noticed that many of the publications sent to me in my private practice office were funded by drug companies. I don’t mean simply that the drug companies put ads in journals, but some journals and newsletters actually appeared to be wholly commissioned by drug companies that would hire medical communication companies to produce the journals. In some cases, well known academic doctors were paid simply to put their names on articles that were in fact ghostwritten by anonymous medical writers. It bothered me, because I, as a practicing doctor, am always looking for good comparative effectiveness information in treatments and yet so much of the literature in some ways was influenced by drug company promotional messaging.

How might the influence of industry biases affect patient outcomes?

My impression is that the promotional programs and the CME programs funded by drug companies have emphasized the newest drugs, which are not always necessarily better for patients. In psychiatry, which is a somewhat different field in this regard from some other areas of medicine, many of the newer drugs have actually not been any better than older drugs and have had various disadvantages that have been downplayed. Well how does that affect patient outcomes? Iíll just give you an example from the antipsychotic market: Zyprexa is a new antipsychotic, which was created by Eli Lilly ñincidentally the same company that marketed Prozacñ which was marketed as a big advance in antipsychotic treatment. But what was downplayed in the marketing, at least initially, was the fact that Zyprexa can cause enormous weight gain in patientsÖ as much as one pound per week of treatment. So we were beginning to see our patients gain weight on Zyprexa. Obesity, in turn, leads to a number of other problems such as diabetes and cardiovascular disease. So my concern is that in cases like Zyprexa, the over-hyping of some of these newer agents has led to negative instead of positive outcomes.

What roles do CME providers including Medical Education Communication Companiesî (MECCs) play in this?

The role that MECCs have played is that they have supercharged an entirely new form of pharmaceutical advertising-industry-funded CME. This has over the last decade gone from being about a $300 million per year to a $1.2 billion per year industry.2 What that means is that the drug companies pay grants to the MECCs to put on CME programs for doctors and then the MECCs, knowing the marketing messages the drug companies are trying to convey, hire doctors, who they already know have bought into those particular marketing messages. Those doctors will then give talks or write articles which are usually subtly biased in favor of the sponsorís product.

In addition to statements in the Annual Report of the ACCME indicating the decline of Industry funds for MECCs2, how do you interpret the change going on at the levels of the APA, AMA3, and drug companies themselves?

What has happened over the last couple of years is that the issue of drug company bias in education programs has come front and center, due to a number of developments. In some cases there have been high profile physicians, some of whom have been psychiatrists, orthopedic surgeons, and cardiologists, doctors who have been caught not disclosing millions of dollars in payments received from drug companies. This has caused very bad publicity for those doctors, the universities with which they are affiliated, and for some medical societies. In turn there have been institutional reforms, where, as in the case of the APA, the association has decided that it will no longer allow drug company-sponsored courses at its annual meetings. And that is only one example, but when you multiply that by other medical societies and academic medical centers, this has resulted in a $200M decrease in industry funding of CME from 2007 to 2008. ²

Among others, Senator Grassley (IA-R) has recently been involved in exposing conflicts of interest between the medical and research communities and the pharmaceutical industry. What role do you think he has played in bringing this issue into the public sphere?

Senator Grassley has become interested in the influence of drug companies on medical practice, because he found that a number of high profile doctors that had received publically-funded NIH4 grants for research were at the same time giving promotional talks for the very same drug companies that would benefit from the NIH grants. That in itself is a bad enough conflict of interest, but what made it worse was that many of these same doctors had not disclosed the funds or payments they had received from drug companies. In some cases, these payments ran into the millions of dollars over the course of several years. These kinds of disclosures have encouraged journalists, bloggers such as myself, and attorneys to look into the behaviors of drug companies and doctors, which has led to large legal settlements in which companies have admitted to illegally marketing some of their products. The largest such settlement was the recent Pfizer settlement for $2.3 billion. ⁵

These settlements may sound large, but in fact $2.3 billion is not really a lot of money for a company like Pfizer, which makes about that much in income every three weeks. The financial penalties are little more than slap on the wrist for the large companies. But a more significant result of the settlements is that the companies are required to sign corporate integrity agreements, which are blueprints for how they must reform their promotional practices. They will also be required to report the oversight activities of their marketing programs to a certain authority on a regular basis. That I think is the real contribution of some of these settlements.

You have made it a point that health-related institutions need to be actively scrutinized, openly criticizing institutions you have been involved with when they receive pharmaceutical money, show lapses in transparency, or suppress independent voices. Tufts is no exception. Recently Tufts University rescinded an invitation to Paul Thacker, a member of Senator Grassley’s staff, originally invited to be a keynote speaker on conflicts of interest in medicine and research, due to an ongoing inquiry from the Senator’s office regarding a Professor at Tufts University Medical School. ⁶ Can you explain to our readers what you think Thacker would have brought to the discussion?

Paul Thacker, while he now works for Senator Grassley, was an investigative journalist prior to taking that position, famous for having written some very high profile articles for different magazines on issues like the way tobacco companies had created certain scientific findings in order to convince consumers that tobacco is not really dangerous. Thacker is known for his expertise in writing about the ways that large corporations have manipulated science in different fields, not just medicine. For that reason I think he would have been an excellent addition to the program, simply because of his breadth of experience. He can talk about the ways that drug companies manipulate science and doctors, but can also talk about how companies in other fields have done things and used techniques that drug companies might have borrowed. I think the Tufts community missed out on some great education by preventing him from speaking.

You recently submitted written testimony before the Senate Special Committee on Aging regarding Industry influence on doctors. ⁷ Currently, we have a patchwork system of regulation that varies state to state. Do you see a future for efforts to regulate this at the federal level, especially now within context of the healthcare reform debate?

I would say that my reading of the Senate and the entire Congress in terms of these issues is that there is broad support for increased transparency. One component of the current healthcare reform bill is something called the Physicians Payment Sunshine Act, which would require on the national level all drug companies to post on the internet all payments they make to doctors, particularly for any marketing or consulting. ⁸ Is that going to reform to any degree companies that are inducing doctors to do this? I would think so, because when you know that the payments of thousands and in some cases millions of dollars you receive are going to be published on a public website that anybody has access to, you are going to be a little more cautious of what you are doing to gain that money. I think what will happen is that fewer doctors will be willing to give blatantly promotional talks. You will have doctors that perhaps decide to do research or consultation for a drug company to help them in developing a product or designing research, which in my opinion can be entirely appropriate, but it really is not okay to become a drug representative and give talks to drive up drug sales.

Lastly, I wanted to hear your reflections on the debate about ghostwriting in biomedical literature and the relationship between research, the practice of medicine, and the influence of the industry.

Ghostwriting continues to happen. It’s a practice that has been rampant in science, and in psychiatry in particular, there have been estimates that up to half of all articles written about certain medications were actually ghostwritten rather than written by the identified authors. Recently there have been estimates that that about 10% of all articles in bigger journals are still ghostwritten. Because of the publicity and the increasing transparency about what ís happening, journal editors are putting policies in place to prevent ghostwriting from occurring; essentially they are saying if you submit an article with your name on it, they want to know what you did to write the article and if anyone else was involved, from now on you must divulge who it was and who paid them, such as if they were paid by a drug company.

References

1. Kramer, Peter. Listening to Prozac: A Psychiatrist Explores Antidepressant Drugs and the Remaking of the Self. (1993)

2. ACCME Annual Report Data 2008. Accreditation Counsel for Continuing Medical Education. (2009) Available at: http://www.accme.org/dir_docs/doc_upload/1f8dc476-246a-4e8e91d3-d24ff2f5bfec_uploaddocument.pdf

3. American Medical Association

4. National Institutes of Health (US Dept. of Health and Human Services)

5. Winslow, Ron. ìPfizer Sets $2.3 Billion Settlement: Agreement with U.S. Tied to Alleged Off-Label Marketing of Painkiller Bextra. The Wall Street Journal. January 27, 2009. http://online.wsj.com/article/SB123301757444517869.html

6. Silverblatt, Rob. Committee rescinds informal invitation to staffer for Sen. Grassley.î Tufts Daily. March 31, 2009. http://www.tuftsdaily.com/news/committee-rescinds-informalinvitation-to-staffer-for-sen-grassley-1.1635572

7. Carlat, Daniel. Testimony before the Senate Special Committee on Aging. July 29, 2009. Available at: http://aging.senate.gov/letters/carlatcme.pdf

8. S 301: Physician Payments Sunshine Act of 2009. THOMAS. Library of Congress. Available at: http://thomas.loc.gov/cgibin/query/z?c111:S.301: