Over the next few days we will be posting articles based on a series of lectures that were presented at Harvard University earlier this year. They represent the two views of industry relationships (pro and con) and an additional view from a carrier bureaucrat calling for more stringent regulation.
Harvard University’s Edmond J. Safra Foundation Center for Ethics has conducted a lecture series focused on Institutional Corruption. In December, Marcia Angell-Relman, M.D., the first woman to serve as acting editor-in-chief of the New England Journal of Medicine (NEJM), gave an hour lecture which focused on conflicts of interest (COI) in academic medical centers (AMCs), and continuing medical education (CME). After the lecture, she responded to questions from the audience, which consisted of numerous Harvard faculty.
Introduction
Dr. Angell began her lecture by noting an article she wrote in May of 2000 titled, “Is Academic Medicine For Sale?” The article focused on the clinical trials of an anti-depressant Serzone, and the authors of a paper who had financial conflicts who apparently had financial disclosures that would “have been as long as the paper.”
She used this as an example of the “hardly unique” occurrence of physicians in AMCs being paid for work by pharmaceutical companies. She cited that nearly 94% of physicians take money or gifts from drug companies, and that many are paid speakers, consultants, and authors of papers.
It was clear from the onset of her discussion, that her one sided approach would be a critique of drug companies involvement in the work and research of physicians in AMCs, instead of a balanced consideration of the risks and benefits.
Drug Industry
Dr. Angell’s concerns stemmed from drug companies that subsidize meetings and CME; doctors who are reimbursed for attending those meetings and programs; and the billions of dollars industry uses each year to “influence the way doctors use drugs.” Contrary to her claim, a recent article in the Journal of Academic Medicine found that to date, “no published studies have addressed the relationship between commercial support and perceived bias in accredited CME activities.”
Part of her worry about the relationship between academia and industry is that the goals and missions of AMCs are being blurred. While she sees the mission of AMCs to educate the next generation of doctors, partake in important research, and take care of the sickest and neediest patients, she sees drug companies only out to increase shareholder stock.
She goes even as far as saying that drug companies do not seek to educate doctors because they do not have education budgets, they have marketing budgets.
The lecture then moves to clinical studies, which Dr. Angell claims are used by companies to get their drugs used for other uses, to show advantages of their treatment over another, or to get physicians to prescribe their drug. What exactly is wrong with companies wanting doctors to prescribe their drugs to help patients, and to show the advantage over another treatment? This claim is especially disturbing because as Dr. Angell herself explains, all clinical trials are required to have FDA approval, and must show the drug is reasonably safe and effective compared with a placebo. With this kind of oversight, where is the conflict?
Dr. Angell believes that when drug companies contract with AMCs to conduct clinical trials, the potential for COI is significant. She explained that until the mid 1980s, drug companies gave research grants to AMCs to run trials that were investigator initiated, and that the researcher thought was scientifically or medically important. At that time, she noted that drug companies had no part in designing studies, did not own data, or write papers, or control publication. Today however, Dr. Angell is concerned because she thinks this kind of relationship no longer exists.
She associates part of the influence from the fact that the drug industry has enormous power and influence, and because AMCs have fallen on difficult times, mainly from shrinking reimbursement on clinical trials and treatment. It would therefore seem that industry is providing tremendously important clinical experience to researchers, that otherwise might not be affordable for the AMC to partake in.
But Dr. Angell sees drug companies using AMCs to increase their chance of getting work published on their drugs because it gives the companies access to highly influential professors, known as Key Opinion Leaders (KOLs), who write textbooks, journal articles, sit on FDA panels, etc.
Conflict of Interest
Dr. Angell proposes a radical COI policy because present COI rules are highly variable, highly permissive, and loosely enforced. She notes that at Harvard, no COI is flatly prohibited only limited in various ways. She believes such policies are loose because AMCs don’t want to lose their “stars,” who are custom to supplement income with deals with industry.
She associates part of the problem with AMCs and industry to the Bayh-Dole Act of 1980. This legislation permits, but does not require, universities to patent studies from government funded research and then to license them to companies in return for royalties. Similar legislation exists for work done in NIH. She acknowledged that “industry and academia are partners, both benefiting from public support.”
Dr. Angell noted that the original purpose of the act was to speed the discovery stage to practical use, but she believed that it was eventually used improperly to increase the number of patents, and not their quality. She noted that a number of schools now have technology transfer offices to deal with the results of new patents and licensing. How does this kind of partnership, both benefiting from public support, constitute a COI?
The cause of her concern is that she sees industry setting the research agenda in AMCs, which is focusing too much on targeted applied research and drug development, not causes, or mechanisms or prevention of disease. She is also worried about drug companies using AMCs to carry out studies for entirely commercial purposes, for example pitting 2 drugs against each other.
Although she believed that it is important that researchers have no financial stake in the outcome of their research, she did not object to all collaboration between academia and industry. Her main objection was only to terms and conditions that pose real threats to the independence and impartiality of medical research.
At one point, she even asserted that “collaboration between academia and industry can be fruitful, but only if it doesn’t need to involve payments beyond grant support.
Continuing Medical Education
Dr. Angell believed that the influence of industry is perhaps the greatest in CME, and has the least justification because they just want access to the best medical schools and young doctors to influence their prescribing habits. The problem with this assertion is that she forgets the role ACCME plays in accrediting Medical Education Companies, and the guidelines which make programs free from drug company influence.
Her biggest argument against industry funded CME is that if it were really education, the doctors “would pay them for their services.” The added cost of travel, lodging, food, expenses associated with leaving the practice, and other considerations make paying for CME extremely difficult, especially when programs are not evenly dispersed geographically. Additionally, she thought it was “absurd to look to drug companies for critical unbiased education about products their selling,” which was akin to looking to a beer company to for information about alcohol education.
Seemingly, she believes that the one thing doctors do learn from CME is to practice drug intensive style of medicine, even when changes in lifestyle would be more effective. This includes being “convinced that the newest most expensive drug, is the best treatment, even though older or generic drugs are available.” Ultimately, she believes that industry has no legitimate in role in CME, and it should be the responsibility of the profession.
Recommendations
In closing her discussion, Dr. Angell noted that although “industry-academic collaboration can make meaningful scientific contributions, it does not necessitate a personal enrichment of doctors or researchers. She recommended that:
1) Medical school faculty who conduct clinical trials should not receive any money from the drug companies except for research expenses. That support should have no strings attached, no control over design, publication. Faculty should also not enter deals of products faculty are studying’
2) Doctors should not except gifts from industry, and should pay for own meetings and CME; and
3) AMCs that patent discoveries should put them in public domain or license them nonexclusively, like Stanford.
Dr. Angell also noted that medical journals should not publish papers whose authors have other ties to sponsors of researchers. She also asserted that while disclosure is better than nothing, she believes it does not eliminate conflict, it only passes the burden to someone else. After her speech she went on to take questions from members of the lecture, mostly Harvard faculty from other schools.
Opinion
A one sided lecture such as Dr. Angell’s is extremely difficult to value since it merely attacks industry, without giving industry a chance to defend itself, or to consider the numerous benefits associated with industry-academia collaboration. Such a narrow focus on the few cases that COIs have existed only unnecessarily labels the successful relationships negatively. Some of the questions Dr. Angell addressed were concerned with her “radical” approach. Others were worried that changing the way industry and academia practice medicine could introduce a new type of COI, where the government tells doctors what to prescribe because they are merely trying to save money on government programs like Medicare.
Ultimately, an entirely different discussion that takes into account the benefits of academia-industry relationships is needed. This discussion should address some of Dr. Angell’s concerns about disclosure and COI, but should also focus on the importance industry-academia collaboration bring to developing new medicine, treatments and devices.
If you want to watch the lecture click here.
40% of the Lancet’s revenue comes from the sale of reprints of pharma trials. The NEJM refused to supply similar information. Sounds like Dr. Angell’s “Journal” was likely for sale as well.