University COI Policies and Generic Drugs – The Old Becomes New
A recent study from the Perelman School of Medicine at the University of Pennsylvania revealed that psychiatrists who were exposed to conflict of interest (COI) policies during their residency were less likely than peers who lack similar training to prescribe brand-name antidepressants, “which are heavily promoted to psychiatrists and tend to be more expensive,” the study claims. The study claimed that a “dramatic increase in prescription drug use,” and relationships between pharmaceutical representatives and physicians have “come under extensive scrutiny both within the medical profession and by policy makers.”
“Our study clearly shows that implementation of COI policies have helped shield physicians from the often persuasive aspects of pharmaceutical promotion,” first author Andrew Epstein stated in the press release. The results will be published in the February issue of Medical Care. Some have speculated that if the results are correct, we may begin to see an even stronger increase and flurry of COI policies at academic medical centers, although most already have strong policies in place.
What may change, however, is the emphasis that certain professors or programs place on teaching and training young physicians on COI policies. This will be troublesome in some cases where the instructor has a negative view of industry and discourages industry relationships or collaboration—which may lead to a generation of physicians who do not work with industry. We have previously reported that physicians who refuse to see pharmaceutical sales reps were less likely to be aware of important risk information and new clinical data.
The study focused on antidepressants because “they have been among the most heavily marketed drug classes,” Epstein said. “Data show that antidepressant use increased nearly 400 percent from 1988 to 2008. The goal for this study was to determine whether exposure to COI policies during residency would influence psychiatrists' antidepressant prescribing patterns after graduation.”
Penn Medicine in 2006 implemented policies placing restrictions on physician interactions with pharmaceutical representatives. In 2008, the Association of American Medical Colleges (AAMC) developed COI policy guidelines for gifts, free meals, and medication samples provided by pharmaceutical representatives to physicians and trainees. “The concern was that these interactions could influence clinicians to prescribe brand medications even if they were more expensive or less suitable for patients than generic alternatives.”
To assess the effects of COI policies on physicians’ prescribing patterns after residency, the research team examined 2009 prescribing data from IMS Health for 1,652 psychiatrists from 162 residency programs. The physicians fell into two categories: about half graduated residency in 2001, before COI training guidelines were implemented, while the other half graduated residency in 2008, after many medical centers adopted COI policies.
Physicians were also categorized based on the restrictiveness of the COI policies adopted by their residency programs' medical centers. Results of the study show that, although rates of prescribing brand antidepressants, including those that were heavily promoted and brand reformulations, were lower among 2008 graduates than 2001 graduates in general, the rates were lowest for 2008 graduates of residency programs with very restrictive COI policies. Such results are hardly surprising given the fact that academic medical centers with very restrictive COI policies likely restrict almost all access by industry on their campuses and strictly limit any kind of off-campus interactions with industry—making it almost impossible for the 2008 graduates to ever learn about brand-name drugs.
Another factor that the study might not have taken into consideration is that a number of the antidepressants likely went off-patent during this time frame so that pharmacies would have had to fill a brand-name prescription with a generic regardless, unless the physician specifically instructed otherwise.
Additionally, the study did not attempt to measure patient or clinical outcomes. In other words, there was no discussion or evidence that patients being prescribed brand-name drugs did worse than those on generics or had any more adverse consequences. Moreover, as the study recognized, there can easily be many other differences and factors between two groups that are 7 years apart—e.g., increased medical literature; advances in research and clinical data; postmarket safety reports; changed, revised or new guidelines, and so on.
Part of the motivation behind the study, as Epstein recognizes, is the high cost of brand-name medications and anti-depressants, particularly because patients must take these pills multiple times a day, for long periods of time—years, even decades. Accordingly, the study may be seen by some as an argument to help reduce healthcare costs. Yet Epstein cautioned that lower costs achieved through stringent COI policies may come at a price.
“Contact with the pharmaceutical industry may have important informational benefits for physicians. And, by exposing trainees to industry representatives, we may be helping them prepare to navigate these relationships after graduation,” said Epstein. “Nevertheless, while these relationships may be useful in some ways, our study clearly shows that implementation of COI policies have helped shield physicians from the often persuasive aspects of pharmaceutical promotion.”
Epstein notes that in future research it will be critical to assess whether these policies have similar effects on other drug classes and physician specialties.
As we have mentioned before, educating young physicians and physicians in training about COI policies and interactions with industry and pharmaceutical sales representatives is a noble goal and one that should be taken seriously. However, allowing those faculty and medical school staff who are already critical of industry and have their own personal biases about industry to educate impressionable minds is problematic. There needs to be balance when educating medical students and residents about COI policies and relationships with industry. There must be an equal voice for industry so that students can understand the critical and crucial relationships that physician-industry collaboration brings to medical innovation and progress.
If future research is to be conducted on COI policies, such research should evaluate the extent to which such policies adversely affect physician industry relationships, and how such adversity can harm patient care and decrease good patient outcomes. Moreover, schools with COI policies must ensure that those responsible for training and educating students about COI policies give a fair and balanced presentation of industry relationships.