A response to “Dollars for Docs.”
To the Editor:
Patients and academic medical centers have an interest in understanding the symbiotic relationship between clinicians and scientists and the for-profit healthcare industry. Given past history and human nature, a fire wall between the two groups might seem expedient. However, such a draconian approach ignores the healthcare industry’s need for guidance from clinicians and scientists with respect to disease pathogenesis, potential therapeutic approaches and assistance in clinical trials, while clinicians and scientists need for access to proprietary pharmaceuticals, other reagents and research data to inform their own research, as well as the possibility of conducting investigator-initiated clinical trials or participating in pharmaceutical company-initiated clinical trials.
Many checks and balances already exist to avoid conflict of interest on the part of both groups. The FDA monitors pharmaceutical company advertising and educational material to prevent false claims; academic institutions impose strict reporting requirements and rules on their faculty to avoid conflict of commitment or conflict of interest, including a ban on participation in “speaker bureaus” and a firewall between investigators and their research whenever potential financial gain is involved. The FDA, scientific societies and scientific journals have their own conflict of interest rules and ghost authorship is forbidden.
However, there are unintended consequences of these worthy endeavors to impose morality. The accreditation requirements to avoid the possibility of conflict of interest in continuing medical education programs are so rigorous that the expense and paper work involved has led to the discontinuation of these programs by some. The FDA’s requirement that outside advisors have no contact with pharmaceutical companies for at least three years has led to situations where these advisors lack the knowledge and expertise to exercise the necessary judgement; certain medical journals have the same rules, which limits their choice of informed editorialists.
The physician payment data base now adds the missing link of “follow the money” to conflict of interest transparency. The manner of implementation is, however, understandably problematic because the payment data base is unannotated with respect to the basis for a stipend. For example, receiving remuneration for serving as a consultant or on a drug company advisory board is not the same as receiving a financial incentive for using the products of a particular manufacturer, which is the modern equivalent of fee-splitting. In response, academic institutions schools have stipulated a dollar threshold, for example, $25,000, above which there is a concern about both conflict of interest and conflict of commitment.
I agree with the need for transparency and strict scrutiny to maintain public confidence in academic medicine and the healthcare industry. To avoid conflict of interest, neither I nor my family own stock in any company for which I consult. I have never belonged to speaker bureaus, and for paid lectures, I use only my slides and will not permit content to be dictated or changed by any company. Others will surely choose other solutions to this issue, but for me, given the lack of familiarity of uncommon diseases like the MPN amongst pharmaceutical companies, many physicians and the FDA, educating these constituencies is an appropriate and important priority.
There is, of course, another side to this issue, which is the public’s responsibility. Patient advocacy groups can also be guilty of conflict of interest. For example, a few years ago, when I and my colleagues sought to convince the National Cancer Institute that the MPN were disorders worthy of study, I was contacted by the leader of a patient advocacy group, whom I had never met or even communicated with, who informed me that her group did not support our efforts and she would prevent any of that group’s members, who had expressed such an interest, from doing so independently. Fortunately, she did not prevail.
So who is watching the watchers? I also think it is ironic that patient advocacy groups, whose mission is to foster new pharmaceutical development for their diseases, are now expressing concerns about the involvement of their physicians in the very activities they are promoting. If patients trusted their physicians before, it is unclear to me why they should suddenly become mistrustful now; though, evidently, transparency appears not to be enough.
Finally, conflict of interest shouldn’t be a major issue in the MPN since there is only one new FDA-approved MPN-specific pharmaceutical, whose use is not office-based, is subject to FDA guidelines and is also monitored very closely by medical insurers because of its expense; it also happens to effectively alleviate symptoms and prolong survival in contrast to the currently most commonly used drug.
Jerry Spivak, MD
Professor of Medicine and Oncology
Director, Center for the Chronic Myeloproliferative Disorders
Johns Hopkins University