The problem of conflicts of interest between the pharmaceutical industry and prescribing physicians
The Prescription Project seeks to ensure that “industry-physician relationships are free of conflicts of interest and that physicians base their prescribing decisions on accurate and unbiased information.” Recent events such as Merck’s withdrawal of Vioxx after aggressively promoting its use to physicians and consumers and an FDA warning on GlaxoKlineSmith’s heavily promoted diabetes drug Avandia have focused public attention on the ways that the drug industry promotes its products.
The Prescription Project was founded in 2007 to encourage new approaches to ending conflicts of interest. In combination with a team of academic researchers, two of the project’s directors published an article on the problem of conflicts of interests between industry and physicians in the Journal of American Medical Association . Community Catalyst, a national non-profit health care advocacy organization, founded the Prescription Project in partnership with the Institute on Medicine as a Profession, a research center at Columbia University with funding from the Pew Charitable Trust. Jim O’Hara, the managing director of policy initiatives at Pew, explained the rationale for the Project, “If you’ve been in the waiting room when these Chinese lunches are taken into the back office, it may raise the question whether the decisions are based on the best scientific evidence about medication or whether or not those Sichuan shrimp have something to do with the prescribing patterns” . The pharmaceutical industry spends $7 billion dollars per year marketing to doctors and another $18 billion on samples for physicians and patients .
Research and Policy Guidance for Academic Medical Centers and Government
By conducting research on the influence of pharmaceutical marketing on physician prescribing behavior, The Prescription Project provides evidence to guide policy recommendations for medical institutions. The group also conducts case study investigations of Academic Medical Centers (AMCs), seeking to understand the impact of its suggested guidelines. For example, if such studies show that the pharmaceutical industries continue to support drug research in institutions that impose guidelines, other institutions may overcome their resistance to change. Already several medical centers, including those at Yale, the University of Pennsylvania, Stanford and the University of Michigan have implemented or announced restrictions on drug industry marketing to their physicians.
The Project also seeks to influence national policy on conflict of interest rules such as the Physician Payments Sunshine Act recently introduced to the Senate . Charles Grassley (R-IA), co-author of the Sunshine Act, recently told the New York Times ”Right now, the public has no way to know whether a doctor’s been given money that might affect prescribing habits” . Media coverage of these proposals offers the Prescription Project an opportunity to influence the national debate .
The Prescription Project also advocates at the state level, urging legislatures to follow the precedent set by states like Maine, Vermont and New Hampshire that have passed prescription confidentiality legislation . Though the law has been overturned and is now being fought in appeals court, New Hampshire’s 2006 Prescription Confidentiality Act was the first of its kind .
Prescription Project Critics
The Project has attracted criticism both from the pharmaceutical industry and physicians. Critics within medical institutions argue the Prescription Project’s guidelines to reduce conflicts of interest are unnecessary because physicians do not make decisions based on “pizza and pens,” as Harvard Medical School hematologist Thomas Stossel is quoted saying in a recent Lancet article . Stossel is concerned that restrictions on interactions between the drug industry and physicians could obstruct the biomedical advances that have come out of collaborative research partnerships .
The drug industry insists that the guidelines the Prescription Project proposes are unnecessary. Ken Johnson, senior vice president at the Pharmaceutical Research and Manufacturers of America, said, “A new law is not necessary when pharmaceutical marketing is already heavily regulated by the Food and Drug Administration .” In addition, the American Medical Association, which received more than $46 million for its 2005 sale of data on physician prescribing practices , has yet to take a position on the federal proposal . (See box below).
Despite those who feel that guidelines on industry-physician relationships are not needed, studies show that free samples and meals, gifts, funding for travel and lodging, continuing medical education, research funding, and honoraria funded by pharmaceutical companies do influence physician prescribing and professional behavior . Social and psychological studies indicate gift-giving can bias decisions about patient care and create an unspoken reciprocity agreement wherein physicians are obligated to prescribe the products most heavily marketed to them [12, 13]. This situation not only creates real or perceived conflicts-of-interest, but may also increase overall drug spending .
Beyond voluntary guidelines
Based on this evidence  and its own research  on the psychological dynamics of industry marketing, the Prescription Project believes that voluntary guidelines will not prevent conflict-of-interest . They recommend instead the prohibition of industry-physician interactions . The Prescription Project’s Executive Director, Robert Restuccia, commends AMCs, such as Boston Medical Center and Boston University School of Medicine, which have taken up the groups recommendations because they “recognize the harmful impact of pharmaceutical marketing—it undermines better patient care, increases our nation’s health care costs and ultimately decreases confidence in physician independence” . For The Prescription Project, AMCs serve as model institutions for strict mandates because of their ability to adopt change quickly and instill medical ethics in coming generations of medical providers.
For more than 65 years, the American Medical Association has been selling pharmaceutical companies the Physician Masterfile, a database that contains information on the prescribing practices and other characteristics of 900,000 practitioners, most of whom are not AMA members . Most physicians are unaware of this practice. The drug companies then use data mining techniques to understand the profiles of prescribers of their products and provide pharmaceutical sales representatives, “drug detailers”, with the guidance needed on how best to approach individual doctors. The Prescription Project has collaborated with the National Physicians Alliance and American Medical Student Association to demand an end to the sale of this information to pharmaceutical companies and better protection of physician privacy.
Data mining is a big business for data collection companies such as IMS Health Inc., Plymouth Meeting, Verispan L.L.C., Wolters Kluwer Health. These businesses combine physician data with pharmaceutical prescribing data from pharmacy chains and other prescription sources to form complex physician profiles. The data mining groups then sell the hybrid information to drug companies, which in turn, create specialized marketing efforts directed at individual providers. The AMA insists the sale of the Masterfile is strictly for “licensure,” the legitimate process of verifying credentials and maintaining continuing medical education efforts , but the hefty profit its sale turns each year and the failure of the society to inform practitioners of the practice, has led many to call for policy change.
At the annual AMA meeting in Chicago this past summer, physicians engaged in the conflict-of-interest problem spoke out against the AMA’s relationship with Pharma interest groups. A member of the National Physicians Alliance, Dr. Ben Schaefer said he understands the necessity of physician prescribing data for research and continuing education, but states, “As a physician, I want my prescription information to be protected from commercial exploitation” . Three states have passed legislation that either prohibits data mining or allows physicians to make their own privacy decisions, but in each case, data mining companies have sued.
Drug companies argue the data mining restrictions violate commercial free speech and threaten public health research. Chief Executive Director of Wolters Kluwer Health, Jeff McCaulley, admits “It’s true that the pharmaceutical sales reps were using these lists to target high-prescribing doctors,” but he says the pharmaceutical industry has changed its practices and is now more “responsible” with physician data . Despite these claims, pharma interests have vowed to take legal action against any similar measures.
The Prescription Project has taken on a role as watchdog on the data mining issue. Legal council, Sean Flynn, noted that “the incorporation of prescribers into the commission structure of pharmaceutical sales incentives debases the medical profession, and, the more the practice becomes public, (the more it) breaks the chain of trust between doctor and client” .