September 5_ 2007 by domainlawyer


									Testimony of The Prescription Project
RE: 105 CMR 970.000: Pharmaceutical and Medical Device Manufacturer Conduct

My name is Marcia Hams and I am the Assistant Director of the Prescription Project. We appreciate this opportunity to offer testimony regarding 105 CMR 970.000: Pharmaceutical and Medical Device Manufacturer Conduct, which seeks to implement the ban on the provision of gifts from pharmaceutical and medical device companies to health care practitioners and requires disclosure of the payments made to health care practitioners. We applaud the Commonwealth and the Department of Public Health (DPH) for taking such significant leadership in addressing these critical issues. The Prescription Project, created by the Pew Charitable Trusts, is led by Community Catalyst, a national consumer organization based in Boston. The Project is focused on reducing conflicts of interest in the medical profession and expanding the use of evidence-based medicine to maximize benefits and minimize risks to patients. We are members of the Massachusetts Prescription Reform Coalition (MPRC) and also support initiatives in other states, at academic medical centers, and at the federal level. The goal of the Massachusetts Legislature in passing the gifts ban and disclosure law was to end inappropriate gifts and other inducements, and to ensure that consumers have full knowledge of their physicians’ and other prescribers’ relationships with pharmaceutical and medical device companies. Another aim of the Legislature was to protect patients of the Commonwealth and secure the success of health reform through implementing policies that support increased quality in prescribing as well as appropriate cost containment. In our opinion, the draft regulations should be strengthened to fully address the intent of the underlying statute: to protect consumers. Consumers must be assured that their doctors and other prescribers are making decisions in their best interests, based on unbiased, evidence-based information

that is not tainted by the marketing strategies of pharmaceutical and medical device manufacturers. In addition, consumers deserve protection from inappropriate industry marketing practices that drive up health care costs for individual consumers as well as public programs and all payers in Massachusetts. The Gift Ban Gifts and payments made to physicians inflate health care costs by leading to unnecessary prescribing of the highest cost and least proven drugs. It has been documented that 94% of physicians receive gifts and payments from pharmaceutical companies, according to a 2007 study in the New England Journal of Medicine. Some of these payments should be subject to a ban, while most others should be disclosed. While the Prescription Project welcomes the limitation on gifts as provided in this regulation, the current language is not sufficiently strong to curb the influence of this marketing technique, because:  Even small gifts create an expectation of reciprocity.  Decades of social science research—including studies on the effects of giftgiving to physicians—have shown that it takes extraordinarily little to create an involuntary sense of reciprocity in the recipient of a gift.  Drug companies would not expend so many resources on gifts and gift giving if they did not see a financial return on those investments. Furthermore, the proposed regulation only bans gifts for “sales and marketing”, not those given for educational and practice-related purposes, such as expensive textbooks, computers and models. However, these gifts serve the same promotional “reminder” purpose as other logoed giveaway items. It should be noted that the final version of the legislation in neither the House nor Senate exempted these kids of gifts to practitioners. The statute as passed only defines the minimum restrictions DPH may place on gifts to practitioners. DPH should choose to eliminate this corrupting influence and ban all gifts. Leaders in academic medicine are increasingly concerned about this issue, and many have recommended much stronger standards than we see in these proposed regulations.


 The University of Massachusetts Medical School and the Boston University School of Medicine—two of the leading academic institutions in the Commonwealth—have implemented policies completely banning the provision of all gifts and meals.  The Association of American Medical Colleges in a report released this summer recommended that within one year all academic medical centers should adopt strong policies banning food, gifts, and travel from drug and device manufacturers. The Public Health Council should consider both the abundance of empirical research on the influence and effectiveness of gifts and the opinions of experts within the medical profession and choose to craft regulations that ban all gifts to prescribers, including meals. Disclosure The Department of Public Health draft regulations should also be strengthened in the area of disclosure.  Payments made for research purposes are currently excluded. Given that research payments can reach into millions of dollars, it is imperative that the regulations require disclosure of all drug company payments to physicians, including compensation for research.  Full transparency will allow the state, the public, independent experts and academic institutions that employ physician investigators, to evaluate the overall impact of industry funding and payments as well as sort legitimate research funding from payments that may inappropriate. Marketing can also be disguised as research. A recent examination of Merck records has shown how a marketing strategy masquerading as research can have a devastating impact on health care outcomes.  In the case of Vioxx, the drug responsible for up to 120,000 cardiac events and 40,000-50,000 deaths, Merck involved 600 physicians in a Vioxx seeding trial—a clinical trial designed to introduce a medication to prescribers and build brand loyalty before market release of the medication.  The alleged research was revealed to be a sophisticated marketing tool.


 Such marketing strategies would be exempted from disclosure under these draft regulations. Current disclosure protocols and mechanisms to prevent conflicts of interest in research are not working. A recent report by the U.S. Department of Health and Human Services Department of the Inspectorate General, and highlighted in a New York Times editorial (both attached), found that:  Only 1 percent of doctors involved in clinical trials reported a financial conflict of interest in 118 marketing applications to the FDA by drug and device manufacturers in FY2007. In contrast, a national survey of physician-industry relationships published in the New England Journal of Medicine found that more than one quarter (28%) of physicians received payments from industry for consulting, giving lectures, or enrolling patients in trials.  In 42 percent of the applications the sponsoring company did not provide all the required financial information, potentially concealing conflicts of interest. In another example of failed disclosure policies that recently came to light, Dr. Charles Nemeroff, a prominent researcher from Emory University, has come under scrutiny for his failure to disclose drug company payments.  Although Emory has its own mandatory disclosure policy, Dr. Nemeroff failed to report hundreds of thousands of dollars he received from GlaxoSmithKline from 2000-2006.  During this period Dr. Nemeroff also headed a federally-funded research project studying Glaxo drugs. The grantor, the National Institutes of Health, requires that researchers not have financial conflicts of interest, but leaves the academic institutions to enforce it.  In this case, the reliance on the individual to report allowed the crucial information to remain undisclosed for years. Minnesota has had a comprehensive gift ban and law requiring public disclosure of payments for research and consulting for years. Examination of this data has revealed that payments for research and consulting purposes strongly correlate with prescribing practices.


 A New York Times analysis of Minnesota Medicaid data has found that during the period 2000-2005 psychiatrists who received at least $5,000 from atypical antipsychotic drug companies appear to have written three times as many atypical antipsychotic prescriptions for children as psychiatrists who received less or no money.  This analysis was only possible due to the disclosure law in Minnesota covering the most significant payments—those for research.  If Massachusetts had had a similar law, we would have known about the $1.6 million that Dr. Joseph Biederman of Harvard Medical School and Massachusetts General Hospital failed to disclose since 2000, much of it for research. Claims that the implementation of 105 CMR 970.000 will be detrimental to the biotechnology industry in Massachusetts are not supported by experience in Minnesota. Since Minnesota’s gift ban and disclosure legislation passed in the early 1990s, pharmaceutical industry jobs there grew by over 36%, compared with 19.7% nationwide. Indeed, policy makers in that state have not only kept this law on the books since 1993, they are filing a bill this year that would strengthen the law to include device manufacturers and eliminate virtually all of the exemptions to the disclosure requirements. The pharmaceutical and biotech industries’ arguments that the problems of conflicts of interest and inappropriate marketing will be solved by having their member and non-member companies abide by a mish-mash of self-imposed codes do not hold water. This approach is not sufficient to ensure a safe and conflictfree medical environment in the Commonwealth. It is unacceptable for each pharmaceutical and device company to police itself. Analysis of disclosure data collected from Minnesota and Vermont has revealed that previous versions of PhRMA’s code were violated and not enforced. Thus, to create a level playing field and ensure that all companies abide by a strong and enforceable code of conduct DPH should deliver a set of regulations that is stronger than self imposed codes of conduct set by industry. Massachusetts and Minnesota are not alone in taking action on this issue. Maine, Vermont, West Virginia and the District of Columbia have physician payment reporting laws, and many more states have and are expected to introduce legislation addressing the problem this session.

A federal bill, the Prescription Payment Sunshine Act, introduced in 2008 by Charles Grassley and Herb Kohl is also likely to be reintroduced in this legislative session. The pharmaceutical industry itself supported a version of this legislation last year that included disclosure of most payments to physicians, including research. We cannot speculate on the likelihood of passage of a federal bill or its scope, however, and thus it is in the best interests of the Commonwealth for the Public Health Council to implement strong disclosure regulations in Massachusetts now. The potential and already realized contributions of disclosure laws, such as Minnesota law and the Prescription Payment Sunshine Act, on quality of care and cost containment have been recognized in proposals for national health reform as well.  Senator Max Baucus’ recent white paper on health care reform and the Medicare Payment Advisory Commission have both recommended the disclosure of industry payments to prescribers as a way to ensure transparency and quality while controlling costs.  In support of this strategy, a December 2008 Congressional Budget Office options paper on health care recognized the potential of such disclosure to reduce spending over time. We are pleased that Massachusetts is continuing to lead the way in a national movement towards better health care, improved safety, and increased value. We encourage the Public Health Council to strengthen the draft regulations in order to ensure that consumers receive the most appropriate and valuable medicines. Thank you for your consideration and attention. The Prescription Project is available if you have any questions. Please contact me at 617-275-2889. Yours sincerely, Marcia Hams Assistant Director, The Prescription Project 30 Winter Street, Floor 10 Boston, MA 02108

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