Seton Hall University School of Law’s Leuven-Geneva Program in Health, Intellectual Property and International Law combines a broad-based introduction to the laws, policies and institutions of the European Union (EU) with a unique, interdisciplinary examination of cutting-edge issues in intellectual property, pharmaceutical development and global public health.
The Program will consist of two courses. European Union Law, a two-credit course, will be taught mainly at the Leuven Institute in Leuven, Belgium and will include a special trip to Luxembourg to visit the European Court of Justice. Students will also visit some of the main EU institutions in Brussels, such as the European Parliament and Commission.
The goal of this part of the Program is to introduce students to the essential principles and institutions of the EU and to explore firsthand the challenges facing this unique confederation of different languages and cultures. For the Geneva component of the Program, students will study Health and Intellectual Property Law in a Global Environment, a four-credit course, co-taught by one intellectual property law professor and one health law professor. The course will be conducted in collaboration with Geneva-based international organizations involved in health and intellectual property law issues, including the World Health Organization, UNAIDS, the World Trade Organization and the World Intellectual Property Organization.
Students will work on a series of case studies related to the work of these organizations, both in the classroom and in on-site meetings with organizational representatives. In addition to students from the Seton Hall Program, the Geneva component of the Program will also be open to students from the University of Zurich Ph.D. program in Biomedical Ethics and Law.
More information about the program is available here: http://law.shu.edu/Students/academics/studyabroad/Geneva/index.cfm
Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy has called for major substantive reforms in the financing and oversight of clinical research. In a White Paper entitled “Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” the Center proposes legal and policy changes to address conflicts of interest in the relationships between industry and doctors that can create unwarranted risks to trial participants and to the scientific integrity of research.
Kathleen Boozang, a dean who oversees the Law School’s Center, explains that “Some of the ways that drug and device trial sponsors pay the physicians who lead clinical trials can tempt them to recruit individuals for clinical trials who would be better off receiving conventional therapy. This is of particular concern if physicians encourage their own patients to enroll in trials that these same physicians are overseeing.”
Over 60% of testing of experimental drugs and medical devices now occurs in physicians’ private offices; unlike years past, industry funds a much higher percent of clinical trials than government, frequently paying researchers significantly more than government does. For some physician practices, conducting clinical trials represents a significant portion of their income.
According to Carl Coleman, a Seton Hall Law professor who collaborated on the White Paper, “A different kind of problem arises if people are enrolled in trials who don’t meet the criteria for who should participate - these individuals’ health can be put at risk, and their participation can skew the results of the trial, which is bad for everyone.”
Federal regulations in this area have not kept up with the rapid changes in how research occurs, and even those regulations that exist are poorly enforced, according to recent government studies. Understanding that the collaboration among industry, government, and medicine in the pursuit of clinical research is critical to driving scientific progress, particularly as industry increasingly replaces the government as the primary source of research funding, the Center’s recommendations include:
1) Establishing a norm of financial neutrality between treatment and research. Ensuring that physicians receive comparable compensation for treatment and research will help ensure that their decisions to conduct research, as well as to recommend that a particular individual participate in a clinical trial, are grounded in reasons unrelated to their personal financial interests. This will be best accomplished, in the first instance through regulations that ban certain kinds of research compensation, and provide examples of acceptable payment methodologies that industry can follow. Reform by prosecution signals what practices government dislikes, but does not provide a clear vision of ideal approaches to managing conflicts of interest related to the conduct of research.
2) Establishing federal guidelines as to the principles or methodology by which to determine fair market value of physician time spent in clinical work. Federal regulations should be promulgated that establish a benchmark formula for determining fair market value of physicians’ time, effort and expenses for clinical research. Such regulations would promote the goal of financial neutrality between treatment and research. Physicians cannot be underpaid for research either - compensation for clinical trial work should therefore include reimbursement for any additional expenses that are unique to the research environment.
3) Banning payments with equity interests; disqualification of investigators who hold direct interests in the outcome of the research. Federal regulations should prohibit compensation for research in the form of an equity interest in the sponsor of a clinical trial. The law should preclude researchers who have investments that give them a direct interest in the outcome of the research from leading clinical trials. Where absolutely necessary, such individuals might appropriately serve as consultants.
4) Banning payments of finder’s fees and bonuses for recruitment and retention of trial subjects. Certain forms of compensation create conflicts of interest that can incentivize investigators to enroll individuals in a clinical trial who are too healthy or too sick to participate, or to deemphasize information that might discourage individuals from consenting to trial enrollment. Federal law should ban such compensation methods, including finder’s fees and bonuses for meeting recruitment and retention goals.
5) Reforming federal regulations to compel and better guide the evaluation of relationships between industry and would-be physician investigators prior to the commencement of research. The White Paper includes overlapping but sometimes distinctive recommendations for federal regulation to evaluate and oversee investigator or institutional conflicts of interest, both for research within and without academic medical centers. Specific to research outside of academic medical centers, federal regulations should spell out clearly the obligation of community-based physicians acting as investigators or institutions acting on their behalf to report information about compensation for research and other financial interests to Institutional Review Boards.
Summarizing the importance of this White Paper, Boozang states, “The pharmaceutical and medical device industries save millions of lives each year with their innovations. It is imperative that we maintain the integrity of research, and the public’s trust in the process.”
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy. The Center is a think tank that fosters dialogue, scholarship, and policy solutions to critical issues in health and pharmaceutical law. As part of its mission, it convenes policymakers, consumer advocates, the medical profession, industry, and government in the search for concrete solutions to the ethical, legal, and social questions presented in the health and pharmaceutical arenas. The Center also runs a compliance training program covering the state and federal laws governing the development and marketing of drugs and medical devices. The White Paper, “Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” may be found here.
Seton Hall University School of Law, New Jersey’s only private law school and a leading law school in the New York metropolitan area, is dedicated to preparing students for the practice of law through excellence in scholarship and teaching, with a strong focus on clinical education. The Law School’s health law program has been ranked as one of the top programs in the country. Founded in 1951, Seton Hall Law School is located in Newark and offers both day and evening degree programs. For more information visit law.shu.edu.
Tags: Center for Health and Pharmaceutical Law & Policy, Clinical Research, compensation of clinical researchers with company stock, Conflicts of Interest, Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight, Health Care Reform, Health Reform, Seton Hall Law, Seton Hall University School of Law, Transparency, Transparency and Accountability, Transparency Medical Research
The American Society of Law, Medicine & Ethics (ASLME) and
Seton Hall University School of Law will co-sponsor the Third Annual Student Health Law Conference on Friday, October 16, 2009 in Newark, New Jersey, from 8:30AM to 5:00PM.
This conference, which is attended by law students from law schools throughout the country, seeks to expose law students to the myriad career paths for attorneys in health and life sciences. The conference provides an introductory session on health law, panels on a variety of employment opportunities in health law, and a networking reception with the conference speakers. Career paths that will be represented include academia, compliance, private firms, government agencies, nonprofit organizations, drug and device companies, health insurers, and hospitals. Speakers for this year’s conference have been chosen for their health law expertise and background.
The format of the conference is a series of panels focused around a particular kind of health law career. Each panel is approximately one hour long and comprised of two to four panelists. Students will have the opportunity to explore nontraditional employment opportunities across the health law spectrum, receive support and guidance from professionals familiar with the experience needed for various careers as well as recruitment and hiring processes, and network with health law attorneys.
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here for more information.
[Ed. note: mpp.org: "On February 23, the New Jersey Senate voted 22-16 to pass S119, also known as the New Jersey Compassionate Use Medical Marijuana Act. The Assembly health committee voted 8-1 to pass an amended version of the bill on June 4. It must now pass the full Assembly [If the amended bill clears the Assembly, it would return to the Senate for a second vote because of the changes] before it goes to Gov. Jon Corzine (D), who has said that he will sign the bill if it makes it to his desk.”]
Seton Hall University School of Law
Center for Health & Pharmaceutical Law & Policy
Statement In Support of the “New Jersey Compassionate Use Medical Marijuana Act”
The Center for Health & Pharmaceutical Law & Policy supports the passage of the New Jersey Compassionate Use Medical Marijuana Act (the “Act”) because the legislation has been carefully drafted to allow New Jersey residents with debilitating medical conditions access to marijuana to ease their suffering without creating an undue risk of abuse or diversion.
- Medical Evidence. Available medical evidence supports the use of marijuana to treat each of the debilitating medical conditions set forth in the Act: AIDS/HIV; cachexia (wasting syndrome); cancer; glaucoma; severe and persistent muscle spasms; severe nausea; severe or chronic pain; and seizures.
- Need for Access to Marijuana Despite Availability of Cesamet and Marinol Pills. While smoking carries with it certain health risks, smoked marijuana has meaningful advantages over the Cesamet and Marinol pills, which contain synthetic compounds that mimic marijuana’s primary active ingredient. Smoked marijuana is faster-acting, allows for more reliable dosing, and has fewer psychoactive side effects than the pills. In addition, smoked marijuana can be the only option for patients who can not swallow pills due to severe nausea and vomiting as a result, for example, of treatment for cancer.
- Abuse and Diversion. No state that has passed a medical marijuana law has subsequently experienced an increase in recreational marijuana use among its children and youth. The Act’s multiple safeguards against abuse and diversion of medical marijuana provide further reassurance. If passed, the Act would be among the most restrictive of all the states’ medical marijuana laws.
Below please find a brief position paper setting forth the medical evidence and policy arguments in support of the Act.
Seton Hall University School of Law
Center for Health & Pharmaceutical Law & Policy
Position Paper In Support of the “New Jersey Compassionate Use Medical Marijuana Act”
Medical Evidence
Medical evidence supports the use of marijuana to relieve symptoms or ameliorate the side effects of primary treatments of each of the debilitating medical conditions set forth in the Act: AIDS/HIV; cachexia (wasting syndrome); cancer; glaucoma; severe and persistent muscle spasms; severe nausea; severe or chronic pain; and seizures. While conventional treatments are available for some of these conditions for some patients, smoked marijuana has the potential to help those individuals who do not benefit from, or can not tolerate, currently available therapies.[1]
AIDS/HIV and Cachexia (Wasting Syndrome)
Marijuana is an effective treatment for cachexia, also known as wasting syndrome, an involuntary loss of appetite and weight linked to disease progression and death in patients with AIDS/HIV. The American College of Physicians has concluded that abundant support exists for the use of the cannabinoid delta-9-tetrahydrocannabinol (”THC”), one of the primary active ingredients in marijuana, as an appetite stimulant.[2] The FDA concurs, as evidenced by its approval of Marinol, a pill containing a synthetic version of THC, to treat “anorexia associated with weight loss in patients with AIDS.”[3]
Marijuana is also an effective treatment for AIDS/HIV-associated sensory neuropathy, a condition characterized by excruciating pain in the nerve endings that afflicts over a third of patients with AIDS/HIV.[4] In the past two years, three placebo-controlled, randomized, double-blind clinical trials published in the medical literature have demonstrated Read more
We are very pleased to welcome Kate Greenwood, J.D., to the blog today. Kate joined Seton Hall Law School in 2008 as a Faculty Researcher in the Center for Health & Pharmaceutical Law & Policy. She came to Seton Hall from Covington & Burling LLP after having graduated magna cum laude from Georgetown Law where she served as an Articles Editor of The Georgetown Law Journal. She received her undergraduate degree in Economics from Swarthmore College. Prior to her work at Covington & Burling, Kate worked as an Equal Justice Works Fellow and Staff Attorney at the Association of the Bar of the City of New York, and served as a law clerk to the Honorable Mary A. McLaughlin of the Eastern District of Pennsylvania, and to the Honorable Maryanne Trump Barry of the Third Circuit Court of Appeals.
Her work on the legal and regulatory barriers to evaluating existing drugs to determine their safety and efficacy when used during pregnancy and developing new drugs to treat pregnancy complications was selected for presentation at the 2009 St. Louis University Health Law Scholars Workshop
Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy has called for broad reforms in the marketing of drugs and devices. In a whitepaper, entitled, “Drug and Device Promotion: Charting a Course for Policy Reform,” the Center proposes legal and policy changes to address conflicts of interest in the relationship of medicine and industry. “The time is right for reform in the marketing of drugs and devices to doctors,” said Center Executive Director Tracy Miller. “Conflicts of interest have become pervasive in medical practice. Reform is needed to ensure that patients’ interests are at the heart of medical education, practice, and research,” she said.
The Center recommends: (1) making payments by drug and device companies to doctors transparent, with public disclosure by industry and physicians of their financial relationships; (2) adopting federal legislation to ban gifts, meals and other benefits provided to doctors as part of the current marketing model; (3) setting new policies to give FDA the authority to require studies of safety and efficacy of drugs and devices used off-label; and (4) undertaking a fundamental change in funding for continuing medical education to end industry support.
Moving to Transparency. The Center recommends that payments by drug and device companies to doctors should be publicly disclosed. “Transparency is critical to shore up public trust in physicians and the collaboration of industry and medicine,” said Tracy Miller. Transparency would also foster better practices by doctors and industry, advance government oversight, and provide information to the press and public. Pending federal legislation, the Physician Payments Sunshine Act, would require industry to disclose payments to doctors.
The Center supports this approach. It also recommends that states undertake disclosure by doctors, and decide how information about physician financial relationships with industry could best be shared with patients. Law Professor Kathleen Boozang adds that, “If doctors had to disclose payments from industry it would prompt them to examine their practices through the eyes of their patients and peers.”
Banning Gifts, Meals, Perks. The Center proposes adoption of federal legislation to ban the use of gifts, meals, and other perks to promote drugs and devices. The states have taken the lead to date–Massachusetts, California, Minnesota, and the District of Columbia have passed laws to limit or ban gifts and meals that are now routine in marketing practices. Concluding that industry self-regulation is not sufficient, the Center calls for national legislation to create uniform practices by industry and physicians. As urged by Professor Boozang, “the benefits of drugs and devices should drive promotion and physicians’ decision to prescribe, not a marketing model that depends on gifts and meals.”
Promoting Scientific Study of Off-Label Uses. The Center proposes that national policy should be redesigned to assure that physicians, patients and government have reliable information to make informed choices about off-label medications. Estimates suggest that as many as 40% of all prescriptions are for off-label uses. The FDA has recently issued guidelines to promote integrity and accuracy in medical articles that drug and device companies give to doctors. The Center urges that this policy guidance, while useful, does not go far enough to provide crucial information about the safety and efficacy of drugs and devices prescribed by doctors for uses other than those approved by the FDA.
The Center proposes giving FDA the authority to mandate scientific studies for off-label medications and devices that have high sales volumes or large profits but lack needed evidence of efficacy or safety. This would protect the interests of patients and advance sound choices about the risks, benefits, and economic value of off-label uses.
Reforming Funding for Continuing Medical Education (CME). Most states require physicians to undertake continuing medical education to maintain their medical license. The drug and device industry currently funds over half of the accredited CME courses available to physicians. The Center recommends that industry funding for continuing medical education should be phased out, and replaced by an educational process driven by physicians. As stated by Tracy Miller, “Physicians need to retake control of their professional education. CME should focus on doctors as professionals caring for the whole patient, not just as prescribers of drugs and devices.” While the transition to new funding occurs, the Center recommends that speakers at CME events should disclose more information about their financial interests, and physicians who are paid to promote drugs and devices should not speak at CME events about those products.
Factual Background for the Recommendations
- Ninety-four percent of physicians have some kind of financial relationship with industry, as reported in a major recent national study.
- Five states–Maine, Massachusetts, Minnesota, Vermont and West Virginia– have required industry to disclose financial relationships with physicians.
- As shown by a recent Congressional investigation of payments by industry to prominent psychiatrists, even at universities with strong disclosure policies, practices have not kept pace, leaving the public in the dark about financial ties between physicians and industry.
- Medications are widely used off-label, especially in certain fields such as psychiatry, pediatrics, and oncology. A recent study found that 73% of off-label uses lack evidence of efficacy.
- Commercial support for accredited CME, nearly all of it from drug and device manufacturers, grew from $302 million in 1998 to $1.2 billion in 2006.
Read Whitepaper here.
Tags: Ban Gifts, CME, Continuing Medical Education, Drug and Device, Drug and Device Promotion: Charting a Course for Policy Reform, FDA, Off-Label Promotion, Seton Hall Law, Seton Hall University School of Law, Think Tanks, Transparency
