Fourth Annual Student Health Law Conference To Be Held at Seton Hall Law on October 22nd
Filed under: Health Care Employment, Health Law, Seton Hall Law
The American Society of Law, Medicine & Ethics (ASLME) and Seton Hall University School of Law will co-sponsor the Fourth Annual Student Health Law Conference: Taking the Health Law Career Path on Friday, October 22, 2010, in Newark, New Jersey.
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.
Interested in learning more about career paths for attorneys in health and life sciences? Click here for information on attending the conference.
Center for Health & Pharmaceutical Law & Policy Submits Comments on Conflicts of Interest in Research to the National Institutes of Health
Filed under: Conflicts of Interest, Health Reform
On August 19, 2010, on behalf of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, Seton Hall Law Professors Kathleen Boozang and Carl Coleman, along with Research Fellow Kate Greenwood, submitted comments on the National Institutes of Health’s proposed revisions to its regulations governing conflicts of interest in federally-funded research. While the Center’s November 2009 White Paper Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight endorsed limits on conflicts of interest beyond those that the NIH has proposed, the revised regulations are a step in the right direction and in its comments the Center commends the NIH for its decisive action on this issue.
Briefly, the Center:
- Supports the NIH’s proposal that that researchers disclose to their institutions any significant financial interest that “reasonably appears to be related to the Investigator’s institutional responsibilities,” with “institutional responsibilities” defined to include “activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.” This comports with the Center’s recommendation in the White Paper that investigators not be charged with determining for themselves whether one or more of their financial interests could be affected by a specific research project.
- Supports the NIH’s decision to significantly lower the monetary threshold at which a researcher’s financial interest becomes “significant” to $5,000, but argues that a lower threshold would be better. Collection of data about all of a researcher’s relationships with industry, even those that fall below the proposed $5,000 threshold, would facilitate better conflict of interest assessment and management and make possible research into the effects of conflicts on research integrity and human subject welfare.
- Supports the NIH’s decision not to exclude income from non-profit entities for lectures and similar engagements from the definition of significant financial interest and its conclusion that any equity interest in a non-publicly traded entity is significant, as are any and all intellectual property rights, but encourages the agency to revisit its decision to shield from disclosure (1) equity interests held by investigators in commercial or for-profit institutions and (2) royalties and other remuneration other than salary paid to an investigator by an institution that appoints or employs him or her.
- Notes that the draft revised regulations do not address the White Paper’s criticisms that the conflict of interest regulations place no “substantive limits on the kinds of conflicts that may exist” and fail to put forth “a required minimum response for conflicts that pose the greatest risks to participants and the integrity of the research” and encourages the NIH to consider again the benefits of setting forth required minimum responses to those conflicts that are the most problematic.
- Supports the NIH’s decision to require that grantees provide “sufficient information to enable the [agency] to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Institution’s management plan.”
- Supports the requirement in the draft revised regulations that any significant financial interest that (1) is still held by a principal investigator or senior/key person, (2) is related to PHS-funded research, and (3) is a financial conflict of interest must be disclosed to the public via the world wide web.
- Supports the draft revised regulations’ requirement that investigators complete training on “the Institution’s policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of these regulations” before the commencement of research and then at least once every two years. As recommended in the Center’s White Paper, it would be beneficial for the training to include as well a discussion of the nature of conflicts of interest and their potential for harm.
- Recommends that the agency adopt its own suggestion that institutions be required to “maintain up-to-date, written, enforced policies” on institutional conflicts of interest, as they are for investigator conflicts, and that these policies be made publicly available via the world wide web. The nudge this requirement would provide is necessary because institutions have been slow to develop and adopt policies on institutional conflicts.
- Recommends that the section of the regulations devoted to remedies be revised to include a non-exclusive list of potential enforcement actions such as temporary withholding of cash payments pending correction of the deficiency, suspension or termination of the contract or grant in whole or in part, monetary assessments and penalties, and suspension or debarment from eligibility for future contracts or grants.
The Center’s comments in their entirety are available here.
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.
Seton Hall University School of Law Launches European Healthcare Compliance Certification Programme in Paris
Filed under: Compliance, Health Law, Seton Hall Law
Press Release: Seton Hall University School of Law Launches European Healthcare Compliance Certification Programme in Paris
Co-presented by:
Seton Hall School of Law and Sciences Po
June 21 - 25, 2010- Sciences Po, Paris, France
- www.sciences-po.fr/spf/healthcare
PRESS RELEASE
Phone: 973.642-8863
E-mail: simone.handler-hutchinson@shu.edu
Website: law.shu.edu/Paris OR www.sciences-po.fr/spf/healthcare
The Healthcare Compliance Certification Programme, co-organized by Sciences Po Executive Education (Paris, France) and Seton Hall University School of Law (Newark, N.J) to be held from June 21-25, 2010 on the Paris campus of Sciences Po today announced its 2010 topics and faculty.
FEATURED FACULTY:
CURRENT & FORMER REGULATORY & ENFORCEMENT OFFICIALS:
Paul McNulty, Partner, Baker & McKenzie, LLP (DC) Former U.S. Deputy Attorney General
Kirk Ogrosky, Partner, Arnold & Porter LLP (DC), Former Deputy Chief, Health Care Fraud, Criminal Division, U.S. Dept. of Justice
INTERNATIONAL ORGANIZATIONS
Alex Conte, Senior Legal Analyst, Anti-Corruption Division, OECD
Dr. Guitelle Baghdadi-Sabeti, Team Leader, Good Governance for Medicines, World Health Organization
Marie-Claire Pickaert, Deputy Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)
COMPANY COMPLIANCE PROFESSIONALS:
Dirk Brinckman, Assistant General Counsel, Johnson & Johnson (Brussels)
Roeland Van Aelst, Vice President, EMEA & Canada, Office of Health Care Compliance & Privacy, Johnson & Johnson
KEYNOTE & ACADEMIC SPEAKERS:
Paul Benkimoun, Healthcare Journalist, Le Monde
Claude Le Pen, Professor, Université Paris-Dauphine
Kathleen Boozang, Professor of Law, Seton Hall Law School (Newark, NJ)
LEADING LEGAL AND COMPLIANCE COUNSEL AND ADVISORS:
Peter W.L. Bogaert, Managing Partner, Covington & Burling (Brussels)
John Rupp, Partner, Covington & Burling LLP (London)
Karolos Seeger, Partner, Debevoise & Plimpton LLP (London)
Susie Smith, Bevan Brittan LLP (UK)
Ted Acosta, Leader, Life Sciences & Corporate Compliance Fraud Investigation & Dispute Services, Ernst & Young LLP
Jill Deal, Partner, Venable LLP (DC)
Kristof Van Quathem, Data Protection Advisor, Covington & Burling LLP (Brussels)
Carolyn Lindsey, Director of Member Services, TRACE International
Owen Bevan, Director, Legal & Compliance Practice, Corporate Executive Board
PROGRAMME CURRICULUM:
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Former UN Special Rapporteur Paul Hunt on International Law & Health as a Human Right & the Human Rights Responsibilities of Pharmaceutical Companies
Professor Paul Hunt. Photo by Sean Sime Photography
During his week-long visit to Seton Hall Law School, Paul Hunt, Professor of Law, University of Essex School of Law, provided several lectures to students and faculty on international human rights law and health law. These guest lectures included “Health as a Human Right” in Professor Elizabeth Defeis’ International Law class; “On Human Rights Guidelines for Pharmaceutical Companies” in Professor Kathleen Boozang’s Pharmaceutical and Medical Device Marketing and Compliance Class; a faculty colloquium on “GlaxoSmithKline and the Human Right to Healthcare;” and participation in classroom discussion of human rights issues raised by hospitals’ repatriation of indigent aliens in Professor Lori Nessel’s Immigration & Human Rights Clinic.
In his public presentation, “The Human Rights Responsibilities of Pharmaceutical Companies,” Professor Hunt argued that pharmaceutical companies have certain social/human rights responsibilities, including the duty to take reasonable steps to enhance equitable access to medicines. You can find an audio recording of this presentation below as well as copies of Professor Hunt’s Reports to the UN General Assembly regarding “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” and “the responsibilities of pharmaceutical companies, including innovator, generic and biotechnology companies, with regard to the right to health in relation to access to medicines.”
Professor Hunt practiced as a litigation solicitor in London before specializing in international and domestic human rights law. He has undertaken human rights work in Europe, the Middle East, Africa and the South Pacific. From 2002-2008, he served as a UN Special Rapporteur on the right to the highest attainable standard of health, and in 2008, was awarded Honorary Doctorate by the Nordic School of Public Health. He is a member of the Human Rights Centre at Essex University and Adjunct Professor at Waikato University, New Zealand.
Professor Hunt’s lecture can be streamed to your browser by clicking on the link below. Clicking on this link will also provide you with a link to download the mp3. Click here to listen to Paul Hunt’s Lecture
The two UN reports mentioned by Mr. Hunt can be accessed by clicking on the thumbnails or captions below:
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| UN Report on Right to Health | UN Report on GlaxoSmithKline |
Recording of Sam Maizel’s Discussion of Distressed Hospitals
A noted expert in the restructuring of health care business debts, both in and out of court, Sam Maizel treated Seton Hall to a one hour crash course on the fiscal crisis encountered by many of America’s hospitals. The significant financial hurdles that the hospital industry is facing has made the bankruptcy process that many hospitals encounter one of the fastest growing fields in health law.
Mr. Maizel has represented the federal government as a trial attorney in the U.S. Department of Justice’s Commercial Litigation Branch. He also served in the JAG Corps in Operation Desert Shield and Desert Storm after serving in the 101st Airborne Division and the 3rd US Infantry Regiment. Mr. Maizel now practices in Los Angeles for Pachulski Stang Ziehl & Jones LLP.
You can download Mr. Maizel’s talk here, or alternatively, you can stream it to your browser by clicking “Play” below:
Online Graduate Certificate Program in Health & Hospital Law to Launch in April 2010
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is set to launch a new online program in Health & Hospital Law. The new Graduate Certificate in Health & Hospital Law is a non-degree program designed for individuals who seek in-depth knowledge about legal, regulatory, and ethical issues related to health care delivery. Taught exclusively online, it offers students nationwide a targeted immersion in key substantive issues along with the practical skills necessary to research and communicate effectively about the law.
The intensive program is geared to busy professionals who want to cover a significant amount of material in a relatively short period of time. The program is open to students who have earned a baccalaureate degree from an accredited college or university. It is specifically designed to meet the needs of mid- to senior-level professionals in the health care industry, but highly motivated students from other backgrounds are also welcome to apply. It is not necessary to have prior academic or work experience in health care in order to do well in the program.
The first class begins April 18, 2010 and applications are being accepted now. Additional information is available at: law.shu.edu/onlinecertificate
Financial Remuneration of Clinical Study Investigators
Filed under: Conflicts of Interest, Drugs & Medical Devices, Physician Compensation, Research
In November 2009, the Center for Health & Pharmaceutical Law & Policy, in its White Paper, Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight, explored payments to investigators — and other potential motivators — to conduct research. A study in this month’s IRB: Ethics & Human Research explores the impact payments may have on researchers to conduct and complete studies. In Motivated by Money? The Impact of Financial Incentive for the Research Team on Study Recruitment, Sharon Unger and her colleagues examine the effect financial remuneration has on researchers in a neonatal intensive care unit (NICU).
Taking advantage of a “fortuitous set of circumstances” in which two separate clinical trials with nearly identical inclusion criteria were conducted simultaneously in an NICU in Canada, the authors looked at two issues: 1) whether financial remuneration impacted the rate at which the research team approached parents about research participation, and 2) whether financial remuneration impacted the rate at which parents provided consent to participate.
In the first study (Study A), a placebo-controlled trial involving a medication that was the standard of care for treatment of newborns nearing extubation to prevent apnea of prematurity, members of the research team were financially compensated for their time if they were successful in obtaining parental consent (parents were unaware of this arrangement). In the second study (Study B), which involved two different forms of noninvasive respiratory support following extubation, there was no financial compensation of the research team. Both studies had the same recruiting team. Study A was federally funded, multicentered and high-profile, while Study B was a single-center, unfunded trial.
The payments in Study A were per capita, which, while creating a direct incentive to recruit individual enrollees, is usually not problematic as long as the payment is not excessive. The Center recommends “that the benchmark for compensation for physician services for research should be comparable payment for time and services for treatment. This will compensate physicians fairly for their time and services, and will assure that there are no hidden bonuses or incentives for physicians to recruit patients into research or to refer them to research rather than treatment.” As noted in the study, finder’s fees are increasingly considered “ethically problematic;” the Center recommends a wholesale bar on finder’s fees because they can create conflicts of interest that can incentivize investigators to recruit and retain individuals who do not meet the study’s inclusion and exclusion criteria.
As the authors noted, and as acknowledged in the Center’s White Paper, potential enrollees are increasingly vulnerable as increasing numbers of individuals seek to participate in research either as a primary means of access to treatment or as a form of income. The results of this study indicate a much higher likelihood of approach when there was a prospect of financial remuneration. These results are concerning, and were anticipated by the Center’s White Paper, which noted the potential for poor compliance with inclusion and exclusion criteria and pressure to enter or remain in a clinical trial.
However, surprisingly, the authors found that, despite the much higher likelihood of approach for Study A than Study B, parents were much more likely to actually agree to enroll their newborn in Study B — for which there was no financial remuneration of the research team. The authors explored various explanations for this result, including that the research team was overly cautious about giving the appearance that their approach for consent was motivated by financial compensation, or that parents chose to withhold consent due to the research team’s increased pressure.
The authors do acknowledge other potential factors — beyond financial remuneration – that could have affected the study’s results. For example, parents’ hesitancy to enroll their newborn in a placebo-controlled drug trial could explain the discrepancy between enrollment in the studies. Likewise, the authors consider that parents may not have been able to differentiate between the two modes of support being investigated in Study B. In addition, the recruiting team, when presented with the results of the study, did not recall feeling influenced by the financial arrangement of Study A, but did “recall being highly motivated to ensure the success of Study A as it was part of a high-profile, multicentered trial.”
The authors concluded by noting concerns that “there may be a point at which the amount of the financial remuneration or the manner in which it is assigned could negatively impact the ethical conduct of the researcher,” but cautions that these concerns should be balanced with the value of conducting research in patients’ best interests. This balancing act is considerably important. As the Center notes,
Research is critical to the advancement of medical treatment and health. It must be structured to produce high quality data that facilitates the assessment of safety and efficacy in the population for whom the treatment will be used. The good of the enterprise requires that the clinical trial system sufficiently balance the costs and benefits to physicians and prospecÂtive trial participants to ensure the continued sufficient supply of researchers and subjects. The system must also be imbued with actual and perceived integrity — so that it produces scientifiÂcally reliable results, participants are safe, and people trust the system sufficiently to be willing to participate.
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy Issues White Paper Calling for Major Reforms in the Financing and Oversight of Clinical Research
Filed under: Conflicts of Interest, Research, Transparency
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.
Position Paper In Support of the “New Jersey Compassionate Use Medical Marijuana Act”
Filed under: Prescription Drugs, Proposed Legislation, State Initiatives
[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
Introducing Tracy E. Miller, Executive Director of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy
Today we are very pleased to welcome Tracy E. Miller, J.D., to Health Reform Watch. Ms. Miller is the Executive Director of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy. She received her J.D. from Harvard Law School, cum laude, and her undergraduate degree from Brown University, magna cum laude. From 2001-2007, Ms. Miller served as General Counsel and Senior Vice President of the Catholic Health Care System (CHCS), a health care system comprised of hospitals and nursing homes in New York City and the Hudson Valley. While at CHCS, Ms. Miller oversaw legal and compliance services for the Health System and its ten member facilities. Prior to joining CHCS, Ms. Miller was Vice President for Quality and Regulatory Affairs at the Greater New York Hospital Association.
From 1996-2000, Ms. Miller was Associate Professor in the Department of Health Policy at the Mount Sinai School of Medicine, where her scholarship and publications focused on a range of topics, including medicine online, financial disclosure, and trust in the patient-physician relationship, and managed care regulation. During that time, Ms. Miller also served as Project Director of the National Quality Forum Planning Committee, a group of national leaders in health care delivery and quality convened by Vice President Gore. The committee was charged with building a new national organization to set standards for quality measurement and improvement across the health care industry. Prior to joining Mount Sinai, Ms. Miller was the founding Executive Director of the Governor’s Task Force on Life and the Law, a commission of experts and leaders drawn from healthcare, legal, civic, and religious organizations to craft policy for New York State. In that capacity, she developed law and policy on issues raised by medical advances, including New York’s health care proxy law, the do-not-resuscitate law, and the law on the procurement and distribution of organs for transplantation.
Ms. Miller is the Past Chairperson of the 1100-member Health Law Section of the New York State Bar Association and a Member of the Health Law Section Executive Committee from 1995-2001. She has written and spoken extensively to national and state organizations on healthcare policy, law and ethics. She joined Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy as Executive Director in 2008.
Dr. Kuklo and the Larger Lesson: Transparency in Medical Research
Flammarion Woodcut. First documented to 1888
[Ed. note: We are very pleased to welcome Valerie Gutmann, J.D. to the blog today. Valerie joined Seton Hall Law School in 2009 as a Faculty Researcher in the Center for Health & Pharmaceutical Law & Policy. She came to Seton Hall from Kirkland & Ellis LLP after having graduated from Harvard Law School, where she served as an author and Editor-in-Chief of the Recent Developments Section of the Journal on Law, Medicine, and Ethics. Prior to law school, Valerie worked at the National Academy of Sciences, the American Association for the Advancement of Science, and the ABA Coordinating Group on Bioethics & the Law. In 2001 she graduated from the Woodrow Wilson School of International Affairs and Public Policy at Princeton University, magna cum laude, where she was co-president of the Princeton Bioethics Forum.]
In a glaring example of the consequences of less-than full disclosure in research and publication, recent reports have shed light on Dr. Timothy R. Kuklo’s study of Infuse. Dr. Kuklo’s article on the bone-growth protein manufactured by Medtronic Inc. was published by the British Journal of Bone & Joint Surgery in August 2008, and was retracted in March 2009, after an army investigation found that Dr. Kuklo’s study had misleadingly promoted Infuse as “strikingly” better and more efficacious than conventional bone grafts in repairing severely shattered shin bones of Americans injured in Iraq.  Kuklo has been accused of using “falsified information” that did not match with patient records and forging signatures of four doctors at Walter Reed Army Medical Center who he falsely claimed to be co-authors. Dr. Kuklo also neglected to disclose his relationship with the company.
Dr. Kuklo, a former army surgeon at Walter Reed, is currently on leave from Washington University School of Medicine in St. Louis, where he was associate professor of orthopaedic surgery, specializing in cervical spine, spinal deformity, spinal tumors, and spine trauma. From August 2006 through May 2009, Dr. Kuklo was a consultant to Medtronic, who recently announced that Dr. Kuklo’s consultancy contract was being suspended (some accounts controvert the alleged timeline, and Medtronic claims that it had no involvement in the study and did not depend on the study for government regulatory approval). While working for the army, Dr. Kuklo was also paid by Medtronic to speak on the company’s behalf at meetings and to train other doctors, and was a recipient of thousands of dollars worth of trips. Military officials have stated that there are no records that Dr. Kuklo had sought or received permission to accept money to consult for medical product companies.
Last year, Senator Chuck Grassley (R, Iowa) called for an investigation into Dr. Kuklo’s study. Senator Grassley requested information from Walter Reed, Washington University, Medtronic, and two medical journals. He has also publically released a list provided by Medtronic of consultants for the Infuse product, on which Dr. Kuklo had suspiciously not been included. Spokespeople for Medtronic noted that Dr. Kuklo was not on the list because he was a general consultant to the company, rather than specific to Infuse, although he has spoken on behalf of Infuse in the past.
The Kuklo case is further evidence of the implications of incomplete disclosure, which may lead physicians to make medical decisions without all the information that should be available to them. As we have noted in the past, the Center for Health and Pharmaceutical Law & Policy has vigorously called for such reform in its 2009 whitepaper:
All those engaged in medical research and publication, including medical professionals and institutions, medical journals, and industry, should undertake reforms to ensure the integrity of the medical literature. Transparency in the relationship of industry and physicians would be a critical tool in this effort.
Posts from Health Reform Watch have been cited by media sources throughout the country, including Kaiser Health News, The Health Care Blog, NPR's Planet Money Blog, Duke Univ. Med. Center News, American Health Line Alerts, BusinessWeek.com, Concurring Opinions, Balkinization, The New England Journal of Medicine, Harvard's Nieman Foundation for Journalism, The New York Times, Washington Post, L.A. Times, Las Vegas Sun, Maggie Mahar, Ezra Klein, Tom Geoghegan, and the official homepage of the Office of the Democratic Majority Leader of the House of Representatives, Steny Hoyer.
