Saturday, July 16, 2005
From the Daily Telegraph (London), July 15, 2005:
DAME CICELY SAUNDERS, who died yesterday aged 87, was regarded as the mother of the modern hospice movement; at St. Christopher's Hospice, Sydenham, south London, founded in 1967, she charted new approaches in techniques for treatment of the terminally ill, based on her Christian belief that no human life, no matter how wretched, should be denied dignity and love.
The full obituary is here (may require free registration). Other obituaries may be found on websites of the London Times, the Daily Scotsman, and the BBC. The LA Times syndicate has a brief note that's been picked up by a few US newspapers' websites; nothing yet from other major national papers on this side of the pond. [tm]
A new stem cell research bill has been proposed by House Republicans as an alternative to the bill passed by the House and President Bush's position. According to the N.Y. Times, this bill promotes new, unproven methods of obtaining stem cells without destroying embryos. It would set aside taxpayer money for animal studies that could eventually yield methods of developing human embryonic stem cells. Many of the ideas in the bill come from a report by President Bush's Council on Bioethics. Currently the House bill which would permit federal financing for studies on embryos left over from fertility treatments has majority support in the Senate. Senator Tom Harkin (D-Iowa) sees this new proposal as an attempt to draw Republican support away from the House bill. Senator Tom Coburn (R-Oklahoma) supports the bill as a compromise that the President would support. He says that it is a "good alternative... and it may solve the ethical constraints."
James Battey, chairman of a stem cell task force at National Institute of Health, says that right now scientists know of no way to derive human embryonic stem cells without destroying embryos. This new alternative bill proposes such concepts as carving one or two cells from microscopic eight-cell embryos to be used for research, while allowing the embryos to continue to develop.
Senate majority leader Bill Frist is expected to bring six stem cell measures to a vote in the Senate next week. He supposedly supports this new bill along with Senator Rick Santorum - although neither office will reveal the details of the bill.
Thanks to Lindley Bain for her help with this post. [tm]
Mary Anne Mitchell points to an interesting article discussing the money involved in the lucrative False Claims Act cases. The article concludes by asking where is the money going? I don't have an asnwer to that . . .
The Federal Government has built an incredible money machine in Boston! Aggressive U.S. Attorney Michael Sullivan and his equally aggressive assistants have created a uniquely lucrative legal practice in False Claims Act (FCA) cases. Their renowned Health Care Fraud Unit of the Massachusetts U.S. Attorney's office has (between May 1996 and May 2001), according to the Boston Globe, "recovered $1.54 billion for federal taxpayers, more than 30% of all health care fraud settlements by the nation's 94 U.S. attorney's offices."
That statement was printed before the Unit recovered another $1.561 billion from three more recent cases: TAP Pharmaceuticals in 2001 for $875 million; Bayer in 2003 for a combined $256.5 million, and Warner-Lambert (now Pfizer) in 2004 for $430 million. These three cases of alleged Medicare and Medicaid false claims alone make up nearly half of the $3.225 billion of Department of Justice (DOJ) health care recoveries in those three fiscal years.
This would be a good thing if these big settlements were making Medicare and Medicaid funds whole for their supposed losses and ultimately securing benefits for beneficiaries.
But are they? Let's follow the money.
Friday, July 15, 2005
Professional misconduct by researchers has sharply risen in recent years, although it has always been a problem. The journal Nature published a survey in their June 9th issue which shows that about 1.5 percent of 3,247 researchers who responded admitted to falsification or plagiarism, with one in three admitting to some sort of professional misbehavior. The AP reports that
allegations of misconduct by U.S. researchers has reached record highs. The Department of Health and Human Services received 274 complaints - 50 percent higher than 2003 and the most since 1989 when the federal government established a program to deal with scientific misconduct. The federal Office of Research Integrity has not been able to keep pace with the allegations; only 23 cases closed last year and only eight people were found guilty of research misconduct.
The article cites several recent examples of researchers being found guilty in federal courts. Eric Poehlman, a prominent nutrition researcher, will be sentenced in federal court for fabricating research data to obtain a $542,000 federal grant while working as a professor at the University of Vermont College of Medicine. He faces up to 5 years in prison. A Wake Forest University rheumatology professor made up two families and their medical conditions in grant applications to the National Institute of Health. The article features the story of Dr. Andrew Friedman who was a researcher at Brigham and Women's hospital and Harvard Medical School who faked and made up data for articles and studies he published in medical journals. He testified, "I created data. I made it up. I also made up patients that were fictitious." He formally confessed, retracted his articles, and was punished. Currently he is director of clinical research at Ortho-McNeil Pharmaceutical Inc. The article attributes one reason for cheating to the tremendous and increasing professional pressure to publish studies.
Thanks to Lindley Bain for her help with this post. [tm]
There was a good article on the business (and patient) implications when insurers (public or private) refuse to cover (usually expensive) medical devices despite the FDA's marketing approval. See Barnaby J. Feder, "When F.D.A. Says Yes, but Insurers Say No," July 6, 2005. The result of such decisions by insurers is that employees with "good health insurance" may find themselve effectively uninsured for 10's of thousands of dollars worth of device costs. [tm]
The drug company NitroMed has come up with a complex pricing system for their new federally approved heart-failure drug BiDil, specifically intended for African-Americans. The N.Y. Times reports that the price of each pill is $1.80, twice as much as some other heart-failure treatments. This would make the cost of taking pill between $5.40 and $10.80 a day, as most patients will be taking it 2 to 3 times a day. Approval of the drug came after a research study showed that it reduced mortality by 43 percent over 18 months.
The company has established a generous charity program to supplement the drug's price in an effort to make the drug more affordable to the 75,000 target patients who have no prescription drug insurance coverage. Under this program, any patient without prescription drug coverage will be able to get the pill for $25 a month; poor patients without prescription drug coverage will get it for free.
Dr. Steven Nissen, a Cleveland Clinic cardiologist who led the FDA advisory panel that approved the drug remarked that he was "[disappointed] in the decision to price BiDil beyond the financial means of many patients who might benefit." Others have said the charity program is just a way to stem criticism for setting the price so high. On the other hand, David Moskowitz, a financial analysis, compares the system to some welfare models where some people are taxed and others benefit. He says that "one can look at it as pricing where the company will be subsidizing its patient assistance program with some of the dollars from private insurers and government programs."
Thanks to Lindley Bain for her assistance with this post. [tm]
The Washington Post ran a question and answer session (online) with President Bush Sr's phsyician, Dr. Burton Lee, concerning the role of physicians in the torture of detainees abroad. You can read the question and answer session here. Dr. Lee is a member of Physician for Human Rights..
In further news, this week's New Yorker has a piece by Jane Mayer discussing in more detail the role of physicians and their participation in the torture at Guantanamo Bay. Unfortunately the article is not available on-line but you can read her question and answer session about her piece here.
Thomas L. Hafemeister, Associate Professor and Director of Legal Studies at the Institute of Law, Psychiatry and Public Policy at the University of Virginia School of Law has written a new article entitled, "Parameters and Implementation of a Right to Mental Health Treatment for Juvenile Offenders" which appears in the Virginia Journal of Social Policy and the Law, Vol. 12, No. 1, pp. 61-139 (2004). The abstract follows:
Awareness is growing of the need for mental health treatment for detained juvenile offenders. This article explores the legal issues associated with the treatment of juvenile offenders with mental health needs who are placed in secured housing. After addressing overlapping terminology that has clouded analysis of this topic, the article reviews the emerging literature on the prevalence of mental disorders among juvenile offenders and the consequences of failing to provide adequate treatment. A discussion follows of the evolution of the juvenile justice system and the guiding concepts relevant to a right to mental health treatment. The article then addresses the status of a right to mental health treatment of these juveniles, including potential bases for this right under the Constitution, federal and state statutory law, and common law. After establishing the existence of this right, its parameters and components are described. Finally, a series of issues are examined that are integral to the implementation of this right: (a) the authority of juvenile courts to order specific mental health treatment, (b) the consequences of a failure by either a juvenile offender or the agency with custody of the juvenile to comply with a court order for mental health treatment, (c) the right of a juvenile offender to refuse mental health treatment, (d) the right of a juvenile offender's parent to authorize treatment, and (e) the transfer of juvenile offenders from a juvenile correctional facility to a mental health facility. This article ultimately identifies the foundation, parameters, and implications of the right of a juvenile offender to mental health treatment.
Thursday, July 14, 2005
|Program Coordinator, Center for Health Law and Policy|
Southern Illinois University School of Law
Title: Program Coordinator, Center for Health Law and Policy
Minimum Requirements: JD or Masters Degree and at least three years of experience managing, coordinating, and promoting programs for education, healthcare, or other non-profit organizations.
Preferred Qualifications: Experience in academic/career advising is preferred.
To Apply: Send a letter of application which details your interests, qualifications and salary requirements, along with a resume and three references to:
SIU School of Law
Mail code 6804
1150 Douglas Drive
Carbondale, IL 62901
Deadline for Application: July 29, 2005
Pacific Views blog has an interesting follow-up to the Wall Street Journal's recent article concerning aesthenisates and their malpractice rates.
Kevin Drum of the Washington Monthly has some more thoughts on President Bush's tort reform plans and the potential impact such plans would have on the cost of health care. He writes,
MEDICAL CARE IN AMERICA....The United States spends about $6,000 per person on healthcare each year. Could we reduce this figure if we adopted the tort reform laws President Bush is touting? Let's roll the tape:
Malpractice awards in the United States amounted to only $16 per capita in 2001, compared with $12 in Britain and $10 in Australia, [a] team at Johns Hopkins University in Baltimore found.
From the Western New England College School of Law website, some exciting news. Big congratulations to Professor Noah.
Barbara A. Noah has been named to the faculty at the Western New England College School of Law. Dr. Anthony S. Caprio, College President, recently announced the appointment. Noah, who joins the School of Law as an Associate Professor of Law, teaches courses in Torts and in a variety of Health Law subjects.
Wednesday, July 13, 2005
The Diane Rehm show did a segment yesterday on Oregon's Death with Dignity and the legal challenges it continues to face from the Department of Justice. The guests were:
Walter Weber, senior litigation counsel for the American Center for Law and Justice
Nico van Aelstyn, litigation counsel for patient respondents in Gonzales v. Oregon
Jack Newbold, cancer patient diagnosed as terminally ill
Diane Coleman, founder of Not Dead Yet, a national disability rights organization opposing legalization of assisted suicide
It was a very informative discussion. Of course, with the possibility of as many as two new justices on the Supreme Court, the legal outcome of the lawsuit become hard to predict. [bm]
Matthew Holt, writing on Erza Klein's blog, has an interesting piece concerning the high price of health care in the United States. He reviews some new studies that reflect the higher prices we pay here for our health services. He states,
Two studies out. Neither providing exactly new news. I did a study looking at laproscopic cholecystectomy between Japan and the US for my master's thesis in 1992. The result then was that that surgery and basically all health care cost twice as much here, when in those days everything else in Japan (land, food, cars, golf club memberships, hookers) cost twice as much. Outcomes seemed to be similar even though patterns of care were very different overall.
Now a similar study (albeit done in a major journal and not for some punk's masters thesis) is showing the same thing about the costs of CABGs between the US and Canada. They cost twice as much here too. Outcomes again seem to be similar. * * * * *
Finally, in a repeat/update of an article he wrote with Uwe Reinhardt a while back called "It's the prices, stupid" Gerald Anderson shows that we spend more money here, not because of the canards of malpractice or even because we receive more services per capita, but because in general we pay more for the same thing.
The full text is an interesting read. [bm]
Tuesday, July 12, 2005
In the relatively short history of the relatively new discipline of bioethics, historical perspective can be difficult to come by. Thus, it is anybody's guess whether the recently published UNESCO's Universal Draft Declaration on Bioethics and Human Rights (24 June 2005) will prove to be the seminal document its authors intend it to be. Here's the full text (I'd be interested to know if anyone else thought it was fairly bland):
Paris, 24 June 2005
Universal Draft Declaration on Bioethics and Human Rights
The General Conference,
Conscious of the unique capacity of human beings to reflect upon their own existence and on their environment; to perceive injustice; to avoid danger; to assume responsibility; to seek cooperation and to exhibit the moral sense that gives expression to ethical principles,
Reflecting on the rapid developments in science and technology, which increasingly affect our understanding of life and life itself, resulting in a strong demand for a global response to the ethical implications of such developments,
Recognizing that ethical issues raised by the rapid advances in science and their technological applications should be examined with due respect to the dignity of the human person and universal respect for, and observance of, human rights and fundamental freedoms,
Resolving that it is necessary and timely for the international community to state universal principles that will provide a foundation for humanity’s response to the ever-increasing dilemmas and controversies that science and technology present for humankind and for the environment,
Recalling the Universal Declaration of Human Rights of 10 December 1948, the Universal Declaration on the Human Genome and Human Rights adopted by the General Conference of UNESCO on 11 November 1997 and the International Declaration on Human Genetic Data adopted by the General Conference of UNESCO on 16 October 2003,
Noting the two United Nations International Covenants on Economic, Social and Cultural Rights and on Civil and Political Rights of 16 December 1966, the United Nations International Convention on the Elimination of All Forms of Racial Discrimination of 21 December 1965, the United Nations Convention on the Elimination of All Forms of Discrimination against Women of 18 December 1979, the United Nations Convention on the Rights of the Child of 20 November 1989, the United Nations Convention on Biological Diversity of 5 June 1992, the Standard Rules on the Equalization of Opportunities for Persons with Disabilities adopted by the United Nations General Assembly in 1993, the ILO Convention 169 concerning Indigenous and Tribal Peoples in Independent Countries of 27 June 1989, the International Treaty on Plant Genetic Resources for Food and Agriculture adopted by the FAO Conference on 3 November 2001 and entered into force on 29 June 2004, the Recommendation of UNESCO on the Status of Scientific Researchers of 20 November 1974, the UNESCO Declaration on Race and Racial Prejudice of 27 November 1978, the UNESCO Declaration on the Responsibilities of the Present Generations Towards Future Generations of 12 November 1997, the UNESCO Universal Declaration on Cultural Diversity of 2 November 2001, the Trade Related Aspects of Intellectual Property Rights Agrements (TRIPS) annexed to the Marrakech Agreement establishing the World Trade Organization, which entered into force on 1 January 1995, the Doha Declaration on the TRIPS Agreement and Public Health of 14 November 2001 and other relevant international instruments adopted by the United Nations and the specialized agencies of the United Nations system, in particular the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO),
Also noting international and regional instruments in the field of bioethics, including the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine of the Council of Europe, adopted in 1997 and entered into force in 1999, together with its additional protocols, as well as national legislation and regulations in the field of bioethics and the international and regional codes of conduct and guidelines and other texts in the field of bioethics, such as the Declaration of Helsinki of the World Medical Association on Ethical Principles for Medical Research Involving Human Subjects, adopted in 1964 and amended in 1975, 1989, 1993, 1996, 2000 and 2002 and the International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences adopted in 1982 and amended in 1993 and 2002,
Recognizing that this Declaration is to be understood in a manner consistent with domestic and international law in conformity with human rights law,
Recalling the Constitution of UNESCO adopted on 16 November 1945,
Considering UNESCO’s role in identifying universal principles based on shared ethical values to guide scientific and technological development and social transformation, in order to identify emerging challenges in science and technology taking into account the responsibility of the present generation towards future generations, and that questions of bioethics, which necessarily have an international dimension, should be treated as a whole, drawing on the principles already stated in the Universal Declaration on the Human Genome and Human Rights and the International Declaration on Human Genetic Data, and taking account not only of the current scientific context but also of future developments,
Aware that human beings are an integral part of the biosphere, with an important role in protecting one another and other forms of life, in particular animals,
Recognizing that, based on the freedom of science and research, scientific and technological developments have been, and can be, of great benefit to humankind in increasing inter alia life expectancy and improving quality of life, and emphasizing that such developments should always seek to promote the welfare of individuals, families, groups or communities and humankind as a whole in the recognition of the dignity of the human person and the universal respect for, and observance of, human rights and fundamental freedoms,
Recognizing that health does not depend solely on scientific and technological research developments but also on psycho-social and cultural factors,
Also Recognizing that decisions regarding ethical issues in medicine, life sciences and associated technologies may have an impact on individuals, families, groups or communities and humankind as a whole,
Bearing in mind that cultural diversity, as a source of exchange, innovation and creativity, is necessary for humankind and, in this sense, is the common heritage of humanity, but emphasizing that it may not be invoked at the expense of human rights and fundamental freedoms,
Also bearing in mind that a person’s identity includes biological, psychological, social, cultural and spiritual dimensions,
Recognizing that unethical scientific and technological conduct has had particular impact on indigenous and local communities,
Convinced that moral sensitivity and ethical reflection should be an integral part of the process of scientific and technological developments and that bioethics should play a predominant role in the choices that need to be made concerning issues arising from such developments,
Considering the desirability of developing new approaches to social responsibility to ensure that progress in science and technology contributes to justice, equity and to the interest of humanity,
Recognizing that an important way to evaluate social realities and achieve equity is to pay attention to the position of women,
Stressing the need to reinforce international cooperation in the field of bioethics, taking into account in particular the special needs of developing countries, indigenous communities and vulnerable populations,
Considering that all human beings, without distinction, should benefit from the same high ethical standards in medicine and life science research,
Proclaims the principles that follow and adopts the present Declaration.
Article 1 – Scope
a) The Declaration addresses ethical issues related to medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions.
b) The Declaration is addressed to States. As appropriate and relevant, it also provides guidance to decisions or practices of individuals, groups, communities, institutions and corporations, public and private.
Article 2 – Aims
The aims of this Declaration are:
(i) to provide a universal framework of principles and procedures to guide States in the formulation of their legislation, policies or other instruments in the field of bioethics;
(ii) to guide the actions of individuals, groups, communities, institutions and corporations, public and private;
(iii) to promote respect for human dignity and protect human rights, by ensuring respect for the life of human beings, and fundamental freedoms, consistent with international human rights law;
(iv) to recognize the importance of freedom of scientific research and the benefits derived from scientific and technological developments, while stressing the need that such research and developments occur within the framework of ethical principles set out in this Declaration and that they respect human dignity, human rights and fundamental freedoms;
(v) to foster multidisciplinary and pluralistic dialogue about bioethical issues between all stakeholders and within society as a whole;
(vi) to promote equitable access to medical, scientific and technological developments as well as the greatest possible flow and the rapid sharing of knowledge concerning those developments and the sharing of benefits, with particular attention to the needs of developing countries;
(vii) to safeguard and promote the interests of the present and future generations; and
(viii) to underline the importance of biodiversity and its conservation as a common concern of humankind.
Within the scope of this Declaration, in decisions or practices taken or carried out by those to whom it is addressed, the following principles are to be respected.
Article 3 – Human Dignity and Human Rights
a) Human dignity, human rights and fundamental freedoms are to be fully respected.
b) The interests and welfare of the individual should have priority over the sole interest of science or society.
Article 4 – Benefit and Harm
In applying and advancing scientific knowledge, medical practice and associated techologies, direct and indirect benefits to patients, research participants and other affected individuals should be maximized and any possible harm to such individuals should be minimized.
Article 5 – Autonomy and Individual Responsibility
The autonomy of persons to make decisions, while taking responsibility for those decisions and respecting the autonomy of others, is to be respected. For persons who are not capable of exercising autonomy, special measures are to be taken to protect their rights and interests.
Article 6 –Consent
a) Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.
b) Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include the modalities for withdrawal of consent. The consent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice. Exceptions to this principle should be made only in accordance with ethical and legal standards adopted by States, consistent with the principles and provisions set out in this Declaration, in particular in Article 27, and international human rights law.
c) In appropriate cases of research carried out on a group of persons or a community, additional agreement of the legal representatives of the group or community concerned may be sought. In no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual’s informed consent.
Article 7 – Persons without the capacity to consent
In accordance with domestic law, special protection is to be given to persons who do not have the capacity to consent:
a) authorization for research and medical practice should be obtained in accordance with the best interest of the person concerned and in accordance with domestic law. However, the person concerned should be involved to the greatest extent possible in the decision-making process of consent, as well as that of withdrawing consent;
b) research should only be carried out for his or her direct health benefit, subject to the authorization and the protective conditions prescribed by law, and if there is no research alternative of comparable effectiveness with research participants able to consent. Research which does not have potential direct health benefit should only be undertaken by way of exception, with the utmost restraint, exposing the person only to a minimal risk and minimal burden and, if the research is expected to contribute to the health benefit of other persons in the same category, subject to the conditions prescribed by law and compatible with the protection of the individual's human rights. Refusal of such persons to take part in research should be respected.
Article 8 – Respect for Human Vulnerability and Personal Integrity
In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected.
Article 9 – Privacy and Confidentiality
The privacy of the persons concerned and the confidentiality of their personal information should be respected. To the greatest extent possible, such information should not be used or disclosed for purposes other than those for which it was collected or consented to, consistent with international law, in particular international human rights law.
Article 10 – Equality, Justice and Equity
The fundamental equality of all human beings in dignity and rights is to be respected so that they are treated justly and equitably.
Article 11 – Non-Discrimination and Non-Stigmatization
No individual or group should be discriminated against or stigmatized on any grounds, in violation of human dignity, human rights and fundamental freedoms.
Article 12 – Respect for Cultural Diversity and Pluralism
The importance of cultural diversity and pluralism should be given due regard. However, such considerations are not to be invoked to infringe upon human dignity, human rights and fundamental freedoms, nor upon the principles set out in this Declaration, nor to limit their scope.
Article 13 – Solidarity and Cooperation
Solidarity among human beings and international cooperation towards that end are to be encouraged.
Article 14 – Social Responsibility and Health
a) The promotion of health and social development for their people is a central purpose of governments, that all sectors of society share.
b) Taking into account that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition, progress in science and technology should advance:
(i) access to quality health care and essential medicines, including especially for the health of women and children, because health is essential to life itself and must be considered as a social and human good;
(ii) access to adequate nutrition and water;
(iii) improvement of living conditions and the environment;
(iv) elimination of the marginalization and the exclusion of persons on the basis of any grounds; and
(v) reduction of poverty and illiteracy.
Article 15 – Sharing of Benefits
a) Benefits resulting from any scientific research and its applications should be shared with society as a whole and within the international community, in particular with developing countries. In giving effect to this principle, benefits may take any of the following forms:
(i) special and sustainable assistance to, and acknowledgement of, the persons and groups that have taken part in the research;
(ii) access to quality health care;
(iii) provision of new diagnostic and therapeutic modalities or products stemming from research;
(iv) support for health services;
(v) access to scientific and technological knowledge;
(vi) capacity-building facilities for research purposes; and
(vii) other forms of benefit consistent with the principles set out in this Declaration.
b) Benefits should not constitute improper inducements to participate in research.
Article 16 - Protecting Future Generations
The impact of life sciences on future generations, including on their genetic constitution, should be given due regard.
Article 17 – Protection of the Environment, the Biosphere and Biodiversity
Due regard is to be given to the interconnection between human beings and other forms of life, to the importance of appropriate access and utilization of biological and genetic resources, to the respect for traditional knowledge and to the role of human beings in the protection of the environment, the biosphere and biodiversity.
Application of the Principles
Article 18 – Decision-Making and Addressing Bioethical Issues
a) Professionalism, honesty, integrity and transparency in decision-making should be promoted, in particular declarations of all conflicts of interest and appropriate sharing of knowledge. Every endeavour should be made to use the best available scientific knowledge and methodology in addressing and periodically reviewing bioethical issues.
b) Persons and professionals concerned and society as a whole should be engaged in dialogue on a regular basis.
c) Opportunities for informed pluralistic public debate, seeking the expression of all relevant opinions, should be promoted.
Article 19 – Ethics Committees
Independent, multidisciplinary and pluralist ethics committees should be established, promoted and supported at the appropriate level in order to:
(i) assess the relevant ethical, legal, scientific and social issues related to research projects involving human beings;
(ii) provide advice on ethical problems in clinical settings;
(iii) assess scientific and technological developments, formulate recommendations and contribute to the preparation of guidelines on issues within the scope of this Declaration; and
(iv) foster debate, education, and public awareness of, and engagement in, bioethics.
Article 20 – Risk Assessment and Management
Appropriate assessment and adequate management of risk related to medicine, life sciences and associated technologies should be promoted.
Article 21 – Transnational Practices
a) States, public and private institutions, and professionals associated with transnational activities should endeavour to ensure that any activity within the scope of this Declaration, which is undertaken, funded or otherwise pursued in whole or in part in different States, is consistent with the principles set out in this Declaration.
b) When research is undertaken or otherwise pursued in one or more States (the host State(s)) and funded by a source in another State, such research should be the object of an appropriate level of ethical review in the host State(s) and the State in which the funder is located. This review should be based on ethical and legal standards that are consistent with the principles set out in this Declaration.
c) Transnational health research should be responsive to the needs of host countries, and the importance of research to contribute to the alleviation of urgent global health problems should be recognized.
d) When negotiating a research agreement, terms for collaboration and agreement on benefits of research should be established with equal participation by those party to the negotiation.
e) States should take appropriate measures, both at the national and the international level, to combat bioterrorism, illicit traffic in organs, tissues and samples, genetic resources and genetic-related materials.
Promotion of the Declaration
Article 22 – Role of States
a) States should take all appropriate measures, whether of a legislative, administrative or other character, to give effect to the principles set out in this Declaration in accordance with international human rights law. Such measures should be supported by action in the spheres of education, training and public information.
b) States should encourage the establishment of independent, multidisciplinary and pluralist ethics committees, as set out in Article 19.
Article 23 – Bioethics Education, Training and Information
a) In order to promote the principles set out in this Declaration and to achieve a better understanding of the ethical implications of scientific and technological developments, in particular for young people, States should endeavour to foster bioethics education and training at all levels as well as to encourage information and knowledge dissemination programmes about bioethics.
b) States should encourage the participation of international and regional intergovernmental organizations and international, regional and national non-governmental organizations in this endeavour.
Article 24 – International Cooperation
a) States should foster international dissemination of scientific information and encourage the free flow and sharing of scientific and technological knowledge.
b) Within the framework of international cooperation, States should promote cultural and scientific cooperation and enter into bilateral and multilateral agreements enabling developing countries to build up their capacity to participate in generating and sharing scientific knowledge, the related know-how and the benefits thereof.
c) States should respect and promote solidarity between and among States, as well as individuals, families, groups and communities, with special regard for those rendered vulnerable by disease or disability or other personal, societal or environmental conditions and those with the most limited resources.
Article 25 – Follow-up action by UNESCO
a) UNESCO shall promote and disseminate the principles set out in this Declaration. In doing so, UNESCO should seek the help and assistance of the Intergovernmental Bioethics Committee (IGBC) and the International Bioethics Committee (IBC).
b) UNESCO shall reaffirm its commitment to dealing with bioethics and to promoting collaboration between IGBC and IBC.
Article 26 – Interrelation and Complementarity of the Principles
This Declaration is to be understood as a whole and the principles are to be understood as complementary and interrelated. Each principle is to be considered in the context of the other principles, as appropriate and relevant in the circumstances.
Article 27 –Limitations on the Application of the Principles
If the application of the principles of this Declaration are to be limited, it should be by law, including laws in the interests of public safety, for the investigation, detection and prosecution of criminal offences, for the protection of public health or for the protection of the rights and freedoms of others. Any such law needs to be consistent with international human rights law.
Article 28 – Denial of acts contrary to human rights, fundamental freedoms and human dignity
Nothing in this Declaration may be interpreted as implying for any State, group or person any claim to engage in any activity or to perform any act contrary to human rights, fundamental freedoms and human dignity.
Monday, July 11, 2005
From Modern Healthcare's Daily Dose:
Coronary artery bypass graft surgery costs about twice as much, on average, in a U.S. hospital than in a Canadian hospital, $20,673 vs. $10,373, with no difference in clinical outcomes, according to a study in [today's] Archives of Internal Medicine. Adjusting for clinical and demographic differences, the U.S. cost was 74.8% higher than the cost in Canada. The difference may largely reflect higher administrative overhead in the U.S. healthcare system, with its multiple payers, than in the single-payer Canadian system, said Mark Eisenberg, a physician at Jewish General Hospital in Montreal who helped lead the study. Defensive medicine and higher across-the-board costs in general also may be factors, Eisenberg said, adding that gauze pads cost twice as much in the U.S. as in Canada. The researchers compared outcomes and treatment costs for 4,698 bypass patients at five U.S. hospitals and 7,319 bypass patients at four Canadian hospitals.
The article is available for free only in abstract form.
On a not unrelated point, the Daily Dose ends with a link to and excerpt from yesterday's AP article by Matt Leingang, "Universal Health Care Push Being Revived." The major points:
Advocates of a single-payer system — where the government would collect taxes and cover everyone, similar to programs in Canada and across Europe — have introduced bills in at least 18 state legislatures. Some are symbolic gestures, but heated debate is taking place in California and Vermont. Even in Oregon, where voters rejected a single-payer proposal as recently as 2002, voters are organizing another ballot measure for 2008.
In Ohio, doctors, union officials and religious leaders are gathering signatures to get a single-payer health system placed on a ballot next year.In Ohio, doctors, union officials and religious leaders are gathering signatures to get a single-payer health system placed on a ballot next year.
"The level of misery with private insurers is rising, and that's why we're seeing this increased activity," said Larry Levitt, vice president of the California-based Kaiser Family Foundation, which analyzes health care issues. "But whether one state can succeed, I don't know."
Claims that the system would cost less have merit, said John Sheils, vice president of the Lewin Group, a Virginia consulting firm that conducted a study last year of how a single-payer system would work in California. The study found that the state would save $343.6 billion in health care costs over 10 years. But Sheils said a single-payer system isn't a panacea. States could be hard pressed to keep funding levels adequate during recessions, when tax revenues decline. "There are positives and negatives with all types of health systems," Sheils said. "The question that has to be asked is what are we getting out of our existing multipayer system that is worth all the money we are spending on it?"
In any event, voters are still leery. A Kaiser Foundation poll released earlier this year found that 55 percent of Americans opposed a single-payer health system. Thirty-seven percent favored it.
We haven't heard the last of this debate . . . . [tm]
Under a rather narrow set of facts, the Tennessee State Supreme Court has issued a ruling invalidating non-compete clauses between physicians and physician practices. Holding that such agreements are against public policy, the court joins several states in ruling that physician non-competes violate public policy. (I think Colorado and Massachusetts are two other states with similar rulings.)
The court also ruled against buyout clauses - essentially liquidated damages. I have to disagree with this part of the ruling. It seems that this would be a valid way for the physician practice to recoup some of its investment in recruiting, training and retention expenses even though this is a hard number to quantify. (I have seen liquidated damages clauses that included line items for office supply expenses. That's a stretch when a physician group tries to recoup its costs for paperclips.) Extreme examples notwithstanding, ruling against liquitated damages is somewhat intrusive on the freedom to contract.
Anyway - here is a link to the case. - Jim Tomaszewski, Univ Cincinnati 3L
Sunday, July 10, 2005
Melanie Warner of the N.Y. Times reports that the food and restaurant companies have effectively waged an aggressive campaign to thwart lawsuits related to obesity and related health problems. The National Restaurant Association, based in Washington, and its 50 state organizations have led the campaign with lobbyists for food companies and restaurants in each state helping to write the legislation and get the bills through the state legislatures. After several attempted lawsuits to hold food companies responsible for America's obesity problem (such as Pelman v. McDonald's), food and restaurant companies have had great success in preventing these types of lawsuits by the passage of "commonsense consumption" laws. Twenty states have enacted these kinds of laws and eleven more states have legislation pending. Although each of these laws is drafted with slight variations by lobbyists and congresspersons within the state, they basically prevent lawsuits seeking personal injury damages related to obesity from ever being tried in a court. Besides these commonsense consumption laws, the class action bill signed by President Bush will most likely make it more difficult for lawyers in obesity cases to win large awards as seen in tobacco cases. The Class Action Fairness Act (Pub. L. No. 109-2) will force class-action lawsuits with plaintiffs living in a state different from the defendant or those seeking more than $5 million in damages into federal court where large awards are less common than in state courts.
Many executives and restaurant owners personally lobbied state members of Congress by making in-person visits, testifying at hearings, and directing campaign contributions to specific lawmakers. The N.Y. Times reports that executives from Kraft and Coca-Cola personally showed up in Texas to lobby for the commonsense consumption bill, which was signed into law last month. The Institute on Money in State Politics, a nonpartisan research group, reports that the food and restaurant industry gave a total of $5.5 million to politicians in the 20 states that have these laws shielding companies from obesity liability. Michael Jacobson, executive director of the Center for Science in the Public Interest, calls this highly organized and effective lobbying effort "shameful" for trying to get special exemptions from lawsuits. He remarks that "if someone is saying that a 64-ounce soda at 7-Eleven contributed to obesity, that person should have his day in court... If it is frivolous, the courts are accustomed to throwing those out." On the contrary, Tom Foulkes, director of state relations at the National Restaurant Association, says that 89 percent of the American people say they do not support obesity lawsuits against fast-food companies. Peter Meersman, president and chief executive of the Colorado Restaurant Association says that "We wanted to makes sure that frivolous lawsuits like this never [make] it to the discovery stage, which is where these things get expensive for businesses." Even though public opinion is not currently in favor of obesity litigation, Professor Banzhaf of GWU Law School says that the situation for tobacco was similar 15 years ago when people began suing cigarette companies for making smokers sick. He says that "people changed their minds when documents started to come out about how tobacco companies misled customers about the alleged health benefits of light and low-tar cigarettes... Similarly, people will start to realize that Ronald McDonald is not their friend."
Many others are also concerned over this type of overt and powerful corporate lobbying. Larry Noble, executive director of the Center for Responsive Politics says that "It's unnerving to think that public laws are being crafted by corporate interests that simply hand language over to a lawmaker to insert in a bill." Mr. Meersman drafted the Colorado language with the input and approval of such restaurants as Arby's, Fatty's Pizza, Outback Steakhouse, and Texas Roadhouse.
Currently, the National Restaurant Association is working on the national "cheeseburger bill" with Representative Ric Keller (R-Florida) and Senator Mitch McConnel (R-Kentucky). This bill, would prevent obesity lawsuits from going forward in either federal or state courts. It is currently stalled in the House.
Richard Daynard, a Northeastern University School of Law professor and founder of the anti-tobacco movements says that trial lawyers will not be deterred. "Rather than seeking personal injury damages for the consequences of obesity, there will be lawsuits based on state consumer protection laws... There's a lot of deception in the marketplace and a lot of it is relevant to the obesity epidemic. But here we don't have to prove anyone got fat." Posted by Lindley Bain, SMU 3rd-year student.