Viewing by month: May 2011
May 31, 2011 | Posted By Posted By David Lemberg, M.S., D.C.

Genes are patented. Not Lee's or Levi's — not those jeans. Sequences composed of adenine, thymine, guanine, and cytosine — those genes. How absurd. How cunningly reductionistic. How indirectly nihilistic. Camus, Beckett, Ionesco, and Vonnegut are laughing up their ghostly sleeves. 

Only in America. Well not quite only here. But close. The sad part is that patenting gene sequences is not the worst demonstration of capitalism behaving badly. But it is still very bad behavior indeed.

An ACLU lawsuit is challenging the legality of such gene patents.1 On March 29, 2010 a New York federal court ruled that the patents on two specific genes, BRCA1 and BRCA2, are invalid. Myriad Genetics, the company that "owns" BRCA1 and BRCA2 and holds patents for breast cancer gene analysis, appealed the ruling. The U.S. Court of Appeals for the Federal Circuit heard Myriad's appeal in April 2011.

The ACLU has it right. Any patenting of organisms or an organism's parts restricts the advancement of science. In the case of medical science the unfortunate consequences can be deadly. One of the key workers on The Human Genome Project makes the ridiculous statement that "The goal of patenting a gene is not to make anyone rich, but to force disclosure of secret information." I don't think so. The goal of patenting is exclusively relates to the hope of becoming rich.

This is an ethical issue. Patenting pieces of a human being directly violates the bioethical principle of respect for persons. Patenting part of the human organism directly treats humans as means to an end — that end being the ever-increasing bank account of biotechnology (there's a misnomer!) venture capitalists and executives.

It has been naively suggested that the provisions of the Bayh-Dole Act could intervene when biomedical research is impeded. It is the Bayh-Dole Act itself that spurred the explosion of patent-seeking activity on the part of universities. Bayh-Dole led directly to the notorious epidemic of conflicts-of-interest between universities and the corporations they were so happy to jump in bed with.

A professor of law at Columbia University has stated "When you isolate something as it appears in its natural state you change it, even if the only change is the isolation." This statement is disingenuous, as gene patents apply directly to the in situ DNA sequences themselves.

Companies such as Myriad Genetics hold the entire world hostage. Responsibility for the consequences must be shared by the U.S. Patent and Trademark Office. The USPTO played with fire and patients are left scrambling for their literal lives while their metaphorical houses burn to the ground.

A company receives a patent for a gene sequence. Fees are now due that company, paid by all other companies that wish to design a diagnostic test related to that sequence, manufacture proteins coded by that sequence, or generate proteins produced by another gene which is regulated by the patented gene. From my perspective, such patents violate the common law doctrine of restraint of trade. They impede the freedom of others to conduct business.

This is the root of the problem, of course. Medicine is no longer a profession. Medicine is a business. That transformation is the source of all the trouble relating to patents concerning medical practice.

1ACLU Challenges Patents On Breast Cancer Genes

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

May 25, 2011 | Posted By Ricki Lewis, PhD

Think it’s a great idea to send off a spit sample to see which future health conditions lurk in your DNA? In the U.S., the Genetic Information Nondiscrimination Act (GINA) prevents employers from using that information to weasel out of blame for workplace injuries, but in Canada, according to a just-released study, DNA information may come back to haunt you.

Canadian researchers Jeff Nisker, Roxanne Mykitiuk and colleagues report 490 genetic predispositions cited in 468 legal cases, from 1984 to 2010. Most of the cases dealt with worker’s compensation claims, in which an employer could point to an inherited predisposition to arthritis as causing joint pain, rather than to, say, an anvil falling on a foot. Although no overt cases of genetic discrimination emerged, the authors urge “future monitoring.” 

They also question whether lawyers can read between the lines of the genetic testing websites. Consider osteoarthritis. I went to 23andMe to see exactly what they’re hunting for when consumers send in DNA. The company uses two “preliminary research reports,” one for a common gene variant in Asians, the other a genome-wide association study (GWAS) test result among European women. Gene #1 raises risk 0.7 fold; the association, 1.5 fold. If a black man or Hispanic woman in Ontario seeks compensation for a hurt thumb, and has taken said 23andme test, might the employer argue that the pain was genetically predestined? Would the attorney know the difference between a variant of a single gene, a GWAS result, or the context of the result in terms of population genetics or other genetic risk factors for osteoarthritis that 23andme does not test for?

May 19, 2011 | Posted By Posted By David Lemberg, M.S., D.C.

Preliminary results from a large clinical trial demonstrate that persons with HIV are "96% less likely to pass on the infection" if they are taking antiretroviral medications.1 Based on the substantial protection afforded by early treatment, an independent safety review panel "recommended that the drug regimens be offered to all participants". The randomized clinical trial, known as HPTN 052, was scheduled to run until 2015, but is being ended early. Formulating public policy on the basis of these compelling findings would seem to be a slam dunk. But there are various stumbling blocks, both ethical and fiscal.

Physicians treating patients infected with HIV may face an ethical quandary. Initiating antiretroviral treatment as soon as a person becomes infected would substantially lower the risk of that person infecting others. But some patients are concerned about the potential side effects of AIDS drugs. Such persons avoid taking medication until they become obviously ill or until their CD4 count falls below 350 cells per cubic millimeter of blood (an accepted indicator of severity of infection).

Such a waiting game may satisfy the needs and desires of the infected person, but places the life of his sexual partner(s) at grave risk. Thus, the request to delay treatment poses an ethical dilemma for the doctor in the case. From the perspective of autonomy, it appears that the patient is exercising his right to make his own choice. But such a choice ongoingly threatens the lives of others.

If the doctor acquiesces, believing he is supporting the patient's right to an independent choice, he is necessarily violating the bioethical principle of nonmaleficence, i.e., do no harm. Beyond the direct, life-threatening harm that will be done to the HIV-infected person's sexual partners, serious burdens are placed on society in the form of increased utilization of costly services. Medical services, institutional facilities, health care workers, supplies, and medications, as well as social services and possibly hospice services, will all need to be funded and paid for by an ever-diminishing supply of available tax dollars. The physician who supports his patient's refusal to begin an early regime of antiretroviral medication fails to prevent an ongoing substantial drain of resources that could have been used elsewhere.

The response by concerned journalists to the breaking news was immediate. In an Op-Ed in The New York Times the following day,2 Charles Blow emphasized that federal and state governments have been "starving or restricting support, services and prevention efforts" for HIV-infected persons and those at risk of contracting HIV. He noted the vulnerability of those most dependent on AIDS Drug Assistance Programs (ADAP). Three-quarters of those enrolled in ADAPs have incomes less than 200% of the national poverty level. Fifty-five percent of those enrolled are black or Hispanic.

Blow doesn't hesitate or hold back his challenge, stating "it is morally reprehensible to restrict or deny life-saving drugs to those who need them". Such penny-wise budget cuts are "a colossal miscalculation of public health policy". Slashing funding for social welfare programs such as AIDS Drug Assistance may help squeeze dollars out of government budgets in the short term, but limiting or denying care to chronically ill persons will impose substantial financial costs in the long term.

The convincing evidence of HPTN 052 in supporting early treatment of HIV infection highlights another ethical issue with profound global implications. For many years HIV medications have been scarce or unavailable in the countries and regions that need them the most, including sub-Saharan Africa, South and Southeast Asia, and Central and South America. Of course, in the United States, too, many poor people without health insurance are on waiting lists to receive HIV medications.

The pharmaceutical corporations manufacturing these drugs can easily make them affordable to endemic communities. For example, GlaxoSmithKline's net profit in FY 2010 was almost $3 billion.

How much profit is enough? What if GSK's profit was capped at $1 billion annually? Does that seem draconian? One billion dollars is an unfathomable amount to the billions of persons on the planet who struggle to subsist on less than $2 per day. Surely $1 billion profit is sufficient for a corporation's executives and shareholders? The $2 billion left over (give or take) would go far toward providing HIV medication at cost to those who cannot afford such care on their own.

Such beneficence would have a meaningful impact in "winning the fight against AIDS".

1"Early H.I.V. Therapy Sharply Curbs Transmission", The New York Times, May 12, 2011

2"H.I.V. SOS", The New York Times, May 13, 2011

May 16, 2011 | Posted By Posted By David Lemberg, M.S., D.C.

A bioethicist, obviously, is a person who practices bioethics. But what does this entail? On one hand, bioethics could be narrowly construed as focusing on medical ethics. A broader perspective exists, based on an expansion of bioethics to "biological ethics". Both frameworks, the narrow and the broad, are eminently valid and neither needs to exclude the other.

The need for bioethics and bioethicists is greater now than ever. Bioethicists are able to offer substantial value to communities at all levels, ranging from the level of the individual (a community of one) to the level of the planet (a global community), conceived as an intricately interwoven biosphere.

Let's get specific. What are the kinds of things that bioethicists do?

A bioethicist could be a member of a hospital staff and function as a clinical consultant. Bioethics consultations facilitate patient care in

  • Determining capacity/competency related to making an informed choice
  • End-of-life planning and decision making
  • Determinations of medical futility
  • Assisting families in making decisions regarding withdrawal of life support

A bioethicist may also function as an ombudsman for the patient and family, helping to establish ongoing clear and effective communication among all concerned parties. Depending on the context and the need, she would consult with the patient, the patient's family, medical staff, and administrative personnel.

In such a practice, the bioethicist is applying daily the principles of autonomy, beneficence, nonmaleficence, and justice. He is engaged in rewarding, exciting, ever-changing work with real people grappling with real, life-impacting challenges. Every day presents new opportunities to help make a meaningful difference at an individual, family, and community level.

And, much more is possible. Bioethics need not be restricted to the medical arena. Looking beyond the world of hospital practice, there are an abundance of opportunities for the bioethicist to paint with a broader brush.

For example, what are the responsibilities and accountabilities of global pharmaceutical companies? Almost 3 billion people worldwide live on less than $2 per day. These persons do not have the wherewithal to afford life-saving medications. The pharmaceutical giants are very glad to conduct clinical trials in developing nations where the costs of doing business are substantially lower than in their home countries. But these companies do not reciprocate and provide drugs at cost to indigent communities and societies. Bioethicists can help create policies focusing on distributive justice to be implemented by multinational pharmaceutical corporations.

The fields of wildlife conservation, sustainability, and renewable resources could all be enhanced by bioethics-informed policy. Human health and welfare depend not only on our interactions with each other. If bioethics intends to support the thriving of humans, it necessarily intends to support the thriving of redwood forests, coral reefs, butterflies and bumblebees, songbirds, and tuna and salmon. Natural capital and ecological services are valued at many trillions of dollars annually. Each of the four iconic bioethical principles is intimately related to maintenance and support of our natural world.

Bioethicists may work in universities, hospitals, all levels of government, policy institutes, and NGOs. Importantly, bioethicists could also work in corporations. What sort of corporation—national or multinational—would hire a bioethicist? If the corporation’s sole interest is its bottom line, i.e., profit and shareholder dividends, bioethics would most likely not fit into its strategy.

But a corporation’s board could have a different vision. Such a board could understand that the organization's long-range welfare is closely tied to the global economy, which is closely tied to the welfare and productivity of all populations, which is closely tied to ensuring the ongoing viability of environmental resources and ecological services. Such a corporation’s goals would be greatly furthered and assisted by having bioethicists on staff.

Too often, an observer of the field gets the impression that bioethics is primarily concerned with parsing ever finer notions of patient autonomy. On this view, it is IRBs rather than angels which are dancing on the head of a pin. Switching metaphors, such navel-gazing helps no one, except to provide meager support for struggling academic careers.

Bioethics is not this. Bioethics is the broad end of the funnel. Almost 50 years ago in his famous book Love and Will, the American psychologist Rollo May described the transitional nature of then-modern 1960s society. Those transitional qualities have persisted rather than resolved. The global economy is in crisis. Global climate change is apparent. Environmental resources and species diversity are at great risk. Health care, as such, is unrecognizable compared to 50 years ago, and not in a good way.

Bioethics and bioethicists can provide unique perspectives and original solutions in helping resolve the diverse challenges facing not only the United States but our global society. Bioethics and bioethicists can participate fully and become critical assets in humanity's search for meaning, self-realization, and discovery of arete.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

May 10, 2011 | Posted By Danielle Holley, JD, MS

In March, Congress reintroduced a bill: the “Part D Off-Label Prescription Parity Act.” (H.R. 1055) (See info here)  Currently, Part D covers off-label drug treatments for cancer but not for those patients who suffer other chronic conditions.  These patients can seek payment for off-label use under Medicare Part B, for those off-label drugs that are supported by peer-reviewed medical literature or in a compendium.  The goal with the Part D legislation is to adopt the standard under Part B to allow for chronic conditions, including others than cancer, to have payment for off-label drugs that not only are listed in compendia but also are supported in peer-reviewed literature.  Currently, the bill is still stuck in the Subcommittee on Health.

This is important legislation to create parity across the Medicare plans but also to recognize the balance needed in allowing for off-label drug use.  It has been shown that off-label drug use varies somewhere between 21% to 50% depending upon the drug and classification (1).   It is important that this legislation recognizes that off-label drug use can be beneficent for patients, but may also have harmful effects.  I have argued elsewhere  (2) that we need to have some regulation for off-label drug use because of the potential for harmful side-effects, and the legislation proposed along with Medicare Part B regulations demonstrate that need for off-label drug use to be governed by the standard of care either as noted in a compendia or supported in peer-reviewed literature.  A case heard by the federal court in the Southern District of New York, upheld this by stating that Medicare must cover off-label drug use for treatment that is medically necessary as supported by compendia or peer-reviewed literature.  

Off-label drug use can be extremely beneficial and it is important to not the overly limit the art of medicine.  It is equally important that we not draw arbitrary lines by not allowing patients to access and be covered for these important off-label drug uses that have been supported in the literature or compendia.  The healthcare system already has enough hurdles to jump through and Congress creating more hurdles by singling out certain diseases or not being consistent in their coverage is unjust and detrimental to patients, physicians, and the physician-patient relationship.  We need to set regulations to both protect patients and physicians but also respect the physician-patient relationship by being consistent and allowing for innovative uses that have been established as effective treatment.  

(1) Danielle Holley, Comment, Balancing on the Edge: The Implications and Acceptability of Off-Label Drug Use, 19 ALBANY J. SCI & TECH 633, 633 (2009).  
(2) Id.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

May 6, 2011 | Posted By Posted By David Lemberg, M.S., D.C.
Philip Ball
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Dr. Steven Nissen is Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. Dr. Nissen has served as President of the American College of Cardiology and has authored or coauthored more than 350 articles and 60 book chapters.

In recent years Dr. Nissen has written extensively on drug safety. In 2001, he co-authored the first manuscript that raised concerns about the safety of Vioxx. In 2007, he authored a manuscript which demonstrated that the widely used diabetes drug Avandia increased the risk of myocardial infarction.

Dr. Nissen is also known for his role in public policy discussions, particularly in the area of drug safety. He has testified in both the Senate and House of Representatives on the need to reform the FDA.

In our 5-3-2011 BIOETHICS TODAY conversation, Dr. Nissen discusses

  • Conflicts of interest in developing cardiovascular clinical practice guidelines
  • Conflicts of interest involving financial relationships among physicians and hospitals on one hand and pharmaceutical companies and medical device companies on the other
  • Inappropriate use of new technologies, particularly referencing "Left Main Trunk Coronary Artery Dissection as a Consequence of Inaccurate Coronary Computed Tomographic Angiography", Dr. Nissen's recent article in the Archives of Internal Medicine [Arch Intern Med 171:698?, 2011]
  • The need for incorporating Bayesian decision making in the ordering of diagnostic testing
  • Medical and ethical issues related to Avandia

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

May 4, 2011 | Posted By Posted By David Lemberg, M.S., D.C.
Philip Ball Unnatural Book Cover
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Philip Ball is the author of the new book, Unnatural: The Heretical Idea of Making People. Unnatural is published by The Bodley Head, a division of Random House. Philip Ball is a freelance writer. He previously worked for over 20 years as an editor for the international science journal Nature. His book Critical Mass won the 2005 Aventis Prize for Science Books. Philip’s other books include Bright Earth: The Invention of Colour and The Music Instinct.

In our 5-3-2011 BIOETHICS TODAY conversation, Philip Ball discusses

  • The relevance of the idea of artificlal procreation for society today
  • In vitro fertilization, embryonic stem cell research, cloning
  • The intrusions of myth and legend in policy discussions involving research in the fields of reproductive medicine and regenerative medicine
  • Our fears and assumptions about making people using artificial means – "anthropoiesis"
  • How the term "unnatural" may be a moral judgment, involving both metaphysics and a "perpetually uneasy relationship with techne"
  • Should limits be imposed on technology?
  • Considerations of human uniqueness and the context for the emergence of new technologies

The Alden March Bioethics Institute offers graduate online masters in bioethics programs.  For more information on the AMBI master of bioethics online program, please visit the AMBI site.

May 2, 2011 | Posted By Posted By David Lemberg, M.S., D.C.

Bioethics Today — A Manifesto

The field of bioethics is in the right place at the right time. The right place is at the intersection of medical practice, health care delivery, health care policy, and development of clinical guidelines and standards of care. The right place includes bioengineering, nanotechnology, pharmaceutical R&D, and environmental conservation and sustainability. Bioethics concerns range far afield, encompassing reproductive medicine, regenerative medicine, stem cell research, and man–machine interfaces.

Bioethics investigates and explores the underpinnings, ramifications, and implications of democracy, human rights, freedom of the individual, the existence of free will, and the origins and implementations of moral and ethical systems.

The right time for bioethics is right now. The present moment. The great philosopher Arthur Schopenhauer wrote, "Future and past are only in the concept. . . . The present alone is the form of all life, but it is also life's sure possession which can never be torn from it."1

In short and in effect, bioethics focuses on being-in-the-world. That is a pretty big mandate. The practical result is that there is unlimited opportunity for innovation and development of outside-the-box solutions to real-world problems. For example, the health care system is desperate for impactful and visionary leaders. In the United States we have several dozen, possibly more. Yet the actual need is for hundreds, even thousands, of such leaders, operating in government, industry, higher education, health care delivery complexes, and non-profit policy centers.

Bioethical conundrums abound, including

  • The six-figure-plus annual costs of many cancer medicines
  • The ongoing lack of access to and availability of HIV medication in Africa and Southeast Asia.
  • Access and availability of health care services, worldwide
  • The moral status of the embryo and the ethics of embryonic stem cell research
  • End-of-life decision making
  • Prenatal genetic testing and counseling. Reproductive freedom, including IVF, same-sex parenting, and surrogacy

The world of bioethics is as big and broad, as deep and rich, as extensive and wide-ranging as the world we live in. The problems and challenges of humans (as the presumptive stewards of the planet) are the problems and challenges of bioethics. The historical four principles of bioethics—autonomy, beneficence, nonmaleficence, and justice—provide a firm foundation for this next generation of work to be done. These principles represent a launching pad for a new phase of endeavor. A phase in which bioethics can provide insight, guidance, and action steps to facilitate the thriving of all species, inclusive of our entire ecosphere.

1Schopenhauer A: The World as Will and Representation, Vol. 1, p 278. New York, Dover Publications, 1969

The Alden March Bioethics Institute offers graduate online masters in bioethics programs.  For more information on the AMBI master of bioethics online program, please visit the AMBI site.

BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.