Health Affairs

There is a growing consensus that the regulatory system for research is in need of reform. Established 21 years ago by the Common Rule, it has functioned via a rigorous environment to assure that risk in research is dealt with and transparency maintained.

The trigger for these regulations is a definition of research as a “systematic investigation…designed to develop or contribute to “generalizable knowledge.” When this definition is satisfied, an intensive set of requirements ensues including review, approval, and continued oversight by an Institutional Review Board (IRB); reporting requirements;, the necessity for informed consent (often highly complex); and other administrative components. If projects are not “generalizable,” (e.g., local hospital programmatic or quality review), they fall strictly under healthcare system purview rather than under Common Rule regulatory oversight.

The current system has a strong moral imperative and has been critical to mitigating risk for research subjects and providing transparency. However, it is burdensome and fails to take into account the considerable progress made in both the research and clinical enterprises over the last few decades: in research, technological advances in generating data on routine care, and in healthcare, much more stringent oversight.

Editor’s note: For more on the attitudes of Americans toward medical care and empowering patients to be active participants in their own care, see the February issue of Health Affairs, “New Era Of Patient Engagement.”

The attention now devoted to defining the proper role of patients and consumers in clinical decision-making is unusual, both in terms of who is addressing the issue and the intensity of the concern. Once, it was physicians and bioethicists who took the lead; now it is health policy analysts and health care administrators. Their aims go well beyond improving doctor-patient communication or promoting patient autonomy. The primary goal is to enlist patients in the effort to bring fundamental change to health care delivery.

The obligations conferred upon or assumed by patients have changed dramatically over the past half-century. Well into the 1950s, prevailing norms reflected Talcott Parsons’ formulation of the sick role. Patients were duty-bound to seek medical care when ill and follow physicians’ orders. In the 1970s and ‘80s, the new field of bioethics successfully challenged this paradigm, demanding that physicians obtain patients’ informed consent for all interventions, particularly in end-of-life decision-making.

Current expectations are different, less concerned with bioethical principles like autonomy and more committed to the idea that unless patients are genuine partners in medical decision making, altering the health care delivery system is not likely to succeed. The goal is not to advance patient rights but to transform patterns of care.

“Are human genes patentable?” On November 30, 2012, the U.S. Supreme Court agreed to answer this single question in Association for Molecular Pathology v. Myriad Genetics. Of course, the petitioners, including health care providers, professional associations, and patients, worded the question to favor the answer they want: “No, human genes are not patentable.” For Myriad Genetics, the patent owner who would like its patent rights upheld, the question is better phrased as whether one can patent “isolated molecules of deoxyribonucleic acid that were identified and defined by human inventors.”

The practical stakes in the Court’s decision, which should come in the first half of 2013, are enormous. The U.S. Patent and Trademark Office (USPTO) has issued tens of thousands of patents on genetic sequences over the past few decades, and the U.S. Court of Appeals for the Federal Circuit, the appellate court entrusted with hearing virtually all U.S. patent appeals, has never declared such sequences to be non-patentable subject matter. For more than a century, patents have issued on isolated versions of naturally occurring substances other than DNA.

Many believe that gene patents are crucial to the modern biotechnology industry. On the other hand, many researchers and clinicians feel that gene patents, particularly human gene patents, are commonly unnecessary to spur innovation and in fact interfere significantly with scientific and technological progress, whether by slowing or diverting research, impeding the provision of diagnostic tests, or generally increasing costs for clinical and scientific work.

The patents at issue in Myriad make such concerns particularly poignant. These patents relate to BRCA1 and BRCA2, genes associated with a predisposition to breast cancer. The obvious public interest in ready access to cancer diagnosis helps account for the fact that petitioners’ lead lawyers are not the normal high-priced advocates for a private company accused of patent infringement. Instead, those lawyers work for the American Civil Liberties Union Foundation, an organization more commonly associated with battles for civil rights than rights in technological innovations.

While society should be careful about its uses of genetic testing and its efforts to modify the genome, some people overreact when dealing with DNA. Consider two recent examples reported in the media. A genetic cancer test. In a fascinating series on genetics in medicine, Gina Kolata reported in the New York Times on a genetic test... Read the rest of this entry »

Editor’s note: The current issue of Health Affairs is a thematic volume focusing on the President’s Emergency Plan For AIDS Relief (PEPFAR). Last week’s 19th International AIDS Conference in Washington, D.C. convened 25,000 scholars, activists, practitioners, policy makers, and members of the general public; people living with HIV and people living without the virus; students,... Read the rest of this entry »

Just four years ago, only two people in the world had their genome sequenced:  James D. Watson (co-discoverer of the structure of DNA) and J. Craig Venter (former President of the firm that mounted a private-sector rival to the Human Genome Project).  There are now many thousands of such people.  At genome meetings, scientists are... Read the rest of this entry »

Editor’s note: Kathryn Gilbert, a J.D. candidate at the University of Michigan Law School, is a coauthor of this post, in addition to Jill Horwitz and Helen Levy (photos and linked bios above). The case that will decide the fate of the most important piece of health care legislation in the past fifty years has,... Read the rest of this entry »

If one were to try and identify what issue has most roiled the biomedical community in the past few months it is surely the effort to censor two papers describing genetic modifications of the H5N1 flu virus. Background.  Last December, the U.S. National Science Advisory Board for Biosecurity (NSABB) was asked by the U.S. National... Read the rest of this entry »

Planned and unplanned disruptions in production of drugs are behind an overwhelming share of drug shortages.  Stockpiling the finished product has been proposed as a solution for preventing future shortages.  The general idea is that the federal government would purchase and stockpile select drugs, just as it does with vaccines and anti-bioterrorism agents.  This would... Read the rest of this entry »

“A child is not a small adult,” but an adolescent is not a large child.  Adult oncologists, reluctant to care for cancer patients under the age of 16, believe that adolescent and young adult (AYA) cancer patients should be within their purview.  We believe younger cancer patients are a special group needing special attention, even... Read the rest of this entry »

In the December Health Affairs Narrative Matters essay, multiple sclerosis patient Maran Wolston describes how she lost trust in her physician when she found out he was receiving payments from drug companies. Wolston says she was fortunate to be able to look up these payments in a Minnesota state database, and she applauds the establishment of... Read the rest of this entry »

In the newest Health Affairs Narrative Matters essay, a seventeen-year-old West African immigrant who’s off to college says her facial bruising was inflicted by her father, and a young pediatrician learns about — and rethinks — the process of reporting child abuse and working with Child Protective Services. The essay, “Oh, My Father Hit Me,”... Read the rest of this entry »

If you’re traveling over the long weekend, you’ll want to take along some reading material. While some might reach for a good novel by John Grisham or Dan Brown, the health policy blogs in this edition of the Health Wonk Review tackle equally compelling mysteries. Was the Medicare Trustees report really that gloomy? If Workers... Read the rest of this entry »

The challenge of reining in the rising costs of the Medicare Program is particularly thorny because it confronts a recalcitrant societal tension between the necessity for cost control and the value of open-ended technology use for life extension in the later years. That tension is becoming more deeply entrenched because a growing number of older... Read the rest of this entry »

For the past two years, debate as to whether health reform would result in rationing has underscored the contradiction between the health care Americans would like to have and what we’re actually willing to pay for it.  One may note that the terms budgeting and rationing are synonymous – especially today in an era of... Read the rest of this entry »

In “Shock Me, Tube Me, Line Me,” a Narrative Matters essay in the February 2010 issue of Health Affairs, emergency physician Boris Veysman sets forth his own version of an advance directive and challenges common perceptions about care at the end of life. An excerpted version of Veysman’s essay appears in today’s Washington Post Health... Read the rest of this entry »

As uncomfortable as it is for many Americans to accept, allocation issues are a permanent feature of our health care system, “reformed” or not.  Who should get the H1N1 flu vaccine first? In a flu pandemic or a biological disaster, who should be put on respirators and who should not?  These hard choices are realities,... Read the rest of this entry »

The newly released November-December 2009 edition of Health Affairs features a series of articles on the challenges posed by the HIV/AIDS pandemic.  The articles focus on steps policymakers can take to change the dynamics of the pandemic so that millions of lives will be saved, infections prevented, and overall costs made more affordable. Publication of the... Read the rest of this entry »

Editor’s Note: The post below by Merrill Goozner first appeared on The Values and Health Reform Connection, a site run by the Hastings Center and supported by Health Affairs as a media sponsor. Goozner’s post can also be found on his blog GoozNews on Health. The Values and Health Reform Connection grew out of the Hastings Center Publication “Connecting... Read the rest of this entry »

By the fourth sentence of the preface to The Silent World of Doctor and Patient, Jay Katz has quietly issued a startling challenge to a fundamental principle of the doctor-patient relationship. He writes: It took time before I appreciated fully the oddity of physicians’ insistence that patients follow doctors’ orders. During my socialization as a... Read the rest of this entry »