May 7, 2010
By Leah Voigt*
NIH Director Tells Panel of Plans for New Stem Cell Research Center
The National Institutes of Health (NIH) plans to start a new center on its campus to study induced pluripotent stem (iPS) cells—human stem cells with qualities similar to embryonic stem cells—NIH Director Francis Collins said during an appropriations hearing this week.
Collins testified before the Senate Appropriations subcommittee responsible for the U.S. Departments of Labor and Health and Human Services (HHS) on NIH's proposed $32.1 billion budget for fiscal year (FY) 2011, an increase of 3.2% or $1 billion compared to 2010. Collins' formal testimony was similar to what he presented before the Labor-HHS subcommittee's House counterpart on April 28, 2010.
While Collins said the proposed increase during a tight budget year indicates President Barack Obama's commitment to science, scientists who apply for NIH grants are expected to take a significant hit in their success rates (i.e., rate of receiving funds) because of the drop-off in funding that was added with the 2009 economic stimulus law. The extra $10.4 billion NIH received over FY 2009 and 2010 moves NIH's budget to about $36 billion in FY 2010, compared to the proposed $32.1 billion in
FY 2011. The grant application success rates, which already dropped from 25% to 20%, are expected to dip as low as 15% in FY 2011, according to Collins.
Collins's announcement about the new iPS center came during a discussion on embryonic stem cell research. The discovery of iPS cells—in which scientists converted adult skin cells to pluripotency, meaning they can differentiate into other cell types—was touted as a possibility to sidestep the ethical controversy that surrounds embryonic stem cell research. However, scientists largely have said work on all types of stem cells must continue as embryonic stem cells are still considered the gold standard. The specific agenda for the iPS cells would be to push for clinical applications, Collins said.
Jeannie Baumann, NIH Director Tells Panel of Plans for New Stem Cell Research Center, BNA’s Health Care Daily Report (May 6, 2010) (note: registration is required to view this content).
Cure Found to HIV ‘Elite Controllers’
Researchers believe they have found an important clue in the mystery of the elite controllers—patients whose HIV infections progress only slowly, if at all, to full-blown AIDS. A combination of computer modeling and human studies suggests that the elite controllers have killer T cells that are more sensitive to fast-mutating viruses such as HIV, according to the researchers in an online article in Nature. They noted that the result appears to be a more robust immune response in the early stages of HIV infection.
Those T cells arise because—perhaps paradoxically—the immune system molecules that prime them do a relatively poor job, failing to present large numbers of self-proteins, the researchers said. The finding derives from the observation that some immune system gene variants—or HLA class I alleles—are "markedly enriched" in elite controllers, the researchers said. The strongest association is for an allele dubbed HLA-B57, so the researchers analyzed its role in preparing T cells in the thymus. In general, the HLA molecules bind to and then present a range of self-proteins to the nascent T cell; a cell that reacts too strongly to a self-protein is prompted to self-destruct.
Michael Smith, Cure Found to HIV ‘Elite Controllers’, MedPage Today
(May 6, 2010).
Doctors at Religious Hospital Face Ethical Conflicts Over Care
One in five primary care physicians working in religiously affiliated healthcare organizations has experienced a conflict over faith-based patient care policies, according to a new study in the Journal of General Internal Medicine. The findings, based on a nationwide survey of 446 family physicians and internists, appear to be the first to document how frequently doctors disagree with institutional policies in areas such as reproductive and end-of-life care, said the study's lead author.
Most of the physicians reporting conflicts worked in Catholic hospitals, which account for 12.5% of all U.S. community-based hospitals and 15.5% of hospital admissions, according to the Catholic Health Association of the United States. Catholic hospitals are required to follow the U.S. Conference of Catholic Bishops' religious directives on medical care that bar contraception, abortion, and sterilization and, in many instances, rule out ending artificial hydration and nutrition.
When conflicts arise, 86% of surveyed physicians said they would encourage patients to seek the recommended care at another hospital. Ten percent said they would offer an alternative treatment that could be delivered at the religious hospital, and 4% endorsed violating the hospital's policy to provide the care. Referring patients to another hospital may not be in the patient's best interests, said the study’s lead author, particularly for time-sensitive interventions such as emergency contraception. Referrals also can impede access to care for patients who live in underserved rural areas or lack access to transportation, she said.
Kevin B. O’Reilly, Doctors at Religious Hospital Face Ethical Conflicts Over Care, Am. Med. News (May 3, 2010).
Teaching Doctors the Price of Care
Doctors in training have traditionally been insulated from details about the cost of tests and treatments they prescribe. But concerns about rising health costs are slowly changing that. When Dr. Ryan Thompson, an internist, was a medical resident at Massachusetts General Hospital in Boston a few years ago, he worried that he and his fellow trainees were not learning about the cost of medical treatments, the financing of healthcare, and the impact of high medical bills on their patients.
So, with the help of faculty members at Harvard Medical School and another resident, Thompson organized an elective course for residents on the topic. In one session, "I made up a kind of 'Price Is Right' game," he recalled. "I got the bill of a patient and actually went through it," asking colleagues to guess the cost of commonly ordered tests, like CT scans. Their answers "were all over the map," he said. "They had no idea."
Doctors in training have traditionally been insulated from information about the cost of the tests and treatments they order for patients—in fact, for decades, the subject was virtually taboo when professors and trainees discussed treatment decisions during hospital rounds. During four years of medical school, students learn to order tests and treatments based on their knowledge of diseases and of scientific evidence. Until recently, most schools included little information on financial factors, like how the insurance system works and how treatment costs affect patients' behavior. As a result, most physicians enter practice with little sense of how to make the most cost-effective choices for patients, or how their own decisions affect the patient's—and the nation's—medical bills.
Escalating costs and the national debate over the healthcare overhaul are forcing medical schools and residency programs to grapple with teaching about the financial side of their profession. Accrediting organizations now require such teaching, and students and residents recognize that they need to understand finances as well as blood tests.
According to a recent survey by the Association of American Medical Colleges (AAMC), about 60% of 102 American and Canadian medical schools include some material on healthcare costs, although the time they devote to it varies widely. Some medical schools have met the challenge by creating courses for first- or second-year students on health policy or professional responsibility that include information about treatment costs and insurance.
At the Mount Sinai School of Medicine in New York City, students can get hands-on lessons about the impact of treatment costs on patients by volunteering on Saturdays at the East Harlem Health Outreach Program, a student-run free clinic for uninsured residents of a low-income neighborhood near the school. Medical students evaluate patients, choose which drugs are prescribed, arrange care for patients who need to see a surgeon or other specialist, and collaborate with a social worker to help those who need social services or assistance paying for medicine. They also sit on the steering committee and are in charge of researching and updating the clinic's formulary, a stock of inexpensive, cost-effective drugs that are purchased from the hospital pharmacy.
Susan Okie, Teaching Doctors the Price of Care, Kaiser Health News
(May 4, 2010).
Generic Rx Industry Group's Leader Departs After Eight Years at the Helm
Kathleen Jaeger will leave her position as president and chief executive officer (CEO) of the Generic Pharmaceutical Association (GPhA)
on June 30, 2010, the organization announced earlier this week. Jaeger joined GPhA in 2002, shortly after the group was founded following the merger of three industry trade organizations: the Generic Pharmaceutical Industry Association, the National Association of Pharmaceutical Manufacturers, and the National Pharmaceutical Alliance. She will remain as an adviser to GPhA through the end of 2010.
In April, a key generic drug company, Teva, announced that it had resigned from GPhA, stating that the association no longer appropriately reflects the policy priorities or market realities of the company. Teva said its mission is to provide access to medicine and it will continue to pursue this goal outside of GPhA. Jaeger's departure from the major generics lobby comes as the major lobbying group for brand-name drugs is facing its own leadership transition. In February, the Pharmaceutical Research and Manufacturers of America (PhRMA) said Billy Tauzin will leave his position as PhRMA's president and CEO as of June 30, 2010.
Both departures of industry group leaders come at a time when the generic and brand pharmaceutical industries face changes due to the healthcare reform legislation (Pub. L. No. 111-148) signed into law by President Obama in March. The reform legislation's provisions affecting the pharmaceutical industry include a plan to close the Medicare drug benefit coverage gap, a requirement to disclose industry payments to doctors, increased rebates for companies that participate in the Medicaid program, and a new pathway for approval of follow-on biologic drugs or biosimilars.
Bronwyn Mixter, Generic Rx Industry Group's Leader Departs After Eight Years at the Helm, BNA’s Health Care Daily Report (May 5, 2010)
(note: registration is required to view this content).
Panel Criticized as Overstating Cancer Risks
A dire government report on cancer risks from chemicals and other hazards in the environment has drawn criticism from the American Cancer Society, which says government experts are overstating their case.
The government’s 240-page report, published online Thursday by the President’s Cancer Panel, says the proportion of cancer cases caused by environmental exposures has been “grossly underestimated.” It warns of “grievous harm” from chemicals and other hazards, and cites “a growing body of evidence linking environmental exposures to cancer. ”Children are especially vulnerable, the panel says. It urges the government to strengthen research and regulation, and advises individuals on ways to limit exposure to potential threats like pesticides, industrial chemicals, medical X-rays, vehicle exhaust, plastic food containers, and too much sun.
A cover letter urges President Obama “most strongly to use the power of your office to remove the carcinogens and other toxins from our food, water and air that needlessly increase health care costs, cripple our nation’s productivity, and devastate American lives.”
Nearly 80,000 chemicals are in use in the United States, and yet only a few hundred have been tested for safety, the report notes. It criticizes the nation’s regulatory approach, calling it reactionary rather than precautionary, which means that the government waits for proof of harm before taking action, instead of taking preventive steps when there is uncertainty about a chemical. Regulation is ineffective, the panel says, in part because of inadequate staffing and financing, overly complex rules, weak laws, uneven enforcement, and undue industry influence.
The report looks at contaminants from a variety of sources: industry, agriculture, air and water, medical imaging, and contaminated military sites. It also considers natural hazards, like radon gas in homes and arsenic in drinking water. The report concludes, “At this time, we do not know how much environmental exposures influence cancer risk.”
The cancer society estimates that about 6% of all cancers in the United States—34,000 cases a year—are related to environmental causes (4% from occupational exposures, 2% from the community or other settings).
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.
*We would like to thank Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.