Saturday, September 24, 2005
U.S. Food and Drug Administration Commissioner Lester Crawford abruptly resigned on Friday after a bruising fight over whether the agency would approve over-the-counter sales of a morning-after pill and a string of drug-safety controversies.
Crawford's resignation takes effect immediately, health officials said. They offered no reason for his sudden departure less than three months after he was confirmed for the job.
President George W. Bush asked National Cancer Institute Director Andrew Von Eschenbach to serve as acting FDA commissioner, the White House said.
Crawford won a contentious confirmation battle in the Senate after Health and Human Services Secretary Mike Leavitt assured Senate Democrats the FDA would act on over-the-counter sales of the morning after pill Plan B by Sept. 1.
But he came under fresh attack in late August when the FDA indefinitely postponed a ruling on whether Barr Pharmaceuticals Inc. (BRL.N: Quote, Profile, Research) could sell the Plan B contraceptive without a prescription. The agency's top women's health official resigned in protest.
The FDA also faced a string of drug safety controversies during Crawford's tenure. Some critics charged the agency with being too slow to react to signs of serious side effects from Merck & Co. Inc.'s (MRK.N: Quote, Profile, Research) recalled painkiller Vioxx and other medicines.
Thanks to Barbara Kincaid for sending along a link to Jones Day's announcement about the IRS's new proposed intermediate-sanction regulation. According to the firm:
On September 8, 2005, the IRS released a set of Proposed Regulations that set forth the standards the IRS proposes to use to determine whether to revoke the § 501(c)(3) status of an organization that has engaged in a transaction that constitutes both traditional private inurement and an excess benefit transaction. Under these Proposed Regulations, organizations that attempt in good faith to follow good corporate governance and compliance practices both before and after a private inurement problem occurs will survive with their tax-exempt status intact. Those organizations that do not follow good corporate governance and compliance practices will lose their tax-exempt status.
Want to know more? Here's what one of my favorite sites (www.Regulations.gov) has on it:
|TITLE:||Standards for Recognition of Tax-Exempt Status if Private Benefit Exists or If an Applicable Tax-Exempt Organization Has Engaged in Excess Benefit Transaction(s)|
|SUBJECT CATEGORY:||Income and excise taxes: Excess benefit transactions|
|View this Regulation in HTML Format|
|View this Regulation in PDF Format|
|CFR Citation:||26 CFR 1, 53|
|Published:||September 09, 2005 [FR Doc. 05-17858]|
|Comments Due:||December 08, 2005|
|How to Comment:||Submit a Comment on this Regulation|
Send submissions to: CC:PA:LPD:PR (REG-111257-05), room 5203, Internal Revenue Service, POB 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to: CC:PA:LPD:PR (REG-111257-05), Courier"s Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC. Alternatively, taxpayers may submit comments electronically via the IRS Internet site at http://www.irs.gov/regs or the FederaleRulemaking Portal at http://www.regulations.gov (IRS-REG-111257-05). A public hearing may be scheduled if requested.
Friday, September 23, 2005
So, here I am worrying about whether there will be a sufficient supply of flu vaccine this year and along comes this article in the New York Times examining two recent studies concerning the efficacy of the vaccine. I guess I can start worrying about this now. According to the Times,
Just as governments around the world are stockpiling millions of doses of flu vaccine and antiviral drugs in anticipation of a potential influenza pandemic, two new surprising research papers to be published Thursday have found that such treatments are far less effective than previously thought.
"The studies published today reinforce the shortcomings of our efforts to control influenza," wrote Dr. Guan Yi, a virologist at the University of Hong Kong, in an editorial that accompanied the papers. The two studies were published early online by The Lancet, the London-based medical publication, because of their important implications for the coming flu season.
In one paper, international researchers analyzed all the data from patient studies on the flu vaccine performed worldwide in the last 37 years and discovered that vaccines showed at best a "modest" ability to prevent influenza or its complications in elderly people.
"The runaway 100 percent effectiveness that's touted by proponents was nowhere to be seen," said Tom Jefferson, a researcher in Rome with the Cochrane Vaccine Fields project, an international consortium of scientists who perform systematic reviews of research data.
"There is a wild overestimation of the impact of these vaccines in the community," he said. "In the case of a pandemic, we are unsure from the data whether these vaccines would work on the elderly."
In the second paper, researchers from the Centers for Disease Control and Prevention in Atlanta found that influenza viruses, particularly those from the dreaded bird flu strain, had developed high rates of resistance to the only class of cheap antiviral drugs available - drugs mainly used to treat flu once patients have caught it. These resistance rates have increased rapidly since 2003, particularly in Asia.
"We were alarmed to find such a dramatic increase in drug resistance in circulating human influenza viruses in recent years," said Dr. Rick Bright of the disease control centers. "Our report has broad implications for agencies and governments planning to stockpile these drugs for epidemic and pandemic strains of influenza."
For those of you in the Washington, DC area with an interest in bioethics, this looks like a terrific event --
THE STUDIO THEATRE’S DYNAMIC 2005-2006 SEASON BEGINS!
TED VAN GRIETHUYSEN AND TOM STORY STAR IN CARYL CHURCHILL’S ELECTRIFYING A NUMBER
The Evening Standard of London
A NUMBER INFORMATION
Director and Designers: Joy Zinoman (Director), Debra Booth (Set Designer), Michael Lincoln
(Lighting Designer), Brandee Mathies (Costume Designer), Gil Thompson (Sound Designer),
Erik Trester (Projections).
Where: The Mead Theatre
Dates: September 7 – October 16, 2005
Performances: Wednesday – Saturday: 8:00pm, Sundays: 7:00pm, Matinees: Saturday
and Sunday 2:00pm, Select Tuesdays: 8:00pm (September 20 and 27, October 11)
Ticket Prices: $32.00 - $52.00
Pay-What-You-Can: Saturday, September 10, 2:00pm. Tickets go on sale two hours before the performance on a first-come, first-served basis.
Sign Interpreted Performance: Saturday, October 15 2:00pm.
THE STUDIO THEATRE INFORMATION
Student Rush: half-price tickets for full-time students are available one-half hour before curtain on a seating available basis (except Saturday evenings).
Groups: Discount rates available for parties of 10 or more. Call the Group Sales Manager at 202-232-7267.
Accessibility: All performances are fully accessible to accommodate patrons with special needs. FM listening assistive system available, call for schedule for sign-interpreted performances. Accessible seats available by reservation. Call the Box Office at 202-332-3300 or V/TTY 202-667-8436.
Parking: Please call the Box Office for parking information.
Metro Stops: Red Line: Dupont Circle Orange
Contact Information: Tickets: 202-332-3300 V/TTY: 202-667-8436 Fax: 202-332-1187
Administration: 202-232-7267 Admin. Fax: 202-588-5262
Web site: www.studiotheatre.org E-mail: email@example.com
Collaborations of Doctors, Hopsitals, Insurers, and Employers Are Bringing Electronic Record Keeping to Small Doctors' Offices
A large collaboration of doctors, hospitals, insurers and employers are making modern information technology accessible to hundreds of thousands of small doctors' office around the nation. According to the N.Y. Times, the Hudson Valley effort consisting of around 500 doctors, hospitals, insurers and employers is being watched as a potential model to bring this technology to small doctors' offices. These groups pool their resources and knowledge to create a web-based central database in which a doctor only needs a few PCs, a high speed internet connection, and to pay a monthly subscription fee of $500 to $600.
Electronic records, particularly one shared online by different doctors and hospitals, can improve the quality and safety of patient care by reducing errors that kill tens of thousands of patients each year. Dr. Heslin, a family physician in Saugerties says that "the large groups can afford the software.. for the onesies and twosies, small groups like ours, there is no profit margin."
With very little financial help from Congress and the Bush Administration, big organizations such as Kaiser Permanente, the Mayo Clinic and many medical centers are spending billions to convert to electronic records. Health and Human Services Secretary Mike Leavitt says that Katrina disaster "powerfully demonstrated the need for electronic health records." Government and health officials had to rush to build an electronic database of prescription drug records for hundreds of thousands of people who lost their records in the storm.
Medicare and some employers, are paying incentives to medical providers that achieve better efficiency and patient care through improved information management. However, smaller medical practices lack the computerized records that help them qualify, primarily due to the huge up-front costs as as high as $30,000 for each doctor, as well as support and training. Thus, these type of collaborations can make the technology and use more accessible to small doctor practices. The Taconic group received a $100,000 grant from the eHealth Initiative, a national nonprofit organization which strives to bring the medical profession into the modern digital era. The Taconic network has also received $1.5 million from the federal Agency for Healthcare Research and Quality, to pay for an evaluation of the system by an independent researcher.
Thanks to Lindley Bain, SMU 3L, for her assistance with this post. [tm]
Ethical Considerations for Research on Housing-Related Health Hazards Involving Children: Public BriefingIn April the U.S. Environmental Protection Agency cancelled a study of how young children are exposed to indoor pesticides and other household chemicals after critics argued that child participants were intentionally placed at risk and parents were not fully informed of the study's potential dangers. A recent study of lead-based paint abatement by the Kennedy Krieger Institute in Baltimore also drew sharp criticism for its work with child participants [see Grimes v. Kennedy Krieger Institute, Inc., 366 Md. 29 (2001) (PDF)]. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children, a new report from the National Research Council and the Institute of Medicine of the National Academies, outlines how to conduct such research in a way that ultimately improves child health, ensures that child participants do not face inappropriate risks, and fully informs their parents. The report will be released at a public briefing.
Thursday, September 22, 2005
The Wall Street Journal reports that the FDA has approved the final components of Guidant Corp.'s Latitude Internet-based system of monitoring implanted heart devices for use in the home. The Latitude Communicator and secure data storage system is an in-home monitoring device that wirelessly reads patient information provided by devices such as pacemakers and defibrillators and transmits the data to a secure Internet server where physicians can access it. The in-clinic use of this system has been available since November.
This past summer, Guidant recalled tens of thousands of its defibrillators and pacemakers due to malfunctions. In June, the FDA issued a safety alert about problems with Guidant heart devices due to some units short-circuiting. Johnson & Johnson is to buy Guidant for about $25.4 billion, pending approval by the FTC in October.
Thanks to Lindley Bain, SMU 3L, for her help with this post. [tm]
The Cornell Legal Information Institute is a terrific source for a wide variety of legal issues including background information on upcoming Supreme Court cases. Two weeks from today, on October 5th, the Court (presumably with the new Chief Justice Roberts presiding) will be addressing the issue of Oregon's Death with Dignity Act in the Gonzales v. Oregon. The Cornell LII has a brief and extremely helpful overview of the case and the many complex issues that is raises. It concludes that Oregon will probably be seeing a change in its law (and this without the C.J. Roberts factor considered explicity):
On its face, Gonzales v. Oregon (formerly Oregon v. Ashcroft), 368 F.3d 1118 (9th Cir. 2004), cert. granted, 125 S. Ct. 1299 (2005), is an intriguing case because it presents a clash of federal and state spheres of influence. On the one hand, the Attorney General has taken the position that Oregon's decision to permit physicians to distribute controlled substances for physician-assisted suicide is contrary to federal law. On the other hand, Oregon argues that the Attorney General has misinterpreted the CSA to invalidate state law that represents the democratic choice of the people of Oregon in the medical arena. These views present two different perspectives of the concept of federalism, while also implicating serious moral and policy concerns. Given framing of the central issues, the Court will not likely address this question on policy or moral grounds. The plain language of the CSA, Congressional intent and administrative law will all inform the Court's decision. The Court will likely avoid such slippery slope issues if favor of uniformity in the implementation of the CSA, perhaps a more preferable outcome to variable multi-state regulation. The safe route to resolving this case with the minimal amount of controversy suggests that change may be on the horizon for the Oregon Act.
Thanks to TalkLeft for this website and update. [bm]
Wednesday, September 21, 2005
FYI: For those of you on the teaching market -- two wonderful opportunities at Georgia State University's College of Law in Health Law.
Georgia State University’s College of Law seeks highly qualified applicants for two full-time faculty positions in health-related legal disciplines beginning with the 2006-2007 academic year. These faculty positions will support the development of the College’s health-related law program and its Center for Law, Health & Society (http://law.gsu.edu/clhs/ ).
One faculty position is in the focus area of public health law; the second faculty position is in the focus area of law related to the health sciences, health technology, and research ethics. Applicants should have an excellent academic background, strong experience in the focus area applied for, and a proven record of (or clear demonstrated potential for) successful teaching, scholarship, and service. Rank is open and commensurate with experience.
The ideal candidate for the first faculty position in public health law will have strong interdisciplinary research and teaching interests and be able to collaborate actively with research faculty in Georgia State University’s Partnership for Urban Health Research under the direction of the Institute of Public Health (see http://urbanhealth.gsu.edu/home.html).
The ideal candidate for the second faculty position in law related to health sciences, technology, and research ethics (including, e.g., biotechnology, genetics, scientific evidence, development of scientific advances, intellectual property) will have strong interdisciplinary research and teaching interests and be able to collaborate with faculty and administrators in other related University units and with other academic, business, government, or community partners in Atlanta or elsewhere.
Part of a comprehensive research university, the College of Law is a dynamic urban-centered law school located in the heart of Atlanta with approximately 650 full- and part-time law students. We encourage applications from candidates who would diversify our faculty. Georgia State University, a unit of the University System of Georgia, is an equal opportunity educational institution and an equal opportunity/affirmative action employer.
Applications and nominations should be submitted to: Professor Charity Scott Chair, Faculty Recruitment Committee Director, Center for Law, Health & Society College of Law Georgia State University P.O. Box 4037 Atlanta, GA 30302-4037 Telephone: 404-651-2083 E-mail: firstname.lastname@example.org
The University of Southern California Gould School of Law announced that QueensCare, a leading provider of healthcare to uninsured and low-income families in Los Angeles County, has given the school $1.5 million to establish the Scott H. Bice Chair in Healthcare Law, Policy and Ethics. According to USC's press release,
The endowed chair is named in honor of the law school’s former dean, Scott Bice, who is currently a professor at USC Law.
The chair will significantly enhance USC Law’s leadership in producing high-quality education and research on the policy, legal and ethical issues surrounding healthcare, said Matthew Spitzer, USC Law dean. After a rigorous national search, the position is expected to be filled by a scholar with a strong record of national leadership in health care law and ethics research and teaching.
Once installed, the Scott H. Bice Chair in Healthcare Law, Policy and Ethics will convene scholarly explorations of needs, resources and determinants for improving healthcare for the underserved populations QueensCare serves. Such research would also impact national healthcare and policy analysis and could strengthen advocacy efforts on behalf of underserved communities.
Congratulations to USC Gould School of Law - what a wonderful chair! [bm]
online version of the New England Journal of Medicine (NEJM) contains
results of an important study of five antipsychotic medications, which are
drugs used to treat schizophrenia and other major mental illnesses. The study, conducted by psychiatrist Jeffrey
Lieberman and colleagues across the U.S., looked at the 18-month treatment
outcomes for patients randomly assigned to one of four newer (and comparatively
expensive) “second-generation” antipsychotic medications and one older (and
inexpensive) “conventional” drug. The
print version of the study will appear in the September 22 edition of NEJM.
The key finding of the study: most patients in each group stopped their assigned medication because of ineffectiveness, side effects, or other problems. The older drug (perphenazine) appeared similar in effectiveness to three of the newer drugs. The groups of patients assigned to the fourth second-generation drug (olanzapine) stayed with treatment more consistently, but they also experienced greater weight gain, increases in blood sugar levels, and increases in blood lipid levels.
may have important implications for patients who received treatment through
programs (e.g., Medicaid) where concern about funding is necessarily an
issue. You can locate the online version
of the NEJM study here:
editorial discussing the significance of the study appears here:
A useful summary of the article (“Little Difference Found in Schizophrenia Drugs,” by Benedict Carey), appears in the September 20 edition of the New York Times. This article includes comments from Dr. Lieberman and pharmaceutical company spokesmen.
Thanks to my fine colleague Douglas Mossman for this excellent post. [bm]
Tuesday, September 20, 2005
From the Sarbanes-Oxley Act Task Force over at the American Health Lawyers Association comes this link to Moody's Investor Service report, "Governance of Not-for-Profit Healthcare Organizations" (PDF). As described by the Task Force in their e-mail alert:
When the AHLA published Tax-Exempt Bonds: Is Sarbanes-Oxley Relevant? earlier in 2005, the authors, Paul Gilbert and Mark Pickrell, argued that corporate-governance issues should be relevant, and would become increasingly relevant, for not-for-profit bond issuers and other bond-market participants. Moody's Special Comment bolsters their argument that corporate-governance issues are being examined by ratings agencies and will, therefore, remain of significance to bond issuers for the foreseeable future. The Moody's report also shows that, although this ratings agency is explicitly examining corporate-governance issues in its bond-issuer research, the quantifiable effect of specific corporate-governance practices on issuer ratings, and on the interest rates of specific bond issuances, is yet to be determined.
Jon Eisenberg, one of the attorneys who respresented Michael Schiavo in the some of the federal court litigation, has written a new book. Entitled, "Using Terri: The Religious Right's Conspiracy to Take Away Our Rights," the book provides insight into the ongoing battles concerning the right to die/refuse medical treatment. Professor Samuel R. Bagenstos of the excellent Disability Law Blog provides a brief critique:
The book isn't without its flaws: Eisenberg puts himself into the story too much, and some of the writing is tendentious. Disability rights opponents of the right to die come across as deluded tools of the Religious Right, rather than as people with well-grounded concerns (but perhaps a wrongheaded policy prescription). But if you want a forceful lawyer's brief for the right-to-die side of the Schiavo case (in language the lay reader can easily understand), you could do a lot worse than this book.
Amazon.com provides brief reviews by Publishers Weekly and Arthur Caplan. [bm]
A new study appearing in Journal of Epidemiology and Community Health may help explain why men have a lower life expectancy world-wide. No it isn't related to their engagement in more physically demanding jobs or risk-taking. Apparently patriarchy is to blame. According to Health News Daily,
British researchers analyzed rates of female murders and male death rates from all causes in 51 countries in Europe, Asia, Australasia, and North and South America. The prevalence of violence against women was used to indicate the extent of patriarchal control in each of the countries. Socioeconomic factors were also taken into consideration.
The study found that women lived longer than men in all 51 countries. The study also found that those countries with higher rates of female murders (indicating higher levels of patriarchy) also had higher rates for male death and shorter male life expectancies, compared to countries with lower female murder rates, the researchers said.
In fact, statistical analysis showed that variations between countries in rates of violence against women accounted for close to half (49 percent) of the variation in male death rates, the researchers noted.
"Our data suggest that oppression and exploitation harm the oppressors as well as those they oppress," researchers at the University of Liverpool concluded.
Monday, September 19, 2005
Professor of Law, Executive Director & Faculty Fellow, Center for the Study of Law, Science, & Technology, GARY E. MARCHANT of Arizona State University College of Law, has written an article discussing the potential commercialization of DNA. The article is entitled,"Property Rights and Benefit-Sharing for DNA Donors?" and appears in 45 Jurimetrics 154. ABSTRACT: The traditional assumption in most genetic research is that the donors of genetic material used in research act altruistically and are entitled to no property rights or direct benefit-sharing in the fruits of the research. This traditional assumption is now being challenged from several different directions. Some international ethics guidelines, advocacy organizations for families suffering from genetic diseases, and special populations such as Indian tribes are all pushing for greater control, rights, and benefit-sharing for genetic donors. The failure to resolve the tensions between these new demands and the traditional assumption of genetic research has the potential to create a bottleneck in the supply of genetic samples vital to the advancement of genetic research. This Article traces the recent controversies and trends that are challenging the traditional assumption that DNA donors in genetic research have no property or other rights in their donated material and outlines some alternative approaches for resolving this problem. You may download the article here:
Professor of Law, Executive Director & Faculty Fellow, Center for the Study of Law, Science, & Technology, GARY E. MARCHANT of Arizona State University College of Law, has written an article discussing the potential commercialization of DNA. The article is entitled,"Property Rights and Benefit-Sharing for DNA Donors?" and appears in 45 Jurimetrics 154.
The traditional assumption in most genetic research is that the donors of genetic material used in research act altruistically and are entitled to no property rights or direct benefit-sharing in the fruits of the research. This traditional assumption is now being challenged from several different directions. Some international ethics guidelines, advocacy organizations for families suffering from genetic diseases, and special populations such as Indian tribes are all pushing for greater control, rights, and benefit-sharing for genetic donors. The failure to resolve the tensions between these new demands and the traditional assumption of genetic research has the potential to create a bottleneck in the supply of genetic samples vital to the advancement of genetic research. This Article traces the recent controversies and trends that are challenging the traditional assumption that DNA donors in genetic research have no property or other rights in their donated material and outlines some alternative approaches for resolving this problem.
You may download the article here:http://papers.ssrn.com/paper.taf?abstract_id=740804
Sunday, September 18, 2005
According to federal officials, Medicare monthly premiums for doctor visits and outpatient care will jump next year from $78.20 to $88.50, federal officials announced September 16th. Knight-Ridder describes further the increase and the reason behind it, reporting :
The 13.2 percent increase is lower than last year's record-high 17.4 percent spike, but nevertheless drains more cash from the Social Security checks of Americans 65 and older, from which Medicare premiums typically are drawn.
The premium hike will offset higher program spending that's due to more intensive patient care, said Herb Kuhn, the director of the Center for Medicare Management at the Centers for Medicare & Medicaid Services. Included in that spending is more frequent use of hospital outpatient services, doctor visits, lab tests, imaging and other minor medical procedures.
"They're all up. They're all up substantially, and we're trying to understand how much value we're getting for that, and we just don't have a good handle on that," Kuhn said.
The higher premiums also will help shore up Medicare's Supplementary Medical Insurance trust fund, which pays a portion of physician and outpatient care. Legislation that Congress passed in recent years to increase what Medicare pays for physician services has left trust fund assets "below where we would normally like it to be," said Richard Foster, Medicare's chief actuary.
If Congress increases the physician payment level this year, Medicare's 2007 premiums for doctors' services probably will increase as well, Foster said.
The Detroit News ran a story (9/11/05) about a telephone service run out of Dallas that allows patients to get a diagnosis and prescription over the phone from a doctor they will never see:
A quick phone call and about $55 can snag ailing patients a diagnosis and prescription -- from a doctor they can't see and will never meet.
A Dallas company called TelaDoc is moving into the Midwest and Metro Detroit with a controversial service that provides medical consultations over the phone. The target: patients crunched for time and money, and fed up with waiting days for a doctor's appointment.
"Why should you have to wait two days to get two minutes with a doctor for allergies you had last year?" said Michael Gorton, TelaDoc's chief executive officer. "If you've got a routine issue and can't get into the doctor, we're there to bridge the gap."
The fledgling company links patients with doctors who make decisions based on an electronic medical history and symptoms described by the patient. For individuals, TelaDoc Medical Services costs $18 to join, and $4.25 a month. Each call to a doctor is $35. A return phone call is guaranteed within three hours.
TelaDoc's founders say the service is the next big thing in the growing market niche of quick and convenient medical care, in an era where patients already can go to Target for a checkup or pay extra for prompt service at the family doctor.
Call me crazy. Call me old-fashioned. This doesn't sound like a very promising way to deal with the cost and access issues in our health care system. [tm]
For medical-humanities types like me, this is the sort of essay we live for, press on our students, skip the praise and let the prose speak for itself: an essay in today's NY Times Magazine by Abraham Verghese (Joaquin Cigarroa Jr. Chair and Marvin Forland Distinguished Professor at the University of Texas Health Sciences Center, San Antonio): "Close Encounter of the Human Kind." [tm]