Saturday, September 3, 2005
Effect Measure has the run down of what the risks are and aren't after Katrina. They state,
During the anthrax episode, the Secretary of Health and Human Services Tommy Thompson repeatedly provided incorrect information to the news media on the number of spores required to produce an infection. The same misinformation was often repeated by public health authorities. Failure to communicate the fact that the risks from even a small number of spores could result in infection may have contributed to the deaths of two postal employees at the Brentwood facility in Washington, DC.
Misinformation from those who should know better is also occurring in the aftermath of hurricane Katrina. DHHS Secretary Leavitt, for example, has warned of the risk of "typhoid and cholera" as a result of contaminated water, while others have talked generally of mosquito-borne disease and the hazards caused by dead people and animals. It is time to separate the real risks from the phantom risks.
Diarrheal disease from contaminated water is a concern, but not cholera and probably not typhoid. In order to get these diseases the water has to be contaminated with the organisms that cause those diseases, neither of which is endemic in that region. What is more likely is gastroenteritis or hepatitis A from enteric viruses or bacteria. Most are spread by the fecal-oral route, which means they are not spread directly person to person. If they get in a contaminated, piped water supply they can cause an epidemic, because piped water is an efficient way to distribute pathogens to a population. But localized contamination of flood waters is not. Individuals can get serious diarrheal disease and even die of consequent dehydration, but there is not likely to be a point source epidemic of cholera or typhoid or even diarrheal disease, only sporadic cases (which may be relatively numerous but not epidemic in nature). Lack of clean water and food can produce a risk of diarrhea and dehydration and must be attended to quickly, but not to prevent an epidemic.
The entire article is very informative. [bm]
Friday, September 2, 2005
From pal Matt Wall in the general counsel's office at the Texas Hospital Association:
The Center for Law and the Public's Health at Georgetown and Johns Hopkins Universities is working to address legal issues related to the use of volunteer health professionals (VHPs) in response to the emergency circumstances in Louisiana, Mississippi, and Alabama:
There are lots of good links and valuable information on this page . . . . well worth checking out. [tm]
From the Boston Globe,
Hoping to avoid last year's flu vaccine shortage, the Centers for Disease Control and Prevention yesterday urged doctors and other health officials to give the first batch of flu shots to people at risk of severe complications. After Oct. 24, shots may be given to everyone who wants them as supplies last, the health agency said. The priority groups include people 65 and older who have underlying health conditions that put them at higher risk for flu complications, such as heart disease, asthma, diabetes, and other chronic ailments; people ages 2 to 64 with such underlying conditions; pregnant women; children ages 6 months to 23 months; healthcare personnel who give direct patient care; and residents of long-term care facilities.
The New York Times ran an editorial yesterday concerning pharmacy conscience clauses that was a great read. The editorial is by Florence A. Ruderman and she writes,
Allowing a pharmacist the right to refuse to fill a legal prescription, without simultaneous safeguards to ensure that the prescription can be filled promptly elsewhere or by someone else, surrenders the right of the majority to willful obstruction by a determined minority. It is important to realize that even with some legally specified safeguards for transfer or referral, a movement of this sort can have the effect of depriving many women of birth control. In small towns or rural areas, there may not be another pharmacy, or a woman may have no way to get to one that is far from her home. And other pharmacists may be unwilling to fill contested prescriptions, out of fear of becoming targets for boycotts or other hostile actions. This is a way to nullify the laws of the land - with a state-provided shield for doing so.
Clearly it is women who will be most directly and immediately affected. But the pharmacists' refusal movement threatens everyone. Similar tactics can be used to subvert or negate other laws and other rights that may be contrary to some individual's or group's moral or religious views. Bus drivers can refuse to stop near a fertility clinic; suppliers of ordinary products can refuse deliveries to such clinics; clerks can lose the registrations of civil unions. Such a movement in the name of individual conscience threatens democratic freedoms by encouraging small groups of zealots to impose their will on everyone else.
State legislatures should find the courage to resist these undemocratic tides. We should question nominees to federal courts and the Supreme Court about this issue - and we have a right to ask political leaders to speak out, now. If we don't, more of us may end up in the position I was in when the neighborhood pharmacy refused to fill my suffering father's prescription for morphine - desperately searching for options as a pharmacist righteously looks on.
Thursday, September 1, 2005
From the IT Director at Tulane... We appreciate the efforts of all of you to assist those of us at Tulane Law School as we put in place methods to communicate with one another. Our efforts will be helped immensely if all were to put links directing people to the "official" Tulane Law School website, which is being hosted and co-developed by our colleagues at Emory:
From the IT Director at Tulane...
We appreciate the efforts of all of you to assist those of us at Tulane Law School as we put in place methods to communicate with one another.
Our efforts will be helped immensely if all were to put links directing people to the "official" Tulane Law School website, which is being hosted and co-developed by our colleagues at Emory:http://tulane.law.emory.edu
This is the site which will be used by Dean Larry Ponoroff to officially communicate to our community and we are starting to achieve a critical mass of participation, with about 400 of our faculty, staff, and students checking in during the 24 hours this has been in existence. As you can imagine, things are changing very quickly for those of us from Tulane. Many of us are in transit between different evacuation sites and this is slowing communications. The evolution of this new site will help immensely just to get contact information for our administration so that we can begin the task of communicating with our students. We all feel a real sense of community evolving in the aftermath of Katrina and the generosity we are seeing both from our temporary hosts around the country and our "virtual" communities such as Teknoids really helps in the current situation.
This is the site which will be used by Dean Larry Ponoroff to officially communicate to our community and we are starting to achieve a critical mass of participation, with about 400 of our faculty, staff, and students checking in during the 24 hours this has been in existence.
As you can imagine, things are changing very quickly for those of us from Tulane. Many of us are in transit between different evacuation sites and this is slowing communications. The evolution of this new site will help immensely just to get contact information for our administration so that we can begin the task of communicating with our students.
We all feel a real sense of community evolving in the aftermath of Katrina and the generosity we are seeing both from our temporary hosts around the country and our "virtual" communities such as Teknoids really helps in the current situation.
Professor Douglas Mossman sends the following article which reports on the stalking of mental health professionals. The article is from The New Zealand Herald, which reports,
Mental health professionals are up to five times as likely to be stalked as the general population -- yet they are probably the least likely to seek help, researchers say. . . .
Studies in the United States show clinicians are the biggest target, with 36.9 per cent reporting they had been stalked, while around 11.9 per cent of students were affected, compared with 5 per cent of the general population .
Prof Hughes, leading the survey of health professionals through the Australia New Zealand College of Psychiatrists and the College of Mental Health Nurses, said those surveyed would be tested on their responses to different scenarios.
"Clinicians are of particular interest, not only because they may have been victims themselves, but because they are often required to treat perpetrators and victims," she said.
But because clinicians were used to dealing with "uncharacteristic behaviour" in their jobs on a daily basis, they tended to be more tolerant of potential stalkers.
"They often put up with things under the guise of saying 'These people are mentally ill and this is what they do', rather than seeing it for what it is, so they delay getting assistance from police and others."
Even when clinicians recognised a client's behaviour as stalking, it appeared they were reluctant to get help, as they felt they should be able to deal with it, or that it was "an expected part of their job", Prof Hughes said.
If you should wish to learn more about stalking, Professor Mossman, with his colleague Debra Pinals, M.D., and 8 other psychiatrists are currently finishing up a book about stalking and have thorough knowledge and expertise in the area. [bm]
From Professor Eric Muller:
I have set up blogs for the Loyola-New Orleans and Tulane Law School communities to use over the coming days and (if necessary) weeks and months. The idea is to give the communities a message board -- a place to post information of common interest that community members can access (as they are able). People can post to the blogs by emailing me at the below addresses, or by phoning me at (919) 962-7067 and leaving a message with the content of what they'd like posted.
URL = http://www.isthatlegal.org/tulanelaw
email (for posts) = email@example.com
For Loyola-New Orleans:
URL = http://www.isthatlegal.org/loyno
email (for posts) = firstname.lastname@example.org
The success of these blogs as information clearinghouses for these communities depends on GETTING THE WORD OUT. Most members of these communities are still without power, and will only slowly be regaining internet access. As I understand it, the university computer systems are entirely down.
Please pass the word along to others that these blogs exist, and that they are open to receiving posts about school-related matters from members of the affected communities. I am especially at a loss to know how to reach the affected student bodies, so if you can forward to someone who might be able to get the word out to them, please do so, or notify me and I'll contact them.
Professor Elizabeth Pendo also reports on other efforts to maintain communications:
You might already know about this, but the Clinical Law Prof Blog is serving as a place for people to communicate after Hurricane Katrina. A friend and one of the editors of the blog, Pamela Metzger at Tulane, set up a posting line for clinical faculty, students, staff and clients to post exchange information.
She also set up a blogspot for the Tulane and Loyola law school communities at http://metzgerlevittfamily.typepad.com/new_orleans_where_are_you/.
We hope that people find all their friends, colleagues and family safe.
Wednesday, August 31, 2005
The on-line Wall Street Journal's "Evening Wrap" reports (requires paid subscription) this afternoon that "Susan Wood, director of the Food and Drug Administration's Office of Women's Health, resigned in protest of the agency's delay in allowing over-the-counter sales of Barr's Plan B 'morning-after' pill. The FDA recently postponed indefinitely a decision about the emergency contraception, saying it wasn't sure it could keep the pill out of the hands of minors. Ms. Wood said the agency's decision ran counter to staff recommendations and suggested it could increase the number of unwanted pregnancies and abortions. Right-to-life groups object to the pill, calling it a form of abortion. FDA Commissioner Lester Crawford promised in recent Senate confirmation hearings that the agency would rule on the drug, which has been in limbo for two years, by Sept. 1. The agency's about-face has raised the ire of Democrats on Capitol Hill." Reuters has the story here. [tm]
As noted in today's edition of the CDC's Public Health News, Hurricane Katrina's aftermath poses huge challenges to public health authorities and legal authorities. Here is their summary of an article in today's N.Y. Times by Lawrence Altman and Kenneth Chang (“Disease and coordination vie as major challenges”):
The public health consequences of Hurricane Katrina are likely to be enormous and long term, according to CDC, the U.S. Department of Homeland Security, and other federal agencies. Of particular concern is the potential for outbreaks of disease spread by contaminated drinking water, spoiled food, and insects, officials said. Multiple deaths have already been attributed to drowning and carbon monoxide poisoning from the use of gas-powered generators in poorly-ventilated areas. Emergency personnel are working to evacuate the remaining residents before disease outbreaks and other public health problems take their toll. “We’re racing the clock,” said Homeland Security Secretary Michael Chertoff. The Department of Health and Human Services is working to send basic emergency medical supplies to the area, and to relocate patients stranded in flooded local hospitals. The U.S. Public Health Service deployed 38 doctors and nurses and has 217 more personnel on standby. Officials said rescue efforts would be complicated by broken glass, downed power lines, poisonous snakes, and raccoons, which can spread rabies and leptospirosis, a bacterial disease. Another concern involves residents who have lost access to needed prescription drugs and the potential for continued drug shortages at local pharmacies. “This is going to be a long-term event,” said CDC epidemiologist Dr. Thomas H. Sinks Jr.
Today's Washington Post on-line edition has a summary of federal agencies' responses to Hurricane Katrina as of 1:50 this afternoon:
- The Federal Emergency Management Agency, the nation's disaster-relief agency, has provided medical assistance, search and rescue and support teams, supplies and equipment to the hurricane area.
- The Coast Guard has rescued or assisted more than 1,250 people. It has recalled more than 500 reservists to help relief efforts and activated three national strike teams to help in removal of hazardous materials.
- The National Guard is providing support to civil authorities, providing generators, medical assistance and shelters and augmenting civilian law enforcement.
- The Defense Department has established Joint Task Force Katrina, based in Camp Shelby, Miss., to act as the military's on-scene command in support of FEMA. It will provide rescue teams and medical evacuation units, a hospital ship and disaster-response equipment.
- The Health and Human Services Department has sent hospital beds and public health officers. It is helping to coordinate hospitalization efforts and is providing medical supplies.
- Centers for Disease Control experts are working with Louisiana state officials to implement a mosquito-abatement program.
- The Transportation Department is helping with damage assessments and is supporting detour planning and critical transportation system repairs.
- The Agriculture Department is providing food and assisting in setting up logistics staging areas, the distribution of food products and debris removal.
- The Occupational Safety and Health Administration is providing technical assistance to recovery workers and utility employers engaged in power restoration. In addition, OSHA is contacting major power companies to the affected areas to provide safety briefings to employees at power-restoration staging areas and informing workers about hazards related to restoration and cleanup.
- The Internal Revenue Service has announced special relief for taxpayers in the disaster area.
- The Small Business Administration will position loan officers in federal and state disaster recovery centers.
- The American Red Cross is providing a safe haven for nearly 46,000 evacuees in more than 230 Red Cross shelters. It is also providing relief workers.
Meanwhile, state and local officials are sounding increasingly overwhelmed by the crisis. This is from an AP story posted this afternoon (courtesy of Yahoo! News):
The mayor said Wednesday that Hurricane Katrina probably killed thousands of people in New Orleans.
"We know there is a significant number of dead bodies in the water," and others dead in attics, Mayor Ray Nagin said. Asked how many, he said: "Minimum, hundreds. Most likely, thousands."
The frightening prediction came as Army engineers struggled to plug New Orleans' breached levees with giant sandbags and concrete barriers, while authorities drew up plans to move some 25,000 storm refugees out of the city to Houston in a huge bus convoy and all but abandon flooded-out New Orleans.
Gov. Kathleen Blanco said the situation was desperate and there was no choice but to clear out.
"The logistical problems are impossible and we have to evacuate people in shelters," the governor said. "It's becoming untenable. There's no power. It's getting more difficult to get food and water supplies in, just basic essentials."
A full day after the Big Easy thought it had escaped Katrina's full fury, two levees broke and spilled water into the streets Tuesday, swamping an estimated 80 percent of the bowl-shaped, below-sea-level city, inundating miles and miles of homes and rendering much of New Orleans uninhabitable for weeks or months.
"We are looking at 12 to 16 weeks before people can come in," Nagin said on ABC's "Good Morning America, "and the other issue that's concerning me is we have dead bodies in the water. At some point in time the dead bodies are going to start to create a serious disease issue."
How can the rest of us help? Here's FEMA's list of organizations seeking or accepting donations:
- American Red Cross 1-800-HELP NOW (435-7669), English, 1-800-257-7575, Spanish
- Operation Blessing 1-800-436-6348
- America’s Second Harvest 1-800-344-8070
- Adventist Community Services 1-800-381-7171
- Catholic Charities, USA 1-703-549-1390
- Christian Disaster Response 1-941-956-5183 or 1-941-551-9554
- Christian Reformed World Relief Committee 1-800-848-5818
- Church World Service 1-800-297-1516
- Convoy of Hope 1-417-823-8998
- Lutheran Disaster Response 1-800-638-3522
- Mennonite Disaster Service 1-717-859-2210
- Nazarene Disaster Response 1-888-256-5886
- Presbyterian Disaster Assistance 1-800-872-3283
- Salvation Army 1-800-SAL-ARMY (725-2769)
- Southern Baptist Convention Disaster Relief 1-800-462-8657, ext. 6440
- United Methodist Committee on Relief 1-800-554-8583
Other Groups Soliciting Donations
- Episcopal Relief and Development 1-800-334-7626, ext. 5129.
- Donations to many of these organizations can be made through Network For Good.
Matthew Holt of the HealthCareBlog reports on an interesting trend - Canadian doctors are returning to Canada. He makes some interesting points about what this might mean about the single-payer system and our current health care system. He states,
Well now we have more actual statistics and real data that shows that more Canadian doctors are heading back to Canada than are leaving -- and this was in 2004 when hockey was on strike so there was no real reason to go to Canada! The numbers are:
Canada has seen more doctors returning than leaving for the first time in 30 years, a report by the Canadian Institute for Health Information (CIHI) shows. The report, released Wednesday, says that between 2000 and 2004,the number of physicians leaving Canada declined by 38 percent. In 2004, 317 physicians returned to Canada and 262 left. That was a drop from 2000, when 420 doctors left the country and a significant decrease from the peak of 771 physicians who moved abroad in 1994.
I'm looking forward to the barrage of articles from the know-it all alleged "free-market" crowd who get spoon-fed rubbish by Frasier, PRI, Manhattan et al offering their apologies to the Canadians and admitting that their system is better than the one down here. After all the alleged rush of Canadian doctors to the US was absolute proof in their mind that the reverse was true.
Thanks to Ezra Klein for this website. Ezra also has some interesting comments on the data if you are interested. Just click on the link. [bm]
The Social Philosophy and Policy Center at Bowling Green State University will hold a conference entitled Liberalism: Old and New on September 15-18, 2005. Thirteen distinguished scholars from major universities around the country will present papers. The participant list includes:
- Sotirios A. Barber, Professor of Political Science, University of Notre Dame
- Eldon Eisenach, Professor of Political Science, University of Tulsa
- William A. Galston, Saul I. Stern Professor of Civic Engagement and Director, Institute for Philosophy and Public Policy, University of Maryland
- Gerald Gaus, Professor of Philosophy and Faculty Member of The Murphy Institute, Tulane University
Jacob Levy, Assistant Professor of Political Science, University of Chicago
- Loren Lomasky, Cory Professor of Political Philosophy, Policy and Law, and Director of the Political Philosophy, Policy and Law Program, University of Virginia
- Ronald J. Pestritto, Associate Professor of Politics, University of Dallas
- Debra Satz, Associate Professor of Philosophy, and Director, Ethics in Society, Stanford University
- David Lewis Schaefer, Professor of Political Science, College of the Holy Cross
- Ian Shapiro, William R. Kenan, Jr. Professor and Chairman, Political Science, Yale University
- Thomas A. Spragens, Jr., Professor of Political Science, Duke University
- Peter Vallentyne, FlorenceG. Kline Chair in Philosophy, University of Missouri-Columbus
- Michael P. Zuckert, Nancy Reeves Dreux Professor of Government, University of Notre Dame
The sessions are free and open to the public. No registration is required. (If you are planning to bring a group of any size, however, please let me know by email.) All sessions will be held in the Bowen-Thomson Student Union at Bowling Green State UniversityIf you would like more information about this conference or other SPPC events, please do not hesitate to contact Bowling Green State University at 419-372-2536. You can also learn more by visiting their website at www.bgsu.edu/offices/sppc.
Tuesday, August 30, 2005
As discussed by the Kaiser Family Foundation's "Daily Report":
The Washington Post on Monday examined the "near-record" number of laws passed by state legislatures this year that impose new restrictions on a woman's access to abortion or contraception. Grassroots antiabortion advocates are working to change the legal setting "one state at a time," while national leaders on both sides of the debate focus on the upcoming hearings of Supreme Court nominee Judge John Roberts, according to the Post. Abortion-rights opponents say they are using a two-pronged approach that aims to "reduce the number of abortions immediately through new restrictions and build a foundation of lower court cases designed to get the high court to eventually" reverse Roe v. Wade, the 1973 Supreme Court decision that struck down state abortion bans, the Post reports. David Bereit, director of program development for the American Life League, said, "People are becoming frustrated more progress hasn't been made at the federal level and feel they don't have as much control to change things here," adding, "If we can't outright ban abortion, what can we do to make it less prevalent? We see it's much easier to take up funding and parental notification measures at the state level." In many cases, antiabortion groups successfully pushed through bills to restrict "when and where women can get contraceptive services and abortions, and how physicians provide them," the Post reports. Other efforts enacted in some states include "trigger" laws that would immediately ban abortions if Roe were overturned; the provision of funds to encourage women to carry a pregnancy to full term with the possibility of adoption; and the addition of criminal charges for harming a fetus during the commission of a crime against a pregnant woman (Connolly, Washington Post, 8/29).
The Sentencing Law and Policy blog points out a recent AP news story from Texas concerning whether Texas doctors who perform "abortions without parental approval or after the third trimester could face capital murder charges because of a new law that takes effect this week." From the AP article, Like Texas, many states have enacted parental consent and fetal protection laws, said Jody Ruskamp-Hatz, policy specialist for the National Conference of State Legislatures. Ruskamp-Hatz said she is not aware of another state in which there is an interpretation that abortion doctors could be subjected to capital murder charges. The Texas Medical Association said it opposes any legislation with the stated purpose of subjecting doctors to capital murder charges. A violation of the parental consent law "would mean the physician could lose his or her license, not his or her liberty," spokesman Darren Whitehurst said. Thanks to the Sentencing Law and Policy blog for this cite. [bm]
The Sentencing Law and Policy blog points out a recent AP news story from Texas concerning whether Texas doctors who perform "abortions without parental approval or after the third trimester could face capital murder charges because of a new law that takes effect this week." From the AP article,
Like Texas, many states have enacted parental consent and fetal protection laws, said Jody Ruskamp-Hatz, policy specialist for the National Conference of State Legislatures. Ruskamp-Hatz said she is not aware of another state in which there is an interpretation that abortion doctors could be subjected to capital murder charges.
The Texas Medical Association said it opposes any legislation with the stated purpose of subjecting doctors to capital murder charges. A violation of the parental consent law "would mean the physician could lose his or her license, not his or her liberty," spokesman Darren Whitehurst said.
Thanks to the Sentencing Law and Policy blog for this cite. [bm]
Professor Douglas Mossman sends this message from the Bazelon Center for Mental Health Law. He says that if the Bazelon Center's depiction of the proposed legislation is accurate, passage of the bill would be a huge blow to outpatient mental health treatment for persons whose care depends on public sector funding. AT THE FEDERAL LEVEL: URGE CONGRESS TO REJECT RECENT MEDICAID PROPOSAL Bazelon Center for Mental Health Law - August 18, 2005 - The Bush Administration has just sent Congress proposed language to amend the definitions of Medicaid rehabilitation and targeted case management services, two core elements of public community mental health systems. The changes, if enacted, could make it impossible for states and localities to bill Medicaid for intensive community-based services for adults with serious mental illness and children with serious mental or emotional disorders. Congressional committees will consider these proposals from the Centers for Medicare and Medicaid Services (CMS) in September. Members of Congress need to hear from constituents about the catastrophic impact their enactment would have on an already struggling public community mental health system. Take Action Now by clicking on the following link:
Professor Douglas Mossman sends this message from the Bazelon Center for Mental Health Law. He says that if the Bazelon Center's depiction of the proposed legislation is accurate, passage of the bill would be a huge blow to outpatient mental health treatment for persons whose care depends on public sector funding.
AT THE FEDERAL LEVEL: URGE CONGRESS TO REJECT RECENT MEDICAID PROPOSAL
Bazelon Center for Mental Health Law - August 18, 2005 - The Bush Administration has just sent Congress proposed language to amend the definitions of Medicaid rehabilitation and targeted case management services, two core elements of public community mental health systems.
The changes, if enacted, could make it impossible for states and localities to bill Medicaid for intensive community-based services for adults with serious mental illness and children with serious mental or emotional disorders.
Congressional committees will consider these proposals from the Centers for Medicare and Medicaid Services (CMS) in September. Members of Congress need to hear from constituents about the catastrophic impact their enactment would have on an already struggling public community mental health system.
Take Action Now by clicking on the following link:
Monday, August 29, 2005
For those of you whose physicians are making you feel guilty about the pleasures of Starbucks and other purveyors of caffeinated elixir (that would be 7-Eleven in my case), there's this health news to make your day a little brighter:
"Americans get more of their antioxidants from coffee than any other dietary source. Nothing else comes close," says study leader Joe Vinson, Ph.D., a chemistry professor at the university. Although fruits and vegetables are generally promoted as good sources of antioxidants, the new finding is surprising because it represents the first time that coffee has been shown to be the primary source from which most Americans get their antioxidants, Vinson says. Both caffeinated and decaf versions appear to provide similar antioxidant levels, he adds.
. . . . The news follows a growing number of reports touting the potential health benefits of drinking coffee.
[tm, proud owner of a coffee mug from Starbuck's Store No. 1]
Law.com reports on a recent development in the world of physician peer review. The abuse of physician peer review to discourage doctors from testifying for plaintiffs in medical malpractice cases. The article states,
The Daily Business Review first reported increased peer review as a tactic to chill plaintiff-side testimony in 2003. Since that time, medical associations have stepped up their efforts to rein in experts, making it harder for plaintiffs attorneys to find physician witnesses and bring cases.
"In the last couple of years, doctors have been very reticent to speak with you, let alone take a case," said Deborah Gander, a partner at Coral Gables, Fla.-based Colson Hicks Eidson. "They don't even want to take the initial phone call. They say, 'I can't afford to get my name out there as a plaintiff expert.'"
Under Florida law, an expert opinion is required to file a medical malpractice case. South Florida plaintiffs attorneys fear that as a result of the pressure from medical groups the expert well is drying up, making it harder to file and litigate medical malpractice cases.
Last Friday, Lester Crawford, Commissioner of the Food and Drug Administration, delayed indefinitely a decision to make Plan B available over-the-counter. The Washington Post describes his reasons and the responses:
FDA Commissioner Lester M. Crawford acknowledged that the agency's drug review staff had concluded the drug could be safely used as an over-the-counter drug by women older than 17. But in an unexpected twist, Crawford also said the application raised complicated and unresolved issues about whether current regulations allow a drug to be legally sold by prescription only for teenagers but over the counter for all others.
"What we're saying today is that there are unique regulatory issues here that need to be addressed before we can take a final action on the application," Crawford said. He said he could not estimate how long that might take.
Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) said they were incensed because they had allowed Crawford's nomination as commissioner to move forward this summer only after getting a promise that a decision on the Plan B issue would be made by Thursday.
"I am stunned and outraged and furious," Murray said. "This is not only a broken promise to us, but another frightening example of politics trumping science at the FDA."
The New York Times further reported on the story and the influence that politics appears to be playing in this decision. It states,
"At some point, the statute requires that the agency make a decision," said Dr. Eve E. Slater, an assistant secretary of health from 2001 to 2003. "You can't just delay forever."
The Plan B decision has become "overly politicized, and it shouldn't be," Dr. Slater added. Under federal regulations, the Food and Drug Administration was required to reach a decision on Plan B by January. Nothing happened. Indeed, Barr executives said they had no discussions with the agency after January. Usually when the agency is actively considering an application, there is a constant back-and-forth with the company.
Today, Senator Clinton called for congressional hearings into the matter of the delay for Plan B's availability without prescription. [bm]
Sunday, August 28, 2005
The New Yorker has an interesting article by Malcolm Gladwell entitled, "The Moral-Hazard Myth: The Bad Idea Behind Our Failed Health-Care System." He writes,
The moral-hazard argument makes sense, however, only if we consume health care in the same way that we consume other consumer goods, and to economists like Nyman this assumption is plainly absurd. We go to the doctor grudgingly, only because we’re sick. “Moral hazard is overblown,” the Princeton economist Uwe Reinhardt says. “You always hear that the demand for health care is unlimited. This is just not true. People who are very well insured, who are very rich, do you see them check into the hospital because it’s free? Do people really like to go to the doctor? Do they check into the hospital instead of playing golf?”
For that matter, when you have to pay for your own health care, does your consumption really become more efficient? In the late nineteen-seventies, the rand Corporation did an extensive study on the question, randomly assigning families to health plans with co-payment levels at zero per cent, twenty-five per cent, fifty per cent, or ninety-five per cent, up to six thousand dollars. As you might expect, the more that people were asked to chip in for their health care the less care they used. The problem was that they cut back equally on both frivolous care and useful care. Poor people in the high-deductible group with hypertension, for instance, didn’t do nearly as good a job of controlling their blood pressure as those in other groups, resulting in a ten-per-cent increase in the likelihood of death. As a recent Commonwealth Fund study concluded, cost sharing is “a blunt instrument.” Of course it is: how should the average consumer be expected to know beforehand what care is frivolous and what care is useful? I just went to the dermatologist to get moles checked for skin cancer. If I had had to pay a hundred per cent, or even fifty per cent, of the cost of the visit, I might not have gone. Would that have been a wise decision? I have no idea. But if one of those moles really is cancerous, that simple, inexpensive visit could save the health-care system tens of thousands of dollars (not to mention saving me a great deal of heartbreak). The focus on moral hazard suggests that the changes we make in our behavior when we have insurance are nearly always wasteful. Yet, when it comes to health care, many of the things we do only because we have insurance—like getting our moles checked, or getting our teeth cleaned regularly, or getting a mammogram or engaging in other routine preventive care—are anything but wasteful and inefficient. In fact, they are behaviors that could end up saving the health-care system a good deal of money.
Matthew Holt at HealthCareBlog has more commentary on this topic. [bm]