HealthLawProf Blog

Plan B Fallout at the FDA

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]

Legal and Public Health Response to Katrina

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
• The Louisiana Society for the Prevention of Cruelty to Animals
• National Voluntary Organizations Active in Disaster
• Episcopal Relief and Development 1-800-334-7626, ext. 5129.
• Donations to many of these organizations can be made through Network For Good.

[tm]

Canadian Doctors Leave U.S.

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]

Liberalism Conference

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.

[bm]

'Near Record' Number of New State Abortion Laws

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).

[tm]

Death Penalty for Abortion Doctors?

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]

Bazelon Center Alert on Medicaid

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:

http://www.bazelon.org/takeaction/2005/8-18-05medicaid.htm 

[bm]

Tall Nonfat Latte with a Double Shot of Antioxidants

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]

Chills from Peer Review

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.

[bm]

Hurricane Katrina

Sending all positive thoughts to those who live in the New Orleans and coastal areas of Louisiana and Mississippi.  Stay safe!

For those of you interested in helping out:  the Red Cross website is available here or you can call them at 1-800-HELP NOW.

Plan B Delayed

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]

Moral Hazard Myth

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]

Doctors vs. Managed Care

Law.com provides an overview of doctor RICO suits currently filed against managed care companies.  It should be interesting to see if this type of suit gains popularity.  According to the article,

Ear, nose and throat doctor Michael Abidin was frustrated. Once again, an insurance company had stiffed him on a claim. Weeks before, the Alexandria, Va., physician had examined a female patient complaining of a hoarse throat. Abidin reviewed her family medical history looking for relatives with throat cancer. Then he slowly threaded a scope through her nose and down her throat for an examination.

Afterward, his office submitted a $205 claim to United Health Care Group Inc. to cover his evaluation and the laryngoscopy. United chose only to pay for the laryngoscopy, which cost $122.69.

The doctor was accustomed to this treatment. During the early months of 2000, Abidin says, insurers had refused to pay for exams before procedures 15 times, maybe more -- he was losing count. Why were insurers rejecting claims for standard medical practices and procedures?

At about the same time, in Birmingham, Joe Whatley Jr. believed he had solved the mystery, which was not limited to Abidin's experience. In his view, insurers were routinely denying claims in order to improve their financial performance. Since 1990, he estimated, managed care companies had saved at least $10 billion by shortchanging doctors. So, with fellow Birmingham lawyer Archie Lamb Jr. and Decatur, Ala., lawyer Nicholas Roth, among others, he filed a class action on behalf of 950,000 physicians, including Abidin.

The insurers, according to the suit, swindled the doctors by systematically and fraudulently cutting their bills. Health plans rely on software to process hundreds of millions of claims a year. Each claim carries some combination of 8,000 five-digit codes to describe individual procedures. Ten leading managed care companies, the lawsuit says, rigged this software to automatically ignore some codes and change others to reflect less costly procedures. They then counted on doctors' offices being too overwhelmed or perplexed to appeal. (Not so Abidin. The doctor did appeal -- twice -- before United Health paid him for the throat exam.)

The insurers insist that they properly handled the vast majority of claims. They say that when they make changes in claims, it is generally because the form was filled out incorrectly or because doctors are padding their bills. In a survey reported in the Journal of the American Medical Association in 2000, 39 percent of physicians admitted that they exaggerated the severity of patients' conditions, made up symptoms or altered diagnoses on claims. Insurers have invested hundreds of millions of dollars in automation to catch these problems, says Jeffrey Klein of New York's Weil, Gotshal & Manges, a spokesman for the defendants in the case. "The industry's reimbursement speed rivals or exceeds the vendor payments of virtually any other industry," Klein says.

[bm]

Duty to Aid

As all of us know from our torts classes, an individual does not have a duty to aid another in most instances.  Recently, however, in Sklarksy v. New Hope Gild Center, 12923/01, a court held that an exception to that rule exists, finding that husband had a duty to provide medical assistance to his wife, whose mental illness left her in a "diminished, incapacitated and helpless state."  According to law.com,

Plaintiff Alexander Skylarsky, a public-library janitor, initiated a psychiatric-malpractice claim against New Hope Guild Center for Emotionally Disturbed Children and three of its physicians. He alleged among other things that on the evening preceding Sofia Skylarsky's death, he called Dr. Marina Galea and told her that his wife was "running around frantically and speaking nonsense," and that he had found a suicide note. Dr. Galea declined to meet with Ms. Skylarsky because she did not have a scheduled appointment, Mr. Skylarsky testified.

The defense counterclaimed, contending that Mr. Skylarsky was negligent for failing to provide medical aid to his wife by refusing either to call emergency medical services or to take her to an emergency room as instructed by the defendant doctors.

On the night of June 5, 2000, after three days of rapid deterioration in his wife's mental state, Mr. Skylarsky decided he would take her to the hospital the following morning, he said. However, Ms. Skylarsky apparently jumped to her death in the middle of the night.

At issue in the present motion was whether Mr. Skylarsky neglected a legal duty to come to his wife's aid. . . .


Last week, a jury found in favor of the defense and dismissed Mr. Skylarsky's action. Nonetheless, under the terms of a "high-low" agreement, Mr. Skylarsky received a settlement totaling $325,000.

Though the jury did not award any damages, it found Mr. Skylarsky 30 percent liable for his wife's death. Had there been an award, Mr. Skylarsky would have had to pay himself (as administrator of his wife's estate).

The judge's decision will not be appealed, as both sides stipulated in the high-low agreement to forego any appeals. "If it would have been appealed, it wouldn't have been upheld. It would have opened up a whole new area of litigation," said Mr. Skylarsky's attorney, Eliot Wolf of Long Island-based Wolf & Fuhrman.

[bm]

Drug Companies and Fraud

If the Merck Vioxx case where not sufficient to have drug companies worried, the New York Times reports today that California has sued 39 drug companies for price gouging. 

The attorney general of California sued 39 drug companies on Thursday, accusing them of bilking the state of hundreds of millions of dollars by overcharging for medicines.

Attorney General Bill Lockyer charged that the drug makers, including some of the world's leading pharmaceutical concerns, defrauded the state's Medi-Cal system for at least the past decade. Mr. Lockyer said the drug manufacturers charged Medi-Cal as much as 10 times the price for some drugs as they charged others, like private pharmacies and hospitals.

Medi-Cal is the state's version of the federal Medicaid program for the poor, which is jointly financed by the states and the federal government. Drug costs account for about $4 billion of Medi-Cal's $34 billion annual budget.

"We're dragging these drug companies into the court of law because they're gouging the public on basic life necessities," Mr. Lockyer said at a news conference here. "This scheme has cost California taxpayers potentially hundreds of millions of dollars and is jeopardizing the public health by diverting money away from patient care."

Mr. Lockyer said that each of the companies made as much as $40 million a year in illegal profits. He said he hoped to recover that amount plus the triple damages allowed under the state's false claims act.

Thursday's legal filing amends a 2003 suit against two drug companies, Abbott Laboratories and Wyeth Pharmaceuticals, to add about three dozen new defendants, including Amgen, Baxter Healthcare, Bristol-Myers Squibb, GlaxoSmithKline, Mylan Laboratories, Novartis and Schering-Plough. It was immediately consolidated in federal court in Boston with similar litigation filed by more than 10 other states and localities, including New York, Texas, Florida and Illinois.

[bm]

Reality TV Meets Sperm Donors

In case you thought that reality television could not get any more bizarre or troubling - along comes a new potential series.  This new series is to be entitled, "I want your baby . . . and nothing else!" and in case you hadn't guessed concerns  a woman looking for a potential sperm donor to help her concieve a child.  Sounds lovely!  According to Reuters, the producer who bought you such delightful tv viewing as "Big Brother" will broadcast a preview this weekend to see if there is an audience for such a show.  Reuter reports,

"The plan is that we visit potential donors and -- of course on camera -- decide which man is most suitable," the 30-year old woman who will feature in the program said in an interview with De Telegraaf newspaper.

"Afterwards there will be artificial insemination," said the woman who was identified only as "Yessica" and who has bought a house with a room for a child.

Unfortunately, it appears that the preview show will be available in Europe and not here in the United States (at least not immediately).  I hope that you are not all too disappointed.  [bm]

Third Year of Law School

Students have complained for some time that the third year of law school is unnecessary and that they are ready to go out and practice after two years.  Well, someone heard them.  The University of Dayton is offering a two-year law degree.  I am not sure if this will catch on but I thought some of you would find it of interest.  From the University's Press Release,

Julius Carter enrolled at the University of Dayton's School of Law this fall because ''it offered a way for me to become a lawyer quicker."

The 42-year-old former computer analyst is part of the first class at the School of Law with the option to graduate in five semesters, instead of the traditional six. The University of Dayton is the first in the country to take advantage of new American Bar Association rules that allow students who start classes in the summer to finish their law degrees in two years.

The accelerated curriculum has attracted national media attention and helped to trigger the highest application volume in a dozen years and the best entering test scores since 1994. The School of Law received 2,116 applications--a 13.7 percent surge over last year. Nationally, law school applications are down 1.4 percent, according to the Law School Admission Council.

''The five-semester option was a big draw,'' said Carter, father of four from Trotwood, Ohio.

Lisa Kloppenberg, dean of the School of Law, says the revamped curriculum is targeted to mid-level professionals like Carter and ''the millennial generation that likes to multi-task and move quickly. These highly motivated students want to graduate earlier and begin earning faster. They can save a year of living expenses while completing the same law school curriculum requirements.

''We think other law schools will soon follow suit and give students the opportunity to eliminate the third year of law school," said Kloppenberg, who's been interviewed by the Associated Press, CNN Radio, National Public Radio, Bloomberg, Fox News and the nation's legal press, among other media outlets.

[bm]

Obesity Data from Public Health Organization

The Trust for American's Health released information on our increasingly obese nation yesterday, concluding that nearly 25% of the population is obese.  The group also provides data concerning which states have more problems with obesitiy than others based on data from the Centers for Disease Control and Prevention.  The New York Times reports on the group's latest findings and states,

Mississippi is the nation's most overweight state, Colorado is the least, and the Southeastern states generally have more heft than the rest of the country, according to a report released yesterday by a public health advocacy group. Obesity rates have continued to rise steadily across the nation, with the lone exception of Oregon, where they remained steady, the report by the group, the Trust for America's Health, said.

State and federal policies have done little to change that trend, the report said.

About 24.5 percent of American adults are obese, the report said, and in 12 states more than a quarter of all adults are obese, Mississippi, Alabama, West Virginia, Louisiana, Tennessee, Arkansas, Texas, Michigan, Kentucky, Indiana, Ohio and South Carolina.

The states with the smallest percentage of obese adults are Colorado, Massachusetts, Rhode Island, Connecticut, Vermont and Montana. (One state, Hawaii, was not ranked.)

The rankings are based on public data from 2004 released earlier this year by the federal Centers for Disease Control and Prevention. The information comes from telephone surveys by state health departments asking residents about health-related behavior like smoking, alcohol consumption and weight.

[bm]

Fetus and Pain Sensation

Just in time for the return of Congress and its interest in a federal law concerning information that women must be told about the fetus and feeling pain (not to mention the Supreme Court's Fall term, which includes two abortion cases) scientists have released a study showing that the fetus before 29 weeks cannot feel pain. The New York Times reports on the study, which has been released in the Journal of the American Medical Assocation.  The Times reports,

Taking on one of the most highly charged questions in the abortion debate, a team of doctors has concluded that fetuses probably cannot feel pain in the first six months of gestation and therefore do not need anesthesia during abortions.

Their report, being published today in The Journal of the American Medical Association, is based on a review of several hundred scientific papers, and it says that nerve connections in the brain are unlikely to have developed enough for the fetus to feel pain before 29 weeks.

The finding poses a direct challenge to proposed federal and state laws that would compel doctors to tell women having abortions at 20 weeks or later that their fetuses can feel pain and to offer them anesthesia specifically for the fetus.

About 1.3 million abortions a year are performed in the United States, 1.4 percent of them at 21 weeks or later.

Bills requiring that women be warned about fetal pain have been introduced in the House and Senate and in 19 states, and recently passed in Georgia, Arkansas and Minnesota. The bills are supported by many anti-abortion groups. But advocates for abortion rights say the real purpose of the measures is to discourage women from seeking abortions. It is too soon to tell what effect the new laws are having in abortion clinics.

The finding was considered persuasive by many scientists but is unlikely to settle the controversy. Most scientists agree that fetuses probably do not feel pain in the first trimester, but there remains wide disagreement over when, in later pregnancy, the fetal brain is sufficiently developed for pain to register. Some think that, with the current state of knowledge, it is impossible to know for sure. In Britain, the Royal College of Obstetricians and Gynecologists has said that fetuses probably do not feel pain before 26 weeks, which is into the third trimester.

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New Regulations on ACNE Medication

Thanks to Dr. Douglas Mossmass for this excellent post:

Isotreninoin (brand name Accutane^TM) is an oral medication used for treating severe acne that does not respond to any other acne treatments, including antibiotics. Because of an extremely high risk of birth defects, women users of isotreninoin have for years been required to have two negative pregnancy tests and to commit themselves to using two simultaneous forms of birth control before starting to take the medication. Prescribers have had to participate in the "System to Manage Accutane Related Teratogenicity (S.M.A.R.T.^TM). This program includes reading a booklet, signing a letter of understanding concerning the practitioner’s ability to diagnose acne and address risks associated with pregnancy, and affixing a yellow sticker to each prescription.

In addition to pregnancy-associated risks, isotretinoin may cause depression, psychosis, or suicidal ideation. The Food and Drug Administration (FDA) has been assessing reports of suicide or suicide attempts associated with use of this drug, and has recommended that all patients receiving isotretinoin be observed closely for symptoms of depression or suicidal thoughts.

On August 12, the FDA notified healthcare professionals and patients about a strengthened risk management program for isotretinoin called "iPLEDGE." iPLEDGE will require registration of wholesalers, prescribers, pharmacies and patients who agree to accept specific responsibilities for minimizing pregnancy exposures if they wish to distribute, prescribe, dispense, or use isotretinoin. The FDA also has approved changes to the existing warnings, patient information, and informed consent documentation so that patients and prescribers can better identify and address potential psychiatric problems before and after prescribing isotretinoin. The new patient information sheet appears here:

http://www.fda.gov/cder/drug/InfoSheets/patient/IsotretinoinPT.htm

August 22 was the first date on which doctors, patients, and pharmacies could obtain information and register with iPLEDGE via the internet, at https://www.ipledgeprogram.com.

After October 31, 2005, wholesalers and pharmacies will have to register with iPLEDGE to obtain isotretinoin from a manufacturer.

Starting December 31, 2005, all patients must be registered and activated by their doctors in iPLEDGE to get isotretinoin. Only prescriptions from iPLEDGE doctors will be filled by iPLEDGE pharmacies. Patients must sign the Patient Information/ Informed Consent form and must adhere to all the instructions in the iPLEDGE program. For women who can become pregnant, this includes using two effective birth control methods simultaneously and entering these methods of birth control each month into the iPLEDGE system by telephone or the internet. Women will also need to have negative pregnancy tests before each isotretinoin refill.

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