HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Friday, May 25, 2007

FDA Approves new "No-Period" Contraceptive Pill

Earlier this week, the Food and Drug Administration (FDA) approved Lybrel, a pill that stops a woman from having her period indeflintely.  The New York Times reports,   

The first birth-control pill meant to put a stop to a woman’s monthly period indefinitely has won federal approval, the manufacturer said on Tuesday.  When taken daily, the pill, called Lybrel and made by Wyeth, can halt women’s menstrual periods indefinitely and prevent pregnancies.

It is the latest oral contraceptive approved by the Food and Drug Administration to depart from the 21-days-on, 7-days-off regimen that had been standard since birth-control pill sales began in the 1960s, and is the first made to put off periods altogether when taken without a break.

Wyeth, based in Madison, N.J., plans to start Lybrel sales in July. The company said it had not determined a price. The pill contains a low dose of two hormones already widely used in birth-control pills, ethinyl estradiol and levonorgestrel.

There has been some mixed responses to this approval, some responses appearing quite odd to me.  Here is one reaction by Ms. Unruh, president of the National Abstinence Clearinghouse, as well as some responses by other bloggers.  I must admit, my reaction was -- how safe is this new drug?  -- The same response that I would have for any drug approved by the current FDA.  I also wonder if insurance companies plan to cover Lybrel.

May 25, 2007 | Permalink | Comments (0) | TrackBack (0)

Thursday, May 24, 2007

Sicko

Michael Moore's new film, Sicko, which details the many problems with the American health care system is getting a lot of rave reviews.   Here is what Salon.com had to say about the film,

"Sicko" does not display Moore at his most cinematically inventive or imaginative. It presents a TV-documentary-style parade of episodes, characters and settings, bouncing from various American cities to Canada, Britain, France and Cuba (and yes, don't worry, we'll get to that). Moore plays a far smaller personal role in this film, appearing only occasionally in his comic-relief role as the clueless buffoon who can't seem to grasp that healthcare in all those other countries is free, or virtually so. When he's eating dinner with a group of Americans living in Paris who begin to list all the things they can have as free or nearly free entitlements -- not just healthcare but an emergency doctor who makes house calls; not just childcare but a part-time in-home nanny -- Moore puts his hands over his ears and begins singing "La la la la la." (If you have kids or any kind of chronic family health problems, your reactions might include weeping in despair, slitting your wrists or booking a one-way ticket.)

Still, there is no mistaking the passion and political intelligence at work in "Sicko." It's both a more finely calibrated film and one with more far-reaching consequences than any he's made before. Moore is trying to rouse Americans to action on an issue most of us agree about, at least superficially. You may know people who will still defend the Iraq war (although they're less and less eager to talk about it). But who do you know who will defend the current method of healthcare delivery, administered by insurance companies whose central task is to minimize cost and maximize shareholder return? Americans of many different political stripes would probably share Moore's conclusions at the press conference: "It's wrong and it's immoral. We have to take the profit motive out of healthcare. It's as simple as that."

I hope this film has a big impact (although I thought Moore's last film might influence the election so what do I know).   Here is the movie trailer.

May 24, 2007 | Permalink | Comments (0) | TrackBack (0)

Wednesday, May 23, 2007

Data-Mining, Privacy, and the Drug Companies

I hadn't been following closely this New Hampshire case, IMS Health Incorporated, et. al. v. Kelly Ayotte, Attorney General, New Hampshire, but was disappointed to learn its outcome.  The case involved a New Hampshire statute that "bars data-miners from using patients' prescription drug information to directly market pharmaceuticals to physicians—an industry practice called detailing."   The federal court found the statute unconstitutional.  Modern Healthcare Online reports New Hampshire's response to the decision:

"The state has a substantial interest in protecting the privacy of New Hampshire physicians, defending the sanctity of the doctor-patient relationship and reducing healthcare costs," said Attorney General Kelly Ayotte in a written statement Thursday. "Healthcare costs in the state of New Hampshire are skyrocketing. The Prescription Information Law protects the state's interests and the interests of New Hampshire's physicians and citizens, which strongly outweigh the pharmaceutical industry's interest in increased profits."

Here is a further update from Majikthise on that state's efforts to curb data-mining of prescription drug scripts by pharmaceutical companies.

Three weeks ago, a federal judge ruled that New Hampshire's ban on drug company data mining was unconstitutional.

As I learned when I worked in pharmaceutical advertising, the prescribing report is one of the most powerful tools in any rep's arsenals. Drug salesmen walk into doctors' offices knowing exactly how many prescriptions that doctor for which drugs. Often, doctors don't even realize that the rep has their complete prescribing stats. The reps use this information to strong-arm doctors into prescribing more of their medications. . . . .

Despite the legal setback, [the Washington Post reports that] opponents of the practice haven't given up the fight.

"We don't like the practice, and we want it to stop," said Jean Silver-Isenstadt, executive director of the National Physicians Alliance, a two-year-old group with 10,000 members, most of them young doctors in training. (Thakkar is on the group's board of directors.) "We think it's a contaminant to the doctor-patient relationship, and it's driving up costs."

The American Medical Association, a larger and far more established group, makes millions of dollars each year by helping data-mining companies link prescribing data to individual physicians. It does so by licensing access to the AMA Physician Masterfile, a database containing names, birth dates, educational background, specialties and addresses for more than 800,000 doctors.

May 23, 2007 | Permalink | Comments (0) | TrackBack (0)

Prisoners as Organ Donors

The National Law Journal has an interesting post responding to South Carolina's recent decision to encourage prison inmates to donate organs.   An earlier version of the program offered a reduced sentence as an extra incentive to donate.  Rev. Michal Orsi writes about the many ethical concerns raised by the program:

First, the National Organ Transplant Act (1984) makes it a federal crime to take or to offer valuable consideration for a transplant organ. Even without the prospect of a reduced sentence, prisoners may feel pressured to donate organs in the hopes of receiving other favors. In light of this, the proposed law may still violate federal law since it would make a body part an exchangeable commodity.

Second, ethicists have always agreed that organ donation must be freely given. This means that the donor must not be subject to any force, pressure or fear. Freedom may also be compromised because the intense hothouse culture that exists in prisons often commands conformity. Prison is not a pleasant place. Some inmates who would not ordinarily donate an organ may feel compelled to do so in order to convince a parole board of their rehabilitation.

Third, if this legislation includes live donors, it would also compromise the medical profession, whose first principle — "do no harm" — would be violated. Surgical procedures such as kidney transplant from a live donor could put a donor in physical jeopardy. The operation is risky, may have long-term consequences and may even cause death. In these cases, it would seemingly be a betrayal of a doctor's professional ethics to perform such a surgery. Needless to say, good medical ethics require that the benefit outweighs the risk. The present and future danger of live transplants would unduly risk the prisoner's health and, therefore, the proposed legislation would be substandard according to traditional medical ethics. The principle of "do no harm" is often discussed when determining the ethics of a physician being involved in prison executions by lethal injection. Most of those involved in the field of medical ethics consider this a violation of the Hippocratic Oath.

Fourth, for living donors, there are moral issues that violate the common law principle of totality. Totality forbids the mutilation of the human body that would compromise its anatomical or functional integrity. This means that any removal of a healthy body part or any decrease in bodily function caused to the donor would be deemed immoral. An exception has been made only if fraternal love is the motive for the donation. Therefore, with a donation from a living donor, common law has always presumed some kind of authentic connection between the donor and the recipient, usually kindred. An exchange between people unknown to each other imperils the concept for charity and human solidarity that have been traditionally recognized as the only clear moral grounds for the risks involved in the procedure and the violation of the principle of totality.

To put the ethical problems of the South Carolina proposal in high relief, it must be noted that even programs that require the donation of an organ to receive an organ or programs that propose offering a monetary award to donor families for donor funeral expenses are considered to be unethical. They do not conform to the federal law that is based on the common law principle that organ donation must be a totally free altruistic act.

May 23, 2007 | Permalink | Comments (0) | TrackBack (0)

Tuesday, May 22, 2007

Flu Stories

Here is some information about the new HHS Website/blog for collecting flu stories.  The weblink states,

Recognizing the need for people to take pandemic flu preparations more seriously, and recognizing that blogging is a powerful and effective two-way communications tool, Health and Human Services Secretary Mike Leavitt is hosting a Pandemic Flu Leadership Conference in Washington DC on June 13, to which I've been invited (based on work done at Flu Wiki and here). And as part of the effort to reach as many people as possible, a blog has been set up to discuss the conference's theme pre-and post-gathering.

The HHS Pandemic Flu Leadership Blog opens today for a five week run. You can access it at http://blog.pandemicflu.gov/ and read my first post today (other posters will contribute over the course of the five weeks). This week's theme is 'why we need to prep'. The five week theme is laid out at the web site.

While it won't get the traffic that this place does, think about what it represents... a government department is asking for feedback from the public on an issue that the public may have as much expertise on as the Feds, at least in some aspects of preparation. We can't keep the grid up in a natural disaster (something near and dear to bloggers everywhere), and can't coordinate responses between education departments and public health in the event of a flu pandemic (schools will need to close). That's the job of the federal government, and they need to supply the leadership to make this issue a priority at the state and local level. But we do know something about personal preparedness. So, if you have comments or questions about the blog summit, please stop by. Public health authorities are trying to reach as many segments of the population as they possibly can.

Thanks to DemFromCT for this link and information.

May 22, 2007 | Permalink | Comments (0) | TrackBack (0)

International Perspective on Obesity

Thanks to Ezra Klein for pointing out this fun graphic that illustrates the United States obesity issue. Click here.

May 22, 2007 | Permalink | Comments (0) | TrackBack (0)