HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Saturday, April 2, 2005

Illniois Pharmacists - Different Values

Recently, I had blogged on a story concerning pharmacists and the adoption of conscience clauses by many states.  The laws permit pharmacists to refuse to fill prescriptions that violate the pharmacists' personal values.  Today, the New York Times and other news outlets report that Illinois Governor Rod Blagojevich has adopted a different approach.  On Friday, he approved an emergency rule requiring pharmacies to fill birth control prescriptions after learning about a Chicago pharmacist who refused to fill such an order because of moral opposition to the drug.  The rule takes effect immediately.  It requires that if a pharmacist does not fill a patient's prescription because of a moral or religious objection, another pharmacist must be available to fill it without delay.  (Mmm - sounds like a great idea to me  . . . ).  According to Maura Kelly Lannan of the Associated Press, Governor Blagojevich stated, "Our regulation says that if a woman goes to a pharmacy with a prescription for birth control, the pharmacy or the pharmacist is not allowed to discriminate or to choose who he sells it to," Blagojevich said. "No delays. No hassles. No lectures."

The Governor's administration is working on a more permanent law to address this issue.  It is a shame that we need legislation to address the issue of women obtaining properly prescribed medicines but I am glad that the Illinois Governor has taken the stance that he has.  [bm]

April 2, 2005 | Permalink

NIH's Conflict of Interest Rule Strikes Again

This morning's Washington Post reports that the conflict-of-interest rules unveiled in February by the NIH has resulted in the early departure of a fourth high-ranking official (James F. Battey, chief of the National Institutes of Health's high-profile human-stem-cell program and director of that agency's deafness institute).  He manages a family trust that provides educational funds for his father's seven grandchildren, and the divestiture requirements of NIH's policy would be too costly for the family trust.  The new rules appear to be far-reaching:

Yesterday, in a memo e-mailed to employees, a group of senior agency scientists detailed a legal opinion they recently received that made clear just how broad the new rules are.

"Basically this means anything NIHers do outside -- whether getting paid for it or not, from singing in a jazz group to selling art or jewelry, from volunteering at charity organizations to membership in a school or community organization to developing their own small business completely unrelated to biomedical science -- requires prior NIH approval," the memo says. "We find this very disturbing. It is intrusive and scary. It suggests the NIH owns our lives away from work."

The backlash has moved beyond the agency's Bethesda campus. A renowned Duke University physician has postponed accepting a job running the National Institute of Environmental Health Sciences. Scientific organizations have protested to government officials, and biotech companies have complained about the loss of NIH scientists from advisory boards and consulting deals.

The NIH's new ethics rule, plus a summary and an FAQ, can be found here[tm]

April 2, 2005 | Permalink

Friday, April 1, 2005

ImClone, Waksal, Prison & Cancer Research

Our colleagues over at White Collar Crime Prof Blog raised an interesting question today.  Sam Waksal is seeking early release from prison (after serving slightly less than 2 years of a 7-year, 3-month sentence) so that he can continue his cancer research.  Ellen Podgor muses over the implications of a decision one way or the other. . . .  [tm]

April 1, 2005 | Permalink

Catholic View on End-of-Life Treatments

As news reports on the Pope's failing health filter in, individuals might want to listen to NPR's interesting and informative interview with Father John J. Paris, professor of bioethics at Boston College, about Catholic doctrine concerning the end of life. He discusses the church's position on end-of-life treatments as well as a 2004 statement by the Pope on administering food and water to patients.  This discussion concerned Terri Schiavo and the removal of her feeding tube.  [bm]   

April 1, 2005 | Permalink

Apologies

I wanted to apologize to the blog editor of Maternal and Child Health, one of my favorite blogs, for giving him a sex change in an earlier post.  I apologize for my incorrect assumption and I have corrected the reference.  It is embarrassing but always important to be reminded of a tendency to think that people who write on certain topics, or who I tend to agree with, are just like me in terms sex, age, ethnicity, experience and more.  Thanks for the terrific blog. [bm]

April 1, 2005 | Permalink

The Schiavo Case: Lessons Learned

My recent posts to the contrary nothwithstanding, there's more to health law than end-of-life (EOL) decision making about life-sustaining treatments (LSTs), advance care planning, and the saga of Terri Schiavo.  That hasn't stopped the discussion on these topics at the beginning of every class the past couple of weeks in my health law class, though, despite the fact that EOL and LST are on the syllabus in my bioethics class, not in health law.  If I need a justification, a case that has become a cultural icon is obviously on the students' minds (and mine),  and it offers a very revealing look at the family/provider/state triangle of relationships that are within the purview of a health law class.  Along the way we've covered a little Con Law, Fed Courts, Civ Pro, Family Law, and advance directives law.  And in 21 years of teaching all of these courses (off and on), this is the first time I've had a class discussion (via listserve) of  the Rooker-Feldman doctrine, which coincidentally was the subject of a 9-0 Supreme Court opinion the same day (Wednesday) it was relied on by Judge Birch in his concurring opinion in the en banc decision in Schiavo v. Schiavo.

All of this discussion focuses us now on questions like this: What did we learn from the Schiavo case? What does the lay public need to know about the underlying legal and ethical principles? If (as a majority of the citizenry appears to believe) Congress overstepped its bounds with S. 686, does Congress have a legitimate role to play in these issues? And what is likely to happen in Congress and in the state houses in response to the Schiavo case?

Two articles in today's New York Times pick up on these themes:

Once the federal courts started handing down one defeat after another for the Schindlers last week, one of my students asked what the next move might be for Congress.  "They could start impeaching the judges who aren't going along with Congress' game plan," was my semi-facetious reply.  It turns out I wasn't far off the mark:

The political battle over Terri Schiavo erupted anew on Thursday as conservatives portrayed her death as the result of an unaccountable judiciary and Representative Tom DeLay, the House majority leader, threatened retribution against the judges who refused to intercede in the case.

"The time will come for the men responsible for this to answer for their behavior, but not today," said Mr. DeLay, who was instrumental in pushing emergency legislation that gave the federal courts jurisdiction over Ms. Schiavo's care, only to see them decline to order her feeding tube restored. Saying that the courts "thumbed their nose at Congress and the president," Mr. DeLay, of Texas, suggested Congress was exploring responses and declined to rule out the possibility of Congressional impeachment of the judges involved.

Some days I hate being right.  [tm]

April 1, 2005 | Permalink

Thursday, March 31, 2005

Terri Schiavo Has Died

The Washington Post and others are reporting that Terri Schiavo died this morning in a Pinellas County hospice 13 days after removal of her gastrostomy tube.  Her death came the day after her parents' appeals were denied by the U.S. Court of Appeals for the 11th Circuit and the Supreme Court of the United States.  Although this brings the legal odyssey of the Schindler and Schiavo families to an end, the fallout from the most litigated right-to-die case in American history will undountedly linger.  In addition to the announced intention of Congress to consider legislation in this area (as evidenced by Section 9 of S. 686), states are reconsidering their laws on the subject, as well (as reported by the New York Times this morning).  [tm]

March 31, 2005 | Permalink

Wednesday, March 30, 2005

PAS Bill in Vermont Legislature

Today's N.Y. Times reports that a bill to legalize physician-assisted suicide is back before the Vermont legislature, having been reintroduced in February after having died there last year.  The bill is H. 168 ("An Act Relating to Death With Dignity").  Here are links to the bill-status page and the text of the bill as introduced[tm]

March 30, 2005 | Permalink

11th Circuit Grants Schindlers' Last-Minute Bid

Last night, the 11th Circuit Court of Appeals granted the request of the parents of Terri Schiavo to be allowed to file a motion for en banc reconsideration out of time.  The Schindlers are arguing that District Judge Whittemore's review of the Florida decisions should have included a substantive review of the evidence, not just a procedural review.  Granting the request for leave to file is a relatively modest step by the court and certainly no indication of any willingness to grant reconsideration en banc, but it does give the Schindlers one last chance to obtain the relief they've been denied by every state and federal court they've petitioned.  The AP story on this development (courtesy of the San Francisco Chronicle) indicates that has been no ruling from the appeals court on the Schindlers' request for an order to reinsert Terri's feeding tube while their request for en banc reconsideration is pending.  [tm]

March 30, 2005 | Permalink

Tuesday, March 29, 2005

Underinsured - A Growing Problem

The AMNews runs a story about an often forgotten group of individuals, the underinsured.  The story reports on the harm that results from extremely high deductibles which make it hard for individuals to pay their health bills.  The doctors discussing this issue are calling for legislation that will address the problem of inadequate insurance, much like the Health Insurance Portabilty and Accountability Act (HIPAA) addressed preexisting condition clauses.    [bm]

March 29, 2005 | Permalink

U.S. News Rankings

It is that time of year again.  The dreaded U.S. News and World Report rankings of law schools are due to be released this Friday.   An early release by Volokh Conspiracy blog of the top 100 schools is now available.

Thanks to Professor Paul Caron and TaxLawProf blog for the heads up.  [bm]

 

March 29, 2005 | Permalink

Monday, March 28, 2005

Brooklyn Law School Conference

Next week, April 5, 2005 from 4-6pm, Brooklyn Law School is co-sponsoring a timely conference entitled, "Contemporary Challenges in Bioethics:  An Interdisciplinary Discussion of End-of-Life Issues.  The brochure states:

This program will feature experts from a number of related dsciplines, including law, medicine, and health advocacy.  Together the participants will explore case studies that present some of the most challenging bioethics issues of the day, including "who decides when medical intervention should end?"  The goal of this interactive program is to expose students and professionals to an interdisclinary approach to these issues and to foster greater understanding and collaboration among the various disciplines.

Sounds like a terrific conference.  For more information and to RSVP, please click here. [bm]

March 28, 2005 | Permalink

Pharmacists' Rights?

Today, the Washinton Post has a story concerning the behavior of certain pharmacists that refuse to fill prescriptions for birth control and morning-after pills.  The pharmacists argue that dispensing the medications violates their personal moral or religious beliefs.  The Post story reports,

An increasing number of clashes are occurring in drugstores across the country. Pharmacists often risk dismissal or other disciplinary action to stand up for their beliefs, while shaken teenage girls and women desperately call their doctors, frequently late at night, after being turned away by sometimes-lecturing men and women in white coats.

"There are pharmacists who will only give birth control pills to a woman if she's married. There are pharmacists who mistakenly believe contraception is a form of abortion and refuse to prescribe it to anyone," said Adam Sonfield of the Alan Guttmacher Institute in New York, which tracks reproductive issues. "There are even cases of pharmacists holding prescriptions hostage, where they won't even transfer it to another pharmacy when time is of the essence."

I find this type of behavior very troubling for a number of reasons, only one of which is the fact that I have not heard of any pharmacist refusing to fill Viagra, Cialis or other such prescription drugs.  I wonder where this will end - the article discusses how a number of states are considering "conscience clause" laws that would protect pharmacists who refuse to fill prescriptions that violate their beliefs.   I suggest that perhaps we need legislation that requires a pharmacy to ensure that a pharmacist capable of filling all prescriptions always be on duty so as not to leave a patient without the medical care they require. [bm]

March 28, 2005 | Permalink

Congress Likely to Consider End-of-Life Legislation

Sheryl Gay Stolberg of The New York Times reports today that, in the aftermath of the whirwind of controversy surrounding end-of-life decisions on behalf of Terri Schiavo, members of Congress on both sides of the aisle think Congress should at least hold hearings and possibly even prescribe new rules on the subject.  There appears to be enough interest on the part of disability-rights and pro-life groups to prompt Congressional action of some kind.  Past congressional efforts in this area include the "Baby Doe rules," the Patient Self-Determination Act of 1990, and (perhaps inadvertently) EMTALA (used as a basis for the 4th Circuit's decision upholding a treatment order in a futility case involving an anencephalic infant (In re Baby K) (WestLaw; requires subscription).   [tm]

March 28, 2005 | Permalink

Sunday, March 27, 2005

FDA and Declaration of Helsinki

According to a recent story from Reuters, the Food and Drug Administration has proposed that international guidelines, specifically the Declaration of Helsinki, ethical standards that protect patients involved in clinical trials, should no longer be followed for overseas trials.  The Declaration of Helinski guarantees certain rights to patients who take part in a clinical trials, including rights to continued access to drugs at the end of any study, and limitations on the use of placebos in such trials.   The Reuters story states,

Currently, FDA rules require studies supporting a new drug application be carried out in line with the declaration or any local laws, whichever is more protective for patients. But proposals made last year would weaken this so that overseas studies not conducted under an application for an investigational new drug need no longer comply with the declaration. Instead, they would simply have to meet good clinical practices. Dr. Robert Temple, FDA's associate director for medical policy, said he felt the "ethical necessities" of a trial were "well-covered" by the good clinical practice standards.

The story is more complex than it originally appears.  The blog, Maternal and Child Health, provides a helpful and more in-depth overview of this story and notes that the FDA does not appear to have ever adopted the 2000 Declaration of Helsinki, which is apparently the version of the Declaration at issue.  He provides some analysis of why the FDA may feel that the more demanding standards of the 2000 Declaration would overly limit future research opportunities. [bm]

March 27, 2005 | Permalink