FSU College of Law Research Center Blog

journey through madness

Elyn Saks, a professor of law and psychiatry at the University of Southern California, has written a memoir titled: The Center Cannot Hold:  My Journey Through Madness.  Elyn Saks has suffered from schizophrenia since  she was a small child and her book provides a gripping account of her ordeal. Saks published articles focus on finding policy solutions for modern mental health related issues. 

Her book can be seen on Amazon.com.
A good article on her is published in the Yale Daily News.

Posted by Jon Lutz

 

Cloned Livestock Poised To Receive FDA Clearance

According to a Wall Street Journal online report the FDA is getting ready to declare that milk and meat from cloned animals is safe to eat.

Read the article here.

Posted by Jon Lutz

The Economics of Organ Donation

The March 23, 2007, issue of the Chronicle of Higher Education has several articles on proposed solutions to the shortage of donor organs for transplantation.  The use of "spare" kidneys from living donors has increased but is nowhere near meeting demand.  One possible barrier to more transplants from living donors is that the donor is not compensated and in fact bears the cost of any ongoing health problems from the surgery.  The idea of arranging for some time of payment has generated interest among economics and surgeons. 

Posted by Robin Gault

BIID

BIID or Body Integrity Identity Disorder is according to Wikipedia "the overwhelming desire to amputate one or more healthy limbs or other parts of the body." The Leiter Reports: A Group Blog has an interesting post on the philosophical and ethic issues involved in amputating healthy limbs.  It includes links to other sources including "Amputees by Choice: Body Integrity Identity Disorder and the Ethics of Amputation" in the Journal of Applied Philosophy. 

Posted by Jon Lutz

United States ex. rel. David Franklin vs. Parke-Davis

Pharmaceutical companies spend a lot of money promoting their drugs.  In 1996 an employee of Parke-Davis under the whistleblower laws filed a law suit against Parke-Davis claiming they were illegally promoting the drug Neurontin for off label uses.  The Drug Industry Document Archive has collected many of the documents related to this case.  From their site:

The Drug Industry Document Archive (DIDA) houses about 1000 documents drawn primarily from United States ex. rel.  David Franklin vs. Parke-Davis, Division of Warner-Lambert Company (now owned by Pfizer, Inc). The litigation concerned the marketing of Neurontin (gabapentin). (See About the Project for more details.) DIDA also contains documents on the marketing of Vioxx (rofecoxib) from the public records of the Minority Office of the Congressional Committee on Government Reform. The documents in this Archive focus primarily on the marketing of Neurontin (gabapentin) and Vioxx (rofecoxib), and include internal documents from Parke-Davis, Merck & Co. and correspondence with outside physicians and organizations, such as medical education and communications companies and advertising firms. Also included are regulatory and legal documents, court filings and depositions.

The archive can be searched here, browse the index here or document highlights can be seen here.

Warner-Lambert agreed to pay $430 million to resolve the case involving its subsidiary Parke-Davis.  Read the Department of Justice's release here.

Posted by Jon Lutz

 

Polyheme

Polyheme is a blood substitute.   It has been used in clinical trials with trauma patients.  While federal regulation requires the consent of subjects for clinical trials the regulation also allow a waiver of consent  in certain cases which includes times in which the patient may be incapacitated and unable to give consent.  The relevant rule is 21 CFR 50.24.  Polyheme can save lives, but some ethical concerns have been raised. Ambulances do not carry blood but some do carry polyheme which can be administered to a critically injured patient.  However in a recent study it was revealed that many of the subjects that received polyheme at the location of their accident continued to receive polyheme even after they got to the hospital where a blood transfusion was available.
Read more below, both from the American Journal of Bioethics:
An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme Trial-(Abstract Only)
Letter to the Editor: Emergency Research Consent Waiver - A Proper Way

Posted by Jon Lutz

Transhumanism

The philosopher Francis Fukuyama defines transhumanism as "to liberate the human race from its biological constraints."  The book Nano-Bio-Info-Cogno Innovations: Converging Technologies in Society explores the legal, ethical, political and social implications of these emerging technologies and their impact on the human condition.   You can read a review here from The Institute for Ethics and Emerging Technologies or from Amazon here.

Posted by Jon Lutz

Documents in the News - Kansas Teen Privacy Opinion

Judge J. Thomas Marten of the Federal District Court for the District of Kansas ruled yesterday (April 18, 2006) in a case that sought to prevent enforcement of Kansas Attorney General Phill Kline’s application of the state mandatory reporting statute, Kan. Stat. Ann. § 38-1522, through an Attorney General’s Opinion, to consensual underage sexual activity. The AG’s opinion required reporting of all consensual underage sexual activity as sexual abuse.  In its order, the court granted plaintiffs' request for a permanent injunction against enforcement of the interpretation, holding that "a plain reading of the statute vests mandatory reporters, such as health care providers, with discretion to determine when there is 'reason to suspect a child has been injured' as a result of sexual abuse."

Posted by Mary McCormick

Whistleblower Program Needs Improvement

Whistleblowers act in many cases as the publics first line of defense against wrongful conduct of public officials.  But a recent audit overseen by the Office of Financial Management for the State of Washington suggests that a lack of follow through and an inability to protect whistleblowers weakened the program.  Read the report here.

Posted by Jon Lutz

Striking a Balance: Drug Labeling and the FDA

Today's pharamaceutical warning labels contain little useful information for consumers; rather, they attempt to over-warn of every potential side effect so as to protect manufacturers from getting sued.  A new Food and Drug Administration labeling rule could provide better information to consumers and prevent hyperactive litagation.  An American Enterprise Institute for Public Policy Research publication.  Read the whole essay here.

Posted by Jon Lutz