| Sun | Mon | Tue | Wed | Thu | Fri | Sat |
|---|---|---|---|---|---|---|
| 1 | 2 | 3 | ||||
| 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| 11 | 12 | 13 | 14 | 15 | 16 | 17 |
| 18 | 19 | 20 | 21 | 22 | 23 | 24 |
| 25 | 26 | 27 | 28 | 29 | 30 | 31 |
On animal cloning, the FDA has issued a report that concludes that meat and milk from cow, pig and goat clones and the offspring of any animal clones, are safe.
The FDA has produced a report titled: Animal Cloning: A Risk Assessment. (This document is 968 pages long and may take several minutes to download.)
More information can be found on the FDA cloning web site here.
Posted by Jon Lutz
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 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 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
The blog, Biolaw: Law and the Life Sciences, has an interesting post on a recent European Patent that includes a method of gender selecting for sperm. Biolaw points out that the patent not only applies to this method, but in addition also claims that cover sperm cells themselves and that nowhere are the claims limited to non-human mammals. The notion of human germline patents is controversial.
Read the whole post here.
Read the European Patent law claims here.
Posted by Jon Lutz
There have been examples of researchers violating ethical standards to enhance their own careers. However Kelly P. Bannister, an ethnobotanist at the University of Victoria went our of her way to protect the indigenous group she researched on their use of plants for food and medicine.
she withheld extracts of the plants from her graduate supervisor, who wanted to sell them to a pharmaceutical company. Then, when she finished her dissertation, she had it sealed for five years. She didn't want companies to profit from her published work, perhaps at the expense — or at least at the displeasure — of the Indian groups that had collaborated with her.
Ms. Bannister, 41, an adjunct professor of environmental studies, directs a research-and-policy center dedicated to environmental projects at Victoria. She is in demand for publishing on the ethics of research involving aboriginal peoples, and she sits on several university, national, and international committees working to reform research policies.
Her studies focus on making academic research, writ large, more equitable to the indigenous groups it often studies. She concentrates on intellectual property — the stories, songs, and traditions of aboriginal peoples, which have in the past often been exploited or published without the agreement of those who shared them with the researchers.
Read the entire article in the Chronicle of Higher Education (Sept. 1, 2006 issue): Digging into the Roots of Research Ethics: How a Canadian ethnobotanist became a champion of research that advances the lot of indigenous peoples
Posted by Jon Lutz
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
Two recently published books discuss the bioethics of food. Eating with Conscience: The Bioethics of Food
by Michael W. Fox. Fox discusses the inner workings of the national food industry, including the treatment of animals, the use of herbicides, the loss of topsoil, and more. The second book is The Omnivore's Dilemma: A Natural History of Four Meals by Michael Pollan. One of the most eye opening issues Pollan discusses is the issue of the prevalence of corn in the American diet. He points out that in a basic meal like a hamburger, fries and a soda: the steer are feed corn, the fries are cooked in corn oil and the soda is sweetened with corn syrup. He reports that in a 
45,000 item grocery store a third of the items contain corn. Pollan discusses the health and ethical impact of an agricultural corn monoculture.
Posted by Jon Lutz
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
Biotechnology Law and Regulation - The ASEAN Perspective by Sufian Jusoh and published by Cameron May surveys the law and regulations relating to biotechnology activities in the 10 member countries of ASEAN. Topics covered include biotechnology policies, access to genetic resources and benefit sharing, biosafety laws relating to food, protection of plant varieties, patent, pharmaceuticals, labeling, and religious laws and cloning. There is more information here on the Cameron May site and also here on the Amazon UK site.
Posted by Jon Lutz
