The Bayh Dole Act and the fate of research

While researching information for my Ethical and legal issues in Biomedical writing class on the Indian version of the American Bayh Dole Act, I came across a very interesting article which I would like to share with you.

The article can be found at: http://money.cnn.com/magazines/fortune/fortune_archive/2005/09/19/8272884/index.htm

The article makes for very interesting reading and touches on many different incidences and issues.

The article talks about how the Bayh Dole Act , which was passed in 1980 in the United States, wasn't looked upon as the savior of the fate of federally funded research in the United States. The Bayh Dole Act basically allowed grantee institutions conducting research with federal funds to patent and commercialize their inventions. Prior to the Bayh Dole Act federally funded inventions belonged to the government and a very few of these inventions ever reached the public.

With regards to the implementation of a version of the Bayh Dole Act in India, I have been asking myself many questions over and over again:

Will innovation be hampered if universities are allowed to patent, commercialize, and basically make money off of their inventions created with federal funds?

WIll it hamper basic scientific research?

Will it create a uncontrollable rat race amongst scientist in universities?

So many questions, but I haven't yet come to a conclusion in spite of weeks of research, questioning, pondering, and deliberation.

Moral Complicity

In searching the Internet for medical-oriented ethics organizations, I found the website for the American Academy of Medical Ethics (AAME). AAME's mission: "...to promote the interests of medical educators, medical practitioners and scientists, and to protect and promote the historic values that have provided the long-standing foundation for western medical care".

On AAME's website, I found the following article on moral complicity: http://cbhd.org/content/addressing-issues-moral-complicity-when-where-why-and-other-questions. The article poses many interesting questions that I'm not sure how to respond to. For example, should physicians take advantage of findings from research that they know was obtained under unethical conditions but will help their patients? The author, Robert Orr, MD defines moral complicity by using this example: Does person B (in this case the physician who uses the data) have any moral culpability by associating with the actions of person A (in this case the person who conducted the unethical research)?

Timing is important in determining moral complicity. If someone knows ahead of time that an unethical act is about to occur that they will later benefit from and they facilitate the unethical act in happening, they are morally complicit. Another factor in deciding if a situation is morally complicit is proximity. Orr discusses the example of someone who washes the windows of a medical office where abortions are performed. Wouldn't this person be less complicit than the doctor who actually performs the procedures? In all, Orr identifies 5 factors that should be examined to determine if a situation is morally complicit.

This article made me wonder how moral complicity coincides with, or differs from ethics? Are they the same?

Acres of Skin

In Acres of Skin (1998), Allen Hornblum discusses the experiments conducted on prisoners at Holmesburg Prison from the 1950's until the experiments ended in 1974. Unlike the subjects in the Tuskegee experiment, the prisoners were not exclusively African-American. Also unlike the Tuskegee trials, the Holmesburg Prison experiments did not focus on sexually transmitted diseases, but focused on dermatological experiments. Albert Kligman, MD was the dermatologist supervising the studies and shockingly likened the prisoners' skin to acres of fertile farmland. Prisoners were exposed to radioactive elements, hallucinogenics, and other toxins while Kligman tested various drugs, including what would become Retin A. For years after the experiments ended, prisoners still suffered from exposure to these chemicals.

In doing a Google search of Dr. Kligman, I found that he is on the faculty as Professor Emeritus at the University of Pennsylvania. He received his medical degree from Penn in 1947. "Contact sensitization" is listed as one his specialties, along with "cutaneous toxicology".

In interviews after the experiments at Holmesburg ceased, Dr. Kligman continued to defend his practices. In 2006, renewed interest in using prisoners for research resurfaced. Supporters proposed that the 1978 regulations forbidding the use of prisoners in clinical research be repealed but that the government add safety measures to prevent abuses. Dr. Kligman is quoted as saying that regulations that restricted prisoner use in clinical research "should have never been written in the first place" because of the gains that the research provided to the general population.

Where do we draw the line between achieving greater good and abusing individuals who are incarcerated, marginalized, or without representation?

Enrolling Ineligible Patients in Trials

I was not aware that physicians violate clinical trial enrollment criteria by allowing unsuitable patients to participate in trials.

In the 10/29/09 New York Times, Pauline Chen, MD writes about her ethical concerns that arose from wanting to enroll a very sick patient in a clinical trial. Dr. Chen explains that her patient, who was diagnosed with liver cancer and only had 3 months to live, just wanted to live long enough to see her first grandchild be born. Dr. Chen begins to think about enrolling the patient in a clinical trial for an experimental drug.

The article goes on to explain that many physicians are faced with this ethical decision: to maintain study enrollment criteria and protocol and therefore obtain information that can be generalized for all patients or to violate study rules by focusing on improving the health of one patient. If physicians do allow patients to be enrolled in clinical trials by not disclosing how sick the patient really is, not only are patients harmed, but the trials can be as well. In a survey of 700 physicians published in an bioethics journal, 90% responded that they are alright with violating trial enrollment criteria if a patient could benefit from the trial. Also surprising is that more than 60% of physicians said that they would break study rules to help a patient.

Findings indicate that the value of the relationship between the patient and physician is still high; physicians are willing to violate medical ethics to retain the patient-physician bond and help patients live longer, even if they may ultimately die from an uncured illness. Dr. Chen's patient was provided with the study drug without enrolling in the trial and she lived long enough to become a grandmother, dying a few days later.

This article and study further call into question clinical study results and medical ethics. Link to article: http://www.nytimes.com/2009/10/29/health/29chen.html