by Arthur P. Gershman
Rn 27,035

I. Background

   In "Questions and Reform Jewish Answers: New American Reform Response" by Walter Jacob, the topic of Patenting Genetic Engineering was considered. A panel of Rabbis "felt a high degree of discomfort with patenting changes in a living creature." The rabbis reasoned:

"Social policy has led to plant patents. This has protected the livelihood of individuals and made a more abundant human existence possible. However patenting an animal leads us in a direction not conducive to respect for life. The holocaust has made us aware of the danger of dehumanization..."

The present author has written extensively in this publication on the topic of the ethics of patents on genetic material. More recently, he has written about AMP v. Myriad, currently pending before the CAFC, which has raised questions about the validity of these patents.

II. The Nazi Doctors

It may come as a revelation to some, but a number of German physicians actively participated in the Holocaust. As noted in the US Holocaust Memorial Museum:
"The Doctors Trial:
The Medical Case of the Subsequent Nuremberg Proceedings"
Holocaust Encyclopedia,
accessed on October 1, 2010:

"On December 9, 1946, an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity. Brigadier General Telford Taylor was Chief of Counsel, during the Doctors Trial. In Taylor's own words, from the opening statement by the prosecution,

'The defendants in this case are charged with murders, tortures, and other atrocities committed in the name of medical science. The victims of these crimes are numbered in the hundreds of thousands. A handful only are still alive; a few of the survivors will appear in this courtroom. But most of these miserable victims were slaughtered outright or died in the course of the tortures to which they were subjected. For the most part they are nameless dead. To their murderers, these wretched people were not individuals at all. They came in wholesale lots and were treated worse than animals.'

In Nazi Germany, German physicians planned and enacted the 'Euthanasia' Program, the systematic killing of those they deemed 'unworthy of life.' The victims included the institutionalized mentally ill and physically impaired. Further, during World War II, German physicians conducted pseudoscientific medical experiments utilizing thousands of concentration camp prisoners without their consent. Most died or were permanently impaired as a result. Jews, Poles, Russians, and Roma (Gypsies) were the most common victims of experimentation.

After almost 140 days of proceedings, including the testimony of 85 witnesses and the submission of almost 1,500 documents, the American judges pronounced their verdict on August 20, 1947. Sixteen of the doctors were found guilty. Seven were sentenced to death. They were executed on June 2, 1948."

Not tried was the infamous Josef Mengele, an SS physician, known for his inhumane medical experimentation on concentration camp prisoners at Auschwitz. In 1937 Mengele joined the Nazi Party. The following year, the same year in which he received his medical degree, he joined the SS. Mengele was transfered to Auschwitz, on May 30, 1943.

At Auschwitz Mengele performed a broad range of agonizing and often lethal experiments with Jewish and Roma ("Gypsy") twins, most of them children.

Many of his "test subjects" died as a result of the experimentation or were murdered in order to facilitate post-mortem examination.

Mengele had hoped to use the research he had garnered in Auschwitz in order to produce his Habilitation, a second, post-doctoral, dissertation required for admission to a university faculty as a professor in German-speaking lands.

US Holocaust Memorial Museum. "Joseph Mengele" Holocaust Encyclopedia. Accessed on October 1, 2010.

III. The AMA Position on Gene Patents

The position of the American Medical Association on patenting human genes, Opinion 2.105, may be found on the AMA web site here.

Carefully parsing the opinion, we are left with a void as to the question of whether patenting human gene sequences is considered ethical or unethical. Patenting processes such as isolating and purifying gene sequences, genes and proteins "do not raise the same ethical problems as patents on the substances themselves, and are thus preferable" [emphasis supplied]. This position roughly tracks with that of the rabbis, who have no ethical problem with patenting processes.

However, the AMA position goes on to state: "Substantive patents on purified proteins present fewer ethical problems [emphasis supplied] than patents on genes or DNA sequences and are thus preferable."

Is this another case of blind ambition obscuring physicians' concern for humanity?

IV. The Independent Ethics Committee

An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB), is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. In the US the FDA and DHSS (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.

IRBs were developed in direct response to research abuses earlier in the twentieth century. Among the most notorious of these abuses were the experiments of Nazi physicians that became a focus of the post-World War II Nazi Doctors Trial.

Examining the nuts and bolts of the IRB:

1. The IRB must have at least five members.
2. The members must have enough experience, expertise, and diversity to make an informed decision on whether the research is ethical, informed consent is sufficient, and appropriate safeguards have been put in place.
3. If the IRB works with studies that include vulnerable populations, the IRB should have members who are familiar with these groups. It is common for an IRB to include an advocate for prisoners when considering research that involves them.
4. The IRB should include both men and women, as long as they aren't chosen specifically for their gender.
5. The members of the IRB must not be all of the same profession.
6. The IRB must include at least one scientist and at least one non-scientist. These terms are not defined in the regulations.
7. The IRB must include at least one person who is not affiliated with the institution or in the immediate family of a person affiliated with the institution. These are commonly called "Community Members."
8. IRB members may not vote on their own projects.
9. The IRB may include consultants in their discussions to meet requirements for expertise or diversity, but only actual IRB members may vote.

In order to vote on a proposal, more than half of the members of the board must be present and there must be a non-scientist present. There are exceptions for expedited review, where only the chair of the committee or a designee reviews research, but these are relatively narrow. 45 CFR (Code of Federal Regulations) Part 46, 56 - $quot;INSTITUTIONAL REVIEW BOARDS". Food and Drug Administration (United States). 28 June 1991. Retrieved May 12, 2009. A similar policy is also codified for the Commerce Department at 15CFR27.

V. Conclusion

It is suggested that an IEC mechanism be codified to vet patents on human genes, similar to, but not identical with the IRBs used to vet human experimentation.