by Arthur P. Gershman
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
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
"The Doctors Trial:
The Medical Case of the Subsequent Nuremberg Proceedings"
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
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
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."
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:
- The IRB must have at least five members.
- 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.
- 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.
- The IRB should include both men and women, as long as they aren't
chosen specifically for their gender.
- The members of the IRB must not be all of the same profession.
- The IRB must include at least one scientist and at least one
non-scientist. These terms are not defined in the regulations.
- 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
- IRB members may not vote on their own projects.
- 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.
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