Experimental Ethics

by Youssef Rizk, Esq.

While doing some reading online during the work day, I came across an article about a recently FDA approved experiment that would attempt to develop a treatment for autism using stem cells collected from the child’s umbilical cord blood (“cord blood”) at birth. Quickly summarized, the experiment intends to locate children with autism that do not exhibit any obvious genetic pre-disposition for the disease, such as a hereditary history.  The experiment also attempts to rule out people with head injuries or other trauma that may have caused autism.  The study intends to focus on children with autism that developed the disease from factors like the environment or exposure to infection (perhaps easier said than done when it comes to filtering out candidates, but that’s their problem to figure out).

What really interested me about the article was one particular paragraph that read:

“Using the child’s own cord blood will make the study safe and ethical – plus, the cells are younger and have not been exposed to environmental factors, like viruses or chemicals, which can alter the cell’s function and structure. By using the children’s own stem cells, their bodies cannot reject them.”

The article suggests that using the children’s cord blood to gather stem cells is ethically sound in light of how divisive stem cell research is in society. The objections are mainly against human embryonic stem cells and the research performed using them, which is an objection closely linked to the abortion debate (and I am conveniently going to steer clear of that debate). Objections, which prompted President Bush to limit embryonic research and which President Obama reversed during his presidency. Nonetheless, using one’s own cord blood for stem cell research arguably avoids any ethical issues. It is simply blood kept for the original host’s use at a later time and does not rely on stem cells from other sources.

Intentional or not (and I’m assuming intentional), this experiment is designed in a way that avoids the stem cell research controversy. The decision to use the cord blood of the patients themselves is an admittedly smart way of going about obtaining stem cells because that also ensures that the patient will not reject those cells. It also happens to avoid the ethical debate, thus rendering the experiment with less opposition (if any) and easier to approve by the FDA.

One could argue that true/pure science should not be at the mercy of public opinion and that an experiment should remain unbiased by such opinions. The idea that allowing public opinion into science, corrupts pure scientific research could in fact have some truth (see the old “Cigarettes are good for you” ads like this one: http://www.youtube.com/watch?v=gCMzjJjuxQI).  

Nonetheless, we don’t live in a world where scientists can do whatever they want. Politics are everywhere from the highest reaches of the government to the struggle between competing lab-mates working on similar experiments. Scientists that seek to excel have no choice, but to play society’s games in order to keep progressing in their fields. Scientists often need to be liked as well as distinguished, especially when much of the funding for scientific fields comes from non-scientific sources. David H. Guston of Rutgers University calls it the principal-agent theory.

I thought about political influence on science when I read about the FDA approved autism experiment. Did the scientists consider potential societal objections to their work in such a controversial field? Did that consideration have a factor in the design of their experiment and in seeking FDA approval? Taking into account the fact that the laws of a nation can severely limit or open up scientific research, a good scientist would seem to have to take political factors into considerations for not only experiments, but for grants, and reputation. A scientist that knows how to “play the game” may be the scientist that has the best chance of advancing science.

I find this type of balancing act fascinating because unless a scientist goes off into international waters and funds his/her own research, there is always an influence of public opinion weighing in on the advancement goals of science. Does that influence merely dictate what fields scientists pursue or does it in fact dictate the course of experiments as well? The brief point made in the article about the experiment with autism and stem cells seems to illustrate just one example of where science as well as law/politics meet to discuss ethics.


Patents On Nature

by Youssef Rizk, Esq.

     Most people are aware that having a patent on an invention, process, or business method is a powerful benefit granted by the government that creates an exclusive right of use to the inventor. Translation: “My idea, not yours! Hands off!”  What people often forget, however, is that in exchange for that right, the government insists that all of the details surrounding the patentable material are revealed to the public.  This requirement is an attempt to balance the individual’s right against the rights of the general public.  It encourages new invention, but promises that eventually those new inventions will become accessible to the public domain (often after 20 years).

     The requirements for obtaining a patent, which reflect the intent of the government to reward invention, but then to have the invention benefit the public interest are that:

1. The invention must be patentable (i.e. fall under the statutory definition of what is patentable

2. The invention must be new/novel (i.e. does not exist prior to the patent process);

3. The invention must be useful; (i.e. it needs to have a beneficial function);

4. The invention must be non-obvious (i.e. it should not be something that someone with a similar set of skills or background could come up with easily); and

5. The invention must be adequately described to the point that someone following the instructions could re-create the invention


     Two recent decisions by the U.S. Supreme Court have shaken things up in the scientific community.  First, there was the decision in the Mayo Collaborative Services, DBAMayo Medical Laboratories, Et al. v. Prometheus Laboratories, Inc. case where the court denied patents held by Prometheus.  The patents protected a testing “method” used to determine whether or not a person’s body had absorbed too little or too much thiopurine drugs (used to treat autoimmune diseases) by analyzing the metabolites in the blood after ingenstion.  The case concludes (and I am heavily summarizing the legaleze) that Prometheus could not patent a process that simply told doctors to check the levels and then compare those levels to a scale of what is considered too high or too low.  The court determined that there was nothing novel about performing tests that doctors already performed, especially because the metabolites are a naturally occurring phenomena in the human body that result from metabolizing thiopurine drugs (which the drugs themselves have been in existence long before the patent).  The process also did not instruct the doctors to do anything specific.  For example, the (loosely paraphrased) instruction: “Check the levels of the patient’s metabolites,” was not followed with a description of how to do so.  Instead it was left up to the doctor to determine the correct procedure for measuring the metabolites.  This alone does not transform Prometheus’ process into anything patentable because it relies on the doctor’s innate knowledge to check the blood levels and measure them properly.

     In the more recent case of Association for Molecular Pathology v. Myriad Genetics, No. 11-725, the U.S. Supreme Court did not deny the patents, but rather remanded the decision to the Appellate court for reconsideration in light of the Prometheus decision.  Many in the legal community view this sort of thing as essentially a message from the Supreme Court to the Appellate court implying that they change their decision.  Others feel that it may simply be that the Supreme Court needs more to go on after the Appellate Court includes Prometheus in its analysis.  Regardless, the decision has many in an uproar. 

     For starters, in the Myriad case, the issue mainly concerns actual physical materials that Myriad patented rather than a process like that in Prometheus.  Myriad’s patents are for genes found in human DNA that when examined for mutations can indicate whether or not a woman is at high risk for breast or ovarian cancer.  Some argue that the Appellate court need not consider the Prometheus case because it simply has to do with a process that was poorly defined whereas Myriad has patents on actual physical materials.  In opposition to that reasoning some argue that the Supreme Court intends the Appellate Court to analyze the decision not in terms of the patented subjects, but in terms of whether or not one can patent a natural phenomena.

     DNA is something that occurs in nature.  Patenting genes in DNA could be akin to patenting an organ found in a newly discovered insect or the liquid form of oxygen, which does not exist on Earth naturally, but is a form of a natural element.  Simply put, these physical things cannot belong to any one person because no person created them.  However, a unique process for using the new insect organ or creating liquid oxygen could be patentable (In Diamond v. Diehr, 450 U. S. 175, 185, the Supreme Court found that a mathematical formula itself was not patentable, but a unique process that used the formula was.).  What complicates the matter is that Myriad claims that the mutations when analyzed outside the body are a new and transformative creation different from what occurs naturally.  Further (and this is where Prometheus may apply more strongly), Myriad purports to have a process for determining whether or not the genes carry a mutation.  The question is whether Myriad’s process to “determine if there is a mutation” is specific enough or whether it is as general as that in Prometheus.

     Many bio companies consider these U.S. Supreme Court decisions detriments that create disincentives for companies or inventors to continue with their research when there is potentially no patent reward.  Others consider the decisions a win for the scientific community in general because restricting access to naturally occurring phenomena or obvious diagnostic testing would impede scientific progress more greatly.  The courts must consider striking a balance between the openness that benefits communal knowledge and the individual protections that reward ingenuity.  Until we see how the Appellate court further analyzes the Myriad case in light of the decision in Prometheus, we will have to wait to see how these decisions ultimately affect scientific research generally and specifically with bio companies in the long run.  

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Related Reading:

Gene Patenting: Ethical and Legal Issues