May 23 2016

Who Owns Your Genetic information?

genetic codeA genetic testing company, Myriad, is embroiled in a controversy over who owns genetic information. The company performs genetic testing, such as for BRCA1 and BRCA2 genes with variants that are associated with higher risk of breast cancer.

It has been the company’s policy to release information to their clients on any pathological gene variants, those known or suspected of being associated with higher breast cancer risk. If, however, the client has what is currently believed to be a benign variant, that is all they are told. They aren’t given the specific information about the gene sequence, just a note that it is benign.

Further, the company has declined to share its vast database of information with open source databases being used for research. The company cited patient privacy as their reason for not sharing data.

Now, several clients have sued Myriad to have their full genetic information released to them. It turns out a new rule under HIPPA (the Health Insurance Portability and Accountability Act) requires that companies release full genetic information to patients. Faced with this the company has decided to release the information to those who request it, but insist that it is voluntary and will still not release such information routinely (only to individuals who request it).

The reason people care about this is research. Gene variants that are currently believed to be benign may alter cancer risk, and one way to find out is by examining large numbers of patients and their genetics. Some of the patients who request their information did so specifically to turn that information over to researchers. Their argument is that they wish their genetic information to be available for research, and since it is their genes they should get to decide what happens with that information.

I am not sure why Myriad does not want to share their data more readily. I understand the privacy issues, but there are certainly ways to work around that. They can, for example obtain informed consent from clients who could give them permission to release their data to public databases for research. The data can also be scrubbed of identifying information, although for most applications it would still need to be matched with the patient’s medical history.

Still, this is all nothing new. Medical researchers have been working out how to conduct research while protecting patient privacy for years. No system is perfect, but generally speaking, we know how to do this.

There are two competing principles here. Science requires transparency, while health care requires privacy. Medical research therefore requires both simultaneously. It can get tricky, but as I indicated, researchers and regulators have worked out how to accommodate both principles reasonably well.

What, then, is Myriad’s interest? I would assume it is something proprietary, but they already lost their patent case on the BRCA test itself. They give no indication that they are planning to conduct their own research, but maybe they are quietly doing just that. Maybe they are holding out to be paid for the data. Maybe they are just paranoid and don’t have a well-thought-out reason.

It’s certainly a bad PR move. There is a general consensus that medical research has a high priority, and everyone should do whatever they can to facilitate such research. Part of this emerging consensus is that society, in essence, own medical research data. Pharmaceutical companies, for example, tried to argue that they own the research data that they paid for and did not have to make that data available. That argument did not fly.

Essentially if you do any kind of research involving people, that is a privilege granted to you in exchange for certain ethical guidelines and guarantees. One of those guarantees is that the results of that research will be made public.

Myriad might try to draw a distinction between clinical testing and research, but the lines there are clearly blurred. The new HIPPA rule clearly supports the notion that clinical data will also be treated in a way similar to research data – being licensed to conduct tests on people means you have to follow certain ethical guidelines, including making all data available to patients.

So far the rules do not explicitly state that testing companies have to make their data available to public research databases. However, I would not be surprised if regulations go in that exact direction. The Myriad affair might, in fact, prompt such regulations.

This is all just a horrible PR move by Myriad also. When people are sick they feel vulnerable, and they want to feel that everyone and every organization involved in their treatment, on some level, actual cares about them, and about doing the right thing. No one wants to feel beholden to a heartless or greedy corporation when it comes to their health.

Myriad is acting squirrely in a way that makes it seem like they are more interested in their own profits than in their clients or the overall health of society.

I also think there is a sense, even if at the edge of our awareness, that we are all in this together. We are all people, and anything that improves our scientific knowledge of medicine has the potential to help us all and those that we love. On some level, therefore, impeding the advance of medical science for one’s own selfish interests feels like a betrayal.

At the same time, we live in a capitalist society, and companies have a right to make a fair profit off of their research and hard work. It is in all our interests for this to be true also, providing a motivation to do that research and hard work.

Each industry reaches its own balance among these various ethical and practical principles. The health care industry is especially tricky, but the regulations and standards have matured over decades and are now fairly nuanced and thoughtful.

Myriad should not fight these standards, in my opinion. They should embrace them, even go a little beyond them in good faith. Find a way to provide their data to researchers. The bean counters at the company need to appreciate the industry in which they exist. They are not selling widgets. They are dealing with people’s health.

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