Are your genes your property?

In an earlier related post on biobanking, we asked our readers if they thought whether or not one's DNA should be private or publicly banked; the response was overwhelmingly in favor of privacy. Similarly, the notion of property rights in application to genes and genetic information presents serious challenges, as the Council for Responsible Genetics has long argued; their Genetic Bill of Rights includes a section that states "All people have the right to a world in which living organisms cannot be patented, including human beings, animals, plants, microorganisms and all their parts."

Now this issue is going before the courts: A group of patients, genetic researchers, and professional associations have filed a lawsuit against Myriad and the US Patent Office for patenting the genes known as BRCA1 and BRCA2. From the NY Times this morning:

"When Genae Girard received a diagnosis of breast cancer in 2006, she knew she would be facing medical challenges and high expenses. But she did not expect to run into patent problems.

Ms. Girard took a genetic test to see if her genes also put her at increased risk for ovarian cancer, which might require the removal of her ovaries. The test came back positive, so she wanted a second opinion from another test. But there can be no second opinion. A decision by the government more than 10 years ago allowed a single company, Myriad Genetics, to own the patent on two genes that are closely associated with increased risk for breast cancer and ovarian cancer, and on the testing that measures that risk.

On Tuesday, Ms. Girard, 39, who lives in the Austin, Tex., area, filed a lawsuit against Myriad and the Patent Office, challenging the decision to grant a patent on a gene to Myriad and companies like it. She was joined by four other cancer patients, by professional organizations of pathologists with more than 100,000 members and by several individual pathologists and genetic researchers.

The lawsuit, believed to be the first of its kind, was organized by the American Civil Liberties Union and filed in federal court in New York. It blends patent law, medical science, breast cancer activism and an unusual civil liberties argument in ways that could make it a landmark case. "

The complete article is accessible here; stay tuned as we follow this case, which could change the landscape in the field of genes and patents.

[Editor's note, added at 7:55pm, EDT: Colleague and WBP Supporter Art Caplan comments on this topic in his regular MSNBC column here, commenting that it is not always a bad thing when patent lawyers feel queasy. :>) ]

Should genetic researchers be able to share your DNA?

As promised (or warned--I guess it depends on whether you think this is an interesting issue), here is another thing to think about with regard to genetic biobanking studies.

So: say you've agreed to participate in a research study that is trying to identify whether there is a genetic contribution to breast cancer. In this particular study, the researchers will follow a cohort of women who have not developed breast cancer at the time of enrollment. The researchers will take blood samples and do physical exams periodically. They will also sequence your DNA. As time goes on, some number of women in the study cohort will develop breast cancer, and some won't. The researchers will look at the DNA sequences to see whether there are different patterns in the genetics of the women who develop cancer as compared with those who don't. If they find such patterns, they'll go on to investigate what those specific mutations do.

This kind of research, which is called a genome-wide association study, GWAS for short--because it's looking for associations between genetic patterns and disease--is a lot like a fishing expedition. (You can learn more about these studies in this archived Science Friday audio panel with Ira Flatow.) How GWAS's work has a couple of important implications. One is that, for such studies to work at all, researchers need really big datasets to sift through. Another is that the same dataset could be used for lots of different purposes.

For these reasons, and for efficiency and cost-effectiveness reasons as well, the National Human Genome Research Institute (NHGRI) is trying to develop plans to pool or share such datasets across different projects.

Think back to our breast cancer study example. If you'd consented to participate in that study at your local research university, how would you feel about your (de-identified) information being used by researchers somewhere else? Would you feel that you needed to be offered the chance to opt out of this "wide data sharing?" Or would you feel that your original consent covered such subsequent uses?

Here's another permutation to think about. Say the researchers did the breast cancer study, and in the course of that work they noticed that there seemed to be a correlation between certain genetic patterns and alcoholism or schizophrenia. Would it be ok with you for them to pursue this line of inquiry using your genetic information? Would you feel that you needed to be offered the chance to opt out?

You can read about the NHGRI policy, and the scientific community's reaction, in The Scientist, here. Salon.com ran an article a few years ago about a much smaller open-source approach to genetics, here (which is where the nifty kitty photo came from).

Four More Breast Cancer Genes, and Nary a Genetic Counselor in Sight

In a season two episode designed to coincide with a pink ribbon, breast cancer awareness campaign, Grey's Anatomy depicted a woman seeking a prophylactic oopherectomy and double mastectomy in reaction to the news she tested positive for BRCA-1 mutation after her mother died from ovarian cancer. Of course, being Grey's Anatomy, the storyline was played for maximum drama - but that doesn't mean we should simply roll our eyes and assume it creative writing at its best. Women do pursue prophylactic double mastectomies after testing positive for BRCA mutations, even though science is still out on the potential medical benefits.

With the news that four more genetic mutations have been linked to breast cancer, we are going to have to seriously consider what it means to have a genetic mutation, to look beyond the lab at the actual impact the geneticization of medicine is having on how patients are both viewed and treated, and consider what appropriate treatment actually means.