Tuesday, November 1, 2011

Who owns the genetic tests

As genetic testing gains ground as a way of learning if one is at greater risk of a hereditary ailment, shouldn't the testing be available at multiple labs? This would allow for competitive pricing and more importantly - a second test to confirm or refute the original one's result.

Using the BRCA - breast cancer gene - test (BRCA - say it as bracket but with an 'a' instead of an 'et' on the end so you don't have to feel stupid saying the letters B-R-C-A) to determine a woman's risk of hereditary breast cancer as an example, currently there is only one lab who does all the testing in the US. They hold a patent on it and are ordering other labs to cease and desist in offering the same test. They made $350 million last year and charge $3000 per test which may or may not be covered by decision. As a result of the test, you get a score telling you how likely or unlikely you are to develop the hereditary breast cancer. One end of the scale is very high risk and the other end is very low risk - leaving a middle full of 'maybes.'

If you get a maybe, you have no way of getting a second test. You have to rely on the one lab to have been accurate when making a life changing or life saving decision. I am sure they do their tests following all proper protocol but there is always a margin of error - a bad sample, lab tech having a bad day, etc - there is always a degree of subjectivity that can influence what should be a basic test.

As this article explains:

"The BRCA1 gene was discovered by a Berkeley research team led by geneticist Mary-Claire King in 1990. Over the next few years, scientists raced to sequence it. Myriad’s got there first. But did the company’s work in isolating and cloning the gene transform it from a “product of nature” (which can’t be patented) into an “isolated composition of matter” (which can)? The ACLU – together with about 150,000 patients, scientists, and medical ethicists – contends that the answer to this question is no.

In 2009, the ACLU filed suit against Myriad and the US Patent and Trademark Office, arguing that the company’s BRCA patents are invalid and unconstitutional. In 2010, a New York federal court decided in favor of the ACLU, but this July, that decision was overturned by the US Court of Appeals. “Cleaving” the gene from the body, that court found, renders it eligible for patent protection. The ACLU now intends to bring the case to the Supreme Court."

In the meantime people are making life changing or life saving decisions based on this one lab. And the real question it comes down to is are their patents hindering research that could help save lives of others? Researchers should work together but the patents that Myriad seems to be hiding behind are impeding the collaboration that could greatly speed up break throughs.

Genetics are not something that are made, they are not created, they are part of nature. So why can they be patented? When do patents become things that stop research instead of helping it? Why can't Myriad's researchers collaborate with others? Let me take a wild guess - someone is only interested in the money.

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