Rebecca Skloot Journalist, Teacher, Author of The Immortal Life of Henrietta Lacks

October 31, 2010

US Government Says Genes Should Not Be Eligible For Patents

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In a historic reversal of a longstanding and controversial policy, the U.S. Government has just filed a legal brief saying that genes should not be eligible for patents, because they are products of nature.  This brief was filed in the case of ACLU vs. Myriad Genetics, in which the ACLU and hundreds of scientists and patients argue that Myriad’s patent on the breast cancer gene has inhibited the progress of science, and treatment for breast cancer.

This is part of a much larger debate over who should profit off of research on human biological materials, and what regulations (if any) should be put in place to require that scientists disclose potential profits and get informed consent from the patients these materials come from. As I said in the afterward of my book, The Immortal Life of Henrietta Lacks, most Americans have blood and tissues on file somewhere being used in research, but most don’t realize it, because the majority of research on human tissues doesn’t require informed consent:

“When you go to the doctor for a routine blood test or to have a mole removed, when you have an appendectomy, tonsillectomy, or any other kind of ectomy, the stuff you leave behind doesn’t always get thrown out. Doctors, hospitals, and laboratories keep it. Often indefinitely … Scientists use these samples to develop everything from flu vaccines to penis-enlargement products. They put cells in culture dishes and expose them to radiation, drugs, cosmetics, viruses, household chemicals, and biological weapons, and then study their responses.  Without those tissues, we would have no tests for diseases like hepatitis and HIV; no vaccines for rabies, smallpox, measles; none of the promising new drugs for leukemia, breast cancer, colon cancer. And developers of the products that rely on human biological materials would be out billions of dollars.

You can read more about that, and the history of the debate surrounding it, in this NY Times Magazine article.

The story of Henrietta Lacks illustrates the complexities of this debate better than any:  Her cells, known as HeLa, were the first human cells grown in culture, the first ever commercialized, and all without her consent. Samples were later taken from her children without consent to help further HeLa research, which led to some of the most important medical advances of our time, yet Henrietta’s family can’t afford health insurance. They’re hoping some of these recent developments might help change that.

And things do seem to be changing. In my book’s afterward, I wrote about four pending court cases related to these issues — just since the book’s publication in February, three of those cases have settled or been ruled on, all in similarly historic directions. For the first time in the decades long debate over research on human biological materials, cases are ending up in favor of requiring consent, and restricting commercialization of biological materials. There is great concern from some groups of scientists that this may inhibit their ability to do important research, which is where things stand today: It’s clear that the public and the courts believe new guidelines and regulations are necessary, but any new oversight must not slow the progress of science.