Two women; one very rare genetic mutation.
Several years ago, scientists were thrilled to discover two patients, a Dallas mother and a young Zimbabwean woman, with the identical double dose of an extremely rare genetic mutation. Both women were found to have strikingly low cholesterol. That research set off a chase among three top pharmaceutical companies, Amgen, Pfizer, and Sanofi, to develop new drugs that could imitate the effects of the mutation, called PCSK9, in driving down cholesterol levels.
Early clinical trials now suggest that these drugs, PCSK9 inhibitors, are set to make these drug makers billions of dollars in profits. As the editor-in-chief of Harvard Medical School’s health publications put it in a recent article: “Every so often a medical advance comes along that rewrites the script for treating a disease or condition…That scenario just might happen in the next few years.”
Cases like these have prompted an ongoing debate among patient advocates, geneticists, and bioethicists. Should these two women with the rare mutation have been compensated with some form of equity or credit? After all, if it wasn’t for them, the PCSK9 inhibitors might not have ever been seen the light of day. Or is it enough that their unique DNA inspired a potentially life-saving drug for thousands of people with cholesterol-clogged arteries?
The Business Model Of Selling Data
Scientists today rely on thousands of donors to share their health information. This data is often stored in giant databases called biobanks, and combined with the medical record. President Obama is hoping to collect about 1 million people’s DNA for a huge new biobank, which would spur important medical research.
But new business models are emerging in the private sector that demonstrate the monetary value of our DNA. It’s a little known fact that 23andMe, the direct-to-consumer genetics company, makes its money by selling people’s health data to pharmaceutical companies in bulk for thousands of dollars. (23andMe’s business model involves analyzing its customers’ DNA on behalf of pharma companies, including Pfizer and Genentech.)
For this, and other reasons, some patient advocates are calling for patients to get a slice of the revenues. “I think there may be an economy emerging, in which we might want to figure out how to include them (donors) in the commerce that is taking place around clinical recruitment,” says Sharon Terry, founder and CEO of the nonprofit group Genetic Alliance, which advocates on behalf of people with genetic diseases.
