In the car the other day, while listening to a radio talk show, I heard a new term that piqued my interest. The show was about our economic future over the next 20 years and the theme was “mass customization”. This is basically the physical extension of a trend we see now everyday on the Internet. The news we want is delivered to us is in ever more precise packets, tailored to our interests. The products served up on ads happen to be the color that we usually buy. Massive data centers are at work crunching every move you make to further delve deeper into your buying habits. We’re also now beginning to see the first mass customized products, like Google’s MotoX phone. Assembled in Texas in a robotic factory, you can choose on-line the color of the phone body and the buttons. Mass customization of the economy will mean that successful products will the ones that quench our unique tastes and needs. However in medicine, this may never happen due to a 1960’s regulatory apparatus being applied to 21st century medicine.
This week the FDA sacked early mass customization efforts in medicine like a defensive lineman pouncing on a quarterback. They sent a letter to a Google funded company, 23andMe. This start-up was run by Sergey Brin’s wife and was a darling of Wall street. The company performed inexpensive at home genetic tests using the same scientific equipment that you could find in any university lab. For a hundred bucks you could discover your genetic code and if you had a predisposition to a given disease. The company made clear that it’s tests weren’t to be used for medical diagnosis, just to provide information. 23andMe filed for a 510K under pressure from the FDA in 2012. This means that they had to prove that their “medical device” (test) was exactly like or very similar to an existing device. They couldn’t because there isn’t one, cheap and inexpensive genetic testing for hundreds of genes is a new concept. Hence the warning letter. Dissecting the letter reveals the FDA’s real concern with genetic testing and the future of mass customized medicine.
The FDA’s letter starts out with a nanny state example that makes little sense, but was clearly written for the press. It postulates that a false positive BRCA test (breast cancer gene) could cause a women to seek a preventative mastectomy. As the Washington Post brings up, mastectomies aren’t available over the counter, you can only get one if a physician agrees and the patient seeks genetic counseling (i.e. a second genetic test will be performed). So what was the real reason FDA went after 23andMe? Drug markets.
The next section of the letter lays out FDA’s true intent:
“Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment.”
Again, the letter has a section written for the press, but the prescription drug example they bring up (Warfarin) is heavily monitored by physicians with countless blood tests to adjust dose. No, the real reason is that Pharma hates genetic testing because FDA has pushed the expense of the drug approval process so sky high that it will hurt Pharma financially. For example, let’s say a gene shows that you would be unlikely to respond to medication X. Why would Pharma want this? It just reduces the size of the drug market for medication X. In fact proponents of genetic testing envision a world where their tests will determine which drugs you can and can’t take. In addition, these tests could show that for a certain segment of the population a certain drug is downright dangerous, leading to black box warnings on the drug, a modern commercial scarlet letter. Now while all of this is great for patients and doctors, you can see why Pharma would be plenty nervous about this trend. If non FDA regulated genetic tests became cheap enough, they could even be given away in exchange for advertising. Heck, in ten years your smart phone could be loaded with this information and alert you if used to buy a certain drug at the pharmacy or if those peanuts you’re about to eat may increase your risk of atrial fibrillation. Your phone, armed with this info, could be a big Pharma killing machine.
Why was yesterday a body blow to the mass customization of medicine? Because for customized medicine to happen, we need robust and cheap genetic testing. The FDA letter makes it clear that FDA is pushing 23andMe toward the much more expensive IDE device pathway, one where some sort of clinical trials will be needed for every medical indication. There is no way that 23andMe will survive as a consumer company if it has to spend 50 million dollars and 5 years on every gene it wants consumers to know about. Not even Sergey Brin’s billions will make those spreadsheets work. In the meantime, the promise of widespread and mass customized medicine goes out the window. In the end, we will only get the small amounts of customization that are blessed by the Pharma machine.
The upshot? While everything you buy from your clothes to your car 20 years from now will be customized for you, unless something changes, your medicine will remain stuck in the 1960’s paradigm of mass production, controlled by the 1962 FDCA. We need radical change of the kind proposed by the Manhattan Institute. Our regulations need to fit our customized medical future and allow it to grow without snuffing out bright lights like 23andMe.