THE BLOG
02/19/2013 04:56 pm ET Updated Apr 21, 2013

Can I Ask You a Personal Question?

The government is going to possess your genome. More importantly, your insurance company is going to demand your genome... if you want insurance. They are calling this invasion of privacy personalized medicine. I went to their conference in Palo Alto last week -- PMWC, Personalized Medicine World Conference. At first take, it sounded ominous and smelled like another Big Brother "move," maybe bigger than Facebook.

Well, no. Facebook selling your data to the government is still probably bigger. But, both your insurance company and the government are going to tell you that voluntarily giving them your genetic information will be for your own good. That doesn't sound good. Could it be good?

Maybe. As a well-known critic of what the medical-industrial complex likes to call the standard of care, I have to give this terrifying-sounding development in the future of medicine a definite "maybe," bordering on "most probably" good for you.

For example, if I told you that once your genome is elucidated and recorded, you will be prescribed fewer drugs, thus reducing your risk for drug interactions and physician errors, you'd agree that's good for you, right? Even I can't find any fault with testing potential drugs on stem cells in a petri plate made from your exact genome to cure your exact disease, instead of running human trials on people who may be nothing like you, all taking many years and hundreds of millions of dollars. Considering how science and medicine proceed now, it actually all sounds kind of brilliant.

The conference this year is the fifth one, and I've attended the last four. I haven't reported sooner because it was important to see how it all shakes out. This groundbreaking, earth-shaking, we-didn't-see-that-coming development in health care of targeted molecular treatments and companion diagnostics will change the treatment you are offered in a way that hasn't occurred since blood typing for transfusion, anesthesia and antibiotics all made surgery really possible. Oh, maybe insulin synthesis for Type 1 diabetes and the polio vaccine compare in the sense of lives saved, but personalized medicine is about to change the options for health care in short order in ways we can't even imagine.

Year one of this gathering, I stumbled into the Museum of the History of the Computer only knowing I was attending a conference on medicine called personalized medicine while my husband attended a conference in his field. I had no idea what that phrase might refer to. There were cars in the lot. Upstairs on the second floor, the hallway at the top of the stairs was lined on either side with maybe five or six "exhibitors." By the time I got into the auditorium, I had surmised the exhibitors were gene sequencers. In the auditorium, I saw maybe 20 round tables for eight each, a very small conference. I picked a table at the back in the corner with an open seat because one of the guys was wearing a bow-tie. The rest of the crowd looked pretty stiff (dry).

As the stage came alive, it came to light that Tal Bahar of Silicom Ventures is the genius behind PMWC. You see, the gene sequencers in research triangle were in trouble. They all had taken venture capital over time to find the gene for, (fill in the blank) say, cystic fibrosis, Alzheimer's, ALS, diabetes, and on and on. The problem turned out to be: There is no one gene that causes any of those diseases. It's more like a cascade of hundreds of thousands of genes tripping each other in ripples like a pond. So, if you can't find the gene to cure a disease, where's the money? So why ever sequence anyone's genes if there's no happy ending for the pharmaceutical industry? How can they create a drug to affect that rogue gene that it turns out doesn't really even exist?

The first speaker in 2010, a scientist who had sequenced his own genome for about $50,000, predicted that in five years the cost would plummet to a $1,000. Four years later, he's just about on target, price-wise. He had also discovered quite a few new SNIPs (single nucleotide polymorphisms). The genes make us human, the differences in our SNIPs make us individuals. As individuals, we use drugs differently. He went on to use the examples of Warfarin, an anti-coagulant or blood thinner, and Tamoxifen, an estrogen receptor blocker used in breast cancer treatment.

Warfarin is used to stop a patient from making blood clots post and pre-cardiac events. A little bit does nothing. The right amount can be helpful. Too much, and the patient bleeds out in the corner like a rat, because it's based on rat poison. The difference in dosing on the individual level depends on which SNIPs you have. Tamoxifen, the darling of breast cancer treatment for over a decade, actually appears to work 98 percent of the time, but only on 30 percent of all of the patients who take it. The other 70 percent have an enzyme that neutralizes it in regard to breast cancer benefit, but they still have 80 hot flashes a day, their bones are crumbling and their brains are scrambled because of blocking of estrogen elsewhere. Quality of life would be a memory for these women, if they could remember anything.

So, doing someone's genome, who needs these drugs and getting the dose right or eliminating suffering if the drug wouldn't work anyway is a win/win... a mitzvah. I'm actually riveted to be in a group of people who have solved their own financial problems by using their unique technology for good, not evil; if it had only ended there. I was impressed, and it hadn't even gotten interesting yet.

It was then announced that there was a surprise "guest" that they (PMWC) "had to let speak" -- that's a quote. Why would anyone ever introduce a speaker like that? I guess it depends on who the "guest" is. In this case, it was the FDA in faux-Chanel suit, man haircut, over-50 incarnation of a woman, telling all the nice gene sequencers that they and their technology had been reclassified by the FDA. They were to no longer be "service providers" or sequencers selling that service; they would now forever be "device manufacturers." This move by the feds would cost them a few million each to reclassify and a two-year setback.

A distinct audible ripple of shock went through the audience and then through me. Suddenly, it all became clear. Those pharmaceutical companies stood to lose a large percentage of their market, not just in Tamoxifen, but in antidepressants, anti-inflammatory drugs, and God knows how many other drugs, unless they could replace them with other debatably-effective new drugs. So, they sent in the FDA to buy time.

Part Two

As I approach the Museum of the Computer a year later in 2011, there's nowhere to park. Lots and more lots of parked cars end on end. Weird. Could they really all be here for my smallish, geeky convention of science do-gooders? They could.

They were. In the same museum, at the top of the same steps, in the same hallway that had six exhibitors on either side, there were two giant monitors and rows of chairs. The same auditorium was a sea of chairs, all the intimate round tables gone and lots and lots of cameras along the back of the room.

I hadn't actually studied the program beforehand, but I did know the NIH was giving an announcement of some kind. There was a panel-like set up on stage with giant monitors on either side of the stage and, this year, proper PMWC banners all around. This was different. Last year's chummy gathering had turned into a world-class event. This wasn't just an announcement by the NIH, it was their show.

As the place filled, the actors filed on stage -- Tal Bahar, some physicians and the big guns from the NIH. You recall, it was only last year that the FDA threw a spanner in the works to slow the sequencers down. What more could the NIH do to these guys this year to put them out of business? They could do a whole lot, actually, because their big news was really, really big news. Strangely, though, they began their announcement with the premise that they had come to do the sequencers a favor. The big favor, as they saw it, was to give the sequencers (get this) no more than a three-day heads up that they were essentially "out-played."

See, the roadblock the FDA created the year before only slowed down the sequencers just long enough for the pharmaceutical companies to get the ear (pocket) of the NIH. The National Institutes of Health had come to announce that a report would appear in the New York Times three days hence, that there would be a new research wing opening at the NIH, called the wing of translational medicine.

"Translational" medicine refers to the translation of gene action... gene products, to making medicine (new drugs to sell) using that information. Exactly the same information the sequencers were discovering when they accidently figured out how to eliminate approximately 70 percent of the pharmaceutical market's inept or, frankly, useless drugs, debilitating like Tamoxifen.

Now, with the help of the FDA, Big Pharma intends catch up, or try to.

For more by T.S. Wiley, click here.

For more health news, click here.

Subscribe to the Lifestyle email.
Life hacks and juicy stories to get you through the week.