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California's Misguided War on Self-Knowledge

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"Know thyself," urged the ancient Greeks. It's an admonition to self-discovery that in many ways is the basis of modern consciousness. But it's on the ropes in modern California.

As the New York Times reported yesterday, the California Department of Public Health is attempting to stop companies like Navigenics and 23AndMe from marketing its genetic testing services to state residents. (Disclosure: my company does marketing work for Navigenics.)

On June 9th and 10th, California regulators, the new genetic Gestapo, sent chilling letters to a total of 13 companies, informing them that their genetic tests "Could be ordered only by a doctor," not by consumers." Their intentions could not be clearer. Karen L. Nickel, chief of laboratory field services for the state health department has publicly stated "We started this week by no longer tolerating direct-to-consumer genetic testing."

This intolerance is directed at an activity that should be nurtured and encouraged. Deep and accurate genetic understanding - and the behavior change that comes out of it - will have enormously beneficial implications for individuals and their families on a personal level. And for public health, and health care costs, on a macro level.

California has adopted a policy that flies in the face of the forward march of science, that infantilizes consumers, and that will block us from access to information that can lead to early diagnosis, treatment, and lifestyle intervention to delay or mitigate any number of serious conditions from heart disease to diabetes to cancer.

Eventually, this genetic information will even lead to the personalization of drugs, since our unique biology determines how we process and respond to medications. That's part of the reason a particular chemotherapy agent will work in one patient, and not another. This important and explosive new chapter is called pharmacogenomics.

In short, we're at the cusp of a new era of personalized health and wellness, and consumers want to have - and are entitled to have - the genomic data to make it a reality. Wired's science blog has done a good job of capturing ten reasons why regulators shouldn't stick their meddling bureaucratic noses into gene testing.

There is nothing more personal or intimate than our DNA, and for any level of government to stand in the way of me or you having access to this information - directly and unmediated - strikes me as breathtaking intrusive. The constitution protects reasonable personal choice - decisions that do not impinge on the rights or freedoms of anyone else - from the hand of over-reaching government. Remember the legal battles over reproductive rights, decocted into the formulation of "keeping government out of our bedrooms"? Well, we now have to battle to keep government out of our bloodstreams.

For a state that is normally as enlightened as California, this is a surprising abuse of power. And California is not alone. Ann Willer director of the office of laboratory policy and planning at the New York State Department of Health, has incorrectly argued that "We think if you're telling people you have increased risk of adverse health effects, that's medical advice."

That's a big part of the argument against giving consumers access to gene testing, outside of a doctor-initiated setting. But how is Ms. Willer's definition of "medical advice" different than when the mobile blood pressure van shows up in the parking lot of Wal-Mart so the public can be screened? If someone trundles out of Sam's Club pushing a cart loaded with Cool Ranch Doritos, and a blood pressure reading pushing 200/120, and she's handed a brochure about the dangers of high blood pressure, isn't she being warned of an "increased risk of adverse health effects"?

"Information" is not "advice", and Ann Willer should know better. I can tell you that there's a nasty looking mole on your back without telling you what it is and what how to treat it. Based on New York State's definition of advice, every magazine that offers a "How Healthy Is Your Colon" quiz is practicing medicine.

And when you pop a Zantac - which not that long ago required a prescription - aren't you practicing medicine? Hasn't the FDA permitted millions to become unlicensed physicians by permitting so-called Rx-to-OTC "switches"? How is it that the same consumers who are adult enough to medicate themselves, and are assumed to be able to manage the complex interactions between these once heavily-regulated Rx drugs and other medications, must be treated like children when it comes to information about their own DNA?

Could it be related, perchance, to the economic stakes? Big Pharma generates massive revenue streams from these switches; as their old drugs are either going off-patent, or when newer, high-priced alternatives become available, they'll invest millions in sponsored clinical trials and research studies to prove that these now-hoary drugs are safe enough to be sold without a prescription. And that consumers will not abuse them.

Furthermore, anyone in California can drive down to their local supermarket or health food store and load up on any one of hundreds of nutritional supplements. These products are not regulated by the FDA, thanks to the Dietary Health and Supplement Act which Congress passed in 1994, in large part due to the lobbying of Senator Orin Hatch from Utah - not surprisingly, the home of many supplement manufacturers.

These products, which are taken orally, contain potent herbs and other active ingredients, many of which contain the same or similar compounds to those found in prescription drugs. The government has no oversight into the sourcing or manufacturing of these products. Potentially dangerous drug interactions are not indicated on their labels. Many studies have shown wide variations in formulation, in quality, in active ingredients.

Yet the same consumers in California who are free to buy products like LiverKleen Toxic Defense and Extreme Thermo Rush, can't find out if they are at increased risk for heart disease, cancer, or more than twenty other conditions. And as new correlations are being made and validated, that list grows. This is not just regulatory insanity, it's regulatory irresponsibility.

I know the people at Navigenics. I've seen their extraordinary scientific rigor, and their passion to provide people with inestimably valuable information about their genetic predispositions. They are relentless about the accuracy of the sequencing, and the fundamental science that underpins the correlation between genetic mutations and a personal risk analysis. They provide expert Genetic Counselors to interpret and explain the results. And, of course, Navigenics is equally relentless about the privacy and security of the genetic data they collect.

There are some who claim the real reason for the regulatory invasion we're witnessing is that doctors are being protective, that they want to maintain control - and revenue - by turning gene testing into a prescription-only activity. Want a test? See your money-grubbing physician.

I refuse to accept that cynical formulation. There's no doubt we are in a transitional period; as patients gain more knowledge about themselves, whether via the Internet or a genetic test, the doctor/patient relationship will undergo some natural changes.

It's true that physicians, trained in a different environment, have had to learn to deal with shifts in patient knowledge and awareness (and yes, a lot of what patients collect is a farrago of half-truths and no-truths.) And yes again, the medical community might be slow to react to cultural changes.

But let us never misconstrue inherent conservatism, which is actually an important attribute of science, as a selfish rejection of what is in the best interests of the public.

Understanding our DNA and its implications was once the province of science fiction. No longer. Parallel advances in the biology of gene sequencing, along with new technology that creates lower-cost scanning chips, now make gene testing available and affordable to millions.

Let's not let the government take away what science is finally making possible.