13
May
10

Walgreens blinks

Well, that didn’t take long!

On Tuesday I blogged about Walgreens announcement they were going to start selling a OTC genetics testing kit. I say were… Today they announced that they’re putting that idea on hold. As I predicted, the move started a firestorm and in just two days it was hot enough to get the big retailer to back off.

The FDA and a bunch of doctors and genetics experts piled on and put the brakes on the project.

“These kits have not been proven safe, effective or accurate and patients could be making medical decisions based on data from a test that hasn’t been validated by the FDA,” said agency spokeswoman Erica Jefferson, in an earlier statement Wednesday.

I’m having deja vu. That’s pretty much the same thing that happened when 23andMe and other gene testing companies went public back in ’07. Of course, some of the concerns expressed are not trivial.

The proliferation of consumer-marketed genetic tests has troubled many public health officials and doctors who worry that the products are built on flimsy data.

“The problem with all of these products is they’re based on incomplete, invalidated data and we don’t know what the impact on consumers will be,” said Dr. Muin Khoury, director of the National Office of Public Health Genomics at the Centers for Disease Control and Prevention.

The biology of how DNA variations actually lead to certain diseases is still poorly understood, although a number of public and private institutions have been racing to find answers.

That’s true. One of the themes of this blog is the unexpected complexity of genetic expression that has been uncovered during the past decade. Genetics scientists have been rocked back on there heels to the point of having to rethink some of the earlier assumptions in the field.

It seems that both the public and scientists have held some simplistic assumptions about how genes work. Scientists are making new discoveries nearly every day. So experts say with almost every breath these days: “Genes are not destiny!” Yep, the biology of what happens to us over time is much more complicated than that. So one of the most intriguing questions is: Why aren’t our genes destiny? If our state of being is an interleaving of genetic (internal) influences and environment (external) factors, how do they come together in the organism? That’s a deep issue that will take much more time to plumb. It’s one of those areas where scientists say: “It’s not fully understood.” (That’s science-speak for, “Duh!”)

My thought is that this is an opportunity to bring the public up to date and let them know the puzzle has 1,000 pieces, not 500 as first thought. We have been getting a trickle information about genetics for a couple of decades through media, but that volume is about to increase to a torrent. So where is the effort to help the public have a solid source of up-to-the-minute information? The federal government‘s agencies all have web sites with bits and pieces of the necessary information, but all-in-all the information on genetics is fragmented in a thousand places of variable currency and veracity.

So here’s my wild appeal: As a mainstay of our so-called health care reform effort, let’s extend the charge to our health and scientific agencies (NIH, CDC, NSF, DOE, NLM, etc.) to include making available to the public coordinated, up-to-date, evidence-based information on human biology, health¬†maintenance, medical and scientific frontiers, and a realistic perspective about the circuitous route by which scientific progress is made . Make this available through state-of-the-art communication technology, i.e., the internet and its future derivations. Every citizen, doctor, blogger, teacher, or mom should be able to access reliable information on anything they hear about health in a few swipes of their smartphone. This is a big job and will take money. Surely in the billions budgeted for health care reform in coming decades this would be worthwhile. And this could be an international effort both in information gathering and in paying for it. Health research is global and the findings apply to all of us. The US isn’t going to go to Mars by itself, so why don’t we throw in with all the nations facing the same health issues?

Learning is a process. Walgreens accommodation to the regulators may eventually turn out to be part of something positive.

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