At the forefront of retail medicine are the many companies selling genetic testing over the internet. But in recent months over a dozen of these companies have received cease-and-desist letters from state regulators. Biomedical ethics professor David Magnus explains the stakes when we lose the right to hear the story our genes tell about us.
BROOKE GLADSTONE: At the frontier of retail medicine, there are few ideas that are as seductive as genetic testing. Send in a little saliva or a few hairs, pay a few thousand dollars and get back a kind of genetic horoscope, what you might expect from your genetic destiny.
Heaps of companies now offer variations of this service, most of them over the Web, but being at the forefront of modern medicine has its drawbacks. Over a dozen of these companies have received letters from the states of New York and California in the last few months informing them that they failed to meet certain testing requirements and that now a doctor would be required to order up and deliver the results. Most of the companies are defying the letters.
David Magnus is a professor at the Center for Biomedical Ethics at Stanford University. David, welcome to the show. DAVID MAGNUS: Thanks. BROOKE GLADSTONE: How much evidence is there that customers are actually being misinformed? DAVID MAGNUS: Well, I think it’s too early at this point to know whether or not there’s actually errors in the information that’s being provided. But in terms of being misinformed, I think there’s pretty good evidence that the tests are misunderstood, and that can be seen even from the media coverage of the advent of these companies.
It was clear that the science reporters, who are actually fairly sophisticated compared to the general public, misunderstood the nature of what the tests really provided in terms of information. BROOKE GLADSTONE: Okay, so we'll leave the accuracy of the information aside for a moment. Let's start first with how the media misreported the story, in your view. DAVID MAGNUS: One of the stories was a very moving account by a reporter whose grandfather had died of a heart attack at 65 and his father had had a heart attack at 65, and he was certainly concerned that he might be at risk.
And he was surprised and pleased to find out that for the five or six different genes that had been identified in this test that were associated with cardiovascular disease, he actually had below average risk for virtually all of them. It looked to him like he probably was not at risk.
The problem with that is that most of the genes that are identified through a genomic process as opposed to a genetic process, through something called genome wide association studies, collectively probably don't really matter very much to his risk of heart disease.
And probably the family history and the fact that his father and grandfather both had heart attacks at 65 is probably far more predictive than anything you’re going to find from a genome wide association study at the present time. BROOKE GLADSTONE: And did he misunderstand those findings because he was misled by the gene testing organization he got the findings from? DAVID MAGNUS: I think it’s just hard when you use the language of genetics and the language of genes. What’s happened now is there are new techniques that make it possible to identify genetic contributions that are causally very, very minor in how much they contribute to a trait. That’s a very new development.
And it’s hard, because people are taking the mental framework that we've got for thinking about the Mendelian genetic traits and just assuming that we can apply it in a straightforward way to the new findings as a result of genome wide association studies. And I've seen that over and over again in almost all the coverage of different new genes that have been identified in this new way.
BROOKE GLADSTONE: I see that there is a problem here in education, but do you think the solution then is to place a doctor between a person and their genetic information? DAVID MAGNUS: Yes, I do. In general, and, in fact, here in California, it’s not that there’s a special requirement for genetic testing. It’s that if you’re going to have complex medical testing of any sort, you have to have a physician order that test.
There are risks of misunderstanding which could harm patients a cholesterol test or a bilirubin test or a CBC or any of a number of kinds of tests that can only be done by a physician. BROOKE GLADSTONE: On the other hand, there may be good reason to say that all those tests should be taken out of the control of a doctor’s order and that people ought to have more access to that information and be given credit for taking responsibility for their own health.
Patients still have a fundamental right to information, no matter how recklessly or irresponsibly they might use it. DAVID MAGNUS: Well, they have a right to that information, but that’s not the same as saying they have a right to get it in an unencumbered fashion. BROOKE GLADSTONE: It is the same as saying that. Why should the medical establishment stop me from information about me? DAVID MAGNUS: It’s about making sure that you understand and that there’s adequate informed consent for what you’re getting, so that we can avoid harm. In the story that the reporter wrote about cardiovascular disease, if because of his misunderstanding he starts thinking he doesn't have to worry about his diet and his exercise and has a heart attack at a much younger age because he misunderstood that information - that is very clearly a direct harm that’s a function of the genetic testing. BROOKE GLADSTONE: I understand the risk. I do. But the harm comes from the action he takes based on that information. The government, and companies, and all sort of interests around the world frequently say that certain kinds of information could harm us because of the actions we could take, regardless of whether the information is true or false.
I'm afraid that, in the case of my own medical information, in which the only real victim is likely to be me, if I take ill advised action, that if a physician says that he or she deems it unnecessary for me to take such a test, then I don't get access to it. DAVID MAGNUS: What we're saying is not that you can't get access to it but that you need to have a physician involved. If you get to the point where there’s generally understood standards and people start to understand the information pretty well, you start to have a clear understanding of what the harms are, you have a clear understanding of the efficacy of the tests for different traits, when you get to that point, that’s when you tend to allow things to go over the counter or direct to consumer. But you don't start that way. BROOKE GLADSTONE: How often do you get cranks like me who are really hung up on the freedom of information issue? DAVID MAGNUS: Oh, I would say that you’re probably in a majority view, but not so much from the freedom of information perspective so much as the free market arguments. There’s a lot of people who don't like the idea that there could be anything that would stop the ability of turning genomics into the next big area for Google or something.
And so I think there’s a lot of concerns that having physicians play a role — and there’s a lot of people who are worried that if people really understood more about genomics, we wouldn't probably have much a debate because nobody would want these tests. BROOKE GLADSTONE: [LAUGHS] David Magnus, thank you very much.
DAVID MAGNUS: My pleasure. BROOKE GLADSTONE: David Magnus is a professor at the Stanford Center for Biomedical Ethics.
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