I Am Whatever You Say I Am

Friday, July 18, 2008

Transcript

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.

Comments [16]

Michael Kaelbling from Munich, Germany

Isn't it a logical fallacy for Mr. Magnus to assume that the goal--that those that get test results understand them--can only be achieved by handing them off to a physician? Where is the certification that the physician has been trained to correctly interpret and explain the results? Where is the procedure (a checklist, perhaps) ensuring that no points were skipped? How much time is the physician required to set aside for informing the patient with the aid of a native-language interpreter if needed, and would these burdens be a disincentive to adequate testing?

If the goal is the transmission of information, then the requirement should be that the information be included, in writing (in a choice of language), with the test results--much like a list of side-effects, counterindications, etc. should come with all medications.

By the way, I hope Mr. Magnus was using the term "physician" as a placeholder for "qualified explicator" and that he follows his argument to the logical conclusions: that physicians must, like drivers, be regularly recertified not just in factual knowledge but also in communicating with laymen, especially when new tests are introduced. and that non-physicians may also be qualified to explain tests--board certified geneticists, perhaps.

Aug. 03 2008 05:38 PM
Adrian Gropper from Watertown, MA

One aspect of consumer protection can be addressed by unbundling the test data from the interpretation. The conversation is around alternative interpretations: by the test vendor vs. a doctor; today vs. two years from now; based on one genetic test vs. multiple genetic tests; etc... Unbundling does not prevent misleading claims on the part of the lab or the interpreting agent but it may give doctors and researchers a larger base of population information (with patient consent, of course) and educate patients about alternative interpretations.

Should genetic testing have separate informed consent forms for the lab and the interpretation provider?

Jul. 30 2008 01:05 PM
Frank Corden from Connecticut

Clearly, we all realize that some genetic tests have a very high association with illness and that the association warrants a course of action. Some of the breast cancer genetic screens are a clear example here.

On the other hand, there are a range of genetic markers that are loosely associated with risk of disease. In this case the markers are less predictive than as an example the of common markers for heart disease including total cholesterol, good to bad cholesterol ratio, blood pressure, diabetes, body weight etc.

Lastly, there are a wide-range of associations of disease to genetic markers we don't know about, because they haven't been discovered yet. So in this case the absence of information ISN'T information of absence. It's this last category that I believe warrants much more education and communication.

In my mind, the regulatory community has the responsibility to assure that the information is communicated by the testing company in a manner a lay-person can understand. Composing these disclaimers should be the priority, not restricting access.

Good show, good topic. Deserves a much larger audience to seed what needs to be a much larger debate.

Jul. 29 2008 06:30 AM
Brooke Gladstone from Brooklyn, NY

In response to some of what I've read here (and we DO read these comments) I think it might be useful to clarify my views on this subject. For me, this is solely a freedom of information issue. I have no wish to extend that freedom to prescribing drugs or for that matter, practicing surgery on myself as Dr. Blackman believes my "slippery slope" would lead. Nor do I suggest that a layperson "would be better" at interpreting these tests - merely that he or she should have the right of access. And finally, I am firmly in favor of regulating the labs and these companies to ensure that the tests are done properly, the results are accurate, and no false claims are made about the value of the results.
Doctors cannot guarantee the quality control of labs - that is a regulatory responsibility. Doctors save lives. My life, too. I gratefully defer to their knowledge and experience. But if I wish to squander my own money on information I don't understand, that is my right. And if I eschew a doctor's advice and endanger my own health in the process, that is my responsibility.

Jul. 24 2008 09:58 AM
Brian from NYC

Lets be real - doctors and hospitals don't want the public to have access to these tests becuase it cuts into their billables. Pure and simple. The health care industry doesn't want to protect me from myself, it wants to rape me for every penny they can before I expire. (um...did that sound jaded)

Jul. 22 2008 10:28 PM
William Patterson, MBA, MSCS from New Jersey

Thank you to Brooke Gladstone for pressing the issue of patient right to self-referencing medical information. The only reason a specialist physician whom I saw recently was able to see his old records about me was because I provided them. He had changed hospitals and didn't have the old records.

I, too, see this as a rights issue. I'd rather have something I can take MYSELF to another physician than rely on physicians and their support staffs to handle it.

Jul. 22 2008 07:29 PM
Tera Eerkes, Ph.D. from Seattle

As a research scientist and co-founder of QTrait, a personal genetic testing company, I think it's imperative that we have exactly the type of discussion you held, in plain view of the public, so they understand that learning about our own genetic endowment will come with both rewards and potential complications, unknowns or risk of harm.

However, an equally critical issue is not that individuals will make poor choices after they have access to genetic data, but that institutions will make poor choices, after they have access to many thousands of peoples' genetic data.

Many DTC genetic testing companies have contractual clauses that let them use or sell your genetic information to third parties. This is often called "research" in these clauses. However, unlike true academic research, if you submit your DNA to these companies, you have no knowledge or control of where it goes, how it is used for study, or even the ability to recover it, once it is gone. Our current regulatory environment provides scant protection for the potential misuse of our very sensitive and important genetic data.

This is more worrisome to me than the individual choices people make. We need to have more conversation about this reality, and as soon as possible.

Thanks again for a fantastic program,

Tera Eerkes

Jul. 21 2008 07:18 PM
Laura Hays from Berkeley, CA

I weigh in with Jim Saling from Tuscon. What occurred to me but that Brooke missed was the issue of consumer fraud, being sold something by companies making false promises and giving results that taken by themselves could amount to misinformation. It sounds like California is objecting to companies selling information that isn't helpful or useful to a layperson. Instead of requiring a doctor as a mediator/interpreter, maybe a person would have to sign a very clear, simple document that recommends discussing the results with a doctor who knows you and/or is qualified to analyze the data.
I understand people from the United States don't like to be told they can't do this or that, especially when it involves their own health information and longevity. I think we could come up with a way to protect consumers and allow people to get the test, unfettered if they want to.

Jul. 20 2008 06:31 PM
Sam Blackman, MD, PhD from Philadelphia

Ignoring the important and obvious issue of cost (which should have been, but was not, discussed), as David Magnus accurately pointed out, testing is not risk-free. Brooke's "freedom of information" argument fails to account for the fact that no test is 100% accurate, and that it often takes the expertise of a physician to interpret results and consider the chances false-positives or false-negatives. The results of some tests, such as the genomic association tests discussed in the story, are reported as risks or probabilities, numbers which change dramatically depending on innumerable other factors (e.g., lifestyle, co-morbidities, etc.) and are susceptible change as new information is discovered. Physicians, who have dedicated theirs lives to the full-time study of science and medicine are not perfect at knowing not only how to interpret a test, but when to test and when not to test. What makes her think that a layperson will be better? And have she considered the consequences of the next step on the slippery slope, which, according to Brooke's argument would be free access to therapeutics, because after all, don't we have a right to alter/modify/treat our own bodies as we see fit?

Perhaps Brooke should consider as a corollary to Sir William Osler, who said "A physician who treats himself has a fool for a patient", that a patient who treats him/herself has a fool for a doctor.

Jul. 20 2008 12:26 PM
Jim Saling from Tucson

It seems to me that the problem is not the right to information about self but misrepresentation of the product. I think that people have the absolute right to know whatever they want about themselves. But, it is unethical and most likely illegal to portray the information that you are receiving as something it is not. Regulation of this industry should not be focused on access to the tests but how the results are communicated. This testing will only provide information about your genetic makeup. It is possible to have genes in your DNA that are not expressed. In addition, there is not enough information for any of these to be conclusive in any sense of the word.

Jul. 20 2008 11:58 AM
Jonathan from Nashville

Brooke should have taken one more step in her argument. Brooke argued that information should be free, and that the worry comes when people act on the information. Magnus argued that information needed to be properly interpreted by a doctor in order to protect us from ourselves. But nearly any serious medical treatment that an informed (badly or not) patient will seek will come from a doctor. So doctors are already a part of the process, and right where Brooke wants them--at the level of action. Moreover, this is right where the doctor SHOULD be--where the informational rubber hits the clinical/therapeutic road. Brooke is right.

Jul. 20 2008 11:01 AM
Robert from NYC

Good for yo Brooke, it's still not up to anyone else to hold back information about "me". If I decide to do something about it, right or wrong it's my problem. This guy is wrong as far as I'm concerned. Whether or not I know about genomics is not the issue.

Jul. 20 2008 10:48 AM
Thomas Viveiros from Franklin, MA

I was very excited to hear Mr. Magnus' interview on NPR! It appears that he is one of the few people that understand how genetic information should be distributed. We are all fortunate to have such intellectuals in charge of our personal information.

While we’re at it, maybe we should work on forming a group to control the media. It appears that people are voting for candidates based on incorrect and biased media information. This could cause us to harm our country by not understanding ALL of the nuances of a candidate’s position. If we could only have a licensed group of highly-educated (probably only from Stanford or U. Penn) media journalists interpret what the candidates REALLY mean. Since I don't have the mental capacity to understand such complex information, I thought it would be great to have someone else think for me. Thank you so much for being smarter than me. Down with Wikipedia!!

Jul. 20 2008 09:54 AM
Robert Homer from New Haven, CT

As usual, the answer depends on how the question is framed. If the question is whether we should "lose the right to hear the story our genes tell about us", the answer is in favor of our rights. However, if the question is whether private business should be allowed to market complex medical testing to a largely uninformed public, the issue becomes one of consumer protection. The logic behind such regulation would then be the same as any other consumer protection legislation including the regulation of medical practice in general. Of course, the implementation of that process is open to discussion but Brooke would presumably not be as passionate about that discussion as she appears to be here.

Jul. 19 2008 08:46 PM
Richard Malik from Great Barrington, MA

As a physician, I see many patients that want some type of laboratory test that, when interpreted correctly, will not answer their health questions or have much bearing on their treatment.

Unfortunately, sometimes other physicians are responsible for these misunderstandings. Going to see a doctor before getting a test does not ensure smart testing.

Before a patient chooses to get a test, they should be told what the test can and what it cannot do. Information provided to consumer before direct to consumer tests is often woefully incomplete.

John's point about not being trained in evaluating genetic tests is not the case. In my experience, getting up to speed on a new test requires a few minutes of conversation with the laboratory's technical support staff. And then, clinical judgement and being able to put the test results into perspective with the patients medical history, family history, current medications, etc. helps to determine the course of action that makes the most sense.

I think a possible answer is sitting down with a doctor before getting the test to make sure you understand what the test can do, what it cannot do and its cost compared to other alternatives. Everybody has the right to get the type of healthcare that makes sense to them; to have doctors that support them, answer their questions, and inform them of their options; and to purchase whatever they want from any company they want (huckster or no) as long as they make an informed decision.

Jul. 19 2008 05:04 PM
John Smith from Southfield, Michigan

I agree that freedom of information should trump our supposed "protection"--not only as a matter of principle, but also because this will be no protection. I agree with the California state spokesman that most tests are deceptive or confusing, but doctors practicing now have not been trained in evaluating genetic studies, and can't be relied on for good advice; open discussion will get us educated much more quickly.

Jul. 19 2008 08:25 AM

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