Genetic Tests: Companies Selling the Test Directly to Consumers
Would you like to be tested for the GRK3 gene to know if you might get a bipolar psychiatric disorder? This gene variant at best is present in 15% of patients with bipolar disorder and 5% of all patients who do not have bipolar disorder. Psynomics advertises that for $399 they will test a sample of your saliva for the gene and then send a 6 page report to your doctor. How about any woman watching or reading the ad from Myriad Genetics, even if she had no family history, would she desire to spend $3,100 testing for the BRCA1 and BRCA2 hereditary breast and ovary cancer genes where less than 1% of the general public carry these genes and when, if present, carries a 50% to 85% lifetime risk of breast cancer and a 15% to 60% lifetime risk of ovarian cancer? (Notice that the risk estimates are rather wide.) And for the BRCA, the company will perform the genetic counseling to the woman. There is much controversy still about the ethics and value of direct to consumer (DTC) drug advertising which is monitored by the U.S. Food and Drug administration. Now here comes genetic testing offered by direct to consumer advertising where there is no governmental monitoring. And then, what is the personal and social implications of such advertised random testing? This entire subject and more is presented in the June 2008 issue of The American Journal of Bioethics which is not web accessible without subscription, but one of the authors, ethicist Arthur L. Caplan, presents his view of the BRCA cancer gene testing sales pitch on Bioethics.net.
The title of physician ethicist Howard Brody’s editorial in the Journal sets the context that the genetic testing companies are following the pharmaceutical companies’ line to promote their product “Ask Your Doctor If This Genetic Test is Right For You”
But that’s the point, most doctors are not specialists in genetics and not able to make a decision at this stage of knowledge what are the benefits vs the risks of performing genetic tests on healthy people, particularly the young. They also are not skilled in genetic counseling of their patients regarding the value or the interpretation of the results of the tests. So then it becomes the responsibility of the individual with the “help” of the gene testing company to decide whether the results are worth the costs, the emotional consequences, unnecessary medical procedures and treatments, the implication for families and the impact of disclosure of the results of the testing on the individual’s insurance and job.
If genetic testing companies find that broadcasting direct to consumer advertising is simply their right to freedom of speech (and make some money) and ignore the ethical and social consequences of what they are doing, they should be held accountable for the negative consequences and not shift the responsibilities to anyone else including the physicians of those readers and viewers to whom they advertise. ..Maurice.
posted by Maurice Bernstein, M.D. @ 10:06:00 PM
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1 Comments:
This is where Kaiser does it right, and indemnity insurance can't or won't. For example, patients who want BrCA testing in Northern California Kaiser go to a class first, taught by a genetic counselor, to learn about the risks and benefits. We do not usually order the test unless the patient has taken the class or met with a genetic counselor, although we'll often outline the issues briefly in the initial phone call or meeting with the patient who desires testing. If there's a language or learning barrier, they can get one-on-one counseling; if there's a mobility barrier, this counseling can be done on the phone. If they then want to proceed, their FH is reviewed by the geneticist to confirm that it's a reasonable test to send using current guidelines(which determines coverage - the patient can still get it even if it's totally unreasonable, she'd just have to pay and at least she'd be well informed about what a waste of her money the test would be. She can also appeal the decision for medical review.) At times, if indicated, Kaiser will arrange counseling and testing for the index cancer patient, rather than the Kaiser member, as a first step, even if the index patient isn't a Kaiser member. This is the good side of prepaid health care - you can DO stuff like that that makes sense. It makes financial and ethical sense for KP to test only well-counseled patients, and at times it makes more sense to test the index patient first, rather than their own members. It's cheaper AND better to do a group class with a genetic counselor than one-on-one counseling by physicians. (I agree with KevinMD - physicians are not well-trained to be genetic counselors.) The group class for a a couple of hours is better quality information than an impromptu counseling session as a 2 min part of a 20 min MD visit. The worried-well can get full information from the class, saving the MD time for things that MDs are well-trained to do. (Indemnity insurance basically FORCES the physician to do the counseling for the worried-well at an shockingly low hourly rate, saving the insurer money but it is clearly suboptimal. They often won't cover genetic counseling for the worried-well, though you can get it for the positive family history, if available in the community.)
Other insurance companies could do it Kaiser's way, but they don't have the benefit of owning their own genetic counselors and classrooms and labs, so it's logistically more difficult for them, and they are currently benefiting by having the PCPs basically eat the cost of the worried-well counseling, so they have little motivation to change. Kaiser's motivation is to pay MDs only for MD stuff, not for other-provider stuff, because MD time is more expensive.
(KP has other classes for other cancer genes; I'm just most familiar with the BrCA class since I'm a KP ob/gyn - but I've worked in the so-called insured world before this, so I have some grasp of the issues.)
For those of you in outlying areas who need a quick reference for BrCA counseling, our site has an excellent webpage about the issues which does not specifically refer to the KP process: https://members.kaiserpermanente.org/kpweb/healthency.do?hwid=zx3000#zx3000-WiseDecision
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