Posting in Education
Will it be illegal for genetic tests to be sold directly to consumers?
This week, the Food and Drug Administration made it clear the agency thinks direct-to-consumer tests need to be ordered and reviewed by a physician. The panel discussions caused a little bit of a brouhaha, especially for long-time proponents of genetic testing. The trouble is, once you turn the green light on for regulation, it would be hard to go back directly to the consumer.
The Molecular and Clinical Genetics Advisory Panel's sentiment doesn't come as that much of a surprise, considering the FDA's previous stance on the issue of genetic testing. Previously, the FDA sent out letters to five major DNA testing companies, telling them that their medical devices need to be approved before they are marketed to consumers.
Although, I do have to admit that even though I took three genetic tests from three different companies, it's unclear that had a doctor ordered the test for me that it would have made a difference. I took most of the results with a grain of salt. Had I been looking for my genome for answers, I might think differently about it and it would have impacted me more than it has. But it didn't. I'm not alone. The New England Journal of Medicine published a study that said direct-to-consumer genetic tests didn't make people feel anxious. And, the study found that only 10 percent of consumers took advantage of the free genetic counseling sessions.
As I mentioned before, when Pathway Genomics announced their plans to sell DNA tests at Walgreens, it certainly struck a nerve with the already-squeamish FDA — as it should. DNA tests aren’t the same as selling a pregnancy test over-the-counter. There is no simple “yes” or “no” answer that you will receive, and the meaning of results are often much more complicated than that.
The FDA's watch over the direct-to-consumer genetic testing field will likely continue, as testing gets cheaper and reaches more people. SmartPlanet spoke to Joann Boughman, an expert who spoke at the FDA panel this week. Boughman is an executive vice president of the American Society of Human Genetics (but says her responses are hers and do not represent the views of the society).
SmartPlanet: So you were at the FDA hearing. What was it like?
JB: I think that the FDA has clearly made its decision that they will use their authority to regulate genetic testing.
They have said that before.
The FDA sent letters to companies (cease and desist or more casual, "talk to us" letters). Now, they've made it clear they are going to use that authority.
The questions they were asking were...
How should we regulate these direct-to-consumer tests?
Should they be allowed to be sold direct-to-consumers?
If so, which ones?
What about analytical and clinical validity?
Should it be the same as tests that are not sold direct-to-consumers?
What should the label be like? What kind of information should be on the package and on the results?
Surprisingly, there seemed to be a consensus around the fact that any genetic test that is a health-related test should be interpreted and the results should be reviewed by a qualified health professional, whether if it's a carrier, predictive or pharmacogenetic tests.
But this [regulation] wouldn't include ancestry tests or traits such as dry ear wax.
HIV tests are sold this way. You can order the tests, but a health professional has to call you back to give you the results.
SmartPlanet: So basically you'd need a doctor somewhere in the process?
JB: The feeling was, the direct-to-consumer tests should be ordered by health care professionals. The testing should performed by a Clinical Laboratory Improvement Amendment (CLIA) certified lab, and be interpreted by health care professionals if they are a medical test.
SmartPlanet: So what else happened during the panel?
JB: There was a lot of discussion about the interpretation, odds rations, absolute risk, complications depending on population, and single-nucleotide polymorphisms (SNPs) you are using. It's not a straightforward answer. There are several steps. The consumer must understand the difference between high or higher risk. If they don't understand details, the consumers should have a good concept of the population risk. Even doctors not properly trained would understand from patients the different rates of type two diabetes among African Americans, and Europeans and Asians. The doctors would get the concept quickly.
Doctors only spend seven minutes with patients, but the results are a hundred pages worth of test results.
SmartPlanet: What's going to change?
JB: Direct-to-consumer testing companies will have to look closely at their business models. They are putting out good educational materials. They are being responsible in the amount of information they are giving the patient. Some companies are really bad as well. Some companies that have come and gone. One was testing for responses to different nutrients and they were selling nutritional supplements. Obviously, there's a conflict of interest there. That wasn't a good model. Most of those companies are gone already.
SmartPlanet: Have you gotten your DNA sequenced?
JB: I have ordered the tests, but haven't gotten the kits yet. In Maryland, you can't be tested. I had to have the kit sent to my nephew in Virginia. I haven't seen him to have it delivered.
That issue was also mentioned in the panel, state regulation can vary as well.
It seems like the scenario it sets up as if it's the FDA against the corporate world. That's not really the way it's set up. The FDA is a protector of the consumer. It protects the consumer from bad practices.
SmartPlanet: What's the main concern about selling the tests directly to consumers?
JB: The concern is about [test results that are] false positives and false negatives.
There are some challenges to medical practitioners... physicians can be paternalistic. There are some medical practitioners who are pretty directive. In genetics, we've tried not to be. Given that background, nobody is denying the patients' the right to know. In some sense, some think any FDA oversight would block the patients' right to know or obtain knowledge about themselves. Taken to the extreme, that is true. But that's not the goal of the FDA or the community that is suggesting that the tests be regulated more stringently. It is such complex information. Medical professionals should be involved in the process [of interpreting the results to patients].
SmartPlanet: How do you see genetic testing playing a role in the lives of patients?
JB: It was interesting that we were talking about direct-to-consumer tests, when the lupus drug was approved based on underlying genetic information. You can test for responsiveness to certain drugs. For those drugs that do have pharmacogenetic tests, the results can recommend the dose [and the brand].
For example, before someone is given the Warfarin drug [a blood thinner], the label indicates doctors should test the patient before administering the drug for the recommended dosage [because too much can be lethal and not enough can be ineffective]. But not a lot of doctors use those tests that go along with the drugs.
It’s going to take us a while to get us to the point where pharmacogenetics is in everyone’s practice. It takes time to do the trials, and prove the safety. It’s catching on as we understand the molecular targets.
Related on SmartPlanet:
- Geneticist George Church: Sequencing human ‘high genome priority’ for China
- FDA wants to regulate direct-to-consumer DNA tests
- Pathway Genomics slapped down by the FDA
- Who should control knowledge of your genome?
- 23andMe blames human error for DNA mix-up
- Personalized medicine: Check your DNA at the door
- A DNA master chef, cooking up genomes
Mar 10, 2011
The FDA should be abolished. Bureacrats' skin-saving denial of life-saving medicine to those who are terminally ill, and even worse, disapproval of drugs which may save the lives of say 30% of those afflicted, has killed millions of Americans. It is not OK to restrict drugs from people who should be able to make their own choices, even bad ones. I wouldn't trust drug companies to provide good safety information, but 3rd parties paid by the people are the appropriate check and balance - think of Consumer Reports.
...I'd consider this their responsibility. But that's not the case. For decades now, the FDA has wanted to enter the business of "social engineering", which is not about food or drug safety, but dictating how we as private citizens should be conducting our personal affairs. This must stop.
The bottom line is, the FDA thinks doctors and other medical practitioners need more income from us poor, ignorant slobs. With all the total garbage they allow to be sold, they seem to be singling out only products that have a profit potential for the medical/government complex. There is nothing in any test - whether for drug abuse, pregnancy, or DNA - that has a medical effect on the user. Much like trying to regulate the content of the message in a fortune cookie, the FDA has NO regulatory authority in the first place...a fact that seems to have been overlooked in their rush to secure more income for their friends in the AMA. While I agree that it would most likely be more effective or 'smarter' to get the interpretation of the results from someone (almost certainly not your family physician, unless he is a trained geneticist!) who can fully interpret the results, forcing 'smarter' by fiat is not only unconstitutional, but will result in bootleg test kits that will most likely be as worthless as the other unregulated items one can find for sale in the backs of magazines or commercials on late-night television.
As a Ph.D. in Politics from UHK (university of hard knocks) let me assure you that the FDA is in bed with the pharmaceutical companies.
Great article as is the one released in May 2010 quoted in this article. Consumers have a right to know and purchasing this information directly from a company is no different that purchasing a pregnancy test at Walgreens. The ramifications may be more far reaching, but it is no different. The research I have done indicates the companies marketing these tests claim over 95% accuracy which is little different from pregnancy tests or self-administered diabetes tests which are sold in many drug stores and on-line. THE GOOD NEWS is whatever the results or predilections may be in these tests, DNA is not fixed as we one believed and it is subject to significant changes in expression by light and sound. If you are interested Google Nobel Prize Winner Luc Montagnier or go to our link here, read the article "DNA, Waves and Water" and consider its astounding ramifications. http://regenesisfeaturefilm.files.wordpress.com/2011/03/regenesis_cyberbridge-1300_1_dna-waves-and-water.pdf . And consider the 20 years of work by Peter Gariaev summarized in this article "DNA BioWave Computer" regarding DNA morphogenesis responding to light and sound waves. http://regenesisfeaturefilm.files.wordpress.com/2011/03/regenesis_cyberbridge-1300_2_gariaev-the-dna-wave-biocomputer.pdf . Our blog features a lot of information on this subject centered around its use in the storyline of a fictional novel. http://regenesisfeaturefilm.wordpress.com/
I do not believe that the FDA is in cahoots with the pharmacuetical industry, it is more like the industry does not like being regulated. I am not sure that the FDA will do the right thing either. It should make sure that the consumer is not given a bogus or useless test and that the quality of testing is good enough to not produce mixed results that require another round of testing. The article mentioned a direct to consumer company that also sells nutrient supplements; this is a conflict of interest. The comments on packaging and other things are part of the FDA's push for clarity in the products, that the product is what is claimed on the package. It probably would be smarter to get DNA testing done by a qualified doctor who can explain the result and also can verify that the result is correct for the patient. The direct to consumer market could play to people's curiosity and vanity the same way that astrologers and fortune tellers do.
...doesn't work. Even when you are 100% sure of the danger. They did tests for a specific disease 30 years ago in Italy as part of pre-marital counseling. Having the gene from both parents resulted in nasty things instead of healthy babies. It made NO difference. Love, apparently conquers good sense as part of 'all.'
The FDA is no longer protecting the consumer at all. See www.burzynskimovie.com. The plain fact is - the FDA now works for the pharmaceutical companies, not the public. Anyone who says differently is either blatantly lying, or simply inadequately informed.