July 15, 2010
FDA Wants To Regulate Genetic Testing
The FDA wants to get more involved in controlling the genetic testing industry.
In a prelude to overhauling its regulatory oversight of genetic diagnostic testing, the U.S. Food and Drug Administration will convene a public meeting next week to gather input from test makers and others.
I would prefer the FDA and like regulatory agencies stay out of genetic testing except perhaps to test for error rates and publish the results. The rate of innovation will be faster with less regulatory involvement.
Yes, genetic testing will serve as a cornerstone of personalized medicine - but only if it is allowed to grow rapidly without big costs involved in getting regulatory approvals.
The event reflects a turning point in genetic testing, a cornerstone of personalized medicine. Once mainly the domain of rare diseases, scientists have discovered a growing number of genetic variations linked to both the risk of more common disease and patients' response to drugs. The number of genetic diagnostic tests has expanded rapidly, and tests have become increasingly complex, making it more challenging to interpret and act on the results.
Genetic tests are data. The flow of genetic testing information is like the flow of so many other kinds of information: increasing rapidly, growing by leaps and bounds. All that data should flow unhindered by regulations.
The FDA does not see doctors capable of interpreting genetic test results. I'm thinking they'll use web sites that will pop up to do genetic sequence data interpretation.
"We don't think physicians are going to be able to interpret the results; they are relying on the labs that make them," says Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA. "So we think a third party should assess these devices."
Individuals shouldn't even need to go to a doctor in order to get their genes tested or fully sequenced. Testing and sequencing services should be available to accept tissue samples via web sites where people pay and then send in tissue samples.
Access to testing services without need to see a doctor should be allowed for much more than just DNA testing. Services for testing blood and assorted excretions (urine, stool, hair, nails, etc) should be available to the general public. Also, as microfluidic devices make mini home medical testing equipment practical we should be able to get a blood panel or other tests done at home.
I think the FDA is pandering to the AMA, who does not want to be cut out of the loop on genetic testing. The MD's make a lot of money as "gate keepers" and direct to consumer genetic testing threatens some of this revenue.
It always about the dollars, always about the dollars.
The public health community worries about, well, the health of the public. This has two pieces: (1) the public should be healthier, and (2) health disparities should be reduced.
Consider the second part of the reigning dogma, reducing disparities. Genetic testing will likely get in the way of that. DTC offerings will mostly attract educated people with disposable income--and they are already disparately healthy. So any benefits of DTC testing will just make matters worse.
I suggest that the FDA intercept packages going to Navigenics and 23andMe. Samples from unhealthy people are passed through. Those coming from wannabe customers with above-median health get tossed. FDA enforcers are sent to the return addresses, and hit the residents on the head with hammers.
That way, the companies can develop their technologies, while the worrying health-disparity gap is narrowed. At the same time.
Despite the high level of conservation of most of the human genome, it has become apparent that significant variation in non-lethal gene "varieties" occurs, and that these varieties, by themselves or in combinations, can have significant (or quirky) results on human metabolism.
As a species, we humans are likely not all as equal, genetically speaking, as we might wish to think. Individualized medicine must therefore be allowed to develop.
"I would prefer the FDA and like regulatory agencies stay out of genetic testing except perhaps to test for error rates and publish the results. The rate of innovation will be faster with less regulatory involvement". Precisely put, Mr. Parker.
I agree about gatekeepers. I do not want to see all medical testing to go thru doctor's offices.
DNA sequencing is about to become extremely cheap. Ditto for many other types of biological testing. Microfluidic devices will enable cost reductions by orders of magnitude. We should be able to get at that flood of data directly and use web sites to analyze it. Our own smart phones should analyze and report on our health in real time.
No kidding; It's bad enough that I have to take an hour off from work every three months to get my blood drawn for a PSA test, (Since the prostate cancer.) a week later I have to take two hours off from work to go back to the doctor, just to get the freaking number. That's insane. Except, of course, that it isn't insane, from the perspective of the doctor being paid for the visit.
The doctors have a strong incentive to remain gatekeepers to test results. The regulators have been captured by them.
Brett Bellmore, Agreed on regulatory capture by doctors.
We should be able to walk into a drug store and have pharmacist or certifed assistant draw blood or accept a urine sample (or spit or hair or nails) and get results on a web site and/or in email.
Drug stores have pharmacists in them many more hours per week than doctors' offices have doctors in them. Drug stores are convenient to go to. They tend to be on main drags. They are open 12+ hours per day 7 days per week.
I think the doctors may eventually lose control once microfluidic devices make home medical testing cheap and easy for a large assortment of blood components. Once you can buy a $5k box that tests most of what you'd ever want to know to detect disease development you'd be spending what we used to spend on home PCs back in the 1980s.
Will the sale of those $5k devices be restricted to doctors' offices? The sellers will want a market that is 100 or 1000 times larger. So they are going to push for wider availability. First people with diabetes and other chronic diseases will get the lab-in-a-box devices for their daily testing. Then they'll let other family members use these devices. Then let neighbors. Then they'll ask why can't everyone have one.
Americans will send samples abroad, get the results online, and follow up domestically if there is a concern.
While I don't want to keep doctors as the gatekeepers to health care, I do think genetic testing and microfluidic testing devices need to be well-regulated. False positives in these medical tests would unnecessarily scare healthy people and could lead to a lot of wasted money in further tests to disprove the (unregulated) test.
Even worse would be false negatives. What if a microfluidic STD testing device has an abnormally high rate of false negatives? Lots of people harmed! For genetic tests, a false-positive could lead to someone having children when they might otherwise not (think Huntington's disease).
As much as I hate to extend benefit of doubt to the FDA, there is a reasonable case for regulation here. Part of the issue, I'm afraid, is that many of these genetic markers indicate disease states (or potential disease states) that affect the cost of medical treatment and the patients' life expectancies. The worry in the medical community is that this information will get out to insurance companies (life and health) and elevate premiums based on these facts. Especially given people have no real control over this issue, it does seem unfair that a test to help them may well harm them by raising their insurance costs (hence the rationale for regulation).
Further, as random alludes, these tests are imperfect. Not only do false positives and negatives exist (and frequently allowed for by the MDs who get the reports), but the underlying pathophysiology of the disease may be incompletely or incorrectly understood. This means that the gene in question may not affect the disease state after all. Or may only affect it in conjunction with several other genes (Most complex traits aren't nearly as easily deduced or as binary as Mendel's pea plants were). Either way, the patients whose premiums are affected may not actually have higher (or lower) costs, despite the current state of the art medical thinking.
Frankly, if I was going to worry about the results of a genetic test reaching an insurance company, I'd worry a lot more about it if the test were being conducted through a third party routinely being compensated by the insurance company, than if I were directly paying for it.
Are we to go along with the notion that people have no right to find out something about their own bodies if the government thinks they might make a wrong decision based on the knowledge? Sounds like time to get out the tar and feathers, if that's the way our government thinks about the citizenry.
> Are we to go along with the notion that people have no right to
> find out something about their own bodies if the government
> thinks they might make a wrong decision based on the knowledge?
> Sounds like time to get out the tar and feathers, if that's the
> way our government thinks about the citizenry.
Amen, but that's been the notion for quite some time now. How nauseating that government bureaucrats are making the key decisions about our health, our bodies and our treatments by force. God only knows what innovations and new technologies these greedy power mongers have prevented from even being developed.
And yes of course it has nothing to do with public health. It's about political patronage and raw ugly power combined with horrible incentives, but packaged as "consumer protection" and "public safety regulations" to confuse the feeble-minded.
Oh for the good old days of the benevolent and relatively freedom-loving King George III.
If I pay a company to sequence my DNA and the company only supplies me with the results then how will insurance companies use this information against me?
I figure that if my DNA sequencing results flow back to a doctor's office I'm at higher risk of more people seeing my DNA sequence than if the results only come to me.
I wrote my response before reading yours. We agree completely.