Why Do You Need A Doctor's Note To Get A Genetic Test?
from the makes-no-sense dept
There have been a bunch of personal genetic testing services popping up over the past couple of years. One of the most well known is 23andMe, who got a PR lift for being founded by Sergey Brin's wife -- and also getting an investment from Google. Typically, the program lets people send in a cheek swab and receive back personal genetic info. These services are still in their early stages, but the few folks I know who have used 23andMe have found it to be an interesting learning process. However, now it's coming out that 23andMe and other personal genetic testing services may actually be breaking California law. California has sent a bunch of these firms cease-and-desist letters demanding they close up shop until certain conditions are met.Apparently any labs doing the tests need to get both state and federal certification and can only do tests based on a physician's recommendation. The state claims it sent the letters after receiving "multiple consumer complaints about the accuracy and costs of genetic testing advertised on the Internet." This seems quite questionable for a variety of reasons. First, if people have "complaints" about the costs... then the proper response is to simply not buy the test. I have complaints about the price of Ferraris, but I'm not going to complain to the state of California -- and I doubt that the state would send cease and desist letters to Ferrari dealers.
Secondly, it seems quite ridiculous to say that these sorts of tests can only be taken with permission from a physician. There seems no reason not to let those who are willing to pay the associated fees to get a personal genetic test without involving a physician at all. As we move more and more towards more personalized medicine, this problem is only going to come up more and more. Not all medical tests and treatments need to be done under a doctor's care -- and requiring it in all cases seems more like a way to protect physicians' fees rather than citizens' health.
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Filed Under: california, cease-and-desist, genetic tests
Companies: 23andme
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Hrmm
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Re: Hrmm
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Ultimate ID Theft
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Re: Ultimate ID Theft
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Hell, ask the average person what a 25% off sale means.
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Ok, I'll bite. Does it mean the price is 75 percent of what the original price was? So, if it was one dollar, now it is 75 cents (not figuring taxes in)? Or do I need a doctor to interpret it for me?
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I don't see how that's the lab's concern, or the government's. Perhaps the lab can ad value by providing (for additional cost?) a detailed explanation of the results (assuming this isn't already done). Or people should just consult a physician after the fact when they don't understand the results. What shouldn't happen is insisting the government coddle us because we might misinterpret something and can't be trusted to actively take care of ourselves.
After all, most women upon recieving a positive result on a pregnancy test subsequently consult a doctor for advice and council on what to do next. But they can manage the "recieving test results" fine on their own.
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empower us to receive, manage and own our own health information. it's that simple.
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Ethical Regulation
I'll add that the science of determining a person's risk factor for most diseases, or determining their ethnic background is still poorly developed. While DNA tests are quite accurate for matching crime scenes or paternity tests, the science of guessing a person's ethnic background or their risk for developing cancer is still very poorly developed. News headlines made a big deal out of the "BRCA-1" and "BRCA-2" genes that predict breast cancer, but the data came from a small group of Orthodox Jewish women. It is well known that the same disease can have completely different genetic origins in differing populations; there are many genes that cause hemophilia, for example.
Furthermore, these "genetic testing" companies are scamming rich people by telling them they are descended from Genghis Khan, that they are part (insert ethnic group), etc. when the science is dubious in the extreme. The data on ethnic distinctions in DNA is still very sparse, and there is a lot of overlap anyway.
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Re: Ethical Regulation
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Re: Re: Ethical Regulation
So if a genetic testing company told you that you have 2 years left to live because you have the genes for some deadly disease, would you prefer to pad the treasuries of companies that claim to cure the disease before it happens?
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Re: Ethical Regulation
So in essence the insurance companies are recieving inaccurate data on people they may or may not be insuring as well as the fact that these people decend from celebrities?
I think someone is reaching.
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Re: Re: Ethical Regulation
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Law
Dose this mean that all court ordered genetic testing is illegal in California, since those court orders come without a physician's recommendation? Is there a loophole that the California courts are using to circumvent this?
All in all it, dose seem stupid that I can't choose to get a genetic test with out the approval of a doctor; it's a test, not treatment.
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Traditionally...
When I transitioned through the Serology department, the first thing they taught me was "when a patient calls and asks about the results of the test(s) - you tell them to call their doctor - you never, ever, ever give results directly to a patient".
I asked why and the answer (which now seems obvious) is that you don't know the context in which the test was performed - you don't know if the patient wants a positive or negative result and you're not trained to tell a patient that (s)he is positive for a life-threatening disease, or that the couple who have been trying for 30 months to conceive don't want to hear that their pregnancy test result is negative. You can't always assume that what you think is good news is what the patient wants to hear.
If you take a cheek swab from your infant and send it on for DNA profiling, do you want a form letter printed from a computer that says "Your sample show a high probability of a crippling genetic condition and you will be lucky to live long enough for a second birthday"? Or would you rather have a doctor explain it to you and be there to answer the questions that you are no doubt going to have?
I don't necessarily agree that it needs to be a law that doctors have to be involved, but there are good reasons for wanting a doctor to be between you and the lab.
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Re: Traditionally...
Pretty much comes down to that in my book. The state has no right to stop this type of self knowledge, and there are plenty of valid reasons for getting this information into a person's possession.
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"The Genetic Information Nondiscrimination Act was signed into law Wednesday [May 21, 2008] by President Bush, after passing overwhelmingly in the House and Senate.
Described as the first major civil rights act of the 21st century, the law protects people from losing their jobs or their health insurance if genetic tests show they are at risk for cancer, heart disease or other illnesses."
-Chicago Sun-Times, May 22, 2008, by Monifa Thomas
We also know that the company didn't make up the data because it is sent directly to a lab at a company called Illumina in California that uses high-tech equipment to study the DNA sample and send the results to 23andme. Nice try though.
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"The Genetic Information Nondiscrimination Act was signed into law Wednesday [May 21, 2008] by President Bush, after passing overwhelmingly in the House and Senate....
We also know that the company didn't make up the data because it is sent directly to a lab at a company called Illumina in California that uses high-tech equipment to study the DNA sample and send the results to 23andme. Nice try though.
Just because a law is passed does not mean it is enforced. Which agency enforces this law? How do we know Illumina is not a participant in the scam? Should we have believed Enron when they claimed to manage California's electricity supply better than the government did?
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Probably the Executive, through law enforcement agencies commonly known as "police." Though if there's a dispute, I guess that could go to the "courts."
Or do you expect us to stand up a new government agency everytime we determine a new crime that could be committed? Hell, we already have mechanisms in place to punish other kinds of discrimination on other protected classes, that's not good enough for you?
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Or do you expect us to stand up a new government agency everytime we determine a new crime that could be committed? Hell, we already have mechanisms in place to punish other kinds of discrimination on other protected classes, that's not good enough for you?
Law enforcement agencies have specific mandates on which laws they enforce. There are plenty of crimes the FBI does not investigate, because they are not mandated to enforce them. Unless the genetic testing law was assigned to a specific agency, the law is useless.
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Interpretation
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Re: Interpretation
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Re: Interpretation
I think that it is critical one orders a genetic test under the guidance of a doctor at the least, perhaps a genetic counselor if one can be afforded. Risk factors and diseases are not black and white: there is a great deal of grey area, and even many "risk factors" are still poorly understood and are still in the research phases.
However, if someone wants to get a genetic test solo and does not decide to see a doctor about the results and misinterprets them...that's their own problem. The law shouldn't have to force people to make an intelligent choice.
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Re: Interpretation
For some reason everyone seems outraged that the government wants to try and protect them.
Aside from all the misdirected comments about the norm of getting orders for largely medical procedures.
Has anyone ever considered that this is a good thing? That by mandating government & medical oversight we are stopping companies from mandating genetic screening as part of the hiring process, or insurance companies from requiring it as part of the application process?
Can you imagine if genetic screening entered the free market? This is totally unlike drug testing or pregancy testing. Both of which are temporary personal choice conditions. Did some drugs in high school? Thats ok, just stay clean for a while and they won't show up on your record.
With genetic testing, your make-up never changes, one test and someone could potentially see your risk for all types of cancers or defects. Would you or even your kids or grandkids want to be discriminated against based on your genetic makeup? Because thats what you're asking for if you side with this entering the free market.
If you regulate it then companies can't touch it, and if they try then there are a lot of necks to wring if something bad does happen to the public.
To the comment on FDA approval.
I used to work for a pharmaceutical company. Trust me, "cures" and "experimental procedures" are thought up by marketing departments. R&D is literally mixing stuff together and testing it on rats to see what it does. If your uncle was dying of a disease and they didn't want to let him try an unapproved research medication it was in his best interest. Subjects dying of disease are a research protected population since they are so willing to try anything.
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Re: Re: Interpretation
Perhaps that's because a lot of people are sick and tired of the gov't "protecting" them from things they don't need to be protected from. Especially, when nearly every "protection" is really more about ensuring a monopoly for some special interest group.
Has anyone ever considered that this is a good thing? That by mandating government & medical oversight we are stopping companies from mandating genetic screening as part of the hiring process, or insurance companies from requiring it as part of the application process?
Wow. That's got absolutely nothing to do with this story. Both of the scenarios you describe are already covered by existing laws that have NOTHING to do with getting a personal genetic screening.
Can you imagine if genetic screening entered the free market?
Yes. I think it would be fantastic. Just read "The End of Medicine" to get a sense why.
With genetic testing, your make-up never changes, one test and someone could potentially see your risk for all types of cancers or defects. Would you or even your kids or grandkids want to be discriminated against based on your genetic makeup? Because thats what you're asking for if you side with this entering the free market.
You are being TOTALLY misleading. That can be taken care of (and is) by anti-discriminatory hiring laws. That has nothing to do with an individual getting a test for their own interest.
I used to work for a pharmaceutical company.
Ah, well that explains everything.
Forget what I said about "The End of Medicine." That'll make you go ballistic.
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No one denies that interpreting the results may not be straightforward -- but that doesn't mean it should be against the law for those who still want to get the results themselves to do so.
Those who are really concerned will still go to experts to help them understand the results.
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Why?
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Re: Why?
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From a law enforcement perspective...
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Re: From a law enforcement perspective...
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Re: Re: From a law enforcement perspective...
So would you want to pay thousands of dollars for "test results" that may have been fabricated by a random number generator, or got mixed up with somebody else in the lab? If you don't want the government to "hold your hand", then the private sector will happily take money out of your hand instead.
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Re: Re: Re: From a law enforcement perspective...
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When was the last time the government was concerned with your happiness? Im sure this comes down to dollars in some way. Someone needs that $75 copay to help retire the note on their boat.
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Re: Re: Re: Re: Re: From a law enforcement perspective...
Exactly why I want them involved as little as possible. Build roads, manage courts, keep the Commies at bay, and leave me alone.
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Consider cars for example, some are great and some are shit boxes. Thats why I look at consumer reports before I buy a car.
People feel that we need the government to tell us whats good and whats not, whats safe and whats not. Let the people make the choice. If there is a significant risk in the product, than the market can provide ample solutions without government involvement (i.e. Consumer Reports, Zagats, Underwriters Laboratories, etc)
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Re: Re: Re: Re: From a law enforcement perspective...
This is similar to that. The government is not limiting who you can take the test from. But they are providing a safeguard against a number of things.
This law is simply protecting the average citizen. Much like how perscription drugs require diagnosis by a skilled physician and a further perscription to prevent abuse. If this sort of cautiousness is unwarranted, the law will be repealed, or ignored. But its better to have some safeguards, if flawed, then none at all.
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Re: Re: Re: Re: Re: From a law enforcement perspective...
I fail to understand what the government is safeguarding against in this case. Privacy issues, etc. have been cited in these comments. Do organizations with strict government oversight not have privacy issues? I think not. The industry could be regulated to death and still have all the problems described here.
As to your example, I would argue that the governments involvement in the pharmaceutical industry has severely limited our ability to innovate. As a case in point, an uncle of mine just died from a disease for which there is no current (recognized by FDA) treatment. There are, however, experimental treatments which have not yet received FDA approval. He was going to die very shortly anyway, and yet you will have me believe that the FDA's barring him from these potentially life saving treatments somehow was protecting him?
I will reiterate: Let people decide for themselves. It is not the governments place to protect us from ourselves, nor should it be.
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Re: Re: Re: Re: Re: From a law enforcement perspective...
Perscription drugs are another beat entirely. In that case we're talking treatment, and unwarrented or erroneous treatment can be hazardous: most people DON'T know enough to treat themselves. DNA screening is just a test, though, and as noted most people are quite capabile of recieving (if not necessarily interpretting or acting upon) test results. I shouldn't need a doctor to tell me it's OK to get a test done.
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Why is this any different than drug testing?
There does not seem to be a uniform concern for the consumer/patient even though the same labs can process both types of tests.
Perhaps the state of California should also require a doctor's permission for drug testing as well.
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Whether or not the consumer understands is irrelevant
If the book happens to be filled with DNA sequences and information about your single nucleotide polymorphisms, that makes no difference.
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Unfortuanately, current body of law does not reflect the idea that you own your body. For example, if a patentable drug is directly derived from something inside your biochemistry, you have no claim to it whatsoever. Only the company that "developed" it has claim.
Amazing but true.
Back to the point: My DNA, whether in molecular form or printout form. Mine. Period. Paying someone to translate the data form one format to another should absolutely not require the "permission" from an MD any more than paying a company to translate the data on an old floppy to a modern USB key should require the "permission" of your nearest certified IT expert. My data.
If we don't begin to fight these laws NOW, the ownership of our own bodies will continue to be taken from us.
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Costs
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What is there to know?
If you get a whole genome from Mumbai or San Fran......"What is there to know?" What possible information could you glean from just a mere genome...which right now isn't even a true genome. Nor does it represent the entire book of you....in fact it isn't even a chapter in the book....so to all the "self-knowledgers" out there.....try and trust wikipedia or google on this....most of that information is faulty....and you likely will not be able to read it...if you can....it will be out of date in 6 months to 1 year....assuming it is currently correct information...
So I ask.....Now you have your "pseudo" genome.....
"What is there to know?"
-Steve
www.thegenesherpa.blogspot.com
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Money
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