Government Protecting Us From Info About Our Bodies!
John Tierney writes in The New York Times of New York's ban on the direct sale of DNA tests to consumers:
What if the would-be guardians of the public overestimated the demand for their supervisory services?In two separate studies of genetic tests, researchers have found that people are not exactly desperate to be protected from information about their own bodies. Most people say they'll pay for genetic tests even if the predictions are sometimes wrong, and most people don't seem to be traumatized even when they receive bad news.
"Up until now there's been lots of speculation and what I'd call fear-mongering about the impact of these tests, but now we have data," says Dr. Eric Topol, the senior author of a report published last week in The New England Journal of Medicine. "We saw no evidence of anxiety or distress induced by the tests."
He and colleagues at the Scripps Translational Science Institute followed more than 2,000 people who had a genomewide scan by the Navigenics company. After providing saliva, they were given estimates of their genetic risk for more than 20 different conditions, including obesity, diabetes, rheumatoid arthritis, several forms of cancer, multiple sclerosis and Alzheimer's. About six months after getting the test results, delivered in a 90-page report, the typical person's level of psychological anxiety was no higher than it had been before taking the test.
Although they were offered sessions, at no cost, with genetic counselors who could interpret the results and allay their anxieties, only 10 percent of the people bothered to take advantage of the opportunity. They apparently didn't feel overwhelmed by the information, and it didn't seem to cause much rash behavior, either.
In fact, the researchers were surprised to see how little effect it had. While about a quarter of the people discussed the results with their personal physicians, they generally did not change their diets or their exercise habits even when they'd been told these steps might lower some of their risks.
Government-forced fast food labeling had a similar effect on the public's behavior: None.
Just as they're making health care more expensive, they're making it less possible for us to help ourselves at a reduced price.
There's a difference between fast food labeling and prohibiting DNA
testing. If the test results are inaccurate or merely quackery,
then this falls under fraud prevention. Of course, for consistency,
New York should also outlaw fortune telling and astrology.
Ron at January 19, 2011 3:49 AM
So much for "knowledge is power" I guess.
Sabrina at January 19, 2011 7:21 AM
From Amy's linked article, this - for me - is the key argument:
“It seems like a no-brainer,” Dr. Silver says, “that any competent adult should be free to purchase an analysis of their own DNA as long as they have been informed in advance of what could potentially be revealed in the analysis. You should have access to information about your own genome without a permission slip from your doctor.”
Scams & quackery already come under fraud, as Ron points out. I recall a kerfuffle about some bogus "DNA" diagnosis-by-mail on the basis of analyzing a single hair from your head a while back!
Jody Tresidder at January 19, 2011 8:12 AM
Right on with the quote, Jody.
Amy Alkon at January 19, 2011 8:32 AM
I could just have my daughter send it in from her address. Not only is this ban stupid, it is laughably easy to circumvent.
I propose the state motto change to excrement from excelsior. It's what our legislators do.
MarkD at January 19, 2011 9:46 AM
I took a course in medical billing and coding over the summer (and am certified, having gotten 93% on thte national test), and I remember the instructor saying that once the new health care system was in place, that we (everyone, supposedly) would be able to access our own health records online. I asked if that included doctors' diagnoses and notes on individual cases, and she had no answer. She said something along the lines of "I'll look into it" but she never got back to me on that. I mean, if I asked my doctor for all of my records, she'd have to give them to me, right? They don't have the right to withhold your own health records from you. Their YOURS.
Flynne at January 19, 2011 10:28 AM
OMG my spelling is ATROCIOUS today. THEY'RE not their. And there's only one 't' in 'the'. Egads.
o.O
Flynne at January 19, 2011 10:38 AM
Well, try to walk out with your own MRI shots. I bet you get opposition from the imaging center staff.
Radwaste at January 19, 2011 2:46 PM
My problem is when the government -- fed or state -- puts someone between you and your choice of how you want to handle your medical care.
Notice the Life Line Screening terms for Texas. I can't say that I want a safe, non-invasive ultrasound and EEG without having a doctor "prescribe" it. Also the results are withheld from me -- the consumer who paid -- without seeing a doctor.
Doctors may be well trained professionals, but it is my body and my health.
Jim P. at January 19, 2011 2:58 PM
Radwaste: done that. They were completely willing, but let me know
that the data were in electronic form, and interpretation would need
the appropriate software.
As far as access to medical records go, it used to be their
property, not yours. HIPAA changed that. You now have an explicit
right to view your records (with some specific exceptions).
http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/healthit/eaccess.pdf
Ron at January 19, 2011 3:03 PM
Interesting. I looked up the date that HIPAA went into effect. I tried to get records after the date that it was passed, but before it was enforced in hospitals.
I had to subpoena my medical records. They had 6 months to turn them over. They did it on the very last day that they could and charged me 50 cents per page. It cost over $50.00 (almost 20 years ago.)
Perhaps things have changed, but it sure seemed like the hospital was doing everything that it could to prevent me from getting MY records.
Jen at January 19, 2011 5:20 PM
I know from my brother's experience that doctors and medical staff do not have to reveal their "personnel" notes unless they make their notes part of the medical record. I used the quotes because I don't what that really means.
In the particular case my ex-sister-in-law wanted to view the notes taken by their kids' doctor and the judge said no, the doctor only had to turn over the report and not the notes used to write the report (which had become part of the kids medical records).
The Former Banker at January 19, 2011 5:45 PM
...that doctors and medical staff do not have to reveal their "personnel" notes unless they make their notes part of the medical record.
What that means is they believe the patient is lying -- or the results are inconsistent with the tests. So they don't put in notes that are annotated by the doctor/staff that is inconsistent with what they can prove or will effect their payment. This is the same as work product for lawyers, or notes for police.
Ninety percent of the time (probably plus) they get it right that it is irrelevant for the case.
The problem is when a doctor gets it wrong -- they kill someone.
Jim P. at January 19, 2011 7:49 PM
I think the point is being missed. This is an excerpt from a recent article about this type of testing (you can find it here http://tinyurl.com/466h92k ):
The US Government Accountability Office (GAO) recently released the results of an investigation into 15 companies offering DTC genetic testing. And it raised some serious questions about the accuracy and validity of information currently available to consumers. The GAO purchased ten tests from four companies, and sent duplicate samples to each company, changing the demographic information each time. The results were alarming:
GAO’s fictitious consumers received test results that are misleading and of little or no practical use. For example, GAO’s donors often received disease risk predictions that varied across the four companies, indicating that identical DNA samples yield contradictory results. One donor was told that he was at below-average, average, and above-average risk for prostate cancer and hypertension.
Although the experts GAO spoke with believe that these tests show promise for the future, they agreed that consumers should not rely on any of the results at this time. As one expert said, “the fact that different companies, using the same samples, predict different directions of risk is telling and is important. It shows that we are nowhere near really being able to interpret [such tests].” GAO also found 10 egregious examples of deceptive marketing, including claims made by four companies that a consumer’s DNA could be used to create personalized supplement to cure diseases. Two of these companies further stated that their supplements could “repair damaged DNA” or cure disease, even though experts confirmed there is no scientific basis for such claims. One company representative even fraudulently used endorsements from high-profile athletes to convince GAO’s fictitious consumer to purchase such supplements. Two other companies asserted that they could predict in which sports children would excel based on DNA analysis, claims that an expert characterized as “complete garbage.” Further, two companies told GAO’s fictitious consumer that she could secretly test her fiance’s DNA to “surprise” him with test results–though this practice is restricted in 33 states. Perhaps most disturbing, one company told a donor that an above average risk prediction for breast cancer meant she was “in the high risk of pretty much getting” the disease, a statement that experts found to be “horrifying” because it implies the test is diagnostic.
Rhia at January 20, 2011 12:38 AM
Rhia,
Great link.
The article states: [The GAO] .."raised some serious questions about the accuracy and validity of information currently available to consumers."
Leaving aside the ancestry/paternity-related reasons consumers might buy a DNA testing kit (i.e. non-medical curiosity), I generally agree there is room for improvement in the way the (now) mushrooming testing companies make any claims at all regarding the immediate medical value of their kits to specific individuals.
While I am 100% in favor of an individual's right to their personal genome information, I also 100% support an individual's right to sue for damages on the basis of any company making fraudulent claims about its product.
Also from the article: "Although the experts GAO spoke with believe that these tests show promise for the future, they agreed that consumers should not rely on any of the results at this time."
One of the leading DNA testing companies - 23andme, for example, are careful to make the same point.
The unwary consumer might think this firm's sales pitch: "With a simple saliva sample we'll help you gain insight into your traits, from baldness to muscle performance. Discover risk factors for 94 diseases..." promises a personal diagnosis - but, if pay attention, it does not!
And, of course, 23andme's small print goes on to explain: "In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider."
In other words, read the small print!
And if a company actually says "buy our kit & save your life!" or "we guarantee you can find out if your kid is a genius/gay/sports star" then sue the bastards!
(I have no connection to 23andme! It's just the one company I've heard about...)
Jody Tresidder at January 20, 2011 11:08 AM
@Rhia - So prosecute them for the out-and-out lies, and possibly make them put disclaimers on the results. Don't just restrict them to doctors only - you can't overmedicate yourself with a test result. You might do it as a REACTION to your test result, but the test itself does not do any bodily harm.
WayneB at January 20, 2011 11:42 AM
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