Agency sent letter saying it was 'unable to identify' the kit was approved
Article Source: msnbc.com
from:msnbc.comWalgreens gene test on hold after FDA alert
Seeded on Wed May 12, 2010 9:12 PM EDT (msnbc.com)
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Sensible decision by Wallgreen's...more sensible still if they just gave up on the idea of enabling these 'flim-flam' artists altogether and left the product off the shelf permanently.
Save your money and get a deck of Tarot Cards...chances are they're more predictive than this test.
Walgreens needs a test to guard against rude cashiers/managers.
Who trusts anything backed by the FDA nowadays and who would waste their money? People, we are all gonna die - and it's likely going to be from an illness or side effect created by years of consuming the various foods, drugs, and other store shelf items the FDA has (ironically) approved for mass consumption/use.
You should see what some countries without regulatory agencies eat, drink and medicate with. Be thankful we have an FDA and that they mostly do their job. Nothing run by humans is perfect, and they often have their hands tied due to intense lobbying against certain regulations by interested industry groups, but without em, well, all you have to do is pick up a history book. I'd suggest first looking up why it's name Coca-Cola.
Nobody remembers the days before the FDA. The FDA saved us from Thalidomide babies and was developed in response to the quack medicine of the day. Radium serum anybody? From the old days when everyone thought "Radiation" was novel and thus worthy of eating by the teaspoon.
The days before the FDA? You mean when we didn't have a bunch of lame pencil-pushers regulating EVERYTHING as they need to justify their bloated salaries? Yes, we all know how Coca Cola got its' name; that info can be gleaned from a seventh grade education. Granted, you may have an eigth grade one, Capt Tripps.
No
I went to an evil,liberal college and got me's that official book learnin's...you on the other hand were obviously home schooled by people who spent much of their lives partaking of America's favorite soft drink's namesake.
There is definitely an issue with providing people information about their genetic make-up as it pertains to disease without genetic counseling to go along with the results. For example many people may not understand that even if you carry a gene for a specific disease that may only mean that you have a greater risk for the disease, not that you are automatically going to get it. I think the concern is that seeing a positive result for something like Huntington's could lead to people making rash decisions before they ever even have a symptom. Walgreen's is wise to wait on this one.
As I'm reading through peoples comments tonight, it seems that counseling needs to go along with results of any scientific study!
Not counseling with the results to a scientific study but counseling with results to a genetic test that tells a person if they have a life-threatening illness. Someone who finds out they have something like Huntington's might make a rash decision that should not be made when they have just received devastating news - counseling could help prevent that. You would not tell someone they have cancer then just walk away would you?
Sounds like someone knows someone who knows someone who might have been unfaithful to his spouse and thinks they might be eligible to be sacrificed by the media and is willing to do a favor for someone that knows someone that might be able to talk to someone that can relay a message to someone's wife and cover their ass for a little while longer or until his wife finds out and his mistress goes on Oprah. Maybe they might find out that Haliburton is actually BP's Daddy. That is an ugly baby! What we need is a Flucking test that can prove competency and conscience and line up the whole lot of us and empower the group that can get this boat out of Harm's Way.
If we could see the future, what would life be worth living? It's a journey to be unfolded carefully like an old treasure map. Look at it as you will, but I see it as that. Every turn and corner is an adventure. I sorta know I have a disposition towards most diseases, but who probably doesn't? You may be a perfect baby/human and then get hit by a car when your 12. That's life baby!
I'd like the right to decide whether or not to get such a kit. It's not poison, nothing is ingested. Seeing my DNA is more a glimpse at my past, than at my unwritten future. Should anything "come up", well, seems to me that if I had enough brains to be interested in seeing some of my DNA traits, then I'd have the sense to see a doctor if something seemed serious.
My grandmother, and her mother, lived to 90+, yet her daughter, my aunt, has had a double mastectomy, then yet another cancer - at 61 - but her father was adopted, we don't know that family history.
Genetic or environmental? Who knows - and who knows if this test kit would even note anything of interest. But if I want to plunk down twenty bucks and try to check it out, so what.
You can get that info anytime you want...ask for a referral to a genetics specialist.
And it would be much more expensive...
You get what you pay for....the info is useless in your hands.
I'm upset that they won't sell it. I was adopted and have absolutely NO information about my medical history. I have no idea what I am at risk for, and therefore cannot practice preventive measures. There are many people that can benefit from this as myself.
I hope they do offer it soon.
You can go see a doctor, and get actual, factual information and advice from a professional who knows your personal medical history.
If you have insurance anyway, which you will shortly one way or another.
If someone has twenty bucks to spend on the kit, and cares enough to want to check, then all the babysitters at the FDA maybe ought to let grownups decide for themselves.
Unfortunately, the data requires to be analyzed along with your medical history and other factors to even get close to being meaningful. 20 bucks buys you nothing. The test itself is 100's of dollars anyway. Might as well hire the required skills and knowledge to go along with the data.
and if old people want to invest in land in Florida, why should we stop them?
I think all the FDA is doing is making sure the companies product does what it claims to do, because that's what consumers will expect, and will be reacting from said assumption.
It's never been demonstrated just how reliable these kits are. Inquiring minds want to know.
I'm sure testing labs would also profit by selling this information to data base warehouses such as Choicepoint. Then it would be available for purchase by medical insurance companies, marketers, and potential employers. Just like your credit record already is for sale.
Say you tested positive for a propensity for some genetic disease or type of cancer, you could get a notice from your insurance company that your coverage does not apply to that condition. Nothing illegal about it. Results of your genetic testing would be treated as pre-existing conditions.
I would only take such a test if I could remain completely anonymous.
Thank goodness that was addressed in the new Healthcare Bill.
Surely it is anonymous.
FamilyTreedna dot com does genetic testing - not medical - for the Human Genome Project with National Geographic, and for people interested in genealogy - and it is over a hundred dollars, depending on how much testing is ordered. You get an id kit number and password.
This company is marketing direct via a pharmacy with just enough science mumbo-jumbo to con 'Joe Average' into laying out hundreds of dollars for a bunch of data he can't adequately use.
Ok so having done the wallgreens test. Joe makes a determination he is ill , or will be, takes this data to a GP. The GP looks strange at him as if to say, "you could have just asked me to organise for this to be done properly you know", charges Joe for the visit and refers to a genetics specialist. The specialist dismisses his test data knowing where it came from and reorders the test from a provider he can trust under standardised conditions and known methodologies. When the results are in, he will then counsel him off these trusted results in association with a full medical history being taken.
All that is acheived by getting this kit is another 400 odd dollars ...the proce of the test you he done.
This isn't an over the counter pregnancy test that can spit out a "you is-or-you aint" answer...seems that's a point missed by Wallgreen's and company pushing these tests to the shelves.
Leave lay genetic data to the Maury Povich show.
If you suspect you requires
Big Brother, mind your business! What the does the FDA have to do with a kit, that does less medical invasion then an auto test kit? What happened, you government people not getting a cut of the action? Screw off Big Brother!
I think it's the same reason we still don't have snake oil salesman,sometimes you have to protect people from themselves.
The manufacturer's have to first prove they can actually do what they claim, reliably, before selling something marketed as medically relevant.
If you had an adverse reaction to a testing kit or other product, you'd be yelling at Big Brother for NOT protecting you.
This is the typical story: the FDA is not protecting us, I wish it was for a change. It is protecting the medical profession and and the income of physicians. The message is that the consumer cannot handle the information these tests would provide. The truth is that it would put the power of knowledge into our hands where it belongs. It would provide essential information to alter our life styles according to the outcome of the test. The problem is that we don't necessary need a physician to do that. Another problem could be that we change our lifestyle without the use of pharmaceuticals. That would be a double loss and the FDA cannot allow it. It has been clear for a long time on which side the FDA stands. I hope that Walgreens will follow through and provide this genetic test to the public.
Not sure how the average consumer would use the information without talking to a doctor or healthcare professional. It's like people who self diagnose on the internet. Medical school doesn't last 10 years because they like going to class.
If people can buy Chia Pets and doggie Snugglies, then they ought to be able to buy other non-toxic "items". Maybe the test would get some people up off the couch and into their doctor's office for some help. One more nanny state annoyance.
How about being allowed to decide with my wallet?? article link - "With a $20 to $30 kit, customers will spit into a plastic vial to provide a DNA sample for analysis and ship the package to the company.
For $79, customers can get their DNA tested for how their bodies are likely to respond to 10 substances, including caffeine, cholesterol-lowering drugs called statins, the blood thinner warfarin and the breast cancer drug tamoxifen.
For $179, prospective parents can be tested to see whether they carry 23 genetic conditions, including the blood disorder beta thalassemia, diabetes and polycystic kidney disease. For the same price, they can be tested for their own risk for 23 conditions, including heart attack, high blood pressure, leukemia, lung cancer and multiple sclerosis.
For $249, they can get all of the tests." .... I'm not interested in all, at my age, but I am interested with people being able to choose.
Good decision by Walgreens Drug, bad product for Pathway Genomics. This DNA kit was going to use the most decisive emotion of humans, fear. This product was all about money, not diseases, illness or other health issues. The price for the results ranged from $79 - $249, which meant, for $79 Pathway would tell you have a cold, and for $249 a more serious illness that will cost you life, except for one thing, you may and may not get this illness. Everyone knows their family history when it comes to serious medical conditions. If your father and mother both have high cholesterol, there is a good bet you will have high cholesterol. If people use this kit to determine their likelihood of getting a serious disease or illness, they will worry for years needlessly, and that worry will do more harm than a disease or illness that you may never get. I surely hope people take care of themselves by eating properly and exercising, than getting a kit that will tell them their fortune.
Sensible decision by Wallgreen's... Well I amnot sure. Maybe its because some one won't get enough pay off.....
I agree with Garrick S. Call me paranoid, but I have seen the insurance companies try to make everything a pre-exitsting condition [even as a mistake on their part] just so they will have a reason to not cover or charge more for coverage and co-pays.
I would never take such a test. The FDA isn't as reliable and trustworthy as it used to be. Its just another way for people to make money all the way around. The pharmaceuticals results are so open ended and there are no guarantee's.
The reason the FDA doesn't want them to sell the kit is because it cuts out the middle man (doctor). Why would doctors want people to be able to do genetic testing affordably when normally, they would have to pay the doctor 10 grand for it?
Because it wouldn't be analyzed by those without the skills.
Well then, why don't we get the tests at Walgreens and then pay a doctor to analyze them? That way, it would cost much less.
How is the doctor the middle man here? The "middle man" represents someone not needed in the process, I'm not getting how doctor's are superfluous with regard to understanding the results and making real world decisions about the information.
And a real doctor would probably go by your symptoms, lifestyle, family history, etc, than use a genetic test anyway.
At the risk of sounding like an over the hill oldster, my earliest memories of Walgreen's was the mid 1940's...Walgreen's through the years, was a solid business...well respected and a gathering place for a wide spectrum of needs...then in recent years the reputation has undergone a gradual deterioration...the pharmacies no longer a comforting source of information and guidance...rude employees who erect barriers to communication and customer satisfaction...and now this effort to stimulate revenue generation with little adequate research or thought to the repercussions...I fear the time is on the horizon when Walgreen's will no longer exist...without a massive PR effort and restructuring of services, the competition is going to do them in...of course with the latest gaffe, it is entirely possible they will do themselves in!
Resurch what happened to the Havasupai Indians of The Grand Canyon in Arizona after they had a DNA test by the Arizona State Univ. to find out why they had such a high incidence of type 2 diabetes. Furhter testing was done without there permission in the name of science. The tribe sued and won but the dammage was done. Sandra Soo-Jin Lee, medical anthropologist at the Cenetr for Biomedical Ethics at Stanford University agrees that ther is the danger for uncontroled studies when your information is so out there.
a genetics test just looks at genetic markers, they are there or they aren't. it's not rocket science. it like renting a car diagnostic tool, you plug it in and it pumps out fault codes. you don't have to be a mechanic to understand the results. why would a intelligent person pay 10 grand for testing if you could get the same thing for $250? i am sure they have a lab that tests for amino acid markers and a staff trained to do it, simple stuff. last year I had a bladder infection and needed antibiotics. knowing this I went to the doctor. and asked for some. they said they needed to run some tests first. then they said it might be a kidney infection caused by a kidney stone. so they ordered a CAT scan. long story short no kidney stone it was a bladder infection i needed antibiotics and it cost me over $4000 dollars out of pocket. if in Mexico I could have went to the pharmacy and it would have cost me $20 bucks. I had a problem with mobility for months (certain days I could only walk 30 feet, or less before being in to much pain to move) saw 3 specialists and they concluded it was a pinched nerve and was going to require extensive testing, scans and a risky surgery to fix. But luckily I bought a new pair of shoes and have been fine ever since. Doctors are really not that qualified, it seems to be a big guessing game for them, I don't 100% trust them. I have almost never been helped by seeing a doctor, usually I leave still with no information and have to self diagnose anyways. just have less money in my pocket afterward.
oh and think about this if you spent 10 grand for genetics tests they would send to an outside lab maybe even the same lab to get the same results. let us decide on our own.
That's a frightening assertion. Who IS qualified, in your opinion then??
You make a very good point.
I wouldn't recommend doing genetic testing at home. One of the main reasons I wouldn't recommend it is what if something comes back positive? Getting a positive test for a disease, disorder or predisposition towards a disease can be psychologically devastating. Being with a professional that knows what next when delivered this news can be a huge relief.
I remember going through genetic testing with my youngest son. He was sick for the first two years of his life - and spent a lot of that time in the hospital with respiratory infections, extremely high fevers (like 106F), GI infections, and skin infections. They ended up doing testing on his immune system and for cystic fibrosis. His sweat test for CF came back border line, so they did the full genetic testing of him, myself and my ex-husband. Our son came back as having a primary immune deficiency and being a carrier of CF (both myself and my ex-husband are carriers also). Waiting for those results was nerve racking. However, having the geneticist, immunologist, and pulmonologist there to discuss the results made it a lot easier. Thankfully, he's only a carrier of CF, so no problems with that. I would not have wanted to get the results to this test at home - there is just too many questions, concerns and stress that comes with these diagnoses to do at home without trained professionals there. However, having a positive test on the primary immune deficiency came with a lot of questions - how can we keep him healthy and give him the best life possible were the main questions. Luckily, the immune deficiency he has is relatively minor - he has a IgG2, IgG4 and IgA deficiency. There is no clear genetic link for IgG subclass deficiencies, but there is a stronger genetic link for IgA deficiencies - so it's not something that would tested for in a home genetic kit.