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Pathway Genomics is looking to sell a variety of gene tests to the public via retailer Walgreens. The FDA may block sales, though.  (Source: Pathway Genomics)
Tests are going to be sold at 6,000 of Walgreens' 7,500 stores

Want to know if you will get breast cancer, Alzheimer’s disease, become obese, or suffer from a range of other maladies?  It's all in your genes.  

Currently you would have to go to doctors to test for genetic abnormalities that could lead to various illnesses.  An enterprising San Diego startup called Pathway Genomics has compiled a variety of these tests, though, and is about to start selling them at retail giant Walgreen.

FDA spokeswoman Karen Riley was surprised by the news and said that the company has not yet received approval for the devices and must first get approved.  Approval would involve a lengthy and expensive process of submitting evidence of the device's efficacy and could shelve the retail plans for years.  However, if the company does not comply, Riley warns that the FDA may order the devices pulled from Walgreens' store shelves.

Gene testing has to date exclusively been conducted in the medical setting.  The new Walgreen test, though, allows buyers to take a saliva sample and then send it back to the lab for analysis.  The company say that the results can help people make informed medical decisions.

The kits are set to go on sale at 6,000 of Walgreens' 7,500 stores.  Individual gene tests will retail between $19.99 and $30.  Combo tests are also available such as the drug-response test for $79, the "pre-pregnancy planning" test for $179, and the health condition test for $179.  All three of the combo tests are available for $249.

FDA's Riley warns, "The claims have limitations based on existing science, and consumers should not be making important medical and lifestyle decisions based on these tests without first consulting a health-care professional."

Jim Plante, CEO of Pathway Genomics refutes that his company has done anything wrong, stating, "There are people who need or want to know more about their genetic makeup, and we recognize that, for some, genetic reports are becoming a more important component in managing their personal health care.  The value of knowing how genes play a role in our personal lives, and potentially the lives of our children, is critical for making well-informed health and wellness decisions."

Ed MacBean, vice president of product development for the company says that his firm will "be happy to share with the FDA any data that is requested", but that, "We’re still going to sell the kits at Walgreens because at this point, we're not aware of any reason we are unable to."

The FDA according to a report in 
The Sun Times may also be considering action against online retailers of the test kits.  While Walgreens is the first brick-and-mortar retailer to offer the kits, they've been available previously online.



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This article is over a month old, voting and posting comments is disabled

We're from the government...we're here to help you.
By porkpie on 5/13/10, Rating: 0
By ttowntom on 5/13/2010 10:15:01 AM , Rating: 1
quote:
There goes our wonderful nanny state again, protecting us from the dangers of unrestricted genetic tests.
I'd love the hear the reasons from whoever voted that down. Why does the government think it has the right to tell us what tests we can and can't take? Whatever happened to freedom?


By perspicacity on 5/13/2010 10:56:28 AM , Rating: 5
Anything that defines itself as a medical device or a medical procedure has to get approval from the FDA. That even includes things like pregnancy tests too.

I think this has less to do with obstructing freedom and more to do with protecting people from a snakeoil salesman.

When you go to the drug store to buy something that claims to stop your cough, dry up your nose, reduce your headache... all without killing you... it's because the FDA checked it out first.

Believe it or not... if allowed to, there are companies out there that would gladly take your money and give you a "genetic report" that's completely bogus.


By XZerg on 5/13/2010 11:20:22 AM , Rating: 4
Just a note: Although this, FDA, does not stop companies from selling products that barely do any good or relabeling the same drug and selling as a cure for another illness too with a higher price.

I agree that FDA is needed and is a good way to prevent snake-oil products or even damaging products from cheating consumers out of money or health. Sometimes it is better to be late than getting it early and being screwed for rest of the life.


By AEvangel on 5/13/2010 11:42:58 AM , Rating: 3
quote:
I agree that FDA is needed and is a good way to prevent snake-oil products or even damaging products from cheating consumers out of money or health. Sometimes it is better to be late than getting it early and being screwed for rest of the life.


You must not watch TV and the tons of Attorney's who have ads asking people to call who have used FDA approved drugs and then found out they have all these side effects.

Please the FDA is a joke and has been for years. The idea that they really care or do anything to protect us is laughable at best. The only thing that really protects us from your so called "Snake oil Salesmen" is the fear of a law suits by a damaged or mislead public.


By AssBall on 5/13/2010 12:32:16 PM , Rating: 3
The FDA is a joke. It takes them several years and millions of dollars to apporve even the most well researched and simplist drugs. Bureaucratic B.S.


By AEvangel on 5/13/2010 12:49:58 PM , Rating: 3
Or they Ban they ban medicine or medical procedures due to political pressure and not because it poses any actual health risk.


By Proxes on 5/13/2010 1:27:59 PM , Rating: 3
Or they want to ban the electronic cigarettes because they have chemicals that aren't good for you.

Orly? Why don't you ban real cigarettes then?


By digitalreflex on 5/13/2010 3:04:09 PM , Rating: 3
quote:
Orly? Why don't you ban real cigarettes then?

because of the $$$ they bring in


By BansheeX on 5/13/2010 10:52:31 PM , Rating: 2
Perfect example is Stevia. Not a medicine, but a natural (patentless) no-calorie sweetener banned in the 80s because domestic companies with patents on chemicals like aspartame stood to lose billions. There were actually FDA members who left to become executives at these companies after the fact. Really crooked stuff, especially when you think about all the health issues aspartame has caused. Aspartame remains the all-time number 1 complaint generator for FDA approved food items.


By clovell on 5/13/2010 5:16:34 PM , Rating: 3
Clinical effects of even the most simple compounds are still very complex and take a lot of time to research. Review of New Drug Applications typically takes 10 months. The rest of the development process is spent collecting necessary data and performing experiments by each company. This is the part that takes years, more often than not.


By clovell on 5/13/2010 5:12:38 PM , Rating: 2
The FDA does a lot of good work, dude. I can base this on more than watching daytime TV ads. Lawsuits didn't stop Merck & Vioxx; the FDA did.

Nice try, though.


By Reclaimer77 on 5/13/2010 5:17:01 PM , Rating: 1
Umm but the FDA also approved the drugs in the first place. Stopping bad drugs BEFORE they get to the consumer is their job, right?


By clovell on 5/13/2010 5:22:25 PM , Rating: 3
Yes, it is. Unfortunately they screw up sometimes, but there's a lot more stuff that they catch than stuff that gets through, at least in terms of pharmaceuticals. As for Vioxx, a lot of that stuff was covered up / omitted and not reported to the agency.

They're far from perfect, but they still do a service to the citizens of this country and are far from the waste of breath & money that some folks seem to regard them as.


By dagamer34 on 5/14/2010 12:10:26 AM , Rating: 3
Some drugs don't show their side effects in any statistically significant way until it's out on the market. If you wanted to have a drug that had NO side effects, well... it just hasn't been invented yet (and almost certainly never will).

As much as people want to bash on the FDA, the fact that you don't have widespread pandemonium from people taking their meds means they are doing their job. Believe me, it would be MUCH worse if they weren't around. Don't take what you have for granted. That's the simplest mistake any person can make about anything.


By tastyratz on 5/14/2010 11:08:23 AM , Rating: 2
yup... prettymuch.
Cant have your cake and eat it too. People bitch about long term side effects then bitch about how long it takes to get a drug to market through all the red tape. Well the red tape is there for a reason and they should have to take the long hard road.

It is completely impossible to predetermine long term and many significant side effects not experienced in large pilot groups while keeping modern medicine unrestricted. Its a balance, and I think in general the FDA does it pretty well. Every once in awhile unforeseen circumstances beyond reasonable and thorough testing arise and eventually get squelched... but you cant see it all.

Anytime you have a problem with corruption its large government and man that's the problem, not the agency. No matter where you go you will find someone who will turn a blind eye with a greased pocket. Drug companies are big business.


By AEvangel on 5/14/2010 3:39:38 PM , Rating: 1
quote:
The FDA does a lot of good work, dude. I can base this on more than watching daytime TV ads. Lawsuits didn't stop Merck & Vioxx; the FDA did.


quote:
"In 2005, advisory panels in both the U.S. and Canada encouraged the return of rofecoxib to the market, stating that rofecoxib's benefits outweighed the risks for some patients. The FDA advisory panel voted 17-15 to allow the drug to return to the market despite being found to increase heart risk."


http://en.wikipedia.org/wiki/Rofecoxib#Withdrawal

The below article was written in 2004.

quote:
"Merck & Co.'s arthritis drug Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths before it was pulled from the market last week, the Wall Street Journal reported Wednesday, citing an unreleased study by government regulators."


http://www.msnbc.msn.com/id/6192603/

Yeah allot of good they did they not allowed the drug to be re-released but kept the study that showed it was killing people unreleased from the public.

Your going to need a better example of how the FDA is helping us cause Vioxx is a prime example of how it part of the same huge corrupt Fascist system that exist all over Washington.


By Staples on 5/14/2010 11:48:47 AM , Rating: 2
I'd rather have the FDA than nothing.
And I am worried that you believe these ambulance chaser commercials on TV. Must have never hear of frivolous lawsuits.


By Seemonkeyscanfly on 5/13/2010 11:28:46 AM , Rating: 2
Yea... but until then I want to invest into this company... I bet they sell a ton of these kits. Then in about a years or two time I will sell, because someone is going to come down with cancer after one of these kits indicates you will be cancer free. Even if they have a disclosure the legal action will happen and it will cost a lot of money.

I'm also interested in how a "pre-pregnancy" test works? What you pee on a stick and it say in blue writing on the stick, "yes if you have sex at a future time there is a chance you can become pregnant. Unprotected sex increase these chances."

Maybe we need more snake oil salesman to either weed out the knuckleheads or hopefully make people start thinking more and deeper about what they are hearing and seeing.


By clovell on 5/13/2010 5:19:32 PM , Rating: 2
> Maybe we need more snake oil salesman to either weed out the knuckleheads or hopefully make people start thinking more and deeper about what they are hearing and seeing.

That's a stupid idea. Read some Upton Sinclair.


By Seemonkeyscanfly on 5/13/2010 6:44:56 PM , Rating: 2
No it's not stupid, it's real life. Upton Sinclair was a Socialist. Socialist tend to wear out of focused rose colored glasses.

Using some quotes from Wikipedia:

http://en.wikipedia.org/wiki/Upton_Sinclair
Quote Wiki: "In his book The Jungle, Sinclair wrote about the inhumane conditions wage earners experience because of unregulated capitalism. Ironically, he began writing this novel on Christmas. His purpose was to expose the truth behind the unregulated industry of the day, including the poor treatment of immigrant workers, the poverty they lived in, the unsafe working conditions, and their job insecurity, besides their low wages. Sinclair wrote that, in capitalism, the wealthy are in control, and something needs to be done about it. He was the founder of the End Poverty in California (EPIC) movement.[11]"

He is wrong, in capitalism the creative and smart are in control.. (it's why a teenage single mother's child could grow up to be a billionaire... Do not believe go ask Oprah Winfrey). Yes, having money does not hurt, and it is good to have something over seeing areas like safety and give a voice to the little man. However, if he were alive today and I was able to talk to him. I would first tell him to look into a mirror and remind him that he was a poor man's son, yet he was very wealthy... If he was correct he should be poor because he was not born wealthy with his parent in control, because the "wealthy are in control in capitalism." However, his Dad was poor and his grandparent well off... So he saw the difference between the two life styles and he at one point in his life said, I'm not going to live the life of a poor man. Being he lived in a capitalistic society he could make something of himself without the aid of a rich person controlling his life and events around him.

quote Wiki:"His father was a liquor salesman whose alcoholism shadowed his son's childhood. Sinclair had wealthy grandparents with whom he often stayed. This gave him insight into how both the rich and the poor lived during the late nineteenth century."

So to that I say, maybe we need to wake some people up in this country... The government has or is giving too much protection for our own good. We need more people deciding for themselves that: "I'm not going to be poor, I'm not going to believe everything I'm told, I'm not going to be told how to live my life, I'm not going to be a servant to my government but they to me, and so on." Right now we have too many followers and no leaders. Maybe what makes for good leaders is people being burned or harmed from time to time.


By bigdawg1988 on 5/13/2010 9:47:06 PM , Rating: 2
I'm also interested in how a "pre-pregnancy" test works?

It is not a test to see if you can become pregnant, it is a test to see if you may carry any harmful genetic traits that could be passed down, like sickle-cell, hodgkins, etc.
Probably requires both partners to be accurate though.


By tmouse on 5/14/2010 8:56:44 AM , Rating: 2
Actually I think there say they are testing for potential miscarriages since they offer other specific "tests" for the diseases you mentioned.


By therealnickdanger on 5/13/2010 11:39:53 AM , Rating: 4
The FDA used to do its job and do it well, but now it's just one more bloated government entity run by lobbyists and supposedly "ex" corporate lawyers aiding the expansion of legal power and patent dominance of their former employers.

As I see it, there are already 1,000 commercials per day about "HD Eagle Eye Sunglasses" that improve vision, "Magentic Healing Bracelets" that improve your golf swing (and your entire life), "Fat-busting Supplements" that make you skinny (only if you are extremely overweight), "pills that make that certain part of the male body bigger", etc. There are tons of products out there designed and marketed to do things that they simply do not do, despite the testimonials and touted sales numbers. (Although it is comforting to know that 5 billion worthless capsules of PEN-15 Club GrowthMaxx+ have been sold to countless idiots.)

Here's a DNA test that may or may not have any more credibility than a BMI test... what does the FDA care? Thanks to Sen. Hatch and his pals, vitamin supplements are no longer regulated, so why should millions of tons of ingested chemicals be allowed to proliferate while a benign test is blocked? Are they truly protecting the interests of consumers in this case? Or are they simply trying to keep these tests in the government-only-certified medical arena at the behest of AMA lobbyists?

This test could be bogus, but the FDA is almost assuredly bogus. In either case, the FDA should probably stick to preventing more embarrassing E. coli outbreaks.

One more thing: the article is wrong, it's not Wal-Mart, it's Walgreens.


By RivuxGamma on 5/13/2010 5:28:22 PM , Rating: 2
The FDA is a mixed blessing. They allowed Fen-phen to be on the market until people's heart valves started going out. They also don't do anything about potentiall dangerous vitamin or herbal supplements.


By Connoisseur on 5/13/2010 11:16:29 AM , Rating: 3
Man I love how people here really seem to hate the FDA. If it weren't for the FDA, we'd have the quality control of China.

It sounds like the big concerns about these genetic tests are that the company hasn't proven that they aren't BSing the consumer. The fear is that a consumer will make a bad decision based on incorrect info without consulting a physician. Based on the intelligence of the average shopper, I wouldn't downplay it.


By Connoisseur on 5/13/2010 12:14:54 PM , Rating: 3
That's assuming the consumer is aware that a product is killing or damaging them. If it weren't for a regulating agency, what incentive would a company have to perform long term testing? What incentive would they have to list potential side effects?

It's easy to say that lawsuits and consumer sentiment would make the companies self-regulate but this isn't always the case. Oftentimes, there are many casualties over a long period of time before someone starts taking notice. Just look at phen-phen. I understand the irony that this drug was approved by the FDA as were many other harmful foods/drugs. I'm not saying the FDA is perfect (far from it) but at least there's ONE regulating body which demands a MINIMUM level of testing and quality.

As for those Chinese products you mentioned. They have to go through regulatory approval by the FDA as well. If they didn't, what motivation would they have to ensure that they meet minimum safety requirements?


By AEvangel on 5/13/2010 1:11:17 PM , Rating: 1
quote:
That's assuming the consumer is aware that a product is killing or damaging them. If it weren't for a regulating agency, what incentive would a company have to perform long term testing? What incentive would they have to list potential side effects?


What incentive do they have now...Like I said their are tons of drugs out their right now that have side effects and that are killing the people taking them. That is why all day long I see commercials on TV for some ambulance chasing attorney wanting to get your case for a drug you took that was FDA approved that has somehow hurt you.

The real problem with the FDA like most Federal agency is the curroption. Almost every single one of these Big Pharma companies has former employees on the FDA testing boards that help smooth the way for their drugs through the process.

I would rather see independent testing agencies rather then ones controlled and mandated by the government, because what happens when the FDA screws up, which they do quite often. NOTHING, no one gets fired no one gets in trouble. The congress has meetings and talks a good game, but no real reform or changes are made. Also the courts wont let you sue or or hold anyone their criminally responsible where you would through independent agencies.

The more people realize that Big Govt is not the answer for all are woes the better and safer this country will become.


By Connoisseur on 5/13/2010 12:14:58 PM , Rating: 3
That's assuming the consumer is aware that a product is killing or damaging them. If it weren't for a regulating agency, what incentive would a company have to perform long term testing? What incentive would they have to list potential side effects?

It's easy to say that lawsuits and consumer sentiment would make the companies self-regulate but this isn't always the case. Oftentimes, there are many casualties over a long period of time before someone starts taking notice. Just look at phen-phen. I understand the irony that this drug was approved by the FDA as were many other harmful foods/drugs. I'm not saying the FDA is perfect (far from it) but at least there's ONE regulating body which demands a MINIMUM level of testing and quality.

As for those Chinese products you mentioned. They have to go through regulatory approval by the FDA as well. If they didn't, what motivation would they have to ensure that they meet minimum safety requirements?


By chick0n on 5/13/2010 12:11:12 PM , Rating: 1
You get freedom as long as it does not damage their income/profit/share of pies.

They dont like this because they did not pay FDA ... err I mean they didn't go thru FDA's "test"

Welcome to socialism.


By clovell on 5/13/2010 5:10:30 PM , Rating: 2
Freedom? Freedom to sell a 'diagnostic test' without meeting any burden of proof required to show its accuracy & specificity?

You think that's characteristic of a 'nanny-state'? Let me ask you - and you, as well, porkpie - how much do you know about genetic sequencing and testing? How about its relation to Alzheimer's Disease? Huntington's? How about incidence, prevalence, stability, and good manufacturing processes?

Now, take that and extrapolate what the average consumer probably knows about that stuff - because I know you're both intelligent. Diagnostic products fall under the purview and charter of the FDA. This is exactly their job.

I can't imagine the amount of hell that would ensue if insurance companies were able to start jacking up rates or denying coverage based on results from these kits or any toher unvalidated test.

Every company that develops diagnostic equipment knows the the development cycle. It's been in place for decades. Where was the 'nanny-state' FDA during the 80s & 90s? Where was it ~10 years ago during the Vioxx debacle? I guess my mindset just isn't THAT Libertarian, because I don't see a problem here at all.


By xmichaelx on 5/13/2010 7:00:16 PM , Rating: 1
quote:
I'd love the hear the reasons from whoever voted that down.

I agree with porkpie, but I voted the comment down because it doesn't add anything to the conversation, and just sounds like whining.

quote:
Why does the government think it has the right to tell us what tests we can and can't take? Whatever happened to freedom?

The first question is a good one, and could lead to thoughtful, reasoned, and valuable discussion. The second sounds like privileged whining, not unlike porkpie's original comment.

Hope this helped.


By tmouse on 5/14/2010 8:51:56 AM , Rating: 2
Sorry but you did not really vote it down. Once you post your votes do not count.


By MozeeToby on 5/14/2010 10:41:50 AM , Rating: 3
Never heard of Thalidomide? It was an anti-nausea drug marketed to pregnant women throughout Europe that caused around ten of thousand birth defects. In the US, there were only a few dozen cases. Why? Because the drug never made it through FDA testing.

There is simply no way for the average person to know if a drug is safe, especially in the long term. In this case it took three years for coordinated research to determine the cause of the defects and that's for something that only takes nine months to manifest, imagine if the incubation period for problems was 5 years.


By MrBlastman on 5/13/2010 10:17:45 AM , Rating: 2
I don't quite see the harm in allowing Walmart to sell these kits. As long as the tests are legitimate and provide accurate results, or, at least a disclaimer on the efficacy of them, why not let them sell the kits?

If anything, making genomic tests more readily available to the public can be a very good thing when people are assessing their lifestyle and future prospects, or, even more importantly, trying to make an informed decision as to whether they should consider breeding or not.

Sure, there could be imposter tests out there that are snake-oil, but, when was the last time you went to a store and _did not_ see something that was snake oil? I see it all the time, and the government does nothing to prevent it.

In this case here, people could consult a physician for further advice after they receive their test results. It might not be a perfect or flawless model, but at least this is a step towards making it easier for all of us to know more about ourselves.


By ussfletcher on 5/13/2010 10:35:35 AM , Rating: 3
It is Walgreen's Pharmacy selling the tests, not Walmart. The writer is clearly baffled by the similar names.


By perspicacity on 5/13/2010 11:03:05 AM , Rating: 2
How do you think that happens where you can trust what you read on labels when you go into the drug store?

It's because the FDA reviewed it first.


By MrBlastman on 5/13/2010 12:22:42 PM , Rating: 2
Just because the FDA reviews something doesn't mean you can trust it, nor does it mean it won't hurt you.

Don't believe me? Just look at Vioxx and the massive settlement that followed after it was determined that Merck's drug was causing people that took it to have heart attacks when they otherwise would not have been as likely to have one.

Guess what? Vioxx had the FDA's seal of approval on it.

What about Fen Phen? That had FDA approval also--for almost forty years. It was not until the 90's that the drug began to be used to weight loss. During this time hundreds of women developed heart valve problems as a result of this drug which later led to the drug being removed from the shelves and millions of dollars in lawsuits, all long after it was approved for use by the FDA.

The FDA will not save your life, only YOU can. The FDA serves as a screen to weed out potential problems. The challenge though is, what do they do when they encounter something new that there is no precedent for? More than likely they push it through and you and I end up being the true guinea pig.

This is like the police in a way, they keep us safe most of the time after the fact--that is, after the crime has been committed. It is up to you to defend your own self or home in the meantime so the police (or FDA in this case) does not come knocking on your door trying to solve the mystery of what happened.


By tmouse on 5/14/2010 9:09:41 AM , Rating: 2
The problem I have is the FDA requires test manufactures to show they adhere to standards. We are talking about VERY limited tests, most for small fractions of the disease so passing the test certainly does not mean you will not get the disease nor does failing the test mean you will get it (I consider having an disease associated mutation a bad thing so passing in this case means you do not have the mutation). Without someone explaining this what will someone do if test indicates Hunting's disease, a disease with currently no cure. Some will commit suicide or get themselves sterilized ect. At least with a doctor or genetic consoler you will be better informed. I'm going to assume most of these tests will be PCR based, although they could be high throughput sequence based, but in either case sample handling is crucial. There are a lot of laboratory standards that should be proven to be in place before a company should be allowed to sell a product, else the results are worth nothing. I'm all for less expensive tests, but in these cases given the sheer magnitude of impact on the lives of the individuals a trained person should be available to explain what the results really mean.


By nafhan on 5/13/2010 10:53:34 AM , Rating: 2
It sounds like this may be more like false advertising than "unrestricted genetic tests". They're claiming they will give you advice to plan your future medical decisions, whether or not you should have a baby, etc. Those claims are pretty specific and may be unsubstantiated.
It's possible that if they got rid of some of the specific claims and wording in their marketing and promotional material, they may be able to sell it without a problem. Take a look at some of the herbal remedies out there for example.


FDA stands for what?
By smackababy on 5/13/2010 10:07:32 AM , Rating: 3
The Food and Drug Administration. This test, according to the article, requires only a saliva sample sent back to the parent company. I don't understand how they can try and ban this? It has zero effect effect directly on the consumer's health. Is it the FDA's job to prevent me from making terrible life decisions? I don't think so!




RE: FDA stands for what?
By AntiM on 5/13/2010 10:37:42 AM , Rating: 2
I agree, it's neither a fodd or a drug. Nothing passes into the person's body. I'm glad we have the FDA looking out for us, but I don't think this falls withing their jurisdiction.


RE: FDA stands for what?
By Divide Overflow on 5/13/2010 1:35:36 PM , Rating: 1
I guess you'd want to prevent the Navy, Air Force or Marines from having anything to do with solid ground then too, huh?


RE: FDA stands for what?
By Ristogod on 5/13/2010 10:42:29 AM , Rating: 2
Agreed. What part of any of this has anything to do with Food or Drugs? It's just another example of some unrestricted government program illegally and maliciously attempting to regulate the free market to protect the interests of the government and empower them with more power and control.


RE: FDA stands for what?
By JediJeb on 5/13/2010 10:54:02 AM , Rating: 1
Considering how cheap these test are I imagine they are trying to regulate them because the medical labs would charge 5-10x more for the same test even though this company is easily making a 100% profit on the test at their prices. It now costs between $40k and $90k for the machine to do the test, and the consumables are a few dollars per test, so if you sell 9000 kits at $10 each you have paid for your equipment, a few more to pay for the consumables then the rest is pure profit. You can set up 96 tests at once on the machine so it doesn't take much time for the lab tech to process enough sample to make a nice profit either.


RE: FDA stands for what?
By clovell on 5/13/2010 5:44:32 PM , Rating: 2
They're trying to regulate them because they're unproven.


RE: FDA stands for what?
By Kurz on 5/13/2010 6:29:30 PM , Rating: 2
Are you consuming anything?
NO!

There is no need for the FDA to regulate it then.


RE: FDA stands for what?
By amanojaku on 5/13/2010 10:50:55 AM , Rating: 3
The FDA has the right to oversee this product because it's considered a medical device, and part of a larger overall medical practice. The Center for Devices and Radiological Health is an FDA branch that is responsible for premarket approval of medical devices, from the simple class 1 toothbrush to the complex class 3 pacemaker.

http://www.fda.gov/MedicalDevices/DeviceRegulation...

According to the source article:
quote:
The FDA has never exercised its authority to approve genetic test kits because the kits have historically been used by doctors and other health-care professionals, and such tests conducted solely within labs are certified by the Centers for Medicare and Medicaid Services.

Riley said Pathway Genomics overstepped its bounds when it announced its plans to market the tests directly to the consumer at 6,000 of Walgreen’s 7,500 stores, and allow consumers to take their own saliva samples to return to the lab. Pathway also is promoting the tests’ role in helping people decide drug dosing and other treatments, Riley said. http://www.pathway.com/more_info

The FDA wants Pathway Genomics to submit data showing that its tests give accurate results, Riley said.

“The claims have limitations based on existing science, and consumers should not be making important medical and lifestyle decisions based on these tests without first consulting a health-care professional,” Riley said.
This product is clearly intended to be used for medical purposes, as stated by the manufacturer. It's up to you to trust the results, but if you do, and they're incorrect, you could be in serious medical trouble. Which means you'll sue Walgreens for selling it, Pathway for making it, and the government for not regulating it. The FDA is just trying to cover its ass, and yours.


RE: FDA stands for what?
By porkpie on 5/13/10, Rating: -1
RE: FDA stands for what?
By DanNeely on 5/13/2010 11:52:28 AM , Rating: 3
The test *claims* it will tell you if you have gene X. What the FDA is asking for is proof that its results are accurate.


RE: FDA stands for what?
By clovell on 5/13/2010 5:37:48 PM , Rating: 2
If you're of the mindset that we don't need independent experts to oversee the specificity, accuracy, false-neg/pos rates, manufacture, and recommended clinical use of diagnostic devices, I don't think you're going to see reason here, either.

So, to try a different tact - You realize your toothbrush was made in China, right? Do you really want the FDA to stop checking up the toothbrushes they're selling you?


RE: FDA stands for what?
By FaaR on 5/13/2010 11:38:08 AM , Rating: 1
Your post read as: "How dare the government try to make sure a test does as advertised?! We DEMAND snake-oil!"

But whatever. You people should get whatever's coming to you, wether that's non-working DNA tests, or dietary supplements containing mercury or whatever.

Stupididty may not be contagious per se, but there's sure a cure for it and I'm sure some enterprising free marketeer is willing to sell it to you for a price, just as soon as the FDA steps out of the way.


RE: FDA stands for what?
By Earthmonger on 5/13/2010 1:45:51 PM , Rating: 2
Placing your trust blindly in the FDA is the scary thing. At some point in this litany of responses, I do believe it was forgotten that this is the "American Medicine" industry being discussed. The dollar goes a long way towards securing FDA approval. So, these "snakeoil peddlers" are apparently not paying their dues, and that's ruffling some feathers is it?


RE: FDA stands for what?
By Earthmonger on 5/13/2010 2:09:00 PM , Rating: 2
A couple of links for you all:
FDA's Biggest Blunders
http://health.msn.com/health-topics/articlepage.as...
Fixing A Failing FDA:
http://health.msn.com/health-topics/articlepage.as...

Hell, just Google the FDA. There are literally thousands of articles criticizing them. That the drug companies actually pay the FDA is not helping their case.


RE: FDA stands for what?
By clovell on 5/13/2010 6:07:51 PM , Rating: 2
Regulatory agencies, including the FDA have learned from a lot of these. The application fees that drug companies pay is weird, but from a financial standpoint, the agency doesn't have the resources to review the applications otherwise. It's a long way from perfect, but I wouldn't give them hell over this.


RE: FDA stands for what?
By smackababy on 5/13/2010 2:09:32 PM , Rating: 2
I don't demand snake-oil, I demand to be able to sell products not relating to foods or drugs to consumers. If the product I am selling is complete crap, it will be called as such and not sell. I don't need big brother looking in (not "out for me") on how I spend my money.


RE: FDA stands for what?
By Reclaimer77 on 5/13/2010 4:22:51 PM , Rating: 3
The FDA is just another part of government control. There is a zero, REPEAT ZERO, percent chance that a consumer can be harmed by this product.

All other arguments are moot. The FDA supposedly exists to "protect" the Consumer. Well in this case the consumer needs no protection.


RE: FDA stands for what?
By clovell on 5/13/2010 5:41:32 PM , Rating: 1
Right, and maybe I should be allowed to tell people their LDL levels by tasting a couple drops of their blood.

The product has not undergone the necessary testing to ensure it's effective and now all of a sudden the FDA is the bad guy?


RE: FDA stands for what?
By Kurz on 5/13/2010 6:36:55 PM , Rating: 2
The product itself doesn't do the testing...
The person who purchases the Kit sends it off to a lab.

Just like a engine Oil Test... Oil test isn't the end all be all of Engine Health. It just shows the potential of problems.

The FDA's been the bad guy for YEARS!
They hold off Life saving drugs for a decade people die in the mean time. Then they boldly state we now saving X amount a year. When that X amount times 10 already died from them staling the process.


RE: FDA stands for what?
By JediJeb on 5/13/2010 7:01:49 PM , Rating: 2
If I wanted and accurate measurement of my LDL I would go to a doctor and have him check it. If I just wanted something to run at home to screen it for the heck of it then I wouldn't care if it was 100% accurate.

Yes the FDA regulates medical devices even down to home use thermometers. I haven't seen exactly what the procedure is, but it sounds like a regular PCR screen looking for markers for certain genes. Instruments to run these can be purchased by anyone if they want to invest the money. They are used in food labs now to test for bacterial contamination by DNA identification. For the food tests the process is already approved by the FDA and if I wish to start a lab and run that test I have to get FDA approval of my quality control but not reapproval of that testing method because it has already been approved by the FDA. If I want to run that test for Waste Water to look for bacterial contamination I need no approval in most states since the test is approved and I just have to list the test method I am using. If I am running the test for a non-compliance sample I need no approval of any kind because that number isn't reported to anyone in any authority.

The problem becomes if the use of this test will be used for anything more than curiosity. If it has the same disclaimer as nutraceuticals and suppliments "this product is not for the diagnosis, treatment, or prevention of any medical condition" then really the FDA can't regulate it. But as a client of our has found out, if you make any medical claim at all, you must get FDA approval. If you sell ground up carrots and claim they improve your vision you fall under FDA regulation, if you sell ground up carrots and call them Orange Stuff and make no claim, but list all ingredients as carrots, that falls under a natural product and is not regulated(though the laws are changing soon to make them regulated). I think this is what this company is shooting for, just disclaimer it with something about "this is only for informative purposes, you must discuss any results with your physician before making determinations about your health" they will be covered.

As for the FDA wanting to approve the kits, the kits are only a mouth swab, which is probably already approved. If the process is already something that has been approved and they are just calling it by another name same thing applies. Depending on what this actually is, it would be a waste of efforts to have the FDA reapprove something already proven to work, on the other hand if it is something totally new, it would be good to have the FDA look into it. It's bad to argue strongly for either side until all is known about the products.


Think of the children!
By sintaxera on 5/13/2010 10:10:22 AM , Rating: 2
My wife and I are expecting our first child in November. I would love to have this test available in order to see what potential problems our child might develop in the future. My wife went years with undiagnosed hypothyroidism as a child, and it stunted her growth. A test like this could help point to potential problems before they happen, making future diagnosis easier.




RE: Think of the children!
By tmouse on 5/14/2010 9:23:40 AM , Rating: 4
I would really suggest you go to a genetic screening center if you have concerns. These tests are only really effective in rare circumstances for many of the conditions this company tests for and at present we do not know what controls they have in place to prevent cross contamination, mixing up results or even detecting false positives/negatives. without some form of adherence to ISO standards the results are worth nothing. I find it hard to believe a real company with the expertise to do these types of tests would be ignorant of the requirements for FDA approval. It shows sloppiness and a motive for profit over safety in my opinion. Some of these tests could lead you to believe you may have an incurable disease and even if you go to a doctor and find they were wrong was it really worth the suffering you will got through before you get the results? Keep in mind for almost all of the tests, not having the mutation certainly does not mean you will not get the disease, and in many having the mutation just means you have a greater probability of getting it NOT a certainty. While $20 is cheap if there is not some form of certification by an independent 3rd party that the company is doing things responsively you might as well donate the $20 towards research or a something that make you happy.


Gattaca!
By maevinj on 5/13/2010 10:28:40 AM , Rating: 2
I guess now we can get samples of other people and send them in to see if they're what we are looking for!




RE: Gattaca!
By PAPutzback on 5/13/2010 10:34:24 AM , Rating: 2
Good idea. I wonder if you could send a piece of gum through in the sample container.


RE: Gattaca!
By tmouse on 5/14/2010 9:29:12 AM , Rating: 2
You chuckle but the potential for invasion of privacy in not insignificant here. Some one could get saliva to get information if that is what they are using. Also you had better hope they will not sell the results or at least have safeguards to prevent the data from getting in the wild. They are already showing a willingness to bypass well known requirements to be first to market who knows what else they are willing to cut corners on.


By imaheadcase on 5/13/2010 10:43:09 AM , Rating: 2
How about removing the "homeopathy medicine" on store shelves currently? Thats right, they sell that BS scam stuff at wal-mart. Yet its not pulled by the FDA.

Stuff people have died from because they think it actually works as a replacement for actual medicine.




By perspicacity on 5/13/2010 11:06:33 AM , Rating: 2
I agree... I don't know why the FDA doesn't include that and "herbal supplements" with their reviews. That's been a loophole for a long time.


By BansheeX on 5/13/2010 10:23:43 PM , Rating: 2
Indeed, homeopathy (not to be confused with holistic medicine) is a total scam. It's basically just water. James Randi gives a good speech on it, but no one seems to be listening.

http://www.youtube.com/watch?v=BWE1tH93G9U


What if...
By Johnny12 on 5/13/2010 1:26:41 PM , Rating: 3
What's going to be real funny is when some shady employee starts selling your genetic info to insurance companies. I can see it now, "Sorry Mr. Smith, your cancer is a pre-existing condition, you took a genetic test 15 years ago that proves it..."

Hopefully that couldn't/wouldn't happen, but I wouldn't put it above some companies to try.




RE: What if...
By Divide Overflow on 5/13/2010 1:34:10 PM , Rating: 2
Except that the Genetic Information Nondiscrimination Act was passed a few years ago to prevent this from happening.


its WALGREENS you idiot
By kattanna on 5/13/2010 10:28:25 AM , Rating: 3
jesus.. cant you even read your own linked press release

its not walmart its walgreens




let me get this straight
By mattclary on 5/13/2010 2:17:00 PM , Rating: 3
You can market snake oil as long as you call it a supplement, but I can't spit on a stick without approval?




Often confused...
By chagrinnin on 5/13/2010 12:11:46 PM , Rating: 2
...with the not-so-popular Garden Gnome Test.




By frozentundra123456 on 5/13/2010 5:51:58 PM , Rating: 2
I work in medical research, and we use extensive measures to ensure data privacy. In fact, we have a whole department dedicated to human studies and how to correctly collect, secure, de-identify and process clinical data. Now you can go down to a local store and find your genotype???

I have several problems with this.

The first is that it must be proven to work accurately to tell what genotype you have. Someone has to oversee this, whether it is the FDA or some other agency. Do you want someone to tell you that you have a genetic weakness to alzheimer's disease and not be sure the typing is correct??

The second thing is that the effect of ones genetic makeup is only one part of getting a disease. Genetic testing should be done with the consultation of a physician who can tell you what the test really means and to help you deal with the results if there is a problem.

Finally, I could see legal ramifications for this in regards to employment and obtaining health and life insurance. Can an employer or insurance company force you to disclose if you have taken any of these tests, and if you have a genetic suceptibility to some disease can they deny employment or insurance coverage or increase your rates? There is a confidentiality for medical data between a doctor and a patient, but if someone tests himself, can he be forced to disclose the information?? Also, what safegards are in place to ensure that the company or a disgruntled employee does not give out the data, is it coded somehow?(de-identified).




Um,
By xler8r on 5/13/2010 9:57:17 AM , Rating: 1
Did you people forget? The V's are here and their stuff is much better....
Silly drug company :p




Idiot.
By icanhascpu on 5/13/2010 12:41:40 PM , Rating: 1
http://www.suntimes.com/business/2261090,WALGREENS...

Your inability to even read your own links tells us more than we need to know.




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