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New Drugs Trail Many Old Ones In Effectiveness Against Disease
Lasrick tips this report from Reuters:
"Despite the more than $50 billion that U.S. pharmaceutical companies have spent every year since the mid-2000s to discover new medications, drugmakers have barely improved on old standbys developed decades ago. Research published on Monday showed that the effectiveness of new drugs, as measured by comparing the response of patients on those treatments to those taking a placebo, has plummeted since the 1970s. 'While experts agree that tougher trials and similar factors explain some of the decline in drugs' reported effectiveness, something real is going on here,' said Olfson. 'Physicians keep saying that many of the new things just aren't working as well,' and therefore prescribe antidepressant drugs called tricyclics (developed in the 1950s) instead of SSRIs (from the 1980s), or diuretics (invented in the 1920s) for high blood pressure instead of newer anti-hypertensives.'"
... it looks funny,
In a rich man world.
I am not surprised of this not-so-new news. The same is happening with advertisement where the mantra is "shout shout 100 times to get that one single client to spend the money".
We have a saying that basically goes: Do not shout "The Wolf" when there is no wolf. When the wolf comes for real, noone will belive you.
I see you've been trialing your high school peers in English recently. :-)
Ezekiel 23:20
It's a verb. It means they're behind them. Trial wouldn't even make sense at that place in the sentence.
Big Pharma Big Bucks is a decent documentary covering this: http://www.youtube.com/watch?v=zqCdZ19y39s
Additional Reading: Ben Goldacre's Bad Pharma, Jacky Law's Big Pharma, Marcia Angell's The Truth About the Drug Companies and Irving Kirsch's The Emperor's New Drugs Exposed.
Companies are out for profit. That in itself isn't bad, but due to stockmarket pressure that becomes all they care about and start chasing the easy money spinners. The easiest money is repackaging old drugs. New drugs are too risky.
BTW The Chaser's Checkout did a hilarious piece on Complementary Medicine: http://www.youtube.com/watch?v=QMYXKSy2fb8
1. Can't make any money unless you hold patents (monopoly) and can charge any price you want even [especially] at the expense of loss of life for those who cannot afford it. (They are just dying to get a new drug!)
2. People won't buy your crap unless it has the word "new" on the label. (Microsoft has driven that notion out of us over the past few years though)
Real breakthroughs and discoveries are rare. It seems a month doesn't go by without my hearing some new kind of benefit of using aspirin or acetaminophen.
What really needs to happen:
1. People need to be more careful about their use of drugs -- a body less accustomed to drugs in it shows a better response to drugs when they are needed.
2. People need to be more careful about how they live their lives and to take responsibility for their bodies. I could go on forever about that.
3. More work needs to be done to discover the causes of the maladies plaguing our modern world. We already understand that lots of the cause IS our modern world, but no one wants to talk about it because we might have to give something up.
There's less or no money in any of these ideas. Consequently, it won't happen.
If the doctors are still prescribing old effective medicines instead of the New! Improved! Profitable! ones, the medical industry has clearly failed to inform the doctors properly. More money must be channeled into marketing, instead of this research stuff, which is way too expensive anyway.
If patents did what they were supposed to do (like they did years ago) this probably wouldn't be such a big problem now ......Instead of promoting inovation...now they just stifel it...greater cooperation between companies( and scientists) would probably make a bigger difference...
Until you look at how much goes into regulatory compliance. Not to say the regulations are necessarily bad, but they are expensive and they are influencing drug companies to be highly risk averse. Instead of exploring big changes, they go after incremental improvements.
Law of http://en.wikipedia.org/wiki/Diminishing_returns , low-hanging-fruit etc.
This doesn't really address the whole issue, but remember that the war on drugs has stopped scientists from being able to conduct research for decades. LSD and Ecstasy both had incredibly promising properties in treating some illnesses, especially in the area of mental health. This was until research was banned by governments around the world. I wonder what sort of illnesses, diseases and conditions we'd have cured today if they hadn't banned it.
It pays to remember that through drug prohibition governments are not just waging a war against the individual's rights, but waging a war against scientific research.
Perhaps the older drugs were manufactured for maximum effectiveness and the newer ones for maximum profit.
Beta sux! Join the Slashcott! http://hardware.slashdot.org/comments.pl?sid=4760465&cid=46173047
So what?
Sure the old drugs are great, but there's plenty of new ones that are great too.
Take statins for example - relatively new class of medication that have dramatically changed the treatment of high cholesterol - which leads to the number one killer of heart disease. Another example - artemisinin - great treatment for malaria, relatively recent invention.
Not to mention the survivorship bias http://youarenotsosmart.com/2013/05/23/survivorship-bias/ - there's heaps of old drugs that just aren't used anymore because frankly they were no good and had a ton of side effects. You don't hear about those ones much simply because they aren't used. This gives the perception that 'the old drugs are better' when in truth they were just as bad or worse, and only the good ones have stood the test of time.
But even if it were true - should we then give up drug discovery? Give up the chance to find the next great drug just because the low hanging fruit are already taken? What exactly is the solution to this?
One of my meds (not to mention millions of other people's) was discontinued without notification, because the patent expired. They replaced it with a new one that was chemically the same but in capsule form. Even the marketing for the new drug says it is exactly the same. Nobody has it in stock though. Don't tell me they are "recovering R&D costs" because that ship has sailed. The drug is over $400 a bottle, does nothing new, it doesn't work better, and the active chemical has been around for a long time now.
I am an epileptologist, and I would certainly love to see more effective anti-seizure drugs on the market. But although the newer anticonvulsants aren't necessarily better at stopping seizures than older ones (like the classic four: phenytoin, carbamazepine, phenobarbital, and valproic acid), they are better tolerated, have fewer severe adverse effects, have much more predictable serum concentrations, fewer drug-drug interactions, and require little to no routine bloodwork monitoring. For the 1% of the population suffering from epilepsy who have to take these drugs on a regular basis, this has been a significant change.
Tenemus pyrobolos atqui jacimus cognitiones.
I once talked to someone who had intimate knowledge of how pharmaceuticals worked and he told me that pharmaceutical companies basically didn't do any research any more because any investment in research was a long term risk and therefore looked bad on short term quarterly report.
After all, any research item can very well turn out to be a dead end, and if the research (eventually) turns out to be promising then it'll still be a long time before you'll see it turn a profit ... and as a CEO you might not even work there anymore by that time, so why bother.
Apparently it's expensive mostly because the moment you discover a new compound you need to patent it ASAP before you actually figure out if it's useful or not, otherwise a competitor might patent it first, and applying for international patents is expensive, and *a lot* of patents need to be applied for.
He also told me that about 90% of all the new drugs actually come from research out of universities, not the pharmaceuticals themselves, and that the vast majority of the money they spend is spend on PR, commercials etc. instead of anything actually useful to society.
They're just trying to keep one step ahead of the generics.
Dude, do you even grammar?
Many drugs are looking worse because of publication bias - like the new anti-depressants.
Then as far as say antibiotics, we are seeing resistant strains of bacteria coming into being - partly because of the abuse of antibiotics.
And yes, I'm sure there's a bit of manipulation of drug trials and number massaging.
And then there is a combination of the above.
How does that make sense?
Several reasons for this:
1. Patent Law - Because all most all of the simple compounds have been patented, with the patent already expired, New drugs have to get more and more complicated in order to guarantee gaining a patent. More complicated means more expensive, but not necessarily more effective.
2. Increased safety - The requirements to get a drug on the market keep getting tougher and tougher. Almost everyone in the industry agrees that if aspirin was developed today, it would be a coin flip as to whether it would gain approval. (And certainly wouldn't be available OTC.)
3. Laziness - Many new drugs are just minor modifications of existing drugs made to get around patents. This is unlikely to provide any benefit to patients other than breaking the other company's monopoly. See Viagra vs Levitra: they are effectively identical.
4. Increased difficulty in animal testing - Years ago you could do anything to mice/rats, and the ethics committees only cared about larger animals. Now you have to argue in front of a panel that there is no way an animal could suffer as a result of your testing. I am talking about mice that are going to be killed at the end of the month anyway. And don't even think about using the word LD50: you will be looking for a new facility to do testing for you. This forces more testing back into the test tube, and in vitro environments are different enough from a real body that it is common to see something that works in a test tube to not work in a mouse, and vice versa.
5. Current failure of computer modeling: A lot of research money has moved from trial/error research by chemists to using software to model binding sites of proteins and trying to compute structures that may fit. While this may one day work, I know of no drug on the market or in clinical trails that was developed using computational chemistry as a primary tool. Note: Computational chemistry has brought some good things with it - see Lipinski's Rule of 5, but that was the result of a statistical analysis rather than modeling.
Yes, I am a medicinal chemist.
Patents kill the flexibility enabling companies to create new drugs without spending inate amount of money in order to avoid the pitholes left by the competition. And Marketing works better on "illnesses" bought be people in good health and with enough money, so Attention disorder medication (paid by young parents) E.. disorder payd by the midlife crisis, etc... it also works better on variations of existing medications that are going out of patent protection... Assume Pharma X makes 50% of it's income with Y it will get the most "powerful" manager to handle this business line, so even if Z is mutch more interesting, has future potential, the "Power Manager" will do everything he or she can to make sure the Z stays "small" and Y wich is their fiefdoom stays "big". Additionally once you cure a couple of illnesses you have to way for the germs to mutate away and then they typically become harder to manage, or you do not really need a new medication, and what is left is "harder"... So although the main reasons are "evil", part of it is just nature.... -
My doctor won't even offer me new drugs, he will fall back to the tried and true warriors that have been known to work over the last 30 years. He knows for the most part the kind of side effects they give off and how they will work with my body. The new stuff is to unpredictable, and well I know that new medication gets tested ( be it poorly ), they just can't plan for the side effects, as I've developed side effects off new medication that weren't even known.
I am led to believe by the smart medical people I work with that the newer anticoagulants are a lot better than warfarin, in particular warfarin's side effects and long list of interactions.
While the new drugs are often less effective when compared to themselves, they are usually similarly or more effective when on top of the standard of care. For example, what tends to happen is that in the old studies with diuretics people had a systolic blood pressure going in of 200 mm Hg. Now, people are already on those diuretics and have a systolic blood pressure going in of 150 mm Hg. Given the same drug as a comparison, you often see that either the new drug is better in efficacy or similar in efficacy and better in safety.
That's all that has to be demonstrated for a new drug, at least in the US. Not that it is more effective than a previous drug, only that it is safe and more effective than a placebo. So a new version of an old drug might replace a phosphate group with a sulfate group, and it does not matter if the new drug is less effective than the old one, it can be patented and handed over to the marketing department for another 15 years of cash flow. There are a million variations possible, rinse and repeat as needed to maintain the monopoly and high price.
The old drugs are 'protected' by patents that have expired. There are generic versions available. The 'cost of the research and development' has been paid out, and the older drugs are now actually affordable.
It's no surprise that the drug companies want people to use the 'New! Shiny!' drugs and discard the old ones. They make a lot more money. Whether the drugs work or not, they want people OFF those nasty old drugs they don't make much money producing.
It's all about making money.
Ed Vogler is a brilliant businessman, a brilliant judge of people, and a man who has never lost a fight. You know how I know that the new ACE inhibitor is good? Because the old one was good. The new one is really the same, it's just more expensive. A lot more expensive. See, that's another example of Ed's brilliance. Whenever one of his drugs is about to lose its patent he has his boys and girls alter it just a tiny bit and patent it all over again. Making not just a pointless new pill, but millions and millions of dollars. Which is good for everybody, right? Except for the patients. Psht. Who cares? They're just so damn sick. God obviously never liked them anyway.
This sort of thing is to be expected in a for-profit system of health care products: If the primary reason for doing something is profits rather than results, you get perverse incentives. For example, it's far more profitable to create an ongoing treatment to a disease than it is to create a cure for that same disease, because a cure is a one-time purchase but an ongoing treatment can require payments for 40 or 50 years.
I am officially gone from
It's expensive to make drugs. Most of the basic research is done by the government, and then the drug companies swooped in, ran a few study groups and patent the thing. We've been in 'Austerity' mode for about 10 years now. Slashing gov't left and right so we could slash taxes. Didn't anyone realize there would be consequences?
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... the patient, or patient's caregiver's.
I can say this from experience, growing up with parents that thought there was a magic pill for everything. I suppose them not having any religion, could have contributed to this, *just* as much as money.
I say this because, again, people want a magic pill. Doctor says "Oh there this new thing we'll put you on." Patient takes it and is unable to google anything, or pre-google, just took it with absolutely no knowledge of what negative side effects it could have. I was personally put on every anti-depressant of the early 90's, and they did a number on me. I guess being diagnosed by a shrink at the age of 12 (this was around 1989) with ADD simply by me looking up when the madman snapped his fingers after giving me a puzzle to complete. I'd look up and say "what?" He would say nothing, then repeat that process. Looking back, I should probably sue the guy as i'm sure the transition of that to methamphetamine later (Rx again) could have only harmed me in my pre-pube days.
Perhaps the new drugs sit in judgement of the old ones?
It's not enough that drug companies are putting out inferior, less-effective drugs to replace better ones, but they're putting all their marketing billions into making sure that the doctors prescribe the less-effective drugs instead of the better ones.
Note to corporate heads: when the mobs come to disembowel you and hang your corpses in the town square, don't say you were never warned.
You are welcome on my lawn.
Ah, yes, the results, for the patient, might not be any better but the profits on new patents is far higher.
Seriously, you can't spell Trial right in a drugs research article?
You look a little silly today.
"What the American public doesn't know is what makes them the American public." -Ray Zalinsky (Tommy Boy)
They are about exclusivity. The patent holder only needs to convince doctors to prescribe the medication to have guaranteed profitability. I suspect more is spent on marketing to said physicians than is spent on clinical trials, by a pretty wide margin.
Why bring religion into it?
I would guess those who already believe in magic are more likely to to believe in a magic pill than those who don't believe in any magic.
I guess being diagnosed by a shrink at the age of 12 (this was around 1989) with ADD simply by me looking up when the madman snapped his fingers after giving me a puzzle to complete.
He'd already decided to diagnose you. If you hadn't looked up, he would have called it an example of hyperfocusing, the other half of ADD. Sounds like a charlatan's trick.
Are the pills less effective or our problems are getting worse?
I know, right? I'm just glad I remembered to tick the 'Post Anonymously' box.
Crap.
"If you have nothing to hide, you have nothing to fear." - Every fascist, ever
Maybe the placebos are getting more effective!
Warfarin, originally used as rat poison, is still the number one anti-coagulant. However it requires regular monitoring (blood tests) to ensure therapeutic levels are being taken or there is a risk of embolism or internal bleeding.
When Plavix came out ten or so years ago the major draw for a lot of patients was that it required no regular monitoring which is a pain in the ass for users of warfain. Unfortunately because Plavix works by a completely different method of action it can't be used as a universal anticoagulant like Warfarin (the method of action for Warfin has been well understood for a long time now.)
Conditions like Factor V Leiden mutation are still being treated with Warfarin with very low or no side effects where as with Plavix you run the risk of Severe Neutropenia and unlike Warfarin, who's effects can begin to be negated with a vitamin K injection, there is no antidote for Plavix.
It makes me wonder how much of an improvement in treatment was really made. Maybe it was worth it to some people to not have to get blood drawn every month. But for all that research to be done and have it not work for all conditions and have many more unpredictable side effects (even if they may be in low occurrence) tons of people have switched from paying $3 a month for warfarin to $60 for plavix, which, if you don't have health insurance, is about the same price if not more expensive than getting a simple blood test.
Geeze the more I talk about it the more I imagine a hamster running around in a wheel.
Even chemotherapy treatments these days haven't changed too much. Methotrexate and Vincristine are still among the number one chemo drugs used in leukemia and lymphoma treatment regimens after almost sixty years.
The difference these days is that we know what doses are better for treatment and we know what drugs to use in combination with them to ensure a better prognosis
The Blade Itself
Comments on efficiency of use of funds by corporate overlords aside, is anyone really surprised that R&D in general (not just pharma) is showing diminishing returns? All the low-hanging fruit in science and technology has already been picked. Given that what is knowable and doable has limits, R&D eventually will become asymptotic to those limits. Investment will have to keep increasing to reap ever smaller gains. Disruptive discoveries/inventions and paradigm shifts make the progression not a smooth curve, but as the frequency and magnitude of such events is decreasing, on a large time-scale the overall progress is bound to still be asymptotic.
"Politicians and diapers must be changed often, and for the same reason."
They just lost a case in India a month or so ago, where the Indian court decided that there was so little difference in outcomes and side effects that they refused to allow a patent on a new drug that was to replace one whose patent was expiring.
And the ones in the last couple years pulled off the market in the US as having more side effects, and not especially better than the old ones in danger of being sold as a generic (the list is left as an excercise for the reader)?
mark
But more to the point, (in terms of the FA), money is what drives new drug research, and not as much money can be made off of drugs whose patent has run out. That revenue can only be replaced by coming up with a new patented drug for the same profitable ailment.
-- sudon't
Air-ride Equipped
I am pretty sure OP means "mid-00s".
The "mid-2000s" won't happen for about 500 years.
Its kind of makes sense, given that more effective drugs would make their effects more obvious, now we are looking into more obscure drugs.
Tricyclics were nasty; back in the 1980s I had a friend who was bipolar but didn't respond well to lithium (which is also nasty), and they tried her on a bunch of different things, most of which also had nasty side-effects. But they're mostly norephinephrine-serotonin reuptake inhibitors, not MAO inhibitors (which are also nasty and come with warnings about "potentially fatal hypertensive crisis" if you eat the wrong foods with them.) BTW, ayahuasca's main components are an MAO inhibitor and DMT, with the MAOI having some psychoactive effects but primarily making the DMT orally active and keeping it from breaking down for much longer than normal, as well as often causing vomiting.
As far as high-blood-pressure drugs go, my doctor tells me there are about 4 main mechanisms that affect blood pressure, and different drugs work differently. For instance, diuretics generally have more effect on systolic pressure but less on diastolic than ACE inhibitors; depending on the cause of your high blood pressure, you may use one or both of them. And the ACE inhibitors have fewer side effects than some of the other old anti-hypertensives.
Bill Stewart
New Fast-Compression-only CPR http://preview.tinyurl.com/dy575ks
A perfect example of this is when Colcrys was approved. It was a "tweaked" version of the drug Colchicine which was grandfathered (i.e. no patent).
They patented Colcrys and killed Colchicine. The new drug was "purer" than Colchicine but it didn't work for many people. And the price went from $0.09 to $4.85 per tablet. The old drug was also used for treating joint issues (but the new version didn't work).
http://en.wikipedia.org/wiki/Colchicine
UPS Sucks
... many times, that the pharmaceutical companies are fraudsters, that HIV is not the cause of 'AIDS' (and that 99.9% of Slashdotters don't even know what 'AIDS' is), and that vivisection is medical fraud, because an astonishing 92% of drugs which pass animal experiments (though WHICH animal species they pass in, is always different) yet FAIL human experiments, AKA 'clinical trials'...
But you wouldn't listen.
http://www.safermedicines.org/index.php
And yet MORE fraud, this time involving almost ALL cancer 'research' - all of it being a total waste of time:
http://www.bmj.com/content/344/bmj.e2555
It sounds like placebos have just become far more effective in recent years...
Fran
:):):)
1st 1st Poster of the new Millennium!
Some people give up one god only to worship another.
Big spending in big market sections: Diabetes is a huge market and there are tons of research thrown at drugs for it. Even relatively crappy drugs, if they have any vague advantage over current therapy are easy to spin to docs, and general marketing is easy to consumers. Ex: Byetta, Does is do a good job of lowiering A1c (marker for average blood sugar level) no. Is it convenient? No you have to inject yourself. But it usually causes some weight loss unlike most all other diabetes drugs! Sign me up!
Epilepsy is a rarer condition and often has multiple causes and sub-varieties. If you look at FDA indications for newer anti-epileptics they are very seizure type specific and often don't treat difficult types. Part of that is how few people you can get to study because it is relatively rare compared to diabetes, and its such a variable disease it's hard to have large well designed trials that make any drug look especially good.
Second place: "Me Too" drugs. Many pharmacists can spot these a mile away. They are a modification of a competing drug that the original maker forgot to patent that particular variation of structure. Even marginal advantages are enough to market a drug. For instance, pitavastatin is weak sauce compared to older statin drugs, but it doesn't have the drug interactions of the older drugs, which give it a marketable angle. There are plenty of drugs where we got it right early on and everyone tried to make it better. A big one is the beta blocker category. There are TONS out there that tried and failed to match up to metoprolol and carvedilol with a clear advantage.
Form and function: A manufacturer has the original patent rights to a drug and can be the only one to introduce a new dosage form. We make pill A that you take twice a day, its generic is coming out tomorrow but CHECK OUT pill B of the same drug you only take ONCE a day! It's some of the low hanging drug development fruit for the most part.
I have read that there is no high-risk research funded nowadays from big pharmas, because (as any business) they don't like risk. They see the research as an investment. So please, if anyone is involved in this business/science please answer me: how many scientists today are researching a possible method/drug for the complete CURE (not improvement of life expectancy etc) for any cancer ?
the old drugs. We dont give a damn about effectiveness we give a damn only about ass raping you for money. No matter what bull shit about research they shove down you throat, just think in terms of cigarette companies lies. And that is the fact jack. For not calling bull shit when you see it you get to fucking die.
Ah, a news bulletin from the land of "Where the Hell have you been for the last 30 years, asleep?"
I'm not a fan of big Pharma, but this is horseshit.
Tricyclics are substantially more dangerous than the newer generation of medications, sure you can OD on any of the psych medications, but the newer medications tend to be more narrowly focused than the old ones. Have you ever looked at the listing of things to avoid when it comes to MAO inhibitors?
A lot of the problem with the newer medications is that since they target smaller parts of the brain, it's less likely that any one medication will work properly, but it also means that it's less likely that it will interact with some other medication. For instance you can't take Prozac or Paxil if you're taking stimulant medication for ADHD because they use the same channels in the liver, IIRC.
Ultimately, this is not likely to be a problem in the near future as brain imaging scans to see what exactly is going on in the brain become more prevalent and there's more formal testing of what the medicine is actually doing. At present there's very little attention paid to how much of the medication actually gets to the site where it's needed. Something as simple as an undiagnosed food allergy can result in little or none of the medication making it to the brain. Which also effects how much seratonin, dopamine and the rest are there for the medications to work with.
TCAs are indeed substantially more dangerous in overdose but they are globally more effective as well. More importantly, most people on TCAs won't overdose on them. MAOIs are entering an era where we have both EMSAM (a patch that avoids the tyramine toxicity issue) and more selective, reversible MAOA inhibitors that have comparable efficacy to MAOIs but much better safety and tolerability. The problem with newer drugs is not a "targeting of smaller parts of the brain". Many newer agents are more selective with regards to receptor and channel targets (pharmacodynamics). It's the primary reason some newer medications have fewer side effects. Unfortunately, many new drugs don't actually have fewer side effects. Instead they have different ones. As for the example you use, there is no blanket contraindication for fluoxetine (Prozac) or paroxetine (Paxil) combined with methylphenidate or amphetamine class stimulants. The primary issue with fluoxetine is it is a potent inhibitor of 2D6 which means other drugs metabolized by that pathway may accumulate to toxic levels when administered with fluoxetine. Paroxetine also has a host of drug-drug interactions but NOT with stimulants. The two antidepressants you cite are selective serotonin reuptake inhibitors they share virtually no pharmacology with stimulants. As for brain imaging people have been sold a bill of goods with regards to utility in neuropsychopharmacology. fMRI, PET, SPECT, etc with a host of pretty false-color images are nice to look at but have provided minimal advancement in diagnostics or therapeutics. The primary exception is structural/flow imaging that reveals a great big tumor or bleed/clot but a decent neurologist could tell you the same thing for a fraction of the cost. We do have better technology but what we actually KNOW about the brain is not progressing by leaps and bounds. We are taking baby steps at best. We dont' KNOW where medicine should be for most neuropsychiatric conditions and even when we do (Parkinson) we are limited in our ability to target specific areas. The problem with Big Pharma is their mission has always been to make money. They aren't evil and they aren't incompetent. The old FDA hoop was to prove a drug wasn't lethal . . . and that didn't happen until the 1930s. It's actually a fairly recent rule that companies had to show effectiveness. The conundrum for Big Pharma is that serendipity has driven a lot of advancements (vaccines, antibiotics, antidepressants, antipsychotics) and we just aren't smart enough to solve problems from scratch. And we are too impatient (myopic) to invest the hundreds of billions of dollars and decades of basic research to learn more about human development, physiology and pathophysiology from head to toe.
We have replaced the Guinea Pigs of old. The Drug Companies run a few preliminary test to make sure you don't just die right away, send them through the FDA and off we go. Watch one of the commercials a really listen to the contradictions
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