posted
Ron, the bar is so low for food additives, which is what homeopathic quackery is considered, as to make it useless. For it Not to be approved someone must PROVE that it does harm. That someone is not the FDA or the manufacturer, but what ever victims and their families survive to make the case.
And even then the company can argue about it.
I do not know the story of Pleconaril. However I usually try to get my information from one source, so until I research it I will have to say the FDA is doing a better job than not having an FDA around.
Drug companies are companies.
Companies are sociopathic. For the most part they do not try to do good, or to do harm. They only try to make money.
Doctors on their own do not have the time, the energy, the resources or the calling to double check every new drug that some advertiser shoves in their face. Right now Billions of dollars, about 10 times the research budget, are being spent to sell doctors on new medicines.
Saying the removing the FDA because they like to make sure the science is good before allowing possible poisons on the market is a going to somehow enable my family doctor to know not only which medicine I should take, but which of the promised miracle cures the rep is paying him to use is the best based solely on the research of the manufacturer is hard to swallow. Sorry for the big sentence.
If I have a million, I can make a drug called Darthia. It costs me $50,000 to manufacture. I spend $50,000 to buy some scientist to tell me it works. I then spend $500,000 on advertising--drug reps to bribe, coerce, sleep with, or convince doctors int he region that Darthia is great for relieving migraine headaches. $400,000 is on retainer to pay for any issues that come up--law suits, etc. At $5 a pill, I get ten thousand people to get 100 pills and I've made $4 Million in profit.
Right now, this same thing is happening, but instead of the $50,000 to buy someone to say your drug is good, you actually have to make a good drug.
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I've found that it's pretty much impossible to interfere with someone's conspiracy theory of the week.
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quote:Originally posted by Ron Lambert: And yes, Rivka, it was truly the cure for the common cold. That is not an overstatement at all.
What? No. It's absolutely an overstatement. It's not a cure; you'll still go through a cold's full stages even if you start taking it at the absolute onset of symptoms.
But, .. you've taken the position that it is, so there's an excruciatingly minimal chance you can be corrected, I guess?
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If anyone would like to see the full background information used by the FDA to decide on that med, it is herePosts: 1261 | Registered: Apr 2004
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I was an investor in Viropharma at the time when Pleconaril was rejected by the FDA, and the stock price tanked, so I am very well acquainted with the situation.
Darth, I do not advocate eliminating the FDA. For the most part, it does a decent job. I am just saying in this one case involving Pleconaril, PC-type thinking denied all of us something that could have been of great benefit to society.
That is a good observation, where you said that most companies are sociopathic.
One of the really good things the FDA did was refuse to allow Thalidomide to be approved for general use in the USA, even though it was commonly being used already in Europe. A few women obtained the drug anyway, and regretted it, when they joined with many European mothers in having seriously deformed babies. I think it was mainly one woman who was responsible for blocking approval of Thalidomide. She said she did it mainly on a hunch, and took a lot of criticism for it at first. In her case, she went against PC thinking, at least in terms of the example set by Europeans.
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quote:I was an investor in Viropharma at the time when Pleconaril was rejected by the FDA, and the stock price tanked, so I am very well acquainted with the situation.
So you probably lost a bit of money, therefore clouding your objectivity on the matter. But let's not discuss that when examining such statements as 'truly a cure for the common cold', oh, heavens no.
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Ron, while you state that you were well acquainted, I wonder if your information came from the company press releases and journalists' enthusiastic but not scientific articles about the topic. If you have read the backgrounder, great. But if not, I suggest you do in order to actually embrace more knowledge than say you're above it.
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Since Pleconaril was the only medicine actually to affect the mechanism by which picornaviruses attach to cells and infect them, it was truly a cure for the common cold. Not a mere treatment for symptoms, not a mere snakeoil homeopathic remedy that does nothing like Zicam, but an actual treatment that worked. In clinical trials it did reduce the average length of colds for everyone, by at least a day, in many cases more. And it stopped an infected person from being contagious almost immediately, since all the virus shed after taking Pleconaril were deactivated. Pleconaril was formulated using various substances already established as being harmless for humans. It passed its first and second clinical trials with flying colors. All the controversy involves the third clinical trial, with humans. There is no question that the drug did what it was claimed to do. The only questions that arose were side effects for some people. The real reason it was rejected was the possibility that it could neutralize some birth control medications. Everything else was just window-dressing added to make it look like the real reason wasn't the real reason.
I followed the stock and the drug through its clinical trials for over two years. When I saw that Viropharma was going to make a presentation about Pleconaril at a large conference of medical professionals, I purchased more of the stock, and made a profit a couple of days later when the stock went up at about 12 percent, due to the reaction of the people at the conference.
I was certainly disappointed by the FDA's final refusal to approve Pleconaril, and did not appreciate losing money. But I was also motivated far more than most people to keep abreast of all the discussions among investors about it, and read through the official reports (including reading between the lines which you have to do with government-speak and business-speak).
At least I can say that I cut my losses by selling my shares immediately. Some people indulged in a bit of denial, and held onto the stock for a few more days, and suffered even worse when the stock price was halved again.
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quote:I was an investor in Viropharma at the time when Pleconaril was rejected by the FDA, and the stock price tanked, so I am very well acquainted with the situation.
So you probably lost a bit of money, therefore clouding your objectivity on the matter. But let's not discuss that when examining such statements as 'truly a cure for the common cold', oh, heavens no.
I like how Ron assumes that his investment in the company adds to his credibility when making claims about how good a product it had. Sometimes he sounds exactly like I imagine Michael Scott might sound.
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quote:Originally posted by dabbler: Ron, while you state that you were well acquainted, I wonder if your information came from the company press releases and journalists' enthusiastic but not scientific articles about the topic.
posted
Well, at least I know why Ron considers the delay of approval of picovir the "worst failure of the FDA in that institution's history" — it has to be, as he personally lost money on it.
There is no possible way that there is emotional and exposure bias at play, of course.
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Well let me tell you samp, I followed the 2008 Presidential elections much more closely than I had ever done before, I read lots about them, did lots of studying, read many analyses and books after the fact, and have been thinking a lot about it, and I can tell you it was the single most important presidential election in our nation's history.
Funny how that works, neh? Ron probably thinks exposure bias means that he is biased because he was exposed to a financial loss.
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Blayne Bradley
unregistered
posted
quote:Originally posted by Ron Lambert: Since Pleconaril was the only medicine actually to affect the mechanism by which picornaviruses attach to cells and infect them, it was truly a cure for the common cold. Not a mere treatment for symptoms, not a mere snakeoil homeopathic remedy that does nothing like Zicam, but an actual treatment that worked. In clinical trials it did reduce the average length of colds for everyone, by at least a day, in many cases more. And it stopped an infected person from being contagious almost immediately, since all the virus shed after taking Pleconaril were deactivated. Pleconaril was formulated using various substances already established as being harmless for humans. It passed its first and second clinical trials with flying colors. All the controversy involves the third clinical trial, with humans. There is no question that the drug did what it was claimed to do. The only questions that arose were side effects for some people. The real reason it was rejected was the possibility that it could neutralize some birth control medications. Everything else was just window-dressing added to make it look like the real reason wasn't the real reason.
I followed the stock and the drug through its clinical trials for over two years. When I saw that Viropharma was going to make a presentation about Pleconaril at a large conference of medical professionals, I purchased more of the stock, and made a profit a couple of days later when the stock went up at about 12 percent, due to the reaction of the people at the conference.
I was certainly disappointed by the FDA's final refusal to approve Pleconaril, and did not appreciate losing money. But I was also motivated far more than most people to keep abreast of all the discussions among investors about it, and read through the official reports (including reading between the lines which you have to do with government-speak and business-speak).
At least I can say that I cut my losses by selling my shares immediately. Some people indulged in a bit of denial, and held onto the stock for a few more days, and suffered even worse when the stock price was halved again.
... So you think Evolution is a myth... But seem to fully support or accept the fact of medicines developed using knowledge derived from evolutionary theory?
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quote:Originally posted by 0Megabyte: Maybe this isn't the time or place for that, Blayne. Dog piling Ron even on unrelated subjects smacks me as just mean-spirited.
Agreed. Let's try to stick to one argument at a time, shall we?
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posted
Ah, a hint of fairness! What a breath of fresh air! Thanks, OMegabyte and rivka. And a Happy New Year to you both. No visit from Santa's Dark Elf for you!
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posted
I've already commented at length, rivka, and I've already answered--directly or implicitly--all the criticisms. At this point I would merely be repeating myself to people who did not read closely or weigh properly what I said already.
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Oh that's good. I like that. If you don't agree with me, it's because you didn't properly appreciate my point of view. And it's your fault.
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quote:Originally posted by Ron Lambert: I've already commented at length, rivka, and I've already answered--directly or implicitly--all the criticisms. At this point I would merely be repeating myself to people who did not read closely or weigh properly what I said already.
Whenever a person reads your position closely and weighs it properly and then disagrees with you anyway, you default to insisting that it is a result of not reading closely or weighing properly.
posted
Sam, it is clear that what is irreducible is disagreement of opinion. As far as I am concerned, you and Blayne and Orincoro and Rakeesh can take your ill-informed arrogance and proclaim yourselves masters of the apes. Who cares?
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quote:Originally posted by Ron Lambert: Sam, it is clear that what is irreducible is disagreement of opinion. As far as I am concerned, you and Blayne and Orincoro and Rakeesh can take your ill-informed arrogance and proclaim yourselves masters of the apes. Who cares?
I actually don't have an opinion on this particular point, I just object to your logic, which is flawed. I also don't like you.
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posted
To bring this back sorta to the issue of healthcare, this was a headliner on reddit:
quote:Congratulations USA! You now have 50,000,000 citizens without health insurance! And 27% of the uninsured used all of their assets and savings to pay medical bills! 1/4 required medical care and didn't get it due to cost!
quote:Sam, it is clear that what is irreducible is disagreement of opinion. As far as I am concerned, you and Blayne and Orincoro and Rakeesh can take your ill-informed arrogance and proclaim yourselves masters of the apes. Who cares?
Well, clearly you do, Ron. Anyway, you're either self-aware to acknowledge that you might have some bias in a case where you lost some money or not.
Really, most folks expecting to be taken seriously would've simply acknowledged the point and taken pains to explain, "No, I thought of this, took it into account, here's why," as one should when there's a glaring reason the listener perhaps ought to disregard their statements. And in your case we had >two, the other being 'truly was a cure for the common cold'.
I don't claim to be well-informed at all about this particular subject, but I'm sufficiently well-informed about people in general to know that when an individual has gotten burned on an investment, it is prudent to take their statements on that investment with a grain of salt-particularly when their politics start getting involved. Especially when they start making grandiose unlikely statements about common colds.
Now, where's some monkeys for me to be master of?
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posted
you could be an authoritarian ape autocrat, ably aggrandizing absolute authority; an able arch-administrator amongst anthropocene ancestors.
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quote:I can point to tens of millions (at least) of lives saved, and hundreds of millions of lives greatly improved by the elimination of the FDA at some point in the past, no problem; it doesn't take many wonder drugs to do that.
Fugu, I keep hearing these kinds of numbers being thrown around but I can't find a credible source for them. Do you have one?
Frankly, tens of millions of lives saved by eliminating the FDA seems highly improbable. At its worst, average time for drug approval by the FDA was around 3 years. Between 1980 and 1999, the average was 2 years.
The major killers in the US over the past 50 years have been cardiovascular disease, cancer and diabetes. Roughly 500,000 Americans die each year from Cancer. The American Cancer Society estimates that between 1990 and 2005, ~ 750,000 cancer deaths were prevented by medical advances (including early diagnosis, drugs, surgery, radiation, etc). I'll be generous and assume that 50% more could have been saved with out the 2 year FDA delay, and extrapolate that backwards for 50 years and we get 1.25 million lives that could have been saved. Which is a lot, but no where near tens of millions and that's using an extremely generous assumption
Around 800,000 people in the US die annually from cardiovascular disease. Between 1990 and 2000, the death rate from Cardiovascular disease declined ~2% per year. If you could push that curve back 2 years by eliminating the FDA, and extrapolate of the last 50 years, you get around 1.5 million deaths prevented. Large, but no where close to the numbers you are claiming.
2.4 million people die annually in the US. Over a 50 year period, that's roughly 120 million deaths. (Death rates have declined substantially but the population has grown so that's probably a fair estimate). For your statistic to be valid, at least 10% of all the deaths in the US in the past half century could have been prevented by a drug that was under review by the FDA. I just don't think that's remotely reasonable.
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I have trouble believing the FDA would not approve a drug because it decreases the efficiency of birth control. As someone on birth control, I have in the past been informed, use backup method while taking this drug. I have a friend who was young and stupid and when the dr said make sure to use protection while on this pill thought that meant to just not forget her pills and 9 months later had a beautiful baby boy. So, if this drug was so great, why would it be refused when lots of other drugs have the same failing and aren't refused?
I actually would like to see three classifications of drugs-safe, effective and safe and effective. I know a doctor who uses herbal methods. Generally by the time people make it to him, they are going to die (severe burn and infections). He says many methods he believes are not very effective, but for that one person who it works for, it is the difference between life and death. I am aware of, but confidential, some other research where there wan great effects for some people that were pretty clearly an effect of treatment but others had no effect at all. To make it worse, the mechanism was uncertain. So, it was absolutely safe, but the efficacy was overall low. For some patients though, it was a lifesaver. For drugs like that, perhaps labeling them as safe, but not proven effective would be of use.
I also am aware of some treatments that may lead to ten years of improved life, but life threatening side effects. I think a patient with debilitating disease should be able to choose if they want a shortened life for a few years of pain free living. So, effective but not safe. Clearly label, require clear consent but let the patient decide.
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I would really like to see the source for the "tens of millions of lives saved". I want to see what methods they used and what assumptions they made. On the face of it, the number is simply ridiculously high.
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My positiion simply stated is that the FDA is worthwhile, and performs a needed service, but sometimes it can err seriously because of the fallible judgment of humans and their pet biases.
I have also heard it said that under modern guidelines, asprin would never receive FDA approval (it is prone to produce or aggravate bleeding ulcers), so it is a good thing it has been "grandfathered in" as a derrivative of the herbal remedy, willow leaves. Maybe we would still be better off using willow leaves. But the 81-grain asprin dosage has been shown to reduce the likelihood of heart attacks or strokes, while not being likely to aggravate anyone's ulcer. Then again, vitamin E and folic acid probably are just as efficacious for those things.
Rabbit, I would remind you again of Thalidomide, which could have produced a large crop of deformed and even stillborn babies, had it been approved in this country like it was in Europe.
Go back over a hundred years or so, and you will find a medical science that routinely prescribed mercury chloride (calumel) for treatment of many illnesses, and that even taught it was a valid principle to use small amounts of known poisons to combat disease. Even after many medical professionals had finally learned better, it took an agency like the FDA to put a stop to the systematic poisoning of patients.
quote:"Mercury became a popular remedy for a variety of physical and mental ailments during the age of 'heroic medicine.' It was used by doctors in America throughout the 18th century, and during the revolution, to make patients regurgitate and release their body from 'impurities'. Benjamin Rush, a famed physician in colonial Philadelphia and signatory to the Declaration of Independence, was one particular well-known advocate of mercury in medicine and famously used calomel to treat sufferers of yellow fever during its outbreak in the city in 1793. Calomel was given to patients as a purgative until they began to salivate. However, it was often administered to patients in such great quantities that their hair and teeth fell out. Shortly after yellow fever struck Philadelphia, the disease broke out in Jamaica. A war of words broke out in the newspapers concerning the best treatment for yellow fever; bleeding or calomel. Anecdotal evidence indicates calomel was more effective than bleeding."
It is also worth noting that medical historians believe that Sir Isaac Newton's five-year-long period of insanity was caused by his imbibing mercury--his lab notes described the taste of mercury in various experiments. The expression "mad as a hatter" came from the fact that hat makers routinely used mercury in the manufacture of felt, and in the persuit of their craft, often inhaled mercury fumes. Many of them went insane, at least for a time.
[ January 01, 2011, 05:07 PM: Message edited by: Ron Lambert ]
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quote:I have also heard it said that under modern guidelines, asprin would never receive FDA approval (it is prone to produce or aggravate bleeding ulcers), so it is a good thing it has been "grandfathered in" as a derrivative of the herbal remedy, willow leaves.
I have heard many things said. I have heard it said that the world is flat and we didn't land on the moon. Where's this inescapable procedure of FDA approval that would invariably prevent approval of aspirin? I don't think it exists.
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quote:Originally posted by Ron Lambert: Prove it doesn't exist.
The FDA approved aspirin for stroke prevention in 2007. So yes the idea the aspirin could not be approved under modern FDA guidelines is a complete myth.
The FDA has approved naproxin and ibuprofen for over the counter use. Both of these medications have similar adverse side effects to aspirin.
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quote:Originally posted by Ron Lambert: Prove it doesn't exist.
Ok here.
quote:
Contained within that quote is all the relevant regulatory guidelines of the FDA which would have part-and parcel disallowed the approval of aspirin without grandfathering.
Notice how the quote is empty.
Ok, that was pretty easy! Let me know if you find anything which can be put into that quote.
quote:Rabbit, I would remind you again of Thalidomide, which could have produced a large crop of deformed and even stillborn babies, had it been approved in this country like it was in Europe.
Why are you reminding me of this, I have never disputed it. I have been asking specifically about Fugu13's claim that tens of millions lives could have been saved by eliminating the FDA. I would still like to see some sources for this number because it seems outrageously high.
[ January 03, 2011, 08:40 AM: Message edited by: The Rabbit ]
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posted
And I have been contending for largely the same thing, Rabbit, that the FDA has done far more good than harm. I would say that tens of millions of lives have been saved that would have been lost without the FDA. I only stipulate that sometimes the FDA can and has made mistakes, because they are all human.
I talked to a person one time who was lamenting about the terrible experience she had on jury duty, even though the evidence (including multiple direct eye-witnesses) was conclusive that the accused followed someone into a fast-food drive-in, brandished a gun and yelled at the driver for some perceived provocation on the road (a road-rage case). One jurer held on for days because the defendent was a medical doctor, and she said she just couldn't believe a doctor would behave that way.
Doctors can behave wrongly, because they are no less human than anyone else. Likewise scientists can behave wrongly. Likewise government officials can behave wrongly.
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posted
Ron, I still have no idea why you chose to address me with the question, implying my arguments indicated I'd forgotten the obvious. Perhaps you were confusing me with someone else?
My question to fugu13 still remains. Can you give me a source for your numbers? I have searched and the highest estimates I've been able to find for lives lost due to FDA delaying miracle drugs are ~100,000, which is a factor of 100 less than the minimum number you cite. I would not expect you to make up that kind of number so I am very curious where it comes from.
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posted
Sorry, I've mostly been avoiding this thread because of the, ah, lowering of quality by certain posters.
The estimates you're seeing are around 100k statistical lives per year. That is, entire average human lifespans made to exist that wouldn't have before, each and every year. By lives saved all I meant was that people who would have otherwise died from something would not die from that thing, or at least not for a very substantial period of time. If the average extension of lifespan is around twenty years, that's already about 500k lives saved in my terminology, easily hitting tens of millions over a few decades. Also, that's a relatively recent estimate; I said " by the elimination of the FDA at some point in the past". The rate of lives saved by new drugs has decreased dramatically from the mid-20th century, roughly when I was imagining the elimination. Even nowadays the calculus of lives saved would be huge (100k statistical lives a year is a breathtaking number on a population the scale of the US).
To deal with a few other tropes that have popped up in this thread now and again:
quote:Without the FDA, I'm not sure those "miracle drugs" would ever have existed in the first place, much less make it to the market sooner.
Why not? We have extraordinarily successful research programs in numerous areas.
quote:If you do invent a miracle drug, why should a doctor prescribe yours over the other dozens of drugs that claim to cure the same illness?
This doesn't make any sense at all. There are numerous professionals in numerous fields who somehow manage to deal with evolving techniques, procedures, and technologies without the government pre-approving, yet they aren't taken in by "snake oil" at any noticeable rate. What is it about doctors that will somehow lead them to be deluded en masse into failing to do research and learn which sources can be trusted and which cannot? Again, this will happen in some cases and for some doctors, but where's the evidence that it will happen to a huge degree leading to outweighing the huge numbers of lives saved each year by having drugs available more rapidly?
Also, I note that many defenders of the FDA as absolutely, indubitably necessary seem to also think that drug companies regularly put one over on the FDA right now. There seems to be at least a little cognitive dissonance going on.
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quote:The estimates you're seeing are around 100k statistical lives per year.
No the estimates I've found are 100 K lives, total since the 1960s. These were not statistical lives, they were defined in the same way you are defining it.
You still haven't given me a reference. Please, I want to know where these numbers are coming from.
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posted
Then I'm not sure where you're finding such estimates. Could you cite your study particularly the lack of using statistical lives as a measure of comparison?
You can find numerous estimates, both higher and lower than what I've described, in papers linked from this page: http://www.fdareview.org/harm.shtml You'll see mentioned even in the overview examples of drugs that would have saved tens of thousands of lives a year if deployed a few years earlier (and were in Europe, which had pre-approval, but with a shorter delay). It is hard to see how tens of thousands of lives a year (in those few cases where we have an effective lag for assessing the effect) can only become a a hundred thousand lives over several decades.
Oh, a reason for believing drug discovery might be better off in some ways without the FDA. Right now a drug will only be pursued with large amounts of resources for development if it stands a substantial chance of being a blockbuster drug profitable enough to make a huge profit in the years it is patented minus the years it awaits FDA approval. Take a few years off the timeline for drug approval, and suddenly the profitability margin drops by a substantial amount, encouraging new drug development.
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posted
Parkour, the people whom I have heard question whether asprin would be approved by modern standards were medical people. It was merely their opinion, though I give it some weight because of their backgrounds.
The Rabbit: Never mind.
fugu13, in the interest of crystal clarity, are you advocating that it would be better if the USFDA were abolished? That seems to be what you are saying. If so, then feel free to move to Mexico, or some other country in Latin America, where their standards for food and drugs are more lax. Somehow I do not see those countries as evincing greater health. Mexican doctors can treat you with laetrile, but I do not believe their cure rate for cancer is any greater than that of our doctors.
Having said that, I do still take exception to the practice of USFDA agents barging into health food stores and confiscating apricot seeds (from which laetril is derived), as they did frequently back in the 1970's. A friend of mine who operated a health food store actually had to defend himself in court for selling apricot seeds.
[ January 04, 2011, 04:37 PM: Message edited by: Ron Lambert ]
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