Aces High Bulletin Board
General Forums => The O' Club => Topic started by: miko2d on March 21, 2003, 01:30:58 PM
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Discussing liberty issues in general does not seem very productive on this boards. People get carried away, etc.
Let's discuss a very narrow issue.
Currently US Government prevents informed concenting adults from buying a product - medicine. There are two aspects of that.
First. A company cannot sell medicine unless it is approved by FDA.
Second, a person cannot buy some medicine unless it is prescribed by a licensed physician.
Both seem to violate our freedom to enter into voluntary contract based on personal preferences.
There may be a case made that safety of the product must be insured, but it can be easily solved by certification rather than licensing.
The drug still passes through the FDA certification process - though many products are certified by private organisations like Underwriter laboratories, etc. After that it can be sold with the stamp "Certified by FDA".
Untill that time, why shouldn't it be sold without such stamp or with a stamp "NOT certified by an FDA"?
Any adult realises that new products carry some risks and false labeling or false claims about the efficiency of a product hcan be handled by usual anti-fraud legislation.
People who are desperate would not have to wait for 15 years or get arbitrary approval from a government bureaucrat whether they are allowed to live by participating in the study.
All the consumers will benefit because while the drug is going through the FDA process, it will be also accumulating data based on the volunteers. Also, the drug company will get the return on it's investment so many years earlier which will drastically cut the cist of capital in the pharmaceutical business and hence make drugs more affordable and promote new research.
The rationale behind the licensing is that as customers we are too dumb to know what's good for us, so as voters we are making a smart choice to protect us from ourselves... Doesn't compute.
miko
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I forgot to mention that the government officials themselves would of course argue for licensing, since it gives them power.
Physicians would argue for it too since it gives them power and income.
Drug companies would argue for it too because FDA approval process is so expensive and takes so much time even in case of success and may end up in complete ban even if there is a category of people for whom benefits outweight the negative effects. That makes it practically impossible for a small company or a start-up to get into business and ensures monopoly for few huge companies with deep pockets.
The consumers and sick people get shafted, of course. And another liberty is taken away.
miko
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Once a company has its un-certified drug on the market, why would it bother to go the extra mile and finish the FDA approval process? As you said, that process is extremely expensive and risky. Better to sell an un-certified drug than take the risk of it failing the full FDA process.
ra
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Originally posted by miko2d
The rationale behind the licensing is that as customers we are too dumb to know what's good for us, so as voters we are making a smart choice to protect us from ourselves... Doesn't compute.
Centuries of quackery says otherwise.
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IMO, the FDA helps cut the crackpot companies out there that create stuff that either doesn't work or is just plain dangerous to use.
Should a person be able to use something that isn't FDA approved? ABSOLUTELY. However they (and family) should loose all rights to lawsuits if the products end up being unsafe or not doing what they are advertised to do.
If you don't want to wait for FDA approval, you assume all risks and loose all rights for monetary awards should something go wrong.
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What about drugs that turn out to be teratogenic?
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I know you Miko2d, you are trying to sneak in the first volley in the legalization of illegal drugs like heroin, cocaine, LSD and reefer :)
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yes , and the first time somebody died from a drug, miko would want a billion dollar "product liabilty' lawsuit against the "rich drug company"
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ra: Once a company has its un-certified drug on the market, why would it bother to go the extra mile and finish the FDA approval process?
Why all electric and electronic appliances companies bother to go through the UL approval process?
Who forces you to buy an un-certified drug? After all, if people want only certified drugs, the companies would have to go through the certification. If the people do not want to buy only the certifid drugs, then the law if bad, right?
Without the law, I can still buy the certified or refuse to buy the uncertified drugs but with the law, I am denied the choice.
As you said, that process is extremely expensive and risky.
So is paying the product liablity damage if your product proves defective or your claims false. The FDA process is not just for the formality of approval - but to test the effects.
How about the drug that passed the certification in another country? By a reputable university or hospital? Wouldn't the money wasted on multiple licensing in every country be better spent on research? Plenty of stuff is ligal in Europe but still awaining licensing in US.
Wouldn't many lives be saved by more drugs available?
Montezuma: Centuries of quackery says otherwise.
Sez you. Centuries of quackery did not persuade Founding Fathers to establish FDA. Humanity still survived and developed. You think the government control got rid of the quackery and abuse?
Or do you admit you are too stupid to not fall for a cracpot? Then why not sign your rights to a private warden or a guardian who will make those decisions for you. But leave me alone tod ecide for myself.
Modas: the FDA helps cut the crackpot companies out there that create stuff that either doesn't work or is just plain dangerous to use.
Which is certification part, not licensing. Also, why not let people to decide "dangerous" rather than have the same measure set by government? A guy with 6 month to live may worry much less about some side effect than a healthy person. A man may not care if the drug affects the pregnancy. Tens of thousands americans died waiting for approval of some drugs - on the authority of some bureaucrat. Isn't that too much power?
However they (and family) should loose all rights to lawsuits if the products end up being unsafe
You go way overboard with "all". With any products, you enter a contract. There are claims to the product efficiency and side effect. A buyer can sign any disclaimers the seller may want. Or not sighn and refuse the purchase. Why do you have to restrict the freedom of people in some way or another - if not what they can buy, than what kind of agreements they can enter? What business it is of yours?
Kisters: What about drugs that turn out to be teratogenic?
What about them? Don't buy the non-certified drugs.
Gunthr: I know you Miko2d, you are trying to sneak in the first volley in the legalization of illegal drugs like heroin, cocaine, LSD and reefer :)
That's why I tried to keep this topic very specific. :) I'd surely be willing to discuss that with you - start another thread if you care.
john9001: yes , and the first time somebody died from a drug, miko would want a billion dollar "product liabilty' lawsuit against the "rich drug company"
So? The jury would take a look what the company claimed and what I signed while buying it and decide if the case has merit. Same as with any product. Same as signing a concent form when getting medical treatment. It means that you accept the inherent risks - but still allows you to sue for malpractice.
You cannot base the legislation on the premise that our legal system is flawed. If it were, why not fixt it in the first place?
What if I go abroad and buy that drug in another country where it is approved - and then sue the same company? Would it be fair, john9001? A rich man can do that easily but a poor man would die waiting for teh life-saving drug or procedure. As usual.
Or should not only the companies be forbidden to sell unlicensed drugs in the US but US citizens be forbidden to buy non-FDA approved drugs - even outside US? That woudl be logical. And there is a precedent - In 1933 US citizens were forbidden to own gold, and later they were forbidden to own gold even outside the country - untill 1975. Why not do the same with drugs - after all, they may hurt themselves, right?
miko
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I swear, you are one of the dumbest people I have the pleasure of not knowing.
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If the people do not want to buy only the certifid drugs, then the law if bad, right?
I still don't see why a pharmaceutical company would bother certifying their drugs. You can get the drug on the market years faster and cheaper if it's uncertified. It would be cheaper for the consumers, too. So the rest of the FDA process would be very unattractive. And if an uncertified drug works, no one would care if it goes through the rest of the FDA approval process.
ra
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Originally posted by Martlet
I swear, you are one of the dumbest people I have the pleasure of not knowing.
You may not like him, but Miko2d is certainly not stupid.
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Originally posted by Furious
You may not like him, but Miko2d is certainly not stupid.
I disagree.
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A couple points.
1: Most people don't have a clue what most medicines are for, or why they are taking them. I say this from over 10 years of working in EMS. Medicines are perscribed because the MD, PA,FNP knows that this particular med is better for a particular type of problem. (ie. In order to reduce the preload/ afterload and myocardial oxygen demand of a diseased or damaged heart it is much better to use a beta blocker than an Angiotension converting enzyme inhibitor. ) The general public know these two classes of drugs as "blood pressure pills", and dont have a clue what the side effects are or the interactions with other drugs. For exampel: If that same person with the bad heart has angina, takes nitroglycerine and wants to take Viagra so he and his secratery can have some fun, then he needs to know he can not under any circumstances take the nitro for several hours after the viagra and needs to be switched from a beta blocker to perhaps a clacium channel blocker to avoid a severe and prolonged period of hypotension (severe low blood pressure, you need a systolic pressure of at least 65-70 to perfuse (circulate blood to) the brain.
2: People have shown that if they can get them they will abuse narcotics, both class 2 and class 3.
3: Not every drug that is studied by the FDA is approved and makes it to the market. Not even close. Would you want to take a drug because the company that makes it says it does something and has no side affects? That company has everything to gain from selling that drug and might not want to put the $ into researching the side effects, contraindications, indications, interactions ect.
4: pharmicology is a very complex and compicated subject that goes way beond take two asprin and call me in the morning. Did you know that one of the most lethal drugs out there (when taken on large quantities ie overdose) is acetamenaphin (tylonol)? It will destroy your liver and you will die a slow and very painful death.
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Originally posted by miko2d
[BKisters: What about drugs that turn out to be teratogenic?
What about them? Don't buy the non-certified drugs.
[/B]
Babies born with drug induced malformities wouldnt exactly get the option of not buying non-certified drugs.
patients/population wouldnt know about which drugs pose this kind of risk or not.
Sorry for bad english.
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What a stupid topic at this time. Lets legalize free access to narcotics. Yeah.....give me 500 percocet to go, thanks. :)
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Originally posted by miko2d
Or do you admit you are too stupid to not fall for a cracpot? Then why not sign your rights to a private warden or a guardian who will make those decisions for you. But leave me alone tod ecide for myself.
miko
If the FDA is stopping you from getting that tiger noodle you want, go to some other country.
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well actually, miko wants to sell you the tiger noodle crap himself.. why let that buisness go overseas? of course he wants to sell that stuff to you without government intervention, controls or interference from folks like doctors or lawyers.
as a libertarian, his concept of america is in theory, quite exciting.... in a rabid no holds barred capitalistic, serf/overlord, private corporate police sort of way.
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ra: I still don't see why a pharmaceutical company would bother certifying their drugs. You can get the drug on the market years faster and cheaper if it's uncertified.
Certification is basically some organisation with a lot of reputation vouching for the qualities of the product. Since a lot if not most value of a company depends on it's reputation, businesses in all industries try to protect it. you lose reutation - you are dead. Just look what happened to Arthur Andersen!
So I would be perfectly fine if a large old company with great reputation like Phizer tested it's own products. If a company is new and unkown, it would need someone reputable to underwrite it - like FDA or maybe The Mayo Clinic or Harward Medical Center or whatever. Plenty of companies do business testing and underwriting products for another companies, taking the burden of research from the customer. The most common example is a department store. You buy products based on the store reputation. Store tries to preserve and improve it's reputation, so it does not sell crappy products.
Basically, there are quite a lot free-market mechanism to ensure quality without direct governmental control and in most products it works just fine. It would not be cheaper for a manufacturer to sell a crappy product - a car, a rifle, a medicine, period.
Martlet: I swear, you are one of the dumbest people I have the pleasure of not knowing.
That may well be true - but if you are basing that opinion on this thread, you are the dumb and ignorant one. What, you tought that it was my idea? I wish. Not only Founding Fathers did not think state licensing of products necessary, such brilliant economists and nobel prise winners as Hayek and Friedman convincingly prove that such licensing not onlyviolates basic freedom of entering into contracts but hurts both consumers and producers economically and limits availability of drugs - or any other product.
medicboy: Most people don't have a clue what most medicines are for, or why they are taking them.
That's why we go to the doctors. Most people do not know how TV works or digestive tract or a car engine.
People have shown that if they can get them they will abuse narcotics...
So? If they want to do that intentionally, who am I to argue? And why should I be denied a choice because someone is dumb?
Would you want to take a drug because the company that makes it says it does something and has no side affects?
If it's a reputable company, sure. If they said they did thoriugh testing and did not, well - they will be liable for any damages, like any other product.
Did you know that one of the most lethal drugs out there (when taken on large quantities ie overdose) is acetamenaphin (tylonol)? It will destroy your liver and you will die a slow and very painful death.
And yet many people happily use a lot of it because it's "FDA approved" and they do not feel the need to think about it.
Babies born with drug induced malformities wouldnt exactly get the option of not buying non-certified drugs.
Babies or children would not get an option to make any decisions - parents do that untill they reach legal age. What if a parent decides to move into a tornado-prone area? Buy an unsafe car? Feed them the "wrong" food? Children are parent's responcibility. If you limit once choice of prospective parents, why not all? Incaarcerate all pregnant women at conception so they cannot hurt the fetus, then take childern away from parents at birth so they grow in approved environment, right?
Hangtime: well actually, miko wants to sell you the tiger noodle crap himself
Actually I sell software. It is not licensed or even certified by anyone - just backed by my reputation and the contract. What's teh problem if someone sells tiger noodlees? As long as it's really what it says on teh package and no false untested claims are made - why would anyone care?
As for "no holds barred", I never said I want to deprive you of FDA. Let it certify products, so you - and any who agree with you - can buy only those products.
miko
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Yeah get rid of the FDA - and while you're at it, you could also get rid of FAA regs - they are too expensive to comply with and prevent start up companies - we can just have certified airlines and non certified airlines with certified and non certified pilots - it's up to you if you want to fly with the non certified pilot. That would put airfares down and bring new pilots to the market much more quickly. We could extend it safety regs in cars, electrical appliances, etc etc.
Sadly Miko's plan of certification wouldn't work - it's based on some flawed assumptions:
1. He tacitly assumes that FDA regulations would be sought after even though they are unnecessary to sell the product. Perhaps he feels drug companies' primary function is to make drugs to heal people. Sadly it's not - their primary function is to make money. Everything else is secondary. If they could sell a drug without FDA approval, that would be the end of FDA approval - no new drug would ever be offered for approval.
2. He also assumes that without FDA testing, the drug's effects, side effects (especially long-term side effects), contraindications, and interactions would be magically known by the drug company. The FDA testing is not just a cumbersome 15-year long rubber stamp, it does actually test stuff.
Also it leaves out a question:
If a drug were to fail FDA approval - would it still be available for sale with the uncertified label?
As to prescriptions - they primarily enforce a degree of medical supervision while taking dangerous drugs. This serves in several ways:
1. Dangerous side effects can be avoided - with medical supervision these can be spotted, recorded and the drug changed to something that doesn't produce such dangerous side effects.
2. Use of contraindicated drugs is avoided - stops the patient using the wrong drugs - ie drugs that are correct for the disease but no good for them. Thalidomide during pregnancy for example.
3. It also avoids known drug interactions - the doctor is more likely to know about drug interaction effects, and therefore avoid prescribing two drugs that go badly together.
4. Patient education - the doctor gets a chance to tell the patient about the drug - dos and don'ts.
5. It also helps restrict the supply of antibiotics, which goes some way to slowing the the spread resistant strains. If they went free for all you could welcome back quite a few diseases into the fatal circle - pneumonia, tuberculosis, syphilis etc.
Sure it also restricts fun drugs - heroin, lsd, cocaine, ecstasy, speed - they were all invented by pharmaceutical companies - "Heroin" is actually Bayer's tradename for the drug - the scientific name is diacetylmorphine.
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About "Darwinism" all the time.....legalize all drugs, it will save Ashcroft the trouble of setting up the Endgültige Lösung you pray for.
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miko2D,
Fear not, you're wish is already coming true. The pharmacetical companies have noticed that the "natural suplements" industry doesn't have to get it's stuff tested or it's claims verified by the FDA. Many of the pharmacetical companies are investigating the possiblity of bypassing the annoying FDA approval process by selling their drugs as "suplements".
Yay. No accountability and no supervision. Won't it be great!!!!
:rolleyes:
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Without getting into why it is so utterly essential in regard to pharmaceuticals, the american agriculture and food comerce aparatus is the envy of the world largely due to the activities of the FDA. My only gripe is that alcohol and tobacco should be regulated by the FDA, not the ATF. Now there is a beuracracy that I would like to see die .
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quote__________
However they (and family) should loose all rights to lawsuits if the products end up being unsafe or not doing what they are advertised to do.
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completely stupid idea, would be much smarter to let the companies who went the extra mile (and got their drugs certified) off the hook from law suits.
why would any company spend the millions to be certified (not to mention lost sales while they wait out the process) so that they can earn the right to be sued for product liability
if you follow the recomended dose and indications for aplication, on a product and it does you harm you should have the right to seek damages.
however if you aren't smart enough to follow the directions or at least recognise when you are in over your head and need to seek an expert opinion, then you should have no recorse in the courts.
but with the curent shortage of healthcare providers and rising medical costs I should, as an adult, be able to us my best judgement and decide if I need to seek advice or if I just need the medication. if I'm mis-diagnose myself or OD, the manufacture should face no liability for that.
here is one example- I get small 3rd degree burns often at work (almost daily), there is a perscription cream that is very inexpensive that works wonders for preventing infection and promoting healing (silvadene {SP?}). after 15 years of this work I know how to treat a burn. and I know when it's not healing properly or the damage is to deep or in critical areas, and in need of profesional treatment. why should I have to waste a DR.'s time and my money to get the medicine I already know I need?
as it is I have to either let the burns scar and increase the risk of infection, or miss a day of work and pay for a DR visit a couple times a year to get a new perscription. sometimes you can get them to write you a year of refills so you are only out an aditional $300-400 a year(for a lost day of work + a DR visit) in addition to the price of the meds you already knew you needed before you went to the DR.
however, if I the product I knew worked was un available and I used another medicine that advertised that it would work, and I followed the directions. then had side effects that where not mentioned on the lable I should have recorse in the courts. nobody should be given a free ticket to defraud others, and that is what imunity from litigation is.
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The FDA started regulating the pharmaceutical industry only after the industry demonstrated it couldn’t/wouldn’t adequately regulate itself.
In the 1930s, a sulfa drug contaminated with diethylene glycol (a toxic solvent) killed 107 people, many who were children, and the public demanded something be done. Congress passed the Food Drug and Cosmetic Act requiring manufacturers prove their products are relatively safe before selling them.
In the 1960s, the sleeping pill thalidomide was found to have caused thousands of birth defects in European children. Recognition of role the FDA played in keeping this drug off U.S. market increased the public’s support for stronger drug regulations. This led to an amendment that required manufacturers to also prove their product was effective.
In short, history has shown that is impossible for a patient to determine if a particular drug is safe or effective. So before a manufacturer gets to make money on a drug, they have to show that it is safe and actually works.