Liberty issue - medicine.

[miko2d]

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

[miko2d]

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

[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?  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

[Montezuma]

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.

[Modas]

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.

[Kisters]

What about drugs that turn out to be teratogenic?

[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

[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"

[miko2d]

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

[Martlet]

I swear, you are one of the dumbest people I have the pleasure of not knowing.

[ra]

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

[Furious]

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.

[Martlet]

Originally posted by Furious
You may not like him, but Miko2d is certainly not stupid.

I disagree.

[medicboy]

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.

[Kisters]

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.