Ban the FDA

[natedogg]

John Stossel says it better than i could.

From: http://www.townhall.com/columnists/J...20050608.shtml

June 8, 2005

Last week, I wrote about a federal agency that most people think is indispensable. In reality, I said, the FDA regulates us to death, literally, by forbidding even dying Americans who can't be helped by established medical treatments from trying innovative therapies.

But what's the alternative? Have no oversight? Let any company peddle every dubious medicine to an unsuspecting public? That sounds terrifying. Snake-oil sellers would sell all kinds of harmful stuff. That's why we created the FDA in the first place.

But wait a second. Snake oil sellers sell it anyway. I've done consumer reports on snake-oil sellers for years. Crooks and deluded optimists sell useless baldness remedies, breast enlargers and diet products while the FDA is supposedly in charge. The FDA rarely stopped even the obvious crooks. What it mostly stopped, or delayed, were the serious drug companies' attempts at genuine innovations.

Without an FDA, how would doctors and patients know which drugs were safe and effective?

The same way we know which computers and restaurants are good -- through newspapers, magazines and word of mouth. In a free, open society, competition gets the information out, and that protects consumers better than government command and control.

Why must we give big government so much power? Couldn't FDA scrutiny be voluntary and advisory? Companies that want government blessing would go through the whole process and, after 10 or 15 years, get the FDA's seal of approval. Those of us who are cautious would take only FDA-approved drugs.

But if you had a terminal illness, you could try something that might save your life. You could try it without having to wait 15 years -- without having to break your country's laws to import it illegally from Europe -- without sneaking into Mexico to experiment in some dubious clinic. If I'm dying, shouldn't my government allow me the right to try whatever I want?

If FDA scrutiny were voluntary, the government agency would soon have competition. Private groups like Consumer Reports and Underwriters Laboratories (UL) might step in to compete with the FDA. The UL symbol is already on thousands of products. No government force was required. Yet even though UL certification is voluntary, its safety standards are so commonly accepted that most stores won't carry products without the UL symbol.

With such competition, the FDA might devise a ratings system ("general use," "medical guidance suggested," "patients strongly cautioned," or something like that), and drug packages would carry that information. We'd know that the government was evaluating new drugs, but government wouldn't stand between lifesaving treatments and us. Most of us, most of the time, would take the government's advice, but because it would be our choice, we could try new or risky drugs when nothing government-approved was available.

We could try a system where the FDA would review all drugs, but its approval wouldn't be needed for a drug to be sold. Private organizations might go into competition with the FDA even if its review remained mandatory. If a new drug is going to be "not yet rated" by the government for 15 years, the endorsement of an independent evaluator -- even one not quite as strict as the FDA -- that can deliver its opinion in three years would be valuable. Under today's FDA rule, consumers assume big government takes care of the whole issue, so we become less vigilant. The consumer is encouraged to stay asleep: Don't ask questions; just take what Big Brother approves. Yet, knowing what we know about the incompetence of government monopolies, there's little doubt that competing private groups would do the testing better, cheaper and quicker.

Any kind of FDA has its price. If all drugs have to be reviewed -- even if they can be sold while under review -- the cost in money and energy will keep some drugs off the market. But getting rid of the FDA's power to forbid us to try something would be a big improvement: It would mean Americans would no longer be forced to wait, and die while their government passes judgment on innovations that could save them.

[SheetWise]

There have been several "Orphan Drug" bills proposed, going back to (and promoted by) the Reagan administration. What they would do is relieve drug companies from any liability for the use of experimantal druga by terminally ill patients. Still seems like a no-brainer 20 years later, and the drug companies are for it.

[ACPlayer]

First you say this ---

[ QUOTE ]
What they would do is relieve drug companies from any liability for the use of experimantal druga

[/ QUOTE ]

then you say this ----

[ QUOTE ]
and the drug companies are for it.

[/ QUOTE ]


LMAO.

In fact if you deregulate the FDA to the point where the drug companies dont have to get approval, you MUST not give them exceptions from legal action for knowingly offering drugs that have significant side effects or for not doing proper due diligence. This is a significant balancing feature in our system

[coffeecrazy1]

Well...regardless...what do you think of Stossel's point?

[SheetWise]

ACPlayer -

If you are going to parse sentences when you quote somebody, please make an honest attempt to understand the complete thought first. At the very least, a preceding or following '...' will indicate to the reader that you personally felt qualified to edit the content without changing its meaning. Sadly, again, that is not the case.

You quote -
[ QUOTE ]
What they would do is relieve drug companies from any liability for the use of experimantal drugs

[/ QUOTE ]

What I wrote is -
[ QUOTE ]
What they would do is relieve drug companies from any liability for the use of experimantal drugs by terminally ill patients.

[/ QUOTE ]

I may be wrong. If you like, you can start a poll to see if any other readers feel the deleted portion was meaningful in understanding the quote.

You then respond -
[ QUOTE ]
In fact if you deregulate the FDA to the point where the drug companies dont have to get approval, you MUST not give them exceptions from legal action for knowingly offering drugs that have significant side effects or for not doing proper due diligence.

[/ QUOTE ]

Writing style and ambiguous subjects aside, I believe I can translate that -

"if you deregulate drug companies, you MUST not give exemptions from legal action for knowingly offering drugs that have undisclosed side effects."

Now, I've presented this as a translation -- not a quote -- so let me tell you what I did.

1) You wrote "deregulate the FDA". I assumed you meant deregulate the drug companies, since we don't deregulate Federal Agencies -- you see, it's Federal Agencies that do the regulating.

2) You wrote "to the point where the drug companies dont have to get approval". I just assumed that that's what deregulation meant, and that it was redundant. I think I'm right in the context of the original quote you're responding to (which includes the qualifier, terminally ill patients), I may be wrong in deleting this if you are responding to your revised version.

3) I changed your wording from "you MUST not give them exceptions" to "you MUST not give exemptions" simply because I wanted to understand the translation when I was done.

4) I changed the word "significant" to "undisclosed" for two reasons. One, most drugs approved by the FDA have significant side effects, but they are disclosed and currently limit liability -- so, that couldn't be what you meant. Two, you qualified the action of the drug companies by insering the word "knowingly", and limiting them to what was "knowingly significant" would create a conundrum of epoch proportion.

5) I removed the due diligence clause because of the word "knowingly" -- it was a toss-up which to remove, but clearly they can't both stand (for more information, see reason 4).

You then quote me -
[ QUOTE ]
and the drug companies are for it.

[/ QUOTE ]

The original was -
[ QUOTE ]
Still seems like a no-brainer 20 years later, and the drug companies are for it.

[/ QUOTE ]

That's pretty close. Of course, my point was that the drug companies would like to give experimental drugs to terminally ill patients -- which they currently don't do because of liability laws.

And don't let me forget to quote you -- I'll present it in its entirety --

[ QUOTE ]
LMAO.

[/ QUOTE ]

SheetWise

[lehighguy]

The FDA provides these companies with protections. So long as they pass FDA tests they can't get sued.

However, many of these companies would produce test data in spite of the FDA. In fact, you might say that companies would go a step further to make thier drugs saver since they can't use the "the FDA said if was ok" defense. They will constantly be subject to potential suits.

What getting rid of the FDA would really do is help people like my cousin. She has a very bad condition that requires the newest medicines to fight. Otherwise she would be a total cripple, maybe dead. Luckily my cousin has enough money to buy these drugs on the black market. The people hurt most by the FDA are dying poor people that aren't allowed to use drugs that can save thier lives.

[SheetWise]

[ QUOTE ]
The people hurt most by the FDA are dying poor people that aren't allowed to use drugs that can save their lives.

[/ QUOTE ]

Yeah, I know AC. LMAO [img]/images/graemlins/confused.gif[/img]

[superleeds]

[ QUOTE ]
Without an FDA, how would doctors and patients know which drugs were safe and effective?

The same way we know which computers and restaurants are good -- through newspapers, magazines and word of mouth

[/ QUOTE ]

You deserve to be poisoned if you think this is a reasonable way to regulate.

[ACPlayer]

I dont have a position on this subject.

In general I am not in favour of either giving big corporations too much freedom and am not in favour of burdensome regulation.

I just wanted to make the point that if we want the drug industry (or any other industry) to self regulate then they must also bear the financial consequences of negligent decisions.

[ACPlayer]

[ QUOTE ]
if you deregulate drug companies, you MUST not give exemptions from legal action for knowingly offering drugs that have undisclosed side effects.

[/ QUOTE ]

So, in all this parsing and semanticizing I missed whether you agree with this or not -- for terminally ill or otherwise. Of course it may be buried somewhere in there.