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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Thu Apr 17, 2008 12:56 am 
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punkdavid wrote:
B wrote:
I'm against the death penalty, but even I don't think lethal injection is unconstitutional.

But is the particular way they do it "cruel and unusual punishment"? This 3 drug "cocktail" takes several minutes to administer, and has had some notably awful fuckups in the past few years (I seem to remember a couple in Florida). Check the other threads for thsoe accounts, I know we discussed them here.

When we put our cat down it was a shot of sedative, and then the death shot. The whole thing took 30 seconds, and there was quite obviously no pain. Why they can't do that is beyond me.


I don't think the incompetence of government employees makes it unconstitutional. I'm appalled that the society I live in deems the death penalty tolerable at all, but once you say that you can kill people, then you do it, and when someone fucks it up, you fire them and get someone else to do it.

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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Mon Apr 21, 2008 1:20 am 
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http://news.yahoo.com/s/afp/20080326/ts_alt_afp/usmexicojusticecourticj;_ylt=AiUZTZRWxrH.uGmYLOfCcaBMEP0E

Quote:
Supreme Court says US states can ignore ICJ rulings

WASHINGTON (AFP) - US state courts need not comply with International Court of Justice (ICJ) decisions, even if the US president orders them to, the US Supreme Court ruled Tuesday in the case of a Mexican sentenced to death.

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The Hague-based ICJ on March 2004 ordered trial revisions in the United States of 51 Mexicans sentenced to death, because they had not been timely informed of their right to consular assistance.

One of them, 33-year-old Jose Medellin -- convicted of raping and murdering two teenagers in Texas in 1993 -- demanded Texas courts acknowledge that the omission pointed out by the ICJ warranted a retrial.

President George W. Bush, exercising his prerrogative in applying international treaties, ordered state judges to determine, on a case-by-case basis, whether any of the 51 Mexicans merited a retrial.

While some states complied with his order, Texas judges refused to examine Medellin's appeal on grounds they were not bound by ICJ decisions nor by presidential orders on the principle of separation of powers.

The Supreme Court ruled six to three in favor of Texas' magistrates.

"We conclude that neither (the ICJ) nor the president's memorandum constitutes directly enforceable federal law that pre-empts state limitations," Supreme Court Chief Justice John Roberts said in the court's opinion.

Bush "has an array of political and diplomatic means available to enforce international obligations, but unilaterally converting a non-self-executing treaty into a self-executing one is not among them," he added.

"We're disappointed with the decision," said White House spokeswoman Dana Perino.

She stressed however that US arguments in the case "in no way condoned or defended the heinous crimes of which Jose Medellin was convicted."

The Bush administration had from the start criticized the International Court of Justice trial revision ruling, and later it withdrew from the ICJ treaty it had supported to avoid similar appeals.

"The Supreme Court recognized that there was an international obligation to comply with a legally ratified treaty of the United States. But their point was that the president of the United States does not have the authority, under current law, to compel a state to act," Perino said.

The Mexican Foreign Ministry called for compliance with the ICJ ruling.

"The government of Mexico considers that the rulings of the International Court of Justice should be respected by states that have accepted (the court's) jurisdiction," it said in a statement.

The People for the American Way Foundation said called the Supreme Court's ruling a "deeply troubling opinion ... signaling that the United States can simply ignore its obligations under international treaties."

"We can and must enforce our laws and defend our borders without abandoning the treaties we have signed," the group added in a statement.


Was the ICJ agreement ratified by congress?


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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Mon May 19, 2008 7:00 pm 
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Supreme Court upholds part of anti-child porn law

There's nothing in this article that makes me worry about the stuff that Souter and Ginsberg are worried about. I guess if I saw that law, I might get it, but I don't really have a problem with this opinion.

I hate agreeing with Scalia and Thomas. :evil:

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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Mon May 19, 2008 10:57 pm 
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Wyeth v. Levine (unscheduled)

The Supremes have agreed to hear a case that some lawyers believe will resolve the fracas over preemption - a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

This scares the shit out of me. If the republicans get their way then once the FDA approves a drug then it is automatically deemed to be safe. There will no longer be a way to hold the pharmaceutical companies accountable and they will become immune from lawsuits.

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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Mon May 19, 2008 11:51 pm 
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PJ10alive41 wrote:
Wyeth v. Levine (unscheduled)

The Supremes have agreed to hear a case that some lawyers believe will resolve the fracas over preemption - a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

This scares the shit out of me. If the republicans get their way then once the FDA approves a drug then it is automatically deemed to be safe. There will no longer be a way to hold the pharmaceutical companies accountable and they will become immune from lawsuits.


I'd rather see the FDA approve drugs that are not unsafe. I don't think you should be able to sue a manufacturer if the FDA reviewed the info and found it safe. If the FDA missed information, you should either be able to sue the FDA or the company for not disclosing the information.

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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 12:18 am 
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B wrote:
PJ10alive41 wrote:
Wyeth v. Levine (unscheduled)

The Supremes have agreed to hear a case that some lawyers believe will resolve the fracas over preemption - a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

This scares the shit out of me. If the republicans get their way then once the FDA approves a drug then it is automatically deemed to be safe. There will no longer be a way to hold the pharmaceutical companies accountable and they will become immune from lawsuits.


I'd rather see the FDA approve drugs that are not unsafe. I don't think you should be able to sue a manufacturer if the FDA reviewed the info and found it safe. If the FDA missed information, you should either be able to sue the FDA or the company for not disclosing the information.

I would think that this ruling would be a very narrow one. I'm one of those people who feel that the FDA review process is exceedingly thorough, and there is no state that has the capability to do what the FDA does. These "state guidelines" that are being used must be exceedingly amorphous.

A couple of issues peculiar to this case make me wonder how the case got to the Supreme Court in the first place.

1. First, phenergan is safe when properly administered via IV push. The problem was that the IV was opened in an artery, not a vein. That was why Levine developed gangrene and lost her arm.

2. The packaging clearly stated that one of the complications of improper administration of the drug through an arterial line was gangrene. This would be true of a large number of drugs, not just phenergan.

3. Levine already settled with the care providers. It was their improper administration of the drug that lead to her condition. She settled with them, probably because she wouldn't have won a suit. The standard for medical malpractice is not a complete lack of error. If care providers are providing appropriate care to the best of their abilities, then no malpractice has been committed even if mistakes are made during the course of care.


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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 12:47 am 
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B wrote:
PJ10alive41 wrote:
Wyeth v. Levine (unscheduled)

The Supremes have agreed to hear a case that some lawyers believe will resolve the fracas over preemption - a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

This scares the shit out of me. If the republicans get their way then once the FDA approves a drug then it is automatically deemed to be safe. There will no longer be a way to hold the pharmaceutical companies accountable and they will become immune from lawsuits.


I'd rather see the FDA approve drugs that are not unsafe. I don't think you should be able to sue a manufacturer if the FDA reviewed the info and found it safe. If the FDA missed information, you should either be able to sue the FDA or the company for not disclosing the information.

The problem is that the FDA, like all organizations comprised of humans, make mistakes.


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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 12:58 am 
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Green Habit wrote:
B wrote:
PJ10alive41 wrote:
Wyeth v. Levine (unscheduled)

The Supremes have agreed to hear a case that some lawyers believe will resolve the fracas over preemption - a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

This scares the shit out of me. If the republicans get their way then once the FDA approves a drug then it is automatically deemed to be safe. There will no longer be a way to hold the pharmaceutical companies accountable and they will become immune from lawsuits.


I'd rather see the FDA approve drugs that are not unsafe. I don't think you should be able to sue a manufacturer if the FDA reviewed the info and found it safe. If the FDA missed information, you should either be able to sue the FDA or the company for not disclosing the information.

The problem is that the FDA, like all organizations comprised of humans, make mistakes.

That's why FDA approval isn't contingent on a group of beaurocrats. The FDA convenes panels of both intramural and extramural experts in the field to evaluate all of the primary data and make recommendations. All of this occurs following approval by Institutional Review Boards at all three phases of a drug trial. Generally, the complaints are that FDA approval is too slow in coming, rather than too rapid and too careless. In cases in which mistakes have been made, significant information was withheld from the FDA (Phen-phen) and/or the drugs were used in inappropriate populations (Vioxx). And in this particular case, no one is claiming that phenergan, the drug in question is unsafe or lacking in efficacy. The case involves complaints about packaging that are mystifying to me.

Once a drug is released into the population the FDA continues to monitor adverse event reporting resulting in the withdrawing of drugs that have adverse effects outside the study populations (Rotarix).


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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 1:00 am 
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Green Habit wrote:
B wrote:
PJ10alive41 wrote:
Wyeth v. Levine (unscheduled)

The Supremes have agreed to hear a case that some lawyers believe will resolve the fracas over preemption - a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

This scares the shit out of me. If the republicans get their way then once the FDA approves a drug then it is automatically deemed to be safe. There will no longer be a way to hold the pharmaceutical companies accountable and they will become immune from lawsuits.


I'd rather see the FDA approve drugs that are not unsafe. I don't think you should be able to sue a manufacturer if the FDA reviewed the info and found it safe. If the FDA missed information, you should either be able to sue the FDA or the company for not disclosing the information.

The problem is that the FDA, like all organizations comprised of humans, make mistakes.


Then THAT's who you sue. The people who told you it was safe but fucked up. Or you establish a fund like the National Vaccine Injury Compensation Program.

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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 1:14 am 
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B wrote:
Green Habit wrote:
B wrote:
PJ10alive41 wrote:
Wyeth v. Levine (unscheduled)

The Supremes have agreed to hear a case that some lawyers believe will resolve the fracas over preemption - a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

This scares the shit out of me. If the republicans get their way then once the FDA approves a drug then it is automatically deemed to be safe. There will no longer be a way to hold the pharmaceutical companies accountable and they will become immune from lawsuits.


I'd rather see the FDA approve drugs that are not unsafe. I don't think you should be able to sue a manufacturer if the FDA reviewed the info and found it safe. If the FDA missed information, you should either be able to sue the FDA or the company for not disclosing the information.

The problem is that the FDA, like all organizations comprised of humans, make mistakes.


Then THAT's who you sue. The people who told you it was safe but fucked up. Or you establish a fund like the National Vaccine Injury Compensation Program.

No one ever tells you that any drug is 100% safe in any context. It wouldn't be a bioactive agent if that were the case. But what if it were deemed safe in the approved context, but not safe if someone fucks up the administration of it? What then?


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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 1:26 am 
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SLH916 wrote:
B wrote:
Green Habit wrote:
B wrote:
PJ10alive41 wrote:
Wyeth v. Levine (unscheduled)

The Supremes have agreed to hear a case that some lawyers believe will resolve the fracas over preemption - a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

This scares the shit out of me. If the republicans get their way then once the FDA approves a drug then it is automatically deemed to be safe. There will no longer be a way to hold the pharmaceutical companies accountable and they will become immune from lawsuits.


I'd rather see the FDA approve drugs that are not unsafe. I don't think you should be able to sue a manufacturer if the FDA reviewed the info and found it safe. If the FDA missed information, you should either be able to sue the FDA or the company for not disclosing the information.

The problem is that the FDA, like all organizations comprised of humans, make mistakes.


Then THAT's who you sue. The people who told you it was safe but fucked up. Or you establish a fund like the National Vaccine Injury Compensation Program.

No one ever tells you that any drug is 100% safe in any context. It wouldn't be a bioactive agent if that were the case. But what if it were deemed safe in the approved context, but not safe if someone fucks up the administration of it? What then?


Is it a stated risk?

Yes? Tough break.

No? Then who fucked up the administration? it's either a doctor or yourself.

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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 1:32 am 
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B wrote:
SLH916 wrote:
B wrote:
Green Habit wrote:
B wrote:
PJ10alive41 wrote:
Wyeth v. Levine (unscheduled)

The Supremes have agreed to hear a case that some lawyers believe will resolve the fracas over preemption - a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

This scares the shit out of me. If the republicans get their way then once the FDA approves a drug then it is automatically deemed to be safe. There will no longer be a way to hold the pharmaceutical companies accountable and they will become immune from lawsuits.


I'd rather see the FDA approve drugs that are not unsafe. I don't think you should be able to sue a manufacturer if the FDA reviewed the info and found it safe. If the FDA missed information, you should either be able to sue the FDA or the company for not disclosing the information.

The problem is that the FDA, like all organizations comprised of humans, make mistakes.


Then THAT's who you sue. The people who told you it was safe but fucked up. Or you establish a fund like the National Vaccine Injury Compensation Program.

No one ever tells you that any drug is 100% safe in any context. It wouldn't be a bioactive agent if that were the case. But what if it were deemed safe in the approved context, but not safe if someone fucks up the administration of it? What then?


Is it a stated risk?

Yes? Tough break.

No? Then who fucked up the administration? it's either a doctor or yourself.

Well, that's my problem with Levine's suit. The risk of gangrene following improper administration is clearly stated on the packaging. Her doctors improperly administered it. She sued them, and has already settled with them. Her complaint is that the risk is not prominant enough stated on the packaging. I say that as sorry as I feel for her, this suit is ridiculous.


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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 2:16 am 
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B wrote:
Green Habit wrote:
B wrote:
PJ10alive41 wrote:
Wyeth v. Levine (unscheduled)

The Supremes have agreed to hear a case that some lawyers believe will resolve the fracas over preemption - a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

This scares the shit out of me. If the republicans get their way then once the FDA approves a drug then it is automatically deemed to be safe. There will no longer be a way to hold the pharmaceutical companies accountable and they will become immune from lawsuits.


I'd rather see the FDA approve drugs that are not unsafe. I don't think you should be able to sue a manufacturer if the FDA reviewed the info and found it safe. If the FDA missed information, you should either be able to sue the FDA or the company for not disclosing the information.

The problem is that the FDA, like all organizations comprised of humans, make mistakes.

Then THAT's who you sue. The people who told you it was safe but fucked up. Or you establish a fund like the National Vaccine Injury Compensation Program.

Well, if I were running things, I wouldn't require FDA approval to allow a drug to hit the market. In that scenario, you either consume at your own informed risk, or if you were fraudulently misled by the maker of the drug, you can sue them.

This is also reason #92 why I could never be elected to public office. :)


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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 2:24 am 
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Green Habit wrote:
B wrote:
Green Habit wrote:
B wrote:
PJ10alive41 wrote:
Wyeth v. Levine (unscheduled)

The Supremes have agreed to hear a case that some lawyers believe will resolve the fracas over preemption - a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

This scares the shit out of me. If the republicans get their way then once the FDA approves a drug then it is automatically deemed to be safe. There will no longer be a way to hold the pharmaceutical companies accountable and they will become immune from lawsuits.


I'd rather see the FDA approve drugs that are not unsafe. I don't think you should be able to sue a manufacturer if the FDA reviewed the info and found it safe. If the FDA missed information, you should either be able to sue the FDA or the company for not disclosing the information.

The problem is that the FDA, like all organizations comprised of humans, make mistakes.

Then THAT's who you sue. The people who told you it was safe but fucked up. Or you establish a fund like the National Vaccine Injury Compensation Program.

Well, if I were running things, I wouldn't require FDA approval to allow a drug to hit the market. In that scenario, you either consume at your own informed risk, or if you were fraudulently misled by the maker of the drug, you can sue them.

This is also reason #92 why I could never be elected to public office. :)

You can't determine, safety, efficacy or dosing without trials. Without the FDA framework, how would you set that up? There has to be consistency or no one would know whether any drugs actually worked or were safe. We might as well all go back to barbers for our medical care.


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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 2:34 am 
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SLH916 wrote:
You can't determine, safety, efficacy or dosing without trials. Without the FDA framework, how would you set that up? There has to be consistency or no one would know whether any drugs actually worked or were safe. We might as well all go back to barbers for our medical care.

We may be drifting a bit off topic, but I'll re-post the argument that John Stossel made that I posted in another thread:

viewtopic.php?f=7&t=69334&p=1996556#p1996556

John Stossel wrote:
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.


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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 2:47 am 
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Green Habit wrote:
SLH916 wrote:
You can't determine, safety, efficacy or dosing without trials. Without the FDA framework, how would you set that up? There has to be consistency or no one would know whether any drugs actually worked or were safe. We might as well all go back to barbers for our medical care.

We may be drifting a bit off topic, but I'll re-post the argument that John Stossel made that I posted in another thread:

viewtopic.php?f=7&t=69334&p=1996556#p1996556

John Stossel wrote:
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.

Green Habit, I have a lot of respect for you, but the idea of Consumer Reports having the capability to conduct drug trials is beyond ludicrous. Here in the US we have the possibility for many choices in drugs that do similar things. All of these were approved after multi-phase trials. Even then the number of choices is dizzying. Do you want to add to your choice of 24 different antibiotics that cover the same thing, more drugs that some company, somewhere, tells you are also effective? Remember drugs are bioactive agents. Digitalis can save a life, but if given in a high enough dose, it can kill.

Drugs must be tested first for safety in extremely resilient populations, then safety in at-risk populations, then for efficacy in resilient populations, then efficacy in at-risk populations. Most drugs never make it through these trials, and individuals who in life-or-death situations are given special dispensation to try experimental drugs. I've seen trials go bad and people die. Do you want to make yourself the test case?

John Stossel doesn't know what the fuck he is talking about. There's a reason that the FDA exists. Think of the patchwork of lawsuits that would arise if drugs came on the market tested only in tissue culture.


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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 3:11 am 
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SLH916 wrote:
Green Habit wrote:
SLH916 wrote:
You can't determine, safety, efficacy or dosing without trials. Without the FDA framework, how would you set that up? There has to be consistency or no one would know whether any drugs actually worked or were safe. We might as well all go back to barbers for our medical care.

We may be drifting a bit off topic, but I'll re-post the argument that John Stossel made that I posted in another thread:

viewtopic.php?f=7&t=69334&p=1996556#p1996556

John Stossel wrote:
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.

Green Habit, I have a lot of respect for you, but the idea of Consumer Reports having the capability to conduct drug trials is beyond ludicrous. Here in the US we have the possibility for many choices in drugs that do similar things. All of these were approved after multi-phase trials. Even then the number of choices is dizzying. Do you want to add to your choice of 24 different antibiotics that cover the same thing, more drugs that some company, somewhere, tells you are also effective? Remember drugs are bioactive agents. Digitalis can save a life, but if given in a high enough dose, it can kill.

Drugs must be tested first for safety in extremely resilient populations, then safety in at-risk populations, then for efficacy in resilient populations, then efficacy in at-risk populations. Most drugs never make it through these trials, and individuals who in life-or-death situations are given special dispensation to try experimental drugs. I've seen trials go bad and people die. Do you want to make yourself the test case?

John Stossel doesn't know what the fuck he is talking about. There's a reason that the FDA exists. Think of the patchwork of lawsuits that would arise if drugs came on the market tested only in tissue culture.

A couple addenda:

First, I would not go as far as to instantly dissolve the FDA, and I would imagine that the FDA would remain the dominant source of information for a long time until other avenues could be well established and trusted.

Second, the drug makers have a very serious incentive to not harm their customers, because the public relations, lawsuits, prosecutions, etc. would be absolutely devastating otherwise.


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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 3:33 am 
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I don't give a fuck about the actual facts in Wyeth v. Levine. My issue is that this case has the potential to be the biggest tort reform bullshit we have seen in quite some time. The companies conduct their own research and the FDA approves the labeling. Take Ortho-Evra for example...Johnson and Johnson release the drug after conducting 3 tests. However, they only publish 2 tests to the FDA because that's all they require. Since the tests were conflicting (one test showed that the birth control patch was just as safe as the pill and the other test showed it posed a 2 fold increase in blood clots), the drug was advertised as a safe alternative to the pill. However, now we have 16-25 year old girls with PE's, strokes, heart attacks and DVTs. In turn, J&J gets flooded with a wave of lawsuits...so what do they do? They release the 3rd test that confirms the patch doubles the propensity of blood clots. The bastards knew about the 3 tests from the start, but they only released the 2. So now after the lawsuits, the FDA revises the labeling to warn of the increased risk.

Who fucked up here? The FDA? No, J&J fucked up by concealing the fact that they KNEW the 3rd test existed.

If the Supremes rule in favor of preemption there will be no more lawsuits. There will be no more accountability. There will be no incentive to revise labeling. There will only be billion dollar corporations filling their pockets while the average consumer suffers from the consequences of their negligence.

Fuck Republicans.

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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 4:08 am 
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Green Habit wrote:
A couple addenda:

First, I would not go as far as to instantly dissolve the FDA, and I would imagine that the FDA would remain the dominant source of information for a long time until other avenues could be well established and trusted.

Second, the drug makers have a very serious incentive to not harm their customers, because the public relations, lawsuits, prosecutions, etc. would be absolutely devastating otherwise.

The drug makers already have an incentive not to harm their patients, but they have very little incentive to provide maximum efficacy for the cost. The vast majority of funds that are used to conduct drug trials come from the US Government, contingent on both IRB and FDA approval. This is the best protection for study volunteers. No drug company has the capability to conduct trials without a multicenter effort coordinated with both national regulatory agencies and hospital-based testing sites. Do you think that any individual drug company could replace the function of the FDA for oversight? What you are advocating would be a by-passing of the trials network and sending drugs out to be tested in situ. There is no way for any drug company to know whether a drug is potentially harmful without Phase I trials. Who would coordinate this?


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 Post subject: Re: The Supreme Court Decision Discussion Thread
PostPosted: Tue May 20, 2008 4:34 am 
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Green Habit wrote:
drug makers have a very serious incentive to not harm their customers, because the public relations, lawsuits, prosecutions, etc. would be absolutely devastating otherwise.


Again...the reason I mentioned this case...there is a very real possibility that these consequences will no longer be incentives. FDA approval could mean that the drug companies are immune to litigation.

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