[Stoner]

This post has, in one sense, no connection to the Patriot Act, but everything to do with the government control of a citizens right's.
So, the question becomes,IMO, should lobbyists be legislating our liberties.

Here's linkage to oil lobbying :
http://www.publicintegrity.org/oil/report.aspx?aid=345

Here's linkage to pharmaceutical :
http://www.commondreams.org/news2002/0613-04.htm

Here's linkage to the AMA spending:
http://www.managedcaremag.com/archiv...news_ama.shtml

IMO, It took only one 'lobbyist' representing the oil industry to get this country involved in a religious war, but obviously, considerable spending to put him in the vice president's chair.

Now there is the restriction to prevent the public from defending itself from defective/incompetant pharmaceutical/medical products and services.
The rationale being that the Govt(FDA) which is lobbied to accept the recomendations of the medical industry, institutes rules and regulations that cannot be challenged in court.
In other words, the money of lobbyists is writting the legislation that demands obedience without the possibility of challenge.

I present the activities of GW Bush:


LINK

In a Shift, Bush Moves to Block Medical Suits

By ROBERT PEAR

Published: July 25, 2004


ASHINGTON, July 24 — The Bush administration has been going to court to block lawsuits by consumers who say they have been injured by prescription drugs and medical devices.

The administration contends that consumers cannot recover damages for such injuries if the products have been approved by the Food and Drug Administration. In court papers, the Justice Department acknowledges that this position reflects a "change in governmental policy," and it has persuaded some judges to accept its arguments, most recently scoring a victory in the federal appeals court in Philadelphia.

Allowing consumers to sue manufacturers would "undermine public health" and interfere with federal regulation of drugs and devices, by encouraging "lay judges and juries to second-guess" experts at the F.D.A., the government said in siding with the maker of a heart pump sued by the widow of a Pennsylvania man. Moreover, it said, if such lawsuits succeed, some good products may be removed from the market, depriving patients of beneficial treatments.

In 2002, at a legal symposium, the Bush administration outlined plans for "F.D.A. involvement in product liability lawsuits," and it has been methodically pursuing that strategy.

The administration's participation in the cases is consistent with President Bush's position on "tort reform."

Mr. Bush often attacks trial lawyers, saying their lawsuits impose a huge burden on the economy and drive up health costs. The Democrats' vice-presidential candidate, Senator John Edwards, a longtime plaintiffs' lawyer, says his proudest accomplishment in Washington was to help win Senate passage of a bill defining patients' rights, including the right to sue. (The bill never became law.)

Jay P. Lefkowitz, former director of Mr. Bush's Domestic Policy Council, said the F.D.A.'s litigation strategy embodied "good health policy and good tort reform."

But Representative Maurice D. Hinchey, Democrat of New York, said the administration had "taken the F.D.A. in a radical new direction, seeking to protect drug companies instead of the public." Mr. Hinchey recently persuaded the House to cut $500,000 from the budget of the agency's chief counsel as a penalty for its aggressive opposition to consumer lawsuits.

In the Pennsylvania ruling, issued Tuesday, the appeals court threw out a lawsuit filed by Barbara E. Horn, who said her husband had died because of defects in the design and manufacture of his heart pump. The Bush administration argued that federal law barred such claims because the device had been produced according to federal specifications. In its briefs, the administration conceded that "the views stated here differ from the views that the government advanced in 1997," in the United States Supreme Court.

At that time, the government said that F.D.A. approval of a medical device set the minimum standard, and that states could provide "additional protection to consumers." Now the Bush administration argues that the agency's approval of a device "sets a ceiling as well as a floor."

The administration said its position, holding that individual consumers have no right to sue, actually benefited consumers.

The threat of lawsuits, it said, "can harm the public health" by encouraging manufacturers to withdraw products from the market or to issue new warnings that overemphasize the risks and lead to "underutilization of beneficial treatments."

Allison M. Zieve, a lawyer at the Public Citizen Litigation Group who represented the plaintiff in the Pennsylvania case, said, "The government has done an about-face on this issue." If courts accept the administration's position, Ms. Zieve said, it would amount to a backdoor type of "tort reform" that would shield manufacturers from damage suits.

In the Pennsylvania case, the federal appeals court quoted extensively from the administration's brief and said the views of the F.D.A. were entitled to great deference because the agency was "uniquely qualified" to determine when federal law should take precedence over state law.

Bush administration officials said their goal was not to shield drug companies, but to vindicate the federal government's authority to regulate drug products.

Patients and their families said they felt betrayed.

sieg heil!!!

[Wino]

Stoner,
So much for GWB being a Compassionate Conservative or compassionate anything for that matter.

[GoneForNow]

If you accept the premise that all drugs and medical devices have unintended adverse effects (some unknown) you then have to strike a balance as how much potential harm is a society willing to find acceptable.

If you set the bar low you hinder the research to find new drugs, you create a disincentive to find more orphan drugs and you cause drug companies to place a higher price per pill or device to cover litigation expenses.

If you set the bar to high drug companies have no motivation to properly vet the drug or device which will result is less acceptable drugs hitting the market.

The key to setting the standard is the quality of the FDA review. If the FDA is tough and vigilant the bar can be set lower.

[Stoner]

And the court room is an inappropriate place to discuss the level of accepable deaths for profit?

[plschwartz]

I think there are several points here:
1. Can we be sure that the drug makers are reporting all the side effects they found? There is a small storm brewing because not all clinical trials need be reported to the FDA, as those which have not shown any benefit for the drug. I do not know if in those trials any side effects noted are thrown out.

2. Isit fair to sue for a side effect that had not shown up in any clinical trial.
Here I believe is the drug effect version of unlimited liability.

3. The question of risk to benefit ratio. If my childs life and nine others are saved and you child dies, do you have a right to sue the drug company? What they are doing then by having to charge more for the drug to cover legal costs is to pass along what used to be called "blood money" now called wrongful death money. This is basically I think what Bush is trying to disallow.
I think that what is needed is a "cold-blooded" table of blood money for shall we say a "no-fault" version of death according to some actuaral tables

[GoneForNow]

Originally Posted by Stoner

And the court room is an inappropriate place to discuss the level of accepable deaths for profit?

Yes, it is. Courts should not be deciding policy issues of a country. Courts have never performed this function and they aren't geared toward it. A court does not encourage an unhindered discussion of competing policy issues and/or discussion. The purpose of the court is to try the issue once the policy issues have been determined and accepted as the "norm". Allow me a question you can relate to on a visceral level: Do you want Mulder to make national policy in a courtroom or me?

PL........Has presented the current discussions taking place among policy makers and the movers and shakers. It's cold and some argue heartless but medical treatment will result in the deaths of some and save others.

[Ciberblade]

visceral, nice word

[Stoner]

Originally Posted by gbrumb

Yes, it is. Courts should not be deciding policy issues of a country. Courts have never performed this function and they aren't geared toward it. A court does not encourage an unhindered discussion of competing policy issues and/or discussion. The purpose of the court is to try the issue once the policy issues have been determined and accepted as the "norm". Allow me a question you can relate to on a visceral level: Do you want Mulder to make national policy in a courtroom or me?

PL........Has presented the current discussions taking place among policy makers and the movers and shakers. It's cold and some argue heartless but medical treatment will result in the deaths of some and save others.

Perhaps you missunderstood. I am puting this at the personal level.
Should an individual be denied access to justice in the court system
because of the profitability of a corporate venture, or in the case of medical malpractice, a personal level.

Realistically, if an issue is barred from consideration in the courts, there is little reason for legislators to overturn the laws that brought it about by lobbyist influences to begin with.

In effect, by restricting a citizen's ability to seek redress under the law, law is really 'rewritten' to the advantage of those that influence legislators the most--corporate America.

Recall or election of representatives become the only avenue for balancing the concerns that affect citizens and corporations, and currently both parties seem to be under the influence more of special interests than their electors.

If the courts are closed, why not be honest and just tear up the Constitution?

Do you want Mulder to make national policy in a courtroom or me?

Neither.
Perhaps if the Justice Department had viewed Bushes claim so that he couldn't order torture, Washington Post ..... these people wouldn't be having any legal troubles?

ABC

Setting national policy does indeed seem influenced by the legal system.
In this case, Bush dodged the bullet.
Tear up the Constitution and there's no one in authority to rectify the wrongs.
Looks, to me, like Bush has got a start at tearing up the Courts.

[GoneForNow]

Originally Posted by Stoner

Realistically, if an issue is barred from consideration in the courts, there is little reason for legislators to overturn the laws that brought it about by lobbyist influences to begin with.
In effect, by restricting a citizen's ability to seek redress under the law, law is really 'rewritten' to the advantage of those that influence legislators the most--corporate America.

Really? Then how do you explain workers compensation laws? Corporate America would love to do away with those laws yet they remain. Further, no one said that there wasn't redress to the courts, ever. If it can be demonstrated that the drug company failed to adequately test or rigged it's trials then the statutory protection wouldn't be available. Additionally, the Constitution does not guarantee you access to a court to redress your grievances, a common misconception.

Originally Posted by Stoner

Looks, to me, like Bush has got a start at tearing up the Courts.

If true then Bush wouldn't have lost the Gitmo case.

Originally Posted by Stoner

Perhaps you missunderstood. I am puting this at the personal level.
Should an individual be denied access to justice in the court system
because of the profitability of a corporate venture, or in the case of medical malpractice, a personal level.

Yes. Re-read PL's post. If the decision makers determine that more will benefit then will suffer.

[Stoner]

[gbrumb]Really? Then how do you explain workers compensation laws? Corporate America would love to do away with those laws yet they remain.

What's to explain? Perhaps that is next? or soon? or eventually? The fact that it is still with us is not grounds that it couldn't be eliminated.

Further, no one said that there wasn't redress to the courts, ever.

Ever may be a long time in the English language, but realistically, after the injured party dies, the awards often seem to disappear.

If it can be demonstrated that the drug company failed to adequately test or rigged it's trials then the statutory protection wouldn't be available.

Big if. Large awards have been handed out in the past for unexpected drug reactions. Sometimes intentionally poor data gathering to protect an FDA trial, sometimes just negligence in the testing program. The big awards go to 'classes' where there are obviously problems with one or both of the two examples suggested--negligence and fraud.
American Home Products had a problem with two of it's recent drugs that conflicted when combined for an effect not tested for. The Fen Phen problem. Both drugs satisfied the FDA. Neither was originally tested in combination for weight loss. Probably not fraud in the FDA trials,IMO.
The problem seemed to be Doctors, using the advice of marketing at AHP, wrote prescriptions for the combination.
Obvious negligence. Marketing made a corporate decision without testing.
So, enter Bush with the decision that Drug companies cannot be held responsible if the product passes the FDA trials. Now consider the fastracking FDA often does and negligence becomes an even larger factor the consumer has to deal with.

But let's go another direction with the FDA. I am familiar with this because I was affected.
Trials of the allergy treatment-EPD(enzyme potentatiated desensitization) were underway when I entered the experimental program
Note: This English therapy has been in use in England and Europe since the late 60's with no deaths and the only side affect being a 1 in 1000 chance of a short term migraine, and only on the first treatment. The effectiveness had been shown to be between 82 to 90 % .

Towards the end of the 5 year test, it was obvious the treatment was successful. But it was not allowed to go mainstream. The product was classified as a controlled substance and could not be imported. The port authority had orders for seizure and the penalty for receiving and distributing the same as cocaine trafficking. FDA's main issue was that the test didn't include a response for anaphylactic shock. Naturally, there could be no procedure for a situation that didn't create a response, an unknown response by an unknown reaction. The allergy material became illegal to posses.
Now....you're wondering why the long winded noise.....well....this treatment stopped all need for a patient to use antihistamines, about the biggest money maker for the drug industry, that is also among the largest contributors to, and lobbyists of Congress.
I can't prove anything , but the relationships and large amounts of money/profits involved do make at least me believe The FDA was motivated by other than the welfare of the public
I should also note that the worthless Liberal Congressional Rep from my district (Tony Hall) told me to go sue the government as a solution to my problems
Money talks, more money influences more legislators till the citizen is viewed only as a cash cow. The greatest good for the most number of citizens become a tool to protect profits.

GW Bush.....Patriot Act.....Lies to rationalize war.....prohibiting legal redress...no, he isn't doing all this in 'one giant step' but he does seem to be walking a path leading away from a democratic society.

Additionally, the Constitution does not guarantee you access to a court to redress your grievances, a common misconception.

True.............perhaps a dissenter of the drug and medical situation could be classified a 'terrorist' under the Patriot Act. After all, what patriotic American would ever complain about the harm in a little profit........._

If true then Bush wouldn't have lost the Gitmo case.

..........as Bushes power base becomes stronger, the day could come when situations like Gitmo aren't brought to light. Even now the International Red Cross claims there are secret US prison sites with potential problems:
http://www.cbsnews.com/stories/2004/...in614905.shtml

Yes. Re-read PL's post. If the decision makers determine that more will benefit then will suffer.

First... where do you stop. Unsafe cars? Unsafe food? What?
Second...who really is deciding?
Third... you make a good arguement for socializing the pharmaceutical industry, eh ( I don't think you want that and neither do I, but I couldn't help throwing in this zinger )


'what's the harm in a little profit '

[plschwartz]

American Home Products had a problem with two of it's recent drugs that conflicted when combined for an effect not tested for. The Fen Phen problem. Both drugs satisfied the FDA. Neither was originally tested in combination for weight loss. Probably not fraud in the FDA trials,IMO.

Stoner:
Sorry. AHP can suggest what they please. It is the individual doctor who is at fault for failing to check for drug interactions including those where the interactions are not known.
I am not a defender of drug companies, having worked in hospital I have seen detail-persons working up close. I have been involved in clinical trials and we also have a good friend who is a manager for drug development.
The problem like most is complex and demonizing the drug companies is just an easy way out.
The problem needs to be looked at systemically. Players include the drug Cos, the doctors and AMA the FDA medical journals who don't publish negative studies, trial lawyers the stock market and congress.
Of course the question is if Mr. Bush is capible of the kind of coordinated thinking

[Stoner]

pl,

I thought AHP was a good example of interactions without proper testing.
Without a warning to avoid the combinations, the Doctor's prescribing the pair had no reference to their combined dangers.
The negligence still goes back to the manufacturer not testing/specifying the hazards of the combination.

Apparently the FDA allowed AHP to slide on testing.

[~Candy~]

Since we are so far off topic anyway

I found this some time back and it is quite interesting (not drugs, but.......)

http://www.mercola.com/2004/jul/24/sweet_misery.htm

[bassetman]

Thanks Candy, interesting!

[~Candy~]

That's right you do diet coke in the morning too