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Trial Lawyers Now Take Aim at Drug Makers
The New York Times ^ | May 18, 2003 | ALEX BERENSON

Posted on 05/17/2003 2:20:05 PM PDT by sarcasm

Enriched and emboldened after successful fights against asbestos and tobacco companies, some of the nation's top plaintiffs' lawyers have trained their sights on drug makers, claiming that many giant pharmaceutical companies have hidden the dangers of medicines the lawyers say have harmed thousands of people.

In some cases the drugs at issue have already been pulled off the market, like Rezulin, a diabetes treatment from Pfizer that the Food and Drug Administration has linked to liver damage and is the target of almost 9,000 suits. Other suits name some of the industry's current best sellers, including Paxil, an antidepressant that plaintiffs contend is addictive — a claim denied by the drug's maker, GlaxoSmithKline.

In some instances, teams of plaintiffs' lawyers are spending several million dollars preparing cases for trial, in the hopes of winning billions of dollars in settlements and jury verdicts from the drug companies, which have some of the deepest pockets among American corporations.

The lawyers pursuing the suits say that the Food and Drug Administration has systemically failed to protect patients from dangerous drugs, and that the companies have tried to hide side effects. But the agency says medicines are safer now than they have ever been.

Within the industry, meanwhile, some experts on drug development say that juries may be ill-equipped to make the complicated cost-benefit analysis that the F.D.A. performs when it decides to approve new drugs. And companies have begun to consider the threat of lawsuits when deciding which new medicines to pursue, said Kenneth I. Kaitin, the director of Tufts Center for the Study of Drug Development, a nonprofit group that is supported by the industry. Companies, for example, have mostly stopped developing contraceptives, which are very vulnerable to lawsuits, Mr. Kaitin said.

Drug companies have always faced isolated claims about side effects from their medicines. But the new lawsuits are much larger, covering more drugs and many more plaintiffs. In addition to the 8,700 people who have sued Pfizer, the world's largest drug company, over Rezulin, an additional 32,000 people have said that they may sue, giving notice to avoid missing the opportunity to eventually file such claims.

Wyeth, another big drug company, has already set aside $14 billion since 1997 for claims by people who say they were injured by its diet drugs, and the company has been informed by an additional 90,000 people that they may sue. Johnson & Johnson and Bayer have also been been named in thousands of suits. Drugs from Bristol-Myers Squibb, Eli Lilly and Merck have also been named in lawsuits. A spokesman for the Pharmaceutical Research and Manufacturers of America, the industry's trade group, declined to comment on the wave of lawsuits.

With hundreds of thousands of people claiming that they have been injured by dangerous medicines and deserve compensation, the drug makers say that they are now spending several billion dollars each year to defend themselves from lawsuits and settle claims.

The new wave of lawsuits has come at a difficult time for the companies, which face heavy pressure over drug prices and accusations that they abuse patents to keep less-expensive generic competitors off the market.

Plaintiffs' lawyers say that the suits have increased because drug makers have introduced dangerous drugs and hidden their risks. In some cases, documents obtained from the companies themselves during pretrial investigations appear to back that claim. A note from an official at Bayer, introduced this spring in a Texas lawsuit over the company's cholesterol treatment, Baycol, was offered as evidence that Bayer deliberately avoided studying potential links between Baycol and a rare muscle disorder. "If the F.D.A. asks for bad news, we have to give, but if we don't have it, then we can't give it to them," the note said.

Bayer stopped selling Baycol in 2001 after more than 30 deaths from the disorder were linked to the drug. The company has said the drug was marketed properly and is safe when properly used.

The industry's focus on producing drugs for chronic conditions like depression and diabetes has vastly increased the pool of potential plaintiffs, because medicines for those diseases are taken by millions of people for years on end. And because clinical trials for new drugs are conducted on only a few thousand subjects, the tests do not always discover rare but dangerous side effects that surface after a drug is approved, according to experts on drug development — even at the F.D.A.

"All drugs have side effects, and even the safest approved drugs have side effects," said Dr. Janet Woodcock, the director of the agency's Center for Drug Evaluation and Research. "It is very likely that the newer classes of drugs in general are safer than older drugs, but you have to recognize that many more people are taking medicines now than used to."

Medical trends aside, plaintiffs' lawyers acknowledge that much of the momentum behind the suits comes from the increasing aggressiveness and wealth of the trial bar. These days, the battle between drug companies and plaintiffs' lawyers is no longer one between corporate goliaths and individual advocates on a shoestring budget.

"We've got plenty of a war chest," said J. Michael Papantonio, a lawyer in Pensacola, Fla., who is a leader in drug litigation. "It's a different day out there. It's not like they're going to look across a table from us and say, `We're going to dry you up.' "

Plaintiffs' lawyers can now finance enormously complicated suits that require years of pretrial work and substantial scientific expertise, in the hope of a multibillion-dollar payoff. Scores of firms collaborate on a case, with some responsible for finding claimants, others for managing the millions of documents that companies turn over, others for the written legal arguments, and still others for presenting the case to a jury. Some 60 firms have banded together, for example, in the Baycol litigation.

And even when they do not form explicit partnerships, plaintiffs' lawyers are working much more closely together than they once did. At conferences around the nation with names like "Mass Torts Made Perfect" — that one was organized by Mr. Papantonio and the lawyer-celebrity Johnnie L. Cochran Jr. — and "The Knowledge to Conquer," lawyers trade information and legal strategies.

"The plaintiffs have learned how to communicate and share information," said Robert J. Gordon, of Weitz & Luxenberg in Manhattan, which is among the largest plaintiffs' law firms in the country, with about 400 employees, including 70 lawyers.

In addition, the plaintiffs' bar has refined a technique in drug lawsuits that it has used effectively against many asbestos companies. Lawyers file a few cases with very sick plaintiffs in states and counties considered favorable to plaintiffs, while building big "inventories" of less seriously ill patients, or so-called pill-taker cases, even people who have used the drug but are not sick.

If the lawyers can win large verdicts in the early cases, they then refuse to settle the claims of their other very sick clients unless the defendants also agree to pay the claims of people who are less sick. Under those circumstances, the companies face a difficult choice. If they go to trial in a case that includes a few seriously injured plaintiffs and hundreds more who are less affected, they risk losing hundreds of millions of dollars in a single case, frightening Wall Street and spurring more suits. But if they settle cases without a trial, they risk being perceived as an easy mark for lawyers.

Finally, the Internet and television advertising have made finding potential plaintiffs much easier, plaintiffs' lawyers say. If a drug is withdrawn from the market or given a "black box" warning by the F.D.A., indicating that it has significant dangers, "the plaintiffs' lawyers make sure that word gets out," said Charles S. Zimmerman, a Minneapolis lawyer involved in the Baycol litigation and other drug lawsuits. "We're looking to make sure that people know they have a claim, and they know they're represented if they choose to be."

Plaintiffs' lawyers say that their new aggressiveness has not led them to attack good drugs. Instead, their new resources and methods have simply made them better able to press claims in what they say are the many cases when companies introduce dangerous drugs and hide their risks — which they say the F.D.A. does not adequately monitor once drugs are approved.

The public risks have increased over the last decade, the lawyers said, as the industry tries to meet Wall Street's demands for steady growth in profits. Some doctors agree.

"Are there systemic problems with the drug companies?" said Dr. David Egilman, a clinical associate professor in public health at Brown University who often consults for plaintiffs' lawyers. "The answer to that in some cases is yes," he said. Companies often hide information about the dangers of their drugs, he said, or market them in ways that increase the odds they will be prescribed inappropriately.

But medical experts who act as industry consultants say such accusations are unfair. "I've never seen a situation where a drug company encouraged the manufacturing of a drug that was potentially unsafe," said Mr. Kaitin of Tufts. And yet, drug companies are pressing the F.D.A. to approve drugs more quickly, he said, and those fast approvals can increase the risk that a medicine's side effects are not fully known when it is approved.

Mr. Kaitin, and some other public health specialists, say that juries are willing to make large awards in drug cases in part because the public misunderstands the risks and benefits that prescription medicines are supposed to provide.

No medicine is completely safe for everyone, said Dr. Kin-Wei Chan, a Harvard epidemiologist who also practices at a clinic in Boston and has consulted for both plaintiffs and defendants.

Because tests are conducted on a few thousand patients, drug companies cannot immediately know every side effect of their medicines, Dr. Chan said, but the family of a person who has been injured or died after taking a new medicine may have a difficult time accepting that fact. "For a family it's not one in a thousand or one in a million, it's one in one," he said. "But from a public health perspective, and I'm coming from a public health perspective, this is something we have to live with. We all have to recognize that we have to live with some nonzero risk."


TOPICS: News/Current Events
KEYWORDS: bigpharma; triallawyers

1 posted on 05/17/2003 2:20:05 PM PDT by sarcasm
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To: sarcasm
Huzzah for the lawyers. Trouble is, the drug companies are the wrong target. They should be going after the unscrupulus creeps prescribing them.
2 posted on 05/17/2003 2:34:58 PM PDT by conway
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To: sarcasm
The Shyster Business is a gigantic lamprey, slowly sucking the blood and internal organs out of the living.

The American Legal Industry, is an unregulated, utterly corrupt, gigantic money machine that serves no purpose but its own greed. It ravages one industry after another without compunction.

US Pharmaceutical companies are the world leader in research, saving lives, and amazing technological breakthroughs. Our health is st risk from the shysters.

3 posted on 05/17/2003 2:39:02 PM PDT by friendly
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To: friendly
US Pharmaceutical companies, in cahoots with the FDA, are probably the world leaders in killing people too.
4 posted on 05/17/2003 2:41:31 PM PDT by bluefish
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To: friendly
Further, the pharmaceutical industry has never been shy about using the Legal industry and corrupt government agencies (FDA) to crush competition, hide facts from the public, inflate drug price and prevent us from making our own health care choices.
5 posted on 05/17/2003 2:43:51 PM PDT by bluefish
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To: conway
They should be going after the unscrupulus creeps prescribing them.

Your comment suggests that prescribing doctors are aware of various hazards with medications and ignore the risks, and do not believe that the benefit of whatever it is they prescribe is greater than the risk.

Is that what you mean?

6 posted on 05/17/2003 2:45:28 PM PDT by RJCogburn (Yes, I will call it bold talk for a......)
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To: bluefish
prevent us from making our own health care choices.

No, it is ultimately the government that prevents us.

7 posted on 05/17/2003 2:49:17 PM PDT by RJCogburn (Yes, I will call it bold talk for a......)
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To: sarcasm
The lawyers pursuing the suits say that the Food and Drug Administration has systemically failed to protect patients from dangerous drugs.

So why sue the pharmaceutical industry when they spend millions of $ and years to get FDA approval? Yeah I know, sovereign immunity.

And even when they do not form explicit partnerships, plaintiffs' lawyers are working much more closely together than they once did.

When corporations do this the ambulance chasers end up calling it "price fixing" or "restraint of trade" and fire up the lawsuits.

8 posted on 05/17/2003 2:51:26 PM PDT by roderick
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To: RJCogburn
The govt. and the pharmaceutical industry are in it together. Where do retiring FDA beureacrats end up with cushy, high paying jobs? Who feeds the campaign coffers of the corrupt government officials? The pharmaceutical industry has learned how to work the system in order to defeat competition. The government does the bidding of the evil pharm giants.
9 posted on 05/17/2003 2:52:07 PM PDT by bluefish
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To: conway
"They should be going after the unscrupulus creeps prescribing them."

Then they wouldn't be able to make as many billions. The problem is they could care less about the patients. Therefore, they start frivilous class action lawsuits, as against the drug companies (remember the phony breast implant thing a few years ago?) and tobacco companies....

So that the few people who have REAL clamins, REAL cases, are SO FAR LOST IN THE WORLD OF FRIVOLOUS LAWSUIT MAKE-BELIEVE THAT NO ONE, NO WHERE, KNOWS WHO'S GUILTY AND WHO'S GETTING THE SHAFT BY THE LAWYERS LIKE EVERYONE ELSE (pseudoephedrine suddenly comes to mind as an example of EVERYONE getting screwed by the trial lawyers)

Two words: torte reform.

10 posted on 05/17/2003 2:53:00 PM PDT by cake_crumb (UN Resolutions=Very Expensive, Very SCRATCHY Toilet Paper)
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To: cake_crumb
I agree with much of what you said (I disagree with the need to shout though). Tort reform is needed, as is the abolition of the FDA. The FDA does not work in our interests.
11 posted on 05/17/2003 2:55:30 PM PDT by bluefish
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To: cake_crumb
CLAMINS???? Uh...'claims'.

Anyhow, the rest stands. Trial lawyers are in it for hundreds of millions apiece in personal profit. They could care less about people. They HAVE been known to manufacture victims. (breast implants)

12 posted on 05/17/2003 2:58:21 PM PDT by cake_crumb (UN Resolutions=Very Expensive, Very SCRATCHY Toilet Paper)
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To: bluefish
"Who feeds the campaign coffers of the corrupt government officials?"

Ask the Dems. They're the ones who made the industry. Why's a trial lawyer running for president?

13 posted on 05/17/2003 3:00:43 PM PDT by cake_crumb (UN Resolutions=Very Expensive, Very SCRATCHY Toilet Paper)
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To: roderick
And even when they do not form explicit partnerships, plaintiffs' lawyers are working much more closely together than they once did. When corporations do this the ambulance chasers end up calling it "price fixing" or "restraint of trade" and fire up the lawsuits.

An excellent point in the midst of a sea of ignorant posts.

14 posted on 05/17/2003 3:01:13 PM PDT by friendly
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To: bluefish
The govt. and the pharmaceutical industry are in it together

No argument, just as the companies in any regulated industry are in it with the regulators.

So, how do we fix it? Not by more regulations which as you recognize will not work when regulators and regulatees are in each other's pockets.

Get the government out of the game. Then the symbiotic relationship will end. There really is no other way, is there?

15 posted on 05/17/2003 3:02:11 PM PDT by RJCogburn (Yes, I will call it bold talk for a......)
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To: cake_crumb
perfect insights on your part.
16 posted on 05/17/2003 3:03:19 PM PDT by friendly
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To: sarcasm
Tort reform now Mr. Bush.
17 posted on 05/17/2003 3:03:28 PM PDT by Sparta
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To: cake_crumb
Two words: torte reform.

Right...a major overhaul. I sympathize with the docs' malpractice problems but they have too narrow a focus. The problem is widespread thoughout our society and only widespread reform will have any hope of really making things better.

18 posted on 05/17/2003 3:05:04 PM PDT by RJCogburn (Yes, I will call it bold talk for a......)
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To: Sparta
You mean it's not

reform?

19 posted on 05/17/2003 3:09:20 PM PDT by sarcasm (Tancredo 2004)
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To: RJCogburn
Get the government out of the game. Then the symbiotic relationship will end. There really is no other way, is there?

Yes, you are correct. There is no other way.

20 posted on 05/17/2003 3:34:01 PM PDT by bluefish
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To: RJCogburn
I'm specifically targeting psychotrophic drugs where the side effecrt are clearly stated. Side effects that lead to suicidal thoughts for example are given to patients that are having suicidal thoughts.

Behind every mass slaughter and mother killing her children, you will find these drugs at work.

21 posted on 05/17/2003 3:40:01 PM PDT by conway
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To: cake_crumb; RJCogburn
Yes, Dems and Trial Lawyers are two rotten peas in a pod. This story is interesting though. The trial lawyers going after the phar. giants will by default, bring the FDA's relationship with the pharm giants to light. It already has as evidenced by a few quotes in the article. If this gets traction, the "symbiotic" relationship that RJ_Cogburn refers to will be breached as the two entities (Pharm Industry & FDA) begin to turn on each other for self-preservation. The Pharm industry, by virtue of the Trial Lawyer attacks, will have to join the anti-government folks for survival.

Alternatively, and more ominously, there is the possibility that the govt. and pharm giants get more in bed with each other with the Pharm industry agreeing to a settlement like the tobacco industry did. They pay big bucks to the govt. in the same type of protection racket that the tobacco industry now does. The govt. gets addicted to the money and the people are screwed even further. The govt. has greater control with no incentive to end the problem of bad drugs. So far, the difference here is that the govt. isn't doing the suing, but it will enter the fray.

22 posted on 05/17/2003 3:47:00 PM PDT by bluefish
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To: friendly
US Pharmaceutical companies are the world leader in research, saving lives, and amazing technological breakthroughs.

And that's why trial lawyers will lose this one, maybe even beach themselves on the counter-suits that get filed. Big Phama lawyers are some of the best in the business.

If life-saving medicines fail to get to market due to fabricated tort distractions, the public at large will crucify tort lawyers.

Tobacco, while a scape-goat for alot, was somehow less defensible. The public hasn't stood by an industry so roundly implicated in contributing to poor public heath.

BigPharma may actually wind up healing more things in our American system than just our physical well-being.

23 posted on 05/17/2003 3:59:53 PM PDT by Agamemnon
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To: conway
Behind every mass slaughter and mother killing her children, you will find these drugs at work.

Correlation does not equal causation. The fact that a mother is inclined to kill her kids may be why she is on the drugs, with the drugs failing to work. It doesn't necessarily follow from a purely logical standpoint that the drugs caused the mother to kill her kids. Problem with this is the old chicken / egg thing. Which came first? Craziness or the drugs? The drugs would not enter the picture if the mother wasn't already having problems. Failure of the drugs to work may be as reasonable an explanation as the the drugs causing somebody to do something when looked at this way.

For me, I look at things like cholesterol drugs that destroy your liver sitting on the pharmacy shelves while the pharm giants sue to prevent a natural substance upon which they are based from being imported (Red Rice Yeast Extract). The FDA pulling an Amino Acid (Tryptophan) from the market a week before Prozac is launched, using a contaminated batch from Japan years ago as an excuse (why isn't Tylenol still off the market?). The delays of life saving drugs from other countries in an effort to allow US companies to produce their own version. The overpriced US drugs relative to the rest of the world. On and on and on...

24 posted on 05/17/2003 4:00:33 PM PDT by bluefish
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To: Agamemnon
You are on the same track that I was in my first paragraph in post 22. My second paragraph is a fear though.

However, you state:

If life-saving medicines fail to get to market due to fabricated tort distractions, the public at large will crucify tort lawyers.

Why hasn't the public crucified the FDA? I can name a lot of drugs from smaller companies that would save lives that continue to be held up by FDA bureacracy and expense. The FDA is waiting for their chosen class of companies to come up with an alternative in my opinion. Some of these drugs are approved all over the world but here. The same thing exists with some foreign drugs. It isn't possible to argue higher standards here either because in many countries, the approval process is just as difficult due to the same political and economic considerations that pervade the process here. It is all a sham.

I hope you and I are both correct. I would love to see the Pharms, as a result of the suits, break free from the FDA and simultaneously damage the Lawsuit industry.

25 posted on 05/17/2003 4:08:11 PM PDT by bluefish
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To: bluefish
US Pharmaceutical companies, in cahoots with the FDA, are probably the world leaders in killing people too.

One this thread's obviously less-informed postings.

26 posted on 05/17/2003 4:13:16 PM PDT by Agamemnon
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To: sarcasm
Do you ever see a headline like, "X, takes aim at trial lawyers?"

No, too bad.

5.56mm

27 posted on 05/17/2003 4:14:26 PM PDT by M Kehoe
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To: conway
Behind every mass slaughter and mother killing her children, you will find these drugs at work.

Blame therapeutic drugs as much as you like, but I think you'll also find a fundamentally disturbed person lurking somewhere in there without having to look too far. Blaming the drugs is too easy a straw man.

28 posted on 05/17/2003 4:24:07 PM PDT by Agamemnon
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To: bluefish
Blue,

I have 21+ years in my career in the pharmaceutical industry. I started my career with 5 years in R&D (mid-sized pharma firm), followed by 5 years in Quality Control/ Quality Assurance (Big pharma), then I went to work for FDA as a review chemist for 2 years.

Due to prior industry relationships, I was invited to return to industry and joined a Big pharma firm to head a regulatory department for a Big pharma firm. I am now in business for myself in my own consulting firm for the past 7 years, advising Pharma clients (pharmaceuticals, device, biothechnology) with regard to their manufacturing operations, and regulatory position vis a vis FDA. Additionally, I also serve as VP of Regulatory Affairs and Quality Operations for of a "virtual," start up pharmaceutical development firm.

I shared that with you to tell you that your perspective of the regulatory review process at FDA vis a vis industry requires better insight. This process, imperfect as it may be in many ways, has resulted in the most efficacious, and safest therapeutic drug supply the world has ever known.

Does FDA have some pin-heads? Sure. Does industry? Sure. Do health food stores (I take supplements too BTW). Sure they do. Is there a big conspiracy between the FDA and industry to keep valuable medicine's off the market? NO.

FDA doesn't approve a drug per se. It approves what a firm can say about a drug which is intended for entry into interstate commerce. FDA, with the exception of Schedule 1 narcotics where DEA is also a regualtory agency, cannot and it does not insert itself between a doctor and a patient relationship (my father is a physician). If a doctor prescribes a medicine for a use it is not demonstrated safe and efficacious as indicated on the label, the legal liability shifts from the drug product maker to the physician. He does so at his own risk.

Many Far-Eastern sourced medicines are under clinical investigation. Establishing efficacy and safety, as with any drug product, is something which must be established in order to make legitimate therapeutic claims about their efficacy. From what I have seen of manufacturing operations and controls thereon at many far-Eastern manufacturing facilities (having audited quite a number of them) you should be thankful that alot of what is made over there in not yet approved for sale here -- even well-known drug substances.

Sure, there are some medicines approved for use in other countries. Thalidomide was available in Europe in the late 1950's when, it was not available for approved use in the US. Marketed as an expectant mother's little helper, it was responsible for the famous "Thalidomide Baby" deformities that resulted.

In 1938, in the US, the Sulfanilamide debacle saw a firm performing a "from the hip" formulation modification, substituting the safe propylene glycol with what was the less well-characterized diluent at the time, ethylene glycol. The cavalier formualtion substitution was responsible for blindness of the unfortunate patients.

Under Theodore Roosevelt, in 1906 the Food, Drug, and Cosmetic Acts were passed in order to control all the traveling "snake oil" salesmen, famous for making claims about products, some of which proved to be out right poisonous to unsuspecting users.

More recently, a firm manufacturing a generic version of Albuterol (Copley Pharmaceuticals) marketed bacterially contaminated allergy inhalents outside of approved established manufacturing practices. Several users were killed. The company has since folded and got bought out following a lengthy FDA investigation.

FDA is a part of the Public Health Service (established in 1798). As a pharmacutical professional whose experience covers all sized firms, in all stages of their development, foreign clients and domestic, and most technologies including some quite novel ones, I say unequivocably: The FDA has its legitimate public safety purpose.

29 posted on 05/17/2003 6:51:20 PM PDT by Agamemnon
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To: Agamemnon
Thanks for your intelligent posts, amidst a lot of disinformation and thread disruption lunacy.

Germany was once the world leader in pharma, with the world's largest and most advanced research firms. After 20 years of complete mismanagement by the government, there is not a single German company in the top 10 companies.

My point is I would not underestimate the destructive power of the lawyer industry. Things like trauma care, neurosurgery and many other high technology fields are being devastated by the mega-greed of the despicable shyster industry.

The US pharma industry is in serious danger from these powerful grasping charlatans.

30 posted on 05/17/2003 9:13:22 PM PDT by friendly
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To: Agamemnon
It was the first day of school and the teacher thought she'd get to
know the kids by asking them their names and what their fathers did for a living.

The first little girl said, "My name is Mary and my daddy is a
postman."

The next little boy said, "I'm Andy and my Dad is a mechanic."

It was then little Johnny's turn and he said, "My name is Johnny and
my father is a striptease dancer in a cabaret for gay men."

The teacher gasped and quickly moved on, but later, in the school yard, the teacher approaches Johnny privately and asks if it was really true that his Dad dances nude in a gay bar.

Little Johnny blushed and said,

"No, he's really a lawyer, but I was too embarrassed to say so."
31 posted on 05/17/2003 9:39:31 PM PDT by friendly
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To: Agamemnon
I appreciate your insights Agamemnon. However, they sound like PR talking points. I can't say that you have convinced me.

Some of us may see you as nothing more than part of the problem, rationalizing away your own contribution to the mess. Your bias, as "well informed" as you think it may be, is still bias. Your opinion cannot be the final word on the matter by virtue of your being on the inside, or even by virtue of your having been on both sides. You see, you actually represent the "symbiotic relationship" between the Pharms and the FDA that another poster spoke of. Your bias as an insider is clear and your defense of the industry, both FDA and Pharm, illustrates the other poster's point. My bias is only that of a consumer and nothing more.

Please understand that this is not intended as a personal attack. My comments on why the problem exists follow in a few paragraphs.

I find holding up Thalidomide as an example of a drug we were protected from somewhat humorous, since they gave it "restricted" approval a few years back. If it deforms babies, should it really be floating around through our system now, pregnant or not? Truly strange.

Pharmaceuticals destroyed my Fathers liver. I've taken ephedrine - the FDA's most hated Pharm competitor - for years without problems. I knew two people taking Phen Fen and pitied their absolute fear over the heart valve issue when it came out. I was comfortable with the hundreds of studies demonstrating the safety and effectiveness of Ephedrine as compared to the flops offered up by the Pharm industry.

I understand that the Pharm industry has some new beta-3 agonists waiting in the wings, developed as the result of insights as to why ephedrine works with diminishing side-effects - something they tried to hide. Sure enough, the FDA is heating up its campaign against ephedrine too. How convenient. Can't wait to see how many more times these wonderful products, with a shorter safety record, will cost me after they pull ephedrine. I also can't wait to find out that they will cause my intestines to detach themselves from my body or some such nonsense.

I can begin listing lifesaving drugs that the FDA refuses to approve here, despite decades long safety records. You hold up Thalidomide as an example of the FDA's wonderful work. I can respond by listing the multitude of drugs that the FDA approved that ended up killing and maiming people here (Thalidomide excepted). I can list Pharmaceutical companies doing important work that were bankrupted by the slow, cumbersome approval process, which does NOT add to the safety profile of drugs that are ultimately approved. I can list countless examples of nutritional substances that the FDA attacked while approving a direct pharmaceutical competitor with a more questionable safety record and greater side-effect profile.

All of this, combined with the obvious "friendly relationship" that the FDA has with large US drugmakers (your situation being a perfect example), rather than the adversarial one that should exist, leaves the claim that the FDA is here to protect us consumers somewhat dubious.

I don't like the FDA. I prefer to make my own decisons for myself. My freedom is restricted in a supposed effort to protect people. If truly "protecting" us from ourselves is all the FDA is really about, then why not go all out with the concept and apply the same standards to every industry, product, recreational activity and life-choice that we as supposedly FREE Americans make for ourselves? You may claim that it is more critical for Pharms because we are talking about our health. To which I would simply respond with statistics demonstrating just how well "protected" (as well as empty-pocketed) the FDA has left us.

The FDA's "officially approved" drugs kill us, bankrupt us and leave us in need of more drugs to counter the side effects of the original. Those approved drugs are manufactured and sold to us by the Pharms, at prices inflated due to bureacratic inefficiencies and callous, bureacratic indifference to their original purpose.

No, I do not believe there is a grand conspiracy. I believe that human nature (greed, pride, laziness, etc.) takes its course in large bureacracies and corporate environments as easily as it does with individuals. When a bureacracy gets too large and powerful, it is difficult for the increasingly more scarce "good" person to do anything about it. With regards to the FDA and the Pharms though, there are countless examples of obvious (albeit circumstantial) collusion and corruption.

The debate is the same as the one surrounding the purpose of government. When government becomes too large, it cannot perform its intended function. The FDA is too large and powerful. It does not protect us. It serves the large drugmakers as much or more than it serves us. Ultimately, like any bureacracy, it serves itself and nobody else. These people are not benevolant Gods who will bestow great blessing on us. I prefer to protect myself, thank-you very much. I may be "ill-informed," but I at least know where my motives lie when making choices for myself. Clinton was brilliant, but that doesn't mean he was good for us. Same with you, the FDA and many Pharm gian insiders.

I am not anti-pharmaceutical by any means. I have a few of my favorites which happen to do me a world of good. I don't like the giant FDA/Pharm symbiosis that corrupts the brilliant and good work of many well-meaning people in the industry. Please understand that I am attacking a system, which through the nature of large organizations, is bankrupt with regards to achieving its intended purpose. A purpose which I believe, from a philosophical standpoint, should end with providing education to consumers at the extreme end.

My rant is done. Again, I do not intend for you to take any of it personally, although that may be hard to do. Consider where I am coming from and ask yourself if my points, if only from a philosophical perspective (he should be free to take care of himself) makes any sense. Don't tell me which pharmaceuticals I have to take and I won't tell you which type of computer you HAVE to use. Fair?

32 posted on 05/17/2003 10:32:15 PM PDT by bluefish
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To: sarcasm
Trial lawyers will destroy this country. Billy Shakespeare was a visionary.
33 posted on 05/17/2003 10:36:13 PM PDT by ampat
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To: sarcasm
Grandma's monthly drug bill will go up another $1200.00 after this is done !
34 posted on 05/17/2003 10:36:38 PM PDT by america-rules (I'm one proud American right now !)
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To: bluefish
I'll let you take it up with your own conscience whether you meant to let your comments get personal, or not. I don't particularly care. This is a debating forum and readers can judge for themselves too. But if all you got out of my last posting was "PR talking points," then it is ill-informed self-statisfation derived from your continuing state of blissful ignorance which is most deserving of pity.

We have stated our cases in lengthy posts and any reader can decide what value, if any, to place on either of them simply on the basis of who has demonstrated themselves to be the more informed on this topic.

You are a consumer, currently of uncertain academic and/or professional achievement, or pedigree. You are of course welcome to share that information, and establish more of your authority on this topic. I happen to possess 4 undergraduate and graduate degrees in various natural sciences and business from well-known universities and medical colleges. My previous career path has already been noted.

Hopefully, when we learn of yours it will be something a little bit more beyond your emotion-laced diatribe about ephedrine, Phenfen and "Pharmaceuticals destroyed my Fathers liver" stuff. In concert with our physicians, we hopefully make our best therapeutic choices, and balance our desired quailty of life as measured against life what each of our physiques will allow. The FDA's approval of your father's medication didn't destroy your father's liver. A daily fifth of Jack Daniels might. I don't know your father's medical condition or inclinations, whether he used his medications properly, or believed "if some's good, more's better." Maybe he took self-medication with perscription medications too far. The possibilities are as endless as your father's experience is an isolated case.

Extensive clinical trials are done prior to medicines being approved for marketing to show statistically significant endpoints for which the drug products will be labelled and marketed. Toxicology studies reveal possible side-effects which might be anticipated. These are therapeutic predictors, and cannot be all encompassing. To guard this, "Post-marketing surveilllance" is required for approved products, as it is called. Such a requirement revealed problems with Phenfen in larger populations. Problems with ephedrine were seen in women of child-bearing age. FDA has rightly stepped in on both.

Smirk humorously about what you don't know about Thalidomide, if you like. There is a proper use and misuse of many things, drugs included. Last word on Thalidomide is this: drugs are therapeutic in dosage and context of patient populations. You must learn to differentiate or risk being perceived as unstudied. Approval as "mother's little helper" was thankfully not obtained here as it was rushed to market in Europe. It's use as a potential AIDS therapy on the other hand is promising. Note the obvious difference in patient populations.

If you think that there is something to your assertion that there is this "cozy" relationship FDA supposedly has with BigPharma, you'll have to explain what BigPharma had to do with the passage of the Hatch-Waxman Amendments of 1984 to the Food And Drug Act, which facilitated the development of the much-lower cost generic versions of approved drugs.

The mission of the Office of Generics at FDA is to bring as many generic versions of medicines coming off-patent, as they can legitimately approve, as demonstrated by the generic applicant's abilty to demonstrate "sameness," according to stringent quality and bioequivalence guidelines. This has contributed to a dramatic cost reduction in pharmaceutical therapeutic availabilities, and for health care overall.

Unless you are a clinician or medical professional of some accomplishment, demonstrating at least some rudimentary accomplishment as a bio-statistician, I wouldn't characterize yourself of being able to assess cogently any "studies" you want to point to to make your case. I can read summaries and interpretations of data about as well as you can. The difference is I can probably cut through the spin with a little more skill than you.

I'm sure you can list all sorts of therapies that aren't approved for sale here. Produce some credible evidence (not merely epidemiological and isolated examples) that the medicines work and are safe, and you can receive approval to market, maybe even a patent. Problem is, your marketeers don't want to make the necessary case that their stuff works (don't want to invest in credible R&D either), but want to sell it in the US making such unproven claims.

FDA won't let them, and the US drug and therapeutics supply will remain the better for it.

35 posted on 05/18/2003 1:55:36 PM PDT by Agamemnon
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To: Agamemnon
You are correct Agamemnon. I do not have a wall full of degrees in pharmacology as you do. Nor do I have the experience or vast store of knowledge that you do. I readily acknowledge that.

Nor do I have the arrogance or overly inflated ego that you seemed to have developed along with your expertise in a specific industry. Your need to state your credentials numerous times, and in great detail, suggests that a certain amount of uncertainty about some other aspect of your life must be present. What are you attempting to compensate for? Perhaps you haven't applied that knowledge for MY benefit. Perhaps you have actually used it to do some things that deep down inside you know harms me? So you trot out your credentials and I am supposed to automatically accept that as a result of your education and knowledge, everything you accomplish is benevolant? Sorry, but some of the most evil men in history were highly educated, so drop the smug superiority thing. It is not becoming and it doesn't make your case.

I still stand by my "ill-informed" statements, as you have told me nothing that any "highly educated" bureaucrat in any other industry would tell somebody who complains about that bureacrat's meddling in our lives. I read your post as more PR talking points.

What you fail to understand, and what your post failed to address, was my primary point which was illustrated by my last question: What RIGHT do you have to tell me what I can take and what I can't? What RIGHT do YOU have to decide for ME whatis appropriate and what is not. You can supply me with your "esteemed" opinion and I will gladly listen. I'm sure you have plenty to offer. When you take for yourself authority over my life however, I have to ask what your motive is.

You don't get it, do you? There are many things for which I am probably much more informed than you. As I stated in my last post however, I do not take that superior knowledge as a God-given right to direct your life with it.

My primary issue Agamemnon is personal freedom above all else. Yours appears to be convincing me that you and your FDA buddies have the right to control my life for personal profit because you sat in a classroom, wrote some papers and kissed some higher-level bureaucrat's ass. Well I won't bow down, despite your superior knowledge, because that knowledge is not neccessarily, by default, applied for my benefit or for the greater good. You can make your case, but as long as you insist that your education gives you the authority to direct MY life, you are nothing more than a highly educated dictatorial bureaucrat.

Morally, the FDA's authority to confiscate a drug, herb or vitamin is no more valid than a scummy trial lawyer's ability to confiscate money from a less "educated and experienced" defendant in a civil case.

36 posted on 05/18/2003 4:03:37 PM PDT by bluefish
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To: bluefish
I still stand by my "ill-informed" statements....

Not surprising that you'd continue to demonstrate the ignorance of your first ill-informed post.

What RIGHT do you have to tell me what I can take and what I can't? What RIGHT do YOU have to decide for ME whatis appropriate and what is not.

Unless its a Schedule 1 narcotic (e.g., Tetrahydrocannibol -- as found in Pot, cocaine, or opium, for instance), take anything you want. Inject yourself with gasoline, if you think it will make your hair grow. No one is stopping you, not even FDA. Your freedom to dose yourself up with anything is as easy as taking an overdose of sleeping pills. FDA won't stop you, unless you try to sell gasoline injections for the advertised purpose of growing hair.

You're clearly out of your league on this thread. You are clinically illiterate, and merely attempting to project your sad lack of personal accomplishment, and your intellectual inadequacies in a rambling, unintelligible rant, larded with pap, and psychobabble. Nice try, but no less pathetic.

Sorry, but some of the most evil men in history were highly educated....

And that is your defense for your stunted intellect? Really, Blue, the more you talk, the more you make my point.

Get a grip, take a deep breath, get some education, screw on your head before you blubber more nonsense, and come back when you have something to say that's more than just another temper tantrum.

There are many things for which I am probably much more informed than you.

Yes and you probably knit better than I do too, but that is irrelevant now, isn't it?

37 posted on 05/18/2003 6:51:30 PM PDT by Agamemnon
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To: Agamemnon
Heh heh.. You continue to make a larger and larger mockery of your own inflated sense of superiority based on your edjumacation.

Don't hurt your shoulder while patting yourslef on the back there for your lofty achievements professor. You also might want to back away from your microscopic inspection of the trees as well. You may discover that there is a whole forest around you! Some of us see it.

I don't need a Phd in Biology or Pharmacology to recognize good-old fashioned corruption. Your Phd has blinded you to it however. Your lack of common sense, decorum, humility and general decency is showing more and more.

You are just like Clinton trying to discuss the "meaning of is" in order to avoid the real debate. You chuckle to yourself at how clever and brilliant you are, failing to understand that the debate is not about all your wonderful "knowledge."

You are so busy discussing my "lack of intellect" that you have failed to point out where the intellect is lacking. I'm afraid you are the one in over your head, because your last post did not draw on your wealth of academic knowledge and industry achievements. It drew on nothing more than a snobbish, 8th grade sense of unfounded superiority and nothing more. I knew I could bring it out.

You have refused to address my primary point (other than tossing in a lie or two about the lack of power that the FDA has), because you can't. You say go ahead and inject gasoline to counter my claim that your corrupt FDA buddies interfere in our lives. The reality is that if I chose to do so, they would insure that the gasoline is not available, driving up the price. They would then lie to Congress to get laws passed against it. Your claim that the FDA has no power is a complete distortion of the facts and you know it.

I refused to engage in your attempt to compare drugs, cases and anecdotes because citing whipping out our manhood and comparing its length is not a game I am interested in. I am interested in the larger issue: Excessive Governmental Power and Personal Freedom. Your response: "You are a big dummy!" You obviously can't win THAT debate.

38 posted on 05/18/2003 7:32:29 PM PDT by bluefish
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To: Agamemnon
Oh yes, another thing.. Every one of the items you plucked from my prior post was taken out of context. For all your intellectual genious, you should know that is intellectually dishonest. You also plucked the minor points and ignored the major ones, while creating a beautifully written paragraph concerning my ignorance. of course you didn't bother to explain yourself. Opinions are like a##holes. Even super-scientists have them.

So tell me about the "advising" that you do for the Pharms. Does it go something like this:

"If you hide this data here, and bury these results there and fudge these numbers just a little bit, those idiots will never see the truth and we have the next blockbuster! If they start to uncover some of this, I will simply engage them in a discussion about the meaning of is. I know how those dolts work. I use to work there you know. Did I mention the 4 degrees I have that makes me smarter them?"

"Sigh.. yes Agamemnon, you mention your degrees every day. Now which numbers do I fudge again?"

Whew! That was all in good fun Agamemon. Laugh it off or get defensive and construct another masterfully written piece of prose discussing how uneducated I am (I might even steal it for a future response, because your posts ARE good!

39 posted on 05/18/2003 8:16:37 PM PDT by bluefish
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