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PostPosted: Thu Nov 03, 2005 4:08 pm 
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I never hide my loathing for those who see opportunity whenever "that other guy" or "those corporate fatcats" happen to get rewarded for their hard work. Wealth redistribution comes in many forms, but thievery is thievery. You want money? In my world, you earn it. You want a risk free life? Sorry - you were born in the wrong world.

All we ask is for people to be reasonable, and good to each other. There's no law against having a conscience and doing the right thing. Ethical business is good business. Being able to advertise yourself as such is a tremendous market advatage the way I see it. Whatever relatively rule free system rewards the good guys and leaves the bad guys behind is fine by me.

With avian flu knocking on our door, this is more than barroom debating about theoretical topics. The year 1918 saw the worst epidemic in world history - ever. It was a bird influenza that started in Kansas, spread amongst troops training for World War I, and killed millions around the world. Unlike other influenza strains, this didn't target the young and the elderly through a long course that ended with pneumonia. The virus itself caused the healthiest and strongest to react so violently against it that the immune system attacked the lung tissue. Within 24 hours, perfectly healthy young men would turn so dark from cyanosis that it was said you couldn't tell what race they were.

The only thing more shocking than the disease itself was the outright stupidity in the way it was handled. The United States was focused on a war that was consuming the world, and the nation needed to stay on task. The disease was minimized. Parades were held in cities like Philadelphia in spite of warnings by health experts. Within days, bodies accumulated in the city so rapidly that there was no reasonable means to dispose of them. This made New Orleans look like a party.

The disease spread so rapidly and affected the healthiest young men and women so selectively that it basically brought the German Army down to its knees. No other single event led to their surrender than did this virus that started in a Kansas chicken farm, mutated to a strain that could jump human to human, and spread around the world with ever increasing virulence.

It's only a matter of time before it happens again. The question is, how will we be able rapidly to respond with vaccines when we know they aren't risk free? With every treatment, there is a risk of disease and death. There is no excaping it. And the profit margins on a rapid vaccine development are slim to none even with no liability risk on the table. How can we as a nation respond with this nonsense looming in the background?

Slowly but surely, I see the nation waking up to the insanity of destroying one of our national assets. This victory today warms my heart. I hope it is one of many.

And may medicine evolve on with better and better treatments, better care, and better informed consent. And when perfect isn't possible, "good enough" should prevail. We need a healthy drug industry today capable of responding better and faster than anything we know right now. Maybe one day..

Quote:
Merck Scores Major Victory
In the Second Vioxx Trial


By HEATHER WON TESORIERO, BARBARA MARTINEZ and PAUL DAVIES
Staff Reporters of THE WALL STREET JOURNAL

November 3, 2005 11:01 a.m.


ATLANTIC CITY, N.J. -- Merck & Co. emerged entirely unscathed from the second high-stakes trial over its Vioxx painkiller, marking a critical comeback from a big loss in the first trial and giving the drug giant some momentum as it faces a wave of lawsuits related to its former blockbuster.

A state court jury concluded that Merck fairly represented the safety risks of its Vioxx painkiller, and further found that the drug played no role in the heart attack of the 60-year-old plaintiff. In addition, it determined that Merck didn't commit consumer fraud, meaning that it fairly marketed the drug to doctors and patients.

The jury of three men and six women deliberated for a little more than a full day before delivering its sweeping exoneration of Merck. Frederick "Mike" Humeston had alleged that Merck had failed to warn the public about its safety concerns over Vioxx, which he claimed had caused his heart attack after he took the drug intermittently for two months.

The jury, which heard seven weeks of testimony, had to consider two charges: failure to warn and consumer fraud. In deciding against Mr. Humeston on the first question, it concluded that Merck either did not know that Vioxx carried cardiovascular risks at the time that Mr. Humeston was prescribed it in 2001, or that the company adequately warned physicians about those risks. It further determined that Vioxx was not a substantial factor in causing the heart attack.

In considering the claim of consumer fraud, the jury examined whether the company had misrepresented Vioxx's risks or otherwise used "unconscionable practices" in marketing the drug to physicians. It decided Merck had not done so.

"We're very pleased with the jury's verdict," said Jim Fitzpatrick, a spokesman for Merck.

"This confirms our strategy" to fight each case individually based on the science. "I think the science is very clear that there is no short-term risk."

Merck pulled Vioxx from the market in September 2004 after a long-term study showed the drug doubled risk of heart attack or stroke if taken for 18 months or longer. At its peak, Vioxx brought Merck about $2.5 billion in annual revenues.

Inside the Case

A cornerstone of Merck's defense has been that low-dose, short-term use of Vioxx wasn't found to cause heart attacks. Mr. Humeston said he took the painkiller intermittently for only two months. Unlike the central figure in the Texas trial, who died, Mr. Humeston survived and is back at work.

Mr. Humeston's lawyers and expert witnesses said the clinical studies gave warning signs about its risk and that the company failed to adequately investigate them before introducing Vioxx in 1999.

The Food and Drug Administration approved Vioxx as "safe and effective" for treating different types of pain four separate times over the years, the last time a month before Merck pulled it off the market, Merck has said.

Agreeing with Mr. Humeston's lawyers that the best evidence in the case was Mr. Humeston himself, Merck's defense tean insisted his physical condition -- he had elevated blood pressure, was overweight and was under stress from a dispute with his U.S. Postal Service bosses -- triggered the Sept. 18, 2001 heart attack, not Vioxx.

Mr. Humeston had been given a 30-pill Vioxx prescription in May 2001 but didn't use it all because he said it wasn't working for him. But he got a second prescription two months later. Mr. Humeston and his wife, who also testified, remembered that he had taken the last pills in the bottle the night he was stricken, but she couldn't remember when his last dose was when she was asked at the hospital later.

Next Steps

The judge overseeing thousands of federal lawsuits said that an effort by plaintiff's lawyers to keep their cases in state courts was "counterproductive" to his desire to eventually settle all claims. "There's a movement afoot to work outside" multidistrict litigation, U.S. District Judge Eldon Fallon told lawyers at a status conference. "I think that's counterproductive."

The first federal Vioxx trial opens Nov. 28 in Houston.

Plaintiffs' lawyers Mark Lanier of Houston and Perry Weitz of New York say they have assembled a legal "dream team" of 10 law firms and 350 lawyers to push all future Vioxx lawsuits into state courts. Federal courts are generally considered more defense friendly. Plaintiffs allege the company knew Vioxx was dangerous years before withdrawing the drug but downplayed those concerns to push sales.

After the Nov. 28 Vioxx trials, the next federal Vioxx trials will be in February, March and April next year.

--Darren McDermott contributed to this article


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PostPosted: Thu Nov 03, 2005 4:46 pm 
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Off topic: Elected Judges:
http://www.brennancenter.org/presscente ... _0809.html

In the words of the vary judge who decided this case are in bold below:

Quote:
He was refreshingly candid in his discussion of the plaintiffs' allegation that the amendments were the result of business community pressure, explicitly noting "the close temporal relationship between the business community's expression of outrage and the subsequent changes" to the rules of court.
Even though Judge Fallon held that the amendments were substantively proper, he wrote that this did not render the allegations of political pressure inconsequential. Rather, he declared that the plaintiffs "may well [have raised] an issue in need of closer examination and debate, but the forum for addressing such questions is more properly a political, not a judicial, one."

Moreover, in a stunning closing remark that might well be perceived as passing from mere candor into actual cynicism, Judge Fallon declared: "Furthermore, in Louisiana, where state judges are elected, one cannot claim complete surprise when political pressure somehow manifests itself within the judiciary...


So if corporation are individual entities in the eyes of the law and corporations are run by individuals who vote - how can we imagine that elected judges are immune to the possible campaign consequences of their decisions in corporate cases?

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PostPosted: Thu Nov 03, 2005 5:35 pm 
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Bill Glasheen wrote:
Ethical business is good business. Being able to advertise yourself as such is a tremendous market advatage the way I see it.


I wish I could agree, but there's reams of examples of the opposite. That inethical behavior is wildly profitable. That's not to say that it's not a marketting advantage at all, just that it's obviously not enough to encourage chemical companies not to dump toxins everywhere, not enoughto encourage cigarette companies not to advertise to kids. The list goes on and on.

And while I see the connection you're trying to make between vaccines and this Vioxx thing, it looks to me like it's more of an emotional appeal. It seems almost to imply that unless we let biomedical companies do exactly as they please, we're all going to die of a dread plague.

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Last edited by Valkenar on Thu Nov 03, 2005 10:05 pm, edited 1 time in total.

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PostPosted: Thu Nov 03, 2005 6:39 pm 
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Despite the protestations of many, vaccine production has really never been hampered by the threat of product liability litigation.

And while all medical treatement has risks, we should support efforts of those companies who are up front about the potential dangers of their products and act to fully inform every one - providers and patients alike - of the risks and benefits of treatments. And by the same token, we ought to severely punish those companies and providers who seek to hide, confuse, obscure and lie about such things.

Cheers,
Gene


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PostPosted: Thu Nov 03, 2005 10:16 pm 
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Gene wrote:
Despite the protestations of many, vaccine production has really never been hampered by the threat of product liability litigation.

Oh really?

Perhaps you're not aware of [url=http://www.cdc.gov/nip/vacsafe/concerns/gbs/default.htm]Guillain-Barre Syndrome (GBS) and
Influenza Vaccine[/url]. After the swine flu scare of the 1970s and the mass vaccination encouraged by the Ford administration, there was a rash of these infections. The association is loose, but no association whatsoever between OBs and cerebral palsy babies still provided a fertile playground for the ambulance chasers, ruining the careers of many OBs. In today's environment, any company that produced such a vaccine would be buried in the rush for cash.

Perhaps you haven't been aware of the work being done by parents with autistic kids. They've been trying to establish a link between the MMR vaccine and autism. So far no go but... They can just smell the money.

These things can't be predicted, Gene. And a private sector company isn't stupid. Vaccines are a low profit commodity - particularly one required to treat millions on short order. A CEO would be abdicating his fiduciary responsibility to the shareholders by stepping into something with such risk for financial loss. That's why nobody's making any of these vaccines in the U.S. now, and why we have such shortages. I tried to get a flu shot just today and they turned me away. And I'm a member of a health care practitioner family.

Do you think anyone is sueing the FDA over this Vioxx mess? Heeelllll no. They get out of this mess scott free because of legislated legal immunity. Why shouldn't the drug companies deserve the same if they are such a critical part of our public health system?

Take a good look at Bush's new influenza program. Whether you like it or not, change is coming.

- Bill


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PostPosted: Thu Nov 03, 2005 10:38 pm 
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Dana wrote:
So if corporation are individual entities in the eyes of the law and corporations are run by individuals who vote - how can we imagine that elected judges are immune to the possible campaign consequences of their decisions in corporate cases?

Good question, Dana. And believe it or not, math has an answer.
Quote:
In 1906, Italian economist Vilfredo Pareto created a mathematical formula to describe the unequal distribution of wealth in his country, observing that twenty percent of the people owned eighty percent of the wealth.

I see this in my work all the time, Dana. The statistical distribution can be found in charges for a medical procedure, the amount of time someone stays in the hospital, the proportion of people who use up health insurance premium reserves, etc.

No matter where you are in the world, no matter how you start, at the end of the day 20% of the people will have 80% of the money. In a more detailed fashion we see this:

The richest 1% has a quarter of the wealth
The richest 2% has a third of the wealth
The richest 5% has half the wealth
The richest 20% has 80% of the wealth

So while this richer 20% has all the buying power, the poorer 80% has voting power over that 20% with the money. They have their own brand of tyranny that they can exercise in a purely democratic system with no protection afforded to minorities and no constitutional rights.

It is what it is.

And it is why you'll hear expressions such as "redistribution of wealth" amongst those who understand the principle, and don't care for super liberal, socialist, or communist systems.

Some of our founders such as Thomas Jefferson understood these laws of nature and tendencies of mankind. It is why we have the bill of rights and constitution that we have today.

- Bill


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PostPosted: Thu Nov 03, 2005 11:51 pm 
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Sovereign Immunity probably has a lot to do with the no one taking on the FDA. But I'd like to see the FDA do a better job.

The threat of litigation for vaccine manufacturers is profoundly mitigated by the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program. Not quite sure why it's an issue today. Economics, like Bill said. But since the national and global market for vaccines is far dwarfed by the national and global market for pharmaceuticals, it's a no brainer where companies are devoting their attention.

Somewhat unfortunate you couldn't get a shot, Bill. CDC says as of Oct 24 all persons are eligible for a dose. Maybe your particular doctor, clinic or pharmacy didn't have enough to go around. Spot shortages have been reported as manufactureres release their stock in waves, but all indications are there will be enough doses for this season. Flumist not an option?

Gene


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PostPosted: Fri Nov 04, 2005 1:18 am 
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My family doctor office has flu shots but is not too interested in supplying them... their price is about double of most places - around $60. We will shop around for a clinic.

Bill: I believe Westbury Pharmacy has them for $30.

Rich

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 Post subject: Maybe a case study....
PostPosted: Fri Nov 04, 2005 2:06 am 
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Rich, as a free-market capitalist, why do you think your family doctor is charging about double for flu shots than other places? Maybe the high cost of running a medical office? How 'bout supply and demand? I'm not trying to damn him (or her), but as a consumer of health care and a free-market true believer maybe you can make an observation. There are those who think healthc are shoudl not be governed by the free market...and I'd bet many of those people aren't super liberal, socialist, or communist and want to see the redistribution of wealth.

Gene


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PostPosted: Fri Nov 04, 2005 4:16 am 
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I do not really know but perhaps it is just more trouble than it is worth. Since the flu shot is available at local clinics and supermarkets and pharmacies they know that there is not really a supply problem. I will wait a couple more weeks for the demand to drop if for no other reason than to avoid a long line.

Rich

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PostPosted: Fri Nov 04, 2005 6:42 am 
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Gene

For the life of me, I don't know why my doctor's office is rationing, and yet my employer will provide the shots for free. It's very strange when you think about it. Only problem is that I will be traveling when the employer brings the shots to the office.

As for waiting, Rich, that's always a dicey proposition. If it's a light flu season, there will be extra. If there is a sudden outbreak, they will disappear fast, and that will be the time when you really wish you had gotten one. You are always taking your chances by waiting - particularly since the supply remains low this year. (One of the two big manufacturers still has reduced capacity this year.)

- Bill


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PostPosted: Fri Nov 04, 2005 6:47 am 
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It's worth mentioning that if we have an outbreak such as what happened in 1918, we will be SOL by today's technology. We just won't be able to respond quickly enough. One of the things Bush is seeking with his $7 billion proposal is for researchers completely to revamp the way we make flu vaccines. Chicken eggs likely will be gone, and we probably will be using tissue cultures.

But all that will take time to develop. We'll have to keep our fingers crossed that H5N1 or some yet unknown strain doesn't mutate and make the species jump before we have our collective acts together.

- Bill


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PostPosted: Fri Nov 04, 2005 8:02 pm 
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Gene, lawyers are working to target vaccine manufacturers despite those compensation programs. I'll try to find the citation. I think I read it in JAMA. Sutton's law....

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