My go at trying to wrest the scare phrase "big Pharma" away from the luddites.

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April 21, 2006

Vioxx Guilty -- But Maybe " Guilty " of Preventing Death, Too

By Elizabeth M. Whelan, Sc.D., M.P.H.



When consumers read about a South Texas jury finding Merck & Co. liable today for the death of a seventy-one-year-old man who had a fatal heart attack within a month of taking the painkiller Vioxx, they will likely conclude: "this is good -- a big bad company is being held responsible for their evil medicine causing harm." The company was ordered to pay $7 million in compensatory damages and $25 million in punitive damages.

Few will consider the following facts:

--A claim that Vioxx caused a heart attack after the patient used it for one month has no basis in medical science.

--Large-scale studies of thousands of people using pain killers -- both prescription drugs and over-the-counter ones like Advil and Aleve -- suggest that high-dose, long-term use may increase heart disease risk in susceptible users, but that is a far cry from establishing that a month of using Vioxx caused a heart attack.

--Vioxx is a member of a family of drugs called "Cox 2-inhibitors" that are showing great promise in preventing cancer -- including chemoprevention of cancers of the colon and breast.

--Legal judgments such as the one today can only serve to discourage the continued study of this class of drugs for cancer prevention purposes.

When drug companies are slapped with verdicts claiming their drugs are harmful -- even after years of research and the arduous process of FDA approval -- it can only serve to (a) cause the companies to raise drug prices to compensate for the financial judgments against them and (b) discourage future innovation in life-saving drugs because it simply becomes too costly. Who wants to invest in drug development when, after the enormously expensive and time-consuming FDA approval process, you can still be found liable of selling an allegedly dangerous drug?

Ironically, Merck, found by the jury to have sold a pharmaceutical that caused death in the course of one month of use, is the same company that is about to market a vaccine to protect women from cervical cancer. What if the economic impact of this and other verdicts (the score now is three wins and three losses in court cases against Merck on Vioxx) causes such negative economic fallout at Merck that this life-saving vaccine is not launched in a timely manner?

The time has come to seriously consider

1. establishing , as a routine component of all trials such as these, a "science court" -- a panel of qualified experts in medicine, epidemiology and pharmaceutical sciences -- that can advise juries on issues relating to medical causation. A science court in this Vioxx case would have advised the jury that the use of Vioxx for one month would be highly unlikely to be the cause of the plaintiff's heart attack; and

2. offering pharmaceutical companies limited liability for lawsuits against their newly introduced drugs once they have survived the rigorous FDA approval process. Such protection would enormously benefit American consumers who want new, innovative drugs at affordable prices. It would eliminate the extra "tax" added by the extraordinary cost of junk-science-based lawsuits against the manufactures of useful drugs -- lawsuits that only line the pockets of plaintiffs attorneys.


Elizabeth M. Whelan, Sc.D., MPH, is founder and president of the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com).

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-livin' in the terminally flippant zone

I'll begin by saying that I am a Merck stockholder. Having said that, I get upset at this litigious society in which we live. Peragro raises some good points. These are businesses whose goal is to make money for their shareholders AND to produce a product that will improve the quantity and quality of our lives.

Merck was not forced to pull Vioxx off the market or to announce their internal findings. The FDA approved this drug after very rigorous trials and testing. I wonder if Merck's executives weren't questioning their own sanity after voluntarily opening themselves up to the hell and expenses they've suffered thus far. It appears to me they did the morally right thing. And now the American Trial Lawyers Association and others are punishing them for trying to behave ethically. What kind of message is that? No wonder companies try to hide things like this!

The other companies making this same class of drug have now pulled their competing products off the market, too. Merck seems to be taking most of the heat, though.

Does anybody else see the irony in all of this?

__________________
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First off, I don't work for any of the big pharma companies. We own a little stock in a very small one, but that's it.

The gov't. does nothing to develop or distribute drugs to help the population.
It is all private industry. The mega lawsuits of years ago are the reason there is now less than a handful of quality vaccine makers today. Taking any vaccine requires risk, no matter what. Many 'big pharma' companies just decided "F*** it, it's not worth the financial risk to do this anymore when we develop something wonderful at great expense in R&D, test it, get it FDA approved and one person dies for likely another reason and any profit we may have made is taken out by one huge 'award' for ridiculous millions. Even if we appeal it, the lawyers end up taking all the money. Fine. Instead, we'll make cheap aspirin and a profit. No more innovation."

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Sow of hands for people who would trust the Fed to produce quality drugs at a fair price.

American Council on Science and Health

funded by







wait for it










wait for it








wait for it





Merck Company Foundation

So what's the scientific basis for removing vioxx and other cox-2 inhibitors from the market? If you or someone you know is diagnosed with cancer will you want the cox-2 inhibitor or will you refuse because it's from Merck (immaterial, as it's off the market now).

Is any of the above statement changed because of who funds whom?

My point is that the luddite-hate big pharma-sky is falling-anti technology crowd, coupled with the pit-bull class action litigators have the strong possibility of doing real harm to the general public. The combination of greed and stupidity doesn't seem to be in anyones best interest.

What's your point?

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-livin' in the terminally flippant zone

I should have asked for evidence of past performance, sorry.

My point is that Ms Whalen pulls down $325k a year as a mouthpiece for the food and drug industries. Cox-2 inhibitors have not been pulled of the shelf, you might have noticed a commercial or two for Celebrex, a cox-2 inhibitor.

As for Ms. Whalen's assertion that "A claim that Vioxx caused a heart attack after the patient used it for one month has no basis in medical science." I suppose that Merck will not have a hard time overturning the verdict because obviously the judge was wrong on their summary judgement motion. However, since the jury found that a one month use caused his death, I'm guessing that it's not a "far cry from establishing that a month of using Vioxx caused a heart attack." In fact I'd say that the plaintiff established it pretty well.

Verdicts like this don't discourage companies from making products. They encourage companies to make safe products and to not conceal dangers from the public, as Merck did.

The Pinto case didn't stop Ford from making cars, it stopped them from making exploding cars.

Using your car analogy in terms of Vioxx would be like saying that Chrysler has been successfully sued and is now paying fines and removing minivans from the market because some individuals had problems with them when they drove them consistently and regularly at 120MPH.

I have no problem with lawsuits against drug companies. I have problems with ridiculously high awards based upon little to no factual evidence. There is an add in the local paper today that reads

"Suffer a heart attack or stroke while taking CELEBREX, or BEXTRA or VIOXX? Diagnosed with mesothelioma? You may have a claim worth $250000+. Call 24hrs 1-800-928-0368"

Who paid for that?

anyway, regarding Celebrex... I'm sure you realize that aspirin wouldn't make it to the market today as a new drug. Fortunately it was developed long ago.


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posted on Tue, Apr. 04, 2006


COLON CANCER
Celebrex promising, but raises heart risks
Two studies found that the popular arthritis drug Celebrex may prevent colon cancer, but experts said heart problems were seen in those taking it.
By MARILYNN MARCHIONE
Associated Press

WASHINGTON - Is a drug that might lower the risk of colon cancer worth taking if it also raises the risk of heart problems?

That's a question people most likely to develop the deadly bowel disease may be asking after the latest research on the popular arthritis drug Celebrex was released.

Two studies found that the drug cut the chances of developing precancerous growths called polyps by 33 percent to 45 percent in people who already had such growths removed.

However, experts said the extra heart problems seen in those taking the drug mean that it can't be recommended for preventing cancer in people at average or slightly higher risk.

''We are all concerned about cardiovascular events,'' said Dr. Nadir Arber of Tel Aviv Sourasky Medical Center in Israel, who led one of the studies.

Still, experts were excited by how much potential the drug showed for cancer prevention.

''It lays a huge foundation for the future.'' said Dr. Ernest Hawk of the National Cancer Institute, which paid for one of the studies.

It's an important issue -- more than 145,000 new cases of colorectal cancer and about 55,000 deaths from it are expected to occur this year in the United States.

Worldwide, more than 1 million cases and 529,000 deaths are projected.

The two studies were presented Monday at a conference of the American Association for Cancer Research.

They are the latest chapter in the saga of cox-2 inhibitors, painkillers that block a substance that causes inflammation and also are found in great supply in many tumors.

Aspirin also blocks this substance, and studies suggest that it, too, cuts the risk of colon cancer, but aspirin is very tough on the stomach and can cause bleeding problems.

Doctors hoped that cox-2 inhibitors would be better, but Celebrex is the only one still on the market; Vioxx and Bextra were withdrawn over safety concerns.

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-livin' in the terminally flippant zone

The analogy is wrong. No one accused the dead guy of recklessly abusing the drug.

You make two assertions, one that there was little to no factual evidence and two that the verdict was too high. As to the first, you do not know what factual evidence was presented to the jury. However, there was obviously enough to withstand a Rule 12(b) motion to dismiss, a summary judgement motion, a motion for directed verdict, a motion for judgement not withstanding the verdict and enough to convince a jury.

As to you're second assertion, that the verdict was "ridiculously high" what would be enough? Merck has a market cap of 77 Billion dollars. They had revenues of over 20 Billion last year. How much is enough to deter them from hiding studies that show that Vioxx caused heart attacks. The jury thought the number was 253 million.

The lawyer, who also ponies up all the cost of litigation. Do you know what a products liability or med mal case cost to prosecute? They had literally millions in the vioxx case. A lawyer can't advertise his services? The drug companies certainly do.

No, I don't know that and I suspect you are wrong. However, it won't be proven either way so it's mere speculation.

The world according to peragro.

Several of Big Pharma's products have been invaluable in my life. Penicillin and sundry have been of great help and God only knows what I might have contracted w/o vaccines.

Having said that, way too many people, IMHO, have gotten quick-fix-happy in the oral meds dept.

I hope to God I don't become one of the walking dead who depend on about 20 various meds daily, with who knows what collection of side-effects, with a bill of $500 to $1K monthly going to Big Pharma. A lot of that is up to me, i.e., the sorts of choices I make in diet and lifestyle from here on out. Part of it is merely knowing that some changes are unavoidable.

While the people who developed the big breakthroughs have my eternal respect, the somewhat lower caste that chases big profit through pharma is not so savory.

Prime example #1: various high muckey muck authorities assure us that med. marijuana is utterly w/o value, but just in case it does have value, Eli Lily has a marvy little pill the name of which is derived from mari-ja-hooga: marinol, at only $10 per dose!! That way, people can get relief from their ailments w/o stinking up the house or diverting monies from big pharma into their own pockets.

Is this a great country or what?

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If the pill will kill you must pay the bill.

Nicely done!