from another source, it apepars the pay ut to plaintiffs, will be approx.
$220,000.


Merck's Quasi-Victory
November 10, 2007; Page A10
There are times when discretion is better for business than valor -- and so it probably is with Merck's decision yesterday to settle the legal battle over Vioxx for what amounts to the bargain price of $4.85 billion.

If that figure sounds expensive, remember that this was a liability once forecast to threaten the life of Merck itself. By committing to fight each and every individual case, rather than pre-emptively surrender to a mass class action, the company has saved itself billions from the clutches of the tort bar. Plaintiff lawyers were obliged to prove in court that Vioxx caused a particular client's heart attack or stroke, and often the evidence wasn't there. The media hysteria correspondingly petered out.

Another turning point came with the denial of class-action status to Vioxx plaintiffs both in a federal court last November and in the New Jersey Supreme Court this fall. With those victories, Merck was able to sidestep the kind of catastrophic class-action risk that had trial lawyers salivating.

At the time of this week's settlement, Merck's record in federal court was four wins and one loss, while it was 7-and-4 in state courts. The number of new cases had decreased and the rate of dismissals was on the rise. So while management had to weigh the psychic value of future vindication against the bottom line, there are other ancillary payoffs to the settlement.

One is helping to rehabilitate the Vioxx name and removing the drug's notoriety as a sticking point for investors. On news of the settlement, Merck shares were up 2% when the market closed on Friday. Merck's early decision to pull the drug off the shelves may have been the cautious choice, but ample evidence has since emerged that Vioxx is a good drug when used for the right reasons.

The small cardiovascular risk posed by Vioxx, as revealed in Merck's own trials, was only seen in patients who used the drug continually for a year and half. That didn't stop many who'd only used it for days or weeks from getting in line to sue. But the evidence was strong enough that an FDA advisory panel in 2005 recommended that the drug, with a new safety label, go back on the market.

Meanwhile, doctors in specialties from orthopedics to geriatric medicine continue to see such Cox-2 inhibitors as an important option for those who don't tolerate similar drugs that are tougher on the stomach. For other patients with hip and knee problems, drugs like Vioxx can provide pain relief that replaces or delays the need for surgery.

Merck's legal strategy served its shareholders well in the end, reducing a liability once estimated by some Wall Street analysts as high as $30 billion. In settling, the company weighed the $4.85 billion, plus the benefits of more legal certainty, against annual litigation costs running at more than $500 million to fight a backlog of cases with some 47,000 plaintiffs.

Merck management still has a drug business to run and the settlement will reduce its legal distractions. We have no doubt that the company has been hearing all along from doctors and patients who would like to have Vioxx restored as a treatment option. Let's hope that's another result of yesterday's quasi-victory.

Free Article - WSJ.com

__________________
No individual can plan his own existence in their view.

So the state planners must arrogate to themselves the right to manipulate any sector of the economic system if the good of “society” or the “general welfare” is paramount.

Ipso- if the rights of the individual get in the way, the rights of the individual must be sublimated.

The Road to Serfdom
FA Hayek (interpretation)


Mortgage Backed Security survivor

COX-2 inhibitors are a major pharmacological breakthrough. They have helped an enormous amount of patients, if the physicians prescribing them pay atention to the warnings issued by the owners of the drugs. Merck followed the FDA guidelines for releasing the drug.

It is a shame that the media turned it into such a crusade against pharma in general.

As the chemists of pharma who are involved in drug development spend at least 16 years in school, then likely have a two or three year post doc before getting the position in pharma for drug development, they still have relatively small salaries - only about $75K-80K starting out. The project teams are typically 10-15 chemists. This is just to start the development.

Then there are the in vitro tests. Many of the chemists projects get weeded out here. If the project makes it past this stage, then there are the in vivo tests. This still filters out many projects. At this point, several years have been invested.

If the project makes it through the in vivo stage, it goes to clinical trials. This happens perhaps 10-12 years after the benchtop discovery.

So, considering the amount of time and investment put into getting a drug to market and following the FDA requirements for complete testing, is it any wonder the drugs are costly? Contrary to popular belief, the marketing costs are not simply because pharma is greedy, although it does sound good; marketing is needed to recover long-term R&D costs for the little lifetime left on pharma's intellectual property.

Just food for thought for those who simply like to state that pharma is greedy and doesn't care about the patient.

__________________
I am an American. That's the way most of us put it, just matter of factly. They are plain words, those four: you could write them on your thumbnail, or sweep them clear across this bright autumn sky. But remember too, that they are more than just words. They are a way of life. So whenever you speak them; speak them firmly, speak them proudly, speak them gratefully. I am an American. ...a tradition

agreed...

__________________
No individual can plan his own existence in their view.

So the state planners must arrogate to themselves the right to manipulate any sector of the economic system if the good of “society” or the “general welfare” is paramount.

Ipso- if the rights of the individual get in the way, the rights of the individual must be sublimated.

The Road to Serfdom
FA Hayek (interpretation)


Mortgage Backed Security survivor

Not like the good old days when Massengill could sell cherry flavored anti-freeze.

__________________
“ The subjects of every state ought to contribute towards the support of the government, as nearly as possible, in proportion to their respective abilities; that is, in proportion to the revenue which they respectively enjoy under the protection of the state.”

Adam Smith , The Wealth of Nations 1776

"We have always known that heedless self-interest was bad morals; we know now that it is bad economics"
FDR's second Inaugural Address

You should read Overdosed America to learn how big pharma skews trial results and is allowed by the FDA to submit a synopsis of the trials rather than every detail of their research and trials.

Whereas is Canada and Europe, these governments demand that pharmaceuticals submit every detail of their research and trials for review so the efficacy can be determined objectively and not by a skewed pharma synopsis.

Amazon.com: Overdosed America: The Broken Promise of American Medicine: Books: John Abramson

I can assure you that one read of this book will reveal the dubious practices of big pharma to you. The book will also explain why direct-to-consume advertising of drugs is dangerous and why it's not allowed in Canada and most countries in Europe.

Big pharma are not the saints you perceive them to be. Their commitment is to their shareholders and profit is king even if it means people die.

And I can assure you, as one who is in the drug development business, that book is full of falsehoods.

__________________
I am an American. That's the way most of us put it, just matter of factly. They are plain words, those four: you could write them on your thumbnail, or sweep them clear across this bright autumn sky. But remember too, that they are more than just words. They are a way of life. So whenever you speak them; speak them firmly, speak them proudly, speak them gratefully. I am an American. ...a tradition

Have you read it? I'm guessing that you haven't because the book is extremely meticulous in its research and fact-finding.

Dr. Abramson took three years to study the real data from clinical trials of drugs and compared the real data to the skewed statistical data that pharmaceuticals submitted to the FDA and to giant PR machines. He has a background is statistics and his research was corroborated by other Harvard statisticians. Here's an excellent excerpt from the book:

Overdosed America By Dr. John Abramson

Chapter 13

In 1995, Fosamax, the brand name for alendronate, was the first of the new generation of drugs approved by the FDA for the treatment of osteoporosis. Fosamax works by attaching itself to the surface of bone, interposed between the osteoclasts and the bone the osteoclasts are trying to absorb. Randomized clinical trials of Fosamax published in medical journals show dramatic reductions in the relative risk of hip fracture for women with osteoporosis. In a study published in JAMA in 1998, for example, women with an average age of 68 and a T score of - 2.5 or less who took Fosamax for four years were 56 percent less likely to suffer a hip fracture than women in the control group.

This sounds like very good news for women with osteoporosis, but how many hip fractures were really prevented? With no drug therapy at all, women with osteoporosis had a 99.5 percent chance of making it through each year without a hip fracture -- pretty good odds. With drug therapy, their odds improved to 99.8 percent. In other words, taking the drugs decreased their risk of hip fracture from 0.5 percent per year to 0.2 percent per year. This tiny decrease in absolute risk translates into the study's reported 56 percent reduction in relative risk. The bottom line is that 81 women with osteoporosis have to take Fosamax for 4.2 years, at a cost of more than $300,000, to prevent one hip fracture. (This benefit does not include a reduction of less serious fractures, including wrist and vertebral fractures. Most vertebral fractures cause no symptoms.)

[. . . ]

What about using these drugs to prevent osteoporosis? Fosamax and Actonel were approved by the FDA to treat women with osteopenia based on studies that showed that they significantly increase the bone density of these women. It is important to remember, however, that bone density is only a surrogate end point; the real reason for taking these drugs is to reduce fractures, and hip fractures in particular. The study of Fosamax published in JAMA in 1998 (mentioned earlier) also included women with osteopenia. Did Fosamax reduce their risk of fracture? The results show that the risk of hip fractures actually went up 84 percent with Fosamax treatment.* The risk of wrist fractures increased by about 50 percent (that figure may be statistically significant -- but this can't be determined from the data as presented in the article).


How can it be that drugs approved for the prevention and treatment of osteoporosis succeed in increasing bone density but have such limited impact on reducing hip fractures? The answer can only inspire awe at Mother Nature's elegance. There are two types of bone. Eighty percent of the body's bone is made up of the hard and dense outer layer called cortical bone. In some areas of the body, bones also have an internal structure of trabecular bone, which works like an organic three-dimensional geodesic dome, providing additional strength in the areas of the skeleton most vulnerable to fracture, such as the hips, wrists, and spine.

The lacelike structure of trabecular bone creates a much greater surface area than the densely packed cortical bone and therefore allows the former to be more metabolically active when the body needs calcium. Its greater metabolic activity also makes trabecular bone more vulnerable than cortical bone to the changed balance between osteoclast and osteoblast activity. As a result, when bone mass starts to decline in women, trabecular bone is lost more quickly than is cortical bone. Once the architecture of these internal struts is lost, there is no structure left onto which calcium can be added. (See Figure 13-1.) The new bone, formed as a result of taking the osteoporosis drugs, is then formed primarily on the outer part of the bone, the cortical bone. This increases the score on the bone density test but does not necessarily contribute proportionately to fracture resistance.

Here are other endorsements for the book:

American Medical Association, Allan S. Detsky

This book (or one like it) should be required reading for all medical students and doctors, who should be well informed about the potential for bias introduced by the conflicts of interest Abramson delineates. The book may also help patients if it turns the tide against a system that "leads patients to demand that a doctor prescribe a drug that provides no better relief and causes significantly more serious side effects" (p 36) at a substantially higher price and teaches people to understand what the phrase "ask your doctor" really means.

Letter from a physician (02/05/05)

I loved your book. In 1964, I edited The Bulletin of Drug Reactions in Neurology and Psychiatry. The American Psychiatric Association would not accept a paid ad by us, looking for subscribers. I called Walter Barton, MD, medical director of the APA. He told me: "The drug companies pay us a lot of money to advertise. They won't like your publication. We will not accept your ad." Forty years ago, my own APA was a whore for the drug industry.

Thomas P. Lowry, MD

I took Vioxx and had heart failure. Saved by a stent. Did not sue!