Vioxx Taken Off the Market by Merck

[Guest guest]

Jan and Group,

What a development! For details, please see

http://www.vioxx-legal.com/news/vioxx-recall-alert.php

The following is the body text from this web page:

" MERCK WITHDRAWS ARTHRITIS DRUG VIOXX

Dateline: September 30, 2004

NEW YORK (Reuters) – Merck & Co. (MRK.N: Quote, Profile, Research) said on

Thursday it would be withdrawing its arthritis drug Vioxx globally after a

colon cancer trial confirmed long-standing concerns that the drug raises

the risk of heart attack and stroke.

Merck’s shares plunged in pre-market trading after the announcement.

A recent study by the U.S. Food and Drug Administration suggested patients

taking Vioxx faced a 50 percent greater risk of heart attacks and sudden

cardiac death than those taking Pfizer Inc.’s (PFE.N: Quote, Profile,

Research) rival Celebrex treatment.

Vioxx had sales last year of $2.55 billion. They have been flat in recent

years amid ongoing safety concerns.

Merck said it is withdrawing the drug following data from a new three-year

trial of Vioxx, designed to evaluate the effectiveness of the drug’s

standard 25 milligram dose in preventing recurrence of colorectal polyps.

Such polyps often become cancerous.

“In this study, there was an increased relative risk for confirmed

cardiovascular events, such as heart attack and stroke, beginning after 18

months of treatment in the patients taking Vioxx compared to those taking

placebo,” Merck said in a release.

“It’s a major blow for Merck,” said Sena Lund, an analyst at Cathay

Financial. “It was one of their five key drivers for future growth.”

Merck had expected Vioxx to help restore the company’s earnings growth when

the drug was launched in 1999, but its sales have been hurt by clinical

trial data showing it increased the incidence of blood clots tied to

strokes and heart attacks.

Meanwhile, sales of Pfizer Inc.’s similar drugs, Celebrex and Bextra, have

steadily grown as doctors have turned to those drugs, which have not been

linked to heart attack and stroke. "

At 08:40 AM 9/30/2004 -0400, Jan wrote:

>On the Netscape website it said that Merck drug co. is taking VIOXX off

>the market!!! For those that take it, I would call your doctor immediately!

>jan

[Guest guest]

I wonder if the risks stay with you even though you've been off Vioxx for a

couple of years.

Ana

rheumatic Vioxx Taken Off the Market by Merck

> Jan and Group,

>

> What a development! For details, please see

> http://www.vioxx-legal.com/news/vioxx-recall-alert.php

> The following is the body text from this web page:

>

> " MERCK WITHDRAWS ARTHRITIS DRUG VIOXX

> Dateline: September 30, 2004

>

> NEW YORK (Reuters) - Merck & Co. (MRK.N: Quote, Profile, Research) said on

> Thursday it would be withdrawing its arthritis drug Vioxx globally after a

> colon cancer trial confirmed long-standing concerns that the drug raises

> the risk of heart attack and stroke.

>

> Merck's shares plunged in pre-market trading after the announcement.

>

> A recent study by the U.S. Food and Drug Administration suggested patients

> taking Vioxx faced a 50 percent greater risk of heart attacks and sudden

> cardiac death than those taking Pfizer Inc.'s (PFE.N: Quote, Profile,

> Research) rival Celebrex treatment.

>

> Vioxx had sales last year of $2.55 billion. They have been flat in recent

> years amid ongoing safety concerns.

>

> Merck said it is withdrawing the drug following data from a new three-year

> trial of Vioxx, designed to evaluate the effectiveness of the drug's

> standard 25 milligram dose in preventing recurrence of colorectal polyps.

> Such polyps often become cancerous.

>

> " In this study, there was an increased relative risk for confirmed

> cardiovascular events, such as heart attack and stroke, beginning after 18

> months of treatment in the patients taking Vioxx compared to those taking

> placebo, " Merck said in a release.

>

> " It's a major blow for Merck, " said Sena Lund, an analyst at Cathay

> Financial. " It was one of their five key drivers for future growth. "

>

> Merck had expected Vioxx to help restore the company's earnings growth

> when

> the drug was launched in 1999, but its sales have been hurt by clinical

> trial data showing it increased the incidence of blood clots tied to

> strokes and heart attacks.

>

> Meanwhile, sales of Pfizer Inc.'s similar drugs, Celebrex and Bextra, have

> steadily grown as doctors have turned to those drugs, which have not been

> linked to heart attack and stroke. "

>

>

> At 08:40 AM 9/30/2004 -0400, Jan wrote:

>

>>On the Netscape website it said that Merck drug co. is taking VIOXX off

>>the market!!! For those that take it, I would call your doctor

>>immediately!

>>jan

>

>

>

>

> To unsubscribe, email: rheumatic-unsubscribeegroups

>

>

[Guest guest]

.....For the first 18 months in the drug there was no increased risk in

using vioxx. The risk only appeared after 36 months. It is obviously

cummulative. If you were on it for 18 months or less you have no increased

risk.

If you were on it longer but have been off for a long time, I would venture

to guess you probably are one that would not have a problem. Next time you

go to your doc you can add it to your question list. You might also ask your

local pharmacist what he thinks. Martha

[Guest guest]

Dear Group,

This lengthy article began on the front page of today's Los Angeles Times:

ARTHRITIS DRUG VIOXX PULLED;

RISK OF HEART ATTACKS IS CITED

By H. Maugh II and Gellene, Times Staff Writers

Merck & Co. voluntarily withdrew its blockbuster arthritis drug Vioxx from

the market Thursday after a new study showed that it nearly doubled the

risk of heart attacks and strokes among people taking it for at least 18

months or longer.

The loss of the drug, which has worldwide sales of nearly $2.5 billion per

year, represents a major financial setback for Merck, which lost almost $27

billion in stock market value in a matter of hours.

Physicians recommended that patients taking the drugs about 2 million

worldwide talk to their doctors and switch to other medications. Merck

said it would set up a program to buy back unused supplies of Vioxx.

" We are taking this action because we believe it best serves the interest

of patients, " Merck Chairman Ray V. Gilmartin said in announcing the recall.

Although the timing of the announcement was unexpected, the withdrawal does

not come as a complete surprise because " earlier studies had already raised

this concern, " said Dr. Gregg C. Fonarow, a cardiologist at UCLA Medical

Center. " There was already a movement away from Vioxx, but there are still

a large number of people being treated with it. "

Experts said the risk of life-threatening events was small and that the

findings probably did not apply to other members of the class of drugs

called -2 inhibitors. Nonetheless, the Food and Drug Administration said

Thursday that it would reexamine all similar drugs on the market and could

require additional data for new drugs in the same class.

The Merck announcement sent many patients to their physicians in fear for

their health and their ability to control severe pain.

" If you get off Vioxx and still have pain, there are five to seven other

[drugs] that people need to work their way through to find something that

is effective, " said Dr. Abramson of the New York University School

of Medicine.

The most immediate beneficiary will be Pfizer Inc.'s -2 inhibitor

Celebrex, which is projected to have worldwide sales of at least $3.3

billion this year. Pfizer also has a second-generation drug called Bextra,

which has projected sales of about $600 million, and Merck has a

second-generation drug called Arcoxia that has been approved in 47

countries but is awaiting approval from the FDA.

The FDA had delayed its decision on Arcoxia because of earlier concerns

about Vioxx, and the new results seem likely to delay it further and make

it more difficult for other drugs of the class to reach the market, experts

said.

In particular, the agency seems likely to require longer clinical trials

before approval, because the new risks did not develop until after 18

months of use. But the FDA has not decided how it will approach the

problem, said , director of the FDA's office of new drugs.

The agency requires trials of six to 12 months for drugs treating chronic

diseases, he said, adding that " it is difficult to ask an arthritis patient

who has inflammation and pain to remain in a longer-term,

placebo-controlled trial. "

Steve Galson, acting director of the FDA's Center for Drug Evaluation and

Research, said: " I am sure we are going to ask for more data, but I can't

tell you exactly what that data is. "

-2 inhibitors have been extremely popular since they were first

introduced in 1999. Their chief advantage is that, unlike aspirin,

ibuprofen and other over-the-counter drugs for inflammation, they do not

cause gastrointestinal bleeding. Their principal drawback is cost, about $3

per day, compared with about 3 cents per day for aspirin or ibuprofen.

In the United States, more than 84 million prescriptions for Vioxx have

been written since its introduction. Most of the prescriptions are for

long-term treatment of the chronic pain and inflammation of osteoarthritis

and rheumatoid arthritis, but the drug is also used widely for short-term

treatment of many types of pain.

To obtain FDA approval, Merck tested the drug in clinical trials involving

3,900 patients. Although the study found an increase in high blood pressure

cases, there was no sign of the drug causing heart attacks. The company's

final study required for FDA approval lasted 12 months.

But a 2001 report in the Journal of the American Medical Assn. found signs

that the drug might increase cardiovascular risks, and the FDA required a

warning on the drug's label.

The new findings came in a three-year study funded by Merck to determine

whether Vioxx could retard the progression of colon polyps into full-blown

cancer. It is the longest study of a -2 inhibitor that has been

conducted so far.

Merck stopped the trial prematurely Sept. 23 when the trial's external

data-monitoring board alerted the company to a potential problem. At that

point, 25 of 1,299 patients receiving a placebo had suffered a heart attack

(1.9%), compared with 45 of the 1,287 patients receiving Vioxx (3.5%),

according to a Merck spokesman.

The number of deaths in each group was the same: five.

No one is sure why the drug triggered the heart attacks, but speculation

includes an increase in blood pressure and a slight hardening of arterial

walls leading to increased clot formation. There is no evidence that any of

the changes are permanent, Fonarow said, and the cardiovascular risk of

patients who stop taking the drugs or who took them only for short periods

should return to normal.

On Wall Street, investors punished Merck's shares, sending them down 27% to

$33, off $12.07 in trading on the New York Stock Exchange.

Pfizer shares rose 42 cents to $30.60, also on the New York Stock Exchange.

Analysts were divided on how the withdrawal of Vioxx would affect sales of

Pfizer's Celebrex and Bextra. Some thought the drugs would benefit; others

thought Vioxx's demise would hurt the entire category of drugs.

" Bad news for a key product is never good news for a class of drugs, " said

, a pharmaceutical industry analyst with Goldman Sachs in New

York. He noted that sales of all anti-cholesterol drugs suffered when drug

maker Bayer withdrew Baycol in 2001 after it was linked to 31 deaths.

said recent drug sales showed an increased use of over-the-counter

painkillers, reflecting mounting concerns about -2 drugs.

Sena Lund, an analyst with Cathay Financial in New York, agreed that

aspirin and other over-the-counter pain relievers would benefit. But he

predicted that a " major portion " of Vioxx's sales would go to Celebrex and

Bextra.

Legal experts said Merck could face lawsuits from patients who believed

they were harmed by Vioxx, but that it was too early to quantify the

company's potential liability.

Brietta of Loyola Law School in Los Angeles said lawyers had already

started to look for Vioxx patients on the Internet. " Clearly, a lot of

people think they have got a basis for a suit, " she said.

said the fact that Merck recalled Vioxx would work in the company's

favor.

Zasloff, a UCLA law professor, said it would be difficult for

plaintiffs to prove that Vioxx caused their heart attacks.

" The easiest kind of cases involve a signature disease, like asbestosis, "

he said. " To show that Vioxx caused your heart attack is going to be a hard

sell. "