Pfizer Statements RE: Bextra, Celebrex, Neurontin Shown to be Lies

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[sSRI-Research] Pfizer Statements RE: Bextra, Celebrex,

Neurontin Shown to be Lies

 

 

 

Pfizer Statements RE: Bextra, Celebrex, Neurontin Shown to be Lies

 

Fri, 08 Apr 2005

 

The New York Times reports that " as recently as Tuesday [Pfizer]

assured Wall Street that sales of Celebrex and Bextra would soon

rebound. It was the latest in a string of announcements by the

company regarding the two drugs that quickly proved untrue. "

 

But the FDA's announcement on Thursday that Pfizer's pain killer

drug, Bextra, was being removed from the market because of rare skin

rash is being challenged by Dr. Alistair Wood, chairman of FDA's

advisory panel that examined the evidence and concluded that Vioxx,

Bextra and Celebrex (in that order) posed serious risk of cardiac

arrest --not skin rash.

 

Dr. Wood, one of the very few advisory panel members who does not

have a conflict of interest, disputed the assertion by Dr. Steven

Galson, acting director of the F.D.A.'s center for drugs, that skin

rash was the cause for withdrawal.

 

Furthermore, Dr. Wood recognizes that FDA's latest maneuver-namely,

to put the same warning label on all drugs within a class-e.g., all

antidepressants, all pain killers-even though evidence exists for

particular, patented drugs only-serves to trivialize the severity of

the lethal risks that is demonstrated by the evidence.

 

Dr. Galson is disregarding the evaluation of FDA's advisory committee

when he states: " We think these risks apply to all of these drugs.

There may be some differences, but our conclusion is that we don't

have enough data to rank-order these risks. "

 

Furthermore, the FDA appears to be reversing FDA's policy of

rendering decions that are " science-based. " Documented evidence

indicates that Neurontin poses a serious suicide risk. In May 2004,

Pfizer pled guilty to criminal misbranding Neurontin in promotional

and advertising material suggesting that " the drug is safe and

effective for uses which have not been approved by the FDA. "

 

How much evidence does the FDA need before it issues warnings? How

many preventable deaths will FDA officials have on their consciences?

 

Contact: Vera Hassner Sharav

212-595-8974

 

 

THE NEW YORK TIMES

April 8, 2005

F.D.A. Announces Strong Warnings for Painkillers

By GARDINER HARRIS

 

WASHINGTON, April 7 - Federal drug regulators issued sweeping

warnings Thursday that many popular painkillers could hurt the heart,

stomach or skin, and they persuaded Pfizer to withdraw its pain pill

Bextra, once a strong seller.

 

Tough warnings about heart risks will soon dominate the labels for

prescription painkillers like Celebrex, Mobic, Naprosyn, Voltaren and

more than a dozen other similar drugs, the Food and Drug

Administration announced. Even the labels of popular over-the-counter

pills like Advil and Aleve will have to cite risks to heart, stomach

and skin, the agency said.

 

Few studies have examined the long-term health effects of most of

these medicines, so regulators are groping a bit in the dark. Studies

done on Bextra and Celebrex, both from Pfizer, and Vioxx, made by

Merck, strongly suggest that they increase the risks of heart attacks

and strokes. With those studies in hand and suggestions that older

pills may act similarly, F.D.A. officials said that they could not

rule out the possibility that all of the drugs in the class known as

nonsteroidal anti-inflammatories cause similar problems. Several

doctors interviewed said they would now weigh the risks and benefits

case by case. [Page C4.]

 

" We think these risks apply to all of these drugs, " said Dr. Steven

Galson, acting director of the F.D.A.'s center for drugs. " There may

be some differences, but our conclusion is that we don't have enough

data to rank-order these risks. "

 

Still, Dr. Galson emphasized that popular over-the-counter pain pills

were safe if taken briefly and in low doses, and patients should not

suddenly stop taking these medicines because of the F.D.A.'s

announcement. Several experts said that naproxen, the medicine found

in Naprosyn and Aleve, is probably the safest among the nonsteroidal

pain pills.

 

Neither acetaminophen, sold as Tylenol and other names, nor aspirin

are affected by the new warnings, although those medicines are not

problem-free. In high doses, aspirin can hurt the stomach and Tylenol

can damage the liver. Aspirin, though, protects the heart.

 

The latest warnings will complicate prescribing decisions for

arthritis patients and others in chronic pain. There are hints in the

research that the pain pills that are easiest on the stomach may be

toughest on the heart, and vice versa. Aspirin, for instance,

protects the heart but can irritate the stomach. Naproxen may be

mildly protective to the heart but seems especially harsh on the

stomach. Vioxx proved easiest on the stomach but probably has the

most toxic effects on the heart. All, in rare cases, cause skin

reactions.

 

Doctors must now ask about a patient's heart and stomach risks. Those

with cardiovascular problems could get one kind of pill, and those

with a history of ulcers may get another. And some drugs have

uniquely beneficial effects in some patients, who may prefer to

accept a measure of risk to continue taking their favored drug. The

difficulties may be particularly acute for the elderly, who are often

at risk for stomach and heart problems.

 

Pfizer said in a statement that it " respectfully disagrees with

F.D.A.'s position regarding the overall risk-benefit profile of

Bextra, " but it agreed to suspend sales of the drug. The company said

it would work with the agency to come up with a strongly worded

warning for Celebrex.

 

Pfizer has agreed to undertake a large study of Celebrex's effects on

the heart, the agency said. The F.D.A. has asked manufacturers of

other pain pills to re-evaluate studies of their pills' effects on

the heart. The F.D.A. has no authority to force drug makers to

undertake trials of approved medicines.

 

The F.D.A.'s decision to force Bextra's withdrawal could prove a balm

to widespread criticism, arising from a series of drug scandals, that

the agency has been too lax. Senator Edward M. Kennedy, a

Massachusetts Democrat, praised the agency's action. " No patients

should have to worry that the pill they take may put them at

unacceptable risk, " he said.

 

Senator Charles E. Grassley, an Iowa Republican who has overseen

hearings that were acutely embarrassing to the agency, said that the

action would be good news if it " is a turning point and indicates a

more independent Food and Drug Administration. " Still, Mr. Grassley

noted that the agency continued to defend its approval and actions

around Vioxx, which he said was " hard to square " with its decision to

force Bextra's withdrawal. Merck withdrew Vioxx in September after a

study showed that it more than doubled the risk of heart attacks and

stroke.

 

Merck has said it may ask to start selling Vioxx again; the F.D.A.

has said any such application would be reviewed by an advisory

committee.

 

Dr. Galson said that information about drugs evolves as studies are

completed " and we feel very strongly that we have taken account of

these as quickly as possible. "

 

" The medical and public health community should have confidence in

the F.D.A. in light of these changes, " Dr. Galson said.

 

F.D.A. officials have acknowledged that they are almost entirely

unable to discover whether popular drugs cause common problems like

heart attacks, which can arise from a variety of causes. Dr. Paul

Seligman, a top F.D.A. drug safety official, said that the agency was

trying to improve, but uncovering such effects was a challenge.

 

Celebrex, Bextra and Vioxx were, as recently as last year, among the

top drugs in the world in sales. All are part of a new class of drugs

called cox-2 inhibitors that were supposed to be safer on the stomach

than older pain pills. But Celebrex and Bextra never proved any safer

to the stomach, and some researchers say they believe that all three

drugs were designed in ways that make them especially toxic to the

heart. None of the three has been proved to ease pain any better than

older pills.

 

In February, the F.D.A. asked a committee of experts whether it

should force the withdrawal of Bextra and Celebrex and keep Vioxx off

the market.

 

The committee voted overwhelmingly to keep Celebrex on the market but

only narrowly supported continued sales of Bextra and Vioxx. Dr.

Galson said that the agency's decision to press Pfizer to withdraw

Bextra was " consistent with the views of many people on the panel. "

 

Dr. Galson explained that the F.D.A. pushed for the withdrawal of

Bextra largely because the drug causes a rare, life-threatening skin

reaction more often than other pain pills and had no other unique

benefits. This explanation surprised many on the panel, whose

deliberations focused almost entirely on Bextra's effects on the

heart and largely ignored its rare but serious effects on the skin.

 

Dr. Alastair Wood, the panel's chairman, said that F.D.A. officials

told him and others early Thursday morning that the agency asked for

the withdrawal of Bextra because of its effects on the heart, not the

skin.

 

Dr. Wood also said he worried that the agency's decision to require

tough warnings on all prescription painkillers might suggest to some

physicians and patients that the worries about Celebrex were not

unusual.

 

" By labeling everything, you might be trivializing the label on

Celebrex, " Dr. Wood said.

 

Physicians and patients should largely avoid Celebrex, Dr. Wood said,

because the evidence is clear that it causes heart problems. Patients

who need pain therapy should start with naproxen, the medicine found

in Naprosyn and Aleve, he said. If their stomach hurts, they could

take an over-the-counter heartburn pill like Prilosec, he said. They

should try several other painkillers before considering Celebrex, he

said.

 

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who served

on the panel, also recommended that patients start with naproxen and,

if their stomach hurts, take Prilosec. Few should take Celebrex, he

said.

 

The F.D.A.'s announcement was yet another blow to Pfizer, which as

recently as Tuesday assured Wall Street that sales of Celebrex and

Bextra would soon rebound. It was the latest in a string of

announcements by the company regarding the two drugs that quickly

proved untrue.

 

Last fall, Pfizer repeatedly insisted that it knew of no studies of

either Celebrex and Bextra that showed that the drugs hurt the heart.

It later admitted that it had sponsored studies on both drugs that

showed worrisome heart effects. Coping with slumping sales and

earnings, Pfizer is entering a period during which many of its

biggest selling drugs will face generic competition.

 

Pfizer suspended its enormous advertising campaign for Celebrex last

fall when worries about the drug first surfaced. The February

advisory panel voted overwhelmingly that the company should never

again advertise the drug. But F.D.A. officials said that they could

not ban the advertising of any drug.

 

Dr. Galson said that any new ads for Celebrex would have

to " acknowledge the new risks. " Indeed, being forced to alert

consumers about serious health risks often dissuades drug companies

from any advertising. Still, Dr. Galson said that banning ads for one

drug made little sense when similar pain pills have similar risks.

 

Longtime critics of the agency said Thursday that they were still

unhappy. Dr. Sidney Wolfe, a director of Public Citizen, said that

the F.D.A. should have forced Celebrex's withdrawal as well. And its

contention that it sought the withdrawal of Bextra because of its

rare effects on the skin " is ludicrous. "

 

Doug Bandow, a senior fellow at the Cato Institute, said that the

agency should have left Bextra on the market with appropriate

warnings about its risks. " For patients, it's always better to have

more choice than less, " he said.

 

Copyright 2005 The New York Times Company

 

http://www.nytimes.com/2005/04/08/business/08pfizer.html?

pagewanted=print & position=

 

April 8, 2005

NEWS ANALYSIS

Pfizer Loses One Remedy for Its Slump

By ALEX BERENSON

 

In a meeting with investors just three days ago, Pfizer executives

repeatedly promised that Bextra, a painkiller that generated $1.3

billion in sales last year, would help the company through a

difficult transition period. Guess again.

 

The Food and Drug Administration forced Pfizer yesterday to stop

selling Bextra, citing concerns that the drug can cause a dangerous

skin condition and is at least as dangerous to the heart as other

painkillers. The F.D.A. also said that it would require Celebrex,

another Pfizer painkiller in the same class of drugs, to carry a

prominent warning of possible heart risks. That warning could hinder

Pfizer's plans to revive Celebrex's flagging sales.

 

For Pfizer, the world's largest drug company, the forced withdrawal

of Bextra is another blot on its image at a moment when Pfizer is

already suffering from stagnant sales and slumping profits. Together,

Celebrex and Bextra totaled $4.5 billion in sales last year, 9

percent of Pfizer's total.

 

Yesterday's withdrawal also raises questions about whether Pfizer's

management is attuned enough to the newly aggressive F.D.A., which is

under pressure from lawmakers and consumer groups to move quickly

against potentially dangerous drugs.

 

But investors are betting that the withdrawal damages Pfizer's

reputation more than its profits. After dumping Pfizer stock

yesterday morning when the F.D.A. announced its action, investors had

changed their minds by day's end. On a generally strong day for

stocks, Pfizer ended trading up 4 cents, or 0.15 percent, to $26.90.

 

Analysts said that the initial 4 percent drop in the stock was driven

mainly by investors concerned that the withdrawal of Bextra would

open Pfizer to lawsuits from people who had taken the drug and

suffered heart attacks or strokes. But the F.D.A. blamed the skin

rash, not heart problems, for its decision to force Bextra off the

market. So while the withdrawal did prompt new plaintiff suits

yesterday, it probably will not weaken Pfizer's legal position,

analysts said. " Bextra's being pulled due to a side effect that is

not common, " said Tony Butler, an analyst at Lehman Brothers.

 

Mr. Butler noted that the F.D.A. also said yesterday that it would

require many other painkillers to carry warnings similar to those on

Celebrex. That could help Celebrex sales by diluting some of the

stigma on the drug since last fall when it and the other so-called

cox-2 inhibitors, Bextra and Vioxx, came under scrutiny for their

cardiovascular risks.

 

Still, yesterday's announcement does little to improve Pfizer's

credibility at a time when some investors want the company to be more

forthcoming about its plan to cut $4 billion, or 12 percent, of its

annual costs by 2008.

 

Pfizer said yesterday that it had learned only after a Tuesday

investor meeting that the F.D.A. planned to force it to withdraw

Bextra. Pfizer said it disagreed with the decision but would suspend

sales pending further discussions with the agency. Even before the

F.D.A.'s action, though, many analysts had said that Pfizer's

optimism about Bextra and Celebrex was misguided. Studies have linked

both cox-2 drugs to serious heart problems, and neither medicine has

ever been shown to be more effective than older and cheaper medicines

at treating pain. Sales of both drugs this year had already plunged.

 

" They should have refrained from being bullish on the coxib drugs, "

said Jami Rubin, an analyst at Morgan Stanley, using industry

shorthand for cox-2 inhibitors. " Maybe they should have waited to

hold the meeting until they had a final decision from the F.D.A. "

 

Besides its cox-2 issues, the company has other problems. Pfizer -

which had $52.5 billion in sales and $16 billion in profits last

year, before certain one-time charges - faces patent expirations that

will cost it $14 billion in annual sales in the next three years. It

loses American patent protection on Zoloft, an antidepressant that is

its third-best seller, in 2006, and on Norvasc, a blood pressure

medicine that is its second-biggest seller, in 2007.

 

At Tuesday's meeting, the company said that its profits would fall to

$2 a share in 2005 from $2.13 in 2004, excluding certain one-time

charges. But Pfizer assured investors that earnings per share - again

excluding certain charges - would grow by more than 10 percent in

2006 and 2007, and that Celebrex and Bextra would play a crucial part

in that growth. A spokesman for Pfizer said yesterday that the

company was still reviewing how much Bextra's absence would hurt its

profits. Before the withdrawal, analysts had predicted that Bextra

would account for $200 million to $400 million in after-tax profits

for Pfizer in 2005, or 3 to 5 cents a share.

 

Moody's Investors Service said yesterday afternoon that it had placed

Pfizer's bonds under review for a possible ratings downgrade, citing

the loss of Bextra, the likely reduction of Celebrex sales, the

patent expirations and generally rough times for the drug industry.

The bonds now carry a rating of Aaa, the highest possible. A ratings

downgrade would not seriously hurt Pfizer's business or its profits.

The company is flush with cash. But a downgrade would be one more

embarrassment for a company that not too long ago seemed unstoppable.

 

Copyright 200 The New York Times Company

 

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