Pfizer - zu Unrecht im Keller

Vioxx, Celebrex, and Bextra belong to a particularly controversial subset of NSAIDs called Cox-2 inhibitors. Cox-2 drugs were once considered superiod to NSAIDs because they don't cause the stomach bleeding or ulcers associated with long-term use of other NSAIDs.

Vioxx is no longer on the market while Arcoxia and Prexige have yet to be approved.

Merck stunned the healthcare industry in September when it abruptly yanked its highly popular pain reliever Vioxx from the market after a clinical study linked long-term use to a higher incidence of stroke and heart attack.

Since that time, several other studies have emerged linking other pain relievers-- namely Celebrex, Bextra and naproxen-- to cardiovascular problems. Many medical experts have also noted that an increasing amount of data indicates many NSAIDs can raise blood pressure, especially when taken in higher doses. High blood pressure is a major contributor to cardiovascular problems.

As a result, the FDA panel will be voting on whether to require NSAIDs to carry warning labels advising patients and doctors that they should be used with caution by patients who might be at risk of developing cardiac problems. The panel will also be voting as to whether to request that additional cardiovascular safety studies be run on the drugs.

But of most interest to the pharmaceutical community will be Friday's dealings, when the panel is scheduled to vote on whether to recommend that Bextra and Celebrex be removed from the market. The panel will also vote on whether to formally rescind Vioxx's approval, even though the drug is no longer on the market in the U.S. All three drugs are still available in the European Union.

Traditionally, the FDA has followed the recommendations of its advisory panels.

The advisory panels were concluding a three-day meeting Friday in which they have been assessing drugs known as Cox-2 inhibitors, which also include Pfizer Inc.'s Celebrex and Bextra, to determine whether they are all risky and, if so, whether they have balancing benefits.

All three drugs have been approved for sale by the government. The committees' recommendations could be the first steps toward rescinding those approvals.

Meeting chairman Alistair J.J. Wood of Vanderbilt University Medical School asked whether the drugs could win approval today, considering the studies that have come to light in recent months.

Kim indicated a positive assessment by the committees might lead Merck to consider bringing Vioxx back onto the market.

If the committees and the FDA conclude that the benefits of this class of drugs outweigh the risks for some patients, "then we would have to consider the implications of these new data" for Vioxx, Kim said.

Asked if he meant the company would consider returning Vioxx to the market, Kim said: "There are unique benefits to Vioxx. The science has progressed and we need to take that science into consideration."

While the committees heard evidence that all drugs in the group can increase the risk of heart attacks, irregular heart beat and strokes, it did note that Vioxx seemed to have more such reports than the other drugs.

On the other hand, Kim pointed out that Vioxx is the only one of the drugs approved for people with certain allergies and did better at preventing the stomach and intestinal problems often caused by over-the-counter painkillers.

Committee members will be asked their opinion on whether all the drugs pose a problem and what should be done. Their recommendations could include increasing warnings, seeking more studies, limiting who can use the drugs or how long they can be used or even ordering one or more off the market.

The evidence is suggestive that there is something going on with each of these drugs, but it is not conclusive, commented Thomas Fleming, chairman of the department of biostatistics at the University of Washington.

Dr. Steven Abramson, chairman of the division of rheumatology at the New York University School of Medicine, said it's possible the problems stem from the ability of these drugs to hamper the Cox-2 enzyme. But he also suggested a study to examine whether similar problems arise from other painkillers, such as ibuprofen.

Dr. Peter A. Gross, chairman of internal medicine at the Hackensack University Medical Center in New Jersey, worried that if the committee did conclude the heart problems were related to the Cox-2 action, patients would all switch to older drugs that can cause ulcers and bleeding problems.

Gaithersburg (Reuters) - Die wegen Gesundheitsrisiken in Schlagzeile geratenen Schmerzmittel der US-Pharmakonzerne Merck und Pfizer sind einer Expertenkommission der US-Gesundheitsbehörde FDA zufolge sicher genug, um in den USA verkauft werden zu können.

Die Einschätzung der FDA-Experten werteten die Anleger als Kaufempfehlung für Pharmatitel. Die Aktien von Pfizer zogen so um fast sieben Prozent an, während der Kurs der Merck-Papiere um mehr als zwölf Prozent sprang.

Mit einer knappen Mehrheit von 17 zu 15 Stimmen kam der Expertenausschuss nach eigenen Angaben am Freitag zu dem Ergebnis, dass das Merck-Medikament Vioxx trotz eines erhöhten Herzinfarkt- und Schlaganfall-Risikos mit einigen Beschränkungen verkauft werden kann. Unter anderem muss auf der Verpackung eine Warnung vor den Herz-Kreislaufrisiken aufgedruckt sein. Merck wollte sich zunächst nicht dazu äußern, ob und wann der Konzern das populäre Arthritis-Medikament wieder an den Markt bringen will.

Merck hatte sein zur Klasse der Cox-2-Hemmer zählendes Medikament Vioxx Ende September weltweit vom Markt genommen, nachdem eine Krebsstudie ein erhöhtes Herz- und Schlaganfall-Risiko bei Patienten aufzeigte, die das Mittel mindestens 18 Monate einnehmen.

Die Experten der Gesundheitsbehörde sahen auch nicht notwendig, dass die Schmerzmittel Celebrax und Bextra von Pfizer vom Markt genommen wird. Sie kamen zu dem Ergebnis, dass auch diese Medikamente ausreichen sicher seien.

Vioxx, Celebrex und Bextra gehören zu den zuletzt stark in die Kritik geratenen zur Klasse der so genannten Cox-2-Hemmer. Diese waren in Studien mit einem erhöhten Herzinfarkt-Risiko in Verbindung gebracht worden. Cox-2-Hemmer - auch Coxibe genannt - sollten Schmerzen etwa bei Arthritis-Patienten so stark lindern wie ältere, nicht-verschreibungspflichtige Medikamente. Cox-2-Hemmer sind dabei aber magenfreundlicher als die älteren nicht-steroidalen Entzündungshemmer, zu denen etwa Ibuprofen und Naproxen gehören.

Die Gesundheitsbehörde wird Analysten zufolge ihre Entscheidung über die genannten Schmerzmittel in einigen Wochen treffen. Sie folgt normalerweise der Empfehlung der Expertenkommission.

The panel's recommendations backed the pharmaceutical industry's stance that no medicine is risk-free and that patients should sometimes be allowed to choose medicines that have serious risks even for conditions that are not life-threatening.

The panel, which was convened by the Food and Drug Administration to discuss the risks of pain medications, reached its conclusions after three days of hearings in Maryland. The F.D.A. typically adopts the recommendations of its expert panels, particularly in such controversial matters.

Even as a vocal alliance of consumer groups and plaintiffs' lawyers are raising similar questions over other widely used drugs, the panel's analysis offers at least a small dose of good news for the industry. Indeed, drug stocks rallied broadly yesterday, while the industry's critics spoke out against the panel's decision.

Merck shares ended the day up 13 percent, or $3.76, at $32.61. Pfizer rose almost 7 percent, gaining $1.74, to $26.80. Shares in both companies remain sharply lower than they were before Merck withdrew Vioxx from the market in late September.

Now Merck, which makes Vioxx, and Pfizer, which makes Celebrex and Bextra, face their own choices.

Merck stopped selling Vioxx last fall after a clinical trial showed evidence of heart risks in patients who took the drug for more than 18 months. The company can now decide whether to reintroduce it.

A Merck official said in testimony to the panel on Thursday that the company might take that step, if the experts concluded that the risks were characteristic of the entire class of drugs, known as cox-2 inhibitors. Yesterday, after the F.D.A. panel reached just that conclusion, Merck declined to comment further on its plans.

If it does bring back Vioxx, Merck faces the challenge of persuading doctors and their patients to use a medicine that it has already said is unsafe. Pfizer faces a similar though somewhat less serious challenge with its drugs, which have remained on the market, although their sales have fallen sharply.

Merck and Pfizer will also undoubtedly use the panel's conclusions to defend themselves against lawsuits by people who say they had heart problems after taking the drugs. Merck, in particular, faces hundreds of such suits, some of them scheduled to go to trial this spring.

While some lawyers said yesterday that jurors might not be swayed by the F.D.A. panel's analysis, the gains in Merck and Pfizer shares indicated that investors had initially concluded that the F.D.A. recommendations could limit the legal liabilities of the companies.

"Merck can say a panel of experts said this drug was safe enough to be continued to market," said C. J. Sylvester, an analyst at Banc of America Securities who has a neutral rating on the company.

John LaMattina, Pfizer's president for global research and development, said the panel's hearing had given patients new information about the risks and benefits of all pain medications, including over-the-counter drugs like Advil.

A spokeswoman for Merck said the company appreciated the chance to offer data to the committee and looked forward to further discussions with the F.D.A.

Despite yesterday's decision, the drugs will probably never again reach the sales they had last year, analysts said, in part because the panel recommended that the drugs carry so-called black box warnings - the most stringent measure used to warn of potential dangers.

Since they were introduced in 1999, Vioxx and Celebrex have been among the most heavily promoted and most popular drugs, each taken by more than 20 million people. In 2004, Vioxx, Celebrex and Bextra had combined sales of more than $6 billion, almost 10 percent of the total sales of Pfizer and Merck.

The recommendation that the drugs could still be sold drew scorn from critics like Dr. Marcia Angell, the former editor of The New England Journal of Medicine. She said the panel seemed to have been overly influenced by arthritis patients who testified that the drugs were the only medicines that helped them.

Dr. Angell said that Vioxx, Celebrex and Bextra had never been shown to work any better than older pain and arthritis medicines, so their increased heart risk make them unacceptable.

"I don't think any of these drugs should be on the market," Dr. Angell said. "To accept a risk like that you ought to have a powerful benefit, and I just don't see it. Anecdotes won't do it. Testimonials won't do it."

For Pfizer, the decision removes the risk that the company could be forced to withdraw Celebrex and Bextra from the market, which could have very likely spurred a flood of lawsuits similar to those that followed Vioxx's withdrawal last fall.

The legal picture is more complex for Merck, lawyers said yesterday. The company has set aside $675 million to cover the costs of fighting the lawsuits, and analysts have estimated its potential liabilities at $5 billion to $30 billion.

But the panel's decision yesterday gave Merck new ammunition for its claim that the benefits of the drug outweigh its risks, and plaintiffs' lawyers expect Merck to try to make the most of that in court.

"I'm sure Merck will try to use this to say the F.D.A. has reaffirmed that Vioxx is safe and effective," said Andy D. Birchfield Jr., a Montgomery, Ala., lawyer who began filing Vioxx lawsuits in 2001.

Some defense lawyers said that the panel's conclusions would not necessarily benefit Merck, even if the company did sell Vioxx again. Judges and juries may prefer to focus on the company's actions before it withdrew the drug in September.

"What Merck knew or should have known about the dangers and what it communicated at the time the product was taken is what's critical in these cases," said Kevin Dunn, a lawyer from San Francisco with many drug industry clients but no involvement with Merck.

Mr. Dunn added that the critical question was not whether adequate warnings were communicated to patients in advertising but whether doctors prescribing Vioxx had been fully informed.

Theodore V. H. Mayer, a lawyer for Merck, said simply, "It's too soon to speculate about the legal impact."

Merck has argued that it did not have conclusive evidence linking Vioxx to heightened heart attack and stroke risks until shortly before it withdrew the drug. Plaintiffs have said that clinical studies completed many years earlier provided ample evidence of the risks.

netti:
Ich habe mit keiner Silbe behauptet, PFIZER sei KEIN Langfristinvestment.
Solch große Schlachtrösser wie PFIZER eins ist, sind es meistens schon
von der Natur her.
Ich habe einzig und alleine bei Anti kritisiert, daß er seine Ampeln ohne
Gelbphase auf Grün schaltet.
Gerade wenn ich eine Aktie als Langsfristinvestment empfehle, spielt es
doch keine Rolle, ob ich noch drei Wochen zuwarte.

Anti:
Nicht daß ich Deinen Standpunkt als solchen kritisieren möchte. Im Prinzip
dürfte er richtig sein. Und Dir kommt auch das Verdienst einer Reihe von
interessanten und zutreffenden Analysen in diesem Thread zu. Hätte ich
nicht schon selbst hier gepostet, hättest Du schon mehr als einen Grünen
von mir gekriegt.
Aber was mich etwas mißtrauisch macht, ist Deine Euphorie. Die erinnert
mich irgendwie an den Sommer vergangenen Jahres. Auch da warst Du eu-
phorisch, nur um Dich hinterher mehr oder weniger verbittert zurückzu-
ziehen. Wärst Du damals nicht so euphorisch gewesen, wär Dir das erspart
geblieben und Du wärst heute noch dabei (ich bin's übrigens wieder - mit
Gewinn).
Ich denke, Du verstehst, wie ich das meine.