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Alt 01-11-2004, 15:32   #46
crazy_coco
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Merck (MRK) shares sagged 6% to a new eight-year low ahead of the open after The Wall Street Journal unearthed emails suggesting the drug maker knew a lot more than it let on about Vioxx's heart risks



Merck tried to bury Vioxx concerns for years - WSJ
Mon Nov 1, 2004 06:23 AM ET
NEW YORK, Nov 1 (Reuters) - Internal e-mails and other documents from Merck & Co. (MRK.N: Quote, Profile, Research) show the company fought for years to keep safety concerns from undermining the drug's commercial prospects, the Wall Street Journal reported on Monday.

Vioxx, a drug known as a COX-2 inhibitor, was withdrawn from the market after it was shown to double the risk of heart attack and stroke in patients who had been taking it for at least 18 months. Vioxx generated some $2.5 billion in annual sales, and its withdrawal pummeled Merck's shares.

On Monday, the Journal reported that an e-mail dated March 9, 2000, suggested Merck recognized that something in Vioxx was linked to increased heart risk.

Edward Scolnick, Merck research chief at the time, wrote in the e-mail that cardiovascular events "are clearly there" and called it a "shame."

Although Scolnick compared Vioxx with other drugs with known side effects and wrote, "there is always a hazard," the company's public statements continued to reject the link between Vioxx and increased intrinsic risk.

Ted Mayer, a lawyer representing Merck, told the journal that the e-mails and marketing materials were "taken out of context" and "do not accurately represent the conduct of Merck and its employees."

But a memorandum dated Nov. 21, 1996, by a Merck official illustrated that the company wrestled with Vioxx's potential to induce a cardiac event, the report said. Another e-mail highlighted the possibility that patients could suffer blood clots unless they were also given aspirin.

Those documents may be used in ongoing litigation against the company.

On Friday, Merck -- citing documents that had been made public -- issued a statement saying that it acted "responsibly and appropriately" in developing and marketing Vioxx.

It was not immediately clear if it was referring to those obtained by the Journal, and a company representative was not immediately available to comment early Monday.
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Alt 01-11-2004, 20:50   #47
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Pharma
Merck kannte Vioxx-Risiken angeblich seit Jahren



http://www.faz.net/aktuell/wirtschaf...n-1193804.html
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Alt 01-11-2004, 22:27   #48
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Alt 02-11-2004, 20:14   #49
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Das Märchen von interner E-Mail sorgt offensichtlich auch heute weiter für fallende Kurse. Die Axxie steht in NY gerade bei 27.06 USD und die Dividendenrendite steigt damit auf 5,61%. Die Rendite von Bayer war damals während der Lipobay-Story aber bei mind. 8% (wenn nicht 11%?). Andererseits sind wir aber nicht im Krieg, warten wir es also weiter ab.
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Alt 05-11-2004, 17:41   #50
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FDA drug monitoring system probed

By Laura Gilcrest, CBS MarketWatch
Last Update: 11:58 AM ET Nov. 5, 2004


WASHINGTON (CBS.MW)-- The U.S Food and Drug Administration said on Friday that it has asked the Institute of Medicine to review how FDA monitors drugs after they hit the market.


IOM, an arm of the National Academies of Science, will assess what steps can be taken to learn more about drugs' side effects once they're being prescribed to patients, then give advice for enhancing public confidence in drugs' safety and effectiveness.

FDA's request for the IOM study is part of a broader plan to shore up the nation's post-market drug monitoring system in the wake of the recent market withdrawal of Merck's (MRK: news, chart, profile) arthritis drug Vioxx.

FDA reviews a drug's clinical data on safety and effectiveness to decide whether to grant market approval, but continues to scrutinize the drug's safety once it's on the market.

The agency gets post-market data via additional clinal studies and through adverse events reports submitted through FDA's MedWatch program.

But managing a drug's risks and benefits is no easy task, said Acting FDA Commissioner Lester Crawford. "FDA is determined to meet this challenge by employing cutting edge science, transparent policy, and sound decisions based on the advice of the best experts in and out of the agency," he said in a statement issued on Friday.

Crawford said FDA would also set up a program to resolve conflicting opinions among its drug reviewers about a particular drug's approvability.

In most cases, FDA's medical reviews reach agreement, he said, adding that, "Sometimes, however, a consensus decision cannot be reached and an employee may feel that his or her opinion was not adequately considered."

Under the plan, an ad hoc panel not directly involved in internal disputes will have 30 days to review relevant data and recommend a course of action.

FDA said it would also work to fill the vacant position of director of its Office of Drug Safety, hold workshops and advisory panel meetings on drug risk management issues, and release by year's end, three final guides to help drug firms manage product risks.

Quelle
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Alt 05-11-2004, 17:49   #51
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Vioxx Recall Dogs Merck

Zitat:
By TSC Staff
11/5/2004 9:29 AM EST

Merck (MRK:NYSE - commentary - research) shares were unchanged early Friday after the latest development in the Vioxx recall saga.

The drugmaker early today said it had posted a scientific critique on its Web site to "further clarify for the scientific community why Merck disagrees with the conclusions" of an article published in this week's issue of The Lancet, the British medical journal.

In a brief statement, Merck reiterated its disagreement with the methodology used. The British medical journal reported there was sufficient evidence of the dangerous side effects of the drug by the end of 2000, but the data was not analyzed properly.

Questions about Merck's handling of safety issues surrounding Vioxx and the related risk of heart attacks prior to its eventual recall in September continue to dog the drugmaker, further devaluing its already-beaten-down stock. Merck has repeatedly said it made the recall at the right time, based on the best information available at the time.

The Vioxx recall has raised new questions about the tenure of Merck Chairman and CEO Raymond Gilmartin, who is not scheduled to retire until 2006. Gilmartin's reign has been marked by a series of stumbles in the last couple years, culminating in the recall of Vioxx, its No. 2 drug.

Merck shares were down 2 cents to $27, having touched an eight-year low earlier this week. The stock closed at $45.07 on Sept. 29, the day before the company said it was pulling Vioxx from the market.
Quelle:

Mein Kommentar: Die Informationen von Merck sind wahrscheinlich hier zu finden. Aber sie interessieren momentan an der Börse keinen. Mich würde sehr interessieren:
1. ob die Fondsmanager nur so naiv sind, oder
2. ob der Wert gezielt leerverkauft wird.

In dem ersten Fall geht es bis zur ersten gewonnenen Verhandlung sicher runter, aber im zweiten könnte ein Turnaround früher kommen, denn dann spielen Nachrichten eine untergeordnete Rolle.

@Alle:

kann man irgendwo die Leerverkäufe für Merck sehen? Wäre sehr dankbar für diese Info!
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Alt 09-11-2004, 13:53   #52
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Post Merck Faces Twin Vioxx Inquiries

By SCOTT HENSLEY
Staff Reporter of THE WALL STREET JOURNAL
November 9, 2004;

Merck & Co. said the Justice Department has launched a criminal investigation into the company's handling of Vioxx, the painkiller that the drug maker withdrew in September, and the Securities and Exchange Commission has begun an informal inquiry.

Merck, which made the disclosure in a quarterly regulatory filing, said it is cooperating with both investigations.

The pharmaceuticals giant warned in the filing that it couldn't predict how the investigations would turn out, but said their conclusions could be "highly unfavorable" and include dispositions that "could have a material adverse effect on the Company's financial position, liquidity and results of operations."

The disclosure came yesterday after the stock market closed and is the latest sign of the deepening crisis over Vioxx. The company pulled the popular arthritis medicine from the market after finding the drug increased the risk of heart attacks and strokes in patients who took it for more than 18 months.


In a written response to questions about the investigations, Merck said "it acted responsibly and appropriately as it developed and marketed Vioxx." A week after learning of the results of a company-sponsored clinical trial demonstrating Vioxx's risks, Merck said it "acted in what it believed was the best interest of patients and voluntarily withdrew Vioxx from the market."

Merck, of Whitehouse Station, N.J., said the Justice Department subpoenaed information related to the company's research, marketing and selling activities for Vioxx. A Justice Department spokesman had no comment.

The SEC's focus is likely to be on issues of disclosure, such as whether Merck fully informed investors about the information that emerged from research about Vioxx's risks. An SEC spokesman declined to comment.

Merck yesterday also quantified the litigation it faces. As of Oct. 31, the drug maker said it was a defendant in about 375 Vioxx personal-injury lawsuits, involving about 1,000 plaintiff groups. One or more of those cases may go to trial in the first half of 2005, the company said.

Citing "media reports and other sources," Merck said it expects more lawsuits will be filed against the company and possibly its current and former officers and directors.

The company said it had at least $190 million in insurance to cover its directors and officers and to cover lawsuits related to securities law.

As for product liability, Merck said it has about $630 million in insurance coverage. That amount could fall far short of potential damage awards, according to recent estimates from some Wall Street analysts. In its filing, Merck said it is "unable at this time to determine" whether its insurance coverage "will be adequate to cover its defense costs and losses, if any," in relation to Vioxx.

"The endgame of an SEC investigation or criminal probe pales in comparison to what they face in terms of product liability," said Richard Evans, a drug industry analyst with Sanford Bernstein in New York who estimates that Merck's potential product liability is "$12 billion and climbing." The greatest danger of the Justice Department's probe may be that its "more aggressive and complete discovery process" could ease the burden of proof for plaintiffs' lawyers to show negligence or to win punitive damages.

Even so, proving that any particular patient died or was injured by Vioxx could be difficult.

The 2,600-patient study that led Merck to pull Vioxx gave patients either a 25 milligram dose of the drug daily or a sugar pill. Based on a preliminary analysis, there were 45 confirmed cardiovascular events, such as heart attacks or strokes, among the patients taking Vioxx compared with 25 events among those on the placebos. The risk emerged only after 18 months of treatment and no difference in overall mortality was observed between the groups.

Mr. Evans, in a report last month, acknowledged the heavy burden on plaintiffs to show that Vioxx and not nature caused their specific injuries.

Merck declined to comment on financial analysts' estimates of potential liability.

The Wall Street Journal reported last week about Merck documents and e-mails that raised the possibility the company may have known more about the risks of Vioxx than previously acknowledged.

A lawyer representing Merck said the internal e-mails and marketing materials were "taken out of context" and "do not accurately represent the conduct of Merck and its employees." Merck didn't provide other documents to furnish context, citing continuing litigation.

Merck stock, which traded at around $45 before the Vioxx fiasco, fell 2.5% to $25.91 in after-hours trading yesterday.

Quelle: Wall Street Journal
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Alt 09-11-2004, 14:00   #53
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Merck Falls on Word of Federal Probes Over Vioxx

By Robert Steyer
TheStreet.com Staff Reporter
11/9/2004 8:16 AM EST
Updated from Nov. 8

Merck (MRK:NYSE - commentary - research) shares were near their 52-week intraday low in early trading Tuesday after the company late Monday revealed that it is the subject of a criminal investigation by the Justice Department concerning events leading up to the removal of the arthritis drug Vioxx from the market on Sept. 30.

In addition, Merck said that it is the subject of an "informal inquiry" about Vioxx by the Securities and Exchange Commission.

In premarket trading, the stock was off 76 cents, or 2.9%, to $25.81.

The company revealed the developments in a quarterly filing with the SEC after markets had closed on Monday. Merck previously said it was removing the arthritis drug from the market because tests showed long-term use of Vioxx -- more than 18 months -- showed a greater cardiovascular risk among Vioxx patients than among people who took a placebo.

Merck said Monday that it had received a subpoena from the Justice Department relating to the "research, marketing and selling activities" in an investigation "under criminal statutes."

Merck, which provided few details in its quarterly filing, said it was told by the SEC staff that the commission was beginning an informal inquiry.

Merck said it would cooperate with the Justice Department and the SEC.

"The company cannot predict the outcome of these inquiries," Merck said. "However, it is possible that highly unfavorable outcomes, including a potential civil disposition from the SEC and/or potential civil or criminal dispositions from the Justice Department, could have a material adverse effect on the company's financial position, liquidity and results of operations."

Merck's potential legal bill for Vioxx is getting as much, if not more, attention on Wall Street than its products and its research efforts.

Standard & Poor's said recently that it was putting Merck's corporate credit and unsecured debt ratings on its CreditWatch list "with negative implications," thus placing Merck's AAA credit rating in jeopardy, because of increasing concern about the "magnitude of possible litigation" due to Vioxx.
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Alt 09-11-2004, 14:05   #54
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Merck/Schering-Plough Pharmaceuticals Announces New Clinical Trial for VYTORIN

Press Release Source: Merck & Co., Inc.

Merck/Schering-Plough Pharmaceuticals Announces New Clinical Trial for VYTORIN -ezetimibe/simvastatin-

Tuesday November 9, 8:38 am ET

Nov. 9, 2004--

Large Trial to Evaluate VYTORIN(TM) in Reducing Major Cardiovascular Events Through Intensive Lowering of LDL Cholesterol in Patients with Acute Coronary Syndromes

Merck/Schering-Plough Pharmaceuticals today announced a large scale clinical outcomes trial that will be conducted for VYTORIN(TM) (ezetimibe/simvastatin). The trial known as IMPROVE IT (Improved Reduction of Outcomes: VYTORIN Efficacy International Trial) will evaluate the risk reduction provided by VYTORIN 10/40 mg as compared to Zocor (simvastatin) 40 mg in reducing death and major coronary events in approximately 10,000 patients with acute coronary syndromes (ACS). In clinical trials, VYTORIN has been shown to provide superior LDL cholesterol lowering as compared to Lipitor or Zocor. The intent of the study is to determine whether VYTORIN provides incremental reductions in cardiovascular events in these patients as compared to simvastatin. The primary endpoint of the trial is the composite of death, myocardial infarction (MI), rehospitalization for ACS or revascularization (occurring 30 days or more after the initial event).

"The purpose of IMPROVE IT is to evaluate the potential incremental impact of VYTORIN versus simvastatin alone in reducing mortality and morbidity in high risk patients with ACS by dramatically lowering LDL cholesterol through dual inhibition," said Eugene Braunwald, M.D., F.A.C.C., Distinguished Hersey Professor of Medicine, Harvard Medical School, chairman TIMI Study Group, Brigham and Women's Hospital.

Study Design

IMPROVE IT is a multi-center, randomized, double-blind active comparator study that will enroll approximately 10,000 patients with ACS, including unstable angina (UA), non-ST-segment elevation acute myocardial infarction (NSTEMI) and ST-segment elevation acute myocardial infarction (STEMI). Patients will be randomized to either VYTORIN 10/40 mg or simvastatin 40 mg per day. Patients will be followed for over two years.

"There is growing clinical evidence that intensive lipid lowering provides additional benefits to high-risk patients. IMPROVE IT will potentially provide further clinical evidence on how best to manage high-risk patients with ACS. It will also further characterize the clinical profile of VYTORIN beyond its already demonstrated significant efficacy in LDL cholesterol reduction," said Robert M. Califf, M.D., F.A.C.C., professor of medicine, director, Duke Clinical Research Institute, Duke University Medical Center.

About Acute Coronary Syndromes

ACS includes unstable angina (UA), non ST-elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI) patients. ACS is usually caused by the buildup of plaque (deposits of fat-like substances) in the coronary arteries of the heart. These plaques may tear or rupture, leading to the formation of a blood clot which may partly or completely block the blood flow in a coronary artery, abruptly limiting the supply of oxygenated blood to a portion of heart muscle. Patients with UA often experience severe constricting pain in the chest occurring at rest, but testing does not show evidence of heart muscle damage. However, the development of UA is a warning sign that a heart attack may soon occur. NSTEMI, the most common form of heart attack, presents similarly to UA but is accompanied by evidence of heart muscle damage. In STEMI, an abrupt complete blockage of the coronary artery causes more extensive damage to the heart muscle. The treatment of ACS includes improving blood supply to the heart muscle, preventing further clot formation, and, ultimately, preventing further progression of coronary atherosclerosis. According to the American Heart Association, it is estimated that approximately 1.5 million patients are annually admitted for symptoms of ACS in the United States alone.

Full indications and contraindication for VYTORIN

VYTORIN is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, Apo B(1), triglycerides and non-HDL cholesterol and to increase HDL cholesterol in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidemia. VYTORIN also is indicated for the reduction of elevated total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.

VYTORIN is a prescription medicine and should not be taken by people who are hypersensitive to any of its components. VYTORIN should not be taken by anyone with active liver disease or unexplained persistent elevations of serum transaminases. Women who are of childbearing age (unless highly unlikely to conceive), are nursing or who are pregnant should not take VYTORIN.

Selected cautionary information for VYTORIN

Muscle pain, tenderness or weakness in people taking VYTORIN should be reported to a doctor promptly because these could be signs of a serious side effect. VYTORIN should be discontinued if myopathy is diagnosed or suspected. To help avoid serious side effects, patients should talk to their doctor about medicine or food they should avoid while taking VYTORIN. In three placebo-controlled, 12-week trials, the incidence of consecutive elevations (Greater than 3 X ULN) in serum transaminases were 1.7 percent overall for patients treated with VYTORIN and 2.6 percent for patients treated with VYTORIN 10/80 mg. In controlled long-term (48 week) extensions, which included both newly-treated and previously-treated patients, the incidence of consecutive elevations (Greater than 3 X ULN) in serum transaminases was 1.8 percent overall and 3.6 percent for patients treated with VYTORIN 10/80 mg. These elevations in transaminases were generally asymptomatic, not associated with cholestasis and returned to baseline after discontinuation of therapy or with continued treatment. Doctors should perform blood tests before, and periodically during treatment with VYTORIN when clinically indicated to check for liver problems. People taking VYTORIN 10/80 mg should receive an additional liver function test prior to and three months after titration and periodically during the first year.

Due to the unknown effects of increased exposure to ezetimibe (an ingredient in VYTORIN) in patients with moderate or severe hepatic insufficiency, VYTORIN is not recommended in these patients. The safety and effectiveness of VYTORIN with fibrates have not been established; therefore, co-administration with fibrates is not recommended. Caution should be exercised when initiating VYTORIN in patients treated with cyclosporine and in patients with severe renal insufficiency.

In clinical studies VYTORIN was well tolerated with a low incidence of adverse events

VYTORIN has been evaluated for safety in more than 3,800 patients in clinical trials and was generally well tolerated at all doses (10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg). In clinical trials, the most commonly reported side effects, regardless of cause, included headache (6.8 percent), upper respiratory tract infection (3.9 percent), myalgia (3.5 percent), influenza (2.6 percent) and extremity pain (2.3 percent).

Additional Outcomes Trials for VYTORIN

In addition to the IMPROVE-IT trial, Merck/Schering-Plough Pharmaceuticals is conducting three other large-scale clinical outcomes trials. They are:

The trial known as SHARP (Study of Heart And Renal Protection) will evaluate the effects of lowering LDL-C with ZETIA 10 mg and simvastatin 20 mg daily versus placebo in 9,000 patients with chronic kidney disease. The study will assess the effect of this combination therapy on the time to the first major vascular event (i.e., heart attack, stroke, or revascularization) and on progression to end-stage renal disease among pre-dialysis patients, as well as assessing safety and tolerability in the different treatment arms.

The trial known as SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) is a placebo controlled study that will examine the reduction in mortality and morbidity of patients with aortic stenosis with the co-administration of ZETIA and simvastatin 40 mg.

The trial known as ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) will evaluate ZETIA 10 mg and simvastatin 80 mg versus simvastatin 80 mg alone in reversing the atherosclerotic thickening of the carotid artery in patients with high cholesterol.
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Alt 09-11-2004, 14:06   #55
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MRK 8:58AM ET 25.87 -0.70 (-2.63%)


kurze deutsche Übersetzung

Merck & Co. im Visier von Ermittlungen


Der Pharmakonzern Merck & Co. sieht sich im Zusammenhang mit dem Rückruf des Arthritis-und Schmerzmittels Vioxx mit Ermittlungen durch das US-Justizministerium konfrontiert. Wie Merck & Co am Montag nach Börsenschluss mitteilte, sind für Anfang Dezember Unternehmensvertreter behördlich geladen. Die Untersuchung würde sich auf bundesstrafgerichtliche Belange erstrecken. Zudem hat die Börsenaufsichtsbehörde SEC eine Untersuchung gegen Merck & Co hinsichtlich der Rechtmäßigkeit der Vorgehensweise des Unternehmens bei Vioxx eingeleitet. Merck hat zugleich betont, dass jene Verfahren geeignet seien negativen Auswirkungen auf die Finanzsituation, Liquidität und den operativen Bereich nach sich zu ziehen.

Merck geben vorbörslich an der NYSE um rund 3% auf 25,80 USD nach

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Geändert von crazy_coco (09-11-2004 um 14:11 Uhr)
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Alt 10-11-2004, 13:11   #56
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Merck & Co von Moody`s herabgestuft


https://www.boerse-go.de/nachricht/m...7,a114522.html


MRK 8:04AM ET 25.76 -0.24 (-0.92%)
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Alt 15-11-2004, 13:33   #57
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Merck: 2 Studien zeigten Vioxx-Gefahren


https://www.boerse-go.de/nachricht/m...7,a114538.html
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Alt 18-11-2004, 13:06   #58
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NYT: Vioxx-Problematik war Merck lange bekannt


https://www.boerse-go.de/nachricht/n...7,a114554.html


MRK 8:03AM ET 27.25 -0.09 (-0.33%)
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Alt 18-11-2004, 20:26   #59
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Congress Told FDA Failed Public on Vioxx

Reuters

Thursday November 18, 2:37 pm ET
By Lisa Richwine

WASHINGTON (Reuters) - The U.S. Food and Drug Administration failed the public in its oversight of Merck & Co Inc.'s (NYSE:MRK - News) withdrawn painkiller Vioxx and is "incapable of protecting America" from another dangerous drug, an agency researcher told Congress on Thursday.

David Graham, an FDA scientist who had warned about the heart risks of Vioxx, called the FDA's actions "a profound regulatory failure."

Concerns about a possible link between Vioxx and heart problems were building during the drug's more than four years on the market. The FDA required a warning about heart risks but felt the drug's benefits made it worth keeping on the market.

Merck Chief Executive Raymond Gilmartin said the company had believed wholeheartedly in Vioxx and had followed a rigorous scientific procedure every step of the way.

"In fact, my wife was taking Vioxx, using Vioxx, up until the day we withdrew it from the market," Gilmartin told the Senate Finance Committee.

Merck withdrew Vioxx, which was taken by millions of Americans, on Sept. 30 after a study showed the drug doubled heart attack and stroke risk.

"I would argue the FDA as currently configured is incapable of protecting America against another Vioxx. We are virtually defenseless," said Graham, associate director for science in the FDA's Office of Drug Safety.

Committee Chairman Charles Grassley, an Iowa Republican, said he was concerned the FDA had a "far too cozy" relationship with drug companies and suggested an independent office of drug safety might be needed.

Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, said the agency "worked actively and vigorously with Merck to inform public health professionals of what was known regarding (cardiovascular risk) with Vioxx and to pursue further definitive investigations."

Kweder also declined to fault Merck: "I believe that Merck acted responsibly once the problem was recognized."

Graham told the committee he felt pressured by supervisors to water down his findings from a study of patient insurance records that Vioxx users had a 50 percent greater chance of heart attack and sudden cardiac death than people who took Pfizer Inc.'s (NYSE:PFE - News) rival medicine Celebrex.

Graham named five medicines currently on the market that he believes need closer scrutiny for safety: Abbott Laboratories Inc.'s (NYSE:ABT - News) weight-loss drug Meridia, AstraZeneca Plc's (London:AZN.L - News) cholesterol-lowering drug Crestor, Pfizer Inc.'s (NYSE:PFE - News) painkiller Bextra, Roche's (ROG.VX) acne drug Accutane, and GlaxoSmithKline Plc's (London:GSK.L - News) asthma drug Serevent.

Kweder disagreed. "I do not have reason to believe that set of five drugs is specifically more concerning," she said.

In a statement on Wednesday, acting FDA Commissioner Lester Crawford said Graham had violated long-standing procedures for publishing scientific findings when he submitted his research to a medical journal without FDA clearance.

Grassley said Crawford's statement appeared intended to intimidate a witness on the eve of a hearing.

Sen. Orrin Hatch, a Utah Republican, urged fellow senators to keep an open mind, saying, "Today some are trying to punish one drug company for acting appropriately within the framework of our regulatory system."

But Grassley said Vioxx was the second example this year of the FDA not respecting its own scientists. Another FDA reviewer, Dr. Andrew Mosholder, had warned that antidepressants were linked to suicidal behavior in pediatric patients, but supervisors initially kept him from making those views public.

"Now we have scientists in this particular (Vioxx) case who are being harassed within the agency because of sticking to their own science," Grassley said.

He also faulted Merck for aggressively marketing Vioxx for nearly two years between submitting results of a trial to the FDA in June of 2000 showing a higher incidence of cardiac problems with Vioxx, and the FDA approving a new label detailing those risks in April 2002.

Merck's Gilmartin insisted the company had acted properly with Vioxx. "Over the past six years, we have promptly disclosed results of numerous Merck-sponsored studies to the FDA, physicians, the scientific community and the media," he said. (Additional reporting by Susan Heavey, Susan Cornwell and Tim Dobbyn, editing by John Wallace; Reuters Messaging: lisa.richwine.reuters.com Klammeraffe reuters.net; Tel: 202 310-5691))
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Alt 24-11-2004, 20:06   #60
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Merck Maintains Quarterly Dividend

Wednesday November 24, 7:40 am ET

NEW YORK (Reuters) - Merck & Co. Inc. (NYSE:MRK - News) has declared its regular quarterly dividend, maintaining its status as one of the richest dividend payors among blue-chip stocks, even following the withdrawal of its arthritis drug Vioxx and subsequent loss of nearly $27 billion in market value.

In a statement after the market closed on Tuesday, the company declared a quarterly dividend of 38 cents a share for the first quarter of 2005, payable on Jan. 3 to stockholders of record on Dec. 3, 2004.

The payout represents a 5.6 percent yield based on Merck's closing price Tuesday of $27.15 a share and is the second-highest among the 30 stocks in the Dow Jones industrial average. The only Dow component with a higher yield is Microsoft Corp., but its 11.6 percent yield is skewed by its recent one-time $3 a share dividend.

Merck said at the time of the withrawal of Vioxx in late September that it would not change its dividend.
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