Saturday, February 19, 2005

VIOXX,corrupt Big Pharma, FDA, Australian DOH

My notes: A lot of people put a lot of faith in Pharmaceutical companies and Biotech companies. Just yesterday someone in a forum implied to me that science and medicines were not “business” and that scientists could be trusted completely. These articles if read will make you understand the complexity of these issues. Last year, Dr. David Graham, a MD and an investigator for the FDA, the US Food and Drug “watchdog” for the public safety, blew the whistle on a drug made by Merck called VIOXX saying it had a 40% death rate from sudden cardiac collapse. Lawsuits started happening. The Merck used the FDA again to form a “panel” [of whom at least some of the "experts" work for the FDA] to give the ok to people being informed the drug may be deadly and allowing them to “choose” it away. That helps Merck because then they can produce this most likely paid for under the table panel of “experts” as testimony for Merck to defend themselves in their class action lawsuits. Twenty million people were taking VIOXX. Isn’t it also odd how suddenly like a bolt out of the blue, the US Congress decided to change the laws on class action laws suits this past week? I just find that to be a remarkable “coincidence”, don’t you? Merck if sued by all twenty million for giving them drugs now proved to damage the heart muscle leading to sudden death, would be put out of business, but Congress, the best Congress money can buy, stepped to save the day for the BIG PHARMA, but not for the US public taxpayers who pay their salaries and provide them with extraordinary perqs and lifetime benefits. Also, the big newspapers, like the NY Times started running articles ‘warning’ the public that all drugs have risk and if they bear the risk, then oh well. If this whole mess does not convince anyone that BIG PHARMA is bad business and not safe for humans then those who will not see the truth, deserve what they get. Several articles included with all quotes and all given their due acknowledgement as a Public Health Service to alert the public.

From the NY Times:
A Reminder That No Drug Is Risk-Free

Published: February 19, 2005

Cost-benefit analyses for drugs are rarely as explicit as they were yesterday.

When a federal panel of doctors and scientists recommended allowing the sale of arthritis medicines from Pfizer and Merck despite acknowledging their heart risks, it did more than just give new life for Celebrex, Bextra and possibly Vioxx - three drugs some analysts had viewed as doomed.

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.
[end quote]

From FierceHealthCare’s Editor Matthew Holt:
Feb 19,2005:

This has been a momentous week for the FDA, the Cox-2 painkillers and the future of prescription drugs. We now have a new FDA head, a new Drug Safety Board within the FDA, and Pfizer and Merck pondering whether there is a future for Celebrex and Vioxx. While Merck muses about putting Vioxx back on the market, my sources tell me that the going rate for the Keyword "Vioxx" on Google has been bid up to $100 a click by trial lawyers keen to get more people into their class action suits. It all seems as though there will be a lot more caution in future on the approval of any new drug and a lot less indecision about the new FDA removing potentially unsafe drugs from the market.

In the current regulatory and legal climate it might sound crazy that Vioxx be put back on the market. But the fact is that all drugs have some side-effects, and for the vast majority of people the Cox-2s work and don't cause problems. If a patient finds that a Cox-2 works for them, and they and their doctor are aware of the risks involved and are monitored for the adverse side effects, is it not reasonable for that therapy to be available to them? Maybe so. The key to all of this is for all of the information to be made available in an unbiased way so that doctors and patients can make informed choices.

For more comment from me, see The Health Care Blog. Please note that FierceHealthcare will not be published on Monday for the Presidents' Day holiday. We'll be back on Tuesday, February 22. - Matthew

[end quote]
Also from FierceHealthCare:
Feb 19,2005
1. FDA to vote on Cox-2s; Merck may consider Vioxx return

Merck made headlines across the country with its announcement yesterday that it might consider putting Vioxx back on the market if the FDA concludes the cardiovascular risks found to be associated with Vioxx are shared by other Cox-2 drugs like Celebrex and Bextra, as well as drugs considered "safe" like naproxen (Aleve) and Mobic. That surprising news came on a day dominated by stories about the Food and Drug Administration and the Cox-2 drugs. Today, the 30-member panel made up of FDA drug safety and arthritis experts voted to allow Celebrex to remain on the market and will decide the fate of the other drugs later in the day.

Yesterday, the FDA panel heard more evidence from experts both in favor of and against the painkillers, as well as testimony from patients who say their lives would be unbearable without the arthritis drugs, and even from a military doctor who warned "the Cox-2's are necessary for the war against terrorism," which incited laughter from the panel. It's likely that a class warning will be given to all Cox-2s, but unlikely that the panel will vote to take them off the market completely.

- see this story from The New York Times
- see this story from Forbes
- see this AP story for more on the Celebrex decision

[end quote]
Also from FierceHealthCare:
Feb 19,2005:

2. Graham, Europeans suspicious of Cox-2s

The focus of much attention yesterday -- at least until Merck's announcement -- was David Graham, the FDA scientist who made headlines late last year with his charges about the safety of Vioxx and other Cox-2 drugs. As expected, Graham had little nice to say about Celebrex and Vioxx. He testified that there is little reason for the drugs to be on the market when equally effective drugs are available, arguing there is a "class-effect" involving the drugs.

Meanwhile, regulators in Europe made their decision regarding the Cox-2 class yesterday, saying they will require warning labels on all Cox-2 drugs sold in the European Union. After meetings this week in London, the European Medicines Agency said that the cardiovascular risks associated with drugs like Vioxx, Celebrex and Bextra make a warning necessary.

- see this story on Graham's testimony from The Washington Post
- see this story from Forbes on the European Medicines Agency

[end quote]

From Matthew’s Editor’s Page on Feb 18,2005 in FierceBiotech:

Whatever the FDA expert panel decides on Cox-2 inhibitors this afternoon, the evidence is growing increasingly clear that the agency will have a long way to go to reassure the public that it is doing everything in its power to safeguard them from dangerous drugs. Dr. David Graham gave a chilling account of a 40 percent death rate from heart attacks triggered by Vioxx. Many of the patients taking these drugs never even needed them. And no one at the top echelon of the FDA bothered to warn them of the risks. Drug companies, too, need to understand that their credibility is growing thin. One expert commented that Pfizer's claim that no evidence linked Celebrex and Bextra to elevated risks of heart attacks was "beyond laughable." So is this entire situation with drug safety.

On a different note, the markets are closed Monday in observance of the Presidents' Day holiday here in the US, and so are we. FierceBiotech will return on Tuesday, February 22. Have a nice weekend! - John Carroll

in FierceHealthCare, Feb 17,2005:

1. FDA hearings on Cox-2s open; Graham testifies

The much-anticipated FDA hearings on the safety of the Cox-2 class began yesterday in Gaithersburg, Maryland, drawing national media attention. A joint panel of FDA officials specializing in drug safety heard leading drug safety experts testify about the wisdom of continuing to allow the controversial painkillers to remain on the market. As expected, much of the testimony was sharply critical of the way in which drug companies have handled the safety issues involved. Pfizer received probably the harshest treatment for its handling of Celebrex, drawing tough questions about the adequacy of the data it relied on in its clinical trials. When a Pfizer scientist said the company believes there is no evidence that its drug poses health risks, Dr. Alastair Wood of Vanderbilt said, "that doesn't even pass the laugh test."

Merck drew less attention, although the admission by the company's scientists that they accept there may be a "class effect" associated with the drugs created a stir. Today's testimony featured Dr. David Graham, the FDA researcher who crated controversy during Congressional hearings following the Vioxx withdrawal. Graham presented his own safety data on the drugs and thanked new FDA chief Lester Crawford for allowing him to present all his findings. He said that heart problems in the typical Vioxx user were more common than shown in the clinical trials and that it was a class effect that also applied to Celebrex. He was not sure if Bextra was also affected.

- see this story from The New York Times
- see this story from the Los Angeles Times
- see this story from Forbes
- see the AP story with details of Graham's testimony

2. Federal Judge consolidates Vioxx cases

The ongoing hearings have particular relevance, of course, for Merck, which faces a series of class-action lawsuits brought by people who say they suffered health problems as a result of taking the company's blockbuster painkiller Vioxx. Yesterday, a federal judge ordered the consolidation of hundreds of cases involving the drug into a single action which will be heard by a New Orleans court.

The decision is seen by some as an advantage for those filing suits against the company. It means the case will be handled by Judge Eldon Fallon, a former trial lawyer believed to be a more sympathetic figure than the other available choices. Fallon is currently overseeing a settlement in a class action suit held last year involving Propulsid, a heartburn drug linked to cardiac problems, which is manufactured by Janssen Pharmaceutica, a subsidiary of Johnson & Johnson.

- see this story from The New York Times

[end quote]

From The Medical News Today, Feb 18,2005:


Merck Issues Statement on Granting of Coordinated Pre-Trial Status For Federal VIOXX® Lawsuits
18 Feb 2005
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The federal Judicial Panel on Multidistrict Litigation today granted motions by several parties, including Merck, to transfer all VIOXX® product liability lawsuits pending in federal courts nationwide into one consolidated Multidistrict Litigation (MDL) for coordinated pre-trial proceedings.

The product liability cases, now designated as “MDL 1657-In re VIOXX Product Liability Litigation,” include all federal cases involving personal injury or economic losses arising from the use and/or purchases of VIOXX. Those cases are being transferred to the United States District Court in Eastern District for Louisiana before Federal District Judge Eldon E. Fallon.

The company is still awaiting a decision from the panel with respect to the shareholder suits, designated as “MDL 1658-In re Merck & Co., Inc., Securities, Derivative & ‘ERISA' Litigation.”

With respect to the product liability cases, designated as “MDL 1657-In re VIOXX Product Liability Litigation,” Judge Eldon E. Fallon will now set the schedule for pre-trial matters.

Merck intends to vigorously defend itself. Merck acted responsibly every step of the way - from researching the drug prior to approval - to monitoring the drug while it was on the market and - to voluntarily withdrawing the drug when it did. Merck based its decisions on the data from well controlled clinical trials and acted in the best interest of patients.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The company also devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit

Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2003, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference. [end quote]

From The Medical News Today, but is a Press Release from Australia Dept of Health for Doctors and Pharmacists {and Health care Providers} Note that the US Dept of Health has made NO statements on the safety or use of that drug to my knowledge:
Feb 19,2005

Expanded information on Cox-2 inhibitors for doctors and pharmacists, Australia
12 Feb 2005
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The Therapeutic Goods Administration (TGA) of Australia has introduced new measures on the prescribing of anti-arthritis drugs known as Cox-2 inhibitors following the findings of a review into the safety of this family of medicines.

In September last year the popular arthritis drug, Vioxx, was withdrawn from the market world wide because medical trials had shown a significant increased risk of heart attacks and strokes.

In response, the TGA undertook urgent evaluations of new information provided by the sponsoring pharmaceutical companies of all other registered Cox-2 inhibitor drugs.

The results of this review were considered by the Australian Drug Evaluation Committee (ADEC) which made a number of recommendations to restrict the use of these drugs in Australia.

As a result, the TGA will immediately require manufacturers of Cox-2 inhibitors to place new highlighted explicit warnings in product information about the increased risk of cardiovascular adverse events from this group of drugs. The new warning statements are to be highlighted with a black boxed margin.

The TGA is also advising people who are taking more than 200mg a day of celecoxib (Celebrex) or more than 15 mg a day of meloxicam (Mobic; Movalis) to review their treatment regime with their doctors.

The TGA believes that most Australians using these drugs will be taking low doses that already meet this dosage advice, but some patients, particularly with rheumatoid arthritis or a rare bowel condition, may be taking 400 mg or 800 mg of celecoxib a day and some patients with arthritis may be taking more than 15 mg of meloxicam a day.

This recommended dose reduction may result in some patients with arthritis having increased symptoms but the review of Cox-2 inhibitors clearly indicated there is an increased risk of heart attacks and strokes with high doses of these drugs.

ADEC reviewed evidence of six drugs in the Cox-2 inhibitor family, all of which were considered to be have risks associated with their use.

It determined that the exact size of the risk and the exact duration of therapy associated with increased risk are still unknown, and so have recommended that Cox-2 inhibitors should be prescribed only when other treatments cannot be tolerated or have caused serious adverse effects.

In addition celecoxib and meloxicam should not be prescribed for patients with increased risks of cardiovascular events, such as heart attacks, and treatment should be limited to the shortest time needed.

Concerning celecoxib, the Committee took into account the results of a study of celecoxib 800 mg a day in low cardiovascular risk patients which showed an increased risk of cardiovascular event. The results of studies of 400 mg a day of celecoxib in low cardiovascular risk patients are conflicting with one study at this dose level finding an increased risk.

On the other hand, several recently published papers describing observational studies of patients using large linked medical record databases in North America have not reported an increased myocardial infarction risk with celecoxib. Dose analysis was not undertaken in all studies but it is likely that a large majority of patients were taking 200 mg/day or less. Such observations are consistent with the preliminary results of an Australian case-control study, the results of which were made available to ADEC. An increased risk of acute coronary syndrome was not found for the patients that were studied. Very few of these Australian patients were taking more than 200 mg a day of celecoxib.

Concerning meloxicam, there are theoretical grounds for regarding the drug as having reduced cardiovascular risks. The drug has less selective Cox-2 inhibition than celecoxib or rofecoxib. Clinical study data are more meagre, with most studies limited to no more than six months duration. The Committee notes that a Prescription Event Monitoring study in the UK and an observational study in Quebec, Canada, provided reassurance that the cardiovascular risk at up to 15 mg is acceptable. ADEC recommended that further research be conducted.

The new requirements reinforce and extend advice given to Australian heath care professionals in the Australian Adverse Drug Reactions Bulletin, October 2003, and repeated in December 2004.

The TGA has also accepted a number of other recommendations of ADEC and has given notice to the relevant companies:

-- it is proposed to cancel the registration of the drug parecoxib (Dynastat) because of the risk of cardiovascular events. Dynastat is marketed in Australia and is approved as a single dose at the time of surgery to reduce post-operative pain;

-- it is proposed to withdraw the indication of management of arthritis of the drug valdecoxib (Valdyne, Dynoral - known in some countries as Bextra) which is converted to parecoxib in the body. Valdecoxib has not been marketed in Australia. Valdecoxib has been associated with an increased risk of cardiovascular events in cardiac by-pass graft patients. The use of Valdecoxib for 5 days as an analgesic in patients without increased cardiovascular risk will remain;

-- it is proposed to greatly limit the approved uses of two other Cox-2 inhibitors which have not yet been marketed in Australia. They are etoricoxib and lumiracoxib. In both instances, ADEC was not sufficiently assured of the safety of these drugs for anything other than short term use in patients without increased cardiovascular risk.

Concerning parecoxib and valdecoxib, ADEC noted reports of two published studies in which valdecoxib alone for 14 days and parecoxib followed by valdecoxib for 10 days were associated with increased risk of cardiovascular events in patients undergoing coronary artery bypass graft surgery. The Committee was not assured from other available data that the safety of parecoxib in other surgical patients or the safety of valdecoxib other than when used for short periods in patients without cardiovascular risk, had been studies adequately.

Printable version of Expanded information on Cox-2 inhibitors for doctors and pharmacists media statement

People who are concerned about their use of Cox-2 inhibitors should discuss their treatment with their medical practitioner.

Dr John McEwen
Principal Medical Adviser
10th February 2005
This is a press release from the Australian Dept of Health
Panel OKs Merck's Vioxx Return to Market
Fri Feb 18, 2005 07:45 PM ET
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Reuters Television
FDA Panel Backs Pain Drugs

By Lisa Richwine and Susan Heavey

GAITHERSBURG, Md. (Reuters) - Merck & Co. Inc.'s (MRK.N: Quote, Profile, Research) withdrawn arthritis drug Vioxx is safe enough to rejoin Pfizer's rival pain relievers Celebrex and Bextra on the U.S. market, an advisory panel said after concluding that all three medicines posed some level of heart risk.

The 17-15 vote on Vioxx's safety to go to market electrified Merck shares, which closed up 13 percent at $32.61 on the New York Stock Exchange. Pfizer Inc. (PFE.N: Quote, Profile, Research) gained 6.9 percent to close at $26.80.

It was a stunning turnaround for Vioxx, which was withdrawn in September by Merck after a study showed the drug doubled heart attack and stroke risk compared with a placebo in patients who took it for at least 18 months.

Celebrex and Bextra, which had been under the same cloud of elevated risks of heart problems, also could stay on the market, the panel said. Most members felt all three drugs should have "black box" warnings -- the strongest warnings used for prescription drugs -- explaining their heart risks.

Many urged restrictions if Vioxx is sold again, such as limiting sales to the lowest dose and recommending it be a second choice after patients try another pain reliever.

John Cush, a rheumatologist at Presbyterian Hospital in Dallas, said the risk of heart problems with Vioxx was "still very small" and he wanted "as many options for my patients as possible."

One opponent to Vioxx sales, panel Chairman Alastair Wood, said "there's a clear signal this drug appears substantially worse than the others" in its potential to damage the heart. Celebrex seems to be the safest of the three based on what scientists know now, he said.

The FDA usually follows advice from its panels. Officials said the agency will make final decisions on Celebrex and other pain relievers in the next few weeks.

"Merck has appreciated the opportunity to present data at this advisory committee meeting," the company said in a statement. "We look forward to discussions with the FDA."

Most panelists wanted to forbid drug makers from advertising the COX-2 drugs. The FDA cannot order an advertising ban but will consider asking the manufacturers to do so voluntarily, said Dr. John Jenkins, head of the FDA's Office of New Drugs.

Celebrex, Bextra and Vioxx are part of a family called COX-2 inhibitors. The drugs were designed to ease pain as effectively as older, nonprescription drugs known as nonsteroidal anti-inflammatory drugs, or NSAIDs, while being easier on the stomach. NSAIDs include more than 20 drugs such as ibuprofen and naproxen. Continued ...

© Reuters 2005. All Rights Reserved.[end quote]

From the San Diego Union Tribune news Feb 19,2005:


FDA panel allows sale of disputed painkillers

Tight rein is urged on Vioxx, 2 other drugs

By Marc Kaufman

February 19, 2005

WASHINGTON – A Food and Drug Administration panel narrowly voted yesterday in favor of allowing the arthritis painkiller Vioxx back on the market under strict conditions. The committee also voted in favor of allowing Celebrex and Bextra to remain available.

But a substantial majority of the 32-member expert advisory panel recommended steps to significantly restrict the drugs' use and called for extensive new testing of similar arthritis medications on, or coming to, the market.

Several panel members said patients in need of pain relief should first try naproxen, sold as Aleve, before taking any of the three painkillers – Celebrex and Bextra, made by Pfizer, or Vioxx, made by Merck.

The panel voted 31-1 that Pfizer should be allowed to continue selling Celebrex, which members said was safer than the other two. The vote on Bextra was 17-13 with two abstentions, and on Vioxx it was 17-15.

The proposed restrictions include a ban on direct-to-consumer advertising, the inclusion of a strong warning in a highlighted black box on the bottle's label or box, and a requirement that patients be given a written warning that the drugs increase the risk of heart attacks and strokes.

Chairman Alastair Wood said the panel's message is that issues raised by the class of drugs known as Cox-2 inhibitors are "extremely complex" and "there are no black-and-white answers." He said that while the group clearly believes drugs used to treat chronic pain are valuable, they need substantially more testing and should not be aggressively advertised, as they had been until the fall.

Although the votes supported controlled marketing of the drugs, the sometimes sharply divided panel hardly gave them a vote of confidence. The votes came only after the advisory group agreed unanimously that Cox-2 drugs "significantly increase" the risk of heart attacks and strokes.

"It would be a brave man or woman who started a patient with a clear history of heart disease on these drugs," Wood said in a briefing after the meeting.

Dr. John Jenkins, director of the FDA's Office of New Drugs, agreed, saying the panel had made clear "that they felt that these agents should maybe not be as widely used."

The FDA usually follows advisory panels' recommendations, especially on controversial issues, but is not bound by them. The agency is expected to make its decisions within weeks.

Celebrex and Vioxx were approved in the late 1990s and were advertised aggressively as breakthrough treatments for arthritis. Millions of patients began taking them, though studies have shown that many were not at risk for the gastrointestinal problems sometimes caused by older painkillers, which the newer drugs were designed to avoid.

In addition to voting on whether the Cox-2 drugs should remain available to U.S. consumers, the panel was asked to assess the safety of nonsteroidal inflammatory drugs such as Mobic and ibuprofen. The group overwhelmingly recommended that they, too, carry new warnings; however, there was a consensus that some of them – naproxen in particular – are much safer than others.

Ibuprofen is sold as a generic drug and by the brand names Advil and Motrin; naproxen is sold under the brand name Naprosyn as well as Aleve.

Just before the voting began, Wood told the group that it was struggling with the biggest and most complicated drug safety issue to come before the FDA. He said that of the 16 drugs the FDA has taken off the market, none has affected nearly as many people because they involved relatively rare side effects and not a general cardiovascular threat.

The restrictions proposed by the panel, if adopted by the FDA, will make Cox-2 drugs much harder for manufacturers to sell and for patients to obtain. Once the FDA gives a drug a black-box warning, certain kinds of advertising are no longer allowed, and doctors tend not to prescribe it widely.

Still, the Vioxx vote in particular was a vindication of sorts for Merck, which pulled its product in September because of safety concerns. At the time, the company said it believed Vioxx could remain on the market with restrictions, but it decided not to do so because there were alternatives with fewer safety concerns.

The drug's possible path back to the market remains difficult. FDA officials told the panel that if Merck wants to return Vioxx to the market, the company must win new approval for revised label information about safety and how the drug should be used.

Merck officials said they are open to returning the drug to the market and that "we look forward to discussions with the FDA" regarding Vioxx and other Cox-2 products in the pipeline.

Sen. Charles Grassley, R-Iowa, who has been highly critical of the FDA's handling of Vioxx, commended the panel for its "respect for the scientific process."

But, he added, "I remain troubled by the FDA's reluctance to be fully transparent. . . . Specifically, the FDA should value the science of its own employees at least as much as the science presented by drug companies."

In its recommendations on restrictions, the panel made clear that it thought they should be tightest on Vioxx – which showed the most significant cardiovascular problems in recently stopped clinical trials.

The FDA convened the extraordinary three-day meeting to solicit recommendations from some of the top experts in the nation on arthritis treatment and overall drug safety. The meeting was called because of the Vioxx withdrawal and similar health concerns linked to Celebrex and Bextra.

Although the panel members were convinced that the Cox-2 drugs carry increased risks of heart attacks and strokes, they voiced differing views on how much the drugs benefit patients and whether they are significantly safer than older anti-inflammatory drugs such as ibuprofen and aspirin. Also weighing on the panel was public testimony Thursday in which many arthritis sufferers pleaded to be allowed to continue using Cox-2 drugs.

During a news conference after the votes, the FDA's Jenkins said the agency will give great weight to the panel's recommendations and comments. But he said the narrow margins of some votes mean the agency must look carefully at the members' comments.

"Close votes are very challenging to interpret," Jenkins said.

Merck shares surged $3.76, or 13 percent, to close at $32.61 yesterday on the New York Stock Exchange. Pfizer shares gained $1.74, or 6.9 percent, to finish at $26.80.

The New York Times News Service contributed to this report.[end quote]


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