It is important that you understand your legal rights. If you or a loved one suffered a stroke or heart attack while taking Vioxx, you may have a case. That determination can only be made after a careful consultation with an attorney.
There are strict time limits for starting a lawsuit that vary from state to state called a statute of limitations. It is very important that you contact an attorney as soon as possible.
Have our attorneys contact you directly.
MERCK LOSES FIRST VIOXX LAWSUIT
August 22, 2005
Associated Press, revised
ANGLETON, Texas (AP) -- Merck & Co.'s first wrongful-death verdict over its painkiller Vioxx came in a case that was not seen as especially strong, and is likely to inspire thousands of more suits on top of the 4,200 already filed against the drug maker, analysts say.
Analysts have already estimated Merck's liability could be as high as $18 billion and that number could now rise.
Merck & Co.'s stock sank $2.22, or 7 percent, to $28.19 after the jury awarded $253.4 million in damages to a widow of a man who died in 2001 of heart arrhythmia, or irregular heart beat, after taking Vioxx for around eight months. The company plans to appeal.
Merck yanked the popular pain reliever from the market last September after a study found it doubled patients' risks of heart attacks and strokes after 18 months.
The loss is especially damaging because Merck initially had been expected to win what was considered a weak case because no studies have linked Vioxx to arrhythmia. And the next two cases Merck faces appear somewhat stronger, according to experts.
"If they can't win the weak ones, what does that say about the strong ones?" asked Anthony Sebok, a professor at
Analyst Jason Napodano of Zacks Investment Research said now anyone taking Vioxx with any type of a cardiovascular problem will feel emboldened to file a lawsuit. So far, more than 4,000 cases have been filed, some presumably stronger than the Angleton case. Merck has set aside $675 million to fight them.
"A Merck loss means that the number of cases against them increases tenfold," predicted Napodano.
If this verdict marks the beginning of a losing streak, Merck may back away from its pledge to try each case individually and not settle any, experts said. But they said a rash of verdicts would be necessary before the company changes its strategy.
"Merck says there will be no surrender. But you have to wonder if that will be true," said Sebok.
Next month, Merck faces a trail in
In November, the first of 1,800 federal cases will be heard in
(Copyright 2005 by The Associated Press. All Rights Reserved.)
VIOXX SUIT FAULTS ANIMAL TESTS
July 22, 2005
Wired News
Animal tests are required to get FDA approval but are normally conducted only prior to human testing, according to Marv Shepherd, director of the Center for Pharmacoeconomic Studies at the University of Texas. Shepherd said that it is "out of the norm" for animal tests to be conducted after Phase 1 and 2 clinical trials on humans have been completed. "I don't know of any drug that has gone backwards like that," said Shepherd, whose research focus includes the drug industry and the FDA approval process. Shepherd said that during drug development, researchers will sometimes change the species if the results of the animal studies conflict with human test data. The response to medications can vary widely between breeds of the same species, according to Shepherd. The relevance of animal models also depends on the type of test, Shepherd says. While antibiotic models work well for animals, tests that deal with the central nervous system do not. Pippin said the Vioxx test results prove that animal studies should not be relied on when developing drugs for humans. "When you do those (types of) studies in animals, you can't predict that the same will happen in humans," Pippin said. "The scientific argument is that (animal testing) just doesn't work and leads us to disasters." Merck stopped selling Vioxx, which the FDA approved in 1999, after a Merck study of the drug's effect on preventing colon polyps showed increased risk of heart ailments if the drug was used for longer than 18 months. In response to the PCRM lawsuit, Merck issued a statement saying that in addition to the animal study, the company also relied on a study of Alzheimer's patients in which "the data did not suggest an increased risk (of heart ailments) with Vioxx," and that during the VIGOR study, naproxen showed consistent bleeding effects with aspirin. The statement also said Merck conducted its green-monkey study after the VIGOR study in response to an FDA request for an animal model study. FDA spokeswoman Laura Alvey declined to confirm any such request, but provided a timeline of FDA Communications with Merck that did not include references to animal tests after Vioxx was released.
The first of the Vioxx lawsuits to come to trial is under way in Angleton, Texas. It was filed on behalf of the estate of Robert Ernst, a 59-year-old avid runner who died after taking Vioxx for six months.
A SELF-IMPOSED BAN ON DRUG ADS
June 17, 2005
The New York Times
The drug maker Bristol-Myers Squibb said yesterday that it had imposed a ban on advertising its new drugs to consumers in their first year on the market, adopting voluntary restrictions that go further than what is anticipated in an industrywide advertising code to be announced next month.
The company said it wanted to give doctors time to understand new products before patients begin asking for them.
"We want to make sure that before we start mass media - television, radio and print branded advertising - that physicians have a level of comfort about the treatment and which patients are appropriate for it," Brian Henry, a spokesman for Bristol-Myers, said.
The 12-month ban is part of a new advertising code the company posted on its Web site yesterday.
Despite the growing backlash against direct-to-consumer advertising of pharmaceuticals, Mr. Henry said the company is not aware of any similar codes in the industry.
In the eight years since the Food and Drug Administration lifted a prohibition on consumer advertising, drug ads have become a $3.8 billion business. The constant drumbeat of spots, mostly on television, is so effective that patients demand prescriptions from their doctors, and some critics accuse the physicians of obliging even though the drugs might not be best for the patient.
The practice has become particularly controversial in the last year in the wake of disclosures that the prescription painkillers known as cox-2 inhibitors were linked to cardiac problems. Advertising and marketing played a role in the widespread use of two of the drugs, Vioxx and Celebrex, by many patients who would have done just as well with less expensive over-the-counter remedies, critics have said.
The Pharmaceutical Research and Manufacturers of America, the trade group, is expected to adopt its industrywide code next month, but apparently will stop short of embracing anything like the 12-month moratorium on advertising new drugs.
"We believe passionately that patients have a right to know about new drugs which may save their lives or improve the quality of their lives," said Ken Johnson, a spokesman for the trade group, known as PhRMA. Mr. Johnson said that the "finishing touches" were being put on the new code, but he would not divulge its contents.
The chief executive of Bristol-Myers, Peter R. Dolan, is slated to become chairman of the industry trade group next year. Mr. Dolan's company has been working to improve its image in the wake of investigations of its accounting practices by the Justice Department and the Securities and Exchange Commission.
Direct-to-consumer advertising became an issue in last year's presidential campaign, with the Democrats holding drug advertising partly responsible for ever-increasing prescription costs and inflation in the nation's health care bills. Lawmakers, both at the federal and state levels, have also embraced the issue.
One bill pending in Congress, sponsored by Representative James P. Moran, a Democrat from Virginia, would ban the broadcast of all erectile dysfunction ads from 6 p.m. to 10 p.m., a measure partly aimed at limiting the exposure to children of the suggestive content of ads for Viagra, Cialis and Levitra.
In addition to placing a 12-month moratorium on consumer advertising of new drugs, Bristol-Myers' code calls for advertising to "appropriate audiences at appropriate times of the day" - a section apparently influenced by ubiquitous erectile dysfunction advertising.
The code also said that all company ads will inform poor patients that assistance programs are available to help them get medications. Bristol-Myers is based in
STUDY SHOWS HOW COX-2 DRUGS DAMAGE HEART
May 26, 2005
HEARTCENTER ONLINE
Researchers at University of Pennsylvania School of Medicine believe they have uncovered another link in the chain of events that causes COX-2 inhibitors to increase the risk of heart attack.
Until 2004, COX-2 inhibitors were some of the most heavily prescribed medications in the United States for the relief of pain and inflammation. In late 2004, however, a study linked Vioxx, a leading COX-2 inhibitor, to increased risk of heart attack. Vioxx was voluntarily removed from the market by its manufacturer. Since then, other COX-2 inhibitors have been linked to heart attack, and one more (Bextra) has also been voluntarily removed from the market.
The researchers at Penn looked at COX-2 inhibitors' effect on the muscular wall of blood vessels. They found that a COX-2-derived fatty acid called prostacyclin controls the blood vessel response to stressors such as high blood pressure. By inhibiting COX-2, the drugs impair the ability of blood vessels to react to high blood pressure.
Combined with earlier research, this study may help physicians understand why COX-2 inhibitors affect the heart and raise heart attack risk even among patients who were previously at low risk.
Other studies have shown that, by suppressing prostacyclin production, COX-2 inhibitors predispose people to high blood pressure, which aggravates atherosclerosis, a condition in which the arteries gradually become clogged with plaque deposits. When the additional factor of impaired blood vessel response is added, it may help physicians better understand, and therefore manage, this class of drugs.
JUDGE SAYS MERCK VIOXX CASES COULD HIT 100,000
May 25, 2005
Associated Press
A federal judge told dozens of lawyers crowded into a New Orleans courtroom Monday that there could ultimately be up to 100,000 cases filed against Merck & Co. over its now withdrawn pain reliever Vioxx, and that he could hear a case as early as the fall. More than 2,000 cases have been filed against the drug maker so far. The pretrial issues for federal cases are being handled by U.S. District Court Judge Eldon Fallon, and lawyers from both sides met here for a monthly status conference. Analysts have estimated Merck's potential liability could reach $18 billion. Merck withdrew Vioxx from the market last September after a study showed it doubled patients' risk of heart attacks and stroke in people taking the drug longer than 18 months.
ONCE ACTIVE MAN JOINS VIOXX ATTACK
May 10, 2005
DenverPost.com
By Al Lewis
John Honea went into semi-retirement at age 48, but now he's in full retirement after taking a drug called Vioxx.
Honea, now 52, was a lieutenant colonel in the Air Force until 2000. He served 30 years. He had physicals every two years that he says showed none of the warnings signs of heart disease. His blood pressure and cholesterol were in check. He never smoked, and there was no family history of cardiac problems.
"When I took my separation physical from the service, they didn't find anything wrong with me," he said. "I thought I was in pretty good shape."
Honea grew up in Dallas and spent his summers camping, hiking and fishing in Colorado, Wyoming and Montana.
After graduating from high school, he joined the Air Force, just as his father had before him. He was stationed in Texas but took assignments at bases across the United States, Germany, Italy and Spain. During the 1991 Persian Gulf War, he went to the United Arab Emirates.
Honea, who stands 6 feet tall, was always athletic, playing baseball, basketball and golf. In the Air Force, he frequently ran 5 miles a day.
In his mid-30s, he developed lower back pain that degenerated into two bulging discs. Over the years, he had physical therapy and surgeries to treat them. And he learned to live with the pain.
In November 2000, a surgeon put him on Vioxx, made by pharmaceutical giant Merck. It was one of a new class of pain-relieving drugs called cox-2 inhibitors and was widely prescribed.
By this time, Honea's two kids were grown. He even had grandchildren. So Honea and his wife of 31 years began building a retirement home in a golf-course community in Montrose, on Colorado's Western Slope.
Honea then got his dream job as a seasonal park ranger at Ridgway State Park.
On May 19, 2002, he helped a group of rangers pull buoys from a lake. His chest and arms ached the next day. "I thought I'd just strained something," he said in a plain-spoken Texas drawl. "I thought I'd just overdone it with those buoys."
When his jaw tightened up, he finally decided to go to the emergency room. There, doctors confirmed he had had a heart attack.
"That was like a jolt out of nowhere," Honea said. "That was the last thing I was expecting them to tell me."
Fortunately, the blockage was in a minor artery and could be treated with angioplasty. A year later, Honea had a stent installed to reopen one of his major arteries. He's now on several medications to keep his blood pressure extremely low. It also keeps him in a permanent lull: "It's like having a governor on your heart."
He had to quit his job as a park ranger. He can't go on long hikes anymore. So he reads newspapers and watches congressional hearings on cable TV.
He knows that in May 2000 - before he started taking Vioxx - top Merck executives declined to study evidence that Vioxx might pose heart risks. He also knows that in September - more than two years after his heart attack - Merck finally pulled Vioxx from the market.
Last week, a House committee released documents that indicate Merck told its 3,000 salespeople to avoid discussing the cardiovascular risks of Vioxx.
Honea is just one of about 20 million folks who took Vioxx after the U.S. Food and Drug Administration approved it in 1999. FDA safety officer David Graham last year said that Vioxx has caused as many as 140,000 heart attacks and strokes and killed up to 55,000 people.
Merck is facing lawsuits from thousands of people but has said that it will defend itself against each case. The causes of heart attacks, after all, are usually complicated and difficult to pinpoint.
"I have mixed feelings about medical malpractice suits," Honea said. He believes Vioxx has taken years off his life, so he has contacted a Denver malpractice attorney, who is preparing his case.
Honea said that in the 1970s, he had a friend who drove a Ford Pinto. Honea often rode in that car, and he remembers how long it took Ford executives to admit that the Pinto's gas tank was prone to exploding in minor rear-end collisions.
"This is like Ford Motor Company and the Pinto all over again," he said. "This is a corporation putting profits over any reasonable regard for people's lives."
MERCK TOLD SELLERS TO AVOID TALK OF VIOXX HEART RISK
May 5, 2005
The Boston Globe
By Diedtra Henderson
Merck & Co. trained an army of employees visiting doctors' offices to avoid discussing negative studies about Vioxx despite mounting evidence that the arthritis painkiller caused heart attacks and strokes, according to company documents released yesterday at a congressional hearing.
The hearing came the same day that embattled Merck chief executive Raymond Gilmartin was replaced by Richard Clark, a company veteran.
Members of the House Committee on Government Reform yesterday blasted the drug maker for willfully misleading doctors even after a Food and Drug Administration advisory committee asked it to alert physicians to Vioxx's heart risks.
A Merck representative testified that its 3,000-person sales staff simply conveyed the drug's known risks, as outlined on the Vioxx label.
The Senate has held scores of hearings on Vioxx and drug safety since Sept. 30, when Merck pulled Vioxx from the market after a study showed it increased the risk of heart attacks and strokes when taken at high doses for at least 18 months. It remains uncertain what may come of House investigative work that uncovered 20,000 pages of training documents and memoranda circulated among the company's senior executives.
According to those internal documents, the company focused on details such as how long its representatives shook hands with doctors and whether they maintained eye contact. But the overarching goal was to increase the number of prescriptions for Vioxx, which arrived on the market after Celebrex, another painkiller.
US Representative Elijah Cummings, a Maryland Democrat, said the panel also should hold a hearing with Pfizer Inc., manufacturer of Celebrex, the only painkiller in the same class as Vioxx that is still on the market. Pfizer last month pulled its other cox-2 inhibiting painkiller, Bextra, under pressure from the FDA. Such drugs work by selectively blocking the cox-2 enzyme that is associated with pain and inflammation.
Solid evidence of heart problems caused by Vioxx began to crop up as early as March 2000. The drug's label was not updated to reflect the risk until April 2002.
According to company documents, representatives known as ''detailers" were told by superiors to sidestep questions about heart risks. If a doctor expressed concern, they were told to produce a pamphlet written by the Merck marketing department that said Vioxx was eight times safer for hearts than similar painkillers. The pamphlet did not include details from the Merck study that showed a fivefold increase in heart attack and stroke risk with Vioxx compared with naproxen, another painkiller.
Dennis Erb, Merck vice president of global strategic regulatory development, said the information on the card was accurate and that detailers were not obligated to discuss details not listed on the drug's label.
US Representative Henry Waxman, a California Democrat, said Merck selectively allowed sales representatives to talk about details not on the Vioxx label. For example, they could say the study met its primary goal by showing Vioxx was less likely to cause stomach bleeding and ulcers.
''Merck has permitted its representatives to provide information outside of its label regarding the benefits of this drug and not the risks. I don't think that is providing education to doctors," Waxman said. ''It's misleading. It withholds from them the information that they most need to know, which is whether Vioxx is dangerous."
Under gentle questioning from US Representative Thomas Davis, the panel's chairman, Erb said the company issued a press release and made conference presentations about the trial. And the results were published in the New England Journal of Medicine.
A ''wide-awake physician" would have known about Vioxx's heart risks, concluded Davis, a Virginia Republican.
Merck faces up to $18 billion in liability from 2,400 Vioxx lawsuits.
The 64-year-old Gilmartin, Merck's outgoing chief executive, was the first outsider hired to head the company in more than a century. He was widely criticized for rejecting an aggressive merger-and-acquisition strategy as the company's profits slipped and its sales leader, Zocor, was poised to lose its patent.
Clark, 59, president of manufacturing, will work with an executive committee led by former Honeywell International Inc. chief Lawrence Bossidy for up to two years.
They will attempt to bring new drugs to market to replace the $2.5 billion in annual sales lost because of Vioxx's withdrawal.
FDA LET MERCK HIDE VIOXX RISK, U.S. LAWMAKERS SAID
May 5, 2005
Bloomberg.com
U.S. regulators failed to stop Merck & Co. from misleading doctors about the heart risks of the Vioxx painkiller before it was pulled from the market last year in the biggest-ever drug withdrawal, U.S. lawmakers said today.
"The case of Vioxx reveals a side of pharmaceutical marketing that is rarely exposed," Waxman said at the hearing. "It is essential for the public, medical professionals and FDA to be aware of what happened here, so we can prevent unnecessary injuries to patients in the future."
|
To contact the reporter on this story: Kerry Dooley Young in
|
EMAILS SUGGEST MERCK MAY HAVE KNOWN OF VIOXX'S RISKS
ABC News
April 25, 2005
Did Merck officials know about the heart risks posed by its now-defunct painkilling drug Vioxx as far back as five years ago?The New York Times reported Sunday that in 2000, Merck overruled one of its own scientists after he suggested that a 73-year-old female patient in a Vioxx clinical trial had probably died of a heart attack.In an e-mail exchange concerning Vioxx, a top Merck scientist repeatedly encouraged the researcher to change his views about the death "so that we don't raise concerns." In later reports to the U.S. Food and Drug Administration and in a paper published in 2003, the company labeled the cause of death as "unknown," the newspaper said.The discussion of the woman's death appears in several previously undisclosed Merck records, including e-mails from Dr. Edward M. Scolnick, Merck's senior scientist from 1985 to 2002, and Dr. Alise S. Reicin, a vice president for clinical research. The messages point to Merck's concerns about data contradicting its view that Vioxx was safe, the Times said.When Vioxx was pulled from the market last September, Merck officials said they had only recently learned that the drug posed a risk of heart attack and stroke. At least 4,600 people or their survivors are suing the drug company, saying Vioxx . a member of a class of drugs called cox-2 inhibitors . caused their heart attacks or strokes. The e-mails and other internal Merck documents, including the report of the woman's death, were given to the Times by an unnamed source working with plaintiffs, the newspaper said.A lawyer for Merck told the Times that the company had disclosed all information from clinical trials about Vioxx to the FDA. And Scolnick's e-mails "merely reflected his concern that the FDA weigh Vioxx's benefits and risks fairly. The e-mail discussion between the Merck scientists reflected an honest scientific debate over the cause of the woman's death," the newspaper reported, paraphrasing the lawyer.Earlier this month, another cox-2 drug, Bextra, was withdrawn from the market for the same cardiovascular concerns. A third cox-2, Celebrex, remains available to U.S. consumers, but the FDA has mandated that it carry a strong "black box" warning label indicating the potential for long-term heart risks.
SALEM - A bill that would expand the number of people who can sue because of health problems caused by Vioxx and Bextra got its first hearing in the Senate Thursday.
Prior to 2004, state law required victims in such cases to file their lawsuit within two years after suffering their injury.
But for some users of Vioxx and Bextra, also known as Cox-2 inhibitors, the statute of limitations ran out before the drugs were found to cause heart disease, lobbyist Brad Higbee told the Senate Judiciary Committee.
Higbee, representing a group called Vioxx Victims United, said the deadline unfairly restricted some patients' right to sue. Representatives of the pharmaceutical industry countered that the limitations are set up to balance the rights of consumers and manufacturers.
The bill, which only deals with the Cox-2 drugs, would change the deadline for filing lawsuits to two years after the cause of an injury is discovered. For Vioxx users, that would be Sept. 30, 2004, the date it was removed from the market.
"Many here today are here because they need your help," Higbee said, referring to a panel of witnesses, some in wheelchairs.
Toni Yukert, 57, was taking Vioxx for arthritis in August 2002 when her husband found her on the floor of their home, having suffered a massive stroke.
Mike Yukert testified that his wife, who sat in a wheelchair beside him, cannot speak and is paralyzed on her right side because of the stroke he believes was caused by Vioxx.
"Imagine how frustrated you'd feel if, simply because you live in Oregon, that we cannot have our day in court," Mike Yukert said.
As many as 140,000 Americans were injured and up to 60,000 died from taking Vioxx, according to an estimate from David Graham, a drug safety researcher with the Food and Drug Administration.
In many states, those who took Cox-2 drugs and suffered from medical problems can still file a lawsuit against the drug companies.
The 2003 Legislature passed a law that said such lawsuits can be filed within two years after the cause of an injury is discovered, which is what the Vioxx users are seeking. The new deadline, however, only applied to injuries that happened after 2003.
That blocks Yukert's wife from seeking damages because her stroke happened in 2002.
Witnesses said people who took the drug more than two years before they were pulled from the market are treated unfairly because they had no way to know the cause of their heart attack or stroke by the time the statute of limitations ran out.
But Jim Gardner, a representative for the Pharmaceutical Research and Manufacturers of America, said statutes of limitation are meant to "balance a consumer's right to adequate recourse in product liability actions and a manufacturer's right to be protected from unlimited exposure to lawsuits."
Gardner also said the bill could have a "chilling effect on a prescription drug manufacturer's decision to do business in the State of Oregon," and said that current law adequately protects citizens.
The committee took no action on the bill.
MERCK & CO. CHANGES TUNE
A Merck & Co. official said Wednesday that all painkillers in the same class as the company's Vioxx could cause heart problems or strokes, a change from the drug-maker's earlier position that such health issues appeared limited to its drug.
Dr. Ned S. Braunstein, senior director of Merck Research Laboratories, told two panels of Food and Drug Administration advisers that since the company pulled Vioxx from the market last year, studies suggesting similar problems with Celebrex and Bextra have changed his mind.
"The data strongly suggest it is a class effect," for all drugs of that type, Braunstein said.
The drugs, designed to help people in chronic pain from conditions such as arthritis, are known as Cox-2 inhibitors. At least two other Cox-2 drugs are awaiting approval from the FDA, Arcoxia from Merck and Lumiracoxib from Novartis Pharmaceuticals.
The panels plan to discuss those drugs Thursday.
The two advisory committees are holding a joint three-day session to gather data on the safety of Cox-2 drugs and to make recommendations regarding their future use.
Recommendations could range from limiting these drugs to people not known to be at risk of heart problems, reducing the dose or duration of use, requiring tougher warning labels and even taking the drugs off the market.
Merck pulled Vioxx off the market Sept. 30 after a long-term study showed a higher rate of strokes and heart problems in people using the drug.
A panel of federal judges on Wednesday assigned all pending Vioxx product liability lawsuits against Merck to Judge Eldon E. Fallon in Louisiana, who is experienced in major pharmaceutical litigation.
There were preliminary indications of heart problems with the painkiller Vioxx before it was withdrawn, but it was difficult to sort through conflicting data, a health official said Wednesday at the opening of hearings on the risks of popular painkillers.
"We were not asleep at the wheel, we were actually engaged in reviewing a lot of data," Dr. Lourdes Villalba told a joint meeting of the FDA's arthritis advisory committee and its drug safety and risk management advisory committee, which are looking into Vioxx, Celebrex and Bextra.
CBS News Early Show Medical Correspondent Dr. Emily Senay reports the hearings are an attempt to answer why these drugs ended up on the market in the first place.
"How was it that risk factors for cardiovascular events like stroke and heart attacks, which were clearly there in some of the early studies, were not taken more seriously?" Senay asked. "These drugs were better than approved by the FDA, and yet, we're at the place in time when we're questioning whether or not they should be on the market."
Related drugs Celebrex and Bextra, made by Pfizer Inc., remain on the market, though some studies have also indicated they, too, may carry an added heart risk.
Villalba, medical officer responsible for Vioxx at the FDA's Center for Drug Evaluation and Research, pointed out that a study done in 2000 comparing Vioxx with the painkiller naproxen, showed a higher rate of heart problems with Vioxx, but other studies had conflicting results. In discussions with Merck officials, she said, the company suggested naproxen might have a heart protective effect.
Nonetheless, in 2002 the agency required an added warning on the Vioxx label urging caution in prescribing it for people with heart conditions.
"We never bought the naproxen theory," she said, and Merck officials said they no longer make that argument.
Pfizer vice president Dr. Joseph M. Feczko said the reports of increased heart problems need to be seen in context, considering that these drugs, known as Cox-2 inhibitors, bring an important benefit by reducing the sometimes serious stomach and intestinal problems that occur with many painkillers.
Dr. Kenneth M. Verberg, Pfizer vice president for inflammation and immunology, defended Celebrex as safe, though he said there is little data on use of the drug for more than one year. Further long-term testing of Celebrex is needed, he said.
Earlier, Dr. Ned S. Braunstein, senior director of Merck Research Laboratories, reported that the biggest increase in heart problems occurred after 18 months of use.
Earlier in the day, Dr. Garrett FitzGerald of the Department of Pharmacology at the University of Pennsylvania School of Medicine told the committees that, considering the hazard reports, similar new drugs may have to face tougher testing to win approval and those on the market ought to be put through the same new testing to retain approval.
FitzGerald told the panels that, just as low-dose aspirin affords heart protection and a small but definite risk of stomach and intestinal problems, so the Cox-2 inhibitors "afford gastrointestinal protection and a small but absolute risk of cardiovascular events."
CBS' Aleen Sirgany reports, FitzGerald said: "We're likely to subject new drugs in this class to hurdles before they're approved. Existing drugs should be subject to the same hurdles."
The two committees are holding a joint three-day session to gather data on the safety of the drugs and to make recommendations regarding their future use.
Recommendations could range from limiting these drugs to people not known to be at risk of heart problems, reducing the dose or duration of use, requiring tougher warning labels and even taking the drugs off the market.
As the session began, the FDA promised prompt action on recommendations from advisory committees.
Dr. Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, reminded the committees that the drugs in question are important painkillers widely used by people in chronic pain. It is important to balance the risks of drugs with their benefits, he said.
A drug that has a positive risk-benefit balance for the population as a whole, Galson added, may still cause serious problems for some individuals.
The FDA has been criticized for being slow to recognize problems with these drugs.
However, committee chairman Dr. Alistair J. Wood of Vanderbilt University stressed as he opened the session that the committee "is not here to delegate blame or revisit the past."
On Tuesday, the Health and Human Services Department announced that the FDA will establish a new Drug Safety Oversight Board to monitor medicines once they're on the market and will update physicians and patients with emerging information on risks and benefits.
The Health and Human Services Department announced Tuesday that the FDA will establish a new Drug Safety Oversight Board to monitor medicines once they're on the market and will update physicians and patients with emerging information on risks and benefits.
But as CBS News Correspondent Sharyl Attkisson reports, skepticism exists . even within the FDA . over whether such a drug review panel will work.
Attkisson spoke with FDA Dr. David Graham, who recently studied such drugs as Celebrex and Mobic, an alternative pain medication, with a doctor at Stanford University. Graham said his and other similar studies are not only not being encouraged by the FDA, but they are being withheld from the public.
Graham has been critical of the FDA before, alleging it repeatedly kept the public in the dark over potentially dangerous drugs. He said if the FDA worked in the public interest, it would encourage him to present his study.
"You would think that if the FDA were working for the public and were interested in drug safety that that would be their reaction," Graham told Attkisson.
FDA OPENS HEARINGS ON ARTHRITIS DRUGS
The Associated Press
February 16, 2005
The Food and Drug Administration promised prompt action Wednesday on recommendations from advisory committees probing the safety of popular painkillers, but urged the advisers to balance the risks and benefits of the drugs.
Vioxx was pulled from the market Sept. 30 after a long-term clinical trial indicated some patients suffered heart attacks or strokes. Similar safety questions have risen concerning the related drugs Celebrex and Bextra.
The advisory committees are hearing from government officials, physicians, researchers and the public in three days of meetings before voting on recommendations for these prescription drugs, known as Cox-2 inhibitors.
Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the agency will act rapidly _ in the next few weeks _ on the committee recommendations. The FDA is not required to accept such recommendations, but generally does.
Galson reminded the group that the drugs in question are important painkillers widely used by people in chronic pain. It is important to balance the risks of drugs with their benefits, he said.
A drug that has a positive risk-benefit balance for the population as a whole, Galson added, may still cause serious problems for some individuals.
The FDA has been criticized for being slow to recognize problems with these drugs.
However, committee chairman Dr. Alistair J. Wood of
Vioxx was withdrawn by its manufacturer, Merck & Co. Celebrex and Bextra, made by Pfizer Inc., remain on the market.
The editor of a leading medical journal has questioned whether patients should continue using the drugs.
"Because there are well-established options for treatment of all the approved indications for these drugs, it is reasonable to ask whether the use of the drugs can now be justified," Dr. Jeffrey M. Drazen, editor of the New England Journal of Medicine, said in an editorial published online Tuesday.
© 2006 Vioxx Drug Recall