Yourlawyer.com (Vioxx News)

Merck Loses Vioxx Appeal

Thu, 01 Oct 2009 00:00:00 -0700

The New Jersey Supreme Court has thrown out a Merck & Co. appeal of a $4.5 million Vioxx award. According to a Business Week report, the dismissal ended the last unresolved Vioxx patient lawsuit.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. However, the painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

The withdrawal prompted thousands of product liability lawsuits that claimed Merck didn’t properly warn doctors and patients of the drug’s risks. To settle most of those suits, Merck established a $4.85 billion fund in November 2007. The New Jersey lawsuit Merck appealed - McDarby v. Merck - was one of a few not included in the settlement, Business Week said.

According to Business Week, McDarby v. Merck was filed on behalf of John McDarby, who suffered a heart attack in 2004. He passed away from complications related to the heart attack in 2007. According to Bloomberg News, a jury had originally awarded his family a total of $13.5 million in damages, including $9 million in punitive damages in 2006. A lower New Jersey appeals court threw out the punitive damage award while upholding the jury’s compensatory damage finding, reducing the award to $4.5 million

According to Bloomberg, Merck still faces 18 suits filed by governmental agencies alleging the company violated consumer-protection laws with its marketing of Vioxx.

Vioxx Settlement Fund Will Pay 3,000+ Death Claims

Tue, 29 Sep 2009 00:00:00 -0700

The $4.85 billion Vioxx settlement announced by Merck & Co. in 2007 will include payments to the families of over 3,000 people who died of a heart attack or stroke while taking the now-withdrawn painkiller, according to a report on Bloomberg.com.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. However, the painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

The withdrawal prompted thousands of product liability lawsuits that claimed Merck didn’t properly warn doctors and patients of the drug’s risks. To settle most of those suits, Merck established a $4.85 billion fund in November 2007. According to this weekend's Bloomberg report, the fund will pay about 3,000 claims for heart attack deaths and at least 122 strokes.

"We don’t know any drug right now with this number of deaths associated with it,” one plaintiffs' attorney who has represented Vioxx victims told Bloomberg.

Families of heart attack victims who died will get an average payment of about $374,000, Bloomberg said. Some will get as little as $5,000 and others more than $1.5 million, depending on the user’s age, how long they took the drug and whether they had health risks such as obesity or hypertension. The fund will also pay “an unspecified number” of claims on behalf of Vioxx users whose deaths didn’t meet the criteria for payments related to the drug’s use.

According to Bloomberg, the law firm administering the $4.85 billion settlement fund says $1.4 billion will be paid to heart attack claimants. The firm will pay most of the balance of the $4 billion fund to more than 20,000 claimants after Sept. 30. Stroke claimants have received $69.8 million of the $850 million so far. Claimants’ lawyers will be paid as much as $1.55 billion of the settlement fund, Bloomberg said.

The settlement does not require that Merck make any admission of causation or fault.

Yet Another Vioxx Settlement

Tue, 04 Aug 2009 00:00:00 -0700

In yet another recent legal settlement, Merck & Co has agreed to pay $80 million to settle 190 claims concerning its recalled pain medication, Vioxx, reports Reuters. In a U.S. Securities and Exchange Commission (SEC) filing, reported Reuters, Merck said it recorded an “$80 million charge” in this year’s second quarter for “the settlement with third-party payors,” including “unions and health insurance plans.”

Last month, we wrote that another settlement was reached in a lawsuit allegedly involving the death of John Henderson, according to the Madison St. Clair Record. Henderson’s wife, Norma Henderson, and her attorneys agreed to accept the proposed settlement in excess of $200,000, said the Madison St. Clair Record. The lawsuit was originally filed against the drug giant on July 9, 2003 and alleged that Vioxx was responsible for the death of Mr. Henderson.

Vioxx was approved for use in the U.S. in 1999, quickly becoming a hit for Merck, with annual sales of $2.5 billion. Vioxx was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to over 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Vioxx was also recalled in over 80 countries that year.

The Vioxx recall spawned thousands of product liability lawsuits and, in 2007, Merck agreed to settle most U.S. Vioxx claims for $4.85 billion. The hundreds of lawsuits that remain are those ineligible for the multi-billion dollar settlement, as well as cases from third-party payors hoping to receive financial compensation monies spent on Vioxx by those payors’ members, said Reuters. Merck also continues to defend lawsuits in other countries, including Australia.

According to Merck’s filing, the recent settlement is for the “190 outstanding private third-party payor claims,” which also include all pending actions in “New Jersey” as well as the “multi-district litigation … consolidated in Louisiana,” reported Reuters. "We can confirm that there have been some discussions with plaintiffs' attorneys about possible resolution of the litigation, but we cannot comment beyond what's been reported in the filing," said Merck spokeswoman Amy Rose, quoted Reuters

Recently, Merck said it was advised, also in the second quarter, that the SEC ended its formal probe of its activities relating to Vioxx, said Reuters, noting that the informal probe that began in November of 2004 was elevated to a formal investigation in January of 2005.

In other recent news, a lawsuit emerged last month in the United States naming a number of federal lawmakers as defendants, including U.S. democratic senators Patrick Leahy (Vermont), Russell Feingold (Wisconsin), and Edward Kennedy (Massachusetts), said Highlands Today in a prior report.

Of interest, the Vioxx trial that is ongoing in Australia has shed new light on the questionable tactics Merck used to market its dangerous painkiller. According to The Australian, Merck orchestrated “patient loyalty programs” that, publicly, seemed to be about increasing “quality of life.” Privately, reported The Australian, Merck was only seeking improved “patient compliance” and retention while doubling “sales potential.” Citing marketing briefs presented in court, The Australian said the drug giant presented a patient program in 2002 developed to calm consumer concern about Vioxx safety and “block” the launch of a rival anti-arthritis drug.

Vioxx Trial in Australia Details Merck's Deceptive Strategy

Thu, 14 May 2009 00:00:00 -0700

A Vioxx trial in Australia has shed new light on the questionable tactics Merck & Co. used to market the dangerous painkiller. The strategies, detailed in an article published by The New York Times, will not surprise anyone who has followed this blog's Vioxx coverage.

Vioxx was approved for use in the U.S. in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered the painkiller off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Vioxx was also recalled in more than 80 countries that year.

The Vioxx recall spawned thousands of product liability lawsuits. In 2007, Merck agreed to settle most U.S. Vioxx claims for $4.85 billion. But the company is still defending lawsuits in other countries, including Australia.

We've already reported on one of the most shocking tactics used by Merck to push Vioxx in Australia - the use of a fake medical journal. The journal, published by Elsevier, looked like other peer-reviewed medical journals, but contained only reprinted or summarized articles - all of which presented Merck products, including Vioxx, in a favorable light.

According to the New York Times, Merck published several issues of the "journal", entitled Australasian Journal of Bone and Joint Medicine, between 2002 and 2005. It was presented to doctors as a real medical journal.

The New York Time is also reporting that the Australian trial has revealed that Vioxx sales reps in that country were given a training manual called the “Vioxx Objection Handling Module.” This manual schooled reps in methods of deflecting doctors' questions about the drug's side effects, and easing their concerns. According to The New York Times, Merck began distributing the manual in 2001 as studies began to emerge that pointed to the drug's heart and stroke risks.

The Australian trial has also demonstrated how disillusioned doctors felt when they learned Merck had tried to obscure Vioxx's safety issues. For example, in an e-mail message dated Oct. 2, 2004, Dr. James V. Bertouch, an Australian physician who had been a member of Merck’s arthritis advisory board, told fellow board member that he felt “like the proverbial mushroom” and asked colleagues how they felt being kept in the dark about Vioxx.

Merck Published Bogus Journal

Tue, 05 May 2009 00:00:00 -0700

TheScientist.com broke with the news that Merck & Co., the maker of controversial drugs such as the Gardasil vaccine and recalled Vioxx, paid for publication of a bogus medical journal. It seems Merck paid Elsevier to develop what TheScientist.com described as “several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles.”

Most of the articles in the publication presented Merck products favorably, which makes it seem as if the phony journal was developed for marketing purposes without actually indicating itself as project sponsor, said TheScientist.com. "I've seen no shortage of creativity emanating from the marketing departments of drug companies," said deputy director of the public health research group at the consumer advocacy nonprofit Public Citizen, Peter Lurie. Lurie reviewed two issues of the fake journal, which was obtained by TheScientist.com and added that, "But even for someone as jaded as me, this is a new wrinkle." TheScientist noted that, other than ads for Merck’s Fosamax and Vioxx, there were minimal other advertisements.

News of the questionable, Merck-created journal started surfacing with a report by The Australian and emerged from information from a civil suit filed against Merck by a patient who suffered a heart attack while on Vioxx, said TheScientist.com. George Jelinek, an Australian physician and established member of the World Association of Medical Editors, reviewed four issues and testified at the trial, said TheScientist. Jelinek explained that the "average reader," which in this case, would be a physician, could believe the journal to be "genuine" and peer-reviewed, noting that, "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication," reported TheScientist.

Jelinek noted a good portion of the journal’s articles focused on Merck drugs with favorable verbiage. Adding to the lack of credibility, the so-called review articles contained surprisingly sparse referencing—most review articles are rife with citations and references—with a couple merely being summaries of published work with a notation they were written by "B&J Editorial," which one could infer means “Bone and Joint.” Testified Jelinek, "It appears that 'B&J' (presumably Bone and Joint) refers to the Journal, and B&J editorial presumably to the publishers or owners as there is no editor of the journal. This is a subtle attribution, and many readers may not realise that the paper was written by the owners or publishers of the journal, presuming that is who would write under the heading of 'editorial,’” quoted TheScientist.

A spokesperson for Elsevier told The Scientist, "I wish there was greater disclosure that it was a sponsored journal."

We have been writing about researchers falsifying studies linked to industry funds. A former Harvard researcher, Dr. Robert Fogel, admitted falsifying a medical study and, according to an earlier Boston.com piece, was disciplined by the Department of Health and Human Services (HHS) for faking data in a sleep apnea study funded by federal research grants. Since leaving Harvard, Fogel has been employed by Merck Research Laboratories, where he is now director of clinical research at its respiratory and allergy division in Rahway, N.J.

Legitimate medical journals have been asked to retract drug studies involving Vioxx, Celebrex, Lyrica and other drugs that were conducted by Dr. Scott S. Reuben of Baystate Medical Center; Reuben has strong ties with the pharmaceutical industry, with among others, having received funding from Merck.

Baystate Medical Center Subpoenaed Over Fake Drug Studies

Wed, 08 Apr 2009 00:00:00 -0700

The Baystate Medical Center has received a subpoena as part of a federal investigation into a doctor there who falsified 21 drug studies. According to The Wall Street Journal, the U.S. Attorneys office in Boston is seeking financial records related to the work of Dr. Scott S. Reuben.

As we reported last month, medical journals have been asked to retract studies involving Vioxx, Celebrex, Lyrica and other drugs. All of the studies were published between 1996 and 2008. According to The Wall Street Journal, the journal Anesthesia & Analgesia has retracted 10 studies. It also posted a list of 11 others that were published in other journals on its Web site. The journal Anesthesiology said it has retracted three of Reuben’s articles.

These studies had a great deal of influence on the practice of medicine. Because of Reuben’s “research”, it had become routine for doctors to combine the use of painkillers like Celebrex and Lyrica for patients undergoing common procedures such as knee and hip replacements. Reuben even had the ear of the Food & Drug Administration, and had written the agency asking it not to restrict the use of many of the painkillers he studied. He often cited his fake data to make his case, the Journal said.

Many of the studies Reuben worked on involved drugs that have very serious side effects. Like many antidepressants, the labeling of Effexor warns that it has been linked to suicides in young people and children. Both Celebrex and Vioxx have been linked to heart attacks and strokes, and Vioxx was actually recalled in 2006 because of these problems.

Not surprisingly, Reuben has strong ties with the pharmaceutical industry. According to the Journal, he had been a paid speaker on behalf of Pfizer - the maker of Lyrica and Celebrex - and it paid for some of his research. Wyeth provided $10,000 in grant money to. Reuben from 2001 to 2003, the Journal said. Merck also funded some of Reuben's work.

According to The Wall Street Journal, Baystate Medical is cooperating fully with the federal government's probe of Reuben. A spokesperson for the Springfield, Mass., medical center told the Journal that Baystate isn't a target of the investigation.

Baystate Medical Center has placed Reuben on indefinite leave. He has also vacated an appointment as a professor at Tufts University’s medical school, the Journal said.

Merck Faces Vioxx Grand Jury Probe

Tue, 24 Mar 2009 00:00:00 -0700

Vioxx is the target of a federal probe, Merck & Co. announced yesterday. According to Reuters, the grand jury investigation involves Merck's research, marketing and selling activities regarding Vioxx, which was pulled from the market in 2004.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

After Vioxx was pulled from the market in 2004, it was revealed that the FDA had tried to silence the drug expert who headed that study. Dr. David Graham, associate director for science in the FDA Drug Center’s Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.

The Vioxx recall spawned thousands of product liability lawsuits. In 2007, Merck agreed to settle most of those Vioxx claims for $4.85 billion.

Serious questions continue to be raised about the way Vioxx was marketed. For instance, last April an analysis of court documents uncovered in the course of Vioxx injury lawsuits found that Merck & Co. employees worked alone or with publishing companies to write Vioxx study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. According to the analysis, which was published in the Journal of the American Medical Association, Merck’s involvement in producing the data wasn’t disclosed in many cases.

According to the Associated Press, Merck revealed yesterday that it had received a letter from the U.S. Attorney in Massachusetts notifying the company it is "a target" of a grand jury investigation involving the painkiller Vioxx. Merck has previously disclosed the investigation, which the company said has been ongoing since 2004, the Associated Press said.

The company said it "has responded and is continuing to respond to requests from the U.S. Attorney's Office for documents and information in connection with the ongoing investigation. The investigation also includes subpoenas for witnesses to appear before a grand jury, Reuters said.

Researcher Faked Data for 21 Studies Involving Vioxx, Celebrex and Other Drugs

Wed, 11 Mar 2009 00:00:00 -0700

Medical journals have been asked to retract 21 studies that touted the benefits of Vioxx, Celebrex and other drugs. According to The Wall Street Journal, Baystate Medical Center, Springfield, Mass. is asking the journals to make the retractions because its former chief of acute pain, Dr. Scott S. Reuben, had faked data used in the studies.

In addition to Vioxx and Celebrex, some of the 21 studies involved the fibromyalgia drug Lyrica and the antidepressant Effexor XR. Reuben's study claimed to show that these drug worked well as painkillers, the Journal said. All of the studies were published between 1996 and 2008.

According to The Wall Street Journal, these studies had a great deal of influence on the practice of medicine. Because of Reuben's "research", it had become routine for doctors to combine the use of painkillers like Celebrex and Lyrica for patients undergoing common procedures such as knee and hip replacements, the Journal said.

Reuben even had the ear of the Food & Drug Administration (FDA), and had written the agency asking it not to restrict the use of many of the painkillers he studied. He often cited his fake data to make his case, the Journal said.

According to The Wall Street Journal, Reuben's fraud has caused the journal Anesthesia & Analgesia to retract 10 studies. It also posted a list of 11 others that were published in other journals on its Web site. The journal Anesthesiology said it has retracted three of Reuben's articles.

Not surprisingly, Reuben has strong ties with the pharmaceutical industry. According to the Journal, he had been a paid speaker on behalf of Pfizer - the maker of Lyrica and Celebrex - and it paid for some of his research.

Baystate Medical Center has placed Reuben on indefinite leave. He has also vacated an appointment as a professor at Tufts University's medical school, the Journal said.

Perhaps the most disturbing aspect of this scandal is that many of the drugs Reuben researched have been linked to serious side effects. Like many antidepressants, the labeling of Effexor warns that it has been linked to suicides in young people and children.

Both Celebrex and Vioxx have been linked to heart attacks and strokes, and Vioxx was actually recalled in 2006 because of these problems.

This is actually not the first time the integrity of studies involving Vioxx have come into question. Last April, we reported that an analysis of court documents uncovered in the course of Vioxx injury lawsuits found that Merck & Co. employees worked alone or with publishing companies to write Vioxx study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. According to the analysis, which was published in the Journal of the American Medical Association, Merck’s involvement in producing the data wasn’t disclosed in many cases.

Speedy Drug Approvals Put Patients at Risk

Wed, 03 Dec 2008 00:00:00 -0800

A prominent researcher has charged that pressure to quickly bring new drugs to market may be endangering patients. To often, quick approval means a drug's dangerous side effects are missed, and only discovered years after a medication has been on the market.

In an article he wrote for The British Medical Journal, Dr. David Kao of the University of Colorado Health Sciences Center points out that the U.S. Food & Drug Administration (FDA) had instituted new procedures over the last decade or so aimed at speeding up drug approvals. As an example, Kao points to the 1992 Prescription Drug User Fee Act, or PDUFA. This act allows the agency to impose user fees on drug companies to help speed drug approvals. The act is credited with reducing the average time to approve a drug from 33.6 months during 1979-86 to 16 months by the 1997-2002 period.

But Koa writes that the focus on approving new drugs quickly takes the focus off of dangerous side effects. Under the current system, Koa said new drugs are only tested on a few thousand people at most. The FDA and drug makers then use post-approval surveillance to watch for side effects that didn't become apparent during pre-approval clinical trials.

Koa points out that previous research has shown that drugs approved in the U.S. close to a mandated deadline are more likely to need additional safety warnings later, or even be withdrawn for safety reasons. This can lead to public health disasters, such as what happened with Vioxx. According to Koa, 20 million patients had taken the dangerous drug before it was withdrawn in 2004 - five years after its approval - because of its link to heart attack and strokes.

To protect patients, Koa said he believes that the systems for reporting adverse drug reactions must be improved. He suggests drug makers could play a role in this by using the types of aggressive techniques they already employ to market a new drug. For example, laws in the U.S. already compel TV drug ads to instruct patients experiencing negative side effects to report their symptoms to the FDA. Koa says that the use of other multimedia techniques - such as websites and direct mailings - could be expanded to include campaigns dedicated to drug safety monitoring.

Vioxx, Celebrex, Other Painkillers Up Risks for Heart Failure, Heart Attack Patients

Wed, 12 Nov 2008 00:00:00 -0800

Vioxx, Celebrex, ibuprofen and other NSAID painkillers increase the chances that heart attack and heart failure patients will experience a second heart attack or death, a new study says. According to Danish researchers, the risk of a second heart attack or death actually doubled within the first 90 days of starting Vioxx or Celebrex. Other painkillers, like ibuprofen, increased the risk between 2.1 and 1.3 times.

The study was presented this week at the American Heart Association meeting in New Orleans. At least one of the researchers recommended that physicians now avoid these types of painkillers, or use low doses, in patients with a history of heart attack or heart failure.

For their study, researchers at the University of Copenhagen analyzed the records of 58,432 patients who had a previous heart attack and 107,092 with heart failure in Denmark. Of those, 36 percent of the heart attack patients and 34 percent of the heart failure patients said they took at least one painkiller after they were discharged from the hospital.

Patients who had suffered a heart attack and were taking the painkiller Vioxx had 2.7 times the risk of having another heart attack or dying compared with patients not taking painkillers. Heart attack patients taking Celebrex had double the risk, while those with heart failure taking Celebrex had 2.3 times the risk. Heart attack patients taking diclofenac had 1.9 times the risk, while those taking ibuprofen had 1.3 times the risk, according to the study.

NSAIDs are the most prescribed medications for treating conditions such as arthritis. The Food & Drug Administration (FDA) now requires all NSAIDs to bear a black box warning regarding heart attack and stroke risks. The warnings were added to the drugs after Vioxx was recalled in 2004.

The FDA ordered Vioxx off the market in 2004 after studies showed that people who took the drug had a higher risk for heart attack. The recall came after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Since then, Vioxx the subject of thousands of drug injury law suits.

COX-2 Inhibitors More Likely to Raise Heart Risks Than Other NSAIDs

Wed, 05 Nov 2008 00:00:00 -0800

A new study that confirms the heart risks associated with a class of drugs called NSAIDs has found that the increased risk correlates to the specific pain-causing molecule they act against. According to the study, NSAIDS that are cox-2 inhibitors are more likely to increase the risks of heart attacks and strokes.

NSAIDs are the most prescribed medications for treating conditions such as arthritis. Most people are familiar with over-the-counter, nonprescription NSAIDs, such as aspirin and ibuprofen. NSAIDs also include prescription drugs like Celebrex, as well as the now-banned Vioxx.

NSAIDS target different forms of cyclooxygenase, an enzyme whose activity increases inflammation and pain. Older NSAIDs, such as ibuprofen and naproxen, act primarily against cox-1. Celebrex, Vioxx and Bextra act against cox-2. While cox-2 inhibitors reduce the gastrointestinal bleeding, pain and inflammation that are major side effects of the cox-1 drugs, they have been found to increase the risk of heart attack and stroke.

This latest study, conducted by researchers in Spain and Italy, looked at 8,852 people who had heart attacks. The increase was related to both the dosage and the length of time the drugs were taken. But the risk was increased by 18 percent by NSAIDS that acted against cox-1, compared to a 60 percent increase for those with the greatest cox-2 activity.

"We found a significant correlation between the degree of inhibition in vitro [in the laboratory] of whole blood cox-2, but not whole blood cox-1," said the report by researchers in Spain and Italy.

The Food & Drug Administration (FDA) now requires all COX-2 inhibitors and NSAIDs to bear a black box warning regarding heart attack and stroke risks. The warnings were added to the drugs after Vioxx was recalled in 2004.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. But the FDA ordered Vioxx off the market in 2004 after studies showed that people who took the drug had a higher risk for heart attack. The recall came after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Since then, Vioxx the subject of thousands of drug injury law suits.

Late last year, Merck announced that it would a $4.85 billion settlement with Vioxx plaintiffs. Under the terms of the Vioxx settlement, Merck set up $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. Initial payments for the Vioxx settlement started going out to some plaintiffs last month.

Pfizer Announces Bextra, Celebrex Settlement

Fri, 17 Oct 2008 00:00:00 -0700

Pfizer has reached a tentative agreement to settle lawsuits involving its Bextra and Celebrex painkillers for $894 million. If it goes forward, the Pfizer Bextra and Celebrex settlement will resolve roughly 90 percent of the personal injury lawsuits the company faces because of the drugs.

Celebrex and Bextra are COX-2 inhibitors, a class of drugs that also includes Merck’s recalled Vioxx. Such medications are linked to an increased risk of blood clots, heart attacks and strokes. Pfizer withdrew Bextra from the market in 2005, and Celebrex is the only COX-2 inhibitor still on the market in the United States.

Celebrex carries the Food and Drug Administration’s (FDA) strictest “black-box” warning on its drug label, stating that it may cause an increased risk of serious cardiovascular events such as heart attacks and strokes. Despite its apparent risk, Celebrex continued to generate $2.3 billion in sales in 2007, a 12 percent increase from the previous year.

According to The New York Times, $760 million of the Bextra and Celebrex settlement would go to settle roughly 7,000 personal injury cases, $60 million will cover settlements with attorneys general in the 33 states and the District of Columbia, and $89 million will cover consumer fraud class action cases over reimbursement for money spent on the two drugs.

Pfizer said it hopes to finalize the settlement by the end of the year. A spokesperson for the company said that Pfizer would also like to include many of the remaining personal injury lawsuits the settlement. The company will fight those not settled with court motions or at trial.

COX-2 inhibitors have been the subject of safety worries since 2004, when Merck pulled Vioxx from the market. The FDA ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The Vioxx recall led to thousands of lawsuits.

Last November, Merck announced a $4.85 billion settlement with the thousands of people who had filed Vioxx injury lawsuits. Under the terms of the settlement, Merck set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. Partial settlement payments started going out to some Vioxx plaintiffs last month.

Vioxx Heart Risks Long-Lasting

Tue, 14 Oct 2008 00:00:00 -0700

Heart risks from Vioxx, the defective painkiller pulled from the market in 2004, lingered long after many patients stopped taking the drug. According to a report in The Washington Post, a study conducted by researchers at the M.D. Anderson Cancer Center in Houston, TX found that Vioxx increased the risk of heart attack and stroke by "close to twofold, and the risk persisted for approximately a year".

The authors of the study, which was published online by the journal Lancet, also believe that long-term use of other NSAIDs, including now-banned Bextra, as well as Celebrex, and over-the-counter versions of ibuprofen and naproxen, increase stroke and heart attack risks to some extent.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The Vioxx recall led to thousands of lawsuits.

This latest Vioxx study involved followed people who had participated in the international APPROVe trial, which compared Vioxx to placebo over 3 years in an attempt to see whether the drug could cut the recurrence of cancerous colon polyps. The trial was stopped early in 2004 because of the increased risk for heart attacks and stroke. Nearly 2600 people participated in the APPROVe trial, and the authors of the Lancet study said they were able to contact about 84 percent of them.

According to the study, former Vioxx users still had a 79 percent increased risk of heart attack, stroke or death compared with those who had received placebo. Individual patients faced double the risk of heart attack or stroke in the year after stopping the drug. The increased risk of dying was 31 percent compared with those who had taken placebo, the researchers noted.

Co-author of the study, Dr. Robert Bresalier, told the Washington Post that it is probable that all non-aspirin NSAIDs can increase the risk of cardiovascular problems. "Similar data has been evident for some of the other cox-2 inhibitors," Bresalier said. "In fact, it seems to be a class effect for most if not all NSAIDs."

Bresalier said that certain patients - those with pre-existing cardiac problems - should avoid long-term use of these drugs. However, the risk is small when NSAIDS are taken for short periods of time for intermittent pain relief.

Florida AG Sues Merck for Misleading Marketing

Wed, 01 Oct 2008 00:00:00 -0700

Earlier this week, Florida Attorney General Bill McCollum sued Merck and Company, Inc. for damages caused by the company’s allegedly deceptive marketing and promotion of its prescription drug, Vioxx. The lawsuit states that Merck repeatedly failed to disclose Vioxx’s adverse effects while offering it to Florida’s Medicaid program as a safe painkiller. The Attorney General’s office is charging the Merck violated Florida’s Deceptive and Unfair Trade Practices Act.

Vioxx is a non-steroid anti-inflammatory medication used to treat joint pain and was one of the most widely prescribed and advertised drugs until it was removed from the market in 2004 for serious adverse effects. The lawsuit follows a three-year investigation of Merck’s promotional practices as they relate to Vioxx and alleges that, due to Merck’s marketing practices, many state agencies approved Vioxx as a covered or approved drug and agreed to pay for the prescription or reimburse its expense. Vioxx purchases by the Florida Medicaid program exceeded $80 million between 1999 and 2004.

The Attorney General’s lawsuit claims Merck’s expensive promotional campaign was developed to convince consumers that the drug was not only safe, but that consumers should demand Vioxx from their health care professionals for pain treatment. Merck also allegedly attempted to intimidate physicians and researchers who questioned Vioxx’s safety and may have misrepresented or concealed published evidence, including its own, which detailed Vioxx’s possible harmful side effects. Merck removed its blockbuster arthritis drug Vioxx (Generic: Rofecoxib) from the market worldwide because clinical trial data found an increased risk of heart attack and stroke, blood clots, and other cardiovascular complications.

The Attorney General argues that if the truth about Vioxx had been known earlier, physicians and their Medicaid patients would have chosen other, less expensive prescriptions. The lawsuit demands restitution to the State of Florida, plus interest, for all state program payments, which includes Medicaid reimbursements, that were made for Viooxx prescriptions and is seeking additional civil penalties of up to $10,000 per violation of the law.

Meanwhile, the Associated Press recently reported that partial payments were being initiated to those people who claim that taking Vioxx caused them to suffer heart attacks as part of the $4.85 billion settlement between drug maker Merck & Co. and plaintiffs' lawyers. This payment mailing comprises about 40 percent of each plaintiff’s estimated total payout; it remains unclear how many plaintiffs will be receiving payments in this initial batch. The settlement is meant to end the majority of the personal injury lawsuits filed against Merck last November. Three years prior, Merck pulled Vioxx after its research confirmed Vioxx doubled the risk of heart attack and stroke.

The amount of eligible, registered claimants is now at 49,954, which comprises over 97 percent of claimants eligible for the settlement. This eligible pool is well above the threshold levels required for the deal to proceed. According to the AP report, Merck waived its right to walk away from the settlement on August 4 and deposited $500 million in one escrow account and gave claims administrators a letter of credit worth up to $4.1 billion to cover payments to claimants.

Former Drug Marketer Warns Consumers About New Drugs

Fri, 19 Sep 2008 00:00:00 -0700

Tom Nesi, a former insider in the world of big pharmaceuticals, has just written a new book entitled ¬Poison Pills: The Untold Story of the Vioxx Drug Scandal. Nesi hopes to expose what happens when consumers take newly approved, heavily marketed prescription medications.

Nesi, a former long-time director of public affairs at pharmaceutical giant Bristol-Myers Squibb, boasts over 30 years' experience in medical communications and strategy. Today, Nesi is a writer and consultant, with his latest book discussing the Vioxx scandal. Vioxx is the prescription painkiller that was pulled from the market after doctors realized too late it caused sometimes-fatal heart, blood, and kidney problems. Nesi says his overarching goal is to better enable consumers to utilize good medicines and avoid the harm that others can cause.

For example, Nesi explains that free samples are often the most expensive, citing Merck’s distribution of 17 million samples to 25,000 physicians and 375,000 patients. “The problem is that if you've been doing fine on a 20-cent pill, you get the free sample for a month or two, then you have to go to the drugstore to fill the prescription and then it costs you $3 a pill,” says Nesi. Nesi also points out that, “as extensively as a drug is tested before it's approved [by the Food and Drug Administration], it's still tested on a very small population. It's also tested on a very select population. Drug companies don't go out to try to find the sickest patients to test their drugs on.” Nesi explains there is more usage data with older drugs. “I don't think it hurts to wait a few years. I would say, if you're satisfied with your current therapy, stay with it,” Nesi adds.

Nesi’s book is a response to his wife’s death six years ago from cancer. After looking at experimental drugs, Nesi felt that “it was bogus,” saying he reevaluated his life’s work. “We're being duped,” he says, adding that he “didn't want to get out there anymore and tell people such-and-such a drug was a miracle compound when I knew that, (a) it wasn't, and (b) even if it was helping people, it was destroying their quality of life.” Today, Nesi urges consumers to “ask their doctors for proof that new drugs are superior to older ones before accepting a prescription for the newer medicine,” pointing out that “the larger the marketing campaign, the more you should use caution.” Due to concerns over reproductive health, Nesi cautions women, in particular.

Nesi notes switching—doctors recommending patients stop a successful prescription to begin a newer drug—happens “all the time,” citing “huge campaigns” and pointing to “Prilosec, for heartburn,” saying, “AstraZeneca, the company that had the patent, wanted to keep making money after Prilosec went off [patent], so they came up with a successor drug called Nexium, which is ‘the little purple pill.’ I remember working with a colleague … who was just astounded and said, ‘Nexium doesn't work any better.’"

Vioxx Investor Lawsuit Reinstated

Wed, 10 Sep 2008 00:00:00 -0700

Merck & Co. investors can sue the drug maker for losses they sustained when Vioxx was taken off the market because of safety problems, a federal appeals court has ruled. The class action Vioxx securities fraud lawsuit, which was brought on behalf of investors, was originally dismissed by a federal judge in Newark, N.J in April 2007.

Merck removed the Vioxx from the market in 2004 after a Food & Drug Administration (FDA) study estimated that Vioxx could have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. The Vioxx recall spawned thousands of product liability lawsuits. Earlier this year, Merck agreed to settle most of those Vioxx claims for $4.85 billion. However, investor lawsuits were not included in that settlement deal.

Merck shares plunged 27% -- a loss of about $30 billion for investors -- on the day of the Vioxx withdrawal and fell further in the ensuing months. Investors allege that, prior to the recall, Merck failed to disclose the risks posed by the painkiller.

U.S. District Judge Stanley R. Chesler had dismissed the lawsuit last year, ruling that all the plaintiffs' claims were time-barred under the statute of limitation. But a three-judge panel from the 3rd Circuit Court of Appeals voted 2-1 to reinstate the lawsuit. In a 49-page ruling, the two judges who voted to reinstate the suit ruled that the plaintiffs filed within the legal time limit to do so because even when there were early signs of trouble with Vioxx, Merck was still reassuring investors about its safety.

Merck said in a statement it had presented the judicial panel with alternative grounds for dismissal, but they were not considered. According to the statement, those grounds included arguments that the company could not have misstated Vioxx safety information because there was no strong data at the time linking the drug to heart attacks or stroke. Merck also said that information that the plaintiffs claim was omitted or misstated was disclosed in public documents or widely debated in public.

Merck said it is considering an appeal of the ruling. If the company chooses to follow that course, it could ask either the full Court of Appeals or the U.S. Supreme Court to review panel's decision.

Daily Ibuprofen Ups Heart Attack, Stroke Chances

Fri, 05 Sep 2008 00:00:00 -0700

Taking ibuprofen daily to relieve arthritis pain could put some older people at a higher risk of heart problems, including heart attack and stroke, a new study has found. The researchers conducting the study found that ibuprofen was the only painkiller, other than Vioxx, that increased this risk.

The painkiller study was conducted by scientists at Brigham and Women's Hospital in Boston, and published in the journal Arthritis Care & Research. The research team studied the medical records of female patients from two databases of Medicare recipients enrolled in drug benefit programs between 1999 and 2004. The average age of the patients in the study was 80.

According to Reuters, they identified 76,000 new users of COX-2 inhibitors, prescription drugs that include Vioxx, Pfizer's Celebrex, and others. They also found 53,000 new users of NSAIDs - a class of over-the-counter drugs - that includes aspirin, ibuprofen, naproxen and other over-the-counter pain relievers.

Vioxx users had the highest rates of heart attack, congestive heart failure and stroke, and naproxen users had the lowest, they found. Among patients who had survived at least one heart attack, Vioxx users had 9.4 more serious heart events per 100 people per year, and ibuprofen users 11.4 more such events, compared to nonusers.

Although the study only looked at white women in their 80s, the researchers said that doctors could use it as a guide when prescribing daily medications for treating arthritis pain.

The Food & Drug Administration (FDA) now requires all COX-2 inhibitors and NSAIDs to bear a black box warning regarding heart attack and stroke risks. The warnings were added to the drugs after Vioxx was recalled in 2004.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. But the FDA ordered Vioxx off the market in 2004 after studies showed that people who took the drug had a higher risk for heart attack. The recall came after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Since then, Vioxx the subject of thousands of drug injury law suits.

Late last year, Merck announced that it would a $4.85 billion settlement with Vioxx plaintiffs. Under the terms of the Vioxx settlement, Merck set up $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. Initial payments for the Vioxx settlement started going out to some plaintiffs last month.

Vioxx Payouts to Begin This Month

Thu, 21 Aug 2008 00:00:00 -0700

Partial settlement payments will soon be in the mail to those people who claim that taking Vioxx caused them to suffer heart attacks, the Associated Press is reporting. Vioxx is the pain reliever that was linked to heart failure and has since been removed from the market. Payments are scheduled to begin being sent on August 28 as part of the $4.85 billion settlement between drug maker Merck & Co. and plaintiffs' lawyers.

This payment mailing comprises about 40 percent of each plaintiff’s estimated total payout; it remains unclear how many plaintiffs will be receiving payments in this initial batch. The settlement is meant to end the majority of the personal injury lawsuits filed against Merck last November. Three years prior, Merck pulled Vioxx after its research confirmed Vioxx doubled the risk of heart attack and stroke.

The amount of eligible, registered claimants is now at 49,954, which comprises over 97 percent of claimants eligible for the settlement. This eligible pool is well above the threshold levels required for the deal to proceed. According to the AP report, Merck waived its right to walk away from the settlement on August 4 and, over the next two days, deposited $500 million in one escrow account and gave claims administrators a letter of credit worth up to $4.1 billion to cover payments to claimants.

Claims administrator BrownGreer PLC is now is reviewing millions of pages of documents submitted by claimants, electronically or on paper, for accuracy and to ensure no documents, especially those releasing Merck from future legal liability, are missing or incomplete. BrownGreer also said 44,680 claimants have submitted at least some of the required materials; those individuals who are missing items are being notified. Also, 3,441 claimants are at the point in which administrators are determining how many points they receive toward a settlement amount, which is determined by a complex formula that takes into consideration the severity of a claimant’s injury, how much Vioxx was taken, and how many health risk factors the person had. "Our projected value of each point (is) in excess of $1,900," according to a BrownGreer representative who added that "it is unprecedented that claims can begin going out in an eight-month period" since the settlement process began.

Settlement amounts can run from $5,000 to a couple of million dollars, the federal government is arranging to be reimbursed for care provided to Vioxx users under the Medicare and Medicaid programs. Also, private insurers are seeking reimbursement and Merck still faces about 260 potential class-action suits, alleging either harm or financial losses related to Vioxx. In addition, two cases have been certified as class action cases in Canada.

The Vioxx case has cost Merck at least $7 billion, including over $1.74 billion through last month on legal costs for defense research and individual trials.

The four-year legal debacle initiated when Merck pulled Vioxx off the market, which prompted tens of thousands of lawsuits. The Vioxx problems adversely affected Merck's previously exemplary reputation and forced out its then-chief executive.

Another Deceptive Vioxx Study Detailed

Tue, 19 Aug 2008 00:00:00 -0700

A Vioxx study that was supposedly meant to find out if the recalled painkiller was less likely to cause stomach problems than another drug was really nothing more than a marketing ploy, a new report says. According to Merck & Co. memos and reports obtained during Vioxx lawsuits, the Advantage study was crafted by Merck's marketing department to get physicians to prescribe Vioxx. What's worse, when the study was published, it omitted information about patients who had suffered cardiovascular problems while enrolled in the trial.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The Vioxx recall led to thousands of lawsuits.

The report on the Advantage study was compiled by researchers working as paid consultant for lawyers who were suing Merck for Vioxx injuries. The Advantage study compared Vioxx to naproxen when given to patients already taking aspirin. The purpose of enlisting nearly 600 doctors in the Advantage study was to boost their confidence in the new drug and get them to promote it to colleagues, the report said.

According to internal Merck documents, the Advantage study was called a "seeding trial". The Merck marketing executives who were in charge of the study were nominated for the company's ``Best Physician Program Award.'' According to the award memo, the executives were nominated because the physicians who participated in the study prescribed Vioxx much more often than other doctors.

The original Advantage study was published in the Annals of Internal Medicine in 2003. A later analysis found several patients suffered cardiovascular complications that weren't reported in the original trial. That omission makes the study even more disturbing.

According to the authors of the Vioxx Advantage report, using seeding trials to market drugs is not an unusual practice. But such a trial is a ``moral offense,'' the authors wrote, because there is no way for people outside of the drug company to know the study's true intent.

This is not the first time Vioxx trials run by Merck have raised serious ethical questions. In April, it was learned that Merck concealed mortality risks in two key Vioxx studies, and hired “ghostwriters” to author research that was supposedly conducted by independent scientists. According to articles that appeared in the April issue of the "Journal of the American Medical Association", an analysis of court documents uncovered in the course of Vioxx injury lawsuits found that Merck employees worked alone or with publishing companies to write study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. In many cases, Merck’s involvement in producing the data wasn’t disclosed.

Merck also used its control over Vioxx studies to manipulate the data so that it favored the now-recalled drug. One of the JAMA articles says that in 2001, Merck had data that Vioxx patients in two Alzheimer’s studies had a higher death rate than patients on dummy pills. Merck didn’t publicize that “in a timely fashion” and provided information to the FDA that downplayed the deaths, the report said.

Study Confirms Vioxx and Bextra Dangers

Fri, 08 Aug 2008 00:00:00 -0700

Another study has confirmed that Vioxx and Bextra increase the risk of having a stroke. Both Bextra and Vioxx were removed from the market because of their association with heart attacks and stroke.

This latest study, which looked at the stroke risk of COX2 inhibitors like Vioxx and Bextra, as well as the risk of other NSAIDs like ibuprofen, was conducted by researchers at Vanderbilt University in Tennessee. The study focused on the seven most common NSAIDs, including Celebrex, Vioxx, Bextra, ibuprofen, naproxen, indomethacin, and diclofenac.

Among the participants, 78,036 were current users of one of the seven study NSAIDs, 16,420 were current users of other NSAIDs or NSAID combinations, and 242,450 were nonusers.

The study found that the risk of stroke was 28 percent higher among Vioxx users and 41 percent higher among Bextra users. The risk of stroke was not significantly increased with Celebrex or with other NSAIDs

In an interview with Reuters news service, lead researcher Dr. Christianne Roumie said the decisions to take Vioxx and Bextra off the market were justified. "This study suggests that rofecoxib (Vioxx) and valdecoxib (Bextra) were associated with higher stoke risk than other NSAIDs," Roumie said in the interview.

"Because of this and other studies, their withdrawal from the market is appropriate and these medications should not be re-introduced, especially since safer alternatives are available," she explained.

Bextra, made by Pfizer, was removed from the market in 2005. In May, The Wall Street Journal reported that Pfizer had reached settlements with three law firms representing patients who sued over the drug. Pfizer was reportedly offering such patients as much as $200,000 to settle their Bextra cases.

Vioxx was recalled in 2004. Last November, Merck announced a $4.85 billion settlement with the thousands of people who had filed Vioxx injury lawsuits. Under the terms of the settlement, Merck set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. Partial settlement payments are expected to start going out this month.

FDA Introduces New Conflict of Interest Rules

Wed, 06 Aug 2008 00:00:00 -0700

The Food & Drug Administration (FDA) has finally taken steps to address potential conflicts of interests among members of its advisory panels. What remains to be seen is whether the FDA's new policies will effectively put an end to possible conflicts of interests caused by the financial ties advisers often have to the drug industry.

Advisory panel members are experts who advise the FDA on matters such as drug approvals and labeling changes. Recent scandals surrounding the misguided approvals of drugs like Vioxx have raised questions about the FDA advisers and the financial ties - such as a grant from the drug company seeking approval of a new medicine - some of them have to the drug industry.

In 2006, the consumer advocacy group Public Citizen published a study which found that at least one advisory panel member had a financial relationship with a drug company in 73 percent of the FDA advisory committee meetings held from 2001 to 2004. Some of the voting members' grants or consulting fees exceeded $100,000.

Critics of these financial arrangements argue that they could potentially influence the way an advisory panel member votes. Reacting to both congressional and public pressure, the FDA has issued four final guidance documents designed to limit bias on the committees and open their procedures to public examination.

Under the new rules, FDA advisers with a financial stake of more than $50,000 in all companies that could be affected by the outcome of an panel vote will, in most cases, not be allowed to participate. Advisers with stock, grants or other financial interests amounting to less than $50,000 may be allowed to attend meetings and vote if their expertise is deemed essential, and if the FDA grants a waiver. The reason for the waiver, and the expert's personal financial stake would be posted on the FDA's Web site before the meeting.

Advisers would not be able to participate on a panel under certain conditions even if their financial stake did not reach $50,000. Experts would be ruled out, for example, if they served as principal investigators on a clinical trial of a product their committee was considering for approval. They would also be disqualified if they led a clinical trial on a competing product.

Many FDA critics say the new rules don't go far enough to insure that all conflicts of interest are avoided. Dr. Sidney Wolfe, director of Public Citizen health research group, told the San Francisco Chronicle that the new rules are weaker than the draft guidelines FDA released for discussion more than a year ago. Under those proposals, experts with conflicts of up to $50,000 would have been permitted to attend committee meetings, but not to vote.

Merck's Vioxx Payouts to Begin in August

Fri, 18 Jul 2008 00:00:00 -0700

New Jersey-based Merck & Company will begin funding $4.85 billion to resolve state and federal claims over its painkiller Vioxx. The first payment of $500 million is scheduled for August 6; additional payments will follow. Merck said it met its threshold to make these payouts and waived its right to walk away from last November’s agreement to settle roughly 50,000 lawsuits.

After years of litigation, a comprehensive settlement was proposed in November under which Merck agreed to compensate plaintiffs who can show, under certain conditions, that taking Vioxx is connected to their having suffered a heart attack or stroke. More than 48,500 of about 50,000 people—about 97 percent of all eligible claimants—registered, exceeding the 85 percent required threshold. In addition, Merck extended the enrollment deadline to October 30, 2008 for eligible plaintiffs. According to the Associated Press, “payouts are expected at a minimum of $5,000 up to a few million dollars” to “former Vioxx users, or their survivors.” To be eligible, “They must have had pending lawsuits or tolling agreements, which suspend the statute of limitations, as of November 9, 2007, the date the settlement was reached.”

Merck pulled Vioxx from the market on September 30, 2004 after its study showed that long-term Vioxx users had twice the risk of heart attack and stroke. Merck also agreed to a $58 million settlement with Washington, the District of Columbia and 28 other states in May over deceptive marketing of Vioxx. In April, two reports published in the Journal of the American Medical Association (JAMA) found that two Merck-funded studies investigating the benefits of Vioxx in Alzheimer’s minimized death rates. The reports also revealed that Merck hired outside firms to write Vioxx studies, paying prominent researchers to list their names as research authors.

A consent judgment against Merck, filed in Suffolk Superior Court, prevents the New Jersey-based drug maker from misleading consumers in future advertising and mandates full disclosure of all known risks of Merck drugs. The judgment bans the deceptive use of scientific data when marketing doctors and “ghost writing” articles and studies and addresses conflict of interest issues. Also, Merck must obtain Food & Drug Administration (FDA) approval for direct to consumer television drug advertisements and must comply with regulatory recommendations if the FDA calls for a delay in such advertising. In 2000, Merck spent $160.8 million on direct to consumer Vioxx marketing.

Vioxx—refecoxib—is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) and works by reducing substances that cause inflammation, pain, and fever. A three-year study aimed at showing that Vioxx—at a 25-milligram dose—prevents recurrence of polyps in the colon and rectum was ceased when Merck discovered a higher heart risk compared to patients taking placebos. Prior to the Vioxx withdrawal, the FDA announced that patients taking Vioxx had a 50 percent greater chance of heart attack and sudden cardiac death and patients taking the highest recommended daily dosage of Vioxx had three times the risk of heart attack and sudden cardiac death as those not taking standard painkillers.

Drug Makers Decry FDA Safety Push

Tue, 01 Jul 2008 00:00:00 -0700

Drug makers are complaining that the Food & Drug Administration (FDA) is too focused on, of all things, safety. The pharmaceutical industry says the FDA' s tougher stance is slowing the arrival of new drugs to the market, but consumer advocates - citing recent scandals involving defective drugs - say a stronger focus on safety is long overdue.

According to the Wall Street Journal, the FDA approved just 19 new medicines last year, the fewest in 24 years, and announced about 75 new or revised "black-box" warnings about potential side effects -- the agency's strongest -- twice the number in 2004. The number of so-called approvable letters, which typically postpone FDA approval decisions pending more data, increased by 40% last year.

Drug makers are less-than-enthusiastic about the FDA's new approach. Schering-Plough Corp. Chief Executive Fred Hassan told The Wall Street Journal that the new safety focus means that drug companies must now spend significantly more time and money to get a drug approved - and even then, approval is not guaranteed. "What will it take to get new drugs approved?" Hassan said. "The point is, we don't know."

The FDA's new caution can be traced to the Vioxx debacle. Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The FDA ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

Shortly after Vioxx was pulled from the market, it was revealed the FDA had tried to silence the drug expert who headed that analysis. Dr. David Graham, associate director for science in the FDA Drug Center’s Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.

Following the Vioxx mess, several other drug safety scandals intensified pressure on the agency. For instance, after a study was published last May detailing heart risks with the diabetes drug Avandia, it was revealed that in 2005 GlaxoSmithKline had informed the FDA of a study it had conducted that produced similar results. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues.

And just this year, it was learned that the makers of Vytorin withheld a study that found the expensive cholesterol medication was no more effective than cheaper statins for two years. Poor FDA oversight of foreign drug plants allowed tainted heparin to kill at least 149 people this year, and the agency has been slow to take strong action against the stop-smoking drug Chantix, which has been linked to suicides.

These and other scandals have strained the credibility of both the FDA and the pharmaceutical industry. The FDA has apparently heard the criticism. In addition to being tougher on new drug approvals, the agency is adding warnings about cancer risk to arthritis drugs for children, and warnings about suicide risk to epilepsy drugs. The FDA is also considering instituting tougher approval criteria for diabetes drugs.

None of this sets well with the pharmaceutical industry, which relies on new drug approvals to stay in the black. But considering the industry's recent history of manipulating clinical data, concealing dangerous side effects and aggressively promoting risky products, drug makers have only themselves to blame.

Vioxx Settlement Deadlines Loom

Mon, 30 Jun 2008 00:00:00 -0700

A little over 59,000 people have registered for the Vioxx settlement, and plaintiffs who submitted paperwork early could start seeing initial payments soon. Meanwhile, two big Vioxx settlement deadlines are on the calendar for next week.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

Last November, Merck announced a $4.85 billion settlement with the thousands of people who had filed Vioxx injury lawsuits. Under the terms of the settlement, Merck will set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. The settlements will be awarded on an individual bases, and the amount of money each plaintiff ultimately receives will vary.

By Monday, people who have registered for the Vioxx settlement must file a required set of legal papers. So far, a little over 51,000 claimants have turned in that paperwork.

Tuesday is the deadline for submitting medical and pharmacy records to back up claims. However, extensions are built into from July 1 to Sept. 1 to Nov. 1 and Nov. 30, as it could take plaintiffs some time to assemble all of those records.

Merck Gets Another Vioxx Win

Fri, 06 Jun 2008 00:00:00 -0700

Merck & Co. was on the winning end of another Vioxx court decision this week, the third favorable ruling involving the deadly painkiller in the past month. This time, the New Jersey Supreme Court voted 5-1 that Vioxx users who had not shown signs of an injury are not entitled to medical monitoring paid for by Merck. The ruling effectively dismisses a class action lawsuit filed by former Vioxx users seeking to have Merck cover diagnostic testing that might uncover undetected Vioxx injuries.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. But in 2004, the Food & Drug Administration (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The Vioxx recall led to thousands of lawsuits against Merck.

On Wednesday, the New Jersey high court ruled that since the Vioxx users involved in the class action lawsuit were not claiming injury, they "cannot satisfy the definition of harm" in seeking medical monitoring under the state's Product Liability Act.

One justice disagreed with the majority. In her dissent, Justice Virginia A. Long wrote that that the New Jersey Products Liability Act recognized that "increased risk of injury that creates a need for medical surveillance" is a recognizable harm.

It has been a good couple of weeks for Merck, which has now racked up three Vioxx victories since the end of May. In another New Jersey case, the Superior Court's Appellate Division reduced a Vioxx jury award by $13 million when it ruled that the plaintiff in the case was not entitled to punitive damages, and that the jury should not have been allowed to find Merck guilty of consumer fraud. The appeals court did, however, allow the jury's $4.5 million compensatory damage award to stand.

That same week, a Texas appeals court overturned a $26 million jury verdict against Merck in a lawsuit brought by a woman whose husband died in 2001 after taking Vioxx. In reversing the verdict, the appeals court found that plaintiff had not proved that Vioxx caused the man’s death. In doing so, the three appeals court judges reversed the verdict of a jury, throwing out the views of the plaintiff’s experts.

Despite these victories, Merck's multi-billion dollar proposed Vioxx settlement announced in November is still on track. The $4.85 billion settlement covers about 50,000 people who have sued Merck claiming that they or their family members had heart attacks or strokes after taking Vioxx. Plaintiffs face a June 30 deadline to agree to the settlement, which will result in an average payment of roughly $100,000 a plaintiff before legal fees, or to opt out and continue their lawsuits. Merck has said that 95 percent of eligible plaintiffs had agreed to the deal and that the company was nearly certain it will go forward.

Merck Gets Two Vioxx Victories, But Settlement Still on Track

Fri, 30 May 2008 00:00:00 -0700

Vioxx maker Merck & Co. won two court victories this week, in Texas and New Jersey, as appeals courts reversed rulings in Vioxx lawsuits. However, the Merck victories won't affect the $4.85 billion settlement the company struck with thousands of Vioxx victims last November.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

In Texas, a state appeals court overturned a $26 million jury verdict against Merck in a lawsuit brought by Carol Ernst, whose husband, Robert, died in 2001 after taking Vioxx. In reversing the verdict, the appeals court found that plaintiffs had not proved that Vioxx cause the man's death. In doing so, the three appeals court judges reversed the verdict of a jury, throwing out the views of the plaintiffs’ experts.

In New Jersey, an appeals court reduced a verdict in another Vioxx case. The court ruled that the jury should not have been allowed to award punitive damages against Merck or to find that Merck had committed consumer fraud. Only compensatory damages of $4.5 million were permitted.

The rulings brought immediate criticism from plaintiffs' lawyers involved in the Vioxx case, as well as promises to appeal. One of the attorneys characterized the Texas ruling as "judicial activism for corporate America," and said the opinion of the panel in the Texas case was " "cursory" and "seems to construe the evidence in favor of the defendant and leaves out all of the evidence that supports the verdict."

However, lawyers involved in the New Jersey Vioxx lawsuit were pleased that the court there let the damage award stand. They noted that this is the first time an appeals court has ruled that federal statutes and rules do not pre-empt claims brought under a state products liability law for a FDA-approved drug that further research shows may have dangerous side effects.

Recently, drug and device makers have claimed that FDA approval bars state lawsuits against defective medications and medical devices. Recently, the US Supreme Court ruled in favor medical device makers in a pre-emption case involving Medtronic Inc., and the court is set to consider pre-emption for drug makers next fall.

The rulings will not affect the multi-billion settlement Merck offered Vioxx plaintiffs in November. The settlement covers about 50,000 people who have sued Merck claiming that they or their family members had heart attacks or strokes after taking Vioxx. Plaintiffs face a June 30 deadline to agree to the settlement, which will result in an average payment of roughly $100,000 a plaintiff before legal fees, or to opt out and continue their lawsuits. Merck has said that 95 percent of eligible plaintiffs had agreed to the deal and that the company was nearly certain it will go forward.

Merck To Pay $58 Million in Vioxx Settlement

Wed, 21 May 2008 00:00:00 -0700

Drug maker Merck & Co. Inc., will pay $58 million to Massachusetts, 28 other states, and the District of Columbia, to settle lawsuits that claim Merck allegedly used deceptive marketing to promote its popular painkiller Vioxx. Merck employs over 150 people at a research facility in Boston's Longwood area.

Vioxx is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) and works by reducing substances that cause inflammation, pain, and fever. A three-year study aimed at showing that Vioxx—at a 25 milligram dose—prevents recurrence of polyps in the colon and rectum was ceased when Merck discovered a higher heart risk compared to patients taking placebos. Prior to the Vioxx withdrawal, the Food and Drug Administration (FDA) announced that patients taking Vioxx had a 50 percent greater chance of heart attack and sudden cardiac death and patients taking the highest recommended daily dosage of Vioxx had three times the risk of heart attack and sudden cardiac death as those not taking standard painkillers. Merck pulled Vioxx from the market on September 30, 2004 after acknowledging that Vioxx could significantly increase the risk of heart attacks.

After a few years of litigation, a comprehensive settlement was proposed in November. Under the settlement plan, Merck agreed to compensate plaintiffs who can show, under certain conditions, that taking the drug was connected to their having suffered a heart attack or stroke.

Massachusetts Attorney General Martha Coakley called the settlement the "largest consumer protection settlement to date" regarding the promotion of a prescription drug. Coakley said under the settlement, Massachusetts will receive $1.64 million of the overall payment. Of that amount, $500,000 goes to the Attorney General's Local Consumer Aid Fund and $1 million goes into a fund to help low-income, disabled, or elderly consumers who take prescription drugs or to educate consumers about drug price differences. The remainder pays for legal costs and attorneys fees.

The consent judgment against Merck, filed in Suffolk Superior Court, prevents New Jersey-based Merck from misleading consumers in future advertising and mandates full disclosure of all known risks of Merck drugs. The judgment bans the deceptive use of scientific data when marketing doctors and "ghost writing" articles and studies and addresses conflict of interest issues. Also, Merck must obtain FDA approval for direct to consumer television drug advertisements and must comply with regulatory recommendations if the FDA calls for a delay in such advertising. In 2000, Merck spent $160.8 million on direct to consumer Vioxx marketing.

In a statement released by Merck, its general counsel said Merck "remains committed to communications that help patients and their physicians choose medicines based on accurate, fair, and balanced information. Today's agreement enables Merck to put this matter behind us and focus on what Merck does best, developing new medicines."

In April, two reports published in the Journal of the American Medical Association (JAMA) found that two Merck-funded studies investigating the benefits of Vioxx for Alzheimer's disease patients had minimized death rates for people taking the now-recalled drug. The reports also revealed that Merck hired outside firms to write Vioxx studies, paying prominent researchers to list their names as authors of the research.

Pfizer Negotiating Celebrex, Bextra Settlements

Mon, 05 May 2008 00:00:00 -0700

Celebrex and Bextra maker Pfizer Inc. has begun to settle injury claims against the painkillers. It is estimated that between 7,000 and 9,000 Celebrex and Bextra cases have been filed by people who claim the defective painkillers caused heart attacks and strokes. According to a report in Friday's Wall Street Journal, lawyers representing Pfizer have indicated the company is willing to pay as much as $500 million to resolve all outstanding cases.

Celebrex and Bextra are COX-2 inhibitors, a class of drugs that also includes Merck's recalled Vioxx. Such medications are linked to an increased risk of blood clots, heart attacks and strokes. Pfizer withdrew Bextra from the market in 2005, and Celebrex is the only COX-2 inhibitor still on the market in the United States.

According to The Wall Street Journal, Pfizer has reached settlements with three law firms representing more than 200 of the thousands who sued over the drugs. Firms have been offered $40,000 to $50,000 a client to resolve Celebrex cases and as much as $200,000 a client for Bextra. The Wall Street Journal reported that unlike Merck's recent mass settlement of litigation involving Vioxx, Pfizer is attempting to resolve its Bextra and Celebrex lawsuits on a firm-by-firm basis.

Celebrex carries the Food and Drug Administration’s strictest “black-box” warning on its drug label, stating that it may cause an increased risk of serious cardiovascular events such as heart attacks and strokes. Despite its apparent risk, Celebrex continued to generate $2.3 billion in sales in 2007, a 12 percent increase from the previous year.

Last month, the National Cancer Institute released an analysis of six Celebrex studies that included 7,950 patients. According to The Wall Street Journal, the analysis showed Celebrex was associated with an increased risk of cardiovascular death, heart attack, stroke, heart failure or thromboembolic event, or events related to blood clots, compared to patients not taking the drug. The researchers found that patients receiving the highest dose of Celebrex of 400 milligrams twice daily had a nearly three times higher risk of heart attacks and strokes than patients not taking the drug. Patients taking a lower dose of Celebrex, 400 milligrams once daily, had a 10% higher risk of a cardiovascular event. The study did not look at patients taking a once-daily, 200-milligram dose of Celebrex, which represents the way the drug is most commonly prescribed.

The first Bextra trial was due to begin today in federal court in San Francisco. But a lawyer involved in the case told The Wall Street Journal that the parties agreed to adjourn the case so Pfizer could attempt to settle Celebrex and Bextra cases across the country.

Merck Extends Another Vioxx Settlement Deadline

Mon, 05 May 2008 00:00:00 -0700

Merck just extended the deadline for registered participants to submit paperwork to June 30 on the Vioxx program. Merck states that the proposed $4.85 billion settlement for illness associated with Vioxx—also known as refecoxib—continues on schedule. The original deadline for claimants to provide documents proving they took Vioxx and then had a heart attack or stroke was May 1; the registration deadline was January 15.

"The resolution program is going forward in a satisfactory way. We expect to meet and exceed the threshold for funding of the program," said Merck & Co. spokesman Kent Jarrell. Lawyers on the plaintiffs' steering committee said the extension raised no concerns, adding it was anticipated because the claims administrator continues to verify submitted documents. "The enrollment has been overwhelming and the documents have been coming in at a great pace," said one of those lawyers.

Merck added that unverified claims are now at nearly 95 percent of eligible plaintiffs in all categories. Once 85 percent of eligible plaintiffs registered, Merck was obligated to participate in the settlement. The deal was reached in November in an effort to end most of the 61,100 Vioxx lawsuits. Approximately 45,000 eligible claimants initiated enrollment by March 31, according to Merck which enabled settlement activities moving forward.

Vioxx is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) and works by reducing substances that cause inflammation, pain, and fever. Merck pulled Vioxx from the market on September 30, 2004, following mounting evidence that Vioxx doubled patient risk of heart attack and stroke. After a few years of litigation, a comprehensive settlement was proposed in November. Under the settlement plan, Merck agreed to compensate plaintiffs who can show, under certain conditions, that taking the drug was connected their having suffered a heart attack or stroke.

As of March, Merck reported that the majority of claimants who registered injuries eligible for compensation have submitted some or all of the documentation required to seek a share of the settlement. Claimants are now required to provide medical records that third-party administrators will use to assess for what payment they might qualify. Under the plan, a claim must be based on an incidence of heart attack, ischemic stroke, or sudden cardiac death. Plaintiffs must provide documentation indicating Vioxx was taken for at least 30 days and the injury occurred within 14 days of using the drug. Payouts will be adjusted according to other cardiovascular risk factors.

Plaintiffs lawyers estimate that, depending on age and risk factors, settlement payments will range from $50,000 to $1.5 million, with an average exceeding $200,000. Merck set aside $1.9 billion for litigation costs—not including payouts—and spent $1.2 billion. Plaintiffs had trouble persuading juries that Vioxx, and not other risk factors, caused injuries. Of the 16 cases that went to trial, Merck won 11; however, at the first Vioxx trial, a jury in August 2005 awarded a Texas widow $253.4 million—later reduced to $27.2 million, including interest. Also, Merck agreed to remove a $600,000 cap on supplementary payments to individual claimants able to prove "extraordinary injury.”

Merck Vioxx Study Scandal Fans Opposition to Proposed FDA Rule Changes

Mon, 21 Apr 2008 00:00:00 -0700

Last week's revelation that Merck Inc. manipulated two Vioxx studies in order to downplay death rates has prompted more criticism of a Food & Drug Administration (FDA) plan to loosen off-label marketing rules that drug makers must adhere to. If approved, the proposed FDA rule change would allow drug and medical device makers to provide doctors with copies of medical journal articles that discuss off-label uses of their products.

Off-label use is the use of a drug or medical device for a purpose not approved by the FDA. For example, gadolinium contrast dyes are often used off-label in MRA (Magnetic Resonance Angiography) procedures, even though such agents are only approved for use in MRI procedures. Once a drug or medical device has been approved by the FDA, doctors are free to prescribe it as they see fit. In fact, a 2006 study estimated that more than 20 percent of all prescriptions written by doctors were for unapproved uses. However, drug and medical device companies are prohibited from advertising off-label uses. In 1997, Congress created a temporary exception to the off-label marketing rule by allowing drug makers and medical device companies to distribute reprints of peer-reviewed research from reputable medical journals that discussed off-label uses to physicians. Drug makers and medical device manufacturers were able to do so long as they submitted the articles to the FDA for advance review and had formally asked the FDA to approve the new use described in the journal article. That exception expired in 2006.

The FDA wants to renew the exception, with some very big changes. Under the proposed rule, the agency would let drug and device companies pass out articles to doctors if the articles were peer-reviewed and came from a journal with an expert editorial board. The article must be accompanied by a prominent warning that the use described is not approved or cleared by the FDA. However, the FDA wants to drop the requirement that drug and device makers must provide the studies to the FDA beforehand or promise to seek approval of the discussed use. According to The New York Times, the FDA has justified this proposed loosening of the rules by claiming it never really enforced those requirements anyway.

The proposed change has raised the ire of many law makers and consumer advocates. They point out that drug and medical device makers have long flouted the rules governing off-label marketing, often to the detriment of consumers. Last week, Merck only added fuel to the fire, when two reports published in the Journal of the American Medical Association (JAMA) found that two Merck-funded studies investigating the benefits of Vioxx for Alzheimer's disease patients had actually down played death rates for people taking the now-recalled drug. The reports also revealed that Merck also hired outside firms to write Vioxx studies, and then paid prominent researches to list their names as authors of the research. The JAMA reports also indicated such practices were widespread within the pharmaceutical industry.

The Vioxx report has raised new questions about the validity of many published research studies, even in peer-reviewed publications. The lead author of the JAMA article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in Manhattan, told The New York Times that his findings helped highlight flaws in the FDA. proposal’s reliance on peer-reviewed journals to provide the evidence supporting off-label drug use. “What does it mean to be peer-reviewed,” Dr. Ross said, “if the company has essentially conceived the article, composed the draft and written the paper?”

Groups including Public Citizen, New York State’s health commissioner and the Blue Cross Blue Shield Association, a trade association of 39 major health insurance plans, also oppose the FDA's plans. According to The New York Times, both the Blue Cross association’s vice president, Dr. Allan M. Korn, and New York State health commissioner, Dr. Richard F. Daines, have written the FDA, citing concerns of possible pharmaceutical industry manipulation of peer-reviewed journals and how those articles could be used to promote off-label uses.

In the past, drug makers have shown a willingness to flout off-label use rules. For instance, Pfizer Inc. settled a case about the epilepsy drug Neurontin in 2004 for $430 million. In another high-profile case, Eli Lilly is said to be in negotiations with the Justice Department over illegal marketing of Zyprexa. According to media reports, Eli Lilly could end up paying in excess of $1 billion to settle allegations it marketed Zyprexa for unapproved uses, including dementia, depression and autism.

The FDA has justified its off-label use proposal by claiming that the peer-review process used by major medical journals prevents drug companies from manipulating study data. But last weeks Merck revelations blew a huge hole in that theory. Whether or not the FDA will rethink its position remains to be seen.

Merck Not the Only Drug Company to Use "Ghostwriters"

Fri, 18 Apr 2008 00:00:00 -0700

Earlier this week, it was learned Merck & Company conducted research on Vioxx, and the concealed it role in the studies by paying prominent scientists to lend their names to them. Unfortunatel, this is not an uncommon practice.

"We've got to stop this," said Dr. Catherine D. DeAngelis, editor of the Journal of the American Medical Association (JAMA). "People are being hurt. We've given away our profession." This week, articles in JAMA say Merck not only conducted its own studies on the pain pill Vioxx, it alsohired a company to ghostwrite reports for medical journals which were stated as being written by scientists who did very little of the research. According to the articles, Merck did not disclose the use of ghostwriters. The only reason the manipulations surrounding the Vioxx studies are coming to light is because lawsuits filed on behalf of people injured by the defective drug forced Merck to release documents detailing the practices.

DeAngelis, a pediatrician who was vice dean for academic affairs at Johns Hopkins School of Medicine, said she was approached frequently to put her name on research she had not conducted. Sometimes, drug company representatives told her she would have very little work to do and could refer to a draft written by a professional writing firm. In an editorial, DeAngelis and deputy editor Phil. B. Fontanarosa wrote that the practices of ghostwriting and "guest authorship" point to how the medical profession has been "inundated with profound influence from the pharmaceutical and medical device industries."

Dr. Jean Sealey, retired Weill Cornell Medical College professor and noted hypertension authority, said a London-based consulting firm that helps drug companies publish research invited her to "author" an article for an American Society for Hypertension conference. The conference was just one week away and she had never heard of the drug.

Dr. Troyen Brennan, former director of the physicians' organization at Boston's Brigham and Women's Hospital, said a prominent public relations firm, Edelman Medical Communications, offered to pay him to write a piece on antihistamines and other drugs with sedative effects; the company planned on given having him use an editorial it commissioned for another journal.

Dr. Jerome Kassirer, editor of the New England Journal of Medicine (1991-1999), said companies that draft research articles on their own drugs "necessarily bias the article in favor of their products." Kassirer said that hiring consulting firms to write a first draft of review articles, in which a number of studies are collaborated, is very dangerous because the firm can pick and choose those studies that reflect favorably on the drug and omit those that do not; an author who writes the final draft may be unaware of the omissions.

Recent litigation involving the Ortho Evra birth control patch revealed documents indicating Johnson & Johnson hid information on Ortho Evra’s blood clot risk from the FDA. And the recent scandal surrounding tainted heparin shows the FDA is ill-equipped to police the safety of even the most routine medicines. When pharmaceutical and medical device makers manipulate and withhold clinical trials results and as the FDA continues to inadequately oversee safety, litigation is often the only way abuses such as Merck’s are ever made known.

FDA Considering Biomarkers As a Way to Improve Drug Safety

Thu, 17 Apr 2008 00:00:00 -0700

A new way of testing experimental drugs is being considered by the Food & Drug Administration (FDA). If adopted, the FDA could end up requiring "biomarker" tests for all new drugs. Proponents of the new biomarker process say it would help bring new drugs to market more quickly, while at the same time, reduce the risk that patients might be exposed to dangerous side effects that aren't apparent when new drugs are tested in animals. However, some patient advocates, while favoring the adoption of biomarker tests, say they will only be useful if drug makers take their results seriously. In the past, several high profile drugs - for example Avandia and Vytorin - showed signs of toxicity in animal tests. But those problems were ignored and the drugs proceeded to human clinical trials, and were eventually approved by the FDA.

A biomarker is an indicator that can be used to test a biological function. Some biomarkers turn up when organs are injured and cells within the damaged tissue release substances into the blood, urine or saliva. These substances can be used to detect dangerous side effects. Right now, the FDA is considering a testing process that uses seven indicators - known as biomarkers - that signal kidney injury when found in the urine of test subjects. Initially, the seven biomarker testing processes will be qualified by the FDA for use in preclinical animal studies, and only as a complement to current tests. But ultimately, the pharmaceutical industry would like to see the FDA adopt a range of such biomarker tests for human clinical trials that would signal dangerous side effects like heart failure, liver damage or cancer.

Under current testing protocols, experimental drugs are subjected to animal testing before they can move on to human clinical trials. But animal tests aren't always the best predictor of whether substances will be safe for humans. For example, if a drug toxic to the kidneys passes animal tests today, the damage might not show up until it is too late. Under a biomarker protocol, samples of blood, urine or saliva, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.

It is hoped that biomarkers will speed the development of new drugs. Over the past 10 years, the number of new drugs and therapies submitted for FDA approval dropped by 50 percent. The move towards biomarkers has also been spurred by safety scandals surrounding some drugs, such as Vioxx, which was found to put users at risk for heart attacks and strokes after it came on the market.

While many patient advocates agree that biomarkers could go a long way towards improving drug safety, they contend the process will only work if drug makers abide by results. And some are skeptical that this will always be the case. Dr. Sidney Wolf of the group Public Citizen told the "San Francisco Chronicle" that in the past, drug makers have ignored safety issues apparent in early testing of drugs. "Findings of toxicity in the currently required animal tests are not taken seriously enough by companies or by the FDA," Wolfe said. "Avandia showed evidence of heart damage in animal studies and, for Vytorin, tests showed serious toxicity in laboratory animals, regardless of how low a dose of this combination drug was used." Both drugs came under fire in the last year because of problems, and the companies that developed them have been accused of withholding or downplaying vital information on safety and effectiveness when they were submitted to the FDA for approval.

Unfortunately, it is not unusual for drug makers to use the control they have over drug clinical trials to downplay disturbing findings. Yesterday, two reports in the “Journal of the American Medical Association” (JAMA) found Merck Inc. concealed mortality risks in two key Vioxx studies, and hired “ghostwriters” to author research that was supposedly conducted by independent scientists. Such practices are used throughout the drug industry, though they are hard to document, the authors of the JAMA reports said. Considering this history, it is fair to question whether or not the pharmaceutical companies would attempt to manipulate biomarker tests in the same way.

Merck Deception in Vioxx Studies Detailed

Wed, 16 Apr 2008 00:00:00 -0700

Merck Inc. concealed mortality risks in two key Vioxx studies, and hired "ghostwriters" to author research that was supposedly conducted by independent scientists. These revelations - detailed in two reports published in the "Journal of the American Medical Association" (JAMA) - show the extent to which drug companies are able to manipulate clinical trial data. Such practices are used throughout the drug industry, though they are hard to document, the authors of the JAMA reports said. In fact, the only reason the manipulations surrounding the Vioxx studies are coming to light is because lawsuits filed on behalf of people injured by the defective drug forced Merck to release documents detailing the practices

This is not the first time drug makers have been accused of withholding vital safety information about their medications. Recent litigation involving the Ortho Evra birth control patch has revealed documents that indicate Johnson & Johnson hid information on Ortho Evra's blood clot risk from the Food & Drug Administration (FDA). And the recent scandal surrounding tainted heparin has proven that the FDA is ill-equipped to police the safety of even the most routine medicines.

Such drug safety scandals, taken together with today's Vioxx revelations, raise serious questions about attempts by the pharmaceutical and medical industries to convince courts that FDA approval of drugs preempts drug injury lawsuits in state courts. With pharmaceutical and medical device makers going to great lengths to manipulate and withhold results of clinical trials, and the FDA seemingly unable to adequately oversee safety, litigation is often the only way abuses such as Merck's are ever made known. Unfortunately, the US Supreme Court has already extended a lawsuit shield to device makers, and this fall it will hear a second pre-emption case involving the drug maker Wyeth. Many legal experts expect the court to rule in favor of drug companies.

Patient advocates, including Jerry Parker, Managing Partner at Parker Waichman Alonso LLP, a law firm that has represented thousands of people injured by defective drugs, says such a development would be a blow to patients. "Vioxx is just more reason – if we needed it after Ortho Evra - that the civil justice system plays an important role in policing the pharmaceutical and medical device companies," Parker said. "It is the role that the FDA was supposed to play but is unable to."

The conduct of Merck and the FDA had already come under a great deal of scrutiny because of the Vioxx debacle. In 2004, an FDA study estimated that Vioxx could have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. After Vioxx was pulled from the market in 2004, it was revealed that the FDA had tried to silence the drug expert who headed that study. Dr. David Graham, associate director for science in the FDA Drug Center’s Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.

Now, it seems that Merck was less than forthcoming about two studies involving Vioxx and Alzheimer's Disease patients. According to an analysis of court documents uncovered in the course of Vioxx injury lawsuits, Merck employees worked alone or with publishing companies to write study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. In many cases, Merck's involvement in producing the data wasn't disclosed.

Merck also used its control over Vioxx studies to manipulate the data so that it favored the now-recalled drug. One of the JAMA articles says that in 2001, Merck had data that Vioxx patients in two Alzheimer’s studies had a higher death rate than patients on dummy pills. Merck didn’t publicize that “in a timely fashion” and provided information to the FDA that downplayed the deaths, the report said.

Senator Charles Grassley (R-Iowa), a long-time critic of both the drug industry and the FDA, said in an emailed statement to Bloomberg.com that the revelations about the ghostwritten Vioxx articles reveal the lengths to which a drug maker might to bury information that might hurt sales. ``Revealing this kind of activity is very important in building pressure on the FDA to regulate, not accommodate drug makers,'' Grassley said.

Vioxx Settlement Meets Vital Deadline

Thu, 06 Mar 2008 00:00:00 -0800

The Vioxx settlement passed yet another milestone. Enough people have signed on to Merck & Co.'s pending $4.85 billion Vioxx settlement to keep settlement activities moving forward, the drug maker announced. Vioxx, or refecoxib, is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) and works by reducing substances that cause inflammation, pain, and fever. Vioxx was pulled from the market in 2004 after being linked to cardiovascular problems. After a few years of litigation, a comprehensive settlement was proposed in November. Under the settlement plan, Merck agreed to compensate plaintiffs who can show, under certain conditions, that taking the drug was connected their having suffered a heart attack or stroke.

Over 95 percent registered cases against Merck & Co. by the January 15th deadline, much more than the minimum required to proceed. Also, parties involved in the lawsuit have agreed on some amendments that resolve one outstanding issue and make payouts more attractive to those plaintiffs who have been holding out for a better deal. The company said over 44,000 of the 47,000 claimants who registered injuries eligible for compensation have submitted some or all of the documentation required to seek a share of the settlement. Friday was the deadline for accepting the offer; at least 85% of eligible claimants had to enroll by submitting forms and medical authorizations in order to validate the deal. It isn't yet clear how many of those submitting paperwork meet all the criteria. Those who submitted partially completed enrollment packages have until March 31 to provide the rest of their materials.

Claimants are now required to provide medical records that third-party administrators will use to assess for what payment they might qualify. Under the plan, a claim must be based on an incidence of heart attack, ischemic stroke, or sudden cardiac death. Plaintiffs must provide documentation indicating Vioxx was taken for at least 30 days and the injury occurred within 14 days of using the drug. Payouts will be adjusted according to other cardiovascular risk factors.

Plaintiffs lawyers estimate that, depending on age and risk factors, settlement payments will range from $50,000 to $1.5 million, with an average exceeding $200,000. Merck set aside $1.9 billion for litigation costs—not including payouts—and spent $1.2 billion. Plaintiffs had trouble persuading juries that Vioxx, and not other risk factors, caused injuries. Of the 16 cases that went to trial, Merck won 11; however, at the first Vioxx trial, a jury in August 2005 awarded a Texas widow $253.4 million—later reduced to $27.2 million, including interest.

Lawyers around the country objected to a clause that required them to recommend the settlement to either all or none of their clients and to take steps to drop those who wished to opt out. Lawyers contesting that all or nothing provision filed motions citing ethical obligations to provide clients individual counsel not predicated on potential conflicts of interest. They have either withdrawn the motions or indicated their intention to do so and there are no pending motions related to the settlement plan. Merck agreed to remove the $600,000 cap on supplementary payments to individual claimants able to prove "extraordinary injury.”

Vioxx Lawsuit Settlement Deadline Extended

Fri, 22 Feb 2008 00:00:00 -0800

Vioxx plaintiffs have some more time to apply for a settlement over the defective drug. Lawyers now have an extra month to submit paperwork for their client seeking early payment from a $4.85 billion federal court settlement involving the painkiller Vioxx. The deadline for enrolling plaintiffs to receive the early payments from Merck & Co. is February 29th. Some lawyers are having trouble obtaining and compiling all the necessary medical and other supporting paperwork, so the deadline for that submission has been moved to March 30th, lawyers told U.S. District Judge Eldon Fallon on Thursday. Those whose lawyers submitted their names and Social Security numbers by February 29th and their medical and other supporting paperwork by March 30th could receive partial payments by late summer, Kent Jarrell, a Merck spokesman, said.

Attorneys registered over 58,000 people as interested in the settlement and have formally enrolled over 13,200, Jarrell said. A rush is expected to occur in the final 24 to 48 hours, but numbers are changing by the minute, said Warren Brown of Brown Greer LLC, the company administering the settlement. "There were more than 29,000 yesterday. This morning, it was 30,041," he said. About 26,000 to 27,000 of those suffered heart attacks or strokes, which they blame on Vioxx, adding that lawyers listed more than 20,000 claims in the 48 hours before the January 15th registration deadline. Lawyers have at least until July 10th, and even as late as October 30th of this year, to file claims for those not seeking early partial payments.

Lawyers for Merck and the plaintiffs say the agreement could close most of the 61,100 cases, which includes about 47,000 people whose lawsuits were filed before the settlement was announced on November 9th and another 14,100 with agreements with Merck permitting them to file after the statute of limitations ran out—generally, two or three years following an alleged injury. Merck said at least 85 percent of people in different groups of claimants must sign on for the agreement to pass.

A lawyer for 230 Florida residents asked Fallon to add them to the list of those eligible saying he had agreements with the committee of lawyers set up to represent plaintiffs in the federal litigation before the judge. Suits were not filed for the group because Florida's four-year statute of limitations had not run out; the attorney claims he had no way of knowing the settlement's limits because Fallon ordered secret negotiations.

Rofecoxib is a nonsteroidal anti-inflammatory drug—or NSAID—developed by Merck for the treatment of osteoarthritis, acute pain conditions, and dysmenorrhoea and gained widespread acceptance among physicians. Worldwide, over 80 million people were prescribed rofecoxib—also known as Vioxx—at one time or another. Vioxx was approved as safe and effective by the Food and Drug Administration (FDA) on May 20, 1999 and was subsequently marketed under the brand names Vioxx, Ceoxx, and Ceeoxx. On September 30, 2004, Merck voluntarily withdrew rofecoxib from the market over concerns of increased risk of heart attack and stroke associated with long-term, high-dosage use. Vioxx was one of the most widely used drugs ever to be withdrawn from the market.

Florida Vioxx Plaintiffs Look to Expand Settlement

Wed, 30 Jan 2008 00:00:00 -0800

Vioxx plaintiffs in Florida are petitioning a federal court to expand Merck’s proposed $4.85 billion settlement to include those who did not file suit against the company by Nov. 9, 2007. But many lawyers involved in the Vioxx settlement oppose the petition, fearing that adding more plaintiffs to the Vioxx settlement would lessen the awards each eligible participant would receive. However, if the situation is not resolved, Vioxx patients who did not file suit against Merck by the November 9 deadline could still bring their own lawsuits. But that means Merck’s Vioxx troubles – which the $4.85 billion settlement was supposed to resolve – would be far from over.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

When the Vioxx settlement agreement was announced on Nov. 9, 2007, it only applied to Vioxx patients who had filed suit by that day. Under Florida law, Vioxx plaintiffs had until Sept. 30, 2008 to file suit — four years after Merck pulled Vioxx from the market. So by the November 9 deadline, about 300 Florida Vioxx plaintiffs had still not filed their lawsuits, nor had they reached agreements with Merck for deadline extensions.

According to the Associated Press, the Florida lawyers representing these plaintiffs say they had an agreement to set up an "amicable, working relationship" with the plaintiffs' steering committee "for the mutual benefit of their clients," and had submitted a list of clients who had not yet filed suit. However, they said, they weren't informed that a settlement was close, and therefore could not get their clients' situation considered.

If the motion to expand the Vioxx settlement is granted, it could have ramifications well beyond Florida. Lawyers for the Florida plaintiffs told the Associated Press that states with even longer statutes of limitations could be affected by a decision if their lawyers had similar agreements with the steering committee. North Dakota residents had six years, Missouri residents had five and Wyoming residents four. According to the Associated Press, Maine residents also have six years to file Vioxx lawsuits, and those in Nebraska and Utah have four.

In New Orleans, the federal judge overseeing the Vioxx settlement dismissed the motion filed Monday. But a lawyer for the Florida plaintiffs said a substitute was being filed, and a hearing was tentatively scheduled Feb. 21.

Vioxx Settlement Gaining Ground, with 95 Percent of Plaintiffs Signing On

Tue, 22 Jan 2008 00:00:00 -0800

The pending Merck Vioxx settlement appears to be on track, as more than 95 percent of possible Vioxx claimants have signed on to Merck’s $4.85 million settlement offer. In other developments, lawyers opposed to an “all or nothing” provision in the proposed Vioxx settlement, have apparently agreed to wording that makes the settlement more palpable.

Over 57,100 claimants of an estimated 60,100—or more than 95 percent—registered their cases against Merck & Co. by the January 15th deadline. This amount is much more than the minimum required to proceed against Merck in the Vioxx suit. Vioxx, or refecoxib, is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) and works by reducing substances that cause inflammation, pain, and fever. Vioxx, a widely used painkiller, was pulled from the market in 2004 after being linked to cardiovascular problems. Under the settlement plan announced in November, Merck agreed to compensate plaintiffs who can show, under certain conditions, that taking the drug was connected their having suffered a heart attack or stroke.

Prospects for Merck & Co.'s $4.85 billion Vioxx settlement grew more promising for the plaintiffs with claimant involvement over 95 percent exceeding what was expected. Also, parties involved in the lawsuit have agreed on some amendments that resolve one outstanding issue and make payouts more attractive to those plaintiffs who have been holding out for a better deal. "That's really remarkable in my view," said plaintiffs attorney Andy Birchfield, who was on the settlement-negotiating committee. At a status conference in federal court in New Orleans Friday, lawyers for Merck and the plaintiffs resolved some conflicting issues. Groups of lawyers around the country had objected to a clause that required them to recommend the settlement to either all or none of their clients and to take steps to drop those who wished to opt out. Lawyers contesting that all or nothing provision filed motions citing ethical obligations to provide clients individual counsel not predicated on potential conflicts of interest. They have either withdrawn the motions or indicated their intention to do so, according to Kent Jarrell, Merck's Vioxx legal spokesman. "There are no pending motions anywhere" related to the settlement plan, he confirmed.

The attorneys appear to be satisfied with an addition to the deal that says, "Each Enrolling Counsel is expected to exercise his or her independent judgment in the best interest of each client individually before determining whether to recommend enrollment in the Program." Lawyers for both sides said this is a point of clarification but not a substantive change.

The real test of the deal's viability will come next month, when 85% of the 57,100 claimants must enroll their cases by submitting releases and medical records by the mandated February 29th deadline. Jarrell says Merck, of Whitehouse Station, N.J., expects the threshold will be met, adding that 3,065 claimants already have begun the enrollment process.

There is another amendment to the settlement that might encourage plaintiffs with strong cases to settle and not risk the odds of winning a big verdict in court. Merck agreed to remove the $600,000 cap on supplementary payments to individual claimants able to prove "extraordinary injury.”

Celebrex, other COX-2 Inhibitors May Cause Heart Arrhythmias

Thu, 17 Jan 2008 00:00:00 -0800

Research on fruit flies and rats has found that COX-2 inhibitors, a class of painkillers that includes Celecoxib (brand name Celebrex) and the ill-fated Vioxx, can cause heart arrhythmias. Since Vioxx was pulled from the market several years ago after being linked to heart attacks, research on COX-2 inhbitors has become more vigrourous.

In both fruit fly and rat models, researchers discovered that Celebrex can induce heart arrhythmia. More interestingly, this effect is independent of the COX-2 enzyme. Arrhythmias are disorders of the regular rhythmic beating of the heart and can occur in a healthy heart and be of minimal consequence. They may also indicate a serious problem and lead to heart disease, stroke, or sudden cardiac death. COX-2 inhibitors are newly developed drugs for inflammation that selectively block the COX-2 enzyme. Blocking the COX-2 enzyme stops the production of the chemical messengers—or prostaglandins—that cause the pain and swelling of arthritis inflammation. COX-2 selective inhibitors are a new class of nonsteroidal anti-inflammatory drugs, or NSAIDs that directly targets the COX-2 enzyme. Because they selectively block the COX-2 enzyme—the enzyme responsible for inflammation and pain—and not the COX-1 enzyme, these drugs are uniquely different from traditional NSAIDs.

Satpal Singh and colleagues tested various Celecoxib doses on the heart rate of Drosophila, a genus of small flies often referred to as fruit flies or vinegar flies, because of their tendency to linger around over-ripe or rotting fruit, and a good model for human cardiac pharmacology. To their surprise, administering 3 ƒÝm Celecoxib—which is not much higher than the plasma levels in humans taking the drug—reduced the heart rate and increased beating irregularities, while 30 ƒÝm was enough to stop the heart within one minute. Researchers were surprised at the results because Drosophila do not have COX-2 enzymes. Rather, Celecoxib could directly inhibit the potassium channels that help generate the electric current that drives heartbeat. The researchers were able to achieve similar heart-stopping results in rat cardiac cells, whereas aspirin, another potent COX-2 inhibitor, had no effect, confirming that another mechanism is at work. The drug also inhibited rat and human potassium channels expressed in a human cell line.

Singh and colleagues point out that since these arrhythmia effects bypass COX-2, it is unclear if other COX-2 inhibitors would yield similar results. They also stress it is too early to speculate on human effects, although their results suggest Drosophila—one of the most valuable of organisms in biological research and has been used as a model research organism for almost a century—are a valuable tool to investigate other COX-2 drugs.

Late last summer, authors of an article published in a special cardiology issue of The Lancet wrote that use of celecoxib after stent implantation in patients with coronary artery disease is safe, reducing the need revascularisation of the target lesion; however, an accompanying comment warned that clinical trials indicated that long-term use of celecoxib can expose patients to an additional risk of heart attack.

A 2006 review of 138 randomized trials and almost 150,000 participants revealed selective COX-2 inhibitors were associated with a moderately increased risk of vascular events, mainly due to a twofold-increased risk of myocardial infarction.

Big Vioxx Settlement Deadline Today

Tue, 15 Jan 2008 00:00:00 -0800

Vioxx patients who where injured by the defective drug have until the end of business today to decide whether or not to take part in a proposed $4.85 billion settlement with Merck Inc. According to Bloomberg.com, about half of the 60,800 people who sued have already signed up. Of those, 29,000 claimed heart attacks and 17,000 claimed strokes. For the Merck Vioxx settlement to take effect, 85 percent of heart attack and stroke claimants must sign up by today's deadline.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Merck has already spent $1.2 billion fighting Vioxx lawsuits prior to the announcement of the settlement. Merck said it planned to announce the final registration tally at a court hearing on Jan. 18 in New Orleans federal court.

In order to be eligible for the settlement, Vioxx claimants will have to enter into a resolution process. Merck will set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. The settlements will be awarded on an individual bases, and the amount of money each plaintiff ultimately receives will vary. Under the terms of the Vioxx settlement agreement, Merck has admitted no fault for the defective drug.

But the Vioxx settlement agreement, which was reached by Merck and plaintiffs’ attorneys from several large law firms, is not popular with all Vioxx plaintiff lawyers. Merck has tried to coerce Vioxx plaintiffs to take the offer by including an “all or nothing” provision in the settlement. According to that provision, before they can take part, lawyers must agree to recommend the deal to all their clients — and withdraw from representing those who do not enter into the settlement. Some plaintiffs’ attorneys are saying that while the Vioxx settlement is appropriate for some of their clients, it does not serve the interests of all. .

Already, motions have been filed to strike the “all or nothing” provision from the Vioxx settlement. The Wall Street Journal reported last week that one of these motions, filed by lawyers from Missouri and Illinois, is scheduled for a hearing Jan. 18 before U.S. District Judge Eldon E. Fallon of New Orleans, who is overseeing the settlement. Another motion by lawyers from Kentucky and Indiana hasn’t yet been set for a hearing.

Those Vioxx victims who do not decide to participate in the Merck settlement will still have the option of suing the drug maker on their own, but if the “all or nothing” provision is allowed stand, they might have difficulty finding lawyers to represent them in their fight against Merck.

Deadlines Mean Vioxx Lawsuit Plaintiffs Have Big Decisions to Make

Thu, 10 Jan 2008 00:00:00 -0800

With deadlines looming, many people injured by Vioxx will need to decide if they want to be part of the $4.85 billion settlement that Merck proposed late last year. But while it does appear that most Vioxx plaintiffs will participate in the settlement with Merck, a good number of others are indicating that they will decline.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Since then, tens of thousands of Vioxx victims have sued Merck.

Under the proposed Vioxx settlement, Merck is to set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. According to The Wall Street Journal, plaintiffs who agree to the Merck Vioxx settlement could see payments ranging from $50,000 on the low end to $1.5 million at the top, with an average above $200,000. Those amounts are subject to attorneys' fees, expenses and liens from government entities like Medicaid and Medicare.

According to The Wall Street Journal, Jan. 15 is the deadline when all plaintiffs with a Vioxx-related case must register -- whether or not their injuries would necessarily qualify for the settlement payout. This preliminary step will establish how many cases Merck faces. Those that don't qualify for the settlement could still go to court. The second big deadline comes Feb. 29, when the estimated 45,000 plaintiffs with heart-attack and stroke cases that qualify for the settlement must enroll.

But the settlement will only take effect if 85 percent of those suing Merck over Vioxx injuries agree to accept it by the last deadline. Merck has tried to coerce Vioxx plaintiffs to take the offer by including an “all or nothing” provision in the settlement. According to that provision, before they can take part, lawyers must agree to recommend the deal to all their clients — and withdraw from representing those who do not enter into the settlement.

Some lawyers say this provision of the Vioxx settlement puts them in a difficult position. They argue that t while the Vioxx settlement is appropriate for some of their clients, it does not serve the interests of all. They also feel that the stipulation prevents them from offering the best independent judgment for each client, and opens them up to future lawsuits from disgruntled clients.

Already, motions have been filed to strike the “all or nothing” provision from the Vioxx settlement. The Wall Street Journal is reporting that one of these motions, filed by lawyers from Missouri and Illinois, is scheduled for a hearing Jan. 18 before U.S. District Judge Eldon E. Fallon of New Orleans, who is overseeing the settlement. Another motion by lawyers from Kentucky and Indiana hasn't yet been set for a hearing.

Mercks Vioxx Payouts to Begin in August

Tue, 01 Jan 2008 00:00:00 -0800

A consent judgment against Merck, filed in Suffolk Superior Court, prevents the New Jersey-based drug maker from misleading consumers in future advertising and mandates full disclosure of all known risks of Merck drugs. The judgment bans the deceptive use of scientific data when marketing doctors and "ghost writing" articles and studies and addresses conflict of interest issues. Also, Merck must obtain Food & Drug Administration (FDA) approval for direct to consumer television drug advertisements and must comply with regulatory recommendations if the FDA calls for a delay in such advertising. In 2000, Merck spent $160.8 million on direct to consumer Vioxx marketing.

Vioxx Settlement All-or-Nothing Provision Prompts Some Lawyers to Seek Changes

Fri, 21 Dec 2007 00:00:00 -0800

The Vioxx settlement announced with great fanfare last month has not satisfied all Vioxx victims, and now their lawyers are asking a judge to change the terms of the proposed settlement so that they may be excluded from it. As it stands now, the Vioxx settlement has a big string attached to it. To take part, lawyers must agree to recommend the deal to all their clients — and withdraw from representing those who do not agree. Understandably, this all-or-nothing provision is not sitting well with many Vioxx plaintiffs’ attorneys, who say such a stipulation makes it impossible to adequately represent all of their clients.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Since then, tens of thousands of Vioxx victims have sued Merck.

Under the proposed Vioxx settlement, Merck is to set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. The settlements will be awarded on an individual bases, and the amount of money each plaintiff ultimately receives will vary. In order for the Merck Vioxx lawsuit settlement to take effect, at least 85% of those who have filed Vioxx lawsuits and fit the proposal’s criteria must agree to accept it by March 1, 2008.

The Vioxx settlement agreement was reached by Merck and plaintiffs’ attorneys from several large law firms. But other lawyers are saying that while the Vioxx settlement is appropriate for some of their clients, it does not serve the interests of all.   In a motion filed in the Federal District Court in New Orleans asking that the all-or-nothing provision be struck down, some lawyers are contending that the stipulation would prevent them from offering the best independent judgment for each client. They also assert that agreeing to the provision might open them to future lawsuits from disgruntled clients.

One legal expert told the New York Times that the provision in question poses an ethical dilemma.   A lawyer is duty bound to represent the best interests of a client, but the Vioxx settlement might not allow for this, Benjamin Zipursky, a professor at Fordham Law School said. “The question is, is this really independent advice given to each client if the lawyer obligates himself or herself to say this to all the clients?” Mr. Zipursky said.

For its part, Merck has very good reasons for wanting to keep the all-or-nothing provision a part of the Vioxx settlement.    According to the New York Times, Merck wants lawyers to put all their clients into it so that it will not face the prospect that they will settle their weaker claims while withholding their stronger cases for trial. Merck also wants to be sure that plaintiffs who do choose to go ahead will have to find new lawyers, a process that will probably be difficult because the firms with the most experience in the case are all part of the agreement. Merck has not said what it will do if the all-or-nothing provision is removed from the Vioxx settlement.

Vioxx Lawsuit Settlement Could Rank Among the Largest Defective Drug Settlements

Mon, 12 Nov 2007 00:00:00 -0800

Merck’s proposed Vioxx settlement could become on of the largest defective drug lawsuit settlements in history if it is accepted by a majority of Vioxx victims who have filed lawsuits against the company for strokes and heart attacks they say where caused by the painkiller. Late last week, Merck proposed settling the majority of pending Vioxx lawsuits for $4.85 billion -- just one month after the pharmaceutical giant had vowed to fight each suit individually.

In order for the Merck Vioxx lawsuit settlement to take effect, at least 85% of those who have filed Vioxx lawsuits and fit the proposal’s criteria must agree to accept it by March 1, 2008. To be eligible for the settlement, plaintiffs must have filed Vioxx claims by last Thursday, November 8, 2007.   They must also be able to provide medical proof that they suffered from a stroke or heart attack, that they received at least 30 Vioxx pills, and that they where taking the medication within two weeks of having a heart attack or stroke. For its part, the Vioxx settlement does not require Merck to admit any fault.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

Last Friday’s Vioxx settlement announcement came as a big surprise to many Merck watchers.   Merck, which is being sued by as many as 50,000 Vioxx victims in the US, had vowed to fight every lawsuit on an individual basis. But that would have been an expensive proposition, and most legal analysts agree that Merck’s offer of $4.85 billion to settle Vioxx cases was a good move. Of the 11 Vioxx lawsuits that went to trial thus far, Merck had lost five.

Merck will set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes.   The settlements will be awarded on an individual bases, and the amount of money each plaintiff ultimately receives will vary.   Merck said that at this time, it has not determined how many former Vioxx users might be covered by the agreement. Exactly how much each individual settlement award might be is also not known. The amounts will vary depending on the severity of injuries, the length of time that a plaintiff used Vioxx, and each patient’s risk factors for cardiovascular disease. If the Merck Vioxx settlement is accepted, payments could start as early as August 2008.

Vioxx Victims to Share $4.85 Billion under Settlement Agreement with Merck

Fri, 09 Nov 2007 00:00:00 -0800

Vioxx maker Merck will spend $4.85 billion to settle a significant number of lawsuits filed against it for injuries caused by the painkiller. Under the agreement, which was announced late yesterday, Merck will set up two separate settlement funds to cover heart attack and stroke claims filed over Vioxx. The development is a surprising one, considering that until very recently Merck had vowed to fight every one of the 27,000 cases filed against Vioxx individually.

In order to be eligible for the settlement, Vioxx claimants will have to enter into a resolution process. Merck will set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. The settlements will be awarded on an individual bases, and the amount of money each plaintiff ultimately receives will vary. Merck said that at this time, it has not determined how many former Vioxx users might be covered by the agreement.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered Vioxx off the market in 2004 after studies showed that people who took the drug had a higher risk for heart attack. The recall came after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Since then, Vioxx the subject of 27,000 law suits filed by 47,000 plaintiffs as the result of Vioxx side effects. In addition, the company also faced 265 potential Vioxx class action lawsuits, and it has also been sued by several states in an effort to recoup the money state health programs spent on Vioxx prescriptions.

Merck had vowed to fight every Vioxx lawsuit individually, and it was having some mixed success. Of 11 Vioxx cases that have gone to trial so far, Merck had lost five. But the legal costs of defending so many Vioxx lawsuits have been substantial. Merck spent $160 million just in the third quarter to fight Vioxx lawsuits. The company also took several charges against its earnings to cover current and future Vioxx litigations costs, and it has set aside $720 million to cover the legal costs associated with these lawsuits. However, that amount did not cover any potential damage payments to Vioxx victims.

Under the new Vioxx agreement, Merck will make no admission of fault. The company has also said that it will continue to vigorously defend against individual Vioxx lawsuits that are not included in the new Vioxx settlement agreement.

Vioxx Lawsuit Asks that Merck Pay for Medical Monitoring

Fri, 26 Oct 2007 00:00:00 -0700

Vioxx users, anxious that they could have unknowingly suffered health consequences from using the defective drug, have taken Vioxx maker Merck to court in New Jersey.   The former Vioxx users want Merck to pay for medical monitoring in order to insure that they have not suffered from a “silent heart attack” as a result of their Vioxx use.

Vioxx was pulled from the market by Merck three years ago after research indicated that it could double a patient’s risk of heart attacks and strokes. Before the Vioxx recall, the arthritis drug had been one of Merck’s biggest selling drugs. The recall came after a Food & Drug Administration analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

Now, New Jersey residents Robbie Traylor and Joseph Murray have asked the New Jersey Supreme Court to certify a class action for their Vioxx lawsuit, which seeks to have Merck pay for their medical monitoring. Both took Vioxx for years, but are not exhibiting heart symptoms right now. If certified a class action, the lawsuit would cover about 233,000 New Jersey Vioxx users; and if it is successful, Merck would have to pay out about $35 million for the medical testing. Each plaintiff covered by the class action would then be entitled to an EKG exam to see if they had an undetected heart attack.   According to the plaintiff’s attorneys, it is likely that about 1,800 of the 233,000 Vioxx users would discover that they suffered heart damage as the result of Vioxx.

For its part, Merck is claiming that such a lawsuit is not allowed under New Jersey’s product liability law. Rather, the company’s attorneys argue that the state law only allows medical monitoring when there is evidence of a specific injury.   But the Vioxx users’ lawyers argued that without medical monitoring, many of the plaintiffs will never know if they suffered injuries from Vioxx side effects.

Merck is facing more than 26,000 law suits filed by 47,000 plaintiffs as the result of Vioxx side effects. In addition, the company might also have to defend 265 potential class action lawsuits.   Merck has also been sued by several states in an effort to recoup the money state health programs spent on Vioxx prescriptions.

Merck has said that it plans to fight each Vioxx lawsuit individually, and will appeal any case it looses.   Merck says that it had reserved $1.92 billion to fight Vioxx lawsuits, and has already spent around $1.2 billion.

FDA Must Produce Vioxx Documents

Wed, 17 Oct 2007 00:00:00 -0700

Vioxx documents requested by an attorney must be turned over by the Food & Drug Administration (FDA), a US District Court Judge has ruled. The decision came after the attorney had taken the FDA to court claiming that the agency had ignored repeated Freedom of Information Act (FOIA) requests for the documents.

Merck, the maker of Vioxx, removed the medication from the market in 2004 after an FDA study estimated that Vioxx could have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. Shortly after it was revealed that the FDA had tried to silence the drug expert who headed that study. Dr. David Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.

According to the complaint filed in US District Court for the District of New Jersey, the attorney made 10 separate FOIA requests to the FDA for various documents regarding Vioxx. The documents included clinical trail data, adverse event reports, Vioxx advertisements and correspondence between the FDA and Merck regarding the drug. Agencies have 20 days to respond to such requests. The complaint alleges that the FDA did not produce all of the requested documents in a timely manner, did not produce documents in two requests and did not even respond to five of the FOIA requests. Furthermore, the complaint says that many of the documents the FDA did produce were incomplete.

The FDA claimed that the delays were due to a backlog of similar Vioxx FOIA requests as a result of the large amount of ongoing litigation surrounding the drug. However, the federal judge ruled that the number of requests was insufficient to warrant the delay. The judge ruled against the FDA’s request that the agency be allowed to delay turning over the documents. The judge also said that a mediator would be appointed to create a process for determining what Vioxx documents the FDA must produce.

Merck now faces more than 27,000 lawsuits over the defective drug. The company has already spent $1.04 billion on its defense against Vioxx lawsuits. Merck is named in 266 potential class-action lawsuits, one class-action certified in Canada and lawsuits from seven states to recoup what they paid for Vioxx through Medicaid. Starting next year, Merck will face the first Vioxx trials that involve patients who had strokes.

Vioxx Maker Merck Sued by New York For Medicaid Fraud

Wed, 19 Sep 2007 00:00:00 -0700

Vioxx, a defective drug pulled off the market in 2004, is the target of yet another lawsuit. Earlier this week, the state of New York joined with New York City in a Medicaid fraud lawsuit against Merck, the maker of Vioxx, in an effort to recoup the money state health programs spent on Vioxx prescriptions.

The Food & Drug Administration (FDA) ordered Vioxx off the market in 2004 after studies showed that people who took the drug had a higher risk for heart attack.   The recall came after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

In a statement released on Monday, New York State Attorney General Andrew Cuomo said that “Merck’s duplicitous and irresponsible conduct endangered New Yorkers and wasted our tax dollars.” Between 1999 and 2004, New York State spent more than $100 million on Vioxx prescriptions through Medicaid and the Elderly Insurance Coverage program.   Most of the Vioxx prescriptions would never have been written had Merck been forthcoming about the drug’s potential risks, the statement said.

This is the first time the state of New York and New York City have joined together in a Medicaid fraud lawsuit.   The complaint was filed under a new state false claims law that allows for triple damages and civil penalties.   The statement said that New York City had paid a “substantial share” of the costs for people on Medicaid.   “This is another step in the city’s continuing litigation effort to recoup the millions of dollars in overcharges by pharmaceutical companies to Medicaid Program for prescription drugs,” said New York Mayor Michael Bloomberg in the same statement.

This lawsuit is only the latest filed by states seeking to be reimbursed for money spent on Vioxx and treating people injured by its side effects. Alaska, Louisiana, Mississippi, Montana, Texas and Utah have filed similar actions. The suits have involved both consumer and Medicaid fraud, and focus on pricing and safety.

For its part, Merck denies the allegations, and says that it acted responsibly.      The company issued a statement yesterday claiming that it had monitored Vioxx while on the market, appropriately labeled it and voluntarily removed it when problems became evident. Merck said that it would continue to “vigorously defend” Medicaid fraud lawsuits.

Merck is facing 27,000 suits over Vioxx. Earlier this summer, a New Jersey judge upheld a $13.5 million verdict against Merck, won by a couple who sued over injuries the man sustained after he took Vioxx.

Possible Cause of Vioxx Heart Attack Risk Discovered

Mon, 27 Aug 2007 00:00:00 -0700

Vioxx and other cox-2 inhibitors increase the production of a protein that encourages blood clotting, concludes a study published in The Journal of Experimental Medicine.   The over-production of the protein, known as tissue factor (TF), could account for the increased risk of heart attacks associated with cox-2 inhibitors like Vioxx.

The Food & Drug Administration (FDA) ordered Vioxx off the market in 2004 after studies showed that people who took the drug had a higher risk for heart attack.   The recall came after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. After Vioxx was pulled from the market, it was revealed that the FDA had tried to silence the drug expert who headed that study. Dr. David Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings

The Vioxx debacle has spawned hundreds of lawsuits against its maker, Merck. Earlier this month, a New Jersey judge upheld a $13.5 million verdict against Merck, won by a couple who sued over injuries the man sustained after he took Vioxx.

The study published in The Journal of Experimental Medicine was conducted by researchers at the University of Connecticut Health Center. In experiments using lab mice, the researchers discovered that use of cox-2 inhibitors increased the production of TF in the heart, lungs and blood of the animals. Heart attacks and strokes are triggered by blood clots, so increase production of TF could account for the heart attack risk associated with Vioxx.

Other research has shown a link between cox-2 inhibitors and lower prostacyclin levels as a possible reason for higher cardiac risks.   Prostacyclin is another protein that prevents blood clots, and it is known that Vioxx and other drugs in its class lower prostacyclin levels.

The researchers believe that other cox-2 inhibitors in addition to Vioxx also increase TF levels. One cox-2 inhibitor, Celebrex, is still on the market.   It is also possible that the risk extends to non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and Aleve. Patients should use caution when taking any of these medications.

The University of Connecticut researchers also found that TF-blocking agents could reduce high levels of the protein in mice.   The researchers speculated that giving patients TF-reducing agents could mitigate the cardiac risks posed by Vioxx and other cox-2 inhibitors.   However, no TF-blockers have been approved for use. And despite the findings in mice, research must still prove that cox-2 inhibitors promote the production of TF in humans.

FDA Approving Fewer New Drugs in Wake of Vioxx, Avandia, Other Scandals

Thu, 23 Aug 2007 00:00:00 -0700

The Food & Drug Administration (FDA) is still struggling to regain credibility after its approval process came under fire as a result of scandals surrounding drugs like Vioxx, Avandia and Ketek. That could be one reason why the FDA is approving new medications at a much slower rate than in the past. Since January, the FDA has approved only 38 new drugs. During the same period in 2006, the FDA had already approved 55 new medications.

In the past several years, the FDA’s drug approval process has been criticized for allowing defective drugs to go on the market even when serious questions were raised about their safety. Ketek is a prime example of the FDA’s lax approval process. Ketek, an antibiotic used to treat sinus infections, was granted FDA approval in 2004, even though the FDA had found serious irregularities in clinical trials conducted by its manufacturer, Sanofi-Aventis. At least one doctor involved in the trial falsified data and was sent to prison for fraud. Still, Ketek was approved by the FDA in 2004. Shortly after it approved Ketek, the FDA began receiving reports that linked it to liver problems. The FDA eventually confirmed 53 cases of liver failure in patients using the antibiotic, including five deaths. This past February, the FDA finally added black box warnings to the Ketek label and severely restricted its use.

Vioxx, another FDA approved drug, has been linked to severe heart problems. In 2004, an FDA study estimated that this defective drug could have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. After Vioxx was pulled from the market in 2004, it was revealed that the FDA had tried to silence the drug expert who headed that study. Dr. David Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.

Avandia is another drug that has caused the FDA a great deal of embarrassment. In May, a study by the Cleveland Clinic found that the diabetes drug increased a patient’s risk of heart attack by 43-percent. In June, a congressional committee convened hearings to investigate problems with the drug. The committee heard testimony from Dr. John Buse, a diabetes expert who raised questions about Avandia’s cardiac risks in 1999. Dr. Buse told the committee that he felt pressured by the drug’s maker, SmithKlineBeecham (now part of GlaxoSmithKline) to sign a clarifying statement drafted by the company that downplayed his concerns. Testimony at that hearing also revealed that the manufacturer and the FDA had known about Avandia’s heart attack risk as far back as September 2005. However, the agency felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues.

All of these scandals have damaged the public’s confidence in the FDA’s ability to insure drug safety. The fact that the FDA has approved fewer new medications this year could be a sign that the agency is finally starting to take that seriously.

Eli Lilly Settles Zyprexa Lawsuits; Attempts to Shift Blame to Legal Advertising

Tue, 19 Jun 2007 00:00:00 -0700

Eli Lilly, the makers of Zyprexa announced it had settled another 900 lawsuits against its anti-psychotic medication Zyprexa, on that very same day Eli Lilly was claiming that legal advertisements where hurting patients. The company asserts that a recent study showed that patients using Zyprexa were more likely to abruptly stop taking it once they were exposed to legal advertising highlighting its harmful side effects. The study, which Eli Lilly paid for, surveyed only 402 patients – a small number considering that an estimated 2 million people may be using Zyprexa.

While they agree that patients should never stop a medication without first consulting their physician, many plaintiff attorneys were incredulous at Eli Lilly’s claims. They point out that the company itself was slow to warn patients that Zyprexa could cause diabetes and high blood sugar. Even the FDA, the federal agency that is supposed to insure drug safety, often takes too long to inform the public of drug dangers.

Consumer advocacy groups like Public Citizen site instance after instance where the FDA allowed drugs to remain on the market without warnings of side effects. For example, the arthritis drug Vioxx managed to get FDA approval even after it was linked to serious cardiac complications. Public Citizen and others claim that the FDA has become too close to the pharmaceutical industry, thus allowing for the lack of oversight. In fact, 10 of the 32 members on the FDA panel that initially investigated Vioxx had received consulting fees or research funds from drug companies. That panel voted to keep the dangerous drug on the market even as evidence of its side effects continued to mount.

The situation surrounding Eli Lilly’s Zyprexa is another example of how pharmaceutical firms and the FDA often fail to adequately warn patients of drug dangers. Zyprexa, which is used to treat schizophrenia and bipolar disorder, has the potential to cause blood sugar levels to rise. This can lead to diabetes and even death. In 2006, the New York Times reported that Eli Lilly knew this as early as 2000, but did not make that information public until 2001. So far, Eli Lilly has paid out over $700 billion dollars in liability claims over Zyprexa.

Despite the controversy surrounding Zyprexa, the FDA still has not required Eli Lilly to publish Medication Guidelines for the drug. The FDA is supposed to require the Medication Guidelines if a drug meets one of three criteria: (1) if doing so could prevent serious side effects; (2) if a drug has serious risks relative to benefits that a patient needs to be aware of; or (3) if adherence to directions for use is crucial to the drug’s effectiveness. Zyprexa meets the first two standards, but as of today, the FDA has not required Eli Lilly to write Medication Guidelines.

It is clear the legal advertising decried by Eli Lilly has become a new warning system for dangerous drugs. At times it’s the legal advertisement itself that first brings to light any indication to a patient that the drug they are taking may actually be doing more harm than good. If the drug companies and the FDA would put patient well-being ahead of profit, there would be no need for law firms to disseminate this information.

Vioxx Heart Attack Lawsuit

Tue, 19 Jun 2007 00:00:00 -0700

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Injured by Vioxx?

Parker Waichman Alonso LLP Has Been Representing Vioxx Heart Attack & Stroke Victims Nationwide Since 2001. Merck & Co. removed its blockbuster arthritis drug Vioxx (Generic: Rofecoxib) from the market worldwide because new data from a clinical trial found an increased risk of heart attack and stroke. Merck decided to remove the drug from the market on September 30, 2004, after data from the trial showed an increased risk of heart attack, stroke, blood clots and other cardiovascular complications. Parker & Waichman has been the choice for Vioxx victims in need of a pharmaceutical liability lawyer since 2001.

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The data comes from a three-year study aimed at showing that Vioxx at a 25 milligram dose prevents recurrence of polyps in the colon and rectum. The trial was stopped after Merck discovered the higher heart risk compared to patients taking dummy pills.

Before the withdrawal of Vioxx, the FDA announced that patients taking Vioxx have a 50 percent greater chance of heart attacks and sudden cardiac death. he study, presented at an epidemiologists conference, also found patients taking the highest recommended daily dosage of Vioxx had three times the risk of heart attack and sudden cardiac death as those not taking standard painkillers.

The popular and heavily advertised arthritis drugs Vioxx and Celebrex have been linked by researchers to an increase in the risk of blood clots, heart attacks and strokes.The study from the Cleveland Clinic appeared in the Journal of the American Medical Association and was based on an analysis of previous clinical trials. Celebrex and Vioxx are projected to produce U.S. sales greater than $6 billion this year.

In a study of more than 8,000 patients that compared the COX-2 inhibitor rofecoxib Vioxx) with the traditional NSAID naproxen, the risk of cardiovascular problems, including heart attack,chest pain related to heart disease, stroke, sudden death and blood clots, was more than two times higher in the rofecoxib group than in the naproxen group.

Vioxx, like Celebrex, is classified as a COX-2 inhibitor, or coxib. COX-2 inhibitors, like older drugs such as ibuprofen and naproxen, are nonsteroidal anti-inflammatory drugs, or NSAIDs. Older NSAIDs reduce inflammation by blocking an enzyme called COX-2, but they also block another enzyme called COX-1. This enzyme helps protect the lining of the stomach, so blocking COX-2 can cause stomach irritation. COX-2 inhibitors only block COX-2, leaving the stomach-protecting COX-1 alone.

In 2000, Merck spent $160.8 million on direct to consumer Vioxx marketing. Many people are familiar with Vioxx television advertisements featuring the famous figure skater Dorothy Hamill. Sid Wolfe, a physician and director of the Health Research Group of the advocacy group Public Citizen in Washington, D.C. said "Dorothy Hamill doesn't tell people they have a four times higher risk of a heart attack on Vioxx."

If you or a loved one took Vioxx and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.