Documents to show that Merck hid Vioxx risks
While Carol Ernst was expected to have a tough time arguing that her husband lost his life to Vioxx, help is on the way for her from unexpected quarters. To completely debunk Merck’s argument that Vioxx killed no one, Physicians Committee for Responsible Medicine (PCRM), a nonprofit health organization that promotes preventive medicine, plans to announce this week that Merck wrongfully relied on animal tests that showed Vioxx to be safe while setting aside mounting evidence that Vioxx increases risk of cardiac events in human patients. PCRM has obtained previously undisclosed Merck data that form one of the cornerstones of the legal challenge. (Related article: Merck hid Vioxx risks prior to recall)
PCRM is scheduled to release these highly incriminating documents on July 14 and also announce a lawsuit against Merck. The company is expected to face over 100,000 lawsuits resulting from the recall of Vioxx. (Related article: Merck knew of Vioxx risks despite its denials)
Neal D. Barnard, M. D., president and founder of Physicians Committee for Responsible Medicine, will be joined by their attorney Dan Kinburn, Esq. Dr. Muhammad Mamdani, the lead author of a recent study in The Lancet that links Vioxx to congestive heart failure, will also be on the panel. Nancy Tufford of Minneapolis will also be the press conference. She was a healthy woman prior to taking Vioxx and is now suing Merck after she developed congestive heart failure. (Related article: Merck intimidated Vioxx critics)
PCRM is a highly respected organization and recently sued several food companies for falsely claiming that eating more dairy products can reduce weight.
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Important questions unanswered as Vioxx trial starts
As the lawsuit by Carol Ernst goes to trial this morning in Texas despite Merck’s desperate attempts to delay it, several key questions still intrigue Vioxx victims. While the trial will definitely shed more light on on many of these issues, and thus, help other plaintiffs whose attorneys will know better what to do and not to do, some of the fundamental issues remain unresolved.
How many people have died after taking Vioxx? In one estimate by the FDA, 140,000 personal injuries are attributed to Vioxx in the United States alone. No estimates are available for other countries. However, no one really knows how many have actually died. While 50,000 deaths were initially estimated, now the world-renowned scientist at the FDA, Dr. David Graham, says that the number is even higher. “By my estimates, FDA’s allegiance to the pharmaceutical industry and its blindness to safety caused the deaths of up to 60,000 Americans from heart attacks with Vioxx,” said Graham last week. It is important to understand that Merck does not think that even one person has died due to Vioxx, and therefore, has vowed to fight each lawsuit individually to show that Vioxx victims died from something else.
What is Merck’s Vioxx liability? This question is of interest both to plaintiffs and Merck shareholders. While Merck’s stock price has taken a big hit since the recall of Vioxx, the bottom has not fallen out yet. That means that many Merck shareholders actually believe Merck’s story and are hoping that not only will the company survive, but may also not have to pay much in Vioxx liabilities. Some of the initial estimates put the liability as high as $51 billion and then there was a consensus on $38 billion. Merrill Lynch analyst David Risinger estimated last year that Vioxx liability may be as low as $4 to 18 billions. According to a news report by CNN, J.P. Morgan analyst Chris Shibutani is estimating that the liability is going to be approximately $25 billion.
Is Vioxx a dangerous drug? If you believe top scientists like Eric Topol and David Graham, then Vioxx is such a dangerous drug that it should have never been approved. Merck disagrees, and so do many other scientists. Canadian doctors recently recommended that Vioxx is safe enough to be allowed back on the market. American doctors (their recommendations were later ignored due to conflicts of interest) had also made a similar recommendation to the FDA. The question that intrigues most people is that if Vioxx led to so many deaths and injuries, why are doctors so enchanted by Vioxx. A theory that is emerging points to the alignment of the interests of doctors and drug firms. Almost all doctors owe something to drug firms and doctors also benefit when more prescription drugs are on the market. When an arthritis patient can get pain relief from Mobic, Aleve, or acupuncture, then how are doctors going to make money by prescribing Vioxx, Celebrex, Bextra, and Arcoxia?
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Ibuprofen has as serious side effects as Vioxx, according to Canadian experts
Vioxx may be sold in Canada again
In a bizarre development, a panel of Canadian expert is recommending that Vioxx, the drug that is estimated to have killed as many as 50,000 Americans and caused 140,000 injuries in the US, be allowed back on the market. Merck voluntarily recalled the drug in September last year after a study showed that it increased the risk of heart attacks and strokes. Since then, Merck is being sued by tens of thousands of Vioxx victims and States of Texas and New York have filed lawsuits for fraud.
A panel constituted by the FDA in February this year made similar recommendations but its recommendations were widely criticized and completely ignored after it was pointed out that several panel members were essentially agents of drug firms like Pfizer and Merck. While Merck announced that it will try to bring Vioxx back on the market, it is highly unlikely that it will happen any time soon as Merck gets bogged down in courts. The first of the Vioxx lawsuits is scheduled to go on trial next week.
Health Canada, the FDA counterpart in Canada, acknowledged the panel’s view that, as a group, selective COX-2 inhibitors are associated with an increased risk of cardiovascular events, a risk that is similar to those associated with most NSAIDs. The panel noted that this risk is present for all patients taking anti-inflammatory agents and that it increases with longer-term use and when other risk factors, such as cardiovascular disease, are present.
Health Canada also acknowledged the panel’s findings that certain drugs in this class are effective anti-inflammatory agents and that the use of these drugs should be left to informed patients, advised by their well-informed health care providers.
In the case of Vioxx, which is not currently authorized for sale in Canada, the panel reported that available data justifies the marketing of Vioxx in Canada because the risk of cardiovascular incidents from Vioxx appears to be similar to that of most NSAIDs. In order for VIOXX to be marketed in Canada, the manufacturer is required to submit a new drug submission to Health Canada. The submission would be carefully reviewed to ensure it meets safety data requirements, with particular attention to the safe labelling issues raised by the panel. Merck has vowed to do the same in the United States.
Immediate actions Health Canada will take include:
- Manufacturers of all NSAIDs currently on the market in Canada will be requested to provide updated patient safety information for these products. This would include Celebrex, which is currently available in Canada by prescription, and ibuprofen products (Advil, Motrin, etc.) currently available over-the-counter.
- Health Canada will continue its assessment of whether Bextra should be returned to the Canadian market after sales were voluntarily suspended in April 2005. The recommendations from the panel will be a key factor in the Department’s final decision, which is expected in the coming weeks. While the FDA forced a recall of Bextra, Pfizer has promised that Bextra will be back on the market in the US and worldwide.
- Health Canada will be conducting further analysis and communicating to provincial health regulators the panel’s recommendations on current over-the-counter availability of some ibuprofen products, in particular to address the possibility of inappropriate, long-term use of these products. FDA has already issued a similar warning about the risks of all NSAIDs. In another study, it was shown that diclofenac also may be as dangerous as other OTC paikillers like Aleve and Mobic.
- Such a recommendation by the expert panel in Canada is bound to hurt the FDA expert Dr. David Graham, who has continued to fight against Vioxx. He even proved that Vioxx was so dangerous a drug that it should have never been approved by the FDA. The Association of Certified Fraud Examiners (ACFE), the world’s leading provider of anti-fraud training and education, today announced that Dr. David Graham will receive its 2005 Cliff Robertson Sentinel Award. Graham’s ongoing crusade for drug safety, despite intense pressure from supervisors and drug manufacturers, earned him this prestigious award.
- Since last August, Graham says that the FDA has not involved him in any new drug safety issues, even though he is its most senior and experienced drug safety researcher. He believes that he has not been fired only because of the personal intervention of Senate Finance Committee Chair Chuck Grassley (R-Iowa). “Because of inherent structural and economic conflicts of interest it is my opinion that the FDA’s Center for Drug Evaluation and Research (CDER) views the pharmaceutical industry as its client and ally. As a result, I believe the public and the nation are virtually defenseless against new drug safety disasters. Unless Congress acts to reform FDA, history teaches us that there will be many more disasters in the future,” says Graham. It is not clear if Health Canada is also as closely aligned with the drug industry as the FDA but it would be no surprise since it caved in under pressure from the drug industry to stop import of prescription drugs from Canada by poor Americans.
Merck Frosst, the Canadian affiliate of Merck & Co. did not release a statement on the developments.
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