Welcome to the Podiatry Arena forums, for communication between foot health professionals about podiatry and related topics.
You are currently viewing our podiatry forum as a guest which gives you limited access to view all podiatry discussions and access our other features. By joining our free global community of Podiatrists and other interested foot health care professionals you will have access to post podiatry topics (answer and ask questions), communicate privately with other members (PM), upload content, view attachments, receive a weekly email update of new discussions, earn CPD points and access many other special features. Registered users do not get displayed the advertisments in posted messages. Registration is fast, simple and absolutely free so please, join our global Podiatry community today!
If you have any problems with the registration process or your account login, please contact contact us.
The Canadian Medical Journal are arguing: Vioxx should be allowed back on the market advises expert panel
Quote:
Rofecoxib (Vioxx) ought to be allowed back on the market, concludes Health Canada's Expert Advisory Panel on the Safety of COX-2 Selective Non-steroidal Anti-Inflammatory Drugs (NSAIDs).
After Merck & Co. withdrew rofecoxib from the world marketplace on Sept. 30, 2004 (CMAJ 2004;171[9]:1027-8), Health Canada launched a review of the cardiovascular (CV) risks associated with COX-2-selective NSAIDs, including rofecoxib, valdecoxib (Bextra), celecoxib (Celebrex) and meloxicam (Mobicox and other generics). The 400-page review includes pre-clinical and clinical trials, adverse drug reaction reports and other data.
In its comments on that review, released in June 2006, Health Canada decided that both rofecoxib and valdecoxib (which was withdrawn in December 2005 following evidence of increase CV events and severe cutaneous adverse reactions) will remain off the market unless a new drug submission is received and approved by Health Canada.
"At this time, we have not made a decision about whether to resubmit," says Merck Frosst spokesperson Marlene Gauthier.
The 13 members of the Expert Advisory Panel, who met for 2 days in Ottawa in June 2005, included people with backgrounds in rheumatology, cardiology, gastroenterology, internal medicine, family medicine, clinical trial methodology and epidemiology, plus 2 patients with rheumatoid arthritis. The report was released in July 2005.
The panel voted 12 to 1 in favour of potential future sales for rofecoxib, noting that most NSAIDs carry cardiovascular risk and that rofecoxib has a decreased frequency of both gastrointestinal intolerance and peptic ulcer diseases compared with traditional non-selective NSAIDs, and that "patients benefit from having a variety of drugs to choose from." The panel did not recommend that valdeocoxib go back on the market due to the rare but severe skin reactions.
"There's no question [rofecoxib] increases cardiovascular risk compared to placebo," says Dr. Andreas Laupacis, who headed Health Canada's Expert Advisory Panel. "But the absolute increase is very small."
Given that the risk is comparable to that of traditional NSAIDs, such as ibuprofen (see article on page 233), but that it has a lower incidence of gastrointestinal problems, "What's the rationale for not making it available?" asked Laupacis the president and CEO of the Institute for Clinical Evaluative Sciences.
Health Canada's comments on that review and own scientific review of certain COX-2s, recommend shorter and lower doses of all COX-2s and traditional NSAIDs.
"That's clear in the report," says Dr. Marc Berthiaume, director of Marketing Pharmaceuticals and Medical Devices Bureau.
During public consultations, Berthiaume says people indicated they wanted to know the risk, but they also wanted to be able to "make that choice."
Health Canada's review concludes that the "benefit–risk balance favours" the continued sale of celecoxib and meloxicam. In accordance with the panel's recommendations, the labels were revised in September 2005 to warn of the increased risk of CV adverse events and to suggest using these drugs at the "lowest effective dose for the shortest possible duration of treatment."
Since the COX-2 withdrawals in 2003, the estimated number of filled prescriptions in Canada has plummeted from 7.3 million (worth about $476 million) to 3.5 million (valued at about $199 million) in 2005.
Merck was hit today with a one-two punch in two separate court decisions relating to its withdrawn pain pill Vioxx.
For the first time, Merck (nyse: MRK - news - people ) lost a Vioxx case in federal court. The plaintiff, 62-year-old Gerald Barnett, was awarded $51 million in compensatory and punitive damages. In the only previous federal case, Merck had emerged victorious.
And Merck's first Vioxx win, from last November, was tossed out because of concerns related to the published scientific data on Vioxx. In that decision, a New Jersey jury ruled that Merck was not liable for the heart attack of Frederick Humeston, an Idaho postal worker. The case will be retried early next year.
Merck shares fell more than 5%, to $39. The company reiterated its plan to fight every Vioxx lawsuit and not give in to pressure to settle. The company will appeal the case.
"Our commitment to defending these cases one at a time remains the same," said Merck chief counsel Kenneth Frazier in a prepared statement. Merck will ask the judge to reconsider the size of the verdict in the federal case, which was tried in New Orleans, and then will appeal it. Phil Beck, who is leading Merck's legal defense, emphasized that there will be some losses.
The double-barreled defeat casts more doubt on Merck's future, just as many industry-watchers were starting to think that its legal strategy might defend the company from the thousands of Vioxx-related suits it is facing. The drug was pulled from the market two years ago after a study found that it increased the risk of heart attack and stroke.
By battling every case in a scorched-earth strategy, Merck hopes that it can win a long endurance game and keep its damages to a minimum. One argument: Philip Morris USA, a unit of Altria Group (nyse: MO - news - people ), has been able to minimize its paid damages related to cigarettes--so why can't Merck try a similar strategy? But some skeptics note that even winning cases costs Merck a huge amount in legal fees, and they argue that eventually, the company will have to settle--the only question is when.
"We know where this is going," says Edward P. Richards, a law professor at Louisiana State University. Both sides, he says, are battling for ground to figure out how to negotiate a settlement. "It's just how we get there."
The cost of the potential verdict could be huge--but it is hard to guess at, given the cases that have so far gone to trial. Merck says it is facing 14,200 Vioxx cases, and that number keeps growing. Timothy Anderson, an analyst at Prudential Equity Group, wrote in a note to investors that if one were to extrapolate from that verdict and the number of cases Merck has so far lost (four of nine tried), the company would be on the hook for $300 billion. Anderson wrote that Merck probably wouldn't pay anything close to that figure...... cut
Vioxx should be allowed back on the market
Linear Mode
