What are the Alternatives to Vioxx?Written by Michael Monheit, Esquire, Monheit Law, PC
With withdrawal of Vioxx from pharmaceutical market, doctors and patients are left scrambling for alternatives to Vioxx. PLEASE CONSULT YOUR PHYSICIAN FOR INFORMATION ON MEDICATIONS AND ALTERNATIVES TO VIOXX. The below is only informational, and is not offered as medical advice! Only your doctor can determine what pain killers will be right for you. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for relief of osteoarthritis, for menstrual symptoms, and management of acute pain in adults. Pain relievers called NSAIDs, work against two enzymes -- COX-1 and COX-2 -- that frequently cause inflammation and pain. Cox-1 is found in stomach and Vioxx and its alternatives that attack it often cause upset stomachs and ulcers. Vioxx and Vioxx alternatives are known as a class of drugs called COX-2 inhibitors attack that sole enzyme, minimizing stomach side effects. Are other alternatives to Vioxx safe? COX-2 drugs have tendency to raise blood pressure, but only Vioxx has been linked to a higher risk of heart attack, stroke, and other cardiovascular problems. Although there is now study showing that some alternatives to Vioxx also cause heart problems. For example, study released in October 2004 regarding Bextra and heart surgery patients. Two COX-2 inhibitor alternatives to Vioxx are sold in U.S. – Celebrex and Bextra. However, safety has of these altnernatives to Vioxx been questioned. Drug manufacturers – Pharmacia and Pfizer have huge advertising budgets and sales in millions.
| | Why am I mad at Merck over Vioxx?Written by Michael Monheit, Esquire, Monheit Law, PC
What is disturbing to me, is that given years of evidence that there was a risk of stroke and heart attack from Vioxx, Merck did NOT set out to study cardiac impact -- rather only when it had an opportunity to add a new market for drug did they do a study which accidentally caused Merck to acknowledge publicly what it already knew privately. This study, and only by "accident" turned out to thte public what public should have known and Merck already did know sooner... In May 1999 Food and Drug Administration (FDA) approved Vioxx. The original safety database included approximately 5,000 patients on Vioxx and did not show an increased risk of heart attack, stroke, blood clots, or sudden death. One year later in June 2000, Merck submitted a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) to FDA that found an increased risk of Vioxx heart attacks and strokes in patients taking Vioxx compared to patients taking naproxen. After reviewing VIGOR study results and other available data from controlled clinical trials, FDA consulted with its Arthritis Advisory Committee in February 2001 regarding clinical interpretation of this new questionable Vioxx-related information. Perhaps, back in Feb of 2001, it was "questionable," but "question" about lack of safety for Vioxx was squarely put forth to Merck, and Merck had a moral obligation, not to mention and financial obligation to its shareholders, to look further into this -- THEN. They did not. Why not? -------- Why did it take 22 months (June 2000 to Feb 2001) to alert medical community and its patients about life threatening risks for Vioxx induced chest pain, heart attacks, blood clots, stroke, and sudden death? ... I would argue, and yes, this is me with my attorney hat on and you are jury, that there were $2.5 Billion reasons each year that they did not look further at heart attack issue for years. On September 17, 2001 (and, to Merck’s good fortune, lost in news of terrorist attacks of 9/11), FDA issued an 8-page warning letter to Merck concerning its false and misleading promotional campaign. The FDA found: “You have engaged in a promotional campaign that minimizes potentially serious cardiovascular findings that were observed in VIOXX Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents safety profile for VIOXX. Specifically, your promotional campaign discounts fact that VIGOR study patients on VIOXX were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen).” So. finally, in April 2002, after "foot dragging" (you'd call it due diligence or appropriate caution) an FDA that is stacked with folks coming in and out of Pharma industry, in release T02-18 (4/11/2002) required Merck to label drug as a cardiac risk. "FDA has approved a supplemental application for use of Vioxx (rofecoxib) for rheumatoid arthritis adding indication to previously approved indications for osteoarthritis and pain. FDA has also approved new label text and precautions that are based on results of Vioxx Gastrointestinal Outcomes Research (VIGOR). The VIGOR study, a prospective, randomized, double-blind, one year study, evaluated approximately 4000 patients on Vioxx 50 mg a day (twice highest approved dose for chronic use) and approximately 4000 patients on standard dose of naproxen (1000 mg a day), a non-steroidal anti-inflammatory drug (NSAID). Patients who were under treatment with low dose aspirin for heart attack prevention were excluded from study.... An additional finding in study, however, was that there was a higher cumulative rate of serious cardiovascular thromboembolic adverse events (such as heart attacks, angina pectoris, and peripheral vascular events) in Vioxx group (1.8%) compared to naproxen group (0.6%). Data from two smaller studies comparing placebo and Vioxx 25 mg daily did not show a difference in rate of serious cardiovascular thromboembolic adverse events. The relationship of cardiovascular findings in VIGOR study to use of Vioxx is not known. After carefully reviewing results of VIGOR Study, FDA agreed with Arthritis Advisory Committee recommendations of February 8, 2001 that label for Vioxx should include gastrointestinal and cardiovascular information. The committee advised that NSAID-class warning regarding GI adverse events should be modified, but not removed from VIOXX label. This warning advises patients and their doctors about risks of GI ulcers, bleeding, and perforation. " That is an increase over over 1 in 100 people who take drug having a heart attack because of it. Pretty statistically significant. It means that we both probably know someone who this happened to. OK, now fast forward to more recent study. Only when they saw gold in their pockets, selling Vioxx into cancer prevention market, did Merck do study. Only this time study turned out to confirm what they already "suspected" in June 2000, but failed to actually study it. At very least, they should have done further study three years ago for specific problem that they subsequently confirmed in more recent study. This attitude simply ignored mounting evidence that VIOXX was, indeed, killer it had always been suspected of being. This is all more obvious when one considers following facts:
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