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:
Glossary of Truck Related TermsWritten by Michael Monheit, Esquire, Monheit Law, PC
Axle Structural component to which wheels, brakes, and suspension is attached. Drive axles are those with powered wheels. Front axle is usually called steer axle. Pusher axles are not powered and go ahead of drive axles. Rear axles may be drive, tag, or pusher types. Tag axles are not powered and go behind drive axles. Axes may lock causing truck accidents.
Blind Spot Areas around a commercial vehicle not visible to driver either through windshield, side windows, or mirrors; a common cause of truck accidents
Cargo Weight The combined weight of all loads, gear, and supplies on a commercial truck or rig.
Common Carrier A freight transportation company that regularly serves general public with route service over designated highways. Or irregular routes between various points on an unscheduled basis.
Dead-Heading Operating a truck without cargo; when an oil tanker is not full, sloshing creates a dangerous situation conducive to truck accidents.
Drivetrain (Powertrain) All components, excluding engine, which transmit engine's power to rear wheels: clutch, transmission, driveline and drive axle(s)
GAWR (Gross Axle Weight Rating) Maximum weight an axle is rated to carry by manufacturer includes both weight of axle and portion of a vehicle's weight carried by axle.
GCW (Gross Combination Weight) Total weight of a loaded combination vehicle, such as a tractor-semi-trailer or truck and full trailer(s)
Grade Steepness of a grade, expressed as a percentage. Example: A vehicle climbing a 5% grade rises 5 feet for every 100 feet of forward travel.
GVW (Gross Vehicle Weight) Total weight of a vehicle and everything aboard, including its load; could be an important piece of evidence in a truck accident.
GVWR (Gross Vehicle Weight Rating) Total weight a vehicle is rated to carry by manufacturer, including its own weight and weight of its load.
Hazmat Hazardous materials, as classified by U.S. Environmental Protection Agency (EPA). Transport of hazardous materials is strictly regulated by U.S. Department of Transportation.