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 studyrepparttar cardiac impact -- rather only when it had an opportunity to add a new market forrepparttar 119247 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 whatrepparttar 119248 public should have known and Merck already did know sooner... In May 1999repparttar 119249 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) torepparttar 119250 FDA that found an increased risk of Vioxx heart attacks and strokes in patients taking Vioxx compared to patients taking naproxen. After reviewingrepparttar 119251 VIGOR study results and other available data from controlled clinical trials,repparttar 119252 FDA consulted with its Arthritis Advisory Committee in February 2001 regardingrepparttar 119253 clinical interpretation of this new questionable Vioxx-related information. Perhaps, back in Feb of 2001, it was "questionable," butrepparttar 119254 "question" aboutrepparttar 119255 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 alertrepparttar 119256 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 arerepparttar 119257 jury, that there were $2.5 Billion reasons each year that they did not look further atrepparttar 119258 heart attack issue for years. On September 17, 2001 (and, to Merck’s good fortune, lost inrepparttar 119259 news ofrepparttar 119260 terrorist attacks of 9/11),repparttar 119261 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 minimizesrepparttar 119262 potentially serious cardiovascular findings that were observed inrepparttar 119263 VIOXX Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresentsrepparttar 119264 safety profile for VIOXX. Specifically, your promotional campaign discountsrepparttar 119265 fact thatrepparttar 119266 VIGOR study patients on VIOXX were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients onrepparttar 119267 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 ofrepparttar 119268 Pharma industry, in release T02-18 (4/11/2002) required Merck to labelrepparttar 119269 drug as a cardiac risk.

"FDA has approved a supplemental application forrepparttar 119270 use of Vioxx (rofecoxib) for rheumatoid arthritis addingrepparttar 119271 indication torepparttar 119272 previously approved indications for osteoarthritis and pain. FDA has also approved new label text and precautions that are based onrepparttar 119273 results ofrepparttar 119274 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 (twicerepparttar 119275 highest approved dose for chronic use) and approximately 4000 patients onrepparttar 119276 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 fromrepparttar 119277 study.... An additional finding inrepparttar 119278 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) inrepparttar 119279 Vioxx group (1.8%) compared torepparttar 119280 naproxen group (0.6%). Data from two smaller studies comparing placebo and Vioxx 25 mg daily did not show a difference inrepparttar 119281 rate of serious cardiovascular thromboembolic adverse events. The relationship ofrepparttar 119282 cardiovascular findings inrepparttar 119283 VIGOR study to use of Vioxx is not known. After carefully reviewingrepparttar 119284 results ofrepparttar 119285 VIGOR Study, FDA agreed withrepparttar 119286 Arthritis Advisory Committee recommendations of February 8, 2001 thatrepparttar 119287 label for Vioxx should includerepparttar 119288 gastrointestinal and cardiovascular information. The committee advised thatrepparttar 119289 NSAID-class warning regarding GI adverse events should be modified, but not removed fromrepparttar 119290 VIOXX label. This warning advises patients and their doctors aboutrepparttar 119291 risks of GI ulcers, bleeding, and perforation. " That is an increase over over 1 in 100 people who takerepparttar 119292 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 torepparttar 119293 more recent study. Only when they saw gold in their pockets, selling Vioxx intorepparttar 119294 cancer prevention market, did Merck dorepparttar 119295 study. Only this timerepparttar 119296 study turned out to confirm what they already "suspected" in June 2000, but failed to actually study it. Atrepparttar 119297 very least, they should have done further study three years ago forrepparttar 119298 specific problem that they subsequently confirmed inrepparttar 119299 more recent study. This attitude simply ignoredrepparttar 119300 mounting evidence that VIOXX was, indeed,repparttar 119301 killer it had always been suspected of being. This is allrepparttar 119302 more obvious when one considersrepparttar 119303 following facts:

Glossary of Truck Related Terms

Written 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 calledrepparttar 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 torepparttar 119246 driver either throughrepparttar 119247 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 servesrepparttar 119248 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,repparttar 119249 sloshing creates a dangerous situation conducive to truck accidents.

Drivetrain (Powertrain) Allrepparttar 119250 components, excluding engine, which transmitrepparttar 119251 engine's power torepparttar 119252 rear wheels: clutch, transmission, driveline and drive axle(s)

GAWR (Gross Axle Weight Rating) Maximum weight an axle is rated to carry byrepparttar 119253 manufacturer includes bothrepparttar 119254 weight ofrepparttar 119255 axle andrepparttar 119256 portion of a vehicle's weight carried byrepparttar 119257 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 byrepparttar 119258 manufacturer, including its own weight andrepparttar 119259 weight of its load.

Hazmat Hazardous materials, as classified byrepparttar 119260 U.S. Environmental Protection Agency (EPA). Transport of hazardous materials is strictly regulated byrepparttar 119261 U.S. Department of Transportation.

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