Forbes.com: Merck's Legal Nightmare: "'This is going to be a nightmare of unbelievable proportions in terms of legal liability' for Merck, says independent analyst Hemant Shah of Warren, N.J., who was one of the first to predict that Wyeth (nyse: WYE - news - people ) would face enormous legal liability from its recall of the diet drugs fenfluramine (part of the fen-phen combo) and Redux in 1997." [Forbes]
Friday, October 29, 2004
MSNBC - FDA accused of silencing Vioxx warnings
"WASHINGTON - The Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the Senate Finance Committee said Thursday." [MSNBC]
Times Online - Industry sectors
Times Online - Industry sectors: "Merck directors got $85,000 on day of Vioxx news
"SEVEN directors on the board of Merck received $85,000 in shares on the day that the drugs maker shocked Wall Street with news that it would withdraw Vioxx, The Times has learnt." [The Times Online]
"SEVEN directors on the board of Merck received $85,000 in shares on the day that the drugs maker shocked Wall Street with news that it would withdraw Vioxx, The Times has learnt." [The Times Online]
Forbes.com: Merck's FDA Delay, Pfizer's Problem
Forbes.com: Merck's FDA Delay, Pfizer's Problem: "Merck's FDA Delay, Pfizer's Problem
"NEW YORK - In a capstone to the withdrawal of Vioxx, the U.S. Food and Drug Administration has decided to delay the approval of successor drug Arcoxia until more safety data are available. But the news may not be as much a problem for Arcoxia's maker, Merck, as for rival Pfizer." [Forbes]
"NEW YORK - In a capstone to the withdrawal of Vioxx, the U.S. Food and Drug Administration has decided to delay the approval of successor drug Arcoxia until more safety data are available. But the news may not be as much a problem for Arcoxia's maker, Merck, as for rival Pfizer." [Forbes]
All painkillers similar to Vioxx under scrutiny
NEW DELHI, OCTOBER 22: After making public the ban on Merck’s arthritis drug Vioxx (Rofecoxib), the Central government today took decision on other coxib drugs belonging to same class of selective Cox-2 inhibitors. It has initiated a National Pharmacovigilance Programme to scrutinise these drugs and collect data on their side-effects.
In its first meeting held on October 11, the National Pharmacovigilance Advisory Committee had, apart from banning Vioxx, cautioned against the use of other drugs in the same class and said ‘‘their use in patients with coronary heart disease/cardiovascular disease be stopped by appropriate labeling changes’’. The related drugs are celecoxib, parecoxib, valdecoxib.
In its first meeting held on October 11, the National Pharmacovigilance Advisory Committee had, apart from banning Vioxx, cautioned against the use of other drugs in the same class and said ‘‘their use in patients with coronary heart disease/cardiovascular disease be stopped by appropriate labeling changes’’. The related drugs are celecoxib, parecoxib, valdecoxib.
Sunday, October 24, 2004
Friday, October 22, 2004
FDA Public Health Advisory: Safety of Vioxx
FDA Public Health Advisory: Safety of Vioxx
Sept. 30, 2004 - Merck & Co., Inc. today announced a voluntary withdrawal of Vioxx from the U.S. market due to safety concerns. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. . . .
. . . Patients who are currently taking Vioxx should contact their physician for guidance regarding discontinuation and alternative therapies.
Thursday, October 21, 2004
Failing the Public Health — Rofecoxib, Merck, and the FDA
"On May 21, 1999, Merck was granted approval by the Food and Drug Administration (FDA) to market rofecoxib (Vioxx). On September 30, 2004, after more than 80 million patients had taken this medicine and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes. This represents the largest prescription-drug withdrawal in history, but had the many warning signs along the way been heeded, such a debacle could have been prevented.
"Neither of the two major forces in this five-and-a-half-year affair — neither Merck nor the FDA — fulfilled its responsibilities to the public. The pivotal trial for rofecoxib involved 8076 patients with rheumatoid arthritis and demonstrated that this coxib had lower gastrointestinal toxicity than naproxen"
New England Journal of Medicine, October 21, 2004
"Neither of the two major forces in this five-and-a-half-year affair — neither Merck nor the FDA — fulfilled its responsibilities to the public. The pivotal trial for rofecoxib involved 8076 patients with rheumatoid arthritis and demonstrated that this coxib had lower gastrointestinal toxicity than naproxen"
New England Journal of Medicine, October 21, 2004
Friday, October 15, 2004
The FDA announcement is not surprising.
The FDA announcement is not surprising. In Merck's Vioxx Gastrointestinal Outcomes Research report published in the New England Journal of Medicine (November 23, 2000), Merck compared the effectiveness of Vioxx (rofecoxib) to naproxen. The study shows a statistically significant increase in heart attacks in the rofecoxib group (0.5 percent) compared to the naproxen group (0.1 percent). There were 20 heart attacks suffered by 4,047 Vioxx patients and 4 heart attacks in 4,029 naproxen patients. While the absolute numbers are low, this is a five-fold increase that statistically is highly significant and merited further studies. In addition the study reported increased problems with blood clotting that results in strokes and leg clots.
The drug has been on the market around the world since about 1999 and has been prescribed millions of times...More info here: http://www.alexanderlaw.com/vioxx/
Wednesday, October 06, 2004
FDA STUDY ESTIMATES VIOXX LINKED TO 27,000 HEART ATTACKS.
A study led by a Food and Drug Administration safety official projects that the widespread use of Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths before the drug's abrupt withdrawal last week by Merck & Co. (MRK), according to an October 6, 2004 Wall Street Journal report.
CNN Money, October 6, 2004.
Saturday, October 02, 2004
MERCK'S CONFLICT OF INTEREST.
Dr. Topol said that "despite studies showing the magnitude of the public health problem, for several years Merck did nothing to investigate. This surely represents a conflict between the interests of the public and the interests of the company. Instead of doing the requisite research in patients with heart disease - who frequently have arthritis as well and are thus prime users of anti-inflammatory medicines - the company undertook studies that avoided them. At the same time Merck spent at least $100 million a year for direct-to-consumer Vioxx advertising, while the company's employees and their consultants published several papers in medical journals rebutting studies reporting Vioxx's heart attack risk."
New York Times, October 2, 2004.
New York Times, October 2, 2004.
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