Vioxx side effects confirmed in another study
In a report titled "The Risk for Myocardial Infarction with Cyclooxygenase-2 Inhibitors: A Population Study of Elderly Adults," published in the Annals of Internal Medicine, the authors L.E. Lévesque, J.M. Brophy, and B. Zhang, find that people prescribed rofecoxib (Vioxx) had a 1.24 higher relative risk for heart attack compared to those prescribed no NSAIDs. Higher doses of rofecoxib were associated with higher risks. Concomitant aspirin use lessened the risks associated with low-dose, but not high-dose, rofecoxib. (Related article: Vioxx doubled risk of heart attacks)
Celecoxib (Celebrex), meloxicam (Mobicox), and the other NSAIDs were not associated with increased risk for heart attack. The researchers studied 113,927 adults older than 65 years of age in Québec, Canada. (Related article: Merck argues that both Vioxx and Celebrex have same risks)
Apart from confirming that Vioxx did lead to higher rate of heart attack, something that Merck continues to deny, this study has other implications as well. Some nonselective NSAIDs and COX-2 inhibitors (e.g. Celebrex, Bextra, Arcoxia, etc.), other than Vioxx, might not increase the risk for a heart attack, the study found. In other words, it is a strong endorsement of the position of Vioxx victims who are involved in litigation with Merck but victims of Celebrex and Bextra will need to rely on several other studies to support their argument. (Related article: Celebrex class action lawsuits)
Doctors agree that Vioxx, Celebrex, and Bextra do have a few benefits but they also bring many other risks with them. In an excellent article, Robert A. Greenwald, M.D., Professor of Medicine at Albert Einstein College of Medicine, says, "Aggressive marketing by the manufacturers of the COX-2 drugs backfired into the current controversy. The drugs were originally intended only for high-risk populations, e.g., the elderly, those with prior gastrointestinal events, etc. A forty-year old male with a tennis elbow and no ulcer history was not the target population for these drugs. Over-enthusiasm for prescribing the COX-2 drugs has now backlashed into over-avoidance. Had the COX-2 agents been restricted to the populations for which they were originally intended, they might still be enjoying widespread use, and their potential for other, lifesaving indications would still be under exploration, and not on the shelf. Let us hope the recent FDA decision to keep the drugs on the market enables their most beneficial uses to continue, including any yet to be discovered." (Related article: Will you take Vioxx if it returns?)
In the meantime, Merck continues to struggle as a company. The management has essentially dealt with the problem by violating what it touts as its guiding principles, that is, "dedicated to putting patients first" and "Committed to bringing out the best in medicine." It has refused to accept any responsibility whatsoever for the estimated 140,000 deaths and injuries from Vioxx. It has laid off thousands of employees after Vioxx recall and continues to be in denial about the challenges that it faces. In a study by Vault (a company that tries to find out the "insider" information for prospective employees), finds that, "Employee morale at Merck is said to be at an all time low following the layoff of 5,200 employees and the withdrawal of Vioxx, one of the company's largest drugs. Blockbusters are coming off patent and there are no visible replacements in the pipeline. Employee turnover has more than doubled."
No wonder then that the FDA has not given a green signal yet to Merck to sell Vioxx again and has simply indicated that it will evaluate Merck's request to do so. It seems highly unlikely that Vioxx will be back on the market considering that Bextra recall has been announced by the FDA and Celebrex will carry a black-box warning.
Recommended articles
Merck finally admits that it might have liabilities related to Vioxx recall
Merck still refuses to settle Vioxx lawsuits out of court
Useful links
Annals of Internal Medicine
Albert Einstein College of Medicine
Vault
Celecoxib (Celebrex), meloxicam (Mobicox), and the other NSAIDs were not associated with increased risk for heart attack. The researchers studied 113,927 adults older than 65 years of age in Québec, Canada. (Related article: Merck argues that both Vioxx and Celebrex have same risks)
Apart from confirming that Vioxx did lead to higher rate of heart attack, something that Merck continues to deny, this study has other implications as well. Some nonselective NSAIDs and COX-2 inhibitors (e.g. Celebrex, Bextra, Arcoxia, etc.), other than Vioxx, might not increase the risk for a heart attack, the study found. In other words, it is a strong endorsement of the position of Vioxx victims who are involved in litigation with Merck but victims of Celebrex and Bextra will need to rely on several other studies to support their argument. (Related article: Celebrex class action lawsuits)
Doctors agree that Vioxx, Celebrex, and Bextra do have a few benefits but they also bring many other risks with them. In an excellent article, Robert A. Greenwald, M.D., Professor of Medicine at Albert Einstein College of Medicine, says, "Aggressive marketing by the manufacturers of the COX-2 drugs backfired into the current controversy. The drugs were originally intended only for high-risk populations, e.g., the elderly, those with prior gastrointestinal events, etc. A forty-year old male with a tennis elbow and no ulcer history was not the target population for these drugs. Over-enthusiasm for prescribing the COX-2 drugs has now backlashed into over-avoidance. Had the COX-2 agents been restricted to the populations for which they were originally intended, they might still be enjoying widespread use, and their potential for other, lifesaving indications would still be under exploration, and not on the shelf. Let us hope the recent FDA decision to keep the drugs on the market enables their most beneficial uses to continue, including any yet to be discovered." (Related article: Will you take Vioxx if it returns?)
In the meantime, Merck continues to struggle as a company. The management has essentially dealt with the problem by violating what it touts as its guiding principles, that is, "dedicated to putting patients first" and "Committed to bringing out the best in medicine." It has refused to accept any responsibility whatsoever for the estimated 140,000 deaths and injuries from Vioxx. It has laid off thousands of employees after Vioxx recall and continues to be in denial about the challenges that it faces. In a study by Vault (a company that tries to find out the "insider" information for prospective employees), finds that, "Employee morale at Merck is said to be at an all time low following the layoff of 5,200 employees and the withdrawal of Vioxx, one of the company's largest drugs. Blockbusters are coming off patent and there are no visible replacements in the pipeline. Employee turnover has more than doubled."
No wonder then that the FDA has not given a green signal yet to Merck to sell Vioxx again and has simply indicated that it will evaluate Merck's request to do so. It seems highly unlikely that Vioxx will be back on the market considering that Bextra recall has been announced by the FDA and Celebrex will carry a black-box warning.
Recommended articles
Merck finally admits that it might have liabilities related to Vioxx recall
Merck still refuses to settle Vioxx lawsuits out of court
Useful links
Annals of Internal Medicine
Albert Einstein College of Medicine
Vault
posted by eCreativa Media | 2:59 PM
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