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VIOXX, 55,000 die because of politicians

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Second article at bottom confirms deaths, also Naproxin is reponsible for a 15% rise in caronaries (another study place it at 40%).
 

 

 

This is undoubted the greatest disaster this nation has undergone.  When all the related drugs are counted there will be over 100,000 deaths and more than 300,000 stricken.  Yet our conservative bias, pro-government news fails to make much of this issue.  The shuttle explosion has received several fold more air time. 

 

 

 

Drug Safety at the FDA Under Fire: What to Do?

Criticism of FDA's Drug Safety Efforts Triggers Debate



 

 

Aside from criticizing the FDA for not acting sooner to protect Americans from the potential risks associated with Vioxx, Graham also warned that five additional popular prescription drugs should be closely monitored due to safety concerns. Graham fingered Crestor, Bextra, Meridia, Serevent, and Accutane in his statement…. During his testimony, Graham, who is an associate science director at the FDA's Office of Drug Safety, said that the recommendations of drug safety reviewers are often overruled by officials in the FDA's Office of New Drugs. He asked lawmakers to create an independent drug safety monitoring office free of the influence from regulators who approve new drugs.

But Galson says the FDA's Office of New Drugs is already an independent office and is separate from the office that reviews drug safety. Both offices report to Galson, as the acting director of the Center for Drug Evaluation and Research.

To address post-approval drug safety concerns, Galson says he recently asked the Institute of Medicine (IOM) to look at the structure of the FDA's post-marketing surveillance program and to give their advice on whether additional changes are needed to the agency's approach to drug safety.

This is a bureaucratic response, one which before all else defends the agency.  That leaves us with two concerns:  (1) is the IOM an independent, credible agency, and (2) is it likely that their recommendations if critical of the existing structure will be implemented?  The answer to the first is a qualified yes, for it is funded by Congress, and as for (2).  There are too many political loops to jump including a President who is in bed with the pharmaceutical industry, as is Congress, and Galson will surely oppose a review system outside the FDA, for bureaucrats always defend their turf.   Finally studies are the do-something, do-nothing dodge.  In a couple of years a report will be generated by the IOM and reviewed, and by that time Congress, the President, and the public will have forgotten the cause for the study.  Skepticism is further reinforced by the track record of the FDA, which has consistently been pro-pharameutical industry.  The chances for significant in the public’s interest action is slim, while the pretend concern and pretend we are doing something has already started.  History is repeating itself. 

 

Vioxx: 160,000 Heart Attacks and Strokes

This call for safety studies has a familiar ring to it. In August 2001, Eric J. Topol, MD, chairman of the Cleveland Clinic cardiology department, was troubled by heart-safety data in Vioxx clinical trials. He called on the FDA to demand specially designed heart-safety studies. That never happened. Instead, three years later, a study looking at whether Vioxx could prevent colon polyps found the drug posed an unacceptably high heart risk.

Ten million people have taken Vioxx, partly due to an aggressive direct-to-consumer advertising campaign. Topol calculates that 160,000 of these patients had a Vioxx-caused heart attack or stroke.

 

Statement by Sidney M. Wolfe, MD, Director of Public Citizen’s Health Research Group, Concerning Withdrawal of Vioxx From the Market

Today’s announcement by Merck is the latest evidence that this family of drugs, the Cox-2 inhibitors, once referred to as “super aspirins,” are turning out to be more like super disasters. As discussed below, there are safety problems with Celebrex as well as Bextra, the two other big-selling Cox-2 inhibitors   that are the most-prescribed alternatives to Vioxx.

In trying to appear “a good citizen,” Merck ignores its checkered history with Vioxx. In today’s statement announcing the withdrawal of Vioxx from the market, Peter S. Kim, Ph.D., president of Merck Research Laboratories asserted that “Merck has always believed that prospective, randomized, controlled clinical trials are the best way to evaluate the safety of medicines.” Yet after an earlier randomized trial, the VIGOR study, published almost four years ago (November 2000), that found Vioxx caused a four- to five-fold increase in heart attacks, Merck received, on Sept. 17, 2001, a warning letter from the U.S. Food and Drug Administration (FDA) because the company’s ads for the drug failed to mention this increased risk of heart attacks. In the eight-page warning letter addressed to Merck President and CEO Raymond V. Gilmartin, the FDA stated:

You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen).

In Merck’s VIGOR study, comparing rofecoxib to naproxen, there was a highly statistically significant five-fold increase in heart attacks in the overall rofecoxib {VIOXX} group (0.5 percent) compared to the naproxen group (0.1 percent). This amounted to 20 heart attacks with rofecoxib (out of 4,047 patients) compared with four with naproxen (out of 4,029 patients). This increased number of heart attacks was also accompanied by an increase in other thrombotic (blood clotting) adverse effects such as strokes and blood clots in the legs as well as problems with hypertension in the rofecoxib group compared with the naproxen group.

 

 

Vioxx May Have Caused 140,000 Heart Attacks


Jan 26 '05



Food and Drug Administration safety reviewer David Graham estimates that Merck's Vioxx may have caused as many as 140,000 heart attacks in the U.S. before it was withdrawn last September. His estimate was published in the British medical journal Lancet.

The study was based on records of 1.4 million members of Kaiser Permanente, the largest U.S. nonprofit insurer, with 6 million members in California. Many of the cases may have been fatal, Graham said.

A Merck spokesman said the estimate of harm from Vioxx was "speculation." Determinations of Vioxx's potential role in patients' cardiovascular problems "can only be made on a case by case basis," he said.

The publication of Graham's findings is expected to intensify the drug-safety debate that has swept Washington since the Vioxx withdrawal. Graham and other critics accuse the FDA of being too slow to ban or tighten regulations on medicines that cause serious side effects.

Researchers compared the incidence of heart attacks and sudden cardiac death for patients taking Vioxx with those on Pfizer's Celebrex, a similar painkiller, and over-the-counter medications.

Applying the findings across the U.S. population, "We arrived at the estimate of 88,000 to 140,000 patients that had a heart attack in the U.S. because they used Vioxx" after it was introduced in 1999, Graham said.

Portions of the study had been disclosed earlier. Graham said in Nov. 18 testimony before the Senate Finance Committee that between 88,000 and 139,000 heart attacks may have been linked to Vioxx.

Merck withdrew Vioxx after a company study showed that patients taking it for 18 months or longer had twice the risk of heart attacks and strokes -- 1.5 percent -- as those taking a placebo.

Graham said his bosses at the FDA at one point threatened to fire him as associate director for science and medicine in the agency's Office of Drug Safety if he published the findings.

The study found that Vioxx, given at the standard dose, increases the risk of heart attack by about 50 percent, compared with Pfizer's Celebrex, and more than triples the risk of heart attacks when given at high doses. The two drugs suppress the body's production of the Cox-2 enzyme, which is linked to pain and swelling.

People taking Vioxx had a 34 percent higher chance of heart disease compared with those taking other painkillers including Celebrex, naproxen and ibuprofen, the study found.

Patients taking naproxen, a generic painkiller sold as Aleve by Bayer AG, had a 14 percent increase in heart risk compared with some other painkillers such as ibuprofen, the study showed. Previous trials had suggested naproxen may protect against cardiac disease.




Copyright 2003-2005 ConsumerAffairs.com Inc. All Rights Reserved.

 

healthfully.org is devoted primarily to medical issues, and /medicalcrap is devoted exposing how profits corrupt medical science.  There are articles on VIOXX, suppression of results, how to generate bad data, links, etc.

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