Is Merck as bad as it is made out to be?

In the ongoing trial in Angleton, Texas, in the Vioxx lawsuit filed by Carol Ernst, her attorney Mark Lanier has painted Merck as a company driven by greed – profits at any cost, even deaths of over 50,000 Americans and an estimated 140,000 personal injuries. So is Merck really such a bad company while it says “Where patients come first?”

Lanier argues that Merck became a greedy company in 1994 when Raymond Gilmartin took the reins of the company. Pharmaceutical companies that do a lot of research work have traditionally been headed by scientists. But Gilmartin had no background in drugs. And as the chart below shows, the company embarked on an aggressive growth path and the focus was on the stock price even if it meant taking huge risks and playing with the lives of patients. After the mishandling of recall of Vioxx, Gilmartin was fired. Gilmartin also relied on politican connections with Washington Republicans to make sure that no one touched Merck. He was a big contributor to President Bush as well.

A chart showing the financial performance of Merck since 1994 when Raymond Gilmartin took over and when Vioxx was recalled.

Lanier also accuses Merck of hiding risks of Vioxx. Since the Vioxx controversy erupted last year, enormous evidence has emerged that not only did Merck not disclose the dangers of Vioxx, it also used data selectively to blow up the benefits and downplay the risks.

Lanier points out that Merck spent a billion dollar to market Vioxx. A little background on the pharma industry is going to be helpful here. Due to the high cost of doing business in the US, drug development cost approaches $850 million from concept to commercialization. That is why when a drug achieves a billion dollar in sales it is considered a “blockbuster.” Hence, for Merck to spend a billion dollars on marketing alone was somewhat unusual, but it also showed how Merck was able to push a dangerous drug to doctors and patients through slick marketing. Merck had an army of almost 5,000 salespeople for Vioxx whose job was to sell it at any cost and avoid any questions about the safety of the drug.

Finally, Lanier also accuses doctors who often get treated like celebrities by drug firms so that they would prescribe their medicines. That is exactly what Merck was doing. It not only intimidated Vioxx critics but made sure that doctors were so well treated by its salespeople that they would simply prescribe Vioxx and ask no questions.

More revelations are likely in the case as the trial continues for several weeks.

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As the jury of five women and seven men is seated in Angleton, Texas, and opening arguments begin today in the Vioxx lawsuit brought by widow Carol Ernst, she may have some help from a non-profit health organization that conducts clinical research studies, opposes unethical human experimentation, and promotes alternatives to animal research. Physicians Committee for Responsible Medicine (PCRM) has filed a lawsuit alleging that Merck wrongfully relied on tests showing Vioxx was safe in animals while ignoring mounting evidence that the drug is dangerous to humans. This is believed to be the first time a U.S. pharmaceutical company has been sued specifically for relying on animal tests to show incorrectly that the drug was safe for humans. (Related article: Merck knew of Vioxx risks but decided to hide them)

The lawsuit charges that Merck was well aware of the limitations of animal testing — that animal studies are often inconsistent, species-dependent, and not useful in predicting drug safety or efficacy in humans. At least nine of 11 mice and rat studies, for example, showed Vioxx to be beneficial for animal hearts. The suit accuses Merck of using these and other inapplicable animal data to justify keeping Vioxx on the market. It also states that Merck knew of more effective safety assessment methods, such as postmarket surveillance of patient reactions, in vitro tests using human cells and tissues, and computer modeling, but failed to employ these methods. (Related article: Merck did not disclose dangers of Vioxx)

Such practices are commonly used in the United States by drug companies that often rely on doubtful statistics to get faster approval from the FDA. The agency, many experts charge, is in bed with the drug industry, and simply ignores what the pharmaceutical firms do. Senator Chuck Grassley has been working hard to make the FDA focus more on saving the lives of American people rather than help the drug companies market dangerous drug. Dr. David Graham, an expert at the FDA, has repeatedly accused the agency of favoring drug companies over American people. (Related article: FDA incapable of ensuring drug safety in America)

Vioxx was recalled last year after enormous amount of evidence was available that showed that the drug should be on the market. Up to 60,000 Americans may be dead after taking Vioxx, according to FDA estimates. Merck is facing over 100,000 Vioxx related lawsuits, and the latest suit from PCRM carries more weight because of the amount of scientific evidence that is being presented. At a news conference, Dallas-based cardiologist John Pippin, shared the results of his research, including a new “smoking gun.” Dr. Pippin presented data from an unpublished study on African green monkeys that Merck used as additional evidence of Vioxx’s supposed safety. (Related article: Merck hid risk of death from Vioxx)

“Merck endangered public health by relying on inapplicable animal tests rather than relevant and available human data,” says Dan Kinburn, PCRM associate general counsel. The injured plaintiff, Nancy Tufford, a PCRM member from Minnesota, is seeking $1 million in damages because she developed congestive heart failure while taking Vioxx.

The trial in Texas, expected to last five weeks, is likely to be closely watched by Vioxx victims. While the outcome may have only minimal impact on how other lawsuits are decided, the knowledge that Vioxx lawyers gain from the trial will be helpful in building more solid evidence in future trials. Merck has vowed not to settle any Vioxx litigation out of court and has announced that it intends to fight each lawsuit individually.

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There is more bad news for users of Cox-2 inhibitor drugs (that includes now withdrawn drugs Vioxx and Bextra, and Celebrex, that is still available but carries a black box warning) and NSAIDs. According to research completed by Dutch scientists, risk of acute urinary retention (AUR) was twofold higher in current users of NSAIDs than in non-users. The highest risk for AUR was observed in patients who recently started using NSAIDs and in those using a dose equal to or higher than the recommended daily dose. AUR is characterized by the sudden inability to urinate, which is usually extremely painful and requires catheterization. (Related article: Risks of NSAIDs)

Cox-2 drugs and many painkillers have been under the spotlight after Vioxx was recalled in September 2004 by Merck. The FDA estimates that as many as 140,000 Americans were injured after taking Vioxx, while 50,000-60,000 Americans are dead. Since then Merck has been facing a barrage of lawsuits. The first ever Vioxx trial began this week in the case of Carol Ernst. It is estimated that Vioxx litigation could include over 100,000 lawsuits. (Related article: Documents prove that Merck hid Vioxx risks)

Katia Verhamme, Jeanne Dieleman, Marc Van Wijk, Johan van der Lei, Joseph Bosch, Bruno Stricker, and Miriam Sturkenboom conducted a population based case-control study. While the FDA has already warned about indiscriminate use of over-the-counter NSAID drugs, Canadian scientists went as far as arguing that Ibuprofen may be as dangerous as Vioxx.

Since the recall of Vioxx and Bextra, prescriptions for Celebrex have dropped significantly as arthritis patients have switched to alternative treatments. No data is yet available how these reports will impact sales of NSAIDs, but it appears that patients may seek more natural alternatives for pain relief.

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