Drug Studies Being Produced by Ghostwriters

Marketing and Science are Basically the Same Anyway, Right?

Inebriated Press
April 25, 2008

Daily News Central reported earlier this week that much of the research supporting Merck’s claims about the drug Vioxx were written by Merck’s own employees and then rubber-stamped by medical professionals to heighten their profiles. While that disturbs some experts who feel that Merck’s employees may be biased in favor of their employers’ drugs, others see it as a very efficient combination of sales and marketing with research and medical science.

“When the people who study the risks and benefits of medication that the Food and Drug Administration (FDA) relies on are the same ones that develop the drugs and market them, it makes approval of the drugs much quicker and marketing and promotion faster and more effective,” said Nazi Informer, an FDA official who moonlights as a pharmaceutical rep and believes that independent inquiry is overrated. “Sure Vioxx ended up killing some people but it helped relieve their pain. It’s an aggressive cure I admit and we lost some good customers, but customer complaints went way down. Of course their remaining relatives got excited and sued us. They just didn’t understand.”

Not everyone thinks that Merck was behaving ethically when they did what they did. “You can’t have the manufacturer in charge of the study that verifies their products safety, with the exception of the U.S. food supply that’s crazy,” said a confused U.S. food inspector who spot checks things on occasions but relies on most food companies to police themselves because it’s less costly and more efficient. “Sure we only check 1% of all imported food, but that’s okay. Drugs are a different matter, there’s lots of money involved. You’ve got to make sure only the right people get it. I mean, it’s important that drugs are safe. Yah, that’s it.”

Daily News Central reported that the latest insult piled onto all the injury inflicted by the Vioxx debacle is disclosed in an article published by the Journal of the American Medical Association earlier this month: Much of the research backing up manufacturer Merck’s claims about the drug was ghostwritten by writers in Merck’s employ and then rubber-stamped by medical professionals who had little or no involvement in the studies but were willing to attach their names as authors nonetheless. Though the information came to light in connection with lawsuits over Vioxx, experts say the practice is not unique to Merck. Ghostwriting medical research is common in the pharmaceutical industry, according to many insiders. The issue has taken on graver importance because the FDA is considering whether to allow the dissemination of articles that appear in peer-reviewed journals to physicians as tools to guide them in deciding whether or not to prescribe a particular drug to a patient for an off-label use.

Late last year Merck & Co. agreed to pay $4.85 billion to settle thousands of cases brought by people who suffered heart attacks and strokes after taking its Vioxx painkiller. The drug more than doubled the risks of heart attacks and strokes among patients who used it to ease arthritis pain, according to clinical studies. One scientist estimated that it had caused as many as 138,000 heart attacks and 55,000 deaths in the United States. Merck sales teams for years played down the dangers of Vioxx, and a Food and Drug Administration official said he had been pressured to keep quiet about his concerns, according to congressional testimony. Still the FDA is open to letting the companies write their own reports so doctors can use them when they prescribe medications.

“If you build a drug and it works some of the time, that’s close enough, doctors should start prescribing it immediately and not stop until bodies start piling up and then you know what the downside risk really is,” said Efficiency Expert, a survival of the fittest kind of guy who encourages his children to play in the street believing that only the lucky and the strong should survive. “All this testing and retesting takes time and costs money. What’s wrong with a few lives destroyed or a handful of folks dead? We learn this way. It works for China. They’ve been taking this approach for years and have the world’s largest population. We’re all just living day to day with random chance anyway. We need to get over this ‘have to be more careful’ stuff and party on. I think stoplights at intersections are a waste of time too.”

In other news, the Orange County Register reported that an early morning burglar broke into an adult shop on April 15 and walked away with a $250 replica of porn star Jenna Jameson’s lower half. No word on whether the thief feels that marketing and science are basically the same.

(C) 2008 InebriatedPress.com

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