Vioxx: The Worst Drug In History?

| February 4, 2013
Vioxx

Dr. David Graham stated in testimony before the US Senate that Vioxx was the “single greatest drug safety catastrophe in the history of this country or the history of the world.”

 

Back in 2004, the pharmaceutical giant Merck suddenly pulled its arthritis painkiller Vioxx from the US market. It was an unexpected move, considering that this blockbuster drug had been marketed in more than 80 countries with worldwide sales totaling $2.5 billion in 2003.

Something was fishy… very fishy indeed.

Vioxx was only on the market for four years. So as far as blockbuster drugs go, it had a very short ‘shelf-life’ and it made no sense for Merck to voluntarily withdrew one of its biggest money spinners overnight.

Merck’s decision came shortly after a study found a higher rate of heart attacks and strokes in patients taking Vioxx than in those taking a placebo. But this new Vioxx study was not the first to raise concerns about heart attack and stroke risk. Steven Galson, acting director of the American Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, said the day Merck announced the withdrawal that “We have been concerned and aware of the potential for cardiovascular effects for the last few years. This is not a total surprise.”

The FDA might not have been surprised, but for Joe Public who was led to believe that this drug was safe, the Vioxx scandal had terrible consequences.

Shortly before the approval of Vioxx in 1999, Merck implemented aggressive marketing and public relations strategies to boost sales of the drug. These marketing strategies came in direct conflict with the science but in the interest of profits, science and patient safety took a back seat.

Marketing teams at Merck played a direct role in the clinical trials. For instance, they doctored the results from one particular clinical trial that compared Vioxx and naproxen. The real results showed that Vioxx increased cardiovascular risk. However, Merck officials spun data and stated instead that naproxen decreased cardiovascular risk… Merck also employed ghostwriters to write twenty fake scientific articles, showing positive results, and published them under the names of respected scientists.

To make matters worse, researchers already raised concerns about the possible cardiovascular risks of the drug, as early as 1996, but Merck only officially concluded that patients on Vioxx were more than twice as likely to suffer heart attacks or strokes until September 23, 2004 – seven days before it withdrew the drug.

In the aftermath of this debacle, Dr. David Graham, the Associate Director for Science and Medicine in FDA’s Office of Drug Safety at the time, calculated that the Vioxx had resulted in 55,000 premature deaths from heart attacks and strokes and caused 100,000 unnecessary heart attacks in the U.S. alone.

That’s 55,000 deaths too many. Deaths that could have been avoided.

But Merck was not the only party with blood on their hands.

The FDA had every oppertunity to withdraw this killer drug long before 2004. In fact, many FDA scientists who raised concerns about Vioxx and other similar drugs faced intimidation and threats from supervisors and were asked to change their research. Senior FDA officials called Dr. Graham’s research “junk science”. Officials retaliated against researchers for speaking publicly about their research or attempted to censor scientists from publishing research in scientific journals.

This culture of abuse and lack of integrity later led Dr. Graham to state that the FDA was “incapable from protecting us from another Vioxx” and Eric Topol, chief of cardiovascular medicine at the Cleveland Clinic, said: “The FDA didn’t do anything. They were passive here.”

It is terrible to think that the lives of patients are put in the hands of corrupt pharmaceutical giants and mainstream officials like these… No wonder patients are concerned that medical authorities are not competent and aggressive enough in how they monitor drug safety. And who can blame them? With Big Pharma doctoring trial data and clinical results to suit their marketing strategies, and medical authorities buying into a culture of turning every new drug into a cash cow, patient safety is clearly of very little concern.


Take action right here and now!

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Stop Big Pharma… and help save thousands of lives.


Sources:

How did Vioxx debacle happen? published online 10/12/2004, usatoday30.usatoday.com

Vioxx shows what happens when the drug safety system breaks down, published online 03.19.2012

Testimony of David J. Graham, MD, MPH, November 18, 2004

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Category: Killer Drugs Banned

Comments (3)

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  1. Dan says:

    It makes me sick reading this… How did we get to this point, where human lives are worth so very little?

  2. Talia says:

    Signed and shared!

  3. Adam says:

    Vioxx is a true horror story. It’s a scandal that this drug was ever allowed to cause so much havoc. Petition signed!