Though it was taken off the market in September, it could be a while before the effects of the drug Vioxx have worn off.
Tom Methvin, managing shareholder of Beasley-Allen law firm in Montgomery, spoke at the Eufaula Rotary Club recently on the Food and Drug Administration and its role with Vioxx, a medication for arthritis and acute pain.
Methvin’s PowerPoint presentation showed the history of the FDA and its ties with drug companies, as well as how many people have been affected either through heart attack or stroke from taking Vioxx.
Methvin, a Eufaula native, explained that drug companies fund the FDA, which is the regulator of drugs.
“The FDA… is actually getting funds from who they’re regulating, which is a conflict,” Methvin said Wednesday.
Methvin said despite the drug company’s knowledge of the harmful side effects of Vioxx, the drug was put on the market anyway.
Merck, the drug company, spent more than Nike and Pepsi’s advertising budge to market the drug, he said.
In his presentation, Methvin had quotes from doctors and scientists who said the FDA receives outside pressure to approve drugs.
“An internal survey conducted by the FDA showed that 66 percent of the FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market,” the presentation said.
Another quote was from a doctor who was a 20-year FDA employee who said it was “extremely difficult to raise safety concerns within the FDA.”
“There is an extreme amount of political clout,” Methvin said. “The drug companies are running the FDA now.”
Methvin said several studies showed that Vioxx increases the risk of heart attack and stroke, yet Merck continued to cover up these effects.
“Instead of coming clean with the public and admitting it, they tried to cover it up,” Methvin said.
A commercial featuring the ice skater, Dorothy Hammill was used, and an internal memorandum said, “Dorothy is the only way to quiet patient concerns about CV risks.”
Methvin said the commercial and the memo “blows my mind.”
The FDA also sent two warning letters to Merck, basically telling the company it had “lied to the public,” Methvin said.
Methvin said it is very rare for the FDA to send a warning letter, and only one other letter has been sent since 1997.
Methvin said the drug companies’ moves have “put profit over people and… killed thousands of people in the name of making money.”
An internal study showed Vioxx increased heart attacks, strokes and death between 250 to 450 percent, Methvin’s presentation showed. The company knew this in 1998, he added.
In 2000, a study showed a four to five-fold increase in heart attack and stroke.
Then again, in 2004, the FDA sponsored a study looking at six million patients. It showed a 315 percent increase, Methvin reported.
A doctor “also concluded that at least 27,000 people died from heart attacks or stroke related to Vioxx,” the presentation said.
Methvin said these studies and the testimony of a “very high ranking doctor” have shown the public that the “FDA is broken, basically.”
“We can’t trust that another Vioxx isn’t going to happen,” Methvin said.
Methvin said there are currently Congressional hearings on the issue. The first civil trial in the country regarding Vioxx will be May 23 in Clay County, Alabama, with Beasley-Allen handling the case.
Methvin said he is optimistic that the FDA can get turned around, but it will be hard.
“It needs to be independent like before, 15 years ago,” he said. “I think it’s going to be hard to get the FDA really strong. There will be some changes, yes, but not all the changes that I think are necessary.”
Methvin said he would like to see the FDA not receiving funds from drug companies, no direct consumer advertising and any doctor that is going to work on FDA panels should not be a paid consultant. He also believes drugs need more extensive tests before approval.
“If so, people could trust the safety of what’s in their medicine cabinet,” Methvin said.
Meanwhile, President Bush has a bill before Congress that “would give immunity” to drug companies, Methvin said.
“It would end all Vioxx litigation,” Methvin said. “It would mean that Merck got away with it, basically. Hundreds of thousands of victims would go uncompensated.”
And if the bill passes, the future looks bleak for the FDA as well, he said.
“I would think you would not have an FDA reform if that got passed,” Methvin said.