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Drug Recalls Reveal More Problems

Content courtesy of Ivanhoe. For more information, click here.

Are yesterdays miracle cures becoming today's death sentences? When we go to the doctor or ER, we assume the drugs they prescribe have been carefully tested. A series of drug recalls reveal more drugs are causing problems. We trust today’s medical cures, but some have caused great harm. Who is to blame and who is at risk?

“My ears started to ring so loud, I couldn’t hear," Bob Grozier told Ivanhoe.

Grozier thought he was dying, and he could have -- after a bad reaction to Vioxx.

“I had no warning," he said. "There was no warning about any of this on the bag that I got."

The recall was the largest in U.S. history. Merck paid almost $5 billion dollars to 50,000 people who claimed cardiovascular injuries. It started a spiral of recalls of antidepressants, pain killers, arthritis medications, asthma treatments … how often are today’s medical breakthroughs tomorrow’s discredited science?

"In the last dozen years, far more drugs that were approved have had to be withdrawn from their market than in the entire history of drug regulation in the United States," Jerome Hoffman, M.D., Professor of Medicine at the University of California, Los Angeles, told Ivanhoe.

A recent study in JAMA says adverse drug reactions cause 100,000 deaths a year. Are drugs are being rushed to market? Are pharmaceutical companies promoting too much? Are patients demanding more than can be delivered? All of this is creating the perfect storm for disaster.

“Their safety is uncertain because they’re newer, and they eventually turn out to be very unsafe," Dr. Hoffman said.

Phil Brewer, Medical Director of Quinnipiac University in Hamden, Conn., is questioning the clot-busting stroke saver drug tPA.

“It will dissolve any clot, anywhere," Dr. Brewer said.

But that’s also its downside.

“You may have a clot somewhere else in the body that you need to be there and it dissolves that clot as well, and that area could begin bleeding," Dr. Brewer said.

Dr. Brewer was treating a man suffering a stroke, but the drug that was meant to save him, killed him.

"He ultimately died of his bleed," Dr. Brewer said. "TPA is a very dangerous drug. It’s a very powerful drug.”

But the American Heart Association says there's proof tPA works, and it's the only drug approved for urgent treatment of stroke. Others worry when it comes to taking drugs, patients only hear about the benefits.

"If people were to know, for example, that one third of all trials for antidepressants show that the products are no more effective than a placebo, they might be a little bit less reluctant to take those drugs," Peter Lurie, M.D., Deputy Director of the Health Research Group at Public Citizen, told Ivanhoe. "I’m not saying they shouldn’t take them."

In one year, $55 million were spent on advertising and promotion, almost twice as much as the industry spent on research and development.

“They’ve got to get on the market as fast as possible, and while it’s on the market, they have to put the hard sell as much as possible," Dr. Lurie said. "If it turns out it’s for some use the product doesn’t even work, well, that doesn’t make any difference: A dollar is a dollar."

“Overstating the benefits of the drugs, understating the risks, and the FDA is now letting them get away with it," Sidney Wolfe, M.D., Director of the Health Research Group at Public Citizen, told Ivanhoe.

The FDA has one of the strongest drug safety records in the world. But even it gets $400 million of its $2 billion budget from drug makers. Some recent decisions are coming under fire. In 1998, the FDA stopped 157 illegal prescription drug ads. Last year it was 23.

“If they are saying something false, then people are getting prescribed drugs that may be much more dangerous than the doctors that prescribed them thought they were," Dr. Wolfe said. Sidney wolfe, md

Experts believe it will continue until doctors and patients demand honesty, integrity and transparency from the drug companies. Right now, money rules the making and marketing of medicine.

For Grozier, it’s too late. He lost his job, his wife … his life as he knew it.

“I would have rather have died from my reaction," Grozier said. "I would have rather died.”

Many more people may face the same reality if things don’t change. The best way to protect yourself -- know the medicines you are taking. Research each one and know if certain medicines should not be taken at the same time. Also, check out www.recalls.gov for the latest drug recalls.

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