The Safety Gap: Medicine

By Karen Abernathy - bio | email

It happens to two-million people every year. They take medication, hoping to get better, and instead they get worse.

Half of all Americans take at least one prescription drug. One in six take three medications or more. While all of these drugs go through an approval process, studies don't catch all of the problems. Adverse drug reactions cause 100,000 deaths a year. It's a struggle between money, medicine and safety.

Former pharmaceutical sales rep John Fratti took the drug Levaquin for an infection. He went from charging the basketball court to barely being able to walk.

"I was simply given a legal pill called Levaquin and now it's ruined my life. I've now been diagnosed with suffering from Levaquin-induced brain damage, damage to my nerves, damage to my tendons."

Less than a year ago, the FDA mandated the makers of the drug put a black box warning on the prescription for tendinitis and tendon rupture.

The statistics on adverse drug reactions are alarming. Americans are ten-times more likely to be hospitalized from an adverse drug reaction than from a car crash. Drug reactions are the fourth leading cause of death in the country.

Dr. Sidney Wolfe is the director of the Health Research Group for Public Citizens.

"The FDA and the industry are doing a terrible job of assuring the public that what they are getting after the doctor writes the prescription for them is adequately safe," Dr. Wolfe said.

Doctor Wolfe says user fees are a huge problem with the drug approval process. That's money drug companies pay the FDA to get their products reviewed and put on the market.

"We now find people at the FDA who refer to the drug industry as their customers."

Steve Grossman, President of the Alliance for a Stronger FDA, says some level of funding from the drug companies is necessary, because the agency can't survive on the current federal budget.

"The FDA needs about a $100 million increase just to break even with the program level that they've had the year before."

There's one safety issue that both the industry and activists agree needs attention -- drugs made overseas. In 2007, 43-percent of plants were in China, but inspectors visited less than three-percent of them.

"The number of manufacturing sites in China is in the thousands. It's still an uphill battle."

John Fratti is speaking out, to make people more aware that they need to be careful with medications.  He hopes it helps prevent a tragic mistake from hurting someone else.

"I want people to know that they need to be their own health advocate."

He said he doesn't want people to stop taking medicine.  He simply wants more questions to be asked, before they take that next pill.

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