A report by the Food and Drug Administration's (FDA) outside advisory panel released last Friday stated that the FDA is putting American lives at risk. Not only has there been a shrinking of the budget (after adjusting for inflation) of 15% over the past 15 years, the poor morale and political gamesmanship that goes on there makes it one of the government agencies with the highest turnover rates. That makes it hard for them to retain knowledgeable and experienced scientists. And that is putting us at risk from dangerous drugs. Just take Vioxx, for example. Tens of thousands of people died needlessly from heart attacks from taking this drug. And it doesn't work any better for pain relief than aspirin or Tylenol.
How did we get into such a mess? Well in the Reagan years it was decided that government, including regulatory agencies like the FDA, were inherently bad. I mean, does that make any sense? If they hired someone to run GE who then turned around and said the company was bad, he'd be out of there in a minute, right? Newt Gingrich, the chowder-headed former House Speaker from my own state of Georgia, actually tried to get the FDA shut down altogether. Naturally with all the budget cuts it took a while to get drugs approved and drug companies complained. So what was the brilliant solution? In 1992 they drafted the Prescription Drug User Fee Act (PDUFA), which allowed pharmaceutical companies to pay the salaries of the staff at the FDA through a fee (now $576,000) paid for each new drug application a drug company applied for. That was like letting the fox into the henhouse. They also said that funding for new drug evaluations coming from Congress had to increase by 3% per year. Since the overall funding for the FDA did not increase at 3% per year, the FDA had to actually cut funding for surveillance and research of already approved drugs. Hmmm. That means that they are now pushed to approve a drug as soon as possible, and once it is on the market it's basically a crapshoot since they don't have hardly anyone to keep track of it anymore. And to top that off there is now a push for legislation that says once the FDA approves the drug, a drug company can't be held liable for any problems that arise, because the FDA is the ultimate authority and they said it was OK in the first place. Hmmm again.
These days our health care and drug safety decisions are pretty much run by private industry. Case in point. Billy Tauzin did a back flip from Congress, where he ushered through the Medicare prescription drug bill, a boondoggle for drug companies because they said drug prices couldn't be negotiated, to President of the Pharmaceutical Research and Manufacturer's Association (PhaRMA), the lobbying organization for the drug companies, to the tune of two million dollars per year in salary. In response to calls for regulation of TV ads that often push drugs for people who don't need them, he said, "We don't make ice cream or handbags or automobiles, we make products that save lives." Whose lives? Here's another item. Daniel Troy, the Chief Counsel for the FDA under George W. Bush in 2004 was a political appointee who formerly worked in a Washington law firm defending the interests of pharmaceutical companies. While at the FDA he worked as a "friend of the court" on cases where pharmaceutical companies had been sued for drug safety problems. The logic was that the FDA approved the drug and therefore had an interest in the outcome. Hmmm, your tax dollars at work, I guess, not sure who they're working for though.
John Edwards recently said that you're not supposed to use the word "corruption" when talking about the government. "It's not politically correct," he said. Translation: don't call a pig a pig if you want to keep drinking at the pig trough.
I think it is time we turned the FDA back into what it was supposed to be: an agency that protects you and me from unnecessary risks from food and drugs, not a cheerleader for private industry.
Doug Bremner MD is author of Before You Take That Pill: Why the Drug Industry May Be Bad For Your Health: Risks and Side Effects You Won't Find on the Label of Commonly Prescribed Medications, Vitamins and Supplements.