Don't Count on the Government to Save You From Dangerous Drugs

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.

Comments

[WrongWrongWrong]

"And it doesn't work any better for pain relief than aspirin or Tylenol."

This is a patently false statement, as a number of studies showed that Vioxx was significantly more effective than some other NSAIDs as well as acetaminophen. Likewise with the other COX-2 inhibitors.

[MJJ]

There is a "voluntary" reporting system that allows physicians AND patients to report problems or side effects. My suspicion is that few doctors use it. Statins, for example. The 40 or so ads one sees for Lipitor, Vytorin and the like all say, "A rare side effect of muscle pain and weakness." Rare, my foot! My mother-in-law wound up in a wheel chair because of these drugs. When I suggested that it might be the cause, her physician blew me off. I arbitrarily, against his instructions, stopped giving her the drug. Within 5 weeks, she was walking without assistance and the pain and weakness was nearly resolved. At least 5 people I know told me they or a loved one had the same experience. They advertise statins like candy. These are serious drugs with serious problems. I took it upon myself to file the report on the FDA web site. I wish the FDA would publicize this to consumers to balance the fact that they let the drug companies market directly to consumers. I'd like to see a notice at the end of each ad telling consumers to file reports of any adverse event. Maybe that would help!

[scooperss]

Yeah but, aren't they protecting us from buying our medicines cheaper in Canada?

(sarcasm)

[ScooterLiddy]

I feel the need for Lunesta. You are making me think too mush and it's past my bedtime...

[HeevenSteven]

Nurse Ratchet down the hall is gonna start putting drugs in your coffee if you don't be more careful about what you write.

I think you should to do MRI's of republican brains..er­..I mean heads.. to see what makes 'em tick.

[talking snakes]

Just say no.....to perscription drugs.
As everyone should know by now....big pharma supports medical schools across the nation, training doctors to think in terms of drug therapy and very little about nutrition and prevention.
The earlier you become sick, the longer you will stay on drugs and the better it is for pharma's bottom line.
Knowledge and early intervention is our only defense.
Cut and drug medicine (allopathic) is not the only way, but that's all you'll see on television.
Find out what's wrong with you long before you become ill. Here's something my naturopathic doctor did for me.
http://www.traceelements.com/

[hopeless277]

The government of the United States has one goal, kill as many people as possible in as little time as possible. It doesn't matter who the people are of where they live. They must be killed so that the killers can be paid large amounts of money to kill more. This country is the largest threat to freedom and democracy the planet has even known. Hopefully, someone will invade us and 'change regimes'.