Johnny come lately, what kept you?
Nothing like getting on the bandwagon after it’s already left the station. Especially when you’re the one who was supposed to be driving it. I’m talking about our good friends over at the Food and Drug Administration, tasked with protecting you and me from food and drug ills. Talk about falling asleep at the wheel. Well, now that they’ve wiped some egg off of their face with some recent-memory drug debacles, they are making a big show about the grand improvements they’re planning about how they’re going to do their job.
Admirable? Just ask the victims of those recent drug mishaps.
Part of the problem is that they’ve been puppets ensnared in the strings that connect them so tightly to Big Pharma. And what burns me up is that their grand new scheme includes making sure that drugs that are marketed are as safe as their advertisements say, and that they’ll institute an ongoing assessment that will measure the safety of drugs 18 months after they’re out on the market.
And they’re dragging their feet about getting this new order off the ground. As they drag their feet, you have to wonder how many people’s health and lives are at risk while they dilly-dally around. Patients are getting prescriptions handed to them every day in doctor’s offices across the country, many of them for new drugs fresh on the market whose long-term effects we have no idea about.
I want to know what right the FDA has to treat the matter of drug safety so nonchalantly that it’s only now coming to their attention that they are supposed to take an active role. It seems the FDA wasn’t present when their mandate was handed to them, which says that very thing: That they are to ensure the safety and efficacy of drugs that are sold in the United States. I suspect they were stuck deep in the pocket of Big Pharma and couldn’t make the meeting.
So many folks assume that because their doctor gives them a prescription for something, it is most likely safe and the most they have to worry about is taking it as directed, with just a miniscule chance of side effects. Little do they know that they could be the unwitting participants in real-time experimentation on products whose efficacy is sometimes questionable at best, and deadly at worst.
It makes it harder to bite the hand that feeds you when that hand supplies the agency with almost a quarter of its budget through fee assessments that the FDA gets from the drug companies, which makes up $400 million of its $1.9 billion budget. One of the puppet strings attached was a deal that said the FDA couldn’t use but a portion of that money to track the safety record of drugs on the market. Sounds to me like a deal with the devil.
This string that has tied the hands of the FDA is about to be cut this year as this deal expires. Drug companies—feeling the pressure over drug debacles such as Vioxx and Ketek—are agreeing that more money may be used to track the safety records of marketed drugs. But I’m just wondering if Big Pharma is going to let go of control so easily. Somehow, I’m thinking they will come up with a new hoop for the FDA. But that remains to be seen—what, in their infinite creativity to maximize profits, they will come up with next.
It’s illegal to try to pay off a police officer so he won’t give you a ticket, but the drug companies have basically gotten away with that very thing. A corrupt system that is bound to implode at some point, and the sooner it does, the better for the physical health of the whole country.
The FDA is also promising to get back to where they once were: With their own laboratories that performed independent studies on drug risks. I will be the first to get my fork out and eat if that pie in the sky promise comes true, but for right now, it seems too good to be true.
The best predictor of future behavior is past behavior, and when it comes to the FDA or Big Pharma, they need to lay down a mighty set of new tracks before I’m a believer.
I think you’ll agree with me when I say I’m from Missouri: Show me.
