Saturday, September 23, 2006


Before I leave the hotel for my DC day, here's a quick news story. The US Food and Drug Administration could do a better job at reviewing drugs. No, that's not news.

Here's the news story: The Institute of Medicine, the people who stated that between 50-98 thousand people die each year from hospital errors, released a report Friday criticizing the FDA about how it reviews drugs, according to this report. Don't get me wrong, the FDA itself ask for the review.
Newly approved drugs in the U.S. should carry a warning that their safety isn't guaranteed, the medications should be reviewed in five years, and they shouldn't be advertised for two years, according to a report released Friday.

The report, released by the U.S. Institute of Medicine, said the Food and Drug Administration hasn't done enough to oversee new drug safety. The institute said the medications should carry a symbol, such as a black triangle, indicating they might not be safe. It also suggests agency rules be enforceable with fines.
Ok, let me get this straight. They want to put a warning that the safety isn't guaranteed? Why not put the same statement here that's on all herbal medicines: "This medication is not intended to diagnose, treat, cure, or prevent any disease." In fact, I believe that this puts more regulations than on herbal medicines.
"This report should be a watershed moment for FDA reform," said [Iowa Senator Charles] Grassley. "Public safety is at stake, along with the credibility of our nation's drug-safety agency."
FDA reform? Gimme a break. This is government bureaucracy. No one in this town that I'm sitting in right now has the courage and the political clout to do anything about it. The FDA is a good punching bag and the status quo will remain after all the hype. It's kind of like saying United Nations reform. Yeah right...


ClinkShrink said...

You're exactly right---this is ridiculous given that 20% of ayurvedic herbal medicines are contaminated with heavy metals and they are NOT regulated by the FDA or given mandatory blackbox warnings.

By the way, on the way back from DC you might enjoy a stop by the Tyson's Corner Apple Store depending upon your nerd quotient. You might need some iPod accessories for the trip back.

JR's Thumbprints said...

Is anything actually safe nowadays? All I know is that I'm having surgery Wednesday and I better not feel a thing. Plus, I better wake up when it's done.

And yes, Doctor Anonymous, you were correct in indentifying the cub scout now working in prison. Your reward: I'm going to link you to my blog. I know you're just thrilled. Yippee!

Parlancheq said...

Hmm...I've been saying this for years: Do not take a brand new med if you don't need to. In other words, if you're on a med that is working for you, do NOT ask your doc to switch you just because you see some flashy ad on TV! (The drug approval process is simply not set up to assess long-term safety or safety among diverse populations. Not ideal, but the benefit is that needed drugs get to market sooner.) On the other hand, my job depends on the pharma industry having lots of $$$ from people who are suckered into switching to new and expensive drugs, so maybe I should just keep my mouth shut. :)

~Mary said...

Hi Dr. A. New to your blog thanks to The Bestest Blog of all Time. I tend to be more natural than most simply because I believe the FDA is a crock and the pharmaceutical companies will do *anything* for profits. I do not believe there are "safe" drugs. Check out the warnings and side effects listed on the insert the drug store gives you. Neither do I take herbal remedies. My take is to try and stay healthy and avoid meds. I do not trust the FDA at all.

~Mary said...

BTW, I've linked to you.

Dr. A said...

Mary, thanks for the plug on your blog. I appreciate it.

ipanema said...

It's funny when they say, they'll label that this particular meds might not be safe. In the first place, they shouldn't be out in the market. It's like saying, take this and agree that I have nothing to do if anything goes wrong with you. This is crazy.

And the IOM is asking for more staff and budget to monitor post market drug safety. They should ask this from Big Pharma. FDA has no budget for this?

Jenny said...

Yeah right is so right. I get so frustrated with these things. Perhaps people should start taking a little more responsibility in what they put into their bodies as well. I personally look up EVERYTHING before I or my children or husband take it, be it given from the doctor's office or off the healthfood store shelf.
Even food.
I want to know where it comes from, what has happened to it on its way to me.
Granted, there are mistakes made in hospitals where patients are hurt and we need to be careful about that.
But, I get sick watching people just pop pills right and left without having a clue what it is, what it does and what sideffects it can cause. AND if it interacts with anything else they're taking. Did they bother to listen carefully to their doctor when he/she explained the medicine?
We're more careful about the kind of gas we put into our cars than we are about what substances we put into our bodies.
How is the FDA supposed to control this? Gads!
Gee, that felt kind of good, blow out the ol' arteries and get them cleaned out. Thanks Dr. A! LOL ;)