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Thursday, March 09, 2006

The FDA

LOOK: I know this post isn't as sexy as Charlize Theron, but bear with me. It has a lot more meat than she does. ;o) In more ways than one...

The Food and Drug Administration is typical of a governmental organization: politically driven, slow, and staffed poorly. You get what you pay for? In this case, perhaps we're getting even less than that.

The FDA is too diverse, in an area where specialization is the only way to handle the increasing influx of work that they have. Their jurisdictions include food, drugs, medical devices, biologics, animal feed and drugs, cosmetics, radiation-emitting products, and anything that is a combination of the above.

They are responsible for inspecting fresh meat. However, they are only able to inspect 2% of all imported fresh seafood.* They are not even able to enforce restrictions on the cattle feed supply, which can cause bovine spongiform encephalopathy (BSE, or mad cow disease) in cattle which is easily passed on to humans (that's right; our beef is still not safe). Their attempt at preventative inspections for cattle with BSE is criminally negligent.* And Consumer Reports Agency researchers ruffled feathers in January 2004 when they reported in Environmental Health Perspectives that young chickens contain three to four times more arsenic than other poultry and meat.

But the FDA is also supposed to regulate the drugs on the market. They are expected to keep questionable drugs out of the country, and make sure that what is available is relatively safe for the consumer. But because they move at the pace of a severely constipated, crippled horse, the United States is way behind other countries in modern medicine.

For instance, when my son was born in 1993, the Chicken Pox Vaccine was already widely used and accepted in Europe, where it had a marvellous success rate for over 10 years. However, the FDA had continued to drag it's feet in approving it. The only thing that kept me from flying my baby out to another country to receive the vaccine was my doctor's reassurance that it would finally be available in the U.S. within a year (and it was).

Consider those 10 years that children suffered because the FDA couldn't move faster to approve that vaccine. And don't forget the rare deaths that were a result of Chicken Pox. Too bad the FDA can't be held responsible for withholding treatment.

Three days ago it was reported here that "Nearly two-thirds of more than 1,200 post-approval drug studies promised by the manufacturers have yet to start"; which should have caused a much greater outcry than it did. But this sort of story lacks the glamor of celebrity break-ups or serial killers and it's hard to communicate to a viewing public with the attention span of an average 2 year old.

What does this mean? It means that drugs which you are using may not have been proven to be safe or effective. However, complaining about it may be the wrong tactic to take (IMHO), when the FDA is so atrociously hesitant to even approve drugs which have been proven to be effective in other countries.

Additionally, the FDA is rather busy lately in it's attempt to shut down the import of safe, legal drugs from Canada. The reason is political, of course: Bush wants to force senior citizens to get on-board the new Medicare Part D bandwagon.

I don't have the time or ability to discuss Part D today, but it baffles many senior citizens (and we're not talking the senior citizens of yesteryear - these people are intelligent, active members of society).

The main reason that Bush is so gung-ho for it is that it's a way to privatize Medicare. Private companies are making great money this way, and I've been to conferences where it's touted as a sure-fire way for insurance agents to make big bucks, fast. Being as Bush is in the pocket of Big Business and special interest groups, this has his attention. And when cheaper drugs are available from Canada, and that impacts the pocketbook of Big Business, Bush's interest is increased. Sales of Canadian drugs to US citizens alone have skyrocketed over the billion dollar mark in the past few years. Who doesn't want a piece of that action?

So, the FDA is doing what it can to seize the shipments and muscle out the competition. While the vast majority of our food supply remains uninspected. While no one follows up on the drug studies. While we remain behind the rest of the world in advanced medicines. And Nero fiddles while Rome burns.

*Consumer Reports, Jan. 2005

18 comments:

Deb said...

Now that's a scary thought. And I thought getting holistic stuff was bad. They're not FDA approved. Screw it---basically nothing is! Eek!

I never heard of this before. I seriously thought they were the most well put together organization out there! I remember the FDA would do spot checks at this cheese company I worked at--and they were very efficient. It gave me hope.

Now...I'm confused! Wow...what an eye-opening post.

OldHorsetailSnake said...

Yeah, those rubes up in Canada frost me. Yahoos are saving me money. There oughta be a law.

Michael K. Althouse said...

Unfortunately, none of this comes as a surprise to me. Here's an interesting footnote though: There are exactly two drugs that are responsible for more deaths in the US than all others combined and they are not regulated by the FDA. Care to venture a guess? Alcohol and nicotine. The are controlled (sort of), but not by the FDA, but rather the ATF.

The ATF is NOT in the business of guarding against health risks. They are primarily a tax collection enforcement agency. They are only concerned with getting the money... lots of it. Even the innocuous drug caffeine is regulated by the FDA. What gives? The facts are painfully clear both with the FDA and the ATF - money is more important than people. How could they claim otherwise?

~Mike

United We Lay said...

They're focusing all their attention on the drug war, of course our food and drugs aren't safe. Look at drugs that have been approved in Canada to find out if they're safe and ALWAYS shop at Whole Foods or a comprable supermarket.

BarbaraFromCalifornia said...

Excellent post as always.

It reminds me of that commercial that shows a man selling insurance and being a photographer at the same time!!

Ellen said...

sad, sad, sad.... although I did get a chuckle out of your Nero remark.

As always... thanks for keeping us well informed.

Anne said...

Just more information to fuel my fire. People think I'm crazy when I talk about how bad our food is contaminated by the hormones, pesticides, antibiotics, food colors, preservatives, etc.

Money drives ALL things - to the detriment of the people.

Eddo said...

Very good information indeed - no tell me again why you aren't writing for Newspapers and Magazines? I know you used to, but man, this is good enough to be published and it needs to be.

Lee Ann said...

Very informative, and entertaining at the same time. Your analogy "move at the pace of a severely constipated, crippled horse", very good.
It is a shame that people don't have other's true best interest at heart.

Whistle Britches said...

I'm going to agree with Eddo here..

Jamie Dawn said...

It's scary that drugs are often out there for awhile, then they are recalled or have lawsuits against them for deaths, illness, etc... caused by the drug.
It makes me wary about taking any NEW drug.

Our food supply is a way for us to be attacked.

Dave said...

Saur,

Excellent post. You seem to have a good feel for the drug industry and the many challenges it faces.

Whistle Britches said...

ps
you had me at Charlize Theron..

Live, Love, Laugh said...

I agree with Jamie Dawn, there are two many things happening with new drugs nowadays.

It seems there is too much drug pushing goin on. When I went to my doctor, she gave me samples of new drugs to try. I didn't try any of them, I just took the one prescription for my respiratory infection and I hated to take it, I just couldn't get rid of the cough so I had to do something!

Saur♥Kraut said...

Live, Love, Laugh, that's because the reps give the doctors samples for free, in order to push a particular drug.

Uncle Joe, ;o)

Mr. Gator, :D I love you , you scaly old thing.

JD, yes, our food supply is most definately in danger. We're reliant upon the actual packers and processors, so lets hope their companies have lots of safeguards!

Acton Bell, I suspect it's always been that way, though I could be wrong.

Eddo & Uncle Joe, ;o) I now write for enjoyment, not deadlines. Someday I may do it again, though.

Lee Ann, ;o) Thank you. It is a shame, isn't it? I'm sure there are probably some individual inspectors with consciences, but they're either eaten up by the system or too busy to do anything about it.

Ann, Money DOES drive everything! You're right.

Ellen, you know, if you get tainted meat in your catering business, and use it, you will be the one accountable for it, not the FDA. Scary, huh?

Barbara, thank you.

UWL, I do a lot of whole foods, natural foods, etc., although I go to the regular grocery store, too. I try to stay more focused on veggies and fruits, because the more I read on how meat is processed and inspected, the more I distrust it. And I am SO not a conspiracy theorist.

Mike A, interesting about who regulates alcohol and tobacco. I didn't remember that, but once you said that I vaguely remembered a teacher telling us this in 8th grade. Strange!

Old Hoss, or there oughtn't be one... ;o)

Deb, yeah. The more I've found out over the years, the more disenchanted I've become with the system. It's extremely flawed.

Saur♥Kraut said...

Suzie, true. But they're not many in number. I never understood why anyone would chance taking that pill. Talk about risky!!!

boneman said...

The FDA...hmmmm.
Isn't that the same FDA that called marijuana the worse drug in the world? More dangerous than even tobbacco?
Sponsored by the same government that said something about for sure weapons, nuclear missles, and so on?
It is nice that there is a supposed entity to monitor the snake oil salesmen of today, but indeed, a travesty and completely worthless if biased to the reigning monarch.

ps....I used marijuana to help me quit drinking into binges of (I dunno what to call it exactly) blotto land. It worked and I can now a days have a couple glasses of wine a week without going into the bottle, so to speak.
Then, after some forty years of smoking (36 inhaling) I wanted to quit so bad but couldn't figure out how to get over the hump. I decided to try the pot method again, and somehow am still a non-smoker since Mar 16, 2002! HA!

mal said...

did anyone notice how fast Viagra went thru the approval process? Tells you where the priorities are