Can We Trust the FDA?

That was one of the headlines I saw on my crisp new Reader's Digest that came in the mail. Immediately, it grabbed my attention. I already had my ideas and opinions about the FDA but was curious what Reader's Digest had uncovered. I flipped to the article and dug in. I'll share with you some of the more alarming information. Before I get started sharing, let me just say: If you believe your medicine is 100% ok because it was approved by the FDA, you need to read this article. If you are slightly questionable about the FDA, you need to read this article. Or if you're like me, and concerned about what is defined as "good" for you by the FDA, you need to read this article. It is eye-opening for those who feel completely safe with how the medicine in our country is being developed and dished out.

I'm going to share information in this article that really stands out. I am also going to take it upon myself to highlight those points I really think you should take note of.

Let's get started. The initial paragraph starts out with some disturbing information:

"Recent headlines have uncovered one shocking lapse after another at the Food and Drug Administration: A popular diabetes drug can sharply increase the risk of heart attack, a finding the agency knew but took two years to reveal. An FDA-approved antibiotic can destroy your liver in just five days (BABIES TOOK TH IS ANTIBIOTIC, PEOPLE!!!). And despite mounting concerns about the safety of Chinese-made drugs, the agency had only enough field inspectors last year to check a mere 13 of the 714 Chinese factories that produce medicines for U.S. consumers."

Scared yet?

"'Think your pacemaker, heart valve, microwave oven or morning vitamin was inspected?' asks former associate commissioner William Hubbard. 'Dream on.'"

In the article, FDA's own advisory Science Board describes the agency as "nearly out of control". They said they were "shocked and appalled" with the state of science in the organization. Garret Fitzgerald, an MD and a chairman of pharmacology at the University of Pennsylvania School of Medicine compares the FDA to Hurricane Katrina. He says, "But we have to fix this before the hurricane hits." That's HUGE. Hurricane Katrina devastated so many families. Here, this man is saying that the FDA is about to (I say they already have) do the same thing if things don't change!

"Drug safety is perhaps the greatest concern. The respected Institute of Medicine, created in 1970 by the National Academy of Sciences, recently labeled the FDA's drug branch 'dysfunctional,' saying it muzzles scientific dissent, inadequately monitors drug safety and relies too heavily on drug company dollars."

The article describes one of the most recent troubles for the FDA. It was in 2004 when officials in the organization were at the receiving end of harsh criticism for "silencing" a scientist on their staff who "concluded that antidepressants could increase suicidal behavior in teens." In that very same year, the organization was "criticized for not acting quickly to take the painkiller Vioxx off the market after it was shown to increase the risk of heart attack and stroke."

Ok let's take a breather here. Think about what you've read already. AND you're trusting the medication that the FDA approves and you're putting it in your baby's body?! Please be cautious in dispensing medication to little ones. They don't have the power to choose!

The article describes some of the major problems within the FDA. The first mentioned is that they receive so much pressure from the industry. They have pressure to "speed decisions, and there's pressure to soft-pedal problems." So what they're telling us is that mediations are going on the market without adequate testing and with little to no follow-up testing. "Critics of the FDA like to say it's the best agency the pharmaceutical industry can buy."

They say that quicker approval of drugs can be beneficial if you need a life-saving drug on the market, but it often creates problems because, "The easiest way to make those deadlines is not to raise too many questions and just accept what the drug companies say about safety." This quote was made by a former FDA drug reviewer David Ross, MD. He goes on to say, "Too often, reviewers tel their FDA supervisors that a drug doesn't work or has a major safety problem and 'managers come up with contrived reasons to approve the drug anyway."

According to this article, there has been "an alarming spike in adverse drug reactions reported to the FDA recently, from 267,000 in 2000 to over 471,000 in 2006. And the number of reported deaths has nearly tripled, from 5,519 to 15,107.....That's only part of the story. The agency estimates that it learns of fewer than one in ten drug reactions." That WORRIES me! We are only hearing what is being reported. FEWER than one in ten is reported!!! According to Gwen Olsen's essay, that is because the drug companies make it so time-consuming for the MDs to report drug reactions. That make it seem "not worth the effort".

This article is so long, and I want to share everything in it, but I can't. I am going to share some more stand out quotes:

"Some risks of a new drug may not be revealed for years, until thousands or even millions have used it."

They list other problems within the FDA: sloppy record keeping, conflicts of interest, and muzzled experts.

"Many (FDA) staffers say they've felt pressure to soft pedal product dangers or suffer consequences."

Within the article, they share information and stories about an antibiotic that killed many people, including babies, by destroying their liver...in 3-5 days!!!

GET THIS MONTH'S READER'S DIGEST! April 2008. Read the WHOLE article. You won't be wasting your time, I promise. You need to see this information.