You're in a pickle and in God we trust but not the FDA

Mr. President,
I hate to say it but you're in a pickle junior a real pickle. This gas price problem is a very big deal and as an ex-oil man you look guilty as hell. Your credibility is already non-existant.

You tend to use simple polarizing words to answer complex problems but I don't think you should try to explain how oil pricing works. You will only look silly trying to use your limited vocabulary. You can't use words like; good, evil, dead, alive, with us, against us, to describe this problem. Maybe your new press secretary can come up with some good weasel words.


I feel like a canary in a coal mine after I read about existing FDA practices and procedures.
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First of all you nominated another family friend, Dr. Andrew von Eschenbach to serve as commissioner of the Food and Drug Administration.
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When are you going to run out of college buddies and family friends to run critical departments?

The FDA turns out to be just another Bush-politicized agency like the CIA and the EPA. Ideology trumps science, and money trumps everything else. The way the FDA handled the "morning after " pill is one example.

In December 2003, an FDA advisory committee voted 23-4 to approve the pill called Plan B, called the "morning after" contraceptive pill. The FDA panel declared it was safe and effective for women 17 and older.
Your advocates against legalized abortion didn't want the pill available.
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The FDA panel was overruled by the head of the agency, and the pill was not approved. Senator Clinton and Democrat Patty Murray of Washington State have vowed to block any vote on Bush-family friend, von Eschenbach's nomination until the FDA decides whether to allow over the counter sales of Plan B, an emergency contraceptive pill.

So we go round and round until someone blinks, meanwhile, women are denied another avenue to avoid unwanted children because of right-wing ideology and anti-abortion factions have something to cheer about.

The FDA has been in the headlines several times during your administration for failing to protect the public. The Government

Accountability Office GAO recently issued a report on the FDA after the well-publicized VIOXX recall.
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Merck & Co. Inc. finally recalled arthritis pill Vioxx after it was linked to increased risk of heart attacks and strokes in long-term users.

They lost a third case this last Friday, when the court awarded $32 million in damages to the family of Leonel Garza, a 71-year-old retiree who died of a heart attack in 2001 after taking Vioxx.

So far Merck has lost three of the five multimillion-dollar lawsuits filed.
The crap really hit the fan after this recall. Several other FDA-approved drugs had also been recalled as well, so the Government Accountability Office began an investigation of the FDA.
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To get FDA approval of a new drug, companies 'generally' conduct clinical trials with hundreds or thousands of volunteers to determine if the product is safe and effective, but some safety risks may not be known until it has been taken by millions of people.

So the agency approves products with the condition that companies should provide more data, but it does not have the authority to call for those studies. As of last Sept. 30, there were 1,231 studies that companies had promised to do. About two-thirds of those promised tests had not been even been started.

Cases of "adverse events," for instance, are reported on a voluntary basis! Neither the drug companies nor the FDA calls for doctors to report drug-related problems they encounter. Experts estimate that only about 10 percent are reported.

Since 2000, ten drugs have been withdrawn by their manufacturers for safety reasons.

Frequently the drug manufacturers knew about adverse and even deadly effects of their drugs but kept it secret. They made the decision the benefits of the drugs outweighed the negative impacct of recalls or removal from the shelves.

THEY DECIDED NOT THE FDA! THEY DECIDED WHAT WAS IN THE BEST INTEREST OF THE AMERICAN PEOPLE? I am sure they never thought about the financial impact of disclosing harmful side effects of their drugs.

The U.S. really needs a separate office of drug safety. Like that's going to happen on your watch.

Nine of the panel's ten members on the National Institutes of Health-affiliated panel's acknowledge financial relationships with at least one statin manufacturer.

The GAO found the disorganization, bureaucratic infighting, unhealthy links to drug companies by FDA panel members, and an inability to force drug makers to conduct needed safety tests have kept the FDA from uncovering several dangerous drugs.

It was the British Committee on Safety of Medicines (CSM), the British equivalent of FDA that uncovered significant links of teenager suicides to anti-depressants. It was the CSM who shut down a U.S.plant in England when they uncovered the manufactured flu vaccine was contaminated. Our FDA had just inspected the plant and didn't find anything wrong.

The FDA is responsible for inspecting all plants that manufacture drugs and medicine for the US. Globalization has hit the legal drug trade like many other sectors, and the FDA does not seem to have enough resources. As of 2000, almost 80% of ingredients for US medicines are made overseas. I don't know how many of our drugs are made overseas this year.

Republican lawmakers argued that we couldn't import Canadian drugs because they were not under direct control by the FDA.
If they don't have enough people to check the foreign operations, what percentage of our drugs really are under direct control by the FDA?

I have a hell of a lot more faith in the British Committee on Safety of Medicines (CSM), than I do of your FDA junior. The CSM seems to consistently uncover dangerous drugs much earlier than the FDA.

I wasn't much for exercising and watching my weight; but until you leave the office and we get a competent president; well let's just say I found my motivation to stay healthy.

From: comments@whitehouse.gov
Date: April 27, 2006 12:52:07 PM CDT
To: guzmatom@mac.com

On behalf of President Bush, thank you for your correspondence.
We appreciate hearing your views and welcome your suggestions.
Due to the large volume of e-mail received, the White House is
unable to respond to every message, and therefore this response
is an autoreply.

Thank you again for taking the time to write.