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Wednesday, 14 January 2009

What Changes Does Obama Need to Make in the FDA?

Obama promised to focus on food safety, but the real problems are much more insidious and dangerous than salmonella ever was.

Recent articles and editorials have popped up all over the place about the changes Obama might make in the FDA. Obama said he plans to focus on food safety. In light of the recent salmonella outbreaks, that obviously needs attention. But the real damage to Americans isn't caused by this type of unusual situation; it's the day-to-day practices of the FDA and Big Pharma that are killing Americans and ruining their lives.

What are these destructive day-to-day practices? To name just a few:

Direct to consumer advertising

There's a reason why this is outlawed in other countries. People see ads on TV about a drug. The ads depict people who are obviously not happy, for example, and suggest we ask our doctor about the drug they're advertising. Which we do, in droves. The doctor, whose info on the drug comes primarily from the drug company whose chief interest is money, prescribes it. The diagnosis was done by the patient, as guided by drug company.

Off-label marketing and prescribing

The FDA approves a drug based on testing done under specific conditions on a specific ailment. And the drug company is not allowed to market the drug for anything else. But they do. They don't do big TV ad campaigns about using the drug for other than the approved ailment - that's too easy to get busted for because it's so visible - but they do promote directly to medical professionals who then prescribe them to their patients. Is it safe to use a drug for something other than which it was tested and approved? Absolutely not.

Big Pharma withholding information from the FDA

When a drug is submitted to the FDA for approval, the drug manufacturer's test results are included. But not all of them. The studies that got favorable results are submitted, those that show the drug to be dangerous or ineffective are not. Consequently, FDA approval is based on skewed data.

Many of the drugs don't really work, and they are dangerous

As an example, two out of three people who take antidepressants are still depressed - according to a recent TV ad. The ad suggests that, if you are one of those people, you should take another drug (called Abilify) on top of your regular antidepressant.

The side effects of antidepressants include dry mouth, urinary retention, blurred vision, constipation, diarrhea, nausea, abdominal pain, sedation, sleep disruption, weight gain, headache, inability to achieve an erection, inability to achieve an orgasm (men and women), loss of libido, agitation, and anxiety. Some are also lethal when combined with other drugs. And they cause suicidal thoughts and make a person want to hurt themselves.

If taking these drugs does not relieve our depression, we're supposed to keep taking them - how ridiculous does that sound? - and add another one - Abilify.

The side effects of Abilify include most of the above, and:

 Very high fever, rigid muscles, shaking; confusion, sweating, or increased heart rate and blood pressure - which, according to the drug's manufacturer, could be fatal;

 abnormal or uncontrollable movements which, again, according to the manufacturer, could be permanent;

 diabetes or an increase in blood sugar levels which, in some cases, have resulted in coma or death;

 impaired judgment, thinking, or motor skills;

 an inability to lower the body's temperature, so you have to make sure you don't overheat or get dehydrated.

How many people are sick because of the drugs they're taking? And they don't even work.

The Systematic Stripping of FDA Funding, Personnel and Power

Are all of these problems the fault of the FDA? Not by a long shot. Big Pharma has successfully lobbied for decades to strip the FDA of its funding, personnel and power. The FDA now serves Big Pharma.

With this mission accomplished, Big Pharma is now pushing to make it illegal for a State to try a case against a drug company. Settling lawsuits costs drug companies millions every year as more and more people suffer from everything from prescription drug addiction to liver disease to death. How do they think they can get away with this? They argue that Federal authority preempts that of the State, and the drug was approved by the FDA, a Federal entity. A cunning and insidious plan that absolves Big Pharma of all wrong-doing and leaves the public they've victimized to deal with the problems on their own.

These are the problems Obama should resolve. Let's hope he's well-informed and can take the Big Pharma giant down before we have an entire nation of drugged zombies and no one to be held accountable.

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