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5/3/06

FDA Working for the Pharmaceutical Companies to ban Ephedra

You know, it really pisses me off when our government agencies that are supposed to protect consumers begin to represent the industry they are supposed to police.

The FCC does it. They favor big media conglomerates to monopolize the news by allowing them to buy out other news organizations. The rules were in place so that "free press" would actually mean something. Instead allowing these buyouts means there will be a much smaller number of people controlling the news you hear. But thats another topic for another day.

The SEC does it. They allow corporations and wallstreet to cheat investors, consumers, and taxpayers out of money, then change the law so that what the corporations did wasn't illegal after all. But thats another topic for another day.

Food and Drug Administration


The FDA is supposed to protect us from the Pharmaceutical Industry. According to their mission statement;

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
Prescription drug prices
Yet, the FDA has allowed prescription drug prices to soar in this country. So much for that affordable part. They have backed the pharmaceutical companies efforts to bar consumers from getting their prescription drugs from other countries where it can be purchased cheaper. So much for protecting the consumer from higher prices.

prescription drug tv advertising


They have allowed the pharmaceutical companies to advertise drugs on TV using misleading information to consumers. So much for the protecting the public health part. What happens is this. The rules the FDA uses to police those TV ads states the pharmaceutical company has 30 days AFTER the FDA notifies them to pull down the ad. That means the pharmaceutical companies can run any ad they want, say whatever they want, as long as they only plan to run the ad for 30 days. There is absolutely no penalty given to the pharmaceutical companies for placing the misleading ad in the first place. As I said, so much for protecting the public health.

ephedra is a natural herb


Now in regards to Ephedra. It is a natural supplement not produced by the labs of the major pharmaceutical companies that run the FDA. Under recent amendments to the Federal Food, Drug, and Cosmetic Act, the agency has to act product-by-product and the legal burden is now on the FDA to show that a marketed product is unsafe, rather than on the company to gain FDA approval by showing that the product is safe before it is marketed.

ephedra


That law applies to natural products such as ephedra or ma huang or herbal tea, st. johns wart, etc. The FDA must show that the drug is unsafe before banning it. The importers of these natural remedies do not have to prove they are safe. The burden of proof is on the FDA. Now in that mission statement above it says, "helping the public get the accurate, science-based information."

Yet, the FDA has not proven that ephedra is unsafe in the recommended dosages listed on the products that were sold over the counter. What has been proven is that ephedra was very effective at promoting weight loss and giving users more energy without any adverse side effects.

This means a lot of it was being sold, cutting into the profits of the pharmaceutical companies. The FDA can't allow those pharmaceutical comapnies to lose money to natural remedies.

steve belcher
The case they used was that of Steve Belcher, the baseball player


He was well known so his death made a great rallyiung point for banning ephedra. A medical examiner said probably Bechler's use of a supplement containing ephedrine, contributed to the cause of death. A bottle of that supplement was found in Bechler's locker.

But when they used his case to get rid of the evil ephedra that was cutting into the major pharmaceutical comapnies bottom line, they forgot to mention that these other factors contributed to Steve belcher's death.

* a history of borderline high blood pressure

* liver abnormalities detected two years ago but not diagnosed

* warm, humid weather during the workout

* he was on a diet and hadn't eaten much food the previous two days

* apparent use of Xenadrine RFA-1 an over-the-counter drug that contains ephedrine

* an apparent overdose of Xenadrine, using 150% of the recommended dosage

* reporting to spring training at 249 pounds, 10 pounds above his listed weight

* reporting to spring training out of shape, was pulled from conditioning drills

* did not participate regularly in team workouts, during the offseason


It was all these factors combined, apparently that contributed to Steve's death, not just the use of an over the counter, dietary supplement. Cytodyne Technologies, which makes Xenadrine, said in a statement "Physicians warn that many adverse events related to ephedra are due to people taking more than the recommended dosages.

Xenadrine has been the subject of numerous clinical trials on people, which have conclusively demonstrated that the product is safe and effective when used as directed."

Then it became political and the actual facts didn't matter much. Recntly a federal judge in Utah ruled that the FDA had not proven that ephedra at the recommended dosage was unsafe and ordered them to no longer confiscate shipments of the supplement.

The FDA is appealing, but did not ask the judge to stay the ruling until the appeal could be heard, which is the normal legal practice. Instead the FDA has chosen to simply ignore the judges ruling altogether and have continued to illegally confiscate the shipments. They have even done so in that same judge's jurisdiction.

It seems the FDA feels that any ruling against them by even a federal judge means nothing. Their loyalty to big pharmaceutical companies is all that matters. They have lost one lawsuit over ephedra and now are headed back to court being sued by yet another company.

When they lost the first lawsuit that said they couldn't confiscate ephedra shipments, they interpreted it as they couldn't stop that one company from shipping ephedra but were still free to do so to all other companies.

Their legal team has decided that each comapny must sue them individually. What a moronic idea. Ever hear of precedent? Ever hear of don't piss off a federal judge in HER own jurisdiction? Can't wait for the judge to hear this latest lawsuit.

More things that just piss me off
Who Let The Blog Out?

2 Comments:

Anonymous Anonymous said...

I applaud your blog,big pharma is a greedy racket.Daniel Haszard

6:38 PM  
Blogger NameCritic said...

Everyone who reads this should go to http://www.zyprexa-victims.com/ and read about Daniel Haszard's case.

Pharmaceutical companies are not in business to cure people. They are in business to make the most money off of your illness that they can.

Chris McElroy AKA NameCritic
http://www.thingsthatjustpissmeoff.com where you can start your own blog free. Speak Up!

10:25 PM  

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