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If Low-T drugs are dangerous, why did the Federal Drug Administration (FDA) approve them?

A company that wants to market a drug in the U.S. must get FDA approval first, but it’s not the FDA’s responsibility to test drugs. The company that wants the approval to market the drug is supposed to conduct lab tests on animals and humans called clinical trials to determine the safety and effectiveness of the drug. The company then submits the information it has collected to the FDA for review by a panel of doctors and other experts.

Despite all this “rigorous” testing, FDA-approved drugs, one study suggested that FDA-approved drugs lead to over 100,000 deaths per year in the U.S. How is this possible? Well, the problem may be that the FDA requires the drug manufacturer to do the testing. First, clinical trials are incredibly expensive, so only Big Pharma, as the biggest pharmaceutical companies are called, can really afford them. Second, it’s in the companies’ interests to have favorable results because they stand to make a lot of money on the new drug. This sometimes leads to less-than-honest reporting or even blatant corruption, as was the case with Johnson & Johnson and its drug Risperdal. To top that, some of the doctors and scientists who work for the FDA evaluating the safety of drugs either used to work for pharmaceutical companies or go on to work for them, and this may lessen their objectiveness.

Marcia Angell, MD, former editor of The New England Journal of Medicine and author of The Truth About Drug Companies, stated:

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”

Ultimately, the FDA’s approval is only as good as the clinical trials that form the basis for it, and if those trials aren’t conducted ethically, or their results are skewed, the FDA may approve drugs that have potentially deadly side effects.

Richard N. Shapiro
Personal Injury & Wrongful Death Lawyer Serving Va Beach, Norfolk, Chesapeake & all of Virginia
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