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Posts Tagged ‘clinical trials’

Clinical trials bring us the new wonder drugs that would have been considered either magical or miraculous in earlier times. Are you interested in how drugs are tested to assure efficacy and safety?

On two episodes of Getting Better Health Care, clinical researcher Bea Abrams, PhD, with over 30 years experience in pharmaceutical development, explains the process of clinical trials done to bring a new drug to market.  She shares with us critical information that lets us know how much we can trust new drugs and what to look out for.

In a subsequent episode, I’ll be talking with Dr. Lawrence Friedhoff — author of the book, New Drugs: An Insider’s Guide to the FDA’s New Drug Approval Process for Scientists, Investors and Patients — about myths that surround new drug development.

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The news reported that cocaine may be adulterated with other dangerous drugs (http://www.bloomberg.com/apps/news?pid=20601124&sid=aN454DsoGaj4). Cocaine itself is a dangerous, potentially lethal, product. The take home message of this story is that unscrupulous manufacturers can adulterate any unregulated substance.

The FDA has documented many examples of so-called herbal and natural remedies that have been adulterated with real drugs (http://www.fda.gov/NewsEvents/Testimony/ucm184497.htm). Watch out. I have a lot of faith in the purity of regulated, prescription products. I have a lot of faith in over-the-counter products produced by large companies that have reputations to protect. I’d be circumspect about too-good-to-be-true claims of “natural” products that are supposed to work like miracles without drug side effects, especially when fly-by-night companies market those products.

Back in the 1990s, one of the most effective products ever seen for patients with skin disease was introduced and marketed as “natural”: a spray-on zinc product. Some thought it was a miracle cure for psoriasis. But then, lo and behold, researchers analyzed the product and found that it contained one of the most powerful steroids known to man.

We hear all about the side effects of real drugs. No drug is completely safe. Large clinical trials and careful follow up studies of drugs in widespread use are able to identify rare but serious side effects and increased risks of drug products. We know a lot about the benefits and risks of regulated drug products. It is folly to think that natural products are going to be able to magically produce the benefits of real drugs without any of the risks.

I’m not saying there isn’t a place for non-medicinal products. I am saying: Be Careful! Make sure you let your physician know all the products you are using, even if they aren’t prescription products. And take special care with products that come from companies you’ve never heard of. Such companies may have something to gain and little to lose by adulterating their products.

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