Q: What’s the Food and Drug Administration doing about assuring the safety of generic drugs?— Randy P., Flemington, N.J.
A: We’re very familiar with the FDA; Dr. Mike has served on FDA advisory committees for 16 years, chaired an FDA advisory committee and even has shepherded specific drugs through trials. The agency is understaffed, underfunded and overworked. That’s why even though generic drugs make up about 80 percent of all prescriptions in North America, according to the FDA itself, the agency doesn’t have the resources to perform independent clinical studies of generics and lacks the authority to require the industry to conduct such studies. But that’s all about to change.
Recently the FDA was forced to halt the sale of generic drugs from two facilities in India (Ranbaxy Labs and Wockhardt Ltd.), citing issues of drug safety. That put a scare into the FDA, consumers, doctors and the more worthy manufacturers of generics. They know if generics get a reputation as unreliable or dangerous, no one will want to take any generic. So the manufacturers have bumped up the FDA’s paltry $2 million budget for dealing with generics to $20 million and are sponsoring a testing program. According to Bloomberg News, this will be the first time the FDA has begun a widespread effort to check and evaluate the quality of generics. Starting with generic heart drugs, ADHD treatments, immune suppressants, anti-seizure medicines and antidepressants, Duke University, Johns Hopkins, Brigham & Women’s Hospital and the universities of Florida, Michigan and Maryland will conduct the research into the quality and efficacy of the medications.
Until then, always discuss the pros and cons of brand versus generic drug prescriptions with your doctor and pharmacist before taking any medication.
Q: I just read that saturated fats aren’t really bad for your heart. So cheeseburgers are OK now?— Gary T., Mobile, Ala.
A: Hold on, Gary; take a step back from the drive-thru. The reporting on a couple of new studies about the health effects of eating saturated fats is missing a nutritional boatload of information.
In study No. 1, published in Open Heart/BMJ, researchers concluded that if you replace saturated fat in your diet with known heart-damaging foods such as refined carbohydrates and excess amounts of omega-6 fatty acids, you are not doing your heart any favors. Well, duh!
The real point? You can’t boot trans and most saturated fats out of your diet and then ignore our advice on eating only 100 percent whole grains or avoiding added sugars and sugar syrups and expect to stay heart healthy!
And in study No. 2 from the Annals of Internal Medicine, well, we have no way of knowing about the general dietary or lifestyle habits of the thousands of people in the 76 studies that got lumped together to somehow determine the non-benefits of omega-3 supplements.
So our advice remains the same: Boot trans fats from your diet; don’t eat red meat (its relationship to heart disease and cancer are valid); skip any skin from two-legged creatures; eat 100 percent whole grains; and eat 9 servings of fruits and veggies daily. And get the anti-inflammatory benefits of omega-3 fatty acids from salmon, walnuts and a 900-mg DHA supplement daily. You’ll have a younger RealAge and a healthier heart!
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