FDA official opens mouth, inserts foot

Can’t Buy a Clue

How completely clueless can an FDA official be?

So clueless it’s scary.

What makes it scary is when you can’t tell if the official is just spouting the party line, or if he actually believes what he’s saying.

And what really ups the fear factor is that this particular FDA official, Bob Moore, Ph.D., is a supervisor in the Division of Dietary Supplement Programs. So his views on supplements matter a little more to us than those of just any random FDA hack.

After Dr. Moore spoke recently at a webinar about supplement safety and adverse event reports, his comments were recapped in SupplySide–a natural products blog. Dr. Moore said that supplements are generally taken by healthy people, so the risks don’t outweigh the benefits.

Clueless? Yes. But that’s not the scary part.

Dr. Moore added that the side effects of pharmaceuticals are known and expected, and they offer sufficient benefits that outweigh the dangers.

I’m glad I don’t have to stand up and make that statement as part of a public record. Because the only way you could possibly live down the cluelessness of THAT position is to one day explain, “Hey, I was working for the FDA. What do you expect?”

Unknown and unexpected

Dr. Moore must have somehow missed the years of controversy in his own agency over a couple of the most dangerous drugs ever offered to unsuspecting patients.

Apparently he didn’t see a 2004 Washington Post article about FDA officials who tried to suppress an agency report that came to the conclusion that 27,000 heart attacks and sudden cardiac deaths could have been avoided if patients had been using Celebrex instead of Vioxx.

I’m pretty sure the families of those 27,000 patients wouldn’t describe the outcomes as “expected.”

And now there’s the Avandia controversy, threatening to blow up into another agency scandal.

The difference is that the increased risks of heart attack, heart failure, and stroke linked with Avandia are fairly well known. But do the benefits outweigh the dangers? I guess the answer is yes, as long as you’re one of the lucky ones whose heart doesn’t quit on you.

Bad as those two drugs are, however, I would offer statin drugs as an ideal poster child for unknown and unexpected side effects. Statins are the best selling class of drugs of all time. Millions of people have taken them for many years. And yet researchers have only recently understood that the common muscle pain side effect is actually a symptom of muscle damage.

And–oh yeah–new research also confirms that statins increase type 2 diabetes risk. Hey, but no worries–when you’re diagnosed with diabetes you can always take Avandia. I hear it can be effective if you survive it.

Are you getting all this, Dr. Moore?

I bet not. But before I let you off the hook, I have to go back to your comment about the benefits of supplements not outweighing the risks because supplements are generally taken by healthy people.

Where oh where did you come up with that cockamamie idea? Besides the fact that adverse events with supplements are overwhelmingly less risky than drugs, there are many thousands of patients who rely on supplements to treat serious health issues…

• Chondrotin and glucosamine for arthritis pain
• Probiotics for heartburn, irritable bowel syndrome and other digestive problems
• Vitamin B12 for anemia and diabetic neuropathy
• Calcium, magnesium, and Vitamins D and K for osteoporosis
• Niacin to balance LDL and HDL cholesterol
• Desiccated thyroid for hypothyroid
• Inositol for control of panic attacks
• Saw palmetto and pygeum for benign prostate enlargement
• Indigo naturalis for eczema
• St. John’s wort for mild-to-moderate depression
• Omega-3 fatty acids to improve vitality loss due to chemotherapy
• Milk thistle to alleviate liver inflammation due to chemotherapy
• N-acetylcysteine to reverse acetaminophen toxicity

And this partial list doesn’t even begin to address the proven preventive benefits of many supplements, such as folic acid (birth defects, heart disease), omega-3 fatty acids (heart disease, dementia), zinc and antioxidants (age-related macular degeneration).

I have to say it: On this one, Moore is definitely less.

To Your Good Health,

Jenny Thompson

Sources:
“FDA Speaker Says Supplement Benefits Don’t Outweigh the Risk” Holly Tully, SupplySide blog, 6/23/10, supplysideshow.com
“FDA Official Alleges Pressure to Suppress Vioxx Findings” Marc Kaufman, The Washington Post, 10/8/04, washingtonpost.com