The FDA Kills

by Bill Sardi
by Bill Sardi

More than twenty years after four controlled studies showed that glucosamine and chondroitin supplements allay the symptoms of wear-and-tear (osteo) arthritis, the National Institutes of Health finally backs two studies to confirm what was known two decades ago. [November 2005 American College of Rheumatology meeting]

It’s not just that millions of arthritics endured pain while modern medicine drug its feet over acceptance of these dietary supplements, it’s that the delay actually cost many thousands of people their lives. Oh, arthritis is not life threatening, but the pain relieving drugs arthritics take are. Had modern medicine embraced these safe and natural remedies two decades ago, relatively unsafe drugs like Vioxx, Bextra, and Celebrex, as well as aspirin and ibuprofen, would have never been used so widely.

Dr David Graham, an official at the U.S. Food and Drug Administration, independently reported that the use of painkillers known as Cox-2 inhibitors since 1999 resulted in between 89,000 and 139,000 premature deaths from heart attacks or strokes. [Lancet 365(9458):475–81, 2005] Both the COX-2 inhibitor drugs (Vioxx, Celebrex, Bextra) and ibuprofen increase the risk for a mortal heart attack. [British Medical Journal 330:1366, 2005] The heart attacks and strokes emanate from an increased risk for blood clots caused by the COX-2 drugs. [Annals Rheumatic Diseases June 7, 2005]

“Whistleblower” Dr. Graham had to travel outside the country to disclose the mortal risks associated with these drugs. His superiors at the Food & Drug Administration were covering up the problem. What goes unreported is that since the 1980s the FDA was also abrogating its duty to educate the public that safer and more appropriate remedies for osteoarthritis are available – namely glucosamine and chondroitin.

The FDA did more than just approve problematic pain relievers, it promoted them over glucosamine and chondroitin. The May-June 2000 issue of FDA Consumer Magazine, reported on arthritis remedies and under the sub-headline “unproven remedies” said the following:

“Two controversial nutritional supplements, not approved by the FDA, have catapulted into the spotlight because of claims that they rebuild joint tissues damaged by osteoarthritis – or halt the disease entirely. But at this time, the use of glucosamine and chondroitin sulfate supplements warrant further in-depth studies on their safety and effectiveness, according to the Arthritis Foundation. … The Arthritis Foundation says there's no evidence that swallowed chondroitin is absorbed into the body and deposited into the joints. (Author’s note: this is untrue) The Arthritis Foundation urges anyone considering using these supplements to become fully educated about potential positive and negative effects. In addition, people are encouraged to consult their physicians about how the supplements fit within their existing treatment regimens. Above all, do not stop proven treatments and disease-management techniques in favor of the supplements.”

The newly published studies involved 1800 patients, the earlier studies nearly 1300 patients. [Pharmatherapeutica 3: 157–68, 1982, 2: 504–08, 1981; Current Medical Research Opinion 8: 145–49, 1982; 7: 110–14, 1980] How could the FDA say glucosamine and chondroitin were unproven?

Not only were there four more recent studies that confirmed glucosamine and chondroitin were safe and effective [Osteoarthritis Cartilage 6: A39–46, 1998; 6: A25–30, 1998; 12: 269–76, 2004; Journal American Medical Assn 283: 1469–75, 2000], the FDA knew that use of pain relieving drugs like aspirin, ibuprofen and acetaminophen result in thousands of avoidable hospitalizations, liver transplants and death. In 1997 there were 107,000 hospitalizations and 16,500 deaths from drugs like ibuprofen and aspirin. [Current Topics Medicinal Chemistry 5: 517–25, 2005] Add these morbidity and mortality figures to the problems caused by the COX-2 inhibitors like Vioxx to fully realize the misdirection by the FDA.