Source; Bill Sardi, Knowledge of Health, Inc., Copyright 2004

By Bill Sardi

“Unlike drugs, dietary supplements are not approved by the Food and Drug Administration (FDA) for safety and effectiveness.” This quotation from Office of Dietary Supplements, National Institutes of Health, has repeatedly been echoed by the news media. The false assumption is that drugs are far safer than dietary supplements because they have obtained approval from the FDA. This is despite the fact that the biological action of virtually every prescription drug can be duplicated with dietary supplements at less cost and greater safety.

Government health authorities, most of the nation's news press, and most conventionally-trained physicians quietly rebuff dietary supplements. Health authorities smugly believe they are more qualified to evaluate the safety and effectiveness of dietary supplements and so as not to argue with the public, they dismissively tolerate their use, of course in low doses that won't be harmful.

But recent shocking disclosures by Dr. David Graham, associate director in the FDA's Office of Drug Safety, that an estimated 88,000 to 139,000 Americans had heart attacks and strokes as a result of taking rofecoxib (Vioxx, Merck), have shaken the FDA drug safety program. The mortality numbers, he said, far exceed earlier disasters such as the 5,000 to 10,000 children born in the 1960s with birth defects related to thalidomide. Merck CEO Raymond Gilmartin claimed that the scientific findings that led to the withdrawal of VIOXX were "unexpected." Vioxx has been voluntarily recalled. But a Stanford professor alerted pharmacologists to the heart problems caused by Vioxx as early as 1996. How unexpected could this be?

Vioxx is a COX-2 inhibitor, a $2.5 billion in sales pain reliever for arthritis, touted for its ability to relieve pain without the gastric disturbances and ulcers often experienced with ibuprofen (Advil, Motrin).

How Drug Companies Gain FDA Approval

Another widely promoted COX-2 inhibitor pain reliever is Celebrex, made by Pharmacia. In 2000 the Journal of the American Medical Association (JAMA) published a study on Celebrex which showed that it had fewer side-effects than ibuprofen after six months of use. But what the JAMA reviewers didn't know was that the Celebrex study was 12 months long and the 1-year results showed that Celebrex was just as bad as ibuprofen. The reviewers had been deceived. FDA permitted the claim that Celebrex was safer based upon rigged data. Upset at the fact drug companies withhold negative studies from publication, eleven major medical journals now demand that all drug-company sponsored studies accepted for publication must be pre-registered in a database before the study begins so negative results can't be hidden.

Is FDA hiding another unsafe drug?

Is FDA hiding another “approved” drug that could cause mortal side effects in its closet? Reuters news service now reports that Avandia (rosiglitazone- Takeda Pharmaceuticals America, Inc. and Eli Lilly and Company), a drug used to treat type II diabetes, may cause a sudden and profound increase in triglycerides and drop in HDL “good” cholesterol. [Reuters Nov. 26, 2004] The blood fats of three patients on the drug returned to normal immediately following cessation of the drug. Reviewers are aware of two other cases. Researchers consider this a “rare” side effect because it wasn't reported among the 1400+ patients who previously used the drug. [Diabetes Care. 2004 Nov; 27(11):2577-80]

Researchers act as if they are surprised by this potentially serious side effect, when prior studies clearly point to the problem. In 2002 University of Texas researchers reported that Avandia raised triglycerides by 13%, but dismissed the problem because another companion anti-diabetic drug erased this problem. [Current Medical Research Opinion 18: 363-70, 2002] Last year, researchers in Helsinki reported that Avandia “unexpectedly caused significant increases in serum triglycerides” and warned that careful monitoring should be required. [Antiviral Therapy 8: 199-207, 2003]

Two years ago researchers noted that “none of the available trials” of Avandia or Actos (pioglitazone), another drug in the same class as Avandia, “include data on mortality or morbidity.” At the time, researchers concluded that “neither Avandia nor Actos has a place in the management of type 2 diabetes, except in the context of strictly controlled clinical trials.” [Prescrire Int. 2002 Dec; 11(62):170-6] How could researchers act surprised by all this? A third drug in the same class, Rezulin (troglitazone), was voluntarily withdrawn by its manufacturers on March 21, 2000. Researchers in Australia now report that Avandia and Actos produce “more frequent adverse events than previously reported in clinical trials.” [Med J Aust. 2004 Nov 15; 181(10):536-9] Did the drug companies hide negative data related to Avandia as they did with Celebrex?

FDA Incapable: Is This Only The Beginning?

Whistleblower David Graham, in his Congressional testimony, says the FDA is incapable of protecting the US against “another Vioxx,” and cited five more drugs as potential disasters in the making. These five drugs are the acne drug Accutane, the weight loss drug Meridia, the anti-cholesterol drug Crestor, the pain reliever Bextra, and the asthma drug Serevent. The FDA's deputy director of the Office of New Drugs, Sandra Kweder, dismissed Dr. Graham's charges, claiming he didn't stick with established FDA procedures when he disclosed these problems in a published interview in the British Medical Journal. Should Dr. Graham be shamed and sanctioned for breaking protocol while patients were dying of the side effects of these drugs? In an action that is an admission of malfeasance, the FDA just now invoked new rules on Accutane, one of the drugs on Dr. Graham's list, so that women who are prescribed this drug must first undergo repeated pregnancy testing and attend educational sessions before taking the drug. This action will limit or eliminate the Accutane-caused birth defects, but what of the terrible side reactions including suicidal thoughts that are linked with this dangerous drug (really a synthetic form of vitamin A)?

What Safety System Shall Be Used For Dietary Supplements?

Donald Marcus MD and Arthur Grollman MD, both university-based health authorities, want manufacturers of dietary supplements to prove that their products do not provide a substantial risk of injury to those who take them. They also want mandatory reporting of adverse events to the FDA.

“Drugs makers have to prove their product's safety and effectiveness,” says Ruth Sorelle, MPH, at Baylor College of Medicine. So, should dietary supplements fall under the same flawed and corrupt safety system as drugs?

There is no question that dietary supplement manufacturers all too often make false claims, and do not put the amount stated on the label in their pills, but where are all the dead bodies?

The corruption at the FDA Office of New Drugs is just beginning to be exposed. More horror stories will come to light.

Bill Sardi, Knowledge of Health, Inc., Copyright 2004