The Food and Drug Administration voted overwhelmingly to keep the diabetes drug Avandia on the market, despite its known deadly effects. Two FDA committees met yesterday in Gaithersburg, Maryland, to consider whether the drug — which has led to the deaths of 80,000 people — should be pulled from the marketplace.
The FDA does not deny that the drug is dangerous. Members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 20-3 to acknowledge the finding that the drug raises the risk of heart attacks, and called for stronger warning labels.
Dr. Clifford J. Rosen, from St. Joseph Hospital in Bangor, Maine, said after the meeting that “there was enough concern on the advisory committee that virtually everybody felt there was risk” of heart attacks from taking Avandia.
Nonetheless, committee members voted 22-1 to keep the drug on the market, knowing full well that the drug would kill some percentage of those patients who take it.
Avandia death toll: 80,000 people and counting?
The dangers of Avandia are well documented and are not news to the FDA. In May, the New England Journal of Medicine published a study that found Avandia increases the risk of heart attacks. But FDA officials already knew that; indeed the drug’s maker, GlaxoSmithKline LLC, based in London, told the agency of the risk two years ago. However, the FDA failed to pass along the warning to the one million Americans who already take the drug.
Even within the FDA, scientists have presented the risks of Avandia to colleagues and fellow committee members. Dr. David Graham, a drug safety officer with the FDA’s Office of Surveillance and Epidemiology, estimates that Avandia has caused as many as 205,000 heart attacks and strokes, some of them fatal, between 1999 and 2006. Graham’s analysis indicates that since Avandia was approved, some 80,000 patients have died from the drug’s side effects. For every month that Avandia is sold, he said, 1,600 to 2,200 patients will suffer more of these events.
The FDA’s continued approval of this drug, therefore, is a kind of death sentence for American consumers, racking up a body count so large that it already exceeds the total number of Americans killed in the entire Vietnam War!
Gerald Del Pan, director of the Office of Surveillance and Epidemiology, expressed concern about keeping Avandia on the market. “Cardiovascular disease being the leading cause of death of people with diabetes, having a treatment that causes that is something that doesn’t make sense to me,” he said.
Glaxo inundates the FDA with confusing data
Yet the majority at the FDA sided with the drug company Glaxo. “Let’s not throw out the baby with the bathwater,” Philip L. Hooper, a physician at the University of Colorado Health Sciences Center, stated, claiming that doctors need as many pharmaceutical resources as possible, apparently regardless of whether they are actually safe for patients.
Others within the FDA were quick to point out how difficult their jobs can be. Karen Mahoney, an FDA medical officer, said that reviewing all the relevant data was “extraordinarily complex.” The data sets were so complicated, she said, that FDA computers had to be upgraded to handle the load. Glaxo presented hundreds of documents including its own studies which claim that Avandia has no risk of increased heart attacks.
Graham noted that Glaxo’s internal research on Avandia lacked an untreated placebo group and suffered other design shortcomings. Similarly, FDA reviewers Chuck Cooper and Yu-Te Wu of the Office of Biostatistics called Glaxo’s research “questionable.”
Dr. Robert Meyer, director of the office within the FDA that approved Avandia’s initial application, based his argument in favor of Avandia on the fact that other diabetes drugs carry risks as well — so leaving Avandia on the market provides “treatment options.”
The drug’s maker took precisely the same stance: “It’s absolutely essential to maintain a full range of treatment options in this very important disease and Avandia has got to be a part of that range,” said Chris Viehbacher, president of U.S. pharmaceuticals at Glaxo, which earns more $3 billion annually from Avandia sales.
A new FDA standard of safety: Equivalent danger
In other words, Avandia was left on the market not because it has been proven safe (it has actually been proven dangerous), but because it is no more deadly than the other dangerous diabetes drugs on the market. This is a strange bit of FDA logic, where chemicals that are equally dangerous to the public are considered universally safe because no single chemical stands out as more dangerous than the others. In other words, drug safety no longer has any basis in absolutely safety to the patient and is, instead, based on each drug’s relative safety to other dangerous drugs.
By taking this stance, the FDA has made dangerous drugs the default. Consumers may now assume that all FDA-approved drugs are inherently dangerous and meet no reality-based safety standard whatsoever! Please also note that the FDA never applies such risk/reward calculations to herbs or dietary supplements. If an herb is implicated in the death of a single person, the FDA can rule it to be “unsafe at any dose” and outlaw it entirely. A pharmaceutical with 100,000 times that fatality rate, however, can be justified by the FDA as being “worth the risk.” Isn’t it interesting that this double standard just happens to coincide with the profit interests of drug companies who now control the FDA?
On news of the FDA’s vote, stock prices of GlaxoSmithKline LLC made the highest jump in two years. Business analysts noted the victory for Glaxo: “At 22-1, this was a clear endorsement of the product,” said Peter Cartwright at Evolution Securities in London. “They’ve strengthened the label. Now Glaxo can get back on the road.” And the FDA can get back to business killing people while pretending to be protecting them.
The truth, friends, is that nobody needs Avandia. Type-2 diabetes can be easily reversed in just three weeks (50% success rate) by simple changes in diet and lifestyle. My book, How to Halt Diabetes In 25 Days, details one very successful recipe for reversing type-2 diabetes. I personally overcame prediabetes and hypoglycemia using the same strategy outlined in this book, and thousands of readers have already cured their diabetes using this same information. (You can now see my health statistics, including fasting blood glucose numbers, at www.HealthRanger.org )
Why the FDA pushes diabetes drugs, not diabetes prevention
The FDA and drug companies don’t want consumers to find out the truth about how simple it is to cure diabetes because such information would substantially reduce the sales of highly profitable drugs like Avandia. Diabetes has become a revenue-generating disease that profit-minded corporations use to sell people a lifetime of dangerous drugs that neither prevent nor cure the disease — they just leave patients in a state of drug dependence, trapped in a system of medicine that requires them to keep paying for dangerous prescription medications sold to Americans at FDA-enforced monopoly prices. The whole system is a criminal operation and violates numerous federal laws on price fixing, anti-trade and racketeering. (In fact, RICO laws should be applied to Big Pharma right now, as the whole system is run much like organized crime.)
This latest decision by the FDA to keep Avandia on the market, knowing full well that it will kill tens of thousands of Americans each year, is yet another example of the FDA’s ongoing crimes against the American people (and its all-too-cozy relationship with drug companies). Once again, the FDA has sold us out, and the system of modern medicine has demonstrated itself to be an utter failure at preventing disease or protecting the lives of patients.
In my opinion, the 22 FDA panel members who voted to keep Avandia on the market should be arrested, prosecuted, and tried for their conspiracy involvement in this crime against the American people. I am not a proponent of the death sentence, so I would not support their execution (see the related CounterThink cartoon about executions in China), but force-feeding them high doses of Avandia sounds like a remarkably appropriate punishment for the harm they have unleashed upon this nation.
Today, following this FDA decision, America is less safe than it was yesterday, and the U.S. population is squarely in the crosshairs of the pharmaceutical industry which has created a hugely profitable criminal enterprise by sacrificing the health and lives of the American people. I find it curious that a movie like Apocalypto, which shows the widespread practice of human sacrifice in the Mayan culture, is looked upon with shock and horror by most American consumers while, in reality, America is sacrificing far more of its people upon the altar of corporate profits. The number of bloodied heads rolling down the steps of the pyramid of corporate profits in America today makes the Mayan practice of human sacrifice seem tiny in comparison.