Death by Diabetes Drugs Actos and Avandia: FDA’s Failure of Oversight

Actos is a drug that’s meant to treat diabetes. At least, that’s what  the advertising would have you believe—and it’s what doctors prescribing it will tell you.

However, as Gaia Health warned in Actos: Drug Promoted for Diabetes Prevention Causes Liver Damage, Actos is a killer—and both the manufacturer and the FDA have known all along.

Actos is a brand name for Takeda Pharmaceuticals’ pioglitazone. It’s also marketed as Glustin, Glizone, Pioz, and Zactos. A whistleblower named Helen Ge had been hired as a medical reviewer in Takeda’s pharmacovigilance section. However, she took her job serioiusly. Apparently, she believed it was her role to raise flags when risks were found. Most of her coworkers understood the real reason they were there: to provide cover so that the company could claim innocence of harms caused by their products. She tried to warn the company about discrepancies in adverse effects reporting related to their gout treatment drug, Uloric, and their diabetes drug, Actos. She was, of course, fired.

Among other things, Ge charges that Takeda’s in-house database showed 100 cases of bladder cancer from Actos, but they reported only 72 of them to the FDA. She found that early animal and Phase III studies showed it was carcinogenic. Ge also charged that Takeda changed trial enrollment criteria to hide its carcinogenicity.

And that’s not all that Ge charges was done to hide harmful effects of Actos. Takeda also failed to report cases of congestive heart failure that were known to be associated with Actos. Apparently, any excuse to minimize the seriousness of the condition was used. If the patient didn’t die, medical reviewers were instructed to report the event as not serious.

Actos Vs. Avandia

But the story gets even worse, though it’s a bit muddier. Ge says that a study comparing cardiovascular risks of Actos and GlaxoSmithKline’s Avandia (rosiglitazone) was rigged. Actos and Avandia are similar drugs from the same class. It isn’t surprising that both suffer from similar deficits. A meta trial comparing the risk of heart disease from the two drugs was done by Steven Nissen of the Cleveland Clinic. Both he and the Clinic are neck-deep in Big Pharma money. Gaia Health documents Nissen’s pharma ties in Major JAMA Study Shows Statins Do Not Prevent Heart Disease. GSK’s fraud hiding Avandia’s heart disease risks, along with the FDA’s collusion in covering it up, are documented in Fraud Found in GSK’s Avandia Trial Reveals FDA’s Lack of Oversight. There are no innocents in this tale.

Nonetheless, the fact is that Nissen’s ties are closer to Actos than to Avandia. According to Pharmalot in Takeda Hid Actos Links To Cancer: Whistleblower, he was a “principal investigator for a Phase III Actos trial and an imaging procedure he invented and was used in the trial may have generated about $13 million in revenue for his institution”. He had about 13 million reasons for bias in favor of Actos.

Both Actos and Avandia are killers. Both Actos and Avandia are guilty of crimes, up to and including murder for the deaths of uncounted numbers of people from those two drugs alone. Ss Helen Ge noted, it was “unconscionable” to single out one of them as bad, giving the false impression that the other is okay.

FDA’s Role

What has the FDA done to assure that Actos and Avandia can’t harm anyone? They’ve put warnings on them. That’s all, though both drugs are known to be killers. Both are used for type 2 diabetes, a condition that is best controlled by natural means: diet and exercise.

To even consider the use of a drug for control of type 2 diabetes should be considered questionable. The disease is nearly always caused by a combination of diet, lack of exercise, and pharmaceutical drugs like steroids. That doctors routinely prescribe drugs as toxic as Actos and Avandia is a travesty. They’re effectively telling their patients that popping a pill is an easy way out.

The FDA, which is supposed to be the public’s guardian against Big Pharma, has abdicated its role. Instead, the agency acts as their cheerleader. They have the information showing the dangers in Actos and Avandia. They know that Takeda and GSK stonewalled them by hiding adverse effects.

One would think that the FDA would elicit punishment, not only for knowingly hiding the fact that their drugs are killers, but also treating the agency like a bunch of saps! However, instead of coming down hard on both Takeda and GSK for hiding data and intentionally creating an image of safety that did not exist, the FDA has given them both a pass.

The FDA’s administration is neck-deep in the blood of people they’re tasked with protecting.

Tagged actos, actos heart disease, actos killer, actos versus avandia, avandia, avandia heart disease, avandia killer, big pharma, conventional medicine, diabetes prevention, fda, fda failure, fda failure of oversight, food and drug administration, modern medicine, pharmaceutical drugs, pharmaceuticals, pseudo-science, pseudoscience