At the time, the U.S. FDA responded by issuing a mere safety warning on the drug, leaving it open for continued sale and use in the United States.

Now a whistleblower has come forward with a lawsuit of her own, stating that the drug company making Actos, Takeda Pharmaceuticals, is benefiting in “tens of billions of dollars in sales” at the expense of the lives of people still taking the drug.

Actos Whistleblower Reveals Serious Fraud, Deception

Dr. Helen Ge worked for Takeda in the company’s pharmacovigilance division (this is, by the way, the same company that once received the “grand prize” for Consumers International “International Bad Products Award” – for advertising sleeping pills to children). There, Dr. Ge was in charge of reviewing side effects of Actos that were reported by patients and doctors. She then prepared safety reports that were filed with the FDA―reports that Ge says she was ordered to water-down or not report at all, so Actos would look safer than it actually was.

She believes Actos is even more dangerous than Avandia, a drug that has been removed from pharmacies because of the risk of heart attacks. Dr. Ge says that besides bladder cancer and tumors, Actos is also connected to heart attacks and stroke, suicide, schizophrenia, homicidal ideation, and renal failure. Dr. Ge filed her lawsuit in September 2011. But so far, Actos is still being sold in the U.S. She noted:ⁱ
“Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales.”

Takeda Purposely Mislead the FDA, Doctors and Patients, Lawsuit Alleges

The lawsuit alleges that Takeda, like many pharmaceutical companies, was interested in protecting their profits, first and foremost. Actos is Takeda’s most profitable drug, bringing in $3.4 billion in annual sales in 2009. From 2010-2011, Actos sales made up more than half of Takeda’s total revenue!ⁱⁱ There was clearly significant monetary incentive there, which was spelled out in the lawsuit:
“Upon information and belief, Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’ safety profile and to increase sales.”

The suit even includes a quote from the company’s vice president of the Pharmacovigilance Department, Dr. Maria Paris, who informed employees, including Dr. Ge:
“As a company, reporting adverse events is one thing, but we must make sure that the company has to be profitable first.”

Other allegations in the lawsuit include:

• Takeda caused thousands, if not millions, of false claims to be made on federal and state health care programs
• Takeda was able to capture a majority of the diabetes drug market by falsely portraying Actos as safer than it actually was·
• Actos is not as safe as Takeda has led the FDA, healthcare professionals and the general public to believe
• Takeda failed to properly report all of the Actos related congestive heart failure (CHF) events to the FDA, and even instructed its medical reviewers not to report hundreds of non-hospitalized or non-fatal CHF cases as “serious”
• Takeda improperly instructed its medical reviewers, including Dr. Ge, to change their professional opinion concerning adverse event classifications and assessments. When Dr. Ge complained of the improper reporting, her contract was terminated.
• Takeda’s failure to properly and accurately report hundreds of serious CHF events caused the FDA to falsely view Actos as safer than it really was, including in studies and reports that found Actos to be safer than Avandia

A Corporate Culture of Fraud, Driven by Economic Desire

The lawsuit further alleges that Takeda has a culture of fraud that is driven, primarily, by an economic desire to increase profits:
“Upon information and belief, Relator [Dr. Ge] alleges that the corporate culture at Takeda is riddled with systemic fraud and deceit with motivation to falsely report and under report not only serious Congestive Heart Failure events, but other serious side effects experienced by people taking Actos, driven by an economic desire to falsely enhance Actos’ safety profile and to increase sales.”

Other side effects that were under-reported include:

• Bladder, pancreatic and other cancers
• Suicidal Ideation
• Renal failure
• Cardiomyopathy
• Rhabdomyolysis (a breakdown of muscle fiber)

Much of the underreporting appeared to occur from late 2007 to January 2010, just as the news that Avandia was dangerous broke out. By limiting their reports of adverse events, they were able to (falsely) make it appear as though Actos was “a safe alternative” to Avandia, allowing them to gain a significant portion of the diabetes drug market at the expense of patients’ lives.

Drugs Don’t Cure Diabetes

In fact, drugs can’t cure diabetes, as they do nothing to address the underlying cause. Drugs like Actos and Avandia work by making diabetes patients more sensitive to their own insulin, helping to control blood sugar levels. In fact, most conventional treatments for type 2 diabetes utilize drugs that either raise insulin or lower blood sugar. Avandia, for example, lowers your blood sugar levels by increasing the sensitivity of liver, fat and muscle cells to insulin.

But you must understand that diabetes is NOT a blood sugar disease like your doctor may have led you to believe. Type 2 diabetes is actually a disease caused by insulin resistance and faulty leptin (a relatively recently discovered hormone produced by fat) signaling, both of which are regulated through your diet.

Conventional treatment, which is focused on fixing the symptom of elevated blood sugar rather than addressing the underlying disease, is doomed to fail in most cases.

Because type 2 diabetes arises from faulty leptin signaling and insulin resistance, it is therefore a fully preventable condition that can be controlled or reversed by recovering your insulin and leptin sensitivities. However, the only known way to reestablish proper leptin and insulin signaling is through a proper diet and exercise. There is NO drug that can accomplish this – a fact that makes the current disease paradigm even more tragic, as diabetes continues to skyrocket, and the conventional treatments are needlessly killing diabetics prematurely.

One in Four Americans Impacted by Diabetes … You Don’t Have to be One of Them

Amazingly, one in four Americans has some form of diabetes or pre-diabetes.

I too have personal experience with this disease. I developed it myself at one time after following the Eat Right for Your Type diet (I don’t advise anyone to follow the blood type A recommendations), and most of my paternal relatives (my dad included), have, or have died from, diabetes. My personal experience with this condition and subsequent review of the literature made it VERY clear to me that virtually every case of type 2 diabetes is reversible … And the cure for type 2 diabetes has NOTHING to do with giving insulin or taking drugs to control your blood sugar.

In fact, giving insulin to someone with type 2 diabetes is one of the worst things that can be done. Any physician still doing this suffers from profound ignorance of insulin physiology.

It’s important to understand that many of the conventional recommendations for treating diabetes are not only flawed but dead wrong, and I discussed the reasons why in this previous article. As mentioned earlier, to reverse the disease, you need to recover your body’s insulin and leptin sensitivities, and the ONLY way to accomplish this is through proper diet and exercise. There is NO drug that can correct leptin signaling and insulin resistance …

Adhering to the following guidelines can help you do at least three things that are essential for successfully treating, and reversing, diabetes: recover your insulin/leptin sensitivity, help normalize your weight, and normalize your blood pressure:

• Severely limit or eliminate sugar and grains in your diet, especially fructose, which is far more detrimental than any other type of sugar. Following my Nutrition Plan will help you do this without too much fuss.
• Exercise regularly. Exercise is an absolutely essential factor, and without it, you’re unlikely to get this devastating disease under control. It is one of the fastest and most powerful ways to lower your insulin and leptin resistance. I recommend reviewing my exercise program for tips and guidelines. It is also critical to work your way up to include some Peak Fitness exercises.
• Avoid trans fats.
• Get plenty of omega-3 fats from a high quality, animal-based source, such as krill oil.
• Optimize your vitamin D levels. Recent studies have revealed that getting enough vitamin D can have a powerful effect on normalizing your blood pressure.
• Optimize your gut flora. Your gut is a living ecosystem, full of both good bacteria and bad. Multiple studies have shown that obese people have different intestinal bacteria than lean people. The more good bacteria you have, the stronger your immune system will be and the better your body will function overall. Fortunately, optimizing your gut flora is relatively easy. You can reseed your body with good bacteria by eating fermented foods (like natto, kefir, raw organic cheese, miso, and fermented vegetables) or by taking a high-quality probiotic supplement.
• Address any underlying emotional issues and/or stress. Non-invasive tools like the Emotional Freedom Technique (EFT) can be extremely helpful and effective.
• Get enough high-quality sleep every night.
• Monitor your fasting insulin level. This is every bit as important as your fasting blood sugar. You’ll want your fasting insulin level to be between 2 and 4. The higher your level, the worse your insulin sensitivity is.

References:

ⁱSalient News March 12, 2012

• ⁱⁱ Salient News March 12, 2012