Anyone Who Still Believes That “FDA Approval” Means That A Drug Is Safe Or Effective Is Living In A Fantasy World!
By Nurse Mark
First, the most important fact about this drug: It was the tenth-best selling drug in the U.S. in 2008, with sales exceeding $2.4 billion. (1)
With money like that at stake, the rest of facts of this story should not come as any surprise.
The drug?
Actos – a diabetes drug manufactured by Takeda Pharmaceuticals.
The problem?
Bladder cancer. And more.
How big is the problem?
Huge.
Initial studies showed a 40% increase in the risk of developing bladder cancer in persons using Actos for more than a year. (2)
Another newer study shows that people who use this drug for more than two years have an 83% increased risk of developing bladder cancer. (3)
Let’s put that a little differently: if your doctor has you on Actos for two years or more (and conventional medicine considers diabetes to be a “lifetime” disease – as in “You’ll have to take these drugs for the rest of your life!”) you have a 17% chance of NOT getting bladder cancer.
I wouldn’t go to Las Vegas with those odds… much less gamble my life.
Who knew what – and when did they know it?
From the FDA’s own “Safety Announcement”:
In preclinical carcinogenicity studies of pioglitazone [Actos], bladder tumors were observed in male rats receiving doses of pioglitazone that produced blood drug levels equivalent to those resulting from a clinical dose. Additionally, results from two, three-year controlled clinical studies of Actos […] demonstrated a higher percentage of bladder cancer cases in patients receiving Actos versus comparators.
Preclinical means ‘way back before the drug was ever allowed to be given to humans. That’s right – in the earliest days of this drug, researchers (and presumably the FDA) knew that it was causing bladder cancer in rats.
Then, not one, but two clinical trials showed that the stuff was causing bladder cancer in people too.
And yet, the FDA approved the drug. For shame!
So, is that all? (as if bladder cancer isn’t bad enough…)
In March of 2007 Takeda was forced to admit that Actos was causing a greater incidence of fractures of the upper arms, hands and feet in female diabetics. (4)
And yet, the FDA allowed continued sales the drug. For shame!
Also in 2007, Takeda further warned that: (4)
- “… [Actos] can cause fluid retention when used alone or in combination with other antidiabetic agents, including insulin. Fluid retention may lead to or exacerbate heart failure.”
- “… patients with a history of previously existing cardiac disease were reported to develop congestive heart failure (CHF) when treated with pioglitazone [Actos]…”
- “Reports of hepatitis and of hepatic enzyme elevations to three or more times the upper limit of normal (ULN)
have been received in post marketing experience with pioglitazone. Very rarely, these reports have involved
hepatic failure with or without fatal outcome, …”
- “ACTOS may also be associated with hypoglycemia, edema, anemia, weight gain, and/or ovulation in
premenopausal, anovulatory women.”
- “In US placebo-controlled ACTOS monotherapy clinical trials, the most common adverse events (Ž5%) were
upper respiratory tract infection, headache, sinusitis, myalgia, tooth disorder, aggravated diabetes mellitus, and
pharyngitis.”
And yet, the FDA continued to allow sales the drug. For shame!
So, to sum up:
We have a drug that was known from the very earliest animal trials to cause bladder cancer, and then in human trials it caused broken bones, heart failure, hepatitis and even liver failure, anemia, infections, headaches, sinusitis, muscle pains, tooth problems and sore throats. Not only that, but it sometimes made diabetes, the very problem it was being given for, worse!
All this in a drug that doesn’t really work very well even when it does work – according to the FDA; “Across the approved doses Actos reduced HbA1c compared to placebo by an average of 1.5%.”
Wow – a whole, whopping 1.5%!
And yet the FDA still allows the drug to be sold. For shame!
Why would the sale of this dangerous drug still be allowed by the FDA – the federal agency charged with protecting Americans from harmful food and drugs?
For the answer to that I suggest you go back to the first, the most important fact about this drug: It was the tenth-best selling drug in the U.S. in 2008, with sales exceeding $2.4 billion. (1)
So, what’s the solution?
What can be done – safely – about type II diabetes, “pre-diabetes, ” “metabolic syndrome,” and the other names that conventional medicine gives to this disorder?
Plenty!
In fact, Dr. Myatt has a better than 90% success rate at correcting this problem within 90 days or less and she proves it with conventional hemoglobin A1c tests returned to normal, non-diabetic levels. No dangerous drugs, no strange or dangerous diets, just solid healthy success.
At The Wellness Club we don’t believe that type II diabetes is a “lifetime problem” – we fix it so you can get on with your life – no drugs, and no bladder cancer!
Learn more about diabetes here and find out about consultations with Dr. Myatt here.
References:
1. http://drugpatentwatch.com/ultimate/preview/tradename/index.php?query=ACTOS
2. http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm
3. http://www.bmj.com/content/344/bmj.e3645.pdf%2Bhtml
4. http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM153896.pdf
