Has offshore drug production and testing finally caught up with us? On Jan 23, 2015, the European Medicines Agency (EMA) recommended pulling four dozen generic drugs because they were approved based on flawed clinical studies conducted in India.
I’m familiar with many of the names on the 120-page list: Metformin, Arisept, Lexapro, Nexium, Valsartan/hydrochlorothiazide. These drugs are prescribed for diabetes, Alzheimer’s, depression, GERD, and hypertension – all lifestyle diseases not necessarily amenable to drug intervention. I also recognized many of the biggest companies in the pharmaceutical industry on the list.
A French inspection of GVK Biosciences in India revealed that “data manipulations of electrocardiograms during the conduct of some studies of generic medicines,” occurred for 5 years. They said that the systematic and prolonged nature of these manipulations and the number of staff involved “cast doubt” on the integrity of the trial methodology and the reliability of the data generated.
Drug regulators in France, Germany, Belgium, and Luxembourg immediately took action to stop the sales of 25 drugs. However, the FDA inspected GVK Biosciences in September 2014 after the French inspection in May 2014 but they said they found no evidence “that affects the safety or efficacy of drug products subject to pending applications or products approved in the US.”
About 40 drug applications received by the FDA from 2007 to March 2012 contained GVK clinical data, and some of these applications were approved. The FDA declined to name the drugs in question or say which were approved. Yet, they promised to take “swift and appropriate action” to protect American consumers.” We are still waiting for that swift action.
According to the Boston Globe Business Section, the cost of bringing a new drug to market is an astounding $2.5 billion and can take up to 10 years. So, what’s the point of doing it wrong? Actually, I don’t care to know because it seems like an incredible amount of money to spend on a drug, which, on average, will have 79 side effects and just suppress symptoms. As I noted in my last blog, we are on drug overload; there are 40 drugs to choose from for migraine pain and nothing to “cure” migraines.
While the whole allopathic medical world is distracted with the production of symptom-suppressing drugs, I urge you to look for real solutions. Listen to my Monday radio show at 4pm PST on Achieve Radio where you can learn about my Total Body ReSet formulas and Completement Now! Online Wellness Program. Your health is in your own hands.
Carolyn Dean MD ND
The Doctor of the Future™
SUMMIT: My talk on the Teen Parenting Summit is on Jan 28, 2015. Join now and learn easier ways to raise your teen daughter or granddaughter.
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