A stake through the heart (Part I)
There appears to be no bottom to it. I have attempted to inform you, my readers, about a problem that no one has an answer to and very few people seem to care about. It’s almost as if the phrase “what I don’t know can’t hurt me” has infected our entire national psyche. The what we don’t know is what is in our drugs.
Of all the drugs that patients waited to become generic, Lipitor stood out. It was necessary for so many patients, and it was expensive. Insurance companies would wrongly point patients to other less expensive, but not as powerful, drugs like it was OK. But, as it became clear to us that those that suffer from coronary disease need LDL levels less than 70, the power of Lipitor became more apparent. Lipitor was the largest selling drug in the world year after year, after year: $16 billion a year.
How is it possible that the company that brought the generic to market could be so careless as to have it tainted? Not only does it show just how broken the system is, but now the company has completely shut down production of atorvastatin. Does no one care? Are we doomed? Is this the new normal?
How does glass get into a drug? Why can’t we document and secure our drug sources?
Let’s take a look at the company. As reported in the New York Times on November 29, 2012, Ranbaxy Pharmaceuticals was in a heap of trouble before this incident. Ranbaxy is a subsidiary of a large Japanese pharmaceutical company called Daiichi Sankyo. As an interesting factoid, Daiichi Sankyo was the company that found the substance in Red Rice Yeast that became lovasatin. Second factoid: lovasatin is also found in oyster mushrooms. Yes, all my friends who only want to take “natural” drugs, that’s what lovastatin is – natural.
Anyway, I digress. Ranbaxy is operating under a consent decree issued on January 25, 2012. I quote from the decree:
“These problems include failure to keep written records showing that drugs had been manufactured properly; failure to investigate evidence indicating that drugs did not meet their specifications; failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination; failure to have adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date.”
What did the government do?
I quote: “Among other things, the consent decree prevents Ranbaxy from manufacturing drugs for the U.S. market at certain of its facilities until those facilities can do so according to U.S. standards. To remove false data contained in Ranbaxy’s past drug applications and to prevent Ranbaxy from submitting false data to FDA in the future, the consent decree requires Ranbaxy to take actions such as: hire an outside expert to conduct a thorough internal review at the affected facilities and to audit applications containing data from those facilities; withdraw any applications found to contain false data; set up a separate office of data reliability within Ranbaxy; and hire an outside auditor to audit the affected facilities in the future.”
So…they manufactured the active drug in India at a plant that was not shuttered in India and assembled the drug here in the United States. One would think that they would be extra careful, but apparently they don’t think like one. Ranbaxy had 43% of the market in October.
Folks, as Joe Biden would say, “If this is so screwed up, we are all in trouble. Can Gdufa save us?”
Read my next blog.