Econintersect: Katherine Eban, along with reporter associates Doris Burke and Frederik Joelving, have published an excellent investigative journalism story in Fortune. The subtitle for the article tells only part of the story:
“The epic inside story of long-term criminal fraud at Ranbaxy, the Indian drug company that makes generic Lipitor for millions of Americans.”
This is not just a story about Lipitor, and not just about Ranbaxy, but also about an entire system of drug approval, oversight and regulation which is seriously flawed, even criminogenic.
The story of Ranbaxy may have started in India but it quickly ensnares the FDA (Food and Drug Administration) in the U.S. This agency has responsibility the approval of new drugs (and generics) and changes in the production of existing drugs. The agency is is presumed to be responsible for determining that all representations by drug producers are correct.
In fact, the FDA operates with drug producers using the honor system: Whatever the drug company represents to be valid data is accepted and evaluated. The Ranbaxy story is about a company that apparently fabricated all the data it presented to the FDA. And the fabrication was rife with indications that it was phony, with cases ranging from too good to be true to obvious plagiarism of data for a generic from the original work on the patented drug.
The Fortune story details how time and again over the past decade the FDA has failed to act expeditiously, or even to act at all, in some cases, with respect to Ranbaxy. Here is an excerpt:
“The real story is how poorly our government has responded to all of this,” says Vincent Fabiano, Ranbaxy’s former vice president of global licensing. He’s one of a number of former company executives who spoke to FDA or other investigators about the company and then watched in increasing disgust as, for years, nothing seemed to happen. “Still as we sit here today,” Fabiano says, “Ranbaxy is in business in the United States.”
Editor’s note: The honor system, the process of self-regulation, etc., etc., etc. These all provide covers from criminogenic activity. Yes, there are companies and people with honor but all too many have no compunction about fraud. At the very least we should follow the admonishment of Ronald Reagan (when talking about nuclear weapons bans):
Source:
- Dirty Medicine (Katherine Eban, Fortune, 15 May 2013)
