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Saturday, August 10, 2013

Regulation without integrity is doomed to failure

Every year there are a handful of stories which really shake my confidence. Today, I read one . (Ranbaxy)  An investigative story published on the CNN Money website attributed to Fortune Magazine describing a truly sordid tale entitled "Dirty medicine" (by Katherine Eban).

Ranbaxy is a veritable generic drug giant in which the Japanese Pharmaceutical Company Daiicho Sankyo has a controlling interest. They purchased this in 2008. However, four years earlier employees of Ranbaxy publicly drew attention to the fabrication of drug testing reports within the company. The fraud did not appear to be isolated, but affected perhaps every drug and market that Ranbaxy was involved with.

As noted in the Fortune piece, 80% of the active pharmaceuticals used in the US come from outside of the country. The level of oversight is inherently less in countries such as India than it is in the US or Europe. The lesson of the story is clear as noted in the Fortune piece:
As the Ranbaxy story makes vividly clear, generic-drug makers intent on breaking the rules -- especially those operating abroad -- can easily do so. Drug applications work on the honor system: The FDA relies on data provided by the companies themselves. "We depend on that information to be truthful," Gary Buehler, who headed the FDA's office of generic drugs for 10 years, said in December 2009. (Buehler has since taken a position at the U.S. unit of the Israeli generic-drug company Teva.) The approval system "requires the ethical behavior of the applicant," he said. Otherwise, "the whole house of cards will fall down."
The particulars were described in detail in the article. Rajinder Kumar and Dinesh Thukar were Ranbaxy employees previously employed by brand name pharmacuetical firms who were lured back to India and Ranbaxy to assume leadership posts. They had little idea of what they were getting into.

In August 2004, as he confronted his assignment to investigate possible fraud at his own company, Thakur gave each of his project managers a part of the world and asked them to compare Ranbaxy's manufacturing data against the claims made to regulators. His own efforts began with a visit to a company regulatory official.
It was a depressing conversation. The official explained, Thakur says, that the company culture was for management to dictate the results it wanted and for those beneath to bend the process to achieve it. He described how Ranbaxy took its greatest liberties in markets where regulation was weakest and the risk of discovery was lowest. He acknowledged there was no data supporting some of Ranbaxy's drug applications in those regions and that management knew that, according to Thakur...... 
The entire article is worth reading. I don't think it makes sense to copy it in its entirety into the blog post. Each section is simply remarkable in terms of the reported brazenness of Ranbaxy management. For example:
Lying to regulators and backdating and forgery were commonplace, he says. The company even forged its own standard operating procedures, which FDA inspectors rely on to assess whether a company is following its own policies. Thakur's team was told of one instance in which company officials forged and backdated a standard operating procedure related to how patient data are stored, then aged the document in a "steam room" overnight to fool regulators.
Company scientists told Thakur's staff that they were directed to substitute cheaper, lower-quality ingredients in place of better ingredients, to manipulate test parameters to accommodate higher impurities, and even to substitute brand-name drugs in lieu of their own generics in bioequivalence tests to produce better results.
I don't even know where to begin. A complex world and the human interactions required to make this work are so based upon trust. When you go into a restaurant for a meal, there is a large degree of trust. Yes, there is a health department inspection report somewhere but that can only go so far. When patients see a physician or dentist, there is trust that medications are correct and instruments are clean. Every few years there are revelations about this practice or that where operations are substandard. They may reach a few hundred or perhaps a few thousand people. The Ranbaxy situation was orders of magnitude worse, perhaps affecting tens if not hundreds of millions of people, many of whom are the most vulnerable in the world.

Within the US  we are strongly encouraged to prescribe generic drugs. This behavior is now assigned the priority as a "quality" metric placing physicians in a position where they are strongly encouraged to write for generics. Talk about unintended consequences. I am very tempted to prescribe with the qualifier that  generics are OK but to avoid Ranbaxy products until they can restore my trust. Good luck to them.

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