Thursday, May 23, 2013

Would you buy Ranbaxy's drugs?

If there's just one thing you read this week or even this month, read this long and damning article over at Fortune about Ranbaxy and the fraud for which it actually paid USD 500 million. I'll leave you to your own conclusions, but I couldn't resist making a list of some of the most damning lines from the article. And after you finish reading the article, tell me this:

a) Would you be comfortable buying Ranbaxy's drugs ever again?
b) Would you be comfortable buying any Indian manufacturer's drugs? 

For as I read the article, I nodded along. All the while. That is how it is in India. And not just pharma, every manufacturing industry has companies like this, yes? No documentation, forged stuff, backdated stuff, cutting corners wherever possible. 

I hate the word jugaad. I hate what it implies, I hate its connotations. People have written whole books about it and it just makes me sad. Jugaad is alright as long as its temporary. Jugaad isn't permanence. It shouldn't be. Jugaad just means that the system got so bad and so out of hand that you had to do something, anything just to get the slightest amount of work done. Jugaad means you've given up on the system or what's more likely, there's no system in the first place.

I'm not sure where I'm going with this. Here are your quotes:

  1. On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn't meet specifications, and making intentionally false statements to the government.
  2.  It is not a tale of cutting corners or lax manufacturing practices but one of outright fraud, in which the company knowingly sold substandard drugs around the world -- including in the U.S. -- while working to deceive regulators. The impact on patients will likely never be known. But it is clear that millions of people worldwide got medicine of dubious quality from Ranbaxy.
  3. 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.
  4. The company manipulated almost every aspect of its manufacturing process to quickly produce impressive-looking data that would bolster its bottom line. "This was not something that was concealed," Thakur says. It was "common knowledge among senior managers of the company, heads of research and development, people responsible for formulation to the clinical people."
  5. 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.
  6. The confidential report laid bare systemic fraud in Ranbaxy's worldwide regulatory filings. It found that "the majority of products filed in Brazil, Mexico, Middle East, Russia, Romania, Myanmar, Thailand, Vietnam, Malaysia, African Nations, have data submitted which did not exist or data from different products and from different countries ..." The company not only invented data but also fraudulently mixed and matched data, taking the best results from manufacturing in one market and presenting it to regulators elsewhere as data unique to the drugs in their markets.
  7. Sometimes all the data were made up. In India and Latin America, the report noted the "non-availability" of validation methods, stability data, and bio-equivalence reports. In short, Ranbaxy had almost no method whatsoever for validating the content of the drugs in those markets. The drugs for Brazil were particularly troubling. The report showed that of the 163 drug products approved and sold there since 2000, only eight had been fully and accurately tested. The rest had been filed with phony data because they had been only partially tested, or not at all.
  8. For its HIV drugs, the report found that Ranbaxy had used ingredients that failed purity tests and blended them with good ingredients until the resulting mix met requirements. Such a mélange could degrade or become toxic far more quickly than drugs made from the high-quality materials required.
  9. Six other pharma veterans who worked for Ranbaxy in the U.S. as recently as 2010 tell Fortune they found themselves in a corporate culture like nothing they'd ever experienced. Executives approached the regulatory system as an obstacle to be gamed. They bragged about who had most artfully deceived regulators. Until 2005 the company didn't even have a functioning patient-safety department, and patient complaints piled up in boxes, ignored, uncategorized, and unreported to the FDA as required.
  10. In entire markets -- including Brazil, Kenya, Ethiopia, Uganda, Egypt, Myanmar, Thailand, Vietnam, Peru, and the Dominican Republic -- the company had simply not tested the drugs and had invented all the data.
  11. Everywhere the FDA had looked, its inspectors found fraud. Four months earlier, at a unit of Paonta Sahib, agency investigators discovered that supervisors who had supposedly overseen critical manufacturing steps weren't even at the plant on the days they signed off on the tests. "The culture of the company was corrupt to its core," says Nelson.
  12. The congressional inquiry into the FDA petered out over the years. But under the direction of David Nelson, investigators interviewed the FDA inspectors who went to Paonta Sahib and asked them a simple question: Would they feel comfortable taking Ranbaxy drugs? "Every single inspector that went to India said they would never take a Ranbaxy drug," says Nelson, "like eight out of eight."They were not alone. One by one, each of the former Ranbaxy executives Fortune interviewed had determined, while still at the company, to stop taking Ranbaxy drugs.
This doesn't cover all the parts, just the juiciest bits. Really though, you should read that article. Even the FDA doesn't come out very well, and it shouldn't. 

Also, here's the official Dept. of Justice press release. You should just go through it, because. And of course, think about these two things as well:
a) The company admitted criminal fraud, and no one's going to jail.
b) How much of this have you heard in the newspaper you read / TV news show that you watch? 

Happy thinking, everyone.