Dirty medicine – Long-term criminal fraud at Ranbaxy (2013) | Hacker News Reader

Dirty medicine – Long-term criminal fraud at Ranbaxy (2013)

fortune.com

69 pointsgwern43 comments

This article is a little old, but I'm glad to see it on HN again.

Yes, Western pharma companies do a lot of questionable and outright wrong things, but this story just takes the cake. It's in an entirely different league.

In a conference call with a dozen company executives, one brushed aside her fears about the quality of the AIDS medicine Ranbaxy was supplying for Africa. “Who cares?” he said, according to Spreen. “It’s just blacks dying.”

Not surprising, there are lots of reports on how India is unapologetically racist (which is incidentally, also perhaps why Caucasians are so well treated ?).

A few years ago, a close relative of friend was an Assistant Drug Controller for a particular region of India. As is the case with a huge number of Indian government officials, this guy was corrupt to the core. I was quite aware of how his factory "inspection" reports were aided by greased palms. I imagine that a huge portion of drugs here are shit. My family has been safe so far probably because we go to reputed doctors who prescribe good drugs.

In a way it's ironic that things that are not essential to our lives... like computer products, cameras, mobile phones, etc. have so many review and benchmarking sites. We consumers pore over those reports to help us make the next purchase. The best part is that none of these reviews or benchmarks are mandated by government agencies. But when it comes to drugs that can save our lives, we seem lead our lives mostly in ignorance.

I can't say that I'm surprised; the Government of India more or less carries on in a state of dire paralysis.

Do you see any possible way to bridge this gap, and help people identify and avoid substandard drugs? I am planning to work in patient empowerment, would like any ideas in this regard.

Well, since you are inviting me to speculate, I'll do so.

1. Best-case scenario: high-school kids are imparted with some basic knowledge of drugs. I think they'll understand Pharmacology 101 just fine. This will raise the quality of journalism too because (a.) journalists are better educated to seek out such news and (b.) there is a wider demand for news of greater technical depth. I speculate that UL-like companies will spring up to meet consumer demand.

2. In the present world, I'd be happy with a blog/journal that keeps an eye on pharmaceuticals. Drug Watch[1], for example, focus on just big-pharma and lawsuits. They come off a bit like ambulance chasers. FDA has several feeds [2], but the volume of information is rather high. So, a service that sends out targeted emails would be just fine. So, a user would select a bunch of ailments and drugs, and this service would send emails when there is ab update on any of those. That way, users of lipitor would get updates on Ranbaxy's antics too.

[1] http://www.drugwatch.com/

[2] http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds...

Thanks! interesting ideas. High school level introduction to pharmacology is an excellent point. It will bring in a lot of awareness. Thanks for the pointers on FDA feeds. Your contact is not there in profile. Do you mind sharing your contact info?

I have added my contact info.

Thanks. Hoping you won't mind if I drop a mail.

Okay, this is a serious question.

We just saw a report about how the SEC is too close with banks, and this shows the FDA not doing a good job regulating drug companies.

Can someone point to a good US regulatory agency? Like one that operates well, isn't scared to use it's powers aggressively, and so on?

The closest I can think of is the Justice Department going after voter surpression.

Regulatory capture happens to every regulatory agency, as a general rule. Hiring zealous staff who want to maintain the mission of the regulatory agency is not easy to do.

http://faculty.haas.berkeley.edu/dalbo/Regulatory_Capture_Pu...

http://www.tobinproject.org/books-papers/preventing-capture

Perhaps the regulators should be rewarded with the kind of money that they'd never need to work again if they uncover significant violations, and the company should be fined a similar amount and shut down, with involved people put in prison? Seems like a solution.

Also, you'd get a lot of very zealous people applying for those jobs. Heck, you could probably quadruple the inspection teams just with people willing to take low salary and treat it like playing the lottery.

You do see the occasional case like Thalidomide, which is an amazing story of how Dr. Kelsey saved Americans from a very dangerous drug (prescribed for morning sickness, but caused terrible birth defects) which had a hand in transforming the FDA into the agency it is today. She was awarded the President's Award for Distinguished Federal Civilian Service, but I don't know about any cash windfall for doing such great work.

Doctors and regulators in the FDA who protect the public from these drugs / drug companies are heroes. Perhaps it's not just the whistle blowers who should be getting 1/3rd of the settlement, but another portion should be set aside for performance awards for key people who made the case.

Frankly though $500m wasn't enough. $5b would have properly shuttered this rotten steaming pile of a company.

While the consequences where certainly devastating don't be so fast to demonize Thalidomide.

It's currently having a comeback and showing huge promise for cancer treatment:

http://www.mayoclinic.org/diseases-conditions/cancer/in-dept...

It wasn't my intention to demonize thalidomide, or any of its many derivatives.

You're right it's an effective (although very expensive) cancer treatment. At least a prescription now comes with a strict program to try to prevent exposing any fetuses. A far cry from a treatment for morning sickness. I can't get over the audacity of Gruenenthal (the German company who sold it). At least they finally got around to apologizing: http://www.bbc.com/news/health-19443910

I am waiting for someone to pour out the cons here. But why not align incentives with expertise.

Allow companies to test others' products, if they find serious problems then any fines resulting from a resulting FDA investigation are split between the govt and the company that found the issues. With generics there cannot be that much "This is a trade secret" since it is already in the open.

I am sure they would be falling over each other to cripple the competition.

Fire away.

Then you are shifting regulation to cover testing for collusion.

I think one of the issues is that fines need to be huge, penalties painful, and decisions punishing to companies who get caught doing wrong.

CEOs need to be held responsible in the same way that Navy Captains are held responsible: they're responsible for everything that happens under their command. If they don't govern to prevent this, then they need the probability of jail and ending their careers.

"Accountability" is paraded around a lot these days when dressing up a commpany in buzzwords. Our employees are accountable. I'm accountable. You're accountable.

Starting sending CEOs and CXXs to jail, and it will stop.

I dunno but doesn't the FAA do a fairly good job? I suppose failures in air flight result in obvious, immediate, disasters so it's a bit easier to keep everyone accountable.

I am pretty surprised that this Indian company got away with so much and just kept going. What did the FDA have to lose? Was this big in the mainstream news?

The FAA does a pretty good job, but internally they treat their employees pretty poorly, which in turn results in quite a bit of slip. You just don't always see it because it's caught by employees who ARE invested in their careers and in flight safety in general.

There was a story here not so long ago about how the FAA relies on voluntary reporting of near misses, and so fail to act before an outright disaster occurs.

I've always had respect for the FDIC. Its former director, Sheila Bair, wrote a good book about the 2008 financial crash, "Bull By The Horns", and in there she has a lot to say about what makes for good regulation.

I think one the problems the US has had in the last couple decades is a lot more talk along the lines of "government isn't the solution, government is the problem". This can be a useful critique in particular instances. But when it's a general slogan of people in charge of government, it becomes a self-fulfilling prophecy.

The article is about an Indian drug company operating in India. Why the specious attempt to make this about the US?

What blows my mind is that time and time again we call ourselves a developed nation and still allow companies like Ranbaxy to play around with the health of our and the world's citizens.

And Ranbaxy - how can people there sleep at night. How

> still allow companies like Ranbaxy

The same we still allowed companies like Bayer to do this: http://en.wikipedia.org/wiki/Contaminated_haemophilia_blood_...

The same we still allowed companies like GlaxoSmithKline to do this: http://www.bbc.com/news/business-29274822

> Ranbaxy - how can people there sleep at night.

The FDA, Bayer, Pfizer, Ranbaxy, big pharma will always sleep well. http://articles.mercola.com/sites/articles/archive/2006/08/0...

There have definitely been ethical lapses at many large pharma companies. Ranbaxy seems in a different class altogether, though.

Incidentally, Mercola.com is absolutely not a reliable source of medical information. See http://en.wikipedia.org/wiki/Joseph_Mercola. Ironically, Dr Mercola has also suggested that HIV is not the cause of AIDS.

In addition to what me_again said I'd like to draw your attention to the fact that Mercola is one of the most prominent and virulent anti-vaxxers around.

Not sure if you're making your case with a link to his site.

Pfizer had similar ethical failures in trialing a meningitis drug in Nigeria.

http://en.wikipedia.org/wiki/Abdullahi_v._Pfizer,_Inc.

They used a forged certificate of ethics from a hospital, didn't obtain informed consent from those they were treating, deliberately used a 'substantially lower' dose of the alternative treatment and then hid behind lawyers for 15 years to avoid a payout.

The Washington Post did a series of very good articles on the problem;

http://www.washingtonpost.com/wp-dyn/content/article/2006/05...

They used a forged certificate of ethics from a hospital

Pfizer didn't use forged certificates, the Nigerian doctor overseeing the trial forged the certificate.

I'm not saying Pfizer is without fault here, but it's a pretty complex situation.

Not really defending Pfizer here, but this seems not even remotely in the same ballpark as Ranbaxy.

"I don't understand why the company is still in business" is even an understatement. I don't understand why the Board of Directors and pretty much the entire executive team isn't behind bars.

You know HN ops, I chose the title quote I did for a reason: because it emphasizes an aspect which has become very relevant to Americans recently - the lack of interest and disdain in African health which is currently rather backfiring on us in the form of Ebola escaping its shackles.

What was the title you gave btw?

From OP's statement, I'm guessing it's the end of:

> “Who cares?” he said, according to Spreen. “It’s just blacks dying.”

If so, I'd call it blatant editorializing.

I really appreciate the submission, it's a great piece of journalism, and a truly important story, but that does sound a bit like editorializing.

I'd say far more than "a bit" of editorializing, given that 99% of the article has nothing to do with HIV drugs in particular nor the race of consumers.

I have a chronic disease that require regular check ups. My neuro, a very experienced lady, always tells me that she can instantly spot when a patient is taking a generic. I have always thought that she was showing off. Well, maybe not.

At least in times past this has been frequently true with conventional anti-convulsives, drugs that prevent epileptic attacks.

I'm curious: when getting medicines at my pharmacy (in the US), how can I make sure I'm not getting Ranbaxy medicines? Is it as easy as telling the pharmacist?

Wal-Mart, at least, and the mail order units of the Medicare Part D drug plans I've been using for a while tell you who makes the drug. Part of their helping you double check that the dispensed the right one, they also mention the markings on the pills.

Note that the Indian firm Sun bought most of Ranbaxy, given the brand damage to the latter I have to wonder about the 1-2 Sun generics I'm taking right now.

My doctor was certainly happy when I reported, after those two drugs recently went generic, that to my observation the generics had about the same effects.

Absolutely disgusting that this company remains in business.

I'm curious about Teva, they are the other large (and foreign-owned - Israel) generic manufacturer selling in the US.

I don't follow this closely, unless I'm on a maintenance drug supplied by one of these companies, but as I remember Teva has at least an "OK" reputation. At the top at least they don't have the myriad pathologies that are endemic in Indian companies.

For more, read the article: from the very top down Ranbaxy was a totally fraudulent operation, and any similarity between what they claimed to be manufacturing and what they actually delivered was fairly accidental.

Business? It's quite simple. It's other people's money.

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