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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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« Ranbaxy: Looking Under the Rock | Main | How Much Do Drug Companies Spend on R&D, Anyway? »

May 17, 2013

A Little Ranbaxy Example

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Posted by Derek

Compare and contrast. Here we have Krishnan Ramalingam, from Ranbaxy's Corporate Communications department, in 2006:

Being a global pharmaceutical major, Ranbaxy took a deliberate decision to pool its resources to fight neglected disease segments. . .Ranbaxy strongly felt that generic antiretrovirals are essential in fighting the world-wide struggle against HIV/AIDS, and therefore took a conscious decision to embark upon providing high quality affordable generics for patients around the world, specifically for the benefit of Least Developed Countries. . .Since 2001, Ranbaxy has been providing antiretroviral medicines of high quality at affordable prices for HIV/AIDS affected countries for patients who might not otherwise be able to gain access to this therapy.

And here we have them in an advertorial section of the South African Mail and Guardian newspaper, earlier this year:

Ranbaxy has a long standing relationship with Africa. It was the first Indian pharmaceutical company to set up a manufacturing facility in Nigeria, in the late 1970s. Since then, the company has established a strong presence in 44 of the 54 African countries with the aim of providing quality medicines and improving access. . .Ranbaxy is a prominent supplier of Antiretroviral (ARV) products in South Africa through its subsidiary Sonke Pharmaceuticals. It is the second largest supplier of high quality affordable ARV products in South Africa which are also extensively used in government programs providing access to ARV medicine to millions.

Yes, as Ranbaxy says on its own web site: "At Ranbaxy, we believe that Anti-retroviral (ARV) therapy is an essential tool in waging the war against HIV/AIDS. . .We estimate currently close to a million patients worldwide use our ARV products for their daily treatment needs. We have been associated with this cause since 2001 and were among the first generic companies to offer ARVs to various National AIDS treatment programmes in Africa. We were also responsible for making these drugs affordable in order to improve access. . ."

And now we descend from the heights. Here, in a vivid example of revealed preference versus stated preference, is what was really going on, from that Fortune article I linked to yesterday:

. . .as the company prepared to resubmit its ARV data to WHO, the company's HIV project manager reiterated the point of the company's new strategy in an e-mail, cc'ed to CEO Tempest. "We have been reasonably successful in keeping WHO from looking closely at the stability data in the past," the manager wrote, adding, "The last thing we want is to have another inspection at Dewas until we fix all the process and validation issues once and for all."

. . .(Dinesh) Thakur knew the drugs weren't good. They had high impurities, degraded easily, and would be useless at best in hot, humid conditions. They would be taken by the world's poorest patients in sub-Saharan Africa, who had almost no medical infrastructure and no recourse for complaints. The injustice made him livid.

Ranbaxy executives didn't care, says Kathy Spreen, and made little effort to conceal it. 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."

I have said many vituperative things about HIV hucksters like Matthias Rath, who have told patient in South Africa to throw away their antiviral medications and take his vitamin supplements instead. What, then, can I say about people like this, who callously and intentionally provided junk, labeled as what were supposed to be effective drugs, to people with no other choice and no recourse? If this is not criminal conduct, I'd very much like to know what is.

And why is no one going to jail? I'm suggesting jail as a civilized alternative to a barbaric, but more appealingly direct form of justice: shipping the people who did this off to live in a shack somewhere in southern Africa, infected with HIV, and having them subsist as best they can on the drugs that Ranbaxy found fit for their sort.

Comments (43) + TrackBacks (0) | Category: Infectious Diseases | The Dark Side


COMMENTS

1. MTK on May 17, 2013 8:20 AM writes...

That's about as bad as it gets

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2. Nick K on May 17, 2013 8:30 AM writes...

Despicable and blatantly criminal conduct by Tempest and Singh. Why has the DoJ not prosecuted them yet? Why is Ranbaxy still permitted to trade in the US?

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3. alig on May 17, 2013 8:52 AM writes...

It seems like the worst conduct was not in the USA. The US fined them $500 million. The other countries should fine them according to the crimes in those countries. If Ranbaxy got 50 or so $500 million fines, maybe that would be a wake up call.

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4. Evans' Dog on May 17, 2013 9:15 AM writes...

Folks, this is how Indians do business. Bend the rules, break them etc..

Ranbaxy should be banned from selling drugs. Indian CROs' are suspect at best. why take that risk.

The law is weak in India and other countries.

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5. Anon on May 17, 2013 9:23 AM writes...

I wonder what these individuals have done in the past at their previous workplaces.
This is another unfortunate blemish for the pharma industry but more importantly, completely sickening what what has happened to these patients.
"...live in a shack somewhere southern Africa, infected with HIV, and having them subsist as best they can on the drugs that Ranbaxy found fit for their sort." This line really makes me feel for those patients. They thought they were getting one of the best therapies (and were probably very thankful for it). Many of these people may not be alive to realize how they were taken advantage of for PR reasons.

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6. Hap on May 17, 2013 9:41 AM writes...

How severe a crime do you have to commit before one can "pierce the corporate veil" and put executives in jail? If you knowingly sell bad stuff, even if it won't kill your patients directly but will only accelerate their deaths passively, isn't that at least negligent homicide? If not this, then what? Do criminals have to incorporate as "waste disposal businesses" before someone realizes that letting businesses commit homicide without serious repercussions is a bad idea?

I would also imagine that we probably feel similarly to the people in India feel about Bhopal - I know Dow can't go to India, but we're certainly not sending their executives there to stand trial or serve time. I don't see anyone at Ranbaxy going in front of a federal judge for this, unless they're really dumb. I'm sure, though, that if you invited some people from South Africa to Ranbaxy's headquarters, you could solve the problem expediciously.

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7. milkshaken on May 17, 2013 9:49 AM writes...

@4: In a sonnet from John Donne, the God is a bully and has a power to "bend, break, blow, burn and overthrow". Maybe these execs were taught some good poetry in college and now they utilize the imagery when thinking about themselves, in Savile Row bespoke suits and clean, well-chilled conference rooms

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8. petros on May 17, 2013 9:50 AM writes...

Brain Tempest is a chemist
http://www.briantempest.com/cv.htm

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9. Hap on May 17, 2013 9:57 AM writes...

4: You've really got some sort of animus towards the Indians, no? In the last post, pointers to both Glaxo and Genzyme have gotten caught in similar problems (although, one can note, without the comprehensive falsification). China hasn't exactly been innocent either - it wasn't all that long ago that we were wondering whether heparin from China actually worked (or would kill us), whether their cat food would kill our cats, or whether their toothpaste would kill any more Panamanians (and the last one was a replay of the scandal in the US that created the FDA involving diethylene glycol as a cheap substitute for glycerol in analgesic(?) syrup).

So I'm not understanding why you think that Indians are particularly liable to dishonest business behavior; after all, if one posits that a culture lends itself to such behavior, how did Americans get to be any different (since our culture was the one 100+ years ago that would have been subject to such vituperation). Certainly our business behavior would not give the impression that such morals are dead here, just that given enough counterweight, people will mostly do the right things.

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10. milkshake on May 17, 2013 10:15 AM writes...

@9 Hap, as you probably know Indians as whole do not have the highest reputation of research integrity in the chemical community, because of the high frequency of dubious research publications. It is unfortunate to lump whole people or nations together in a statement like this but stereotypes and prejudices do get based on bad experience. For example Chechen militancy has made a name for itself long, long before the Boston bombings

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11. Hap on May 17, 2013 10:37 AM writes...

I know - I guess I am not willing to assume it's just them, though, but a lack of external checks that makes it pay better to cheat than to play fair. "Win at all costs" helps too. Lots of places have that combination.

I knew about Chechnya a while ago - a previous edition of World's Most Dangerous Places describes some Chechnyan...activism in detail. After the bombings, people were thinking that asking Russia for help would be a good idea, and even with the Russians not being all that happy with us, I wouldn't have figured it would take them long to figure out who they hated more.

There used to be lots of Indians in Africa as doctors, until Idi Amin decided "Blame the Indians" was a good way to distract people. I guess memories are short.

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12. Anon on May 17, 2013 11:17 AM writes...

Indian generic counterfeiters, Chinese toy counterfeiters, American financial counterfeiters, looks like every country has its favorite brand.

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13. Hap on May 17, 2013 11:36 AM writes...

It does seem more cold and calculated than lots of fraud, though - Ranbaxy's big enough that the fraud had to be thought about, and pondered, and agreed upon. It doesn't seem like that combination of mass calculation and lack of conscience (even when you rob people, they don't necessarily die afterwards) happens very often.

I wonder how many people would be buying Fords if a Ford executive had said about the Pinto, "Well, it's just {blacks/whites/pick your favorite racial or cultural epithet} dying in our cars." I'd go so far as to wonder how many Ford executives would still be alive after such comments.

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14. Evans' Dog on May 17, 2013 11:55 AM writes...

@ Hap -- I am an Indian. Hows that for irony !!

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15. Evans' Dog on May 17, 2013 11:59 AM writes...

@ Hap -- I have knowledge of the way the indian system function. In india you can launch a NCE without safety and efficacy -- as long as you know to fabricate and grease appropriate palms.

Ranbaxy and Glenmark and Dr. Reddys started out in this setting. Now that they are looking at western markets -- they have tried hard to conform. but a dogs' tail cannot be straightened.

I am not saying that Indians are alone in this regard. But I have knowledge and experience in the indian system. maybe the Chinese system is no different.

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16. Anonymous on May 17, 2013 12:03 PM writes...

Cook meth in your room - 20 years in the slammer.

See phony medications to millions, get a slap on the wrist.

Something tells me our "Justice" Department has their priorities fouled up!

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17. anon on May 17, 2013 12:04 PM writes...

@ milkshake...then there are many retractions from China (too many to speak of), Americans (Breslow, Sames) and the list is long! But, I agree with your larger viewpoint.

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18. Evans' Dog on May 17, 2013 12:08 PM writes...

a former Ranbaxy exec started a CRO called ADVINUS. why are US firms signing deals with this CRO ??

Do they want to get burned by another fraud ?

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19. Hap on May 17, 2013 12:17 PM writes...

I wonder how eager insurance companies would be to pay for drugs from Ranbaxy knowing their emphasis on (cough) quality. You could still get burned by another generic company (particularly if the FDA can't inspect them often, either), but the devil you know (not so much hyperbole, alas) is probably better than the one you don't. Cutting Ranbaxy off from that teat would probably put a crimp in their financials.

I'm not sure if this is a liberal or conservative failure (or both, or neither), but it's a failure. If the FDA can't or won't inspect facilities elsewhere often enough to make them think more than once about cheating, well, then guess what's going to happen.

17: Fair enough.

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20. emjeff on May 17, 2013 1:54 PM writes...

"It's just blacks dying."

That is just about the most chilling thing I have ever heard. These guys deserve life in prison.

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21. robopox on May 17, 2013 2:10 PM writes...

I take 3g/day of valcyclovir to suppress disseminated HSV.
And it barely controls the neuritis, and Mollaret's meningitis.

I wonder if the Ranbaxy label on the "we only pay for generic"
prescription has anything to do with this?

Miserable, lying, rotten SOB's!

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22. PharmaHeretic on May 17, 2013 2:39 PM writes...

@emjeff

I am surprised that you pretend to be shocked by what those Ranbaxy executives said. But is what they voiced really that different from what a lot of white americans and europeans think every single day. I do agree that such opinions are now seldom voiced publicly in western countries- but talk is cheap and meaningless. The real question is who did what and who did not do anything.

Specifically- Why weren't western companies filled with people of the 'right' skin color and 'superior ethics' supplying inexpensive medicines to people with AIDS in Africa? If whites in western countries really believed that people in Africa were as human as them- they would have stepped in to help. But they did not because.. well, you know the answer.

I am not defending what those morons at Ranbaxy said or did, but at least they made a half-hearted attempt to help or did a better job pretending to do so.

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23. MTK on May 17, 2013 3:19 PM writes...

PharmaHeretic,

While you are not far off-base I do believe there's a difference.

If we, as in Europe and America, ignored their plight, then the other willfully and fraudulently exploited it.

It's one thing to not do enough. It's another thing entirely to pretend like you are and preach like you are when in reality you aren't and enrich yourself in the process.

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24. DocNas on May 17, 2013 4:24 PM writes...

As a South African doctor who regularly prescribes Ranbaxy drugs, I'm more than a little shocked, a little like gagging on my own tongue. I agree with MTK, this is hypocrisy: I don't know believe there was ever any altruism in providing ARV's to subsaharan Africa. It's just money money money.
As for the "just blacks" comment, of course its racist through and through (I'll also mention that I'm of subcontinent descent myself).
But tell me, you Americans and Europeans, how is that different to the average Euro/American corporation who is both driven by greed, firstly, to the detriment of integrity, and secondly to the common US or European attitude of considering a black or a Muslim life (whether it be in or out of their nations) as inferior in value to a white one?

This is a showcase of corporate greed. Integrity is dispensable where money needs to be made. And THAT's universal.

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25. Tom Womack on May 18, 2013 7:18 AM writes...

To what extent does the FDA repeat equivalence-testing between name brand and generic drugs? It seems as if the Renbaxy problem would have been caught as soon as a mystery-shopper with a HPLC setup did a careful comparison of what was in their tablets and the name-brand, and that sort of testing has the great advantage that it can be done by US federal employees in the US with limited influence from Renbaxy.

Are there any plans to get more aggressively adversarial in that direction?

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26. processchemist on May 18, 2013 8:15 AM writes...

Ranbaxy is not the first company to make profits with the poor, and as we all know, their behaviour maximize profits. I wonder how many western managers dream about no controls, no laws , no regulators - the best way to deliver value.

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27. newnickname on May 18, 2013 12:55 PM writes...

@22 PharmaHeretic: I also disagree with the comparison. A Big Pharma can refuse to sell at a cheaper price or even refuse to give away life saving drugs for free. (Merck still (25+ years) fully funds the distribution of FREE ivermectin for river blindness.) Big Pharma can shift the blame to governments or humanitarian NGOs and say it is they who refuse to pay the higher price for those drugs. Thus it is perhaps the gov's and NGOs who thus put a comparative price on human life and refuse to raise taxes or charge higher fees. And the NGOs might blame their donors for not contributing enough money and that it is the donors who value the lives of the poor so cheaply. And so on, down the shifting line of blame and responsibility.

It is quite another thing to knowingly sell adulterated, ineffective medicines cheaply but still at quite a profit.

I hope that there are laws someplace (US, India, Union of S Africa, maybe the World Court?) that would allow Ranbaxy executives to be charged and prosecuted (and, if found guilty, severely punished).


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28. pgwu on May 18, 2013 3:54 PM writes...

A few years ago, a former head of Chinese SFDA was sentenced to death for accepting bribes in approving fake drugs with fake data. It seems that there are places where you do not even need bribery to submit fake data and get drug approval. Regulatory loopholes or open secrets?

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29. yetanotheranon on May 19, 2013 12:53 PM writes...

To quote one of my more cynical classmates in grad school,"There's no money in curing people in the Third World. It's all about curing people in the First World & exploiting people in the Third World as labor and guinea pigs."

Along these lines, a movie that might be worth watching is "The Constant Gardener".

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30. Anonymous on May 19, 2013 6:45 PM writes...

"Who cares?" he said, according to Spreen. "It's just blacks dying."

I am feeling nauseous... These folks deserve jail time for sure. The DoJ need to pursue this beyond issuing a simple fine. Alternatively, any organization with such shoddy business practices should be completely banned from selling drugs in the US...

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31. Brit on May 19, 2013 8:20 PM writes...

Before we all start blaming the Indians, let us remember who was in charge. Brian Tempest (sadly I have to say a Brit) seems to have been the CEO at the time and still sells his services on the web.

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32. Lightin' a candle on May 19, 2013 11:56 PM writes...

Let's do what we do test the pills!

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33. sepisp on May 20, 2013 3:22 AM writes...

In India, the whole Weltanschauung is based on a class system. For instance, already in their religion, people are born into higher and lower castes. There is no need to feel sorry for the less fortunate. Thus, their conduct is not immoral, according to their ethics. So, globalization good, Western cultural imperialism bad?

I saw a documentary about dyeing textiles in India. The workers stood in the acidic chemical baths wearing no protective gear at all. The fumes shortened their lifes dramatically. When the (Indian) manager was questioned about this, his response was absolutely impudent, clearly from someone who knows a priori he's right: "You don't understand. These are very simple people." I can never forget that phrase, "very simple people". It means that *because* they are poor, they *should be* treated with contempt. There's no trace of humanity left in that world view.

Alternatively, you could say Ranbaxy's execs are like Hans Landa, realistic to the point of being inhuman. This explanation doesn't need invoking the "they're Indian" card.

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34. anonymous on May 20, 2013 5:10 AM writes...

"and secondly to the common US or European attitude of considering a black or a Muslim life (whether it be in or out of their nations) as inferior in value to a white one?"

That one's easy. That attitude doesn't exist anymore, or is not as common in educated people who get degrees/make drugs, as you think it is. This is because you are ignorant since you don't live in a 'white' country (whatever that is) and your view of Western countries is based on a dumbed-down version you get from some propaganda, post-colonialist news source. Your welcome.

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35. Anon on May 20, 2013 7:11 AM writes...

You think this kind of inhumanity is limited to Indians (and nobody doubts they should be punished for it)? You can pick any number of episodes from Western history and countries where people were as condescending or more so to those they considered inferior. What these guys did is unpardonable but let's not pretend that Americans and Europeans never said or did anything similar; let's not forget that it wasn't Asia which invented racism.

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36. Insilicoconsulting on May 20, 2013 7:15 AM writes...

Casteism and religion is still sadly a part of the Indian way of life. I wonder if it will ever go away, although the IT revolution has made a substantial contribution to putting all castes on an equal footing. Moreover, the emerging generation is not as rigid or fundamentalist about caste as earlier, particularly in cities. There's still hope.

Even the instances of child labour and the worker working in an acidic bath or children working in bidi factories, cracker factories exists. But with more awareness, tougher laws and their implementation is decreasing. It will take time but the lot of have nots is improving.

Again remember that class/caste distinction is not that different. Remember low class (white) children and orphans being snatched from their families and deported from the UK earlier last century? Or the lot of the working classes? The treatment of the Roma?

Indians also love white skin! That's why fairness creams sell a lot. But you know what? The same Indian companies also sell the same fairness creams to "fairer non-indians in North and central Africa!

No Indian I know will accept what ranbaxy has done. We too stand to lose a lot from spurious /adulerated/substandard drugs. Loss of national prestige, loss of business, fear for our own safety...

But the question is why should this be taken as symptomatic of the entire indian industry/ pharma, cro in particular and why should indians be blamed in general?

What if companies that FDA has taken action against in the last 2 years were asked to reveal THEIR internal emails? Would you not find similar disgusting emails about HIV drug prices and their economic burden on africans? I bet many nasty things would indeed be found there too. This is just the case of a company that got caught because of a whistleblower..

Agree with Sepisp that the "they're Indian" card is unwarranted.

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37. anonymous on May 20, 2013 9:22 AM writes...

"You think this kind of inhumanity is limited to Indians (and nobody doubts they should be punished for it)? You can pick any number of episodes from Western history and countries where people were as condescending or more so to those they considered inferior."

No, I don't think that. That's just something you made up that you think that I think. I don't care about historical discussions when the accusation was made that in Western countries 'right now' white people think less of those with other skin color or religion in general. This assertion is either ignorant, or it is a lie and racist in itself.

As to what I think of Indians... Well, I'd like to point you to the article which Derek links too, where two of Ranbaxy's Indian executives discovered all the problems and one of them became the whistleblower who emailed the FDA repeatedly. These are fine individuals and you will find good individuals in any society. As well as bad ones that will cut corners and those who will make generalizations about any group of people in a country they haven't lived in or don't know much about.

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38. Provocateur on May 20, 2013 10:23 AM writes...

I am an Indian and want to address the notion that Indians are just more corrupt than others.The India judiciary system is broken for the common man.So a parallel system has been put into its place.Money has taken its place.Ranbaxy is another manifestation of it.I am sure the medicines do their job but as there is no regulation/certification there is fear surrounding it.There still has been no deaths or any civil cases filed by any patients here in the USA.If the Indian companies were not there in Africa think of its effect on the HIV epidemic.There is a lot of good there.

That said, India is changing.There is a huge anti-corruption sentiment and the society is open.Things will change for the better but at a snails place

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39. Anonymous on May 20, 2013 11:28 AM writes...

@Provocateur:

"There still has been no deaths or any civil cases filed by any patients here in the USA."

Give it time. If there's one thing we're famous for here, it's our litigious nature. I would be surprised if there's not more than one law firm trying to set up a class action lawsuit against Ranbaxy as I write this. And based on what I read in that article, they deserve it too. And I hope some of those poor people in Africa get in on it too. I can also imagine that there are a bunch of HIV charities that aren't too pleased with Ranbaxy right now either.

But I'd also sort of like to echo the dismay of others above in how such a company can still be allowed to sell drugs here in US or anywhere else for that matter. I don't think $500 million is nearly enough to change their business practices. I'm guessing it's business as usual there right now and nothing will change.

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40. anonymous on May 20, 2013 11:53 AM writes...

I'm the anonymous from 9:22.

"If the Indian companies were not there in Africa think of its effect on the HIV epidemic.There is a lot of good there."

If Indian companies were not there, then Teva or someone else would be there. They would charge probably twice as much, but at least you wouldn't be getting dodgy drugs. Though, who knows. Indian companies were not filling a vacuum, they were just undercutting the competition with better prices and quality, or so it seemed at the time.

"That said, India is changing.There is a huge anti-corruption sentiment and the society is open.Things will change for the better but at a snails place"

That's good. But it's not good to say 'snail's pace' as that's a bit like an excuse. Things have to be forced to move as fast as possible. The benefits will be more than worth it.

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41. Anonymous on May 21, 2013 9:42 AM writes...

@35 Anon: "it wasn't Asia which invented racism." has got to be one stupidest comments I've ever read on this site. Racism, slave trade, and a whole slew of human abuses and horrors seem to have arisen independently in every corner of the world over the last 10,000 (or so) years of civilization. Western education is dominated with Greek/Roman roots (slavery, religious persecution ... democracy) but it was everywhere (... except for the democracy part).

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42. bacillus on May 21, 2013 12:13 PM writes...

Just last week, I had a call from my pharmacist telling me that my son's generic Seroquel from China was contaminated with antibiotics. They were phoning to ensure he wasn't allergic to it. How are we supposed to have any confidence about what's actually in the generic prescription medicines we're taking?

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43. sepisp on May 22, 2013 4:13 AM writes...

My point was not trying to be racist or blame all Indians. I am merely interested in the motives, or what's going on inside the head of these execs. In most people, doing any sort of evil is prevented by various counter-pressures, such as honor, integrity, self-image or even just conformity, guilt and fear of punishment. Evil is done when these are absent or pushed aside. But, if their ethics has a "casting defect", then this conduct does not breach honor, integrity, self-image or desire for conformity, nor cause guilt, and most likely there is no reason for fear of punishment either.

This "casting defect" may in principle occur anywhere, but it is more likely in cultures based on "inherent" superiority (by birth) rather than "acquired" superiority (by merit).

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