No Constant Gardener in Sight

We know well about the outsourcing of glittering hi-tech jobs to India and manufacturing ones to China. The justification is the easy availablity of well trained, hardworking, disciplined labor forces willing to work for less than the average worker in the west.  What is less well known is that these hugely populous nations, with large numbers of uneducated rural poor are also the "beneficiaries" of another kind of outsourcing. One that neither the Indian and Chinese, nor the western governments want to advertise from the rooftops. These countries serve as guinea pigs for western pharmaceutical companies, with the consent of the host governments. Phase III drug trials for diabetes, stroke and other diseases, requiring thousands of "volunteers" are conducted in India, China and Brazil on the mostly uneducated, probably unsuspecting and definitely unsophisticated rural poor. To attract the fees associated with human clinical trials, the Indian government has recently relaxed restrictions that used to earlier require companies to demonstrate the safety of the drugs in  phase I and II trials. The drug testing is conducted with little oversight and the lure of money and perks for participation, like holidays in Hawaii, is turning several local doctors into enthusiastic "researchers".

The town of Sevagram in central India has long been known for three things: its heat, which is oppressive even by Indian standards; its snakes, which are abundant; and its ashram, a derelict and increasingly malarial retreat preserved as a tribute to Mohandas Gandhi, who lived here... Last year, Sevagram began garnering even more cachet. A German pharmaceutical company called Boehringer Ingelheim, whose latest stroke-prevention drug was making its way through the clinical pipeline, approved the town's hospital as a trial site......

[D]eveloping countries have been scrambling to catch Big Pharma's eye - India most aggressively of all. Like high tech call centers and software farms, which were meant to transform India's computer industry by creating skilled workers and a stockpile of modern equipment, drug trial outsourcing is seen as the fast route to economic and scientific growth - a money train that the country can't afford to miss. With this in mind, the government is working to advertise India's most pharmacologically appealing qualities, notably its doctors (English-speaking and educated abroad) and its vast number of ailing patients - 32 million diabetics alone. Many of these patients are also, in the delicate parlance of the drug world, "treatment naive," meaning they've never taken any medication for their illnesses. This is a perk for trial managers, because it lowers the risk of unforeseen drug inter­actions and avoids the troublesome process of weaning patients off one medication and onto another.

Last year, the government took a more controversial step, amending a long-standing law that limited the kind of trials that foreign pharmaceutical companies could conduct. That law allowed companies to test drugs on Indian patients only after the drugs had been proven safe in trials conducted in the country of origin. In January, the government threw out that constraint. India, the brilliant hub of outsourced labor, was positioning itself in a newly lucrative role: guinea pig to the world.

Rest of the story here.

Comments

[Sanjay]

Ruchira,

I came to your blog via Sepia Mutiny and, having tracked it for a couple of days, I see that you hold a generally negative view of India's current growth & development.

From what I can gather, the main reason for your disaffection seems to be its resultant inequality i.e the rich getting richer etc. Is this accurate? if so, how do you explain World Bank's numbers (which applies the same calculations for all nations) that show that income distribution in india is better than it is in the US, China, Brazil & not that far away from Germany, Canada, UK etc?

Curious,
Sanjay

[Ruchira Paul]

Sanjay:

I am glad you found my blog. I hope you will visit regularly.

I do not hold a negative view of growth & development in India - or anywhere else. I do frown upon the exploitation of the poor and the ignorant in order to fill the coffers of big corporations and big pharma in India - and everywhere else. If you read my posts, most of which are NOT about India, you will get the picture.

I plead ignorant to the World Bank numbers regarding income distribution. I will take your word for it that the numbers for India are no more alarming than the other countries you name. That however does not contradict the fact that the raw number of poor in India is still very large. A 350 million strong middle class (the number quoted by several sources)still leaves nearly 650 million below that privileged level. India's progress can be counted in several ways. It depends on whether you want to focus only on how much of the glass is full or also pay attention to how much of it is still empty. There is no doubt that the upward movement in living conditions is significant since I left India. However, would you contest that India is still a majority "poor" nation? That the glass is more than half empty? In spite of its impressive growth rate? That it will be a long time before a majority of Indians enjoys the fruit of this growth?

Here is my problem. India should by all means sell and promote its assets as it does in the hi-tech sector or wherever else it has a competitive edge. But why exploit the "naive" poor by subjecting them to drug trials of questionable value which may be ineffective at best and harmful, even lethal, at worst ? And even if India is being opened up for the trials, why not keep in place the same safety measures that the FDA demands in this country? That the Indian government decided to relax these standards, demonstrates either an unseemly greed or an equally disturbing disregard for the value of its own citizens' lives. And these drug trials have nothing to do with India's growth and development. Much more significant and laudable was the fight (now abandoned) by the Indian government and indigenous pharmaceutical companies against unfair patent laws and prohibitive costs of life saving drugs as dictated by giant western pharma. Success in those efforts would have much better contributed to "growth and development" benefiting all Indians, in my
opinion. Wouldn't you agree?

[Sanjay]

Ruchira,

From your posts, I see you championing the cause of the poor & downtrodden everywhere & I honestly do commend you for that. This is perhaps why I'm a bit surprised by your seemingly negative take on the outsourcing phenomena. Note that each IT job outsourced to India creates at least 2.5 additional "official" jobs & some unofficial ones like housemaids, chauffers etc.

In India, where veggies, lentils, rice, wheat etc cost 10 cents/lb & a single egg costs 4 cents, a person making a dollar a day will have enough to eat, if not a "pukka" roof over their head.

Btw, here are the World Bank numbers (2004) I referred to earlier:

Income share held by highest 20% of population:

India 41.6%
Germany 38.5%
United Kingdom 43.2% Brazil 64.1%
China 46.6%
United States 46.4%
Canada 39.3%

Income share held by lowest 20% of population:

India 8.1%
Germany 8.2%
United Kingdom 6.1%
Brazil 2.2%
China 5.9%
United States 5.2%
Canada 7.5%

I post these numbers to make a point about sustainability without prejudice against any particular country. I think these numbers augur well for the long term sustainability of India's growth. Why do I say that? Because it is well understood that fast growing economies display a greater disparity in income levels since the benefits of growth have not had time to spread out through the rest of the economy. India's income distribution profile is not substantially different from that of a stable, low growth, developed economy like Germany or Canada. By contrast, note the income disparity in Brazil, another fast growing economy. Is it any wonder that Brazil has elected a Leftist government? a govt. which will raise taxes, raise social spending etc - all those things that inhibit growth. Hence, one could conclude that brazil's growth is unsustainable.

I agree with you about the sheer numbers of poor in India, although I'm not sure it is 650 million. With poverty level defined as less than $2 per day, the number below the poverty level is estimated to be 200-250 million. Keep in mind that no official estimates of poverty and unemployment exist beyond 1999-2000, the last time India did a survey on household consumer expenditure, labour force and employment.

I do want to redress the misconception that this point may have raised

"That law allowed companies to test drugs on Indian patients only after the drugs had been proven safe in trials conducted in the country of origin. In January, the government threw out that constraint"

India modified its laws only after the guidelines in India have matured to the level demanded by International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), FDA, and European and World Health Organisation recommendations. In fact, the new standards given by the Health Ministry are in some ways even more stringent than the ICH guidelines.

[Ruchira Paul]

Sanjay:
Thanks for the fact filled comment. I am not disputing any of the numbers and data that you present. Nor am I questioning the fact that certain segments of Indian society are indeed beneficiaries of the sharp rise in the standard of living compared to twenty years ago. As I said, you and I are looking at different parts of the same jig-saw puzzle. We just have different perspectives of the overall state of things.

As for my having a negative view of the IT boom due to out-sourcing, where did you get that? Have I said that in any of my posts? I doubt it. I don't know enough about this phenomenon to have that opinion. Many others in the IT business here and in India will be able to comment more knowledgeably. I do know that a large number of Indians have flourished because of this boom, as also no doubt have the service industries which cater to their increased consumer needs. Nothing wrong there at all. What I HAVE said is that it does not tell the WHOLE Indian story as cheerleaders such as Thomas Friedman would like us to believe and as I point out in my previous comment.

I am intrigued by the information you provide about the ICH, FDA and WHO recommended rules supplanting the previous guidelines regarding drug trial safety in India. I am going to ask some Indian lawyers of my acquaintance conversant with such matters for further elaboration. But Sanjay, even if these guidelines turn out to be as stringent on paper as you say, I am still not convinced that they are in practice better than the laws which were in place earlier. Here is why.

The earlier laws required that the drugs be shown as "safe" in Phase I and II trials in "the country of their origin". Guess what that meant. The drug companies had to test them in the US, Germany, England etc. under US, German and English laws where due to consumer awareness and liberal laws governing consumer drug safety and huge awards for punitive damages for pain and suffering, pharmaceutical companies would be very diligent in following all precautions. But in India? Who is overseeing that the guidelines are being followed and under what rigorous quality control? The drugs are going to be tested on members of an unsophisticated sick population who don't even know what their rights are in case of pain and suffering and who are probably told that they are being done a favor. Because they are so poor and have no access to ANY drug in the first place, they probably believe that. Do you seriously expect that allowing self regulation in backward rural India, with substantial financial perks for doctors conducting the trial, the system is not wide open to abuse? Removing the requirement of Phase I and II trials from the countries of the drugs' origin is a huge mistake. It removes the onus of due diligence and liability from the companies and opens the door for cooking data, lax experimental conditions and massive cover ups in case of a disaster. Even if the test subjects are grievously harmed, what will be their recourse? The Indian government has probably removed their ability to sue the drug companies by transferring all responsibility of safety to India.(Again, I need to check with the lawyers). And unless some activists take up the case on their behalf, they will just suffer and die quietly. Their survivors and families will be given a pittance to shut up and not complain. Remember Union Carbide and Bhopal? Except this time around, the government of India will be complicit to a possible human tragedy that may ensue from a dangerous drug trial.

And all this has nothing to do with the IT miracle or the 8% growth index -please do not correlate the two.

[Sanjay]

Ruchira,

For the longest time, numerous indian pharma companies simply "re-engineered" drugs which were tested & approved elsewhere without the need to do any testing on indian subjects, under indian conditions. Effectively, this meant that foreigners were the "guinea pigs" for many drugs that Indians were using.

Today, the indian medical infrastructure is greatly improved; there are increasing number of English speaking, ICH –GCP aware research investigators, improved human subject protection, greater government committment etc. All this has led to increased international acceptability of Indian data & this confidence is relected also in the fact that the highest number of FDA-approved facilities outside of the U.S. are located in India.

Having said this, I fully agree with the implementation, "street level" issues you raise. This chicken & egg conundrum always occurs when one does something for the first time with no prior track record. It remains to be seen how all this will play out in real life.

Sanjay

[Ruchira Paul]

Sanjay:

I hope you are right that stricter standards are in place in India now. I hope the drug trials will not callously exploit a vulnerable section of society for profit and dubious medical progress. But when I hear about the poor being targeted for organ harvesting or surrogate motherhood for money and Indian doctors routinely flouting anti gender testing and female feticide laws, I am not as optimistic as you are.

The street level implementation is precisely what I am concerned with - not what the government puts in its compliance papers. Let us wait and see. Hopefully, everything will go by the book. India's progress ought to rely on its genuine talents not by a soul-less focus on the bottom line. Thanks for your informative input.

[Sanjay]

Ruchira,

In Boston, clinical trial companies routinely place recruitment ads inside public transit trains & buses. By contrast, I have never seen these ads in the Wall Street Journal or The Economist. If so inclined, one could reasonably make the case that the inner city poor/ young/ uneducated are being targeted.

Wrt to the links you provided on organ harvesting & surrogate motherhood, I see a demand-supply driven market behaviour. It may be seamy (comparable perhaps to some western women renting out body parts on ebay) but there is nothing to indicate coercion.

As far as "female feticide" is concerned, the issue is much too complex to even barely scratch the surface in a 300 word article. Even the link with dowry is very tenuous, as can be shown from the sex ratio United Nations datapoints of several nations where dowry is NOT a custom:

United Arab Emirates - 195
Bahrain - 135
Saudi Arabia - 115
Oman - 113
Samoa - 111
Papua New Guinea - 109
Jordan - 108
Libyan - 108
Afghanistan - 107
Bangladesh - 106
China - 106
India - 106

As an aside, there are more than a dozen Eastern European nations whose sex ratio is skewed heavily the other way i.e way too many women to men.

Would you recomend that clinical trials not be allowed to take place in these countries until their sex ratios were back in line with western ratios?

I guess I'm a bit confused by this linkage.

[Ruchira Paul]

Sanjay:

This is going to be my last comment on this issue. I cannot explain my point of view any more clearly than this.

You can keep throwing numbers at me and try to refute my arguments to fit those numbers to make your point. It's not going to help. We have a clash of philosophies here.

You and I are coming from entirely different sets of convictions. You worship at the altar of "unbridled free market" and "supply and demand". While I have no great quarrel with most reasonable effects of market forces, I don't believe that the "invisible hand" is that invisible. I do believe that it is hypocritical and a bit heartless to cry "free market" in a world where economic fortunes are so disparate. Take inheritance for example - wealth acquired without lifting a finger. Can you think of a bigger refutation of the free market ? Yet those born with silver spoons in their mouths, scream the loudest about free market and "opportunity" making it a level playing field for all. I do not advocate an intrusive nanny society or a utopian concept of perfect "equality". I have great respect for individual excellence and innovation being rewarded. But at some levels where gross exploitation is a possibility, the "human hand" needs to set matters right from time to time for the sake of common decency.

Taking things one at a time:

You keep putting words in my mouth. Where and when did I argue that gender ratios "have to be in line with western numbers" before clinical trials are allowed in a country? I am taking issue with the gross transgressions by physicians and medical personnel in India who are going against the country's laws in facilitating female feticide. If more boys are born "naturally", and the boy to girl ratio ends up being as high as some of the middle eastern nations, I have no problem at all. By the way, are those numbers in the Arab countries so high due to female feticide too? If they are and it is not for dowry, could it be that women in some of those societies are so oppressed under male tyranny and female life is so devalued that mothers do not want to have daughters? Again, let me make it clear. My problem is NOT the ratio but the corruption of the doctors who are indulging in an illegal act for money. Hence the suspicion about their role in the implementation of safety laws during drug trials.

I have no doubt that drug trials here too target the poor. But the level of dissemination of information as well as the available avenues for redress in case of injury (via the courts) are greater in countries like the US. I already made this point. The poor will always take more deadly risks for money than the rich - is that so hard to understand? That is why monetary incentives for organ donation are banned in most countries because that will instantly create a market of poor donors and rich recipients, at great health risks to the poor. If I follow your argument of market forces being infallible, what is wrong then with child labor? Many families in India will benefit (and indeed they do) if the seven, nine or eleven year olds in those families work in farms, shops, factories or private homes and bring in extra income, instead of going to school. There is enough supply & demand in India (and elsewhere) for that kind of cheap and easy to control labor force. Do you support that? If not why not?

You may have no problem with market forces dictating the use of the bodies or body parts of the poor to benefit the rich. But I do. That is why I also do not buy into the much vaunted "volunteer" nature of the armed forces that are fighting Bush's unjust war. I am for the draft where the burden of "defending" the country will fall on all sections of society as it does in Israel's compulsory military service. Why do mostly underprivileged young men and women sign up to risk their lives and limbs on the battlefield? Is it because they are more patriotic or are they more stupid? We may shout from the rooftops about free will, informed choice and lack of coercion. But Sanjay, you know what? Economic hardship is the biggest coercive force of all.

[Sanjay]

Ruchira,

I do have a takeway from this discussion i.e the relative ease with which medical professionals in india can bypass the best-intentioned laws in india. Therefore, your concern about the rights of the weaker segments of society being flouted without legal recourse, is certainly valid. I have no 100% satisfactory answer to this concern other than to accept it as a valid issue & suggest "lets wait & see what happens". Otherwise, quite frankly, I'm not sure how to respond to you since this appears to be more about you, me, our philosophies etc & not about the issues at hand.

I do agree with you that when we take an empirical fact (i.e. no difference of opinion there) like sex selective abortions in india & postulate different explanations, then we do indeed have a philosophical difference. I guess we have two choices:

(1) your interpretation is correct & mine is incorrect. It is one or the other, never both
(2) both interpretations are valid; combined, both are closer to the truth than each is alone.

Indian philosophy (& I would too) would subscribe to #2. However, #2 is painful. It means I have to listen to, understand & re-state your position so well that you would be forced to admit that I undertood your position as well as you did yourself. And, vice versa.

My apologies for waxing philosophical :-)

[Ruchira Paul]

No apologies required. (I guess my last comment was my second to last!)

There indeed is a difference between our outlooks. Therefore, "let's wait & see what happens" may be the only sane solution here. I hope in this case, your optimism triumphs over my skepticism. I am also hoping that somebody will be keeping their eyes peeled and ears open when these drug trials go into effect.