Wired says a real-life Constant Gardener scenario has just begun playing out in India. New rules against generic knockoffs of Western drugs have emboldened pharmaceutical companies to use India’s poor as cheap drug testing guinea pigs (via Slashdot):
… multinational corporations are riding high on the trend toward globalization by taking advantage of India’s educated work force and deep poverty to turn South Asia into the world’s largest clinical-testing petri dish… trials account for more than 40 percent of drug-development costs. The study also found that performing the studies in India can bring the price down by about 60 percent…
… in March, everything changed when India submitted to pressure from the World Trade Organization to stop the practice and implement rules that prohibit local companies from creating generic versions of patented drugs…. the number of studies conducted by multinational drug companies has sharply increased since March. [Link]
There are attractions other than low cost:
“Doctors are easier to recruit for trials because they don’t have to go through the same ethics procedures as their Western colleagues,” Ecks said. “And patients ask fewer questions about what is going on… ” Companies are attracted to India not only because of the huge patient pool and skilled workers, but also because many potential study volunteers are “treatment naïve,” meaning they have not been exposed to the wide array of biomedical drugs that most Western patients have… [Link]
Ethical shenanigans aren’t restricted to just Western pharmas:
In 2004, two India-based pharmaceutical companies, Shantha Biotech in Hyderabad and Biocon in Bangalore, came under scrutiny for conducting illegal clinical trials that led to eight deaths. Shantha Biotech failed to obtain proper consent from patients while testing a drug meant to treat heart attacks. Biocon tested a genetically modified form of insulin without the proper approval from the Drug Controller General of India or the Genetic Engineering Approval Committee. [Link]
The saddest thing is that if the drugs work, the testers are unlikely to even have access to the drugs:
Since many pharmaceutical companies are developing the drugs for markets in industrialized nations, it is unlikely that India’s poor will have access to most of the new medicine. [Link]
I knew I came across this awhile back.. Virginia Postrel wrote thusly about it –
Laziest comment ever.
Story is about March 2005. Your link is November 2004.
No clash. I grant pharma is good. That’s orthogonal to empirically abusive clinical trials.
Irrelevant. Postrel is worried that Westerners will be demonized. Post is about all pharma including Indian.
Shorter V: “Oh, this post must be ‘against’ pharma, so let me post something random ‘for’ pharma.” That’s football hooligan thinking.
I must have brain freeze, because I have no idea how these two things connect:
The new rules against generic knockoffs mean that Indian companies, which used to be strict manufacturing sites, now either must wait for patent expiry, obtain a license from the pharma company, or develop a new drug with new clinical trials. But I don’t see how the new rules lead to pharma companies thinking India’s poor are great candidates for clinical trials.
The link Manish cited:
Also makes no sense to me. If Indian subjects are so different in terms of exposure to drugs, it’s highly unlikely those subjects would be allowed to support a regulatory approval in the US or EU. Similarly, any study that is multi-national would require a similar standard of patients in every nation’s trials. Unless these drugs are being developed strictly for the Indian population alone, I would guess the advantages of running most trials in India are highly overblown.
What this means is that the real value of using India for clinical trials is probably in the Phase I setting. At this point, the potential drugs have not been tested in humans, and have some of the highest failure rates (due to bad side effects, toxicity, poor human exposure). This is where the ethical quandary enters, IMHO. You’re talking about a bunch of healthy volunteers that are bearing risk without any real chance of benefit. Furthermore, it is highly unlikely that they would have access to the drugs that are developed, and even if they did, it would be 5-6 years out in the future, at the earliest.
For a while, Europe was considered a great place to run Phase I trials, because the regulations were more lax, and pharma companies could get studies up and running more quickly there as a result. However, the inevitable pendulum swings, and regulations are now in place in the EU that are just about as stringent as the US. One would hope that India would put similar regulations in place, if this really starts to happen on a large scale.
Or maybe I just need this explained to me like I’m a three-year old. 🙂 Sorry, Denzel got the best of me.
manish – pls try & be a little more respectful of my intelligence (even if you disagree with it…)
Your article is about testing in Mar ’05. Mine’s about a prediction in Nov ’04 that such testing would lead to denunciation.
Postrel was right.
sheesh.
Some (probably all?) biotech / pharma companies freely make their candidate drug available to the patient for as long as the patient is alive (i.e. even after the drug has been approved). True, the drug won’t be available to everyone in that same country who didn’t participate in the clinical trial, but at least the people who participated in the trial are assured a free supply. Just wanted to clear that up…
Manish, I don’t understand you comment:
A pharma company designs the protocols used in the clinical trials, or if outsourced to a CRO, is aware of the protocol used. I can’t follow how you grant that pharma is good, and then condemn what you think are empirically abusive clinical trials.
Okay, “I don’t understand you comment” should be “I don’t understand your comment”. How ironic.
I did use the preview button. Sepia Mutiny would be even more awesome if we could edit our comments after posting them 🙂
sorry ladies and gentlemen for being such a pain. manish :::i am again posting a query, which i had posted, late on the secular right debate [slugfest], pre weekend. but seems, you guys overlooked. so here goes again. as you may have noticed, brevity is not one of my talents.
manish et al: i missed most of the debate. however did just glance through the posts and noticed something you posted, which may help get my point across. i wil confess beforehand that i do not know the context of this particular post, and i do not think it is relevant to my point either. hope you understand. manish – “A very Om-ly Christmas, Krishna for Christmas, Happy Diwahanukwanzidmas”
i would love to see the reaction of the “south asian” community, if they, the sepia mutiny people, simply for the heck of it sub, prophet muhhamad for krishna. i.e muhhamad for christmas, etc or muhhamad loves diwali or muhhamad for hannukah etc, you get my drift.
my suggestion may seem a bit churlish – and i agree. but given the futility of the merry go round here, i think this is a great way to put your sepia mutiny money, where your mouth is.
and in all honesty, i think you guys as well as us guys understand exactly wht i am getting at.
bestest, manav
brimful, i might not be getting it either, but what i gather is that now since india can’t manufacture generics on its own, all the indians that need drugs will rely on western pharma — so they’ll be the test subjects and a good chunk of real subjects.
wto = evil. >:\
runnerwallah:
This is actually not true, in my experience. There are rare cases that companies have clinical trials that are long-running, and as such, allow patients to continue on study drug, but this is not true for most clinical trials. And even then, that’s a tiny percentage of the patient population that would actually benefit from access to these high-priced drugs.
Leena, I still don’t get the connection, especially since the generics’ rules will still allow Indian companies to manufacture drugs at lower prices, just not as low as previously allowed. But I appreciate the effort!
brimful, You are right – I was wrong to say “all” when I wrote my comment. However, in my experience, I do not think this practice is at all rare for companies producing cancer or AIDS-fighting drugs. I grant you that the clinical trials happening in India encompass much more than cancer and AIDS-related drugs.
And I grant you that there are cases in AIDS- and cancer-related drugs (I’d even say much more often with AIDS than cancer) that patients are continued on drug– however, these are only in late stage (Phase II-III) trials. In early trials, especially Phase I, which is more likely to be the real draw to markets like India, subjects are taken off trial regardless of what type of illness is under investigation. This is usually because there is no evidence of efficacy and no definitive proof of safety in Phase I.
It’s sad and pathetic that the WTO is controlled by American Big Pharma and that Indian drug firms caved to their pressure. The generics that India develops for AIDS is the only viable solution to the epidemic in Africa and Asia. Meanwhile, American pharmas continue to gauge 3rd world countries, NGOs and other aid organizations who cannot possibly afford their inflated prices to provide the AIDS cocktail to the most seriously afflicted areas of the world.
A single pill Indian generic version of the cocktail would save literally millions of lives but the WTO apparantly is more concerned with protected the patent rights of the most profitable coporations in the world. But hell it wouldn’t be the good ol WTO if they weren’t looking out for the wealthiest people in the world at the expense of the poorest. Now that Wolfie’s in charge I expect them to really start working over the hungry and diseased.