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Subscribe to RSSDateline NBC's Chris Hansen reports from India, where drugmakers are increasingly going to do the human testing needed to bring their drugs to market. Watch this full 'Hansen Files' report on Sunday, March 4th, at 7pm/6c.
Few people in the slums of Ahmedabad, India, know more about the supply of human guinea pigs for clinical drug trials than Rajesh Nadia.
When Indian firms working for pharmaceutical companies need test subjects, they often turn to Nadia, who has carved a small niche for himself as a recruiter in the international drug-testing industry.
“Companies call me or send me text messages,” he told “Dateline NBC” correspondent Chris Hansen.
Self-confident and well-groomed with gelled hair and tight-fitting designer jeans, Nadia said he is paid about $12 for every recruit he brings to the three Indian research labs with whom he works. In a region of western Indian where the average worker earns 50 cents a day, that’s good money.
“I don't feel guilty,” Nadia said. “I believe conducting these studies is a humanitarian effort. So many people benefit from (the) advancement of medicine.”
Drug trial outsourcing to foreign countries is rapidly becoming an attractive alternative for U.S. pharmaceutical companies looking to save millions of dollars, avoid regulatory scrutiny and tap into a seemingly endless supply of drug study participants.
But a year-long Dateline investigation into one of the preferred destinations for overseas drug trials, India, raises questions about lax regulatory oversight in these studies, the integrity of some of the companies contracted to run them and the reliability of the data they produce.
Whether the studies are for birth control, diabetes, migraines or high blood pressure, money often draws volunteers into Indian drug trials. And Nadia said that many of his desperately poor recruits are so eager to enroll that they disregard potential risks.
“They don't regard the smaller side effects,” Nadia explained. “Sometimes, people feel weak or get body ache. They don't care about these little things because they need the money.”
David Lom / NBC News
When Indian firms working for pharmaceutical companies need test subjects, they often turn to Rajesh Nadia, who has carved a small niche for himself as a recruiter in the international drug-testing industry.
Dr. Chandra Gulhati, editor of the “Monthly Index of Medical Specialties,” an Indian medical journal, points out that luring test subjects with money violates India’s Drugs and Cosmetics Act. The act allows some payment, but not enough to sway free will.
“It should never be so much that it works as an inducement,” Gulhati said.
In practice, however, the pay is often just that. Subjects can make up to $400, depending on the length of the study -- far outstripping traditional earnings.
The financial incentives can lead to study volunteers enrolling in more than one study at a time. That not only puts their lives in danger, but it also can skew the accuracy of test results that drug companies and regulators rely on to judge a drug’s safety.
Asked if he was aware of volunteers taking part in more than one study at a time or ignoring “wash-out” rules designed to allow their bodies to be clean of test drugs, Nadia didn’t hesitate. “It happens. Lots of people do that.”
“Sometimes the subjects have to log into the system through thumbprint readers and sometimes they get caught,” he said. “But if (the companies) need the subjects desperately, they will ignore these things.”
'People keep falling sick'
Parsottam Parmar is a social worker in Ahmedabad’s slums who advocates for higher wages and ongoing health care for drug-study participants. He is alarmed by what he is witnessing.
“People keep falling sick,” he said. “There are many instances where there are swellings in the limbs, loss of eyesight. Several deaths have occurred … It becomes a question of human rights -- a big one at that.”
View from a hidden camera shows volunteers for a clinical drug trial in a waiting room of one of the companies that conducts the studies.
The Indian government reports that across the country more than 1,500 people have died in clinical trials since 2008, many participating in studies for Western pharmaceutical companies. Because official documentation of the deaths is frequently incomplete or non-existent, it is unclear how many people died from the same illnesses that initially qualified them for certain drug studies.
Gulhati, the editor of the Indian medical journal, said official inquiries into drug-trial deaths are rare.
“Unlike the Western countries where there is an audit of each death during [a] clinical trial, we don't have a system like that at all,” he said. “So that is the biggest problem.”
The lack of oversight by Indian government officials, Gulhati added, has created a culture of impunity for drug research companies and the doctors who work for them.
He offered a recent example. In 2010, an Indian government investigation confirmed 10 deaths at drug trials sponsored by Western drug companies, including Pfizer and Astra Zeneca, at the Bhopal Memorial Hospital and Research Centre. The facility was built to treat survivors of the 1984 Bhopal gas disaster.
Gas survivor patients and their families said some of the doctors who enrolled them never informed the patients that they were in drug studies nor did they pay them the requisite compensation. The hospital was paid more than $200,000 to conduct the studies, according to government records.
Gas survivor advocates also claimed that at least one of the 13 studies conducted between 2004 and 2008 appeared to be illegal in India at the time.
The Indian government later cited repeated violations of guidelines and regulations during those trials conducted between 2004 and 2008, but no penalties were issued to the hospital, doctors or study sponsors.
In a warning letter to one company, India’s Drugs Controller General Dr. Surinder Singh wrote, “…you are hereby warned to be careful while conducting clinical trials to ensure that such deficiencies/discrepancies are not repeated in the future.”
The companies sponsoring the studies said that international standards and Indian laws were followed, though Astra Zeneca acknowledged errors in receiving proper consent from some patients. It said the problem was “promptly corrected.”
FDA faces 'handicaps' overseeing foreign trials
Although data from overseas studies is used to help win FDA approval for drugs, the agency told Dateline in a statement that it faces “a number of handicaps in its inspections of foreign clinical sites, which are not technically under FDA jurisdiction under international law.”
In India, for example, the FDA said its inspectors are not legally permitted access to confidential records held by contract research firms that often do testing for Western pharmaceutical companies. It’s a law that would severely hamper any investigation into a patient’s death.
Satinath Sarangi, director of the Bhopal Group for Information and Action, told Dateline that the incentive for drug companies to conduct research in India is obvious.
“You can do it cheaply, do it with no regulation, and even if there are violations, get away with it,” he said.
Following reports of unauthorized drug studies on children and mentally disabled patients, India’s health minister, Ghulam Nabi Azad, told reporters last month that some companies running drug trials in India are not following regulations.
“Sometimes the companies don’t go by the laid-down procedures and it causes great harm to persons and individuals on which this test is carried out,” he said.
Even when deaths during drug trials raise questions, drug companies can eliminate those questions at little expense.
Last year, Azad, the Indian health minister, confirmed that 10 foreign drug companies paid an average of about $4,800 to relatives of 22 people who died during or after participating in drug trials in 2010. The amount is a small fraction of compensation paid for similar deaths in other countries, Gulhati said.
In the meantime, reports of illnesses and deaths linked to drug trials are doing little to deter a steady stream of willing volunteers. And Nadia sees no risk to his franchise.
“There is more supply than demand,” he said. “There's nothing to feel bad (about). The subjects need the money, so they go. It's as simple as that.”
Tim Sandler is a producer for "Dateline NBC."
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What a sick B-Tard. Selling his own people out.
For every seller there is a buyer. At least the Indians are getting paid and being told they are test subjects ..... unlike some unsuspecting prisoners or welfare moms.
Aren't Indians supposed to be fellow human beings to these people that run run these ruthless drug companies?
WAY TOO MANY people making WAY too much money off the sick, that is why our health care costs in the US are so RIDICULOUSLY HIGH. INsurance companies, for-profit networks, medical equipment, drugs, they only care about their stock price.
We need to thunderstomp the paid for in full by the rich party out of DC in NOV. and implement good healthcare.
And we Americans are more than willing to use our Vets by way of the VA and Universities for "bodies" to work on...the Walking Dead!
Prime example of what happens without effective government regulation and oversight. People can blame big, bad pharma all they want, but ultimately it's the responsibility of the Indian government to protect its people from this type of predatory business practice in the form of meaningful legislation and regulation. For-profit enterprises will exploit any and all angles legally and practically available to them.
Money - we created this and we will live by it and die by it. There are millions of examples in all directions where money compromises our humanity - this is just one example. Count your blessings if you don't have to experience this or any other means of prostitution to obtain money. For those who are not blessed may we change for the better such that nobody's dignity is compromised.
Have a great day people and smile :)
This Is nothing but MSNBC's (Obama's Propaganda New Station) attempt to divide and create contempt between the have and havenots in this world.
Anyone, I mean anyone can go to any teaching university in this country and sign up to be a candidate and participate in new drug clinical trials and get paid for it too!. In fact the US GOVERNMENT does this as well, just call the NIH.
Thank you MSNBC for the continued fermentation of Obama's re-election campaign - Class Warfare. The more people Obama has living off the government tit and hating his fellow American for having more, the more votes he thinks he will receive.
Obama - The Great Divider - Disgusting!
Oh puh-leeze. Like the US is so ethical and innocent. You do know that the military sprayed pneumonia pathogens over the city of San Francisco after WWII to simulate a biological warfare attack and its effects, right?
I say they all be granted Amnesty (sponsored) by these American drug companies. In addition they should be given immediate American citizenship.
Just a thought.
And now we know why there are so many drug recalls in the US lately. Drug gets FDA approval based off of unethical trials with no oversight. Then when it hits the shelves here and people start having reactions the FDA wonders why?
No, thanks. I'd prefer if they just kept sending their intelligent, educated ones here.
hahaha it seems the majority on here don't realize we in America are being made to ingest experimental drugs everyday and we not only don't get paid to do it but WE are PAYING the government for it!! It's in most of our food supply people. Wake up America!
I know, it's F-ing terrible. I mean, look at how our life expectancy keeps increasing every decade. How awful. Something should be done about this.
You conspiracy nuts amuse me to no end.
PDK - better start paying attention to newspaper and TV ads in the US.Medical reserchers are always looking for test subjects meeting certain criteria. They pay for the tests, meds and transportation costs. Wouldn't be surprised that they are payed for their time as well.
Rats, mice, monkeys and rabbits only go so far.
Think of all the medical campus studies carried out on students who want to earne a little extra.
Beats using monkeys.
(Comment only designed to spark conversation, don't get mad, it's not a serious comment)
purbopathik -Please review the caste system in india. It may be illegal to practise it, but that doesn't mean it doesn't happen.
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Respectfully, american, I wasn't aware I had written anything in my previous post implying that I do not pay attention to newspaper and TV ads here in the US. I'm well aware of the fact that human clinical trials are conducted in the US, and that most, if not all, of those studies include some form or compensation or other to participants.
The difference is that clinical trials conducted by US-based research organizations on US-based subjects in the US are subject to far more scrutiny from the FDA than similar studies overseen by the equivalent regulatory agency in India. Moreover, compensation to Indian test subjects can form the basis of their entire income, while compensation to US test subjects is typically in the form of free medical care in the course of the study and/or relatively small monetary sums.
Other than it is unsafe and inhumane to Indians (howsoever poor they are) it is also equally dangerous for Americans since we do not know the true safety and efficacy of these drugs because the sample population used in India may not be very well controlled due to poor regulations.
I think enforcing better standards across borders will result in economic benefit for Indians and better guarantee of safety and efficacy of drugs for Americans.
Chris Hansen got promoted from reading steamy messages of middle aged perverts.
This article only shows the negative side of the testing experience in India.
To all those incited by this skewed article as well as the original poster, it's amazing how much of a mindless zombie the media has turned you into without considering all the angles & perspectives on this issue. I will make it short, but you should do your own research --- This is incentivized testing that is completely voluntary, and also a luxury if you also consider what we are barred from in the states. My aunt had a very serious condition, did her research, and contacted the pharmaceutical companies here to gain acceptance to a test trial that would have possibly given a longer chance to live, only to find out that the red tape held her life at bay until the drug was properly ready to market. It's a two sided sword, but we as humans if given a chance, should be able to be given the chance to participate, as our life depends on it at times. The only thing I see this guy as is an embellishing informant. It's up to the rest of the participants to be informed, as without them, there would be not be advancement on R&D, and the drugs you or someone you takes would not even make it in our market. There's always 2 side to a story!
That guys a major "indian giver"
In a region of western Indian where the average worker earns 50 cents a day, that’s good money.
Nobody here can say that there are not guilty of sin. We all have benefited from drug companies, and they stopped using animals because people were protesting about that.
So, Who is going to try those drugs? only terminally ill people, or people that do not have a chance to do anything else in life due to poverty. So, this article is probably launch an investigation, sue some pharmaceutical companies, and some people will be just as poor as they were before. That will be the end to that.
I am not passing judgement. I would just be very careful to point fingers. The next time that you need a medicine for a bad disease, or cancer, you just may want to say a prayer for the poor fellow that sold his body, so you could keep yours.
If the FDA doesn't have jurisdiction over the criteria and then the subsequent product that arises out of it, then the FDA doesn't have jurisdiction to "allow" any product use outside of its jurisdiction under FDA Licensing to the Drug Companies. period But, they more than obviously have all the jurisdiction needed to "disallow" licensed development, distribution to consumers and "legal" use by consumers.period, again.
Hmm... Sound like anyone's political agenda here much?
Tired; That happens everywhere-especially in Religion and Politics.
Denver; Don't forget the military are directed test subjects, as well.
Purbo; you answered your own question. At best, they're a faceless number or statistic.
What I don't like about the drug companies is they charges the Americans almost 3 times what other countries pay for the same medicine. We had a Canadian engineer that worked with us. He would get his parents to get his medicine for him. He took some kind of migraine headache medicine in Canada it was around $45 in the US it was $130 something. Before they outlawed getting meds from Canadian Pharmacies my wife could get a 3 month supply for what 1 month cost here. Same medicine made by the same company.
Watch those microscopic disclaimers on TV ads again. More often than not, the drugs advertised do not even have FDA approval. But that's OK I guess...those poor pharmaceutical companies need the money so bad, they can't wait for a silly little thing like testing or approval.
Finally, we found a use for the third world.
I agree, this is all Obama's fault.
"Few people in the slums of Ahmedabad, India, know more about the supply of human guinea pigs for clinical drug trials than Rajesh Nadia."
I watched the entire show last night... sigh
i find study programs helpful for my ailments..otherwise, i could NOT Afford Medical Care..its Not about the Money for me, although its helpful..i am deeply appreciative for the medical care given..that is the most important thing right now in my Life..so far, so good, i don't expect freebies, however i cannot afford Standard Medical Care in My Life..i know, get a job, U have NOT walked in my shoes or been in my path of LIFE..i seek NO SYMPATHY or empathy..i refuse to be mundane as most, i Live a very humble Life..
Can't you just heal yourself with all your jesus-powers
Puhlease! Jebus couldn't find its own arse via both hands, a flash light, and a map.
Its been 2 millennia plus and it still has holes in hands and feet. Its still missing although the picture on milk cartons has been widely distributed for many decades.
IDIOTS!!!!
Where is WHO? They can test drugs in India as long as they are transparent and testees are given pre and post assessments (all tests). Most Indians are vegetarians to start with and their metabolism- let alone infectious diseases - have had- and then some of the people like Tamils (later British Tea company transferred them to Ceylon=Sri Lanka) have an inborn deficiency in their eyesight. Is that taken into consideration? In US of A the drugtests lured a lot out and down people with alcoholism- they got care/hospital stay/money- to buy a jalopy to live in- but they got heathcare and nutrition and compensation for being testees- perhaps the drug companies never considered their alcoholism metabolism and that's why some of the cardiac drugs had to be pulled out of circulation. FDA is not toothless- it can demand transparent drug trials etc before issuing a permit- license. FDA has also been very lax when it comes to fake= counterfeit drugs.
I was thinking why the hell would we out source testing our medicine?!?! OMG I had to of read wrong. I mean they make it sound as if they cheat to make more money that could end up real bad!! for PPl in other countries taking drugs from unreliable data...
"Testees" lol.
You mean "subjects", right?
Kjosee...trials are outsourced because many americans are well aware of the potential side effects and wouldn't submit to experimentation. In the US mostly white males sign up for these trials which inherently skews the data.
Providing drugs to help humanity... but at what cost TO humanity? These poor people. :(
They know they're taking a risk. Their being recruited, not coerced. Think about it this way: they get paid 50 cents a day on average. Let's say they get offered a hundred bucks to participate in the study. You say, "hell no! That's not enough to risk my life."
Now take this into consideration: that's forty times their weekly pay. The median American income in the ballpark of $1000 a week (before taxes). So would you participate in a drug trial for forty thousand bucks? I bet you're at least considering it now.
Sara in Texas, I am sorry to break this to you but we are being poisoned everyday here in America by big government putting experimantal chemicals into our food supply and we don't even get paid for it...
such as...?
give evidence please, not just babbling nonsense
Chris, what if these paid victims choose to make good reports and not report side effects? That money really can go a long way to helping their families and I'm sure they don't want to get fired! You think lots of money making people think of only their own self-interests can only be a good thing in a drug testing? This works in favor of drug companies to get their FDA approval based on test trials that don't truly report the side effects.
India has many gods. It seems that chief among them is chief among ours: Lord Profit. It seems also that the preferred sacrifice is the same, i.e. the poor.
And that one with all the arms.
FDA could easily stop this. Simply say that results of testing done outside of the US are inadmissible for determining US status.
I'd also be willing to speculate that their poor and subsequent less sanitized environment would provide them with stronger immune systems. Thus enabling them to fight off infection side effects better than say a 50 yr old cancer patient. That would kinda make for a shaky side effect foundation.
Dan-
then they would have their excuse for drug prices to skyrocket
except they Dr.s sitting on the FDA have financial ties to the pharmacuetical industry...they are profiting...blood money, very, very sick indeed.
THIS IS GLOBALIZATION ! Move jobs from the West, including Europe, Pay crappy wages with no benfits to poor people, take advantage of them and sell at high prices to Americans and Euros.
Brings ALL people's standard of living down except the rich and very poor down.
THIS.. IS... BOLD FONT.
So who's the worst human trafficker? This guy, or a pimp trying to make a honest living?
All the drug companies tout "transparency". This hardly factors in when they don't think they will get caught. Their philosophy is money first, people second. I highly doubt these poor people in India realize the consequences of these trials. And when all goes wrong, who is there to support and care for these individuals? No one. That's why they go to poor countries. They couldn't get away with it so cheaply here in the US. Easy prey, easy pay.
I wish only people who had a clue would be able to post here.
Working for a drug company, I know for a fact that companies would much prefer to enroll at all US sites. Much less risk even if it costs more. We are well off in this country and recruiting volunteers is difficult. The only reason that Pharma goes elsewhere is because of ability to recruit faster than a snail's pace. Any little issue in clinical data can add years to the time it takes to get approval. Definitely not worth saving money to go to a country like india.
Life is unfair. The poor always suffers. Drug trials should be using the sicks, not the healthy and makes them sick.
No, initial trials must use healthy volunteers first. Once a drug is found to be safe in healthy volunteers, only then is is allowed to be studied in the sick. Lot's of ethical reasons why it should remain this way.
We have more and more compounds entering into the market place that need to be tested. And what drives this testing is the patents the drug companies obtain on them. Many drugs developed for one reason prove to be ineffectual so testing in other areas of "use" are done to help offset R&D costs. The FDA is underfunded as drug companies push to have drugs that are effective --whose patents have expired--OFF THE MARKET and replaced with patented drugs. Doctors are allowed to invest in drug companies thus making them sales persons for new and experimental drugs. The system is convoluted and corrupt at a high human cost. Vote for the public option in health care and get rid of "conflict of intrest" NOW.
Doesn't that Indian guy despairing over the number of ill in his neighborhood realize that only half the subjects in these drug studies are getting any medicine at all while the others are getting inert placebos? One of the reasons the companies have trouble getting participants here is that too many people know how they work.
I see nothing wrong with these career subjects doing multiple trials. Since double blind trials violate medical ethics anyway, the subjects might as well be partners in for-profit medicine. Anyways, all that matters to the company is that it turns out positive statistics- the bottom line is how much income the new drug generates. Whether or not it works well is of secondary interest.
Well, I guess the upshot is they're at least getting paid.
I would be good with testing the POTUS first. Especially the one currently in office.
Troll alert.
LOL
another butt-hurt teab@gger troll !!
They should be testing on Death Row Inmates, no innocent poor people.
India is an overcrowded outhouse from what I've seen, they have an excessive amount of people for such a small country. I say let them do it, they have plenty of people to spare.
Um, this seems to be a pretty stupid idea. God knows what kind of people are volunteering or submitting to these trials. I can't imagine the average street laborer or factory worker in India has a well-documented medical history, something that is pretty critical for obtaining reliable results from drug trials. In addition to allergies, it's imperative that other vital functions of test subjects are documented and understood. A antidepressant could have very different side effects on someone with bad liver function as opposed to someone with good liver function. I'm sure they do a battery of tests to at least establish a semblance of a control group before beginning testing, but I can't imagine they'd have access to the same detailed medical histories they would get from US participants. So, as usual, outsourcing will have the effect of shoddier products.
outrageous!
Rajesh is what they call a community advocate. Research organizations recruit these individuals so that these trials will be readily accepted into the communities. Without people like him, communities may perceive that they're being experimented on...given US history. There is absolutely nothing illegal about it because every one is given an informed consent. The question is...do they understand what taking experimental drugs really means. Most informed consents don't include side effects because as an experimental drug...they don't know what they are.
Zombies : /
And on another note, it happens in Thailand (commercial sex workers), China (intravenous drug users), parts of Africa (people living with HIV/AIDS)
I don't think Dr. Joseph Mengele works for any of these pharmaceutical companies. They are not trying to harm people. They would have already done lab studies that show promise for these drugs.
I would think for the companies to measure results, the volunteers would have to currently suffer from whatever condition it is that they are hoping to treat. Therefore, if the drug is successful, they are able to receive treatment at no cost. If there are unfortunate side effects, better to find them in someone who volunteers knowing the risks.
Yes, I feel sorry for these people that they are so poor that they resort to this but who else would be in line for studies? Shall we go back to testing people in mental hospitals?
Laura even for the drugs that are tested and make it to market. How many in recent years have been recalled or production has ceased because they later found out it caused an ailment it wasn't INTENDED to? If you wanna test drugs, test on KNOWING participants. If you have to teach a person about the concept of time (as far as a clock is concerned) so they know when to take the medication...that is no longer informed consent. Is it INFORMED consent if you use a poor population that's more concerned with the compensation than the potential side effects? Or is it taking advantage?
Canopy Jones,
When we get down to brass tacks, people hired for most tasks are the ones that are willing to take the least amount of money and/or benefits. I'm not speaking of highly technical positions but the grunt work that the majority of people do.
Canopy,
Unfortunately there have been a lot of approved drugs causing serious side effects.
The thing is that frequently the drugs also provide patients with positive effects. Some people have had their lives hugely improved and extended by drugs which later cause them problems and then the attorneys jump all over it with big class-action suits. You see these all the time in commercials. The improvements should also be taken into consideration. All these lawsuits only serve to increase the costs for everyone and increase these drug trials.
I believe that if I were told I had a terminal illness and then given a drug that gave me another five years but after the five years I would have side effects; I would be glad to get it.
This is heartbreaking.
No, it's not. Mildly upsetting or discomforting, maybe. "Heartbreaking" is when your wife has an affair or your dog gets run over in front of you. Some poor people making a buck half a world away by putting their health at risk is pretty ho-hum, when you think about it. They're still probably in less danger than, say, Chinese coal miners, you know?
"India’s health minister, Ghulam Nabi Azad, told reporters last month that some companies running drug trials in India are not following regulations. . .. ... .."
What is that? a minister or an idiot? since you know of such illegal activities, then do something to fix it moron
Ha. Like his pockets aren't lined with pharm companies' cash.
Another nasty side affect of the negative system called INSURANCE Industry!!!! where the medical INDUStRY is no longer motivated by ALTRUISTIC energies - BUT GREED!!!
It's been this way for 500 years and isn't going to change anytime soon.
How long before we have this very thing in the US,with so many very rich and more and more people poor and less middle class.
Only way to answer that is vote republican and sit back and watch.
I wouldn't bet the farm that this ISN'T also taking place in America.