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Subscribe to RSSGUJARAT, India – Rambha Gajre was desperate. She and her family faced eviction from their cramped, tin-roof hut if she didn’t soon repay loans she used to cover life-saving medical treatment for her son.
David Lom/NBC News
When Rambha Gajre and her family faced eviction from their cramped hut in Gujarat, India, she signed up to be a human guinea pig in drug trials for foreign pharmaceutical companies.
Hauling bags of concrete mix for $1 a day wasn’t nearly enough to pay back the money she borrowed to pay a doctor to repair a hole in her son’s heart, let alone feed her family of five more than one meal a day.
“Many people commit suicide,” she told “Dateline NBC,” “and I didn’t want to become one of those and I didn’t want people to think I did it to avoid repaying. I have two young kids, 10 and 12 years old. What would become of them?”
So Rambha did what thousands of other desperate women and men from India’s slums, and across the world, now do to survive -- she signed up to be a human guinea pig in drug trials for foreign pharmaceutical companies.
“I am helpless, I have to do this,” she said. “They don’t really force us, but I don’t have a choice.”
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Now, with the money she earns from drug studies -- up to $250 per trial -- Rambha is slowly repaying her loans.
Drug trial outsourcing to foreign countries is rapidly becoming an attractive alternative for pharmaceutical companies that are looking to save millions of dollars, avoid regulatory scrutiny and tap into a seemingly endless supply of drug study participants.
Americans fill four billion prescriptions each year. But some medical experts question how strong the safety net is that keeps unsafe drugs off the market. Dateline NBC's Chris Hansen reports.
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.
Foreign drug trials have become crucial to pharmaceutical companies looking for approval from the U.S. Food and Drug Administration to sell their products to Americans. Eighty percent of the drugs that the FDA reviews for approval now rely on some tests done on foreign soil, according to a 2010 report issued by the U.S. Health and Human Service’s Office of Inspector General.
The same report included another startling figure: The FDA inspects fewer than 1 percent of foreign drug trial sites, a number slightly higher than the percentage of sites inspected in the U.S.
“We have no idea what's going on in these clinical trials,” said Dr. Carl Elliott, a professor at the Center for Bioethics at the University of Minnesota and author of “White Coat, Black Hat: Adventures on the Dark Side of Medicine.”
Elliot worries that the lack of oversight in foreign drug studies leaves poor, and often illiterate, people vulnerable to exploitation when companies consider test subjects part of a profit-making equation.
Tim Sandler/NBC News
"Dateline NBC" correspondent Chris Hansen interviews "Rekha," another drug trial participant, in her home in Gujarat, India, which she shares with her husband and six children.
“The faster you can get the subjects, the faster that you can do the trials,” he said. “The faster you do the trials, the faster you get the drug approved. The faster you get the drug approved, the sooner it goes on the market and the more money it makes.”
Testing the Testers
With each drug trial costing an estimated $180 million in the U.S., many pharmaceutical companies are turning to places like India, where they can often pay less than half as much for their human experiments.
Some pharmaceutical companies, including Pfizer and Bristol Myers Squibb, have their own research operations in India. But other companies rely on foreign middlemen -- contract research organizations, or CROs -- to recruit patients, conduct tests, and analyze data that will be submitted to the FDA.
The proliferation of CROs in India worries Dr. Chandra Gulhati, editor of the “Monthly Index of Medical Specialties,” an Indian medical journal. Indian CROs, he cautioned, are entirely unregulated and unmonitored by the government.
“They've just come, opened the shop and nobody is asking them any questions,” he said. “To my knowledge, not even one trial has been monitored from A to Z. … They have no legal status in this country. Who are they?”
To test the integrity of those unregulated companies, Dateline set up a fictitious pharmaceutical company called Malum Kinetics. The company was little more than a $13-a-month homemade website, a post office box address in New York, business cards, cell phones and an answering machine.
Using publicly available information, Dateline put together a plan to test a drug identical to Vioxx, a pain reliever withdrawn from the market in 2004 and linked by studies to thousands of strokes, heart attacks and deaths. The plan was virtually the same one that Vioxx’s manufacturer, Merck, used to test whether Vioxx could shrink colon polyps. The test was halted after Merck discovered an increased risk of heart attacks and strokes.
Dateline producers removed Vioxx’s brand and generic names from the plan, but left in other red flags that clearly identified the drug, including the drug maker’s original abbreviation for Vioxx: MK-0966. A simple Google search shows MK-0966 is Vioxx. The plan also included other simple clues, such as Vioxx’s chemical name and its approval history as a pain reliever.
The test: Would the CROs have the basic scientific knowledge to question proposed experiments on humans with a drug already withdrawn from the worldwide market? And how thoroughly would a foreign CRO check the legitimacy of an unknown drug company offering a potentially lucrative business opportunity?
Dateline sent the plan to two prominent Indian contract research companies, Lambda Therapeutic Research and Synchron Research Services. Both firms claim to do business with large pharmaceutical companies.
Along with reviewing the Dateline study plan, they were asked to develop their own plan to recruit patients, get necessary approvals, and run the actual tests.
Both companies put together plans, and meetings in India were arranged.
‘Doctor is God’
In the sprawling central city of Hyderabad, Synchron’s director of clinical operations, Narasimha Murthy, warmly greeted Dateline correspondent Chris Hansen, the purported CEO of Malum Kinetics, and his team (all of whom were outfitted with hidden cameras). They were escorted to a bare-bones conference room in a building prone to power outages.
During a laptop PowerPoint presentation, Murthy said that Synchron was well equipped to manage a drug company’s testing from start to finish.
“It’s one-stop shopping,” he said.
Murthy never indicated that he knew the drug he was bidding on to test was identical to Vioxx.
In fact, he told Hansen that he showed part of the plan to private doctors who would be conducting the clinical trials and they did not spot any safety issues.
“They have not come up with any queries as such,” he said. “They have no issues.”
Murthy also noted that those same doctors would not have a problem finding patients to test the drug. Poor patients getting free treatment obediently follow their doctors’ orders, he assured Hansen.
“Doctor is god,” Murthy said. “So if I go to him, I will blindly follow what he says.”
Related story: How poor Indians are recruited for clinical drug trials
Synchron, he said, was ready to move ahead with the plan to test Malum Kinetics’ drug on humans, though he raised the prospect that an Indian ethics panel might have concerns -- not due to safety risks, but because some patients in the study would be receiving a placebo and would not benefit from the drug.
“Personally, I don’t see any issues,” he said. “We can do it. I am confident that we can do it.”
The price tag: just over $1 million.
Hansen was invited to meet Murthy a month later at a huge expo in Chicago, where drug companies and hundreds of potential contractors from around the world were to gather to promote their products and services.
Dateline's Chris Hansen confronts Narasimha Murthy, director of clinical operations for Synchron Research Services, an Indian company that claims to do business with major pharmaceutical companies, at a trade show in Chicago.
When the two met, Hansen disclosed to Murthy that he was in fact a journalist, not Malum Kinetic’s CEO. He asked how it was possible that Synchron did not pick up that the drug they were to test on humans was identical to Vioxx, a drug so potentially dangerous that it was withdrawn from the market worldwide.
At first Murthy said Synchron would have detected it after more research. But minutes later, he claimed the company knew what the drug was all along.
“We did pick up, we did pick up,” Murthy said. “But the only thing is we didn’t share it with you at that point of time. We didn’t bring it to your notice.”
Synchron, he added, would never have agreed to take on the test.
“We definitely wouldn’t have taken it up,” Murthy insisted. And, he added, an Indian ethics committee would have found problems with the study too, contradicting his optimism about getting approval during the meeting in India.
“The ethics committee would definitely halt it,” he said before turning away and walking back to Synchron’s promotion booth.
‘This is a very risky trial’
Dateline’s meeting with executives at the other CRO, Lambda Therapeutic Research, in India ended more contentiously.
In the fast-growing western Indian city of Ahmedabad, Lambda’s immaculate headquarters and test facilities rise above desolate slums that supply an endless stream of drug study volunteers.
Armed guards met Dateline’s team at the gate and directed them to an expansive reception area. A sign greeted them: “Lambda welcomes Mr. Hansen & Malum Kinetics team."
Dr. Philip Mathew, a Lambda vice president who ran clinical trials for a contract research company in the U.S. before joining the firm, led a tour of the vast facility, pointing out offices, labs and scores of human test subjects.
“These are our volunteers,” Mathew said, walking past test recruits watching a wide-screen television in a waiting area. The test subjects earn an average of $150 per study, he said, noting it was a fraction of what researchers in the U.S. would pay their volunteers.
“That’s for the entire study, as opposed to, say $150 a day, which is what the U.S. rates are,” he said.
In a plush boardroom, Lambda’s presentation was projected onto a large screen. One company executive said four specialists, all physicians, had reviewed the Malum Kinetics plan.
“They came to the conclusion it’s practical,” he said.
Lambda’s price tag for the project: $775,000.
Well into the discussion, Mathew raised a concern that suggested he knew that the proposed study was fictitious. After months of correspondence with Malum Kinetics, he said his team had just realized the test drug was the same as Vioxx.
“It’s withdrawn currently worldwide, right?” he said. “It’s not sold …This is a very risky trial.”
But rather than turn down the business because of the drug’s potential deadly side effects, Mathew said Lambda was still interested in getting the trial started.
“We are willing to give it a fair trial,” he said. “We are in the business of doing research regardless of how challenging the project is, but we have to be also realistic.”
Mathew and his team said they would need to take precautions to protect patients, such as monitoring those with cardiac risks and lowering doses if necessary.
But the major challenge, he explained, would be persuading an Indian regulatory board to approve human testing.
“We have to have a huge, huge scientific argument to make the case for doing a study with Vioxx,” he said, noting that Malum Kinetics would have to help Lambda prepare a scientific case.
To help build the scientific argument, Mathew proposed a strategy: hire a well-connected medical opinion leader as a consultant to persuade Indian regulators to allow the drug be tested on humans.
“Nothing works like consultants from within India who are in this field who can speak for the drug,” Mathew said.
By paying a $5,000-to-$10,000 consultant fee, he added, “We can take whoever we want who is a big heavyweight in India.”
Asked how confident he was that a consultant could help make a winning case for a drug like Vioxx, Mathew replied, “Very confident. Very confident.”
He estimated the odds for approval were “fifty-fifty.”
“From our perspective,” he added, “we’d love to take on the challenge.”
“Lockdown now!”
The meeting ended with Lambda ready to take the study to the next level. With most of the executives gone from the room, Hansen pulled Dr. Mathew aside, and, with two open cameras now trained on him, informed the Lambda executive that he was a news reporter. Malum Kinetics, he told him, did not exist.
“I knew that,” Mathew said, laughing nervously. “You must be out of your mind to come here with a withdrawn drug.”
Unaware that hidden cameras had recorded the entire tour and meeting, Mathew backpedaled.
“We are fully aware of the risks of Vioxx and we never agreed to do your study,” he said. “We want to discuss with you what this is all about.”
Hansen reminded Mathew, “Even after we talked about this being Vioxx, you said that we could go ahead and very likely do a study.”
“No. Fifty-fifty it will get rejected,” he replied.
“Fifty-fifty we could go ahead,” Hansen said.
Mathew said he took offense that Lambda’s integrity was being questioned.
“We stand for ethics,” he said. “We work for sound scientific principles.”
Another Lambda executive, Mrinal Kammili, stepped in and angrily declared the interview over. With the tension in the room rising, Hansen told the executives, “If you want us to leave, we’ll respectfully leave.”
But Kammili blocked the door. Raising his voice, he told the NBC crew, “Please have a seat! Please have a seat!”
“You can’t hold us against our will,” Hansen said, moving toward the doorway.
Kammili responded that they were calling the police, and once again insisted that the crew be seated.
Security guards at Lambda Therapeutic Research, a contract research company in Ahmedabad, India.
Mathew yelled to other staff in the room. “Call security! Lock the doors! Lock down now!”
A security detail quickly arrived to guard the door, detaining Hansen and the rest of the Dateline team for nearly five hours.
Local police arrived and logged complaints from Lambda and the Dateline crew, who were eventually escorted out of the building and brought to a small police station.
After reviewing the allegations, the top police inspector informed Lambda’s executives that the Dateline crew had not violated any laws. The crew was free to leave, he said, on the condition that copies of footage taken openly at Lambda be provided to police and Lambda executives. Neither group was aware of Dateline’s hidden camera footage.
Assessing the risks
Dateline took its findings to former FDA Commissioner Dr. David Kessler.
“No contract research organization should undertake any clinical trial without being sure that the risks are acceptable in light of the benefits,” he said. “And in light of what was known, that conduct is just totally unacceptable.”
Kessler said questions about the integrity of foreign drug trials, and those who run them, will only increase until a universal system is in place that roots out unqualified researchers.
“Any doctor who runs a clinical trial should be certified, should be trained, should have specific qualifications to do those trials,” he said.
Doug Peddicord, the director of the Association of Clinical Research Organizations, defended the industry's track record.
“Concerns notwithstanding, on the whole the clinical research enterprise is amazingly safe and amazingly productive,” he said.
Peddicord, whose organization does not include Lambda or Synchron as members, says there is too much at stake for the industry to tolerate unethical behavior.
“In the instances where we have seen bad actors,” he said, “we’ve often seen that those bad actors go out of business rather promptly.”
The pharmaceutical industry's lead trade group, Pharmaceutical Research and Manufacturers of America, declined comment.
U.S. Sen. Charles Grassley, R-Iowa, an outspoken critic of the FDA’s oversight of pharmaceutical companies, faulted the agency for not taking a more active role in policing clinical trials from the very beginning.
“They don't oversee those clinical trials until most of them are completed. Then they see the results,” he said. “To what extent can they trust the results?”
The FDA declined requests for an interview, but said in a statement that the agency is already "strongly engaged in the clinical research process" -- from inspecting drug makers and their contractors to monitoring drugs after they are approved for sale.
The agency also said it is establishing international offices to "improve its ability to oversee" the growing number of foreign drug trials.
Kessler believes the situation will not improve until Congress provides the FDA with the resources it needs to more fully monitor and regulate the clinical trial system.
In the meantime, Kessler worries about the ongoing risks -- risks for volunteers testing the drugs and for the people to whom they are ultimately prescribed.
“What's going to happen, and I can predict this … it’s been the history over the last 100 years. We don't act until there's a problem.”
“Until people die?” Hansen asked.
“Regrettably.”
Leave a Comment:
If you can accept the outsource of our computer, technology, accounting, and customer service jobs, then you should not whine to America about the outsourcing of drug trials that put you at risk. Poor people in America participated in these trials for decades and were not compensated for it. If you do not want the risk get off your a$$ and get a job in India. There are plenty of them available, that is the real reason so many Americans are out of work- Someon In India Took Our Jobs.
Not true. The real reason so many of Americans are out of work - Someone in America gave your job to India.
Isn't the naked greed of unregulated capitalism pretty? Do we want the FDA to keep us safe? Fund them. Oops, you can't do that and save us from the, "nanny state." Another thought: stop funding the FDA with money from PHARMA. Even an idiot can see a conflict of interest there.
The reason we pay taxes to a government is to ensure some level of social oversight. The amount we are willing to pay will be part of that. The amount of private sector money we totally block from getting into the government will be the other part.
I see the same issue in USA occurs
People have kids and cannot pay for them... then pray for some spiritual entity to help them.
theCavalier
Fund the FDA? Really? So they can control our salt and soda and take literally decades to decide to warn people taking statins. They did after all approve these drugs and the many others that end up being taken off the market AFTER harm is done. Recall after recall. New warning after new warning years and in this case decades after people have been exposed to the drugs. Yeah, the FDA has done a bang up job. They sit around thinking up pizza is a good school lunch while the drug that is needed to save kids with lukemia goes out of production, or is limited in production and do nothing. Oh, yeah we need more bureaucrats in that business drawing fat checks and golden pensions. The federal government was not ever intended to be a social oversight organization and for it to try to be is against our Constitution, they must be why they get away with doing a lousy job at everything they touch.
As to India, hey they have a very strict caste system and consider those in the bottom caste no better than lab rats. Send our medication production there and this is what you will get along with phoney test results that will lead to further late in the day warnings of dangers from the drugs they produce. But hey our administration recently approved their companies to make the generic version of the statins which son of a gun became dangerous right after the patent expired. Imagine that. Cooincidence, I wonder?
You nanny state people seem to be fine with all the corruption, but then those who would have a government carry them from birth (which is opptional) to death are not too smart anyway.
India is under a caste system. Depending on what caste you are in society determines what kind of work you can and cannot find. Upward mobility is very limited. If you have a job where you make a dollar a day, that's pretty much the only type of job you'll ever be able to get for the rest of your life no matter how hard you work.
Most Americans can't name 10 countries outside America and yet people like you think nothing of writing stuff such as above. What do you know about India if anything ?
Well let me tell you this - The caste problem in India is no better or worse than the race problem you have in America. Indeed, India - in all of its 5000 years of casteism has never held anything similar to "hunt a nig**er" day like you guys used to do as lately as the 1940s.
This article has a couple of misleading points:
1) The $180 million quoted for clinical trials is not true. When the drug companies were saying that it cost them a billion dollars to bring a new drug to market, the CBO investigated and determined that the most expensive drug every brought to market was Vioxx at $180 million, far from the claimed billion dollars. But this was the cost of the acquisition of the drug patents from its discoverers (it was discovered using taxpayer funds from NIH by academics), the cost of the trials and advertising along with "miscellaneous" expenses that presumably included stiff bribes to FDA officers.
2) A new drug need only be demonstrated to be "safe" and to perform as least as well as a placebo in two separate trials. All trials which show differing results can be withheld from the FDA. The reason Vioxx cost $180 million instead of a more typical $30-40 million was that they had to conduct as many as 34 trials to get the two they needed. When people would have a coronary/vascular "event" they would be shown in the study as "voluntarily dis-enrolled." In fact, there were a number of deaths during the drug's clinical trials.
3) Over the years, PhD scientists at the FDA have been largely replaced by MD's and JD's who have exactly zero training or skills in designing, conducting, or evaluating clinical trials. This causes them to rely entirely on the drug companies themselves to guard that particular henhouse. But when you have unskilled American physicians evaluating trials conducted by foreign physicians in another country, you have a recipe for massive fraud by the drug companies.
4) FDA officers are required to disclose their finances and are forbidden to have active financial links to the for-profit medical industry. Only about 20% have disclosed their finances and of that 20% about half have forbidden financial connections, often taking the forms of "luxury seminars" for the physician and his family in the Caribbean, "honoraria" for speaking engagements, proof-reading journal articles, and for "authoring" journal articles that they never saw until their publication. College tuition "loans" are very popular right now as bribery. And there is always the revolving door that allows physicians to retire from the FDA and take a lucrative job (they start at around $350k a year) with a pharmaceutical company.
We need to stop some of these practices. The use of foreign nationals for clinical trails ahould invalidate them. Physicians without the necessary research skills, and the credentials to prove it, should not be employed by the FDA. All FDA officers with financial links to the for-profit medical industry should be fired. All FDA officers who refuse to disclose their finances or disclose them inaccurately, should be fired. Clinical trials should never be able to be suppressed for any reason --- all clinical trials should be considered as a single aggregate. Drugs should not be approved unless they are significantly better than a placebo (which would eliminate about 30% of all new drugs) and they offer something better than drugs already on the market.
You have to remember that medical malpractice is the fifth leading cause of death in this country and prescription pharmaceuticals play a big part in that statistic.
Chris is correct. I was hired to conduct drug tests at a major California campus. After three months it became obvious to me that the University depended on the huge sums of money that the drug companies gave to them. The chair and the IRB had little interest in how the studies were conducted and were not providing the oversight needed for the testing program. There was an enormous amount of pressure on the staff to show a positive outcome for each drug. The supervisor and staff who were doing the testing were being offered numerous "perks" to conduct the testing. The drug companies sent out their staff to monitor and coach the University staff to assure a good outcome for their studies. The testing area supervisor did not train her staff adequately and cross contamination and exposures to blood borne pathogens were always a looming problem. When I reported my findings to the supervisor, the University responded by black listed me. The University eventually settled with me after I filed a law suit but no one at the University was disciplined. The drug companies provide an invaluable service but the means used to test their new products should be evaluated by the FDA much more frequently and aggressively.
Chris, all wonderful, logical ideas..so, you know they won't be implemented. In the meantime, without all of these 'new' drugs, what would Mr. Subliminal do? No more talk overs for new 'wonder' drugs with side effects that outweigh benefits.
Don't be surprised of the majority of diseases are caused by pharmaceutical companies and their drugs.
Eat healthy, drink in moderation and exercise and pray you never get anything and avoid taking prescription medications at all cost.
That sounds like facts Chris, and we all know how facts go over with certain people who consider their opinions to be facts and anything that conflicts with their opinions to be propaganda. In fact we should all be hounding our government about this and other issues surrounding for profit medical treatment and research because the very notion of profit in the medical industry is a violation of the Hippocratic oath we all take when studying for certification in the medical industrial complex. Great post BTW Chris.
No thanks for American companies offering them another way out other than suicide? They can also choose from one of the many job opportunities that we have shipped to India as well! How much more opportunities do we have to provide for these people? Are we supposed to feel compassion that we are not offering these people enough of a safety net? We have our own damn poor to worry about!!!!
oversight = big government. so if india lacks oversight, good for them. it sounds like we could learn a thing or two about the free market from them.
Mark-1219747, your comment is half true. the problem is that people in America have become complacent, they dont want to work, they rather stay and home and let the ever corrupted government continue to provide for them....why go to work when you can have 2,4,5 kids and let FREE help come in.
Your sir are as clueless as you are idiotic.
That is 100% false .. Don't blame Indians for outsourcing .. Blame the companies which took your jobs abroad. Here are few things i would like to bring to your notice about companies going to India because
65% countries population is youth , Maximum number of graduates every year and every body know English.
1. American companies -- spend average 700$ a month just for medical insurance for an employee which can be 1 persons salary in India . So they are saving whole salary of that employee.
2. Average IT professional in US gets 5000$ with that amount they can have 5 guys in India.
3. They don't have to pay medical benefits, other bonus, or any benefits and all those things are headache of Indian companies.
4. Please Don't blame India or any other country for that .. All you have to blame is US companies which shift its operation .
5. Every body wants cheaper products , you will not buy a T-shirt for 80$ which will cost ,if it is made in USA , there it will cost 10$ and companies selling for 20$ .
6. Everybody is benefited in some or the other way every single day for the services or commodities you use.
7. Ratio of Graduates from India to rest of the world will be 3:1 in science & Technology.
Kornfed,
Congratulations on displaying the highest level of ignorance I've read on this post. These people are supposed to be grateful for American Corporate exploitation! COME ON! Don't you see that the rich are powerful are exploiting them as well as American citizens so that they can make even larger profits.
The greatest tool against this type of exploitation is knowledge, (which you need a lot of my friend), along with a human race that displays compassion and caring. (I know - that is a stretch.)
I kind of breezed through the posts so excuse any duplication; This is a classic case of life imitating art! I just read a book by John Grisham where a major drug company was sued for a bad drug and it turned out that all the "testing" on this drug was done in foreign countries. Poor people got paid, many died and the drug got approval any way. Grisham apparently pays closer attention than the FDA! I find animal testing reprehensible as well and I'll just bet if those greedy drug companies paid more money there would be plenty of people here who would volunteer. There would be (I would hope) more oversight and the end result would be a better drug.
America has a caste system and it's very difficult to have upward mobility. Poor people are treated like lab rats.
Kornfed,
Personal attack...not predictable or anything.
The last I have checked, India's people are free enough to resist the exploitation if they so choose. Also, on the bright side, this allows for less corporate exploitation of our own Americans.
Thats why I come to the vine...to be enlightened on how to be compassionate and caring! Thank you for leading by example!
Another reason to not find objection with volunteers...the animals do not have a choice.
De-regulation is a good thing - right? It has become the chant of the republican party. The republican minders (the oligarchs who own or control the major industries of the world) don't want to have any oversight. They could care less about the suffering and losses these people face. Hopefully this type of journalism will get the FDA off its lazy a$$ and get Congress involved in funding the FDA inspections where ever the testing is being done.
Not De-regulation, less regulation. Let me ask you a question Michael...Who has the advantage, a big corporation, or a small business man, trying to set up shop in any industry when there is excess regulation?
This has probably been going on for years, and in other poor countries too. And it unfortunately probably involves a lot more than research on drugs.
"The last I have checked, India's people are free enough to resist the exploitation if they so choose. Also, on the bright side, this allows for less corporate exploitation of our own Americans."
"So Rambha did what thousands of other desperate women and men from India’s slums, and across the world, now do to survive -- she signed up to be a human guinea pig in drug trials for foreign pharmaceutical companies." --
Kornfed, it appears you are incorrect. Survival is not freedom.
Kornfed; I wasn't advocating volunteers from other countries. I propose they do it right here in the USA and pay a decent wage with full disclosure!
There are other problems with conducting these drug trials in foreign countries like India are not discussed or even mentioned in this article. These problems would exist even if the trials were run with the highest of standards. The first issue is that, while minor, there are genetic differences between the Indians being used in these studies and the typical American. This could have an impact on the results of the study with some problems arising that might not occur here or worse, problems not showing up with the Indians in the study that might occur here. A second issue is that the typical Indian diet is far different from the typical American diet. This could lead to unreliable results since a persons diet can definitely have an impact on the effectiveness as well as the side effects of certain drugs, particularly drugs that are plant or animal based. The best way to conduct a drug trial is with test subjects from the same social and ethnic group as those who will eventually be the ones getting the drug. This is why drug trials in the US try to use a cross section of the population in the trials. This helps to ensure that problems that might be specific to a certain ethnic group are uncovered during trials. I realize that these ethnic specific issues are not that common, but they do most definitely occur. Conducting trials for a drug intended for the ethnically diverse US market in a country that lacks the same ethnic diversity has the potential for leaving problems undiscovered during the trials phase.
And here is an interesting bit of trivia for one to conjecture when considering animal experimentation. In fact, the F.D.A. does not even require animal testing for drug approvals.
fgh, that makes it even more disgusting.
Chris-749391 Post #1.7 Thank you for your post. I frequently find your posts to be factual and well written. What do you do with them after you have hit the "Post Comment" button? There has to be more. It needs to go farther than just "The Vine." I have been giving some serious consideration about having a long weekend party at my home. The list of guests will be from a select group of "Viners." and their family. I do this with my large family and extended family. It will be a nice catered affair with good food and drink. There is plenty of room and the children generally find themselves in a tent, with other kids. by the water. Do you think people would come? We could all put our minds together with the goal of going beyond just a mere post.
Michael Bishop-1520606 post #1.8 Thanks for your post. You may want to reconsider your last sentence. The old saying about the fox and the hen-house............
Kornfed post #1.12 You might just be interested in reading about Monsanto, the World Bank, and the related suicides of Indian farmers.
I've actually participated in drug trial studies in the US. (As a practitioner, not a patient) Rest assured that it doesn't take much to get a drug approved.
Mr. Cool- 1.28 - In making entries in forums like this you have to rely on a basic knowledge of the subject matter and stay within the context of the subject at hand. That being said, are there any other entities that have the same charter and charge as the FDA? Since there are none, I would add to my previous statement that this administration should increase the oversight for all medical research as part of the Affordable Medical Act. You might suggest gutting the FDA and starting from scratch but there are people in the FDA who understand the problem and only need the resources to do their jobs. What was not covered in the article is the undue influence that big pharma has on the FDA. Kessler started down that path before he left the FDA and no one kept up the momentum. Lets hope this administration has the backbone to get it right this time.
Yes, don't blame the Indians. Blame the crooked US politicians who are in bed with Big Pharma for allowing this kind of 'research' be used to approve new drugs.
Wow India sounds like a great place... For all you repugs to relocate to.
Michael Bishop, do you see the irony in wanting our current president and administration to have the backbone to set up proper checks and balances in any issue concerning big business, when he has set records in fundraising while declining any Government contributions to his campaigns as to do so would limit his ability to accept the funds he has raised? The only real difference I see between Bush (Jr.) and Obama (besides lots of lip service) is "Obamacare" which is so badly written that it will most likely be gutted due to sections being unconsitutional.
Maybe people so poor that they make a dollar a day shouldn't be used for clinical trials in the first place. This group of people would be very prone to undiagnosed disease due to lack of quality medical care. They would also be more likely than others to have been exposed to toxins and other harmful contaminants. Many could suffer from malnourishment.
These and many other factors seem like they would heavily impact the results of a medical clnical trial even when patient screening is practiced. These people are used only because they are easy to exploit. No one hears about it when these participants die during a trial.
The FDA should absolutely take foreign trials into consideration but should base final judgement on domestic trials. They should also be privy to all trials, as apposed to only the most sucessful. There should exist provisionary use of new drugs that are so beneficial as to outweigh the potential risks such as is the case with the terminally ill and those with advanced Alzheimers. This provisionary period would end upon sucessful completetion of domestic trials and full approval by the FDA.
@Mr. India:
You don't seem to know too much yourself. I've lived in India. I saw on a daily basis that low-caste people there are MUCH worse off than African-Americans here. Yes, sir! Yes, sir! The caste problem in India is much worse than the race problem here. And you have no authority to scold people on their ignorance. Your so-called "hunt a n---days" are no longer and were rare when they occurred. Things as bad as that DID happen in India throughout its 5000 year history and still happen today in the rural villages. Caste violence can be appalling there, even today.
The FDA is a federal program,therefore it is not doing what it should to regulate what BIG PHARMA does in regards to proper development,testing,and marketing of prescription drugs. The scary thing is this same agency of do nothing morons are also responsible for making sure our FOOD is safe. All prescriptions sold in the U.S. should be made in the U.S.
absolutely...who needs pesky oversight agencies such as the FDA, OSHA or the EPA?
Why, just look at the Bophal disaster to see how well the Indians manage without them...
Another by product of the Caste sysytem, Hey India!! Evolve Already!!
I can almost gaurantee you none of the higher castes have been turned into guinea pigs for big pharma.
Its poverty that drives them to turn into guinea pigs. And the rich world thrives on these experiments.
That's a rather ignorance perspective. Caste has nothing to do with socio-economic status. Poor people are poor people - doesn't matter if they are high or low caste. The market on exploiting poor people for profit is not the sole preserve of these clinical research orgs or Indians.
Your understanding of the caste system is ridiculously ignorant for you to make any kind of educated comment about it. I suggest you take your own advise and "evolve already!"?
Ian
What part of Caste do we not understand? If there are still Caste, never mind what laws are on the books, there is discrimination and that means Elites, lessors elites, average joes and then the untouchables.
We will guess you are a member of the elite and of course there is no impact on your life.
Ian - It seems as though you are pretty ignorant of what a caste system is. You're born into it and it is next to impossible to move up in it. If your father worked cleaning out the sewers for $1 a day, you can almost bet that your great, great, great, great grandson is also going to be cleaning out sewers for $1 a day. It doesn't matter how hard you work, you are stuck in the position you were born into.
Coral Taxi : When you have evolved enough to eradicate racism from America feel free to lecture India about its caste. Until then STFU and go back to listening to Santorum rabble rouse against gay people or Rush Limbaugh calling students half his age a slut and a prostitute just for advocating contraception.
Wow - The nerve some people have.
We have a caste system here in the US also. in fact, everywhere in the world there is a cast system.
Mr India,
You are crippled (not challenged!) by your own hate.
MrIndia, Your Telephone customer service job is waiting .
@ Mr. India; I would say from slavery to being the leader of the free world is quite a bit of evolvement wouldnt you sir? Do not equate me with Rush or Santorum I am, me myself, and I.
This is not about race really,it is about knowing your place in society,how you are expected to act, because of the family you were born into, it is based on occupation and lineage. Let me tell you your people are not little children who should have to "know their place" holding people to a certain standard they are born into surely stunts your growth as a society. Which is why yours is still rife with corruption, disease,poverty, bribery.
People are dying in hospital fires because they were left by the attendants to die, the fire trucks do not show up for over half an hour,many numerous car accidents, building and bridge collapses because of shortcuts and shoddy work due to kickbacks and trying to save a buck on materials. I have a larger list in a previous post if you wish to press on.
It is far overdue for India to evolve away from the Caste, they are not as bad as they used to be, but discrimination is still high.
Re post from seperate article; 1/2/12
It is a completely logical assumption that if you hold a certain group of people down in a society,that eventually someone is going to get hurt,or killed as a direct result of it.(animosity,ignorance,prejudice,breeds violence) This could not be truer in this case.Im not saying other countries have not been guilty of it,I am saying it is time for them(India) to allow the lower class,the same opportunities afforded to those born to the more priviliged. Evolve already.
I am not trying to insult,more than express my disgust that these type of things happen because others think their lives are more valuable than others. Get it?!
#1.12 - Mon Jan 2, 2012 2:46 PM EST
Coral : Not saying India does not have a caste problem but i am from India. I know the extent to which things have improved. Lower castes have risen in status all through India though affirmative action and other programs. It is a 5000 years old disease. It takes time to eradicate it. In most urban centers and in cities nobody gives a damn about what caste you are. But vestiges of casteism can still be found in rural India and other backward areas. Lower castes have recourse to all the democratic institutions in India and they have been making use of it to elevate their station in life. The chief minister of the most populous state in India is a person from the lower castes.
Your race problems is just 300-400 years old. You have been independent since 1776. When you have not been able to remove it completely from your societies completely how and why do you expect india to have removed its caste problem which is 5000 years old, in mere 70 years since its independence ?
Bottomline is that India has the right mechanism in place - the judicial and constitutional protections - the educational processes - which are needed to remove the ills of the society. It will take time and it will happen as it has been happening for last 70 years - In the meanwhile India does not need your patronizing tone.
As for the person telling me that my telephone operator job is waiting - I have a six figure income from a proper IT job - A result of 18 years of education with a BS in science and math and masters in computer science. You should go - Your welfare check is waiting.
Coral - India abolished caste system in 1947. Remnants remain --- just like in US. But to India's credit - India has had a "so called lower cast" president and prime minister and numerous other highest posts in government or in private industry way way before the blacks were able to do in US. It took close to 3 centuries in US and even today Obama is treated like dirt by racists governors who welcome him with a finger!! Come on ... who needs to evolve?
Another thing .. guys ... outsourcing by itself is not the problem. The world has prospered because of trade. But it is the pace of outsourcing that doesn't allow individuals to cope up with the changing situation. The pace of change also creates unfortunate situations such as these drug trials where a few companies make billions while playing with the health of Indians as well as Americans. And honestly I don't think even the drug companies are at complete fault. The governments need to evolve and create a level playing field in the areas of health and security.
The US has a caste system--we just don't call it that.
@ pj;
yOu are surely sugar coating, the caste system is still alive and well, even though discrimination is not allowed "on the books" More than remnants remain. Explain to me why those of a lower caste still have to pay additional fees to go through medical school that the upper caste does not have to pay.
You see it starts from the very beginning of Med school, and others more than likely, the seperation,the "this is who you are", pay more, you on the other hand do not have to, doublestandard all the way, still designed to let people know their place, remnants? Yeh right.
India needs to evolve, even MrIndia admits this, I am not trying to down anyone, just fed up with watching people die over an antiquated system. India is letting her people down period.
Racist Governors? You are funny, this is not 1960 mam.lol A majority of those "racist governors" helped him into office, and I doubt any American welcomes their president with a finger,like him or not.
Not so called mam. just ask the med students.
Exactly a LEVEL playing field.
Coral now you are giving absolute BS. Quite the contrary ... lower castes if at all pay lower fees in India in Med engineering and all kind of schools.
Also, WTF is with mam? You fell on your head or something? How do you know mam or sir or child or adult. Just stick to the topic and stay with what you know.
Wow ...seriously ? WTF are you talking about man ?
Here is how it works in India - All the government controlled colleges - MEdical and Engineering - including the world class Indian institute of technology, Indian institute of management and All india institute of medical sciences - They all have quotas for lower castes and minorities. to the extent that if their are 100 seats available, then only 40 are available to regular indians. The other 60 are reserved for candidates of lower castes, backward tribes, backward classes, women and religious minorities.
Same thing happens in government jobs.
So basically, you don't know what you are talking about and i would really appreciate if you either shut up or research more before you post again.
Boomer - And you are crippled by your ignorance of a country and people you know nothing about except what you read in your media which itself is a result of sensationalist journalism. That same journalism that reports the murder of 1 lower caste boy in some remote village in India because it has story value but never reports the hundreds of lower caste boys who are often first in their entire extended families to graduate out of Indian Engineering colleges and gain employment - year after year after year - who wants to read those stories ?
We can't judge them by our standards. If they want to do away with their caste system, they will.
@ mr India ,and Pj whatever you are;lol
Not hardly,you just want to live in denial,read on.
The above is from a recent article. The higher caste does not pay these fees. Obvious discrimination as I said.
By your own words you admit the separation is still going on, regular Indians? 60 seats reserved for Lower castes? Why dont you just say "those people" and show your true pompous colors. You guys are getting angry and emotional because my words ring true,as you see above I back up what I say.
Way to twist my words to suit your narrative.
I give up.
PS - The entrance exam for medical school in India requires the lowest castes pay additional fees to take the examination - THIS here is complete and utter bull@!$%#. Cite a credible source please.
I googled - The source that you cited from is a BLOG post from a foreigner working in India and cannot be considered a credible source. Google some more , review the entrance criterion for the myriad educational institution in India and cite me where it says lower caste people have to pay an extra fee ?
@ mr.india;
The Caste System and Challenges for Seniors in India
Posted on February 28, 2012 by Aishwarya Bhake
You can not deny the truth in it sir, as hard as you may try.
[http://www.shesthefirst.org/2012/02/the-caste-system-and-challenges-for-seniors-in-india/
@ MR.India;
How much can a country care about their poor when they do not even try to give them identity? The government of India should be ashamed, but they are not because your "caste" system justifies their actions, even though they say it is being diminished it truly is not. Once again I will say
EVOLVE INDIA!!! Give ALL your people identity, not just the priviliged or the better off!!
Whoa there folks..what about the caste system in the US? Don't you dare deny it either, just because there is a possibility of upward mobility. It probably happens less than the lottery.
P.S. farbeit for americans to tell indians to evolve...
s@walker;
O.k here, let us see their own people tell them. Comparing America to India in the caste sense is ridiculous. I usually do not twist the sword but here goes. This was published 2/6/12
Now I have given you others(your own people) that say India needs to evolve, with recent examples why. with example and source. Get mad all you want to,but the truth is right in front of you, the disgusting fatal truth. As I said before the caste system is not diminishing, no matter how many laws are written against it.
You wanted it MR .India you got it.
http://www.thehindu.com/todays-paper/tp-national/tp-karnataka/article2864402.ece
Coral Taxi - change your name to BS Taxi. If you start naming blogs as your credible sources then good luck to you. By the way .... is there a chance that you supported lynching at any point of time? Just curious!
@ThaKhanKubla
"You're born into it and it is next to impossible to move up in it. If your father worked cleaning out the sewers for $1 a day, you can almost bet that your great, great, great, great grandson is also going to be cleaning out sewers for $1 a day."
This is a naive and simplistic understanding of the caste system at best. These are MANY different castes and compared to racism, the caste system is a benign form of discrimination. Even the man cleaning the sewers for $1 a day has a "choice" and his sons and grand sons have "choices". They can refuse to work, they can seek other work and they ALL get paid, unlike the slave system that exists in the US where slaves are not paid and are not even seen as human beings!
Why is that people see the "caste" to be some black and white system! It's not!
Just because you are of a higher caste does not imply you are part of the "elites" and just being from a lower caste does not imply you are "untouchable". Americans have a ridiculously myopic and ignorant understanding of the issue!
Firstly, "untouchability" is no longer practiced and is as common in India as "white only" water fountains are in the USA. Second, the highest caste consisting of "preists" called Brahmins are often much poorer than the lower caste "merchants". With more than half a century of measures many former "untouchables" today run enterprises and are captains of industry across India. Many others have converted to Christianity, Islam etc! Even during the formation of the Indian state in 1947, the man who drafted the Indian constitution and who educated himself in Oxford was a "dalit" or untouchable caste. Today the situation has changed dramatically. The caste system no longer holds any meaning in urban India and even in rural India, it's role is increasingly marginal with increasing inter caste marriages and the like.
It is easy and convenient to blame everything that's going wrong in India on "caste system" and then sit back and pontificate about how "backward" India is but that is merely an exercise is ignorance and condescension. India is an extremely diverse, multi-religious, multi-ethnic, multi-cultural melting pot where any stereotype is simultaneously true and false at the same time. Cavalier analysis and parroting popular platitudes serves no purpose.
This is patently untrue and in fact quite slanderous considering all the progress that has been made over the last 60 odd years! I don't know where you get your facts from but this is an outright fabrication.
If anything, the lowest castes called the "Dalits" have to pay far less fees than upper caste students. Further, a certain number of seats are reserved for these lower castes in almost EVERY university, college or school in India. Apart from having caste based "reservation", sex-based reservation and religion based reservation also exists. So out of 100% of seats in any institution, nearly 60% of the seats are "reserved" for students of the low castes, female students, students from minorities like Muslims etc. An upper caste hindu in today's India is severely handicapped and disadvantaged with all the "entitlements" and "reservations" given to others and has to work double hard to compete on a level playing field in any medical, engineering, technical or business admissions exam.
Even the Federal government's Legislature has "reservation" for lower caste candidates and women candidates. The probability of a lower caste "untouchable" becoming a doctor are much much higher than a upper caste hindu because even if a lower caste student scored 50% in a competitive admissions exam, he is almost certain to get a medical seat while an upper caste candidate who scored more than 95% would be doubtful of his chances of securing a medical seat in the same exam. Once admitted, lower caste candidate receive extensive benefits in terms of free tuition, free textbooks, free accommodation etc compared to upper castes! In fact this system has been so skewed towards empowering these lower castes that today there is growing concern about these lower caste candidates not being on par and meeting adequate standards of competency. further the argument is also made that rich lower caste families extensively use the system of "reservations" while the poorer lower caste members are out competed. The hardest hit are the poor upper caste Hindus who have no relief from any quarter.
Your arguments are openly naive and show a simplistic understanding of the caste system and India. So while it is true that India still has much distance to travel in building an free, equal and tolerant society, you can't claim that America's society is so much better than present Indian society either! Just because Obama is a "half-black " man and is elected as President of America (leader of the free world is a self-advertised title that is accepted only to Americans!) doesn't mean anything special to India when India has had Dalit, Muslim and Female presidents. In fact, the strongest politician in India today is not even born in India and is a naturalized citizen of Italian descent and a woman, something not acceptable in America yet!
So while India has many challenges in building a better, more equal and more tolerant society, India doesn't need the patronizing tone or some dilettantish analysis. To discount the strides made by India and talk about some perverse historical version as the truth today is patently slanderous and insulting to all Indians.
@ pj,ian;
Which part is not true p.j? Tell me then show me what part is not true with example and source as I have provided(and you have not). You will not because nothing I have posted is untrue.
The articles I have used are valid,one is from a teacher who has taught in India many years, and it is true the lower caste pay higher fees,and the Identity scheme does exist. The article is not written in a biased way,and backed up by example. The second is a long time dalit writer, who as I posted gives example(recent example) of how the laws are written but not enforced,and are very biased. Read it again. Tell me which part is not true then tell me why.
I am finding articles that are echoing what I am saying, after the fact of me saying it, This is not my first rodeo, holding India to account on how their lower classes are treated.
They are paying more fees while others are not, this is truth, if it is true it is not slander.
Because the higher ups could care less. They are not working to improve this,(where are these strides you speak of?) it has been this way for decades. But I gaurantee those of a higher caste do not have leaking roofs and no blackborads.
90 % of schools have no functional toilet? You say I can not say American society is no better?lol That is digressing off the point, but a ridiculous statement by you.,
How many of these ar dalits? Im guessing not many.lol
America is not even in the same universe as India as far as human rights.lol I can claim it and sing it to the skies. My argument is backed up with example and testimony by the citizens and teachers of India.
Discrimination still exists even though there are laws against it(caste discrimination) they are not enforced, and ignored by most states. The people that complain about this are castigated, and bullied into staying quiet. I am backing up what I say with source and example and you call me naive.lol
Greed,corruption, prejudice,keeping large segments of society "in thier place" not identifying ALL who are born. This has cost India lives and embarrasment, and also blunts creativity, and stops a society from EVOLVING into a fair and righteous country, where rule of law can sink in.
@ ian;
I have given recent articles and accounts within the past 5 yrs all the way to feb 28,2012. What "perverse historical version" have I given, or talked about name it.lol You as pj speak but back none of your accustaions up.
Did you not see the post where they banned books, let people out of trouble for honour killings, which have increased more in the past few years? Do you just ignore what I put in front of you? This is truth TODAY Ian.
What strides, at least name a couple, not saying you can not but at least give me more than a blanket statement .
Still most schools are without proper plumbimg and materials after 60 yrs??! Wow this is some progress. Maybe next week they (the lower castes) will get chalk.lol
@ ian and pj; Here let me drive my points home even more.
Report from 2010.
You see this goes to my point of the laws are on the books but not enforced, the motivation here seems to be ambition over the lives of young couples that fall in love and have to die, or face being ostracized, because of where their parents work, or their last name,(lineage). Just turn your head to killing councils,for the votes.Nice
This is recent news, not some "perverse historical version" as you say I am using which I have not, and do not have to.They are getting worse in some states not evolving. Who is anyone to say who another can be with? The caste is still strong in India,and not enough is being done by the government,only veiled attempts at stopping discrimination. Sad very sad, for India.
http://www.nytimes.com/2010/07/10/world/asia/10honor.html?pagewanted=all
See once again source and example, backing my points up. Do not sit here and tell me I am full of it. Your problem is you just do not like what you are hearing, as both of you have became agitated and insultive, which only shows me I have struck a nerve.
Let me tell you something about me. I love all serve all,Indian,Russian,American,they are all humans to me not a job,not just a name but a human I do not put myself above.
There are at least 1,000 honour killings in India a year, and only 27 cases in the past 5 yrs? "Historically perverse version"? I think not. Do you not see now why I am so passionate about India evolving? Even though this does directly affect me, it disgusts me to the core,and not only from India,from anywhere in the world.
Now is this enough facts and examples and source to show you I am not full of Bs? You call me slanderous, and ignorant, guess what you should know now that I am not either . I ma tired of opression in the world, and the women of the world still sufffering abuse and the "double standard" because men refuse to evolve and keep the weak down, and not protect them.
America is about the exact opposite, our constitution is designed to protect all from persecution and opression, especially those that can not protect themselves. We have uplifted our women, and minorities and are all the better for it.
So now it is about honor killings. I ask you about lynching and you mention honor killings. Way to go!!
@pj;??!!
This does not even make sense, to ask me this. Digressive and insultive. Where do you get I support lynching from? Did you really expect me to respond to this? lol
Your "lynching" question is more like an insult than a valid question. The honor killings relate directly to the caste system, and I made the point of the power these councils have to motivate others to kill, and ostracize. You are just angry because you can not argue the truth, I have laid before you.
The caste system is still alive and well in India, the leaders are still looking the other way when crimes are committed against the lower caste,I have proven, and made my point on this.(more than once on this vine)
Get over it. and hey India.
EVOLVE ALREADY!!!!
"Lynching" came from your obsession with caste in India or everything wrong with India. It seemed like you are allergic to facts and truth and are determined that certain people are sub-humane and need to evolve. So wonder how you would treat blacks and other people right here in US.
As per your sources the less the same the better. India is the mother of language, mathematics, philosophy, analytical thought, arts and much more. What you write about Evolve already isn't worthy of any response. Indians are one of the most tolerant and flexible people - just like Americans. They have a long history and yet they have undergone phenomenal transformation since independence in 1947.
Honor killings, hatred, racism, caste system, oppression, persecution, injustice exist all over the world. And humans are already evolving. Sometimes - good - sometimes bad. The way Iraq was attacked was thuggery. An "evolved" thuggery one that was carried out with better misinformation. One where cleverly God Country and Army was woven together to attack and kill hundreds of thousands.
But that would be "Evolution" in your opinion. Is that the kind of "Evolution" you want Indians to aim at?
# pj; @ ya know I took time out to educate you on the current state of Indias caste system. give you source, example, and the words and opinions of teachers and writers whom live there, and you come back at me asking why I did not answer to your insult, out of all the information I put in front of you?!! I have no problem with you disagreeing with it.I do have a problem with you not respecting the time I took in answering to you, nor do you even mention or discuss any of the points I have made.
Your emotions are overriding your ability to reason. I see it all the time when people are stumped and shown how wrong they truly are. My goal was more to discuss, and make my points, not just to "be right" as you have seen I truly care about this issue. You have no respect for that either.
Umm no it doesnt.
Still is not relevant. My poins were made.
I give you facts and source,where are yours you have offered nothing but your opinion.lol And you say I am allergic to the truth?
@ p.j
You truly do not get do you. Do you not understand it is the minorities and the "untouchables" I am rooting for,not the upper crust that chooses to ostracize them, and punish them for stepping out pf place. As I said earlier your emotions are overriding your ability to reason.
This is one of my post from December since you wish to keep equating my country with India, let me tell you nothing is farther from the truth.......
You guys are kidding yourselves Comparing America to India . America and Americans are the most compassionate, and caring people on earth, hands down. We send tons of grain to NK, yearly, we even feed our enemies,this is like India helping feed Pakistan.lol not gonna happen.No comparison there.
We also have people all over the globe risking disease and death, to help people have the basic neccesities of life. Red cross,missionaries,volunteers of all types, all Americans. Our billionaires run around in blue jeans and t shirts as do our richest CEOs at google,facebook,microsoft,apple, etc.They do not run around looking down on those with less money, or power, they take care of their employees, above and beyond.
Bill Gates, and Warren Buffet, have committed to giving at least a third of their wealth to charities, and have convinced other millionaires, and billionaires to give up a third or half of their wealth also. I could be wrong, but I do not believe their are any Patels on that list. I know the rich in my neighborhood and area, and if you do not know them, you would never know their wealth. That is how most Americans with money roll.ie They do not put themselves above others as in the Caste system. No comparison there either.
I am not saying there are no compassionate Indians, that would be ignorant, I am saying India's leaders and upper crust as a whole need to make the change and start caring about the lower classes, their pride and arrogance will not allow this to happen.
But do not ever compare them to us, and say we are becoming like them that is an ignorant statement. We have rule of law and checks and balances. They do not. My problem is the arrogance, and uncaring for the masses.
rail accidents, stampedes at over-crowded religious festivals, bus accidents, building collapses, and a world-record number of traffic fatalities, are among the hazards regularly reported across the country.
Government agencies seem to be ill-equipped or unwilling to provide basic public services or properly regulate the fast-growing private sector. Sometimes safety standards are non-existent or ignored, other times inspectors are bribed, often laws remain toothless because of lack of enforcement.
Like most developing countries, India has a poorer record on safety than the developed world. But data suggest India’s safety record is also far worse than the developing countries it is often compared to. According to data from the World Health Organization, India’s rate of “unintentional deaths,” or deaths by road accidents, fires, drowning and other accidents, is 59.7 per 100,000 people. In contrast, that rate in Brazil is just 40.3, and in South Africa just 30.2.
When you factor in Brazil and South Africa’s much higher rates of “intentional” deaths, or murders and suicides, India still comes out on top on deaths due to injuries, with 83 deaths per 100,000 citizens, versus 75.8 in Brazil and 63.8 in South Africa. Countries whose per capita income is comparable to India’s also have lower accidental death rates — Uzbekistan’s is 29.3 people per 100,000 and Vietnam’s is 52.2.
#1.14 - Thu Dec 15, 2011 4:47 PM EST
Now what PJ??!! Also shows that I am rooting for the "underdog" not trying to lynch them.lol
Poor safety record is not same as intentional killing of poor castes. This is misinformation.
So what will be evolution - "Killing Iraqis for Oil" ?
You as others are misguided on this, not that it has anything to do with our discussion, but look into who recieved most of the oil contracts from Iraq. it was not us, so your statement is not a fair one. Check it for yourself.
This is factual data(not misinformation,lol) and even if it was not exact, it still goes to show that India still lacks checks and balances, and rule of law, making a buck, or gaining more power still trumps the safety of their society as a whole. The caste system is still enforced in some states, while the elected leaders look the other way because these "councils" carry major voting blocs.
I believe many have died as a direct result of the higher ups(governments poor safety record), not caring about the masses, the lower caste. Making the deal, saving money on shortcuts, no regulation, are causes of many AVOIDABLE catastrophes in India. I believe this is as close to intentional as you can get.
Evolution for India would be holding onesself to account, putting others welfare and safety ahead of your own. Doing something for nothing(sacrifice). ie Not always coming out on top of the deal, at the expense of others safety, and security. To want to gain a sense of duty and honor over that of power and money.
Service to their people and country and not themselves. At this point in time I see none of this happening. I just see people dying for lack of enforcement and no regulation,and corruption, bribery. "making the deal". A way to identify all those born in the country, not just the urban areas.
You can not do much legally, without a SS number. They should have had a better system by now, the reason they do not is not ability, it is complacency, and an uncaring for the lower caste, whom are the victims of the "identity scheme". If you can become a nuclear power you should be able to give identity to all.
This would be evolvement for India. This must start at the top, they must set the example for the newer, and current generations who are trying to move away from the caste system. Population control is another issue, lack of education on contraceptives, religion not allowing responsibilty. When all in your country are having large families they can not afford, it burdens society to no end, as we have seen in other cultures.
In this sense society(the masses) need to take the lead, also local leaders. Try having 2 kids instead of 5 or 8. Myself nor many of my neighbors could afford more than 2 or 3 kids, it is just reality. Realizing this would help many in India along. This(having to many kids) only enlarges the welfare state. Having smaller familes will go a long way after a couple of generations.
The first thing India should do to evolve is make all equal, and ENFORCE the laws on equality. Each child born should have an equal shot(be identified!!) regardless of where they came from, or what job their parents have had. This will not happen anytime soon and India will remain in its sad state of affairs for quite sometime. They (higher caste,government,wealthy) will continue to hold the masses down, as their ambitions and aspirations override their morals, sense of duty and honor continually.
All the while acting pompous like they truly care about their people. I am not fooled as I watch and read people in India dying daily from a pure lack of morality, sacrifice, and service to the people.
So I will keep to my theme, that I have started long before this debate.
Hey India, EVOLVE ALREADY!!!
Poor safety record is not same as lynching.
India never had slavery.
India never invaded other countries to steal their oil !!
India never propped up dictators.
And yet india needs to evolve!! Who are you to tell India to evolve? A Tea Party Nut? I hope not.
Let me ask you this - why in 300 years a woman hasn't become a president yet? Why it took 300 years for a black to become a president?
Why do you keep talking about lynching?lol This was an insult to me and you expect me to respond to it as relevant? Your statement is nonsensical, as far as our conversation is concerned.
Now you call me a nut, you have called me racist. I believe you are wrong on both accounts.
Neither did we. Did you not loook into who recieved the most oil contracts in Iraq? Obviously not, or else your ignorance would have been abated.
India never propped up dictators
Why should they, they do a good enough job on their own people.
India never had slavery.
You are seriously misguided. There are numerous child slaves in India, Adults also to this day.
http://www.hrw.org/news/2003/01/23/child-slaves-abandoned-indias-silk-industry
Here is more.http://stopchildslavery.com/2008/09/10/the-railway-children-of-india/
And yet india needs to evolve!! Who are you to tell India to evolve? A Tea Party Nut? I hope not.
Yes India needs to evolve. I am a concerned citizen of the world who is tired of watching the rich and elite taking advantage of the masses . I am a human who has a good life going, but is concerned with the welfare of others as much as myself. I am omne who lays fact after fact of Indias abuses toward their society. My cause is just. That is who I am.
@ p.j;Here since you refuse to educate your self I will help you along. I will answer to your digression, takes less than a minute.lol
Read more: http://www.time.com/time/world/article/0,8599,1948787,00.html#ixzz1oXqIgFwN
Once again statement, source, see how that works.
Maybe because they never really tried up until the 90s? Maybe they were not the best for the job,or won the nomination. We have evolved, period. India is stuck in the mire, because of elitist.
LoL ....
Quote
Maybe because they (women) never really tried up until the 90s? Maybe they were not the best for the job,or won the nomination.
Unquote
That statement is a solid proof of how bigoted views you carry. Need I say something more?
It's a strange coincidence that you had to make that statement on International Women's Day.
For the record, India had a woman prime minister 40 years back. After that India has had many women serve as chief ministers, governors, top cabinet ministers, government officers and CEOs and much more.
Oh and I almost forgot - the current president is also a WOMAN and the head of ruling party is a WOMAN and that too an Italian by birth.
But those Elite Men from India - they are never going to share power with a woman, a dalit, a foreign born, a muslim - except for the recent history when they did it. That was really an exception. Now onwards they are going to stop EVOLVING.
We are not talking about equal rights for women, and my statement was fair, when did the first woman or black man try for the presidency? You are digressing from the original point the caste system still is alive and well in India,and they are suffering for it.
So they are the ones who could care less about their people, since you have so much opinion and not many facts, find one thing just one, either of these women have done for the lower caste, or show me where they volunteer their time for the poor and needy, or made sacrifice for their country. Just one.
Yes as you can see they are doing a wonderful job.lol. You just gloss over the fact of the child slaves, many catastrophes caused from corruption and bribes, crimes committed on those that delve outside of their caste. Digression is your game now that you have been schooled.
After I tell you how I think, and feel, you still call me a bigot? Your name calling is getting old. I am not a bigot, how do you figure I am a bigot, because I said maybe a woman never tried for the presidency until the 90s makes me a bigot?lol
Did women or black didn't try - or the environment didn't allow them to try? Think about it.
I am not interested in name calling. Your extreme comments are calling you out. I do not think Indians are free of Vices. I am not saying Caste system never existed in India. inspite of all of its shortcomings, Indian culture and civilization has been a centerpiece of world history and world civilization precisely because Indian culture and civilization has been continuously evolving. The very nature of Hindu religion is a testament to that where there is no one god, one book, one temple that dictates people. Buddhism Jainism rebelled against Vedic religion and all those 3 morphed into today's hinduism. That rebellion was against the very same people that you are calling "Elitist".
But you will conveniently ignore these things and ask India to Evolve. Interestingly you know how to choose your sources (i.e. blogs and newpaper articles) to support your views. So good luck to you. But your views are just that - your views. They dont define India and Indian culture.
@Ian
There is no slave system in the U.S. There was, but it was abolished in 1863.
I'm not sure I'd say the rich world thrives on these experiments. Could be many will die as a result of them, and not just Indians who participate in drug trials. The only ones to thrive are those who will profit from a drug later to be found dangerous.
All the more reason -- the other being cost, of course -- to depend on generics to the greatest extent possible. They've been on the market for years and the potential drawbacks are well-known. Ask your doctor if (the latest and most outrageously expensive drug) is right for you, as the ads tout? Not me. Indeed, I invariably ask if a generic is available if my doctor wants to prescribe a medication. So far, they have been and they have worked well.
Nathalie,
Good point, if a generic is available it lends credit to the safety and effectivness of the drug
Natalie and Ellis,
If there are already generics available, then this phase of testing was done long ago. The brand name drugs are not sold until this testing is completed. Generics are not released until the patents on the brand name drugs run out.
Yes, SingBiker is right. These products are in pre-approval and clinical trials. Generics are what force these higher prices when something comes to market. Pharmaceuticals are the only industry where when you invent something and patent it, someone else will get to make it in 15 years. They squeeze as much profit as they can in those 1st 15 yrs, before it goes to generics. What did the article say, each drug trial costs as much as 180 million in the US? Current statistics indicate that only about 30% of all products that go into trials get approved. That is a big price tag to try to cover.
Accidently ship them to Iran and Syria labeld for rebels; but make sure the terrorists get them. Make sure the rebels stay away from them. Label them as brain and muscle stimulants that will make the people stronger and smarter. Lots of test subjects that would overdose on them for free. Terrorists gone and wars over. Tests conducted (though not scientifically). Just a thought.
well that is one answer, do we hear any other suggestions from the board at this time? No?
I will blame the greedy American corporations to wanting to hire cheap labor and increase their profits. Why blame the Indians? Did they point a gun at you and tell you we want your jobs. It is these dirtbag CEO's after their bonus that are selling out our country.
That is what capitalism is all about - maximizing profits. How can you blame a system that has brought such incredible wealth and prosperity to you ? The problem lies with the current system in place that makes testing new drugs ridiculously expensive in the USA. Ultimately the drug companies offload all these costs on the consumers. As costs and approvals and licensing becomes costlier, the cost of drugs becomes costlier. If not India, these companies will ship this work to Africa or some other place.
The only solution is to improve regulations while maintaining the costs involved. The poor people in India get a lifeline and extra money, while US companies and Indian companies save and make money. It's a "win-win" for everybody in the short term and usually Indian companies that fudge the results would most likely have to shut down because a dangerous drug would cost US drug companies hundreds of millions in America. So capitalism will take care of "quality".
Why would a dangerous drug cost companies anything? Oh you mean after folks die they will quit buying it. Like folks quit buying liquor after a bad DUI wreck?
Companies will sell bad drugs knowing a certain percentage will die and it might be decades before it comes back to a company and then good luck in a court winning a case decades later.
You might mean the "government" will step in and fine the company? How is that capitalism?
Moving the drug testing to India will not affect the quality or safety of drug testing. I was hired to conduct drug tests at a major California campus. After three months it became obvious to me that the University depended on the huge sums of money that the drug companies gave to them. The chair and the IRB had little interest in how the studies were conducted and were not providing the oversight needed for the testing program. There was an enormous amount of pressure on the staff to show a positive outcome for each drug. The supervisor and staff who were doing the testing were being offered numerous "perks" to conduct the testing. The drug companies sent out their staff to monitor and coach the University staff to assure a good outcome for their studies. The testing area supervisor did not train her staff adequately and cross contamination and exposures to blood borne pathogens were always a looming problem. When I reported my findings to the supervisor, the University responded by black listed me. The University eventually settled with me after I filed a law suit but no one at the University was disciplined. The drug companies provide an invaluable service but the means used to test their new products should be evaluated by the FDA much more frequently and aggressively.
Ian-744285, if capitolism is such a great self-correcting system, then why do the law suits over pharmaceuticals go on and on? And many have nothing to thank the system of corporatism becoming common in the world and displacing the 'great capitolism'.
And WHT3 that has been the process in any type of court case for decades now, not just in pharmaceutical cases. It is the 'wait til they die game'.
Ian, our capital system is not sustainable. Our population is not out growing their 20% gain expectations. It can not continue to work (to current standards). The 1% is going to have to give up that 2nd bottle of $300 wine once a week...what a shame.
R Walker.
The capitalist system is the only system that is sustainable.
You may think you are entitled to everything that producing people get.
The producing people will go along for a while, then they will do the same thing you handouters do, sit down and put their hand out, or, they will give you the finger and go where they can keep what thy earn.
Since the beginning of recorded history handouters like you have tried to make some one pay their way.
The same things always happens, see Greece.
Whoa there nancy...you read an awful lot into that statement. I'm just pointing out that the powers that be are kicking a dead horse. Until the shareholders and their corporate masters give up the idea that anything less than 20% growth per year is not enough, the system isn't sustainable...sorry its just math. As far as you saying that I think that people are entitled to anything, I said nothing along those lines... Beside that the powers that be probably see greece as a bad investment. The US has far too much to loose to behave in the same manner that greece did.
When I was a student, I participated in medical studies. I did it to get money to boost my meager income (mainly student loan). I certainly did not get $150 per day; more like $25 per session. Which took like 2 to 4 hours. And I live in Canada. I don't think the studies were dangerous, but they were very unpleasant. After about 4 studies I quit because it wasn't worth it. I would never have participated if I had not needed money so badly. But really, somebody has to be a test subject. Best the money be paid to people who need it the most.
So apps having access to your photos on an iPhone is concern enough to get Google and Apple to answer questions, yet these drug companies don't have to answer to anyone on this? Oh wait... where are politicians getting their money? So there you have it!
And the FDA just accepts this, allows any fraud to be perpetrated on Americans who are paying top-dollar for drugs no one really knows are safe. Is there any part of the government not under corporate ownership?
....Of course they do. FDA is an American oversight committee. They don't monitor trials in other countries outside their jurisdiction.
If we cannot trust the pharma studies... how can we trust the drugs coming out of these studies? I am quite sure that the human guinea pigs are not ingesting the drugs when ever they can get away with it. The whole industry is a sham. I took vioxx for a while... and I am not happy about the situation. The alternative is much higher cost for medicine... let's just hope we can somehow clean up this mess so we can continue using the poor as lab rats.
When it comes to the big pharmaceutical companies, all who use pharmaceuticals are guinea pigs at some level. Big pharma's big money runs the regulators in the FDA, and many Americans are long-term psychotropic drug users - which goes a long way to explain the existence of the Republican Party and their current "mind-set."
The real problem is that the FDA is not doing its job.
this is the face of the REAL drug dealers in the world....far more people die from the side effects of pharmaceuticals than illegal drugs, but "legal" overdosing is ok as long as the pharm companies dont have to pay for it...people are animals
Many years ago Presidential candidate Ross Perot said if NAFTA was signed, we "would hear a sucking sound". And that sound would be jobs leaving the USA. Well, guess what? He was right.
Hey, I live in one of the worst places in the world in complete poverty. How about I have 4 kids, that should fix my situation or at least make it a little better.
Pharmaceutical predators praying on the poor and defenseless; I hope you all rot in hell.
you think those american pharma companys care about human life ??? its about money - thats ALL !!!!!!!
stop pumping out kids u can't handle & keep the legs closed. too many people in this world.
exaactly. once someone reproduces they have no right to complain about anything, they are responsible for their own problems, their kids problems, and they just burdened everyone else on the planet.
Yeah, they did studies here on syphlis. Tuskeegee, Negroes I believe.
Note to Sonya Jones... That was a brain fart you had, not a thought. Why bother to make a comment on something so serious and troubling, with an irresponsible and hateful statement?
This is very much like Tuskeegee... again "people who don't count".
And it's white Americans, who can afford the drugs, who will benefit. BTW-I'm white and have no health insurance. I am employed and have a degree as well as 20+ years work experience. Go figure that!
How many commercials nightly appeal to you to tell your doctor that Cialis is best for you?
As much as we hate violence things like this makes you want to do something really wrong does'nt it. Millionairs using poorest of desperate people to test drugs on to save 'money'. american corporations you gotta luv'em.
This is very insidious, and it is just a sign of our times that some shrug it off with a 'someone is needed for research, atleast they are paid!'?
Totally inhuman, machiavelic and all about superlative greed !!!
I do not know how the Indian government allows this---unless the corrupt Indian politicians are getting paid to turn the face. There is a business Corruption Act by the USA and deals with huge penalties over commercial "contract" matters--how in the world can this be overlooked--ee are dealing with human lives here! These Pharma's are wicked and evil ---and it all goes back to money and DC politics--all of it!
It's ok. They are earning money and cute little furry rats, dogs, monkeys, all so precious are spared. How about using death row prisoners? I forgot to mention the bunnies, so cute and cuddly, spared also.
Don't test in India. Go the Watts section of LA.
I used to wonder why branded drugs are always first available in poor southeast asian countries for consumption years before they FDA approve them for the US market. Now I know.