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Subscribe to RSSSome 211 people died during clinical trials for new drugs in just six months in India, an official reportedly said.
The Times of India newspaper said investigations were underway to see how many of the deaths were caused by the drugs or by diseases affecting the trial subjects, such as cancer.
The Times said that in 2011 some 438 cases of serious adverse events were reported, with 16 later found to be due to clinical drugs trials.
India’s Central Drugs Standard Control Organization has now proposed ways to reduce the number of problems and a new formula for compensation, the paper reported.
Compensation is currently decided “according to the will” of the drug company, the Times added. Previous compensation payments of families of people who died during trials amounted to just a few dollars.
"When a 70-year-old patient who is terminally ill dies during a clinical trial due to an adverse reaction of the drug, the compensation should be less than that given to a 22-year-old man in the first stage of the same disease who dies of the same drug," a CDSCO official told the paper.
"The youth could be the sole bread-winner of the family and would have lived longer but for the adverse drug reaction. So, the guidelines quantify accordingly who should get how much compensation. At present, both could get the same amount and it could be abysmally low if decided by the pharmaceutical company,” the official added.
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Well, this one wont be worrying about cancer any more...
Next.
Oh Muzzy, pot is for recreation only. It cant possibly have any good attributes they might have to decriminalize it and then start using it to treat the many ailments it could fix. Its bad, just plain bad I tell you. (sarcasm off)
Yea they should allow its use for so many reasons, but too many ding dongs think it should be a controlled substance. It would help so many people in so many ways if the gov would back down like they did with alcohol. If anything should be a controlled substance it should be alcohol, not pot.
To Rah13:
The customer reps you talk to on the phone are only doing their jobs---you can't blame them for that! The number of jobs that went to India is quite small---a couple thousand---whereas, the number of jobs that went to China numbers in the millions. You can't compare. However, India is now open to American companies who want to sell their goods over there. Remember, it is a huge market.
This might be just a little bigger than you think it is, as call center jobs once represented about 3% of our job base. India alone has more than a third of a million people employed doing phone center service for Americans. Strangely enough, the Philippines employs more- about 350,000 total at last tally.
Yes, manufacturing represents a bigger demographic- and it's fair to say millions lost their jobs over offshoring, and we need to change the conditions which currently prevail: it's profitable to screw the middle class as things now stand, even though it's slow suicide for American businesses busy killing their customer base. The big problem is the fact that the right has staunchly resisted any efforts to reduce federal benefits for companies engaging in the destruction of the domestic job base- let alone levying any additional taxation on them.
Regardless- life is cheap there- and people are just another expendable as far as many companies are concerned. Look at the compensation rate for the village killed by Union Carbide (now part of Dow, which has very similar policies) and you'll see a trend. This is why companies and politics should never be allowed to mix- and why the Republican party's take on politics is so very, very bad for the majority. Want to live in India- right here in America? Vote Romney/Ryan....
I personally hate talking to customer reps in India, who represent that first line of contact by American companies, from the same town/state that I live in!
The evidence seems to be clear from this incident; why in the world would I buy products "made in India," if I had the choice? I'll add China to that list also!
If you buy generic meds, many are made in India. Dr. Reddy FTW!
Rah - I think that you are missing that global companies also do clinical trials in India. So adding India to your list really doesn't make a lot of sense.
The key is ...having a choice.
Rah123...why don't you also shed clothes since they are made in China / Guatemala /
Bangladesh / Egypt ? Why not discard all your furniture since they are pretty much
all Made in China ? Also stop mowing your lawn and throwing mulch since its
Jose and Diego from El Salvador doing it ?
Alter your ears and listening skills and suck it up. Your "born in USA" kids are too
good to do all this....they would much rather finger point, claim how they are the best
because they are "white" and suck up welfare...
Don't be silly. Indians are the nicest people in the world.
The article fail to mention the name of the drug company who conducted the drug trials. I think it very critical to know the who is behind the death of so many people and the under compensations of those deaths because of the rush to make money.
Take your pick and pick the week. All of them!
I would bet they are American companies. Preying on the poor, no wonder we are hated.
@aswestand - If you read the original (not rewritten by NBCNews) you will find this:
So, it's not really surprising that MAJOR US & European drug giants try drug trials in countries that don't have "informed consent" laws. Oh, and if someone in India dies, well, they don't have to pay as much for that life. Now they will tweek the drug, test in Africa, etc... and when they figure out how to manipulate the death statistics, they will get it pushed through the FDA in a heartbeat.
These drugs are made in US and EU labs, not India, they only "test" the drugs on people in India - probably the poorest people. What's up next - a new "Bextra" or another "Phen-Fen?" We won't know about the India "trials by death" when the drug hits the US market - that's why they aren't naming the product yet....
It really is sad when you but a price on a life as standard operating procedure....
Yes, I too thought all the trials were done in Africa. But there are a lot of poor/uneducated people in India to take advantage of, also.
Very sad, but people with terminal illnesses have little hope and can be swayed by the possibility of a "miracle cure", and will take part in such trials. The only reason why we hear about such trail deaths in countries like India is not because people in the US are more astute or cautious, but because US regulations and the legal system would make it very difficult and costly for drug manufacturers to pursue.
CEO's like corporations are people who have bought themselves a lot of tax loopholes. the right to exploit other countries and the support of the US military in their imperialistic enterprizes. They know how to play the game because they had part through their money to help write the rules. It's not about getting a free ride it's about making people pay their fair share, getting rid of slave labor and unrestricted working standards, that poison the land, create unsafe working environments and unsafe products. It's about getting your leaders to serve the nation and it's people and getting rid of the sellouts so that we can have a country by the people for the people.We the People of The United States are no better then Penn State, because we refuse to accept what is really going on in this country and how both major parties are involved. The world anymore is now controlled by industrialized elitist that only care about profit not who lives or dies. The US goes on with it's own agenda and keeps it's people well divided and conquered. The USA is burning while the career politicians serve their special interest masters,it doesn't matter who gets in as long as big money decides both parties. I'm going to keep voting every incumbent out and for as many independents as I can. If everyone did that it wouldn't change the government in one election but it would sure shake them up to realize that if they do not start serving the people over big money contributions they will be finding temporary employment.The only thing that is going to save the country is putting the pressure on government to to serve the people rather then their own self interests.
AMEN! Absolutely true. I would be great if you r idea would work, except that these so called "voter I.D. Laws" are designed to prevent anyone who does not agree with the rich from voting. We have a government of the RICH, for the RICH and by the RICH.
@Black Kettle & Sand Creek: You obviously do not work in the pharmaceutical industry or you would know that India does have a regulatory authority with established guidelines similar to those of the FDA and EMEA. India has local independent ethics committees that review the trials. The sites are monitored by the pharmaceutical companies, Additionally, the sites may be audited by the Indian regulatory authority and the major regulatory authorities, such as FDA, to whom the clinical trial is registered. That is not to say that fraud (data) or coercion of the subject to enter a trial will not occur at the clinical site level. In my experience that does not happen that often and a site (doctor/nurse) doing such is typically found out and disbarred.
I find it insulting that seemingly educated Americans would still have the idea that the pharmaceutical industry are a bunch of pirrhanas. You would not believe the depth to which we have to go to ensure a clinical trial is being conducted ethically.
As for the number of deaths increasing, it's entirely possible that is influenced by number/size of trials being conducted in the country and the disease states. What if the number of subjects on trials for blood thinner (next-gen Plavix) had increased? The patients who would be in such a trial are typically 50+. There would be a higher incidence of death due to disease in such trials. Not to mention that all deaths must be reported, whether or not the death is related to taking study drug. Even a patient who dies in a car wreck or from cancer must be reported.
I see this news story as a bit of sensationalism; no compelling evidence is presented to prove it is truly a negative trend.
What I fail to understand is why they have no toilet paper in India.
George: Hell they don't have any toilets in India...They @!$%# in the fields and rivers...That of Epic world wide plague comming.
I certainly hope the US NEVER imports any prescription medicine from India. India, by the way, is one of the world's largest suppliers of ephedrine to Mexico, where it is sold to drug cartels in Colombia and Peru to make methamphetamine. The yearly shipments are in TONS of ephedrine and cannot be tracked once it is off the boat in Mexico. The other main supplier is China. Do you trust your crack dealer to sell you a quality product? Ask him if the ingredients come from India or China.
If you are taking any generic prescription drugs, rest assured that they are probably coming from India.
Yep.. trust me, you've already consumed medication from India. And somebody probably died to produce 'em.
At least they didn't suffer from anal leakage..
Seriously though, "When a 70-year-old patient who is terminally ill dies during a clinical trial due to an adverse reaction of the drug, the compensation should be less than that given to a 22-year-old man in the first stage of the same disease who dies of the same drug," a CDSCO official told the paper.
Does anyone else have a problem with this?
I think we shouldn't judge the age/ quality of people's lives when it comes to a settlement; whether a person is 8 or 80, and they died, the compensation should be the same- compensation should be based on NEGLIGENCE, not based on how soon the person is going to die.
To Mathuin:
Indian pharmaceutical companies have high standards ---moreover, there are surprise, unannounced inspections by the US regulatory agencies and European regulatory agencies.
Moreover, Indians have a conscience ..... unlike some others, I will not name.....
Free Market, Baby!
If we would just let the Pharmaceutical companies work with the Invisible Hand of the Free Market, I'm sure everything would turn out just fine.
It's all about Deregulation, Tax Cuts, and getting out of the way of those Job Creators.
This is just what the India government reports. They have no regulatory agency like the FDA that monitors the trials, which is why they have moved trials overseas. They take people out of the slums by promising them money and bury all of their mistakes for a few bucks. The government gets big money and with phoney results thet get the drugs approved in the US. Each big Pharma has a number already set to cover the deaths that arise in the US by putting putting unsafe products on the market while they are still adjusting it overseas. They end up redesigning the product and maybe by the second or third version is it actually safe for the public. This has been going on for years in countires all over the world. Where do you think the AIDS drugs have been tested?
This is just not true. Any clinical trial run by any company seeking FDA approval for sale in the United States is heavily monitored by the FDA regardless of where the trial is being run.
published by the American Medical Association...
ama-assn.org/amednews/2010/07/19/prsc0719.htm
John .. what if they run their trials first THEN seek FDA approval? No oversight until the drug company knows what kind of results they'll get.
RIposter:
Are you implying that the Invisible Hand of the Free Market, which belongs to Job Creators, needs the interference of Big Guvment? Do you not realize what blasphemy that is? EVERYONE knows that if we just leave the Job Creators alone, they'll fix everything and everything will be just fine.
You know what I think? That if we got rid of the FDA then the Drug Companies - instead of off-shoring drug trials - would be content to experiment on Americans instead of foreigners, thereby creating jobs and opportunity for all!
/snark
If someone kills a 70 year old do they get less jail time than if they kill a 20 year old?
It doesn't mean that Indians don't value their elders. Living in an affluent country allows you to sneer at that statement. Despite its limited economic success the vast majority of Indians are extremely poor and live in terrible conditions. Having a bread winner who is young and healthy is a reality whose significance you will never understand, and I hope that it will never become a reality here.
211 die in India.
Just pile the corpses over there, yeah, there, next to the other pile of bodies along side the road.
Now, it's time to go worship some cows, and time to feed the rats.
Not too different from eating cows, pigs, slaughtering the same cow that is first fed, and worshipping some Arab / Palestinian guy who walked on water ( yeah, right ! ) and then hating Arabs later...
Ever since the FDA Modernization Act of 1996??; fast track new meds approvals, big Pharma has been allowed to use evidence of drug studies conducted in other countries and reported in less well-known medical journals the trend is to outsource Phase III Clinical Trials. It's cheaper and there is less oversight. Sounds like the good ole American way, exploit a market to the fullest.
In countries where poverty is the norm, the few dollars offered must seem like a fortune. As the de-regulators get their way, we'll have even more of this so newer biologicals can be rushed to market. The market for what's known as "specialty pharmacy" is enormous as there are hundreds of new drugs in the pipeline and big Pharma is already counting its filthy lucre!
There is so little oversight by the FDA. It's a joke they don't even do their jobs in the US. Do you really think they would do their job overseas. They are bought and paid for by Pharma I for one avoid all pharmaceuticals unless it's life threatening. You can't count on the government to protect us it's an illusion.
What's the matter with you? Genetically altered foods will actually help extend the life expectancy of the average American Citizen to a healthy 146 years of age. Just ask the political appointees at our Food and Drug Administration.
To get the same amount of nutrition that was supplied by one apple eaten in 1956, you have to eat six (6) of today's apples. That should tell you something.
Hmm these deaths couldnt possibly be attributed to corporate greed trumping medical care could it???? How could anyone have the audacity to make such a claim?
The population of India is 1.22 billion people, and is it one of the reasons the drug companies would like to choose them as the target of the trials of various kinds of drugs?
The India government should not allow any drug companies to do it, and they need to review the data for the successful testing results on animals.
What do you expect from people who think it's good luck and a blessing to have a cow crap on the floor of their house?
You are ridiculous. Why don't you get out from your parent's basement, and see the world???
If you ever go to India, you will see that middle -class Indians are exactly the same as middle-class Americans. Let me describe my cousin's house: Sparkling clean granite and mosaic floors, granite countertops, Western-type bathrooms and fixtures, and minimalist furniture.
The only difference is that Indian kids respect their parents and take care of them in their old age, instead of shoving them in nursing homes.
why dont they talk about the company or what drug they were testing? instead they just talk about comensation and how young victims should get more than old victims? each family should get at least a million bucks? if a lady can get 2 million for spilling coffee on herself you think these people could get at least half of that.
You're kidding. They got pennies per dead for Bhophal, and the US won't even extradite those responsible, who have outstanding Indian warrants outstanding on 'em.
@CaliforniaFirst - what the *&!# are you talking about? There is nothing in the India Times news report that states the Indian government has charged anyone.
For all of you who think that the number of deaths is alarming - you should understand that the vast majority of the deaths are probably due to either an unrelated disease, progression of the disease the subject is being treated for, say cancer, or even accidental death. Death of a subject, no matter the cause, has to be reported.
Last spring, the Business Standard had a news story that stated there were 671 reported deaths in 2010 amongst subjects in clinical trials. If you Google, you can find news stories almost every year for the last 5 years, all saying similar things. The problem is, the number of deaths is relevant to the number of subjects in trials. As the number of subjects increases, the number of deaths reported will increase. And remember, a death, no matter the cause, must be reported. What would be important is if there was an increase in the number of deaths directly caused by the investigational drug or device. There have been no news articles stating this is the case.
TrickleUp, if you read what I wrote carefully, I was referring to Bhophal, the Union Carbide disaster 20 years ago.. 3,000 dead instantly and 10,000 more over time in a methyl-isocyanide leak at a chemical plant. India brought criminal charges against UC execs (now Dow Chemical) but the US prevented their enforcement. I was not referring to the current scandal.. just to say that there is a history of US corporate impunity in India.
The tsunami of medi/pharma nonsense in this country is enough to drive a person to hide in the Black Hills of Dakota. Everywhere I turn someone is shovelling down pills. 1 friend takes 200 a day! WTF? In movies, the guy/gal gets up and downs a fistful, no explanation as if it's as normal as brushing teeth. The social medical system in UK persuaded my sister she needs 20 a day for blood pressure, anxiety, twitching eyelid, noisy poop, rebellious pee, talking toenail, hell I don't know what they convinced her was life-threatening. I managed to talk her down to 10, and she says she feels better and will continue to reduce. She says she has to lie to the doctor about taking them all.
Jeepers. We are a bunch of mamby-pambies. When did we turn from trail-blazing rugged pioneers to babies being bounced on the knees of the true drug lords?
India will export about $75 billion in pharma back the west by 2020. Pfizer, GSK and Novartis are among the pharma majors that develop and manufacture there. This rot goes right back to the our own countries - both our medicine cabinets and our corporate boardrooms.
This is the vision for the future of the India being promoted by our corporate oligarchies: open for exploitation, in a way they never managed to figure out how to do in China.
You complain about tests being done in India? Thank the US Lawyers. Thank the FDA. Drug companies do much more good than harm. I know it seems like they make millions. How many of you know somebody who works for a Drug Manufacture? You have know idea the amount of paper work, testing, quality control that goes into a drug that can be prescribed to you. The FDA paper work and inspections is mind numbing. If you or one of your loved ones is saved by just one of the hundreds of medications out there, you might just sing a different tune. What's sad is many of you probably already have. How do you folks recommend drugs be tested? The US use to allow more clinical trials for the terminally ill until the Lawyers convinced Family survivors that they had been murdered. The only ones that end up with money is the Lawyers. Now the damn lawyers sit on both sides. It's become a stalemate. So any suggestions? Or should we stop making all medications including insulin, asthma, heart and blood pressure medications? Antibiotics, anesthesia? Do you want to see one of your loved ones needing emergency surgery without anesthesia only to die from infection due to lack of antibiotics?
To LiitlI56
I say we test the drugs on the US Lawyers then they can sue the drug companies for wrongful death. Oh, wait a minute I guess they won't be at the trial. What a shame!
Years ago, when birth control pills first hit the market, I questioned the wisdom of adding hormones to the human body. After doing some research, I realized that we have very little real knowledge of how hormones interact, nor do we understand all of the things that hormones do. We only know the more obvious hormonal effects. So I decided to skip the hormones and use alternative forms of birth control. They worked just fine and I didn't have to worry about blood clots or strokes or any of those other piddling little complications.
They also came up with hormone replacement therapy for menopause. How did women ever get through menopause for the past thousands of years without HRT? Now it turns out that HRT may contribute to breast cancer, but not to worry, just don't use it for too long. Maybe you won't get breast cancer, and if you do we have all these wonderful chemotherapies for you. Did you know that chemo kills a whole lot of cancer patients? so we have another pill that may or may not be good for you, but certainly has some pretty serious side effects.
Have you watched those ads on television, where they introduce some new drug to treat something people have lived with for centuries, but now they are told they need a pill to eliminate the problem? Then you hear all the side effects and you really have to wonder if the risk is worth the reward.
I'm not anti-drug. Drugs can save your life. But I am against creating a drug with potentially lethal side effects to treat a minor disorder that you can live with quite easily. We've been brainwashed into believing that you need a pill for everything. Do you really?
Living standards in India are lower than in the West, thus pharmaceutical companies are properly compensating test subjects for trials that go wrong (and, according to the article, in accordance with the Indian government's expectations). The article states that the figures aren't conclusive since many trials involved individuals who were already terminally ill. Chris Hansen (of To Catch a Predator fame) did a hidden camera sting operation inside of India and exposed the Indian companies that run these clinical trials for the pharmaceutical companies. He was nearly assaulted when he confronted the Indian executives.
It's much easier to blame those evil westerners than it is to put blame on a society that still practices modern-day slavery. Btw, the Bhopal disaster was entirely run and managed by Indian nationals. The company involved was the Indian subsidiary of a multi-national corporation and the Indian public owned 50%. The people impacted by that disaster were paid pennies on the dollar by the Indian government.
Wow. I just completed the National Institutes of Health "Protecting Human Research Participants" training last night! I wonder what agency or body governs the drug trials in India. It is certainly doing a horrible job.
Check out the US standards at http://phrp.nihtraining.com/users/login.php?l=3
Now here is a teachable moment. Here in the US we have very strict guidelines about this and those that are running against the current administration want to do away with these cumbersome requirements. This is called letting the business community shed the shackles of oversight and un-necessary guidelines and requirements. Think carefully before you allow this to occur.
The population of India is 1.22 billion people, and is it one of the reasons. the drug companies would like to choose them as the target of the trials of various kinds of drugs?
Big Pharma. phuckin with "HUMAN LIFE" its what they DO! .... Safe or not , "we'll kill ya"!
And smokin a joints bad ? how again ?