Over 2,600 'Human Guinea Pigs' May Have Died From Pharmaceutical Trials in India

[Judi Lynn]

Source: Times of India

Published on Thursday, April 25, 2013 by Common Dreams

Over 2,600 'Human Guinea Pigs' May Have Died From Pharmaceutical Trials in India

Times of India reports on high cost of foreign pharmaceutical firms' drug trials in India

- Common Dreams staff

As many as 2,600 "human guinea pigs" died in the past seven years during drug trials by foreign pharmaceutical corporations, The Times of India reports on Thursday.

Trials for two drugs by pharma giants Bayer and Novartis "accounted for maximum number of deaths," they report.

"Serious adverse events of deaths during the clinical trials during the said period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials," health secretary Keshav Desiraju said in an affidavit on behalf of the ministry of health and family welfare.

"Around 11,972 serious adverse events (excluding death) were reported during the period from January 1, 2005 to June 30, 2012, out of which 506 events were found to be related to clinical trials," he added.

According to the paper, trials of 475 drugs took place but only 17 of them were approved for marketing in India.


Read more: http://www.commondreams.org/headline/2013/04/25-6

---

(Short article, no more at link.)

"This work is licensed under a Creative Commons Attribution-Share Alike 3.0 License"

[cosmicone]

1. Another polyannish organization desperate for ratings...

The article doesn't provide a denominator to assess the percentage of patients who had the adverse events and whether they occurred in both groups (i.e. Test article and placebo.)

Patients in clinical trials are volunteers and not forcibly rounded up. They all have to execute a written informed consent after a 3 day cool-off period where they can seek the advise of people unrelated to the study. and are compensated for their participation. They are hardly guinea-pigs but by using that inflammatory term, commondreams wants to get publicity and donations. Despicable.

[dixiegrrrrl]

2. You are certain that all the study patients in India

were given the opportunity "to execute a written informed consent after a 3 day cool-off period where they can seek the advise of people unrelated to the study."?

I ask because according to the British Independent:
Illiterate patients say they never agreed to take part in trials run by industry worth £189m

activists say a lack of oversight has led to numerous situations where poor, sometimes illiterate individuals, recruited from city slums or else tribal communities, are used in the trials without giving proper informed consent –
that is, without fully understanding what they are signing up for.
Alongside this, a new industry providing participants for these studies has been spawned and is making considerable profits.

and
Specifically there are these examples:

* The recruitment of hundreds of tribal girls without parental consent for an immunisation study sponsored by the Bill and Melinda Gates Foundation on the nod of the warden of their government hostel. Several girls subsequently died. The study was halted by the federal authorities.

* The use by drug companies of survivors of the world's worst poisonous gas disaster in Bhopal as "guinea pigs" in at least 11 trials without proper informed consent.

* The completion by doctors at a government hospital in Indore, in central India, of dozens of private trials that a police investigation found "violated the ethical guidelines". The doctors who conducted the trials decided that not one of 81 cases in which a participant suffered an adverse effect was linked to the treatment. New trials were stopped while the state government investigated. A whistle-blower was fired.

http://www.independent.co.uk/news/world/asia/without-consent-how-drugs-companies-exploit-indian-guinea-pigs-6261919.html

AND
the author of The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects
also seems to think there are some problems.
http://www.amazon.com/Professional-Guinea-Pig-Pharma-Subjects/dp/0822348233

your definitive certainty seems unwarranted.

[cosmicone]

4. The time specified was after 2005

bringing up stuff from the 50's and 60's is not relevant.

Also, when there is money to be made, people will claim anything. In Philadelphia, an empty bus going to a depot had an accident which was reported on the radio and within the next hour, some 16 people showed up at various ERs claiming that they were on that bus and got hurt!

[TheMadMonk]

5. Is that ignorance natural or cultivated?

That "Stuff" referenced was all from the 80s to present.

That "Stuff" is relevant to people alive right now, and also apparently to people who bloody well should still be alive right now.

[cosmicone]

6. What has that got to do with the story which specified 2005 and later? n/t

[TheMadMonk]

8. How about the simple fact: IT HASN'T FUCKING STOPPED HAPPENNING.

Pharma, just goes out and find different poor and poorly educated test subjects somewhere else, when efforts are made to enforce ethical standards.

[HiPointDem]

23. "India relaxed its laws governing drugs trials in 2005"

[cosmicone]

27. The only thing they relaxed was

allowing Phase I trials (first in man trials) of drugs and biologicals developed outside India.

[HiPointDem]

29. lol.

[HiPointDem]

17. garbage.

[Warpy]

11. This article is ridiculously incomplete

and hysterical in tone, the raw number of deaths in the headline giving way to a grand total of 80 deaths from the trials, themselves. It doesn't state how many people in total were involved in these studies, how voluntary they were, how the people were informed about the possibility of illness, disability or death, and whether or not there was a cluster of deaths/adverse events in one or more trials and whether those trials were suspended immediately, as they would have been in the US.

It's an irresponsible article that gives little useful data.

[cosmicone]

22. +1000

My points exactly.

It was just a publicity stunt by a desperate goody-two-shoes website looking for attention and donations.

[nomorenomore08]

40. You make some very valid points here. But I think the existence of shady goings-on

is pretty much indisputable. And although you're being perfectly reasonable, I don't know what that other poster is so damn angry about.

[Wilms]

9. Try this link that was embedded on the OP link.

2,644 died during clinical trial of drugs in 7 years: Govt to SC
Dhananjay Mahapatra, TNN | Apr 25, 2013, 09.13 AM IST

http://timesofindia.indiatimes.com/india/2644-died-during-clinical-trial-of-drugs-in-7-years-Govt-to-SC/articleshow/19719175.cms

[closeupready]

24. You WOULD say that.

[Zoeisright]

31. Bull. SHIT.

Drug companies are taking their research out of the U.S. simply because regulations in other countries are much more lax. In addition, informed consent in those countries is questionable. Many times the "guinea pigs" are not literate and do not understand what is being done to them.

Christ on a crutch, the stupid.

[cosmicone]

32. Have you ever been involved with designing and implementing

a clinical trial anywhere?

Otherwise it is just a chauvinistic statement that "other countries" are lawless and not as "good" as the US or EU.

I have personal experience running trials in various countries and no major pharmaceutical company would do a clinical trial except under strict ICH/GCP guidelines and monitoring.

A lot of the under the table trials are done by wannabes -- like doctors themselves or small operators who want to try out something but lack the resources to do it right.

Data from non ICH/GCP trials is not accepted by most regulatory bodies such as the FDA so it is worthless for a real pharmaceutical company.

Study this instead of having a knee-jerk reaction.

[nomorenomore08]

39. Why are you so vehement about this anyway?

All your posts on the thread seem unnecessarily aggressive. Almost as though you had a personal stake in things.

[neversaydie]

42. hmmmmm.

I wonder.... I just picked up three books related to this: Unhinged, Anatomy of an Epidemic, and Pharmaggedon. Real eye-openers on what constitutes a drug trial and how Pharma gets their drugs to market. Who regulates this stuff (excuse if that's a dumb question).

[nomorenomore08]

44. "Who regulates this stuff"? In some cases, basically no one.

Sadly, the shady doings described in the OP don't really surprise me.

[neversaydie]

45. and it's not just the trials

to get the drugs to market. Many of the drugs that are approved are used on patients - more guinea pigs. My daughter is suffering from strong muscle contractions and pain, something called tardive dystonia. Neurologist diagnosed it as an after-effect of one a newer drug that she was prescribed.

[nomorenomore08]

46. I've heard of that (also called tardive dyskinesia).

An unfortunate, and common, side effect of anti-psychotic drugs.

[neversaydie]

47. was new to me

it was explained to me that the difference between tardive dystonia and tardive dyskinesia is that the latter is involuntary. I'm still learning as much as I can about it.

[nomorenomore08]

48. Either way I'm sorry to hear about that.

IIRC the condition can sometimes be partially reversed, if the medication is reduced or stopped.

[arikara]

58. Read this article by Vanity Fair then repeat that nonsense

http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101

Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves? The authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in a lethal profit machine.

[Sunlei]

3. most childrens drugs too and they never submit the failure tests.

[Jake Izzy]

7. Unbelievable

the families of victims will probably not even be compensated.

[rexcat]

10. The article...

does not go into enough depth to make any rational conclusions. What types of clinical trials (oncology, cardiac, urological, women's health, endocrinology, etc.), what phase were the clinical trials and what were the specific relationship to the serious adverse events and deaths to the study drugs being tested. Without this basic information any conclusions made are purely speculative.

In oncology studies one can see multiple serious adverse events with each subject in the trial. Death is not that uncommon in oncology trials. Same can be said of some types of cardiac trials. If they saw deaths in pain studies, contraceptive studies or vaccine studies there might be a problem.

"Around 11,972 serious adverse events (excluding death) were reported during the period from January 1, 2005 to June 30, 2012, out of which 506 events were found to be related to clinical trials," he added.

The article does not give the total number of subjects in clinical trials in the date range given or the type of studies where the serious adverse events were noted nor the relationship of the serious adverse events to the study drugs being tested. Anyone who would make a conclusion on this information has no understanding of science or statistics. Science illiteracy is rampant in this country and it seems to have a hold on some here on DU.

[TheMadMonk]

12. Whoosh. Point was not the outcome (or even aim) of the trials.

Point was how those trials were carried out. And how test subjects were "recruited".

Prisoners given no choice at all, or offered inducements that would be minor to you and I, but are huge to someone on 23/7 lockdown. Even the simple opportunity to get out of their cell for an extra hour or 2 a month would be a huge incentive.

People already vitimised by the Bhopal chemical disaster.

The desperately poor, and the poorly educated all around the world, but particularly in third world nations.

THE ACTIVE SELECTION OF PEOPLE UNABLE TO GIVE FREE AND INFORMED CONSENT!

The active selection of people without the wherewithall to seek redress if a drug proves to be dangerous.

[rexcat]

13. Sorry but the discussion about informed consent...

had nothing to do about the OP. The link in the OP had to do with number of deaths from 2005 to 2013 in clinical trials in India. There was a link downstream by Dixiegrrrl that had to do with informed consent. That is a whole other debate as it relates to the original link in the original post.

For full disclosure I work in the Pharmaceutical Industry in clinical trials. Since the pharmaceutical companies have been placing trials in developing countries I have been uncomfortable with that scenario. The overall population in developing countries are typically poor and undereducated and should be considered vulnerable per the FDA and US regulations. If a pharmaceutical company is doing a clinical trial under a Investigational New Drug application anywhere in the world then US regulations come into play under 21CFR 50, 54, 312, 812 and several other regulations that I can't remember off the top of my head. Prisoners, unless under very special circumstances should never be used in clinical trials. That goes against the Nuremburg Code, the Acts of Helsinki, the UN conventions and our federal laws. These issues were also nicely laid out in the Belmont Report in 1979.

Considering the issues we have in this country with informed consent with our undereducated population, the developing countries are the ultimate nightmare. Unfortunately there will always be hazards when new molecules are being tested in human populations. The informed consent process tries to alleviate some of the hazards but shit still happens. There appears to be issues in India when it comes to informed consent. That is not exactly a secret in the industry. The pharmaceutical companies do try to mitigate it as best they can but they could do a much better job. Could it be possible that the Indian government might be part of the problem. Are they not enforcing International Committee on Harmonization and Good Clinical Practices (ICH/GCP) guidelines and/or are they also ignoring their own laws or are their laws too lax? My guess is all the above. Unfortunately in developing countries the clinical trials are handed over to India based Contract Research Organizations and some maybe less than scrupulous.

This is a very complicated ethical issue that is discussed at professional meetings within the pharmaceutical industry (ACRP, DIA, etc.) and within the pharmaceutical companies themselves. There are no easy answers but it sure easy to armchair quarterback on this, especially when one is uninformed of the real issues. It is also easy to lump these issues with the Bhopal chemical disaster but that, IMO, is a cheap shot.

[TheMadMonk]

15. Would those discussions be like the LIBOR and Municipal bond discussions?

Who was it that got busted burying SERIOUSLY negative clinical data on Vioxx?

Who routinely cherry picks trial outcomes for data to suport a desired conclusion?

Who pays manufacturers of generics to not compete?

Who charges many times the price in America that they charge in other COMPARABLE markets for identical products?


And you still missed the point. (Alteranately it's a deliberate misrepresentation.)

Did not lump with Bhobal disasater. Said the victims of that disaster have been exploited SINCE the disaster.

[rexcat]

34. No they are not like LIBOR or Municipal bond discussion...

May I suggest you never take any prescription drugs for anything because it is obvious to you that all clinical trials have been conducted are fraudulent. On the other hand I would love to see you on a drug that I have worked on!

I would like to address on comment you made

Who charges many times the price in America that they charge in other COMPARABLE markets for identical products?

What other markets are comparable to the US market in pharmaceuticals? I don't think it is Europe since health care is socialized and the government pays for the drugs. It is not Australia or Japan since they are like Europe. What markets are you referring to? Russia? India?

Obviously talking to you about the issues in the pharmaceutical industry would be useless since it is obvious you have already made up your mind. You have a lot in common with the majority of residents in the community I live in. Closed minded!

Thanks for the insult. What specifically did I deliberately misrepresent? It is easy to make accusations without facts.

And you still missed the point. (Alteranately (sic) it's a deliberate misrepresentation.)

And talk about misrepresentation

Did not lump with Bhobal (sic) disasater (sic). Said the victims of that disaster have been exploited SINCE the disaster.

You sure seemed to imply it!

I have always stated that there are issues in the pharmaceutical industry when I see posts like this. You do seem to be the typical anti-Pharma type of DU. Quick to express an opinion not based on fact.

By the way your spelling is really something!

On edit: you did not counter anything I said in the post you responded to because you really are uninformed on this topic!

[TheMadMonk]

49. And what specific drug might that be?

Given the snark, I'm sure it's something absolutely delightful.

Comparable how?

Comparable in terms of the WHOLESALE prices of the drugs.


The discussion about informed consent has a great deal to do with the OP, even if it is not mentioned in the OP. Drug companies are all too often choosing to run trials where the test subjects do not even have the beginnings of the knowledge necessary to make informed consent, AND where they are under no obligation to ensure the subject demonstrate such knowledge.

The available evidence says, drug companies are location shopping and running trials in a manner which would often be illegal in the nations where those drugs are intended to be marketed.

THAT IS THE POINT YOU ARE PERSISTENTLY MISSING. Whatever personal concerns you choose to express.

Bhopal:

My exact words: "People already victimized by the Bhopal chemical disaster."

I don't see how that can possibly be interpreted as anything but past tense. As in PRIOR to the events (drug trials) currently under discussion.

YOU are the one who conflated current concerns with a thirty year old disaster and then claimed it was my doing. Your's is the cheap shot.

But please do allow me to lump them both together. India is chosen for drug trials today, for the same reason UC chose India to erect a chemical plant which would have been non-compliant with regulations anywhere in the West. Fewer pesky profit sapping regulations and greater opportunity to externalise costs.


AS A MATTER OF FACT I have defended the pharmaceutical industry, cops, and many other favourite DU whipping boys on a number of occasions, when the circumstances warranted it. AND put the boot to things I generally advocate in favour of, when I've been confronted with reason to do so there.

I have no issue whatsoever with the service provided by pharmaceutical companies. My issue lies with the manner in which the service is provided.

You express personal disquiet with one breath, but turn about to dismiss specific charges as simplistic/selective misinterpretation of highly complex issues.

You say you recognise that issues exist within the industry, but in the face of claims (not to mention actual evidence) that the industry is choosing trial locations, entirely because of a lax (or entirely non-existent) regulatory framework, you then claim that the industry "do try to mitigate it as best they can." That my fine feathered friend is straight up schizoid doublespeak.

You essentially defend the industry's practice of overstepping ethical boundaries wherever the law permits, blaming a lack of legal restraint for tempting the industry into taking those ethical missteps, and then saying it's all alright, because said industry is having lots of round table discussions on this "complicated ethical issue".

So fucking what? London to a house-brick, that for every one of these ethics meetings, there are other meetings stuffed with lawyers, in which the entirety of the subject under discussion is "EXACTLY WHAT CAN BE GOTTEN AWAY WITH, AS CIRCUMSTANCES CURRENTLY STAND!"

Close minded? Moi?

Damned straight, when it comes to the modern corporate practice of placing maximising profit above all other considerations instead of asking "How can we make a fair profit whilst providing the best possible service to our customers/clients?"

DAMNED STRAIGHT when it comes to the ridiculous modern idea that any entity which services the common weal (be it a drug company, utility, transport service, or whatever) must be profitable in each and every one of its individual parts. That a cancer drug must pay for itself at $10k a dose, rather than be funded a fraction of cent at a time on the back of a hundred billion doses of aspirin, and sold for the price of manufacture plus a reasonable margin.

NO, No, no! Far better to cut the price of aspirin that fraction of a cent more and and work on driving one more competitor to the wall.

DAMNED FUCKING STRAIGHT when it comes to that sort of devil take the hindmost thinking.

I note with interest, that YOU had nothing to say in response to the known practices of: Deliberate supression of negative data; Cherry picking data for confirmatory results; and collusion to fix prices.

As for my spelling, all fumble fingered typos. Shoot me for not using a spell checker which refuses to recognise the language as I was taught it. I get a bit sick of being told what I damned well know is correct, is wrong, twenty-'leven times in order to find a few errors. If my eye misses my finger's dyslexia, it misses it. Get over it.

[rexcat]

50. Now that is quite a rant...

and yes there has been cherry picking of data at times but I believe that it happens on occasion, not the majority of the time like you imply and that also goes for the suppression of data. When it does happen bad things usually occur but when this is discovered the FDA and/or the justice department slaps the wrist of the company involved and that is not right. There is now a clearinghouse for studies that do not answer the hypothesis, so yes negative studies are now reported.

There have been some instances to fix prices but again you make it look like it is happening all of the time. This country does not regulate the price of pharmaceuticals and until there is single payer universal health care in this country I don't see prices of pharmaceuticals being regulated. A reality that seems to escape you.

You did not address this issue because your supposition was incorrect but that seems to be a common theme of yours

What other markets are comparable to the US market in pharmaceuticals? I don't think it is Europe since health care is socialized and the government pays for the drugs. It is not Australia or Japan since they are like Europe. What markets are you referring to? Russia? India?

I find this statement of yours as believable as the easter bunny being real. Sure you do!

AS A MATTER OF FACT I have defended the pharmaceutical industry, cops, and many other favourite DU whipping boys on a number of occasions, when the circumstances warranted it. AND put the boot to things I generally advocate in favour of, when I've been confronted with reason to do so there.

This statement is simplistic coming from a simplistic mind that really does not know the issues.

You say you recognise that issues exist within the industry, but in the face of claims (not to mention actual evidence) that the industry is choosing trial locations, entirely because of a lax (or entirely non-existent) regulatory framework, you then claim that the industry "do try to mitigate it as best they can." That my fine feathered friend is straight up schizoid doublespeak.

As far as your spelling this just shows your are sloppy, lazy and lack attention to detail. Try coming into the twenty-first century and get a browser that will automatically spellcheck for you. That might take some effort on your part and that does not seem to be part of your character.

[neversaydie]

43. what's the difference?

bottom line is whether they're ethical

[rexcat]

52. The details do matter...

How accurate is the reporting in the article at hand? Could it be that the pharmaceutical companies actually tried to do it correctly or did the principal investigator doing the trial screwed it up or for that matter was it everyone involved in the trial who was not ethical. These are complicated issues. They are not just black and white scenarios. With more information one can draw better conclusions and look for better ways to fix the problems.

[DreamGypsy]

14. Calm down people - India has a Clinical Trials Registry and patient advocates...

An excerpt from http://ctri.nic.in/Clinicaltrials/login.php
(emphasis mine)

The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (NIMS), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication1, 2.

Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.

<much more on the website>

Registered trials are required to provide substantial background information including

Name of Ethics Committee and approval status
Provide name of Ethics Committee (EC) from whom approval has been sought; for multi-centre trials, add names of all ECs from whom approval has been sought; also provide approval status, i.e. submitted for approval or approved with date
.
Please indicate whether an EC is an Independent Ethics Committee or not. Mention EC approval status of each site separately even if it is “under review” and/or from the same IEC (please mention the city from which the IEC functions).
For PMS trials “Not applicable” or “No objection certificate obtained” as appropriate.

So, it appears that health organizations in India are working to ensure that clinical trials are ethically administered. The situation in India is apparently not as bleak as when the Bhopal disaster occurred.

Additionally, there is political action ongoing in India. In the Times of India article entitled '2,644 died during clinical trial of drugs in 7 years: Govt to SC, which describes a government official talking to the Supreme Court of India, the report is

NEW DELHI: As many as 2,644 people, called subjects, died during the clinical trials of 475 new drugs on human beings in last seven years and only 17 of the medicines were approved for marketing in India, the Centre has informed the Supreme Court.

Responding to allegations by NGO, Swasthya Adhikar Manch, in its PIL (Public Interest Litigation) that Indians were used as guinea pigs by foreign pharmaceutical majors for human trial of their new drugs, the Union health and family welfare ministry said of the 57,303 enrolled subjects, 39,022 completed the clinical trials.

So, what is the Non Government Organization Swasthya Adhikar Manch, which is the source of allegations and, apparently, of the 'guinea pig' characterization?

Swasthya Adhikar Manch (Health Right Forum) is a platform constituted for the rights of the people (Sangharsh) and constructive work (Nirman) on various issues related Health & Health rights. It is a network of various organizations working in Madhya Pradesh and other parts of India. The main objective of Swasthya Adhikar Manch is to create an awareness regarding issues related Health and Health rights in people through various means. It mainly includes organizing awareness programmes, expertise lectures and publishing various publications like posters, pamphlets, booklets etc. mainly on issues related health, Drugs and health rights of the people. The members of this organization are mainly Health experts, Doctors, Health activists and Social workers, Journalist working on issues related health since many years. The members of the Swasthya Adhikar Manch are also active members of the other organizations in health field which are also working in network with SAM. Recently on an issue of Drug Trial, Swasthya Adhikar Manch has organized a day long workshop cum lecture in collaboration with Lokmaitri, chaired by Dr. Karunakar Trivedi (Health Expert from Indore) and lectured by Dr. C. M. Gulathi (Editior, Monthly Index of Medical Specialties, New Delhi) dated 7th May 2011. SAM has also published a booklet ‘Drug Trial Upniveshwad Ka Naya Astra’ on the issue of drug trial which has been distributed throughout the country.

Then after with due concern towards victims of the unethical and illegal drug trials, the SAM has raised this issue through massive media campaigning, launching complaints to different concerned institutions (NHRC, DCGI, MCI, PMO etc.), formation and organization of Drug Trial Victim’s Organization, gathering facts & information through RTI etc. We knocked at all possible doors and got disappointment in returns as no any concrete action has been taken by concern institution. Finally it has filed a Public Interest Litigation (PIL) in the Supreme Court seeking justice for the Drug Trial Victims throughout nation. The SAM is currently a complainant in NHRC & first organization who have filed a PIL on a issue of Drug Trials in India. Now the work of the SAM has expanded as different cases from other states like Maharashtra, Bihar and Rajasthan are also coming to SAM for justice

There is a lot of material to look at on the Swasthya Adhikar Manch. I recommend looking through some of it.

But back to the Time of India article, here is part of what the government spokesman told the Supreme Court:

The secretary promised to the court for stringent regime on clinical trials on the recommendations of the Parliamentary Standing Committee, which faulted the Drugs and Cosmetics (Amendment) Bill, 2007.

He said: "On the advice of the ministry of law, the health ministry has proposed to withdraw the 2007 Bill and introduce a new Bill in its place after incorporating the recommendations of the Standing Committee. Accordingly, the ministry will introduce Drugs and Cosmetic (Amendment) Bill, 2013 in Parliament during the Budget session."

On January 3, the apex court had pulled up the Centre for its insensitivity to scores of deaths and serious adverse effects to thousands during clinical trial of new drugs and asked the health secretary to monitor implementation of the supervisory and scrutiny mechanism for human experiment of new drugs.

I hope this helps elucidate the situation.

[HiPointDem]

18. Reports: medicines are being tested on some of poorest people in India without their knowledge

Time after time in Indore, I heard a depressingly familiar tale of poor, often uneducated people saying how flattered and privileged they were made to feel as they were suddenly offered the chance to receive medicines usually out of their reach. All of them claim that, contrary to Indian laws governing drugs trials, there was no informed consent.

Dr Rai says he became concerned when he saw poor people being ushered in to the best consulting rooms. He says he was sacked from his job because of his questioning, but that he has been researching the hospital trials ever since. "They choose only poor people," he says, even though drug trial protocols demand that they should be carried out on all sections of society. "They chose poor, illiterate people who do not understand the meaning of clinical drug trials."

Dr KD Bhargava, head of the ethics committee at Maharaja Yeshwantrao Hospital, admits that the hospital's oversight of the trials has been flawed. "Suddenly lots of money got involved and there was too much going on. And, yes, maybe we may have lost control," he says.

But the issue goes well beyond one hospital. Since India relaxed its laws governing drugs trials in 2005, foreign drug companies have been keen to take advantage of the country's pool of educated, English-speaking doctors and the huge population from which to choose trial subjects.

http://www.bbc.co.uk/news/magazine-20136654

Overseas drug trials are a horrorshow. The same abuses that happened in the US are happening all over again.

Fuck the patient advocates and the registry. It's bullshit.

I hope this helps educate the situation.

[DreamGypsy]

19. And what are you personally doing to stop this...

...besides raising your blood pressure?

The people and government of India appear to have recognized a problem and appear to be working toward...no, not a solution...a remediation.

Perhaps you are suggesting that India adopt the practices and procedures of the U.S., which arrive at a speedy and mutually agreeable solution to every problem?

Note:

Dr Bharani has since been charged by the state government for receiving illegal payments and foreign trips from drug companies, and for carrying out drugs trials without patients' consent.

Dr KD Bhargava, head of the ethics committee at Maharaja Yeshwantrao Hospital, admits that the hospital's oversight of the trials has been flawed. "Suddenly lots of money got involved and there was too much going on. And, yes, maybe we may have lost control," he says.

I view these as possible inflection points for India's crisis. (they now have hospital ethics committees)

I am still searching for similar indicators in the U.S.

Sleep well, HPD.

[HiPointDem]

20. stupid post.

[rexcat]

35. There have been issues in the US...

because of the money. When a pharmaceutical company detects potential fraud during a study they are required to reported the situation to the FDA. The FDA then does a "for cause" audit. If fraud is detected it goes to the justice department and becomes a criminal investigation. There are more than a few doctors who have landed in federal prison here in the US. If it does not go to court the physician can be banned for life from doing clinical trials and they can potentially lose their medical license. You can go to the FDA site and look at the audit findings and actions doled out by the FDA (www.fda.gov).

We do have local and central institutional review boards (ethics committees; IRBs) in the US to oversee clinical trials. Over the past 8ish or so years the IRBs have been required to obtain certification and audits by the FDA and OHRP (Office of Human Research Protection; http://www.hhs.gov/ohrp/) have increased tremendously over that timeframe. Things have improved but there is always room for more improvement.

Unfortunately when people and money are involved it can lead to issues!

India and the other developing nations have issues both with regulations and the population (more poor and illiterate than seen in the industrial countries) which lead to issues the article was alluding to. Despite the accusations it is usually not the Pharmaceutical companies per se that are the problem. It is the people who are conducting the studies for them such as the physician you referenced but the money that the companies are will to pay out can be an issue also, especially in countries with low standards of living. We do see it here in the US because greed can overtake some people.

[DreamGypsy]

37. Absolutely. I am not an expert and have not thoroughly researched India's progress...

...but I consider the steps that have been and are being taken in India to capture data and monitor progress for clinical trials as good way-points for developing controls similar to those in the US. For example, the information required for their Clinical Trial Registry includes identification of all of the associates (ie. physicians) who will be implementing the trials.

I suspect, but did not find definitive statements during my limited searching, that the registry will also be recording trial subjects (patients) being treated by the associated physicians, and their outcomes. Data mining can then be used to look for patterns of abuse that could lead to charges and subsequent penalties.

Clinical trials are scientifically, ethically, economically, and politically complex. No truer words can be spoken than that there will always be room for improvement.

My wife is a biochemist and entrepreneur. She is co-founder and CEO of a company developing drugs for drug-resistant diseases. To be clear, this is not Big Pharma, this is ...uh, Tiny Pharma, about five people in the company. Up to this point they have been funded through NIH and through angel investors. The compounds that are furthest along in their pipeline are anti-malarial drugs that can be used in children and pregnant women and are effective against multiple drug resistant malaria strains. Several lead candidates have been taken through preclinical trials and look very promising. They have also some candidate drugs for MRSA. Her challenge is funding - NIH cutbacks have hurt the research program and US investors are skeptical since malaria is not an endemic disease. She has been in India several times in the last year to look for investors or corporate partners and to talk with groups who run clinical trials. One particular problem she described to me was that patients can be involved in more than one clinical trial simultaneously - obviously leading to greater health danger and to misleading results of the study. I would ask her to chime in knowledgeably on this thread, but she's in Australia at the moment, where one of her non-family tasks is to meet with a group there who could possibly run the clinical trials in Australia.

Thanks for your posts, rexcat. They are informative, well-written, and sane.

[rexcat]

51. It is not the responsibility of regulatory agencies...

to monitor the progress and data capture in clinical trials. That is the responsibility of the company that holds the New Drug Application (NDA) or whatever they call it in a specific country. The job of the regulators is to make sure that the physicians and their sites are in compliance of the local or country level regulations and that human subjects are protected. Of course this is also the responsibility of the pharmaceutical companies as well. To date the Indian government has not shown that it can do it. I think it comes down to the physicians who are picked by the pharmaceutical companies to run their studies in places like India. For the most part the pharmaceutical companies contract to Contract Research Organizations (CROs) in many countries where they don't have a major presence. If they don't pick truly qualified physicians this results in major cluster fucks happening.

My experience with working with small startup companies in pharmaceutics or biotechnology is they can lack understanding of the regulatory maze here in the US and abroad. The process is complicated but the FDA and other regulatory agencies in the developed world have programs in place to help those companies.

The sad thing in the US is we have a large group of people who think regulation is a waste of resources and have made regulatory agencies such as the FDA political. Our charming former President Bush did this. That is the worst thing anyone can do to that agency. Another issue with the pharmaceutical industry and the FDA is the revolving door situation with the regulators. They retire from the FDA and then work for the companies they regulated. This has a corrupting affect on the process.

Per all protocols in this country, EU, Japan and Australia no company typically allows subjects to participate in multiple trials. There are too many confounding issues with this scenario. This is always stated in the inclusion/exclusion criteria in the protocols for the studies I have worked on. That is the reason I have issues with placing studies in places like India.

[DreamGypsy]

56. Right. I didn't make my point very clearly about patient information.

I didn't intend to imply that all study data would be captured since that obviously could be patient confidential and/or study proprietary. However, something I read while perusing the background material suggested, to me at least, that India's Clinical Trial Registry would eventually capture information that could produce statistics like those reported in the article: number of patients, deaths related to the trial, total deaths, and adverse events, possibly grouped by enrolled physician; and generic information such as gender, age.

I looked though quite a bit of material the other day and I haven't rediscovered the text that led me to this conclusion.

Establishing the regulations, support, infrastructure, and enforcement for something as complex as clinical trials takes time. India certainly appears to be moving in the right directions, though perhaps not as quickly as some might deem necessary.

My wife has 40 years of experience in the biotech industry, starting with a large company and progressing through a number startups, some successful, some not. She is very comfortable with the clinical trial process and has a good network of contacts and advisers. Her current company uses CROs both in the US and abroad when appropriate. Funding is her biggest concern.

Thanks for the reply. You must also be very experienced in the industry.

[HiPointDem]

16. kr

[DeSwiss]

21. They learned from the best.....

Unethical human experimentation in the United States

Secret US Human Biological Experimentation

Government Experiments on U.S. Soldiers: Shocking Claims Come to Light in New Court Case

GAO Report - Human Experimentation: An Overview on Cold War Era Programs

Human medical experimentation in the United States: The shocking true history of modern medicine and psychiatry (1833-1965)

The St Louis Experiments

- K&R

[rexcat]

55. The United States...

is not the only country where this has happened. It has happened across the world. The point should be to know the history, study it and put measures in place to prevent these things from happening again.

As long as people are involved these types of things have the potential to happen again. Good regulations and strong enforcement are key to prevention.

[Locut0s]

28. Question is if these trials were done in India to circumvent safety regulations in other countries..

Or if this was just a particularly bad batch of trials. My money would be on the former but I don't have proof. Companies seem to love looking at people in poor foreign countries as cheap disposable garbage they can use. Not all companies but far too many.

[HiPointDem]

30. drug testing is being done, not only in india, but in the third world generally, because it's

cheaper and there's less oversight.

[rexcat]

53. Or could it be...

physicians who are not truly qualified to conduct the clinical trials or a combination of several factors.

[itsrobert]

33. Another one of those jobs, Americans won't do

But you bet the companies would like them to do it, if they could get away with it.

[Pterodactyl]

36. We should be testing on animals, not on people.

[DreamGypsy]

38. Preclinicals are in vitro or in vivo animal tests...

....but they are not perfect predictors of what a particular drug will do in humans.

Hence, the Phases of Clinical Research suggest/require subsequent testing on humans before the drug(s) are released of broad public use.

[nomorenomore08]

41. Ethical issues aside, animal testing is frequently unreliable.

Granted I have no problem with, say, life-saving cancer drugs being tested on animals. But what works on rats or monkeys may not work on humans.

[rexcat]

54. Really?

You are aware that the physiology of humans is different from every other species and vice versa. Also in pre-clinical studies there is a large amount of animal testing done prior to exposure in humans. Even with the animal studies showing a particular molecule is safe first time use in human studies (Phase I clinical trials) can detect serious problems (rarely but it happens) and people have died or been seriously injured because of it. If it were that easy the pharmaceutical companies would have been doing what you said. They will cut corners if allowed. One of the major reasons, IMO, why we need an FDA that is strong and not corrupted by the industry that it regulates.

[Pterodactyl]

57. OK, OK, you win. Let's test on people.