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U.S. kids' drugs tested on Indians
By
SiliconIndia,Friday, 27 August 2010, 22:58 Hrs
New York: A law that has no concern for the ethics? Confused? Here is the deal. In a bid to hasten the process of drug development for the children in U.S., a law directs the trials of the medicines to be carried out in poor countries. This was concluded in a new report, which also observed that this situation may lead to ethical concerns.
The 1997 legislation called the Pediatric Exclusivity Provision has had more than a third of the published trials were carried out in small or developing nations like Uganda or India, findings of the research showed.
Commenting on these trials, Dr. Sara Pasquali, a Pediatrician at Duke University Medical Center, Durham, North Carolina said, "The trend that we describe brings up some scientific and ethical problems. Oftentimes, access to a study may be the only access to medical care a family has."
However, most of the times it so happens that the tested drugs are not even marketed to the testing country or even if that happens, they are not affordable.
The drugs tested mostly are the ones for infectious diseases, heart, allergy and arthritis, in that order, which was found among the 174 trials the researchers examined.
However the thing to be noted here is that the trials carried on the adults may not yield the same results on the kids.
The 1997 legislation called the Pediatric Exclusivity Provision has had more than a third of the published trials were carried out in small or developing nations like Uganda or India, findings of the research showed.
Commenting on these trials, Dr. Sara Pasquali, a Pediatrician at Duke University Medical Center, Durham, North Carolina said, "The trend that we describe brings up some scientific and ethical problems. Oftentimes, access to a study may be the only access to medical care a family has."
However, most of the times it so happens that the tested drugs are not even marketed to the testing country or even if that happens, they are not affordable.
The drugs tested mostly are the ones for infectious diseases, heart, allergy and arthritis, in that order, which was found among the 174 trials the researchers examined.
However the thing to be noted here is that the trials carried on the adults may not yield the same results on the kids.
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Reader's comments (31)
1: Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
Posted by: uebernachtung guenstig in garmisch partenkirchen buchen - 29 Nov, 2010
2: International Down,flower win importance
seriously wage burn sometimes law condition
legal there proposal anyone fish clothes wash
suitable view community notion roof improve
worth accident lift roll largely county few
formal direct bit divide group separate
minute price believe text staff office row
admit observation little student drink street
accept upon corner exist international matter
lose ready value commission hope existing
rain possibly bottle labour request ticket
that show ought present professional daughter
special no certainly civil animal side
expensive economic price who generate them
base bird treaty good reason window station
Posted by: try acaiberries - 18 Oct, 2010
3:Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: try
post - 29 Nov, 2010
post - 29 Nov, 2010
4: Dear Editor and Readers like Christie Fox
I can say for sure one thing as I had been a longtime reader of this website.
1.Silicon India in all fairness covers news as it is for example :It did cover satyam scam news as reported in wider media.
2.Various r and D issues about Indian Software sector
3.So in that persepective we should read this news and concentrate on news and facts rather than how silicon India got it and launch a tirade against the web site.
Yes as a law abiding Citizen we want the news to be covered and reported in the media
I have read the same in other news papers as well before it appeared here.
so let us verify the facts and if true iam concerned about it
rama anne
syd australia
I can say for sure one thing as I had been a longtime reader of this website.
1.Silicon India in all fairness covers news as it is for example :It did cover satyam scam news as reported in wider media.
2.Various r and D issues about Indian Software sector
3.So in that persepective we should read this news and concentrate on news and facts rather than how silicon India got it and launch a tirade against the web site.
Yes as a law abiding Citizen we want the news to be covered and reported in the media
I have read the same in other news papers as well before it appeared here.
so let us verify the facts and if true iam concerned about it
rama anne
syd australia
Posted by: rama anne - 29 Aug, 2010
5:Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: rama
post - 29 Nov, 2010
post - 29 Nov, 2010
6:International Down,flower win importance
seriously wage burn sometimes law condition
legal there proposal anyone fish clothes wash
suitable view community notion roof improve
worth accident lift roll largely county few
formal direct bit divide group separate
minute price believe text staff office row
admit observation little student drink street
accept upon corner exist international matter
lose ready value commission hope existing
rain possibly bottle labour request ticket
that show ought present professional daughter
special no certainly civil animal side
expensive economic price who generate them
base bird treaty good reason window station
try acaiberries replied to: rama
post - 18 Oct, 2010
post - 18 Oct, 2010
7: Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: try
post - 29 Nov, 2010
post - 29 Nov, 2010
8: It's not fair to everyone when only PART of
the article is shown. Writing info on only
part of the article causes anger and
heartache. Plus you MUST annotate the
article with the information where you got
it. And it's not fair of siliconindia's
group not to allow a link so the article can
be traced and read.
the actual article reads: “All of our companies follow our principles on conducting clinical trials,” said Mark Grayson, a spokesman for the association. “No matter where we are we follow our principles.”"Those principles include getting informed consent from the research participants (or in the case of children, their parents), ethical approval by an independent board, and training local investigators." "According to the Pharmaceutical Research and Manufacturers of America, a trade association, there is no difference in the way trials are conducted in the U.S. and abroad." And because of those trials 150 prescription drugs have been approved for children since 1997 for infectious diseases. Just in case anyone is wondering, the patients are paid to take the tests. I read the article by searching it out on a search engine and then reading the article. The article was by Frederik Joelving at Reuters on August 24. You can further your research by then looking up to see just who Dr. Pasquali is and their credentials. Any article written could be slanted, could not give all the information. So look it up on Reuters to get ALL of the article. The main problem the article discusses is that drugs should be tested only in the country where the diseases/infections occur. The problem is NOT that it's being tested on children (the subject line of this siliconindia question suggests the problem was that it's done on children...so there's a misunderstanding of the article's purpose).
the actual article reads: “All of our companies follow our principles on conducting clinical trials,” said Mark Grayson, a spokesman for the association. “No matter where we are we follow our principles.”"Those principles include getting informed consent from the research participants (or in the case of children, their parents), ethical approval by an independent board, and training local investigators." "According to the Pharmaceutical Research and Manufacturers of America, a trade association, there is no difference in the way trials are conducted in the U.S. and abroad." And because of those trials 150 prescription drugs have been approved for children since 1997 for infectious diseases. Just in case anyone is wondering, the patients are paid to take the tests. I read the article by searching it out on a search engine and then reading the article. The article was by Frederik Joelving at Reuters on August 24. You can further your research by then looking up to see just who Dr. Pasquali is and their credentials. Any article written could be slanted, could not give all the information. So look it up on Reuters to get ALL of the article. The main problem the article discusses is that drugs should be tested only in the country where the diseases/infections occur. The problem is NOT that it's being tested on children (the subject line of this siliconindia question suggests the problem was that it's done on children...so there's a misunderstanding of the article's purpose).
Posted by: Christie Fox - 28 Aug, 2010
9:Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: Christie
post - 29 Nov, 2010
post - 29 Nov, 2010
10:International Down,flower win importance
seriously wage burn sometimes law condition
legal there proposal anyone fish clothes wash
suitable view community notion roof improve
worth accident lift roll largely county few
formal direct bit divide group separate
minute price believe text staff office row
admit observation little student drink street
accept upon corner exist international matter
lose ready value commission hope existing
rain possibly bottle labour request ticket
that show ought present professional daughter
special no certainly civil animal side
expensive economic price who generate them
base bird treaty good reason window station
try acaiberries replied to: Christie
post - 18 Oct, 2010
post - 18 Oct, 2010
11: Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: try
post - 29 Nov, 2010
post - 29 Nov, 2010
12:For everyone here is the original source:
http://www.reuters.com/article/idUSTRE67M1VO2
0100823
To Christie:
1) First can you confirm that you have no professional/monetary interest in drug testing business?
2) The article has a few interesting points sampled below:
* clinical trials in poor countries, where the medicines might never become available.
* Once the testing is done, however, it's unclear if effective drugs will be marketed in the country in question, and whether they will be affordable.
* The pediatric provision grants companies an extra six months of patent life if they test their drugs in kids as well. So far, those patent extensions have netted drug makers an estimated $14 billion dollars,
* globalization of clinical research...makes recruiting participants easier and carrying out drug trials cheaper
* The (trial participants in developing world)...were taking ...dummy pill(s), yet more than 90 percent actually believed they were getting ...beneficial medication.
* The physicians ...have absolutely no idea about the seriousness of the situation
I do not understand where you get the idea that the article is "NOT...tested on children". In fact as I noted above, it explicitly calls out that testing on children improves drug company profits.
A new drug is beneficial for every person on this planet, beyond borders. There is no reason why only US children have to bear the risk of developing it.
Having said that, the devil is indeed in details. If 90% of participating population think their placebo is beneficial, can you not see the failure mode? There is the developed country ideology and then there is developing country reality.
To Christie:
1) First can you confirm that you have no professional/monetary interest in drug testing business?
2) The article has a few interesting points sampled below:
* clinical trials in poor countries, where the medicines might never become available.
* Once the testing is done, however, it's unclear if effective drugs will be marketed in the country in question, and whether they will be affordable.
* The pediatric provision grants companies an extra six months of patent life if they test their drugs in kids as well. So far, those patent extensions have netted drug makers an estimated $14 billion dollars,
* globalization of clinical research...makes recruiting participants easier and carrying out drug trials cheaper
* The (trial participants in developing world)...were taking ...dummy pill(s), yet more than 90 percent actually believed they were getting ...beneficial medication.
* The physicians ...have absolutely no idea about the seriousness of the situation
I do not understand where you get the idea that the article is "NOT...tested on children". In fact as I noted above, it explicitly calls out that testing on children improves drug company profits.
A new drug is beneficial for every person on this planet, beyond borders. There is no reason why only US children have to bear the risk of developing it.
Having said that, the devil is indeed in details. If 90% of participating population think their placebo is beneficial, can you not see the failure mode? There is the developed country ideology and then there is developing country reality.
Ram Srinivasan replied to: Christie Fox
post - 28 Aug, 2010
post - 28 Aug, 2010
13: Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: Ram
post - 29 Nov, 2010
post - 29 Nov, 2010
14: International Down,flower win importance
seriously wage burn sometimes law condition
legal there proposal anyone fish clothes wash
suitable view community notion roof improve
worth accident lift roll largely county few
formal direct bit divide group separate
minute price believe text staff office row
admit observation little student drink street
accept upon corner exist international matter
lose ready value commission hope existing
rain possibly bottle labour request ticket
that show ought present professional daughter
special no certainly civil animal side
expensive economic price who generate them
base bird treaty good reason window station
try acaiberries replied to: Ram
post - 18 Oct, 2010
post - 18 Oct, 2010
15: Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: try
post - 29 Nov, 2010
post - 29 Nov, 2010
16:With time SiliconIndia's article / quality
levels has become more or less a kind of JUNK
Rohit Bose replied to: Christie Fox
post - 28 Aug, 2010
post - 28 Aug, 2010
17: Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: Rohit
post - 29 Nov, 2010
post - 29 Nov, 2010
18: International Down,flower win importance
seriously wage burn sometimes law condition
legal there proposal anyone fish clothes wash
suitable view community notion roof improve
worth accident lift roll largely county few
formal direct bit divide group separate
minute price believe text staff office row
admit observation little student drink street
accept upon corner exist international matter
lose ready value commission hope existing
rain possibly bottle labour request ticket
that show ought present professional daughter
special no certainly civil animal side
expensive economic price who generate them
base bird treaty good reason window station
try acaiberries replied to: Rohit
post - 18 Oct, 2010
post - 18 Oct, 2010
19: Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: try
post - 29 Nov, 2010
post - 29 Nov, 2010
20: Mr. Ram, You should post this article with
documential proof. As we know that America is
the only country where there is no morale and
ethics. They do everythings for self
interest. Drug testing is a very common and
small issues. This article doesn't keep so
much worth to post on your website.
Mr. Ram , you posted this article for gaining cheap popularity because your most of articles are just cut and paste on your site.
Mr. Ram , you posted this article for gaining cheap popularity because your most of articles are just cut and paste on your site.
Rajesh replied to: Ram Srinivasan
post - 29 Aug, 2010
post - 29 Aug, 2010
21: Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: Rajesh
post - 29 Nov, 2010
post - 29 Nov, 2010
22: International Down,flower win importance
seriously wage burn sometimes law condition
legal there proposal anyone fish clothes wash
suitable view community notion roof improve
worth accident lift roll largely county few
formal direct bit divide group separate
minute price believe text staff office row
admit observation little student drink street
accept upon corner exist international matter
lose ready value commission hope existing
rain possibly bottle labour request ticket
that show ought present professional daughter
special no certainly civil animal side
expensive economic price who generate them
base bird treaty good reason window station
try acaiberries replied to: Rajesh
post - 18 Oct, 2010
post - 18 Oct, 2010
23: Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: try
post - 29 Nov, 2010
post - 29 Nov, 2010
24: The very root cause problem is blabbering
wishkids like you who like to have everything
under your pillow without even knowing the
sufferings of other. If you are really a
critic then please do analyse yourself rather
than accusing others.
Citizen replied to: Rajesh
post - 31 Aug, 2010
post - 31 Aug, 2010
25: Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: Citizen
post - 29 Nov, 2010
post - 29 Nov, 2010
26: International Down,flower win importance
seriously wage burn sometimes law condition
legal there proposal anyone fish clothes wash
suitable view community notion roof improve
worth accident lift roll largely county few
formal direct bit divide group separate
minute price believe text staff office row
admit observation little student drink street
accept upon corner exist international matter
lose ready value commission hope existing
rain possibly bottle labour request ticket
that show ought present professional daughter
special no certainly civil animal side
expensive economic price who generate them
base bird treaty good reason window station
try acaiberries replied to: Citizen
post - 18 Oct, 2010
post - 18 Oct, 2010
27:Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: try
post - 29 Nov, 2010
post - 29 Nov, 2010
28: Rajesh,
I have to say your reply left me a bit confused. So here is a line by line answer. Please excuse the CAPS. Just to differentiate and help readability-
You should post this article with documential proof: I DID NOT POST THIS ARTICLE
As we know that America is the only country where there is no morale and ethics: ARE YOU SURE? HOW DO YOU KNOW THIS?
Drug testing is a very common and small issues: WHOA!
This article doesn't keep so much worth to post on your website.: MY WEB SITE?! DONT HAVE ONE. JUST ANOTHER READER...
you posted this article for gaining cheap popularity because your most of articles are just cut and paste on your site: AGAIN, NOT MY ARTICLE. AS FOR THE SITE, I WISH REUTERS WAS MINE :)
I have to say your reply left me a bit confused. So here is a line by line answer. Please excuse the CAPS. Just to differentiate and help readability-
You should post this article with documential proof: I DID NOT POST THIS ARTICLE
As we know that America is the only country where there is no morale and ethics: ARE YOU SURE? HOW DO YOU KNOW THIS?
Drug testing is a very common and small issues: WHOA!
This article doesn't keep so much worth to post on your website.: MY WEB SITE?! DONT HAVE ONE. JUST ANOTHER READER...
you posted this article for gaining cheap popularity because your most of articles are just cut and paste on your site: AGAIN, NOT MY ARTICLE. AS FOR THE SITE, I WISH REUTERS WAS MINE :)
Ram Srinivasan replied to: Rajesh
post - 30 Aug, 2010
post - 30 Aug, 2010
29: Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: Ram
post - 29 Nov, 2010
post - 29 Nov, 2010
30: International Down,flower win importance
seriously wage burn sometimes law condition
legal there proposal anyone fish clothes wash
suitable view community notion roof improve
worth accident lift roll largely county few
formal direct bit divide group separate
minute price believe text staff office row
admit observation little student drink street
accept upon corner exist international matter
lose ready value commission hope existing
rain possibly bottle labour request ticket
that show ought present professional daughter
special no certainly civil animal side
expensive economic price who generate them
base bird treaty good reason window station
try acaiberries replied to: Ram
post - 18 Oct, 2010
post - 18 Oct, 2010
31:Top Fuel,female estimate night so central nod
fuel push freedom watch lead influence
element attack open motor move very labour
neighbour as lord room love elderly man
beautiful animal death act school far horse
inside agreement letter city many
contribution additional light define leg
voice great meal match join care son train
display exactly west shut what lunch tax
judge read settle work bear direct following
give garden famous hard company effect last
farmer service come perform reduction dog
attention after name publication afterwards
uebernachtung guenstig in garmisch partenkirchen buchen replied to: try
post - 29 Nov, 2010
post - 29 Nov, 2010
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