☀️ JOIN SPN MOBILE
Forums
New posts
Guru Granth Sahib
Composition, Arrangement & Layout
ਜਪੁ | Jup
ਸੋ ਦਰੁ | So Dar
ਸੋਹਿਲਾ | Sohilaa
ਰਾਗੁ ਸਿਰੀਰਾਗੁ | Raag Siree-Raag
Gurbani (14-53)
Ashtpadiyan (53-71)
Gurbani (71-74)
Pahre (74-78)
Chhant (78-81)
Vanjara (81-82)
Vaar Siri Raag (83-91)
Bhagat Bani (91-93)
ਰਾਗੁ ਮਾਝ | Raag Maajh
Gurbani (94-109)
Ashtpadi (109)
Ashtpadiyan (110-129)
Ashtpadi (129-130)
Ashtpadiyan (130-133)
Bara Maha (133-136)
Din Raen (136-137)
Vaar Maajh Ki (137-150)
ਰਾਗੁ ਗਉੜੀ | Raag Gauree
Gurbani (151-185)
Quartets/Couplets (185-220)
Ashtpadiyan (220-234)
Karhalei (234-235)
Ashtpadiyan (235-242)
Chhant (242-249)
Baavan Akhari (250-262)
Sukhmani (262-296)
Thittee (296-300)
Gauree kii Vaar (300-323)
Gurbani (323-330)
Ashtpadiyan (330-340)
Baavan Akhari (340-343)
Thintteen (343-344)
Vaar Kabir (344-345)
Bhagat Bani (345-346)
ਰਾਗੁ ਆਸਾ | Raag Aasaa
Gurbani (347-348)
Chaupaday (348-364)
Panchpadde (364-365)
Kaafee (365-409)
Aasaavaree (409-411)
Ashtpadiyan (411-432)
Patee (432-435)
Chhant (435-462)
Vaar Aasaa (462-475)
Bhagat Bani (475-488)
ਰਾਗੁ ਗੂਜਰੀ | Raag Goojaree
Gurbani (489-503)
Ashtpadiyan (503-508)
Vaar Gujari (508-517)
Vaar Gujari (517-526)
ਰਾਗੁ ਦੇਵਗੰਧਾਰੀ | Raag Dayv-Gandhaaree
Gurbani (527-536)
ਰਾਗੁ ਬਿਹਾਗੜਾ | Raag Bihaagraa
Gurbani (537-556)
Chhant (538-548)
Vaar Bihaagraa (548-556)
ਰਾਗੁ ਵਡਹੰਸ | Raag Wadhans
Gurbani (557-564)
Ashtpadiyan (564-565)
Chhant (565-575)
Ghoriaan (575-578)
Alaahaniiaa (578-582)
Vaar Wadhans (582-594)
ਰਾਗੁ ਸੋਰਠਿ | Raag Sorath
Gurbani (595-634)
Asatpadhiya (634-642)
Vaar Sorath (642-659)
ਰਾਗੁ ਧਨਾਸਰੀ | Raag Dhanasaree
Gurbani (660-685)
Astpadhiya (685-687)
Chhant (687-691)
Bhagat Bani (691-695)
ਰਾਗੁ ਜੈਤਸਰੀ | Raag Jaitsree
Gurbani (696-703)
Chhant (703-705)
Vaar Jaitsaree (705-710)
Bhagat Bani (710)
ਰਾਗੁ ਟੋਡੀ | Raag Todee
ਰਾਗੁ ਬੈਰਾੜੀ | Raag Bairaaree
ਰਾਗੁ ਤਿਲੰਗ | Raag Tilang
Gurbani (721-727)
Bhagat Bani (727)
ਰਾਗੁ ਸੂਹੀ | Raag Suhi
Gurbani (728-750)
Ashtpadiyan (750-761)
Kaafee (761-762)
Suchajee (762)
Gunvantee (763)
Chhant (763-785)
Vaar Soohee (785-792)
Bhagat Bani (792-794)
ਰਾਗੁ ਬਿਲਾਵਲੁ | Raag Bilaaval
Gurbani (795-831)
Ashtpadiyan (831-838)
Thitteen (838-840)
Vaar Sat (841-843)
Chhant (843-848)
Vaar Bilaaval (849-855)
Bhagat Bani (855-858)
ਰਾਗੁ ਗੋਂਡ | Raag Gond
Gurbani (859-869)
Ashtpadiyan (869)
Bhagat Bani (870-875)
ਰਾਗੁ ਰਾਮਕਲੀ | Raag Ramkalee
Ashtpadiyan (902-916)
Gurbani (876-902)
Anand (917-922)
Sadd (923-924)
Chhant (924-929)
Dakhnee (929-938)
Sidh Gosat (938-946)
Vaar Ramkalee (947-968)
ਰਾਗੁ ਨਟ ਨਾਰਾਇਨ | Raag Nat Narayan
Gurbani (975-980)
Ashtpadiyan (980-983)
ਰਾਗੁ ਮਾਲੀ ਗਉੜਾ | Raag Maalee Gauraa
Gurbani (984-988)
Bhagat Bani (988)
ਰਾਗੁ ਮਾਰੂ | Raag Maaroo
Gurbani (889-1008)
Ashtpadiyan (1008-1014)
Kaafee (1014-1016)
Ashtpadiyan (1016-1019)
Anjulian (1019-1020)
Solhe (1020-1033)
Dakhni (1033-1043)
ਰਾਗੁ ਤੁਖਾਰੀ | Raag Tukhaari
Bara Maha (1107-1110)
Chhant (1110-1117)
ਰਾਗੁ ਕੇਦਾਰਾ | Raag Kedara
Gurbani (1118-1123)
Bhagat Bani (1123-1124)
ਰਾਗੁ ਭੈਰਉ | Raag Bhairo
Gurbani (1125-1152)
Partaal (1153)
Ashtpadiyan (1153-1167)
ਰਾਗੁ ਬਸੰਤੁ | Raag Basant
Gurbani (1168-1187)
Ashtpadiyan (1187-1193)
Vaar Basant (1193-1196)
ਰਾਗੁ ਸਾਰਗ | Raag Saarag
Gurbani (1197-1200)
Partaal (1200-1231)
Ashtpadiyan (1232-1236)
Chhant (1236-1237)
Vaar Saarang (1237-1253)
ਰਾਗੁ ਮਲਾਰ | Raag Malaar
Gurbani (1254-1293)
Partaal (1265-1273)
Ashtpadiyan (1273-1278)
Chhant (1278)
Vaar Malaar (1278-91)
Bhagat Bani (1292-93)
ਰਾਗੁ ਕਾਨੜਾ | Raag Kaanraa
Gurbani (1294-96)
Partaal (1296-1318)
Ashtpadiyan (1308-1312)
Chhant (1312)
Vaar Kaanraa
Bhagat Bani (1318)
ਰਾਗੁ ਕਲਿਆਨ | Raag Kalyaan
Gurbani (1319-23)
Ashtpadiyan (1323-26)
ਰਾਗੁ ਪ੍ਰਭਾਤੀ | Raag Prabhaatee
Gurbani (1327-1341)
Ashtpadiyan (1342-51)
ਰਾਗੁ ਜੈਜਾਵੰਤੀ | Raag Jaijaiwanti
Gurbani (1352-53)
Salok | Gatha | Phunahe | Chaubole | Swayiye
Sehskritee Mahala 1
Sehskritee Mahala 5
Gaathaa Mahala 5
Phunhay Mahala 5
Chaubolae Mahala 5
Shaloks Bhagat Kabir
Shaloks Sheikh Farid
Swaiyyae Mahala 5
Swaiyyae in Praise of Gurus
Shaloks in Addition To Vaars
Shalok Ninth Mehl
Mundavanee Mehl 5
ਰਾਗ ਮਾਲਾ, Raag Maalaa
What's new
New posts
New media
New media comments
New resources
Latest activity
Videos
New media
New comments
Library
Latest reviews
Donate
Log in
Register
What's new
New posts
Menu
Log in
Register
Install the app
Install
Welcome to all New Sikh Philosophy Network Forums!
Explore Sikh Sikhi Sikhism...
Sign up
Log in
Discussions
Hard Talk
Interviews
Many Drugs For U.S. Kids Tested In Poor Countries
JavaScript is disabled. For a better experience, please enable JavaScript in your browser before proceeding.
You are using an out of date browser. It may not display this or other websites correctly.
You should upgrade or use an
alternative browser
.
Reply to thread
Message
<blockquote data-quote="Vikram singh" data-source="post: 132543" data-attributes="member: 1078"><p>By Frederik Joelving Frederik Joelving Mon Aug 23, 7:24 am ET </p><p> </p><p> NEW YORK (Reuters Health) – A law intended to speed up development of new drugs for U.S. kids has ended up financing clinical trials in poor countries, where the medicines might never become available.</p><p> That's the conclusion of a new report whose authors say the situation raises ethical concerns.</p><p> More than a third of the published trials performed under 1997 legislation called the Pediatric Exclusivity Provision were carried out at least partly in developing or transitioning nations, such as Uganda and India, researchers found.</p><p> "The trend that we describe brings up some scientific and ethical problems," said Dr. Sara K. Pasquali, a pediatrician at Duke University Medical Center in Durham, North Carolina, whose findings appear in the journal Pediatrics.</p><p> "Oftentimes, access to a study may be the only access to medical care a family has," she said of trial participants in developing countries. 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.</p><p> Among the 174 trials the researchers examined, drugs against infectious diseases were most likely to be tested in the developing world, closely followed by heart, allergy and arthritis medications.</p><p> "We are now using vulnerable people in vulnerable countries as drug laboratories," Dr. Marcia Angell, who was not involved in the new research, told Reuters Health. "It is all about dollars and cents."</p><p> "Whether in children or adults, no clinical trials should be done in undeveloped countries unless they are trials to test a drug for a disease that only occurs there," said Angell, who teaches social medicine at Harvard Medical School in Boston.</p><p> The idea behind the Pediatric Exclusivity Provision is to incentivize development of drugs for children in the U.S.</p><p> Because many diseases are rare in childhood, clinical trials usually target adults only, and their results don't automatically extend to kids. The pediatric provision grants companies an extra six months of patent life if they test their drugs in kids as well.</p><p> So far, those patent extensions have netted drugmakers an estimated $14 billion dollars, according to the U.S. Food and Drug Administration.</p><p> At the same time, more than 150 drugs have been approved for children since 1997, said Pasquali.</p><p> "There are certainly both advantages and disadvantages to consider," she said of the rapid globalization of clinical research, adding that it makes recruiting participants easier and carrying out drug trials cheaper.</p><p> 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.</p><p> "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."</p><p> 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.</p><p> But the meaning of something like "informed consent" might not be clear in a different cultural context. One study from 2008, for instance, tested how much women in Ghana understood about the clinical trial they were part of.</p><p> The women were taking either vitamin A or a dummy pill, yet more than 90 percent actually believed they were getting an active and beneficial medication. </p><p>M. Nabeel Ghayur, a pharmacologist who worked in drug development in Pakistan before joining McMaster University in Hamilton, Ontario, Canada, said conditions are similar in India and Pakistan. </p><p>"People actually have blind trust in their doctor in South Asia. They have no idea what drug development is, they have no idea what clinical trials are," he told Reuters Health. </p><p> He said there was little red tape in those countries, and that people would rarely ask about drug side effects and legal issues. </p><p>"Recruiting people is easy, getting informed consent is easy, getting approval is easy, paying the patients and paying the doctors is easy," Ghayur said. "The physicians and investigators have absolutely no idea about the seriousness of the situation." </p><p>Pasquali said drugmakers needed to be held to a higher standard. For instance, she said, they could be required to describe how appropriate a drug would be for the country in which it is to be tested. </p><p>In addition, transparency could be increased by publishing all trials in medical journals -- something that happened less than half the time for the trials done under the Pediatric Exclusivity Provision. (See Reuters Health story of Aug 2, 2010.) </p><p> "Children are a vulnerable population," Pasquali said. </p><p> SOURCE: <a href="http://link.reuters.com/gas77m" target="_blank">http://link.reuters.com/gas77m</a> Pediatrics, online August 23, 2010.</p></blockquote><p></p>
[QUOTE="Vikram singh, post: 132543, member: 1078"] By Frederik Joelving Frederik Joelving Mon Aug 23, 7:24 am ET NEW YORK (Reuters Health) – A law intended to speed up development of new drugs for U.S. kids has ended up financing clinical trials in poor countries, where the medicines might never become available. That's the conclusion of a new report whose authors say the situation raises ethical concerns. More than a third of the published trials performed under 1997 legislation called the Pediatric Exclusivity Provision were carried out at least partly in developing or transitioning nations, such as Uganda and India, researchers found. "The trend that we describe brings up some scientific and ethical problems," said Dr. Sara K. Pasquali, a pediatrician at Duke University Medical Center in Durham, North Carolina, whose findings appear in the journal Pediatrics. "Oftentimes, access to a study may be the only access to medical care a family has," she said of trial participants in developing countries. 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. Among the 174 trials the researchers examined, drugs against infectious diseases were most likely to be tested in the developing world, closely followed by heart, allergy and arthritis medications. "We are now using vulnerable people in vulnerable countries as drug laboratories," Dr. Marcia Angell, who was not involved in the new research, told Reuters Health. "It is all about dollars and cents." "Whether in children or adults, no clinical trials should be done in undeveloped countries unless they are trials to test a drug for a disease that only occurs there," said Angell, who teaches social medicine at Harvard Medical School in Boston. The idea behind the Pediatric Exclusivity Provision is to incentivize development of drugs for children in the U.S. Because many diseases are rare in childhood, clinical trials usually target adults only, and their results don't automatically extend to kids. 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 drugmakers an estimated $14 billion dollars, according to the U.S. Food and Drug Administration. At the same time, more than 150 drugs have been approved for children since 1997, said Pasquali. "There are certainly both advantages and disadvantages to consider," she said of the rapid globalization of clinical research, adding that it makes recruiting participants easier and carrying out drug trials cheaper. 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. "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. But the meaning of something like "informed consent" might not be clear in a different cultural context. One study from 2008, for instance, tested how much women in Ghana understood about the clinical trial they were part of. The women were taking either vitamin A or a dummy pill, yet more than 90 percent actually believed they were getting an active and beneficial medication. M. Nabeel Ghayur, a pharmacologist who worked in drug development in Pakistan before joining McMaster University in Hamilton, Ontario, Canada, said conditions are similar in India and Pakistan. "People actually have blind trust in their doctor in South Asia. They have no idea what drug development is, they have no idea what clinical trials are," he told Reuters Health. He said there was little red tape in those countries, and that people would rarely ask about drug side effects and legal issues. "Recruiting people is easy, getting informed consent is easy, getting approval is easy, paying the patients and paying the doctors is easy," Ghayur said. "The physicians and investigators have absolutely no idea about the seriousness of the situation." Pasquali said drugmakers needed to be held to a higher standard. For instance, she said, they could be required to describe how appropriate a drug would be for the country in which it is to be tested. In addition, transparency could be increased by publishing all trials in medical journals -- something that happened less than half the time for the trials done under the Pediatric Exclusivity Provision. (See Reuters Health story of Aug 2, 2010.) "Children are a vulnerable population," Pasquali said. SOURCE: [URL]http://link.reuters.com/gas77m[/URL] Pediatrics, online August 23, 2010. [/QUOTE]
Insert quotes…
Verification
Post reply
Discussions
Hard Talk
Interviews
Many Drugs For U.S. Kids Tested In Poor Countries
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to our use of cookies.
Accept
Learn more…
Top