Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 150
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
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Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 151
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::index() - APP/Controller/ArtileDetailController.php, line 151
Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 97
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Warning (512): Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853 [CORE/src/Http/ResponseEmitter.php, line 48]
Code Context
            if (Configure::read('debug')) {

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        LATEST NEWS UPDATES | Clinical trial relief norms flawed -Rema Nagarajan    </title>
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-The Times of India

The new Central Drug Standards Control Organisation (CDSCO) guidelines meant to help calculate compensation in case of clinical trial related injury or death in a fair and equitable manner seem to be loaded against the very people..."/>
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-The Times of India

The new Central Drug Standards Control Organisation (CDSCO) guidelines meant to help calculate compensation in case of clinical trial related injury or death in a fair and equitable manner seem to be loaded against the very people..." />
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                            <div align="justify">-The Times of India<br /><br />The new Central Drug Standards Control Organisation (CDSCO) guidelines meant to help calculate compensation in case of clinical trial related injury or death in a fair and equitable manner seem to be loaded against the very people it is meant to help.<br /><br />The guidelines suggest a formula based on the income of the injured or dead person along with age and severity of disease. Such a formula raises questions about how the income or worth of a housewife, a student or child or an unemployed person would be evaluated if they happen to be affected trial subjects.<br /><br />While the guidelines suggest no upper income limit, the lower limit for income will be the minimum wage as prescribed in the Minimum Wage Act. This would be part of the formula to calculate compensation. This could encourage companies and contract research organizations to select poorer people as trial subjects to keep their potential liability low. There is already a skew towards selecting poorer people for trials in countries like India and this could make it worse.<br /><br />Inexplicably, for calculating the compensation, only about 40-50% of the person's income will be considered, as the rest &quot;would have been spent on himself by way of personal and living expenses&quot;. No explanation is given for how this conclusion was arrived at. By this logic, a person who earns Rs 50,000 a month spends half on own expenses and the spouse and two children or even dependent parents will all manage in the remaining Rs 25,000.<br /><br />Other factors that go into calculating compensation are the &quot;seriousness or severity of the disease&quot; the person was suffering from when joining the trial, which is to be assessed by the investigator of the study or trial, and the extent of injury or disability caused by the clinical trial. It is unclear who will determine the extent of disability or injury, which could be quite subjective. And in all these cases, the person is entitled to financial compensation as per the recommendations of the Ethics Committee.<br /><br />Trial investigators have financial relationships with companies sponsoring the trial as they are paid by them for conducting the trial. &quot;Many trials are taking place in private clinics of individual doctors whose sole motto is to make money. Can they be trusted to protect the interests of the subjects? Ethics Committees of private hospitals, where most trials are taking place, are appointed by owners and have hardly any powers to take decisions that can hurt their employers' income. Independent ethics committees are privately run and totally dependent on drug companies for their very survival,&quot; says Dr C M Gulhati, Editor of the Monthly Index of Medical Specialties.<br /><br />Over 2,374 persons are said to have died in clinical trials from January 2007 till June 2012. So far, only 33 families have been compensated for deaths and no one has received any compensation for injury or disability caused by a trial. The average amount received as compensation per death is Rs 2.75 lakh or $5,300.<br /><br />The new guidelines meant to improve this situation seem far from the goal. The silver lining is that since these are draft guidelines, they can be improved to ensure they truly secure justice and fair compensation for affected trial subjects.<br /><br /><strong>Double standards?<br /></strong><br /><em>Compensation in India<br /></em><br />Merck, Wyeth, Amagen, Sanofi and Pfizer - Rs 1.5 lakh (about $2,800) each to eight victims<br /><br />Bayer - Rs 2.5 lakh ($4,800) each to five cases<br /><br />Eli Lilly - Rs 2 lakh ($2850) each to two families and Rs 1 lakh ($1,950) to one family<br /><br />Average payment per dead trial participant - Rs 2.38 lakh ($4,500)<br /><br /><em>Compensation abroad<br /></em><br />Pfizer - $175,000 (Rs 96 lakh) each for 8 children who died in its Trovan trial in Nigeria<br /><br />Hoechst (now part of Sanofi Aventis) - 60,000 Euros (Rs 43.2 lakh) to family of women who died during trial of its anti-depressant drug, Alival. <br /></div>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/india/Clinical-trial-relief-norms-flawed/articleshow/17774407.cms" class="re" target="_blank">The Times of India, 27 December, 2012, http://timesofindia.indiatimes.com/india/Clinical-trial-relief-norms-flawed/articleshow/17774407.cms</a><div class="clear"></div>
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-The Times of India

The new Central Drug Standards Control Organisation (CDSCO) guidelines meant to help calculate compensation in case of clinical trial related injury or death in a fair and equitable manner seem to be loaded against the very people..."/>
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    <h1 class="cat-box-title">Clinical trial relief norms flawed -Rema Nagarajan</h1>
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		 Published on</span><span class="text-date"> Dec 27, 2012</span>
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                            <div align="justify">-The Times of India<br /><br />The new Central Drug Standards Control Organisation (CDSCO) guidelines meant to help calculate compensation in case of clinical trial related injury or death in a fair and equitable manner seem to be loaded against the very people it is meant to help.<br /><br />The guidelines suggest a formula based on the income of the injured or dead person along with age and severity of disease. Such a formula raises questions about how the income or worth of a housewife, a student or child or an unemployed person would be evaluated if they happen to be affected trial subjects.<br /><br />While the guidelines suggest no upper income limit, the lower limit for income will be the minimum wage as prescribed in the Minimum Wage Act. This would be part of the formula to calculate compensation. This could encourage companies and contract research organizations to select poorer people as trial subjects to keep their potential liability low. There is already a skew towards selecting poorer people for trials in countries like India and this could make it worse.<br /><br />Inexplicably, for calculating the compensation, only about 40-50% of the person's income will be considered, as the rest &quot;would have been spent on himself by way of personal and living expenses&quot;. No explanation is given for how this conclusion was arrived at. By this logic, a person who earns Rs 50,000 a month spends half on own expenses and the spouse and two children or even dependent parents will all manage in the remaining Rs 25,000.<br /><br />Other factors that go into calculating compensation are the &quot;seriousness or severity of the disease&quot; the person was suffering from when joining the trial, which is to be assessed by the investigator of the study or trial, and the extent of injury or disability caused by the clinical trial. It is unclear who will determine the extent of disability or injury, which could be quite subjective. And in all these cases, the person is entitled to financial compensation as per the recommendations of the Ethics Committee.<br /><br />Trial investigators have financial relationships with companies sponsoring the trial as they are paid by them for conducting the trial. &quot;Many trials are taking place in private clinics of individual doctors whose sole motto is to make money. Can they be trusted to protect the interests of the subjects? Ethics Committees of private hospitals, where most trials are taking place, are appointed by owners and have hardly any powers to take decisions that can hurt their employers' income. Independent ethics committees are privately run and totally dependent on drug companies for their very survival,&quot; says Dr C M Gulhati, Editor of the Monthly Index of Medical Specialties.<br /><br />Over 2,374 persons are said to have died in clinical trials from January 2007 till June 2012. So far, only 33 families have been compensated for deaths and no one has received any compensation for injury or disability caused by a trial. The average amount received as compensation per death is Rs 2.75 lakh or $5,300.<br /><br />The new guidelines meant to improve this situation seem far from the goal. The silver lining is that since these are draft guidelines, they can be improved to ensure they truly secure justice and fair compensation for affected trial subjects.<br /><br /><strong>Double standards?<br /></strong><br /><em>Compensation in India<br /></em><br />Merck, Wyeth, Amagen, Sanofi and Pfizer - Rs 1.5 lakh (about $2,800) each to eight victims<br /><br />Bayer - Rs 2.5 lakh ($4,800) each to five cases<br /><br />Eli Lilly - Rs 2 lakh ($2850) each to two families and Rs 1 lakh ($1,950) to one family<br /><br />Average payment per dead trial participant - Rs 2.38 lakh ($4,500)<br /><br /><em>Compensation abroad<br /></em><br />Pfizer - $175,000 (Rs 96 lakh) each for 8 children who died in its Trovan trial in Nigeria<br /><br />Hoechst (now part of Sanofi Aventis) - 60,000 Euros (Rs 43.2 lakh) to family of women who died during trial of its anti-depressant drug, Alival. <br /></div>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/india/Clinical-trial-relief-norms-flawed/articleshow/17774407.cms" class="re" target="_blank">The Times of India, 27 December, 2012, http://timesofindia.indiatimes.com/india/Clinical-trial-relief-norms-flawed/articleshow/17774407.cms</a><div class="clear"></div>
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        LATEST NEWS UPDATES | Clinical trial relief norms flawed -Rema Nagarajan    </title>
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The new Central Drug Standards Control Organisation (CDSCO) guidelines meant to help calculate compensation in case of clinical trial related injury or death in a fair and equitable manner seem to be loaded against the very people..."/>
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-The Times of India

The new Central Drug Standards Control Organisation (CDSCO) guidelines meant to help calculate compensation in case of clinical trial related injury or death in a fair and equitable manner seem to be loaded against the very people..." />
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    <h1 class="cat-box-title">Clinical trial relief norms flawed -Rema Nagarajan</h1>
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                            <div align="justify">-The Times of India<br /><br />The new Central Drug Standards Control Organisation (CDSCO) guidelines meant to help calculate compensation in case of clinical trial related injury or death in a fair and equitable manner seem to be loaded against the very people it is meant to help.<br /><br />The guidelines suggest a formula based on the income of the injured or dead person along with age and severity of disease. Such a formula raises questions about how the income or worth of a housewife, a student or child or an unemployed person would be evaluated if they happen to be affected trial subjects.<br /><br />While the guidelines suggest no upper income limit, the lower limit for income will be the minimum wage as prescribed in the Minimum Wage Act. This would be part of the formula to calculate compensation. This could encourage companies and contract research organizations to select poorer people as trial subjects to keep their potential liability low. There is already a skew towards selecting poorer people for trials in countries like India and this could make it worse.<br /><br />Inexplicably, for calculating the compensation, only about 40-50% of the person's income will be considered, as the rest &quot;would have been spent on himself by way of personal and living expenses&quot;. No explanation is given for how this conclusion was arrived at. By this logic, a person who earns Rs 50,000 a month spends half on own expenses and the spouse and two children or even dependent parents will all manage in the remaining Rs 25,000.<br /><br />Other factors that go into calculating compensation are the &quot;seriousness or severity of the disease&quot; the person was suffering from when joining the trial, which is to be assessed by the investigator of the study or trial, and the extent of injury or disability caused by the clinical trial. It is unclear who will determine the extent of disability or injury, which could be quite subjective. And in all these cases, the person is entitled to financial compensation as per the recommendations of the Ethics Committee.<br /><br />Trial investigators have financial relationships with companies sponsoring the trial as they are paid by them for conducting the trial. &quot;Many trials are taking place in private clinics of individual doctors whose sole motto is to make money. Can they be trusted to protect the interests of the subjects? Ethics Committees of private hospitals, where most trials are taking place, are appointed by owners and have hardly any powers to take decisions that can hurt their employers' income. Independent ethics committees are privately run and totally dependent on drug companies for their very survival,&quot; says Dr C M Gulhati, Editor of the Monthly Index of Medical Specialties.<br /><br />Over 2,374 persons are said to have died in clinical trials from January 2007 till June 2012. So far, only 33 families have been compensated for deaths and no one has received any compensation for injury or disability caused by a trial. The average amount received as compensation per death is Rs 2.75 lakh or $5,300.<br /><br />The new guidelines meant to improve this situation seem far from the goal. The silver lining is that since these are draft guidelines, they can be improved to ensure they truly secure justice and fair compensation for affected trial subjects.<br /><br /><strong>Double standards?<br /></strong><br /><em>Compensation in India<br /></em><br />Merck, Wyeth, Amagen, Sanofi and Pfizer - Rs 1.5 lakh (about $2,800) each to eight victims<br /><br />Bayer - Rs 2.5 lakh ($4,800) each to five cases<br /><br />Eli Lilly - Rs 2 lakh ($2850) each to two families and Rs 1 lakh ($1,950) to one family<br /><br />Average payment per dead trial participant - Rs 2.38 lakh ($4,500)<br /><br /><em>Compensation abroad<br /></em><br />Pfizer - $175,000 (Rs 96 lakh) each for 8 children who died in its Trovan trial in Nigeria<br /><br />Hoechst (now part of Sanofi Aventis) - 60,000 Euros (Rs 43.2 lakh) to family of women who died during trial of its anti-depressant drug, Alival. <br /></div>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/india/Clinical-trial-relief-norms-flawed/articleshow/17774407.cms" class="re" target="_blank">The Times of India, 27 December, 2012, http://timesofindia.indiatimes.com/india/Clinical-trial-relief-norms-flawed/articleshow/17774407.cms</a><div class="clear"></div>
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Home हिन्दी

Clinical trial relief norms flawed -Rema Nagarajan

Published on Dec 27, 2012   Modified on Dec 27, 2012

-The Times of India The new Central Drug Standards Control Organisation (CDSCO) guidelines meant to help calculate compensation in case of clinical trial related injury or death in a fair and equitable manner seem to be loaded against the very people it is meant to help. The guidelines suggest a formula based on the income of the injured or dead person along with age and severity of disease. Such a formula raises questions about how the income or worth of a housewife, a student or child or an unemployed person would be evaluated if they happen to be affected trial subjects. While the guidelines suggest no upper income limit, the lower limit for income will be the minimum wage as prescribed in the Minimum Wage Act. This would be part of the formula to calculate compensation. This could encourage companies and contract research organizations to select poorer people as trial subjects to keep their potential liability low. There is already a skew towards selecting poorer people for trials in countries like India and this could make it worse. Inexplicably, for calculating the compensation, only about 40-50% of the person's income will be considered, as the rest "would have been spent on himself by way of personal and living expenses". No explanation is given for how this conclusion was arrived at. By this logic, a person who earns Rs 50,000 a month spends half on own expenses and the spouse and two children or even dependent parents will all manage in the remaining Rs 25,000. Other factors that go into calculating compensation are the "seriousness or severity of the disease" the person was suffering from when joining the trial, which is to be assessed by the investigator of the study or trial, and the extent of injury or disability caused by the clinical trial. It is unclear who will determine the extent of disability or injury, which could be quite subjective. And in all these cases, the person is entitled to financial compensation as per the recommendations of the Ethics Committee. Trial investigators have financial relationships with companies sponsoring the trial as they are paid by them for conducting the trial. "Many trials are taking place in private clinics of individual doctors whose sole motto is to make money. Can they be trusted to protect the interests of the subjects? Ethics Committees of private hospitals, where most trials are taking place, are appointed by owners and have hardly any powers to take decisions that can hurt their employers' income. Independent ethics committees are privately run and totally dependent on drug companies for their very survival," says Dr C M Gulhati, Editor of the Monthly Index of Medical Specialties. Over 2,374 persons are said to have died in clinical trials from January 2007 till June 2012. So far, only 33 families have been compensated for deaths and no one has received any compensation for injury or disability caused by a trial. The average amount received as compensation per death is Rs 2.75 lakh or $5,300. The new guidelines meant to improve this situation seem far from the goal. The silver lining is that since these are draft guidelines, they can be improved to ensure they truly secure justice and fair compensation for affected trial subjects. Double standards? Compensation in India Merck, Wyeth, Amagen, Sanofi and Pfizer - Rs 1.5 lakh (about $2,800) each to eight victims Bayer - Rs 2.5 lakh ($4,800) each to five cases Eli Lilly - Rs 2 lakh ($2850) each to two families and Rs 1 lakh ($1,950) to one family Average payment per dead trial participant - Rs 2.38 lakh ($4,500) Compensation abroad Pfizer - $175,000 (Rs 96 lakh) each for 8 children who died in its Trovan trial in Nigeria Hoechst (now part of Sanofi Aventis) - 60,000 Euros (Rs 43.2 lakh) to family of women who died during trial of its anti-depressant drug, Alival.

The Times of India, 27 December, 2012, http://timesofindia.indiatimes.com/india/Clinical-trial-relief-norms-flawed/articleshow/17774407.cms

Tagged with: medicines Law and Justice Health

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