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 | Drug regulator cover on vaccine study aim by GS Mudur    </title>
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India&rsquo;s drug regulator has refused to disclose key information about a controversial government study that provided Indian girls a vaccine designed to protect them from cervical cancer, amplifying suspicions about the study&rsquo;s objectives.

The Drug Controller General of India (DCGI) has..."/>
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India&rsquo;s drug regulator has refused to disclose key information about a controversial government study that provided Indian girls a vaccine designed to protect them from cervical cancer, amplifying suspicions about the study&rsquo;s objectives.

The Drug Controller General of India (DCGI) has..." />
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                            <br /><div align="justify">India&rsquo;s drug regulator has refused to disclose key information about a controversial government study that provided Indian girls a vaccine designed to protect them from cervical cancer, amplifying suspicions about the study&rsquo;s objectives.<br /><br />The Drug Controller General of India (DCGI) has refused to release for public scrutiny the study&rsquo;s protocols, which are expected to contain information about its purpose and methodology, a set of health activists said yesterday.<br /><br />The Union government had suspended the study last year after health activists and women&rsquo;s groups had raised an alarm about possible breach of ethics in the study, which had delivered the vaccine to nearly 23,000 girls in Andhra Pradesh and Gujarat in 2009-10.<br /><br />A panel of doctors that probed the study has confirmed deficiencies and unethical practices but has claimed that no one can be held responsible.<br /><br />Earlier this month, MP Brinda Karat had described the panel&rsquo;s interim report as a &ldquo;strange mix of startling disclosures of serious deficiencies... and a blatant attempt to downplay the wrongdoing and exonerate those responsible&rdquo;.<br /><br />Karat has written to the Union health minister Ghulam Nabi Azad to identify those responsible for the study and take stern action against wrongdoers.<br /><br />The girls who were mainly between the ages of 10 and 14 years had received a vaccine against the human papilloma virus (HPV), which is expected to protect them from cervical cancer. This vaccine is already available through the private sector in India.<br /><br />But the DCGI, responding to requests under the Right to Information Act, has refused to release the study protocols, claiming they would contain &ldquo;trade secret(s) and commercial confidence of a third party,&rdquo; health activists said yesterday in the journal The Lancet.<br /><br />&ldquo;This response exposes an absolute lack of transparency,&rdquo; said Amit Sengupta, associate co-ordinator of the India branch of the People&rsquo;s Health Movement, a global network of non-government grassroots health organisations.<br /><br />&ldquo;The primary objective of the study is still not clear &mdash; we&rsquo;ve had so many conflicting claims from different organisations and different people,&rdquo; Sengupta told The Telegraph.<br /><br />An international non-government agency called PATH that had lent technical support to the study and the Indian Council of Medical Research that had approved it said it was aimed at examining the feasibility of delivering the vaccine through public health systems.<br /><br />The Bill and Melinda Gates Foundation had provided a grant and two vaccine manufacturers &mdash; Merck and GlaxoSmithKline &mdash; had donated vaccines for the study, which was executed by state health authorities in Andhra and Gujarat.<br /><br />Mark Feinberg, an official with Merck Vaccines in the US, had in a letter in the journal The Lancet last year described the study as a &ldquo;demonstration&rdquo; project that would help India gain experience on &ldquo;the most regionally appropriate immunisation strategies&rdquo;.<br /><br />But the panel appointed by the health ministry last year to probe the study has observed that four of the five primary outcome measures proposed in the study relate to evaluation of the safety of the vaccine.<br /><br />The DCGI has described the HPV vaccine project as a &ldquo;Phase IV&rdquo; study &mdash; a study, which although launched after marketing approval of a drug or a vaccine, is aimed at further evaluating efficacy or side-effects of the product in a large number of participants.<br /><br />&ldquo;We filed an appeal &mdash; and that was rejected too. We have now approached the Central Information Commissioner,&rdquo; said Anjali Shenoi, a member at SAMA, New Delhi, a non-government organisation tracking women&rsquo;s health issues.<br /><br />The panel investigating the study has also questioned the ethics of informed consent during the study. The Andhra government had issued a circular authorising hostel wardens and school masters to sign consent forms on behalf of minor girls.<br /><br />The HPV vaccine builds immunity against the virus which has been implicated in cervical cancer. Millions of girls across North America, Europe and Australia have received the vaccine since it was first approved about six years ago.</div>                                                           
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    <br><a href="http://www.telegraphindia.com/1110228/jsp/nation/story_13646373.jsp" class="re" target="_blank">The Telegraph, 28 February, 2011, http://www.telegraphindia.com/1110228/jsp/nation/story_13646373.jsp</a><div class="clear"></div>
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    <h1 class="cat-box-title">Drug regulator cover on vaccine study aim by GS Mudur</h1>
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                            <br /><div align="justify">India&rsquo;s drug regulator has refused to disclose key information about a controversial government study that provided Indian girls a vaccine designed to protect them from cervical cancer, amplifying suspicions about the study&rsquo;s objectives.<br /><br />The Drug Controller General of India (DCGI) has refused to release for public scrutiny the study&rsquo;s protocols, which are expected to contain information about its purpose and methodology, a set of health activists said yesterday.<br /><br />The Union government had suspended the study last year after health activists and women&rsquo;s groups had raised an alarm about possible breach of ethics in the study, which had delivered the vaccine to nearly 23,000 girls in Andhra Pradesh and Gujarat in 2009-10.<br /><br />A panel of doctors that probed the study has confirmed deficiencies and unethical practices but has claimed that no one can be held responsible.<br /><br />Earlier this month, MP Brinda Karat had described the panel&rsquo;s interim report as a &ldquo;strange mix of startling disclosures of serious deficiencies... and a blatant attempt to downplay the wrongdoing and exonerate those responsible&rdquo;.<br /><br />Karat has written to the Union health minister Ghulam Nabi Azad to identify those responsible for the study and take stern action against wrongdoers.<br /><br />The girls who were mainly between the ages of 10 and 14 years had received a vaccine against the human papilloma virus (HPV), which is expected to protect them from cervical cancer. This vaccine is already available through the private sector in India.<br /><br />But the DCGI, responding to requests under the Right to Information Act, has refused to release the study protocols, claiming they would contain &ldquo;trade secret(s) and commercial confidence of a third party,&rdquo; health activists said yesterday in the journal The Lancet.<br /><br />&ldquo;This response exposes an absolute lack of transparency,&rdquo; said Amit Sengupta, associate co-ordinator of the India branch of the People&rsquo;s Health Movement, a global network of non-government grassroots health organisations.<br /><br />&ldquo;The primary objective of the study is still not clear &mdash; we&rsquo;ve had so many conflicting claims from different organisations and different people,&rdquo; Sengupta told The Telegraph.<br /><br />An international non-government agency called PATH that had lent technical support to the study and the Indian Council of Medical Research that had approved it said it was aimed at examining the feasibility of delivering the vaccine through public health systems.<br /><br />The Bill and Melinda Gates Foundation had provided a grant and two vaccine manufacturers &mdash; Merck and GlaxoSmithKline &mdash; had donated vaccines for the study, which was executed by state health authorities in Andhra and Gujarat.<br /><br />Mark Feinberg, an official with Merck Vaccines in the US, had in a letter in the journal The Lancet last year described the study as a &ldquo;demonstration&rdquo; project that would help India gain experience on &ldquo;the most regionally appropriate immunisation strategies&rdquo;.<br /><br />But the panel appointed by the health ministry last year to probe the study has observed that four of the five primary outcome measures proposed in the study relate to evaluation of the safety of the vaccine.<br /><br />The DCGI has described the HPV vaccine project as a &ldquo;Phase IV&rdquo; study &mdash; a study, which although launched after marketing approval of a drug or a vaccine, is aimed at further evaluating efficacy or side-effects of the product in a large number of participants.<br /><br />&ldquo;We filed an appeal &mdash; and that was rejected too. We have now approached the Central Information Commissioner,&rdquo; said Anjali Shenoi, a member at SAMA, New Delhi, a non-government organisation tracking women&rsquo;s health issues.<br /><br />The panel investigating the study has also questioned the ethics of informed consent during the study. The Andhra government had issued a circular authorising hostel wardens and school masters to sign consent forms on behalf of minor girls.<br /><br />The HPV vaccine builds immunity against the virus which has been implicated in cervical cancer. Millions of girls across North America, Europe and Australia have received the vaccine since it was first approved about six years ago.</div>                                                           
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    <br><a href="http://www.telegraphindia.com/1110228/jsp/nation/story_13646373.jsp" class="re" target="_blank">The Telegraph, 28 February, 2011, http://www.telegraphindia.com/1110228/jsp/nation/story_13646373.jsp</a><div class="clear"></div>
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India&rsquo;s drug regulator has refused to disclose key information about a controversial government study that provided Indian girls a vaccine designed to protect them from cervical cancer, amplifying suspicions about the study&rsquo;s objectives.

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India&rsquo;s drug regulator has refused to disclose key information about a controversial government study that provided Indian girls a vaccine designed to protect them from cervical cancer, amplifying suspicions about the study&rsquo;s objectives.

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    <h1 class="cat-box-title">Drug regulator cover on vaccine study aim by GS Mudur</h1>
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                            <br /><div align="justify">India&rsquo;s drug regulator has refused to disclose key information about a controversial government study that provided Indian girls a vaccine designed to protect them from cervical cancer, amplifying suspicions about the study&rsquo;s objectives.<br /><br />The Drug Controller General of India (DCGI) has refused to release for public scrutiny the study&rsquo;s protocols, which are expected to contain information about its purpose and methodology, a set of health activists said yesterday.<br /><br />The Union government had suspended the study last year after health activists and women&rsquo;s groups had raised an alarm about possible breach of ethics in the study, which had delivered the vaccine to nearly 23,000 girls in Andhra Pradesh and Gujarat in 2009-10.<br /><br />A panel of doctors that probed the study has confirmed deficiencies and unethical practices but has claimed that no one can be held responsible.<br /><br />Earlier this month, MP Brinda Karat had described the panel&rsquo;s interim report as a &ldquo;strange mix of startling disclosures of serious deficiencies... and a blatant attempt to downplay the wrongdoing and exonerate those responsible&rdquo;.<br /><br />Karat has written to the Union health minister Ghulam Nabi Azad to identify those responsible for the study and take stern action against wrongdoers.<br /><br />The girls who were mainly between the ages of 10 and 14 years had received a vaccine against the human papilloma virus (HPV), which is expected to protect them from cervical cancer. This vaccine is already available through the private sector in India.<br /><br />But the DCGI, responding to requests under the Right to Information Act, has refused to release the study protocols, claiming they would contain &ldquo;trade secret(s) and commercial confidence of a third party,&rdquo; health activists said yesterday in the journal The Lancet.<br /><br />&ldquo;This response exposes an absolute lack of transparency,&rdquo; said Amit Sengupta, associate co-ordinator of the India branch of the People&rsquo;s Health Movement, a global network of non-government grassroots health organisations.<br /><br />&ldquo;The primary objective of the study is still not clear &mdash; we&rsquo;ve had so many conflicting claims from different organisations and different people,&rdquo; Sengupta told The Telegraph.<br /><br />An international non-government agency called PATH that had lent technical support to the study and the Indian Council of Medical Research that had approved it said it was aimed at examining the feasibility of delivering the vaccine through public health systems.<br /><br />The Bill and Melinda Gates Foundation had provided a grant and two vaccine manufacturers &mdash; Merck and GlaxoSmithKline &mdash; had donated vaccines for the study, which was executed by state health authorities in Andhra and Gujarat.<br /><br />Mark Feinberg, an official with Merck Vaccines in the US, had in a letter in the journal The Lancet last year described the study as a &ldquo;demonstration&rdquo; project that would help India gain experience on &ldquo;the most regionally appropriate immunisation strategies&rdquo;.<br /><br />But the panel appointed by the health ministry last year to probe the study has observed that four of the five primary outcome measures proposed in the study relate to evaluation of the safety of the vaccine.<br /><br />The DCGI has described the HPV vaccine project as a &ldquo;Phase IV&rdquo; study &mdash; a study, which although launched after marketing approval of a drug or a vaccine, is aimed at further evaluating efficacy or side-effects of the product in a large number of participants.<br /><br />&ldquo;We filed an appeal &mdash; and that was rejected too. We have now approached the Central Information Commissioner,&rdquo; said Anjali Shenoi, a member at SAMA, New Delhi, a non-government organisation tracking women&rsquo;s health issues.<br /><br />The panel investigating the study has also questioned the ethics of informed consent during the study. The Andhra government had issued a circular authorising hostel wardens and school masters to sign consent forms on behalf of minor girls.<br /><br />The HPV vaccine builds immunity against the virus which has been implicated in cervical cancer. Millions of girls across North America, Europe and Australia have received the vaccine since it was first approved about six years ago.</div>                                                           
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    <br><a href="http://www.telegraphindia.com/1110228/jsp/nation/story_13646373.jsp" class="re" target="_blank">The Telegraph, 28 February, 2011, http://www.telegraphindia.com/1110228/jsp/nation/story_13646373.jsp</a><div class="clear"></div>
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Drug regulator cover on vaccine study aim by GS Mudur

Published on Feb 27, 2011   Modified on Feb 27, 2011

India’s drug regulator has refused to disclose key information about a controversial government study that provided Indian girls a vaccine designed to protect them from cervical cancer, amplifying suspicions about the study’s objectives. The Drug Controller General of India (DCGI) has refused to release for public scrutiny the study’s protocols, which are expected to contain information about its purpose and methodology, a set of health activists said yesterday. The Union government had suspended the study last year after health activists and women’s groups had raised an alarm about possible breach of ethics in the study, which had delivered the vaccine to nearly 23,000 girls in Andhra Pradesh and Gujarat in 2009-10. A panel of doctors that probed the study has confirmed deficiencies and unethical practices but has claimed that no one can be held responsible. Earlier this month, MP Brinda Karat had described the panel’s interim report as a “strange mix of startling disclosures of serious deficiencies... and a blatant attempt to downplay the wrongdoing and exonerate those responsible”. Karat has written to the Union health minister Ghulam Nabi Azad to identify those responsible for the study and take stern action against wrongdoers. The girls who were mainly between the ages of 10 and 14 years had received a vaccine against the human papilloma virus (HPV), which is expected to protect them from cervical cancer. This vaccine is already available through the private sector in India. But the DCGI, responding to requests under the Right to Information Act, has refused to release the study protocols, claiming they would contain “trade secret(s) and commercial confidence of a third party,” health activists said yesterday in the journal The Lancet. “This response exposes an absolute lack of transparency,” said Amit Sengupta, associate co-ordinator of the India branch of the People’s Health Movement, a global network of non-government grassroots health organisations. “The primary objective of the study is still not clear — we’ve had so many conflicting claims from different organisations and different people,” Sengupta told The Telegraph. An international non-government agency called PATH that had lent technical support to the study and the Indian Council of Medical Research that had approved it said it was aimed at examining the feasibility of delivering the vaccine through public health systems. The Bill and Melinda Gates Foundation had provided a grant and two vaccine manufacturers — Merck and GlaxoSmithKline — had donated vaccines for the study, which was executed by state health authorities in Andhra and Gujarat. Mark Feinberg, an official with Merck Vaccines in the US, had in a letter in the journal The Lancet last year described the study as a “demonstration” project that would help India gain experience on “the most regionally appropriate immunisation strategies”. But the panel appointed by the health ministry last year to probe the study has observed that four of the five primary outcome measures proposed in the study relate to evaluation of the safety of the vaccine. The DCGI has described the HPV vaccine project as a “Phase IV” study — a study, which although launched after marketing approval of a drug or a vaccine, is aimed at further evaluating efficacy or side-effects of the product in a large number of participants. “We filed an appeal — and that was rejected too. We have now approached the Central Information Commissioner,” said Anjali Shenoi, a member at SAMA, New Delhi, a non-government organisation tracking women’s health issues. The panel investigating the study has also questioned the ethics of informed consent during the study. The Andhra government had issued a circular authorising hostel wardens and school masters to sign consent forms on behalf of minor girls. The HPV vaccine builds immunity against the virus which has been implicated in cervical cancer. Millions of girls across North America, Europe and Australia have received the vaccine since it was first approved about six years ago.

The Telegraph, 28 February, 2011, http://www.telegraphindia.com/1110228/jsp/nation/story_13646373.jsp

Tagged with: Health

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