462 deaths related to testing of experimental drugs on patients in India

[Guest guest]

462 deaths related to testing of experimental drugs on patients in India till

mid-2010 alone, show health ministry figures

Monday, August 9, 2010, 18:44

Deaths related to drug testing in humans are going exponentially high in India

as the country is becoming a choice destination for pharmaceutical giants to

conducts clinical studies of experimental drugs on real-time patients.

The number of deaths during clinical studies has been steadily increasing and as

many as 462 people, who were a part of clinical trials, died in the year 2010

alone till June, according to figures available with the Union Health Ministry.

There were 132 deaths in year 2007, 288 deaths in the year 2008 and 637 deaths

in year 2009 , say the data.

In April, Indian government suspended Merck's cervical cancer vaccine Gardasil

study in two states following reports of deaths of 4 girls and several

complications.

Gardasil was to be tested for its " acceptability and service delivery issues " in

about 32,000 girls aged 10-14 in the southern Indian state of Andhra Pradesh and

Western state of Gujarat.

Gardasil vaccination programme is being conducted jointly with PATH, a

Seattle-based NGO, the Indian Council of Medical Research (ICMR) and the two

state governments. The vaccination drive is funded by the Bill and Melinda Gates

Foundation

PATH-International, which is conducting the study for the maker of Gardasil

Merck, an American pharmaceutical company since July 2009, has described the

study as a " demonstration project. "

The human papilloma virus (HP) vaccine HPV vaccine Gardasil, meant to prevent

cervical cancer among women, has been alleged to have led to the death of the

four girls who were administered the dose in Khammam district of Andhra Pradesh.

Besides the death, more than 120 girls, who were given the vaccination, have

complained severe adverse reactions of stomach disorders, epilepsy, headaches

and early menarche.

Though officials say that deaths occurring due to negligence of the company

during trials is rare, such instances have come to light. The most recent case

being the trial of a human papilloma virus (HPV) vaccine in Andhra Pradesh,

where four girls died after being vaccinated. While, the Indian Council of

Medical Research (ICMR) halted the trials, experts are still investigating the

cause of the deaths.

New laws to prevent pharmaceutical companies from conducting clinical studies of

medicines involving humans without obtaining permission from accredited ethical

committees may soon come into force in India.

The proposed legislations will form part of a new Bill which the government is

going to introduce in the country to restrict unethical practices and streamline

the fast-growing clinical research industry in India.

The Union Health Ministry, under the government of India is reportedly

finalizing a statute for the biomedical research.

The Indian Council of Medical Research (ICMR), the apex body advising the

government on medical research is reportedly working on a draft Bill which

proposes the restriction.

The Bill titled `Biomedical Research Human Subjects Promotion and Regulation

Bill' may soon be introduced in the parliament.

Presently, there is no apex body to accredit investigators to clinical trials.

Prior to November 17, 2008 the number of clinical trials actually conducted in

government/private hospitals are not available with the Central drugs Standard

and Control Organization (CDSCO), as registration of clinical trial was

voluntary.

CDSCO has granted permissions to about 2000 clinical studies from the year 2004

till December 2009, reports said quoting official sources.

Indian government has made registration of all clinical trials conducted in the

country mandatory from 15th June 2009.

Registration of clinical trials in a publicly accessible registry is very

important as it improves the accountability of the stake-holders and also

ensures that key information is made available to the public,'' stated the

notification dated 1st of June, 2009.

The Clinical Trials Registry- India (CTRI) has been set up by the ICMR's

National Institute of Medical Statistics (NIMS) and is funded by the Department

of Science and Technology (DST) through the Indian Council of Medical Research

(ICMR).

The idea behind setting up of the Clinical Trials Registry-India (CTRI) is to

encourage all clinical trials conducted in India to be prospectively registered

before the enrollment of the first participant and to disclose details of the 20

mandatory items of the WHO International Clinical Trials Registry Platform

(ICTRP) dataset.

Clinical trial outsourcing market in India is forecasted to grow at a CAGR of

over 30% during 2010-2012 to around US$ 600 million by 2012, says new report by

RNCOS.

India will become one of the highest growing clinical trial destinations in the

world, with this kind of growth, according to the study titled " Booming Clinical

Trials Market in India " .

India is becoming a major hub for clinical studies because all the major

pharmaceutical and biotech players as well as major CROs are making India their

base for conducting global clinical trials.

Finding and recruiting patients � the most crucial part of the clinical

research � who can qualify for a clinical trial, is relatively much easier in

India as compared to the Western countries.

Increasing prevalence of diseases and low cost of clinical trials are other

factors promoting this market. Syngene and Quintiles are right on top in terms

of market share in a market which are rather crowd with more than 100 firms

working in India in the clinical trial market.

There has been a dramatic increase in the number of trials that have

got officially registered in Clinical Trials Registry-India (CTRI).

According to records collected by the Indian Council of Medical Research and the

Drug Controller General's office, between July-December 2007, only 11 trials

were registered. The number increased to 137 between Jan-Dec 2008 and then to an

all-time high of 546 between Jan-Dec 2009. This year, while January saw 58

trials registered, February recorded 60.

http://www.dancewithshadows.com/pillscribe/462-deaths-related-to-testing-of-expe\

rimental-drugs-on-patients-in-india-till-mid-2010-alone-show-health-ministry-fig\

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[Guest guest]

Dear Friends,

 

This is in reference to the web post 462 deaths related to testing of

experimental drugs on patients in India till mid-2010 alone, shows health

ministry figures dated Oct 15, 2010, we are submitting this letter to provide

you with the facts pertaining to the HPV Demonstration Project.

 

1. The vaccines used in the HPV Vaccines Demonstration Project in two districts

in Andhra Pradesh and Gujarat are not experimental products. These are products

licensed by the Drug Controller General of India, and are commercially available

in the country.

2. The HPV vaccines demonstration project carried out in these districts used

two HPV vaccines licensed in India, namely Gardasil and Cervarix.

3. The Indian government’s suspension directive in April, as we understand,

was applied to all interventions, studies and projects related to the HPV

vaccines in the country.

4. In this HPV demonstration project, PATH is a technical collaborating partner

to Indian Council of Medical Research (ICMR) and the state governments of Andhra

Pradesh and Gujarat. The two state governments implemented the demonstration

project through their public health systems in their respective areas.

5. This collaboration by PATH in India is part of a global project on

comprehensive cervical cancer prevention.

6. The vaccines used in the study were donated by Merck Sharp Dohme

Pharmaceuticals Ltd (MSD) and GlaxoKlime (GSK), but no study funding has

been provided by any of these companies to this project.

Hence, it would be incorrect to state that “PATH …is conducting the study

for the maker of Gardasil Merck.

Detailed information on the above is available on

http://www.path.org/news/an100422-hpv-india.php

We would like you to please consider the above information in response to the

web article. 

 

For further clarifications if required, kindly contact.

 

Prashant Jha

Consultant, Advocacy & Communications,

HPV Vaccines Project in India, PATH

09212206300; 07503006330