India Halts Wyeth Vaccine Trial Over Infant Death

[Guest guest]

They easily would give this vaccine to a child with a cardiac

disorder after approval also.

Vaccines never tested on sick kids who are later given the vaccine

Sheri

India Halts Wyeth Vaccine Trial Over Infant Death

http://www.pharmalot.com/2008/11/india-halts-wyeth-vaccine-trial-over-infant-dea\

th/

An infant in Bangalore, who had a pre-existing cardiac disorder, died

during a clinical trial for an advanced pneumonia vaccine. And

India's rules prohibit testing on human subjects with such conditions

without prior approval of the Drugs Controller General of India,

LiveMint reports.

Wyeth had been permitted to conduct tests only on healthy babies,

according to the regulator, LiveMint continues, adding that the trial

began last year was being conducted on 350 healthy babies who were

between 42 and 72 days old. Some 250 have already been tested and

Wyeth is still allowed to collect the data.

" The baby was suffering from a cardiac abnormality and should not

have been included in the trial at all. It seems that the

'inclusion-exclusion' criteria protocol has not been adhered to by

the investigator, " Surinder Singh, drugs controller general, tells

LiveMint. " We have suspended all further trials across the country. "

The incident brings to the fore an ongoing debate over allowing

foreign drugmakers to conduct what are called phase III trials here

for a drug that is not marketed anywhere else in the world. Until

January 2005, human trials for a molecule developed outside India

were allowed only under if the drug was already approved for use

abroad and was sold in the market.

Though the Indian regulator has suspended several drug trials in the

past, all of them have been over adverse reactions or efficacy

issues, and not for violation of the rules themselves, according to

drug regulation experts.

" This is the first reported instance I can recall, " Chandra Gulati,

one of India's top experts in drug regulations, and editor of Monthly

Index of Medical Specialities, tells LiveMint.

Under the inclusion-exclusion protocol, if the investigator or

drugmaker decides to include or exclude a subject from its trial for

not fitting into approved criteria such as age, weight and health

conditions, prior permission must be sought from the licensing

authority, in this case, DCGI.

It was not immediately clear at which link in the testing chain the

mistake occurred. Wyeth Ltd, the Indian unit, said the tests were

conducted by GVK Biosciences, contracted for the trials, LiveMint

writes, although Singh says Wyeth had conducted the trials on its own.

A GVK Biosciences spokeswoman tells LiveMint it couldn't comment

because of " client confidentiality " . The tests were done at

Bangalore's St 's Hospital's National Academy of Health Sciences.

The Wyeth phase III trial was part of global clinical trials to

assess the safety, tolerability and immunogenicity of a pneumococcal

conjugate vaccine that fights 13 strains of bacteria compared with

seven strains in the company's current vaccine, Prevnar.

Singh says he would be sending his drug inspectors to investigate the

death of the baby, next week. " Further action will be taken based

upon the outcome of our investigation, " he tells LiveMint. " We want

to take very stern action. You (the company) should select the right

type of child and subject. When the child has died, you are telling

us that the child had a cardiac abnormality. We will not allow

companies to fiddle with the safety system set out for clinical

trials in India. "

Wyeth says the child who died had been administered Prevnar and not

the new 13-strain variant.

" The event occurred in the control group, which used the current

worldwide standard vaccine for prevention of pneumococcal disease and

which has been administered safely more than 200 million times

worldwide during the past seven years, " a Wyeth spokesperson wrote

LiveMint in an email. The test was comparing efficacy of Prevnar and

the new variant.

Gulati predicted Wyeth would be eventually held responsible even if

it contracted a testing firm for the trials: " Ultimately, the sponsor

is legally responsible though if there is any injury, then in a court

case summons will also be issued to the investigator (for

negligence), hospital (for not monitoring the trial properly) and

DCGI (for not conducting inspection of the trial). "

[Guest guest]

There will come a time - I pray to God that it will happen in my

lifetime - when those who have pushed vaccines upon innocent, helpless

babies - doctors, pharmaceutical companies, government officials -

will be proven to have lied and cheated these instruments of death

into our children's bloodstream. When that occurs, the outcry will be

heard around the world and there will not be enough hiding places on

the globe for these murderers to hide or enough money to pay for

compensation. Of course, it will be too late for the babies, like this

poor child, to be saved. But we will be able to take satisfaction from

the fact that never again will anyone have to be pushed to poison

their child because for once and for all, it will be known as poison

and we will all wonder how it was we fell for the vaccine lie for as

long as we did.

When that time comes, will you be able to say that you did everything

in your power to help bring the truth out? Support your local pro-

vaccination choice organisation, speak to friends and family about

these tragedies and never, ever stay quiet about the dangers of

vaccination. Those of us who know owe it to others to speak our truth.

All the best,

Meryl

On 17/12/2008, at 7:33 AM, Sheri Nakken wrote:

> They easily would give this vaccine to a child with a cardiac

> disorder after approval also.

> Vaccines never tested on sick kids who are later given the vaccine

> Sheri

>

> India Halts Wyeth Vaccine Trial Over Infant Death

>

>

http://www.pharmalot.com/2008/11/india-halts-wyeth-vaccine-trial-over-infant-dea\

th/

>

> An infant in Bangalore, who had a pre-existing cardiac disorder,

> died during a clinical trial for an advanced pneumonia vaccine. And

> India's rules prohibit testing on human subjects with such

> conditions without prior approval of the Drugs Controller General of

> India, LiveMint reports.

>

> Wyeth had been permitted to conduct tests only on healthy babies,

> according to the regulator, LiveMint continues, adding that the

> trial began last year was being conducted on 350 healthy babies who

> were between 42 and 72 days old. Some 250 have already been tested

> and Wyeth is still allowed to collect the data.

>

> " The baby was suffering from a cardiac abnormality and should not

> have been included in the trial at all. It seems that the 'inclusion-

> exclusion' criteria protocol has not been adhered to by the

> investigator, " Surinder Singh, drugs controller general, tells

> LiveMint. " We have suspended all further trials across the country. "

>

>

> Meryl Dorey,

> President

> Australian Vaccination Network

> Enabling Australians to make informed health choices

> Editor

> Living Wisdom Magazine

> Empowering Positive Change

> PO Box 177

> BANGALOW NSW 2479

> Phone: (61 +2) 02 6687 1699

> FAX (61 +2) 02 6687 2032

> SKYPE: ivmmag

> meryl@...

> www.avn.org.au <http://www.avn.org.au/>

>