India Halts Wyeth Vaccine Trial Over Infant Death

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India Halts Wyeth Vaccine Trial Over Infant Death

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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).”