14 more Children die in Drug clinical trials

This reality is imminent in Jamaica-sound de abeng.



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Argentina probes trial drug after 14 children die



BUENOS AIRES, Argentina (AP) -- Argentine authorities are investigating a possible link between the deaths of 14 children and an experimental vaccine they were taking in a clinical trial.
Argentina's food and drug agency has told The Associated Press that it is checking to see if the deaths are linked to the Synflorix vaccine, which is aimed at fighting pneumonia, ear infections and several other pneumococcal diseases.
The vaccine is manufactured by the British-based GlaxoSmithKline.
Sarah Alspach, a spokeswoman for the company in the U.S., says the company is not blaming the deaths on the vaccine.
She says data from other studies show it is about as safe as another widely used vaccine against pneumococcal disease.
Argentina investigates deaths of vaccinated kids
By DEBORA REY Associated Press Writer
BUENOS AIRES, Argentina — Argentine authorities are exploring a possible link between the deaths of 14 children and an experimental vaccine they were taking in a clinical trial run by GlaxoSmithKline.
Argentina's food and drug administration is investigating whether the deaths are tied to the Synflorix vaccine, said an agency official who spoke on condition of anonymity because he was not authorized to discuss the case.
The drug, designed to fight pneumonia, ear infections and several other pneumococcal diseases, was manufactured by the London-based GlaxoSmithKline PLC, the world's second-largest drug maker.
A U.S. spokeswoman for Glaxo, Sarah Alspach, said the company is not attributing the deaths to the experimental vaccine, which is being tested in three Latin American countries and in other countries around the world.
An independent board monitoring participants' safety recommended that the Latin American trials be temporarily suspended — which they were in late June — but then gave its OK for tests to resume, she added.
"We rely on their safety review," Alspach said. "Safety is our primary concern, always, with the development of any new treatment."
More than 19,000 babies have received at least one dose of Synflorix, which Glaxo plans to test on a total of 24,000 infants, she said. The company is still enrolling participants.
But according to the Argentine official, who works at the country's National Medicine, Food and Medical Technology Administration, the agency "received complaints about irregularities in the recruitment of patients" for the drug trial and on July 31 asked that recruitment be suspended.
Glaxo stopped recruiting the following day, saying it had already gathered the necessary number of participants, the official said.
Ana Maria Marchesse, who heads one of two groups that notified the national food and drug administration, told The Associated Press that she'd witnessed "poor ethical management" of patient recruitment.
"They didn't explain to the parents that this was an experimental vaccine, and a lot of the parents who signed consent forms were illiterate," said Marchesse, a pediatrician who heads the Health Professionals' Labor Association in the northern Argentine province of Santiago del Estero, where she said seven of the 14 children died.
"In some cases, they first gave them the vaccine and then gave them a 13-page consent form to sign that I had to read three times to understand," she added.
Marchesse said her group and a provincial doctors' association reported what they saw to the food and drug administration.
Glaxo's trial includes thousands of babies in Argentina, where Alspach said 12 children died; in Panama, where another two died; and in Chile. The natural infant death rate in those countries from pneumonia is 4 to 5 of every 1,000 live births — more than four times the rate seen in the study, Alspach said.
Pneumonia is the world's top killer among infectious diseases, causing more than 2 million deaths a year in children under five, mostly in developing countries, she said.
The company is testing the vaccine in more than 40 clinical studies around the world, she added. Data from other studies show the vaccine is about as safe and tolerable as competitor Wyeth's blockbuster Prevnar, a vaccine widely used against pneumococcal disease, she said.
Still, the Argentine province of Santiago del Estero is conducting a separate inquiry into the deaths of the seven children there, local Health Minister Franklin Moyano told state news media.
"While legal authorities investigate, we're in an observation phase to see if everything happened as expected, or if there were deviations that caused damage, in this case the death of seven kids," he said.

http://www.daytondailynews.com/l/content/shared-gen/ap/Health_Medical/Argentina_Childrens_Deaths.html?cxtype=rss&cxsvc=1&cxcat=0
Associated Press Business Writer Linda A. Johnson in Trenton, New Jersey, contributed to this report

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Body Count Linked to GSK Vaccine Trial Rises
By Jim Edwards
August 18th, 2008 @ 9:11 am

Fourteen children have now died during a pneumonia vaccine trial run by GlaxoSmithKline in Argentina, according to the U.K.’s Daily Mail. Argentine authorities are investigating. GSK says the deaths are not linked to the tests.


This issue first emerged for GSK in July, when TradingMarkets.com reported that 12 babies had died during the trial. GSK has pointed out that 19,000 kids have received Synflorix so far and that the number of kids who have died is in fact lower than Argentina’s natural child mortality rate.


Foreign drug trials are a PR tinderbox for drug companies (just ask Pfizer how its trials for Trovan in Nigeria turned out) and the Synflorix situation illustrates that perfectly. It has all the makings of a controversy for GSK — even if the company is completely innocent.
First, there’s the fact that GSK is testing Synflorix in a poorer country than the U.S. That naturally lends itself to allegations that the company is farming out the dangers to foreigners. True, but then in order to test a pneumonia vaccine you need to actually be in a country that has a significant number of pneumococcal infections, and they’re harder to find in the U.S.
Second, there’s the conflicted nature of local politics in foreign countries that don’t have a long history of democracy. In this case, one of the lead GSK investigators is Enrique Smith, who happens to be the brother of Juan Carlos Smith, the Argentine provincial health minister. So even if GSK has done nothing wrong, it just looks… weird.

Third, there’s the inconvenient timeline. Argentine authorities asked GSK to halt recruitment of new subjects in the trial, and GSK complied — but added that it had already gotten enough of them anyway.

Fourth, GSK’s independent safety monitor briefly halted the tests while it reviewed the situation, then allowed the tests to resume even though the Argentine province of Santiago del Estero is continuing its look at the trial. However, that province’s health minister is Juan Carlos Smith, so even if it comes back with a legitimate finding that there’s nothing wrong, people will ask questions about the role of the Smiths in the case, and why GSK continued its program even though the local government was still investigating.

In short, it’s a lose-lose situation for GSK, from a PR point of view, even if Synflorix turns out to be a wonder drug.

http://industry.bnet.com/pharma/1000175/body-count-linked-to-gsk-vaccine-trial-rises/