Infant Deaths Disputed In Glaxo Vaccine Trial
13 CommentsBy Ed Silverman // July 15th, 2008 // 8:05 am
At least 12 babies who were part of a Glaxo clinical study to test the effectiveness of a vaccine against pneumonia have died over the past year in Argentina, reports TradingMarkets.com. And the study uses children from poor families, who are “pressured and forced into signing consent forms,” the Argentine Federation of Health Professionals, or Fesprosa, charged.
“This occurs without any type of state control” and “does not comply with minimum ethical requirements,” Fesprosa said, according to Argentine press reports cited by TradingMarkets. The vaccine trial is still ongoing despite denunciations, and those in charge of the study were cited by the Critica newspaper as saying that procedures are being carried out in a lawful manner.
Fesprosa’s Juan Carlos Palomares said that “in most cases, these are underprivileged individuals, many of them unable to read or write, who are pressured into including their children” in the trials. “The laboratory pays $8,000 for each child included in the study, but none (of that money) remains in the province that lends the public facilities and the health personnel for the private research.”
Since 2007, 15,000 children less than one year old from three Argentine provinces were enrolled. “Only 12 have died throughout the country, which is a very low figure if we compare it with the deaths produced by respiratory illnesses caused by the pneumococcal bacteria,” pediatrician Enrique Smith, one of the lead investigators, TradingMarkets reports. Glaxo maintains the death rate in the trial is the same as in other countries where the vaccine is being tested. (See the Glaxo statement below).
In Santiago del Estero, one of the country’s poorest provinces, the trials were authorized when Enrique’s brother, Juan Carlos Smith, was provincial health minister, according to Argentine media.
However, Ana Maria Marchese, a pediatrician who works at the children’s hospital in the provincial capital where the studies are being conducted, argues that “because they can’t experiment in Europe or the United States, they come to do it in third-world countries.”
“A lot of people want to leave the protocol but aren’t allowed; they force them to continue under the threat that if they leave they won’t receive any other vaccine,” claimed Julieta Ovejero, a great aunt of one of the six babies who died in the province of Santiago del Estero.
A Glaxo spokeswoman send us this statement: Glaxo “has extensive experience in conducting clinical studies worldwide, including in Latin America. Safety is always our primary concern in the development of any new treatment or vaccine. All studies are conducted according to the highest ethical and scientific standards and in compliance with international standards of Good Clinical Practice (GCP).
“Since the beginning of the study, COMPAS is monitored by an Independent Data Monitoring Committee (IDMC) to oversee the safety aspects of the study and to help ensure that the highest ethical, safety and compliance standards are followed, including informed consent. Enrollment in the trial is on a voluntary basis and trial participants are free to withdraw at any time.
“The COMPAS study is designed to evaluate the protective efficacy against pneumonia and acute otitis media of a pediatric pneumococcal conjugate vaccine compared to active control vaccines.” Glaxo goes on to note that the vaccine is being tested in Europe, Asia, Africa and Latin America.
And Glaxo maintains that “the infant post-neonatal mortality rate of children participating in the COMPAS study does not exceed the post-neonatal mortality rate in the countries participating in the study.” The drugmaker adds that pneumonia is the worldwide leading cause of death from infectious disease and is also responsible for more than two million deaths every year in children below five years of age,” mostly in developing countries.
Atlex
There’s not enough information available to make a comment as to whether there is something inherently wrong with this study or not. However, I think that those making complaints have hurt their credibility by making statements that are hard to believe. The one that makes me most suspicious is the report that the “laboratory” is paying $8,000 per child. Since the study has included ~15,000 participants, that would mean that the study costs are $120M. This is implausible.
James
Atlex, what you state is true. However, the investigator’s comment of “Only 12 have died throughout the country, which is a very low figure if we compare it with the deaths produced by respiratory illnesses caused by the pneumococcal bacteria” is callous. Even if true, it is simply stupid to say “Only 12 have died” as though that is okay. It sure as hell isn’t okay with 24 parents.
It was a major misstep for Glaxo to allow him to make such a statement to the media. Either through a contract or good old fashioned pressure, Glaxo’s PR dep’t should have ensured he knew to simply say “no comment” any timeissues like these are raised and refer the matter back to the company.
When people make statements such as this, it simply gives fire to the anti-pharma folks, and reinforces why the public at large has such a low opinion of pharma.
Atlex
James,
I agree that the statement was poorly phrased. I don’t know how much of that has to do with the translation (I assume the original story was in Spanish). I’m also not sure how much direct control Glaxo has over this set of events. One way or the other, I bet in the long run this turns out to be a non-story ginned up by groups looking to create their own version of the Constant Gardener.
Atlex
truthman30
One way or the other, I bet in the long run this turns out to be a non-story ginned up by groups looking to create their own version of the Constant Gardener.
Atlex
Dead children possibly exploited by a drug company is hardly a non story Atlex?..
It amazes me how you and the pharma brigade seem to be more concerned with public perception of the industry before ethics and good practice, surely if you concerned yourself more with these first you wouldn’t have to worry about public perception of the industry?…
As for the constant gardener..
http://archive.salon.com/books/review/2001/02/02/lecarre/index.html
John Le Caree said himself that “By comparison with the reality, my story [is] as tame as a holiday postcard.”
Having researched the industry for 6 years, I would have to agree with him…
Meg
Well, we have the Nigerian kids, the Polish kids, the Argentinian kids, and even U.S. poor kids (I’m counting Rebecca Riley). But who cares in Pharma? Deaths are irrelevant: The only thing that counts is greed.
ol cranky
So where’s the Argentine MOH? Did they evaluate the protocol and approve it to be conducted in the country? Are they evaluating the safety data?
Also, what was the cause of death for the children? They come from very poor families with limited access to health care - isn’t it possible the deaths were completely unrelated to the study or vaccine and the only reason anyone in Argentina is paying any attention to the deaths of these children is because they happen to have been in a drug trial that tracked these events?
H. H. FD\udenbrergm M.D., DDGM IOM
Mr. Silverman, keep up the good work.
Only adberse publicity will halt Glaxo’s inexcusablke begavior.
José
Boy - things seem to be getting out of hand here. I think the first comment by Atlex must be considered: “There is not enough information available…..”. While it may make us feel better to believe that the likes of GSK are simply out to use the poor for experimentation in the name of greed, I strongly doubt that this is the case.
Yes, there is no doubt that GSK along with all other vaccine developers and manufacturers are commercial entities with shareholders who require profits and up-lift in value [in fact most of these shareholders are probably pension funds and insurance companies that we all rely on]. But…there is also no doubt that GSK along with any other ethical vaccine developer, would place safety at the forefront of any clinical trial.
Before we condemn anyone, are there any data showing that the 12 deaths, as a percentage of the vaccinated cohort in the study, represent a statistically significant increase as compared to the normal death rate for a non-vaccinated population from the same region? Are there any data showing that these deaths are directly attributable to the vaccine?
If we truely want to stop vaccine development being in the hands of corporate profit making companies, then we must lobby our governments to go back to the old days of 50 years ago when all vaccine development was essentially state run and paid for by the taxpayer. Are we willing as taxpayers to foot the enormous costs of drug development? There are advantages to this approach, but I am also sure that there would also be disadvantages.
I have to believe that no-one at GSK or any other ethical vaccine development company, wants to see children die in a clincal study.
Lets be realistic folks
Anne
“Since the beginning of the study, COMPAS is monitored by an Independent Data Monitoring Committee (IDMC) to oversee the safety aspects of the study and to help ensure that the highest ethical, safety and compliance standards are followed, including informed consent. ”
If that’s their highest ethical and safety standards (12 deaths), I don’t want to know about their lowest.
truthman30
“I have to believe that no-one at GSK or any other ethical vaccine development company, wants to see children die in a clincal study.
Lets be realistic folks”
Not unless they were testing high does for toxicity?..
Atlex
truthman30,
I usually refrain from even engaging with you, but at times I can’t help but fall into that trap.
Is there any indication at all that Glaxo was testing high doses? Of course not. Plus, toxicity studies are never done in wide-scale studies such as this. The dose would have been determined in much earlier phases of research. There is a zero percent chance that they were testing high doses for toxicity.
Atlex
truthman30
Is there any indication at all that Glaxo was testing high doses? Of course not. Plus, toxicity studies are never done in wide-scale studies such as this. The dose would have been determined in much earlier phases of research. There is a zero percent chance that they were testing high doses for toxicity.
Atlex
Well, it was just a question Atlex?..
And thank you for refraining from engaging with me..
Just to note, the infamous tegenero - elephant man trial..
http://www.theregister.co.uk/2006/03/20/tegenero_trial_science/
I’m sure that looked innocent enough too at the time?
KMTGCP
Truthman30 (or anyone else?)
Is ther any further followup on the TeGenero story you so kindly provided the link for? Thanks.
KMTGCP