Parents Allege Pharmaceutical Giant Tricked Them With Experimental Vaccine
Protocol Compas is the name of the study designed to test the efficacy of Synflorix, GSK’s experimental pediatric pneumonia vaccine, which can also ward off the bacteria that causes meningitis and ear infections. Synflorix is still in the preapproval stage.
GSK compares Synflorix with Wyeth’s hugely successful Prevnar vaccine, which has proved effective in the United States. Besides Argentina, trials are also being conducted in Panama, Chile and Colombia.
In 1997, the United States conducted 5 percent of its clinical studies outside of the United States and Western Europe, according to a study conducted by Tufts Center for Drug Development. By 2007, that number had climbed to 29 percent.
Because of the multinational business of major drug companies, and how Americans fit in as U.S.-based employees and stockholders of GSK, as well as consumers of drugs that will be available in the U.S. market, there are global ramifications of clinical testing being conducted around the world.
The lion’s share of drug studies has gone to regions with “emerging markets”: Eastern Europe and Central Europe, Latin America, and south and Southeast Asia. In order for a region to be of use to a legitimate drug company, the country has to maintain a minimal level of infrastructure, says Mary Jo Lamberti, director of market research at the Boston-based Center Watch, a consulting firm that bills itself as the “Global Destination for Clinical Trials Information.”
Some parents say they didn’t know that their children were participating in a study at all. Others claim to have been coerced into participating — a suggestion rebutted by Ruttiman, who told ABCNews.com that participation is always voluntary and that parents “are informed, clearly and in a language they can understand, by experienced medical investigators.”
They are informed not only about the benefits, he says, such as round-the-clock access to medical care and vaccinations against diseases such as diphtheria, tetanus and hepatitis, but about potential risks.
He adds that “the vaccines used in this study may cause adverse reactions unknown up to now. … As with any vaccine, unexpected adverse events can arise, including allergic reactions.”
Trading participation in a medical trial for health care has become the standard operating procedure for drug companies and/or their medical contractors, according to Shah. Some see it as win-win, but Shah views the trade as nearly as coercive as the dramatic threat Ester alleges she received.
“The argument I make is that the drug companies are going [abroad] because people have less access to health care,” said Shah. “So they offer incentives and the choice is, ‘participate in the trial or your children won’t get health care.’ That’s not a choice. Being in an experiment is not the same as standard care. In an experiment [the drug] might work, you might get a placebo or it might be worse than nothing. They might suffer some terrible unforeseen consequence.”
It’s impossible to say whether the 12 babies’ deaths are due to the vaccine or not, because half of the [total number of] children were given a placebo,” the pediatrician told ABCNews.com through a translator. “But the way the study has been conducted is reprehensible.”
A large part of the problem lies in the consent form, says Marchese. The language in the 12-page document is so convoluted, she charges, that even she had to read it more than once to fully grasp its meaning. Another problem is how subjects say they were recruited, Marchese says.
Ovejero, who works as a part-time disc jockey, alleges the couple was misled by the “agente saniterio,” a kind of nurse’s aide, who told them about the study. “She did not say it was a test. She said it was a vaccine for his lungs that would keep him from getting worse.”
The Nigerian state of Kano is one well-publicized example. In 2004, Kano’s government refused to take part in the Global Polio Eradication Initiative sponsored by the World Health Organization out of fears that the immunizations constituted a plot to reduce the country’s Muslim population.
According to The Associated Press, the boycott was initiated after Pfizer faced accusations made by families and human rights groups of putting about 200 children at risk during what they claimed was a poorly managed meningitis study 11 years ago.
Eleven children died, while others suffered brain damage, according to the Nigerian government, which this summer filed suit against the London- and Connecticut-based pharmaceutical company. The case is still pending.