The Islamic Post Blog


Pharmaceutical Ethics Remain In Question After Child-Deaths by Khalida
October 3, 2008, 8:45 pm
Filed under: Latino/Caribe, Sept/Oct Volume - 2008 | Tags: , , , ,
Dr. Joseph Glenmullen, above, concluded in his assessment that GSK knew about suicide risks of their drug Paxil.

Dr. Joseph Glenmullen, above, concluded in his assessment that GSK knew about suicide risks of their drug Paxil.

By Safiyah A. Khafidh, Islamic Post Staff Writer

Local authorities in northern Argentine province of Santiago del Estero are investigating the deaths of 7 children, out of a total of 14 Argentinian youth, who had apparently been administered Synflorix, an anti-pneumonia and antibiotic vaccine under testing in Latin America.
Synflorix is manufactured by the British company, GlaxoSmithKline (GSK), which company is the result of a merger of Glaxo Wellcome and the popular SmithKline Beecham in the year 2000.
There were also two reported deaths in Panama.
Although GSK refutes the possibility that the deaths are linked to Synflorix, the Health Professionals’ Labor Association (HPLA) in Santiago del Estero, one of the groups that notified the Argentine food and drug administration, believes the pharmaceutical giant bears some of the responsibility and is guilty of unethical testing.
“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,” Ana Maria Marchesse, a pediatrician at HPLA, told the Associated Press. “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.
GSK has also come under the scrutiny of U.S. Senate Finance Committee for not disclosing an alleged high suicide risk associated with children and adolescents taking their anti-depressant drug, Paxil.
Senator Brian Downey in February of this year and, in June, Senator Chuck Grassley   submitted reports in which they alleged GSK to have been aware of the suicidal effects of Paxil since 1989.
“The British counterpart to our country’s FDA found that GlaxoSmithKline withheld important safety data on Paxil,” Grassley said. “If the company engaged in this behavior in the U.K., then I want to make sure that the same didn’t happen here in the U.S. The FDA should investigate this question thoroughly and be forthcoming about its findings,” he stated in an official press release.
In a letter to the U.S. Food and Drug Administration, Senator Grassley claimed GSK hid deadly information about Paxil:
“For the last few years, I have been looking at how drug companies try and influence medical care in America. Companies can do this by, for example, creating studies favorable to their drugs, by hiring doctors to promote their products, and in some cases even intimidating critics of their drugs.
“Today, I would like to talk about a different tactic –drug companies hiding data. I don’t mean that they actually hide the data. But they make these numbers so difficult to find that they might as well be invisible.
“Last February, I asked GlaxoSmithKline to turn over a couple of reports on Paxil, a drug used to treat depression. These reports were written by Dr. Joseph Glenmullen, a professor of psychiatry at Harvard.
“Based on the review of documents uncovered in litigation, Dr. Glenmullen concluded that GlaxoSmithKline knew for almost two decades that Paxil is associated with an increased risk of suicide. He submitted these reports as an expert witness in several lawsuits now pending around the country.
“So what did GlaxoSmithKline do with these reports? Well, the company tried to hide them. They went to the judge and asked to have Dr. Glenmullen’s report and all the confirming documents placed under seal-that means that no member of the public could see them. In fact, Glaxo has been doing everything possible to ensure that this information remains under court seal.”
The senator subsequently requested a formal inquiry into the drug maker.
GSK, in their response to Sen. Grassley, called the issues raised by Dr. Glenmullen “scientifically flawed;” “old news” which had been “created to support plaintiffs’ allegations in litigation against GSK.” The response, however, dealt mainly with adult reactions to the drug and made no mention at all of a 64 million dollar settlement in 2007 made with parents of children who had taken Paxil.
GSK manufactures numerous vaccines besides Synflorix, along with other drugs such as Nicoderm, Zantac, Panadol, and Flonase. The company also produces common household items like Aquafresh toothpaste, and the Ribena nutritional juice supplement sold in the U.K.
GSK and Merck & Co., another pharma giant, are currently competing in the production of cervical cancer vaccines which are being heavily marketed in the U.S. and Canada to young girls and their mothers. The vaccine, said to help prevent the occurrence of the cancer in sexually active girls and young women, are on the required list for school vaccinations in one state so far, Virginia. Cervical cancer is classified as a sexually transmitted disease.
The Canadian government, in turn, plans to spend $300 million on the cervical cancer vaccine program, a move which has sparked debate. “This kind of money could be better used to solve so many other problems in women’s health,” Dr. Abby Lippman, a professor at McGill University in Canada and policy director of the Canadian Women’s Health Network told the New York Times, “Some of our provinces are running out of money to provide primary care. I’m not against vaccines, but in Canada and the U.S., women are not dying in the streets of cervical cancer.”
(It is of note that parents may, in fact, legally refuse to have the cervical cancer vaccine from being administered to their girls without offering an explanation, while other vaccinations may be refused for religious reasons as applies.)
The New York Times also reported Merck’s version of the vaccine as having received expedition from the FDA, and went from the application to approval stage in only six months. The process usually takes three years to complete and “5 to 10 more for universal acceptance,” according to Dr. Diane Harper, a professor of medicine at Dartmouth Medical School who worked with the World Health Organization on cervical cancer vaccine programs. She claims that those families whose girls are receiving the vaccines after the rush through FDA procedures should be “willing to accept the risk” as only adequate timing will reveal the side effects of the vaccine.
Both GSK and Merck continue to insist that safety is their primary concern.

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