The highest-ever award in an Israeli class-action suit against a drug manufacturer – NIS 12.1 million – was recently made under a compromise agreement reached between a diabetes patient and GlaxoSmithKline, the maker of Avandia.
The suit had been filed by a diabetic who claimed that GSK had concealed data from the public that showed the drug, which is used to treat people with type-2 diabetes, increased the risk of dying from a heart attack.
The award is expected to be used to fund a new treatment program for diabetics.
Avandia was approved for treatment in 1999 and is included in the basket of health services covered by Israel's HMOs as a pre-treatment, to be used before insulin injections. During the past decade, it was one of the West’s most widely used drugs in diabetes treatment, with sales reaching $3.2 billion in 2006.
The Israel Diabetes Association estimates that some 30,000 Israeli diabetics have been given the drug, but since the summer of 2007, when the risks associated with it started to become known, that number has fallen to several thousand.
In May 2007, the New England Journal of Medicine published an article by two researchers who did a meta-analysis of 42 trials of Avandia. The two were able to demonstrate that the drug increased the chance of heart attack by 43%, and the risk of dying from a heart attack by 64%, compared to diabetics who were treated with other drugs or were given placebos.
In February 2010, an internal report by the U.S. Food and Drug Administration determined that the drug harmed the heart, and had been linked to 304 deaths from cardiac failure in the third quarter of 2009 in the U.S.
Following these reports, European regulators began their own reassessment of Avandia, and in October 2010 ordered the marketing of the drug stopped. But American and Israeli health officials continued to allow its use to treat diabetics whose blood sugar could not be stabilized by other drugs.
In July 2007, an Israeli diabetic filed a suit against GlaxoSmithKline in Tel Aviv District Court that was later recognized as a class-action. His attorneys, David Or-Chen and Tzvi Kahana, argued that the drug company had concealed the drug's risks from the public, even though it had evidence of the risk from at least as early as 2002, and that the drug was being distributed with information leaflets printed in 2000, in violation of Health Ministry requirements.
As part of the compromise arrangement, the drug maker rejected the claims, saying that “scientific information does not support a causal connection between the drug and the risk.” The award will not go to the claimant, but to train professionals who help treat diabetics, and toward the purchase of relevant treatments and drugs that are not included in the national health basket.
The compromise is being publicized to solicit comments from anyone who took the drug between 1999-2000, who believes that he or she suffered medical problems or financial harm from the drug.
After hearing objections, which is expected to take place later this week, the arrangement will require the approval of the attorney general.
GlaxoSmithKline responded by saying it “hopes the programs will provide significant support to patients and medical staff.”
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