From the first Wyeth Prempro HRT trial in Little Rock, Arkansas:A 20-year veteran of the U. S. Food and Drug Administration testified Saturday about more than a dozen “red flags” that popped up in the last 30 years alerting Wyeth Pharmaceuticals to potential links between its hormone drugs and breast cancer.
Dr. John Gueriguian, an endocrinologist who was a medical director at the FDA from 1978 through 1998, testified Saturday that the endometrial cancer study “absolutely” was “a signal that the company should study what its drug is doing to the rest of the body.”
“It would make sense to begin investigating the next organ that responds to hormones,” he said.
Gueriguian, who approved and monitored new hormone drugs for the FDA, testified that signals indicating potential problems with new drugs often arise slowly.
“If all the blips are pointing in the same direction, if they add up, a drug company should say, ‘We have something that can’t be ignored, ’” he said.
Indeed, an internal Wyeth memo dated March 12, 1980, showed that an outside expert told Wyeth officials that “a well-founded, long-range and controlled epidemiological investigation” must be done to ascertain the effect of Premarin (Prempro minus the progestin) on breast cancer.
It wasn’t until a NIH funded study on Prempro’s potential cardiovascular benefits revealed a 24 percent increase in breast cancer in the women who took it, as opposed to those who took a placebo, that prescriptions for the drug dropped dramatically.
Wyeth are facing around 5,000 such lawsuits.
Source.
1 comment:
I only hope the jury is wise enough to understand that this woman's cancer came from hormones--and since she was post menopausal, the only source was the HRT she was on.
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