Although 62 women have suffered serious adverse reactions
to the breast cancer drug Herceptin -- and 15 have died from it -- the manufacturer
continues to promote it.
In May, drug maker Genentech Inc. mailed a letter to doctors warning them about the
risks involved with their drug, yet the company's website continues to promote the drug to
potential patients. The contents of the warning letter can only be found by following a
small link to "New Safety Information." A link to the Food & Drug
Administration's comments on the letter resulted in an error page stating that the
requested document has "expired."
Genentech officials claim that severe reactions did not occur in the clinical trials
used to gain FDA approval. Yet, Genentech has issued a warning to study participants
stating that heart dysfunction was a common side effect of the drug.
At the FDA's Oncologic Drugs Advisory Committee meeting on September 2, 1998, testimony
was provided by a patient involved in the Genentech studies who had suffered damage to her
heart muscle, and heart dysfunction after taking Herceptin.
"Breast cancer patients like myself, who entered without complete information, now
have disabling heart dysfunction as a cost," stated Alice Hamele, from Farmington
Hills, Michigan.
Now, less than two years after approval, 15 women have died and dozens more have been
seriously affected by the drug.
SOURCES: Genentech Drug Warning Letter, May 3, 2000.
Oncologic Drugs Advisory Committee meeting, September 2, 1998.