Taxotere (docetaxel anhydrous) is a chemotherapy drug commonly used to treat metastatic breast cancer. Since its initial approval by the U.S. Food and Drug Administration in 1996, it has gained additional approvals for treating cancers of the head, neck, stomach, and prostate, as well as non-small cell lung cancer.
One well-known, common side effect of chemotherapy is alopecia, or hair loss. In most cases, this hair loss is temporary. However, based on conclusions from a U.K. study conducted in 2013, up to 15 percent of women who undergo treatment with Taxotere experience permanent hair loss. The psychological and social consequences can be devastating, and even have a negative effect on long-term survival rates.
Significantly, the manufacturer, Sanofi-Aventis, issued a warning about the possibility of irreversible alopecia on package labels in the European Union and Canada in 2005. However, such warnings did not appear in the U.S. until a decade later. Sanofi’s own studies the following year suggested that the risk of permanent alopecia was approximately 3 percent, which the French pharmaceutical company decided did not warrant a warning for U.S. patients. However, independent studies conducted later that year indicated the figure was twice that high.
By now, it is abundantly clear that Sanofi-Aventis was fully aware of the risk of their product. However, instead of a clear warning, U.S. package labels contained only vague information about possible hair loss, with the claim that it “generally regrows.”
Taxotere is a synthetic version of a naturally occurring compound known as Taxol, manufactured by Bristol-Meyer Squibb. This drug, also used to treat a number of solid tumor cancers, is derived from the bark of the Pacific yew tree. Taxol is a plant alkaloid that has been demonstrated to inhibit the growth of malignant tumors.
Administered intravenously, Taxol can cause inflammation and tissue damage if not carefully administered. According to Levin Papantonio attorney Ben Gordon, who has been handling Taxotere litigation, Sanofi-Aventis believed it could improve upon Taxol. In 2016, he explained, “They made a synthetic version. It’s poison. It’s toxic. It’s the same molecule, but they made it twice as strong, so they could try to beat Bristol Myers and they could get that market share.”
This toxicity is what causes the permanent destruction of hair follicles.
Today, approximately 8,700 Taxotere patients who have suffered permanent hair loss have filed lawsuits, which have been centralized in the Eastern District of Louisiana. Last month, Judge Jane T. Milazzo issued an order scheduling the first bellwether trial, which will begin in May of 2019.
Four additional cases will go to trial starting in September 2019. Based on the outcomes of these five cases, Sanofi-Aventis may choose to settle with the remaining plaintiffs or find itself fighting an ongoing legal battle that could continue for several years.
It is worth noting that this is not the first time a major drug company has issued warnings about a product in Europe and Canada, but failed to do so in the U.S. Abilify, a neuroleptic medication used to treat schizophrenia, bipolar disorder and depression, has been associated with compulsive behaviors such as gambling, shopping and sex.
This side effect was known by the manufacturers, Otsuka and Bristol-Meyers Squibb, and warnings were included on packages sold in most of the world years before they appeared in the U.S. There is no clear reason for this, other than the fact that the U.S. operates a profit-driven health care system. Furthermore, the present F.D.A. is compromised to the point of being nearly useless.
Unfortunately, if these companies can squeeze out maximum profits before a day of reckoning arrives, and if that reckoning turns out be relatively inexpensive when weighed against those profits, they will choose the bottom line over human health and safety – every time.