Did Sanofi-Aventis Lie About Taxotere Side Effects?

Despite more than $3 Billion in revenue, Taxotere® is not a household name – unless you are one of the 300,000 American women treated for breast cancer each year. About 75 percent of all breast cancer patients are treated with Taxotere or Docefrez, both chemotherapy drugs. Since 2009, other companies have marketed competing products containing the same active molecule – docetaxel.

Certainly now, with a growing presence of the word in the news and on the Internet, many more people are starting to learn about Taxotere, but not for a good reason. Sanofi-Aventis, the manufacturer of Taxotere, is now facing nearly a thousand lawsuits in the United States alone. These lawsuits mostly revolve around an undisclosed side effect of the drug: permanent hair loss (permanent significant alopecia). As with other chemotherapy drugs of the same class, Taxotere was labeled with a warning about temporary hair loss.

That reality is, however, that now nearly a thousand plaintiffs know their hair loss is not and never was temporary, but it’s too late. Given this, it’s no wonder Taxotere litigation continues to mount. Over a hundred new Taxotere lawsuits were filed in April of this year alone.

Hair Matters… A Lot

Compared to breast cancer – one the three deadliest cancers in America – hair loss may seem trivial, but people affected by Taxotere alopecia have good reason be to be angry. Here’s why:

  1. The whole problem was avoidable. There are other drugs, like Taxol®, which many patients could have opted for instead. Had patients known up front about the risks of Taxotere, they may have chosen a drug that comes without the risk for permanent hair loss.
  2. Several studies showed the risk of permanent alopecia. Sanofi-Aventis provided doctors with materials that ignored the research, and this misleading information was passed on to patients.
  3. Hair really matters, especially for women. It plays a large role in identity. The stigma around hair loss makes it harder for cancer survivors to find employment. This is a direct economic consequence of permanent alopecia, for which Taxotere is responsible.

Other personal damages are harder to quantify, but are no less important. Hair plays a major role in personal, cultural and ethnic identities. Consider that Americans spend billions per year on hair products. In addition, many survivors simply don’t need a traumatic daily reminder of their battle with cancer.

What Research Has Proven

In 2012, The Annals of Oncology published a study of permanent hair loss in 20 women who had been treated with Taxtoere. The research confirmed that permanent and severe alopecia can result from Taxotere treatment. In addition to physical problems, the researchers documented psychological distress as a result of the hair loss.

Scientists built on these initial findings and presented the results to the National Cancer Research Institute (NCRI) in 2014. They reported 10 to 15 percent of patients treated with docetaxel for early breast cancer suffered long-term hair loss. Some participants could cope with wigs or hair extensions, but others also lost eyebrows and even eyelashes. These findings illustrate just how hard hair loss hits, especially for women who have already overcome a great deal.

With relatively recent research, questions remain for scientists to unravel. It is still not known precisely how common permanent alopecia results from Taxotere. An early study, in 2006, found that alopecia was more common when Taxotere was used with two other drugs: Adriamycin and Cyclophosphamide.

A Complex Symptom

That Taxotere is more harmful when combined with other drugs does not let drug makers off the hook. In fact, it shows exactly why pharmaceutical companies need to be more responsible with their labels. Complex interactions between drugs are exactly why medical professionals, patients and caregivers need clear, accurate warnings about any possible danger.

Permanent hair loss isn’t just a result of docetaxel, it’s a symptom of the callous and irresponsible attitudes that lead drug companies to take shortcuts when it comes to patient safety. It should not be up to corporations to decide which side effects are important enough to list on their labels. Patients have a right to decide whether they are willing to give up their hair or eyebrows, especially when there are other effective alternatives.

It is telling how long Sanofi-Aventis waited to rectify their misrepresentation of Taxotere. An updated FDA label was finally rolled out in 2015, warning patients that “cases of permanent alopecia have been reported.” How could it have taken nearly a decade to respond to the 2006 study at the Rocky Mountain Cancer Centers – especially when the new warning still downplays the risk?

Breaking the Cycle

Companies like Sanofi-Aventis respond only to profit. Dangerous drugs like Taxotere are billion-dollar carrots dangling before them. It takes a big stick to change their behavior. Sanofi-Aventis has previously gotten off easy for financial wrongdoing with the U.S. government.

Now, breast cancer survivors, in hundreds of ongoing Taxotere lawsuits, are seeking justice. In a perfect world, their actions would force pharmaceutical companies to value human health over quarterly profits. At the very least, these survivors might finally win justice and compensation for their physical and psychological suffering.

Topics

PAST ARTICLES