A patient who undergoes chemotherapy for the treatment of cancer can expect hair loss, among other side effects. That loss can include scalp, facial and body hair. In most cases, hair grows back approximately three to six months following the completion of treatment, but in the case of Taxotere, hair loss can be permanent – as many patients have discovered after it was too late. This was a side effect that drugmaker Sanofi-Aventis neglected to mention to physicians who recommended Taxotere to their patients.
In fact, Sanofi-Aventis engaged in an aggressive marketing campaign for Taxotere, making claims that it was safer and more effective than other chemotherapy medications, such as Taxol. This drew scrutiny from the U.S. Food and Drug Administration in 2009, which accused the company of misbranding. The FDA subsequently sent a warning letter to the company requesting that it cease and desist from distributing marketing material that “presents unsubstantiated superiority claims and overstates the efficacy of Taxotere.” A few years later, in 2014, the FDA issued a warning that treatment with Taxotere could cause symptoms of alcohol intoxication during and following treatment.
Last year, the FDA responded to reports of permanent hair loss (persistent alopecia), announcing that Taxotere would include a package warning. What is interesting is that Sanofi-Aventis conducted its own study in 2006, the result of which indicated that roughly three percent of patients treated with Taxotere would suffer permanent hair loss. However, subsequent studies showed this figure to be inaccurate. That same year, a follow-up study carried out at the Rocky Mountain Cancer Centers demonstrated that more than six percent of women who underwent breast cancer treatments with Taxotere experienced the loss of at least half of their hair. The effect was even worse when Taxotere was administered in combination with other chemotherapy drugs such as Adriamycin (doxorubicin).
Current allegations by plaintiffs who have filed lawsuits state that Sanofi-Aventis was aware of these risks and failed to issue adequate warnings – whether by oversight or design. If the drugmaker deliberately withheld this information from physicians, it is easy to understand why: Taxotere sales in 2009 alone totaled more than $3 billion. It is a sad, yet all-too-common scenario in Corporate America. The executives and company accountants get together and do a cost analysis in order to determine if the potential for massive profit outweighs the risk of having to pay out judgments. In most cases, it is decided that paying a few settlements and penalties is simply part of the cost of doing business.
In the meantime, what happens to those who have been injured? Although hair loss in and of itself is not life-threatening, it can have devastating psychological consequences that affect self-esteem, ability to engage in employment, and relationships. Depression and social isolation is not uncommon – both of which can eventually manifest themselves as health issues.
In addition to legal action, those who have suffered as a result of treatments with Taxotere can find help and emotional support from A Head of Our Time, a ten-year-old online support group for patients who suffer persistent alopecia