The growing number of Taxotere® lawsuits against Sanofi-Aventis have people asking a lot of questions. Seven of the most important questions are identified and answered below.
1. What Is Taxotere?
Taxotere (docetaxel) is a chemotherapy agent manufactured and marketed by the French pharmaceutical company, Sanofi-Aventis. Approved by the Food and Drug Administration (FDA) in 1996, Taxotere is used typically to treat breast cancer, but it has since been expanded to include the treatment of head and neck cancer, gastric cancer, prostate cancer, and non-small cell lung cancer. It is the most prescribed drug in its class.
2. Does Taking Taxotere Cause Permanent Baldness?
One of the most common and distressing side effects of chemotherapy is temporary hair loss. Normally, the disfiguring effects of the drug are reversible, with complete hair regrowth occurring only a few months after treatment. A growing number of patients who took Taxotere, however, have been devastated by permanent hair loss. In December of 2015, after 19 years on the market, Sanofi-Aventis finally changed the warning label to indicate that the drug has been linked to permanent hair loss, also known as permanent significant alopecia, or PSA.
3. How Long Did Sanofi-Aventis Know about the Risk of Permanent Hair Loss?
In the late 1990s, Sanofi sponsored a study which, by 2005, demonstrated that 9.2 percent of patients who were treated with Taxotere had PSA for up to 10 years. In 2006, a study published by an oncologist at Rocky Mountain Cancer Centers found that the risk of PSA from Taxotere could be as high as 6.3 percent. That same year, Sanofi’s own study concluded that 3 percent of women would experience PSA. In 2014, a study in the U.K. found that PSA may affect 10-15 percent of patients who use Taxotere. The results are varied, but 1 thing is clear: Permanent hair loss is undeniably linked to the use of Taxotere – and it is not uncommon; in fact, it happens much more often than the Big Pharma company lets on.
4. Did Sanofi Warn Patients of the Risks of PSA?
Since 2005, warning labels in Europe have told consumers about the potential of permanent hair loss associated with Taxotere. This warning did not appear on the drug labels in the United States until 10 years later. Sanofi was aware of the risks and they chose to withhold this vital information. Despite a growing body of research, Sanofi continued to tell U.S. physicians, healthcare providers, and patients that their hair would generally grow back. It makes no sense to alert only some of your patients that a drug is known to potentially cause life-altering disfigurement.
5. Does That Mean 10 Years Passed before U.S. Customers Were Warned at All?
Yes, it does.
6. What Was Sanofi Doing Instead?
As if downplaying the risks of Taxotere at the patient’s expense wasn’t bad enough, Sanofi also aggressively marketed the drug to outsell alternative drugs in the breast cancer chemotherapy drug market. It didn’t matter to Sanofi that some of these alternatives, like paclitaxel or Taxol®, had less or no risk of PSA – what mattered was profits, and so Sanofi engaged in deceptive practices to make Taxotere appear as the clear number 1. In 2009 (the same year Sanofi paid over $100 million to resolve False Claims Act violations), the FDA also accused Sanofi of overstating the superiority of Taxotere and making unsubstantiated claims about the drug.
7. What Are the Consequences?
The disfigurement suffered by people who took Taxotere is irreversible and shocking – for many American women, the risk of PSA was something they were not told. Now, after beating cancer, these women will have to deal with mental anguish, depression, anxiety, and devastated self-esteem for the rest of their lives.
It did not have to be this way. Sanofi knew of the risks, and instead of warning physicians and patients, they puffed up their drug with a smokescreen of dubious claims. Many of the patients using Taxotere were women who deserved to have the same information Sanofi had. Through their actions, Sanofi robbed too many women of the right to a choice.
It is simply unacceptable for pharmaceutical companies to withhold information like this. It deprives people of the ability to make an informed decision. Patients have a right to all of the information. It is people, and not profits, that Sanofi should start looking out for.