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Women across the country are beginning to file lawsuits over a chemotherapy drug they say causes permanent hair loss. It’s called Taxotere, and many patients, including the women at Ahead Of Our Time, claim they were never warned of this traumatic side effect.
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In the drug market, Taxotere has one big competitor: Taxol, a chemo agent manufactured by Bristol-Myers Squibb. Both drugs are taxanes, a class of chemicals originally derived from a family of small pine trees. But Taxotere is potent, far stronger, and more toxic, than Taxol. In fact, Taxotere’s approval was delayed for two years because FDA researchers worried about how toxic it would be for patients.
When Taxotere was finally approved in 1996, the FDA restricted its indications to just one group of patients: people with “locally advanced or metastatic breast cancer after failure of prior chemotherapy.” Apparently, the FDA thought of Taxotere as a last-line of defense. But since 1996, the drug’s approval has been extended to cover patients facing head and neck cancers, lung cancer, prostate cancer and gastrointestinal cancer, too. Finally, Taxotere was approved as an adjuvant therapy for patients with operable breast cancer. Those additional approvals came despite the FDA’s early concerns over Taxotere’s toxicity, and the findings of medical researchers, who discovered that Taxol actually improved patients’ survival rates more than Taxotere.
In 2001, Sanofi, the French multinational corporation behind Taxotere, raked in $814 million in sales of the drug. Only three years later, the company’s revenues from Taxotere had exploded by 115%, to over $1.75 billion. Yoash Gohil, a former sales representative at Sanofi, had an explanation for that surprising increase. In a federal whistleblower lawsuit filed in 2002, Gohil accused Sanofi of orchestrating a “fraudulent marketing scheme,” one he claimed was meant to convince physicians to use Taxotere for off-label purposes. Gohil’s case is still in court.
Taxotere wasn’t approved for sale in Europe until 2005, but European reviewers were busy analyzing the drug’s safety and efficacy data. What they found was troublesome. In an extensive report, published when the drug was finally approved, European scientists noted Taxotere’s “unfavourable long-term toxicity,” mentioning clinical trials in which alopecia had persisted among some patients.
But similar information wasn’t publicized in the US. In 2009, Taxotere’s US labeling simply said, “hair generally grows back,” language patients say strongly implied that, just as with every other chemo agent, people on Taxotere shouldn’t worry about losing their hair permanently. That same language had been there since the start. The warning never mentioned the possibility of a patient’s hair loss lasting forever. In their lawsuits, Plaintiffs say that Sanofi should have listed permanent alopecia prominently on Taxotere’s warning label, citing early clinical trials they claim uncovered evidence that over 9% of patients taking the drug hadn’t regrown their hair up to 10 years after treatment.
Independent researchers had also found evidence of permanent hair loss in Taxotere patients. In 2006, an oncologist in Denver performed his own study, reviewing hair loss in patients who had been administered chemotherapy agents. Permanent alopecia was only observed in patients who had received Taxotere, and the condition was far more common than anyone had previously thought possible.
Among patients who had been given Taxotere, 6.3% had experienced persistent alopecia up to 7 years after treatment. Worse, none of the patients who had undergone treatment with Taxotere’s competitor, Taxol, had experienced permanent hair loss, even though his study looked at more Taxol patients than Taxotere patients.
Between 2006 and 2011, Taxotere won a series of new approvals, picking up patients with gastrointestinal cancers and squamous cell carcinomas of the head and neck. But something odd happened in the course of all these new approvals, which require significant labeling changes. The note about hair loss on Taxotere’s warning label disappeared. Remember that the drug’s labeling read “hair generally grows back.” That language simply vanished on May 13, 2010, in the midst of a totally-unrelated labeling change. There’s no publicly-available FDA document explaining why the note about hair loss was removed.
In 2011, a group of European dermatologists published a report on chemotherapy-induced permanent hair loss. It’s a very rare condition, so rare that the doctors weren’t sure they would find any registered cases in their own records. True to form, their analysis of more than 8,400 patients turned up only 7 people who had experienced permanent alopecia after chemo. 5 of those patients had been given Taxotere. The other two had received busulfan, one of the only chemo agents known to cause persistent hair loss.
Between January and March of 2011, Taxotere was the 57th best-selling drug in America, according to data from Drugs.com. But Sanofi’s market dominance couldn’t last forever. On March 8, 2011, the first generic version of the drug’s active ingredient, docetaxel, was approved for sale in the US. Three other generic equivalents would be approved the same year, with six more on the way over the next five years.
In 2014, a new paper added support to the evidence that Taxotere can cause permanent hair loss. In a survey filled out by 134 former Taxotere patients, all of whom had been treated for early-stage breast cancers, researchers in the UK found that up to 15% had experienced “significant persistent scalp hair loss” more than 3 years after the end of treatment.
While the doctors were shocked by how many patients reported permanent hair loss, the fact that Taxotere could cause the condition wasn’t particularly surprising. At least, not in Europe. In fact, European researchers had been pointing to Taxotere as the cause of permanent alopecia for years before that.
But it was only in 2015 that the FDA finally woke up. On December 11, the agency approved a new labeling change, adding references to the possibility of permanent alopecia. Notes on persistent hair loss are now included in documents intended for health professionals, as well as those for patients. Women who have already experienced permanent hair loss say those improvements came too late.
