Breast cancer survivors are stepping forward, filing lawsuits against the manufacturer of Taxotere. In their claims, women allege that the company failed to warn patients and health care providers about the risk of permanent hair loss, also known as alopecia.
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Dozens of women have now filed lawsuits against Sanofi-Aventis, claiming the company’s breast cancer chemotherapy drug Taxotere causes permanent hair loss.
In Europe, cancer patients got a warning about this significant risk more than a decade ago. But the FDA only added warnings to the chemotherapy agent’s prescribing information in 2015. That’s a major problem, women say, one that Sanofi could have solved years ago – saving hundreds of women from the often severe psychological damage inflicted by permanent hair loss.
Today, legal experts believe hundreds of women who never regrew their hair after receiving Taxotere could be eligible to file lawsuits.
A decade of research suggests that between 6% and 15% of chemotherapy patients receiving the drug Taxotere may experience permanent hair loss, a form of alopecia that can have devastating psychological consequences, especially for the female breast cancer patients the drug is most commonly used to treat. Many patients, however, say they were never warned of this risk.
In a series of breaking federal lawsuits*, breast cancer survivors claim that Sanofi, the French pharmaceutical corporation behind Taxotere, actively concealed the drug’s link to “permanent disfiguring hair loss,” a cover-up they claim stretches back to the late 1990s. Perhaps more damning, Plaintiffs say Sanofi marketed Taxotere in violation of federal law, misleading physicians into prescribing the drug, which is far more toxic than its main competitor Taxol, by lying about its effectiveness.
Taxotere’s active ingredient, docetaxel, is one of several taxanes, a class of chemicals derived from plants like the yew tree. Paclitaxel, another taxane, has been used as a chemotherapy agent since 1992, when Bristol-Myers Squibb’s formulation of the chemical, branded as Taxol, was approved by the US Food & Drug Administration.
While both chemicals come from the same category of drugs, they are significantly different. Paclitaxel, for one, is far less potent than docetaxel, and thus Taxol is less toxic than Taxotere.
Toxicity is one of the primary aspects of a chemotherapy drug considered by physicians in making their prescribing decisions. In order to justify using a more toxic chemo agent, doctors will look for a markedly increased benefit, including increased survival rates. Balancing risks and benefits is essential to the practice of pharmacology.
Sanofi brought Taxotere to the FDA in 1994, two years before Taxol was approved. But the federal agency was worried about Taxotere’s incredibly high toxicity. Noting how little information was available on docetaxel side effects, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended denying Sanofi’s approval application.
Taxotere was eventually approved two years later, but only as a last-line treatment for patients with “locally advanced or metastatic breast cancer after failure of prior chemotherapy.” In other words, it was considered a last resort for patients living with intractable cancers.
But over the next decade, a series of favorable clinical trials, all of which were sponsored and funded by Sanofi itself, would open Taxotere’s approved indications to a far-wider group of patients. In time, Taxotere would be approved to treat patients with:
Finally, Taxotere was approved as an adjuvant treatment for women with operable breast cancers. Sanofi, however, did not stop at securing these additional approvals, according to former Taxotere patients. Using its favorable trial results, Plaintiffs claim, the company began to market Taxotere as a more effective chemotherapy drug than Taxol.
Post-market studies told a very different story, court documents report. Contrary to Sanofi’s claims of increased efficacy, patients say, “post market surveillance has shown that the more potent and more toxic Taxotere does not in fact offer increased efficacy or benefits over other Taxanes.” In 2008, for example, a study published by the New England Journal of Medicine found that paclitaxel, Taxotere’s main competitor, “improves disease-free and overall survival in women with breast cancer” more than Taxotere.
Sanofi chose to disregard this medical evidence, according to Taxotere lawsuits. Rather than accept the findings of researchers, Plaintiffs say, the company “continued to make false and misleading statements promoting the ‘superior efficacy’ of Taxotere.”
Ultimately, these apparent misrepresentations would catch up to Sanofi. In April 2009, the FDA sent Sanofi a warning letter, telling the company to stop circulating a binder of promotional materials (or “professional reprint carrier”) that made several “unsubstantiated” claims about Taxotere’s superiority to Taxol.
Sanofi’s promotional materials, according to FDA Regulatory Review Officer Keith Olin, cited a 2005 study as evidence that Taxotere could outperform Taxol in treating patients with metastatic breast cancer. That was “false or misleading,” in Olin’s words, since the study did “not constitute substantial evidence or substantial clinical experience to support th[ose] claims and representations because, among other factors, the study failed to demonstrate statistical significance on the primary endpoint and has not been replicated.”
But reports of Sanofi’s allegedly fraudulent marketing had actually surfaced far earlier.
In a Qui Tam (or “whistleblower”) lawsuit filed by the United States of America, former Sanofi sales representative Yoash Gohil accuses Sanofi of operating a “fraudulent marketing scheme.” Gohil, who worked in the company’s Oncology Sales division for more than 20 years, says Sanofi illegally promoted Taxotere for off-label uses.
Part of the manufacturer’s scheme, according to Gohil, involved paying “illegal kickbacks in the form of sham unrestricted grants, speaking fees, travel, entertainment, sports and concert tickets, preceptorship fees, free samples, free reimbursement assistance, and other things of value to physicians, hospitals and pharmacists in order to unlawfully promote the sale and off-label use of Taxotere.”
Sanofi even concealed its alleged off-label promotion “by making false statements to the FDA and directing employees to conceal evidence,” Gohil relates in the lawsuit, filed in the US District court for the Eastern District of Pennsylvania on May 17, 2002.
Returning to the words of one woman who has chosen to file a Taxotere lawsuit, Sanofi’s “fraudulent marketing scheme” worked. In 2001, the company earned more than $814 million in revenue from sales of Taxotere. By 2004, that number had increased by over 115%, to annual revenues of more than $1.75 billion. The cost to patients, however, went far beyond financial losses, according to Plaintiffs. As a direct result of Sanofi’s allegedly illegal marketing, “thousands of individuals [were] exposed to increased frequency and more severe side effects, including but not limited to disfiguring permanent alopecia (hair loss),” court documents report.
Like most chemotherapy drugs, Taxotere comes with a long, and often scary, list of side effects. It’s important to remember that no patient will experience every potential side effect of Taxotere, and that some of the drug’s effects can be predicted reliably in terms of their onset and duration. Patients receiving higher doses of the drug are likely to experience more side effects, and more severe side effects.
Common side effects, which occur in more than 30% of patients, include:
Less common side effects include:
Serious side effects include:
Current patients should contact their doctors immediately in the event of a severe Taxotere side effect.
While most chemotherapy agents, including Taxol, can cause hair loss, the side effect is usually temporary. Patients can often expect their hair to begin regrowing soon after treatment has ended. Sanofi, Plaintiffs write, led patients to believe that any hair loss caused by Taxotere would likewise be temporary.
In the drug’s original labeling, for example, the company appears to suggest that alopecia will end soon after a patient’s last treatment, addressing hair loss in these terms:
“Loss of hair occurs in most patients taking Taxotere (including the hair on your head, underarm hair, pubic hair, eyebrows, and eyelashes). Hair loss will begin after the first few treatments and varies from patient to patient. Once you have completed all your treatments, hair generally grows back.”
The label made no mention of permanent alopecia and, as you can see, implies that hair loss will end. That language remained unchanged from 1999, when Taxotere was first approved, until May 13, 2010. “Alopecia” was listed as a common side effect, but never one that could last forever.
According to recent lawsuits, Sanofi had evidence to the contrary long before 2010. As early as 2005, Plaintiffs write, one of the company’s own studies, titled GEICAM 9805, produced evidence that more than 9% of high-risk breast cancer patients administered Taxotere suffered permanent alopecia, with hair loss lasting up to 10 years and 5 months in some cases.
In 2006, an oncologist in Denver found that more than 6% of his own patients who had received Taxotere treatments experienced permanent scalp alopecia. Additional surveys of Taxotere patients have found that many women never regrew their hair.
These results, patients claim, were “knowingly, intentionally, and wrongfully withheld […] from physicians, healthcare providers [and] patients […] in the United States.”
European patients, along with Europe’s equivalent to the FDA, the European Medicines Agency (EMA), on the other hand, were not kept in the dark, Plaintiffs say. In the drug’s European product information materials, published no later than January 12, 2009, regulators make conspicuous mention of cases of “alopecia non-reversible” and “alopecia (persisting).”
Click here to view a version of the drug’s European product information published in 2009.
An even earlier document, which the EMA stopped updating on February 1, 2005, makes clear that European regulators were aware of permanent alopecia cases in 2005. In a “scientific discussion” held prior to Taxotere’s European approval, the document summarizes a safety study, titled TAX316, which compared Taxotere (TAC) to 5-fluorouracil (FAC) as adjuvant treatments for patients with operable breast cancer. By and large, the European officials found Taxotere’s toxicity troubling, and made note of its potential to result in persistent hair loss:
“With respect to long-term toxicity the profile of TAC is also unfavourable compared to FAC: Alopecia remains in 3.2% of TAC patients (vs. 1.4% FAC)” [emphasis added].
Similar information was not made public in the United States. But something strange occurred on May 13, 2010, one year after the European product information was publicized. The drug’s US labeling was revised to modify its approved patient population, but the paragraph cited earlier, which stated that a patient’s “hair [would] generally grow[…] back,” was also removed.
For the next 5 years, Taxotere’s US warning label made no mention of how long hair loss could be expected to last. That changed on December 11, 2015, when the FDA approved a change to the drug’s labeling, “add[ing] information on permanent or irreversible alopecia.”
Taxotere’s current Prescribing Information now includes 12 references to “alopecia” and 4 references to “hair loss,” many of which specify that cases of permanent hair loss have been observed.
For many women, including those who have already filed lawsuits, these warnings have come too late.
Plaintiffs have been careful to note that, where cancer is concerned, prescribing decisions are highly complex. Many women, they write, may “accept the possibility of permanent baldness as a result of the use of Taxotere if no other product were available to treat their cancer.” But as we’ve seen, that isn’t the case: paclitaxel has been found more effective than docetaxel.
If Sanofi actively concealed evidence of Taxotere’s link to permanent alopecia, patients were deprived of that valuable information. Women say they would have chosen Taxol, a drug with:
rather than Taxotere.
In the words of one Plaintiff, “as a direct result of Defendants’ wrongful and deceptive acts, thousands of women were exposed to the risk of disfiguring permanent alopecia without any warning and without any additional benefit.”
*Carson v. Sanofi S.A. et al. Filed in the US District Court for the Northern District of Ohio on January 22, 2016. Registered as case number 1:16-cv-00165-CAB.
Dodson v. Sanofi S.A. et al. Filed in the US District Court for the Northern District of California on March 14, 2016. Registered as case number 4:16-cv-01251-PJH.