U.S. Women Warned a Decade Late
French drug maker Sanofi-Aventis waited until December 2015 to warn U.S. cancer patients and their doctors about the risk of permanent alopecia from the company’s cancer drug Taxotere. And even at that late date, the company added the warning only after the U.S. Food and Drug Administration ordered it to do so.
Sanofi-Aventis began to warn patients in Europe and Canada back in 2005 about permanent hair loss from Taxotere. U.S. doctors and their patients, meanwhile, were at least for a decade unaware that Taxotere raised the risk of permanent alopecia. Americans were also unaware of an alternative chemotherapy drug that is just as effective, and is safer and less expensive – Taxol, made by Bristol-Myers Squibb. Taxol also comes without Taxotere’s “side effect” of permanent hair loss or complete baldness, which can hardly be called a mere side effect when it represents a permanent condition.
Sanofi-Aventis fined $109 Million in Qui Tam Lawsuit
Sanofi-Aventis’ deceitful, duplicitous marketing of Taxotere comes on the heels of criminal behavior for which the company has been held accountable in the past. Sanofi-Aventis was ordered in 2012 to pay an enormous fine stemming from criminal behavior used to hoodwink the public and boost profits.
Sanofi Agrees to Pay $109 Million Fine for False Claims, Kickbacks
The U.S. Justice Department web site stated Dec.19, 2012 that Sanofi-Aventis U.S. Inc. agreed to pay $109 million to resolve allegations that Sanofi US violated the False Claims Act. The company paid for a scheme in which it used physicians to file false reports which were used to set reimbursement rates that caused government programs to pay inflated amounts for Sanofi products.
The United States contended that Sanofi faced pressure from a lower-priced competitor, so the company trained its sales representatives to manipulate the market. The U.S. Justice Department said, “Sanofi US sales representatives often entered into illegal sampling arrangements with physicians, using the free units as kickbacks and promising to provide negotiated numbers of them in order to lower Hyalgan’s effective price. The government contends that there were numerous such arrangements.”
Taxol, The Safer Alternative
Taxotere Lawsuits brought by women suffering permanent hair loss will all point out that a safer, better, alternative drug was available when the victims were prescribed Taxotere by unwitting medical personnel. Taxol is derived from more natural means than Taxotere, which is twice the strength of Taxol. It is too strong, in fact, as its strength seems to be the mechanism that permanently kills hair follicles, leading to permanent baldness.
Taxotere’s Misleading Promotion
Taxotere (docetaxel) has been vastly promoted by Sanofi-Aventis as a newer, more effective alternative to Taxol (paclitaxel). Since its 1992 approval, the older chemotherapy drug Taxol (made by Bristol-Myers Squibb) has been one of the most widely used drugs in the adjuvant treatment of breast cancer. Taxol has been supported by high-quality evidence in the scientific literature that prove its safety and effectiveness. Comparison between the two medications proved them to be nearly equivalent; however, Sanofi kept claiming docetaxel superior to paclitaxel in early advertising campaigns. The advertising blitz apparently paid off, as Taxol use has progressively fallen in the last ten years, while Taxotere has gained substantial market share, despite its higher price.
Women not warned of Permanent Hair Loss – Cancer Drug
In April 2009, the FDA accused Sanofi of overstating the efficacy of Taxotere by giving the doctors and patients misleading promotional material that included unsubstantiated superiority claims. In its warning letter, FDA highlighted that no clinical experience ever provided substantial evidence about the fact that docetaxel was safer, better or more effective than paclitaxel. Sanofi falsely claimed that Taxotere was associated with significantly higher response rates, longer duration of response, longer median overall survival compared to its competitor, Taxol. Sanofi cited a study in support of these claims that FDA deemed insufficient, ruling that the study failed to demonstrate statistical significance and was never replicated.