Drugmaker Sanofi-Aventis Kept Doctors in the Dark About Taxotere Hair Loss – But They're Blaming the FDA
“Carla” (not her real name) is grateful to be a breast cancer survivor. She knew that the chemotherapy treatments would cause her hair to fall out – but she never thought that hair loss would be permanent.
Even though she has been cancer-free for six years, she says, “People look [at me] and they have a sympathy look...I look like I have cancer.” It wasn't until she saw a social media post that she understood why her hair never grew back after her course of treatment was over. That post named Taxotere, the drug her oncologist used to treat her condition.
At first, Carla was angry at her oncologist for not offering her other options such as Taxole (currently, Taxotere is prescribed for approximately 75% of all breast cancer patients). However, now she says that she believes that “the drug company kept him in the dark about Taxotere causing alopecia.”
What is inexcusable about this situation is that Sanofi-Aventis, manufacturer of Taxotere, was fully aware of the side effect of the drug. In 2004 – five full years before Carla started treatments for breast cancer – the company did a study of its own product. The results showed that approximately 9% of all patients treated with Taxotere would suffer permanent hair loss. And yet, the company said nothing – to doctors and patients in the U.S., at least. Warnings were included in overseas markets (where, not coincidentally, drug companies and health care providers are much more tightly regulated and for-profit medicine is forbidden). But no warnings were provided in the U.S. until 2015.
What was the manufacturer's excuse? In response to a question from the media, Sanofi-Aventis blamed the FDA. A spokesperson for the company claimed that Sanofi actually did inform the FDA about the risk of “persistent alopecia” (permanent hair loss), but that the federal regulatory agency dragged its heels. The updated warning was finally issued in December of 2015, after “discussions” between the drug manufacturer and the FDA. However, the frequency of persistent alopecia has not been included on that label. Sanofi-Aventis is telling people who have been affected to take it up with the FDA.
Meanwhile, the FDA is saying very little, except that the process of updating warning labels is an “ongoing” one.So...who is responsible? While it is true that the FDA, an agency charged with consumer protection, has been compromised in recent years by ties to corporate interests, the fact remains that by its own admission, Sanofi-Aventis was aware of the risks and either neglected or willfully chose not to warn patients and doctors.