Sanofi, European Regulators to Bald Breast-Cancer Patients: Drop Dead

Last Updated Mar 8, 2010 6:06 PM EST

Sanofi-Aventis (SNY) says it is "unable" to disclose how many women are rendered permanently bald by its breast cancer drug Taxotere and the European Medicines Agency (EMEA) says such data "are not routinely collected" even though small studies suggest that as many as 6.3 percent of patients lose all their hair forever.

Generally, drug companies are supposed to collect and disclose to authorities reports of adverse events linked to their drugs. If this isn't being done by either Sanofi or EMEA, then that raises worrying questions about the integrity of a system that's supposed to monitor the marketplace for dangerous drug side effects. A 6.3 percent rate would qualify for a "common or frequent" side effect designation by the Medicines and Healthcare Products Regulatory Agency in the U.K. -- and thus ought to be among the patient warnings for Taxotere.

Ever since Shirley Ledlie -- an Englishwoman now living in France -- went bald after using Taxotere to fight her breast cancer, she has corresponded with Sanofi and European medical authorities in an attempt to find out how common the condition is. BNET noted last week that the prescribing information for Taxotere gives no indication that there's a risk of permanent hair loss.

Ledlie wrote repeatedly to Sanofi asking the company if it had collected any reports of permanent hair loss. The company replied in 2008 that it knew of a study with 496 patients:
7 had prolonged significant alopecia at a median of five years follow up.
In 2009, after further letters from Ledlie, Sanofi wrote:
... we are unable to provide figures for the number of cases of alopecia associated with Taxotere reported into the company.
... the Medicines and Healthcare products Regulatory Agency (MHRA), the government agency which is responsible for medicines and medical devices work, publish complete listings of all suspected adverse drug reactions or side effects which have been reported by healthcare professionals and patients ...
I am afraid that there is nothing more we can do to help you with this chain of enquiry.
So Ledlie turned to the MHRA, which said :
With regards to the reaction 'alopecia' in association with docetaxel [Taxotere], the SPC currently states 'alopecia' to be a 'very common' side effect â€" occurring with an incidence of ≥1 in 10.
The MHRA added that it was aware of one study in which 22 of 687 patients (about 3 percent) had persistent baldness after nearly five years.

Ledlie also asked EMEA for the same information. That agency replied:
... we would recommend that you contact the marketing authorisation holder directly.
It can be said however, that the fact that figures about incidence of prolonged hair loss are not routinely collected does not mean that Sanofi Aventis do not keep records of spontaneous reports made to them by healthcare professionals.
However, the study cited by Sanofi in its early correspondence with Ledlie suggests that the rate of permanent baldness in women using Taxotere is actually far greater than 7 in 496 (or about 1 percent). The study, due to be presented by the Rocky Mountain Cancer Centers at a cancer conference later this year (see item 2105), found that all seven cases of long-term baldness occured only among patients taking Taxotere, according to an abstract obtained by BNET. As there were only 112 patients in that arm, the permanent baldness rate could be as high as 6.3 percent -- at the upper end of the MHRA's "common or frequent" designation.

Currently, Taxotere's prescribing information sheet says only that while "most" patients lose their hair during treatment, "hair generally grows back."

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