Cancer Drug Label Warnings Do Not Reflect Patient Experiences: Study

The findings of new research suggest that the warnings and labels provided about potential side effects of many cancer drugs do not actually match the experiences of patients who receive those medication. 

In a study published last week in the Journal of Clinical Oncology, researchers from RTI Health Solutions in North Carolina found that few drug warning labels approved in the U.S. include patient-reported outcomes (PROs), resulting in a potential disconnect between what the labels warn could happen and what patients actually experience.

Researchers looked at FDA Drug Approval Reports by Month for a number of new drugs from 2010 to 2014, focusing on cancer drugs. They looked at the label warnings, FDA reviewer feedback, drugs given fast-track approval, and patient-reported outcome data.

The study narrowed the drugs down to 40 molecular entities and biolotic license applications approved by the FDA Office of Hematology and Oncology and found that only three, or 7.5%, received patient-related outcome labeling, including Zytiga, Jakafi, and Xalkori.

Researchers also discovered that cancer drugs were more likely to be fast-tracked as “orphan drugs” with minimal clinical trials, and the first in their class.

Drugs approved through the Orphan Drug Act are designed to treat deadly conditions that only impact a limited population. However, a study by researchers at Johns Hopkins reported last year found that pharmaceutical companies are “gaming the system” and using the law to approve mainstream blockbuster drugs that are then promoted and prescribed for uses never approved by the FDA.

Researchers say that in 2014, approximately 41% of new drugs approved by the FDA were introduced via the Orphan drug law. Many of these drugs move on to become blockbusters, with more than $1 billion in sales. However, the law, originally approved in 1983, was meant to help drug manufacturers introduce medications that would otherwise be unprofitable, granting special patent protections and a faster route to the market, in situations where they would help 200,000 patients or less.

The law grants the drug seven years market exclusivity, tax breaks in the millions, and waives the millions of dollars of marketing application fees.

Taxotere Hair Loss

One recent example of a cancer drug whose label warnings do not appear to match the side effects of many of its users is the chemotherapy drug Taxotere, which has been linked to reports involving permanent hair loss following chemotherapy, despite warnings that indicate hair generally grows back.

Taxotere (docetaxel) was approved by the FDA in May 1996 for treatment of breast cancer, which is given by injection with other chemotherapy drugs. It is used for treatment of patients with locally advanced or metastatic breast cancer after prior chemotherapy attempts had failed, competing with several other treatment alternatives.

Allegations raised in recent Taxotere alopecia lawsuits indicate that AstraZeneca knew or should have known about the risk of permanent baldness following chemotherapy treatments with their drug, yet misleadingly indicated the hair loss side effects were temporary, like other cancer drugs. However, patient experiences have not matched these indications.

In 2005, a study known as GEICAM 9805 found that 9.2% of patients who took Taxotere experienced long-term hair loss for up to 10 years and five months, and in some cases longer. This study was sponsored by Sanofi-Aventis, yet plaintiffs claim information about the permanent hair loss risk was withheld from consumers and the medical community.

Reports of Taxotere hair loss problems were also submitted to the drug maker by medical providers. In 2006, at least one Denver-based oncologist reported that 6.3% of patients he treated with Taxotere suffered permanent hair loss for years after taking the drug.