Eight-Year Wait for Authorization of Drug That Treats Rare Cancer

12/08/2016 - 13h27

A stalemate that has lasted eight years has prevented the registration in Brazil of the drug lenalidomide, used in the treatment of multiple myeloma, a type of cancer that attacks the bone marrow and affects some 30,000 people in the country.

The drug has already been approved in more than 70 countries. Without the registration, neither Brazil's public health care system nor health insurance companies agree to supply the drug as federal law prohibits the supply of medicine without the authorization of the country's regulating agency, Anvisa.

The stalemate has made patients try to obtain the lenalidomide through court orders. Brazilian judges normally consider that there is no other therapeutic alternative and tend to grant injunctions favorable to patients.

A survey by Folha showed that there are at least 651 lawsuits involving the substance whose proceedings have reached the second instance in the country's courts. A 25-miligram pill costs R$ 1,426 (US$ 407,43). A six-month treatment would amount to some R$ 257,000 (US$ 78,570).

"Bureaucratic issues regarding Anvisa should not prevent patients from obtaining a drug that could save their lives," says lawyer Rafael Robba. In the past two years, the office where Robba works began 13 lawsuits requesting the drug.

Anvisa says that the delays in registering the drug occurred because of problems in the documents supplied by its producer, Celgene.

DELAY

Lawyer Rogério Oliveira, 46, was diagnosed with multiple myeloma in December 2012, after months of pain and a numb feeling in his feet. After undergoing a bone marrow self transplant, doctors prescribed lenalidomide and Oliveira obtained the drug through an injunction in 2013.

"Even with the court order, it took me six months to obtain the medication. Every 21 days, I had to get a new box with the drugs and it never arrived on time," says Oliveira. In December 2103, his exams showed that the disease was under control and the use of lenalidomide was suspended.

Translated by THOMAS MUELLO

Read the article in the original language