October 28 2002 letter to Wall Street Journal: Disclosure regulations keep the public out of the loop on all drugs
To the editor, Wall Street Journal:
Your September 24, 2002 editorial - “FDA to Cancer Patients: Drop Dead” - was an alarming title that outlined your paper's forecast that although Japan had already approved Iressa for desperately ill lung cancer patients, “the bureaucratic maze known as the FDA….seems ready to put process before patients.”
Today, you report that Astra-Zeneca, Iressa’s manufacturer is now reporting 39 Japanese lung cancer patients who have died - not from their lung cancer, but from the side effects of Iressa. Your editorial took the FDA to task for wanting better data before approving a new drug stating that wanting better data “isn’t a good reason and certainly not an ethical one for delaying approval.”
I am a cancer survivor and patient advocate, and I see at first hand the desperation that leads some cancer patients to therapies that may shorten their threatened lives. I have spent hundreds of hours helping cancer patients look for information about new drugs in development. In this search for “new” and “promising” drugs, it’s very hard to obtain facts on the problems that the experimental drugs may already have caused patients because drug companies keep those secrets to themselves. Even when they must report the negative side effects of their potential drug to the FDA, the FDA is bound by law to keep that information confidential.
Your September editorial stated that Iressa was a “new cancer drug that is helping desperately ill cancer patients…and is already approved in Japan.” Japanese patients are now dropping dead because the drug was approved. It looks like the Japanese regulatory authority, in its rush to approve Iressa, was not aware of some very important data that Astra-Zeneca was slow to submit to them. Whether or not it was aware of these data, it is clear that inadequate warnings were provided to doctors and their patients.
In the meantime, the FDA has not yet approved Iressa. Until there are some answers about why patients are dying from Iressa, I am satisfied that the FDA has the both the patient’s safety and potential benefit as their legitimate concern. Perhaps now it’s time for the WSJ to do a follow-up editorial entitled “Japanese Regulatory Authority to Cancer Patients: Drop Dead.” – since that seems to be exactly what is happening to some Japanese cancer patients who have taken Iressa.
Marti Nelson Cancer Foundation
As of February 7, 2004