Following is the text of a letter sent by Genentech, Inc.'s public relations department to about 40 women who sent individual letters to the company asking for an allocation of its experimental anti-HER2 medicine to be made to Annette Friedman of Florida on a compassionate-use basis.
From: "Laura Leber" - leber@gene.COM
Date: Thu, 19 Dec 1996 11:52:49 -0800
Subject: ANTI-HER2 EXPANDED ACCESS
We received your e-mail regarding access to the anti-HER2 antibody for Annette Friedman.
We are so sorry to hear about Ms. Friedman's long struggle fighting breast cancer and realize the importance and urgency of developing new treatments for this terrible disease. Many dedicated people at Genentech have spent many years studying ways to target and defeat this and other life-threatening diseases.
Once early Phase II studies showed that the HER2 antibody might hold promise in treating breast cancer, we rapidly designed and began Phase III trials to demonstrate whether the drug is effective and safe. These Phase III trials are ongoing. We also worked with breast cancer advocates to set aside a portion of what remains an extremely limited supply of the drug for patients who are ineligible for our Phase III trials and who have very few other treatment options. Given the limited drug supply,we agreed with breast cancer advocates that a completely impartial selection process must be put in place that gives each participant an equal chance to receive the drug, and therefore we implemented a randomized lottery. We also agreed that patients should be able to re-enroll every month rather than every three months.
Because there is more demand than supply for the drug from patients outside our Phase III protocols, some patients have been randomized not to receive drug, like Ms. Friedman. This is an unfortunate reality of a limited supply of drug. Despite this, I hope you can see how making exceptions is not equitable to current and future breast cancer patients who participate in the lottery.
We have been open to discussions with patients and patient advocates regarding other lottery protocols, however to date no other system has offered the same impartiality and equity as the current one. We will remain open to proposals from you and your group and will share them with the breast cancer advocates who authored the current lottery system so they can provide feedback.
Vice President, Medical Affairs
Genentech Corporate Communications