Annette Friedman

Annette Friedman, who sought access to an experimental monocolonal antibody drug that might have had action against her breast cancer, died in January 1997, shortly after the following was written.

A large number of women and men who know each other through an Internet mailing list but most of whom have never met one another and never met Annette Friedman, decided in November 1996 to move beyond dealing with their own medical issues and to become activists on breast cancer matters. They decided as their first action to try to help Annette, a member of the Breast-Cancer mailing list, to obtain the anti-HER2 monoclonal antibody.

In the process, they discovered flaws in the lottery set up by Genentech, INc., for distribution of their experimental medicine. These pages trace the Annette story; some of them include discussion of flaws in the clinical trials lottery, replies to those charges by the companies involved, and an analysis of those replies.

Annette's death will not have been in vain if, as appears possible, the activism engendered by her struggle turns into a major campaign to make information on clinical trials on breast cancer therapies more known to women and men and their doctors (much of it is only sporadically known and some of it is secret), more accessible to them, and fairer.

Legislation has been introduced in Congress toward the goal of a unified database of clinical trials information; activists are themselves seeking ways ot finding and organizing the available information as well. They hope that the Annette Friedman story, while the last chapter of her life, will be the first chapter of new levels of activism on breast cancer issues in North America.

John E. Bonine

Annette Friedman, a 58-year-old wife, lawyer and mother of two, is among the many breast cancer patients with advanced disease whose only hope is that a drug manufactured by Genentech, Inc., of South San Francisco will stop the growth of the tumors that are slowly killing them.

Last month, Friedman was sent home to wait to die, unless she can obtain the experimental treatment that might give her a chance to live.

Unfortunately, Friedman was told as recently as the third week in December that, once again, she would not receive the gene-therapy medicine that might give her a chance. There appear to be only two ways to get Genentech's anti-HER2 medicine, which has not yet reached the stage of final approval by the Food and Drug Administration. but which has shown anti-tumor activity in trials thus far.

The first way is through Genentech's regular Phase III trials.

The second is through a random lottery. But the lottery wheel was spun, and her number did not come up.

Originally diagnosed with Stage IV breast cancer (that which has spread to other organs of the body) in early 1995, Friedman tested positive last spring for the HER2 antibodies that Genentech's monoclonal antibody is designed to fight.

In the two years since her diagnosis, virtually every accepted chemotherapy treatment available has failed her. Last summer, Ms. Friedman's physician, Dr. Charles Vogel of Boca Raton, submitted her name to Genentech's monthly "lottery" to receive the drug outside of its ongoing phase III trials worldwide.

Annette has now competed 6 times in the monthly lottery, being randomized NOT to receive the drug each time.

Recently, a number of women with breast cancer and their friends and supporters from all over the world (including Europe and the Middle East) took it upon themselves to write letters to Genentech to ask that, given Friedman's dire straits and repeated good-faith attempts to get the anti-HER2 medication -- and because she has now been sent home in essence to die -- she be considered for a compassionate use allocation of the anti-HER2 medication.

Genentech's public relations department replied with a form letter. And the reply was, in essence, that they don't provide the drug as a compassionate-use exception, but only in trials -- and that, in their view, it would not be "fair" to give it out on any basis other than through the spin of the lottery wheel.

These World Wide Web pages are devoted to bringing as much information about this problem together in one place as possible. They seek to ask why, when Genentech's lottery has not been handing out all the supply that Genentech has available, the extra cannot be given to a physician on a compassionate-use basis as other drug companies do.

According to Genentech, "the HER2 proto- oncogene is altered in some patients to overexpress and produce excessive numbers of the HER2 cell-surface receptors. When this happens, cells divide, multiply and grow at a faster rate than normal cells -- and contribute to the development of cancer. The HER2 antibody was developed to block the HER2 cell-surface receptor by binding to it and neutralizing its function, thereby potentially inhibiting the growth of the tumor."

As Genentech puts it, women with "overexpressing" HER2 pro-oncogenes "exhibit disease that is much harder to treat. Cancer appears to spread to other parts of the body, or metastasize, at a rate that is faster than women with breast cancer who do not overexpress the HER2 oncogene. These women also have a greater chance of experiencing a recurrence of disease after receiving various standard treatments -- and they have a reduced chance for long-term survival."

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