Despite my request for information substantiating the assertions made
in the NCGS prepared statement, Vice President Boyce wrote back to me
to say that "NCGS and Genentech have made available all the information
we believe is relevant regarding the lottery." I still wonder, what's
the big secret, regarding when adjustments are made? So I wrote
again.
Dear Ms. Boyce:
On Tue, 28 Jan 1997 ncgs_is@awod.com wrote:
> Mr. Bonine:
>
> It is unfortunate that you still do not seem to be satisfied with the
> information provided regarding the lottery system and that inaccurate
> information continues to appear on your website.
Ms. Boyce, I am endeavoring to make that information as accurate as possible. That is why I have asked for clarification and documentation. It appears to me that you have simply asked that I take your latest position instead of the earlier position (and Genentech's own statements about making adjustments on a monthly basis) at face value, and I honestly don't know the basis on which I should accept the latter as valid. Please help me understand how often you make adjustments in the algorithm or assumptions used in the computer program.
I recently found the following from your Informed Consent form for this trial:
"If I am eligible to participate in this trial, I will be randomly selected for participation assigned by chance (by lottery) to receive a dose of 4 milligrams of rhuMAb HER2 for every kilogram I weigh. This lottery selection is needed since there is a limited supply of the antibody and if I do not get selected I will be placed in the lottery for the next month. My chances of getting selected to receive treatment will depend on the number of patients eligible for this study at other trial centers."
This statement that the odds depend on the number of patients whose names are submitted to the lottery nationwide is PRECISELY a statement that the odds change from time to time. Is it not? It does not state that the odds are based on a single odds ratio for all time, but on "the number of patients eligible." This means that as fewer or more patients apply and are deemed eligible, the chances (odds) of getting the drug will increase or descrease. But when are these adjustments made?
Please help me understand why this Informed Consent form doesn't contradict the suggestion that adjustments are not made.
> Although it is not required of companies, Genentech has allotted a
portion
> of what remains an extremely limited supply of drug for use by
seriously ill
> breast cancer patients. A lottery system is used to allocate the drug,
and
> all possible efforts have been made by Genentech and NCGS to ensure
that the
> study is conducted 1) with the utmost fairness for all patients, and 2)
with
> a response as to whether a patient will receive the study drug in the
most
> expedient timeframe possible.
Ms. Boyce, since you have now limited the assertions to these two -- that the study is fair and responses to individual patients are expeditious -- am I to assume that, after receiving my recent comments about when adjustments are made, that you agree with my reading of your previous message, in which I summarized your position as: you deny that adjustments in the odds ratio are made at the end of the quarter; you claim that adjustments are not made daily; Genentech has told people that adjustments are made monthly; and therefore adjustments are indeed made on a schedule that lies somewhere between daily and quarterly? Since you did not deny that summary in my previous message, but omitted the topic in this message, is this what I am to conclude?
> NCGS and Genentech have made available all the information we believe is
> relevant regarding the lottery. NCGS and Genentech stand by the
efforts
> made in this area and will continue to make our best efforts to serve
cancer
> patients.
I applaud your and Genentech's efforts to serve cancer patients. The work is worthwhile, humanitarian, and potentially beneficial to Genentech as well.
I do recall, however, that the negotiators asked for a review of the lottery after a year. Are there any plans to involve breast cancer activists in looking over the lottery details, even if you don't want to do that publicly?
> Thank you.
>
> Gail G. Boyce
> Vice President, Operations
Thank you, prospectively, for clarification of these points so that I can post something that does not embarrass you.
John E. Bonine
The problem is that we can't really tell if they make the adjustments the way they now claim to do so, or the way they described it to me a month ago in that first phone call.