I was diagnosed with Stage 4 prostate cancer in November of 2008. After discussing the options with my family, I decided to try clinical trials instead of following the standard course of treatment. My first clinical trial combined 6 rounds of chemotherapy with the standard hormone replacement therapy (editors note – ADT). This trial was effective for about 20 months before my PSA began to again rise.
In the fall of 2010 my family and I were once again trying to decide the best course of treatment. I was able to enroll in a trial for MDV-3100, now known as Xtandi. I responded extremely well to this drug for about 34 months.
When I the drug started to be become less effective, my doctor recommended a new Phase I trial sponsored by Genentech, Inc. This trial is to test the effects of GDC-0068 along with enzalutamide (Xtandi) on metastatic prostate cancer. This seemed to be a logical next step since Xtandi had worked so well.
I underwent the medical testing to qualify for the trial. I was then informed that Genentech would only pay for GDC-0068 but would not pay for the Xtandi. My cost for Xtandi would be over $9,000 dollars a year. I would like to point out that this is apparently allowed because of a loophole in the clinical trial system.
According to my doctor, if Xtandi was a drug administered in the doctor’s office, then the company would be forced to pay for the drug on the trial. However, since it is a pill taken at home, the cost of the drug would be my responsibility. I did not qualify for co-payment assistance.
My situation raises serious questions about the financial resources required to participate in a trial. As more and more trials look at the effectiveness of drug combinations, patients should not face the choice of not participating in the best trial for their cancer because of costs. The drug companies are testing the effectiveness of the two drugs together but may only pay for one of the drugs on the study. Yet, they need the data from the drug combination. This system should not prevent people from enrolling in trials because they must shoulder the cost of the drugs required for the company to collect the data necessary for their drug approval.
While the above situation causes serious questions about the financial resources required by trial participates in this study, I believe that it also raises serious ethical dilemmas regarding participation in drug trials. If drug companies desire to develop data to help develop sales of new drugs, then it would seem incumbent upon the companies to furnish the drugs needed to develop these data. If the purpose of this particular trial is to determine any synergistic effect such as between Xtandi and GDC-0068, then the trial is to develop data on what is essentially one drug, not two.
Genentech should recognize that it is not right to ask participates in trials to suffer serious financial penalties to develop data for them to potentially use to sell their drugs.
Name Withheld by Request
I would like to thank the author and his family for sharing this experience and the issues they have bumped up against. They have asked not to use their names as they are continuing to look for ways to participate in the trial and don’t want to jeopardize their chances.
Men who chose to participate in trials are not only looking for the best personal treatment, but they are making a commitment to the rest of us to further the treatment options that are available to us all. They do this with full knowledge of the risks they might be encountering. Men like this author are true everyday, unsung heroes and we all are obligated to them for their courage.
They have brought to our general attention a hidden problem that will clearly discourage people from participating in trials. It is shocking how many trials are never completed because of a failure to enroll enough subjects. Pharmaceutical companies stand to make significant profits, but they need to be responsible to support the heroes who are risking their health and their life. Pharma must be ready to make the financial investment to be able to reap the economic rewards.
*** I would like to invite anyone who wishes to share their story, their experience and their insights into this disease. Please forward to me (Joel@Malecare.org) anything you would like for me to consider publishing in this blog. You don’t need to be a hero, just have an interesting story or an insight that would be of interest or help to others.
Joel T Nowak, M.A., M.S.W.