MIF makes the trek to Chicago for ASCO (American Society of Clinical Oncology) where each year more than 25,000 cancer researchers attend the conference to share and learn about therapy discoveries. We go to learn what we can for you, our patients and caregivers. The size of the corporate display booths are always a shock when you think of that money being spent elsewhere, but this is big business and the competition drives the results that hopefully will benefit you. Much of the research is embargoed (not made public) until ASCO. So that builds the excitement of the meeting. That’s all been published by now and so I want to discuss the mission that charged me up when I returned from Chicago.
So forget the money and the business end and think how did these drugs get developed? Because you, the patient, volunteered to put up with a lot to make this research go forward. Clinical trial design has not changed for 55 years and it shows! At ASCO this year, I was a fortunate advocate to be invited to convene for a short hour with the FDA team that works with oncology. Here are the issues I spoke personally with the FDA oncology group about and other issues presented by advocates at the table.
• Stage III: As we all know, most therapies work best with a small burden of disease. Why wait until a person progresses to stage IV and then try these therapies?! Finding melanoma early and treating it has the best outcome. We know from pathology reports and SLNB who is going to progress. Treat them early, don’t watch and wait until they become stage IV.
• Placebos: Oh please don’t tell me we don’t know when a drug works and the mind can cure cancer. Placebos are downright inhumane. Most trials with them don’t accrue patients anyway.
• Lousy Comparators: Please, no more interferon or dacarbazine to be randomized to. Patients will simply drop out if they get these drugs because they have little promise for melanoma and they can get them prescribed anyway.
• Blinded trials: People and researchers aren’t stupid, they know what folks are getting by exhibiting side effects and sometimes it slips from the attending nurse (as it did for one patient I worked with) Let’s keep the trials honest and open. Again, if the drug works, you will know it!!
• Brain Mets Exclusion: This just isn’t fair to the patient. Are we worried more about the trial outcome than the patient outcome?
Better trial design is possible and can be a reality. The FDA, pharma and patients and advocates need to work together to end these unfortunate designs and create humane, fast moving designs that get the drug that works to the patient who needs it.
I intend to follow up and I hope to make progress in this quest. I’ll keep you informed. We’re on our way to some pretty exciting therapies for melanoma and please remember without you, the patient, we wouldn’t be anywhere at all!