The recent blog "Stand Up To Cancer Research!" described some of the pitfalls of modern cancer research and the clinical trial process. It has engendered an active discussion. It may be helpful to address some of issues raised. For those of you who did not have the opportunity to read that blog, it defined the difficulty that many patients encounter when they seek experimental treatments. Clinical trials are often only available at select centers, sometimes at great distances from patient's homes. There can be rigid inclusionary and exclusionary criteria, and the pre-entry evaluations e.g. re-biopsy, CT/PET, etc. can be daunting, time consuming and inconvenient. Travel and accommodations may come at great personal expense.
I penned the blog, in part, to remind patients that they are ultimately in control of the process. One patient asked how can “we stand up to the system” describing herself a consumer while "they've got the goods." This is the frustration many people feel. It should be remembered, however, that a substantial portion of research support comes from tax dollars and charitable donations. These are your dollars. If the system is not working, then those responsible must be held accountable. The American public has the power of the vote. Patient advocates can approach and lobby their representatives and demand improvements in the clinical trial process. To wit, the level of scrutiny and restriction upon access to new drugs must be re-examined. There is an army of well-trained clinical oncologists capable of delivering experimental drugs today. Not just the fully vetted, just-about-ready-for-prime-time agents currently found in phase III trials, but the really new exciting drugs. Once a drug has passed Phase I and found to be safe in patients, open up the accrual process. “Compassionate use” has virtually disappeared from the lexicon of cancer research. Twenty years ago I made a discovery in the laboratory. Working with the pharmaceutical company and the FDA, we were almost immediately granted access to a yet-to-be approved agent. The combination proved so effective that today it is one of the most widely used regimens in the world. That would not happen today. We simply cannot get access to the best drugs for our patients.
With the industrialization of medical care, growth of mega-medical systems and the increasing role of government, medicine must be viewed through a different lens. Changes in cancer research will require changes in cancer policy, and policy comes from political power. Cancer patients will need to identify legitimate spokespeople to take their concerns forward to their elected officials. While the current clinical trial process slowly grinds out new development, even the smartest, fastest trials take years to change practice. Every day, more than 1,500 cancer patients die in the United States alone. Cancer patients do not have time for clever doctors to pose interesting questions while they suffer the slings and arrows of ignoble, ineffective therapy. It is time for a change in cancer research, and patients must be the instrument for that change.