Monday, January 21, 2013
Cancer Research Today
by Carol Westbrook
The Golden Age of cancer research is here. The Human Genome program provided rapid sequencing tools and large databases to be mined, computers are larger and faster than ever, advances in equipment and robotics make high-throughput experiments possible, the info web permits quick literature searches.... and so on. Cancer patients are out there, digitally connected and eager to participate in clinical trials. An increasing amount of private and public monies are going into the research effort. We are poised to make great discoveries at a rapid pace, and bring them rapidly to the clinics.
So then, why are these anticipated advances in cancer treatment so slow in coming? What is wrong with cancer research today? Well, pretty much everything.
Cancer research has two sides to it: the basic science laboratory at the university, where ideas are generated and potential new treatments are designed, and the clinical research program, where these new drugs are tested on patients and developed into bona fide treatments which are then brought to the FDA and eventually the marketplace and clinic. There are inefficiencies and major barriers to productivity in both the basic and clinical arenas.
Laboratory research is terribly expensive, and relies primarily on government funding, though an increasing amount comes from private donations and foundations. Yet only a fraction of these research dollars are truly used for researc, as the university is permitted to keep a large share as "overhead" for its own use. Admittedly, these dollars support the teaching mission of the university and contribute to our country's education, but that's fewer dollars spent on cancer research.
There is intense competition for these research dollars, and the competition itself is costly, requiring large infrastructures merely to submit and review grants. One's success in academics relies on getting the most grant money, rather than on the productivity that results from the grant.
Grant funds tend to be controlled by a select few of the "old boys," with the result that creativity is stifled and innovation is not rewarded. Young energetic people with good ideas have increasingly less opportunity to contribute to cancer research and are not attracted to the field.
In a similar vein, most of the federal research dollars available for clinical trials to test these new drugs are controlled by a few organizations, the national cooperative groups. Most of the clinical trials in this country are developed and conducted by these groups. The Cooperative Groups are run by a small group of academics who are more interested in their own career development than they are in advancing medical knowledge. Developing new clinical trials is overlain by academic politics and compromises, and takes an inordinately long time--often years--and tends to favor conservative unimaginative studies Young, innovative clinical investigators have little opportunity to participate and bring new concepts. Very little of these funds actually get to the clinics that treat patients, and even fewer to the small community hospital. What is worse, the few innovative trials testing new drugs are often available only in the academic, university hospital, further restricting access to the small community practices which care for most of the cancer patients in the US.
In summary, there is a shortage of new talent going in the field, inefficiency and waste in using research funds, and little opportunity for innovation. The research funding system in academics is broken, and cancer research will be stifled until it is fixed.
The problems with clinical research are even more extreme, and make it difficult to get new treatments evaluated by testing them on cancer patients. Although none of us would want to do away with FDA regulation or IRB review, these processes are time-consuming and expensive, and could be simplified so they benefit the patient as well as the investigator. There should be streamlined mechanisms to get drugs into clinical trials. The IRB structure, in particular, is wasteful and outmoded; initially set up to protect patient safety during trial design, IRBs often see their role as one of preventing trials from going forward; although central and national IRBs are starting to gain acceptance, most private hospitals still rely on their own internal boards, which are slow and often unreasonable. Add to that the fact that each institution sets up its own regulations that make it difficult and expensive to open a new cancer drug trial. Enrolling patients, chart abstraction and data collection are often prohibitively expensive, particularly for the small institution, who often opt to do without clinical research, thus depriving patients of the opportunity to access the newest treatments.
In this day and age of instant communications, it would make more sense for every physician to have access to any and all clinical trials on a national level rather than on an institutional level. New cancer treatment drugs should be available to everyone. A uniform electronic medical record (EMR) would greatly facilitate a model like this as it would enable most of the chart abstraction and data collection at low cost to the institution. Although there is a lot of resistance to a uniform national EMS, it is necessary if we want to maintain our strengths in cancer clinical research.
But the greatest barrier to clinical trials is the clinic itself. It takes time for a doctor to evaluate, consent, and enroll a patient on a clinical trial--even if that activity is delegated to another professional, it still takes dollars away from the practice, and some of the doctor's time. And the structure of today's clinical practice--as mandated by Medicare and Obamacare insurance dictates--provide no additional reimbursement for this activity. In fact, there are disincentives to enrolling patients on trials. Physicians should be allowed to bill an extra half hour of time (which is quite realistic) when caring for cancer patients who are enrolling or enrolled on a clinical trial.
It should be a national goal of our health care system for every cancer patient to be enrolled on at least one clinical trial, including tissue banks, registries, quality of life, as well as treatment trials. Achieving this goal will not only improve our cancer research, it will also improve the health of our nation.
Carol A Westbrook, MD, PhD, is a medical oncologist at the Henry Cancer Center in Wilkes-Barre, PA. She is a former cancer scientist, and author of the book, "Ask An Ocologist: Honest Answers to Your Cancer Questions."
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