The President's Cancer Panel

The President's Cancer Panel

George W. Sledge, MD, FASCO

Sep 23, 2010

Yesterday I had the opportunity to testify on ASCO's behalf at the President's Cancer Panel. The panel reports to the President on the National Cancer Program and holds public meetings on a quarterly basis to gather testimony. The meeting I spoke at was entitled "The Future of Cancer Research: Accelerating Scientific Innovation." My session was populated by representatives of the federal government, with speakers from the FDA, the NCI, CMMS (Medicare and Medicaid), HRSA (the Health Resources and Services Administration), the EPA, the VA, and the CDC (the alphabet soup of  public health agencies). As the only non-governmental official speaking in this session, I had the opportunity to provide the perspective of what one of the speakers called "the private sector" (apparently governmentese for "citizen"). We each gave talks, followed by a moderated discussion. (My postion paper on the clinical trials infrastructure is available online at ).

What interested me about the talks was how little they were about science, and how much about process. Government is mostly about process, of course, but the deeper issue recognized by all the panelists was the degree to which progress in our battle against cancer depends on process issues: the infrastructure supporting modern cancer research, health information technology, and the approval of and access to new therapeutic agents. In the talks, and in the discussion that followed, one heard over and over again the frustrations of our public health officers regarding the silo mentality that restricts progress to our shared goal of reducing cancer's toll. Despite the alphabet soup of agencies residing primarily within the same federal department (HHS), there is relatively little communication or joint planning on major cancer issues. The barriers are in part due to lack of communication, but in some cases are built into federal statutes and regulations. The inability of the FDA and the NCI to agree on acceptable trial endpoints, or the inability of the FDA to give Medicare a head's-up on impending drug approvals, are two examples among many that I could cite where silos limit efficiency.

I would emphasize that the panelists are dedicated public servants. Several of them (Jim Doroshow for the NCI, Lisa Richardson for the CDC, Michael Kelley for the VA, and Richard Pazdur for the FDA) are long-term ASCO members and our colleagues. All function under structural limitations limiting their freedom of action. But all are genuinely committed to improving cancer care and breaking down the silos.  

These process issues are of real interest to our Society and its members, and our Government Relations group works tirelessly to forward our views on them as they arise. We believe that ASCO can play a useful role in informing and (in some cases) assisting government in its proper roles. For example, Dr. Kelley in his interesting presentation on the VA health care system (which has probably the most functional EHR system for a hospital system), mentioned that the VA used ASCO QOPI quality measures in evaluating cancer care. We are actively engaged in trying to support the development of health information technology in all its aspects--EHR, quality measures, electronic research records--and to ensure that these are interoperable, user-friendly, and (as far as possible) not burdensome. One of our society's visions of the future is that every cancer patient's experience will inform cancer research and (ultimately) effective therapy.


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Sep, 23 2010 6:06 PM

What about the "process" for lung cancer? I was 11 years old in 1971 when President Nixon declared War on Cancer. At that time lung cancer survival was 13%. Thirty five years later in 2006 I was 46 and diagnosed, as a never smoker, with stage iv nsclc (adenocarcinoma). The survival rate for lung cancer today is 15%. To me the statistics show that survival for lung cancer has actually decreased. Advances in imaging alone should have resulted in at least a 2% increase in survival. When is lung cancer going to be accorded the necessary attention and funding to reverse this deplorable situation?

I believe it is time to move forward with small molecule and monoclonal antibody therapies and make them available on a fast track, compassionate use, or accelerated and expanded clinical trials basis for stage iv patients. As a 4 year survivor pursuing aggressive and continuing therapy, I am in near perfect health but I cannot even qualify for a clinical trial because I am heavily pretreated and do not have measurable disease. Lung cancer patients have been ignored far too long. Please make it a priority to get them access to drugs that have the potential to extend their lives, their disease free progression. Rethink clinical trial design. Change endpoints. Have compassion.

George W. Sledge, MD, FASCO

Sep, 23 2010 7:32 PM

I hadn't meant to get into a discussion of the treatments for specific cancers, or how we get the new drugs to lung cancer patients in a timely fashion, but in response to Charmaine's poignant comments, here goes with my take on this area: 1) The prognosis of lung cancer plateaued in large part because the older chemotherapeutic agents, on which we spent decades of (relatively) unsuccessful work, failed to push the needle very far. I don't think we ignored lung cancer so much as nothing we tried worked very well; 2) In contrast to a number of diseases where we have been relatively more successful (CML, GIST, Breast Cancer) we did not have a very good handle on what drove the growth of NSCLC; 3) We are finally beginning to understand the biologic drivers of some of these cancers (EGFR and EML4-ALK, for instance), and fascinatingly the best results have often been in non-smokers such as Charmaine, probably because smokers have a different set of mutations.

Access to new drugs is always a tough issue. Until a drug is approved by the appropriate regulatory bodies (both in the US and abroad), pharmaceutical companies have little real incentive to produce large quantities of the drug, and as Charmaine rightly points out, even within clinical trials there tend to be significant limitations on who is eligible for a new agent. The latter issue may be changing somewhat: the recent crizotinib trial that enthralled us all at the June ASCO meeting allowed patients to have had several prior regimens, and indeed 41% of the NSCLC patients entered in the trial had received 3 or more prior regimens, something one may be able to do with a relatively safe and highly targeted drug.

We encourage all patients and physicians to participate in clinical trials, because we can imagine no other way to get to a cure for cancer than through such trials: we quite simply need information on efficacy and safety before we expose the general population of patients to drugs. At the same time, when a drug looks promising, it is certainly in everyone's best interest to get the drug to patients in a rapid fashion. One way of doing this prior to drug approval is through Expanded Access Programs, available for several drugs. In the past this option was cumbersome, little used, and poorly understood by practicing oncologists. The FDA has recently issued new guidelines regarding what are called "Individual Patient IND's" that make up the basis for expanded access, and working with the FDA we created a module for ASCO University that explains in a straightforward fashion what is required of a physician. This went online at our ASCO University website just recently ( ), and we hope it will allow patients like Charmaine to experience the benefits of active new agents.

We also, as Charmaine suggests, need to re-think clinical trial design in the era of biomarker-driven targeted therapy. I know that this is an active area of thought in the clinical research community, at the NCI, and at the FDA. In Charmaine's case, the lack of readily measurable disease sounds like a barrier to study entry as well. There are many barriers to trial entry, and like a growing number of clinical trialists I would prefer our trials to be more representative of the general population of cancer patients, with fewer exclusion criteria. At the same time, we still need to be rigorous in judging drugs; we have a responsibility to both current and future patients. Finding the right balance isn't easy, and certainly will require regular review.  My hope is that the problem of "unmeasurable disease" will ultimately have a technologic fix, in the form of improved imaging techniques and serum biomarkers that  improve both our ability to measure tumor volume and predict response.

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