In my column in the 11/25/04 issue, I indicated that I had been asked to serve on the American Society of Clinical Oncology Ethics Committee, and invited readers to comment on any problems, positions, or actions that the committee or ASCO should address.
I received a number of responses by e-mail and had oral conversations about others. The responses were varied and thoughtful. I will group them under several headings, though some of the responses overlap the categories.
Lack of Transparency
This was a recurring theme in most of the responses, which included a variety of examples that illustrate the concerns:
The academic physician pushes a particular regimen in a protocol while serving on the speakers' bureau of the pharmaceutical company (or receiving consulting fees) that has a financial stake in the outcome—Do patients know that he/she has a financial relationship with the company?
The academic oncologist receives research grants from industry for doing studies of its drugs or equipment—Do patients know of this payment?
The community oncologist has an ownership interest in a PET scanner to which he/she refers patients—Does the patient know this? Do the patients know that as a group, physicians with ownership in such facilities are more likely to order the test?
One reader was concerned that chairs of ASCO committees that make practice recommendations might be paid speakers of a company—for example, one that sells growth factors. Does the ASCO leadership know and condone this, and, if so, is this indicated in any written deliberations of the committee?
Pushing Regimens with No Significant Clinical Advantage
Some responders believe that academic “thought leaders” recommend new (and more expensive) regimens that offer little or no practical advantage; they attribute this to incentives such as academic advancement, research grants, and speaker or consulting fees.
Examples were offered such as “dose dense” regimens that require growth factors costing an additional $5,000 a month or more.
“Not surprisingly,” one reader wrote, “many of the authors“ smiling faces are on the numerous throwaway journalets that I get, unsolicited…there is a huge perception of 50-something academic oncologists' ‘cashing in’ on honoraria with these trials. ASCO is still dominated by full-time academic oncologists, and each year more of them are on this gravy train.”
Another respondent was concerned about the potential conflict of interest in Phase I studies: “Are the patients clearly aware of the small benefits, or are they simply told that ‘there is no guarantee that you will receive any benefit from this drug.’ When you think about it: if that patient enrolls, the person least likely to benefit is the patient and he/she endures all the toxicity (the institution, the physician, society, and the drug company all benefit).”
And another reader described a concern closer to home:
“Your patient is diagnosed with metastatic ovarian cancer. Standard therapy would be Taxol and carboplatin every three weeks. You and your staff are very familiar with the toxicity and efficacy of this regimen. You notice a new regimen of weekly Taxol and carbo in a Phase II study. Efficacy seems reasonable, and there might be some QOL advantages. At your last practice meeting your fellow physicians note that with questionable reimbursement for the coming years, we need to maximize chemo and nursing utilization to support all of the unpaid things we do like research and social and dietary help. You think: how can it hurt to give her weekly therapy? We get paid more so we can continue to be a good cancer center, the regimen will likely work reasonably well. Should the patient be aware of this thought process?”
Futile Chemotherapy & Poor End-of-Life Care
This is best described by one of the respondents who speaks for several other responders: “In the community I see major problems with end-of-life care of cancer patients, willful blindness to the obvious failure of curative interventions to make a meaningful difference. [I see a] failure of advanced care planning, truth telling, and goal-setting, all of which have ethical content.
“In my former academic role I observed that Phase I trials were presented dishonestly and proffered in lieu of appropriate end-of-life care (in order to avoid “difficult” conversations). As a result, a lot of dying patients are getting futile care in the ICU at the point of death. IRBs are great at looking at the scientific content of protocols but should be conjoined with an autonomous ethics IRB to assure dispassionate ethical review of clinical trials (matching risks and benefits).”
The Role of ASCO
Some respondents wondered how ASCO would fare in an independent analysis of its professional ethics, of its actual or apparent conflicts of interest. They believed ASCO should get its own house in order before telling others how to behave.
One reader recommended that the ASCO Ethics Committee have an independent ethicist(s) and/or independent community representatives as members; persons with no relationship to ASCO, its members or its benefactors.
This responder apparently believes someone from a patient advocacy group is part of the establishment because of financial support from or social integration in the oncology establishment and would not qualify.
Another suggestion is that the Journal of Clinical Oncology should encourage and publish more papers on professional ethics that deal with specific oncology issues.
Finally, one responder thought it was unethical for ASCO to put so little effort into public health oncology: He pointed out that reducing smoking has had far more benefit than many Gleevecs might, and hepatitis vaccine has been a far more powerful tool for dealing with liver cancer than all the surgery and chemotherapy.
My conclusions from this exercise are that, in general, oncologists are well aware of some potential and actual ethical violations and professional conflicts of interest. Most see the problem in others, and everyone I talked to was ready to offer an opinion or an example of unethical behavior by someone else, though it might be someone in their own practice group.
So I believe that this is somewhat like the proverbial turd in the punchbowl—everyone sees it there, but nobody at the party wants to do something about it.
Respondents believe that ASCO has an important role to play in professional ethics. I outlined my own ideas on this in the previous “ethics” column. Here is a summary of my thoughts from that prior column.
* First, as a professional association, ASCO can provide guidance for the highest ethical behavior in three ways: by its own example, by offering guidelines, and by education. ASCO has developed extensive guidelines for avoiding conflicts of interest for its officers and for commercial exhibitors at its meetings, but I know of no data on their effectiveness.
* ASCO could make its use of pharmaceutical company monies more transparent to the rank and file and to the public, perhaps providing an annual, detailed accounting in the Journal of Clinical Oncology.
* Second, ASCO can provide ethical guidance for the physician-patient relationship with special emphasis on areas prominent in oncology. For example, when is it appropriate to give second- or third- or fourth-line therapy that is of no known value for controlling the patient's cancer, and if so, under what conditions? Should it be never? Is it OK just because the patient or family wants to “try anything” or only in a clinical trial? Are fee-splitting and self-referral (e.g., to a facility or service in which the physician has a financial interest, usually unknown to the patient) ever acceptable?
* I am unaware that ASCO has a position on issues such as these.
* Third, ASCO can provide the oncologist with tools to blunt the unfortunate effects of the multi-billion dollar marketing blitz by the industry.
For example, how should one deal with patients who bring false hopes or request inappropriate therapy after seeing on television direct-to-patient advertising for prescription drugs? This would be an example of pointing the finger at ourselves, of taking responsibility.
My point, and strongly held belief, is that even if ASCO and its members had no actual conflicts of interest, it is right and prudent for both to recognize and avoid assiduously any potential and perceived conflicts, as well. This is one way to earn and deserve patients' trust, the bedrock of the physician-patient relationship.
I have spoken about these responses to the Chair of the ASCO Ethics Committee, Dr. Jim Armitage, and he said they would be discussed at the next meeting of the Committee, scheduled for early March.