Culture Clash: Evidence-Based Medicine When We Need Miracles Fast

---

March 14, 2007 - 3:45 pm email to a friend printer friendly view / write comments

(0 votes, average: 0 out of 5)
You need to be a registered member to rate this post.

 Loading ...

Dr. West

Last year, one of the issues I was struck by in reading the comments on a few patient-oriented websites when I really began in earnest to participate in the online sites was the tension that can occur all too often between patients and oncologists. There are certainly many potential pitfalls, but one of the common themes is that many patients need a breakthrough fast and don’t need to see the results published in the New England Journal of Medicine from multiple large trials to be convinced that a promising approach is worth trying, while oncologists are often more conservative about providing access to commercially available drugs that aren’t indicated for a certain patient’s cancer. Whether it’s celebrex or sutent or DCA, these approaches represent legitimate hope when clinical and lab investigators describe the potential value of these treatments for improving survival. Often these conclusions are based on early data, from the lab or in some small clinical studies, and the media may provide a sound bite of brief analysis in which a brief story alludes to the next great breakthrough.

In fact, some of these treatments will, in fact, become valuable treatments, and a few will become miracles, or close to that. People with an unusual called a gastrointestinal stromal tumor (GIST) used to have very minimal therapy options, but with the new targeted therapy of Gleevec, they can have remarkably dramatic and long-lasting results. Tarceva, Avastin, and some newer chemo agents and targeted therapies may provide very gratifying benefits for many lung cancer patients. But there is often a cultural difference in the willingness of patients and oncologists to pursue a non-standard treatment.

While some patients are wary of being a “guinea pig” in clinical trials, plenty of patients with cancer are more than eager to try something new that has the hope of improving the expected results with standard options. I can definitely understand why a patient with advanced lung cancer, SCLC or NSCLC, or a previously treated mesothelioma (cancer of the pleural lining around the lung, another very challening but much less common cancer), would be willing to trade the statistics associated with our standard approaches for the unknown. Some of our treatments have modest enough benefit that it may seem very desirable to trade that for something new. Meanwhile, medicine has shifted toward becoming more evidence-based, and oncology is among the most data-driven of specialties. There are many great things about evidence-based medicine: it strives to truly define the best treatments and subjects approaches to careful testing, and it is fairly efficient about not pursuing questionably valuable strategies. That’s great for society as a whole, and it’s fine if you have effective standard options to pursue. It’s another matter for patients with advanced cancer.

From the oncologist’s perspective, many of us have been trained and really indoctrinated in an evidence-based model through medical school, residency, and our fellowship speciality training. But in reflecting on why there is such a focus on evidence, I think part of the reason may be more mundane, including financial and legal concerns. Now, more than ever, oncology treatments are often very expensive medicines that an oncology practice must essentially administer under the presumption that they will be reimbursed by the insurance company or Medicare. Treatment often is covered and reimbursed, and it’s remarkably more likely if there is good evidence to support this treatment. However, with some of these treatments now topping $10,000 per month, an oncology practice can find itself taking a very expensive hit if an insurance company decides not to reimburse a physician for Avastin given outside of the rather narrow FDA indication. Many practices express concern about becoming financially insolvent if this happens a few times. At the same time, there is the very real risk of being sued for a bad outcome, which unfortunately can happen very frequently in cancer. Chemo and molecular therapies have some pretty significant and even potentially deadly side effects (they’re fighting cancer, after all, so they need to be pretty powerful), and when bad things happen during treatment that was completely by the book, it’s tragic. But if there is a fatal complication from a treatment that was pushing the envelope and outside of standard practice, there is an all-too-real risk that someone will take the bait and call the lawyer advertising on TV about how someone needs to pay when something bad happens. We know that with a treatment like Avastin, there is a small but real risk of fatal bleeding, even if treatment is just as recommended. However, if you give that same treatment to someone who wouldn’t be considered eligible because of brain metastases or a squamous cancer or previously coughing up blood and they then have a fatal complication, you are now in the middle of a minefield, easy pickings for the lawyer who puts you in front of the jury and asks why you gave this treatment to someone for whom the drug is specifically not indicated due to safety concerns. It’s one of the significant reasons why many oncologists, like other physicians, can become quite risk-averse.

While nobody wants to let careful judgement be cast aside due to financial and legal concerns, the reality is that many oncology offices are struggling to stay afloat and can’t afford to treat patients next year if they don’t get reimbursed for $100,000 worth of expensive treatments this year. And the fact is the most physicians will be sued, some justifiably, but many because they are the physician of record when something truly awful happens, and there are people looking to profit from that misfortune.

I don’t mean to sound jaded, because I’m not. But as we struggle to come together in the lung cancer community, or the cancer world in general, it would be great if there aren’t separate sides for doctors and patients, but rather that we can all appreciate another perspective. I’ve been in oncology for several years but have learned a great deal recently about what patients and families experience from reading and participating in the patient-oriented online resources. It disappoints me to sense the friction of different camps, when we really have most of our goals in common. This is one place where I’m glad docs and patients and families can come together, even if just a cyber experience.

Posted in: General                     email to a friend printer friendly