17 Jan Overtreated and Underinformed: Too Much Medicine, Not Enough Evidence
Overtreated (ō’vər trēt ĭd) n.
- The act, manner, or method of handling or dealing with someone or something.
- Administration or application of remedies to a patient or for a disease or injury; medicinal or surgical management; therapy
- The substance or remedy so applied.
Over the holidays, I was able to read a raft of some of the latest health care pundit books. Having just finished Dr. Groopman’s book, “How Doctors Think” (commentary forthcoming), I am halfway through Shannon Brownlee’s “Overtreated”. I just got though reading a brutal chapter entitled “The Desperate Cure”. Brownlee carefully recounts, in story like fashion, the incredible rise and fall Bone Marrow Transplantation therapy for breast cancer. Once hailed as the breast cancer “cure”, she reviews the initial scientific breakthroughs, the preliminary clinical experience with the therapy, its growing popularity spurred by enthusiastic physicians who absolutely believed in its curative benefits, and the lawsuits which ultimately forced insurers to pay for the unproven therapy. Continuing on she recounts the growing uneasiness of proponents as unconvincing data began to return, and then the spectacular flameout once the randomized, controlled trial was finally published. Within months, plush cancer treatment centers would be deprived of a prized revenue stream.
The finally tally: $3.4 billion dollars; 42,000 transplants; 9,000 treatment induced deaths; and no difference in outcomes over standard breast cancer treatment.
I was left with the disquieting feeling of being angry at the events, but without a clear person to be angry with:
o It was understandable how the physicians promoting this therapy, who were making difficult medical decisions based on the best evidence they had, might have been overly swayed with the early clinical successes and the potential pantheonic possibilities of creating a true cure for inevitable death of breast cancer. When did they know the treatment wasn’t a cure, and did the new financial paradigms they had created with highly lucrative transplant centers delay their response to the data?
o It was understandable how the desperate patients, many of them mothers of young families, would be willing to subject themselves to the horrors of transplant protocol even if there was only a sliver of hope for “cure”. What risk is worth the reward for a few more years? What care was not provided because precious resources were diverted to this exceptional expensive experiment ($100K-$500K)?
o It was understandable why payors would initially deny coverage for this “experimental” treatment; it was also understandable why they would cave to the public pressure as no one wants to fight the “bad insurance vs. soccer mom with potential cure” argument. When does a treatment pass from experimental to proven – what is required? In this case, court cases made the decision that the procedure was “proven enough” to force payment for it.
o It even understandable (I can’t believe I am saying this) why lawyers would be all over this denial cases particularly when sympathetic jurors were awarding $90M+ verdicts against the payors for denials of coverage. What lawyer wouldn’t want to litigate the David vs. Goliath case? Who couldn’t win that case in front of a jury – particularly when you have multiple scientific papers showing efficacy.
So who or where should I direct my anger? What am I angry about?
Perhaps, the way that Brownlee presents this makes me upset. Physicians are born, bred, and trained to help cure disease and illness. They want to be on the cutting edge of providing the very best care, using the latest evidence, and provide the best outcomes. However, a lot of what we do in medicine does not have enough supporting evidence one way or the other. In the face of such hard core evidence, I believe most physicians are ethical enough to change their practice. Without this evidence, however, the only thing you can do is provide the standard of care, or the medically/culturally accepted mode of therapy, or “best practice”. I am not sure why Brownlee is so surprised that medicine is partially about experimentation, iteration, and refinement. How else would we know some of the things we need to know without trying some of the things that were tried in the Bone Marrow Transplant example above?
Furthermore, all of the women voluntarily signed up for the procedure, they were explained the risk and benefits based on the latest evidence, and they were even given the opportunity to participate in trials that would definitively answer the questions ultimately answered in 1999. As long as this was done transparently, with appropriate medical consent, with appropriate explanation, the patients made a conscious decision to move forward with the treatment. The evidence, at the time, was enough of a ray of hope for them to endure the storm clouds of the therapy. The patient should have the right to make this decision.
Where it starts to get gnarly, however, is how and by whom these experiments are paid for. Turns out, that the collective pool of patients in commercial insurers footed this bill (Medicare always considered it experimental). To be candid, I don’t think this is an unreasonable source to fund the science, the treatment innovations, and the outcomes studies required to know how to delivery the best care. As an insured individual, I am actually OK paying a portion of my premium for therapies that are “unproven” so that they can get “proven” one way or another. And, as noted within the example, as soon as it was proven with data, we can and should then adjust the practice of medicine and the payment for health care services. Apparently the Congressional Budget Office feels that same as they will take on a $2/head charge in 2011 to private carriers to conduct this exact type of “comparative effectiveness” research.
So the culprit in my opinion is the data; or more appropriately, the lack thereof.
Data remains one of the key elements so often missing within healthcare. While we are on the cutting edge in so many areas, we lag sorely on basic health care research to help answer these important questions. Health 2.0 is all about next generation health care wherein data drives discovery, best practices, higher quality, and improved outcomes at lower cost. It is in the aggregation, analysis, and sharing of information that we can improve how we practice medicine. Without the tools, technology, and funding to carry out this research, we will lack the informational evidence to delivery the best health value (outcomes/price).
Perhaps the main point of Brownlee’s book is to demystify the House of Medicine and expose it for the apprenticeship it actually is. Perhaps Overtreated is really a plea to eradicate chronically Underinformed patients, providers, and payors from the ills of too much medicine without enough evidence.