Ring in the New: The "Best" in Health Care

I want to ring in the New Year by wishing SHARE participants All the Best in 2011.  As I do so, I can't help wondering just what is the "best" that we are wishing for?  For sure, it is individual good health.  May each and all enjoy the best health possible.

But there is a more general Best, a societal Best, that I also wish for.  I wish that everyone diagnosed with breast or ovarian cancer may receive a standard of care that takes into account both impact on the cancer, and impact on the whole person.  For that wish to come true, "best" must mean a treatment or treatments tailored for a particular individual having a particular form of disease in the particular order and dosage best suited to her and having the least likelihood of causing harm.  Most important, best means having no chance at all of causing more harm than good.  

Unfortunately in recent years we have seen treatments used that don't meet this standard. We have witnessed, in fact, a mad dash for more treatments, more choices, with too little attention paid to either long-lasting effectiveness or long-lasting safety.  We have seen drug companies piggyback a new drug on an old one and claim superior results, then charge huge prices for the new drug when the real benefit of treatment continues to come from the old one.  (See December's blog by Ilene Winkler on Avastin, which was added to an effective taxane long in use).  If doctors accept these drugs as new and better, without knowing all the consequences, they can become the gold standard of care, even in the absence of broad-based, systematic information about outcomes, including side effects.  (See my blog in November about clinical practice guidelines).

So "Getting to Best" is what I wish for in 2011.  Getting to Best calls for some major changes in drug regulation and in clinical practice.  

One place advocates can help target better choices is at the Federal Food and Drug Administration (FDA), which must approve all new drugs or agents or new indications for existing ones.  That agency now agrees with advocates that Avastin causes breast cancer patients more harm than good.  Although this decision is a big win, too many people suffered serious harm while Avastin was widely in use under accelerated approval.  So one task for activists in 2011 is to help tighten criteria for approving treatments, especially if a drug company seeks accelerated approval.  Perhaps extraordinary positive results should be required in order to gain accelerated approval.  And perhaps a simple majority vote of FDA and ODAC (its advisory council, where SHARE advocates participate) is not enough; maybe a supermajority should be required.   Maybe fewer drugs will get approved, but better choices may actually mean fewer choices.  

Ideally, too, drugs targeted for accelerated approval at FDA should have relatively minor adverse side effects.  Unfortunately adverse effects don't necessarily show themselves within the time frame of accelerated approval.  Perhaps tightened tracking of outcomes, via required physician's reports and/or patient reports, could be imposed when an agent is in use under accelerated approval.  

Uncovering adverse effects as soon as possible meshes with another target for 2011: Comparative Effectiveness Research (CER).  CER identifies best clinical outcomes when there are different available treatments for the same condition.  (See my September 2010 blog post).  CER measures benefits and harms to arrive at Best Practices.

Gathering information about harmful outcomes is far easier said than done, of course. Sick people may not want to be bothered with reporting what's happening to them.  If they report to their doctors, all reports must be in one standard format to be useful for research.  Right now no one standard format is in use.   Doctors may feel they don't have time to manage such reports on patient condition and side effects.  Patients may feel that research results won't come in time to help them personally so attach little importance to reports.  

Here it seems is an important new opportunity for SHARE participants to play a role in improving treatments for breast or ovarian cancer.  When she reports her experience, a patient takes on the powerful role of doer, escaping the passive "done-to" role. If she can be sure that her information is pooled with that of other patients and analyzed by experts to yield conclusions about best treatments, she can know she is making a contribution to Best Practices.  True, analysis may not come in time to help any one individual immediately.  But it may help that individual in the future, and it will certainly help other people in the future.  

Support organizations like SHARE could possibly help improve recording of outcomes. For starters, it would be interesting to know from readers of this column who are in treatment with a surgeon, a radiologist, or an oncologist whether that physician records information about their current health status.  Status would include a wide range of conditions besides effect on the cancer itself: nausea, diarrhea, dizziness, indigestion, headache, burns, swellings, heart palpitations--and more.  Information about these conditions combined with data about a cancer's progression or regression, creates comprehensive patient outcomes.  

It would be interesting to know: Does the doctor ask specific questions?  Does the doctor write down the answers?  Does the doctor ask the same questions at each visit?  If the doctor doesn't ask, do you, the patient, offer information about specifics of your well being?  Does the doctor write that down?  Do you, the patient, sign off on the report? 

You can post your answers in the comment section below.  

Everyone in treatment for breast or ovarian cancer can help this new effort to create broad-based, best-case and worst-case information banks for patient outcomes. Everyone who sees any cancer doctor can ring in a New Year for Best Practices.