Tuesday, June 28, 2016

Jail Time for Parents for letting Toddler Die from Meningitis

Last week a Canadian court sentenced David Stephan to four months in jail and his wife Collet to three months of house arrest for their role in the death of their 19 month old son Ezekiel in 2012.

When Ezekiel became ill, his parents thought he had some form of "flu," and treated him with herbs and a mixture of apple cider, vinegar, horse radish root, hot peppers, mashed onion, garlic and ginger root. A friend who was a nurse told them he might have meningitis, but they persevered in their efforts to treat him by the "natural" modalities they believed in. A witness testified that when they drove Ezekiel to a naturopathic clinic, he was too stiff to sit in his car seat. As his condition worsened, his parents had to feed him with an eye dropper. They only summoned medical help when Ezekiel stopped breathing. The child suffered severe brain damage from anoxia and died a few days later.

David and Collet are part of a community built around vaccine refusal and faith in "natural" remedies. David's father Anthony founded TrueHope, after his wife, who suffered from bipolar illness, committed suicide. The company markets EMPowerplus, a "natural" product that they claim as a cure for bipolar disorder, depression, and even autism. Ezekiel's father David is Vice-President of the company.

David and Collet were convicted under a Canadian law that requires parents "to provide necessaries of life for a child under the age of sixteen years." The prosecution asked the judge to sentence them to 3.5 - 4 years in prison, close to the maximum the law allows (5 years). The judge called that "too harsh." He required prison for David because David refused to take responsibility for his actions. He asserted that a government conspiracy to squelch vaccine refusal was at work, and blamed Ezekiel's death on faulty ambulance care. In the judge's view, Collet was less responsible for Ezekiel's death. In addition to house arrest, he required her to publish his findings on her website. After their jail and house arrest terms, David and Collet will be on probation for two years, and will be required to obtain regular medical attention for their children.

Adults capable of making decisions are and should be free to choose no treatment or quack interventions. But they should not be free to refuse potentially life saving interventions - like antibiotics for bacterial pneumonia - for their children. Seen through the lens of both law and ethics, the judge ruled correctly. David and Collet loved Ezekiel, but they - especially David - made decisions a "reasonable" parent would know to be wrong. Ezekiel paid for their commitment to their "naturopathic" doctrines with his life.

(For a compendium of articles on the situation, see here.)

Thursday, June 23, 2016

When is Rationing Ethically Accptable?

If I prefer a medicine that produces fewer side effects or marginally better outcomes, how much should you be expected to pay for my preference?

That's a question we in the US run away from. We'd rather say - "rationing is unethical! Period."

In truth, rationing happens all the time. The trend towards requiring us to pay a larger portion of our health care expenses out of pocket aims at making us responsible for our own rationing choices. If my physician recommends a CT scan "so we can be sure..." and I decide it's not worth the cost to me - that's self-imposed rationing. In our personal lives we make rationing decisions based on informal cost-effectiveness decisions every day.

But at the level of policy, acknowledging the need for ethically-grounded rationing is a third rail.

That's why the publication of Cost-Effectiveness of Long-Acting Injectable Paliperidone Palmitate Versus Haloperidol Decanoate in Maintenance Treatment of Schizophrenia is so important. for my field - psychiatry. In addition to providing valuable clinical information, the authors are admirably honest in presenting the rationale for potential rationing decisions.

Here's what the article is about:

Some patients with schizophrenia who benefit from antipsychotic medications follow their regimen reliably. But some don't, and for them a long-acting injectable antipsychotic medication can literally be a life-saver. I remember well a patient of mine who wouldn't take pills and wasn't keen on seeing a "shrink," but who accepted a monthly injection of haldol from his primary care physician. I made a serious joke with my colleague - "I may accomplish some useful things, but you are 'curing' schizophrenia in five minute appointments!" My patient and his family were enormously grateful that he functioned better and was happier than he'd been for a decade.

Paliperidone palmitate is still on patent and theoretically had some advantages over haldol decanoate, a much less costly generic medication. In a well-controlled randomized comparative effectiveness study, the authors compared the two medications, quantifying the differences between them in terms of quality adjusted life years (QALYs). Paliperidone had a slight advantage in terms of side effects, but at a cost of $500,000 per QALY, well-above what virtually every explicit discussion of QALYs has seen as an acceptable cost. Here's part of the author's conclusions:
The results of this study should encourage consideration of older, less expensive drugs, such as HD. Used at moderate dosages in this study, HD’s overall effectiveness and tolerability were only slightly worse...than those of PP, and it had clear advantages in cost-effectiveness...A rational policy for treatment of chronic schizophrenia might limit use of the more expensive [PP] to patients who do not benefit from or cannot tolerate HD. 
My colleague and friend Norman Daniels and I have written extensively about the overall ethics of rationing. I'm proud of the work we've done and believe it's useful. But progress in coming to grips with the need to ration care in a clinically grounded, ethically admirable manner will have to be done specialty by specialty in medicine, in concert with concerned members of the public.

The comparative effectiveness study of paliperidone and haldol illustrates four crucial steps that need to be taken for us as a nation to learn to set limits fairly:
  1. Develop clinically and humanly meaningful evidence about key treatment choices.
  2. Acknowledge the findings in an explicit, east to understand manner.
  3. Do economic analysis to define the costs involved with the choice.
  4. Decide whether the differences between the choices are worth the costs entailed.

The fifth and most difficult step is making use of these findings in the real world. In a health system based on competing health plans, health plan A would be reluctant to apply findings like these in its policies before health plan B does the same. If they did, word on the street would be "health plan A RATIONS CARE! How can we tolerate money grubbers like that in our health system?"

Learning to set limits fairly is more of a challenge to the heart than the head. At an intellectual level it's easy to see that limits are necessary. But thus far in the US, health system leaders, health care organizations, and the public have preferred to act as if rationing is evil and can be avoided.

That may have been true in the Garden of Eden. But, alas, that paradise vanished long ago.