Crowd-sourcing medical decisions?

Mar. 14, 2014 @ 06:57 AM

The heartstring-tugging case of Josh Hardy, the young boy who at first was denied a potentially life-saving but experimental drug but now will receive it, brought into sharp relief ethical dilemmas which medical and pharmaceutical technology can present.

The story of  7-year-old Josh and the small Durham drug-development company Chimerix went viral in social and mainstream media this week. Chimerix, which is moving toward key trials for a promising drug called brincidofovir, had turned down the family’s request for the drug under a program called “compassionate use.” The Federal Drug Administration will allow a patient to be given an untested and unapproved drug if all treatment options have been exhausted and the drug company will pay.

The furious onslaught Josh’s family and supporters unleashed eventually led to what one commentator called a “thread-the-needle” solution. The company sought and obtained FDA approval for a small pilot study -- and announced Josh would be the first participant.

For Josh, we are glad. We fervently hope this will bring the cure that has eluded him and his anguished family.

But the process leaves us pained. This is no way to make health-care decisions.

No one can fault Josh’s family. Who among us would not mount the most intense effort we possibly could to save our child? 

But is this any way to allocate scarce resources for medical care?

As Congress drafted and debated what eventually became Obamacare, the bill’s opponents shamelessly conjured the specter of “rationing” health care. Did we want federal bureaucrats deciding if grandma got by-pass surgery?

It was a red herring. Medical care sadly is rationed, by cost, by availability – by the generosity or the absence of insurance for a given patient.

Do we want it rationed by crowdsourcing? The animosity against Chimerix was so great its chief executive, Ken Moch, received death threats – an inexcusable reaction.

Moch summed up the dilemma faced not just by his company but by any drug researcher faced with a similar request.

“You can’t ethically say ‘yes’ to one and ‘no’ to another,” he told The Herald-Sun’s Laura Oleniacz Wednesday, the day after the pilot-trial solution was announced.

“We could not see a way, sadly, and I’m vilified for this, to make this available for just Josh Hardy,” Moch said. “If we could figure out a way to make this available for the many Joshes, we would, and we did.”

“The fact that this flood of public sentiment pushed this to happen shows that we are now firmly in the age of patient appeals through old and social media,” ethicist Arthur Caplan told Matthew Herper of Forbes magazine.

Herper continued, quoting and paraphrasing Caplan:

‘Save Josh, but what about the rest?’ A 67-year-old would still be out of luck, and that’s not necessarily a fair way to make experimental medicines that may not even work available.”

The choices in this case are excruciatingly difficult. That is all the more reason we need to think long and hard about the best way to make them. One thing is certain: We haven’t found it yet.