Jeremy Bentham for FDA Commissioner?

Remember Utilitarianism?  It’s the philosophy based on the principle of utility -- that the moral worth of an action is solely determined by its contribution to overall utility. And the poster boy of the Utilitarian School is Jeremy Bentham.  According to Bentham, “It is the greatest good to the greatest number of people which is the measure of right and wrong.”

If this sounds distressingly familiar it should.  It’s the philosophical foundation that underpins both NICE (the National Institute for health and Clinical Excellence) and HTA (healthcare technology assessment).

These philosophical musings are the result of a new and important article by Robert Jones (a retired Glaxo Wellcome executive and former member of EFPIA's economic policy committee from 1994 to 2006, and its chairman from 1994 to 2001).

A few points courtesy of Mr. Jones:

“Over the past 20 years or so, stakeholders in the medicines purchasing process have been grappling with the difficult problem of identifying value in prescription medicines. In the early 2000s there emerged a consensus that the way forward was through objective, methodical assessment of value by a cluster of techniques generically called "health technology assessment" (HTA); and this has apparently become the mechanism of choice as a procedure by which new medicines can establish prices and enter markets – a choice not only of purchasers but also of the suppliers, the pharmaceutical industry, which has expressed support for the ideas behind HTA for something over 20 years. Yet in taking this position the industry has perhaps paid insufficient attention to two vital strategic possibilities:

i. that systematised value assessment would not simply serve the interests of a free-market competitive contest but might tend to be captured by regulatory agencies which have predominantly purchaser-side responsibilities; and
ii. that the need to satisfy pre-established criteria of value could in due course have profound effects on the dynamics of a private-industry innovation system.”

And:

“Efficient public purchasing is a desirable goal. But as HTA processes in many countries – including the UK – often arrive at a point awfully close to rationing, it is the status of rationing as a means of delivering purchasing efficiency which needs examination. The role of NICE in the UK is instructive here.”

And relative to our friend Jeremy Bentham:

“The more serious point from which NICE suffers is an external failure to comprehend the utilitarian logic on which it operates (a failure of comprehension which NICE seemingly has little idea how to correct). NICE is often held to be an example to the world of enlightened drug policy administration. In fact, it is a peculiarly British institution, operationally tuned to British public policy objectives, and its procedures would be of uncertain temper if applied in other jurisdictions.”

“At the root of its operations is a Benthamite approach to health benefits. For NICE, value equates to social utility, the optimisation of which informs all of its judgements. Some of NICE's decisions may seem cruel in human terms, and ill-advised in public relations terms, but there is an arid logic to them which can usually be seen at work.”

“NICE's decision to withhold approval of donepezil from patients with mild Alzheimer's disease, on the grounds that an insufficiently high percentage of patients would benefit, while the drug was approved for patients who had progressed beyond the mild stage, was widely ridiculed. Why, it was asked, do we not allow the drug to do some good when patients are still enjoying some quality of life, rather than restricting it to use when a poor and declining quality of life can be only marginally reversed?”

To view Mr. Jones' full commentary, click here.

Utilitarianism isn’t a one-dimensional worldview.  Consider Bentham’s comment that,

“It is vain to talk of the interest of the community, without understanding what is the interest of the individual.”

If there’s a better statement of support for 21^st century HTA based on patient-centric rather than cost-based tools, I like to hear it.