Road not taken: the unrecognized harm of excessive regulation

A variety of pain relief medicine on a store shelf, including Tylenol Extra Strength capsules.

Article Highlights

  • Both biopharma companies and patients await new treatments, finding themselves struggling for viable solutions

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  • A deliberate and very conscious regulatory policy is putting a damper on what used to be the most vibrant drug development ecosystem

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  • Regulators substitute their own extreme value judgments for the considered views of others who may thoughtfully come to a different decision

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The difficulty of creating new and better medicines has been the subject of extensive – at times excessive – soul searching, a process that’s intensified as high-profile patents expire, along with their associated revenue streams, traditionally relied upon to support future R&D.  As a result, both biopharma companies and patients awaiting new treatments find themselves struggling for viable solutions. 

"The result has been bad for the entire bio- pharmaceutical ecosystem, and most unfortunately of all, absolutely disastrous for patients."--David Shaywitz, M.D.

Predictably, industry (where I obviously reside) attributes excessive regulation, regulators say “don’t blame us,” and considered reporters and observers typically try to split the different – maybe everyone is a little bit at fault.

The problem with this resolution is that it’s a cop-out; while there is clearly a measure of shared responsibility, it’s willful blindness not to recognize the extent to which a deliberate and very conscious regulatory policy is putting a damper on what has traditionally been the world’s most vibrant drug development ecosystem. 

It’s not that other factors (such as the complexity of science) aren’t important – in fact, it’s precisely because developing new drugs is challenging, so inherently difficult, that’s it’s crucial to do everything within our control to work together and create an environment, an ecosystem, that stimulates and enables meaningful innovation.

The most significant – and potentially, most correctable (which is why it’s especially frustrating – it’s explicitly of our own making) problem – is that regulators, as others have astutely observed, seem to have misapplied the “precautionary principle,” colloquially understood as “first, do no harm.”  The problem isn’t so much the sentiment as the way it’s reduced to practice. 

We are far more attuned to the potential harms a new product may create than the potential harms a new product may avoid.  No regulator wants to face a Congressional committee – generally a bipartisan committee, incidentally, as indignant posturing and self-righteous outrage seems easily to cross party lines – demanding to know why an approved drug was ultimately discovered to cause unexpected problems.  Raise the bar for approval high enough and you reduce the likelihood of this occurring.

Unfortunately, far less attention is paid to the reverse – to the very real patients who never receive a new medication because excessive regulation resulted in prohibitively high hurdles, effectively dampening work, disincentiving investment, and stifling progress.

Perhaps this is the policy we want: regulators face an admittedly formidable challenge (essentially, predicting the future), and in some cases, as I’ve explicitly noted, have been way ahead of the curve – for example, in highlighting the very real need for more investment in assessment science. 

Yet, as regulators seek to weigh the potential benefits and risks of a new medicine, my own observation is that they tend to be both tentative and ultra-paternalistic; many seem to feel they must somehow protect doctors from themselves, and the result is that patients are systematically denied access to medicines that might be useful, and for whom the risk/reward, when fully understood and discussed with their physician, would be worth it. 

This is a critical point: not everyone has the same view of risk/reward, and by positioning themselves on the far, far end of this spectrum, regulators effectively substitute their often extreme value judgements for the considered views of others who might thoughtfully come to a different decision.

Truth is, regulators don’t trust patients and doctors to make these judgments, and take these decisions into their own hands; the result has been bad for the entire biopharmaceutical ecosystem, and most unfortunately of all, absolutely disastrous for patients — of course the very people who regulators are ostensibly trying to protect.  How wonderful it would be if the many patients who are denied access to the new medicines a healthy ecosystem might have created were to enjoy the same degree of advocacy, voice, and incessantly aired late-night TV advertisements as those who claim to represent patients allegedly harmed by approved products.

But don’t take my word: instead, listen to one of the most compelling talks of TEDMED2011, presented by Juan Enriquez, and available here.  Enriquez presents an accessible and sensible discussion of the problem of the uncaptured costs of failing to innovate; this short video should be required viewing for anyone who cares deeply about this space – and that should be all of us.

(PS Those interested in TEDMED2011 might also enjoy Eric Schadt’s talk, here; I’d also commend this high-level review of TEDMED2011, offered by Luminary Labs, here).

David Shaywitz, M.D., is an adjunct scholar at AEI

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