Is excessive regulation to blame for stifling pharmaceutical research?

Sukree Sukplang/Reuters

Every day brings some new tale of horror; unsuspecting customers duped by a greedy pharma peddling a toxic drug or malfunctioning device. Headlines read: They Knew; Should Have Known; Could Have Prevented. Constant drumbeats reinforce the notion that, without Food & Drug Administration (FDA) oversight (and plenty of plaintiffs' lawyers), corpses would line the streets.

The FDA's mission is to protect the consumer. They are the white hats, the good guys who are perennially untroubled by imposing additional trials or larger patient population samples on manufacturers, or meticulous and lengthy decision making processes within universities and federal agencies. Why should they be? According to ex-FDA commissioner Alexander M. Schmidt: "In all of FDA's history, I am unable to find a single instance where a congressional committee investigated the failure of the FDA to approve a new drug. But, the times when hearings have been held to criticize our approval of new drugs have been so frequent that we aren't able to count them....The message to FDA staff could not be clearer."

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Imagine if we approached automotive safety in the same way that we approach drug and medical device safety. Would any new car model ever make it to the showroom? While each defensive regulatory decision is likely justified in and of itself, when you add them up, the costs begin to outweigh the benefits, or even common sense itself. In fact, the price of bringing a medicine to market, per billion spent, in constant dollars, has increased by a factor of 100 times over the last sixty years. This is Moore's Law in reverse.

Consequently, pharma has developed an ever greater fear of developing new medicines. The industry is fleeing its R&D roots and focusing more and more on mergers, and on flogging drugs and devices that have already been approved. By some estimates, current pharma sales and marketing budgets are already twice those of R&D.

This brings me to the topic of traffic jams.

There was a point, once upon a time, when cars on the Washington Beltway actually used to move, except in one place, which used to back up for miles every day at the same exact time. It drove traffic engineers nuts because there was no clear obstruction. Then someone finally realized that the jam was caused by a single citizen, one who commuted in the far left lane, driving exactly the speed limit for miles on end. After some furious volleys in the media, and plenty of curses along the roadway, the Washington Post received a letter that basically said: I'm John Nestor. I find it easier to drive on the left. I follow the speed limit. If anyone wants to speed that is their problem.

The outraged citizens of D.C. promptly coined a term for this type of excruciating law-abiding behavior: "Nestoring." All very funny, except that Mr. Nestor worked at the FDA, and was charged with making sure various compounds were safe. Not surprisingly, he did not find any drugs that satisfied this condition. After a few decades, Ralph Nader's Health Policy Group praised Mr. Nestor for "an unassailable record of protecting the public from harmful drugs," a standard one can apparently only meet if one never approves a single compound.

But if one assumes that even greedy and evil businessfolk also want to save lives, and that occasionally they come up with useful compounds, might there be a cost to excessive regulation and safety trials? If the cost and investment required to bring a new drug to market gets above a certain level, then no company will invest in a discovery. And if a desperate patient advocacy group, foundation, or government does not fund the research, then the discovery will quietly die. And so will many people.

What is the specific crossover point where more are killed or hurt by excessive costs and regulation? We do not know, but that elusive point is Medicine's Missing Measure.

We are constantly reminded of the costs of acting. They play out in courtrooms everywhere. But we do not explicitly measure the costs of not acting, of not bringing products to market, or of not acting quickly enough and taking an extra decade to bring something to a pharmacy. Increasingly, medicines and medical devices are approved in Europe before the U.S. Following European approvals, the U.S. demands additional trials, despite hundreds or thousands of patients already treated. How many Europeans are saved while U.S. patients wait for regulators?

Perhaps, for many new compounds, there may be substitutes or alternatives. But if they are inferior, or costlier, then the sick suffer. Sometimes these costs can be enormous. A seven year delay in Beta blockers may have killed over 100,000. Few companies dare take on tuberculosis or malaria, which kill millions, because the development costs are high and most patients poor.

Is it possible that if one added up the delays, deferrals, denials of funding, and spiked projects, one might find that the number of people killed each year by what we do NOT do exceeds those saved by regulation by one or two orders of magnitude? The problem is not just the FDA, but a collection of actors conditioned to block, question, delay, and defer, including institutional review boards, cautious researchers, skittish CEO's, cynical financiers, and fearful universities.

Perhaps the first step to address this problem would be to compel the government to establish a rapid, and continuously evolving, rough measure of what it costs to NOT act, simply to get a sense of orders of magnitude. If the combination of regulation, time, and cost roughly equals the total lives saved and/or disability life years prevented, then one can always improve the approval process, but change should be marginal, because in general the costs are justified. However, if a rough back of the envelope calculation shows there are millions dying or disabled and suffering because it takes too much and too long to approve drugs and devices, then the fix required is not marginal. In this case, one would want to see a brutal restructuring driven by measuring the cost of NOT acting, forcing each actor in this system to be acutely aware of the consequences of their actions, or lack thereof.