EDITORIAL

Can You Believe “Regulatory Science?”

W e received as a press release in an email today (August 19, 2010) with the title “DHHS Secretary Sebelius Declares Investment in FDA Regulatory Science to be a Critical Component of National Security.” Issued by the Alliance for a Stronger FDA, this missive praises HHS Secretary Kathleen Sebelius for her forthright advocacy for regulatory science at FDA. At a press conference held on the same day of the press release, “the Secretary highlighted regulatory science as part of a long-anticipated report reviewing the development and approval of Medical Countermeasures (MCM) that would protect Americans from a bioterrorism incident or a naturally occurring emerging infectious disease.” Curiously, the email did not contain the choice to opt out.

The Pope’s Army

Wouldn’t these activities be more appropriate to the Department of Defense or the Centers for Disease Control and Prevention? Or does Health and Human Services (along with the FDA) now wish to command military divisions? Joseph Stalin once sarcastically said, when asked about the proposal of bringing the Pope to participate in the Allies War Conferences, which were discussing the fate of post-war Europe, “The Pope! How many divisions has he got?”

Continuing with the press release: “We appreciate the Secretary’s recognition of the importance of FDA’s regulatory science initiative and her highlighting of FDA’s vital role in national security,” said Wayne Pines, President of the Alliance. “Strengthening regulatory science at FDA is a priority for Commissioner Hamburg and should be a national priority. This program needs to be well-funded so that the FDA can continue to develop and expand its scientific capacity.”

All Animals Are Equal

A broad definition of “science” is any systematic knowledge capable of yielding correct predictions or reliable outcomes and involving a highly skilled technique, technology, or practice, along with careful analysis of the data. There are physical sciences and social sciences, the former quite advanced, and the latter retarded by comparison. To blend the two together is to weaken one at the expense of the other, or to dilute the value of both.

Here’s the punch of the press release: “The review identified a need to upgrade science and regulatory capacity at the FDA. As a result, HHS will make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market.” So, in other words, the goal of “regulatory science” is to increase the power of public scientists to lord over private ones, and to dictate their conclusions in terms of “a clear regulatory pathway.” In another sense, as George Orwell wrote in Animal Farm, “All animals are equal, but some animals are more equal than others.”

Could there be any dissent from this “noble” goal? Not according to the press release: “All Americans agree that our national priority is to prevent and respond to bioterrorism and naturally occurring infectious diseases,” said Nancy Myers, Vice President of the Alliance. “FDA’s role is to support the development of MCM products and approve those that meet the standards FDA has set.” But this seems like a lot more than just support, doesn’t it? They are talking about commandeering “science” and increasing policing power in the name of the public safety and interest.

Playing with Fire

The Founding Fathers of the American republic warned about some of problems inherent in issues of defense, which can be thought of as playing with fire. For example, James Madison (the 4th President) said, “The accumulation of all powers, legislative, executive, and judiciary, in the same hands, whether of one, a few, or many, and whether hereditary, self-appointed, or elective, may justly be pronounced the very definition of tyranny.” HHS is in the executive branch of government. Declaring war is a function of the legislative branch. And deciding “regulatory” issues, or the application of law, is properly a function of the judiciary branch. So what we have at HHS and FDA is the usurpation of powers that the Founder’s warned against. Madison also said, “The means of defense against foreign danger historically have become the instruments of tyranny at home …” and “If Tyranny and Oppression come to this land, it will be in the guise of fighting a foreign enemy.”

Beware of Regulatory Geeks Bearing Gifts

According to the press release, “The Alliance for a Stronger FDA is a coalition of more than 180 consumer, patient, professional and research groups, companies, trade associations, and individuals who support increased appropriated funding for FDA. The Alliance is the only multi-stakeholder group that advocates for increasing resources at FDA to match the agency’s responsibilities.” Among the consumer groups are lots of public advocacy, not-for profit entities (most of which undoubtedly receive public funding), along with pharmaceutical companies, certain individuals (lawyers who represent patients and consumers, regulatory affairs officers, academics, etc.), trade associations (consumerist and advisory groups, for the most part), law firms and consultants (regulatory affairs), and former FDA Commissioners and former DHHS Secretaries.

You couldn’t find a more homogeneous group united by their support for a bigger role for government. You get the idea. Governmental geeks are on the march for an escalation of “scientific regulation.” In keeping with the concept of decelerating returns, this is the exact opposite of the Singularity, guaranteed to bring on the worst of the past.

Live long and prosper,

Will Block

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