FDA Lacks Transparency in LASIK Investigation

Reprinted with permission from www.fdaweb.com
Oil Spill Has a Lesson for FDA: Federal Impotence

[Analysis by Jim Dickinson*] Some sides see it as that old Washington blame game — the Gulf of Mexico oil spill is “Obama’s Katrina.” That may be so, but nevertheless, there is a sobering message for FDA in this disaster.

If only it could be as small as Katrina! It may be an oily albatross around Obama’s neck that could outlast Katrina and the Bush era by decades and saddle the President with a legacy more humbling than Jimmy Carter’s: in a word, public ineffectuality.

It seems that almost everything Obama has attempted has been either over-reach or much less than it seems — in other words, ineffectual in the Carter sense. It is very hard, 30 years out, to remember what Carter’s presidency left us. Like other one-term presidents, perhaps it was just that he was a good-hearted, idealistic leader who left no lasting marks on government.

At FDA, this may be what the Obama administration also will leave us. To say this is not to demean the dedication of the true believers Obama sent to FDA, or their sincerity. Instead, it is to recognize what is so evident in the Gulf of Mexico: the ineffectuality of the federal government when crises erupt and defy distant, central control.

As it was in Bush’s time, so it also is in Obama’s: Central control, seemingly effective in other countries that have foreign histories, doesn’t work in the decentralized American culture. Our culture was uniquely born in defiance of central control; it will not easily be “Europeanized.”

U.S. Coast Guard Commander Thad Allen told the media 5/24 he would not recommend government takeover of the oil spill in the Gulf. His main reason was that the expertise to handle it lay beyond federal hands.

Similarly, in combating the illegal immigration invasion of our border with Mexico, and its ruthless and parallel bloody drug war, the federal government has shrunk so much from the challenge that 17 states are reportedly following Arizona’s example in trying to intrude on a federal responsibility.

So it may be with FDA’s inability to discharge the unprecedented burdens placed on it, as a central authority in charge of how health products enter the U.S. market, and in charge of what is said about them and their effects. For many years as an economy measure the agency has been outsourcing much of the scientific and technical expertise on which its decision-making may rely. Does this unavoidably lessen its control over the factors impacting regulatory decisions?

One-fourth of the U.S. economy is regulated by FDA, yet the agency seems increasingly unable to prevent catastrophic accidents like tainted heparin from China, food and drug contamination from multiple other sources, data fraud in clinical trials and reckless/negligent manufacturing practices both at home and abroad.

As such incapacities provoke public criticism, FDA has answered by applying central control over the news media, lest lack of confidence in its mission be spread. As just one example, our questions since mid-March to find out who is conducting the joint FDA-Department of Defense study of LASIK post-surgical outcomes and the study’s protocol have been routinely deflected by the FDA Press Office, the sole entry-point into the agency for the news media.

Why? Nobody, not even principal deputy commissioner Joshua Sharfstein, who heads the agency’s much-promoted Transparency Task Force, will answer. The hypothesis this presents is: Was the FDA-DoD LASIK outcomes study given to pro-LASIK Navy surgeons to achieve a biased result that would (a) vindicate CDRH’s 1997 approval of the LASIK indication despite the chief approver’s public recanting of that decision since, and (b) rescue an entire industry from liability lawsuits?

Other examples of FDA ineffectuality have been long documented on this Web site, including the agency’s failure to master the regulatory science on mercury evident in last year’s dental amalgam rule, the disarray in the 510(k) program, the agency’s dependency on industry in the BPA controversy, its humiliation in the Plan B fiasco, and numerous others — all the result of apparent inner weakness in the face of outside, publicly unaccountable special interests. To this list could be added the less-visible sheltering of agency officials from public accountability, a byproduct of undocumented restrictive media access policies since the preceding Administration erected unconstitutional barriers that many vulnerable managers welcomed.

If this sounds a little like the oversight that the U.S. Minerals Management Service was supposed to exercise over BP in the Gulf of Mexico but didn’t, it is meant to. “Over time,” writes Atlanta Journal-Constitution blogger Jay Bookman, “MMS became captive to the industries it was supposed to regulate, serving as an advocate for industry interests and an apologist for its excesses and repeatedly siding with the industry over the taxpayer on financial issues.” A 5/25 posting on MMS’ parent Department of the Interior Web site discloses management and staff misconduct reminiscent of FDA’s own generic drug scandal 20 years ago, only more blatant and imbedded.

Does daylight-shielded MMS sound a teensy bit like daylight-shielded FDA? Or like most other daylight-shielded federal departments and agencies whose performance under stress repeatedly leaves the U.S. public disillusioned with Washington? Does their stovepiped work environment in bureaucratic silos prevent them from seeing and learning from other agencies’ seemingly dissimilar issues?

Could FDA be held hostage like MMS to private-sector expertise on regulated health products that is held only in a regulated company, and an ineffectively regulated one at that, like BP?

Sent a pre-publication draft of this report, principal deputy commissioner Sharfstein delegated it to an unnamed subordinate who did not respond before deadline.

* Jim Dickinson is FDA Webview’s editor.