Greed and Goodness
A registry would, of course, be a dramatic expansion of the FDA’s jurisdiction. Privacy advocates won’t be the only ones concerned about this. Bioethicists and academics argue that the FDA has its share of problems without adding on the job of managing a clinical-trials database and a citizens’ health registry. Conservatives and industry leaders will not be keen on the idea either, not least because it would be hugely expensive and put valuable information into the hands of government. As Hilts writes, the agency still finds itself trapped between competing constituencies: “Should the department err on the side of safety and the consumers? Or should it err on the side of business freedom until practices [are] proved to be dangerous?” Hilts concedes in his epilogue, “Greed and Goodness,” that despite pressure to do otherwise, the FDA should by now understand the risks that are inherent in the latter choice.
Hilts cites a series of experiments first hatched by J. Scott Armstrong, a management professor at the Wharton School at the University of Pennsylvania, that proved that if asked to play the role of a drug company executive, students put the interests of shareholders before the interests of patients taking the company’s medicines. “The experiment was repeated 91 times, in 10 countries, with 2,000 subjects and 23 different experimenters,” Hilts writes. “If the membership of the company’s board was not artificially altered to include outsiders and specific details about harm were not given, in North America and Europe, 76 percent of the board members took the most irresponsible course. None chose the most responsible course.”
Of course, there are conservative partisans in America who have long felt that it would be best to narrow rather than expand the FDA’s mandate. In 1996, in fact, House Republicans introduced legislation that would have obliterated that mandate. Fortunately, the bill got nowhere. Hilts says that history proves that the Right has never liked the FDA. But he makes note that the Right’s hatred and angst reached its apogee during the days of the Republican revolution. In the House of Representatives in 1996, “the Republican leadership was expected to drive the FDA ‘reform’ through in short order,” Hilts writes. “It was, as the conservative Republicans saw it, a battle of monetary and political force in the service of moral certainty.”
In a column in Reason, science correspondent Ronald Bailey sums up the Right’s mantra: “Being too cautious can kill you. And the FDA is the avatar of bureaucratic caution.” This fixation seems to endure even when tragic events like those involving Vioxx suggest that the FDA is often not cautious enough.
Bailey uses as an example the gene therapy tragedy that took but one life, that of Jesse Gelsinger in September 1999. The FDA shut down similar trials of gene therapy within weeks of the news and launched investigations to find out what had happened. Bailey charges that the FDA overreacted: “The FDA began hastily scrutinizing all gene-therapy trials with an eye to finding not just egregious violations, but even technical paperwork missteps. Spooked bureaucrats who want to stop something that they fear might get them in trouble tend to bury those they regulate in mounds of paper and interrogatories.”
Bailey rightly points out that whether the FDA misunderstands the risks and rewards of new medicines like gene therapy, or simply overreacted to one clinical trial’s tragic result, it is ill-equipped to handle the complexities of emerging technologies that don’t easily fit into standard FDA protocol. Medical therapies will only become more scientifically complex, so the FDA had better hire the staff and purchase the tools necessary to approve the new medicines and then monitor them carefully once they are on the market.