OBSCURE OBAMA MINIONS SET TO THWART ADVANCE OF DRUG RESEARCH…

http://www.washingtontimes.com/news/2010/jan/19/crushing-drug-research-momentum/
MILLER: Crushing drug research momentum

Obscure new Obama minions set to thwart advance of medicinesMILLER: Crushing drug By Dr. Henry I. Miller

The inability of government bureaucrats to “connect the dots” and the resulting near-catastrophe when a Nigerian terrorist tried to blow up a Northwest Airlines flight from Amsterdam to Detroit on Christmas Day are a microcosm of pervasive shortcomings of the Obama administration. The failure to prevent an attack on an airplane, train or building has obvious and immediate consequences, but when the failures are incompetent or flawed policy – and decision-making at the vast alphabet soup of federal agencies – the impacts may be both obscure and significant.

Most important federal government business is conducted by senior officials at the myriad departments and agencies who perform essential day-to-day policy- and decision-making. Few of these officials’ appointments require congressional confirmation or receive much public or media attention, but they are critical because personnel choices ultimately are policy choices. The appointments are particularly important at “gatekeeper” government agencies such as the Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and Department of Agriculture (USDA) that are required to approve products such as pharmaceuticals, pesticides and other chemicals before they can be marketed. These agencies are becoming increasingly unscientific, risk-averse, politicized and easily prodded to excesses by congressional demagoguery. Their shortcomings may be less obvious and elicit less outrage than an airplane blown up in midair, but the effects can be far more devastating.

One example is the inestimable damage that has been inflicted upon the industries that develop new pharmaceuticals – medical devices (such as pacemakers and artificial joints), vaccines and human and veterinary drugs – which used to be among the nation’s most innovative and successful. But excessive, erratic and highly risk-averse regulation has pushed development costs into the stratosphere, made approvals uncertain and slowed them to a trickle. As Fred Hassan, chief executive of the drug company Schering-Plough said of the current regulatory climate, “What will it take to get new drugs approved? The point is, we don’t know.” Dr. Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, described the obstructionist culture at the FDA as having caused it to become viewed as “an agency that is supposed to keep unsafe drugs off the market, not to speed access to lifesaving drugs.”

The vast majority of FDA employees are civil servants; unlike some other federal agencies, FDA has only a handful of political appointees, but most of President Obama’s choices for them have been radical and inappropriate:

c Joshua Sharfstein, deputy FDA commissioner, who will, in effect, direct all day-to-day operations of the agency, has a history of anti-drug-industry bias that dates from his days in medical school.

c Ralph S. Tyler is a newly appointed general counsel whose main qualification seems to be that he is a crony of Mr. Sharfstein’s. This is a position that demands an independent, smart lawyer who is highly knowledgeable about food-and-drug law, but Mr. Tyler’s last job was as insurance commissioner of Maryland. He lacks any experience with FDA-related legal issues, and he surely will be in the pocket of his buddy Mr. Sharfstein.

c Peter Lurie, senior policy adviser, who previously was at the rabidly anti-drug, anti-industry, self-styled public-interest group Public Citizen. The appointment of someone with similarly strong pro-industry views would be widely condemned.

c Lynn Goldman, science adviser. This is a risible choice because while she was a senior EPA official in the Clinton administration, Ms. Goldman never met a regulation she didn’t like and oversaw extremely radical, unscientific policy- and decision-making, especially toward chemicals and biotechnology. She grossly misrepresented agency biotechnology policy in published statements. Her appointment is another illustration of the inside-the-Beltway adage that no bad deed goes unrewarded.

Many other Obama appointees who will be in a position to influence science- and technology-related issues are ideological, radical and poorly qualified to offer sound, unbiased advice on policy. They have a record of hostility to modern technology and the industries that use it: Kathleen Merrigan, the deputy secretary of agriculture; Lisa Jackson, EPA administrator; Steve Owens, who heads the critical EPA division that regulates pesticides and other chemicals; and Carol M. Browner, coordinator of environmental policy throughout the executive branch. None of them has shown any understanding of or appreciation of science.

Mrs. Browner was responsible for gratuitous EPA regulations that have slowed the application of biotechnology to agriculture and environmental problems for more than a decade; Ms. Jackson worked in the EPA’s notorious Superfund program for many years; and Ms. Merrigan relentlessly promoted the organic food industry in spite of the facts that the high costs of organic foods make them unaffordable for many Americans, thereby discouraging the consumption of fresh fruits and vegetables, and that because of their low yields, they are wasteful of fuel, farmland and water. Mr. Owens, a lawyer and global-warming zealot lacking any scientific expertise, was criticized widely as a fanatic and job-killer when he headed the Arizona Department of Environmental Quality. Finally, perhaps because of her passion for organic methods, while a staffer for the Senate Agriculture Committee, Ms. Merrigan was completely uneducable about the importance of genetically improved plant varieties to agriculture.

Mr. Obama’s choices for pivotal positions are a time bomb more devastating than that wielded by any terrorist. Throughout the government – policy by policy, decision by decision – his minions will damage the nation’s competitiveness, ability to innovate and capacity to create wealth. They exemplify what Newsweek and Washington Post contributing editor Robert Samuelson has called a “parody of leadership.” Perhaps, like the Christmas Day terrorist, these appointees will succeed only in setting their own pants on fire – but that’s not the kind of change we were promised.

Dr. Henry I. Miller, a physician and fellow at Stanford University’s Hoover Institution, was an official at the Food and Drug Administration from 1979 to 1995.

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