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Last Updated

17 Jun 2003

Source: Washington Post, January 10, 2002.

Leadership Void Slows Top Health Agencies

By Ceci Connolly, Washington Post Staff Writer

Even as it copes with bioterrorism and an array of complex medical decisions, the Bush administration is running into trouble finding leaders for some of the nation's most critical health agencies.

The absence of leadership at the National Institutes of Health, the Food and Drug Administration and several other departments has raised concern that key decisions on vaccine development, cloning, prescription drugs, vitamins, stem cell research and the abortion pill mifepristone may be postponed or lack input from some of the best scientific minds in the country.

The void is so glaring that in recent weeks, lawmakers, industry executives, academics and patient advocates have aggressively lobbied the White House to put forth nominees. Meanwhile, Health and Human Services Secretary Tommy G. Thompson has turned to a cadre of outside consultants to help determine how to spend an extra $2.5 billion on bioterrorism.

"The bottom line is when the country is trying to mobilize for a huge new effort to fight bioterrorism, there aren't any generals for the battle," Sen. Ron Wyden (D-Ore.) said.

Unlike Cabinet secretaries such as Colin L. Powell, Donald H. Rumsfeld and Paul H. O'Neill, who have spent decades mastering the issues within their departments, Thompson has no medical or scientific background, making the need for expertise all the more acute, many in the field say. HHS lags far behind most other federal departments, with some top positions vacant for more than a year.

"Without good leaders, the agencies will continue to tread water without making any progress," said Mohammed Akhter, executive director of the American Public Health Association. It is embarrassing, he said, in a country with "the highest number of Nobel Prize winners in the world to not have people in these positions."

The vacancies appear to be the result of a combination of factors, including a delay in filling some jobs caused by the administration's struggle with the complex issue of funding for embryonic stem cell research and objections by Senate Democrats to candidates aligned with industry. But the delay also appears to illustrate how politicized many aspects of science and medicine have become, making it difficult to find stellar scientists willing to navigate the political land mines that come with top federal jobs.

Observers like Akhter also blame an element of "benign neglect" by the Republican administration.

"I just don't have the feeling it's been a first priority for this administration," said Paul Berg, a Nobel Laureate in chemistry and a researcher at Stanford University. "Most people are suspicious there's a litmus test to be passed. Certainly, the talk at NIH has been that somebody who is pro-choice, pro-stem cells and pro-cloning is persona non grata."

Since taking office a year ago, Thompson has been without an assistant secretary of health and a director for the Health Resources and Services Administration, the agency responsible for many programs that provide care for the indigent. In a matter of weeks, the surgeon general's office will be empty. The vacancies at the top have had a ripple effect; five NIH institutes, for instance, are without directors.

White House spokeswoman Anne Womack said that a search for "the best" candidates is difficult under normal circumstances but the terrorist attacks complicated the process even further. "The events of last year made us take a second look and take into consideration the new environment," she said. "We're looking for the best, and sometimes the best takes longer."

HHS spokesman Bill Pierce said that Thompson has great faith in the acting directors and that he recently sent the names of three prospective FDA commissioners to the White House. "The secretary believes these are very important positions," Pierce said. "You don't want to rush it for the sake of rushing it."

To a large extent, Thompson has tried to fill the gaps himself, personally negotiating a contract to purchase the anti-anthrax drug Cipro and deciding to offer an anthrax vaccine as an experimental treatment for thousands exposed.

That means Bush has sometimes lacked the guidance and credibility that come with a high-powered health team.

When he crafted a compromise on federal funding for stem cell research, the president relied heavily on Thompson and Jay Lefkowitz, a lawyer in the Office of Management and Budget who was new to the complex issue. Several researchers complained that they were left to implement a politically volatile policy with little opportunity to shape it.

During the anthrax crisis, a rotating cast of politicians, doctors and mid-level researchers presented what many viewed as a confusing, often contradictory, public health message.

Surgeon General David Satcher could have filled that role, said Michael Place, president and CEO of the Catholic Health Association. But because Satcher is a Clinton administration holdover, he lacked the authority to emulate Surgeon General C. Everett Koop's leadership during the AIDS epidemic.

Rep. James C. Greenwood (R-Pa.) said the administration did not want to nominate a director for NIH until Bush took a position on embryonic stem cell research.

"It's understandable they needed to get that resolved," he said. But four months after Bush announced his compromise, Greenwood recently wrote the White House "urging that appointments be made as quickly as possible at FDA, NIH and the other institutes."

The effects may not be felt immediately, Wyden said, but they could be far-reaching.

"If we waste several years and we see continued hemorrhage of scientific talent out of these agencies, we're going to pay dearly in the development of new therapies, new pharmaceuticals, bioterrorism, et cetera," he said.

From its 300-acre campus in Bethesda, the NIH oversees a $20 billion research operation. It has been in the vanguard of treatments and cures for heart disease, cancer and depression. Yet, two years after the departure of Harold Varmus, prominent researchers are still waiting to see who will take over the institute, said Elizabeth Marincola, executive director of the American Society for Cell Biology.

"Acting directors are in an untenable position," Marincola said. Without a director, it is difficult to recruit others to run research institutes, and the environment becomes "demoralizing" for the people working there, she added.

The FDA approves a vast array of new drugs, medical devices and food products. Products that account for 25 cents of every consumer dollar spent in the nation come under its purview. In coming months, it faces challenges on controversial matters such as dietary supplements, vaccines, the artificial heart and renewal of the Prescription Drug User Fee Act, a law in which drug companies subsidize the approval process.

"During this time, the pace of FDA approval of vital new drug and biotechnology products has slowed dramatically," a group of Massachusetts biotech executives wrote to White House Chief of Staff Andrew H. Card Jr. Other FDA projects "are also suffering from the lack of a clear administration position, which creates a political vacuum that inevitably reduces the industry's and the public's confidence in FDA."

All of this comes at a time when scientific progress is racing into new frontiers, Berg said. "What is so tragic about this is that the science is booming; there are an enormous number of opportunities," he said.