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Independence of CDC Scientists in Question

Image has not been found. URL: /wp-content/uploads/2008/09/gerberding.jpgCDC Director Julie Gerberding testifies about a vaccine recall before Congress, November 2007. (Associated Press)

Over the past four years, the office at the Centers for Disease Control that is responsible for vaccine safety has undergone numerous leadership changes, internal conflicts and a flight of senior scientists.

Some departing scientists and outside experts have charged that senior CDC officials are failing to give the office the independence it requires to investigate possible harm from vaccines. The accusations have come at a time when the number of routine childhood shots is swelling — preschoolers now get 10 separate types of shots in most states, double the number in 2000. New vaccines are being administered to teenagers as well. In the latest addition to the vaccine schedule, a CDC panel on Wednesday recommended that all children up to 18 years of age receive yearly flu vaccination.

Science.jpg
Science.jpg

Illustration by: Matt Mahurin

The bitterness and disputes at the Immunization Safety Office, moreover, are par for the course at the CDC under the leadership of Dr. Julie Gerberding, who took over in 2002 after handling the agency’s response to the anthrax mailings.

In more than a dozen interviews, senior CDC scientists complained that Gerberding has driven away the agency’s best scientists while embittering many of its 7,000 employees. She implemented a sweeping reorganization that centralized control and boosted public relations efforts while introducing expensive, often unworkable new management techniques. The officials charge that the once-independent CDC has been brought under tighter political control from the White House.

In 2005, five of the agency’s last six directors charged in an unprecedented letter that Gerberding’s management and politicization of the agency were harming CDC’s unparalleled international reputation in the field of public health. Daily complaints on a venting website provide a window into a dispirited, demoralized workforce.

A half-dozen senior scientists told The Washington Independent that they now spend roughly a third of their time on administrative tasks that previously took up no more than 10 percent. In the view of many, Gerberding took a functioning, vibrant agency and subjected it to a needless purges and restructuring. In some cases, scientists who champion unpopular positions, like non-abstinence forms of birth control, have been muzzled. For the most part, however, the main complaint is that the administration is burying them in red tape.

Spokespersons for Dr. Gerberding did not return two phone calls. In the past, Gerberding has acknowledged poor morale among some CDC employees, but said the restructuring, while painful, was necessary to bring CDC into the 21st century.

A half-dozen senior scientists told The Washington Independent that they now spend roughly a third of their time on administrative tasks that previously took up no more than 10 percent.

“We’re doing the best we can,” said one longtime CDCer. “But we’re tired. Everyone’s hoping things will change. There’s a lot of angst and unhappiness and a lot of things that don’t work. But to tell you the truth, I can’t say whether the reorganization succeeded, because I still don’t know what its objective was. Julie Gerberding wanted a centralized chain of command, and she’s gotten that. She didn’t like a lot of the leadership, and she got rid of them. They were too independent. So, I guess it’s worked for her.”

But has it worked for the rest of America?

Investigators in the office of Sen. Charles Grassley (R-Iowa) found that poor morale and an exodus of high-profile scientists — 8 of the top 10 CDC scientists have left since Geberding took office — had damaged the agency’s’ ability to respond in a major public health crisis. The investigators also looked into charges that the agency couldn’t quantify how $3.8 billion in spending had improved bioterrorism and pandemic preparedness.

In a separate probe, Rep. Bart Stupak (D-Mich) criticized the agency last year for failing to take more aggressive action against hospital infections that kill more than 100,000 patients annually.

Dr. William Jarvis, who left the CDC in 2003 after a period in charge of fighting hospital infections, charged that a reorganization of his division, ordered by Gerberding, had created “five years of dysfunction. During that time, an enormous number of qualified people left.”

While it is difficult to find other direct evidence that turmoil in the agency is affecting public health, many scientists there speak darkly of the dumbing down of the CDC. Too much emphasis is being placed on delivering a unified, pro-CDC message, and not enough on independent inquiry, these scientists charged, echoing complaints heard throughout the government’s professional corps.

“The CDC was a rogue dog, a bunch of hippies traveling around the world doing neat things and speaking out. They fostered that kind of against-the-grain thinking. And it’s necessary in public health,” one former CDCer said. “You have to go against conventional thinking. You can’t make the CDC a business model, and that’s what Julie has tried to do. She’s run out everybody who represented the old way.”

These effects have been visible within the vaccine safety office, which until 2004 was led by a charismatic Taiwanese immigrant named Robert T. Chen. Chen aggressively expanded vaccine safety measures to include a linked nationwide database of 3 percent of the country’s population that could be used to investigate possible harm from vaccines. The database was key to the 1998 discovery that a new rotavirus vaccine, produced by Wyeth Co., apparently caused a severe bowel disorder in about 1 in 10,000 infants who received it. The vaccine was withdrawn.

Chen rubbed some of his superiors the wrong way, partly because of a blunt speaking style but more fundamentally because of his willingness to put the interests of public health ahead of those of the CDC. It was a combination of personal and philosophical conflicts that led to him being removed from his job. He now works in HIV prevention at CDC.

In 1999, scientists at the Food and Drug Administration noticed that a preservative called thimerosal, contained in two new vaccines and one old one, might cumulatively be exposing babies to harmful levels of organic mercury. Despite the misgivings of some immunization officials, Chen’s network of vaccine safety scientists leapt to investigate this theory.

Within a few months, the CDC-directed team put together a study that showed a faint signal of harm to children’s neurological function from the mercury in thimerosal.

After years of further study, consensus developed that thimerosal had probably been harmless at the dosages used. But in the meantime, activist parents had convinced members of Congress that the initial CDC study was being covered up because it showed that vaccines caused autism. Amid the controversy, many parents stopped vaccinating their children, and thousands of parents filed lawsuits.

Within the CDC, the thimerosal story created bitterness. Some had opposed the initial thimerosal study because they feared that, for reasons having to do with statistical probability, it was likely to produce a signal of harm even if none existed — a suspicion that may have been correct. They felt the vaccine safety scientists needed to be reined in.

Others praised Chen’s office for having had the guts to ask tough questions about a medical procedure that most Americans equate with apple pie and mother’s milk. The problem was that in looking for possible harm from vaccines, Chen’s agenda didn’t exactly mesh with the center he was part of, then called the National Immunization Program, whose overall goal was to assure the vaccination of as many American children as possible.

In the internecine struggle that ensued, Chen was removed from his job. But CDC Director Gerberding, in a nod to two GOP congressmen concerned about the alleged cover-up, moved vaccine safety activities out of the immunization program and into her own office. Some suggested that the agency might better be removed from CDC entirely.

In the past four years, at least eight other top scientists have left the safety division — most of them going to other parts of the CDC.

In 2006, the CDC hired a new vaccine safety director, Robert L. Davis, a respected epidemiologist who had worked in the CDC safety network from his position at the University of Washington. But Davis lasted only one year, after pitched battles with Tanja Popovic, whom Gerberding had named to replace a more seasoned scientist as the agency’s chief science officer.

Putting vaccine safety into Gerberding’s office seems to have largely crushed it, rather than increasing its independence, Davis said. “They fought tooth and nail to keep the Immunization Safety Office in the CDC,” he said, “but in retrospect, because of the desire to control the message, the ISO’s independence has been suffocated.” Davis complained that his superiors were overly meddlesome in setting the agenda of his office.

In the past four years, at least eight other top scientists have left the safety division — most of them going to other parts of the CDC. (Dr. John Iskander, the acting safety office chief who replaced Davis, noted that he has hired five new scientists with comparable credentials). Centralized control over the safety office, in the view of many interviewed by The Washington Independent, compromises public trust that the government is doing its utmost to prevent harm from vaccines.

“What’s really sad about it is, you had a few people with the power to eviscerate what I think most of the American public wants,” Davis said. “To me that was really, really shocking.”

To be sure, vaccine safety work continues. One study, presented at the Advisory Committee on Immunization Practices on Feb. 28, found an additional seizure in each 2,000 children who received ProQuad, an all-in-one measles, mumps, rubella and chickenpox vaccine, compared to those who get chickenpox in a separate shot. Though this type of seizure is generally benign, the report led the committee to stop recommending ProQuad as the preferred vaccine.

Iskander acknowledged, in an interview, that the increased vaccine load has posed challenges. He is focusing on a strategic plan that he hopes will enable the vaccine safety office to focus its resources more effectively. Whether that will happen remains to be seen.

“Studies are being done,” said a senior vaccinologist outside the CDC. “But you need people with judgment based on a strong science and methodology background. And, honestly there’s nobody there.

“If you had stronger and better CDC leadership, they could have prevented some of this infighting,” the scientist added. “There have been too many decisions based on politics and not the best science in the last six years.”

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