[PROVE] Trouble in Paradise?

[Guest guest]

[PROVE Note: Below are two recent articles highlighting shake-up and dissent at

the Centers for Disease Control involving vaccine and other programs. The first

article mentions how employees feel " cowed into silence " which is kind of ironic

when you consider this is how they respond routinely when they are presented

evidence that vaccines hurt children. The article mentions how employees are

having morale programs - it is hard to have any sympathy when countless families

are having " morale " issues trying to pick up the pieces when their previously

healthy children are injured or killed by vaccines pushed by the CDC. The second

NY Times article talks about how the " vaccine safety " (an oxymoron) program was

removed out of the National Immunization Program. The hard reality is no matter

how anybody tries to spin it is that this agency promotes vaccine programs that

accepts the sacrifice of some healthy children as necessary. That is

unacceptable and the one message parents should take from this is that putting

their trust in this agency and their recommendations has been and continues to

be a very risky proposition.]

http://www.washingtonpost.com/wp-dyn/articles/A10399-2005Mar5.html

Internal Dissension Grows as CDC Faces Big Threats to Public Health

By Rob Stein

Washington Post Staff Writer

Sunday, March 6, 2005; Page A09

The Centers for Disease Control and Prevention is being roiled by internal

dissension as the nation's top public health agency is facing such unprecedented

threats as bioterrorism, a potential flu pandemic and the obesity epidemic, say

current and former officials and several outside experts.

The Atlanta-based agency has been thrown into turmoil by a combination of

factors, including the upheaval of a drawn-out restructuring, the departure of

dozens of its most respected scientists, concerns about political interference

and a pending budget cut of nearly $500 million, they say.

Although the impact remains a matter of debate, the uproar is causing widespread

alarm among public health authorities, and some say the deep discord may have

already contributed to several recent crucial missteps, including confused

messages during this winter's flu vaccine shortage, an embarrassing error in a

highly publicized estimate of obesity's toll, and a failed program to vaccinate

hundreds of thousands of front-line health workers against smallpox to prepare

for a possible bioterrorist attack.

Last week, an independent panel of the National Academy of Sciences criticized

the CDC for failing to provide clear leadership in the smallpox vaccination

campaign and suggested that political " constraints " imposed by Washington played

a role.

The tumult has been exacerbated, say some current and former agency employees,

by CDC Director L. Gerberding's management style. Her critics say she

tends to squelch open discussion and has failed to protect the agency from the

specter of deep budget cuts and undue influence from Washington.

Taken together, the turbulence at the agency has created a " crisis of

confidence " and an atmosphere of fear in which employees feel " cowed into

silence, " wrote one top CDC official, A. Keegan, in a widely circulated

memo to Gerberding and other top leaders.

" I think there is a crisis, " added Keegan, deputy director of the global

immunization division, in a phone interview. " Clearly there is a real problem

with morale. People are feeling tired and frustrated and don't know where we're

headed. "

Leadership Disputes Claims

The claims of widespread discontent and demoralization are disputed, however, by

the agency's leadership and other CDC employees and supporters outside the

agency.

" There are always people who have a hard time accepting change, and we are

interested in ideas in how we help people deal with that, " Gerberding said in a

recent phone interview. " But there are a lot of people in the agency who are

excited about this and have jumped in with both feet. "

Although difficult in the short term, the changes will forge a much more

efficient, modern agency, she and her supporters say.

" We have a responsibility to really learn how we can do our jobs and accomplish

our health protection mission in a world that has undergone some pretty profound

changes, " Gerberding said.

Founded in 1946, the CDC has grown into an $8 billion agency with more than

9,000 employees who play crucial roles in all aspects of public health:

stanching the spread of AIDS, investigating disease outbreaks, protecting

workplace safety, reducing domestic violence, vaccinating children and guarding

against bioterrorists.

The main source of unhappiness at the agency stems from the Futures Initiative,

the first major reorganization of the CDC in decades. Launched in June 2003, the

plan is designed to transform the agency by shifting responsibilities,

consolidating functions, fundamentally redrawing lines of authority and making

the agency much more nimble in a crisis. One of the biggest changes would create

four powerful coordinating centers intended to break down barriers that prevent

the CDC's many centers, programs and offices from working efficiently together.

But the reorganization has dragged on for nearly two years, leaving many

employees exhausted, disillusioned and impatient, Keegan and others said.

" Are we seeing efficiencies? " Keegan asked. " It doesn't feel more efficient.

There's frustration that after two years we're still waiting for a payoff. "

Some employees say much of the restructuring has been confusing, misdirected and

counterproductive. One controversial change, for example, moves responsibility

for vaccine safety out of the National Immunization Program.

" CDC folks are a very dedicated bunch . . ., [but] it's gone from dedication to

make change to being aghast at the process and the changes being made, " one

senior official said. Among the 34 people interviewed for this article, this

official and a number of other current and former CDC staff spoke on the

condition they not be identified because of their intense loyalty to the agency

and, in some cases, because they fear retribution.

" Growing Pains "

Other employees said the reorganization has been open, inclusive and positive.

" This is exactly what the agency needs to be doing, " said Goodman, a

27-year veteran who co-directs the agency's public law center. The complaints,

he said, are just " growing pains. "

But her critics said Gerberding has let the process drag on too long while

jumping too quickly into the spotlight on high-profile issues, reeling from one

crisis to the next, and relying too much on a close coterie of top aides.

" I would describe it as a kind of Alice in Wonderland environment where the CDC

director is like the Queen of Hearts, " the senior official said. " You know, 'Off

with their heads.' It's a very autocratic and unpredictable environment. "

An internal report on the widely publicized statistical mistake in the obesity

study found that some scientists had questioned the calculations but did not

push their concerns because " they did not feel it would make any difference, "

because Gerberding was one of the study's authors.

By some estimates, nearly 40 top managers have left or are planning to,

motivated partly by dissatisfaction with the changes and partly by the

coincidence that a generation of CDC officials is becoming eligible for

retirement. The result is that many top jobs have been filled by officials in an

acting capacity, including five of the CDC's seven long-standing centers plus

the National Immunization Program and the newly created National Center for

Health Marketing.

The reorganization and departures come against a backdrop of complaints by some

that the agency's historical independence has been seriously compromised. The

AIDS prevention program in particular has been dogged by controversy, with

scientists arguing that too much emphasis was being put on promoting abstinence,

instead of condom use and sex education.

" There's an ideological focus that's inconsistent with the science, " said

Margaret Scarlett, who left the CDC's AIDS program in 2001 after 15 years with

the agency. " Political ideology is being substituted for science. "

National Academy Criticism

In its report, the National Academy panel said the smallpox vaccine effort fell

far short at least in part because the agency failed at answer key concerns

about the program's necessity and safety.

" The ability of the Centers for Disease Control and Prevention to speak

authoritatively as the nation's public health leader, on the basis of the best

available scientific reasoning, was severely constrained, presumably by the top

levels of the executive branch, " the panel wrote.

Gerberding immediately rejected the critique. In an earlier interview, she had

disputed the charges that the agency has allowed politics to influence science,

that she has failed to protect the agency from damaging budget cuts, stifled

dissent or that any of the problems have hampered the agency's work.

" I think we'll get through this difficult period of change and end up in a

situation where we're concentrating on our job, which is to protect people's

health, " she said.

Gerberding acknowledged that some people may be leaving because they are unhappy

with the changes but said there is a new generation of qualified scientists

waiting to move up.

" It's very sad to see some of our revered leaders move on, " she said. " But it's

also an opportunity to bring in newer and younger people. It's healthy sometimes

to get new people with new ideas. "

Current and former officials disagree on whether the turmoil is affecting the

CDC's performance, but one informal analysis circulating inside the agency

suggests the number of new research projects and published scientific papers has

fallen as retirements have spiked.

Outside authorities were mixed in their assessments.

" The CDC is going through a change that's long overdue, " said Osterholm,

a leading infectious-disease expert at the University of Minnesota.

Others, while saying they remain highly supportive both of the agency and the

need for change, said the depth and duration of the discord was unusual and

alarming.

" There's a very intense malaise and demoralization among the CDC staff, " said

Alfred Sommer, dean of the s Hopkins Bloomberg School of Public Health. " The

CDC is our thin gray line when it comes to public health, and so you've got to

be concerned. "

Local, state and national public health leaders said they are especially worried

that the reorganization is affecting their ability to work with the agency and

that the budget cuts would mean a loss of hundreds of millions of dollars for

programs to boost bioterrorism preparedness, immunize children, promote good

health habits and fight chronic health problems.

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http://www.nytimes.com/

February 25, 2005

Health Agency Splits Program Amid Vaccination Dispute

By ANAHAD O'CONNOR and GARDINER HARRIS

Responding to growing concerns about its ability to monitor the side effects of

vaccines, the Centers for Disease Control and Prevention decided last week to

separate its national immunization program, which advocates vaccination, from

its vaccine safety branch, which monitors the potential risks of the vaccines.

The action comes at a time of increasing public outcry over the government's

handling of drug safety issues. Earlier this month, the Food and Drug

Administration announced that it would create a board to advise it on drug

complications and to warn patients about unsafe drugs.

Critics of the disease-control agency have argued for some time that the

advocacy nature of its immunization program hinders its ability to monitor and

investigate any adverse reactions to vaccines.

Much of the pressure has come from lawmakers and parents of autistic children,

who are concerned about a possible link between rising rates of autism and a

mercury preservative, thimerosal, once widely used in childhood vaccines. They

have argued that the agency's dual role in promoting vaccines and overseeing

their safety is a serious conflict of interest.

The decision to separate the offices was announced last Friday, a day after a

panel of medical experts urged the agency to improve access to a database of

patient information that is at the center of a dispute over whether vaccines can

cause autism.

Dr. L. Gerberding, the director of the agency, said that shifting the

safety branch was intended to improve its " credibility and capability, " and that

the branch would now be led by Dr. Dixie E. Snider Jr., the agency's chief of

science.

" We believe the best practice for the safety monitoring program is to keep it in

a separate locus from the large-scale program, " Dr. Gerberding said.

Representative Dave Weldon, Republican of Florida and a physician who has a

strong interest in autism issues, called the move " a step in the right

direction. "

" You can't have an organization whose primary charge is getting kids vaccinated

also have credibility in looking at side effects, " Dr. Weldon said. " Their

primary mission is getting lots of kids vaccinated. I don't think they should be

the same people looking at safety. "

But Dr. Offit, who was a member of a federal advisory panel on immunization

practices, said the idea that the agency would be less concerned about whether

vaccines were safe than with seeing that every child received a shot was absurd.

" The notion has been that this is the fox guarding the henhouse, " said Dr.

Offit, who is also a pediatrician at the Children's Hospital of Philadelphia.

" That's not true. They care as much about vaccines being safe as they care about

them working. They wouldn't recommend them unless they felt the benefits clearly

outweighed the risks. "

But Dr. Weldon and others say the agency has made it difficult to assess what

those risks might be, particularly as they relate to autism.

Their concerns were echoed on Feb. 17 by a panel of medical experts assembled by

the Institute of Medicine, an arm of the National Academy of Sciences. The

committee recommended that the C.D.C. ease some restrictions on outside

scientists who want to use its heavily guarded Vaccine Safety Datalink, which

holds more than seven million medical records that the agency uses to monitor

adverse reactions to vaccines.

Dr. Verstraeten, a former researcher at the agency, used the database to

carry out a large study that was published in 2003. Many scientists have said

the study shows no statistical link between thimerosal and autism.

But Dr. Weldon and the parent groups, through the Freedom of Information Act,

later obtained an earlier draft of the study that had not been made public. The

early findings did suggest a relationship between exposure to thimerosal and

some developmental delays, and Dr. Weldon and the groups say the results were

deliberately " watered down. "

Two outside researchers, Dr. Mark Geier and his son, Geier, who were

expert witnesses for parents seeking damages from the National Vaccine Injury

Compensation Program, have fought for access to the database. The agency has

been hesitant, fearing that doing so could violate the privacy of those whose

medical histories are in it.

Dr. E. Fienberg, a professor at Carnegie Mellon University and a member

of the committee that weighed in on the dispute, suggested the Geiers be granted

further access.

Now, outside researchers who want access must submit a proposal and obtain

permission from the more than a half-dozen health maintenance organizations that

provide the centers with their medical records. The report determined that the

inquiry process should be streamlined, and listed steps the disease-control

agency could follow to balance patient privacy with the need to open the

database to some outside researchers.

Tom Skinner, a C.D.C. spokesman, said his agency would consider all of the

committee's recommendations and work to carry them out.

" We're going to continue to deliberate on them as we strengthen our vaccine

program, " Mr. Skinner said. " All of this supports our desire to continue to

place a high priority on vaccine safety. "

The agency has come under fierce criticism for its handling of the preliminary

findings from the 2003 Verstraeten study. Dr. Weldon has alleged wrongdoing,

pointing to transcripts of a private meeting where agency staff members shared

Dr. Verstraeten's findings with representatives of the vaccine industry,

government officials and physicians.

The study's authors have argued that later phases of the study were intended to

replicate earlier findings, but found no association between thimerosal and

developmental delays. Numerous epidemiological studies conducted in Europe have

also shown no link between autism and vaccines containing thimerosal.

Anahad O'Connor reported from New York for this article, and Gardiner

from Washington.

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Dawn

PROVE(Parents Requesting Open Vaccine Education)

prove@... (email)

http://vaccineinfo.net/ (web site)

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PROVE provides information on vaccines, and immunization policies and practices

that affect the children and adults of Texas. Our mission is to prevent vaccine

injury and death and to promote and protect the right of every person to make

informed independent vaccination decisions for themselves and their family.

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This information is not to be construed as medical OR legal advice.

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