FDA suffers from administration attention deficit
Ricardo Alonso-Zaldivar

WASHINGTON -- When scientific advisers urged the Food and Drug
Administration in February to put a strong warning about suspected
heart risks on attention deficit drugs taken by millions of children
and adults, agency officials said more clinical evidence was needed.

Now, the FDA-funded study meant to authoritatively answer questions
about the drugs for attention deficit-hyperactivity disorder may be
halted in midstream. The reason: the agency doesn't have the money to
finish it.

The threat to the study, as disclosed in documents and interviews,
stems from the chronic shortchanging of the nation's drug safety
program. It is one symptom of a federal agency increasingly
constrained by a budget that has failed to keep up with costs. This
crunch is even more dire in the food division, which tries to keep
tainted foodstuffs from supermarket shelves.

Even as concerns grow, the agency has budged only $1.6 million for
such safety studies of medications already on the market; and that
sum is scheduled to drop to $900,000 in the coming year. Outside
experts estimate the agency needs $20 million to $100 million a year
to conduct such studies.

Recently, three former secretaries of Health and Human Services
sounded a public alarm about what they see as a dangerous squeeze on
the overall FDA budget. Tommy Thompson, who served in President
Bush's first term; Donna Shalala, who served under President Clinton;
and Louis Sullivan, who served under President George H.W. Bush,
joined consumer and industry groups calling on the administration to
substantially boost -- and perhaps even double -- the agency's $1.5
billion annual budget, which has seen only modest increases in recent
years.

FDA officials declined to discuss the problems with funding for drug
safety, saying the issue is under internal review. In a statement,
the agency acknowledged that more money is needed for safety and
noted that funding to complete the study on attention deficit-
hyperactivity disorder -- ADHD -- "has not yet been identified."

A special fact-finding panel of the Institute of Medicine recently
put the troubles in blunt terms in a report that called for
significant FDA reforms. Funding for drug safety is "especially
inadequate (and) resource limitations have hobbled the agency's
ability to improve and expand this essential component of its
mission," the panel concluded.

FDA officials estimate the study of ADHD medications, including such
well-known brands as Ritalin and Adderall, will cost between $2
million and $3 million. About $1 million has already been committed
to the investigation, which is being conducted by outside medical
researchers.

By analyzing the records of thousands of individuals, the researchers
will try to determine if the medications predispose patients to heart
attacks and sudden death. Most ADHD drugs are derived from powerful
stimulants. They help patients concentrate, but they also raise blood
pressure, a major risk factor for heart disease and stroke. The
medications, once given primarily to children, are increasingly
prescribed for adults -- a population more susceptible to heart
problems. About 2.5 million children and 1.5 million adults now take
such medications.

"If the FDA lacks the resources to complete the study of
cardiovascular risks of ADHD drugs, the consequences can have a
profound adverse impact on public health," said Dr. Steven Nissen,
chairman of cardiovascular medicine at the Cleveland Clinic. "The
makers of these agents have no incentive to study the hazards of
their own drugs. Therefore, the FDA will likely represent the only
entity capable of objectively assessing the safety of the ADHD drugs."

The ADHD study is not the only example of a patchwork system.

The FDA bought -- at a cost of $500,000 a year -- a British database
that is considered a state-of-the-art tool for drug safety research.
The General Practice Research Database contains complete medical
records on 4 million patients that can be mined for information on
reactions to drugs.

But the FDA has acknowledged that its drug safety office doesn't have
enough professionals -- epidemiologists, biostatisticians and
computer programmers -- to take full advantage of the database.

Meanwhile, the 90-person drug safety office is reeling from a surge
in reports filed on bad side effects of medications. The number of
such "adverse event" reports jumped from about 250,000 in 2000 to
more than 450,000 in 2005. The trend reflects greater use of
prescription drugs, growing awareness about their risks and
improvements in the reporting system.

"We have to do difficult triage about which ones we are going to
follow up on," said an FDA official closely involved with the
agency's budget who asked not to be identified because of the
sensitivity of discussions within the Bush administration. "Our
funding is just not robust enough for scientific research." Fully
funding the ADHD risk study would mean "we wouldn't be able to do too
many other studies," the official added.

The FDA's budget crunch has also hurt its ability to safeguard fresh
produce, some critics say. That has become an issue in the aftermath
of the E. coli outbreak traced to California spinach. The number of
inspectors and field office staff has been cut from 2,217 in 2003 to
about 1,960.

"The agency is like a fire department running around with a little
fire extinguisher," said Michael Jacobson, director of the Center for
Science in the Public Interest, a nutrition advocacy group. "The
money situation for foods is probably worse than it's ever been."

Earlier this year, the FDA's food division announced that budget
pressures have forced cuts in its headquarters workforce from 950 in
2003 to fewer than 850, with further reductions expected.

The FDA has "been presented with unique challenges, and we will not
be able to take on the same large number of objectives we have
identified in previous years," Robert E. Brackett, director of the
food division, wrote in an unusually candid letter to consumer and
industry groups. "The challenges are likely to continue (in 2007) and
beyond for domestic agencies in the federal government."

The agency's budget challenge has three facets, outside experts and
agency officials say.

First, modest annual increases for the FDA have not kept up with
escalating salaries for its doctors, pharmacologists,
epidemiologists, and other professionals. For example, experts in the
FDA's Center for Drug Evaluation and Research averaged $70,000 in
1997 but now command salaries of $140,000 to keep up with industry.

A recent internal FDA analysis estimated that the 2006 budget would
have needed to be $2.2 billion -- not $1.5 billion -- just to keep
pace with increases in personnel costs.

Second, the post-market drug safety program -- with a few exceptions -
- is not allowed to tap into user fees that pharmaceutical companies
pay the agency for the review of proposed new drugs. The user fees
add about $400 million a year to the FDA's $1.5 billion budget.

Finally, compared with funding for the National Institutes of Health,
which sponsors cutting-edge medical research, securing more money for
the FDA has been a low priority for the administration and Congress.
The NIH budget has increased from $20.5 billion in 2001 to $28.6
billion.

"There has been a dramatic increase in the attention focused on NIH,
and we believe similar attention needs to be given to the FDA," said
Sheila Burke, chair of the Institute of Medicine panel that recently
reported on drug safety. "The center of that effort has to be an
increase in resources. There is no question that it needs to be done."