Mon, 9 Oct 2006 20:53:04 EDT
FDA lacks funds for drug safety tests
Only $1.6 million budgeted for studies of medications already on market
By Ricardo Alonso-Zaldivar
October 7, 2006
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 might be halted in midstream.
The reason: The agency doesn't have the money to finish it.
The threat to the study, as revealed in documents and interviews, stems from the chronic shortchanging of the nation's drug safety program.
Can't keep up 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 budgeted only $1.6 million for such safety studies of medications already on the market, and that figure is scheduled to drop to $900,000 in the coming year. Outside experts estimate that the agency needs $20 million to $100 million a year to conduct such studies.
Recently, three former secretaries of the Department of Health and Human Services sounded a public alarm about what they see as a dangerous squeeze on the overall FDA budget.
Plea for money Tommy G. Thompson, who served in President Bush's first term; Donna Shalala, who served under President Bill 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 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 in 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 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 whether 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."
Ricardo Alonso-Zaldivar writes for the Los Angeles Times.
