October 9

FDA Suspends ADHD Drug Safety Study-Approves Risperdal for Autistic Children Without Public Hearing

On Friday, October 6, FDA approved expanded use of Johnson & Johnson’s drug, Risperdal (risperidone) approved for treating psychosis in adult patients with schizophrenia and manic-depression (for short term use). FDA approved its use to control aggression and other bad behavior in autistic children. 

A body of scientific evidence–from both pre-and post-marketing study reports—shows  that the drug increases the risk of severely disabling adverse drug effects and premature death in adults and children for whom it has been used off-label.

The drug label indicates: “Safety and effectiveness in children have not been established.”  This exceptionally hazardous drug—another within that class of so-called ‘atypical antipsychotics’ is Eli Lilly’s Zyprexa (olanzapine)—carries a black box warning that Risperdal “increased mortality in the elderly.” Most deaths primarily due to “cardiovascular (e.g., heart failure, sudden death). ” [1]

The drug has no known therapeutic benefit for autism: it is used as a chemical restraint to disable children and control their behavior. J & J acknowledged: “The anti-psychotic drug is not a cure for autism, nor does it treat the condition itself.” But Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research (CDER), told The Los Angeles Times: "This approval should benefit many autistic children as well as their parents and other caregivers." 

Dr. Galson and the CDER leadership apparently don’t care at all about the fact that FDA’s MedWatch received reports that at least 45 children have been killed by Risperdal and the other ‘atypicals’ between 2000 and 2004. [2] The youngest, a four years old, died of diabetes complications. www.ahrp.org/cms/content/view/158/52

Nor does Dr. Galson or his CDER colleagues care about the children who have been permanently disabled and disfigured by drug-induced tardive dyskinesia (TD) [2]

Why did the FDA fail to hold public hearings before issuing approval for this irresponsible change in label that will result in preventable harm to children?  Do increased drug sales supersede ALL other considerations?

Underscoring FDA’s deviation from its public mission is the following news item:
FDA announced that it suspended a safety study of drugs used to treat ADHD that an FDA advisory panel urged the agency to undertake when evidence suggested the drugs increased the risk of sudden death from stroke and cardiac arrest. “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.”

Researchers with limited resources have been trying to determine whether these drugs predispose patients to heart attacks and sudden death. That is because FDA—which has authority to order manufacturers to conduct such studies has failed to exercise its authority. "The makers of these agents,” as cardiologist, Dr. Steven Nissen of the Cleveland Clinic said, “have no incentive to study the hazards of their own drugs. Therefore, the FDA [ ] likely represents the only entity capable of objectively assessing the safety of the ADHD drugs." 

But, as the authoritative Institute of Medicine report shows, whenever a collision exists between safety objectives and corporate industry objectives, drug companies can always count on their lapdogs at the FDA to sacrifice safety. [3] www.ahrp.org/cms/content/view/344/55
While claiming the agency lacked money, “FDA officials declined to discuss problems with funding for drug safety.” Furthermore, the LAT reports: “Meanwhile, the 90-person drug safety office is reeling from a surge in reports on medication side effects. The number of such "adverse event" reports jumped from about 250,000 in 2000 to more than 450,000 in 2005.”

And those numbers reflect but the tip of an iceberg: only 1% to 10% of actual adverse drug events suffered by American consumers are reported to FDA’s MedWatch.


  1. Risperdal label warnings include: neuroleptic malignant syndrome… hyperglycemia and diabetes mellitus…cardiovascular adverse events…potential for cognitive and motor impairment…judgment, thinking…priaprism… Orthostatic Hypotension.”
    Frequent (occurring in 1 in 100) include: anxiety, psychosis, depression, agitation, nervousness, paranoid reaction, delusion, apathy. Adverse events that occurred Infrequently (between 1/100 and 1 /1,000): anorexia, impaired concentration, impotence, emotional lability, manic reaction, decreased libido, increased appetite, amnesia, confusion, euphoria, depersonalization, paroniria, delirium, psychotic depression.
    See: http://www.fda.gov/cder/foi/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf

  2. See series of reports by Marilyn Elias. New Anti-Psychotic Drugs Carry Risks for Children, USA Today, May 2, 2006 www.usatoday.com/news/health/2006-05-01-atypical-drugs_x.htm ; www.usatoday.com/news/health/2006-05-01-kids-overprescribe_x.htm ; www.ahrp.org/cms/content/view/158/52
    3. Institute of Medicine Report: The Future of Drug Safety: Promoting and Protecting the Health of the Public: www.iom.edu/CMS/3793/26341/37329.aspx

Contact: Vera Hassner Sharav
FDA OKs Drug to Treat Autism Symptoms
October 6, 2006

WASHINGTON — A Johnson & Johnson drug received expanded federal approval Friday to treat aggression and other symptoms of autism in children.

The new use for Risperdal is to treat irritability associated with autistic disorder, including temper tantrums, deliberate self-injury and aggression in children and adolescents, ages 5 to 16.  The approval is the first for the use of a drug to treat behaviors associated with autism in children, the Food and Drug Administration said.
Risperdal, first approved by the FDA in 1993, has been used to treat schizophrenia and bipolar disorder in adults.  The anti-psychotic drug is not a cure for autism, nor does it treat the condition itself, but it may provide relief for some children, according to Johnson & Johnson.

Autism is a complex developmental disability. It typically appears during a child’s first three years of life, and it affects communication, social interaction and creative or imaginative play. "This approval should benefit many autistic children as well as their parents and other caregivers," said Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research.

Two eight-week trials involving 156 children between the ages of 5 and 16 showed that those given Risperdal achieved significantly improved scores for certain behavioral symptoms of autism compared to those given dummy pills, the FDA said.

In 2005, the FDA declined to expand its approval of Risperdal, also known as risperidone, to include autism.

The most common side effects of Risperdal include drowsiness, constipation, fatigue and weight gain.

Food and Drug Administration: http://www.fda.gov/

FDA Budget Malnourished: A study of ADHD drug risks may be halted as the agency struggles to keep up with demands.
By Ricardo Alonso-Zaldivar October 7, 2006

WASHINGTON — When scientific advisors urged the Food and Drug Administration in February to put a strong warning about suspected cardiovascular 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 revealed in documents and interviews, stems from 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 budgeted only $1.6 million for such safety studies of medications already on the market, and that number 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 Health and Human Services sounded a public alarm about what they saw as a dangerous squeeze on the overall FDA budget. Tommy G. Thompson, who served in President Bush’s first term; Donna Shalala, who served under President Clinton; and Louis W. Sullivan, who served under President George H.W. Bush, joined consumer and industry groups in calling on the administration to substantially boost — perhaps double — the agency’s $1.5-billion annual budget, which has increased only modestly in recent years.

FDA officials declined to discuss problems with funding for drug safety, saying the issue was under internal review. In a statement, the agency acknowledged that more money was needed for safety and noted that funding to complete the ADHD study had "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 changes. 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 $2 million to $3 million. About $1 million has been committed. By analyzing the records of thousands of individuals, outside medical researchers have been trying 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."

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 on medication side effects. 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 of 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 staffers 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 had 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 made an average of $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, chairwoman 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."

Meanwhile, despite the uncertainty over funding for the ADHD study, researchers are continuing work on it.  They plan to use several medical databases to try to address three key issues: whether there is a link between ADHD drugs and higher rates of heart attack and sudden death in children; whether such a risk exists for adults; and whether there is a link between ADHD drugs and heart-rhythm abnormalities in children.

They have designed the study, but without more money won’t be able to determine whether these popular drugs can lead to heart attacks.   "That’s a very important question," said Laurel Habel, an epidemiologist at the Kaiser Foundation Research Institute in Oakland, which is participating in the study. "These drugs are being prescribed for a large and growing number of children, and they are also being prescribed to a growing number of adults. And, in general, they are medications that are taken for the long term."


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