Monthly Archives: September 2008

U.S. children three times more medicated

United Press International

U.S. children are about three times more likely to be prescribed psychotropic medications such as antidepressants than children in Europe, researchers said.

The study, published in the journal Child and Adolescent Psychiatry and Mental Health, said the differences may be due to regulatory practices and cultural beliefs about medications and emotional and behavioral problems.

Study leader Julie Zito of the University of Maryland led U.S., German and Dutch researchers who investigated prescription levels in three countries.

“Antidepressant and stimulant prevalence were three or more times greater in the United States than in the Netherlands and Germany, while antipsychotic prevalence was 1.5 to 2.2 times greater,” Zito said in a statement.

The researchers said the differences may be partly due to different diagnostic classification systems.

“The U.S. trend of increasing bipolar diagnosis in children and adolescents does not reflect European practice,” the study authors said in a statement. “Government cost restrictions in Europe, the larger number of child psychiatrists per capita in the United States and the use of two or more different psychotropic drugs in a single year in U.S. children” are possible explanations.

Direct-to-consumer drug advertising, common in the United States, is also likely to account for some of the differences, Zito said.

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Risks Found for Youths in New Antipsychotics

New York Times
By BENEDICT CAREY

A new government study published Monday has found that the medicines most often prescribed for schizophrenia in children and adolescents are no more effective than older, less expensive drugs and are more likely to cause some harmful side effects. The standards for treating the disorder should be changed to include some older medications that have fallen out of use, the study’s authors said.

The results, being published online by The American Journal of Psychiatry, are likely to alter treatment for an estimated one million children and teenagers with schizophrenia and to intensify a broader controversy in child psychiatry over the newer medications, experts said.

Prescription rates for the newer drugs, called atypical antipsychotics, have increased more than fivefold for children over the past decades and a half, and doctors now use them to settle outbursts and aggression in children with a wide variety of diagnoses, despite serious side effects.

A consortium of state Medicaid directors is currently evaluating the use of these drugs in children on state Medicaid rolls, to ensure they are being prescribed properly.

The study compared two of the newer antipsychotics, Zyprexa from Eli Lilly and Risperdal from Janssen, with an older medication and found that all three relieved symptoms of schizophrenia, like auditory hallucinations, in many young patients. Yet half of the children in the study stopped taking their drug within two months, either because it had no effect or was causing serious side effects, like rapid weight gain. The children receiving Zyprexa gained so much weight that a government oversight panel monitoring safety ordered that they be taken off the drug.

The long-anticipated study, financed by the National Institute of Mental Health, is the most rigorous, head-to-head trial of the drugs in children and adolescents with this disorder.

About three million Americans suffer from schizophrenia, and perhaps 40 percent first show symptoms in their teens or earlier.

“This is really a landmark study, because these newer drugs have been around for 12 years or so now, and there were fundamental questions for which we really didn’t have answers,” said Dr. Sanjiv Kumra, director of the division of child and adolescent psychiatry at the University of Minnesota, who was not involved in the study.

Dr. Kumra said the results revealed significant differences in the drugs’ side effects that should help doctors and patients choose among them.

“What this is saying is that all treatments work, at least for some people, and have serious risks for others,” he said. “It’s a trial-and-error process” to match people with the right medication.

Dr. Jon McClellan of the University of Washington, a co-author of the new study and of the current guidelines for treating childhood schizophrenia, said in a telephone interview that older schizophrenia drugs should now be considered as an alternative in some cases.

“Some of the children in this study gained 15 pounds or more in eight weeks,” Dr. McClellan said. “That’s as much as adults gain in a year on these medications. Children are especially susceptible to these side effects, and this has broad implications across the board, for the use of these agents to treat any disorder.”

Studies have found that more than 80 percent of prescriptions for atypical antipsychotics for children are to treat something other than schizophrenia, like autism-related aggression, bipolar disorder or attention-deficit problems. Some of these are approved uses; others are not.

The researchers, led by Dr. Linmarie Sikich of the University of North Carolina, recruited 119 young people, ages 8 to 19, who suffer from psychotic symptoms. The children received either Zyprexa, Risperdal or molindone, an older drug used to blunt psychosis. Neither the young patients nor the doctors treating them knew which drug was being taken, but the researchers told the youngsters and their parents that, if the medication was not working out, the family could switch to another one.

After eight weeks, 34 percent of the children taking Zyprexa, 46 percent of those on Risperdal, and 50 percent of those receiving molindone showed significant improvement.
But by that time so many of the patients had stopped taking the drug they were on that it was not clear that those differences were significant. Many had gained a lot of weight: an average of about nine pounds for those in the Risperdal group, and 13 pounds in the Zyprexa group.

Both groups also showed changes in cholesterol and insulin levels that are risk factors for diabetes. Those taking molindone gained less than a pound, on average, and had little metabolic changes.

“I thought the extra weight was putting a lot of pressure on me,” said Brandon Constantineau, 18, a study participant in Wilmington, N.C., who gained 35 pounds while taking Risperdal for several months. “Kids at school were making fun of me, all that. I knew I had to get rid of it. I exercised a lot, but it didn’t happen until I changed drugs.”

Mr. Constantineau said he was now doing well on a medication not offered in the study.

Dr. Sikich, the study’s lead researcher, said, “One implication of this study is that the guidelines for treating schizophrenia need to be revised, so that some of the milder, traditional or older medications are considered first-line treatments in some cases.” She added: “The other significant thing is that none of these medications were as well tolerated as we had hoped. We really need to find better alternatives.”

Spokesmen for Eli Lilly and Janssen said that their drugs were not approved to treat schizophrenia in children and that, given the limited number of options for such patients, there was a need for new therapies.

Jamaison Schuler, a spokesman for Eli Lilly, pointed out that the new study, at eight weeks in length, had not lasted long enough to pick up the most worrisome side effect associated with the older drugs: Parkinson’s-like movement problems, which are often irreversible. Patients in the study taking molindone also took another drug to reduce this risk.

Beginning in the early 1990s, psychiatrists turned to the newer drugs in large part to spare their patients those problems. Several large studies since then have shown that that shift — while perhaps sparing some patients movement problems — has had a cost.

A landmark comparison of older and newer drug in adults with schizophrenia, published in 2005, had findings similar to the new report. Most patients in the earlier study stopped taking the drug they were put on, and some of the medications were associated with rapid weight gain and other problems.

“I think the reason the use of these newer drugs has gone up so fast is that there was this widespread assumption that they were safer and more effective than what we had before,” Dr. McClellan said. “Well, we’re seeing now that that’s not the whole story.”

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New Mexico Sues Maker of Risperdal

Albuquerque Journal
By Scott Sandlin

… According to the lawsuit:

Janssen got FDA approval to market Risperdal oral tablets for the treatment of schizophrenia in 1993 and for variations to treat bipolar disorder in 2003. But the drug has shown a propensity for its users to gain weight, have movement disorders and other health problems, including diabetes.

Since its launch, the maker has “engaged in widespread fraudulent statements and conduct, and pervasive false and misleading marketing, advertising and promotion.” The maker failed to warn and misled physicians, consumers and the state regarding its adverse effects.

The maker actively marketed the drug for uses in several populations where its safety had not been established, such as people with sleep disorders, elderly patients with dementia and patients with depressive or mood disorders.

The alleged scheme was carried out by directly soliciting physicians to prescribe it by giving false information to them and to pharmacists, including the development of deceptive and misleading medical literature and funding of questionable scientific literature.

One marketing plan used company-funded events at which doctors selected, trained and approved by Janssen would falsely oversell Risperdal’s safety and effectiveness, according to the complaint.

The strategy worked, making more than two-thirds of all dollars spent on Risperdal going for nonmedically necessary uses and making the drug the mostly widely used antipsychotic of its type in the world, with sales skyrocketing to $3.5 billion in 2005.

The lawsuit was filed for the Attorney General’s Office in the 1st Judicial District Court in Santa Fe by a Houston civil litigation firm, Bailey Perrin Bailey, which specializes in lawsuits over the new generation of antipsychotic drugs known as atypical antipsychotics. The firm represents other states in lawsuits over Risperdal, including one filed in Pennsylvania state court in February.

The lawsuit is the second time in two years the state has sued a drugmaker raising questions about state obligations under federal Medicaid law, as Janssen attorney Douglas Schneebeck of the Modrall law firm noted in removing the lawsuit to federal court.

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Antipsychotics & Kids: States Are Cracking Down

Pharmalot
By Ed Silverman

Jeffery Thompson, Chief medical officer of Washington state’s Medicaid program

Jeffery Thompson, Chief medical officer of Washington state’s Medicaid program

Over the past few years, atypical antipsychotics have been eating up a growing portion of state Medicaid budgets, from 4.5 percent in Arizona to 13.3 percent in Massachusetts. Several states, in fact, have sued one or more drugmakers for allegedly withholding side effect info or improperly promoting their meds, prompting Medicaid overpayments. However, the fastest growth is prescribing for children, sometimes for uses not approved by the FDA, such as ADHD. Jeffery Thompson, the chief medical officer of Washington state’s Medicaid program, is heading a consortion of 15 state Medical medical directors, who plan to issue a report early next year that examines prescribing trends, dosing, and demographics, among other things. We spoke about the issue…

Pharmalot: So why are you looking into this? Why is this an issue?

Thompson: The number one drug class in expenditures is atypical anti-pyschotics in almost every state. And the fastest-growing utilization is for both on and off label use in children. And as part of our jobs, we have a special relationship with foster care children, for instance, which means we should pay particular attention as prescribers use these to treat the children We also know there is wide variation within states and across states among utilization in kids, and we believe we should understand why that is.

Pharmalot: What, specifically, is your group examining?

Thompson: There’s a rapidly evolving constellation of diagnoses these drugs are being used for that are constantly evolving, with and without evidence or FDA labeling. And when there’s both limited evidence and labeling, it’s something we need to look at. For example, at what age can you diagnose somebody with bipolar disorder? Is it three years old? Seven years old? 12 years old? 18? There’s some evidence that it’s happening at all of those ages. But when is it appropriate to add an antipsychotic in addtion to a stimulant for treating ADHD in a child? And with off-label use, should there be an upper limit of dose by certain ages? Another question is when is it appropriate, or not safe, to combine multiple drugs when treating a child? We have some children who are on one, two, three or four at any one time. We see children being prescribed three to five times the FDA-approved adult dosages. So we’re looking at whether the trend indicates what I refer to as too young, too much or too many.

Pharmalot: How did the effort get started? And why aren’t more states involved?

Thompson: Last june, Washington state Medicaid convened a meeting of Medicaid medical directors, which is a nationwide group, to discuss integration of medical and mental health. And I posed a project where we would all look at utilization of kids getting antipsychotics. So we’re now actively pulling data. There directors representing.25 to 30 states at last year’s meeting and 42 states are in the network. Some states are examining data on their own, but all can share the results.

Pharmalot: Beyond compiling numbers, what do you hope to accomplish?

Thompson: We want to define our best practices and improve antipsychotic prescrbiing to children. In Texas, they’re working with their psychiatric community on algorithms, for instance. In many states, Eli Lilly works with state programs to provide report cards. Other states have specific guidelines. But we need to share what is being done in order to develop what can be considered a best practice, and then look at any additional steps, such as further clarification of state programs or gathering other data from state databases based on our findings. And we eventually hope to publish a paper.

Pharmalot: With so many states suing these drugmakers and the point made about budget dollars being spent, it sounds like this just as much about saving money, yes?

Thompson: I would say this project is not designed to save money. It’s designed to improve the health and safety of our children. If you look at our data dictionary, cost has a deminimus amount of activity in this project. It’s actually one very small component of the data we’re looking at. Most data we’re pulling relates to safety. Again, our primary hope is to improve health and safety of prescribing the drugs to children and reduce unneeded variation in care.

Pharmalot: To what extent is the pharmaceutical industry involved?

Thompson: Well, I mentioned earlier that some states have arrangements with Lilly to monitor prescribing trends. But the effort is independent of the industry. The Agency for Health Care Research and Quality is underwriting the project. We have the sanction and approval of state medicaid directors and state mental health directors, and these groups are actually doing the work, along with researchers at Rutgers University. I know my own state, the state of Washington, has invited pharmaceutical companies to meet with our mental health network group at all times to ensure there is appropriate use of medications. Apart from that, any findings from the study will be shared with the industry.

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Florida Legislator Questions Antipsychotic Spending

Pharmalot
By Ed Silverman

Earlier this summer, the state’s Agency for Health Care Administration reviewed new guidelines on paying for antipsychotic drugs for children. This came after newspaper stories detailed that the number of kids in the program prescribed the meds had nearly doubled between 2000 and 2006. however, the most common primary diagnosis was ADHD, an ailment not approved for using the meds.

The agency proposed rule changes to permit Medicaid reimbursement under one of two circumstances: if an antipsychotic has an FDA-approved use or is listed in an official compendium or – and this is the new twist – if prior authorization is granted. Both moves would continue to make it possible for very young children to receive antipsychotics. Only Johnson & Johnson’s Risperdal is approved for children as young as 5, and only for treating irritability associated with autism.

Nonetheless, a Florida legislator has since questioned the rationale for permitting Medicaid to pay for antipsychotic prescribing for unapproved uses, even though doctors are allowed to prescribe off-label uses. Twice, Ed Hooper has written AHCA secretary Holly Benson to pursue the state spending, although an AHCA spokeswoman tells us they have not yet provided a response. Here are his letters: http://tinyurl.com/5ck7lx

Legislators in other states, such as New Jersey and New Hampshire, have separately made similar inquiries to their own state officials about increased Medicaid spending on antipsychotics, and a group of 15 state Medicaid medical directors is preparing a report for release by January (more on this tomorrow).

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Half of nursing home residents wrongly drugged

The Daily Telegraph
London, England
By Kate Devlin – Medical Correspondent

Experts who looked at 22 nursing homes found 51 per cent of residents were being inappropriately given drugs, including anti-psychotics, antidepressants and painkillers.

More than 420,000 people live in care and nursing homes in Britain, of which around 405,000 are elderly.

Previous estimates have suggested that 100,000 residents, suffering from dementia, were being drugged unnecessarily every year.

However, if the results of this study are replicated across the country, it suggests that around 200,000 patients are being given inappropriate medication in homes.

Paul Burstow, the Liberal Democrat MP, said: “This adds to the growing evidence that inappropriate medicating in care homes is much more routine in practice than we would like to believe.

“And when it comes to the prescribing of anti-psychotics, these drugs are actually killing people. The Government must come up with concrete proposals to crack down on this problem.” Mr Burstow has previously called for GPs who overprescribe to patients in homes to face prosecution.

The use of anti-psychotics has become increasingly controversial in recent years after they were linked to strokes. A report released last year suggested that the drugs could be responsible for more than 23,000 deaths in care homes every year.

Lizzie McLennan, from Help the Aged, said that “too many” elderly people were being drugged in care homes.

She called for GPs to be forced to make regular visits to care homes for which they prescribe and for routine reviews of residents’ medication.

The nursing homes study shows that when pharmacists reviewed the medication residents had been prescribed 171 out of 334 were receiving drugs that they did not need.

The findings, by researchers at Queen’s University in Belfast and Brown University in Rhode Island, were presented at the British Pharmaceutical Conference in Manchester.

Another study also presented at the conference shows that staff at nursing homes believed that the culture in a home could lead to over prescribing and patients receiving powerful drugs they did not need “to make life easier”.

The Government has ordered a review into inappropriate prescribing in care homes, which is due to report later in the autumn.

Critics say that problems can arise because some GPs visit care homes only rarely and rely on issuing repeat prescriptions from one year to the next, and because of the commercial relationship that can exist between GPs and homes.

Anti-psychotic drugs are not licensed to treat dementia but are commonly prescribed to control agitation, sleep disturbance and aggression in sufferers in care homes, previous studies have shown.

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AstraZeneca’s Seroquel on FDA warning list

The News Journal
By ANDREW EDER

AstraZeneca’s antipsychotic drug Seroquel is one of 20 medications being investigated for potential safety problems, federal regulators said Friday.

The list of drugs posted by the U.S. Food and Drug Administration under the requirements of a new law offered little information except for the potential risks the agency was examining.

Seroquel was being looked at for “overdose due to sample pack labeling confusion,” presumably referring to label information on the free drug samples AstraZeneca distributes to doctors and hospitals. Neither the FDA nor the drug maker would elaborate on the potential risk.

“We know that FDA has received reports regarding the label on sample packs for Seroquel, and we are working closely with the FDA to determine the nature of these reports,” said AstraZeneca spokeswoman Abby Baron. An FDA spokesman did not respond to questions on the Seroquel reports.

The FDA compiled its list from “adverse event” reports it receives from drug makers, doctors and patients. For a medication to be listed, the FDA said, an agency reviewer has determined that the drug merits a closer look because of the number or seriousness of the complaints…

FDA officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation…

The FDA’s list received a mixed reaction from some consumer advocates who said more information was needed about the potential risks.

“It’s a good thing to get started but it needs to have much more detail if it’s to have significant safety value,” said Thomas J. Moore, a senior scientist with the Institute for Safe Medication Practices.

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