Psychotic Reaction: Treating ADHD In Maine

By Ed Silverman

Earlier this week, the FDA advisory committee slammed the rising use of antipsychotics in youngsters, particularly to treat attention deficit disorders. The meds, you see, were approved by the agency for schiozphrenia or bipolar disorder – and only recently for youngsters, in some cases (back story).

The trend, however, to prescribe these meds for teenagers and children has actually been widespread, with Medicaid programs in several states reporting rising expenditures for antipsychotics to treat ADD or ADHD. A report issued last year by the University of South Florida found that among children 5 years or younger, 53.8 percent were prescribed antipsychotics for a diagnosis of ADHD. The figure was 48.8 percent for children between 6 and 12 years old (see page 22).

The issue is gaining attention because most of the meds can cause weight gain and metabolic disorders, and the FDA committee complained current warnings are insufficient. The meds include Johnson & Johnson’s Risperdal, Lilly’s Zyprexa, AstraZeneca’s Seroquel, Bristol-Myers Squibb’s Abilify and Pfizer’s Geodon. As we have written previously, a consortium of state Medicaid directors is evaluating the use of the drugs in children to ensure they are being properly prescribed (take a look).

And now we have another example. In Maine, spending by the state Medicaid program on each of the five widely prescribed antipsychotics has been rising for children 18 years and younger since 2000, except for Zyprexa. At the same time, ADHD has been the number one diagnosis among the same population each year, except for last year, when prolonged post-traumatic stress disorder was more widely diagnosed. See the chart. The data is courtesy of the Office of Maine Care Services.

FDA Panel to Review Zyprexa Side Effects for Children

November 18th, 2008

At a meeting of the FDA’s Pediatric Advisory Committee today [11/18/08], potential label changes will be considered for Eli Lilly’s antipsychotic drug Zyprexa. The Committee will evaluate whether new warnings are necessary about the risk of potential Zyprexa side effects for children, such as severe weight gain, hyperglycemia or other metabolic effects.Zyprexa (olanzapine), is an atypical antipsychotic medication that has been used by more than 26 million people worldwide.

It is manufactured and marketed by Eli Lilly & Co., and was first approved in the United States in 1996 for treatment of schizophrenia and bipolar disorder in adults. It has also been widely prescribed off-label for other unapproved uses, such as treatment of dementia and mild forms of bipolar disorder.

Although Zyprexa is only approved by the FDA for use by those 18 years or older, it is commonly prescribed off-label to children, and Lilly has been seeking approval to market the drug for children between 13 and 17 years of age.

In documents released in advance of the advisory meeting today, FDA staffers suggested that new language should be considered to specifically warn about the potential side effects of Zyprexa for children. This could include information about the risk of weight gain and other metabolic changes that are already noted on the label for adults.

As a result of Lilly’s failure to adequately warn about these side effects in the past, the drug maker has already paid about $1.2 billion to settle over 30,000 Zyprexa lawsuits filed by users who suffered diabetes, hyperglycemia, pancreatitis and other injuries.

Lilly has also paid millions to settle claims over their marketing practices, which included claims that they marketed the drug for unapproved uses and downplayed the risk of Zyprexa side effects.

According to the New York Times, Eli Lilly is also expected to pay at least another $1 billion in restitution and fines to resolve federal criminal investigations related to their marketing of Zyprexa.

At the Pediatric Advisory Committee meeting on November 18, 2008, independent panel of experts will also consider potential side effects of Lamisil for children. According to the same FDA staff review documents, Novartis’ antifungal drug has been associated with a risk of psychiatric side effects in children, including cases of depression, suicidal thoughts and self-harm.

The Best Pharmaceuticals for Children Act of 2002 requires drug reviews for all drugs recently tested in children. The FDA advisory panel consists of outside experts who will discuss the reports and make recommendations to the FDA about adding warnings to the drug labels about potential side effects in children.

Use of Antipsychotics in Children Is Criticized

From The New York Times

November 18, 2008
Powerful antipsychotic medicines are being used far too cavalierly in children, and federal drug regulators must do more to warn doctors of their substantial risks, a panel of federal drug experts said Tuesday.
More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular medicines known as atypical antipsychotics. Of those patients, 240,000 were 12 or younger, according to data presented to the committee. In many cases, the drug was prescribed to treat attention deficit disorders.But Risperdal is not approved for attention deficit problems, and its risks — which include substantial weight gain, metabolic disorders and muscular tics that can be permanent — are too profound to justify its use in treating such disorders, panel members said.

Go here to read the full article:

Radio Host Has Drug Company Ties

from The New York Times
November 22, 2008

An influential psychiatrist who was the host of the popular NPR program “The Infinite Mind” earned at least $1.3 million from 2000 to 2007 giving marketing lectures for drugmakers, income not mentioned on the program.

The psychiatrist and radio host, Dr. Frederick K. Goodwin, is the latest in a series of doctors and researchers whose ties to drugmakers have been uncovered by Senator Charles E. Grassley, Republican of Iowa. Dr. Goodwin, a former director of the National Institute of Mental Health, is the first news media figure to be investigated.

Margaret Low Smith, vice president of National Public Radio, said NPR would remove “The Infinite Mind” from its satellite radio service next week, the earliest date possible. Ms. Smith said that had NPR been aware of Dr. Goodwin’s financial interests, it would not have broadcast the program.



          Uniting together in a heated discussion on the Missouri vote, the Citizen’s Commission on Human Rights denounced “Putting Kids First” (Proposition 1) as an utter deception – a campaign aimed only at making money out of drugging children.  Infuriated that Proposition 1 was voted into existence, CCHR initiated a plan the day after elections during a seminar on human rights to make known how it was pushed by mental health agencies into existence.

          According to Proposition 1, a fund will be generated whereby a sales tax increase of 1 cent on every $4 of sales in St. Louis County will be paid to non-profit agencies that provide mental health and substance abuse services to children aged 19 and younger.  However, CCHR reports that much of the money will be used to hook children on addictive and abusive psychiatric drugs.

          The Citizen’s Commission on Human Rights, a psychiatric watchdog and human rights advocacy group, announced that the financial profit made from psychiatric drugs is now a $330 billion a year industry, without producing one single cure.

          Psychiatrists claim that Proposition 1 is needed because they are not getting enough funding for mental health and substance-abuse services for youth.  Yet, the budget for the Missouri Department of Mental Health in the last six years alone has jumped 170%, to a figure of more than $1.1 billion. “And there has been no result!” exclaimed Moritz Farbstein of CCHR in St. Louis.

          Since 2003, the Drug Enforcement Agency has reported more than 60 international drug regulatory warnings about the risks inherent in taking psychotropic drugs.  Such risks include antidepressants being capable of causing suicide and hostility and stimulants prescribed to children may put them at risk of heart problems, stroke and even death.

          For decades, CCHR has fought to expose the dangers and fraud of the psycho-pharmaceutical industry despite the objections of vested interests that profit from keeping the truth concealed.  For more information on the Citizen’s Commission on Human Rights, go to