Psychotic Reaction: Treating ADHD In Maine

By Ed Silverman
chart

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.

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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.

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Use of Antipsychotics in Children Is Criticized

From The New York Times

November 18, 2008
By GARDINER HARRIS
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:

http://www.nytimes.com/2008/11/19/health/policy/19fda.html?ei=5070&emc=eta1

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Radio Host Has Drug Company Ties

from The New York Times
November 22, 2008
By GARDINER HARRIS

http://www.nytimes.com/2008/11/22/health/22radio.html?emc=eta1

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.

CLICK HERE TO READ THE FULL ARTICLE

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“PUTTING KIDS FIRST”: NOTHING BUT A HOAX

          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 www.cchrstl.org.

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psychiatric shenanigans – no joke

Rajiv Tandon is known as the top psychiatrist in the State of Florida.
He is the Chief of Psychiatry over Florida’s Department of Children and Families.

This 2-1/2 minute video

http://www.youtube.com/watch?v=WCM3klGpQEk

shows Tandon joking about psychiatrists. It’s a funny joke, and not far from the truth.

Tandon’s activities as a Florida government official  include the promotion of antipsychotic drugs which is costing Florida millions upon millions of Medicaid dollars. His activities  were written up in the St. Petersburg Times.

See here: http://tampabay.com/news/health/article454391.ece

According to the below documentation Tandon has been working as a Florida government official while concurrently working for drug companies.


Top Florida Psychiatrist – Rajiv Tandon  - financial connections to antipsychotic drug makers:May 1, 2004Starting working at Florida’s Department of Children and Families while “on loan” from Florida State University

June 1, 2004
http://web.archive.org/web/20060331190500/http://medschool.slu.edu/psych/index.phtml?page=June2004Rounds&cat=calander
Dr. Tandon is on the Speakers Bureau for Astra Zeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, and Pfizer. 

 

July 13, 2004
http://www.psipanama.org/optimizing.pdf
Rajiv Tandon, MD, Chief of Psychiatry, Florida Department of Children and Families, Tallahassee
Dr. Tandon is a consultant and a member the speakers/advisory boards for AstraZeneca, Abbott, Bristol Myers Squibb, Eli Lilly, Janssen and Pfizer
  

December 2004
http://www.jhasim.com/template.cfm?TEMPLATE=include_programinfo.cfm&ID=128&ZoneID=29&TYPE=faculty
Rajiv Tandon, MD, Chief of Psychiatry, Florida Department of Children and Families, Tallahassee, Florida
Dr Tandon reports serving as a consultant to AstraZeneca LP, Bristol-Myers Squibb Company, Eli Lilly and Company, Janssen Pharmaceutica, and Pfizer Inc.

2005 

http://www.psychsearch.net/apa2005.pdf
AstraZeneca Pharmaceuticals1,4; Bristol-Myers Squibb1,4; Eli Lilly and Company1,4; Pfizer Inc.1,4; Janssen Pharmaceutica Products, LP1,4
(1 = consultant or advisory board; 4 =  speakers’ bureau)

2005
http://www.dowdencme.com/Landing.asp?TestID=36
Rajiv Tandon, MD, reports that he serves as a consultant to and on the speakers’ bureaus of AstraZeneca Pharmaceuticals, Bristol-Myers Squibb Co, Eli Lilly and Co, Janssen Pharmaceutica, and Pfizer Inc.  

November 22, 2006
http://www.psychiatrictimes.com/psychiatryNews/showArticle.jhtml?articleID=195900165&cid=BreakingNews
Rajiv Tandon, M.D., of the University of Florida in Tallahassee gave a presentation.  The symposium was sponsored by Janssen pharmaceuticals. Both Dr Tandon and Dr. Feldman are members of the speakers bureau for Janssen, the sponsor of the symposium, and have financial relationships with Pfizer, AstraZeneca, and Bristol-Meyers Squibb as well.

2007

http://www.psychsearch.net/apa2007.pdf
AstraZeneca Pharmaceuticals LP4; Bristol-Myers Squibb Company4; Eli Lilly and Company4;Janssen Pharmaceutica Products, LP 4; National Institute of Mental Health 4; Otsuka America Pharmaceutical, Inc4 ; Pfizer Inc.4 

(1 = consultant or advisory board; 4 =  speakers’ bureau)

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Psychiatrist Accused of $2.8 Million Payola From Pharmaceutical Company

The cozy relationship between academic research and the pharmaceutical industry was revealed as a prominent Emory University psychiatrist failed to report $2.8 million he received in consulting fees from GlaxoSmithKline. The allegations against Charles B. Nemeroff, MD, were announced in the probe headed by Sen. Charles Grassley (R-Iowa), who is promoting a bill called the “Physician Payment Sunshine Act” that would require pharmaceutical companies and medical devise manufacturers to report payments over $500 that they make to physicians.He allegedly repeatedly underreported the amount of consulting money he was paid, year after year.

Nemeroff is the 6th physician accused since the investigation began earlier this year. These psychiatrists are from the top research institutions in the country. They are leaders in the profession and one was the president-elect for the American Psychiatric Association. The physicians consult with 20 or more drug and devise companies at one time with lucrative arrangements for speaking, conducting symposiums, and writing about the safety and efficacy of drugs.

It is critical that academic research and influential professors that do the research be independent of drug company influence and money. Several studies have shown that people who receive money from drug companies are more likely to report positive results from the drug.

Dr. Nemeroff stepped down from his role as Emory Department Chair of Psychiatry October 4 pending resolution of the issue, and as of October 14 Nemeroff stepped down from university research projects funded by the National Institutes of Health, as the federal agency cracks down on the school’s handling of potential conflicts of interest. The NIH has frozen funds for a $9.3 million project on depression led by Nemeroff.
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33 States to Get $62 Million in Zyprexa Case Settlement

Eli Lilly has agreed to pay $62 million to 33 states to settle claims that it improperly marketed Zyprexa, its top-selling drug, to patients who did not have schizophrenia or bipolar disorder, its only approved uses.

Illinois will receive nearly $3.6 million in settlement funds from the company. Missouri will receive $1.5 million.

Lilly also agreed to several mandates that will last until 2014, well beyond the expiration of Zyprexa’s patent in 2011. The company agreed to avoid making false, misleading or deceptive claims about the drug and not to promote it outside FDA-approved uses.

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MENTAL HEALTH DAY VIGIL FOR THE THOUSANDS OF CHILDREN KILLED BY PSYCHIATRIC DRUGS

Calls to Prohibit Mental Health Screening in Schools

On the eve of Mental Health Day (October 10, 2008), a candlelight vigil was held in the University City Loop in St. Louis in memory of the thousands of children that have died from psychiatric drugs. An estimated 1,340 under-18-year-olds die each year in the United States from psychiatric drug use. Large photos of children at the Vigil were testimony to the many tragic deaths. In recent years, the Food and Drug Administration has increased its warnings about these drugs causing psychosis, suicide, stroke, heart attacks, life threatening diabetes and death.

The Citizens Commission on Human Rights, a psychiatric watchdog and human rights advocacy group that organized the vigil, says that mental health screening of students has exacerbated the problem, often wrongly identifying children as “mentally ill,” resulting in their being prescribed these drugs. Currently, there is a federal initiative to screen all 52 million American schoolchildren for mental disorders that could dramatically increase the number of children placed at risk with psychotropics.

People viewing the Vigil signed a Proclamation that calls on the State Department of Education to jettison psychological and psychiatric screening from their schools and for the state government to reallocate funding for such screening to educational, non-drug programs and additional teachers or tutors.

One screening program, TeenScreen, has an admitted 84 percent failure rate by wrongly identifying children as depressed or potentially suicidal that can lead to their being prescribed antidepressants that can induce suicidal thoughts and actions.
CCHR spokesperson Teresa Hassler said, “All the symptoms listed in the ‘Screen Information Form’ are extracted from those listed in the American Psychiatric Association’s (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM), a manual criticized for its lack of reliability and conflict of interest with the pharmaceutical industry.”

A 2006 study published in Psychotherapy and Psychosomatics determined that psychiatric drug makers funded 100% of the DSM Task Force members that decided what “mood” and “psychotic” disorders were included in the DSM. This year, the Senate Select Finance Committee called on the APA to hand over its financial records relating to pharmaceutical companies. At least 30% of the APA’s income derives from drug makers.

Ms. Hassler said, “Around the world we are holding vigils as a reminder and warning that children are dying from psychotropic drugs that are often pushed through schools. The heavy reliance upon screening here is likely a major factor.” According to a study published in the September issue of the British-based journal BioMed Central, youngsters in the U.S. are three times likelier to be prescribed antidepressants and stimulants and twice as likely to be prescribed antipsychotic drugs, than counterparts in European countries such as Germany and the Netherlands.

Between 1995 and 2002, prescriptions of antipsychotics for children aged 2 to 18 leaped fivefold—from just under half a million to about 2.5 million. In 2003, the FDA warned that antipsychotic drugs could cause diabetes and blood-sugar abnormalities, after 45 child deaths had been reported.

Last year, The New York Times also pointed to the fact that psychiatrists top the list in drug maker gifts that influences drug prescription trends. In Minnesota it was determined that psychiatrists who received at least $5,000 from makers of newer-generation antipsychotic drugs wrote, on average, three times as many prescriptions to children for these than psychiatrist who received less money or none.

In Vermont, drug-company payments to psychiatrists more than doubled from $20,835 in 2005 to an average of $45,692 in 2006. State Attorney General Bill Sorrell stated, “It is particularly troubling that the industry is paying large sums of money to influence prescribing practices involving psychiatric drugs.”

Unlike for most medical conditions, psychiatrists admit they do not know the cause of or cure for any mental disorder for which they prescribe mind-altering drugs. Dr. Thomas Szasz, professor of psychiatry emeritus at the State University of New York, Health Science Center in Syracuse, New York, says, “There is no blood or other biological test to ascertain the presence or absence of a mental illness, as there is for most bodily diseases.”

Proponents of TeenScreen claim that screening can prevent suicides. However, Robert Whitaker, science writer and author of Mad in America, says, “They’re pulling numbers out of thin air—falsely presuming that this crisis is about lack of access to drugs and calling for government to provide more and more of what many of us believe is the wrong kind of treatment.”

A 2005 study by Dr. David Healy and Graham Aldred from the North Wales Department of Psychological Medicine, Cardiff University, Wales, reported that the studies of the newer antidepressants (Prozac, Zoloft, Effexor etc.) show that they increase the risk of suicide. The FDA has a “black box” on antidepressant packaging warning that the drugs can cause suicidal thoughts and actions in those 24 years of age and under.

Dr. Julian Whitaker, director of the renowned Whitaker Wellness Center in California, advises parents: “First of all, refuse to sign those [screening] consent forms when they come home from your child’s school—if they can’t test them, they can’t drug them.”

CCHR was established in 1969 by the Church of Scientology and the eminent Dr. Thomas Szasz, Professor of Psychiatry Emeritus, State University of New York Health Science Center in Syracuse, New York. It has helped obtain legislation protecting children from potentially lethal psychiatric drugs for 40 years.

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Drug Regulatory Agency Warnings on psychiatric Drugs

The following is a small sample of drug regulatory agency warnings about psychiatric drug adverse reactions. Many consumers are unaware of these side effects or that they can report such effects to the federal drug regulatory agency.

 

2004:

 

March: The U.S. Food and Drug Administration (FDA) warned that Prozac-like antidepressants (SSRIs) could cause: “Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia [severe restlessness that can lead to mania/psychosis], hypomania [abnormal excitement] and mania [exalted feelings, delusions of grandeur].”

 

June:  The FDA ordered that the packaging for the stimulant Adderall include a warning about sudden cardiovascular deaths, especially in children with underlying heart disease.

 

September: The FDA warned that diabetes is a risk for those taking the latest antipsychotic drugs, including Zyprexa.

 

October:  The FDA ordered its strongest “black box” warning to antidepressant packaging, alerting that the drugs could cause suicidal thoughts and actions in children and teenagers.

 

December:  The FDA required that packaging for the “ADHD” drug Strattera carry a new warning advising, “Severe liver damage progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients.”

 

2005:

 

April: The FDA required a “boxed warning” for packaging of antipsychotic drugs warning of the risk of death in elderly patients with dementia taking them.

 

June: The FDA announced its intention to make labeling changes for Concerta and other stimulants to include, “psychiatric events such as visual hallucinations, suicidal ideation [ideas], psychotic behavior, as well as aggression or violent behavior.”

 

June   The FDA warned that the antidepressant Cymbalta could increase suicidal thinking or behavior in pediatric patients taking the drugs. In October, it also ordered an additional warning of potential liver damage.

 

August: The Australian TGA reported that SSRI antidepressants could cause “new onset of suicidality” in adults and also agitation, nervousness and anxiety. Similar symptoms could occur during withdrawal.

 

August: The European Medicines Agency’s Committee for Medicinal Products issued its strongest warning against pediatric use of antidepressants, stating they could cause suicide attempts and thoughts, aggression, hostility and oppositional behavior and anger.

 

September:  The Agenzia Italiana del Farmaco (Italian drug regulatory agency) ordered a warning label for older type antidepressants advising against use in under 18 year olds; the drugs were also associated with heart attacks in people of any age.

 

October: The FDA withdrew the stimulant Cylert from the market because of its “overall risk of liver toxicity” and liver failure.

 

November:  The FDA approved updated labeling for the antidepressant Effexor ER (extended release), to note it could cause homicidal ideation.

 

December:  Health Canada warned that pregnant women taking Paxil placed their newborn at risk of birth defects.

 

2006:

 

 

February:  The British Medicine and Healthcare Products Regulatory Agency reported the antidepressant Strattera (also used for “ADHD”) was associated with seizures and a potentially dangerous lengthening of time between heartbeats.

 

May:  Health Canada issued new warnings of rare heart risks for all stimulants, such as Ritalin and Adderall, including the risk of sudden death. In August, the FDA ordered a similar warning be added to stimulant drug packaging.

 

July: The FDA warned of the risk of a fatal lung condition in newborns whose mothers took SSRIs during pregnancy.

 

2007:

 

March:  New Zealand urged health professionals to monitor patients on the antipsychotic drug Clozapine after a review found five people had died.

 

May 2: The FDA extended the age group for the black box warning about antidepressants inducing suicide from 18 to 24.

 

June:  The Australian TGA reported a range of cardiac disorders (potentially fatal inflammation of the heart muscle) associated with the use of the antipsychotic, Clozapine.

 

September: The FDA reported a warning was added to the antipsychotic Haldol (haloperidol) about the potential risk of death and dangerous heart conditions observed in some patients.

 

2008:

 

June: The FDA issued a warning that antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. It specified that antipsychotics were not indicated for the treatment of this condition and could increase risk of death in some elderly people.

 

 

You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


No one should stop taking any psychiatric drug without the advice and assistance of a competent, non-psychiatric medical doctor.

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