Archive for April, 2008

Heart Risk In Kids from psychiatric Stimulant Drugs

Monday, April 28th, 2008

Stimulant Heart Risk In Kids Prompts Calls For Registry For All Child Deaths Linked To Psychotropic Drugs
1,300 Child & Adolescent Deaths Per Year Needs Urgent Federal Response
 
The American Heart Association this week recommended that doctors conduct a physical exam and an electrocardiogram before prescribing children stimulant drugs like Ritalin that could cause cardiac arrest. It also recommended a “Sudden Cardiac Death/Arrest registry in children” be established. But the Citizens Commission on Human Rights (CCHR), a group that has been investigating and exposing the potentially deadly effects of stimulants and other psychiatric drugs for nearly 40 years, says a federal registry is needed for all pediatric deaths linked to prescribed psychotropic drug use.
 
The Food and Drug Administration found 19 sudden deaths in children on stimulant drugs while another 24 died of heart-related problems over a period of five years. However, doctors only report 1 to 10 percent of adverse reactions to the FDA. In analyzing the FDA’s Adverse Drug Reaction database for all psychiatric drugs (stimulants, antipsychotics, antidepressants, sedatives), CCHR estimates that the combined total of child deaths each year is more than 1,300. Stimulants are prescribed for “Attention Deficit Hyperactivity Disorder,” which many medical experts say is not a legitimate disease but an excuse to chemically control boisterous childhood behavior. There are no blood or urine tests, brain scans or X-rays that can diagnose ADHD.  
 
CCHR President Ms. Jan Eastgate said, “The pharmaceutical-psychiatric conflicts of interests that make stimulant prescriptions and sales a $3 billion a year industry in the US should be overridden for the safety of children. All psychiatric drugs—the sales of which have soared to $28 billion a year—have serious risks. A federal registry should record the death of every child and adolescent who dies from physical complications—heart attacks, strokes, sudden death, respiratory failure and suicide—while taking a prescribed psychiatric drug. Much stronger drug information warnings are also needed if we are ever going to prevent future deaths.”
 
Eastgate said the first Ritalin death reported to CCHR was in 1986 when 13-year-old Samuel Grossman from Travis County, Texas, died from a heart attack while taking the drug. An autopsy found an enlarged heart caused by long-term stimulant use. At the time, Guenter Lewandowski, a spokesman for Ritalin’s manufacturer, ignored the evidence and stated, “We see no connection between Ritalin intake and the mention of deaths.”
 
In March 2000, Matthew Smith, 14, of Michigan, was skateboarding when he suffered a heart attack and died. He’d been taking Ritalin since he was 7 years old. The coroner determined that Matthew’s heart showed clear signs of the small blood vessel damage that stimulant drugs and amphetamines cause. Then, psychiatrists told the media that the death was unrelated to Ritalin.
 
It was another six years before parents were told the truth. Health Canada acted first when in May 2006 it issued a public advisory caution that stimulant drugs could increase heart rate and blood pressure that could result in “cardiac arrests, strokes or sudden deaths.” The FDA limped behind for three months, waiting until August before issuing a similar warning.
 
Eastgate says that drugging children, even infants as young as one, has become psychiatry’s cash cow and is placing more and more children at risk. Increasing prescription rates should be a warning bell, she said, for federal action and a registry to monitor deaths related to psychiatric drugs. IMS Health found that between 1995 and 1999 stimulant drug use rose 23 percent; the use of Prozac-like drugs for the 7-12 age group was up 151 percent; for kids 6 and under it soared 580 percent. For children under 18, the use of mood stabilizers other than lithium increased 4,000 percent and the use of new antipsychotic drugs rose nearly 300 percent. From 2001 to 2005, the use of antipsychotic drugs in children and teens grew another 73 percent and today, 2.5 million American children are prescribed the drugs that can cause life-threatening diabetes, while 1.5 million children are prescribed antidepressants that can drive them to suicide.
 
“Sudden death and cardiac arrest due to stimulants are just the tip of the iceberg. We need more effective monitoring of psychotropic drug-related deaths if we are going to save children’s lives,” Eastgate said.
 
CCHR was established in 1969 by the Church of Scientology and eminent New York psychiatrist Thomas Szasz. The author of more than 30 books on psychiatry, Dr. Szasz says there are “catastrophic consequences of child psychiatry, such as the psychopathologizing of child misbehavior and the mass poisoning of ‘hyperactive’ children with Ritalin and other neuroleptic drugs.”

The FDA Issues New Rules on Drug Marketing

Sunday, April 6th, 2008
Your Comments are Needed Now!

 

      The FDA recently announced new rules on how drug companies can promote drugs to your doctor for purposes other than what they were approved for. You can probably think of your own examples, but what if your doctor was handed some new study showing that antidepressants were just great for treating the common cold. While this example is admittedly farfetched, it isn’t out of the question. This practice, known as off-label marketing, has been prohibited in many cases and for good reason. Off-label marketing means that a company is promoting a drug for a different use or for a different population than it was intended for. There could be all sorts of unknown risks. 

     While the use of drugs for unapproved purposes is certainly nothing new, allowing such marketing with little or no oversight is a move that puts us all at risk. Luckily, these rules won’t go into effect immediately and are currently open for public comment. So, the solution is simple: Comment! In fact, don’t just tell the agency what you think, send a copy of your comment to your Congressmen too.

You can read the proposed rule here:

www.fda.gov/oc/op/goodreprint.html.

You can submit your comment here:

Docket Number FDA-2008-D-0053

To find your federal legislators, go to www.congress.org and enter your zip code.

Here are a few points that might help you formulate your comments:

     While the FDA wants to protect the off-label marketing of drugs, states and other federal agencies have gone after numerous drug companies accused of off-label marketing schemes.  Here are a few examples:
 

  • 2003, Pfizer settled with the US Department of Justice for $430 million related to its marketing of the anti-seizure drug Neurontin.
  • 2006, the Texas Attorney General’s office sued Janssen Pharmaceutical over allegations of illegal marketing practices related to the antipsychotic drug Risperdal.
  • 2008, drug maker Eli Lilly is reportedly in settlement negotiations with the US Department of Justice over its marketing of the antipsychotic drug Zyprexa.  According to a recent article in the New York Times, Lilly could end up paying as much as $1 billion.
  • Over 10 states have sued, accusing drug makers of off-label marketing.

 

     This proposed rule change puts patients at risk and violates even the most basic concept of informed consent. Does the FDA want you to have the benefit of the latest greatest wonder drugs? Or is it really about protecting an industry? The FDA’s rush to bring new drugs to the market has not resulted in better health for Americans:
 

  • In 2004, the FDA added black box warnings to antidepressant drugs used in children.  Reported cases of suicide and suicidal thoughts as well as hostility and homicidal behavior had existed for over a decade before the FDA finally took a serious look at the problem.
  • In 2006, the FDA finally warned about aggression, heart complications and psychotic behavior associated with the drugs used to treat Attention Deficit Hyperactivity Disorder.  This agency had been aware of potential heart risks and psychotic behavior associated with stimulant use for decades.
  • The FDA has repeatedly come under fire for failing to adequately ensure drug safety.  Most recently, the FDA admitted it had never inspected a Chinese manufacturing plant that could be the source of a drug ingredient suspected of causing over 350 allergic reactions.
  • The FDA does not have an accurate and dependable system of capturing adverse reactions to drugs. It is estimated that the FDA’s adverse event reporting system (MedWatch) only captures between 1% and 10% of adverse events.

 

     Encouraging drug companies to expand their off-label marketing efforts without rigorous safety testing could expose patients to even greater dangers.

     Take the time to submit your comments today. If you need more information a simple internet search on the FDA and drug safety or off-label marketing should be able to provide more than enough information. You can also read various CCHR publications on the dangers of psychiatric drugs at http://www.cchr.org/psychiatric_drugs/.

How the Legal System Can Help Create a Recovery Culture in Mental Health Systems

Sunday, April 6th, 2008

Jim Gottstein is a lawyer in Alaska and is the founder of the organization PsychRights,  the Law Project for Psychiatric Rights (http://psychrights.org/) which has been around about 25 years, working to bring the mental illness system around to a culture of recovery.

He had a successful verdict for a patient in the summer of 2006, in which the patient’s rights to refuse forced drugging were upheld.

He brought to our attention a paper that he wrote and presented at a seminar in 2005 (“How the Legal System Can Help Create a Recovery Culture in Mental Health Systems”). We are presenting it to you as it contains much useful information on what is required to successfully handle involuntary commitment hearings. Download and read the paper here.

While involuntary commitment laws enrich the psychiatric industry, they not only deprive individuals of their freedom of choice, but milk millions of health insurance dollars annually from private, state, national and military health plans. And while psychiatrists and psychiatric hospitals are today being investigated nationally and in state hearings for insurance fraud, mistreatment of patients, sexual violations and other crimes, the crux of their power – involuntary commitment laws -receives no focused attention.

Gottstein’s concept of a culture of recovery means the elimination of both involuntary commitment and the forced use of antipsychotics and other psychiatric drugs, in favor of the least restrictive alternative.

Antipsychotics, of course, are not a path to recovery. Several court rulings acknowledge the side effects and how patients have a right to decide what goes in their bodies. Of course, most all less restrictive alternatives to antipsychotics have been suppressed out of sight, making it appear that antipsychotics are the only answer, especially in a psychiatrist’s professional judgment.

According to Gottstein, the elimination of the forced use of psychiatric drugs is attainable through upholding of Constitutional Rights and extant legal opinions which have been subverted by:

1) Lying psychiatric expert witnesses,

2) Legal systems that accept, without evaluation, the utterances of such experts, and

3) The counter-intention and general failure of public defenders to actually defend the legal rights of the involuntarily committed person.

The paper shows an actual instance where mental health systems have knowingly acted in violation of the law in the guise of doing what is best for the patient (forced drugging)!

Point #3 above is what Gottstein emphasizes as the why of involuntary commitment. He cites one study that showed that the legal representation of people with mental disabilities was so bad that patients had a better chance of being released in a commitment hearing defending themselves pro se (without the aid of an attorney).

One of his projects is to cultivate willing lawyers who will zealously defend such plaintiffs and to have coordinators in every state working with these lawyers to actually handle cases.