Archive for May, 2009

The Human Face of the FDA’s Failure to Investigate Risky Medical Devices

Sunday, May 31st, 2009

On April 8th, the Food and Drug Administration announced its intention to finally require manufacturers of medical devices marketed prior to 1976 to submit evidence of the devices’ safety and efficacy. These devices had been “grandfathered” in and despite the FDA’s assessment that they posed serious risks to health, they were never required to undergo any clinical safety trials (as have devices sold in the past 33 years). One of these risky devices is the electroconvulsive therapy (ECT, or shock treatment) device.


Major media such as the New York Times and the Wall Street Journal quickly picked up on this story. Bloggers in particular zeroed in on the ECT device, with the general theme of incredulity: How could it that such a drastic procedure—applying electricity to the human brain to generate a dozen or more grand mal seizures—had been allowed to be used on a generation of patients (that’s over 3 million people even by the most conservative estimates) without ever having been tested to see if it were safe?


Indeed, this is the case; and it’s not news to readers of Linda Andre’s new book, Doctors of Deception: What They Don’t Want You to Know About Shock Treatment, published just a month before the FDA’s belated admission that it had essentially abdicated its responsibility to protect patients from harmful treatments.


The book is a history of shock treatment, with the emphasis on the history of the treatment since the 1970s. The author argues that this was a critical time for the shock industry, in part because the FDA’s assumption of the regulation of medical devices in 1976 and its classification of the ECT device in the high-risk Class III category in 1979 meant that—according to the law—the devices were to be subject to a safety investigation. No one knew at the time, nor could anyone have dreamed, that that day would not come for thirty years. The industry, Andre says, knew their treatment could not survive such scrutiny, so they adopted a public relations solution to what was essentially a scientific problem: They would make repeated claims for safety over the years, while lobbying the FDA to prevent any safety investigation from taking place.


At the same time former patients permanently damaged by shock treatment, as well as concerned citizens and scientists, lobbied the agency to conduct such an investigation. They lost, but not for lack of trying: They offered up their own brains for CAT-scans. They proposed animal brain scan studies. They submitted three formal citizen petitions to the agency, which the FDA essentially ignored…but in the process built up a public docket on the ECT device which takes a week to read (the author did so). They enlisted politicians and public health advocates as allies. They kept steady pressure on the FDA in every way they could think of for decades—but in the end the agency bent to the stronger pressure of the wealthy and powerful American Psychiatric Association.


It’s a dramatic David and Goliath story unparalleled in the history of medicine; and just last week, David was finally proven right.

It’s too late for a generation of patients who experienced permanent extensive amnesia and permanent cognitive disability, with the attendant loss of sense of self and of life chances. The author lets these former patients speak for themselves:


“I often feel as though a very vital part of my life ‘died’ as a result of these treatments.” “I do not think I will ever again be as intelligent a person as I was before.”

“ECT changed my life forever—and not for the better.”

“My personal belief is that an investigation is in order to prove that ECT is indeed beneficial and not brain damaging. How can I feel differently when that so-called therapy has wrecked a major portion of my life?”


“Doctors of Deception” makes clear that, at least in the case of the ECT device, the FDA’s failure to protect patients was not simply a matter of neglect or oversight; the agency had ample knowledge of the risks of the device and actively ignored repeated calls and opportunities to either conduct its own safety investigation or require the device manufacturers to do so.


The author reminds us that the FDA actually did call on shock machine manufacturers once before, in 1995, to prove their devices safe, but when the manufacturers simply ignored the call, the FDA did nothing. If history is any indication, the FDA is very likely to simply reclassify the ECT device to a low-risk category without any safety information or investigation at all rather than incur the wrath of the American Psychiatric Association.


At the very end of this cautionary tale, Andre writes: “Now that we know this history, now that what mostly hadn’t been written is written down in one place, maybe—just maybe—we can keep from repeating it. One thing is for certain: there will continue to be opportunities for the history of electroshock to take another turn.” Whether this will happen at the Food and Drug Administration or not, we will soon find out.


Links:

http://online.wsj.com/article/SB123920937438601763.html

“Medical Devices Face New Scrutiny from FDA” Wall Street Journal, April 8

http://www.fda.gov/bbs/topics/NEWS/2009/NEW01990.html

“FDA to Review Medical Devices Marketed Prior to 1976” April 8

http://psychcentral.com/blog/archives/2009/04/15/with-fda-change-ect-may-go-the-way-of-the-dinosaur/

“With FDA Change, ECT Machines May Go the Way of the Dinosaur” April 15

Foster children in Florida on powerful psychiatric drugs

Sunday, May 31st, 2009

St. Petersburg Times
Florida Department of Children and Families review finds shortfalls in monitoring of foster children on psychiatric drugs

By Kris Hundley, Times Staff Writer
In Print: May 29, 2008

Spurred by the shocking suicide of a 7-year-old on psychiatric drugs, the agency in charge of Florida’s foster children has discovered serious shortcomings in its monitoring of kids on such powerful prescriptions.

After reviewing its files, the Department of Children and Families determined it had under-counted the number of foster kids on such medications as Risperdal and Adderall, overlooking hundreds of cases.

It also has failed to meet its legal requirement that such prescriptions be given only after parental consent or court order.

On Thursday, DCF said a review of the files of more than 20,000 children currently in the state’s foster care showed 2,669, or 13.19 percent, are taking one or more psychotropic medications.

That compares to about 4 or 5 percent of children in the general population who are on such prescriptions.

Of those foster children taking drugs, DCF discovered 16 percent had no proof either a parent or judge had signed off on the prescription, as required by a 2005 Florida law.

“That is unacceptable,” said DCF’s secretary George Sheldon. “We’re going to bring every single case of a foster child on drugs into compliance with the law.”

Concerns about pediatric use of anti-psychotic and anti-depressants have been growing along with increased warnings of such side effects as suicide, diabetes and weight gain. Few of the drugs have been tested or approved by the FDA for children, though physicians can prescribe them for this age group.

Robin Rosenberg, a Tampa lawyer and deputy director of Florida’s Children First, said advocacy groups like hers have been fighting for oversight of psychotropic drugs for years. “We’re not as far along as we should have been if the state had followed up on serious concerns starting in the late 1990s,” she said. “It’s a shame we’re in this place today.”

Sheldon, who was named to the top job at DCF in October, left no doubt that he had been deeply affected by Gabriel Myers, the 7-year-old who hanged himself on a shower hose in south Florida in mid-April. The boy was in his third foster home and on Vyvanse, a medication for ADHD, as well as Symbyax, a combination of anti-psychotic and anti-depressant.

Though his caseworker repeatedly said Gabriel’s mother had agreed to the medications, that was not true. The boy’s psychotropic medications also had not been entered in the state’s tracking system.

To correct ongoing problems, Sheldon set a deadline of June 5 for action on cases without consent. This could include scheduling new doctors’ appointments, gaining informed consent from parents or expediting a judge’s review of the prescription.

Sheldon said he also was going to focus on the cases of 73 children under age 6 found to be on psychotropic drugs.

“I want a sense of urgency, but I also want to get it right,” he said. “I want to move forward, but I think it’s important for the agency to apologize for misinformation it may have put out in the past.”

Flaws in DCF’s record-keeping became clear in the immediate aftermath of Gabriel’s death. An initial review of the state’s database showed only 1,950 kids on psychotropic prescriptions. After a thorough review of individual records, however, that number grew by more than 700.

Preliminary data released in mid-May also showed some questionable dates on judicial consent. Though it’s not inconceivable a judge might sign an order on a Saturday or Sunday, early returns showed weekend consent orders on 129 occasions.

The final database, including information on types of drugs and diagnoses, was not available Thursday. Sheldon said a summary of the drug data would be posted on the DCF Web site and updated weekly.

“I’ve got a lot more confidence in these numbers than I had two weeks ago,” he said. “But any database is only as good as the quality of the information being put into it.”

One ongoing area of concern, Sheldon said, is the validity of any consent given by parents whose kids are in the state’s custody.

“A parent whose child is taken into our care is going to sign virtually anything and that’s not informed consent,” he said. “My preference is that the biological parent have a dialog with the psychiatrist.”

Now that DCF has a handle on the number of foster children on psychotropic drugs, Sheldon said the department can begin to address the bigger issue of the efficacy of such drugs.

He has asked an independent panel investigating Gabriel Myers’ death to make recommendations on improving DCF’s oversight of these medications. Sheldon said a second-party review of all such prescriptions might be necessary; currently, only prescriptions for kids under age 6 require such review.

DCF has set up a page on its web site that tracks the progress of the panel investigation into the boy’s suicide. The page includes a photo of the smiling boy.

“We have his face on the screen watching us to see how well we learned from his life and death,” Sheldon said. “We cannot let him down.”

Source: http://www.tampabay.com/news/health/medicine/article1005344.ece


Miami Herald
More Florida foster kids than thought are given mental-health drugs
A state database of foster-care records badly underreported the number of foster children on powerful psychiatric drugs, child-welfare bosses revealed.

In Print: May 29, 2008
By CAROL MARBIN MILLER

Nearly three of 10 teenage Florida foster children have been prescribed a mental-health drug, and 73 foster kids younger than 6 are taking mind-altering drugs, according to a study released Thursday in response to the death of a Broward foster child who was taking such medications.

In all, 2,669 children — or 13 percent of Florida foster children — are being given powerful psychiatric drugs, said the study, commissioned last month by Department of Children & Families Secretary George Sheldon. The largest group, almost 60 percent, are teens ages 13 to 17.

The 2,669 children represent about one-third more kids than a DCF database had reported as taking mental-health drugs — meaning electronic state records had significantly underestimated the use of mind-altering drugs.

Child-welfare administrators are investigating the use of mental-health drugs by children in state care in the wake of the April 16 death of Gabriel Myers, a troubled 7-year-old boy who hanged himself in the shower of his Margate foster home.

The Miami Herald reported that Gabriel had been given psychiatric drugs in his final weeks, including anti-depressants that are linked to a higher risk of suicide among children. Contrary to a 4-year-old law adopted after Herald stories, neither Gabriel’s parents nor a judge had consented to the use of such drugs.

”Normally, a 7-year-old boy is learning how to read and tie his shoes,” Sheldon said. “It is incomprehensible to me even now that a child so young may have deliberately and consciously made a decision to end his life.”

Sheldon, a former deputy attorney general, said he had ”serious questions” about the use of mental-health drugs on children. Many such drugs have never been approved by the Food and Drug Administration for use on children, and many are linked to serious side effects.

`CHEMICAL RESTRAINTS’

”I think this should be done as a last resort, after a full review by . . . medical professionals,” Sheldon said.

For almost a decade, Florida child advocates have complained that mental-health drugs are being used as ”chemical restraints” to control some foster kids.

On Thursday, Andrea Moore — a former head of Florida’s Children First who first suggested child-welfare workers were relying on mental-health drugs to control behavior — said the large number of older foster children and children in institutional settings makes such concerns far more pressing.

”The shift-care workers at group homes are much more likely to report sadness and crying as depression, or anxiousness as some sort of mental-health problem,” Moore said. “You’d be sad and anxious, too, if you didn’t know where you were going to live from day to day.”

Moore also expressed concerns that the data may not be trustworthy. Sheldon acknowledged Thursday that the numbers had not been compared with a database kept by the state’s Medicaid program. The agency also has acknowledged that caregivers were once told they did not need consents for mental-health drugs in certain cases — meaning the drugs may not be listed at all.

Among the 20,235 children whose case files were studied, investigators found no parental or judicial consent on record for 16 percent of the children, the report said.

Like previous studies, the new report shows that children in foster homes, group homes or other institutional settings are far more likely to be given mental-health drugs than children living with relatives. Overall, only 4 percent of children in relative care have been prescribed psychiatric drugs, compared with 21 percent for foster homes and 26 percent for other out-of-home settings.

COMPARISON

The disparity is particularly acute among older children: Among children 13 to 17, nearly 12 percent of those living with relatives have been prescribed at least one mental-health drug, compared with 35 percent in foster care and 33 percent in other institutional settings, the report says.

The private foster-care agencies in Miami-Dade and Broward fared about average in caring for the adolescents. Thirty percent of teens in the care of Our Kids in Miami-Dade had been given one or more mental-health drug, compared with 28 percent of Broward foster kids.

In contrast to the children in state care, about 4 to 5 percent of children in the general population are taking one or more mental-health drug, said Dr. Rajiv Tandon, a former DCF chief psychiatrist who belongs to a work group Sheldon appointed to study Gabriel’s death.

The report outlines steps DCF administrators will take, including:

• State child-welfare lawyers will seek consent from parents who still have authority to make decisions on their children’s behalf, or go to court to seek approval for mental-health drugs.

• Administrators are launching an ”immediate” review to determine how reliable the state’s child-welfare database is.

`IMPORTANT FIRST STEP’

• DCF administrators and the heads of private foster-care agencies throughout the state will discuss the use of psychiatric drugs by foster children weekly by telephone.

”The purpose of these calls is to ensure effective communication on improvements that must take place,” the report said.

”This report is an important first step in closely examining not only this case — but to help ensure this type of tragedy never happens again,” Sheldon said Thursday at a news conference.

Source: http://www.miamiherald.com/460/story/1070905.html

Benzodiazepines Linked to Post-ICU Depression

Thursday, May 28th, 2009

A recent article in MedScape Medical News says that “Intensive Care Unit (ICU) patients with adult respiratory-distress syndrome (ARDS) and other forms of acute lung injury (ALI) may need sedation to endure the stress of mechanical ventilation, but the benzodiazepine doses often used in this situation may be setting patients up for clinical depression after discharge.

In a study published in the May issue of Critical Care Medicine, David W. Dowdy, MD, PhD, and colleagues, from the Johns Hopkins University School of Medicine, in Baltimore, Maryland, identified several factors associated with symptoms of depression 6 months after ICU admission for ALI. These included … high benzodiazepine doses…”

Benzodiazepines are a class of psychiatric anti-anxiety drugs also called minor tranquilizers or sedative hypnotics. Some of the various brand names are Valium, Xanax, Klonopin, Librium, and Rohypnol.

Daily use of therapeutic doses of benzodiazepines is associated with physical dependence. Addiction can occur after 14 days of regular use. The withdrawal syndrome is similar to that of alcohol withdrawal, but can be more prolonged and more difficult than withdrawal from heroin. Typical consequences of withdrawal are depression, anxiety, sweating, cramps, nausea, psychotic reactions and seizures. Some of the side effects of taking these drugs include depression, aggressive behavior, anxiety, psychosis, and suicide.

Drug experts say that the benzodiazepine Xanax, for example, is more addictive than most illegal drugs, including cocaine or heroin.

More information about the side effects of psychiatric drugs can be found by clicking here.

[Editorial Comment: One wonders why a psychiatric drug with such already known severe side effects and withdrawal symptoms is used at all in an intensive care unit after a severe illness.]

Top APA Shrink Needs Lesson in Disease vs. Disorder

Thursday, May 28th, 2009

Read the quotes below from psychiatrists / psychologists who admit psychiatric disorders are not diseases (but not the APA President).

Then watch the video at http://youtube.com/cchrint.

“Psychiatry makes unproven claims that depression, bipolar illness, anxiety, alcoholism and a host of other disorders are in fact primarily biologic and probably genetic in origin…This kind of faith in science and progress is staggering, not to mention naïve and perhaps delusional.”

— Dr. David Kaiser, psychiatrist

“In short, the whole business of creating psychiatric categories of ‘disease,’ formalizing them with consensus, and subsequently ascribing diagnostic codes to them, which in turn leads to their use for insurance billing, is nothing but an extended racket furnishing psychiatry a pseudo-scientific aura. The perpetrators are, of course, feeding at the public trough.”

— Dr. Thomas Dorman, internist and member of the
Royal College of Physicians of the UK

“I believe, until the public and psychiatry itself see that DSM labels are not only useless as medical ‘diagnoses’ but also have the potential to do great harm—particularly when they are used as means to deny individual freedoms, or as weapons by psychiatrists acting as hired guns for the legal system.”

— Dr. Sydney Walker III, psychiatrist

“The way things get into the DSM is not based on blood test or brain scan or physical findings. It’s based on descriptions of behavior. And that’s what the whole psychiatry system is.”

— Dr. Colin Ross, Psychiatrist

“There’s no biological imbalance. When people come to me and they say, ‘I have a biochemical imbalance,’ I say, ‘Show me your lab tests.’ There are no lab tests. So what’s the biochemical imbalance?”

— Dr. Ron Leifer, psychiatrist

“Unlike medical diagnoses that convey a probable cause, appropriate treatment and likely prognosis, the disorders listed in DSM-IV [and ICD-10] are terms arrived at through peer consensus.”

— Tana Dineen Ph.D., Canadian psychologist

“No biochemical, neurological, or genetic markers have been found for Attention Deficit Disorder, Oppositional Defiant Disorder, depression, schizophrenia, anxiety, compulsive alcohol and drug abuse, overeating, gambling or any other so-called mental illness, disease, or disorder.”

— Bruce Levine, Ph.D., psychologist and
author of Commonsense Rebellion

Stress Testing the MOTHERS Act

Saturday, May 23rd, 2009

by Kelly Patricia O’Meara

It seems these days that everything is a test. Yes, the powers that be have decided that taxpayer benevolence now is contingent upon passing a stress test. But much to the dismay of those being tested, the results may reveal, for example, that the nation’s financial wizards and auto giants are actually bankrupt midgets and unworthy of America’s support.

Given that officialdom has embraced the stress test as a barometer of future viability and success and a determinant for public financing, it seems reasonable to request that other important issues that very personally impact the health and welfare of the American people be subjected to similar stress tests. There is none more deserving of stress testing than the proposed MOTHERS Act.

On the surface, the MOTHERS Act reflects its sponsors overwhelming compassion and empathy for women suffering from alleged mental health disorders resulting from childbirth – often referred to as Postpartum Depression. But when one conducts a brief stress test on important sections of the legislation, taxpayers may find that this costly and sweeping mental health legislation actually fails women of America, but goes a long way in inflating the balance sheets of one of the most lucrative industries in the nation – big Pharma.

For instance, the MOTHERS Act legislation that currently is pending in the U.S. Senate states that the Secretary of Health and Human Services may “make grants to eligible entities…” to deliver essential services to individuals with a postpartum condition. What the legislation doesn’t delineate is who and what entities may receive these grants. Are these “entities” funded by pharmaceutical companies?  Lawmakers have not specified what constitutes an “entity” so it will be impossible to know if there are conflicts of interest between those who develop the screening tools and conduct research and the pharmaceutical companies who most certainly will benefit financially from the increased diagnosing.

Furthermore, no research guidelines have been provided for public disclosure. This is no small issue, given that the Senate Finance Committee recently exposed the conflicts of interest of the top ten psychiatric researchers in the U.S. who had received millions of dollars in pharmaceutical funding. Where is the guarantee that the “entities” are not pharmaceutical front-men?

The legislation also allows for the “expansion and intensification of activities” into the research of Postpartum conditions and “evaluation of new treatments.” This is a humdinger. Despite ever-increasing published data and clinical studies challenging the safety of antidepressants and other antipsychotic drugs, there is no guidance provided by lawmakers to mandate that the public be made aware of the avalanche of scientific data that not only questions the efficacy of the drugs available to mothers suffering from these conditions, but also warning of the dangers associated with currently available “treatments.”

The section of the legislation dealing with expanding the research into the causes of Postpartum conditions is wholly void of any guidelines that insure the validity of the research conducted, and provides nothing in the way of public disclosure or peer-review of research before it is launched in education campaigns. In the real world, research is conducted and submitted for peer review. In this instance, it appears that Congress has learned nothing from the ongoing banking debacle and naively believes that the researchers will be on their best behavior – self-policing themselves. This is a dangerous omission in the legislation, especially since the Senate Finance Committee has exposed the serious conflicts of interest that exist between researchers and pharmaceutical companies.

Making matters worse, much of the legislation revolves around funding national education campaigns about Postpartum Depression, including Public Service Announcements and television and radio advertisements. Based on the current language of the legislation, research will be conducted without peer review – no checks and balances; no one to validate the integrity of the research which then will be used to determine a woman’s mental health status. Given that this research will be used to develop questions or tests for screening new mothers for possible mental disorders, one might find it important to know that the research has integrity and has been validated by the scientific community, free of pharmaceutical largesse. Congress apparently didn’t think integrity of the research is important and there are no provisions to protect women from pharmaceutical driven research.

Taxpayers may also expect that such important legislation would make provisions for some kind of oversight; some government entity that could provide feedback on the success or failure of this mental health campaign. One avenue that may help lawmakers’ determine if these new programs are working is the Food and Drug Administration’s MedWatch Adverse Event Reports. MedWatch collects information about people who have experienced adverse reactions to drugs overseen by the FDA. With the increased drugging that most certainly will occur with the increase in diagnosing, it seems logical that lawmakers would insert provisions in the legislation to annually review Adverse Event Reports collected by MedWatch, especially those relating to drugs prescribed in the treatment of Postpartum Depression. Unfortunately, because the nation’s lawmakers have provided no provisions for oversight, countless numbers of women may be harmed by the “treatments” but will be none the wiser because no protections were provided in the legislation.

There also is the very basic question of why the government is endorsing this sweeping mental health legislation and sanctioning a national advertising campaign about Postpartum Depression when there is no definitive data about the cause of the condition or that it is an objective confirmable abnormality – the scientific standard for disease. Given that there are so many unknowns in this legislation, it seems irresponsible to go forward without reasonable protections in place.

Congress must insure that all research and screening tests proposed and endorsed by this legislation be disclosed for peer-review and consumer input before implementing any screening tests and approving any research to be used in the national education campaign, including Public Service Announcements and radio and television advertising.

Given the documented risks related to the current modes of treatments, including antidepressant and antipsychotics, which are commonly prescribed for Postpartum Depression and documented to cause birth defects and host of other issues in pregnant and nursing mothers, Congress must include mandatory reviews of published research and clinical data on the drugs prescribed for the treatment of Postpartum Depression.

Finally, Congress must protect the integrity of the research by providing strict guidelines to insure that there are no conflicts of interest between the researcher and the pharmaceutical industry.

Without these safeguards, the MOTHERS Act cannot today, or ever, pass a stress test of viability and mothers and their children certainly will be on the losing end of this mental health campaign. Sometimes it’s in the best interest of the people for Congress NOT to act, and until our lawmakers are confident that all legislative precautions have been taken to insure optimum results, this is one of those times.

About the author:

Kelly Patricia O’Meara is an award-winning investigative journalist who authored more than two dozen articles examining the psychiatric pharmaceutical industry during her tenure at the Washington Times’ Insight Magazine. Her articles resulted in record sales of the issues in which they appeared and among the national and international press that have featured her articles are Fox News, the O’Reilly Factor, CBS News, BBC, ABC’s 20/20 and Hannity and Colmes. She is also the author of Psyched Out: How Psychiatry Sells Sickness and Pushes Pills that Kill. Prior to working as an investigative journalist, O’Meara spent sixteen years on Capitol Hill and was the lead investigator in several Congressional investigations. She holds a B.S. in Political Science from the University of Maryland.


Please contact the Senate HELP (Health, Education, Labor and Pensions) Committee to express your opposition to H.R. 20. Go to http://uniteforlife.wordpress.com/2009/04/17/stop-the-mothers-act-action-day-all-over-earth-day-for-healthy-births-day/ for more information, and contact your Senator to let them know what you think.

Parental Consent Act to protect families from mandatory mental health screening

Wednesday, May 13th, 2009

(NaturalNews) Rep. Ron Paul has introduced the Parental Consent Act [H.R. 2218] to protect families from mandatory “mental health screening” — a thinly-veiled attempt by Big Pharma to drug expectant mothers and new moms with dangerous psychiatric drugs.

Here’s the full text of the speech given by Ron Paul in the House of Representatives, April 30, 2009:

Madam Speaker, I rise to introduce the Parental Consent Act. This bill forbids Federal funds from being used for any universal or mandatory mental-health screening of students without the express, written, voluntary, informed consent of their parents or legal guardians. This bill protects the fundamental right of parents to direct and control the upbringing and education of their children.

The New Freedom Commission on Mental Health has recommended that the federal and state governments work toward the implementation of a comprehensive system of mental-health screening for all Americans. The commission recommends that universal or mandatory mental-health screening first be implemented in public schools as a prelude to expanding it to the general public. However, neither the commission’s report nor any related mental-health screening proposal requires parental consent before a child is subjected to mental-health screening. Federally-funded universal or mandatory mental-health screening in schools without parental consent could lead to labeling more children as “ADD” or “hyperactive” and thus force more children to take psychotropic drugs, such as Ritalin, against their parents’ wishes.

Already, too many children are suffering from being prescribed psychotropic drugs for nothing more than children’s typical rambunctious behavior. According to Medco Health Solutions, more than 2.2 million children are receiving more than one psychotropic drug at one time. In fact, according to Medico Trends, in 2003, total spending on psychiatric drugs for children exceeded spending on antibiotics or asthma medication.

Many children have suffered harmful side effects from using psychotropic drugs. Some of the possible side effects include mania, violence, dependence, and weight gain. Yet, parents are already being threatened with child abuse charges if they resist efforts to drug their children. Imagine how much easier it will be to drug children against their parents’ wishes if a federally-funded mental-health screener makes the recommendation.

Universal or mandatory mental-health screening could also provide a justification for stigmatizing children from families that support traditional values. Even the authors of mental-health diagnosis manuals admit that mental-health diagnoses are subjective and based on social constructions. Therefore, it is all too easy for a psychiatrist to label a person’s disagreement with the psychiatrist’s political beliefs a mental disorder. For example, a federally-funded school violence prevention program lists “intolerance” as a mental problem that may lead to school violence. Because “intolerance” is often a code word for believing in traditional values, children who share their parents’ values could be labeled as having mental problems and a risk of causing violence. If the mandatory mental-health screening program applies to adults, everyone who believes in traditional values could have his or her beliefs stigmatized as a sign of a mental disorder. Taxpayer dollars should not support programs that may label those who adhere to traditional values as having a “mental disorder.”

Madam Speaker, universal or mandatory mental-health screening threatens to undermine parents’ right to raise their children as the parents see fit. Forced mental-health screening could also endanger the health of children by leading to more children being improperly placed on psychotropic drugs, such as Ritalin, or stigmatized as “mentally ill” or a risk of causing violence because they adhere to traditional values. Congress has a responsibility to the nation’s parents and children to stop this from happening. I, therefore, urge my colleagues to cosponsor the Parental Consent Act.
——————————————————————————–
Take Action!

Ask your Representative to co-sponsor H.R. 2218.

Five dead at US base in Baghdad after soldier opens fire

Tuesday, May 12th, 2009

“A US soldier was in custody in Baghdad today after allegedly killing five other military personnel and wounding three. The Pentagon confirmed that a soldier had opened fire at Camp Liberty, a US base just outside Baghdad and next to the international airport. The incident was one of the highest death tolls for the American military in recent months. The Associated Press reported a US official as saying that the shooting took place at a stress clinic, where soldiers suffering mental problems can go for treatment or counselling.” [by Ewen MacAskill in Washington for guardian.co.uk, Monday 11 May 2009]


How can we be at the dawn of the twenty-first century with technology hurtling us into a space age future and yet continue to find ourselves without a solution to the escalating number of acts of random, senseless violence?

The reason is that we have been fed all manner of wrong reasons for why these tragedies have taken place and so they continue. It is not guns that are the common denominator to these horrific events—some occur with knives, axes and even automobiles. Nor is it clothing, age, gender or political orientation.

The fact missed by most is that psychiatric, mind-altering drugs have been found to be the common factor in an overwhelming number of these acts of random senseless violence.

These drugs, on an ever increasing rise in society, in the military, and amongst schoolchildren, particularly over the last two decades, are actually creating acts of violence. The scientific research documenting the connection between violence, suicide and psychiatric drugs is overwhelming.

On the surface, the idea of tranquilizers or antidepressants creating hostility and violence may not make sense. After all, they are supposed to make people calm and quiet. But the reality is that they can and do create such adverse effects. Psychiatric drugs and treatments do create violence and the sooner we recognize this and do something about it, the sooner these kinds of killings will stop.

Last year the rate of suicide in the military exceeded that of the general population, and is highest since the Army began tracking it in the 1980s. A sizable and growing number of U.S. combat troops are taking daily doses of antidepressants, according to a June, 2008 report in Time Magazine.

Click here for more information about psychiatry and the creation of senseless violence.

Click here for more information about the side effects of psychiatric drugs.

Officials order look at drug use of Florida foster children

Monday, May 11th, 2009
South Florida Sun-Sentinel
After 7-year-old’s suicide, officials order look at drug use of other Florida foster children

MARGATE – In the aftermath of 7-year-old Gabriel Myers’ suicide, state child welfare officials will review the case files of every foster child in Florida to see how many are on mind-altering drugs.

The head of the Department of Children & Families also took the rare step Wednesday of appointing a panel to examine the circumstances surrounding Gabriel’s death. The child hanged himself April 16 with a shower hose in the bathroom of his Margate foster home.

“It is difficult for any of us to comprehend how a child so young could have deliberately and consciously made the decision to end his life,” DCF Secretary George Sheldon said. “But in order to help prevent this type of tragedy from happening again, it is critical we review all available information to determine the factors that led to Gabriel’s death.”

Four weeks before his suicide, Gabriel was prescribed Symbyax, which is a combination of the generic forms of the anti-depressant Prozac and the anti-psychosis drug Zyprexa. He already had been taking Vyvanse, a drug to treat attention deficit/hyperactivity disorder.

Sheldon has asked his agency to examine how many of the more than 20,000 foster children in Florida are taking psychotropic drugs. A DCF study in 2005 concluded that one in every four foster children was on a mood-altering drug.

Child advocates in the state have long criticized what they have described as the rampant use of psychotropic drugs on foster children.

“One of our concerns is that they use the medications as ‘chemical restraint’ and not as a medication to treat a disease or condition,” said Andrea Moore, executive director of Florida’s Children First.

Child welfare records released last week indicate Gabriel started taking Symbyax even though there apparently was no court order in place. Under Florida law, parental consent or a judge’s order is needed before a foster child can be administered a psychotropic drug.

“We need to develop a refined protocol for the use of these types of drugs in our children,” Sheldon said. “I want to ensure that prescription drugs of this nature are used appropriately, always under medical and judicial supervision and with consultation with DCF staff.”

To delve into Gabriel’s death, Sheldon appointed a five-member panel to be led by Jim Sewell, a former assistant commissioner with the Florida Department of Law Enforcement.

Jon Myers, Gabriel’s uncle, said he hopes that something good will come out of DCF’s actions.

“We realize (child welfare officials) have a tough job and the idea is that they learn from this and pass some laws which are in the best interest of the children,” Myers said.

Letters to the editor here: letters@sun-sentinel.com

Lack of Vitamin D can cause depression

Saturday, May 9th, 2009

According to the St. Louis Post-Dispatch, researchers at Washington University School of Medicine studying the effects of vitamin D deficiency on the elderly have found a correlation of mild depression and forgetfulness with low levels of vitamin D, and as many as 75 percent of older adults suffer from a vitamin D deficiency.

[Editorial Comment: recently we purchased a bottle of Vitamin D at Trader Joe’s; compared to a bottle of prescription anti-depressant, it was loads cheaper and has no side effects. Your body can have a vitamin D deficiency that can cause mental symptoms; your body does not have a deficiency of any prescription anti-depressant drug. Drugs like these can only mask symptoms, they cannot and never will cure anything.]

Numerous studies show that undiagnosed and untreated physical problems can cause behavioral and emotional problems. Patients with actual physical conditions are routinely misdiagnosed with psychiatric disorders, then drugged and institutionalized. According to UCLA medical professor, Melvyn R. Werback, physicians diagnosing mental illness should check the patient’s dietary history and other nutritional factors. One state’s mental health evaluation field manual says that mental health professionals have a “legal obligation to recognize physical disease” that “may cause a patient’s mental disorder.”

Proper medical screening by non-psychiatric diagnostic specialists could eliminate more than 40% of psychiatric admissions. The emphasis of any mental health solution must be based on workable mental healing methods, beginning with a non-psychiatric medical examination of the patient and a diagnosis of any treatable physical ills affecting mental well-being.

Click here for more information about psychiatry’s false diagnoses.

Just Say No to the Mothers Act

Wednesday, May 6th, 2009

by Evelyn Pringle 4-27-09

The customer base the psycho-pharmaceutical industry is hoping to corral through passage of the Mothers Act [H.R. 20] is the more than four million women who give birth in the US each year. That number was 4,317,119 in 2007, according to the CDC.

The Act’s passage, after eight years of solid efforts, would set the stage for the screening of all pregnant women for a whole list of mental disorders. The bill has already passed in the US House of Representatives and will soon be up for a vote in the Senate.

The definition section of the Act specifically states that the term “postpartum condition” means “postpartum depression or postpartum psychosis.” There is not one word about perinatal “mood” or “anxiety” disorders in the bill.

The transformation of the postpartum language in the Act to further the formation of a new cottage industry for treating multiple disorders can be traced back to websites such as Postpartum Progress, Postpartum Support International, and a site called PerinatalPro, which leads directly to the treatment center owned by the site’s creator Susan Stone.

On January 26, 2009, Susan cranked out an announcement on the internet with the headline: “U.S. Senator Robert Menendez reintroduces important postpartum depression legislation in Senate today!!”

However, in Stone’s message to the pubic the “postpartum depression” in the headline suddenly transforms into “perinatal mood disorders,” and she warns of a crisis of epidemic proportions in stating:

“The statistics we have on the numbers of women suffering from perinatal mood disorders (which range from 12 – 22% in the research) easily exceed the incidence associated with a public health crisis.”

“And remember,” she says, “these statistics, do NOT include the suffering of women who miscarry, endure stillbirths, give up babies for adoption or terminate pregnancies, all of whom are also susceptible to these devastating disorders and whose circumstances are included in the furthering of research and support being sought.”

In her message, Susan reports: “Today, I had the joy of participating in a conference call with the office of Senator Menendez and the other organizational sponsors of The Melanie Blocker Stokes MOTHERS Act where we received a heads up that U.S. Senator Robert Menendez was hoping to reintroduce the bill today.”

While the Mothers Act refers to helping women with postpartum depression and psychosis only, the bill’s top promoters, obviously kept in the loop by the main sponsor in the Senate, clearly have a larger customer recruitment scheme in the works.

On a Postpartum Progress page with a heading, “WHAT IS WRONG WITH ME?!” the website’s creator, Katherine Stone, explains that the word perinatal “refers in this case to the period during and after pregnancy.”

“Among the mental disorders women face during this time, there are two main types: anxiety disorders and mood disorders,” she advises.

“Anxiety disorders include generalized anxiety disorder, obsessive compulsive disorder, post-traumatic stress disorder and panic disorder,” she reports.

“Mood disorders include depression, bipolar disorder and psychosis,” she explains. Under the heading “Postpartum Post-Traumatic Stress Disorder,” she writes:

“All you have to do to be at risk for getting postpartum PTSD is to have the perception of a traumatic childbirth — in other words, even if your doctors and nurses feel that everything went fairly normally, if it was upsetting and scary and unexpected to you that’s what counts.”

She concludes with the misleading statement that, “all of these illnesses are completely treatable.”

Katherine’s bio claims she “is a nationally-recognized, award-winning advocate for women with perinatal mood and anxiety disorders.”

In the Menendez press release on January 26, 2009, there was no mention of “mood” and “anxiety” disorders. If he was not in on this disease mongering plot, he would have told these two broads to knock it off by now.

Drugging for profit

Although no psychiatric drug has been FDA approved as safe for use by pregnant and nursing mothers, the treatment for all the perinatal mental disorders calls for the new generation of antidepressants, along with atypical antipsychotics and epilepsy drugs, now commonly referred to as “mood stabilizers.”

The atypical antipsychotics are Seroquel by AstraZeneca, Risperdal and Invega marketed by Janssen, a division of Johnson & Johnson, Geodon by Pfizer, Abilify from Bristol-Myers Squibb, Novartis’ Clozaril, and Eli Lilly’s Zyprexa. The average price for these drugs on DrugStore.com is about $900 for a hundred pills.

The SSRI and SNRI antidepressants include GlaxoSmithKline’s Paxil and Wellbutrin, Pfizer’s Zoloft, Celexa and Lexapro from Forest Labs, Luvox by Solvay, Wyeth’s Effexor and Pristiq, and Lilly’s Prozac, Cymbalta, and Symbyax, a pill with Zyprexa and Prozac combined. The price of these drugs, on average, is about $300 for ninety pills at DrugStore.com.

On March 23, 2009, Philip Dawdy reported on the popular website Furious Seasons, that “in a sign of just how bizarre things have gotten in DC, the FDA today approved Symbyax for treatment resistant depression, meaning depression that hasn’t responded to two anti-depressants.”

“So the FDA just approved a drug that’s known to cause diabetes, epic weight gain and suicidality to treat depression,” he said. “This makes so much sense!”

The antipsychotics are now the top money-makers. In overall prescription sales in the US, they led all classes of drugs in 2008, with sales of $14.6 billion, according to IMS Health. Anticonvulsants came in fourth with $11.3 billion in sales, followed by antidepressants at fifth with sales of $9.6 billion.

The Epilepsy Foundation estimates that one million women in the US have epilepsy, but the number of women taking anticonvulsants is reported to be two to three times higher than women with epilepsy. The prices for these drugs can run as high as $929 for 180 tablets of Glaxo’s Lamictal, and $1170 for 180 tablets of J&J’s Topamax.

Numerous recent reports have linked the use of drugs such as Depakote, Neurontin, Lamictal and Tegretol with not only suicide but also birth defects, including heart defects, brain damage, and mental retardation.

Big Pharma funds Mothers Act supporters

As of April 9, 2009, the groups supporting the Mother’s Act listed on PerinatalPro with Big Pharma funding traceable through their annual reports and the grant reports of Eli Lilly and Pfizer for 2007 and 2008, include the American College of Obstetricians and Gynecologists, American Psychiatric Association, Association of Maternal and Child Health Programs, Children’s Defense Fund, Depression and Bipolar Support Alliance, March of Dimes, Mental Health America (MHA), National Alliance for the Mentally Ill (NAMI), National Association of Social Workers, National Council for Community Behavioral Healthcare, and the Suicide Prevention Action Network USA.

Pfizer’s 2008 grant report shows the Association of Maternal and Child Health Programs, received $10,000 for “General Operating Support.” Florida’s Bureau of Maternal and Child Health received funding from Lilly and Pfizer to launch a three-pronged maternal depression awareness initiative consisting of education, screening and advocacy, according to the July, 2005 paper, Improving Maternal and Infant Mental Health: Focus on Maternal Depression, by Ngozi Onunaku.

Collaborating partners also included the American College of Obstetricians and Gynecologists, University of Miami, and Florida’s Department of Mental Health, Onunaku reports. Public awareness efforts reached the Florida State Legislature, who passed a resolution to establish April as women’s depression screening month.

Onunaku listed the Lilly and Pfizer funded Florida project as an example of state and community efforts that may be useful in reaching the goal of increasing maternal depression awareness. In the paper, he reported the following:

“Prenatal depression occurs during pregnancy when mothers-to-be experience hormonal and biological changes, stress, and the demands of pregnancy. Approximately 14-25% of pregnant women have enough depressive symptoms to meet the criteria for a clinical diagnosis.

“The use of medication to treat maternal depression is controversial; there is concern about mothers taking medication during pregnancy and after delivery, especially while breastfeeding. Research suggests that infant development is not adversely affected by certain kinds of medication.

“There is equal consideration regarding the possible risks posed to a child whose mother is severely depressed and needs medication but remains untreated.

In 2008, Lilly gave the American College of Obstetricians and Gynecologists $16,000, and a $2,000 donation was made in the third quarter of 2007.

Lilly gave the American Psychiatric Association grants worth more than $600,000 in both the first and second quarters of 2008. In 2007, the group received over $400,000 from Lilly. The drug maker gave roughly $450,000 more to the American Psychiatric Foundation for the APA fellowship program. Pfizer donated more than $700,000 to the “non-profit” APA in 2008.

The National Council for Community Behavioral Healthcare is described as “a non-profit association representing 1,300 mental health and addictions treatment and rehabilitation organizations,” on its website. This gang received $200,000 from Lilly in the first quarter of 2008, and another $215,000 in the fourth quarter.

Mother’s Act supporter, Suicide Prevention Action Network USA, has merged with the American Foundation for Suicide Prevention, according to a November 6, 2008 press release announcement.

A year earlier, Emory University reported that Charles Nemeroff had been elected president of the American Foundation for Suicide Prevention and would begin serving his three-year tenure in January 2008.

Emory’s press release noted that Nemeroff had served on the AFSP’s national board of directors since 1999 and had “been a member of the Foundation’s Scientific Council for more than 10 years and was named chair of the Council in 2007.”

In about the same time frame between 2000 and 2007, Senator Charles Grassley’s Senate Finance Committee investigation found that Nemeroff had earned more than $2.8 million from drug companies, but failed to disclose at least $1.2 million to Emory.

On November 3, 2008, Dr Bernard Caroll summed up Nemeroff’s fall from grace on the Healthcare Renewal website as follows:

“The fallout to date includes his severance from several NIH-funded projects at Emory University School of Medicine, a freeze of NIH funding for a major center grant, and his stepping down from Emory’s chair of psychiatry while an internal investigation proceeds.”

Dr. Nemeroff’s credibility is under a cloud, to say the least, and his influence is rapidly waning. … In the hardnosed, commercial world of Continuing Medical Education, for instance, the signs are that Dr. Nemeroff is toast. Whereas he once coordinated multi-city traveling CME road shows and a parade of spots on CME websites like Medscape, his profile now is suffering. Go to this Medscape website, for instance. You will find that his current Expert Viewpoint spots are missing, replaced by the message, “This article is temporarily unavailable.”

Nemeroff’s Bio on the Emory Website on December 22, 2008 listed his Clinical Interests as: “Depression and antipsychotic pharmacological therapy, social phobias, fetal effects of pre- and post-natal drug therapy, depression, mood disorders, antipsychotic therapy.”

Lilly’s 2008 grant report shows the Suicide Prevention Action Network USA received one $10,000 grant and another $70,000 grant. The American Foundation for Suicide Prevention also received three grants worth $78,000.

Lilly’s 2007 report shows the Action Network received $10,000 in one quarter and $70,000 in another. The Foundation got $25,000 in 2007. The 2004 spring issue of USA’s Network News reports that: “Network News is funded by a grant from the Eli Lilly and Company Foundation.”

The Summer 2005 Network News noted that “Donations Sustain SPAN USA.”

The donor list shows Pfizer gave over $10,000. The group received more than $1,000 from Bristol-Meyers, Janssen, and Novartis. Forest Pharmaceuticals gave over $500.

The 2006 Spring Network News announced the “Friend for Life” sponsors. Forest and the industry’s trade group, PhRMA donated over $15,000. Pfizer gave between $10,000 and $14,999. Solvay was listed as giving between $6,000 and $9,999 and companies that gave between $2,000 and $5,999 were AstraZeneca and Bristol-Myers. J&J, Lilly and Novartis each donated between $500 and $1,999.

As expected, the two most notorious front groups, NAMI and MHA, received the most money from psychiatric drug makers. NAMI’s annual reports list about every drug company on the planet as a corporate partner without specifying how much each donated. But the grant reports of Lilly and Pfizer for 2007 and 2008 show NAMI groups received millions of dollars from those two drug makers alone.

In the fourth quarter of 2008, Pfizer gave NAMI a grant of $132,000 to fund a campaign that best describes the drug maker’s goal called the “Campaign for the Mind of America.” In the third quarter, Pfizer doled out another $225,000 to fund the same campaign.

Lilly is also funding the Campaign for the Mind, with grants of $450,000 in both 2007 and 2008. Lilly also provides extra funding to NAMI groups all over the country for the “Walk for the Mind of America.” In 2007, walking money totaled $17,000 in the first quarter, $11,500 in the second, and $13,000 for the third and fourth combined. In 2008, Lilly’s “Walk for the Mind” quarterly totals were $11,500, $24,000, $12,500 and $2,000.

In 2007, NAMI presented a $50,000 “Mind of America Scientific Research Award” to Dr A John Rush. He also landed on the Grassley hit list last fall for not disclosing drug company money to the University of Texas.

On April 6, 2009, Senator Grassley sent a letter to NAMI asking for the disclosure of all funding from drug makers and industry created foundations over the past few years.

Mental Health America groups also received millions of dollars from Pfizer and Lilly alone in 2007 and 2008. This group runs a “Campaign for America’s Mental Health” and received grants of $200,000 and $300,000 in 2008 from Pfizer to fund it. Lilly gave $300,000 to fund this Campaign in 2007.

MHA’s 2006 annual report shows the group received over $1 million each from Lilly, Bristol-Myers, and Wyeth. Janssen and Pfizer gave between $500,000 and $1,000,000, and AstraZeneca and Forest donated between $100,000 and $499,000. Glaxo gave between $50,000 and $100,000 in 2006.

The most troubling donation to this Mothers Act supporter is a $20,000 Pfizer grant to a Georgia group to fund: Project Healthy Moms: Education for Prevention/Treatment for Perinatal Depression Disorders, which apparently ended up, at least in part, in the pocketbook of Katherine Stone.

The Georgia group’s June 8, 2008 e-news said the grant was for: “Project Healthy Moms: What You Need To Know About Perinatal Mood Disorders.”

The $20,000 funded 1-hour speaking events with Katherine, “aimed at educating practitioners and the general public throughout Georgia about prevention of and treatment for such illnesses as ante partum depression, postpartum depression, postpartum anxiety/OCD and postpartum psychosis,” the newsletter said.

Katherine was described as a “former postpartum OCD sufferer and author of Postpartum Progress, the most widely-read blog in the United States on postpartum mood disorders.”

E-news said attendees would learn: “One size does NOT fit all: Why postpartum depression is just part of a spectrum of mood disorders women may experience & what to look for.”

The newsletter only listed 5 scheduled events but told readers to contact Katherine directly by email or phone to schedule more. E-news did acknowledge that: “This special hour of learning is made possible by a grant from Pfizer,” but listed no amount.

The leaders of these “non-profits” are also making out like bandits. In 2006, NAMI’s top dog, Michael Fitzpatrick, had a salary of $212,281, and $10,090 in employee benefit contributions and deferred compensation plans, for a 35-hour work week.

MHA’s 2002 tax returns show the CEO and President, Michael Faenza, received compensation of $306,727, and another $35,275 in contributions to employee benefit plans and deferred compensation that year, for a 35 hour work week.

The Depression and Bipolar Support Alliance received $37,510 from Lilly in 2007 and $20,000 in 2008. This group provides live links to form letters that can be filled in and sent to Congress members asking them to vote for the Mother’s Act. The two Stone gals provide links to the Mothers Act alerts put out by the Alliance on their websites.

The group’s 2007 Annual Report shows this non-profit received between $150,000 and $499,000 from AstraZeneca, Pfizer, and Wyeth. Abbott, Cyberonics, Lilly, Forest, Glaxo, Organon, and Otsuka American Pharmaceuticals gave between $10,000 and $149,999.

The report also notes that a “First-ever DBSA Hope Award” for lifetime achievement was presented to Frederick Goodwin. Back in August 2002, the speakers at the annual conference of the Alliance included three stars from the Grassley hit list, Goodwin, Nemeroff and Joseph Beiderman.

The front groups team up with a “non-profit” called “Screening for Mental Health,” to carry out mental illness screening days all over the country every year. Their websites also provide live links to internet screening programs set up by this firm.

Up to 2008, the SMH had received close to $5 million from drug companies. Lilly gave the firm $124,000 in 2007 and $100,000 in 2008.

Finally, the Children’s Defense Fund received a grant for $125,000 in 2003 from the Robert Wood Johnson Foundation. The March of Dimes got $6,500 from Pfizer in 2008, and the National Association of Social Workers also received $7,500 from Pfizer.

Amy Philo, a young Texas mother who survived what can only be described as a postpartum ambush by the psycho-pharmaceutical cartel, is at the forefront of the “Unite for Life” coalition fighting against the Mothers Act. As of April 25, 2009, the Unite coalition had thirty-five organizations signed on as opposed to the legislation. Needless to say, none of them were listed in the grant reports of Lilly or Pfizer.

Amy was screened and drugged because she got extremely concerned about her baby and had a panic attack after watching him nearly choke to death. “I lived through forced hospitalization, drugging, and four months of being homicidal, suicidal, and psychotic because of Zoloft,” she recounts on her website.

“No mother should have to live through what I have,” she states.

Over a recent three to four year period, Amy found there were 1,031 documented deaths of babies caused by psychiatric drug exposure reported to the FDA’s MedWatch system.

Amy recently learned that the National Association of Certified Professional Midwives has withdrawn their support from the Mothers Act. However, she reports a new addition to the list of supporters is the National Healthy Mothers, Healthy Babies Coalition. A quick check of their website found the group’s corporate sponsors include Wyeth, Glaxo, J&J, Merck, and Sanofi Pasteur.

*************

Evelyn Pringle

epringle05@yahoo.com

(This article was sponsored by the Pogust, Braslow & Millrood law firm in Conshohocken, Pennsylvania)

(Evelyn Pringle is a columnist for Scoop Independent News and an investigative journalist focused on exposing corruption in government and corporate America)

[P.S. “Just Say No” means “contact your Senator and Represetative in Congress and tell them to vote No!”]