Thursday, September 28, 2006

Drug firms' lobby tactics revealed



http://www.guardian.co.uk/frontpage/story/0,,1882646,00.html
Drug firms' lobby tactics revealed

Documents show how companies try to get new medicines fast-tracked

Rob Evans and Sarah Boseley
Thursday September 28, 2006

Guardian

Multinational drug companies have been lobbying ministers in an attempt to subvert the independent appraisal process and get their expensive new medicines approved for large-scale use in the NHS, the Guardian can reveal.

Over the eight months from October to May this year, senior executives from 10 drug companies met ministers to press for favourable decisions on their products. The executives were highly critical of the National Institute for Clinical Excellence (Nice), an independent expert body set up to decide which drugs are cost-effective for use in the NHS.

Documents obtained by the Guardian under Freedom of Information legislation reveal that:

· The world's biggest drug company, Pfizer, warned ministers that it could take its business elsewhere. "Pfizer ... noted that there is complacency in some quarters of Whitehall regarding their continued investment in the UK," the minutes of the meeting record.

Ministers later agreed to a special meeting where six companies could lobby for their drugs for Alzheimer's disease.

· Two companies lobbied ministers for wider access by patients to their drugs, both of which were later turned down by Nice on the grounds that they were not effective enough and too expensive.

The pharmaceutical industry is a major contributor to the UK economy. Its total investment in research and development was more than £3.4bn in 2004, which, a Whitehall briefing note points out, "represents around a quarter of the UK's total manufacturing industry expenditure".

Decisions by Nice, set up seven years ago, are crucial for the companies. It decides whether a drug should be universally available to patients in the NHS. Chaired by Prof Sir Michael Rawlings, Nice draws on scientific experts and consults doctors, patients, drug companies and the Department of Health. The government invariably accepts its final recommendations. Although ministers say they cannot influence Nice, the documents reveal a constant stream of high-level visitors from drug companies.

Manufacturers, led by Pfizer, have been complaining to ministers about Nice's position on their controversial Alzheimer's drugs. Originally Nice decided to allow them, then it reversed its position, saying they should be used only for a minority of patients with moderate disease.

At a meeting in October with the minister, Pfizer executives made it clear they "were unhappy with the Nice decision ... and thought their processes were flawed". They requested a special meeting with ministers where all the companies making Alzheimer's drugs could put their case.

The documents prepared by civil servants for the Pfizer meeting outline the wealth and scale of the US company, which in 2004 had revenue of $52.5bn (£28bn) and a net income of over $11bn.

But, Pfizer executives warn the minister, it could always take its business elsewhere. "Pfizer ... noted that there is complacency in some quarters of Whitehall regarding their continued investment in the UK," the minutes record. "Pfizer asked for more public support from the government for a robust pharmaceutical industry in the UK and more consultation/dialogue with the government."

The subsequent meeting with all the companies took place in December. The minister, Jane Kennedy, was confronted by eight managing directors, vice-presidents and senior executives from six drug companies. The executives lobbied hard for the Nice ruling to be overturned by the government.

A memo reports the summing-up of Johnson & Johnson's vice-president David Brickwood: "Nice should take into account what the companies see as the overwhelming views of patients, carers and clinicians on the efficacy of the drugs."

In a statement, Pfizer said it "regularly meets with key stakeholders, including government ministers, to keep them up to date with issues relating to our business". A variety of topics were discussed, it said.

"Nice and health technology assessment remains a topical issue coupled with the proposed ban on medicines for mild Alzheimer's disease. We believe this is the wrong decision and have appealed along with other manufacturers of anti-dementia medicines."

In February, Eli Lilly lobbied hard for its drug Alimta, designed to treat the asbestos-linked cancer mesothelioma. Its executives gave a presentation to Ms Kennedy, incorporating newspaper cuttings claiming that cancer victims were dying for want of the drug. The minister agreed that there should be a high-level meeting between her ministry and the Department for Work and Pensions.

But in June, Nice said there was insufficient evidence to show that Alimta was better than other cheaper treatments, recommending that the NHS should not use it. A Lilly spokesman said it was legitimate for the company to make representations to the DoH but it was not seeking to undermine Nice. "We are fully engaged and committed to the Nice process," he said

Pressure was brought to bear on ministers by another company, Johnson & Johnson, over its bone cancer drug Velcade. A briefing for Ms Kennedy before a meeting with the company's executives in November says: "Johnson & Johnson have written to the Department of Health numerous times over the past 12 months about Velcade." The company wanted its drug fast-tracked for approval by Nice.

Velcade was one of the five drugs Nice was asked by ministers to handle through its new fast-track procedure. But Nice's appraisal committee has given a preliminary opinion that it is not suitable for use in the NHS.

A Johnson and Johnson spokesman said the company was not trying to "unduly influence" Nice but it was legitimate to seek to persuade ministers to speed up the appraisal of Velcade. The company did not want to comment on its lobbying over Alzheimer's drugs.

In May, the health minister Andy Burnham met Peter Dolan, then chief executive of Bristol-Myers Squibb and chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA), the powerful industry body in the US, which has been highly critical of Nice.

Richard Marsh, director of external affairs at Bristol-Myers Squibb, who also attended the meeting, told the Guardian that his company had wanted to raise a number of issues, including Nice, with the minister.

"Companies have a legitimate interest in getting the best for their products and getting a positive appraisal by Nice. Where they have an opportunity to raise issues with ministers, they can do that ... It may be that Nice has genuinely got a blind spot about something and a legitimate point can be made to ministers. I don't think the Nice process is necessarily undermined. It is up to the minister what they do with that information." He added that companies wanted to invest in countries with a "favourable environment".

Guardian Unlimited © Guardian Newspapers Limited 2006

Long-term Testing Requirement for Psychiatric Drugs Abandoned Due to Big Pharma Pressure on the FDA

http://www.newstarget.com/z015406.html
Long-term Testing Requirement for Psychiatric Drugs Abandoned Due to Big Pharma Pressure on the FDA

NewsTarget.com
Originally published December 4 2005

Long-term testing requirement for psychiatric drugs abandoned due to Big
Pharma pressure on the FDA

The bipolar medication lithium is so toxic that it often causes major kidney
damage, yet most patients must use it for lifetime maintenance of
manic-depressive disorder. Similarly, schizophrenics often spend lifetimes
on neuroleptics with long-term side effects such as tardive dyskinesias, or
uncontrollable movement of the face, tongue, lips and extremities.

The point here? Side effects almost always go hand-in-hand with taking a
medication for a long duration in order to treat a chronic condition. With
that in mind, it seems outrageous that on Oct. 25, 2005, a panel voted to
defeat the FDA's proposal to extend pre-approval testing of psychiatric
drugs from two short-term studies to six-month trials. In layman's terms,
psychiatric drugs will not be tested for a long enough time to determine
their safety for long-term use before they are approved. Now, they can be
tested for as little as two weeks, then given the stamp of safety approval
by the FDA after which they will be used for years, if not decades, on
unsuspecting patients.

In a Sept. 26 memo, Dr. Thomas P. Laughren, acting director of the FDA's
Division of Psychiatry Products, gave solid reasons for the FDA's desire to
extend its required testing time. In fact, he begins the memo with a simple
fact that makes the need for long-term testing clear: "Most psychiatric
illnesses are chronic." He later goes on to explain that current short-term
testing methods advocate stopping treatment of subjects who are responding
to the drug after only a few weeks, something that would be considered
"ethically questionable" in actual clinical treatment. In other words,
real-world patients with mental disorders may have to stay on these drugs
for months, years, decades and possibly even a lifetime, so why should
clinical testing be limited to the short term?

The current short-term tests also present a problem for psychiatrists who
are prescribing a newly-approved drug. As Dr. Laughren explains, "Since most
treatment guidelines for chronic psychiatric illnesses recommend continuing
patients for four to six months or longer after response during short-term
treatment, clinicians have generally not had a sufficient evidence base
(from pre-approval studies) to support what is the standard practice of drug
treatment of psychiatric illnesses."

When a psychiatric drug first hits the market, prescribing physicians are
largely left in the dark about treatment issues after a patient stays on the
medication longer than the six to 12 weeks tested during approval trials.
Yes, the FDA generally asks for longer-term studies to be completed after
approval, but it can be years before this is done. During this time patients
are put at risk for side effects that did not emerge in the short
pre-approval studies.

How Big Pharma overrules the FDA

Though Dr. Laughren rightly petitioned for testing standards to change, Big
Pharma once again flexed its muscles and defeated the FDA's acting director
and other supporters of longer safety testing requirements. Pharmaceutical
industry executives from Merck, Wyeth and Eli Lilly gathered with academic
researchers and presented the 11-member Psychopharmacological Drugs Advisory
Committee with 15 presentations, all against extending the duration of
pre-approval trials to six months.

Their argument? According to Eli Lilly's David Michelson, executive director
for neuroscience medical research, half of all patients switch psychiatric
medications after three months of treatment, with the figure reaching as
high as 70 percent after six months. According to this logic, conducting
six-month pre-approval tests will not benefit enough psychiatric patients to
warrant the policy change. In other words, Big Pharma is saying we should
ignore the potential health risks posed to psychiatric patients who take
these drugs on a long-term basis because they don't make up a large consumer
group. This perspective is alarming in itself, but given the scandals
surrounding Vioxx and other prescription drugs, it comes as no surprise.
The facts are clear: Mental illness is presently an epidemic in modern
society, a result of our chronic malnutrition and ingestion of metabolic
disruptors (ingredients that disrupt normal brain function, such as refined
sugars, trans fatty acids, chemical sweeteners, artificial colors, etc.).
According to statistics from the National Institute of Mental Health, about
one in five American adults suffer from a diagnosable mental illness.
To make matters worse, our population's desire for "magic pill" solutions
has made us look to chemical cures for nutritionally- and
environmentally-based problems. Because of this trend, drugs that we don't
fully understand are being prescribed to an ever-increasing percentage of
our population. The long-term effects of this could be disastrous.
In this case, the FDA tried to take a positive step in protecting the
public, but failed under the pressure from Big Pharma. It's now up to
concerned consumers like you to make your voice heard. Tell the FDA that you
want psychiatric medication adequately tested, no matter what Big Pharma
says.

Works cited:
FDA Advisory Committee. "Committee Information: Psychopharmacologic Drugs
Advisory Committee."
2005. http://fdaadvisorycommittee.com
Laughren, Thomas P., M.D. "Memorandum to Members, PDAC."
26 Sept. 2005.
http://www.fda.gov
National Institute of Mental Health.
"Statistics." 15 Sept. 2005.
http://www.nimh.nih.gov
Vedantam, Shankar. "U.S. Alters Test Policy on Psychiatric Drugs."
Washington Post. 26 Oct. 2005. http://www.washingtonpost.com

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content. Truth Publishing sells no hard products and earns no money from the
recommendation of products. Newstarget.com is presented for educational and
commentary purposes only and should not be construed as professional advice
from any licensed practitioner. It is not intended as a substitute for the
diagnosis, treatment or advice of a qualified professional. Truth Publishing
assumes no responsibility for the use or misuse of this material.

A Prescription For Disaster

Word continues to spread throughout the USA. How fast it spreads depends on how hard you push this: http://www.petitiononline.com/TScreen/petition.html

http://www.michnews.com/artman/publish/article_14240.shtml


Guest Commentary
TeenScreen Suicide Survey - A Prescription For Disaster
By C. J. Williams
MichNews.com
Sep 28, 2006

In his 1972 keynote address to the Association for Childhood Education International, Dr. Chester M. Pierce said, “Every child in America entering school at the age of five is insane because he comes to school with certain allegiances toward our founding fathers, toward his parents, toward a belief in a supernatural being…It’s up to you, teachers, to make all of these sick children well by creating the international children of the future.”

Pierce has been a World Association of Social Psychiatry board member, as well as a board member of local and national voluntary organizations concerned with youth, human rights, and conservation.

Yes, conservation, but then “international children” are being taught to conform to United Nations Agenda 21 mandates, which include allegiance to global dictates and not Constitutional rights, allegiance to peer groups and not individual families, and a worshipful allegiance to Mother Nature, not God.

The Fascists overtaking our country are targeting our nation’s youth, finding ways to make children conform even if it means labeling them as mentally ill and drugging them to do it.

In fact, a National Training Labs, Institute for Applied Behavioral Science Teacher Training Manual states that “Although they (nonconforming students) appear to behave appropriately and seem normal by most cultural standards, they may actually be in need of mental health care in order to help change, adapt, and conform to the planned society in which there will be no conflict of attitudes or beliefs.”

Although several mental health-screening programs are finding their way into our schools, “TeenScreen” has been drawing lots of negative attention. Actually, TeenScreen is so controversial that it won’t divulge names of school districts using its program in states that have welcomed “universal mental health screening” by accepting federal grants that help fund it. “Universal” means “entire”, “total”, “everyone”, and Michigan appears to have welcomed it, as has Wisconsin and several other neighboring states.

A group of well-organized parents and other concerned citizens, working under the name “TeenScreen Truth”, has dedicated itself to ferreting out school districts using the deceptive TeenScreen program. When they learn where it’s operating, they do anything within their power to get the word out to that community’s parents.

However, many children are victimized before an alarm is sounded because the program is being covertly operated in schools. A link to a Website map of known school districts subjecting children to the screening is provided below.

The reasoning behind the secrecy, according to TeenScreen’s director, Leslie McGuire, is because they fear there’ll be an uprising against their program at these locations. Those who take the time to research it will understand why.

Parents who hear of it already in or coming to their community are encouraged to visit TeenScreen Truth’s Website and report the information. (First link below)

TeenScreen’s program, developed at Columbia University, is presented to schools as a so-called “diagnostic psychiatric service” that conducts computerized surveys to determine which children have mental disorders.

When found to be mentally unwell, as a great many are because of the asinine questions asked, children are labeled with any variety of psychiatric disorder and told to have their parents follow up with a “clinician”.

Being labeled with a mental disorder creates a great deal of anguish for kids, but worse are the psychotropic drugs prescribed to treat a disorder in spite of the fact that many of these drugs are known to cause violence and suicide. At least eight of the last 13 school shootings were committed by teens taking prescribed psychotropic drugs, including 16-year-old Jeff Weise who killed nine persons and himself in Red Lake, Minnesota.

Regardless of the danger these drugs pose to children, they mean millions of dollars for big pharmaceutical companies that promote universal mental health screening by funding it, not just for all K-12 students, but for infants, toddlers, pre-schoolers, and new mothers, too.

TeenScreen’s goal is to survey every child in America, and they’re doing it out of sight, behind closed schoolhouse doors. They even offer enticements such as free movie passes and food coupons to kids who take the consent form home and bring it back. But many forms don’t make it home or back to school, and sometimes kids who want the freebies sign the form themselves.

TeenScreen uses what’s known as a “passive consent form”, which means if parents don’t respond, silence becomes the voice of consent. TeenScreen prefers this because it boosts their success rate. Think of that the next time Johnnie forgets to bring school notices home or you’re too busy to look at them if he does.

Some survey questions asked are: “Have you often worried a lot before you were going to play a sport or game or do some sort of other activity? Has there been a time when you had less energy than you usually do? Have you often felt very nervous when you’ve had to do things in front of people? Has there been a time when nothing was fun for you and you just weren’t interested in anything? If those questions are indicative of a psychiatric disorder, then many of us have been raving lunatics for years.

The last link below pertains to a lawsuit initiated by Mike and Teresa Rhoades of Indiana whose daughter, Chelsea, took the computerized TeenScreen survey at age 15 without them knowing about it. You’ll find the survey in section 31.4 and Chelsea’s disturbing statement in 31.5.

According to a May 2006 National Journal report by Neil Munro, Chelsea was told at school that she’d been diagnosed with “social anxiety disorder” and “obsessive-compulsive disorder”. She was advised to have her parents take her to the local mental health clinic whose employees had administered the TeenScreen survey.

In tears, she asked her parents about the diagnosis. Surprised and angry, her parents discovered that because Chelsea wasn’t allowed to go out on school nights, she’d answered “yes” to the question asking if she felt cut off from friends; this resulted in the social anxiety disorder label. Chelsea was diagnosed as obsessive-compulsive because she’d answered, yes, she found herself repeatedly doing something she had little or no control over. The “something” turned out to be cleaning her room and doing daily chores around the house.

Obviously, whoever labeled this girl with two psychiatric disorders didn’t bother to follow-up on why she replied as she did before they destroyed her sense of self and sent her back to classes for the rest of the day.

Parents and concerned citizens are advised to e-mail or write to their school board and/or district superintendent (keep it in writing) and ask if TeenScreen or any other mental health screening has been implemented in the school district or if there are plans to do so in the future. If the answer is yes, they’re advised to alert other parents and, above all, voice their opposition.

If TeenScreen is in your school or coming there, please let TeenScreen Truth know by visiting their site. Your information will be verified and sent on to the TeenScreen location Website so their map can be updated. Parents are also advised to file a “parental informed consent notice” with their child’s school, which should protect children in the event of any sort of survey. You have a right to do so – exercise it. A sample notice is available at TeenScreen Truth’s Website on the “What You Can Do” page.

There are federal and state laws requiring “informed consent”, meaning that before someone agrees to participate in any medical procedure or experiment, they must be informed of and must understand the medical facts and risks involved. TeenScreen ignores those laws.

“Fully informed consent” for TeenScreen would be consent given only after having received and understood all pertinent data involved. This includes, among other things, knowing that Psychiatry’s “Diagnostic Statistical Manual” has over 300 behaviors that have just been voted on, according to whim, not tests or real facts, and that parents may lose their parental rights or even be criminally charged with neglect if they refuse to accept TeenScreen’s diagnosis and see to it that their child receives psychiatric treatment.

Copyright by C. J. Williams

http://www.teenscreentruth.com

http://www.teenscreen-locations.com/index.htm

http://www.petitiononline.com/TScreen/petition.html

http://www.crossroad.to/text/articles/tnmfobe1196.html

http://www.crossroad.to/Books/BraveNewSchools/2-International.htm

http://www.edwatch.org/updates06/061906-fedmhs.htm

http://www.psychsearch.net/teenscreen.html

http://www.psychsearch.net/teenscreen_lawsuit.html

++
To submit feedback: michnews (at) michnews.com

Monday, September 25, 2006

Report urges review of drugs

http://vancouver.24hrs.ca/News/2006/09/21/1872508-sun.html

September 21, 2006

Report urges review of drugs
By IRWIN LOY, 24 HOURS

The B.C. government is being urged to look at how prescription drugs are given to children in government care, after a new report revealed kids in care are up to 12 times more likely to be prescribed stimulant drugs like Ritalin.

A joint special report from B.C.'s child and youth officer and the provincial health officer showed children in care are prescribed mental-health drugs at significantly higher rates than those in the general population. Kids in care, for example, receive Ritalin-type prescriptions at a rate 8.5 to 12 times higher.

"It does raise a concern when 10 times as many children in care are being prescribed these medications," child and youth officer Jane Morley told 24 hours in an interview yesterday. "... There's some research that suggests that [Ritalin-type drugs] could have secondary effects that aren't good, and also we don't know for sure how effective it is."

Morley said the Ministry of Children, as the "responsible parent" for children in its care, should consult with B.C.'s College of Physicians and Surgeons to determine if kids in care are being over- prescribed.

It may turn out, said Morley, that prescription rates are fine as they are. "It's not that we're saying it's necessarily wrong, but we've got to be cautious about it."

A 2000 review by the College found the province had a five-fold increase in Ritalin use, mainly due to more frequent diagnoses of attention-deficit and hyperactivity disorder. It concluded Ritalin was being prescribed responsibly.

Morley's report also showed that compared to the general population, kids in government care had higher rates of death and injury, depression, early pregnancy, and were also four times as likely to be diagnosed with a mental disorder.

YOU SHOULD KNOW

- 9,083 children in care.

- 49% are aboriginal (General population: 7%).

- 65% in continuing care diagnosed with mental disorder (four times that of general population).

Prescription drug abuse up among students, survey says

No surprise

Prescription drug abuse up among students, survey says

Monday, September 25, 2006

Pot, alcohol, steroids, cigarettes, meth, ecstasy and LSD are being used less and less by American teenagers since the 1990s when such abuse problems peaked.

But in the same period that street drugs have become less popular with youngsters, misuse of prescription drugs has been on the rise, according to the National Institute of Drug Abuse, which has surveyed youngsters across the country since 1975.

“I think a lot of young people believe that they are somehow safe because they are prescribed by physicians,” said Lloyd Johnston, a professor at the University of Michigan’s Institute of Social Research. “But without the active management of a physician, usually in cases where they are being given for pain control, they can be very dangerous.”

Johnston oversaw the National Institute on Drug Abuse’s latest “Monitoring the Future” survey.

The latest survey showed that abuse of OxyContin and Vicodin, both prescription painkillers, continued at levels that have experts in Lawrence and nationally concerned.

In 2005, 9.5 percent of high school seniors admitted abuse of Vicodin, ranking it among the most commonly abused drugs.

Local problem

Investigations are under way in schools in Baldwin and Tonganoxie, where students allegedly used and distributed prescription drugs.

At Baldwin High School, there was alleged use of illegally obtained prescription drugs by students, according to Baldwin Police Chief Mike McKenna.

In Tonganoxie, Police Lt. Billy Adcox said it was believed two male ninth-graders distributed between 50 and 150 hydrocodone pills, also known as Vicodin or Lortab. The prescription for the drug had been written for one of the students’ relatives.

And in Lawrence, though there have been no recent arrests, students say abuse is a reality.

“It does happen,” said Taylor Renfro, a Lawrence High School senior. “I wouldn’t consider it a huge problem, but it does happen.”

Kristin Penny, also a LHS senior, said she’d heard fellow students talk of using prescription drugs to get high, but that the abuse is generally private.

“It’s a personal deal,” Penny said. “They take them on their own time.”

Zack Johnson, a Free State High School senior, said some prescription drugs he had heard students were abusing included hydrocodone and Adderall and Ritalin, two drugs used to treat attention-deficit hyperactivity disorder.

Pain-free society?

Paula Hatcher, school nurse at Free State, said she hasn’t dealt with any prescription drug cases at school but thinks such abuse is “becoming a problem” among teens.

“I’ve been reading more and more about it in nursing journals,” she said. “I think we live in a society where people want to be cured instantly. So every time they have a pain, they want a prescription. So maybe they are more readily available.”

Charlie Kuszmaul said it was little surprise that young people would turn to prescription drugs, given their prevalence and relatively easy availability.

Kuszmaul directs the Bert Nash Community Mental Health Center’s Working to Recognize Alternative Possibilities school program. He said prescription drugs are widely advertised on television, building awareness.

“People will go to pretty great extremes, particularly young people, to get a high,” he said.

Patrick Parker, director of pharmacy and intravenous therapies at Lawrence Memorial Hospital, said taking a large dose of Vicodin would make a person drowsy and less inhibited.

An even larger dose, he said, could lead to sedation, respiratory problems and possible death.

He said his biggest fear is the effects that large doses of acetaminophen, a component in drugs such as Vicodin, can have on the liver.

“Tylenol (which contains acetaminophen) is a pretty safe drug when taken in normal low-dose use but can be very dangerous in high levels,” he said. “It can cause permanent liver damage, which is a real problem.”

He said pain medications are safe when taken as directed but can be dangerous if abused.

“They can be addictive,” he said. “To get the desired effect, it will take a progressively larger and larger dose.”

Past problems

Two LHS administrators said they occasionally had dealt with prescription drug busts at the school.

“It’s happened here as well, unfortunately,” LHS Principal Steve Nilhas said. “We haven’t had any incidents that we know of this year, but that doesn’t mean it can’t happen. Certainly we try to be on top of it and be as proactive as we can about it.”

Matt Brungardt, LHS associate principal, said an arrest last year at the school involved a student who traded one of his prescription pills for a cigarette. The drug was thought to have been Adderall, an amphetamine used for ADHD.

Free State Principal Joe Snyder said he couldn’t recall an incident involving prescription drug abuse at the school, though there have been problems with alcohol and marijuana.

But Hatcher, the Free State nurse, said parents should “never assume that their child won’t be the one.”

She advises parents to keep prescription drugs locked up, count what they have and talk with their children about abuse concerns.

A key sign a child might be abusing drugs would be withdrawal from normal activities, she said.

“If they aren’t engaging in activities that they were doing before, they might be filling that time with a new activity,” Hatcher said. “Drugs become their new activity.

400,000 children are given 'good behaviour' drug

The horror...

http://www.telegraph.co.uk/health/main.jhtml?view=DETAILS&grid=&xml=/health/2006/09/25/nkids23.xml

400,000 children are given 'good behaviour' drug

(Filed: 25/09/2006)

  • Your view: Daily Telegraph campaign to halt 'death of childhood'

    Zac Goldsmith, one of David Cameron's key policy advisers, yesterday backed the Hold on to Childhood coverage in The Daily Telegraph and said he was worried at the ease with which doctors prescribed pills to tackle children's emotional upsets.

    The multi-millionaire environmental campaigner said that a proper investigation would "almost certainly" reveal a link between pollutants in children's food and the surge in childhood depression and behavioural problems.

    Mr Goldsmith, who is deputy chairman of the Conservatives' quality of life policy group and editor of the Ecologist, said it was up to the medical profession to find out why there had been a huge increase in the diagnosis of psychological disorders in children in recent years, and not just to "patch it up with drugs".

    On Monday his magazine will publish a detailed report into the crisis of British childhood, echoing many of the themes of Hold on to Childhood, which was itself sparked by a letter from 110 children's experts, authors and doctors.

    The Ecologist article, written by Rachel Ragg, a former Leeds University lecturer and mother of two, points out that almost 400,000 children were last year prescribed Ritalin, a drug almost unknown in Britain in the early 1990s.

    It argues that this is symptomatic of a sudden and dangerous crisis facing our next generation. Mrs Ragg said: "Childhood is no longer childhood for the vast majority of children and I think this Government has been absolutely appalling to children.

    "They have provided financial incentives to parents to go back to work, and pressurised them to send children to nurseries by implying that their children will be economically, academically and culturally disadvantaged if they aren't in a nursery by the age of two. In fact, all evidence suggests this is the reverse of the truth.

    "It may very well be that ADHD [attention deficit hyperactivity disorder] stems from a culture in which young children are stuck in nurseries listening to lectures about diversity when they should be out splashing in puddles and climbing trees."

    Mr Goldsmith said yesterday: "The Telegraph's campaign to reclaim childhood for the next generation is one I wholly support.

    "We've arrived at a point where childhood, and all things that go with it, are inconvenient, with the natural impulses of children increasingly diagnosed as inappropriate once they enter a nursery or school environment."

    He added that he thought the NHS should stop relying on the diagnosis of conditions such as ADHD, which usually led to the prescription of drugs such as Ritalin.

    "It's worrying that the medical establishment's default response to behavioural difficulties is to reach for pills. Something is obviously triggering an increase in their use and the first role of the health service should be to identify what that is.

    "If a real investigation took place we'd almost certainly discover problems with the food children are eating. But we'd also have to confront the fact that despite unprecedented material wealth, children aren't thriving."

    bfenton (at) telegraph.co.uk

  • Friday, September 22, 2006

    Six-fold increase called worrisome because research is scant on medicines' effects on children

    "It sailed through the Indiana General Assembly with only one dissent in 2005, but in the past few weeks Senate Enrolled Act 529 and portions of it have received national attention.

    ... the section that is drawing the ire of conservatives, civil rights proponents and even some of the legislators who passed the law, is the section directing the DOE (Department of Education) to ...develop and coordinate a children’s social, emotional and behavioral health plan". [mental illness screening]


    Some legislators are now talking about repealing the law.


    fwdailynews.com (Fort Wayne, Indiana)

    Below are comments from FWDailyNews.com readers regarding this series. Feel free to add your own thoughts about SEA 529: http://www.kpcnews.com/online_features/sea529/comments/comments.txt

    James R Speiser, VMD wrote on September 21, 2006 10:46 AM:"I am a doctor and a parent. I am appalled at the idea of lawmakers instituting a "screen" for mental illness in children. This is the most outrageous idea possible. It is assured that the Psychs will be able to justify a diagnosis from the DSM, all of which are fabricated diseases in the 1st place. This law MUST BE REPEALED before the entire future of the planet (children) are drugged into a state of robotic calm....that apparently is considered a "normal" state of being. Let children be children and get the psychs out of the schools. "

    Chantal Valtin wrote on September 21, 2006 7:45 AM:"Thank you for the article entitled "Children's Mental Health Discussion Must Begin" of Sunday Sept 17. We need to let people know how dangerous it is to let all kids (and they even talk about infants & toddlers now!!) be screened for "potential" mental disorder or suicidal thoughts. This is just another way of being able to sell more drugs and make people more docile, killing all creativity these kids have. I invite you to have a look at www.resultsproject.net and see how you can shift your point of view on this ADD problem. I want also to point out that Indiana Gov. Mitch Danielsm who signed the Indiana law was the former president of Eli Lilly... any link here? Thank you for the controversy... and keep fighting for our rights!"

    Ernest Ryan wrote on September 20, 2006 10:13 PM:"Here is an example of what Indiana families can expect to see happen if they do not take immediate action to repeal SEA 529. This bill mandates universal mental health testing for Indiana children. As a result of this, all school children will take some form of invasive mental health survey such as the TeenScreen survey that was recently run on a pilot group of 71 Mansfield, Ohio area ninth-graders. Based on the results of that screening "39 students required a follow-up interview with a clinician." That's 55% of what would otherwise be considered normal students now needing to see a mental health clinician based on answers they gave to the TeenScreen survey. That's quite a few kids that might end up spending years taking drugs like Prozac, Strattera, Cymbalta or Zyprexa. These are all expensive and often violence and suicide-inducing psychiatric drugs made by Eli Lilly. The fact that Gov. Mitch Daniels was the former President of Eli Lilly is one big reason SEA 529 got signed into law. I wonder how much the Indiana Commission on Mental Health had to do with designing this ground-breaking mental health plan for Indiana school children. Just when the light of public outrage started shining on mandated mental health screening in Indiana, Robert Postlethwait, a member of that commission, quietly resigned. He was also a 30-year employee of Eli Lilly and an advisor to TeenScreen which figures prominently in surveying children for mental illness in many American schools and funneling them to psychiatrists who put them on psychiatric medications in almost every case. It seems to me that Robert Postlethwait should become a person of interest. With Eli Lilly being centered in Indianapolis, is it any wonder why Indiana school children are being set up to be prescribed the profitable psychiatric drugs that they make? With the help of TeenScreen, the Madison Center in South Bend, Indiana, is now treating over 500 kids per day for trumped up mental illnesses and they recently broke ground on an expansion building so they can treat many more kids. This was all reported in the South Bend Tribune in September, 2005. People need to question how SEA 529 came about and investigate the connections and backgrounds of everyone connected to bringing that law into existence. Then repeal SEA 529 and prosecute those found promoting the interests of Eli Lilly and other drug companies at the expense of Indiana's children and families. This whole issue is not about the welfare of children at all. It is about ruthless greed, money and hooking kids on profitable psychiatric drugs and nothing else. "

    James Rugg, CARE representative (Citizen Awareness of the Restructuring of Education), St. Cloud, MN wrote on September 20, 2006 1:55 PM:"Thank you for your work on and interest in the mental health debacle surfacing country wide. This is indeed an invasion of personal rights as well as a further removal of parental responsibility in the control of their children. All the federal government has to do is promote some issue, tag millions of dollars to it to get it going, and representatives in state legislatures fall all over themselves to get in on the monies. If you haven't noticed already, there has been an effort in K-12 schools to enhance the psychiatric industries position in student issues. In MN, some screening was done before legislation was even introduced. It was kept on the quiet and justified by some obscure older rule. I refer you to the work of Dr. Karen Effrem who has done extensive study and reporting on the subject of mental health screening. Her work can be found at www.EdWatch.org . Keep on this. It is critical."

    Garrison Clarke, Altadena, CA wrote on September 20, 2006 8:48 AM:"Physical and mental are different. One deals with the body and the other with the mind. The mind is not a physical thing. You can't touch the mind or hold it in your hand. The brain is not a mind. Each person has his own mind and it is uniquely his. When a government wants to manipulate a mind you have something other than a government. When a Board of Education wants to manipulate a mind you have something other than an educational body. It is one thing to have an opinion about how a person is. It is another thing to try to mold them into what you want them to be. Each person is an individual. That is the way it is. Lab rats are never going to provide insight into the mind of a human being. Where there is no understanding there will be no improvement. This is simple common sense. Repeal SEA 529 Psychiatrists are pseudo scientists who position themselves as being like medical practitioners. They hope to gain credibility. Their marketing apparatus will give a list of physical problems the schools "screen" for. Among physical problems are sandwiched psychiatrists invented names. The list sounds like, "cancer, tumor, math disorder, broken bones, etc". The only "treatment" for a psychiatrists "illness" is a pharmaceutical poison. The pseudo scientist can't cure a thing and he will tell he can't if you ask him. Repeal SEA 529 The Indiana state government is headed up by Eli Lilly's former president. The people involved here have pharmaceutical ties form top to bottom. There is not one shred of evidence that a pharmaceutical/psychiatric approach to child care has done anything but harm children. Repeal SEA 529 TeenScreen is a fraud. They tell us teen suicide is the third leading cause of death among kids 15-19 years old. They say 1,700 kids kill themselves each year. It is impossible to find these in a population of over 34,000,000 kids. That is a .00005 percentage of suicidal kids you├»¿½d have to locate each year. At least half of the kids who kill themselves are taking the psychotropic drugs the FDA warns cause suicidal behavior. If you really want to prevent suicide get these kids off of the drugs. Repeal SEA 529"

    Tony Miller, Fresno, Ca. wrote on September 20, 2006 8:37 AM:" If ever there was a time for a hard hitting investigative reporter...now is that time. When I was 14 my dad killed himself. My mother developed mental problems trying to deal with it. I was left 'man of the house' in my dad's suicide note. In other words, I was left to handle all the problems. I did everything I could to fulfill that assignment. I just want you to know my sincerity and motivation for writing. I am now 60 and have lived a wonderful life as have my children and grandchildren. Few have studied as long and hard as I have to understand suicide and mental stress. I have reached some objective conclusions. Psychiatry is NOT the solution but the biggest problem. When I was 21 I took my mother to a psychiatrist. That is when her real problems began. They put her on psychotropic drugs. She went downhill fast and became violent and suicidal. Finally, a real physician came to the rescue and put her on a plan to eliminate the psych drugs and put her on a strict diet and demanded family members take her for walks and get her out of the house. He pulled me aside and said " I wouldn't take a dog to a psychiatrist. I have seen this my entire career but looked the other way for fear of being blackballed. I am ashamed of my cowardess.I retire this year so I no longer care about what they can do." I started feverishly studying to prove that real doctor wrong and justify my decision to seek psychiatric 'help' for my mom. I studied a LOT. I finally came to the honest realization that I had fell for the very sophisticated manipulation techniques developed by Sigmund Freud's nephew, Edward Bernays. Nothing has permeated our society more than these 'public relations and propaganda techniques'. They started with the tobacco industry and now psychiatry and the pharmaceutical industry have joined forces in the most lucrative financial endeavor ever dreamed of. The only problem is that more people will die and more lives will be ruined than any scenario envisioned by anti-tobacco lobby. I beseech you once again...please do thorough research and ask hard hitting questions of the psychiatrists as though children's lives may depend on it, because they do. I have a lot of investigative material by the worlds top objective authorities stored on my computer if you need it I will send it. "

    Tom Beattie, Enola, Pa. wrote on September 20, 2006 8:26 AM:"I applaud FWdailynews.com for being concerned about the out of control "mental health" community and its reach into our kids lives. I am sure many of your readers are aware that Senate Enrolled Act 529 is all about treatment, and that treatment is with "drugs". I am also sure your readers are aware that Gov Mitch Daniels is also a past president of Eli Lilly Co. Do I hear conflict of interest? How many commission members who are implementing this program are employed by Lilly or are psychologists and would stand to monetarily benefit from it's implementation? SEA 529 sounds like it passed like the Patriot Act did with a "just vote yes for it as it is groundbreaking legislation for our children's mental health and their bright futures". Who would argue if today's so called mental health professionals could actually cure the bogus bipolar disorder, but all the psychiatrists do is prescribe Lilly's prozac or SmithKline's Paxil which are not cures, only expensive highs and big big letdowns with toxic and deadly side effects. For the sake of Indiana's future, Repeal the SEA! Our kids do not need the state or the feds deciding our kids mental health. Kick Big Brother OUT!"

    Pearl Lantz wrote on September 19, 2006 4:30 PM:"Thank you for your excellent article regarding SEA 529. As is obvious, this has opened up a can of worms which the government has no business in. This smacks of Big Brother, deciding which of our children needs conforming to the "norm." Who decides on what is normal? The psychiatrist? The person with vested interests in drugging everyone and making tons of profit from it? I think not! This bill needs to be repealed to send a message to all of the states that the government and the drug companies have no business in running our lives and that of our children. As a further note, the money ties are so very obvious. Were you aware that Indiana Gov. Mitch Daniels, who signed the Indiana law, was the former President of Eli Lilly? Indianapolis is the home office for Eli Lilly. Are any of the Commission members employed by pharmaceutical companies? I smell a rat. Please use your investigative reporting skills and weed this one out."

    Doris Bentz wrote on September 19, 2006 4:19 PM:"We must not let pharmaceutical companies nor the psychs get away with drugging our children and enslave our future generations. We must stop them. WE must enforce our human rights and let the people of this wonderful country know what they're up against. NO to Teen Screen! No to legislators that have ties to the pharmaceutical companies! This is serious business, it is the future of our country. Let's preserve our freedom!!"

    Ole Thiemer, Copenhagen wrote on September 19, 2006 4:19 PM:"I saw your article in the newspaper and even I'm not a US citizens I am worried. Because if the state first are allowed to take away parents rights I see the future as some of the worse movies I have seen about the future, where man are slaves of the few. The point is that I have seen a lot of evidence that many, many of the mental illnesses isn't illnesses but a mocked up thing to provide money for the few (The drug companies). This I even have on a CD-ROM where several psychiatrists admit that there isn't any evidence and there isn't any cure. If you are interested I will be happy to send you a link so you can see for your self."

    John Marty, Kendallville wrote on September 19, 2006 3:05 PM:"I wanted to let you know I think you did a whale of a job on the article you had in the Sunday Sept 17, 2006 News Sun on the Mental Health Bill SEA 529. Even though I have never been married and not a father of any kids (I don't expect either of these things to happen for me before my days are done here on earth) I support parents' rights to raise their children the way the parents see fit not the way government per se tells parents what they can and cannot do. I would like to know and would please find out how the following Indiana legislators voted on this Bill: State Senators Bob Meeks and Dennis Kruse. House representives Marlin Stutzman, Matt Bell and Dick Dodge. If you can find out who all the legislators were that voted for this bill. I want this bill SEA 529 totallly repealed just like I want the "Daylight Savings Time" Bill totally repealed. Government per se has gotten entirely too big for its britches and now this country is becoming a "Dictatorship." We citizens are no longer free to make our own decisions on almost everything. I did not like the Toll Road Bill either and I feel anyone in the Indiana legislature who voted for that Toll Road Bill as well as the Daylight Savings Time bill should be removed from Office Immediately and never allowed to run even for the office of "Fly Catcher " if there were such an office. This includes our current Governor Mr Yo-Yo Daniels. Please try and find out and let me and others know who voted for the bill SEA 529. Good job you did on the legislation bill SEA 529."

    Mary Hilton, Pinellas County, FL wrote on September 19, 2006 2:40 PM:"Parents and citizens of Indiana and Ohio need to fully inform themselves on the bed of worms which is "mental health" screening, when they do this, they will refuse to consent to such idiocy. Parents and citizens need to promote that schools do their job, and only their job, which is teaching, get it, T E A C H I N G! Students do well when they are competently taught, so that they are learning. When information is presented in an interesting and relavent way, students learn and when they are learning worthwhile data their morale is in good shape. Parents and citizens need to know that there is real help for students, and everyone for that matter who are suffering life's stresses and traumas. Real help is available from dieticians, nutritionists, PE teachers and coaches, music teachers, chiropractors, ministers, medical doctors for diagnosing medical conditions for which there is scientific, verifiable proof and other non psychiatric experts. My county's school board voted not to use TeenScreen when they fully informed themselves."

    James and Lorraine Wright wrote on September 19, 2006 2:39 PM:"Thank you for your investigation into the mental health screening of our children in our public schools. As parents we are outraged at the very idea of this program and we feel that instead of helping our children, it will actually cause great harm to them. There are so many flaws and so much vested interest in this undertaking that we are disgusted at our officials and their inept handling of this most vital decision. Again, we thank you. "
    Drug the kids and shut 'em up. Horrible.

    Report questions treatment of kids in B.C.'s care

    CanWest News Service; Victoria Times Colonist


    Thursday, September 21, 2006

    VICTORIA - Children in the continuing care of the British Columbia government are four times more likely to be treated for a mental disorder, a joint report by B.C.'s chief medical and children's officers shows.

    These children have been prescribed Ritalin-type medications between 8.5 and 12.5 times more often than children who have never been in care, says the report released Wednesday at the legislature.

    Co-authored by B.C.'s chief medical officer Perry Kendall and Child and Youth Officer Jane Morley, the report offers the first "baseline" data reflecting the health and well-being of children in government care. The data was gathered for children in care between 1997 and 2005, and the picture is not a positive one.

    Children in care were hospitalized between two and 3.5 times more frequently than those in the general population.

    Young women in continuing care became pregnant at a rate more than four times higher than those who had never been in care.

    The data also shows 85 per cent of children in continuing care received treatment for respiratory conditions before the age of 19, a rate 15 per cent higher than normal.

    As a result, the most concrete recommendation among 13 made by the officers is for the introduction of a no-smoking policy in B.C. foster homes.

    The report also recommends the Ministry of Children and Family Development engage academics to research the issue of whether children in care are being appropriately medicated with cerebral stimulants. Besides the prevalence of Ritalin use, the report shows that psychotherapeutic agents are prescribed to children in continuing care at a rate between 5.5 and eight times higher than others.

    About 65 per cent of children in continuing care receive treatment for mental disorders, four times the general population.

    Victoria Times-Colonist

    © CanWest News Service 2006
    http://www.nytimes.com/2006/09/22/business/22fdacnd.html?hp&ex=1158984000&en=0c27c1350fcf4c8b&ei=5094&partner=homepage
    September 22, 2006

    Report Lists Faults of F.D.A. Drug-Safety Process

    WASHINGTON, Sept. 22 — The nation’s system for approving and monitoring the safety of medicines is inadequate and needs far-reaching reforms, and the Food and Drug Administration is plagued with poor management and persistent internal squabbling, according to a long-anticipated study of the agency.

    The report by the Institute of Medicine is likely to intensify a debate about the safety of the nation’s drug supply and the adequacy of the F.D.A.’s oversight. The debate began in earnest in September 2004 when Merck withdrew its popular arthritis drug, Vioxx.

    The Institute of Medicine, a nonprofit organization created by Congress to advise the federal government on health issues, conducted the study at the request of the F.D.A.

    Susan Bro, an F.D.A. spokeswoman, said that the agency appreciated the work of the institute. “While we have done a lot of work over the past two years to improve the drug-safety enterprise at F.D.A., we recognize that work still remains to be done,” she said.

    Citing the Vioxx withdrawal, which happened when long-term studies revealed risks to patients five years after the drug was approved, several prominent senators have already proposed significant reforms of the F.D.A., some of which the report seems to endorse.

    The report’s conclusions are striking and often damning – particularly when discussing the agency’s Center for Drug Evaluation and Research, known as C.D.E.R.

    “Every organization has its share of dysfunctions, unhappy staff members and internal disputes, but the committee came away from various encounters with C.D.E.R staff and management with a deep concern about C.D.E.R.’s organizational health,” the report said.

    The report made these recommendations, most of which would require Congressional authorization:

    ¶ Drugs should only be approved for five-year periods so that the F.D.A. can thoroughly review post-approval safety questions.

    ¶ Newly-approved drugs should display a black triangle on their labels to warn consumers that their safety is more uncertain than that of older drugs.

    ¶ Drug advertisements should be banned during this initial period.

    ¶ The F.D.A. should be given the authority to issue fines, injunctions and withdrawals when drug makers fail -- as they often do -- to complete required safety studies.

    ¶ The F.D.A. commissioner should be appointed to a six-year term.

    The Institute described an agency split by fierce disagreements that have note been resolved by repeated reorganizations and management efforts. Indeed, managers’ failure to address such disagreements competently “has played an important role in damaging the credibility” of the F.D.A., the report said.

    Critics of the F.D.A. have long been divided into two, warring camps. Some say the agency fails to approve life-saving medicines quickly enough, while others complain that it is so intent on rapid approvals that it fails to ensure the safety of the drugs.

    The Institute’s report champions the latter view by calling for greater caution. It suggests that one of the F.D.A.’s biggest problems is a deal struck in 1992 between Congress and the drug industry in which drug makers agreed to pay millions in fees in order to speed reviews.

    This deal has increased pressures on drug reviewers to act quickly and it has limited “the ability of reviewers to examine safety signals as thoroughly as they might like,” the report said.

    “Some also have serious concerns that the regulator has been ‘captured’ by industry it regulates, that the agency is less willing to use the regulatory authority at its disposal,” the report said.

    It criticizes the agency’s regulatory tools as “all-or-nothing.”

    “The agency needs a more nuanced set of tools to signal uncertainties, to reduce advertising that drives rapid uptake of new drugs, or to compel additional studies in the actual patient populations who take the drug after its approval,” the report states.

    Couched in formal language and careful footnotes, the report’s boring exterior belies an incendiary heart. With each page, it paints a devastating picture of a dysfunctional agency that is unable to ensure the safety of the nation’s drug supply.

    The report will almost certainly bolster efforts by some in Congress to pass fundamental reforms.

    Sen. Michael B. Enzi, Republican of Wyoming and chairman of the Health, Education, Labor and Pensions Committee, and Sen. Edward M. Kennedy of Massachusetts, the ranking Democrat on the committee, have jointly proposed a bill that would undertake at least some of the reforms advocated by the report.

    Another bill sponsored by Sen. Charles Senator Charles E. Grassley, Republican of Iowa and chairman of the Senate Finance Committee, and Senator Christopher J. Dodd, Democrat of Connecticut, offers similar proposals.

    There is little chance that Congress will act on any of these proposals before next year, when it must reauthorize the 1992 funding deal with the drug industry. Negotiations between the drug industry and F.D.A. about the parameters of that deal are already under way.

    Despite its fierce criticisms, the report may bolster the confirmation prospects of Dr. Andrew von Eschenbach, who is presently the agency’s acting commissioner. A senate committee approved Dr. von Eschenbach’s nomination on Wednesday, but two Republican senators have vowed to block it.

    Over the past 10 years, no commissioner has served more than two years. The report decried this “lack of stable leadership.”

    “Without stable leadership strongly and visibly committed to drug safety, all other efforts to improve the effectiveness of the agency or position it effectively for the future will be seriously, if not fatally, compromised,” the report states.

    The report recommends that the commissioner be nominated for a six-year term, but such a change may not solve the problem of early exits. President Bush has nominated two previous commissioners. The first left for another job within the administration; the second left amid allegations of financial improprieties.

    The report recommends that Michael O. Leavitt, the secretary of health and human services, appoint an independent board to advise the agency’s commissioner “to implement and sustain the changes necessary to transform” the agency’s culture.

    The report rejects suggestions made by Mr. Grassley and others that the F.D.A. create a center for drug safety charged with monitoring the safety of drugs after approval.

    “Achieving a balanced approach to the assessment of risks and benefits would be greatly complicated, or even compromised, if two separate organizations were working in isolation from one another,” the report concludes.

    The F.D.A. asked the Institute of Medicine to review its drug safety system shortly after the Vioxx withdrawal in 2004. The agency has agreed to pay $3 million for the study.


    http://www.canada.com/reginaleaderpost/news/canada_world/story.html?id=184915db-5617-4629-9e4d-dbb1f9af2a31

    ADHD drug info revised

    Sharon Kirkey, CanWest News Service
    Published: Friday, September 22, 2006

    All drugs for attention deficit disorder may cause psychotic reactions, including rare cases of hallucinations and agitation in children, Health Canada is warning.

    In a public advisory issued Thursday, the agency said patient and labelling information for a raft of medicines prescribed for attention deficit/hyperactivity disorder, or ADHD, will be changed to reflect "the potential for psychiatric adverse events."

    The brain stimulants are among the most commonly prescribed drugs to Canadian children. More than 1.9 million prescriptions were filled by retail drugstores between September 2005 and August 2006, according to IMS Health Canada, a prescription drug tracking firm.

    Health Canada says ADHD drugs are "generally safe" and effective when used properly. "Patients taking ADHD drugs should consult with their physicians if they have any questions or concerns."

    The new safety concerns come four months after Health Canada warned ADHD drugs can carry rare heart risks, including a risk of sudden death. That public advisory cautioned that any child or adult with high blood pressure, heart disease or heart abnormalities, hardening of the arteries or an overactive thyroid gland should not use Ritalin or seven other medications.

    The new advisory applies to those same drugs: Ritalin and Ritalin SR (a slow-release version), Adderall XR, Attenade, Biphentin, Concerta, Dexedrine and Strattera.

    "We've been in discussions with the manufacturers and we expect to have the label changes made by December," Health Canada spokesman Paul Duchesne said.

    In March, a U.S. Food and Drug Administration advisory committee heard that as many as six per cent of children on ADHD drugs may be at risk of a psychiatric side effect.

    The FDA's Kate Gelperin, an expert on drug safety, described cases of "hallucinations, both visual and tactile, involving insects, snakes and worms", according to Knight-Ridder newspapers. Hallucinations have been reported in children with no identified risk factors, and at usual doses.

    A review of post-marketing safety data found a "substantial portion" occurred in children 10 or younger, age groups where hallucinations are not common.

    The FDA has received reports of manic symptoms, hallucinations and abnormal behaviour -- including one six-year-old boy who started licking the table one day after starting treatment.

    Suzanne VanAmstel, of Janssen-Ortho, makers of Concerta, would say only that the drug company is "in discussions with Health Canada regarding an update to Concerta."

    From 2000 to 2005, Health Canada received 187 suspected adverse drug reaction reports for methylphenidate, the main ingredient in Ritalin and Concerta. They included three deaths (two suicides and one sudden death), seven convulsions, eight "mood/personality/psychological" reports, and eight reports of aggressive behaviour.

    Of the 55 reports involving Stattera, 11 involved mood or psychological changes, and seven aggressive behaviours.

    There were 68 suspected adverse drug reactions for dextroamphetamine, which includes Dexedrine and Adderall. Of those, six involved mood/personality/psychological reports, two aggressive behaviour, seven tics or twitching and two movement disorders.

    No direct cause-and-effect link has been proven. The reports are based on suspicion or opinion only.

    © The Leader-Post (Regina) 2006

    Thursday, September 21, 2006

    Medicaid charged for mental health treatment of dead people.

    State would not give-up who the agencies where for 24 hours.

    http://keyetv.com/topstories/local_story_263190622.html

    More out-of-control medication...

    or

    http://tinyurl.com/qdmyp


    Report questions treatment of kids in B.C.'s care


    CanWest News Service; Victoria Times Colonist



    Thursday, September 21, 2006


    VICTORIA - Children in the continuing care of the British Columbia government are four times more likely to be treated for a mental disorder, a joint report by B.C.'s chief medical and children's officers shows.

    These children have been prescribed Ritalin-type medications between 8.5 and 12.5 times more often than children who have never been in care, says the report released Wednesday at the legislature.

    Co-authored by B.C.'s chief medical officer Perry Kendall and Child and Youth Officer Jane Morley, the report offers the first "baseline" data reflecting the health and well-being of children in government care. The data was gathered for children in care between 1997 and 2005, and the picture is not a positive one.

    Children in care were hospitalized between two and 3.5 times more frequently than those in the general population.

    Young women in continuing care became pregnant at a rate more than four times higher than those who had never been in care.

    The data also shows 85 per cent of children in continuing care received treatment for respiratory conditions before the age of 19, a rate 15 per cent higher than normal.

    As a result, the most concrete recommendation among 13 made by the officers is for the introduction of a no-smoking policy in B.C. foster homes.

    The report also recommends the Ministry of Children and Family Development engage academics to research the issue of whether children in care are being appropriately medicated with cerebral stimulants. Besides the prevalence of Ritalin use, the report shows that psychotherapeutic agents are prescribed to children in continuing care at a rate between 5.5 and eight times higher than others.

    About 65 per cent of children in continuing care receive treatment for mental disorders, four times the general population.

    Victoria Times-Colonist

    © CanWest News Service 2006

    Tuesday, September 19, 2006


    Mother to view daughter's file
    Suicide controversy
    By Rebecca Walsh
    The Salt Lake Tribune


    The mother of a girl who killed herself in state custody will get to see case workers' report on the suicide.

    State Records Committee members Thursday reclassified the documents to allow Debra Langdon to read the internal Department of Human Services report. If unchallenged, the decision could open the reports to families of all children who die in foster care.

    "It's good for a start," said Wayne Searle, Langdon's attorney.

    Assistant Attorney General Debra Kurzban said she did not know if the state would appeal the committee's decision to district court.

    Langdon has been battling with the state since her daughter was handcuffed and led away from school more than two years ago. She has hired Searle and intends to sue, alleging state workers contributed to her daughter's death.

    "I want to change the system," she said. "I want the people who killed my daughter to be punished."

    Katherine Langdon was taken into state custody in March of 2004 when her mother appealed to the state for help with the girl. After months in detention for alleged drug use and three attempted suicides, the 16-year-old hanged herself in her foster home two years ago. Her mother argues state social workers and doctors did not take the earlier suicide attempts seriously enough and prescribed an anti-depressant drug that made the girl even more despondent.

    A year ago, Searle informed the state that he intended to file a wrongful death suit. In preparation, he and Langdon requested and received several documents from the state, including part of the Division of Child and Family Services' case file and copies of the girl's urine tests. But the state balked at providing a "Fatality Review Report."

    Human Services officials and state attorneys argue the reports are confidential under Utah's Government Records Access and Management Act, and Langdon does not have the legal right to get a copy.

    In a charged hearing Thursday, Searle compared the case to the nation's war against terror and initially accused Records Committee members of trying to cover up for DCFS. At one point, he threatened to bring in federal marshals to seize the records.

    "We have gotten very limited and redacted statements - all to support the family of the state," he said, implying the government is bent on protecting itself. "This death happened in 2004. It's 2006. They do not want to admit they have been negligent.

    "This mother has a right to know how her child was killed," he added.

    Langdon said the state kept her in the dark. "I never knew she was cutting herself. I never knew she was on Zoloft. I had no idea what she was going through," she said.

    State Archives Director Patricia Smith-Mansfield said she sympathized with Langdon, but tried to keep the hearing focused on the record in question.

    "I can feel a tremendous amount of despair," Smith-Mansfield said. "But the purpose of this committee is to decide the access to records."

    Kurzban urged committee members to keep the records - a "self-monitoring tool" for DHS - secret. She said Langdon could get much of the same information in the case file. Exposing the fatality reports would jeopardize internal department procedures and the anonymity of those involved in specific cases, she said.

    "In order for that process to be useful, all of those involved need to feel free to participate candidly," Kurzban said.

    Finally, Kurzban argued that Langdon and her daughter were not the subject of the fatality review; the Human Services department was. Therefore, Langdon had no right to the report under GRAMA.

    "The subject of the report is the system itself," Kurzban said. "It is not about any person. It is not about any family."
    Records Committee members were not convinced by that argument. "It is about a person," said Linda Thatcher. "I don't understand that."

    In the end, the committee reclassified the documents as "private" and ordered the report about Katherine Langdon's suicide released. Recommendations and an analysis of "systemic issues" at the end of the report will be blacked out.