The Good, The Bad and The Particularly Ugly. Days after scientist warned of Vioxx danger, FDA approved it for CHILDREN.

Motherjones Article on David Graham, FDA and Vioxx


"In exposing the deadly threat posed by Vioxx, FDA researcher David Graham was serving the public interest. His bosses had other interests in mind.

Michael Scherer
May 01 , 2005

DR. DAVID GRAHAM IS LOSING WEIGHT AGAIN. His wife noticed first, then his colleagues at the Food and Drug Administration. Graham is a skinny man, and when he drops weight, his cheekbones seem to sit higher on his face. His striped cotton shirts, the frumpy uniform of a government scientist, hang more loosely on his narrow frame. But he isn’t eating, and no wonder: Graham, the scientist who brought the Vioxx scandal to the nation’s attention, feels like a marked man.

“I’m no longer welcome,” he says, sitting in a Rockville, Maryland, coffee shop in early February. He has just left another frustrating day at work, where his boss warned him not to disclose new safety findings about a popular class of painkillers called Cox-2 inhibitors. In a few minutes, he is due at his son’s Boy Scout meeting, but all he can talk about now is the exhaustion of working in a drug-safety system in turmoil. “I’m hoping things will calm down, but I don’t think the FDA will let that happen,” he says. “How do you get off the merry-go-round?”

In August 2004, Graham told his supervisors that, in light of his research, high-dose prescriptions of the painkiller Vioxx, which appeared to triple heart attack rates, should be banned. They told him to be quiet. Their reasoning was circular: That’s not the FDA’s position; you work here; it can’t be yours. Dr. John Jenkins, the FDA director of new drugs, argued that because Graham’s findings didn’t replicate the drug’s warning label, Graham shouldn’t be raising the warning. Another supervisor, Anne Trontrell, called Graham’s position “particularly problematic since FDA funded this study.” Days after Graham’s pronouncement, the agency approved Vioxx for use in children.

But Graham was right. The following month, Merck pulled Vioxx from the market after its own research found that the drug, even when taken at low dosages, doubled the risk of heart attack. The announcement provided Graham no vindication. With a scandal on the horizon, the FDA brass now saw him as a danger. They couldn’t silence the message, so they tried to take out the messenger.

Dr. Steven K. Galson, the acting director of the drug-evaluation division at the FDA, told reporters that Graham’s work “constitutes junk science.” Then he sent an email to an editor at the prestigious British medical journal The Lancet, questioning the “integrity” of Graham’s data—a suspicion that proved baseless. The FDA’s acting commissioner, Dr. Lester Crawford, criticized Graham for evading the agency’s “long-established peer review and clearance process.” Another official made calls to at least one Senate staffer, disparaging Graham personally and professionally.

Eventually, he was heard. In November he went before the Senate Finance Committee hearing on Vioxx. Gaunt (he’d lost 12 pounds over three months) but very lucid, Graham took his place before a bank of cameras, wearing his only sport coat, a 20-year-old blue blazer with brass buttons. He explained his conclusion that patients taking high doses of Vioxx were suffering heart attacks. “The estimates range from 88,000 to 139,000 Americans,” he said. “Of these, 30 to 40 percent probably died. For the survivors, their lives were changed forever.” According to the top end of those projections, the toll Vioxx had already taken was comparable to the number of Americans killed in Vietnam. “The FDA, as currently configured,” Graham told the committee, “is incapable of protecting America against another Vioxx. We are virtually defenseless.”

But three months later, as Graham sips iced tea in a Rockville café, the FDA is again trying to suppress his research, this time on the effects of pain medications similar to Vioxx. “I think we’ve already articulated our preference,” his supervisor, Dr. Paul Seligman, wrote him in a terse email. The agency doesn’t want Graham presenting his latest research to scientists who will be meeting in a few days to discuss the drugs.

David Graham is headstrong, but not insubordinate. He cannot afford to lose his job. His family has just moved to a new house. His wife, Nancy, stopped working as a lawyer so she could homeschool their six children. Really, though, he has no more time to sit here worrying. The Boy Scouts are competing for their merit badges this evening. He finishes his iced tea.

“I’ve made a commitment,” he says, before walking out the door. “I’ll weigh myself this evening.”



WE LIVE IN THE pharmaceutical era of medicine, a time of tablet-sized miracles and blockbuster serums. More than 70 new drugs are approved every year, adding to the thousands for which American doctors already write some 3 billion annual prescriptions. The medications prolong countless lives and cause millions of harmful side effects. For most patients, the benefits far outweigh the dangers. An aging man will risk diarrhea to restore his virility. A cancer patient will lose her hair in the hope that chemotherapy will save her life. FDA safety officers like Graham spend their lives searching out the other type of pills, the unexpected killers that harm patients after the FDA has approved them.

Since 1988, Graham has called for the removal of 12 drugs from pharmacy shelves, leading to 10 recalls that have likely saved hundreds, if not thousands, of lives. Each recall is an embarrassment for Graham’s employer, the FDA’s Center for Drug Evaluation and Research, which approved the drugs in the first place. The trouble is that the roughly 2,300 staffers who support the approval process, and the 109, like Graham, who study the safety of drugs after their release, all fall under the same leadership, and that leadership is highly responsive to industry. In recent years, nearly half of the center’s $400 million budget has been paid for by drug companies. This arrangement stems from a 1992 agreement, made partly at the urging of AIDS activists, that the FDA would speed up approvals in exchange for “user fees” from industry. “The focus at FDA is efficacy,” says Dr. Curt Furberg, a scientist at Wake Forest University who advises the agency. “Safety is a stepchild.”

For the pharmaceutical companies the system works just fine. “The drug-approval process [in the United States] is second to none,” says Jeff Trewhitt, a spokesman for PHRMA, the drug industry’s trade group. “This is an exhaustive process.”

Companies eventually recall about 3 percent of their drugs for safety reasons. Behind many of these recalls are scientists like Graham, who often find themselves pitted against their own supervisors. “If you say something negative about a drug, they try to shut you up,” says Dr. Sidney Wolfe, an FDA watchdog for the group Public Citizen, which has been exposing dangerous drugs for three decades. “David is not the only one, by any means, who has raised issues that later proved to be correct.”

In 1998, for instance, an FDA drug reviewer named Dr. Robert Misbin wrote a paper showing that the diabetes drug Rezulin had caused liver failure in a patient during a controlled study. When his bosses tried to prevent him from publishing, Misbin saw firsthand how the system encouraged the sacrifice of public health to the interests of the industry. “One of my supervisors said something to me that I have never forgotten,” Misbin says, “that we have to maintain good relations with the drug companies because they are our customers.” Misbin eventually went public with his concerns, and the drug was pulled a year later. But he has paid for sticking to his principles. “I am no longer given any good projects,” he says.

Dr. Andrew Mosholder, another FDA reviewer, faced similar pressures last year when he completed a study showing that antidepressants increased suicidal behavior in children. Further studies proved that Mosholder’s science was spot on. But his bosses told him not to report the findings. When someone with access to the study passed his results to the press, the FDA launched an investigation into the leak. According to Tom Devine at the Government Accountability Project, who later became Graham’s lawyer, several scientists were interrogated and threatened with possible jail time.

Such intimidation has worked. In 2002, about one in five FDA scientists told federal investigators that they felt pressure to approve drugs despite reservations about safety and efficacy. Two-thirds said they lacked confidence that the agency adequately monitors drug safety after approval.



Michael Scherer is the Washington correspondent for Mother Jones. "

Children on Ritalin. What they have KNOWN for 35 years.

But they're still 'experimenting' with children by putting them on legal speed.

Ritalin is also becoming a huge problem as a desirable street drug and children buy and sell it at schools. And why wouldn't they - its a drug which is endorsed, promoted and distributed by those educated adults whom they are taught to respect:
Government officials, Psychiatrists, GPs, Industry 'Scientists', Social Workers, Teachers, School Nurses and others.


In Vancouver,Canada, the Police Chief stated:
(News Article)
"...that 80% of the crime in Vancouver would cease if Ritalin could be taken off the market. This situation is now well underway in Europe and the US as well..."


They have known since at least 1971 that Ritalin is NOT effective. That Ritalin is destructive, addictive and causes homicidality and suicidality. But the Legal Drug Pushers ignore it all in their pursuit for profits and, as always, its at the cost of lives.

LINK TO ARTICLE

"Learning Disabilities Online
Ritalin Effects

In a study entitled “Hyperactive Children as Teenagers: A Follow-up Study” (1971), eighty-three children were followed from two to five years after being diagnosed as hyperactive or as having attention deficit disorder. Ninety-two percent of the children were treated with Ritalin. Results were as follows:

60% of the children were still overactive and had poor schoolwork (the original reasons for being put on Ritalin), but in addition were now viewed as rebellious;

59% had had some contact with the police;
23% had been taken to the police station one or more times;
58% had failed one or more grades;
57% had reading difficulties;
44% had arithmetic difficulties;
78% found it hard to sit still and study;
59% were viewed as a discipline problem at school;
83% had trouble with frequent lying;
52% were destructive;
34% had threatened to kill their parents;
15% had talked of or attempted suicide.
Another research study, the Satterfield study (1987), states,

We found juvenile delinquency rates to be 20-25 times greater in our hyperactive drug-treated only group than in the normal control group. In the “Delinquency outcome for the drug-treated group,” the results were: of 61 boys, 46% were arrested for one or more felony offenses before age 18; 30% were arrested for two or more felony offenses; 25% were institutionalized.… Studies of the long-term effectiveness of drugs have been consistently discouraging.

There is also scant evidence of improved academic performance with stimulant treatment. According to Rooney, research has still not shown the use of medication to be significantly effective in the treatment of processing deficits or academic achievement. In The Learning Mystique, Gerald Coles confirms the findings of a 1978 review of both short- and long-term studies on the use of stimulants with children who were hyperactive and learning disabled. Of a total of seventeen studies included in this review, short- or long-term, whether they met basic scientific criteria or not, all the conclusions agreed: “stimulant drugs have little, if any, impact on…long-term academic improvement.” Their major effect seemed to be an “improvement in classroom manageability.”

In the Journal of Behavioral Optometry (1991), a study evaluated twenty-two previous studies/articles since 1976 concerning Ritalin use for hyperactive children. It states:

The fact that the above studies do not show the efficacy of Ritalin for helping hyperactive children should be apparent to the skeptic and make a skeptic out of the believer. But the argument should not stop at this point. The weak evidence for the value of Ritalin must now be viewed in the light of its reported side effects."

END OF ARTICLE

To see just a little of the evidence of the DEADLY results, see this blog's Links, Evidence section and download the "Homicides pdf" file. Ritalin has played a part in quite a number of school shootings in the US.

Its a permanent experiment on human beings.

The pharmaceutical industry and its host of benefitting 'stakeholders', psychiatrists, politicians, have no idea how any of the drugs actually work on any individual.
They DO know that the drugs are not "efficacious" as they pretend them to be.
And they DO know that the drugs kill.

Pharmaceutical LIES in Clinical Trial Results. SSRI 'Nausea' = Suicide

These are the lies on SSRI antidepressants. The lies that have caused uncountable numbers of suicides, homicides and disabilities as a result. Lies that Kill.
These are the drugs they already give to millions of adults, and millions of CHILDREN. The drugs they promote and the pharmapolitical financial interests behind Bush's New Freedom Commission and the proposal to screen EVERYONE in the USA for possible mental health problems. The drugs and the pharmapolitical financial interest behind the ever growing number of fictional mental "diseases" concocted by the American Psychiatric Association in order to boost prescribing and profit.


Extracts of correspondence from Professor David Healy to the UK drug regulatory body, the MHRA:

LINK TO SOCIAL AUDIT ARTICLE

"...Reports on these trials list patients who have committed suicide, and list those patients as being of a certain age and as having committed suicide at a certain point during the trial, when the patient in question has a very different age and the event in question happened at a completely different point during the trial...".

"...Miscoding of suicidal act as emotional lability..."

" ...Lilly have resorted to treatment non-response and a range of other headings to code what happened..." [re coding/mislabelling suicidal acts happening on clinical trials]

"...records on Prozac, Seroxat/Paxil and Lustral/Zoloft, you will find cases of homicidality coded as nausea for instance..."

"...Discontinuation of patients from studies for primary adverse effects such as nausea when in fact there has been a suicidal act;..."

"...But it is also worth adding specifically that this has been a feature of all trials of Zoloft/Lustral, Seroxat/Paxil and Prozac throughout, as far as I can make out... "

BBC transcript GUINEA PIG CHILDREN. AIDS drugs testing at NY Incarnation Childrens Center

BBC LINK TO TRANSCRIPT

"This World
Guinea Pig Kids
Tx Date: 30th November 2004

This script was made from audio tape – any inaccuracies are due to voices being unclear or inaudible

Dr David Rasnick
They were just experimenting, like you had a bunch of lab rats, an unending supply. You had subjects, you had drugs and you were just experimenting, throwing things around.

Boy
It’s just that I don’t like it when I see my best friends pass away, you know.

Vera Sherav
Would they have done those experiments to their own children? I doubt it.


Speaker
We have freedom in this country and that’s a wonderful thing isn’t it? When you can, we have freedom of religion and freedom of speech and that’s one of the cool things about being an American.

Amanda St John
Battery Park, in the heart of downtown New York. And a hymn to America in the last of the summer sunshine.

Amanda St John
New York is the richest city, in the richest country in the world.

Amanda St John
But just a few miles uptown live some of the poorest communities in America.

Amanda St John
In the Bronx three grandchildren try to bring their grandmother up to date with the latest fashions.

Amanda St John
But two people are missing from this picture. Veronica Momodu recently died of AIDS. It was left to her mother, Regina, to bring up three granddaughters and a grandson, Garfield, who’s HIV Positive.

Amanda St John
Veronica and Regina had wanted to have a say in the treatment Garfield received.

Amanda St John
But instead the New York authorities insisted Garfield stay on drugs and medicines, which even the other children could see were making him ill.


Nanju
When he was drinking the medicine sometimes at night, it was in the summer time too, and he would say, ‘mummy I’m cold, I’m cold’ or he would itch his body all over, non-stop.


Catherine
And every time he said he was cold, my aunt would tell my uncle to put the heat up, he put up the heat a lot of times, but he kept saying he was cold.

Interviewer
Is this why your family decided to stop the medicine?

Nanju
Yeah, my aunt stopped it because he wasn’t feeling comfortable.

Catherine
And he started to get well, but when she went for a check up, they gave him the medicine again without her knowing it.

Interviewer
And did he get sick again?

Catherine and Nanju
Yeah.

Regina Mousa
Grandmother
I don’t know what type of medicine they were giving.

Regina Mousa
The boy was allergic to sulphur and they give it to him and he’s scratching all over his body and he lost his appetite, he don’t eat and he was getting skinny and skinnier.

Amanda St John
Convinced that the medicines were making things worse, not better, they turned to their hospital doctor for advice. He made an unexpected offer.

Regina Mousa
My daughter told me, she said when she went to see the doctorand that time it was the child’s appointment the man said he would be giving her twenty-five dollars a month if they can put the child on experimental basis. She said ‘I will think about it’and she said ‘No’. Then the doctor said ‘You will regret it’.

Aston
Reconstruction

Amanda St John
Regina’s daughter took Garfield off all medication. Almost immediately his health improved. Then there was a knock on the door.

Regina Mousa
They came to take the child and they came with police.I think it was three or four policemen.

Amanda St John
In New York, you don’t need a court order to take a child from its parents. The Administration for Children’s Services, or ACS, has exceptionally strong legal powers to decide what’s best for the city’s kids.

Aston
David Lansner
Family Lawyer
They’re essentially out of control; I’ve had many ACS case workers tell me; ‘we’re ACS, we can do whatever we want’. And they usually get away with it.


Amanda St John
Garfield simply disappeared into the system; one of twenty-three thousand children placed either with foster parents or in children’s homes.

Amanda St John
This Catholic-run home, the Incarnation Children’s Centre in Harlem, is where many HIV children end up if their parents or guardians refuse to medicate them.

Amanda St John
For years it was the centre of highly controversial and secretive drug trials on orphans and foster children as young as three months old.

Aston
Jacklyn Hoerger
Paediatric Nurse
At the time it did not occur to me that anything was wrong because we were told by the doctors that these were all steps that were going to happen, to be expected because they were all HIV-positive.

Amanda St John
Jacklyn Hoerger is a paediatric nurse who worked at Incarnation for five years.

Jacklyn Hoerger
If they were vomiting, if they lost their ability to walk, if they were having diarrhoea, if they were dying; that all of this was because of their HIV infection and to be expected and that we were doing the best we could to save them from that.

Amanda St John
Jacklyn was completely unaware that she was party to experiments on children.

Jacklyn Hoerger
It didn’t come as my first thought at all to question the medication and since I had worked with paediatric AIDS for many years and had given the medication, I just faithfully gave it as I was told by the doctors.

Amanda St John
We found documentation listing some of the experiments carried out on HIV children at the home.

Amanda St John
One was for treating herpes; another involved giving children double doses of the measles vaccine.

Amanda St John
And yet others involved whole cocktails of drugs with side-effects admitted by the manufacturers including: severe stomach pain, muscle wastage, organ failure and many more.

Aston
Dr David Rasnick
University of Berkeley
Side-effect is a euphemism for, for undesired direct effects. The effects of the anti-HIV drugs are quite serious, in fact, in fact if you look at the insert that comes with these drugs you’ll see virtually all of them will have a black box warning label which is the highest, most severe warning that these drugs can have and still be prescribable to human beings before they’re taken off the market. They’re lethal.

Amanda St John
Three thousand miles west of Manhattan, Dr David Rasnick is internationally renowned for his work on numerous diseases, including cancer.

Dr David Rasnick
I’ll scroll that up a little so you can see the years and everything. And it’s Aids cases, deaths and…

Amanda St John
He’s studied the effects of HIV drugs on patients, particularly children.

Dr David Rasnick
The young are not completely developed yet; the immune system isn’t completely mature until a person’s in their teens, typically.

Amanda St John
We asked for his opinion on some of the Incarnation trials.

Dr David Rasnick
We’re talking about serious, serious side-effects.
Didanosine, all by itself is, is a very dangerous drug. Zidovudine is our famous AZT, which has never been shown to be life saving, it also causes severe anaemia. Nevirapine is the drug that also causes that Stephen Johnson Syndrome, the flaking of the skin and it’s very, very dangerous and debilitating, it’s horrible and painful and also lethal.


Dr David Rasnick
These children are going to be miserable; they’re absolutely going to be miserable. They’re going to resist taking them after a while, they’re going to probably take them when people give it to them, they’re going to suffer so much AZT by itself that they’re going to have cramps, they‘re going to have diarrhoea, they’re not going to want to eat, they’re joints are going to swell up, they’re going to roll around on the ground, you can’t touch them and I understand that the Incarnation Centre, they sent them to the hospitals, these children and they cut a hole in their belly and put a feeding tube in their belly and administer the drugs to the children who don’t take these drugs.

Boy
My friend, Jolice, she never, never ever liked to take her medicine. So they used to hold her down and force it down her throat. I tell her…


Amanda St John
This boy spent most of his life at Incarnation. Aged fifteen, after years on drug tests, he has the physique of a ten year-old.

Amanda St John
He didn’t want to show his face. But he did want to tell the story of what happened to him in the home.

Boy
I did not want to take the medications and I did not want to, you know, do all that stuff.

Interviewer
But they insisted?

Boy
Yeah, if you want to get out of there you have to do what they say or else you’re not going anywhere.

Amanda St John
His medical records, which we’ve obtained, prove that he was enrolled in drug trials while living at Incarnation.

Amanda St John
If a child refused to take the medicine, a peg-tube was inserted directly into the stomach; something he warned his friends about.

Boy
And I used to tell her every single day, ‘please take your medicine; you don’t want a tube in your stomach’. But she didn’t listen to me. That’s what she got. And my friend Daniel, he didn’t like to take his medicine either and he got a tube in his stomach.

Amanda St John
Under Federal rules consent for children to take part in drug trials has to be given by their parent or guardian. But the kids at Incarnation have no independent voice. The body that is their legal guardian, the ACS, is the same body that makes the children available for trials.

Aston
Vera Sherav
Alliance for Human
Research Protection
You would not expect too many parents to volunteer their loved children for such experiments. This means that if the researchers want to do the experiment on children, they are going to look for vulnerable children whom they can get. And when you have a city government agency accommodating them; that is the biggest betrayal of those children. They don’t have anyone but the city agency that is their guardian on paper but not in human ways.

Amanda St John
For over ten years, Vera Sherav has battled almost single-handedly with the New York authorities to come clean over the use of children in drug trials.

Vera Sherav
They tested these very highly experimental drugs,
Phase One and Phase Two, why didn’t they provide the children with the current best treatment; that’s the question that we have. Why did they expose them to risk and pain when they were helpless? Would they have done those experiments to their own children? I doubt it.

Amanda St John
When we spoke to the ACS early in our investigation, they told us that no child was
selected for trials without a long process of decision-making.

Vera Sherav
I would absolutely reject the idea that they go through a process. Yes, they go through a process, but it is in, in, on paper only. For example, the city department created a panel, an ethics committee that approved the experiments that were conducted at Incarnation House. There’s only one little pesky detail; the panellists all come from hospitals that conduct the trials, so they all are stakeholders in saying that it was perfectly all right.

Amanda St John
Most of the children in the trials are from New York’s poorest districts. Many were born to drug addicted mothers. Over ninety-eight percent of children in foster care in the City are black or Latino.

Amanda St John
It’s a very different story if you’re white, middle class and live outside New York City.

Amanda St John
Christine Majiore has been HIV positive for fourteen years and as an adult chose to decline all drugs offered; she’s never been sick.

Amanda St John
She lives in Los Angeles and when her children were born, she refused even to have them tested as she’d no intention of putting them on medication.

Aston
Christine Majiore
Mother
The drugs are very powerful, they’re known to be toxic, they can cause everything from liver failure to sudden death, heart attacks, strokes, paralysis, diabetes, pancreatitis. They’re, they’re devastating and the only reason to take them is the belief that one will die without them. That is something I don’t believe.

Amanda St John
Christine may not believe, but the authorities do. She received a phone call from the Los Angeles Welfare Services threatening to take her children away.

Christine Majiore
It was the most horrible event of my life, to think that someone who didn’t know me, who had no idea of how much I love my children, how I labour over every decision from what they eat to where they got to school and I work so hard to provide them with the best care so they grow into loving, healthy, responsible individuals, that with one phone call they could actually put me at risk of losing my family.

Christine Majiore
I would like to order a salad… The difference for Christine was that she could afford lawyers and that the authorities in LA were prepared to listen to what they had to say.

Interviewer
How did you fight it?

Christine Majiore
Attorneys and excellent medical records. My children see two separate private practice paediatricians, they always have. We take them even though they’ve never been ill. My children are so gloriously healthy they’ve never had any of the typical childhood problems from ear infections to respiratory infections, nothing. And so we have excellent medical records and I work with a big team of lawyers and I just prepare myself.

Amanda St John
Christine fought and won. You can do that in Los Angeles.

Amanda St John
But in New York City, where the ACS was given special powers by former Mayor Rudi Giuliani, even professionals realise they are fighting a losing battle.

Amanda St John
Jacklyn Hoerger, the nurse who had once administered the drugs to children at Incarnation, was about to discover just how difficult it really was. She’d decided to add to her existing family by adopting two young girls she’d grown to love at the home.

Jacklyn Hoerger
They were half-sisters and the younger of the two was pretty much immobile; didn’t know how to walk, didn’t know how to play, didn’t speak much, didn’t know how to show her emotions or feeling whatsoever. And her sister was the opposite; she was hyperactive, couldn’t sit for a minute, couldn’t be still for a minute and wouldn’t eat and the younger of the two overate. So it was a complete mess.

Jacklyn Hoerger
I gave them all that I could, on every level. I gave them the good quality food, the rest, the best private schooling they could get, occupational therapy, physical therapy, speech therapy, tutoring. The best psychologists I could find on all levels and I just didn’t seem to be making any headway. And the only thing that was left was the medication that I had been giving them.

Amanda St John
Jacklyn decided to take the children off the drug regime which Incarnation had insisted upon. The results were almost instantaneous. The older girl began eating properly for the first time.

Jacklyn Hoerger
She would ask for seconds and thirds and it started showing on her body. When we swam at a swim club that we go to she had a swimsuit on about a month or two after I took her off the medication, I just looked at her with those loving mother eyes, just seeing a daughter look beautiful, rounded out, muscular, strong and healthy. It was a wonderful sight.

Jacklyn Hoerger
The younger daughter, I would say, the main change after I took her off the medication, it felt that her nerves became more and more healthy and I taught her how to walk, run, jump on the trampoline, play, ride the bicycle, swim and it was a joy to watch her.

Aston
Dirk Hoerger
I remember the first Christmas when they all got new hats and they sat in the corner all three of them together next to the Christmas Tree in their new hats surrounded with their presents and Ilene had this little shy smile, Olivia beaming from ear to ear and Leah sitting over them.

Daughter
And on Christmas morning, I woke and there was the faintest red on the horizon and so I turned on the light and we all got up and we opened our presents, you know, our stockings, and we started yelling out the window; ‘thank you Santa Claus’. And then Mommy came stomping, stomping down the stairs; ‘how dare you guys, it’s only one o’clock in the morning’.

Amanda St John
Not long after those Christmas celebrations, there was a visit; from the ACS.

Jacklyn Hoerger
It was a Saturday morning and they had come a few times unannounced so when I saw them at the door, I invited them in and they said this is not a happy visit and at that point they told me that they were taking the children away. I was in shock; I couldn’t believe it and we were, it was a home day and they were in their pyjamas and…

Amanda St John
The social worker involved in the case was Demetrius Travis. He was on holiday when a temporary case worker arrived at their door with the ACS.

Aston
Demetrius Travis
Social Worker
The family did not agree with the drugs that were being given to these children who had HIV and as a result of the parents not agreeing with the, the medicinal, I guess, regimen that was being administered to the children when it was learned that that regimen was not being followed the children were taken back into foster care.

Interviewer
Did that decision upset you?

Demetrius Travis
It bothered me yeah, because I can remember how well off these children seemed to be and, and that just wasn’t, that wasn’t just my opinion that was the opinion of this mental health professional who had dealt with these children over a period of, I would say, a year and a half, two years.

Amanda St John
As a result, Jacklyn was taken to court and convicted of child abuse.

Interviewer
Where are they now?

Jacklyn Hoerger
I don’t know. I’m not allowed to know.

Amanda St John
Jacklyn’s greatest fear is they’ve been returned to Incarnation Children’s Centre or a similar home in New York where they might be subjected to experimentation.

Aston
Bill Perkins
New York City Council
Well it is shocking that in New York City, experimental drug treatments are being used on children who are in foster care.

Amanda St John
Even senior politicians in the city have found it impossible to get information about the trials. Bill Perkins is Deputy Majority Leader on New York City Council.

Bill Perkins
We do know that several have passed away during the course of these experiments and we know that there are still some involved and there’s been somewhat of a secrecy about the whole matter, I must say. It has not been easy to get through the bureaucracy as to exactly what this is all about.

Amanda St John
In a mass grave owned by the Roman Catholic
Church close to Manhattan, over a thousand children’s bodies, including some who were enrolled in the trials, lie beneath a tarpaulin. Officially their deaths are recorded only as resulting from ‘natural causes’.

Amanda St John
For months, we tried to get answers from those behind the trials.

Amanda St John
From Columbia Presbyterian Hospital, where many of the tests were devised.

Amanda St John
From Incarnation Children’s Centre. From the Catholic Church.

Amanda St John
And from the ACS; the authority ultimately responsible. None would comment.

Amanda St John
The drug companies which have supported trials at Incarnation include some of the world’s largest..

Amanda St John
Among them Britain’s own Glaxo Smith Kline.

Amanda St John
They also refused to be interviewed for this programme saying only that all trials have stringent standards and are in compliance with local laws and regulations.

Amanda St John
In Washington, officials at the National Institutes for Health insist that any participation of children in drug trials should be voluntary in every sense.

Aston
Lauren Wood
National Institutes of Health
We let parents know that participation is always voluntary; that they can stop participating in a trial at any time. Many parents need to have that reinforced, that participation is voluntary. We also get the assent of the child, when it’s appropriate.

Amanda St John
But what if that child is in the care of New York City authorities which have volunteered it for the trials in the first place?

Aston
David Lansner
Family Lawyer
New York Law hasn’t made clear where the boundaries are between the parent’s right to provide and control the treatment for the child and the ACS’s right. And as a result, the parent loses out and the child loses out because ACS simply says; ‘we’re going to make all the decisions’.

Amanda St John
In two thousand and two, the trials at Incarnation were suddenly halted. Attempts to uncover why exactly meet either with silence…..

Amanda St John
…or a call to the NYPD to have us removed.

Amanda St John
During the making of this programme the Food and Drugs Administration announced an investigation into the trials, which we have discovered are continuing at at least six other locations in New York City.

Amanda St John
Meanwhile, Regina Mousa from the Bronx is now in contact with her grandson, Garfield.

Amanda St John
She’s won a court order granting her visitation rights.

Amanda St John
This is her grandson’s new foster home in the Bronx.

Amanda St John
The boy was hungry and Regina had brought food. Although the house was in poor condition, it was better than his previous one where the foster mother had allegedly beaten him.

Amanda St John
Garfield’s new foster mother receives six thousand dollars every month for him and three others.

Amanda St John
What makes her a better guardian in the eyes of the authorities is that she gives the medicine demanded by the ACS and Regina refuses.

Regina Mousa
I want to get him back. I want to get him back. Because I don’t want my child to remain in experimental basis. Not my own grandson. Because we love him.

Amanda St John
Jacklyn Hoerger has had no news of the two little girls she was adopting since that day when the ACS arrived on her doorstep.

Jacklyn Hoerger
We weren’t given any rights whatsoever. I even wrote a letter to the social worker appealing to her humanity, to just let us know something. But I don’t know anything.

Interviewer
Did you ever say to the nurses or the doctors that you felt the medicine was wrong?

Carlos
I try; I just try to be me. I don’t bother anybody. People do things for, like I said, a reason; good or bad, we have to forgive them for what they do.

bbc.co.uk/thisworld

Dr Yolande Lucire SSRI SUICIDE STATISTICS

Some very interesting observations and articles regarding SSRIs on Dr Lucire's site which is here:
Dr Lucire's home page

And this her article titled:

Do SSRIs Cause Suicide
(converted from a PowerPoint presentation)

"Antidepressants form two major groupings: New SSRIs and older TCAs, which I’ll call TricyclicsSSRIs act on Serotonin and have profound effects. They are capable of changing people profoundly and not always for the best. Contrary to popular opinion, there is no scientific evidence that serotonin is abnormal in depression.Having more of it floating around makes for a lot of change.

SSRIs (the Accused) TCAs (the Comparator) Prozac Tryptanol Zoloft Tofranil Aropax Prothiaden Efexor SinequanCipramilLexaproLuvox


Caution:Do not stop taking an antidepressant without medical supervision.Complications occur on starting, stopping and with irregular dosing. Withdrawal can start up to four weeks after stopping the drug and can go on for three months Complications include agitation, mania, psychosis and self harm and suicide and violence and homicide.


The possibility that a drug was causing the effects it was supposed to cure was unthinkable, especially by clinicians.But it is accepted: SSRI-induced akathisia is in the latest Diagnostic and Statistical Manual, the ever expanding list of mental disorders. DSM

How common is it?A 2001: Yale: 8% of patients admitted ‘may suffer’ from SSRI-induced mania or psychosis.Higher levels of prescribing in OZ and including agitation, suicidal thoughts and attempts, its more like 20%.

I will give you Daubert competent science. Science that has passes 6 Daubert Hearings.Scientific (as opposed to opinion) evidence is the only kind of expert evidence admissible in American and Australian courts Scientific evidence that SSRIs cause: Suicidal thinking Suicidal acts Completed suicide.

The 1993 US Supreme Court Decision in Daubert v. Merrell Dow Pharmaceuticals altered the criteria by which scientific testimony is admitted as evidence in court. The unanimous ruling states that the criterion of the scientific status of a theory is that it can be tested, refuted and falsified.Scientific method is based on generating a null hypothesis, a conjecture that something does not exist, and testing it to see if it you can prove the contrary.The unicorn does not exist. The prisoner is not guilty. These are respectively good science and good law Disproving the negative differentiates science from other forms of inquiry William Daubert, et ux., etc., et al., Petitioners v. Merrell Dow Pharmaceuticals, Inc.Supreme Court of the USA, June 28, 1993.

We need to watch two numbers RELATIVE RISK RR SUICIDE RATE /100,000

A Relative Risk, RR, is how many more times SUICIDE and its precursors THINKING OF SUICIDE AND SUICIDAL ATTEMPTS occur in SSRI-TREATED PATIENTS over and above those treated with a Tricyclicor not treated at all.

If a medicine saves some depressed patients from committing suicide, the RR between that medicine and no treatment should be less than 1.Tricyclics generally had an RR of 0.5 against no treatment, in "hospital" depressions, in which suicides were a known risk. Tricyclics halved the number of suicides in a seriously depressed population.

Tricyclics were known to cause suicide by energising the depressed, but RR was still favourable.If the relative risk equals 1.0, the risk in treated individuals is the same as the risk in untreated ones. If the relative risk is more than 1.0, the risk in treated is greater than in untreated.As we are trying to prevent suicide, an RR of 1 would be ominous.

Eli Lilly (Prozac) Pfizer (Zoloft) and GSK (Aropax) proposed in 1999, the cut off point of SIGNIFICANCE, Relative Risk, RR, be 2.0. Ridiculously HIGH by any standard. Corporate chutzpah.

Exposure to asbestos is deemed contributory to cancer if the RR is only 1.2 which is 20% higher. Asbestos was never expected to PREVENT cancer. AN RR OF 2 IS FIVE TIMES THAT.

The evidence for suicide induction can be found in many areas of research1. CLINICAL PSYCHIATRY Observations and mechanisms Challenge-Dechallenge-Rechallenge experiments Studies of NEW suicidal ideation, (Fava)2. SUICIDE EPIDEMIOLOGY SUICIDES BY PRESCRIBED DRUG JICK, UK DSRU DONOVAN POPULATION STUDIES , PRIMARY CARE HEALY AND BOARDMAN3. HEALTHY VOLUNTEER STUDIES 4. RANDOM CONTROL TRIALS (RCTs) The evidence from all these sources is overwhelmingly supports a relative risk of suicide by SSRI users of greater than 2, and sometimes as high as 8 or 10.

CLINICAL PSYCHIATRY 1990 American Journal of Psychiatry. 147(2):207-10, 1990 Feb.Abstract Teicher Glod and Cole. Six developed intense, violent suicidal preoccupation after 2-7 weeks of Prozac which persisted 3 days to 3 months after Prozac was stopped. None had ever experienced a similar state .Drug companies called this ‘anecdotal’ and said "It’s the disease not the drug, doctor" Now scores of such reports, patients treated for anxiety, eating disorders,OCD and menstrual problems and children

CLINICAL PSYCHIATRYTeicher and Cole (1993) delineate 9 "clinical mechanisms" by which SSRIs can induce or exacerbate suicidal tendencies by: (1) energizing depressed patients, (2) paradoxically worsening their depression , (3) inducing akathisia, (4) inducing panic attacks, (5) switching patients to mania or hypomania, (6) causing insomnia or interfering with sleep architecture (esp. with REM sleep), (7) inducing an organic obsessional state, (8) promoting personality disorder with borderline traits, (9) producing EEG or other neurological disturbances.

Those at risk of suicide are agitated,in turmoil, nervous, sleepless, pacing, energized, almost manic, and they reject their obsessive suicidal thoughts as ‘strange’, ‘weird,’‘not me’.This can go on for weeks or can turn into suicide unpredictably in a matter of minutes.Teicher and Cole, 1993 Healy, Langmaak, and Savage, 1999;’

The traditional suicidogenic triumvirate of psychotropic drug reactions are 1) akathisia, (2) emotional blunting, also called psychic numbing "I cannot feel anything, do not care" and/or (3) psychotic decompensation Akathisia is turmoil, feeling numb as if nothing matters, and feeling one is going mad. It can happen over weeks or days, or very very quickly, in a matter of minutes. Teicher and Cole, 1993 Healy, Langmaak, and Savage, 1999;

CLINICAL PSYCHIATRY1991: Suicidal thinking (out of the blue)Fava and Rosenbaum found suicidal thinking developed in patients who had never been suicidal before, more on Prozac than on other drugs. Prozac v TCAs = RR = 2.7Scores of reportsFava, M. & Rosenbaum, J. 1991. Suicide and 3 fluoxetine. Journal of Clinical Psychiatry, 52-5.

CLINICAL PSYCHIATRYSUICIDAL ACTS 2 of 26 depressed patients overdosed in the first 2 weeks when Prozac was increased quickly. 7.6% is an extremely high rate. M. Muijen, et al., A Comparative Clinical Trial of Fluoxetine, Mianserin, and Placebo in Depressed Outpatients, Acta Psychiatrica Scandinavica, Vol. 78 (1988), pgs. 384-390).

CLINICAL PSYCHIATRYChallenge-Dechallenge-Rechallenge CDRThere are many Challenge-Dechallenge-Rechallenge studies. Suicidality starts on drug, clears up when it is stoppedand Reappears on re-exposure, even to another SSRI.

SUICIDE EPIDEMIOLOGY: JICK Against concerns that Britain’s most popular TCA antidepressant, Prothiaden, dangerously toxic in overdose and being labeled as a ‘dirty drug by SSRI mfrs.Jick examined 172,598 persons and 1.2 million scripts for 10 antidepressants, old and new, general practice patients 143 had committed suicide.Jick S, Dean AD, Jick H (1995). Antidepressants and suicide. British Medical Journal 310: 215-218

SUICIDE EPIDEMIOLOGY : JICK Prothiaden turned out to be the safest as only 14% of suicides involved antidepressant overdose. RR of SUICIDE Prozac v all TCAs RR = 6.6 Prozac v Tofranil RR = 1.9 Prozac v Amitriptyline RR = 4.0 Prozac v Prothiaden RR = 2.1 Prozac v Lofepramine RR = 4.04 SSRI overdoses are not fatal. SSRI suicides tend to be violent: hanging, drowning, shooting, jumping, stabbing or cutting, dying on a railway, burning, electrocution, or deliberate road accidents.


SUICIDE EPIDEMIOLOGY: JICK Jick was embarrassed and suggested that ‘selected’ patients may have been given Prozac, which had a high suicide rate attached.

SUICIDE EPIDEMIOLOGY : DRUG SAFETY RESEARCH UNIT UK (50,000 pop.)The DSRU follows up drugs in the community it looked at completed suicides and what medicines they had been prescribed.Suicide rate on SSRIs = 219/100,000.Prozac 244/100,000 Aropax [PAXIL/SEROXAT] 269/100,000 Luvox [FAVERIN] 183/100,000


Boardman and Healy investigated 475,000 over 5 years counting all the mood disorders in all the private practices and suicide rates for these disorders


SUICIDE EPIDEMIOLOGY: Boardman & Healy PRIMARY CARE SUICIDE RATES All mental disorders < 27-67/100,000. Fits in with other primary care mood disorders suicide statistics Holland 30/100,000 Sweden 0/100,000Antedating SSRIs Simon, von Korff 30/100,000 Highest UK rate 68/100,000Boardman AP, Healy D. Madeley suicide risk in primary care primary affective disorders. European Psychiatry. 2001; 16: 400-405.

SUICIDE EPIDEMIOLOGY: DONOVAN again sought to establish the safety of SSRIs against TCAs which were toxic in overdose. Examined 222 COMPLETED SUICIDES, and the medicines they had been taking, and found SSRIs v TCA RR= 2 Donovan S, Kelleher MJ, Lambourn J, Foster R. The occurrence of suicide following the prescription of antidepressant drugs. Arch Suic Res. 1999; 5: 181-192.

SUICIDAL ACTS: DONOVAN At the same time, DONOVAN looked at 2776 acts of DELIBERATE SELF HARM in 1954 persons presenting to emergency and what they were taking Aropax v Tryptanol (TCA) RR = 4.0 Prozac v Tryptanol (TCA) RR = 6.6 Zoloft v Tryptanol (TCA) RR = 4.9 Aropax v Tofranil (TCA) RR = 1.9 All SSRI v Tofranil (TCA) RR = 5.5 Donovan S, Clayton A, Beeharry M, Jones S, Kirk C, Waters K, Gardner D, Faulding J, Madely R. Deliberate self-harm and antidepressant drugs. Investigation of a possible link. Brit J Psychiatry. 2000; 177: 551-556

HEALTHY VOLUNTEERS Healy: 2 of 20 healthy volunteers suicidal on Zoloft.

2 healthy volunteers have suicided: 19 year old Traci Johnston, a healthy volunteer, suicided February 7th 2004 in a trial of Eli Lilly's new Serotonin drug - duloxetine [CYMBALTA/YENTREVE], for incontinence aborting the trial Reported in Sydney Morning Herald Lilly had been doing clinical trials in Australia

Result:You cannot set up a trial to see how many people kill themselves as a consequence of the drug you are testing It would be impossible to get insuranceor ethics approval. Or informed consent? Have to make do with information we have.Emergence of antidepressant suicidality, published in 2000 in Primary Care Psychiatry (Vol. 6, No. 1).

RANDOM CONTROLLED TRIALS (RCTs)SUICIDES AND SUICIDAL ACTS2003, Khan et al. looked atBLIND CLINICAL TRIALS from 1986-90 Presented to the US Federal Drug Administration, to get SSRIs licensed. FOR9 Serotonin ANTIDEPRESSANTS against comparators and placebos.

Kahn found NO DIFFERENCE in suicides and suicidal acts between those on SSRIs or on COMPARATOR DRUGS or PLACEBOS48,277 depressed patients participated in the trials,and 77 committed suicide. That’s a lot. Am J Psychiatry. 2003 Apr;160(4):790-2.

RANDOM CONTROLLED TRIALS SSRIs had failed to demonstrate usefulness in hospital depressions. (We still give as much ECT as we ever did) so ‘hospital patients’ carrying suicide risk were not recruited into these trials.SSRIs were aimed at general practice. ‘Samples of convenience’ patients under stress, with minor disorders, The Valium using population of the 1970sWith suicidal patients filtered out.

In September of 2003, Healy and Whittaker re-evaluated the same, original FDA studies. They published a watershed paper in September 2003. Antidepressants and suicide:risk–benefit conundrums David Healy, MD; Chris Whitaker, MScHealy — Department of Psychological Medicine, University of Wales College of Medicine, Hergest Unit; Whitaker — Department of Informatics, University of Wales Bangor, Bangor, United Kingdom. J Psychiatry Neurosci 2003;28(5):331-7

Whereas Kahn had coded as ‘placebo suicides’ those within 2 weeks of stopping an SSRI Healy and Whittaker recognised these 5 SUICIDES and MANY SUICIDAL ACTS AS ‘SSRI WITHDRAWAL SUICIDES’.

Khan had counted suicides per number of patient years exposed to the drug, PEYs .Healy counted suicides per number of patients treated

Healy argued that the risks of SSRIs resembled the risks of space travel which, mile for mile, was the safest form of transport available. But going up and coming down are the danger periods for both.


But landing and re-entry occurs each time a dose is forgotten, not absorbed, taken with alcohol or if a co-prescribed medicine is added or removed.




Summary: Incidence of Suicides and Suicide Attempts (combined) in Antidepressant Trials From FDA Medical Reviews

FDA TRIALS SUMMARY 26,000 subjects SUICIDE RATES ALL DRUGS SUICIDE = 232/100,000SSRI SUICIDE = 186/100,000 PLACEBO SUICIDE = 64/100,000RELATIVE RISK FDA TRIALSSUICIDE ON SSRI RR = 2.4 (CI 0.6-10.2)SUICIDAL ACT ON SSRIS RR = 2.2 (CI 1.4-3.5)S/ ACTS ON NEW ANTIDEPRESSANTS RR = 4.3 (CI 1.1-17.8)

SUICIDE RATESDRUG SAFETY RESEARCH UNIT SSRI SUICIDE = 212/100,000JICK PROZAC in first 30 days of treatment 274/100,000 PEYsPROZAC 93/100,000

SUICIDE EPIDEMIOLOGY: Boardman & Healy and many othersAntedating SSRIsPRIMARY CARE SUICIDE RATES < 27-68/100,000 MAXIMUM ANY POPULATION STUDY 68/100,000Boardman AP, Healy D. Madeley suicide risk in primary care primary affective disorders. European Psychiatry. 2001; 16: 400-405.

Healy and Whittaker’s conclusion was modest: It is no longer possible to support the null hypothesis that SSRIs do not cause suicide The null hypothesis has been falsified.

Any way you look at available information, clinical settings,emergency rooms, morgues, clinical trials,SSRIs as a general cause of suicide would pass the scientific standard of proof.The BMJ issued warnings on February 5 2004.FDA on March 23Most manufacturers put on Websites on May 3, 2004. Only in USA.


WARNING MAY 3 2004… patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

WARNING MAY 3 2004 Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and non-psychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers

Unlike smallpox, depression has not been disappeared since a cure became availablePotentially fatal complications of any treatment might be acceptable if the treated population were small, dangerously ill, at high riskthe availability of a remedy has increased the diagnosis of depression a thousandfold.and lethal side effects have increased by the same multiplier.

The drug manufacturers promote the medicalization of stresssubsidize psychiatrists, journals, conferences. Encourage moral entrepreneurs of health whotalk about cases undiagnosed, and so untreatedJohn Merson calls this phenomenon ‘epistemic capture’: the control of knowledge by vested interests.

200/100,000 represents 1 death in 500 people treated with SSRIs in primary care.68/100,000 v 200/100,000A least 100 suicides per 100,000 over treatment with other drugs or non treatment.By 2003, over 28 million people had started Prozac since its launch in 1988.

6,664,960 prescriptions for SSRI written 2003 by Australian doctors.Twelve times the annual number studied by Donovan40% of first prescriptions remain unfinished, because of side effects. PBS spends $160 million a year on SSRIs.Cui Bono?

I in 500 too rare for clinicians to see.They need advice from suicide epidemiologists and statisticians.Opinion evidence is not admissible. ‘We are not convinced’ and ad hominem arguments do not get admitted as evidence. 1 in 500 is well above Rogers and Whittaker’s, 1 in 14,000 and demands a duty to warn of a catastrophic side effect.

Someone has that duty.Who will tell the prescribing doctor? The manufacturers have not done so in Austrlalia. The Therapeutic Goods Administration has not issued warnings. The Federal Drug Administration in USA argues that its role is licensing drugs, not protecting the public.Psychiatrists, all clinicians, are ‘not convinced’.

Some more alarming informataion has emerged from David Healy's re evaluation of the clinical trials of antipsychotic drugs presented to the FDA.It concerns commonly prescribed antipsychotic drugsThe regulator, the FDA, just did not notice in the late 1980s that one in 208 or 12 in 2,500 clinical trial subjects committed suicide while Zyprexa was being trialled and only one on placebo and one on a comparator, most likely haloperidol did that.


The subject numbers are so small that relative risk cannot be calculated, but Zyprexa (Olanzepine) trials had the highest rate of suicide in clinical trial history. Suicidal Acts have not been reportedRisperdal was not far behind Zyprexa. The mechanism is thought to be similar,through causing akathisia and doing these drugs synergistically with SSRIs. Doctors have not been warned.

All Truth passes through Three Stages: First, it is Ridiculed... Second, it is Violently Opposed... Third, it is Accepted as being Self-Evident.Arthur Schopenhauer (1778-1860 )

In Friedson’s account, moral entrepreneurs in medicine are commonly part-time practitioners who crusade in health matters. The thrust of their activity is towards political power as they seek to implement measures designed to improve what they see as public health. They give press interviews and try to give testimony in court.

They are often responsible for legislation. They want to place jurisdiction for their concerns in the hands of health professionals rather than leave them with society. Freidson identified lay interest groups, sometimes led by, and always including, prominent physicians, whom he described as ‘the most flamboyant moral entrepreneurs of health, untrammelled by professional dignity, crusading against the menace of a specially chosen disease, impairment or disease-producing agent’

Such moral entrepreneurs, essential players in any moral panic, are ubiquitous. Professional entrepreneurs are creating panics about the consequences of child sexual abuse, others about failing to have professionals attend immediately on persons involved in traumatic events and about depression which had become the greatest scourge of modern society.

They advert to cases of undiagnosed and untreated post-traumatic stress disorder and depression, which medication would surely cure. They attribute to these evils a status of being important causes of personal failure and society’s epidemic ills.

Physician moral entrepreneurs are likely to see the environment as more dangerous to health than does the layman, and to emphasise the seriousness of the health problem preoccupying them by estimating the cases probably undiagnosed and therefore untreated.

They are disposed to see mental illness where the layman sees nervousness, to see illness where the layman sees variations within the broad range of normality, to see a serious problem where the layman sees only a minor one. They are biased towards the creation of sick roles and press their licence as physicians to manage the newly defined sick within their relevant speciality frameworks.

In brief, the medical profession is more prone to see illness and the need for treatment than it is to see health and normality. This selective perception is both self-confirming and self-sustaining."

END OF ARTICLE

Aropax is known in the UK as Seroxat and in the US and Canada as Paxil so I've inserted [PAXIL/SEROXAT] where Aropax appears.

I've also outlined in bold some of the points re suicidality and some re Relative Risks.

It amazes me how a relative few good (and very busy) expert doctors can come up with more information in their 'own time' than drug regulators (like the MHRA and the FDA) and their 'special investigatory committees' can - even though they have the power to find out the facts from the pharma industry, its THEIR JOB and doing so to protect the public is THEIR RESPONSIBILITY!

"CHEERS" pesticide testing targets black American infants.

"Statement by Vera Hassner Sharav
Founder & President, AHRP
April 1, 2005
Anthrax Band Reunion Press Conference
New York City

My name is Vera Hassner Sharav, and I am president of The Alliance for Human Research Protection: a national human rights organization that exposes unethical research practices which undermine the dignity, rights, and safety of human subjects.

In 1947, an American military tribunal sat in judgment of the Nazi doctors at Nuremberg, and laid down ten essential principles that define "permissible medical experiments" in a civilized society. Those principles are enshrined in the Nuremberg Code which is the cornerstone of all medical research ethics. The nations of the world adopted the Code as a safeguard to prevent future medical atrocities.

The foremost ethical principle of the Nuremberg Code is the right to voluntary, informed consent by a legally competent individual.

Informed consent is "absolutely essential" for all research involving human subjects.

The right to say no to medical experiments is an inalienable human right - it is what sets humans apart from lab rats and guinea pigs.

We are here to alert you that our government is systematically sidestepping international standards, and changing national research protection policies to accommodate the chemical, pharmaceutical and pesticide industries. Those policy changes threaten the fabric of our society--they affect not only soldiers, they affect children, the disabled, and anyone who is uninformed, powerless, or even temporarily incapacitated.

The FDA has waived individual consent for emergency research, substituting so-called "community consent" - a clear violation of the Nuremberg Code.

There are many examples of research abuse and violations of informed consent - including an artificial blood experiment being conducted today on unconscious trauma patients. The safety of the artificial blood has not been proven. In an earlier experiment testing artificial blood, 43 people died.

In another experiment, 861 patients with severe lung injury were enrolled - without their consent - in a government-sponsored experiment that resulted in the death of at least 47 people who would have otherwise lived.

Infants and children have suffered; some have died in government sponsored experiments that tested drugs and vaccines, including multiple AIDS drug cocktails. Even though some of these drugs were known to have lethal side effects, at least 100 children in NYC foster care, were used as human guinea pigs in 36 experiments testing the safety of toxic experimental AIDS drugs.

Parents who refused to give their permission were threatened with loss of custody. And if the children refused to comply or were unable to swallow, a plastic feeding tube was surgically inserted in their stomach to ensure compliance.

The US government has recently put its seal of approval on human pesticide experiments - which violate the standards of "permissible medical experiments."

The EPA, in collaboration with the American Chemical Council is targeting 60 African-American babies in Duval County, Georgia to test the effects of pesticides in infants and children--even though exposure to pesticides increases the risk of cancer, and can damage children's mental development and their immune system.

The experiment is called CHEERS (Children's environmental exposure research study). The government is offering parents $970, plus a video camera, blank tapes and a VCR as inducements to permit their children to be used as human guinea pigs.

The administration's nominee to head the EPA, Stephen Johnson, is a strong supporter of human pesticide experiments, including the CHEERS children experiment. In our opinion, anyone who supports human pesticide experiments is not the right choice to head the EPA.

The documented evidence shows that government officials whose agency mission is to protect the public health from harmful drugs, vaccines, and unethical medical research are, in fact, the very agents that have opened the gate to medical atrocities.

Under a new government plan all American children will be screened for presumed mental health problems. Screening will increase the use of mind-altering drugs such as: Prozac, Zoloft, and Paxil--which are so dangerous, they carry a black box warning about an increased risk of violent and suicidal behavior. Support our efforts to stop these travesties. Join AHRP. Learn more by visiting www.ahrp.org

Contact: Vera Sharav
Tel: 212-595-8974 "

END OF ARTICLE.


So why does Bush's regime need to test pesticides/organophosphates on infants?

The dangers and toxicity of pesticides are well documented and have been for a LONG TIME.

Drugging of Children: MotherJones report - Aliah Gleason Story

http://www.motherjones.com/news/feature/2005/05/medicating_aliah.html

Medicating Aliah

When state mental health officials fall under the influence of Big Pharma, the burden falls on captive patients. Like this 13-year-old girl.

By Rob Waters

May/June 2005 Issue




ALIAH GLEASON IS A BIG, lively girl with a round face, a quick wit, and a sharp tongue. She's 13 and in eighth grade at Dessau Middle School in Pflugerville, Texas, an Austin suburb, but could pass for several years older. She is the second of four daughters of Calvin and Anaka Gleason, an African American couple who run a struggling business taking people on casino bus trips.

In the early part of seventh grade, Aliah was a B and C student who "got in trouble for running my mouth." Sometimes her antics went overboard—like the time she barked at a teacher she thought was ugly. "I was calling this teacher a man because she had a mustache," Aliah recalled over breakfast with her parents at an Austin restaurant.

School officials considered Aliah disruptive, deemed her to have an "oppositional disorder," and placed her in a special education track. Her parents viewed her as a spirited child who was bright but had a tendency to argue and clown. Then one day, psychologists from the University of Texas (UT) visited the school to conduct a mental health screening for sixth- and seventh-grade girls, and Aliah's life took a dramatic turn.

A few weeks later, the Gleasons got a "Dear parents" form letter from the head of the screening program. "You will be glad to know your daughter did not report experiencing a significant level of distress," it said. Not long after, they got a very different phone call from a UT psychologist, who told them Aliah had scored high on a suicide rating and needed further evaluation.

The Gleasons reluctantly agreed to have Aliah see a UT consulting psychiatrist. She concluded Aliah was suicidal but did not hospitalize her, referring her instead to an emergency clinic for further evaluation. Six weeks later, in January 2004, a child-protection worker went to Aliah's school, interviewed her, then summoned Calvin Gleason to the school and told him to take Aliah to Austin State Hospital, a state mental facility.

He refused, and after a heated conversation, she placed Aliah in emergency custody and had a police officer drive her to the hospital.

The Gleasons would not be allowed to see or even speak to their daughter for the next five months, and Aliah would spend a total of nine months in a state psychiatric hospital and residential treatment facilities.

While in the hospital, she was placed in restraints more than 26 times and medicated—against her will and without her parents' consent—with at least 12 different psychiatric drugs, many of them simultaneously.

On her second day at the state hospital, Aliah says she was told to take a pill to "help my mood swings." She refused and hid under her bed. She says staff members pulled her out by her legs, then told her if she took her medication, she'd be able to go home sooner. She took it.

On another occasion, she "cheeked" a pill and later tossed it into the garbage. She says that after staff members found it, five of them came to her room, one holding a needle. "I started struggling, and they held my head down and shot me in the butt," she says. "Then they left and I lay in my bed crying."

What, if anything, was wrong with Aliah remains cloudy. Court documents and medical records indicate that she would say she was suicidal or that her father beat her, and then she would recant. (Her attorney attributes such statements to the high dosages of psychotropic drugs she was forcibly put on.) Her clinical diagnosis was just as changeable. During two months at Austin State Hospital, Aliah was diagnosed with "depressive disorder not otherwise specified," "mood disorder not otherwise specified with psychotic features," and "major depression with psychotic features."

In addition to the antidepressants Zoloft, Celexa, Lexapro, and Desyrel, as well as Ativan, an antianxiety drug, Aliah was given two newer drugs known as "atypical antipsychotics"—Geodon and Abilify—plus an older antipsychotic, Haldol. She was also given the anticonvulsants Trileptal and Depakote—though she was not suffering from a seizure disorder—and Cogentin, an anti-Parkinson's drug also used to control the side effects of antipsychotic drugs. At the time of her transfer to a residential facility, she was on five different medications, and once there, she was put on still another atypical—Risperdal.

The case of Aliah Gleason raises troubling—and long-standing—questions about the coercive uses of psychiatric medications in Texas and elsewhere. But especially because Aliah lives in Texas, and because her commitment was involuntary, she became vulnerable to an even further hazard: aggressive drug regimens that feature new and controversial drugs—regimens that are promoted by drug companies, mandated by state governments, and imposed on captive patient populations with no say over what's prescribed to them.

In the past, drug companies sold their new products to doctors through ads and articles in medical journals or, in recent years, by wooing consumers directly through television and magazine advertising. Starting in the mid-1990s, though, the companies also began to focus on a powerful market force: the handful of state officials who govern prescribing for large public systems like state mental hospitals, prisons, and government-funded clinics.

One way drug companies have worked to influence prescribing practices of these public institutions is by funding the implementation of guidelines, or algorithms, that spell out which drugs should be used for different psychiatric conditions, much as other algorithms guide the treatment of diabetes or heart disease. The effort began in the mid-1990s with the creation of TMAP—the Texas Medication Algorithm Project. Put simply, the algorithm called for the newest, most expensive medications to be used first in the treatment of schizophrenia, bipolar disorder, and major depression in adults. Subsequently, the state began developing CMAP, a children's algorithm that is not yet codified by the state legislature. At least nine states have since adopted guidelines similar to TMAP. One such state, Pennsylvania, has been sued by two of its own investigators who claim they were fired after exposing industry's undue influence over state prescribing practices and the resulting inappropriate medicating of patients, particularly children.

Thanks in part to such marketing strategies, sales of the new atypical antipsychotics have soared. Unlike antidepressants—which have been marketed to huge audiences almost as lifestyle drugs—antipsychotics are aimed at a small but growing market: schizophrenics and people with bipolar disorder. Atypicals are profitable because they are as much as 10 times more expensive than the old antipsychotics, such as Haldol. In 2004, atypical antipsychotics were the fourth-highest-grossing class of drugs in the United States, with sales totaling $8.8 billion—$2.4 billion of which was paid for by state Medicaid funds.

At a time when ethical questions are dogging the pharmaceutical industry and algorithm programs in Texas and Pennsylvania, President Bush's New Freedom Commission on Mental Health has lauded TMAP as a "model program" and called for the expanded use of screening programs like the one at Aliah Gleason's middle school. The question now is whose interests do these programs really serve?

Desiderata - Max Ehrmann

Max Ehrmann


Desiderata

Go placidly amid the noise and haste,
and remember what peace there may be in silence.
As far as possible without surrender
be on good terms with all persons.
Speak your truth quietly and clearly;
and listen to others,
even the dull and the ignorant;
they too have their story.

Avoid loud and aggressive persons,
they are vexations to the spirit.
If you compare yourself with others,
you may become vain and bitter;
for always there will be greater and lesser persons than yourself.
Enjoy your achievements as well as your plans.


Keep interested in your own career, however humble;
it is a real possession in the changing fortunes of time.
Exercise caution in your business affairs;
for the world is full of trickery.
But let this not blind you to what virtue there is;
many persons strive for high ideals;
and everywhere life is full of heroism.


Be yourself.
Especially, do not feign affection.
Neither be cynical about love;
for in the face of all aridity and disenchantment
it is as perennial as the grass.


Take kindly the counsel of the years,
gracefully surrendering the things of youth.
Nurture strength of spirit to shield you in sudden misfortune.
But do not distress yourself with dark imaginings.
Many fears are born of fatigue and loneliness.
Beyond a wholesome discipline,
be gentle with yourself.


You are a child of the universe,
no less than the trees and the stars;
you have a right to be here.
And whether or not it is clear to you,
no doubt the universe is unfolding as it should.


Therefore be at peace with God,
whatever you conceive Him to be,
and whatever your labors and aspirations,
in the noisy confusion of life keep peace with your soul.


With all its sham, drudgery, and broken dreams,
it is still a beautiful world.
Be cheerful.
Strive to be happy.


Max Ehrmann, Desiderata, Copyright 1952.

Paul Flynn MP "More Fiddled Pharma Results"

Paul Flynn MP (UK) site(

"More Fiddled Pharma Results

Researchers ignore 'inconvenient' drug trial results By Robert Matthews, Science Correspondent The Sunday Telegraph (UK national newspaper) (Filed: 30/05/2004)

Scientists are routinely cherry-picking the results of clinical trials so that they can present the findings that they want, a study by academics at Oxford University shows. The research, which assessed the published results of more than 100cientific trials, also found that inconvenient findings were often not disclosed to the public.

In several cases, the stated purpose of the trial was altered as it progressed so that acceptable findings, rather than inconvenient results, could be published. The manipulation, which contravenes official guidelines on reporting medical research, was uncovered by academics at Oxford University, led by Dr An-Wen Chan, a researcher on clinical medicine.

Dr Chan warned that the findings called into question the National Health Service's evidence-based approach to developing medicine, in which clinical trials are used to determine whether to introduce new treatments.

"The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols," said the team. "

Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention."

Suspicion about the reliability of published medical research, which has been increasing for some time, has been prompted by concern over the influence of drugs-company funding.

A recent study at the Yale School of Medicine showed that 80 per cent of clinical trials backed by drug manufacturers reported positive findings - compared to 50 per cent of those carried out by independent academics. Other studies have shown evidence of a bias against unclear trial results being published in academic journals, and of positive results being repeatedly published - giving the impression that a drug is far more effective than it really is.

The Oxford team's findings, which are published in the latest edition of the Journal of the American Medical Association, are based on an assessment of the original paperwork from more than 100 trials of medical techniques ranging from drug to surgical methods. It compared the supposed aims of the trials with what was finally published and found that in half of the studies, results that would have given a more accurate picture of the effectiveness of the treatment being studied were not fully reported.

In almost two-thirds of these cases, the results omitted concerns over potential harmful effects. Independent researchers were just as prone to bias as those funded by industry. Crucial information, from the intensity of pain to survival rates, was either downgraded in importance or omitted from the published report. In more than half of the trials examined, discrepancies were found between the original aims of the study and those finally reported.

Such changes are in direct contravention of official guidelines on trials. Despite this, not one trial report made clear that the original aims of the research had been altered. When contacted by the Oxford team, almost 90 per cent of the research teams denied that they had failed to report everything, despite evidence to the contrary.

Dr Doug Altman, a professor of statistics in medicine at the Institute of Health Sciences, Oxford, and a member of the research team, said: "All trials should be published honestly and transparently, and this study shows neither is happening. The most worrying aspect is that over 50 per cent of the outcomes found by the trials weren't reported - and so can't be included in the reviews used to assess different treatments. This has serious implications for the reliability of the recommendations made to the National Health Service."

Dr Altman said that there was no evidence that the cherry-picking of results was because of fraudulent intent, and claimed instead that it was because of pressure from journals to present findings on medical advances.

"There is a lot of pressure from medical journals to publish positive findings and to keep the length of papers down, which can lead to negative results being omitted," he said. Dr Altman added, however, that this did not explain why the original design aims of trials were altered so often. He called for the original design aims and findings of all clinical trials to be made publicly available, to prevent changes going undetected.

Other leading authorities on medical research expressed dismay at the findings of the study. Sir Iain Chalmers, the founder of the Cochrane Collaboration, which publishes reviews of clinical evidence for doctors worldwide said: "In the days when no one paid any attention to scientific evidence, this would not have been a worry, but now people are investing huge amounts in research, these skeletons are coming out of the cupboard."

The Association of the British Pharmaceutical Industry said that it agreed that researchers had a duty to reveal any changes made to the original trial design, and supported full disclosure - but only when the trials had been completed. Richard Ley, a spokesman for the association, said:

"There can be commercially confidential information in trial protocols, and with a new drug costing £500 million and 10 years to produce, that is an important issue."

A spokesman for the National Institute for Clinical Excellence, which provides the NHS with recommendations on best practice, said that it was already taking steps to avoid the problems of biased reporting of results.

"Our appraisal committee considers all of the evidence - including an independent systematic review of the manufacturer's submission - and other literature, which is designed to take into account possible bias in the reporting of trial outcomes." top home search"

"Bush's Brave New World' by Sheldon Richman

This seems a fairly apt article to start with:


"The Future of Freedom Foundation
03/31/05
Bush's Brave New World by Sheldon Richman


October 07, 2004

President Bush's little-publicized New Freedom Commission on Mental Health has proposed comprehensive mental-illness screening for all Americans. If this proposal is carried out, which is Bush's intention, no adult or child will be safe from intrusive probing by "experts," backed by drug companies, who believe that mental illness is woefully underdiagnosed and therefore that many millions of people ought to be taking powerful and expensive psychiatric drugs. Schools and doctors' offices will become quasi-psychiatric monitoring stations.

Rep. Ron Paul of Texas tried to forbid the federal government from funding mental-health screening, but the House turned down his amendment to the appropriations bill for the Department of Health and Human Services. Paul, a physician, said the program was a usurpation of parental rights, pointing out that parents can already be charged with child abuse for refusing to give their children Ritalin for alleged attention deficit hyperactivity disorder. He said, "Psychotropic drugs are increasingly prescribed for children who show nothing more than children's typical rambunctious behavior. Many children have suffered harmful effects from these drugs."

Another physician, Karen Effrem, also opposes the plan: "Universal mental-health screening and the drugging of children, as recommended by the New Freedom Commission, needs to be stopped so that many thousands if not millions of children will be saved from receiving stigmatizing diagnoses that would follow them for the rest of their lives. America's school children should not be medicated by expensive, ineffective, and dangerous medications based on vague and dubious diagnoses."

People wrongly assume that psychiatric diagnoses are like medical diagnoses. They're not. Medical diagnoses are ultimately based on objective biological evidence. Psychiatric diagnoses, as retired psychiatry professor Thomas Szasz shows, are based on what people say and do. This means that such diagnoses are moral and political, not medical, judgments. It begs the question to say that brain science is still in its infancy: Why is one kind of behavior interpreted as a sign of mental or brain disease but not another kind? Besides, Szasz writes, behavior has reasons not causes. That principle is at the very core of what we mean by personhood. (Brain-scan technology cannot refute this principle because it does not identify causes of behavior. Correlation is not causation.)

Thus the New Freedom Commission recommendation that everyone be screened for mental illness whenever he goes to the doctor and that children be monitored for mental illness in the government's schools is simply a plan to stigmatize people for "inappropriate" behavior and speech. It is also a plan for the widespread drugging of adults and children under government supervision. Besides the Huxleyian aspects of this idea, there is also reason to fear improper influence by drug companies.

Allen Jones, formerly of the Pennsylvania Office of Inspector General, revealed that a similar program was started in his state after drug companies curried favor with state officials. According to the British Medical Journal, "In July 2002 Mr Jones was appointed lead investigator when he uncovered evidence of payments into an off-the-books account. The account, earmarked for 'educational grants' was funded in large part by Pfizer and Janssen Pharmaceuticals. Payments were made from the account to state employees who developed formulary guidelines recommending expensive new drugs over older, cheaper drugs with proven track records. One of the recommended drugs was Janssen's ... Risperdal - a drug that has recently been found to have potentially lethal side effects."

In a statement last January, Jones said, "The industry was influencing state officials with trips, perks, lavish meals, transportation to and first-class accommodations in major cities. Some state employees were paid honorariums of up to $2,000 for speaking in their official capacities at drug-company-sponsored events."

Jones was relieved of his duties after blowing the whistle. In court papers challenging the state's move he said the government was attempting to "cover up, discourage, and limit any investigations or oversight into the corrupt practices of large drug companies and corrupt public officials who have acted with them."

The New Freedom Commission has gotten little publicity. One hopes that as Americans learn about its ominous proposal for wholesale mental-illness screening and psychiatric drugging of them and their children, they will vehemently object.

Benedict LaRosa is a historian and writer and serves as a policy advisor to The Future of Freedom Foundation
Bart Frazier is program director at The Future of Freedom Foundation.
Sheldon Richman is senior fellow at The Future of Freedom Foundation in Fairfax, Va., author of Tethered Citizens: Time to Repeal the Welfare State, and editor of The Freeman magazine.
Mr. Hornberger is founder and president of The Future of Freedom Foundation. Send him email.
The Future of Freedom Foundation. "

Birth of Pharmapolitical Future

The Pharma Corruption Blog.

This blog has just started. Designed to expose Pharmaceutical Corruption and so plenty of material to post here, but at the moment - just working out how to use the blog.

Trying it out in this message.