Pharma Corruption

The pharma-political-psychiatric 'Brave New World', a world on mind-altering drugs. Drugs whose 'safety' and 'efficacy' are based on lies, deception and corruption. A 'Brave New World' on drugs that kill. A world of Violence and Suicide. A world of gross violation of Human Rights. SAY "NO!" TO THE PSYCHOACTIVE DRUGGING OF OUR CHILDREN!

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Location: British Indian Ocean Territory

Monday, September 04, 2006

Summer time, and tbe living is - Camp Meds for Kids

http://seattletimes.nwsource.com/html/nationworld/2003130146_campmed1...

Camp fixtures: bugs, s'mores and pills
By Jane Gross

The New York Times

BURLINGHAM, N.Y. The breakfast buffet at Camp Echo starts at a picnic table where children jostle for their morning medications: Zoloft for depression, Abilify for bipolar disorder, guanfacine for twitchy eyes and a host of medications for attention-deficit disorder.

A quick gulp of water, a greeting from the nurse, and the youngsters move on to the next table for orange juice, Special K and chocolate-chip pancakes. The dispensing of pills and pancakes is over in minutes.

The medication lines like the one at Camp Echo were unheard of a generation ago but have become fixtures at residential camps across the country. Between one-quarter and one-half of the youngsters at any given summer camp take daily prescription medications, experts say. Allergy and asthma drugs top the list, but behavior-management and psychiatric medications are now so common that nurses who dispense them no longer try to avoid stigma by pretending they are vitamins.

"All my best friends take something," said David Ehrenreich, 12, who has Tourette's syndrome yet feels at home here because boys with hyperactivity, mood disorders, learning disabilities and facial tics line up just as he does for their daily meds.

With campers far from home, family and pediatricians, the job of safely and efficiently dispensing medications falls to infirmaries and nurses whose stock in trade used to be calamine lotion and cough syrup. Three times a day, at mealtimes, is the norm, with some campers also requiring a sleep aid at bedtime to counteract the effect of their daytime medications.

"This is the American standard now," said Rodger Popkin, an owner of Blue Stars Camps in Hendersonville, N.C. "It's not limited by education level, race, socioeconomics, geography, gender or any of those filters."

Peg Smith, the chief executive officer of the American Camp Association, a trade group with 2,600 member camps and 3 million campers, says about a quarter of the children at its camps are medicated for attention-deficit disorder, psychiatric problems or mood disorders.

Many parents welcome the anonymity that comes when a lot of children take this, that or the other drug, so none stands out from the crowd.

"It's nobody's business who's taking what," said one parent of an Echo camper who is medicated for attention-deficit disorder. The parent asked not to be named for privacy reasons. "It could be an allergy pill. The way they do it now, he feels comfortable. He just goes up with everybody else, gets it and then carries on with his day."

Year-round regimen

Increasingly popular is a service offered by a private company called CampMeds, which provides a summer's worth of prepackaged pills to 6,000 children at 100 camps. The company's founder, Dana Godel, said 40 percent of the children regularly took one or more prescription medications, compared with 30 percent four years ago. Eight percent used attention-deficit medications last year; 5 percent took psychiatric drugs.

Borrowing technology developed for nursing homes, CampMeds distributes pills in shrink-wrapped packets marked with a name, date and time. Camp nurses tear each packet and dispense, sparing them the labor-intensive task of counting pills and reducing the risk of error, and thus, liability.

The proliferation of children on stimulants for attention-deficit disorder, antidepressants or antipsychotic drugs, or on cocktails of all three, is not peculiar to the camp setting. Rather, it is the extension of an increasingly common year-round regimen that has also had an impact on schools, although a lesser one, since most medications are taken at home.

Exacting diagnoses and proper treatments enable some children to go to camp who otherwise could not function in that environment, said Dr. David Fassler, a child-and-adolescent psychiatrist and a professor at the University of Vermont College of Medicine.

Fassler said that children with one behavioral or mood disorder often "have a second or even a third diagnosis." A child with attention-deficit disorder may also be depressed and anxious, he said, a combination of symptoms that can make such children pariahs in the close quarters of a summer-camp cabin without the proper combination of remedies.

Too many meds?

Some camp owners question the trend, however. Popkin, the camp owner in North Carolina, is among them. "It's universal, and nobody really knows if it's appropriate or safe," he said.

And many experts say family doctors who do not have expertise in psychopharmacology sometimes prescribe drugs for anxiety disorders and depression to children without rigorous evaluation, just as they do for adults.



"There is no doubt that kids are more medicated than they used to be," said Dr. Edward Walton, an assistant professor of pediatrics at the University of Michigan and an expert on camp medicine for the American Academy of Pediatrics. "And we know that the people prescribing these drugs are not that precise about diagnosis. So the percentage of kids on these meds is probably higher than it needs to be."

A few medicines growing in popularity, like Abilify and Risperdal, are used for a grab bag of mood disorders. But according to the Physicians' Desk Reference, the encyclopedia of prescription medications, they can have troublesome side effects in children and teenagers, including elevated blood sugar or a tendency toward heat exhaustion, which requires vigilance by counselors during long, hot days.

Some doctors, nurses and camp directors are uneasy about giving children so-called off-label drugs like Lexapro and Luvox. Such medications are used for depression and anxiety, and have been tested only on adults but can legally be prescribed to children. Clonidine is approved as a medication for high blood pressure but is routinely used for behavioral and emotional problems in children.

"That doesn't mean they are inappropriate or unsafe," Fassler said, adding that camp nurses should be able to call the physician when they have questions, but that not all parents welcome that.

Few camp directors risk discussions with parents about behavioral or psychiatric drugs. "We don't make these judgments for families," said Marla Coleman, an owner of Camp Echo and a past president of the American Camp Association.

Trial, error, fears

Figuring out how to distribute all this medicine has taken some trial and error, beginning with supervision by the nurses, who watch the children take their pills.

Some camps do it in the mess hall, citing informality to put campers at ease and the convenience of having everyone assembled in one place.

Other camps prefer the infirmary, to provide more privacy. Camp Pontiac in Copake, N.Y., built a special medication wing with its own entrance and a porch where campers wait their turn.

In Fishkill, N.Y., at a Fresh Air Fund camp for underprivileged children, one nurse in the infirmary deals with bug bites and skinned knees and the other dispenses Strattera and Zoloft, the first for attention-deficit disorder and the second for depression, social anxiety or obsessive-compulsive disorder.

The potential for harmful drug interactions is compounded by the widespread use of allergy and asthma medications. Tofranil, an antidepressant for adults that is used for bed-wetting in children, is not recommended in combination with Allegra, for seasonal allergies; Advair, an asthma drug; or epinephrine, the injectable antidote to deadly allergic reactions to bee stings, insect bites and certain foods.

Despite a tenfold increase in childhood allergies over the past decade, some camp doctors think daily medication is overused. The owners of Camp Pontiac, Ken and Rick Etra, brothers who are ear, nose and throat doctors, urge parents to forgo prescription remedies for seasonal allergies when occasional over-the-counter antihistamines are sufficient. Their summer camp does not overlap with the height of the pollen and grass season, the Etras say.

They also discourage bed-wetting medications, which can leave a youngster groggy.

"They don't pee, but they're zombies," said Mimi Burcham, Pontiac's head nurse. Instead, camp directors train counselors to wake certain children at midnight for a trip to the bathroom and replace soiled linens with identical sheets to avoid embarrassment.

CampMeds charges $40 per child for any length of stay or for any regimen, a cost that most camps pass along to families. The Fresh Air Fund camps do not use CampMeds, but not because of cost, said Jenny Morgenthau, the fund's executive director. Rather, Morgenthau said, many of the families are too disorganized some in shelters or in prisons to do the preparatory paperwork.

So Fresh Air's campers arrive with an array of unmarked bags and bottles that cannot be used under state regulations, and without some of their essential medications. Susan Powers and Leticia Diaz, who run the infirmary at the girls' camp, are accustomed to children bringing their brother's expired asthma inhaler or their grandmother's sleeping pills in a perfume bottle. Sometimes the medications are missing because they have been sold on the street or used by adults, Powers and Diaz said. It takes a few days to unscramble.

The nurses at high-end camps have the opposite problem, with parents who try to involve themselves in all aspects of their children's lives with ceaseless efforts to help. That mind-set has the potential to lead to overmedication, many camp owners and doctors say.

Burcham, a special-education nurse during the school year, said she often worries about her unfamiliarity with some of the drugs. She often turns to the Physicians' Desk Reference for guidance, or sometimes calls her father, a psychiatrist.

Unpacking the shipment of medicine at Pontiac in mid-June, she tried to make sense of a packet from CampMeds for an 11-year-old who, for the first time, would be taking Concerta, for attention-deficit disorder, along with clonidine and Wellbutrin, both mood-disorder drugs.

"I'm not a specialist, and that's very disturbing sometimes," Burcham said. "How do I know if we're really getting it right?"

Then she carefully placed the medications in a plastic bin marked with the camper's name. "

Strattera - From Failed Antidepressant to New Drug for ADHD

An investigative journalist has been chasing up some rather worrying matters about Strattera, which proved to be a 'failed' antidepressant and so was repackaged as a new drug for ADHD to recover profits at the risks of children.

http://www.24-7pressrelease.com/view_press_release.php?rID=12752

"Eli Lilly withheld disastrous effects of Strattera from parents and children

The wording of the parent and children information in an ongoing clinical trial of Strattera has been revealed. Eli Lilly withheld the drug's disastrous effects in order to get children to participate in the study.


/24-7PressRelease/ - HAGERSTEN, SWEDEN, April 05, 2006 - The "ADHD medication" Strattera is not approved in Sweden. Eli Lilly decided to do a one-year clinical trial of the drug on children. The purpose of the study was to get Strattera approved by the Medical Products Agency (MPA). The company hired the psychiatric authority Bjorn Kadesjö to lead the trial.

The 100 participating children and their parents needed information about the adverse effects of the drug in order to sign the consent form. They thought they got it. They did not.

Eli Lilly deliberately withheld information about disastrous effects of Strattera - information which could have made the parents and children want to withdraw from the study; information which could have made the Regional Ethical Review Board want to disapprove the application; information which could "disturb" the result of the trial.

The "updated" information given to parents and children about adverse effects was from January 31, 2005. The only serious adverse effect mentioned was liver injury in very rare cases.

But documents now made public show that Eli Lilly knew about several serious effects from Strattera at that time.

Take the FDA report Psychiatric Adverse Events Associated with Drug Treatment of ADHD: Review of Postmarketing Safety Data, released for the FDA Pediatric Advisory Committee meeting, March 22. It says that Eli Lilly (and other pharmaceutical companies) were asked to provide information about a) signs and/or symptoms of psychosis or mania; b) suicidal ideation and behavior; c) aggression and violent behavior, (for Strattera for the period November 2002 - June 2005). In that period Lilly had received 350 reports of psychosis or mania, 900 reports of aggression and violent behavior and 400 reports of suicidality. In a Preliminary Assessment Report from December 2005, written by the British medical regulatory agency MHRA, it is mentioned that Lilly from November 2002 to September 2005 had received 766 reports of heart disorders connected to the use of Strattera. (It should be noted that credible estimates of the percent of adverse reactions that are reported range from 1-10%.)

It is certainly not so that Eli Lilly had received these reports in the period February - June 2005. Almost all of reports had been received in the foregoing 26-month period and only a minor part in the 5 month up to June 2005.

This means that Eli Lilly deliberately withheld Strattera's disastrous effects of psychosis and mania, aggression and violent behavior, suicidality and heart disorder, in the information to parents and children in the clinical trial. "



http://www.24-7pressrelease.com/view_press_release.php?rID=11901

MHRA forbids Sweden to reveal Strattera suicide data

The British Medicines and Healthcare products Regulatory Agency (MHRA) has forbidden Swedish authorities to reveal Strattera suicide data. A release in Sweden of data about suicides and suicide attempts from Eli Lilly's Strattera is said to hurt the relations between the two countries.


/24-7PressRelease/ - SWEDEN - March 10, 2006 - Data about the harmful effects from the ADHD drug Strattera were revealed in a document from 9 December 2005, written by the British MHRA and sent to the Swedish MPA (Medical Products Agency). The information was gotten as a result of FOIA-requests, and released by court order.

The document told about 130 reports of suicidality in one month from treatment with Strattera. It told about 766 spontaneous reports of cardiac disorders and 172 of liver injury, and about 20 completed suicides. The 130 cases of suicidal and self-injurious behaviour were reported September 23 - October 25, 2005.

The main part of the information was classified and not released. So was, for example, the full assessment of all data about suicidality withheld from the public. That review - on which MHRA based their conclusions - was made by the manufacturer, Eli Lilly, and was named Annex 4 to the report. It would of course be of tremendous value for independent researchers to read how Lilly has treated the statistical data, but this has not been possible.

And now MHRA has forbidden Sweden to release Lilly's review. In a decision made by the Swedish MPA, as a result of a new FOIA-request, it is written that contact has been taken with the British authority MHRA and that the release of Lilly's suicide review would hurt the relations between the two countries! Thus the review cannot be released.

The MHRA, as well as FDA and other national medical agencies are supposed to be "watchdogs", supposed to protect the public from harmful effects of dangerous drugs. That the MHRA now gives directive to other countries to hide the information about Strattera suicide data is a big medical scandal.

All information about the harmful effects of this psychiatric drug should now be made public by the medical authorities and an impartial evaluation of the data should be done. Psychiatrist should no longer be allowed to prescribe poisonous drugs to normal children; children who do not have any objective abnormality but whose behaviour are deemed inappropriate."




http://www.24-7pressrelease.com/view_press_release.php?rID=16662

Strattera - 10,988 adverse "psychiatric reactions" reported in less than three years

In less than three years 10,988 adverse "psychiatric reactions" have been reported to Eli Lilly for the ADHD drug Strattera. This is revealed in a document treated as a "state secret" by the British and Swedish medical agencies.

/24-7PressRelease/ - HAGERSTEN, SWEDEN, August 01, 2006 - The document, Psychiatric Adverse Events including Cumulative review of spontaneous reports of suicidal and self-injurious behaviour, is an attachment to an unpublished report about Strattera from the British Medicines and Healthcare products Regulatory Agency (MHRA), January 2006.

The attachment, mentioning the 10,988 "psychiatric reactions", also gives a good insight into how psychiatric drugs and drug cocktails are killing children and adults, and how psychiatric diagnoses are used to hide the harmful effects of drugs.

A court in Sweden has recently ordered the document to be made public.

This was done after the Swedish Medical Products Agency (MPA) and the British MHRA in their response to FOIA [FREEDOM OF INFORMATION ACT] requests had treated this document as if it was a "state secret".

In its arguments to the court the Swedish MPA even said that issuance of it would hurt the relations between Sweden and UK. Neither the British National Institute for Health and Clinical Excellence (NICE), responsible for "guidance on the appropriate treatment", being in possession of the document, was willing to reveal the data in it. NICE said in an answer to a FOIA-request that the document was "received in confidence and disclosure of that information would amount to an actionable breach of confidence".

These agencies, responsible for protecting the public from harmful drugs and for "appropriate treatment", consider a document reviewing the "suicidal and self-injurious behaviour" caused by a psychiatric drug in the category of state secrets, and that it would be "an actionable breach of confidence" to let the public know about these data.

But a court in Sweden has made the document public. The document consists mainly of Eli Lilly's review of the 431 cases of suicidal and self-injurious behaviour reported for Strattera from November 2002 up to October 2005. 130 of these reports were submitted in one month (October 2005), after the warnings were issued in September that Strattera increased the risk for suicidality.

Lilly's review is an excellent example of how to explain away suicides, suicide attempts and suicide ideation caused by psychiatric drugs - and of how the assessing medical agency then buys these explanations.

It can be seen in the review that children and adolescents in many cases are getting psychiatric drug cocktails - Strattera together with antidepressant SSRI drugs (as Zoloft and Prozac) and antipsychotic drugs (as Risperidone and Zyprexa). The reason for the adding of more drugs to the first one, is that one psychiatric drug's harmful effect - according to the psychiatric ideology - is seen as yet another "psychiatric disorder", to be treated with yet another mind altering (poisonous) drug. And so on.

The alleged psychiatric brain disorder ADHD (without any objective abnormality) is NOT associated with suicidal thoughts in its list of "symptoms". However as the reports of suicidal behaviour from "treatment" with Strattera kept coming in, Eli Lilly had to connect depression and suicidal behaviour with ADHD, to exonerate the drug and blame it on the children's "underlying condition". For this purpose Eli Lilly claimed in its submission to the FDA in September 2005: "Depression is present in up to 40% ...of ADHD adolescents and children."

It is very convenient for drug companies that psychiatrists are adding more poisonous drugs to the first one when its harmful effects are showing up. No single drug can then be blamed for the death of children.

It is even more convenient to blame the harmful effects of a drug on a (presumed) "underlying condition". This is what Eli Lilly and the psychiatric experts at the MHRA are doing when they in cases of suicidal behaviour in connection with Strattera find "confounding factors" present. No matter how obvious the case of poisoning the conclusions from the medical agency become (at best): "the possibility that atomoxetine [Strattera] may have exacerbated the individuals underlying condition in these cases cannot be excluded."

In its report about Strattera (January 2006) the MHRA talks about "the large number of psychiatric reactions". It says the agency in September 2005, due to this large number of harmful effects, had requested Eli Lilly "to perform a cumulative review of all psychiatric disorders reported for atomoxetine [Strattera]".

In the attachment, containing the review by Eli Lilly of suicidal behaviour, no review of "the large number of psychiatric reactions" can be found. What can be found is the number of reported reactions (up to September 2005): 10,988 adverse "psychiatric reactions" described in 6,751 reports. Example of reactions: The two categories aggression and anger are reported in 1117 cases, abnormal behaviour in 989 cases, and homicidal ideation in 19 cases.

The MHRA has still not let the public know any details about this "large number of psychiatric reactions". Neither has the agency let the public know the updated figures for suicidal behaviour in connection with Strattera.


Janne Larsson
writer from Sweden - investigating psychiatry