ADHD: Eli Lilly's Strattera - Swedish Test Disastrous
An FDA advisory panel recently recommended, that stimulant drugs such as Ritalin, prescribed for Attention Deficit (ADHD) should carry strong warnings after reports of strokes and heart problems, including 25 sudden deaths, surfaced.
According to Evelyn Pringle, Attention Deficit Disorder, which amounts to little more than a list of behaviors, was voted into existence in 1980 as a mental illness by the American Psychiatric Association. It was then included in the psychiatric billing Bible known as the Diagnostic & Statistical Manual for Mental Disorders, DSM. In 1987, an H was added to the label and the illness became, "Attention Deficit Hyperactivity Disorder." A few years later, ADHD was classified as a disability and a cash incentive program was initiated for low-income families which could get $450 a month for each child diagnosed with the disorder, and the cost of treatment and medication for low-income children would be covered by Medicaid. (see ADHD Drugs - Cash Cow For Pharma)
Since then, the sale of ADHD medications has been on a strong uptrend - but many parents got wary of stimulants, which are really mind altering drugs. The recent recommendation for strong warnings comes late, as is normal FDA practice. The motto of the US agency that is charged with assuring drug safety seems to be "approve now - worry about side effects later".
Eli Lilly, the manufacturer of antidepressant Strattera proposed a study in Sweden to approve the drug for wide use. The study failed miserably, reports Janne Olov Larsson, a Swedish investigator.
Meanwhile, a discussion paper of the British Medicines and Healthcare products Regulatory Agency (MHRA), obtained through Freedom of Information Request, reveals that there have been 130 reports of suicidality in the UK in just one month - from 23 September to 25 October 2005 - as a consequence of treatment with Strattera. The paper also reveals that in just three years, use of the drug led to 766 spontaneous reports of cardiac disorders and 172 of liver injury, as well as some 20 completed suicides.
Here is a post from Theo's ADHD blog. Theo is a Dutchman living in Sweden, who has been diagnosed with ADHD and who decided to "test drive" Strattera. He is one of 600 experimental patients for the drug to get approved for sale in Sweden. His whole story, a diary type record of how he felt while taking the drug, can be found on his blog.
His latest post:
Newspaper in Sweden & ADHD
Last week a big daily newspaper in Sweden, called AftonBladet has been writing a few articles about Strattera.
The medicine which I have been testing for a little more then a month...
- - -
Eli Lilly’s and Christopher Gillberg’s failed experiment with Strattera
The Swedish Medical Products Agency (MPA) knows that Gillberg’s clinical trial of Strattera is a catastrophe. It has nevertheless been allowed to continue.
The agency does not have the mission to protect the authority of psychiatrists and the profit of pharmaceutical companies – it is supposed to make sure that patients and the public are getting safe and effective medications.
The famous Swedish Professor in Psychiatry Christopher Gillberg is doing a clinical trial for Lilly [1]. They are testing Strattera for adults. Strattera is a failed antidepressant, which Lilly didn’t succeed to get out on the market. It was recycled as an “ADHD medication” [2]. The drug is not approved in Sweden; can only be prescribed after special approval from the MPA.
Lilly wants this changed. To get the drug approved would mean a lot of money. Gillberg is also helping Lilly to create a market for Strattera – he says that between 2 and 4 percent of all adults in the country are suffering from a “clinically severe form” of ADHD [3]. There are, in other words, many candidates for Strattera.
Normally pharmaceutical companies only run their trials for around 10 weeks. During this time they often succeed to see a “positive effect” of the pill compared to placebo and no catastrophic harmful effects. This is usually enough to get the drug through the approval procedure at the medical agency. If the trials are done longer the “positive effect” is very likely to completely vanish and more harmful effects are showing up. Not even the most “customer-oriented” agency could then approve the drug [4].
So one must say it was a pretty bold step by Lilly & Gillberg to apply for a 'long-term' clinical trial of Strattera on 40 adults – the trial should last for a year [5].
The MPA thought there should be a control group of 20 persons who got placebo, to be compared with the group of 20 who got Strattera. This should be of “more scientific value”, the agency thought. But Lilly did not agree [1]. So it ended up with 40 adults “with ADHD” who should get Strattera during a year.
Bruno Hägglöf, Professor in Psychiatry – who also is a member of the Lilly Strattera Advisory Board [6] – marketed the new pill in an excellent way on national TV in the end of 2004 [7]. A bottle of Strattera was shown, with the name Eli Lilly prominently displayed, and at the same time Professor Hägglöf said: “There are persons who need to take this type of medication all their life…” And Gillberg, in his turn, wrote in the application for the trial: “The treatment of AD/HD is in most of the cases ongoing for many years” [5]. The idea was that treatment with Strattera should be almost life-long – and Lilly, of course, had no real objections to this.
But, as MPA knows, the actual effects were not at all good for the test persons involved – the persons who should test Strattera for a year.
First of all Lilly/Gillberg did not succeed to recruit 40 persons to the study – a very strange circumstance considering the fact that so much has been written in newspaper articles about the impossibility for adults “with ADHD” to get treatment.
Only 20 persons got enrolled in the trial. And what happened to them?
Ten (10) persons “disappeared” – 3 with the given reason that the drug did not have any effect, 2 never came to their next visits, 1 patient ended without any stated reason – and 4 never got started! [8]
Of the 10 remaining, 5 patients 'had to be taken out of the trial' due to harmful effects: 1 patient had to be taken out due to liver problems, 2 due to aggressiveness/hostility and 2 due to depression. We can in Gillberg’s report also read: “One pat[ient] has completed the whole study.” And in addition to this one patient, can we read, there are four (4) who still have not fallen off [9].
For sure this must be considered a catastrophe?
The result, that 10 persons (half of the original patients included) disappeared, cannot, no matter the counting, be considered positive. Especially not if one also considers the fact that 25 percent of the patients were taken out due to harmful effects – and that at last only one (1) patient remained who had completed the whole study (and 4 others who the researchers in some way are trying to complete)!
Despite the above catastrophic results the MPA writes: “OK to continue the study.” [10]
What is the agency trying to do? Is the intention to assist Lilly and Gillberg in the eventual publication of the “positive parts” of this study – and to conceal the rest? Does the agency want to enhance its image even further as a “customer-oriented agency” – and get more applications from the pharmaceutical industry? [11]
The proper course of action now would be that the MPA intervene to close down this failed experiment and to make sure that all details about the catastrophic results are published as soon as possible.
The MPA is after all an agency that should oversee the actions of the pharmaceutical companies – the patients and the public are the real customers of the agency.
janne.olov.larsson@telia.com
writer
Sweden
References:[1] Läkemedelsverket, Beslut, Atomoxetine hydrochloride/LV 139603 den 5 juni 2003. www.jannel.se/refs_strattera_trial/mpa_approval_gillberg_trial.PDF (MPA, Decision, Atomoxetine hydrochloride/LV 139603, June 5, 2003.)
[2] Alliance for Human Research Protection, Recycled drugs: failed antidepressants-- Strattera marketed for ADHD; Cymbalta for incontinence, April 26 2004,
[3] Gillberg, Lecture: ADHD – Facts & Fiction, p. 7, Tromsoe, November 2005,
[4] For example: Marcia Angell (former Editor-in-chief New England Journal of Medicine), The Truth About the Drug Companies, p. 111-113, 2004; Breggin, Antidepressant-Induced Suicidality and Violence: More About Deception than Science, September 14, 2004,
For other examples on how pharmaceutical companies manipulate their clinical trials, see Richard Smith, Medical Journals are an extension of the marketing arm of pharmaceutical companies, Public Library of Science, May 2005.
[5] Gillberg, Ansökan till forskningsetikkommittén vid Göteborgs universitet, 29 november 2002, inkom 14 januari 2003.
Godkännande etikkommitté (med reservation) 25 augusti 2003,
(Gillberg, Application to Ethics Committee; approval from Ethics Committee.)[6] Lilly, Hägglöf, Avtal för konsultation, 11 november 2004,
(Lilly, Hägglöf, Contract for consultation.)[7] TV4, Nyheterna, 9 november 2004. (Channel 4, News.)
[8] Läkemedelsverket, e-postsvar av den 12 december 2005.
(MPA, e-mail December 12, 2005; Parts translated here:
[9] [Gillberg/Råstam/Cederlund, Angående klinisk läkemedelsprövning, 11 oktober 2005, inkom Läkemedelsverket den 13 oktober 2005.
(Gillberg/Råstam/Cederlund, About clinical drug trial, October 11, 2005, Parts translated here:[10] Läkemedelsverket, anteckning, 18 oktober 2005 (längst ner till höger)
(MPA, Note, October 18, 2005, bottom right)[11] Uppsala Nya Tidning, UNT, Svenska läkemedelsverket mest anlitat i Europa, 2 december 2005,
(Article describing that the Swedish MPA is a very popular agency for the pharmaceutical companies – a very customer-oriented agency.)
A later development (January 2008):Strattera - Letter to Professor Kent Woods, Chief Executive of the UK Medicines and Healthcare products Regulatory Agency - MHRA
January 2, 2008
The ADHD drug Strattera – actions needed now
This letter gives updated information about the harmful effects of the ADHD drug Strattera. It should be of great interest to the MHRA management, considering the promise: "...we take any necessary action to protect the public promptly if there is a problem." [1]
In this case there is definitely a "problem", and it cannot have been properly communicated to the MHRA management. Shouldn't the "problem", that there exists "compelling evidence" that the drug causes serious harmful effects in many children, have been acted upon, if the management had been aware of it?See the full text of this letter in PDF on http://jannel.se/letter.mhra.strattera.jan08.pdf
See also related:Strattera - 130 Reports Of Suicidality In One Month
FDA reports 51 deaths of attention drug patients
FDA To Add Warnings on ADHD drugs--Concerta, Ritalin, Strattera, Adderall
What to do about the ADHD epidemic
Natural Alternatives to Ritalin and Adderall
A great ADHD page: The Block Center
Iron deficiency in children with attention-deficit/hyperactivity disorderEffectiveness of Iron Supplementation in a Young Child With Attention-Deficit/Hyperactivity Disorder
'Natural' cure found for attention deficit disorder
A British millionaire has announced that he may have discovered a way of curing children suffering from the worst form of attention deficit hyperactivity disorder (ADHD) without resorting to drugs.British report finds new risks of ADHD drug
M. ALEXANDER OTTO; The News Tribune
Published: February 20th, 2006 02:30 AM
There are new safety concerns about the Attention Deficit Hyperactivity Disorder drug Strattera, widely used in Europe and the United States. It's already been linked to rare cases of liver damage and suicidal thoughts and behaviors. British authorities have associated Strattera with seizures and a potentially dangerous lengthening of the time between heartbeats, called QT interval prolongation, in a handful of the more than 3.7 million people who have used the drug since it hit the market in November 2002. The warnings are based on an internal report by the British Medicine and Healthcare Products Regulatory Agency, the United Kingdom's equivalent to the U.S. Food and Drug Administration.Sunday Herald: NHS failing to account for number of Scots children prescribed Ritalin
THE number of Scottish children being prescribed drugs such as Ritalin to treat hyperactivity is unknown, despite increasing concerns over a rise in their use. A Sunday Herald investigation has found the majority of health boards are unable to provide details of how many young people are currently on medication to treat attention deficit hyperactivity disorder.The Under Reported Story: ADHD, Stimulants, and the FDA
by Grace E. Jackson, MD - February 18, 2006
Recently, the media minimized a crucial story which deserved to be front page news. Buried among the reports about Danish cartoons, Iraqi bombings, and domestic wiretaps was a recommendation from Food and Drug Administration safety advisors that stimulants, used in the treatment of 3 to 8 million children with ADHD, carry new warnings about the risks of heart disease, stroke, and death. On February 9th 2006, members of the Drug Safety and Risk Management Advisory Committee stunned FDA officials with an 8 to 7 vote which called for the placement of Black Box Warnings on the labels of stimulants. For many industry watchdogs, the recommendation was long overdue.Reviewing ADHD Drugs - FDA Goes Through the Motions
March 12, 2006. By Evelyn Pringle
Some of the top-selling drugs of all time are those prescribed to treat attention deficit disorders. Drug companies have physicians in every field of medicine pushing these medications and dole out millions of dollars worth of free samples each year to make sure they are passed out like candy. A new ADHD drug is set to come on the market that supposedly can keep people awake for days at a time with no problems. Just what we needed, especially for hyper little kids...The Australian: Child drugs linked to heart attack
March 27, 2006
CHILDREN as young as five have suffered strokes, heart attacks, hallucinations and convulsions after taking drugs to treat attention deficit hyperactivity disorder. Documents obtained by The Australian reveal that almost 400 serious adverse reactions have been reported to the Therapeutic Goods Administration, some involving children as young as three. Cases include the sudden death of a seven-year-old, and a five-year-old who suffered a stroke after taking Ritalin. Children also experienced heart palpitations and shortness of breath after taking Dexamphetamine.Eli Lilly withheld disastrous effects of Strattera from parents and children
by Janne Larsson - SwedenStudy: ADHD drugs send thousands to ERs
5/24/2006 - By Linda A. Johnson, Associated Press Writer
Accidental overdoses and side effects from attention deficit drugs likely send thousands of children and adults to emergency rooms, according to the first national estimates of the problem. Scientists at the U.S. Centers for Disease Control and Prevention estimated problems with the stimulant drugs drive nearly 3,100 people to ERs each year. Nearly two-thirds — overdoses and accidental use — could be prevented by parents locking the pills away, the researchers say. Other patients had side effects, including potential cardiac problems such as chest pain, stroke, high blood pressure and fast heart rate.ADHD drugs sent 2,500 to hospital
By Rob Waters, Bloomberg | May 25, 2006
WASHINGTON -- More than 2,500 children went to hospital emergency rooms in 2004 after taking a stimulant used to treat attention deficit hyperactivity disorder, most because of accidental overdoses, a US government report suggests.Strattera side effects
The FDA created MedWatch, a computerized Adverse Event Reporting System (AERS) for post-marketing surveillance of all FDA-approved drugs. Between 2004 and 2006 MedWatch received over 31,000 adverse event reports identifying Strattera (atomoxetine) as the Primary Suspect Drug. These reports cite a total of 1,878 distinct adverse reactions caused by Strattera, ranging from abasia and abdominal discomfort to yellow skin and zinc deficiency. All 1,878 Strattera side effects are listed below in alphabetical order."This is not a complete list of possible side effects." You've heard those words many times, but have you wondered what a COMPLETE list of side effects would look like? Well now you can see for yourself...
Children's suicide attempts raise concerns about ADHD medication
New questions are being raised about the safety of a drug used to treat attention-deficit hyperactivity disorder amid reports that more than 40 Canadian children have attempted suicide after taking it.Health Canada said it received 189 reports of adverse reactions associated with atomoxetine, sold under the name Strattera, from the time it was put on the market in February, 2005, to the end of last year.
The reports included 55 suicide attempts - 41 of which were among children aged 6 to 17, and 12 that were adults between 18 and 45.
December 2008: ADHD drug causes psychosis, hallucinations, mania
The manufacturer, Eli Lilly, has now changed the label for Strattera in Europe to include warnings that Strattera CAUSES "hallucinations, delusional thinking, mania or agitation in children and adolescents without a prior history of psychotic illness or mania … at usual doses".
posted by Sepp Hasslberger on Thursday February 16 2006
updated on Friday December 10 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2006/02/16/adhd_eli_lillys_strattera_swedish_test_disastrous.htm
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October 16, 2004 - Sepp Hasslberger
