By Megan Rauscher
NEW YORK (Reuters Health) - Pooled data from 13 trials indicate that the drug Strattera, known technically as atomoxetine, continues to work well for teens with attention deficit/hyperactivity disorder (ADHD) over at least two years, with no surprise side effects.
In comments to Reuters Health, Dr. Timothy E. Wilens from Massachusetts General Hospital, Boston, said: "Given that atomoxetine is relatively new to the market, our longer term findings in adolescents are reassuring in that the medication continues to be effective without evidence of tolerance and is well tolerated without any unforeseen side effects emerging with chronic use."
Wilens and colleagues note in the Journal of Pediatrics that young children with ADHD are often treated with the stimulant drug Ritalin, but Strattera, a nonstimulant, has appeal for use in older children and adolescents with ADHD; it is dosed once daily, limited abuse potential, and has a long duration of action.
The researchers report on 601 subjects 12 to 18 years of age treated with Strattera in clinical trials. Of these, 219 completed at least 2 years of treatment.
According to the authors, Strattera produced "significant improvement" in ADHD symptoms over the first 3 months of treatment, and symptoms remained improved up to 2 years without the need to up the dose of the drug.
During the 2-year period, 99 subjects (16.5 percent) stopped taking Strattera due to lack of effectiveness and 31 (5.2 percent) discontinued treatment due to side effects.
Mirroring past studies, the most frequently cited reasons for discontinuation were nausea, stomach ache, and headache. There was no evidence of height or weight growth deficits in adolescents treated for up to 2 years with Strattera.
Recently, two cases of liver injury related to Strattera were reported among the roughly 2.4 million patients who have used the drug to date, the team notes. In the current study, there were no "clinically significant" liver function test abnormalities.
"Despite the increasing recognition of the persistence of ADHD into adolescence, there remains a paucity of treatment data in this age group," Wilens and colleagues write. The results of this investigation support the longer-term use of Strattera in adolescents with ADHD, they conclude.
The study was supported by Eli Lilly and Company of Indianapolis, Indiana, maker of Strattera.
SOURCE: Journal of Pediatrics, July 2006."
END OF ARTICLE
Now lets look at Timothy E Wilens statement:
"Given that atomoxetine is relatively new to the market, our longer term findings in adolescents are reassuring in that the medication continues to be effective without evidence of tolerance and is well tolerated without any unforeseen side effects emerging with chronic use."
Firstly, nearly 11,000 adverse effects are hardly "reassuring" unless you don't give a damn about the people suffering from those adverse side effects - a psychiatrist really ought to care about his patients - and, secondly...
"relatively new to the market"? Oh no, its a recycled, old, FAILED, antidepressant. Its the MARKET thats new, not the drug:
"Recycled drugs: failed antidepressants-- Stratera marketed for ADHD; Cymbalta for incontinence
Mon, 26 Apr 2004
A front page article in The Wall Street Journal (excerpt below) provides a roadmap of failed Eli Lilly drugs which the company repackaged for a different condition than the one for which the drugs had been tested in clinical trials, or to expand the market for drugs that don't bring in enough profits when marketed for a particular condition.
The Journal notes: "Lilly has long had a culture that looks at failure as an inevitable part of discovery and encourages scientists to take risks. If a new drug doesn't work out for its intended use, Lilly scientists are taught to look for new uses for a drug."
The Journal lists 8 failed Lilly drugs that were recycled or in the process of being recycled. Among the drugs that bombed are two antidepressants that have been repackaged.
Strattera and Cymbalta are antidepressants of the selective norepinephrine reuptake inhibitor (SNRI) class. In clinical trials Strattera had failed as an antidepressant, but is now a hot-selling drug euphemistically marketed as a "non-stimulant" treatment for ADHD..."
[HOW BAD MUST A DRUG BE AND HOW DIFFICULT IS IT TO BE A "FAILED" ANTIDEPRESSANT in a world where drugs that kill and disable are lied about, pushed, lobbied, bribed and ghostwritten onto the market? It must have been SOME MASSIVE FAILURE to have FAILED as an antidepressant.]
And now lets look at the statement made by Wilens' team:
"Recently, two cases of liver injury related to Strattera were reported among the roughly 2.4 million patients who have used the drug to date, the team notes. In the current study, there were no "clinically significant" liver function test abnormalities. "
And here's where Drug Company Psychiatrists' economy with the truth comes into it.
In the following article you will see there were
172 reports of liver injury,
(not 2 cases, but perhaps the omission of the numbers 1 & 7 was a convenient typo?)
766 spontaneous reports of cardiac disorders
and about 20 completed suicides:
"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.
writer from Sweden - investigating psychiatry "
And finally, looking at this statement from the original article:
"Lilly has long had a culture that looks at failure as an inevitable part of discovery and encourages scientists to take risks."