A long-term clinical trial of Strattera on adults, conducted by Eli Lilly and Professor Christopher Gillberg in Sweden has given a catastrophic result.
The application for the trial was turned in to the Research Ethics Committee at the University of Gothenburg, January 2003. According to the application the trial should test the effect of Strattera on 40 adults for 18 months, to see if a “possible positive effect remains”, and to study “[n]egative side effects short and long term…” (p. 3) [1]
On the question (p. 3) “which risks for harm and discomfort different participants can be subjected to” the answer was: “We estimate that the study does not involve any medical risks for the patient.” And: “Serious side effects are extremely rare.” (p. 4)
But the latest information about the trial says that 24 participants were recruited (of the 40 planned for). 4 persons of the 24 did not start. 20 remained. [2] (The trial is not ended and of course not published in any medical journal.)
The main result: 40 percent (n=8) of the participants had to end the study in advance due to fact that the harmful effects of Strattera were too serious.
The next most important result: 30 percent (n=6) of the participants had to end the study in advance due to fact that Strattera was ineffective.
15 percent (n=3) never came to the next visit or ended on own initiative. (This group should of course be counted to the category above, whereby the part ending due to no effect rises to 45 percent (n=9). (One person ended in advance due to other reasons.)
And: “One patient has completed the study. One patient remains in the study…”
The 40 percent (n=8) taken out of the study due to harmful effects were hit by liver disorder (“increased levels of transamines”, n=1), thyroid disorder (“increased thyroid levels”, n=1), aggressiveness/hostility (n=2), depression (n=3), increased blood pressure (n=1). [2; 3; 4]
In summary Christopher Gillberg and Eli Lilly have shown that the hypothesis did not hold: Strattera’s possible positive effect did not remain; the negative side effects were so serious that 40 percent of the participants had to end the treatment in advance (the medical risks for the patients were too big).
18 of 20 (90 percent) fell out of the study before it was completed and only 1 (possibly 2) will complete the study.
UK is the Reference Member State for Strattera in Europe. The information above warrants a new urgent safety review. I request that the MHRA initiates such a review and investigates this matter fully.
It is a well known fact that disastrous effects of a drug are not showing up in the short-term clinical trials being a requirement for licensing of a drug. Now a long-term clinical trial has been done – or more correctly “tried”. The results of 40 percent of the participants having to end the study in advance due to harmful effects, means that children and adults being subjected to long-term treatment with Strattera – in less well supervised conditions – are in a serious risk situation.
The MHRA should in keeping with its aim to protect public health take immediate actions to investigate this matter. I count on the agency to do so and look forward to an answer saying this the new safety review is started.
Jan Larsson
Writer
Sweden
[1] Gillberg/Kadesjö/Lilly, Ansökan till forskningsetikkommittén vid Göteborgs universitet, 29 november 2002, inkom 14 januari 2003. (Application to the Research Ethics Committee.) http://www.jannel.se/refs_strattera_trial/application_gillberg_strattera_ethics_committee.PDF
[2] Gillberg/Råstam/Cederlund, Angående klinisk läkemedelsprövning (atomoxetine hydrochloride) ref nr: 2002/74152; 25 april 2006. (Communication to the Swedish MPA.)
[3] Gillberg/Råstam/Cederlund, Angående klinisk läkemedelsprövning, 11 oktober 2005, inkom Läkemedelsverket den 13 oktober 2005. (Communication to the Swedish MPA.)
[4] Läkemedelsverket, e-postsvar av den 12 december 2005. (Data from the Swedish MPA.)"
