January 6, 2005
By: Janne Larsson
writer - investigating psychiatry
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. 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". 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 2-4 percent of all adults in the country are suffering from a "clinical severe form" of ADHD. 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.
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.
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. 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 Lilly Strattera Advisory Board - marketed the new pill in an excellent way on national TV in the end of 2004. 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." 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 so 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 impossible 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!
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.
For sure this must be considered a catastrophe?
The result, that 10 persons (half of the 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 had to be taken out due to harmful effects - and that it at last only remained one (1) patient 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."
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?
The legitimate claim must now be that the MPA is intervening to close down this failed experiment and to make sure that all details about the catastrophic results are being 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.
writer - investigating psychiatry
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