Eli Lilly's and Christopher Gillberg's failed experiment with Strattera

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Sat, 14 Jan 2006 00:23:32 -0000

[sSRI-Research] Eli Lilly's and Christopher Gillberg's failed

experiment with Strattera

 

 

 

 

 

Note: data for this report were obtained through the FOI act

 

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http://www.24-7pressrelease.com/view_press_release.php?rID=122

 

Eli Lilly's and Christopher Gillberg's failed experiment with

Strattera

 

The Swedish Medical Products Agency (MPA) knows that Gillberg's and

Lilly's clinical trial of Strattera is a catastrophe. It has

nevertheless been allowed to continue.

 

 

/24-7PressRelease/ - SWEDEN, January 04, 2006 - 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 and 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.

 

Janne Larsson writer from Sweden, investigating psychiatry

 

 

 

 

 

 

 

 

 

 

 

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