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

[Guest guest]

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

=================\

http://www.24-7pressrelease.com/view_press_release.php?rID=10122

Eli Lilly's and 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 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

[Guest guest]

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

=================\

http://www.24-7pressrelease.com/view_press_release.php?rID=10122

Eli Lilly's and 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 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