Confidential report reveals: Big Pharma trying to stop long-term safety studies

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Confidential report reveals: Big Pharma trying to stop long-term safety

studies of ADHD drugs (Ritalin, Concerta)

_http://www.transworldnews.com/NewsStory.aspx?id=244733 & cat=10_

(http://www.transworldnews.com/NewsStory.aspx?id=244733 & cat=10)

 

 

A confidential document, now made public by a Swedish court, tells how

pharmaceutical companies (calling themselves the “Consortiumâ€) are trying

to

stop long-term safety studies of ADHD drugs (Ritalin, Concerta)

 

Stockholm, Sweden 3/04/2010 10:13 PM GMT (TransWorldNews)

 

 

The companies producing methylphenidate products (like Ritalin and

Concerta) are normally competitors, marketing ADHD as a disease and the

narcotic

drugs as its solution. But when they are threatened with marketing

restrictions they have a common interest.

 

 

If more scientific long-term studies would be done showing the harmful

effects of the drugs it could lead to withdrawal from the market of this class

of drugs. Therefore Big Pharma has to stop all such studies not written

and controlled by themselves. The only studies they support are those

conducted by paid researchers like psychiatry professors Joseph Biederman,

Timothy

Wilens and Thomas Spencer, where the outcome is known already from the

beginning.

 

 

The European Commission has 27 May 2009, after a long review by the

European Medicines Agency (EMEA), decided to issue warnings about

methylphenidate

drugs. The Commission has also decided that a number of long-term studies

of good quality should be done to investigate different harmful effects of

these drugs.

 

 

So for example the manufacturers were ordered to submit data how they

could do long-term studies of psychiatric adverse effects (e.g. depression,

hostility and psychotic reactions) and of cognitive effects (effects on

learning, intellectual function) of the drugs. The answer from the

pharmaceutical

companies was a confidential report Feasibility Assessment of a Study of

Long-term Effects of Methylphenidate on Cognition and Psychiatric Outcomes

written 30 October 2009 – now made public by a Swedish court.

 

 

As stated by the manufacturers: “This information is provided on behalf of

the following Marketing Authorisation Holders for

methylphenidate-containing medicinal products in the EU: Novartis, Johnson &

Johnson, Shire, Medice

and Laboratorios Rubió (also referred to as the “Consortiumâ€).â€

 

 

The document can only be characterised as an aggressive effort to explain

why long-term studies about adverse psychiatric outcomes of methylphenidate

treatment could not and should not be done, together with distorted facts

about the beneficial long-term outcomes of drug treatment. The intention

with the feasibility assessment study is clearly to stop or delay needed

safety actions for methylphenidate drugs.

 

 

The main method used by the Consortium to prevent the safety studies is

the “comorbidity trickâ€. This means that any and all adverse reactions from

the drugs are explained away as signs of a “co-occuring diseaseâ€. As the

Consortium says: “It is well established that ADHD co-occurs with other

psychiatric disorders.†The list that follows is long: “disruptive

behavioral

disorders such as oppositional defiant disorder, conduct disorder; and mood

disorders such as depression, bipolar disorder; and anxiety disorders.â€

 

 

Many references are made to Dr. Joseph Biederman – the father of the

disastrous invention pediatric bipolar disorder, and subject to Congressional

investigations in the US – and his colleagues, Wilens, Spencer and Faraone.

So for example we get to know that it has been found that 26% (!!) of the

children with ADHD also can have bipolar disorder.

 

 

With this the Consortium wants to say that when a child on methylphenidate

exhibits agitation or mania it should directly be seen as the “co-occuring

disease†bipolar disorder popping up. Meaning in turn that they now have

something more for which psychiatric drugs needs to be prescribed. This time

heavy antipsychotic drugs, like Risperdal, Invega, Clozaril, Seroquel and

Zyprexa.

 

 

The CAUSAL role for methylphenidate products in inducing psychotic

reactions, mania, aggression and hostility has been proven in many studies. The

long 2006 report from FDA about this subject, told very much (FDA,

Psychiatric Adverse Events Associated with Drug Treatment of ADHD: Review of

Postmarketing Safety Data, 3 March 2006,

_http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4210b_11_01_AdverseEvents.\

pdf_

(http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4210b_11_01_AdverseEvents.\

pdf) ).

 

 

It has taken many years to get the warnings out about these harmful

effects. Many children have been considered psychotic and put on antipsychotic

drugs – with even more harm produced – when the actual fact was that they

experienced toxic effects from methylphenidate drugs. Many children have

experienced new or exacerbated aggressiveness as a result of taking stimulant

drugs, which in turn have put them and people around them in danger.

 

 

But the pharmaceutical companies do not even accept these since long

proven harmful effects. In the conclusions section of the report they say: “

[data] do not indicate any signal of worsening of psychiatric symptoms or

cognition during treatment with MPH [methylphenidate] and even suggest a

beneficial long-term effect of MPH on the course of psychiatric disorders and

cognitive function over time.â€

 

 

So now it’s up to the European authorities to choose: Should they accept

the aggressive effort by Big Pharma to prevent the safety studies or should

they prevent continued harm on children?

 

 

See the now released report from the Consortium: Feasibility Assessment of

a Study of Long-term Effects of Methylphenidate on Cognition and

Psychiatric Outcomes _http://jannel.se/Consortium_ADHD-drugs.pdf_

(http://jannel.se/Consortium_ADHD-drugs.pdf)

 

 

 

 

 

 

 

Janne Larsson

Reporter – investigating psychiatry

Sweden