Big Pharma trying to stop long-term safety studies of ADHD drugs (Ritalin, Concerta)

A confidential document, now made public by a Swedish court, tells how pharmaceutical companies (calling themselves the “Consortium”) are trying to stop long-term safety studies of ADHD drugs (Ritalin, Concerta)

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 “Consortium”).”

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 trick”. This means that any and all adverse reactions from the drugs are explained away as signs of a “co-occuring disease”. 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.”

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 ).

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.”

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://www.transworldnews.com/NewsStory.aspx?StoryID=244733