Open Medicine EU

Pharma Company goes to Court in France

Posted by jim on 18/01/11

The UK is not the only country where opinions on medicines can be challenged in court.

In France, Astellas Pharma, a Japanese multinational pharmaceutical company has filed a lawsuit in Paris against the independent French medical journal, Prescrire, for publishing unfavorable comments about their anti-eczema ointment, tacrolimus (brand name – Protopic).

The case arises from an article in the September 2009 edition of Prescrire. You can read the original in French here and an English version here, translated by me (with some help). Only the French verson is valid.

I am publishing this without the knowledge or approval of Prescrire.

This is a blog about science, transparency and medicine and I thought it to be in the public interest to show readers the article, so that they can better understand the issues in the case and, eventually, the judgement of the court.

Remember that Astellas strongly reject the claims in the article and assert that it was wrong for Prescrire to publish it. The court now has to decide the issue in accordance with French law and the detailed facts (of which we know little) of this specific case.

A decision is due on 16th February. I will report the outcome of the cae when it is in the public domain.

Remember also that the European Medicines Agency and the FDA have approved, subject to specified conditions (including a Black Box warning in the US), the use of tacrolimus for short term and maintenance treatment in certain cases.

The Prescrire article was in effect a response to, and disagreement with, the EMA’s decision to authorise the medicine, especially for long term use.

Readers may wish to post information about this medicine, but please keep it scientific. I have great sympathy with anyone who has suffered adverse effects from any medicine but this blog is about science, transparency and medicine.

J’accepterai aussi des commentaires en français, mais brièvement s’il vous plait, a fin que je puisse les traduire en anglais!!!

BioTech, English, EU Priorities, Health & Lifestyle, Public Affairs, Science & Research, Social Europe, Uncategorized
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4 Responses to Pharma Company goes to Court in France »»

Ilaria Passarani – BEUC

Comment by Ilaria Passarani – BEUC | 2011/01/31 at 11:34:28

Jim,
In the context of the initiative “ Questa la racconto” ( I tell you my story) , Altroconsumo collected consumers’ experiences of adverse reactions following the use of two creams to treat eczema, namely Protopic and Elidel. Regarding Protopic, from June 2006 till January 2009 they received 282 feedback reports.This exercise showed that the two creams were sometimes prescribed for ages not authorised, as first option and not as second option treatment as required by the competent authorities and for longer periods of time than suggested. The results were extensively discussed and elaborated with the Italian Medicines Agency (AIFA) and presented to the European Medicines Agency on 5 March 2009. Below a short letter BEUC and Altroconsumo sent to the EMA on 5 May 2009:

Dear ..,

Following the presentation by Altroconsumo at the patient and consumers working party (PCWP) meeting on 5 March 2009, we would like to ask you to issue a Direct Healthcare Professional Communication (DHPC), commonly called “Dear Doctor-Letter” to recommend health care professionals a greater caution in the prescription and distribution of the dermatological medicines Protopic and Elidel in order to reduce potential risk of skin cancer and lymphoma as far as possible and to better ensure a rational use of these medicines. We consider important to remind health care professionals that:

- they should use these drugs only in patients with atopic dermatitis who are intolerant of or failed to respond adequately to conventional therapies (topical corticosteroids);
- that to prescribe them they should be expert in the diagnosis and treatment of atopic dermatitis;
- these drugs are not recommended for use in children below the age of 2 years;
- these drugs should be applied as a thin layer;
- treatment should be intermittent and not continuous.

Looking forward to hearing from you.

Yours sincerely,
…
jim

Comment by jim | 2011/01/31 at 13:11:43

As a result of earlier efforts of Altro Consumo or not, Astellas did circulate a Dear Doctor letter when Protopic was first marketed for maintenance treatment.

You will find here a copy of the letter sent to Irish health care providers dated February 2010.

The letter states that it was approved by the CHMP – it was also required by the CHMP (Committee for Medicines for Human Use of the European Medicines Agency).
Chrisinet

Comment by Chrisinet | 2011/02/06 at 22:54:33

Prescrire has the reputation for being the only (and last) french practicitionner magazine completely independant from the pharamaceutical industry.Which is very courageous these days…
jim

Comment by jim | 2011/02/07 at 00:06:43

Yes, they are good. I’m an admirer.

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Pharma Company goes to Court in France

4 Responses to Pharma Company goes to Court in France »»