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Introduction


Accutane/Roaccutane Action Group was established arising from a public meeting attended by individuals and families of individuals, who have suffered, and in many cases continue to suffer, serious side-effects, including psychiatric disorderds attributed and linked to the taking of the acne prescription medication Accutane/Roaccutane.

Accutane/Roaccutane is prescribed in the treatment of mild, moderate and severe acne, mainly to young people in the age group 13 to 23. It may well be the only prescription medication on sale by pharmacists that has attracted label warnings featuring suicide, suicide attempt and suicide ideation as possible side-effects.

The main objective of the Group is to demand the appointment of an independent national and co-ordinated international investigation into Accutane/Roaccutane and the manufacturers of the drug, with free access to all Roche internal documents to study all aspects of safety data surrounding Accutane, with particular emphasis on (a) if studies could have shown the depression risk (b) if such studies had been suppressed by marketing and public relation worries and (c) if discussion of depression was suppressed in an uethical fashion.

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Committee

The Committee of R.A.G. was appointed at the Group's first formal public meeting held on January 23rd 1999.

A confidentiality agreement was entered into by the Committee in order to safeguard and protect the identity of members. The agreement provides that confidential information disclosed by members to the Committee, or to individuals on the Committee, shall be treated in the strictest confidence and shall not be disclosed to third parties without the express written consent of the person disclosing the information.

We have overr 2000 members who have suffered severe physical and psychiatric side effects. We are also working with similar groups in the US, Australia, Canada, United Kingdom, France, Norway, Sweden, Italy and South Africa.

We are anxious to make contact with people in every country where the medicaiton is sold who may be willing to provide assistance or who are willing to join as members.


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Objectives

In our view:

  • Accutane should only be used for severe recalcitrant cystic acne as a treatment of last resort, in accordance with the license. We believe that more than 80% of patients prescribed Accutane have mild or moderate acne, which is in violation of the license. A study published by Cunliffe (Leeds University Hospital) involving survey of several hundred dermatologists showed that 74% of patients were prescribed Accutane for mild or moderate acne. Prescribing Doctors should be required to certify that patient's acne is within the license guidelines

  • The immediate provision of medical advice and assistance should be organised by national health authorities and made available to people who have suffered adverse reactions. Appropriate medical treatments must be devised to counteract the serious side effects linked to the medication.

  • Patients should be psychiatrically assessed before and during Roaccutane treatment (possibly by using the Hamilton scale of depression questionnaire) and in the event of an adverse reaction, the patient should be immediately taken off the treatment and the adverse event should be reported to the national health authority.

  • Sale of Accutane on the Internet should be immediately prohibited. Patient should have all the appropriate tests (blood tests, pregnancy tests) prior to and during treatment and this needs to be strictly enforced.

  • Independent studies need to be carried out to establish exactly how Roccutane functions in the human body and to determine the chemically induced changes that occur in the brain and other parts of the body arising from the ingestion of the drug. Until such information is available we believe that the license for Roaccutane should be withdrawn.

  • Independent investigation of Roche (manufacturers) and their ADR database. The investigation should also assess whether Roche made adequate disclosure to national drug monitoring agencies, prescribing doctors, the public, patients and the families of patients regarding ADRs.

  • To make known the extent to which Roche failed to make adequate disclosure of information on side-effects, scientific literature reports, adverse drug reaction reports to National Health Authorities and Dermatologists.

  • To establish why Roche failed to commission scientific studies on the physical and psychiatric effects of Roaccutane.

  • To investigate whether or to what extent Roche failed to disclose serious side effects revealed at pre trial studies conducted by Roche as part of process for obtaining licence for sale of Accutane / Roaccutane.
  • To investigate all Roche adverse reaction data bases in order to determine whether individual case reports have been passed on by Roche to national agencies and whether comparison of data recorded by Roche in respect of individual patients is consistant with the actual report prepared by doctors and submitted to Roche in respect of individual patients.

  • To secure the appointment of an independent international committee to investigate all aspects of the medication from it's original development, pre trial studies, adverse reaction data bases, scientific literature reports,failure by Roche to carry out any investigations whatsoever with a view to determining the mechanism by which the medication caused so many serious side effects, investigation of senior Roche executives and persons in the pay of Roche who promoted increased use of the medication without reference to serious and known side effects . That such a committee should include independent medical specialists, medical statisticians, experienced investigators, and with legal powers that provide the committee with access to Roche local and global ADR data bases.


Achievements

Contacts have been established with a number of national and international agencies, to collect all available data on reported adverse reactions in respect of Roaccutane.

Submissions have been made to governments and national / international health agencies, including the FDA, to highlight serious side effects and to demand proper independent studies, which Roche have failed to carry out.

Representations have been made to a number of politicians to have questions raised in parliament and at E.U. level, with a view to obtaining political support in pursuit of achieving the objectives of the Group.

We have commissioned a number of research studies to investigate the link between Roaccutane and depression and to investigate the mechanism by which the drug causes so many serious physical and psychiatric side effects.

We have pursued the establishment of an International Action Group in order to consolidate efforts to provide a unified plan of action to highlight the severe suffering caused by Roaccutane and to forca the appointment of an independent international investigation on Accutane/Roaccutane.

The Committee would appreciate the expertise, assistance, contacts, ideas an help of any kind, from people who support the Group's objectives.

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