New Moves To Alert UK to Dangers of Suicide-Linked Acne Drug
Pressure is growing on medical authorities in Britain to take action over the use of the acne drug Roaccutane/Accutane following its link to side effects including depression, psychosis, attempted and real suicide.
(PRWEB) November 29, 2001
A new Roaccutane/Accutane Action group will be formed by victims of the drug and their relatives at the Novotel, Hammersmith at 2.00 pm on Saturday December 1 with the aim of raising awareness over the use of the drug among the public and medical world, bring pressure for a change in its labelling and to help organise legal action in cases where it has been specifically linked to attempted and actual suicides.
MPs have received detailed information in order to have questions raised at Westminster and already a leading member of the Scottish Parliament has promised to take action.
The drug, manufactured by Roche is marketed as Roaccutane in Europe and Accutane in the US.
So far the lack of action in the UK contrasts markedly with extreme concern demonstrated in the United States where Congress is about to hold a second public hearing into the psychiatric side effects of the drug in January ( the first US Congressional hearing was held on 6th December 2000). The U. S. licensing authority, the Federal Drugs Administration have also held separate public meetings on psychiatric side effects and are engaged in a full scale investigation.
In the UK the Medical Control Agency (MCA) released figures in February 2001 stating that since the introduction of the drug in 1982, 1,795 adverse reactions have been recorded on their database, of which 23 were fatal, 14 being actual suicides. More than 200 of the adverse reactions were psychiatric with 20 reports of suicidal thoughts or suicide attempts. There were 80 reports of depression and 13 reports of mood swings. In the US there are believed to have been in excess of 500 suicides, attempted suicides and suicide ideation recorded for the drug.
The meeting will also give sufferers here an update on legal proceedings in both the US and the UK where a new team of lawyers are about to be appointed to investigate the background to the drug ahead of proceedings. £10,000 of legal aid was granted some years ago but this was not enough to carry out the painstaking research necessary to bring actions. Now the 100+ UK legal cases will be able to borrow on much of the costly “ legal discovery” work already well down the track in the US.
The group is not calling for Roaccutane to necessarily be banned but for there to be much stricter controls on its use. It is licensed in the UK for use as a drug that should only be used for severe cystic acne, a treatment of “last resort” but some 74% of UK patients prescribed Roaccutane had mild or moderate acne according to a study among UK dermatologists.
The meeting will also explain just what is happening in the UK and in other
Countries with research into the psychiatric side effects. There are over 40 independent studies published in medical journals linking the ingestion of the drug to the emergence of depression, psychosis and suicidal thoughts/actions.
If you would like to attend the meeting or gather more background on Roaccutane/Accutane please contact David Wallen/John Cox at LIVEpr on 020 7630 1100 and we can put you directly in touch with those who have suffered, along with lawyers and others involved. More extensive details can also be found on www. roaccutaneaction. com.
Objectives of the Group
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 (for example 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. Roche have continuously failed to carry out such studies. We believe that the license for Roaccutane should be withdrawn until such studies are carried out..
· 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 Adverse drug reactions (ADRs).
· To establish by public enquiry 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 psychiatric effects of Roaccutane.
· To investigate the extent to which 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 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 consistent 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, predictable 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.
