Pre-trial Studies

Professor Cunliffe was involed in pre-trial studies on Accutane/Roaccutane in the late 1970's in the UK. Professor Cunliffe has written several articles and books on acne and the use of Accutane/Roaccutane.

Cunliffe Position on the Management of Pregancies while on Roaccutane

In 1989, Professor Cunliffe wrote in a book entiled 'Acnes', published in 1989 that "obviously the main systemic side-effect of Isotretinoin is the risk of teratogenecity. Some centres advise the use of a pre-pregnancy test. This author's department does not practice this but puts the fear of God into the female: she is asked to sign a consent form indicating that she is not and must not become pregnant when on the drug and for a month afterwards. Furthermore, she is persuaded to sign that, should pregnancy occur, then she would agree to an abortion".

Professor Cunliffe's incorrect statements regarding patients he treated who developed depression and committed suicide while on Roaccutane treatment

Professor Cunfliffe was hailed as an 'international expert' on the use of Accutane and when questioned as to whether he had any patients who had committed suicide while on Accutane/Roaccutane therapy he responded "what I can state categorically is that no patient [who had committed/attempted suicide] was on or had just had, or had previously received oral isotretinoin (Accutane/Roaccutane)" (Source letter issued to Mr Grant dated 16 March 1998).

it was later established that in fact two of his patients who were receiving Roaccutane/Accutane committed suicide (Source: Brirish Journal of Dermatology 1997; 137;246-250)

Professor Cunliffe's incorrect statements regarding the number of suicides associated with the ingestion of Accutane/Roaccutane reported to Roche

Professor Cunliffe stated that there six cases of suicide on the Roche database on the 14th January 1998. He further stated that "the six cases of suicide reported to Roche does not include any of my cases, because none of my patients were on Roaccutane". Mr Grant had obtained copy of suicides reported to Roche dated December 1997 - there were 26 cases listed. It has never been fully established why Professor Cunliffe provided false information or why Professor Cunliffe did not report cases of suicide which occured while on Roaccutane therapy to Roche or National Medical Agencies.

Publications by Professor Cunliffe

Professor Cunliffe has published over 60 papers relating to the use of Roaccutane. He worked in conjuction with Roche in pre-trial studies in the early 1980's and has continued to publish scientific papers to diminish toxic side effects of the drug and to promote the use of the drug in patients with mild and moderate acne, despite the license condition that the drug should be used for severe acne only. Professor Cunliffe has also issued statements to the media regarding the safety of Roaccutane and has issued letters and leaflets to doctors advocating the use of Roaccutane.

The following are some examples of studies which were published by Professor Cunliffe, Leeds General Infirmary, UK and the Leeds Foundation for Dermatological Research :

2000:'A Clinical and Therapeutic Study of 29 Patients with Infantile Acne'. Br J Dermatol. Professor Cunliffe recommends that use of oral Isotretinoin may be necessary in a small number of infantile patients unresponsive to conventional long term oral antibiotic therapy.

1998: Cunliffe issued an information statement produced on behalf of the British Association of Dermatologists (BAD) in their newsletter in response to increased label warnings for Roaccutane featuring suicide introduced in the UK. The leaftet stated that a presentation by Dr Gawkrodger at the British Association of Dermatologists (BAD) Meeting "showed that proir to Roaccutane 16% of patients had clinical depression which disappeared at the end of a course of Roaccutane".

This was later corrected and Professor Cunliffe has admitted that he misquoted Dr Gawkrodger, which was subsequently published in 1999 in the British Journal of Dermatology. In fact the data showed that, prior to treatment, 18% were significantly depressed (self reports). Treatment with isotretinoin did not alter the emotional status of patients which were found to be resistant to change.

1997:'Sucide in dermatoligical patients'. Br J Dermatol. The paper concludes that 'This paper underlines the importance of skin/mind relationships and the importance of recognizing mental disease and particularly depression in our patients. It also serves to emphasize the need for the early use of isotretinoin both to control inflammatory acne and lessen subsequent acne scarring.'

The paper outlines 16 patients who committed suicide after presenting wtih dermatological problems to two dermatologists. They fail to address the two patients who were treated with isotretinoin who subsequently committed suicide and failed to refer to depression which was labeled as a potential adverse side effect of Roaccutane.

1997: 'Roaccutane treatment guidelines: results of an international survey.' Dermatology. The study concludes: Our recommendation is that oral isotretinoin should be prescribed not only to patients with severe disease but also to patients with less severe acne, especially if there is scarring and significant psychological stress associated with their disease. Acne patients should, where appropriate, be prescribed isotretinoin sooner rather than later

1995: 'Current indications for isotretinoin as a treatment for acne vulgaris.' Dermatology. The study states: This article states, “Initially it’s (Roaccutane/Isotretinoin) principle use was in the treatment of severe Nodular Cystic Acne, but in recent years Dermatologists have increasingly prescribed Isotretinoin to treat patients with moderate or even mild acne, unresponsive to conventional antibiotic therapy. Between 1983 and 1986 severe acne was the main indication for Isotretinoin (79% of patients) in our unit (General Infirmary at Leeds, UK), with only 21% of treated patients graded as having moderate acne. This contrasts with our current figures of 74% of patients with mild or moderate acne and 16% only with severe acne”. and concludes that: "Patients who show only partial response to conventional antibiotic therapy should be prescribed isotretinoin in order to minimize scarring and significant psychological disturbance, independently of the severity of the acne".

1994: 'Long-term safety of isotretinoin as a treatment for acne vulgaris'. Br J Dermatol. The study was conducted in response to the media coverage of 21 Norwegian patients who experienced CNS symptoms which were reported to have started two or more years after treatment. The study concludes: The findings of this study indicate that isotretinoin in the treatment of acne is a safe drug, with no serious long-term side-effects.

Criticism of the study by Dr. Alan Byrne in his publication entitled 'Isotretinoin therapy and depression - evidence of an association'. Dr. Byrne states that Cunliffe paper clearly signalled very clearly their belief that the incidence of depression is very low in those treated with isotretinoin, but their findings are open to alternative interpretation, as persistent lethargy was noted in tow of their patients and these patients were lost to follow-up. Obviously these individuals might well have developed depression, but the outcome in their cases was not determined. Dr Byrne also states that three other patients in the Cunliffe study were noted to experience depressive symptoms but the authors repeatedly suggest that the presence of dysmorphophobia in these individuals in some way minimises the depression diagnosis and they concluded that it is not a long-term side-effect of isotretinoin therapy. An incidence of 0.5%-1% of a sample developing depression, with or without dysmorphophobia, must be seen as significant at a clinical level.

1993: 'Isotretinoin for acne vulgaris--10 years later: a safe and successful treatment'. Br J Dermatol. The study concludes: We did not elicit any long-term systemic or biochemical side-effects. We conclude that isotretinoin is a safe and effective therapy.

1992: 'Guidelines for optimal use of isotretinoin in acne'. J Am Acad Dermatol. The study concludes: Isotretinoin is a consideration in such patients to reduce the physical and psychological effects of acne, particularly because there is no simple method to treat acne scars.

Submission to the Leeds University Hospital.

A report was submitted to the Leeds University Hospital to seek a formal inquiry on all studies, including pre trial studies, conducted by Professors Cunliffe and Leeds Hospital/Leeds University for and on behalf of Roche in connection with the drug accutane/roaccutane covering the period from 1978 to the present date. Click here for full submission.

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