Roaccutane / Accutane: Jicks Study

Introduction:

At the FDA public meeting on psychiatric side effects of Accutane/Roaccutane held on 19 September 2000, Roche made extensive use of what they called the Jick study in an effort by Roche to refute the endless number of independent public studies showing link between ingestion of Accutane/Roaccutane and the emergence of depression/psychosis and suicide/suicide ideation.

The Study:

The Jick study was commissioned and financed by Roche. The co-author of the study with Dr. Susan Jicks was a Roche employee, Dr. Kremers, F. Hoffman-La Roche Ltd, Basel, Switzerland. The study concluded that there was no evidence that isotretinoin (Accutane/Roaccutane) use is associated with an increased risk for depression, suicide or other psychiatric disorders Click here for copy of Jick Study.

Roche have used the study to promote the safe use of Accutane/Roaccutane and minimise the psychiatric adverse reactions of Accutane/Roaccutane in the media, to dermatologists and in court cases.

Criticism of the Jick Study:

**At the September 2000, FDA meeting, senior executives of the FDA were heavily critical of the Jick study (see FDA section of this website). Three senior executives of the FDA issued public letter to the journal that published the Jick study setting out criticisms of the Jick study. The following is copy of the letter issued by the FDA three executives published in the August 2001 issue of the Archives of Dermatology. Click here to download FDA response to publication of Jick Study. The authors stated that -"The industry-sponsored study conducted by Jick et al was intended to help resolve the question of etiology of depression in patients treated with isotretinoin. However, because of the limitations of the study, we believe that the findings are inconclusive and that further studies on the association between isotretinoin and depression should be initiated".

***Ng, 2001 (Case Report) -"Despite having the largest data set yet published, the study remains inconclusive because of methodological limitations including the retrospective study design, use of computerised database, inadequate method for case recognition and lack of psychometric measure. Significant variables like severity of acne, treatment compliance, concomitant medications and comorbid conditions were not adequately controlled."

***Bremner, 2003 (Review) -"There are several limitations to this study that are worthy of comment." Psychiatric diagnoses were recorded in the database only when patients were hospitalized or were evaluated by a psychiatrist for depression."."The authors also reported relative risks as high as 1.8 for depression with isotretinoin (that is close to a 2-fold increase in risk), which would probably have been statistically significant with a larger sample."

***Hull, 2003 (Review)- "[T]here are a number of weaknesses in the study design" "Much of the study was not about depression. Other weaknesses include the failure of the drug data to maximize the identification of the study disease and lack of an attempt at validation".

Submissions to Dr. Susan Jick, main author of the Jick study:

Mr. Liam Grant, Chairman of the Accutane/Roaccutane Action Group, made submission to Dr. Jick, dated 15th August 2001, setting out a number of detailed questions on the accuracy/inaccuracy of data and information featured in the Jick study.

Click here to download copy of submission by Mr. Liam Grant to Dr. S. Jick dated 15 August 2001.

Dr. Jick initially responded by stating the area of epidemiolology is a very complicated field and that the questions raised had complicated answers. That instead of issuing written response, she would meet with Mr. Grant if Mr. Grant travelled to her offices in Boston, USA. Mr. Grant agreed to travel to Boston, USA to meet Dr. Jick in mid-September 2001. When dates for the meeting were being finalised, Dr. Jick issued email to Mr. Grant stating that she would not agreed to meet with him and also would not agree to provide a response to the submission dated 15 August 2001.

The Accutane/Roaccutane group believe it is essential that Dr. Jick and her co-authors be forced to issue a full and detailed response to the submission dated 15 August 2001. We have called upon the FDA, the US Congress and other organisations to help us in securing a response.