A meeting was held today, 17th May 2002 at 10:30am between the Medical Control Agency (MCA) in the UK and Mr. Grant, Dr. Chow and Mr. David Chow (Members of the Roaccutane/Accutane Action and Support Group).

Four representatives (including Dr. J. Raine, Director Post licensing Division) of the MCA were present and the meeting lasted almost three hours.

A wide range of issues were covered.

1. Adverse Drug Reaction Reports on the MCA database.
The number of UK adverse reaction reports submitted to the UK for Roaccutane include 15 cases of suicide, 10 cases of suicide attempt and 13 cases of suicide ideation totaling 38 cases. The number of people prescribed Roaccutane in the UK since 1983 is less that 50,000.

Reference made to Roche disclosures up to June 1997 that there were up to circa 4 million people prescribed the drug but when suicide warning was introduced that number increased overnight to 16 million. How we challenged Roche who then reduced number of people prescribed. How Roche contine to manipulate such numbers and how we demand that the MCA establish the number of people prescribed the drug in the UK and other countries from 1982 to date and that such roche numbers be independently verified with roche distributors and with previous disclosures by roche. Referred also to 50,000 people prescribed in UK and how that number was calculated including reply in House of Commons in 1997.

It was agreed that the number of cases of suicide reports in relation to the number of people was unprecedented compared to other prescription medications. The MCA Caveat docuement on ADR's state that only 1 in every 10 ADR's are reported and it was agreed therefore that the 38 cases were only the tip of the iceberg.

2. Studies
We discussed Roche financed studies, which were unique in that they made little or no reference to serious physical or psychiatric side effects and promoted increased use of the drug. We then referred to over 41 independent studies by pharmacologists, pharmacists, psychiatrists, dermatologists, doctors and general scientists linking the ingestion of the drug with psychosis, depression, emotional lability, schizophrenia and suicide.

3. Urgent Studies Required
We insisted that Roche be forced to finance a study where patients prescribed Roaccutane would be monitored using the Hamilton Scale of Depression which is one of the most reliable scales for monitoring depression and also be monitored using brain scans before during and after treatment, as recommended by medical professionals and psychiatrists.

Roche categorically refuse to carry out such studies and we asked the MCA to withdraw the license until such time that Roche agreed to provided the finance to have such studies completed.

4. Label Warnings
We discussed increasing the label warning from the 1-page UK warning to the 12-page US warning. The UK features depression and suicide in the label warning but doesn't explain what patients should be looking out for and how they can identity depression compared to the US label warnings which explains in detail what the signs of mental problems are. The US license also stipulates that patients must give written consent each month they collect their prescription at the pharmacy and each month when they attend the prescribing doctor. US patients are allocated a number which is recorded in a register. The UK label warning is completely inadequate compared to the US. The MCA said that they had been looking at increasing the warnings prior to the meeting and would keep us informed on proposals that are forthcoming.

5. Roaccutane Prescriptions outside the License

We discussed the extent to which the drug is prescribed outside the license. The MCA had already been aware of this and stated that prior to the meeting.

They accepted UK doctors are extensively prescribing the drug outside the license conditions. They also stated that they were investigating what actions to take to stop doctors and dermatologists who prescribe the drug outside license conditions.

6. Leeds Hospital/University

We referred to our submissions to Leeds Hospital/Leeds Foundation and correspondence with Leeds featured on our website (www.roaccutaneaction.com). We referred to over 60 published studies by Professor Cunliffe/Leeds Hospital and members of medical team at Dermatology Dept of Leeds Hospital. How these studies made no reference to serious adverse reactions featured in physician and label warnings. We referred to investigations on millions paid to Leeds by Roche and monies paid by Roche to Cunliffe and others associated with the Roche financed studies. We requested that all these matters be investigated and that MCA should seek copy of pre-trial studies conducted by Cunliffe/Leeds for Roche. We referred to number of people who suffered severe side effects treated at Leeds and asked that all these matters be investigated by the MCA.

7. Roche Frauds

We referred to Roche multi billion dollar frauds including 10 billion dollar settlement by Roche with suppliers defrauded which attracted fines of $500 million by FBI and fine of $420 million by EU Interpol in 1997.

-A separate Roche fraud reported last year which gave rise to fines of $520 million
-Various other Roche Frauds which put Roche as the leading corporate fraudsters worldwide. We questioned how a company who was so heavily involved in fraud could be trusted to sell prescription medicines.

8. Leaflet distributed by Dermatologists following suicide warnings applied by MCA

The MCA were provided with a leaflet distributed by UK and Irish dermatologists (in the months following the suicide label warnings) to patients who expressed concerns about the drug causing depression or psychosis. The leaflet featured Roche proganda (leaflet was signed by Professor Cunliffe of Leeds Hospital, Dr Tony Chu of Hammersmith Hospital and also featured Dr Gawkrodgers (Sheffield) a Roche sponsored dermatologist). The leaflet may have been sponsored and distributed by the British Academy of Dermatologists and was issued with the sole intention to dilute and neutralise the increased warnings applied by the (UK) MCA featuring depression, psychosis and suicide. We requested that all matters relating to this be investigated by the MCA including who financed the leaflet, the level of fees and payments made by Roche to the three doctors featured in the leaflet and level of financing paid by Roche to the British Academy of Dermatology.

9. Cunliffe/Leeds 2001 Study Recommending Roaccutane/Accutane for use by Infants aged 6 months to 16 months

Provided the MCA with a copy of study by Cunliffe and colleagues at Leeds Hospital published in the British Journal of Dermatology in September 2001 entitled ' A clinical and therapeutic study of 29 patients with Infantile Acne'' which recommended 'when necessary, oral isotretinoin [accutane] can be used'. This article, like over 60 other Roche sponsored Cunliffe/ Leeds published articles made no reference to serious physical and mental side effects listed on the label and physician warnings for the drug. The MCA was asked how Cunliffe/ Leeds can be allowed to feature such a disgraceful article recommending the drug for infants whose brain and central nervous system are at the early stage of development and where there is no mention that the drug has the more horrendous physical and psychiatric listed side effects including suicide, suicide attempt and suicide ideation. Reference was made to how such articles are being used by Roche to promote the drug as safe and where such articles are not obliged to list serious side effects. Request that the MCA have this and other Cunliffe/Leeds published articles formally withdrawn and that these parties be publicly be censured.

Reference made for need to investigate all aspects of Cunliffe including apparent facial imperfections and whether these in any way influenced Cunliffe’s role in the promotion of roaccutane without any reference to undisputed severe physical and psyciatric listed and side effects.

10. Government Enquiry

We asked them to support our call for a UK government enquiry. The MCA stated that it would take them some time to look at the evidence and documentation that they were presented with at the meeting. At this point they assured us that they would carry out their own investigation and would deal with each point made at the meeting.

They will issue the group with a report of their findings and recommendations as soon as the investigation is completed.