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Memorandum of Meeting Between the Roaccutane/Accutane Action Group and the Medical Control Agency (UK)
A meeting was on the, 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.
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 ha0-14
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