Memorandum of Meeting between the Roaccutane/Accutane Action Group and the Medical
Control Agency (UK)
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
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 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
-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.