Acne drug 'should be banned'
May 2002
http://news.bbc.co.uk/hi/english/health/newsid_1991000/1991058.stm
An acne drug which has been linked to teenagers' deaths should be banned in
the UK, campaigners will tell health officials on Friday.
Families will tell the Medicines Control Agency (MCA) they believe the drug
Roaccutane caused mental and physical harm to their children and ask for its
UK licence to be withdrawn, pending further research.
MCA statistics show 15 young people have committed suicide in Britain while
taking the drug.
But pharmaceutical company Roche which makes the drug rejects the suggestion
that the drug is in any way to blame for the suicides or depression and
insist the drug is safe.
Liam Grant, one of the campaigners meeting the MCA, wants Roche to be forced
to carry out more studies to find out what effect their product is having on
teenagers.
He is one of those calling for the drug's UK licence to be withdrawn, but he
said if that did not happen, it should at least be made subject to stricter
controls.
Mr Grant said: "In the United States you have to sign a ten page form which
shows that the doctors has described the side effects that you understand
them and it also has a book that showing how you can identify depression and
so on.
"In the UK there's a one page warning which has the smallest possible print
and no explanation as to what is depression how do you identify it and so on
.. so there's a whole load of issues we have to talk about with the MCA."
Joan Gauge from Cornwall said her son Kevin became severely depressed when
he was prescribed Roaccutane.
She told the BBC: "He went from being sociable, lively, totally full of life
to being morose depressed just suicidal.
"Every day he cried, he wept, he had tremendous mood swings. The worst thing
was for us there was no end in sight."
Kevin started taking the drug in the early 90s. He said he was not warned
the side effects could be so severe.
He said: "I'm 110% convinced that if I hadn't gone on that drug I would not
have experienced what I did do.
"It got horrendous. The knife was literally by my wrists.
"I was at such a low stage and could see no way out of it whatsoever. I was
thinking really seriously about taking my own life."
In the US, the family of teenager Charles Bishop, who crashed his light
aircraft into the side of a building in Tampa, Florida in January this year,
blame Roaccutane for his death.
The US has seen public congressional hearings on the controversy surrounding
the drug.
Although Roche denies Roaccutane is to blame for any deaths or serious
mental problems, since 1998 the company has been obliged to include a
warning on the packaging that "it may cause depression, psychotic symptoms
and rarely suicide attempts".
Experts recognise that teenagers with severe acne are prone to depression
and suicide.
Dr Trisha Campbell, UK head of medical affairs for Roche, told the BBC
around 12m people had taken the drug over the last 20 years.
She said: "Clearly, my heart goes out to any parent of a child who is
suffering from depression or who has taken their life.
"I can understand that they will want to leave no stone unturned to find the
cause for it."
She said the drug was "fantastically effective" in treating acne.
Dr Campbell added that there was absolutely no link between the drug had
been linked to depression or suicidal tendencies.
She added: "There is no evidence that Roaccutane is actually responsible for
these cases.
"There could be umpteen reasons why these cases have occurred."
She said the research the families were calling for was impossible because
the cases they cited were very rare.
Dr Campbell added any controlled study of the drug would involve giving
people a dummy version of the drug - which would be self-evident because
their acne would not clear.
Dr Tony Chu, a dermatologist at the Hammersmith Hospital in London said the
drug is the most effective treatment for people with severe acne.
But he said: "I do think it's overused .. I do think too many patients are
given it.
"If you've got a patient who is demanding something in your surgery it's
often easier and quicker to say oh fine we'll do a blood test these are the
warnings and we'll give it to you because it takes less time doing that than
actually arguing with them and saying no you can't have it because x y and
z."