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Fight to prove acne drug caused
suicides
JOHN BURNS
A BUSINESSMAN whose son committed suicide while taking the acne treatment
Roaccutane has spent almost £500,000 on independent research to try to
prove that the drug causes depression.
Grant is using the research in his legal action against Roche Pharmaceuticals,
the drug's manufacturer, in the hope of forcing it to admit liability.
Grant is one of hundreds of people worldwide who believe that family members
killed themselves because of the side effects of Roaccutane, a "last resort"
drug for severe acne that can be prescribed only by consultant dermatologists.
His son, also called Liam, was a student aged 20 when he took his own
life in 1997. His father claims that he had become seriously depressed
after taking Roaccutane in the months before his death.
In the same year Seumas Todd, the 20-year-old son of Richard Todd, the
actor, also committed suicide after taking the drug. His father said Seumas
became depressed after taking Roaccutane and he believes that it was "undoubtedly"
a factor in his death. An inquest in October heard that Jon Medland, 22,
a medical student at Manchester University, hanged himself earlier this
year after being prescribed Roaccutane.
Leonard Gorodkin, the Manchester coroner, called for the drug to be investigated.
Grant has sold properties that were intended to be his pension fund to
finance his research. "I realised that the only way studies on Roaccutane
were ever going to be undertaken was if I personally commissioned and
financed them," he said.
"I engaged experienced scientists to identify what precise studies were
needed and I commissioned the most relevant. "I had to sell two properties
to finance the studies; money readily spent in the name of my wonderful
son Liam who I know with certainty would still be alive today if he had
not taken Roaccutane."
Grant hired J Douglas Bremner of Emory University hospital in Atlanta
to check what effect the anti-acne drug had on the brain. Bremner's preliminary
finding was that those who took Roaccutane showed decreased activity in
the orbitofrontal cortex, a brain area thought to control mood and social
interaction. Brain scans showed that acne patients who took antibiotics
instead showed no change.
Dr Peter McCaffery, from the University of Massachusetts Medical School,
was commissioned to study 13-cis retinoic acid, the active ingredient
of the drug, and found that it reduced cell proliferation in the brains
of mice and disrupted their capacity to learn spatial maze tasks. Grant
plans to use this to show that the drug has a detrimental effect on the
brain.
The court case being heard in Dublin seeks damages for the distress suffered
by Grant because of the loss of his son as well as demanding an admission
of liability. Grant has already turned down an ex gratia offer to drop
the case in return for compensation that would have cost Roche up to £800,000.
In an open letter to Grant and without admitting liability, Roche's lawyers
offered to settle the case "having regard to the enormous costs and resources
which would be involved in fighting the litigation and the length of time
that a trial would take".
The drug firm, which is based in Switzerland, was offering him a sum equivalent
to the amount he might have won in an Irish court, along with special
damages and costs.
However, Grant believes that Roche offered to settle to avoid handing
over its own research documents in court. A pre-trial deposition in a
lawsuit against Roche in Florida heard that one of the company's doctors
recommended that users of the drug be monitored for signs of depression.
A spokesman for Roche said that it had offered to settle the case in order
to avoid lengthy and distressing litigation.
It said that about 13m people have been treated with Roaccutane since
it became available more than 20 years ago. "It is a well tolerated and
effective medicine which means we have no option but to dispute the claim
Mr Grant made," the spokesman said. "We continue to have the fullest confidence
in the drug."
Roche disputes Grant's estimate of his costs and its lawyers are to make
an application to the High Court in Dublin next year to have the case
struck out on the basis that they have already offered a sum equivalent
to the highest amount he might have won. Grant says he will settle only
in return for an admission of liability. Several high-profile suicides
in America have been blamed on the drug. The teenage son of Bart Stupak,
a Democratic congressman, killed himself in 2000 while taking Accutane,
the American brand name for the medication. Following a political campaign
led by Stupak, government rules for the drug were tightened recently.
In January 2002 Charles Bishop, 15, killed himself when he crashed a plane
into a 42- storey Bank of America building in Tampa. Florida. Police were
said to have found a prescription for Accutane in Bishop's home, but the
coroner found no trace in his system. Bishop's family is suing Roche.
In Britain the Department of Health is considering a request that it undertakes
an examination of the medical records of up to 6,000 people a year who
committed suicide over the past two decades to establish how many of them
used Roaccutane. Campaigners against the drug believe that the exercise
would demonstrate a strong link between use of the drug and suicide.
However, a British firm of solicitors that received legal aid to pursue
litigation against Roche five years ago has now dropped the actions, believing
that the cases would be impossible to prove. "About 80 or 90 claimants
came forward but we had to report that we did not think the claims could
be won," said Mark Harvey, now a partner in Hugh James, the solicitors
in Cardiff. "You have to be able to link depression to the drug and it
would be difficult to prove that it might not have arisen anyway and to
eliminate other causes. Isn't depression a side effect of puberty or acne
in any event? It is going to be difficult to get the Legal Aid Board to
reopen this."
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