A report by the Expert Scientific Group into the trial has just
been published. Though the report has been called a whitewash by
lawyers acting for the men, Louise Fullwood, a lawyer specialising
in life sciences at Pinsent Masons, the law firm behind OUT-LAW,
denied that claim, and said that it could benefit UK companies and
universities.
"This is a sensible report, it is not a whitewash," she said.
Fullwood said that the report will benefit hospitals, bringing in
additional much needed testing and research funding.
"He is saying that when drugs are being given to people for the
first time it should be done in centres that are based either in
hospitals or in private sector units but based within or very close
to a hospital, so that you have intensive care and treatment
facilities and you need to have 24-hour medical cover there."
"Some of the private sector sites that are not necessarily that
close to a hospital are not necessarily the places to do
first-in-man testing, so that's good news for hospitals in this
country that have on site testing facilities or an ability to do it
in their own labs and their own wards because that's extra business
for them," she said.
"First-in-man studies of higher risk medicines should always be
conducted in an appropriate clinical environment supervised by
staff with appropriate levels of training and expertise, with
immediate access to facilities for the treatment and stabilisation
of individuals in an acute emergency, and with pre-arranged
contingency availability of ITU [intensive care / therapy unit]
facilities in reasonable proximity," said the report. First-in-man
studies are those in which a medicine tested on animals is given to
humans for the first time.
According to Fullwood, clinical research is a vital element in
research funding of hospitals and universities. "It's a big revenue
generator and it very much helps funding pure blue skies scientific
research in this country because researchers can get funds by
carrying out these trials which they can then use to carry out
perhaps more interesting pure research," she said.
The report dealt with the case of six young men who submitted to
voluntary tests of the drug TGN1412 at a private testing facility
at Northwick Park Hospital earlier this year. The test was carried
out by Parexel on behalf of TeGenero, a German firm that has became
insolvent because it was not fully insured against the adverse
affects of the test.
The drug was designed to treat rheumatoid arthritis, leukemia
and multiple sclerosis, but it caused a horrific reaction in all
six healthy men. They swelled up, in one case to three times his
normal body size, and some lost numerous fingers and toes. The men
have been warned that they have a greatly increased chance of
developing cancer and immune system disorders in later life.
The body responsible for the regulation of the sector is the
Medicines and Healthcare Regulatory Agency. "Clinical trials in
general have an excellent safety record, but it is important that
we learn the lessons from the TGN1412 incident," said its chief
executive Professor Kent Woods.
The Expert Science Group was appointed by the government to
investigate the process. Chaired by molecular medicine expert
Professor Gordon Duff, it found that a total overhaul of existing
rules was not needed, and that some of the problems in the
Northwick trial related to failures to follow existing rules.
"They did pick up on some problems with the trial itself but
they were where people were ignoring or not conforming with
existing regulation so it's arguable we don't need additional
regulation we just need people to pay attention to the ones that
are already there," said Fullwood.
The report is vital for the pharmaceutical testing industry, a
major UK industry that is seen as being reluctant to embrace
further regulation.
"The UK clinical research and pharmaceutical industry is one of
the best regulated in the world, it has very high standards, that's
why it takes 10 or 15 years to get a drug to market," said
Fullwood. "If the regulator were to slap on a whole new set of
regulations and make it even more regulated then there's a risk
that pharmaceutical companies would say it's no longer cost
effective to carry out research work in the UK, let's take it to
Latin America or somewhere that's less regulated and that would be
very bad for UK hospitals, universities and clinical research
organisations."
