Releases Saturday 14 September 2002
No 7364 Volume 325
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(1) FORMER INSIDER HITS OUT AT FDA'S LINKS
WITH PHARMACEUTICAL INDUSTRY
(2) POOR
HEALTH OF GULF VETERANS NOT
RELATED TO
POST-TRAUMATIC STRESS
DISORDER
(3) HPV LINKED TO CERVICAL LESIONS
(4) VIRTUAL
FRIEND HELPS YOUNG ASTHMA
SUFFERERS
(1) FORMER INSIDER
HITS OUT AT FDA'S LINKS
WITH PHARMACEUTICAL INDUSTRY
(Alosetron: a case study in regulatory
capture, or a
victory for patients' rights?)
http://bmj.com/cgi/content/full/325/7364/592
(Editorial: Alosetron for irritable
bowel syndrome)
http://bmj.com/cgi/content/full/325/7364/555
A former senior consultant with the Food
and Drug
Administration (FDA) has criticised the
American
regulator's close relationship with the
pharmaceutical
industry. Interviewed in this week's BMJ,
he attacks the
FDA's decision to allow the re-marketing
of a
controversial drug.
Dr Paul Stolley joined the FDA in July
2000 to look into
the post-marketing safety of alosteron
(Lotronex), a
treatment for irritable bowel syndrome
manufactured by
GlaxoSmithKline. Within months he was
writing to his
superiors about a rising toll of adverse
incidents, including
ischaemic colitis, hospitalisation, surgery,
and deaths.
Glaxo Wellcome (as the company was then)
voluntarily
withdrew alosteron in November 2000, but
almost
immediately patient groups were pushing
for its return.
Stolley claims that his superior, Dr Janet
Woodcock,
accused him of "brow-beating" colleagues
about the
drug's risks. He also says other colleagues
concerned
about the drug's safety were pressurised
to "help get this
drug back on the market". Woodcock, however,
says
that alosetron is an example of how difficult
it is to
provide access to a risky drug for those
in greatest need.
On Stolley himself she says: "It's our
responsibility to be
dispassionate and not develop emotionally
based
positions".
In April a special advisory committee recommended
that
alosetron be remarketed on the condition
that it was
prescribed only by specially certified
doctors. Six weeks
later, however, the FDA formally re-approved
marketing
based only on "physician self attestation
of qualifications".
A number of the committee members are now
publicly
warning of a risk of more deaths and another
withdrawal
if the drug returns to the market later
this year. What
happens in America is likely to determine
whether the
company pursues approval for the drug
elsewhere in the
world.
Over the last ten years eight drugs have
been approved
by the FDA and subsequently withdrawn
for safety
reasons, prompting calls for an end to
industry funding of
FDA drug reviews. "It's getting its money
from industry
now and it's afraid to offend those companies",
says
Stolley. Glaxo and the FDA deny any inappropriate
influence over regulatory decision making.
Contacts:
Please note Dr Stolley will not be available
for interview
after Wednesday 11th September
Dr Paul Stolley, Professor Emeritus, University
of
Maryland, USA
Ray Moynihan, Journalist, Australian Financial Review
Michel Lièvre, author of an accompanying
editorial,
Associate professor at the Clinical Pharmacology
Unit,
Faculte de Medicine Laennec, University
of Lyon
Email: michel.lievre{at}upcl.univ-lyon1.fr
(2) POOR HEALTH
OF GULF VETERANS NOT
RELATED TO POST-TRAUMATIC STRESS
DISORDER
(The mental health of UK Gulf war
veterans: phase 2 of a
two phase cohort study)
http://bmj.com/cgi/content/full/325/7364/576
Most Gulf War veterans do not have a formal
psychiatric
disorder and rates of post-traumatic stress
disorder
amongst the group are low, finds a study
in this weeks
BMJ.
Previous population-based studies have
shown that Gulf
veterans report medically unexplained
symptoms such as
fatigue, difficulty sleeping, and irritability
more often than
other veterans. They are also more likely
to report
symptoms of depression and post-traumatic
stress
disorder.
Researchers at the Gulf War Illnesses Research
Unit set
out to investigate the possibility of
a relationship between
psychiatric disorders and unexplained
physical
disabilities. They sent health questionnaires
to veterans of
the 1990-1 Persian Gulf conflict, veterans
of the 1992-7
Bosnia peace-keeping mission and military
personnel
who had not been deployed in the Gulf.
Randomly
selected subsamples of respondents who
had been
deployed in the Gulf, along with respondents
from the
other groups who reported physical disability,
were
invited for further medical assessment.
The researchers
analysed the association between each
of the main
psychiatric disorders and disability status,
taking into
account factors such as age, sex, and
rank.
Only 24% of the Gulf Veterans who reported
having a
physical disability were found to have
a formal psychiatric
disorder (such as depression or anxiety).
The figures
were similar for members of the two other
groups. All
groups had rates for post-traumatic stress
disorder of
between 1% and 3%.
The research suggests that the mental health
patterns of
Gulf Veterans reporting physical disabilities
differ little
from those of other disabled veterans.
Whatever the
nature of Gulf veterans' symptoms, they
cannot be
explained by exposure to events conventionally
understood to be psychologically traumatic,
the authors
conclude.
Contact:
Khalida Ismail, Gulf War Illnesses Research
Unit, Guy's,
King's and St Thomas's School of Medicine,
London
Email: khalida.ismail{at}iop.kcl.ac.uk
(3) HPV LINKED TO CERVICAL LESIONS
(Type specific persistence of high
risk human
papillomavirus (HPV) as indicator
of high grade cervical
squamous intraepithelial lesions
in young women:
population based prospective follow
up study)
http://bmj.com/cgi/content/full/325/7364/572
Infection with humanpapillomavirus (HPV)
is linked to an
increased likelihood of cervical lesions
in women, finds a
study in this week's BMJ. The study, which
involved over
10,000 women, found that those who were
HPV positive
had a significantly increased risk of
developing low and
high grade cervical lesions compared to
women who did
not have the virus.
10,758 women aged between 20 and 29 years
of age
with no history of abnormal cervical cell
growth were
given a cervical smear on joining the
trial in 1991 and a
follow up smear test two years later.
Compared with
women who were negative for human papillomavirus
at
enrolment, those who were HPV positive
had a
significantly increased risk at follow
up of having
squamous intraepithelial lesions; a precursor
to invasive
cervical cancer. Similarly, women who
tested positive for
HPV at the second examination had a strongly
increased
risk of low and high grade lesions.
However, women were most at risk of developing
high
grade lesions if they repeatedly tested
positive to the
same high risk HPV type.
The researchers conclude that HPV positivity
precedes
and predicts future cervical high grade
lesions and that
type specific persistence of HPV was strongly
associated
with the development of high grade lesions.
In contrast
for low grade lesions there was no significant
difference in
the risk associated with being HPV positive
on both
examinations with different types of HPV
and having the
same HPV type on both occasions.
Contact:
Susanne K Kjaer, Senior investigator, Danish
Cancer
Society, Institute of Cancer Epidemiology,
DK-2100,
Copenhagen, Denmark
Email: susanne{at}cancer.dk
(4) VIRTUAL FRIEND
HELPS YOUNG ASTHMA
SUFFERERS
(Letter: Mobile phone text messaging
can help young
people manage asthma)
http://bmj.com/cgi/content/full/325/7364/600
Young people with chronic health problems
can benefit
from text message services, say researchers
this week's
BMJ.
Doctors in Tayside set up a mobile phone
text message
service combining reminders to use an
inhaler with sport
news, celebrity gossip, and horoscopes.
The messages
were sent by a "virtual friend with asthma"
to 30 young
asthma sufferers.
Focus groups before and after the study
found that the
content and style of the messages were
popular with the
volunteers, whose average age was 16.
Many of them
also developed a rapport with their virtual
friend and said
that they no longer forgot to use their
inhalers.
Text messaging can help people with chronic
health
problems to "make their disease comply
with their
lifestyle and not the other way around,"
the authors
conclude.
Contact:
Dr Ron Neville, general practitioner, Westgate
Health
Centre, Dundee
Email: r.g.neville{at}dundee.ac.uk
FOR ACCREDITED JOURNALISTS
Embargoed press releases and articles are available from:
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BMA House
Tavistock Square
London WC1H 9JR
(contact: pressoffice{at}bma.org.uk)
and from:
the EurekAlert website, run by the American Association for the
Advancement of Science
(http://www.eurekalert.org)
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