Releases Saturday 1 June 2002
No 7349 Volume 324

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(1) SCREENING FAMILIES WITH A HISTORY OF
HIGH CHOLESTEROL IS MOST COST EFFECTIVE
WAY TO CUT HEART DEATHS

(2) EUROPE BECOMING COMPLACENT OVER HIV
PREVENTION

(3) UNLICENSED AND OFF-LABEL PRESCRIBING IN
CHILDREN MUST IMPROVE

(4) SAFETY CLAIMS OF NEW ARTHRITIS DRUGS
MAY BE MISLEADING

(5) DO CELEBRITIES HELP SELL NEW MEDICINES?



(1) SCREENING FAMILIES WITH A HISTORY OF
HIGH CHOLESTEROL IS MOST COST EFFECTIVE
WAY TO CUT HEART DEATHS

(Cost effectiveness analysis of different approaches of
screening for familial hypercholesterolaemia)
http://bmj.com/cgi/content/full/324/7349/1303

Screening relatives of people with high cholesterol levels is
the most cost effective way to reduce deaths from
coronary heart disease, yet no recommended screening
strategy currently exists in the United Kingdom , according
to researchers in this week's BMJ.

High cholesterol which runs in families is known as familial
hypercholesterolaemia. About 110,000 people in the UK
are thought to have the condition, and at least 75% of them
are undiagnosed. Without identification and treatment, over
half of these people will have a fatal or non-fatal coronary
heart disease event by the age of 50 (men) or 60 (women).

Using computer modelling, the research team assessed the
costs and benefits of different screening strategies in the
UK. They found that screening family members of people
with familial hypercholesterolaemia was the most cost
effective way of detecting cases across the whole
population for all age groups.

This represents good value for money compared with
common medical interventions, say the authors. As no
recommended screening strategy currently exists for this
condition in the UK, they suggest that pilot evaluation
programmes should be conducted.

Contacts:

Margaret Thorogood, Reader in Public Health and
Preventative Medicine, or Dalya Marks, Research Fellow,
London School of Hygiene and Tropical Medicine,
London, UK
Email: Margaret.Thorogood@lshtm.ac.uk

(2) EUROPE BECOMING COMPLACENT OVER HIV
PREVENTION

(Are trends in HIV, gonorrhoea, and syphilis worsening in
western Europe?)
http://bmj.com/cgi/content/full/324/7349/1324

Rising levels of gonorrhoea and syphilis across western
Europe since 1995 imply that complacency over HIV
prevention efforts may have set in among individuals and
some governments, argue researchers in this week's BMJ.

Angus Nicoll and Francoise Hamers examined national
trends in diagnosed HIV infections, gonorrhoea, and
infectious syphilis from 1995 to 2000.

They found the numbers of new diagnoses of sexually
acquired HIV infections increased by 20% in western
Europe. Rates of gonorrhoea increased in France, the
Netherlands, Sweden, Switzerland, and the United
Kingdom, while outbreaks of syphilis have recently been
reported in several countries, especially among men who
have sex with men, including men already infected with
HIV.

These preliminary data show that sexual health has
deteriorated in parts of western Europe in recent years, say
the authors. Increasing numbers of people are living with
HIV, levels of sexually transmitted infections that facilitate
HIV transmission are rising, and sexual behaviour is getting
more risky. The danger is that HIV transmission rates
could increase again.

AIDS campaigns from the late 1980's and early 1990's
seem to have been forgotten and efforts to prevent the
transmission of HIV need to be strengthened, they say. In
addition to prevention measures, consistent surveillance
needs to be established across Europe to monitor trends in
key sexually transmitted infections, resistance of
gonorrhoea, and likely incidence of HIV transmission.

Contact:

Public Health Laboratory Service Press Office, London,
UK
Email: ecollins@phls.org.uk, sgregor@phls.org.uk

(3) UNLICENSED AND OFF-LABEL PRESCRIBING IN
CHILDREN MUST IMPROVE

(Off-label prescribing to children in primary care in
Germany: retrospective cohort study)
http://bmj.com/cgi/content/full/324/7349/1311

(Unlicensed and off-label drug use by children in the
community: cross sectional study)
http://bmj.com/cgi/content/full/324/7349/1312

(Unlicensed and off-label drug use by children in the
community: population based cohort study)
http://bmj.com/cgi/content/full/324/7349/1313

(Editorial: Off label prescribing in children)
http://bmj.com/cgi/content/full/324/7349/1290

Many drugs prescribed to children in general practice are
either not licensed for use in children ("unlicensed") or are
prescribed outside the terms of the product licence
("off-label").

Three studies in this week's BMJ show that unlicensed and
off-label prescription of drugs to children is common and
carries a high risk of adverse drug reactions.

In the first study, researchers in Germany found 13% of
prescriptions for a group of children in primary care were
off-label. The proportion of off-label prescriptions was
highest for 1-2 year olds and included drugs for heart
conditions, genitourinary disorders, and anti-inflammatory
agents. The authors conclude that efforts to improve the
quality of drug treatment in children should not exclude
widely marketed and firmly established drugs.

A second study by a team of Dutch researchers found over
22% of prescriptions for children aged 0-16 years were
used off-label. Drug groups with the highest proportion of
off-label use included oral contraceptives, and drugs for
eye and skin conditions. They argue that many licensed
drugs used by children in the community are poorly
labelled for use in children, resulting in high rates of
off-label use. Therefore labelling for children needs to be
improved.

Although unlicensed and off-label prescribed drugs do not
necessarily carry an actual threat to the health of a child,
the risk of adverse drug reactions is high, as adequate
dosing schemes have often not been assessed, according
to a third study. The authors conclude that this situation is
highly unsatisfactory, and efforts should be made to
improve it.

Contacts:

Lolkje de Jong-van den Berg, Professor of Social
Pharmacy and Pharmaco-epidemiology, University of
Groningen, Netherlands
Email: l.t.w.de.jong-van.den.berg@farm.rug.nl

or

Bruno Stricker, Professor of Pharmaco-epidemiology,
Erasmus Medical Center, Rotterdam, Netherlands
Email: stricker@epib.fgg.eur.nl

(4) SAFETY CLAIMS OF NEW ARTHRITIS DRUGS
MAY BE MISLEADING

(Editorial: Are selective COX 2 inhibitors superior to
traditional non steroidal anti-inflammatory drugs?)
http://bmj.com/cgi/content/full/324/7349/1287

(Editorial: Potential alternatives to COX 2 inhibitors)
http://bmj.com/cgi/content/full/324/7349/1289

Popular arthritis drugs, known as selective COX 2
inhibitors, may not be superior to traditional non-steroidal
anti-inflammatory drugs, conclude researchers in this
week's BMJ.

A study published in September 2000 concluded that the
COX 2 inhibitor, celecoxib, was associated with a lower
rate of stomach and intestinal ulcers than two older drugs
for arthritis. However, only data for the first six months of
the study were published. When all the data were
considered, the published results appeared to be clearly
flawed.

Two issues cause concern, say the researchers. The
authors' explanations for these serious irregularities were
inadequate, and the flawed findings published in the original
article appear to be widely distributed and believed by
many physicians.

They believe that an "industry independent" analysis of all
trials of selective COX 2 inhibitors must be performed to
include both published and unpublished data. They also call
for the wide dissemination of the misleading results of the
trial has to be counterbalanced by the equally wide
dissemination of the findings of the reanalysis according to
the original protocol.

"If this is not done, the pharmaceutical industry will feel no
need to put the record straight in this or any future
instances," they conclude.

The failure of this study may have more to do with the
design of the trial than with inadequacies of COX 2
inhibitors, suggest researchers at Queen's Medical Centre,
Nottingham in a second editorial. "Although it is extremely
important to highlight distortion of information, it is equally
important to recognise that the more information there is
the more issues can arise, and a lack of information can
easily nurture as many illusions as partial publication."

Contacts:

Editorial 1: Peter Juni, Senior Research Fellow,
Departments of Rheumatology, and Social and Preventive
Medicine, University of Berne, Switzerland
Email: peter.juni@bristol.ac.uk

Editorial 2: Professor C J Hawkey, Division of
Gastroenterology, University Hospital Nottingham,
Queen's Medical Centre, Nottingham, UK
Email: cj.hawkey@nottingham.ac.uk

(5) DO CELEBRITIES HELP SELL NEW MEDICINES?

(Reviews: Celebrity selling)
http://bmj.com/cgi/content/full/324/7349/1342

Last month, Camilla Parker Bowles made her first big
public speech on behalf of the National Osteoporosis
Society to raise awareness of the bone condition. In this
week's BMJ, journalist Ray Moynihan suggests that by
spreading the word about osteoporosis, she is
inadvertently helping to expand markets for new medicines.

The trend of using high profile personalities to raise
awareness about diseases is growing. In the US, Frasier
star Kelsey Gramer and his wife appeared publicly to raise
awareness of irritable bowel syndrome, while film and
television star Cybill Shepherd recently talked about the
menopause. Both campaigns were a huge success in the
American healthcare market.

Unlike the television stars, Camilla Parker Bowles is not
being paid by a drug or supplement company, but her
recent appearances talking about osteoporosis have
nevertheless attracted media attention, says the author.

They also appear somehow to be synchronised with a
much larger global campaign being underwritten by the
world's biggest pharmaceutical companies, he adds. The
commercial sponsor for the meeting at which Mrs Parker
Bowles spoke was Lilly, the manufacturer of a new
osteoporosis drug, and her "call to action" for early
diagnosis and prevention is based on a report sponsored
by eight global pharmaceutical companies. Lilly is the
"Gold Sponsor."

Intuitively, early diagnosis and prevention make perfect
sense, but the debate within the medical literature about
osteoporosis is far more complicated than these simple
measures reveal, says the author.

Although Mrs Parker Bowles paid her own way to the
meeting, by spreading the word about osteoporosis, she is
inadvertently raising awareness about the latest trend in
global drug promotion, he concludes.

Contact:

Ray Moynihan, Journalist, Australian Financial Review,
Sydney, Australia
Email: ray_128@hotmail.com


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