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Regulation of costly pharmaceuticals in Australia, England and New ZealandDrug appraisal is done through the National Institute for
Health and Clinical Excellence (NICE) in the UK, the Pharmaceutical Benefits
Advisory Committee (PBAC) in Australia, and the Pharmaceutical Management Agency
of New Zealand (PHARMAC) in New Zealand. Each use different criteria for public
funding of pharmaceuticals, but all include estimates of clinical effectiveness
and cost-effectiveness.
Interestingly of the 10 drugs deemed least cost-effective by
NICE between 1996 and 2005, all were approved for funding in the UK, 6 were
approved in Australia, and 5 were approved in New Zealand. It should be noted,
however, that the drug companies involved did not seek funding in New Zealand
for 3 of the drugs rejected in Australia.
So the PHARMAC scoresheet is 5 approvals and 2
rejections.
Med J Aust
2008;188:26–8.
Ovarian cancer and oral contraceptives (OCs)Combination OCs with low-dose oestrogen are hailed as the
very best form of contraception. It has been suggested that they may also low
the risk of subsequent ovarian cancer.
This paper from the Oxford Epidemiology Unit seems to
confirm this. They collected data for 23,257 women with ovarian cancer (cases)
and 87,303 without ovarian cancer (controls) from 45 epidemiological studies in
21 countries. The relative risk of ovarian cancer in relation to oral
contraceptive use was estimated, stratifying by study, age, parity, and
hysterectomy. Their conclusion was that use of oral contraceptives confers
long-term protection against ovarian cancer. These findings suggest that oral
contraceptives have already prevented some 200,000 ovarian cancers and 100,000
deaths from the disease around the world.
Very good news as ovarian cancer is common and usually
diagnosed when well advanced and incurable.
Lancet
2008;371:303–14.
Oral or topical non-steroidal anti-inflammatory drugs (NSAIDs) for chronic knee pain?Two papers in a recent BMJ compare the value of a
topical NSAID (ibuprofen gel) with oral use of the same drug for osteoarthritis
of the knee. And it seems that topical NSAIDs may be a useful alternative to
oral NSAIDs as the pain relief was about equal for both treatments except for
those with the most severe symptoms.
It would be expected that adverse effects would be less with
topical treatment but in these trials significant adverse effects were not seen
with either treatment.
An editorial commentary was favourable and pointed out that
a systematic review of a different topical NSAID found similar results and also
established that topical treatments are cost-effective.
On the other hand it also offered the opinion that placebo
effects explain most of the value of topical agents in osteoarthritis.
BMJ 2008;336:105–6
& 138–42 & 142–5.
Something else topical—lignocaine for pain relief in acute otitis media in childrenAcute otitis media (AOM) is a very common problem in
childhood with the majority of children having had the condition at least once
by their third birthday.
The routine administration of antibiotics for AOM has
recently come under scrutiny. The 2004 Cochrane review of antibiotics for AOM
suggests minimal benefit from early use, with no reduction in pain for 24 hours
and only a 30% reduction at 2–7 days. This report concerns a
placebo-controlled trial comparing the topical use of 2% lignocaine or saline
eardrops.
The results—rapid pain relief in the lignocaine group
at 10 and 30 minutes. Sounds good, but would probably require repeated
treatments and should be avoided in those with perforated eardrums.
Arch Dis Child
2008;93:40–4.
Ethics guidelines for clinical trials to be revisedThe World Medical Association is proposing to again update
its cornerstone statement of ethical principles regarding human
experimentation.
The main issue prompting this are the ethical problems
surrounding drug safety trials. One trial in particular resonated around the
world. It was a trial involving HIV-positive women in the developing world. It
gave one-half of all participants the drug azidothymidine to determine if a
shorter-course treatment would be as, or almost as, effective as the proven
longer-course treatment, and the other half a placebo, even though an existing
treatment was available.
The fault is obvious but some ethicists defended the trial
by arguing that the women would likely have received no treatment had the trial
not been conducted.
No easy solution here.
CMAJ 2008;178:138.
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