Sydney Morning Herald - VIAGRA Hard choices
Monday, September 14, 1998
Viagra will be available in Australian pharmacies today; but whether it
is subsidised by the Government is a subject for hot debate. MELISSA
SWEET reports.
THEIR next meeting, in early December, will not be comfortable. The group
will be acutely aware, as they settle into their hot seats, of the intense public
interest in their private deliberations.
If proceedings follow their normal course, eight men and four women - all
doctors or pharmacists - will convene at their regular venue, a plush Sydney
hotel, to consider a multimillion-dollar question. Should taxpayers foot the bill
for Viagra?
The Pharmaceutical Benefits Advisory Committee (PBAC) is used to feeling
the heat; at different times, it has come under fire from patients, doctors,
politicians, the media and drug companies. Even so, Viagra is likely to turn an
even stronger spotlight on the committee, and on broader questions about
funding of pharmaceuticals.
Since its launch in the United States in March, the first tablet for treating
impotence has attracted unprecedented attention. Four million scripts have
been written in the US alone, with Pfizer selling $US411 million ($700 million)
worth of the diamond-shaped blue pills in the first three months. They are
expected to be on sale in 50 countries by the end of the year.
"The acceptance and interest in the product was probably greater than
anticipated," says a spokeswoman at the company's New York headquarters,
with studied understatement.
The drug, initially developed as a cardiac treatment, has become more than a
medical, financial or social story. It even has political ramifications.
There are still cynical chuckles around medical corridors about the premature
announcement of its approval by the Federal Health Minister, Michael
Wooldridge, and a "Viagra-led election".
Details about when Viagra will hit pharmacy shelves are due to be released
today at a Pfizer seminar. It will be addressed by impotence specialists, as well
as "Arthur", described on the invitation as a "loving husband and father, who to
the detriment of his family relationship suffered in silence for years".
Inevitably, public focus will next turn to whether the Federal Government will -
or should - subsidise the drug through the Pharmaceutical Benefits Scheme
(PBS). If it does not, experts predict tablets will cost $15-$20 each.
The PBS is already groaning under a rapidly expanding girth, with its costs
more than doubling this decade to reach $2.5 billion for 1997-98.
When established 50 years ago, it paid for almost 300,000 prescriptions. In
1996-97, it subsidised about 123 million scripts, and now accounts for about
15 per cent of the Federal health budget.
When the PBAC considers the Viagra application members will be conscious
of the public pressure, but be considering the broader public interest. They
must base their decisions on evidence about whether a drug is effective, cost
effective and how it compares with similar products. They also must consider
the harm caused by the condition, and impact on equity and hardship if a drug
is not funded.
Whether scarce health dollars should be used to promote erections is a fairly
straightforward issue for most impotence specialists, who are quick to note that
an injectible treatment is already on the PBS and therefore sets a precedent.
Like many GPs, they are fielding calls from patients eager to get the drug, or
have patients who have been importing it privately.
"Absolutely," says Dr Chris McMahon, director of the Australian Centre for
Sexual Health at St Luke's Hospital in Sydney, when asked whether Viagra
should be assessed in the same way as any other medicine.
"It's important for people to stop thinking about impotence as a benign and
innocent problem. Developed countries like ours need to realise that
State-funded medicine can also be about quality of life."
But, aware of potential for misuse, many specialists support restrictions on a
PBS listing, such as limits on the number of pills funded. In the US, Pfizer says
about half the health maintenance organisations pay for Viagra, but that most of
these impose a monthly limit of four to eight pills.
PBAC members are only too aware, however, of the exponential growth in use
of other drugs whose subsidised use is supposedly restricted.
Federal Health Department figures show, for example, that million scripts were
dispensed for proton pump inhibitors (to treat ulcers and related conditions)
last year under the PBS and the similar scheme for veterans, at a cost to
government of $187 million - a huge increase from 1990 when there were
14,500 scripts costing $1.6 million.
The subsidised use of these drugs is meant to be a last resort treatment for
ulcers and severe reflux oesophagitis, though there is widespread concern they
are being used more widely.
The new National Prescribing Service, which aims to encourage wiser use of
medicines by doctors and consumers, plans to target prescribing of these
drugs, so that more patients are given treatments to cure their ulcers rather than
to relieve symptoms.
The PBAC is also acutely aware of how costs tend to blow out with drugs for
common conditions, and several hundred thousand Australians are considered
possible candidates for Viagra.
Costs for cholesterol-lowering drugs called statins have soared to $234 million
for 5.4 million scripts last year, from 39,000 scripts costing about $2 million in
1990. Similarly, costs for the new anti-depressants, known as selective
serotonin reuptake inhibitors, have climbed from nil in 1990, to 2.7 million
scripts costing government about $89 million last year.
Of course, the role of the PBS is to ensure equitable access to worthy
medicines, and the PBAC as a general rule is prepared to spend
$30,000-$70,000 a year of life saved by a drug. But what if mushrooming
PBS costs mean other areas of healthcare miss out?
"If we spend more, we know we're stopping someone else having something,"
one committee member says privately. "Nobody's lobbying for these
unidentified "losers'."
Associate Professor Paul Glasziou, a clinical epidemiologist at the University of
Queensland and a practising GP, adds: "The whole healthcare budget will be
consumed by pharmaceuticals within a couple of decades at present rates of
growth."
He believes far greater scrutiny should be paid to how health dollars are spent
in other areas, claiming that most hospital spending is in response to lobbying,
rather than on evidence about what would be best for health.
Dr David Graham, head of the Federal Health Department's pharmaceutical
benefits branch, says the community, professions and governments eventually
will be forced to decide which drugs should be subsidised.
"There has to be more priority setting in the future. Where do you draw the line
on what is the government going to pay for? Do we want to put all our money
into oncology and asthma drugs?
"Safety will be another key consideration for the PBAC. In Australia, Viagra
prescribers and users will be warned that it should not be used at the same time
as nitrates, or by men for whom sex is inadvisable due to cardiovascular risk
factors.
(One concern is that many of those impotent due to vascular disease are likely
to be taking nitrates for heart disease. Conversely, there are concerns that
those with heart problems after taking Viagra may be given nitrates if the right
questions are not asked in emergency departments.)
US authorities have received 123 reports of people dying after taking the drug,
of which 69 have been verified. Many deaths are believed to have followed
heart troubles triggered by exertion, or adverse reactions with nitrate drugs.
But it is difficult to interpret such data because cardiovascular problems are
common in the age group most likely to use Viagra, and a voluntary reporting
system cannot answer whether it increases the risk.
There is widespread evidence of inappropriate use, which increases the risk of
harm, and a recent editorial in The Lancet concluded that these issues were so
serious, Viagra should be available only by hospital prescription in Europe.
Impotence specialists emphasise that clinical trials have not given any cause for
alarm about serious side effects, though some men will have problems such as
headaches and vision disturbances. Others note, however, that clinical trials are
often not representative of the broader population and there is a long history of
dangers emerging only with wider use once a drug is on the market.
For these reasons, Glasziou says the PBAC should consider listing Viagra for
some patient groups only as part of a large, controlled trial to answer ongoing
safety concerns. He believes the Government should be far more willing to fund
such trials, noting that many questions about drugs' safety and efficacy are
unresolved even after they hit the market.
It is ironic that while others can publicly canvass whether Viagra should be
funded, the PBAC is prohibited by legislation from publicly explaining its
decisions as they are based on data viewed as commercially confidential.
This lack of transparency is causing widespread concern, not least among
committee members who often feel under attack but unable to defend their
decisions. Negotiations with industry are now aimed at allowing more
information to be released.
Glasziou argues that this would help both doctors and patients better
understand committee decisions. It also would be valuable for hospitals which
now have to decide whether to fund drugs without having access to the PBAC
reviews.
There are also moves to restructure membership of the committee, which is
now dominated by Australian Medical Association nominees, to ensure a wider
range of appropriate skills. Belatedly, a consumer representative is about to
join officially.
Viagra is not the first drug to cause the PBAC headaches, and will not be the
last.
McMahon says there will be many more such treatments, including an
impotence-beating cream.
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