Re: "Hewitt steps into cancer drug row"
- From: quayman@xxxxxxxxx
- Date: 9 Nov 2005 11:46:10 -0800
Some more background for anyone interested:
http://news.bbc.co.uk/2/hi/health/4421312.stm
'Tread carefully on cancer drug'
Herceptin is not licensed for early breast cancer
The medical journal The Lancet has said claims for the anti-cancer drug
Herceptin should be treated with greater caution.
In an editorial, the journal argued the evidence on effectiveness and
safety is not yet reliable.
It warned political and media pressure should not undermine the usual
process of checking new drugs.
On Tuesday Health Secretary Patricia Hewitt ordered an urgent review of
a decision to deny the drug to a patient.
The best that can be said about Herceptin's efficacy and safety for
the treatment of early breast cancer is that the available evidence is
insufficient to make reliable judgments
The Lancet
North Stoke Primary Care Trust (PCT) told Elaine Barber it was not
convinced the drug was safe or cost-effective.
The Conservative Party has also called for national funding for the
drug until it has been fully reviewed by the NHS advisory body, the
National Institute for Health and Clinical Excellence (NICE).
Herceptin, which can cost £20,000 a year for a course of treatment, is
currently licensed only for use in women with advanced breast cancer.
However, recent clinical trials suggest the drug might also be
effective at treating women in the earlier stages of the disease.
NICE, which is to introduce a new fast track procedure for asssessing
potentially life-saving drugs, is primed to assess Herceptin for these
patients once a licence has been granted - but not before.
However, campaigners say the drug should be made widely available to
women who stand to benefit now.
Preliminary results
The Lancet said that studies into the effect of the drug on early stage
breast cancer had only produced preliminary results, from which it was
difficult to draw meaningful conclusions.
In its editorial, it said: "The best that can be said about Herceptin's
efficacy and safety for the treatment of early breast cancer is that
the available evidence is insufficient to make reliable judgments.
"It is profoundly misleading to suggest, even rhetorically, that the
published data may be indicative of a cure for breast cancer.
"Drug regulatory agencies and bodies such as NICE play an important
part in translating research evidence into clinical guidance.
"It is vital that their decisions are made carefully after considering
the totality of available evidence.
"They must be free from political, special interest, or media
influence, no matter how well meaning."
Assessment too slow
Pamela Goldberg, of the Breast Cancer Campaign, agreed that the debate
surrounding Herceptin had been influenced by the media, and other
opinion formers.
However, she said the debate had highlighted the fact that new drugs
were currently assessed too slowly.
"It will be some years before we know the long-term side effects and
benefits of Herceptin, but for some patients the short or medium term
will be what counts - there will be no long term benefit for those
women who do not survive."
Emma Taggart, of the charity Breakthrough Breast Cancer, said: "Many
cancer experts, who have looked at the recent trial data, want to
prescribe Herceptin for their patients and these decisions should
continue to be made on a case by case basis and based on clinical
judgement.
"Like any drug, Herceptin does have side effects and patients must be
fully informed of these so they can, in partnership with their doctor,
make informed decisions about their treatment."
Roche, which makes Herceptin, disputed The Lancet's claim that there
were holes in the recent research into the drug's impact on early stage
breast cancer.
HERCEPTIN FACTS
It targets the HER2 protein, which can fuel the growth of breast
tumours
Herceptin prevents this process happening
Around a fifth of breast cancers are HER2 positive
It is currently licensed for use in women with advanced breast cancer -
where the disease has spread within the breast or to another organ
Early stage breast cancer refers to the first occurrence of the disease
The cost for one year's treatment with Herceptin is £19,500
.
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