KEEP A COOL HEAD IN THE FACE OF HERCEPTIN HYPE
Times Online November 09, 2005
Lancet warns: 'Don't believe the Herceptin hype'
By Simon Freeman
An influential British medical journal today scorned claims that Herceptin was
"a cure" for breast cancer and attacked the hype - in Government and the media -
surrounding the treatment.
The Lancet said that insufficient evidence exists to be sure that the drug is
either safe or effective and warned that the Government's off-the-cuff decision
to bypass normal regulatory procedures was flawed.
The journal stepped into the row over patient access to Herceptin as a health
authority "revisited" its decision not to provide the drug for a mother of four
following the dramatic intervention of Patricia Hewitt, the Health Secretary,
yesterday.
Elaine Barber, 41, said she was "over the moon" today that her local primary
care trust had changed its mind and agreed to give her the £21,000 treatment,
avoiding a High Court challenge.
North Stoke PCT had previously argued that the drug's efficacy was unproven and,
on that basis, it was too expensive to fund its use.
That view is repeated in The Lancet which today argues that the case for giving
Herceptin to women with early Her2-type breast cancer is still not reliably
proven.
In an editorial published online today, the journal attacked the "hype" that
forces premature decisions to be made about treatments.
It criticised an editorial in the New England Journal of Medicine last month
which described Herceptin as "maybe even a cure". The article prompted Ms Hewitt
to announce that the drug should be made available on the NHS on demand even
though it has not completed approval trials.
The Lancet 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."
The availability of new treatments in England and Wales is largely determined by
the National Institute for Health and Clinical Excellence (Nice), which vets
medicines.
In March 2002, Nice recommended Herceptin for women with advanced breast cancer
who had the HER2 gene mutation linked to the disease.
The process leading to the decision was criticised as taking too long. Nice
insisted that its primary concern was providing reliable advice backed by
sufficient evidence. |
