For the second time this year, the Guardian leader column has attacked the "interference" of judges and government ministers in the provision of drugs that have not yet been approved by the National Institute for Clinical Excellence (Matters of Nice judgment, January 26; Meddling judges make it worse, April 13).
The Herceptin story has become one of "emotional" patients versus hard-pressed managers. But patients such as Ann Marie Rogers and myself have not demanded the drug because we're the gullible pawns of drugs companies and charities. We want it because our oncologists have told us that we need it - they don't think Herceptin is "hype-over-hope".
But the voices of those oncologists have largely been ignored. Instead much of the British press has relied heavily on an editorial published in the Lancet last November. The previous month, the New England Journal of Medicine had reported the results of three clinical trials involving nearly 12,000 patients: although accepting that the follow-up was brief and that there were still important issues to resolve, it declared the results to be "revolutionary". The Lancet, though, called for "a moment of caution", arguing that "the available evidence is insufficient to make reliable judgments," and that Nice should resist pressure "to make expedient decisions".
The Guardian clearly feels that "the oldest British medical journal" trumps its American rival. But this is not the view of "the bulk of medical oncologists". According to Professor Gordon McVie, senior consultant at the European Institute of Oncology and formerly director-general of the UK Cancer Research Campaign, they tend to be more international in outlook and much "less conservative" than many other physicians.
There is no space here to go into detail on all of the Guardian's presentation of data. But I would like to quote my own oncologist on one thing: for patients at the very highest risk, Herceptin (over and above other forms of treatment) gives about a 15% absolute improvement in overall survival at 10 years. He says: "The calculations and methodology underlying our estimations ... have been independently tested three times."
"It would be extraordinary," McVie says, "if such an obvious biological effect [as that produced by the Herceptin antibody] does not translate into improved survival rates."
The Herceptin story is not only important for breast cancer patients. It acts as a test case for many other drugs likely to emerge in the next 20 years. Numerous therapies precisely targeted at specific molecules are in development or trial. Unless something is done about the process of drug approval and funding, the unequal provision of unlicensed drugs is going to become increasingly common.
Of course, Britain is not the only country to have this issue. But France, Canada, Italy and the Netherlands (among others) have decided to fund Herceptin nationally in the interim period. By passing the buck to local primary care trusts, our government has accepted the return of post-code prescribing. That is why patients resorted to the courts, and judges were forced to "meddle" (or apply the law). There needs to be a clear national policy on the provision of drugs that are, or soon will be, "waiting for Nice".
· Kasia Boddy is a breast cancer patient whose treatment (including Herceptin) is funded by Cambridge PCT k.boddy@ucl.ac.uk
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