Herceptin challenges put patient safety at risk, says survey
pharmafile | March 2, 2006 | News story | |
NHS managers have warned that the sidelining of the normal regulatory process for new medicines will put patient safety at risk, according to a new survey.
The NHS Confederation poll was commissioned in response to increasing pressure to make Roche's breast cancer drug Herceptin available to women with early breast cancer even though it is not licensed for this stage of the disease.
The survey of 168 NHS chief executives found that 78% thought patient safety would be put in danger and 91% thought less vocal patients or causes would lose out if the regulatory process is sidelined – as has happened in a number of high-profile cases involving Herceptin.
Chief executive of the NHS Confederation Dr Gill Morgan said: "We must not forget that Herceptin has not yet been licensed for treatment in early stage breast cancer.
"Yet PCTs find themselves under increasing pressure to prescribe the drug off-licence when its safety and effectiveness has not yet been proven."
Roche submitted Herceptin to European regulators for approval to treat early-stage breast cancer in mid-February, but PCTs have faced a barrage of public and political pressure for access to the drug as early as last autumn.
Early-stage breast cancer patient Ann Marie Rogers recently took Swindon PCT to court over its refusal to fund her treatment with Herceptin and lost, despite support for the case from breast cancer charities and government cancer czar Prof Mike Richards.
Dr Morgan said: "This case has shown the very difficult, and often heart-rending, decisions that doctors, nurses and managers in primary care trusts have to make every day."
The NHS Confederation represents more than 90% of NHS organisations and it is concerned that its members are being put in an impossible situation from growing pressure to bypass systems put in place to protect patients, she said.
Roche's Herceptin has been hailed as a wonder drug, with the latest trials showing potentially life-saving results in the early stages of the aggressive HER2 positive form of breast cancer.
The trials show a 50% increase in the chance of remaining cancer free if Herceptin is taken in combination with standard treatment, compared to standard treatment alone.
Although it has neither approval nor NICE backing for an early-stage indication the government has publicly stated PCTs should prescribe Herceptin wherever it is appropriate, and not use the high cost of the drug as a reason not to prescribe.
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