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Last Updated: Friday, 9 June 2006, 11:23 GMT 12:23 UK
Herceptin: Was patient power key?
By Sanchia Berg
BBC Today programme correspondent

Herceptin
Herceptin has proved effective in trials
The breast cancer drug Herceptin has been approved for use on the NHS for the treatment of early stage breast cancer.

The decision by the National Institute for Clinical and Health Excellence (NICE) was made in record time following an emotional campaign, and a number of high profile court cases.

It all began in May last year.

That is when US doctors indicated a trial of Herceptin on early stage breast cancers had been promising - and was also when Professor Lisa Jardine received a call.

She had been suffering from breast cancer, and had written that she might benefit from Herceptin.

The people who sit on our independent advisory committees are not for pushing around by anybody
Andrew Dillon

She said: "I was phoned within a day by somebody who asked if I would like help in getting my health service trust to get me Herceptin prior to NICE's authorising of it.

"I asked who this person was, and they told me they worked for a PR company working for Roche (which makes Herceptin).

"I was rather obviously outraged that the pharmaceutical company should be trying to persuade me to go public in trying to get the drug - which incidentally my hospital would have given me, should I have wanted it - and I hung the phone up."

Roche has defended the approach.

In a statement, it said: "Lisa Jardine, as a public figure who had spoken openly about her own disease, was contacted in the planning stages of activity to raise awareness of the importance of accurate breast cancer diagnosis.

"This activity was never conducted, as it was superseded by a Department of Health initiative to encourage wider tumour type testing."

Increased pressure

Just a couple of weeks later, a woman did go public on Herceptin. There is no indication the drug company helped though.

Barbara Clark is a former nurse whose primary care trust would not prescribe Herceptin for her early stage breast cancer.

I worried we were being rushed by patients
Professor Lisa Jardine

In June she told reporters she would sell her house to buy the drug herself - but three months later she was threatening legal action instead.

Her PCT finally said it would give her the drug - because of her exceptional circumstances.

But she wanted all woman with the same cancer to have the same chance.

At the time she said: "Those women when they've gone through their chemotherapy and radiotherapy will get their Herceptin. But what about the others like me?"

More women came forward. They too were suffering from early stage breast cancer and their primary care trusts would not prescribe Herceptin.

They too threatened to shame their local health authorities, either by selling their homes, or by taking their trusts to court.

Government intervention

Amongst them, was Elaine Barber from Stoke. She was finally told she could have the drug after an intervention by the Health Secretary Patricia Hewitt.

Patricia Hewitt
Patricia Hewitt intervened

That same month, in the US, the results of the trials were published.

They suggested that Herceptin could halve the chances of recurrence in early stage cancers.

The results were described as stunning by some.

However, Dr Richard Horton, editor of The Lancet medical journal, expressed concern.

He said there were key gaps in the evidence of the effectiveness of the drug - and question marks about whether it might in some circumstances damage the heart.

However, NICE, which has looked closely at the evidence, has now given the green light for Herceptin to be used for early breast cancer.

'Not rushed'

Professor Jardine believes Herceptin is a valuable drug.

She says its been used for early stage cancers in other countries.

But she has doubts about the way NICE reached its decision.

"I worried we were being rushed by patients.

"Patients are not, alas, in the end the best judges of what is best for the community of sufferers as a whole."

Andrew Dillon, chief executive of NICE, dismissed concerns that the assessment process had been rushed.

He said it was coincidental that Herceptin was among the first group of drugs to be considered under a new fast-track assessment system.

"We have introduced this new process precisely because we want to make sure that for potentially very exciting new interventions we are in a position to give advice to the NHS very quickly after that new drug gets its licence."

Mr Dillon said the drug would not have been approved if the evidence had suggested it was not effective or cost-effective.

"The people who sit on our independent advisory committees are not for pushing around by anybody.

"What they have come with today is entirely the product of their independent, reasoned interpretation of the evidence."

He said Dr Horton's concerns had been addressed by the full details of the clinical trials.

Mr Dillon said it was important for drug companies to minimise the amount of time taken to apply for a licence for potentially significant new drugs - particularly once public interest had been stimulated.




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