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Healthy Skepticism Library item: 3264

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Meikle J.
Judge orders health trust to fund interim course of Herceptin for cancer patient
The Guardian ( UK) 2005 Dec 22
http://www.guardian.co.uk/medicine/story/0,11381,1672451,00.html?gusrc=rss

Keywords:
Herceptin


Notes:

Ralph Faggotter’s Comments:

Upping the ante in the ongoing Herceptin story- “ A high court judge yesterday ordered NHS managers to pay for a woman with breast cancer to have the unlicensed drug Herceptin …”

Included beneath this article are a number of lead-up articles covering the vexed issue of Herceptin availability in the UK.


Full text:

Judge orders health trust to fund interim course of Herceptin for cancer patient

James Meikle, Health correspondent
Thursday December 22, 2005
The Guardian

A high court judge yesterday ordered NHS managers to pay for a woman with breast cancer to have the unlicensed drug Herceptin until her legal challenge to require the health service to fund her treatment could be heard.

Ann Marie Rogers, 53, has borrowed £5,000 to start treatment privately, but cannot afford a year’s course of the intravenous drug, which is being administered every three weeks. She is seeking to force Swindon primary care trust in Wiltshire to pay for Herceptin, which trials have suggested halves the chances of the aggressive HER-2 form of cancer returning after a year.

Article continues
Two other women had threatened to take trusts to court over their refusal to fund Herceptin, but in both cases the trusts backed down. Several other trusts have agreed to pay for treatment if doctors think it will be effective.

The drug’s use for early stage breast cancer has still not been approved by the regulators, nor has it been appraised by the NHS for cost-effectiveness, but Patricia Hewitt, the health secretary, has told trusts that they must not refuse to fund treatment on the grounds of cost alone.

Mr Justice Charles, who considered Mrs Rogers’ application for a judicial review at the high court in London of the Swindon trust’s decision not to pay for Herceptin, said it should continue her treatment, pending the hearing. This may not take place until February 22. The judge said: “I appreciate that any decision made on an interim basis may be treated as a precedent for other cases, but I have to deal with this case as its stands before me.”

Mrs Rogers, who has two children, said: “I am thrilled with the result. I can now look forward to continuing my treatment, at least until the full hearing, when I hope they will find I should be given the complete course, as prescribed by my doctor.”

Each administration of the drug costs around £1,900, said Mrs Rogers’ solicitor Yogi Amin, of the law firm Irwin Mitchell. “The judge made clear this was a case of general and public importance. This case will affect all health authorities across the country and all patients affected by the ‘postcode lottery’ of drug provision.”

The trust maintained that it was following directions from its strategic health authority and cancer networks not to routinely fund the drug until it had been through the regulatory process and been approved by the NHS’s National Institute for Health and Clinical Excellence (Nice). In a statement, it said: “The PCT sympathise with Mrs Rogers and her family. Decisions on whether or not to support the prescribing of Herceptin are not made solely on the basis of cost. We await advice on prescribing Herceptin from Nice. Until this time we will continue to review every request on a case by case basis.”
—————————————————————————————————————————————————-

Woman makes Herceptin court bid

BBC, 21 December 2005

A woman with breast cancer has won the right to mount a High Court challenge against her local NHS trust’s refusal to give her the drug Herceptin. Swindon Primary Care Trust (PCT) had refused to pay for the anti-cancer drug to treat Ann Marie Rogers, 53. The refusal came despite the health secretary saying PCTs should not refuse to fund it solely on cost grounds. …………… http://news.bbc.co.uk/2/hi/uk_news/england/wiltshire/4548950.stm Patient wins Herceptin review Press Association – December 21, 2005 The NHS came under further pressure to increase the availability of the breast cancer drug Herceptin today after a woman won the right to a judicial review of her local health trust’s refusal to pay for the therapy…………….

http://society.guardian.co.uk/health/news/0,8363,1671990,00.html

Woman refused Herceptin funding

BBC, 21 December 2005

Swindon Primary Care Trust has refused to pay for the drug Herceptin to treat a woman who has breast cancer. Anne Marie Rogers, 53, of Swindon, had already applied to the High Court for a review of her case. The hearing is due to take place on Wednesday…………….

http://news.bbc.co.uk/1/hi/england/wiltshire/4548600.stm

Cancer patients win herceptin bid

BBC, 18 November 2005

Amanda d’Argue was refused the drug. Breast cancer patients in the early stages of the disease in Greater Manchester can now be given the drug herceptin, health chiefs have ruled. The decision comes after cancer patient Amanda d’Argue, 39, of Radcliffe, Bury, was told the drug was only licensed for use on sufferers with advanced cancers. The mother-of-two said this could prevent the disease returning, and appealed against the decision……………………..

http://news.bbc.co.uk/2/hi/uk_news/england/manchester/4449966.stm

British journal counters U.S. view of cancer drug

By Elisabeth Rosenthal, International Herald Tribune

november 9, 2005

NEW YORK Just three weeks after America’s most prestigious medical journal declared an expensive new cancer drug to be “revolutionary” and “maybe even a cure” for early breast cancer [The Lancet 2005; 366:1673, http://www.thelancet.com/journals/lancet/article/PIIS0140673605676702/fulltext ],

the most prominent British medical journal came to the opposite conclusion Wednesday.“The available evidence is insufficient to make reliable judgments,” editors of The Lancet wrote in an editorial published online Wednesday. “It is profoundly misleading to suggest, even rhetorically, that the published data may be indicative of a cure for breast cancer.” In a telephone interview, The Lancet’s chief editor, Dr. Richard Horton, said he was “quite angry” that Herceptin has been portrayed as such a wonder drug in The Lancet’s U.S. counterpart, the New England Journal of Medicine. “Study results are preliminary, inconsistent and raise extremely serious concerns about safety,” he said…………….

http://www.iht.com/articles/2005/11/09/news/lancet.php

Cancer patient’s Herceptin bid fails

8 Nov 2005
A woman suffering from breast cancer has lost her bid to get the lifesaving drug Herceptin made available to her on the NHS. Elaine Barbour said North Stoke primary care trust (PCT) refused to give her the drug, citing reasons of safety and cost-effectiveness. The mother of four now says she will take the PCT to the High Court to appeal against the decision……………

http://www.politics.co.uk/public-services/health/cancer-patients-herceptin-bid-fails-$15085750.htm ‘My fight for breast cancer drug’ By Sharon Alcock – BBC radio health correspondent 18 October 2005

Alison believes she could benefit from Herceptin. Alison Poole leapt out of the radio a fortnight ago when she was interviewed on BBC Five Live’s Drivetime Programme, as a woman with a compelling argument. She is one of a group with breast cancer who have been campaigning to be prescribed the drug Herceptin on the NHS………………..

http://news.bbc.co.uk/1/hi/health/4352276.stm Herceptin decision ‘breakthrough’ BBC, 18 October 2005

Herceptin is already used for patients with advanced cancer. More than 100 breast cancer patients in Cornwall and Devon could soon be prescribed the drug Herceptin. The decision by South West Peninsula Health Authority (SWPHA) follows the court victory of Somerset woman Barbara Clark to be treated with the drug………….

http://news.bbc.co.uk/2/hi/uk_news/england/cornwall/4354448.stm

Nurse wins breast cancer drug row
BBC, 3 October 2005
Barbara Clark was diagnosed with breast cancer earlier this year A former nurse has won her battle to get the breast cancer drug Herceptin prescribed on the NHS. Barbara Clark, 49, from Bridgwater, Somerset, faced having to sell her home to pay privately for the drug…………

http://news.bbc.co.uk/1/hi/england/somerset/4304586.stm

Fighting For Herceptin
Helen Thomas – A group of women in Staffordshire are fighting for breast cancer drug herceptin to be given on the NHS. Without it, the future for many of them is bleak. But the campaign is proving hard, distressing and long. Helen Thomas explains………………

http://www.bbc.co.uk/stoke/content/articles/2005/09/26/herceptin_intro_2005_feature.shtml

Herceptin – a diary
A group of Staffordshire women, most of whom have breast cancer, are campaigning for a cancer treatment drug, Herceptin, to be made available to those who need it, on the NHS. We’ve been helping log their story week by week……………….

http://www.bbc.co.uk/stoke/content/articles/2005/09/26/herceptin_diary_feature.shtml

nti-Cancer Drug Herceptin Associated with Significant Risk of Cardiotoxicity

Genentech Says Its Breast Cancer Drug Can Increase Risk of Heart Problems

The FDA and Genentech, Inc. have warned healthcare professionals by means of an August 2005 “Dear Doctor” letter of study data linking Herceptin (trastuzumab) therapy to a significantly increased risk of cardiotoxicity. This news was broadcast by an alert sent on August 31, 2005 from MedWatch, the FDA’s safety information and adverse event reporting system. Herceptin is indicated for use alone in chemotherapy-experienced patients, and with paclitaxel in chemotherapy-naive patients, for the treatment of HER-2–positive metastatic breast cancer. According to the Dear Doctor letter from Genentech, a preliminary analysis of the recent study data suggests that Herceptin can significantly increase the risk of heart problems. The increase is “significant” compared with patients who received only chemotherapy.

In more detail, the study of 2,043 breast cancer patients found a higher incidence of damage to the heart in the 1,019 patients taking Herceptin. Such damage can lead to heart failure and, in some cases, death. The August 2005 Dear Doctor letter from Genentech says:

http://www.fda.gov/medwatch/safety/2005/HerceptinDDL_0805.FINAL.pdf

“ A statistically significant increase in the 3-year cumulative incidence of . . . congestive heart failure and cardiac death was observed in patients who received the Herceptin-containing regimen, [amounting to 4.1 percent, compared with chemotherapy alone, which was put at 0.8 percent] “

The Dear Doctor letter says that Herceptin’s label already includes information about possible heart failure and heart ventricle problems. This recent study was intended to quantify the risk, according to the Genentech letter. Genentech stated in their August 2005 letter to doctors and other healthcare professionals that their analysis of the study results, which were first presented at a conference in May 2005, is ongoing.

 

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