Roche Products on Nine Weeks funding for Herceptin

Response from Svend Petersen, Managing Director of Roche Products (New Zealand) Ltd to PHARMAC’s Announcement re: Nine Weeks funding for Herceptin / Clinical Trial.

For immediate release Friday, 16 February 2007

PHARMAC is misleading the New Zealand public and parliament about the nine week trial data. Roche is seeking an urgent meeting with the Minister of Health to discuss the implications of PHARMAC’s announcement. This has the potential to be this Labour government’s “unfortunate experiment”.

Internationally, there is no uncertainty about the optimum length of treatment with Herceptin. 23 OECD countries fund Herceptin for 52 weeks – New Zealand is the only country considering funding for nine weeks, and this is based purely on financial reasons.

Contrary to PHARMAC’s assertions, 52 weeks has been proven to save lives, nine weeks has not. The public should be aware that the results of any nine week clinical trial will not be available for several years, and in the interim thousands of New Zealand women will be exposed to an unproven, unregistered and experimental treatment regime.

The fact that PHARMAC feels the need to fund a clinical trial to support their decision obviously highlights their own uncertainty about the effectiveness of treatment for nine weeks.

This announcement makes a mockery of PHARMAC’s mandate to make decisions based on the strongest possible clinical evidence, and flies in the face of international opinion and best practice.

Four international clinical trials, involving more than 12,000 women have shown that more women survive when treated with Herceptin for 52 weeks. Only 232 women took part in the nine week trial, which showed no survival benefit.

Breast cancer is most likely to recur 18-24 months following surgery. This is why the four major international independent trials were designed with a 12 month treatment period. Ongoing studies are investigating the further benefit of 24 months treatment with Herceptin.

About Roche Roche Products (New Zealand) Ltd is committed to providing innovative products for cancer care in New Zealand. Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-orientated health groups in the fields of pharmaceuticals and diagnostics. Roche’s products and services address prevention, diagnosis and treatment of disease, enhancing well-being and quality of life. Roche employs some 62 000 people in more than 150 countries around the world. The company has business alliances and R&D relationships with numerous partners, including majority ownership interests in Genentech and Chugai, which are both members of the Roche Group.

Consumer Information

Herceptin (trastuzumab) is a Prescription Medicine used to treat patients with early breast cancer and metastatic (spreading) breast cancer who have tumours with a large amount of the HER2 protein. Tell your doctor if you have coronary artery disease, high blood pressure, heart failure, lung tumours or disease, or if you are pregnant or breastfeeding.

Possible unwanted effects: Common: chills, shivering, fever, nausea, vomiting, pain, stiffness, shaking, headache, dizziness, cough, skin rash, itchy skin, weakness, fatigue, abnormal or fast heart beat, insomnia, anxiety, depression, runny or blocked nose, cold/flu-like symptoms, chest infection, worsening cough, pain on urination, diarrhoea, hair loss, muscle or joint soreness. Serious: shortness of breath or breathing difficulty, severe cough, severe swelling of feet or legs, chest pain, abnormal heart beat, severe diarrhoea, feeling faint.

Ask your oncologist if Herceptin is right for you. Use strictly as directed. If symptoms continue or if you experience side effects or would like further information, please talk to your oncologist or visit www.medsafe.govt.nz for Herceptin Consumer Medicine Information. Herceptin (150mg and 440mg vials) is a funded medicine only for patients with metastatic (spreading) breast cancer who meet pre-defined criteria. A prescription charge and normal oncologist fees may apply.

ENDS

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