The groundswell for the licensing of the cancer ‘wonder drug’ Herceptin continues to build. Latest to fall in line are the European regulators, the European Medicines Agency, which has approved the drug in a record 27 days, and the UK authorities are expected to follow suit within the next few weeks.
The supposed grassroots support for the drug has been encouraged, and funded, by the manufacturer – as E-news No. 248 revealed – and already the pressure is growing to use the drug inappropriately.
Herceptin (trastuzumab) is designed to treat late stage, or metastatic, breast cancer that is fuelled by a protein called HER-2, which represents around 20 per cent of all breast cancer cases. Some advocates are keen to test the drug on women at an earlier stage of the disease, even though it will not be licensed for that use, nor have there been any safety checks for this group.
The hype started with the announcement of the findings of the Herceptin Adjuvant trial, which revealed that the drug could reduce the risk of recurrence of breast cancer in 52 per cent of patients. Prof Ian Smith, the lead investigator, commented: "This is the biggest treatment development in breast cancer, in terms of the magnitude of its effect, for at least the last 25 years, perhaps as big as anything we’ve seen."
So a legend was born, and the manufacturer decided to help it along by encouraging grassroots protests and calls for its adoption in the UK and Europe, even though the manufacturer hadn’t submitted any safety records.
Everyone had ignored the fact that the trial had been stopped prematurely, and the results had been skewed. The drug wasn’t saving lives, and it was no better than other cancer therapies after one year. A re-analysis of the data found that the drug was helpful – to some extent – in six out of 100 women.
Prof Smith has since moderated his position, and from being the most important drug in cancer treatment ever, it is now one with only marginal benefit.
This shift has gone unnoticed by patients, the media, politicians and, of course, by our ever-watchful regulators who are falling over themselves to approve a wonder dug that isn’t.