| 22.11,11. 05:11 AM |
Cancer drug needed more scrutiny
November 22, 2011
MEDICAL research should face more independent auditing to protect patients from ineffective treatments such as breast cancer drug Avastin, which may have done more harm than good, an oncologist says.
Dr Ian Haines yesterday said the much-hyped drug, which marathon runner Kerryn McCann campaigned for three years ago while she was dying of cancer, had been a waste of money since it was approved by the Australian Government's drug regulator in 2008. It had never been shown to extend patients' lives, he said.
Despite this, he said the drug, which costs patients about $3400 per month, had grown in popularity since its clinical trials were published in the New England Journal of Medicine in 2007, where it was hailed as an effective new treatment.
The large trial, which was partly funded by drug company Genetech, concluded the drug provided a median 5½-month increase in ''progression-free survival'', meaning 5½ months where the cancer did not appear to progress.
But Dr Haines said that when the United States Food and Drug Administration (FDA) reviewed the data, it found the drug did not extend the life of patients and noted ''significant protocol deviations'' in the original study published in the New England Journal of Medicine. This included missing radiographs used to assess patients' cancer status and a large number of incorrect dates for measuring disease progression in trial participants.
The FDA committee also disagreed with the original researchers' views on the cause of death of some trial participants and found a much higher rate of adverse events in the group of patients taking Avastin.
Further trials of the drug published last year found it did not increase patients' lifetime, and that there were significant side effects, including bleeding and high blood pressure.
Last week, the FDA banned the drug, saying it did not improve survival rates for patients with breast cancer and exposed them to potentially serious side effects. In response, Australia's drug regulator, the Therapeutic Goods Administration, is now reviewing the drug, which remains available to patients willing to pay for it. It has never been funded by the government's Pharmaceutical Benefits Scheme.
Dr Haines, who is also an adjunct clinical associate professor of medicine at Monash University, said the Avastin story showed that researchers' claims about drugs, based on drug-company sponsored research, needed to be carefully scrutinised by independent experts before they received the approval of regulators such as the FDA and Australia's TGA.
He said the New England Journal of Medicine article in 2007 had boosted the hopes of thousands of patients around the world, who would have since paid for the ineffective treatment, worth billions of dollars to its manufacturer.
Writing in the Medical Journal of Australia this week, Dr Haines and Dr George Miklos, director of Secure Genetics, said the case also demonstrated the need for medical journals to insist on publishing the raw data from clinical trials so it could be viewed by others without conflicts of interest.
A spokeswoman for Avastin manufacturer Roche said it would work with the TGA to provide any further information it needed. She said ''efficacy and safety'' were the company's highest priority.