NHS EYE DRUG DISGRACE

Who cares if you lose your sight? Not the bloated NHS bureaucracy!

Thousands of patients whose sight could be saved by a new drug are being denied treatment on the NHS on the ground of cost. Macugen, a new treatment for age-related macular degeneration, is launched today but primary care trusts (PCTs) are already telling patients that they will not pay for it. A quarter of a million people in Britain suffer from "wet" AMD, the form of the disease that Macugen can treat. Every year, 21,000 more people, mostly over 60, have this form of the disease diagnosed. But Macugen has not yet been cleared by NICE, the National Institute for Health and Clinical Excellence, and will not be for at least another year.

Specialists fear that many patients will go blind while they wait. The delay has been condemned by the Royal National Institute of the Blind (RNIB)which has given warning that many patients will lose their sight before a decision is made on approving the drug. "We already have evidence that this drug is not getting to patients because PCTs are hiding behind NICE, saying that they can't approve a treatment until NICE makes a ruling on its effectiveness, said Steve Winyard, head of research for the RNIB. "If this happens across the country then we are going to see many people lose their sight and their independence to do things like drive and go shopping, so we are urging health trusts to think long and hard before they say no to patients getting Macugen."

Ophthalmologists are excited by Macugen, the first of a new class of treatments that can attack the underlying cause of the disease. A second medicine, Lucentis, which some specialists believe will prove even more effective, is awaiting licensing in the US and Europe. But both are relatively expensive - Macugen costs 4,000 pounds per patient a year - and a NICE ruling on their cost-effectiveness is not expected until August next year. Kevin Gregory-Evans, a consultant at the Western Eye Hospital in London, said of Macugen: "This really is a major step forward in fighting AMD. "Previously we had very little to offer patients once the disease started to become active, and so severe loss of vision was an inevitable consequence of developing AMD. So to have an effective drug is absolutely marvellous."

Both drugs are monoclonal antibodies that target VEGF (vascular endothelial growth factor), a protein that helps the formation of new blood vessels. In the eye, high levels of VEGF can cause proliferation of blood vessels and fluid leakage, the characteristics of "wet" AMD. Sufferers begin to lose central vision, making it impossible for them to read or drive. Although they may retain sufficient vision for independent life, their quality of life is very seriously damaged. "Unlike glaucoma or cataracts, very few people have heard of wet AMD - yet it has a major impact on patients' daily lives, depriving them of their central vision, independence and ability to complete every day activities, such as driving, shopping and cooking," said Philip Hykin, Consultant Ophthalmologist at Moorfields Eye Hospital, London.

Macugen, made by Pfizer, is given by injections into the eye every six weeks.

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FDA to be bypassed to save lives?: "On May 2, a three judge panel of the D.C. Circuit recognized that 'a terminally ill, mentally competent adult patient's informed access to potentially life-saving ... new drugs ... warrants protection under the Due Process Clause.' The decision stemmed from a case challenging FDA regulations, which require experimental drugs to go through a lengthy series of FDA managed clinical trials before they are available to patients. That red tape can be a death sentence for patients in dire need, whose lives may well depend on access to the new medicine. Following some of the language of the D.C. Circuit's opinion, law professor-bloggers Jonathan Adler and Orin Kerr then described the case as a decision that recognizes a new 'right to experimental drugs.' A Washington Post editorial went further, charging that the D.C. Circuit pulled this right to experimental drugs 'out of thin air,' 'call[ing] into question the whole fabric of drug regulation.'

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

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