Crunch time for the NHS - will it pull through?

Reform of the health service is slowing just as it needs to intensify. If we don't accelerate now, billions of pounds will have been wasted, warns the top cancer consultant Karol Sikora

This month saw a blast of more bad news about our beloved health service. Too few nurses, too many doctors, no money, operations cancelled, another radiotherapy scandal, staff threatened with redundancy and entire hospitals going bust or being bailed out. Many must be wondering where all the taxpayers money that's been poured into the service has gone. After all, if you increased the budget of any commercial organisation from 34 to 84 billion pounds a year you would expect to see some dramatic improvements. But car parking is impossible, the loos still dirty and people sit around endlessly clutching pieces of paper when you can travel the world with an invisible electronic ticket.

I have worked in the NHS for 34 years, so it comes as no surprise. It's a large monopoly provider employing 1.4 million people that sometimes seems more responsive to staff needs than to those of its customers. Buffeted by the winds of political and social change, assaulted by a barrage of new expensive technologies, faced with consumers who are more demanding than their parents, it is now struggling for survival. And in 2008, current increases in NHS funding of 7 per cent a year dry up. So what is the solution?

It has to be reform. Not tinkering at the edges but pushing quickly forward with the bold plans already in place. Increased pluralism with new players providing innovative services will lead to real competition and a market driven approach. Novel ways of working will lead to greater efficiency, better motivation and allow staff to work together to drive innovation rather than whinge about the lack of it. The key is to get the multiplicity of professionals working together in the best way for patients. This will need to close but not intrusive management.

We have nothing to fear from further implementation of payment by results (PBR) - which simply means paying hospitals and GP's for what they actually do. It is exactly what happens in any other service industry. Imagine a supermarket that gets paid the same wad of money each week regardless of how much it sold. PBR changes patients from being service users to welcome customers. Consider high-street opticians. The old lady with her shopping trolley living alone on her state pension is as welcome as the girl about town in Prada and pearls who wants Gucci frames. Both come out seeing better. Can we not apply the same model to cancer and hearing aids?

The trouble is, as the think tank Reform recently pointed out, the whole process of change has slowed down just when it needs to accelerate. Waiting times in some areas have actually risen and novel rationing systems have emerged. There was an outcry from both left and right when a Department of Health report on workforce numbers was leaked. But these were probably only the back of an envelope of doodles by civil servants, rather than a serious assessment of demand, technology improvement, patient preference and skill mix.

The real issue is that by 2008 we should have moved from central to devolved planning. Local, not central, management should be deciding what staff to hire, what they should be doing, how many of what grade are needed and how much to pay them just as in high street shops. Real incentives for productivity, completely omitted in the recent, very costly, doctors' pay award, are vital in a pluralistic marketplace.

Stripping away bureaucracy to reduce costs is an essential component of therapy for the NHS. One report suggests that we are heading for a 7 billion deficit in the NHS by 2010 and that's not allowing for step changes in technology. That represents a 2p in the pound increase in income tax for everybody unless we can make things more efficient.

Major new investment capital is available from City institutions subject to robust business plans. The usual emotional statements of need or woolly wish lists simply won't do. Doctors hold the key. They can carry the other health professionals by providing decisive leadership. Getting good rapport between local medical leaders and managers is vital as is delivering services to patients in convenient settings rather than city-centre teaching hospitals, while retaining access to technological advances.

The NHS staff that I have known over many decades, have the talent, skills and education to make the transition. Whether it's dealing with a child with a complex leukaemia, a coach crash on the M25 or managing an elderly man with cardiac failure, we can do it as well as the best in the world. But only by intensifying the current reform programme will the NHS reform ever be got out of intensive care and sufficiently revived to make the long transition to a consumer-driven marketplace of health. Whatever our political persuasions, we must all surely agree that a speedy recovery is in everyone's interests.

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FDA puts a bandaid on its wounds

The Food and Drug Administration said yesterday that it is making changes in the way it operates to prevent the kind of drug safety controversies that have dogged the agency in recent years. Officials outlined plans to better monitor safety problems after drugs are approved and to make internal changes to increase the profile of agency scientists who raise red flags about drugs. The steps were announced in response to a report last year by the congressionally chartered Institute of Medicine (IOM) that called for an overhaul of the FDA's culture and structure following safety controversies over drugs such as the painkiller Vioxx.

Officials said the steps will restore the trust and confidence of Congress and the public. They also pledged a renewed commitment to good science as the best way to counter critics who say the agency is too cozy with drug companies. "We will fight back against those perceptions and that cynicism," said Steven Galson, head of the agency's Center for Drug Evaluation and Research, the division that evaluates new drugs and that has been at the center of the maelstrom.

A member of the Institute of Medicine panel said the FDA had taken steps in the right direction but had fallen short. "In a number of cases, the FDA does not go as far as the IOM recommendations, but they are first steps and in the right direction," said R. Alta Charo, a professor of law and bioethics at the University of Wisconsin.

A central contention of the IOM report was that the agency did not focus enough on monitoring drugs once they were approved. Most approvals are based on clinical trials involving a few hundred or a few thousand patients, and many uncommon side effects do not emerge until a drug is being used by millions. The IOM report said FDA officials who monitor drug safety were being ignored, because top officials were focused on approving new medications rather than monitoring those already on the market. "There was an asymmetry in esteem and funding between these two groups," Charo said. While the changes the FDA announced yesterday to integrate drug safety experts in the process were a start, she said, the agency's drug safety specialists still lacked power.

When FDA safety officials see a problem with a drug, Charo said, the agency is required to discuss proposed warnings, labeling changes or limits on distribution with the manufacturer. What FDA safety officials need, she said, is the power to impose fines and restrictions on companies that do not voluntarily follow the FDA's directives.

Agency officials said some of the changes proposed in the IOM report require congressional action, because they call for new powers. But officials also said they are starting a pilot program to produce report cards on some new drugs 12 to 18 months after their approval -- a process that would bring problems to light.

FDA Commissioner Andrew von Eschenbach and other senior officials said they were largely in agreement with the institute but called its report useful advice, not a blueprint. The agency is taking steps to break down internal walls and strengthen the role of safety specialists on advisory panels, they said. Referring to the IOM's concern about a "lack of respect" between agency staff who approve new drugs and those who monitor drug safety, Galson said, "We need to improve the way scientific disagreements are handled and resolved."

Besides the "cultural" issues within the agency, officials outlined a number of initiatives to better understand which patients may be susceptible to particular types of side effects, and which patients may be most likely to benefit from a particular drug. "This new science of safety will help us make products safer from the get-go," said Janet Woodcock, the FDA's deputy commissioner for operations.

The agency also said it is seeking alliances with the Department of Veterans Affairs, the Centers for Medicare & Medicaid Services and private insurers to gather better information about problems with using drugs and the challenges that physicians and patients encounter in the everyday use of medications.

Officials also promised greater transparency in how they select experts to serve on influential panels that assess new drugs and devices, as well as policy issues facing the agency. Some of these panel members have come under criticism for having ties to the drug industry. While greater transparency is a good thing, Charo said, the FDA also ought to limit the overall number of panel members who have conflicts of interest.

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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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