Rethinking research funding

Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, shows in his article below how full of anger at drug companies he is. Perhaps he thinks they have not given him all the presents he is entitled to. He is, however, bereft of ideas about how to improve on the present system.

He notes that, in spite of huge research efforts, new drug approvals have dropped off. He does not for a moment consider that the huge and ever-rising costs of getting a drug through the FDA approval process might have something to do with that. Leftists don't criticize bureaucracy. They LOVE bureaucracy! His solution to the problems he sees? Take money off the companies that produce the drugs -- thus making it HARDER for them to get new drugs approved!

His proposals (if we can call them that) are extremely fuzzy but he seems to think that governments can do it all! I wonder what he has in mind as an example of something that governments do well? His proposal is a simple Leftist kneejerk, untroubled by any evidence for its efficacy. It is true that governments already fund a lot of research but actually doing the research is a different matter entirely. Government business enterprises have been sold off worldwide in recent decades but dinosaur Avorn seems to want to create new ones!

THE BIOTECHNOLOGY Industry Organization is holding its annual mega meeting in Boston this week at a pivotal time in the industry's history. Medically, biotech is at the growing edge of therapeutics. Most older, conventional drug companies have become massive marketing engines with a dulled innovative edge -- only 18 new drugs were approved by the FDA in all of 2006. By contrast, many biotech companies retain their roots as research-based operations where the scientists' agenda can still compete with that of the sales department. Some of the most exciting new treatments for cancer, autoimmune diseases, and even vision loss are emerging from this creative new sector.

But amid the breakthrough findings, lavish entertainment, and self-congratulation that will fill the convention attendees' schedules this week, some important worries may not get the attention they merit. The first relates to costs. Not the cost of the luxury harbor tours and exorbitant meals that participants will enjoy in the coming days; I'm referring to what patients (or taxpayers) have to pay to get access to these wondrous discoveries.

Regimens that can cost tens of thousands of dollars a year per patient can cloud the moral judgment of those who purvey them. For example, a confluence of interests among biotech giant Amgen, for-profit dialysis centers, and kidney disease consultants seems to have led to substantial over prescribing of the company's flagship blood-building product, erythropoietin -- a lucrative practice that probably increases the risk of side effects and even death. Another dilemma: A new biotech product, Lucentis, can reverse the vision loss caused by macular degeneration, a devastating cause of blindness. But the drug costs $2,000 for each monthly injection. Many ophthalmologists are convinced that equally miraculous results could be provided to far more patients with use of a very similar biotech product, Avastin, at only $50 per dose. Yet Genentech, which makes Avastin, has not agreed to sponsor a clinical trial to study this possibility, which could also save Medicare hundreds of millions of dollars in the coming years. That's probably because Genentech makes both Lucentis and Avastin, and use of the more affordable drug would cut into the more expensive drug's expected profits.

Biotech has brought to market a number of important new cancer treatments. But pricing a lifesaving cancer regimen at over $50,000 is guaranteed to put that treatment beyond the reach of many patients. It doesn't cost anywhere near that much to produce these drugs. Rather, the industry argues that these sky-high prices are justified to fuel the expensive research it performs. But many biotech advances are heavily based on publicly funded research supported by the National Institutes of Health and by foundations. Current policies allow companies to charge whatever they want for a new drug, with no payback required for most of the indispensable, taxpayer-supported basic research that made it possible. With the federal deficit threatening to flatline the NIH budget for the first time in a generation, and venture capital speculators increasingly preferring to fund safer "late-stage" companies with nearly marketable products, savvy conventioneers this week must be worried about where the next decade's miracle cures will come from -- as we all should be.

The breathtaking five-figure prices that some biotech drugs command per course of therapy warrant a rethinking of this "trickle-down" approach to supporting science -- a strategy that amounts to the growing privatization of medical research. The example of biotech's older, flabbier siblings is not encouraging: Only about 14 cents of every dollar paid for Big Pharma's products makes its way back into research and development, according to the companies' own figures.

A safer course for the nation would be to take some of the billions the nation is paying for these expensive products and use it to rev up NIH funding, protecting the flow of scientific innovation on which new biotech products depend. The companies could then come in and do the hard work needed to bring those discoveries to market. They should be rewarded fairly, even handsomely for that important work -- but not at levels that will pauper the rest of us or the federal treasury. And we need a better way to provide reasonable compensation for the taxpayer-supported research on which breakthrough products are based. Public funding of university-based research, not extortionate drug prices, is the safest way to guarantee "the miracle cures of tomorrow." It might make for fewer luxury harbor cruises at future BIO conventions, but we can live with that.

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Yet another proposal about how to fix the unfixable

The NHS should be run outside politics by a board appointed by Parliament, the British Medical Association says. The NHS should have its own constitution and make clear that it cannot provide everything possible, focusing instead on core services that meet the needs of the great majority of patients most of the time, it says. These changes would prevent day-to-day political meddling and let patients know what they could expect, the BMA says in a discussion paper.

The plans arise from dissatisfaction among the medical community about the Government's reforms, James Johnson, chairman of the BMA Council said. There was "intense unhappiness" in the entire workforce, with reforms that lacked logic or coherence. Professionals had been marginalised by changes over 15-20 years, and the "constant dabbling" by politicians was dividing managers from clinicians, he said.

The recommendations envisage the NHS as an organisation that is a cross between the BBC and an old-style nationalised industry: run by a board, reporting to Parliament, and governed by a constitution that would set out principles, rights, and responsibilities. Patient input would be strengthened by greater local involvement, the division between purchasers and providers eroded if not abolished, and clinical leadership given greater priority.

Mr Johnson, a surgeon, said that the current reforms were "probably just about as unpopular as you can get. They lack cohesion; they are contradictory. "It is absolutely right the politicians set the guidelines, but day-to-day dabbling when a particular topic becomes headlines is not good for the service," he said. For the Secretary of State to have to react to every local eventuality "can't be the best use of Cabinet ministers' time. We think the way forward is for the service to be vested in a board of governors. The Government would set the amount of money and the general direction of travel for the NHS without any further interference." The board of governors would ensure compliance with the NHS constitution. It would appoint an executive management board, to include the NHS Chief Executive and Chief Medical Officer.

Some rationing of services appeared inescapable, Mr Johnson said, as treatments became more costly and the population aged. The list of services provided should be decided through debate between politicians, professionals and the public. Hamish Meldrum, chairman of the BMA's GPs committee, said that this did not mean the association favoured rationing. "We will continue to press for all necessary resources, but we do believe rationing may be inevitable. What we are recommending, if rationing is to take place, is that it's done in an open manner."

Andy Burnham, the Health Minister, said: "We resist any call to make the NHS a slimmed-down, emergency service, because that's what it would become if we started rationing care. The NHS should continue to be comprehensive and universal. Further independence within the NHS should be considered only if it improves services. We are already devolving decision-making. "

Andrew Lansley, the Shadow Health Secretary, thought the BMA was too pessimistic, and that bureaucratisation and demoralisation could be reversed. "I endorse some of the principles - taking politicians out of the day-to-day running of the NHS; reengaging professionals and focusing the Secretary of State and department on public health challenges," he said.

Nigel Edwards, of the NHS Confederation, which represents most NHS organisations, said that producing a written constitution would be extremely difficult. "The NHS exists in a cash-limited system and has a multitude of competing priorities," he said. "It is extremely difficult to reach a consensus on expensive drugs and treatments that pleases everyone. "We need to confront the reality that if the public do not want cost to be a factor in NHS decisions, they may have to prepared to pay more. "The confederation agrees that the NHS should be more independent of central government control. However, the structure of this is less important than ensuring devolution of power to local trust level."

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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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