DOCTORS DRIVEN TO DESPERATE TACTICS

Doctors around the country are increasingly using methods popularized by labor unions to gain leverage in their fight against rising premiums for malpractice coverage. Over the past few years, their tactics have included large-scale marches, limiting treatment to emergencies or suspending service altogether. The doctors have not always been successful in gaining insurance changes, but experts say the pressure has helped move the issue up on the political agenda.

Maryland doctors have tried to galvanize support for changing how state courts judge damages in malpractice cases. Last month, about 50 doctors in Prince George's County declined nonemergency cases for a day. A similar number in Washington County refused to schedule nonemergency appointments for a week. In February 2003, most of New Jersey's 20,000 physicians took part in a slowdown for several days, canceling routine checkups and rescheduling elective surgery in one of the nation's largest walkouts ever by doctors. Emergency rooms were inundated with patients, and a rally in Trenton drew 4,000 doctors. About a dozen general and cardiac surgeons took "leaves of absence" in Wheeling, W.Va., in January 2003 as higher malpractice premiums came due, halting most surgery at three local hospitals.

In Maryland, the doctors have helped generate the pressure that led Gov. Robert L. Ehrlich Jr. to call a special session of the Legislature, set to convene on Tuesday. "There hasn't been a single state that's enacted major tort reform without physician job action," said Dr. Manuel A. Casiano, who has been practicing in Frederick for more than 15 years. Randall Bovbjerg, a researcher at the Urban Institute who follows malpractice issues, said physician activism "has become progressively more widespread" as managed care has squeezed doctors' reimbursements and made it harder to pass on their higher costs.

Doctors have traditionally concentrated on their medical practices and left the lobbying to professionals. But doctors say they now have little choice but to resort to direct action, especially as the influence of the American Medical Association has declined. Dr. Gregory Saracco, a surgeon in Wheeling, said that before taking action, doctors in West Virginia had been making little headway in getting the attention of state officials. "The governor wouldn't talk to us for a month," said Dr. Saracco, who was president of the Ohio County Medical Society at the time. "The day the leaves of absence started, I was in his office that very afternoon." The governor quickly put together a package to overhaul the system, and the surgeons began returning to work after two to three weeks.

Doctors are potentially subject to antitrust complications if they are seen to be colluding. They are careful to say they have made their decisions on job actions individually or within their practice. Carlton Carl, director of media relations for the Association of Trial Lawyers of America, a group that opposes doctors over changes in tort law, describes the doctor protests as strikes or job actions. "Clearly, this is an organized effort by the A.M.A. and state medical associations," Mr. Carl said. "It raises serious antitrust issues. And the denial of even nonemergency care is questionable for a doctor."

Source

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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.

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Fear Mongering At The FDA

First, let's get this straight: There's no new evidence that naproxen, the active ingredient in over-the-counter Aleve and prescription Naprosyn, causes an increase in heart attacks. There is, however, strong evidence that the U.S. Food and Drug Administration did the drug industry equivalent of yelling, "Fire!" in a crowded theater. On Monday, the FDA turned a halted clinical trial into a very scary warning about Aleve. As reported here on Tuesday morning, there was no reason for a warning, and, in fact, naproxen might well be safe.

The National Institutes of Health announced Monday that it had halted a clinical trial testing whether naproxen and Celebrex, an arthritis pill made by Pfizer, might prevent Alzheimer's disease. Another NIH study testing Celebrex as a cancer preventative had found that the drug increased the risk of heart attacks, and patients were dropping out of the Alzheimer's study in droves. Because of the worries about Celebrex and the problems holding onto patients, the Alzheimer's study was halted. In the Alzheimer's study, though, there was no increase in heart risk for long-term Celebrex users. There was a slight increase in heart risk for naproxen users, but the increase was so small that it may have been a chance occurrence. It was not the kind of data on which decisions involving many thousands of patients should have been made.

The FDA apparently didn't see it that way. In its statement, it said, "Preliminary information from the study showed some evidence of increased risk of cardiovascular events, when compared to placebo, to patients taking naproxen." Then it warned patients to use Aleve only according to the directions on the label--sensible advice, but ominous given the circumstances.

None of this would have sounded so scary if it weren't for Merck's recall of Vioxx, the biggest-selling drug ever to be pulled from the market. Vioxx works by inhibiting the same enzyme as Celebrex. When results emerged showing Vioxx doubled the risk of heart attack and stroke, scientists had been presenting clinical and theoretical arguments as to why Vioxx might cause heart problems for three years. No such wellspring of criticism exists with naproxen, which is marketed by Bayer as Aleve....

Even if it had been statistically significant--that is, not due to chance--the heart risk with naproxen was only about 50%, according to the NIH. In contrast, the negative results for Vioxx and Celebrex showed a doubling or tripling of risk--about the same increase in cardiovascular risk as with obesity or smoking.

More here

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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.

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The Painkiller Panic

Needed: A rational discussion on Vioxx, Celebrex and Aleve.

If there's silver lining to the sudden rash of unsettling news about painkillers, it's that just maybe it will force the American body politic to think twice about whether it really wants to destroy the pharmaceutical industry through an excess of litigation and reactionary over-regulation. If it were just Vioxx that caused occasional cardiovascular problems, after all, it would be easier to convince the ignorant and the opportunistic--i.e., likely jurors and Congressmen--that the FDA and the drug industry had erred so badly with a widely taken drug that truly drastic measures should be taken with both.

But now that Celebrex and Aleve (also known as naproxen) have joined the list of drugs that might--we stress might--cause cardiovascular problems, people may be forced to come to terms with the fact that all drugs have side effects, especially when taken in large doses and over the long term. We already knew that more than 15,000 people die--yes, die--annually from gastrointestinal bleeding caused by drugs like naproxen and ibuprofen, the side effect newer drugs like Vioxx and Celebrex were designed to avoid.

Of course, drugs also have huge benefits. And this page has long argued that in almost all cases the right people to weigh them against the risks are doctors and patients, not courts and regulators.

One of the most frustrating things about the latest news on painkillers is that almost none of the people reporting it understand the concept of relative risk--i.e., that a doubling of adverse events like heart attacks still doesn't mean that event is very likely. A doubled risk might well be a chance worth taking, especially if the baseline risk is low to begin with and the drug's benefits are significant for the patient in question. All of us implicitly accept this proposition with chemotherapy, for example, which poisons the entire body to kill a few cancer cells.

Why shouldn't we look at painkillers the same way? If you suffered from disabling arthritis and understood that your baseline risk for heart attack or stroke over a given time period was less than 1%, you might be willing to accept a doubling to a mere 1.5%. That's in fact what the study leading to the withdrawal of Vioxx in September found: 7.5 events per 1,000 in the placebo groups versus 15 per 1,000 among those taking the drug (and only after 18 months at a high dose).

Think patients don't actually approach their treatment this way? Consider Dave Ellis, who was featured in a Journal news story on Tuesday. The 66-year-old Mr. Ellis, who has suffered for 30 years from degenerative arthritis in his spine, says he dreads the day two months from now when his supply of Vioxx runs out. "If I look at the numbers, I just don't feel I'm at risk," said Mr. Ellis, who has no family history of heart disease. Is Mr. Ellis an ignorant rube duped by drug industry advertising? No, he's a retired pharmacist.

The numbers on Celebrex and Aleve are likewise no reason for unnecessary alarm. In one trial patients taking very high doses of Celebrex experienced a 2.5-fold increase in the rate of cardiovascular events versus those on placebo. Other studies, including the one now raising the alarm about Aleve, have shown no risk. In that trial--which had Aleve, Celebrex and placebo groups--patients on Aleve saw a 50% increase in cardiovascular events. But we're talking about only 70 events (including 23 deaths) out of a sample of 2,500 patients who were already over 70 years old. We don't even know yet if that's significant in a statistical sense.

There is no reason to assume the Aleve alarm will pan out in other studies. But one of the ironies here is that it shows there never was solid evidence to prove that older-generation anti-inflammatories of its class were safer than the newer Cox-2 inhibitors, as has been asserted everywhere in recent months by critics accusing the drug industry of pursuing profits on newer patented drugs when patients would have been better off taking generics. The likes of Drs. Marcia Angell, Eric Topol, and David Graham have been shown up for the Luddites they are, willing to make grand pronouncements about the public health with nothing more than their anti-industry reflexes to support them.

Meanwhile, Merck's decision to withdraw Vioxx is looking worse by the day. It was irresponsible vis-a-vis the public health because the drug provided relief some patients couldn't find elsewhere, and because the extreme measure has made a rational national discussion about drug risk that much harder. Withdrawal was also irresponsible toward Merck's shareholders because it has placed Vioxx in a different class when it comes to litigation--needlessly conceding the drug has no place in the pharmacopeia--from drugs that shouldn't be withdrawn but which may carry similar risks.

We understand our hopeful scenario above--that the latest news on Aleve may ultimately prove an antidote to anti-drug industry hysteria--may not be the way things pan out. For the moment, America's trial lawyers are emboldened by all the blood in the water. If there are many people outside this publication putting the risks in proper perspective, we haven't seen them.

But the possibility that Aleve (and who knows, maybe ibuprofen?) can have cardiovascular effects should change the political and legal environment in which the Vioxx drama plays out. By now just about every adult in America has experienced the near-miraculous healing powers of one non-steroidal anti-inflammatory or another for at least one episode of acute pain. We're guessing they won't want to find themselves without the option of relief should they ever be in pain again.

Source

[The above article would have made an even stronger point if it had mentioned that aspirin too has some dangerous side-effects -- such as stomach bleeding]

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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.

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BUNIONS TRUMP FRACTURED HIPS -- IN BRITAIN, OF COURSE

The arrogance and inhumanity of a welfare-State bureaucrat is worse than even a writer of fiction would dream up. Americans be warned!

"A surgeon, David Grace, had a backlog of 16 urgent cases. These included six people with broken hips. Now a broken hip is a serious and very painful injury. It does, of course, immobilise you. You have to lie still. You are in absolute agony unless you are very strong painkillers. This, I suspect, is not very good for anyone but especially for the elderly women who are most prone to break their hips. The condition causes them and their families fear and worry. If you are left hardly able to move for hours or days on end, you have a high risk of bed sores. This is, without doubt, an emergency. The operation to fix the hip should take place within a day or two.

So David Grace had six of these cases and 10 other cases to deal with. He went to the chief executive of his hospital trust and asked for help in clearing this backlog. She was insistent that he should not do so. She demanded that, instead, that he should operate on bunions. Grace believes - and it is hard to think of any other explanation - that this was because the chief executive wanted to meet a government target for treating non-urgent operations within nine months.

I would ask anyone to consider how they would feel if, say, their elderly mother or grandmother was lying in agony in hospital and she was left to wait for six days or more because the trust insisted on treating bunions? It is beyond shocking. It should make us think about the widespread assumption that the "public service" ethic is really so profound and reliable. Heaven help those who rely on the NHS. Heaven forgive those who expect the poor to do so.

Next time a cabinet minister boasts about reduced waiting lists, remember these six people with broken hips, lying in bed in agony, waiting to be treated in order to achieve the boast of which the minister is so proud.

But it gets more worrying still. For his impertinence is refusing to do what the chief executive told him, the trust leaned on him. An investigation was started into his 'personal and professional conduct'. He has since been exonerated. But think of the implication: that trying to treat those who need emergency treatment is not merely discouraged, it is likely to damage your whole career".

From the Adam Smith Blog

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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.

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Drug regulations cause millions of deaths each year: "Over-reaching FDA regulations have caused the premature deaths of millions of Americans, according to research scientist Mary J. Ruwart, Ph.D., who also said federal regulations passed in 1962 are responsible for more than 80 percent of the cost of today's prescription drugs. Ruwart, who is senior instructor with Burnet, Texas-based Sci-Com and adjunct associate professor of biology at the University of North Carolina in Charlotte, presented her findings on November 8 before the 2004 annual meeting of the American Association of Pharmaceutical Sciences in Baltimore, Maryland. Instead of protecting Americans from unsafe drugs, Ruwart said, 'these particular regulations, the 1962 Kefauver-Harris Amendments, have proven to be more deadly than all of the drug toxicity that occurred before their
passage.'"

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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.

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

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YOUR GOVERNMENT DEMANDS THAT YOU SUFFER

"A Virginia doctor has become the latest victim of the government's crusade to enforce federal drug laws that make it difficult for sufferers of chronic pain to obtain effective medication able to ease their distress. Dr. William E. Hurwitz may face life in prison for prescribing medication to sufferers of chronic pain as a result of the federal government successfully prosecuting him ...

A very large number of Americans -- some estimates run as high as 50 million -- suffer from recurrent, often debilitating pain. Hurwitz was one of the leading advocates of prescribing very high doses of pain medication necessary to relieve their suffering.

In the case, the government took the position that Hurwitz was running a "pill mill" for profit and that it was necessary to prosecute him and other pain doctors in order to stem the growing use of OxyContin and other potent prescription painkillers. Prosecutors claimed that Dr. Hurwitz fraudulently earned about $900,000 from 1999 to 2002, by supplying prescription narcotics to 500 pain patients. He charged a $1,000 initiation fee for each patient plus monthly fees between $150 and $250. But the government glossed over the fact that, for this modest fee, Hurwitz's patients had 24-hour access to his services and they never paid him for any of their drug prescriptions. He screened them for drug abuse and, indeed, required that they sign a treatment agreement which included drug testing. He dropped patients for non-compliance or for re-selling the drugs he prescribed.

None of the three patients' deaths were attributable to Hurwitz's treatment or drugs prescribed by him. One patient's death is not even claimed to have been drug-related; it was caused by the underlying disease of pancreatitis. Another patient's death was undetermined and the third case was due to a tragic error committed by a pharmacy that dispensed morphine instead of the drug that Hurwitz had prescribed.

It was a small criminal element among Hurwitz's largely blue collar patients whom he was trying to help that scammed him. Once they were arrested, they turned against Dr. Hurwitz in a plea agreement with the government to escape punishment. Dr. Hurwitz's compassion greatly assisted the government prosecutors. He did not immediately cut off patients he discovered were addicts or had criminal histories. He took the position that the abrupt termination of pain medication needed by patients would be "tantamount to torture." Unfortunately, that was exploited by some.

As a consequence of the Hurwitz trial, doctors will now view every pain patient they see with suspicion and as a potential criminal or undercover government agent. Pain patients will now find it even more difficult to find a doctor willing to treat them and risk the fate of William Hurwitz.

More here:


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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.

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MERRY CHRISTMAS!

To all those who come by here on this great day

And may all those who recognize Jesus as Lord always walk in his wisdom

The danger of too much caution: "If we are to balance drug safety, innovation in research and development, and the availability and price of new medicines, we must find a way to make regulators accountable for costly errors of all kinds. One way would be to create a vigorous, independent agency ombudsman that could compel regulators to act in the public interest. The office would have to possess the following attributes: (1) independence from the agency and the FDA commissioner; (2) access to independent expertise in relevant disciplines, including medicine, pharmacology, science, regulation, and law; and (3) the power to levy sanctions against FDA employees found to be responsible, individually or collectively, for flawed decisions or policies that constitute severe, avoidable errors."


Banning competition won't get us better hospitals: "Something very odd is happening in the hospital industry. A relatively new kind of hospital, called the specialty hospital, is emerging that seems to be more efficient and produce better health outcomes than existing general hospitals. But instead of welcoming this innovation, policy makers are trying to ban the innovation. Specialty hospitals are typically smaller than traditional general hospitals and focus on a few specific areas of care such as orthopaedic surgery or heart care. They typically offer a higher level of care than general hospitals because specialization allows them to be more effective and efficient."

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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.

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

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WHY THE FDA MUST BE MORE OF A HINDRANCE THAN A HELP

In his recent op-ed essay for 'The New York Times' (December 21, 2004), Goozner advances some of the classic myths about government. First, he tells us, "To make rational choices, doctors and consumers need the F.D.A. and other agencies to be independent arbiters of not just the safety and efficacy of new drugs and devices, but of their relative medical usefulness and economic viability." He continues his myth-perpetuation by announcing that "the medical oversight system needs a new ethic-one that scrupulously adheres to a standard that says its studies and decisions have been made entirely free of commercial bias and conflicts of interest."

Our true believer in the power of government to solve all our pharmacological problems quickly gives a hint as to why it is all a dream: "Sadly, that is very far from the situation today. Drug and device companies sponsor most clinical trials; F.D.A. advisory panels are larded with scientists tied to private companies; corporate user fees help finance the F.D.A. that is conducting reviews; doctors get most of their medical information either from sales representatives of drug companies or corporate-sponsored continuing medical education; and the companies are given primary responsibility for post-marketing safety surveillance of their own products."

Goozner mentions these obstacles to the possibility of impartiality and objectivity of government policy-making as if they were something only in place "today." And thus he charges ahead enthusiastically with the na‹ve notion that "To break these ties, there needs to be an independent arm of F.D.A. that contracts with independent clinicians and scientists for the final testing of all new drugs and medical devices." He proposes that "After a company submits its drug application based on safety and early efficacy trials, this arm would design the protocols to learn not just if the new drug is effective versus a placebo, but how it compares to other therapies and how it can be most effectively used. At the same time, the F.D.A. agency would need an adequately financed post-marketing system that would follow through on a drug's safety, using information and financing independent of the drug manufacturers."

These are all pseudo-noble notions and while they fall way short of justifying what the F.D.A. is supposed to be doing at its idealistic best, there is an omission in Goozner's discussion that amounts to out-and-out malpractice: He fails to discuss either the very famous argument of economist Sam Peltzman, of the University of Chicago, concerning the drug lag problem or the Nobel Prize-winning idea of Professor James M. Buchanan of George Mason University called "public choice theory."

Anyone who still has the temerity to propose that government is the solution to problems associated with drug manufacturing and marketing has the moral and professional obligation to discuss these two basic objections to such an idea. The drug lag argument shows that even following the intentions of the legislators who created the Food and Drug Administration, the results are going to be disastrous. Yes, one can always call up such rare victories as the banning of thalidomide (though even this one is no slam dunk when the details are considered). But as Aristotle taught us some 2600 years ago, "One swallow does not a summer make."

In fact, the F.D.A.'s policies produce even greater health hazards than anyone could imagine it averting. The reason is pretty simple: By insisting on certain types of tests for drugs that are being slated for manufacture-routinely requiring the impossible of proving a negative ("No one will be put at risk from this drug")-Americans are often prevented from gaining access to very effective means to fend off life-threatening diseases. The country thus lags behind many others and only those rich enough to visit these others are able to overcome this obstacle to their likely medical recoveries.

The merits of this argument are, of course, in the details. Yet it has gained considerable credibility over the last five or so decades and anyone who promotes greater powers for the F.D.A. needs to discuss it. The same holds for Buchanan's theory of public choice, one he developed with Gordon Tullock in their book, 'The Calculus of Consent' (University of Michigan Press, 1962). In 1985 Buchanan received the Nobel Prize in economics for this work and anyone who is proposing that outfits such as the F.D.A. can escape the inherent problem of bias would have to address his work.

Contrary to the suggestion by all those who propose to solve problems via government-namely, that all we really need is better people and more stringent rules-public choice theorists argues that inherent in the process of government regulation we invariably find the triumph of vested interest. Bureaucrats, including the most honorable scientists who might be hired to work in government agencies, are inclined to bolster their own special purposes and goals-some call this their "selfish interests"-and the way the welfare state works there simply is no way to curtail any of this. The dynamics of the nearly-unbound democratic system are such that government must respond to those in the constituency who exert the most clout. This is the most natural way of its operation. So it is sheer fantasy to hope that new people or rules will manage to circumvent it all.

But, instead of at least hinting at such problems with his proposal, Mr. Goozner charges ahead zealously, failing to raise any of the well-established skeptical concerns with what he wishes for, holding out the myth of government regulators as "independent arbiters."

Source

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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.

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

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VIOXX: AVOIDING A STUPID RESPONSE

Merck’s recall of Vioxx has led to calls for reform of the FDA’s drug approval process. While it’s true that the FDA’s approval process should be changed to better insure the health of all Americans, the question is what kind of reform is needed. In order to make the drug approval process more effective, we must first understand the problems facing the pharmaceutical market.

Many critics of the pharmaceutical industry point to the sale of “unsafe” drugs and the delay in recalling drugs, such as Vioxx, as an argument for creating a PASDA or “Post Approval Drug Safety Agency” to continue monitoring drugs after they have hit the market. Others believe that FDA policies make approval too difficult, not too easy. Every scientist who has studied the FDA carefully has found that delays in approval, mostly since the FDA policy change in 1962, which required approval for effectiveness as well as safety, have led to increased numbers of deaths. That is, more people have died waiting for drug approval than have been saved by having “safer” drugs available. One estimate is that the benefits of FDA safety regulation are between 500 and 1000 injuries (not deaths) avoided per year, while the cost of FDA delay is between 2,100 and 12,000 lives lost per year because of the unavailability of useful drugs during the approval process.

Patients have also lost out because the expense of drug approval means that some other wise promising drugs will not be worth developing at all. And the high cost of the FDA approval process, about $800 million per approved drug, means that once approved, drugs are more expensive than would be the case if the FDA process were quicker and cheaper.

If the response to the Vioxx episode leads to increased delays and costs in approval of new drugs, then this real problem in the industry will become worse. More consumers will suffer because of slower approval of new drugs, and some will suffer additionally because some drugs will not be worth inventing and developing, given the high cost of the process. The cost and hence the price for approved drugs will also increase.

An additional problem that many see in the pharmaceutical market is the high price of drugs, particularly the difference in price between the United States and Canada. While there are many reasons for this difference, one study has found that about one-half of the disparity in price is caused by the higher cost of litigation in the U.S.

These three problems-delay in recalling harmful drugs, slow and expensive approval of new drugs, and price differentials caused by litigation-seem unrelated, but they could be solved by a coordinated set of policies:

1. Create a PADSA, with the responsibility for monitoring drugs that have been approved and removing harmful drugs such as Vioxx from the market. Such drugs would then be recalled sooner, and any harm would be limited.

2. Because there would be less danger if a harmful drug is approved, since the PADSA would detect harmful drugs sooner, there would be less need for pre-marketing scrutiny of drugs, and we could return to a situation where the FDA examined drugs for safety but not effectiveness, allowing the market and the PADSA to determine which safety-approved drugs would be sold. This would lead to more drugs being developed and sold, and to lower prices for drugs. The PADSA would ensure that the overall safety of drugs would not be reduced.

3. Finally, because the PADSA would remove harmful drugs from the market, we would not need to rely on tort lawyers to discover unsafe drugs. Thus, the role of the tort system could be reduced, and FDA approval could become a “safe harbor” protecting approved drugs from lawsuits.

This set of coordinated policies, adopted together could go a long way towards improving the functioning of our pharmaceutical market and could provide more drugs at lower prices and reduced risk for consumers. If handled properly, the Vioxx incident could lead to reforms that will provide great benefits for consumers; if handled poorly, it may lead to great harms.


Source

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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.

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

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FDA SHOULD STICK TO MONITORING SAFETY

They might get it right if they did

Is anyone watching the store? Consumers ask that question when it appears that no one is accountable for how a business is being managed. It's a question many now ask about how the Food and Drug Administration (FDA) monitors drug safety.

On Friday, the maker of Celebrex announced that the pain reliever might be linked to increased risks of heart attacks and strokes - the same issues that caused Vioxx, a drug in the same class, to be withdrawn. More than a dozen of the world's most popular medicines have been challenged this year by new studies and scientists who say the FDA is failing to protect the public. The stakes couldn't be higher. Vioxx alone may have caused more than 30,000 deaths, David Graham, an FDA whistleblower and safety expert, told Congress last month.

To be sure, all drugs carry risks. But how much trust can Americans have in the FDA when a government survey finds that two-thirds of its scientists lack confidence that the agency adequately monitors safety, and 18% say they'd been pressured to recommend a drug over their reservations?

The FDA's job is to make sure the benefits outweigh the risks and that physicians and patients are aware of both. But the agency often operates in the dark, particularly after a drug is approved, putting the public at risk. It has seven times the number of employees working on new-drug approvals than it does on safety issues after a drug is OK'd.


Source

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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.

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

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USELESS BUREAUCRATIC OVERSIGHT OF PUBLIC HOSPITALS IN JAPAN

Pointless to expect openness in Japan, I suppose

Recent revelations of a failure to report several cases involving heart patients who died after surgery by the same doctor illustrate defects in the current system in which medical malpractice must be reported to the directors and other administrators of hospitals. Investigations at Tokyo Medical University Hospital following the deaths of a number of patients after heart valve operations were conducted only at departmental level, including that of a joint committee from the surgical and internal medicine departments. The department's investigations concluded the deaths were not caused by malpractice, a hospital insider said.

Because the four deaths were judged not to be the result of "incidents that caused actual harm due to improper medical practices," it was deemed unnecessary to report them to the hospital's director or an official responsible for safety management. However, it was abnormal for four patients to die in a short period after undergoing the same operation involving the same doctor, and the doctor in question was removed from the surgery roster for heart valve operations after the death of the third patient. With this in mind, it should have been natural for the hospital to have further examined the cases.

The system for internally reporting medical errors in hospitals was established in April 2000 by the Health, Labor and Welfare Ministry in the wake of a series of medical accidents. The system was imposed on university hospitals and other designated medical institutions providing advanced treatment, together with an order to improve guidelines on safety management.

The series of medical accidents caused by malpractice in university hospitals included a 1999 case at Yokohama City University Hospital, in which a mix-up caused two patients to undergo the wrong operations. It should be a matter of course in any organization that serious accidents are reported to senior officials. But in university hospitals, it is said that professors maintain a stranglehold over their departments and cannot be overruled by hospital directors. In the event of malpractice, it is not unusual for investigations to be handled entirely within the department responsible for the mistake. If a hospital's senior management does not know the details of an accident, it is impossible for the hospital to properly respond to the patients or their families, or take measures to prevent the mistake's recurrence.

The system of internal reporting is the first step to prevent malpractice, and has been obligatory for all hospitals since October 2002. The ministry is planning to introduce an experimental system whereby third-party organizations examine cases in which patients die during treatment. But the new system can work only if the internal reporting system is operated properly. If a hospital as a whole does not know of a malpractice case, it is impossible to bring it to the attention of a third-party organization.

More here

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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.

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

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DEALING WITH THE COSTS OF AGING

Dan Perry, executive director of the Alliance for Aging Research, described the looming challenge of an aging population as a "tsunami of health care costs." He noted that although the debate over health care typically narrows during an election season, Americans must look to the decades ahead. "Seventy-seven million baby boomers are aging, with the first wave eligible for Medicare in six years. Promoting health and independence for older Americans must be a priority."

Mortality rates continue to drop, said Perry, in response to new health care technology and better awareness of personal actions that can sustain good health. The actual number of disabled elderly was significantly lower than projected over the past 20 years, he noted, which resulted in lower costs than expected. But Perry warned that $26 billion in hidden health care costs can be expected to arise from a coming decrease in the ability of older Americans to care for themselves--an ability that declines quickly after age 80. By 2030, he said, nursing home costs could reach $190,600 per bed per year.

Those numbers point to one imperative: "We have to control these diseases," Perry stressed. "Shifting costs won't solve this problem." The good news, Perry said, is that Americans have high expectations for medical research. "They value it and are willing to pay for it. Medical schools and research universities are often the pride of their communities. We must energize our best minds, reduce the impact of disease, and make the U.S. the engine of innovation for the world."

Money spent on technology and research is considered well spent by the American public because it works to avert the impact of numerous diseases. Whether the innovation is as simple as the benefit of taking a daily aspirin, or an advanced product breakthrough such as cholesterol-lowering drugs, ACE inhibitors, and cancer medications, the success of such research is tangible....

Perry believes the rest of this century will bring a series of medical breakthroughs. For example, he expects researchers to find ways to control and possibly reverse Alzheimer's and Parkinson's diseases, with 20 drugs currently in development for each of those ailments. Cures for many cancers will become available, he said, and risks for cardiovascular disease will be identified and targeted for specific preventative interventions.

John Miall, risk manager for the city of Asheville, North Carolina, talked about applying such a model to an entire community. He observed that the incentives in the heath care industry all have to do with someone being sick. He suggested aligning the incentives with the well, encouraging people to stay healthy. The citizens of Asheville, he said, know something about this idea. In an undertaking called the Asheville Project, the community collaborated to improve the conditions of people with chronic diseases. Using diabetes as a chronic condition that needed attention, pharmacists in Asheville were offered a curriculum and certificate to learn hands-on care--foot exams, eye exams, and blood pressure tests--for their customers with diabetes. The state waived co-pays for drugs and glucose testing materials. This established a relationship between the patients, the pharmacists, and the physicians, a constant feedback loop that improved the level of care, Miall said. In the eight years since the Asheville Project began, costs for diabetic care decreased greatly, from $6,127 to $4,651 per patient per year. The project has grown to include many more participants and other chronic diseases. "Sometimes," Miall concluded, "you have to build systems that don't exist."

Dan Garrett, senior director of the medication adherence program for the American Pharmacists Association Foundation, helped implement the Asheville Project. To manage chronic care effectively, he said, health care must be local, and there must be self-management. The person with the condition has to manage the disease.

Fifty percent of all prescriptions written are not filled or not taken, according to Garrett. People with a "silent disease" such as diabetes or heart disease need to understand the importance of taking care of the condition. Local networks of pharmacists need the motivation, training, and time to help patients manage their care. "Align the incentives," he urged, "improve the outcomes, and control the costs."

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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.

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Nationalizing compassion: The Canadian Free Lunch

Say what you will about the evils of price rationing in the context of the health care market, but it does offer two huge advantages: It imposes discipline on the consumption of health care and it yields incentives for providers to continue providing in the long run. We do, after all, care about the children, do we not?

Actually, a close look at the hard reality of the bureaucratized health care system in Canada (and the UK and elsewhere) reveals that they care about the kiddies a good deal more than they might care to admit. Resources are limited. Ditto for government budgets. And so choices have to be made, notwithstanding the dual fictions that health care is "free" and that those who need it will not be denied. Someone has to be denied, and guess who that is increasingly: the elderly. Why "waste" expensive procedures and devices and medicines on someone who is going to some eternal reward relatively soon when a far more deserving (read: politically defensible) patient also is on the waiting list?

Alas, it does not, it will not, it cannot stop with the elderly. "Free" health care in Canada means that waiting lists are long, patients deteriorate while waiting, such "cheaper" devices as plastic artificial knees are used in place of aluminum ones, and those who can travel and pay for medical care go to the U.S. And those who cannot? Well, they suffer. As day follows night, health care will be denied the mentally ill, the desperately tiny prematurely born, those whose prospective "quality of life" in someone's politicized view will be inadequate. That is the tragic road toward which nationalized compassion inexorably will lead. This is not because the system is afflicted with correctible inefficiencies or because budgets are not fully funded or because doctors/hospitals/pharmaceutical producers/insurers/bureaucrats/name your goblin are greedy/corrupt/uncaring.

It is because "free" health care cannot overcome the basic and eternal condition of mankind: Wants exceed resources. And that in a nutshell is why a Canadian-style system is not the answer for the U.S. health care problem, notwithstanding the romanticized illusions now prominent in many discussions.

Nor is improvement to be found in a continuation of the creeping bureaucratization of U.S. health care. Instead, ways must be found to discipline demand. The Medical Savings Accounts incorporated in the recent Medicare reform bill are a step forward; they move somewhat toward a system in which people purchase health care services not with Other People's Money, but with their own. More such movement toward market mechanisms is the path toward true reform, which will serve the broad long-term interests of consumers, in that a "cheap" but huge medical sector leaves fewer resources and thus higher prices for everything else.

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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.

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AMAZING! OFFICIAL RECOGNITION OF AMERICA'S MEDICAL REALITIES

Competition Is Needed in Health Care, FTC/DOJ Study Says

A recent report by the Federal Trade Commission (FTC) and the Department of Justice (DOJ) calls for greater competition in the U.S. health-care system. The study found that "prerequisites for fully competitive [health-care] markets are not fully satisfied." In other words, our nation lacks a truly competitive medical system.

The 361-page report, "Improving Health Care: A Dose of Competition," addresses several key issues of particular interest to Health Freedom Watch readers. The study points out that consumers have better information about the price and quality of automobiles than they do about most health-care services. "It is difficult to get good information about the price and quality of health care goods and services," the study notes. "Without good information, consumers have more difficulty identifying and obtaining the goods and services they desire."

State licensing also was examined in the report. "Empirical studies have found that licensing regulation increases costs for consumers," the study notes. "There are fewer studies on the impact of licensure on quality, and these studies have found mixed results....[However], studies consistently have found that state-based licensure can harm consumer welfare by serving as a barrier to provider mobility."

(Summary of: "Improving Health Care: A Dose of Competition" July 2004, Federal Trade Commission/Department of Justice)

Source

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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.

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LAWSUITS ARE KILLING US

A recent commentary in The Weekly Standard observed, "Vaccines are the one area where trial lawyers are almost completely responsible for the problem. Lawyers have won the vaccine game so completely that nobody wants to play." Although there are other factors that discourage vaccine R&D, including the FDA's over-regulation and the Centers for Disease Control and Prevention's extortionate demands on manufacturers for huge discounts, fear of lawsuits is a major deterrent.

In spite of a generally high level of quality control in the industry and intense scrutiny by the FDA, drug and vaccine manufacturers are tempting targets for litigation. The threat of liability suits—even in the absence of evidence of any wrongdoing or product defect—makes these companies wary, but it also shifts their focus from whether the product actually is safe to how vulnerable the product is to lawsuits. A perfect example is a drug called Bendectin, which for many years was an excellent treatment for the morning sickness of pregnancy, until the manufacturer stopped selling the drug in the United States.

Safety problems? Unprofitability? Not at all. Frivolous, debilitating lawsuits killed this drug and relegated American women to munching crackers and quack cures. During the 1970s and 1980s, almost 2,000 lawsuits were filed, alleging that Bendectin had caused birth defects. Not a single judgment went against the manufacturer, but Bendectin was pulled from the market because of fears that an unreasonable and hostile jury might someday award huge damages.

To return to the flu-vaccine fiasco, the entire U.S. flu-vaccine supply is now made by only two companies, neither of which is in this country. This reflects an ominous trend. From 1967 to 1984, the number of U.S. vaccine manufacturers fell from 37 to 15, while the number of FDA-approved vaccines declined from 380 to 88. There are now only four major producers and a few dozen products, reflecting that government policies and litigation have conspired to make vaccine development a low-profit/high-(financial) risk endeavor. Fewer vaccine manufacturers means less vaccines for everyone, less resilience in the industry, and more illness, as in the current flu threat.

Runaway litigation also drives up costs for health care, makes doctors practice medicine defensively and stifles innovation. A study by Price Waterhouse Coopers said it best: "In the last 20 years, personal injury lawyers have found litigation against health-care providers and pharmaceutical manufacturers to be a lucrative growth area in their practices. Litigation that has enriched personal-injury lawyers, however, is adversely impacting both the quality and the cost of health care for the rest of us." ("The Factors Fueling Rising Health-care Costs," April 2002)

The scare tactics used by some personal-injury lawyers trolling for clients frightens patients off their medications, discourages doctors from prescribing others and causes parents to withhold vaccinations from their children. How can we possibly have quality health care in such an environment? Fixing the problem won't be easy, but hugely disproportionate legal liability is a drag on national competitiveness and detrimental to public health. Such a state of affairs in the United States is nauseating. Or maybe I'm just getting the flu.

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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.

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Most OB-GYNs sued at least once; settlements costly

About 70 percent of Maryland's obstetricians and gynecologists have been sued at least once, with the average settlement exceeding $1 million, a study shows. The report — titled "Medical Malpractice: Is It Time for Tort Reform in Maryland?" — also says that the average malpractice insurance premium for state OB-GYNs will reach $150,000 this year, though there is no evidence that those physicians were negligent. "That is not atypical for the United States," said the study's author, Michael I. Krauss, a professor at the George Mason University School of Law who specializes in tort reform and legal ethics. "There are some states that are above 70 percent. Maryland's crisis is not an anomaly."

Maryland doctors have said a 33 percent increase in malpractice insurance premiums this year will force them out of the state or out of business. Premiums were increased 28 percent last year and 10 percent in 2002. The 23-page study examines various aspects of medical malpractice and tort reform, including caps on jury awards, "no-fault" compensation and limits on attorney fees. It concludes that Maryland would benefit from tort reform, noting that the state's previous reforms have had a "real impact" on medical malpractice cases. "I am saying, 'Let's understand what tort law is about in order to able to reform medical malpractice,' " Mr. Krauss said. Mr. Krauss said he opposes a proposed state-sponsored fund that would cover doctors' higher premiums but supports caps on noneconomic damages such as pain and suffering. His study was published by the Maryland Public Policy Institute, a nonpartisan research and education group based in Germantown.

The state's largest medical malpractice insurer — the Medical Mutual Liability Insurance Society of Maryland — has said it is suffering from a surge in malpractice payouts. The insurer, which covers about 6,000 doctors statewide, has been authorized to increase premiums by 33 percent on Dec. 31.

State officials are said to be considering using $30 million to $50 million in taxpayer funds to cover the higher premiums this year. Gov. Robert L. Ehrlich Jr., who has led the reform effort, has not publicly discussed the cost or indicated how he would pay medical insurers. But the Republican governor has said no money from the state's general fund will be used and he will not consider a tax on health maintenance organizations that would generate about $80 million. Mr. Ehrlich is working with Democratic legislative leaders to craft tort-reform legislation for a proposed special session of the General Assembly this year.

Source

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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.

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HATRED OF SPECIALTY HOSPITALS

Want to hear some good NPR hatred of private service provision? Listen to this audio link. If the link does not work directly, you can get to it via here.

Since the Reagan administration abolished government controls over what hospitals can be built, lots of specialty surgical hospitals are springing up that give far better service than the public hospitals -- Urology Centers, Orthopedic Hospitals, Rehab Hospitals etc. So guess what anybody who has enough insurance prefers?

But the public hospitals are squealing about the "unfair" competition. Any idea of upgrading the public hospital service is not heard, of course. And with the government money they get should they not be able to give the private centers a run for their money? The private centers get no government money. We of course know why the public hospitals are totally out of any such race: Their huge and stifling bureaucracies.

So what is the beef that the public hospital chiefs have? Their claim is that the private clinics are stealing "their" patients! They say that it is the public hospitals that should be getting the money from the patients served by specialty centers. Since the USA is not a Communist state yet, however, this concept of "owning" someone will hopefully get the short shrift it deserves.

But what a typical example of Leftist authoritarianism the whole concept is: If you cannot compete with a better-organized competitor, get the government to shut your competitor down! That is what the public hospitals are asking for.

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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.

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THE BONEHEADED BRITISH ANSWER TO BUREAUCRATIC FAILURE? MORE BUREAUCRACY!

The British love their bureaucracy. The measures proposed in a report on Britain's first serial killer GP are likely to prove more damaging, to both doctors and patients, than the activities of one deranged doctor.

Of all the absurdities currently guiding UK government health policy, the notion that an intensive inquiry into the work of Britain's first GP serial killer provides the basis for a comprehensive reform of medical practice surely takes the biscuit. The measures proposed in Dame Janet Smith's report, published yesterday, are likely to prove more damaging, to both doctors and patients, than the activities of one deranged GP.

Dr Harold Shipman was convicted in January 2000 of killing 15 patients while working as a GP in Hyde, near Manchester. Later investigations suggested he may have killed as many as 215 patients. He committed suicide while in prison in January 2004.

Dame Janet Smith's 1,300-page report on Shipman accuses doctors in the General Medical Council of 'looking after their own', rather than making patients' interests a priority, and makes 100 recommendations for the reform of the profession's regulatory procedures. While she admits that, even if all her proposals were implemented, this could not guarantee that another GP serial killer would be detected, she believes that the chances of another Shipman appearing would be much reduced.

Given that Shipman was the first serial killer to appear since the emergence of general practice in the mid-nineteenth century, the chances of any repetition of such bizarre events must be regarded as remote. Yet medical practice is now to be regulated on the assumption that any doctor is a potential mass murderer whose malign intent must be exposed at the earliest opportunity.

Because of her focus on Shipman, in her assessment of contemporary medical practice, Dame Janet identifies the wrong problem. The problem is not that serial killers are lurking in GP surgeries; nor is it that most doctors are, like Shipman, arrogant and paternalistic. The real problem is that doctors in recent years have become increasingly diffident and lacking in confidence.

Far from being paternalistic, doctors are reluctant to take responsibility for making clinical decisions, often using the formalities of 'informed consent' to pass the burden back to the patient. This is in part attributable to the climate of scepticism about medical science and distrust for the medical profession that has been nurtured by opportunist politicians and cynical intellectuals. It has also been encouraged by the defensive response of the leading figures of the medical establishment who, far from 'looking after their own', have made concession after concession, even staging show-trials - such as the GMC Bristol inquiry - in an attempt to appease public prejudices.

Dame Janet approves of the trend for increasing lay participation on the GMC, but insists that it must go further, ending the medical majority on its governing body and hence the principle of professional self-regulation. But how does a lay majority protect the public? One of the most memorable moments in the Shipman story was the wave of protests from his patients when he was first suspended from practice. The fact that this mass murderer was, in his own community, a popular and respected GP suggests that patients are not necessarily the best judges of the professional standards of their doctors.

This is confirmed by the long history of charlatans and quacks who appear highly plausible to the public, but not to experienced doctors. The medical profession established the GMC to set a higher standard of practice than could be achieved through the market: a competent doctor had to satisfy his peers, not people without professional expertise. It is true that the statutory authority given to the GMC has contributed to the social and financial success of the medical profession. It has also, despite the periodic appearance of doctors who were corrupt, incompetent or lecherous, and despite too the clubbish ineptitude of its procedures, contributed to the gradual improvement in standards of medical practice.

The problem is not that recent GMC reforms have not gone far enough. The problem is that they have been moving in the wrong direction. Instead of surrendering control over the profession to members of the public - who will be appointees of the government and thus not in any sense representative of, or accountable to, the public - we need a medical leadership capable of providing a robust defence of the profession and its expertise.

The real threats to standards of medical practice are not surgery serial killers, or even the minority of idle and incompetent practitioners that has always made up a proportion of the medical profession (as of every occupational group). The real threats come from the intrusion of market forces into professional relationships, from incessant government interference in day-to-day medical practice, from the bureaucratic imposition of forms of third-party regulation that create a great burden for practitioners but provide no benefit to patients.

Source

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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.

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Is excess regulation to blame for soaring pharmaceutical prices? "But don't regulations protect Americans from unsafe drugs? 'These particular regulations, the 1962 amendments, have proven to be more deadly than all of the drug toxicity that occurred before their passage,' Dr. Ruwart claims. She estimates that between 1963 and 1999, 4.7 million people died prematurely while the medicine which could have saved them languished in mandated testing. 'The amendments saved a few thousand lives, but the cost was letting millions die waiting for treatment. That's why the amendments are 'excess' regulation,' Dr. Ruwart explains."





A CARING PUBLIC HOSPITAL SYSTEM

In Australia. No wonder Australia also has a large private medicine system.

Elective surgery was suspended yesterday for six weeks at Royal North Shore Hospital, the first NSW public hospital to cease all but emergency operations during an extended holiday shutdown. In the next fortnight, other hospitals are expected to stop elective surgery for periods of up to six weeks, leaving the 70,000 people due for operations - thousands of whom have been waiting longer than a year - with nowhere to go.

A panel of senior surgeons appointed by the Government to examine the surgical crisis is due to present its recommendations to fellow doctors and the Health Minister, Morris Iemma, today. The Government has defended the Christmas shutdown, but critics say it is getting longer each year as hospital administrators use the cancellation of elective surgery to control budget blowouts. The chairwoman of the hospital practice committee at the Australian Medical Association (NSW), Elizabeth Feeney, said that, historically, the holiday closure was limited to one or two weeks. "It is not only the Christmas shutdown; there are closures throughout the year that are less obvious," Dr Feeney said. "They still have to cover the out-of-hours and emergency operations. So, quite clearly, there are surgeons and anaesthetists around who could be doing elective surgery during this period.".....

The Australian Society of Orthopaedic Surgeons' national co-ordinator, Stephen Milgate, said his members had offered to double the number of operations they performed with the existing workforce if the hospitals would open more theatres and beds. "Regardless of how they try and reorganise the deckchairs on the Titanic, there is a massive shortage of operating time for elective surgery in NSW public hospitals."

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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.

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YOUR BUREAUCRATS WILL PROTECT YOU

A murderous doctor got away with it because the watchers were on his side.

THE GMC should be stripped of its right to hear disciplinary cases against doctors, the Shipman Inquiry urged yesterday. The statutory body which regulates the medical profession has been all too ready to look after its own at the expense of patients, Dame Janet Smith, the inquiry chairman, concluded.

She had built a picture of the General Medical Council which "tends to favour the interests of doctors". Where there is a conflict between patient and doctor, she said the GMC "does what the profession thinks is right". She called for the culture of self -interest that continues to pervade the GMC, long after Harold Shipman has gone, to be swept away. "Having examined the evidence, I have been driven to the conclusion that the GMC has not, in the past, succeeded in its primary purpose of protecting patients," she said. "Instead it has, to a very significant degree, acted in the interests of doctors."

Dame Janet concluded that some in the GMC will find the report, and more than 100 recommendations, a "bruising" experience. There will be an inevitable period of upheaval within the GMC but insisted that the resulting "greater openness" will help repair the relationship of trust and confidence between doctor and patient.

Sir Graeme Catto, president of the GMC, insisted, despite Dame Janet's criticism, that it was not appropriate for him to resign. He said: "We need to learn from the lessons of the past. Perhaps we were once like an old boys' club but that is absolutely not the case now. "That culture has changed very considerably. These things do not happen overnight, they take time, and I think she gives us great credit for the changes that have already taken place. We are making every effort to make our own procedures accessible, streamlined and transparent, but we have long called for a single portal that could be the confidential first port of call for people with concerns."

John Reid, the Health Secretary, said that Dame Janet had made some "very significant recommendations that would have a major impact on service delivery". He said: "She had made significant recommendations concerning the constitution and operation of the GMC. We have recently made changes to the constitution of the GMC to ensure a far greater voice for patient intersts. "We will consider carefully the recommendations Dame Janet makes for further reform, and the implications of her recommendations for other regulatory bodies."

Relatives of Shipman's victims immediately called on the Government to bring about "much needed reform" in the systems in place to monitor, report and police medical practitioners. Ann Alexander, the solicitor who represents more than 200 of the victims' families, said: "It has taken a series of tragic cases for the GMC to begin to look at the way it polices the medical profession. But for many it is too late. A radical rethink of the system is required on how best to regulate the medical profession in the future. "The GMC has introduced a series of reforms aimed at restoring public confidence but for many these fall woefully short of what they need to do. Many people who wish to complain about a member of the medical profession simply do not know how to go about it. When they do find out the procedures, they are cumbersome, lengthy and off-putting."

Kathleeen Wood, whose 83-year-old mother Bessie Baddeley was murdered by Shipman in November 1997, blamed the medical profession for looking after their own. She said: "The GMC were probably looking after each other. That was the way things were then. I am sure the GMC will pay attention to these comments because they would be mad not to." Barry Swann, 54, whose 79-year-old mother died at the hands of Shipman, called for an overhaul of the medical monitoring system. He said: "It comes as no surprise Dame Janet says the GMC protected their own. I knew that in 1997 when my mother died. The doctors cannot be trusted to govern themselves. We need a completely independent group to look out for the best interests of patients. "Doctors are in an incredibly privileged position. If we cannot trust the group that ensures they are spotless, then what faith are people going to have in the medical profession?"

Source

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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.

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Are Drug Price Controls Good for Your Health?

Now that the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003 provides senior citizens with drug insurance coverage beginning in 2006, several political and special-interest groups have expressed the opinion that the Medicare program should use its immense bargaining power to negotiate prices directly with drug manufacturers. While the MMA, as enacted, forbids such direct negotiation, a modification allowing direct Medicare negotiation is now under consideration. Specifically, proponents such as the American Medical Association and the AARP want the government to reduce drug prices paid by Medicare to those purchased by the Department of Veterans Affairs in the U.S. or set by the Patented Medicines Price Review Board in Canada.

New drugs generate immense social benefits by saving, improving, and extending lives. Economic theory is clear in its prediction that price controls will reduce biotechnology and pharmaceutical research and development (R&D) by lowering expected revenues and through reduced cash flows.

By 2006, the federal government will be purchasing or paying for nearly 60 percent of all prescription drugs in the United States, making it the most important buyer of medicines in America. Hence, we might assume that federal price controls will reduce incentives to invest in new drug development. To determine how direct Medicare negotiation and formulary restrictions might affect pharmaceutical and biotechnology R&D, in this study we examine how government influence has historically affected pharmaceutical prices. Based upon this evidence from the past, we can infer, rather than speculate about, the impact of what happens to pharmaceutical and biotechnology prices and R&D in the future as government exerts more control over prices.

Collecting national data for the U.S. for 1960-2001 and using multiple regression analysis, we find that from 1992 to 2001 a 10 percent increase in the growth of government's share of total spending on pharmaceuticals was associated with a 6.7 percent annual reduction in the growth of pharmaceutical prices. Two new laws, OBRA of 1990 and the Veterans Act of 1992, aimed at controlling drug prices under public programs, account for much of this impact.

Using these regression results, we then simulate how the prices for medicines would have differed throughout the period from 1960 to 2001 in the absence of any government influence. The simulation implied that the ratio of the pharmaceutical price index to the general price index would have been 1.27 rather than 0.94 in 2001, suggesting that pharmaceutical prices would have been about 35 percent higher, on average, in the absence of this government influence.

Using the predicted trend in pharmaceutical prices without government influence and an established elasticity of R&D spending with respect to drug prices from prior research, we determined that the resulting government-induced loss of capitalized pharmaceutical R&D expenditures was $188 billion (in 2000 dollars) from 1960 to 2001. This "lost" R&D may be translated into human life years "lost"-literally, increased pain and suffering and shorter lives caused by the absence of new medicines and future research-by using results from recent econometric work on the productivity of pharmaceutical R&D in the U.S. over the same period. We conclude that the federal government's influence on real drug prices cost the U.S. economy approximately 140 million life years between 1960 and 2001.

Applying this same analysis to the future, we predict that the increased government influence on drug purchases under the MMA will dramatically reduce both real drug prices and R&D spending. We estimate that real drug prices will decline by 67.5 percent (or about 49 percent lower than pre-MMA levels) if purchases under the MMA are treated in the same manner as drug purchases under Medicaid and the VA have been treated historically. We further estimate that this decline will reduce R&D spending by 39.4 percent, or $372 billion over the lifetime of the act. This translates into a reduction of 277 million life years.

With the passing of the MMA, an additional 14 percent of the population and, more important, an additional 40 percent of all drug consumption, will fall under government's purview. Many wish to replace the noninterference clause presently contained in the MMA with some type of direct government price setting mechanism. The results of this study indicate that government's downward pressure on drug prices has historically generated sizable social costs during a forty-year period when only a relatively small percentage of pharmaceutical expenditures were directly controlled by the government.

This suggests that imposing price controls similar to those found in the VA, Canada, or Medicaid for 60 percent of all biotechnology and pharmaceutical use will reduce investment in R&D and lead to a loss of life and life expectancy of a greater magnitude than has been the case for the past half-century for these types of price controls. Consequently, our findings suggest that informed public policy debate should consider the trade-off between lower drug prices now and future health benefits lost because of lower R&D spending.

Source

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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.

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Tort Reform Would be A Great New Year’s Resolution


By Nathan Tabor

The right to seek justice in a court of law is fundamental to our American way of life. If a person has been wronged, cheated, or hurt by the actions of another, whether intentionally or negligently, the injured party is entitled to just compensation. That’s only fair. So I hold a deep respect for the right of individuals to access our civil courts.

But like President Bush, I still believe that we must make reforming our system of civil litigation a top priority in 2005. We need common-sense reforms that will restrict frivolous lawsuits, abolish joint and several liability provisions, and limit outrageous punitive damage awards that are completely out of proportion to actual losses.

The number of civil lawsuits filed in our courts has tripled over the past 40 years. Often these lawsuits have no real merit but are used simply to extort cash payments from the person or business being targeted. (The Reverend Jesse Jackson is an expert at this kind of race-based extortion) And many times, even if the plaintiff is in the right, the “boxcar damages” awarded by juries are completely out of proportion to the actual harm suffered.

Interesting fact: almost half of the money won in malpractice lawsuits ends up in the pockets of the plaintiff’s attorneys. Maybe that’s why the American Trial Lawyers are so adamantly opposed to tort reform.

Often innocent businesses have to settle such lawsuits even when they are in the right. Unfortunately, this whole process costs us jobs. When a business is forced to spend hundreds of thousands of dollars defending against frivolous lawsuits, it has less money to expand its operations, invest in research or hire more employees.

This whole corrupt practice isn’t about evil corporations and their hapless victims who need legal protection. It is nothing more than legalized larceny, and it needs to be stopped!

Nowhere is this truer than in the medical profession. The rapidly escalating cost of liability insurance has reached unaffordable levels for an increasing number of medical practices. Some doctors have to pay as much as 50 percent of their gross income for malpractice insurance. Yet in our litigious society they can’t afford to be without it. Many OB-GYN’s today find themselves forced to cease delivering babies altogether.

Personal story: My wife and I have a baby due in January. However, because of rising malpractice insurance our midwife can no longer deliver our baby.

Every day, the cost of health care in America increases because physicians feel compelled to practice “defensive medicine,” often prescribing unnecessary but expensive tests, operations or medicines, rather than risk a lawsuit.

North Carolina’s Senator John Edwards campaigned for Vice President on the theme that he came from a poor working family but pulled himself up by his own bootstraps to become a self-made millionaire. What hypocrisy.

We need to stop these frivolous lawsuits and put caps on disproportionate punitive damages. Or even better yet, move to the English model. There, if you sue somebody and lose, you pay the legal fees for the other side. This might be a simple solution to a complicated problem.

One thing for sure, tort reform would be a great gift for the American people!



(Nathan Tabor is a conservative political activist based in Kernersville, North Carolina. He has his BA in Psychology and his Master’s Degree in Public Policy. He is a contributing editor at www.theconservativevoice.com. Contact him at Nathan@nathantabor.com).





ANOTHER PUBLIC MEDICINE TRIUMPH

When we allow for the famous British "fudge", "acceptable" translates as "woeful"

Half the hospitals in England have only "acceptable" levels of cleanliness, assessments by the Department of Health show.

But only 24 were rated poor and three unacceptable, as the department issued instructions designed to make hospitals cleaner places. The new guidance gives instructions on how often different areas of the hospital should be cleaned. Very high-risk areas, such as intensive care units, should have floors cleaned twice a day with a wet mop, be machine cleaned once a week and stripped and resealed once a year. Low-risk areas, such as corridors, need a full clean only once a week and a machine clean once a quarter.

The fact that the department should feel the need to tell hospitals how to keep their premises clean indicates some lack of confidence in local management, despite repeated promises to decentralise control. The latest inspections found that 10 per cent of hospitals (118) were "excellent", 456 "good", 583 "acceptable", 24 "poor" and 3 "unacceptable"....

Lord Warner, the Health Minister, said that there was no clear link between hospital cleanliness and rates of infection by the superbug MRSA, though it was not unreasonable for the public to make such a link. "If a hospital is well cleaned, it is more likely that it will have low infection rates. But you could still get an infection in a spotless hospital," he said. He said that the rise of MRSA had stalled in the past few years, coinciding with the department making mandatory the collection of figures on MRSA bloodstream infections. But hospital infections continue to rise. All that has stopped increasing is the proportion of infections caused by MRSA, which have stuck at about 40 per cent of the total...

["Collection of figures" prevents disease? Colour me skeptical!]

Paul Burstow, the Liberal Democrat health spokesman, said: "Government targets hamper the effort against infection. Patients are shunted from ward to ward and there is not enough time to clean beds properly between patients. "Infection-control staff are often ignored and the spread of infections continues. "Ministers' promises to fly in experts from overseas is an insult to experts in this country. We have infection-control nurses and doctors who know what needs to be done. The problem is that they are not being listened to." ...

Hospital-acquired infections, including MRSA, are blamed for 5,000 deaths a year. But campaigners claim that the true toll could be more than twice this figure.

More here

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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.

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

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HUGE WASTE IN BRITAIN'S "NATIONAL HEALTH"

The National Health Service will cost the country 20 billion pounds more than it should by 2010 because of the Government's failure to implement cost- effective reforms, an authoritative report has concluded. If reform had been put ahead of increased funding, the same NHS services could have been delivered for 90 billion pounds a year, instead of the 110 billion pounds they are actually likely to cost by 2010-11, the study found. Nick Bosanquet, Professor of Health Policy at Imperial College London and author of the report published by the think-tank Reform, concluded that the NHS is improving and delivering better services - but that the improvements have been bought at a huge and unnecessary cost.

By 2010 Britain will have the most expensive healthcare system in the world - excluding the US - absorbing nearly 11 per cent of GDP. The same results could be delivered for 9 per cent of GDP, which has proved perfectly adequate for other comparable countries. "International evidence shows that reform can be a pretty powerful way of getting more output from existing capacity," Professor Bosanquet said. "If we had had limited extra funds, plus reforms in the way the system works, we could have had a superb NHS for 9 per cent of GDP. "Instead, we shall be spending 10.5 to 11 per cent of GDP - an extra 20 billion pounds. That would be enough to fund the entire social housing programme."

His paper, The NHS in 2010, is complimentary about much that has been achieved in the NHS in recent years, but it will be seen as a direct challenge to Government claims that the additional funds poured in by the Chancellor - 40 billion pounds over the five years from 2002-03 - were needed to turn the service around.

On Friday the chief executive of the NHS, Sir Nigel Crisp, said the NHS was making "fantastic progress" in reducing waiting times. Professor Bosanquet does not demur, but says that this is the result of reforms, not cash. "The failure to use reform earlier means that waiting time targets will be reached much later and at much greater cost," he said. "The six-month waiting time target could have been reached in 2004 instead of 2005 and the three-month target in 2006 instead of 2008; earlier results which would have benefited thousands of patients." This could have been done, he argues, if greater incentives for the core health service had been introduced along with the new treatment centres and the use of the private sector, which had not even been mentioned in the 2000 NHS Plan.

According to the report, the core of the problem is that the NHS has taken on huge extra costs, which by 2010 will be very hard to fund. Private Finance Initiative (PFI) schemes, extra staffing, the new GP contract and the Treatment and Diagnostic Centres will soak up funds that will also be needed for drugs recommended by Nice, implementation of National Service Frameworks (treatment guidelines) and other new therapies.

The share of the GDP spent on the NHS by 2010 will be "well above" the European average and more than 50 per cent higher than in Scandinavia and New Zealand. "On a worldwide basis the public sector share of spending is likely to be the highest of any system," Professor Bosanquet says.

He has a long track record of healthcare analysis. He is an expert in the productivity of health services, and has advised the Health Select Committee, the World Health Organisation, the World Bank and the National Audit Office. The Government will find it hard to dismiss his views as those of a "Conservative Front Organisation", as they did of an earlier intitiative by Reform advocating a different system for funding the NHS. He makes it clear that he is committed to the NHS and supports many of the Government's initiatives, but, he concludes, "in terms of the UK's longer-term social and economic challenges, the level of spending project for 2010 represents poor value for money ".

As an example to show how reform succeded where extra funding failed, he cites waiting time targets. By 2002 it was evident that targets for heart operations would be missed and the choice programme was introduced, first in London and later nationally. This provided incentives for better use of current capacity and waiting times quickly shortened - to the extent that the London Heart Hospital, bought by the NHS to provide extra capacity, has never managed to fill its beds.

"Greater competition also reduced waiting times for cataract treatments and hip replacements" he says. "Reform succeeded where funding had failed." Another example is in A&E departments, which have been given only an extra 30 million pounds a year, yet have greatly improved waiting times by changing working practices.

Nigel Edwards, policy director of the NHS Confederation, said that the speed with which the Government had made changes to the NHS meant that some schemes would not be implemented in the most cost-effective form.

Source

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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.

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

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THE WORST PUBLIC HOSPITAL IN L.A. IS OVER-FUNDED

For years it has been a heartfelt cry: "This hospital desperately needs more money!" Whenever Martin Luther King Jr./Drew Medical Center is criticized, as it often is, the response from supporters is the same. They say Los Angeles County leaders never wanted King/Drew built in the first place — and have been trying to starve it ever since.

The numbers, however, tell a different story. Though widely believed, the notion that King/Drew is being shortchanged is false. The medical center spent more per patient than 75% of the public and teaching hospitals in California, according to a 2002 state audit that looked at fiscal year 2000. The difference is stark when King/Drew is measured against the three other general hospitals run by Los Angeles County. It spent $492 more per patient daily than Olive View-UCLA Medical Center, $685 more than County-USC and $815 more than Harbor-UCLA in 2002-03, county figures show.

The hospital with the most comparable budget is Harbor-UCLA, a much bigger facility 10 miles away. Last year, Harbor-UCLA had nearly $372 million to work with, not much more than King/Drew's $342 million. Harbor-UCLA, however, did far more with its money. It treated 61% more people in its emergency room and admitted 91% more patients. And it performed certain complex procedures, such as open heart surgery and kidney transplants, that King/Drew did not — drawing in patients who were sicker and more expensive to care for.

King/Drew's problem is not the amount of money it gets but the way the money is squandered, according to audits, financial records, legal filings and dozens of interviews. As at most hospitals, its greatest cost is employees. But King/Drew, with a staff of nearly 2,500, spends inordinate sums on people who do little or no work. The rest of the hospital — hardworking employees, patients and their families — often make do or do without.

Here are some examples:

* In the last five years, King/Drew has spent nearly $34 million on employee injuries — 53% more than Harbor-UCLA and more than any of the University of California medical centers, some of which are double or triple King/Drew's size. Employees make claims for such things as damage to their "psyche," assaults by their colleagues and a variety of freak accidents, according to a Times review of workers' compensation claims.

* Last year, King/Drew employees billed for 299,804 hours of overtime, costing the hospital nearly $9.9 million. That's 61% more than the sum spent by Harbor-UCLA, which has about 400 more workers. Fourteen King/Drew employees pulled in more than $50,000 each in overtime. At Harbor-UCLA, there was one.

* Some employees habitually fail to show up, logging weeks, even months, of unexcused absences each year. And those who do come to work often don't do their jobs, causing one consultant in 2002 to remark that they had "retired in place." Others are distracted or impaired. County Civil Service Commission filings tell of staff members grabbing and clawing each other's necks; inspection reports tell of patients literally dying of neglect.

* King/Drew pays its ranking doctors lavishly. Some draw twice what their counterparts make at other public hospitals — often for doing less. Eighteen King/Drew physicians earned more than $250,000 in the last fiscal year, including their academic stipends. Harbor-UCLA had nine.

If King/Drew and county health officials had controlled this excess spending, the hospital could have used the money in other areas, or even put it back into county coffers.

The mismanagement of the hospital is no secret. The county Board of Supervisors and the Department of Health Services it oversees have received decades of warnings. Since 2000, there have been dozens of audits, scores of disciplinary reports and hundreds of workers' compensation claims. Yet even as the county has faced enormous pressures over the years to trim its health budget, the board has largely spared King/Drew. The slightest suspicion that a cut might be coming mobilizes activists who treasure the black-run hospital. So the waste continues.....

On Friday morning, Aug. 13, 2004, patients filed into King/Drew's orthopedic clinic seeking treatment for their broken bones and aching joints. Help was not to be had. The medical staff — doctors, doctor trainees and physician assistants — was inexplicably absent. It took three hours or more to find fill-in doctors, county auditors later found. That Friday the 13th was merely the beginning of a bad weekend for King/Drew. Later that day, officials were forced to close the emergency room to ambulances until Monday morning because nearly half the nurses on some shifts had either called in sick or failed to show up.

Every hospital must contend with the national nursing shortage — and King/Drew's shortfall, given the county's relatively low pay and its ongoing problems, may be worse than most. More than 35% of its nursing positions are vacant. But the hospital also is thrown into chaos when nurses, doctors and others on the payroll simply don't come to work......

Another cost, less easily tallied, results from employees who show up but don't do their jobs. A nursing supervisor found nurse Nopawan Mahasuwan "asleep in a lounge chair, mouth open, snoring and drooling," in February 2000, according to an internal hospital memo. Supervisor Liberty Pascual said she watched Mahasuwan sleep for at least three minutes before trying to wake her. Mahasuwan, however, said she was watching a monitor — not sleeping. And, she added, Pascual didn't simply nudge her, but delivered a smack that caused pain and swelling, according to the memo......

Dr. George Locke is a member of King/Drew's ruling class. When he pulls his 2002 Mercedes-Benz coupe into his reserved spot at the hospital, he routinely stands beside it until a female assistant arrives to carry some of his belongings inside. On his way out, someone is on hand to tote them back. When political leaders, such as Rep. Maxine Waters (D-Los Angeles), arrive at King/Drew, Locke often is there to greet them with a hug. As neurosciences chief, Locke made a total of more than $1 million over the last two fiscal years. That includes his hospital salary and a stipend he receives from King/Drew's affiliated medical school, records show. Top county officials can't say what Locke does for all the money he earns......

More here

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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.

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

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