Wednesday, June 24, 2009

Is Government Health Care Constitutional?

The right to privacy conflicts with rationing and regulation

Is a government-dominated health-care system unconstitutional? A strong case can be made for that proposition, based on the same "right to privacy" that underlies such landmark Supreme Court decisions as Roe v. Wade.

The details of this year's health-care reform bill are still being hammered out. But the end result is sure to be byzantine in complexity. Washington will have immense say over how, when and through whom Americans are treated. Moreover, despite the administration's public pronouncements about painless cuts in wasteful spending, only the most credulous believe that some form of government-directed health-care rationing can be avoided as a means of controlling costs.

The Supreme Court created the right to privacy in the 1960s and used it to strike down a series of state and federal regulations of personal (mostly sexual) conduct. This line of cases began with Griswold v. Connecticut in 1965 (involving marital birth control), and includes the 1973 Roe v. Wade decision legalizing abortion.

The court's underlying rationale was not abortion-specific. Rather, the justices posited a constitutionally mandated zone of personal privacy that must remain free of government regulation, except in the most exceptional circumstances. As the court explained in Planned Parenthood v. Casey (1992), "these matters, involving the most intimate and personal choices a person may make in a lifetime, choices central to personal dignity and autonomy, are central to the liberty protected by the Fourteenth Amendment. At the heart of liberty is the right to define one's own concept of existence, of meaning, of the universe, and the mystery of human life."

It is, of course, difficult to imagine choices more "central to personal dignity and autonomy" than measures to be taken for the prevention and treatment of disease -- measures that may be essential to preserve or extend life itself. Indeed, when the overwhelming moral issues that surround the abortion question are stripped away, what is left is a medical procedure determined to be "necessary" by an expectant mother and her physician.

If the government cannot proscribe -- or even "unduly burden," to use another of the Supreme Court's analytical frameworks -- access to abortion, how can it proscribe access to other medical procedures, including transplants, corrective or restorative surgeries, chemotherapy treatments, or a myriad of other health services that individuals may need or desire?

This type of "burden" analysis will be especially problematic for a national health system because, in the health area, proper care often depends upon an individual's unique physical and even genetic history and characteristics. One size clearly does not fit all, but that is the very essence of governmental regulation -- to impose a regularity (if not uniformity) in the application of governmental power and the dispersal of its largess. Taking key decisions away from patient and physician, or otherwise limiting their available choices, will render any new system constitutionally vulnerable.

It is true, of course, that forms of rationing already exist in our current system. No one who has experienced the marked reluctance to treat aggressively lethal illnesses in the elderly can doubt that. However, what may be permissible for private actors -- including doctors and insurance companies -- is not necessarily lawful when done by the government.

Obviously, the government does not have to pay for any and all services individual citizens may desire. And simply refusing to approve a procedure or treatment under applicable reimbursement rules, as under the government-run Medicare and Medicaid, does not make the system unconstitutional. But if over time, as many critics fear, a "public option" health insurance plan turns into what amounts to a single-payer system, the constitutional issues regarding treatment and reimbursement decisions will be manifold.

The same will be true of a quasi-private system where the government claims a large role in defining acceptable health-insurance coverage and treatments. There will be all sorts of "undue burdens" on the rights of patients to receive the care they may want. Then the litigation will begin.

Anyone who imagines that Congress can simply avoid the constitutional issues -- and lawsuits -- by withdrawing federal court jurisdiction over the new health system must think again. A brief review of the Supreme Court's recent war-on-terror decisions, brought by or on behalf of detained enemy combatants, will disabuse that notion. This area of governmental authority was once nearly immune from judicial intervention. Over the past five years, however, the Supreme Court (supposedly the nonpolitical branch) has unapologetically transformed itself into a full-fledged, policy-making partner with the president and Congress.

In the process, the justices blew past specific congressional efforts to limit their jurisdiction and involvement like a hot rod in the desert. Questions of basic constitutionality (however the court may define them) cannot now be shielded from judicial review.

It is, of course, impossible to predict how and when the courts will ultimately rule on the new health system. Much depends on the details and the extent to which reasonable and practical private alternatives to the national plan remain. In crafting the law, however, its White House and congressional sponsors must keep privacy -- that near absolute right to personal autonomy they have so often praised and promoted -- squarely before them. The only thing that is certain today is that the courts, and not Congress, will have the last word.


NHS still going around in circles over dentistry

NHS dentists should be paid according to the number of patients on their list and penalised for shoddy operations that require repeat visits, an independent review has recommended. The proposals, which have been accepted in principle by the Government, include changes to improve access to NHS dentists and to end the “drill-and-fill” culture of operations. The review said that dentistry had become too preoccupied with treatment rather than prevention over the past 60 years.

The recommendations include rewarding dentists for registering new patients and building up relationships with existing ones, similar to those between GPs and their patients. Jimmy Steele, the lead author from Newcastle University, said that dentists’ responsibilities must be as much about ensuring that people understand oral health and diet as carrying out fillings.

A series of pilot trials will start in the autumn. Income will be determined on patient list size, quality of care and the number of courses of treatment.

The plans for patient registration have marked the return of a policy scrapped by Labour in its much-criticised dental reforms of 2006 — and which the Government said at the time would end the “drill-and-fill” culture. Figures show that around a million fewer people now have access to an NHS dentist in England than before the contract came into force three years ago. Andy Burnham, the Health Secretary, said yesterday that he recognised that dentistry was “an area of unfinished business”. He accepted that the contract had been problematic and that some decisions could have been taken differently.

Professor Steele said that dentists would have as much as 50 per cent of their income linked to the number of patients on their books. “It’s an incentive to take more patients on,” he said.

The review also recommends that dentists have greater accountability. This could mean being penalised for faulty work and having to carry out repairs at no extra charge to the NHS. At present, dentists can charge local health trusts for a procedure and then charge again even if they are the reason why a patient has had to return for further treatment. Under the new plans, the points dentists receive for carrying out an operation would not be awarded a second time if restorative work had to be carried out within three years.

Professor Steele said: “It’s a basic principle of quality and warranty. If I think the filling that I’m about to put in, or the crown I’m about to prepare for, is not going to last three years, then I shouldn’t be picking up that handpiece.”

Other plans include a new system of patient charges, replacing the current three-band system with one of between five and 12 bands. This was in response to the view of some patients that they did not always receive value for money.

Professor Steele said that patients should be called in for check-ups based on their individual need between every three and 24 months. “The six-month recall has no basis in science,” he said. “It’s just got a long history.”

The review also calls for more focus on preventative healthcare, with the aim of teaching people how to better look after their teeth. Mr Burnham said this could include looking at people’s diet. He has long been in favour of adding fluoride to the water in deprived areas.

The 2006 contract, which was supposed to allow dentists to spend more time with their patients, was criticised by dentists, while they were accused of playing the system. Yesterday’s report included examples of dentists recalling patients too often, or choosing more profitable treatments for patients when a less lucrative alternative was available.

Professor Steele added: “In the last 60 years, dental services have all been about quantity. We need to make a jump — and it’s a difficult jump — to move on to quality, to accept that less is usually actually better.”

Norman Lamb, the Liberal Democrat health spokesman, said the “near-destruction of NHS dentistry will be one of Labour’s most shameful legacies”. He added: “The Government has repeatedly botched efforts to reform dentistry services in this country. The NHS must learn from past mistakes and ensure that future reforms are rigorously piloted. It is also vital that the concerns of dentists and patients are listened to.”

Andrew Lansley, the Conservatives’ health spokesman, said that the review confirmed the comprehensive failure of the 2006 reforms. “It is bad news for the Government that their own independent reviewer has highlighted a string of problems with NHS dentistry and recommended moving to a patient registration systemas Conservatives have proposed.”

John Milne, of the British Dental Association, said: “What is important now is that the Government pilots properly the changes it makes and engages fully with the profession and patient groups as we move forward.”


FDA’s bad medicine

They are actually aiming to keep information about medical research away from doctors! Hard to believe but that's the sort of destruction you can expect when you put Leftists in charge. All decisions must be made by government bureaucrats -- even medical decisions, apparently

President Barack Obama promised to shake up the Food and Drug Administration, so it's no surprise that his new FDA leadership team has made bold moves. Deputy Commissioner Joshua Sharfstein, who led the agency until Commissioner Margaret Hamburg was approved by the Senate on May 18, announced his presence with authority. In his first two months, Sharfstein's FDA has threatened to regulate Cheerios as a drug because its label says it can help lower your cholesterol and proposed action against drug companies because Google Internet searches for their products don't show enough safety information.

Sharfstein was chosen to lead the FDA's drug enforcement efforts in part due to his connections as a former staff member for Rep. Henry Waxman (D-Cal.), chairman of the congressional committee that oversees the FDA, and one of the pharmaceutical industry's biggest critics. Since he's already shown a desire to clamp down on even minor infractions, drug makers and the medical community are holding their breath over what Sharfstein may do next. One likely move is a crack down on so-called "off label" prescribing of drugs, which has been one of Waxman's high priorities for years.

When the FDA approves new drugs or medical devices, they are approved to treat specific conditions in particular populations, which are identified on the products' labels. But once they are on the market, doctors are free to prescribe drugs and devices for any safe and effective use, including ones not indicated on the label.

Getting FDA approval to add another use to a drug's label is time consuming and very expensive, even after rigorous clinical testing shows the new use to be safe and effective. But physicians read medical journals. And if they find, for example, that a certain liver cancer drug is effective in treating kidney cancer, or that an antidepressant approved for adults also works for teenagers, these other uses tend to be adopted.

This practice of off-label prescribing is widespread, and is common in every field of medicine. By some estimates, as many as 60 percent of all prescriptions written are for off-label uses. The American Medical Association has repeatedly studied the practice and concluded that "physicians have the training and experience to determine what is the best or preferred method of treatment for their patients."

Accordingly, the AMA says off-label prescribing should often be considered "reasonable and necessary medical care, irrespective of labeling." Indeed, physicians may even be subject to malpractice liability if they do not use drugs and devices for off-label indications when doing so constitutes the medically recognized standard of care.

Still, certain members of Congress and bureaucrats in the FDA think doctors should prescribe nothing without the express consent of the federal government. The FDA, for example, proposed regulating off-label drug use in 1972, but gave this up after vigorous objection from the medical community. Beginning in the 1990s, however, FDA began restricting the ability of pharmaceutical manufacturers to give physicians peer-reviewed journal articles and other information about off-label uses of their drugs. FDA treats any drug information distributed by manufacturers, no matter what its form, as part of the product label. So as far as the agency is concerned, mailing out reprints of peer-reviewed journal articles describing an off-label use makes the drug or device "mis-branded."

Physicians try to keep abreast of new research findings, but they can't read every issue of the hundreds of medical journals published in this country. So drug makers have long distributed journal reprints in an effort to promote their products. Regulators regard the practice as grubby commercial marketing, but the distribution of scientific studies allows physicians to be better informed about new developments and enables them to make better treatment recommendations for their patients.

The practice also happens to be protected by the First Amendment. In a series of challenges to FDA's reprint restrictions, federal courts have held that the policies "restricted considerably more speech than necessary" to ensure the information was truthful and not misleading. FDA may monitor the practice to ensure the information is not biased, but forbidding the practice altogether is unconstitutional. By 2007, recognizing that the FDA could not ban the dissemination of all information about off-label drug uses, the agency published a guidance document in the waning days of the Bush Administration that explained what procedures drug firms had to follow in order to be within the boundaries of the law.

Rep. Waxman, however, chafed at even this modest step. He claimed the guidance would promote "potentially dangerous uses" of drugs and would "short-circuit the FDA review and approval process." Not only did Waxman criticize allegedly "abusive marketing practices" by the drug industry, he even attacked the integrity of medical journals themselves and the peer-review process, and he insisted that FDA bureaucrats be placed in the position of judging the quality of the scientific literature.

It's no wonder industry observers and the medical community suspect that Waxman's acolyte Joshua Sharfstein will soon turn his sights toward restricting this important and beneficial mechanism that inexpensively facilitates the dissemination of valuable information to physicians and their patients.

Opponents of off-label prescribing seem unable to balance the regulatory objective of protecting patients from unsafe drugs against the prerogative of physicians to use their best professional judgment to treat individual patients. They downplay the costs of FDA approval, exaggerate the credulity of physicians and their willingness to unquestioningly trust information distributed by drug manufacturers, and ignore the significant benefits off-label prescribing offers for patient care.

Physicians are reluctant to see FDA further restrict information about off-label uses. They know that the practice has large benefits and few costs. Its use should be extended, not curtailed by stricter regulation. Unfortunately, the FDA has a long, troubling history of succumbing to political pressure even when it harms the interests of doctors and their patients.


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