A Different 'Right to Life' -- one being denied

Today the Supreme Court will consider a petition to hear a case raising profound issues regarding the right of individuals to make their own health-care decisions. The case is Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach. The suit claims that FDA violates the due process rights of terminally-ill patients, who have exhausted all approved options and are unable to enter a clinical trial, by prohibiting access to promising investigational drugs.

Consider the plight of such patients. They search for clinical trials of new drugs that might extend their lives. Nearly all are ineligible. Of the few who do qualify, many learn the trial is fully enrolled and closed, or too far away. Others face a 50-50 chance of getting a placebo (a sugar pill) under blinded conditions (meaning neither they nor their doctors know what they are getting). Many are allowed to die without being told about or offered the active drug.

The FDA commonly insists on statistically comparing the timing and severity of the deaths of untreated (placebo) patients with those of patients who receive the potentially effective drug. This renders the FDA's vaunted "science" for drugs intended to treat terminal illnesses little more than a crude measurement of the height and accrual rate of two piles of bodies. There are better, less ethically challenged trial methods available to test drugs, but the FDA has consistently refused to accept them.

The FDA has ignored our Citizen's Petition for more than four and a half years. This petition is the FDA's administrative mechanism for public challenges of its decisions and policies. It is little more than a cruel joke for the sick. The agency is required to respond to a petition within six months but rarely does, and often never responds at all. One's only recourse is to sue and then fight the inevitable FDA motion for dismissal claiming the plaintiff hasn't exhausted all administrative options -- meaning the FDA hasn't yet acted on the Citizen's Petition.

If the suit survives, the plaintiffs find that lower courts have so rarely allowed a patient to challenge an FDA decision or policy that they have no legal basis to get to trial -- as was recently learned by a group of cancer patients challenging the FDA's mishandling of a new therapeutic vaccine called Provenge for terminal prostate cancer. The federal judge in that case dismissed all parts of the suit directed at FDA's decision to delay the drug for years because patients had no "right" to challenge a decision the FDA claimed was not yet "final." The judge's decision will be lethally final for thousands of men with prostate cancer.

No terminal patient has the time needed to wrestle with the FDA in court if they first have to establish a right to do so. Consider that the Abigail Alliance case was filed in 2003. Over the ensuing years, it has carried the names of three defendants, tracking the musical-chairs nature of the highly-politicized job of FDA commissioner. At every turn the FDA stalled, then claimed we had lost our standing because the patients named in the original suit had died. The appeals court didn't buy that cruel argument, but it took months to resolve. During this slow dance choreographed by the FDA, more than 2.4 million Americans have died from cancer alone.

The majority opinion of the appeals court suggested that this is an issue for Congress to solve. A great idea if one has a full lifetime to work on it. In the last session, a bill called the Access Act designed to fix some of the problems was introduced in Congress with multiple sponsors, but any significant reform takes years to enact. The stopgap FDA reform bill passed last year contained none of the Access Act provisions, addressing only the more politically expedient and high-profile issues swirling around FDA's handling of drug safety. The omission was in part the result of the difficulty faced by terminal patients when they try to get the attention of Congress. They simply don't live long enough to connect and organize into a political force.

No matter one's judicial philosophy, it is inconceivable that the framers of the U.S. Constitution intended unelected, tenured career bureaucrats to hold absolute power over American lives without prospect of challenge in the courts. The framers understood that the pursuit of life is an inalienable right that should not be abridged without due process of law. The FDA and a majority of the D.C. Circuit Court of Appeals think terminally-ill Americans are excluded from the fundamental right to pursue life. The Supreme Court now has the opportunity to take this case and correct those egregious misjudgments.

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British dentistry meltdown

The crisis in NHS dentistry is rapidly worsening because dentists are switching thousands of patients to private treatment, figures show. NHS treatment is in free fall with a 16 per cent collapse in the proportion of dentist's earnings made from the NHS from the years 1999-2000 to 2005-06. The figures, published by the NHS Information Centre, highlight the challenge facing the NHS after a survey, disclosed in The Independent yesterday, revealed that dentistry in England was the most expensive in Europe. The fall in NHS earnings has accelerated in the past two years and is most pronounced among young dentists who are the future of the profession.

NHS incomes fell by over 20 per cent in a single year from 2004-05 to 2005-06, as a proportion of total earnings, among dentists aged under 35. Young dentists now earn on average only just over a third of their income (36 per cent) from the NHS.

Patients' organisations said the decline in NHS dentistry was alarming and could lead to the eventual collapse of the NHS dental service. Surveys show patients are having increasing difficulty in finding an NHS dentist and the Government admitted last year that two million patients who wanted access to an NHS dentist had failed to get it. Anthony Halperin, chairman of the Patients Association and a practising dentist in London, said: "There is no question that dentists are switching patients to private treatment where they can because they feel it is the long-term future for them. They don't want to do run of the mill work, they want to do quality work and that is very difficult under the NHS."

The NHS Information Centre's report into dentists' pay showed that dentists in multi-partner practices who own their surgeries earned 114,000 pounds on average in 2005-6 from NHS and private work. Single-handed practitioners with their own practices earned 94,000. Dentists earned 58.2 per cent of their income from the NHS in 1999-2000 but that fell to 41.9 per cent in 2005-06. Among those under 35, the proportion of earnings from the NHS fell from 63.8 per cent to 36 per cent in the same period, a decline of more than a quarter in six years.

Dr Halperin said the new dental contract introduced in April 2006 had made matters worse. The contract replaced the fee-for-item payment system with three payment bands to encourage a preventive approach. "Dentists are really unhappy about the new contract. They are worried they are going to be asked to do more work for less money. If the contract turns out to be uneconomic, they will switch more patients to private work because it is a safer option and if that happens it will lead to the collapse of NHS dentistry."

The British Dental Association said the decline in NHS incomes reflected a wider malaise in the profession. Peter Ward, chief executive, said: "The dental workforce as a whole is looking to a future in which they feel less and less able to rely on the NHS and are adjusting the balance of their work accordingly." Implementation of the new contract had resulted in up to 1,000 dentists leaving the NHS and 266,000 fewer patients accessing NHS dentistry, the association said. Mr Ward said: "These statistics offer further evidence that the Government's reforms to NHS dentistry aren't achieving their stated aims. This contract has failed to improve access for patients and failed to allow dentists to deliver the kind of modern, preventive care they believe their patients deserve."

The Department of Health rejected suggestions that NHS dentistry was in decline. A spokesman said: "It would be wrong to take this shift in the share of income as evidence that dentists are turning their backs on the NHS. It simply reflects the ever-increasing demand for purely cosmetic dental work which, quite rightly, is not provided on the NHS." He added: "Access to dentistry has remained broadly stable in the past two years and we are doing all we can to make further improvements."

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