This conclusion is based on an analysis of Israel’s rejections of applications submitted by Gaza patients during 2009, which found a strong correlation between cases considered life-threatening and permit approval rates. It should be stressed that cases which are not defined as life-threatening, and which were denied by Israel, can still be clinically urgent: this includes, for example, conditions that can lead to the loss of limbs, organs, or eyesight.

The organizations argue that Israel must allow every patient requiring medical treatment that is unavailable in Gaza access to treatment outside the Strip without delay.

The policy, which was first adopted on June 2007, is still in effect today. In the past few weeks, PHR-IL has received about 40 applications from Gaza patients whose requests to exit Gaza to receive medical treatment had been rejected by the Israeli security authorities. This is an extraordinarily high number of rejections in a relatively short period of time, which calls for special attention, given that all of these patients suffer from non-life-threatening medical conditions. On June 15, 2010, after 11 individual requests submitted by PHR-IL to the Israeli security authorities had been rejected, PHR-IL submitted a collective request in behalf of the 28 remaining patients, asking the security authorities to reconsider their cases.

Distinguishing between a life-threatening medical state and one that hinders quality of life – while denying medical treatment in cases which are not life-threatening – contradicts the principles of medical ethics. These principles mandate that all patients are entitled to the best available medical treatment, regardless of the urgency of the treatment or the severity of their clinical state.

Such a policy also contradicts international humanitarian law and international human rights law, which uphold the rights to life, physical integrity and dignity. The right to medical treatment is integral to these rights, which are also recognized as fundamental rights under Israeli law.

Dr. Harel Arzi, Specialist in Orthopedic Surgery and PHR-IL volunteer: ‘The difference between causing individuals to suffer from defects on purpose and causing them to suffer from defects or disability by denying them medical treatment for an existing condition – this difference is merely semantic. Whoever prevents patients from accessing medical treatment by restricting their movement is directly responsible for their medical condition, even if he or she did not cause this condition.’

According to the organizations, the withholding of treatment from Gaza patients who do not fall within Israel’s delineated medical criteria is the result of considerations that are foreign to medicine, among which are political considerations. Furthermore, deliberately withholding medical treatment from patients in need in order to achieve political goals is a form of collective punishment, prohibited under international humanitarian law. It constitutes a further layer of Israel’s policy of tightening the closure of the Gaza Strip, imposing hardship on its residents and limiting their movement, and should be halted immediately.

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So how might the new Bioethics Commission operate? Fortunately, we have some idea because its new chair, Amy Gutmann, outlined her views on how bioethics commissions should be run in an article, “Deliberating About Bioethics” in the Hastings Center Report back in 1997. Most of the 13 member panel hasn’t been appointed yet, but Gutmann is well-known for her scholarly work on deliberative democracy, which she defines “as a form of government in which free and equal citizens (and their representatives), justify decisions in process in which they give one another reasons that are mutually acceptable and generally accessible, with the aim of reaching conclusions that are binding in the present on all citizens but open to challenge in the future.”  

In her article (co-authored with political philosopher Dennis Thompson), Gutmann distinguishes deliberative democracy from proceduralism and constitutionalism. In proceduralism, once basic rules of the game have been hammered out, moral disagreements are resolved through political bargaining or by moving them out of politics into the private sphere. Constitutionalism tries to avoid moral disagreement by creating a sphere of protected rights that are shielded from ordinary politics.

In Gutmann’s conception, deliberative democracy is an ongoing, transparent, society-wide discussion of fundamental values. Deliberative democracy is supposed to serve four important social purposes by addressing four ineradicable sources of moral disagreement. She identifies the four sources of moral disagreement as arising from (1) the scarcity of resources; (2) limited generosity; (3) incompatible moral values; and (4) the incomplete understanding that characterizes almost all moral conflicts. The four social purposes that deliberative democracy is supposed to address are (1) the promotion of the legitimacy of collective decisions; (2) the encouragement of public-spirited perspectives on public issues; (3) the promotion of mutually respectful decisionmaking: and (4) the correction of inevitable collective action mistakes.

Gutmann offers some concrete examples of how she thinks deliberative democracy might work. Let’s take scarcity. She notes that far more people need organs than there are organs available for transplant. How do we decide who gets them? She suggests that “deliberation can help those who do not get what they want or even what they need come to accept the legitimacy of a collective decision.” As it happens in 1984, the U.S. Congress passed the National Organ Transplant Act which made organ sales illegal. Since then donated organs have been allocated by the United Network of Organ Sharing based on various medical criteria depending on the specific organ. Although some voices (including mine) have been arguing for compensating donors as a way to increase supplies, it is true that there has not been much public pressure to change the current system. However, one hopes that the deliberative process will someday correct this particular collective action mistake. On the other hand, we can expect a lot more bioethical deliberation if the U.S. adopts a more centralized and increasingly government-controlled health care system. In another article Gutmann favorably cites the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) as an example of how democratic deliberation works in making decisions about what medicines and treatments will be made available to patients in that country’s National Health Service.

The next issue is limited generosity. Gutmann acknowledges, “Deliberation will not turn self-centered individualists suddenly into public-spirited citizens.” She argues that members of bioethics commissions should not be chosen just to represent specific interest groups; that would simply result in old-fashioned interest group bargaining. Gutmann asserts that the number and diversity of voices on a bioethics commission is not necessarily the most important factor in making deliberation work. Instead bioethics commissioners “must come to the forum open to changing their own minds as well as to changing the minds of their opponents.” Bioethics commissioners will be more amenable to changing their minds on such limited questions as when is it appropriate to include minors in medical research rather than issues like abortion and assisted suicide.

Which brings us to Gutmann’s third source of moral disagreement—incompatible moral values. Here she recommends that bioethics commissions isolate irresolvable conflicts and focus on areas where agreement might be possible, e.g., minors in medical research. As an example of how deliberation can “economize” on moral disagreements, she cites the fetal tissue research guidelines issued in 1975 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission held extensive public hearings and consulted legal experts, scientists, ethicists, and philosophers before promulgating its regulations allowing fetal tissue research. Those regulations included the requirement that researchers seeking to harvest tissue not have any part in the timing, method, or procedures used to terminate a pregnancy; no inducements to terminate a pregnancy could be made; both parents must consent; and artificial life support for nonviable fetuses was prohibited. But this deliberative outcome did not hold. In 1988, arguing that the fetal tissue research could encourage abortion, the Reagan administration imposed and later the Bush administration maintained a federal funding moratorium on fetal tissue transplant research. The moratorium was lifted by President Bill Clinton in 1993.

The history of the bioethical deliberation over fetal tissue research might be seen as an example of Gutmann’s fourth purpose of deliberation, the correction of mistakes. In the fetal tissue case, later experts did argue that political appointees under Reagan and Bush were mistaken in their belief that federal funding of fetal tissue research would lead to more abortions. On the other hand, given that a National Institutes of Health advisory panel in 1988 recommended after considerable deliberation that the moratorium be lifted, one suspects that the encourages-more-abortions argument for banning federal funding was a stand-in for a deeper philosophical repugnance toward all abortion. In any case, the fetal tissue case and President Obama’s decision last year to overturn President George W. Bush’s limits on federal funding of human embryonic stem cell research shows that bioethics decisions in the U.S. are already provisional and open to challenge.

I generally agree with the proceduralists and constitutionalists. In order to keep the social peace and allow various visions of the human to flourish along side of one another, certain big questions about birth, death, and the meaning of life must be isolated from politics, making them private concerns to be protected from majoritarian tyranny. But for her part, Gutmann concludes hopefully, “By making democracy more deliberative, we stand a better chance of resolving some of our moral disagreements, and living with those that will inevitably persist, on terms that all can accept.” Given the current stark polarization that characterizes our national political institutions (if not public opinion), Gutmann, as head of the new Presidential Commission for the Study of Bioethical Issues, has her work cut out. Good luck to her.

Ronald Bailey is Reason’s science correspondent. His book Liberation Biology: The Scientific and Moral Case for the Biotech Revolution is available from Prometheus Books.

[Economist] MORE than a week after the earth convulsed beneath it, Haiti has still to plumb the depths of suffering and want. The numbers are still only more-or-less informed guesses, but their magnitude is grim: perhaps 200,000 killed, 250,000 more injured and some 3m in desperate need of help. The generosity of the world’s response has also been profound. Barack Obama led the way, dispatching 16,000 American troops and marines, but others, from Europe to Brazil, Cuba, China and Israel, responded too. Immediate promises of aid added up to around nearly $1 billion.

The urgent task is to connect this supply of help with the demand. That is proving extraordinarily hard (see article). Seven days after the earthquake, the United Nations had got food to only 200,000 people. Lessons from other disasters are not always relevant to Haiti. The Asian tsunami, for example, struck a ribbon of remote, mainly rural, areas. The governments of the affected nations could lead the relief effort. But Haiti’s institutions were weak even before the disaster. Because the quake devastated the capital, both the government and the UN, which has been trying to build a state in Haiti since 2004, were decapitated, losing buildings and essential staff. So did many NGOs. The president, René Préval, and his cabinet have been reduced to meeting in a police station.

Into that vacuum stepped the United States. Inevitably the dispatch of marines, Black Hawks and an aircraft-carrier looked to some like an invasion (after all, they have been there before). A brief caricature of great-power prickliness ensued as the Americans took charge of the airport and seemed to some others to give priority to their own flights. But by mid-week the airport was receiving three times as many flights as it did before the earthquake. The American forces are well-equipped for the vital task of setting up a supply chain for aid. That is what they are doing under a sensible division of labour eventually hammered out (the Brazilian-led UN peacekeeping force remains in charge of security, and the UN will co-ordinate the aid effort). Certainly most ordinary Haitians seemed pleased to see the Americans.

They are just desperate for water, food, fuel, medicines and shelter. Contrary to some reports, there were only isolated cases of looting and fighting. But delay and disarray has cost many lives. The longer it lasts, the more likely that desperation turns to violence. The UN called for more peacekeepers. Brazil offered 800; it may take weeks to muster the rest. If ever a situation cried out for the UN to have a standing army at its disposal, as The Economist has urged, this is it.

From relief to building a better country

Amid such chaos, it might seem premature to think about a long-term strategy for rebuilding Haiti. Actually, it is vital. Already Haitians’ resilient response to disaster is creating new facts on unstable ground: the spontaneous refugee camps around the capital will be hard to shift. Even before the earthquake Haiti was poor, environmentally degraded and aid-dependent and had few basic services. This means that “building back better” must be more than just a slogan. It also means that time is short before the world’s generosity turns to cynicism.

Fortunately there is a blueprint, drawn up by Haiti’s government and presented to donors last year. It calls for investment to be targeted on infrastructure, basic services and combating soil erosion to make farmers more productive and the country less vulnerable to hurricanes. The pressing question is who should do it and how. Haiti’s government is in no position to take charge, yet the country needs a strong government to put it to rights. Paul Collier, a development economist who worked on the plan, reckons that the answer is to set up a temporary development authority with wide powers to act.

Given the local vacuum of power, this is the best idea around. The authority should be set up under the auspices of the UN or of an ad hoc group (the United States, Canada, the European Union and Brazil, for example). It should be led by a suitable outsider (Bill Clinton, who is the UN’s special envoy for Haiti, would be ideal, perhaps to be followed by Brazil’s Lula after he steps down as president in a year’s time) and a prominent Haitian, such as the prime minister. To provide services, it should work with aid groups.

Some will object that this would undermine a democratically elected government. But there is not much left to undermine. Done well, it could create a state in Haiti able to do more than preside over chaos and corruption. Otherwise the suffering of the past ten days risks being repeated.

In theory, CER sounds like a calm, academic subject: evaluate different treatment options for a given illness — drug A vs drug B, or drug A vs surgery — and determine which does a better job of reducing morbidity and mortality. You also can go a step further and compare these treatment options in terms of risks or cost-effectiveness: Does drug B outperform drug A by a 2% margin but cost 3 times as much? Experts say such research is in short supply, leading to poorer clinical outcomes and runaway costs.

However, talk of government-sponsored CER pushes hot buttons in medicine and American society alike, being called “rationing” and “government takeover of medicine.” For proof, consider what happened when the US Preventive Services Task Force announced last November that, based on the scientific evidence it weighed, it no longer recommends mammograms for women aged 40 through 49 years. The task force also recommended that women aged 50 years and older no longer receive annual mammograms but, instead, get them every other year. Public outcry and pushback from several medical societies and expert groups like the American Cancer Society swayed Senate Democrats to rewrite their pending healthcare reform legislation to guarantee mammogram coverage.

If Congress enacts healthcare reform, more such medical recommendations could roil Americans. That’s because reform bills passed by the House and Senate (which have yet to be reconciled) call for the creation of a CER entity that would question the value of many trusted procedures and treatments. These provisions come on top of economic stimulus legislation passed in early 2009 that pumps $1.1 billion into CER and establishes a new federal bureaucracy to manage it. The government would not conduct CER itself by and large but would instead fund the work of academic investigators.

NEJM Authors Bolster Support for CER Individual physicians and medical societies approach CER with varying degrees of enthusiasm, cautious support, and downright fear and loathing. The 2 recent NEJM articles seek to bolster support for this controversial discipline. Two professors at Weill Cornell Medical College, New York City, write in an article titled “Health Care Reform and the Need for Comparative-Effectiveness Research” that CER is “physicians’ first line of defense against blind cost containment.” Furthermore, it could spur drug and medical device manufacturers “to develop products that really matter.” “I think CER is the physician’s best friend,” coauthor Alvin Mushlin, MD, professor and chair of the Department of Public Health at Weill Cornell, told Medscape Medical News. Similarly, the other NEJM article, titled “Comparative Effectiveness and Health Care Spending — Implications for Reform,” warns that without a shift to best-bang-for-the-buck services identified by CER, cost-cutting alone could produce worse health outcomes. “If we can induce hospitals and health plans to improve efficiency and not just cut costs, then health costs in the United States will come down and outcomes will improve,” write coauthors Milton Weinstein, PhD, a professor of health policy and management at the Harvard School of Public Health, Boston, Massachusetts, and Jonathan Skinner, PhD, a professor of economics at Dartmouth Medical School, Hanover, New Hampshire. Proposed Government-Sponsored CER Would Be Transparent The American Medical Association (AMA) and several other medical societies believe that the federal government can play a valuable role in CER. After all, the cost of this research deters drug and device manufacturers from studying how their products fare in head-to-head competition with others; plus, they may be afraid to tell the world that their product is second-best, according to AMA President J. James Rohack, MD. The government would not operate under these constraints. Furthermore, government-sponsored CER would be a public, transparent enterprise. In contrast, said Dr. Rohack, private payers that conduct CER to determine what they’ll cover don’t always reveal how they’ve reached their decisions — the proverbial, and hated, black box. “You don’t know if they’re just trying to maximize profits or if science backs up their coverage determination,” Dr. Rohack told Medscape Medical News. Accordingly, the AMA and its medical allies have mostly supported provisions in healthcare reform legislation that make the federal government a player in CER. The House bill establishes a Center for Comparative Effectiveness Research within the Agency for Healthcare Research and Quality in the US Department of Health and Human Services. Findings from this center could not be construed as mandates regarding treatment, coverage, or payment, but some experts interpret the legislation as giving the center the ability to make recommendations. In contrast, the Senate bill would create a nonprofit, independent Patient-Centered Outcomes Research Institute that is confined to only publishing its findings and is explicitly prohibited from issuing even recommendations. The AMA prefers the Senate approach because it’s more emphatic about denying a CER body any policy-making clout. The association also prefers an independent body. In contrast, the CER center in the House bill would be a fiefdom within Department of Health and Human Services, which also operates the Medicare and Medicaid programs. There’s fear in some quarters that a CER group embedded in the federal bureaucracy would be vulnerable to political bullying, with scientific integrity sacrificed on the altar of budget-cutting. However, an independent body also comes with risks, said Neil Kirschner, PhD, a senior associate in regulatory and insurer affairs for the American College of Physicians (ACP), a strong advocate of government-sponsored CER. “The public-private group that the Senate wants could be unduly influenced by the private sector,” Dr. Kirschner told Medscape Medical News. “The ACP hasn’t taken a position on which approach is right.” Dr. Kirschner said the ACP would like government-sponsored CER to freely factor in cost-effectiveness data. “The Senate bill makes this more difficult,” he said. “The House bill is more silent on the use of cost.” Cost-effectiveness, he added, doesn’t necessarily mean adopting the least-expensive treatment. “Sometimes the most expensive treatment may be a better value by helping a person live much longer,” he said. Give Physicians Scientific Findings, Not Recommendations Both the ACP and the AMA agree that a government-sponsored CER body should forgo recommendations, much less mandates, on how physicians should practice medicine. For one thing, private insurers and government programs like Medicare are tempted to turn such recommendations into binding policies that may arbitrarily deny patients coverage for needed care, explained the AMA’s Dr. Rohack. “Look at vaccines,” Dr. Rohack told Medscape Medical News. “The federal Advisory Committee on Immunization Practices recommends what vaccines should be administered, and insurers key off that to determine what they’ll pay for.” The fracas over mammograms last year occurred at the intersection of recommendation and insurance coverage, noted health-policy analyst Dennis Smith from the Heritage Foundation, a conservative think tank. “The essential benefit package in the [original] Senate reform bill was supposed to include preventive services recommended by the US Preventive Services Task Force. So if you didn’t meet the [task force] criteria, you wouldn’t get your mammogram paid for.” Dr. Rohack also pointed to the problem of inflexible application of CER. A study that identifies the best way to treat a particular medical condition may have excluded patients older than 65 years, for example. A payer may then decide to cover that treatment, but not for anyone older than 65 years, he said. It’s sufficient, said Dr. Rohack, to give CER findings to physicians and patients and let them make the final decision on medical care. “Physicians by training try to use evidence-based science to do what’s best for patients,” he said. “If there is a gray zone, they’ll rely on history, experience, and local practice styles. And there are gray zones.” Dr. Rushlin at Weill Cornell Medical College agrees with Dr. Rohack that merely publishing CER findings without adding recommendations will benefit healthcare. “We need to get started incorporating information from CER into the public debate on healthcare. It can be a very positive step in the right direction,” he said. “When you put the evidence on the table, it illuminates the discussion. It doesn’t eliminate the discussion. That’s healthy.” Rationing With a Light Touch? Despite all the restrictions in the House and Senate healthcare reform bills, government-sponsored CER alarms some physicians, such as the American Association of Physicians and Surgeons. An opponent of reform legislation, the society states on its Web site that CER “will provide the rationale for rationing” and suggests that this discipline is a reincarnation of managed care. Sen. Thomas Coburn, MD (R-OK), wrote in the Wall Street Journal last month that CER is one reason why “seniors will die sooner” if Congress passes the Senate’s version of healthcare reform. In other countries, such as the United Kingdom, Dr. Coburn wrote, CER panels amount to rationing panels. Dr. Weinstein and Dr. Skinner acknowledge in their article that Americans have less of a stomach for explicit, top-down rationing of healthcare resources than other countries in which CER has a longer history. The authors point out, however, that Americans appear more amenable to rationing when it’s based on free-market price decisions, such as whether to pay a higher copayment for more expensive medication. With that tendency in mind, Dr. Weinstein and Dr. Skinner suggest several ways to coax patients and providers to veer toward cost-effective care without getting heavy-handed about it. Physicians and hospitals could receive higher compensation when they perform more cost-effective services, and lower compensation when they choose more wasteful services. Likewise, consumers purchasing insurance could pay a higher premium for a plan that would give them immediate access to higher-cost medications, for example, without first having to try less expensive ones — read generics — to see whether they work. N Engl J Med. Published online January 6, 2010.

The plan, which would guide Florida hospitals on how to ration scarce medical care during a severe flu outbreak, also calls for doctors to remove patients with poor prognoses from ventilators to treat those who have better chances of surviving. That decision would be made by the hospital.

The flu causes severe respiratory illnesses in a small percentage of cases, and patients who need ventilators and are deprived of them could die without the breathing assistance the machines provide.

In June, Florida Surgeon General Ana M. Viamonte Ros sent the draft guidelines — which had already undergone a series of internal revisions — to 16 state medical organizations for their feedback.

But the state has not yet publicized the guidelines or solicited input from the general public. The Florida Department of Health released a copy of the draft plan at the request of ProPublica, a nonprofit news organization, which provided it to the Sun Sentinel.

The document addresses one of the most heart-rending issues in medicine: What to do if the number of people in need of ventilators and other treatment dramatically exceeds what is available.

The goal, the plan says, is to focus care on patients whose lives could be saved and who would be most likely to improve. While it says those decisions are not to be made based on patients’ perceived social worth or role, the plan calls for different rules for some populations.

The list of conditions that disqualify hospital admission would be applied to most people only in the two most severe levels of a pandemic. However, they would also be applied in the first level ofa pandemic for patients transferred to hospitals from “other institutional facilities,” such as nursing homes and mental health facilities.

Florida’s planning effort reflects a growing acknowledgment that hospitals across the nation would be unable to cope with the flood of patients that a severe influenza pandemic, like the one that gripped the nation in 1918, would unleash. That resource gap is in the spotlight now, as the country is battered by a second wave of pandemic swine flu, also known as the H1N1 virus.

“What we have seen are real stresses, particularly on the emergency departments,” Thomas Frieden, commissioner of the Centers for Disease Control and Prevention, said at a press conference last week.

The H1NI virus is much milder than the 1918 flu, but a small proportion of H1N1 patients, including some who have no risk factors and are young and healthy, develop severe breathing problems requiring mechanical ventilation and life support.

So far, intensive care units in the U.S. haven’t been overwhelmed with people needing ventilators.

“That’s something that we’re tracking closely,” Frieden said.

In Winnipeg, Canada, all regional critical care beds were full at the peak of the outbreak last spring, and in Mexico, patients experienced long delays before being admitted to ICUs. Four died before being transferred from the emergency room.

Florida health officials believe that the number of severely ill flu patients will likely remain at a manageable level, provided residents get vaccinated, that they know when to stay home and when to seek medical care (visit myflusafety.com or call               877-352-3581         877-352-3581 for information), and that the existing flu strain does not mutate into a more virulent form.

In the case of a much severer scenario, Florida’s draft guidelines call for hospitals to turn away anyone whose doctor has signed a “Do Not Resuscitate” order, which instructs rescuers not to revive a patient whose heartbeat or breathing stops.

A recent report from a panel of national experts convened by the Institute of Medicine urged states not to use DNR orders for this purpose, because they reflect preferences about end-of-life planning “more than an accurate estimate of survival.”

The Florida plan also calls for intensive care unit patients and those using ventilators to be reassessed after 48 to 72 hours.

Those whose chances of survival have significantly worsened would be taken off the machines or discharged from critical care to make way for others who may have a better chance of survival. If needed, they would be given palliative care to keep them comfortable.

One goal of Florida’s plan is to “reduce or eliminate” the legal liability of health care workers who, in good faith, deny or withdraw treatment from some patients in an emergency. The plan includes sample executive orders that the governor could issue to shield workers and authorize hospitals to implement the guidelines.

The draft document also outlines how the health care system should stretch critical resources before moving to ration care.

The guidelines suggest reusing supplies, canceling surgeries that are not absolutely necessary, training staff to perform additional tasks and drawing on stockpiles. The general public’s responsibilities include treating certain sick family members at home and monitoring public health messages.

Florida’s draft guidelines aim to provide the “greatest good for the greatest number” when doing the best for all patients is no longer possible.

That goal needs to be balanced with an effort to distribute scarce resources in the least discriminatory way, said professor Ken Goodman, who directs the University of Miami bioethics program and the Florida Bioethics Network.

“Among the ways we can do that is to somehow take the evidence about what we think works and bolt it to the values that I think are uncontroversially shared: Namely, life is good, suffering is bad.”

He said that methods included in the draft are still imperfect: “It’s a very difficult problem to figure out how the world of science can help ensure that our strategies for allocating resources are fair and effective.”

Viamonte Ros will have final approval authority and the plan will remain voluntary and subject to review, according to Doc Kokol, the health department’s information officer.

The Florida health department’s original goal was to have a final draft of the plan ready by December.

But with public health workers scrambling to cope with other aspects of the H1N1 pandemic, that is now unlikely, state officials said.

“People would like to have that policy,” said Goodman, who chaired an ethics meeting on these issues at Jackson Memorial Hospital in Miami last week. He said that staff at the hospital have drawn up their own draft plan to cope with a potential surge of patients needing care. Florida plans to accept public input after the guidelines are revised by health officials. Kokol wrote in an e-mail that that “will likely include regional meetings for public input as well as electronic receipt of comments.”

In many states, that type of input has been largely absent. Groups of doctors, lawyers and ethicists have hammered out the plans with little engagement with the public or with groups that represent children, the elderly and those with chronic illnesses or disabilities.

When Utah tested a similar plan in late August, the drill revealed difficulties that Florida clinicians and patients are likely to encounter.

Utah family physician Pete DeWeerd had to tell a mock patient’s mother that her 7-year-old daughter, who had cerebral palsy and was suffering from the flu, would be turned away from the hospital and likely die.

“I don’t like to tell you this,” he said he told her, “it feels unfair, but our list is our list is our list.” He added: “It was awful. You get a huge lump in your throat.”

Dr. Tom Kurrus, medical director of St. Mark’s Hospital in Salt Lake City, called it “emotionally draining” when mock patients and family members yelled, screamed and took issue with who was denied treatment.

“The major weakness in our preparedness had to do with security,” he said.

Kurrus said that although the exercise was covered widely in Utah’s media, the public isn’t aware that the disaster plans call for rationing.

“Even with the scenarios played out and the discussions entertained, they still don’t understand,” he said. “It’s, ‘Why can’t I get into the hospital, why can’t grandma get put on a respirator?’”

Goodman, the University of Miami ethicist, said open conversation about the complex, value-laden decisions that will determine who receives treatment in the most extreme circumstances is crucial, and that hospital, state or federal guidelines should always be subject to revision.

“This should be an ongoing process that includes new evidence as it becomes available and that includes, in an open society, the participation of citizens,” he said.

Sheri Fink is a reporter for ProPublica, a nonprofit journalism organization in New York City. To see more of her stories about emergency preparedness, go to propublica.org/sherifink

http://www.sun-sentinel.com/news/nationworld/sfl-swine-flu-crisis-propublica-sboct18,0,2027387,full.story

[nytimes]  Melissa J. Whitaker has one very compelling reason to keep up with the health care legislation being written in Washington: her second transplanted kidney.

The story of Ms. Whitaker’s two organ donations — the first from her mother and the second from her boyfriend — sheds light on a Medicare policy that is widely regarded as pound-foolish. Although the government regularly pays $100,000 or more for kidney transplants, it stops paying for anti-rejection drugs after only 36 months.

The health care bill moving through the House of Representatives includes a little-noticed provision that would reverse the policy, but it is not clear whether the Senate will follow suit. The 36-month limit is one of several reimbursement anomalies — along with inadequate primary care payments and incentives that encourage unneeded care — that many in Congress hope to cure.

Ms. Whitaker, 31, who describes herself as “kind of a nerd,” has Alport syndrome, a genetic disorder that caused kidney failure and significant hearing loss by the time she was 14. In 1997, after undergoing daily dialysis for five years, she received her first transplant. Most of the cost of the dialysis and the transplant, totaling hundreds of thousands of dollars, was absorbed by the federal Medicare program, which provides broad coverage for those with end-stage renal disease.

Despite that heavy investment, federal law limits Medicare reimbursement for the immunosuppressant drugs that transplant recipients must take for life, at costs of $1,000 to $3,000 a month.

Once Ms. Whitaker’s Medicare expired, she faced periods without work and, more important, without group health insurance, which disregards pre-existing conditions. Struggling financially, she soon found herself skipping doses of anti-rejection drugs.

By late 2003, her transplanted kidney had failed, and she returned to dialysis, covered by the government at $9,300 a month, more than three times the cost of the pills. Then 15 months ago, Medicare paid for her second transplant — total charges, $125,000 — and the 36-month clock began ticking again.

“If they had just paid for the pills, I’d still have my kidney,” said Ms. Whitaker, who shares an apartment in the La Jolla neighborhood with her boyfriend, Joseph D. Jamieson. “I’d be healthy, working and paying taxes.”

The Medicare program is not sure how many of the country’s 100,000 transplant recipients are without insurance for their immunosuppressant drugs. Officials with the National Kidney Foundation said some dialysis patients never put themselves on transplant lists because they fear that they will not be able to afford the drugs.

Currently unemployed, Ms. Whitaker is nervous that in two years she will again find herself without health coverage. She and Mr. Jamieson, who have been together five years, said they would marry if necessary so he could insure her under the group policy provided by his employer, the drug manufacturer Pfizer. But nothing is guaranteed.

“If Joe were ever to lose his job or medical coverage, I do feel it would be possible for me to find myself without insurance again,” said Ms. Whitaker, who reads lips to compensate for her hearing loss. “I’m extremely nervous about whether I’m going to be able to afford my medications once my coverage runs out.”

Bills have been introduced in Congress since 2000 to lift the 36-month limit and extend coverage of immunosuppressant drugs indefinitely. They have never made it to a vote, largely because of the projected upfront cost; the Congressional Budget Office estimates that unlimited coverage would add $100 million a year to the $23 billion Medicare kidney program.

But the cost-benefit analysis would seem obvious. The most recent report from the United States Renal Data System found that Medicare spends an average of $17,000 a year on care for kidney transplant recipients, most of it for anti-rejection drugs. That compares with $71,000 a year for dialysis patients and $106,000 for a transplant (including the first year of monitoring).

“It doesn’t make any sense at all,” Ms. Whitaker said. “Somebody’s not looking at the numbers.”

A provision to cover the drugs is in the sweeping House health care bill, which has cleared three committees. It is uncertain whether the Senate Finance Committee will include it in its bill.

Since 1973, end-stage renal disease has been the only condition specifically covered by Medicare regardless of age. In 1988, coverage was extended for 12 months to anti-rejection drugs, which had recently been developed. Congress gradually lengthened the cutoff to 36 months, and then in 2000 made the benefit unlimited for those who are at least 65 or disabled. The rationale for leaving out younger transplant recipients was simply that the money was not there, Congressional aides said.

Ms. Whitaker was married when her Medicare eligibility expired after her first transplant, and her husband was able to insure her under his group policy. They divorced in 2001, and she became uninsured until taking a job at Kinko’s that provided health benefits.

Her downward spiral began the day she awoke to find that her dog had used her hearing aids as a chew toy. She could not afford replacements and had to leave her job because she was unable to interact with customers.

She lived in Seattle for a while without electricity or hot water. The bank repossessed her car, and she filed for bankruptcy. Her grandmother eventually bought her new hearing aids, and she went back to work. But she was laid off a year later.

“That’s when I started stretching out the pills,” she said. “I’d take one in the morning and one at night, instead of two. Toward the end, I ran out of pills and was taking nothing for a couple of months. I figured I was young and could make it until I found insurance.”

She figured wrong. When she arrived at an emergency room, weak from weight loss and anemia, her doctors told her they were surprised she was not in a coma. The kidney, they said, had not been functioning at all.

“I felt really guilty because it was my mom’s kidney and I broke it,” Ms. Whitaker said.

Ms. Whitaker moved back to Southern California to live with her mother, and soon met Mr. Jamieson. He is seven years younger and, at 6-foot-8, stands 16 inches taller, but they had what Mr. Jamieson calls “a mutual dork synchronicity” (they share a passion for video games). He bought her a stuffed kidney, with a ureter nose, and almost immediately offered her one of his kidneys.

She declined. “I didn’t want to start dating somebody and steal his kidney,” she said. “That seemed kind of rude.”

Several years later, she reversed course and accepted the transplant on June 10, 2008. She has suffered several minor rejection episodes, but lately has been feeling well.

The couple gets by on Mr. Jamieson’s paycheck and Ms. Whitaker’s Social Security benefits. With the help of financial aid, she recently completed two years at a community college and will soon start classes at the University of California, San Diego. She said she hoped a degree would help her find a job with health coverage, perhaps as an addiction counselor.

But her bigger hope is that Congress will eliminate the 36-month limit so she can pursue any job, without concern for insurance.

“My whole life is dictated by my illness, and it’s such a waste,” Ms. Whitaker said. “If the government is going to spend all that money to help people get a kidney, they should help you keep it.”

The study results are striking. By surveying 46 healthcare professionals, Rottman and co-authors highlight that hospital clinicians are unaware of the general and ethical challenges that occur during a pandemic. Moreover, the study shows that when hospital clinicians are made aware of the potential challenges, including triage and resource allocation decision scenarios, they are “quickly overwhelmed” and unable to reason through the scenarios and/or draw upon cohesive and consistent response action plans. This study is immensely helpful in that it demonstrates the acute preparedness and knowledge gaps regarding ethical decision- making, although the results would be statistically stronger with a larger respondent pool. This information is highly relevant because a failure by the clinical community to make ethical decisions in a pandemic not only exposes the clinician and his or her hospital to legal liability, but also is likely to lead to a failure to save the most amount of lives possible. For example, without preparedness in ethical decision-making, a clinician may decide to allocate resources and provide care on a first-come, first-served basis or lottery system. Although these two systems might seem superficially fair, this type of decision-making is not likely to maximize the total number of lives saved. Additionally, because select survey responses extend beyond pandemics to include bioterrorism and disasters generally, the study results may be applicable for consideration in multiple hazard disaster planning.

Continue reading editorial and study results at the journal of Prehospital and Disaster Medicine.

1.  whether receipt of posttrial services constitutes a fair benefit or an undue inducement to research participants,[1-4]
2. whether providing posttrial services unfairly prioritizes research participants over other community members,[5-7] and 
3. whether an obligation to provide such services creates an excessive burden for trial sponsors, thus reducing their incentive to conduct research.[5,6]

In addition, particularly for trials conducted in resource-limited settings, it has been suggested that local governments and nongovernmental organizations may be better suited than trial sponsors to provide posttrial services.^[7-9]

Limited survey data suggest that patients may have strong desires and expectations to receive posttrial services.

• 98% of participants in an international HIV trial stated that an efficacious study drug should be provided after trial conclusion to, at minimum, trial participants;
• 81% of these participants stated that the medication should be provided to all HIV-infected patients in the world.^[1]

In a second study, patients also felt that trial participants should receive lifelong medical care for both trial-related and -unrelated conditions.^[10] There is little published literature on expectations regarding posttrial services, or receipt of such services, for patients with conditions other than HIV infection.

Accurate expectations regarding posttrial services by research participants, investigators, and human subjects committee members may be particularly important for trials of antiretroviral drugs (ARVs) for HIV infection, given recent evidence of clinical risks following treatment interruption.^[11-13] However, providing long-term ARVs requires infrastructure, personnel, and clinical and laboratory monitoring that add substantial costs to the expense of ARVs alone and may not be available after trials conclude in resource-poor locations.^[6]

Despite the importance of posttrial services, international research guidelines offer few specific recommendations regarding these services.^[14-21] The Declaration of Helsinki asserts that posttrial access to interventions studied in trials should be “assured” to trial participants and that plans for posttrial services should be explicitly described in trial protocols.^[14] However, other widely cited research guidelines, including those of the US National Institutes of Health (NIH) Division of AIDS,^[15] state only that post-trial access to medications and medical care should be “considered” in the trial planning process.^[16-21]

Protocols and informed consent forms (ICFs) comprise important sources of information regarding trial procedures and trial-related benefits to participants, investigators, and human subjects committee members. Our objective was to characterize the ways in which posttrial services are described in protocols and ICFs of ARV clinical trials. We conducted a systematic review of trial protocols and template ICFs, and we report on the frequency with which these documents explicitly mention and/or offer to provide posttrial medications and medical care to trial participants.

Method

Clinical Trials Included

We identified all eligible Phase 3 and Phase 4 ARV trials in adults, sponsored by either the pharmaceutical industry or the NIH. Phase 3 trials were included to capture investigational medications with a high probability of demonstrating efficacy but not yet commercially available, thereby creating a situation in which they would be desired by participants after trial completion. Phase 4 trials were included to evaluate situations in which patients might be expected to have another means of obtaining the study medication after trial completion, for example by prescription through their usual means of obtaining medical care.^[22]

We used different methods to identify three types of trials. Industry-sponsored Phase 3 trials were identified from US Food and Drug Administration (FDA) drug approval documentation records.^[23] Industry-sponsored Phase 4 trials were identified from the international Clinicaltrials.gov registry maintained by the NIH.^[24] NIH-sponsored trials were limited to those administered through the adult AIDS Clinical Trials Group (ACTG), the largest NIH-sponsored HIV trials network, and were identified from the ACTG protocol-specific Web pages.^[25] Trials were selected according to the following inclusion and exclusion criteria ( Table 1 ).

All Trials. For all categories of trials, we included stand-alone studies of ARV trials in adults (≥12 years old) conducted during or after 1987 (the year in which zidovudine was approved for treatment of HIV). The analysis was limited to trials completed by December 13, 2006 to improve the willingness of pharmaceutical companies to share confidential trial documents.

Phase 3 Trials. Industry-sponsored Phase 3 trials were limited to all trials identified as the “pivotal” trials leading to FDA approval of single-formulation HIV medications for adults. The FDA Center for Drug Evaluation and Research (CDER) documents the licensing process for all approved HIV medications and designates specific Phase 3 trials as the “pivotal” sources of data used for approval.^[23] Pivotal trials were chosen to create a reasonably sized sample of industry-sponsored trials that spanned nearly 20 years, both before and after introduction of highly active antiretroviral therapy. In addition, all ACTG-administered Phase 3 trials were included.^[25]

Phase 4 Trials. All industry-sponsored Phase 4 ARV trials registered on Clinicaltrials.gov were included.^[24] All ACTG-administered Phase 4 trials were included.

Document Procurement and Data Extraction

We attempted to obtain the protocols and ICFs of all eligible trials. Protocols and ICFs for industry-sponsored trials were obtained by direct request from the sponsoring pharmaceutical companies. Confidentiality agreements were executed between the investigators and all pharmaceutical companies requesting such documentation, ensuring that drugs and trials would be de-identified in all reports. Although we attempted to obtain documents for all remaining trials from the FDA via the Freedom of Information Act, these documents are proprietary and are not subject to this Act (CDER, e-mail communication, Nov. 2, 2006). ACTG protocols and template ICFs were provided by ACTG staff. This research was approved by the Human Subjects Committee of the Massachusetts General Hospital.

Only trials for which complete protocols and ICFs were available by July 1, 2008 (18 months after study initiation) were included. All protocols, appendices, amendments, and template ICFs were reviewed in full by the first author. Missing data were obtained from the ACTG Website and Clinicaltrials.gov when available.

Trial Characteristics and Services Provided to Participants During Trial Periods

Data were collected regarding the date and version number of the last available protocol/amendment, location of trial sites (United States, other developed setting, or resource-limited setting), sponsorship (industry or NIH [ACTG]), anticipated number of participants, age and gender inclusion criteria, and trial duration. Data were also collected regarding additional services offered to participants during the trial period. These included on-study provision of the study drug itself, other required ARVs (”background regimen”), and substitute drugs (as needed for drug toxicity or virologic failure). We also recorded mention or offer of payment for study participation (worded as “payment,” “compensation,” or “reimbursement,” including offers to compensate subjects for time, transportation costs, or child care costs), and mention or offer of payment for care for trial-related injury. These variables were recorded as comparators for services offered after trial conclusion and in order to test a priori hypotheses regarding trial characteristics associated with the primary and secondary outcomes.

Outcomes

The clinical trial was the unit of analysis. The primary outcome was any mention of posttrial services, defined as any text regarding medications or medical care following trial conclusion. Amendments extending the duration of previously enrolled trials met this definition only if they referred to services to be provided after the conclusion of the last described trial phase.

Associations between trial characteristics and the primary outcome were examined using chi-square exact tests with an alpha level of 0.05 (SAS 9.1; SAS Institute, Cary, North Carolina, USA). Multivariate analyses were planned but were precluded by the small sample size. We hypothesized that posttrial services would more frequently be mentioned in the documents of (a) trials with protocols written after 2000 (compared to those written before 2000), reflecting increased awareness of international research ethics guidelines; (b) Phase 3 trials (compared to Phase 4 trials), reflecting a finite period of anticipated need for medications between trial completion and drug licensure; (c) pharmaceutical industry-sponsored trials (compared to NIH/ ACTG-sponsored trials), reflecting greater financial resources for provision of posttrial services and 2005 NIH guidelines stating that posttrial medications would not be supplied;^[15] (d) trials conducted in developed settings (compared to those conducted in resource-limited settings), reflecting lower levels of anticipated need for posttrial services due to private or public insurance; and (e) trials offering to provide payment for participation or care for trial-related injury during the trial periods (compared to trials not offering such services), reflecting a greater overall willingness to provide services to participants.

For trial documents in which posttrial services were mentioned, secondary outcomes included whether trial documents offered to provide medications or offered to provide medical care to participants after trial completion. If posttrial medications or medical care were offered, information was extracted regarding (a) the type of medications or care offered, (b) which participants were eligible to receive these services, (c) the duration for which these services were offered, and (d) who was to pay for medications or care.

Results

Trial Characteristics and Services Provided to Participants During Trial Periods

Sixty-five trials met criteria for inclusion; documents from 31 of the 65 eligible trials were obtained. Reasons for lack of availability of the remaining documents are detailed in Table 2 . Trials ranged widely in number of participants (range, 30-3236; median = 325) and in duration (range, 16-416 weeks; median = 103 weeks) ( Table 3 ). On average, ACTG-administered trials occurred earlier (1987-2004) than industry-sponsored trials (1996-2005). Fifty-eight percent of trials were conducted entirely within the United States, and only two trials (6%) were conducted entirely in resource-limited settings (one each in South Africa and Brazil).

Provision of Antiretroviral Drugs. During the trial periods, all but one trial offered all necessary study drugs to participants ( Table 4 ). In 16 trials (52%), additional “background” ARVs were required; 6 trials (19%) required participants to obtain these medications from sources outside of the study, 9 trials (29%) provided background ARVs completely or partially, and 1 trial (3%) did not specify whether background ARVs would be provided. In the event of virologic failure or toxicity requiring substitutions in study drug or background ARVs, three trials (10%) provided any needed substitute ARV; eight trials (26%) provided selected substitute ARVs only; and four trials (13%) stated that substitute ARVs were permitted but not provided. In 15 trials (48%), no substitute ARVs were available, primarily because a need for substitution necessitated study discontinuation.

Mention of Payment for Study Participation. Documents from 23 trials (74%) explicitly mentioned whether participants would be paid for trial participation ( Table 4 ). Eight trials (26% of total trials) specified that participants would be paid, and trials (48% of total trials) stated that participants would not be paid.

Mention of Payment for Care for Trial-related Injury. Documents from 29 trials (94%) explicitly mentioned whether participants would receive reimbursement for care for any trial-related injury ( Table 4 ). Seventeen of these (55% of total trials) stated that injury care would be reimbursed, and trials (39% of total trials) stated that such care would not be reimbursed.

Mention and Offer of Posttrial Services

Mention of Posttrial Services. Posttrial services of any type were mentioned in the documents of 14 trials (45% of trials, 54% participants; Table 5 ). Documents from 12 trials (39% of trials, 44% of participants) mentioned posttrial medications. Documents from five trials (16% of trials, 28% of participants) mentioned posttrial medical care. Not mentioning or providing payment to participants, as well as anticipated enrollment greater than the median, were significantly associated with mentioning any posttrial service and with mentioning posttrial medications ( Table 6 ). Enrollment greater than the median, trial sponsor (NIH/ACTG), and not offering payment for injury care (a characteristic of all ACTG trials) were significant correlates of mentioning posttrial medical care.

Offer to Provide Posttrial Medications. Of the 12 trials mentioning posttrial medications, 10 offered to provide medications after trial conclusion (32% of trials, 34% of participants), and 2 stated that posttrial medications would not be provided (6% of trials, 9% of participants). Not mentioning or providing payment to participants, anticipated enrollment greater than the median, and inclusion of at least one trial site in a resource-limited setting were significantly associated with offering to provide posttrial medications. Of the 10 trials offering to provide posttrial medications, 7 were industry-sponsored trials. Seven offered study drug, and one offered study drug with background ARVs. Six trials offered posttrial medications to all study completers; two offered posttrial medications only to participants completing the study drug arm. Two additional trials offered the “best available alternative treatment” after trial conclusion (one of these at participant expense), although this was limited to participants failing zidovudine in the late 1980s, when few alternative HIV therapies were available. Six trials offered posttrial medications until commercial availability or for a defined period thereafter, one until a rollover protocol enrolled, and three for an unspecified duration. Posttrial medications were offered at sponsor expense in eight trials, at participant expense in one trial, and without specified payer in one trial.

Offer to Provide Posttrial Medical Care. Of the five trials mentioning posttrial care, one (3% of trials, 2% of participants) offered to provide posttrial medical care. This was further explained as the “best available care” for participants failing zidovudine in the late 1980s, offered at participant expense. In the remaining four trials (13% of trials, 26% of participants), documents stated that post-trial care would not be provided.

Trial Characteristics Not Associated with Primary Outcomes

Calendar year of trial documents was not associated with mention of any posttrial service or offer of posttrial medications; 42% of documents from trial documents written before 2000 and 47% of trial documents written after 2000 mentioned any posttrial service (p = 1.0). In addition, trial phase (Phase 3 compared to 4), trial duration, age inclusion criteria, and provision of background or substitute ARVs were not associated with mentioning any posttrial service or with offering posttrial care. Because only one trial offered posttrial medical care, bivariate analysis was not performed for this outcome. The small number of trials reviewed precluded multivariate analysis of the associations between trial characteristics and mention or offer of posttrial services.

Discussion

Accurate expectations regarding access to medications and medical care after clinical trial conclusion are crucial to informed decision making by research participants, investigators, and human subjects committee members. This may be particularly true in the case of trials of antiretroviral drugs for HIV infection, after which participants who lack access to effective, combination ARVs may experience clinical deterioration.^[11-13] To our knowledge, this study represents the first published review of descriptions of posttrial services in clinical trial documents.

In this sample of major Phase 3 and 4 ARV trials, posttrial medications and medical care were mentioned in the protocols or ICFs of fewer than half (45%) of all trials. Plans regarding payment for trial participation (74%) and payment for care for trial-related injury (94%) were explicitly mentioned more often than were posttrial services, suggesting that authors and reviewers of trial documents are more aware of the importance of describing services offered during trial periods than of the need to outline plans for posttrial services. Post-trial services were mentioned in documents from 12 trials, and 10 (70%) of these offered to provide posttrial medications. Of these 10 trials, 70% were industry-sponsored trials, 60% offered medications until they became commercially available, and 80% offered medications at sponsor expense, reflecting current diversity of recommendations and interpretations about posttrial services.

Decisions about whether posttrial services should be provided are complex, because they include discrete and heavily debated questions about what services should be provided (study medications, other medications, or medical care),^[1,10] to whom they should be provided (all study completers, or other community members),^[1,26,27] and for how long they should be provided (until medications become commercially available, or indefinitely).^[10] Several authors have suggested that trial sponsors should assume at least some responsibility for providing posttrial services.^[5,6,16,28] Important roles for investigators, local organizations, and national governments have also been proposed,^[6,7,15,28] with or without sponsor financial support to create enduring local health care capacity.^[9] The extent of sponsor obligation may depend on whether the sponsor is a government agency or a for-profit entity, which might be expected to have greater financial capacity to provide posttrial services.^[27] In support of this concept, the NIH Division of AIDS states that “the NIH’s authority to ‘encourage and support research’ does not extend to providing treatment following the completion of that research.”^[15]

We found no association between mention or offer of posttrial services and the year in which trial documents were written (before or after 2000), although our study had limited power to detect such effects. Although research guidelines began to mention posttrial services in the 1990s,^[16,21,27] the Declaration of Helsinki (2000, revised 2004) was the first such guideline to clearly recommend that posttrial services be mentioned in trial protocols.^[14] Many of the trials included in this review predate these recommendations; however, our limited data suggest that the proportion of trials in which documents mention posttrial services does not appear to have substantially increased after the year 2000. In 2005, the NIH issued guidelines (quoted above) for trials conducted in resource-limited settings, asserting that NIH would not provide posttrial medications and recommending instead that “investigators engage in a dialogue with host countries’ authorities . . . in order to facilitate the inclusion of [ARV trial participants] in available in-country antiretroviral treatment programs.” These guidelines may have increased mention of post-trial services in trial documents; but, by insisting that NIH not provide posttrial medications, they may also have reduced offers of posttrial medications. Documents for the ACTG trials meeting our inclusion criteria were written in 2004 or earlier, and only one was conducted in a resource-limited setting, so these studies were not subject to the 2005 NIH guidelines.

Because of the small numbers of ACTG trials meeting our inclusion criteria, the low proportion of trials provided by pharmaceutical sponsors, and the large number of statistical comparisons made, our conclusions regarding the associations between trial characteristics and mention or offer of posttrial services must be interpreted only as hypothesis-generating. The direction of several statistically significant associations was contrary to what had been hypothesized, for example, mentioning or offering posttrial services was associated with “not mentioning” or “not providing” payment for trial participation, whereas we hypothesized that mentioning or providing payment would suggest a greater overall level of services provided and would be associated with these outcomes. This suggests that other trial factors may explain this association. Similarly, the observed association between not providing injury-related care and mentioning posttrial medical care is explained by a statement common to more recent ACTG trials (1997-2004), specifying that pediatric and pregnancy-related care would not be provided if participants became pregnant during the studies. Numbers of included trials were too small to permit multivariate analysis to further explore these relationships.

Major international research ethics guidelines do not provide specific guidance to researchers regarding posttrial services.^{[14,16,17,19-21]} It is likely that no single recommendation about posttrial services will be appropriate to all research situations, because the specific risks to participants and needs of the communities in which research is conducted will differ between trials.^[2] Instead, it may be helpful to outline a process by which posttrial services can be included among the other risks and benefits considered in the standardized evaluation of all proposed trials.^[2] For example, education regarding posttrial services could be a component of the training required for a Federal-Wide Assurance (FWA) number for human subjects committees.^[29] Additionally, a description of “planned post-trial services” could be added as a required component of trial protocols and ICFs. This might involve a requirement similar to that currently in place for trials that are subject to FDA requirements and that involve at least minimal risk to subjects: ICFs for such trials must include clear descriptions of plans regarding payment for care for trial-related injury, regardless of whether or not such payment will be provided.^[9,14,30]

During the protocol development process, sponsors may be appropriately reluctant to commit to a future obligation to provide posttrial services, due to uncertainty about drug efficacy or about future financial circumstances.^[18,19,31] However, given the very high expectations of some surveyed trial participants,^[1,10] a statement about posttrial services, even one that makes explicit that posttrial services are not guaranteed, may help to ensure that unreasonable expectations do not play a role in decisions about trial participation.

This study has several important limitations. First, documents other than protocols and ICFs (including internal memoranda, sponsor/investigator contracts, and local ICFs) may contain information about posttrial services and were not reviewed in this study. However, with the exception of local ICFs, these additional documents are likely to be less readily available to participants, investigators, and site human subjects committee members than the protocols and template ICFs. Second, we reviewed all available versions of protocols and ICFs, and the definition of “mention of post-trial services” was fulfilled only if such mention referred to the time after the trial period described in that document version was to conclude. Although this definition may incompletely capture the practice in which trial sponsors provide posttrial services through amendments that extend trials until drugs become commercially available, it is consistent with the goal of making planned posttrial services explicit at the time of participant recruitment.

Finally, the eligible sample of 65 ARV trials included only pivotal industry-sponsored Phase 3 trials leading to medication licensure, rather than a complete sample of Phase 3 ARV trials, and included only ACTG-administered trials, rather than all NIH-sponsored trials. Furthermore, the obtained sample included fewer than half of the eligible trials (93% of ACTG trials, but only 34% of industry-sponsored trials).

This sample of reviewed trials may be biased for two reasons. First, the inclusion of only “pivotal” Phase 3 industry-sponsored trials (those leading to medication approval) resulted in a sample of trials of efficacious medications, after which sponsors may be more likely to offer medications than after trials of inefficacious medications. Second, sponsors may have been less willing to share eligible trial documents in which posttrial services were not mentioned. If documents from all 34 unavailable trials did not mention posttrial services, then the total proportion of trials mentioning post services could be as low as 14 of 65 (22%) overall: 47% (7/15) of ACTG studies and 14% (7/50) of industry studies. Both sources of bias would be expected to lead to results indicating that posttrial services are mentioned or offered more frequently than is really the case. Although clearly important limitations of our study, these factors may suggest that the low frequencies of the outcomes that we observed are even more worthy of consideration.

We are aware of no reports of actual rates of receipt of posttrial services by trial participants with HIV infection or other medical conditions. Efforts to characterize trial participants’ expectations regarding posttrial services and their actual rates of receipt of such services remain important directions for future research. In the meantime, trial sponsors should explicitly communicate their plans about posttrial services to trial participants, investigators, and human subjects committees at the time of protocol approval and participant recruitment, whether or not they intend to provide such services. This could be accomplished by including clear descriptions of plans for posttrial services in trial protocols and informed consent forms. This review suggests that such explicit statements are not yet the standard practice in major HIV clinical trials.

Using false and misleading scare tactics, Conservatives for Patients Rights, a group opposed to comprehensive health care reform, announced last week a $1 million ad attacking comparative effectiveness.

However, an emerging consensus of strange bedfellows – from insurance companies to the Institute of Medicine to patients rights advocates – all support making a national investment in research to compare the effectiveness of drugs, devices and diagnostic procedures, and sharing the information that results with physicians and patients. The enthusiasm for comparative effectiveness research is also strong in the Obama administration and among health care leaders in Congress.

Comparative effectiveness research could have a profound, positive effect on how medical decisions are made. Currently, there are three main drivers in medical decision-making: advertising and promotion by drug and device companies; coverage decisions by insurance companies; and medical science and experience. The first two, as we all know, can work against the interests of patients. They are supposed to be balanced by the third driver – medical science and experience. The problem is that, for many important medical decisions, there is no medical evidence about which treatments or which diagnostic tests work best for which patients.

In those cases, because doctors and patients lack objective facts about what’s best, they often can’t challenge the other two powerful forces.

For instance, what kinds of patients with low back pain require back surgery and which recover with physical therapy alone? Which of the many drugs for high cholesterol or osteoporosis are best for whom? Definite answers to these questions could make a huge difference in peoples’ lives. For example, a recent comparative effectiveness study found that patients with multi-vessel coronary artery disease who had stents implanted did much better with blood flow tests and angiography than with angiography alone.

Comparative effectiveness would allow patients and doctors to make decisions together based on the best possible scientific evidence, giving patients real choices based on solid information. An uninformed choice is like no choice at all.

It would also improve the quality of the medical care that patients receive, not only by identifying what works best but also by identifying what doesn’t work at all – and even more importantly, what causes more harm than good. So comparing treatment effectiveness helps physicians to honor another moral value at the heart of medicine, along with that of informed choice: do no harm.

Critics charge that comparative effectiveness research will lead to “one-size-fits-all” guidelines that cater to a non-existent average patient for the sake of making the system more efficient. In fact, patients will be empowered by rigorous, evidence-based recommendations that are specific to the needs of particular patient groups. Research on comparative effectiveness would provide data to help each patient make the best possible choice with his or her doctor.

Patients want the right to make decisions with their doctors in order to pursue what is in their own best interests. Choosing blindly is an empty right; choosing with evidence respects patients’ rights and enhances quality. This is a case in which good ethics demands good facts.

Dr. Sean DiCristofaro will start serving his suspension Friday. DiCristofaro told the medical board he administered the drug after the patient was gasping for breath and his wife requested that everything be done to “keep him comfortable,” according to a consent order signed by the doctor.

Board of Medicine members concluded that DiCristofaro’s use of the drug on a dying patient was inappropriate and violated medical ethics, even though some doctors believe the drug may be appropriate for dying patients in “rare circumstances.”

DiCristofaro, who’s still practicing this week, referred questions Wednesday to his lawyer, Ted Martin, who declined comment.

Martin said the doctor wasn’t commenting out of respect for the patient’s family.

“It’s resolved,” Martin said. “At this point, it’s a closed matter.”

Last May, DiCristofaro told medical board investigators that, in hindsight, his use of the muscle-paralyzing drug Norcuron was an “error in judgment” and that he would not do it again, according to a medical board consent order.

The patient, who was in the intensive-care unit at CAMC Teays Valley Hospital, had advanced alcoholic liver disease. His wife and children had given “do not resuscitate” orders, according to medical board records.

The critically ill patient died on Jan. 4, 2007, about eight minutes after DiCristofaro administered the drug.

In response to the medical board’s complaint against him, DiCristofaro initially said his use of the neuromuscular-blocking drug on the dying patient “was appropriate palliative care under the unique circumstances of a patient suffering from agonal gasping whose death was clearly imminent.”

A doctor from East Carolina University School of Medicine submitted a report on DiCristofaro’s behalf, saying there’s an ethical basis for the use of muscle-paralyzing drugs on sedated patients in rare circumstances to allow them a “peaceful and comfortable” death.

But the Board of Medicine found that the drug’s use didn’t meet the “prevailing standard of medical and ethical care.”

DiCristofaro told board members he wasn’t trying to hasten the patient’s death by administering the drug, but wanted to ease the patient’s pain while he was gasping for breath. DiCristofaro, a family doctor who graduated from Marshall University’s School of Medicine and has been practicing since 1999, said the situation was “clinically difficult and emotionally painful and weighed heavily upon him.”

The Board of Medicine’s complaint committee launched an investigation against DiCristofaro after CAMC Teays Valley Chief Executive Officer Al Michaels sent a letter to the board about the patient’s death and the doctor’s use of the muscle-paralyzing drug.

During the investigation, the committee interviewed health-care professionals, the patient’s family members and medical ethics experts.

In the hours before the patient died, DiCristofaro also gave the patient morphine and other narcotic pain medications to ease pain.

The Board of Medicine does not disclose patients’ names, ages or addresses.

http://www.wvgazette.com/News/200802130764?page=2&build=cache