November 5, 2009
The Work-Up
Costs Surge for Medical Devices, but Benefits Are Opaque By BARRY MEIER
When makers of heart defibrillators wanted Medicare to vastly expand the types of patients eligible to receive the devices, which can cost upward of $25,000, agency officials were skeptical. It was not clear how many of those patients would actually need a defibrillator, a device that can deliver a life-saving shock to restore a faltering heart to normal rhythm.
So government and industry struck a deal back in 2004. Medicare agreed to expand the device’s use, nearly doubling the number of patients who qualified for one. The companies, in return, agreed to pay for a study to see which patients really benefited.
Five years later, Medicare underwrites more than half of the $4 billion the nation now spends annually on defibrillators, but the agency is no closer to knowing how many lives that big investment is saving. That is because the device companies did not finance the study beyond their initial $4 million commitment, and Medicare did not pick up the slack. As a result, researchers still cannot gather data that would identify the types of patients who would most benefit from a defibrillator.
And so, doctors keep implanting costly defibrillators in patients who may not benefit from them. And doctors and patients have no way of knowing whether one producer’s model performs better than a competitor’s.
The picture is no clearer for the many other types of medical devices that taxpayers, through government-run programs like Medicare, underwrite. Every year, for instance, doctors give patients tens of thousands of artificial hips and knees, without having the data to indicate how long they will last or which ones work best, and Medicare picks up the bills.
As Congress seeks to revamp the nation’s health care system, medical devices might seem an inviting target to better control Medicare spending. Outlays on implanted devices stand at about $76 billion annually in this country and are rising at a rate faster than the cost of drugs, according to a recent study by the McKinsey Global Institute, a consulting group. With an aging population in America, Medicare is picking up more of those costs.
But legislation pending in the House and Senate may not help, some experts say, because the proposals do not require device makers to compete on the same ground as other manufacturers — product performance and price.
Medical devices pose unique challenges for lawmakers. Medicare does not set or negotiate prices for the implants. Instead, it pays a flat rate to a hospital for procedures to give a patient a defibrillator or a hip, leaving it up to the hospital to negotiate the price of the device with the maker — a negotiation in which hospitals may have little leverage.
Unlike other hospital products, implants are so-called physician preference items, meaning that doctors — not the hospitals — often choose which manufacturer’s implant to use. It is a decision that can be skewed by a doctor’s relationship to a company and can also undercut a hospital’s ability to negotiate the best price, experts say.
Medicare’s laissez-faire approach has big implications for taxpayers because every year, spending on device-related procedures soars ever higher.
“This is a dysfunctional market if you take the perspective of the consumer or public programs like Medicare,” said Jeffrey C. Lerner, the president and chief executive of the ECRI Institute, a nonprofit organization in Plymouth Meeting, Pa., that evaluates medical devices for clients that include hospitals.
No one questions that implants like defibrillators and artificial hips extend and improve lives. But profit margins on medical devices are also among the highest for any medical products — over 20 percent, in the case of a defibrillator or an artificial hip, according to analysts.
In an effort to slow federal spending, the bill passed by the Senate Finance Committee would require the device industry to pay the government $4 billion a year for five years, with the portions allocated among individual companies based on their market shares. But device makers, including the ones that initially financed the defibrillator study — Medtronic, Boston Scientific and St. Jude Medical — have fiercely resisted the provision, calling it an unfair “tax” that will stifle innovation and cause job losses.
The companies have the support of some elected officials from the device makers’ home states, including Al Franken, the freshman Democratic senator of Minnesota, where Medtronic, the nation’s biggest device producer, and St. Jude Medical and some other device companies are based.
Although a political compromise over the issue is expected, the type of revenue claw-back contained in the Finance Committee bill would do little to address the underlying scientific and economic challenges that devices pose, several experts said.
The big problems, in such experts’ view, is that there is little data available to compare the benefits of competing makers’ products or to determine how much buyers, like hospitals, should be paying for them, said Eugene Schneller, a business professor at Arizona State University in Tempe.
For example, even doctors acknowledge that they typically have little reason to be concerned about a device’s costs when it comes to deciding which one to use. One doctor compared it to giving a car buyer a blank check and letting him choose between a Maserati or Honda.
“You are going to walk out of a dealership with a really nice car, if you don’t have to pay,” said William Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston.
However, unlike a car buyer, who can see a vast array of comparative information about competing products, a cardiologist or an orthopedic surgeon has little if any comparative data when choosing a device.
Also, many doctors are unlikely to shop around, because they tend to stick with a single producer — either because they have been trained on a particular maker’s devices or because they have financial ties to the company.
Meanwhile, hospitals are often hampered in their ability to negotiate prices with device makers because the selling price of a defibrillator or hip joint is not easy to determine. In selling products, device companies have required hospitals to sign contracts that contain confidentiality clauses under which facilities agree not to disclose what they paid for the product.
As a result, a big hospital that is a large-volume buyer of heart devices or hips may pay higher prices than a smaller one that buys fewer units, said Dr. Lerner of ECRI.
In 2007, Senator Charles E. Grassley, Republican of Iowa, helped introduce legislation that would have required device makers to regularly disclose the average selling price for their products. Current health care reform proposals do not contain such a provision, said a spokeswoman for the Advanced Medical Technology Association, the device industry’s trade group.
In some other countries, medical device databases have been established to provide both doctors and patients with more data about how competing products differ. In such a database, or a registry, information about a product and the surgical technique used by a doctor is recorded at the time of an implant. And then by tracking whether and when the patients return for a replacement procedure, or experience other problems, registries can show which producers’ models are failing faster than others.
The information can help doctors and insurers avoid less reliable devices, while also avoiding the high additional medical costs of remedial treatments and replacement procedures.
But while the United States is the world’s largest user of orthopedic devices, efforts to set up registries have largely failed. The result is that orthopedic patients here are twice as likely to require an earlier-than-expected replacement procedure for a hip or a knee than in countries, like Australia, that have registries.
Doctors in such countries often are less eager to embrace newer, more costly models than doctors in the United States because evidence shows that new models are more prone to failure during their initial years of use.
Eliminating unnecessary replacement procedures could potentially save Medicare hundreds of millions annually. But Medicare has not pushed the use of registries, and the industry has also not embraced it. To date, hip and knee producers have contributed $500,000 to underwrite an effort by the American Academy of Orthopaedic Surgeons, a professional group, to create a national artificial hip and knee registry. But that is a relative pittance — about what many individual companies pay to a few doctors each year to retain them as consultants.
Some experts like Dr. Maisel, the cardiologist in Boston, said it was naïve to expect the industry to underwrite registries, because it was not in a company’s interest to see its products compared against those made by competitors.
The federal government could also play a more aggressive role in making sure it is getting better value for its money, he added. A case in point — requiring that makers of heart devices use batteries that last longer than five years, the period of time when patients must now undergo an additional, potentially dangerous operation to have a costly device replaced.
Dr. Maisel said, “Why would you build a better light bulb that lasts longer if it is going to reduce your profits?”
Showing posts with label Medical. Show all posts
Showing posts with label Medical. Show all posts
Thursday, November 05, 2009
Friday, August 07, 2009
Why the case for assisted dying is unanswerable By Samuel Brittan
Why the case for assisted dying is unanswerable By Samuel Brittan
Published: August 7 2009 19:26 | Last updated: August 7 2009 19:26
Let me declare, as parliamentarians sometimes do, an interest. I am neither a legal nor a medical expert, but I am a rather inactive member of Dignitas, a British organisation which campaigns for better-quality palliative care for terminally ill people, but also for “the option of medically assisted dying” when such people “are of sound mind and are experiencing unbearable suffering”. My only qualification is that as an economics writer I have some experience of assessing the costs and benefits of alternative courses of action. Nor am I going to detail the sufferings of terminally ill people who have lost all will to live but cannot find a dignified, legal exit.
I have nothing to say to those religious fundamentalists who consider that in no circumstances should life ever be terminated. I leave it to them to reconcile their views with their belief in a merciful God. They also need to be very sure of their convictions to impose them on the rest of humanity. But for the rest of us, some progress has been made. Attempted suicide is no longer a crime in the UK. There is also an instrument known as a Living Will under which I can declare that if I become “mentally incompetent to express my opinion”, and after two independent physicians agree my condition is irreversible, then certain kinds of treatment should not be given. The legal force of such documents is not clear, but many doctors now take them into account.
Most of the present argument is about “assisted dying” for those of sound mind. There have been notable cases of terminally ill people making accompanied visits to Switzerland, where the law is different. In the UK, assisting or abetting suicide is still a crime theoretically punishable by up to 14 years’ imprisonment. No returning companion has been so prosecuted. When the Law Lords were asked for a ruling by Debbie Purdy , a 46-year-old suffering from multiple sclerosis, who wanted to know whether her husband would be prosecuted if he helped her commit suicide overseas, they requested the Crown Prosecution Service for guidelines. An interim report is expected this September.
There is an overwhelming case for the removal of the threat of a custodial sentence for those who help their loved ones die in any country. Opinion polls show large majorities in favour of such changes, but attempts to enact them have so far failed to get through parliament.
There are many reasons why terminally ill people may want help in taking their own lives. They may lack the pharmaceutical knowledge to choose the least painful or quick acting drug. They may not be able to get hold of such drugs legally. Or in extreme cases they may need physical help in taking them. In some cases they may just want to depart this world surrounded by their nearest and dearest. But under present law there is a risk that their relatives and friends could be prosecuted for aiding and abetting.
The secular case against assisted dying can be put crudely as the fear that the procedure would be abused “to put granny away and take over her house”. Statistical surveys in the Netherlands and the US state of Oregon, where the law has been reformed, show no rise in the number of suicides that would have occurred if there had been such abuses on a significant scale. But I do not want to depend on statistical averages. There would undoubtedly be at least some abuses under a reformed law. But these have to be set against the much greater hardship almost certainly inflicted by the present suicide laws.
A more refined consideration is philosopher Bertrand Russell’s view that the remedy for the pains of old age and fear of death is to identify oneself less with personal concerns and more with the future of the human race. He lived up to his counsel, spending a week in jail at the age of 90 for his anti-nuclear activities and dying at 97 still corresponding with world leaders. But we cannot all be like him. Creative artists have often revelled in the pains and brevity of life. Last week, I went to hear Gustav Mahler’s Sixth or “Tragic” Symphony. After two or three literal hammer blows the work ends with a resounding orchestral crash that never fails to shock. Yet it does not, literally, remove anyone’s pain.
Any new law would have to be carefully drafted. What should be done about those who want to take their lives because of what can only be described as Weltschmerz, or world-weariness? An excellent play, Collaboration, by Ronald Harwood focuses on the German composer Richard Strauss and his Jewish librettist, the Austrian Stefan Zweig. The latter fled to Brazil, where he and his wife took their lives in 1942 because he could not acclimatise to life outside Europe. If, however, Zweig had hung on until 1943 when the war turned in favour of the Allies, life might again have seemed worth living. But you cannot expect the law or the medical profession to play God in such matters.
But to come down to earth. The main reason it is so difficult to reform the law on assisted dying is that those on the fundamentalist side will be prepared to base their votes on this issue, while humanist utilitarians will see it as only one of many issues. Or so ministers fear, which comes to nearly the same thing. Meanwhile my best advice is to make your wishes unmistakably clear while you are still in normal mental and physical health.
www.samuelbrittan.co.uk
Published: August 7 2009 19:26 | Last updated: August 7 2009 19:26
Let me declare, as parliamentarians sometimes do, an interest. I am neither a legal nor a medical expert, but I am a rather inactive member of Dignitas, a British organisation which campaigns for better-quality palliative care for terminally ill people, but also for “the option of medically assisted dying” when such people “are of sound mind and are experiencing unbearable suffering”. My only qualification is that as an economics writer I have some experience of assessing the costs and benefits of alternative courses of action. Nor am I going to detail the sufferings of terminally ill people who have lost all will to live but cannot find a dignified, legal exit.
I have nothing to say to those religious fundamentalists who consider that in no circumstances should life ever be terminated. I leave it to them to reconcile their views with their belief in a merciful God. They also need to be very sure of their convictions to impose them on the rest of humanity. But for the rest of us, some progress has been made. Attempted suicide is no longer a crime in the UK. There is also an instrument known as a Living Will under which I can declare that if I become “mentally incompetent to express my opinion”, and after two independent physicians agree my condition is irreversible, then certain kinds of treatment should not be given. The legal force of such documents is not clear, but many doctors now take them into account.
Most of the present argument is about “assisted dying” for those of sound mind. There have been notable cases of terminally ill people making accompanied visits to Switzerland, where the law is different. In the UK, assisting or abetting suicide is still a crime theoretically punishable by up to 14 years’ imprisonment. No returning companion has been so prosecuted. When the Law Lords were asked for a ruling by Debbie Purdy , a 46-year-old suffering from multiple sclerosis, who wanted to know whether her husband would be prosecuted if he helped her commit suicide overseas, they requested the Crown Prosecution Service for guidelines. An interim report is expected this September.
There is an overwhelming case for the removal of the threat of a custodial sentence for those who help their loved ones die in any country. Opinion polls show large majorities in favour of such changes, but attempts to enact them have so far failed to get through parliament.
There are many reasons why terminally ill people may want help in taking their own lives. They may lack the pharmaceutical knowledge to choose the least painful or quick acting drug. They may not be able to get hold of such drugs legally. Or in extreme cases they may need physical help in taking them. In some cases they may just want to depart this world surrounded by their nearest and dearest. But under present law there is a risk that their relatives and friends could be prosecuted for aiding and abetting.
The secular case against assisted dying can be put crudely as the fear that the procedure would be abused “to put granny away and take over her house”. Statistical surveys in the Netherlands and the US state of Oregon, where the law has been reformed, show no rise in the number of suicides that would have occurred if there had been such abuses on a significant scale. But I do not want to depend on statistical averages. There would undoubtedly be at least some abuses under a reformed law. But these have to be set against the much greater hardship almost certainly inflicted by the present suicide laws.
A more refined consideration is philosopher Bertrand Russell’s view that the remedy for the pains of old age and fear of death is to identify oneself less with personal concerns and more with the future of the human race. He lived up to his counsel, spending a week in jail at the age of 90 for his anti-nuclear activities and dying at 97 still corresponding with world leaders. But we cannot all be like him. Creative artists have often revelled in the pains and brevity of life. Last week, I went to hear Gustav Mahler’s Sixth or “Tragic” Symphony. After two or three literal hammer blows the work ends with a resounding orchestral crash that never fails to shock. Yet it does not, literally, remove anyone’s pain.
Any new law would have to be carefully drafted. What should be done about those who want to take their lives because of what can only be described as Weltschmerz, or world-weariness? An excellent play, Collaboration, by Ronald Harwood focuses on the German composer Richard Strauss and his Jewish librettist, the Austrian Stefan Zweig. The latter fled to Brazil, where he and his wife took their lives in 1942 because he could not acclimatise to life outside Europe. If, however, Zweig had hung on until 1943 when the war turned in favour of the Allies, life might again have seemed worth living. But you cannot expect the law or the medical profession to play God in such matters.
But to come down to earth. The main reason it is so difficult to reform the law on assisted dying is that those on the fundamentalist side will be prepared to base their votes on this issue, while humanist utilitarians will see it as only one of many issues. Or so ministers fear, which comes to nearly the same thing. Meanwhile my best advice is to make your wishes unmistakably clear while you are still in normal mental and physical health.
www.samuelbrittan.co.uk
Sunday, July 19, 2009
Why We Must Ration Health Care By PETER SINGER
July 19, 2009
Why We Must Ration Health Care By PETER SINGER
You have advanced kidney cancer. It will kill you, probably in the next year or two. A drug called Sutent slows the spread of the cancer and may give you an extra six months, but at a cost of $54,000. Is a few more months worth that much?
If you can afford it, you probably would pay that much, or more, to live longer, even if your quality of life wasn't going to be good. But suppose it's not you with the cancer but a stranger covered by your health-insurance fund. If the insurer provides this man — and everyone else like him — with Sutent, your premiums will increase. Do you still think the drug is a good value? Suppose the treatment cost a million dollars. Would it be worth it then? Ten million? Is there any limit to how much you would want your insurer to pay for a drug that adds six months to someone's life? If there is any point at which you say, "No, an extra six months isn't worth that much," then you think that health care should be rationed.
In the current U.S. debate over health care reform, "rationing" has become a dirty word. Meeting last month with five governors, President Obama urged them to avoid using the term, apparently for fear of evoking the hostile response that sank the Clintons' attempt to achieve reform. In a Wall Street Journal op-ed published at the end of last year with the headline "Obama Will Ration Your Health Care," Sally Pipes, C.E.O. of the conservative Pacific Research Institute, described how in Britain the national health service does not pay for drugs that are regarded as not offering good value for money, and added, "Americans will not put up with such limits, nor will our elected representatives." And the Democratic chair of the Senate Finance Committee, Senator Max Baucus, told CNSNews in April, "There is no rationing of health care at all" in the proposed reform.
Remember the joke about the man who asks a woman if she would have sex with him for a million dollars? She reflects for a few moments and then answers that she would. "So," he says, "would you have sex with me for $50?" Indignantly, she exclaims, "What kind of a woman do you think I am?" He replies: "We've already established that. Now we're just haggling about the price." The man's response implies that if a woman will sell herself at any price, she is a prostitute. The way we regard rationing in health care seems to rest on a similar assumption, that it's immoral to apply monetary considerations to saving lives — but is that stance tenable?
Health care is a scarce resource, and all scarce resources are rationed in one way or another. In the United States, most health care is privately financed, and so most rationing is by price: you get what you, or your employer, can afford to insure you for. But our current system of employer-financed health insurance exists only because the federal government encouraged it by making the premiums tax deductible. That is, in effect, a more than $200 billion government subsidy for health care. In the public sector, primarily Medicare, Medicaid and hospital emergency rooms, health care is rationed by long waits, high patient copayment requirements, low payments to doctors that discourage some from serving public patients and limits on payments to hospitals.
The case for explicit health care rationing in the United States starts with the difficulty of thinking of any other way in which we can continue to provide adequate health care to people on Medicaid and Medicare, let alone extend coverage to those who do not now have it. Health-insurance premiums have more than doubled in a decade, rising four times faster than wages. In May, Medicare's trustees warned that the program's biggest fund is heading for insolvency in just eight years. Health care now absorbs about one dollar in every six the nation spends, a figure that far exceeds the share spent by any other nation. According to the Congressional Budget Office, it is on track to double by 2035.
President Obama has said plainly that America's health care system is broken. It is, he has said, by far the most significant driver of America's long-term debt and deficits. It is hard to see how the nation as a whole can remain competitive if in 26 years we are spending nearly a third of what we earn on health care, while other industrialized nations are spending far less but achieving health outcomes as good as, or better than, ours.
Rationing health care means getting value for the billions we are spending by setting limits on which treatments should be paid for from the public purse. If we ration we won't be writing blank checks to pharmaceutical companies for their patented drugs, nor paying for whatever procedures doctors choose to recommend. When public funds subsidize health care or provide it directly, it is crazy not to try to get value for money. The debate over health care reform in the United States should start from the premise that some form of health care rationing is both inescapable and desirable. Then we can ask, What is the best way to do it?
Last year Britain's National Institute for Health and Clinical Excellence gave a preliminary recommendation that the National Health Service should not offer Sutent for advanced kidney cancer. The institute, generally known as NICE, is a government-financed but independently run organization set up to provide national guidance on promoting good health and treating illness. The decision on Sutent did not, at first glance, appear difficult. NICE had set a general limit of £30,000, or about $49,000, on the cost of extending life for a year. Sutent, when used for advanced kidney cancer, cost more than that, and research suggested it offered only about six months extra life. But the British media leapt on the theme of penny-pinching bureaucrats sentencing sick people to death. The issue was then picked up by the U.S. news media and by those lobbying against health care reform in the United States. An article in The New York Times last December featured Bruce Hardy, a kidney-cancer patient whose wife, Joy, said, "It's hard to know that there is something out there that could help but they're saying you can't have it because of cost." Then she asked the classic question: "What price is life?"
Last November, Bloomberg News focused on Jack Rosser, who was 57 at the time and whose doctor had told him that with Sutent he might live long enough to see his 1-year-old daughter, Emma, enter primary school. Rosser's wife, Jenny, is quoted as saying: "It's immoral. They are sentencing him to die." In the conservative monthly The American Spectator, David Catron, a health care consultant, describes Rosser as "one of NICE's many victims" and writes that NICE "regularly hands down death sentences to gravely ill patients." Linking the British system with Democratic proposals for reforming health care in the United States, Catron asked whether we really deserve a health care system in which "soulless bureaucrats arbitrarily put a dollar value on our lives." (In March, NICE issued a final ruling on Sutent. Because of how few patients need the drug and because of special end-of-life considerations, it recommended that the drug be provided by the National Health Service to patients with advanced kidney cancer.)
There's no doubt that it's tough — politically, emotionally and ethically — to make a decision that means that someone will die sooner than they would have if the decision had gone the other way. But if the stories of Bruce Hardy and Jack Rosser lead us to think badly of the British system of rationing health care, we should remind ourselves that the U.S. system also results in people going without life-saving treatment — it just does so less visibly. Pharmaceutical manufacturers often charge much more for drugs in the United States than they charge for the same drugs in Britain, where they know that a higher price would put the drug outside the cost-effectiveness limits set by NICE. American patients, even if they are covered by Medicare or Medicaid, often cannot afford the copayments for drugs. That's rationing too, by ability to pay.
Dr. Art Kellermann, associate dean for public policy at Emory School of Medicine in Atlanta, recently wrote of a woman who came into his emergency room in critical condition because a blood vessel had burst in her brain. She was uninsured and had chosen to buy food for her children instead of spending money on her blood-pressure medicine. In the emergency room, she received excellent high-tech medical care, but by the time she got there, it was too late to save her.
A New York Times report on the high costs of some drugs illustrates the problem. Chuck Stauffer, an Oregon farmer, found that his prescription-drug insurance left him to pay $5,500 for his first 42 days of Temodar, a drug used to treat brain tumors, and $1,700 a month after that. For Medicare patients drug costs can be even higher, because Medicare can require a copayment of 25 percent of the cost of the drug. For Gleevec, a drug that is effective against some forms of leukemia and some gastrointestinal tumors, that one-quarter of the cost can run to $40,000 a year.
In Britain, everyone has health insurance. In the U.S., some 45 million do not, and nor are they entitled to any health care at all, unless they can get themselves to an emergency room. Hospitals are prohibited from turning away anyone who will be endangered by being refused treatment. But even in emergency rooms, people without health insurance may receive less health care than those with insurance. Joseph Doyle, a professor of economics at the Sloan School of Management at M.I.T., studied the records of people in Wisconsin who were injured in severe automobile accidents and had no choice but to go to the hospital. He estimated that those who had no health insurance received 20 percent less care and had a death rate 37 percent higher than those with health insurance. This difference held up even when those without health insurance were compared with those without automobile insurance, and with those on Medicaid — groups with whom they share some characteristics that might affect treatment. The lack of insurance seems to be what caused the greater number of deaths.
When the media feature someone like Bruce Hardy or Jack Rosser, we readily relate to individuals who are harmed by a government agency's decision to limit the cost of health care. But we tend not to hear about — and thus don't identify with — the particular individuals who die in emergency rooms because they have no health insurance. This "identifiable victim" effect, well documented by psychologists, creates a dangerous bias in our thinking. Doyle's figures suggest that if those Wisconsin accident victims without health insurance had received equivalent care to those with it, the additional health care would have cost about $220,000 for each life saved. Those who died were on average around 30 years old and could have been expected to live for at least another 40 years; this means that had they survived their accidents, the cost per extra year of life would have been no more than $5,500 — a small fraction of the $49,000 that NICE recommends the British National Health Service should be ready to pay to give a patient an extra year of life. If the U.S. system spent less on expensive treatments for those who, with or without the drugs, have at most a few months to live, it would be better able to save the lives of more people who, if they get the treatment they need, might live for several decades.
Estimates of the number of U.S. deaths caused annually by the absence of universal health insurance go as high as 20,000. One study concluded that in the age group 55 to 64 alone, more than 13,000 extra deaths a year may be attributed to the lack of insurance coverage. But the estimates vary because Americans without health insurance are more likely, for example, to smoke than Americans with health insurance, and sorting out the role that the lack of insurance plays is difficult. Richard Kronick, a professor at the School of Medicine at the University of California, San Diego, cautiously concludes from his own study that there is little evidence to suggest that extending health insurance to all Americans would have a large effect on the number of deaths in the United States. That doesn't mean that it wouldn't; we simply don't know if it would.
In any case, it isn't only uninsured Americans who can't afford treatment. President Obama has spoken about his mother, who died from ovarian cancer in 1995. The president said that in the last weeks of her life, his mother "was spending too much time worrying about whether her health insurance would cover her bills" — an experience, the president went on to say, that his mother shared with millions of other Americans. It is also an experience more common in the United States than in other developed countries. A recent Commonwealth Fund study led by Cathy Schoen and Robin Osborn surveyed adults with chronic illness in Australia, Canada, France, Germany, the Netherlands, New Zealand, the United Kingdom and the United States. Far more Americans reported forgoing health care because of cost. More than half (54 percent) reported not filling a prescription, not visiting a doctor when sick or not getting recommended care. In comparison, in the United Kingdom the figure was 13 percent, and in the Netherlands, only 7 percent. Even among Americans with insurance, 43 percent reported that cost was a problem that had limited the treatment they received. According to a 2007 study led by David Himmelstein, more than 60 percent of all bankruptcies are related to illness, with many of these specifically caused by medical bills, even among those who have health insurance. In Canada the incidence of bankruptcy related to illness is much lower.
When a Washington Post journalist asked Daniel Zemel, a Washington rabbi, what he thought about federal agencies putting a dollar value on human life, the rabbi cited a Jewish teaching explaining that if you put one human life on one side of a scale, and you put the rest of the world on the other side, the scale is balanced equally. Perhaps that is how those who resist health care rationing think. But we already put a dollar value on human life. If the Department of Transportation, for example, followed rabbinical teachings it would exhaust its entire budget on road safety. Fortunately the department sets a limit on how much it is willing to pay to save one human life. In 2008 that limit was $5.8 million. Other government agencies do the same. Last year the Consumer Product Safety Commission considered a proposal to make mattresses less likely to catch fire. Information from the industry suggested that the new standard would cost $343 million to implement, but the Consumer Product Safety Commission calculated that it would save 270 lives a year — and since it valued a human life at around $5 million, that made the new standard a good value. If we are going to have consumer-safety regulation at all, we need some idea of how much safety is worth buying. Like health care bureaucrats, consumer-safety bureaucrats sometimes decide that saving a human life is not worth the expense. Twenty years ago, the National Research Council, an arm of the National Academy of Sciences, examined a proposal for installing seat belts in all school buses. It estimated that doing so would save, on average, one life per year, at a cost of $40 million. After that, support for the proposal faded away. So why is it that those who accept that we put a price on life when it comes to consumer safety refuse to accept it when it comes to health care?
Of course, it's one thing to accept that there's a limit to how much we should spend to save a human life, and another to set that limit. The dollar value that bureaucrats place on a generic human life is intended to reflect social values, as revealed in our behavior. It is the answer to the question "How much are you willing to pay to save your life?" — except that, of course, if you asked that question of people who were facing death, they would be prepared to pay almost anything to save their lives. So instead, economists note how much people are prepared to pay to reduce the risk that they will die. How much will people pay for air bags in a car, for instance? Once you know how much they will pay for a specified reduction in risk, you multiply the amount that people are willing to pay by how much the risk has been reduced, and then you know, or so the theory goes, what value people place on their lives. Suppose that there is a 1 in 100,000 chance that an air bag in my car will save my life, and that I would pay $50 — but no more than that — for an air bag. Then it looks as if I value my life at $50 x 100,000, or $5 million.
The theory sounds good, but in practice it has problems. We are not good at taking account of differences between very small risks, so if we are asked how much we would pay to reduce a risk of dying from 1 in 1,000,000 to 1 in 10,000,000, we may give the same answer as we would if asked how much we would pay to reduce the risk from 1 in 500,000 to 1 in 10,000,000. Hence multiplying what we would pay to reduce the risk of death by the reduction in risk lends an apparent mathematical precision to the outcome of the calculation — the supposed value of a human life — that our intuitive responses to the questions cannot support. Nevertheless this approach to setting a value on a human life is at least closer to what we really believe — and to what we should believe — than dramatic pronouncements about the infinite value of every human life, or the suggestion that we cannot distinguish between the value of a single human life and the value of a million human lives, or even of the rest of the world. Though such feel-good claims may have some symbolic value in particular circumstances, to take them seriously and apply them — for instance, by leaving it to chance whether we save one life or a billion — would be deeply unethical.
Governments implicitly place a dollar value on a human life when they decide how much is to be spent on health care programs and how much on other public goods that are not directed toward saving lives. The task of health care bureaucrats is then to get the best value for the resources they have been allocated. It is the familiar comparative exercise of getting the most bang for your buck. Sometimes that can be relatively easy to decide. If two drugs offer the same benefits and have similar risks of side effects, but one is much more expensive than the other, only the cheaper one should be provided by the public health care program. That the benefits and the risks of side effects are similar is a scientific matter for experts to decide after calling for submissions and examining them. That is the bread-and-butter work of units like NICE. But the benefits may vary in ways that defy straightforward comparison. We need a common unit for measuring the goods achieved by health care. Since we are talking about comparing different goods, the choice of unit is not merely a scientific or economic question but an ethical one.
As a first take, we might say that the good achieved by health care is the number of lives saved. But that is too crude. The death of a teenager is a greater tragedy than the death of an 85-year-old, and this should be reflected in our priorities. We can accommodate that difference by calculating the number of life-years saved, rather than simply the number of lives saved. If a teenager can be expected to live another 70 years, saving her life counts as a gain of 70 life-years, whereas if a person of 85 can be expected to live another 5 years, then saving the 85-year-old will count as a gain of only 5 life-years. That suggests that saving one teenager is equivalent to saving 14 85-year-olds. These are, of course, generic teenagers and generic 85-year-olds. It's easy to say, "What if the teenager is a violent criminal and the 85-year-old is still working productively?" But just as emergency rooms should leave criminal justice to the courts and treat assailants and victims alike, so decisions about the allocation of health care resources should be kept separate from judgments about the moral character or social value of individuals.
Health care does more than save lives: it also reduces pain and suffering. How can we compare saving a person's life with, say, making it possible for someone who was confined to bed to return to an active life? We can elicit people's values on that too. One common method is to describe medical conditions to people — let's say being a quadriplegic — and tell them that they can choose between 10 years in that condition or some smaller number of years without it. If most would prefer, say, 10 years as a quadriplegic to 4 years of nondisabled life, but would choose 6 years of nondisabled life over 10 with quadriplegia, but have difficulty deciding between 5 years of nondisabled life or 10 years with quadriplegia, then they are, in effect, assessing life with quadriplegia as half as good as nondisabled life. (These are hypothetical figures, chosen to keep the math simple, and not based on any actual surveys.) If that judgment represents a rough average across the population, we might conclude that restoring to nondisabled life two people who would otherwise be quadriplegics is equivalent in value to saving the life of one person, provided the life expectancies of all involved are similar.
This is the basis of the quality-adjusted life-year, or QALY, a unit designed to enable us to compare the benefits achieved by different forms of health care. The QALY has been used by economists working in health care for more than 30 years to compare the cost-effectiveness of a wide variety of medical procedures and, in some countries, as part of the process of deciding which medical treatments will be paid for with public money. If a reformed U.S. health care system explicitly accepted rationing, as I have argued it should, QALYs could play a similar role in the U.S.
Some will object that this discriminates against people with disabilities. If we return to the hypothetical assumption that a year with quadriplegia is valued at only half as much as a year without it, then a treatment that extends the lives of people without disabilities will be seen as providing twice the value of one that extends, for a similar period, the lives of quadriplegics. That clashes with the idea that all human lives are of equal value. The problem, however, does not lie with the concept of the quality-adjusted life-year, but with the judgment that, if faced with 10 years as a quadriplegic, one would prefer a shorter lifespan without a disability. Disability advocates might argue that such judgments, made by people without disabilities, merely reflect the ignorance and prejudice of people without disabilities when they think about people with disabilities. We should, they will very reasonably say, ask quadriplegics themselves to evaluate life with quadriplegia. If we do that, and we find that quadriplegics would not give up even one year of life as a quadriplegic in order to have their disability cured, then the QALY method does not justify giving preference to procedures that extend the lives of people without disabilities over procedures that extend the lives of people with disabilities.
This method of preserving our belief that everyone has an equal right to life is, however, a double-edged sword. If life with quadriplegia is as good as life without it, there is no health benefit to be gained by curing it. That implication, no doubt, would have been vigorously rejected by someone like Christopher Reeve, who, after being paralyzed in an accident, campaigned for more research into ways of overcoming spinal-cord injuries. Disability advocates, it seems, are forced to choose between insisting that extending their lives is just as important as extending the lives of people without disabilities, and seeking public support for research into a cure for their condition.
The QALY tells us to do what brings about the greatest health benefit, irrespective of where that benefit falls. Usually, for a given quantity of resources, we will do more good if we help those who are worst off, because they have the greatest unmet needs. But occasionally some conditions will be both very severe and very expensive to treat. A QALY approach may then lead us to give priority to helping others who are not so badly off and whose conditions are less expensive to treat. I don't find it unfair to give the same weight to the interests of those who are well off as we give to those who are much worse off, but if there is a social consensus that we should give priority to those who are worse off, we can modify the QALY approach so that it gives greater weight to benefits that accrue to those who are, on the QALY scale, worse off than others.
The QALY approach does not even try to measure the benefits that health care brings in addition to the improvement in health itself. Emotionally, we feel that the fact that Jack Rosser is the father of a young child makes a difference to the importance of extending his life, but his parental status is irrelevant to a QALY assessment of the health care gains that Sutent would bring him. Whether decisions about allocating health care resources should take such personal circumstances into account isn't easy to decide. Not to do so makes the standard inflexible, but taking personal factors into account increases the scope for subjective — and prejudiced — judgments.
The QALY is not a perfect measure of the good obtained by health care, but its defenders can support it in the same way that Winston Churchill defended democracy as a form of government: it is the worst method of allocating health care, except for all the others. If it isn't possible to provide everyone with all beneficial treatments, what better way do we have of deciding what treatments people should get than by comparing the QALYs gained with the expense of the treatments?
Will Americans allow their government, either directly or through an independent agency like NICE, to decide which treatments are sufficiently cost-effective to be provided at public expense and which are not? They might, under two conditions: first, that the option of private health insurance remains available, and second, that they are able to see, in their own pocket, the full cost of not rationing health care.
Rationing public health care limits free choice if private health insurance is prohibited. But many countries combine free national health insurance with optional private insurance. Australia, where I've spent most of my life and raised a family, is one. The U.S. could do something similar. This would mean extending Medicare to the entire population, irrespective of age, but without Medicare's current policy that allows doctors wide latitude in prescribing treatments for eligible patients. Instead, Medicare for All, as we might call it, should refuse to pay where the cost per QALY is extremely high. (On the other hand, Medicare for All would not require more than a token copayment for drugs that are cost-effective.) The extension of Medicare could be financed by a small income-tax levy, for those who pay income tax — in Australia the levy is 1.5 percent of taxable income. (There's an extra 1 percent surcharge for those with high incomes and no private insurance. Those who earn too little to pay income tax would be carried at no cost to themselves.) Those who want to be sure of receiving every treatment that their own privately chosen physicians recommend, regardless of cost, would be free to opt out of Medicare for All as long as they can demonstrate that they have sufficient private health insurance to avoid becoming a burden on the community if they fall ill. Alternatively, they might remain in Medicare for All but take out supplementary insurance for health care that Medicare for All does not cover. Every American will have a right to a good standard of health care, but no one will have a right to unrationed health care. Those who opt for unrationed health care will know exactly how much it costs them.
One final comment. It is common for opponents of health care rationing to point to Canada and Britain as examples of where we might end up if we get "socialized medicine." On a blog on Fox News earlier this year, the conservative writer John Lott wrote, "Americans should ask Canadians and Brits — people who have long suffered from rationing — how happy they are with central government decisions on eliminating 'unnecessary' health care." There is no particular reason that the United States should copy the British or Canadian forms of universal coverage, rather than one of the different arrangements that have developed in other industrialized nations, some of which may be better. But as it happens, last year the Gallup organization did ask Canadians and Brits, and people in many different countries, if they have confidence in "health care or medical systems" in their country. In Canada, 73 percent answered this question affirmatively. Coincidentally, an identical percentage of Britons gave the same answer. In the United States, despite spending much more, per person, on health care, the figure was only 56 percent.
Peter Singer is professor of bioethics at Princeton University. He is also laureate professor at the University of Melbourne, in Australia. His most recent book is "The Life You Can Save: Acting Now to End World Poverty."
This article has been revised to reflect the following correction:
Correction: July 18, 2009
An article in The Times Magazine this weekend about the argument for rationing health care in the United States misstates the number of years it would take under the current system for the country to spend nearly a third of what it earns on health care. It is 26 years from now, or 2035, not 15 years.
Why We Must Ration Health Care - NYTimes.com (18 July 2009)
http://www.nytimes.com/2009/07/19/magazine/19healthcare-t.html?_r=1&em=&pagewanted=print
http://snipurl.com/nh5eh
Why We Must Ration Health Care By PETER SINGER
You have advanced kidney cancer. It will kill you, probably in the next year or two. A drug called Sutent slows the spread of the cancer and may give you an extra six months, but at a cost of $54,000. Is a few more months worth that much?
If you can afford it, you probably would pay that much, or more, to live longer, even if your quality of life wasn't going to be good. But suppose it's not you with the cancer but a stranger covered by your health-insurance fund. If the insurer provides this man — and everyone else like him — with Sutent, your premiums will increase. Do you still think the drug is a good value? Suppose the treatment cost a million dollars. Would it be worth it then? Ten million? Is there any limit to how much you would want your insurer to pay for a drug that adds six months to someone's life? If there is any point at which you say, "No, an extra six months isn't worth that much," then you think that health care should be rationed.
In the current U.S. debate over health care reform, "rationing" has become a dirty word. Meeting last month with five governors, President Obama urged them to avoid using the term, apparently for fear of evoking the hostile response that sank the Clintons' attempt to achieve reform. In a Wall Street Journal op-ed published at the end of last year with the headline "Obama Will Ration Your Health Care," Sally Pipes, C.E.O. of the conservative Pacific Research Institute, described how in Britain the national health service does not pay for drugs that are regarded as not offering good value for money, and added, "Americans will not put up with such limits, nor will our elected representatives." And the Democratic chair of the Senate Finance Committee, Senator Max Baucus, told CNSNews in April, "There is no rationing of health care at all" in the proposed reform.
Remember the joke about the man who asks a woman if she would have sex with him for a million dollars? She reflects for a few moments and then answers that she would. "So," he says, "would you have sex with me for $50?" Indignantly, she exclaims, "What kind of a woman do you think I am?" He replies: "We've already established that. Now we're just haggling about the price." The man's response implies that if a woman will sell herself at any price, she is a prostitute. The way we regard rationing in health care seems to rest on a similar assumption, that it's immoral to apply monetary considerations to saving lives — but is that stance tenable?
Health care is a scarce resource, and all scarce resources are rationed in one way or another. In the United States, most health care is privately financed, and so most rationing is by price: you get what you, or your employer, can afford to insure you for. But our current system of employer-financed health insurance exists only because the federal government encouraged it by making the premiums tax deductible. That is, in effect, a more than $200 billion government subsidy for health care. In the public sector, primarily Medicare, Medicaid and hospital emergency rooms, health care is rationed by long waits, high patient copayment requirements, low payments to doctors that discourage some from serving public patients and limits on payments to hospitals.
The case for explicit health care rationing in the United States starts with the difficulty of thinking of any other way in which we can continue to provide adequate health care to people on Medicaid and Medicare, let alone extend coverage to those who do not now have it. Health-insurance premiums have more than doubled in a decade, rising four times faster than wages. In May, Medicare's trustees warned that the program's biggest fund is heading for insolvency in just eight years. Health care now absorbs about one dollar in every six the nation spends, a figure that far exceeds the share spent by any other nation. According to the Congressional Budget Office, it is on track to double by 2035.
President Obama has said plainly that America's health care system is broken. It is, he has said, by far the most significant driver of America's long-term debt and deficits. It is hard to see how the nation as a whole can remain competitive if in 26 years we are spending nearly a third of what we earn on health care, while other industrialized nations are spending far less but achieving health outcomes as good as, or better than, ours.
Rationing health care means getting value for the billions we are spending by setting limits on which treatments should be paid for from the public purse. If we ration we won't be writing blank checks to pharmaceutical companies for their patented drugs, nor paying for whatever procedures doctors choose to recommend. When public funds subsidize health care or provide it directly, it is crazy not to try to get value for money. The debate over health care reform in the United States should start from the premise that some form of health care rationing is both inescapable and desirable. Then we can ask, What is the best way to do it?
Last year Britain's National Institute for Health and Clinical Excellence gave a preliminary recommendation that the National Health Service should not offer Sutent for advanced kidney cancer. The institute, generally known as NICE, is a government-financed but independently run organization set up to provide national guidance on promoting good health and treating illness. The decision on Sutent did not, at first glance, appear difficult. NICE had set a general limit of £30,000, or about $49,000, on the cost of extending life for a year. Sutent, when used for advanced kidney cancer, cost more than that, and research suggested it offered only about six months extra life. But the British media leapt on the theme of penny-pinching bureaucrats sentencing sick people to death. The issue was then picked up by the U.S. news media and by those lobbying against health care reform in the United States. An article in The New York Times last December featured Bruce Hardy, a kidney-cancer patient whose wife, Joy, said, "It's hard to know that there is something out there that could help but they're saying you can't have it because of cost." Then she asked the classic question: "What price is life?"
Last November, Bloomberg News focused on Jack Rosser, who was 57 at the time and whose doctor had told him that with Sutent he might live long enough to see his 1-year-old daughter, Emma, enter primary school. Rosser's wife, Jenny, is quoted as saying: "It's immoral. They are sentencing him to die." In the conservative monthly The American Spectator, David Catron, a health care consultant, describes Rosser as "one of NICE's many victims" and writes that NICE "regularly hands down death sentences to gravely ill patients." Linking the British system with Democratic proposals for reforming health care in the United States, Catron asked whether we really deserve a health care system in which "soulless bureaucrats arbitrarily put a dollar value on our lives." (In March, NICE issued a final ruling on Sutent. Because of how few patients need the drug and because of special end-of-life considerations, it recommended that the drug be provided by the National Health Service to patients with advanced kidney cancer.)
There's no doubt that it's tough — politically, emotionally and ethically — to make a decision that means that someone will die sooner than they would have if the decision had gone the other way. But if the stories of Bruce Hardy and Jack Rosser lead us to think badly of the British system of rationing health care, we should remind ourselves that the U.S. system also results in people going without life-saving treatment — it just does so less visibly. Pharmaceutical manufacturers often charge much more for drugs in the United States than they charge for the same drugs in Britain, where they know that a higher price would put the drug outside the cost-effectiveness limits set by NICE. American patients, even if they are covered by Medicare or Medicaid, often cannot afford the copayments for drugs. That's rationing too, by ability to pay.
Dr. Art Kellermann, associate dean for public policy at Emory School of Medicine in Atlanta, recently wrote of a woman who came into his emergency room in critical condition because a blood vessel had burst in her brain. She was uninsured and had chosen to buy food for her children instead of spending money on her blood-pressure medicine. In the emergency room, she received excellent high-tech medical care, but by the time she got there, it was too late to save her.
A New York Times report on the high costs of some drugs illustrates the problem. Chuck Stauffer, an Oregon farmer, found that his prescription-drug insurance left him to pay $5,500 for his first 42 days of Temodar, a drug used to treat brain tumors, and $1,700 a month after that. For Medicare patients drug costs can be even higher, because Medicare can require a copayment of 25 percent of the cost of the drug. For Gleevec, a drug that is effective against some forms of leukemia and some gastrointestinal tumors, that one-quarter of the cost can run to $40,000 a year.
In Britain, everyone has health insurance. In the U.S., some 45 million do not, and nor are they entitled to any health care at all, unless they can get themselves to an emergency room. Hospitals are prohibited from turning away anyone who will be endangered by being refused treatment. But even in emergency rooms, people without health insurance may receive less health care than those with insurance. Joseph Doyle, a professor of economics at the Sloan School of Management at M.I.T., studied the records of people in Wisconsin who were injured in severe automobile accidents and had no choice but to go to the hospital. He estimated that those who had no health insurance received 20 percent less care and had a death rate 37 percent higher than those with health insurance. This difference held up even when those without health insurance were compared with those without automobile insurance, and with those on Medicaid — groups with whom they share some characteristics that might affect treatment. The lack of insurance seems to be what caused the greater number of deaths.
When the media feature someone like Bruce Hardy or Jack Rosser, we readily relate to individuals who are harmed by a government agency's decision to limit the cost of health care. But we tend not to hear about — and thus don't identify with — the particular individuals who die in emergency rooms because they have no health insurance. This "identifiable victim" effect, well documented by psychologists, creates a dangerous bias in our thinking. Doyle's figures suggest that if those Wisconsin accident victims without health insurance had received equivalent care to those with it, the additional health care would have cost about $220,000 for each life saved. Those who died were on average around 30 years old and could have been expected to live for at least another 40 years; this means that had they survived their accidents, the cost per extra year of life would have been no more than $5,500 — a small fraction of the $49,000 that NICE recommends the British National Health Service should be ready to pay to give a patient an extra year of life. If the U.S. system spent less on expensive treatments for those who, with or without the drugs, have at most a few months to live, it would be better able to save the lives of more people who, if they get the treatment they need, might live for several decades.
Estimates of the number of U.S. deaths caused annually by the absence of universal health insurance go as high as 20,000. One study concluded that in the age group 55 to 64 alone, more than 13,000 extra deaths a year may be attributed to the lack of insurance coverage. But the estimates vary because Americans without health insurance are more likely, for example, to smoke than Americans with health insurance, and sorting out the role that the lack of insurance plays is difficult. Richard Kronick, a professor at the School of Medicine at the University of California, San Diego, cautiously concludes from his own study that there is little evidence to suggest that extending health insurance to all Americans would have a large effect on the number of deaths in the United States. That doesn't mean that it wouldn't; we simply don't know if it would.
In any case, it isn't only uninsured Americans who can't afford treatment. President Obama has spoken about his mother, who died from ovarian cancer in 1995. The president said that in the last weeks of her life, his mother "was spending too much time worrying about whether her health insurance would cover her bills" — an experience, the president went on to say, that his mother shared with millions of other Americans. It is also an experience more common in the United States than in other developed countries. A recent Commonwealth Fund study led by Cathy Schoen and Robin Osborn surveyed adults with chronic illness in Australia, Canada, France, Germany, the Netherlands, New Zealand, the United Kingdom and the United States. Far more Americans reported forgoing health care because of cost. More than half (54 percent) reported not filling a prescription, not visiting a doctor when sick or not getting recommended care. In comparison, in the United Kingdom the figure was 13 percent, and in the Netherlands, only 7 percent. Even among Americans with insurance, 43 percent reported that cost was a problem that had limited the treatment they received. According to a 2007 study led by David Himmelstein, more than 60 percent of all bankruptcies are related to illness, with many of these specifically caused by medical bills, even among those who have health insurance. In Canada the incidence of bankruptcy related to illness is much lower.
When a Washington Post journalist asked Daniel Zemel, a Washington rabbi, what he thought about federal agencies putting a dollar value on human life, the rabbi cited a Jewish teaching explaining that if you put one human life on one side of a scale, and you put the rest of the world on the other side, the scale is balanced equally. Perhaps that is how those who resist health care rationing think. But we already put a dollar value on human life. If the Department of Transportation, for example, followed rabbinical teachings it would exhaust its entire budget on road safety. Fortunately the department sets a limit on how much it is willing to pay to save one human life. In 2008 that limit was $5.8 million. Other government agencies do the same. Last year the Consumer Product Safety Commission considered a proposal to make mattresses less likely to catch fire. Information from the industry suggested that the new standard would cost $343 million to implement, but the Consumer Product Safety Commission calculated that it would save 270 lives a year — and since it valued a human life at around $5 million, that made the new standard a good value. If we are going to have consumer-safety regulation at all, we need some idea of how much safety is worth buying. Like health care bureaucrats, consumer-safety bureaucrats sometimes decide that saving a human life is not worth the expense. Twenty years ago, the National Research Council, an arm of the National Academy of Sciences, examined a proposal for installing seat belts in all school buses. It estimated that doing so would save, on average, one life per year, at a cost of $40 million. After that, support for the proposal faded away. So why is it that those who accept that we put a price on life when it comes to consumer safety refuse to accept it when it comes to health care?
Of course, it's one thing to accept that there's a limit to how much we should spend to save a human life, and another to set that limit. The dollar value that bureaucrats place on a generic human life is intended to reflect social values, as revealed in our behavior. It is the answer to the question "How much are you willing to pay to save your life?" — except that, of course, if you asked that question of people who were facing death, they would be prepared to pay almost anything to save their lives. So instead, economists note how much people are prepared to pay to reduce the risk that they will die. How much will people pay for air bags in a car, for instance? Once you know how much they will pay for a specified reduction in risk, you multiply the amount that people are willing to pay by how much the risk has been reduced, and then you know, or so the theory goes, what value people place on their lives. Suppose that there is a 1 in 100,000 chance that an air bag in my car will save my life, and that I would pay $50 — but no more than that — for an air bag. Then it looks as if I value my life at $50 x 100,000, or $5 million.
The theory sounds good, but in practice it has problems. We are not good at taking account of differences between very small risks, so if we are asked how much we would pay to reduce a risk of dying from 1 in 1,000,000 to 1 in 10,000,000, we may give the same answer as we would if asked how much we would pay to reduce the risk from 1 in 500,000 to 1 in 10,000,000. Hence multiplying what we would pay to reduce the risk of death by the reduction in risk lends an apparent mathematical precision to the outcome of the calculation — the supposed value of a human life — that our intuitive responses to the questions cannot support. Nevertheless this approach to setting a value on a human life is at least closer to what we really believe — and to what we should believe — than dramatic pronouncements about the infinite value of every human life, or the suggestion that we cannot distinguish between the value of a single human life and the value of a million human lives, or even of the rest of the world. Though such feel-good claims may have some symbolic value in particular circumstances, to take them seriously and apply them — for instance, by leaving it to chance whether we save one life or a billion — would be deeply unethical.
Governments implicitly place a dollar value on a human life when they decide how much is to be spent on health care programs and how much on other public goods that are not directed toward saving lives. The task of health care bureaucrats is then to get the best value for the resources they have been allocated. It is the familiar comparative exercise of getting the most bang for your buck. Sometimes that can be relatively easy to decide. If two drugs offer the same benefits and have similar risks of side effects, but one is much more expensive than the other, only the cheaper one should be provided by the public health care program. That the benefits and the risks of side effects are similar is a scientific matter for experts to decide after calling for submissions and examining them. That is the bread-and-butter work of units like NICE. But the benefits may vary in ways that defy straightforward comparison. We need a common unit for measuring the goods achieved by health care. Since we are talking about comparing different goods, the choice of unit is not merely a scientific or economic question but an ethical one.
As a first take, we might say that the good achieved by health care is the number of lives saved. But that is too crude. The death of a teenager is a greater tragedy than the death of an 85-year-old, and this should be reflected in our priorities. We can accommodate that difference by calculating the number of life-years saved, rather than simply the number of lives saved. If a teenager can be expected to live another 70 years, saving her life counts as a gain of 70 life-years, whereas if a person of 85 can be expected to live another 5 years, then saving the 85-year-old will count as a gain of only 5 life-years. That suggests that saving one teenager is equivalent to saving 14 85-year-olds. These are, of course, generic teenagers and generic 85-year-olds. It's easy to say, "What if the teenager is a violent criminal and the 85-year-old is still working productively?" But just as emergency rooms should leave criminal justice to the courts and treat assailants and victims alike, so decisions about the allocation of health care resources should be kept separate from judgments about the moral character or social value of individuals.
Health care does more than save lives: it also reduces pain and suffering. How can we compare saving a person's life with, say, making it possible for someone who was confined to bed to return to an active life? We can elicit people's values on that too. One common method is to describe medical conditions to people — let's say being a quadriplegic — and tell them that they can choose between 10 years in that condition or some smaller number of years without it. If most would prefer, say, 10 years as a quadriplegic to 4 years of nondisabled life, but would choose 6 years of nondisabled life over 10 with quadriplegia, but have difficulty deciding between 5 years of nondisabled life or 10 years with quadriplegia, then they are, in effect, assessing life with quadriplegia as half as good as nondisabled life. (These are hypothetical figures, chosen to keep the math simple, and not based on any actual surveys.) If that judgment represents a rough average across the population, we might conclude that restoring to nondisabled life two people who would otherwise be quadriplegics is equivalent in value to saving the life of one person, provided the life expectancies of all involved are similar.
This is the basis of the quality-adjusted life-year, or QALY, a unit designed to enable us to compare the benefits achieved by different forms of health care. The QALY has been used by economists working in health care for more than 30 years to compare the cost-effectiveness of a wide variety of medical procedures and, in some countries, as part of the process of deciding which medical treatments will be paid for with public money. If a reformed U.S. health care system explicitly accepted rationing, as I have argued it should, QALYs could play a similar role in the U.S.
Some will object that this discriminates against people with disabilities. If we return to the hypothetical assumption that a year with quadriplegia is valued at only half as much as a year without it, then a treatment that extends the lives of people without disabilities will be seen as providing twice the value of one that extends, for a similar period, the lives of quadriplegics. That clashes with the idea that all human lives are of equal value. The problem, however, does not lie with the concept of the quality-adjusted life-year, but with the judgment that, if faced with 10 years as a quadriplegic, one would prefer a shorter lifespan without a disability. Disability advocates might argue that such judgments, made by people without disabilities, merely reflect the ignorance and prejudice of people without disabilities when they think about people with disabilities. We should, they will very reasonably say, ask quadriplegics themselves to evaluate life with quadriplegia. If we do that, and we find that quadriplegics would not give up even one year of life as a quadriplegic in order to have their disability cured, then the QALY method does not justify giving preference to procedures that extend the lives of people without disabilities over procedures that extend the lives of people with disabilities.
This method of preserving our belief that everyone has an equal right to life is, however, a double-edged sword. If life with quadriplegia is as good as life without it, there is no health benefit to be gained by curing it. That implication, no doubt, would have been vigorously rejected by someone like Christopher Reeve, who, after being paralyzed in an accident, campaigned for more research into ways of overcoming spinal-cord injuries. Disability advocates, it seems, are forced to choose between insisting that extending their lives is just as important as extending the lives of people without disabilities, and seeking public support for research into a cure for their condition.
The QALY tells us to do what brings about the greatest health benefit, irrespective of where that benefit falls. Usually, for a given quantity of resources, we will do more good if we help those who are worst off, because they have the greatest unmet needs. But occasionally some conditions will be both very severe and very expensive to treat. A QALY approach may then lead us to give priority to helping others who are not so badly off and whose conditions are less expensive to treat. I don't find it unfair to give the same weight to the interests of those who are well off as we give to those who are much worse off, but if there is a social consensus that we should give priority to those who are worse off, we can modify the QALY approach so that it gives greater weight to benefits that accrue to those who are, on the QALY scale, worse off than others.
The QALY approach does not even try to measure the benefits that health care brings in addition to the improvement in health itself. Emotionally, we feel that the fact that Jack Rosser is the father of a young child makes a difference to the importance of extending his life, but his parental status is irrelevant to a QALY assessment of the health care gains that Sutent would bring him. Whether decisions about allocating health care resources should take such personal circumstances into account isn't easy to decide. Not to do so makes the standard inflexible, but taking personal factors into account increases the scope for subjective — and prejudiced — judgments.
The QALY is not a perfect measure of the good obtained by health care, but its defenders can support it in the same way that Winston Churchill defended democracy as a form of government: it is the worst method of allocating health care, except for all the others. If it isn't possible to provide everyone with all beneficial treatments, what better way do we have of deciding what treatments people should get than by comparing the QALYs gained with the expense of the treatments?
Will Americans allow their government, either directly or through an independent agency like NICE, to decide which treatments are sufficiently cost-effective to be provided at public expense and which are not? They might, under two conditions: first, that the option of private health insurance remains available, and second, that they are able to see, in their own pocket, the full cost of not rationing health care.
Rationing public health care limits free choice if private health insurance is prohibited. But many countries combine free national health insurance with optional private insurance. Australia, where I've spent most of my life and raised a family, is one. The U.S. could do something similar. This would mean extending Medicare to the entire population, irrespective of age, but without Medicare's current policy that allows doctors wide latitude in prescribing treatments for eligible patients. Instead, Medicare for All, as we might call it, should refuse to pay where the cost per QALY is extremely high. (On the other hand, Medicare for All would not require more than a token copayment for drugs that are cost-effective.) The extension of Medicare could be financed by a small income-tax levy, for those who pay income tax — in Australia the levy is 1.5 percent of taxable income. (There's an extra 1 percent surcharge for those with high incomes and no private insurance. Those who earn too little to pay income tax would be carried at no cost to themselves.) Those who want to be sure of receiving every treatment that their own privately chosen physicians recommend, regardless of cost, would be free to opt out of Medicare for All as long as they can demonstrate that they have sufficient private health insurance to avoid becoming a burden on the community if they fall ill. Alternatively, they might remain in Medicare for All but take out supplementary insurance for health care that Medicare for All does not cover. Every American will have a right to a good standard of health care, but no one will have a right to unrationed health care. Those who opt for unrationed health care will know exactly how much it costs them.
One final comment. It is common for opponents of health care rationing to point to Canada and Britain as examples of where we might end up if we get "socialized medicine." On a blog on Fox News earlier this year, the conservative writer John Lott wrote, "Americans should ask Canadians and Brits — people who have long suffered from rationing — how happy they are with central government decisions on eliminating 'unnecessary' health care." There is no particular reason that the United States should copy the British or Canadian forms of universal coverage, rather than one of the different arrangements that have developed in other industrialized nations, some of which may be better. But as it happens, last year the Gallup organization did ask Canadians and Brits, and people in many different countries, if they have confidence in "health care or medical systems" in their country. In Canada, 73 percent answered this question affirmatively. Coincidentally, an identical percentage of Britons gave the same answer. In the United States, despite spending much more, per person, on health care, the figure was only 56 percent.
Peter Singer is professor of bioethics at Princeton University. He is also laureate professor at the University of Melbourne, in Australia. His most recent book is "The Life You Can Save: Acting Now to End World Poverty."
This article has been revised to reflect the following correction:
Correction: July 18, 2009
An article in The Times Magazine this weekend about the argument for rationing health care in the United States misstates the number of years it would take under the current system for the country to spend nearly a third of what it earns on health care. It is 26 years from now, or 2035, not 15 years.
Why We Must Ration Health Care - NYTimes.com (18 July 2009)
http://www.nytimes.com/2009/07/19/magazine/19healthcare-t.html?_r=1&em=&pagewanted=print
http://snipurl.com/nh5eh
Saturday, September 13, 2008
Defibrillators Are Lifesaver, but Risks Give Pause By BARNABY J. FEDER
September 13, 2008
Defibrillators Are Lifesaver, but Risks Give Pause
By BARNABY J. FEDER
The implanted defibrillator, a device that can automatically shock an erratically beating heart back to a normal rhythm, has been proved to save lives. Hence its nickname: an emergency room in the chest. Major medical groups have recommended that more patients receive the devices.
But in the last two years the number of patients receiving defibrillators has actually declined, as more doctors and patients decide the risks and uncertainties the devices pose may outweigh their potential benefits.
This trend — the first decline since implanted defibrillators were introduced in 1985 — has spotlighted a shortcoming that health experts have struggled with for years. Simply put, there is no adequate tool or test to predict which of the heart patients who might seem good candidates to get the expensive devices are the ones most likely to ever need their life-saving shock.
Defibrillators have undoubtedly saved the lives of tens of thousands of Americans. That is why insurers still typically pay for the devices and the surgical procedure to implant them, which can top $50,000 for each patient.
What makes many doctors and patients increasingly wary, though, is a string of highly publicized recalls in recent years, along with mounting evidence suggesting that a vast majority of people who get a defibrillator never need it.
Industry estimates and medical studies indicate that defibrillators have saved the lives of 10 percent of the more than 600,000 people in this country who have received them, at most. While survivors would no doubt take those odds, 9 of 10 people who get defibrillators receive no medical benefit. One big long-term medical study indicated the odds of a defibrillator saving a patient’s life might be even slimmer — about 1 in 14, over the five-year period studied.
The problem that defibrillators pose is in some ways singular among medical technologies. For devices like artificial knees, which improve lives but do not save them, few people would settle for only a 1 in 10 chance of success. For a potentially life-saving cancer drug, a patient might grasp at even much slimmer odds. Where defibrillators differ is that they are only a powerful standby — ready to intervene if necessary, but unlikely ever to be called into service.
If defibrillators were simply $50,000 life insurance policies, the relatively low rate of payoff might not matter much. But the long-shot statistics are significant to people who must weigh the risks of infection and malfunction after they have an electronic device anchored inside their hearts and its wires threaded through their arteries.
The slim odds also have large implications for the United States health care bill, adding billions of dollars annually to Medicare spending and to insurance payments. Dr. Larry A. Chinitz, director of the Heart Rhythm Center at New York University’s Langone Medical Center, said, “The answer isn’t just to keep implanting everybody” who fits the current guidelines.
More doctors are now thinking twice. From a peak of 160,000 new patients in 2005, the number has fallen to less than 140,000 last year, according to Lawrence H. Biegelsen, an analyst at Wachovia Capital Markets. He predicts this year’s total will end up even lower.
For the manufacturers, the numbers translate to a decline in defibrillator sales to $3.94 billion in this country last year, down from $4.29 billion in 2005, Mr. Biegelsen said.
Only overseas, where defibrillators have been slower to catch on, has the number of new implants continued to rise, hitting a new sales high of $1.93 billion last year.
Many patients, of course, are grateful for their defibrillators. “It’s saved me at least four times, including two when I passed out completely,” Matthew M. Murray, a 55-year-old former engineer in Riverbank, Calif., said of his implant.
And some experts worry that the pendulum may have swung too far away from defibrillators — putting countless lives at risk among people with the heart abnormalities and ailments most likely to cause cardiac arrest. At least several hundred thousand people in this country have such conditions, and some estimates place the figure at more than a million.
Medtronic, the leading maker of defibrillators, contends that each day 500 deaths are caused by sudden cardiac arrests among people who meet the current medical guidelines for the devices but do not have them.
(The NBC journalist Tim Russert, who died earlier this year, reportedly suffered a heart attack after an artery was blocked. While Mr. Russert had a history of heart disease, his condition was not one for which a defibrillator would have been prescribed.)
Dr. Eric N. Prystowsky, a nationally renowned heart rhythm specialist in Indianapolis, said every doctor in his field was haunted by individual cases, like that of a Purdue University graduate student who was referred to Dr. Prystowsky for a defibrillator. The student had an abnormally thick heart muscle, a known risk for sudden cardiac arrest.
“He kept putting it off,” Dr. Prystowsky said of the decision to get a defibrillator. “Six weeks later, his fiancée called to say he had been found dead in bed.”
Cases like that may be inevitable as long as doctors cannot give patients more certainty about whether a defibrillator will actually help them.
Better clues could be submerged in the medical records of the people who have gotten defibrillators over the decades. Three years ago, Medicare ordered the creation of a nationwide registry, or database, for implanted defibrillators. Overseen by two leading professional groups, the American College of Cardiology and the Heart Rhythm Society, the registry has amassed about 270,000 records from 1,500 hospitals.
But the data mining has only recently begun, and results are not expected before 2010 at the earliest.
There is no guarantee that the information will lead to more effective use of defibrillators. Unlike drugs, many medical devices evolve so quickly that long-term data on their performance can be obsolete by the time it is available.
There are also efforts to find genetic markers and to develop new diagnostic tests that might more precisely identify patients who are predisposed to the type of sudden cardiac arrest a defibrillator could prevent. So far, though, the only federally approved screening test identifies some patients who are unlikely to need a defibrillator in the next year — not those most likely to require one.
The defibrillator decline began after highly publicized reports of a small number of deadly malfunctions. The biggest blow came in June 2005, when the Guidant Corporation — later acquired by Boston Scientific — recalled 29,000 implanted defibrillators because of flaws that might have caused them to short-circuit instead of delivering critical shocks. At the time, at least two deaths had been linked to the failure.
Medtronic, the market leader, and St. Jude Medical, the third major player, subsequently announced product recalls, although neither was prompted by known deaths.
Heading into 2007, as those headlines faded, many analysts predicted a rebound in defibrillator sales. But last fall Medtronic recalled its newest version of the main wire that connects a defibrillator to the heart. A small percentage of the more than 200,000 Fidelis-brand leads that had been implanted were developing fractures suspected of either preventing some defibrillators from delivering shocks when needed or causing them to deliver unnecessary shocks.
Even with properly functioning devices, patients risk unnecessary shocks — jolts recipients often describe as a painful and frightening kick in the chest. “Almost as many get shocked unnecessarily as benefit,” Dr. Paul J. Hauptman, a professor of medicine at St. Louis University, said.
And even problem-free patients need surgery to replace their unit’s batteries when they run low. Most of today’s batteries are expected to last five to seven years. Manufacturers say patients generally get better software and longer battery life with each replacement. But the repeat procedures also raise costs and risks.
Meanwhile, there are signs that improved treatment of cardiac disease with drugs, diet and behavioral changes could be reducing the need for defibrillators. At a meeting of heart rhythm specialists in May in San Francisco, Dr. Douglas P. Zipes, an Indiana University medical professor, cited data suggesting a decline in the percentage of heart patients who suffered the kinds of heart stoppages that defibrillators were intended to address.
Hoping to stay relevant, the makers of defibrillators have been developing higher-priced devices with new features, including software to limit unnecessary shocks. Most are built to communicate wirelessly, allowing doctors to remotely monitor their performance. Many can perform other rhythm-regulating functions, like synchronizing contractions in different chambers of the heart.
“Adding additional therapy will get at more of the market,” said Daniel J. Starks, chief executive of St. Jude Medical, citing plans to add sensors that could warn of impending heart failure. But adding complexity could also make it even more difficult to calculate the costs and benefits of implanting the devices in the first place.
That bothers patients like one 50-year-old business consultant in the San Francisco Bay Area. The man, who declined to be identified for fear of alarming his clients, ignored recommendations from three doctors to get a defibrillator. Online research suggested his risk of sudden cardiac arrest would be 3 percent a year without a defibrillator — and about 1 percent with one.
Doctors thinking about thousands of patients might see that as a significant difference, he said. But for him, he said, it did not seem a fair tradeoff for becoming “part of the medical-industrial complex for the rest of your life.”
Defibrillators Are Lifesaver, but Risks Give Pause
By BARNABY J. FEDER
The implanted defibrillator, a device that can automatically shock an erratically beating heart back to a normal rhythm, has been proved to save lives. Hence its nickname: an emergency room in the chest. Major medical groups have recommended that more patients receive the devices.
But in the last two years the number of patients receiving defibrillators has actually declined, as more doctors and patients decide the risks and uncertainties the devices pose may outweigh their potential benefits.
This trend — the first decline since implanted defibrillators were introduced in 1985 — has spotlighted a shortcoming that health experts have struggled with for years. Simply put, there is no adequate tool or test to predict which of the heart patients who might seem good candidates to get the expensive devices are the ones most likely to ever need their life-saving shock.
Defibrillators have undoubtedly saved the lives of tens of thousands of Americans. That is why insurers still typically pay for the devices and the surgical procedure to implant them, which can top $50,000 for each patient.
What makes many doctors and patients increasingly wary, though, is a string of highly publicized recalls in recent years, along with mounting evidence suggesting that a vast majority of people who get a defibrillator never need it.
Industry estimates and medical studies indicate that defibrillators have saved the lives of 10 percent of the more than 600,000 people in this country who have received them, at most. While survivors would no doubt take those odds, 9 of 10 people who get defibrillators receive no medical benefit. One big long-term medical study indicated the odds of a defibrillator saving a patient’s life might be even slimmer — about 1 in 14, over the five-year period studied.
The problem that defibrillators pose is in some ways singular among medical technologies. For devices like artificial knees, which improve lives but do not save them, few people would settle for only a 1 in 10 chance of success. For a potentially life-saving cancer drug, a patient might grasp at even much slimmer odds. Where defibrillators differ is that they are only a powerful standby — ready to intervene if necessary, but unlikely ever to be called into service.
If defibrillators were simply $50,000 life insurance policies, the relatively low rate of payoff might not matter much. But the long-shot statistics are significant to people who must weigh the risks of infection and malfunction after they have an electronic device anchored inside their hearts and its wires threaded through their arteries.
The slim odds also have large implications for the United States health care bill, adding billions of dollars annually to Medicare spending and to insurance payments. Dr. Larry A. Chinitz, director of the Heart Rhythm Center at New York University’s Langone Medical Center, said, “The answer isn’t just to keep implanting everybody” who fits the current guidelines.
More doctors are now thinking twice. From a peak of 160,000 new patients in 2005, the number has fallen to less than 140,000 last year, according to Lawrence H. Biegelsen, an analyst at Wachovia Capital Markets. He predicts this year’s total will end up even lower.
For the manufacturers, the numbers translate to a decline in defibrillator sales to $3.94 billion in this country last year, down from $4.29 billion in 2005, Mr. Biegelsen said.
Only overseas, where defibrillators have been slower to catch on, has the number of new implants continued to rise, hitting a new sales high of $1.93 billion last year.
Many patients, of course, are grateful for their defibrillators. “It’s saved me at least four times, including two when I passed out completely,” Matthew M. Murray, a 55-year-old former engineer in Riverbank, Calif., said of his implant.
And some experts worry that the pendulum may have swung too far away from defibrillators — putting countless lives at risk among people with the heart abnormalities and ailments most likely to cause cardiac arrest. At least several hundred thousand people in this country have such conditions, and some estimates place the figure at more than a million.
Medtronic, the leading maker of defibrillators, contends that each day 500 deaths are caused by sudden cardiac arrests among people who meet the current medical guidelines for the devices but do not have them.
(The NBC journalist Tim Russert, who died earlier this year, reportedly suffered a heart attack after an artery was blocked. While Mr. Russert had a history of heart disease, his condition was not one for which a defibrillator would have been prescribed.)
Dr. Eric N. Prystowsky, a nationally renowned heart rhythm specialist in Indianapolis, said every doctor in his field was haunted by individual cases, like that of a Purdue University graduate student who was referred to Dr. Prystowsky for a defibrillator. The student had an abnormally thick heart muscle, a known risk for sudden cardiac arrest.
“He kept putting it off,” Dr. Prystowsky said of the decision to get a defibrillator. “Six weeks later, his fiancée called to say he had been found dead in bed.”
Cases like that may be inevitable as long as doctors cannot give patients more certainty about whether a defibrillator will actually help them.
Better clues could be submerged in the medical records of the people who have gotten defibrillators over the decades. Three years ago, Medicare ordered the creation of a nationwide registry, or database, for implanted defibrillators. Overseen by two leading professional groups, the American College of Cardiology and the Heart Rhythm Society, the registry has amassed about 270,000 records from 1,500 hospitals.
But the data mining has only recently begun, and results are not expected before 2010 at the earliest.
There is no guarantee that the information will lead to more effective use of defibrillators. Unlike drugs, many medical devices evolve so quickly that long-term data on their performance can be obsolete by the time it is available.
There are also efforts to find genetic markers and to develop new diagnostic tests that might more precisely identify patients who are predisposed to the type of sudden cardiac arrest a defibrillator could prevent. So far, though, the only federally approved screening test identifies some patients who are unlikely to need a defibrillator in the next year — not those most likely to require one.
The defibrillator decline began after highly publicized reports of a small number of deadly malfunctions. The biggest blow came in June 2005, when the Guidant Corporation — later acquired by Boston Scientific — recalled 29,000 implanted defibrillators because of flaws that might have caused them to short-circuit instead of delivering critical shocks. At the time, at least two deaths had been linked to the failure.
Medtronic, the market leader, and St. Jude Medical, the third major player, subsequently announced product recalls, although neither was prompted by known deaths.
Heading into 2007, as those headlines faded, many analysts predicted a rebound in defibrillator sales. But last fall Medtronic recalled its newest version of the main wire that connects a defibrillator to the heart. A small percentage of the more than 200,000 Fidelis-brand leads that had been implanted were developing fractures suspected of either preventing some defibrillators from delivering shocks when needed or causing them to deliver unnecessary shocks.
Even with properly functioning devices, patients risk unnecessary shocks — jolts recipients often describe as a painful and frightening kick in the chest. “Almost as many get shocked unnecessarily as benefit,” Dr. Paul J. Hauptman, a professor of medicine at St. Louis University, said.
And even problem-free patients need surgery to replace their unit’s batteries when they run low. Most of today’s batteries are expected to last five to seven years. Manufacturers say patients generally get better software and longer battery life with each replacement. But the repeat procedures also raise costs and risks.
Meanwhile, there are signs that improved treatment of cardiac disease with drugs, diet and behavioral changes could be reducing the need for defibrillators. At a meeting of heart rhythm specialists in May in San Francisco, Dr. Douglas P. Zipes, an Indiana University medical professor, cited data suggesting a decline in the percentage of heart patients who suffered the kinds of heart stoppages that defibrillators were intended to address.
Hoping to stay relevant, the makers of defibrillators have been developing higher-priced devices with new features, including software to limit unnecessary shocks. Most are built to communicate wirelessly, allowing doctors to remotely monitor their performance. Many can perform other rhythm-regulating functions, like synchronizing contractions in different chambers of the heart.
“Adding additional therapy will get at more of the market,” said Daniel J. Starks, chief executive of St. Jude Medical, citing plans to add sensors that could warn of impending heart failure. But adding complexity could also make it even more difficult to calculate the costs and benefits of implanting the devices in the first place.
That bothers patients like one 50-year-old business consultant in the San Francisco Bay Area. The man, who declined to be identified for fear of alarming his clients, ignored recommendations from three doctors to get a defibrillator. Online research suggested his risk of sudden cardiac arrest would be 3 percent a year without a defibrillator — and about 1 percent with one.
Doctors thinking about thousands of patients might see that as a significant difference, he said. But for him, he said, it did not seem a fair tradeoff for becoming “part of the medical-industrial complex for the rest of your life.”
Tuesday, August 05, 2008
Lilly Diabetes Drug Shows a Life-Extending Promise
August 5, 2008
Lilly Diabetes Drug Shows a Life-Extending Promise
By ALEX BERENSON
Can Byetta, an injectable drug that lowers blood sugar, really help people with diabetes to live longer?
Possibly, according to the results of a major clinical trial presented at the American Diabetes Association annual conference. In the trial, called Accord, patients with Type 2 diabetes were prescribed Byetta or any of several other diabetes medicines. Patients who took Byetta had a much lower chance of dying, about 75 percent lower, than those who took any other drug.
The finding, presented in June, has generated a stir among diabetes researchers, although so far it has attracted little public notice. Neither Eli Lilly or Amylin, the companies that jointly market Byetta, is publicizing the findings, in part because no one is sure whether the reduction in the death rate is real or a chance finding. Only about 825 patients in the 10,000-patient Accord trial took Byetta, and those who did were likelier to be healthier than other patients.
“We don’t know whether it’s the drug or the healthy participant,” said Dr. Michael Miller, professor of biostatistics at Wake Forest University and the lead statistician on the Accord trial.
The trial’s finding came as a surprise even to Lilly and Amylin, said Dr. James Malone, the global medical director of Byetta for Lilly.
“We were not aware of the results before they were presented at A.D.A., and I was sitting in the audience and my jaw just dropped,” Dr. Malone said. The trials that Lilly and Amylin have conducted on Byetta, have not shown a reduction in mortality in patients taking the medicine, but they were not intended to do so.
Although Byetta has been a moderate success in the market, with sales expected to reach about $700 million this year, prescriptions are short of what analysts had forecast when the medicine was introduced in 2005.
For the Accord finding to be proved, it must be tested in a large trial that would compare the cardiac health and overall death rates of thousands of patients, half receiving Byetta and half receiving a placebo. So far, Lilly and Amylin have not committed to undertaking such a trial, which would take years and cost tens of millions of dollars.
Further complicating the issue is that the two companies are working a reformulated version of Byetta, which could be injected once weekly instead of twice daily, and they may prefer to run the trial on the new medicine, which has not yet been approved by the Food and Drug Administration.
Dr. Malone said the two companies hoped to make a decision on holding a large mortality trial by the end of the year.
Even so, the finding adds to an emerging body of evidence that Byetta — the first in a new class of diabetes medicines called incretin mimetics — may work better than other diabetes medicines, at least for people who can tolerate its side effects, which can include severe nausea.
Byetta is less likely than other diabetes medicines to cause hypoglycemia, or dangerously low blood sugar. In addition, while most diabetes medicines cause patients to gain weight, patients on Byetta typically lose several pounds each year on the medicine. Weight gain is associated with cardiovascular problems, the most common causes of death for people with diabetes.
“My suspicion is that when you look at the determinants of mortality, which were weight gain and hypoglycemia in that study, Byetta would be the antimortality drug, because it’s associated with weight loss and less hypoglycemia,” said Dr. Alan Garber, an endocrinologist and professor of medicine at Baylor.
In addition, animal trials offer some evidence that Byetta may directly benefit the heart, Dr. Malone said.
Byetta, generically called exenatide, is a synthetic version of a protein originally discovered in the venom of a lizard, the Gila monster. It encourages digestion and the production of insulin. Byetta is currently approved for use alongside other diabetes drugs, and Lilly and Amylin have asked the F.D.A. to approve it as a monotherapy as well.
When Byetta was introduced in 2005, prescriptions for it grew rapidly. But for the last year, Byetta prescriptions have been roughly flat at about 250,000 a month.
Doctors say that some patients cannot tolerate the nausea that Byetta can cause and others do not like injecting the medicine twice daily. Concerns about pancreatitis, an inflammation of the pancreas that can be fatal in rare cases, have also hurt the drug, although Byetta has not been proved to cause pancreatitis.
Dr. Joel Zonszein, an endocrinologist at Montefiore Medical Center in the Bronx, said some primary care doctors do not like to prescribe Byetta because they must teach patients how to give injections, a time-consuming process. “It is a drug that is difficult to prescribe,” Dr. Zonszein said.
Meanwhile, prescriptions for Januvia, a medicine in pill form from Merck that works in a somewhat similar way as Byetta, have taken off since Merck introduced it in October 2006. More than 500,000 patients a month are being given prescriptions for Januvia or Janumet, which combines Januvia with a second diabetes medicine in a single pill.
“Januvia has been effectively marketed in the primary care community,” said Dr. John Buse, vice chairman for the Accord study and professor of medicine at the University of North Carolina, Chapel Hill. “I think there is some misunderstanding about the relationship between Januvia and Byetta among primary care providers.”
Dr. Buse said that the data from Accord was intriguing but not enough to persuade him that Byetta could reduce deaths in diabetes patients.
“The number of patients in Accord that were treated with exenatide was a very small proportion of the total patients in Accord, and they got exenatide relatively late in the trial,” he said. He said he hoped Lilly and Amylin would decide to invest in the trial necessary to test Byetta’s effect on mortality.
“They need to do it,” he said.
Subscribe to:
Posts (Atom)