Panel urges the creation of a compensation system for research victims - The Washington Post

The United States should create a system to compensate people who are harmed by participating in scientific research, a panel of federal advisers recommended Tuesday.

Many other countries require sponsors of studies and researchers to carry insurance for research-related injuries or have other ways to compensate volunteers who are harmed, making the United States an "outlier," the subcommittee of the Presidential Commission for the Study of Bioethical Issues concluded.

"The panel felt strongly that it was wrong and a mistake that the United States was an outlier in not specifying any system for compensation for research subjects other than, 'You get a lawyer and sue,'" said Amy Gutmann of the University of Pennsylvania, who chairs the commission and served on the subcommittee.

The recommendation came on the second day of a two-day public hearing to air the results of a commission probe into medical experiments that the U.S. government researchers conducted in Guatemala in the 1940s.

The recently uncovered studies involved more than 5,500 men, women and children who were unwittingly drafted into tests involving the venereal diseases syphilis, gonorrhea and chancroid. The tests included deliberately — sometimes grotesquely — attempting to infect subjects without their permission or knowledge.

On Monday, the commission revealed that the researchers had obtained consent first before conducting earlier, similar experiments on inmates in Terre Haute, Ind., and hid what they were doing in Guatemala. This, the commission found, clearly showed that the doctors knew their conduct was unethical.

In the government-sponsored studies conducted in Guatemala between 1946 and 1948, doctors tried to infect prisoners, soldiers and mental patients by giving them prostitutes who were carrying the diseases or were infected by the researchers. The researchers also scraped sensitive parts of subjects' anatomy to expose wounds to disease-causing bacteria, poured infectious pus into subjects' eyes, and injected some victims' spines.

On Tuesday, the 13-member commission discussed the 48-page report outlining the findings of a 14-member international subcommittee investigating whether current rules adequately protect people in medical studies from physical harm or unethical treatment internationally.

The experts in bioethics and biomedical research from India, Uganda, China, Russia, Brazil, Argentina, Belgium Guatemala, Egypt and the United States met in London, Washington and Philadelphia and made five broad recommendations.

"The United States should implement a system to compensate research subjects for research related injuries," said Christine Grady of the National Institutes of Health, who helped present the findings of the subcommittee. "Many countries around the world and some U.S. research institutions have actually moved forward and developed compensation systems."

One "promising model" for a compensation system could be the U.S. National Vaccine Injury Compensation Program, a no-fault alternative to traditional lawsuits that compensates people injured by vaccines, the panel said.

India and Brazil have bioethics committees that "ensure that research sponsors pay compensation to participants injured in research," the panel wrote. The University of Washington uses a "self-insured no-fault" system.

President Obama ordered the probe when the experiments were made public in October along with an unusual public apology by his secretaries of state and health and human services.

After filing a report in September, the commission will meet again in November to come up with ways to bolster protections for research subjects internationally and in the United States. It will issue a final report in December. The Guatemalan government is conducting its own investigation, but has twice postponed briefing the commission.

Wellesley College historian Susan M. Reverby uncovered the disturbing experiments while reading papers from John C. Cutler, a doctor with the federal government's Public Health Service. Cutler participated in the Tuskegee experiment, in which hundreds of African American men with syphilis in Alabama were left untreated to study the disease between 1932 and 1972. Cutler died in 2003.

In the Guatemala case, about 700 of the subjects were treated, but it remains unclear whether their care was adequate. About 83 of the subjects died, but investigators have been unable to determine whether any deaths were caused by the studies.

The Annals of Extreme Surgery -

The heat is on again in the world of cancer treatment, both literally and figuratively.

More and more doctors are now using an extremely aggressive procedure to treat certain colorectal and ovarian cancers called Hipec, in which patients first undergo surgery to remove any visible cancer, then have heated chemotherapy pumped into the abdominal cavity for 90 minutes to kill any remaining cells.

Although it has given some patients hope, there is almost no evidence that the treatment is more effective than traditional chemotherapy — besides one small trial in the Netherlands over a decade ago that did show a benefit, but in which 8 percent of the participants died from the procedure itself.

We shouldn't be surprised by the sudden emergence of this therapy. Heated chemotherapy is the latest in a long list of very toxic treatments used by well-meaning cancer doctors who have confused doing more for patients with doing what is best for them.

History tells us that this "more is better" dictum is rarely true.

Aggressive cancer therapy started in the late 19th century with the radical mastectomy, which involved the removal of the breast, along with the chest muscle below it and nearby lymph nodes, and was championed by William S. Halsted, a surgeon at Johns Hopkins.

In the following decades, Dr. Halsted's methods became more and more popular, particularly after World War II, when surgeons who had performed heroic operations on European battlefields returned to America optimistic about what could be achieved in cancer surgery. In an attempt to eradicate all potentially dangerous cells without the assistance of chemotherapy — which was not yet in wide use — surgeons began removing even parts of the sternum and rib cage of certain breast cancer patients in something called a super-radical mastectomy.

If the cancer had spread into the arms, surgeons at times removed entire shoulders (forequarter amputations). If the cancer was in the legs, part of the pelvis was removed with the leg (hindquarter amputations). The most aggressive operation of all was probably the pelvic exenteration, devised by the New York gynecologist Alexander Brunschwig. For cancers that had spread throughout a woman's pelvis, he removed not only her gynecological organs but also her bladder and rectum.

The goal of these operations was straightforward: to remove as many cancer cells as possible, which would theoretically prolong the survival of patients and possibly even cure them. The problem was that none of these procedures had been formally tested in controlled clinical trials. By the 1960s, it had become clear that they were of little or no benefit, while causing dying cancer patients disfigurement and suffering.

Why such enthusiasm for aggressive surgery? The explanation can be gleaned from the language surgeons used to justify their operations. Military metaphors were ubiquitous. In 1946, Cushman Haagensen warned his colleagues against "surgical cowardice" in the face of the "formidable enemy" that was cancer. Jerome A. Urban, the father of the super-radical mastectomy, was fond of saying "lesser surgery is done by lesser surgeons."

It was not only surgeons who made these assumptions. In the late 1980s, oncologists began treating metastatic breast cancer patients with a highly toxic and expensive regimen of so-called very-high-dose chemotherapy, followed by bone marrow transplants. Once again, early data proved misleading. Women who received this treatment turned out to live no longer than those getting standard chemotherapy, and many died from either the high doses or the side effects of the transplants.

Cancer patients and their families, desperate for anything that might work after exhausting all other treatment options, are also part of the problem. But the history of cancer treatment provides a crucial cautionary tale for both those seeking out and those providing heated chemotherapy today. Doing more for cancer patients has often served a cultural as opposed to a scientific purpose, reflecting more the desire to defeat the cancer enemy than to take care of sick patients. Hospitals should offer heated chemotherapy — and insurance companies should pay for it — only after controlled trials have proved its effectiveness.

In the meantime, we should remember not to conflate our efforts with our achievements.

Barron H. Lerner, a professor of medicine and public health at Columbia, is the author of "The Breast Cancer Wars: Hope, Fear and the Pursuit of a Cure in Twentieth-Century America" and the forthcoming "One for the Road: Drunk Driving Since 1900."

An Insurance Maze for U.S. Doctors -

A former colleague from Canada who practiced medicine with me here in the States never hesitated to make one thing clear to me: He couldn't wait to get back.

It wasn't the cultural life that he missed, nor was it the ex-girlfriend I always suspected he pined for. It was the medicine.

"It's different," he would say wistfully, without elaborating. "Practicing medicine is just different over there."

A study published this month in the journal Health Affairs made me think of my colleague again and offered one likely possibility for his return to Canada: There, he had more time to focus on his patients.

Researchers asked hundreds of physicians and administrators in private practices across the United States and Canada how much time they spent each day with insurers and other third-party payers, tracking down information for claims that were denied or incorrectly paid, resolving questions about insurance coverage for prescription drugs or diagnostic tests, and filing the different forms required by each and every insurance company.

Physicians in Canada, where health care is administered mainly by the government, did spend a good deal of time and money communicating with their payers. But American doctors in the study spent far more dealing with multiple health plans: more than $80,000 per year per physician, or roughly four times as much as their northern counterparts. And their offices spent as many as 21 hours per week with payers, nearly 10 times as much as the Canadian offices.

"The amount of time we spend on this is just crazy," said Dr. Sara L. Star, a partner in a three-physician pediatrics practice in suburban Chicago. "But each insurance company has its own language, its own set of rules and specific contracts with certain laboratories, hospitals, physicians and pharmaceutical companies."

And when those companies offer multiple "insurance products," the convoluted coverage grid acquires yet another level of complexity. Each "product" comes with its own unique permutation and combination of authorization requirements, rules for claims and list of approved prescription drugs.

Large practices often choose to outsource the job to firms that specialize in wading through the labyrinthine rules and regulations. Some hire several nurses or administrators to work exclusively with insurers, with each specializing in the arcane rules of a single insurer. But most primary care providers in this country — clinicians who are part of practices with five or fewer physicians — cannot afford to pay for additional help. Instead, they must make their way through the thicket of insurers and rules by themselves.

The complicated task inevitably gets in the way of patient care.

A young patient complaining of extreme fatigue, for example, might benefit from a $40 blood test that could confirm infectious mononucleosis in 10 minutes. But a doctor cannot order the simple test without first checking with the insurance company to see if it is covered and if there are any constraints on where the patient's blood can be drawn and the test run.

Tracking down answers often means phone calls with long periods on hold, digging up old patient information and even recruiting office workers to act as specimen couriers to other labs and hospitals in order to expedite results or save frail patients or harried family members the hassle of traveling to an "approved site" for a test or procedure. "If someone comes in with a sick infant who needs a test, we often eat the costs and draw the blood ourselves," Dr. Star said. "We aren't going to tell them to put that kid in a car seat, drive a mile to an approved lab, park, register, then wait in line."

Even more confusing are frequent changes in health care plans, particularly regarding prescription drugs. Every week, payers send physicians' offices notifications of changes in their list of approved medications, lists that run to hundreds of different drugs. The sheer volume of new information makes it impossible for doctors to keep up. "Physicians get into medical school because we can follow rules," said Dr. Marian Bouchard, a family doctor who practices with two other physicians and a nurse practitioner in Bristol, Vt. "But none of us can or want to follow the minutiae of a hundred rules at once, especially when we are trying to be present for our patients."

The authors of the study offer several recommendations to reduce the confusion and inefficiency of interactions between physician practices and payers. Not surprisingly, they propose simplifying the forms and procedures that add to costs without improving quality. "There are rules that really save money or improve patient care that health plans won't want to change," said Sean Nicholson, one of the study authors and an economist in the department of policy analysis and management at Cornell University. "But there are also a lot of things that don't matter that they could and should standardize."

The insurance industry, for example, could embrace a single set of universal standards to measure quality rather than the dozens that are currently used. They could adopt a uniform process of obtaining authorization for tests, procedures or consultations. And while widespread adoption of electronic medical records and changes in how doctors are reimbursed may eventually decrease some administrative burdens, the results of the study leave little doubt as to the costs now and in the foreseeable future for doctors and patients.

"We aren't saying that we should go to a single-payer system," Dr. Nicholson added. "But it's important to know exactly what all the benefits of the current costs are."

Deciding to Die, Then Shown the Door -

Armond and Dorothy Rudolph had talked about their plans for more than a decade. They had a mutual horror of a lingering decline in their final years. They'd joined an organization that supports the right to end life when illness or pain becomes overwhelming; they'd attended meetings and given both their children literature on the subject. They'd drafted advance directives.
"Their great fear was that they'd end up in a nursing home," their son, Neil Rudolph, told me. "That was hell for them, to have people waiting on them, to have no independence."
As it happened, the elder Rudolphs had a long and satisfying old age in Albuquerque, N.M., where they lived for 60 years; they gardened and volunteered with the Boy Scouts and served as leaders in their Presbyterian church. 

When their large house and gardens became difficult to maintain, they built a smaller one in a neighboring town, then moved again to a retirement community.
Mrs. Rudolph had nursed her own mother through four years of bone cancer, he said. "She saw her mother die a slow, wasting death. She felt pinned down for years, and she felt guilty about feeling pinned down. She didn't want that to be our experience."

"At that point, some health issues began to emerge," their son said. Mrs. Rudolph broke her hip and was in and out of rehab, suffering frightening episodes of delirium.
"Dad had a permanent catheter," said Neil Rudolph. "Physically and mentally, they began to go downhill." In October, they entered an assisted living facility called The Village at Alameda, thinking it would be their last home.
The Rudolphs faced increasing pain and debility. Mr. Rudolph, 92, suffered from spinal stenosis; Mrs. Rudolph, 90, had become largely immobile. Both showed symptoms of early dementia. So in January, they set in motion their plan to stop eating and drinking.
Current management would not comment beyond an e-mailed statement saying that when a resident "requires alternate placement, medical attention, or a level of care beyond the facility's capabilities, we have an obligation to notify a medical provider." Fundamental Long Term Care, the firm that owns the facility and more than 100 others in 14 states, did not respond to requests for interviews.
And the facility tried to evict the couple. The administrators, apparently on orders from the corporate legal department in Maryland, told the family the Rudolphs had to leave the next day.
As Neil Rudolph recalls the events, he protested that the couple — already on Day 4 of their fast — had nowhere to go. He also pointed out that their contract required 30 days' notice of discharge. The following day, administrators called 911, reported a suicide attempt and told the paramedics to take the elder Rudolphs to a hospital.
So much for the peaceful passage.
Voluntarily stopping eating and drinking — as the Rudolphs had learned from consulting with Compassion & Choices, the largest national organization working to expand end-of-life options — is a legal way to hasten death without drugs or violence, usually in about two weeks. In a survey of hospice nurses in Oregon, published in The New England Journal of Medicine in 2003, respondents reported that most of their terminally ill patients who had deliberately refused food and fluids had "a good death," with low levels of pain or suffering.
"They said, 'That's what we want to do,'" Neil Rudolph said, emphasizing that his parents' decision was hardly impulsive or caused by a bout with depression. He and his sister, Elaine Spence, and their spouses had come from Colorado to be with their parents and had called in a hospice organization. "We all discussed what it meant and whether they were sure," he said.
When his parents said they were, he helped them write a statement affirming their decision and then told the assisted living administrators about their plan.
Shortly thereafter, two emergency squads, from the Albuquerque Fire Department and Albuquerque Ambulance Services, converged on the scene. Neil Rudolph's wife called a reporter from The Albuquerque Journal, to whom the elder Rudolphs gave outraged and lucid interviews. The emergency crews soon called a doctor at the University of New Mexico's emergency medicine department, part of a consortium that consults when a 911 call brings a situation outside the norm — and this certainly qualified.
"They were stuck between divergent opinions and said, 'We need some guidance,'" recalled Dr. Drew Harrell, who was on call. He drove over to assist.
The standoff illustrates the legal tangle surrounding V.S.E.D., short for voluntarily stopping eating and drinking.
Under federal law, V.S.E.D. is indeed legal in every state, said Charles Sabatino, who directs the American Bar Association Commission on Law and Aging. "That a competent person can refuse any medical intervention, including tube feeding, has been recognized by the Supreme Court," he said.
It also is established in the federal Patient Self-Determination Act. Even a dementia diagnosis doesn't necessarily mean that someone lacks legal capacity to make that decision.
But, he added, "While the theory may be clean, the execution may get messy." Those who oppose the act for religious or ethical reasons (or fear of lawsuits) can throw up roadblocks.
New Mexico's Uniform Health-Care Decisions Act spells out an individual's right to stop eating and drinking, said Barbara Mathis, who helped draft the legislation and has taught at the University of New Mexico Health Sciences Center Institute for Ethics. "I would have been happy to go to court for no pay and get a temporary restraining order to keep the family from getting kicked out" she said.
It never came to that. Dr. Harrell spoke with everyone involved, including separate and lengthy bedside discussions with Dorothy and Armond Rudolph. "They were able to very appropriately and eloquently explain their wishes and what they wanted to have done," he said. "They didn't feel the need to go to a hospital. They detailed that they wanted control over their own end-of-life issues."
Reassured that they understood the ramifications of their decision, "I made a determination that our services were not needed," he said. The Rudolphs signed papers showing they had declined transport.
Worried about further conflict, their children transferred the Rudolphs to a rented house in Albuquerque and moved in themselves. Even with daily or twice-daily hospice visits, the round-the-clock vigil was exhausting — "but satisfying," Neil Rudolph said. "This was what they wanted, and we could help them carry it out." After slipping into unconsciousness, Mrs. Rudolph died first, 10 days after starting the fast; her husband followed the next day.
"They did find the dignified and peaceful death they both sought, but it's also a cautionary tale," Neil Rudolph told reporters in Denver last week.
He has launched a campaign with Compassion & Choices to inform people about voluntarily stopping eating and drinking. The organization is circulating a rider to assisted living contracts that states, in part, "Facility will respect Resident's end-of-life choices and will not impede any course of treatment, or non-treatment, freely and rationally chosen by Resident."

Paula Span is the author of "When the Time Comes: Families With Aging Parents Share Their Struggles and Solutions."

Cut Medicare, Help Patients -

MEDICARE is going to be cut. That is inevitable. There is no way to solve the nation's long-term debt problem without reducing the growth rate of federal health care spending. The only question is whether the cuts will be smart ones.

Smart cuts eliminate spending on medical tests, treatments and procedures that don't work — or that cost significantly more than other treatments while delivering no better health outcomes. And they can be made without shortchanging patients. There are plenty of examples; here are three.

Late last year, the Food and Drug Administration determined that the drug Avastin, which has serious side effects, is not effective for treating breast cancer. Astonishingly, Medicare declared it will still pay for Avastin — at a cost of about $88,000 per year for each patient.

Consider colonoscopies. The United States Preventive Services Task Force recommends not doing colonoscopies for most people over 75 because there is no evidence that they save lives in this population. Moreover, the risk of perforating the intestines rises with age. Yet Medicare pays for the procedure regardless of the patient's age.

Every year more than 1 million cardiac stents are placed in patients to open blocked arteries. Stents are essential immediately after a heart attack, but a 2007 randomized trial conducted at 50 medical centers in the United States and Canada showed that for patients with stable heart disease, stents do not reduce the number of heart attacks or save lives when compared with drug therapy. And they are substantially more expensive.

Because stents are more effective at reducing pain in some patients, the best practice is to start patients on drug therapy and insert a stent only for those who do not respond to treatment. Yet many patients who receive stents paid for by Medicare are either experiencing no pain or have not tried medication first.

The list of procedures Medicare pays for that are proven to have no benefit goes on and on. Cutting payment for these is not rationing. It saves money, but it also protects patients from the pain, stress and risks associated with unnecessary care.

Smart cuts can also be achieved through better coordination of patient care. One program, at the University of Pennsylvania, sends a nurse to visit older adults at home immediately after they have been discharged from the hospital. By reducing readmissions, the program saves $5,000 per Medicare patient. It also improves health outcomes. By assigning a nurse case manager to high-cost Medicare patients, Massachusetts General Hospital has reduced spending on these patients by 4 to 5 percent and also reduced mortality.

Group Health Cooperative in Washington State transformed its primary care practices in a pilot program by creating teams of doctors, nurses and pharmacists who work together, extending its regular office visits to 30 minutes and introducing "care coordinators" who follow up with patients after office visits, hospitalizations and procedures. After two years, quality of care and patient satisfaction improved; emergency room visits declined by 29 percent and hospitalizations by 6 percent.

Unfortunately, Washington is preoccupied with ill-conceived cuts. Three kinds of cuts got serious consideration in the recent debt limit negotiations, and are likely to resurface as the special Congressional committee tries to achieve $1.5 trillion in additional deficit reduction:

• Meat-cleaver cuts hack spending indiscriminately. Across-the-board cuts in payments to Medicare providers (which will kick in if the special committee doesn't come to an agreement) fall into this category. Cuts that fail to distinguish between high-value and low-value medical care would do more harm than good.

• Cost-shifting cuts don't actually reduce health care spending; they just shift costs from the government to the private sector. Increasing Medicare's eligibility age from 65 to 67, as Senators Tom Coburn and Joseph Lieberman have proposed and as the Obama administration reportedly floated during the debt ceiling negotiations, is a classic example. While raising the eligibility age would reduce government spending on Medicare, it would shift the costs to individuals and businesses. It would also increase the number of uninsured 65- and 66-year-olds, leading to worse health outcomes and making it harder for older Americans to find work.

• Penny-wise, pound-foolish cuts reduce current spending by a little but raise future costs by a lot. Raising co-payments for office visits and medications is a good example. Research shows that when older adults are charged higher co-payments, they reduce their primary care visits and use of prescription drugs. But the research also shows that forgoing this outpatient care leads to an increase in expensive hospitalizations.

THE sad truth is, Washington is never going to do a good job of making smart cuts to Medicare. Elected officials hate being blamed for directly restricting access to medical treatments — even when those treatments are proven to be worthless. Moreover, much wasteful spending occurs in situations where care that is appropriate for some patients is given to patients for whom it is inappropriate. It is impossible for Medicare to write payment rules that cover all such circumstances.

The responsibility for ending unnecessary medical spending needs to be placed in the hands of doctors and hospitals. This can happen only if we change our fee-for-service payment system. Today doctors and hospitals that develop new programs to keep patients healthy lose money in two ways. They spend money re-designing care and then, with fewer office visits and hospitalizations, the payments they receive go down.

The seeds of a solution lie in the accountable care organizations, medical homes and bundled payment reforms that were authorized by last year's Affordable Care Act. Accountable care organizations are groups of health care providers and hospitals that work together to treat patients. Medical homes coordinate primary care services. And bundled payments consolidate the many costs of an episode of care, like a hospitalization, into a single payment, incentivizing efficient delivery of tests and treatments. All of these reforms allow payments to be based primarily on the number of patients cared for and the quality of that care rather than on the volume of services provided.

To control Medicare spending and reduce the deficit, we need to stop paying for wasteful procedures, accelerate adoption of the Affordable Care Act reforms and empower doctors, nurses and hospitals to provide higher-quality and more efficient care. The path to smart cuts is clear.

Ezekiel J. Emanuel, an oncologist and regular contributor to Op-Ed, will be a vice provost and professor of medical ethics and health policy at the University of Pennsylvania beginning in September. Jeffrey B. Liebman is a professor of public policy at Harvard. Both were White House advisers.

Complaints Soar on Hip Implants as Dangers Are Studied -

The federal government has received a surge in complaints in recent months about failed hip replacements, suggesting that serious problems persist with some types of artificial hips even as researchers scramble to evaluate the health dangers.

An analysis of federal data by The New York Times indicates that the Food and Drug Administration has received more than 5,000 reports since January about several widely used devices known as metal-on-metal hips, more than the agency had received about those devices in the previous four years combined.

The vast majority of filings appear to reflect patients who have had an all-metal hip removed, or will soon undergo such a procedure because a device failed after only a few years; typically, replacement hips last 15 years or more.

The mounting complaints confirm what many experts have feared — that all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007. About 7,700 complaints have been filed in connection with that recall.

Though immediate problems with the hip implants are not life-threatening, some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that the metal devices shed as they wear.

Hip replacement is one of the most common procedures in the United States and, until a recent sharp decline, all-metal implants — one in which both the artificial ball and cup are made of metal — accounted for nearly one-third of the estimated 250,000 replacements performed each year. According to one estimate, some 500,000 patients have received an all-metal replacement hip.

One of the most problematic devices, the A.S.R., or Articular Surface Replacement, was recalled last year by Johnson & Johnson and accounted for 75 percent of the complaints reviewed by The Times. A precise count of failed implants reported to the F.D.A. is hard to come by because of the agency's overlapping reporting system, though The Times sought to eliminate duplicate reports about the same incident. Some complaints came from outside the United States.

Under F.D.A. rules, many all-metal devices were sold without testing in patients or without a requirement that producers track their performance. But in an unusual intervention, the F.D.A. in May ordered producers to study how frequently the devices were failing and to examine the threat to patients. Now, researchers say, producers face substantial hurdles in recruiting the hundreds of patients needed to conduct sound studies because of the lack of patient registries.

"They are grasping at how they are going to get this information," said Dr. Robert S. Namba, an orthopedic surgeon with Kaiser Permanente.

In addition, researchers are struggling to understand the tissue damage caused by the metallic debris. While some patients experience pain, other patients with the same damage have no pain, complicating decisions about whether to remove devices.

As problems and questions grow, most surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available. Some researchers also fear that many all-metal hips suffer from a generic flaw. Current use of all metal devices has plummeted to about 5 percent of the market, though a few of the models are performing relatively well in select patients.

"It is like playing Russian roulette," said Dr. Geoffrey H. Westrich, an orthopedic surgeon at the Hospital for Special Surgery in New York, who has stopped using all-metal implants.

Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices, said he believed that producers would mount rigorous studies and find answers. But he acknowledged that it could take several years.

"There is not an existing infrastructure for studying this kind of information," Dr. Maisel said.

For many patients, it is too late. In 2008, Ann Morrison, a physical therapist from Newark, Del., received all-metal replacements for both of her hips. But Ms. Morrison, 50, soon experienced pain, rashes and inflammation.

Last year, the devices were replaced, but by then, she said, debris-caused tissue damage was so extensive that she now needs a brace to walk and still cannot work. She called the F.D.A.'s order for medical studies a "joke."

"We will be the little crash test dummies here until they figure out the health ramifications for us down the road," said Ms. Morrison, who has sued the DePuy division of Johnson & Johnson, which made her implants.

To conduct its analysis, The Times reviewed complaints filed with the F.D.A. from 2007 through this June for several implants, including the A.S.R. and the Durom cup, a component sold by Zimmer Holdings.

Typically, the number of complaints filed with the F.D.A. about a product understates a problem because while companies must file reports, doctors and patients do not have to. The filing volume for the A.S.R. and the Durom cup probably reflects a surge of lawsuits filed against their makers.

The Times review found some 7,500 complaints about the A.S.R., nearly 5,000 of them coming since January. In the case of the Durom cup, about 1,600 complaints were filed with the regulator from 2007 to this June.

Because complaints to the F.D.A. are not uniform, it is impossible to say how many adverse reports about all-metal hips have been submitted. For example, the Times analysis found some 200 complaints about an all-metal version of another DePuy device called the Pinnacle as well as 400 additional complaints that noted metal-related problems in Pinnacle patients. But the Pinnacle is sold in several versions, so it was not clear how many of the metal-related complaints were linked to the all-metal device.

A spokesman for Zimmer Holdings said the Times review was "in the ballpark" of the company's assessment of the drug administration's filings. A DePuy spokeswoman declined to disclose the number of A.S.R. complaints that the company forwarded to the F.D.A. She maintained that the Pinnacle was performing well.

DePuy, Zimmer and another producer of metal hips, Wright Medical, declined to discuss the study proposals they had submitted to the F.D.A. to comply with its May order. A fourth company, Biomet, said it had proposed mounting a study of 400 patients who received its devices that would draw in part on studies already under way. The F.D.A. declined to release producers' proposals, saying that they contained "confidential commercial information." The agency has until November to decide on the plans' adequacy.

In an effort to recruit patients, companies have recently contacted, researchers said, health systems like Kaiser Permanente and hospitals that operate their own implant registries.

Meanwhile, researchers say it may be a year before standard protocols are formulated that may be central to the future studies, like a uniform procedure to measure metallic ions in a patient's blood or how to calibrate diagnostic equipment to best detect tissue damage.

Health News, Medical Stories, Health Articles | Discover Magazine

One Word Can Save Your Life: No! - Newsweek

Dr. Stephen Smith, Professor emeritus of family medicine at Brown University School of Medicine, tells his physician not to order a PSA blood test for prostate cancer or an annual electrocardiogram to screen for heart irregularities, since neither test has been shown to save lives. Rather, both tests frequently find innocuous quirks that can lead to a dangerous odyssey of tests and procedures. Dr. Rita Redberg, professor of medicine at the University of California, San Francisco, and editor of the prestigious Archives of Internal Medicine, has no intention of having a screening mammogram even though her 50th birthday has come and gone. That's the age at which women are advised to get one. But, says Redberg, they detect too many false positives (suspicious spots that turn out, upon biopsy, to be nothing) and tumors that might regress on their own, and there is little if any evidence that they save lives.

These physicians are not anti-medicine. They are not trying to save money on their copayments or deductibles. And they are not trying to rein in the nation's soaring health-care costs, which at $2.7 trillion account for fully one sixth of every dollar spent in the U.S. They are applying to their personal lives a message they have become increasingly vocal about in their roles as biomedical researchers and doctors: more health care often means worse health. "There are many areas of medicine where not testing, not imaging, and not treating actually result in better health outcomes," Redberg says. In other words, "less is more." Archives, which is owned by the American Medical Association, has been publishing study after study about tests and treatments that do more harm than good.

That less health care can lead to better health and, conversely, that more health care can harm health, runs counter to most patients' conviction that screenings and treatments are inherently beneficial. That belief is fueled by the flood of new technologies and drugs that have reached the market in the past two or three decades, promising to prevent disease and extend life. Most of us wouldn't think twice if our doctor offered a test that has the power to expose a lurking tumor, or a clogged artery, or a heart arrhythmia. Better to know—and get treated—than to take any risks, the reasoning goes.

In fact, for many otherwise healthy people, tests often lead to more tests, which can lead to interventions based on a possible problem that may have gone away on its own or ultimately proved harmless. Patients can easily be fooled when a screening test detects, or an intervention treats, an abnormality, and their health improves, says cardiologist Michael Lauer of the National Heart, Lung, and Blood Institute. In fact, says Lauer, that abnormality may not have been the cause of the problem or a threat to future health: "All you've done is misclassify someone with no disease as having disease."

 PSA tests for prostate cancer (which more than 20 million U.S. men undergo every year) to surgery for chronic back pain to simple antiobiotics for sinus infection, a remarkable number and variety of tests and treatments are now proving either harmful or only as helpful as a placebo.

This realization comes at a time when Medicare has emerged as a fat target in the debate over taming the deficit, with politicians proposing to slash costs by raising the age of eligibility or even eliminating the program. Experts estimate that the U.S. spends hundreds of billions of dollars every year on medical procedures that provide no benefit or a substantial risk of harm, suggesting that Medicare could save both money and lives if it stopped paying for some common treatments. "There's a reason we spend almost twice as much per capita on health care [as other developed countries] with no gain in health or longevity," argues Dr. Steven Nissen, the noted cardiologist at the Cleveland Clinic. "We spend money like a drunken sailor on shore leave."

Many medical advances, of course, have saved lives and eased suffering for millions of people. Screening tests like mammograms can lead to early treatment of breast cancer, especially for women with hereditary risk or a strong family history of the disease. For cancer patients who report back pain, MRIs can prove invaluable for spotting tumors that have metastasized to the bones, allowing doctors to intervene before it's too late. The years between 1980 and 2004 saw a 50 percent decline in the death rate from coronary heart disease thanks to better treatments and drugs that reduce cholesterol and blood pressure. At least 7,300 lives are saved every year thanks to colonoscopies.

The dilemma, say a growing number of physicians and expert medical panels, is that some of this same health care that helps certain patients can, when offered to everyone else, be useless or even detrimental. Some of the most disturbing examples involve cardiology. At least five large, randomized controlled studies have analyzed treatments for stable heart patients who have nothing worse than mild chest pain. The studies compared invasive procedures including angioplasty, in which a surgeon mechanically widens a blocked blood vessel by crushing the fatty deposits called plaques; stenting, or propping open a vessel with wire mesh; and bypass surgery, grafting a new blood vessel onto a blocked one. Every study found that the surgical procedures didn't improve survival rates or quality of life more than noninvasive treatments including drugs (beta blockers, cholesterol-lowering statins, and aspirin), exercise, and a healthy diet. They were, however, far more expensive: stenting costs Medicare more than $1.6 billion a year.

If that finding makes you scratch your head—how can propping open a narrowed blood vessel not be wonderfully effective?—you're not alone. Many cardiologists had the same reaction when these studies were published. It turns out that the big blockages that show up on CT scans and other imaging, and that were long assumed to cause heart attacks, usually don't—but treating them can. That's because when you disrupt these blockages through surgery, you "spray a whole lot of debris down into the tiny blood vessels, which can trigger a heart attack or stroke," says Nortin Hadler, a professor of medicine at the University of North Carolina, whose book on overtreatment in the elderly, Rethinking Aging, will be published next month. Many of the 500,000 elective angioplasties (at least $50,000 each) performed every year are done on patients who could benefit more from drugs, exercise, and healthy eating.

New technology has sometimes made the problem more acute. Where once arterial blockages were detected by chest X-ray, now doctors can use cardiac CT angiography, which shows the heart and coronary arteries in dramatic 3-D. When it was introduced a decade ago to screen for cardiovascular disease, it seemed almost miraculous: a 2005 cover of Time trumpeted that it could "stop a heart attack before it happens." Difficult as it is to believe, however, there can be such a thing as too much information, especially from new imaging technology. "Our imaging and diagnostic tests are so good, we can see things we couldn't see before," says Lauer of the National Heart, Lung, and Blood Institute. "But our ability to understand what we're seeing and to know if we should intervene hasn't kept up."

In a recent study, John McEvoy, a heart specialist at Johns Hopkins Medical Institutions, and colleagues found that 1,000 low-risk patients who had CT angiography had no fewer heart attacks or deaths over the next 18 months than 1,000 patients who did not undergo the screening. But they did have more drugs, tests, and invasive procedures such as stenting, all of which carry a risk of side effects, surgical complications, and even death. The CT itself has a potential side effect: by exposing patients to high levels of radiation, it raises the risk of cancer. "Low-risk patients without symptoms don't benefit from CT angiography," says McEvoy, though high-risk patients with heart disease might.

The Cleveland Clinic's Nissen has seen firsthand what happens when doctors, armed with too much information, perform what turn out to be unnecessary procedures. In 2009 a 52-year-old woman with chest pain underwent a cardiac CT at a community hospital. Neither her LDL (bad) cholesterol nor her C-reactive protein (another risk factor for heart disease) were elevated. But since the CT showed several coronary plaques, her physicians performed coronary angiography. Complications ensued, and the woman wound up undergoing more procedures, one of which tore an artery. She eventually went to the Cleveland Clinic for a heart transplant—not because she had heart disease when it all started, says Nissen, but because of the cascading interventions triggered by the CT.

Nissen regularly counsels asymptomatic, low-risk patients against having cardiac CT, echocardiograms, and even treadmill stress tests; studies show they produce many false positives, leading to risky interventions. Even a clean scan can lead to worse health, if it makes people believe they can eat whatever they want and stop exercising. "I've had colleagues gain weight after a negative heart scan," apparently figuring they were home free, says UCSF's Redberg.

Radiologists and other physicians who diagnose or treat back pain have their own version of the CT: it's called magnetic resonance imaging, or MRI. Just as cardiac CT makes sense in principle, so does getting a high-resolution image of the spine if someone is suffering lower back pain with no clear cause. An MRI typically costs about $3,000 and is designed to spot everything from bulging discs to hairline fractures. Find any of those things, the logic goes, and you can treat the problem surgically. But there's a fundamental flaw: clinical trials have shown that back surgery, including vertebroplasty (putting special cement on a tiny spinal fracture) and spinal fusion, is no more effective at alleviating ordinary pain than plain-old rest and mild exercise. But like any surgery, it carries risks. Last year the American College of Physicians warned that "routine imaging [for low back pain] is not associated with clinically meaningful benefits but can lead to harms." That's because the "abnormalities" seen in an MRI often have nothing to do with the back pain (people without pain have them, too), but seeing something on a scan makes a physician feel compelled to get rid of it. "There is a longstanding fallacy among physicians that if you find something different from what you perceive to be 'normal,' then it must be the cause of the patient's problem," says UNC's Hadler.

Dr. James Goodwin, a geriatrician at the University of Texas Medical Branch, cites an extreme example of this fallacy in the case of a frail 84-year-old woman who was told by her gastroenterologist that it was time for another colonoscopy, just a few years after her last one showed no problems. She died when the procedure perforated her colon. Though this outcome is rare, the recommendation that led to the woman's death is all too common, says Goodwin, even though expert groups advise against screening colonscopies for anyone over 75 or who has had a normal result within the past 10 years. He says he was dumbfounded when his elderly patients kept receiving "reminders" from their gastroenterologists telling them it was time for another colonoscopy—seven or five or even two years after their last normal one.

Both curious and concerned, Goodwin launched a study of Medicare patients. Fully 46 percent had a screening colonoscopy fewer than seven years after a negative one. Making matters worse, many of them were over 80.

Medical practice also suffers from a kind of mission creep: if a treatment works in severe disease, some doctors assume it will work in milder disease. But that is not necessarily so. Antidepressants, for instance, have been shown in randomized trials to help with severe depression but not with moderate or mild depression, yet are widely prescribed for those conditions. Drugs called proton pump inhibitors (PPIs) are effective against gastric reflux and rare esophageal diseases as well as some ulcers, but at least half, and possibly 70 percent, of the 113 million U.S. prescriptions for PPIs each year are for conditions they don't help, such as run-of-the-mill stomachaches. PPIs can cause bone fractures, severe and hard-to-treat bacterial infections, and pneumonia. Millions of people are being put at risk unnecessarily, which is one reason treating adverse drug reactions costs the U.S. $200 billion a year.

Statins, common cholesterol-reducing drugs, may also not benefit some people who are taking them. Statins are proved to help people with both heart disease and high cholesterol, but not those with just high cholesterol. The drugs are nevertheless widely prescribed to patients who fit the latter description, despite adverse effects, such as severe muscle disease in up to 20 percent of patients. Similarly, cardiac resynchronization therapy, a special pacemaker that causes the right and left ventricles to beat in sync, can save the life of a patient with congestive heart failure whose ventricles are at least 150 milliseconds out of sync. Yet patients with a mistiming of 120-150 milliseconds are receiving the devices.

Low-tech tests should sometimes be avoided, too. In an Archives paper published this month, a panel of physicians, led by Brown's Smith, announced its first list of tests and treatments that should be dropped altogether for certain patients and ailments: antibiotics for sinus infections, imaging for low back pain, osteoporosis screening for women under 65, and electrocardiograms and other cardiac screening in low-risk patients. Even blood panels for healthy adults made the list. Today's comprehensive blood tests measure 15 or so enzymes, proteins, lipids, and the like. Yet by chance alone, if you test for 20 things, something will fall outside the bounds of "normal," often due to simple lab error.

Many doctors don't seem to be getting the message about useless and harmful health care. Medicare pays them more than $100 million a year for screening colonoscopies; some 40 percent are for people in whom they will almost certainly harm more than help. Arthroscopic knee surgery for osteoarthritis is performed about 650,000 times a year; studies show that it, too, is no more effective than placebo treatment, yet taxpayers and private insurers pay for it. And although several large studies, including the Occluded Artery Trial in 2006, have shown that inserting a stent to prop open a blocked artery more than 24 hours after a heart attack does not improve survival rates or reduce the risk of another coronary compared with drugs alone, the practice continues at a rate of 100,000 such procedures a year, estimate researchers led by Dr. Judith Hochman, a cardiologist at New York University. "We're killing more people than we're saving with these procedures," says UT's Goodwin. "It's as simple as that."

Bruce’s Cancer Diary « Bruce Feiler

Dear Friends and Family,

The morning sun is shimmering off Snug Harbor this week and the skies over Cape Cod are as bountiful as the blueberries our girls picked this morning. The clear days and fresh fields are a welcome relief from a long spell in New York marked by "May Gray," "June Gloom," and this year's Summer Solstice, the Cloudiest Day of the Year.

Last week I went to visit a friend I hadn't seen in a while. I sat in his chair in New York's trendy Meatpacking District surrounded by disco balls, leopard divans, and dolls with pink hair. Michael Angelo (yes, that's his real name) gave me a hug as we talked about the horrendous ordeal that has elapsed since we last met. Then he went to work. It was 5:30 PM on the 365th day of my Lost Year, and I was about to do something I had not done in that entire time.

I was getting my hair cut.

Twelve months have passed since I first learned I had an osteosarcoma in my left femur. During my recent quarterly check-ups, I received much good news. There are no signs of cancer in my bones or lungs. My prosthesis is growing nicely into my femur. As Dr. Healey said, "You are on your way to recovery. Truly."

He then added, "But we both know …"

On the sobering front, the chemotherapy has left me with neuropathy in the tips of several fingers. The fibular graft is not fusing to my femur in quite the way we hoped, and I may have to have more surgery to correct it this fall. And my leg is still a burden. We reach this one-year milestone with relief, if not champagne. My Lost Year is over, but my long road continues.

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Cancer Commons

Cancer Commons is a new patient-centric paradigm for translational medicine, in which every patient receives personalized therapy based upon the best available science, and researchers continuously test and refine their models of cancer biology and therapeutics based on the resulting clinical responses.

How to tell emergency room patients that they're dying. - By Joanne Kenen - Slate Magazine

On television, the emergency room patients beat the odds. Their hearts get shocked back to life. Their organs get sewn up. They awaken to a handsome young physician's dazzling smile.

In real life, one in 500 ER patients—200,000 a year—dies under the bright lights of the emergency rooms. Another 500,000—3 percent—die during hospital stays following emergency treatment. Countless patients learn, from a doctor they have never seen before and may never see again, that they have fatal diseases. Others get treated, aggressively and repeatedly, for dangerous flare-ups in conditions like heart failure or emphysema without anyone having the time or the skills to explain that the chronic disease they have been living with is now the chronic disease that they are slowly dying from, a scenario Atul Gawande explored in his recent New Yorker piece on what doctors can do when they can no longer cure.

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A Majority of Canadians Report They Are in Good Physical and Emotional Health, but Challenges With Wellness, Healthy Living and Chronic Disease Are on the Rise: Deloitte

Fifty-five per cent of Canadians rate their overall health as "excellent" or "very good" in 2011 - a decline from 2009 when 60 per cent said the same - and nearly two-thirds report high levels of emotional well-being, similar to two years ago. At the same time, Canadians are experiencing increased challenges as they try to adequately address wellness, healthy living and chronic disease. For example, over half of Canadians have been diagnosed with one or more chronic diseases. These are some of the findings of Deloitte's 2011 Survey of Health-care consumers in Canada: Key Findings, strategic Implications which surveyed over 2,300 adult Canadians to better understand the perspectives of Canadians as health-care consumers.

"While we note a decline compared to two years ago, the fact that a majority of Canadians continue to rate themselves as healthy is good news. Our survey shows we rank third in that self-assessment, just behind the U.S. (61 per cent) and the U.K. (56 per cent), and well ahead of the other nine countries we reviewed," says Mark Fam, Senior Manager, Deloitte National Health Services and lead author for the Canadian health consumer survey. "This is consistent with other findings in our study that indicate Canadians are generally satisfied with their health-care system, however we also see an increase in consumer demand for improvements to system performance and their access to health services that support their own wellness and care self-management."

But the new survey results also reveal major challenges, including increasing rates of chronic disease (52 per cent this year compared to 47 per cent in 2009), a development with significant implications in terms of health outcomes and income-generating capacity for many Canadians. "The number of Canadians giving high marks to their health climbs sharply (over 70 per cent) if we only look at those without chronic disease," Fam said. "In addition, one in seven Canadians now have responsibility for the care of family members or friends, an increase from 2009. Fam pointed out that this trend is growing and it represents major limitations on the caregivers' ability to earn income. "This is a challenge that continues to be a key element of the Canadian consumer health care experience," Fam said.

Now in its fourth year globally, and the second year for Canada, the 2011 survey continues to explore consumers' behaviours, attitudes, and unmet needs in six areas: wellness and healthy living; information resources; traditional health services; alternative health services; health insurance; health policy.

The new survey found that Canadians are experiencing a range of difficulties - from costs to information in order to fully navigate the system - in finding the resources they need to achieve effective self-care. As a result, survey respondents were in favour of innovations and solutions that help them manage their own care and that bring the health-care system as close as possible to the individual in order to meet evolving needs and expectations.

In commenting on these findings, Lisa Purdy, Partner, National Health Leader, Deloitte noted that the increasingly widespread use of preventive services - regular check-ups, screenings, supplements, nutritional foods - is a step in the right direction but that it needs to be enhanced with targeted encouragements such as tax-based incentives to promote healthy living. "Currently, women and older Canadians use preventive services the most, but younger Canadians indicate they would welcome new public tax models that reward healthy living," Purdy said.

She also emphasized the high interest shown by Canadians toward electronic tools that help manage their care and consolidate related information: Over 65 per cent of Canadians said they would favour having a government-provided electronic health record that could be used by themselves and their health providers; a similar number support medical devices that enable them to check their health condition and send information electronically to their doctor. "A strong majority of Canadians said they used the Internet in the past year for online banking, to purchase merchandise or reserve travel, so this is a trend our health-care system can adapt in order to meet the evolving needs of the population." Purdy also noted that consumers' concern over privacy and security of personal information is dropping: Fewer than a third of respondents say they are highly concerned about the security of their information stored online this year, compared to 34 per cent two years ago.

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Study Questions Important Heart Failure Trials -

A new study suggests Americans with heart failure may benefit less from recommended medications than patients in other countries.

The findings, which one doctor called "provocative," point to an emerging problem in drug development: As research becomes increasingly international, the outcomes may be less dependable in individual countries.

In the new work, researchers drive that point home for drugs known as beta blockers, which gold-standard tests have shown can extend the life of people with heart failure.

Breaking those drug trials down by country, it turns out U.S. patients didn't benefit appreciably, whereas the number of deaths during the trials fell by more than five in 100 in the rest of the world.

Lead researcher Dr. Christopher O'Connor, a cardiologist at Duke University Medical Center in Durham, North Carolina, said earlier studies had hinted of geographical differences in outcomes, but never as clearly as the new results.

Some five million Americans are living with heart failure, in which the heart fails to pump enough blood into the body. The condition is involved in about 300,000 deaths every year, according to the National Institutes of Health.

O'Connor's study, released Monday in the Journal of the American College of Cardiology, represents the first sweeping look at how beta blocker trials may come to different conclusions depending on the nationality of the participants.

He and his colleagues pooled results from so-called randomized controlled trials — the strongest experimental design available to doctors — that included U.S. patients.

They found four trials — the MERIT-HF, the COPERNICUS, the CIBIS-2, and the BEST trials — with a total of some 9,000 participants, nearly half of them American.

During those studies, beta blockers cut deaths among non-U.S. patients by 36 percent, while there was no statistically reliable drop among U.S. patients.

While that doesn't necessarily mean Americans don't benefit at all, it does question heart failure treatment guidelines, which often rely on international trials.

"It raises some concerns," O'Connor told Reuters Health. "If the patients have these differential treatment effects, we have to pay attention to it."

There aren't any clear-cut answers to why the outcomes vary by country.

It could be a question of different use of medications or devices to control heart failure, or it could be a chance finding because only one study included a large proportion of U.S. patients, the researchers write.

O'Connor said genetic differences might also be at play, because African Americans more often harbor a gene variant that makes them less responsive to beta blockers than whites. His study was funded in part by ARCA biopharma, which is developing a genetically targeted beta blocker treatment.

Whatever the explanation for the geographical variation, it's a problem drug developers would do well to tackle if they want their products to be approved by the U.S. Food and Drug Administration, according to O'Connor.

"This really goes beyond the beta blocker and heart failure story, it's about how we conduct clinical trials," he said. "I think the FDA gets nervous when they keep seeing these trends where, things may not look as good in the U.S."

As a case in point, for a while it appeared the FDA might not approve drugmaker AstraZeneca's new blood thinner Brilinta, because North American patients taking the drug did worse than patients on an older blood thinner -- which wasn't the case for European patients in the study.

AstraZeneca finally convinced the FDA the reason for the poorer results in North America might be related to the fact that aspirin interferes with Brilinta, and aspirin is more commonly used by heart patients in the U.S. than in Europe. The FDA approved Brilinta on July 21.

In an editorial in the same journal, Dr. Barry M. Massie, explains that many drug trials have now become "megatrials," including several thousand patients in different countries.

That's partly because current drugs and medical devices are so effective now that most advantages from new treatments will be miniscule. As a result, it requires lots of patients to show that potential benefits aren't just a result of chance.

While Massie, of the VA Medical Center in San Francisco, calls the new findings "provocative," he adds that American patients might still benefit from beta blockers.

"Most important, one cannot exclude the play of chance in these findings," he writes.