Doctor and Patient - Paying Doctors for Patient Performance

Despite his own solid“ranking,” my colleague found himself growing more and more disenchanted with these types of reimbursement programs.“It sounds like a great idea,” he said,“but it assumes that what I do or say always has a direct effect on my patients’ health.” He described a long-term patient he had seen earlier in the week; she had poorly controlleddiabetesyet failed to come into his office regularly in spite of his numerous requests.

“She just can’t afford to take that much time off from work,” he said, adding with a sigh,“Does that make me a worse doctor?”

For a little over a decade, amid calls for improved quality and greater transparency, insurance companies across the country have been“incentivizing quality”— shifting away from traditional fee-for-service reimbursement andturning to pay-for-performance programs. Based on the experiences ofhealth maintenance organizations in the mid-1990s with assessing quality, public and private third-party payers started applying many of the same evaluation criteria to individual physicians and linking reimbursement bonuses to similar, if not identical, clinical goals. The hope was that these well-established goals, such as regularmammogramsand Pap smears andscreening for colon cancerand highcholesterol, would not only improve care and cut costs over the long run but also provide payers and the public a standardized way to compare doctors and the care they deliver.

Health care experts applauded these early initiatives and the new focus on patient outcomes. But over time, many of the same experts began tempering their earlier enthusiasm. Inopinion piecespublished in medical journals, they havevoiced concerns about pay-for-performanceranging from the onerous administrative burden of collecting such large amounts of patient data to the potential worsening of clinician morale andwidening disparities in health care access.

But there has beenno research to datethat has directly studied the one concern driving all of these criticisms— that the premise of the evaluation criteria is flawed. Patient outcomes may not be as inextricably linked to doctors as many pay-for-performance programs presume.

Nowa study published this month in The Journal of the American Medical Associationhas confirmed these experts’ suspicions. Researchers from theMassachusetts General Hospitalin Boston and Harvard Medical School have found that whom doctors care for can have as much of an influence on pay-for-performance rankings as what those doctors do.

Drawing on the experiences of more than 125,000 patients, the researchers first ranked the doctors based on criteria commonly used in pay-for-performance reimbursement plans. While they found that doctors who took care of older or sicker patients tended to rank higher, presumably because of more frequent patient follow-up, the researchers also discovered that primary care practitioners who cared for underinsured, minority and non-English-speaking patients tended to have lower quality rankings than their counterparts.

Using statistical modeling, the researchers then attempted to rerank all the doctors after adjusting for differences in patient characteristics. When they factored patient race, ethnicity, primary language and insurance status into their physician evaluations, many of the original rankings changed, with doctors who worked in community centers— and therefore with more minority and non-English-speaking patients— being more likely to improve in ranking, often by more than 10 percentile points.

“Pay-for-performance can work,” said Dr. Clemens S. Hong, lead author and a general internist at the Massachusetts General Hospital,“but we need more sophisticated measures to make sure we are actually measuring physician quality.”

Addressing the discrepancies highlighted in the study will be challenging. Some health care experts, for example, have suggested paying for improvement rather than performance. Under this model, if over the course of a year doctors are able to increase the numbers of patients who obtain screening tests according to a standardized schedule, their reimbursement would increase.

But such a payment model comes with its own set of issues.“If your patient mammogram rate is 100 percent, there’s no way to improve,” Dr. Hong said.“And do we really want to pay doctors who have only half of their patients getting their mammograms done on time?”

Nevertheless, Dr. Hong and his co-investigators believe that their study only confirms the importance of research efforts focused on developing more sophisticated pay-for-performance measures.“It’s human nature to go to where the incentives are,” Dr. Hong said. Without specific assessment criteria, attributes that are currently measured indirectly or bypassed altogether, like the ability to communicate, build rapport and work with more vulnerable and challenging patients, risk being devalued or ignored.

“When you shine a light on certain measures, you take away from others that are also important,” Dr. Hong said.“Fee-for-service has already driven physicians away from primary care. If we don’t address patient differences, we may do the same thing with pay-for-performance.”

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A Needle (the Origin of a Deadly Malaria Strain) in a Dung Stack

And now it has yielded an unexpected gem: The most dangerous form ofmalariaoriginated in gorillas, not chimps, as had long been believed.

In and of itself, knowing that does nothing to help defeat malaria. But malaria experts were pleased to learn it— and it shows what wonders can be performed when you have 2,700 fecal samples in your freezers and a little imagination.

“There’s a lot you can do with ape scat,” Dr. Hahn said.“It’s worth its weight in gold.”

Dr. Hahn, a virologist at the University of Alabama at Birmingham, is an expert not in malaria but in S.I.V., or simian immunodeficiency virus, the precursor to the virus that causesAIDSin humans. But she has made deals with primate researchers all across Africa who collect fecal samples for their own projects, to have them take extras for her.

They go into vials with a special solution, called RNAlater, that preserves the nucleic acids of all the cells in the sample— which includes not only what apes eat, but cells sloughed off their gut linings, which contain all the things infecting them. She has systematically sequenced the genes of many of those infective agents: S.I.V., simian foamy virus,hepatitisand now malaria parasites.

Herstudywas published Thursday in Nature.

Knowing that gorillas are the source is not going to lead to a new drug, but it is reassuring in one important way, said Frank Collins, a malaria expert at theUniversity of Notre Dame. The human disease probably came from a mutant parasite that crossed over from a single gorilla thousands of years ago. That implies that if malaria is ever wiped out in humans, it is unlikely that it will ever be reintroduced from apes.

Reintroduction is not an idle threat. In 1932, the Rockefeller Foundation gave up on its 17-year campaign to eradicateyellow fever. Its scientists had realized that monkeys carried the same virus, so it would never be wiped out without wiping out monkeys, too.

Opening the freezer door and rescreening 1,827 dung samples from chimpanzees, 805 from gorillas and 107 from bonobos yielded several surprises, Dr. Hahn said.

Chimpanzees across Africa had various malaria parasites; bonobos, their closest relatives, did not. West African gorillas were infected, but East African ones were not. (The populations are kept separate by wide rivers like the Congo and by humans who chop down their jungle habitats and hunt them.)

Until recently, it had been believed that the falciparum strain of malaria— the most deadly kind, which can kill in 48 hours— came from chimpanzees, because the closest relative to it that had been found, the reichenowi strain, was common in chimps.

But previous surveys of ape malaria— which go back as far as 1907— have had obvious flaws, several malariologists said. Most sampled only a few apes, who were usually in captivity or in ape sanctuaries close to humans. One bonobo in one previous study, Dr. Hahn said, had parasites that not only were identical to human strains, but showed resistance to malaria drugs— which meant the bonobo must have caught them from a nearby human, not the other way around.

With the exception of 28 samples from a gorilla troupe habituated to humans,“all my samples are from the forest floor,” she said.

One researcher who sends her samples is David B. Morgan, a primatologist at Lincoln Park Zoo in Chicago and for theWildlife Conservation Societybased at theBronx Zoo, who studies gorillas and chimpanzees in the Goualougo Triangle of the Congo Republic. Dr. Morgan uses fecal samples to track hormone levels, parasites and even family relationships.

He does not try to get blood samples with“biopsydarts” or capture or tranquilize apes for study.

“We want to have as little impact on them as possible,” he said. (Primatologists now frown on the friendly banana-sharing that so endearedJane Goodallto readers of National Geographic decades ago.) He and his local trackers stay at least 35 feet from troupes they watch. They are vaccinated against diseases that apes can catch, take deworming pills and even defecate in bags that they carry back to camp so as not to risk infecting apes with human parasites, which has happened at other sites, he said.

Chasing samples is hard work, said Sabrina Locatelli, aState University of New Yorkprimatologist who works in Africa and collaborates with Dr. Hahn.

With colobus monkeys, who rain feces down from 70 feet up in the forest canopy, finding samples“means keeping your head up and your neck bent to spot them, so it can be painful,” Dr. Locatelli said.

With chimps and gorillas, she said, you follow them until they start building nests for the night, take a GPS point, go back to camp, get a few hours of sleep, and then come back early in the morning to look for samples, which are usually in or near the nest. With luck, the nest also has a few stray hairs, useful for DNA analysis.

Explaining her job to local officials is not easy either, she added.

Seven years ago, she said, when she was negotiating for permission to track bonobos in the Congo, she tried to explain what she wanted by showing park officials a vial of gel used for drying samples.

“It had these tiny blue beads in it,” she said.“People thought I was smuggling diamonds. They just would not believe me. They were saying‘Why would this tiny woman come so far to collect bonobo poop?’ ”

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Robert W. McCollum, Who Studied Viral Diseases, Dies at 85 - Obituary (Obit)

The cause washeart failure, said his daughter, Cynthia McCollum.

Most of Dr. McCollum’s research was done during his nearly three decades as a professor and later chairman of the epidemiology department atYale.

Working on a team at Yale led byDr. Dorothy M. Horstmannin the early 1950s, Dr. McCollum and his colleagues collected blood samples from people with polio and their families. They used some of the samples to isolate the polio virus and discovered that before it reached the spinal cord and paralyzed patients, it circulated in the blood.

That finding was a breakthrough in the understanding of how the virus causes the disease and formed a basis for the development of polio vaccines, which elicitantibodiesto block the virus before it enters the spinal cord.

In the late 1950s, while still at Yale, Dr. McCollum collaborated withDr. Saul KrugmanatNew York Universityto study hepatitis, which can causeliver diseaseand significantly contribute toliver cancer. Their team investigated the disease’s spread through blood transfusions by tracing its patterns in patients at theWillowbrook State Schoolon Staten Island.

The study drew controversy in the late 1960s after accusations that the team had used retarded children as human guinea pigs. But its chief critic in the New York Senate, Seymour B. Thaler of Queens, later conceded that the work had been conducted properly.

The research distinguished serum hepatitis, which is caused by the transfusions, from the more common form, infectious hepatitis, which is spread directly from person to person. That led to research by Dr. McCollum and Dr. Krugman that found that gamma globulin— antibodies collected from blood donors— can prevent hepatitis resulting from a blood transfusion.

Dr. McCollum was also a member of a research team that discovered that using blood from paid donors was risky because it tended to transmit hepatitis. The recommendation that blood banks stop using blood from paid donors has been widely adopted. Dr. McCollum was also on a team at Yale that discovered the viral cause of infectious mononucleosis.

“Bob made substantive contributions to our understanding and the prevention of viral diseases that affect millions of people globally,” Dr. John F. Modlin, a professor ofpediatricsat Dartmouth, said on Friday.

Robert Wayne McCollum Jr. was born on Jan. 29, 1925, in Waco, Tex., the youngest of four children of Robert and Minnie Sue McCollum.

He received his bachelor’s degree from Baylor in 1945, his medical degree from Johns Hopkins in 1948 and, 10 years later, a doctorate in public health from theLondon School of Hygiene and Tropical Medicine. He was hired as research assistant inpreventive medicineat Yale in 1951, but a year later was serving in Korea as a captain in the Army Medical Corps, assigned to a special MASH unit researching hemorrhagicfever.

Dr. McCollum left Yale in 1982 to become dean of the Dartmouth Medical School. In his nearly nine years as dean, he oversaw substantial increases in research financing and established eight new endowed chairs for the school’s faculty. He also played a central role in the creation of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H. Dr. McCollum retired as dean in 1990 and retired from teaching in 1995.

Besides his daughter, he is survived by his wife of 56 years, the former Audrey Talmage; a son, Douglas; and two grandchildren.

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Cases Without Borders - Weighing the Lives of Premature Babies in Haiti

It was the first week of May, almost four months after the earthquake, and the situation remained dire. Rubble was everywhere, many buildings were unusable, and all of the pediatric care was being given in tents. Supplies were sparse and unreliable.

The obstetricians at the General were on strike, and women in labor were being told to go elsewhere. But word had gotten out that there were American doctors at the hospital, and many patients simply refused to leave.

So it was on that rainy Sunday evening that there were six women in active labor in the emergency room. And soon one of them, in her late teens, gave birth to a tiny boy, just 2 pounds 3 ounces. A neonatologist on our team estimated that he was two months premature. (The mother claimed she hadn’t even known she was pregnant.)

Premature babies can get into a lot of trouble, and the smaller they are, the higher their risk of complications. They usually have difficulty maintaining a normal body temperature, losing heat to their surroundings faster than they can generate it. This is why they are kept in incubators until they are able to stay warm on their own. They are at high risk for infections, along with feeding and breathing problems.

Once the baby was born, we dried and swaddled him and started looking for a place where he could be cared for until he was stable enough to be sent home. There were no working incubators at the hospital, nor any free beds in the pediatric tents, and we had no luck finding incubators at otherhospitals.

Then an American physician at another medical camp told us that he had faced a similar situation some days before, and had built his own incubator—“MacGyver” style, as he put it. He suggested we do the same.

So that’s what we did. We took a cardboard box from the medical supply room, padded it with some surgical drapes and a blanket and found a desk lamp with a working bulb to serve as a source of heat. Voilà! Our youngest patient now had an incubator.

The next morning we tried to persuade the attending Haitian pediatrician to accept the baby to the pediatric tents.“Don’t be absurd!” she scoffed, as I recall.“A baby that small will not make it. He has no chance of survival, and we have no spare beds to waste.”

None of us felt comfortable arguing with her. Still, we knew that to send the baby to his mother’s tent city while he was still so vulnerable would be a death sentence. So we decided to keep him and his mother in the emergency room until a proper place could be found— understanding that we needed to find a solution before returning to Boston, as the group that would follow us did not include pediatricians qualified to treat complications of prematurity.

A baby bottle was found, along with clothes and diapers. The nurses taught his mother how to express milk into the bottle and to feed him. We’d been calling him“baby in the box”; now he became Jack, as in Jack in the box. He did very well, and his mother, after overcoming her surprise at his unexpected appearance, bonded with and cared for him devotedly.

Each day we pressed his case to the Haitian medical team, and each day we were turned down.“There is no room for him,” we were told, though there seemed to be beds for other children in the pediatric tents.

Finally, on Friday, we found an incubator for him at another hospital. We transferred him and his mother there, satisfied that we had gotten him through those first few days, but soberly aware of the odds he faced going forward. The next day we left for Boston.

Six weeks after our return, at an informal reunion, the neonatologist told us he had learned that Jack had been discharged home with his mother in good health, weighing five and a half pounds.

We were thrilled. Our stubbornness had paid off.

But our euphoria was tempered by a somber reality. Looking at the big picture, we had to concede that the Haitian doctors were probably right.

We were in Port-au-Prince, after all, not Boston. Surely the Haitians, acutely aware of what they could and could not do with the resources they had, would know better than a group of well-intentioned foreigners accustomed to the best equipment money can buy. Didn’t it make more sense to invest time, effort and scarce resources in a baby with a better chance of surviving?

Yet ultimately this was not an abstract discussion about the proper allocation of medical resources in an impoverished country, but a decision about the fate of a baby who was very much alive. He was our patient, and we were determined to give him the best possible care.

In the little-picture view, a life had been saved.

Dr. Dennis Rosen is a pediatric pulmonologist at Children’s Hospital Boston and an instructor at Harvard Medical School.

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F.D.A. to Severely Restrict Diabetes Drug Avandia

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Pill Drop-Offs Aid Effort to Clear Medicine Cabinets

From 10 a.m. to 2 p.m., people young and old delivered bag after bag of pills, including the types of powerful painkillers and anti-anxietydrugs that theDrug Enforcement Administration, which coordinated the program nationally, was hoping for. More than anything, the goal was to empty homes of legal but dangerous drugs that the authorities say are driving addiction and crime around the country.

“We’re getting a cocktail of just about everything,” said Milton Tyrrell, a special agent for the D.E.A. in Worcester who was supervising the collection in Russell Park.

Some of those who showed up did not want to identify themselves or discuss what brought them out, silently dumping their pills into boxes provided by the D.E.A. and hurrying off. Others said they were dropped off drugs that had belonged to relatives who were now dead, or elderly people who had let medicines pile up in their homes for too long.

“My 99-year-old aunt read about it in the paper and cleaned out all her medicine cabinets,” said Judy Hayden of Worcester, who brought mostly blood-pressure medications.“Thank God they’re doing this, because it seems like the whole city is on pills.”

Nationally, there were more than 4,000 drop-off locations– mostly police departments, but also sports complexes, big-box stores, strip malls and even a race track. In Worcester, Mr. Tyrrell listed Vicodin, Percocet and Lorazepam, which is taken for anxiety, among the drugs collected, as well as less potent medications that had been sitting in people’s bathrooms for decades.

Mary Whitehead Santos of Charlton, who dropped off two shopping bags full of pills, said her son, a physician, had talked her into doing so. Some of the drugs she deposited into the collection boxes had been prescribed in the mid-80s, she said.

“I kept hanging onto them thinking,‘They’ve got to be good for something,”’ she said, laughing.“My son kind of forced me out here, I guess. I’m not bringing the hard-core stuff that they’re looking for, but it’s good to finally be rid of it.”

In East Boston, a neighborhood of Boston that has struggled with addiction problems, the police station serving as a drop-off spot did not see much activity– possibly, officials there said, because the city only got the word out over the last week or two. Still, Joe Favale, a retired police officer, brought two bags that his girlfriend and a friend of hers had assembled. The bags contained three bottles of oxycodone, a highly addictive painkiller, as well as drugs formigraine headaches,asthma,acid refluxand other ailments.

“She wouldn’t throw it out because she was concerned for the environment,” Mr. Favale said of his girlfriend.“I myself was totally unaware that you shouldn’t throw the stuff away. When I have a couple of pills left over, I’m used to putting them down the garbage disposal.”

While the main goal of the take-back day was to reduce the volume of pills in households, law enforcement officials said the environmental benefits were important, too. The collected drugs will be incinerated instead of flushed down toilets, which can release them into the water supply.

Mr. Favale, who said he retired from the Boston Police Department in 2007, said he was taken aback by how big a problem prescription drug trafficking had become.

“The whole time I worked here in the 80s and 90s,” he said,“the concern was street drugs– reefer, cocaine, stuff like that.”

Matthew Murphy, assistant special agent in charge of the D.E.A.’s New England field division in Boston, said he had heard anecdotally that many sites in the region had an“overwhelming” response.

Mr. Murphy said that in Massachusetts, the National Guard would transport all of the drugs collected to five incineration sites and most would be destroyed by day’s end.

“We didn’t know what to expect,” he said.“But the public has been great; we had to go to trash bags in some cases because we ran out of boxes. We’ve had people show up and bring pharmaceutical products they’ve had around for 30 years.”

Mr. Murphy said he had heard about oxycontin and oxycodone, some of the most addictive opiate painkillers, being dropped off at several locations around New England. Even if only a small amount of that type of drug was collected, he said, the whole effort would be worthwhile.

“Any amount of that is great to get off the streets,” he said.“For us, that’s huge.”

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Vital Signs - A Good Massage Brings Biological Changes, Too

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Wright County Egg’s Founder Apologizes for Salmonella Cases

“What I mean by that is we were big before we started adopting sophisticated procedures to be sure we met all of the government requirements,” the egg producer, Austin J. DeCoster, said in testimony before a House Energy and Commerce subcommittee. He is the founder of an egg empire that has beenlinked over three decades to multiple deadly outbreaksof salmonella poisoning in many states.

Mr. DeCoster’s company, Wright County Egg, and another company, Hillandale Farms, recalled more than 500 million eggs last month after health officials traced salmonella bacteria that sickened more than 1,500 people to those companies.

A subsequent inspection by theFood and Drug Administrationfound that the barns of the egg producers were infested with flies, maggots and rodents, and had overflowing manure pits. Records unearthed by Congressional investigators showed that tests of Wright County Egg barns had shown the presence of toxic salmonella bacteria for years prior to the outbreak.

“We were horrified to learn that our eggs may have made people sick,” Mr. DeCoster, who is known as Jack, said in a shaky voice.“We apologize to everyone who may have been sickened by eating our eggs.”

The egg producer’s frequent run-ins with regulators over labor, environmental andimmigrationviolations at his operations have been well documented, and in his four-paragraph statement, Mr. DeCoster also accepted responsibility for mistakes that the company has made in complying with government regulations over the years.

Pictures taken at the DeCoster facilities of barns bursting with manure, manure flowing under barn doors, and barns with dead rodents, chickens and flies were shown at the hearing. Members of the committee expressed outrage that such conditions were allowed to continue.

“DeCoster farms have had warning after warning” for decades, said RepresentativeHenry A. Waxman, a California Democrat.“Yet they continue to raise chickens in slovenly conditions and to make millions of dollars by selling contaminated eggs.”

The hearing was briefly interrupted by two animal rights activists, who unfurled an anti-egg banner and repeatedly chanted:“All eggs kill!” The police escorted them from the room.

Democratic members of the committee denounced SenatorTom Coburn, a Republican from Oklahoma who has objected to a Democratic plan to bringfood safetylegislation to a vote.

“This is a public health imperative,” said RepresentativeEdward J. Markey, a Democrat from Massachusetts.“There must be some exceptions for Republicans in the Senate. They must release this bill so that we can protect millions of families.”

But Representative Michael C. Burgess, a Republican of Texas, said that Mr. Coburn’s objections had not prevented the legislation from being considered by the Senate. Mr. Burgess sought to read a statement from Mr. Coburn at the hearing, but RepresentativeBart Stupak, the chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, cut off Mr. Burgess’s microphone— an action that led to a sharp exchange of words between the lawmakers.

“I voted with you on the dang bill, I’ve worked with you on the dang bill,” Mr. Burgess said.“It is preposterous that the majority has conducted the hearing this way when he’s not the problem.”

And then, referring to Mr. Coburn, Mr. Burgess added:“He may become a problem if the majority leader brings it to the floor,” a remark that elicited laughter from the room.

Indeed, Republicans in the House and in the Senate have largely supported the legislation, and one reason was provided by Representative Bob Latta, a Republican of Ohio. Mr. Latta said he had sufferedfood poisoningtwice.“A lot of us go to a lot of events, and you eat what is put in front of you,” he said.

Carol Lobato, a 77-year-old retiree from Littleton, Colo., told the committee about a life-threatening Salmonella infection that she got from eating an appetizer of rattlesnake cakes from The Fort Restaurant in the town of Morrison, Colo. Her husband and grandson were also sickened, although not as badly.

“The infection wiped me out to the point that I could not function on my own or even get to the bathroom by myself,” she said. She spent five days in the hospital and still suffers routineindigestionand fatigue.“I lost eight pounds while being in the hospital, the only plus during this ordeal.”

Mr. DeCoster told the panel that Wright County Egg has for 10 years used employee training, additional monitoring and other steps that go beyond government requirements to ensure that his company’s eggs are safe.

“With all of these systems, we have made important strides, and I am proud of our work,” his statement says.

He does not explain, however, why those measures failed this year.

His son, Peter DeCoster, who is Wright County Egg’s chief operating officer, told the committee that the company failed to test its eggs for the presence of salmonella bacteria despite environmental tests that showed that his barns were contaminated because“our perception was that egg test results always would be negative,” according to his written testimony.

After the company’s farms were linked with the present outbreak of salmonella, however, the company sent 70,200 eggs, enough to represent each farm, for testing.

“These tests confirmed that Wright County Egg was producing eggs contaminated with” salmonella, Peter DeCoster said in his testimony.

In his testimony, Peter DeCoster promised to vaccinate all of his flocks against salmonella, a relatively inexpensive measure that can be highly effective in preventing the spread of the disease but that is still not required by the F.D.A.

“By focusing on our flocks, our feed and our worker biosecurity protocols we intend to demonstrate our commitment to the production of eggs that are high quality and safe,” he said.

He told the committee that the company suspects that contaminated feed was the culprit.

Inspection reports released by the F.D.A. in late Augustpointed to a feed milloperated by Wright County Egg as a potential source of the contamination. Officials said tests found salmonella in bone meal, a feed ingredient, and in feed given to young birds, which were raised to become laying hens.

In addition, the inspection reported birds roosting and flying about the mill. Nesting material was seen in parts of the mill, including the ingredient storage area and an area where trucks were loaded.

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Target Cancer - New Drugs Stir Debate on Rules of Clinical Trials

And when, last year, each learned that a lethalskin cancercalledmelanomawas spreading rapidly through his body, the young men found themselves with the shared chance of benefiting from a recent medical breakthrough.

Only months before, a new drug had shown that it could safely slow thecancer’s progress in certain patients. Both cousins had the type oftumoralmost sure to respond to it. And major cancer centers, including theUniversity of California, Los Angeles, were enrolling patients for the last, crucial test that regulators required to consider approving it for sale.

“Dude, you have to get on these superpills,” Thomas McLaughlin, then 24, whose melanoma was diagnosed first, urged his cousin, Brandon Ryan. Mr. McLaughlin’stumorshad stopped growing after two months of taking the pills.

But when Mr. Ryan, 22, was admitted to the trial in May, he was assigned by a computer lottery to what is known as the control arm. Instead of the pills, he was to get infusions of thechemotherapydrug that has been the notoriously ineffective recourse in treating melanoma for 30 years.

Even if it became clear that the chemotherapy could not hold back the tumors advancing into his lungs, liver and, most painfully, his spine, he would not be allowed to switch, lest it muddy the trial’s results.

“I’m very sorry,”Dr. Bartosz Chmielowski, the U.C.L.A. oncologist treating both cousins, told Mr. Ryan’s mother, Jan. He sounded so miserable that afternoon that Mrs. Ryan, distraught, remembers pausing to feel sorry for the doctor.

Controlled trials have for decades been considered essential for proving a drug’s value before it can go to market. But the continuing trial of the melanoma drug, PLX4032, has ignited an anguished debate among oncologists about whether a controlled trial that measures a drug’s impact on extending life is still the best method for evaluating hundreds of genetically targeted cancer drugs being developed.

Defenders of controlled trials say they are crucial in determining whether a drug really does extend life more than competing treatments. Without the hard proof the trials can provide, doctors are left to prescribe unsubstantiated hope— and an overstretched health care system is left to pay for it. In melanoma, in particular, no drug that looked promising in early trials had ever turned out to prolong lives.

PLX4032 shrinks tumors in the right patients, for a limited time. But would those who took it live longer? No one knew for sure.

“I think we have to prove it,” saidDr. Paul B. Chapman, a medical oncologist atMemorial Sloan-Kettering Cancer Centerwho is leading the trial.“I think we have to show that we’re actually helping people in the long run.”

But critics of the trials argue that the new science behind the drugs has eclipsed the old rules— and ethics— of testing them. They say that in some cases, drugs under development, PLX4032 among them, may be so much more effective than their predecessors that putting half the potential beneficiaries into a control group, and delaying access to the drug to thousands of other patients, causes needless suffering.

“With chemotherapy, you’re subjecting patients to a toxic treatment, and the response rates are much lower, so it’s important to answer‘Are you really helping the patient?’ ” saidDr. Charles L. Sawyers, chairman of human oncology at Sloan-Kettering.“But with these drugs that have minimal side effects and dramatic response rates, where we understand the biology, I wonder, why do we have to be so rigorous? This could be one of those defining cases that says,‘Look, our system has to change.’ ”

Dr. Richard Pazdur, director of the cancer drug office at theFood and Drug Administration, said in a recent interview that the new wave of drugs in development— especially for intractable cancers like melanoma— might require individual evaluation.“This is an unprecedented situation that will, hopefully, be increasingly common, and it may require a regulatory flexibility and an open public discussion,” he said.

And doctors say that for them, the new wave of cancer drugs is intensifying the conflict between their responsibility to their patients and their commitment to gathering scientific knowledge for generations of the critically ill.

Of course, no single pair of patients can fairly represent the outcomes of a trial whose results are not yet known. Rather, the story of Thomas McLaughlin and Brandon Ryan is one of entwined paths that suddenly diverged, with a roll of the dice.

At times beseeching and belligerent, Mr. McLaughlin argued his cousin’s case to get the new drug with anyone he could find at U.C.L.A.“Hey, put him on it, he needs it,” he pleaded. And then:“Who the hell is making these decisions?”

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Global Update - Global Warming May Help Cut Cases of Plague

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The Mechanisms of a Controlled Trial

Phase I, an initial study in a small group, establishes whether a treatment is safe and at what dosage.

Phase II, in a larger group, evaluates the effectiveness of the drug and determines common short-term side effects and risks.

Phase IIIexpands the evaluation, usually through acontrolled trialwhere the drug is tested against standard treatments to evaluate benefits and risks, differences in response rates, and toxicity. One group of participants gets the experimental drug, and the control group receives a placebo or standard treatment (in the trial for themelanomadrug PLX4032, the control waschemotherapy). Participants are randomly assigned to a treatment group.

In a typical“blind” study, neither patients nor researchers know which participants are receiving the experimental drug. The trial of PLX4032 wasunblinded, meaning doctors told patients whether they were assigned to the control arm.

Phase IVtakes place after the drug has been licensed and marketed, to determine optimal use.

SOURCE:ClinicalTrials.gov

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Senate Bill Addressing Food Safety Is Stalled

Nearly two years have passed since Shirley Almer’s death. In that time,food contaminationinvolving chocolate chip cookie dough and eggs has sickened thousands more.

But the Senate has still not acted to fix many of the flaws in the nation’s food safety system— although a bill to do so has broad bipartisan support, is a priority for the Obama administration and has the backing of both industry and consumer groups. The House passed its version of the bill more than a year ago.

“It’s so frustrating,” said Mr. Almer, of Savage, Minn.“I don’t even know who to blame.”

The blame lies with a tight Senate calendar, a stubborn senator from Oklahoma and an unusual coalition of left- and right-wing advocates for small farmers who have mounted a surprisingly effective Internet campaign. Their e-mail messages have warned, among other untruths, that the bill would outlaw organic farming.

Dr.Margaret Hamburg, commissioner of food and drugs, said in an interview that she was still confident the legislation would pass, although she confessed to being bewildered by the lengthy battle to schedule a vote.

“This is a historic opportunity,” Dr. Hamburg said.“This legislation would provide F.D.A. with important resources and authorities that we really need to be able to do our important job.”

The latest hope for the bill’s advocates was that SenatorHarry Reidof Nevada, the Democratic leader, would schedule a vote on the bill this week. But the Senate calendar is full of measures that need to be passed before members leave in October to campaign, so Mr. Reid sought a routine agreement to limit debate on the measure.

SenatorTom Coburn, Republican of Oklahoma, refused, saying that the powers granted to the F.D.A. in the bill would have financial costs, and that those costs needed to be offset by spending reductions.

Mr. Coburn also expressed doubts that expanding the authority of the F.D.A. would“result in improved food safety,” said John Hart, his spokesman.

Mr. Reid responded Thursday, saying,“In light of recent events like the egg recall in Iowa, it is unconscionable that Senator Coburn and his Republican colleagues are putting politics ahead of a common-sense, bipartisan bill to ensure that the food products our families consume every day are safe.”

So the legislation may have to wait until the Senate’s lame-duck session after November’s elections, when it still could die. Many of the gaps in the nation’s food protection system that the bill would close became apparent in the recent recall of 500 million eggs after more than 1,500 people became ill.

For instance, the F.D.A. never inspected the Iowa egg facilities at the center of the recalls. Even if it had, the agency would not have had the power to order that their eggs be recalled despite conditions it later found to be filthy. And until recently, producers were not required to ensure that their eggs were safe.

By requiring regular inspections of high-risk facilities, providing the F.D.A. with the power to order recalls and demanding that food makers create plans to process food safely, the proposed legislation would change many of the circumstances that led to the illnesses.

But in a little-known footnote to the egg recall, inspectors from the Agriculture Department regularly visited the Iowa egg facilities to grade the eggs and noted unsanitary conditions but never told the F.D.A. about them. That kind of poor communication and coordination between the government’s main food agencies is routine, and the legislation stalled in the Senate would do little to correct them.

Nonetheless, mainstream consumer advocates and major food makers are nearly united in calling for the legislation’s passage. Just a few years ago, many manufacturers were opposed to expanding the F.D.A.’s food authority. But when a relatively small producer sold contaminated spinach several years ago, the entire industry’s crop was thrown out, resulting in huge, industrywide losses. And once a food contamination scare affects a product, sales are slow to return to normal.

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Patient Money - Tax Credit Will Help Small Businesses With Health Premiums

But premium increases in recent years were so astronomical that health care costs had been eating up 30 percent of the store’s revenue, about $78,000 a year.“That’s just not sustainable for any business,” Ms. Burton said.

Last year, she seriously considered dropping health care coverage altogether or shutting the bookstore’s doors. But relief arrived in the form of the new health care law. Beginning this year, the law provides generous tax credits to small businesses struggling to maintain health coverage.

After sorting through the somewhat complicated requirements, Ms. Burton discovered her store was eligible for the full credit, which will give the business a rebate of $21,000 this tax year. So for now, the King’s English is still in business, and Ms. Burton and her employees have kept theirinsurance.

“These people really need their insurance, and I’m right there with them,” Ms. Burton said.“I have a son with special needs, and I don’t know what would happen to him or us without this insurance.”

Just over one-third of Americans work for small businesses with fewer than 100 employees. If you’re one of those workers, you know that very few small companies offer comprehensive health insurance— or for that matter, any health insurance at all. Even when they do, premiums can be prohibitively expensive, because small businesses can’t negotiate the discounts given to large group plans.

To help close that gap, the government this year is offering a tax credit to companies with fewer than 25 full-time workers and average wages of less than $50,000 a year. To qualify, employers must pay at least 50 percent of their employees’ health care premiums.

Small businesses with 10 full-time employees or fewer earning an average of $25,000 or less are eligible for the largest credit, 35 percent of their health insurance premium costs. Companies with larger numbers of employees earning more receive smaller credits on a sliding scale.

Not every small shop will qualify for the credits, but a recent study by two advocacy groups, Small Business Majority and Families USA, estimated that 84 percent of small businesses were eligible. (This includes firms that currently offer some type of coverage.)

One health care foundation, the Commonwealth Fund, said ina recent reporton small business and the new health law that up to 16.6 million workers were employed by eligible companies.

“The tax credit and other provisions in the health care law are designed to repair the weaknesses in the health care system and bring small employers on a level playing field with large companies,” said Sara R. Collins, vice president for affordable health insurance at the Commonwealth Fund.

If you own a small business, it might pay to familiarize yourself with the new provisions in the health care law. They may convince you that you can afford to offer health insurance or keep your existing policy in place.

If you’re an employee at a small company, you could learn the details yourself and make sure your employer is ready to take advantage of the coming changes. Entrepreneurs are busy and not always plugged into these kinds of administrative changes. Your input may mean the difference between getting insurance or going without.

CREDIT QUALIFICATIONSA simple worksheeton the I.R.S. Web site helps to show whether your firm has the proper number of employees and average salaries to qualify for the new tax credits. The site also has clear explanations of how the credits work.

There is no application process; the business owner simply files one additional form with the company tax return. Start pulling together the figures now, though. The tax credit begins in the 2010 tax year, so the payoff will come as soon as next January, said John Arensmeyer, chief executive of Small Business Majority.

The tax credit is set to expire in 2016, on the assumption that by then most small businesses will have made the transition to the insurance exchanges, where policies will be more affordable and premium costs will be the same for all participants.

DROPPED COVERAGEEffective Sept. 23, insurance companies will no longer be permitted to deny coverage to people simply because they have gotten sick.

In the past, some insurers tried to find errors in a customer’s application, then used them as an excuse to deny payment for a large claim. Employees of small businesses were particularly vulnerable, said Mr. Arensmeyer.

The new law makes this practice illegal.

PREVENTIVECAREStarting in September, all new health care plans must pay for preventive care, including physicals and other wellness programs. This extra care may mean extra costs for small-business owners.

Fortunately, the government has set aside $200 million in grant money over five years to help small employers provide programs likesmoking cessation,nutrition, physical fitness andstress management.

“Wellness programs are easy for large companies likeSafewayorI.B.M., but a small firm doesn’t have the bandwidth to absorb the administrative costs,” said Mr. Arensmeyer. Companies with fewer than 100 employees may apply for grants, which are administered by the federalDepartment of Health and Human Services.

AFFORDABLE OPTIONSSmall businesses will have even greater tax benefits once the new state health insurance exchanges are up and running in 2014. The maximum tax credit will increase to 50 percent at that time— but companies must buy insurance through the exchanges to be eligible.

What’s more, insurance companies will not be able to charge more in premiums based on sex, age or health status. In the past, small companies with older or ill workers were hit with huge premium increases in their company plans, said Ms. Collins of the Commonwealth Fund.

That’s what happened to Ms. Burton. Three employees, including Ms. Burton, have entered their 60s in the last few years. They are charged higher premiums than other employees because of their age.. As a result, health insurance costs for the company, already on the rise, have skyrocketed.

One of the older employees ended up relocating.

“We were really skating on thin ice,” said Ms. Burton.“If she hadn’t left, I’m not sure we would have made it through last year.”

The new law should help prevent large premium increases. Plus, small companies that have had trouble finding or deciding on an affordable plan should find the job easier with the streamlined exchange options.

“Currently small businesses pay 18 percent more for the same coverage that large businesses have,” Mr. Arensmeyer said. The new law, he believes, will go a long way toward closing that gap.

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Doctor and Patient - Teaching Doctors About Food and Diet

“Should I takevitamins?”

“What do you think of thisdiet?”

“Is yogurt good for me or not?”

Each and every time someone posed such a query, I became immediately cognizant of one thing: the big blank space in my brain. After all, even with medical school acceptance in hand, I was no more a doctor than they were.

But I also soon realized that many of their questions had nothing to do with medications or operations, or even diseases. With all the newspaper and television reports about newly discovered carcinogens and the latest diets and miracle nutrients, what my friends and acquaintances really wanted to know was just what they should or should not eat.

Years later, as a newly minted doctor on the wards seeing real patients, I found myself in the same position. I was still getting a lot of questions about food and diet. And I was still hesitating when answering. I wasn’t sure I knew that much more after medical school than I did before.

One day I mentioned this uncomfortable situation to another young doctor.“Just consult the dietitians if you have a problem,” she said after listening to my confession.“They’ll take care of it.” She paused for a moment, looked suspiciously around the nursing station, then leaned over and whispered,“I know we’re supposed to know about nutrition and diet, but none of us really does.”

She was right. And nearly 20 years later, she may still be.

Research has increasinglypointed to a link between the nutritional status of Americansand the chronic diseases that plague them. Between the growing list of diet-related diseases and aburgeoning obesity epidemic, the most important public health measure for any of us to take may well be watching what we eat.

But few doctors are prepared to effectively spearhead or even help in those efforts. In the mid-1980s, theNational Academy of Sciencespublisheda landmark report highlighting the lack of adequate nutrition educationinmedical schools; the writers recommended a minimum of 25 hours of nutrition instruction. Now,in a study published this month, it appears that even two and a half decades later a vast majority of medical schools still fail to meet the minimum recommended 25 hours of instruction.

Researchers from theUniversity of North Carolinaat Chapel Hill asked nutrition educators from more than 100 medical schools to describe the nutrition instruction offered to their students. While the researchers learned that almost all schools require exposure to nutrition, only about a quarter offered the recommended 25 hours of instruction, a decrease from six years earlier, when almost 40 percent of schools met the minimum recommendations. In addition, four schools offered nutrition optionally, and one school offered nothing at all. And while a majority of medical schools tended to intersperse lectures on nutrition in standard, required courses, like biochemistry or physiology, only a quarter of the schools managed to have a single course dedicated to the topic.

“Nutrition is really a core component of modern medical practice,” said Kelly M. Adams, the lead author and a registered dietitian who is a research associate in the department of nutrition at the university.“There may be some pathologists or other kinds of doctors who don’t encounter these issues later, but many will, and they aren’t getting enough instruction while in medical school.”

For the last 15 years, to help schools with their nutrition curriculum, the University of North Carolina has offered a series of instruction modules free of charge. Initially delivered by CD-ROM and now online, the program,Nutrition in Medicine, is an interactive multimedia series of courses covering topics like the molecular mechanism ofcancernutrition, pediatricobesity,dietary supplementsand nutrition in the elderly.

“Physicians have enough barriers trying to provide their patients with nutritional counseling,” Ms. Adams said.“Inadequate nutritional education does not need to be one of them.”

Ms. Adams and her colleagues believe that the fully developed online curriculum helps address two issues that frequently arise: the relative dearth of faculty in a medical school with appropriate expertise and the lack of time in an already packed course of study.

The flexibility of the online program has already helped students at theTexas TechSchool of Medicine in Lubbock. Medical school teachers at Texas Tech, which has one of the best nutrition education programs in the country, were finding that they had difficulty maintaining the intensity and quality of instruction once more senior medical students began working inhospitalsscattered across the school’s widely dispersed campuses. Students at a hospital that had the luxury of a trained faculty member, for example, would be immersed in adiabetesworkshop that involved“becoming diabetic” for a week and regularly checking blood sugar readings and self-administering“insulin” through a needle and syringe, while students at another hospital would be left with no instruction at all. The online Nutrition in Medicine course allowed all the students to continue learning about diet and counseling patients despite their disparate locations and resources.

“We didn’t have to reinvent the wheel at other campuses when we already had these online courses that are so well done,” said Katherine Chauncey, a registered dietitian and a professor of clinical family medicine at Texas Tech.

More recently, Ms. Adams and her colleagues have begun working ononline nutrition education programs geared toward practicing physicians.“Many of them are realizing that their training wasn’t adequate enough to make them feel comfortable counseling patients,” Ms. Adams said. Short, focused and relatively easy to navigate, these courses are meant to help fill in those gaps in knowledge for older doctors. Eventually, practicing physicians may even be able to earn continuing medical education credits, a requirement of many hospitals, state licensing boards and specialty boards.

“It’s extremely difficult to get people to change their diets and their habits around food,” Ms. Adams said.“Anything that improves a doctor’s confidence and skill set will go a long way in helping patients.”

Added Dr. Chauncey:“You can’t just keep writing out script after script after script of new medications when diet is just as important as drugs or any other treatment a patient may be using.”

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Suit on Health Care Bill Appears Likely to Advance

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Recipes for Health - Corn and Green Bean Salad With Tomatillo Dressing

For the dressing:

1/4 pound fresh tomatillos, husked

1 serrano chili, seeded for a milder dressing and coarsely chopped

1 tablespoon fresh lime juice

10 cilantro sprigs

1 tablespoon chopped onion, soaked in cold water for five minutes, drained and rinsed

1 garlic clove, peeled

3 tablespoons extra virgin olive oil

Salt to taste

For the salad:

Kernels from 2 ears corn

3/4 pound green beans, trimmed and cut in 2-inch lengths (about 3 cups)

1 large or 2 medium tomatoes, cut in 1/4-inch dice

4 radishes, cut in half lengthwise then sliced thin in half-moons

2 tablespoons minced chives

Lettuce leaves for the platter or bowl

1/4 cup crumbled queso fresco (1 ounce)

1.Preheat the broiler. Cover a baking sheet with foil and place the tomatillos on top, stem side down. Place under the broiler at the highest rack setting and broil two to five minutes, until charred on one side. Turn over and broil on the other side for two to five minutes, until charred on the other side. Remove from the heat and transfer to a blender, tipping in any juice that may have accumulated on the baking sheet. Add the chili, lime juice, cilantro sprigs, onion, garlic and olive oil to the blender and blend until smooth. Taste and adjust salt, and set aside.

2.Steam the corn kernels (or steam the entire ear, then cut the kernels off) and beans above one inch of boiling water for five minutes, until tender. Remove from the heat, refresh with cold water and drain on paper towels. Place in a bowl and toss with the tomato, radishes, chives and the dressing. Line a platter or wide bowl with the lettuce leaves, top with the salad, sprinkle on the crumbled cheese and serve.

Yield:Serves six generously.

Advance preparation:You can prepare the dressing and the salad several hours before serving, but don’t toss together until ready to serve. Refrigerate in separate bowls.

Nutritional information per serving:129calories; 8 grams fat; 1 gramsaturated fat; 2 milligramscholesterol; 14 gramscarbohydrates; 3 gramsdietary fiber; 19 milligrams sodium (does not include salt added during preparation); 3 grams protein

Martha Rose Shulman can be reached atmartha-rose-shulman.com. Her new book,“The Very Best of Recipes for Health,” was recently published by Rodale Press.

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18 and Under - School Refusal May Signal Physical or Emotional Trouble

Asore throat. Acoughso bad it kept him up all night. Another sore throat. A weekend visit to the emergency room.“Can I just get a note for the school?” his anxious mother would ask, and I would print it out and sign it.

But I didn’t grasp the extent of the situation until I got a call from the school nurse. If my patient missed another couple of days, she told me, he would be required by law to repeat first grade; the school year wouldn’t count. Would I please make sure I was giving him all those absence notes for a very good reason?

School refusal— any kind of absenteeism, fromphobiato truancy, that can be traced to the child’s own actions and wishes— is at the very intersection of education,psychologyandpediatrics. So it should be a good place for teachers,psychologistsand pediatricians to work together.

In fact, though, as the pediatrician who should have been the first to notice the problem, I was pretty clueless. My patient was an anxious and somewhat quirky child— I had talked to his mother about the possibility of a developmental evaluation, but we had agreed to wait and watch him in first grade. In fact, he was avoiding things in school that made him uncomfortable— interactions on the bus, jostling on the playground. He was avoiding academic moments where someone might find out he was struggling. And he was sticking close to his mother, so she could keep an eye on him and he could keep an eye on her.

Dr. Helen Egger, a child psychiatrist and epidemiologist at Duke University Medical Center, has studied the relationship between school refusal and conditions like depression andanxiety disorder. About a quarter of the childrenin her studywho showed school refusal behavior hadanxietyproblems. And as she told me,“it can be as strongly associated with depression as with anxiety.”

As a developmental-behavioral pediatrician at Johns Hopkins, Dr. Barbara Howard sees the more extreme cases of school refusal— among them, children whose school days are complicated by medical or learning problems. Some have difficulty from the first day of kindergarten because they aren’t ready to separate from their parents or because they are particularly anxious, she told me; they need help with initial adjustment.

“We should be careful not to set kids up who are anxious,” she said.“Make sure they can take their favorite fuzzy bear with them.”

And when children are anxious about returning to school, she continued, it’s especially important to ask them whether there are particular problems— a bully, a bathroom with no doors on the stalls. Even so, finding and fixing such a problem doesn’t necessarily confer the coping skills an anxious child needs to feel comfortable in school.

The taxonomy of school refusal— from school phobia to truancy— is complicated, and it has changed over time. Experts now tend to break down the behaviors by motivation.

Children may avoid school because they are trying to avoid negative feelings, like anxiety and depression, or negative experiences, like exams or troubling social interactions. On the other hand, they may be pursuing some positive reward— a parent’s attention, the chance to play video games all day or, for older kids, more illicit pleasures.

And there is overlap, the experts point out: a child who misses a great deal of school for reasons that look like truancy may become increasingly anxious— and embarrassed— about going back. In fact, missing school intensifies both the academic pressures and the social pressures that are waiting when a child returns, setting up a dangerous cycle in which the more you’re absent, the more you want to stay out.

The important distinction is in the response.“If you have a child that’s very anxious, you’re going to use a lot of anxiety management techniques,” saidChristopher A. Kearney, professor and director of clinical training in the department of psychology at theUniversity of Nevada, Las Vegas. With the reward-seeking group, he continued,“increase incentives for going to school and supervision outside of school.”

If we look at school as children’s work, then absenteeism becomes a kind of red flag, a signal that something has gone wrong in a child’s health or emotional life, or within the family or in the school itself.

It’s the pediatrician’s job, of course, to make sure vague physical complaints don’t actually signal an undiagnosed disease. School absenteeism can be a marker for poor medical care, or for inadequate management of a chronic illness, likeasthma.

“It’s not a diagnosis, school refusal,” Dr. Egger said.“It’s not a disorder; it’s a symptom.” But it’s an important symptom, with consequences that can be harsh. It should send parents— and pediatricians, educators and psychologists— looking for ways to help.

The pediatrician, she continued, should ask,“Is this a primary issue around attending school that we can just address, or is this an indication of another disorder: anxiety, depression, sleep, somatic complaints?”

My patient didn’t have to repeat his grade. The school agreed to let him make up some of the time he had missed. And, he got the learning evaluation he needed, followed by classroom interventions that made a significant difference in his ability to learn. (I also suggested individual counseling for mother and son. He went, but missed many appointments; she refused.)

So what started with vague sore throats and nagging coughs ended with a list of important tasks for a long cast of characters. The school environment had to change. The child had to learn new coping skills. His mother had to change her approach to minor illnesses.

And his pediatrician had to wise up.

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Tax Provision of Health Care Law Opposed by Many in Both Parties

To improve compliance, the law requires businesses to file a 1099 tax form identifying anyone to whom they pay $600 or more for goods or merchandise in a year. Businesses will also have to send copies of the form to their vendors, suppliers and contractors.

Businesses denounce the requirement, and even the national taxpayer advocate at theInternal Revenue Service, Nina E. Olson, said the reporting burden might“turn out to be disproportionate as compared with any resulting improvement in tax compliance.”

The White House is nervous about a repeal, fearing that it could set a precedent for rolling back other unpopular features of the law. Moreover, the reporting requirement is expected to lead to a significant amount of revenue— $17 billion over 10 years— to help pay for the expansion of coverage and other health initiatives. It is unclear whether Democrats and Republicans can reach agreements on repealing the provision and on finding a way to offset the loss of money.

Under the law, businesses will be required to report purchases of items like office equipment, food and bottled water, gasoline, lumber and plumbing supplies if payments to any vendor in the course of a year total at least $600. They will, in many cases, also have to report payments for things like travel and telephone and Internet service.

The annual reports must include the vendor’s address and taxpayer identification number.

The Congressional Joint Committee on Taxation and some lawmakers say the reporting requirement will induce businesses to pay more of the tax they owe— just as individuals are more likely to pay tax on dividends and interest income knowing that such information has been reported to the I.R.S. by mutual funds, banks and other corporations.

Two Republicans, Representative Dan Lungren of California and SenatorMike Johannsof Nebraska, are leading efforts to repeal the reporting requirement.

In late July, 239 House Democrats voted for repeal, but the bill did not get the two-thirds majority needed for approval under the expedited procedure used then.

The Senate is scheduled to vote on a repeal, as an amendment to a small-business jobs bill, soon after it reconvenes this week.

President Obamastrongly supports the jobs bill, which would provide loans and tax breaks to small businesses. But he has not embraced a repeal of the reporting requirement.

Most Republicans want a full repeal. In a recent speech, the House Republican leader, RepresentativeJohn A. Boehnerof Ohio, said the“1099 mandate” showed how the health care law could“wreak havoc on employers and entrepreneurs.”

Republicans also see the new requirement as an example of the intrusive role they say the I.R.S. will play in enforcing the health care law, including its requirement for most Americans to carry insurance.

Senate Democratic leaders prefer a proposal by Senator Bill Nelson, Democrat of Florida, that would reduce the scope of the reporting requirement. Under Mr. Nelson’s plan, businesses with 25 or fewer employees would be exempt from the new requirement, and the reporting threshold for larger businesses would be set at $5,000, rather than $600.

Mr. Nelson says more than 90 percent of companies would qualify for the small-business exemption under his proposal.

But Mr. Johanns said this“half-measure” was unacceptable.

Stephanie Cathcart, a spokeswoman for the National Federation of Independent Business, said many businesses would still have to keep track of their payments to each vendor to see if they exceeded the $5,000 threshold for the year.

SenatorBlanche Lincolnof Arkansas, a vulnerable Democrat running for re-election, voted for the health care law but supports Mr. Johanns’s effort to repeal the reporting requirement.

“We must not create unnecessary burdens for small businesses that serve as the backbone of Arkansas’s economy,” Mrs. Lincoln said.

To help make up for the loss of revenue, Mr. Johanns would cut spending from a new prevention and public health fund. Mr. Nelson would increase taxes on big oil companies.

In the House, RepresentativeScott Murphyof New York has led the Democratic efforts to repeal the reporting requirement.

“This 1099 reporting was a well-intentioned provision to try to catch people who were cheating on their taxes,” Mr. Murphy said.“But it has some unintended consequences and could be a huge hassle for a lot of small businesses.”

The reporting requirement was in the health care overhaul bill unveiled in mid-November by the Senate Democratic leader,Harry Reidof Nevada. But it drew little attention at the time— it was one of more than 15 revenue-raising measures in the bill— and many lawmakers were apparently unaware of it when they voted for final passage of the legislation.

Four Democratic senators who voted for the bill have sent a letter to the I.R.S. expressing concern that“the new requirements may place a hardship on small businesses.” The letter was signed byEvan Bayhof Indiana,Mark Begichof Alaska,Ben Nelsonof Nebraska andJeanne Shaheenof New Hampshire.

For years, lawmakers have complained about the gap between taxes owed and taxes paid voluntarily. Reducing this gap is a top priority for some lawmakers, but resistance to the new reporting requirement shows how difficult it is to achieve that goal.

In a report on the tax gap, the I.R.S. said that“there is a serious problem with underreporting” of income by sole proprietors, who own unincorporated businesses by themselves. The Bush administration twice urged Congress to help close the gap by expanding information-reporting requirements.

Ms. Olson, the independent taxpayer advocate, said the new reporting requirement would apply to over 38 million businesses, including 26 million sole proprietorships and 2 million farms.

“The I.R.S. will face challenges making productive use of this new volume of information reports,” Ms. Olson said.

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Conversations - Views of Health Care Economics From a C.E.O. Named Bush - Question

Based in Watertown, Mass., Athenahealth offers a suite of administrative services for medical practices. It collects payments from insurers and patients, and it manages electronic health records and patient communication systems. All of this is done remotely through the Internet— or“in the cloud,” as Mr. Bush puts it. Doctors don’t have to install or manage software or pay licensing fees; instead, Athenahealth keeps a percentage of the revenue.

Lately, Athenahealth’s stock price has been hammered by news of aninternal accounting auditandmissed earnings expectations. By July its shares had fallen by more than half from their January high. (They have since reversed some of that decline.)

Even so, the company’s sales have grown substantially over the last couple of years. While the bill collection service still accounts for most of the sales, the company’s fastest-growing business has been its electronic records segment, which has benefited from provisions in the 2009 stimulus law and this year’s health care overhaul.

What follows is a condensed version of a conversation with Mr. Bush about how he built a small medical practice into a national enterprise with nearly 1,200 employees, and how the new health care law is likely to affect businesses— small firms as well as his own.

Q.Athenahealth got its start when you purchased a birthing practice in California back in 1997. But you’re not a doctor— why did you buy it?

A.You know, Bush family noblesse oblige. I wanted to take advantage of all this education and support I’ve had and do well by doing good, and health care seemed like a place that no one else in my family had been much. A new approach to health care seemed to me to be the oil fields of 1997.

Q.So what led you into the administrative services business?

A.I ran into all of the problems that medical practices ran into, all of which were unrelated to medical care. I couldn’t get my claims paid, I couldn’t make payroll because of all of these ridiculous regulatory and insurance rules that were changing all the time and were very esoteric, and the technical infrastructure to connect and move around was incredibly poor.

We had 13 little offices up and down San Diego County, and they were running up against scale-based obstacles, things that would need real management infrastructure and capital to do properly. So we built a little Web site for ourselves called Athenanet, and pretty soon all the doctors in the neighborhood wanted to be on Athenanet.

In fact, when we were trying to raiseventure capitalto go do more birthing centers, and it wasn’t happening, one of the venture capitalists said in passing that he would give me $11 million for an unlimited license to Athenanet {laughs}. And I think our pre-money valuation for the whole company was $7 million. It was as if a budding, small airline wakes up to find that they invented theSabresystem.

Q.Your revenue has grown 40 percent in each of the last two years, from $98 million to $189 million—

A.Don’t you love it?

Q.Well, not as much as you do.

A.And yet, the Street hates me. I don’t know.

Q.What’s going on in the health care industry to deliver that kind of growth to you?

A.We are a disruptive technology. We are the only cloud-based service in an industry segment full of sclerotic, enormous, personality-free corporations that have been in business making 90 percent margins doing nothing for decades and decades.

Q.What keeps other companies from building cloud-based systems?

A.For software companies, the biggest barrier to entry is that they give up their business model. Those companies would get hammered on Wall Street if they started selling a service that they have to deliver at a loss for five years. In terms of new entrants, there are two things that we’ve done that would take a good decade to replicate. One, we’ve built out the health care Internet. We’ve been building connections into insurance companies and laboratories and hospital medical records for years and years and years.

And the other barrier to entry is that rules engine. Every time a doctor anywhere in the country gets a claim denied, we have analysts ask theFive Whys. When we get to root cause, we write a new rule into Athenanet and from that day on, no other doctor gets that particular denial from that particular insurance company ever again. We now know of 40 million ways that a doctor can have a claim denied in the United States. The average practice has to rework about 35 percent of their claims, and we only have to rework about 5 percent of ours.

Q.What’s the prognosis for bill collecting underhealth care reform?

A.Well, there’s going to be new connectors and a whole series of new insurance products that will be managed by the states’ health insurance commissioners. And the law provides for every state to do all of these its own way, so they will have their own rules and regulations, and each state will do it differently. That sounds like springtime in Complexity Land.

Q.What do you think will happen to the total cost of health care under reform?

A.Oh, it’s going to go through the roof! It’s widely accepted that this is not a cost-reform bill— it’s an access bill. It’s in fact a cost-expansion bill.

Q.Last year, Dr. Atul Gawande made a pretty cogentcase, writing inThe New Yorker, not just that the small pilot projects in the reform would control costs but that they are the only way to control costs in an industry as sprawling as health care.

A.I e-mail a lot with Atul and he’s a product ofthe Borg, at some big institution, and thinks in terms of papers and grants from Washington. I totally agree that demonstration projects are what changes a market, but outside of the Borg, we call those businesses. I suppose Washington trying to be an innovator also is fine, but at some point the demonstration project is going to have to be consumers using their judgment about which things they want.

Q.If you were still a small company, or if you were starting a business now, would health care reform help or hurt you as an employer?

A.Well, certainly the idea that somebody else is going to pay a lot of my health insurance cost, at the micro level, makes a lot of sense. It’d be great, yeah, thanks— anything else you want to pay for? If you actually ever have to start paying this thing, all of this accelerates the increase in the cost. Eventually, consumers will need to eat a big part of their health care cost, because health care will fundamentally consume the entire G.D.P. in the not-too-distant future.

Everybody agrees that this is good in the way that it creates engagement in society by those who are outcasts. So if you’re feeling like you don’t want to believe in America anymore because you don’t have health insurance, well, now you can believe a little more. It’s bad in terms of the macro economy. But I don’t know which one is more important in the grand scheme for today.

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