Yet people can, and often do, behave in very different ways.

A news search for the words “hero saves” will routinely turn up stories of bystanders braving oncoming trains, swift currents and raging fires to save strangers from harm. Acts of extreme kindness, responsibility and compassion are, like their opposites, nearly universal.

Why are some people prepared to risk their lives to help a stranger when others won’t even stop to dial an emergency number?

Scientists have been exploring questions like this for decades. In the 1960s and early ’70s, famous experiments by Stanley Milgram and Philip Zimbardo suggested that most of us would, under specific circumstances, voluntarily do great harm to innocent people. During the same period, John Darley and C. Daniel Batson showed that even some seminary students on their way to give a lecture about the parable of the Good Samaritan would, if told that they were running late, walk past a stranger lying moaning beside the path. More recent research has told us a lot about what happens in the brain when people make moral decisions. But are we getting any closer to understanding what drives our moral behavior?

Here’s what much of the discussion of all these experiments missed: Some people did the right thing. A recent experiment (about which we have some ethical reservations) at the University of Chicago seems to shed new light on why.

Researchers there took two rats who shared a cage and trapped one of them in a tube that could be opened only from the outside. The free rat usually tried to open the door, eventually succeeding. Even when the free rats could eat up all of a quantity of chocolate before freeing the trapped rat, they mostly preferred to free their cage-mate. The experimenters interpret their findings as demonstrating empathy in rats. But if that is the case, they have also demonstrated that individual rats vary, for only 23 of 30 rats freed their trapped companions.

The causes of the difference in their behavior must lie in the rats themselves. It seems plausible that humans, like rats, are spread along a continuum of readiness to help others. There has been considerable research on abnormal people, like psychopaths, but we need to know more about relatively stable differences (perhaps rooted in our genes) in the great majority of people as well.

Undoubtedly, situational factors can make a huge difference, and perhaps moral beliefs do as well, but if humans are just different in their predispositions to act morally, we also need to know more about these differences. Only then will we gain a proper understanding of our moral behavior, including why it varies so much from person to person and whether there is anything we can do about it.

If continuing brain research does in fact show biochemical differences between the brains of those who help others and the brains of those who do not, could this lead to a “morality pill” — a drug that makes us more likely to help? Given the many other studies linking biochemical conditions to mood and behavior, and the proliferation of drugs to modify them that have followed, the idea is not far-fetched. If so, would people choose to take it? Could criminals be given the option, as an alternative to prison, of a drug-releasing implant that would make them less likely to harm others? Might governments begin screening people to discover those most likely to commit crimes? Those who are at much greater risk of committing a crime might be offered the morality pill; if they refused, they might be required to wear a tracking device that would show where they had been at any given time, so that they would know that if they did commit a crime, they would be detected.

Fifty years ago, Anthony Burgess wrote “A Clockwork Orange,” a futuristic novel about a vicious gang leader who undergoes a procedure that makes him incapable of violence. Stanley Kubrick’s 1971 movie version sparked a discussion in which many argued that we could never be justified in depriving someone of his free will, no matter how gruesome the violence that would thereby be prevented. No doubt any proposal to develop a morality pill would encounter the same objection.

But if our brain’s chemistry does affect our moral behavior, the question of whether that balance is set in a natural way or by medical intervention will make no difference in how freely we act. If there are already biochemical differences between us that can be used to predict how ethically we will act, then either such differences are compatible with free will, or they are evidence that at least as far as some of our ethical actions are concerned, none of us have ever had free will anyway. In any case, whether or not we have free will, we may soon face new choices about the ways in which we are willing to influence behavior for the better.

Peter Singer, a professor of bioethics at Princeton University and a laureate professor at the University of Melbourne, is the author, most recently, of “The Life You Can Save.” Agata Sagan is a researcher.

A team led by David Kaufman of Johns Hopkins University did a random online survey of 1,048 people who had been customers of one of three genetic testing companies — Decode Genetics, Navigenics Inc and 23andMe Inc, which is backed by Google.

Overall, 77 percent of participants said they got tested to improve their health and 58 percent said they learned something new that would improve their health, Kaufman told the American Society of Human Genetics meeting in Washington. Such tests look for genetic predisposition to conditions like diabetes and heart disease.

Direct-to-consumer genetic tests have raised concern among U.S. health regulators who worry people will make health decisions based on inaccurate or inconsistent results.  In July, an undercover probe by the Government Accountability Office showed people who sent off their saliva to DTC testing companies might get a different answer to the same genetic question, depending on which company they used.

A U.S. Food and Drug Administration official said in July the agency would soon regulate the sale of the tests.

For more than three decades, the FDA has chosen not to regulate simple diagnostic tests developed in individual laboratories. It does regulate tests considered medical devices — tests used to diagnose or prevent disease.

People who try the unregulated direct-to-consumer tests tend to be better-educated and wealthier than the general public and are often motivated by curiosity about their own health and ancestry, the researchers found.

Testing companies say the tests are useful for modifying bad habits that could contribute to future health risks, especially if someone is predisposed to disease.

GENERAL SATISFACTION

According to the survey, more than a third of people said they were being more careful about their diet as a result of getting the tests, 15 percent had changed their medications or diet supplements and 14 percent were exercising more.

Some 88 percent of people said they were generally satisfied with the testing experience, and 90 percent said their curiosity was satisfied.

Most of those surveyed — 88 percent — said their results were easy to understand. Among the remaining 12 percent who did not, half said they were not satisfied with their test results.

To see how well people interpreted their results, the group asked people in the survey to review two test results provided by the companies and asked them questions about them. They found 4 to 7 percent of people got the results wrong.

Kaufman said long-term follow-up of direct-to-consumer testing was needed to evaluate how they affect people’s health.

FDA official Dr. Jeffrey Shuren said in July the agency had been watching DTC testing companies for some time, but grew concerned when Pathway Genomics announced a pact with Walgreen Co in April to distribute its tests through its 6,000 neighborhood pharmacies.

Pathway has since stopped selling its tests to consumers.

(Editing by Peter Cooney)

And when, last year, each learned that a lethal skin cancer called melanoma was 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 the cancer’s progress in certain patients. Both cousins had the type of tumor almost sure to respond to it. And major cancer centers, including the University 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’s tumors had 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 the chemotherapy drug 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,” said Dr. Paul B. Chapman, a medical oncologist at Memorial Sloan-Kettering Cancer Center who 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?’ ” said Dr. 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 the Food 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?”

He believed he should trade places on the trial with Mr. Ryan, who was pursuing his contractor’s license and had just bought a four-bedroom home in Bakersfield. “Brandon has everything going for him,” he told his Aunt Jan.

But Mr. Ryan told his mother he was glad that Mr. McLaughlin, who has a young son and daughter, was the one getting the promising drug. “Tommy has the kids,” he said. “They need him around.”

Path to a Second Trial

The debate over the controlled testing of PLX4032 began in June 2009, around the time Mr. McLaughlin awakened with what felt like an explosion under his right armpit.

The drug, manufactured by Roche, the Swiss pharmaceutical giant, was designed for melanoma patients whose tumors carry a particular mutation, and the company reported that month that nearly all 32 such patients in the drug’s first clinical trial, called Phase 1, had seen their tumors shrink.

The reprieve was all too brief: most saw their tumors begin to grow again within the year. Still, The New England Journal of Medicine called the drug “a major breakthrough” for people with advanced melanoma, whose median survival is eight months after diagnosis. A second, or Phase 2, trial, aiming to validate the results in more patients, was already in the works. And in meetings that summer, several oncologists urged Roche to seek accelerated approval from the F.D.A. The agency allows a manufacturer to sell a drug based on early promise so long as it proceeds with the traditional controlled trial comparing it with the standard treatment.

But with patients already begging doctors for the drug, it seemed unlikely that anyone would join a trial with only a 50-50 chance of getting PLX4032 once it was already on the market. Unless the trial was conducted before approval, it seemed, there would be no chance to get definitive data on its effectiveness.

Some melanoma specialists familiar with the drug would have traded the data for faster access to the drug. “I know all that I need to know based on the results we already have,” said Dr. Keith Flaherty of Massachusetts General Hospital, who led the early clinical testing. “My use of this drug is not going to be informed by testing it against a drug we all hate and would rather never give a dose of again in our lives.”

The standard chemotherapy used in melanoma, dacarbazine, slowed tumor growth in 15 percent of patients for an average of two months. By contrast, PLX4032 had halted tumor growth in 81 percent of patients for an average of eight.

It was conceivable that when the cancer started up again, it would progress much faster in patients who had taken the new drug, wiping out any extra time they might have gained. But even if so, many doctors believed that if the drug provided relief by shrinking tumors — like the one Mr. McLaughlin soon learned was pressing against a nerve in his arm — that would improve their patients’ lives.

The trial, moreover, would cost $100 million and delay the possibility of F.D.A. approval by at least two years. To some doctors, it seemed a waste of time and resources that would be better used for trials testing what everyone most cared about: how to prolong the remissions.

There was reason to believe that combining PLX4032 with other drugs — some from competitors — would make it more effective. But researchers had to rely on Roche for permission until the drug was available for sale, and the company had not been forthcoming.

Dr. Chapman of Sloan-Kettering came up with a new tack: an unconventional bid to speed the drug’s approval, rooted in the observation that patients weeks or days from death could get out of bed and off oxygen when given PLX4032, sometimes for months. The doctors working with the drug referred to this as the Lazarus effect; it was unheard of with dacarbazine.

A trial that cataloged PLX4032’s effect on the well-being of the sickest patients, Dr. Chapman argued, would probably yield fast, tangible results. For him, it represented a chance to give patients symptomatic relief, even if the drug turned out not to prolong life.

“Even without a survival benefit, maybe we could show that it helps people,” he urged. “If you could get Aunt Sadie to the wedding and off of oxygen, that would be great.”

But company officials feared that might lead to approval for only a narrow group of the sickest patients. The surest way to get the F.D.A’s endorsement for a broader market was a controlled trial. And with its competitors rushing to get similar drugs to market, the findings of such a trial might give Roche an advantage in marketing its version as the only one proven to prolong survival.

On Sept. 1 last year, the company submitted its plan to the F.D.A. for the traditional, randomized, controlled trial of PLX4032. It would involve 680 patients, half of them in a control group. Dr. Chapman would be the lead investigator for more than 100 sites in the United States, Europe and Australia. Because of the different ways the drugs were dispensed — one by mouth and one by infusions — doctors and patients, it was decided, would both know who got which drug.

The following week was when Mr. Ryan learned that his cousin might have a health problem. He called Mr. McLaughlin from a job site in Colorado, to tell him about his new Dodge Ram, a truck he knew Mr. McLaughlin had long coveted.

He invited Mr. McLaughlin to come stay with him: there was plenty of welding work, and he could help break in the truck. But Mr. McLaughlin, who had no health insurance, had finally visited a doctor about the pain under his arm. It was melanoma, and he would need surgery to remove some lymph nodes.

“Wow,” Mr. Ryan said, suddenly silent. “You have cancer?”

Two Men’s Struggles

Mr. McLaughlin’s surgery, it seemed, had come too late. In the weeks following, small tumors popped up across his body, including one on his collarbone and one on his triceps.

When Mr. Ryan discovered a swollen node under his own right armpit in October, his mother was not taking any chances. She begged him to go to the emergency room in Colorado. Even so, when the verdict was melanoma, both families were shocked.

Was it genes? Their mothers, after all, were sisters. But there was no history of cancer in the family.

Environment? The boys had fought, played and competed with each other since childhood: who could hold his breath the longest, do the highest cannonball dive, suck down a Slurpee fastest, win their grandfather’s approval? They had ranged across California on iron-working jobs, eating the same food, drinking the same large quantities of beer, promising, in a rare moment of seriousness, that each would bury the other with his hardhat when the moment came. Coincidence?

Compared with most cancers, melanoma strikes a disproportionate number of young people; it is the sixth most common cancer in the United States.

There was no way to know.

Last Thanksgiving, Mr. McLaughlin greeted Mr. Ryan with the usual bear hug. “Looks like we’re doing this together,” he said.

Not ones for excessively talking things over, they left it at that.

Yet both cousins, like the other family members, believed then that Mr. Ryan stood a far better chance of surviving the disease than his cousin. His cancer was rated Stage 3, with no evidence yet that it had spread to distant parts of his body. Mr. McLaughlin, at Stage 4, had a tumor ominously near his liver. And Mr. Ryan had health insurance, while Mr. McLaughlin had none.

It was the mutated gene that the U.C.L.A doctor found in Mr. McLaughlin’s cancer cells in December that turned his luck around. Called B-RAF, it goes awry in half of the 68,000 Americans who develop melanoma each year, for reasons not well understood, signaling cells to grow uncontrollably.

The mutation meant that he would be eligible for PLX4032’s new trial, so the cost of the drug and doctors’ visits would be paid by Roche. And it turned out he would get the pills even before the controlled study began, on a small test of the drug’s interaction with common drugs like caffeine and cough syrup. Judging by the response of patients to PLX4032 in the first trial, Mr. McLaughlin was almost certain to respond. But the medication, the doctors at U.C.L.A warned him, might cause a rash and fatigue and would probably make his skin extremely sensitive to the sun.

“They told me to get a job where I could be inside all the time,” Mr. McLaughlin told Mr. Ryan with a grin; perhaps no one else could better understand how ridiculous it seemed for someone who had spent his whole life outdoors.

Because the slots in the trial were reserved for patients with the most advanced cancer, Mr. Ryan was not eligible — yet. But because he had few symptoms, it hardly seemed to matter. After surgery to remove his cancerous lymph nodes and radiation, he was preparing to return to work.

“Dude, I had ALL of my lymph nodes out,” Mr. Ryan boasted to his cousin over a Mexican-style Christmas dinner at their grandmother’s home in Santa Maria, not passing up an opportunity at one-upmanship. “How many did you have out again, 11?”

Mr. McLaughlin, fingering the tumor that felt like a knot under his arm, might not have been in top form that evening. But he mustered a scoffing reply: “So you had all of them taken out and only four had tumors?”

The following week, he took his first pills.

But even as the tumor on Mr. McLaughlin’s collarbone began to melt away, a faint spot on Mr. Ryan’s lung began to grow.

A Life-or-Death Debate

The discontent among some oncologists over the design of the PLX4032 trial spilled over at a scientific meeting sponsored by the Melanoma Research Alliance in late February.

The ethical review boards at dozens of prestigious cancer research institutions had signed off on the trial, and the leading melanoma oncologists had embraced it: after all, it was the only way to get the most promising drug available for their patients.

But with the trial now under way, a few attending the Las Vegas meeting had already had to tell patients they had been assigned to the trial’s chemotherapy control group. And some had begun to question whether an ethical code that calls for doctors to be genuinely uncertain about which of a trial’s treatments will be more effective had been breached when it came to PLX4032 versus dacarbazine.

After Dr. Chapman presented the recent data from the drug’s promising first trial to a packed room, Dr. Neal Rosen, a friend and Sloan-Kettering colleague, stood up.

“Excuse me,” Dr. Rosen said with unusual formality. “But if it was your life on the line, Doctor, would you take dacarbazine?”

The room was silent.

“My goal,” Dr. Chapman shot back, “is to find out as quickly as possible in as few patients as possible whether this works. If we never know, then we’re never going to be able to build on anything.”

One of the melanoma field’s senior clinicians, Dr. Chapman had lived through trial after trial of drugs that failed to live up to early promise. Almost every oncologist knew, too, of a case nearly 20 years earlier when bone marrow transplants appeared so effective that breast cancer patients demanded their immediate approval, only to learn through a controlled trial that the transplants were less effective than chemotherapy and in some cases caused death.

“Making patients’ tumors go away is gratifying,” Dr. Chapman told critics. “But that’s not the business I’m in. I’m in the business of making people live longer. That’s what I want to do.”

Several of the most veteran melanoma doctors agreed with him. But others argued that oncologists had an ethical obligation to push both the F.D.A. and Roche to make the drug more immediately available.

Some of the strongest criticism came from laboratory researchers who study the biology of the disease and see the drug as fundamentally different from its predecessors. The previous red herrings, they argued, never had such a high response rate. Few other drugs had shrunk tumors in as high a percentage of patients with melanoma or any other solid tumor as PLX4032 had in its first human trial.

“Many of my colleagues who are outstanding clinical investigators have been able to convince themselves that this is a fair thing to do,” Dr. David E. Fisher, a leading melanoma biologist at Massachusetts General, said of the controlled trial. “My personal view is it’s nuts. I don’t know anyone who hasn’t shuddered at the concept that we can’t let patients on the control arm cross over because we need them to die earlier to prove this point.”

In the meantime, some doctors were searching for other trials that could help patients worsening in the chemotherapy group of the Roche trial, even at the risk of undermining its results. Several lobbied to get such patients slots on a new trial of a PLX4032 competitor, manufactured by GlaxoSmithKline.

“It’s much easier to tell patients, ‘We’ll try this for six weeks; if it’s working, great, if not, we’ll shift you right away to the other trial,” said Dr. Jeffrey A. Sosman of the Vanderbilt-Ingram Cancer Center in Nashville. “That’s how I’m going to be able to live with the randomization.”

The reason to prevent patients in the chemotherapy group from subsequently getting PLX4032 was to ensure a clean comparison. But who could prevent them from trying treatments that might well help them live longer? At least one melanoma patient left Sloan-Kettering’s care to join the Glaxo trial at New York University.

In April, Mr. McLaughlin donned a bandanna, a sun hat, a long-sleeved shirt and pants and went to a job building fences on a nearby ranch. The pills, he had vowed, would not prevent him from working outside.

Mr. Ryan’s health, by contrast, was declining. He returned from work only to sleep. Often, when his mother called, he was too tired to come to the phone. “Sleeping, Mom,” he would text her. Or “You have no idea what this feels like, Mom.” Or just, “I hurt.”

His doctor in Bakersfield moved up a scheduled scan.

At the same time, a debate grew heated over Roche’s decision to withhold PLX4032 from many patients not eligible for the trial because they had already been treated with chemotherapy.

The F.D.A. regularly approves such programs, known as “compassionate use,” for promising experimental drugs. But Roche feared a prospective trial candidate might undergo chemotherapy just to qualify for compassionate use and get PLX4032 with no strings attached.

In an emotional moment, Dr. Donald Lawrence of Massachusetts General Hospital e-mailed colleagues about Roche’s decision last spring, under the subject line “moral outrage.”

“Just had yet another conversation with a [patient] with a B-RAF mutation who will die in the next month or so because he can’t get PLX4032,” he wrote. “I feel we need to muster the support of our patients and lobby both Roche and the F.D.A. Compromising the Phase III trial is not justification for withholding an effective drug from dying patients.”

But Dr. Michael Atkins, director of the cancer clinical trials office at Beth Israel Deaconess Cancer Center in Boston, urged him to consider what he thought was the greater good: “Even though it is painful, I think completing a clean Phase III trial and determining if there truly is a survival benefit for PLX would have major value for the field and future patients.”

A Bitter Blow

On the morning of May 12, Mr. Ryan and his mother drove to U.C.L.A. The cancer had spread throughout his body. Yet that weekend, the family was filled with hope. Dr. Chmielowski had found the same gene mutation that Mr. McLaughlin had in one of Mr. Ryan’s tumors. He was finally eligible for the trial.

But the computer made its assignment the following Tuesday, making sure that he would not be getting his cousin’s “superpills.”

Mr. Ryan’s mother picked up the call while her son was undergoing radiation for the tumor on his spine. He was on oxygen.

“I’m sorry,” Dr. Chmielowski repeated as she cried into the phone.

There must be someone higher up to whom she could talk, she said.

There was not, he told her. It was completely random. No one could change it.

“Who else has this drug?” Mrs. Ryan demanded. “We will go wherever we have to go.”

There was nowhere to go, the doctor explained. Once Mr. Ryan had been randomly assigned to the control group at one place, the other hospitals testing the melanoma drug would not give it to him. U.C.L.A. had turned away such patients, too.

The doctor did not tell Mrs. Ryan about the Lazarus effect — that for someone as sick as Mr. Ryan, PLX4032 was probably the best chance to control his symptoms while doctors searched for something better.

The doctor could not know, of course, whether Mr. Ryan really would have fared better on the Roche drug, or whether Mr. McLaughlin’s disease would have been held in check just as well with the chemotherapy. Obeying the trial’s protocol meant withholding the drug from patients like Mr. Ryan, and that, Dr. Chmielowski would later explain, “is awful.”

He told Mrs. Ryan, if the chemotherapy could stabilize her son for just a month or so, there were two new trials opening that might help him.

“What gives them the right to play God?” Mrs. Ryan exploded at home later that night. “It doesn’t make sense to say, ‘We want you for a statistic’ instead of giving them a chance at life.”

Mr. Ryan started his infusion the next day. But a week later, he was hospitalized, unable to breathe on his own and in horrible pain.

“Bud brownies,” Mr. McLaughlin prescribed when he arrived to visit, having already signed himself up for medical marijuana use. “You get out of here, and I’ll make them for you.”

He rated the nurses, trying to make Mr. Ryan laugh.

“Maybe you should just say you want to split some of your pills with her and she’ll hop into bed with you,” he suggested after one left the room. A few minutes later, “No, that one’s a little cuter.”

Then he reminded his cousin of the time Mr. Ryan had thrown a bolt up to where he was sitting atop a wall for a welding job adjacent to a golf course. Mr. Ryan missed his mark by several feet and the bolt landed on the other side, shattering the windshield of another contractor’s truck.

“I’m like, ‘You just tagged that guy’s freakin’ truck,’ ” Mr. McLaughlin recounted for the other family members in the hospital room. On his side of the wall, Mr. Ryan had picked up a stray golf ball. “And then the guy walks out and Brandon goes, ‘Looks like those golfers hit your windshield.’ ”

In his hospital bed, Mr. Ryan was beginning to smile.

“And the guy gets in the truck,” Mr. McLaughlin finished, “and takes off for the golf course.”

Two weeks later, at his cousin’s funeral in mid-June, Mr. McLaughlin placed Mr. Ryan’s hardhat in his coffin and helped carry it to the grave.

Mr. McLaughlin has now been taking PLX4032 for nine months. He is awaiting his next CT scan.

The project, named Human Heredity and Health in Africa or “H3Africa,” will use genetic techniques developed in the West to explore the roots of human life among populations that carry the world’s oldest and most diverse sets of genes.

Founders of the plan say that 10 years after the first full human genome was mapped, what scientists can learn about genetic variation and disease in Africa will have global relevance.

“Africa is the cradle of humanity, so things that we learn in Africa will undoubtedly have broad implications for peoples in all other parts of the planet,” said Francis Collins, director of the U.S. National Institutes of Health (NIH).

But the idea is also to free Africa from what some describe as “scientific colonialism,” and to try to halt a brain drain of researchers who have tended to leave the continent to study the ups and downs of its health from afar.

Bongani Mayosi, head of the department of medicine at the University of Cape Town, said the project represents “a very, very important shift in the way science is done in Africa.”

“Up until now, we have been operating almost in a colonial mode of doing science, where people from outside Africa have been coming to collect samples, and then processing them and publishing their papers outside Africa,” Mayosi said at a briefing in London to explain the project.

“What is different about this initiative is that it seeks to do science in Africa, by Africans and for Africans.”

HUGE NEED, BUT LITTLE CAPACITY

With $25 million from the NIH and $12 million from the London-based global charity the Wellcome Trust, H3Africa plans to build expertise in countries where it is much needed but sorely lacking, so that African scientists can in future conduct large, robust scientific studies on their own people.

Researchers will help set up ‘biobanks’ to collect DNA and medical information from hundreds of thousands of African people so that scientists can study links between genes and disease.

They also hope to set up or build on local research centers and use genome-wide scanning and sequencing technologies to find genetic change that may contribute to specific illnesses.

Some studies will focus on the role genes play in Africa’s biggest killer diseases — malaria, tuberculosis and HIV/AIDS — while others will look at conditions like high blood pressure, heart disease and stroke, all of which are becoming widespread in African populations.

Despite the huge burden of infectious disease that it carries, Africa lags the rest of the world in health research: a report from Thomson Reuters in April found its contribution to the global body of scientific research is very small and does little to benefit its own populations.

It said Africa suffers from a “hemorrhage of talent,” with many of its best brains leaving to study abroad.

LARGELY IGNORED, UNTIL NOW

Speaking in a week when scientists are marking the 10th anniversary of the publication of the first draft of the human genome, Charles Rotimi, president of the African Society of Human Genetics, said his continent had been largely ignored by the genetic revolution.

In the U.S., Europe and Asia, ever faster gene sequencing tools have enabled scientists to begin to untangle the genetic roots of many major diseases and explore their links and interactions with environment and lifestyle factors like diet.

Genome-wide association studies, which scan gene maps, are an important tool in this work. But of the hundreds of such studies conducted in the past decade, only one, on malaria, was based on African populations — a state of affairs that Rotimi described as “really tragic.”

“It is clear that so far we have not equally applied the tools of genomics,” he said.

“Africa is the trunk and root of human evolutionary history, so what we get from there is going to be equally important to other parts of the world.”

(Editing by Mark Trevelyan)

Members of the tiny, isolated tribe had given DNA samples to university researchers starting in 1990, in the hope that they might provide genetic clues to the tribe’s devastating rate of diabetes. But they learned that their blood samples had been used to study many other things, including mental illness and theories of the tribe’s geographical origins that contradict their traditional stories.

The geneticist responsible for the research has said that she had obtained permission for wider-ranging genetic studies.

Acknowledging a desire to “remedy the wrong that was done,” the university’s Board of Regents on Tuesday agreed to pay $700,000 to 41 of the tribe’s members, return the blood samples and provide other forms of assistance to the impoverished Havasupai — a settlement that legal experts said was significant because it implied that the rights of research subjects can be violated when they are not fully informed about how their DNA might be used.

The case raised the question of whether scientists had taken advantage of a vulnerable population, and it created an image problem for a university eager to cast itself as a center for American Indian studies.

But genetics experts and civil rights advocates say it may also fuel a growing debate over researchers’ responsibility to communicate the range of personal information that can be gleaned from DNA at a time when it is being collected on an ever-greater scale for research and routine medical care.

“I’m not against scientific research,” said Carletta Tilousi, 39, a member of the Havasupai tribal council. “I just want it to be done right. They used our blood for all these studies, people got degrees and grants, and they never asked our permission.”

Researchers and institutions that receive federal funds are required to receive “informed consent” from subjects, ensuring that they understand the risks and benefits before they participate. But such protections were designed primarily for research that carried physical risks, like experimental drug trials or surgery. When it comes to mining DNA, the rules — and the risks — are murkier.

Is it necessary, for instance, to ask someone who has donated DNA for research on heart disease if that DNA can be used for Alzheimer’s or addiction research?

Many scientists say no, arguing that the potential benefit from unencumbered biomedical research trumps the value of individual control.

“Everyone wants to be open and transparent,” said Dr. David Karp, an associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, who has studied informed consent for DNA research. “The question is, how far do you have to go? Do you have to create some massive database of people’s wishes for their DNA specimens?”

The Havasupai settlement appears to be the first payment to individuals who said their DNA was misused, several legal experts said, and came after the university spent $1.7 million fighting lawsuits by tribe members.

Even as the Havasupai prepared to reclaim the 151 remaining blood samples from a university freezer this week, Therese Markow, the geneticist, defended her actions as ethical. Those judging her otherwise, she suggested, failed to understand the fundamental nature of genetic research, where progress often occurs from studies that do not appear to bear directly on a particular disease.

“I was doing good science,” Dr. Markow, now a professor at the University of California, San Diego, said in a telephone interview.

Edmond Tilousi, 56, a cousin of Carletta Tilousi and the tribe’s vice chairman, can climb the eight miles from his village on the floor of the western Grand Canyon to the rim in three hours, when he is in a rush. Horse or helicopter are the other ways out, and Mr. Tilousi is increasingly rare among the tribe’s members in his ability to make the hike. Beginning in the 1960s, an extraordinarily high incidence of Type 2 diabetes led to amputations, even among the younger members, and forced many to leave the canyon for dialysis.

In late 1989, Mr. Tilousi’s uncle Rex Tilousi approached John Martin, an Arizona State University anthropologist who had gained the tribe’s trust, to ask if he knew a doctor who could help. “I asked him, ‘How can we prevent this from spreading?’ ” the elder Mr. Tilousi recalled.

Professor Martin approached Dr. Markow. A link had recently been reported between a genetic variant and the high rate of diabetes among Pima Indians. If a similar link was found among the Havasupai, it might point to an important risk factor.

The two professors received money from the university to study diabetes in the tribe. Dr. Markow was interested in schizophrenia research as well, and in the summer of 1990, with a grant from the National Alliance for Research on Schizophrenia and Depression, she and her graduate students began collecting blood samples in Supai. Women here remember being happy to see her in those days, an athletic figure who talked to them about how to be more healthy. Working out of the health clinic in the center of the village, Dr. Markow recruited tribe members to ask others to give blood.

“I went and told people, if they have their blood taken, it would help them,” said Floranda Uqualla, 46, whose parents and grandparents suffered from diabetes. “And we might get a cure so that our people won’t have to leave our canyon.” Roughly 100 tribe members who gave blood from 1990 to 1994 signed a broad consent that said the research was to “study the causes of behavioral/medical disorders.”

The consent form was purposely simple, Dr. Markow said, given that English was a second language for many Havasupai, and few of the tribe’s 650 members had graduated from high school. They were always given the opportunity to ask questions, she said, and students were also instructed to explain the project and get written and verbal consent from donors.

Dr. Markow examined several genes that were thought to have medical relevance, including for schizophrenia, metabolic disorders and alcoholism, she said, but found little to pursue. The Havasupai did not, it turned out, share the gene variant linked to diabetes in the Pima.

But a few years later, a graduate student using new technology came up with a way to discern variations in the Havasupai DNA, which was stored in a university freezer, and he wrote a dissertation based on his research.

Carletta Tilousi, one of the few Havasupai to attend college, stopped by Professor Martin’s office one day in 2003, and he invited her to the student’s doctoral presentation.

Ms. Tilousi understood little of the technical aspect, but what she heard bore no resemblance to the diabetes research she had pictured when she had given her own blood sample years earlier.

“Did you have permission,” she asked during the question period, “to use Havasupai blood for your research?”

The presentation was halted. Dr. Markow and the other members of the doctoral committee asked the student to redact that chapter from his dissertation.

But months later, tribe members learned more about the research when a university investigation discovered two dozen published articles based on the blood samples that Dr. Markow had collected. One reported a high degree of inbreeding, a measure that can correspond with a higher susceptibility to disease.

Ms. Tilousi found that offensive. “We say if you do that, a close relative of yours will die,” she said.

Another article, suggesting that the tribe’s ancestors had crossed the frozen Bering Sea to arrive in North America, flew in the face of the tribe’s traditional stories that it had originated in the canyon and was assigned to be its guardian.

Listening to the investigators, Ms. Tilousi felt a surge of anger, she recalled. But in Supai, the initial reaction was more of hurt. Though some Havasupai knew already that their ancestors most likely came from Asia, “when people tell us, ‘No, this is not where you are from,’ and your own blood says so — it is confusing to us,” Rex Tilousi said. “It hurts the elders who have been telling these stories to our grandchildren.”

Others questioned whether they could have unwittingly contributed to research that could threaten the tribe’s rights to its land. “Our coming from the canyon, that is the basis of our sovereign rights,” said Edmond Tilousi, the tribe’s vice chairman.

Many members are still suffering from diabetes and say they were never told if researchers had learned anything that could help them. The classes on nutrition that Dr. Markow had sponsored with grant money have since petered out.

Ms. Uqualla, who had recruited blood donors, said she felt shamed by the news that it had been used for research that could potentially damage the tribe. “I let my people down,” she said.

The money from the settlement will be divided among the 41 tribe members. Ms. Uqualla, for one, hopes to buy a horse trailer.

But Stephen F. Hanlon, a lawyer who has represented the tribe members without charge, said the resources the university agreed to provide, including scholarships and assistance in obtaining federal funds for projects like a new health clinic, had the potential to transform the tribal village at the bottom of one of the world’s most famous natural wonders.

On Tuesday, Ms. Tilousi cried as a university official unlocked the freezer in the nondescript storage room in the Tempe campus where the blood samples had long been stored. Wearing protective glasses, gloves and a lab coat, she and a delegation of tribal members sang in Havasupai as they saw the blood that had been taken from them and from their relatives, now dead.

On the box inside the freezer was scrawled the name, “Markow.”

The key: A gene that produces a substance called interleukin-10. Among IL-10’s many jobs is tamping down inflammation from the very molecules most prone to damage lungs. But when lungs are donated, they’re quickly put on ice to stop tissue deterioration, and that keeps whatever IL-10 remains from working. So Dr. Shaf Keshavjee, University Health Network’s lung transplant chief, devised a two-part fix:

First, create a body-temperature chamber that will keep the lungs alive outside the body. His team created a protective dome to house the lungs, where a solution of oxygen and nutrients is pumped into them, mimicking the body but minus the blood. Second, insert a gene into those lungs that will quickly produce high levels of IL-10 and reverse the inflammation. His team reports success in Wednesday’s journal Science Translational Medicine. They stuck the IL-10 gene into an adenovirus, from the family of cold viruses, so it would be taken up by lung cells, and snaked the virus inside the airways of the dome-preserved lung. Using lungs first from a handful of pigs and then from humans — 10 donor lungs that had been rejected for transplant — the team found that lungs receiving the gene therapy significantly improved their ability to take in fresh oxygen and get rid of carbon dioxide, they reported. When lungs are injured, fluid breaks barriers to leak where only air is supposed to be, and that damage was fixed. “The beauty of what we’re doing here, is we’re transducing the cells in the lung to become little IL-10 factories,” Keshavjee said. “It’s personalized medicine for the organ, if you will.” The human lungs weren’t transplanted into sick patients. That’s a much bigger step that Keshavjee hopes to try in an experiment sometime in the next year. But he transplanted a few pigs with repaired pig lungs, and found they were functioning significantly better four hours after transplant than lungs that didn’t get gene therapy. Moreover, if the IL-10 lasts long enough, it potentially could help protect against post-transplant inflammation, too, a question for future experiments. Specialists said those tests should track how long repaired lungs last in animals before they’re tried in people. Some gene therapy experiments have documented side effects from adenovirus, cautioned Indiana University lung specialist Dr. David Wilkes in an editorial published with the research. Keshavjee said the adenovirus disappears relatively soon after delivering the gene, lessening risk of body-wide side effects. “If effective, these approaches will truly be a breath of fresh air for prospective lung transplant recipients,” Wilkes concluded. Copyright © 2009 The Associated Press. All rights reserved.

In an industry first, Eli Lilly and Co. said it will begin disclosing how much money it paid to individual doctors nationally for advice, speeches and other services.  The drug company’s move comes as members of Congress push a disclosure bill in an effort to prevent such payments from improperly influencing medical decisions. Beginning next year, Eli Lilly will disclose payments of more than $500 to doctors for their roles as advisers and for speaking at educational seminars. In later years, the company will expand the types of payments disclosed to include such things as travel, entertainment and gifts.  Read full RGJ article here.

The California Department of Public Health sent “cease and desist” letters to 13 genetic testing companies two weeks ago, telling them they could not solicit business from state residents. The companies include the early leaders in the field — 23andMe, Navigenics and deCode Genetics — which are trying to carve out a new business of offering personal genetic information for use in health and lifestyle planning.

The California action follows efforts by New York State, which has sent letters to 31 genetic testing companies since November, saying they need licenses to solicit DNA specimens from the state’s residents.

Pressure is also mounting for the federal government to take more action. A report in April by a federal advisory committee said there were significant gaps in the oversight of genetic tests that could lead to patient harm. The Department of Health and Human Services will hold a two-day public meeting July 7 and 8 to discuss regulation of personal genetic information services.

The Federal Trade Commission, meanwhile, has started investigations into possibly deceptive advertising or marketing of genetic tests, according to an agency official who spoke at a June 12 meeting convened by Senator Gordon Smith. The senator, an Oregon Republican, has been prodding federal agencies to take a stronger stance in overseeing genetic tests sold to consumers.

Yet the move to regulate the tests is raising many issues. What are the standards for proving a genetic test is valid? Must a doctor always be involved in ordering such tests to protect patients, or is that an attempt by doctors to protect their turf?

Some of the companies say people have a right to know the information in their genes and to guide their own health care.

“We think your genetic information is a fundamental part of you,” said Anne Wojcicki, a co-founder of 23andMe. The company, based in Mountain View, Calif., has attracted attention not only because of its $1,000 genome testing service but because it is partly financed by Google and because Ms. Wojcicki is married to the Google co-founder Sergey Brin.

Navigenics and 23andMe say they are not offering medical testing, but rather personal genetic information services. Using a saliva sample, they scan a person’s genome at multiple points looking for variations that might indicate a person is at a higher than normal risk for certain diseases.

“This doesn’t say you have a disease,” said Mari Baker, the chief executive of Navigenics, which is based in Redwood Shores, Calif., and whose service costs $2,500. “It says you carry a genetic predisposition for the disease and should talk with a health care professional.”

But not everyone agrees with that rationale.

“We think if you’re telling people you have increased risk of adverse health effects, that’s medical advice,” said Ann Willey, director of the office of laboratory policy and planning at the New York State Department of Health.

Genetic tests that are developed by clinical laboratories generally do not require approval by the Food and Drug Administration before they can be marketed.

The laboratories themselves are regulated by the Centers for Medicare and Medicaid Services. Such regulation is meant to ensure that laboratories are proficient and that the tests are “analytically valid.” That means that if a test purports to detect a particular genetic variation, it does so reliably.

But critics say such regulation does not assure that tests are “clinically valid” — that having a particular genetic variation actually means a person has a disease or is at risk for one. Critics also say many tests now being sold to consumers are not backed by adequate scientific studies.

The California letters, sent on June 9 and 10, said the companies needed to have state licenses as clinical laboratories. In addition, they said, genetic tests could be ordered only by a doctor, not by consumers.

“We started this week by no longer tolerating direct-to-consumer genetic testing in California,” Karen L. Nickel, chief of laboratory field services for the state health department, said during a June 13 meeting of a state advisory committee on clinical laboratories.

Lea Brooks, a spokeswoman for the health department, said the letters were sent in response to consumer complaints about the cost and accuracy of the tests.

Most of the attention so far has focused on Navigenics and 23andMe because of their high profiles and the fact that they acknowledged getting the state’s letters. The identities of most of the other recipients were unknown until Tuesday, when the state health department posted all 13 letters on its Web site.

The other recipients include Knome, which is offering to do a complete sequence of a person’s genome for $350,000.

Also on the list were a few companies that give diet advice based on a person’s genes (and in some cases also sell dietary supplements). There were also some companies that offer genetic tests for single conditions, like the risk of baldness or Alzheimer’s disease.

The companies had until this Monday or Tuesday to respond to the agency, which will now review the responses.

At least one company that received a letter, Sciona, has stopped offering its gene testing and related diet advice to residents of California and New York. DeCode’s Web site indicates that certain calculations of disease risk will not be available to residents of New York, California and several other states.

But Navigenics and 23andMe say they believe they comply with the regulations and are continuing to accept samples from Californians. Navigenics has stopped accepting orders from New York while its laboratory seeks a state license. But 23andMe said it continues to accept orders from New York.

Both companies say they do not need a license from California because the genome scans are actually performed by outside laboratories that do have state licenses.

Navigenics said its tests are ordered by a physician because a doctor on contract to the company reviews customer orders before the specimens are passed to the testing laboratory.

But Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University, said that “some doc on the payroll at Genes R Us” is not the same as a personal physician.

Dr. Hudson said it was “not surprising that the states are stepping in, in an effort to protect consumers, because there has been a total absence of federal leadership.” She said that if the federal government assured tests were valid, “paternalistic” state laws could be relaxed “to account for smart, savvy consumers” intent on playing a greater role in their own health care.