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.”

[Newsweek] The unsettling story of Henrietta Lacks begins with an everyday occurrence: a trip to the doctor’s office. The 30-year-old African-American’s 1951 diagnosis of cervical cancer would change her life, and the damaged cells taken from her body without permission would alter the course of medical history. At a time when health-care reform is a key concern for the White House and millions of Americans, Lacks’s story is a potent reminder of the injustices that were perpetrated by the health-care industry on the poor and uneducated not long ago. 

Raised by her grandfather on a tobacco farm in Virginia, Henrietta Lacks was the granddaughter of slaves. She gave birth to her first child at 14 and later married the father of the baby, who happened to be her first cousin—not uncommon at the time. Shortly after Henrietta turned 30, she felt a knot in her lower stomach that she knew meant something was wrong. But with a husband and a house full of kids to take care of, Lacks could ill afford to worry for long; her family also had little money for a doctor’s visit, and at the time, many hospitals offered African-American patients substandard treatment.

Months later, after the birth of her fifth child, the knot was still there, so Lacks finally asked her husband to drive her to Johns Hopkins hospital, the only medical facility nearby that saw “colored people” for free. There, the doctors diagnosed Lacks with stage I epidermoid carcinoma of the cervix, which would require her to have radiation treatments a few times a month. During her first two-night stay in the hospital, doctors sliced several pieces of tissue from her cancerous tumor and placed them in a dish in the hopes of growing and studying them. Neither Lacks nor her family gave permission for her cells to be taken.

George Gey, then the head of tissue-culture research at Johns Hopkins, had been trying to grow malignant cells outside the body for nearly three decades, hoping to determine what caused cancer and ultimately how to cure it. Most cells died quickly in the lab, and the few that did survive failed to grow. But Gey was determined to grow the first immortal human cells—a continuously dividing line of cells that all descended from one original sample, cells that would replenish themselves and never die. Lacks’s damaged cells turned out to be the answer to his prayers. Her cancer cells grew unlike any the doctor had seen before, doubling in number every 24 hours. Excited by the findings, Gey began to alert his peers that he was sure he’d found the first immortal cells. And then he began sending Lacks’s cell culture, named “HeLa” to avoid using Lacks’s name, to any scientist who was interested in using it for cancer research. He sent the cells to Texas, India, New York, Amsterdam—anywhere researchers might find them useful.

But neither Gey’s excitement nor research helped Henrietta Lacks. Six months after being diagnosed with cancer, she was dead. She was taken back to her hometown of Clover, Va., and buried in a plain wooden box in an unmarked grave. It would be years before her family would realize that her living cells, which survive to this day, had birthed a multimillion-dollar industry selling human biological materials and had contributed to the study of cancer, had helped in developing the polio vaccine, and had allowed scientists to determine the effects of the atom bomb. They also led to important advances in in vitro fertilization, cloning, and gene mapping. HeLa has been bought and sold by millions of researchers in the decades since, likely earning hundreds of millions of dollars for the medical industry. Johns Hopkins maintains it never benefited financially from the sale of the cells.

Neither did the Lacks family. Most of Henrietta’s children died with only limited knowledge of what had actually been done with their mother’s cells, and today few of her grandchildren or other relatives can even afford to have insurance of their own, according to a new book by Rebecca Skloot, The Immortal Life of Henrietta Lacks.

Some 60 years after doctors committed what today would be an unconscionable violation of medical ethics, there’s still only limited information on how often the practice of taking samples without consent was done to patients of poor backgrounds and limited education. But Henrietta Lacks certainly wasn’t the only African-American mistreated by the American medical establishment. Books such as Harriet Washington’s Medical Apartheid  have documented many cases of blatant misuse of medical practices on unknowing and unsuspecting black patients in the name of furthering science and discovering cures.

It might seem as though this kind of disturbing and unethical practice would be limited to another, less-enlightened time, such as the ’30s and ’40s, which is when the granddaddy of all medical injustices, the infamous Tuskegee syphilis study, began. But some evidence uncovered by Washington’s book suggests that black orphan children were used as test subjects as recently as the ’80s in New York: tests to determine the effectiveness of some AIDS treatments were given to the children without adult consent.

In a just world, Henrietta Lacks’s descendants would have health care given to them free for the rest of their lives, like the victims of the Tuskegee study. But instead her case stands as yet another example of the medical establishment’s mistreatment of poor and minority Americans, the aftereffects of which linger to this day.

Find this article at http://www.newsweek.com/id/233671

The requirements will go beyond existing disclosure rules at many medical journals to include items such as financial relationships involving spouses, partners or minor children. Also required will be disclosure of nonfinancial conflicts, such as religious and political affiliations. Such disclosures are used in medical journals to alert readers to potential biases in research.

At least a dozen publications have agreed to use a new, standardized disclosure form, which will be phased in over the next several months.

By standardizing what researchers report to different medical journals, the editors are attempting to address complaints about the existing system for disclosing conflicts of interest. Researchers say medical journals’ differing policies are confusing and lead to inadvertent omissions. Advocates for better reporting of financial conflicts say a researcher’s potential conflict may be listed in one publication but not another.

The new form from the International Committee of Medical Journal Editors is being published this week by all of the group’s members, which include the New England Journal of Medicine, the Lancet and the Journal of the American Medical Association. The group is urging medical journals that aren’t members to adopt the form.

The form lists a broad array of financial relationships that must be reported. In addition to consulting work and honoraria, researchers must disclose when they provide expert testimony, receive grants or accept payments for manuscript preparation, patents or royalties. Researchers must report relationships going back three years. Some journals have only required reporting of current financial ties.

One of the editors involved in crafting the form, Christine Laine of the Annals of Internal Medicine, said it may be changed depending on feedback from researchers and others.

One area that could be controversial is nonfinancial disclosures. Dr. Laine said the editors “struggled a lot” with how best to get researchers to convey possible conflicts beyond payments from medical companies and others. As an example of a potential conflict that should be disclosed, she cited a researcher who also serves as the unpaid chairman of an advocacy group for a disease.

Former New England Journal of Medicine editor Jerome Kassirer, who has called for better reporting of financial conflicts, said the requirement to disclose nonfinancial conflicts of interest was “a little excessive.”

Write to David Armstrong at david.armstrong@wsj.com

 Sotomayor was diagnosed with Type 1 diabetes when she was 8 years old. People with the condition have shorter life spans — seven to 10 years shorter, according to the Juvenile Diabetes Research Foundation. Sotomayor will be 55 next month.

Before the appointment, some in the blogosphere raised her health as an issue, noting that Supreme Court justices may serve for life — often several decades. But diabetes experts say that not all diabetics live shorter lives.

“To automatically jump to the conclusion that it’s going to shorten her life span, of course, is not at all fair,” says University of Washington endocrinologist Paul Robertson.

He says the shorter life span happens when some people with diabetes don’t take care of themselves. With proper treatment, Sotomayor and others can live long lives.

“I think the pertinent question is how is she dealing with it, how’s she taking care of it? Is she doing a good job?” says Robertson. “Those kinds of questions make sense because you’d ask the same questions of somebody with a chronic disease like heart disease or cancer or leukemia.”

Robertson, the president for medicine and science for the American Diabetes Association, says treatment now is advanced and easy. “You can handle diabetes. It’s just basically, you need to do the right things. You need to check your blood glucose, make rational decisions about how much insulin to give yourself and do it. So it’s not rocket science these days.”

The White House noted that Sotomayor has lived with her diabetes for decades and that she has successfully kept it under control with insulin injections.

Political scientist David Atkinson says the fact that Sotomayor’s been open about her diabetes is something new when it comes to the Supreme Court.

Atkinson, a professor at the University of Missouri, Kansas City, who has written about the health of Supreme Court justices, says even recent and current members of the high court have kept their medical issues hidden.

“Chief Justice Rehnquist was very reluctant to disclose his health difficulties,” he says of Rehnquist’s battle with thyroid cancer. “And Ruth Bader Ginsburg did not initially disclose her cancer difficulty. But subject to a certain amount of media pressure, she began to do so.” (Ginsburg was reluctant to disclose her colon cancer in 1999. But earlier this year, she was quick to go public when she was diagnosed with a pancreatic tumor.)

Atkinson says Sotomayor’s health problems are mild compared to those of other justices. “The consensus seems to be this is not a disqualifying kind of ailment,” he says. “You know, after all, John Paul Stevens was put on the court by President Ford after he had open heart surgery. And Justice Stevens has served for a very long time on the Supreme Court.”

Chai Feldblum, a professor at the Georgetown University Law Center who has a specialty in disability civil rights law, says Sotomayor’s example could reduce the stigma that exists around diabetes.

“It matters that a nominee for the Supreme Court is someone who acknowledges she has diabetes and that forms an aspect of her life,” says Feldblum. Disability civil rights groups noted that, at a time when other judges had limited the scope of the Americans with Disabilities Act, Sotomayor ruled in favor of disabled plaintiffs, including a woman with learning disabilities who’d gotten extra time on tests during law school but then was denied the same accommodation when she tried to take the bar exam.

Still, people with diabetes say they often have reason to hide their condition: Sometimes they face discrimination.

Just last week, a federal jury found the FBI had discriminated when it refused to hire police officer Jeff Kapche to be a special agent because he managed his Type 1 diabetes with insulin injections. One diabetes blog said the Sotomayor nomination showed that people with diabetes now can break the glass ceiling for chronic illnesses.

-Joseph Shapiro

Herald Sun readers and people across Australia moved by the plight of Dr Bernhard Moeller and his son, Lukas, have protested. Premier John Brumby yesterday joined the fight, slamming the decision to reject Dr Moeller, the only specialist physician in Horsham, in the state’s west, because of a ruling that the potential long-term costs of caring for his 13-year-old son are too great.

Immigration Minister Chris Evans was under growing pressure last night to find a way to over-rule a decision to reject the doctor’s application for permanent residency.

http://www.heraldsun.news.com.au/

Beginning in January 2009, state employees will be required to receive medical screenings for several conditions, including body mass index (BMI). Those who are considered obese — along with exhibiting other negative health factors — will have a year to get in shape. The penalty for failure? A $25 increase in their monthly insurance costs.

Although critics view the penalty as a “fat tax,” Alabama officials believe the new policies will result in fitter, healthier, and happier employees — as well as help reduce the state’s mounting health care costs.

“Our goal was to make our members aware of those risk factors,” Deborah Unger, RN, clinical director for the Alabama State Employees Insurance Board in Montgomery, tells WebMD. “As long as you are aware and are doing something to correct it, there won’t be a fee. We either do something to control claims costs or you pay the premium anyway.”

Alabama now ranks as the second most obese state in the U.S., according to the CDC — perhaps a clear sign that change is needed. In addition to BMI, the state will screen three additional criteria: cholesterol, blood pressure, and glucose levels. These four risk factors have consistently resulted in costly treatments for the state.

Opponents of the Obesity Penalty

While the plan might seem practical, some experts question whether paying a fee for being obese is the best motivator for overweight people.

“We certainly wouldn’t support these kinds of punitive measures,” says Jeffrey Levi, PhD, executive director of Trust for America’s Health and associate professor of health policy at George Washington University School of Public Health. “The successful measures by health plans focus on incentives rather than punishment.”

The Alabama requirements, Levi tells WebMD, could be interpreted as a genetic penalty for those who are predisposed to having extra weight or high cholesterol. Some people also require a variety of treatments or medications before finding one that is effective. Making those who fail pay from their pockets also places more economic pressure on them, he says, which could lead them to turn to cheaper, calorie-dense food.

“We need to recognize the complexity of these things,” Levi says. “Just addressing this through the health care system is insufficient. What are we doing about the workplace environment? What’s served in state cafeterias and hospitals? We need to do the voluntary things first for people to be able to make healthy choices before forcing punitive measures.”

Alabama employees at risk will receive some help in their quest. The state is arranging programs with Weight Watchers and offering employees YMCA discounts. Information will also be available at behealthy.com, a Blue Cross-Blue Shield web site that provides online wellness tools and news.

But the prime motivator for this policy is hefty health care costs. And the attitudes of employers and employees may reflect an ambition to help remove obesity from the equation.

A recent survey conducted by the National Opinion Research Center (NORC) at the University of Chicago, partnered on the research with the George Washington University School of Public Health and Health Services, showed that:

• 80% of employees, regardless of weight, believe healthy lifestyles/weight management programs belong in the workplace.
• 67% of employers are concerned about obesity’s effect on medical claims expenses.
• 93% of employers see obesity as a preventable condition and due to poor lifestyle choices.
• Fewer than half of employers believe their company has given enough attention to the problem of obesity.

Christy Ferguson, director of the STOP Obesity Alliance in Washington, D.C., which commissioned the survey, tells WebMD that while employers are eager to promote weight loss, only about a quarter of those surveyed believe financial penalties should be placed on those who have difficulty succeeding.

“While employers and employees favor positive financial incentives, they oppose negative financial penalties,” she says. “There’s a strong support for the carrot, so to speak, and not-so-strong support for the stick.”

Key in all of these programs and findings is that shedding excess pounds is intrinsic to good health. But does thin and trim always equal fit and healthy?

A report released this month by The Archives of Internal Medicine, which weighed cardiometabolic risk factors vs. weight, revealed that among the 5,440 participants — U.S. adults 20 years old and older — 23.5% of “normal weight” adults were metabolically abnormal. Conversely, 51.3% of adults deemed overweight and 31.7% classified as obese were declared “metabolically healthy.”

Lifestyle and activity levels certainly vary between individuals, but the link between weight and health doesn’t appear to be absolute. And unlike many conditions which remain discrete, obesity is on full display.

“I don’t think we can arbitrarily pick out one specific set of people with health risks,” San Francisco internist Ann Haiden, MD, tells WebMD. “There is evidence that fit people with a little excess weight can actually be healthier than unhealthy normal-weight people. What we don’t need is for a policy like this to turn into yet another reason to exclude as many people as possible from the insurance pool.”

Even with a $25 monthly bill, Alabama state workers boast a plum health care plan. Single state employees pay no insurance fees, Unger says, while family plans — which can include a spouse and several children — only cost $180 per month. Spouses and children of state workers will not be subject to the wellness screenings.

Legally, these new protocols could face few serious threats.

Myra Creighton, an Atlanta labor and employment attorney who specializes in health-related issues, says many people are unsympathetic to obese individuals, which could make civil liberties organizations reluctant to pursue opposition. Michigan, she says, is the only state where weight is categorized as a protected class for workers.

Still, she does question certain ethical aspects of these actions.

“Do I have any privacy interests in my body weight?” Creighton says. “I’m just glad my firm doesn’t require me to hop on a scale.”

While the converted are often the most zealous agents for change, one Alabama resident who triumphed against the scale finds the state requirements somewhat troubling.

Enterprise, Ala.-resident Roger Shultz, this year’s runner-up on the NBC TV show The Biggest Loser, nearly cut his formerly obese physique in half while appearing on the show. Shultz, who lost 164 pounds, has kept his 6-foot-3-inch frame at a lean 222 pounds since the show ended. He’s now a spokesman for Scale Back Alabama, a state-sponsored campaign that promotes weight loss and exercise.

Keeping trim in Alabama is sometimes challenging: “We deep-fry everything,” he tells WebMD. But instituting fines for failing doesn’t seem like the right step to him.

“I worked for a state institution and I’d hate to see something monetarily taken away from me,” says, Shultz, who was employed at two Alabama colleges. “We have to be healthy, but I don’t think you should penalize people for being heavy.”
http://www.webmd.com/diet/news/20080825/alabama-obesity-penalty-stirs-debate?page=3

Writing in the British Medical Journal, John Guillebaud (emeritus professor of of family planning at UCL) and Pip Hayes (a GP) raise the spectre of global population explosion, and suggest that the children of the developed world are a particularly severe carbon burden.

The Optimum Population Trust calculates that “each new UK birth will be responsible for 160 times more greenhouse gas emissions . . . than a new birth in Ethiopia.” Should UK doctors break a deafening silence here? “Population” and “family planning” seem taboo words … isn’t contraception the medical profession’s prime contribution for all countries?Unplanned pregnancy, especially in teenagers, is a problem for the planet, as well as the individual concerned. But what about planned pregnancies? Should we now explain to UK couples who plan a family that stopping at two children, or at least having one less child than first intended, is the simplest and biggest contribution anyone can make to leaving a habitable planet for our grandchildren? We must not put pressure on people, but by providing information on the population and the environment, and appropriate contraception for everyone (and by their own example), doctors should help to bring family size into the arena of environmental ethics, analogous to avoiding patio heaters and high carbon cars.

In quoting the Optimum Population Trust – a population-reduction pressure group – the two docs are quoting themselves: both are involved in the running of the Trust. The Trust’s position on UK population is clear:

In the UK, that population should be allowed to stabilise and decrease by not less than 0.25% a year to an environmentally sustainable level, by bringing immigration into numerical balance with emigration, by making greater efforts to reduce teenage pregnancies, and by encouraging couples voluntarily to “Stop at Two” children.

Rosamund McDougall, policy director at the Trust, told us an environmentally sustainable population for the UK is in the 17-27 million range – on an “equal shares basis” applied to world resources. The only way any more people would be OK would be in the event of a “major breakthrough in renewable energy or food production”.

Asked if, say, fusion power would permit a relaxation, McDougall was highly sceptical. “They’ve been talking about that for 20 years,” she said, suggesting that a big increase in the efficiency of solar power was more plausible. But until that happens, the UK (and the rest of the world) should seek to seriously reduce its population.

Dr Hayes is certainly more than willing to advise her patients on matters that many would say are outside the remit of a GP. Her practice exhorts its patients not to fly on holiday, “but if you are flying this year, please consider offsetting your carbon emissions”. Dr Hayes also requests that her patients “will walk or cycle whenever possible”, so as not to damage the environment as well as for their own health. She herself is off on sabbatical to Madagascar and Australia – no doubt having offset the carbon from her flights.

The Register

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.

Joan Broner, like many people, never reads the fine print at her medical appointments. As a consequence, the 58-year-old San Francisco resident, who has arthritis, regularly receives solicitation letters at home from several local hospitals. The letters infuriate her.  “It feels like an invasion of privacy,” she said. “If I’m sick and I go to a doctor, I don’t want them telling anybody about it. My disease is not for sale.”

When patients check into hospitals or doctor offices, they presume their information will be kept in strictest confidence, but often, amid the pile of papers, they overlook fine print describing how their personal information can be farmed out for fundraising.

Hospitals and other health care organizations widely use patient information, without patients’ explicit permission, to raise funds. To the dismay of privacy-rights advocates and some in the medical field, fundraising to benefit medical institutions is allowed under federal law.  Patients can opt out – after the fact.

Critics say the practice of soliciting donations from current and former patients – no matter how worthy the beneficiary – symbolizes the erosion of personal privacy in contemporary life. To privacy advocate Dennis Melamed, the federal law has an egregious loophole. “It’s a big surprise to patients just how far and wide their data is going,” said Melamed, editor of the Health Information Privacy/Security Alert, a trade newsletter.

Fundraising efforts by UCSF led to a recent privacy breach involving more than 6,300 patients whose names and other information were inadvertently posted on the Internet – the institution had shared patient information with a vendor that searches databases to find wealthy potential donors.

Mark Laret, chief executive of the UCSF Medical Center, in an interview with The Chronicle, called the breach a “serious problem.” In its wake, fundraising practices are being re-examined, he said.

“I’m sorry that it happened,” he said. “This whole circumstance has caused us to take another look at the information we give patients and how we ask for their permission for nonmedical issues. Protecting privacy and confidentiality is among the most important things we do for everyone who comes to this medical center.”

UCSF received $252 million in private support during fiscal year 2006-07, a 25 percent increase over the prior year.

For Laret, the breach triggered an important question: Are patients given too much information to sort through at the time of admission?

Typically in medical settings, patients are handed booklets called “notice of privacy practices.” The documents explain the numerous ways patient information can be used, including fundraising to benefit the health care operation. When patients sign the statement, it’s an acknowledgement that they’ve received the information.

In the UCSF breach, the names of the patients and the medical departments where they were treated were shared with the vendor and exposed on the Internet along with the patients’ medical record numbers.

The information provided to the vendor exceeded what is permitted by federal law, which allows only patient “demographic information,” including name, address and dates of medical care, to be used for fundraising purposes without specific patient consent.

Fundraising: A critical need

With a third of the nation’s hospitals operating in the red and another third struggling to break even, fundraising has become an increasingly critical, fruitful endeavor. In 2006, $8 billion was raised through philanthropy by U.S. hospitals, medical centers, hospices and long-term-care facilities, an 11 percent increase over the previous year, says the Association for Healthcare Philanthropy, a not-for-profit organization that works with health care fundraisers.

Many hospitals rely on fundraising – what some development experts call “high touch direct mail” – to finance costly new equipment, a new wing, a chapel.

“It really helps hospitals in terms of getting equipment they couldn’t afford or it helps offset the amount of money they have to borrow,” said Jan Emerson, speaking for the California Hospital Association.

A Chronicle survey of a dozen Bay Area hospitals and medical centers found that the majority directly solicit current or former patients. “It is part of our culture in America,” said Bill McGinly, president and chief executive of the philanthropy association. “Universities and colleges have access to student records. Grateful patients are our alumni.”

Implemented in 2003, federal patient privacy provisions have made fundraising more restrictive, McGinly said. “Before, our members had access to patient records,” he said. The law set limitations. If a medical center wants to do targeted mailings to cardiac patients, for example, to help fund a new heart center, the patients’ direct authorization would be needed.

Research Professor Joy Pritts of the Center for Medical Record Rights and Privacy at Georgetown University’s Health Policy Institute believes the limitations are not enough. A more “respectful” approach, she said, would be to require a patient’s explicit consent before the patient’s data can be used for fundraising.

Patient privacy, said Pritts, “is about more than improper disclosures; it is also about patient control over how their information is to be used.”

“Some hospitals have started the practice of asking patients up front,” she said. “The benefit is when the patient receives the fundraising information, it is not a surprise. The argument against asking up front is that people might say no.”

McGinly said many hospitals are reluctant to seek written approval because “it becomes a tracking nightmare.” Typically, he said, hospitals do general appeals to all patients.

California’s privacy act

California has a medical privacy act “designed to prevent patients from being used as a marketing database,” said San Francisco attorney Khaldoun Baghdadi, who has handled claims from patients who believe their privacy has been violated. “If that medical information was disclosed negligently, each patient can be awarded $1,000 per violation.”

Patient privacy consciousness has heightened in recent years, say experts, in part because of the electronic explosion of information sharing.

Joanne McNabb, chief of the California Office of Privacy Protection, said that, as a basic principle, “information collected for one purpose shouldn’t be used for another without specific consent. If you are going to use it for a secondary purpose, you should disclose it.”

Some doctors believe that revealing any patient information, even for benevolent purposes, violates a relationship of trust.

“Patients are grateful – it is reasonable for hospitals to ask them to help out,” said Professor Robert Baker, head of the bioethics program at Union Graduate College in New York. “But it is impolite and erodes trust for hospitals not to ask specifically if patient information can be shared for fundraising.”

To Dr. Steven Fugaro, an internist and president of the San Francisco Medical Society, the matter raises ethical concerns.

“When you go to Macy’s or Wal-Mart or buy a car, it has come to be expected that your name will be used for commercial purposes,” he said. “But it seems to me that physicians and hospitals have higher standards. People come to us … because they are sick. They have an expectation that their names will be kept private, even the fact that they were treated by the doctor or hospital.

“I’m sure that the vast majority of patients are not aware that this is done.”

That was the case for Warren Lambert, a San Francisco resident whose name was part of the UCSF breach.

“I assumed my privacy was protected, but it wasn’t,” he said. “Their vendor pried into my personal financial matters for the direct benefit of UCSF. It is outrageous – and to me it is unethical.”