MONDAY, Nov. 19 (HealthDay News) -- People who suffer from repeated migraines have a thickening in an area of their brains that's involved in processing pain, researchers report.

But exactly what this means, or whether the migraines or the brain-thickening come first, is not yet clear.

"We don't know if it's a cause or a consequence" of migraines, said study senior author Dr. Nouchine Hadjikhani, an associate professor of radiology at the Martinos Center for Biomedical Imaging, affiliated with both the Massachusetts General Hospital and Harvard Medical School.

"What we need is more people and also more time points. If we could follow people over a few years of migraines and see if we can see changes going one direction or the other, that would be something in the direction of an answer," she said. "For the moment, we have one snapshot in time. We see a difference. We don't know why."

"The authors suggested that it may be that repeated attacks of migraine lead to the changes in the brain, although another possibility is that these alterations in the brain structure predispose to migraine," added Dr. Richard Lipton, director of the Montefiore Headache Clinic in New York City. "I have a bias in favor of the hypothesis they present -- that recurrent migraines alter the brain --- because I want to believe that if patients get treated with preventive medication and acute treatments, maybe this thickening could be prevented."

The study is published in the Nov. 20 issue of Neurology.

Some 28 million Americans suffer from migraines, debilitating headaches that usually strike on one side of a person's head and can also involve nausea, vomiting and sensitivity to light. Some migraines are accompanied by "aura," or changes in vision.

Previous researchers have noted changes in the frontal and temporal cortices of the brain in individuals with chronic pain disorders, such as migraine and back pain.

Hadjikhani and her colleagues had previously found changes in the brain's white matter (which consists of nerve fibers) in people suffering from migraines.

"We found changes in migraineurs compared to controls in the white matter pathways that are important for the somatosensory processing of pain," she explained. "That's why we decided to look at cortical thickness, to see if white matter had any bearings on the gray matter [which consists of cell bodies]."

The somatosensory system includes sensations from the body -- including touch, pain and pressure -- that do not involve the organs devoted to sense, such as the eyes and ears.

The researchers used brain scanning to examine 24 people with migraine, 12 with aura and 12 without. They then compared those scans to scans of 12 people without migraine.

The cortical thickness of the somatosensory cortex area (SSC) of the brain was an average of 21 percent thicker in individuals with migraine, the team found.

It's not clear why this thickness varies in people with and without migraines.

"The brain is a plastic organ, and its structure can change depending on whether you're using it or not," Hadjikhani said. "Now, the question is, do we see the increase in thickness because we have repetitive attacks of migraine? That's our interpretation. The idea is, if you are stimulating this system three or four times a month since you were a teenager, maybe it makes it bigger."

And changes in the brain induced by repetitive migraine attacks may make sufferers more prone to suffering from other pain disorders, the researchers theorized. This would explain the high number of people with migraine who also suffer from such conditions as fibromyalgia and back pain.

More information

There's more on migraine at the National Headache Foundation  .

TUESDAY, Nov. 13 (HealthDay News) -- Regulators may be going too far in their efforts to protect human research subjects, a new survey of research scientists suggests.

Two-thirds of doctors recently surveyed said that the Health Insurance Portability and Accountability Act (HIPAA), which oversees the release of patients' medical information, has hindered research. Only one-quarter felt the new rules had actually enhanced patients' confidentiality and privacy.

"According to the scientists surveyed, HIPAA is slowing and adding cost to clinical and population research. This has the potential to delay important research findings," said Dr. Roberta B. Ness, the study's lead author and chair of the department of epidemiology at the University of Pittsburgh Graduate School of Public Health.

"The pendulum has been swinging for decades and is continuing at light speed. There is no sign of it swinging back," added Dr. Norman Fost, author of an accompanying editorial and chair of the Institution Review Board at the University of Wisconsin School of Medicine and Public Health in Madison.

The study is published in the Nov. 14 issue of the Journal of the American Medical Association.

The original intent of the 1996 HIPAA Privacy Rule was to allow consumers to carry their insurance from job to job. But the final version tilts more toward protecting the privacy of medical records and information.

"Currently, an Institute of Medicine/National Academies panel is considering what suggested actions should be taken," Ness noted. "These may include suggesting changes in the rule or better guidance and implementation. That report should be out next summer or fall."

According to background information in this paper, HIPAA was supposed to find a balance between protecting individuals' privacy and allowing the use and disclosure of the information for social goals.

The rule allows health-care provider organizations to disclose individual information for research purposes, but only if the researcher gets written consent from each patient or obtains a waiver of the requirement.

There has been some evidence that HIPAA has slowed or even halted research, but there have been no large, generalized studies until now.

This study, commissioned by the Institute of Medicine, is based on surveys filled out by more than 1,500 epidemiologists conducting research on U.S. human subjects.

More than two-thirds (about 68 percent) of respondents said that the HIPAA Privacy Rule has made research more difficult at a level of 4 to 5 on a 5-point scale (5 indicating a great deal of added cost and time to complete a study).

Almost 40 percent said HIPAA had increased research costs in the high range, and half said that a high degree of additional time was now needed to complete research projects.

Almost half felt that the rule had greatly affected research related to public health surveillance.

Only 10.5 percent of respondents indicated that the rule had strengthened public trust, and only about 26 percent felt the rule enhanced participant confidentiality and privacy to a great degree.

Respondents also felt that the privacy rule had a negative influence on human subjects' protection more often than it had a positive influence.

"The one positive was that 25 percent felt that HIPAA had increased privacy," Ness said.

An accompanying editorial described a system mired in minutiae, including requirements for meticulous documentation.

The solution?

"The research community needs to push back. It needs to stop just caving in," said Fost, who is also professor of pediatrics and founder/director of the bioethics program at Wisconsin and who has received national recognition for his efforts to protect human research subjects. "It may be that there needs to be litigation," he said.

And, added Fost, "the basic structure [for research] that is already in place is very good. There's no question that the profession was not doing a good job on their own, and they needed to be forced to set up IRBs [institutional review boards] and make them work. But in 1983, a presidential commission concluded that the system was working very well."

More information

To learn more about HIPAA, visit the U.S. Department of Health and Human Services.

WEDNESDAY, Oct. 24 (HealthDay News) -- Serious medical errors don't just affect the health of the patient, they can quickly destroy the patient's relationship with his or her doctor, too, experts say.

Too often, a health care mistake causes shame and fear in the physician responsible, leading to stilted, unsatisfying conversations with -- or avoidance of -- the affected patient, say the authors of an article in the Oct. 25 New England Journal of Medicine.

All of this can quickly move patient and doctor into an adversarial or litigious position.

But that's not always necessary, said one of the article's co-authors.

"Trust is an enormously important part of medicine -- if people aren't straight with you, you do not trust them," said Dr. Tom DelBanco, a professor of general medicine and primary care at Harvard Medical School.

"So, being upfront and honest, indicating that you want to do something about what happened, makes all the difference in the world," said Delbanco, who co-wrote the article with Harvard colleague Dr. Sigall Bell.

In many cases, doctors who frankly admitted their mistake and told patients how they would safeguard against future errors avoided litigation by doing so, Delbanco said. Those doctors also maintained strong, long-lasting bonds with the patient and the patient's family.

According to Delbanco, several patients interviewed for the article (and a related film) said that, " 'We don't expect you to be perfect, everybody makes mistakes. We just want you to be honest when it happens. We can deal with that.' "

In fact, "There are now some malpractice [insurance] companies that teach doctors to be honest and open," Delbanco noted. "There is slowly growing evidence that it may actually prevent lawsuits."

Medical errors have gotten a lot more attention recently, ever since the U.S. Institute of Medicine issued its 1999 report, To Err is Human. That report estimated that the deaths of more than 100,000 Americans each year are tied to some form of medical mistake.

In the wake of such errors, doctors often feel shame and guilt, as well as fear linked to the looming threat of lawsuits. For legal reasons, "I think that doctors are very confused about what they can and cannot say" to patients after an error comes to light, Delbanco said. That includes the use of simple words such as "mistake," "error," or even "I'm sorry."

"It depends on their institutions' views, it depends on the lawyers that they may or may not talk to," Delbanco said. "Very often, they are not only confused, but depressed, because they feel like they cannot say what they really feel like saying."

People who care deeply for a patient affected by a medical mistake often shoulder their own level of guilt after the incident. "Family members, in particular, can feel extraordinary guilt," Delbanco said, and often berate themselves, thinking, " 'If I had done this, this wouldn't have happened,' 'If I had been there, I would have prevented it,' 'If only I had been more forceful, the doctor wouldn't have done this.' "

Such was the case for those close to a young man with sickle cell anemia, mentioned in the NEJM article. The unnamed patient received morphine while in the hospital -- despite a well-documented allergy to the painkiller. He slipped into kidney failure and coma soon after, and his sister said she felt as if she "failed her family in terms of 'I should have been there.' That's a guilt that everyone shares."

Doctors who acknowledge that a mistake has happened, and outline steps to prevent such mistakes going forward, can ease a lot of distress for themselves and the patient, experts say.

But, in many cases, physicians have "a lack of confidence in their communication skills -- they just aren't sure how to have these conversations," said Dr. Thomas Gallagher, associate professor of medicine at the University of Washington School of Medicine, in Seattle.

Gallagher said Delbanco's and Bell's article echoes the findings of studies he has led, which revealed profound differences in the ways doctors and patients communicated after a serious medical error.

But he also believes the landscape around medical errors is changing. Already, about 30 states have enacted so-called "I'm sorry" laws, which, to a certain degree, make a doctor's apology for an error inadmissible in a court of law.

That should help ease patient-doctor conversations. But Gallagher said many of these laws still "provide very little protection for clinicians. They allow you to say 'I'm sorry,' but they don't allow you to make any expression that a mistake happened or to admit liability."

And, he said, it's not entirely clear that admitting to mistakes always wards off a lawsuit. "It's not a magic bullet," Gallagher said. "There will clearly be some cases where disclosure is what precipitates a lawsuit."

So, work remains to be done in finding strategies that allow patients and doctors to remain close even after a mistake occurs.

For his part, Delbanco said he is currently screening his film for third-year students at Harvard Medical School -- at the request of the school's dean -- to help them become better physicians. "Traditionally, there's been little coaching in this area," he said. "That's changing."

His advice to patients: If a serious medical error occurs, "be very aggressive in asking for communication. Patients should not be afraid of opening their mouths." And if that communication is not forthcoming, "Ask why and with whom can they speak?" he said.

And a hasty "I'm sorry" from a physician may not always be adequate, Delbanco added.

"Apology only means something when you show what you are going to do for that person -- and for the next person," he said. "Otherwise, they are just words."

More information

There's more on preventing medical errors at the U.S. Agency for Healthcare Research and Quality.

TUESDAY, Oct. 16 (HealthDay News) -- More than half of department chairs at U.S. medical schools and teaching hospitals have financial ties with the drug industry, a new study finds.

These institutional relationships seemed to be just as widespread as those of individual physicians or scientists with industry.

"There is not a single aspect of medicine in which the drug companies do not have substantial and deep relationships, affecting not only doctors-in-training, resident physicians, researchers, physicians-in-practice, the people who review drugs for the federal government and the people who review studies," said lead researcher Eric Campbell, associate professor at the Institute for Health Policy at Massachusetts General Hospital and Harvard Medical School in Boston.

"Drug companies have relationships with everyone," he continued. "They're involved in every aspect of medicine. Someone has to decide which of these is OK."

The study, the first to examine the extent of these institutional relationships, is published in the Oct. 17 issue of the Journal of the American Medical Association.

Although Campbell himself reported no financial conflicts, one co-author did report having served as a consultant for drug makers Genentech and GlaxoSmithKline.

"I think the paper is a very valuable contribution, in that it provides what's probably the first comprehensive documentation of the extent of relationships that involve department chairs, and department chairs are certainly the key agents of overseeing and maintaining the day-to-day operations of a medical school or teaching hospital," said Dr. David Korn, senior vice president, division of biomedical and health sciences research at the Association of American Medical Colleges in Washington, D.C. "The extent of the relations is not surprising," added Korn, who was not involved with the study.

He said his association has already established a task force that's looking into the broad issues of industry support of medical education, which is not necessarily detrimental.

"Supported research is fulfilling a social mandate," he said. "After all, the public support of NIH [U.S. National Institutes of Health] funding is really driven by the desire to see practical results . . . and the only way those practical results can come to pass is by having productive relationships between the discoverers of new information and the organizations that our country has established to determine whether that information can be developed into useful products for public health."

The issue of medicine's ties to industry has been a hot one of late.

One study found that third-year medical students get, on average, one gift or attend one activity sponsored by a drug maker each week. This type of marketing by pharmaceutical companies apparently begins before students enter medical school, in the weeks and months after students graduate from college.

There have also been calls recently by some doctors and academic leaders for a ban on all pharmaceutical gifts, including free meals, to doctors at academic medical centers.

There is, however, no national data to describe the extent of these institutional academic-industry relationships.

To help supply that data, Campbell and his colleagues surveyed the department chairs of 125 accredited medical schools and the 15 largest independent teaching hospitals in the United States. Of 688 eligible chairs, 459 completed the survey, for a response rate of 67 percent.

Sixty percent of department chairs reported some form of personal relationship with industry such as being a paid consultant (27 percent), a member of a scientific advisory board (27 percent), an officer or executive of a company (7 percent), a founder of a company (9 percent), a member of a board of directors (11 percent) or a paid speaker (14 percent).

Chairs of clinical departments -- such as medicine and psychiatry -- were more likely to have served on a speakers' bureau than chairs of nonclinical departments -- such as microbiology.

Two-thirds of departments had relationships with industry, with clinical departments more likely than nonclinical department to receive research equipment (17 versus 10 percent), unrestricted funds (19 percent versus 3 percent), research seminar support (36 percent versus 13 percent), support for residency and fellowship training (37 percent versus 2 percent) and support for department-administered continuing medical education (65 percent versus 3 percent).

Clinical departments were also more likely to receive funds to buy food and beverages, support for professional meetings and subscriptions to professional journals.

"I have a master's degree in adult education and curriculum instruction and in my schooling, I don't ever remember learning that the first thing you do is pass out food sponsored by the companies whose products you're about to teach about," said Campbell. "A very large percentage of medical departments report getting money for food and beverages from drug companies. It's nice to have but, in the end, it's not necessary. It's not a principle of good education as far as I know."

More than two-thirds of department chairs felt that having a relationship with industry had no effect on their professional activities, while 72 percent thought that a chair engaging in more than one industry-related activity had a negative impact on a department's ability to carry out independent research.

"Now it's up to the policymakers and people who run medical schools," said Campbell. "They need to come up with some rules and they need to be new rules. I believe there's very little reasonable justification for why drug companies should be involved in the education of medical students. What knowledge do they have that is not currently available in the biggest medical schools in the country?"

More information

To learn more, visit the Institute on Medicine as a Profession  .