My Brain Made Me Do it Defense

by Peak Positions

Original article appeared in Reuters

A once respected paediatrician, loved by patients and their parents, today Domenico Mattiello faces trial for pedophilia, accused of abusing children in his care.

Scientific experts will argue in court that his damaged brain made him do it, and his lawyers will ask for leniency.

It's the latest example of how neuroscience - the science of the brain and how it works - is taking the stand and beginning to challenge society's notions of crime and punishment.

The issue has been thrown into the spotlight by new technologies, like structural and functional magnetic resonance imaging (MRI), positron emission tomography (PET) scans and DNA analysis, that can help pinpoint the biological basis of mental disorders.

A series of recent studies has established that psychopathic rapists and murderers have distinct brain structures that show up when their heads are scanned using MRI.

And in the United States, two companies, one called No Lie MRI and another called Cephos Corp, are advertising lie-detection services using fMRI to lawyers and prosecutors.

CRIME AND PUNISHMENT

While structural MRI scans show the structure of a brain and can highlight differences between one brain and another, PET and fMRI scans can also show the brain in action, lighting up at particular points when the brain engages in certain tasks.

But the dazzling new technologies and detailed genetic data leave unanswered the issue of whether criminal courts are the right place to use this new information.

"The worry is that the law, or at least some judges, might be so overawed by the technology that they start essentially delegating the decision about guilt to a particular form of test," commented a professor of neuroscience at Oxford University.

The lawyers for American serial killer Brian Dugan, who was facing execution in Illinois after pleading guilty to raping and killing a 10-year-old girl, used scans of his brain activity to argue he had mental malfunctions and should be spared the death penalty. In the event, Illinois abolished capital punishment while he was on death row.

In a court in the Indian city of Mumbai, a woman was convicted of murder based only on circumstantial evidence and a so-called brain electrical oscillations signature profiling (BEOS) test, the results of which prosecutors said suggested she was guilty.

The days when mental capacity for crime is argued over by psychiatrists unaided by sophisticated machinery - such as Friday's verdict that Norwegian mass killer Anders Behring Breivik was sane when he killed 77 people - look numbered.

"All sorts of types of neuroscience evidence are being used for all sorts of types of claims," said a professor of law at the University of Utah. "The question is, is this technology really ready for prime time, or is it being abused?"

"ACQUIRED PAEDOPHILIA"

In Mattiello's case, the neuroscientific evidence will come in the form of a full psychiatric and biological analysis including an MRI brain scan that shows a roughly four-centimeter tumour growing at the base of his brain.

This created pressure inside his skull and "altered his behaviour," said a molecular geneticist and psychiatrist at Italy's University of Pisa who is compiling an expert report on the 65-year-old.

"His previous behaviour was completely normal," she told Reuters. "He was a pediatrician for 30 something years and he saw tens of thousands of children and never had any problem. The question is why, at some point, did someone who has always behaved properly suddenly change so drastically?"

The doctor was arrested in Vicenza, northern Italy, more than a year ago and is undergoing cancer treatment after having the tumour removed. Pietrini is due to see him again next month to continue his assessment and see the effects of the treatment.

The case, which has yet go to court, is strikingly similar to another of "acquired pedophilia" dating back to 2002, in which a 40-year-old married American schoolteacher suddenly became obsessed with sex and began secretly to collect child pornography.

He was eventually removed from the family home for making sexual advances towards his step-daughter and convicted of paedophilia. But later medical examinations found he had an egg-sized tumour in a part of the brain involved in decision-making.

When the tumour was removed, the man recovered from his paedophilic tendencies and was able to return to his family.

Experts are generally agreed that conditions like psychopathy and paedophilia can't be "cured", but in this groundbreaking case it appeared that removing the tumour, and hence the pressure in the brain, may have re-established his ability to control impulses.

As in that case, specialists believed Mattiello's tumour "may well have played a role in altering his behaviour".

"This is what we will be arguing," they said. "But of course it will be for the judge to determine to what extent he believes this medical condition played a role."

An Oxford expert in the field, called such cases "startling."

"It makes one wonder about the notion of responsibility," he said in an interview.

IS "MY BRAIN MADE ME DO IT" A DEFENCE?

And when it comes to prison, should pedophiles, psychopaths and other violent criminals be punished less severely if their behaviour can be blamed on biology? Is "my brain made me do it" a defence that warrants recognition with lighter sentences, or even no jail time at all?

"(It) raises the whole issue of what you think sentencing is for," said the Oxford expert. "Is it about punishment? Is it about retribution? Is it about remediation and rehabilitation? Is it about protecting society? Well, to some extent it's about all of those things."

Recent evidence - from both real and hypothetical cases - suggests judges are sympathetic to neurobiological evidence as mitigation.

A study published in the journal Science this month showed that criminal psychopaths in the United States whose lawyers provide biological evidence for their brain condition are more likely to be sentenced to shorter jail terms than those who are simply said to be psychopaths.

For the study, researchers at the University of Utah tweaked the real-life case of Stephen Mobley, a 39-year-old American who was sentenced to death in 1994 after robbing a Domino's pizza place in Georgia and shooting dead the restaurant's manager.

At his trial, Mobley's lawyer presented evidence in mitigation showing the accused had a variant of a gene called MAO-A that has been dubbed the "warrior" gene after scientists found it was linked to violent behavior.

AGGRESSIVE GENES

In the Science study, judges were given a hypothetical case loosely based on Mobley's, where the crime was a savage beating with a gun, rather than a fatal shooting.

All the judges were told the defendant was a psychopath, but only half were given expert testimony on the genetic and neurobiological causes of his psychopathy. Those who got the neuroscientific evidence were more likely to give a shorter sentence - generally about a year less, the study found.

Pietrini worked on a similar real-life case in Italy in 2009 - thought to be one of the first criminal cases in Europe to use this type of neuroscientific evidence.

It involved Abdelmalek Bayout, an Algerian living in Italy, who was tried and convicted for fatally stabbing a man who teased him in the street.

After conducting a series of tests on the Algerian, Pietrini and colleagues said they had found abnormalities in imaging scans of his brain, and in five genes that have been linked to violent behaviour - including MAO-A.

A 2002 study led by researchers at the Institute of Psychiatry at King's College London linked low levels of MAO-A with aggressiveness and criminal behaviour in boys who were raised in abusive environments.

Bayout's lawyers got his sentence reduced by arguing that this and other bad genes had affected his brain and were partly to blame for the attack.

WHERE WILL IT END?

Experts say it's almost inevitable that neuroscience and law will become yet more intertwined. After all, while neuroscience seeks to find out how the brain functions and affects behavior, the law's main concern is with regulating behaviour.

Yet many are uneasy about the use in courts of law - and in matters of life and death - of basic science that is only just creeping out of the lab.

A professor of law at Stanford University pointed out that no scientific peer-reviewed studies have been published demonstrating that BEOS - the brain test used in the Mumbai case - actually works.

Others stress that while genes like MAO-A have been associated with violence, there are also plenty of people with similar genotypes who don't go out and kill, rape or abuse.

"Neuroscience is being used by serious scientists in real labs, but the people trying to apply it in courts are not those same people," said one expert. "So they're taking something that looks very objective, that looks like gold standard science, but then morphing it into a forensic use it wasn't developed for.

"This isn't snake-oil science. It's real science. But it's being misapplied."

A clinical senior lecturer in forensic psychiatry at Oxford University, says he's uncomfortable with the long-term implications and wonders where it will end.

There are already known biological bases for many brain disorders criminals suffer from, including drug addiction, alcoholism and antisocial personality disorder, which is thought to affect up to half of all those in prison.

"The problem here is where do we draw the line?" he asked, suggesting a slippery slope if psychopathy reduces a sentence. What other more common biological conditions might also be used in a defense? 

In Your Eyes: What They Reveal About Your Health

by Peak Positions

Story first reported from WSJ.com

As an ophthalmologist, David Ingvoldstad sees much more about his patients' health than just their eyes. Thanks to the clues the eyes provide, he regularly alerts patients to possible autoimmune diseases like rheumatoid arthritis and lupus, monitors progression of their diabetes and once even suspected—correctly, as it turned out—that a patient had a brain tumor on the basis of the pattern of her vision changes.

Because the body's systems are interconnected, changes in the eye can reflect those in the vascular, nervous and immune system, among others. And because the eyes are see-through in a way other organs aren't, they offer a unique glimpse into the body. Blood vessels, nerves and tissue can all be viewed directly through the eye with specialized equipment.

With regular monitoring, eye doctors can be the first to spot certain medical conditions and can usher patients for further evaluation, potentially leading to earlier diagnosis and treatment. Clots in the tiny blood vessels of the retina can signal a risk for stroke, for example, and thickened blood-vessel walls along with narrowing of the vessels can signal high blood pressure. In some cases, examining the eye can help confirm some of the diagnoses or help differentiate disorders from each other.

"There's no question the eye has always been the window to the body," says Emily Chew, deputy director of the epidemiology division at the National Eye Institute. She adds, "Anybody with any visual changes…should be seeing someone right away."

Scientists are working to advance their knowledge of what the eye can reveal about diseases. For instance, researchers are studying how dark spots on the back of the eye known as CHRPE, or congenital hypertrophy of the retinal pigment epithelium, are associated with certain forms of colon cancer, and how dementia-related changes are signaled in the eye, such as how the eye reacts to light. Other scientists, like Dr. Chew, are studying how to keep the eye healthier for longer, which could be good for the health of the eye as well as the rest of the body.

Companies are building enhanced technology that allow for better viewing of the eye. Scotland-based Optos, for example, created a machine that allows for better screening of the periphery of the retina. The machines can now be found in doctors' offices and research clinics. Instead of the typical 30-degree view of the eye, it offers a 200-degree view. Being able to see more of the periphery could mean earlier or more accurate diagnosis of various diseases and may also be coupled with intervention tools to improve treatment. Optos is currently funding a study of the use of retinal imaging to diagnose heart disease, according to Anne Marie Cairns, head of its clinical development.

The eye's job is to deliver vision by converting incoming light information into messages that the brain can understand. But problems in vision can indicate a problem outside of the eye itself.

One critical structure in the eye is the retina, which allows us to experience vision. It is made of brain tissue and contains many blood vessels. Changes in vessels in other parts of the body are reflected in the retina as well, sometimes more noticeably or sooner than elsewhere in the body.

The eyes can help predict stroke risk, particularly important to people with heart disease and other stroke risk factors. That is because blood clots in the arteries of the neck and head that might lead to stroke are often visible as retinal emboli, or clots, in the tiny blood vessels of the eye, according to the National Eye Institute.

The immune system's interaction with the eyes can be telling, too, yielding information about autoimmune diseases or infections in the rest of the body. Sometimes eye symptoms may appear before others, like joint pain, in patients.

For instance, inflammation in the optic nerve can signal problems in an otherwise healthy, young person. Along with decreased vision and sometimes pain, it can suggest multiple sclerosis. If the optic disc, a portion of the optic nerve, is swollen, and the patient has symmetrical decreased field of vision, such as a decreased right visual field in both eyes, they may need an evaluation for a brain tumor—a rare circumstance.

If immune cells like white blood cells are seen floating in the vitreous of the eye, it could signal a local eye infection or one that is spread throughout the body.

Diabetes is one disease that can cause major changes in the eye. In diabetic retinopathy, a common cause of blindness, blood vessels hemorrhage and leak blood and fluid. When blood vessels don't function properly, they can potentially cause eye tissue to be deprived of oxygen and to die, leaving permanent vision damage.

Also, in diabetic patients additional blood vessels may grow in the eye, anchoring themselves into the sticky gel known as the vitreous, which fills a cavity near the retina. This condition can cause further problems if the retina tears when it tries to separate from the vitreous—a common occurrence as people age—but is tangled by growth of new blood vessels.

Usually diabetic patients who come in for eye exams already know they have the disease, and the primary purpose of an eye exam is to make sure they don't have diabetic retinopathy or, if they did have it, that the condition hasn't progressed, say eye doctors like Dr. Ingvoldstad, a private practitioner at Midwest Eye Care in Omaha, Neb. But once in a while there is a patient who has noticed vision changes but didn't realize he or she had diabetes until alerted during an eye exam that there were signs of the eye disease that is consistent with the condition, he says.

The American Academy of Ophthalmology recommends eye examinations whenever individuals notice any vision changes or injury. Adults with no symptoms or known risk factors for eye disease should get a base line exam by age 40 and return every two to four years for evaluations until their mid-50s. From 55 to 64, the AAO recommends exams every one to three years, and every one to two years for those 65 and older.

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Doctors Target Gun Violence as a Social Disease

by Peak Positions

Story first reported from USA Today

MILWAUKEE – Is a gun like a virus, a car, tobacco or alcohol? Yes say public health experts, who in the wake of recent mass shootings are calling for a fresh look at gun violence as a social disease.

What we need, they say, is a public health approach to the problem, like the highway safety measures, product changes and driving laws that slashed deaths from car crashes decades ago, even as the number of vehicles on the road rose.

One example: Guardrails are now curved to the ground instead of having sharp metal ends that stick out and pose a hazard in a crash.

"People used to spear themselves and we blamed the drivers for that," said Dr. Garen Wintemute, an emergency medicine professor who directs the Violence Prevention Research Program at the University of California, Davis.

It wasn't enough back then to curb deaths just by trying to make people better drivers, and it isn't enough now to tackle gun violence by focusing solely on the people doing the shooting, he and other doctors say.

They want a science-based, pragmatic approach based on the reality that we live in a society saturated with guns and need better ways of preventing harm from them.

The need for a new approach crystallized last Sunday for one of the nation's leading gun violence experts, Dr. Stephen Hargarten. He found himself treating victims of the Sikh temple shootings at the emergency department he heads in Milwaukee. Seven people were killed, including the gunman, and three were seriously injured.

It happened two weeks after the shooting that killed 12 people and injured 58 at a movie theater in Colorado, and two days before a man pleaded guilty to killing six people and wounding 13, including then-Rep. Gabrielle Giffords, in Tucson, Ariz., last year.

"What I'm struggling with is, is this the new social norm? This is what we're going to have to live with if we have more personal access to firearms," said Hargarten, emergency medicine chief at Froedtert Hospital and director of the Injury Research Center at the Medical College of Wisconsin.

"We have a public health issue to discuss. Do we wait for the next outbreak or is there something we can do to prevent it?"

About 260 million to 300 million firearms are owned by civilians in the United States; about one-third of American homes have one. Guns are used in two-thirds of homicides, according to the FBI. About 9% of all violent crimes involve a gun — roughly 338,000 cases each year.

Mass shootings don't seem to be on the rise, but not all police agencies report details like the number of victims per shooting and reporting lags by more than a year, so recent trends are not known.

"The greater toll is not from these clusters but from endemic violence, the stuff that occurs every day and doesn't make the headlines," said Wintemute, the California researcher.

More than 73,000 emergency room visits in 2010 were for firearm-related injuries, the Centers for Disease Control and Prevention estimates.

Dr. David Satcher tried to make gun violence a public health issue when he became CDC director in 1993. Four years later, laws that allow the carrying of concealed weapons drew attention when two women were shot at an Indianapolis restaurant after a patron's gun fell out of his pocket and accidentally fired. Ironically, the victims were health educators in town for an American Public Health Association convention.

That same year, Hargarten won a federal grant to establish the nation's first Firearm Injury Center at the Medical College of Wisconsin.

"Unlike almost all other consumer products, there is no national product safety oversight of firearms," he wrote in the Wisconsin Medical Journal.

That's just one aspect of a public health approach. Other elements:

• "Host" factors: What makes someone more likely to shoot, or someone more likely to be a victim. One recent study found firearm owners were more likely than those with no firearms at home to binge drink or to drink and drive, and other research has tied alcohol and gun violence. That suggests that people with driving under the influence convictions should be barred from buying a gun, Wintemute said.

• Product features: Which firearms are most dangerous and why. Manufacturers could be pressured to fix design defects that let guns go off accidentally, and to add technology that allows only the owner of the gun to fire it (many police officers and others are shot with their own weapons). Bans on assault weapons and multiple magazines that allow rapid and repeat firing are other possible steps.

• "Environmental" risk factors: What conditions allow or contribute to shootings. Gun shops must do background checks and refuse to sell firearms to people convicted of felonies or domestic violence misdemeanors, but those convicted of other violent misdemeanors can buy whatever they want. The rules also don't apply to private sales, which one study estimates as 40% of the market.

• Disease patterns, observing how a problem spreads. Gun ownership — a precursor to gun violence — can spread "much like an infectious disease circulates," said Daniel Webster, a health policy expert and co-director of the Johns Hopkins Center for Gun Policy and Research in Baltimore.

"There's sort of a contagion phenomenon" after a shooting, where people feel they need to have a gun for protection or retaliation, he said.

That's already evident in the wake of the Colorado movie-theater shootings. Last week, reports popped up around the nation of people bringing guns to "Batman" movies. Some of them said they did so for protection.

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State Fair Officials Concerned About Swine Flu

by Peak Positions

Story first reported from USA Today

An outbreak of swine flu is prompting state and county fair officials in about a dozen states to check pigs for the disease and urge fairgoers to be extra cautious around the animals this summer.

The precautions — including hand-washing stations and warning signs for children, the elderly and expectant mothers — come at the height of the nation's agricultural fair season, when farm children exhibit their livestock for city dwellers and suburbanites to see and even pet.

The number of cases hit 162 Friday, an "extraordinary" increase from 13 swine flu cases for all of last season, says Lyn Finelli, an epidemiologist at the Centers for Disease Control and Prevention (CDC).

Most of the cases have emerged in the Midwest. Many were reported in children who had contact with pigs at fairs in Indiana and Ohio.

"We expect to continue to see cases as long as fair season continues," Finelli says of the flu strain H3N2v.

•In Indiana, which has a nation-high 129 cases reported, precautions at the state fair running until Sunday include hot-water hand-washing stations near food vendors and dozens of hand-sanitizing stations.

•In Ohio, which has 31 cases reported and 40 county fairs scheduled in the next two months, state agriculture officials are delivering signs urging visitors to wash their hands after petting animals. Members of 4-H or Future Farmers of America are warned not to sleep in pens with their animals.

•In Kentucky, veterinarians are refusing entry of pigs with symptoms such as coughing, sneezing or labored breathing into the state fair in Louisville, which will start Thursday.

Precautions also are being taken at fairs in Colorado, Illinois, Iowa, Kansas, Minnesota, Missouri and West Virginia.

The CDC warns people at high risk of the flu, such as those 65 or older, pregnant or with chronic conditions such as asthma or diabetes, to avoid contact with pigs entirely.

The flu isn't traveling from person to person, and it's safe to eat pork, the CDC says.

The outbreak doesn't appear to have dampened attendance.

Visiting animals remains "very popular," says Andy Klotz, spokesman for the Indiana State Fair. "This is their one chance, for many people, to get up close with barnyard animals."

The Ohio State Fair, which ran from July 25 to Aug. 5, had 804,306 attendees, the second-largest attendance since 2004.

"It's still safe to go to the fair, but we don't touch the pigs this year," says Erica Pitchford of the Ohio Department of Agriculture.

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Pfizer Pulls Plug on Failed Alzheimer's Drug Trial

by Peak Positions

Story first reported from USA Today

Pfizer Inc.'s decision to pull the plug this week on an experimental drug for Alzheimer's disease was a disappointment, but not a big surprise, say medical experts eager for a breakthrough.

Pfizer produces the experimental Alzheimer's drug bapineuzumab, which is given by infusion.

The company said Monday that the trial of bapineuzumab is being stopped in patients with mild to moderate symptoms after it failed to change cognitive and functional performances.

"The bottom line of this failed trial is this is part of the process of finding disease-modifying medications," says Bill Thies, chief medical and scientific officer for the Alzheimer's Association. "There will be quite a number of efforts to find the medication we need."

In the past few years, researchers have discovered that symptoms appear as late as seven to 15 years after the disease has started; that may be too late for drugs to make a difference. The current body of research urges starting trials before symptoms appear.

Pfizer did not say if it will continue studies on people with no symptoms.

The decision to terminate the testing of the intravenous drug follows an announcement from Pfizer on July 23 about another group of trials using the same treatment. Those trials also failed, but were done on patients with the ApoE4 gene, which put them at a higher risk of developing the disease. The second trial was done on people without the gene and was expected to have better results.

"We are obviously very disappointed in the outcomes of this trial," said Steven Romano, a spokesman for Pfizer, in a press release. "Yet these data, and the subgroup and biomarker analyses underway, will further inform our understanding of this complex disease and advance research in this field."

The government announced a bold plan in May to find a way to prevent the disease by 2025. The last drug to help manage the disease was developed nine years ago and only offers temporary treatment of symptoms that begin years after the disease takes hold. Meanwhile, 5.4 million people in the nation have the fatal illness, and numbers are expected to spike as the Baby Boomers age.

Pfizer and Janssen Al combined on the trials and will report on analysis of the data at a meeting in Stockholm in September.

Bapineuzumab is one of several experimental drugs designed to target amyloid plaques in the brain.

In attempting to understand how the disease progresses, one theory describes the plaques as a mechanism that attacks healthy brain cells, weakening them and eventually killing them. An amyloid drug would target the plaques, similarly to how a statin drug removes plaque from arteries to help prevent heart disease. The other study results are expected in the coming months.

"As we are learning, it is critical that future Alzheimer's drugs be tested in persons before symptoms have appeared and the damage to the brain is so extensive as to be irreparable," says George Vradenburg, chairman of UsAgainstAlzheimer's.

Several "prevention" trials are in development for patients who aren't showing symptoms. For example, The National Institutes of Health committed $16 million in May to a $100 million study to be done on family members who have a genetic predisposition to early onset Alzheimer's.

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Fresh Target in Hunt for a Migraine Cure

Story first reported from WSJ.com

The hunt is intensifying for new treatments for migraines, the common and debilitating headaches that have confounded scientists for decades.

Of greatest focus for researchers is a brain chemical known as CGRP, which appears to play a role in the transmission of pain, but not in other brain functions, such as cognition or mood. Researchers are trying a variety of experimental drugs to stop CGRP from working by blocking its receptors in the brain. Others are working on artificial antibodies that could soak up the chemical in the bloodstream or brain before it can trigger migraines.

The hunt is intensifying for new treatments for migraines, the common and debilitating headaches that have confounded scientists for decades. WSJ's Shirley Wang reports on the latest approaches. Photo: Getty Images

Experts say the need for new medicines to treat migraine pain once it begins is great because current drugs only provide some benefit for 50% to 60% of sufferers and can't be used in people with heart disease or who have had a stroke. Also, they aren't a cure, and in many cases, the headaches tend to come back within 24 hours.

There also is a separate category of preventive drugs, which tend to be used by a small proportion of people who suffer from more frequent or debilitating migraines.

"People need migraine drugs that have a rapid onset of action, that take the pain away and keep it away," says Richard Lipton, director of the Montefiore Headache Center in New York.

Headache disorders are among the most common medical conditions world-wide. More than 1 in 10 adults globally are affected by migraines, which can be incapacitating, according to the World Health Organization. International studies have found that 50% to 75% of adults have reported a headache in the past year, with up to 4% of the global population reporting having a headache in half or more of the days each month, WHO says.

There isn't such a thing as a "regular" headache, but rather more than 300 types, says David Dodick, a professor of neurology at the Mayo Clinic's branch in Phoenix and chairman of the American Migraine Foundation. People having migraines usually experience intense pain, sensitivity to light, dizziness and sometimes nausea and visual and sensory symptoms called auras. Two other major types of headaches are caused by tension or medication overuse.

Breaking the Headache Cycle

Nonsteroidal anti-inflammatory painkillers such as ibuprofen work for some migraine sufferers. But the class of migraine medicines that hit the market in the 1990s called triptans remain the best or only treatment option for many patients. Nevertheless, about half of sufferers don't respond to them or can't take them because of other health reasons.

CGRP, which stands for calcitonin gene-related peptide neurotransmitter, has long been thought to play a role in migraines, but for much of that time for the wrong reason. Part of the confusion was because of a misunderstanding of migraines themselves.

Why they occur still isn't clear, but specialists say they have recently begun to understand the migraine as a brain disorder and not a vascular disorder. Until about 12 years ago, they were believed to stem from constriction of blood vessels in the brain. The dilation of the vessels to compensate then led to the throbbing pain, so the thinking went.

Now, it appears more likely that migraines "hijack" the brain's normal pain circuitry, says Dr. Dodick. The brain's normal pain-sensory system, in which nerve endings send messages to the brain about a threat, goes awry in migraines.

Experts disagree about how a migraine is triggered, but the trigeminal nerve—an important pathway that carries sensory information about the face—and its connections to numerous other nerves and the brain appear to be responsible for transmitting the pain.

Researchers also have isolated certain genes that might be linked to a predisposition for migraines, Dr. Dodick says.

Triptans, which promote blood-vessel constriction and inflammation, block the release of CGRP in the trigeminal nerve. While CGRP does aid the blood-vessel dilation process, its role activating the nerves in the brain appears to be the key when it comes to migraine pain.

In the mid-1980s, Peter Goadsby, a neurologist and headache specialist at the University of California San Francisco, and his colleagues found that CGRP is released in migraines and that triptans decreased CGRP action.

Several researchers and companies have been trying to develop drugs that bind to the CGRP receptors to prevent the chemical from activating the pain network. But because CGRP has a complex receptor—the slot where the molecule must bind in order to initiate actions in the body—it took chemists 15 years to figure out how to block the effects of CGRP, and even longer to develop a compound that could be taken orally, says Dr. Goadsby.

Bringing to market CGRP blockers, or antagonists—the most advanced of the new drugs in development for migraines—has proved challenging. Several investigational compounds have been shown to be toxic to the liver, a challenge that highlights the difficulty in developing drugs for conditions that affect the brain.

CGRP antagonists don't appear to work as well as triptans, but the blockers have an advantage in they don't appear to cause cardiovascular complications, says Stephen Silberstein, a neurology professor and director of Thomas Jefferson University's Headache Center in Philadelphia.

"You trade one kind of risk for another," says Dr. Silberstein, who has served as an investigator on several companies' clinical trials.

Merck & Co. had a promising CGRP-receptor antagonist under development but discovered in late-stage clinical-trial testing that some patients experienced liver enzyme changes. In July of last year, the company said it was discontinuing development of the compound, telcagepant, after looking at all its trial data. Germany's Boehringer Ingelheim GmbH was also working on a CGRP antagonist but canceled development. A spokesman declined to comment.

Bristol-Myers Squibb Co. is conducting several early stage studies on CGRP antagonists and other companies are testing or may begin development of similar compounds as well.

Researchers and companies also are trying to develop artificial antibodies that, when injected, would glom onto CGRP in the bloodstream or brain, before it reaches the receptors in the brain, or by blocking the receptors.

Research into these biologic antibody-based approaches is at an earlier stage than the testing of antagonist drugs, but antibodies eventually might be able to block CGRP action regularly so that migraines don't ever begin.

"The CGRP story is a story of developing an acute treatment for migraine," says Dr. Goadsby. "But the antibody story is testing the larger idea [that] if you blocked continuously CGRP, would you have a preventive treatment."

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Exercise May Fight Depression in Heart Failure Patients

Story first reported from AJC.com

Exercise helps people with heart failure feel a bit better, physically and emotionally, a new study shows. It may also lower a person's risk of dying or winding up in the hospital.

WebMD For some people, exercise works as well or even better than antidepressants. And you don't have to run a marathon. Just take a walk with a friend. As time goes on, increase activity until you exercise on most days. You'll feel better physically, sleep better at night, and improve your mood.

Up to 40% of people with heart failure grapple with depression . The combination often leads to poor health outcomes. One study found seriously depressed people with heart failure were more than twice as likely to die or be hospitalized over the course of a year compared to other people with heart failure who weren't depressed.

"Whenever patients are more depressed, their motivation goes down. Their ability to keep up with their doctors' recommendations goes down. Their ability to get out and do basic physical activities like walking goes down," as does their health, says David A. Friedman, MD, chief of Heart Failure Services at North Shore-LIJ Plainview Hospital in New York. "It's a vicious cycle."

"This [study] ... shows a non-drug way to try to improve patients' mood and motivation. That's the best thing you can do," says Friedman, who was not involved in the research.

Testing Exercise for Depression

For the study, which is published in the Journal of the American Medical Association, researchers assigned more than 2,322 stable heart failure patients to a program of regular aerobic exercise or usual care. Usual care consisted of information on disease management and general advice to exercise.

The exercise group started with a standard exercise prescription for patients in cardiac rehab: three 30-minute sessions on either a treadmill or stationary bike each week. After three months, they moved to unsupervised workouts at home. At home, their goal was to get 120 minutes of activity a week.

Just as happens in the real world, most exercisers fell short of their weekly goals.

Despite the fact that they weren't as active as they were supposed to be, they still had slightly better scores on a 63-point depression test than the group assigned to usual care. There was a little less than a one-point difference between the two groups. But the differences persisted even after a year, leading researchers to think the result wasn't a fluke.

And the exercisers were about 15% less likely to die or be hospitalized for heart failure compared with the group getting usual care.

Researchers think the differences between the two groups were small because most people in the study weren't depressed to begin with. Only 28% had test scores high enough to indicate clinical depression.

But the more depressed a person was, the more they had to gain from regular exercise. After a year, test scores of depressed patients were about 1.5 points better in the exercise group compared to those assigned to usual care.

"We know that exercise is beneficial in terms of improving cardiovascular fitness. Now we know depression is also reduced in these patients," says researcher James A. Blumenthal, PhD, a professor of psychology and neuroscience at Duke University in Durham, N.C.

"For people who were more depressed, they experienced a greater reduction in their depressive symptoms with exercise," he says.

The study shows exercise "is in the same ballpark" as other established treatments, particularly antidepressant medications, Blumenthal tells WebMD.

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Thousands Await Testing for Hepatitis by ‘Infector’

 Story first reported from nytimes.com

BOSTON — Thousands of former patients at a New Hampshire hospital must wait at least another week to learn if they were infected with hepatitis C through syringes used by a traveling medical technician now known as the “serial infector.”

Testing will be delayed as officials continue to try to develop an orderly process that will allow patients from the Exeter Hospital to be tested quickly and without having to wait too long in line, said Dr. José Montero, director of the state health department’s division of public health.

“Several groups are working on the approach,” he said in an interview on Wednesday. He said that he hoped to announce a plan by the end of this week and that testing could begin next week.

The New Hampshire health department announced last month that it intended to test more than 3,400 people who had been hospitalized while the technician, David Kwiatkowski, 32, who is believed to have contracted the disease at least two years ago, was working at Exeter Hospital, and it planned to set up mass clinics last weekend at the local high school. Mr. Kwiatkowski was charged with federal drug crimes last month, accused of stealing drugs and injecting himself with syringes that were later used on patients.

But officials pulled the plug on the plan after several former patients complained about the lack of privacy in a mass clinic setting. There were also questions of liability for the volunteers taking blood in such a setting.

Mr. Kwiatkowski has worked at an estimated 13 hospitals in eight states and potentially could have infected thousands of patients.

Already, patient advocates are pushing for ways to tighten the rules regarding such technicians to try to prevent cases like this from happening again.

Elenore Casey Crane, a former state representative in New Hampshire and co-founder of a group called The Patients Speak (www.hepcvictimsnetwork.com), is calling for a national registry to which hospitals and staffing agencies would be required to report issues of professional misconduct by medical technicians. She said that at the moment, beyond calling previous employers for a reference check, hospitals have no way of knowing whether a technician has previous violations.

Ms. Crane said she was meeting next week with representatives of Senator Kelly Ayotte, Republican of New Hampshire, to discuss federal legislation to establish such a registry.

Her group is also calling for national licensing of all medical technicians; licensing requirements now vary from state to state. And it has also prompted legislators in the eight states involved to file bills to require random drug testing of technicians at hospitals twice a year.

“Why does the guy who loads your car at Home Depot have drug testing and the men and women with you in the operating room do not?” Ms. Crane said. Her goal is nothing short of changing what she said was the culture of secrecy around medical workers.

In addition, her group has set an informational meeting for Tuesday at Exeter to discuss the medical and legal issues surrounding the outbreak.

Triage Staffing Inc., of Omaha, the agency that placed Mr. Kwiatkowski in many of his more recent jobs, has been sued by Domenic Paolini, a malpractice lawyer and former cardiac surgeon in Boston, on behalf of several patients. He has filed a class-action lawsuit on behalf of people whom the health department has recommended be tested, as well as infected patients.

Dr. Montero said Wednesday that almost 1,300 people had been tested, including many hospital employees.

About 30 people who tested positive with strains of hepatitis C matched the strain found in Mr. Kwiatkowski. Fourteen others tested positive but were not a match.

Originally the health department said that 6,000 people would have to be tested but found some names were duplicates.

The F.B.I., the Food and Drug Administration, the Centers for Disease Control and Prevention, the United States attorney in New Hampshire and various other agencies are investigating the case.

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Survival Rate Lengthened by Drug Duo

Story first reported from seattletimes.com

Women with metastatic breast cancer treated with a combination of two estrogen-blocking drugs survived more than six months longer than those treated with just one of the drugs or one followed by the other, according to a study involving nearly 700 women.

It's the first time such improvement in overall survival has been seen in trials of first-line hormonal therapy for hormone-receptive metastatic breast cancer, the study authors said.

"We're finding a lot of other ways of treating these estrogen-receptor-positive breast cancers that don't include chemotherapy," said co-author Dr. Julie Gralow, director of breast medical oncology at Seattle Cancer Care Alliance.

Such hormone-targeting therapy is a key focus in breast-cancer research, in part because it avoids the toxic effects of chemotherapy, Gralow said. However, she cautioned, these first results need to be repeated and verified by other researchers and may only apply to a subgroup of women with this type of breast cancer.

The report, from the University of Michigan-based research group SWOG, one of five cooperative groups that comprise the National Cancer Institute's National Clinical Trials Network, was published Wednesday in the New England Journal of Medicine.

The SWOG Statistical Center is based at Fred Hutchinson Cancer Research Center; and co-authors also include Dr. William Barlow, professor of biostatistics at the University of Washington.

The two drugs, anastrozole (brand name Arimidex) and fulvestrant (brand name Faslodex), are both called endocrine therapies because they work through action on a hormone — in this case, estrogen. About three-quarters of women with breast cancer and metastatic breast cancer have tumors that are responsive to estrogen, Gralow said. Anastrozole inhibits estrogen synthesis, while fulvestrant works on estrogen receptors.

The combination therapy increased the median survival of the women in the trial by 6.4 months compared with those who took only anastrozole. The combination also lengthened by 1.5 months the time before patients' disease progressed. More than 40 percent of the women in anastrozole-only group switched to fulvestrant when their disease progressed.

Although at this point metastic breast cancer isn't cured with such endocrine therapies, Gralow said researchers are making a lot of progress in this area.

"We're trying to get away from toxic, nonspecific therapies, like chemotherapy, and better understand how we can affect the estrogen receptors and its pathways and get even better results than with chemo, with fewer side effects. That's where we're going in treating breast cancer."

About 700 women with metastatic breast cancer were enrolled in the study. Gralow said she was surprised to find that nearly 40 percent of them had received no treatment for breast cancer before coming in for evaluation of a breast lump and being informed their cancer had already spread.

"When I first saw that I didn't believe it," Gralow said. While such late diagnosis is common in the rest of the world, she said, it's troubling to see so many women from this country whose breast cancer was not caught in the early stages.

"That means there are a lot of those patients out there," she said.

For the study, having such a large percentage of previously untreated patients may mean the results would not hold for women who had received estrogen-blocking drugs in the past, Gralow said. "What the results mostly relate to is a patient who is just starting endocrine therapy for the first time," she said.

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Michigan Woman Dies From Flesh-Eating Bacteria

Story first reported from USA Today

FARMINGTON HILLS, Mich. -- Twelve days after doctors told a woman that she was finally clear of a life-threatening flesh-eating bacteria infection, she took a turn for the worse and died.

Crystal Spencer, 33, had spent a month in and out of three hospitals. Her husband had been visiting a rehabilitation hospital Sunday where she was about to be transferred when the hospital called and told him to return immediately.

A team of eight doctors worked for more than an hour to resuscitate his wife, amid alarms indicating she was near death three times. She died at 3:36 p.m. Sunday.

The family is raising money to conduct an autopsy to find out as much as they can about what happened. Results could take several weeks.

Until about a week ago when they learned that their application for Medicaid had been approved, the Spencers had limited health insurance. Now Jeff Spencer said he has thousands of dollars in medical debt from care not covered by insurance.

Crystal Spencer was a high school dropout and had been poor and underinsured or uninsured most of her life. She had adult-onset diabetes and weighed more than 300 pounds all of her adult life, factors that put her at higher risk of contracting the flesh-eating bacteria.

Her death from necrotizing fasciitis has drawn national attention to a rare disease many had never heard of and others knew only by its scary name: the flesh-eating bacteria.

Nationwide, the U.S. Centers for Disease Control and Prevention has reported 500 to 1,500 cases a year; 1 in 5 people dies from it. Many others have fingers, toes or limbs amputated because the bacteria eats away at underlying layers of tissue.

Many cases are misdiagnosed or found late, according to the National Necrotizing Fasciitis Foundation, a nonprofit founded by two women who survived the infection.

The foundation hopes to raise awareness about a problem that needs more education and hospital early intervention programs so symptoms can be caught and treated with antibiotics or the removal of dead skin and infected tissue, a procedure called debridement. Others need surgery, including extensive skin grafts.

Too often, patients get the wrong treatment because the infection is misdiagnosed, according to the foundation

Jeff Spencer said doctors at Huron Valley-Sinai in Commerce Township, Mich., originally had told him his wife had a urinary tract infection. At Botsford Hospital here, where she first sought care June 23 for what she thought was a boil on her upper right thigh, an emergency department physician lanced the protruding tissue and sent her home with a Motrin prescription, said Theresa Corwin of Farmington Hills, a close friend.

She and Spencer blame Botsford for not running blood tests to see whether white blood cell counts were elevated, a sign of infection.

They also wonder why a doctor there called the infected area on her leg an "abscess" -- an accumulation of pus and tissue triggered by an infection -- but gave them no warning that Crystal Spencer might be contagious. Corwin, who said she is certified in CPR and first aid, was given the job of cleaning the wound and changing the dressings four to five times a day when her friend got home.

On Monday, Botsford spokeswoman Margo Gorchow said it was unlikely that Crystal Spencer contracted necrotizing facitiitis there because the infection typically is not acquired in a hospital, and the woman had none of its symptoms when she came to the emergency department.

A spokeswoman for Huron Valley-Sinai declined comment both Monday and Tuesday, citing patient privacy laws.

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