September is Pain Awareness Month

The month of September has been declared Pain Awareness Month.  Pain Awareness Month is a time when various organizations work to raise public awareness of issues in the area of pain and pain management. 

The first Pain Awareness Month was in 2001, when the ACPA led a coalition of groups to establish September as Pain Awareness Month.  ACPA established Partners for Understanding Pain and 80 organizations, both health care professionals and consumer groups, including the NAACP supported the effort. 

The key to raising awareness is to get involved.   There are many things that you can do to help promote Pain Awareness Month more ...

These days it is easy to get irritated with the exaggerated interpretations of brain imaging — for example, that a single fMRI scan can reveal our innermost feelings — and with inflated claims about our understanding of the biological basis of our higher mental processes.

Such irritation has led a number of thoughtful people to declare that we can never achieve a truly sophisticated understanding of the biological foundation of complex mental activity.

In fact, recent newspaper articles have argued that psychiatry is a “semi-science” whose practitioners cannot base their treatment of mental disorders on the same empirical evidence as physicians who treat disorders of the body can. The problem for many people is that we cannot point to the underlying biological bases of most psychiatric disorders. In fact, we are nowhere near understanding them as well as we understand disorders of the liver or the heart.

But this is starting to change.

Consider the biology of depression. We are beginning to discern the outlines of a complex neural circuit that becomes disordered in depressive illnesses. Helen Mayberg, at Emory University, and other scientists used brain-scanning techniques to identify several components of this circuit, two of which are particularly important.

One is Area 25 (the subcallosal cingulate region), which mediates our unconscious and motor responses to emotional stress; the other is the right anterior insula, a region where self-awareness and interpersonal experience come together.

These two regions connect to the hypothalamus, which plays a role in basic functions like sleep, appetite and libido, and to three other important regions of the brain: the amygdala, which evaluates emotional salience; the hippocampus, which is concerned with memory; and the prefrontal cortex, which is the seat of executive function and self-esteem. All of these regions can be disturbed in depressive illnesses.

In a recent study of people with depression, Professor Mayberg gave each person one of two types of treatment: cognitive behavioral therapy, a form of psychotherapy that trains people to view their feelings in more positive terms, or an antidepressant medication. She found that people who started with below-average baseline activity in the right anterior insula responded well to cognitive behavioral therapy, but not to the antidepressant. People with above-average activity responded to the antidepressant, but not to cognitive behavioral therapy. Thus, Professor Mayberg found that she could predict a depressed person’s response to specific treatments from the baseline activity in the right anterior insula.

These results show us four very important things about the biology of mental disorders. First, the neural circuits disturbed by psychiatric disorders are likely to be very complex.

Second, we can identify specific, measurable markers of a mental disorder, and those biomarkers can predict the outcome of two different treatments: psychotherapy and medication.

Third, psychotherapy is a biological treatment, a brain therapy. It produces lasting, detectable physical changes in our brain, much as learning does.

And fourth, the effects of psychotherapy can be studied empirically. Aaron Beck, who pioneered the use of cognitive behavioral therapy, long insisted that psychotherapy has an empirical basis, that it is a science. Other forms of psychotherapy have been slower to move in this direction, in part because a number of psychotherapists believed that human behavior is too difficult to study in scientific terms.

______

Any discussion of the biological basis of psychiatric disorders must include genetics. And, indeed, we are beginning to fit new pieces into the puzzle of how genetic mutations influence brain development.

Most mutations produce small differences in our genes, but scientists have recently discovered that some mutations give rise to structural differences in our chromosomes. Such differences are known as copy number variations.

People with copy number variations may be missing a small piece of DNA from a chromosome, or they may have an extra piece of that DNA.

Matthew State, at the University of California, San Francisco, has discovered a remarkable copy number variation involving chromosome 7. An extra copy of a particular segment of this chromosome greatly increases the risk of autism, which is characterized by social isolation. Yet the loss of that same segment results in Williams syndrome, a disorder characterized by intense sociability.

This single segment of chromosome 7 contains about 25 of the 21,000 or so genes in our genome, yet an extra copy or a missing copy has profound, and radically different, effects on social behavior.

The second finding is de novo point mutations, which arise spontaneously in the sperm of adult men. Sperm divide every 15 days. This continuous division and copying of DNA leads to errors, and the rate of error increases significantly with age: a 20-year-old will have an average of 25 de novo point mutations in his sperm, whereas a 40-year-old will have 65. These mutations are one reason older fathers are more likely to have children with autism and schizophrenia.

Our understanding of the biology of mental disorders has been slow in coming, but recent advances like these have shown us that mental disorders are biological in nature, that people are not responsible for having schizophrenia or depression, and that individual biology and genetics make significant contributions.

The result of such work is a new, unified science of mind that uses the combined power of cognitive psychology and neuroscience to examine the great remaining mysteries of mind: how we think, feel and experience ourselves as conscious human beings.

This new science of mind is based on the principle that our mind and our brain are inseparable. The brain is a complex biological organ possessing immense computational capability: it constructs our sensory experience, regulates our thoughts and emotions, and controls our actions. It is responsible not only for relatively simple motor behaviors like running and eating, but also for complex acts that we consider quintessentially human, like thinking, speaking and creating works of art. Looked at from this perspective, our mind is a set of operations carried out by our brain. The same principle of unity applies to mental disorders.

In years to come, this increased understanding of the physical workings of our brain will provide us with important insight into brain disorders, whether psychiatric or neurological. But if we persevere, it will do even more: it will give us new insights into who we are as human beings.

“The New Science of Mind” by Eric R. Kandel in The New York Times on September 6, 2013.  

Eric R. Kandel, a professor at the Mortimer B. Zuckerman Mind Brain Behavior Institute at Columbia, a senior investigator at the Howard Hughes Medical Institute and a recipient of the 2000 Nobel Prize in Physiology or Medicine, is the author of “The Age of Insight: The Quest to Understand the Unconscious in Art, Mind and Brain, From Vienna 1900 to the Present.”

A team of University of California, Riverside researchers have developed a novel transparent skull implant that literally provides a “window to the brain”, which they hope will eventually open new treatment options for patients with life-threatening neurological disorders, such as brain cancer and traumatic brain injury.

The team’s implant is made of the same ceramic material currently used in hip implants and dental crowns, yttria-stabilized zirconia (YSZ). However, the key difference is that their material has been processed in a unique way to make it transparent.

Since YSZ has already proven itself to be well-tolerated by the body in other applications, the team’s advancement now allows use of YSZ as a permanent window through which doctors can aim laser-based treatments for the brain, importantly, without having to perform repeated craniectomies, which involve removing a portion of the skull to access the brain.

The work also dovetails with President Obama’s recently-announced BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative, which aims to revolutionize the understanding of the human mind and uncover new ways to treat, prevent, and cure brain disorders. The team envisions potential for their YSZ windows to facilitate the clinical translation of promising brain imaging and neuromodulation technologies being developed under this initiative.

“This is a case of a science fiction sounding idea becoming science fact, with strong potential for positive impact on patients,” said Guilermo Aguilar, a professor of mechanical engineering at UC Riverside’s Bourns College of Engineering (BCOE).

Aguilar is part of 10-person team, comprised of faculty, graduate students and researchers from UC Riverside’s Bourns College of Engineering and School of Medicine, who recently published a paper “Transparent Nanocrystalline Yttria-Stabilized-Zirconia Calvarium Prosthesis” about their findings online in the journal Nanomedicine: Nanotechnology, Biology and Medicine.  

Laser-based treatments have shown significant promise for many brain disorders. However, realization of this promise has been constrained by the need for performing a craniectomy to access the brain since most medical lasers are unable to penetrate the skull. The transparent YSZ implants developed by the UC Riverside team address this issue by providing a permanently implanted view port through the skull.  

“This is a crucial first step towards an innovative new concept that would provide a clinically-viable means for optically accessing the brain, on-demand, over large areas, and on a chronically-recurring basis, without need for repeated craniectomies,” said team member Dr. Devin Binder, a clinician and an associate professor of biomedical sciences at UC Riverside.

Although the team’s YSZ windows are not the first transparent skull implants to be reported, they are the first that could be conceivably used in humans, which is a crucial distinction. This is due to the inherent toughness of YSZ, which makes it far more resistant to shock and impact than the glass-based implants previously demonstrated by others. This not only enhances safety, but it may also reduce patient self-consciousness, since the reduced vulnerability of the implant could minimize the need for conspicuous protective headgear.

In addition to Aguilar and Binder, authors of the paper are: Yasaman Damestani, a Ph.D. student working with Aguilar; B. Hyde Park, an assistant professor of bioengineering; Carissa L. Reynolds, a Ph.D. student working with Park; Javier E. Garay, an associate professor of mechanical engineering; Yasuhiro Kodera, a project scientist who works in Garay’s lab; Masaru P. Rao, an assistant professor of mechanical engineering; Jenny Szu, a lab technician in Binder’s lab; and Mike S. Hsu, a staff research associate in Binder’s lab.

This research was supported, in part, by the UC Riverside Chancellor’s Strategic Research Initiative.

“Creating a 'Window to the Brain',” by Sean Nelson for UCR Today on September 3, 2013

Women have long been thought to have much higher rates of depression than men, but when alternative and traditional symptoms of depression are considered, these sex disparities disappear, new research shows.

"The sex differences framework is rooted in the idea that the construct of depression is the same in men and women and seeks to investigate sex differences in a range of related variables, including symptoms," investigators led by Lisa A. Martin, PhD, from the University of Michigan, Dearborn, write.

"Although this has been a popular approach to date, it is often critiqued for relying on oppositional binaries that understand 'male depression' only as it is contrasted with 'female depression,' which fails to acknowledge the heterogeneity that exists within these groups."

The study was published online August 28 in JAMA Psychiatry.

More Anger, Aggression in Men

The aim of the study was to explore whether sex disparities in depression rates disappear when other symptoms besides conventional depression symptoms are considered.

The researchers used data from the National Comorbidity Survey Replication (NCS-R), a nationally representative survey of the incidence and prevalence of mental disorders among English-speaking adults in the United States.

The survey included 3310 women and 2382 men. Their mean age was 45.2 years, 73.4% were non-Hispanic white, and 51.6% had some education beyond high school. The mean annual household income was $59,575. The mean income for men was $63,365, and for women, it was $49,327.

The researchers developed 2 scales. The first, the Male Symptoms Scale (MSS), included alternative male-type symptoms of depression, including irritability, anger attacks/aggression, sleep disturbance, alcohol or drug abuse, risk-taking behavior, hyperactivity, stress, and loss of interest in pleasurable activities.

The second scale, the Gender Inclusive Depression Scale (GIDS), included all of the MSS symptoms, plus 7 traditional symptoms of depression, including sad/depressed mood, loss of vitality, tiredness, ambivalence, anxiety/uneasiness, and complaintiveness or feeling pathetic.

Using the MSS scale that included alternative, male-type symptoms of depression, the researchers found a higher prevalence of depression in men (26.3%) than in women (21.9%) (P = .007).

The researchers also found that men reported significantly higher rates of anger attacks/aggression, substance abuse, and risk-taking behavior compared with women.

More Stress, Irritability in Women

Women, on the other hand, reported significantly greater rates of stress, irritability, sleep problems, and loss of interest in things they usually enjoyed, such as work, hobbies, and personal relationships.

No sex difference in the prevalence of depression as assessed by the GIDS that included alternative and traditional depression symptoms was found. According to that scale, 30.6% of men and 33.3% of women met criteria for depression.

In terms of severity of depression, the researchers found that 63.2% of men and 62.0% of women fell into the mild category, meaning that they had 1 to 4 symptoms; 28.3% of men and 28.9% of women fell into the moderate category, with 5 to 9 symptoms; and 8.5% of men and 9.1% of women fell into the severe category, with 10 to 15 symptoms. No significant sex differences were demonstrated at any severity level, they report.

"These results suggest that relying only on men's disclosure of traditional symptoms could lead to an underdiagnosis of depression in men and that clinicians should consider other clues when assessing depression in men," the authors write.

They also point out that "despite the significant findings reported in this study, there are noteworthy limitations."

One limitation was that the study did not include symptoms among men such as overworking, overexercising, changing their sexual behavior, or gambling. Also, items that assessed taking chances or reckless behavior were not linked to an emotional condition. Future studies should include items that assess the excluded behaviors, the authors suggest.

They conclude that the results of their study have the potential to bring "significant advances to the field in terms of the perception and measurement of depression. These findings could lead to important changes in the way depression is conceptualized and measured."

By Fran Lowry for Medscape on Aug 29, 2013

‘Migraine Linked to Structural Brain Changes’ by Pauline Anderson for Medscape on Aug 28, 2013:

A new literature review confirms that compared with patients without migraine, those with migraine have more white matter abnormalitiies (WMAs), infarct-like lesions (ILLs), and volumetric changes in gray and white matter regions of the brain, although the cllnical and functional significance of these lesions is still uncertain.

The analysis showed that the association between migraine and structural changes in the brain is stronger among those who experience migraine with aura.

The results challenge the widely accepted notion that migraine is a benign primary headache with no long-term consequences or sequelae for the brain.

"Our study, based on a systematic review and meta-analysis, suggests the opposite: that this primary headache disorder may permanently change the brain structure," said author Sait Ashina, MD, headache program director, Beth Israel Medical Center, and assistant professor, neurology and anesthesiology, Albert Einstein College of Medicine, New York, New York.

However, Dr. Ashina cautioned that not all the evidence is in yet and that prospective longitudinal studies are needed to confirm the influence of migraine on brain structure. 

The study was published online August 28 more …

Levels of calcitonin gene-related peptide (CGRP), a neurotransmitter that causes vasodilation, are elevated in the peripheral blood of women with chronic migraine (CM), and to a lesser extent in women with episodic migraine, compared with levels in healthy controls without a history of headache, new research reveals.

The study shows, for the first time, increased CGRP levels in patients with CM outside migraine attacks and in the absence of medication for symptoms.

The results suggest that CGRP levels could be used as a biomarker for permanent trigeminovascular activation and therefore help diagnose chronic migraine. Until now, the diagnosis of primary headache has been based only on clinical grounds.

"It's important to have biomarkers, not only to avoid misdiagnoses but also for treatment follow-up," said study author Julio Pascual, MD, PhD, director, Neuroscience Department, and professor, neurology, University Hospital Central de Asturias, Oviedo, Spain.

"Can you imagine diagnosing and treating diabetes only on clinical grounds? That's what we do now in primary headaches. Chronic migraine is the most frequent type of almost daily headache, and it's very disabling."

The study was published online August 23 in Neurology.

Throbbing Pain

It is well established that during a migraine attack, trigeminal activation leads to release of CGRP from presynaptic nerve terminals. This facilitates a peripheral inflammatory and vasodilatory response and causes activation of neurons involved in pain transmission, the authors note. This explains the typically throbbing pain experienced by people suffering a migraine.

CM is defined at least 15 headache days per month for at least 3 months. Fewer than 15 headache days per month is considered episodic migraine (EM).

Using the right antecubital vein, researchers obtained blood samples from participants who were not experiencing moderate or severe pain and had not taken medication for symptoms in the previous 24 hours. For ethical reasons, participants could continue daily preventive medications, and most with migraine were taking these agents. The investigators determined CGRP levels using a commercial enzyme-linked immunosorbent assay kit.

The study included 103 women with CM (mean age, 43.1 years), 31 matched healthy women with no headache history (mean age, 38.6 years), 43 women with EM (mean age, 44.4 years), and 14 patients with episodic cluster headache (including 13 men; mean age, 45.4 years) matched for age in a pain-free period.

Study participants underwent a general physical and neurologic examination. Those with EM and CM had at least a normal neuroimaging examination.

The analysis showed that CGRP levels were significantly higher in women with CM (74.90 pg/mL) than in control women (33.74 mg/mL; P < .001), women with EM (46.37 pg/mL; P < .001 vs CM and P < .005 vs controls) and to patients with episodic cluster headache (45.87 pg/mL).

"Increased peripheral CGRP levels should be interpreted as a distant sign of activation of the trigeminovascular system; because its molecule is so large, CGRP cannot pass the blood-brain barrier," said the authors.

Thresholds of 43.45 and 58.22 pg/mL optimize the sensitivity and specificity to differentiate patients with CM from healthy controls and patients with EM, respectively, according to the authors.

Migraine With Aura

A total of 46 women with CM had a history of migraine with aura attacks. CGRP levels were significantly higher in these women than in those who had never experienced an aura. However, only 4 patients experienced at least 1 aura per month.

According to the authors, there are several potential explanations for this finding. It could, for example, support the proposal that the pathophysiologic mechanism of the aura, the cortical spreading depression phenomenon, is enough to activate sensory nerve terminals around pial blood vessels.

Among women with EM, CGRP was not significantly elevated in the 21 women with aura compared with the 22 with no aura antecedents.

Among the women with CM, CGRP levels were not significantly different in patients meeting criteria for analgesic overuse. "Even considering that all of the women in our study with CM meeting overuse criteria had tried formal withdrawal of symptomatic medications at least once and for 2 months without success, these results are a further proof that both subtypes of CM, with and without analgesic overuse, would share the same pathophysiologic substrate," the authors write.

Other variables, such as age, depression, fibromyalgia, vascular risk factors, history of triptan use, and type of preventive treatment, also did not influence CGRP levels.

The fact that patients were taking preventive medications could be considered a limitation of the study but could also make the results more relevant because, as the authors point out, these drugs could reduce trigeminovascular system activation, resulting in a decrease in CGRP release.

Although the new study had other potential limitations, such as the use of a select headache clinic population, "it seems that interictal CGRP levels are somewhat specific and sensitive for CM in the context of a patient with daily or almost daily headaches and a history of migraine, which could be of great help on sharpening the diagnosis of the primary headache disorders and supports the proposal of a key role of CGRP of sensitization of pain circuits leading to CM," the authors concluded.

Using CGRP as a biomarker for CM may not be that far off from clinical practice, if the current results are confirmed in other studies using this neuropeptide, perhaps together with other pain-producing peptides, said Dr. Pascual. Such studies, he said, would not be difficult to carry out.

"My prediction is that clinical trials in chronic migraine that include the follow-up of CGRP levels will begin soon after publication of our study," he said.

And, he said, it won't be long before hospitals will start using CGRP levels to routinely follow patients with CM because this testing is neither very expensive nor difficult to perform.

Monitor Status

In an accompanying article, Stephen D. Silberstein, MD, Jefferson Headache Center, Jefferson Center for Neuroscience, Philadelphia, Pennsylvania, and Lars Edvinsson, MD, Internal Medicine, Lund University, Sweden, agreed the study demonstrates that peripheral CGRP levels may be a biomarker for CM.

Physicians could use CGRP levels outside migraine attacks, and in the absence of medication for symptoms, to monitor a patent's status and response to preventive treatment, they write.

"Future work on the role of CGRP and its receptor in CNS and intracranial structures will be very interesting," they write. "In particular, we look forward to learning more about the effects of small-molecule CGRP antagonists and antibodies toward CGRP and the CGRP receptor on CGRP levels and clinical outcome."

They noted that until now, CGRP elevations in plasma have not been reproduced in all studies but that technical problems have at times hampered the proper measurements of this neuropeptide.

Dr. Pascual served on the scientific advisory boards of Allergen and MSD. 

“Neuropeptide May Be Biomarker for Chronic Migraine” by Pauline Anderson for Medscape on Aug 27, 2013

Make sure that patients understand their condition, take their medicine and see their primary care doctors so they don’t wind up back in the hospital. Common sense things, right?  Only until the Affordable Care Act threatened hospitals with the loss of money, however, did such coordination of care start to become common.

Four out of five hospital in Florida still “re-admit” too many patients, but the law is pushing them to improve care.  It is a less-publicized but crucial component of the law that Republicans have voted 40 times to repeal, delay or defund.  New Gingrich, who railed against the law as a presidential candidate, blasted fellow Republicans Wednesday for not having a viable alternative to it.

Make sure that patients understand their condition, take their medicine and see their primary care doctors so they don’t wind up back in the hospital.  Common sense things, right?  Only until the Affordable Care Act threatened hospitals ith the loss of money, however, did such coordination of care start to become common.

Speaking at the Republican National Committee’s summer meeting, Mr. Dingrich said, “I will bet you, for most of you, you go home in the next two weeks when your members of Congress are home, and you look them in the eye and you say, ‘What is your positive replacement for Obamacare?’ They will have zero answer.”

Indeed.  The law is hardly perfect.  But even though it won’t take full effect until 2015, it is already having a positive impact on health care quality.  The law rewards doctors and hospitals for improving care to Medicare patients and penalizes them when patients get sicker as a result of poor coordination and follow-up.  One measure is excessive hospital readmissions.

As the Post’s Stacey Singer reported, 80 percent of Florida hospitals will be penalized by Medicare next year for above-average readmission rates, including nine out of 13 Palm Beach County hospitals.  The penalties are forcing hospitals to make quality of care, not quantity of care, the priority.

Jupiter Medical Center, a nonprofit that recently held a summit on improving post-release coordination of care, is one of the four hospitals that will not see a penalty.  The others include Bethesda Health in Boynton Beach, which owns Bethesda Hospital East and Bethesda Hospital West, and Boca Raton Regional, all of which also are independent nonprofits.  Tenet Healthcare’s Good Samaritan Medical Center, a for-profit that received a .02 percent penalty for 2013, improved enough to become the fourth.

This is the second year that Boca Raton Regional, which sees a large number of Medicare patients, has escaped penalties.  Chief Medical Officer Dr. Charles Posternack said most patients are highly educated and affluent, which makes transition of care less challenging than for other hospitals.  He said educating patient about their disease and medications is key, along with ensuring follow-up care.

“It’s the culture of the hospital,” Dr. Posternack said.  “It’s important not just to get them to have to come back in again because you just didn’t do a good job.”  Is this what Republican critics of the Affordable Care Act want to repeal, delay and defund?

“The good: Better hospitals” by Rhonda Swan in The Palm Beach Post on August 16, 2013

On Thursday, U.S. Department of Health and Human Services Secretary Kathleen Sebelius held a media call and press conference in Tampa to announce new Affordable Care Act grants to help consumers enroll in insurance plans.  There was no such announcement, however, when the administration decided months ago to delay for some insurers the limit on out-of-pocket expenses the can impose on insurers.

There is a case to be made for the administration latest delay of a key provision in the law.  But because the delay doesn’t make the law look good, the administration buried the announcement online in a February FA Q put out by HHS and the Labor and Treasury departments.

The health care law is complex, and implementing its numerous provisions will be a challenge for the administration.  But it’s not as if the country hasn’t been here before, and recently.  Consider the rollout of Medicare Part D, the prescription drug program, in 2005.

“Although the officials implementing Part D encountered significant technical, educational, and coordination difficulties at first, eight years later … the public generally views the program as a success,” says a June study by the Center on Health Insurance Reforms.  The center looked at Part D for lessons on implementing the Affordable Care Act.  “While flaws remain,” the Part D study said, “a program born amidst partisan controversy and launched with considerable wariness has emerged to become a core part of Medicare.”

Such partisan controversy makes the Obama administration wary of communicating anything about the health care law that could be deemed negative.  Last month, the administration used a blog post to announce a one-year delay of the employer mandate.  Though Kaiser Health News reported the new delay in April, opponents of the law didn’t pounce on the issue until the New York Times reported it this week.

Beginning in 2014, the law caps annual out-of-pocket costs at $6,350 for individuals and $12,500 for families.  The provision will not be enforced for some employer insurance plans, though, until 2015.

Those employers have separate benefit managers for different parts of their coverage, such as medical care and drugs.  Their technical systems can’t communicate with one another yet.  Out-of-pocket limits will be enforced for all plans on the insurance exchanges, plans with only one administrator, and all new plans.

It’s not the disaster opponents make it out to be.  But it is a setback for consumers with chronic ailments and high drug costs.  The administration should just say that.

“The bad: Too much secrecy” by Rhonda Swan in The Palm Beach Post on August 16, 2013

Until now, the Affordable Care Act was a massive piece of government bureaucracy that many American knew little about or didn’t particularly like.

On Thursday, the Obama administration named the organizations, including one in Palm Beach County, that will become the face of the controversial law.

More than 100 organizations will spend $67 million to hire workers who will go out into communities and enroll people in health insurance under the law beginning in October.

The funding is particularly crucial in Florida, where the state is not spending any additional money to get the word out about the new law or to try to enroll some of its 3.5 million uninsured residents.

“People have lots of trouble understanding what the law is.  The navigators will be that link,” said Leah Barber-Heinz, director of Florida CHAIN, a healthcare advocacy group.

“We know that 78 percent of people are unfamiliar with what the marketplace is, let alone how to shop and compare and contrast the options that will soon be there for families.”

The hundreds of “navigators” hired could shape how the law is perceived and bend the cost curve of health insurance.  If they can enroll a large enough segment of the young and healthy, the cost of health care for others will go down.

The Affordable Care Act prevents insurers from denying coverage to people who are already sick.  If large numbers of older, sick Americans sign up without healthy people to counterbalance them, health insurance premiums could skyrocket.

The Legal Aid Society of Palm Beach is one of eight organizations receiving $7.8 million to reach out in Florida.  The society’s grant of $446,783 will allow it to target consumers in Palm Beach, Martin, Okeechobee, and Hendry counties.

The organization’s focus will include “urban and rural communities that are racially, ethnically, linguistically, culturally and socioeconomically diverse.”  It’s audience is 270,000 people in those counties who have no health insurance and who are under the Medicare eligibility age of 65.

“This was something that was near and dear to our hearts,” said Robert Bertisch, the society’s executive director.  “We see what happens to people when they don’t have coverage.  Most of our clients who need help with their bankruptcy, one of the reasons (they file) is they have medical debts they just cannot pay for.”

The organization already works with clinics to identify patient who may have a legal issue, such as mold in an apartment that is causing a child’s asthma.

The group proposes to: hire five navigators; participate in 60 community events across four counties; enroll 3,000 people; produce five multilingual Public Service Announcements.

Health and Human Services Secretary Kathleen Sebelius announced the grant awards on a conference call during a trip to the University of South Florida’s College of Public Health in Tampa.

The agency is prepared to enroll millions of American – some for the first time – in less than two months, she said.

“We’re on schedule with providing consumers with tools online, on the phone and in person, to get the coverage they need,” she said.  “And we’ll be ready October 1.”

Through the website healthcare.gov, people can enroll on their own.  They can call a help line for phone assistance.  That’s where the navigators come in. 

The state’s biggest counseling push will come from the University of South Florida program, called Florida Covering Kids & Families.  The nonprofit received $4.2 million.  It will work with up to 10 partners to help consumers and small businesses enroll.  It will also have educational activities to promote the insurance exchange, also known as a marketplace, where consumers can sign up for insurance online.

Other organizations receiving grants in Florida include the Epilepsy Foundation of Florida; Advanced Patient Advocacy, which works in 21 states to help educate and enroll uninsured consumers; the Pinellas County commission; the National Hispanic Council on Aging; and Mental Health America; which will target people with behavioral disorders.

This counselors hired by these organizations will spend 20 to 30 hours in training, be required to pass a test and be expected to follow rigorous privacy and data standards.

Florida Attorney General Pam Bondi was one of 13 attorneys general who sent a letter Wednesday saying HHS “failed to adequately protect the privacy” of American who use counseling services associated with the health care law.  They argued that agency rules do not require background checks or list any disqualifying criminal acts that might prevent a counselor from being chosen.

“We are absolutely focused on privacy and security standards at the department,” said Chiquita Brooks-LaSure, deputy director of policy and regulations at HHS’ Center for Consumer Information and Insurance Oversight.

Organization will begin hiring counselors immediately.  Training is scheduled for later this month.

"‘Navigators’ to help state residents get Obamacare" by Laura Green in The Palm Beach County Post on August 16, 2013

Economists specialize in pointing out unpleasant trade-offs — a skill that is on full display in the health care debate.

We want patients to receive the best care available. We also want consumers to pay less. And we don’t want to bankrupt the government or private insurers. Something must give.

The debate centers on how to make these trade-offs, and who gets to make them. The stakes are high, and the choices are at times unseemly. No matter how necessary, putting human suffering into dollars and cents is not attractive work. It’s no surprise, then, that the conversation is so heated.

What is a surprise is that amid these complex issues, one policy sidesteps these trade-offs. A few drugs — such as beta-blockers, statins and glycogen control medications — have proved very effective at managing hypertension, heart disease, diabetes and strokes. Most insurance plans charge something for them. Why not make drugs like these free? Not for everyone, but just the groups for whom they are provably effective.

In traditional economics, such a policy creates waste. The basic principle is moral hazard: consumers overuse goods that are subsidized. This is why people fly in business class when they’re on an expense account but in economy when it’s on their own dime.

In health care, a doctor or patient might order an extra test casually, just because it’s free. This is inefficiency at its worst: from money spent on costly procedures to tests and medicines that provide little medical benefit, some actions are undertaken only because someone else picks up the check. To discourage this waste, insurance plans charge co-payments. The logic is simple: if patients face costs, they will think more carefully about the benefits.

But people don’t always follow a cost-benefit logic. Consider a patient recovering from a heart attack. A small cocktail of drugs may cost a trivial amount — say, $5 — yet it reduces the risk of subsequent heart disease mortality by as much as 80 percent. That’s a good deal, but as many as 50 percent of people fail to take these medications regularly.

The problem is basic human psychology.  Heart disease is silent, with few noticeable symptoms. You feel fine most of the time, so it’s all too easy to justify skipping the statin.

The problem here is the exact opposite of moral hazard. People are not overusing ineffective drugs; they are underusing highly effective ones. This is a quandary that two colleagues — Katherine Baicker, a professor of health economics at Harvard, and Josh Schwartzstein, a professor of economics at Dartmouth — and I call “behavioral hazard.”

We've found that co-payments do not resolve behavioral hazard. They make it worse. They reduce the use of a drug that is already underused.

A recent experiment by a team led by Niteesh Choudhry, a professor of medicine at Harvard, quantifies the problem. The experiment involved nearly 6,000 patients who had just suffered a heart attack, and were prescribed drugs known to reduce the chance of another one — statins, beta-blockers, angiotensin-converting-enzyme inhibitors or angiotensin-receptor blockers. Half had their co-pays for these drugs waived; the other half paid the usual fee.

As expected, more people in the zero co-pay group took the drugs, and their health improved. Those in the zero co-pay group were 31 percent less likely to have a stroke, 11 percent less likely to have another major “vascular episode” and 16 percent less likely to have a myocardial infarction or unstable angina. None of these benefits came at a net monetary cost. The insurers did not spend more in total. By some measures, they spent less.

Behavioral hazard affects all of the drugs listed above. They are all highly effective, and yet adherence to taking them is a problem. This is a major financial issue. The New England Healthcare Institute has estimated that solving non-adherence could save $290 billion a year, or 13 percent of total annual medical spending in the United States. A number this large is surely open to quibbling, but divide it by 10 and it is still a large figure.

I’m not proposing to make all health care free, or arguing for a return to so-called Cadillac health plans. Moral hazard is all too real for many treatments, and in some cases, behavioral hazard reinforces it. Just as people under-respond to inconspicuous symptoms, they can also over-respond to highly noticeable ones. People may seek too much care for back pain, for example, resorting to ineffective or possibly even harmful treatments. Behavioral hazard suggests that we need even larger co-payments for these overused drugs.

My proposal is targeted: Take drugs that are shown to be of very high benefit to some people, and make those drugs free for them.

It’s a simple policy change, and it isn’t meant as a complete solution.

First, researchers like A. Mark Fendrick, a professor of internal medicine at the University of Michigan, and Michael Chernew, now a professor of health care policy at Harvard, argue eloquently for what they call “value based” health insurance. All co-pays should depend on measured medical value; high co-pays should be reserved for drugs and medical services that have little proven value.

Second, some people will neglect to take their medications even if co-pays are zero. This proved true even in the Choudhry study.

Fully solving this problem requires more creativity.  GlowCaps, for example, are high-tech tops for pill bottles. They beep and text you if you forget to take your medication. In another approach, Kevin Volpp, a professor of medicine and health care management at the University of Pennsylvania, and his colleagues use lotteries, giving people a chance to win only if they take their medications.

Finally, some will suggest that focusing on drug adherence is like closing the barn door. Why not focus instead on the behaviors — eating unhealthy foods or shunning exercise — that created the conditions we must now treat with drugs?

Each of these points has some merit. But they fail the “perfect as the enemy of the good” test. Sure, we should do more. But meanwhile, why continue to charge the same co-pay for statins and beta-blockers as we do for Viagra? At the very least, we need to experiment more with this policy.

“When a Co-Pay Gets in the Way of Health” by Senhill Mullainathan in The New York Times on August 11, 2013.  Mullainathan is a professor of economics at Harvard.

An Increase in Robotic Surgery AERs, the FDA Survey

Robotic technology has gained popularity in various surgical specialties, including urology, gynecology, thoracic surgery, general surgery, and head and neck surgery. The da Vinci® Surgical System (Intuitive Surgical®; Sunnyvale, California) is the only FDA-approved robotic system on the market. The system has now been installed at more than 2000 hospitals around the world, according to Intuitive Surgical. Between 2011 and 2012, the number of associated adverse event reports (AERs) increased by 34%, from 211 to 282.^[1] This has prompted the FDA to survey robotics-using surgeons about their experiences. During that period, the number of procedures performed with the da Vinci system increased by 26%, from 292,000 to 367,000.

AERs With Robotics: Any Worse Than After Laparoscopy?

The robotic platform is only 8 years old, so any surgeon who has used the device has, at most, only 8 years of experience, and so the rate of AERs in general still is likely to be high.^[2] Medscape interviewed Joseph Colella, MD, founder of the Clinical Robotic Surgery Association, who believes that curves of adoption and adverse events that occur with robotics, and that occurred with laparoscopic surgery, are very similar, if not almost identical. As an example, he said, "One of the more commonly reported errors with robotics is inappropriate arcing of a coagulation device, where it injures a piece of intestine. Those same events happened and still happen with laparoscopy." To date, studies comparing laparoscopy and robotic procedures are of poor quality and suffer from significant heterogeneity and control bias.^[3]

What About Machine Errors?

Recent studies^[4,5] and lawsuits involving microcracks in the insulation, which may cause burning, have triggered questions about the safety of robotic surgery, which subsequently has been covered in the popular media.^[6] Dr. Colella believes that machine errors are rare. "In my experience, I have never had the robot malfunction in any way." A 2008 review looked at the FDA Manufacturer and User Facility Device Experience (MAUDE) database, a valuable source of information on adverse outcomes associated with devices.^[7] It reported an estimated rate of device malfunctions of 0.38%, and only a small percentage of these were associated with patient injury.^[8]

The robotic approach provides surgeons with multiple advantages compared with open procedures and other minimally invasive approached, notably a 3-dimensional perspective and improved dexterity and precision.^[9] Dr. Colella described the advantages for the patient.  “As a potential patient, stop for a moment and put on the common-sense hat.  Your surgeon tells you that he can see 100% better in 3 dimensions, that he can sew better and probably within 1-2 years he will be able to do every procedure though 1 incision.  You can imagine that the sky is the limit in employing robotic surgery.  It’s an enabling technology.  I firmly believe that we are finding new and beneficial applications almost on a monthly basis.

There are also a number of disadvantages.^[9]  Dr. Colella mentioned, “The robotic visual field is somewhat smaller that the laparoscopic visual field.  However, you quickly adapt and know the limits of your vision or the lack of them.”  Training and experience typically resolve this problem, and surgeons learn to compensate for loss of tactile and force feedback.  For surgeons in training, however, the latter challenge increases the risk of rupturing sutures during knotting.

Is Insufficient Training a Serious Problem With Robotic Surgery?

Intuitive Surgical is currently facing various lawsuits involving improperly trained surgeons.^[10] In a Medscape interview, J. Kellogg Parsons, MD, Associate Professor of Surgery, Department of Urology, Moores Cancer Center, University of California, San Diego, pointed out that "there is no standardized process for credentialing, teaching, proctoring, or obtaining hospital privileges for robotic-assisted surgery." Both the Institute of Medicine and the FDA have recognized that the process by which new devices enter into practice needs to be revised.^[11,12]

Statement From James T. Breeden, MD, President, ACOG

In March 2013, James T. Breeden, MD, President of the American Congress of Obstetrics and Gynecology (ACOG), issued a statement that recommended against using robotic devices in routine gynecologic procedures.^[13] A 2013 study in JAMA reported that the percentage of robotically assisted hysterectomies increased from 0.5% in 2007 to 9.5% in 2010.^[14] Three years after the first robotically assisted hysterectomies were performed, the approach accounted for 22.4% of all hysterectomies where robotic surgery was available. Studies suggest that robotic and laparoscopic hysterectomy have similar morbidity profiles, but the use of robotics substantially increases costs.^[9,15] In the JAMA study, costs associated with robotically assisted hysterectomy were $2189 more per case than for laparoscopic hysterectomy.

Robotic Surgery for Hysterectomy

In the ACOG statement, Dr. Breeden said, "Patients should be advised that robotic hysterectomy is best used for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated." Some centers have reported shortened length of stay and reduced pain, operative time, and blood loss with robotic compared with nonrobotic hysterectomies, as well as fewer complications, but larger studies are needed to confirm its value compared to other minimally invasive procedures.^[15-17]

Robotic Surgery in Bariatrics

Robotic surgery is showing promise in complex bariatric cases, including in the superobese.^[18-20] Dr. Colella reported that the bleeding rate approaches zero, the major complication rate is less than 0.3%, and there have been no reported deaths. Stricture rates are substantially reduced and the procedure requires fewer staples than does laparoscopy. Dr. Colella added, "Robotics have lessened the need for pain medication, which allows much quicker gastrointestinal recovery, which, in turn, reduces the incidences of pneumonia and aspirations. It will be a tremendous game changer when you can do robotic gastric bypass with a single 15-mm incision in a 600-lb patient, who goes home the next day." Robotically assisted revision can be done safely but has a high postoperative complication rate.^[21]

Robotic Surgery for Prostatectomy

The European Association of Urology (EAU) has issued guidelines on robotic and single-site surgery in urology,^[22] which conclude: "Robot-assisted urologic surgery is an emerging and safe technology for most urologic operations." The evidence was best for prostatectomy. Nonetheless, the guideline authors also note that the evidence to support EAU's conclusions was generally poor and based on expert consensus. Even with prostatectomy, studies are not showing better long-term effects on incontinence and erectile dysfunction than with open prostatectomies. However, perioperative benefits were generally confirmed.^[23]

Other Procedures

Some studies have found robotic surgeries to be beneficial for specific complex procedures, including those for gastric cancer^[24] and transoral surgeries.^[25-27] A study on gastrectomy, however, found higher rates of anastomotic leaks in both robotic and laparoscopic surgery compared with the open procedure.^[28] It is still unclear whether robotic surgery has a superior advantage in most general surgeries. In a recent analysis, the robotic approach appeared to be cost-effective and as safe as nonrobotic surgery, except in cholecystectomy and esophagogastric procedures.^[29] Robotic surgery is being used in many urologic procedures in addition to prostatectomy,^[30] but, as with other robotic procedures, even with its advantages cost remains an issue.^[31,32]

Cost and Overmarketing: The Elephants in the Room

The major issue in the use of robotics is the price. The machines themselves cost between $1.5 and $2.2 million, and service contracts run from $160,000 to $170,000 per year. Disposable instruments range from $600 to $1000, and each procedure can use 3-8 instruments. It is not yet known whether costs will be recouped downstream. An analysis published in March reported that da Vinci surgeries add incremental costs of 20% per procedure, which are absorbed by the hospitals.^[3] There is also some indication that hospitals overmarket their robotic capabilities. In a 2011 study, investigators reported that 41% of hospital Websites described their capabilities; clinical superiority was claimed on 86% of these sites, and none mentioned risks.^[33]

Competitors and Future Robotics

At this time, there is no competitor to the da Vinci robotic system, although systems are in development in Canada, Europe, and Asia. Dr. Colella said, "Other technologies are attempting to enter that space, but right now the barriers to entry are very significant. Of course, it's inevitable that eventually there will be competition."

References ...

“Robotic Surgery: Too Much, Too Soon?” by Carol Packham & Steven Schwaitzberg, M.D., for MedScape on August 8, 2013