‘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

FAIR Health has been named as a Quality Measurement and Data Analytics Award finalist in the 2013 Awards for Best Practices in Health Care Consumer Engagement and Protection by  URAC, a leading healthcare accreditation organization.  FAIR Health’s program, Empowering Consumers to Understand Healthcare Reimbursement and Plan and Estimate Medical and Dental Expenses, is one of six finalists in this category, selected from entries across the nation by a distinguished panel of judges, and will be honored during URAC’s 2013 Quality Summit, September 30 — October 1, 2013, at the Capital Hilton in Washington, D.C.

“Advanced approaches to quality measurement and data analytics hold the key for better patient care and quality, and greater value for every healthcare dollar spent,” said Kylanne Green, President and CEO of URAC.  “URAC is honored to recognize organizations like FAIR Health that are demonstrating best practices and shining a light on new ways to make data pay dividends for patients and the healthcare system at large.”

FAIR Health’s program, Empowering Consumers to Understand Healthcare Reimbursement and Plan and Estimate Medical and Dental Expenses, is based on FAIR Health’s  award-winning free consumer website, www.fairhealthconsumer.org, and companion mobile app that offer decision-support tools designed to enable consumers to estimate and plan their medical and dental expenditures. 

The tools on FAIR Health’s consumer website and mobile app offer cost estimates for specific procedures and services based on charges for the geographic area where the service is provided; these tools are powered by FAIR Health’s proprietary database constituting the most comprehensive set of private healthcare claims in the nation with over 17 billion billed medical and dental procedures performed since 2002.  In addition to FAIR Health’s consumer tools, the website and mobile app also offer clear, unbiased educational articles, videos and a glossary of insurance terms to help consumers understand the healthcare insurance reimbursement system and provide context for the cost estimates they receive.  A Spanish-language version of the consumer site at consumidor.fairhealth.org provides the same tools and educational resources for Spanish-speaking consumers. 

“FAIR Health is privileged to be part of the national dialogue on consumer engagement and protection in healthcare,” said FAIR Health President Robin Gelburd.  “Our recognition by URAC is a tremendous honor; it highlights the importance of FAIR Health’s mission to bring greater transparency to healthcare costs for all healthcare stakeholders.  As the healthcare sector continues to evolve, we are proud to offer robust tools that better enable consumers to make educated healthcare decisions and manage healthcare expenses based on independent, reliable data.”

URAC intends to present Gold, Silver, and Bronze awards in the Quality Measurement and Data Analytics category, to be announced at the 2013 Quality Summit on October 1, 2013.  For complete conference details, go to https://www.urac.org/2013AnnualSummit/AnnualSummit.asp

“FAIR Health Named as Finalist in URAC 2013 Awards for Best Practices in Health Care Consumer Engagement and Protection,” press release via communications@fairhealth.org, August 8, 2013

Late last week, the Food and Drug Administration gave its stamp of approval to the marketing of the world's first device designed to help diagnose ADHD - a disorder that plagues some 6.4 million children - by scanning a child's brain waves. 

And, get this: the company behind the breakthrough was not a major pharmaceutical company or biomedical manufacturing firm.

In fact, it was a 10-person start-up in Augusta, Georgia, called Neba Health, a company so under-the-radar that Google hasn't even indexed its website. 

The Backstory

According to Neba's president, Howard Merry, the company was founded in 2006, and has had the same exact team over the last seven years--a pretty amazing feat when you consider the turnover rate for most start-ups. The journey, however, was far from easy. 

"There were some days that I would come to work, and the task before us was so herculean," says Merry. "We were such a small group with limited resources that, to be frank about it, I would despair."

Merry won't say how much capital the company has raised, but says several "high net worth individuals" made angel investments to keep the company afloat. 

Nicknamed the NEBA (its full name is the Neuropsychiatric Interpretive Electroencephalograph Assessment Aid), the device looks like a small cap that gets affixed to a child's head, not altogether unlike the electrodes put on your chest during a trip to the doctor's office. The cap then measures electrical activity in the front of the brain--particularly, the ratio of "fast waves" to "slow waves." 

According to Merry, a lot of research shows that there are implications for kids who have ADHD that can be observed directly in these brain waves.  "We're basically processing these brain waves for a particular biomarker," he says. 

Neba's clinical tests proved that a clinician could use NEBA to improve accuracy by about 44 percent - that's an increase from 61 percent to 88 percent.

The Long Road to the FDA

Neba's discussions with the FDA began in 2006. Then, the clinical trial began in 2007. Trials ran through 2008 to 2009, and the FDA submission was in 2010. Then, there were about two years of questions from the FDA. 

“The strategy was to meet with the FDA, get as clear guidance as we could, and do exactly what they told us they wanted," he says. "We went back to them so many times until they were sick of us. You don't get the benefit of the doubt that Merck would. You're unknown to the FDA. You can't just talk--you have to show."

Working with a third-party clinical testing group, Neba studied 275 children and adolescents ranging in age from 6 to 17 years old, all of whom exhibited signs of attention or behavioral concerns. As the FDA noted its own release this week, "the study results showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD, compared with doing the clinical assessment alone."

Now that the company has been granted approval to sell the device, Merry says he's targeting clinicians and hospitals as potential customers. 

The business model is fairly straightforward--it costs around $300 for parents to get their kids tested. Since no insurance company currently accepts a NEBA scan, a parent would enter the clinical and billing information with Neba directly, and Neba would then send that information to the clinician. The technician then runs the report, and Neba charges the patient once the data is uploaded. The whole process takes about an hour.

The Skepticism

The device is not without some controversy. Late last week, ABC News published a highly skeptical news story about Neba Health, quoting several psychiatric experts doubting the company's motives. 

"I don't know that this is going to help the situation at all," Rachel Klein, a professor of child and adolescent psychiatry at NYU Langone Medical Center told ABC. "I think it's going to make people spend money needlessly."

Merry said the article hurt--especially because he didn't have a chance to respond. But he also argues that the story was fundamentally misinformed. 

"While there are some upfront costs, NEBA is worth it because of the increase in accuracy it brings the clinician and the overall costs associated with misdiagnosis," Merry says. 

Merry and his team are focusing on the NEBA to help diagnose ADHD now, but there are other products in development--in particular, two geared towards diagnosing depression and dementia. 

Obviously, seven years is a long time, and Merry is thrilled to finally see results. But it was hardly an easy route to get there. 

"Of course, you have to have a profit motive, but at some point, that's not enough," he says. "You have to have another motive, something that's satisfying."

"It may sound like BS," he says, "But it's about helping the kids. 

“The Tiny Start-up Behind the Brain Wave Test for ADHD” by Eric Markowitz, July 25, 2013, at Inc. com

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A wiry weave of brainwave-reading electrodes designed to detect signs of attention deficit hyperactivity disorder is drawing skepticism from experts who say behavior trumps brain activity when diagnosing ADHD.

The device, dubbed NEBA for "Neuropsychiatric EEG-Based Assessment Aid," was approved by the U.S. Food and Drug Administration Monday to help confirm an ADHD diagnosis, a complex label borne by some 6.4 million U.S. kids. But critics say the gadget puts profits before patients.

"I don't know that this is going to help the situation at all," said Rachel Klein, a professor of child and adolescent psychiatry at NYU Langone Medical Center. "I think it's going to make people spend money needlessly."

During a 15-minute test, the NEBA system measures and compares two kinds of brainwaves through electrodes on the scalp. Studies have found that kids with ADHD tend to have different brainwave ratios than those without the disorder, but Klein said there's "nothing to suggest" the comparison works to diagnose individual children.

"When a child walks into the office, we already know there's a problem. The issue is whether it's ADHD or something else," she said, noting that learning disabilities and certain mood disorders can share symptoms with ADHD. "We have no idea whether [the makers of NEBA] have been able to discriminate ADHD from something else."

NEBA Health, the Augusta, Ga., company that makes the device, has yet to publicly release data from a trial of 275 children on which the FDA based its approval.

"The study results showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD, compared with doing the clinical assessment alone," the FDA said in a statement, providing no further details about the comparison or the significance of the results.

Multiple calls to NEBA Health were not immediately returned.

An ADHD diagnosis is typically based on interviews with parents and teachers, though Klein admits not all general practitioners have time to take such a thorough history.

"There's no way someone can do the child justice in a 10- or 20-minute visit," she said, stressing that the diagnosis should be reserved for child psychiatrists and psychologists with the proper training. "You need a lot of background information, and you just don't have the time to get it in a regular medical practice."

Klein fears that busy GPs might buy into the NEBA system, which generates a readout of brainwave activity similar to the squiggly lines of a lie detector test, as a way to simplify a complex diagnosis.

"They can charge for it and it gives you a pseudo-scientific basis for the diagnosis – a piece of paper with little wiggles and you can say they're not the wiggles you expect," she said, adding that she hopes parents "understand the limitations of the test" and "realize they don't have to rely on commercial promotions."

The cost of the NEBA system and the proposed charge for the test has not been made public.

ADHD diagnoses are on the rise among U.S. children and teens, climbing steadily by 5 percent a year, according to data from the U.S. Centers for Disease Control and Prevention.In 2007, roughly 2.7 million U.S. kids were receiving medication for the disorder, according to a CDC survey of parents.

“Brainwave Test for ADHD: For Patients or Profit?” by Katie Moisse for Good Morning America, July 17, 2013