WHO Tells Govts to Reject Philip Morris-funded Smoking Foundation

WHO Tells Govts to Reject Philip Morris-funded Smoking Foundation

GENEVA (Reuters) – The World Health Organization told governments on Thursday not to get involved in a foundation funded by tobacco firm Philip Morris International to look at ways of reducing the harm from smoking.

The U.N. health body said there was a conflict of interest in a tobacco firm funding such research – drawing a sharp rebuke from the Foundation’s head who said his work was independent.

Philip Morris International said this month it wanted to help set up a body called the Foundation for a Smoke-Free World and planned to give it about $80 million a year for 12 years to keep it running.

The company did not immediately respond to a request for a comment on the WHO’s statement.

The U.N. body said on Thursday there were already proven techniques to tackle smoking – including tobacco taxes, graphic warning labels and advertising bans – which the tobacco industry had opposed in the past.

“WHO will not partner with the Foundation. Governments should not partner with the Foundation and the public health community should follow this lead,” it said.

The foundation’s founder and president-designate, Derek Yach, a former senior official at the WHO, said more collaboration, not less, was needed to win the war on smoking.

“I am deeply disappointed, therefore, by WHO’s complete mischaracterisation of the nature, structure and intent of the Foundation in its recent statements – and especially by its admonition to others not to work together.”

He said the foundation was a non-profit organization with strict rules to insulate it from the influence of the tobacco industry, and its research agenda would be subject to peer review.

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Progress Made on Robot-assisted Kidney Transplantation

Progress Made on Robot-assisted Kidney Transplantation

NEW YORK (Reuters Health) – When performed in selected patients by surgeons with specialized experience, robot-assisted kidney transplantation (RAKT) can result in “low complication rates, rapid recovery, and excellent graft function,” researchers in Europe conclude.

The surgeons were trained in an animal laboratory before performing RAKT in humans and were proctored during that training and their first four human RAKT procedures. Patients were selected for RAKT because of body size, lack of previous abdominal surgery, and other pertinent criteria.

Given that patients with end-stage renal disease are typically immunocompromised, the researchers hypothesized that such patients might benefit significantly from minimally invasive kidney transplantation. They call their study “the first and largest reported multicenter prospective study on RAKT.”

In this non-randomized investigation, they enrolled 120 nonconsecutive patients (62.5% male) at eight centers. The cohort had a median age of 43, a median BMI of 25.2, and a median dialysis duration of 365 days. Nearly all of the kidneys (98%) came from living donors. Minimum follow-up was one month.

Postoperative complications, occurring in no more than one per patient, included one case of wound infection, three cases of ileus, four cases of bleeding (3 required transfusion), one case of deep-vein thrombosis requiring anticoagulant drugs, one case of lymphocele requiring percutaneous drainage, three cases of transplantectomy due to massive arterial thrombosis, and five cases in which surgical exploration was performed for intraperitoneal hematoma.

Dr. Lloyd E. Ratner, director of renal and pancreatic transplantation at Columbia University Medical Center, New York, told Reuters Health in a phone interview that any new procedure should pass three tests: Is it technically feasible, is it safe, and does it bring better results? RAKT had been shown to be technically feasible, he noted, and the new study shows that its safety is comparable to that of open surgery.

“From an incremental standpoint, they’re making progress,” he said, but “I don’t think they’re there yet. . . . No one has reported yet that there’s an advantage to doing these procedures robotically.”

Dr. Ratner noted the lack of a control group in the current study and the paucity of information on how patients were selected for RAKT, although the authors acknowledged possible selection bias and other limitations of their study.

“The cost of the surgical robot is a big issue,” Ratner added, in part because surgical robots are at present a monopoly. “To an extent, it has been a device in search of an indication.”

The study’s corresponding author did not respond a request for comment.

SOURCE: http://bit.ly/2fmB3Rb

Eur Urol 2017.

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Sep 29 Cardiology News

Sep 29 Cardiology News

Oxygen therapy in stroke, physical activity, hospital rankings, MRI labeling of cardiac devices, and PFO closure are discussed in this week’s podcast.
theheart.org on Medscape



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U.S. Senators Close to Bipartisan Deal on Health Exchanges -Schumer

U.S. Senators Close to Bipartisan Deal on Health Exchanges -Schumer

WASHINGTON (Reuters) – Two U.S. senators from both parties are close to finalizing a bipartisan deal to shore up the health insurance exchanges created under Obamacare, the chamber’s top Democrat said on Thursday.

The move, which Senate Democratic Leader Chuck Schumer said was “on the verge” of completion, would stabilize the market for individuals who buy their own insurance plans on the federal or state-based exchanges.

The potential agreement comes after Republicans have repeatedly failed to carry out their years-long pledge to repeal and replace the 2010 Affordable Act, former Democratic President Barack Obama’s signature healthcare overhaul.

Schumer said Senate Health, Education, Labor and Pension Committee Chairman Lamar Alexander, a Republican, and ranking Democrat Patty Murray had resurrected a bipartisan approach, which had been cast aside amid the latest near-vote on a repeal bill.

Alexander and Murray had been working to protect the government payments made to insurers to help reduce medical expenses for low-income Americans enrolled in Obamacare. Alexander also wanted states to have more flexibility to design insurance plans under the program.

“They both inform me that they’re on the verge of an agreement, a bipartisan healthcare agreement to stabilize markets and lower premiums,” Schumer said on the Senate floor on Thursday.

The pact could buoy health insurance companies, which came out forcefully against the Republican repeal effort and have faced uncertainty since the November election of Republican President Donald Trump, who vowed to sink the law.

While the majority of insured Americans receive coverage through their employers or government programs such as Medicare and Medicaid, more than 10 million people have individual plans through the online exchanges, and about 11 million are expected to sign up next year.

Most of these consumers receive income-based tax credits and subsidies to reduce costs. Insurers have filed their premium rates for 2018, many of which are expected to rise at least 20 percent because of uncertainty that the government will continue paying some of those subsidies.

Despite those worries, insurers on Wednesday signed contracts with the government that will result in every U.S. county having at least one company selling Obamacare plans.

Trump has signaled that his administration would take other action to unwind the law, and on Wednesday said he would sign an order next week allowing people to buy insurance coverage across U.S. state lines.

Republican Senator Rand Paul, who has been pushing for the move, says Trump can do this by legalizing nationwide health associations that individuals could then join.

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Happy 350,000th Birthday: Study Pushes Back Homo Sapiens Origins

Happy 350,000th Birthday: Study Pushes Back Homo Sapiens Origins

WASHINGTON (Reuters) – Genetic data from the skeletal remains of seven people who lived centuries ago in South Africa’s KwaZulu-Natal Province is offering intriguing new evidence that our species, Homo sapiens, is older than previously believed.

Scientists said on Thursday they sequenced the genomes of the seven individuals including a boy who lived as a hunter-gatherer at Ballito Bay roughly 2,000 years ago. In doing so, they were able to estimate that the evolutionary split between Homo sapiens and ancestral human groups occurred 260,000 to 350,000 years ago.

Until recently, the prevailing belief was that Homo sapiens arose a bit before 200,000 years ago. The new study and fossil discoveries from Morocco announced in June indicate a much older origin.

Homo sapiens emerged on the African landscape following millions of years of human evolution, including a split 600,000 to 700,000 years ago from the lineage that led to the now-extinct Neanderthals. The period from that split until the advent of our species was a critical one.

“In this time period, some genetic changes may have happened that make us humans who we are today, and distinct from, for example, Neanderthals,” said population geneticist Mattias Jakobsson of Uppsala University in Sweden, co-leader of the research published online September 28 in Science.

“The reconstruction of deep human history in Africa is becoming increasingly robust when the dating of fossils, such as those from Morocco, the Stone Age archaeological record and human DNA come together to highlight interesting periods in our evolutionary past,” added study co-leader Marlize Lombard, a University of Johannesburg professor of Stone Age archaeology.

The Morocco findings reported in June by other researchers involved fossil skulls, limb bones and teeth roughly 300,000 years old that they concluded were from Homo sapiens.

“The age of those fossils at 300,000 years also falls within our new estimate for the emergence of Homo sapiens. They show a combination of modern and archaic features, which could indicate a transitional phase in our evolution,” Lombard said of the Moroccan remains.

Scientists also have concluded that a 260,000-year-old partial cranium from Florisbad, South Africa, also represented Homo sapiens.

There is broad agreement among scientists that Homo sapiens originated in Africa. But the recent discoveries have suggested our species arose not in one locale like east Africa but in multiple places, a more complex so-called pan-African origin that the new genetic research seems to support.

SOURCE: http://bit.ly/2ybjpaT

Science 2017.

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Psoriasis Patients Face Increased Risk of Heart Attacks and Death

Psoriasis Patients Face Increased Risk of Heart Attacks and Death

(Reuters Health) – People with psoriasis, a chronic inflammatory disease, may be more likely than others to experience heart attacks and strokes at least in part because inflammation damages their vascular system, a recent study suggests.

The longer people had lived with psoriasis, the more inflammation they had in their blood vessels, the analysis of imaging tests for 190 psoriasis patients found.

While these imaging tests didn’t connect vascular inflammation to an increased risk of heart attacks and strokes, researchers also examined data on roughly 87,000 Danish adults with psoriasis and another 4.2 million people without the condition. They found each year people lived with psoriasis was associated with a 1% increase in the future risk of cardiovascular events.

“It has been suspected that long-term exposure to low-grade systemic inflammation may increase the risk of cardiovascular events, but the effect of disease duration on the relationship between psoriasis and cardiovascular disease has been unclear,” said lead study author Dr. Alexander Egeberg of Gentofte Hospital in Copenhagen.

The inflammation in psoriasis is very similar to, and in many cases can overlap with, the inflammatory processes that contribute to atherosclerosis, Egeberg said.

Even though plenty of previous research has linked psoriasis to heart disease, the current results offer fresh evidence that living longer with systemic inflammation can increase the risk of heart attacks and strokes even for psoriasis patients who don’t have other risk factors for heart disease such as smoking, diabetes or advanced age, Egeberg added.

All of the patients in the imaging portion of the study had mild to moderate psoriasis.

On average, they were around 54 years old and had been living with psoriasis for roughly eight years.

The duration of psoriasis was associated with increased vascular inflammation even after accounting for traditional risk factors for cardiovascular disease such as smoking and a family history of heart attack or stroke.

In the separate analysis of the Danish population, researchers followed people for an average of almost five years.

During this period, 152,122 people without psoriasis had major events like a heart attack or stroke, which translates into about 8 people out of every 1,000 in the population each year.

Over that same time, 4,472 people with psoriasis had major events like a heart attack or stroke, which translates into about 11 people out of every 1,000 in the population each year.

One limitation of the study is that researchers lacked data for the Danish population on other factors that influence cardiovascular health such as obesity and exercise habits, the authors note in the Journal of the American Academy of Dermatology, online August 18.

Even so, patients should be aware that psoriasis can make cardiovascular problems more likely, said Dr. Lawrence Eichenfield of Rady Children’s Hospital and the University of California, San Diego.

“There is some evidence that certain systemic medications that treat psoriasis potentially decrease the inflammation and can decrease the psoriasis-associated cardiovascular risks,” Eichenfield, who wasn’t involved in the study, said by email. “The psoriasis treatment options should be discussed with a dermatologist.”

SOURCE: http://bit.ly/2fAzyPm

J Am Acad Dermatol 2017.

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AHA Statement Adds Meditation to CV Risk-Reduction Strategies

AHA Statement Adds Meditation to CV Risk-Reduction Strategies

DALLAS, TX — Meditation may be considered as an adjunct to standard guideline-directed cardiovascular risk-reduction practices that include a heart-healthy lifestyle and treatment for high cholesterol and hypertension, according to the first-ever scientific statement on meditation from the American Heart Association (AHA)^[1].

“Despite numerous advances in the prevention and treatment of atherosclerosis, cardiovascular disease remains a leading cause of morbidity and mortality in the US and developing world,” Dr Glenn N Levine (Baylor College of Medicine, Houston, TX), chair of the writing group of the AHA scientific statement, told theheart.org | Medscape Cardiology.

“Meditation, which is becoming increasingly popular and recognized for its benefits, may be an inexpensive and widely available adjunct to standard therapies for reduction of cardiovascular risk,” he said.

The statement was published online September 28, 2017 in the Journal of the American Heart Association.

The authors note that multiple studies have shown meditation can have long-standing beneficial effects on the brain, which provide some “biological plausibility” for beneficial effects on the physiological basal state and on cardiovascular risk. Therefore, the AHA commissioned the writing group to systematically review relevant data on the potential benefits of meditation on cardiovascular risk.

Studies on combination mind-body practices, such as yoga and Tai Chi, were excluded, since the physical activity included in these practices has an established beneficial effect on cardiovascular risk.

The group reviewed studies of “sitting” meditation practices including a variety of common forms such as: Samatha meditation; Vipassana meditation (insight meditation); mindful meditation; Zen meditation (zazen); Raja yoga meditation; loving-kindness (metta) meditation; transcendental meditation; and relaxation response.

“Overall, studies of meditation suggest a possible benefit on cardiovascular risk, although the overall quality and, in some cases, quantity of study data are modest,” the writing group says. More specifically, meditation may be associated with decreased levels of stress, anxiety, and depression and improved quality of sleep and overall well-being, they note.

Meditation may also help lower blood pressure, although there is insufficient evidence to determine whether or how much meditation may lower blood pressure in a given individual, the group says.

The data also suggest that meditation may help individuals quit smoking and might be associated with a decreased risk of MI, although the studies on this were limited and more studies are needed before any conclusions can be made, the group says.

“I found the results of our analyses encouraging in that regular meditation may decrease cardiovascular risk,” Levine told theheart.org | Medscape Cardiology, “although clearly more research is needed before any definitive conclusions may be made.

“Our message to patients and practitioners is that standard, guideline-directed lifestyle and medicinal interventions remain the primary way to prevent and treat cardiovascular disease, but for those interested in regular meditation, at this time this seems a reasonable adjunctive lifestyle modification,” Levine said.

“Future studies, to the degree possible, should utilize randomized study design, be adequately powered to meet the primary study outcome, strive to achieve low dropout rates, include long-term follow-up, and be performed by those without inherent bias in outcome,” the writing group concludes.

According to the National Health Interview Survey, 8% of US adults practice some form of meditation. Other data suggest that an estimated 14% to 24% of patients with heart disease have participated in some form of mind-body therapy, and 2% to 3% have used some form of meditation.

Levine has no relevant financial relationships. Disclosures for the coauthors are listed in the paper.

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PCSK9 Inhibitors: No Short-term Diabetes Risk in Meta-analysis

PCSK9 Inhibitors: No Short-term Diabetes Risk in Meta-analysis

BARCELONA, SPAIN — Taking proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors to reduce LDL cholesterol is associated with a small increase in HbA_1c levels, but this does not translate into increased risk of new or worsening diabetes, at least with 42 weeks of treatment, suggests a large meta-analysis^[1].

“In the short term, there is an increase in glycemia and HbA_1c , but at this point, with 1.5 years of follow-up, we did not show a clear increase in the risk of incident type 2 diabetes,” Dr Luiz Sérgio Carvalho (University of Campinas, São Paulo, Brazil) said at a press briefing prior to his presentation of the study here at the European Society of Cardiology (ESC) 2017 Congress.

“The effect on type 2 diabetes was apparent only in individuals who achieved very low levels of LDL cholesterol after treatment,” he said, referring to a related exploratory analysis that suggested more intense LDL-C lowering with PCSK9 inhibitors and treatment longer than 1 year were associated with new or worsening type 2 diabetes.

“The small but probably significant risk is probably a smaller effect than the cardiovascular benefit [of] the medications,” Carvalho told theheart.org | Medscape Cardiology.

“The increases in the glycemic indexes were very small, and we just have to [watch] for the future analyses of the trials, with longer follow-up, and see if there will be an increased risk of type 2 diabetes, Carvalho said.

“It’s sounding rather familiar like the statin story—a minor effect on glycemia but clearly overwhelmingly positive effects of these agents” on cardiovascular risk, commented Dr Louise Bowman (University of Oxford, UK), who cochaired the session where Carvalho’s formal presentation was made.

Session cochair Dr Robert G Xuereb (The Heart Clinic, Ta’ Xbiex, Malta) noted study limitations include that “it was a short-term follow-up and a nonhomogenous study group, so obviously we need to have more data, and this study has served to draw awareness to this issue.”

Importantly, the PCSK9 inhibitor evolocumab (Repatha, Amgen) was not associated with worsened or incident diabetes over 2 years in a prespecified analysis of the FOURIER trial, which was presented this month at the European Association for the Study of Diabetes (EASD) 2017 Annual Meeting and simultaneously published in Lancet Diabetes and Endocrinology^[2].

Lower Cholesterol, but With Risk of Diabetes?

In the SPIRE and FOURIER trials, a 60-mg/dL reduction in LDL cholesterol on PCSK9 inhibitors was associated with 20% reduction in cardiovascular events, Carvalho said. But a PCSK9 loss-of-function genetic variant is associated with prediabetes and diabetes, so the researchers aimed to determine the effect of PCSK9 inhibitors on glucose levels and potential new or worsening diabetes.

The team conducted a meta-analysis of phase 2 and phase 3 randomized controlled trials of PCSK9 inhibitors vs placebo (control) that were at least 12 weeks long, with primary outcomes of change in HbA_1c and fasting blood glucose from baseline, and secondary outcomes of risk of incident or worsening type 2 diabetes.

They identified 20 randomized PCSK9 inhibitor trials with a total of 68,123 participants that included the GAUSS and ODYSSEY trials of alirocumab (Praluent, Sanofi/Regeneron), DESCARTES, MENDEL, GLAGOV, and FOURIER trials of evolocumab, and the SPIRE trials of bococizumab (Pfizer). The Pfizer drug is no longer in development.

Aside from the short follow-up periods in the included studies, important limitations of the analysis include a low incident rate of diabetes, about 3%, and no information on how antidiabetic medications were used, the researchers note.

At baseline, the participants had a mean fasting plasma glucose of 103 mg/dL and a mean HbA_1c of 5.89%; 28% had diabetes. They had a mean age of 60, 58% were male, 84% were white, 61% had hypertension, 39% had CAD, and 18% were smokers.

After a mean follow-up of 42 weeks, patients taking a PCSK9 inhibitor had a fasting plasma glucose that averaged 1.88 mg/dL higher compared with control patients (P<0.001). They also had had an HbA_1c that averaged 0.032% higher compared with control patients (P<0.001).

However, these glycemic changes did not translate into increased risk of either new or worsening diabetes (RR 1.04, 95% CI 0.95–1.15; P=0.43) or new type 2 diabetes (RR 1.04, 95% CI 0.90–1.14; P=0.35) over a mean follow-up of 1.5 years.

Nor were PCSK9 inhibitors associated with increased risk of incident type 2 diabetes diagnosis considering only trials with a follow-up exceeding 48 weeks (RR 1.06, 95% CI 0.96–1.17; P=0.26).

Carvalho said there was small significant risk of incident or worsening type 2 diabetes in the exploratory analyses, adjusted for age and sex, among patients whose LDL cholesterol had been reduced by at least 55% and to 30 mg/dL or lower and who had been receiving a PKSK9 inhibitor for more than a year.

The study was funded by study was sponsored by the State University of Campinas (UNICAMP). The authors have no relevant financial relationships.

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Price Resigns as HHS Secretary Over Travel Controversy

Price Resigns as HHS Secretary Over Travel Controversy

Engulfed by the controversy over his expensive government trips aboard charter and military aircraft, Tom Price, MD, today resigned from his post as secretary of the Department of Health and Human Services (HHS).

Dr Price, an orthopedic surgeon and former Republican member of the House of Representatives from Georgia, served less than 8 months as head of HHS. The Senate narrowly confirmed his nomination by President Donald Trump on February 10.

His position appeared shaky when Politico reported last week that he had taken more than two dozen private chartered flights in lieu of commercial flights on HHS business since May, costing taxpayers some $400,000. The revelation angered Trump, who publicly suggested that Dr Price’s job wasn’t safe. Dr Price said that although he hadn’t broken the law, he would stop using chartered flights for frugality’s sake and reimburse the government nearly $52,000. This figure covered the cost of his seats on past flights, but not the entire cost of booking the aircraft.

Then Politico broke the story this week that military aircraft had taken Dr Price to Africa, Asia, and Europe, adding another $500,000 in government-paid travel expenses to the tab.

Dr Price assumed the post of HHS secretary in almost as much controversy as he left it, beginning as soon as Trump nominated him late last year. His staunch opposition to the Affordable Care Act and voting record on issues such as abortion and LGBT rights alienated many physicians, although he did receive a guarded endorsement from the American Medical Association.

Dr Price’s extensive investments in healthcare companies opened him up to accusations of insider trading because those companies could be helped or hurt by legislation he supported. Dr Price countered that these investments were ethical, but promised to sell the stock when he became HHS secretary.

Follow Robert Lowes on Twitter @LowesRobert

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Age of Transfused Blood Does Not Affect Mortality

Age of Transfused Blood Does Not Affect Mortality

Transfusing critically ill patients with the freshest available red cells, rather than with standard-issue (oldest available) red cells, provides no clinically meaningful benefits, a new study suggests.

D. James Cooper, MD, Monash University, Melbourne, Victoria, Australia, and colleagues published the results of the TRANSFUSE trial online September 27 in the New England Journal of Medicine.

“The age of transfused red cells did not affect 90-day mortality among critically ill adults,” the authors write.

To minimize blood disposal, blood banks typically dispense the oldest units of available blood first. However, as red cells age during storage, they undergo biochemical, metabolic, and structural changes that have been referred to as the “storage lesion.” 

According to the authors, transfusion of older red cells has been associated with a range of adverse effects, including increased morbidity and mortality among critically ill patients.

The researchers therefore conducted a multicenter, randomized trial to compare the effect of transfusing the freshest available red cells with that of standard-issue red cells in 4919 high-risk, critically ill patients. The trial took place from November 2012 through December 2016 at 59 centers in five countries.

The researchers randomly assigned 2457 patients to the short-term storage (mean storage duration, 11.8 days) group and 2462 patients to the long-term storage (mean storage duration, 22.4 days) group.

The primary outcome was 90-day all-cause mortality.

At 90 days, 610 patients (24.8%) in the short-term group and 594 (24.1%) in the long-term group had died — an absolute risk difference of 0.7 percentage points (95% confidence interval [CI], –1.7 to 3.1 percentage points), which did not reach statistical significance (P = .57)

And at 180 days, the absolute risk difference was 0.4 percentage points (95% CI, –2.1 to 3 percentage points; P = .75).

For secondary outcomes, more patients in the short-term group experienced febrile nonhemolytic transfusion reactions (5% vs 3.6%; absolute risk difference, 1.4 percentage points; 95% CI, 0.3 – 2.6 percentage points; odds ratio [OR], 1.42; 95% CI, 1.07 – 1.88; P = .01). And the results were similar after adjustment (adjusted OR, 1.45; 95% CI, 1.09 – 1.93; P = .01).

However, the study showed no statistically significant differences between the groups for various other secondary outcomes: 28-day mortality (P = .61), rates of persistent organ dysfunction or death at 28 days (P = .39), new bloodstream infections (P = .65), days alive and free of mechanical ventilation (P = .81) or renal-replacement therapy (P = .97) at 28 days. or intensive care unit duration of stay (P = .86).

“There was no benefit associated with the freshest available red cells with regard to the primary or secondary outcomes,” the authors note, concluding that these findings “support the current international usual practice of transfusing patients with the oldest red cells available.”

“This multicenter study adds a lot of clarity to a topic that hits home for our transfusion medicine community,” Justin D. Kreuter, MD, the medical director of Mayo Clinic’s Blood Donor Program in Rochester, Minnesota, told Medscape Medical News.

He emphasized that the current standard practice of issuing blood “first in, first out” ensures that the greatest number of blood donations are transfused. “However, our primary duty is to our patients,” he stressed. “This study affirms that our standard practice of issuing oldest blood units, which ensures optimal use of our limited blood inventories, is also best for our patients.”

He expressed surprise that younger units of blood were associated with significantly more febrile nonhemolytic transfusion reactions. “Although this type of reaction is not fatal, it can be uncomfortable for patients and certainly increases blood wastage,” he noted.

This study was supported by grants from the Australian National Health and Medical Research Council (NHMRC), the Health Research Council of New Zealand, and the Irish Health Research Board and by funding from the Australian Red Cross Blood Service. During the conduct of this study, five authors reported receiving grant support from the Australian NHMRC, three authors reported receiving grant support from the Health Research Council of New Zealand, one author reported receiving grant support from the Australian Red Cross Blood Service, two authors reported receiving grant support from the Irish Health Research Board, and two authors reported receiving grant support from the Australian National Blood Authority. One author reported receiving nonfinancial support for data collection and investigation from the Australian Red Cross Blood Service. One author also reported being a principal investigator on the INFORM CIHR grant, but not a site investigator role for INFORM. Outside the submitted work, one author reported receiving consulting fees for Eustralis Pharmaceutical Ltd, and another author reported serving as a member of the Blood Service Medical Advisory Committee of the Australian Red Cross Blood Service. The remaining authors have disclosed no relevant financial relationships.

N Engl J Med. Published online September 27, 2017. Abstract

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Cardiac Death During Triathlon 'Not Rare'

Cardiac Death During Triathlon 'Not Rare'

MINNEAPOLIS, MN — Over a 30-year period, 135 triathlon participants died or suffered cardiac arrest during USA Triathlon (USAT)–sanctioned events, a new study shows. The vast majority were men over 40 years of age, and two-thirds of deaths occurred during the swim segment^[1].

“Deaths and cardiac arrests during the triathlon are not rare” and exceed the one fatal event per 100,000 participants reported for marathon racing, the researchers, led by Dr Kevin Harris (Minneapolis Heart Institute Foundation, MN) conclude.

Their findings were published September 19, 2017 in the Annals of Internal Medicine.

From 2006 to 2015, the period for which the researchers had the most complete data, the incidence of fatal events was 1.74 per 100,000 participants.

The researchers reviewed data assembled from multiple sources, including USAT, the governing body for multisport disciplines in the US, personal reports from interested parties, and the US National Registry of Sudden Death in Athletes, which uses news media, internet searches, LexisNexis archival databases, and news clipping services to find cases.

The number of finishers was used as a surrogate for the number of participants. The researchers made a “conservative projected estimate” that there were more than 9 million race finishers during the study period that was based on the actual number of finishers calculated using USAT records covering the 2006–2015 period, Harris said in an interview. Additional information on victims and race conditions was obtained through contact with next of kin and race directors.

“I think that our data going back to the 1980s and our denominator information [of more than 9 million finishers] allows us to be relatively precise in determining who are the people at greatest risk,” Harris told theheart.org | Medscape Cardiology.

Harris presented preliminary data from this study at the American College of Cardiology annual meeting in 2016.

From 135 total events, 120 were cardiac-related (107 sudden deaths and 13 resuscitated cardiac arrests) and 15 were related to blunt trauma. All of the trauma-related deaths were incurred during the bike segment—10 involved motor vehicles and five were related to falls or collisions with stationary objects, such as guard rails and trees.

Autopsy reports were available for 61 racers and showed cardiovascular abnormalities in 27 (44%). Of those, 18 were found to have significant atherosclerotic coronary artery disease, defined as >50% narrowing in the left main coronary artery or >70% in the other major coronary arteries.

“Was it coronary disease that caused these deaths, or did the athletes drown or have an arrhythmia and drown?” asked Harris. “Autopsy is really good for showing anatomic lesions, but it doesn’t tell us if the patient had, say, an arrhythmia that led to the death. I think in most cases, we really don’t know for sure why the athlete died.”

Three decedents were found to have evidence of hypertrophic cardiomyopathy and two additional athletes had mitral-valve prolapse (one of whom had a history of Wolff-Parkinson-White syndrome).

Other relevant findings included (one each): a congenital coronary anomaly, an ascending aortic dissection with rupture, a spontaneous renal-artery dissection, and an arrhythmogenic right ventricular cardiomyopathy.

The majority of events (85%) occurred in men, with the risk increasing incrementally with each decade. Of the 115 deaths or cardiac arrests in men, 103 occurred in racers over the age of 40.

The rate of deaths and cardiac arrests per 100,000 participants was more than threefold higher for men aged 40 years or older than for those younger than 40 years (8.25 vs 2.49 events per 100,000 participants). Risk topped out at 18.6 events per 100,000 male participants in the >60 years  category.

Whether screening might save lives in this population is an open question, but Dr Reginald Ho (Thomas Jefferson University Hospital, Philadelphia, PA), who with Dr Karen Glanz (University of Pennsylvania, Philadelphia) wrote an accompanying editorial^[2], thinks mandated preparticipation screening might “not be popular.”

“When you get beyond a certain age, you kind of do what you want to do, and a lot of people don’t realize there is an inherent risk with exercise or they don’t realize they themselves are at risk, particularly if they have never had any problems before,” he said in an interview.

He does feel that greater efforts should be made to educate older athletes, “especially men over 40 years of age,” about the signs and symptoms of cardiovascular disease and the possible risks of participating in strenuous sports like the triathlon.

“They should at least get checked and make sure that if they have any cardiovascular symptoms that those are not ignored,” he said.

For his part, Harris thinks it is reasonable for clinicians to use these data as part of a discussion on risk with an older patient who wants to participate in an endurance sport and may or may not have established coronary artery disease.

“One group is those with established disease, but the bigger group is those at risk who don’t know they are at risk because they think that since they exercise and are relatively healthy, they haven’t been laying down plaque in their arteries.”

Is Swimming More Dangerous?

Ninety of 135 deaths and cardiac arrests (67%) occurred during the swim segment, which is the first event in the triathlon. Harris offered several causative hypotheses to explain this finding.

“We don’t really understand why the swim was associated with more events, but one thought is that your adrenalin is probably going to be higher at the very beginning of the race, when you’re first entering the water, but also adverse conditions, the very close proximity of other swimmers can make it hard to get into your usual endurance-sport groove,” said Harris.

Although it’s a possibility that has not been tested, Ho doubts swimming is an inherently riskier activity than biking or running in this “very heterogeneous population.” Rather, he suspects the increased event rate seen during the swim could be related to logistical issues around detecting, reaching, rescuing, and treating an athlete who runs into trouble in the water.

“If someone collapses during the run, you may be able to get them defibrillated pretty quickly,” he said. “In the water, first of all there is the risk of drowning, but even when you get to them and drag them out of the water, you can’t immediately put a defibrillator on them until they are on land and dried off. It might be just a few seconds or minutes, which could make a big difference in outcome.”

Interestingly though, the length of the swim segment (ranging from ≤750 m to one mile or more) did not appear to affect the risk of sudden death or cardiac arrest. Almost half (49%) of events occurred in shorter-swim events, 24% in intermediate events, and 17% in the swim segment of long-distance triathlons.

The current study is an expansion of an earlier effort that examined sudden death in USA Triathlon–sanctioned event over a 3-year period, from January 2006 to September 2008^[3]. In that study, Harris’s group identified 14 deaths in 14 triathlons among 922,810 finishers, 11 of which were in men and 13 of which occurred during the swim.

Since the triathlon’s first appearance as an Olympic sport in 2000, the event has surged in popularity. According to data from USAT, the governing body for the sport in the US, more than 4300 sanctioned multisport events involving more than 470,000 participants took place in 2015 alone^[4].

Members ages 40 to 49 comprise the largest sector of USAT annual membership at more than 30% of the overall membership base.

The study was funded by the Minneapolis Heart Institute Foundation. Harris reports no relevant financial relationships.  Disclosures for the coauthors are listed in the paper. Ho and Glanz report no relevant financial relationships.

For more from theheart.org Medscape Cardiology, follow us on Twitter and Facebook.

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FDA Approves New Fast-Acting Insulin, Fiasp, for Diabetes in Adults

FDA Approves New Fast-Acting Insulin, Fiasp, for Diabetes in Adults

The US Food and Drug Administration (FDA) has approved a new faster-acting, mealtime version of insulin aspart (Fiasp, Novo Nordisk) for the treatment of type 1 and type 2 diabetes in adults.

Fiasp (insulin aspart injection 100 units/mL) is a new formulation of the company’s NovoLog, to which niacinamide (vitamin B₃) has been added to help increase the speed of the initial insulin absorption. Fiasp is designed to be dosed at the beginning of a meal or within 20 minutes after starting a meal, as the insulin will appear in the blood approximately 2.5 minutes after dosing.

Fiasp will be available in a prefilled delivery device, the FlexTouch pen, and a 10-mL vial. It is not approved for use in insulin pumps in the United States.

The product was first launched in Canada in March and has been approved in the member states of the European Union.

In Canada, similar to the United States, it is not approved for use in insulin pumps but in the European Union, it is.

The EU approval of Fiasp for use in insulin pumps is based on a study comparing it with conventional insulin aspart lasting just 2 weeks, but other countries may require evidence from a longer-lasting trial, Diabetes Canada spokesperson Harpreet Bajaj, MD, MPH, a community endocrinologist in Toronto, Ontario, and a research associate at Mount Sinai Hospital, told Medscape Medical News in March.

One such study, called ONSET-5, is ongoing, comparing the efficacy and safety of faster-acting insulin aspart with NovoRapid (Novo Nordisk) over 16 weeks in adults with type 1 diabetes using insulin pumps. Novo Nordisk says ONSET-5 will complete in the third quarter of 2017 and the results will be reported at a medical meeting in 2018.

“Insulin pumps are a different ballgame; we need longer-term data to be sure,” Dr Bajaj commented.

Rapid-Acting Insulins Intended to Mimic Physiologic Response

“With Fiasp, we’ve built on the insulin aspart molecule to create a new treatment option to help patients meet their postmeal blood sugar target,” said Bruce Bode, MD FACE, president of Atlanta Diabetes Associates and associate professor at Emory University School of Medicine, Atlanta, Georgia, in a Novo Nordisk press release.

“The intention of rapid acting insulin therapy is to mimic, as much as possible, the natural physiological insulin response that occurs after meals, a process that is important for optimal A_1c management.”

The approval of Fiasp is based on results from the ONSET phase 3a clinical development program, which enrolled more than 2000 adults with type 1 and type 2 diabetes and showed efficacy and safety of Fiasp, administered both at mealtimes and after starting a meal.

The new product will launch at the same list price as NovoLog and will be offered with a savings card program for eligible patients with commercial insurance to reduce copays, the company says.

It will also be available to eligible patients through the Novo Nordisk patient-assistance program. Patients and caregivers can obtain more information and access to the Novo Nordisk patient assistance program by calling toll free at 866-310-7549.

Other “ultrafast”-acting insulins are in development, including Ultra-Rapid BioChaperone Lispro (Adocia), a newly formulated version of insulin lispro.

Follow Lisa Nainggolan on Twitter: @lisanainggolan1 . For more diabetes and endocrinology news, follow us on Twitter and on Facebook .

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Positive Topline Results for Cannabinoid Gel in Fragile X

Positive Topline Results for Cannabinoid Gel in Fragile X

A clear transdermal cannabinoid (CBD) gel (ZYN002, Zynerba Pharmaceuticals) improved key symptoms of fragile X syndrome in the phase 2 FAB-C study, the company reports.

Topline results of the open-label study in pediatric and adolescent patients with fragile X syndrome show that ZYN002 met its primary endpoint, having achieved a 46% improvement (P < .0001) in the total score of Anxiety, Depression, and Mood Scale (ADAMS) at week 12 compared to baseline.

ZYN002 also achieved clinically meaningful improvements in all measures of the Aberrant Behavior Checklist for Fragile X (ABC-FXS), which addresses the key symptoms of fragile X syndrome, including social avoidance, temper tantrums, repetitive movements, and hyperactivity.

According to the company, ZYN002 is the first and only pharmaceutically produced CBD formulated as a permeation-enhanced gel.

“This is a very difficult patient population, and we’re thrilled with the data. It gives us a step to now go forward and speak with the FDA and hopefully be in pivotal trials sometime in 2018,” Armando Anido, Zynerba’s chairman and chief executive officer, told Medscape Medical News.

The FAB-C study included 20 patients aged 6 to 17 years who had fragile X syndrome. The diagnosis was confirmed by molecular documentation of full mutation in the fragile X mental retardation 1 (FMR1) gene. ZYN002 treatment was started at a dose of 50 mg daily; the dose could be increased to 250 mg daily for the first 6 weeks. After the initial 6 weeks of therapy, there followed by a maintenance dosing period, which lasted through week 12. The gel is rubbed on the upper arm and takes 30 to 45 seconds to dry.

The study met the primary endpoint for change from baseline to week 12 in the total score of the ADAMS scale, which has been validated in patients with fragile X syndrome.

Table 1.

Primary Endpoint	Baseline Score	Week 12 Score	Change	Improvement
ADAMS total score	33.4	18.1	-14.1	45.8% (P < .0001)

 

Treatment with ZYN002 also led to improvement in scores on the general anxiety, social avoidance, compulsive behavior, manic/hyperactive behavior, and depressed mood subscales of the ADAMS.

Table 2.

ADAMS Subscales	Baseline	Week 12	Change	Improvement
General anxiety	10.0	4.6	-4.8	54.0% (P < .0001)
Social avoidance	10.2	4.8	-5.1	52.9% (P = .0002)
Compulsive behavior	2.8	1.4	-1.2	50.0% (P = .0262)
Manic/hyperactive	9.4	6.1	-2.7	35.1% (P = .0003)
Depressed mood	2.8	2.0	-0.9	28.6% (P = .1417)

 

Topline data were also positive for multiple secondary endpoints, including the ABC-FXS, Clinical Global Impression of Improvement (CGI-I), the Pediatric Anxiety Rating Scale (PARS-R), Visual Analogue Scales for Anxiety, Hyperactivity and Tantrum/Mood Lability, the Vineland Adaptive Behavior III, a quality of sleep measurement, and the Pediatric Quality of Life (PedsQL). “The results of the secondary endpoints reinforce the results demonstrated in the ADAMS,” the company said.

ZYN002 was well tolerated, with a safety profile consistent with previously released data from clinical trials, the company said. There were no severe adverse events and no drug-related gastrointestinal events, and no tetrahydrocannabinol (THC) was detected in plasma. Thirteen patients have enrolled in the open-label extension study.

“The symptoms of fragile X can be overwhelming to a patient and caregiver, so I’m very enthusiastic about the responses to ZYN002 that we saw during this study,” Honey Heussler, MBBS, of Children’s Health Queensland and lead investigator in the FAB-C study, said in the release. “These data are extremely promising, particularly the improvements in anxiety, social avoidance, and irritability as measured by scales including ADAMS, ABC-FXS, and PARS-R. Tolerability is essential in these patients, so I’m very pleased to see that ZYN002 was well tolerated in fragile X patients.”

Zynerba is also evaluating the use of cannabinoid gel in adult epilepsy patients who have focal seizures and for knee pain due to osteoarthritis.

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Radiation Therapy for Cancer: Feared, Misunderstood

Radiation Therapy for Cancer: Feared, Misunderstood

SAN DIEGO — “Radiation” is not a word obviously associated with healing and medicine but instead often raises specters of nuclear weapons, power plant disasters, and human injury, according to experts who spoke with Medscape Medical News here at the American Society for Radiation Oncology (ASTRO) 2017 Annual Meeting.

As a result, the specialty of radiation oncology needs to step into this information breach and educate patients, the public, and, in a different way, other medical specialties, said commentators.

Patients’ attitudes were a focus at a meeting press conference this week, where Narek Shaverdian, MD, from the University of California Los Angeles presented the results of a survey of 327 patients with breast cancer at their center who received radiation therapy.

Little is known about what patients think about the radiation therapy experience, he said. 

The survey revealed that nearly all (94%) of the women were initially fearful of receiving radiation and half (47%) had heard or read frightening stories of serious side effects from the treatment, reported Dr Shaverdian.

The most common initial fears related to damage to internal organs (40%), skin burning (24%), and becoming radioactive (7%).

David Beyer, MD, board chair of ASTRO, who attended the press conference as an observer, was not surprised.

“Most cancer patients have three thoughts in mind when you say radiation: Chernobyl; they think it causes cancer; and they remember an elderly aunt who had horrible radiation burns decades ago,” Dr Beyer told Medscape Medical News.

Patients with cancer are mostly an “older population” and thus can recall a previous era in radiation oncology when adverse events were more common, explained Dr Beyer, who is from the Cancer Centers of Northern Arizona in Sedona. He was not asked for comment but approached Medscape Medical News because he feels so strongly about the subject.

In breast cancer, the evolution of treatment technology and provider skill means that 90% to 95% of patients now report a “good” cosmetic outcome, he said, not citing any statistical source.

“It’s not uncommon to see a woman on follow-up [for breast cancer] and have to consult my notes to see which side was treated,” said Dr Beyer.

Paul Harari, MD, from the Carbone Cancer Center at the University of Wisconsin, Madison, and president-elect of ASTRO, echoed some of these comments.

“The word ‘radiation’ can invoke fear among patients and providers based on misconceptions about toxicity,” he told Medscape Medical News. He also acknowledged that the term “may conjure up worrisome images,” including terrorism.

The specialty needs to get the word out about sophistication of contemporary radiation oncology practice, said Dr Harari.

“A very important effort for the field of radiation oncology is to highlight the tremendous power and precision of radiation in modern cancer treatment,” he said.

To that end, ASTRO’s Board of Directors has recently endorsed an “elevate the profile” initiative. However, “we are only just beginning to develop tactics and tangibles,” said Dr Harari.

A higher profile might help with patients. The breast cancer patient survey from Dr Shaverdian revealed that 68% of respondents had, at the time of diagnosis, “little or no prior knowledge of radiation therapy.”

Doctors also need education, said Dr Shaverdian.

“Breast surgeons are influenced by fears and misconceptions of radiation therapy,” he said while discussing why radiation therapy is not more widely used in high-risk patients with breast cancer after mastectomy, despite recommendations to do so.

Dr Harari hinted at an underlying problem. “Beyond our specialty, there is a relatively limited understanding and appreciation of this remarkably effective modality of cancer treatment,” he said.

The new survey indicated that patients were not scarred by the experience. They completed the survey a median of 31 months (range, 6 to 61 months) after completing radiation therapy

Only eight women (3%) found the negative stories they previously read about radiation therapy to be true, and six women (2%) found the negative stories from family and friends to be true.

On the other hand, 90% reported that the actual experience to be “less scary” than anticipated.

With regard to short-term side effects, 83% reported the overall events to be better than or as expected. And 75%, 61%, and 78% of patients reported pain, skin changes, and fatigue, respectively, to be less than or as expected.

With regard to long-term side effects, 84% reported that these were better than or as expected. And 79%, 73%, and 70% found breast-related pain, size changes, and textural changes, respectively, to be less than or as expected.

In terms of patients’ disease stage, 18% had ductal carcinoma in situ; 38% had stage I; 34%, stage II; and 9%, stage III. Most (82%) underwent breast-conserving surgery. Among the survey respondents, radiation therapy was delivered as standard whole-breast (with or without regional nodal coverage), hypofractionated whole-breast, postmastectomy, and partial breast.

Brian Kavanagh, MD, MPH, from the University of Colorado, Denver, and the outgoing ASTRO president, wondered whether the study results about patients’ fears reflected the fact that any cancer diagnosis is a “frightening prospect.”

Dr Kavanagh moderated the press conference at which Dr Shaverdian spoke.

“It’s always a part of the conversation,” said Dr Kavanagh, who was referring to patient fear and anxiety expressed during an office/clinic visit.

He believes that patients who are not tech savvy (and cannot access online breast cancer information) or who lack financial resources are probably more likely to be fearful.

“I hope most are not incapacitated by fear. I don’t see that personally,” he said about patients in general.

Dr Kavanagh said the important thing is for radiation oncologists to address fears and misconceptions. There is also a built-in tool that enable clinicians to do so. The informed consent process before treatment covers potential side effects, he said, which will address many patients’ lingering and perhaps unspoken concerns.

Study author Dr Shaverdian offered one other insight. “We tried to be proactive in our clinic. We try to explain radiation therapy in simple terms — ‘It’s like an x-ray, but not to take a picture, but to actually treat.'”

One study author disclosed a financial relationship with Accuray. Dr Beyer and Dr Harari have disclosed no relevant financial relationships.

American Society for Radiation Oncology (ASTRO) 2017 Annual Meeting. Abstract 85. Presented September 25, 2017.

Follow Medscape senior journalist Nick Mulcahy on Twitter: @MulcahyNick

For more from Medscape Oncology, follow us on Twitter: @MedscapeOnc

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Woman Who Faked Cancer and Cure Is Fined $320,000 Over Hoax

Woman Who Faked Cancer and Cure Is Fined $320,000 Over Hoax

An Australian woman who falsely claimed not only to have had cancer but to have cured it using natural remedies and nutrition has now been fined $322,000 ($420,000 Australian) for misleading the public.

Belle Gibson, a 25-year-old entrepreneur who created a small health and wellness empire after claiming that she had had brain cancer and had cured it herself with the use of natural remedies, fabricated the entire scenario, according to an investigation conducted in 2015 by the Australian newspaper.

As previously reported byMedscape Medical News, an investigation conducted in 2015 by the Australian revealed multiple public contradictions since 2009 about nearly everything – including Gibson’s supposed age, illnesses, treatments, and miraculous recoveries.

In addition, she held fundraisers for charities, but the promised money was never donated.

Last year, Consumer Affairs Victoria launched legal action against her for false and misleading conduct in relation to her health and for unlawful fundraising appeals in 2013 and 2014. She was subsequently ordered to pay $30,000 toward the legal costs of Consumer Affairs Victoria.

Earlier this year, Gibson was found guilty of breaching sections of the Australian consumer law that states “a person must not engage in trade or commerce likely to mislead or deceive.”

She has now been issued a hefty fine by Debra Mortimer, a federal court justice.

Gibson had initially been facing $1.1 million in fines, but the court ordered that she instead pay $420,000 (Australian) because they did not see the point in issuing such a large fine, since she did not have the ability to pay it. As she had done during her trial, Gibson stayed away from court.

A Long, Strange Trip

Little is known about her life prior to 2009, or how much of it is factual. As reported in news.com.au, Gibson described her childhood and adolescence as being filled with extreme distress. She claims to have taken responsibility for an autistic younger brother and a mother with multiple sclerosis by 6 years of age and that she had suffered from severe obesity by age 11. By the time she was 12 years old, she moved out of her home and moved in with a classmate and then with a family friend. She says she never knew her father and became estranged from her mother.

Gibson claims that when she was 20 years old, her current health problems began, and she blames it on a reaction to a vaccine against human papillomavirus. She claims that she experienced vision, memory, and walking problems and that she subsequently suffered a stroke. Not long afterward, she claims she was diagnosed with a malignant brain tumor and that she was given 4 months to live.

After receiving chemotherapy and radiotherapy for 2 months, she passed out on the lawn of a Melbourne hospital. When she awakened, . Gibson says that she “had an epiphany.” The epiphany was that if she only had a few weeks left to live, this was not the way she wanted to live them. And although her physicians thought “she was mad” to refuse further treatment, she embarked on a healing program of natural remedies.

Contrary to predictions by her physicians, Gibson did not die.

In 2010, she gave birth to a healthy son, even though she had been told she could never have children. Two years later, she underwent a miscarriage at 5 months’ pregnancy.

In addition to her brain cancer, she claimed that a German magnetic therapist had diagnosed her with several other malignancies, including cancers of the blood, spleen, uterus, and liver.

Gibson then turned into something of a guru for natural healing. She developed a product called the Whole Pantry, which consisted of a website, a mobile phone app, and a recipe book.

Her $35 cookbook was published by Penguin Books in Australia and had been scheduled to be distributed in the United Kingdom and United States before it was cancelled by the publisher following reports that Gibson’s illness was all a hoax.

Gibson’s $3.79 app had been downloaded at least 300,000 times and was voted Apple’s Best Food and Drink App of 2013. The app was at one time supposed to be part of the recently launched Apple Watch.

She also reportedly ran two fundraising campaigns for various charities, but the bulk of money was never distributed. When questions arose concerning her fundraising activities in 2015, Gibson promised that she would make donations to the organizations which had never been paid after a fundraiser in 2013. She blamed “cash flow” problems for the delay.

Gibson also publicly claimed that she donated 25% of her company’s profits to various causes and reported that $300,000 had already been given to charity. But she soon backtracked on that, claiming that the contributions were in fact never made, because sales of her app were not as robust as she had anticipated. Gibson has been unable to provide a list of any charities that she made donations to, nor has she disclosed how much money the charities have been given.

Guilty as Charged

In 2015, Gibson confessed that “none of it was true.”

She earned a total of $322,00 during the course of her “career”; the court has found that just over $10,000 was made in donations, which was far less than what she claimed.

Gibson never showed up in court during her trial. She was found guilty in March of “most but not all” of the allegations that were levied against her by Consumer Affairs Victoria.

The fine that has now been issued to Gibson was for a variety of infractions, including failing to donate money from the proceeds of her wellness app and failing to fulfill a promise to pay $150,000 to a young boy named Joshua Schwartz who had an inoperable brain tumor.

“Ms Gibson expressly compared the terrible circumstances of young Joshua to her own, asserting she had the same kind of tumor as he did; a statement which was completely false,” Judge Mortimer stated in her ruling.

The infractions and amounts are as follows:

• $90,000 for failing to donate proceeds from the sale of The Whole Pantry app, as she had stated she would do

• $50,000 for failing to donate proceeds from the launch of The Whole Pantry app

• $30,000 for failing to donate proceeds from an event held in 2014 honoring Mothers Day

• $90,000 for failing to donate other company profits

• $150,000 for failing to donate 100% of 1 week’s app sales to the family of Joshua Schwarz

Physicians ― Get on the Ball

The case of Bell Gibson was highlighted in a Medscape commentary entitled “Are Evil People Influencing Your patients?,” by Art Caplan, PhD, from the Division of Medical Ethics, New York University Langone Medical Center, New York City. He said this case is an example of social media being used to disseminate health information by people who lack ethics and/or knowledge.

“Physicians need to know where to send patients for reliable information. Know the websites, find out about social media so that you can say, ‘Here is a vetted source from the American Cancer Society or the American Medical Association (or other expert professional groups) to help you deal with diseases,’ ” said Dr Caplan. “Do not leave your patients hanging, relying on whatever it is that pops up in the top 10 Google searches.”

The Internet is a powerful tool, he emphasized. “We are not going to censor it. We are not going to shut it down,” said Dr Caplan. “But I believe that medicine has to adapt to and address it. The case of Belle Gibson shows that if we do not do that, a lot of harm may come of it.”

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Brain Inflammation Tied to Depression, Suicidal Thoughts

Brain Inflammation Tied to Depression, Suicidal Thoughts

On individuals with major depressive disorder (MDD), particularly those who experience suicidal thinking, levels of translocator protein (TSPO), a marker of microglial inflammation, are increased, new research shows.

Investigators from the University of Manchester, United Kingdom, found significantly higher levels of TSPO in patients with MDD than in healthy control persons. Levels were particularly high in the anterior cingulate cortex (ACC), which suggests microglial activation. TSPO was also particularly elevated in the insula in patients with depressed and suicidal thoughts compared with those who did not have suicidal thoughts.

“The evidence for a link between depression and inflammation is quite compelling now, and there is also mounting evidence for a link between suicide and inflammation across a range of mental disorders,” lead investigator Peter S. Talbot, MD, told Medscape Medical News.

“If we can learn more about these links, it may lead to more effective prevention or treatments of depression and suicidal thinking by targeting specific aspects of the inflammatory process,” he added.

The study was published online August 12 in Biological Psychiatry.

The Living Brain

Inflammation in depression is a “promising avenue of research for new treatment strategies, based on evidence that at least a subset of individuals with MDD have higher levels of peripheral proinflammatory cytokines,” the authors write.

Previous research has found a high prevalence of depression in patients with inflammatory medical disorders, and there is evidence that inflammation may be associated with lack of response to antidepressants.

Peripheral inflammation can cause an inflammatory response in the brain in which the metabolism of tryptophan “is diverted from the production of serotonin to kynurenine, which is subsequently converted into the neurotoxic quinolinic acid by activated microglia and infiltrating macrophages and monocytes,” they note.

Research on animal models has supported this understanding of the neuroinflammatory pathway. Postmortem studies have found increased levels of quinolinic acid in the ACC of individuals with depression who had died by suicide. In addition, microglial and astrocytic activation has been found in the ACC, the thalamus, and the frontal cortex of patients with depression.

Evidence of an association between neuroinflammation ― specifically, microglial activation ― and suicidality has been based on postmortem studies. No previous research has specifically investigated the association between neuroinflammation and suicidality in living patients.

Positron-emission tomography (PET) scans and radioligands specific for the 18-kDa TSPO, a mitochondrial protein that is upregulated in activated glial cells, provide a useful index for measuring neuroinflammation in living patients.

The researchers set out “to investigate brain TSPO availability in MDD and to explore factors that might be associated with heightened inflammation” using the “prototypical” TSPO radioligand [¹¹C] (R )-PK11195 to measure brain TSPO availability in nonsmoking, medically healthy, and antidepressant-naive or antidepressant-free patients with moderate to severe depression.

Three areas of the brain were chosen as the focus of the study: the ACC, the prefrontal cortex (PFC), and the insula. These areas were chosen because in a previous study, TSPO levels in these areas were to be significantly elevated in patients with depression. These areas also play a role in mood regulation, and previous research has found that the ACC has a role in the association between inflammation and depression.

Markers of Inflammation

A secondary aim of the study was to explore the associations between brain TSPO levels, symptom severity, suicidal ideation, exercise levels, childhood adversity, and peripheral markers of inflammation.

“Most of the previous evidence is based on blood tests and postmortem brain samples, and relatively little has been known so far about what is going on in the living brain during a major depressive episode or suicidal thinking,” said Dr Talbot.

“PET is such an important imaging technique because it allows us to measure levels of a range of chemicals in the living brain and can provide evidence for microglial activation, which is, in turn, evidence for the presence of an inflammatory process in the brain,” he said.

To investigate these associations, the researchers compared 14 patients with moderate to severe MDD with 13 sex- and age-matched health control persons. The patients were 15 to 55 years old and had been diagnosed on the basis of DSM-IV criteria as having moderate to severe MDD. Depression was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) (mean score ± SD = 31 ± 4) and the Hamilton Depression Rating Scale (HDRS) (mean score ± SD = 20 ± 3). Seven of the 13 control persons were men (mean age of control persons ± SD = 33 ± 11 years).

Patients were required to be either antidepressant-naive or to have been free of antidepressant use for at least 8 months. All participants were required to be nonsmokers and to be medically healthy, as determined on the basis of on clinical history, physical examination, routine blood tests, and urine toxicology.

The researchers measured the participants’ body mass index (BMI), degree of childhood adversity (assessed using the Childhood Adversity Questionnaire), physical exercise (measured by the Godin Leisure-Time Exercise Questionnaire), and the levels of several inflammatory markers of inflammation in plasma (tumor necrosis factor–α [TNF-α], interleukin-6 [IL-6], IL-8, IL-1β, and C-reactive protein [CRP]).

TSPO availability ([¹¹C] (R)-PK11195 binding potential [BP_ND]) across the hypothesized regions (ACC, PFC, and insula) was higher by a mean of 39% in the patients with MDD than in the control persons. The finding was statistically significant (MANOVA, main effect of group: F _3,23 = 5.63, P = .005).

The highest increase was found in the ACC (67%); smaller elevations were found in the PFC (29%) and the insula (24%).

Univariate tests conducted on individual regions found that the elevation in ACC was of large effect size and was statistically significant (F _1,25 = 5.99, P = .022; partial η ² = 0.193; Cohen’s d = 0.95). The elevations in the PFC and the insula had small effect sizes and did not reach statistical significance.

“Surprising” Difference in Suicidal Patients

To analyze the effects of suicidal ideation on TSPO availability, the researchers stratified patients into those with and those without current suicidal thoughts (n = 9 and n = 5, respectively).

There were no significant difference in age, sex, BMI, or injected mass of radiotracer between the two MDD subgroups, and they were well matched for overall disease severity with respect to scores on the MADRS and HDRS.

The researchers found significant differences in TSPO availability among the groups (control persons, patients with suicidal thinking, and patients without suicidal thinking) across all three regions (MANOVA, main effect of group: F _6,46 = 4.22, P = .002).

Univariate tests on the individual regions found statistical significance and large effect size in the ACC (F _2,24 = 9.91, P = .001; partial η ² = 0.452) and the insula (F _2,24 = 4.59, P = .021; partial η ² = 0.277) and trend significance in the PFC (F _2,24 = 3.15, P = .061; partial η ² = 0.208).

Pairwise comparisons showed that TSPO availability in the ACC and the insula was significantly higher in patients with suicidal thinking than in those without suicidal thinking and that availability trended higher in the PFC. In addition, TSPO availability in the ACC was also significantly higher in patients with suicidal thinking than healthy control subjects.

The researchers found no significant correlations between BP_ND in any of the regions and symptom severity, illness duration, BMI, childhood adversity, or any of the peripheral inflammatory markers.

Likewise, there were no differences in concentration of peripheral inflammatory markers between patients with and those without suicidal thoughts. However, there was a negative correlation in patients with MDD between BP_ND in the ACC and their degree of physical exercise that reached trend significance (r = −0.47, P = .07).

“One surprising aspect of the results was the size of the difference in microglial activation between the suicidal and nonsuicidal depressed patients,” Dr Talbot commented.

“In one way, it’s not surprising, because it fits with the previous nonimaging literature. But I was surprised that the effect was so large that we could identify it so clearly in such relatively small subgroups,” he said.

He cautioned that because the groups were relatively small, the findings should be regarded as “preliminary and in need of confirmation in a larger study, but they are an important first step in helping us learn more about the links between suicidality and inflammation in the living brain.”

Future Targets

Commenting on the study for Medscape Medical News, Jonathan P. Godbout, PhD, professor in the Neuroscience Institute for Behavioral Medicine Research, Ohio State Wexner Medical Center, Columbus, described the study as “a good starting point to say inflammation in depression is real and is a target for inflammation” because “we need ways to determine neuroinflammation in living, breathing human beings instead of relying on postmortem studies.”

He cautioned that although TSPO is a well-validated, established marker of microglial activation, it is only one inflammatory marker among many, and “there is a lot more to microglial activation than change in a single marker.”

Nevertheless, “it is nice to have imaging techniques that can detect inflammation in humans,” said Dr Godbout, who was not involved in the study.

The research has important clinical implications, he stated. “I think scans like this can one day be used diagnostically, although they are expensive, because if you can identify the cell type generating inflammation in the brain, you have a target for intervention.”

Dr Talbot added that there are some take-home messages for practicing clinicians even now.

“Although PET scans for microglial activation are not yet at a point where they can be used diagnostically or to help guide treatment, there are lifestyle changes that patients with depression could take immediately that are broadly anti-inflammatory and may be helpful in reducing the intensity of their depression over time.”

These include smoking cessation; reducing weight, cholesterol, and blood pressure if they are elevated; and increasing physical exercise, since “our findings showed a trend for those depressed patients who had the highest levels of physical exercise to have the lowest levels of brain microglial activation.”

He noted that there are important implications for future research.

“The link between suicidality and microglial activation is intriguing and needs to be confirmed in a larger study with depressed patients and also investigated in a range of other disorders in which the risk of suicide is increased, such as bipolar disorder and schizophrenia,” he said.

If anti-inflammatory drugs prove effective in treating depression and suicidality, “it is likely that their effectiveness will be in particular subgroups of patients rather than all patients.” Research would be needed to identify those patients most likely to benefit from them.

Lastly, “it will be important to investigate whether nonmedication treatments for depression, such as CBT and lifestyle changes, can have anti-inflammatory effects in the brain as part of their mechanism of effectiveness.”

Financial support for the study was provided by Karl Herholz and the University of Manchester’s Magnetic Resonance Imaging Facility. The authors have disclosed no relevant financial relationships.

Biol Psychiatry. Published online August 12, 2017. Abstract

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Cognitive Dysfunction Linked to Increased Parkinson's Risk

Cognitive Dysfunction Linked to Increased Parkinson's Risk

Early cognitive dysfunction may be a significant risk factor for future risk for parkinsonian disorders, including Parkinson’s disease (PD), new research suggests.

Among more than 7300 study participants, those with low overall cognitive scores at baseline were at significantly greater risk for incident parkinsonism and for probable PD 8 years later than those with higher baseline scores.

Risk for parkinsonism was also increased for those with poor scores on a range of different types of tests, including letter-digit substitution and verbal fluency.

“The findings suggest that cognitive dysfunction can be considered a sign of prodromal PD,” the investigators, led by Sirwin K.L. Darweesh, MD, Department of Epidemiology, Erasmus MC University Medical Center, Rotterdam, the Netherlands, write.

Dr Darweesh told Medscape Medical News that although the investigators were not surprised to see the association between poor cognitive function and “short-term risk” of parkinsonism, it was interesting to see that the risk went beyond an 8-year interval.

“Furthermore, our observation that diverse domains of cognition, including executive, attention, cognitive speed, and memory, are already implicated in prodromal parkinsonism patients extends prior observations” in those with clinical parkinsonism, he said.

The findings were published online September 25 in JAMA Neurology.  

“Growing Urgency”       

Although previous research has shown that patients with PD often have cognitive dysfunction, “there is a scarcity of data on cognitive functioning before parkinsonism diagnosis,” the authors write.

“In clinical parkinsonism patients, most notably those with Parkinson’s disease, damage to the brain is already quite advanced at the time of diagnosis, rendering them less susceptible to putative disease-modifying interventions,” added Dr Darweesh.

“As a consequence, there is a growing sense of urgency to unravel the prodromal phase of common parkinsonism diseases.”

For the current analysis, the investigators assessed 7386 participants in the prospective, population-based Rotterdam Study (57.4% women; mean age, 65.3 years). Baseline cognition was assessed between January 2002 and December 2008 by using a battery of tests.

In the study cohort, 1.1% developed incident parkinsonism during a mean follow-up of 8.3 years. Of these participants, 72.2% were diagnosed with probable PD, and 30.4% had comorbid dementia.

In the 24 patients who had comorbid dementia, 10 developed it before onset of parkinsonism, while the others developed it afterwards.

Results showed that the participants who had low global cognition scores at baseline were more likely to have incident probable PD than those with higher scores at baseline (adjusted hazard ratio [HR], 1.52; 95% confidence interval [CI], 1.11 – 2.08). Changes in semantic fluency were also associated with probable PD (HR, 1.35).

The following table shows that low scores on several cognitive tests were significantly associated with increased risk for parkinsonism.

Table. Risk Factors for Incident Parkinsonism

Low Baseline Scores for:	HR (95% CI)
Global cognition	1.79 (1.37 – 2.33)
Letter-digit substitution	1.59 (1.22 – 2.04)
Verbal fluency	1.61 (1.23 – 2.08)
Inverted interference task on Stroop color word test	1.56 (1.25 – 1.96)

 

The association between poor baseline global cognition scores and incident parkinsonism remained significant past 8 years (HR, 1.59; 95% CI, 1.01 – 2.59). Even after exclusion of the participants who developed dementia, the HR was still a significant 1.72.

The likelihood ratio for parkinsonism development was 2.66 for those who had both cognitive impairment and “subtle motor signs” at baseline (95% CI, 1.64 – 4.32).

“Our data provide important insight” into the link between cognitive dysfunction and risk of parkinsonism within the general population, “especially given the fact that, to our knowledge, only 2 community-based studies have previously published data on this topic,” write the investigators.

Changing the Disease Course

In an accompanying editorial, Ethan G. Brown, MD, and Caroline M. Tanner, MD, PhD, both from the Movement Disorders and Neuromodulation Center at the University of California, San Francisco, write that the Rotterdam Study “provides an excellent setting” for looking into these issues.

“Because this is a large, community-wide cohort with low attrition, the results are broadly applicable,” the editorialists write.

However, noted limitations include the following: “the neuropsychological assessment was not as thorough as currently recommended” for assessing cognition in PD; the primary outcome was development of parkinsonism, including vascular and medication-induced versions, instead of development of PD; and “the study design precluded specialist adjudication of all PD diagnoses.”

Still, “these findings have numerous implications,” Dr Brown and Dr Tanner write.

They note that the association between changes in semantic fluency and probable PD echoes previous results and underlines the importance of giving this type of test early on. Another key finding was that patients with mild cognitive impairment, especially those with subtle motor signs, may have prodomal PD.

“This recognition can allow physicians to screen for falls or other nonmotor aspects of PD in these cases and provide early treatment for these symptoms,” they write.

“Intervening at the earliest stage of PD may provide the best chance for slowing disease progression and maintaining function. Clarification of the early course of PD with studies such as this may allow identification in time to change the course of disease.”

The analysis was supported by Stichting ParkinsonFonds. The Rotterdam Study is supported by the Erasmus MC University Medical Center and Erasmus University Rotterdam; the Netherlands Organization for Scientific Research; the Netherlands Organization for Health Research and Development; the Research Institute for Diseases in the Elderly; the Ministry of Education, Culture and Science; the Ministry of Health, Welfare and Sports; the European Commission; the Netherlands Genomics Initiative; and the Municipality of Rotterdam. The study authors have disclosed no relevant financial relationships. Dr Brown receives compensation for serving on the Fellowship Advisory Board for AbbVie Inc. Dr Tanner reports receiving grants from the Michael J Fox Foundation, the Parkinson’s Disease Foundation, the Department of Defense, Sage Bionetworks, and the National Institutes of Health; compensation for serving on Data Monitoring Committees for Biotie Therapeutics, Voyager Therapeutics; and Intec Pharma; and consulting fees from Neurocrine Biosciences, Adamas Therapeutics, and PhotoPharmics.

JAMA Neurol. Published online September 25, 2017. Abstract, Editorial

Follow Deborah Brauser on Twitter: @MedscapeDeb

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All Opioids Now Subject to REMS, FDA Says

All Opioids Now Subject to REMS, FDA Says

The US Food and Drug Administration (FDA) has made good on its promise to require that immediate-release (IR) opioids be subject to the same set of prescribing rules as extended-release formulations of the drugs.

In July, FDA Commissioner Scott Gottlieb, MD, put the public and manufacturers on notice that the agency would soon be putting all opioids on a level playing field. On September 28, Dr Gottlieb said the agency had now taken action and that 277 IR opioids would be subject to Risk Evaluation and Mitigation Strategy (REMS) requirements.

“This week, we issued letters notifying 74 manufacturers of IR opioid analgesics intended for use in the outpatient setting that their drugs will now be subject to a more stringent set of requirements under a Risk Evaluation and Mitigation Strategy,” said the FDA Commissioner in a blog post. “The REMS requires that training be made available to health care providers who prescribe IR opioids, including training on safe prescribing practices and consideration of nonopioid alternatives,” said Dr Gottlieb.

The FDA has asked manufacturers to extend the training offer to pharmacists, nurses, and any providers involved in pain management.

To offer the training, manufacturers have provided unrestricted grants to accredited continuing education providers for courses that have content that has been “outlined” by the FDA, said Dr Gottlieb. That “blueprint” of training content is being updated to cover principles on acute and chronic pain management; nonpharmacologic, opioid, and nonopioid pharmacologic pain therapies; information about the safe use of opioids; and basic information about addiction medicine and opioid use disorders.

The FDA said it is also seeking public comment on whether such training should be mandatory for prescribers.

Interested parties have until December 29 to submit comments to the agency.

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Medullary Thyroid Cancer Surgical Recommendations Often Ignored

Medullary Thyroid Cancer Surgical Recommendations Often Ignored

Only about a third of patients with medullary thyroid carcinoma (MTC) receive the recommended initial treatment of a total thyroidectomy in addition to central neck lymph-node dissection, despite recommendations in guidelines to combine the two to decrease the possibility of reoperative surgery.

“The low rate of adherence to American Thyroid Association (ATA) guidelines was one of the more puzzling findings of our study,” senior author Masha J Livhits, MD, of the section of endocrine surgery in the department of surgery at the University of California, Los Angeles (UCLA) David Geffen School of Medicine, told Medscape Medical News.

The results of the new study are published this week in JAMA Surgery by Eric J Kuo, MD, also of the department of surgery at UCLA David Geffen School of Medicine, and colleagues.

“The evidence for performance of central neck dissection is robust, [and] prior studies have shown that even in small medullary thyroid cancers less than 1 cm in size, the rate of lymph node metastasis is nearly 40%,” Dr Livhits noted.

“Therefore, the performance of [central neck] nodal dissection in medullary thyroid carcinoma is justified,” she stressed.

Dr Livhits ventured a couple of explanations for the low rates of adherence to the guidelines — one could simply be lack of awareness of the recommendations, she said. Or in some cases, it may be that the surgeon didn’t know the diagnosis was MTC until after the operation, because no preoperative biopsy was performed.

In an invited commentary accompanying the new study, Jessica E Gosnell, MD, and Quan-Yang Duh, MD, of the University of California, San Francisco department of surgery, noted that this latest work underscores the low adherence to ATA guidelines, as well as providing some key insights regarding reoperations.

Only 35% of Patients Had Central Neck Node Dissection at Time of Surgery

Even though only about 5% of thyroid cancer is medullary, this type is more aggressive; it also differs from other thyroid cancers in that patients have elevated calcitonin, for example.

The ATA guidelines for medullary thyroid carcinoma, first published in 2015, support the long-held recommendation of prophylactic central neck dissection with total thyroidectomy as standard treatment; however, population-level data on the practice has been lacking.

For the new research, Dr Kuo and colleagues conducted a retrospective analysis of data from the California Cancer Registry (CCR) and the Office of Statewide Health Planning and Development (OSHPD), identifying 609 patients with medullary thyroid carcinoma who were treated between January 1999 and December 2012 and had a minimum of 2 years postoperative follow-up.

The patients had a mean age at the time of diagnosis of 52.6 years and the mean tumor size was 2.8 cm, with extrathyroidal extension in 18.7% of patients.

Despite the ATA recommendation, only 35.5% (216 patients) had undergone central neck dissection at the time of their initial thyroidectomy.

Of the entire cohort, 99 required reoperation (16.3%), which is consistent with rates reported in the literature. The median time to reoperation was 6.4 months.

After adjustment for multiple factors, a leading risk factor for reoperation was the presence of lymph-node metastasis (hazard ratio [HR], 3.43).

Meanwhile, central as well as lateral neck dissection — which is indicated in the presence of lymph-node metastasis, was protective of the risk of reoperation (HR, 0.53).

“The performance of central and lateral neck dissection was associated with a decreased risk of reoperation, particularly for patients who were initially seen with regional disease,” the authors note.

But of interest, the ATA recommendation of central neck dissection, alone, with thyroidectomy was not significantly associated with a reduced risk of reoperation. However, Dr Livhits underscored the fact that this finding may have been the result of the study design.

“Our finding that central neck dissection alone was not protective of reoperation is likely a limitation of our data source,” she said. “We used an administrative data set that relies on procedure codes being accurately recorded. Codes for central neck dissection are less precise and prone to errors, which likely contributed to our inability to observe an effect in this group.”

Avoid Reoperation Due to Possibility of Complications

The 5-year disease-specific mortality rate for the entire cohort of patients was 13.5% (82 patients), and the strongest factors associated with this were: metastatic disease (HR, 21.08), regional disease (HR, 4.77), larger tumor size (HR, 2.83 for >2 cm to 4 cm and HR, 2.89 for >4 cm), and older age (HR, 1.36 per decade).

There was no significant association between reoperation and an increased risk of mortality; among the 99 patients who underwent reoperation, fewer than half, 45.5% (45), were disease-free at a median follow-up of 7.7 years.

The lack of an association between reoperation and mortality likely represents the selection of appropriate patients, Dr Livhits said.

“In our opinion, this finding indicates that selected patients who have recurrent medullary thyroid cancer, which is amenable to reoperation, still do well following a second surgery,” she noted.

“This supports reoperation when necessary in appropriately selected patients.”

She added that “prior studies have reported that patients whose calcitonin level (a tumor marker for medullary thyroid cancer) is not too high prior to reoperation and who did not have extensive lymph-node dissection during the initial surgery can be cured following reoperation.”

Nevertheless, measures to avoid reoperation in the first place are considered necessary out of concern for the array of potentially serious complications that can arise in a reoperation, particularly relating to the development of scar tissue in a site previously operated on, Dr Livhits explained.

“This makes dissection and identification of important structures more difficult.”

In such situations, the recurrent laryngeal nerve can be placed at risk, which can result in temporary or permanent vocal-cord paralysis, for example.

Also at risk are the parathyroid glands, which, if injured could compromise calcium levels, subsequently resulting in various cardiac, neurologic, and musculoskeletal symptoms.

Adherence to ATA Guidelines for Surgery for MTC Will Reduce Reoperations

Reasons for the relatively low rates of adherence to the ATA guidelines regarding central neck dissection could vary, Dr Livhits speculated.

“In some cases, the surgeon may have not known that the patient had medullary thyroid cancer until after the surgery — [for instance], if the diagnosis was not made on preoperative biopsy, but only made on examination of pathology following surgery,” she said.

“In other cases, it may be due to a lack of awareness of guidelines.”

Evidence in support of the ATA guidelines includes studies showing that central neck metastases are frequently present in medullary thyroid cancer even when not identifiable pre- or intra-operatively.

“It follows that not doing central neck dissection in these patients would leave residual micrometastases that would eventually become clinically significant,” Dr Livhits said.

In addition, other previous research, including a recent study (Ann Surg Oncol. 2015;22:1207–1213), meanwhile have shown fewer reoperations in association with adherence to the ATA guidelines.

In terms of the inclusion of lateral neck dissection, the ATA guidelines indicate that, in addition to the presence of lymph-node metastasis, if patients have very high calcitonin levels, “the likelihood of lateral neck metastasis is high enough to consider lateral neck dissection at the outset as well,” Dr Livhits explained.

“However, to say that lateral neck dissection should be performed routinely in the absence of abnormal lymph nodes seen on preoperative imaging is likely overreaching.”

Study Provides Several Important Lessons

In their commentary, Drs Gosnell and Duh say: “There are several important lessons from this population study of patients with medullary thyroid cancer.

“First, despite the recommendation for total thyroidectomy and bilateral central neck dissection in patients with clinically diagnosed medullary thyroid cancer, a fair proportion of affected patients are not getting these operations.

“Second, neck dissection performed at the initial operation may be protective, [and] third, while many patients with medullary thyroid cancer develop recurrent disease, reoperations are not associated with increased mortality.

“The potential benefits of proactive surgical treatment appear clear,” they state.

The overall message is that “even patients with recurrent and metastatic medullary thyroid cancer can be treated with repeated reoperations and still live full and active lives.” Because of this, it “is therefore critically important to minimize complications along their sometimes decades-long disease course.”
The study received partial support from the H & H Lee Research Program. The authors of the study and editorial had no relevant financial relationships.  

JAMA Surgery. Published September 27, 2017. Abstract, Editorial

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Majority of Clinicians Experience Verbal Abuse, Intimidation

Majority of Clinicians Experience Verbal Abuse, Intimidation

The workplace appears to be an occasionally toxic environment for healthcare providers, as a majority of those responding to a recent Medscape Medical News poll said they had been victims of a range of verbal and physical violence at the hands of patients, and, often, colleagues.

Another large majority said they had witnessed violence, and most respondents said they had been given only minimal training to respond to the onslaught, and that there were insufficient protocols in place to protect them.

The poll was conducted in late July, in the wake of the shooting death of Tracy Sin-Yee Tam, DO, a 32-year-old family physician at the Bronx-Lebanon Hospital Center in New York City. A disgruntled ex-employee — a physician — murdered Dr Tam and wounded a patient, two medical students, two residents, and a gastroenterology fellow, before killing himself.

Overall, 88% of the 2389 respondents to the poll — who included nurses, advanced practice nurses, physicians, pharmacists, and other providers — said they’d personally experienced verbal abuse, and 76% said they’d experienced intimidation. About two-fifths said they’d been victims of physical assault, and 30% had experienced sexual harassment. Respondents also reported having been stalked.

Ninety-two percent said they’d witnessed verbal abuse and 81% said they’d witnessed intimidation, while 55% said they’d seen a physical assault.

Most often, the perpetrator acted out because of altered mental state from a mental illness or substance abuse, said poll respondents. Sorina Simion-Rodgers, MD, a psychiatrist, said, “The assaults (both physical and verbal) as well as intimidation and threats that I experienced were not from severely ill mental patients or dementia patients, but rather from malingerers, personality disorders, substance abusers and families.”  She added, “We are told by administration that being abused, hurt or even disabled by an attack is ‘part of our job.'”

Susan Hicks, a pharmacist, said that “a patient who demanded a controlled drug” tried to harm her with a box cutter, but, “luckily, I was able to move fast enough to get away from the patient.” Hicks said she “also experienced verbal abuse from drug seekers and pseudoephedrine seekers.”

Some commenters said they had experienced or witnessed violence from patients — or families — who were just plain unhappy with the response they got from health providers. Overall, for instance, 38% said people were irked at long wait times, and 26% said the acting out was in response to receiving bad news.

“Some patients and/or their families become verbally abusive when they don’t agree with your diagnostic impressions and/or treatment plans, leading to a difficult situation,” said Emilio Gonzalez, MD, a rheumatologist.   

Seventeen percent said what they witnessed or experienced was a reaction to overcrowding, and a quarter said it was from a disgruntled employee. Overall, 29% of respondents cited “other” as the reason for the violence, which some commenters suggested was a stand-in category for employee-on-employee violence.

“I had to meet with the chief of police regarding threats of physical violence made against me by faculty in my own institution,” said Edward Klatt, MD, a pathologist. The administration “did nothing,” said Dr Klatt, adding, “Incivility sucks the life out of an institution. Everyone is adversely affected in some way.”

Nursing, Emergency Medicine Most Under Fire

Nurses and advanced practice nurses reported personally experiencing or witnessing physical assault more than physicians, pharmacists, or other healthcare providers. Half of all nurses said they were victims of an assault compared with 36% of physicians, 18% of pharmacists, and 24% of other providers. Nurses in emergency medicine settings reported the highest rates of assault — 77% said they’d experienced physical violence — followed closely by those in psychiatric settings.

Verbal abuse and intimidation of nurses was also higher in emergency medicine than in family medicine. Nurses in emergency medicine, psychiatry, and family medicine also reported much higher rates of sexual harassment — both experiencing it and witnessing it — than physician colleagues. Some 42% of psychiatrists, however, said they’d experienced sexual harassment — compared with 28% of emergency medicine doctors, for instance.

Emergency physicians and psychiatrists also experienced and witnessed more physical assault than colleagues in family medicine (25%) or internal medicine (29%). Some 68% of emergency physicians said they’d experienced an assault, and 99% said they’d witnessed violence.

Psychiatrists were more likely to report they’d been victims of stalking — 23%, compared with 13% of emergency medicine doctors and 9% of internists.

Sadly — but perhaps not surprisingly — the violence seems kept under wraps by victims.

About a third of psychiatrists and psychiatry nurses said they always reported violence they had experienced, but they seem to be the exception. Overall, only 18% of emergency nurses and 11% of emergency physicians said they always reported being victims of violence. Nearly 60% of emergency room nurses sometimes, rarely, or never filed a report.

Hospitals Cited as Unsupportive

Overall, the hospital was reported most often as the environment where violence was experienced or witnessed, cited by 85% of respondents. Physicians also reported violence in office and outpatient settings.

Almost 70% of the total respondents said they’d received no or minimal training in how to cope with workplace violence. Many commenters said they blamed administrators for not taking workplace violence — and bullying — seriously.

“I was violently physical[ly] assaulted in an outpatient mental health facility on March 16, 1998,” said Debra Riggs, RN, who added, “I have had severe and chronic [post-traumatic stress disorder] since that time.” Riggs said the facility’s CEO contacted her after her treatment, and that “he thought it funny that my colleagues wanted security in the workplace.” The nurse said that friends and coworkers ostracized her and that she received no support from colleagues or administrators.

Another RN, Denise Bleak, said she had experienced bullying. “I’ve been kicked in the chest, slugged in the mouth, hit on the head by an administrator (she stopped when I told her she was on camera), had a doctor throw a chart at me as a new RN in ICU.”  

“My message to all is always speak up, report, and learn to say loudly if it is a coworker, ‘stop it. I don’t like that.’ Being loud made me unpopular and kept me safe.”

Bleak said she believed that “there is no administrative safety culture (it is often fakery) and little peer support for square pegs in round holes.”

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