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Kamis, 01 Maret 2018

Nuts, Especially Tree Nuts, and Improved CRC Survival

The finding that eating nuts is associated with improved survival in patients with colorectal cancer (CRC) is making headlines again.

The finding comes from an observational study of patients with stage III colon cancer who were treated with surgery and adjuvant chemotherapy. For those patients who recalled eating two servings of nuts per week, disease-free survival (DFS) and overall survival (OS) were significantly extended compared to those who had not consumed any nuts.

Interestingly, the association was significant only for eating tree nuts, which include almonds, walnuts, hazelnuts, cashews, and pecans.

Peanuts are in the legume family, and although there was a trend toward improved outcomes with peanuts, it was not statistically significant.

The study was published online February 28 in the Journal of Clinical Oncology. It was previously presented in 2017 at the annual meeting of the American Society of Clinical Oncology, as reported at the time by Medscape Medical News.

ASCO President Daniel Hayes, MD, said at the time: “Basic healthy eating can often be overlooked during cancer treatment. This study shows that something as simple as eating tree nuts may make a difference to a patient’s long-term survival.”

Study Details

The study was conducted in 826 patients with stage III colon cancer who had taken part in the adjuvant chemotherapy CALGB 89803 (Alliance) clinical trial.

Patients completed a semiquantitative, 20-page food frequency questionnaire, and total nut intake was calculated as the weighted proportional summation of both tree nuts and peanuts.

After a median follow-up of 6.5 years, patients who consumed at least two 1-oz servings of any type of nuts per week had a 42% improvement in DFS (hazard ratio [HR], 0.58; P = .03) and a 57% improvement in OS (HR, of 0.43; P = .01).

“Further analysis of this cohort revealed that disease-free survival increased by 46% among the subgroup of nut consumers who ate tree nuts rather than peanuts [HR, 0.54; P = .04],” senior author Charles Fuchs, MD, director of Yale Cancer Center in New Haven, Connecticut, said in a statement.

OS was 53% longer in the same subgroup of tree nut consumers than in those who did not eat tree nuts (HR, 0.47; P = .04), the investigators observe.

What Is It in Nuts?

“The association of total nut intake with improved outcomes was maintained across other known or suspected risk factors for cancer recurrence and mortality,” the study authors report.

They note that nutrients in nuts, such as unsaturated fatty acids, fiber, vitamins, and minerals, may provide anticarcinogenic and anti-inflammatory properties that could favorably affect outcomes in CRC patients.

They also hypothesize that nuts may have beneficial effects on hyperinsulinemia and energy balance, thereby improving patient outcomes as well.

“What we found was that patients who regularly ate nuts had a significantly higher rate of cure, they had a lower risk of the cancer coming back, and a greater survival, and we found this really consistently throughout the study,” Fuchs said in an interview with the journal.

The authors caution that the findings from their observational study do not prove that nuts improve CRC outcomes; rather, they further support previous observations that a healthy diet and lifestyle can benefit patients with CRC.

“These findings are in keeping with several other observational studies that indicate that a slew of healthy behaviors — including increased physical activity, keeping a healthy weight, and lower intake of sugar and sweetened beverages — improve colon cancer outcomes,” lead author Temidayo Fadelu, MD, a postdoctoral fellow at Dana-Farber Cancer Institute in Boston, Massachusetts, said in a statement.

“The results highlight the importance of emphasizing dietary and lifestyle factors in colon cancer survivorship,” he added.

The study was supported by the National Cancer Institute of the National Institutes of Health, the International Tree Nut Council Nutrition Research and Education Foundation, and the Pharmacia & Upjohn Company, which is now Pfizer Oncology. Dr Fadelu has disclosed no relevant financial relationships. Dr Fuchs has a leadership role in CytomX Therapeutics and has served as a consultant or in an advisory role for Eli Lilly, Sanofi, Merck, Entrinsic Health, Five Prime Therapeutics, Agios, Gilead Sciences, Merrimack, Taiho Pharmaceutical, the KEW Group, and Genentech.

J Clin Oncol. Published online February 28, 2018. Abstract

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New Gene Variant Robustly Linked to Opioid Addiction

Researchers have identified a novel gene variant involved in opioid addiction, a finding that may aid efforts to develop novel pharmacologic approaches to the treatment of opioid dependence.

In a genome-wide association study, investigators found that a variant on chromosome 15 (rs12442138) near the repulsive guidance molecule A (RGMA) gene was associated with opioid dependence at a “genome-wide significant” level.

“We hope that this new biology that we identified will lead to new treatment strategies. Previously, there was little reason to focus on RGMA systems in developing opioid dependence treatments. Now there is,” senior author Joel Gelernter, MD, professor of psychiatry and director of the Division of Human Genetics in Psychiatry, Yale University, New Haven, Connecticut, told Medscape Medical News.

The study was published online January 11 in Biological Psychiatry.

Promising Lead

Opioid dependence is a genetically complex disorder that is influenced by complex environmental factors, making it tough to identify genetic factors that underlie the disorder, Gelernter and colleagues note in their article.

To tease out some of the genetic contributions to opioid dependence, they scanned the genomes of 3058 opioid-exposed European Americans, including 1290 who met DSM-IV criteria for opioid dependence.

They found that the rs12442183 variant near the RGMA gene had a “robust” association with opioid dependence. “If you have a certain RGMA variant, you’re more likely to have opioid dependence symptoms than if you have the alternative form,” Gelernter said.

“We believe this is a good new lead and hope it encourages novel pharmacological approaches to treating opioid dependence,” Gelernter told Medscape Medical News. He added that larger opioid dependence clinical samples are needed to replicate and extend the current findings.

This RGMA variant was also linked to opioid dependence in a group of African Americans, but the association was much weaker than in European Americans.

Prior studies have shown that the protein product of RGMA regulates cell death and nerve growth in the brain, findings that suggest how the gene might alter the brain’s response to opioids, the researchers point out.

In an analysis of brain tissue expression datasets, they further demonstrated a significant correlation between the expression of RGMA and the expression of four genes that have been shown to affect risk for other psychiatric disorders, including schizophrenia, Alzheimer’s disease, and autism.

“These RGMA coexpressed genes are critical to normal brain function, supporting the potential involvement of RGMA in related biological processes,” the researchers conclude.

“In the midst of an opioid crisis, it is timely to identify new genetic risk factors that contribute to addiction risk,” John Krystal, MD, chairman, Department of Psychiatry, Yale University School of Medicine, and editor of Biological Psychiatry, commented in a news release.

Biol Psychiatry. Published online January 11, 2018. Abstract

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Cancer 'Groundshot' Has Pragmatic Aims

A “cancer groundshot” could have a greater public health impact on global cancer outcomes in the next 10 years than any would-be innovations from high-tech moonshots in United States and other affluent countries, according to an essay published online February 28 in Lancet Oncology.

The term “groundshot” refers to using cost-effective and proven measures in the prevention and treatment of cancer — on a global scale. Currently, it is an idea in search of collaborators and commitments, say the essay authors, led by Bishal Gyawali, MD, from the Anticancer Fund, in Strombeek-Bever, Belgium, and an oncologist at the Civil Service Hospital, Kathmandu, Nepal.

The phrase was coined by Dr Gyawali in a late-2016 blog post in reaction to the hype generated by moonshot advocates.

“I’d rather support [an effort] that focuses on smoking and obesity reduction campaigns, promotes exercise and healthy diet, and encourages research that can be immediately applied to every global community. ‘Cancer groundshot’ is the term. Please feel free to use it,” he wrote on ecancer.org.

The groundshot is a “parallel” initiative with various moonshots in the United States, United Kingdom, and Canada and is not a competitor, write Dr Gyawali and his coauthors, Richard Sullivan, MD, PhD, from King’s College London, United Kingdom, and Christopher Booth, MD, from Queen’s University, Kingston, Ontario, Canada.

But they also say that the high-tech moonshot concept, with its emphasis on immunotherapies, big data, and precision oncology, is “not an effective strategy” globally.

“I like the idea of the cancer groundshot because there are already strategies that could be implemented with huge impact on some cancers,” said Jose Jeronimo, MD, chief technical officer, Global Coalition Against Cervical Cancer, Arlington, Virginia, who was asked to comment.

The essay authors cite cervical cancer as one such malignancy that is primed for a groundshot.

They explain that more than 85% of cervical cancer cases worldwide exist in low-income and middle-income countries, where most women present with advanced disease. In high-income countries, such patients would be offered the expensive monoclonal antibody bevacizumab (Avastin, Genentech/Roche) plus two chemotherapy regimens. In 2014, this combination, compared with chemotherapy alone, was shown to improve median overall survival in this setting (17.0 vs 13.3 months; P = .004).

A groundshot would not emphasize that approach to cervical cancer. Instead, funds and efforts would go to human papillomavirus vaccination and cancer screening. The vaccine “can prevent most cervical cancers,” and “screening can detect disease at an early stage at which it can still be successfully treated,” assert the authors.

Moonshot-like research projects in the United States and elsewhere focus on developing costly, high-tech targeted therapies, such as monoclonal antibodies, to improve overall survival — that’s a major goal, point out the essay authors.

Dr Jeronimo agreed that “expensive drugs” are no help to anyone who is not relatively affluent. “Those drugs are difficult to access in well-developed countries, and impossible to get in developing countries,” he observed.

In comments to Medscape Medical News, Dr Gyawali suggested the cancer groundshot is also a vision of what not to do.

For example, he said that 90% of all patients with HER2-positive breast cancer in low- and middle-income countries do not receive trastuzumab (Herceptin, Genentech/Roche) because of affordability. Yet, despite such deprivations, cancer clinics in some of those countries “have started to implement artificial intelligence (Watson for Oncology).” One of those places is India, as reported by Medscape Medical News.

The groundshot discourages “flowing with the hype of high-income countries” and encourages “judicial allocation of limited resources,” he said.

Pillars and Funding

Another pillar of a groundshot is drug “repurposing,” which would ideally involve countries of all wealth levels.

The authors explain that there is a need to test relatively inexpensive drugs, such as aspirin and metformin, which are already used or approved for other indications, in patients with cancer; evidence suggests efficacy. But drug companies have no incentive to test unpatented drugs. However, if experts from high-income countries, who have the technical know-how to run clinical trials, advised physicians from low- and middle-income countries, it could be accomplished.

A cancer groundshot would also “ensure access” to proven interventions, say the authors. They ask, Why spend more money on highly technical innovations in certain cancers that already have effective and established prevention, surgery, radiotherapy, and chemotherapy? Invest in what already works, they suggest.

Access to palliative care and effective pain relief is also a cornerstone of the groundshot.

The entire initiative requires more planning and work than moonshots; in fact, it represents radical change, the essayists state. “If the global oncology community is serious about improving cancer outcomes now, a revolution around the reality of cancer is needed,” they conclude.

Who would pay for all of this? Dr Gyawali believes that the money will come but only after a change in consciousness.

“Once the idea is acknowledged, funding wouldn’t be a problem. Once the sexy concepts of moonshots or artificial intelligence or precision oncology et cetera were introduced, there were billions of dollars pouring in from every direction,” he said.

The same applies to the groundshot, but with lesser amounts of money because there is no profit motive.

“If international not-for-profit organizations, local government policymakers, and philanthropist organizations/people can be convinced, we can take this idea forward to the implementation phase,” he said.

The essay authors and Dr Jeronimo have disclosed no relevant financial relationships. Dr Jeronimo’s organization, the Global Coalition Against Cervical Cancer, receives partial funding from BD Diagnostics and the Centers for Disease Control and Prevention.

Lancet Oncol. Published online February 28, 2018. Abstract

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Monitoring Sufficient for Moderate-Severity Cervical Lesions

Active monitoring, vs immediate treatment, of cervical intraepithelial neoplasia grade 2 (CIN2) may be justified in young women, according to a systematic review and meta-analysis published online February 27 in the BMJ.

“The results of our analysis show higher rates of regression and lower rates of progression of histologically confirmed CIN2 lesions than previously reported, particularly in women aged less than 30” and suggest that “[c]onservative management with active surveillance, instead of immediate local excision, is therefore justified in selected women, especially if further pregnancies are considered and compliance with surveillance is likely to be high (primum non nocere),” write Karoliina Tainio, MD, from the University of Helsinki and Helsinki University Hospital, Finland, and colleagues.

The investigators identified 36 studies that included 3160 women with histologically confirmed CIN2 who were not treated at diagnosis. All women were monitored for at least 3 months and had a diagnosis at the end of the study period.

The researchers included publications between January 1, 1973, and August 20, 2016. Rates of regression, persistence, and progression were evaluated as well as rates for nonadherence with active surveillance. Literature searches, data extraction, and risk of bias assessment were performed independently and in duplicate by two of the researchers, and heterogeneity between studies was assessed with the I² metric of inconsistency.

Overall, the investigators found that rates of regression were high: 46% at 12 months (13 studies; 300/628 women; 95% confidence interval [CI], 36% – 56%; I² = 81%) and 50% at 24 months (11 studies; 819/1470 women; 95% CI, 43% – 57%; I² = 77%).

Progression rates increased with time — they were as low as 5% at 3 months (three studies; 7/133 women; 95% CI, 2% – 10%; I² = 0%) and as high as 24% at 36 months (three studies; 105/370 women; 95% CI, 12% – 39%; I² = 87%). The pooled persistence rate was 47% at 3 months (three studies; 56/145 women; 95% CI, 16% – 79%; I² = 93%) and remained stable at approximately 30% for the remaining time points through 24 months.

The investigators also found, however, that 50% of the studies (18/36) met the criteria for high risk of bias, most often as a result of loss to follow-up. In addition, follow-up procedures varied greatly between studies with respect to colposcopic evaluation or histologic sampling.

The authors caution that the results should be interpreted with care given the substantial heterogeneity between studies as well as the possibility of lesion misclassification, a recognized problem in clinical practice.

“Although the risk of missing glandular or invasive disease and the risk of progression is relatively low, active surveillance should be offered only to women who would likely benefit from it,” the researchers conclude.

Reassuring Data, but Patient Selection Is Critical

“Although this meta-analysis might not have all the answers, it does provide the best information to date on likelihood of regression or progression after a diagnosis of CIN2,” writes Maggie Cruickshank, MBChB, MD, FRCOG, professor of obstetrics and gynecology, at the University of Aberdeen School of Medicine, United Kingdom, in an accompanying editorial.

Cruickshank suggests that the risk for progression to cancer may still be unacceptable for some and cautions that “data on the duration of ‘active surveillance’ was limited” and that there is still not “a clear definition of active surveillance in the context of CIN2.”

“Knowledge of the rates of regression from CIN2 are reassuring but they must be presented in a meaningful way alongside clear information about the effects of both surveillance and treatment, so women can make fully informed choices,” Cruickshank concludes.

Funding for this study was provided by the Sigrid Jusélius Fellowship, the British Society of Colposcopy Cervical Pathology Jordan/Singer Award, the Imperial College Healthcare Charity, Genesis Research Trust, the Imperial Healthcare NHS Trust National Institute for Health Research Biomedical Research Centre, the Academy of Finland, Competitive Research Funding of the Helsinki and Uusimaa Hospital District, the Jane and Aatos Erkko Foundation, the Sigrid Jusélius, and the Competitive Research Funding of the Helsinki and Uusimaa Hospital District. The authors and editorialist have disclosed no relevant financial relationships.

BMJ. Published online February 27, 2018. Full text, Editorial

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75% of Transgender Women Fail to Suppress Testosterone

Only one quarter of transgender women who received spironolactone for testosterone suppression achieved testosterone levels considered within the usual female range, according to results of a new single-center, cross-sectional study.

Patients in the other three quartiles did not achieve testosterone levels considered to be within the usual female physiologic range (serum testosterone < 50 ng/dL), as indicated by the Endocrine Society guidelines for transgender women.

Published in the February issue of Endocrine Practice (2018;24:135-142), this is the first study to show that the US medical regimen of spironolactone (100–200 mg/day) with estradiol can lower testosterone levels in some transgender women to within the usual female range, in an effort to align physical appearance with gender identity.

The authors, led by Jennifer J Liang, MS, from Boston University School of Medicine, Massachusetts, write that “identification of reasons why certain patients have better testosterone suppression could help improve antiandrogen therapy and allow for targeted interventions to advance the US medical regimen for transgender women.”

Efficacy of Testosterone Suppression Has Not Been Evaluated

A goal of transgender medical intervention for many transgender individuals is to align physical appearance with gender identity. The strategy for transgender women (male to female) includes medication and/or surgery to decrease testosterone levels to the female range. Most transgender women depend on medical treatment alone to lower their testosterone levels, and in the United States, spironolactone is the primary adjunctive antiandrogen used for this purpose.

Hormone therapy in transgender adults is considered safe, however, the efficacy of treatment for testosterone suppression with medical treatment alone has not been evaluated. This study aimed to assess testosterone suppression using a regimen of spironolactone and estrogens.

Testosterone and estradiol levels were taken from the electronic medical records of 98 transgender women treated with oral spironolactone and estrogen at the endocrinology clinic at Boston Medical Center.

The therapeutic goal was to achieve serum testosterone levels below 100 ng/dL without estradiol becoming supra-physiologic (maintaining estradiol levels below 200 pg/mL). Both estrogen and spironolactone were titrated to achieve the goal.

Testosterone levels from therapy initiation through 3.5 years were recorded and patient data were aggregated into quartiles based on average steady-state testosterone levels. Quartile one represented the best testosterone suppression and quartile four represented the worst.

Patients were also aggregated into normal weight, overweight, and obese based on their average body mass index (BMI) across the study. People with normal BMI started at significantly higher testosterone levels than obese individuals.

Participants were also grouped according to their average spironolactone dosage and age. Estradiol levels were assessed relative to testosterone.

Is Success Down to Adherence?

Overall, the median testosterone levels of transgender women declined from 385 ng/dL at the initial visit to consistently under 130 ng/dL by 12 months.

Baseline average testosterone level was not a useful predictor of patient response to testosterone suppression strategies, the researchers note. This suggests that testosterone level at the initial clinical visit is not a reliable indicator of whether the patient will achieve success with treatment.

The highest suppression quartile achieved a mean testosterone level of 27 ng/dL. The second highest quartile did not achieve testosterone levels in the female range, but remained below the male range almost all the time. The least suppressed quartile was unable to achieve any significant testosterone suppression.

Participants with normal BMI showed the steepest decline in testosterone over the 9 months (average time to reach steady state) but did not reach the female range overall.

Those with BMI in the obese range at baseline showed the least steep decline but seemed able to achieve the lowest levels of testosterone overall, note the authors. By 18 months, there was significant overlap among all categories.

The researchers add that age was not a useful predictor of success with testosterone suppression. Patients in all spironolactone dosage quartiles followed a similar pattern of decline in mean testosterone. Serum estradiol levels did not change over time or correlate with estradiol dose administered.

Discussing the findings, Liang and colleagues note that, of participants in the quartile unable to achieve any significant testosterone suppression, they may have had difficulty adhering to treatment or had a different physiologic response to treatment than others.

“On the other hand, patients who were able to achieve high levels of suppression may have adhered stringently to their treatment or had a robust response based on physiology.”

Endocr Pract. 2018;24:135-142. Abstract

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Diesel Exhaust Linked to ALS

Occupational exposure to diesel exhaust is associated with a higher risk for amyotrophic lateral sclerosis (ALS) among men, new research indicates.

Truck drivers, service station attendants, and others with the highest level of exposure to diesel exhaust while on the job at least 10 years in the past were 46% more likely to be diagnosed with ALS than those with no exposure, the study found.

“It’s important to know what your patients are being exposed to when you’re trying to decipher how they may have acquired the disorder that they have, in this case ALS,” lead author, Aisha Dickerson, PhD, a postdoctoral research fellow, departments of epidemiology and environmental health, Harvard TH Chan School of Public Health, Boston, Massachusetts, told Medscape Medical News.

Dr Aisha Dickerson

The research will be presented April 22 at the upcoming American Academy of Neurology (AAN) 2018 Annual Meeting in Los Angeles, California.

From the Danish National Patient Registry, Dickerson and her colleagues identified 1639 people with ALS, mean age 56 years. For each of these cases, they selected 100 age- and sex-matched controls from the Danish Central Person Registry.

The researchers obtained employment history for each person from the nationwide Danish Pension Fund, which has been collecting employment data since 1964.

They did a separate analysis for jobs held at least 5 years before the ALS diagnoses (index date), and another only for jobs held at least 10 years before the index date.

As Dickerson explained, neurodegenerative disorders such as ALS have a very long induction period — the time between when a person is exposed and when symptoms actually develop.

Exposure Matrix

They created a job exposure matrix to estimate exposure to diesel exhaust. Such a matrix is typically created by an occupational medicine expert using air quality measures and blood or urine samples of people who work in the relevant industries, explained Dickerson.

This allows researchers to estimate the average level of exposure for someone who works within that industry.

Factors involved in calculating cumulative diesel exhaust exposure included the duration of employment as well as the probability of exposure and level of exposure, said Dickerson.

Workers in certain occupations, such as truck drivers, bus drivers, and some police officers, are more likely to be exposed to diesel fuel. “Most cars that are driven long distances have diesel engines, especially in Europe,” said Dickerson, adding that diesel is more fuel efficient than other types of gasoline.

“In Europe, diesel engines are still a lot more popular than they are in the US.”

Gas station attendants, construction workers, agricultural workers, and machinists might also be exposed to diesel exhaust.

For this study, researchers excluded those older than 25 years in 1964, the year Denmark started collecting occupational data. Including those who had worked for any length of time before this might have caused “a lot of misclassification,” especially since regulations on exposure were less stringent, said Dickerson.

Researchers adjusted for socioeconomic status and place of residence, factors that might affect ALS risk.

The study showed that men with any occupational exposure to diesel exhaust at least 10 years before inclusion in the study were 20% more likely to have ALS than men with no exposure during the same time period (adjusted odds ratio [OR], 1.20; 95% confidence interval [CI], 1.05 – 1.38).

Researchers also looked at exposure intensity. They considered anyone with less than a 50% likelihood of exposure not to have been exposed.

Men with greater than a 50% probability of being exposed to diesel exhaust were 41% more likely to develop ALS than unexposed men (OR, 1.41).

When researchers divided participants into four groups based on exposure to diesel exhaust, they found that for both the 5-year and 10-year lag periods, men in the highest quartile of exposure had higher odds of ALS compared with those with no exposure (adjusted ORs of 1.34 [95% CI, 1.06 – 1.69] and 1.46 [95% CI, 1.143 – 1.86], respectively).

No Link in Women

There was no association between diesel exhaust exposure and ALS among women. Dickerson pointed out that women are less likely to have been in jobs that exposed them to diesel fuel.

“Keep in mind that this data is from the 1960s. Back in the 1960s, you would not expect a woman to have worked, much less in a blue collar occupation where she would have been constantly exposed to diesel exhaust.”

It’s not clear from this study what element of diesel exhaust might affect ALS risk. Dickerson noted that the exhaust contains a number of components that could cause genetic mutations.

“And just being exposed to diesel exhaust can cause inflammation and subsequent oxidative stress in the body, and that stress can impact neurodegeneration.”

Stephen Goutman, MD, director, ALS Clinic, and assistant professor of neurology, Neuromuscular Program, University of Michigan, Ann Arbor, told Medscape Medical News that some constituents of diesel exhaust, including formaldehyde and benzene, have raised concern about their possible link to ALS.

“It may not be the diesel exhaust itself, but instead the subchemicals within the diesel exhaust.”

He suspects that the burning of the fuel releases such chemicals and that this “is driving the risk” for ALS.

Looking at the role of environmental factors is going in the right direction because ALS risk involves more than just genetics, said Goutman. “We have not been able to clearly link a genetic cause to every case of ALS.”

This is not the first study to link occupational exposure to diesel exhaust with ALS. But it’s strengthened by use of the “vast database” of prospectively collected surveillance data from Danish registries, said Dickerson.

“There is no risk of anyone forgetting where they worked, or how long they worked somewhere, which might be an issue with other studies.”

While diesel fuel is used more frequently in Europe, it’s not clear whether this affects the incidence of ALS outside the workplace, said Dickerson.

“We are only looking at occupational exposure in this study, but the definite next step for our research would be to look at diesel exhaust exposure via ambient air concentrations in the general population.”

Policy Changes?

She said she hopes that highlighting the impact of diesel exhaust exposure on ALS risk will influence government policies. She pointed to what happened when lead was proven to be harmful.

“We used to have leaded gasoline, but when we saw what it was doing to children and even adults, people implemented policies to take the lead out of the gasoline.”

Researchers are looking at the impact of diesel exhaust exposure on other neurodegenerative disorders, including Parkinson’s disease and Alzheimer’s disease, said Dickerson.

Commenting further on the study, Goutman said it was “definitely” bolstered by using registry data “that captures all individuals with ALS and compares that to the control population in their registry.”

The study looked at 5- and 10-year lags, but researchers aren’t certain about the exact time frame of exposure that is most critical for developing ALS, said Goutman.

“It’s not likely within the last week or month, but at some point in the past — but is that 5 years ago, 10 years ago, 15 or 20 years ago? We don’t know which of those time frames makes one most susceptible to the disease.”

Whatever time frame is most important, the current hypothesis is that this environmental exposure in someone who is genetically susceptible may set in motion the oxidative stress and epigenetic changes that may then “drive that person over the edge to then go on to develop ALS,” said Goutman.

The challenge is to identify “meaningful” past exposures and to understand “what kinds of mechanistic changes these exposures are leading to,” he said.

“If we can identify clear exposure-disease associations, if we can get to that stage where we can find these mechanisms and therapeutic targets, I think that will take us to the next step in advancing treatments and cures for the disease.”

The study was supported by the National Institute of Environmental Health Sciences. Dickerson was supported in part by a National Institutes of Health training grant. Dickerson and Goutman have disclosed no relevant financial relationships.

American Academy of Neurology (AAN) 2018 Annual Meeting. Abstract S4.005. To be presented April 22, 2018.

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Pediatrician Arrested, Accused of Giving Kids Partial Vaccines

Orlando, Florida, pediatrician Ishrat Sohail, MD, was arrested last week on charges of Medicaid fraud, accused of improperly administering vaccines provided through the Vaccines for Children (VFC) Program, according to the Florida Department of Health (FDOH).

According to an FDOH press release, Dr Sohail had allegedly been administering VFC vaccines intended for those on Medicaid and the uninsured to patients covered under private insurance, and then billing the private insurer.

Additionally, the statement said, an investigation found that she was administering partial vaccine doses to patients while billing for the full dose. Because partial doses may not sufficiently protect children from disease, the FDOH has asked patients who received vaccines from Dr Sohail between 2016 and 2018 to consider revaccination with another provider. The department estimates that 500 children may have been affected.

Emergency Order Suspends License

According to the statement, State Surgeon General Celeste Philip, MD, MPH, has issued an emergency order suspending Dr Sohail’s license to practice medicine in Florida.

The department’s statement added, “There is also the possibility that Dr. Sohail did not follow best practices in maintaining the sterility of the vaccines she administered,” and the department urged any parent whose child was vaccinated by Dr Sohail and has had an adverse reaction at the injection site to contact the Orange County branch of the FDOH. The vaccines reportedly included those used to prevent hepatitis A, human papillomavirus (HPV), and whooping cough.

Kent Donahue, public information officer with the FDOH Orange County, told Medscape Medical News that as of Tuesday morning no calls reporting vaccine complications related to this case had come in. As to whether revaccination of children could result in overvaccination, he said the department routinely cross-checks databases to determine when a child received vaccinations over a lifetime to protect against overlap.

The investigation was conducted jointly with the FDOH and the Office of the Attorney General’s Medicaid Fraud Control Unit.

The statement gave this account of events leading to the arrest: In 2016, investigators found in a site visit that Dr Sohail had administered two vials of VFC vaccines to children covered by private insurance and then billed the private insurer. She was suspended from the VFC program for 2 months and then put on a corrective action plan under which she had limited access to the vaccines. In late January of 2018, investigators raided her office and found partially used single-dose vaccine vials in the refrigerator.

According to WKMG News 6, Dr Sohail posted bond and was released February 23 from the Seminole County jail, refusing to answer a reporter’s questions.

Dr Sohail also could not be reached for comment this past Monday.

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