Monday, October 2, 2023
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In 2016, the Zika virus spread throughout the Americas, nearly 70 years after it was first isolated.[1] In February, the World Health Organization declared Zika-linked birth defects, such as microcephaly, to be a public health emergency.[2] As travel-related transmission of the virus increased, sexual transmission of the virus was seen in Texas in February, and the first male-to-male transmission in the United States was seen in April.[3,4] Gaining the requested funding for Zika-related research and surveillance from the US Congress was difficult during this election year.[5-10] Congress finally approved funding in September.[11] The first infant with Zika-related microcephaly was born in Florida in June, and in July the first cases of locally acquired Zika infection were reported in the United States.[12] In August, 10 new locally transmitted Zika cases in Florida prompted a travel warning to the Miami area.[13] Also in August, the United States declared a public health emergency in Puerto Rico, the hardest hit US territory.[14] On November 3, the Centers for Disease Control and Prevention (CDC) defined congenital Zika syndrome, a recognizable pattern of congenital anomalies in infants that includes severe microcephaly and ocular findings.[15] As of November 9, over 4000 cases of Zika infection had been reported in the United States. Of those, 139 were locally acquired, all in Florida.[16] In one small piece of good news, fears of Zika during the Olympics in Brazil proved to be overblown.[17,18] On November 28, the Texas Department of State Health Services announced the first case of a person infected with the Zika virus, likely spread by a bite from a mosquito in the state, making it the first reported instance of local Zika transmission in the United States outside of Florida.[19]
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After one of the most stressful campaigns in recent memory,[20] the 2016 election in the United States this November resulted in what could be a big shift for healthcare. President-elect Donald Trump has promised to repeal the Affordable Care Act (ACA), also known as Obamacare,[21,22] although recent reports suggest that Trump is stepping back from that campaign promise.[23,24] On the same ballot, Colorado became the sixth state to allow physician-assisted suicide, and seven states legalized recreational or medical marijuana.[25]
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The CDC in March issued final recommendations for prescribing opioids for chronic pain to combat an epidemic of overdoses that claims 40 lives a day.[26] "The prescription overdose epidemic is doctor-driven," CDC Director Tom Frieden, MD, MPH, said. "It can be reversed in part by doctors' actions." Earlier in the year, the US Food and Drug Administration (FDA) had announced sweeping changes to its opioid policies from a regulatory point of view.[27] And in April, the federal government released a National Pain Strategy, the first coordinated plan for reducing the burden of chronic pain.[28] Key elements include education and care by providers, as well as prevention.
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Final regulations for the Medicare Accountability and CHIP Reauthorization Act (MACRA), which replaced the sustainable growth rate formula for setting Medicare reimbursement, were released in October. More than 50% of physicians were excluded from a possible 2019 penalty because of their low volume of Medicare patients. The American Medical Association (AMA) and other medical societies have given MACRA a cautious thumbs-up so far.[29] Later that same month, the Centers for Medicare & Medicaid Services (CMS) announced some new payment arrangements that will qualify as advanced alternative payment models in the agency's Quality Payment Program, starting in the 2018 performance year. Physicians and other eligible clinicians who receive a certain percentage of revenue from advanced alternative payment models are exempt from the requirements and penalties of the Merit-Based Incentive Payment System and are eligible to receive 5% annual bonuses for 5 years, beginning in 2019.[30] In a previous Medscape survey almost 4 in 10 physicians in solo and small group practices predicted an exodus from Medicare because of the program's new payment plan and its punishing penalties.[31]
This year, the cost of EpiPen was reported to have increased from $100 in 2007 to $600 or more. The maker of EpiPen, Mylan, said that with more people buying higher-deductible health plans, they're more often paying for drugs that may have been covered before.[32] By August, Mylan said it would reduce the out-of-pocket cost for EpiPen through the use of a savings card.[33] Soon after, the company announced that it would launch a generic EpiPen at half the price of the original, despite it still being under patent protection.[34] About 20 class action lawsuits have been filed against Mylan because of its pricing of EpiPen. During a hearing of the House Oversight and Government Reform Committee in September, Mylan CEO Heather Bresch was repeatedly asked to explain the price increase, but she did not give a direct answer.[35] In a recent Securities and Exchange Commission (SEC) filing, Mylan revealed that two federal agencies — the SEC and the US Department of Justice — are investigating the company and that its premises had been searched, according to the Associated Press.[36]
Mylan currently has about 94% market share in the United States.[37] An alternative to EpiPen called Auvi-Q will be reintroduced to the market in 2017, its manufacturer Kaléo said. The autoinjector was subject to a major US recall in October 2015 because the device may not have delivered enough medication to someone with a severe reaction. Kaléo did not say how much Auvi-Q would cost but said it is committed to affordability, according to Reuters.[38]
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In his State of the Union address this past January, President Barack Obama announced a national initiative to find a cure for cancer, an ambitious "moonshot" that Vice President Joe Biden will direct in the remaining months of the administration.[39] The following month, the president asked Congress for $1 billion to fund the initiative.[40] The money would go to a variety of research initiatives over several years, but some experts questioned whether $1 billion would be enough. All of the major US cancer societies commended the speech and emphasized the progress being made in cancer research. American Cancer Society Chief Medical Officer Otis Brawley, MD, described the moonshot as "a galvanizing call for a renewed effort to find new tools to fight cancer."[41] In a Medscape poll soon after the initiative was announced, 60% of Medscape's readers said they support the initiative compared with 19% who said they don't and 21% who said they'd like to learn more.[42]
A second huge cancer research project is also shooting for the moon. On January 11, Patrick Soon-Shiong, MD, founder and CEO of the biotech firm NantWorks, laid out provocative plans for the launch of the National Immunotherapy Coalition, which will form the basis of Cancer MoonShot 2020.[43]
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Under new rules proposed in January by the International Committee of Medical Journal Editors (ICMJE), authors will have to agree to share clinical trial data for their manuscripts to be considered for publication. The move is intended to benefit patients, investigators, sponsors, and society. However, reactions from the community have been mixed.[44] The same day, in response to a study on colon cancer, the editor of the New England Journal of Medicine (NEJM), Jeffrey M. Drazen, MD (above), and the journal's deputy editor, Dan L. Longo, MD, expressed concern in an editorial that the system will be taken over by what some researchers have characterized as "research parasites."[45]
Soon after, Dr Drazen issued a new letter clarifying the NEJM's position. When the proper systems are in place, NEJM will require authors to make available the data that underlie the reported results of their work within 6 months after publication. This time, he did not include the word "parasites," saying only that in talking with clinical researchers about the proposal by the ICMJE, "Some of them spoke pejoratively in describing data scientists who analyze the data of others."[46] An NEJM spokesperson told Medscape in November that "Dr Drazen is a member of the ICMJE, which concluded an open comment period on this proposal in April. While we await ICMJE's final recommendations, NEJM remains committed to responsible data sharing in the setting of clinical trials."
According to an analysis published online in February in the BMJ, leading academic research centers are doing a poor and variable job of disseminating clinical trial results, with just 29% of completed trials at 51 major research centers being published 2 years after completion and a mere 13% having submitted their results to ClinicalTrials.gov. That is leading to serious information gaps and ethical lapses, researchers say.[47]
In August, the authors of four perspective articles published online in NEJM agreed that sharing patient-level clinical trial data will advance medicine, but they disagreed on the best guidelines for sharing responsibly and effectively.[48]
And finally, a new report shows that results of nearly half of all clinical trials conducted in the last decade by big drug companies have not been published, according to an analysis of data from TrialsTracker. This online tool identifies trials from ClinicalTrials.gov that haven't published results 2 years after the end of the trial.[49]
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A participant in the phase 1 trial of an investigational analgesic medication died on January 17. This individual and five other previously healthy volunteers were hospitalized at the University Hospital of Rennes in France after developing serious neurologic problems. The trial was examining a molecule, Bia 10-2474, for the treatment of motor disorders, neurodegenerative disorders, and anxiety disorders. This type of incident was totally "unprecedented" in France, the country's health minister said at the time.[50] About 2 weeks later, France's national drug safety agency released information showing that all patients in the high-dose group began taking that dose — 50 mg/day — at the same time, on Wednesday, January 6. This is against European Medicines Agency (EMA) recommendations governing phase 1 trials.[51] In May, the EMA launched a major review of guidelines for the conduct of phase 1 clinical trials, with an eye toward making them safer.[52]
In August, FDA officials released a statement that similar drugs being studied in the United States do not pose a similar safety risk, saying that Bia 10-2474 exhibited a "unique toxicity" that does not extend to other drugs in the class.[53] More details about the patients in the trial were published November 3 in the NEJM. The article describes the doses and timing, as well as more specific information about the severe neurologic adverse effects.[54]
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Two similar randomized controlled trials in patients with late-stage cancer suggest that a single high dose of the psychedelic drug psilocybin has rapid, clinically significant, and lasting effects on mood and anxiety, in findings that may be a therapeutic game-changer for psychiatry. The studies were published online December 1 in the Journal of Psychopharmacology. In one study, 83% of patients responded to psilocybin, and the results were durable at 6 months. In the second study, 92% of patients in the high-dose group showed a clinically significant response, with about 80% still responding at 6 months. A number of accompanying editorials and commentaries from experts in the field read like a "who's who" of US and European psychiatry. Experts generally praised the studies — describing them as "well-designed" and "methodologically rigorous" — and believe the findings may usher in an exciting new era of pharmacologic treatment in psychiatry. Many noted the replication of the main outcomes across the two study sites provides confidence that the findings are robust. However, some experts pointed out that while the study investigators tried to blind patients and personnel to the treatment assignment, it's unclear how effective blinding procedures actually were. Continued research was recommended.[55]
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The water in Flint, Michigan, began to be contaminated with lead after the city switched its water source from treated water from Lake Huron and the Detroit River to untreated water from the Flint River to save money. The harsher water from the river caused corrosion of the city's lead pipes, leading to lead leaching into the water supply. On January 16, President Barack Obama declared Flint to be in a federal state of emergency, which allowed federal aid from the Federal Emergency Management Agency and the Department of Homeland Security to supplement state and local efforts.[56]
Soon after, a physician whose warnings about high blood lead levels in children were initially dismissed, Mona Hanna-Attisha, MD, MPH, was appointed to head a multidisciplinary task force that seeks to blunt the harm done to children there. The Pediatric Public Health Initiative focuses on lead's neurotoxic effects on young children, including lower IQ, developmental delays, and behavioral issues, such as hyperactivity and even criminality. The team, roughly 30 strong, will include experts in pediatrics, child development, psychology, epidemiology, nutrition, toxicology, and education. "If we don't do something now to build this model public health program, we will see lifelong consequences," Dr Hanna-Attisha told Medscape Medical News at the time.[57]
In February, the FBI joined a US criminal investigation into Flint's water contamination crisis, a spokeswoman for the US Attorney's Office in Detroit said, to determine whether any federal laws were broken.[58] Four employees — one from the City of Flint, two from the Michigan Department of Environmental Quality (MDEQ), and one from the Environmental Protection Agency — resigned over the crisis, and one separate MDEQ staff member was fired. Criminal charges have since been filed against at least nine people.[59]
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In February, the first uterus transplant in the United States took place in a 26-year-old woman, identified as "Lindsey," at the Cleveland Clinic in Ohio.[60] The team had been working toward it since announcing their protocol the previous year.[61] However, in early March, the patient had to have the uterus removed after what turned out to be a yeast infection caused complications.[62,63] The Cleveland Clinic said at the time that the uterus transplant study, of which Lindsey was a part, is still ongoing.
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In February, the United Kingdom became the first country in the world to allow gene editing of human embryos. The research license does not allow the embryos to develop into infants, but in the future it is hoped that genetically modifying human embryos could lead to cures for some inherited genetic conditions.[64] One researcher plans to carry out her experiments using new gene-editing technology called CRISPR-Cas9, which can enable scientists to find and change or replace any targeted gene, strategically editing out specific stretches of DNA. The technology is the subject of fierce international debate amid fears it could be used to create designer babies.[65] The possibility for mistakes is also a huge concern, and there are still questions about the ability to assess a mutated embryo. "If a mosaic creeps in, you could be misled if you don't detect one of the edited or one of the unedited blastomeres," another researcher has said.[66]
The inner workings of CRISPR 2.0, including the new Cpf1 "scissors" that can cut DNA in a variety of patterns, were described at the European Society of Gene and Cell Therapy 2016 Annual Congress. Unlike previous CRISPR scissors, which cut DNA in a straight line, the new ones can cut in a staggered pattern, increasing precision, which could have a huge effect on the development of treatments for diseases. However, some scientists still worry about unintended and undetected "off-target" DNA alterations.[67] In March, the five scientists (above) that made foundational contributions to CRISPR were awarded the 2016 Alpert Prize. Their seminal work was published in Science in 2007.[68]
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In April, a healthy baby boy was born free of the mitochondrial disease that his mother carries, after the nucleus from her oocyte was transferred to an enucleated donor oocyte that was then fertilized with his father's sperm. In what has been called a "three-parent" mitochondrial manipulation technology (MMT), the team that performed the nuclear transfer intervention was led by John Zhang, MD, PhD, medical director and founder of New Hope Fertility.[69] Details about the infant born with the help of spindle nuclear transfer were revealed in October during a late-breaking session at the American Society for Reproductive Medicine 2016 Scientific Congress. Reactions ranged from dismay to admiration.[70]
The intervention was performed in Mexico; an FDA panel concluded in February 2014 that more data are needed before the procedure can be conducted in the United States.[71,72] This is in contrast to a decision by lawmakers in the United Kingdom, who voted last year to allow MMT to go forward,[73] and with a conclusion from the Institute of Medicine in February 2016 that MMT is "ethically permissible."[74]
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The controversial MOC program continued to make the news this year as changes were made at various levels. In March, the American Board of Internal Medicine (ABIM) said it has begun to study switching to an open-book exam for its MOC program.[75] In April, Oklahoma became the first state to enact a law aiming to remove MOC as a requirement for physicians to obtain a license, get hired and paid, or secure hospital admitting privileges.[76] By May, four states had enacted laws seeking to limit the use of MOC as a physician credential, and a similar measure has surfaced in another. State medical societies that operate under the umbrella of the AMA lobbied hard for the legislation. However, some of the credit for the anti-MOC legislation goes to the Association of American Physicians and Surgeons, a splinter group that views itself as the anti-AMA.[77] Also in May, the ABIM announced that it will allow its diplomates to test out of a high-stakes exam every 10 years for MOC by passing more frequent, but shorter, online exams beginning in 2018.[78] That same month, the American Board of Radiology (ABR) also announced that it plans to eliminate the requirement that radiologists take an examination every 10 years in order to maintain their board certification. In the second half of 2018, the ABR will pilot a continuous testing approach that could replace the 10-year exam, and if all goes well, the new system will be rolled out to all ABR diplomates "as early as mid-2019," the board said.[79]
For diplomates of the American Board of Obstetricians and Gynecology, the MOC exam will likely become optional for most of those licensed in the specialty, according to the board's incoming executive director. Under a 2-year pilot program, the group proposes an assessment three times a year for 6 years instead of an assessment done in year 6.[80]
At the American Academy of Family Physicians 2016 Congress of Delegates in September, the majority of delegates chose not to demand the end of the mandatory MOC exam conducted every 10 years by the American Board of Family Medicine.[81]
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Two conflicting articles provide more ammunition in the debate about calcium supplementation and heart health. First, 10-year follow-up from the Multi-Ethnic Study of Atherosclerosis (MESA) showed no excess cardiovascular (CV) risk with dietary calcium intake but suggested that calcium supplements may be associated with a higher risk for coronary artery calcification. The study was published online October 11 in the Journal of the American Heart Association.[82] Second, a new joint clinical guideline from the National Osteoporosis Foundation and the American Society for Preventive Cardiology published online October 24 in the Annals of Internal Medicine stated that both dietary and supplemental calcium are safe for CV health when consumed in recommended amounts. The recommendation applies to calcium consumed alone or with vitamin D that does not exceed the National Academy of Medicine's tolerable upper intake limit of 2000 to 2500 mg/day.[83] In a video commentary published on Medscape, JoAnn Manson, MD, DrPH, Harvard Medical School, noted that an important principle is that more is not necessarily better, a point echoed in an accompanying editorial.[84] In addition, dietary calcium should be recommended over supplements.
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The FDA in September granted accelerated approval to eteplirsen injection (Exondys 51, Sarepta Therapeutics), the first drug approved to treat patients with Duchenne muscular dystrophy (DMD).[85] The road to approval for eteplirsen was rocky. In late April, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee concluded that studies of eteplirsen failed to provide persuasive evidence that the drug is effective in DMD.[86] Some are concerned about the possible role that strong patient advocacy played in the approval, raising the question of whether all a drug company needs to do to win approval is demonstrate a slight difference in a laboratory test and activate the patient community, according to a JAMA viewpoint article. Others are glad to have the option but point out that discretion will be needed because of the drug's planned high cost. Sarepta has said it will charge $300,000 a year for eteplirsen.[87]
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Medical error is the third leading cause of death in the United States, after heart disease and cancer, according to findings published in the BMJ in May. The researchers examined four studies that analyzed data on medical death rates from 2000 to 2008. Then, using hospital admission rates from 2013, they extrapolated that, based on 35,416,020 hospitalizations, 251,454 deaths stemmed from a medical error. That number of deaths translates to 9.5% of all deaths each year in the United States — and puts medical error above the previous third-leading cause, respiratory disease.[88] Physicians and other clinicians who commented on the article predominantly disagreed with the study's finding, as described in a "Physicians Are Talking About" article published later that month on Medscape.[89] In fact, in a June Medscape poll, 51% of respondents said they do not think medical errors are the third leading cause of death in the United States compared with 31% who do and 18% who are uncertain. For physician respondents, those percentages were 66%, 18%, and 15%, respectively. Regarding other issues, 74% of overall respondents said the way the authors defined medical error was much too broad or somewhat too broad vs 13% who said it was accurate, 3% who called it somewhat or much too narrow, and 5% who were uncertain.[90] In July, two physicians called for the BMJ to retract the study, but the journal said a retraction was not warranted.[91]
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In September, the FDA approved Medtronic's MiniMed 670G hybrid closed-loop insulin delivery system, the first device that automatically monitors blood glucose and administers appropriate basal insulin doses, for patients aged 14 years and older with type 1 diabetes. Because the device responds to both low and high blood glucose levels — the current Medtronic system corrects only lows — it is being called the first "artificial pancreas." However, because patients still need to enter information about anticipated meals and request the device to deliver bolus insulin doses, it is called a "hybrid" rather than a fully closed-loop system.[92] The FDA approval was based on pivotal trial data on 124 patients with type 1 diabetes aged 14 to 75 years showing that when they wore the 670G for 3 months, it produced reductions of both hypoglycemia and hyperglycemia with less glycemic variability compared with baseline data.[93] In a poll of Medscape's members the following month, 87% of respondents said they think the approval represents a major advance in type 1 diabetes management. More than a third of respondents (39%) said they think the device is likely to be adopted by up to 10% of their patients. Fifteen percent said that 50% or more of their patients could use it. A majority of respondents (56%) said they would be comfortable or very comfortable treating a patient with type 1 diabetes who is using an "artificial pancreas."[94]
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Patients with uncomplicated infections should no longer receive fluoroquinolones, given the risk for disabling and potentially permanent adverse events, the FDA said in May. Labels for these antibiotics already warn about the risks for tendonitis, tendon rupture, central nervous system effects, peripheral neuropathy, myasthenia gravis exacerbation, QT prolongation and torsades de pointes, phototoxicity, and hypersensitivity. The FDA has updated the labels to state that the serious risks posed by fluoroquinolones generally outweigh their benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections that are treatable by other means.[95]
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In June, the FDA approved a new device intended to help patients with insomnia fall asleep. In patients with insomnia, the frontal cortex stays active, preventing them from getting deeper, more restorative sleep. These patients often describe a "racing mind" that interferes with getting a sound sleep. The Cerêve Sleep System cools the forehead within a precise, clinically proven therapeutic range, which reduces this activity in the frontal cortex. The software-controlled bedside device cools and pumps fluid to a forehead pad that is worn throughout the night. The system is expected to be launched during the second half of 2017. Some commenters on Medscape's news story pointed out that a cool washcloth or icepack on the forehead might be a less expensive but possibly as effective option.[96]
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A review of statin safety and efficacy data intended to help clinicians and patients make informed decisions was embroiled in controversy and reopened wounds among Britain's leading medical journals in September. The most controversial claim lies in the assertion that the benefits of statins have been underestimated and the risks exaggerated. The investigators argue that claims of "so-called" statin intolerance in up to 20% of patients — which sparked a very public feud after being repeated in two papers published in the BMJ in 2013 — are not supported by large-scale evidence from randomized trials. One commentator in the BMJ said the findings support the benefits of statins. But he added that the investigators didn't consider the limitations of the trial evidence, especially the lack of good data on elderly patients, individual trials unpowered to detect many relevant harms, and variation in how adverse event data were collected. Another commenter pointed out that the use of industry-supported trials to determine safety "simply adds false precision to biased estimates."[97]
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In the final published study of results that were released at a conference in 2015, the researchers provide additional details on the finding that men might be able to lower their risk for prostate cancer by ejaculating frequently. Led by Jennifer Rider, ScD, MPH, a cancer epidemiologist at the Boston University School of Public Health in Massachusetts, the authors say the large prospective study provides the strongest evidence to date of a beneficial role of ejaculation in prevention of prostate cancer. More than 30,000 men were followed for 18 years. Relative risk for prostate cancer was about 20% lower in men who ejaculated at least 21 times a month compared with men who ejaculated 4 to 7 times a month. There was also a significant relative risk reduction of 10% in men who reported 8 to 12 ejaculations per month and of 20% in men who reported 13 to 20 ejaculations per month, both at 40 to 49 years. One independent expert threw the requisite cold water on any firm conclusion. "Association does not mean causation, so one has to be cautious about interpretation," said Janet Stanford, PhD, MPH, a prostate cancer researcher at the Fred Hutchison Cancer Research Center in Seattle, Washington, who was not involved in the study.[98]
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The herbal supplement kratom, derived from a tree (Mitragyna speciosa korth) grown in Southeast Asia, has become increasingly popular as an opioid alternative to treat pain and ease opioid withdrawal. Advocates say it also helps treat depression and anxiety. The drug is currently on the US Drug Enforcement Administration's (DEA's) "drugs of concern" list, and the agency has maintained for years that kratom has a high potential for abuse, that it has no currently accepted medicinal use, and that there is a lack of evidence of its safety. In late August, the DEA announced it would place kratom's active ingredients ― the opioids mitragynine and 7-hydroxymitragynine ― on schedule I, alongside marijuana, ecstasy, and heroin, effectively banning it. On September 30, a bipartisan group of members of the US House of Representatives called on the Obama Administration to halt that plan.[99] An additional public outcry caused the DEA to put a hold on its intent to make kratom illegal pending a public comment period through December 1, according to a document available on the Federal Register website and published on October 13.[100]
In a recent Medscape poll, 56% of respondents said they believe kratom holds promise as an effective opioid alternative vs 33% who were unsure and 11% who said it does not hold promise. On the question of safety, 41% of respondents were unsure vs 37% who said it is safe and 22% who said it is not.[101] In an "Ask the Expert" feature on Medscape, acute adverse effects of kratom are noted as anxiety, irritability, and aggression, as well as opioid-like effects, such as sedation, nausea, constipation, and itching. Long-term high-dose use has been associated with hyperpigmentation of the cheeks, tremor, weight loss, and psychosis.[102] A new review published in the December issue of the Journal of the American Osteopathic Association contends that kratom has some beneficial properties and suggests that the DEA proposal to make it illegal could bring legitimate research to a standstill.[103]
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In May, researchers spotted the first known instance of bacteria impervious to the last-resort antibiotic colistin in the United States, exacerbating fears of superbugs that can turn an ordinary infection deadly. The case involves a 49-year-old woman treated at a clinic in April for a urinary tract infection. A urine culture revealed a strain of Escherichia coli that was later found to be resistant to colistin. However, the woman's infection was not resistant to carbapenem antibiotics. The article did not discuss the woman's current condition.[104] In July, a colistin-resistant strain of E coli bacteria was discovered in a patient who had surgery in a New York hospital in 2015 and was identified as part of the most comprehensive surveillance project for the colistin-resistance gene, mcr-1, to date.[105] In September, two new reports provided reassuring evidence that organisms containing mcr-1 are not easily transmitted to healthy contacts.[106] In a video commentary on Medscape, Paul G. Auwaerter, MD, noted that the bacteria don't cause illness in humans when residing in gut flora or colonizing skin and mucosal surfaces. While this gene has only just been described, it is important because, having plasmid as a basis, these bacteria can spread to a whole host of organisms.[107] Finally, in November, scientists reported having identified chlorhexidine-resistant clinical isolates of Klebsiella pneumoniae that are also cross-resistant to colistin. The finding is alarming because chlorhexidine a common ingredient in disinfectants used in the home and in healthcare settings. The new research suggests that exposure to chlorhexidine is associated with stable resistance to colistin.[108]
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The Advisory Committee on Immunization Practices (ACIP) of the CDC voted in June to recommend that live attenuated influenza vaccine (LAIV; FluMist Quadrivalent, MedImmune) should not be used in the United States for the 2016-2017 influenza season because it has been ineffective for the past three seasons in children aged 2 to 17 years. LAIV is the only nasal spray influenza vaccine; the CDC recommends annual influenza vaccination for all persons aged 6 months and older and says people should use the inactivated influenza vaccine or recombinant influenza vaccine instead.[109] In September, public health leaders expressed concern that the lack of a nasal spray flu vaccine could cause more people to skip immunization.[110] Lisa Grohskopf, MD, MPH, from the National Center for Immunization and Respiratory Diseases/Influenza Division at the CDC, addressed ACIP's recommendations in a Medscape video commentary, also in September.[111] Paul Offit, MD, discussed the possible reasons for FluMist's failure in a separate commentary.[112]
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Theranos had promised to transform its industry with low-cost finger-prick tests but instead has found itself in hot water with government regulators. First in January, CMS told the company in a letter that substandard practices involving hematology at a laboratory operated by Theranos "pose immediate jeopardy to patient health and safety."[113]
On February 12, Theranos submitted a plan to CMS on how it will correct violations at its Newark, California, laboratory.[114] Then, in April, the Department of Justice and the SEC opened criminal investigations of Theranos, the company told its business partners in a memo. Federal prosecutors were said to be conducting a criminal probe into whether the company had misled investors "about the state of its technology and operations," among other issues.[115] In May, Theranos notified CMS that it had voided results from its Edison blood-testing devices for the past 2 years, the Wall Street Journal reported. The company had issued tens of thousands of corrected blood-test reports to doctors and patients, nullifying some results and revising others.[116] In July, Theranos founder and CEO Elizabeth Holmes, once touted as the Steve Jobs of biotech for her company's innovative blood-testing technology, was barred by CMS from owning or operating a lab for at least 2 years. Dealing the biggest blow yet to the privately held company, CMS revoked a key certificate for its California lab and terminated the facility's approval to receive government payments.[117]
In October, Theranos announced it would lay off about 340 workers, or about 43% of its full-time employees, as it closed its clinical labs and Theranos Wellness Centers, signaling a withdrawal from the consumer blood-testing business.[118] And finally, in November, Walgreens Boots Alliance sued Theranos, seeking $140 million in damages, accusing its former lab-testing partner of breaching a contract, as reported by Reuters. Details of the lawsuit were unclear, as Walgreens filed it under seal, citing a confidentiality agreement between the two companies.[119]
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US physicians in April successfully regenerated a patient's badly damaged esophagus using off-the-shelf components approved by the FDA and autologous platelet-rich plasma adhesive gel. Seven years after the surgery and 3.5 years after removal of the metal stents, the patient is able to eat and swallow normally. The epithelium at the wound site now appears normal and contains the proper tissue layers. The landmark case was reported in a paper published online April 8 in The Lancet. The case report provides proof of concept that regrowth of lost esophagus is possible without complex tissue engineering, but the new approach requires validation in animal studies before proceeding to clinical trials.[120]
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The American College of Surgeons (ACS) in August issued a statement on proper dress for surgeons, whether in the operating room or interacting with families or the public outside. The refresher statement was meant to provide evidence-based consensus on appropriate head coverings and when scrubs must be changed, according to the society. "Our fellows were concerned they were being told to do things that weren't necessarily evidence-based," ACS Executive Director David B. Hoyt, MD, told Medscape Medical News. "It just was time for us all to take a step back and say what's the best evidence, what's best practice, and let's all recommit to it." Some of the more common-sense guidelines include the recommendation to change soiled scrubs and/or hats as soon as possible after surgery, and certainly before speaking with family members. Another is to change scrubs and hats after contaminated cases, even if clothing is not visibly soiled. Some commenters on Medscape's coverage asked to see the evidence base for these new recommendations.[121]
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Hormonal contraceptive injections for men were found to be as effective at preventing pregnancy as the female oral contraceptive pill, but researchers stopped their trial because of too many adverse effects. The new study, published in the Journal of Clinical Endocrinology & Metabolism, looked at using regular hormone injections in men as a contraceptive. Adverse effects included depression and mood disorders. There was one death by suicide, but this was not found to be due to the contraceptive injections. Overall, 1491 adverse effects were reported, but 39% were determined to be not due to the hormonal contraceptive injections.[122]
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In June, the United Kingdom voted to exit the European Union (a process known as Brexit), and the ramifications will likely be felt in all aspects of life, including health. The future of the United Kingdom's National Health Service (NHS) featured prominently in the run-up to the referendum and will figure prominently in the changes brought about by the decision.[123] The possible healthcare consequences of the Brexit decision could have a profound effect on the industry in multiple sectors: employers and employees, patients, research, the pharmaceutical industry, health policies, and even the risk for infectious diseases.[124] In a Medscape poll administered shortly after the decision, 67% of respondents agree or strongly agree that Brexit will have a negative effect on healthcare. Of the places that could be negatively affected by Brexit, 26% said United Kingdom only, 33% said United Kingdom and Europe, and 19% said the effects would be felt globally.[125] British patients could end up not being able to access modern medicines if there is a "hard Brexit," a think tank report endorsed by a former Conservative health minister warned in November. While drugmakers currently use the EMA to get drugs licensed across Europe, Britain is likely to drop out of that system if it severs European Union ties and leaves the single market. "The result of 'hard Brexit' would not only be a sick economy but sick patients unable to access a cure," the report noted.[126] Before the vote, leading oncologists spoke out in favor of staying in Europe because of similar concerns around research and drug access.[127] After the vote, an editorial in The Lancet Neurology outlined possible negative effects in the neurology community, including a decrease in research funding and that the practice of young researchers and clinicians working abroad could be under threat, which would damage the ability of UK hospitals and laboratories to attract talented brain health professionals from Europe.[128]
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In April, Junior doctors in England staged their first all-out strike in a dispute over pay and conditions. The NHS said it pulled out all the stops to minimize the risks to quality and safety of care for patients during the 2-day strike.[129] The strike resulted in the cancellation of thousands of operations and hospital appointments. However, in May, the British Medical Association and the Department of Health issued a joint statement saying they'd reached agreement.[130]
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In a Medscape survey of our members in November, the Zika virus epidemic was the biggest medical news of 2016. Sixty-three percent of respondents picked Zika compared with 11% for the national cancer moonshot initiative, 10% for the new MACRA payment model, and 7% for the first state to go MOC-free. Nearly 10% of respondents wrote in other suggestions, such as the election of Donald Trump and the coming repeal of the ACA (written in the most by far), success of transcatheter aortic valve replacement, CRISPR and gene editing, the artificial pancreas approval, antibiotic resistance, the opioid overdose epidemic, and EpiPen's high cost, among others.
The event or news that most frustrated Medscape's members this year was Donald Trump winning the presidency and the potential implications for healthcare policy, at 30%. Next was increasingly high drug costs at 26%, the report that medical errors are the third leading cause of death in the United States at 14%, and the opioid overdose epidemic being described as "doctor-driven" at 12%. Other areas of frustration were the new MACRA payment model (7%), MOC "not eliminated yet for my specialty or state" (5%), and the continuing spread of Zika virus throughout the world (2%). Write-ins under "Other" (4%) included ACA premium increases, medical facilities and personnel being targeted in the Syrian civil war, and Theranos.
The most exciting medical news or event in 2016 according to Medscape's members was FDA approval of the first "artificial pancreas" for type 1 diabetes, at nearly 31%. A close second, at nearly 28%, was Donald Trump winning the presidency and the potential implications for healthcare policy. Third was the cancer moonshot initiative (23%), fourth was the first US state to go MOC-free (9%), and last was the first device approved to treat insomnia (3%). Write-in suggestions made up more than 6% of responses and included fewer people uninsured under the ACA, gene editing with CRISPR, and various cancer therapies.
Clinicians said they thought the most interesting medical advance or research study finding this year was FDA approval of the first "artificial pancreas" for type 1 diabetes, at 38%. Next was the birth of the "three-parent baby" using mitochondrial manipulation technology (19%). Third was successful esophagus regeneration in a patient (8%). A virtual tie for fifth place was the first attempt at uterus transplantation in the United States (5.6%) and the first device approved to treat insomnia (5.5%). Other suggestions (5.5%) were gene editing with CRISPR, melanoma treatment progress, EMPA-REG OUTCOME trial results, PARADIGM-HF trial results, increasing use of Narcan, and greater recognition of the opioid overdose epidemic.
And finally, Medscape's Year in Medicine survey asked our members what they thought was the most important medical advance or research study finding this year. Again, the most clinicians selected FDA approval of the first "artificial pancreas" for type 1 diabetes, at 38%. Next was the new gene editing tool using CRISPR technology at 34%. Third place was a large drop to 9% for the successful esophagus regeneration in a patient. That was followed by the first device approved to treat insomnia (3%) and the first uterus transplantation attempted (3%). Those who selected "Other" (just under 4%) suggested monoclonal antibody advances, progress in cancer immunotherapies, microbiome's impact on human health, stem cell regeneration therapies, oral desensitization of food IgE-mediated allergies, and antibiotic use causing asthma and atopia in children.
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