Monthly Archives: September 2017

Place More Value on Talking with Patients, Experts Say

Shared decision-making works well, but requires time
by Joyce Frieden, News Editor, MedPage Today September 26, 2017

WASHINGTON — Paying doctors more for simply sitting and talking with their patients — rather than basing payment more on quality measures — would be a great way to improve the doctor-patient relationship, Andy Lazris, MD, said here Tuesday.
Today, “if you discuss something with the patient, you lose on quality measures” because you’re not spending the time performing a recommended test or procedure, said Lazris, who is co-chairman of the Right Care Alliance Primary Care Council. “That’s antithetical to [good] decision-making.” He spoke at a briefing on the doctor, patient, and government relationship sponsored by Politico, Center Forward, the Doctor-Patient Rights Project, and the Galen Institute.
Lazris works in an accountable care organization with many elderly patients, so a lot of the regular quality indicators don’t apply, he said.
“To me, quality measures should be ‘You’ve had that discussion’,” he continued. “I don’t want to lower my 85-year-old patient’s blood pressure too low, but if I lower enough that they faint and break their hip, I would have passed that [hypertension] quality measure.”
Part of the difficulty in trying shared decision-making with patients is lack of time, said Yalda Jabbarpour, MD, assistant professor of family medicine at Georgetown University in Washington. “Expanding that time in the office … would help the patient.”
Talking with patients has “almost a metaphysical aspect” to it, according to Sen. Bill Cassidy, MD (R-La.), a gastroenterologist. “Imagine you’re with a friend and another friend has died. As you speak to your friend, you measure in their body language and their eyes how they’re receiving it … That is the key to the doctor-patient relationship,” he said.
Even when a physician is tired and supposed to go home, “when a patient has cancer, but she can’t hear you say, ‘There’s hope’ because all she hears is ‘cancer’ — let me take a little more time, let me not tap away on the computer which the government tells me I have to do or I don’t get paid,” he continued. “We need to take the time to look in the patient’s eyes and say, ‘There’s hope.'”
There is data that shows that taking this kind of approach — with patients involved in medical decision-making — works well, said Sen. Jeanne Shaheen (D-N.H.). “Data show that if you implement this model, not only do patients tend to choose the less invasive procedure, they are happier, physicians are more satisfied working with that kind of model, and costs go down … There are all kinds of reasons why we should encourage this model.”
The ongoing battle over healthcare reform makes trying to implement this type of change in reimbursement a challenge, Shaheen said. “We can never get to those discussions … unless we get over this Groundhog Day we’re in now where we continually decide whether to repeal the Affordable Care Act or go forward with it. We have got to get to that point where we can talk long-term about what we want to do with healthcare.”
Transparency about healthcare costs and tradeoffs also will be key to encouraging shared decision-making, said David Barbe, MD, president of the American Medical Association. “As physicians and patients are discussing treatment options, it may be impossible as the family physician to know which [specialist] physicians are on the patient’s network and how much hospitalization might cost. There may be ways [to get that information] and help people make informed decisions.”
This should extend to physician outcomes as well, to include outcomes and patient satisfaction data, said Rep. Roger Marshall, MD (R-Kan.), a retired ob/gyn. “Medicare would collect data on me and compare me to other doctors at similar hospitals … ‘This is what Dr. Marshall spends on average hysterectomy; this is his average length of stay, this is his readmission rate.'”
Another issue is making sure to include patient-reported outcomes in quality measures, said Kim Templeton, MD, immediate past president of the American Medical Women’s Association. “When looking at quality, it should not just be ‘Did you order a specific test?’ but also ‘How did the patient do?'” she said. “This is where we really need to engage the patient … Unfortunately, while process measures are easy to measure, patient-reported outcome measures are not available for all conditions and are some of the most challenging things to measure.”
For one thing, men and women are very different when it comes to medical care, “and process measures don’t necessarily take that into account, and a lot of patient-reported measures don’t [either],” Templeton said. For instance, “depression manifestation is different in women than in men but that’s something you don’t necessarily get in a process measure.”
The speakers had some definite ideas about what Congress might do to help solve some of these problems. “One thing … is to pay doctors as much to talk to patients as to do something,” said Lazris. “You’ll get more primary care physicians, the healthcare system will be saved, and patients will be saved.”
“Align measures to make them more simple, and give things time to mature,” said Jabbarpour. “It’s hard for physicians to keep adapting to more measures.

Pfizer Spin-off to Pull New Products from Drug Junkpile

Following industry trends, the pharma giant creates a start-up
by Damian Garde, STAT News September 26, 2017

There’s a popular theory about the limitations of global pharma companies: For all their skyscrapers and strategy reviews and private jets, they’re simply too knotted up in bureaucracy to realize how many great drugs are gathering dust in their vaults.
Now, the biggest of Big Pharma is out to do something about that. Pfizer, home to nearly 100,000 employees, on Monday announced the launch of a six-person startup to develop new drugs.
This may seem odd in that Pfizer spends literally billions of dollars a year advancing treatments of its own. But the company’s executives say they simply don’t have the resources to advance all the promising compounds that catch their eye — and they believe an independent company with the scrappy ethos of a startup will be in a better position to take on that task.
“The problem is very simple: There’s too much good science and not enough resources to advance it,” said Dr. Lara Sullivan, a former Pfizer vice president who is now leading the startup.
“If you want to see grown men cry, stop a program for budget reasons, not based on science,” Sullivan said.
The new spin-off, SpringWorks Therapeutics, is getting started with $103 million from investors including Pfizer and Bain. It will focus at first on four Pfizer-invented therapies, for conditions including post-traumatic stress disorder and rare forms of cancer. All are already in clinical trials. The two most advanced therapies, targeting tumors found on connective tissue and nerves, will advance to the final stage of development in the coming year.
SpringWorks, which will be based in New York, also plans to scour the pipelines of other pharma companies for compounds that have been set aside for lack of resources, hoping to license some of them for further testing.
It’s a business idea that has been gaining steam of late.
Roivant Sciences, founded by an ex-hedge fund manager in 2014, has built a cottage industry on the same principle, licensing unwanted therapies from the likes of GlaxoSmithKline and Takeda and then launching small startups to test them.
BridgeBio Pharma, established in 2015, takes a similar approach, searching academia and pharma alike for early-stage projects in the field of inherited disease. “We have what we call a better-owner model,” CEO Neil Kumar said. “We try to advance things as far as possible until we’re clearly not the best owner for the asset.”
The concept of scavenging for waylaid gems is considered so promising that Roivant has raised more than $1 billion to widen its search. Its 32-year-old founder, Vivek Ramaswamy, landed on the cover of Forbes, and two Roivant spin-offs pulled off a pair of biotech’s largest-ever Wall Street debuts.
Neither Roivant nor BridgeBio, however, has yet brought a drug to market.
And they’re dogged by the same questions that will follow SpringWorks: If these discarded compounds are so promising, why were they discarded in the first place? And how can a startup push them along better than a multinational heavyweight?
“What I’d say is that from the ground up we’re different,” said Saqib Islam, SpringWorks’ chief financial officer and chief business officer.
The company doesn’t intend to push for quick-turnaround returns on investment, he said. And it plans to work alongside the companies that originally invented or discovered each compound — such as Pfizer — to take advantage of in-house expertise.
“We think that’s the distinction that will draw some attention from those looking to partner their assets going forward,” Islam said.
Pfizer’s decision to wade into the space follows years of navel-gazing at major pharma companies, which have long envied the agility and nothing-to-lose gusto of biotech startups.
Conscious of how the comforts of corporate largess can be counterproductive, companies including GlaxoSmithKline and AstraZeneca in the past sought to create mini-startups within their own walls. But though they tried to replicate the feverish immediacy of startup culture, that proved almost impossible when the employees knew they were operating above the multibillion-dollar safety net of a huge pharma company.
Pfizer’s move to create an independent company — deliberately safety net-free — suggests the biggest wheels of the drug industry have learned an important lesson, said Bernard Munos, a former R&D executive at Eli Lilly who now consults for pharma companies.
“I think the industry has realized that they have not really been true to their words in terms of embracing innovation,” Munos said. “So this is very encouraging, frankly, especially coming from Pfizer.”

Damian Garde covers biotech and writes The Readout newsletter.
This post originally appeared on STAT News.
last updated 09.26.2017

DNR Orders Skew HF Mortality as Quality Metric

Adjusting for it ‘would be a step in the right direction’
by Nicole Lou, Reporter, MedPage Today/CRTonline.org September 25, 2017

Current ways to risk-adjust heart failure mortality as a measure of hospital-level quality are insufficient, suggested a study showing that accounting for do-not-resuscitate (DNR) orders reshuffles institutional rankings.
Hospitals in California had a median 8.7% rate of DNR orders among heart failure patients, ranging from 0% to 53.8%. A DNR order initiated within 24 hours of admission was associated with greater odds of in-hospital death (9.9% versus 2.1% without DNR, adjusted RR 3.63, 95% CI 3.17-4.16). Hospitals with more DNR patients reported higher risk-standardized mortality (P<0.001).
Accordingly, DNR status improved the models used to benchmark hospital mortality. The c-statistic increased from 0.821 to 0.845, yielding 17% additional model explanatory power, Jeffrey Bruckel, MD, MPH, of New York’s University of Rochester Medical Center, and colleagues reported in the October issue of JACC: Heart Failure.
Moreover, accounting for DNR orders reduced the number of outliers — hospitals with greater mortality than expected for their case mix — down from 22 to 14.
“Given public reporting of heart failure mortality measurements and their influence on reimbursement, accounting for the presence of early DNR orders in quality measures should be considered,” the investigators suggested.
One such tie with reimbursement is the CMS Value-Based Payment System, which takes 2% of group payments and redistributes it according to hospital performance.
“Currently, a 13% 30-day all-cause mortality rate for heart failure places a hospital in the top 20%, whereas an 11% rate puts them in the bottom 20%,” according to an accompanying editorial by Paul Heidenreich, MD, of California’s VA Palo Alto Health Care System.
“Although we care about mortality, it is not clear we should care as much about published hospital mortality rates,” Heidenreich said, likening them to fatal plane crash rates: “I accept these rates as accurate; but then, why am I more concerned about leg room and in-seat power? I (and I expect most others) feel these small differences in mortality rates are more likely due to chance, and do not represent a systematic safety difference.”
Heidenreich emphasized that 30-day heart failure mortality, as a quality measure, is “only as good as its signal-to-noise ratio.”
He added, “the signal (variation in mortality due to quality differences) is small compared with the noise (variation in mortality due to everything else). Ironically, as hospitals improve their processes of care, and the quality improves across the board, this signal/noise ratio will only worsen, making 30-day mortality rates even less useful.”
The 2011 California State Inpatient Database (SID) accessed by Bruckel’s group contain the only administrative claims in the U.S. linked to early DNR orders. The uniqueness of this database, along with some missing data (such as outpatient diagnosis codes), were limitations.
In total, 55,865 patients hospitalized at 290 hospitals were included. Of those, 12.1% had an early DNR order in place. Older patients, women, and those with dementia, metastatic cancer, or leukemia were more likely to have a DNR order.
“Based on median odds ratio results, the hospital to which a patient was admitted was more strongly associated with receipt of a DNR order than the strongest clinical predictors in the model,” Bruckel and colleagues wrote. “This finding mirrors previous research demonstrating that DNR use is strongly influenced by patient factors such as race, socioeconomic status, and education, as well as physician and institutional culture and practice norms.”
“We clearly need to adopt better measures of the quality of heart failure care. Until then, adjusting mortality for DNR status would be a step in the right direction,” Heidenreich concluded.

Bruckel reported advising for AvantGarde Health.
Heidenreich disclosed no relevant industry ties.
• Primary Source
JACC: Heart Failure
Source Reference: Bruckel J, et al “Variation in do-not-resuscitate orders and implications for heart failure risk-adjusted hospital mortality metrics” JACC Heart Fail 2017; DOI: 10.1016/j.jchf.2017.07.010.
• Secondary Source
JACC: Heart Failure
Source Reference: Heidenreich P “Using 30-day mortality to measure quality of heart failure care” JACC Heart Fail 2017; DOI: 10.1016/j.jchf.2017.08.016.

FDA Shuts Down Online Pharmacies

Seized 100 web domains as part of international effort against counterfeit meds
by Kristina Fiore, Deputy Managing Editor, MedPage Today September 25, 2017

The FDA seized the website domains of nearly 100 online pharmacies — including buyhydrocodoneonline.com and buyklonopin.com — and sent 13 warning letters to the operators of 400 other sites for selling unapproved prescription drugs.
The agency also confiscated some 500 packages that were ordered from those sites, it said in a statement.
FDA’s efforts were part of Operation Pangea, an annual global effort led by Interpol to fight the sale and distribution of illegal and potentially counterfeit or substandard medical products on the internet. This was the 10th annual intervention — it started in 2008 — and Reuters reported that about 25 million illegal or counterfeit drug products were seized and more than 3,500 websites were shut down around the world.
“Consumers go to these websites believing that they are buying safe and effective medications, but they are being deceived and put at risk by individuals who put financial gains above patient safety,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
Gottlieb noted that the sale and distribution of illegal opioids online is particularly troubling, given the nation’s problems with prescription painkiller abuse: “The ease with which consumers can purchase opioid products online is especially concerning to me, given the immense public health crisis of addiction facing our country,” he said. “Some of the websites sold unapproved versions of multiple prescription opioids directly to U.S. consumers.”

FDA Warns on Proper Dosing for Liver Drug

19 deaths with obeticholic acid, many in patients receiving more than recommended dose
by John Gever, Managing Editor, MedPage Today September 21, 2017

WASHINGTON — In the 13 months after obeticholic acid (Ocaliva) was approved in May 2016, 19 patient deaths were reported to the FDA, the agency said Thursday, at least some of which appeared to stem from doses higher than recommended on the drug’s label.
Of these 19 fatalities, the agency determined that seven were in patients with moderate to severe liver impairment who were taking the drug at 5 mg daily; the drug’s label states that patients with this degree of impairment should not receive more than 10 mg twice weekly, the FDA said. For most of the other fatal cases, not enough information was provided to identify causes or contributing factors.
The agency also received reports of additional non-fatal cases of serious liver injury involving patients with liver impairment in whom dosing was excessive.
Obeticholic acid is approved for treating primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid.
“Healthcare professionals should determine the patient’s baseline liver function prior to starting Ocaliva. Patients with moderate to severe liver impairment (Child-Pugh B and C) should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5 mg daily dosing used for other PBC patients, and if needed, can be increased up to a maximum approved dose of 10 mg twice weekly,” the FDA said in its Drug Safety Communication about the issue.
Patients’ liver function should be monitored while on therapy, the agency added, with doses reduced if patients progress to moderate or severe impairment.
The drug “may also be associated with liver injury in some patients with mild disease who are receiving the correct dose,” the FDA noted. It said it was working with drugmaker Intercept Pharmaceuticals to address the apparent dosing confusion.

CardioBrief: Stopping Aspirin Hikes CV risk

37% increase in events seen after discontinuation in Sweden
by Larry Husten, CardioBrief September 25, 2017

People who quit taking aspirin have an increased risk for a cardiovascular event, a large national registry has shown.
The use of aspirin for primary prevention against cardiovascular disease has fallen from favor in recent years but aspirin for secondary prevention is still broadly popular and supported by guidelines.
Many people who take aspirin, whether for primary or secondary prevention, discontinue treatment over time. Previous studies have suggested that these people are at higher risk for a new cardiovascular event, but these studies typically relied on self-reported data and may suffer from other methodological limitations.
To overcome some of these limitations, Swedish researchers used a comprehensive national registry to analyze the association between discontinuation of long-term aspirin treatment and subsequent cardiovascular events. In a paper published in Circulation, Johan Sundström (Uppsala, Sweden) and colleagues analyzed data from more than 600,000 people in Sweden who were prescribed low-dose aspirin. After 3 years, 15% of long-term, low-dose aspirin users were no longer taking aspirin.
Discontinuation of aspirin therapy was associated with a 37% greater risk of cardiovascular events. The increase occurred almost immediately after discontinuing therapy, supporting the idea that aspirin discontinuation produces a rebound effect. The early increase in risk did not appear to diminish over time, the authors reported.
The findings correspond to an absolute increase of 13.5 events per 1,000 person-years, or one additional CV event in 1 year for every 74 patients who discontinued aspirin.
Of the study population, 54% took aspirin for secondary prevention and 46% for primary prevention. The risk reduction was much bigger in the secondary prevention population — a 46% increase in risk versus a 28% increase in the primary prevention population. This translated into one additional CV event in 1 year for every 36 patients in the secondary prevention population compared with every 146 patients in the primary prevention population.
“Low-dose aspirin therapy is a simple and inexpensive treatment,” said Sundström, in a press release. “As long as there’s no bleeding or any major surgery scheduled, our research shows the significant public health benefits that can be gained when patients stay on aspirin therapy.”
But the bleeding issue remains problematic. Responding to an email question, Sundström acknowledged that the investigators did not report the change in bleeding complications after people stopped taking aspirin. Thus, the risks versus benefits of discontinuing aspirin cannot be fully assessed based on the data in this paper.
“CVD prevention guidelines unequivocally recommend aspirin anyway in high-risk patients,” Sundström said.
For the lower-risk primary prevention population, however, the risk to benefit equation is much more difficult to assess and requires a careful consideration of bleeding complications. Sundström said that “the lack of such information is a limitation of the paper.”

Electric Stimulation ‘Awakens’ Man from Vegetative State (STAT)

Scientists in France may have discovered a key to helping those with brain trauma
by MedPage Today Staff September 25, 2017

Scientists from France’s National Center for Scientific Research report that a patient in a persistent vegetative state demonstrated signs of consciousness after electric stimulation, according to STAT.
The man was in a vegetative state for 15 years following injury sustained in a car accident. The researchers implanted the device in his chest and stimulated the vagus nerve for a month, after which he became “minimally conscious, responding to some signals from the outside world,” showing signs of a stronger theta signal.
There’s no word from the scientists in this study if this type of therapy can be scaled to treat a large population of patients.

Breathing Dirty Air May Increase Kidney Disease Risk

Fine particulate exposure may cause 45,000 cases of CKD annually
by Salynn Boyles, Contributing Writer September 22, 2017

Action Points
• Note that this observational study using Veterans Administration data suggests that exposure to fine particulate pollution is associated with a higher risk of incident kidney disease.
• The authors note that fine particles can cross the lung-blood barrier, which might make them susceptible to filtration by the kidney.

Exposure to fine particulate air pollution appeared to be associated with an increased risk for chronic kidney disease (CKD) and progression to end-stage renal disease (ESRD), according to a newly published epidemiologic study involving close to 2.5 million U.S. veterans followed for approximately 8 years.
The study, published online in the Journal of the American Society of Nephrology, relied on air pollution data from the Environmental Protection Agency (EPA) and NASA satellites and showed a linear relationship between fine particulate matter exposure and risk of kidney function decline and kidney disease.
Based on the analysis, the researchers estimated that about 45,000 new cases of kidney disease and 2,400 new cases of kidney failure each year can be attributed to particulate matter air pollution exposures exceeding the level the EPA considers safe.
Nephrologist Ziyad Al-Aly, MD, of the Veterans Affairs Saint Louis Health Care System, who led the study, told MedPage Today that air pollution exposure may play a significant role in the rising incidence of kidney disease that is not able to be explained by comorbidities such as high blood pressure and diabetes.
“Hypertension and diabetes are major risk factors for kidney disease, but there has been a surge of cases among people without hypertension or diabetes, and this phenomenon is very common in areas with high pollution. We think this might explain some of the burden of kidney disease that has no known cause.”
Air pollution, especially fine particulate matter <2.5 µm in aerodynamic diameter (PM2.5), is a well-established risk factor for heart disease, respiratory disease, and death. But Al-Aly said few previous studies have examined the potential impact of PM2.5 on kidney function in humans.
He noted that laboratory studies have linked exposure to deep exhaust particles of 2.5 micrometers and smaller to renal injury in mice. Higher mortality from kidney disease has also been identified in the coal mining regions of Appalachia.
The study is the first large epidemiologic analysis to examine the possible impact of PM2.5 exposure on the development of chronic kidney disease and the progression of kidney disease.
The researchers linked EPA and Department of Veterans Affairs databases to build an observational cohort of 2,482,737 U.S. veterans, and used survival models to evaluate the association of PM2.5 concentrations and risk of incident estimated glomerular filtration rate (eGFR) <60 ml/min per 1.73 m2, incident CKD, eGFR decline ≥30%, and ESRD over a median follow-up of 8.52 years.
County-level exposure was defined at baseline as the annual average PM2.5 concentrations in 2004, and separately as time-varying, where it was updated annually and as cohort participants moved.
The researchers also examined PM2.5 estimates derived from NASA satellite sensors as an alternative data source to define ambient PM2.5 exposure levels.
Analyses of baseline exposures (median, 11.8 [interquartile range, 10.1–13.7] µg/m3), showed a 10-mg/m3 increase in PM2.5 concentration to be associated with increased risk of eGFR <60 ml/min per 1.73 m2 (HR, 1.21; 95% CI, 1.14-1.29), CKD (HR, 1.27; 95% CI, 1.17-1.38), eGFR decline ≥30% (HR, 1.28; 95% CI, 1.18-1.39), and ESRD (HR, 1.26; 95% CI, 1.17-1.35).
Time-varying analyses revealed that a 10-mg/m3 increase in PM2.5 concentration was associated with a similarly increased risk of eGFR <60 ml/min per 1.73 m2, CKD, eGFR decline ≥30%, and ESRD. Spline analyses showed a linear relationship between PM2.5 concentrations and risk of kidney outcomes.
NASA-derived satellite data showed similar results.
“The results were robust in sensitivity analyses including the estimation of different distance thresholds from an air-monitoring station (30, 10, and 5 miles), and analyses evaluating the association within metropolitan areas,” the researchers wrote. “The constellation of findings suggests that chronic exposure to fine particulate matter air pollution is a significant risk factor for the development and progression of kidney disease.”
Al-Aly said this makes sense, because fine particulate matter air pollution of <2.5 µm in diameter permeates lung tissue following inhalation and enters the blood stream: “Human kidneys filter as much as 45 gallons of blood a day. They may be especially susceptible to the harmful effects of particulate matter in the blood.”

Funding support for the study was provided by the U.S. Department of Veterans Affairs.
Al-Aly and co-authors reported having no relevant relationships with industry related to the study.
• Reviewed by F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner
• Primary Source
Journal of the American Society of Nephrology
Source Reference: Bowe B, et al “Particulate matter air pollution and the risk of incident CKD and progression to ESRD” J Am Soc Nephrol 2017; DOI: 10.1681/ASN.2017030253.

Helping Patients with Type-1 Diabetes Prepare for a Religious Fast

Tyler Basen shares how he fares as a patient with diabetes and gives some tips for clinicians
by Tyler Basen, MD – Contributing Writer, MedPage Today
This article is a collaboration between MedPage Today® and: THE ENDOCRINE SOCIETY

There are several holidays that may make it difficult for people with diabetes to control their blood sugar. Holidays are supposed to be quality time spent with family and friends so it’s only reasonable for patients to be frustrated during these times whether fasting or even when an abundance of food is part of the celebration. As more of a “cultural Jew” I still take part in many of the major holidays and a particularly difficult one for me is Yom Kippur.
Yom Kippur in Judaism is considered the holiest day of the year as it is the Day of Atonement where you repent for your sins and participate in a 25-hour fast. Even before I was diagnosed with type 1 diabetes, this obviously was not an easy task. But add two different insulins and frequent blood sugar checks into the mix and it can seem quite impossible. My goal in this article is to provide some information and to emphasize that for those of us with diabetes can enjoy the holidays without falling victim to blood sugar madness.
The danger of fasting in acute setting
I will first start by stating that under Jewish law it is okay to refrain from fasting because of a primary health concern. Fasting can be extremely dangerous in the acute setting because of the risk for hypoglycemia and even hyperglycemia.
Ramadan is another holiday where fasting is part of the observance. In fact, a study showed that 43% of people with type 1 diabetes and 79% of people with type 2 diabetes in 13 Islamic countries fast during Ramadan. Another study underscores this by showing a correlation between adequate glycemic control before Ramadan in adolescents with controlled glucose profiles during the fast. Endocrinologists should counsel their patients about fasting and discuss an individualized plan and any medication adjustments.
These and other studies have pointed out that that the risk of being hospitalized for hypoglycemia during a fast can range from a threefold to a more than fourfold higher risk in people with T1D. It is important to explain to patients that if their diabetes is currently not under control, it is recommended that they do not participate in the fast.
Making a fast more manageable for those with diabetes
I have fasted for an extended period of time and can provide some recommendations to make it more manageable. First, the biggest mistake by far is for patients to not take their 24-hour or long-acting insulin such as Lantus either the night before or the morning of a fast. This is similar to the trap of withholding Lantus prior to an upcoming surgery. Doing this will only significantly increase the risk of severe hyperglycemia, as basal insulin is needed to counteract stress hormones such as adrenaline and cortisol. I normally take 12 units of Lantus at night and even if I just eat a late lunch, I will become mildly hypoglycemic. This works for me however, because ordinarily I stick to a regimented meal schedule. I believe it also helps with hyperglycemic fluctuations particularly post-prandial because my fasting sugar prior to a meal is not already on the higher side such as 140-150mg/dl. Other people with diabetes may take slightly less basal insulin and may not become hypoglycemic if they are forced to eat lunch at 3 p.m. Thus, this individualized approach is crucial to understand before attempting to adjust basal insulin during a fast for Yom Kippur or Ramadan.
What adjustments should be made to basal insulin dosing before a fast?
Unfortunately, there is no right answer to this because it is different for every person with diabetes. I have tested different regimens so before an extended fast trial and error is important. For me, decreasing from 12 units to approximately 8 units or a 33% reduction was appropriate for a full day fast. One study followed diabetes patients on insulin pump therapy during a Ramadan fast and concluded the basal insulin regimen during the fast either remained unchanged or decreased by 5.5% to 25.0%. Thus, as a general statement if a person with diabetes is more prone to hypoglycemia with even short fasts then a larger reduction in the basal regimen should be anticipated for a 24-hour fast.
What other precautions can be made to prevent severe complications during a fast?
During Yom Kippur, I did not refrain from drinking water. I believe this to still be a respectable way to participate in a fast because it still shows sacrifice by refraining from eating. Becoming dehydrated can have so many adverse health outcomes for those with diabetes that I did not want to put myself at risk. Severe dehydration can make you more prone to diabetic ketoacidosis (DKA) and have harmful effects on the kidneys. Other precautions include having family or friends close if help is needed and to check your blood sugar multiple times throughout the fast. Additionally, always keep glucose tablets or granola bars nearby if severe hypoglycemia occurs and end the fast if needed. It’s important to let patients know that while it’s important to share the holidays with family, there is no shame in protecting their own health.

Expert Critique
FROM THE ENDOCRINE SOCIETY Reading Room

Religious fasts of varying durations, such as those mentioned in this article—Ramadan and Yom Kippur—are examples of holiday practices that can have a significant impact on both the belief systems and self-care of patients with diabetes. This article references some data for type 2 diabetes, but has particular focus on unique issues that affect those with type 1 diabetes, mainly managing basal insulin and preventing DKA with adequate hydration.

As emphasized by Dr. Basen, fasting can cause significant hypoglycemia or hyperglycemia that can be treated and, more importantly, potentially prevented with some planning. He stresses the need for patients to adjust, but not hold or forget to take, basal insulin. Since each patient is different, as described in the reference regarding insulin pump changes during Ramadan, individual tailoring of insulin dosing is imperative as people with diabetes have a wide range of underlying insulin resistance and sensitivity.

An overarching theme of the article is that patients with diabetes and their providers should work together to find a balance between the socio-religious importance of a holiday fast on family and the individual psyche while preserving good blood glucose control throughout the fast. Preventing severe hypoglycemia, hyperglycemia, DKA, and dehydration is possible. Patients with diabetes can preserve the significance of a religious fast, but also do everything possible to prevent complications caused by the absence of food or too much insulin.

The world is running out of antibiotics, WHO says

By Susan Scutti, CNN
Updated 6:01 PM ET, Tue September 19, 2017

(CNN)Too few new antibiotics are under development to combat the threat of multidrug-resistant infections, according to a new World Health Organization report published Tuesday. Adding to the concern: It is likely that the speed of increasing resistance will outpace the slow drug development process.
As of May, a total of 51 antibiotics and 11 biologicals — medical products often made from natural sources — are being developed, the new report said.
“The idea is that biologicals could replace use of antibiotics, which could help in overcoming the resistance problem,” Peter Beyer, an author of the report and senior adviser to the WHO’s Department of Essential Medicines and Health Products, wrote in an email.
Seemingly, this large number of potential new drugs should suffice, yet it is not nearly enough.
First, just 33 of the antibiotics in the pipeline target priority pathogens. This year, the WHO published a list of a dozen “priority pathogens”: 12 separate families of antibiotic-resistant bacteria that pose the greatest threat to human health.
Among the priority pathogens is a drug-resistant tuberculosis, which kills about 250,000 people around the world each year, and a variety of multidrug resistant strains — Acinetobacter, Pseudomonas and various Enterobacteriaceae — which are responsible for infections in hospitals and nursing homes and among patients whose care requires ventilators and catheters.
Of the 33 potential medicines for treating priority bug infections, only eight are innovative treatments. The other 25 are simple modifications of existing families of antibiotics. At best, then, the 25 will serve as short-term solutions since it is expected bacteria will quickly adapt to and resist these new (though somewhat familiar) drugs, according to the WHO.
“It is difficult to speculate why companies develop specific new medicines,” Beyer noted. “But in general many new treatments do not necessarily constitute advances over existing treatments.”
TB infections require a combination of at least three antibiotics, according to the new report, yet only seven of the new TB medicines are even in clinical trials. Soon, there will be a serious lack of treatment options for this infection, the report warns.
The same is true for gram-negative pathogens, which can cause severe, often deadly infections typically in hospitals and nursing homes.
Gram-negative bacteria have more complex cell walls than gram-positive, explained Beyer. “In a nutshell, it is more complex to develop a novel antibiotic that can penetrate the complex gram-negative cell wall and stay inside the bacterium,” he wrote.
Finally, the WHO sees too few oral antibiotics being developed. These are necessary “to target the critical priority pathogens (and) be accessible in low- and middle-income countries,” Beyer noted.
To address the problem of developing new antibiotics, the WHO and the Drugs for Neglected Diseases Initiative set up the Global Antibiotic Research and Development Partnership. However, new drugs alone cannot combat the threat of antimicrobial resistance. The WHO is also working to improve infection prevention and control while developing guidance for the responsible use of antibiotics.
“Always seek medical advice before taking antibiotics and then always follow the advice of the health-care professional,” Beyer noted.
The new report is a “fantastic (and very useful!) summary” of the antibiotic situation, wrote Bill Hanage, an associate professor of epidemiology at Harvard T.H. Chan School of Public Health, in an email. Hanage, who has also published studies of antibiotic resistance, was not involved in the new report.
Although the risk of getting a completely resistant infection is low in the United States, about 2 million people each year become infected with “resistant enough” bacteria that are harder to treat, Hanage said. And every year, more than 20,000 people die of these infections.
“More resistant infections don’t just mean you or someone you care about is more likely to die from one, they also mean healthcare will get even more expensive,” Hanage said. “Many of the procedures we take for granted in medicine, from cancer treatments to surgeries, depend on our ability to handle infections that happen in the course of treatment.”
The number of new drugs in development is simply not enough, he said.
“The great majority will not make it into the hands of doctors or your treatment,” Hanage wrote. “As the report states, for drugs to be used in humans they have to pass 3 hurdles, the phase 1, 2 and 3 trials. Drugs entering that pipeline have just a 14% chance of getting all the way through to be used in humans.”