Scott Gottlieb resigns as FDA commissioner

Scott Gottlieb, MD, announced today that he will resign as commissioner of the US Food and Drug Administration (FDA) in the coming weeks to spend more time with his family.

"I'm immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together, and the strong support of @SecAzar and @realDonaldTrump - This has been a wonderful journey and parting is very hard," Gottlieb said in a tweet.

Gottlieb has been universally popular in the 2 years since he's had the job, most recently managing the FDA during the government shutdown. His resignation was not requested by President Donald Trump.

In a statement posted to Twitter, Health and Human Services Director Alex Azar said Gottlieb oversaw a record number of approvals for innovative drugs while simultaneously increasing the number of affordable generic drugs. His signature issue, according to the Washington Post, was teenage vaping.

Gottlieb, 45, commuted to Washington D.C. each week from Connecticut, where he and his wife have three school-age children.

At this time there is no word on a replacement.
Scott Gottlieb Twitter feed
Alex Azar Twitter feed
Mar 5 Washington Post story


Study—again—shows no connection between MMR vaccine and autism 

Another study, this one a massive undertaking in Denmark, demonstrates no connection between the measles, mumps, and rubella (MMR) vaccine and autism. The study was published today in the Annals of Internal Medicine.

The study followed 657,461 children born in Denmark from 1999 through 2010, with follow-up from 1 year of age and through August of 2013. Hazard ratios of autism were calculated according to MMR vaccination status, with adjustment for age, birth year, sex, other childhood vaccines, sibling history of autism, and autism risk factors (based on a disease risk score).

During follow-up, 6,517 children were diagnosed as having autism (incidence rate, 129.7 per 100 000 person-years).

"Comparing MMR-vaccinated with MMR-unvaccinated children yielded a fully adjusted aHR [autism hazard ratio] of 0.93 (95% CI [confidence interval], 0.85 to 1.02)," the authors wrote. "Similarly, no increased risk for autism after MMR vaccination was consistently observed in subgroups of children defined according to sibling history of autism, autism risk factors (based on a disease risk score) or other childhood vaccinations, or during specified time periods after vaccination."

The study comes more than 20 years after British physician Andrew Wakefield published a retracted study in The Lancet showing that 8 out of 12 case-patients with autism first exhibited symptoms within 4 weeks of receiving the MMR vaccine. 

Several studies have since disproved and discredited Wakefield's work and have demonstrated no link between vaccines—including the MMR vaccine—and autism, but this is the first study to show that the MMR vaccine does not trigger autism in subgroups of susceptible children, according to a summary of the study for patients published in the same journal.
Mar 5 Ann Intern Med study
Mar 5 Ann Intern Med summary
Mar 5 Ann Intern Med editorial


Saudi Arabia records 4 new MERS cases, including 1 in Wadi ad-Dawasir

The Saudi Arabian Ministry of Health (MOH) today recorded four more cases of MERS-CoV, including one case in Wadi ad-Dawasir, the site of a large hospital-based outbreak.

Two cases of MERS-CoV (Middle East respiratory syndrome coronavirus) are in women from Riyadh, which saw a number of cases this past weekend. A 22-year-old and 44-year-old, whose infections are both listed as secondary cases, were diagnosed with the virus. Neither woman reported contact with camels.

In addition, a 47-year-old man from Wadi ad-Dawasir who had contact with camels was also diagnosed as having MERS, as was a 40-year-old man from Mecca who had no recent camel contact. The source of both infections is listed as "primary," meaning they likely did not contract the virus from another person.

The latest infections push Saudi Arabia's MERS-CoV total so far this year to 91, which includes 52 from Wadi ad-Dawasir, where cases have been tied to both healthcare and camel exposure.
Mar 5 MOH update


Lassa fever outbreak in Nigeria slows but includes almost 400 cases

For the fourth consecutive week, Nigeria has reported declining case counts in an ongoing Lassa fever outbreak. Despite the progress, 23 cases and 6 deaths were reported in the most recent week recorded (ending Feb 24).

According to an update from the World Health Organization's (WHO's) African regional office, the outbreak peaked at the end of January, when 77 confirmed cases with 11 deaths were reported. Between Jan 1 and Feb 25, a total of 396 cases and 86 deaths (case-fatality ratio, 21.7%) have been reported across the country.

Two of the most recent cases were in healthcare workers, bringing the total number of healthcare workers infected during the outbreak to 15. Sixty-three percent of the confirmed cases have been reported from the two most affected states—Edo (129 cases, 34%) and Ondo (110 cases, 29%).

The Nigeria Centre for Disease Control declared this outbreak an emergency on Jan 22. Lassa fever is endemic in Nigeria.

"The current Lassa fever outbreak in Nigeria is beginning to show an overall downward trend although it is very early to draw conclusions as the peak season for the disease is still not yet over," the WHO said.
Mar 3 WHO African regional report


WHO: Brisk flu continues in many Northern Hemisphere spots

Flu activity in temperate areas of the Northern Hemisphere continued to rise or remained high, with both influenza A viruses circulating and little influenza B detected so far, the World Health Organization (WHO) said yesterday in its latest global update, based on information up to Feb 17.

In North America, flu activity increased in the United States, decreased or peaked in some parts of Canada, and remained elevated in Mexico. Many European countries reported widespread flu, with high-intensity activity reported in six southwestern countries and hospitalization rates high in France and the United Kingdom.

Flu has peaked in some Western Asia countries, the WHO said, but is still rising in Cyrus and is still elevated in Kuwait and Saudi Arabia. In Eastern Asia, flu is declining in most countries but is still above seasonal thresholds in China and Hong Kong, with 2009 H1N1 as the dominant strain.

In tropical countries, flu levels are low in most locations, except for Southern Asia, with India and Bhutan reporting increased activity, mainly from the 2009 H1N1 strain.

At the global level, 98.6% percent of respiratory specimens that tested positive for flu were influenza A, and, of subtyped A strains, 65.2% were 2009 H1N1 and 34.8% were H3N2.
Mar 4 WHO global flu update

Stewardship / Resistance Scan for Mar 05, 2019

News brief

Study finds improper empiric therapy not tied to worse UTI outcomes

A University of Toronto study has discovered no connection between adequate empiric antibiotic therapy and cure time for patients with urinary tract infections (UTIs) caused by bacteria, suggesting a potential for sparing antibiotics, according to a study yesterday in Clinical Microbiology and Infection.

For the retrospective cohort study, the investigators enrolled all patients 16 years and older admitted to Sunnybrook Health Sciences Centre from Apr 1, 2000, to Jul 15, 2015 who had a first episode of bacteremic UTI. They then classified them as to whether they had adequate or inadequate antibiotic therapy within 24 hours of culture collection. They defined adequate therapy as receipt of at least one dose of an empiric antibiotic active in vitro against the infecting pathogen, based on lab-reported susceptibility tests.

The researchers noted that 368 (78.5%) of the 469 patients received adequate empiric antibiotic therapy. But they found no statistical difference between those patients and the patients who were prescribed inadequate empiric antibiotics in mortality, time-to-cure, or time-to-normalization.

The authors conclude, "Our findings add to a body of literature challenging the notion that early empiric therapy is necessary for good outcomes in patients with UTI." They add, "It may be appropriate to accept a higher risk threshold when choosing empiric antibiotic regimens, even in centres with high rates of resistant uropathogens."
Mar 4 Clin Microbiol Infect study


Surgery-linked resistant Pseudomonas from Mexico sickens 20 in 9 states

The World Health Organization (WHO) today said 20 adults in nine states have contracted antibiotic-resistant Pseudomonas aeruginosa after invasive procedures performed in Tijuana, Mexico.

Sixteen of the cases have been confirmed, the WHO said, and the rest are suspected. A confirmed case is defined as Verona integron-encoded metallo-beta-lactamase–producing carbapenem-resistant P. aeruginosa (VIM-CRPA) isolated from a patient.

On Jan 9, the US Centers for Disease Control and Prevention (CDC) issued a travel advisory over the cluster of infections but did not cite the number of cases or give many specifics. On Feb 13 the Public Health Agency of Canada followed suit in posting a travel advisory.

The WHO said in today's update that 2 of the 20 case were retrospectively identified and occurred in 2015 and 2017, but the other 18 infections occurred from Sep 5, 2018, to Jan 24, 2019. Fifteen patients reported having surgery, primarily for weight loss, at Grand View Hospital in Tijuana.

"Half of the total cases reported the use of the same medical tourism travel agency based in the United States to coordinate their surgical procedure in Mexico," the WHO said. The travel agency has referred patients to Grand View from the United States, Canada, and elsewhere.

Thirteen patients were hospitalized in the United States for complications associated with VIM-CRPA infections, and most had surgical-site infections. One patient who had a bloodstream infection and several underlying conditions died. Of the 17 patients with available information, 14 (82%) were female, and they ranged in age from 29 to 62 years.

The WHO says it will continue to monitor the situation.
Mar 5 WHO news release
Jan 10 CIDRAP News scan on CDC alert


Interventions fail to lower hospital-acquired infections except in subset

Two infection control practices for bacterial infections—including those caused by methicillin-resistant Staphylococcus aureus (MRSA)—failed to reduce hospital-acquired infections, except in patients being treated with medical devices, according to a very large study today in The Lancet.

The ABATE (Active Bathing to Eliminate) Infection trial, sponsored by the National Institutes of Health (NIH), evaluated whether daily bathing with the antiseptic soap chlorhexidine—and, in patients with MRSA, adding the nasal antibiotic mupirocin—more effectively reduced hospital-acquired bacterial infections than bathing with ordinary soap and water. Researchers enrolled 333,000 patients in 48 hospitals in the HCA Healthcare system for the 21-month study, which amounted to 1.3 million days of care.

Among all patients, the scientists found no statistically significant difference between the study arms. Patients with medical devices, however, such as central venous catheters or lumbar drains, benefitted from the chlorhexidine-mupirocin intervention. Among those patients, investigators recorded a 30% decrease in bloodstream infections and a nearly 40% drop in antibiotic-resistant bacteria, including MRSA and vancomycin-resistant enterococcus.

"The results of the ABATE Infection trial are already being incorporated into infection prevention efforts," Jonathan Perlin, MD, PhD, chief medical officer of HCA Healthcare and a study co-author, said in an NIH news release. "The HCA system is using this decolonization strategy as a best practice for patients with medical devices across our 179 affiliated hospitals."
Mar 5 Lancet study
Mar 5 NIH news release

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