FDA improves access to reports of adverse drug reactions


The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.

"Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA," said FDA Commissioner Scott Gottlieb, M.D. "The FDA is committed to fully informing patients and providers of adverse events reported with medical products and this enhanced portal now provides patients, doctors and others with easier access to the data they are interested in."

Province of Ontario Interim Report on ME/CFS, FM, and MCS/ES


“We found that, throughout the health care system and in society at large, there is:

•a lack of recognition of the seriousness and severity of these conditions
•a profound shortage of knowledgeable care providers
•a dearth of clinical tools to support and guide care
•a discouraging shortage of services and supports for people living with these conditions
•an absence of support for family caregivers.

The lack of knowledge and appropriate accessible care has devastating effects on Ontarians struggling with ME/CFS, FM and ES/MCS.

For those living with ME/CFS, FM and ES/MCS, the lack of recognition of these serious and debilitating conditions is as harmful as the lack of treatments. …

We urge the Minister to act now to raise awareness of these conditions and address the barriers that keep people with ME/CFS, FM and ES/MCS from getting the care and services they need.”

From the press release:


Release of Interim Report Looks at Hard-to-Diagnose Conditions

September 29, 2017

Ontario is releasing a report that recommends improving the understanding and recognition of environmental health conditions such as myalgic encephalomyelitis/chronic fatigue syndrome, fibromyalgia and environmental sensitivities/multiple chemical sensitivity.

The interim report, Time for Leadership: Recognizing and Improving Care, was produced by the Task Force on Environmental Health.

Its recommendations focus on three key areas:

research, education and care to improve supports for people in Ontario living with environmental health conditions.

The province is currently reviewing the task force’s recommendations and is renewing the funding for a fellowship in Clinical Environmental Health at the University of Toronto to expand clinical expertise in this domain.

The province also plans to provide support for a group of experts to develop consensus on clinical case definitions, to help health care providers and their caregivers better diagnose and understand these conditions.

The Struggle of Rare and Orphan Diseases


Ifyou scroll through databases of children and families who are part of the rare disease community, vague words like “unknown” and “undiagnosed” appear over and over again.

Alexander: Mitochondrial disease
Bertrand: Unknown lysosomal disease
Bethany: Undiagnosed
Connor: Rare chromosomal disorder
Eithene: Unknown genetic disorder

Some disorders are too rare for most physicians to have heard of them; others are completely new mutations.

Ambreen Sayed, a PhD student at the University of Maine’s Graduate School of Biomedical Science and Engineering who researches rare neuromuscular diseases, recalls her time interning in a hospital’s genetics department: “Nobody knew the name or proper treatment for a disorder affecting a particular child that was brought in, so the child couldn’t be effectively diagnosed or treated. I had always thought science treats everyone equally,” she says.

“That was one of the first instances where I was exposed to the fact that not every problem has a proper scientific name or definition, let alone people who want to work on the issue. That’s when I decided I wanted to work in the field of rare diseases,” says Sayed.

lthough each rare disease affects fewer than one in 1,000 individuals, they collectively affect one in every 10 Americans, according to the National Institutes of Health. A select few — such as cystic fibrosis, ALS, and Huntington’s disease — have gained attention and research funding through mass awareness efforts and celebrity involvement, but most of the 7,000 known rare diseases remain completely unfamiliar to the general population and much of the medical community.

Where pain lives

Fixing chronic back pain is possible only when patients understand how much it is produced by the brain, not the spine


or patient after patient seeking to cure chronic back pain, the experience is years of frustration. Whether they strive to treat their aching muscles, bones and ligaments through physical therapy, massage or rounds of surgery, relief is often elusive – if the pain has not been made even worse. Now a new working hypothesis explains why: persistent back pain with no obvious mechanical source does not always result from tissue damage. Instead, that pain is generated by the central nervous system (CNS) and lives within the brain itself.

I caught my first whiff of this news about eight years ago, when I was starting the research for a book about the back-pain industry. My interest was both personal and professional: I’d been dealing with a cranky lower back and hip for a couple of decades, and things were only getting worse. Over the years, I had tried most of what is called ‘conservative treatment’ such as physical therapy and injections. To date, it had been a deeply unsatisfying journey.

Like most people, I was convinced that the problem was structural: something had gone wrong with my skeleton, and a surgeon could make it right. When a neuroscientist I was interviewing riffed on the classic lyric from My Fair Lady, intoning: ‘The reign of pain is mostly in the brain,’ I was not amused. I assumed that he meant that my pain was, somehow, not real. It was real, I assured him, pointing to the precise location, which was a full yard south of my cranium.

Like practically everyone I knew with back pain, I wanted to have a spinal MRI, the imaging test that employs a 10-ft-wide donut-shaped magnet and radio waves to look at bones and soft tissues inside the body. When the radiologist’s note identified ‘degenerative disc disease’, a couple of herniated discs, and several bone spurs, I got the idea that my spine was on the verge of disintegrating, and needed the immediate attention of a spine surgeon, whom I hoped could shore up what was left of it.

Months would pass before I understood that multiple studies, dating back to the early 1990s, evaluating the usefulness of spinal imaging, had shown that people who did not have even a hint of lower-back pain exhibited the same nasty artefacts as those who were incapacitated. Imaging could help rule out certain conditions, including spinal tumours, infection, fractures and a condition called cauda equina syndrome, in which case the patient loses control of the bowel or bladder, but those diagnoses were very rare. In general, the correlation between symptoms and imaging was poor, and yet tens of thousands of spinal MRIs were ordered every year in the United States, the United Kingdom and Australia.

Very often, the next stop was surgery.  For certain conditions, such as a recently herniated disc that is pressing on a spinal nerve root, resulting in leg pain or numbness coupled with progressive weakness, or foot drop, a nerve decompression can relieve the pain. The problem is that all surgeries carry risks, and substantial time and effort is required for rehabilitation. After a year, studies show, the outcomes of patients who opt for surgery and those who don’t are approximately the same. 

More Evidence that Dementia Case Numbers Are Falling


Numerous studies have reported a dip in dementia incidence in the developed world. When did this trend begin? In the September 5 JAMA Neurology, researchers led by Carol Derby at Albert Einstein College of Medicine in New York help address this. The researchers analyzed birth cohort data from the Einstein Aging Study, which enrolls cognitively healthy older adults living in the Bronx. Surprisingly, people born after 1928 were 85 percent less likely to develop dementia than those born before that year. The reason for such a stark drop in incidence is unclear. Neither better education nor improved cardiovascular health accounted for the effect.

A growing number of studies have reported a drop in dementia incidence in the U.S. and Europe over the last two or three decades (e.g., Feb 2016 newsApr 2016 newsNov 2016 news). Researchers have speculated that this may be due to better public health, particularly cardiovascular health (May 2013 newsJul 2014 conference news). The finding is not uniform, however, with a handful of studies reporting higher dementia incidence that may be due to greater recognition of the disease or a larger number of people reaching old age (Mar 2017 newsMay 2017 newsAbdulrahman 2014). 

“Changes in diet, especially for the mother during pregnancy, may be a crucial factor,” agreed Walter Rocca at the Mayo Clinic in Rochester, Minnesota. In addition, Rocca pointed out that people born in 1929 or after would have been teenagers or younger at the end of World War II, and thus their developing brains may have particularly reaped the benefits of the societal and medical changes that occurred at that time (see full comment below).

While previous epidemiological studies did not specifically examine birth years, those older findings are roughly congruent with the Einstein Aging Study data, reporting the greatest drop in dementia cases after 1990, the authors noted. People born after 1929 would have entered their 60s in that decade. Most cases of late-onset dementia occur after age 60. The Rotterdam Study found a 25 percent decrease in dementia incidence in the 1990s, while the Framingham Heart Study recently reported that incidence dropped starting in the late 1980s and continued to decline into the 2010s (Schrijvers et al., 2012Satizabal et al., 2016). 

Controlling blood pressure with fewer side effects

Interesting approach. Undermines the standard approach of pharmacy companies to view each drug as a separate profit center....


Approximately one in three Americans has high blood pressure, but only about half of those who do have the condition under control. One common reason: they stop taking their medications, often because of troublesome side effects such as weakness, fatigue, or a dry cough. However, taking smaller doses of several different blood pressure drugs may be a good way to address these issues, a new analysis suggests.

Researchers found that taking a quarter-dose of a two-drug combination was just as effective at lowering blood pressure as taking a full dose of one drug. Taking a quarter-dose of a four-drug combination was even more effective (although it's important to note that this finding came from a single, small trial). People who took smaller doses of multiple drugs had fewer side effects than those taking a single drug at the full dose. In fact, their side effects were similar to those of people who took placebos. The study was published in the July 2017 issue of Hypertension.

Disabled Iowans could be exempted from private Medicaid management


Iowa might resume direct oversight of care for people with serious disabilities instead of having private Medicaid-management companies continue doing it, the state’s human-services director said Wednesday.

Many of the most serious complaints about Iowa’s privatized Medicaid system have come from disabled Iowans and their families. Numerous families have reported having their services cut and their hassles multiplied by the management companies. Their plight has sparked a federal lawsuit against the state.

“We are examining patients that may not be the right mix” for managed care-companies to oversee, Department of Human Services Director Jerry Foxhoven told an advisory council for his agency Wednesday.

Foxhoven, who recently became the department’s director, said the Medicaid management companies could succeed at saving money by helping many other Iowans improve their health, such as by encouraging them to quit smoking. “But somebody who’s a quadriplegic and is on a ventilator, there’s probably not much you’re going to do to improve their health or bring costs down,” Foxhoven told the Council on Human Services.

Iowa shifted last year to having three private companies manage its Medicaid program, which covers health care for nearly 600,000 poor or disabled Iowans. The change has been intensely controversial, especially in regards to how it has affected care for Iowans with serious disabilities.

Foxhoven raised the possibility of exempting some recipients from managed care during a discussion Wednesday of extended negotiations over new payment rates for the for-profit management companies. Those new rates were supposed to take effect July 1. The management companies have been demanding more money, saying they’ve lost hundreds of millions of dollars on the project.

Senate Finance Committee Leaders Agree to Five-Year CHIP Extension


With funding for the Children’s Health Insurance Program (CHIP) nearing its expiration at the end of September, Senate Finance Committee leaders have announced a bipartisan proposal to reauthorize funding for the program for five years. Formal legislation has not yet been released, but Chairman Orrin Hatch (R-UT) and Ranking Member Ron Wyden (D-OR) have committed to help move the proposal through Congress this month. An identical proposal must also pass the House and be signed by President Trump. 


A program with bipartisan support, CHIP currently provides affordable, comprehensive health coverage to roughly 9 million children and pregnant women who do not qualify for Medicaid, but whose families cannot afford other forms of health insurance. Since CHIP’s inception in 1997, the uninsured rate of children from ages 0 to 17 dropped from 13.9 percent that year to 4.5 percent in 2015. CHIP is currently funded in part by states, who receive federal funds at specific matching rates, much like Medicaid. 

Under the Affordable Care Act (ACA), the federal match rate for CHIP was increased by 23 percent to help incentivize states to expand their coverage programs for children. The current federal match for CHIP is set to expire after September 30, which would leave states with limited funds to continue administering the program if no deal is reached. 

Senate Finance Committee Chairman Orrin Hatch (R-UT) and Ranking Member Ron Wyden (D-OR) announced their proposal on Wednesday in hopes to ensure stability for states by extending federal funding for CHIP for five years. To reach a bipartisan agreement, the current proposal would reduce the increased 23 percent match rate over the life of the extension, dropping to 11.5 percent in 2020, and eliminating the increase by 2022.

“I Can Take Care of Myself!”: Patients’ Refusals of Home Health Care Services


When patients who have been discharged from inpatient care refuse home health care services, they may experience higher rates of readmission to the hospital and a lower quality of life. This issue is not well studied or understood, and in December 2016 UHF’s Families and Health Care Project and the Alliance for Home Health Quality and Innovation sponsored a roundtable examining it. This report summarizes the discussion and findings of that roundtable.

The report also contains a number of recommendations, among them interventions that improve communication about care challenges and home health care services, qualitative and quantitative research on all aspects of home health care refusals, policy changes to increase access and coordination, and continuity across providers and care settings.

Read the press release.

Published: 05.15.2017