California Wildfires

Studies
Wildfire Exposure Increased ER Visits for Stroke and Heart Attack

A study published in the Journal of the American Heart Association reviewed more than 1 million visits to emergency rooms during the 2015 northern California wildfires. The wildfires, which took place from May 1 to September 30, 2015, burned more than 800,000 acres and caused a spike in heart attacks and stroke.

Researchers discovered a 42% increase in emergency room visits for heart attacks and a 22% increase in visits for heart disease, mostly affecting seniors during the heaviest days of burning.

Chronic obstructive pulmonary disease and asthma are two of the more common respiratory illnesses related to California wildfire exposure, whereas ischemic stroke, heart failure and myocardial infarction (MI) occurred but were less common.

These cardiovascular and respiratory illnesses are caused by air pollutants like ozone, carbon monoxide, polycyclic aromatic compounds and nitrogen dioxide. Insights from this study could potentially shed light on complications that occurred after the October 2017 California wildfires, which destroyed thousands of homes, neighborhoods and businesses.

 

Blood Clot Filters

Legal Developments
Women Awarded $3.6 Million for C.R. Bard Blood Clot Filter Complications

Sherri Booker, a woman with a C.R. Bard IVC filter, received $3.6 million for a plethora of injuries related to a common medical device. Booker, who had an blood clot filter implanted in June 2007, was hospitalized in 2014 because of serious complications.

IVC filters have been linked to a number of issues. In Booker’s case, the IVC filter fractured, tilted and migrated, causing the device to perforate her essential inferior vena cava vessel. Though her physicians attempted to remove the IVC filter, parts of the device remain in her body.

The $3.6 million case is the first to take place in Arizona, but there are thousands of cases are still pending. An estimated 3,639 lawsuits are included in a Phoenix in multidistrict litigation related to C.R. Bard’s IVC filters. There are an additional 3,826 cases related to Cook Medical IVC filters pending in Indiana.

 

Diabetes

Regulations 
FDA Approves Artificial Intelligence To Detect Diabetes-Related Vision Loss

The U.S. Food and Drug Administration has approved a device that uses artificial intelligence to detect diabetic retinopathy, a form of vision loss that may lead to blindness. The IDx-DR is now able to be used for early detection of “more than mild” retinopathy.

“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50% of them do not see their eye doctor on a yearly basis,” according to a statement from Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health.

Before approving the device, the FDA reviewed a clinical trial that included 900 diabetic patients seeking treatment at ten primary care locations. The research showed the IDx-DR could detect more-than-mild cases of diabetic retinopathy 87.4% of the time. The device was also able to show there was no presence of more-than-mild diabetic retinopathy 89.5% of the time.

Intended for use during routine visits, the device allows physicians to refer people with diabetes to an eye care professional for timely evaluation and treatment.

 

Xarelto

Regulations 
Xarelto Bleeding Antidote, AndeXxa, May Be Further Delayed

Portola Pharmaceuticals Inc., the company which spearheaded the creation of the AndexXa reversal agent that works as an antidote to Xarelto bleeding, may have to conduct another clinical before the drug can enter the market.

AndexXa is a Factor Xa inhibitor, used to reverse the extreme bleeding side effect linked to Xarelto. In August 2016, AndexXa was initially rejected, which delayed the drug’s launch. Portola resubmitted the drug after one year, with additional information.

“[T]he request that’s been made require[s] a randomized clinical trial, and then the expectation that we would have discussions over the review period,” according to Portola CEO William Lis.

Since the delay, Portola’s stock fell almost 25% and caused a lot of upset for company investors. However, delays in the approval of new drugs and devices are essential to ensuring medications are safe for a majority of the population. Portola has yet to change the expected launch date for AndexXa, which is currently scheduled for May.

 

Opioids

Regulations 
Research Shows Reduced Opioid Prescriptions in States with Medical Cannabis

Studies show states with legalized medical cannabis have experienced a decline in opioid prescriptions. This is significant because rates of death linked to opioids have risen massively since 1999, and medical marijuana may be a way to help ease the personal and collective burden of the U.S. opioid crisis.

Recently published in JAMA Internal Medicine, the two studies continue the debate surrounding the claim that medical cannabis can positively reduce the use of opioids. Opioid prescription rates were 8.5% lower for Medicare Part D patients in states with medical cannabis. More specifically, states with existing dispensaries had 3.742 million fewer daily doses filled, while states that allowed only home cultivation had 1.792 million fewer supplied daily doses.

Currently, 29 states and the District of Columbia have enacted medical marijuana laws. When state medical cannabis laws went live, opioid prescriptions under Medicare Part D dropped by 2.21 million daily doses per year, according to W. David Bradford, Ph.D., of the University of Georgia.

Empirical evidence from the period between 2011 and 2016 showed that medical cannabis may be linked to lower prescribing rates for people enrolled in Medicaid programs, which is considered a high-risk population for chronic pain, overuse and overdose, according to MedPage Today. Though no policy-related conclusions have been drawn, other studies have shown medical cannabis laws may have a mean 24.6% lower annual opioid overdose mortality rate.