Nysha Recent News

Health News

June 17, 2016

By Mendy Hecht, Hamaspik Gazette

With simpler FDA form, more access to experimental drugs

Doctors whose patients have incurable illnesses will now have easier and quicker access to experimental drugs, thanks to a newly simplified FDA “compassionate use” form.

Under the FDA’s so-called compassionate use policy, experimental drugs can be used by doctors for non-intended uses that are not approved by the FDA.  But compassionate use can only be invoked where doctors have exhausted all other treatment options.

Until now, physicians had to fill out a 26-question application form.  The new form has only 11.

However, doctors still must first get authorization from drugs makers, and the FDA can’t force them to grant permission.  What’s more, drug makers might reject requests for fear of lawsuits due to side effects, or because their experts disagree with patients’ doctors. 

Experts note that most failed requests end with rejections from drug makers, not the FDA.  However, where drug makers approve compassionate-use requests, 99 percent of applications to the FDA in the past six years were approved.  Records also indicate that only 14 out of 1,430 applications were rejected in fiscal-year 2015.

Zika experiment gives researcher Zika

It was reported in early June that a University of Pittsburgh laboratory researcher gave herself the Zika virus on May 23 while conducting an experiment on the Zika virus. 

The worker accidently pricked herself mid-experiment with a Zika-bearing needle. 

Symptoms—which include mild fever, rash and red eyes—appeared on June 1 and were gone five days later, at which point the researcher returned to work.

While the Zika virus currently has no vaccine or treatment, an estimated 80 percent of those infected have no symptoms.

Poor lung function still plaguing 9/11 responders: study

An ongoing study of 10,000 New York City firefighters and other “Ground Zero” first responders finds that they still suffer poor lung function 15 years after the 2001 terror attack.

The study found that over 90 percent of responders developed acute coughs in the days and months following 9/11, and that over 50 percent developed persistent respiratory symptoms.

The study is especially scientific because New York City firefighters have their lungs tested regularly.  Researchers were able to use that data to compare their lungs before and after 9/11.  The research is the longest study of lung function ever undertaken in rescue/recovery workers following a major environmental disaster.

The study also found that quitting smoking dramatically improved responders’ lung health.

The study by Montefiore Medical Center and Albert Einstein College of Medicine was published recently in the medical journal CHEST.

Smokers quit up to 30 times

Mark Twain is said to have said, “Quitting smoking is easy!  I’ve quit one thousand times.”

But now, a data review of 1,277 adult lifetime smokers by the University of Toronto’s school of public health says that most smokers actually try close to 30 times before finally succeeding.

Conventional wisdom says it takes five to seven attempts for most smokers to quit.

The study defines “quit attempt” as going without a cigarette for an entire year—meaning that, for many smokers, trying to quit close to 30 times means taking close to 30 years to really quit.

The study was published in BMJ Open.

Report: 2017 medical costs stable

A new report by healthcare consultancy PwC says that Year 2017 will see the same amount of growth in medical costs as that of Year 2016—6.5 percent, to be exact. 

According to PwC, while medical costs have grown since 2007, the rates of growth have actually dropped since 2007.  In plain English, annual medical costs have grown less than each previous year since 2007.

For example, while 2007 saw an 11.9-percent growth in costs of medical care, 2008 only saw a 9.8-percent growth.

That number has kept dropping each year to 2014’s 6.5-percent rate, where annual growth in costs of medical care has essentially flat-lined since.

The report also says that “price, not utilization, is the force behind historical medical cost trend”—meaning that it’s the growing cost of care, not a growing number of people using a growing amount of doctors, tests, procedures and so on, that’s making healthcare costlier.

The report also breaks down employer health costs: Roughly half, according to PwC, are from hospital inpatient (30 percent) and outpatient (19 percent), while doctor visits account for about 30 percent, and prescription drugs another 17 percent.

Opioid prescription painkillers over-supplied, under-managed, shared

A study of over 1,000 adults by the Johns Hopkins Bloomberg School of Public Health finds that the public prescribing and management of opioid painkillers is poorly managed.

The study found, for example, that over half—six out of ten—of adults on opioid painkillers like OxyContin or Vicodin were given too many pills in their prescriptions, keeping them for “future use.”  Close to half said that they were not properly instructed on how to dispose of these extras.

Over one in five study participants also admitted to sharing excess pills with family and friends, primarily to help them manage pain.

Researchers say that these patterns are contributing to the nation’s ongoing epidemic of prescription painkiller abuse.  According to the CDC, fatalities from prescription opioids more than tripled between 1999 and 2014.

The findings appear in the June 13 issue of JAMA Internal Medicine.

Culinary kickback?

A study of interactions between Big Pharma sales reps and physicians finds that doctors given as little as one sandwich or restaurant lunch prescribed brand-name drugs more than equivalents.

The study scrutinized public data on leading drugs in four categories: AstraZeneca’s cholesterol-lowering Crestor; Allergan’s Bystolic for heart rhythm disorders; Daiichi Sankyo’s Benicar for high blood pressure; and Pristiq, an antidepressant by Pfizer.

All four have equally effective alternatives, in the form of generic versions of competing drugs.  For example, Lipitor, another anti-cholesterol drug, has a generic that works just as well.

The study found that relatively few doctors who prescribed those specific drugs had gotten food “payments” from sales reps—but found that those who did prescribed those drugs more often.

Specifically, doctors getting free lunches prescribed Crestor at nearly twice the rate as “hungry” doctors.  Doctors fed by Bystolic’s makers prescribed that drug five times more than those not.

Doctors given food by Benicar reps prescribed that drug 4.5 times more than its generic equal, while those “treated” by Pristiq reps prescribed that drug 3.4 times more than its generic equal.

The small meals paid for by drug companies cost less than $20 on average.

The study drew on data required to be made public since 2013, in part, by the Affordable Care Act (ACA), as well as by the 2002 adoption of a voluntary code by the Pharmaceutical Research and Manufacturers of America (PhRMA) that governs member dealings with doctors. 

While that code states that companies shouldn’t provide event tickets or vacation trips to any non-employee professional, it does allow for providing simple meals to doctors.  As such, sales reps are known to regularly bring free food to doctors’ offices.

However, “There’s really no way that a $10 bagel sandwich can influence a doctor in a gift way,” said researcher Dr. Colette DeJong of UC San Francisco.  “We think it represents more reciprocity, the time spent with the drug rep and the fact that the doctor is listening to this ten-minute pitch.”

Fellow researcher Dr. R. Adams Dudley concurred.  I don’t think there is a doctor out there who thinks, ‘I can be bought for a slice of pizza,’ ” Dr. Dudley told The New York Times. 

Additionally, the study “cherry-picks physician prescribing data … to advance a false narrative,” PhRMA spokesperson Holly Campbell wrote in an email to the Times.  

The study is also questionable because researchers acknowledge that they couldn’t figure out if the drugs were prescribed before or after doctors got food and drink paid for by drugmakers.

The study was published June 20 in JAMA Internal Medicine.

Obamacare, IRS to enroll more young people next year

It may be four months until the next open-enrollment period for the Affordable Care Act (ACA)’s marketplace” healthcare plans—but the U.S. Dept. of Health and Human Services (HHS), which governs the plans, is already gearing up to enroll more young people than ever—and, ultimately, control and even bring down plan prices.

Modern healthcare has long been plagued with increased usage by older and unhealthier people and decreased usage by younger, healthier people.  The resulting increased prices and decreasing customer base is known in the industry as the death spiral.

With an eye toward stabilizing and even lowering prices, the HHS announced on June 21 that it would be working with the IRS to target young people who reported no healthcare coverage in their 2015 tax returns.  Among the ACA’s most controversial innovations is the individual mandate, which legally requires U.S. taxpayers to report healthcare coverage or pay an IRS fine.

In the run-up to the coming Nov. 1, 2016-Jan. 31, 2017 open-enrollment period, both federal agencies will be contacting individuals who paid a penalty or claimed an exemption in 2015.

In 2014, according to the HHS, 7.9 million people paid the penalty for not having coverage, with about 45 percent being under the age of 35.  “Young adults are over-represented among those who paid the fee,” the agency said in a news release.

The agency will also begin to more aggressively target 26-year-olds whose insurance through their parents—another Obamacare innovation—is ending.

On the other hand, about 28 percent of people who signed up for marketplace coverage last year were between 18 and 34, but HHS wants to increase that share as moving healthier/younger people into the exchanges will help keep premiums low.


SUMMER KIDS’ SAFETY TIPS

  1. Check those back seats!  A car with closed windows parked in direct sunlight can heat up to 170 degrees inside in 15 minutes.  Never leave a child in a car—even for a minute!

  2. Watch that water!  Swimming is a family sport—even if you’re not getting in.  Kids MUST have parents or adults there—and playing with them, not reading or on the phone.

  3. Learn CPR!  It’s easy, it is free in many places, and it could easily save a life.