FDA Warning for Obesity Devices: Intragastric Balloons

FDA Warning: Five Die While Using Obesity Devices (Intragastric Balloons)

An excerpt:

At least five people have died soon after being fitted with balloons aimed at helping them lose weight, the Food and Drug Administration said Thursday.

The FDA says it doesn’t know if the devices or the surgery to implant them is to blame but issued an alert to doctors to closely monitor patients who get them.

Related blog post: In the News: Weight Loss Intragastric Balloons

One in Three Americans Used Prescription Opioids in 2015

NBC News: One in Three Americans Took Prescription Opioid Painkillers in 2015

An excerpt: How many Americans are using prescription opioid painkillers? About one in three.

That’s the stunning number in a new survey released Monday from the National Institute on Drug Abuse, which calculated that a whopping 91.8 million Americans used drugs like OxyContin or Vicodin in 2015.

And nearly five percent of the adults surveyed told researchers they took these drugs without their doctor’s permission, the study reported.  They didn’t get their meds from some seedy drug dealer, either.

“The most commonly reported sources were friends and relatives for free,” the study reported. “Or a physician.”

Surgery as Placebo

A recent summary by 538 website details how surgery can be a powerful placebo: Surgery Is One Hell of a Placebo

Here’s an excerpt:

“expectations matter, and we know they matter because of a bizarre research technique called sham surgery. In these fake operations, patients are led to believe that they are having a real surgical procedure…

2014 review of 53 trials that compared elective surgical procedures to placebos found that sham surgeries provided some benefit in 74 percent of the trials and worked as well as the real deal in about half.1 Consider the middle-aged guy going in for surgery to treat his knee pain. Arthroscopic knee surgery has been a common orthopedic procedure in the United States, with about 692,000 of them performed in 2010,2 but the procedure has proven no better than a sham when done to address degenerative wear and tear, particularly on the meniscus

Even without a robust placebo effect, an ineffective surgery may seemhelpful. Chronic pain often peaks and wanes, which means that if a patient sought treatment when the pain was at its worst, the improvement of symptoms after surgery could be the result of a condition’s natural course, rather than the treatment. That softening of symptoms from an extreme measure of pain is an example of the statistical concept of regression to the mean.

My take: Both with medicine and surgery, sometimes improvement occurs even when the treatment itself is not effective.

Dupont Forest, NC

“Sell by”/Expiration Dates for Medications

A recent NPR story/ProPublica research reiterates the fact that many medications remain potent long after their expiration dates: That Drug Expiration Date May be More Myth Than Fact

Here’s an excerpt:

Tossing such drugs when they expire is doubly hard. One pharmacist at Newton-Wellesley Hospital outside Boston said the 240-bed facility is able to return some expired drugs for credit, but had to destroy about $200,000 worth last year. A commentary in the journal Mayo Clinic Proceedings cited similar losses at the nearby Tufts Medical Center. Play that out at hospitals across the country and the tab is significant: about $800 million per year. And that doesn’t include the costs of expired drugs at long-term care pharmacies, retail pharmacies and in consumer medicine cabinets…

Pharmacists and researchers say there is no economic “win” for drug companies to investigate further. They ring up more sales when medications are tossed as “expired” by hospitals, retail pharmacies and consumers despite retaining their safety and effectiveness…

Whatever the solution, the drug industry will need to be spurred in order to change, says Hussain, the former FDA scientist. “The FDA will have to take the lead for a solution to emerge,” he says. “We are throwing away products that are certainly stable, and we need to do something about it.”

My take: Don’t expect any action on this issue anytime soon.  At the very least, this will may persuade some family members not to throw away some medications that are likely still effective.

“March of Science”

A fascinating commentary (“The March of Science –The True Story”  L Rosenbaum NEJM 2017;377: 188-91) discuss issues regarding mistrust of science in this age of ‘alternative facts.”

Here are some key points:

  • “Nutrition science may be the area that provides the most ammunition for distrust, given the combination of uncertainty, public interest, and powerful preferences. Indeed, skepticism of most nutrition science is warranted, given the often insurmountable challenges of controlled, blinded experimentation…The confluence of these factors..often invoked to condemn the scientific process more generally: Why should I believe you people when you people are always changing your minds?”
  • “Remarkable gains in human longevity are just one manifestation of science’s success–but….’No one wants to hear about the plane that lands.'”
  • There has been a shift “in the tone of public discussions of science.” Instead of someone being “wrong,” they are now “corrupt” or “evil.”
  • Due to potential for condemnation, there is fear of “venturing into the fray” which “means that the public hears far more from science’s critics than its champions. This imbalance contributes to “science is broken” narratives ranging from claims about the pervasiveness of medical error to the insistence that benefits of our treatments are always overhyped.
  • Changing the narrative: “we have to learn to tell stories that emphasize that what makes science right is the enduring capacity to admit we are wrong. Such is the slow, imperfect march of science.”

My take: Widespread skepticism and confirmation bias have the potential to disrupt highly effective medical treatments by confusing them for those that are unproven.

Related blog posts:

Dupont Forest, NC


Understanding the Health Care Fight

From Axios: This is what Washington has been fighting about

An excerpt:

Every time you hear the Trump administration or Congress fight about rising Affordable Care Act premiums, or what will happen to people with pre-existing conditions, just remember — we’re talking about issues that affect 7 percent of the population. That’s how many people are in the individual health insurance market, or the “non-group” market…

But when you hear about those sky-high rate hikes because of “Obamacare,” chances are, they’re not your sky-high rate hikes — unless you happen to be in that market…

The spending limits that have been proposed for Medicaid really do matter, and they affect a larger group — 20 percent of the population. 

Diarrhea Mortality Improving

A  recent story from NPR indicates that globally diarrhea deaths are on the decline, ~30%, from 2005-2015.  In wealthy countries, there has been a mild increase, likely related to Clostridium difficile infection and the use of antibiotics.  The article cautions that data from some parts of the world are questionable due to upheaval.

Full Link: A Good News Story About Diarrhea -With One Surprising Exception

An excerpt:

An infection by E. coli, Cryptosporidium, Shigella or rotavirus, and the resulting diarrhea, is often a death sentence in much of the world. In 2005, about 1.6 million people died from diarrhea-related diseases, and roughly 770,000 of them were kids under 5. But that number has been steadily dropping, as a new study points out…

Published this month in The Lancet, the study shows diarrhea-related deaths have declined about 20 percent from 2005 to 2015 for all ages to 1.3 million people, and 35 percent for children under 5 to about 500,000 children during the same time period.