Most Recent Posts

Certain foods are supposed to be spheres: Cocoa Puffs; gum balls; eggs (if your chicken is broken). The folks at Welch's have spherified the peanut butter and jelly sandwich, and if they're allowed to do that, we're allowed to make up the word spherified.

Ian: It looks like they came out of a PB&Rabbit.

Miles: Finally, a way for me to shove an entire sandwich in my mouth without attracting unwanted attention.

i i

Actually, reading the ingredients, it's not a PB& J, it's a FC, WG, PASP, S, CS, MCS, CA, SC, SF, C6H8O6, P, AT, A, VAP, S, PK, PO, PF, NM, WP, PB, S, SL, CO, CW, & CG. NPR hide caption

itoggle caption NPR

Actually, reading the ingredients, it's not a PB& J, it's a FC, WG, PASP, S, CS, MCS, CA, SC, SF, C6H8O6, P, AT, A, VAP, S, PK, PO, PF, NM, WP, PB, S, SL, CO, CW, & CG.

NPR

Robert: I'm all for chefs deconstructing familiar foods to make something all new, but my daughter wadded up her PB&J into little pellets just like this when she was 3.

Ian: They look like a health-food version of whatever the Hungry Hungry Hippos were eating.

Miles: I like these better than the Tuna Salad Spheres you brought in last week.

i i

Miles considers developing a peanut allergy until this lunch is over. NPR hide caption

itoggle caption NPR

Miles considers developing a peanut allergy until this lunch is over.

NPR

Ann: My next Valentine's card: we go together like peanut butter and jelly bite-sized balls.

Ian: Mmmm, just like mom used to process.

Miles: Kids who have this packed in their lunch also get a note that says, 'I'm just not that into you. Sincerely, Mom.'

i i

Robert took the elementary school lunch thing all the way. Maybe this time he'll graduate! NPR hide caption

itoggle caption NPR

Robert took the elementary school lunch thing all the way. Maybe this time he'll graduate!

NPR

[The verdict: 4/5ths of us hated them, 1/5th of us is me.]

Sandwich Monday is a satirical feature from the humorists at Wait Wait ... Don't Tell Me!

Sandwich Mondays

peanut butter

When medical device entrepreneur Joe Kiani announced his commitment to eliminating medical mistakes, he did it with panache. His medical device company, Masimo Corporation, funded the launch of a nonprofit called the Patient Safety Movement Foundation. And at its flashy inaugural summit in 2013 – featuring former President Bill Clinton as the keynote speaker – Kiani pledged to galvanize the medical industry to reduce the number of deaths from medical errors across the country from hundreds of thousands a year to zero.

"Of all the dreams I've had none seem as important as this dream: The dream of no more preventable patient death," Kiani said to the gathering of health care leaders.

Now people will see whether Kiani, and his company, Masimo, walk the talk. Keeping patients safe requires device makers to respond appropriately to complaints. But an inspection by the Food and Drug Administration last year found Masimo didn't adequately investigate dozens of reports that its devices may have malfunctioned.

The FDA didn't find that Masimo's devices were defective, but rather that the company wasn't sufficiently looking into that possibility. The inspection report was obtained by ProPublica via public records request.

With over $500 million in annual sales, Masimo is one of the leading makers of noninvasive pulse oximeters — patient monitoring devices that track pulse and blood oxygen, often clipped gently onto fingers or toes. Doctors in emergency rooms and intensive care units rely on the monitors to alert them when a patient has abnormal readings. If the devices give inaccurate readings or fail to alert doctors to drastic changes in a patient's vital signs, doctors could misdiagnose or fail to recognize the severity of a patient's condition, which could lead to injury or death.

The complaints identified in the FDA inspection varied. In one case a patient suffered a burned toe, and in another there was a question about whether an alarm properly sounded before a patient died.

If a patient or health care provider sees a problem with one of Masimo's products they can report the problem to the company, which is then required by law to investigate. If the device malfunctioned or was implicated in a patient injury or death, the company must in turn disclose that to the FDA.

After the agency's inspection last year, Masimo disputed the FDA conclusions, saying the agency had misunderstood the circumstances surrounding each complaint. But after nearly a year of review, the FDA stuck to its findings. It reprimanded the company with an official warning letter this August, stating that Masimo was still not adequately responding to complaints about its devices.

FDA warning letters aren't common – it's the first Masimo has received in its 25-year history. They are generally reserved for significant violations that could result in an enforcement action, such as fines or a recall. The agency declined to offer further comment.

Diana Zuckerman, an expert on medical devices and president of the National Center for Health Research, reviewed the FDA's findings and Masimo's response at ProPublica's request. She said it appears that Masimo is "not taking the care to investigate their own possible malfunctions."

Since patients or doctors often don't report problems with products, Zuckerman said, complaints that are filed are "always the tip of the iceberg." Zuckerman added that she found it striking that Masimo disputed most of the complaints and "particularly troublesome" that the company challenged a complaint that involved questions about whether a Masimo device properly set off an alarm before a patient died.

"It may well be that it's a user error," Zuckerman said. "But you have to investigate that and show that it's a user error and not a device error."

Zuckerman found it striking that the company refused to admit any wrongdoing to the FDA. "When a company refuses to respond in any way to the FDA other than to say that the FDA is wrong on every issue, that's not very credible," Zuckerman said. "Especially when users made complaints that the company's product put patients at risk," she said.

In an interview with ProPublica, Kiani again disputed the FDA's findings, saying Masimo has always followed up on complaints. He said the company is cooperating with the regulator, providing it with information "to show them we did nothing wrong."

When asked how the FDA findings reflect on the ideals put forth by his nonprofit effort, the Patient Safety Movement Foundation, Kiani said that he never claimed to be perfect. "I'm just trying to do my best and get my other colleagues to do their best, and put processes in place to hopefully minimize preventable death," he said.

The two-year-old foundation has attracted a who's who of top health care quality experts to its summits, including decision-makers from Medicare. The second annual conference was in January at the Ritz Carlton Hotel in Laguna Nigel, Calif.

The foundation promotes a "culture of safety" and encourages the early identification of problems that can lead to patients being harmed. "The lack of safety culture results in concealment of errors and therefore a failure to learn from them," the foundation's guidelines state.

One member of the foundation's board said he was disappointed about Masimo's alleged lack of response. Masimo "has to improve because [companies] are a big part of our ability to get to zero preventable harm," said the board member, Dr. David Mayer, also a vice president of quality and safety at Medstar Health in Maryland. Mayer said he gets no compensation to sit on the board and pays his own expenses to attend its meetings.

The foundation's president, Jim Bialick, said the organization is primarily funded by a charitable offshoot of the company, the Masimo Foundation for Ethics, Innovation, and Competition in Healthcare.

In response to a question about whether the FDA's concerns would be addressed at the upcoming summit, Bialick said that was Masimo's choice. "I would imagine it would come up. Whether Masimo brings it up, that's up to them."

ProPublica is a nonprofit investigative reporting newsroom based in New York.

medical errors

Medical Devices

ProPublica

i i

Protesters near the government headquarters in Hong Kong on Monday. Pro-democracy protests in Chinese-controlled Hong Kong appeared to be subsiding as students and civil servants returned to school and work after more than a week of demonstrations. Carlos Barria/Reuters/Landov hide caption

itoggle caption Carlos Barria/Reuters/Landov

Protesters near the government headquarters in Hong Kong on Monday. Pro-democracy protests in Chinese-controlled Hong Kong appeared to be subsiding as students and civil servants returned to school and work after more than a week of demonstrations.

Carlos Barria/Reuters/Landov

The number of pro-democracy protesters in Hong Kong has dwindled today after a weekend that saw dozens of arrests and an angry backlash from business owners whose shops were shut down amid the demonstrations.

The South China Morning Post says: "protest sites are quiet on Monday as some demonstrators leave for work, others remain and authorities keep their distance."

And, The Associated Press notes: "The subdued scenes left many wondering whether the movement, which has been free-forming and largely spontaneous, had run its course - or whether the students have a clear strategy about what to do next."

The BBC refers to "hundreds" of demonstrators still on the streets in three main protest areas where there had been thousands or tens of thousands last week. The news agency says civil servants were returning to the government's headquarters, which had been blocked for days by the protests.

"The BBC's Juliana Liu in Hong Kong says the protesters appear to have decided to beat a strategic, possibly temporary, retreat - partly out of sheer exhaustion, as the demonstrations entered their second week.

"She says activists have been encouraged by news that student leaders have begun meeting government officials to lay the groundwork for talks on political reform."

Those talks, first agreed to last week, were quickly called off amid violence from what students claimed were government-sponsored counterdemonstrators.

Although the talks appear to be back in play, NPR's Anthony Kuhn, reporting from Hong Kong, says the two sides have failed to agree on the details.

"The protesters say they will stick to their demands for political reforms and free elections," Anthony says. "They also want the police to protect them from the counter-demonstrators."

The territory's top leader Leung Chun-ying says the demonstrators must allow schools and government offices to reopen on Monday," Anthony says.

At a Monday afternoon briefing, police spokesman Hui Chun-tak said 37 arrests had been made in Kowloon's crowded Mong Kok distract and that "[another] 5 arrests were made in relation to suspected cyber crimes, in a case where a link was posted online for people to hack government websites with," according to the SCMP. The arrests came after police threatened to take "all measures necessary" to break up the protests.

Hong Kong protests

China

Of all the issues in all the congressional races this fall, none may be more personal than gun violence in Arizona's 2nd District.

That's the seat Democrat Gabrielle "Gabby" Giffords held until she resigned after being shot in the head three years ago.

Her then-district director, Ron Barber, was also wounded in that mass shooting, and went on to succeed her in Congress. Now, Barber is locked in a rematch of a tight 2012 contest, and Giffords' presence has suddenly become controversial.

Giffords and her husband, Mark Kelly, are not campaigning directly for Barber as they did two years ago. This time, they're campaigning through their super PAC, Americans for Responsible Solutions.

The PAC was set up to promote stronger gun laws, and it's been running some tough, emotional TV ads attacking Barber's opponent, Republican Martha McSally.

This one features a Tucson woman named Vicki.

Americans for Responsible Solutions/YouTube

"My daughter was just 19 when she told her boyfriend their relationship was over, and he got a gun and he shot her and my husband," Vicki says in the ad.

An announcer says, "Martha McSally opposes making it harder for stalkers to get a gun."

Vicki continues, "I don't think she really understands how important that is for a lot of women."

The ad got a swift, harsh response from McSally.

"I was disgusted by that ad," she said.

Not terribly surprising that a candidate would be offended by an ad suggesting she was somehow responsible for a double murder. But McSally startled people by saying the ad bothered her for another reason: McSally said she had been the victim of a stalker.

i i

Republican Martha McSally is running for the Arizona House seat once held by Gabby Giffords. Cliff Owen/AP hide caption

itoggle caption Cliff Owen/AP

Republican Martha McSally is running for the Arizona House seat once held by Gabby Giffords.

Cliff Owen/AP

"So it is personally offensive to me, because I know what it's like to live in fear," she said. "In addition, I put the uniform on every day and put my life on the line."

McSally, the first female Air Force fighter pilot to fly in combat, says she was stalked and held hostage while on assignment. She wouldn't give details.

In an editorial, the Arizona Republic condemned the ad as "base and vile." But Pia Carusone, executive director of Americans for Responsible Solutions, stands behind it.

"It's an intense issue," Carusone said. "People die every day in this country from gun violence."

At issue is a federal rule allowing stalkers convicted of misdemeanors to own a gun. Stalkers convicted of felonies cannot legally own guns.

Giffords' group calls that the stalker gap, and wants the gap closed. The PAC also wants background checks for private sales at places like gun shows.

McSally is on record as being opposed to any new laws restricting gun ownership. So, while the ad may have been over the top, technically it was correct.

Barber was mum about the ad, but said he supports Giffords on the issue.

"I believe that the only way to stop stalkers, who might have a gun and might hurt somebody because of that, is to expand the background check system so that 40 percent of the gun sales in this country cannot be made outside of the background check system," he said.

McSally doesn't support expanding background checks, but she has changed her mind on stalkers. She now says she agrees those convicted of misdemeanors should be barred from owning guns.

Carusone counts that as a victory for Giffords' PAC, and cites it as a reason the group has stopped airing the ad. But she says the Arizona race is just one of 11 House and Senate races it's pumping money into, all of them important.

The Two-Way

Book News: Gabrielle Giffords Writing Book About Gun Control

"From a business perspective, we don't want to lose, right?" Carusone said. "We're in the business of winning, right? We're in the business of changing minds."

Yet the website Open Secrets says Americans for Responsible Solutions has so far spent nearly $1 million to keep Giffords old seat from turning Republican — almost double the amount it's spent on any other race.

Two years ago, the gun violence against Giffords and Barber was fresh and personal for her southern Arizona district. Sympathy almost certainly played a part in deciding the race.

It's not yet clear how much Giffords' support means this year.