FDA Proposes First Regulations for E-Cigarettes

The FDA is proposing regulations that would rein in the e-cigarette industry (Getty Images).

The FDA is proposing regulations that would rein in the -cigarette industry (Getty Images).

by Rob Stein (NPR) and Rachel Dornhelm

The Food and Drug Administration Thursday proposed regulating e-cigarettes for the first time.

The agency unveiled a long-awaited rule that would give it power to oversee the increasingly popular devices, much in the way that it regulates traditional cigarettes.

“It’s a huge change,” FDA Commissioner Margaret Hamburg told reporters in a briefing before the official announcement of the agency’s plans. “We will have the authority as a science-based regulatory agency to take critical actions to promote and protect the health of the public.”

The proposal will be subject to public comment and further review by the agency before becoming final. But once that happens the rule would impose new restrictions, including:

  • A ban on the sale of e-cigarettes to minors
  • A prohibition on distributing free samples
  • A ban on selling e-cigarettes in vending machines unless they are in places that never admit young people
  • A requirement that e-cigarettes carry warnings that they contain nicotine, which is addictive
  • E-cigarette manufacturers would be required to disclose the ingredients in their products
“This announcement starts the process that will give us the authority to actually get out there and regulate e-cigarettes.”

Rep. Jackie Speier (D-San Mateo), who has asked for congressional hearings on the topic, called the regulations today “long overdue.” In a statement today, she said she wants to see wider governmental control of the $2 billion industry, especially provisions that govern advertising to minors and former smokers.

“Although the proposed rule does make long awaited changes such as restricting the sale of e-cigarettes to minors, there are important pieces missing — such as child-proof packaging. Too many children have ended up poisoned by the devices,” Speier said.

California Sen. Barbara Boxer also immediately responded to the FDA’s move and called for further action.

“Now it is time for the Administration to take the next important step by banning the outrageous marketing of e-cigarettes to our kids, including the use of candy flavors and cartoon advertisements that are shamelessly designed to lure and addict them,” Boxer wrote in an email statement.

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Waiting For Medi-Cal To Kick In

Teresa Martinez, 62, works as a hairdresser at a Koreatown hair salon. She earns about $10,000 per year and cannot afford to buy private health coverage (Photo by Heidi de Marco/KHN).

Teresa Martinez, 62, works as a hairdresser at a Koreatown hair salon. She earns about $10,000 per year and cannot afford to buy private health coverage (Photo by Heidi de Marco/KHN).

by Anna Gorman, KHN

For most of Teresa Martinez’s life, buying health insurance has been out of the question. She works at a Koreatown hair salon, earning about $10 per cut – not nearly enough to afford private coverage.

With a long list of ailments including dizziness, blurry vision and leg pain, she eagerly applied last year for a county program that would cover her for free until Obamacare set in.

“I thought at long last, I would be able to go to the doctor and get what I need,” said Martinez, 62, who lives in East Los Angeles. “I was so excited. But that was short lived.”

The state has 45 days to process the Medi-Cal applications but it often takes longer and the waiting period varies — sometimes widely — by county.

Without any explanation, Martinez received a denial letter from the Healthy Way Los Angeles, a temporary coverage program for low-income people. Later she applied for Medicaid — known as Medi-Cal in California — which was expanded under the Affordable Care Act to include people like Martinez without dependent children.

But a health clinic worker told her she may have to wait months for approval — and to hold off on appointments until she has her official card.

Nearly 2 million Californians have gained coverage with the expansion of the Medi-Cal program for poor and disabled people, including those who transitioned from temporary programs like Healthy Way LA. Continue reading

Expert: Millions More Uninsured Will Get Coverage in Next Three Years

Covered California application in Chinese.

Covered California application in Chinese.

By Rachel Dornhelm

Now that the final numbers from Covered California’s first open enrollment period are in, experts are already looking ahead to the next steps.

Nearly 1.4 million Californians have signed up for health care coverage through the exchange. Another 1.9 million are now covered by the expanded Medi-Cal program. That’s almost 3.5 million state residents.

And yet 5.8 million Californians remain uninsured.

Gerald Kominski, professor of Health Policy and Management and director of the UCLA Center for Health Policy Research, said these numbers are on target with early projections.

Kominski says about one million of the remaining uninsured are undocumented and not eligible for coverage under the Affordable Care Act. But he expects the majority of the others will gain insurance over the next few years.

“We really think that enrollment in ACA is a 3-year process rather than get everyone enrolled the first year,” Kominski said.

He projects that by 2017 the number of remaining uninsured, excluding those who are undocumented, will be 1.2 million people.

“I think that would be a tremendous success,” Kominski said.

So why the lag time?

“We projected there would be full expected enrollment after three years of the program,” Kominski said. “Part of that is because of the tax penalties that get phased in over the next three years. No one has paid a penalty yet for being uninsured. That will happen next April when income taxes are due.”

Once the penalties hit home, Kominski said he expects those additional enrollments will start rolling in.

The other big issue that health policy experts are keeping their eyes on going forward is so-called churn.

Ken Jacobs, chair of the UC Berkeley Labor Center, said that it’s important that the huge outreach effort continues — both because of Californians that remain uninsured and those that may lose their insurance in coming years for any number of reasons.

Changing jobs, getting married or divorced, having or adopting a baby — any of these are qualifying events that will allow people to sign up for coverage outside of the open enrollment periods.

Jacobs said at least half a million Californians will become newly eligible for the exchange during the course of the year by losing their existing coverage.

The information storm around the initial enrollment period may be over. But experts say while millions of Californians signed up during this first phase, there are still millions more who will be shopping for Covered California plans over the next few years.

California Legislature To Consider Antibiotic Ban in Animals

Stanford University Infectious Disease Specialist David Relman with Assemblyman Kevin Mullin looking on (Jeff Walters/Assembly Democratic Caucus).

Stanford University Infectious Disease Specialist David Relman with Assemblyman Kevin Mullin looking on (Jeff Walters/Assembly Democratic Caucus).

By Joe Rubin

A new bill in the California Legislature could give California the distinction of going where the federal government hasn’t — more strictly regulating the way that livestock are given antibiotics.

But freshman state Assemblyman Kevin Mullin (D-South San Francisco), who is introducing state Assembly Bill 1437, says getting it through the agricultural committee is a bit of long shot.

More than 70 percent of all antibiotics in the U.S. are given to animals, often to healthy livestock. Until very recently drug companies marketed the growth-promoting benefits of antibiotics. And many meat producers, keen for additional profits and assured by pharmaceutical companies that the practice was safe for people and animals, would routinely add antibiotics to feed.

In December, the Food and Drug Administration, after years of debate on the issue, asked drug companies to voluntarily stop marketing the growth-promoting benefits of antibiotics out of concerns for public health. The companies are largely complying. But critics like the Natural Resources Defense Council and New York Times food writer Mark Bittman have criticized the FDA’s approach as lax and unlikely to lead to any real change.

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Walgreens Store Redesign Raises Privacy Concerns

(Lisa Aliferis/KQED)

(Lisa Aliferis/KQED)

By Chris Richard

Privacy activists are voicing concern that Walgreens pharmacies may endanger the confidentiality of customer records with a new business model that places pharmacists at a desk on the store floor.

The “Well Experience” model makes it much easier for customers to view pharmacists’ computer screens and documents on their desks, according to a report prepared by the research arm of Change to Win, a labor-backed organization whose constituents include pharmacists and pharmacy technician unions.

“We have heard from pharmacists, not necessarily in our membership, who work in this model, who are very concerned about its implications for the practice of pharmacy,” said Nell Geiser, associate director of Change to Win Retail Initiatives.

“Think about it for a moment. If you were to go to a doctor, would you want to be out in the lobby talking to your doctor?” — Beth Givens, director of the San Diego-based Privacy Rights Clearinghouse

“Pharmacists want to do their job well and serve the public, and they also want to protect their license, which is on the line if any error takes place in their pharmacy.”

Change to Win is concerned about the possibility of increased thefts — especially of narcotics –   as well as the risk of errors in formulating prescriptions under the new Walgreens model. The model removes pharmacists from their usual in-person supervisory role, Geiser said. Continue reading

Powerful Narcotic Painkiller Up For FDA Approval

(Getty Images)

(Getty Images)

by Rob Stein, NPR

The Food and Drug Administration is trying to decide whether to approve a powerful new prescription painkiller that’s designed to relieve severe pain quickly, and with fewer side effects than other opioids.

While some pain experts say the medicine could provide a valuable alternative for some patients in intense pain, the drug (called Moxduo) is also prompting concern that it could exacerbate the epidemic of abuse of prescription painkillers and overdoses.

An FDA advisory committee is holding a daylong hearing Tuesday to decide whether to recommend that the agency approve the drug.

“This is a product that is very easy to misuse, very easy to crush and snort or crush and inject,” says addiction specialist Andrew Kolodny.

Moxduo for the first time combines morphine and oxycodone in one capsule. It’s designed to provide quick relief to patients suffering severe pain from accidents or surgeries, such as knee replacements, back surgeries or cancer operations, says Ed Rudnic, COO of QRxPharma, the company that makes Moxduo.

The drug allows patients to take lower doses of the two narcotics than they’d need if they took either of the medicines alone, Rudnic says.

“We believe that we’ve achieved some benefit in reducing the risk of some of the respiratory complications of these strong opioids,” he says.

Suppressed breathing and other respiratory complications are the most serious risks of these drugs — the main reason people die from taking too much.

Some pain experts think the idea behind Moxduo is a good one. A lot of patients can’t take enough morphine or oxycodone to ease their discomfort because of the risk to breathing and other side effects, such as nausea, vomiting, dizziness and severe itchiness.

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Obamacare Opens Door for Some to Leave Jobs

Because Mike Smith of Long Beach was able to get insurance through the Affordable Care Act, he could retire from his job. (Stephanie O'Neill/KPCC)

Because Mike Smith of Long Beach was able to get insurance through the Affordable Care Act, he could retire from his job. (Stephanie O’Neill/KPCC)

By Stephanie O’Neill, KPCC

It’s just after noon on a recent weekday and Mike Smith, 64, of Long Beach is standing over his stove, gently mixing together a sizzling dish of bright green brussels sprouts with caramelized shallots.” Even people who don’t like brussels sprouts love this dish,” he says of the recipe he culled from the pages of Bon Appétit Magazine many years ago.

They were afraid if they tried to buy insurance on their own, an insurance company would reject them. And now that can’t happen.”
We’ve got organic shallots, organic brussels sprouts and organic apple cider vinegar,” Smith says as he stirs the ingredients. “I love the smell of the shallots, don’t you?”

Until recently, Smith had little time to to experiment in the kitchen, to practice guitar or to visit his elderly in-laws or his two-year-old grandchild.

Instead, he worked 11 hours a day, Monday through Friday and then half a day on Saturday, as a district manager for a national auto parts chain. Early retirement, while certainly appealing, wasn’t a viable option, as both he and his wife relied heavily on his job-provided health insurance. Continue reading

In Los Angeles, How Pharmacists Are Improving Patients’ Health

Dr. Sarah Ma goes over medications and dosages with diabetes patient Joe Navarro. (Credit: Anacleto Rapping)

Sarah Ma, a pharmacist with USC, goes over medications with diabetes patient Joe Navarro. (Credit: Anacleto Rapping)

By Laurie Udesky, CHCF Center for Health Reporting

Jose Navarro regularly trekked to the drugstore after being diagnosed as a diabetic seven years ago. In a sign of transformation in the local fight against diabetes, the pharmacist is now coming to him.

On a recent day Sarah Ma, a 28-year-old USC clinical pharmacist, set up shop at Navarro’s kitchen table in Santa Ana.

She checked Navarro’s blood pressure and blood sugar, examined his feet for cuts or infection, and refilled his monthly pill box. On previous visits she had changed the hour he took some medications, altered some doses, and discontinued others.

She inspected the refrigerator. “I see carrots, eggs, beets, cheese and yogurt that I haven’t seen before,” she said, delighted.

It wasn’t all great news. Navarro, 78, had told Ma that the pastry he had at breakfast was tiny. Actually, it engulfed half the plate Ma brought with her to illustrate what portions to eat of different food groups. Continue reading

Caffeine: How Our Favorite Drug Affects Us

(Getty Images)

(Getty Images)

As I’m writing this, I’m hitting my mid-afternoon slump. And it’s Friday, no less. The time seems perfect for a cup of coffee. And now, because caffeine was the topic on KQED’s Forum this morning, I know how and why caffeine is an apparent energy booster.

And who knew it was also a natural pesticide?

“Its primary role is a simple one,” said Forum guest Murray Carpenter. He’s the author of Caffeinated and is full of facts about the “bitter white powder.” Let’s start with the biochemistry: caffeine blocks a neurotransmitter called adenosine. This is the signal that tells you that you are drowsy. When you consume caffeine, it blocks adenosine from sending the “fatigue” message. “Fully 50 percent of the receptors are blocked” after we consume caffeine, Carpenter explained, “and it’s that simple trick that allows caffeine to do its work.”

But caffeine has another role that I had never heard of: it’s a natural pesticide. If insects consume a caffeinated plant, they become paralyzed and die. Odd that it works so differently on humans.

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Male in Life, Female in Death: The Story of Christopher Lee’s Death Certificate

Christopher Lee lived his life as a man, but after he died by suicide, the death certificate listed his gender as female.

Christopher Lee lived his life as a man, but after he died by suicide, the death certificate listed his gender as female.

By Matt Levin

Death certificates are typically pretty boring documents. A box for name, a box for date, a box for place and time, for cause of death. A bureaucratic afterthought to help family and friends settle the affairs of a deceased loved one.

“I looked at it, and it said ‘female’ on it. And I asked her, ‘Why does it say female? He was male.’”
A death certificate was not on the forefront of Chino Scott-Chung’s mind as he waited for the ashes of his best friend, Christopher Lee. Lee, 48, had committed suicide in December 2012, and Scott-Chung was still reeling from the death of the friend who had served as best man in his wedding.

After receiving the ashes, Scott-Chung prepared to leave when the employee from the Oakland cremation services company handed him Lee’s death certificate.

Scott-Chung immediately noticed something was wrong. Something that Christopher would never have consented to if he were still alive. Continue reading