When Lanarion Norwood Jr. was 9 years old, he opened his family’s refrigerator to find it almost empty. His grandmother, unemployed because of disability, had run out of food for the month. So Norwood did what many young children adamantly resist: He went to bed early. Sleeping, he reasoned, would help him suppress hunger, and he knew the next day he could eat at his Atlanta school.

That memory is one of Norwood’s earliest recollections of being hungry, but not his last. As a teenager, his food concerns grew with his appetite. “I would plan out my meal[s],” Norwood says, now a freshman at Morehouse College in Atlanta. “I knew I could eat breakfast and lunch at school and I could eat again later at [an afterschool mentoring program].”

Lots of kids like Norwood rely on schools for food their families can’t afford. Federal programs like the National School Lunch Program offer free or discounted meals to children from low-income families. But two reports out this month from the Urban Institute and Feeding America suggest one group is falling through the cracks: teenagers. Roughly 7 million children in the U.S. aged 10-17 struggle with hunger, according to one report, which examines teenage access to food. Dogged by hunger, teenagers may try a wide range of solutions, from asking friends for meals to bartering sex for food.

To learn about teen hunger, the researchers partnered with food banks and, with funding from Conagra, conducted 20 focus groups across the country with adolescents from low-income families. The researchers found two challenges to feeding teens in need: First, some of the charitable programs that target young children — like backpack programs that allow kids to take food home over the weekend — aren’t always offered to teenagers. And second, even when programs are available, teenagers feel more self-conscious about accepting free food or may not realize that they are eligible for the assistance.

Lead researcher Susan Popkin of the Urban Institute explains why the challenges facing teenagers are unique: “It’s easier to get to little kids. They’re all in school. They’re certainly more cooperative. Teens are often seen as the problem. Not as part of the solution.”

Teens, Popkin explains, are more aware of the stigma associated with a free lunch than younger children. They’re also at an age where fitting in is paramount. So many teens will forego official programs and try to get meals from other places – by going to a friend’s house with a well-stocked pantry, for example.

Norwood says pride is a major hurdle. “Why should I have to go through a program just to eat when I’m almost grown?” he says, describing the attitude of some of his peers.

Even adolescents who do opt to take advantage of school programs may not get a good meal, according to Popkin, because they often receive the same portion sizes as elementary school children. What’s more, teens often squirrel the meal away for younger siblings.

“They feel the pressure that their parents are under,” she says. “They’re old enough to be aware of it and they want to help. They go hungry along with their parents.”

Teenagers cope with hunger in other ways too, the researchers found. Teenagers try to get jobs, but often struggle against the competition of adults with more experience and more flexible hours. The jobs they can get — like cutting hair or mowing grass — often don’t pay well enough to bridge the gap in the family’s food budget.

Sometimes teenagers turn to less benign methods to get money or food. Teenagers in the focus groups cited petty theft and even gang membership as methods adolescents used to put money and food on the table.

Most surprising to Popkin was that some teenagers, girls in particular, date older men with more disposable money in order to get food. Thirteen of the 20 focus groups talked about trading sex for a meal.

What can be done to improve the plight of food-insecure teenagers? Popkin says simply extending elementary meal programs to teenagers could be a start, as well as increasing portions with age.

Emily Engelhard, managing director of research and evaluation for Feeding America, says teens came up with other ideas as well, like tying free food to another less stigmatized activity – like movie night or a basketball game. She says an important takeaway from the research is “just how incredible and resilient these teens are.”

Better and more accessible grocery stores in low-income neighborhoods would also help, says Norwood. He says many people in Atlanta have to take a bus or train to reach a grocery store with fresh produce and can’t afford the time or fare, to say nothing of lugging the groceries home.

He sums up the importance of teen hunger simply: “It is real. It is serious. And it should be addressed. It affects the mind, it affects the body, and it affects the soul. Without that, what do you have?”

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Donald Trump sat down with controversial TV host Dr. Mehmet Oz on his show, set to air Thursday, to discuss his personal health and medical history.

The Republican presidential nominee’s campaign had said earlier Wednesday he wouldn’t be releasing on The Dr. Oz Show the results of a physical the 70-year-old candidate underwent last week. But a press release from the show said the two did discuss the recent physical along with his personal health, his views on health care policy and his recent proposal for child care and maternity leave:

“Mr. Trump shared with Dr. Oz the results of his physical examination performed last week by Dr. Harold Bornstein, M.D. of Lenox Hill Hospital, whom has been Mr. Trump’s personal physician for many years,” the statement read, also noting that Dr. Oz “took Mr. Trump through a full review of systems” including his nervous system, bladder and prostate health, cardiovascular health, gastrointestinal health, family medical history and more.

Bornstein released a letter last December declaring that Trump would “be the healthiest individual ever elected to the presidency” and called his health “astonishingly excellent.” NBC News reported last month that Bornstein had written the letter in five minutes while a limo sent by Trump waited outside his office.

Wednesday’s taping was closed to the press, but NBC’s Katy Tur reported that a source inside the studio said Dr. Oz read the full report of his physical and “said he was very healthy and that he would be happy if any of his patients had similar results.” His blood pressure was reportedly good as was his cholesterol, though he is on cholesterol medication. He weighs 267 pounds (though other reports have said the number was 230 pounds) and Dr. Oz said Trump was “slightly overweight.” Trump also said “never has a need to go to a hospital because he’s too healthy.”

According to a CNN interview with an audience member, Trump also said he wants to lose about 15 pounds.

Trump also reportedly had some surprising comments about his exercise regimen and eating habits, per NBC’s Jesse Rodriguez.

Both candidates have been under pressure to release more of their medical history. Democratic nominee Hillary Clinton, 68, is set to return to the campaign trail on Thursday after falling ill with pneumonia.

The choice to reveal medical results on a TV talk show is an unusual one for a presidential candidate, but one that is certainly in line with the former reality TV star’s unconventional campaign. Oz, a cardiothoracic surgeon by training, developed a loyal following after appearing on The Oprah Winfrey Show through the years. But the celebrity doctor has also come under scrutiny for hawking products that have no scientific validity, particularly weight-loss supplements. Oz also said on Tuesday he wasn’t going to ask Trump “questions he doesn’t want to have answered.”

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Three years ago, Geoff Baird bought a drone. The Seattle dad and hobby plane enthusiast used the 2.5-pound quadcopter to photograph the Hawaiian coastline and film his son’s soccer and baseball games.

But his big hope is that drones will soon fly tubes of blood and other specimens to Harborview Medical Center, where he works as a clinical pathologist running the hospital’s chemistry and toxicology labs. In the near future, Baird and others say, drones could transform health care — not only in rural areas by bringing critical supplies into hard-to-reach places, but also in crowded cities where hospitals pay hefty fees to get medical samples across town during rush hour. By providing a faster, cheaper way to move test specimens, drones could speed diagnoses and save lives. “It’s superexciting to me,” Baird says.

The technology seems to be there. Drones are delivering pizza in New Zealand and taking condoms to parts of Ghana that lack reliable roads or access to birth control. Tech giants and big retailers, including Amazon and Wal-Mart, are testing drones for deliveries and pickups.

However, “blood specimens are not like a book or a shoe,” Timothy Amukele, an assistant professor of pathology at Johns Hopkins School of Medicine, said in a TED talk earlier this year. No one knew whether bumpy flights would hurt cells or otherwise make biological samples unsuitable for lab tests.

So Amukele and co-workers conducted several experiments to find out. In their first study, published in PLOS ONE last July, the team collected several hundred blood samples from healthy volunteers. They drove the samples to a flight field an hour northwest of Baltimore, packed half of them into foam containers and flew them around in a drone for up to 40 minutes. The other samples sat. All specimens went back to the lab for 33 routine tests. The results were the same for each group, suggesting samples stay intact during drone flights.

In follow-up analyses, drone transport also seemed safe for samples containing microbes and for donated blood. The microbial study was published in August in the Journal of Clinical Microbiology; a manuscript on the blood products study is under review. (Videos of each experiment can be found here.)

“The results don’t surprise me,” says Bill Remillard, chief technical officer at TriCore Reference Laboratories in Albuquerque, N.M. “But until you do the science, you just don’t know.”

TriCore handles nearly three-quarters of New Mexico’s clinical lab testing. And in a sparsely populated state, moving samples over large distances is expensive. TriCore spends $3.5 million per year. So after Remillard heard the results of Amukele’s first drone experiment at a meeting last summer, the two started discussing a possible pilot study using drones to transport lab samples in New Mexico.

While Amukele’s experiments show it’s feasible to move lab specimens with drones, pilot studies in real clinical settings are still needed to work out logistics. Questions include how to request a drone, where it would land, who would pick up the samples and how often a drone would need new batteries.

Safety is another concern. Some drones drop cargo with parachutes or other release mechanisms, making it harder for people to tamper with the vehicles. But as far as how safe drones are, “those data don’t yet exist,” Amukele says. Though millions of drones have been sold worldwide, “we don’t know how many crashes happen and how many are due to operator error,” he says. The Federal Aviation Administration is starting to collect this data.

It’s a promising development for an industry where legislation has lagged behind the fast-advancing technology. For years, the FAA had imposed a near-ban on commercial drones, only allowing them to fly if businesses applied for an exemption. But in June the agency announced a set of rules for companies to operate drones in the United States, and on Aug. 29 those regulations took effect. The FAA expects the number of registered commercial drones to jump 30-fold, from 20,000 to 600,000, within months.

“The rules had not been well defined. This is an attempt to define them,” says Lawrence Williams, who heads business development at Zipline, a Silicon Valley startup making drones for medical applications. Zipline is focusing much of its effort in Rwanda, where less crowded skies, relative to the U.S., make it easier to negotiate drone delivery of blood samples.

Another drone startup, Vayu, whose CEO is a co-author on the PLOS ONE drone study, is also dipping into the international arena. In July, the Michigan-based company did a demo flight in Madagascar, carrying specimens from a remote village to a lab for testing. Vayu makes a quadricopter plane capable of vertical takeoff — an appealing feature for hospitals with limited landing space.

While it’s easy to see how drones could improve health care in poor countries, Amukele thinks medical drone delivery could make a bigger splash in the U.S. Compared to Africa and developing countries, the U.S. does much more testing per person, he says, and many of the country’s 200,000 medical labs are collection-only sites that rely on central labs for testing. So “there are likely to be more [medical drone users] in the U.S. than anywhere else,” Amukele says.

As Zipline prepares to launch blood delivery drones in Rwanda, the company is also seeking regulatory approval for three projects using drones to bring medical supplies to underserved communities in the U.S.

One project would integrate drone delivery of medications with telemedicine appointments at a small clinic in rural Maryland. Another would use Zipline drones to link a large health care distribution center to hospitals and tribal clinics around Reno, Nev. And for the third project, the company would partner with a regional blood bank in Washington state, creating a plan to distribute blood to various hospitals and clinics in the event of earthquakes and other natural disasters.

Johns Hopkins was initially skeptical of Amukele’s experiments — the review board thought his first proposal was a joke — but now the university is giving the pathologist space and funds to hire a drone engineer and continue researching medical delivery drones.

In Seattle, Baird is working with Amukele and aeronautical engineers at the University of Washington on their own drone proposal. Ideally their test flights would take samples from Seattle Children’s to Harborview, a bustling facility that runs thousands of tests each day. However, that flight path would violate the FAA rule requiring drones to stay within the pilot’s line of sight. So the initial plan is to run 2-mile line-of-sight flights between the children’s hospital and UW Medical Center, Baird says.

Drones could be a huge help in poison emergencies, Baird says. In a typical scenario, a child gets rushed to the emergency room after accidentally swallowing some pills. Though routine tests can rule out some things, clinics often send samples to a centralized toxicology lab for confirmation and further testing. This can take hours. A drone could zip samples downtown in five to 10 minutes, Baird says, helping a child get diagnosed and receive medications more quickly.

He also envisions drones collecting samples from patients’ homes and taking them to the hospital. You could prick your finger and rub the blood onto a card that a drone could fly back to the lab for testing, Baird says.

In the meantime, though, Zipline’s U.S. projects remain on hold, awaiting the regulatory go-ahead, and the Seattle team continues studying maps and sketching flight routes for the small drone test it hopes to launch. The team has presented the plan to grant agencies and gotten positive responses — but no funding yet.

Like other technological advances, Baird suspects drones for medicine will “wait, wait, wait and then go very quickly.”

Esther Landhuis is a freelance science journalist in the San Francisco Bay Area. Follow her at @elandhuis.

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The nation’s opioid problem comes with staggering physical and emotional costs to patients and families. But the financial burden on the health system has been harder to peg.

A report set to be released Tuesday shows a more than thirteenfold increase in spending by health insurers in a four-year period on patients with a diagnosis of opioid dependence or abuse.

From 2011 to 2015, insurers’ payments to hospitals, laboratories, treatment centers and other medical providers for these patients grew from $32 million to $446 million.

While the latest figure represents a small portion of the overall spending on medical care in the United States, the rapid rise is cause for concern, says Robin Gelburd, president of Fair Health, a nonprofit databank that provides cost information to the health industry and consumers.

“That really shows the stress on the health system and the impact on the individuals,” said Gelburd.

The Fair Health study found a sharp difference in how much insurers spend on individual patients with such a diagnosis.

On average, insurers spend $3,435 a year on an individual patient, but for those with an opioid dependence or abuse diagnosis, that amount jumps to $19,333. Those numbers reflect what insurers actually paid. The report also includes data on what providers charged, amounts that are lowered by their contracts with insurers.

The study, out Monday, builds on a study Fair Health released in early August that found a thirtyfold increase in the volume of insurance claims related to opioid dependence diagnoses between 2007 and 2014.

The latest study by Fair Health — part of a series — looked at amounts associated with claims billed by providers and paid by insurers for the types of medical services used.

Both studies use de-identified claims data from insurers representing more than 150 million insured Americans who either have insurance through work or buy coverage on their own.

There have been other efforts by several researchers to quantify the cost of the opioid problem on the overall economy, estimated in the tens of billions of dollars.

The new report adds to the available data “that it’s not just the human cost associated with the opioid crisis that is enormous, but also that the economic costs are staggering,” said Dr. Andrew Kolodny, senior scientist at Brandeis University. He didn’t work on the study.

The surge in spending on patients with opioid diagnoses is likely a combination of factors, the report notes. As media attention focuses on drug dependency, more people may be seeking treatment. At the same time, prescription and illegal use of narcotics may also be increasing.

The study found that emergency room visits and laboratory tests accounted for much of the spending.

Based on claims volume, the fastest-growing set of services in terms of utilization were for alcohol or drug therapy. Lab tests, including checks for barbiturate or opioid use, weren’t far behind.

Researchers didn’t use 2015 data for lab test costs, noting that a change in billing codes was made that increased the number of categories — and, in some cases, appear to generate higher charges by insurers. It is too early to estimate the long-term effects of the change, Gelburd said.

The report gives some examples of the changes, however. For example, one billing code for a test on opiate use commonly brought in a $31 payment from insurers prior to the change. The two billing codes that replaced it now are commonly paid at $78 and $156.

The new billing codes may reflect new technology in testing, said Gelburd. She said some observers speculate that the rapid increase in lab spending might reflect that, with more patients in therapy, the tests are being used to ensure they are taking their proper medications and not abusing narcotics.

But the spending might also reflect a growing use of very expensive urine and blood tests when less expensive ones would be sufficient, said Kolodny.

“I worry about profiteering,” said Kolodny. “We do need tests, but not the expensive ones. A lot of clinics are making extra money off these lab tests.”

The overall increase in spending across all types of medical services “is a societal issue,” said Gelburd, who says policymakers need to ensure that changes are made to address the problem.

“Are medical school curricula adjusting to recognize the growing need for these services? Are insurers increasing the number of providers in their networks to ensure sufficient access? Are consumers being educated? It’s an issue that has to be dealt with in all quadrants.”

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Julie Appleby is on Twitter: @Julie_appleby.

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When it comes to navigating the intricacies of health insurance, Cassie Ray considers herself a pro. She actually reads her policy, including the fine print.

So when the 57-year-old from Fairfield, Calif., needed routine follow-up surgery after a mastectomy, she did her homework. “I looked up on my insurer’s network and made sure the outpatient facility that I was being referred to was in my network,” Ray says.

A month later, she received an unwelcome surprise: a $580 bill for an out-of-network anesthesiologist.

“I called the facility back, and at first, I felt like, this has to be a mistake. They’ll fix it,” Ray says.

Instead, the clinic said her only option was to negotiate the bill directly with the doctor. Ray’s experience illustrates the surprise of balance billing.

The unexpected charged come when patients are treated by an out-of-network provider at an in-network facility.

After several failed attempts in recent years, the California legislature last week passed AB-72, which aims to protect patients’ pocketbooks when they’re hit by these surprise bills. Gov. Jerry Brown has until the end of September to sign or veto the legislation. He is expected to sign it into law.

A 2015 Consumers Union survey suggests the surprise bill phenomenon is fairly common. It found nearly 1 in 4 Californians who’d had hospital visits or surgery in the prior two years reported receiving an unexpected bill from an out-of-network provider.

“They can range in price from a hundred dollars to many thousands,” says Betsy Imholz, special projects director for Consumers Union. “So it’s a big financial burden on consumers.”

In Ray’s case, she says she tried to speak with a manager at the outpatient clinic, but no one returned her repeated calls. Then the bills stopped coming, so she figured all was resolved. Soon after, however, her bill was sent to collections.

“I was so frustrated,” she recalls. “I was just in tears as I was dealing with it.”

Ray says it took about seven months of wrangling before her insurance company finally paid the bill and she was able to clean up her credit rating.

“My immediate response was, there does need to be a law to fix this,” says Ray. “This is so wrong.”

The legislation, by Assemblyman Rob Bonta (D-Oakland) and six colleagues, would limit a patient’s financial obligation to no more than what he would have owed if the provider had been in-network.

While agreeing that “patients should never have surprise bills,” Dr. Karen Sibert, president-elect of the California Society of Anesthesiologists, says her organization and a number of other specialty medical groups oppose AB-72.

At issue, Sibert says, is the bill’s formula for paying doctors who fill the gap left when insurance companies don’t have enough providers in their networks. The legislation would set the payment rate at either the amount the insurer normally pays a doctor on contract for such services or 125 percent of the Medicare rate, whichever is greater.

That’s insufficient, argues Sibert. “It’s a problem because it removes any incentive for insurance companies to reach fair contracts with physicians.”

Without such an incentive, she says, insurance companies will continue to stick consumers with inadequate provider networks.

The powerful California Medical Association agrees with Sibert about the bill’s payment formula, but it has shifted its position on AB-72 from opposed to neutral, says Janus Norman, the Association’s vice president of governmental affairs.

There are a few reasons for the change of heart, he says. First, the bill would create stricter oversight of how in-patient services are delivered, and it would allow for tougher regulations on insurers if the state finds their provider networks to be inadequate.

The provision regarding tougher regulations, “is one improvement that AB-72 included that prior legislation did not,” he says.

In addition, the measure would give out-of-network doctors the chance to appeal payment disputes with insurers through an independent third party, and the decision would be binding, another important change from previous versions of the bill, Norman says.

The California Association of Health Plans and the Association of California Life and Health Insurance Companies don’t have a formal position on AB-72, according to an analysis by the Assembly Health Committee. Instead, they have expressed “concerns” about the measure, the committee said.

“While they laud the authors’ efforts to protect consumers from balance billing,” the analysis says, the insurer groups worry that the legislation might lead to higher premiums and cost-sharing, and that the bill’s dispute resolution process might spark more lawsuits between providers and health insurance firms.

Anthony Wright, executive director of Health Access California, a consumer health care advocacy coalition, says Gov. Brown took an interest in the legislation.

“The governor’s office did provide input during the negotiation process and we are hopeful that he will sign it,” he says.

Consumers Union’s Imholz says the California Medical Association’s neutral position on the legislation was key in getting AB-72 across the finish line.

She predicts that if Brown signs the measure, a number of other states now considering similar protections against surprise bills will likely follow suit next year.

This story is part of a reporting partnership with NPR, KPCC and Kaiser Health News.

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Almost half of all Americans take prescription painkillers, tranquilizers, stimulants or sedatives, according to results of a federal survey released Thursday. The prevalent use of these drugs could help explain why millions of Americans end up misusing or abusing them.

Last year, for the first time, the government’s National Survey on Drug Use decided to ask the people it interviewed about all uses of prescription medicines, not just inappropriate use. The survey found that 119 million Americans age 12 and over took prescription psychotherapeutic drugs. That’s 45 percent of the population.

Of those, about 19 million Americans didn’t follow a prescription. Most misuse involved people who acquired the drugs from friends or family. More than a third had a prescription but took those drugs excessively. And about 5 percent bought drugs from a dealer or stranger.

All told, 16 percent of all prescription drug use was actually misuse, according to the report.

There’s no question that these drugs help alleviate pain and suffering for millions of Americans. But it’s also clear that the system encourages overuse.

“Any of us go to the doctor and feel like we don’t get our money’s worth if we don’t come out with a prescription, right?” Kim Johnson told Shots. She is director of the Center for Substance Abuse Treatment at the federal Substance Abuse and Mental Health Services Administration.

“Just like any drug, the more it’s out there, the more it’s available, the more likely it is to be abused,” she said. And many of these drugs pose an additional risk because of their physical effects, including in some cases their addictive properties.

The Centers for Disease Control and Prevention is trying to reform prescribing practices, particularly for opioid drugs, to reduce the overuse of these pain medications. The new survey also documents the dire need for affordable and accessible treatment options.

“One in 12 people aged 12 or over needed treatment for substance use disorder, yet nearly 90 percent of those people didn’t get specialty treatment that could have helped them toward recovery,” said Kana Enomoto, SAMHSA’s principal deputy administrator, at a news conference.

That need for treatment pertains not just to prescription drug abuse but to street drugs such as heroin.

“We need to expand access to treatment and we need to do it now,” said Michael Botticelli, director of the White House Office of National Drug Control Policy. “Because, like every other disease, people who want treatment should be able to get it. And it should not be dependent on where they live or how much money they have.”

President Obama’s budget for fiscal year 2017 called for more than $1 billion to expand access to drug treatment, but Congress has not acted on it.

You can email correspondent Richard Harris.

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Rising concerns about spending on prescription drugs that treat rare diseases are overblown, according to an analysis published Wednesday in the journal Health Affairs.

“We wanted to focus on the true impact of orphan drugs,” said Victoria Divino, a senior consultant at IMS Health and an author of the study. Researchers at IMS Health, a health care analytics firm, and drugmaker Celgene Corp. looked at U.S. pharmaceutical spending from 2007 to 2013 on more than 300 drugs that had orphan approval under the 1983 Orphan Drug Act.

The Orphan Drug Act has long been considered a success for encouraging the production of hundreds of drugs for rare diseases. But the law’s very success has raised economic concerns as the number of high-priced drugs for rare diseases has grown.

The review found that orphan drug spending in the United States totaled $15 billion in 2007 and $30 billion in 2013, an increase from 4.8 percent of total pharmaceutical spending to 8.9 percent. The current study projects orphan drug spending will remain fairly stable as a proportion of total drug spending. That stands in contrast to other published reports that estimate orphan drugs will account for 20 percent of worldwide spending on drugs (other than generics) by 2020.

The rise in orphan drug spending since 2007, Divino said, was caused by an increase in the number of orphan drugs approved by the Food and Drug Administration. The number of orphan drug approvals increased from 16 in 2007 to 33 in 2013, the analysis’ time period.

The Health Affairs article is the latest in a growing debate about the causes of high prescription drug prices and how orphan drugs may play a role. Drugs that win orphan approval have been cited for commanding premium prices, costing up to $300,000 per year or more, according to market research reports.

The Orphan Drug Act provides a seven-year exclusivity period that blocks competition and other financial incentives to companies that develop drugs for diseases that affect fewer than 200,000 people.

The pharmaceutical industry’s interest in orphan drugs has escalated in recent years and, increasingly, doctors and researchers have raised questions about unintended consequences of the act.

Celgene has been one of the top beneficiaries of the orphan drug law. The company’s flagship drug Revlimid, which has orphan status for multiple myeloma and many other cancers, had sales of $5.8 billion in 2015. Evaluate Ltd., a London-based research firm, forecasts that Celgene will become the No. 1 orphan drug company in world, as measured by sales, in 2020.

“When those financial incentives become sort of an investment opportunity to take advantage of the Orphan Drug Act. That’s a huge, huge concern,” said Clare Krusing, a spokeswoman for America’s Health Insurance Plans, a national association for health insurance companies. AHIP released a paper in August that questioned prices on orphan drugs when they were being used outside of their approved orphan indication.

For the Health Affairs paper, Divino and her team narrowed their analysis to orphan drug spending on drugs when they were used only on the rare diseases they were approved to treat under the act. The researchers used a database estimated to represent 98 percent of overall U.S. sales.

“The number of orphan drugs is increasing but when we look at this line of the actual spending and the forecast as well … yes, there is growth but it’s a consistent linear trend,” Divino said.

Still, the authors’ write, “in a broader context, drug expenditures are minimal when considered as part of total health care expenditures.” Total orphan drug spending represented approximately 1 percent of total U.S. health care spending, according to the authors.

Divino said the study’s focus was on aggregate spending and they didn’t look at the effect of orphan drug prices on individual patients.

In an email statement, the pharmaceutical industry trade group PhRMA, said the study “reinforces that the overall impact of orphan medicines on payer budgets is relatively small and contrary to rhetoric, the percentage of medicines with both orphan and non-orphan indications is small.”

But AHIP and others say that not including the cost of orphans when they aren’t used to treat rare diseases skews the pricing issue for patients.

“It’s not really the true orphans we worry about. It’s about the other types of gaming and abusing the orphan drug act which drives up expenditures,” AHIP’s Krusing said.

Researchers at Johns Hopkins Medicine called on lawmakers last year to close loopholes in the act, saying the law’s financial incentives encouraged high prices and motivated companies to apply for orphan designation even when a drug is known to treat more common conditions.

The paper, published in the American Journal of Clinical Oncology, noted that seven of the top-10 selling drugs worldwide in 2014 had received orphan status. Those listed included popular drug such as Crestor, a cholesterol fighter, and Humira, for rheumatoid arthritis and Crohn’s disease.

“There are a lot of factors I think that have come up in pricing in general, but what people are getting a glimpse of is the sheer greed,” said Dr. Martin Makary, an author of the 2015 paper and professor of health policy at Johns Hopkins School of Public Health.

Kaiser Health News is an editorially independent news service supported by the nonpartisan Kaiser Family Foundation. Follow Sarah Jane Tribble on Twitter: @sjtribble.

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Sorry, kids. Your pediatrician will probably give you the flu vaccine in the form of a shot this year.

The American Academy of Pediatrics said Tuesday that it doesn’t recommend using the flu vaccine that comes as a nasal spray. That’s because the federal Centers for Disease Control and Prevention looked at its performance last year and concluded it wasn’t up to snuff.

The CDC’s Advisory Committee on Immunization Practices found that FluMist was only 3 percent effective in children aged 2 through 17 during the previous flu season. “This 3 percent estimate means no protective benefit could be measured,” the committee reported. In comparison, injected flu vaccines protected about two-thirds of the children in this age group.

The CDC officially accepted that committee’s recommendation on August 26, but didn’t go out of its way to announce the policy. It posted its recommendation on a website.

The American Academy of Pediatrics is now following suit, with recommendations that go out to doctors who tend to the nation’s youngsters. “The AAP recommends annual seasonal influenza immunization for everyone 6 months and older, including children and adolescents,” the statement reads.

The group notes that 85 children died from the flu in the United States during the recent season, based on CDC figures. Most had not been vaccinated.

The American Academy of Pediatrics says most children will need a single shot. But children new to flu vaccinations will need two doses, four weeks apart. So a double sorry to you.

The pediatricians also recommend flu vaccination for all health care workers and women who are pregnant, considering pregnancy or breastfeeding during the flu season.

The nasal spray vaccine has more fans than the inoculation that comes in a syringe, for obvious reasons. So this turn of events is not simply a disappointment to the manufacturer, AstraZeneca. In fact, the manufacturer took issue with the CDC committee’s recommendation, to no avail.

In a statement emailed to Shots, AstraZeneca said it expects limited demand for FluMist in the U.S. but will make sure the vaccine is available in case some doctors request it.

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It’s ladies night at the Centennial Gun Club in a suburb of Denver. More than 80 women are here for safety instruction and target practice.

Tonight the club is offering more than shooting, though. The women rotate through the firing range, and in another large room, they hear a sobering presentation from emergency room doctor Emmy Betz. She’s part of a collaboration between gun shops and public health leaders in the state to help prevent suicide.

“If you’ve been touched by suicide somehow, if you could, raise your hand,” she asks. About half the hands go up.

Colorado has the nation’s seventh-highest suicide rate. In a typical year, more than half involve guns. Research suggests suicide is often an impulsive act, Betz says, and attempts are much more likely to be lethal when a firearm is used. If people survive a suicide attempt, they are far less likely to eventually die from suicide.

“Unfortunately, with firearms typically there’s not that second chance,” she says.

There’s a new push in the national conversation about gun violence that is attempting to sidestep the political rancor, to find common ground on one thing — guns and suicide. The campaign in Colorado is called the Colorado Gun Shop Project.

Centennial Gun Club is one of 46 on board. The project formally started in the summer of 2014, modeled after a similar one by the New Hampshire Firearm Safety Coalition.

During Betz’s talk, organizers hand out Life Savers candies to drive home the message. Gun owner Lily Richardson says she thinks the information could do just that: save lives. “I think those who are aware and taking the initiative to talk about it can help make the difference,” she says.

Nancy Dibiaggio, a new gun owner, agrees. “It’s a big issue, and I think it’s great Colorado is jumping on the wagon with this.”

Dick Abramson, Centennial’s owner, says he welcomes the opportunity to facilitate the discussion. “The difficulty is that it’s not a topic people want to just bring up and talk about over the cocktail table, right?”

He says workers at his store have refused to sell a gun to someone they’re concerned about or feel is having an especially bad day. “My honest feeling is this is a nonpartisan issue,” he says. “This is something that everybody can get behind. It should be a universal concern of everyone.”

In another Denver suburb, the Bristlecone Shooting, Training and Retail Center is also part of the project. At its range, shooters take target practice at bowling pins lined up on the far wall.

In the shop’s showroom, store owner Jacquelyn Clark shows off literature on display “that talks about suicide prevention and what to do if somebody you know or you yourself are in crisis,” she says.

A poster reads, Gun Owners Can Help! Under a photo of a lone elk in the mountains, it lists signs someone may be suicidal and a phone number for the National Suicide Prevention Lifeline.

Clark says there’s now an 11th commandment on gun safety rules: Consider off-site storage — family, friends, some shooting clubs, police departments or gun shops — if a family member may be suicidal. Clark says most people don’t realize that the majority of gun deaths are not homicides but suicide.

A survey of hospital emergency rooms by the Centers for Disease Control and Prevention in 2011 found an estimated 21,175 suicides involving firearms compared with 11,208 homicides involving guns.

“The gun community itself is more at risk than the regular community, not because gun owners tend to have more mental health issues but just because they have more access [to firearms],” Clark says.

Jarrod Hindman, director of the Suicide Prevention Resource Center in Colorado, says he appreciates that local gun advocates are taking the lead. “This is their project,” he says. “We’re just helping to facilitate the process.”

More than 500 Coloradans took their own lives with a firearm in 2014, says Hindman, but talking about the role of guns is hard.

“Obviously this is a very contentious topic, and we’ve found a way to find middle ground in a topic where we didn’t think there was a middle ground,” he says.

And now, a large trade association for the firearms industry, the National Shooting Sports Foundation, is teaming up with the American Foundation for Suicide Prevention to develop a suicide prevention campaign for the gun group’s 13,000 members. Their goal is to reduce the annual suicide rate by 20 percent in the next decade.

This story is part of a reporting partnership with NPR, Colorado Public Radio and Kaiser Health News.

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Consumers and lawmakers pushing for cheaper alternatives to the EpiPen, an antidote for life-threatening allergic reactions, and other high-priced drugs are seeking answers about a stubborn backlog of generic drug applications at the Food and Drug Administration.

Even after the agency started levying user fees on drugmakers in 2012 to pay for more people to review the medicines, the backlog of decisions still stretches almost four years.

As of July 1, the FDA had 4,036 generic drug applications awaiting approval, and the median time it takes for the FDA to approve a generic is now 47 months, according to the Generic Pharmaceutical Association, a trade group. The FDA has approved more generics in the past few years, but a flood of applications has added to the problem.

By comparison, the European Medicines Agency, Europe’s version of the FDA, has just 24 generics, including biologically based biosimilars awaiting approval. The FDA’s generic count doesn’t include biosimilars, which are more complicated medicines to review. The EMA along with the European Commission, which handles approval of marketing materials, are approving generics and brand-name drugs in about a year on average, according to the EMA.

Critics say getting generic alternatives to the U.S. market for products like EpiPen is still taking far too long. Other off-patent drugs with rising prices and no generic competition have also drawn scrutiny, including Turing Pharmaceuticals’ Daraprim, for toxoplasmosis, and Valeant’s cardiovascular drugs Isuprel and Nitropress.

Congress asks why generic version of EpiPens aren’t available

“We are concerned that Mylan (maker of the EpiPen) has not faced much competition for its product,” five U.S. senators wrote Aug. 24 to FDA Commissioner Dr. Robert Califf, adding that one of EpiPen’s nongeneric competitors, Auvi-Q, was recalled in October, granting Mylan a near monopoly. “News reports indicate that generic versions of the EpiPen have been subject to additional questioning by the FDA and have yet to be approved.”

On Monday, three members of the House Committee on Energy and Commerce wrote a similar letter to the FDA, seeking information about the EpiPen generic applications it has received and how they’ve been prioritized.

When asked whether the FDA bears any responsibility for the lack of EpiPen competition, FDA spokesman Kristofer Baumgartner said he couldn’t comment on pending applications or confirm their existence, citing confidentiality rules. But he stressed that the FDA pushes pending applications for drugs with no current generics to the front of the line and approved 580 generics in 2015, a record for the agency and 40 percent more than in 2014.

“The FDA is confident that the overall trend in actions on generic drug applications will be one of continuing improvement,” Baumgartner said.

In March, generics giant Teva Pharmaceuticals told investors that its generic version of EpiPen was rejected by the FDA, and that it wouldn’t be able to launch the generic until at least 2017. Adamis Pharmaceuticals reported a similar rejection from the FDA for its EpiPen generic in June.

Mylan has said it will offer a $300 generic in the coming weeks. Because Mylan also makes the brand-name product, it won’t have to wait in line behind other pending generics.

Dr. James Baker, the CEO and chief medical officer of the advocacy group Food Allergy and Research Education, said Mylan’s move may deter other generic manufacturers from seeking approval. Adrenaclick is the only other epinephrine auto-injector on the market, but it isn’t an exact generic of EpiPen and can’t be swapped automatically at the pharmacy if a doctor has written a prescription for EpiPen.

Adrenaclick also isn’t widely available. “You call up 100 pharmacies, and maybe 10 have the device, from what we gather,” Baker said of Adrenaclick.

He said several factors have allowed EpiPen’s price tag to swell over the years. Many patients were in the dark about EpiPen price increases until insurers started shifting more of the cost onto consumers a few years ago, and getting approval for a generic that’s both a drug and a device is more complicated than getting approval for a drug alone, he said.

Meanwhile, Mylan has aggressively marketed its product and raised doubts about alternatives.

And documents show that Mylan submitted a citizen petition to the FDA arguing that people trained to use EpiPens wouldn’t be able to use Teva’s pending generic epinephrine auto-injector because of design differences.

“Is Mylan doing anything illegal? No,” Baker said. “It’s taking advantage of all these things to take the market and basically push it to an extreme.”

User fees levied to speed up the approval process

The FDA’s generic backlog isn’t a new problem. In 2012, it was so large that it prompted the government to start charging user fees to generic manufacturers to provide the funds for the FDA to speed the process. The fees built on the 20-year-old Prescription Drug User Fee Act, which required brand-name drugmakers to pay fees to expand FDA’s capacity to review applications for those medicines. In the first three years, the FDA collected $1 billion from generic drug manufacturers.

The fees were used to hire an additional 1,000 employees, and put the Office of Generic Drugs on par with the Office of New Drugs by reorganizing it and moving it from four outlying buildings to the FDA’s main campus in Silver Spring, Md.

The funds were also used to upgrade the office’s information technology. The FDA says on its website: “Additional resources will enable the Agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.”

In October 2012, there was a backlog of 2,868 generic drugs awaiting approval, and the FDA said it would take a “first action” on 90 percent of these drugs by 2017. This summer, the agency met its goal a year early, but a first action isn’t an approval. Instead, it stops the review clock and puts the applications back in industry’s court.

Only 1,551 generics have been approved since the fees on drugmakers were initiated, and that total includes some extra applications that weren’t considered part of the official backlog. So, all told, the agency has only approved about half of the backlogged generics that were awaiting approval in 2012.

“Most applications from the backlog will need to come back to FDA for additional review due to deficiencies in the submissions, before approval is possible,” the agency said in a statement in responses to questions.

David Gaugh, senior vice president for science and regulatory affairs at the Generic Pharmaceuticals Association, said standards used to compile generic applications when they were submitted three or four years ago have changed while the applications were sitting in the backlog. So when the FDA got back to those companies, it said the applications were of “poor quality.”

The applications for generic drugs have continued to pile up even as the FDA approved a record number of generics in 2015 and again in the first seven months of 2016. The number of generic drug applications tripled from 2002 to 2012, according to January congressional testimony from Janet Woodcock, who directs the FDA’s Center for Drug Evaluation and Research.

Still, some see signs the agency is on the right track.

“I think that it is an optimistic picture overall … at the FDA, there’s been a lot of progress, and I think there is more to be made,” said Dr. Aaron Kesselheim, an interdisciplinary drug researcher at Harvard Medical School and Brigham and Women’s Hospital. “This is not something that people should think has been solved at this point. It’s totally an ongoing process.”

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Follow Sydney Lupkin on Twitter: @slupkin.

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