A San Francisco fertility clinic says that a problem with the liquid nitrogen in one of its storage tanks may have damaged thousands of frozen eggs and embryos, triggering calls and letters to more than 400 concerned patients of the Pacific Fertility Center.

The nitrogen level in one tank fell very low, according to Dr. Carl Herbert, the fertility clinic’s president. Herbert told ABC News that an “emergency filling” immediately took place, and that the tank’s contents were then transferred to a fully functioning tank.

The problem struck on March 4 — the same day that a similar cryogenic tank failure was reported in Cleveland, where the University Hospital Fertility Clinic is investigating “an unexpected temperature fluctuation” that jeopardized its tissue storage bank, where liquid nitrogen preserves eggs and embryos. That incident reportedly affected some 700 patients.

In San Francisco, Dr. Herbert said the clinic is working to determine the effects of the tank failure. Herbert said a “substantial number” of the clinic’s patients had stored embryos for around 8-10 years, according to ABC.

“The good news is, we have viable embryos — we’ve proven that from that tank,” Herbert said. “So my hopes are that for my patients, they’ll be OK. But because there’s an unknown, it’s extremely stressful.”

The clinic’s price for freezing eggs starts at $8,345, and in-vitro fertilization is $11,595, according to its website. The annual cost for tissue storage is $600.

Emotions have run high during calls with affected patients, Herbert told The Washington Post.

“Anger is a big part of the phone call,” Herbert said. “Our goal is to provide all the patients we see with some kind of a family. . . . We need to think: If this tissue doesn’t work, what are the next steps, and have you not feel defeated.”

The Pacific Fertility Center is located in San Francisco’s North Beach region; in the past, it has said that its patients include families of employees at Facebook and other tech companies, many of which pay the costs of fertility treatments as part of their health coverage.

After the Cleveland incident, the American Society for Reproductive Medicine released a statement saying that the cryogenic failure and “potential loss of eggs and embryos at University Hospitals Fertility Center in Cleveland is a tragedy.”

A family that lost embryos in the Cleveland hospital’s nitrogen tank failure has filed a class-action lawsuit, the AP reports.

Let’s block ads! (Why?)

Please sign up here to subscribe to WBUR’s CommonHealth newsletter highlighting important stories about health and medicine.

It all began with a single X-ray.

It was 1974, and surgeons had been doing total hip replacements for a dozen years.

“Total hip replacement is an absolutely magnificent operation,” says Dr. William H. Harris, “and we were able to do remarkable things to restore mobility and relief of pain and the joy of life to countless individuals.”

As chief of Massachusetts General Hospital’s joint replacement surgery service, Harris was sent a mystifying patient, a prominent lawyer from San Francisco whose hip replacement had gone badly awry.

“I had never seen anything like this before,” he recalls. “The bone around his prosthesis, around his total hip, had been completely destroyed. It was just astonishing. And I thought it had to be cancer.”

But under the microscope there was no cancer, no recognizable disease of any kind. It was something much stranger.

So begins the twist-filled backstory of disaster averted that Harris tells in his new book, Vanishing Bone: Conquering a Stealth Disease Caused by Total Hip Replacements.

Now 90, Harris holds an endowed professorship of orthopedic surgery at Harvard Medical School. He was chief of joint replacement surgery at MGH for 30 years. And he’s one of the doctors and researchers that grateful recipients of artificial hips may want to thank.

Those patients are legion: At least 3 million Americans have artificial hips, and millions more around the world.

Back to his tale: No visible cancer. The only type of cells to be seen on the ruins of the bone were a sort of cleanup cells, called macrophages. And they were stimulating another kind of cell, called an osteoclast, which means “bone-eater.”

“This was the only cell in the body that could eat bone and it was actively and aggressively eating the bone,” Harris explains. “It became a medical detective mystery: What in the world is this disease and how does it come about? Why is it there?”

The question quickly became even more urgent, because soon it wasn’t just one patient or two whose replacement hips were being attacked by this bone-eating disease. It was thousands — then hundreds of thousands. The longer people had their replacement hips, the higher the risk. In some, their bones became so weak, just walking could make them snap.

“Over time, it began to involve so many people that around the world there were a million people with this condition,” Harris says. “By 1990 it was clear that it was the No. 1 problem in total hip replacement surgery and the No. 1 cause of failure.”

One of the first possible culprits to come under suspicion was the “bone cement” — the glue used to affix the artificial joint to the patient’s skeleton. Tiny bits of the cement seemed to be triggering the odd response by the cleanup cells and the osteoclasts.

So Harris and others devised techniques to replace hips without using cement. And they heaved a sigh of relief, he says, thinking they’d solved the problem. Only to find, when he reviewed his first hundred cases of a cementless hip replacement — “Bingo, the very same disease.”

But they were on its trail. The problem wasn’t just the bone cement, they realized, it was that tiny bits of plastic could eventually trigger the osteoclasts to eat bone. And those bits of plastic were coming from the inevitable wear on the plastic at the replacement joint as the patient logged millions of steps.

“This caused a big shift in our thinking, and the problem shifted from being a problem of medical detective work to find out what in the world is going on, to innovation — material science,” Harris says.

Harris and other researchers needed to figure out how to make an artificial hip joint that could take a load of hundreds of pounds, for millions of steps, without wearing down enough to release the particles of polyethylene plastic. And to do that, he decided, he needed a machine that could simulate what happens to hips in the body.

It took three years and plenty of frustration to build an accurate hip simulator. Meanwhile, his team gained a pivotal insight from using a powerful scanning electron microscope to look at the replacement hips of patients who donated them back to his lab after death: It was the process of walking that modified the polyethylene.

The polyethylene plastic on the hip implants was an extraordinarily long molecule. Harris compares it to a very, very long, very, very thin string of spaghetti. And normally, the plastic is like a bowl of spaghetti that is unorganized, with the strands going in all different directions. But not in the hips from the deceased patients.

“We found that all of the strands of the polyethylene were lined up in a row,” he says. “The polyethylene molecules had been changed in their position. They’d been modified by the fact that gait simply goes back and forth, and forth and back. And that lines them up.”

Harris turned to his friend Ed Merrill, a professor emeritus of polymer chemistry at MIT, and asked if he could stop this reorientation from happening.

“He said, ‘Sure,’ and I said, ‘I love it, that’s wonderful, tell me about it. How are you going to do it?’ ‘Well,’ he said, ‘we do that for a lot of molecules. We get them to be fixed in their position by putting in energy, and that energy then links one of the molecules to the next one.’ “

It’s a process called cross-linking, used on many materials. Merrill suggested using an electron beam to cross-link the polyethylene in artificial hips. When Harris and his team tried it, they ran into a few problems at first, the most striking of which was that the plastic exploded.

“Sometimes it didn’t explode, sometimes it just caught fire,” Harris says. “And at other times it simply melted. But clearly we were in a difficult spot. It took a lot of work to figure out what that problem was.”

The problem turned out to be a matter of too much energy. They needed to slow the electron beam down so it wouldn’t “overcook” the plastic. Once they figured that out, they could test it. The results: “We could detect no wear at all. Zero wear. We thought it might reduce wear, it might make it better. It made it almost perfect.”

There’s a lot more to the story in Vanishing Bone. It wasn’t enough to invent the new plastic; it had to be patented and licensed, approved by the Food and Drug Administration, and manufactured — all of those steps involved additional challenges. But in late 1998, the first patient got a hip made with the new plastic.

Fast forward nearly 20 years, “and there are probably now 7 million people around the world walking on this material in total hips and in total knees,” Harris says. “The disease is virtually gone.”

So that’s certainly a happy ending, but what’s the moral of the story? For Harris, it serves as an example of contemporary medical science — “how it works, warts and all, the complexity, the need for persistence.”

And, he says, it highlights the special joy of being a doctor and a scientist: “I loved taking care of patients and I loved going to the operating room, but I also hate failure. And my own failures in the operating room would lead me to say, ‘Let’s take this failure up to the laboratory and see if we can’t unscramble it, unlock it, and find a way to do it better.’ “

So, at age 90, has he replaced a hip?

No, he says, but if he needed to, he’d feel quite relaxed about it. Because he’d know that his new hip could be made of cross-linked polyethylene.

The first version of this story appeared on WBUR’s CommonHealth. Carey Goldberg, who covers health and science, is the host of CommonHealth.

Let’s block ads! (Why?)

One shred of solace that surfaced as hurricanes and tropical storms pummeled Texas, Florida and Puerto Rico last fall was the opportunity to see drones realize some of their life-saving potential.

During those disasters unmanned aircraft surveyed wrecked roads, bridges and rail lines. They spotted oil and gas leaks. They inspected damaged cell towers that had left thousands unable to call for help. “Drones became a literal lifeline,” former Federal Aviation Administration chief Michael Huerta told the agency’s drone advisory committee in November.

The drones used needed a special exemption from a set of FAA rules, known as Part 107, that normally require small drones to fly below 400 feet, stay within the operator’s visual line of sight and avoid populated areas.

These regulations make it hard for commercial drones to operate in the United States. But last October the Department of Transportation took a big step: It invited state and local governments to partner with universities and companies on tests to speed the integration of drones into the national airspace. The FAA is reviewing 149 proposals and plans to choose five to 10 by mid-May.

The proposals cover a wide range of applications. Many of them are health-related. “I am confident that one-half or more of all the applicants have put some element of medical support in their proposal,” says John Walker, a Lancaster, Penn.-based aerospace consultant who spent 32 years at the FAA before co-founding the Padina Group, Inc in 2006.

Walker believes early public acceptance of drone delivery networks in urban areas will revolve around hospitals. And once drones can safely and reliably carry blood and medical supplies, that will pave the way to other kinds of drone deliveries. “That linear network where drones can operate between hospitals … would also have Amazon and anyone else that could meet the requirements to operate,” Walker says.

Several companies have approached governments in developing countries about performing medical deliveries in areas with great need, poor roads and less crowded skies.

In late 2016 Zipline, a San Francisco Bay Area-based robotics startup, set up distribution centers in Rwanda, where its drones had made more than 1400 flights carrying on-demand blood and emergency supplies over 62,000 miles as of last fall. This year the company will expand its medical delivery operations by launching a second base in Rwanda and new service in a larger neighboring country, Tanzania.

Last October Swiss Post launched a medical transport network in Lugano, Switzerland, using drones made by another Bay Area company, Matternet. So far the drones have made 350 deliveries, about 5 to 15 per day. Other groups have also brought aircraft abroad to attempt health-related deliveries, but those demo flights have not become sustained operations.

Such efforts face tougher hurdles here in the U.S. where regulations focus on safely integrating drones into already congested national airspace. “We haven’t seen [the FAA] be interested in a one-off approach,” says Susan Roberts, co-founder of AiRXOS, a General Electric subsidiary focused on drone infrastructure technologies. “It doesn’t do anybody any good for a delivery company to be able to fly from two specific points if they can’t then scale that over and over again.”

Beyond blood and medical supply deliveries, drones could transform another key component of healthcare — lab tests. Timely test results help doctors diagnose infections and reduce guesswork in prescribing medications. Some of those decisions have life-or-death implications. For example, newborn babies turn yellow from jaundice as their bodies make bilirubin, a byproduct formed during normal breakdown of red blood cells. But “very high bilirubin can be toxic to babies,” says Dr. Geoff Baird, a clinical pathologist at the University of Washington in Seattle.

Of the millions of blood samples, urine specimens and swabs his team processes each year, most reach central lab facilities by car. “We have cars going seven days a week, many times a day, up and down the state of Washington on freeways, across the passes, in the mountains,” Baird says. The university also does testing for out-of-state hospitals and several clinics in rural communities on the San Juan Islands off the northwest coast of Washington. Getting lab samples from the islands down to Seattle hospitals for testing requires multiple stops by car, plane and ferry — a journey of about 100 miles that often takes more than 24 hours, even longer on weekends.

But samples carried over the Puget Sound on a drone from the San Juan Islands could reach the main lab in Seattle in 90 minutes, Baird says. That’s why the university was eager to put in a bid for the FAA program.

The proposed medical deliveries are part of a larger application submitted by Washington’s Department of Transportation, which includes other companies such as Amazon and T-Mobile. If selected, Baird says the San Juan efforts will use drones developed at Tuscon, Ariz.-based Latitude Engineering. Latitude makes the military-grade aircraft that Johns Hopkins researchers used to set a distance record carrying refrigerated blood samples ~160 miles in a 3-hour flight across the desert.

North Carolina’s Department of Transportation also applied to the FAA program wanting to use drones for medical deliveries. Zipline and Matternet are on that application as well as several other undisclosed proposals. Matternet is also partnering with the city of Palo Alto on a proposal to shuttle blood to Stanford hospitals. Flirtey, a drone manufacturer in Reno, Nev., is focusing on using its aircraft for last-mile delivery of defibrillators — devices the company thinks could save hundreds of thousands of lives in America each year, by increasing the chance of survival from out-of-hospital cardiac arrest.

Ultimately, though, what makes or breaks a proposal isn’t likely the whiz-bang drones but rather the underlying infrastructure that ensures they can fly safely alongside commercial jets, helicopters, balloons and everything else in the sky.

Toward that end, at a drone symposium held earlier this week in Baltimore, the FAA stressed its interest in “sense and avoid” technologies to prevent drone crashes, and systems that allow drones to be identified and tracked remotely. GE’s projects cover both areas. “No one company is going to solve everything. We’re taking a holistic approach,” Roberts says. “We need to help the medical deliveries, we need to help the inspectors, we need to help people who are just taking pictures of houses.”

The United Nations Children’s Fund is working to foster this all-inclusive spirit at the global level. Last summer, UNICEF worked with local governments in the African country of Malawi to launch a drone corridor for companies, universities and nonprofits to fly test missions there.

More recently, UNICEF invited groups to transport vaccines in Vanuatu, the South Pacific nation made up of roughly 80 islands east of Australia. The drone corridors run on a barter system, says Chris Fabian, who leads UNICEF’s venture capital arm. “If you come and use our time, create something that’s open-source and useful for everyone else.”

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

Let’s block ads! (Why?)

No, you can’t.

That’s what federal officials told Idaho regulators and the state’s governor late Thursday regarding the state’s plan to allow insurers to sell health plans that fall short of the Affordable Care Act’s requirements.

But the letter from the Trump administration did offer an alternative: Tweak your plan a bit to make them qualify as “short-term” policies. These alternatives, which offer coverage for a limited time, are exempted from ACA rules — including the rule that bars insurers from rejecting people who have pre-existing medical conditions.

“On the one hand, they’re saying they’re going to enforce the ACA,” says Sarah Lueck, a senior policy analyst at the Center on Budget and Policy Priorities. But, Lueck adds, the Health and Human Services Department also seems to say, ” ‘if you want to roll back protections for people with pre-existing conditions, we have some ideas for you.’ And that concerns me.”

Idaho’s approach, announced in January, would have allowed insurers to offer “state-based” insurance plans that did not include some of the ACA’s consumer protections. A few weeks later, Idaho Blue Cross jumped in with five “Freedom Blue” state-based plans it hoped to sell.

Regulators in other states were watching the Idaho situation. Its move was viewed either as a brazen effort to flout federal law or an innovative attempt to stabilize the market. Regardless, Idaho’s action meant the Trump administration had to take a position: Enforce the ACA or look away.

Here are four key takeaways from the administration’s response to Idaho, and how the ruling may play elsewhere.

States and insurance carriers can’t ignore federal law

Although Thursday’s letter from Seema Verma, head of the federal Centers for Medicare & Medicaid Services, commended Idaho’s effort to “address the damage” caused by the ACA, it said that, as proposed, the state-based plans would violate at least eight of the federal health law’s provisions. For example, the ACA forbids insurers from charging sick people more for a policy than it charges those who are considered healthy; it bans the establishment of annual or lifetime coverage caps; and it won’t allow insurers to reject applicants who have pre-existing conditions.

Verma’s letter noted that if plans that don’t meet ACA standards were sold in Idaho, insurance carriers might face significant financial penalties. Health policy specialists say they would be surprised if insurers would want to take that risk.

“It’s one thing for the state to take on the CMS, but quite another for carriers,” says Jan Dubauskas, general counsel for the IHC Group, which sells short-term health insurance nationally. “When I heard that, I thought, ‘This is the end for state-based plans.’ “

But Idaho Gov. Butch Otter, a Republican, has been upbeat, saying the letter from Verma “was not a rejection of our approach,” but “an invitation … to continue discussing … what can and cannot be included in state-based plans.”

Late Friday, Idaho Blue Cross issued a statement expressing disappointment in the CMS decision, but also echoing Otter’s willingness to move forward.

The timetable going forward is not immediately clear, although both federal regulators and state officials say they are willing to talk about alternatives to Idaho’s original proposal. Following Verma’s suggestion to get new short-term plans on the market would also require Idaho’s insurers to consider their options, modify the plans and come up with new premium rates — all of which takes time.

Short-term plans get another boost

Dubauskas and others say the Idaho decision could increase interest in short-term plans.

Such policies have been sold for years, meant as a stopgap for people between jobs. They are less expensive than ACA plans, mainly because they are allowed to reject people who have health conditions (or exclude coverage for such conditions) and have other limitations.

Most short-term plans don’t cover treatment for substance abuse or mental health issues; few cover maternity care and some don’t include prescription drug coverage. They generally can’t be renewed — meaning consumers must reapply and answer medical questions each time their policies expire.

The Obama administration, fearing that short-term plans would suck relatively healthy people out of the ACA market, limited such policies to 90-day terms. The Trump administration, however, has proposed allowing short-term plans to last for up to a year. These final rules aren’t expected for at least another two months.

Ironically, Idaho Insurance Director Dean Cameron had in January promoted the more robust “state-based” plans — like those the Blues insurer wanted to sell in Idaho— as an alternative to short-term coverage.

After getting the CMS letter, Cameron told the Idaho Statesman newspaper that short-term plans might be easier for the Trump administration to handle legally, but could cause consumers more problems than what Idaho had proposed.

Critics fear that consumers will buy such plans without understanding their limitations.

“They might think it’s health insurance like they’re used to,” Lueck says. “But it’s really not. It’s really very bare-bones.”

State reactions will vary widely, creating different rules around the country

Even if the Trump administration’s proposal to extend short-term coverage to a full year is finalized, states can set stricter rules.

A handful of states already do.

New York and New Jersey require many of the same rules as the ACA for policies sold in their states. But insurers won’t sell short-term plans there.

Four states — Arizona, Michigan, Minnesota and Oregon — limit the length of short-term plans sold in their states to 185 days, according to a survey by the Commonwealth Fund and researchers at Georgetown University.

“A small group of largely blue states have some regulation [of short-term plans], but not very many,” says Sabrina Corlette, a research professor at Georgetown University’s Health Policy Institute. “It’s possible that if this rule is finalized we will see more states start to step up and regulate short-term markets.”

Conversely, lawmakers in other states may promote short-term coverage as a lower-cost alternative to the ACA — although people with pre-existing conditions may not be able to buy such plans.

“Politically, short-term plans have some appeal because lawmakers can say now there’s a cheaper option out there,” Corlette notes.

The increased emphasis on short-term plans could increase premiums

Actuaries fear that short-term plans — or state-based plans like those rejected in Idaho — would drive up costs for people who remain in more comprehensive ACA coverage.

That’s because younger and healthier people might be tempted to drop their ACA coverage, leaving only those who are older, sicker and costlier in the remaining pool. That, in turn, drives up premiums — affecting millions of Americans who don’t receive subsidies and already struggle to pay for their health insurance.

But just how many people would jump to new, short-term coverage?

The Trump administration has estimated that about 100,000 to 200,000 people with existing ACA coverage would make the shift, while other specialists in health insurance suggest higher numbers.

Christopher Condeluci, a Washington, D.C., attorney who specializes in employee benefits and previously served as the tax and benefits counsel to the U.S. Senate Finance Committee, says it’s unclear which estimates are correct.

The real issue to keep in mind, Condeluci says, is that an increasing number of people who don’t get subsidies are already choosing to either forgo coverage or pick an alternative, such as a short-term plan.

“People are voting with their feet,” he said. “That cannot be overlooked.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. You can follow KHN senior correspondent Julie Appleby on Twitter @Julie_Appleby.

Let’s block ads! (Why?)

Last Saturday, while I was visiting Fatty’s Tattoos and Piercings, a college-aged woman in a hoodie walked in and asked for a tattoo, her first, right on the spot.

“I want a red-tailed hawk feather,” she told the artist on duty at the Washington, D.C., tattoo parlor.

He peppered her with questions: How big? What style? She alternated between a blank stare and a furrowed brow: “I … have a photo on my phone of the feather that I like, I could show you that?”

The artist rubbed his beard and told her he didn’t do realistic tattoos. Maybe they should set up an appointment for her sometime next week, with another artist, he offered. Between the lines, he seemed to say, “This will be permanent, so I don’t want to give you the wrong tattoo.”

But considering how many changes skin weathers — burns heal, scars fade and wrinkles set in — it’s sort of unbelievable that tattoos do stick around.

Recently, a group of French scientists looked into how that works, hoping to use the knowledge to improve tattoo removal.

So, first, of course, they gave some mice tattoos.

The mice didn’t get Mom tattoos on their tiny biceps. Instead, they got tail tats — three stripes of green ink — for researchers to study.

“The thing is, the mouse skin can be super fragile, much more fragile than human skin,” says Sandrine Henri, an immunologist at the Centre d’Immunologie Marseille-Luminy.

If you zoom way in on any tattoo, it’s really just a bunch of cells holding tight to ink particles. From the mice’s tail tattoos, Henri and her colleagues identified one type of cell that captured ink particles and stayed in place, the dermal macrophage.

The researchers thought they might be able to disrupt the tattoos by destroying the macrophages that had locked up the ink. So they engineered mice whose macrophages — and only those cells — would shrivel in the face of a specific toxin, and then injected that compound into these special, tattooed mice.

But it didn’t work.

The messed-up macrophages released their ink particles, but the color persisted. It turns out that new macrophages quickly took over the job of holding the tiny flecks of ink in place, and the mice kept their sporty green-striped tails.

But if it were possible, Henri says, to use an ointment, or a drug, to delaythose replacement macrophages,it might improve tattoo removal for mice — and humans. The researchers’ fingings appeared Tuesday in the Journal of Experimental Medicine.

To think about removing ink from human shoulders, rather than mouse tails, it helps to know how tattoos appear. In broad strokes, we understand this process, says Bruce Klitzman, a biomedical engineer at Duke who once worked on creating an erasable tattoo.

As a tattoo artist outlines a yin-yang symbol on someone’s shoulder, a solid needle loaded with ink pierces the tattoo-ee’s skin, or epidermis, and the needle’s exit lets pigment flow into a second layer of skin, the dermis, Klitzman says.

But any self-respecting immune system treats all visitors — including the ink particles meant to create a wolf’s face on your forearm — as unwelcome. So skin cells mount a multilevel attack on the ink particles.

First, the cells that weren’t hit by the tattoo needle block out guests, Klitzman says. Only a fraction of the ink an artist lays down actually makes it into the dermis, and this is also why new tattoos tend to leak ink as they heal.

Newly tattooed skin swells, the same way it would respond to any other wound, and blood and lymph ferry away the smallest bits of ink. For the remaining pigment particles, the next order of the immune system’s business is consuming the foreign invaders, to try to destroy them.

That’s where the macrophages, the cells Henri studied, come in. They’re specialized immune cells — their name means big eater in Greek — and their job is to slurp up interlopers, says Klitzman. “Macrophages can basically swallow many, many tattoo pigment particles, almost like a vacuum cleaner, just go along and suck up all those particles,” he says.

Usually, a macrophage digests the invaders it devours, using acid to rip its enemy apart. It’s a good strategy for killing bacteria and viruses, but not for tattoo pigments. Acid has little effect on the ink ingredients.

That means a macrophage that has gorged on ink has no way to finish its job. Eventually, the pigment-filled macrophages dial back their attack, content to contain the threat, even if they can’t completely neutralize it. “They just sit there like a full vacuum cleaner bag,” says Klitzman.

Another type of cell, called a fibroblast, is also known to take in some ink particles in human skin. Together, the macrophages and fibroblasts bind enough ink for the image of, say, a carrot or feather to appear on your calf.

Those cells and the pigment inside them can hang around for years. But all cells die eventually, which brought Henri and her team to their question: How do tattoos stay put as individual cells die?

Their work confirms that even when macrophages die and release their pigment particles, other macrophages quickly gobble up the ink, keeping it in place.

Even when the researchers grafted one mouse’s tail tattoo onto another mouse’s back, the second mouse’s own macrophages carried the skin graft’s tattoo. “The cells from the graft died and released the ink, and the host mouse’s cells captured it,” Henri says.

All of that, basically, underscores why tattoo removal is really, really difficult.

Laser removal is an option, says Jared Jagdeo, a dermatologist at University of California, Davis. Tuned to a wavelength specific to a tattoo’s colors, “lasers are able to break apart tattoo particles,” he says. The bursts of energy bust ink “from larger boulders into smaller rocks, and then into fine pebbles which then can be swept away by the lymphatic system.”

But laser removal is far from perfect. The process of blurring ink beyond recognition can take many sessions, spaced weeks apart, at a couple hundred dollars a visit.

Laser pulses irritate skin, and people show re-uptake of ink similar to Henri’s mice, Jagdeo says. He uses anti-inflammatory drugs to help tame that response, but it’s really difficult to remove all evidence of a tattoo. “Tattoos are at their baseline permanent, so if [someone gets] a tattoo they should plan on having it for a while,” he says.

Back at the tattoo shop, I don’t know if the woman with the red-tailed hawk feather ever managed to get her tattoo. Either way, I hope she’s happy with her decision. For now, tattoo removal is still a challenge.

Let’s block ads! (Why?)

When Erich McElroy takes the stage at comedy clubs in London, his routine includes a joke about the first time he went to see a doctor in Britain.

Originally from Seattle, McElroy, 45, has lived in London for almost 20 years. A stand-up comedian, he’s made a career out of poking fun at the differences in the ways Americans versus Britons see the world — and one of the biggest differences is their outlook on health care.

“I saw a doctor, who gave me a couple pills and sent me on my way. But I still hadn’t really done any paperwork. I was like, ‘This isn’t right!’ ” McElroy says onstage, to giggles from the crowd. “So I went back to the same woman, and I said, ‘What do I do now?’ And she said, ‘You go home!’ “

The mostly British audience erupts into laughter.

McElroy acknowledges it doesn’t sound like much of a joke. He’s just recounting his first experience at a U.K. public hospital. But Britons find it hilarious, he says, that an American would be searching for a cash register, trying to find how to pay for treatment at a doctor’s office or hospital. It’s a foreign concept here, McElroy explains.

Onstage, McElroy recounts how, when the hospital receptionist instructed him to go home, he turned to her and exclaimed, “This is amazing!”

Amazing, he says, because he didn’t have to pay — at least not at the point of service. In Britain, there’s a state-funded system called the National Health Service, or NHS, which guarantees care for all. That means everything from ambulance rides and emergency room visits to long hospital stays, complex surgery, radiation and chemotherapy — are all free. They’re paid for with payroll taxes. In addition, any medication you get during a hospital visit is free, and the cost of most prescription drugs at a pharmacy are cheap — a few dollars. (Private health care also exists in the U.K., paid out-of-pocket or through private insurance coverage, but only asmall minority of residents opt for it.)

Since the 2008 financial crisis, the U.K., like many countries, has been taking in less tax revenue — so it’s had to cut spending. Its expenditure on the National Health Service has still grown, but at a slower pace than before. That means drugs are now being rationed. Tens of thousands of operations have been postponed this winter. Wait times at the emergency room are up, says Richard Murray, policy director at the King’s Fund, a health care think tank.

“If the ER is really busy, it makes the ambulances queue outside the front door — not great,” Murray says. “And in some cases, the hospital is simply full.”

In recent months, there have been several “Save the NHS” marches across Britain, where thousands have demonstrated to demand improved care and more funding for the health system. One such march, on Feb. 3 on Downing Street in central London, caught President Trump’s attention.

Two days later, Trump tweeted that the NHS is “going broke and not working.” He accused Democrats of pushing for a similar system of universal health care in the United States. “Dems want to greatly raise taxes for really bad and non-personal medical care. No thanks!” the president wrote on Twitter.

That tweet offended many in Britain. It prompted Prime Minister Theresa May’s office to issue a statement saying the U.K. premier is “proud” of her country’s system. The U.K. health secretary, Jeremy Hunt, tweeted back at Trump, saying he may disagree with some of the claims of those attending “Save the NHS” marches, but that “not ONE of them wants to live in a system where 28m people have no cover” — a dig at the uninsured in America. Hunt wrote that he’s proud that Britons “all get care no matter the size of their bank balance.”

The National Health Service spends less than half of what Americans spend per person on health care, and yet life expectancy is higher in Britain.

Defense of the NHS runs straight across the British political spectrum.

“You wouldn’t find a single leading politician on either the left wing the Labour Party or the right wing in the Conservative Party that would talk about privatizing the NHS,” Murray says. “That would be electoral poison.”

The NHS polls better than the queen. U.K. politician Nigel Lawson once said “the NHS is the closest thing the English people have to a religion.” It featured prominently in the opening ceremony of the 2012 London Olympics, with doctors dancing to swing music and hospital beds arranged to spell out the letters N-H-S in aerial views from above.

Britain’s National Health Service celebrates its 70th birthday this summer. It was founded on July 5, 1948.

After the pain of World War II, Britons decided to provide health care for all, and they’re still very proud and protective of that choice, says Roberta Bivins, a historian of medicine at the University of Warwick.

“The war was barely over. The rubble was still smoking,” Bivins says. (She is also an American expatriate who’s lived in the U.K. since the 1990s, when she arrived to study for a Ph.D. She, too, describes being in disbelief the first time she went to a doctor and wasn’t asked to pay anything.)

“People here are very, very uncomfortable that companies should profit from someone getting sick,” she says. “In the U.S., we’re much more comfortable with the idea that the market will provide services.”

McElroy, the comedian, says state-funded health care means his family doesn’t have to worry about needing coverage through an employer. He and his wife Erin McGuigan are both self-employed. McGuigan works as a birth and postnatal doula, alongside NHS midwives. She gave birth to the couple’s two children, in the NHS system, for free.

“You get follow-up care, where the midwives and health visitors come to your home, for a number of days after you give birth, to do checks and ensure breastfeeding is established and [the] baby is well — just to get new parents on their way,” McGuigan says. “I’ve had excellent care.”

She says she has had to wait four to six weeks for a doctor’s appointment if it’s not something urgent.

McElroy says there is one thing he would like to change about the NHS. His comedy routine includes another joke about what happened after he had minor surgery in Britain.

“The first thing they gave me when I came out of surgery was a fish pie — which I say in the routine, put me straight back into the hospital, because it was so disgusting!” he says.

“They might give us health care,” he jokes, “but the food is still terrible in this country.”

Let’s block ads! (Why?)

A piece of legislation under consideration in Florida this week has received a lot of attention because of a controversial provision that would allow some teachers to have guns in schools. But the proposed law would also designate an influx of cash for mental health services.

The state has seen three mass shootings in 20 months — at the Pulse nightclub in Orlando, the Fort Lauderdale airport and now at Marjory Stoneman Douglas High School in Parkland. And the need for more mental health funding has come up twice before — with no cash forthcoming.

In today’s dollars, Florida is spending 40 percent less on mental health than it did in 2000, notes Melanie Brown-Woofter, president of the Florida Council for Community Mental Health.

“That means there are fewer providers or fewer sources that the individuals can access,” she says. And that lack of resources, she and other mental health providers say, undercuts the ability to catch mental illness early and treat it.

Since 2000, the state has increased funding for mental health services by $218 million. But that hasn’t kept up with inflation and the 4.5 million people who have moved to Florida since then, she says.

The shooting in Parkland shifted the focus of many people in Florida and nationally to mental health. President Trump and other leaders were quick to call the 19-year-old man who killed 17 people at his former high school mentally ill.

Gov. Rick Scott called for $500 million for school safety, including giving young people more counseling and crisis management. He brought it up at a recent stop in Tampa.

“Florida is never going to be the same — and we’ve got to make sure Florida is never the same,” Scott said. “We’ve got to make sure we have common-sense solutions to make sure every parent knows that their child is safe.”

The mental health provision is attached to controversial gun legislation passed by the Florida Senate. It raises the age of most firearm purchases to 21, institutes a mandatory three-day waiting period for all firearm purchases and bans the sale of bump stocks, devices that can be attached to a weapon to enable it to fire more quickly.

These provisions are not popular with many in Florida’s legislature, where many conservatives have opposed any restrictions on gun ownership in the past. On the Democratic side of the aisle, there is opposition to the provision allowing guns in schools (even Scott opposes that).

But many people on both sides of the gun issue issue favor the proposed legislation’s mental health portion, whichwould provide nearly $90 million more for mental health resources, including $69 million for schools.

Right now, there is roughly one school psychologist for every 2,000 students in Florida. The National Association of School Psychologists suggests there should be four times as many.

Dr. Mark Cavitt is a psychiatrist at All Children’s Hospital in St. Petersburg. The renewed interest and funding is a good start, he says, but “it alone is not going to prevent the next episode of mass violence.”

Though lawmakers stress that early detection of mental illness is key to keeping another school shooting from happening, Cavitt says there are other contributing factors, such as drug and alcohol use and gun availability. More research is needed, he says, to tease out the true mix of causes.

Brown-Woofter says she does think legislators are directing some money in the right place in this budget: funding to put more counselors in schools and to offer more training to help school employees to identify mental illness.

“We are really pleased to see the attention and the awareness of mental health services now in the budget,” she says.

Survivors of the shootings also may need ongoing treatment, she says, and more counselors in schools could help students and parents get through situations like this — including families and schools that weren’t directly affected.

Fifteen-year-old Hayes DuJardin worries that the same thing could happen at his school in Lakewood Ranch, south of Tampa.

“Parkland versus my school — they are very similar in the way they are set up,” he says, “so everyone was asking, ‘How are we preventing this from happening here?’ “

In the days after the shooting, officials across Florida chased down dozens of threats. Hayes was so disturbed by one online threat he came across that he brought it to his mom, Michelle DuJardin. It had a picture of a teen holding a gun with the words “Get ready for round two, Florida.”

“It’s terrifying when an incident like this happens,” Hayes’ mother says. “You can’t help but be angry — scared.”

The legislation has been passed by Florida’s Senate and is under consideration in the state’s House of Representatives. If approved there, it will head to the governor’s desk. The legislative session ends Friday.

This story is part of NPR’s reporting partnership with Health News Florida and Kaiser Health News.

Let’s block ads! (Why?)

When Landon Morris was diagnosed with hemophilia shortly after birth, his mother, Jessica Morris, was devastated. “It was like having your dreams — all the dreams you imagined for your child — just kind of disappear,” she recalled.

Hemophilia, a rare bleeding disorder caused by a gene mutation that prevents blood from clotting properly, is typically passed from mother to son. Morris’ grandfather had it, and she remembered hearing how painful it was. “It was almost like he was bubble-wrapped,” she said. “He was coddled, because his mom didn’t want him to get hurt.”

But Landon’s life turned out to be much different than she expected.

“He’s wild. He’s probably sometimes the roughest of them all,” she said, as she watched the 6-year-old race around a park in Yuba City, Calif., where the family lives. “He leads a totally normal life. He plays T-ball. He’ll start soccer in the fall. He runs and jumps and wrestles with his brothers.”

His active approach to life is made possible by his medication — the kind that wasn’t available in his grandfather’s day. For the Morris family, this type of drug — broadly known as clotting factor — is a miracle, helping Landon’s blood clot normally. And its cost is almost entirely covered by his father’s federal employee health plan.

But for the health care system, such drugs are enormously expensive, among the priciest in the nation. Medications to treat hemophilia cost an average of more than $270,000 annually per patient, according to a 2015 Express Scripts report. If complications arise, that yearly price tag can soar above $1 million. The U.S. hemophilia drug market, which serves about 20,000 patients, is worth $4.6 billion a year, according to the investment research firm AllianceBernstein.

Examining the stubbornly high cost of these medications opens a window into why some prescription drugs the United States — especially those for rare diseases — have stratospheric prices. The short answer: Competition doesn’t do its traditional job of tamping down costs.

Vying For Patients

The market for hemophilia medicines in the United States is flooded with 28 different drugs, with another 21 drugs in development. Blood factor drugs are biological products — in this case, a protein — and there are no cheaper copies, called biosimilars, available. Not only do prices rise steadily as each new product comes on the market, demand is growing — and pushing costs upward — as more and more clotting factor is used to prevent bleeding episodes, not just to treat them.

Yet competition has not brought prices down in the way someone “operating at the level of undergrad Econ 101 would expect,” said Jerry Avorn, a professor at Harvard Medical School who studies prescription drug costs.

The problem is that companies have no incentive to lower prices. Patients generally don’t push back because insurers pay the bulk of the cost. And insurers tend not to object because the market for the drugs — expensive as they are — is small and the patients are especially vulnerable.

For drug companies, Avorn said, “it’s a magical formula: Lifesaving drug, child at risk of bleeding to death — it kind of casts anybody who looks at costs into the role of some evil Scrooge-like person.”

“The insurers don’t want to end up on the front page of the newspaper saying Little Timmy bled to death because his drug wasn’t covered,” he said.

Also, because prices are high across the hemophilia market, no drug company wants to be the one to blink first. “They don’t want to get a price war started and end up at a super low price point,” said Edmund Pezalla, a consultant to pharmaceutical companies and former executive at Aetna.

So, these drugmakers compete not on price but clinical benefits — such as how long the drugs’ effects last — and through intensive marketing. The pool of potential customers is so valuable that companies often vie directly for individual patients.

Manufacturers, as well as specialty pharmacies that sell the drugs, hire patients and parents as recruiters and advisers, hold dinners and holiday parties, offer scholarships to patients and even run summer camps for children with the disease. The Morris family regularly receives such invitations.

Dr. Jonathan Ducore, a pediatric hematologist-oncologist at the UC Davis Hemophilia Treatment Center in Sacramento, said some of his patients are persuaded by drug company presentations to switch medications. “But the real differences between the drugs are limited,” he said.

Ducore tells his patients if he thinks they are being misled by drugmakers about what a product will do. “But even though the tactics may seem a little smarmy, if it’s the patient’s choice, you have to go with it,” said Ducore, who has been Landon’s doctor since the boy was born.

The first clotting factor products, which came onto the market in the mid-1960s, were derived from human blood plasma, with thousands of donations combined to create one batch. This proved disastrous in the 1980s, when donors unwittingly spread HIV into the blood supply. An estimated 4,000 people with hemophilia — about 40 percent of the patient population in the U.S. — died from AIDS as a result.

In the 1990s, manufacturers introduced a product that did not carry the disease risk of plasma-based drugs — made by cloning human clotting proteins in animal cells. Companies charged a premium for this ever-more-popular “recombinant factor.”

Recombinant factor is difficult and delicate to make, said Steve Garger, a development scientist at Bayer, which produces two popular factor products at its Berkeley, Calif., plant — including Landon Morris’ drug, Kogenate.

Inside a concrete building on the campus, kidney cells from baby hamsters are grown in stainless-steel vessels called bioreactors, and the clotting factor they produce is then purified in steel tanks kept in cold rooms. Working at full capacity, this factory produces less than a pound of clotting factor each year — but when diluted with other ingredients, it’s enough to treat thousands of patients in 80 countries.

The investment in manufacturing and marketing is only part of the reason for the high cost of the drugs, said Kevin O’Leary, vice president of pricing and contracting at Bayer. Bayer does not simply add up the costs, slap on a profit margin and come up with the price, O’Leary explained.

Instead, he said, the company begins by talking to insurers, doctors and patients to get a sense of what value its products bring to the market, especially compared to drugs already available. Bayer then sets a price based on both its investment and the product’s perceived worth. In the end, he said, “we’re charging a price that’s competitive with the other factor products on the market.”

Bayer’s annual sales from its hemophilia drugs were 1.66 billion euros in 2016, the equivalent of $2 billion in the U.S.

Pushing Back On Costs

In Europe, hemophilia drugs cost less than half what they cost in the U.S. That’s because payers — usually governments — request bids and pick products based on cost and quality.

Without pushback from insurers in the U.S., “the price of any drug in the U.S. is whatever the market will bear as seen by the manufacturer,” said Avorn of Harvard.

Recently, a few insurance companies have quietly started to push back on costs. Bayer’s O’Leary said several insurers have approached the company and demanded rebates in exchange for offering the drug to their customers. O’Leary would not discuss the details because he said the contracts are confidential.

State Medicaid programs, which provide health insurance to low-income Americans and cover about half of hemophilia patients, already receive significant rebates from hemophilia drug manufacturers.

Michelle Rice, a senior vice president at the National Hemophilia Foundation, said she has been working with several insurers to help them manage costs safely. “We understand the need to control costs, but they can’t impede access to the product a patient needs,” she said.

It is not yet clear whether such efforts will work, let alone spread.

Sitting at a picnic bench at a park, Jessica Morris pages through Landon’s insurance documents. Over the past year, his care cost over $120,000. She wonders sometimes what would happen if they lost their coverage.

“How much would you be willing to pay to have your child lead a normal life?” she said. “I don’t think that there’s anything we wouldn’t pay or sacrifice for him.”

It’s a problem she prays they’ll never have to face.

Kaiser Health Newsis a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundationthat is not affiliated with Kaiser Permanente.

Let’s block ads! (Why?)

A bipartisan group of senators and House members has been working since last summer toward measures to keep prices from rising out of control and undermining the individual market—the market that serves people who don’t get insurance through work or through the government. Members hope to attach a package of fixes to what should be the year’s final temporary spending bill, due late this month.

The lawmakers are up against both a legislative clock and the insurance companies’ timeline. Insurers have until summer to decide if they want to continue to sell policies on the ACA marketplaces, but many start making preliminary decisions as early as April. Without action, insurers say premiums will go up in 2019 due to the uncertainty. Consumers and the government would share those costs.

It is by no means clear whether any package could gain the votes needed in the House and Senate. Most Republicans are loath to be seen “fixing” Obamacare, although opinion polls clearly show they will be blamed for problems with the law going forward.

Pressure to improve the situation is being felt beyond Capitol Hill. Last week five governors (three Democrats, one Republican and one Independent) released a blueprint for a health system overhaul that includes several of the stabilization ideas under consideration in Congress.

Lawmakers in D.C. are looking at two primary fixes, although they could be combined.

Reinsurance

One, pushed by Sens. Susan Collins (R-Maine) and Bill Nelson (D-Fla.), is called reinsurance. This is a fund that would help insurers pay for the sickest patients and would guarantee the insurance companies do not face large losses. The idea is that if insurers don’t have to worry about covering the expenses for their highest-cost patients, they can keep premiums lower for everyone.

The ACA had a temporary reinsurance program from 2014 to 2016. It was intended to help insurers get started in a market where sick people were able to buy their own insurance for the first time. Prior to the law, most insurers did not cover many people with preexisting health conditions. If they did, it was at an extremely high cost.

Since the federal program ended, several states, including Minnesota and Alaska, have adopted, with some success, their own reinsurance programs in an attempt to hold premiums down.

The subsidy fix

The other proposal, negotiated by Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), would guarantee insurers would get money that the Trump administration cut off in October. The senators are advocating reinstating federal reimbursement for so-called cost-sharing reduction subsidies—discounts that the ACA requires insurers to provide to their lower-income enrollees to help reduce their deductibles and other out-of-pocket costs.

Senate Majority Leader Mitch McConnell (R-Ky.) pledged to Collins, in exchange for her vote on the GOP tax plan in December, that he would support bringing both bills to the floor for debate.

That has not happened. Although, in a statement, Collins said she is “continuing to have productive discussions” with Senate and House leaders about both bills.

Meanwhile, a lot has changed, including new questions about whether the fixes would work.

Would the fixes help?

State insurance regulators managed to find a workaround for Trump’s sudden cancellation of the federal cost-sharing payments.

The cancellation made some premiums higher but the subsidies the federal government gave to consumers also increased to cover those higher prices. That’s because most states allowed insurers to offset the loss of these funds by attaching the premium increases to the plans that determine how much in subsidies enrollees get to pay those premiums. The result is that most people who get government help pay the same (or, in some cases, less), while insurers are effectively being paid back.

That means, however, if the cost-sharing reduction payments were reinstated for 2018, as the original legislation called for, insurers would have to give the excess money back to the government.

Analysts agree that would only add to the confusion.

Restoring the federal payments for this year, says Joseph Antos of the conservative American Enterprise Institute, “does not lower premiums this year, so it does absolutely no good to the average person.”

Some advocates have suggested that Congress should guarantee the payments for 2019 and 2020. But Antos says that “also makes no sense because the insurers would then think ‘Are we going to go through this again?’ ” They might raise premiums even further to make up for the uncertainty.

Antos — and many other analysts — agree that instead, restoring or creating a new reinsurance program would likely do more to control premium increases.

Reinsurance “will protect premiums for the people who are actually most subject to them,” says Sherry Glied, a former Obama administration health official now at New York University. She was referring to those in the individual market who do not get government help and have been footing large premium increases for the past several years. That’s because having protection against the largest bills would allow insurers to lower premiums across the board.

Potential partisan roadblocks

Then there are the political considerations.

Many Republicans in Congress have called the cost-sharing reduction payments, in particular, a “bailout” to the insurance industry and are resistant to reinstate the payments.

Instead, they seem more amenable to the idea of reinsurance, because they consider it a type of “high-risk pool,” which they have been pushing for years. House Speaker Paul Ryan said at an event in Wisconsin in January that “I think there might be a bipartisan opportunity there to get risk pools, risk mechanisms.”

But Republicans have made clear they want something in return for what could be considered a “fix” to the health law they despise.

Health and Human Services Secretary Alex Azar was careful to say in a meeting with reporters last week that the Trump administration has no formal position yet on the stabilization efforts. But, he said, “I think it would need to be part of an entire set of reforms there that we would want to see.” That would likely include more flexibility for states to opt out of some of the health law’s coverage requirements.

The delay has made Democrats more demanding, too. The repeal of the ACA’s penalties next year for people who don’t have insurance has changed the situation dramatically, says Sen. Murray.

“As I have made clear, the bipartisan bill I originally agreed on with Chairman Alexander will not make up for this latest round of Republican health care sabotage,” she said in a statement. “In fact, there are changes that now need to be made to our bill to ensure it meets its intended goals of keeping premiums down and stabilizing markets.”

What’s at stake

But while Congress decides if it will take action, insurers are warning that doing nothing will lead to still higher premiums.

Premium rates for a “benchmark” silver plan could rise by 27 percent in 2019, the Blue Cross Blue Shield Association said earlier this month.

Congressional action on reinsurance and cost-sharing, the association predicted, would help push premium rates 17 percent below this year’s levels.

“Health plans are looking for certainty in the market,” said Justine Handelman, senior vice president in the association’s policy arm.

Ideally, Congress would include the funding in measures adopted this month, said Handelman, who spoke with reporters during a briefing at the association’s Washington, D.C., headquarters: “Most plans are filing premium rates by April.”

Kaiser Health Newsis a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

KHN senior correspondent Julie Appleby contributed to this story.

Let’s block ads! (Why?)