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Bus Stop by Bus Stop, Denver-Area Officials Microtarget Vaccine Hesitancy

7 hours 57 min ago

AURORA, Colo. — John Letson had seen too many apocalyptic movies to feel comfortable getting a covid-19 vaccine initially.

“I was completely against it,” the 40-year-old movie buff said, referencing “I Am Legend” and “Children of Men,” in which humanity is in jeopardy, as examples of what could go wrong. “I think an untested thing during a pandemic has later effects that we don’t know yet.”

After discussing with a doctor the various myths that have arisen about the vaccines, his opposition softened. On the way to get pizza in late June, he happened upon a mobile vaccination clinic behind a bus stop on Colfax Avenue in this Denver suburb and got his first dose.

“I was here. They were here,” he explained, as a nurse gave him a shot of the Pfizer-BioNTech vaccine.

The mobile clinic in the East Colfax neighborhood is part of a new push by Denver-area public health officials to find the neighborhoods where vaccinations lag behind state or county averages. Using detailed maps that show vaccines given by ZIP code or census tract, the health departments highlight underperforming areas being masked by a county’s overall vaccination rate. They then partner with community organizations with intimate knowledge of those neighborhoods to determine strategies to address the specific barriers keeping residents from being inoculated.

As the Biden administration seeks to boost the nation’s vaccine rate by going “neighborhood by neighborhood,” in the president’s words, the approach taken on Colfax Avenue could become a model for the rest of the country. According to the National Association of County and City Health Officials, such efforts depend on the accuracy of the data and the willingness of jurisdictions to work together, which can be difficult for some regions to accomplish. The Denver-area effort has managed to use granular data across seven counties to help raise the vaccination rate by an estimated 4 percentage points in one troubled Colfax area in about a month.

“We have to do the dirty work to be with the community and listen to what their actual concerns are,” Nicole Steffens, a program manager with the nonprofit Colorado Health Institute, said in a presentation on the mapping tool. “We can take all the data that we want based on large, mass groups of people on surveys with vaccine hesitancy or why people aren’t getting vaccinations, but that might not actually apply to that very specific location.”

The public health agencies cooperating in the Denver region represent 3 million Coloradans, about 60% of the state’s population. They overlay data from the state vaccine database with the covid caseload, poverty rates and racial demographics to highlight areas of concern.

“We weren’t very surprised to see the areas that lit up,” said Meghan Prentiss, with the Tri-County Health Department, which serves Adams, Arapahoe and Douglas counties east and south of Denver. “They all kind of followed those common trends of other health indicators.”

East Colfax topped the department’s priority list. The neighborhood, which spans the border between Denver and Aurora, is one of the more impoverished in the metro area, with large numbers of immigrants and minorities, many of whom speak neither English nor Spanish.

Two-thirds of the city of Denver’s eligible residents were fully vaccinated by the end of June, compared with just above 30% in the East Colfax neighborhood. In the 80010 and 80011 ZIP codes, which include the Colfax corridor, fewer than half of those ages 30 to 39 were vaccinated, compared with more than 75% in more affluent Washington Park or City Park.

Part of the problem, people in the community told health officials, was transportation.

Initially, the state had set up mass vaccination clinics in the center of Denver. But many East Colfax residents have no car, relying primarily on public transit. It’s about a 50-minute ride one way on the Route 15 bus to the Ball Arena vaccine site. For many, that was too far to venture.

“It looks great on TV to have these mass clinics where people drive through,” said Judy Shlay, an associate director who runs the immunization program for Denver Public Health, which operates the mobile vaccine clinic. “But we have to be more agile and flexible for people who are maybe more hesitant to go downtown, or because they have to take three buses to get there.”

Moreover, people in the East Colfax area often work hourly jobs as independent contractors or gig workers and get no time off to get vaccinated. And if they fall ill after getting vaccinated, they might miss another day’s pay.

So public health officials worked with transit authorities to identify where high-ridership bus lines intersected in the corridor, settling on a location by a Walmart, a Sprouts grocery store and the Little Caesars restaurant where Letson had gone to buy pizza.

On two days in late June, the mobile clinic vaccinated a total of 150 people, most receiving their first shots. Among them was Marley Sosa, 18, whose sister is a nurse who worked at the clinic.

“She made me feel safe about it,” he said. “People are just hesitant because it’s a new vaccine.”

Ira Milhouse, 40, who is homeless, said he got vaccinated so he could receive a $50 grocery gift card provided as an incentive. Stephanie Aguilar, 18, came after clinic staffers walked through the shopping plaza where the van was parked, informing everyone they could get vaccinated that day.

Others inquired about the incentives but walked away unvaccinated.

Janice Robinson, 53, had come to the bus stop, part of her daily routine of “taking a ride” with no particular destination. “I don’t want the vaccine,” she said. “I don’t think I need it. I don’t really go anywhere.”

Desiree Mister, 45, had just finished a shift at Sprouts. She was tired of wearing a mask and wanted to get vaccinated. But she wasn’t sure if she could sell her plasma if she got vaccinated. She decided she’d come back the following week after a plasma draw. (The Food and Drug Administration says people who have received covid vaccines can continue to donate blood or sell plasma without a waiting period, although rules at plasma collection sites can vary.)

Early data, Shlay said, showed that vaccine access was highly correlated with income, and those able to connect digitally had an easier time tracking down shots. It proved much more difficult for East Colfax residents with language barriers.

That meant the vaccine had to come to East Colfax, which has few police or fire stations, libraries or rec centers that could host vaccine clinics. “We couldn’t anchor something in there,” Shlay said. “So we had to use small organizations that maybe aren’t reaching everybody.”

One of those was the Village Exchange Center, a nonprofit just a block off Colfax Avenue. The center offers benefits to immigrants, including a food bank that serves 4,000 people a day. Workers there inserted flyers about the vaccines into the bags of food they distributed and held information sessions.

“We have several pastors that have just said, ‘This is evil, and we’re not going to do it,’” said Amanda Blaurock, the center’s executive director. “And we respect that. We don’t go around decisions that community members have made. We just say, ‘We’re hosting it, and if you want it, we’re trying to make it as accessible as possible.’”

One census tract in the area has a recorded population of 4,389, and as of mid-June, slightly more than 1,300, or about 30%, were fully vaccinated. Health officials would need to get roughly 1,700 more vaccinated to reach their 70% goal. A month later, the rate had climbed to 34%, and health officials expect more dramatic gains in the coming weeks after people receive their second doses.

The initial success has buoyed interest in more transit-based vaccine clinics. Shontel Lewis, who represents the East Colfax area on the Regional Transportation District mass transit agency’s board of directors and spearheaded its involvement, said future clinics might be held at park-and-ride locations and other bus stops in underserved areas.

“The approach is often cookie-cutter. We tend to go with the same strategies, and then, when no one comes, we just throw our hands up,” Lewis said.

If the goal is to get everybody vaccinated, she said, the interventions need to be tailored to specific communities. “Our approach might be different,” she said, “but our goal is the same.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Diabetes Drug’s New Weight Loss Formula Fuels Cost-Benefit Debate

7 hours 57 min ago

The long list of side effects that follow ads for the newer expensive drugs to treat Type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people — especially those with Type 2 diabetes, which is associated with obesity — may desperately want.

So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for Type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit.

One that recently hit the market — winning Food and Drug Administration approval in June — is Novo Nordisk’s Wegovy, a higher-dose version of the company’s injectable diabetes drug, Ozempic.

Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it “is not a weight loss drug.” Now — with a new name — it is. And clinical trials showed using it leads to significant weight loss for many patients.

“People who go on this medication lose more weight than with any drug we’ve seen, ever,” said Dr. Fatima Cody Stanford, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School who was not involved with any of the clinical trials.

But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it.

Wegovy’s monthly wholesale price tag — set at $1,349 — is about 58% more than Ozempic’s, although, the company points out, the drug’s injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight loss treatments are not universally covered by insurance policies.

The arrival of this new class of weight loss drugs — one from Lilly may soon follow — has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.

“The metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, or ERIC, which represents large, self-insured employers. “If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?”

Weight loss treatments have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember Fen-Phen, a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.

New drugs like Wegovy, more effective but also pricier than previous weight loss treatments, will add more fuel to that debate.

Past treatments were shown to prompt weight loss in the range of 5% to 10% of body weight. But many had relatively serious or unpleasant side effects.

Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the main clinical trial that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.

Side effects, generally considered mild, included nausea, diarrhea, vomiting and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.

Weight loss in those taking Wegovy puts it close to the 20% to 25% losses seen with bariatric surgery, said Stanford at Mass General, and well above the 3% to 4% seen with diet and other lifestyle changes alone.

Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Dr. Sean Wharton, an internal medicine specialist and adjunct professor at York University in Toronto who was among the co-authors of the report outlining the results of the first clinical trial on Wegovy.

Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?

Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for “anorexia, weight loss or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now asking federal officials instead to rewrite existing rules.

Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in 2013.

“Employers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.

The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Maryland, woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.

Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.

“I definitely feel the drug was it for me,” said Pannell, who also followed the trial’s guidance on diet and exercise.

The study found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.

After the trial ended, and the covid-19 pandemic hit, Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.

Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations.

He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.

Still, that is more than the $851 monthly wholesale price of Ozempic. But, he points out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.

“There’s more drug in the pen,” Bachner said. “That drives the price up.”

He added: “This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different clinical program,” which required new trials.

Now scientists, employers, physicians and patients will have to decide whether the new drugs are worth it.

Earlier estimates — some commissioned by Novo Nordisk — of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.

Still, those earlier estimates considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy’s cost.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Amid Covid Booster Debate, West Virginia to Check Immunity of Vaccinated Nursing Home Residents

7 hours 57 min ago

West Virginia raced ahead of the country last winter to get people in nursing homes vaccinated against covid-19, but with cases and hospitalizations on the rise again, state officials want to know whether immunity levels are falling for residents who had their shots.

Starting in August, the state plans to begin measuring the levels of disease-fighting antibodies in the blood of vaccinated nursing home residents, which could help indicate whether they need a booster shot. The process will be voluntary and the data will be shared with federal health agencies evaluating the need for boosters.

Some experts question the strategy, particularly since the federal government has not yet authorized the extra shots.

Covid cases in West Virginia and nationally have more than tripled in the past month. Much of that surge is blamed on the delta variant, a highly contagious form of the virus sweeping the country. In June, about 10% of hospitalized covid patients in West Virginia and 12% of covid deaths were among fully vaccinated people, said Dr. Clay Marsh, executive dean for health sciences at West Virginia University and the state’s coronavirus response coordinator. Nationally, about 3% of hospitalizations and 1% of deaths in July have been among people vaccinated for covid.

Still, deaths attributed to covid remain very rare in West Virginia, which is averaging two fatalities a day. Hospitalizations have risen from 65 covid patients on July 1 to 133 as of July 28, according to state data.

“In West Virginia, we were very aggressive in vaccinating our long-term care population, but we now worry and are paying more attention about whether we have sufficient immunity in those fully vaccinated,” said Marsh, often referred to as the state’s coronavirus czar.

The question of the need for a booster has gained much attention lately. On Thursday, Israel announced plans to start providing booster shots this weekend to adults over 60 years old who have received their second shot at least five months earlier. The decision comes a day after the release of a paper by executives at Pfizer, one of the companies producing a vaccine, that shows a slight dip in efficacy against any symptomatic cases of covid four months after immunization is completed. The paper, which has not been peer-reviewed, predicted that a third shot could boost disease-fighting antibodies many times higher than the level achieved from a two-shot regimen.

Pfizer said it plans to seek Food and Drug Administration authorization for a booster shot by mid-August.

Some health experts cautioned that information on antibody levels may not be helpful.

Dr. Michael Wasserman, a California geriatrician and member of the California vaccine advisory committee, said lower antibody levels don’t automatically mean less immunity. “The fact that antibodies are going down is normal and it doesn’t mean that those people are not immune to the virus,” he said.

Antibodies do decrease over time, “but that doesn’t tell us if you’re exposed to covid whether your body will move into gear and produce more. … The question of whether antibodies are a marker of adequate immunity is one we have not answered yet,” Wasserman said.

West Virginia officials say their nursing home antibody testing could help FDA and other regulators evaluate the need for boosters.

“We want to gather this information and, pending what we find, work with Centers for Disease Control and Prevention and the Food and Drug Administration on an appropriate response,” said Marsh. “This is a complicated issue as antibodies are not the only defense against covid.”

An antibody test will be used to measure levels against what was expected after immunization and whether it is a high-enough level to neutralize the delta variant, he said.

The state will also look at breakthrough infections and how many vaccinated people have ended up hospitalized or dead.

The state’s nursing home industry supports the initiative, although officials say they’ve seen no increase in vaccinated covid residents getting sick. “Our goal is to advance knowledge and information that exists about the vaccines,” said Marty Wright, CEO of the West Virginia Health Care Association, which represents nursing homes. He said antibody testing will offer one indicator of how well vaccines are still working.

Dr. David Wohl, professor of medicine and director of the vaccine clinics at the University of North Carolina School of Medicine, pointed out that even if the West Virginia initiative shows antibody levels have dropped, states can’t provide booster shots until the federal government authorizes them. “You do not do a test unless there is something you can do with the information that you get from the test,” he said.

Wohl said he anticipates that booster shots are likely to be needed eventually and that higher-risk populations — such as those who are immunocompromised or those in nursing homes — would likely be first to get them.

Dr. Mark Roberts, professor and former chair of the health policy and management department at the University of Pittsburgh Graduate School of Public Health, said immunity protection is much more complicated than just the level of antibodies. “It looks like protection from the vaccine wanes, but we don’t know exactly how fast, and if protection wanes it may still protect people from getting sick and dying,” he said.

Wasserman said a bigger question is whether officials are seeing more breakthrough infections in nursing homes and whether unvaccinated staff members are to blame.

“I argued strongly against vaccine mandates when the vaccine came out, but I am in favor of them now” for nursing home workers, Wasserman said.

California requires unvaccinated nursing home staffers to be tested regularly, requiring them to wear N95s. West Virginia requires all nursing home employees to get vaccinated or face twice-a-week testing.

In a joint statement in July, the FDA, the CDC and the National Institutes of Health said the government is analyzing laboratory data, clinical trial data and other data — which can include data from specific pharmaceutical companies — as they evaluate the need for booster shots.

“We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.”

In a press call with reporters, state health officials in Maine, Louisiana and Delaware on Thursday said they are paying attention to the booster shot issue and waiting for CDC guidance, but it’s not their top priority.

“Right now our focus is getting folks first doses, not third doses,” said Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention.

“There will be a time for booster shots, but there are still folks who do not have a first dose and that is where our team is focused,” said Shah, also president of the Association of State and Territorial Health Officials.

KHN senior correspondents Jenny Gold and Markian Hawryluk contributed to this story.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

KHN’s ‘What the Health?’: Hot Covid Summer

Thu, 07/29/2021 - 2:05pm

Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts.

Predictions of a “hot vax summer” that would let Americans who had their covid immunizations celebrate the waning of the pandemic are turning out to have been premature. Covid-19’s delta variant is driving up cases in all 50 states, prompting new recommendations for masks and a growing number of vaccine requirements, including one for most federal workers.

Meanwhile, official Washington celebrated the anniversary of the 1990 Americans with Disabilities Act, which sought to guarantee an array of protections, as concerns grow that people with covid aftereffects could dramatically expand the population needing those protections.

This week’s panelists are Julie Rovner of KHN, Mary Ellen McIntire of CQ Roll Call, Anna Edney of Bloomberg News and Rachana Pradhan of KHN.

Among the takeaways from this week’s episode:

  • The new CDC recommendation for vaccinated people in areas with high covid transmission rates to wear face masks inside has brought complaints from conservative groups about mixed messaging and overzealous regulators. Public health officials counter that the change in advice is understandable because the virus is evolving.
  • The covid surge is most pronounced in areas where vaccination rates were low and may suggest a failure of the public health message that the vaccines are protective only if enough people get vaccinated.
  • The federal effort to vaccinate the public is slowly gaining important support from conservatives. Senate Minority Leader Mitch McConnell is financing public service ads in his home state of Kentucky, and Sarah Huckabee Sanders, who served as one of former President Donald Trump’s press secretaries and is now running for governor of Arkansas, wrote an op-ed about the value of the vaccine.
  • President Joe Biden has appeared reluctant to endorse vaccine mandates, partly because Republicans have been so adamant about opposing them. Even his expected announcement calling for federal workers to get a shot will have an option to undergo regular testing instead.
  • Employers, however, are growing impatient and many are mandating that workers be inoculated for covid. It had been assumed that they would wait for the Food and Drug Administration to give final approval to the vaccines, but that is taking longer than many businesses want.
  • The Missouri Supreme Court ruled unanimously that the state must expand Medicaid, something a majority of voters endorsed last year. The Republican-led legislature refused to fund the expansion and the governor had said he would not expand the program until the legislature funds it.
  • Mississippi officials have filed their brief with the Supreme Court seeking support of a state-passed abortion ban, while House Democrats passed spending bills that get rid of long-standing rules prohibiting the use of federal funds for the procedure. Both sides of the debate seem poised to energize voters.

Also this week, Rovner interviews Samantha Young, who reported the latest KHN-NPR “Bill of the Month” feature about an Olympic cycling hopeful with an Olympic-size medical bill following a bike accident. If you have an outrageous medical bill you’d like to send us, you can do that here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: HBO’s “The Weight of Gold,” by Brett Rapkin, Michael Phelps, Peter Carlisle and Michael O’Hara Lynch

Mary Ellen McIntire: The AP’s “‘OK Not to Be OK’: Mental Health Takes Top Role at Olympics,” by Jenna Fryer

Anna Edney: The New York Times’ “Erin Gilmer, Disability Rights Activist, Dies at 38,” by Clay Risen

Rachana Pradhan: The Tennessean’s “Tennessee to Restart Nearly All Vaccine Outreach Paused Amid GOP Pressure, Says Health Commissioner,” by Brett Kelman

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Pfizer Court Fight Could Legalize Medicare Copays and Unleash ‘Gold Rush’ in Sales

Thu, 07/29/2021 - 5:00am

Three years ago, pharma giant Pfizer paid $24 million to settle federal allegations that it was paying kickbacks and inflating sales by reimbursing Medicare patients for out-of-pocket medication costs.

By making prohibitively expensive medicine essentially free for patients, the company induced them to use Pfizer drugs even as the price of one of those medicines, covered by Medicare and Medicaid, soared 44% to $225,000 a year, the Justice Department alleged.

Now Pfizer is suing Uncle Sam to legalize essentially the same practice it was accused of three years ago — a fighting response to a federal crackdown that has resulted in a dozen drug companies being accused of similar practices.

A Pfizer win could cost taxpayers billions of dollars and erase an important control on pharma marketing after decades of regulatory erosion and soaring drug prices, say health policy analysts. A federal judge’s ruling is expected any day.

“If this is legal for Pfizer, Pfizer will not be the only pharmaceutical company to use this, and there will effectively be a gold rush,” government lawyer Jacob Lillywhite said in oral arguments last month.

Pfizer’s legal argument “is aggressive,” said Chris Robertson, a professor of health law at Boston University. “But I think they’ve got such a political tailwind behind them” because of pocketbook pain over prescription medicine — even though it’s caused by pharma manufacturers. Pfizer’s message, “‘We’re just trying to help people afford their drugs,’ is pretty attractive,” he said.

That’s not all that’s working in Pfizer’s favor. Courts and regulations have been moving pharma’s way since the Food and Drug Administration allowed limited TV drug ads in the 1980s. Other companies of all kinds also have gained free speech rights allowing aggressive marketing and political influence that would have been unthinkable decades ago, legal scholars say.

Among other court arguments, Pfizer initially claimed that current regulation violates its speech protections under the First Amendment, essentially saying it should be allowed to communicate freely with third-party charities to direct patient assistance.

“It’s infuriating to realize that, as outlandish as they seem, these types of claims are finding a good deal of traction before many courts,” said Michelle Mello, a professor of law and medicine at Stanford University. “Drug companies are surely aware that the judicial trend has been toward more expansive recognition of commercial speech rights.”

Pfizer’s lawsuit, in the Southern District of New York, seeks a judge’s permission to directly reimburse patient expenses for two of its heart-failure drugs each costing $225,000 a year. An outside administrator would use Pfizer contributions to cover Medicare copays, deductibles and coinsurance for those drugs, which otherwise would cost patients about $13,000 a year.

Letting pharma companies put money directly into patients’ pockets to pay for their own expensive medicines “does induce people to get a specific product” instead of shopping for a cheaper or more effective alternative, said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University. “It’s kind of the definition of a kickback.”

Government rule-makers have warned against such payments since the launch of Medicare’s Part D drug benefit in 2006. Drug companies routinely help privately insured patients with cost sharing through coupons and other means, but private carriers can negotiate the overall price.

Because Congress gave Medicare no control over prescription drug prices, having patients share at least part of the cost is the only economic force guarding against unlimited price hikes and industry profits at taxpayer expense.

At the same time, however, regulators have allowed the industry to help patients with copays by routing money through outside charities — but only as long as the charities are “bona fide, independent” organizations that don’t match drugmaker money with specific drugs.

Several charities have blatantly violated that rule in recent years by colluding with pharma companies to subsidize particular drugs, the Justice Department has alleged. A dozen companies have paid more than $1 billion to settle allegations of kickback violations.

Pfizer set up an internal fund at one of the charities, the Patient Access Network Foundation, to cover patient costs for a heart arrhythmia drug at exactly the same time it was raising the wholesale cost from $220 to $317 for a package of 40 capsules, the Justice Department said. Pfizer referred Medicare patients who needed the drug to the PAN Foundation, the government said.

Under such arrangements, every $1 million channeled through a charity “has the potential to generate up to $21 m[illion] for the sponsor company, funded by the U.S. government,” Andrew Baum, a Citi pharma stock analyst, wrote in 2017.

Pfizer settled the case, saying it was not an admission of wrongdoing but resulted from its “desire to put this legal matter behind us.”

The PAN Foundation and three other charities also made deals to resolve allegations that they functioned as disallowed conduits for patient assistance for multiple pharma companies. One organization, the Virginia-based Caring Voice Coalition, shut down after government scrutiny.

PAN’s settlement did not mention the alleged Pfizer transactions. Those were described in the separate government deal with Pfizer.

The 2019 PAN agreement related to “legacy matters” and “did not involve any of PAN’s current operations or disease funds,” organization CEO Dan Klein said via a spokesperson. “Nonprofit patient assistance programs like PAN are necessary to help people access the critical medications they need to stay healthy.”

But legal troubles have hardly slowed the pharma-funded patient assistance business.

Four penalized nonprofits agreed to stop directing money to specific drugs, but they continue to accept hundreds of millions of dollars in pharma donations to indirectly cover copays and other patient drug costs, organization reports and IRS filings show. HHS regulators allow the practice because the drug companies are not involved in deciding which patients and which drugs are subsidized.

Donations to six pharma-funded patient assistance charities reached $1.8 billion in 2019, only slightly less than the year before, a KHN analysis of their IRS filings shows. That was nearly 50% higher than the amount from five years previously, before the Justice Department started cracking down.

Last year Pfizer donated $39.7 million to PAN and five other charities helping patients with out-of-pocket drug costs, company disclosures show.

If Pfizer’s lawsuit seeking to earmark such donations for its tafamidis heart-failure drugs opens the way for similar practices industrywide, it would drive up Medicare costs through rising prices and numbers of prescriptions, said Gerard Anderson, an economist and health policy professor at Johns Hopkins University’s Bloomberg School of Public Health. Such a program for tafamidis alone would increase Medicare costs by $30 billion, the Health and Human Services Department’s inspector general estimated.

Pharma companies can “learn which patients are using the drug, and they can market [and offer financial assistance] directly to that patient,” Anderson said. “You get a huge return.”

Pfizer argues that its proposal, which the HHS inspector general called “highly suspect” in an advisory opinion before the company filed its lawsuit, is legal and sensible.

“Providing copay assistance to middle-income patients who have been prescribed tafamidis is an efficient and equitable way to lower their out-of-pocket costs,” company spokesperson Steven Danehy said.

But the real affordability problem for patients is that tafamidis is too expensive, federal attorney Lillywhite said in court arguments last month. (HHS’ Office of Inspector General declined to comment.)

Pfizer has “priced itself out of the market,” he said. The company is seeking to “do something that’s unprecedented, to upend decades of settled law and agency guidance” to boost sales of “what is the most expensive cardiovascular drug ever launched in the United States.”

After the oral arguments, Pfizer dropped claims that HHS rules violate its free speech rights. Judge Mary Kay Vyskocil is considering only the company’s contention that a dedicated fund for tafamidis would not violate kickback prohibitions because, among other arguments, it is the doctor who decides to prescribe the drug and create revenue for Pfizer, not the patient getting the financial assistance.

But legal analysts still see the case as part of a broad movement toward deregulation and corporate rights.

A 1970s Supreme Court case, viewed as paving the way for an explosion of drug, lawyer and liquor ads as well as corporate campaign donations, was about speech rights for prescription drug sellers in Virginia. In 2011 the court found that the First Amendment allows data miners to buy and sell prescription records from pharmacies, provided the patients aren’t identified.

A year later, a federal appeals court cited speech protections when it overturned the conviction of a pharma sales rep who had been promoting a drug for uses not approved by the FDA.

Even if Pfizer loses its case, the climate may be ripe for similar challenges by other drugmakers, especially after the appointment of more than 200 federal judges by business-friendly President Donald Trump, legal scholars said.

The federal kickback law doesn’t mention copay assistance charities “and wasn’t designed with these programs in mind,” said Mello, of Stanford. Pfizer’s lawsuit “should be a loud, clanging call to Congress” to explicitly define drug assistance subsidies as illegal kickbacks, she said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


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Categories: National News Content

Olympic Dream Dashed After Bike Crash and Nightmare Medical Bill Over $200K

Thu, 07/29/2021 - 5:00am

It was a race in Pennsylvania that could have sent cyclist Phil Gaimon to the Tokyo Olympics; instead, a serious crash landed the Californian in two hospitals on the East Coast.

Gaimon knows accidents are, unfortunately, part of the sport. He had retired from competitive road cycling three years earlier, but a recruiting call came in spring 2019 from a coach of the USA Cycling track team.

The coach needed speed for a four-man event. At the time, Gaimon was making a name for himself, and money, by mountain racing, and he was setting records.

“It was a dream come true,” said Gaimon, 35. “A chance at a second career in racing.”

But his Olympic dreams were short-lived. In a sprint with a pack of riders at the velodrome track in eastern Pennsylvania, Gaimon sailed over his handlebars after colliding with a fellow racer. Gaimon hit the ground hard. The result: a fractured collarbone, five broken ribs, a partially collapsed lung and a broken scapula — his worst injuries in the 10 years he had raced on pro road teams in the United States and Europe.

An ambulance whisked him to Lehigh Valley Hospital in Allentown, Pennsylvania, which is part of the health system that sponsored the cycling event. Emergency doctors admitted the athlete and he underwent surgery on his collarbone. He needed surgery on his scapula, too, which he said felt “like a collapsed taco.” But that surgery would happen days later, after he was discharged from the Pennsylvania hospital and a friend helped him find a surgeon in New York.

He chronicled the whole ordeal on his social media channels, and soon he was recuperating — painfully, but successfully — back home. And then the bills came.

The Patient: Phil Gaimon, 35, a former professional cyclist, YouTuber and blogger who earns most of his income through sponsorships. He paid about $500 a month for his insurance policy with Health Net through Covered California, the state’s health insurance exchange. He also had a secondary health insurance policy with USA Cycling.

Total Bills: $151,804 from Lehigh Valley Health Network, and $49,526 from the Hospital for Special Surgery. He had additional bills from various physicians. Health Net has paid approximately $27,000 to Lehigh Valley, according to Gaimon. His secondary insurance, USA Cycling, paid $25,000 to the Hospital for Special Surgery and his surgeon there.

Service Providers: Lehigh Valley Hospital-Cedar Crest in Allentown, Pennsylvania, part of the not-for-profit Lehigh Valley Health Network. The Hospital for Special Surgery, an academic medical center, in Manhattan.

Medical Procedure: Surgery for a fractured collarbone at Lehigh Valley Hospital and surgery for a broken scapula at the Hospital for Special Surgery.

What Gives: Gaimon collided with three health system dangers in this physically and financially painful crash: an out-of-state emergency, out-of-network care and gold-plated prices from both hospitals that treated him. Gaimon said he could sell his house and pay these bills, “but I shouldn’t have to. I have insurance.”

His situation is a scenario many patients have encountered when they need emergency care outside of their provider’s network. It’s known in medical jargon as “balance billing.” Hospitals and insurance companies without mutual contracts often don’t agree on the price of services, and the patient is left to pay the difference.

While at least 33 states have enacted laws intended to protect consumers from balance billing, many don’t apply to out-of-state patients, said Maanasa Kona, an assistant research professor at the Center on Health Insurance Reforms at Georgetown University.

For example, in Gaimon’s home state of California, state law protects enrollees of state-licensed health plans from balance billing, but their authority is limited to California doctors and hospitals.

“These state laws depend upon the state having jurisdiction over the providers involved,” Kona said. “So, nothing is going to stop out-of-state providers from sending bills and hounding the patient. It’s a major gap.”

In Gaimon’s case, the validity of the hospital charges was also questionable. Lehigh Valley Health Network is notorious for big markups on care for out-of-network patients, said Dr. Merrit Quarum, chief executive of WellRithms, which scrutinizes medical bills for self-funded employers and other clients nationwide. “There’s no rhyme or reason as to how they’re charging compared to their costs,” Quarum said.

WellRithms reviewed Gaimon’s bills in detail at the request of KHN and determined that a reasonable reimbursement for the care he received would have been $21,000. That’s $6,000 less than what Health Net had already paid.

In an email to KHN, Lehigh Valley Health Network spokesperson Brian Downs called the calculations by WellRithms “flawed,” and said it is not appropriate to use Medicare-based rates to determine medical costs because they “are not reflective of the actual cost incurred by a provider in rendering any specific medical service.” WellRithms didn’t use Medicare rates, however. It looked up the amounts Lehigh told Medicare it costs the health system to perform a wide range of services.

One reason cited by WellRithms for Gaimon’s high bill: Lehigh Valley Hospital charged him $25,915 for a night in the intensive care unit and $29,785 for a night in the burn unit, according to an explanation of benefits sent to Gaimon by Health Net in January 2020. Gaimon understood he was placed in these specialty units because of a lack of space in other parts of the hospital. But Downs, in his statement, said Gaimon needed the burn unit because of his abrasions and the ICU after his collarbone surgery.

Still, the charges are big markups compared with the costs Lehigh reports to Medicare: $13,038.82 for an ICU patient night and $18,036.92 for a burn ICU patient night, according to WellRithms.

“$25,000 a day for a charge for an ICU is absolutely ridiculous,” Quarum said.

Gaimon’s $49,526 bill from the Hospital for Special Surgery posed other patient-billing land mines.

He recalled representatives from the hospital and his insurance plan telling him he would be billed as an out-of-network patient, but they assured him he could file an appeal because of the extenuating circumstances. And he had secondary insurance offered by USA Cycling that would cover $25,000 for the shoulder surgery, which it did, according to billing records.

He expected his primary insurer, Health Net, to pay some of the cost, too.

But in an Oct. 19, 2019, letter, Health Net denied Gaimon’s appeal because he “self-referred” himself to a surgeon in New York. They also described the surgery as “outpatient” even though he spent the night at the hospital. The letter went on to say the Hospital for Special Surgery had categorized the surgery as elective.

Given his level of pain and the fact surgeons at the first hospital didn’t perform the scapula surgery during his stay, he figured there was nothing “elective” about it. “I needed this surgery and no one else could do it,” Gaimon said.

Health Net spokesperson Darrel Ng declined to comment, saying it doesn’t comment on specific member cases, even though Gaimon gave written permission for his case to be discussed.

A reasonable reimbursement for Gaimon’s out-of-network scapula surgery should have been $13,908, according to WellRithms. Historically, the hospital’s average charge for that surgery was nearly $11,000 even though it cost only $3,094 to perform in the year Gaimon had his surgery, WellRithms found in the 2019 annual cost report the hospital submitted to the federal government.

Resolution: Battling these bills became Gaimon’s full-time job as he recovered from surgery. And, almost two years after the crash, he still faces huge bills from both hospitals despite both hospitals having been paid tens of thousands of dollars through Gaimon’s insurance coverage.

After a reporter made inquiries, a representative from the Hospital for Special Surgery called Gaimon, offering to help him apply for financial assistance based on his income.

In a statement, HSS spokesperson Noelle Carnevale said, “We regret Mr. Gaimon’s dispute with his insurance provider’s classification of the surgery as elective.” And she added, “We are optimistic for an easy resolution, and look forward to celebrating his continuing achievements.”

Gaimon spent months calling and writing letters to Health Net to persuade them to cover the emergency room visit and the collarbone surgery. So far, he has been unsuccessful.

Congress last December passed legislation intended to protect patients like Gaimon against unexpected bills from out-of-network providers. Starting next year, when the law takes effect, patients can be charged only up to the amount of their deductible or copayment when receiving emergency care at any hospital.

The Takeaway: The federal protections against unforeseen medical bills for emergency care kick in Jan. 1, 2022. So, if you travel out of state this year, you should be aware that many state-based insurance plans might not cover you fully or at all in another state.

If you’re in possession of a surprise or balance bill for out-of-state emergency care, contact your health insurance plan and make sure representatives understand it was an emergency. Call the hospital and ask about financial assistance or charity care.

And be aware that the new federal law doesn’t cover everything. Should you be taken to the hospital by a ground ambulance service that’s not in your insurance plan’s network, for example, you could still be on the hook for a large bill.

“There will always be some surprises, because the hospital or the doctors are going to find a way to get you uncovered by the law,” said Gerard Anderson, director of the Center for Hospital Finance and Management at Johns Hopkins University Bloomberg School of Public Health. “It’s always a game of whack-a-mole.”

Stephanie O’Neill contributed the audio profile with this report.

Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Covid Renews Interest in Radiation, but Docs Caution Against Pilgrimages to Radon-Filled Mines

Thu, 07/29/2021 - 5:00am

BOULDER, Mont. — Twice a year, Brian Tichenor makes the 1,200-mile drive each way from his home in Kansas to a defunct uranium mine in Montana, where he takes an elevator 85 feet below the surface to sit amid radioactive radon gas to ease the pain from his chronic eye condition.

“I found it like I think a lot of people do,” said Tichenor, 67. “It’s a point of desperation with conventional treatment.”

While radon is commonly known as a hazardous gas removed from basements, people in pain travel to Montana and pay to breathe, drink and bathe in its radioactive particles. The travelers view the radon exposure as low-dose radiation therapy for a long list of health issues. But the Environmental Protection Agency and the World Health Organization, among others, blame the gas as the second-leading cause of lung cancer. Although cancer doctors use radiation as a front-line treatment to destroy dangerous cells, its role in the U.S. in low doses for other ailments is disputed. The pandemic has recharged that debate as clinical trials across the world test whether low doses of radiation can help treat covid-19 patients.

But radon gas isn’t the same radiation U.S. doctors use, radiation experts caution. Radon is just one of the radioactive chemical elements and, because it’s a gas, it can be inhaled, making it particularly dangerous. Sitting in a radon-filled room and targeted radiation treatment in a medical facility are as different as “chalk and cheese,” said Brian Marples, a professor of radiation oncology at the University of Rochester.

“In clinical therapy, we know exactly what the dose is, we know exactly where it’s going,” he said.

Marples said much of the argument for radon’s therapeutic use relies on historical reports, unlike evidence-based research on clinical radiation. Still, some radiation experts are split on what level of radon should be deemed dangerous and whether it could have positive health effects.

Another concern: The radon treatment in the mines is largely unregulated. The Montana Department of Public Health and Human Services doesn’t have the authority to permit or license the mines, though department spokesperson Jon Ebelt said the adverse health risk from exposure is well known. The EPA also doesn’t have the power to mandate limits on radon.

Nonetheless, each year travelers head to western Montana, where four inactive mines flush with radon are within 11 miles of one another near the rural communities of Basin and Boulder. Day passes range from $7 to $15. The gas naturally forms when radioactive elements in the mountains’ bedrock decay.

Outside the Merry Widow Health Mine, a billboard-like banner announces “Fountain of Youth. FEEL YOUNG AGAIN!” Inside its tunnels, water seeps from the rock walls. Those who want full immersion can slip into a clawfoot tub filled with radon-tainted water. People soak their feet and hands in water or simply sit and work on a puzzle. On a bench sits a printout of a Forbes article on clinical trials that show low-dose radiation could be a treatment for covid-19.

To owner Chang Kim, 69, his business is a mission, especially for those with chronic medical conditions such as arthritis or diabetes. Those who swear by radon therapy say that, in low doses, a little stress on the body triggers the immune system to readapt and reduces inflammation.

“The people coming to the mines, they’re not stupid,” Kim said. “People’s lives are made better by them.”

He learned about the mines 14 years ago when he and his wife, Veronica Kim, lived in Seattle and a connective tissue disease crumpled Veronica’s hands and feet. Traditional medicine wasn’t working. After two sessions a year in the mines ever since, Veronica smiles when she shows her hands.

“They’re not deformed anymore,” she said, adding she’s been able to cut down on her use of meloxicam, a medication to reduce pain and swelling.

Tichenor said going to a mine with radon over six years has been one of the few things to calm his scleritis, a disorder that causes pain he describes as ice picks stabbing his eyes. As for its potential danger, he said radon treatment is just like any medication: Too much can cause harm.

He and other radon users point to European countries such as Germany, where the therapy may be controversial but doctors still can prescribe radon treatments for various conditions that insurance may even cover.

In the U.S., the EPA maintains that no level of radon exposure is risk-free even though everyone encounters the element in their lives. The agency notes radon is responsible for about 21,000 lung cancer deaths every year. It recommends that homeowners with radon levels of 4 picocuries per liter or more should add a radon-reduction system. By contrast, the owners of Montana’s oldest radon therapy mine, Free Enterprise Radon Health Mine, said their mine averages around 1,700.

Monique Mandali said the federal guidelines are “a bunch of baloney.” Mandali lives in Helena, about 40 minutes from the mines, and tries to fit in three sessions at Free Enterprise a year — 25 hours of exposure spread out over 10 days for arthritis in her back.

“People say, ‘Well, you know, but you could get lung cancer.’ And I respond, ‘I’m 74. Who cares at this point?’” she said. “I’d rather take my chances with radon in terms of living with arthritis than with other Western medication.”

Antone Brooks, formerly a U.S. Department of Energy scientist who studied low-dose radiation, is among those who believe the federal government’s no-level-of-radon-exposure stance goes too far. He pointed to research that indicates low doses of radiation potentially turn on pathways within bodies that could be protective. Though what’s considered a “low dose” depends on who’s talking.

“If you want to go into a radon mine twice a year, I’d say, OK, that’s not too much,” he said. “If you want to live down there, I’d say that’s too much.”

In the early 1900s, before antibiotics were popularized, small doses of radiation were used to treat pneumonia with reports it relieved respiratory symptoms. Since then, fear has largely kept the therapeutic potential of low-dose radiation untapped, said Dr. Mohammad Khan, an associate professor with the Winship Cancer Institute at Emory University. But amid the pandemic, health care providers struggling to find treatments as hospital patients lie dying have been giving clinical radiation another look.

So far, the trials Khan has led show that patients who received targeted low-dose radiation to their lungs got off oxygen and out of the hospital sooner than those without the treatment. Khan said more research is necessary, but it could eventually expand clinical radiation’s role for other illnesses.

“Some people think all radiation is the same thing, that all radiation is like the Hiroshima, Nagasaki bombs, but that’s clearly not the case,” Khan said. “If you put radiation in the hands of the experts and the right people — we use it wisely, we use it carefully — that balances risk and benefits.”

The logo for Free Enterprise Radon Health Mine is a miner skipping with crutches in the air. Roughly 70 years ago, a woman said her bursitis disappeared after visiting the mine several times. Thousands of others followed suit.

“We believe in it,” said Leah Lewis, who co-owns the mine with her husband, Ryan Lewis, and has relied on it to help treat her Crohn’s disease.

The couple live on-site and grew up in Boulder, going into the tunnels just as their 5-year-old daughter does now. Her husband’s great-grandfather owned the mine, and the business has been in the family ever since.

“Not one person has come back and said they’ve gotten lung cancer here,” Ryan Lewis said. “If they did, they would shut us down so fast.”

Aside from a billboard outside Helena, the family doesn’t really advertise the business. Clients tend to find them. Like many companies, Ryan Lewis said, Free Enterprise took a hit last year as people canceled plans because of the pandemic. Before that, he said, the business broke about even, adding that radon can be “a hard sell.”

But he said the family of cattle ranchers plans to keep it running as long as it doesn’t cost them money.

“The land is an investment, and we want to keep it in the family,” he said. “And there are a lot of people who use this, and there’s some responsibility there.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Unraveling the Mysterious Mutations That Make Delta the Most Transmissible Covid Virus Yet

Wed, 07/28/2021 - 9:21am

Upon first inspection, the mutations in the highly contagious delta covid variant don’t look that worrisome.

For starters, delta has fewer genetic changes than earlier versions of the coronavirus.

“When people saw that the epidemic in India was driven by delta, they did not suspect it would be so bad or overtake other variants,” said Trevor Bedford, an evolutionary biologist at the Fred Hutchinson Cancer Research Center.

But those expectations were wrong.

Delta has kept some of the most successful mutations found in earlier variants, but also contains new genetic changes that enable it to spread twice as fast.

Delta is more dangerous in many ways. It has an incubation period of four days, rather than six, making people contagious sooner. When the pandemic began, people spread the original coronavirus to an average of two or three people. Today, people infected with delta infect six people, on average.

As of this week, the delta variant had caused at least 92% of the new infections in the United States, according to, a research firm in Bern, Switzerland.

Although delta isn’t necessarily any more lethal than other variants, it can kill huge numbers of people simply because it infects so many more, said Dr. Eric Topol, founder and director of the Scripps Research Translational Institute.

Scientists have sequenced delta’s mutations but are still trying to understand their significance, said Angela Rasmussen, a virologist at the University of Saskatchewan’s Vaccine and Infectious Disease Organization. “When we see the same mutations appearing repeatedly and independently, that suggests they’re important,” Rasmussen said.

Scientists have the best understanding of mutations on the so-called spike protein — which sticks out from the surface of the virus like a club — and which have been studied the most intensely because of its serious ramifications, Rasmussen said. The coronavirus uses the spike protein to enter human cells, and changes in the spike can help the virus evade antibodies.

Scientists believe one of the most important areas of the spike is the receptor-binding domain, the specific part of the protein that allows the virus to latch onto a receptor on the surface of our cells, said Vaughn Cooper, a professor of microbiology and molecular genetics at the University of Pittsburgh. Receptors are like sockets or docking stations that allow proteins to interact with the cell. Once the virus gains entry to the cell, it can cause havoc, hijacking the cell’s genetic machinery and turning it into a virus-making factory.

Delta’s Worrisome Mix

Delta’s rapid spread is particularly surprising given it lacks two mutations that made earlier variants so scary.

Delta doesn’t have the N501Y spike mutation found in the alpha, beta and gamma variants, which enabled them to invade cells more successfully than the original virus. That mutation changed one amino acid — a building block of proteins — in the receptor-binding domain.

Delta also lacks the E484K mutation, which has made the gamma variant so worrisome. This genetic change, sometimes called “Eek,” allows the virus to spread even among vaccinated people.

(Scientists use the Greek alphabet to name variants of concern.)

“The ‘D’ in delta stands for ‘different’ and a ‘detour’ to a different genomic mutation path,” Topol said. “But it doesn’t mean ‘doom,’” he said, noting that existing covid vaccines remain mostly effective against the delta variant.

Vaccines protect people from covid by providing them with antibodies that attach themselves to the spike protein, preventing the virus from entering cells. By dramatically reducing the number of viruses that enter cells, vaccines can prevent people from developing severe disease and make them less infectious to others.

Delta does share mutations with other successful variants. Like all the identified variants in circulation, delta contains a spike mutation called D614G, sometimes known as “Doug,” which became ubiquitous last year.

Scientists think Doug increases the density of spike protein on the surface of viral particles and makes it easier for the virus to enter cells.

Delta also has a spike mutation called P681R, which closely resembles a mutation in the alpha variant that appears to produce higher viral loads in patients, Cooper said. People infected with delta have 1,000 times more virus in their respiratory tract, making them more likely to spread the virus when they sneeze, cough or talk.

The P681R mutation, also found in the kappa variant, is located at the beginning of a part of the genome called the furin cleavage site, Cooper said.

Furin is a naturally occurring human enzyme that gets hijacked by the coronavirus, which uses it to slice the spike protein into the optimal shape for entering the cell, Rasmussen said. The new mutation makes that sculpting more efficient, Rasmussen said.

Another delta mutation — also found in kappa and epsilon — is called L452R. Experiments suggest this mutation, which also affects the receptor-binding domain, acts to prevent antibodies from neutralizing the virus, Cooper said.

These mutations appear to be more formidable as a team than alone.

The genetic changes “are certainly doing something, but why that combination makes the delta variant more fit is not entirely obvious,” Bedford said. “Putting them together seems to matter.”

Delta also has developed genetic changes not seen in other variants.

One such spike mutation is called D950N. “This might be unique,” Cooper said. “We don’t see that anywhere else.”

The D950N mutation is different than other mutations because it’s located outside the receptor-binding domain in an area of the coronavirus genome that helps the virus fuse with human cells, Cooper said. Fusing with human cells allows the coronavirus to dump its genetic material into those cells.

This mutation could affect which types of cells the virus infects, potentially allowing it to harm different organs and tissues. Mutations in this region are also associated with higher viral loads, Cooper said.

Delta also contains mutations in a part of the spike protein called the N-terminal domain, which provides a “supersite” for antibodies to latch onto the virus and prevent it from entering cells, said Dr. Hana Akselrod, an infectious diseases specialist at the George Washington University School of Medicine & Health Sciences.

Mutations in this region make monoclonal antibodies less effective in treating covid and increases the delta variant’s ability to escape vaccine-generated antibodies, Akselrod said. That may explain why vaccinated people are slightly more likely to become infected with delta, causing mostly mild illness but allowing them to transmit the virus.

Delta’s Future Course

Scientists say it’s impossible to predict exactly how delta will behave in the future, although Topol said, “It’s going to get worse.”

Topol noted that delta outbreaks tend to last 10 to 12 weeks, as the virus “burns through” susceptible populations.

If the United States continues to follow a pattern seen in the United Kingdom and the Netherlands, infections could rise from the current seven-day moving average of 42,000 cases to 250,000 a day. Yet Topol said the United States is unlikely to suffer the high death rates seen in India, Tunisia and Indonesia because nearly half the population here is fully vaccinated.

While some studies have concluded that the Johnson & Johnson vaccine stimulates strong and persistent antibodies against delta, a new report found that antibodies elicited by one shot may not be enough to neutralize delta. Authors of that study, from the New York University Grossman School of Medicine, suggested a second dose may be needed.

Two doses of the Pfizer-BioNTech vaccine protect 94% of people from any symptomatic infection by the alpha variant, compared with 88% against the delta variant, according to a new study in the New England Journal of Medicine. Two doses of the AstraZeneca vaccine protect 75% of people from alpha and 67% from delta.

Cooper said covid vaccines offer remarkably good protection. “I will always celebrate these vaccines as the scientific achievements of my lifetime,” he said.

The best way to slow down the evolution of variants is to share vaccines with the world, vaccinating as many people as possible, Bedford said. Because viruses undergo genetic changes only when they spread from one host to another, stopping transmission denies them a chance to mutate.

Whether the coronavirus evolves more deadly variants “is totally in our hands,” Cooper said. “If the number of infections remains high, it’s going to continue to evolve.”

By failing to contain the virus through vaccination, wearing masks and avoiding crowds, people are allowing the coronavirus to morph into increasingly dangerous forms, said Dr. William Haseltine, a former Harvard Medical School professor who helped design treatments for HIV/AIDS.

“It’s getting better, and we’re making it better,” he said. “Having half the population vaccinated and half unvaccinated and unprotected — that is the exact experiment I would design if I were a devil and trying to design a vaccine-busting virus.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Las misteriosas mutaciones que hacen de delta la variante del virus de covid más contagiosa hasta ahora

Wed, 07/28/2021 - 9:16am

A primera vista, las mutaciones de la variante delta de covid, altamente contagiosa, no parecen tan preocupantes.

Para empezar, delta tiene menos cambios genéticos que las versiones anteriores del coronavirus.

“Cuando se supo que la epidemia en la India estaba impulsada por delta, nadie imaginó que sería tan mala o que superaría a otras variantes”, dijo Trevor Bedford, biólogo del Centro Fred Hutchinson para la Investigación del Cáncer.

Se equivocaron.

Delta ha mantenido algunas de las mutaciones más exitosas encontradas en variantes anteriores, pero también contiene nuevos cambios genéticos que le permiten propagarse dos veces más rápido.

Delta es más peligrosa en muchos aspectos. Tiene un período de incubación de cuatro días, en lugar de seis, lo que hace que la gente se contagie antes. Cuando comenzó la pandemia, las personas contagiaban el coronavirus original a un promedio de dos o tres personas. Hoy, los infectados por delta contagian, en promedio, a seis.

Hasta hoy, la variante delta había causado al menos el 92% de las nuevas infecciones en los Estados Unidos, según, una empresa de investigación en Berna, Suiza.

Aunque la variante delta no es necesariamente más letal que otras, puede matar a un gran número de personas simplemente porque infecta a muchas más, señaló el doctor Eric Topol, fundador y director del Scripps Research Translational Institute.

Los científicos han secuenciado las mutaciones de delta, pero todavía están tratando de entender su relevancia, afirmó Angela Rasmussen, viróloga de la Organización de Vacunas y Enfermedades Infecciosas de la Universidad de Saskatchewan. “Cuando vemos que las mismas mutaciones aparecen de forma repetida e independiente, eso sugiere que son importantes”, dijo Rasmussen.

Los científicos son los que mejor conocen las mutaciones de la llamada proteína pico (o espiga), que sobresale de la superficie del virus como un garrote, y que se han estudiado con mayor intensidad por sus graves ramificaciones, explicó Rasmussen. El coronavirus utiliza la proteína pico para entrar en las células humanas, y sus cambios pueden ayudar al virus a evadir los anticuerpos.

Los científicos creen que una de las zonas más importantes de este pico es la región de unión al receptor (RBD), la parte específica de la proteína que permite al virus engancharse a un receptor en la superficie de nuestras células, dijo Vaughn Cooper, profesor de microbiología y genética molecular de la Universidad de Pittsburgh.

Los receptores son como enchufes o estaciones de acoplamiento que permiten a las proteínas interactuar con la célula. Una vez que el virus consigue entrar en la célula puede causar estragos, secuestrando la maquinaria genética y convirtiéndola en una fábrica de virus.

La preocupante mezcla de delta

La rápida propagación de delta resulta sorprendente, ya que carece de las dos mutaciones que volvieron tan temibles a las variantes anteriores.

Delta no tiene la mutación N501Y que se encuentra en las variantes alfa, beta y gamma, que les permitía invadir las células con más éxito que el virus original. Esa mutación cambió un aminoácido —un bloque de construcción de proteínas— en el RBD, el receptor del virus que lo ayuda a penetrar la célula.

Delta también carece de la mutación E484K, que ha hecho que la variante gamma sea tan preocupante. Este cambio genético, a veces llamado “Eek”, permite que el virus se propague incluso entre personas vacunadas.

(Los científicos utilizan el alfabeto griego para nombrar las variantes que más preocupan).

“La ‘D’ de delta significa ‘diferente’ y un ‘desvío’ hacia una ruta de mutación genómica distinta”, indicó Topol. “Pero no significa ‘destrucción'”, agregó, señalando que las vacunas existentes contra covid siguen siendo eficaces contra la variante delta.

Las vacunas protegen a las personas de covid, proporcionándoles anticuerpos que se adhieren a la proteína pico, impidiendo que el virus entre en las células. Al reducir drásticamente el número de virus que entran en las células, las vacunas pueden evitar que las personas desarrollen una enfermedad grave, y también hace que sean menos infecciosas para los demás.

Delta comparte mutaciones con otras variantes exitosas. Al igual que todas las cepas identificadas, delta contiene una mutación pico llamada D614G, a veces conocida como “Doug”, que se volvió omnipresente el año pasado.

Los científicos creen que Doug aumenta la densidad de la proteína pico en la superficie de las partículas víricas y facilita la entrada del virus en las células.

Delta también tiene una mutación espiga llamada P681R, que se parece mucho a una mutación de la variante alfa que produciría cargas virales más altas en los pacientes, según Cooper. Las personas infectadas con delta tienen 1,000 veces más virus en sus vías respiratorias, lo que las hace más propensas a propagar el virus cuando estornudan, tosen o hablan.

La mutación P681R, que también se encuentra en la variante kappa, está situada al inicio de una parte del genoma llamada sitio de escisión de la furina, explicó Cooper.

La furina es una enzima humana natural a la que el coronavirus secuestra: la usa para cortar la proteína pico en una forma óptima para entrar en la célula, dijo Rasmussen, apuntando que la nueva mutación hace que esa obra sea más eficiente.

Otra mutación delta, que también se encuentra en kappa y épsilon, se llama L452R. Los experimentos sugieren que esta mutación, que también afecta al RBD, actúa impidiendo que los anticuerpos neutralicen el virus, explicó Cooper.

Estas mutaciones parecen ser más formidables en equipo que por separado.

Los cambios genéticos “ciertamente hacen algo, pero no es del todo evidente por qué esa combinación hace que la variante delta sea más apta”, dijo Bedford. “Que se junten parece ser la clave”.

Delta también ha desarrollado cambios genéticos que no se ven en otras variantes.

Una de esas mutaciones pico es D950N. “Esto puede ser diferente”, apuntó Cooper. “No lo vemos en ningún otro sitio”.

Cooper explicó que la mutación D950N es diferente porque está situada fuera de la región de unión al receptor (RBD), en una zona del genoma del coronavirus que lo ayuda a fusionarse con las células humanas. Esta fusión permite al coronavirus verter su material genético en esas células.

Esta mutación podría afectar a los tipos de células que infecta el virus, lo que le permitiría dañar diferentes órganos y tejidos. Las mutaciones en esta región también se asocian a una mayor carga viral, dijo Cooper.

Delta también contiene mutaciones en una parte de la proteína espiga denominada dominio N-terminal, que proporciona un “supersitio” para que los anticuerpos se adhieran al virus e impidan su entrada en las células, apuntó la doctora Hana Akselrod, especialista en enfermedades infecciosas de la Escuela de Medicina y Ciencias de la Salud de la Universidad George Washington.

Las mutaciones en esta región hacen que los anticuerpos monoclonales sean menos eficaces en el tratamiento de covid, y aumentan la capacidad de la variante delta para escapar de los anticuerpos generados por la vacuna, señaló Akselrod. Esto podría explicar por qué las personas vacunadas son ligeramente más propensas a infectarse con delta, lo que les causa una enfermedad leve, pero les permite contagiar el virus.

El comportamiento futuro de delta

Los científicos dicen que es imposible predecir exactamente cómo se comportará delta en el futuro, aunque Topol aseguró: “Va a empeorar”.

Topol señaló que los brotes de delta suelen durar entre 10 y 12 semanas, ya que el virus “arrasa” entre las poblaciones susceptibles.

Si Estados Unidos sigue el patrón observado en el Reino Unido y los Países Bajos, los contagios podrían pasar del actual promedio móvil de siete días de 42,000 casos a 250,000 al día. Sin embargo, Topol indicó que es poco probable que Estados Unidos sufra las elevadas tasas de mortalidad observadas en India, Túnez e Indonesia porque casi la mitad de la población está totalmente vacunada.

Mientras algunos estudios han concluido que la vacuna de Johnson & Johnson estimula anticuerpos fuertes y persistentes contra delta, un nuevo informe encontró que los anticuerpos provocados por una sola inyección pueden no ser suficientes para neutralizarla. Los autores de ese estudio, de la Escuela de Medicina Grossman de la Universidad de Nueva York, sugirieron que podría ser necesaria una segunda dosis.

Dos dosis de la vacuna de Pfizer-BioNTech protegen al 94% de las personas de cualquier infección sintomática por la variante alfa, en comparación con el 88% contra la variante delta, según un nuevo estudio publicado en el New England Journal of Medicine. Dos dosis de la vacuna de AstraZeneca protegen al 75% de las personas de la variante alfa y al 67% de delta.

Cooper dijo que las vacunas contra covid ofrecen una protección notable. “Siempre celebraré estas vacunas como uno de los logros científicos de mi tiempo”, remarcó.

La mejor manera de frenar la evolución de las variantes es compartir las vacunas con el mundo, vacunando al mayor número de personas posible, enfatizó Bedford. Como los virus sólo sufren cambios genéticos cuando se propagan de un huésped a otro, detener la transmisión les niega la oportunidad de mutar.

Que el coronavirus desarrolle variantes más mortíferas “está totalmente en nuestras manos”, afirmó Cooper. “Si el número de infecciones sigue siendo alto, va a seguir evolucionando”.

Al no contener el virus mediante la vacunación, el uso de mascarillas y evitando las multitudes, se está permitiendo que el coronavirus se transforme en formas cada vez más peligrosas, advirtió el doctor William Haseltine, ex profesor de la Escuela de Medicina de Harvard que ayudó a diseñar tratamientos para el VIH/SIDA.

“Está mejorando, y lo estamos haciendo mejor”, dijo. “Tener a la mitad de la población vacunada y a la otra mitad sin vacunar y desprotegida: ése es el experimento que yo haría si fuera un demonio y tratara de diseñar un virus destructor de vacunas”.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Women Say California Insurer Makes It Too Hard to Get Drug for Postpartum Depression

Wed, 07/28/2021 - 5:00am

When Miriam McDonald decided she wanted to have another baby at age 44, her doctor told her she had a better chance of winning the lottery. So when she got pregnant right away, she and her husband were thrilled. But within three days of giving birth to their son, in September 2019, everything shifted.

“I was thinking, ‘Oh my God, what did I do?’ I just brought this baby into this world and I can barely take care of myself right now,” she recalled. “I feel exhausted. I haven’t slept in three days. I haven’t really eaten in three days.”

As the weeks went by, her depression got worse. She felt sad, but also indifferent. She didn’t want to hold her baby, she didn’t want to change him. She says she felt no connection with him.

This confused her — she never felt anything like this after her first two kids — and she worried her mood might hurt her son. Untreated postpartum depression can affect babies’ cognitive and social development. For the mother, it can be life or death. Suicide accounts for up to 20% of maternal deaths.

“Every day, I was crying. Every day, I felt like I just wanted to die. Every day, I thought about ending my life,” said McDonald, who lives in Vacaville, California, and works as an IT professional at the University of California-Davis.

She went to Kaiser Permanente, her health care provider, for help. (KHN is not affiliated with Kaiser Permanente.) She said doctors there put her on a merry-go-round of medication trial and error. The first drug her doctor prescribed made her anxious. Upping the dose of a second drug gave her horrific nightmares. A third drug gave her auditory and visual hallucinations that took seven weeks to go away after she stopped taking it.

Then, her psychiatrist retired. And when McDonald complained to her new psychiatrist that she was still depressed, four months after giving birth, the physician suggested more medications.

“I was desperate,” McDonald said. “I was like, ‘I’m trying to help myself, but things are just getting worse. So what am I left with?'”

She did her own research and learned about a new treatment, brexanolone. It’s the first and only drug approved by the Food and Drug Administration specifically to treat postpartum depression, which affects 1 in 8 new mothers in the United States. Instead of targeting the serotonin system in the brain, like many antidepressants, brexanolone replenishes a hormone metabolite that gets depleted after childbirth: allopregnanolone. Some doctors call allopregnanolone, which is produced by progesterone, “nature’s Valium” because it helps regulate neurotransmitters that affect mood. After giving birth, natural levels of estrogen, progesterone and allopregnanolone all plummet rapidly, making some women vulnerable to postpartum depression. Brexanolone is a synthetic version of allopregnanolone, delivered through an IV infusion over the course of 60 hours. It costs $34,000 per treatment.

In clinical trials, 75% of women who got brexanolone started to feel better immediately after the three-day treatment. Half the women went into remission. In the placebo group, 56% of women responded and a quarter went into remission. In practice, doctors are seeing that the effectiveness of the drug in the field mirrors the trial results.

“People walk out of the hospital, wanting to be with their child, wanting to return home,” said Dr. Riah Patterson, who has been treating women with brexanolone at the University of North Carolina-Chapel Hill since it became available in summer 2019. “There is a hopefulness, a brightness. You can really see that transformation in the hospital room over those 60 hours. It’s pretty miraculous.”

McDonald wanted to try it.

But when she asked her doctor for brexanolone, she was told no. In an email, the doctor wrote that the existing studies were “not very impressive.” She added that McDonald did not meet Kaiser Permanente’s criteria for the drug: She would first have to try — and fail to improve with — four medications and electroconvulsive therapy (ECT) before she could try brexanolone. And she had to be six months or less postpartum to try it at all. For Miriam, the clock had run out. She wondered, How could anyone qualify?

“This is crazy. By the time you even try one drug, that’s like four weeks out,” she said, noting that traditional antidepressants take weeks to become effective and weeks to taper off from. “There’s just no way.”

‘Unacceptable Burden’ on New Moms

Kaiser Permanente’s guidance is an outlier. An analysis of guidelines from a dozen health plans revealed that three of them require women to fail treatment with at least one other medication before trying brexanolone. One plan, California’s Medicaid program for low-income women, requires two fails. But KP is the only system analyzed that recommends women first fail four drugs, as well as ECT.

“That’s absurd. So I’m assuming no woman will ever have the opportunity to try brexanolone?” said UNC’s Patterson, one of several experts on postpartum depression who questioned KP’s guidance.

“Asking someone to fail four oral antidepressants is an unacceptable burden that will undoubtedly create more harm than good,” said Bethany Sasaki, who runs the Midtown Birth Center in Sacramento, California, and is licensed to administer brexanolone.

Psychiatrist Dr. Shannon Clark, who’s been administering brexanolone at UC Davis Medical Center for the past two years, seeing positive results, said there are a lot of reasons new moms may not be candidates for one medication, let alone four: taking pills while breastfeeding could be too anxiety-provoking; some women may not be able to adhere to a daily pill regimen; or they may have a liver condition that contraindicates those medications. Clark called Kaiser Permanente’s guidance “terrible.”

It could also be illegal, according to some California lawmakers and mental health advocates. Under a California state law that took effect this January, health plans must conform to generally accepted standards of care, including scientific literature and expert consensus, when making decisions about mental health treatment.

“If Kaiser is making it effectively impossible to get a particular, important mental health treatment, that could definitely be a violation of our parity law,” said state Sen. Scott Wiener (D-San Francisco), the bill’s author.

KP officials responded by saying they always follow the law. They also say its integrated structure — as both the health insurer and the health provider — makes it different from traditional insurers. At KP, a patient’s doctor determines whether a medication is appropriate, not the health plan, and the criteria doctors use are recommendations, not requirements or prerequisites that patients need to “exhaust,” said Dr. Maria Koshy, KP’s chair of psychiatry for Northern California.

“At the end of the day, this is an individual clinical decision by both the provider — the physician — and the patient,” she said.

But inside KP, the workplace culture is such that doctors are expected to follow these recommendations, according to former KP clinicians who spoke on background — as well as legislative experts familiar with KP’s model. They say that when KP doctors deviate from the recommendations, they can get questioned or face other consequences.

“These physicians know that if they start routinely ignoring these bad recommendations, that that could have impacts on them professionally,” said Wiener, who has worked on several bills aimed at regulating KP and other insurers in California. “Whether it’s couched as a recommendation or a requirement is almost irrelevant. It has the same effect.”

To McDonald, her physician seemed to follow the recommended criteria as if they were requirements when she declined to prescribe brexanolone. Another patient, Yesenia Muñoz, got a similar response when she sought brexanolone treatment. KP’s grievance department sent her a letter denying the request because she had not failed enough medications.

“When I talked to the caseworker at Kaiser that had denied the medication, he said that Zulresso was very expensive,” said Muñoz, referring to brexanolone’s brand name.

In addition to the $34,000 cost for brexanolone, the three-day hospital stay can tack on another $30,000 to a patient’s bill. Another complicating factor is the FDA requirement that health centers obtain special certification to infuse brexanolone, because of the risks of excessive sedation or fainting from the drug. KP doesn’t have the certifications yet to administer the treatment at its own hospitals, so it must pay outside hospitals to provide it for its patients. KP officials say they have plans to eventually open three of their own certified centers in Northern California.

Muñoz, 35, was devastated by the denial. She was overwhelmed by postpartum depression and anxiety shortly after her daughter was born in August 2020. But none of the medications or therapies KP offered her worked. Four months after giving birth, she still felt suicidal.

“I could get out the door sometimes and take the stroller and go walk, and my mind kept on saying, ‘If you just step in front of the car, it’s all going to go away,” she remembered.

Muñoz got help from family members and co-workers to appeal KP’s decision to the state, and after reviewing her medical records, regulators ordered KP to pay for the brexanolone treatment.

Muñoz received the treatment at UC Davis Medical Center, and she started feeling better within the first day.

“The nurse came in and she said something funny and I laughed,” Muñoz said. “It was the first time I had laughed in so long.”

She started looking through photos and videos of her daughter on her phone and she said it was like she was experiencing those moments for the first time. She started making plans for the future.

“It was like a switch flicked and it made me happy enough to want to live,” she said. “It saved my life.”

Sage Therapeutics, the maker of brexanolone, said KP’s approach to the new drug reflects “a lack of a sense of urgency for treating mental health.” Dr. Steve Kanes, Sage’s chief medical officer, said the company is working on making the treatment more accessible. Its biggest challenge has been getting enough health centers certified, across a wide enough geography, to reach women who need it. The company is studying a pill form of allopregnanolone that could eliminate the need for a hospital stay, but Kanes said that is still not close to being commercially available.

Stitching Up Legal Loopholes

In 2008, Congress passed a landmark federal law aimed at correcting disparities between how insurers pay for mental health treatments compared with care for physical health. The Mental Health Parity and Addiction Equity Act was later reinforced by provisions in the Affordable Care Act in 2010. But insurers found loopholes, creating overly restrictive or self-serving criteria that made it easy to deny services for mental health care and, as a result, save money.

California’s new law, SB 855, aimed to tighten those loopholes and has been hailed by advocates as a national model for mental health reform. It requires health plans to use clinically based, expert-recognized criteria and guidelines in making medical decisions, with the goal of limiting arbitrary or cost-driven denials for treatments of mental health or substance use disorders.

KP operates in eight states and Washington, D.C. In California, it is the largest insurer, and in 2011 held a 40% share of the market, covering 9.2 million patients. KP officials have questioned how the new state law applies to the Kaiser system, given its unique integrated structure as both health insurer and medical provider. For example, Koshy, the KP psychiatrist, said that SB 855’s requirement to comply with generally accepted standards of care “does not apply” to its brexanolone recommendations because they were developed and are used by the doctors, not the health plan administrators. When a reporter asked KP to provide the brexanolone policy its health plan uses for grievances or appeals, it said it didn’t have one.

“We 100% intended this law to apply to the care people get at Kaiser,” said Julie Snyder, government affairs director at the Steinberg Institute, which co-sponsored the law. “There is no place where we say Kaiser is exempt” because of its integrated structure.

Doctors at Kaiser have historically been “gatekeepers” for services in the system, more so than doctors who work with traditional insurers, said Meiram Bendat, an attorney and licensed psychotherapist who also advised legislators as the law was being drafted. It doesn’t matter if practice recommendations for brexanolone were written by doctors or administrators, or whether the recommendations are mandatory or optional, Bendat said, they must be in compliance with the law.

“If it’s inconsistent with generally accepted standards of care, then it has no place in California,” he said.

Some of KP’s recommended criteria for brexanolone are aligned with generally accepted standards of care; for example, reserving the drug for women who are six months or less postpartum, which was a criterion used in the clinical trials the FDA relied on when approving the drug.

But the recommendation that patients first try four or five alternative depression treatments before considering brexanolone conflicts with the judgment of half a dozen women’s health experts interviewed for this story. They say there just isn’t enough time to do that in the postpartum period — and too much is at stake.

Not only are babies at risk of developmental and emotional problems if their mother is depressed, husbands and partners are also at higher risk for depression and anxiety. And because new moms are learning to breastfeed, and figuring out what’s part of the new normal and what’s not, it can take months just to realize there’s a problem, said UNC’s Patterson.

“It takes so long for this illness to come to recognition and for someone to actually get into an appointment and actually be seen by a provider,” she said.

Despite Run-Around, a Quick Turnaround

Indeed, the FDA fast-tracked the approval of brexanolone, in part, because of how well and how quickly it worked, allowing women to feel better and get back to their families in three days.

“It’s new, it’s promising,” said KP’s Koshy, adding that “it’s not a benign medication.” Six women in the clinical trials felt faint or fainted, which is why the FDA requires women to be continuously monitored in certified health centers when getting the medication.

Also, the safety and efficacy data is limited, Koshy said. The clinical trials compared brexanolone only to placebo, not to alternative treatments. So while the data shows brexanolone works better than nothing, there’s no data on whether it works better than drugs like Zoloft, or better than electroconvulsive therapy.

Women who received the placebo in the trials also showed improvement in depressive symptoms — which is common in studies of depression treatments — but more women who received brexanolone showed improvement, and their improvement was more substantial and lasted longer, especially if their depression was more severe before treatment. Women with moderate depression who received the placebo did just as well, 30 days after treatment, as those who received brexanolone, which could be because they felt better on their own, or because other antidepressants they were allowed to take during the trial finally kicked in.

Koshy said KP is always reviewing practice recommendations as new evidence becomes available, but also acknowledged that KP’s recommendations for brexanolone have not been updated since they were developed two years ago, in July 2019.

Two weeks after this story first aired in Northern California, Koshy said KP is now reviewing the recommendations.

It is unclear what role California’s Department of Managed Health Care, the state agency that regulates KP, might play in resolving issues of access to the infusion. In a statement, department officials said they will review any criteria or guidelines the KP health plan uses for brexanolone, but the department does not have jurisdiction over physician decisions.

The department also monitors patient complaints when new medications or treatments begin to be used, in order to identify problems with access to care. So far, the department has received two complaints about brexanolone — both filed by KP patients.

One was Yesenia Muñoz. The other was Miriam McDonald.

Before going to the state, McDonald called KP’s grievance department to complain about her treatment and the denial of brexanolone. KP responded by sending the cops to her house for a welfare check.

The officers were calm and nice, McDonald said, but when she closed the door, she cried her eyes out.

“It just brought me to a whole new low,” she said. “Why didn’t my doctor call me and talk to me first? I mean, this is how you treat postpartum mental health? How dare you!”

KP declined to comment on any individual cases, but said that, generally, “we feel deep compassion for any patient experiencing the difficult and serious effects of postpartum depression, and our goal is always to support every patient’s safe return to a healthy mental state.”

McDonald never got brexanolone; by the time her appeals were heard, she was past the six-month postpartum window.

Still, she continued to fight for relief and eventually got KP to cover a different treatment for severe depression, transcranial magnetic stimulation, which uses an electromagnetic coil to stimulate nerve cells in the brain that control mood. That typically costs about $300 per session, and McDonald went in for the treatment five days a week, for three months. Now she is finally feeling like herself again.

“I can remember I woke up one day and I was excited. I had actual joy,” she said. “I got up and I walked into his room and I was like, ‘Hey, Nico! Hi! Hey, baby!’ And he jumped up from his crib and giggled and put his arms out. And I just swooped him up in my arms and cried. Because I was like, ‘I am so proud to be your mom.'”

Now when her son smiles at her, she genuinely smiles back. But it took more than 18 months to feel better. She can’t help but grieve all the smiles she didn’t return in that time, and how she felt like she was barely present at crucial times, like when her son took his first steps.

“I felt like I’ve been robbed of all those moments,” she said, “of those little milestones, that I’m never going to get back.”

This story comes from NPR’s health reporting partnership with KQED and Kaiser Health News (KHN).

This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Sign-Up Window for Free COBRA Coverage for Many Laid-Off Workers Closes This Week

Wed, 07/28/2021 - 5:00am

After being laid off from her job as a systems analyst for a specialty chemicals company in December, Gabriela de Pompignan opted to hang on to her former employer’s insurance coverage under the federal law known as COBRA. Typically, laid-off workers pick up the total cost of premiums under COBRA, but her company paid roughly 75% of the expense for the first six months, leaving de Pompignan with a $659 monthly bill for the family plan covering her, her husband and their 9-year-old son.

Since both de Pompignan and her husband, a lawyer, were unemployed, her company’s temporary financial support was crucial to making their premiums affordable. What de Pompignan didn’t realize, however, was that she was eligible for an even better deal. Under the American Rescue Plan Act that President Joe Biden signed in March, COBRA premiums for laid-off workers are covered in full by federal funding for six months from April through September.

Neither her former employer nor the company administering COBRA benefits for her workplace told her about that option.

Under federal rules, she should have been sent a notice by May 31 informing her about the subsidy, which is generally available to people who were involuntarily laid off or whose hours were reduced and who are eligible for continued employer coverage under COBRA.

For people like de Pompignan who lost their jobs before April 1, the window to take advantage of the subsidized coverage is closing. They have 60 days from the date their employer notified them of the COBRA subsidy to sign up for it — that’s July 31 if their employer notified them at the end of May. People notified earlier may have already missed their opportunity.

People can sign up for the subsidy even if they didn’t elect COBRA coverage earlier, or if they had COBRA earlier and dropped it because it was too expensive or for another reason.

Those laid off or furloughed after April 1 have 60 days to sign up for regular COBRA coverage and the temporary financial assistance.

De Pompignan learned about the subsidy only because she happened upon a news story that described it.

“I don’t know their reasons for not communicating this option to us,” said de Pompignan, 45, who lives with her family in Mendham, New Jersey. “But I did feel frustrated.” She added that many workers who have been laid off “could be struggling to get their health insurance paid for during such difficult times.”

In a statement to KHN, Trion Group, the company that administers her former employer’s COBRA coverage, said, “As a COBRA administrator, we rely on our clients to provide us information on which of their former employees are eligible for the ARPA subsidy. Once we were notified of the error in Ms. de Pompignan’s initial status, we immediately made the change in our system and sent her eligibility notification.”

Consumer advocates say they’re worried many more people may have been left in the dark about the subsidy since notices weren’t required to be sent to former workers until the end of May, two months after the benefit started.

“Even if everybody got the notices out on time, are folks reading them and understanding what they’re eligible for and what their options are?” said Katie Keith, an associate research professor at Georgetown University’s Center on Health Insurance Reforms.

Karen Pollitz, a senior fellow at KFF, said she talked with some people who were notified promptly, while others weren’t informed about the subsidy until the very end of May and had to get reimbursed for the first two months of the subsidized premiums. (KHN is an editorially independent program of KFF.)

The Department of Labor said it has “conducted extensive outreach and education to promote awareness of the available premium assistance” to help workers and employers.

The outreach includes virtual webcasts and webinars, social media, radio and TV public service announcements, billboards and posters, according to Labor officials. They added that consumers or employers with questions can contact the department online or by phone.

Under federal COBRA law, people can generally choose to continue their employer health coverage for up to 18 months after being laid off. They usually have 60 days to decide, though that deadline has been extended while the pandemic continues. The law applies to employers with 20 or more employees.

Without the special federal subsidy, however, it’s a pricey benefit: People are usually responsible for the entire premium plus a 2% administrative fee.

People who work at smaller companies — those with fewer than 20 employees — that are located in states that have so-called mini-COBRA coverage continuation laws can also take advantage of the subsidy. But there’s a catch: To qualify, workers generally must already have elected COBRA continuation coverage before April 1 or become eligible after that.

Getting the word out was hampered by the program’s short time frame. It was challenging for employers to figure out who was eligible for the subsidy and get notices out within such a tight timeline, experts said. The law passed in March, and guidance from the Department of Labor and the IRS about implementing the law came in April and May. Notices to workers were due May 31.

“My sense is that employers were working around the clock to make sure the notices went out,” said Katy Johnson, senior counsel for health policy at the American Benefits Council, which represents large employers.

But as de Pompignan’s experience illustrates, some people slipped through the cracks.

With her employer subsidy running out in June, de Pompignan called the service center at Trion Group to find out what her coverage options were. The representative who answered the phone suggested de Pompignan look into marketplace plans.

After de Pompignan saw the news story about the COBRA subsidy, she contacted her former employer to ask if she was eligible. The answer was yes, she likely was. It was only then that she received the paperwork.

De Pompignan, who paid her portion of the COBRA premium for April, May and June, said she’s been assured she’ll be reimbursed.

Because de Pompignan’s job loss was initially incorrectly coded as “voluntary” by her employer, Infineum, “[it] caused the Trion system to exclude her from communications regarding the federal subsidy,” according to Hedy DiSimoni, the human resources benefits and payroll leader at Infineum. De Pompignan will receive a refund for the first three months of premiums she paid before being notified, DiSimoni said.

Once the subsidy ends in September, de Pompignan said, she’s not sure what her family will do if she and her husband are still unemployed.

They could continue their COBRA coverage, paying the full premium. They’ll also have an opportunity to sign up for coverage on the state marketplace, under a special enrollment period.

For some people, marketplace coverage may be a better option.

Anyone who received unemployment insurance benefits for even one week this year can receive a silver-level plan without premiums and with cost-sharing assistance, which could dramatically reduce their out-of-pocket costs, said Sabrina Corlette, a research professor at the Georgetown University Center on Health Insurance Reforms.

“It’ll probably have a lower deductible than a COBRA plan, and it doesn’t turn off after September,” Corlette said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Bye-Bye to Health Insurance ‘Birthday Rule’? Kansas Lawmaker Floats Fix

Tue, 07/27/2021 - 12:00pm

When Kayla Kjelshus gave birth to her first child, the infant spent seven days in the neonatal intensive care unit, known as the NICU. This stressful medical experience was followed by an equally stressful financial one. Because of an obscure health insurance policy called the “birthday rule,” Kjelshus and her husband, Mikkel, were hit with an unexpected charge of more than $200,000 for the NICU stay.

Now, seven months after KHN and NPR published a story about the Kjelshus family’s experience, new parents may be spared this kind of financial uncertainty if lawmakers pass a bill that would give parents more control when it’s time to pick a health insurance policy for their child.

The new proposed law would eliminate the birthday rule. That rule dictates how insurance companies pick the primary insurer for a child when both parents have coverage: The parent whose birthday comes first in the calendar year covers the new baby with their plan first. For the Kjelshuses of Olathe, Kansas, that meant the insurance held by Mikkel, whose birthday is two weeks before his wife’s, was primary, even though his policy was much less generous and based in a different state.

“It’s an outdated policy,” Mikkel Kjelshus said. “Nowadays both parents typically have to work just to make ends meet.” Two jobs often means two offers of health insurance — and while double coverage should be a good thing, in practice, it can lead to a bureaucratic nightmare like the one the Kjelshuses faced.

U.S. Rep. Sharice Davids (D-Kansas) introduced “Empowering Parents’ Healthcare Choices Act,” a bill that would do away with “the birthday rule” and a “coordination of benefits policy” that trips up first-time parents up when it’s time to sign up a new baby for insurance.

“When I heard about the Kjelshus family’s story, I knew there had to be a way to help,” Davids said. “Parents should have the power when it comes to their new baby’s health care coverage.”

For Charlie Kjelshus, the birthday rule meant her dad’s plan — with a $12,000 deductible, a high coinsurance obligation and a network focused in a different state — was deemed her primary coverage. Her mom’s more generous plan was secondary. Confusion over the two plans caused a tangle of red tape for the family that took almost two years and national media attention to resolve.

This model regulation was set by the National Association of Insurance Commissioners and adopted by most states, including Kansas, said Lee Modesitt, director of public affairs with the Kansas Insurance Department.

It is a somewhat arbitrary rule that could be fair if all jobs offered health plans with similar coverage. But for many families, one partner’s plan is much more generous.

“It feels awesome,” Mikkel Kjelshus said of the news that a change has been proposed. “We really didn’t want this to happen to anyone else.”

To be enacted, the bill would need to pass the House and Senate before receiving the president’s signature. Davids was elected to Congress in 2018, flipping a seat in Overland Park, Kansas, that had been held by a Republican for a decade. She was reelected in 2020 and is the only Democrat in Kansas’ House delegation.

Ellie Turner, a spokesperson for the congresswoman, said Davids is talking with colleagues in the House to garner additional support.

“It’s becoming clear that the Kjelshus family is not alone in this experience,” Turner wrote in an email. “We are going to continue working to raise awareness and gain momentum for a birthday rule fix, because every family deserves a choice when it comes to their child’s health.”

As they await the arrival of their second child, this time around the Kjelshus family has a better idea of how the health insurance will work. And, much like the first time, they feel prepared.

“We’ve got the crib. We’ve got the baby stuff. It’s a lot less stress this time around,” Mikkel Kjelshus said. “We kind of know what we’re doing.”

Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Want Fries With That Vaccine? Even at a Fast-Food Restaurant, Pop-Up Clinics See Slow Traffic

Tue, 07/27/2021 - 5:00am

SAN BERNARDINO, Calif. — A few months ago, the boxy, teal truck parked outside a McDonald’s in this Inland Empire city might have drawn hundreds of people willing to stand in line for hours under the scorching sun.

The truck is San Bernardino County’s mobile vaccine unit, which brings covid-19 vaccines directly to people. But on July 15, only 22 people got a covid shot during the four hours it sat there.

Roughly 12 feet away, more people were often seen waiting by a red canopy for free, government-subsidized smartphones, intended for low-income people, than were stepping up for the potentially lifesaving shots.

Barry Luque, a 37-year-old car wash worker who visited the red canopy that day for a free phone, was lured by the truck. He had been eligible for a covid vaccine since April but never got around to making an appointment. Had he not seen the truck in the parking lot on his day off, “this wouldn’t have gotten done,” he said.

It’s Luque’s job to guide drivers into the car wash, but his boss won’t let him take his mask off unless he can show proof he’s vaccinated.

“People come in from different lives, different styles, different moods at different times,” he said after getting his first dose of the Pfizer-BioNTech vaccine. “I’ve got to guide them carefully and gently, and it’s kinda hard for them to see the smile on my face.”

Luque and the other 21 people who got vaccinated that day — in addition to the scores of others who drove by or waited in the McDonald’s drive-thru line without seeking a shot — offer a snapshot of California’s stalling vaccination effort.

Some who finally got the shot, like Luque, were motivated by mandates from employers or are tired of wearing masks. Others want to visit other countries, and vaccinations may help ease travel or quarantine requirements. Some were persuaded, at long last, by family and friends.

Those who continued to hold out primarily cited potential side effects and distrust of the medical system.

Recent polling shows that no matter which tactics are used, a strong majority of unvaccinated people are unlikely to budge on getting a shot, creating an increasingly dangerous scenario as the highly contagious delta variant burns through the country. In California, about 2,800 people were hospitalized for covid or suspected covid — more than twice the number six weeks earlier — as of Wednesday.

About 61% of Californians age 12 and up were fully vaccinated by then, according to the U.S. Centers for Disease Control and Prevention, ranking the state 18th among other states and the District of Columbia.

But the overall rate masks deep disparities among, and even within, regions. In geographically and ethnically diverse San Bernardino County, about 47% of eligible residents were fully vaccinated as of Wednesday, with the lowest rates among young people, men, Latinos, Blacks and those who live in the poorest and unhealthiest communities. Statewide, the profile of unvaccinated people is largely the same.

One way local and state leaders are trying to get shots into residents’ arms is by hosting pop-up clinics that make covid vaccines more convenient and accessible for those who can’t or won’t sign up for an appointment.

San Bernardino County is organizing pop-up events at supermarkets, schools, churches and community centers. The state is also funding vaccine clinics, including 155 events at more than 80 McDonald’s restaurants in 11 counties as of Wednesday.

The pop-ups require significant resources and are showing diminishing returns. About 2,500 doses have been administered at the McDonald’s clinics so far — an average of 16 shots per event. The California Department of Public Health declined to say how much these events cost, saying it varies.

At the McDonald’s in San Bernardino, a city of more than 200,000 that serves as the county seat, eight staffers were on hand to check people in, administer shots and watch for side effects from 9 a.m. to 1 p.m. They also scheduled the necessary second dose for another local pop-up event.

Jeisel Estabillo, 36, hadn’t been vaccinated, even though she is a registered nurse who sometimes cares for covid patients at a hospital. She was one of the first people in the county to become eligible for vaccines, in December, but avoided getting a shot because she wanted to wait and see how it would affect others. She also tested positive for covid during the winter surge.

But Estabillo changed her mind and visited the vaccine clinic with her father and teenage son because they plan to vacation in the Philippines next year and hope vaccination will reduce travel restrictions or quarantines.

Estabillo also likes that vaccinated people can forgo masks in most public places, although that perk may slip away as more California counties respond to the delta surge by calling on residents to mask up again indoors.

But Jasmine Woodson continued to hold out against the vaccine even though she was hired to provide security and direct traffic for the clinic. Woodson, 24, is studying to become a pharmacy technician and has been tracking vaccine news. She said she was alarmed by the brief pause in the administration of the one-shot Johnson & Johnson vaccine over concern about blood clots, and reports of rare heart inflammation linked to the Moderna and Pfizer vaccines. She also knows that no covid vaccine has been fully approved by the Food and Drug Administration, which puts her on high alert.

Woodson, who is Black, is also wary because these mobile vaccine events seem to take place only in low-income Black and Latino neighborhoods — a tactic public health officials say is meant to increase uptake in these communities.

“Every day there’s always something new. You’re not meant to live that long, so if you get it, you get it, and if you don’t, you don’t,” Woodson said of covid.

Maxine Luna, 69, who came to the nearby red canopy to get a phone, also was not swayed. A longtime smoker whose doctor has been pleading with her to get a covid shot, she fears side effects, mentioning a friend who battled two weeks of headaches, diarrhea and vomiting after getting vaccinated.

To mitigate her risk, Luna sticks close to her home, which she shares with her brother, who is vaccinated, and her sister and brother-in-law, who are not.

“We’re not out and about, we don’t go to shows, and we don’t go to crowded places,” she said.

Concern about side effects is the most common reason holdouts cite for not getting a covid vaccine, said Ashley Kirzinger, associate director of public opinion and survey research for KFF. (The KHN newsroom is an editorially independent program of KFF.) This is followed by fear that the vaccine is too new or hasn’t been tested enough.

Kirzinger said it’s important to acknowledge that some people simply can’t be persuaded.

“They don’t see themselves at risk for covid, they think that the vaccine is a greater risk to their health than the virus itself, and there’s really no incentive, no stick, no message, no messenger that’s going to convince these populations,” she said. “It’s going to be really hard to reach the goals set by public health officials, with the decreasing enthusiasm around the vaccine that we have seen in the past several weeks.”

This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

How a Doctor Breaks Norms to Treat Refugees and Recent Immigrants

Tue, 07/27/2021 - 5:00am

AURORA, Colo. — Fatumo Osman, a 65-year-old Somali refugee who speaks limited English, was in a bind. She made too much money at a meal prep service job so she no longer qualified for Medicaid. But knee pain kept her from working, so her income had dropped. She could reapply for Medicaid, get her knee fixed and return to work, at which point she’d lose that safety-net health coverage. Her first step was getting a note from a doctor so she wouldn’t lose her job.

So, Osman came to Mango House, a clinic in this eastern suburb of Denver that caters primarily to refugees and turns no one away, regardless of their ability to pay. Dr. P.J. Parmar designed the clinic to survive on the Medicaid payments that many doctors across the U.S. reject as too low.

The clinic is just one part of a broader refugee ecosystem that Parmar has built. Mango House provides food and clothing assistance, after-school programs, English classes, legal help — and Parmar even leads a Boy Scout troop there. He leases space to nine stores and six restaurants, all owned and run by refugees. Mango House hosts a dozen religious groups, plus community meetings, weddings and other celebrations. When Parmar needs an interpreter for a patient from any of a dozen languages spoken in the building, he can easily grab one of his tenants.

“This is what I call a medical home,” Parmar said.

Although it’s not part of the formal U.S. refugee resettlement program, Mango House is in many ways emblematic of refugee health care in the U.S. It’s a less-than-lucrative field of medicine that often relies on individual physicians willing to eke out a living caring for an underserved and under-resourced population.

Parmar finds creative ways, often flouting norms or skirting rules, to fit his patients’ needs. As a result, Mango House looks nothing like the rest of the U.S. health care system and, at times, draws the ire of the medical establishment.

“How do you deliver the quality of care necessary, and that they deserve, while still keeping the lights on? It’s a struggle for sure,” said Jim Sutton, executive director of the Society of Refugee Healthcare Providers. “It’s these heroes, these champions out there, these cowboys that are taking this on.”

Osman brought her son, Jabarti Yussef, 33, to interpret for her. They have been coming to Mango House for 10 years and said that Parmar opens doors for them when they have trouble accessing care.

“If we ask for an appointment to get Medicaid, P.J. makes the call,” Yussef said. “If we call, we’re on hold for an hour, and then it hangs up. If we go to the ER, it’s a three-hour wait. Here, the majority of people walk in and sit for 30 minutes. It’s good for the community.”

As for Osman’s knee pain, Yussef asked Parmar, could they pay cash to get an MRI at the hospital?

“I can almost guarantee it’s arthritis,” Parmar replied. “You could do an X-ray. That will cost $100. An MRI will cost $500. And if it shows a bigger problem, what are you going to do? It will cost you $100,000.”

Parmar said he would connect them with someone who could help Osman enroll in Medicaid but that it’s an imperfect solution. “Most orthopedists don’t take Medicaid,” Parmar said. Older immigrants need to have worked the equivalent of 10 years in the U.S. to qualify for Medicare.

Medicaid, which covers low-income people, generally pays primary health care providers a third less than Medicare, which covers seniors and the disabled. And both pay even less than commercial insurance plans. Some doctors paint Medicaid patients as more difficult and less likely to follow instructions, show up on time or speak English.

Parmar said he realized back in medical school that few doctors were motivated to treat Medicaid patients. If he limited his practice to just Medicaid, he said dryly, he’d have guaranteed customers and no competition.

So how does he survive on Medicaid rates? By keeping his overhead low. There are no appointments, so no costs for a receptionist or scheduling software.

He said his patients often like that they can drop in anytime and be seen on a first-come, first-served basis, much like an urgent care clinic, and similar to the way things worked in their native countries.

Because he takes only Medicaid, he knows how to bill the program and doesn’t have to hire billing specialists to deal with 10 insurance companies.

It’s also more cost-efficient for the health system. Many of his patients would otherwise go to the emergency room, sometimes avoiding care altogether until their problems get much worse and more expensive to fix.

“Really none of our innovations are new or unique; we just put them together in a unique way to help low-income folks, while making money,” Parmar said. “And then, instead of taking that money home, I put it back into the refugee community.”

The son of Indian immigrants, Parmar, 46, was born in Canada but grew up in Chicago and moved to Colorado after college in 1999, where he did his medical training at the University of Colorado School of Medicine. He opened Mango House 10 years ago, buying a building and renting out space to refugees to cover the cost. Two years ago, he expanded into a vacant J.C. Penney building across the street.

“There’s a good three-, four-year dip in the red here, intentionally, as we move from there to here,” Parmar said. “But that red is going to go away soon.”

The covid pandemic has helped shore up his finances, as federal incentives and payment increases boosted revenue and allowed him to pay down his debt faster.

Parmar must navigate a host of obstacles while working to overcome financial and language barriers. A Muslim Somali woman needs dental care but is uncomfortable seeing a male dentist. A Nepalese woman needs a prescription refill, but she lives in Denver and so has been assigned by Medicaid to the safety-net hospital, Denver Health. Parmar won’t get paid but sees her anyway. Another patient brings paperwork showing he’s being sued by a local health system for a year-old emergency room bill he has no way to pay. A Nepalese man with psoriasis doesn’t want creams or ointments; good medicine, he believes, comes through a needle.

“A lot of this is, basically, geriatrics,” Parmar said. “You have to add 20 years to get their age in refugee years.”

When one patient turns away momentarily, Parmar discreetly throws away her bottle of meloxicam, a strong anti-inflammatory he said she shouldn’t be taking because of her kidney problems. He began stocking over-the-counter medications after realizing his patients got overwhelmed amid 200 varieties of cough and cold medicines at the drugstore. Some couldn’t find what he told them to get, even after he printed flyers showing pictures of the products.

Parmar’s creative solutions, however, often rub many in health care the wrong way. Some balk at his use of family members or others as informal interpreters. Best practices call for the use of trained interpreters who understand medicine and patient privacy rules. But billing for interpretation isn’t possible, so hospitals and clinics must pay interpreters themselves. And that’s beyond the capabilities of most refugee clinics, unless they’re affiliated with a larger health system that can absorb those costs.

“It’s a good thing to have the standards, but it’s another thing altogether to implement them,” said Dr. Pat Walker, an expert on refugee health at the University of Minnesota.

When Mango House began providing covid vaccines, residents of more affluent areas of town started showing up. Parmar tried to limit vaccinations only to those patients living in the immediate area, checking ZIP codes on their IDs. The state stepped in to say he could neither require IDs nor turn away any patients, regardless of his refugee-focused mission.

During a recent lull at the clinic, Parmar took stock of that day’s inventory of patients. Six were assigned to Denver Health, one patient’s Medicaid coverage had expired, and two had high-deductible commercial plans. Chances are he wouldn’t get paid for seeing any of them. Of the 25 patients he had seen that day, 14 had Medicaid coverage that Parmar could bill.

“We see the rest of them anyway,” he said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

As Holdout Missouri Joins Nation in Monitoring Opioid Prescriptions, Experts Worry

Mon, 07/26/2021 - 5:00am

Kathi Arbini said she felt elated when Missouri finally caught up to the other 49 states and approved a statewide prescription drug monitoring program this June in an attempt to curb opioid addiction.

The hairstylist turned activist estimated she made 75 two-hour trips in the past decade from her home in Fenton, a St. Louis suburb, to the state capital, Jefferson City, to convince Republican lawmakers that monitoring how doctors and pharmacists prescribe and dispense controlled substances could help save people like her son, Kevin Mullane.

He was a poet and skateboarder who she said turned to drugs after she and his dad divorced. He started “doctor-shopping” at about age 17 and was able to obtain multiple prescriptions for the pain medication OxyContin. He died in 2009 at 21 from a heroin overdose.

If the state had had a monitoring program, doctors might have detected Mullane’s addiction and, Arbini thinks, her son might still be alive. She said it’s been embarrassing that it’s taken Missouri so long to agree to add one.

“As a parent, you would stand in front of a train; you would protect your child forever — and if this helps, it helps,” said Arbini, 61. “It can’t kill more people, I don’t think.”

But even though Missouri was the lone outlier, it had not been among the states with the highest opioid overdose death rates. Missouri had an average annual rank of 16th among states from 2010 through 2019, as the country descended into an opioid epidemic, according to a KHN analysis of Centers for Disease Control and Prevention data compiled by KFF.

Some in public health now argue that when providers use such monitoring programs to cut off prescription opiate misuse, people who have an addiction instead turn to heroin and fentanyl. That means Missouri’s new toll could cause more people to overdose and leave the state with buyer’s remorse.

“If we can take any benefit from being last in the country to do this, my hope would be that we have had ample opportunity to learn from others’ mistakes and not repeat them,” said Rachel Winograd, a psychologist who leads NoMODeaths, a state program aimed at reducing harm from opioid misuse.

Before Missouri’s monitoring program was approved, lawmakers and health and law enforcement officials warned that the absence made it easier for Missouri patients to doctor-shop to obtain a particular drug, or for providers to overprescribe opiates in what are known as pill mills.

State Sen. Holly Rehder, a Republican with family members who have struggled with opioid addiction, spent almost a decade pushing legislation to establish a monitoring program but ran into opposition from state Sen. Rob Schaaf, a family physician and fellow Republican who expressed concerns about patient privacy and fears about hacking.

In 2017, Schaaf agreed to stop filibustering the legislation and support it if it required that doctors check the database for other prescriptions before writing new ones for a patient. That, though, sparked fresh opposition from the Missouri State Medical Association, concerned the requirement could expose physicians to malpractice lawsuits if patients overdosed.

The new law does not include such a requirement for prescribers. Pharmacists who dispense controlled substances will be required to enter prescriptions into the database.

Dr. Silvia Martins, an epidemiologist at Columbia University who has studied monitoring programs, said it’s important to mandate that prescribers review a patient’s information in the database. “We know that the ones that are most effective are the ones where they check it regularly, on a weekly basis, not just on a monthly basis,” she said.

But Stephen Wood, a nurse practitioner and visiting substance abuse bioethics researcher at Harvard Law School, said the tool is often punitive because it cuts off access to opioids without offering viable treatment options.

He and his colleagues in the intensive care unit at Carney Hospital in Boston don’t use the Massachusetts monitoring program nearly as often as they once did. Instead, he said, they rely on toxicology screens, signs such as injection marks or the patients themselves, who often admit they are addicted.

“Rather than pulling out a piece of paper and being accusatory, I find it’s much better to present myself as a caring provider and sit down and have an honest discussion,” Wood said.

When Kentucky in 2012 became the first state to require prescribers and dispensers to use the system, the number of opioid prescriptions and overdoses from prescription opioids initially decreased slightly, according to a state study.

But the number of opioid overdose deaths — with the exception of a slight dip in 2018 and 2019 — has since consistently ticked upward, according to a KFF analysis of CDC data. In 2020, Kentucky was estimated to have had the nation’s second-largest increase in drug overdose deaths.

When efforts to establish Missouri’s statewide monitoring program stalled, St. Louis County established one in 2017 that 75 local jurisdictions agreed to participate in, covering 85% of the state, according to the county health department. The county now plans to move its program into the state one, which is scheduled to launch in 2023.

Dr. Faisal Khan, director of the county department, said he has no doubt that the St. Louis program has “saved lives across the state.” Opioid prescriptions decreased dramatically once the county established the monitoring program. In 2016, Missouri averaged 80.4 opioid prescriptions per 100 people; in 2019, it was down to 58.3 prescriptions, according to the CDC.

The overall drug overdose death rate in Missouri has steadily increased since 2016, though, with the CDC reporting an initial count of 1,921 people dying from overdoses of all kinds of drugs in 2020.

Khan acknowledged that a monitoring program can lead to an increase in overdose deaths in the years immediately following its establishment because people addicted to prescription opioids suddenly can’t obtain them and instead buy street drugs that are more potent and contain impurities.

But he said a monitoring program can also help a physician intervene before someone becomes addicted. Doctors who flag a patient using the monitoring program must then also be able to easily refer them to treatment, Khan and others said.

“We absolutely are not prepared for that in Missouri,” said Winograd, of NoMODeaths. “Substance use treatment providers will frequently tell you that they are at max capacity.”

Uninsured people in rural areas may have to wait five weeks for inpatient or outpatient treatment at state-funded centers, according to PreventEd, a St. Louis-based nonprofit that aims to reduce harm from alcohol and drug use.

For example, the waiting list for residential treatment at the Preferred Family Healthcare clinic in Trenton is typically two weeks during the summer and one month in winter, according to Melanie Tipton, who directs clinical services at the center, which mostly serves uninsured clients in rural northern Missouri.

Tipton, who has worked at the clinic for 17 years, said that before the covid-19 pandemic, people struggling with opioid addiction mainly used prescription pills; now it’s mostly heroin and fentanyl, because they are cheaper. Fentanyl is a synthetic opioid that is 50 to 100 times more potent than morphine, according to the National Institute on Drug Abuse.

Still, Tipton said her clients continue to find providers who overprescribe opiates, so she thinks a statewide monitoring program could help.

Inez Davis, diversion program manager for the Drug Enforcement Administration’s St. Louis division, also said in an email that the program will benefit Missouri and neighboring states because “doctor shoppers and those who commit prescription fraud now have one less avenue.”

Winograd said it’s possible that if the state had more opioid prescription pill mills, it would have a lower overdose death rate. “I don’t think that’s the answer,” she said. “We need to move in the direction of decriminalization and a regulated drug supply.” Specifically, she’d rather Missouri decriminalize possession of small amounts of hard drugs, even heroin, and institute regulations to ensure the drugs are safe.

State Rep. Justin Hill, a Republican from St. Charles and former narcotics detective, opposed the monitoring program legislation because of his concerns over patient privacy and evidence that the lack of a program has not made Missouri’s opioid problem any worse than many other states’. He also worries the monitoring program will lead to an increase in overdose deaths.

“I would love the people that passed this bill to stand by the numbers,” Hill said. “And if we see more deaths from overdose, scrap the monitoring program and go back to the drawing board.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

The Pandemic Made Telemedicine an Instant Hit. Patients and Providers Feel the Growing Pains.

Mon, 07/26/2021 - 5:00am

Crystal Joseph pays for two telemedicine video services to ensure that her small therapy practice in Silver Spring, Maryland, can always connect with its clients.

She’s been burned before. During one hours-long service outage of SimplePractice in late May, PsycYourMind, which offers mental health counseling and group sessions for Black patients, lost about $600 because of missed appointments. Livid, Joseph requested a small credit from the telemedicine service, which costs $432 monthly for her team of clinicians and trainees. SimplePractice refused, she said.

“What they offer is phenomenal, especially being founded by a therapist,” said Joseph, a licensed clinical professional counselor. “But with a private practice, if you don’t get paid, you don’t eat.” For some sessions, she was able to hop onto her backup, VSee, which costs her $49 each month. Some of her peers use Zoom. But even though Joseph keeps links to both her SimplePractice and VSee accounts in her email signature, a last-minute switch-up can feel messy for clients, and she never charges a no-show fee when it’s an “act of God.”

Major health systems, clinics and private practices alike pivoted swiftly to telemedicine when the covid-19 pandemic forced the nation to shelter in place and patients could no longer safely venture into health care settings. But the video services were not equally prepared for the titanic influx in users, said Kapil Chalil Madathil, an engineering professor at Clemson University who has researched how easy — or difficult — telemedicine platforms are to use.

Videoconferencing vendors, including Zoom, tech giants like Microsoft and Cisco, and a host of telemedicine startups absorbed an explosion of demand over the past pandemic months. PitchBook estimates that revenue from the global telehealth market will hit $312.3 billion in 2026, up from $65.5 billion in 2019. But beyond connectivity issues, some services seemed designed for dissatisfaction. They required patients to download a desktop application or made them click through multiple steps to log in. “On an iPhone, I can click one button to see my grandkids,” Madathil said. “Can we not make telemedicine systems as easy as that?”

Providers often were locked in with telemedicine options from services they were already using — or what they could afford. Joseph was already paying SimplePractice to house her practice’s electronic health records, so moving to another platform would have been time-consuming and costly, she said.

Practitioners have depended on telemedicine to keep their businesses afloat in the pandemic, and Joseph plans to keep a portion of her sessions virtual. A one-stop shop for private practice clinicians, SimplePractice offers scheduling, an electronic medical records system and insurance claims filing along with its video services. The company said it hosted 17 million telehealth appointments last year.

“The expectations are rising,” said Diana Stepner, a SimplePractice vice president. “Individuals want screen sharing, they want grid views, so we’ve added new capabilities since the pandemic began and will continue to do so.”

Zoom became an overnight poster child for staying connected as employees in every line of business across the country worked from home. Its revenue jumped 326% in the fiscal year that ended on Jan. 31, 2021, over the previous year’s. Even before the pandemic, the Silicon Valley company offered a service tailored for health care practitioners that complied with the Health Insurance Portability and Accountability Act, which protects patient privacy, and could be synced with Epic Systems electronic medical records.

“It was ‘all bets are off’ once the pandemic hit,” said Heidi West, who heads the health care division at Zoom. West pointed to the CARES Act and the loosening of telehealth regulations, which allowed doctors to be reimbursed for telemedicine at the same rate as for in-office visits.

UCSF Health, which had contracted with Zoom for virtual visits since 2016, gave every doctor and clinician a personal link for its videoconference line and a separate virtual waiting room. Telemedicine calls for outpatient care within the San Francisco academic medical system spiked from 2% of visits in February 2020 to more than 60% by that April. Doctors were seeing patients — who often used their cellphones — in their homes, in parked cars and in one case on skyscraper scaffolding, where a construction worker stepped away for a quick doctor’s visit, said Linda Branagan, director of telehealth at UCSF Health.

Zoom is not immune to glitches, Branagan said, but it seems to bounce back faster than many other vendors and “recovers quite gracefully.”

UCSF surveyed its patients and found they were more satisfied with their video visits than their in-person ones. More than a year later, almost one-third of outpatient visits are still conducted virtually.

Elsewhere, the initial transition was rockier. Dr. James McElligott, who runs Medical University of South Carolina’s Center for Telehealth, said the hospital could not afford to upgrade its Vidyo conferencing system, so he opted for, which the center already used for research and had an easy-to-use interface.

“We were able to get clever, and many doctors really liked it,” McElligott said. The software has a waiting room from which patients can be transferred into virtual rooms with providers. The health system sent patients a text with a direct link for their appointments so that they didn’t lose time.

“But we couldn’t control quality or solve connectivity issues ourselves,” he said. “We did have a lot of patients who, despite it just being a link, were uncomfortable waiting.” That led to some patients abandoning visits, he added. employed just eight people when the video telemedicine service saw an unwieldy increase in users in March 2020. For two weeks straight, the company signed up 20,000 new health care providers a day, said founder and CEO Brandon Welch, amassing a backlog of customer service inquiries. One day, Welch recalled, there was a 30-second queue for the website to load because so many people were logging on simultaneously.

“We hired anyone who could walk and chew gum at the same time,” joked Welch, noting that many of those early pandemic hires, largely tackling customer service, had been recently laid off from other industries, like restaurants. automated the sign-up process as quickly as possible. The service ballooned from 80,000 users to 850,000 as it assembled a team of 120 employees. And it is still hiring. Doctors and clinicians can sign up for the basic HIPAA-compliant service — which includes audio, video and a patient waiting room — at no charge. But for enhanced options, like screen sharing or shared rooms, there’s a price tag of at least $29 a month.

For many doctors and clinicians, the move to virtual visits may be permanent, even with all the technical hiccups. A survey conducted by SimplePractice of over 2,400 clinicians in February found that 88% expected to continue offering a telehealth option.

Jessica Ehrman, a Santa Monica, California, therapist who plans to keep her practice fully remote, finds telemedicine much easier for scheduling, particularly for kids who have short windows of availability. Still, connectivity issues during that small time frame can tarnish the whole session.

“If you’re talking about deep childhood trauma — having your connection time out then? It’s really frustrating when we’re paying for a service,” said Ehrman, who has been suddenly dropped from sessions, experienced lags and even once saw back-end coding pop up in her provider portal. Like Joseph in Maryland, she uses SimplePractice through her agency and personally pays for Zoom’s HIPAA-compliant option to head off technical difficulties.

Despite the problems, few health care providers want to forsake the technology. “Video visits are cemented,” said Branagan. “I will never again have to have a conversation with a physician to convince them that you can do health care via video.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Watch: More Long-Covid Cases Seen in Kids

Mon, 07/26/2021 - 5:00am

The vast majority of the pandemic’s 4.1 million covid infections in children have been mild. However, doctors are concerned about a growing number of long-haul covid cases and a rare but dangerous inflammatory disease, particularly among Black and Latino children. KHN correspondent Sarah Varney, in collaboration with PBS NewsHour, reports on the phenomena. This story aired on July 23, 2021.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Journalists Dig in on Delta Variant Risks and Opioid Overdose Deaths

Sat, 07/24/2021 - 5:00am

KHN Midwest correspondent Lauren Weber discussed outbreaks caused by the covid-19 delta variant in Missouri and elsewhere on Newsy on Thursday.

KHN correspondent Aneri Pattani discussed opioids and the rise in overdose deaths on Newsy’s “Morning Rush” on July 16.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Facing Headwinds on New Alzheimer’s Drug, Biogen Launches Controversial Campaign

Fri, 07/23/2021 - 5:00am

Do you sometimes lose your train of thought or feel a bit more anxious than is typical for you?

Those are two of the six questions in a quiz on a website co-sponsored by the makers of Aduhelm, a controversial new Alzheimer’s drug. But even when all responses to the frequency of those experiences are “never,” the quiz issues a “talk to your doctor” recommendation about the potential need for additional cognitive testing.

Facing a host of challenges, Aduhelm’s makers Biogen and its partner Eisai are taking a page right out of a classic marketing playbook: Run an educational campaign directed at the consumer, one who is already worried about whether those lost keys or a hard-to-recall name is a sign of something grave.

The campaign — which also includes a detailed advertisement on The New York Times’ website, a Facebook page and partnerships aimed at increasing the number of places where consumers can get cognitive testing — is drawing fire from critics. They say it uses misleading information to tout a drug whose effectiveness is widely questioned.

“It’s particularly egregious because they are trying to convince people with either normal memories or normal age-related decline that they are ill and they need a drug,” said Dr. Adriane Fugh-Berman, a pharmacology professor at Georgetown University Medical Center, who wrote about the website in an opinion piece. 

The website’s “symptoms quiz” asks about several common concerns, such as how often a person feels depressed, struggles to come up with a word, asks the same questions over and over, or gets lost. Readers can answer “never,” “almost never,” “fairly often” or “often.” No matter the answers, however, it directs quiz takers to talk with their doctors about their concerns and whether additional testing is needed.

While some of those concerns can be symptoms of dementia or cognitive impairment, “this clearly does overly medicalize very common events that most adults experience in the course of daily life: Who hasn’t lost one’s train of thought or the thread of a conversation, book or movie? Who hasn’t had trouble finding the right word for something?” said Dr. Jerry Avorn, a professor of medicine at Harvard Medical School who has been sharply critical of the approval.

Aduhelm was approved in June by the Food and Drug Administration, but that came after an FDA advisory panel recommended against it, citing a lack of definitive evidence that it works to slow the progression of the disease. The FDA, however, granted what is called “accelerated approval,” based on the drug’s ability to reduce a type of amyloid plaque in the brain. That plaque has been associated with Alzheimer’s patients, but its role in the disease is still being studied.

News reports also have raised questions about FDA officials’ efforts to help Biogen get Aduhelm approved. And consumer advocates have decried the $56,000-a-year price tag that Biogen has set for the drug.      

On the day it was approved, Patrizia Cavazzoni, the FDA’s director of the Center for Drug Evaluation and Research, said the trial results showed it substantially reduced amyloid plaques and “is reasonably likely to result in clinical benefit.”

Describing the website as part of a “disease awareness educational program,” Biogen spokesperson Allison Parks said in an email that it is aimed at “cognitive health and the importance of early detection.” She noted that the campaign does not mention the drug by name.

Earlier Thursday, in “an open letter to the Alzheimer’s disease community,” Biogen’s head of research, Dr. Alfred Sandrock, noted the drug is the first one approved for the condition since 2003 and said it has been the subject of “extensive misinformation and misunderstanding.” Sandrock stressed a need to offer it quickly to those who have only just begun to experience symptoms so they can be treated before the disease moves “beyond the stages at which Aduhelm should be initiated.”

While the drug has critics, it is also welcomed by some patients, who see it as a glimmer of hope. The Alzheimer’s Association pushed for the approval so that patients would have a new option for treatment, although the group has objected to Biogen’s pricing and the fact that it has nine years to submit follow-up effectiveness studies.

“We applaud the FDA’s decision,” said Maria Carrillo, chief science officer for the association. “There’s a benefit to having access to it now” because it is aimed at those in the early stages of dementia. Those patients want even a modest slowdown in disease progression so they have more time to do the things they want to accomplish, she said.

The drug is given by infusion every four weeks. It also requires expensive associated care. About 40% of the patients in the trials experienced brain swelling or bleeds, so regular brain imaging scans are also required, according to clinical trial results and the drug’s label. In addition, patients will likely need to be checked for amyloid protein, which is done with expensive PET scans or invasive spinal taps, according to Alzheimer’s experts.

To educate more potential patients, and customers, Biogen announced it has teamed with CVS to offer cognitive testing, and with free clinics for dementia education efforts. 

Biogen is also picking up some of the laboratory costs for patients who get a spinal tap.

Still, the drug faces headwinds: There’s a congressional probe of the drug’s approval, the head of the FDA has called for an independent investigation of its review process, and there’s pushback from policy experts and insurers over its price, which they say could seriously strain Medicare’s finances. Some medical systems, including the Cleveland Clinic and Mount Sinai, say they won’t administer it, citing efficacy and safety data.    

None of that is mentioned in Biogen’s campaign.

Instead, the advertisements and websites focus on what is called mild cognitive impairment, including a warning that 1 in 12 people over age 50 have that condition, which it describes as the earliest clinical stage of Alzheimer’s.

On its website, Biogen doesn’t cite where that statistic comes from. When asked for the source, Parks said Biogen’s researchers made some mathematical calculations based on U.S. population data and data from a January 2018 article in the journal Neurology.

Some experts say that percentage seems high, particularly on the younger end of that spectrum.

“I can’t find any evidence to support the claim that 1 in 12 Americans over age 50 have MCI due to Alzheimer’s disease. I do not believe it is accurate,” said Dr. Matthew S. Schrag, a vascular neurologist and assistant professor of neurology at Vanderbilt University Medical Center in Nashville, Tennessee.

While some people who have mild cognitive impairment progress to Alzheimer’s — about 20% over three years — most do not, said Schrag: “It’s important to tell patients that a diagnosis of MCI is not the same as a diagnosis of Alzheimer’s.”

Mild cognitive impairment is tricky to diagnose — and not something a simple six-question quiz can uncover, said Mary Sano, director of the Alzheimer’s Disease Research Center at the Icahn School of Medicine at Mount Sinai in New York.

“The first thing to determine is whether it’s a new memory problem or a long-standing poor memory,” said Sano, who said a physician visit can help patients suss this out. “Is it due to some other medical condition or a lifestyle change?”

Carrillo, at the Alzheimer’s Association, agreed that MCI can have many causes, including poor sleep, depression or taking certain prescription medications.

Based on a review of medical literature, her organization estimates that about 8% of people over age 65 have mild cognitive impairment due to the disease.

She declined to comment on the Biogen campaign but did say that early detection of Alzheimer’s is important and that patients should seek out their physicians if they have concerns rather than rely on “a take-at-home quiz.”

Schrag, however, minced no words in his opinion of the campaign, saying it “feels like an agenda to expand the diagnosis of cognitive impairment in patients because that is the group they are marketing to.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: National News Content

Readers and Tweeters Connect the Dots on Topics From Vaccine Development to Long Covid

Fri, 07/23/2021 - 5:00am

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

A Concerned Taxpayer Takes Stock of Vaccine Efforts

Your recent article “Novavax’s Effort to Vaccinate the World, From Zero to Not Quite Warp Speed” (July 19) seems to reveal Maryland-based Novavax as a corporation that is misusing a vast amount of taxpayers’ money so its CEO (and other officers) can make a killing selling stocks.

Novavax has contracted with many foreign countries (Spain, India and Japan, etc.) to produce vaccines (or components) meant to treat world populations in need of a means to arrest the widespread scourge of covid-19. Your article mentions how little yield of product has followed, given the financial investments made.

I find it particularly disturbing that some of Novavax’s corporate officers are benefiting by selling large blocks of stocks. In fact, I find it to be unconscionable, given the many who have died for lack of a remedy that has gone unfulfilled and, in this case, an initiative that’s overfunded.

I wish you would transmit your article to each and every member of Congress, in the hope that those who can will investigate how the funds doled out in the name of “Operation Warp Speed” are being misused, and unaccounted for.

— Carl Anderson, Baltimore

Novavax is a great vaccine, but this article shows how hard it is for a company to become a mass-vaccine producer starting from a base of zero.

— Dr Helen MacLean (@DrHMacLean) July 19, 2021

Waiting in Vain for a Novavax Vaccine?

Thank you for the article on Novavax (“Novavax’s Effort to Vaccinate the World, From Zero to Not Quite Warp Speed,” July 19). I have been searching the web regularly to find new information on this vaccine and when it might become available; most days I come up with nothing new. Your article was thorough and informative and, although I do take exception to your statement that “America is awash with vaccine options,” the information provided was very enlightening.

Many people are wary of the mRNA vaccine technology, and Johnson & Johnson hasn’t turned out to be an optimal choice, due to side effects (albeit rare) and lower efficacy. My own humble opinion is that Novavax could be of significant interest to unvaccinated Americans, depending on how the accompanying narrative is presented (e.g., tried-and-true traditional technology). Now that we have a rising surge once again in covid-19, it seems like an optimal time to introduce another vaccine option for Americans, but based on your excellent reporting, it sounds like it may not be Novavax.

— Holly King, Indianapolis

I would say this is to deter people from going to the ER for any kind of pain. I will never go to one again. I will not pay someone to be cruel to me. I can suffer better at home than in a cold, cruel ER.

— Kat Melcher
Categories: National News Content