Recent polling shows that no matter which tactics are used, a strong majority of unvaccinated people are unlikely to budge on getting a shot.

This article was published on Tuesday, July 27, 2021 in Kaiser Health News.

By Anna Almendrala

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.

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 Healthcare Foundation.

Anna Almendrala: aalmendrala@kff.org, @annaalmendrala

Some in public health now argue that monitoring programs to cut off prescription opiate misuse, will push addicts to use heroin and fentanyl.

This article was published on Monday, July 26, 2021 in Kaiser Health News.

By Eric Berger

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."

Despite the ACA's guarantees of free contraception coverage, even for women whose health plans are subject to the law's requirements, obtaining the right product at no cost can be onerous.

This article was posted on Friday, July 23, 2021 in Kaiser Health News.

By Michelle Andrews

For Stephanie Force, finding a birth control method that she likes and can get without paying out-of-pocket has been a struggle, despite the Affordable Care Act's promise of free contraceptives for women and adolescent girls in most health plans.

The 27-year-old physician recruiter in Roanoke, Virginia, was perfectly happy with the NuvaRing, a flexible vaginal ring that women insert monthly to release hormones to prevent pregnancy. But her insurer, Anthem, stopped covering the branded product and switched her to a generic version in early 2020. Force said the new product left her with headaches and feeling irritable and short-tempered.

After talking to her OB-GYN, Force tried an IUD. But that made her feel worse: She had bad cramps, gained 10 pounds and developed severe hormonal acne. Plus, she was charged $248 for an ultrasound her provider used to guide the insertion of the device, a charge she successfully fought.

Force also considered a couple of birth control products approved in recent years: a non-hormonal vaginal gel called Phexxi and a vaginal ring called Annovera that can be used for a year. But Phexxi isn't covered by her employer health plan, and she would owe a $45 copayment for Annovera.

Despite the ACA's guarantees of free contraception coverage, Force's experience illustrates that even for women whose health plans are subject to the law's requirements, obtaining the right product at no cost can be onerous. New types of contraceptives aren't automatically incorporated into the federal list of required methods that insurers use to guide coverage decisions. In addition, some health plans continue to discourage use of even long-established methods like IUDs by requiring providers to get approval from the plan before prescribing them.

Consumer advocates who have studied the issue say a process is spelled out in federal rules for women to get the contraceptive they need, but far too few people know that is an option.

Ultimately, Force went back to the generic version of the NuvaRing, despite the side effects she continues to experience. She'd prefer to be on the branded NuvaRing, which didn't give her problems, and the ping-ponging from method to method has left her exhausted and furious.

"I cannot believe what hoops I have had to jump through between September 2020 and June 2021," Force said, "between switching from the generic NuvaRing to the IUD and then back, fighting my insurance and OB-GYN's office on the ultrasound charge."

In a statement, Anthem said, "Anthem health plans cover 222 contraceptive products at $0 cost share on our ACA Preventive List. We cover at least one product" in each of 18 categories of contraception methods approved by the FDA.

Contraception is a very personal choice, and what meets one woman's needs may not meet another's. If avoiding pregnancy is a woman's top priority, a virtually fail-safe method like an IUD may be the right solution. But for someone who's considering getting pregnant soon, a readily reversible method like a birth control pill might be the best option. Side effects are important to consider as well, since women respond differently to the hormones in various birth control products.

Before the ACA required no-cost birth control coverage, researchers estimate, up to 44% of women's out-of-pocket healthcare spending went toward contraceptives. The ACA required most commercial health plans to cover a comprehensive list of FDA-approved methods without charging women anything. Church plans and religious nonprofits as well as employers and schools that object to contraception are exempt from the coverage requirements. Plans that were grandfathered under the law are also exempt. Uninsured women don't benefit from the mandate either.

But the federal rules do not require health plans to cover every contraceptive. After the ACA passed in 2010, the federal Health Resources & Services Administration developed guidelines for women's preventive services. Those guidelines say women should have access without cost sharing to a list that covers the 18 FDA-approved methods, including oral contraceptives, vaginal rings and cervical caps, IUDs, implantable rods and sterilization. Under federal rules, health plans must cover at least one product in each category.

But neither the HRSA guidelines nor a birth control chart published by the FDA addresses newer methods, including the gel Phexxi, which regulates vaginal acidity to reduce the odds a sperm reaches an egg. It was approved by the FDA last year.

Nor do they incorporate fertility-awareness mobile apps the FDA approved in recent years such as Natural Cycles, which tracks a woman's temperature and menstrual cycle to avoid pregnancy.

"There's a real need for new guidance that keeps up with new methods," said Mara Gandal-Powers, director of birth control access at the National Women's Law Center.

Many insurers have balked at covering Phexxi, said Rameshwari Gupta, director of strategic markets for Evofem Biosciences, which markets Phexxi. A box of 12 single-use applicators — consumers use one before having sex — costs $267.50 without insurance, she said.

"When I started talking to payers, they all said, 'Where are you on this FDA chart?'" she said.

According to an FDA spokesperson, the birth control chart is for consumer education purposes only and "was not created with the intent of driving coverage decisions." The agency is in the process of updating it.

In a statement, HRSA said it is reviewing the evidence on contraceptives and expects to complete its review late this year. If it opts to make revisions, it will publish draft recommendations to update the women's preventive services guidelines. These will be finalized after a public comment period and become effective a year later.

At this point, health plans consider Phexxi a spermicide and are required to cover only one type of spermicide without cost sharing, said Kristine Grow, a senior vice president at AHIP, a health insurance trade organization.

"If Phexxi is indeed considered a new 'method' of contraception, both the FDA and HRSA would need to make this clear," she added.

The vaginal ring Annovera, approved by the FDA in 2018, is typically covered by health plans, according to Grow, though it may not be available without cost sharing. The average retail price is $2,457 a year, according to GoodRx.

One way plans have made it difficult for women to access certain contraceptives, even those on the list of approved methods, is by requiring that their providers get approval from the insurer first, often by providing documentation that the product is medically necessary.

Under UnitedHealthcare's coverage policy for Phexxi, for example, before coverage will be authorized, members must have documented reasons that they are unable to use eight other contraceptive methods, including oral contraceptives, the contraceptive patch, a vaginal ring, injections and spermicides. Providers also must attest that they have counseled patients that Phexxi is less effective at preventing pregnancy than some other methods.

In a statement, UHC said it covers "a broad array" of generic and brand-name options, and it follows scientific evidence to develop its list.

Yet consumers have a way to get the specific drug that is most appropriate for them, according to a report by the National Women's Law Center.

Under federal rules, if a doctor or other healthcare provider determines that a patient needs a particular contraceptive, even if it's not on the list of approved products for the patient's plan, the insurer is required to have an expedient process for the patient to seek a waiver.

"It's not up to the insurance company whether to cover that method; it's up to the provider," said Adam Sonfield, executive editor for policy analysis at the Guttmacher Institute, a research and advocacy organization focused on women's reproductive health.

But according to the National Women's Law Center report, many insurers, patients and their providers aren't aware of the requirement, and state agencies don't enforce these so-called exceptions policies.

If patients run into trouble getting the method they want, "we typically recommend filing an appeal with their insurance provider," said Gretchen Borchelt, vice president for reproductive rights and health at the National Women's Law Center.

Stephanie Force said she was unaware of any process she could have used to get the NuvaRing covered without cost sharing. Neither her healthcare provider nor the insurer mentioned the possibility.

She recently had an appointment with a new provider, who she hopes will be a better advocate for her.

Michelle Andrews: andrews.khn@gmail.com, @mandrews110

The drugmaker is running 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.

This article was published on Friday, July 23, 2021 in Kaiser Health News.

By Julie Appleby

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."

Julie Appleby: jappleby@kff.org, @Julie_Appleby