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The Path to a Better Tuberculosis Vaccine Runs Through Montana

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Jim Robbins
Thu, 18 Apr 2024 09:00:00 +0000

A team of Montana researchers is playing a key role in the development of a more effective vaccine against tuberculosis, an infectious disease that has killed more people than any other.

The BCG (Bacille Calmette-Guérin) vaccine, created in 1921, remains the sole TB vaccine. While it is 40% to 80% effective in young , its efficacy is very low in adolescents and adults, leading to a worldwide push to create a more powerful vaccine.

One effort is underway at the of Montana Center for Translational Medicine. The center specializes in improving and creating vaccines by adding what are called novel adjuvants. An adjuvant is a substance included in the vaccine, such as fat molecules or aluminum salts, that enhances the immune response, and novel adjuvants are those that have not yet been used in humans. Scientists are finding that adjuvants make for stronger, more precise, and more durable immunity than antigens, which create antibodies, would alone.

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Eliciting specific responses from the immune system and deepening and broadening the response with adjuvants is known as precision vaccination. “It's not one-size-fits-all,” said Ofer Levy, a professor of pediatrics at Harvard University and the head of the Precision Vaccines Program at Boston Children's Hospital. “A vaccine might work differently in a newborn versus an older adult and a middle-aged person.”

The ultimate precision vaccine, said Levy, would be lifelong protection from a disease with one jab. “A single-shot protection against influenza or a single-shot protection against covid, that would be the holy grail,” Levy said.

Jay Evans, the director of the University of Montana center and the chief scientific and strategy officer and a co-founder of Inimmune, a privately held biotechnology company in Missoula, said his team has been working on a TB vaccine for 15 years. The private-public partnership is developing vaccines and to improve existing vaccines, and he said it's still five years off before the TB vaccine might be distributed widely.

It has not gone unnoticed at the center that this -of-the-art vaccine research and production is located in a state that passed one of the nation's most extreme anti-vaccination laws during the pandemic in 2021. The prohibits businesses and governments from discriminating against people who aren't vaccinated against covid-19 or other diseases, effectively banning both public and private employers from requiring workers to get vaccinated against covid or any other disease. A federal judge later ruled that the law cannot be enforced in settings, such as hospitals and doctors' offices.

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In mid-March, the Bill & Melinda Gates Medical Research Institute announced it had begun the third and final phase of clinical trials for the new vaccine in seven countries. The trials should take about five years to complete. Research and production are being done in several places, at a manufacturing facility in Hamilton owned by GSK, a giant pharmaceutical company.

Known as the forgotten pandemic, TB kills up to 1.6 million people a year, mostly in impoverished in Asia and Africa, despite its being both preventable and treatable. The U.S. has seen an increase in tuberculosis over the past decade, especially with the influx of migrants, and the number of cases rose by 16% from 2022 to 2023. Tuberculosis is the leading cause of among people living with HIV, whose risk of contracting a TB infection is 20 times as great as people without HIV.

“TB is a complex pathogen that has been with human beings for ages,” said Alemnew Dagnew, who heads the program for the new vaccine for the Gates Medical Research Institute. “Because it has been with human beings for many years, it has evolved and has a mechanism to escape the immune system. And the immunology of TB is not fully understood.”

The University of Montana Center for Translational Medicine and Inimmune together have 80 employees who specialize in researching a range of adjuvants to understand the specifics of immune responses to different substances. “You have to tailor it like tools in a toolbox towards the pathogen you are vaccinating against,” Evans said. “We have a whole library of adjuvant molecules and formulations.”

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Vaccines are made more precise largely by using adjuvants. There are three basic types of natural adjuvants: aluminum salts; squalene, which is made from shark liver; and some kinds of saponins, which are fat molecules. It's not fully understood how they stimulate the immune system. The center in Missoula has also created and patented a synthetic adjuvant, UM-1098, that drives a specific type of immune response and will be added to new vaccines.

One of the most promising molecules being used to juice up the immune system response to vaccines is a saponin molecule from the bark of the quillay tree, gathered in Chile from trees at least 10 years old. Such molecules were used by Novavax in its covid vaccine and by GSK in its widely used shingles vaccine, Shingrix. These molecules are also a key component in the new tuberculosis vaccine, known as the M72 vaccine.

But there is room for improvement.

“The vaccine shows 50% efficacy, which doesn't sound like much, but basically there is no effective vaccine currently, so 50% is better than what's out there,” Evans said. “We're looking to take what we learned from that vaccine development with additional adjuvants to try and make it even better and move 50% to 80% or more.”

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By contrast, measles vaccines are 95% effective.

According to Medscape, around 15 vaccine candidates are being developed to replace the BCG vaccine, and three of them are in phase 3 clinical trials.

One approach Evans' center is researching to improve the new vaccine's efficacy is taking a piece of the bacterium that causes TB, synthesizing it, and combining it with the adjuvant QS-21, made from the quillay tree. “It stimulates the immune system in a way that is specific to TB and it drives an immune response that is even closer to what we get from natural infections,” Evans said.

The University of Montana center is researching the treatment of several problems not commonly thought of as treatable with vaccines. They are entering the first phase of clinical trials for a vaccine for allergies, for instance, and first-phase trials for a cancer vaccine. And later this year, clinical trials will begin for vaccines to block the effects of opioids like heroin and fentanyl. The University of Montana received the largest grant in its history, $33 million, for anti-opioid vaccine research. It works by creating an antibody that binds with the drug in the bloodstream, which keeps it from entering the brain and creating the high.

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For now, though, the eyes of health care experts around the world are on the trials for the new TB vaccines, which, if they are successful, could save countless lives in the world's poorest places.

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By: Jim Robbins
Title: The Path to a Better Tuberculosis Vaccine Runs Through Montana
Sourced From: kffhealthnews.org/news/article/new-better-tuberculosis-tb-vaccine-montana/
Published Date: Thu, 18 Apr 2024 09:00:00 +0000

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Exclusive: Senator Urges Biden Administration To Thwart Fraudulent Obamacare Enrollments

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Julie Appleby, KFF
Tue, 21 May 2024 15:45:00 +0000

Stronger actions are needed immediately to thwart insurance brokers who fraudulently enroll or switch people in Affordable Care Act coverage, Sen. Ron Wyden, chairman of the powerful Senate Finance Committee, said Monday.

“We want the Centers for Medicare & Services to hold these brokers criminally responsible for ripping people off this way,” he told KFF Health News.

In a sharply worded letter sent to CMS Administrator Chiquita Brooks-LaSure, the Oregon Democrat expressed “outrage” over the practice, which nets unscrupulous agents commission payments while leaving consumers with a potential host of problems, from losing access to their regular doctors or treatments to higher deductibles and even owing taxes.

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Noting that tens of thousands of Americans have been victimized, Wyden called on regulators to step up enforcement and be more proactive in notifying potentially affected consumers. He vowed to introduce legislation that would make participating in such schemes subject to criminal penalties.

“CMS must do more and you must do it now,” he wrote in his letter.

Complaints about such unauthorized enrollment schemes have grown in recent months. KFF Health News has reported that unscrupulous brokers or agents can easily access policyholder information to change their coverage through private commercial platforms integrated with the federal Obamacare marketplace, healthcare.gov, which serves 32 states.

The for federal regulators is to thwart the activity without reducing enrollment — a top priority for President Joe Biden's administration.

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CMS, which oversees the federal website, said it's working on regulatory and technological fixes and can suspend or terminate problem agents' access to healthcare.gov.

The agency will respond directly to Wyden, said Jeff Wu, acting director of CMS' Center for Consumer Information & Insurance Oversight, in a written statement. He further noted that the agency is “consistently evaluating opportunities to identify and resolve issues sooner, including through outreach, technical assistance, and compliance actions.”

Ronnell Nolan, president and of Health Agents for America, whose group has been outspoken about the need for regulators to do more, welcomed Wyden's involvement and the potential for criminal penalties for perpetrators.

“It's a when a person's insurance is taken from them when they're in the middle of cancer treatment or on a transplant list and they're put in a predicament where they might lose their because of the fraudulent activity,” she said.

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After initially declining to quantify the problem, CMS this month issued a statement saying it had received more than 90,000 complaints in the first quarter of 2024 about unauthorized enrollments and plan switches. While the number of complaints represents a small percentage of the more than 16 million enrollments processed through healthcare.gov for this year's coverage, it may understate the breadth of the problem, as complaints likely don't reflect the magnitude of cases.

Although Wyden lauded CMS' efforts to fix problems already encountered by consumers, he said in his letter that the agency needs to be more proactive about preventing them.

He urged regulators to contact potentially affected consumers instead of waiting to investigate only after a policyholder files a complaint, which sometimes doesn't occur until weeks or months after a plan is switched.

It can be difficult for victims to recognize the changes. Rogue agents don't obtain their consent, and many are signed up for plans that have no monthly premiums, so they don't get a bill. Other consumers unknowingly enroll when they respond to misleading marketing promising gift cards, “government subsidies,” or other financial help.

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Rather than wait for a consumer to complain, regulators could reach out directly when they see a policy submitted or changed by a broker or agency that has been found to be fraudulently enrolling others, Wyden wrote.

Wyden also said CMS should use its authority to impose civil penalties, up to $250,000, against “brokers who submit fraudulent enrollments.”

“I am disappointed these penalties have not yet been used to hold bad actors accountable,” he wrote.

Finally, he wants the agency to review private-sector platforms used by agents and brokers to enroll consumers in ACA plans. Those private companies are not used by 18 states and the District of Columbia, which their own ACA marketplaces. The -run marketplaces impose additional layers of identity-proofing and other security measures and have reported far fewer problems with unauthorized enrollment.

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Dozens of private “enhanced direct enrollment” entities are certified by CMS to integrate with healthcare.gov. Their involvement was expanded during the Trump administration, which also sharply reduced for nonprofits to help with outreach and enrollment.

The platforms were designed to be simpler to use than healthcare.gov. But they have drawn criticism from agents, who say the private websites make it too easy for unscrupulous brokers or others to access policyholder information and make changes. Currently, more than half of federal marketplace enrollments are assisted by agents or brokers, and most act legitimately, regulators and others say.

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By: Julie Appleby, KFF Health News
Title: Exclusive: Senator Urges Biden Administration To Thwart Fraudulent Obamacare Enrollments
Sourced From: kffhealthnews.org/news/article/aca-enrollment-fraud-senator-ron-wyden-urges-biden-administration-crackdown/
Published Date: Tue, 21 May 2024 15:45:00 +0000

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High Price of Popular Diabetes Drugs Deprives Low-Income People of Effective Treatment

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Renuka Rayasam
Tue, 21 May 2024 09:00:00 +0000

For the past year and a half, Tandra Cooper Harris and her husband, Marcus, who both have diabetes, have struggled to fill their prescriptions for the medications they need to control their blood sugar.

Without Ozempic or a similar drug, Cooper Harris suffers blackouts, becomes too tired to watch her grandchildren, and struggles to earn extra money braiding hair. Marcus Harris, who works as a Waffle House cook, needs Trulicity to keep his legs and feet from swelling and bruising.

The 's doctor has tried prescribing similar , which mimic a hormone that suppresses appetite and controls blood sugar by boosting insulin production. But those, too, are often out of stock. Other times, their insurance through the Affordable Care Act marketplace burdens the couple with a lengthy approval process or an out-of-pocket cost they can't afford.

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“It's like, I'm to jump through hoops to live,” said Cooper Harris, 46, a of Covington, Georgia, east of Atlanta.

Supply shortages and insurance hurdles for this powerful class of drugs, called GLP-1 agonists, have left many people who are suffering from diabetes and obesity without the medicines they need to stay healthy.

One root of the problem is the very high prices set by drugmakers. About 54% of adults who had taken a GLP-1 drug, including those with insurance, said the cost was “difficult” to afford, according to KFF poll results released this month. But it is patients with the lowest disposable incomes who are being hit the hardest. These are people with few resources who struggle to see and buy healthy foods.

In the United States, Novo Nordisk charges about $1,000 for a month's supply of Ozempic, and Eli Lilly charges a similar amount for Mounjaro. Prices for a month's supply of different GLP-1 drugs range from $936 to $1,349 before insurance coverage, according to the Peterson-KFF Health System Tracker. Medicare spending for three popular diabetes and weight loss drugs — Ozempic, Rybelsus, and Mounjaro — reached $5.7 billion in 2022, up from $57 million in 2018, according to research by KFF.

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The “outrageously high” price has “the potential to bankrupt Medicare, , and our entire health care system,” Sen. Bernie Sanders (I-Vt.), who chairs the U.S. Senate Committee on Health, Education, Labor and Pensions, wrote in a letter to Novo Nordisk in April.

The high prices also mean that not everyone who needs the drugs can get them. “They're kind of disadvantaged in multiple ways already and this is just one more way,” said Wedad Rahman, an endocrinologist with Piedmont in Conyers, Georgia. Many of Rahman's patients, including Cooper Harris, are underserved, have high-deductible health plans, or are on public assistance programs like Medicaid or Medicare.

Many drugmakers have programs that patients get started and stay on medicines for little or no cost. But those programs have not been reliable for medicines like Ozempic and Trulicity because of the supply shortages. And many insurers' requirements that patients prior authorization or first try less expensive drugs add to delays in care.

By the time many of Rahman's patients see her, their diabetes has gone unmanaged for years and they're suffering from severe complications like foot wounds or blindness. “And that's the end of the road,” Rahman said. “I have to pick something else that's more affordable and isn't as good for them.”

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GLP-1 agonists — the category of drugs that includes Ozempic, Trulicity, and Mounjaro — were first approved to treat diabetes. In the last three years, the Food and Drug Administration has approved rebranded versions of Mounjaro and Ozempic for weight loss, leading demand to skyrocket. And demand is only growing as more of the drugs' become apparent.

In March, the FDA approved the weight loss drug Wegovy, a version of Ozempic, to treat heart problems, which will likely increase demand, and spending. Up to 30 million Americans, or 9% of the U.S. population, are expected to be on a GLP-1 agonist by 2030, the financial services company J.P. Morgan estimated.

As more patients try to get prescriptions for GLP-1 agonists, drugmakers struggle to make enough doses.

Eli Lilly is urging people to avoid using its drug Mounjaro for cosmetic weight loss to ensure enough supplies for people with medical conditions. But the drugs' popularity continues to grow despite side effects such as nausea and constipation, driven by their effectiveness and celebrity endorsements. In March, Oprah Winfrey released an hourlong special on the medicines' ability to help with weight loss.

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It can seem like everyone in the world is taking this class of medication, said Jody Dushay, an assistant professor of medicine at Harvard Medical School and an endocrinologist at Beth Israel Deaconess Medical Center. “But it's kind of not as many people as you think,” she said. “There just isn't any.”

Even when the drugs are in stock, insurers are clamping down, leaving patients and health care providers to navigate a thicket of ever-changing coverage rules. State Medicaid plans vary in their coverage of the drugs for weight loss. Medicare won't cover the drugs if they are prescribed for obesity. And commercial insurers are tightening access due to the drugs' cost.

Health care providers are cobbling together care plans based on what's available and what patients can afford. For example, Cooper Harris' insurer covers Trulicity but not Ozempic, which she said she prefers because it has fewer side effects. When her pharmacy was out of Trulicity, she had to rely more on insulin instead of switching to Ozempic, Rahman said.

One day in March, Brandi Addison, an endocrinologist in Corpus Christi, Texas, had to adjust the prescriptions for all 18 of the patients she saw because of issues with drug availability and cost, she said. One patient, insured through a teacher retirement health plan with a high deductible, couldn't afford to be on a GLP-1 agonist, Addison said.

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“Until she reaches that deductible, that's just not a medication she can use,” Addison said. Instead, she put her patient on insulin, whose price is capped at a fraction of the cost of Ozempic, but which doesn't have the same benefits.

“Those patients who have a fixed income are going to be our more vulnerable patients,” Addison said.

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By: Renuka Rayasam
Title: High Price of Popular Diabetes Drugs Deprives Low-Income People of Effective Treatment
Sourced From: kffhealthnews.org/news/article/high-prices-ozempic-mounjaro-wegovy-glp1s/
Published Date: Tue, 21 May 2024 09:00:00 +0000

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Biden Leans Into Health Care, Asking Voters To Trust Him Over Trump

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Phil Galewitz, KFF Health News
Tue, 21 May 2024 09:00:00 +0000

Angling to tap into strong for the sweeping health he helped pass 14 years ago, one of President Joe Biden's latest reelection strategies is to remind voters that former tried to repeal the Affordable Care Act.

“Folks, he's coming for your health care, and we're not going to let it happen,” Biden says of Trump in a television and digital ad out this month, part of a $14 million investment in the handful of states expected to decide the presidency in November.

The new ad draws on the popularity of the ACA among independent voters and alludes to Biden's edge over Trump on health issues, which the current president hopes will propel him to victory.

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Swaying even a tiny percentage of voters could make a difference for Biden, said Kenneth Miller, an assistant professor of political science at the of Nevada-Las Vegas.

“It will be so close,” he said. “Any little thing can be a deciding factor.”

Political experts say Biden is wise to draw attention to the ACA, which ended long-standing insurance practices denying coverage to people with preexisting conditions or charging them more — a change that is “popular across the partisan divide” and benefits about half of U.S. households, said Ashley Kirzinger, KFF's associate director of public opinion and survey research.

“Framing the ACA around those protections is a very smart move,” she said.

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A new KFF survey found Biden has an edge with independent voters when it comes to health care issues.

Independents trust Biden more than Trump to ensure access to affordable health insurance (47% to 22%) and maintain protections for people with preexisting conditions (47% to 23%).

Biden holds a smaller advantage over Trump in whom independents trust more to address high health care costs (39% to 26%). The survey also found the issue isn't a slam dunk for either candidate: About a third of independent voters said they trust neither Biden nor Trump to address costs.

Democrats are fighting to extend higher subsidies for most people with ACA coverage, which were increased during the pandemic and are set to expire in 2025. They're also banking on outrage over the Supreme Court's 2022 decision striking down Roe v. Wade, and strict bans that have followed in many Republican-led states, to juice Democratic turnout.

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The stakes “could not be higher for Americans who rely on the Affordable Care Act,” Biden campaign spokesperson Michael Tyler told reporters on a call this month.

The Trump campaign did not respond to a request for comment.

At least one Democratic-aligned super PAC is also running health-related ads, on Trump's appointment of Supreme Court justices who helped overturn the constitutional right to an abortion.

Barry Burden, director of the Elections Research Center at the University of Wisconsin-Madison, said focusing on health care plays to Biden's strengths.

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“Biden has been mired by voter concerns about inflation and immigration, where are preferred,” he said. “Health care is more favorable territory where the Trump campaign does not have much of a defense to offer.”

Some recent polls have shown Trump leading in most battleground states, with voters expressing pessimism about the .

But Trump is vulnerable on health care, Miller said. He unsuccessfully tried to repeal the ACA as president and has alluded to trying again if he returns to the White House. In November, he declared “Obamacare Sucks!” on social media, and in March he said he wants to improve the law without saying how.

“These ads are an effort to shake up the agenda,” Miller said. “Biden needs more work reminding Democrat-leaning independent voters who probably voted for him in 2020 that he is the better choice.”

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Biden's ad also claims his health care policies have helped save Americans $800 a year. The Biden administration has said that's how much 13 million people buying coverage on ACA insurance marketplaces saved in 2022.

The ad's primary claim, that 100 million people would be harmed if Trump eliminated preexisting condition protections, is misleading, said Robert Speel, director of the Public Policy Initiative at Penn State Behrend. That's because many would retain the protections under their coverage, particularly those on Medicare and employer-sponsored insurance.

“The ad looks too generic to have a significant impact on the outcome of the election, though it may get through to enough of the small universe of swing voters to have at least some potential impact on who wins Pennsylvania,” Speel said.

The KFF survey of 1,243 registered voters conducted April 23-May 1 had a margin of sampling error of plus or minus 4 percentage points.

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By: Phil Galewitz, KFF Health News
Title: Biden Leans Into Health Care, Asking Voters To Trust Him Over Trump
Sourced From: kffhealthnews.org/news/article/biden-health-care-ad-buy-obamacare-aca/
Published Date: Tue, 21 May 2024 09:00:00 +0000

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