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Axios Explains: Abortion

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The U.S. faces a range of health care flashpoints — unaffordable drugs, opioids, vaping — as we debate whether to adopt universal care. For now, the Affordable Care Act is the law of the land, but Republicans want to issue it a final death blow.

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Axios Vitals

Inflation is making it harder for Americans — particularly minorities — to afford timely medical care for serious illnesses, according to a new national poll.

Why it matters: It's just one of the findings from the poll, which took up the recent consequences of inflation, particularly on minorities.

The findings suggest U.S. cities could be facing an uptick in hunger and homelessness in the next coming months if they don't prepare, said Robert Blendon, the co-director of the survey, told Axios.

"It's very striking," Blendon said. "We're in an inflationary period here and it's unusually broadly hitting minority communities even worse than everyone else."

By the numbers: The poll from NPR, The Robert Wood Johnson Foundation, and the Harvard T.H. Chan School of Public Health was conducted on a nationally representative sample of more than 4,000 adults. 

Nearly 60% of Black and Latino households and about 70% of Native American households said recent price increases caused them serious financial problems. In comparison, 36% of Asian households and 44% of White households agreed.

In the past year, 16% of Black renters, 10% of Latino renters, 21% of Native American renters say they have either been evicted or threatened with eviction. Less than 5% of Asian renters and 9% of white renters said the same.

Significant percentages of U.S. households with a member who's been seriously ill in the past year reported they were unable to get medical care for serious illnesses when needed. The proportions were: 35% Native American, 24% Black, 18% Latino, 18% white and 10% Asian. 

More than one in five Black adults (22%), one-quarter of Native American adults, 19% of Latino adults, 16% of white adults and 14% of Asian adults say they are currently having serious problems affording medical care or prescription drugs.  

Be smart: The deep racial disparities exposed during the first years of the COVID-19 don't appear to be improving in the latest phase of the pandemic — and could signal sustained societal problems.

"The gaps between Blacks and whites on getting care were the same," Blendon said.

Inflation hikes causing delayed care for minorities: poll

COVID-19

Generic drugmakers are warning that Democrats' plan to let Medicare negotiate the prices of drugs may undercut competition from lower-cost copycats, inject massive uncertainty into their market and forfeit potential long-term savings.

Why it matters: Experts say the concern about downstream effects on generics is valid and point to larger questions about whether the overriding focus on negotiating prices skews drug development over time. 

State of play: The Senate on Sunday passed a $740 billion tax, climate and health care package, making good on longstanding promises to lower the cost of prescription drugs. 

The bill gives Medicare the ability to step in and negotiate the price of older drugs that still don't have any competition. The bill sets price ceilings for those drugs.

That ends the status quo, under which drugmakers can enjoy monopoly prices for far longer than the exclusivity periods granted under the law — either while they wait for competition or while they block it through patent litigation. 

Yes, but: The generic industry is warning that rather than removing brand manufacturer’s incentive to stall competition, the bill will make it harder for competitors to gain entry and ultimately lead to higher prices over time.

Robust generic competition often lowers drug prices to a fraction of the brand drug's, driving the vast majority of demand to the cheaper alternative. 

"The bottom line is that it's competition that works," said Dan Leonard, CEO of the Association for Accessible Medicines. "At the end of the day there will be less competition if this legislation goes into effect."

And for brand drugs that would otherwise be facing this kind of revenue loss, the Medicare-set rate at a higher market share could actually be a better deal. 

"We think this potentially sets up a series of perpetual monopolies for the brand products, where sure, they're going to make less than they would under price controls, but they’re going to make a whole lot more than they would from competition," said Craig Burton, executive director of the Biosimilars Council.

The big picture: Generic drugmakers may  be less willing to enter the market, the industry argues, given the enhanced uncertainty about how profitable it is for them. Some experts warn this isn't just industry fear-mongering. 

Once multiple products are on the market, generics are generally sold at low margins. The most money to be made is by the first generic drug to come to market, which is granted 180 days of its own market exclusivity.

That drug only has to offer a discount that's significant enough to attract a large portion of the market away from the branded drug. That discount is much less — and thus more financially lucrative ­— than the discounts seen once multiple generics are on the market. 

But if the first generic is competing against a drug priced at the Medicare-negotiated rate, the math is thrown off. And most brand drugs will likely be eligible for negotiations before their patent protections end, at least according to current averages.

"The concern is if this makes it so the first generic is less certain about the benefits of challenging patents," said Ben Ippolito, a senior fellow at the American Enterprise Institute.

The other side: Even if the legislation weighs against the first generic entrant, the product can still be profitable, said Washington University law professor Rachel Sachs. 

And if drug companies could do a better job keeping generics off of the market, they’d have more incentive to be doing so under current law than under the new one.

"I would be very surprised if the government was negotiating for a 90% discount on a small molecule drug in its tenth year on the market. That would be unexpected," Sachs added. "Given that the expected results of this negotiation are smaller than that, I have a hard time understanding why generic competition would necessarily be impeded."

Be smart: This calculus could vary for different classes of drugs, as some will be much more dependent on the Medicare market than others. 

The intrigue: The biologics market for drugs made of living organisms is a much bigger wildcard, because we’re still gathering early-stage data on what happens when biosimilars come to market. 

The generic industry isn't predicting a good outcome for biosimilars.

"We're just getting going, and this legislation, we believe, could throw ice water on this nascent market," Leonard said.

Why generic drugmakers oppose Dems' drug pricing bill

They say it will lead to less competition over time.

Prescription drugs

Indiana became the first state in the country since Roe. v. Wade was overturned to approve a near-total abortion ban Friday night.

The big picture: The ban comes after the Supreme Court's decision to overturn Roe v. Wade sent the issue of abortion rights back to the states. Many Republican states have already begun taking action to ban the procedure, but Indiana is the first to pass a bill following the ruling.

Zoom in: Indiana Gov. Eric Holcomb signed the bill into law late Friday night after the Indiana House and Senate passed the bill earlier that day. 

Under the bill, abortions can be performed at hospitals or outpatient centers owned by hospitals. This means abortion clinics will lose licenses in Indiana.

Doctors who perform an illegal abortion, or fail to report them, will also lose their licenses under the new law, the Associated Press reports.

Yes, but: The ban includes some exceptions, including cases of rape, incest, if the fetus is diagnosed to be a lethal anomaly and cases to protect the life of the mother, AP reports. 

Of note: Indiana currently allows abortions up to 20 weeks post-fertilization (or 22 weeks after the mother's last menstrual period), CNN reports.

What they're saying: White House press secretary Karine Jean-Pierre said in a statement Saturday that the Indiana legislature "took a devastating step" to "eliminate women’s constitutionally-protected right to abortion."

She said the vote is "another radical step by Republican legislators to take away women’s reproductive rights and freedom, and put personal health care decisions in the hands of politicians rather than women and their doctors."

Gov. Holcomb said in the statement that he was "most proud of each Hoosier who came forward to courageously share their views in a debate that is unlikely to cease any time soon. For my part as your governor, I will continue to keep an open ear.”

Rep. John Jacob (R), who previously supported a total abortion ban, said the abortion bill wasn't strong enough, the Indy Star reports.

 "The body inside of the mom's body is not her body," he said, per the Washington Post. Let me repeat that: The body inside of the mom's body is not her body. Not her body, not her choice."

Rep. Wendy McNamara (R), who sponsored the bill, said the new legislation “makes Indiana one of the most pro-life states in the nation.”

Rep. Renee Pack (D) told the chamber she had an abortion in 1990 and she had to choose between having an abortion or continuing her military career, the Indy Star reports. 

"Sir, I am not a murderer," she said. "And my sisters are not murderers, either. We are pro-choice. That is what we are."

Sen. Mike Bohacek (R) could not finish his testimony about the bill as he spoke about protecting rape victims with disabilities.

What to watch: Eli Lilly and Co., which is one of Indiana's largest employers, said in reaction to the ban that it will be “forced to plan for more employment growth outside of our home state.”

Jon Mills, a spokesman for engine maker Cummins, which employs 10,000 people in Indiana, said in a statement to the New York Times that the law will "impact our people and impede our ability to attract and retain top talent.”

Mills told NYT that “prior to, and during the legislative process, we shared our concerns about this legislation with legislative leadership.”

Go deeper ... Where abortion has been banned now that Roe v. Wade is overturned

The abortion trigger laws that have gone into effect now that Roe v. Wade is overturned

Editor's note: This story was updated with a statement from the White House press secretary and to add quotes from Jon Mills. 

'Not her body, not her choice': Indiana legislature passes near-total abortion ban

Indiana Gov. Eric Holcomb signed the bill into law late Friday night.

Abortion rights protesters march outside the Indiana State Capitol building.

Abortion rights protesters march outside the Indiana State Capitol building. Photo: Jon Cherry/Getty Images

Indiana

Florida medical board looks to block gender-affirming treatments for minors

The board voted to approve gathering data and speaking with experts to build a standard of care for the state.

Illustration of a red circle, with the state of Florida forming a bar across it, with the transgender pride flag underneath.

Florida

The Centers for Disease Control and Prevention issued updated guidance Friday recommending that people limit their sexual partners while waiting to get vaccinated against monkeypox. 

Driving the news: While monkeypox is not considered a sexually transmitted disease, it is often transmitted through "close, sustained physical contact, which can include sexual contact," the CDC said.

Infections are overwhelmingly among men who have sex with men, data released by the CDC Friday shows.

However, anyone who has close contact with someone who is infectious is at risk, according to the World Health Organization.

Details: If a person or their partner suspects they have monkeypox, the best protection "is to avoid sex of any kind (oral, anal, vaginal) and kissing or touching each other’s bodies," the agency said.

To reduce the chances of being exposed to monkeypox if sexually active, the CDC recommends limiting the number of sex partners.

"Spaces like back rooms, saunas, sex clubs, or private and public sex parties, where intimate, often anonymous sexual contact with multiple partners occurs—are more likely to spread monkeypox," the agency said.

Condoms alone may not prevent exposure to monkeypox since the rash can occur on other parts of the body.

But, but, but: "Have virtual sex with no in-person contact," the CDC wrote.

Consider having sex with your clothes on or covering areas where the rash is present, reducing as much skin-to-skin contact as possible, the agency added as an alternative.

Context: The head of the WHO suggested last week that men who have sex with men should temporarily limit their number of sexual partners, according to the Washington Post.

The CDC guidance, however, is not as blunt and does not single out men who have sex with men. 

The big picture: The U.S. declared the monkeypox outbreak a public health emergency on Thursday.

There were 7,510 reported cases of monkeypox in the U.S. as of Friday, according to CDC data. 

That's up from less than 5,000 cases last week.

What's next: U.S. health officials said that said last week that 800,000 monkeypox vaccine doses will be made available for distribution. 

CDC: Limit sexual partners to avoid monkeypox

While monkeypox is not a sexually transmitted disease, it is often transmitted through close contact.

DC residents lined up at a monkeypox vaccination clinics on Aug. 5, 2022. Picture: Bill Clark/CQ-Roll Call, Inc via Getty Images

Monkeypox

A jury ruled that a pharmacist who refused to fill her prescription for a morning-after pill based on his "beliefs" did not discriminate, but did award her $25,000 for the emotional harm caused, NBC News reports. 

The big picture: The Supreme Court's decision to overturn Roe v. Wade earlier this summer has reignited debates over contraception and birth control.

Details: Andrea Anderson filed a lawsuit against a pharmacist, George Badeaux, claiming he violated the Minnesota Human Rights Act when he would not fill her prescription for birth control in 2019.

Badeaux, who is also a pastor, allegedly told Anderson that filling the prescription would go against his "beliefs," according to the lawsuit.

She later found a pharmacy 50 miles from her home that was willing to fill the prescription, the Washington Post reports.

Badeaux said during the trial he "wasn't seeking to interfere with what she wanted to do," but "was asking to be excused," per the Star Tribune.

What's next: Anderson, who is represented by lawyers from Gender Justice, plans to appeal the jury's verdict with the Minnesota Court of Appeal, NBC News reports.

“The jury was not deciding what the law is, they were deciding the facts of what happened here in this particular case," Gender Justice legal director Jess Braverman said in a statement.

"We will appeal this decision and won’t stop fighting until Minnesotans can get the health care they need without the interference of providers putting their own personal beliefs ahead of their legal and ethical obligations to their patients.”

Jury rules pharmacist who denied patient morning after pill did not discriminate

The jury did award the woman $25,000 for the emotional harm caused.

Plan-B, emergency contraceptive, and Take Action, another version of the contraceptive.

Plan-B, emergency contraceptive, and Take Action, another form of contraceptive. Photo: Jim Watson/AFP via Getty Images

Birth control

Monkeypox case numbers in the United Kingdom may have started to level off, British health officials said Friday.

Driving the news: Early signs show that the outbreak is plateauing in the region, with 2,859 confirmed cases reported since May, according to the UK Health Security Agency.

Go deeper: Health officials estimated last month that the outbreak was doubling in the region every two weeks, according to the Associated Press.

But in recent weeks, the number of new infections has dropped.

Analyses of the current U.K. outbreak shows that monkeypox continues to be transmitted "primarily in interconnected sexual networks of gay, bisexual, or other men who have sex with men," British health officials said.

Still, there have been a small number of women confirmed to have monkeypox, the agency said. 99% of all U.K. cases are in men, with only 22 cases identified in women.

What they're saying: "While the most recent data suggests the growth of the outbreak has slowed, we cannot be complacent," Meera Chand, director of clinical and emerging infections at the UK Health Security Agency, said.

"Be vigilant of and check yourself for monkeypox symptoms, including rashes and blisters," Chand added.

Meanwhile: The United States declared monkeypox a public health emergency just a day earlier.

The World Health Organization declared monkeypox a global emergency late last month.

Monkeypox has spread to more than 70 countries in the recent outbreak.

Go deeper ... What you need to know about the monkeypox vaccine 

1 in 5 Americans fear they'll get monkeypox

FDA considering "dose-sparing" approach to increase availability of Jynneos vaccine

U.K. officials say monkeypox cases beginning to level off

The number of new infections has dropped in recent weeks, but officials warned against complacency.

A vial containing the monkeypox vaccine is seen on July 23, 2022, in London, England. Picture: by Hollie Adams/Getty Images

The Food and Drug Administration is considering splitting doses of the Jynneos vaccine into fifths to increase supply amid the expanding monkeypox outbreak, FDA Commissioner Robert Califf said this week.

Driving the news: Under the "dose-sparing" approach, health care providers could use one vial of the vaccine to administer up to five doses without an impact on safety or efficacy, Califf said.

As the Department of Health and Human Services works with Jynneos' manufacturer to increase the availability of the vaccine, Califf said "dose-sparing" could provide a potential solution in the interim.

Between the lines: The new approach would require a different method of administration, or injection into the skin, Califf said at a briefing on Thursday. 

The Jynneos vaccine currently is administered with a subcutaneous injection, which goes into the fat layer underneath the skin.

The new "dose-sparing" approach would require intradermal administration, which goes into the dermis. The dermis lies just underneath the top layer of skin known as the epidermis. 

Califf noted that there are some advantages to this approach, such as an improved immune response to the vaccine.

What he's saying: "It's important to note that the overall safety and efficacy profile will not be sacrificed with this approach," Califf said. "Please know we've been exploring all scientifically feasible options, and we believe this could be a promising approach." 

"It's important to note that we will not be sacrificing the high-quality regulatory standards that Americans have come to expect," he added.

FDA considers "dose-sparing" to increase availability of Monkeypox vaccine

Health care providers could use one vial of the vaccine to administer up to five doses without an impact on safety or efficacy.

A vial of the Jynneos monkeypox vaccine at a pop-up vaccination clinic on August 3, 2022 in West Hollywood, California. Photo: Mario Tama/Getty Images

President Joe Biden tested positive for COVID-19 for the seventh consecutive day on Friday.

The big picture: Initially testing positive on July 22, Biden tested negative after five days of the antiviral Paxlovid treatment but has had a "rebound" COVID case since last Saturday. 

The 79-year-old president is fully vaccinated and received a second booster shot in March.

What they're saying: The president continues to feel "very well," Biden's doctor, Kevin O'Connor, wrote Friday.

"His cough has almost completely resolved," O'Connor added.

"His temperature, pulse, blood pressure, respiratory rate and oxygen saturation remain entirely normal. His lungs remain clear," O'Connor said. 

The doctor said Biden is continuing to follow "strict isolation measures," although he did speak at the Rose Garden on Friday.

For the record: The CDC says people can end their COVID isolation after five full days if they are fever-free for 24 hours without the use of fever-reducing medication and other symptoms have improved.

Biden has continued to test positive on an antigen test.

Antigen tests may remain positive for weeks to months after initial infection and may not always indicate contagiousness, according to the Centers for Disease Control and Prevention.

Be smart: "Rebound" cases of COVID-19 are possible for those who take Paxlovid, but it remains relatively rare, according to a Mayo Clinic study released in June.

"Paxlovid continues to be recommended for early stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease," the CDC said in May.

Biden tests positive for COVID for seventh day

The president has had a "rebound" case of COVID-19 since last Saturday.

President Joe Biden speaks at the White House on Aug. 5, 2022. Photo: Evan Vucci/Getty Images

Joe Biden

The United States has declared a public health emergency for monkeypox, raising awareness of the outbreak hitting more than 70 countries across the world. 

The big picture:  Two-thirds of Americans said in a survey from the Annenberg Public Policy Center that they don't think there's a vaccine for monkeypox or they aren't sure. But there is and here's what you need to know about it. 

There are two vaccines that are used to prevent monkeypox infections, per the Centers for Disease Control and Prevention.

The Jynneos vaccine, manufactured by the Danish company Bavarian Nordic, has been approved by the Food and Drug Administration to prevent monkeypox.

ACAM2000, which comes from the company Sanofi Pastuer Biologics, has been approved by the FDA for use against smallpox infection and for monkeypox under an expanded access application, the CDC said. ACAM2000 is found to have more side effects and a higher rate of adverse events. 

Both vaccines are smallpox vaccines, which are believed to be effective at preventing monkeypox. 

World Health Organization Director-General Tedros Adhanom Ghebreyesus said smallpox vaccines should not be widely used to treat monkeypox due to limited clinical trials and availability.

Worth noting: There is currently a limited supply of the Jynneos vaccine. The United States has been placing orders for the vaccine to handle the growing demand for vaccination, health officials told reporters Thursday.

The ACAM2000 has a larger supply of vaccines available, but the CDC does not recommend them for people with certain health conditions.

How many shots do the Jynneos vaccine and ACAM2000 require? 

Jynneos vaccine requires two shots. The immune response takes 14 days after the second dose, the CDC said.

ACAM2000 has one dose. It takes four weeks for the immune response to reach maximum strength, per the CDC.

Differences between Jynneos vaccine and ACAM2000

The Jynneos vaccine includes a live virus that doesn't replicate and is associated with fewer adverse effects, the CDC said. 

Health care providers are more comfortable distributing the vaccine, too, since it's given through needle injection.

The CDC says boosters are recommended every two years.

But ACAM2000 is distributed by multiple punctures, leading to potential scarring. The stainless steel needle is dipped into a reconstituted vaccine — a method often used for orthopoxvirus vaccinations, the CDC said.

The vaccine contains a virus capable of transmission to close contacts.

ACAM2000 has also been associated with side effects, like myocarditis.

Health officials recommend boosters for this vaccine every three years.

What you need to know about the monkeypox vaccine

There are currently two vaccines that are used to prevent monkeypox infections.

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