OLYMPIA, Wash. (AP) — The Washington state attorney general announced a $149.5 million settlement Wednesday with drugmaker Johnson & Johnson, more than four years after the state sued the company over its role fueling the opioid addiction crisis.

“They knew what the harm was. They did it anyway,” Attorney General Bob Ferguson told reporters Wednesday.

The attorney general’s announcement came as opioid overdose deaths more than doubled from 2019 to 2022, with 2,048 deaths recorded in 2022, according to the most recent numbers from the Washington State Department of Health.

Under the deal, the state and local governments would have to spend $123.3 million to address the opioid crisis, including on substance abuse treatment, expanded access to overdose-reversal drugs and services that support pregnant women on substances. The rest of the money would go toward litigation costs.

The harm is “left now to policymakers to grapple with,” the attorney general said, “or families and individuals who grapple in a very different way with the real tragedy of addiction.”

The settlement agreement still requires approval from a judge. If approved, the deal would send over $20 million more to respond to the opioid crisis than if the state had signed onto a national settlement in 2021 involving Johnson & Johnson, the attorney general’s office said.

Since the 2000s, drugmakers, wholesalers, pharmacy chains and consultants have agreed to pay more than $50 billion to state and local governments to settle claims that they played a part in creating the opioid crisis.

Under the agreements, most of the money is to be used to combat the nation’s addiction and overdose crisis.

Drug overdoses caused more than 1 million deaths in the U.S. from 1999 through 2021, and the majority of those involved opioids. At first, the crisis centered on prescription painkillers that gained more acceptance in the 1990s, and later heroin. Over the past decade, the death toll has reached an all-time high, and the biggest killers have been synthetic opioids such as fentanyl that are in the supply of many street drugs.

Washington state’s Democratic attorney general sued Johnson & Johnson in 2020, alleging that it helped drive the pharmaceutical industry’s expansion of prescription opioids. He also claimed that the company made a distinct mark on Washington’s opioid crisis by deceiving doctors and the public about the effectiveness of opioids for chronic pain and the risk of addiction.

The attorney general’s office noted that in 2015 the company was the largest supplier in the country of the active pharmaceutical ingredients that go into opioid drugs.

Johnson & Johnson said in a written statement Monday that Duragesic, its fentanyl patch, and its Nucynta opioid accounted for less than 1% of opioid prescriptions in the state and the U.S., adding that it has not sold prescription opioid medications in the country in years.

“The Company’s actions relating to the marketing and promotion of important prescription opioid medications were appropriate and responsible,” according to the statement.

Funds will be awarded by the end of this fiscal year, which means that the Legislature can earmark the money during the current legislative session. Half of the money will go to a state account, while the other half will go to an account for local governments, according to the attorney general’s office.

Democratic Sen. June Robinson said Wednesday that her children have lost friends to addiction and that she has known parents who have lost children in similar ways.

“The fact that these lawsuits have played out since then, they can’t unfortunately bring back the lives that we lost,” she said. “But they are bringing resources to our communities and to our state that we are able to invest in ways that will help people recover and hopefully help to prevent future addiction and future crises like the one that we’re seeing right now.”

The deal comes about two years after the nation’s three largest opioid distributors agreed to pay the state $518 million, with the vast majority being directed toward easing the addiction epidemic.

Find your latest news here at the Hemet & San Jacinto Chronicle

The post Washington state reaches a nearly $150 million settlement with Johnson & Johnson over opioid crisis appeared first on The Hemet & San Jacinto Chronicle.

Since vaccines became available last winter, they’ve gone disproportionately to white people over Black and Hispanic people. But that may be starting to change, writes Nada Hassanein in USA Today. In recent weeks, as cases have soared, more people of color received a first shot, compared to their overall population share, than white people. “It shows a glint of promise,” experts told Hassanein. In Southern states where the delta variant is raging, Black and Hispanic vaccination rates are rising particularly fast, according to Bloomberg Equality’s COVID-19 tracker — but, “overall, states are still generally lagging in vaccinating Black and Hispanic people.” Those analyses are based on government data, which are incomplete, but an NBC News poll suggests a different picture: When asked, 76% of Black respondents said they’d been vaccinated, along with 71% of Latinos and just 66% of whites.

“It appears that continued outreach and education has shifted the trend of vaccination in Black communities for the better,” writes Terrell Jermaine Starr at The Root. “This news certainly runs in stark contradiction to Republicans’ claims that Black people are refusing to get the jabs.” Fear of delta is also driving overall vaccination rates back up to an average of nearly 900,000 doses per day. Another contributor to the racial differences in vaccination rates, writes Philip Bump at The Washington Post, is ongoing vaccine hesitancy among white Republicans. In NBC’s poll, Republicans overall reported a 55% vaccination rate; it was even lower among Trump supporters and rural residents.

Mandates follow Pfizer’s approval Though full FDA approval of the Pfizer vaccine was hotly anticipated in recent months, it was still hailed as a pandemic milestone last week. The vaccine also got a new brand name, “Comirnaty,” which isn’t winning a lot of fans. We already knew the shot was safe and effective, but the approval could encourage holdouts to get the vaccination. Back in June, about three in 10 unvaccinated adults told the Kaiser Family Foundation poll that full approval would make them more likely to take the shot. That has led to estimates that 6 million to 18 million Americans might now want to be vaccinated. But the Kaiser polling data is more nuanced; a majority of those polled either didn’t know if the vaccines were fully approved, or assumed they already were. And as KFF survey research director Liz Hamel told The Washington Post, “most people have multiple reasons and concerns about getting vaccinated.” What might change more minds, writes Post reporter Dan Diamond, are the vaccine mandates by employers who feel the approval gives them legal cover. “That’s what’s going to do it,” said Dr. Robert Murphy, director of the Institute for Global Health at Northwestern University. “If they realize they’re going to lose their job, they’re going to really think twice about whether they really want to avoid the vaccine.” The approval also means that physicians could prescribe Comirnaty off-label to those eager for booster shots or to children under 12, for whom it has not yet been authorized at all. But the FDA, CDC and American Academy of Pediatrics quickly put the kibosh on the latter idea, citing uncertainty about safety and dosing in that age group. (Emergency authorization of Comirnaty for children 5 to 11 could come as early as October.)

Meanwhile, Moderna completed its own application for full FDA approval last week, and Pfizer has also begun the submission process for approval of a third, booster shot. And that booster data may convince the agency to approve the third shot as early as six months after the second one, rather than the eight months currently suggested, report Stephanie Armour and Jared S. Hopkins at The Wall Street Journal. Johnson & Johnson also joined the booster club last week with a report than a second injection, six to eight months after the first, amplified antibodies nine-fold. Vaccine researcher Dr. Dan Barouch of Harvard Medical School told CNN’s Maggie Fox, “I’m quite certain that the FDA, CDC, NIH, White House will use these data to likely justify or recommend a booster for J&J-vaccinated people.”

Hay is for horses, and so is Ivermectin

If you have roundworms, your doctor may prescribe the worm-killing drug Ivermectin. If you have a horse with a similar problem, you might give it a high-dose, animal-grade version of the same medication. But what you should not do, the FDA unequivocally stated last week, is take Ivermectin, especially the kind meant for livestock, to treat or prevent COVID-19 infection. “You are not a horse. You are not a cow,” tweeted the federal agency.

“Seriously, y’all. Stop it.”

There is a smidge of science behind the idea; scientists reported in summer 2020 that large doses of Ivermectin blocked viral replication in cells growing in a dish, and a number of clinical trials are underway, but the results are not in, writes Peter G. Lurie at STAT. Use of the drug for COVID-19 took off in Latin America last summer, and it’s now selling out in U.S. farm-supply stores, reports Sofia Andrade at Slate. The CDC announced last Thursday that Ivermectin prescriptions have skyrocketed increased 24-fold over their baseline rate since winter, while calls to poison control centers are up five-fold. CNN’s Oliver Darcy points to right-wing media personalities such as Tucker Carlson, Sean Hannity and Laura Ingraham of Fox News as the source of the dangerous misinformation about the deworming drug.

There is, however, an authorized COVID-19 treatment that’s effective, low on side effects, and free: monoclonal antibodies. But few people are getting it, report Lenny Bernstein and Laurie McGinley at The Washington Post. The reasons the pair cite include the attention focused on vaccines over treatments and a lack of access in many communities. Yet the antibodies can both prevent symptomatic infection in people who were exposed to the virus and knock down symptoms in people who are already infected. “It is absolutely the standard of care for COVID-19,” said pharmacist Erin McCreary, director of stewardship innovation at the University of Pittsburgh Medical Center.

Time may be running out for origin investigation

Three months ago, it wasn’t clear where the coronavirus came from — an animal or a lab — so President Joe Biden ordered intelligence officials to investigate further and report back in 90 days. Last week, the report came in, but it did little to clarify the virus’s path to humans. Experts told The Washington Post that a final answer could take years, but the members of a World Health Organization team investigating the origins noted in Nature, “the window of opportunity for conducting this crucial inquiry is closing fast.” That’s because antibodies against the virus are already waning in the first people infected, and because many farm animals have been culled, eliminating any evidence they might have carried.

Amber Dance | Columnist

Find your latest news here at the Hemet & San Jacinto Chronicle

The post Vaccine-makers seek booster approval while antivirals go underused appeared first on The Hemet & San Jacinto Chronicle.

WASHINGTON (AP) — Johnson & Johnson said Thursday that U.S. regulators extended the expiration date on millions of doses of its COVID-19 vaccine by six weeks.

The company said a Food and Drug Administration review concluded the shots remain safe and effective for at least 4 1/2 months. In February, the FDA originally authorized J&J’s vaccine for up to three months when stored at normal refrigeration levels.

Thursday’s announcement comes after state officials warned that many doses in storage would expire before the end of the month.

Vaccine expiration dates are based on information from drugmakers on how long the shots stay at the right strength. J&J said the FDA added six weeks based on data from ongoing studies assessing the vaccine’s stability.

The FDA has been reviewing expiration dates on all three U.S. authorized vaccines as companies have continued to test batches in the months since the shots first rolled out. The vaccines from Pfizer and Moderna, authorized in December, have a six-month shelf life.

The J&J extension will help maintain vaccine supplies even as the number of Americans getting shots has slipped. The country averaged about 800,000 new injections per day last week. That’s down from a high of nearly 2 million daily shots two months ago. Government officials and companies have turned to incentives to encourages shots, including paid time off to $1 million lottery prizes.

As vaccinations have slowed it’s become clear the U.S. is unlikely to meet President Joe Biden’s goal to have 70% of adults partially vaccinated by July 4. Roughly 64% of Americans older than 18 have had at least one dose, according to the Centers for Disease Control and Prevention.

J&J’s vaccine was highly anticipated because of its one-and-done formulation and easy-to-ship refrigeration. The shot was expected to play a key role in vaccination campaigns in rural areas and low-income countries with limited health care infrastructure.

But rival drugmakers Pfizer and Moderna, which started shipping shots months earlier, have already supplied more than enough doses to meet U.S. demand. More than 129 million Americans have been fully vaccinated with the companies’ two-dose shots. By comparison, just 11 million Americans have been vaccinated with the J&J shot. About 10 million more J&J doses have been sent to states, according to the CDC.

Use of J&J’s vaccine has been hurt by links to a rare blood clot disorder. That issue led U.S. health officials to “pause” use of the shot for an 11-day review. Officials lifted the hold in late April after concluding that the vaccine’s benefits outweighed its risks

J&J’s rollout has also been slowed by contamination problems at a Baltimore factory that helps make the shots. The facility was shuttered after an FDA inspection uncovered unsanitary conditions and other problems in April. None of the vaccines made there have been distributed.

Find your latest news here at the Hemet & San Jacinto Chronicle

The post US extends expiration dates for J&J COVID vaccine by 6 weeks appeared first on The Hemet & San Jacinto Chronicle.

WASHINGTON (AP) — The Supreme Court is leaving in place a $2 billion verdict in favor of women who claim they developed ovarian cancer from using Johnson & Johnson talc products.

The justices did not comment Tuesday in rejecting Johnson & Johnson’s appeal. The company argued that it was not treated fairly in facing one trial involving 22 cancer sufferers who came from 12 states and different backgrounds.

A Missouri jury initially awarded the women $4.7 billion, but a state appeals court dropped two women from the suit and reduced the award to $2 billion. The jury found that the company’s talc products contain asbestos and asbestos-laced talc can cause ovarian cancer. The company disputes both points.

Johnson & Johnson, which is based in New Brunswick, New Jersey, has stopped selling its iconic talc-based Johnson’s Baby Powder in the U.S. and Canada, though it remains on the market elsewhere.

But the company faces thousands of lawsuits from women who claim asbestos in the powder caused their cancer. Talc is a mineral similar in structure to asbestos, which is known to cause cancer, and they are sometimes obtained from the same mines. The cosmetics industry in 1976 agreed to make sure its talc products do not contain detectable amounts of asbestos.

The lead attorney for the women during the trial, Mark Lanier, praised the court’s refusal to hear Johnson & Johnson’s appeal. “This decision sends a clear message to the rich and powerful: You will be held to account when you cause grievous harm under our system of equal justice under law,” Lanier said.

Justices Samuel Alito and Brett Kavanaugh took no part in the court’s action. Alito owns $15,000 to $50,000 in Johnson & Johnson stock. Kavanaugh’s father headed the trade association that lobbied against labeling talc a carcinogen and including a warning label on talc products.

Ethicists contacted by The Associated Press said they did not think E. Edward Kavanaugh’s role required his son to step aside from the case.

Find your latest news here at the Hemet & San Jacinto Chronicle

The post Justices reject Johnson & Johnson appeal of $2B talc verdict appeared first on The Hemet & San Jacinto Chronicle.

WASHINGTON (AP) — Johnson & Johnson is asking for Supreme Court review of a $2 billion verdict in favor of women who claim they developed ovarian cancer from using the company’s talc products.

The case features an array of high-profile attorneys, some in unusual alliances, including former independent counsel Kenneth Starr, who is representing the women who sued Johnson & Johnson. The nation’s largest business groups are backing the company, and a justice’s father also makes an appearance because of his long association with the trade group for cosmetics and personal care products.

The court could say as soon as Tuesday whether it will get involved.

At the root, Johnson & Johnson argues that the company didn’t get a fair shake in a trial in state court in Missouri that resulted in an initial $4.7 billion verdict in favor of 22 women who used talc products and developed ovarian cancer.

A state appeals court cut more than half the money out of the verdict and eliminated two of the plaintiffs but otherwise upheld the outcome in a trial in which lawyers for both sides presented dueling expert testimony about whether the company’s talc products contain asbestos and asbestos-laced talc can cause ovarian cancer.

The jury found for the women on both points, after which Judge Rex M. Burlison wrote that evidence at the trial showed “particularly reprehensible conduct on the part of Defendants.”

The evidence, Burlison wrote, included that the company knew there was asbestos in products aimed at mothers and babies, knew of the potential harm and “misrepresented the safety of these products for decades.”

Nine of the women have died from ovarian cancer, lawyers for the plaintiffs said

Johnson & Johnson denies that its talc products cause cancer and it called the verdict in the Missouri trial “at odds with decades of independent scientific evaluations confirming Johnson’s Baby Powder is safe, is not contaminated by asbestos and does not cause cancer.” The company also is the maker of one of three COVID-19 vaccines approved for use in the United States.

Health concerns about talcum powders have prompted thousands of U.S. lawsuits by women who claim asbestos in the powder caused their cancer. Talc is a mineral similar in structure to asbestos, which is known to cause cancer, and they are sometimes obtained from the same mines. The cosmetics industry in 1976 agreed to make sure its talc products do not contain detectable amounts of asbestos.

Last year, a U.S. government-led analysis of 250,000 women found no strong evidence linking baby powder with ovarian cancer in the largest analysis to look at the question, though the study’s lead author called the results “very ambiguous.”

The findings were called “overall reassuring” in an editorial published with the study in January 2020 in the Journal of the American Medical Association. The study wasn’t definitive but more conclusive research probably isn’t feasible because a dwindling number of women use powder for personal hygiene, the editorial said.

A few months later, the company announced it would stop selling its iconic talc-based Johnson’s Baby Powder in the U.S. and Canada, citing declining demand driven by what it called misinformation about health concerns.

The disputed link between cancer and talc is not really a part of the high court case. Instead, the company said it should have not been forced to defend itself in one trial against claims by women from 12 states, differing backgrounds and with varying histories of using Johnson & Johnson products containing talc.

The $1.6 billion in punitive damages is out of line and should be reduced, the company also argued in a brief that was written by Neal Katyal, a Washington lawyer who aligns with progressive causes and also represents corporate clients. Katyal, who was the acting top Supreme Court lawyer for a time in the Obama administration, declined an on-the-record interview.

The U.S. Chamber of Commerce and trade associations for manufacturers, insurers and the pharmaceutical industry are among the business organizations backing Johnson & Johnson’s appeal.

Tiger Joyce, president of the American Tort Reform Association, pointed to how long it took the trial judge to read the jury its instructions as an indication of how unfair the trial was to Johnson & Johnson.

“When a defendant is facing a case where it takes over five hours for the judge to read the jury instructions to the jury, you just have to ask yourself what are we doing here,” said Joyce, whose group generally backs limits on liability lawsuits.

Starr said in an interview with The Associated Press that none of Johnson & Johnson’s legal arguments is worth the court’s time. “As the jury found and as every judge to review this six-week trial record has concluded, Johnson & Johnson’s conduct over decades was reprehensible,” Starr said.

In addition to Starr, other members of the women’s legal team are former Attorney General John Ashcroft and Washington lawyers David Frederick and Tom Goldstein, frequent advocates before the Supreme Court.

Justice Brett Kavanaugh worked for Starr when he investigated the affair between President Bill Clinton and Monica Lewinsky, which led to Clinton’s impeachment.

Another name that pops up in some documents in the case is E. Edward Kavanaugh, who was the longtime president of the Cosmetic, Toiletry and Fragrance Association and is the justice’s father.

Kavanaugh’s group fought efforts to list talc as a carcinogen or attach warning labels to talc products. Kavanaugh is retired and the group now is called the Personal Care Products Council.

Ethicists contacted by the AP said they haven’t seen anything that would warrant the justice having to step aside from the case.

Already, one justice almost certainly won’t take part. Justice Samuel Alito reported last year that he owned $15,000 to $50,000 in Johnson & Johnson stock. Federal law prohibits judges from sitting on cases in which they have financial interest.

Find your latest news here at the Hemet & San Jacinto Chronicle

The post Johnson & Johnson asks high court to void $2B talc verdict appeared first on The Hemet & San Jacinto Chronicle.

WASHINGTON (AP) — President Joe Biden said Monday that the U.S. will share an additional 20 million doses of COVID-19 vaccines with the world in the coming six weeks as domestic demand for shots drops and global disparities in distribution have grown more evident.

The doses will come from existing production of Pfizer, Moderna or Johnson & Johnson vaccine stocks, marking the first time that U.S.-controlled doses of vaccines authorized for use in the country will be shared overseas. It will boost the global vaccine sharing commitment from the U.S. to 80 million.

“We know America will never be fully safe until the pandemic that’s raging globally is under control,” Biden said at the White House.

The announcement comes on top of the Biden’s administration’s prior commitment to share about 60 million doses of the AstraZeneca vaccine, which is not yet authorized for use in the U.S., by the end of June. The AstraZeneca doses will be available to ship once they clear a safety review by the Food and Drug Administration.

Biden also tapped COVID-19 coordinator Jeff Zients to lead the administration’s efforts to share doses with the world.

“Our nation’s going to be the arsenal of vaccines for the rest of the world,” Biden said. He added that, compared to other countries like Russia and China that have sought to leverage their domestically produced doses, “we will not use our vaccines to secure favors from other countries.”

The Biden administration hasn’t yet said how the new commitment of vaccines will be shared or which countries will receive them.

To date, the U.S. has shared about 4.5 million doses of AstraZeneca vaccine with Canada and Mexico. Additional doses of the Pfizer vaccine manufactured in the U.S. have begun to be exported as the company has met its initial contract commitments to the federal government.

The U.S. has faced growing pressure to share more of its vaccine stockpile with the world as interest in vaccines has waned domestically.

“While wealthy countries continue ramping up vaccinations, less than 1 percent of COVID-19 vaccine doses globally have been administered to people in low-income countries,” said Tom Hart the acting CEO of the ONE Campaign. “The sooner the US and other wealthy countries develop a coordinated strategy for sharing vaccine doses with the world’s most vulnerable, the faster we will end the global pandemic for all.”

More than 157 million Americans have received at least one dose of a COVID-19 vaccine, and 123 million are full vaccinated against the virus. Biden hopes the U.S. will have 160 million people fully vaccinated by July Fourth.

Globally, more than 3.3 million people are confirmed to have died from the coronavirus. The U.S. has seen the largest confirmed loss of life from COVID-19, at more than 586,000 people.

Find your latest news here at the Hemet & San Jacinto Chronicle

The post Biden boosting world vaccine sharing commitment to 80M doses appeared first on The Hemet & San Jacinto Chronicle.

New York City Mayor Bill de Blasio recently announced his plans to offer shots to tourists. Once approved, mobile vans with Johnson & Johnson vaccine will be placed at famous sights: The Empire State Building, Times Square, Brooklyn Bridge Park, the High Line and Central Park.

But isn’t it too early to invite tourists who might quickly spread COVID-19, including new and more virus variants? This question is especially relevant to travelers who come from abroad. Since April, no tourists who visit New York have been required to undergo coronavirus testing or be quarantined upon arrival.

But it’s not as risky as it might seem. The federal government is still banning entry by residents of countries with a high number of coronavirus cases, like India, Brazil, Iran, England and more than 20 other European countries. And even if the country is not on the Centers for Disease Control and Prevention blacklist, its citizens must get tested three days before their flight and show a negative result before boarding. Those requirements and the fact that tourists are going to get vaccinated shortly after their arrival raise hopes that this idea won’t lead to an increase in COVID-19 cases.

With COVID-19 cases and deaths continuing to drop in the Big Apple, the city is getting ready to lift most pandemic restrictions beginning May 19. Although one of the biggest tourist attractions, Broadway shows, will not resume until September, visitors can access many well-known sights for free after being vaccinated. For example, post-vaccination treats include free tickets to Mets and Yankees games and free tickets to the American Museum of Natural History.

New York is not the only state that wants to support its suffering tourism industry by offering the vaccine to visitors. Half of U.S. states do not require American citizenship or residency for vaccinations. The most popular destination for vaccine tourists so far is Texas. For the states it is an opportunity to boost the economy: Tourists, especially those who are going to receive two doses of a vaccine, will have to spend thousands of dollars coming to the U.S. and staying at hotels for weeks.

There is an evident interest in that sort of vacation among citizens of countries where shots are less accessible, such as Mexico, Canada and Thailand. Travel agencies are already offering package tours to the U.S. that include COVID-19 shots.

One other vaccine-producing country that welcomes tourists coming for jabs is Russia. However, tours are organized only for those who have Russian passports. So the offer is available basically for Russians who live abroad. Officials explain that their priority is to inoculate Russian citizens.

Should the U.S. also keep the vaccine only for its own citizens? So far, 35% of the U.S. population has been fully vaccinated, and around 60% received one dose. Researchers say the people who most wanted to get vaccinated have done so. Now officials are trying to make vaccination desirable for those who are hesitant. Domestic traveling — with perks for the newly vaccinated — can be one of the ways to promote vaccines. Inviting foreign visitors to be vaccinated is also beneficial; apart from the revenue it will bring, it is a chance for the U.S. to help other countries and make vaccines accessible to the rest of the world. But there’s a downside we shouldn’t ignore. Given that this opportunity will be available only for wealthy tourists, it might expand the gap between rich nations or wealthy individuals, who can afford to travel to the U.S. for a shot, and poor regions or poor residents in developed countries. And, obviously, supporting vaccine tourism will not have the same effect as exporting more vaccines to India and other countries, where citizens desperately need them.

YANA PASHAEVA | Contributed

Find your latest news here at the Hemet & San Jacinto Chronicle

The post Welcome to America — for a COVID-19 vaccine shot appeared first on The Hemet & San Jacinto Chronicle.