Texas law requiring some drunken drivers to pay child support goes into effect

 Texas drunken drivers who kill a child’s parent or guardian in a crash are now liable to pay child support, according to legislation that went into effect Friday.

Texas House Bill 393, also known as Bentley’s Law, was first filed on Nov. 14 of last year. Texas Gov. Greg Abbott signed the bill on June 2.

“Any time a parent passes is tragic, but a death at the hands of a drunk driver is especially heinous,” the Republican governor wrote on X, formerly known as Twitter.

“I was proud to sign HB 393 into law this year to require offenders to pay child support for the children of their victims.”

According to the law, intoxicated manslaughter culprits are only on the hook until the child turns 18 years old or finishes high school. 

“[T]he court shall determine an amount to be paid monthly for the support of the child until the child reaches 18 years of age or has graduated from high school, whichever is later,” the text reads.

The amount of child support depends on multiple factors, including the child’s educational needs, medical needs and any reasonable childcare costs. The standard of living that the child is used to is also considered.

Anyone who is unable to make payments due to incarceration may be eligible for a payment plan.

“[T]he defendant shall begin payments not later than the first anniversary of the date of the defendant’s release from the facility,” the law states.

“The defendant may enter into a payment plan to address any arrearage that exists on the date of the defendant’s release.”

Texas Governor Greg Abbott signs new law that would mandate drunken drivers who kill a child’s parent or guardian in a crash to pay child support.

REUTERS
“The defendant must pay all arrearages regardless of whether the restitution payments were scheduled to terminate while the defendant was confined or imprisoned in the correctional facility.” the law adds.

https://nypost.com/2023/09/03/texas-law-requiring-some-drunken-drivers-to-pay-child-support-goes-into-effect/

Health tech news: Lawmakers call on FDA to issue stricter bone graft guidance

 A bipartisan group of Michigan lawmakers sent the FDA a letter yesterday calling for stronger guidance in testing bone tissue products and screening donors. The statement comes as the CDC works to control a U.S. tuberculosis outbreak that spread via infected bone material used by dentists and orthopedic surgeons. There have been two deaths and at least 36 exposures. It’s the second tuberculosis outbreak linked to the biomaterial device company, Aziyo Biologics.

There’s no commercially available tuberculosis test for bone tissue. Even if that test existed, neither the FDA nor the American Association of Tissue Banks require companies to test their donor materials for TB.

Sens. Gary Peters and Debbie Stabenow, along with Reps. John Moolenaar and Debbie Dingell, told the FDA they had been contacted by a physician at the Michigan Medicine hospital system whose patient died of TB in August after being implanted with the material. The lawmakers urged the FDA to adopt the American Association of Tissue Banks’ recent, more stringent standards for donor screening.

“We urge the FDA to consider these recommendations and promptly

issue guidance or regulations based on sound science to protect patients and increase accountability for human tissue transplant products,” they wrote.

What’s going on at Biofourmis?

Once valued at $1.3  billion, Biofourmis appears to be in a bit of trouble. Yesterday, I reported that the company’s founder and CEO Kuldeep Singh Rajput quietly stepped down from his role without having a successor in place, just a month after his company laid off 120 people. Ben Wanamaker — formerly of Humana, Aetna, and Walmart has joined the Biofourmis board — and will oversee the company’s leadership until a new chief executive is found.

Over the years,  Biofourmis has raised close to half a billion dollars and dabbled in several flavors of tech-enabled care delivery for health systems and digital support for biopharma companies. This summer, the company issued a press release bragging about all its progress over the last year, at the very same time that the layoffs were happening. Now the CEO is out — what’s going on?

Read more here. 

Maybe don’t ask Alexa for help with CPR 

If your dinner companion chokes and is in sudden need of CPR, do not ask Siri or any other voice assistant for help. Your phone is your best friend: Use it to call 911.

That’s the takeaway from a new study in which researchers asked four commercial voice assistants as well as OpenAI‘s ChatGPT a series of different questions about CPR. According to the researchers, the assistants performed poorly, answering with  responses about CPR 59% of the time. In several cases, assistants simply said they didn’t know. (Microsoft‘s Cortana twice answered “words fail me” — yikes.) ChatGPT, unsurprisingly, performed much better, but it is unable to speak its responses.

The researchers suggest that voice assistants ought to be programmed to offer CPR instructions using  designated CPR commands. Sure! I bet the developers at tech giants are working overtime to get the feature out in time for the holiday shopping season.

The latest breakthrough devices

As we close out summer, it’s time for an update to our Breakthrough Devices Tracker. The FDA’s breakthrough devices program is designed for companies working on novel, potentially life saving therapies. Because these devices are thought to have more promise, the agency can “live with more uncertainty” about their effectiveness, as an FDA cardiovascular official said at a panel last week. So while the breakthrough program is helpful for companies, its value to patients is less clear.Here are some notable devices that have snagged the breakthrough designation since June:

• T2 Biosciences announced breakthrough status for its rapid test of the fungal pathogen candida auris.
• Singapore-based Mirxes announced its designation for a gastric cancer blood test.
• Fasikl announced breakthrough status for two of its products: a nerve-computer interface that allows amputees or paralyzed patients to control a robotic arm or computer, and a neurostimulation device to relieve chronic pain in amputees.
• Anumana earned the designation for an AI algorithm to help detect cardiac amyloidosis, an often undiagnosed cause of heart failure.

Industry news

• Users of Oura smart rings can now share reports about their sleep with their therapists on virtual mental health platform Talkspace. “For both companies, we see this partnership as a way of enhancing our offering to current members and potentially introducing ourselves up to each other’s’ respective audiences,” Katelyn Watson, chief marketing officer at Talkspace, told me over email.
• Hospital giant HCA and Google Cloud announced a partnership aimed at using generative AI “to improve workflows on time-consuming tasks, such as clinical documentation.”
• Drug discounts platform GoodRx announced a new feature that will allow providers to check how much drugs would cost patients by comparing GoodRx discounts, manufacturer coupons, and insurance-covered prices in one place.

What we’re reading

• Disney, The New York Times and CNN are among a dozen major media companies blocking access to ChatGPT as they wage a cold war on A.I., CNN
• New law to implement telehealth medicine inside ambulances, KCBD
• The A.I. surveillance tool DHS uses to detect ‘sentiment and emotion’, 404
• Large language models aren’t people. Let’s stop testing them as if they were, MIT Technology Review

https://www.statnews.com/2023/08/31/fda-bone-graft-health-tech/

A Tragic Day for American Patients

 Today is a somber day for patients. The Biden administration is about to announce the first 10 drugs that will be subject to price controls under the disingenuously named Inflation Reduction Act (IRA). This misguided policy will restrict patient access to existing medicines and stifle the development of new ones.

While this year-old law's supporters frame it as a blow against Big Pharma's profits, the IRA's real victims will be everyday people. Decades of experience prove that government-imposed price controls eventually reduce incentives for innovation and inhibit patients' access to drugs. To witness the ill effects of government price-setting schemes, look no further than the multitude of drugs available to Americans that foreign bureaucrats delay or deny to patients in other countries.

The dismal equation is simple: Medicare price controls will reduce revenues for pharmaceutical companies. This, in turn, will limit their investment in new treatments. With less incentive to devote the billions of dollars required to develop new medicines, pharmaceutical companies will divert money and manpower away from high-risk research areas like Alzheimer's, cancer, and heart disease. The resulting decline in new treatments will devastate patients hoping for medical progress and loved ones seeking care and comfort for their kids, parents, grandparents, and others they cherish.

We must not forget that bringing a new drug to market requires immense investment, time, and risk. Each new medicine averages almost $3 billion in research outlays and 10 to 15 years of development in cutting-edge laboratories. This steep cost stems from both these direct expenses and the reality that only one in 10 drug candidates that enter clinical trials win FDA approval. The other nine fail. Investors wager capital on microscopic strands of unproven molecules because the profit potential of a successful drug justifies these huge rolls of the dice.

Unfortunately, price controls disrupt this risk-reward calculus. This heavy-handed government intervention undermines the chances of recouping development costs and earning any profit beyond that. This makes investing in new medicines far less attractive. With lower potential returns, revolutionary treatments for diseases like Alzheimer's and cancer will remain mirages, always just beyond the hazy horizon.

This is especially true for small-molecule drugs, since the IRA's controls can kick in just nine years after FDA approval instead of 13 for biologics. Of all the IRA's misguided policies, this may be the most glaring and worrisome. Half of a drug's lifetime revenue generally comes after its ninth year on the market. By imposing these controls, the government has made new small-molecule drugs potentially half as valuable -- a surefire way to discourage investment in new research in small-molecule treatments, which normally come in the form of easy-to-use pills rather than injections or infusions that require patients to travel to a clinic.

And the damage won't stop at the 10 drugs in the White House's immediate crosshairs. Next year, the government will select 15 additional medicines for price controls. Then another 15 the year after that. Then 20 the year after that.

By the end of the decade, virtually every top-selling medicine that isn't a recent release will be subject to price controls.  

These European-style price controls ignore the vastly superior results of America's free-market system. Simply put, no other nation comes close to this country's level of biopharmaceutical innovation. The U.S. developed over half of all new medicines launched worldwide between 2011 and 2020, despite being home to just 4 percent of Earth's population.

Why undermine this successful system? America leads the world in drug development because companies enjoy financial incentives to take risks. Rather than empower Washington bureaucrats, better solutions could limit costs without jeopardizing innovation.

Eliminating barriers that generic and biosimilar versions of brand-name drugs face before they enter the market would increase competition and reduce prices. Reforming FDA regulations to accelerate approval for certain drugs also would speed less expensive medicines to patients.

Unfortunately, the Inflation Reduction Act takes the opposite approach and puts Uncle Sam firmly in command. Americans will pay for this short-sighted mistake through diseases uncured and lives unimproved. By annihilating pharmaceutical innovation, the IRA's intrusions dash all hope for our aging parents struggling with Alzheimer's, our children fighting cancer, and our friends facing debilitating diseases. Every American will suffer from slower medical progress and fewer treatment options. Washington's price controls will cast a long and dark shadow over the future of medicine and place promising therapies just around an ever-receding corner.

Peter Pitts is a former associate commissioner of the Food and Drug Administration and President of the Center for Medicine in the Public Interest.

https://townhall.com/columnists/peterpitts/2023/08/29/a-tragic-day-for-american-patients-n2627684

Biden’s Border Crisis Fuels Massive Spike In Retail Crime

 As retailers reported their quarterly earnings this month, a phrase that kept cropping up is one you probably never heard before – “organized retail crime.” It has spiked enough that it’s eating into profits.

Turns out that, by throwing open the southern border, President Joe Biden has created a booming business for Mexican cartels ripping off U.S. retailers – although you’d never know it based on the media blackout of this trend.

Target, Dollar Tree, Foot Locker, Dick’s Sporting Goods, Nordstrom, and others recently disclosed that organized retail crime – or ORC for short – is hitting their bottom lines.

Dick’s Chief Financial Officer Navdeep Gupta said that the sports retailer lowered its profit outlook for the year in part because “the number of incidents and the organized retail crime impact came in significantly higher than we anticipated.”

Dollar Tree said it is keeping more of its items in locked cases or removing them altogether as organized theft climbs

Just last week, 50 criminals swarmed a Los Angeles mall and made off with $300,000 worth of stolen goods. A news report suggests that they were following orders from organized crime or gang members.

“There’s no doubt that there’s a lot of … criminal organizations behind this. Some of it involves gang members; some of it involves people that are what you would identify as professional retail thieves,” Deputy Los Angeles Police Chief Alan Hamilton told NBC News on Sunday. “It runs the gamut, and there is a black market for purchasing these items, unfortunately. … The same people [are] then turning around and committing these acts again, over and over again.”

The National Retail Federation says ORC cost retailers close to $100 billion in 2021 – a significant increase from the year before – and that money eventually comes out of consumers’ pockets.

The costs don’t end there. States are spending hundreds of millions of taxpayer dollars setting up special task forces to fight ORC. “California alone has invested more than $241.4 million over the past year bolstering law enforcement efforts to investigate and prevent organized retail theft,” reports Reuters. Then there’s also the estimated $15 billion estimated lost tax revenue.

In other words, it’s a huge problem, and getting worse.

Why the sudden explosion in organized retail crime? When it covers this issue at all, the mainstream press usually just throws up its hands, or says retailers are exaggerating the problem.

But could it have anything to do with the fact that Biden opened the border and let millions of illegal immigrants flood into the country?

Immigration and Customs Enforcement  (ICE) sees a connection. In a statement released last June, it said: “Recent investigations have also identified organized retail crime schemes exploiting undocumented migrants forced to steal goods to pay back ‘coyotes’ who smuggle them across international borders.”

In another report, ICE says that:

Boosters are often undocumented immigrants, labor trafficked into the United States and working off a debt, or individuals suffering from some form of addiction. The boosters are the thieves on the ground that steal (boost) the products. They typically have a list of merchandise to steal from their crew boss and may hit numerous stores in one day. The boosters will likely be paid in cash or through anonymous/encrypted peer-to-peer payment apps.

By June of last year, the problem had grown so severe that ICE announced an effort to crack down on this migrant-fueled crime wave.

“It’s a crime that’s occurring out in our streets that’s becoming large enough where the federal government is announcing its involvement,” Thomas Welch, chief for ICE Homeland Security Investigation’s financial crimes unit in Washington, D.C., said at a news conference last year.

The connection between illegal immigrants and organized retail crime isn’t exactly new. The FBI told Congress back in 2009 about immigrants’ role, informing lawmakers that: “organized retail theft groups … utilize low-level boosters – those who actually steal the merchandise – and higher-level fencers, who frequently coordinate booster thefts. Often these boosters are illegal immigrants working off a debt or individuals suffering from some form of addiction. If these low-level boosters are removed from the criminal enterprise others will simply step in to take their place.”

Is it so hard to believe that there’s a connection between the tsunami of illegal immigrants under Biden and the rise in this form of organized crime?

Coverage of this connection has been sparse.

The Washington Examiner, one of the only outlets to cover this angle, reported this week that “Mexican cartels are behind the spike in organized retail crime and are deeply entrenched in every level of the process, according to the federal government’s chief investigative agency.”

It goes on to explain that:

These retail crimes are perpetrated by people who work as part of a crime ring run by cartels. In recent years, cartels have gone from illicit drug manufacturing and smuggling, human smuggling and trafficking, and illegal firearm smuggling to commandeering crime in the retail environment.

Cartels are involved in every level of retail crime, from in-store theft and listing items in online marketplaces to shipping stolen merchandise worldwide and using U.S. financial institutions to hold their profits.

This is a huge, hidden tax on Americans, who are paying in the form of higher prices and a loss of safety and security. It’s getting worse, courtesy of our current president.

And to its undying shame, corrupt Big Media are ignoring this story, both because it involves the border crisis they pretend doesn’t exist and because it reflects badly on Biden.

https://issuesinsights.com/2023/09/01/bidens-border-crisis-fuels-massive-spike-in-retail-crime/

Federal appeals court revives lawsuit against FDA over COVID-19 ivermectin messaging

 A federal appeals court ruled Friday that a lawsuit against the Food and Drug Administration (FDA) over its campaign against the use of ivermectin to treat COVID-19 can continue, reversing a lower court decision.

Three doctors sued the FDA last year claiming that the agency’s anti-ivermectin campaign went too far, overstepping its authority and acting more as a medical body than a regulator.

A district court ruled that the suit could not continue, but the 5th Circuit Appeals Court revived the doctors’ hope in its Friday ruling, sending the case back to lower court where it will be reconsidered.

“FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise,” Judge Don Willett wrote for the appeals court. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”

The FDA’s campaign, which included viral signs reading “You are not a horse,” emphasized agency recommendations that ivermectin — an anti-parasite medication often used for horses but sometimes prescribed to humans — should not be used to treat COVID-19.

“Although FDA has approved ivermectin for certain uses in humans and animals, it has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use,” the agency’s recommendations stated.

Some fringe conservative circles hailed the drug as a miracle cure, while others were hospitalized and some died from its side effects.

A review of 14 studies on ivermectin use in 2021 found little significant evidence supporting its use, noting that among the studies, “few are considered high quality.”

“It must be acknowledged that some of these studies were possibly intentionally designed to yield predetermined findings,” researchers wrote.

The World Health Organization and the National Institutes of Health are among the bodies which have also recommended against ivermectin use for COVID treatment. The drug’s manufacturer, Merck, said there is “no meaningful evidence” that is is effective at treating the disease.

The three doctors said their reputations were harmed by the FDA campaign because they promoted ivermectin use. One doctor was suspended from a hospital, while another was fired from a medical school.“This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA,” the doctors’ attorney Jared Kelson said in a statement. “It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here.”

Mary Talley Bowen, one of the plaintiffs, celebrated the ruling Friday.

“A small win, or at least a step forward, in a monumental battle to protect the doctor-patient relationship from government tyranny,” she said. “ONWARD!”

https://thehill.com/regulation/court-battles/4184259-federal-appeals-court-revives-lawsuit-against-fda-over-covid-19-ivermectin-messaging/

Yes, late-term abortions are real, and they happen every day

 There is a concerted effort from the abortion lobby and its allies in media to convince Americans that there is no such thing as late term abortion. It isn’t true.

Just recently, Planned Parenthood President Alexis McGill claimed that: “Like Nessie and Bigfoot, the term ‘late-term abortion’ is completely made up. It’s anti-abortion propaganda with no basis in medicine, intended to confuse people.” 

Likewise, former White House Press Secretary Jen Psaki echoed that “no one supports abortion up until birth,” and then later defended this claim on her MSNBC show: “This claim that Democrats support abortion up until the moment of birth is entirely misleading,” she said.

But the truth is that 10,000 babies’ lives are lost every year to late-term abortions, the majority of which take place for elective reasons.     

These denials of the harsh reality reveal one positive thing — the deniers at least recognize that support for limitless abortion is unpopular. One poll shows that 70 percent of Americans believe that abortion should be limited at least after 12 to 15 weeks into pregnancy, and other polls demonstrate the same consensus on the issue.

Throughout my time as a leader in the pro-life movement, I have worked to educate pro-abortion rights leaders about the beauty of life and the truth about abortion so that we can overcome the differences dividing us.   

Psaki’s claim, that “no one supports abortion up until birth,” has also been roundly debunked by the many members of her own party who refuse to name a single limit on abortion they would support. This includes Sens. Ben Cardin (D-Md.), Mark Kelly (D-Ariz.) and John Fetterman (D-Pa.); former gubernatorial candidate Stacey Abrams (D-Ga.); and former Reps. Beto O’Rourke (D-Tex.) and Tim Ryan (D-Ohio), among many others.  

As a Virginia resident, I will never forget the day when our former Governor Ralph Northam (D) admitted publicly that he believed it permissible, both as a physician and as governor, to allow survivors of botched abortions to be left to die even after they were born alive.  

Such heartlessness is not merely rhetorical. That same year, U.S. Senate Democratic leaders killed a bill that would have required medical care for babies who survive abortions. 

I could barely believe it then, and I also can’t believe that today, seven states and Washington D.C. have no limits on abortion whatsoever. The result of such policies was on display about a year ago when pro-life advocates discovered the mutilated remains of five fully formed babies, including possible victims of illegal partial birth abortions, originating from a Washington D.C. abortion clinic.

Some in Congress and the White House have also been fighting to pass the deceptively named “Women’s Health Protection Act (WHPA),” which would allow abortion on demand, up until birth, for any reason at any time. Supporters often claim that the WHPA’s mention of “viability” constitutes a limit on late-term abortion. But “viability” can be, and in the past has been, interpreted to mean just about anything. According to the late-term abortionist Warren Hern, “the viability of a fetus is determined not by gestational age but by a woman’s willingness to carry it.”

One of Planned Parenthood’s chief medical officers, Colleen McNicholas, similarly admitted during sworn testimony before Congress that “there is no particular gestational age” for viability. “There are some pregnancies in which the fetus will never be viable,” she added. “My practice includes (abortion) through the point of viability, and as we previously discussed, that could be at any point.”  

So late-term abortion is far from a myth. Statistically, it occurs dozens of times each day. This brings me enormous grief, especially since I have spent the past decade leading an organization that works and marches to ring in a new era where Psaki’s words ring true — when “no one supports abortion up until birth.” Unfortunately, we are not there yet, even though a large majority of Americans believe that second- and third-trimester abortions should be illegal.  

The 10,000 lives lost each year to late term abortions should compel even those who do not call themselves pro-life to join us as we work to end the violence and provide women and children with the resources, love and support they need to thrive.

Jeanne Mancini is president of the March for Life

https://thehill.com/opinion/healthcare/4182865-yes-late-term-abortions-are-real-and-they-happen-every-day/

France to ban disposable e-cigarettes, PM says

 France plans to ban disposable electronic cigarettes, French Prime Minister Elisabeth Borne said on radio station RTL on Sunday.

“It’s an important public health issue,” said Borne, adding that the government is drawing up plans for a national programme to fight tobacco use that she said was responsible for 75,000 deaths a year in France.

So-called "puff" devices generate habits among young people that can lead to tobacco addiction, she added.

However, the government does not plan to raise taxes on tobacco next year after an increase this year, the prime minister said.

French President Emmanuel Macron in 2021 set out ambitious plans to tackle tobacco and alcohol, pledging more smoking-free areas and aiming to make all 20-year-olds tobacco-free by 2030.

https://news.yahoo.com/france-ban-disposable-e-cigarettes-101239047.html