DeSantis Changes Mind—Allows Florida To Buy Covid Vaccines For Kids 5 And Younger

 Florida has joined all 49 other states ordering Covid vaccines through a federal program for children age 5 and younger, according to multiple reports, after Governor Ron DeSantis (R) faced immense criticism for making the state the sole holdout in buying vaccines.

Florida Governor Ron DeSantis (R) speaks at the Albert J. Dunlap Athletic Training Facility on the ... [+]

 DON JUAN MOORE/GETTY IMAGES

KEY FACTS

White House Press Secretary Karine Jean-Pierre told media outlets DeSantis’ decision was “an encouraging first step” after what she called “repeated failures” by the governor.

Florida missed Tuesday’s deadline to preorder vaccines, meaning shipments through the federal program likely will not arrive there until the end of the month.

A key Food and Drug Administration panel unanimously recommended approval for Pfizer-BioNTech and Moderna’s vaccines for children 5 and younger on Wednesday, with full FDA approval coming Friday and a rollout of preordered vaccines possibly taking place by next week.

DeSantis defended his decision not to preorder vaccines in a news conference on Thursday, saying his administration was “affirmatively against the Covid vaccine for young kids.”

In a statement Friday, DeSantis spokesman Bryan Griffin denied DeSantis was “reversing course,” saying the state never intended to buy shots during the preorder period.

McClatchy was first to report the news.

KEY BACKGROUND

After being vocally supportive of vaccinations during the initial rollout of shots in late 2020, DeSantis became one of the most prominent figures linked with vaccine skepticism. The governor was one of the first in the nation to ban vaccine mandates and refused to say whether he got a booster shot before his recent railings against shots for young children, falsely saying Thursday that young kids are at “zero risk of getting anything” and claiming Covid fears are stoked by media hysteria. DeSantis also appointed controversy-prone Dr. Joseph Ladapo as state surgeon general in September. Ladapo has compared the health benefits of vaccinations to eating fruits and vegetables, and announced in March the state was advising against giving Covid vaccines to healthy children. The FDA, CDC and nearly all top public health experts have stated Covid vaccines are safe and essential to ending the pandemic.

SURPRISING FACT

A poll released by the Kaiser Family Foundation last month suggested most parents of kids under 5 are not eager to get their children vaccinated against Covid. Only 18% said they planned to get their children vaccinated right away, while 38% plan to “wait a while to see how the vaccine is working for others” and 27% said they definitely won't have their kids vaccinated for Covid. Another 11% said they would only vaccinate their kids if it becomes a requirement.

https://www.forbes.com/sites/nicholasreimann/2022/06/17/desantis-changes-mind-allows-florida-to-buy-covid-vaccines-for-kids-5-and-younger-report-says/

Dem Lawmakers To Google: Abortion Search Results Shouldn’t Direct Women To ‘Fake Clinics’

 In a letter sent Friday, 21 Democratic legislators urge Alphabet, the parent company of Google, to fix what it calls “misleading” search results on abortion, following a study released earlier this week that found some Google searches for abortion information in states with so-called trigger laws direct people to crisis pregnancy centers that counsel against abortion.

Google's headquarters in Mountain View, California (Photo by David Paul Morris/Getty Images)

 GETTY IMAGES

KEY FACTS

The letter urges Alphabet to address the Center for Countering Digital Hate’s findings that in the 13 states set to outlaw abortion if Roe v. Wade is overturned, searches for “abortion clinic near me” and “abortion pill” directed people to clinics run by anti-abortion groups 37% of the time on Google Maps and 11% of the time on Google searches.

The letter, written by Sen. Mark Warner (D-Va.) and Rep. Elissa Slotkin (D-Mich.), asks Alphabet CEO Sundar Pichai to submit a plan to limit the number of search results that lead people to “anti-abortion clinics,” add disclaimers when those clinics appear in search results, and provide information on Google’s attempts to provide “accurate search results” on health care.

The lawmakers charged that a “misleading” result “undermines the integrity of Google’s search results” and can be “dangerous to women’s health.”

In a statement to Forbes, Google said any organization that advertises on its site to people seeking information on abortions must be certified through the company and show “in-ad disclosures” that “clearly state” whether they provide abortions.

SURPRISING FACT

The study also found that 28% of Google ads displayed at the top of the search results were for anti-abortion clinics.

KEY BACKGROUND

The letter comes one month after Politico published a draft decision from Supreme Court Justice Samuel Alito that would strike down the two landmark Supreme Court decisions that provide federal protection for abortions: 1973’s Roe v. Wade and 1992’s Planned Parenthood v. Casey. Alito wrote in his draft decision that “Roe was egregiously wrong from the start” and “must be overruled.” Overturning Roe would leave the legality of abortion up to individual states, including the 13 that have trigger laws to ban the procedure if Roe is overturned: Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, Utah and Wyoming. All but one of those bans – Wyoming’s – would make performing an abortion a felony punishable by prison time. Lawmakers in four more states – Georgia, Iowa, Ohio and South Carolina – have proposed bans on abortions after six weeks, if Roe is overturned.

TANGENT

Meta, the parent company behind Facebook, was reported on Wednesday to be collecting data from people who search for crisis pregnancy centers – quasi health clinics that advise women against abortions – and enabling those clinics to use Facebook data to target people online through promotions, violating its own policies.

https://www.forbes.com/sites/brianbushard/2022/06/17/democratic-lawmakers-to-google-abortion-search-results-shouldnt-direct-women-to-fake-clinics/

ADHD and ASD: What the eyes could reveal

 It's often said that 'the eyes tell it all', but no matter what their outward expression, the eyes may also be able to signal neurodevelopmental disorders such as ASD and ADHD according to new research from Flinders University and the University of South Australia.

In the first study of its kind, researchers found that recordings from the retina could identify distinct signals for both Attention Deficit Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD) providing a potential biomarker for each condition.

Using the 'electroretinogram' (ERG) -- a diagnostic test that measures the electrical activity of the retina in response to a light stimulus -- researchers found that children with ADHD showed higher overall ERG energy, whereas children with ASD showed less ERG energy.

Research optometrist at Flinders University, Dr Paul Constable, says the preliminary findings indicate promising results for improved diagnoses and treatments in the future.

"ASD and ADHD are the most common neurodevelopmental disorders diagnosed in childhood. But as they often share similar traits, making diagnoses for both conditions can be lengthy and complicated," Dr Constable says.

"Our research aims to improve this. By exploring how signals in the retina react to light stimuli, we hope to develop more accurate and earlier diagnoses for different neurodevelopmental conditions.

"Retinal signals have specific nerves that generate them, so if we can identify these differences and localise them to specific pathways that use different chemical signals that are also used in the brain, then we can show distinct differences for children with ADHD and ASD and potentially other neurodevelopmental conditions."

"This study delivers preliminary evidence for neurophysiological changes that not only differentiate both ADHD and ASD from typically developing children, but also evidence that they can be distinguished from each other based on ERG characteristics."

According to the World Health Organization, one in 100 children has ASD, with 5-8 per cent of children diagnosed with ADHD.

Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental condition characterised by being overly active, struggling to pay attention, and difficulty controlling impulsive behaviours. Autism spectrum disorder (ASD) is also a neurodevelopmental condition where children behave, communicate, interact, and learn in ways that are different from most other people.

Co-researcher and expert in human and artificial cognition at the University of South Australia, Dr Fernando Marmolejo-Ramos, says the research has potential to extend across other neurological conditions.

"Ultimately, we're looking at how the eyes can help us understand the brain," Dr Marmolejo-Ramos says.

"While further research is needed to establish abnormalities in retinal signals that are specific to these and other neurodevelopmental disorders, what we've observed so far shows that we are on the precipice of something amazing.

"It is truly a case of watching this space; as it happens, the eyes could reveal all."

This research was conducted in partnership with McGill University, University College London and the Great Ormond Street Hospital for Children.

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Story Source:

Materials provided by University of South Australia. Note: Content may be edited for style and length.

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Journal Reference:

1. Paul A. Constable, Fernando Marmolejo-Ramos, Mercedes Gauthier, Irene O. Lee, David H. Skuse, Dorothy A. Thompson. Discrete Wavelet Transform Analysis of the Electroretinogram in Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder. Frontiers in Neuroscience, 2022; 16 DOI: 10.3389/fnins.2022.890461

https://www.sciencedaily.com/releases/2022/06/220617101604.htm

Food Allergy Test Advance: Less Risk, More Useful Results

 What would you do if you believed you had a serious health issue, but the best way to find out for sure might kill you?

That's the reality for patients who wish to confirm or rule out a food allergy, says Sindy Tang, PhD, an associate professor of mechanical engineering at Stanford University in California.

And it's the reason Tang and her colleagues are developing a food allergy test that's not only safer, but also more reliable than today's tests. In a article in the journal Lab on a Chip, Tang and her colleagues outline the basis for this future test, which isolates a food allergy marker from the blood using a magnetic field.

How Today's Food Allergy Tests Fall Short

The gold standard for food allergy diagnosis is the oral food challenge. That's when the patient eats gradually increasing amounts of a problem food — say, peanuts — every 15 to 30 minutes to see if symptoms occur. This means highly allergic patients may risk anaphylaxis, an allergic reaction that causes inflammation so severe that breathing becomes restricted and blood pressure drops. Because of that, a clinical team must be at the ready with treatments like oxygen, epinephrine, or albuterol.

"The test is very accurate, but it's also potentially unsafe and even fatal in rare cases," Tang says. "That's led to many sham tests advertised online that claim to use hair samples for food tests, but those are inaccurate and potentially dangerous since they may give someone a false sense of confidence about a food they should avoid."

Less risky tests are available, such as skin-prick tests — those involve scratching a small amount of the food into a patient's arm — as well as blood tests that measure allergen-specific antibodies.

"Unfortunately, both of those are not that accurate and have high false-positive rates," Tang says. "The best method is the oral food challenge, which many patients are afraid to do, not surprisingly."

The Future of Food Allergy Testing: Faster, Safer, More Reliable

In their study, the Stanford researchers focused on a type of white blood cell known as basophils, which release histamine when triggered by allergens. By using magnetic nanoparticles that bind to some blood cells but not basophils, they were able to separate basophils from the blood with a magnetic field in just 10 minutes.

Once isolated, the basophils are exposed to potential allergens. If they react, that's a sign of an allergy.

Basophils have been isolated in labs before, but not nearly this quickly and efficiently, Tang says.

"For true basophil activation, you need the blood to be fresh, which is challenging when you have to send it to a lab," Tang says. "Being able to do this kind of test within a clinic or an in-house lab would be a big step forward."

Next Steps

While this represents an advance in basophil activation testing, more research is needed to fully develop the system for clinical use. It must be standardized, automated, and miniaturized, the researchers say.

That said, the results give hope to those with food allergies that tomorrow's gold-standard test will require only a blood sample without an emergency team standing by.

Sources

Sindy Tang, PhD, an associate professor of mechanical engineering at Stanford University, California.

Lab on a Chip:"Exponential magnetophoretic gradient for the direct isolation of basophils from whole blood in a microfluidic system."

https://www.medscape.com/viewarticle/975851

How We Treat Acute Pain Could Be Wrong

 In a surprising discovery that flies in the face of conventional medicine, McGill University researchers report that treating pain with anti-inflammatory medication, like ibuprofen or aspirin, may promote pain in the long term.

The paper, published in Science Translational Medicine, suggests that inflammation, a normal part of injury recovery, helps resolve acute pain and prevents it from becoming chronic. Blocking that inflammation may interfere with this process, leading to harder-to-treat pain.

"What we've been doing for decades not only appears to be wrong, but appears to be 180 degrees wrong," says senior study author Jeffrey Mogil, PhD, a professor in the department of psychology at McGill. "You should not be blocking inflammation. You should be letting inflammation happen. That's what stops chronic pain."

Inflammation: Nature's Pain Reliever

Wanting to know why pain goes away for some but drags on (and on) for others, the researchers looked at pain mechanisms in both humans and mice. They found that a type of white blood cell known as a neutrophil seems to play a key role.

"In analyzing the genes of people suffering from lower back pain, we observed active changes in genes over time in people whose pain went away," says Luda Diatchenko, PhD, a professor in the faculty of medicine and Canada excellence research chair in human pain genetics at McGill. "Changes in the blood cells and their activity seemed to be the most important factor, especially in cells called neutrophils."

To test this link, the researchers blocked neutrophils in mice and found the pain lasted 2 to 10 times longer than normal. Anti-inflammatory drugs, despite providing short-term relief, had the same pain-prolonging effect — though injecting neutrophils into the mice seemed to keep that from happening.

The findings are supported by a separate analysis of 500,000 people in the UK that showed those taking anti-inflammatory drugs to treat their pain were more likely to have pain 2 to 10 years later.

"Inflammation occurs for a reason," says Mogil, "and it looks like it's dangerous to interfere with it."

Rethinking How We Treat Pain

Neutrophils arrive early during inflammation, at the onset of injury — just when many of us reach for pain medication. This research suggests it might be better not to block inflammation, instead letting the neutrophils "do their thing." Taking an analgesic that alleviates pain without blocking neutrophils, like acetaminophen, may be better than taking an anti-inflammatory drug or steroid, says Mogil.

Still, while the findings are compelling, clinical trials are needed to directly compare anti-inflammatory drugs to other painkillers, the researchers said. This research may also lay the groundwork for new drug development for chronic pain patients, Mogil says.

"Our data strongly suggests that neutrophils act like analgesics themselves, which is potentially useful in terms of analgesic development," Mogil says. "And of course, we need new analgesics."

https://www.medscape.com/viewarticle/975853

As FTC cracks down on pharma M&A, analyst sees potential chilling effect on large deals

 The U.S. antitrust watchdog believes that its current process of reviewing large pharma mergers just doesn’t work. As experts propose heightened scrutiny, at least one analyst is projecting a potential chilling effect on big pharma deals.

Since March 2021, the U.S. FTC has been working with international counterparts to revamp pharma antitrust reviews. Eventually, the agencies will likely adopt a holistic approach, which may discourage mid-to-large size deals, Berenberg analyst Zhiqiang Shu, Ph.D., wrote in a Thursday note.

The FTC has become concerned about the consolidation in the biopharma industry and the growing market power of existing leaders through M&A.

“We must not limit our enforcement to existing products and pipeline products,” U.S. Federal Trade Commissioner Rebecca Kelly Slaughter said during a two-day virtual workshop on exploring new approaches to reviewing pharma M&A.

During the event this week, experts argued that scale doesn’t drive innovation in biopharma. Over the past few years, large pharma’s share of new compounds has slowly declined, Patricia Danzon, an expert of healthcare economics at the University of Pennsylvania, said during the event. These days, small firms now contribute about 70% of novel drug entities.

Meanwhile, studies have found that after mergers, combined companies’ R&D output declines, Arti Rai of Duke University noted. This raises concerns that large mergers may become “killer acquisitions,” in which the purchaser hampers innovation by buying out competition. Still, this falls within the FTC’s existing antitrust practice of looking at overlap between portfolios and pipelines.

FTC’s Slaughter also wants to review the effects of proposed mergers on innovation industrywide, not just R&D at the merging firms. She pointed out, for example, that if a merger reduces the number of large pharma companies that could be potential buyers of new technologies from biotech startups, that deal may in turn affect the availability of capital to the startups. This could give the merged firm power and incentive to foreclose other innovators, thus deterring investment.

Experts also voiced concerns with the increased bargaining power of large firms in drug pricing negotiations. If a merged biopharma owns a “must-have” or blockbuster product, the company could bundle the star med with new assets gained from the acquisition and force higher prices, Danzon said. Many studies have shown a strong connection between high market concentration and rising drug prices, she added.

That’s why Danzon is suggesting that the FTC dig into the past drug contracting practices of companies involved in proposed mergers.

During the event initiated by the FTC and the U.S. Department of Justice, experts generally agreed that past bad actors who have engaged in anti-competition tactics should receive extra scrutiny. These tactics include pay-for-delay deals, which involve paying a generic developer to postpone the launch of a generic drug; product-hopping, which involves switching patients to patented drugs while winding down older, off-patent alternatives; and patent thickets, Berenberg’s Shu noted.

“Conduct is informative of intent, which is indicative of effect,” Shu observed in his note.

Shu expects the FTC will incorporate more factors into a holistic approach to enforcing antitrust laws. The FTC has recently challenged several high-profile hospital mergers, arguing they would increase prices and reduce the quality of care, Shu noted.

If the FTC’s current stance on hospital mergers is any indication of the direction U.S. regulators are taking, Shu said “it is reasonable to believe” that the FTC and DOJ “will likely challenge large and mega-mergers” in the biopharma sector moving forward.

https://www.fiercepharma.com/pharma/pharma-mas-land-ftcs-crosshairs-experts-propose-expansive-ways-tighten-antitrust-reviews

FTC puts drugmaker and PBM rebates in the crosshairs over mounting insulin prices

 U.S. regulators are cracking down on bribes and rebate schemes between drugmakers and pharma middlemen, with a specific focus on mounting insulin prices.

The Federal Trade Commission (FTC) said it would ramp up its enforcement efforts against such practices that “block patients’ access to competing lower cost drugs,” voting 5-0 Thursday to issue its new policy statement.

The move comes a little more than a week after the FTC unveiled plans to probe six of the largest PBMs in the U.S.

With the latest enforcement policy statement, meanwhile, FTC warns that it’s putting pharma companies and prescription intermediaries “on notice” that rebates and anti-competitive fees to exclude cheaper drug alternatives could run afoul of competition and consumer protection laws.

Most patients’ insurance covers at least part of their prescription medicine costs. Those health plans are typically orchestrated by so-called drug middlemen like pharmacy benefit managers and often use formularies to define the medicines they’ll cover. In turn, drugmakers use rebates to secure spots for their medicines on formularies or “preferred tiers of formularies to ensure those drugs are covered,” FTC added.

Thing is, those rebates are often conditioned on the drug keeping its preferred formulary position, and some rebates and fees hinge on the sales volume of certain pricey prescription meds, FTC said.

“In addition to other factors, some have suggested that high rebates and fees to PBMs and other intermediaries may incentivize higher list prices for drugs and discourage coverage of the lowest-cost products,” the regulator pointed out in its release.

The FTC’s rebate practice concerns extend specifically to insulin, which some 8 million people in the U.S. use to keep their diabetes in check, FTC noted. The regulator flagged the fact that insulin list prices have “soared over the last two decades, increasing by over 300 percent.”

That can translate into higher costs for certain patients, the FTC noted. As of 2017, the average list price for a one-year supply of insulin clocked in at around $6,000. Uninsured patients had to pay out-of-pocket costs up to $1,288, while those with insurance paid around $613 out-of-pocket on the low end.

There are several legal levers the FTC can pull when “dominant drug companies pay rebates and fees to middlemen to foreclose competition from less expensive generic and biosimilar alternatives,” the commission said.

Under certain federal laws, the industry’s rebate shenanigans could constitute unreasonable agreements in restraint of trade, unlawful monopolization or exclusive dealing, the FTC said.

Further, “inducing” PBMs and other intermediaries to slot pricier drugs on their formularies instead of cheaper alternatives could prove anti-competitive under FTC regulations when the cost burden is shifted to payers and patients.

Finally, paying or accepting rebates or fees to exclude cheaper drugs from prescribing lists “may constitute commercial bribery,” FTC said.

As for the FTC’s separate investigation into six PBM juggernauts, the regulator earlier this month said it had sent compulsory orders to CVS Caremark, Express Scripts, Optum Rx, Humana, Prime Therapeutics and MedImpact Healthcare Systems, requiring them to submit information and records on their business practices.

Meanwhile, this is hardly the first time steep insulin prices have raised anti-competitive flags. Last month, Eli Lilly, Sanofi and Novo Nordisk were slapped with a lawsuit by Arkansas, which is suing the trio of diabetes giants and top PBMs for allegedly driving up the cost of insulin.

Arkansas Attorney General Leslie Rutledge argued the companies conspired with PBMs to spike insulin prices and drive up revenues, making the treatments unaffordable for diabetics in her state.

https://www.fiercepharma.com/pharma/ftc-puts-drugmaker-and-pbm-rebates-crosshairs-over-mounting-insulin-prices