Abortion Opponents Don't Want Patients Crossing State Lines

 Several national anti-abortion advocacy groups and lawmakers in Republican-led states are pushing forward with plans to block people from crossing state lines to seek the procedure elsewhere.

Since the Supreme Court overturned Roe v. Wade last week, several states have enacted "trigger ban" laws to stop abortion, particularly across the Southeast and Midwest. As part of that, anti-abortion groups are building momentum around the idea of blocking out-of-state travel as well, even discussing it at two national anti-abortion conferences last weekend, according to The Washington Post .

"Just because you jump across a state line doesn't mean your home state doesn't have jurisdiction," Peter Breen, vice president and senior counsel for the Thomas More Society, told the newspaper.

"It's not a free abortion card when you drive across the state line," he said.

The Thomas More Society, a conservative legal organization, is drafting model legislation for state lawmakers to use, which would allow private citizens to sue anyone who helps a resident end a pregnancy outside of a state that has banned abortion. The draft language borrows from the recent Texas abortion ban, which allows private citizens to enforce the law through civil litigation.

The National Association of Christian Lawmakers, an anti-abortion organization led by Republican state legislators, has also begun working with the authors of the Texas abortion ban, the Post reported. The group is exploring model legislation that would restrict people from crossing state lines for abortions.

Relying on private citizens to enforce civil litigation, rather than imposing a state-enforced ban on crossing state lines, could make these laws more difficult to challenge in court.

What's more, the legislation could have a chilling effect on doctors, who may stop performing abortions on people from other states while waiting on courts to intervene and overturn the laws, the newspaper reported.

Not every anti-abortion group is supporting the idea. Catherine Glenn Foster, president of Americans United for Life, said that people access medical procedures across state lines often.

"I don't think you can prevent that," she said.

But some states may still propose these types of bills this year. Legislators in Arkansas and South Dakota, for instance, have already planned special sessions to discuss abortion legislation, which could include the issue. Lawmakers in Missouri have also supported the idea.

In contrast, several Democrat-led states have passed legislation this year to counteract laws that may try to restrict movement across state lines, according to the Post. Connecticut passed a law that offers protection from out-of-state subpoenas issued in cases related to abortion procedures that are legal in the state, and California passed a similar law to protect abortion providers and patients from civil suits.

The Justice Department has warned that it will fight laws that block people from crossing state lines, saying they violate the right to interstate commerce.

"The Constitution continues to restrict states' authority to ban reproductive services provided outside their borders," Attorney General Merrick Garland said in a statement after last week's ruling.

"We recognize that traveling to obtain reproductive care may not be feasible in many circumstances," he said. "But under bedrock constitutional principles, women who reside in states that have banned access to comprehensive reproductive care must remain free to seek that care in states where it is legal."

Sources

The Washington Post: "Antiabortion lawmakers want to block patients from crossing state lines."

U.S. Department of Justice: "Attorney General Merrick B. Garland Statement on Supreme Court Ruling in Dobbs v. Jackson Women's Health Organization."

https://www.medscape.com/viewarticle/976458

High Rate of Undiagnosed Major Risk Factors in Ischemic Stroke

 Almost two thirds of patients with acute ischemic stroke have at least one undiagnosed major risk factor, new research shows.

The most common of these are dyslipidemia, hypertension, and atrial fibrillation (AF). In addition, many of the study participants were women and were relatively younger.

André Rêgo, MD

These results highlight the need for greater clinician awareness about how this patient population may have unrecognized stroke risk factors, study investigator André Rêgo, MD, Stroke Center, Department of Clinical Neurosciences, Lausanne University Hospital and University of Lausanne, Switzerland, told Medscape Medical News.

He used the example of a younger female patient who lives a sedentary lifestyle, eats an unbalanced diet, takes oral contraceptives, and smokes. "If you add one or two more risk factors, like an undiagnosed dyslipidemia or mild hypertension, that can be a dangerous cocktail," he said.

The findings were presented at the Congress of the European Academy of Neurology (EAN) 2022.

Need for Greater Focus on Prevention

Research shows about 90% of strokes are caused by modifiable risk factors, including hypertension, dyslipidemia, diabetes, AF, structural cardiac disease, high body mass index, smoking, psychosocial issues, physical inactivity, and unhealthy diet.

Some of these risk factors, such as overweight or obesity, are obvious; others, like hypertension and dyslipidemia, are frequently silent.

The analysis included 4354 patients from a database of patients admitted to a single center within 24 hours of a stroke between 2003 to 2018.

About 25.8% were unaware of having major risk factors, and 74.2% had diagnosed risk factors. Participants' mean age was 59.02 years in the unaware group and 73.8 years in the aware group.

When comparing risk factors between the two study groups, investigators focused on hypertension, dyslipidemia, AF, and silent/new coronary heart disease combined with an ejection fraction of less than 35%.

Of the 25.8% of patients with acute ischemic stroke who were unaware that they had stroke risk factors, 67.7% had at least one major risk factor.

In patients with previously undiagnosed risk factors, 61.4% had newly detected dyslipidemia, hypertension (23.7%), AF (10.2%), diabetes (5.2%), ejection fraction of less than 35% (2.0%), and coronary disease (1.0%).

"These results were kind of surprising because in Switzerland, the healthcare system is really good and people are highly educated," said Rêgo.

The unaware group had a higher percentage of smokers as well as more non-White and younger patients. These patients were also less likely to have taken aspirin at stroke onset and more likely to be overweight. Women who were unaware of their stroke risk factors were more likely to be taking contraceptives. There was also a higher frequency of patent foramen ovale–related strokes in the unaware group.

Rêgo believes a combination of elements probably contributes to the underdiagnosis of stroke risk factors, including poor healthcare access and individuals perceiving themselves to be healthy if they're young and not overweight.

Analysis of long-term functional outcomes showed no differences between groups in modified Rankin scale scores after adjusting for age, sex, peripheral artery disease, chronic kidney disease, depression, psychosis, and cancer.

"This probably means that irrespective of etiology, we are treating stroke patients quite well," said Rêgo.

The results may not be generalizable to other countries, he said, noting that Switzerland is "highly developed" with an educated, relatively healthy population. "If we did this study in another context, we probably would see even more undiagnosed risk factors."

Improving the detection of undiagnosed risk factors would require a shift in focus, said Rêgo. "We still have a healthcare system excessively directed toward acute disease and less to chronic diseases and preventive medicine."

Room for Improvement

Commenting for Medscape Medical News, Nicola Rifino, MD, Cerebrovascular Department, University of Milano-Bicocca, Milan Italy, who chaired the session featuring the research, said that the study "sends a clear message" that much more can be done to prevent cerebrovascular ischemic events.

That more than two thirds of patients have undiagnosed vascular risk factors "is certainly surprising," but this finding could serve as "an incentive for clinicians to do more in prevention," he said.

He noted that many risk factors are treatable, both pharmacologically and with changes in lifestyle. "Identifying and treating these risk factors early can likely prevent many of the ischemic strokes that occur on a daily basis."

Dr Rêgo reports no relevant conflicts of interest.

Congress of the European Academy of Neurology (EAN) 2022. Abstract # A-22-04456. Presented June 26, 2022.

https://www.medscape.com/viewarticle/976455

FDA’s ban on a popular e-cigarette defies logic

 The Food and Drug Administration has once again exposed a deadly menace to Americans’ health: the FDA itself. The rate of smoking has plummeted among Americans in the past decade, but now the agency’s empire-building bureaucrats are doing their best to reverse that trend.

The FDA has ordered Juul to stop selling its electronic cigarette (popularly known as the Juul), the most effective technology ever devised for inducing smokers to quit. The agency is also proposing to limit the amount of nicotine in traditional cigarettes, an approach that has failed in the past to wean smokers off their habit—and would perversely induce them to get their nicotine in more dangerous ways, either by smoking more cigarettes or by buying full-strength ones on the black market.

The Juul ban, temporarily suspended by a federal judge as Juul appeals the FDA’s order, defies not only the principles of public health but also political common sense: Why antagonize millions of voters in an election year by taking away their vaping sticks? The FDA conceded that it could point to no “immediate hazard” to the public from the Juul. It claimed that the company didn’t provide enough information on the Juul’s safety, but that claim is dubious—Juul spent more than $100 million on its application to the FDA. In any case, it’s silly to quibble about minor unknown risks in electronic cigarettes, which the U.K.’s public-health agency estimated to be 95 percent safer than tobacco cigarettes.

The ban makes sense only as a sop to the bureaucrats and special interests threatened by e-cigarettes, which provide the many benefits of nicotine—weight control, improved concentration and cognitive performance, reduced anxiety and better mood—without the thousands of toxins in tobacco smoke. Like caffeine, nicotine creates dependence and causes slight temporary rises in blood pressure, but both are “fairly harmless,” as the British Royal Society for Public Health concluded.

Anti-vaping activists and their allies at the FDA have claimed that e-cigarettes serve as a “gateway” to smoking for teenagers, but the rate of teenage smoking has fallen much faster during the vaping era than in previous years. When e-cigarettes were introduced a decade ago, 13 percent of high school students smoked; today the figure is less than 2 percent.

No one wants to see teenagers addicted to nicotine, but it is already illegal for them to buy e-cigarettes. Surveys show that the rate of vaping among high school students has declined sharply in the past two years, and that most teenage vapers do so only occasionally, often without nicotine. (A majority of them report using vaping devices for marijuana, yet progressive activists aren’t using that as reason to ban marijuana sales to adults.)

The rate of smoking among adults has also declined sharply during the vaping era, especially after the introduction of the Juul, and the health benefits have been obvious. A recent study, which tracked more than 30,000 Americans for six years, found that the rate of cardiovascular disease among e-cigarette users was a third lower than the rate among smokers, and no different from the rate among people who neither smoked nor vaped.

Other studies have shown that e-cigarettes help smokers quit and are far more effective than other nicotine-replacement therapies (like nicotine patches or gum). Even smokers with no intention to quit are much likelier to do so if they use an e-cigarette at least once a day. Juul has been particularly successful because it provides a high dose of nicotine in a form that is absorbed quickly, as in a tobacco cigarette. One study found that 50 percent of smokers who bought Juuls went on to quit smoking within a year. Another showed that smokers are more likely to quit if they use a full-strength Juul rather than one with less nicotine.

This is all wonderful news for public health, but bad news for companies that market less effective smoking-cessation products, as well as for the activists, academics, and bureaucrats who have built careers fighting cigarettes. Now that so many Americans have used vaping devices to quit smoking on their own, how can the anti-smoking activists justify their jobs? A lot of money is at stake: more than $800 million a year that the FDA collects from tobacco user fees, which are supposed to be dedicated to improving health by reducing the harm from tobacco products.

To keep the money flowing, bureaucrats misleadingly defined the e-cigarette as a “tobacco product” and set a new goal of eliminating the regular use of nicotine. Since beginning its campaign against e-cigarettes, the FDA’s Center for Tobacco Products has more than doubled the size of its staff, to over 1,100 people, and it has been dispensing hundreds of millions of dollars annually in outside grants, much of it to nonprofits spreading anti-vaping messages and to researchers who advocate for nicotine prohibition.

Unfortunately, the FDA’s misinformation campaign has been a success, aided by mainstream journalists who created a moral panic by blaming e-cigarettes for deaths that were actually caused by black-market THC products. Early in the vaping era, most Americans realized that e-cigarettes are safer than tobacco cigarettes, but in subsequent surveys a majority say that e-cigarettes are as dangerous or even more dangerous—a mistaken belief that will shorten many smokers’ lives.

Nicotine prohibition is a pointless and unrealistic goal. Alcohol abuse is a much bigger problem than smoking among teenagers, but we’ve learned that banning alcohol sales to adults would create far more problems than it would solve. The same is true for e-cigarettes. If the FDA succeeds in banning Juul and similar products, Americans will simply revert to tobacco cigarettes or turn to modern bootleggers for less safe vaping devices.

“There are at least 4 million adult ex-smokers who quit smoking successfully using e-cigarettes and remain dependent on these products to stay off of cigarettes,” says Michael Siegel of Tufts University, who has been studying tobacco control for three decades. “If the FDA disapproves most electronic cigarettes, the end result will be huge numbers of ex-smokers returning to smoking, which would be a public health tragedy.”

In the FDA’s fantasy world, smokers will be saved once the level of nicotine in cigarettes is lowered to “non-addictive” levels. The agency last week announced plans to limit the level of nicotine in all cigarettes, and it has even declared very low-nicotine cigarettes to be “appropriate for the protection of public health.” It’s a bizarre endorsement for a deadly product, especially considering the past failure of low-nicotine cigarettes to get smokers to quit, as University of Louisville professor of medicine Brad Rodu has pointed out.

“If the only cigarettes the FDA allows are low-nicotine, this is a perfect setup for the black market,” says Rodu, who writes the Tobacco Truth blog. “The FDA has banned Juul, a far less hazardous and uniquely successful cigarette substitute for millions of American adult smokers, while endorsing cigarettes that contain virtually none of the essentially harmless nicotine and all of the toxins of traditional cigarettes. These illogical actions will have no impact on the yearly smoking death toll of a half-million Americans—or they may perversely raise it.”

For now, the best hope for sane policy remains outside the FDA. Perhaps the courts will protect Juul against the FDA’s folly, and perhaps politicians facing reelection will stand up for voters who enjoy nicotine. But as long as the agency—and its $800 million in tobacco fees—remain under the control of nicotine prohibitionists, the FDA will remain hazardous to Americans’ health.

John Tierney is a contributing editor of City Journal and coauthor of The Power of Bad: How the Negativity Effect Rules Us and How We Can Rule It.

https://www.city-journal.org/fda-war-on-juul-is-bad-health-policy

CDC is deceiving us again — this time covering up for unsafe hospitals

 If you have to go to the hospital, you don’t want to end up in a dangerous one. The Centers for Disease Control and Prevention knows which hospitals are riskiest, but it’s hiding that information from you — your safety be damned. The feds seem to think they work for the hospital industry, not for you.

Whenever a hospital has a superbug outbreak, the CDC conceals its identity, referring only to “Hospital A.” A lot of good that does patients looking for safe care, especially patients with compromised immune systems, cancer or HIV.

It’s no joke to find out, after you’re already in the hospital, that a superbug is raging room to room or has invaded the nursery where your newborn will be placed. That’s what happens when the CDC hides outbreaks.

Now the CDC is playing statistical tricks to hide how many people have caught COVID in hospitals and to block the public from seeing which hospitals have had the biggest problems — “partly on fears of embarrassing hospitals,” Politico reports.

The stakes are high; 21% of patients who catch COVID in the hospital never make it out, Kaiser Health News found — triple the death rate for patients who don’t catch COVID.

Though the pandemic may be fading, vulnerable patients need to know which hospitals proved proficient at preventing the spread of COVID inside their walls. It’s a safety measure.

Kaiser Health News found that 21% of patients who catch COVID in the hospital never make it out.

AP/Gerald Herbert

Over the course of the pandemic, tens of thousands of patients went into the hospital for other reasons — such as hip surgery, kidney disease or a heart attack — and got infected with COVID.

The CDC is rigging the definition of hospital-acquired COVID to hide this problem.

The agency says only patients who test positive after being hospitalized at least 14 days are considered infected by the hospital. That eliminates almost everyone. The average patient stays only 4.6 days.

The CDC definition also excludes any patient who left the hospital and then developed symptoms or picked up the virus in the emergency room.

It’s a coverup. The United Kingdom and many European countries count COVID infections diagnosed seven or eight days after patients enter as hospital-acquired.

At some hospitals, more than 5% of patients caught COVID there, according to a Kaiser Health News analysis of state data and Medicare billing data. The CDC refuses to name these hospitals, defying Freedom of Information Act requests from the media.

When a plane crashes, the Federal Aviation Administration doesn’t conceal the identity of the airline. Why does the CDC cover up for a hospital?

The CDC says only patients who test positive after being hospitalized at least 14 days are considered infected by the hospital.

AP/Ron Harris

To be fair, the pandemic hit some regions and some hospitals harder than others. But it’s also true that some hospitals took precautions to stop the virus from spreading and succeeded in providing safer care than others.

Some hospitals tested all incoming patients for the virus and retested days later to be sure. Testing proved critical, because most patients who contracted COVID in the hospitals got it from another patient. At Brigham and Women’s Hospital in Boston, eight out of nine patients who became infected caught COVID from the patient sharing their room, per the Annals of Internal Medicine.

Why didn’t all hospitals test? Blame the CDC, which left it to the “discretion of the facility.”

New Yorkers should demand to see the data the CDC is hiding. Hospital-acquired COVID is a problem here.

In January, during the Omicron surge, rates of hospital-acquired COVID were higher in New York than the national average, though lower than in Washington, DC, according to a Wall Street Journal analysis of unpublished federal data. Trouble is, citywide averages don’t tell you what you need to know — the adequacy of infection prevention in your hospital.

It’s time to end the CDC’s secrecy in the service of hospitals. The CDC’s ploy to hide hospital-acquired COVID is a red flag.

Call the CDC the Centers for Deception and Coverups. The nation should be demanding a health agency that deals honestly with the public. If you have health problems, your life could depend on it.

Betsy McCaughey is a former lieutenant governor of New York and founder of the Committee to Reduce Infection Deaths.

https://nypost.com/2022/06/28/the-cdc-is-deceiving-us-again-by-covering-up-for-unsafe-hospitals/

FDA: Don’t rush a move to change the Covid-19 vaccine composition

 On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19-2 to approve the use later this year of Covid-19 vaccines based on an Omicron variant sequence. One of us (P.A.O.) was among those voting “no.” It is possible these vaccines will be two-component designs that also include the current version. Will Americans soon be better protected against Covid-19?

The Covid-19 vaccines currently authorized for use in the U.S. are all based on the sequence of the original SARS-CoV-2 virus, which was obtained early in 2020. The virus has evolved over the past 30 months, creating variants that are either more infectious, or harder to counter by vaccination, or both. In late December 2021, the Omicron variant (BA.1) emerged, becoming the most dominant strain in the U.S. BA.1 has now been almost completely replaced by other Omicron-based variants. The BA.4 and BA.5 viruses currently account for 50% of all circulating strains. Earlier variants, like Alpha and Delta, have essentially vanished.

While vaccines made from the original SARS-CoV-2 strain provided strong protection against SARS-CoV-2 circulating in 2020 and 2021, the Omicron variants have been more problematic. They are highly resistant to neutralizing antibodies, which the human immune system uses to prevent infection. As a result, the Omicron viruses find it easier to break through this protective barrier, causing what are mostly mild infections. That’s true whether the neutralizing antibodies were elicited by vaccination or by earlier infection with Alpha or Delta variants. Fortunately, most people have enough neutralizing antibodies to strongly protect them against severe disease and death — that key task requires immune memory cells and lower neutralizing antibody levels than are needed to completely fend off the virus.

Once it became clear that the Omicron variants resisted neutralizing antibodies, thereby increasing the frequencies of mostly mild infections, vaccine companies began rapidly redesigning their Covid-19 vaccines. The revised vaccines were all based on the initial Omicron BA.1 sequence, which was an appropriate step to take. By now, most Americans already have antibodies against SARS-CoV-2’s spike protein because they were vaccinated or infected or both. As a result, the most frequent use of an Omicron-containing vaccine will be as a booster dose for certain high-risk groups.

What is known about Omicron-based vaccines? BA.1 versions have been tested as boosters in experimental animals and also in small-scale human trials. The goals of the studies were to measure the levels of neutralizing antibodies produced, compared to using the original vaccine as a booster under similar conditions.

The animal data have been around for several months. They are quite similar to what’s recently emerged from various human trials. Two to four weeks after the booster shots, neutralizing antibody levels against Omicron BA.1 were about twofold higher with the Omicron-based vaccine than with the original vaccine. Moderna recently released some information on a two-component Omicron plus original booster vaccine. The Omicron (BA.1) neutralizing antibody levels induced were higher than when the original vaccine was used by itself but, again, by less than two-fold. In contrast, Pfizer showed data at the VRBPAC meeting indicating that its two-component vaccine actually performed less well than an Omicron-only booster. Even allowing for the nature of very early data, the story on two-component vaccines is far from clear.

What do an approximately twofold higher level of neutralizing antibodies mean in practice? Is an Omicron-based booster sufficiently superior to the standard one to justify a switch?

That kind of twofold difference is, for example, similar to the modestly greater peak in neutralizing antibodies triggered by the first two doses of the Moderna vaccine compared with the Pfizer vaccine. Those two vaccines provided almost identical protection against mild and severe Covid-19, although the benefits of the Pfizer vaccine waned a bit quicker over time.

We would all gain from having more insights into the performance of the Omicron-based Covid-19 vaccines. The full datasets from all the variant booster trials should now be analyzed using the best available models to provide an informed judgement about whether — and to what extent — the slightly superior neutralizing antibody response to Omicron-based boosters translates into significantly greater protection against BA.4/BA.5-mediated infections and severe or fatal disease.

Moderna and Pfizer executives have claimed that the Omicron vaccines will be protective for longer. That may be true, but how long is longer? A few weeks? A month or two? Again, detailed modeling of the data might provide important information. It’s important to be sure that changing the booster vaccine to include the Omicron sequence offers enough of an advantage to justify the cost and complexity associated with making the switch.

The reason why the Omicron and earlier variant boosters are little or no better than a standard booster is rooted in immunology. The immune system responds to the first sight of the viral spike protein by making neutralizing antibodies and by starting to lay down memory cells that are an archive of what it is seeing. Those memory cells improve over a multi-month period and are then triggered into action when the immune system reencounters the spike protein, either as an infection or in a booster vaccination. The resulting neutralizing antibody response doesn’t appear to depend very much on whether the boost was with the original sequence, the Beta sequence, the Delta sequence, or the Omicron sequence — all are about equally as good at reawakening immune memory cells. The Omicron vaccines also seem to elicit some neutralizing antibodies that are unique to that variant and that make a minor contribution to the overall response. It’s possible that component could improve over time or after additional boosts, but we have no data to evaluate.

Because no one can predict how SARS-CoV-2 will further evolve, there’s no way to tell whether one or more Omicron-based boosts over the next year would be beneficial against what may emerge. What is known is that the increasingly prevalent BA.4 and BA.5 variants are even more resistant to neutralizing antibodies, typically by three- or four-fold, than the now-vanished BA.1 variant on which the Omicron vaccines are based. The trend toward greater resistance of neutralizing antibodies may well worsen.

Some experts have suggested that a booster should be based not on the BA.1 sequence but on BA.4/BA.5 sequences. To do that in a relevant time frame would mean foregoing clinical trials to obtain immunogenicity data. A reasonable assumption is that a booster based on BA.4/BA.5 would be better tailored to those now dominant strains. Nonetheless, the increase in neutralizing antibodies over the standard vaccine boost may still be only modest — probably on par with what’s being seen with the BA.1 boosters.

If an Omicron-based booster provides little advantage over the vaccine stocks that already exist, is it worth the switch? Making and rolling out an entirely new supply of Covid-19 vaccines on a nationwide basis is no trivial matter, particularly when Congress seems reluctant to provide the funds. Would the country be better off using the available resources to accelerate the creation of next-generation vaccines that can produce neutralizing antibodies in amounts high enough to deal with most variants? Or vaccines that can be delivered into the nose, a route that may provide stronger protection against infection? Strategic decisions of this nature require a deep dive into the immunology of how vaccines work; and the use of sophisticated models on neutralizing antibody actions.

Vaccines remain of critical importance at this stage of the pandemic. We strongly urge that everyone who needs a vaccine dose gets one, particularly never-vaccinated people who have been fooled by distortions about vaccine safety. But it’s important to understand what vaccines can and cannot now do, and what any composition switch really means for protection against Covid-19.

Perhaps researchers will learn that particularly vulnerable people, like those who are older or sicker, might benefit sufficiently to justify the use of an Omicron-based booster, but the wider population would not. Decisions could be tailored to specific sub-populations.

Whatever the decision, Americans will need to receive accurate information about how the new boosters perform against mild infections and virus transmission. It isn’t likely that an Omicron-based booster will be a magic bullet, although it might be perceived that way. It is essential to avoid offering people a false sense of security. Those who recently received an Omicron booster should not think they are now bulletproof against SARS-CoV-2 and increase their infection risk by altering their behavior. There are signs that behavioral changes may already be visible in infection statistics from the Centers for Disease Control and Prevention.

A multibillion-dollar decision to launch a vaccine based wholly or in part on the BA.1, BA.4, or BA.5 sequence that would affect more than 100 million people need not be unduly rushed. A decision of this magnitude should be based on as much expertise and analysis as is reasonably practical. Our joint concern is that this may not be what happens in the coming days, when the FDA will likely accept the majority advice given by its advisory committee without fully weighing what the exact composition of the new vaccine should be, and assessing whether it confers significant advantages over the current vaccine. Using an additional week or two to obtain more input seems a prudent step to take.

John P. Moore is a professor of microbiology and immunology at Weill Cornell Medicine in New York City. Paul A. Offit is a pediatrician, professor of pediatrics, and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, and a member of the FDA’s Vaccines and Related Biological Products Advisory Committee.

https://www.statnews.com/2022/06/29/fda-dont-rush-to-change-covid-19-vaccine-composition/

Open the books on NIH royalty payments

 Recently, Sen. Rand Paul (R-KY) pressed Dr. Anthony Fauci for details of hidden royalty payments made to the National Institutes of Health, its leadership, and scientists. Once again, Fauci was evasive and misleading in a congressional hearing. If his agency has nothing to hide, he should open the books and share all the information with the public.

For years, the NIH has worked to keep hidden a stream of third-party royalties paid to its scientists by for-profit companies. These payments flow when a medical innovation made as part of NIH research is used by the private sector and government employees are considered “co-inventors” on the patent. There were approximately 55,000 of those payments during the past decade. Each royalty could be a conflict of interest that requires transparency to investigate.

After the agency ignored Freedom of Information Act requests from OpenTheBooks's data capture team, we sued the agency, represented by the group Judicial Watch. Only recently and under court order has the NIH begun disclosing the amount of money changing hands with the private sector for these innovations. As officials slow-walk the royalty data release, we can say that the NIH and its scientists received an estimated $400 million in third-party paid royalties between March 2010 and today and that they dole out around $32 billion a year in research grants across the medical community. Concurrently, decisions inside the NIH, the Food and Drug Administration, and the wider Department of Health and Human Services were made regarding product approvals, public health guidance, and continuing research priorities.

These huge financial stakes make it critical for patients and the public to have full transparency from the NIH. People, the press, pundits, and watchdogs must be able to follow the money.

However, in the production of this information, the NIH is redacting every individual payment amount, the identity of the payer, and the patent license numbers. So we know hundreds of millions of dollars enrich the NIH and its scientists, but the NIH refuses to tell who is paying, at what amounts, and for which innovations. It renders these document dumps effectively useless.

Our OpenTheBooks investigation has thankfully sparked interest and action from Congress, which began last month in a budget hearing in which acting NIH Director Lawrence Tabak answered questions about 2023 funding levels. Rep. John Moolenaar (R-MI) got Tabak to concede that this whole arrangement appeared to be a conflict of interest. But Tabak contended that there are “firewalls” in place to ensure decision-makers were not receiving payments for innovations their subagencies were researching or overseeing. We are meant simply to take their word for it, it seems.

Based on Fauci’s testimony this week, that approach won’t suffice.

When Paul asked whether Fauci ever received royalty payments from entities he later regulated or made funding decisions for, Fauci demurred, saying he didn’t know, “but I doubt it.” In 2005, though, he was sure. Back then, Fauci confirmed that the payments were a conflict of interest because the National Institute of Allergy and Infectious Diseases, the institute where Fauci is the director, was spending $36 million to test his invention on patients — the interleukin-2 experimental AIDS drug.

However, the concern here is much broader than the behavior of the NIH’s most famous scientist.

Take another example, Dr. Doug Lowy, the acting director of the National Cancer Institute, another NIH institute. He is tied for 19th of 1,805 scientists receiving the most royalty payments between 2010 and 2016. Lowy studied papillomaviruses for decades, from how they reproduce to how they encode cancerous cells in the human body. He wrote hundreds of papers on these viruses, and then his laboratory developed and tested the ingredients now used in three HPV vaccines approved for use by the FDA: Gardasil, Gardasil 9, and Cervarix. From his new perch as acting director, Lowy makes all manner of decisions about grant-making priorities and cancer research using tax dollars.

Presciently, in the hearing, Paul asked Fauci a vaccine-related question as well: Has anyone on the vaccine approval committees ever received money from vaccine manufacturers? Fauci’s answer mirrored Tabak’s: Existing statutes and regulations don’t require these disclosures.

Paul is right to be asking for transparency here. He was joined by Sens. Tim Scott (R-FL), Ron Johnson (R-WI), Josh Hawley (R-MO), and Jim Lankford (R-OK) in sending Tabak a letter demanding the answers the NIH had refused to give to OpenTheBooks. They set a deadline of June 17, which has come and gone.

The public deserves the unredacted information because it’s the public's tax dollars being used to fund this revolving door of grants and royalties. If the NIH can hide behind the law, Congress should press forward with its oversight authorities by holding more hearings — and also update relevant statutes to ensure it serves the public’s present-day interests.

Let’s vaccinate our government bureaucracies, leadership, and scientists against these myriad conflicts of interest. Transparency is needed to build back trust.

Adam Andrzejewski is the CEO and founder of OpenTheBooks, the largest private database of public-sector expenditures.

https://www.washingtonexaminer.com/opinion/op-eds/open-the-books-on-nih-royalty-payments

Mo. Health System Briefly Halts 'Plan B' Amid Abortion Ban Confusion

 A Missouri-based health system will once again provide emergency contraception after briefly stopping days earlier, in another example of the legal confusion affecting healthcare systems in the aftermath of the Supreme Court overturning Roe v. Wade last week.

Early this week, Saint Luke's Health System, a network of 16 hospitals and campuses in the Kansas City area, announced it would stop providing emergency contraception -- including Plan B -- to patients in their Missouri-based locations. The decision was made in an effort to avoid legal ramifications for their physicians based on the state's abortion ban that went into effect on June 24.

On Wednesday, Saint Luke's reversed its decision.

According to a statement provided to MedPage Today, the reversal was made after additional "internal review." The health system will resume offering emergency contraception "under new protocols," while they monitor the evolving legal status of contraceptives.

"The ambiguity of the law, and the uncertainty even among state officials about what this law prohibits, continues to cause grave concern and will require careful monitoring," the statement said. "This is especially true because the penalty for violation of the statute includes the criminal prosecution of healthcare providers whose sole focus is to provide medically necessary care for their patients."

The health system's announcements highlight the legal uncertainty of providing reproductive healthcare in the aftermath of the Supreme Court's decision, as well as new potential legal jeopardy for physicians practicing in states with newly enacted abortion bans.

Part of that uncertainty was fueled by statements made by Missouri Governor Mike Parson and Missouri Attorney General Eric Schmitt over the past week.

Last Friday, Gov. Parson's office announced that the state law banning abortion -- which he signed in 2019 -- would formally take effect immediately. Attorney General Schmitt's office also released an official opinion confirming that the new law would go into effect immediately.

The law, known as the "Right to Life of the Unborn Child Act," contained several provisions outlawing abortion services in the state. At least two of those provisions target actions taken by physicians directly, according to a press release from the governor's office.

One provision prohibits performing abortions unless for medical emergencies, and the other establishes criminal liability for anyone who "knowingly performs or induces" an abortion that is not required by a medical emergency. The law also states that physicians could have their professional licenses suspended for performing an abortion, the press release noted.

Missouri is one of more than a dozen states with similar "trigger laws" that were set to go into effect after Roe was overturned.

The announcement prompted Saint Luke's initial decision to stop providing emergency contraception to avoid any potential legal liability for the health system's physicians. Then, state officials provided more detail about the legal use of emergency contraceptives, prompting the change to resume the practice, Saint Luke's said.

On Wednesday, Gov. Parson sent a tweet to clarify the legal status of contraceptives under the new law. "To address any misinformation: Missouri law has not changed the legality of contraceptives. Contraceptives are not abortions and are not affected by the Right to Life of the Unborn Child Act," the tweet read.

Saint Luke's stated that it will continue to "closely monitor legal developments regarding Missouri's abortion trigger law," as it resumes providing emergency contraception.

https://www.medpagetoday.com/special-reports/features/99526