Despite Controversies, Many Older People Have Faith in Vaccines

By Paula Span, KFF Health News

Kim Beckham, an insurance agent in Victoria, Texas, had seen friends suffer so badly from shingles that she wanted to receive the first approved shingles vaccine as soon as it became available, even if she had to pay for it out-of-pocket.

Her doctor and several pharmacies turned her down because she was below the recommended age at the time, which was 60. So, in 2016, she celebrated her 60th birthday at her local CVS.

“I was there when they opened,” Beckham recalled. After getting her Zostavax shot, she said, “I felt really relieved.” She has since received the newer, more effective shingles vaccine, as well as a pneumonia shot, an RSV vaccine to guard against respiratory syncytial virus, annual flu shots and all recommended covid-19 vaccinations.

Some older people are really eager to be vaccinated.

Robin Wolaner, 71, a retired publisher in Sausalito, California, has been known to badger friends who delay getting recommended shots, sending them relevant medical studies. “I’m sort of hectoring,” she acknowledged.

Deana Hendrickson, 66, who provides daily care for three young grandsons in Los Angeles, sought an additional MMR shot, though she was vaccinated against measles, mumps, and rubella as a child, in case her immunity to measles had waned.

For older adults who express more confidence in vaccine safety than younger groups, the past few months have brought welcome research. Studies have found important benefits from a newer vaccine and enhanced versions of older ones, and one vaccine may confer a major bonus that nobody foresaw.

The new studies are coming at a fraught political moment. The nation’s health secretary, Robert F. Kennedy Jr., has long disparaged certain vaccines, calling them unsafe and saying that the government officials who regulate them are compromised and corrupt.

On June 9, Kennedy fired a panel of scientific advisers to the Centers for Disease Control and Prevention, and later replaced them with some who have been skeptical of vaccines. But so far, Kennedy has not tried to curb access to the shots for older Americans.

The evidence that vaccines are beneficial remains overwhelming.

The phrase “Vaccines are not just for kids anymore” has become a favorite for William Schaffner, an infectious diseases specialist at Vanderbilt University Medical Center.

“The population over 65, which often suffers the worst impact of respiratory viruses and others, now has the benefit of vaccines that can prevent much of that serious illness,” he said.

Vaccines Reduce Hospitalizations

Take influenza, which annually sends from 140,000 to 710,000 people to hospitals, most of them seniors, and is fatal to 10% of hospitalized older adults. 

For about 15 years, the CDC has approved several enhanced flu vaccines for people 65 and older. More effective than the standard formulation, they either contain higher levels of the antigen that builds protection against the virus or incorporate an adjuvant that creates a stronger immune response. Or they’re recombinant vaccines, developed through a different method, with higher antigen levels.

In a meta-analysis in the Journal of the American Geriatrics Society, “all the enhanced vaccine products were superior to the standard dose for preventing hospitalizations,” said Rebecca Morgan, a health research methodologist at Case Western Reserve University and an author of the study.

Compared with the standard flu shot, the enhanced vaccines reduced the risk of hospitalization from the flu in older adults, by at least 11% and up to 18%. The CDC advises adults 65 and older to receive the enhanced vaccines, as many already do.

More good news: Vaccines to prevent respiratory syncytial virus in people 60 and older are performing admirably.

RSV is the most common cause of hospitalization for infants, and it also poses significant risks to older people. “Season in and season out,” Schaffner said, “it produces outbreaks of serious respiratory illness that rivals influenza.”

Because the FDA first approved an RSV vaccine in 2023, the 2023-24 season provided “the first opportunity to see it in a real-world context,” said Pauline Terebuh, an epidemiologist at Case Western Reserve School of Medicine and an author of a recent study in the journal JAMA Network Open.

In analyzing electronic health records for almost 800,000 patients, the researchers found the vaccines to be 75% effective against acute infection, meaning illness that was serious enough to send a patient to a health care provider.

The vaccines were 75% effective in preventing emergency room or urgent care visits, and 75% effective against hospitalization, both among those ages 60 to 74 and those older.

Immunocompromised patients, despite having a somewhat lower level of protection from the vaccine, will also benefit from it, Terebuh said. As for adverse effects, the study found a very low risk for Guillain-Barré syndrome, a rare condition that causes muscle weakness and that typically follows an infection, in about 11 cases per 1 million doses of vaccine. That, she said, “shouldn’t dissuade people.”

The CDC now recommends RSV vaccination for people 75 and older, and for those 60 to 74 if they’re at higher risk of severe illness (from, say, heart disease).

As data from the 2024-25 season becomes available, researchers hope to determine whether the vaccine will remain a one-and-done, or whether immunity will require repeated vaccination.

People 65 and up express the greatest confidence in vaccine safety of any adult group, a KFF survey found in April. More than 80% said they were “very “or “somewhat confident” about MMR, shingles, pneumonia, and flu shots.

Although the covid vaccine drew lower support among all adults, more than two-thirds of older adults expressed confidence in its safety.

Shingles Vaccine Reduces Dementia Risk

Even skeptics might become excited about one possible benefit of the shingles vaccine: This spring, Stanford researchers reported that over seven years, vaccination against shingles reduced the risk of dementia by 20%, a finding that made headlines.

Biases often undermine observational studies that compare vaccinated with unvaccinated groups. “People who are healthier and more health-motivated are the ones who get vaccinated,” said Pascal Geldsetzer, an epidemiologist at the Knight Initiative for Brain Resilience at Stanford and lead author of the study.

“It’s hard to know whether this is cause and effect,” he said, “or whether they’re less likely to develop dementia anyway.”

So the Stanford team took advantage of a “natural experiment” when the first shingles vaccine, Zostavax, was introduced in Wales. Health officials set a strict age cutoff: People who turned 80 on or before Sept. 1, 2013, weren’t eligible for vaccination, but those even slightly younger were eligible.

In the sample of nearly 300,000 adults whose birthdays fell close to either side of that date, almost half of the eligible group received the vaccine, but virtually nobody in the older group did.

“Just as in a randomized trial, these comparison groups should be similar in every way,” Geldsetzer explained. A substantial reduction in dementia diagnoses in the vaccine-eligible group, with a much stronger protective effect in women, therefore constitutes “more powerful and convincing evidence,” he said.

The team also found reduced rates of dementia after shingles vaccines were introduced in Australia and other countries. “We keep seeing this in one dataset after another,” Geldsetzer said.

In the United States, where a more potent vaccine, Shingrix, became available in 2017 and supplanted Zostavax, Oxford investigators found an even stronger effect.

By matching almost 104,000 older Americans who received a first dose of the new vaccine (full immunization requires two) with a group that had received the earlier formulation, they found delayed onset of dementia in the Shingrix group.

How a shingles vaccine might reduce dementia remains unexplained. Scientists have suggested that viruses themselves may contribute to dementia, so suppressing them could protect the brain. Perhaps the vaccine revs up the immune system in general or affects inflammation.

“I don’t think anybody knows,” said Paul Harrison, a psychiatrist at Oxford and a senior author of the study. But, he added, “I’m now convinced there’s something real here.”

Shingrix, now recommended for adults over 50, is 90% effective in preventing shingles and the lingering nerve pain that can result. In 2021, however, only 41% of adults 60 and older had received one dose of either shingles vaccine.

A connection to dementia will require further research, and Geldsetzer is trying to raise philanthropic funding for a clinical trial.

And “if you needed another reason to get this vaccine,” Schaffner said, “here it is.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Scientific Review Dismantles Myths Behind ‘Opiophobia’

By Crystal Lindell

“There is little evidence that physicians and surgeons prescribing opioids for short-term pain relief leads to substantial levels of opioid use disorder (OUD), addiction, or death.”

That one sentence, found in a new scientific review, cuts straight to the heart of America’s irrational fear of opioids — also known as opiophobia.

Published in ACS Pharmacology & Translational Science and authored by John Bumpus, PhD, the paper looks at the irrational fear that prescribing opioids in any capacity is harmful – and how little evidence there is to back up such claims. 

Bumpus opens his report by saying that there is a false narrative that “even short-term (seven days or less) use of opioids under medical supervision to treat acute pain will often lead to opioid use disorder (OUD) and/or addiction.”

As a result of that narrative, many healthcare professionals and policy makers believe that the best way to address this problem is to “avoid using opioids altogether or to severely limit the use of prescription opioids, especially after surgery.” 

Bumpus says many providers also assume that limiting prescriptions will significantly reduce overdose deaths. Then he adds the line that cuts to the heart of opiophobia: 

“There is, however, substantial evidence that this is not the case.”

In that one sentence, Bumpus dismantles the main argument that’s often used to claim that opioid restrictions are necessary: the idea that such restrictions are “evidence-based.” 

His report lays out how opioid-related misconceptions have led to policy decisions that are not only unsupported by evidence — but are often harmful. Anyone who has had trouble accessing needed opioid medications over the last few years will find the article both cathartic and affirming.  

Bumpus, who’s a Professor of Chemistry and Biochemistry at the University of Northern Iowa, starts the paper by defining "'opiophobia'" based on the definition shared in a 2023 paper, “Opiophobia and the tragedy of needless pain”

Opiophobia led many patients and providers to “fear, avoid or condemn the use of these compounds,” which Bumpus calls ‘the most effective family of analgesics known.”

While large chunks of the report focuses on surgical patients in post-operative pain, Bumpus says that many chronic pain patients use opioids “successfully and appropriately,” but have been “adversely affected by the catastrophization of issues and misinformation surrounding the use of opioids and the opiophobia it has generated."

Bumpus asserts that anti-opioid zealots have gone too far. 

“Although opioid-free protocols and policies may have their benefits and role, for some physicians, researchers, administrators, and politicians, the elimination of opioids appears to have become a goal in and of itself,” he warns. 

Bumpus says there's an underlying assumption "that physicians and surgeons are currently overprescribing opioids." He then adds, "Nationally, this does not appear to be the case."

While the number of opioid prescriptions decreased by about 50% from 2010 to 2022, Bumpus says deaths involving prescription opioids have remained constant. Meanwhile, fatal overdoses from illicit fentanyl and other synthetic opioids have skyrocketed.

“It does not appear that prescription opioids are the major problem here,” Bumpus concludes

He says those advocating for severe opioid limitation often ignore the adverse effects of alternatives like acetaminophen.

"For example, annually in the U.S., acetaminophen overdose is responsible for over 56,000 emergency department visits, 2600 hospitalizations and 500 deaths,” he writes. “Acetaminophen overdose is also the most common cause of acute liver failure and the most common reason for liver transplants in the U.S."

He says that "the narrative that the opioid crisis is caused by the prescribing habits of ethical, conscientious, and caring physicians is patently untrue."

Rather, what is true is that the “undertreatment of postoperative pain is a serious ongoing concern.”

Misleading Data Used to Justify Opioid Restrictions

While opioid-restricting polices may be well-intentioned, Bumpus says there is little evidence that physicians prescribing opioids for short-term pain leads to substantial levels of misuse.

For example, some of the claims used to justify opioid restrictions rely on a study that found 30% of Medicaid patients prescribed an opioid for the first time developed opioid dependency.

That is claim is misleading. The researcher was simply citing the fact that 30% of patients who filled a single opioid prescription needed a refill 3 to 9 months later. Getting a refill alone hardly meets the criteria for opioid dependency, much less addiction.

Bumpus says opioid restrictive policies have had the unintended effect of encouraging patients to store leftover opioids at home, which only makes them more likely to be misused by someone else. 

"Ironically, programs aimed at reducing access to opioids and their long-term storage may actually incentivize the hoarding of these medications," he says. 

People storing leftover opioids is understandable though, when patients fear their future pain will be untreated or they won’t be able to see a doctor.

"Long-term storage of opioid medications and self-medication may not be behaviors endorsed by the medical profession,” Bumpus says. “However, such behaviors are understandable human reactions, and they undoubtedly occur." 

Bumpus argues that while it’s illegal and medically unsupervised, using leftover prescription opioids is safer than turning to street drugs:

“These drugs serve as a relatively safe supply of opioids for people who use them,” he writes.

Ultimately, Bumpus says the public “should have access to information that accurately portrays the benefits as well as the risks associated with the medicinal use of opioids.” 

His paper is heavily researched and includes over 200 footnotes, including several PNN articles that debunk the narrative about opioid misuse being common. 

Bumpus says his paper is important for administrators, policymakers, and lawmakers to read, “so that mistakes of the past are not repeated, making sure that ill-conceived laws and policies are not put in place that do more harm than good.”

Bumpus is correct, of course, and his message is urgent. Now the medical community and policymakers just need to actually listen to him. 

Cactus-Like Plant Shows Promise as Treatment for Intractable Cancer Pain

By Pat Anson

Throughout history, humans have often turned to plants and herbs for pain relief. Poppy plants gave us opium, aspirin was derived from willow trees, and peppermint oil is used to relieve everything from migraines to joint pain. Turmeric, ginger, lavender, eucalyptus and capsaicin are staples in many topical analgesics.

Researchers at the National Institutes of Health (NIH) say a cactus-like shrub native to Morocco also shows promise as a treatment for severe cancer pain and other types of intractable pain.

In a small pilot study recently published in the journal NEJM Evidence, they reported that injections of resiniferatoxin (RTX), a molecule derived from resin spurge (Euphorbia resinifera), provided durable pain relief to patients with terminal end-stage cancer.

"The effects are immediate," lead author Andrew Mannes, MD, chief of the NIH Clinical Center Department of Perioperative Medicine, said in a press release. "This is a potential new therapy from a new family of drugs that gives people with severe cancer pain an opportunity to return some normality to their lives."

The study involved 19 patients with terminal end-stage cancer who did not get adequate pain relief from opioids and other pharmaceutical drugs. But after a single injection of RTX, their worst pain intensity fell by 38% and their use of opioids by 57%. Quality of life also improved, allowing the patients to reengage with family and friends in their final days.

NIH scientists believe RTX has the potential to treat other pain conditions, including other types of cancer pain, neuropathy, post-surgical pain, trigeminal neuralgia, and chronic nerve pain caused by chemotherapy.

"Targeting specific nerves brings many pain disorders into the range of RTX and allows physicians to tailor the treatment to the patient's pain problem. This interventional approach is a simple path to personalized pain medicine," said senior author Michael Iadarola, PhD, a research scientist in the NIH Clinical Center Department of Perioperative Medicine.

RTX acts similarly to capsaicin, the active molecule in chili pepper, by numbing nerve fibers in damaged tissue and blocking them from sending pain signals to the brain. RTX enters the TRPV1 ion channel in the peripheral nervous system, allowing an overload of calcium to flood into the nerve fiber. Patients are still able to feel mild sensations like touch, pressure and pin pricks, but more severe pain signals are blocked.

"Basically, RTX cuts the pain-specific wires connecting the body to the spinal cord, but leaves many other sensations intact," Iadarola said. "These TRPV1 neurons are really the most important population of neurons that you want to target for effective pain relief."

"What makes this unique from all the other things that are out there is that it is so highly selective," Mannes said. "The only thing it seems to take out is heat sensation and pain."

People in North Africa knew this thousands of years ago. The first written record of Euphorbia resinifera being used for pain control dates back to the time of the Roman Emperor Augustus, when dried latex from the plant was used as medicine.

The NIH is planning further studies of RTX in clinical trials.

OxyContin Fueled the Opioid Crisis, But Not How You Might Think

By Crystal Lindell

Attorneys General from 55 U.S. states and territories recently accepted a $7.4 billion settlement with Purdue Pharma and the Sackler family, potentially ending over a decade of legal wrangling over the company’s role in the opioid crisis.  

But much of the media coverage still doesn’t seem to grasp what Purdue Pharma actually did wrong with its marketing of OxyContin. Purdue Pharma’s original sin was not flooding the market with too many OxyContin pills – it was too few.

OxyContin’s share of the opioid market was never more than 4 percent. That small share, however, was magnified by higher dose pills, which made OxyContin more likely to be misused. 

The company drove misuse by claiming that OxyContin pills lasted for 12 hours. In reality, they only lasted 4-6 hours. I know, because I’ve been on them myself for chronic pain.

This is how the Los Angeles Times described Purdue’s marketing campaign in 2016: 

“Purdue tells doctors to prescribe stronger doses, not more frequent ones, when patients complain that OxyContin doesn’t last 12 hours. That approach creates risks of its own. Research shows that the more potent the dose of an opioid such as OxyContin, the greater the possibility of overdose and death."

So if a patient wasn’t getting steady relief from two 10mg OxyContin a day, the doctors would be encouraged to up it to two 20mg OxyContin pills a day. In reality, it would have been better to keep the dose at 10 mg and increase the frequency to four pills a day.

Purdue was well aware of the problem. They knew the pills did not last the full 12 hours. But it was OxyContin’s 12-hour dosing regimen that was its main selling point. It was supposed to set it apart from much cheaper opioid options like hydrocodone, morphine and oxycodone. 

Here’s what happened when doctors prescribed more OxyContin pills to give patients relief, according to the LA Times:

“When many doctors began prescribing OxyContin at shorter intervals in the late 1990s, Purdue executives mobilized hundreds of sales reps to ‘refocus’ physicians on 12-hour dosing. Anything shorter ‘needs to be nipped in the bud. NOW!!’ one manager wrote to her staff.”

Purdue then encouraged doctors to prescribe higher dose 80mg pills, because the higher the dose, the more Purdue made off the pills. While the company charged wholesalers about $97 for a bottle of 10mg pills, a bottle of the 80mg version went for $630. 

The company also based the commissions and performance evaluations for its sales team on the proportion of high-dose pills they sold. 

‘The Dose Makes the Poison’

Over 500 years ago, Swiss physician Paracelsus coined the phrase, “The dose makes the poison.” For Purdue Pharma, that was especially true. It was the high doses at long intervals that made OxyContin so dangerous.

Patients would go through cycles of withdrawal as their high doses wore off early, or they would just take a few extra pills each day. That meant they would run out of their prescription early, leaving them to go through days or even weeks of withdrawal. 

And make no mistake, even short intervals of withdrawal from 80mg OxyContin would make anyone feel like hell. God forbid you run out early and have to go through that. It’s the perfect recipe for driving patients to seek other sources of relief, whether that means buying pills from someone else or buying street opioids. 

Understanding that the root cause of OxyContin’s danger was not that doctors were prescribing too many pills, but prescribing too few of them challenges the popular narrative of how the opioid crisis started.  

The actual problem was not that doctors were treating pain with opioids. They were treating pain with opioids at the wrong intervals. 

Media coverage of Purdue still often frames OxyContin as the same as every other opioid though. But OxyContin isn’t fentanyl and it’s not hydrocodone, either.

Low and frequent doses of hydrocodone are relatively safe for the vast majority of patients. Which makes sense, since the reason OxyContin led some patients to misuse was because it was literally the opposite: High doses taken infrequently. 

That message seems to get lost in current opioid-phobia coverage. Just last week, the LA Times ran a column headlined, “Surgeons give patients too many opioids. A few simple steps could curb excess prescribing”

The column is authored by Zachary Wagner, PhD, a health economist at USC, and Craig Fox, PhD, a psychology professor at UCLA who specializes in studying behavioral risk. Neither of them are medical doctors.

In their op/ed, Wagner and Fox spread the misinformation that it’s leftover post-op pills that are driving opioid deaths. They think surgeons should be encouraged to prescribe fewer opioids. 

“If we could get surgeons to prescribe only the number of pills patients need for their own use, this could greatly reduce the number of excess pills available for diversion and misuse,” they wrote. 

This is dangerous and misleading. Opioids are so difficult to get today that pain patients are far more likely to hoard their “excess pills” than to sell or divert them. Opioid diversion rates are quite low, according to the DEA, which estimates less than half of one percent of oxycodone (0.493%) and hydrocodone (0.379%) are used by someone they are not intended for. 

Do surgeons really need lectures from economists and psychology professors about what they should prescribe?

I have seen first-hand how many surgeons already give post-op patients a regimen of only ibuprofen or acetaminophen due to opioid-phobia laws and regulations. Providing adequate post-op pain relief isn’t just the ethical thing to do, it’s also important for the healing process and to prevent acute pain from becoming chronic.. 

The bottom line is that pain refuses to be ignored. People will find ways to treat it, regardless of whether or not their doctor helps them. Simply refusing to give people opioids won’t solve anything. It will, however, drive people to street drugs or to self-medicate with alcohol and other substances. 

If doctors actually want to help patients, they should still be prescribing low-dose opioids, which are relatively safe. And they should prescribe high-dose opioids to people who really need them, just at realistic intervals.

Purdue Pharma’s sins were real – but letting that justify complete bans on pain treatment only results in more suffering, not less.

Dose and Type of Opioid May Increase Risk of Constipation

By Pat Anson

Constipation is one of the most common – yet least talked about – side effects of opioid pain medication. About 80% of patients on daily opioid therapy experience constipation, even when taking laxatives, which can severely impact quality of life and sleep.

But talking about constipation brings little sympathy and often starts a round of potty jokes. When AstraZeneca aired a commercial during the 2016 Super Bowl promoting its opioid induced constipation (OIC) drug, the ad was greeted with derision..

“The Super Bowl is known for inspiring lots of eating and lavish spreads of food. So why would advertisers pay millions to air ads focusing on constipation?” asked Eric Deggans of National Public Radio.

“Was that really an ad for junkies who can’t sh**? America, I luv ya but I just can’t keep up,” comedian Bill Maher wrote on Twitter.  

All jokes aside, constipation really is a health problem. Which makes a new study at the UK’s University of Manchester all the more valuable because it identifies which opioid painkillers are most likely to be associated with constipation and which ones are not.

"Constipation is a frequent adverse event associated with opioid medications that can have a considerable impact on patients' quality of life,” says lead author Meghna Jani, PhD, an epidemiologist and Senior Clinical Lecturer at The University of Manchester. “Opioid-induced constipation has also been associated with longer hospital stays, higher hospital costs, and increased emergency department visits."

Jani and her colleagues analyzed hospital health records for over 80,000 non-cancer patients on opioids in England between 2009 and 2020. About 8% suffered from constipation severe enough to require an enema or suppository.

The study findings, recently published in BMC Medicine, show that morphine, oxycodone, fentanyl and combination opioids were associated with a significantly higher risk of severe constipation compared to codeine. Tramadol and buprenorphine had the least amount of constipation risk.

Tramadol and buprenorphine have different mechanisms of action than other opioids, which may explain their lower risk, while codeine and tramadol are considered less potent opioids.

The risk of constipation was also found to be dose-dependent. Patients taking less than 50 morphine milligram equivalents (MME) a day had the lowest risk of constipation, while those taking 50 to 120 MME daily had a risk twice as high. Fifty MME per day is roughly equal to taking either 50mg of morphine or 33 mg of oxycodone each day.

The Faculty of Pain Medicine of the Royal College of Anaesthetists says the dose above which opioid harms likely outweigh their benefits is 120 MME per day. Guidance in the U.S. and Canada is more cautious, recommending that opioid doses be kept at or below 90 MME.

This is believed to be largest study of its kind to evaluate constipation risk based on types of opioids, and one of the first to assess the impact of doses. Researchers say previous estimates of constipation rates probably under-represent their true prevalence, because constipation is often not seen as a serious issue and may not be coded in medical records. Patients may also be reluctant to openly talk about their bowel habits with a healthcare provider.

"Previously, we didn't know enough about the risk associated with specific opioids, given the different ways they act on the body, as well as the effect of daily dose,” said Jani. "This study will allow clinical prescribers and patients to make better shared decisions about what pain relief is best for them, to minimize the risks of this side effect of opioids, and thus improve patients' quality of life.

"If patients need to be on opioids, we urge prescribers to be cautious with opioid dosing, and aim for the lowest effective dose to manage pain while mitigating the risk of constipation and other side effects."

A Non-Alcoholic Drink Can Help You Relax, Socialize and May Even Relieve Pain

By Madora Pennington

I am going for a month without drinking, not because I have a problem with alcohol or because alcohol is interfering with my life. I don't and it isn't.

I just got back from a long vacation, which included an 8-day all-inclusive cruise. We wanted to get our money’s worth. After weeks of drinking every day, it seemed only sensible to take a full break from alcohol. No one would argue that so much drinking is healthy.

I am not alone. You may have heard about the “sober curious” — those who abstain to see what socializing, stress, and life itself is like without alcohol. Young adults, overall, are drinking less alcohol. These trends are fueling the demand for non-alcoholic, yet interesting drinks that seem sophisticated or reminiscent of a cocktail.

But is there a non-alcoholic drink that also helps you relax and socialize? I found a company, Sentia Spirits, that makes beverages that enhance your body’s production of GABA

Don’t confuse GABA (gamma-aminobutyric acid) with the nerve pain medication gabapentin (Neurontin). GABA is a naturally occurring neurotransmitter that sends signals in the brain and spinal cord, while gabapentin is a synthetic variation of GABA. The medication acts similarly as GABA, but tends to cause many unwanted side effects. Benzodiazepines, SSRI antidepressants, muscle relaxers, and other drugs also affect GABA in the body.

Sentia’s beverages contain herbs and botanicals that improve mood, focus, calmness, and energy. Their concoctions taste more like bitters than a mocktail, but certainly provide an interesting experience for the palate.

I found them to be subtly relaxing, without the impairment of an alcohol-induced buzz.

GABA itself is also available in supplements that people take to relax and improve sleep. It may also help relieve pain. When GABA binds to pain receptors, it reduces the transmission of pain signals, potentially providing relief from various types of physical discomfort.

SENTIA SPIRITS

Research has found that low levels of GABA make it harder to keep negative emotions such as fear, anxiety and depression in check, and may also worsen chronic pain. As PNN has reported, Dr. Forest Tennant recommends GABA supplements for patients with intractable pain "to force damaged nerve tissue to correctly function and relieve pain.”  

As far as reasons for abstaining, alcohol worsens depression. And people with alcohol use disorder often have chronic pain, which means they could be self-medicating.

Using supplemental GABA or medications that promote it could be a useful strategy in managing the spiral of chronic pain on the body and brain. Many sources suggest taking GABA on an empty stomach to give it a better chance of reaching the brain.

Limiting alcohol intake might also be a wise choice for anyone. Certainly, finding ways to diminish stress and improve sleep should be part of pain management.

Sentia costs about $40 for a 500ml bottle, which is enough for 20 shot-sized servings. If you don't want it straight or want to make it look like a cocktail, you can mix it with tonic water.

Talk to your healthcare provider about your pain control regimen and how to improve it before taking GABA or any supplement.

I enjoyed my time of sobriety very much. I thought I would miss drinking, but did not. The sleepiness and haziness from a glass of wine is stronger than I realized, and it doesn’t make socializing more fun for me. I ended my sober curious time with a resolve to drink less overall.

Will FDA’s New Review Process Sell Drug Approvals to the Highest Bidder?

By Crystal Lindell

The U.S. Food and Drug Administration has launched a new speedy review process for new medications, dubbed the Commissioner’s National Priority Voucher (CNPV) program. 

The FDA claims the program will speed up the approval process for pharmaceutical companies looking to get a new drug on the market – but it remains unclear whether it is based on a need for the drug, its effectiveness, or how much companies are willing to pay for the privilege of early approval..

The FDA said the CNPV program will shorten the review time to 1-2 months, compared to the typical 10-12 months it usually takes after a company’s final drug application.

They’ll accomplish this by allowing for a “team-based review.” This differs from the current process, where a drug application is “sent to numerous FDA offices” to give them a chance to weigh-in.

The program will even allow companies to submit the lion’s share of the drug application before a clinical trial is complete, according to FDA Commissioner Marty Makary, MD.

“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” Makary said. 

Neither the FDA press release about the new program or its "Frequently Asked Questions" page specify how much this new program will cost companies interested in participating. 

We can gain some frame of reference by looking at what the existing Priority Review and Priority Review Voucher costs for companies, as well as what their true value is. 

While the FDA charges companies about $2.5 million for those vouchers, according to the General Accounting Office (GAO) they have been resold on the secondary market for as much as $350 million. The GAO found that of the 31 vouchers awarded by the FDA between 2009 and 2019, over half (17) were sold to another drug company.

The new vouchers cannot be transferred to other companies as of now, but with so much money at stake, you have to wonder if there will be a valuable aftermarket for them.

Even if the new vouchers themselves are reasonably priced, my guess is that they will be more likely to go to companies that donate money to elected officials or are politically favored. 

The FDA says that in the first year of the program it will give a limited number of vouchers to companies “aligned with U.S. national priorities,” which include “unmet public health needs” and increased domestic drug manufacturing. But then they also say the vouchers “can be applied to drugs in any area of medicine.”

In other words, basically any medication would qualify. There’s not much else to explain just how vague the criteria is for receiving the vouchers.  

And if any medication would qualify for the new vouchers, it makes sense that the ultimate qualification would be what companies are willing to pay to get them. 

Under the current voucher system, the GAO found there is “no obligation to make the approved drug available at an affordable price,” so companies are free to limit access and charge whatever they want. The new voucher system also has no requirement that new drugs will be affordable or accessible. 

While I do understand the need for more efficiencies in the drug review process, when those efficiencies are applied unevenly, it inevitably invites corruption. And the last thing we need when it comes to prescription medications and healthcare in our country is more corruption. 

My concern is that the drugs getting speedy review won’t actually be the ones that are in the public’s best interests, but rather the ones that best serve the interests of our elected officials and the drug companies themselves. 

And when it comes to prescription medications, we all know that what’s best for politicians and the pharmaceutical industry is not what’s best for patients.

A Pained Life: Stop Torturing Us

By Carol Levy

For many chronic pain conditions, such as Complex Regional Pain Syndrome, trigeminal neuralgia and Ehlers Danlos Syndrome, a major aspect is the spontaneity of pain attacks. They can come at any time and without warning.

Not being able to anticipate a pain flare may sound familiar to you. It causes psychological stress, keeping you in a constant state of fear and anxiety. The lack of predictability deprives a person of any sense of normalcy or control over their situation, causing helplessness and despair.

That often leads to other health problems and interrupts the sleep cycle, causing fatigue, disorientation and even cognitive decline. 

Where did this description of chronic pain come from?

It is actually a description (with some word modification) of torture and how disruptive it can be to a person. It’s striking how similar chronic pain and torture can be.

Having chronic pain is torture to me in an abstract way: I have pain. I can't find a way to stop it. I suffer as a result.

Like pain, torture is worse when it arrives unexpectedly and you have no way to stop it. You may be feeling okay, when suddenly a blitzkrieg of pain invades. You have no control or defense, and have no choice but to wait it out, cowering under the covers waiting for it to pass.

The Center for Victims of Torture writes this about using unpredictability as a torture technique:

“Randomizing torture makes it even more psychologically damaging and ethically problematic, as it deprives the victim of any control or predictability.”

Too often doctors miss the ethical implications of the effect of the pain on us, much less when one aspect of it is the unpredictability. The need for them to understand it is a necessary component of taking care of us and our needs --- what a physician, in the truest sense of the word, should do.

Too many of them, even those who claim “pain management” as their specialty, seem to get tired of listening as we explain the various ways our pain manifests. Most pain conditions don’t have a nice clean orderly way of detail.

It can be torturous to deal with the medical profession and its reluctance to accept our stories about living with chronic pain. It is harder still when a patient has the additional spontaneity of pain, being repeatedly physically and psychologically bombarded by it, and their defenses on the verge of being destroyed.

Doctors don’t seem to be able to understand this on their own. We may come to them psychologically tattered because of the pain. Those of us with spontaneous pain may come to them appearing very emotionally fragile.

As hard as it is, as difficult our lives already are due to the pain, we may have to be the ones to teach them, to help them to understand why we are so torn and battered. At the end of the day we need to tell them: “Please, listen to me. Understand me. Please, don’t be another level of torture.”

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here. 

People Who Live in Rural Areas Have More Pain and Less Access to Treatment

By Crystal Lindell 

A new study by researchers at the University of Texas at Arlington found that people living in rural areas have significantly higher rates of chronic pain than those who live in big cities. They’re also at a big disadvantage when it comes to getting their pain treated.

As a rural resident myself for the last 11 years, I have some thoughts as to why this might be. I think one of the causes may be a little different than what researchers often assume. 

The study used data from a national health survey of over 10,000 people in 2019, and then followed up with them a year later in 2020. 

Respondents were split into four pain categories; those with no pain, nonchronic acute pain, chronic pain, and high-impact chronic pain (HICP), which is pain that significantly impacts daily life.

Participants were then assigned to one of four urban-rural metro areas based on where they live: Large Central Metro (big cities with at least one million people), Large Fringe Metro, Medium and Small Metro, and Non-Metropolitan (Rural).

The chart below shows that the highest rates of chronic pain (27.8%) and HICP (10.4%) were found in rural non-metropolitan areas. Pain rates were progressively lower in metro areas with more people. 

Notably, 43.1% of the people living in big cities had “no pain,” while only 34% of those in rural areas were pain free. That’s a statistically big difference.

The Journal of rural health

“We already know about the rural-urban gap in mortality and life expectancy,” said Feinuo Sun, PhD, an assistant professor of kinesiology at UT Arlington and lead author of the study in The Journal of Rural Health.

“But when you look at pain, especially chronic pain, it becomes clear that rural residents face additional burdens.”

Sun and her colleagues say their findings highlight the rural disadvantage that exists in pain development and treatment. Due to health care shortages in rural areas, people have limited access to pain treatment and lower quality services.

They also found that the percentages of people transitioning from milder pain conditions in 2019 to more severe ones in 2020 were highest in rural areas. Even when starting from the same baseline pain status, people in rural areas fared worse after one year compared to those in urban areas.

“Without early intervention, (chronic pain) can have serious long-term consequences, including premature mortality. That's why targeted outreach and early pain management strategies are so important," said Sun.

Rural residents are also more likely to work physically demanding jobs and experience higher poverty rates, both of which contribute to chronic pain.

Those are definitely contributing factors. People who live near me in northern Illinois tend have more physically demanding work, such as farming and construction, and they have a much harder time accessing good healthcare. 

Personally, I have to drive almost two hours each way just to see my primary care physician, because I have to get more complex pain care. That’s where the closest university hospital is to my house. 

Lower Cost of Living

But there’s another reason that is easy to overlook if you don’t live out here: Rural areas are much cheaper than urban ones. 

That’s literally the reason I choose to live in a rural area. The rent in my area is astronomically cheaper than nearby metro areas, and much less compared than a big city like Chicago. 

If you're managing a life with chronic pain, you’re going to be less likely to be able to work and you’re also going to be more likely to spend more of your income on medical expenses. You’ll need a cheaper place to live.

Additionally, many people move out to rural areas like mine because it’s easier to live on Social Security, disability or pensions. None of those benefits increase based on your local cost of living, so it makes sense to live in a rural area where the same amount of money can go much further. 

So it’s not always physically demanding labor that causes more pain in rural areas. It’s being in chronic pain that makes it more likely you’ll move to or stay in a rural community.

Of course, the researchers also found an association with opioid medication, because what would a pain study be in 2025 if the authors didn’t link it in some way to opioids?

The UT researchers think that  “elevated pain levels, along with fewer treatment options, may help explain the heavier reliance on opioids” in rural communities. They’re already working on a follow-up study to examine disparities in pain care. I can already tell them some of the answers they seek. 

People in rural areas are more likely to take opioids for pain care because they are incredibly cheap and accessible. Even if a rural area doesn’t have a local pharmacy, you still have access to mail-order pharmacies. 

And if a rural area doesn’t have a physical therapist, acupuncturist or a massage therapist, there are few alternatives besides opioids. Opioids also require fewer appointments with providers, which are at a premium when doctors are 2 hours away or more.

In the end, geography shapes both our pain and standard of living. Rural areas need better access to healthcare and more populated areas need lower costs of living. We can help people, we just have to work in both directions.  

Former CDC Commissioner: Kratom Has ‘Low Abuse Potential’

By Pat Anson

The U.S. Food and Drug Administration has a conflicted and contentious history with kratom, the herbal supplement used by millions of Americans to self-treat their pain, anxiety, and depression.  

Kratom has been used for centuries in southeast Asia as a natural stimulant and pain reliever, but only in the past decade has it become widely available in the United States -- over the strong objections of the FDA.

In 2016, the FDA joined with the DEA in proposing that kratom be classified as an illegal Schedule I controlled substance due to its abuse potential, a request that was later withdrawn due to a public outcry.

That setback didn’t stop then-FDA Commissioner Scott Gottlieb, MD, from launching a public relations campaign demonizing and mischaracterizing kratom as an addictive “opioid.” Gottlieb cited FDA research that an Assistant Secretary for Health later called “embarrassingly poor evidence & data.”

To improved its data, last year the FDA said it would conduct a new study on the risks and safety of kratom, and then abruptly cancelled it without explanation, claiming kratom has a “chemical affinity” with opioids and should not be used to treat medical conditions. “The use of this substance, that has yet to be tested and determined safe for use in human population by the Agency, is a significant concern,” the FDA said.

The claim that kratom “has yet to be tested and determined safe” is misleading, because the FDA had just completed a pilot study showing that kratom is relatively safe, even at doses as high as 12 grams -- the equivalent of taking 24 capsules of kratom leaf powder within five minutes.   

“In 2024, the FDA completed a single ascending-dose clinical trial examining ground kratom leaf in experienced users. The results were illuminating: participants experienced no serious adverse events at doses up to 12 grams, with side effects limited to mild nausea and pupil constriction. Crucially, subjective ‘drug liking’ scores never reached statistical significance compared to placebo, indicating low abuse potential for natural leaf,” former CDC Commissioner Robert Redfield, MD, said in an op/ed published today in The Hill.

Redfield’s comment is notable, because the FDA itself has never had much to say about its 2024 study and still hasn’t posted the final results. According to the American Kratom Association, FDA researchers were "profoundly disappointed” at the lack of adverse events associated with kratom, as that doesn’t square with the agency’s long-held public position on kratom.

Redfield may be reassured of the safety of natural kratom, but he thinks the federal government should take emergency action to ban the import and sale of synthetic kratom extracts, which have elevated levels of 7-hydroxymitragynine, an alkaloiid that is present in only minute amounts in the natural leaf. Kratom extracts have been associated with serious adverse events and overdoses.  

Redfield says synthetic kratom has “pharmaceutical-grade opioid chemistry” and should be taken off the market immediately. But he thinks natural kratom is relatively safe, and cites the 2024 study as evidence.

“This clinical evidence establishes a critical scientific baseline: natural kratom leaf, when used as it has been for centuries, presents a markedly different risk profile than the synthetic products flooding American markets,” Redfield wrote. “This is not about banning kratom. Full spectrum kratom, used responsibly, appears to have acceptable safety margins based on FDA’s own clinical data. This is about preventing synthetic opioids from hiding behind botanical names.”

The FDA still has “serious safety concerns” about natural kratom, but has little evidence to back them up and is apparently slow-walking research. Only two federally-funded kratom studies are currently recruiting participants. One would study the effects of natural kratom and the potential for withdrawal, while the second trial would study the effects of kratom extracts.

Both studies are small and won’t be completed until 2028 —- over a decade after the agency tried to get kratom banned nationwide.

Seniors Should Be Cautious Using Gummies and Other Cannabis Products

By Paula Span, KFF Health News

Benjamin Han, a geriatrician and addiction medicine specialist at the University of California-San Diego, tells his students a cautionary tale about a 76-year-old patient who, like many older people, struggled with insomnia.

“She had problems falling asleep, and she’d wake up in the middle of the night,” he said. “So her daughter brought her some sleep gummies” — edible cannabis candies.

“She tried a gummy after dinner and waited half an hour,” Han said.

Feeling no effects, she took another gummy, then one more — a total of four over several hours.

Han advises patients who are trying cannabis to “start low; go slow,” beginning with products that contain just 1 or 2.5 milligrams of tetrahydrocannabinol, or THC, the psychoactive ingredient that many cannabis products contain. Each of the four gummies this patient took, however, contained 10 milligrams.

The woman started experiencing intense anxiety and heart palpitations. A young person might have shrugged off such symptoms, but this patient had high blood pressure and atrial fibrillation, a heart arrhythmia. Frightened, she went to an emergency room.

Lab tests and a cardiac work-up determined the woman wasn’t having a heart attack, and the staff sent her home. Her only lingering symptom was embarrassment, Han said. But what if she’d grown dizzy or lightheaded and was hurt in a fall? He said he has had patients injured in falls or while driving after using cannabis. What if the cannabis had interacted with the prescription drugs she took?

“As a geriatrician, it gives me pause,” Han said. “Our brains are more sensitive to psychoactive substances as we age.”

Unclear Benefits

Thirty-nine states and the District of Columbia now allow cannabis use for medical reasons, and in 24 of those states, as well as the district, recreational use is also legal. As older adults’ use climbs, “the benefits are still unclear,” Han said. “But we’re seeing more evidence of potential harms.”

A wave of recent research points to reasons for concern for older users, with cannabis-related emergency room visits and hospitalizations rising, and a Canadian study finding an association between such acute care and subsequent dementia.

Older people are more apt than younger ones to try cannabis for therapeutic reasons: to relieve chronic pain, insomnia, or mental health issues, though evidence of its effectiveness in addressing those conditions remains thin, experts said.

In an analysis of national survey data published June 2 in the medical journal JAMA, Han and his colleagues reported that “current” cannabis use (defined as use within the previous month) had jumped among adults age 65 or older to 7% of respondents in 2023, from 4.8% in 2021. In 2005, he pointed out, fewer than 1% of older adults reported using cannabis in the previous year.

What’s driving the increase? Experts cite the steady march of state legalization — use by older people is highest in those states — while surveys show that the perceived risk of cannabis use has declined.

One national survey found that a growing proportion of American adults — 44% in 2021 — erroneously thought it safer to smoke cannabis daily than cigarettes. The authors of the study, in JAMA Network Open, noted that “these views do not reflect the existing science on cannabis and tobacco smoke.”

The cannabis industry also markets its products to older adults. The Trulieve chain gives a 10% discount, both in stores and online, to those it calls “wisdom” customers, 55 or older. Rise Dispensaries ran a yearlong cannabis education and empowerment program for two senior centers in Paterson, New Jersey, including field trips to its dispensary.

The industry has many satisfied older customers. Liz Logan, 67, a freelance writer in Bronxville, New York, had grappled with sleep problems and anxiety for years, but the conditions grew particularly debilitating two years ago, as her husband was dying of Parkinson’s disease. “I’d frequently be awake until 5 or 6 in the morning,” she said. “It makes you crazy.”

Looking online for edible cannabis products, Logan found that gummies containing cannabidiol, known as CBD, alone didn’t help, but those with 10 milligrams of THC did the trick without noticeable side effects. “I don’t worry about sleep anymore,” she said. “I’ve solved a lifelong problem.”

But studies in the United States and Canada, which legalized nonmedical cannabis use for adults nationally in 2018, show climbing rates of cannabis-related health care use among older people, both in outpatient settings and in hospitals.

In California, for instance, cannabis-related emergency room visits by those 65 or older rose, to 395 per 100,000 visits in 2019 from about 21 in 2005. In Ontario, acute care (meaning emergency visits or hospital admissions) resulting from cannabis use increased fivefold in middle-aged adults from 2008 to 2021, and more than 26 times among those 65 and up.

“It’s not reflective of everyone who’s using cannabis,” cautioned Daniel Myran, an investigator at the Bruyère Health Research Institute in Ottawa and lead author of the Ontario study. “It’s capturing people with more severe patterns.”

But since other studies have shown increased cardiac risk among some cannabis users with heart disease or diabetes, “there’s a number of warning signals,” he said.

For example, a disturbing proportion of older veterans who currently use cannabis screen positive for cannabis use disorder, a recent JAMA Network Open study found.

As with other substance use disorders, such patients “can tolerate high amounts,” said the lead author, Vira Pravosud, a cannabis researcher at the Northern California Institute for Research and Education. “They continue using even if it interferes with their social or work or family obligations” and may experience withdrawal if they stop.

Among 4,500 older veterans (with an average age of 73) seeking care at Department of Veterans Affairs health facilities, researchers found that more than 10% had reported cannabis use within the previous 30 days. Of those, 36% fit the criteria for mild, moderate, or severe cannabis use disorder, as established in the Diagnostic and Statistical Manual of Mental Disorders.

VA patients differ from the general population, Pravosud noted. They are much more likely to report substance misuse and have “higher rates of chronic diseases and disabilities, and mental health conditions like PTSD” that could lead to self-medication, she said.

Current VA policies don’t require clinicians to ask patients about cannabis use. Pravosud thinks that they should.

Moreover, “there’s increasing evidence of a potential effect on memory and cognition,” said Myran, citing his team’s study of Ontario patients with cannabis-related conditions going to emergency departments or being admitted to hospitals.

Compared with others of the same age and sex who were seeking care for other reasons, research shows these patients (ages 45 to 105) had 1.5 times the risk of a dementia diagnosis within five years, and 3.9 times the risk of that for the general population.

Even after adjusting for chronic health conditions and sociodemographic factors, those seeking acute care resulting from cannabis use had a 23% higher dementia risk than patients with noncannabis-related ailments, and a 72% higher risk than the general population.

None of these studies were randomized clinical trials, the researchers pointed out; they were observational and could not ascertain causality. Some cannabis research doesn’t specify whether users are smoking, vaping, ingesting or rubbing topical cannabis on aching joints; other studies lack relevant demographic information.

“It’s very frustrating that we’re not able to provide more individual guidance on safer modes of consumption, and on amounts of use that seem lower-risk,” Myran said. “It just highlights that the rapid expansion of regular cannabis use in North America is outpacing our knowledge.”

Still, given the health vulnerabilities of older people, and the far greater potency of current cannabis products compared with the weed of their youth, he and other researchers urge caution.

“If you view cannabis as a medicine, you should be open to the idea that there are groups who probably shouldn’t use it and that there are potential adverse effects from it,” he said. “Because that is true of all medicines.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Kennedy’s HHS Sent Congress ‘Junk Science’ To Defend Vaccine Changes

By Jackie Fortiér, KFF Health News

A document the Department of Health and Human Services sent to lawmakers to support Secretary Robert F. Kennedy Jr.’s decision to change U.S. policy on covid vaccines cites scientific studies that are unpublished or under dispute and mischaracterizes others.

One health expert called the document “willful medical disinformation” about the safety of covid vaccines for children and pregnant women.

“It is so far out of left field that I find it insulting to our members of Congress that they would actually give them something like this. Congress members are relying on these agencies to provide them with valid information, and it’s just not there,” said Mark Turrentine, a professor of obstetrics and gynecology at Baylor College of Medicine.

Kennedy, who was an anti-vaccine activist before taking a role in the Trump administration, announced May 27 that the Centers for Disease Control and Prevention would no longer recommend covid vaccines for pregnant women or healthy children, bypassing the agency’s formal process for adjusting its vaccine schedules for adults and kids.

The announcement, made on the social platform X, has been met with outrage by many pediatricians and scientists.

The HHS document meant to support Kennedy’s decision, obtained by KFF Health News, was sent to members of Congress who questioned the science and process behind his move, according to one federal official who asked not to be identified because he wasn’t authorized to discuss the matter publicly.

The document has not been posted on the HHS website, though it is the first detailed explanation of Kennedy’s announcement from the agency.

Titled “Covid Recommendation FAQ,” the document distorts some legitimate studies and cites others that are disputed and unpublished, medical experts say.

HHS director of communications Andrew Nixon told KFF Health News, “There is no distortion of the studies in this document. The underlying data speaks for itself, and it raises legitimate safety concerns. HHS will not ignore that evidence or downplay it. We will follow the data and the science.”

HHS did not respond to a request to name the author of the document.

‘RFK Jr.’s Playbook’

One of the studies the HHS document cites is under investigation by its publisher regarding “potential issues with the research methodology and conclusions and author conflicts of interest,” according to a link on the study’s webpage.

“This is RFK Jr.’s playbook,” said Sean O’Leary, chair of the Committee on Infectious Diseases for the American Academy of Pediatrics and an assistant professor of pediatrics at the University of Colorado School of Medicine. “Either cherry-pick from good science or take junk science to support his premise — this has been his playbook for 20 years.”

Another study cited in the document is a preprint that has not been peer-reviewed. Under the study’s title is an alert that “it reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.” Though the preprint was made available a year ago, it has not been published in a peer-reviewed journal.

The FAQ supporting Kennedy’s decision claims that “post-marketing studies” of covid vaccines have identified “serious adverse effects, such as an increased risk of myocarditis and pericarditis” — conditions in which the heart’s muscle or its covering, the pericardium, suffer inflammation.

False claims that the 2024 preprint showed myocarditis and pericarditis only in people who received a covid vaccine, and not in people infected with covid, circulated on social media. One of the study’s co-authors publicly rejected that idea, because the study did not compare outcomes between people who were vaccinated and those infected with the covid virus. The study also focused only on children and adolescents.

The HHS document omitted numerous other peer-reviewed studies that have shown that the risk of myocarditis and pericarditis is greater after contracting covid for both vaccinated and non-vaccinated people than the risk of the same complications after vaccination alone.

O’Leary said that while some cases of myocarditis were reported in vaccinated adolescent boys and young men early in the covid pandemic, the rates declined after the two initial doses of covid vaccines were spaced further apart.

Now, adolescents and adults who have not been previously vaccinated receive only one shot, and myocarditis no longer shows up in the data, O’Leary said, referring to the CDC’s Vaccine Safety Datalink. “There is no increased risk at this point that we can identify,” he said.

In two instances, the HHS memo makes claims that are actively refuted by the papers it cites to back them up. Both papers support the safety and effectiveness of covid vaccines for pregnant women.

The HHS document says that another paper it cites found “an increase in placental blood clotting in pregnant mothers who took the vaccine.” But the paper doesn’t contain any reference to placental blood clots or to pregnant women.

“I’ve now read it three times. And I cannot find that anywhere,” said Turrentine, the OB-GYN professor.

If he were grading the HHS document, “I would give this an ‘F,’” Turrentine said. “This is not supported by anything and it’s not using medical evidence.”

While members of Congress who are physicians should know to check references in the paper, they may not take the time to do so, said Neil Silverman, a professor of clinical obstetrics and gynecology who directs the Infectious Diseases in Pregnancy Program at the David Geffen School of Medicine at UCLA.

“They’re going to assume this is coming from a scientific agency. So they are being hoodwinked along with everyone else who has had access to this document,” Silverman said.

The offices of three Republicans in Congress who are medical doctors serving on House and Senate committees focused on health, including Sen. Bill Cassidy (R-La.), did not respond to requests for comment about whether they received the memo. Emily Druckman, communications director for Rep. Kim Schrier (D-Wash.), a physician serving on the House Energy and Commerce Committee, confirmed that Schrier’s office did receive a copy of the document.

“The problem is a lot of legislators and even their staffers, they don’t have the expertise to be able to pick those references apart,” O’Leary said. “But this one — I’ve seen much better anti-vaccine propaganda than this, frankly.”

C.J. Young, deputy communications director for the House Energy and Commerce Committee, confirmed that Democratic staff members of the committee received the document from HHS. In the past, he said, similar documents would help clarify the justification and scope of an administration’s policy change and could be assumed to be scientifically accurate, Young said.

“This feels like it’s breaking new ground. I don’t think that we saw this level of sloppiness or inattention to detail or lack of consideration for scientific merit under the first Trump administration,” Young said.

On June 4, Rep. Frank Pallone (D-N.J.) and Schrier introduced a bill that would require Kennedy to adopt official vaccine decisions from the Advisory Committee on Immunization Practices, or ACIP.

Young said the motivation behind the bill was Kennedy’s decision to change the covid vaccine schedule without the input of ACIP’s vaccine experts, who play a key role in setting CDC policies around vaccine schedules and access.

Kennedy announced June 9 on X that he would remove all 17 members of ACIP, citing alleged conflicts of interest he did not detail, and replace them. He announced eight replacements June 11, including people who had criticized vaccine mandates during the covid pandemic.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

KFF would like to speak with current and former personnel from the Department of Health and Human Services or its component agencies who believe the public should understand the impact of what’s happening within the federal health bureaucracy. Please message KFF Health News on Signal at (415) 519-8778 or get in touch here.

5 Cool Things to Help You Endure Summer Heat With Chronic Pain

By Crystal Lindell

As temperatures heat up this summer, it can be difficult to get through hot sunny days when you’re also dealing with chronic pain and chronic illness. 

Weather is such a huge factor in the severity of day-to-day chronic pain levels, and if you’re on certain medications heat can also impact your body in other ways, like skin irritation and ankle swelling. 

Here are 5 things I use to get through the summer months while also dealing with chronic pain and chronic illness. 

Gold Bond Friction Defense Stick

My number one summer survival item is the Gold Bond Friction Defense Stick. I use it on my arms and thighs to prevent the heat and humidity from chaffing my skin if I’m wearing shorts, a tank top, a bathing suit or any light summer clothing. 

And this stuff seriously works! Putting it on after my morning shower makes such a huge difference in my quality of life throughout the summer. 

If you have a long day of walking, or swimming you may need to re-apply a few times, but for most day-to-day activities, I have found that once in the morning is more than adequate. 

Find it on Amazon here.

Compression Socks

Every summer my excessive ibuprofen use combines forces with my Ehler-Danlos Syndrome to make my ankles swell up – especially if the humidity is high.

So I swear by these compression socks, which virtually eliminate that symptom, even after long car rides. I have multiple packs of these in multiple colors, and throughout the summer months, I wear them almost daily. 

No, they aren’t super stylish with shorts, but if you wear them underneath pants, nobody can even tell. 

Find them on Amazon here. 

Light, Airy Pants

Speaking of pants, I tend to prefer them to shorts most of the time, even in the summer months. And these light, airy pants are great for enduring the heat. 

They offer all the comfort of pants, with all the breathability of shorts. I use them as pajamas, as well as pants to wear over my bathing suit at the pool, and even for lounging around during the day.

According to my Amazon order history, I have literally ordered these pants eight times! I have them in every color and even in multiple sizes. They’re also great at enduring weight fluctuations that are common when you’re on a lot of medications and dealing with chronic pain because of how stretchy the waist is. 

But the best things about these pants might be that they have pockets! If you’re familiar with the world of women’s pants, you know just how valuable and rare that feature is! 

Find them on Amazon here. 

Adjustable Fan

Sometimes chronic pain and related medications make us especially sensitive to heat and humidity, but a personal, adjustable fan can be a great way to cope. 

We have this fan in multiple colors, and we use them throughout the summer to direct air flow exactly where we want it. 

It’s relatively quiet for a fan, but it still packs a punch when it comes to cooling you off during the summer months. 

Find it on Amazon here. 

Summer Reading Club

If you’re looking for a comforting summer read, I can’t recommend “Garden Spells” by Sarah Addison Allen enough. It’s a very light, easy read that follows the stories of two sisters who have to navigate common sibling friction with the added stress of coming from a magical family that the whole town thinks is “weird.”

I read it for a book club recently and flew through it in two days. It’s a great light read, even if you’re have a chronic pain flare and can’t get off the couch. It also takes place in the south, and the heat is a common theme, making it perfect for getting into the summer state of mind.

Find it on Amazon here. 

What products do you use to get through the hot and humid summer months while dealing with chronic pain? We’d love to hear your recommendations in the comments below! 

The Pain News Network may make a small commission on items purchased through the links above. 

Should Pharmacists Tell Your Doctor How to Treat Pain?

By Pat Anson

Would you like a pharmacist to consult with your doctor about how to treat your chronic pain before you even see the doctor?

Given all the problems that pain patients already have getting pharmacies to fill their opioid prescriptions, that sounds counter-intuitive. But embedding a pharmacist in doctors’ offices and giving them advice is the premise behind a new article published in the Drug Topics Journal, written by Sarah Schang and Madison Irwin, who both have medical degrees in pharmacy (PharmD).   

They think giving pharmacists a prominent and early voice in your pain care will lead to better treatment and reduce the risk of controlled substances being misused. In their eyes, pharmacists “play key roles in educating other health care professionals and patients about safe and effective chronic pain management.”

Under federal law, pharmacists have a “corresponding responsibility” when filling prescriptions for opioids and other controlled substances – a legal right to refuse to fill prescriptions they consider unusual or improper. Usually that “responsibility” begins at the pharmacy level, but Drs. Schang and Irwin think it should start before prescriptions are even written for chronic pain conditions.

“Despite the high prevalence of chronic pain and its far-reaching consequences, it often has suboptimal management, typically involving a combination of pharmacotherapy that can quickly become complex and require expertise. Pharmacists are uniquely well positioned to provide this expertise and optimize medication management for chronic pain,” they wrote.

“There is an immense need for safe and effective medication management in chronic pain, and pharmacists have a unique role to play in meeting this need.”

Schang and Irwin cite several old pilot studies to support their claims. One study, published in 2018, involved 45 pain patients on high-dose opioids being treated at a large family medicine practice. A few days before their appointments, two pharmacists embedded in the practice reviewed patient charts and pain management plans, and recommended changes to their treating physicians.

Almost always, the recommendations were to taper the patients off opioids, switch to non-opioid analgesics, refer the patients to a pain specialist, and offer them a naloxone prescription to reverse overdoses. Those recommendations were often implemented.        

How did that work out for the patients? According to Schang and Irwin, there was a 14% average decrease in their daily dose of opioids in morphine milligram equivalents (MME), a tapering that was achieved “without impacting pain scores.”  

Is that what happened? Not really. A close look at the study itself shows that the average pain score went up after doses were lowered, from 5.3 before the pharmacists’ intervention to 5.5 afterward, based on a zero to 10 pain scale.

It’s also worth noting that these “high-risk” patients were on relatively high opioid doses before the intervention (135 MMEs daily). Even with the 14% reduction in dose, they were still getting an average of 116 MMEs daily – a dose that’s unattainable for most patients today due to fears about “overprescribing” opioids. Most patients in 2025 get less than 90 MME, in many cases substantially less.

Another pilot study cited by Schang and Irwin dates back to 2016. It involved a community pharmacy in an academic medical center in southern California. Pharmacists there reviewed the treatment plans of 23 patients on high dose opioids and recommended changes in their treatment, such as tapering, regular drug tests, and naloxone.

How the changes impacted the patients’ pain levels was apparently not evaluated, but particular attention was paid to their mental health. The most common problems identified by the pharmacists were “untreated” depression, anxiety, insomnia, and substance misuse.

“Notably, substance misuse was identified in nearly a third of patients, which allowed for subsequent referral to substance use disorder treatment when appropriate. Similar interventions in the community pharmacy setting also demonstrated significant value, with pharmacists identifying unaddressed issues with mood in nearly two-thirds of patients and increasing the uptake of naloxone,” Schang and Irwin wrote.

Being referred to addiction treatment or a psychiatrist probably isn’t the goal of most pain patients, who simply want their pain managed. That would go a long way toward resolving their “unaddressed” mental health issues.

Many pain patients today are already frustrated with pharmacists. They can’t get their opioid prescriptions filled due to opioid rationing, and are tired of the stigma and hostility they often face at pharmacies. The pharmacy industry itself is also going through a major contraction, with big chain pharmacies closing thousands of stores, leaving behind a dwindling supply of overworked pharmacists who are just as frustrated as the patients.

This is probably not a good time to embed pharmacists in clinical practices, and make a bad situation even worse.

Meloxicam Almost Killed My Mom, Now FDA Has Approved an IV Version

By Crystal Lindell

Buried in the fine print for the newest non-opioid pain medication to be approved by the FDA is a stark warning that hits close to home. 

The FDA just approved Xifyrm, which is the branded IV version of the non-steroidal anti-inflammatory drug meloxicam for adults with moderate-to-severe pain.

It offers once daily dosing, and of course, manufacturer Azurity Pharmaceuticals highlights the fact that "Xifyrm provides a non-opioid analgesic" in its press release about the drug. 

There’s just one problem: it’s the same drug that almost killed my mom in 2022. 

If you look at the fine print in the prescribing information, you’ll see the disclaimer that points to one of the major risks that come with this medication. 

"NSAIDs, including meloxicam, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal,” Azurity warns.

They go on to say that these serious adverse events “can occur at any time, with or without warning symptoms.”

And 4 out 5 patients who develop these complications have no warning signs at all. 

Azurity then shares how common these complications are, writing that they occur in “1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year.”

They also add that “even short-term NSAID therapy is not without risk.”

Unfortunately, my mom was in the group of 2-4% of patients who were treated with mexlicam for one year and then had serious complications. 

Her doctor gave her the oral version for chronic hip pain because he didn’t want to give her opioids. She took it exactly as prescribed, and about one year later, meloxicam almost killed her. 

She had a very sudden and very serious perforated ulcer. 

My mom had no warning symptoms, just as the fine print for Xifyrm warns can happen. She collapsed at work and then was taken to the emergency room via ambulance. There, her sudden intense stomach pain was dismissed by staff for 9 hours before she finally got a CT scan. She was then immediately rushed into emergency surgery for a perforated ulcer. 

My mom spent the next week in critical care, unable to eat or drink anything at all for a full week while her stomach healed. 

It was a harrowing experience made worse by the fact that all of this happened during the height of the COVID lockdown, meaning none of us were able to visit her at all while she was in the hospital. 

And the thing is, she is one of the lucky ones, because she survived. 

We often hear harrowing tales of opioids causing overdose deaths, but that doesn’t mean that alternatives like NSAIDs are safe. The fact that 2-4% of patients could have a potentially fatal complication from this drug should scare both doctors and patients. 

Many doctors hesitate to prescribe opioid pain medications these days, even for post-surgical and cancer pain, and my fear is that this new IV version of meloxicam will quickly become one of their favorite alternatives, just as the oral version already is. 

Interestingly, the FDA recently released a boxed warning for veterinarians on the use of meloxicam in cats before surgery, saying repeated off-label use can cause sudden kidney failure and even death. 

When it comes to humans, it’s also noteworthy that Azuirty also makes it clear that this new IV medication shouldn’t be used alone when rapid pain relief is needed. That allows for the potential use of opioids, but I’m skeptical that doctors will heed that advice. 

A lot of doctors have an “avoid opioids at all costs” approach to pain care these days, but many of them have not reckoned with what that can actually mean for patients. They also rarely go over the true risks of NSAIDs with their patients, despite the fact that lectures about the dangers of opioids are common in medical care. 

These days, my mom is in good health, and in fact we just celebrated her 64th birthday. It’s a milestone that’s now all the more precious after we almost lost her.

I would urge doctors to exercise extreme caution when turning to opioid alternatives like Xifyrm, and other NSAIDs. They are not without risk. And in fact, they can be more dangerous than opioids.