Eilish, Dunham, Jamil: How Ehlers-Danlos Celebrities Raise Awareness and Scrutiny

By Crystal Lindell

I have to confess that I never watched the HBO Show Girls. It’s not that it looks like a bad show. In fact, almost the opposite. It sounds like a good show. 

But as a young millennial flailing through life when Girls premiered in 2012, I worried that I’d see myself — including my flaws — reflected back at me. And I just have never been in a place, mentally, to process that kind of personal attack. So I didn’t watch Girls.

When the show’s top star and creator Lena Dunham later revealed that she had the same health condition as me — Ehlers-Danlos Syndrome (EDS) — it only worked to confirm my fears. 

A lot of people hate Lena Dunham, and a lot of people also hate the character she played on Girls.

What if, through watching the show, I discover that I am like her?

What if I start to believe that I’m worthy of the same level of hate? And in the process, I start to hate myself?

After I was diagnosed with EDS in 2018, Dunham was among the first celebrities I remember seeing reveal her own diagnosis publicly. 

In the fall of 2019, Dunham posted unflattering paparazzi pictures of herself to Instagram — including one of her in a blue granny nightgown, holding a cane in one hand and a cellphone in the other.

LENA DUNHAM

“I could choose to be embarrassed by these paparazzi pics — I mean, that’s probably the point of someone publishing them in the first place — but I’m really not,” Dunham wrote.

“I could lie and say it was an early Halloween look… But the truth is just: This is what life is like when I’m struggling most with chronic illness. An Ehler-Danlos syndrome flare means that I need support from more than just my friends... so thank you, sweet cane!”

A lot of the online EDS community did not take the news well. 

One Reddit user wrote at the time: “Lena Dunham is an extremely problematic and troubled individual. If there is ANY celebrity whose claims — not just regarding illness but regarding all facets of autobiography — should be looked at with a critical and cautious eye, it’s her. She’s not someone we should, as a community, try to turn into a role model or representative for EDS.”

The sentiment summed up what a lot of EDS patients were saying on the internet at the time.

Finally, a celebrity bringing awareness to EDS, and I couldn’t even be excited about it? Instead, I worried that the people who hated her would now hate me too.

JAMEELA JAMIL

The other big name to reveal her EDS diagnosis in 2019 was Jameela Jamil.

And, unfortunately, she’s another celebrity who a lot of people love to hate. 

Two celebrities were out there spreading awareness about the very condition that has caused me immense health problems my entire life, but I couldn’t even post about it online without worrying about haters.

Over the years, a number of other celebrities have also revealed that they have EDS or a related hypermobility disorder, including: Selma Blair, Halsey, Sia, Cherylee Houston, Yvee Oddly and others. 

‘Been in Pain Since I Was Nine’

Most recently, Billie Eilish discussed her hypermobility, a condition often seen as related to EDS, in a recent Vogue profile. At times, she feels like she was at war with her own body.

“I’ve basically been in pain since I was nine,” said Eilish. “Growing up, I’d always hear people be like, ‘Just wait until you’re older! You’re going to have so much pain!’ And I remember being so furious.” 

Bringing EDS into the mainstream and creating awareness should, in theory, help more suffering patients get the diagnosis they seek. Ideally, it would also help lead to more research into the condition, including treatments and maybe even a cure. 

In a perfect world, increased awareness would also lead to more compassion for those struggling with the often painful symptoms of EDS. 

Sadly, over the years, I’ve watched the opposite often happen instead. As EDS has become more well-known, a lot of people have started to see EDS as a trendy diagnosis, the type patients want because they saw that a celebrity has it. 

BILLIE EILISH

In fact, a few years after I was diagnosed at a university hospital, I had a different medical specialist at the same university walk into the exam room and greet me for the first time with, “So what makes you think you have EDS?” 

He asked me as though I had Googled “EDS” on the way to the appointment and then decided to add it to my intake form on a whim. 

In fact, that’s been one of the most jarring things about having EDS. The condition has very obvious visual markers, but people will still try to claim it’s fake. 

My elbow extends way past the normal range of motion. You can’t fake that. 

Every celebrity I’ve seen who’s revealed their own EDS diagnosis has seemed intent on making sure that it is not seen as the most defining thing about them. It’s a truly understandable goal. I don’t want EDS to define me either. 

Unfortunately, EDS has started to be defined by the celebrities who have it: “That Lena Dunham-Jameela Jamil thing.” For better — and sometimes worse — they end up representing our condition in the eyes of the general public. 

While most EDS celebrities don’t have a slew of hate-fans behind them, none of them are fully beloved by the public. And, of course, that’s because being fully beloved by the public is impossible for any human being. 

In fact, all of us are flawed. So in that sense, EDS celebrities are just like us! 

How to Inhibit Reactivation of the Epstein-Barr Virus

By Dr. Forest Tennant

The Epstein-Barr virus (EBV) is a parasite that normally lives a dormant, harmless life in nasal and throat membranes and in our white blood cells. We are all carriers of EBV.

EBV usually enters the body and first activates during infancy, often resulting in a case of the "sniffles." In teenagers or young adults, it may trigger infectious mononucleosis. After the initial infection, the virus becomes dormant.

Unfortunately, EBV has the ability to reactivate, duplicate, and travel in the blood inside lymphocytes (white blood cells) to harm tissues and cause pain. How does this happen?

Biologic stress, meaning a physical or psychological situation that cause the hormones cortisol and adrenaline to elevate for more than a few hours, may lower one's immune system. That gives EBV the opportunity to reactivate, produce auto-antibodies, infiltrate tissue, and silently produce a painful condition.

The usual stressors that cause reactivation are physical trauma or injury, an infection, or emotional distress. People with medical conditions such as a genetic connective tissue disease (Ehlers-Danlos syndrome), diabetes, or stroke may have an immune deficiency that also makes them more prone to EBV reactivation.

EBV reactivation is similar to herpes or shingles reactivation. Like EBV, herpes and shingles are usually dormant and harmless viral infections, but they may reactivate and cause blisters or a skin rash.  

Unfortunately, EBV reactivation can be totally asymptomatic and unknown to the individual, until chronic reactivations cause a painful condition. This could result in fibromyalgia, small fiber neuropathy, burning mouth, herniated disc, arachnoiditis or even a cancer such as Hodgkin's disease or lymphoma. 

How to Diagnose and Treat EBV Reactivation

Persons with chronic pain severe enough to require daily pain relief medication may have EBV reactivation as a cause of their condition and should take steps to inhibit it. We recommend antibody testing for EBV reactivation in any person who has severe chronic pain for over 90 days and needs to take pain relievers daily.

Two antibodies are formed during EBV reactivation: the Viral Capsid Antibody (VCA) and Epstein-Barr Nuclear Antibody (EBNA).

Major laboratories offer three quantitative tests for VCA, EBNA and early EBNA antibodies. Qualitative tests (positive or negative) are not specific enough to make a diagnosis of EBV reactivation.

When VCA and EBNA antibodies are elevated above normal levels, a diagnosis of past reactivation is made, and the individual can properly be called a "chronic reactivator." We recommend that levels of VCA and EBNA be two or more times above normal, plus a patient having pain in two or more anatomic sites, to warrant a diagnosis of EBV reactivation.

If the early EBNA antibody is elevated above normal, therapeutic trials of antivirals and corticosteroids should be considered to reverse reactivation.

If both VCA and EBNA are elevated but the early EBNA is negative, we recommend the use of these vitamins and supplements to inhibit EBV reactivation:

• Vitamins C and D

• Astragalus

• Zinc

• Resveratrol

• Curcumin

• Selenium

• Luteolin

• Andrographis

• Lysine

Our research has found that about 90% of patients with adhesive arachnoiditis (AA) have EBV reactivation.  The good news is that once it is determined that a person has reactivation and autoimmunity, there are simple treatment measures that can be implemented.   

In our experience, the treatment measures tend to provide about 20% to 50% more pain relief when used with standard pain therapies. Failure to take therapeutic measures to control EBV may allow increased disease deterioration and pain. 

More information about the Epstein-Barr Virus and its relationship to chronic pain conditions can be found in our new book: "The Epstein-Barr Virus: A New Factor in the Care of Chronic Pain."  

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. Readers interested in learning more about this research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can also subscribe to its bulletins here.   

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

Racial Myths About Pain Are Embedded in Artificial Intelligence

By Crystal Lindell

A new study published in JAMA found that artificial intelligence (AI) programs are encoded with racial and ethnic biases – just like humans – when it comes to evaluating a patient's pain. 

The authors said they wanted to look into the issue because it's already well-known that doctors underestimate and undertreat black patients’ pain compared to white patients. 

To study how that may impact AI, researchers had 222 medical students and residents evaluate two different patients, one black and one white, who were both experiencing pain. They also had them evaluate statements about how race may impact biology, some of which were myths and some of which were true. 

Then the researchers had two Large Language Models (LLMs) widely used in AI — Gemini Pro  and GPT-4 — do the same by feeding them patient information reports, and then having them evaluate statements about how race impacts biology. 

There wasn’t much difference between the humans and the AI models when it came to rating patients’ pain, regardless of race. Both the humans and the AI models rated the patients as having similar pain scores. 

However, both the humans and AI systems had some false beliefs about race and patient pain. Gemini Pro fared the worst, while GPT-4 and the humans came out relatively similar. 

Specifically, Gemini Pro had the highest rate of racial myths (24%). That was followed by the humans (12%) and GPT-4 (9%).

“Although LLMs rate pain similarly between races and ethnicities, they underestimate pain among Black individuals in the presence of false beliefs,” wrote lead author Brototo Deb, MD, a resident at Georgetown University–MedStar Washington Hospital Center.

“Given LLMs’ significant abilities in assisting with clinical reasoning, as well as a human tendency toward automation bias, these biases could propagate race and ethnicity–based medicine and the undertreatment of pain in Black patients.”

Deb and co-author Adam Rodman, MD, says their study corresponds with previous research showing that AI models have biases related to race and ethnicity. 

Given how AI is increasingly used in clinical practice, there’s concern that black patients’ pain will continue to be undertreated, making them less likely to get opioids and more likely to be drug tested. 

There’s a common belief that AI will eliminate racial bias because computers are seen as more logical than humans. However, AI is encoded with data provided by humans, which means as long as humans have bias, AI will too. 

The real problem is if doctors start to rely too much on AI for patient evaluations, there’s a potential for real harm. Especially if doctors use AI to justify their medical decisions under the false belief that they are unbiased. 

It’s still unclear how these new AI systems will impact healthcare, but everyone involved should be careful to avoid relying too heavily on them. At the end of the day, just like the humans who program them, AI models have their flaws. 

Poppy Seeds Draw More Scrutiny for Addiction Risk

By David Hilzenrath, Healthbeat

It sounds like a joke: poppy seeds infused with opioids.

Indeed, it was a plotline on the sitcom Seinfeld. But for some it has been a tragedy. People have died after drinking tea brewed from unwashed poppy seeds.

And after eating lemon poppy seed bread or an everything bagel, mothers reportedly have been separated from newborns because the women failed drug tests.

Poppy seeds come from the plant that produces opium and from which painkillers such as morphine and codeine are derived. During harvesting and processing, the seeds can become coated with the opium fluid.

Members of the House and Senate have proposed legislation “to prohibit the distribution and sale of contaminated poppy seeds in order to prevent harm, addiction, and further deaths from morphine-contaminated poppy seeds.” The bill was one of several on the agenda for a Sept. 10 House hearing.

The day before the hearing, The Marshall Project and Reveal reported on a woman who ate a salad with poppy seed dressing before giving birth, tested positive at the hospital for opiates, was reported to child welfare, and saw her baby taken into protective custody. Almost two weeks passed before she was allowed to bring her baby home, the story said.

“It’s not an urban legend: Eating poppy seeds can cause diners to test positive for codeine on a urinalysis,” the Defense Department warned military personnel in 2023.

The U.S. Anti-Doping Agency long ago issued a similar warning to athletes.

The Center for Science in the Public Interest, a watchdog group, petitioned the FDA in 2021 to limit the opiate content of poppy seeds. In May, after more than three years with no response, it sued the agency to force action.

“So far the FDA has been negligent in protecting consumers,” said Steve Hacala, whose son died after consuming poppy seed tea and who has joined forces with CSPI. The lawsuit was put on hold in July, after the FDA said it would respond to the group’s petition by the end of February 2025.

The FDA did not answer questions for this article. The agency generally does not comment on litigation, spokesperson Courtney Rhodes said.

A 2021 study co-authored by CSPI personnel found more than 100 reports to poison control centers between 2000 and 2018 resulting from intentional abuse or misuse of poppy seeds, said CSPI scientist Eva Greenthal, one of the study’s authors.

Only rarely would baked goods or other food items containing washed poppy seeds trigger positive drug tests, doctors who have studied the issue said.

It’s “exquisitely doubtful” that the “relatively trivial” amount of morphine in an everything bagel or the like would cause anyone harm, said Irving Haber, a doctor who has written about poppy seeds, specializes in pain medicine, and signed the CSPI petition to the FDA.

Unwashed Seeds More Potent

On the other hand, tea made from large quantities of unwashed poppy seeds could lead to addiction and overdose, doctors said. The risks are heightened if the person drinking the brew is also consuming other opioids, such as prescription pain relievers.

Benjamin Lai, a physician who chairs a program on opioids at the Mayo Clinic in Rochester, Minnesota, said he has been treating a patient who developed long-term opioid addiction from consuming poppy seed tea. The patient, a man in his 30s, found it at a health food store and was under the impression it would help him relax and recover from gym workouts. After a few months, he tried to stop and experienced withdrawal symptoms, Lai said.

Another patient, an older woman, developed withdrawal symptoms under similar circumstances but responded well to treatment, Lai said.

Some websites tout poppy seed tea as offering health benefits. And some sellers “may use specific language such as ‘raw,’ ‘unprocessed,’ or ‘unwashed’ to signal that their products contain higher concentrations of opiates than properly processed seeds,” the CSPI lawsuit said.

Steve Hacala’s son, Stephen Hacala, a music teacher, had been experiencing anxiety and insomnia, for which poppy seed tea is promoted as a natural remedy, the lawsuit said. In 2016, at age 24, he ordered a bag of poppy seeds online, rinsed them with water, and consumed the rinse. He died of morphine poisoning.

The only source of morphine found in Stephen’s home, where he died, was commercially available poppy seeds, a medical examiner at the Arkansas State Crime Lab said in a letter to the father. The medical examiner wrote that poppy seeds “very likely” caused Stephen’s death.

Steve Hacala estimated that the quantity of poppy seeds found in a 1-liter plastic water bottle in his son’s home could have delivered more than 10 times a lethal dose.

Steve Hacala and his wife, Betty, have funded CSPI’s efforts to call attention to the issue. (The publisher of KFF Health News, David Rousseau, is on the CSPI board.)

The lawsuit also cited mothers who, like those in the investigation by The Marshall Project and Reveal, ran afoul of rules meant to protect newborns. For example, though Jamie Silakowski had not used opioids while pregnant, she was initially prevented from leaving the hospital with her baby, the suit said.

Silakowski recalled that, before going to the hospital, she had eaten lemon poppy seed bread at Tim Hortons, a fast-food chain, CSPI said in its petition. “No one in the hospital believed Ms. Silakowski or appeared to be aware that the test results could occur from poppy seeds.”

People from child protective services made unannounced visits to her home, interviewed her other children, and questioned teachers at their school, she said in an interview.

While on maternity leave, she had to undergo drug testing, Silakowski said. “Peeing in front of someone like I’m a criminal — it was just mortifying.”

Even family members were questioning her, and there was nothing she could do to dispel doubts, she said. “Relationships were torn apart,” she said.

The parent company of Tim Hortons, Restaurant Brands International, which also owns Burger King and Popeyes, did not respond to questions from KFF Health News.

In July, The Washington Post reported that Trader Joe’s Everything but the Bagel seasoning was banned and being confiscated in South Korea because it contains poppy seeds. Trader Joe’s did not respond to inquiries for this article. The seasoning is listed for sale on the company’s website.

The U.S. Drug Enforcement Agency says unwashed poppy seeds can kill when used alone or in combination with other drugs. While poppy seeds are exempt from drug control under the Controlled Substances Act, opium contaminants on the seeds are not, the agency says. The Justice Department has brought criminal prosecutions over the sale of unwashed poppy seeds.

Meanwhile, the legislation to control poppy seed contamination has not gained much traction.

The Senate bill, introduced by Sen. Tom Cotton (R-Ark.), has two co-sponsors.

The House bill, introduced by Rep. Steve Womack (R-Ark.), has none. Though it was on the agenda, it didn’t come up at the recent hearing.

Healthbeat is a nonprofit newsroom covering public health published by Civic News Company and KFF Health News, a national newsroom that produces in-depth journalism about health issues.  

CDC Is Worried About Shortages of ADHD Stimulants. What About Rx Opioids?

By Pat Anson

The Centers for Disease Control and Prevention is worried that shortages of stimulant medication used to treat attention-deficit hyperactivity disorder (ADHD) may be forcing some patients to turn to street drugs or even suicide.

In a new report, the CDC estimates that 15.5 million U.S. adults have ADHD¸ a condition that causes inattention, impulsiveness and hyperactivity. About a third of those patients were prescribed a stimulant, but 71.5% of them had difficulty getting their prescription filled because of shortages.

“Shortages of stimulant medications in the United States have affected many persons with ADHD who rely on pharmacotherapy to appropriately treat their ADHD,” wrote lead author Brooke Staley, PhD, an epidemiologist at the CDC’s National Center on Birth Defects and Developmental Disabilities.

“Patients experiencing these difficulties might seek medication outside the regulated health care system, increasing their risk for overdose because of the prevalence of counterfeit pills in the illegal drug market, which might contain unexpected substances such as fentanyl.”

This is the second CDC report in recent months to warn about stimulant shortages. In a CDC Health Advisory released in June, the agency said ADHD patients who are unable to obtain Adderall and other stimulants are at risk of “social and emotional impairment, increased risk of drug or alcohol use disorder, unintentional injuries, such as motor vehicle crashes, and suicide.”

The CDC’s concern about ADHD patients is in marked contrast to its ongoing neglect of pain patients, who face similar shortages of opioid medication.

In a recent PNN survey, 90% of pain patients said they experienced delays or problems getting their opioid prescriptions filled at a pharmacy. Desperate for relief, some bought counterfeit medication or other illicit drugs; obtained opioids prescribed to another person; or used alcohol, cannabis and other substances to ease their pain. Nearly a third said they considered suicide because their pain was so severe.

In short, the very same risky behavior that concerns the CDC about ADHD patients.   

We asked the CDC if it was studying the impact of opioid shortages on pain patients and instead got a defense of the ADHD study.

“There has been limited information about (ADHD) diagnosis and treatment in adults and this analysis aimed to fill that information gap – providing the first national estimates on prevalence of adult ADHD in more than a decade. It is also the first national estimates to describe age at diagnosis and treatment, including telehealth and difficulty filling stimulant prescriptions,” a spokesperson said in an email.

It would not be unreasonable to say that the CDC shares some of the blame for chronic shortages of hydrocodone, oxycodone and other prescription opioids. The agency’s controversial 2016 opioid guideline paved the way for steep cuts in opioid prescribing, resulting in “serious harm” to patients who were rapidly tapered and left in uncontrolled pain. Some committed suicide.

The CDC guideline also greased the skids of opioid litigation by exaggerating the risk of opioid addiction and overdose. Faced with a tsunami of lawsuits, drug distributors and pharmacy chains agreed to ration the supply of opioids at individual pharmacies, and drug makers cut back on the production of opioids to avoid further liability. As recently as last month, Teva Pharmaceuticals stopped production of immediate-release fentanyl medicines, potent pain relievers that were relied on by dying cancer patients.

The CDC has been silent about opioid shortages – so have the FDA and DEA.

“We don't make the medicines and we can't tell someone that they must make medicines. There are some things that are out of our control,” FDA Commissioner Robert Califf, MD, said in a 2023 interview. 

Faced with complaints about shortages of ADHD medication, the DEA recently said it would raise the supply of stimulants that drug makers are allowed to produce in 2025, but would continue with its decade-long campaign to reduce the supply of opioids.

That discrepancy hasn’t been lost on pain sufferers.

“You’ve corrected course for ADHD drugs, now do the same for opioid pain analgesics,” one patient posted in a comment on the DEA’s plan. “Do not cut opioids production in 2025. The shortages across the country will be worse, with a corresponding increase in suffering and deaths among chronic pain patients.”

“These proposals will only further the pain and harm on a community of disabled individuals that did not ask to be disabled,” wrote Rebecca Meadows. “Would you want your mother, brother, sister, child or yourself to suffer unnecessarily due to unwarranted cutbacks in pain medications being made? The amount of people who suffer now is ridiculous but it’s only going to get worse if we continue on this path.”

A former CDC epidemiologist wrote a book about how the CDC’s “Disastrous War on Opioids” made the overdose crisis worse. Opioid overdoses have nearly doubled since the 2016 guideline was released.

“There are still significant restrictions on people in chronic pain for no apparent benefit. There continues to be very high rate of overdoses,” said author Charles LeBaron, MD. “I'm kind of a diehard public health guy. I want to see whether anything good happens. Nothing good happened. Time to reconsider.”

Peer Reviewers of Medical Studies Have Conflicts of Interest

By Crystal Lindell

How much are medical studies impacted by financial conflicts of interest? New research shows the problem may run deeper than most people realize. 

The authors of peer-reviewed studies in medical journals usually have to disclose whether or not they received money from pharmaceutical companies or medical device manufacturers. But new research published in JAMA looks at the next layer: the peer reviewers themselves.

Due to the “traditionally opaque nature of peer review,” it’s difficult to investigate the issue, but an international team of researchers studied peer reviewers at high-impact medical journals like The BMJ, JAMA, The Lancet, and The New England Journal of Medicine.

They looked specifically at nearly 2,000 U.S-based physicians who served as peer reviewers. 

What they found is both unsurprising and alarming. Between 2020 and 2022, more than half (58.9%) of the peer reviewers analyzed had received at least one industry payment. In total, the peer reviewers received a staggering $1.06 billion in industry payments. 

It should be noted that companies don’t spend that kind of money out of some noble love of medicine. No, they are doing it because it helps increase their profits or advances their interests. 

Most of that money – $1 billion or 94 percent – was paid directly to individuals or to their institutions to help fund research programs. That’s why academics who churn out studies are highly prized at universities and research institutes.

The rest of the money – $64.18 million – was in the form of general payments, which includes everything from speaker fees and “honoraria” to food, drink, lodging and travel expenses. 

The median general payment to a peer reviewer was $7,614, while the median research payment was $153,173. 

Interestingly, the average male reviewer had a significantly higher total payment ($38,959) than the average female reviewer ($19,586). 

The authors also broke down differences between medical specialties. Doctors who specialize in cardiology, rheumatology, oncology, immunology or addiction treatment were the most likely to get payments (73.5%), followed by surgeons (72%), psychiatrists (65%), hospital-based specialists (47%) and primary care physicians (38%).

Those results shed light on which fields of medicine may be more susceptible to conflicts of interests.

The study’s authors came to the only conclusion that makes sense given all this data: "Additional research and transparency regarding industry payments in the peer review process are needed."

I agree that this is clearly an issue that needs to be addressed. But we shouldn’t have to wait for more research to start taking action. We need stronger policies at medical journals to help contain the potential harm it’s causing. 

At the very least, peer reviewers should have to disclose conflicts of interest. While that may conflict with the policy of some journals to keep peer reviewers anonymous, given the potential for bias and other negative consequences, it seems the financial disclosures should take precedence. 

Since peer reviewers also have the ability to reject research before it’s even published, they should have their names and potential conflicts listed in the publications. 

Beyond that, medical journals need to start having difficult conversations about whether peer reviewers should even be allowed to review studies that involve companies or industries that pay them. 

While it may not be entirely possible in our for-profit healthcare system, that doesn’t mean it shouldn’t be explored. After all, the study did not find that 100% of peer reviewers accepted payments. So clearly some peer reviewers found a way to do the work without an obvious conflict of interest.

It isn’t just medical journals that do a poor job flagging the conflicts of peer reviewers. When PNN made a Freedom of Information Act (FOIA) request to the CDC seeking more information about the “Core Expert Group” involved in the agency’s 2016 opioid guideline, most of the documents we received back were heavily edited or redacted.

The CDC’s FOIA office said the group was exempt from our request because of “deliberative process privilege” and that disclosing their conflicts would have been “a clearly unwarranted invasion of personal privacy.”  

Why Conflicts Matter

Why do conflicts of interest matter? The easiest way to understand it is that whenever money is involved, it can potentially lead to what is essentially a boss-employee power dynamic. And typically, people don’t like to upset their bosses. 

Intuitively, most people also understand that if a medical device company funds medical device research, the researchers are incentivized to manipulate both the research methods and results in hopes of providing the funder the results they seek. 

Sometimes it’s deliberate, but sometimes it just happens on a subconscious level. People naturally favor people who give them money. However, in this case, the result of that favoritism could harm the health of millions of patients. 

In one high-profile example from 2018, a top cancer researcher failed to disclose the millions of dollars in payments he received from drug and healthcare companies.

As ProPublica and The New York Times reported, Dr. José Baselga, then-chief medical officer at Memorial Sloan Kettering Cancer Center in New York, had a number of undisclosed conflicts of interests. 

One such conflict may have led Baselga to put a positive spin on the results of two Roche-sponsored clinical trials — trials that many others had considered disappointments. He did this without disclosing the more than $3 million in consulting fees he’d received from Roche. He also left out that he had a stake in a company Roche had acquired. 

Baselga resigned just days after the news investigation came out, but journalists just don’t have the resources to constantly investigate every single researcher for conflicts of interest. That’s why medical journals must regulate the issue themselves. 

Yes, most medical journals already have policies requiring study authors to disclose conflicts of interest, but as this new research makes clear, that’s not enough. It’s past time for peer reviewers to be required to do the same. 

After all, it’s not just because the public deserves to know. Our lives could depend on it. 

Do You Hurry to Outrun the Pain?

By Carol Levy

I'm infused with impatience. I do everything fast.

I used to swim at the YMCA. I didn’t feel like I was moving quickly, but to others I was a speeding bullet knifing through the water. As soon as I stopped, to make my turn at the end of the lane, invariably someone watching would yell down at me, “What's your rush? Isn't it more fun if you enjoy it?”

Not for me. It's not just the physicality of moving swiftly through the water, which for me is a wonderful feeling. More important is getting to the end of the mile of swimming I try to complete, before something happens to trigger my pain.

I can't tolerate touch to the left side of my face, due to trigeminal neuralgia and phantom pain. Just the idea of a droplet of water touching my face terrorizes me, so I only do the backstroke.

One day a man asked me, “Is that the only stroke you know? I could teach you others.”

I didn't want to explain why I only did the backstroke, so I shrugged my shoulders and swam away. 

The backstroke works for me because my arms move in such a way that they don't fire off bullets of water that might hit my face. Regardless, I am always at the mercy of the thought, “Be careful! Finish this before you get hit in the face with a droplet.”

I'm impatient because I have to outrun the pain. I get to the Y early, impatient to get into the pool before others, so no one gets in the lanes next to me and splashes water on my face.

This is true of almost every aspect of my life. I shop fast because using my eyes too much triggers the pain. The faster I go through a store, the less opportunity I have to see things I want to see, but did not come to buy.

On rare occasions, I get sidetracked.  I forget.  I start to look at what else they have. My eyes start to travel up and down the shelves, and the pain grows to such heights that I fear my ability to get out of the store and drive home safely. So, I rush.

Before my trigeminal neuralgia, I loved to read. I could read a whole book in a few hours. And as soon as I finished, like the joke about eating Chinese food, I'd be hungry to start a new one.

Now I can read only a few pages at a time, skipping words, paragraphs, pages, looking for the dialogue that essentially explains the story. Who the main characters are and what their relationships are with each other, are lost to me.

I am impatient to get to the end. Not to see who the murderer is (I love mysteries the best), but to get to the end quickly, so the pain doesn't interfere.

I could go on and on with other examples, but they don't matter. At the end of the day, they all boil down to one thing: Hurry up! Hurry up! The pain is coming! The pain has started!

But I have to get to the end. The end of the swimming lane, the grocery list, and the end of the book.

There are changes we all go through, no matter our circumstances. But I think pain sufferers change more than most people -- and the changes are largely the result of trying to outrun the pain. It’s an impatience that’s very hard for those without pain to understand.

As for me? I used to be the tortoise. Now I'm the hare. Right now, I'm hurrying to finish writing this column before the pain takes over from using my eyes so much.

Pain makes me rabbit my way through life. The tortoise, ambling by, gets to look at the scenery. The hare in us makes it hard to stop and smell the roses.

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. 

New Mothers Lose Custody of Babies After False Positive Drug Tests

By Crystal Lindell

A California mother wasn’t allowed to take her newborn baby home because she ate a Costco salad with poppy seeds and then tested positive for codeine.

A woman in Philadelphia had her baby taken away by child welfare workers after her prescription ADHD medication resulted in a positive drug test for meth. 

A Pennsylvania woman had her newborn taken away by the state for three months because she tested positive for opioids after eating pasta salad.

These are just some of the stories shared in an alarming investigation by The Marshall Project about hospitals giving urine drug tests to new moms — and then reporting them to child welfare agencies when the tests show false positives. 

The Marshall Project interviewed dozens of patients, medical providers, toxicologists and other experts to report the story. They also collected information on over 50 mothers who faced investigations over positive drug tests that were likely wrong. 

At least 27 states require hospitals to alert child welfare agencies if a mother tests positive for an illicit drug, but no state requires hospitals to confirm the test results before reporting them.

While it's unclear how many of the nation’s 3.6 million births every year involve drug testing, healthcare experts told The Marshall Project that urine screening is ubiquitous and “tens of  thousands of infants are reported annually to authorities for in utero drug exposure, with no guarantee that the underlying tests are accurate.”

Many common foods and medications — from antacids and antidepressants to blood pressure and cold medicines — can prompt false results because urine drug tests are often inaccurate.

“People should be concerned,” Dr. Stephen Patrick, a neonatal researcher told The Marshall Project. “This could happen to any one of us.”

A 2001 article in the BMJ makes it clear that, unfortunately, this is not a new problem. The article focused on a U.S. Supreme Court ruling regarding hospitals drug testing new mothers. In a 6 to 3 decision, the court ruled that hospitals cannot drug test pregnant women without their informed consent or a valid warrant if the purpose is to alert the police to a potential crime.

“While the ultimate goal of the programme may well have been to get the women in question into substance abuse treatment and off drugs, the immediate objective of the searches was to generate evidence for law enforcement purposes in order to reach that goal,” the Court said. “It is especially difficult to argue that the program here was designed simply to save lives.”

Although that ruling came down two decades ago, The Marshall Project found that hospitals have gotten around it by using drug screenings to report patients to child welfare services, instead of the police. 

We should call these child welfare interventions what they are: kidnappings. And like any kidnapping, they can cause long-lasting harm to mothers, children and families. 

A 2022 report from Human Rights Watch and the American Civil Liberties Union focused on children who were unjustly removed from a parent's home, often because of the perception by child welfare workers that poverty leads to neglect. 

"Removing a child from their parents, even for a short time, can be highly traumatizing, with long-term consequences," the report found. "In some cases, children in out-of-home placements experience maltreatment, including sexual or physical abuse, causing further trauma."

The Marshall Project found that false-positive drug tests were impacting mothers of all socioeconomic classes and occupations — from a lawyer to a school librarian to a nurse.

There’s a special type of outrage that comes from knowing that hospitals are taking away newborns based on faulty drug tests. But I would argue that the outrage shouldn’t stop there. 

New mothers who actually misuse drugs should not automatically have their babies stolen by the government either. Someone who takes a stray Norco tablet left over from a relative’s past surgery isn’t automatically a bad parent just because they used a prescription drug that wasn’t their own.

The United States has done such a great job spreading “War on Drugs” propaganda that most people just blindly accept the assertion that drug use unequivocally creates an unsafe environment for a baby. Just looking at our evolving cannabis laws shows that past assertions about “Reefer Madness” were not based on any real evidence. 

‘We’re Going to Be Held Liable for That’

One doctor interviewed by The Marshall Project tried to justify the heinous policy of automatically involving child welfare departments after a mother’s positive drug test. He shared a sentiment that many pain patients have heard from doctors and pharmacists about opioid medication.

“God forbid the baby goes home, withdraws and dies, we’re going to be held liable for that,” Dr. Adi Davidov, an obstetrician at Staten Island University Hospital, which drug tests every birthing mother, told The Marshall Project.

"Liable." The word is so telling. As usual, the hypothetical potential for the doctor to face even minor repercussions is the real worry.  

If treating a newborn for opioid withdrawal was really the concern, that could easily be addressed without any involvement from child welfare departments. 

Of course, these policies are also examples of “do as I say, not as I do.” The Marshall Project found that while mothers often lack legal protection from false positives, “most of the caseworkers who investigate them are entitled to confirmation testing and a review if they test positive for drugs on the job."

Allowing for confirmation testing is the type of policy that’s created when the policymakers are concerned about protecting child welfare workers. When it comes to new mothers though, that empathy dies. 

My hope is that the report from The Marshall Project prompts governments and hospitals to re-evaluate their drug testing policies and stop automatically reporting mothers to child welfare agencies. But after watching the War on Drugs up close for over a decade, I’m not optimistic. 

The most effective tactic the War on Drugs uses is convincing people that its harmful policies won’t hurt them. That only bad people use drugs and good people don’t, so you’ll be safe. We’re only after the bad guys.

But the War on Drugs has never been about helping people. Many pain patients have already learned that lesson the hard way, as doctors refuse to give them the opioid medications they need to function. 

But the war is relentless. It never stops. And it’s always seeking new ways to extend its long, dangerous claws into people's lives in unexpected ways. 

As the saying goes, none of us are safe until all of us are safe. Until we drastically reframe our views and policies regarding drug use, we all remain potential victims of the War on Drugs. 

DEA Plans More Cuts in Opioid Supply, While Raising ADHD Stimulant Production

By Pat Anson

The U.S. Drug Enforcement Administration is planning more cuts in the supply of prescription opioids in 2025, while raising production of amphetamine and other stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

If the DEA’s plans are finalized after a public comment period, it would be the ninth consecutive year the opioid supply has been reduced.

Under the Controlled Substances Act, the DEA has broad legal authority to set annual aggregate production quotas (APQs) for drug makers – in effect telling them how much Schedule I and II chemicals and medications they can produce. DEA sets the quotas after consulting with the Food and Drug Administration (FDA) and other federal agencies, as well as individual states about the projected need for controlled substances.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2025 will decline on average 6.6 percent from calendar year 2024 levels. These declines are expected to occur across a variety of schedule II opioids. These declines are expected to occur across a variety of schedule II opioids,” the DEA said in a notice recently published in the Federal Register.

There will not be 6.6% cuts across the board for every opioid. Unlike previous years, the agency is proposing only slight reductions in the supply of fentanyl, oxycodone, hydrocodone and hydromorphone, while keeping quotas unchanged for morphine and codeine.

Most of the cuts are very minor – less than a tenth of one percent -- when the proposed APQ’s for 2025 are compared to the ones adopted in 2024.

DEA Opioid Production Quotas for 2025

• Fentanyl: 0.0025% decrease

• Oxycodone:  0.137% decrease

• Hydrocodone: 0.081% decrease

• Hydromorphone: 0.015% decrease

• Morphine: Unchanged

• Codeine: Unchanged

The DEA notice does not address the discrepancy between the FDA’s estimate of a 6.6% decline in medical need for opioids with the quotas it is proposing. The agency says it considered a “potential increase in demand for certain opioids” due to more elective surgeries being performed in 2025. Many of those surgeries were postponed during the COVID-19 pandemic.

The FDA predicted a 3.5% increase in domestic medical use of Schedule II stimulants in 2025. Demand for stimulants to treat ADHD has grown in recent years, but the drugs are also increasingly used to treat brain fog and fatigue caused by Long Covid. The FDA told DEA it was concerned about ongoing shortages of amphetamine, lisdexamfetamine, and methylphenidate, which are used to make stimulants such as Adderall.    

The DEA wants to raise production quotas for amphetamine (+5.9%) and lisdexamfetamine (+23.5%), while leaving the 2025 quota for methylphenidate the same as it was in 2024. The agency said inventories of amphetamine and methylphenidate-based products had increased, while shortages of lisdexamfetamin continue.

“DEA believes that manufacturers will be able to meet the increase in domestic medical need for these three schedule II stimulants with the APQs proposed in this notice,” the agency said.

The Myth of Opioid Diversion

The DEA has been cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by over 68% and hydrocodone by nearly 73% since 2015. Many of those cuts are due to pressure from Congress, as well as a common belief that prescription opioids are often diverted or sold to people they are not intended for.

That belief is largely a myth.

As required by Congress, DEA estimated the diversion rate of schedule II opioids in 2025, and once again came to the conclusion that diversion is rare – less than half of one percent for oxycodone and hydrocodone. Much of the diversion is a result of theft and losses in the supply chain, before opioids even reach patients.

Estimated 2025 Diversion Rates

• Oxycodone: 0.493%

• Hydrocodone: 0.379%

• Fentanyl:  0.013%

• Hydromorphone: 0.06%

The DEA’s diversion rates are partially based on “red flag” data from prescription drug monitoring programs (PDMP). Potential red flags include patients who see three or more prescribers in a 90-day period; patients who receive a daily opioid dose in excess of 240 morphine milligram equivalents (MME); and patients who pay in cash for a controlled substance.

DEA requested PDMP data from all 50 states, but only 29 states responded to the request by sharing summaries of their red flag data.

“While PDMP data is useful in estimating diversion, it is not conclusive. Further investigation would be required before concluding that any of the subject prescriptions were actually diverted. DEA continues to evaluate its methodologies in estimating diversion in an effort to set quotas more efficiently. State participation is crucial to accurate data analysis, and DEA anticipates working closely with states, as well as other federal and state entities, in future quota determinations,” the agency said.

Public Comments

The DEA quietly published its notice about 2025 production quotas in the Federal Register on September 25, with no fanfare or press release.

Usually the agency receives thousands of comments from the public about its production quotas, but so far there have been only a handful of comments posted. Many are from patients still bitter about the decade of cuts the DEA has imposed on the opioid supply, which have contributed to record shortages of prescription drugs.

“The actions that are being taken by Congress, by the DEA, state legislatures, and state medical boards, have caused THOUSANDS of these patients to lose access to their medications, have resulted in the improper prosecution of pain doctors, resulting in a severe nationwide shortage of pain specialists, and nationwide shortages of medications,” wrote David Smith.  

“The CDC, FDA, and DEA have severely underestimated the needs of chronic pain patients and misjudged the consequences of these cuts. While opioid misuse is a serious issue, penalizing legitimate pain patients is not the solution,” said Gina Harrison.

“Please I'm begging you not to cut opioids meds this year,” said Melissa Guthrie. “I'm on palliative care and there were a couple months last year I didn't get my meds due to shortages. You know it's not the pain meds causing harm. It’s the illicit fentanyl and street drugs killing people.”

You still have time to make your feelings known, as long as you do it by October 25, when the public comment period ends. To make a comment, click here.

How Western Diets Can Trigger Rheumatoid Arthritis

By Pat Anson

Researchers are learning more about how some foods and drinks affect our gut bacteria -- and potentially trigger an immune system response that leads to rheumatoid arthritis (RA) and other inflammatory chronic conditions.

The latest example is a review, published in the journal Nutrients, that examines how harmful bacteria can cause a phenomenon known as “gut dysbiosis,” an imbalance of intestinal microorganisms associated with the development of inflammation and autoimmune diseases like RA.

Previous studies have shown that RA patients don’t consume enough dietary fiber, which can cause gut dysbiosis. Fiber helps restore balance by acting as fuel for hungry – and beneficial -- gut bacteria.

“Overall, the current evidence suggests that gut dysbiosis is involved in the pathogenesis of RA,” wrote lead author Andrzej Pawlik, MD, a Professor in the Department of Physiology at Pomeranian Medical University in Poland. “The diversity and richness of the gut microbiome seems to be reduced in RA.

“Diet is an essential dietary factor, but it also acts as environmental trigger. Researchers have reported a dramatic increase in the frequency of autoimmune diseases in developed countries, and some of them suggest that the Western diet could contribute to this phenomenon.”

Western diets typically have more saturated fats and are often low in dietary fiber, which is why RA patients are often told to increase their fiber consumption. One study found that RA patients who ate high-fiber bars and cereals for 28 days showed significant improvement in their physical and mental quality of life. High fiber intake also reduces the risk of obesity, diabetes, hypertension and other cardiovascular diseases.

Vegetarian and Mediterranean diets also promote the growth of healthy bacteria, slowing the progression of RA, and reducing joint pain.

“Dietary factors and interventions have a marked impact in controlling the progression of RA. Lifestyle modifications involving dietary changes such as higher fibre intake and reduced consumption of red meat should be recommended for patients diagnosed with RA,” said Pawlik, who says further studies are needed to examine the influence of probiotics and other diets on the inflammatory process.

Prevotella copri is a gut bacterium that has long been associated with rheumatoid arthritis. There are many others -- and some we’re just learning about.

A 2022 study identified a harmful gut bacteria known as Subdoligranulum didolesgii in about 20% of people diagnosed with RA. The bacterium has not been detected in the intestines of healthy people.

About 1.3 million people in the U.S. and 1 in every 100 people worldwide have RA, a a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing swelling, inflammation and bone erosion.   

Cancer Patients Abandoned When Fentanyl Painkillers Discontinued

By Pat Anson

Patients suffering from severe cancer pain are scrambling to find alternatives after a drug maker discontinued production of potent fentanyl analgesics.

Cephalon, which is owned by Teva Pharmaceuticals, notified the FDA in August that it was stopping production of Transmucosal Immediate-Release Fentanyl Medicines, known as TIRF medications. The FDA then told patients and prescribers that all TIRF meds would be discontinued on September 30.  

“The moment I heard TIRF medicine was being discontinued, I was nearly brought to tears because I fear going back to the way things were before.  I have until the supply runs out and that's it,” said Anthony, a 46-year-old Georgia man who has severe headaches from an inoperable brain tumor. He asked that we not use his last name. 

Anthony has been taking TIRF meds since 2016. He also had a pain pump surgically implanted to deliver opioids around-the-clock, but still needed TIRF for occasional breakthrough pain.

“To transition back to traditional opiates will be a major step back treating my breakthrough pain,” Anthony explained. “Before TIRF medications, I struggled, and my quality of life followed suit.  I spent more time laying horizontal in my bed. It's been a long battle. I'm lucky to still be here.”

TIRF meds are effective because they are absorbed quickly through the mouth and provide pain relief within minutes. The two meds discontinued by Teva are Actiq, a fentanyl lozenge, and Fentora, a fentanyl buccal tablet that dissolves in the mouth.

“Because both of these meds and possibly other forms of TIRF medications bypass the gastrointestinal tract, they are overwhelmingly beneficial in my breakthrough pain,” says Anthony, who is regularly drug tested to make sure he isn’t abusing TIRF.

“I do not get high or feel euphoria.  If I abused these meds that might be an issue, but I take as prescribed.  Plus, if I took more than intended, I would run out of meds before my next refill leaving me without.  Not to mention, I don't want to stop breathing.”   

‘I Think They’re Good Drugs’

Because TIRF medication is made with fentanyl, a synthetic opioid 100 times more potent than morphine, it is poorly understood by the public and often demonized by anti-opioid activists.

Illicit fentanyl is involved in about 70% of fatal overdoses, but prescription fentanyl is rarely diverted and has long played an essential role in treating severe pain. Less than one-tenth of one percent of prescription fentanyl – 0.088% -- is diverted, according to DEA estimates.

“I think breakthrough pain is a horrible thing, and I think these patients really benefit from these breakthrough pain medications,” said Tom Jenkins, PhD, Chief Scientific Officer and Co-Founder of Elysium Therapeutics, which is developing a new class of opioids with less risk of abuse.

“These transmucosal fentanyl drugs are really complementary to the profile of the breakthrough pain and really help patients manage it quite effectively. I think they're good drugs. I don't think they're widely prescribed, so I think the diversion of them is not as significant of a problem.”

Despite that, an op/ed being published in U.S. newspapers refers to TIRF meds as “candy” and “lollipops” – implying they are widely abused and marketed to children, not cancer patients.

“The withdrawal of these potent, short-acting fentanyl products is good news, but they never should have been approved in the first place,” wrote Dr. Adriane Fugh-Berman and Judy Butler, who are affiliated with PharmedOut and Physicians for Responsible Opioid Prescribing (PROP).

“Classified as transmucosal immediate-release fentanyl or TIRF products, these delivery methods are highly potent and highly addictive. The faster an addictive substance enters the bloodstream, the more abuse potential it has. TIRFs acted almost as fast as opioids used intravenously, and addicted many people.”

Fugh-Berman and several other PROP members have collectively been paid several million dollars by plaintiff law firms to be consultants or expert witnesses in opioid litigation, a detail not mentioned in the op/ed or by the news organizations that published it.

Adverse Events

It’s true that TIRF medications have been abused, but many of those cases involved Subsys, an oral fentanyl spray that was illegally marketed by Insys Therapeutics. Insys filed for bankruptcy in 2019, and the company’s founder and several top executives were later convicted of racketeering and bribing doctors.

According to the FDA, adverse events involving TIRF peaked in 2018, with nearly 22,000 reported cases. Since then, they’ve fallen by about 80%.

The decline in adverse events coincided with a steep drop in the number of cancer patients enrolled in the FDA’s Risk Evaluation and Mitigation Strategy (REMS) Program, which facilitated the safer prescribing of TIRF. Over 4,700 patients were enrolled in the TIRF program in 2017. Today there are fewer than 150.

Anthony is one of them.

“The small number of people on the meds are a result of the FDA strengthening the REMS requirements, making it a huge headache for doctors to not only prescribe TIRF meds, but also to keep patients on them, making so much extra work for the doctors,” Anthony told PNN. “Too much red tape involved, so doctors avoid like the plague.”

Another factor is cost. A supply of Actiq or Fentora that might last a few days or weeks for a cancer patient in severe pain will cost thousands of dollars. The drugs are often not covered by insurance.

‘It’s Opioid Phobia’

Why did Teva stop making TIRF medication? The company has not made any public statements about the discontinuation of Actiq and Fentora, and did not reply to PNN requests for comment.

The most likely explanation is that Teva’s bottom line was suffering, due in part to the costs of opioid litigation. In 2008, its Cephalon subsidiary paid a $425 million fine for the off-label marketing of Actiq and two other drugs. Then in 2022, Teva agreed to pay $4.25 billion to settle thousands of opioid liability lawsuits.

Last year, as part of a strategic restructuring, Teva discontinued production of generic oxycodone to focus on more profitable branded drugs.

“It's opioid phobia. I think these companies were spooked by the lawsuits. Maybe some of them did misbehave a little bit and deserved it,” said Elysium’s Jenkins. “I feel for the patients that were using these things appropriately, were getting relief, that are no longer able to access the drug.

“I can only imagine corporate lawyers were just saying, ‘Hey, this isn't worth it. Let's get out of this.’ And also the REMS program. I mean, the FDA is deliberately making it difficult for physicians to prescribe this drug, right?”

Caught in the middle of opioid litigation and a profit-driven healthcare system are cancer patients like Anthony.

“I do not feel the few remaining patients should be made to suffer by discontinuing TIRF medications.  I'm guessing they are doing this because it's no longer as profitable as it once was,” he said. “Why can't small batches be done to maintain the quality of life of the remaining TIRF patients?”

The FDA has shown no interest in keeping the REMS program alive by finding a new TIRF manufacturer. New applications from patients and prescribers are no longer being accepted. And calls to the program’s hotline go unanswered.

“FDA did not request this discontinuation. It is important to note that FDA does not manufacture medicine and cannot require a pharmaceutical company to make a medicine, make more of a medicine, or change the distribution of a medicine,” the agency said in a brief online statement.

Unsecured Opioid Prescriptions and Pet Meds Cause Child Poisonings

By Crystal Lindell

A new study highlights the need for patients and pet owners to make sure their opioid medication is kept secure and away from children. 

The study, published in The Journal of Pediatrics, looked at how young children are often exposed to prescription opioids.  The authors analyzed 230 pediatric opioid poisoning cases that were reported to the New Jersey poison control center over a 5-year period. Most of the exposures were unintentional and involved children under the age of two.

Researchers found that the opioids consumed by children most often belonged to parents (40%), grandparents (17.4%), friends and other family members (7.8%) or were intended for pets (4.3%).

Five incidents involved opioid medication that had been mixed with a food or treat intended for a pet. But when the pet didn’t take it or spit it out, a child found it. 

Dr. Diane Calello, a pediatric emergency physician and one of the study's authors, said it's common for a pet owner to mix medication with food to make it more palatable to their pet.  

“Anybody who has ever tried to give medications to a dog or a cat that doesn’t want to take it knows you put it in peanut butter or cheese,” Calello told WHYY News. “If you give a pet that medication and they walk six, eight feet away and then they spit it out on the ground, there’s that little morsel that happens to contain medicine in it and children can obtain that and put that in their mouth as well.”

As for the medications belonging to grandparents, Calello and her colleagues noted that older patients may not get much counseling on the proper storage of prescription drugs because healthcare providers assume they have no children living with them. 

Most of the child poisonings involved pharmaceutical opioids (86%), occurred in the child’s home (91%), and resulted in the child being admitted to a healthcare facility (84%).

Nearly 9% of the cases involved medication wrappers that were already opened, divided pills and buccal films that were improperly stored, and exposure to opioid residue left on tissue paper, cotton balls, cellophane and analgesic patches.

In some cases children came across used fentanyl patches, illicit drug paraphernalia, liquid opioids or discarded medication left in trash cans and handbags, or left on countertops. 

“People think when they’re handling intact medication in a prescription package, ‘That is something I need to keep safe,’” Calello said. “But you don’t have that same checkpoint in our brain for things that we throw away.”

The researchers recommend that the overdose reversing drug naloxone be prescribed to everyone getting opioids, whether they’re intended for a human or pet. Naloxone can be safely given to children after exposure.

Requiring naloxone prescriptions for patients getting opioids is controversial among pain patients, especially if they have to pay for it themselves out of pocket. 

However, studies like this show why anyone who takes opioids should consider carrying naloxone with them, especially if they are visiting a home with children.

Teen in Chronic Pain Had Surgery, but Insurer Won’t Cover It

By Lauren Sausser, KFF Health News

When Preston Nafz was 12, he asked his dad for permission to play lacrosse.

“First practice, he came back, he said, ‘Dad, I love it,’” recalled his father, Lothar Nafz, of Hoover, Alabama. “He lives for lacrosse.”

But years of youth sports took a toll on Preston’s body. By the time the teenager limped off the field during a lacrosse tournament last year, the pain in his left hip had become so intense that he had trouble with simple activities, such as getting out of a car or turning over in bed.

Months of physical therapy and anti-inflammatory drugs didn’t help. Not only did he have to give up sports, but “I could barely do anything,” said Preston, now 17.

No Medical Billing Code

A doctor recommended Preston undergo a procedure called a sports hernia repair to mend damaged tissue in his pelvis, believed to be causing his pain.

PRESTON NAFZ

The sports medicine clinic treating Preston told Lothar that the procedure had no medical billing code — an identifier that providers use to charge insurers and other payers. It likely would be a struggle to persuade their insurer to cover it, Lothar was told, which is why he needed to pay upfront.

With his son suffering, Lothar said, the surgery “needed to be done.” He paid more than $7,000 to the clinic and the surgery center with a personal credit card and a medical credit card with a zero-interest rate.

Preston underwent surgery in November, and his father filed a claim with their insurer, hoping for a full reimbursement. It didn’t come.

But the final bill did: $7,105, which broke down to $480 for anesthesia, a $625 facility fee, and $6,000 for the surgery.

‘Trying to Wiggle Out’

Before the surgery, Lothar said, he called Blue Cross and Blue Shield of Alabama and was encouraged to learn that his policy typically covers most medical, non-cosmetic procedures.

But during follow-up phone calls, he said, insurance representatives were “deflecting, trying to wiggle out.” He said he called several times, getting a denial just before the surgery.

Lothar said he trusted his son’s doctor, who showed him research indicating the surgery works. The clinic, Andrews Sports Medicine and Orthopaedic Center, has a good reputation in Alabama, he said.

Other medical providers not involved in the case called the surgery a legitimate treatment.

A sports hernia — also known as an “athletic pubalgia” — is a catchall phrase to describe pain that athletes may experience in the lower groin or upper thigh area, said David Geier, an orthopedic surgeon and sports medicine specialist in Mount Pleasant, South Carolina.

“There’s a number of underlying things that can cause it,” Geier said. Because of that, there isn’t “one accepted surgery for that problem. That’s why I suspect there’s not a uniform CPT.”

CPT stands for “Current Procedural Terminology” and refers to the numerical or alphanumeric codes for procedures and services performed in a clinical or outpatient setting. There’s a CPT code for a rapid strep test, for example, and different codes for various X-rays.

The lack of a CPT code can cause reimbursement headaches, since insurers determine how much to pay based on the CPT codes providers use on claims forms.

More than 10,000 CPT codes exist. Several hundred are added each year by a special committee of the American Medical Association, explained Leonta Williams, director of education at AAPC, previously known as the American Academy of Professional Coders.

Codes are more likely to be proposed if the procedure in question is highly utilized, she said.

Not many orthopedic surgeons in the U.S. perform sports hernia repairs, Geier said. He said some insurers consider the surgery experimental.

Preston said his pain improved since his surgery, though recovery was much longer and more painful than he expected.

By the end of April, Lothar said, he’d finished paying off the surgery.

Partial Payment

A billing statement from the surgery center shows that the CPT code assigned to Preston’s sports hernia repair was “27299,” which stands for “a pelvis or hip joint procedure that does not have a specific code.”

After submitting more documentation to appeal the insurance denial, Lothar received a check from the insurer for $620.26. Blue Cross and Blue Shield didn’t say how it came up with that number or which costs it was reimbursing.

Lothar said he has continued to receive confusing messages from the insurer about his claim.

Both the insurer and the sports medicine clinic declined to comment.

The Takeaway

Before you undergo a medical procedure, try to check whether your insurer will cover the cost and confirm it has a billing code.

Williams of the AAPC suggests asking your insurer: “Do you reimburse this code? What types of services fall under this code? What is the likelihood of this being reimbursed?”

Persuading an insurer to pay for care that doesn’t have its own billing code is difficult but not impossible, Williams said. Your doctor can bill insurance using an “unlisted code” along with documentation explaining what procedure was performed.

“Anytime you’re dealing with an unlisted code, there’s additional work needed to explain what service was rendered and why it was needed,” she said.

Some patients undergoing procedures without CPT codes may be asked to pay upfront. You can also offer a partial upfront payment, which may motivate your provider to team up to get insurance to pay.

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

Guideline: Pediatricians Can Prescribe Opioids to Children as Needed

By Pat Anson

Fears about children becoming addicted and overdosing on opioid medication have led to the undertreatment of acute pain in pediatric patients, according to a new clinical guideline by the American Academy of Pediatrics (AAP).

The AAP guideline – the organization’s first to address opioid prescribing to children and adolescents -- urges pediatricians to start with non-opioid medication when treating mild to moderate acute pain. Opioids can be prescribed if a child is in severe pain or doesn’t respond to non-opioid treatment.

“There’s been a big pendulum swing in the practice of medicine over the last two decades—first with opioid-overprescribing, then with a huge cutback in opioid prescribing, likely leaving some children’s pain undertreated,” said lead author Scott Hadland, MD, Chief of Adolescent Medicine at Massachusetts General Hospital and an Associate Professor of Pediatrics at Harvard Medical School

“We want pediatricians to prescribe opioids when they’re needed because untreated pain can lead to distress and psychological harm. At the same time, physicians need to take steps that reduce the long-term risk for addiction.”

The guideline recommends that immediate release opioids be used, starting with a low dose and an initial supply of five days or less. Opioids can be prescribed for longer periods if a child is recovering from trauma or surgery and the pain is expected to last longer than 5 days. Every prescription for opioids should also include a prescription for naloxone, an overdose reversal drug.

The AAP warns that codeine or tramadol should not be prescribed to patients younger than 12 years; adolescents 12 to 18 years of age who have obesity, sleep apnea, or severe lung disease; or when treating surgical pain after a tonsillectomy or adenoidectomy.

“For a patient with mild to moderate pain, doctors should always start nonopioid medications and treatment,” said guideline co-author Rita Agarwal, MD, a Pediatric Anesthesiologist and Professor at Stanford Medicine. “Opioids do remain an important tool for acute pain relief.  But there are times when acetaminophen and ibuprofen may be equally effective with fewer side effects, such as in procedures such as tonsillectomy, wisdom teeth removal, and fractures.”

The AAP’s guideline is based on a review of 11 clinical studies involving pediatric outpatients being treated for acute pain. Hundreds of other studies were excluded from the analysis because they involved adults or hospitalized patients.

The use of opioids by children and adolescents has been a contentious issue for many years. Opioids were once commonly prescribed after wisdom teeth removal, a practice that is now discouraged.

The AAP’s guideline review committee found that most children prescribed opioids do not become addicted or have an overdose. The risk of a child developing opioid use disorder or experiencing an overdose one year after a prescription ranged from 0.3% to 5.8%.

The World Health Organization (WHO) released a guideline in 2021 recommending that opioids only be given to children who are dying or seriously ill and not expected to recover. The WHO guideline found that “evidence of the effectiveness and safety of opioids is completely lacking in children.”  

Sickle Cell Patients Have Even Fewer Choices for Pain Relief

By Crystal Lindell

Pfizer is voluntarily taking its sickle cell disease medication Oxbryta (voxelotor) off the market, amid concerns that it could be causing deaths and other complications. Doctors are being told to stop prescribing Oxybryta and to start sickle cell patients on other medications. 

Pfizer said its decision was based on clinical data showing the overall benefits of Oxbryta no longer outweighs the risks. In postmarketing studies, patients taking Oxbryta had higher rates of a vaso-occlusive crisis, a condition that causes severe pain when mis-shaped red blood cells block the flow of blood to tissues and organs. Patients taking the medication also had higher death rates. 

The company said it was also discontinuing all clinical trials of Oxbryta and expanded access programs worldwide. Oxbryta has been on the market since 2019. The medication works by preventing red blood cells from becoming C-shaped and breaking down too quickly.

Pfizer’s announcement delivers another setback to sickle cell patients, who already lack treatment options and face discrimination in the healthcare system. There aren’t many treatments for sickle cell disease (SCD), a lifelong inherited blood disorder that can cause complications starting in early childhood and lead to shortened life expectancy.

The lack of treatments is due in part to the fact that SCD is relatively rare in wealthier countries. It primarily impacts those whose ancestors are from sub-Saharan Africa, an under-served patient population. About 100,000 Americans have SCD, a number so low it discourages drug makers from developing medications to treat it. Over 8 million people worldwide have SCD.

Many sickle cell patients have also borne the brunt of opioid phobia in the United States. They often end up having to go to the ER during pain flares, where many are treated as drug seekers. 

‘This Is a Step Backward’

The National Alliance of Sickle Cell Centers released a statement saying the Pfizer recall was disappointing. But they were glad that Pfizer was re-evaluating Oxbryta to see which SCD patients may still benefit from it..

"At this time, the risks are too great but there may be an opportunity in the future to better understand how to optimize this medication (and all) medications in sickle cell disease,” the organization said. 

It urged sickle cell patients currently taking Oxbryta to make an appointment with their doctor and emphasized that patients should not stop taking the drug abruptly. Instead, they should work out a weaning plan with their care team. 

“Don’t lose faith,” they said. “This is a step backward but we will stay on the path to better outcomes for everyone.”

The organization added that these types of issues highlight the importance of long-term follow-up with a sickle cell center and of clinical registries like GRNDaD, an international registry developed to track the effectiveness of SCD treatments.

“We encourage everyone to see a sickle cell specialist annually to review what is and what is not working for them,” the organization said. “We all know that sickle cell disease is highly variable, many people are different and respond differently to medications. We need to better understand these differences to identify which medication will work best for which people."

An article in MedScape explained that Pfizer’s decision to recall Oxbryta (voxelotor) came amid increased scrutiny of the drug by the European Medicines Agency (EMA). 

EMA began a review of voxelotor in July after data from a clinical trial showed that a higher number of deaths occurred with the drug than with placebo. Another trial showed a higher  number of deaths than expected. 

Pfizer’s Aida Habtezion, Pfizer’s Chief Medical Officer, said the recall was in the best interest of patients. 

“Our primary concern is for patients who suffer from SCD, which remains a very serious and difficult-to-treat disease with limited treatment options,” Habtezion said. “We advise patients to contact their physicians to discuss alternative treatment while we continue to investigate the findings from our review of the data.”

Patients, physicians, pharmacists, or other healthcare professionals with questions about Oxbryta should contact Pfizer at 1-800-438-1985.