Why Cheap Generic Drugs Are Harder to Find

By Dr. Geoffrey Joyce, University of Southern California

Past public ire over high drug prices has recently taken a back seat to a more insidious problem – no drugs at any price.

Patients and their providers increasingly face limited or nonexistent supplies of drugs, many of which treat essential conditions such as cancer, heart disease and bacterial infections. The American Society of Health System Pharmacists now lists over 300 active shortages, primarily of decades-old generic drugs no longer protected by patents.

While this is not a new problem, the number of drugs in short supply has increased in recent years, and the average shortage is lasting longer, with more than 15 critical drug products in short supply for over a decade. Current shortages include widely known drugs such as the antibiotic amoxicillin; the heart medicine digoxin; the anesthetic lidocaine; and the medicine albuterol, which is critical for treating asthma and other diseases affecting the lungs and airways.

What’s going on?

I’m a health economist who has studied the pharmaceutical industry for the past 15 years. I believe the drug shortage problem illustrates a major shortcoming of capitalism. While costly brand-name drugs often yield high profits to manufacturers, there’s relatively little money to be made in supplying the market with low-cost generics, no matter how vital they may be to patients’ health.

The shortage includes chemotherapy drugs, antibiotics, medications to treat ADHD and other critical drugs. Some patients are able to get their drugs, while others are not, and in some cases patients are getting ‘rationed care.’

Brand Name Drugs More Profitable

The problem boils down to the nature of the pharmaceutical industry and how differently the markets for brand and generic drugs operate. Perhaps the clearest indication of this is the fact that prices of brand drugs in the U.S. are among the highest in the developed world, while generic drug prices are among the lowest.

When a drugmaker develops a new pill, cream or solution, the government grants the company an exclusive patent for up to 20 years, although most patents are filed before clinical testing, and thus the effective patent life is closer to eight to 12 years. Nonetheless, patents allow the drugmakers to cover the cost of research and development and earn a profit without the threat of competition from a rival making an identical product.

But once the patent expires, the drug becomes generic and any company is allowed to manufacture it. Since generic manufacturers are essentially producing the same product, profits are determined by their ability to manufacture the drug at the lowest marginal cost. This often results in low profit margins and can lead to cost-cutting measures that can compromise quality and threaten supply.

Outsourced Production Creates Supply Risks

One of the consequences of generics’ meager margins is that drug companies outsource production to lower-cost countries.

As of mid-2019, 72% of the manufacturing facilities making active ingredients for drugs sold in the U.S. were located overseas, with India and China alone making up nearly half of that.

While overseas manufacturers often enjoy significant cost advantages over U.S. facilities, such as easy access to raw materials and lower labor costs, outsourcing production at such a scale raises a slew of issues that can hurt the supply. Foreign factories are more difficult for the Food and Drug Administration to inspect, tend to have more production problems and are far more likely than domestic factories to be shut down once a problem is discovered.

In testimony to a House subcommittee, Janet Woodcock, the FDA’s principal deputy commissioner, acknowledged that the agency has little information on which Chinese facilities are producing raw ingredients, how much they are producing, or where the ingredients they are producing are being distributed worldwide.

The COVID-19 pandemic underscored the country’s reliance on foreign suppliers – and the risks this poses to U.S. consumers.

India is the world’s largest producer of generic drugs but imports 70% of its raw materials from China. About one-third of factories in China shut down during the pandemic. To ensure domestic supplies, the Indian government restricted the export of medications, disrupting the global supply chain.

This led to shortages of drugs to treat COVID-19, such as for respiratory failure and sedation, as well as for a wide range of other conditions, like drugs to treat chemotherapy, heart disease and bacterial infections.

Low Profits Hurt Quality

Manufacturing drugs to consistently high-quality standards requires constant testing and evaluation. A company that sells a new, expensive, branded drug has a strong profit motive to keep quality and production high. That’s often not the case for generic drug manufacturers, and this can result in shortages.

In 2008, an adulterated version of the blood-thinning drug Heparin was recalled worldwide after being linked to 350 adverse events and 150 deaths in the U.S. alone.

In 2013, the Department of Justice fined the U.S. subsidiary of Ranbaxy Laboratories, India’s largest generic drug manufacturer, US$500 million after it pleaded guilty to civil and criminal charges related to drug safety and falsifying safety data. In response, the FDA banned products made at four of the company’s manufacturing facilities in India from entering the U.S., including generic versions of gabapentin, which treats epilepsy and nerve pain, and the antibiotic ciprofloxacin.

And while there may be multiple companies selling the same generic drug in the U.S., there may be only a single manufacturer supplying the basic ingredients. Thus, any hiccup in production or shutdown due to quality issues can affect the entire market.

A recent analysis found that approximately 40% of generic drugs sold in the U.S. have just one manufacturer, and the share of markets supplied by just one or two manufacturers has increased over time.

Repatriating the Drug Supply

It is hard to quantify the impact of drug shortages on population health. However, a recent survey of U.S. hospitals, pharmacists and other health care providers found that drug shortages led to increased medication errors, delayed administration of lifesaving therapies, inferior outcomes and patient deaths.

What can be done? One option is to simply find ways to produce more generic drugs in the U.S.

California passed a law in 2020 to do just that by allowing the state to contract with domestic manufactures to produce its own generic prescription drugs. In March 2023, California selected a Utah company to begin producing low-cost insulin for California patients.

Whether this approach is feasible on a broader scale is uncertain, but, in my view, it’s a good first attempt to repatriate America’s drug supply.

Geoffrey Joyce, PhD, is director of Health Policy at the USC Schaeffer Center, an associate professor and chair of the Department of Pharmaceutical and Health Economics at the USC School of Pharmacy, and research associate at the National Bureau of Economic Research.

Prior to his position at USC, Dr. Joyce was a Senior Economist at the RAND Corporation and currently co-directs UCLA's post-doctoral program in Health Services Research.

This article originally appeared in The Conversation and is republished with permission.

Pain Clinic Chain to Pay $11M to Settle Fraud Claims

By Don Thompson, KFF Health News

The owner of one of California’s largest chains of pain management clinics has agreed to pay nearly $11.4 million to California, Oregon, and the federal government to settle allegations of Medicare and Medicaid fraud.

The U.S. Department of Justice and the states’ attorneys general say Francis Lagattuta, a physician, and his Lags Medical Centers performed — and billed for — medically unnecessary tests and procedures on thousands of patients over more than five years.

It was “a brazen scheme to defraud Medicare and Medicaid of millions of dollars by inflicting unnecessary and painful procedures on patients whom they were supposed to be relieving of pain,” Phillip Talbert, U.S. attorney for the Eastern District of California, said in a statement this month.

The federal Medicare program suspended reimbursements to Lags Medical in June 2020, and Medi-Cal, California’s Medicaid program, followed in May 2021. Lags Medical shut down the same day the state suspended reimbursements. The company, based in Lompoc, California, had more than 30 pain clinics, most of them in the Central Valley and the Central Coast.

A KFF Health News review last year found the abrupt closure left more than 20,000 California patients — mostly working-class people on government-funded insurance — struggling to obtain their medical records or continue receiving pain prescriptions, which often included opioids.

Lagattuta and Lags Medical did not admit liability under the settlement. Lagattuta denied the governments’ claims, saying in a statement he was “pleased” to announce the settlement of a “long-standing billing dispute.” As part of the agreement, Lagattuta will be barred for at least five years from receiving Medicare and Medicaid reimbursements.

“Since the Centers have been closed for a couple of years, it made sense for Dr. Lagattuta to settle the dispute and continue to move forward with his other business interests and practice,” Malcolm Segal, an attorney for Lagattuta and the centers, said in the statement.

According to state officials, the federal government will receive the bulk of the money, about $8.5 million. California will receive about $2.7 million, and an additional $130,000 will go to Oregon. The settlement amount is based in part on Lagattuta’s and Lags Medical’s “ability to pay.” It does not cover the governments’ full losses, which the U.S. attorney’s office in Sacramento said are not public record.

Blanket Orders for Unnecessary Tests

A nearly four-year investigation by federal officials and the California Department of Justice found that from March 2016 through August 2021, Lagattuta and his company submitted reimbursement claims for unneeded skin biopsies, spinal cord stimulation procedures, urine drug tests, and other tests and procedures.

Lagattuta began requiring all his clinics to perform various medical procedures on every patient, the officials said, no matter if they were needed or requested by patients’ medical providers. Patients who refused were told they would have their pain medication reduced and could suffer adverse medical consequences.

U.S. and California investigators piggybacked on a federal claim filed in late 2018 by a whistleblower, Steven Capeder, Lags Medical’s former operations and marketing director, who will receive more than $2 million of the settlement.

As part of the settlement, Lagattuta and his company acknowledged that in mid-2016 he began requiring his providers to do at least two to three skin biopsies on Medicare patients each day and told providers to quit if they wouldn’t comply. Such biopsies are used to measure small-fiber neuropathy, which causes burning pain with numbness and tingling in the feet and lower extremities.

According to the settlement, a monthly report in early 2018 set a goal of performing 250 biopsies a week. Lagattuta created a separate team that was required to order at least 150 biopsies weekly, often overruling providers. And the company’s chief executive officer in late 2019 texted Lagattuta to report a particularly high number of biopsies, illustrating the text with emojis of a money bag and a smiley face.

Authorities said Lagattuta violated regulations requiring that skin biopsy results be interpreted by a trained pathologist or neurologist. Instead, they say, Lagattuta had the biopsies read by a family member who had no formal medical training and by a former clinic executive’s spouse, who was trained as a respiratory therapist.

Lags Medical clinics performed more than 22,000 biopsies on Medi-Cal patients from 2016 through 2019.

The settlement also alleges Lagattuta encouraged unsuitable patients to undergo spinal cord stimulation. It describes the procedure as “an invasive surgery of last resort,” in which implants placed near the spinal cord apply low-voltage electrical pulses to nerve fibers.

Lagattuta paid a psychiatrist $3,000 each month to falsely certify that every Lags Medical candidate for the procedure had no psychological or substance use disorders that would negatively affect the outcome, according to the settlement. For instance, the settlement says the psychiatrist overruled a Lags Medical social worker to OK the procedure for a young woman who had bipolar disorder with hallucinations that included hearing a man’s voice ordering her out of bed.

He also issued blanket orders for every patient to have urine drug testing, a policy the company’s CEO said “should be a big money maker.”

KFF Health News found that from 2017 through 2019 nearly 60,000 of the most extensive urine drug tests were billed to Medicare and Medi-Cal under Lagattuta’s provider number. Medicare reimbursed Lagattuta $5.4 million for those tests.

The clinics “carefully examined, tested, and treated” more than 60,000 patients during the time covered by the settlement, “when others might have been content to prescribe medication to mask pain,” said Lagattuta’s statement. 

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

FDA and DEA Silent as Rx Opioid Shortages Worsen

By Pat Anson, PNN Editor

Shortages of opioid pain medication in the U.S. appear to be worsening, with no apparent action from the FDA or DEA to ease the suffering of patients left in uncontrolled pain or going into withdrawal.

Last week the American Society of Health-System Pharmacists (ASHP) added another widely used painkiller to its drug shortage list: oxycodone/acetaminophen tablets, which are more widely known under the brand names Percocet and Endocet. The medication is typically prescribed for moderate to severe pain.   

The ASHP reports that five drug makers are either running low or have exhausted their supply of oxycodone/acetaminophen in 2.5, 5, 7.5 and 10mg tablets.  Amneal, Major and Rhodes did not provide ASHP with a reason for the shortage, while Camber and KVK-Tech said they were “awaiting DEA quota approval for active ingredient.”

Amneal, Camber and KVK-Tech said the tablets were on back order with no estimated resupply date. Major and Rhodes said additional supplies were expected in mid-September or early August, respectively. Limited supplies and doses of oxycodone/acetaminophen tablets are still available from other drug manufacturers.

There are already shortages of two other widely used painkillers. The AHSP put immediate release oxycodone on its list of drug shortages in March and added hydrocodone/acetaminophen tablets to the list in May.  

But those shortages have yet to be acknowledged by the FDA. Asked why oxycodone and hydrocodone were missing from the FDA’s drug shortage list, a spokesperson referred PNN to an FDA website for “Frequently Asked Questions about Drug Shortages.”

One possible explanation, according to the website, is that the FDA “focuses on shortages that have the greatest impact on public health.” Shortages are also not reported if they are expected to be resolved quickly, if other substitutes are available, or if there are only local supply issues.

Manufacturers are required to report shortages and supply interruptions to the FDA, while providers, hospitals, pharmacies and consumers can report them by email to drugshortages@fda.hhs.gov.  

‘No One Seemed to Care’

At PNN, we hear from readers almost daily about opioid shortages.

“I am now past my usual fill date,” said Rick Martin, a retired pharmacist in Las Vegas who lives with chronic back pain. “My CVS pharmacist manager told me that she was told by their wholesaler that hydrocodone won't be available until the middle of August.” 

Martin said pharmacists at Walgreens, Smith’s and Sav-on have also told him they were out of oxycodone and hydrocodone tablets.  

“It's been spotty for 6 months but now seems entrenched. I got switched to tramadol. Not as effective, but I can just barely get by. I've heard that's what doctors are doing. Tramadol or Tylenol with codeine,” he told PNN.

Steve Keating, another Las Vegas resident, has been taking oxycodone for chronic neck pain after his vehicle was rear-ended by another driver. He had no problems getting his prescription refilled at either Walgreens or CVS, until last month. Now he is out of pain medication. 

“I began having withdrawal symptoms. No one seemed to care,” said Keating, who turns 73 this month. “The pharmacy recommendations were to obtain tramadol, which I've tried in the past and found ineffective.  I cannot take opiates with acetaminophen as it upsets my stomach.   

“It seems that there is a huge gap between prescribers, pharmacies and whatever governmental agencies are involved.  Do these governmental idiots not realize how important the medication we've been prescribed for months or years is to give us some degree of a better quality of life?” 

There are several reasons behind the opioid shortages. It started with misleading information that demonized prescription opioids and the false portrayal of patients and doctors as the primary cause of the “opioid epidemic.” That was followed by medical guidelines that discourage opioid prescribing and a tsunami of opioid litigation that cost drug makers, wholesalers and pharmacies tens of billions of dollars. 

Egged on by politicians, the Drug Enforcement Administration also aggressively cut production quotas for opioids and other controlled substances, reducing the supply of oxycodone by 65% and hydrocodone by 73% since 2013.  

DEA PRODUCTION QUOTAS FOR OXYCODONE (KILOGRAMS)

SOURCE: DEA

The DEA quotas are rigidly enforced, making it difficult for a drug maker to boost production of opioids when another manufacturer has shortages or discontinues production, like Teva Pharmaceutical recently announced.

It’s not just opioids in short supply. Drugs used to treat cancer and attention deficit disorder (ADHD) are also hard to get. These problems have been building in plain sight for years, yet the FDA’s commissioner says there is little his agency can do to correct them.

“We wish that we could fix all these things, but 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 May interview. 

That’s not exactly true. The DEA sets annual production quotas for drug makers only after consulting with the FDA. The 2023 DEA quotas for hydrocodone, oxycodone and several other opioids were cut — for the 7th year in a row — based on the advice of the FDA.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2023 will decline on average 5.3 percent from calendar year 2022 levels,” the DEA said in a notice published last year in the Federal Register.   

DEA administrator Anne Milgram, meanwhile, has not made any public comments about shortages of opioid medication. In a recent appearance on Meet the Press, she said illicit fentanyl was being used to make counterfeit versions of prescription opioids — the same legal drugs that are now in short supply due to DEA actions.

“They're pressing it into these fake pills made to look exactly like oxycodone or Percocet or or Adderall, when it's just fentanyl and filler. So tens of thousands of Americans are dying without having any idea that they're taking fentanyl,” Milgram said.

(Update: On August 1, Milgram and Califf released a joint letter saying the FDA and DEA were working “as quickly as possible” to resolve the drug shortages, but took no responsibility for causing them. The letter only addressed shortages of prescription stimulants used to treat ADHD, binge eating and narcolepsy. It makes no mention of opioid shortages.)

My Story: Riding the Merry-Go-Round of Pain Care

By Christopher Matthews, Guest Columnist

About two and a half years ago, I began to feel a tight painful knot on the side of my neck. Any movement would trigger an intense shock up the back of my skull to the top of my head. Ultrasound, MRI and X-ray scans all came back negative, so we tried anti-inflammatory medications, ice, deep tissue message, chiropractic, and some lifestyle changes.

Over the next few months, the pain began radiating to my cervical spine and intensified. No OTC pain medication was touching this pain.  It felt like a hot steak knife was lodged in my back. The constant, unbearable pain and symptoms of neuropathy seemed to indicate that some minor disc bulging in my spine may be more severe than we thought.

It took 4 months to get an appointment with a specialist in neurosurgery at a prominent hospital in Massachusetts. The surgeon looked at me for 5 minutes and ordered more tests. They found some abnormalities in my arms and legs, but the imaging didn’t warrant surgery. They recommended that I see a neurologist, which meant waiting another 5 months for an appointment.

During the interim, my primary care doctor wanted to be proactive. She was the only one taking me seriously. I did physical therapy 3 days a week and about a dozen courses of oral steroids. I was hopped up on cortisone for months. I also had a series of injections into my spine. None of it seemed to help.

I finally saw the neurologist, who ordered another MRI, which showed the bulging discs in my back were getting worse. But I was still not a candidate for surgery.

I’ve now been hospitalized 4 times due to loss of function, pain flares or passing out from pain in public places. The pain is that bad. Some days I can’t even get out bed because my knees won’t work. Some days I have close to no use of my arms, because my elbows are on fire. I’ve been getting more and more bacterial infections.          

My primary care doctor is the only one who believes my pain is real. She showed mercy and set up a pain management contract with me. We started with 5mg hydrocodone/acetaminophen 3 times a day. I had never touched an opiate before in my life. What a relief! I was so happy I could cry, just for a few hours of pain relief.  

I got a second opinion from another neurologist, who ordered more imaging and blood tests. The images came back as they have in the past, but the blood tests also showed there was severe inflammation – a possible sign of autoimmune disease. So off to rheumatology I go. 

After another 5-month wait for an appointment, the rheumatologist orders more blood tests and an in-depth panel for autoimmune disease. Eight of those tests come back elevated and 4 of them are so high they’re alarming. I think to myself, “This may be terrible news or it may be good news. Either way, I’m finally getting a diagnosis.” 

Not even close. I get all these test results sent to me in an app, with a message from the doctor saying everything “looks fine.” He suggests aspirin and ibuprofen, and that I get off the hydrocodone.  

I lost my temper at that point. How dare you insinuate I’m drug seeking! Like I didn’t try every other option first. All those needles driven into my spine, the steroids, and off-label antidepressants. The months of physical therapy, chiropractic and emotional therapy, all before finally resorting to actual pain medication. 

Some of these doctors and pharmacists with their discriminatory attitudes and actions are disgusting. If it was about the drugs, I’d drive 10 minutes into town and buy them at a fraction of the price I pay at the pharmacy.  

This whole ordeal between deductibles and loss of wages has easily cost me over $100,000. I could have done so much with that money. My wife would have her student debt paid off by now. Instead, it all goes into the for-profit healthcare system. We’re not patients, we’re profits.  

Being on opioid medication now for 2 years, I cannot function without them. Without my pain medication, I feel like someone with industrial grade tools is trying to physically remove my head from my neck. 

CVS is a nightmare and the other pharmacies aren’t any better. They give you that look when you walk in or call to check on a prescription: “Oh, it’s you again. We spoke last month. You’re too early. We know why you people do that.” 

Excuse me, but I’m allowed to pick up my medication the day before I am out, so that I have medication available when I wake up the next day. So that I don’t have call you at 9am when you get in and then have to wait until 3 in the afternoon to pick it up. 

For a while, CVS was taking GoodRx coupons, which cut my insurance price in half. Recently, they told me there’s a new state law that prescription coupons were no longer valid for opioids. I checked with the state and no such law exists. The pharmacist does have the right to turn coupons away, but they flat out lied to me and said it was someone else making them do it.   

The number of days I’ve gone into withdrawal with brutal pain I wouldn’t wish on my worst enemy. All because CVS can’t find the prior authorization or they don’t tell me they are out of stock until I’m at the window to pick it up. Or some other excuse they can drum up. Just so they don’t have to give this “junkie” his drugs. It’s sickening.   

Now, all of a sudden, I can’t get hydrocodone of any dosage at any pharmacy within 50 miles of me. And none of them know when it’ll be back in stock. I found one pharmacy that had a three-week supply of hydrocodone, but by the time I got it called in and got there they said they only had two weeks supply for me because another patient needed a week.  

I’m officially up shirts creek without a paddle and don’t know what to do. I’m in the most pain I’ve ever felt in my life. It is 24/7 and unrelenting. It’s destroying my life, my marriage, my chance at children, my business, and my finances. I get sent from one specialist to another, and at each stop on the merry-go-round they extract $5 to $10 thousand from me in out-of-pocket tests.   

I’m not sure how much longer I can take it.  

Christopher Matthews is a pseudonym for the author, who asked that his full name not be used. He is 35 years old and played 3 years of professional soccer after graduating from college.

Do you have a “My Story” to share? Pain News Network invites other readers to share their experiences about living with pain and treating it.

Send your stories to editor@painnewsnetwork.org.

Can Risk Scores Help Predict if Chronic Pain Will Spread?

By Pat Anson, PNN Editor

The term “biopsychosocial” is a bit of a dirty word in the pain community. Many patients feel that studying the biological, psychological and social factors involved in chronic pain trivializes their physical pain by linking it to anxiety, fatigue, trauma and other stressful life experiences – suggesting the pain is “all in your head.”

But researchers at McGill University in Montreal think biopsychosocial risk factors play a key role in determining the severity and spread of chronic pain to other parts of the body. And that could lead to better ways of treating and preventing pain.   

"By identifying common biopsychosocial factors associated with chronic pain, health care professionals could better personalize treatment plans and improve patient outcomes," said co-author Etienne Vachon-Presseau, PhD, Assistant Professor in the Faculty of Dental Medicine and Oral Health Sciences at McGill University.

Using data from the UK Biobank, a large biomedical database in the United Kingdom, McGill researchers analyzed nine years of health data for nearly 50,000 people who reported a common pain condition such as osteoarthritis, migraine, fibromyalgia and spinal disc degeneration. By the end of the study period, nearly half of the participants (44%) reported their pain had spread to more than one body site.

Why did some people develop chronic overlapping pain conditions (COPCs), while others did not?

To find out, the research team dug deeper into the data, using machine learning algorithms to study 99 different physical, psychological, demographic and sociological factors about the participants, such as their education, mental health, substance use, and socioeconomic status.

The study findings, published in Nature Medicine, identified the biggest risk factors associated with COPC: depression/anxiety, insomnia, neuroticism (feeling fed-up), fatigue, stressful life events, and a body mass index (BMI) above 30.

“Our findings suggest that the biopsychosocial model not only shapes pain experience and maintenance, but also predisposes the development of new pain sites, a phenomenon we refer to as the ‘spreading’ of pain sites,” researchers reported. “Furthermore, we found that the pain site co-occurrence was not random, with a strong dependence between proximal pain sites, shown from either acute or chronic pain sites and from correlations between pain intensity ratings. Thus, biopsychosocial risk scores developed for headache will also moderately predict knee pain and vice versa.”

Based on those findings, the McGill team developed a pain risk score that utilizes six simple questions:

Risk of Pain Spreading Screen

1. Do you have difficulty falling asleep at night or do you wake up in the middle of the night?

2. Do you often feel ‘fed-up’?

3. Over the past 2 weeks, how often have you felt tired or had little energy?

4. Have you ever seen a GP or psychiatrist for nerves, anxiety, tension or depression?

5. In the last two years, have you experienced a serious illness, assault, death of a spouse/partner or close relative, separation/divorce, or financial difficulties?

6. Is your BMI over 30?

McGill researchers say their questionnaire will help providers quickly assess the risk of a pain patient developing more severe pain and how the pain might spread across their body.

“Our model predicted chronic pain spreading across multiple body sites in nearly 50,000 out-of-sample individuals,” researchers said. “We showed that high sensitivity and specificity could still be obtained for certain chronic pain conditions using only six questions. The ability to predict chronic pain, particularly COPCs and its severe forms, with minimal effort has the potential to benefit both research and clinical practice.”

JAMA: Patients on Long-Term Opioids Often ‘Irrational’

By Pat Anson, PNN Editor

Do pain patients on long-term opioid therapy make irrational decisions? Is their mental capacity so diminished by opioids that they shouldn’t be involved in treatment decisions with their doctors?

The answer to both questions is often yes, according to a controversial new op/ed published in JAMA Internal Medicine. At issue is a recent update to the CDC’s opioid prescribing guideline, which calls for shared decision-making (SDM) when a prescriber considers tapering a patient or abruptly discontinuing their opioid treatment. The guideline was revised last year after reports of “serious harm” to patients caused by forced tapering.

“In situations where benefits and risks of continuing opioids are considered to be close, shared decision-making with patients is particularly important,” the 2022 guideline states.

But that advice about consulting with patients goes too far, according to the lead author of the JAMA op/ed, Mark Sullivan, MD, a professor of psychiatry at the University of Washington and a longtime board member of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

“The value of SDM has been recognized for many years but also has its limitations, including where patients make irrational or short-sighted decisions,” Sullivan wrote. “Long-term opioid therapy induces a state of opioid dependence that compromises patients’ decisional capacity, specifically altering their perception of the value and necessity of the therapy; and although patients with chronic pain are not usually at imminent risk of death, they often can see no possibility of a satisfying life without a significant and immediate reduction in their pain.”

Sullivan and his two co-authors, Jeffrey Linder, MD, and Jason Doctor, PhD, have long been critical of opioid prescribing practices in the U.S. In their conflict of interest statements, Sullivan and Doctor disclose that they have worked for law firms involved in opioid litigation, a lucrative sideline for several PROP members.

Sullivan, Linder and Doctor call for more “structured” decision-making that includes the patient’s family and friends, “motivational interviewing” of patients about opioid risks and treatment goals, and education about non-drug alternatives such as yoga and meditation.

“We believe that a fully individualized, unstructured decision-making process will not be adequate to protect patients receiving long-term opioid therapy,” they wrote.

“In the case of opioid prescribing, and especially opioid tapering, working to persuade the patient is almost always the best clinical strategy. But there are circumstances where tapering should occur even if the patient objects.”

— Dr. Mark Sullivan

And what happens if a patient refuses to have their dose reduced? The op/ed doesn’t explicitly state it, but in an email to PNN, Sullivan said forced tapering would be acceptable in some situations.

“In the case of opioid prescribing, and especially opioid tapering, working to persuade the patient is almost always the best clinical strategy. But there are circumstances (opioid use disorder, diversion, serious medical risks) where tapering should occur even if the patient objects,” Sullivan wrote.

Opioid diversion by patients is actually rare. The DEA estimates that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) will be used by someone they were not intended for.

As for patients on opioids behaving “irrational,” Sullivan and his co-authors cite an op/ed published 33 years ago in The New England Journal of Medicine (NEJM). But that article doesn’t even discuss opioids or tapering, it’s about whether patients and doctors should collaborate in making decisions about end-of-life medical care.  It also makes an important disclaimer that “even the irrational choices of a competent patient must be respected if the patient cannot be persuaded to change them."

Sullivan rejects that approach to opioid treatment.

“We cite (the NEJM article) to demonstrate that SDM does not exclude or prevent irrational decisions,” he wrote in his email.  “You are right that we do not endorse the conclusion you cite, that patient’s irrational decisions must be respected.”

In a rebuttal to Sullivan’s op/ed also published in JAMA Internal Medicine, Mitchell Katz, MD, and Deborah Grady, MD, dispute the notion that a patient’s choices shouldn’t be respected.

“Primary care professionals generally highly value the inclusion of the patient’s perspective in decision-making, consistent with the principles of patient autonomy and self-determination, and are loathe to go against a patient’s wishes,” they wrote.

“As primary care professionals, we have found it helpful to tell patients that it is not recommended to take more than a specific threshold of opioids and that we do not want to prescribe something that is not recommended. However, that does not mean sticking to rigid cut points for dose and duration of opioid use, abandoning patients, or having them undergo too rapid a taper.”

Others questioned JAMA’s decision to publish Sullivan’s op/ed.

“While I recognize the editors’ legitimate intellectual interest in providing a forum for open discussion on the opioid policy space, I question their decision to publish an editorial that represents an ongoing call for broad, ill-defined reductions in opioid prescribing,” said Chad Kollas, MD, a palliative care specialist who rejects the idea that patients shouldn’t be involved in their healthcare choices.

“Errantly embracing a lower evidentiary standard for medical decision-making capacity creates an unacceptable risk for harm to patients with pain by violating their rights of medical autonomy and self-determination.”

Opioids were once commonly prescribed in the U.S. for both acute and chronic pain, but those days are long over. Opioid prescribing has been cut in half, to levels not seen since the 1990’s. And many patients today have trouble just getting their prescriptions filled at pharmacies due to opioid shortages.

Despite that, fatal overdoses have climbed to record levels, with illicit fentanyl and other street drugs involved in the vast majority of drug deaths, not prescription opioids.

What Doctors Should Ask Patients in Pain

By Carol Levy, PNN Columnist

I learned in childhood to keep my mouth shut if I had pain or was feeling sick. My siblings would say, "Stop your whining. Just go to your room if you're feeling so bad, so we don't have to hear about it!"

I learned to say nothing, no matter how bad I felt.

That is how I still handle it today. When I see a doctor about my trigeminal neuralgia pain or some other pain, they’ll often say, “Your pain can't be as bad as you say. You don't act like you're in pain.”

I was at the neurosurgeon's office. One of his residents wanted to touch the left side of my face and I wasn't sure why. Maybe to see what I would do? He knew any touch to the affected area would set off horrible, terrible pain.

“Are you ready?” he asked before touching me. His finger hit the mark and I instinctively jumped back, but didn't make a sound. The resident looked at me; like he was waiting for a cry, scream, wail, or any normal vocalization of pain. Instead, I was silent.

“Are you okay?” he asked, somewhat warily. He didn't realize I was literally unable to answer. My childhood lesson not to speak about pain had morphed into mute silence as an adult. I was speechless; my larynx unable to produce a sound.

I cleared my throat a few times in an effort to speak, while raising a finger in the universal sign of “wait.” After a few minutes, I was finally able to speak, but my words would not come out clearly.  Once triggered, the pain takes its own sweet time before it settles down.

My words were interspersed with more throat-clearing: “I can't, hahahem, speak when the, hahahem, pain is triggered.” 

Others who have chronic pain usually say the opposite: “When a doctor sets off my pain or I am in pain, I have no choice. I scream, I cry or I curse. I make faces and grimace.”

It is an automatic response. And often the doctor's reply in words or facial expression is, ”I don't believe this act you're putting on."

So what's a pain patient to do? What's a doctor to do?

For us, it's simple. If the doctor says, “It really isn't necessary to be so loud and to use profanity, or to wail and scream. In fact, it makes me think you're being overly dramatic.”

We need to reply in a way that says, “Doctor, this is what I do to express my pain. It may be unusual to you, too loud, or too unpleasant. But it is the only way I know how to express it.”

The doctor on the other hand? He doesn't know unless he asks a key question: “How do you let others know if you are in pain or what your level of pain is? Do you express it by crying or with grimaces? Or do you become silent?”

It comes down to one of my favorite sayings: You don't know what you don't know. And if you don't know what you don't know, you don't know what to ask. Our doctors need to ask.

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.

A Little Extra Weight Is Okay for Older Adults

By Judith Graham, Kaiser Health News

Millions of people enter later life carrying an extra 10 to 15 pounds, weight they’ve gained after having children, developing joint problems, becoming less active, or making meals the center of their social lives.

Should they lose this modest extra weight to optimize their health? This question has come to the fore with a new category of diabetes and weight loss drugs giving people hope they can shed excess pounds.

For years, experts have debated what to advise older adults in this situation. On one hand, weight gain is associated with the accumulation of fat. And that can have serious adverse health consequences, contributing to heart disease, diabetes, arthritis, and a host of other medical conditions.

On the other hand, numerous studies suggest that carrying some extra weight can sometimes be protective in later life. For people who fall, fat can serve as padding, guarding against fractures. And for people who become seriously ill with conditions such as cancer or advanced kidney disease, that padding can be a source of energy, helping them tolerate demanding therapies.

Of course, it depends on how heavy someone is to begin with. People who are already obese (with a body mass index of 30 or over) and who put on extra pounds are at greater risk than those who weigh less. And rapid weight gain in later life is always a cause for concern.

Making sense of scientific evidence and expert opinion surrounding weight issues in older adults isn’t easy. Here’s what I learned from reviewing dozens of studies and talking with nearly two dozen obesity physicians and researchers.

Bodies Change with Age 

As we grow older, our body composition changes. We lose muscle mass — a process that starts in our 30s and accelerates in our 60s and beyond — and gain fat. This is true even when our weight remains constant.

Also, less fat accumulates under the skin while more is distributed within the middle of the body. This abdominal fat is associated with inflammation and insulin resistance and a higher risk of cardiovascular disease, diabetes and stroke, among other medical conditions.

“The distribution of fat plays a major role in determining how deleterious added weight in the form of fat is,” said Mitchell Lazar, director of the Institute for Diabetes, Obesity and Metabolism at the University of Pennsylvania’s Perelman School of Medicine. “It’s visceral [abdominal] fat [around the waist], rather than peripheral fat [in the hips and buttocks] that we’re really concerned about.”

Activity Diminishes

Also, with advancing age, people tend to become less active. When older adults maintain the same eating habits (energy intake) while cutting back on activity (energy expenditure), they’re going to gain weight.

According to the Centers for Disease Control and Prevention, 27% of 65- to 74-year-olds are physically inactive outside of work; that rises to 35% for people 75 or older.

For older adults, the health agency recommends at least 150 minutes a week of moderately intense activity, such as brisk walking, as well as muscle-strengthening activities such as lifting weights at least twice weekly. Only 27% to 44% of older adults meet these guidelines, according to various surveys.

Experts are more concerned about a lack of activity in older adults who are overweight or mildly obese (a body mass index in the low 30s) than about weight loss.

With minimal or no activity, muscle mass deteriorates and strength decreases, which “raises the risk of developing a disability or a functional impairment” that can interfere with independence, said John Batsis, an obesity researcher and associate professor of medicine at the University of North Carolina School of Medicine in Chapel Hill.

Weight loss contributes to inadequate muscle mass, insofar as muscle is lost along with fat. For every pound shed, 25% comes from muscle and 75% from fat, on average.

Since older adults have less muscle to begin with, “if they want to lose weight, they need to be willing at the same time to increase physical activity.” said Anne Newman, director of the Center for Aging and Population Health at the University of Pittsburgh School of Public Health.

Ideal BMI Higher for Older Adults

Epidemiologic research suggests that the ideal body mass index (BMI) might be higher for older adults than younger adults. BMI is a measure of a person’s weight, in kilograms or pounds, divided by the square of their height, in meters or feet.

One large, well-regarded study found that older adults at either end of the BMI spectrum — those with low BMIs (under 22) and those with high BMIs (over 33) — were at greater risk of dying earlier than those with BMIs in the middle range (22 to 32.9).

Older adults with the lowest risk of earlier deaths had BMIs of 27 to 27.9. According to World Health Organization standards, this falls in the “overweight” range (25 to 29.9) and above the “healthy weight” BMI range (18.5 to 24.9). Also, many older adults that the study found to be at highest mortality risk — those with BMIs under 22 — would be classified as having “healthy weight” by the WHO.

The study’s conclusion: “The WHO healthy weight range may not be suitable for older adults.” Instead, being overweight may be beneficial for older adults, while being notably thin can be problematic, contributing to the potential for frailty.

Indeed, an optimal BMI for older adults may be in the range of 24 to 29, Carl Lavie, a well-known obesity researcher, suggested in a separate study reviewing the evidence surrounding obesity in older adults.

Lavie is the medical director of cardiac rehabilitation and prevention at Ochsner Health, a large health care system based in New Orleans, and author of “The Obesity Paradox,” a book that explores weight issues in older adults. Lavie and other experts say maintaining fitness and muscle mass is more important than losing weight for many older adults.

“Is losing a few extra pounds going to dramatically improve their health? I don’t think the evidence shows that,” Lavie said.

Unintentional weight loss is associated with several serious illnesses and is a danger signal that should always be attended to. “See your doctor if you’re losing weight without trying to,” said Newman of the University of Pittsburgh. She’s the co-author of a new paper finding that “unanticipated weight loss even among adults with obesity is associated with increased mortality” risk.

Maintain Healthy Diet

Ensuring diet quality is essential. “Older adults are at risk for vitamin deficiencies and other nutritional deficits, and if you’re not consuming enough protein, that’s a problem,” said Batsis of the University of North Carolina.

“I tell all my older patients to take a multivitamin,” said Dinesh Edem, director of the Medical Weight Management program at the University of Arkansas for Medical Sciences.

Losing weight is more important for older adults who have a lot of fat around their middle (an apple shape) than it is for people who are heavier lower down (a pear shape). “For patients with a high waist circumference, we’re more aggressive in reducing calories or increasing exercise,” said Dennis Kerrigan, director of weight management at Henry Ford Health in Michigan.

Maintaining weight stability is a good goal for healthy older adults who are carrying extra weight but who don’t have moderate or severe obesity (BMIs of 35 or higher). By definition, “healthy” means people don’t have serious metabolic issues (overly high cholesterol, blood sugar, blood pressure, and triglycerides), obesity-related disabilities (problems with mobility are common), or serious obesity-related illnesses such as diabetes or heart disease.

“No great gains and no great losses — that’s what I recommend,” said Katie Dodd, a geriatric dietitian who writes a blog about nutrition.

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

Veterans Say Cannabis Reduces Drug Use and Improves Quality of Life

By Pat Anson, PNN Editor

The U.S. Department of Veterans Affairs (VA) and the Department of Defense (DoD) have long taken a dim view of medical cannabis. VA providers are not allowed to recommend or prescribe cannabis, and veterans who admit using cannabis will have it recorded in their VA medical records, which could potentially lead to drug testing or “adjustments” in their treatment plans.

Despite those barriers, cannabis use among U.S. military veterans is growing. In a 2019-2020 survey, nearly 12% of veterans reported using cannabis, with younger veterans (20.2%) and those with psychiatric conditions (24%) even more likely to be cannabis users.

A new study helps explain the popularity of cannabis among veterans. In an anonymous survey of 510 veterans who use medical cannabis, 91 percent said it improved their quality of life and nearly half said it helped them reduce their use of over-the-counter and prescription drugs, including opioids, anti-depressants, muscle relaxers and anti-inflammatory medication.

Veterans who were Black, female, served in combat, and those with chronic pain were most likely to report a desire to reduce their use of “unwanted” medications.

“Many of the respondents reported that medicinal cannabis treatment helped them to experience a greater quality of life, fewer psychological symptoms, fewer physical symptoms, and to use less alcohol, fewer medications, less tobacco, and fewer opioids,” researchers reported in the journal Clinical Therapeutics.

“These findings should inform clinicians who work with the veteran population, as cannabis may be an effective means of helping veterans, especially women and racially minoritized members of this population, to reduce unwanted medication use.”

Previous research has suggested that medical cannabis may play a “harm reduction role” by helping people reduce or even stop their use of opioid pain medication. But a recent study found otherwise. In an analysis of prescription data for over 150,000 chronic pain patients, researchers found that opioid prescribing declined only slightly in states after medical marijuana was legalized.

The VA is also holding the line against using cannabis as a treatment for post-traumatic stress disorder (PTSD).  While many veterans use cannabis to relieve symptoms of PTSD and several states consider PTSD an approved use of medical cannabis, the VA maintains that “cannabis can be harmful,” especially when used long-term, and is “not recommended for the treatment of PTSD.”

Tylenol on Trial: Does Acetaminophen Cause Autism and ADHD?

By Teresa Carr, Undark Magazine

More than 100 families of children with autism and attention deficit hyperactivity disorder are suing companies that market acetaminophen, the pain reliever in Tylenol and an array of other medications. Tylenol-maker Johnson & Johnson, as well as major retailers that use acetaminophen in their store-brand products, knew about research linking prenatal use of acetaminophen to neurodevelopmental disorders in children, the families claim, and should have included warnings on product labels.

The court filings reveal mothers wracked with guilt, convinced that by taking an over-the-counter pain reliever, they caused their child’s disability. In case after case, these women say that if they had thought acetaminophen could possibly harm their baby, they would have minimized their use of the drug — or not taken it at all.

It’s hardly an open-and-shut case. Most of what is known about acetaminophen and pregnancy comes from a type of study that sifts through data looking for correlations between prenatal exposures and developmental disorders. Scientists have been fighting amongst themselves over how much weight to give these studies, which were not designed to prove that a given factor — in this case, acetaminophen — caused ADHD or autism.

The debate reached a boiling point in 2021, when a group of international scientists declared that the current research, limited as it is, warrants stronger warnings about the use of acetaminophen during pregnancy. In a consensus statement published in Nature Reviews Endocrinology, the scientists called for “precautionary action” through focused research and increased awareness of the drug’s potential risks. Ninety-one scientists, clinicians, and public health professionals from around the world signed on.

That statement was the “galvanizing incident” for the lawsuits, said Ashley Keller, a founding partner at the legal firm Keller Postman LLC and one of the lawsuits’ lead attorneys.

‘An Outlier Opinion’

But there’s a hitch: The consensus statement does not, in fact, reflect the views of many experts or of any major medical organization. The same Nature journal published three rebuttals signed by numerous professional groups as well as individual researchers and clinicians. These critics wrote that the consensus statement used flawed data to exaggerate potential harms of acetaminophen and downplayed the drug’s essential role for treating fever and pain.

Johnson & Johnson has seized on those criticisms in its defense. The consensus statement “is an outlier opinion of a small group whose position has been rejected by their own medical organizations and every regulatory body to address the issue,” company spokesperson Melissa Witt told Undark in an email. Giving credence to theories not based in sound science, she said, could harm millions of pregnant women.

This debate over how to interpret the acetaminophen science lies at the heart of the lawsuits, and the answer has profound implications, both for individuals and for public health. Acetaminophen is one of the most common drugs in the world, and in the United States, up to 65 percent of all expectant mothers use it. The cases have been consolidated in the Southern District of New York. If the litigation proceeds to trial, attorneys expect tens to hundreds of thousands of families to join in.

It’s a shame that questions linger about the safety of a drug that’s been around for 70 years, said Christina Chambers, a professor of pediatrics at the University of California, San Diego and lead investigator for a series of studies on exposures during pregnancy for the Organization of Teratology Information Specialists, a professional society that provides advice on using medications during pregnancy and breastfeeding.

In an interview with Undark, Chambers expressed doubts about the consensus statement, saying that if acetaminophen has any effect on fetal development, that effect is likely to be modest. Still, she added, “What this accumulated data calls for is to do better study.”

Top Selling Pain Reliever

Acetaminophen was discovered in 1878, according to an FDA history of groundbreaking medications. But it wasn’t until the early 1950s that researchers demonstrated that the compound worked as well as the two popular pain relievers of the time — aspirin and acetanilide — with fewer side effects. In 1955, drugmaker McNeil gained FDA approval and launched Tylenol Elixir for Children, advertising it “for little hotheads.”

Four years later Johnson & Johnson acquired McNeil, and, in 1975, began aggressively marketing an “extra strength” 500-milligram version of the drug to adults. By the early 1980s, Tylenol was the top-selling pain reliever in the U.S.

Acetaminophen is now used in more than 600 over-the-counter and prescription medications, including combination products for sleep, cough, cold, and allergy.

Acetaminophen is one of the most common drugs in the world, and in the United States, up to 65 percent of all expectant mothers use it.

Today, new medications typically undergo toxicity testing in animals before researchers study their safety and effectiveness in humans, but like many older drugs, acetaminophen didn’t undergo as thorough of a process. “Back in ’55 we weren’t doing preclinical testing for reproductive safety,” said Chambers.

Scientists do know that, in most cases, acetaminophen is the safest way for pregnant women to relieve fever and pain. “Not treating a fever — especially a high fever — can have consequences,” continued Chambers.

Strong data from lab animal and human studies have associated a high fever at certain points in pregnancy with an increased risk of birth defects and other fetal abnormalities. And, while it’s an understudied area, she said, chronic pain is associated with depressive symptoms, insomnia, and other harms to the mother and could adversely affect her pregnancy.

Some common over-the-counter drugs treat both fever and pain, such as nonsteroidal anti-inflammatory drugs like aspirin, ibuprofen (Advil), and naproxen (Aleve), but the FDA warns against using any of these after 20 weeks of pregnancy because these drugs can damage the unborn babies’ kidneys.

Meanwhile, other painkillers have their own drawbacks. Babies exposed to opioids during the first trimester of pregnancy are at increased risk for birth defects of the brain, spine, and spinal cord. In addition, studies show that regular use of opioids during pregnancy increases the risk of poor fetal growth, preterm delivery, stillbirth, and neonatal opioid withdrawal syndrome.

Medicinal cannabis may address pain, and some women might think of it as a natural and, therefore, safe alternative. But there’s very little data available on short- and long-term outcomes for mothers and babies exposed to the potent products available today, said Chambers. Recent studies suggest that cannabis increases the risk of preterm birth and smaller babies, but it’s hard to tease out the effects from other factors. She described the drug’s legalization and increased societal acceptance as “a huge experiment happening now.”

“So, what are you left with?” she asked.

In 1975, Johnson & Johnson began aggressively marketing extra-strength Tylenol to adults. In this 1983 commercial, the product is touted as the most potent pain reliever that can be bought without a prescription:

Rising Rates of Autism and ADHD  

For pregnant people experiencing fever or pain, acetaminophen is widely viewed as the best option. But can it also harm the fetus?

To begin answering this question, researchers have analyzed preexisting datasets of health information, looking for associations between acetaminophen use during pregnancy and neurodevelopmental problems in children. Such research is referred to as observational, and while it can be useful, this approach can’t typically prove causality.

Autism rates have climbed steadily since the Diagnostic and Statistical Manual of Mental Disorders, or DSM, first established it as a distinct disorder in 1980. In 2000, 1 in 150 children were diagnosed with autism by the age of eight according to the Centers for Disease Control and Prevention; by 2020, the number had risen to 1 in 36.

ADHD rates increased as well, though not as sharply. In 2019, 6 million children between the ages of 3 and 17 (9.8 percent) had received a diagnosis of ADHD, compared to 4.4 million children in 2003, according to CDC data from a national survey of parents.

Many experts attribute the bulk of that increase to greater awareness and broadening definitions of the disorders. Factors such as improved survival for premature infants and a trend toward starting families later may also play a role, as both prematurity and older parents are associated with increased risk for neurodevelopmental disorders.

In the early 2010s researchers additionally became interested in whether acetaminophen, so commonly used by pregnant people, could affect fetal development.

In 2014, after a couple of observational studies suggested a possible link, the Food and Drug Administration began a formal process to track data on the issue. The findings from the agency’s initial review of the evidence, based on limited and contradictory data, were inconclusive according to a Drug Safety Communication published the following year.

Since then, researchers from several countries, including the U.S., have published a steady stream of observational research. In 2021, an international group of researchers came together to review the evidence and craft a consensus.

“We all sat down and said, it’s time to put all this together; we’ve done reviews, there’s more and more evidence,” said lead author Ann Bauer, an epidemiologist at the University of Massachusetts Lowell. “We all felt that it was time for women to have this information.”

Of the 29 observational studies involving 220,000 mother-child pairs, 26 linked prenatal use of acetaminophen to neurodevelopmental disorders including ADHD, autism, language delays, lower IQ, and cerebral palsy among others. Sixteen studies showed a more-pronounced effect with longer-term use of the drug.

Bauer pointed out that a handful of observational studies published after the consensus statement also suggest an association.

The group conceded that the observational data is imperfect. The positive association could stem from other factors, such as heredity or the condition that prompted the woman to take the drug. Still, the researchers concluded that the combined weight of the data was strong enough to warrant warning labels on acetaminophen and for health care professional to caution women against indiscriminate use of the drug. Society should act now, they wrote, “not wait unequivocal proof that a chemical is causing harm to our children.”

In science, it’s always possible to find something wrong with individual studies, said David Møbjerg Kristensen, a professor of molecular biology at Roskilde University in Denmark, one of the consensus authors. “But it’s more when you have all the studies lining up that you begin to be concerned,” he said.

‘Irresponsibly Published’

But other experts say that it’s misleading to stack up profoundly limited data and conclude that, as a whole, it carries more weight.

The paper from Bauer’s team was “irresponsibly published,” said Nathaniel DeNicola, an obstetrician-gynecologist based in Orange County, California, who helped review the evidence for the American College of Obstetricians and Gynecologists. “It did not reflect the preponderance and overall weight of the data, and it did not reflect the clinical context.”

DeNicola, who has expertise in environmental exposures and health policy, pointed out that consensus authors didn’t include numerous reviews, including those from major medical organizations, that drew different conclusions. Both ACOG and the Society for Maternal-Fetal Medicine, for example, found no clear evidence that acetaminophen causes fetal developmental issues and no reason to change current medical advice and practice.

In the end, neither did the FDA. In 2018, the agency brought the issue before its Medical Policy and Program Review Council, which provides oversight and direction of policies. The council found the available data didn’t warrant changes on acetaminophen labels or updates to the existing safety communication, wrote FDA press officer Charlie Kohler in an email to Undark.

While the agency continues to monitor the issue, it closed the formal tracking process in 2020 said Kohler, because extensive reviews failed to turn up solid evidence of a link between the drug and neurodevelopmental issues.

The gold standard for understanding the effect of a medication is to randomly assign one group to take the drug and another to get a placebo, with neither researchers nor participants knowing who got what until the end of the study. However, those randomized clinical trials rarely include pregnant women because of potential risks to the fetus. As a result, acetaminophen researchers rely on observational studies and laboratory experiments, including those that test the effects of the drug on experimental animals.

It can be difficult, however, to study neurodevelopmental problems in these animals. For one, researchers wouldn’t diagnose ADHD or autism in a mouse, though some research finds that mice exposed to acetaminophen in the womb are more likely to have problems with learning, memory, motor skills, and social behavior. Additionally, the biological mechanisms that lead to a diagnosis in humans are complex and not well understood, said Kristensen, so researchers don’t know what to exactly look for when they study the brains of laboratory animals.

Research in test tubes and lab animals does show that acetaminophen affects several chemical systems involved in brain development. “The compound is doing multiple different things during development at specific time points when the fetus is vulnerable,” said Kristensen. But whether these factors contribute to neurodevelopmental problems, he added, is unclear. Kristensen said that he expects to publish data within the next year or so that could help clarify the connection.

It’s also hard to know what to make of the observational research, which has numerous limitations, according to DeNicola. Many of the studies rely on women’s recall of having taken acetaminophen, which can be faulty weeks and even months later, he said. And instead of a clinical diagnosis of a child’s developmental or behavior disorder, studies often depend on assessments by parents and teachers, which sometimes differ.

One of the biggest issues with the observational research is failing to adequately control for other factors that cause autism and ADHD, particularly heredity, said Per Damkier, head of research in clinical pharmacology at the University of Southern Denmark and a co-author of a consensus rebuttal by the European Network of Teratology Information Services. (Teratology is the study of diseases and conditions that are congenital, or present at birth.) Based on data from Western countries, researchers estimate that up to 80 percent of autism and up to 90 percent of ADHD results from genes children inherited from their parents. If you don’t account for that huge factor, he said, “you inevitably will come up with misleading results.”

For example, a 2017 Pediatrics study included in the original consensus review found that the father’s use of acetaminophen increased a child’s risk of ADHD just as much as the mother’s use during pregnancy. While the researchers theorize that acetaminophen could have altered how the fathers’ genes work, Damkier said that the more likely explanation is that the analysis didn’t sufficiently adjust for heredity.

The pain or illness that prompts a woman to take a pain reliever may also skew the data. In their consensus rebuttal, authors from the Organization of Teratology Information Specialists point to the OTIS’ long-running MotherToBaby study, which found that compared to pregnant women who use acetaminophen for short periods, those who take it longer term report having more mental health conditions, including depression and anxiety, and are more likely to take antidepressants — all factors studies suggest are associated with ADHD and autism in children.

In a 2020 study, epidemiologist Reem Masarwa, then a postdoctoral fellow at McGill University in Montreal, and colleagues explored whether confounding factors such as heredity and maternal illness could be biasing acetaminophen research.

The group reanalyzed data from a meta-analysis Masarwa had published two years earlier, which had found a 35 percent increased risk of ADHD in children exposed to prenatal acetaminophen. This time the researchers stringently adjusted for parental ADHD and migraines in the mother.  The ADHD risk nearly disappeared.

‘There’s Something Biological Going On’

The consensus authors cite two studies that overcome the limitation of relying on a mother’s memory of acetaminophen use. The first, a 2019 study, tested umbilical cord blood for traces of acetaminophen and the second, published in 2020, measured acetaminophen in babies’ first bowel movement. Both found that the higher the prenatal exposure to acetaminophen, the greater the chance of a child receiving a physician diagnosis of a neurodevelopmental disorder.

“The beautiful thing about the new studies coming out is that the better the study, the stronger the associations,” said Kristensen. “Suddenly, you can see dose response, which is something we always look for because that argues that there’s something biological going on.”

However, both of those studies have drawbacks as well. Acetaminophen only lingers in the blood for a few hours, so the implication of the cord-blood study is that a single dose right before birth could have a dramatic effect on a child’s brain. Many experts find that result implausible.

Testing a newborn’s bowel movement may be a better measure as it is thought to reflect the mother’s use of acetaminophen during the last two trimesters of pregnancy. But as with some other observational studies, the researchers didn’t account for why the mother took the drug in the first place.

Plaintiff attorney Ashley Keller said that his first responsibility is to help his clients win compensation. In addition, he said, there’s also a public health issue at stake in that the women need full information to make informed decisions.

In April, U.S. District Judge Denise Cote, who is presiding over the pre-trial proceedings, took the unusual step of inviting federal regulators to provide an opinion on whether the science warrants adding a warning to acetaminophen labels about an association between prenatal exposure and ADHD and autism.

The FDA declined to comment on whether the agency would weigh in by the end of July as requested by Judge Cote.

Claiming that FDA regulations and federal laws prevent them from changing Tylenol labels, Johnson & Johnson is pushing for a dismissal. The company continues to evaluate the science and has not seen any evidence that acetaminophen use during pregnancy causes fetal development issues, Witt, the company spokesperson, wrote in an email. “Leading medical organizations agree with the current product label which clearly states, ‘If pregnant or breast-feeding, ask a health professional before use.’”

Bauer said the lawsuits are helping get the word out about the accumulating research on acetaminophen’s risks. Up until now, she said, a lot of women have viewed the drug as “completely innocuous,” something to take “whenever they are in discomfort.” Others disagree. DeNicola said that the women he sees in his practice are conscientious about using acetaminophen.

One thing everyone agrees on is the recommendations for acetaminophen use, said DeNicola: “Use it only where indicated in the lowest dose for the shortest duration.” So, for pain or fever that means taking one pill, one time, to see if symptoms ease, he said.

Another point of real consensus is the need for more research. Bauer said that several groups are looking at possible mechanisms for how acetaminophen could affect development. “As far as the epidemiology, there’s a pretty perfect study that could be done,” she said, pointing out that, with smartphones, women can easily record what they take and why. “But it’s going to take us many, many years is the problem.”

“Something that is potentially this important for, not just fetal, but for childhood brain development should be studied,” DeNicola said. “And it should be studied in a real way.” For example, he would like to see studies that use blood tests and other measures throughout pregnancy to accurately track exposures not just to acetaminophen, but also to environmental substances of greater concern to fetal development, such as industrial chemicals. And, since a baby’s brain continues to develop after birth, studies should account for use of acetaminophen in childhood — a glaring omission from most of the current research, said DeNicola.

At the moment, no one is conducting exactly that type of study on acetaminophen.

However, FDA spokesperson Charlie Kohler said that agency is conducting a small study to see how people’s bodies absorb, metabolize, and excrete the drug. The agency is also planning a toxicology study in 2024, pending approval of funding.

And Chambers said that she is coordinating a study funded by the National Institutes of Health of about 8,000 mother-child pairs in 25 sites across the U.S. The Healthy Brain and Child Development Study will capture information on prenatal exposures, including to acetaminophen, and use brain imaging and standardized assessments to track brain development in children. Researchers will release data annually, so information on prenatal exposure to acetaminophen will begin to emerge in the next couple of years, she said.

If there’s anything good to come out of the controversy, it’s that every drug, over the counter or not, deserves rigorous research on safety, said Chambers — and society hasn’t invested in systematically doing that type of research. She pointed out that while the FDA requires new drugs to be assessed for safety during pregnancy, nobody has the resources of motivation to do that for old drugs like acetaminophen.

“And we need to stop that,” said Chambers. “We need to turn that wheel around, pay attention and do the work that needs to be done.”

This article was originally published by Undark, a non-profit, editorially independent online magazine covering the complicated and often fractious intersection of science and society. You can read the original article here.

‘Take Care of Maya’: The High Cost of a Mother’s Love

By Cynthia Toussaint, PNN Columnist

Netflix’s top-notch documentary, Take Care of Maya, was excruciatingly painful for me to watch because it hit so close to home. I related on many levels: the disease, maltreatment from healthcare professionals, being labeled crazy, the family breakdown, and the pursuit of justice. But the dagger to my heart was the price paid for a mother’s love.

Like me, the protagonist, Maya Kowalski, has Complex Regional Pain Syndrome (CRPS), but the over-riding message of the film is about something far more insidious. It lays out the abusive extremes some health and social care systems take to make a buck at the cost of patients and their families. Sometimes that price can be unimaginable.

In Maya’s case, her parents were falsely accused of child abuse, specifically making their daughter ill for their own gain, a disorder known as Munchausen by Proxy. This misguided allegation led to Maya being kidnapped by hospital administrators, who then barred her from seeing her family, all while the 10-year-old’s physical and emotional pain became increasingly worse.

It was horrifying to watch Maya’s family unravel under the strain of this prolonged nightmare, in particular her bold and unflinching mother Beata’s relentless confrontations with the powers that be.

After multiple failed attempts to reverse matters in the courts, Beata, the focus of the abuse allegations and the target of the hospital’s ire (***spoiler alert***), became increasingly despondent to the point that she hanged herself to give her daughter the best chance of getting back home.

‘They’re Killing My Daughter’

I’m guessing that many who watched the documentary found its facts too fantastic to be true – and there was a time when I might have agreed with them. But I’ve lived too much of this story to question it now.

In my early 20’s, when it was clear that my still unnamed disease wasn’t going away, my mother became progressively distraught over watching my life slip down the rabbit hole. It’s fair to say my recovery came to be her over-riding obsession.

Mom wrote 200+ searing letters, sometimes demanding, at other times begging my HMO to diagnose and treat me. She spent large swaths of those years on the phone in desperate attempts to get me, as she coined them, “no-care” appointments, all in the hope that a compassionate physician or administrator would at last hear her pleas and change my course.

My poor mother became more and more unglued and unwell from the abuse, aimed first at me and then toward her, from this evil empire. She developed life-threatening heart problems and her legs, addled by aching varicose veins, went from bad to worse from constantly lifting me. Perhaps my most distressing memory of those dark days was when I’d hear her full-volume moans emanating from out-of-control sadness.  

One day after my HMO dropped the ball on an appointment we’d driven miles to attend, Mom snapped with rage. With super human strength, she hoisted my 50-pound wheelchair in the parking lot and smashed it into her car. As I cried in fear, she repeatedly bashed away.

“They don’t care about my daughter!” she screamed. “She’s dying! They’re killing my daughter!”

During this time, I was terrified for my mother’s life. Though it never crossed my mind she would take her own, I was hounded incessantly with the thought that she would succumb to a stroke or heart attack.

Maya’s mother made the ultimate sacrifice by taking her own life to save her daughter’s. Some might say that was tragically misguided, but I’m certain Beata’s intentions were true and real. My mother said to me on more occasions than I care to remember, “If cutting off my arm would make you well, I’d do it.” I never doubted her.

After fighting my HMO for nearly a decade with no tangible results, not even a diagnosis, my mom pulled up stakes, but in a different way than Beata. Mom moved to New York to pursue her long-delayed acting career. When I confronted her about feeling abandoned, she explained her reasoning. “Maybe if I go, you’ll get better by doing more for yourself,” she told me. It didn’t have to be logical.

In Beata and my mother’s desperation to somehow, someway fix impossibly tragic situations for their daughters, both made questionable choices out of love. It’s true, the path to hell is paved with good intentions, especially where chaos and heartbreak intersect.

Like Maya, I couldn’t just fold tent and walk away from the institution that did me wrong. Sure, I wanted justice for me, but also for my mom. I became a spokesperson and a whistle-blower for HMO reform in California, hell bent on exposing all of their atrocities. I did get a number of licks in, multiple high-profile media stories that helped change public opinion, which helped pave the way to sweeping legislative reform.

In retrospect, something I think of quite a bit these days, the cost was too high. I’m harassed by this entity to this day and they were successful in killing much of my most important work. In short, the fallout from my justice-seeking made me sicker and sadder over the decades, taking away more than it gave.

When I see Maya seeking justice in her mother’s name, I have great respect for her, but also concern. This young woman is now in remission and, going forward, my prayer is that she puts her health front and center. After poignantly telling her story on a world stage and prevailing in the courts (which I believe will mercifully happen soon), I hope Maya will step away with the knowledge that she’s done enough, and never looks back. It’s time to save herself.     

It’s also time to grieve, maybe more than anything, the loss of a mother’s love.    

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome (CRPS) and 19 co-morbidities for four decades, and has been battling cancer since 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.”

5 Lessons I’ve Learned About Chronic Pain

By Barby Ingle, PNN Columnist

Do you ever feel like your time, energy and hope are running out due to chronic pain or illness? That you aren’t living life to the fullest and may never be able to?

Many people who live with painful disabling conditions have that kind of fear and self-doubt. If you are struggling with similar thoughts, read along while I dive into the five most meaningful lessons I’ve learned about chronic pain.

I wish I had known these things when my journey through the American healthcare system began. I strive to be healthier and wonder if my wellness would be further along if I had known better from the start.

The good news is that changing today can affect your tomorrow. It is never too late to make improvements in your life. Whether you are a longtime chronic pain patient or just starting on your pain journey, these five insights may help save you some heartache and frustration. 

1.  Keep good medical records 

I have long been a proponent of keeping and updating your medical records.  Use technology to your advantage. Advances in health information technology make it easy to store and retrieve data, and facilitates the rapid exchange of patient information. This can help you file insurance appeals and when seeking prior authorizations.

When a provider closes down unexpectedly, having medical records from your patient portal either printed or downloaded in PDF form can also help you find a new provider. This is something I faced this year when my ketamine provider abruptly shut down.  

2.  Not all providers are equal 

Learn everything you can about your illness and keep learning. It is also essential to seek specialists who know about your complex medical condition.

People often look up to their doctors and put total faith in them. However, most doctors are educated and trained in only one specialty in the practice of medicine. Just because a doctor is a neurologist doesn’t mean they can treat diabetic neuropathy, multiple sclerosis or Lyme disease. 

Providers may have expertise in treating one or two conditions, and know only a little about others. With thousands of diseases, conditions and treatments, no provider can know them all in-depth. Learn about your provider's experience and limitations, and encourage them to seek additional knowledge from their peers to help you. Communication is the key to improving trust and faith in your treating doctors.

3.  Your diagnosis does not define you 

In medicine, a diagnosis refers to a specific disease or illness, but not the characteristics of each patient. A condition may present itself and progress differently, depending on the patient’s genetics, lifestyle and environment.

I was once given a diagnosis of thoracic outlet syndrome (TOS) when I was exhausted, over-treated, and scared. It turned out that was an incorrect diagnosis and that the TOS-like symptoms I was having were secondary to the real cause: Reflex Sympathetic Dystrophy (RSD).  

We need to be careful not to jump to easy conclusions. I also realized I had to stop comparing my symptoms and outcomes to others with the same condition. I turned my focus on creating the best me I could be. 

4.  If something is too challenging, break it into smaller pieces 

Do the more manageable actions first, and then see what is left to conquer.

Tackling one problem – like organizing medical records from a single provider -- can give you the positive momentum to take on the more challenging ones. If you find yourself having difficulty -- stop, take a break and work on something else. Get that feeling of success (and the endorphins that come with it), and return to the challenge when you are ready for it. 

5.  Share your journey 

Each of our journeys are unique, but hearing someone else’s experience can offer us hope, options, and ideas that we can use to improve our own lives.

For example, I’ve found that hydration is super essential for coping with RSD. My primary care doctor said I should drink water regularly to help regulate my body temperature, keep my joints lubricated, prevent infections, replace nutrients in my cells, and to keep my organs functioning correctly.

He was right. I learned that when I consistently drink 60-70 oz. of water daily, take my medications on time, and do light stretching, my sleep, cognition and mood also improve.

Continue to share and cultivate habits that support your long-term health and happiness. The more we know, the better our decisions will be. I’ve dedicated my life to helping people with chronic conditions have happier and more meaningful lives. The key is to believe in yourself while building the life that you want. After helping thousands of people worldwide and reading countless success stories, I am confident that you can do that.

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and best-selling author on pain topics. Barby has received over 25 awards for her advocacy efforts. You can follow her at www.barbyingle.com.    

Arthritis Pain Varies Widely Across States

By Pat Anson, PNN Editor

People living in West Virginia are three times more likely to have moderate or severe joint pain from arthritis than those in Minnesota, according to a comprehensive new study that highlights how disparities in education and access to social services contribute to chronic pain.

“Very little research has examined the geography of chronic pain, and virtually none has examined the role of state-level policies in shaping pain prevalence,” says co-author Hanna Grol-Prokopczyk, PhD, an associate professor of sociology at the University of Buffalo. “We were excited to identify state characteristics that reduce residents’ risk of pain.”

Grol-Prokopczyk and her colleagues looked at data for over 400,000 adults who participated in the 2017 Behavioral Risk Factor Surveillance System, along with data from all 50 states on social assistance and anti-poverty programs such as the Earned Income Tax Credit, Medicaid and Supplemental Nutrition Assistance Program (SNAP), more commonly known as food stamps.

Their findings, published in the journal PAIN,  show the risk of joint pain was significantly higher in states in Appalachia, the Mississippi Valley and the South, compared to states in the Upper Midwest and West.

Nearly one in four adults in West Virginia (23.1%), Alabama (21.6%) and Arkansas (21.4%) had moderate to severe joint pain. States with the lowest risk of joint pain are Minnesota (6.9%), Hawaii (7.5%) and Utah (7.7%).

SOURCE: PAIN

Digging deeper into the data, researchers found that educational disparities are also associated with pain frequency. People who did not complete high school in West Virginia (31.1%), Arkansas (29.7%) and Alabama (28.3%) were far more likely to have joint pain compared to those with bachelor degrees in California (8.8%), Nevada (9.8%) and Utah (10.1%).

People with less education are more likely to have blue-collar jobs requiring manual labor that may contribute to joint pain. They also have lower incomes and less access to healthcare.

“Education can function as a ‘personal firewall’ that protects more highly educated people from undesirable state-level contexts, while increasing the vulnerability of less educated individuals,” said first author Rui Huang, a sociology PhD student in the UB College of Arts and Sciences.

Researchers also found that states with higher levels of SNAP benefits, social support and community health services had lower levels of pain frequency.

“The increase in the generosity of SNAP benefits could potentially alleviate pain by promoting healthier eating habits and alleviating the life stress associated with food insecurity,” says Huang. “Social factors such as conflict, isolation and devaluation are also among the ‘social threats’ that can lead to physical reactions such as inflammation and immune system changes.”

Previous studies at the University of Buffalo have found that gender, poverty and education play a role in pain frequency and that the overall prevalence of pain is increasing in the United States, affecting virtually every age group, sex, ethnicity and demographic.

Should Suboxone Be Used to Treat Kratom Addiction?

By Pat Anson, PNN Editor

A man with a history of substance abuse – including addiction to kratom – has been successfully treated with buprenorphine/naloxone (Suboxone), according to a case study published in the journal Cureus.  Suboxone is a medication that is normally used to treat opioid use disorder.

Kratom is not derived from the opium poppy and is not an opioid. It’s an herbal supplement that comes from the leaves of a tree in southeast Asia, where it has been used for centuries as a stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and use it to self-treat their pain, anxiety, depression and addiction.

The unidentified patient in the case study has a history of using cocaine, marijuana and alcohol, and suffers from anxiety and depression. He was introduced to kratom 12 years ago by his brother for stress relief and as a substitute for oxycodone. Over the years, the patient used more and more kratom, at one point spending up to $600 a week on kratom supplements.

After several failed attempts to wean himself off kratom, which resulted in severe withdrawal symptoms, the patient went to see his primary care physician, Dr. Paul Remick, one of the study’s co-authors. It was Remick who suggested that Suboxone might help him quit kratom.

“He’d been struggling with depression, anxiety, all these various issues. He was pretty reluctant to try therapy like Alcoholics Anonymous or trying to speak to a therapist,” explained lead author Martin Arhin, a medical student at the University of North Carolina at Chapel Hill. “Dr. Remick suggested Suboxone, since kratom has some like opioid-like properties. He felt like it could potentially work. And fortunately, it did.”

After 23 weeks of using Suboxone, the patient’s withdrawal symptoms subsided and he stopped using kratom. He’s also been successfully tapered off Suboxone, a drug that many people wind up taking for life.   

Suboxone is only approved for opioid use disorder and there is no clinical evidence that it can treat kratom addiction. Such a use, while legal, would be considered “off-label” by the FDA. But based on this one anecdotal case, Arhin and his co-authors say Suboxone could be a treatment for kratom dependence.

“Currently, there is no established evidence-based consensus for the treatment of kratom addiction and withdrawal, leaving individual providers to decide on the appropriate course of action,” they wrote. “We recognized the patient's dependency on kratom and subsequently implemented a treatment plan utilizing buprenorphine/naloxone, which effectively alleviated withdrawal symptoms and supported the patient's abstinence from kratom. We suggest that this drug combination may be a potential treatment for kratom addiction.”

‘Kratom Saved My Life’

Ironically, many people use kratom as an alternative to Suboxone. In a 2016 PNN survey of over 6,100 kratom users, nearly ten percent said they used kratom primarily as a treatment for opioid addiction. Most said it was very effective (91%) in easing their withdrawal symptoms and worked better than Suboxone, with fewer side effects.

“Kratom saved my life. I tried every other type of treatment for drug addiction over the past 10 years. Subutex, methadone, total abstinence and the 12 step program. Each time I failed. After 2 years of Suboxone, I stopped treatment and began using kratom,” one respondent told us.

“Because of kratom, I no longer have to worry about heroin (or methadone or Suboxone) making me sick. I've been clean for 2 years. I can hold a job now, and I only use it when I need pain relief or need to relax,” another respondent wrote.

“I became hooked on oxycodone and had to take Suboxone to get off it. The problem is Suboxone withdrawals were nearly as bad, so I used kratom to cure that,” another patient said.

“Kratom truly saved my life. I've always suffered from extreme anxiety, but it has decreased drastically since taking it. Withdrawals from opiates and Suboxone are awful. I would not have been able to get clean without kratom. I'm confident in saying that if you make kratom illegal, the number of overdoses will rise,” wrote another kratom user.

The DEA and FDA have tried to make kratom illegal by having it declared a Schedule I controlled substance. So far, those efforts have failed due to a public backlash.

Kratom is sold legally in most U.S. states, but a handful of states and cities have banned it over concerns about addiction and overdoses.  About 100 deaths nationwide have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.

About two million Americans use kratom, primarily to treat chronic pain. A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

Although many people use kratom to self-treat opioid addiction and ease withdrawal symptoms, the FDA won’t allow kratom vendors to advertise or promote kratom for addiction treatment or any other medical purpose. This month, the FDA sent a warning letter to the Sunshine Trading Company in Colorado, warning it to stop promoting its kratom products for “opiate withdrawal.”

“You market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses. Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal,” the FDA said.

In recent years, several other kratom vendors have received similar warning letters from the agency..

Home Delivery of Rx Opioids Would Help Chronic Pain Patients

By Pat Anson, PNN Editor

We hear almost every day from people in pain who say they can’t get an opioid prescription filled because their pharmacy is out of stock. Often, the pharmacist has no idea when the next shipment of pain medication is coming.

“Walgreens cannot fill my prescription. They say the drug is on back order with no ship date available,” a patient recently told us.

“20 years on the same Rx for Vicodin and now CVS says they are out of stock and no idea when it will be available,” another patient wrote.

“Just talked to a pharmacist today that said they are out of Percocet, Vicodin and morphine. They said that their supplier, Cardinal Health, wasn't sure when they would get more,” said another patient.

Now imagine, if you will, what it would be like to have a pharmacy that delivers opioid medication directly to your home. No more standing in line at the pharmacy. No more dirty looks from the pharmacist. No more excuses about being out of stock.

For about 1,000 patients in the Philadelphia area, most of them chronic pain sufferers, that fantasy is a reality. They are customers of a boutique pharmacy in the Delaware Valley that specializes in home deliveries of controlled substances – including high dose opioids.  Prescriptions and refills are delivered on a carefully managed schedule before a patient runs out, becomes disabled by uncontrolled pain, and goes into withdrawal.

“We hand deliver directly to the patient. I have a whole delivery team. They're our own drivers, our own vehicles,” says Brian Dunleavy, CEO of PMC Pharmacy. “Our customers get notified when their delivery is anticipated to arrive at their home. And then every patient has to sign for it. They have to be present or we can't leave it there. Or it has to be an adult that's been authorized to receive the medication.”

I first heard of PMC Pharmacy when it sent out a news release last month to address difficulties that some patients have getting opioids and other controlled medications from other pharmacies in the Delaware Valley. PMC said it could help those patients avoid gaps in drug therapy and was committed to keeping them “on schedule, at home, and independent.”

“We should really have every chronic pain management patient in the Delaware Valley under our care because of the way our program works,” Dunleavy told PNN.

While big chain pharmacies and their wholesale drug suppliers are under increased scrutiny from law enforcement and regulators, PMC flies under the radar because its customers’ medical conditions, prescriptions and insurance claims are carefully documented – reducing the risk of diversion or misuse.     

“We won't take patients from a typical primary care practice, we're only working with chronic pain specialists who give us (patient) chart notes and supporting documentation to satisfy our wholesalers’ desires that we're doing due diligence on all these doctors and all these patients, and making sure that there's a legitimate need for the medication,” Dunleavy explained. “The diversion isn't coming from the people that are legitimate chronic pain patients. Those people hold onto that medication as if it's their lifeline.”

Trifecta of Problems

The supply of opioids and other controlled substances is tight because of a trifecta of problems that have hamstrung the pharmaceutical industry.

First, the Drug Enforcement Administration has been aggressively cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by 65% and hydrocodone by 73% since 2013.

Second is the fallout from opioid litigation. The nation’s three largest drug wholesalers reached a $21 billion settlement with 46 states, requiring them to impose strict limits on opioid shipments to pharmacies. CVS, Walgreens and other pharmacy chains have also paid tens of billions of dollars to settle lawsuits that alleged they helped fuel the overdose crisis by dispensing too many opioids.  

The third reason for tight supplies is a retooling of the generic drug industry. There’s little money to be made in selling most opioids and there’s a risk of further liability, so drug makers are cutting back production of many generic opioids.  One of the world’s largest manufacturers of generics, Teva Pharmaceutical, recently notified the FDA that it was discontinuing production of oxycodone.

It all adds up to an increasing number of drug shortages, involving not just opioids, but medications used to treat cancer, anxiety and attention deficit disorder. Dunleavy thinks the shortages are a direct result of regulatory overreach.

“You have all these things going on and everybody's like, ‘Oh well, there's a shortage of oxycodone out there.’ And in actuality, there isn't. It's a regulatory created shortage, which is why there's a discrepancy between what we're hearing from patients versus what we see at the on the wholesalers’ shelves,” he explained. “The pharmacies can't get those drugs because they're quantity restricted by the wholesalers, based on the programs that the wholesalers have implemented to police the pharmacies.”

Dunleavy says PMC would like to add more patients to its customer base, provided they live in its delivery area in southeastern Pennsylvania and parts of New Jersey and Delaware that border Philadelphia. He’s confident he’ll be able to get the additional medication from suppliers.

“You're not going to have a better adherence and compliance program from a pharmacy than ours,” he said. “Because our program is pain management specific, once we start working with a practice, we start getting quite a few referrals. So it's very easy for us to start growing.”

Could PMC’s business model be adopted by other pharmacies? With pain management under so much scrutiny, Dunleavy says home deliveries to selected patients make sense.

“There's a legitimate need for a pharmacy that puts in a little bit more effort, that's a little bit more specialized. Because the regulatory environment requires it, the patients require it, and the physicians require it,” he said.

“This is a very interesting concept. It almost sounds too good to be true, but if it really works it would be tremendously helpful to many chronically ill people,” says Kristen Ogden, a patient advocate in Virginia. “I think this concept may be really helpful to house-bound patients and persons with limited access to transportation, especially those who don't have an engaged family member helping them.”  

For many years, Kristen and her husband Louis have traveled to California to get the high dose opioids he needs to treat severe pain from arachnoiditis and Ehlers-Danlos Syndrome. Not having to make that monthly cross-country trip for refills would be a welcome relief to the Ogdens.  

“It would be great to think this sort of service would be available to us as we get older, especially since we have no children and no other family members who live in our area to assist us. This could certainly be a big factor in enabling older adults to continue living in their own homes if that's what they prefer to do,” Kristen said. 

The American Society of Health-System Pharmacists put immediate release oxycodone on its list of drug shortages in March and added hydrocodone/acetaminophen tablets to the list in May.  Neither shortage has yet to be recognized by the FDA, although many patients are already well aware that both medications are in short supply. 

“I've been waiting for over a week for oxycodone to come in. Over the last weekend, I went to over 25 different pharmacies searching, until I couldn't drive anymore. It's not fair to any of us!” a pain patient recently told PNN