Beyond Counterfeit Ozempic

https://www.medpagetoday.com/special-reports/features/112421

Criminals have found ways to sell illicit weight-loss drugs through counterfeits and drug diversion, where drugs are altered or shipped from overseas, according to CNBC opens in a new tab or window.

Drug diversion is a different beast than counterfeit weight drugs, sources said. People may get the real product, unlike counterfeits, but there are still substantial risks.

As part of the investigation, CNBC ordered Ozempic from Laver Beauty, a company based in Boulder, Colorado, that sells a month’s supply for $219 rather than the usual $968. The shipment arrived from China to New Jersey with no refrigeration apart from melted ice packs. Novo Nordisk said the product looked legitimate, though authorized for a Chinese market and the company “cannot confirm the sterility, which may present an increased risk of infection for patients who use the counterfeit product.”

Much of the questionable product is ordered from online shops and social media and illicit sellers are getting better at making convincing packaging.

Sal Ingrassia, the port director overseeing U.S. Customs and Border Protection at New York’s JFK Airport, also reviewed the package and said it was clear the shipment had “broken the legal supply chain.” At JFK there have been 198 Ozempic, 9 Wegovy, and 1 Mounjaro seizures since the start of the year, according to CNBC, though this doesn’t necessarily equate to counterfeits or diverted product. Ingrassia said this is double from last year.

A four-week supply of the 2.5 mg Zepbound single-dose vial is $399 ($99.75 per vial), and a four-week supply of the 5 mg dose is $549 ($137.25 per vial) – less than half the list price of other incretin medicines for obesity and in line with the Zepbound savings program for non-covered individuals.

Lilly releases Zepbound® (tirzepatide) single-dose vials, expanding supply and access for adults living with obesity

https://investor.lilly.com/news-releases/news-release-details/lilly-releases-zepboundr-tirzepatide-single-dose-vials-expanding

Distributed through LillyDirect^®‘s self-pay channel, Zepbound single-dose vials are at least 50% less than the list price of all other incretin medicines for obesity

INDIANAPOLIS, Aug. 27, 2024 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced Zepbound^® (tirzepatide) 2.5 mg and 5 mg single-dose vials are available for self-pay for patients with an on-label prescription, significantly expanding the supply of Zepbound in response to high demand. The single-dose vials are priced at a 50% or greater discount compared to the list price of all other incretin (GLP-1) medicines for obesity. This new option helps millions of adults with obesity access the medicine they need, including those not eligible for the Zepbound savings card program, those without employer coverage, and those who need to self-pay outside of insurance.

“We are excited to share that the Zepbound single-dose vials are now here, further delivering on our promise to increase supply of Zepbound in the U.S.,” said Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA. “These new vials not only help us meet the high demand for our obesity medicine, but also broaden access for patients seeking a safe and effective treatment option. In a clinical study, the 5 mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off.”

Lilly has created a new self-pay pharmacy component of LillyDirect where patients with a valid, on-label prescription from the health care provider of their choice can purchase the vials. Distributing the vials via this channel ensures patients and providers can trust they are receiving genuine Lilly medicine, building on the company’s efforts to help protect the public from the dangers posed by the proliferation of counterfeit, fake, unsafe or untested knock-offs of Lilly’s medications. Lilly has also taken a vocal stance against the use of obesity medicine for cosmetic weight loss; a multi-step verification process will help ensure the vials are dispensed only to patients who have a valid, on-label electronic prescription from their health care provider. Patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.

“People living with obesity have long been denied access to the essential treatment and care needed to manage this serious chronic disease,” said James Zervos, chief operating officer, Obesity Action Coalition. “Expanding coverage and affordability of treatments is vital to people living with obesity. We commend Lilly for their leadership in offering an innovative solution that brings us closer to making equitable care a reality. Now, it’s time for policymakers, employers and insurers to work with pharmaceutical companies to ensure no one is left behind in receiving the care they deserve and need.” 

A four-week supply of the 2.5 mg Zepbound single-dose vial is $399 ($99.75 per vial), and a four-week supply of the 5 mg dose is $549 ($137.25 per vial) – less than half the list price of other incretin medicines for obesity and in line with the Zepbound savings program for non-covered individuals. The self-pay channel enables a transparent price by removing third-party supply chain entities and allowing patients to access savings directly outside of insurance.

“Despite obesity being recognized as a serious chronic illness with long-term consequences, it’s often misclassified as a lifestyle choice, resulting in many employers and the federal government excluding medications like Zepbound from insurance coverage,” said Jonsson. “Outdated policies and lack of coverage for obesity medications create an urgent need for more innovative solutions. Bringing Zepbound single-dose vials to patients will help more people living with obesity manage this chronic condition. We will also continue to advocate for a system that better aligns with the science.”

In a clinical study, tirzepatide 5 mg, along with a reduced calorie diet and increased physical activity, achieved an average of 15% weight loss over 72 weeks compared to 3.1% for placebo. Zepbound is the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or those who are overweight and also have weight-related medical problems, to lose weight and keep it off. Zepbound should be used with a reduced-calorie diet and increased physical activity. It should not be used in children under 18 years of age or with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. Zepbound has not been studied in patients with a history of pancreatitis, or with severe gastrointestinal disease, including severe gastroparesis, and it is unknown if patients with a history of pancreatitis are at higher risk for developing pancreatitis on Zepbound.

Zepbound is also available in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 ml doses in a single-dose pen (autoinjector). The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly.

To learn more about the Zepbound single-dose vial, please visit Zepbound.lilly.com.

To learn more about LillyDirect, please visit: LillyDirect.lilly.com.

INDICATION AND SAFETY SUMMARY WITH WARNINGS
Zepbound^® (ZEHP-bownd) is an injectable prescription medicine that may help adults with obesity, or with excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.

Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if Zepbound can be used in people who have had pancreatitis. It is not known if Zepbound is safe and effective for use in children under 18 years of age.

Warnings – Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).

Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.

Zepbound may cause serious side effects, including:
Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Kidney problems (kidney failure). Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration.

Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.

Depression or thoughts of suicide. You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

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90% of independent pharmacies may not stock drugs in negotiation program: Study

https://www.beckershospitalreview.com/pharmacy/90-of-independent-pharmacies-may-not-stock-drugs-in-negotiation-program-study.html

A new survey by the National Community Pharmacists Association found that more than 90% of independent pharmacists may refuse to sell drugs targeted by Medicare Part D negotiations, potentially jeopardizing the Biden administration’s efforts to lower prescription costs. 

The survey, conducted from Sept. 24 to Oct. 11, found that 51% of pharmacists are strongly considering not stocking drugs due to inadequate reimbursements from pharmacy benefit managers, with another 40% considering the same, according to an Oct. 14 NCPA news release shared with Becker’s.

The Medicare Drug Price Negotiation Program is set to begin in January 2026, but many pharmacies could face drug flow issues, needing to cover $27,000 monthly to stock the medications without guaranteed timely reimbursement. 

As low reimbursements can affect the viability of independent pharmacies, 73% of pharmacists have not finalized their contracts for 2025, raising concerns as open enrollment begins Oct. 15. 

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Lubetsky v. United States

https://ronaldwchapman.com/blog/lubetsky-supreme-court

By: Ronald W. Chapman II

Dr. Ronald Lubetsky, a Florida physician, takes aim at the Controlled Substances Act in a new Supreme Court petition filed on August 5, 2024. His case is both shocking and tragic but his fight is not over.

The government’s prosecution of Dr. Lubetsky centers around the ambiguous language of the CSA, particularly the phrase “outside the usual course of his professional practice, other than for a legitimate medical purpose.” The government has moved away from the original intent of the CSA, which was to target drug trafficking, and instead has begun prosecuting physicians based on increasingly vague and shifting standards of medical practice.

At trial, the government’s medical expert, Dr. Rubenstein, testified that Dr. Lubetsky’s prescriptions were issued outside the usual course of professional practice. This testimony was based solely on audio recordings of the patient visits and did not include a review of any medical records, diagnostic imaging, or the patient’s prescribing histories.

Rubenstein’s testimony was based solely on audio recordings of the patient visits and did not include a review of any medical records, diagnostic imaging, or the patient’s prescribing histories.

Dr. Rubenstein asserted that the lack of a detailed physical examination and comprehensive medical history in these specific cases rendered the prescriptions illegitimate. However, this opinion was formed without considering the full context of Dr. Lubetsky’s practice and the treatment of thousands of legitimate pain patients.

The Circuit Split and Post-Ruan Interpretation

A key legal issue in Dr. Lubetsky’s case is the circuit split over how the ambiguous language of the CSA should be interpreted. Specifically, courts are divided on whether the requirement for a prescription to be issued “for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice” should be read conjunctively or disjunctively.

• Conjunctive Reading: Under this interpretation, both elements—issuing for a legitimate medical purpose and acting in the usual course of professional practice—must be satisfied for a prescription to be considered lawful.

• Disjunctive Reading: Under this interpretation, a prescription could be deemed unlawful if it fails to meet either of these elements. This reading lowers the threshold for criminal liability, as a physician could be prosecuted even if they prescribe for a legitimate medical purpose but allegedly do not follow the usual course of professional practice.

The Eleventh Circuit, where Dr. Lubetsky was tried, has adopted the disjunctive reading. This approach has significant implications, as it allows the government to prosecute physicians even when there is no clear evidence that the prescriptions were issued for anything other than a legitimate medical purpose. This interpretation is in conflict with other circuits that have adopted the conjunctive reading, which provides greater protection to physicians by requiring that both elements be proven before a conviction can be secured.

The Supreme Court’s decision in Ruan v. United States was expected to clarify this issue, but it has instead led to further narrowing by the U.S. Circuit Courts. In Ruan, the Court recognized the ambiguity in the language of the CSA and highlighted the importance of a strong scienter requirement to avoid overdeterrence. Despite this, the Eleventh Circuit has continued to uphold the disjunctive reading, creating a situation where physicians are left with little clarity on the standards they must meet to avoid criminal liability.

Government’s Shifting Standards

Dr. Lubetsky’s case also underscores a troubling trend: the government’s shifting standards for what constitutes acceptable medical practice under the CSA. Historically, the CSA was used to target physicians who were clearly engaged in drug trafficking—those who prescribed controlled substances without any medical justification, often to patients who explicitly stated they intended to use the drugs for non-medical purposes. However, in recent years, the government has broadened its interpretation of the CSA, prosecuting physicians based on vague and unenumerated standards of medical practice that often go beyond what state laws require.

In Dr. Lubetsky’s case, the government’s expert applied a standard for prescribing that exceeded Florida’s requirements. Florida law mandates that a complete medical history and physical examination must be conducted before beginning opioid treatment, but there is no requirement for a physical examination at every follow-up visit. The expert, however, testified that a physical examination was required at every visit when opioids were prescribed, thus holding Dr. Lubetsky to a higher standard than what is legally required in the state.

This evolving and inconsistent application of standards places physicians in an untenable position, where they must navigate not only state laws but also fluctuating federal expectations that may not align with established medical practices. The consequence is a chilling effect on the practice of pain management, where doctors may avoid prescribing necessary medications out of fear of prosecution, leaving patients to suffer.

Interested Parties May File an Amicus Brief with the Court

Given the complex legal and medical issues at play in this case, it is imperative that advocacy groups concerned with patient care, medical ethics, and physician rights take action. Filing amicus briefs in support of Dr. Lubetsky’s petition to the Supreme Court is crucial to ensure that the Court fully understands the broader implications of this case. These briefs can help the Court appreciate the potential harm of allowing ambiguous and overly stringent interpretations of the CSA to persist.

Dr. Lubetsky’s defense counsel and authors of the brief are Ronald W. Chapman II and Matthew Pelcowitz of the Chapman Law Group.

PDF of the 75 page filing  click here

 

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This is a post from Dr Mark Ibsen.  Mark has been caring for a dozen or so of what has been labeled as “opioid refugees”. The only pharmacy that he could find that would fill the opioid Rxs from Dr Ibsen was in FLORIDA and that pharmacy unfortunately got “trashed” by those two different hurricanes that hit Florida over the last few weeks and is temporarily “out of business”  Mark is looking for another pharmacy – preferably a compounding pharmacy – that Mark can reach out to.

Mark has these dozen or so intractable chronic pain pts that are in or on the verge of being thrown into a cold turkey withdrawal.

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Medicare Advantage star ratings decline: 5 things to know

https://www.beckerspayer.com/payer/medicare-advantage-star-ratings-decline-5-things-to-know.html

Average Medicare Advantage star ratings declined for the third year in a row, according to CMS data published Oct. 10. 

The average Medicare Advantage star rating for 2025 is 3.92, down from 4.07 in 2024. 

Plans must earn a rating of 4 or higher to receive bonus payments from CMS. 2025 star ratings affect the quality bonus payments plans receive in 2026. 

Here are five things to know about the star ratings: 

1. Just seven plans received a five-star rating in 2025, down from 38 in 2024.
2. Around 40% of Medicare Advantage-Part D plans received four stars or higher. Around 62% of MA-PD enrollees are in plans rating four or higher, according to CMS.
3. CMS did not make any major changes in star ratings methodology, according to the release.
4. Medicare Advantage-Part D plans are rated on 40 clinical quality and member service measures. CMS determines cut points for measure each year. For 2025, many cut points increased, meaning plans had to perform better to get higher star ratings.
5. Several factors influenced the tougher cut points, CMS said. The agency removed extreme outliers from the lower end of performance, a more compressed distribution on scores and an increasing number of high-scoring contracts. Some measures are improving to pre-pandemic levels, increasing cut points, CMS said.

Potential challenges to CMS’ star ratings could loom. Earlier in October, Humana said its star ratings for 2025 dropped significantly from 2024. In 2025, just 25% of its members will be in contracts rated plans four stars and above, down from 94% in 2024. The company said it expected the drop was driven by “narrowly missing industry cut points on a small number of measures.” In regulatory filings, the company said it believes there may be potential errors in CMS’ calculations. 

UnitedHealthcare is also challenging CMS’ star ratings. The company filed a lawsuit Sept. 30, challenging CMS’ inclusion of a secret shopper phone call in its star ratings that UnitedHealthcare said never connected. 

In June, CMS recalculated 2024 star ratings for all Medicare Advantage plans. Judges sided with SCAN Health Plan and Elevance Health in lawsuits challenging the methodology CMS used to calculate the ratings. 

In addition to determining bonus payments, star ratings guide beneficiaries’ decisions on which plan to enroll in. Open enrollment begins Oct. 15 and runs until Dec. 7.

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NCPA: Drug price negotiations will fail without fair and timely pharmacy reimbursement

https://ncpa.org/newsroom/qam/2024/10/07/ncpa-drug-price-negotiations-will-fail-without-fair-and-timely-pharmacy

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Helene Poses Big Problems for Mail Service in Western NC

https://www.theassemblync.com/politics/elections/mail-postal-service-ballots-medicine-hurricane-helene/

From medication to ballots, the U.S. Postal Service is a critical delivery method. Here’s what to know about the state of services following Hurricane Helene.

In the days since Hurricane Helene made landfall in Western North Carolina, about 1.2 million people have lost their postal delivery service, and could see that disrupted for weeks to come.

The U.S. Postal Service announced the suspension of mail delivery operations in the areas with zip codes beginning with 286, 287, 288, and 289, and has not given any updates on when it will resume.

The most obvious barrier is a lack of mailboxes or even homes to deliver to in flood-ravaged parts of the state. The North Carolina Department of Transportation also estimates as many as 390 road closures including parts of Interstate 40.

“Is there an address remaining to which it can be delivered?” said Thomas Birkland, the former director for the Infrastructure Management and Hazard Response program at the National Science Foundation. “Is there a functioning post office available to process the mail, to deliver it? Are there people available to deliver it? And are the roads open so that you can deliver the mail? If any one of those answers is no, then the mail is going to be delayed.”

Birkland said one way researchers measured the impact of Hurricane Katrina in 2005 was by assessing the extent to which mail was deliverable.

“If the house is destroyed, or the business is destroyed, there’s no point to which it can deliver the mail, and so [the postal service would] have to hold on to it,” Birkland said.

Philip Bogenberger, spokesperson for the North Carolina and Virginia districts of the U.S. Postal Service, said in a statement that the agency is working to restore delivery service to western North Carolina.

“The safety of our customers and employees is the Postal Service’s top priority in the aftermath of Hurricane Helene,” Bogenberger wrote. “At this time, we are still assessing damages and impacts. We are dispatching recovery teams to affected areas.”

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DEA Issues Warning About Illegal Online Pharmacies

https://www.dea.gov/alert/dea-issues-warning-about-illegal-online-pharmacies

October 4, 2024 – The U.S. Drug Enforcement Administration has seen an increase in illegal online pharmacies selling and shipping counterfeit pills made with fentanyl and methamphetamine to unsuspecting customers in the United States who believe they are purchasing real pharmaceutical drugs such as Oxycodone, Adderall, Xanax, and other drugs from legitimate pharmacies. 

As Americans increasingly turn to online pharmacies to purchase necessary medications[1], DEA is issuing this Public Safety Alert to warn of an increase in illegal online, often foreign-based websites that are deceptively targeting American consumers. DEA has identified websites being operated in India and the Dominican Republic. Many of these sites purport to be legitimate, U.S. based or FDA approved sites, but are actually working with drug traffickers to fulfill online orders with fake pills. These website operators are going to great lengths to make the websites look like legitimate online pharmacies – they offer 24-hour customer service, post online reviews and safety facts, and offer deep discounts to deceive customers into believing they were buying from a reputable business.

Often these illegal, online websites use U.S. website addresses and professional-looking designs to appear legitimate when, in fact, they are not. These companies operate illegally, deliberately deceiving American customers into believing they are purchasing safe, regulated medications when they are actually selling fake, counterfeit pills made with fentanyl or methamphetamine.  Fake medications can lead to serious health risks, including harmful side effects, ineffective treatment, and even death. 

During Operation Press Your Luck, announced on Monday, September 30, 2024, DEA discovered that a U.S. based victim had ordered what she believed to be oxycodone from an online pharmacy, only to receive a fake pill made with fentanyl. The pill looked identical to a real oxycodone, but it was not – it was made with fentanyl and filler. Days after receiving the medication, the victim passed away from acute fentanyl poisoning as a result of taking one of the pills sent to her.  

The DEA has identified the following fake pharmacies in a recent criminal investigation: 

• www.Curecog.com
• www.Pharmacystoresonline.com
• www.Careonlinestore.com
• www.yourphamacy.online 
• www.MD724.com
• www.Greenleafdispensarystore.com
• www.Whatishydrocodone.weebly.com
• www.Orderpainkillersonline.com
• www.USAMedstores.com

If you have purchased alleged medication from any of these websites, you should immediately stop using it and contact your local DEA office or report the incident here. 

The only safe prescription medications are those prescribed by a licensed medical provider and dispensed by a trusted pharmacy. 

Patients should remain vigilant when purchasing medications online. 

DEA remains committed to the safety and health of the American people, which is why we are urging consumers to exercise extreme caution when purchasing medications online. While it can be difficult to identify an illegal online pharmacy, the following are possible red flags that a website is not a legitimate:  

• Sells prescription drugs without requiring a valid prescription from a healthcare provider
• Offers much cheaper prices than what is typically seen in the market
• Lists prices in a foreign currency
• Does not contain proof of a valid pharmacy state license or DEA registration 
• Medicine arrives in broken or damaged packaging or in a foreign language
• Medicine does not have an expiration date or is expired 
• Medicine looks different from what you have received in the past from your trusted pharmacist

For more information on how to keep you and your loved ones safe from illegal and fake pills, visit DEA’s One Pill Can Kill resource page. Visit the U.S. Food and Drug Administration’s BeSafeRx campaign page for information on how to safely buy prescription medicines online and to locate a state-licensed online pharmacy. You can also contact your state board of pharmacy to verify a pharmacy’s license. 

DEA is committed to working jointly with the medical community to ensure legitimate controlled substances are not being diverted for illegal use. Learn more about DEA’s Diversion Control Division here. 

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How opioid prescriptions are tracked and monitored by law enforcement and health care providers

https://whyy.org/segments/how-opioid-prescriptions-are-tracked-and-monitored-by-law-enforcement-and-health-care-providers/

Medical sociologist Liz Chiarello discusses the effects of prescription drug monitoring programs on both patients and physicians.

Associate Professor of Sociology at Saint Louis University, Liz Chiarello, argues that new drug surveillance programs called Prescription Drug Monitoring Programs (PDMPs) blur the lines between law enforcement and health care. 

In her recently published book, “Policing Patients: Treatment and Surveillance on the Frontlines of the Opioid Crisis,” Chiarello discusses instances of patients being denied care and doctors being prosecuted for overprescribing pain medications. 

PDMPs were put in place as one solution in response to the growing number of opioid-related deaths in the United States. 

A PDMP is a database that tracks prescriptions of controlled substances, like morphine or oxycodone. These programs were made to document and flag doctors who overprescribe opioids to patients and identify patients who visit several doctors to obtain new prescriptions. Law enforcement agents, prosecutors, physicians, and pharmacists all have access to this database and medical information. This brings up questions about privacy, says Chiarello, and whether or not access to this information goes against the privacy rights of the individual or the patient. 

[The PDMP], “undermines the way that we usually think that medicine should work and the privacy protections that are associated with our health data,” says Chiarello.   

PDMPs do not only affect patients. They flag physicians too. 

“If doctors violate the stipulations under which they’re allowed to provide these controlled medications, then they’re extremely vulnerable because you go from being a doctor in the eyes of the law to being a drug dealer in the eyes of the law,” Chiarello says.  

Physicians can face arrest, prosecution, and even jail time if law enforcement notices a pattern of overprescribing opioids to their patients. 

So, what happens when a patient with suspicious opioid-use history goes to the pharmacy to request a new prescription? 

Chiarello says a pharmacist might say, “Well, I looked you up in the database and the database shows me that you just went to two different doctors in the last month. And so, this is too soon for me to dispense this to you.” 

Chiarello says this direct communication from the pharmacist, “says to the patient, I’m looking at you. And I have data about what you’ve been doing when you’re not at my pharmacy. But then it also tells them, you’re not really welcome back here. Like, don’t come back to me because I’m surveilling you.” 

The goal of these programs is to deter people from overusing opioids, and therefore lessen the impact of the opioid crisis. However, people who use opioids, larger amounts that might be flagged by a PDMP, are not all opioid abusers. For example, there are patients with chronic pain who have been living with a certain prescription that allows them to function normally in their daily lives. Without it, they would be living in constant pain. 

Chiarello dives deeper into the topic of PDMPs and how these programs impact patients with chronic pain and the future of drug prescription regulation in a conversation with Maiken Scott, host of The Pulse.

Interview Highlights: 

Doctors’ response to PDMPs

Doctors have had to figure out how to rework their practice to navigate a shifting legal territory. And so what a lot of doctors have done is they just refused to provide opioids. And they feel like that protects them, but it doesn’t necessarily protect their patients. So this is a space where the ethics of medicine and the care for the patient bump up against the fear of law enforcement.

… [Doctors] have patients sign pain contracts, which are these legalistic documents that say things like, I am your only doctor, you’re only going to see me, you are only going to go to this one pharmacy. I’m going to test your urine when I want to. You’re not going to go to the hospital asking for opioids, and if you do any of those things, if you violate the stipulations of our contract, you are no longer my patient. I will cut you off.

What happens to patients who rely on opioid prescriptions to get through the day just because their chronic pain is so terrible?

It’s really devastating what’s happened to those patients. The biggest driver is the CDC guidelines on using opioids to treat pain that came out in 2016 … and they make a lot of suggestions about what dosage patients should be on, when to initiate a dose. And it’s really supposed to be for people who are newly on opioids. But by the time those came out, there were people who had been on opioids for 20 years, who were in chronic pain, who are on very high doses of opioids. And there was a lot of pressure to taper those people down. The measurement is … called a morphine milligram equivalent, an MME. And the CDC guidelines say that people should be under 90. And a lot of people are on 300 or 350. And so a lot of doctors are concerned that that creates a red flag for them to law enforcement. And so they then try to cut those patients down often very quickly and without consent. So you have patients who had been well managed on opioids, who suddenly are not well managed. And, they’re thrust into pain. And then they can’t find another doctor who’s willing to prescribe for them. And so those patients, those patients are really suffering.

Could you see the PDMPs being used in any other way? Could you see their use being expanded?

I have made the argument that the PDMP is a law enforcement surveillance tool. And that, even if it’s in health care, it retains the vestiges of being a law enforcement surveillance tool … And so, we have to rethink whether we think prescription data is private data, or if we think it’s something else, the way that it’s being treated right now. 

But you also asked if I can see it expanding, and you know the saying… matter can be neither created nor destroyed. Well, technology is so easily created and very difficult to destroy. Because once you’ve created the technology, suddenly you realize there are all kinds of different uses for the technology. And so, one of the things that has changed with PDMPs is in a couple of states, they’ve started to put drug arrest data in the PDMP. So, they’re actually combining law enforcement data with health care data in the same system. 

But we can also certainly imagine a lot of other drugs being policed. I’m thinking about drugs used for reproductive health. I’m thinking about drugs used for gender affirming care. Once you have this kind of system, it’s very easy to add other drugs and to track other kinds of drugs. And so, I think they’ve only just barely dipped their toes into what kinds of medications they’re going to surveil.

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More Deception from Express Scripts!

https://pharmacistactivist.com/2024/September_2024.shtml

The lead commentary in the August issue of The Pharmacist Activist was, “Express Scripts Attempts to Change its Identity,” that responds to its full-page advertisement in major newspapers. The PBM has followed that with another full-page ad that continues the deception and lies, but provides no transparency regarding its operations, rebates from pharmaceutical companies, steering patients to its own pharmacies, and other “facts” which they accuse its critics of ignoring. The new ad begins with the following pronouncement in large type.

(Editor’s comment: A majority of the FTC Commissioners approved the report but Express Scripts prefers that the public knows the opinion of the one Commissioner who dissented).

(Editor’s comment: The large increase in drug prices during Express Scripts’ “watch” contradicts any claims of success in achieving affordability).

(Editor’s comment: Express Scripts can provide very specific data when it considers it to be in its own interest to do so. There are some references provided in very small type at the bottom of the advertisement. The two references provided as the source of the two statistics noted are attributed to Evernorth, the parent company of Express Scripts. There is no reason to think that this self-generated report is any more credible than the other claims made by Express Scripts).

(Editor’s comment: The most revealing word in this statement is “nearly.” Express Scripts is able to identify the specific percentage of rebates but refuses to do so. Does 90% qualify as “nearly?” 75%? 51%? The claims processed by the three major PBMs have a cost of billions of dollars. Even if they retain only a small percentage of the fees and rebates, the amount is huge. The rebate game is a self-enrichment contest that creates an incentive for higher drug prices and benefits only the PBMs and pharmaceutical companies. Everyone else loses – it is fraudulent and must be terminated).

(Editor’s comment: “Billions of data points” suggest that the PBMs were responsive to the FTC’s request for information. However, the FTC was delayed and frustrated in addressing concerns about PBMs because they did not respond in providing requested information on a timely basis and most likely are still withholding information needed for a complete analysis of its operations and monopolistic practices. The allegation by Express Scripts that the FTC used “convenient timing” in issuing its report is disingenuous. The FTC had announced its plan to sue Express Scripts and other PBMs. It is actually Express Scripts that is exercising “convenient timing” by suing the FTC as a preemptive action before the FTC filed its lawsuit. Express Scripts is taking a page out of Walmart’s playbook when, several years ago in anticipation of a lawsuit by the federal government for its role in opioid overdosage deaths, Walmart sued the federal government. Walmart’s lawsuit was dismissed and the one filed by Express Scripts should also be dismissed).

(Editor’s comment: PBMs receive larger rebates for the most expensive drugs. More expensive drugs are often placed in the more favorable tiers of their formularies, even when less expensive alternatives are available. Patients, employers, and taxpayers pay more. Pharmacists are also victims of the greed, fraud, and policies of the PBMs, and many pharmacies have closed because they can’t survive financially).

The Express Scripts suit against the FTC seeks to have the agency retract its report that is critical of the PBMs… To challenge the statements in the FTC report, Express Scripts primarily relies on the “research” of an economist who essentially concludes that the FTC’s claims about the PBMs “are not supported by the data.” The economist’s conclusions are strongly refuted in a comprehensive analysis by 46Brooklyn Research in its detailed report of September 20, “Express Scripts, Inc. vs. The Federal Trade Commission.” The CEO of 46Brooklyn Research is Antonio Ciaccia whose investigations exposed the PBM fraud in Ohio several years ago.

The FTC lawsuit

On September 20 the FTC sued the three largest PBMs. The title and subtitle of the FTC press release are noted below:

The FTC press release includes the following allegations:

Rahul Rao, the Deputy Director of the FTC’s Bureau of Competition, notes: “Caremark, ESI, and Optum–as medication gatekeepers–have extracted millions of dollars off the backs of patients who need life-saving medications. The FTC’s administrative action seeks to put an end to the Big Three’s exploitative conduct and marks an important step in fixing a broken system…”

For many years, pharmacists have been victimized by the deception and fraud of the PBMs, and have been very frustrated in not having our important concerns understood and/or effectively addressed by regulators, legislators, and federal agencies. Although there is much still to be accomplished, it is very encouraging that the FTC has investigated and understands the problems, and has taken action to sue the PBMs. The leaders and membership of the National Community Pharmacists Association (NCPA) are to be highly commended for providing numerous specific examples and other information that have exposed the egregious policies and terms of the PBM programs. The American Pharmacists Association (APhA) has also been very active in this regard, and both of the organizations, as well as others, are strongly supporting proposed federal legislation with bipartisan support to accomplish PBM reform. The time to accomplish this is short. Every pharmacist should contact their Senator and Representative to ask them (if it is not already known) if they are supporting the legislative proposals and urge them to support them. The specific legislative proposals are:

Others have also exposed the deceptive actions of the PBMs. Matt Stoller is the Director of Research at the American Economic Liberties Projects, and an expert on monopolies. He is the author of the book Goliath: The Hundred Year War Between Monopoly Power and Democracy, and also writes the Substack publication BIG. His commentary on September 23, “Monopoly Round-Up: Lina Khan, Pharma Middlemen and ‘Tasty Rebates,'” provides excellent coverage of the FTC suit. Using Lantus as an example, he notes that its list price in 2019 was $403 for a one-month supply. During 2019, its manufacturer (Sanofi) was giving OptumRx 80% of the list price to be the preferred insulin for its patients. “That’s just $64 going to Sanofi for the drug, and $339 going to OptumRx as a kickback.” In describing how PBMs work, he states:

“They aren’t just middlemen, they are allocators of what really looks perilously close to organized crime loot to a series of conspirators, from pharmaceutical firms to insurers to benefit consultants to large employers.”

Wall Street Journal editorial

The lead editorial in the September 26 issue of The Wall Street Journal is titled, “Higher Health Premiums for All,” and the subtitle is “Lina Khan piles on the anti-PBM bandwagon, to ill effect for consumers.” I responded with the following letter to the editor:

It is unlikely that my letter will be published, but I couldn’t be silent after reading it. If any readers can use any or all of the content of this letter in your communications with the media, legislators, or others, please feel free to do so in your own message. It is not necessary to identify me as the source.

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