Rx Opioid Sales Rose at Publix as Other Pharmacies Cut Back

By Ian Hodgson and Christopher O’Donnell, Tampa Bay Times  

An executive at Teva Pharmaceuticals flagged Publix Super Markets in October 2015 after detecting what he called in an email “serious red flags” with the grocery chain’s orders of powerful opioids.

The share of high-strength oxycodone orders was well above normal for a chain of grocery store pharmacies, and the total number of pills sent to Publix stores was “significantly above their peers,” Teva’s head of federal compliance wrote in the email to his supervisors, according to court records in a federal lawsuit pending in Ohio against Publix and other companies.

“This is high-strength oxycodone ultimately going to Florida, a well-established hot spot for oxycodone abuse in the U.S.,” wrote the compliance officer, Joseph Tomkiewicz, in the email explaining why he halted Teva-manufactured prescription opioids to Florida’s Publix pharmacies.

The volume of prescription opioids dispensed in Florida fell 56% from 2011 to 2019 as the pharmaceutical industry was hit by lawsuits for its role in the national opioid crisis, according to a Tampa Bay Times analysis of Drug Enforcement Administration data recently released by a federal court. But while national pharmacy chains like CVS and Walgreens were dispensing fewer of the highly addictive drugs, Publix’s sales were soaring.

The Lakeland-based grocer’s sales of oxycodone climbed from 26 million pills per year in 2011 to 43.5 million in 2019, the data shows. The increase in sales, which far outpaced the chain’s addition of stores in Florida, saw its market share rise to 14%, enough to overtake CVS to become Florida's second-largest dispenser of all opioid medications, behind only Walgreens, which dispensed 28% of opioids in the state in 2019. The analysis excludes drugs like methadone prescribed for addiction treatment. Opioid sales at Publix dipped slightly in 2018 and 2019, the last two years of available data.

Even as its market share grew, however, Publix was not among the 15 national manufacturers, distributors, and pharmacies that Florida sued in 2018. That lawsuit claimed other pharmacies had flooded America with painkillers such as OxyContin, fueling debilitating addictions that strained communities’ first responders and medical providers.

The state’s lawsuit was a boon for Florida. While admitting to no wrongdoing, the companies agreed to settlement payments to the state, including $177 million from Teva, $440 million from CVS, and $620 million from Walgreens. The state didn’t sue Walmart but in 2022 negotiated a $215 million settlement from the retail giant, which also denied any wrongdoing.

However, there is no mention of Publix’s role on a state webpage touting the 10 opioid settlements reached during Ashley Moody’s tenure as attorney general.

That’s despite Publix being the third-biggest dispenser of opioids in the state, selling nearly twice the amount of the drugs as Walmart from 2006 to 2012, according to earlier DEA data made public in July 2019, more than two years before Florida prosecutors reached settlements with other pharmacy chains.

Moody, a Republican, took over as the state’s top legal official in January 2019. Her office declined to specifically address why Florida has not included Publix in any of its legal actions over opioids.

“We are proud of the more than $3 billion recovered through the historic opioid litigation, and since the filing of the amended complaint, the Department of Legal Affairs has and will continue to take action when merited by the evidence — as we did in the more recent actions with Walmart and McKinsey,” said Moody’s communications director, Kylie Mason, in an email.

The grocery chain made $10.6 million in political donations in Florida from 2016 to 2022 when the state was preparing and pursuing its litigation, state election data shows. Most of the donations were for Republican committees and candidates, including $125,000 donated to the Friends of Ashley Moody political action committee.

In Florida, Walgreens made $637,000 in political donations, including $8,000 to Moody, over the same period. CVS made $208,500 in donations, none of which went to Moody.

Other local communities in Florida and beyond did sue Publix. The federal suit naming Publix that prompted the release of the federal data was filed by Georgia's Cobb County. It has been earmarked as a test case for dozens of other lawsuits brought by cities and counties in the Southeast. Those include more than 20 Florida communities, among them St. Petersburg and Pinellas and Pasco counties.

While Walgreens and other national companies paid billions to settle their lawsuits and agreed to stricter drug controls, Publix is still contesting the cases.

Those communities claim that the grocery chain failed to operate an “effective suspicious ordering monitoring program” and that when Publix did limit orders to its own pharmacies, those pharmacies could bypass the check by going to a third-party distributor such as AmerisourceBergen.

Publix also should have known that its pharmacies in Georgia, Florida, Alabama, Tennessee, and South Carolina, were filling multiple prescriptions written for the same patient by the same doctor or by multiple doctors, the federal lawsuit alleges. As part of the national opioid settlement, other pharmacy chains were required to be more compliant with laws regulating opioids, including checks on suspicious orders and prescriptions from “blocked and potentially problematic” doctors.

“It’s a heck of a lot cheaper to distribute and dispense controlled substances without all these checks,” said Jayne Conroy, an attorney with New York law firm Simmons Hanly Conroy who is representing the Florida communities and has served as co-lead counsel in the national opioid litigation that has secured more than $50 billion in settlements and verdicts.

Publix did not respond to three emails and three phone calls to its communications office seeking comment. In its responses to the lawsuits, it has repeatedly denied allegations of wrongdoing.

In seeking to get the Ohio case dismissed, Publix attorneys argued that it can’t be considered “a public nuisance” to legally distribute and dispense opioids. The judge in the case denied the company’s motion and another legal brief that sought to prevent the release of the more recent DEA data.

In November 2022, Publix sued more than a dozen of its insurers in federal court in Tampa, claiming they had not honored policies that would protect it from opioid litigation claims.

It also countersued Cobb County in 2023, saying the Georgia community’s lawsuit was “motivated by promises of a windfall.” The case is still pending.

“Publix takes great pride in its relationship with its valued customers and the communities it serves,” that lawsuit states. “These novel and unprecedented claims are baseless, false, and belied by Publix’s decades of service.”

DEA officials declined to comment on Publix’s opioid record. No enforcement actions against Publix are listed in the federal registry.

A Growing Player

Since its 1930 start as a food store in Winter Haven, Florida, Publix has grown into a massive company with more than 250,000 employees and nearly 900 stores in Florida alone. Revered for its free cookies for kids, chicken tender subs, fresh produce, birthday cakes, and BOGO deals, the grocery chain has become one-stop shopping for customers.

And, increasingly, “Where Shopping Is a Pleasure” — Publix’s slogan since 1954 — includes powerful prescription drugs.

Publix was a smaller player in Florida’s opioid market before 2011, responsible for fewer than 5% of all opioid medications distributed to pharmacies across the state, according to the Times analysis of federal opioid data.

That year marked a turning point for opioid sales in Florida. As the scale of the opioid epidemic came to public attention, and litigation followed, most chain pharmacies began to back off their orders for pills, the data shows.

Many companies ultimately agreed to pay billions of dollars to settle lawsuits filed across the country by state and local governments. That included a $683 million settlement between Florida and Walgreens in May stating the pharmacy, which denied any wrongdoing, must pay for community treatment, education, and prevention programs, plus litigation costs.

In addition to hefty payouts, some settlement agreements required companies to adopt stricter controls to bring operations into fuller compliance with the Controlled Substances Act, a federal law that governs the manufacture, distribution, and use of drugs considered to have a high risk of being abused.

Distributors were required to adopt automated software that would flag suspicious orders from pharmacies such as quantities well above a store’s average. Pharmacy companies were required to conduct checks on doctors to ensure the prescribers are registered with the Drug Enforcement Administration. 

Those measures and others put the brakes on opioid distribution nationwide. Meanwhile, the distribution in Florida’s Publix stores went in the opposite direction: From 2011 to 2019, the grocery chain increased its dispensing of all opioid medication by 35%, according to the Times’ analysis of the data.

That growth far exceeded any increase in sales that would correspond to the grocer’s net addition of 146 pharmacies from 2011 to 2019.

As Publix’s distribution increased, so too did the number of orders that should have been flagged as suspicious, according to plaintiffs in multiple lawsuits. Drug distributor McKesson instructed its employees to investigate any pharmacy ordering more than 8,000 oxycodone pills in a single month as part of the company’s “Lifestyle Drug Monitoring Program,” according to 2018 congressional testimony.

Publix pharmacies’ orders surpassed that threshold almost 1,500 times in 2019, the Times analysis found, more than triple the number in 2011. The benchmark has been repeatedly used in opioid litigation as evidence of inadequate monitoring of drug distribution.

‘Red Flags’ Missed

As Tomkiewicz faced pressure from Teva management to fulfill Publix’s orders, he mined the data to back up his concerns, court records show. During a heated phone call, one Teva executive stressed that Publix was an increasingly important player in the opioid distribution market, Tomkiewicz said at his deposition, and an important client for the world’s largest generic drug manufacturer.

Tomkiewicz requested data from Publix’s 10 largest pharmacies by opioid sales, all located in Florida.

By law, Publix was required to keep tabs on the physicians whose prescriptions it filled. But it took Tomkiewicz just one day of searching the internet to find problems, according to time stamps on emails submitted in the court records.

Among the top prescribers at two Publix locations in Melbourne was Thomas Velleff, according to Tomkiewicz’s email. Public records and a newspaper report showed “significant anecdotal evidence of pill mill activity,” Tomkiewicz wrote. He said he found a 2010 article in the Treasure Coast Palm, in which a city employee claimed Velleff’s prior pain clinic in Palm City attracted “carloads” of patients, often with out-of-state license plates.

Complaints filed with the state Department of Health dating to 2010 allege that Velleff overprescribed opioids and failed to monitor his patients’ usage for signs of abuse. One 2017 complaint alleges that Velleff pressured one patient into loaning him money. The state Board of Medicine revoked Velleff’s medical license in December 2020. Velleff did not appear at his medical board hearing, according to the final order revoking his license. He did not respond to emails seeking comment.

A top prescriber at one Ocala store had been disciplined in 2011 for injecting herself with a sedative while leaving an anesthetized patient unsupervised. Other pharmacies repeatedly filled prescriptions from “cash-only” pain clinics or written by physicians located hundreds of miles away with no license to practice in Florida, Tomkiewicz wrote in the email. It is legal to do so, but drug diversion experts consider out-of-state prescriptions a red flag that should prompt additional checks for possible drug abuse.

Tomkiewicz had amassed a list of nine doctors among Publix’s top prescribers who made him wonder: “Why the hell do they still have a license and are still registered with the DEA?” according to his deposition.

Tomkiewicz also said in his deposition he was troubled by not just the volume of opioids Publix was selling, but that they were handing out a disproportionate share of 30-milligram instant-release oxycodone pills — another red flag for abuse. In an email to Teva’s director of compliance, he compared that with the Moffitt Cancer Center in Tampa, where cancer patients were mostly being prescribed 5 mg instant-release pills, court records show.

As the strongest dose on the market, the 30 mg pills have limited use in retail pharmacies and are highly sought-after among abusers, Tomkiewicz wrote in the email. Stronger doses of oxycodone are available, but only in long-release capsules such as OxyContin, according to the U.S. National Institutes of Health.

Publix sold 4.8 million of the highly addictive high-dose pills in 2019 — roughly 1 in 10 of all oxycodone pills dispensed by the pharmacy chain that year, according to the Times analysis of the federal data.

Eventually, Tomkiewicz relented, he said in his deposition. As long as Publix promised not to send Teva products to nine locations that he’d picked out, he would let the shipment go ahead. Teva did not notify federal authorities, according to his deposition.

A Times review of court documents found no written record indicating that Publix responded to Tomkiewicz’s concerns at the time. An expert report submitted in the lawsuit came to the same conclusion.

This article was produced by the Tampa Bay Times and KFF Health News, a national newsroom that produces in-depth journalism about health issues.

Drugmakers Are Abandoning Cheap Generics

By Arthur Allen, KFF Health News

On Nov. 22, three FDA inspectors arrived at the sprawling Intas Pharmaceuticals plant south of Ahmedabad, India, and found hundreds of trash bags full of shredded documents tossed into a garbage truck.

Over the next 10 days, the inspectors assessed what looked like a systematic effort to conceal quality problems at the plant, which provided more than half of the U.S. supply of generic cisplatin and carboplatin, two cheap drugs used to treat as many as 500,000 new cancer cases every year.

Seven months later, doctors and their patients are facing the unimaginable: In California, Virginia, and everywhere in between, they are being forced into grim contemplation of untested rationing plans for breast, cervical, bladder, ovarian, lung, testicular, and other cancers. Their decisions are likely to result in preventable deaths.

Cisplatin and carboplatin are among scores of drugs in shortage, including 12 other cancer drugs, attention-deficit/hyperactivity disorder pills, blood thinners, antibiotics and opioids. Covid-hangover supply chain issues and limited FDA oversight are part of the problem, but the main cause, experts agree, is the underlying weakness of the generic drug industry.

Made mostly overseas, these old but crucial drugs are often sold at a loss or for little profit. Domestic manufacturers have little interest in making them, setting their sights instead on high-priced drugs with plump profit margins.

The problem isn’t new, and that’s particularly infuriating to many clinicians. President Joe Biden, whose son Beau died of an aggressive brain cancer, has focused his Cancer Moonshot on discovering cures — undoubtedly expensive ones. Indeed, existing brand-name cancer drugs often cost tens of thousands of dollars a year.

But what about the thousands of patients today who can’t get a drug like cisplatin, approved by the FDA in 1978 and costing as little as $6 a dose?

“It’s just insane,” said Mark Ratain, a cancer doctor and pharmacologist at the University of Chicago. “Your roof is caving in, but you want to build a basketball court in the backyard because your wife is pregnant with twin boys and you want them to be NBA stars when they grow up?”

“It’s just a travesty that this is the level of health care in the United States of America right now,” said Stephen Divers, an oncologist in Hot Springs, Arkansas, who in recent weeks has had to delay or change treatment for numerous bladder, breast, and ovarian cancer patients because his clinic cannot find enough cisplatin and carboplatin.

Results from a survey of academic cancer centers released June 7 found 93% couldn’t find enough carboplatin and 70% had cisplatin shortages.

“All day, in between patients, we hold staff meetings trying to figure this out,” said Bonny Moore, an oncologist in Fredericksburg, Virginia. “It’s the most nauseous I’ve ever felt. Our office stayed open during covid; we never had to stop treating patients. We got them vaccinated, kept them safe, and now I can’t get them a $10 drug.”

The 10 cancer clinicians KFF Health News interviewed for this story said that, given current shortages, they prioritize patients who can be cured over later-stage patients, in whom the drugs generally can only slow the disease, and for whom alternatives — though sometimes less effective and often with more side effects — are available. But some doctors are even rationing doses intended to cure.

Isabella McDonald, then a junior at Utah Valley University, was diagnosed in April with a rare, often fatal bone cancer, whose sole treatment for young adults includes the drug methotrexate. When Isabella’s second cycle of treatment began June 5, clinicians advised that she would be getting less than the full dose because of a methotrexate shortage, said her father, Brent.

“They don’t think it will have a negative impact on her treatment, but as far as I am aware, there isn’t any scientific basis to make that conclusion,” he said. “As you can imagine, when they gave us such low odds of her beating this cancer, it feels like we want to give it everything we can and not something short of the standard.”

Brent McDonald stressed that he didn’t blame the staffers at Intermountain Health who take care of Isabella. The family — his other daughter, Cate, made a TikTok video about her sister’s plight — were simply stunned at such a basic flaw in the health care system.

At Moore’s practice, in Virginia, clinicians gave 60% of the optimal dose of carboplatin to some uterine cancer patients during the week of May 16, then shifted to 80% after a small shipment came in the following week. The doctors had to omit carboplatin from normal combination treatments for patients with recurrent disease, she said.

ISABELLA MCDONALD AND HER FATHER, BRENT

On June 2, Moore and her colleagues were glued to their drug distributor’s website, anxious as teenagers waiting for Taylor Swift tickets to go on sale — only with mortal consequences at stake.

She later emailed KFF Health News: “Carboplatin did NOT come back in stock today. Neither did cisplatin.”

Doses remained at 80%, she said. Things hadn’t changed 10 days later.

Generics Manufacturers Are Pulling Out

The causes of shortages are well established. Everyone wants to pay less, and the middlemen who procure and distribute generics keep driving down wholesale prices. The average net price of generic drugs fell by more than half between 2016 and 2022, according to research by Anthony Sardella, a business professor at Washington University in St. Louis.

As generics manufacturers compete to win sales contracts with the big buyers, including wholesale purchasers Vizient and Premier, their profits sink. Some are going out of business. Akorn, which made 75 common generics, went bankrupt and closed in February.

Israeli generics giant Teva, which has a portfolio of 3,600 medicines, announced May 18 it was shifting to brand-name drugs and “high-value generics.” Teva notified the FDA earlier that month that it was discontinuing production of oxycodone tablets, a move that could exacerbate shortages of opioid pain medication.   

Lannett Co., with about 120 generics, announced a Chapter 11 reorganization amid declining revenue. Other companies are in trouble too, said David Gaugh, interim CEO of the Association for Accessible Medicines, the leading generics trade group.

The generics industry used to lose money on about a third of the drugs it produced, but now it’s more like half, Gaugh said. So when a company stops making a drug, others do not necessarily step up, he said.

Officials at Fresenius Kabi and Pfizer said they have increased their carboplatin production since March, but not enough to end the shortage. On June 2, FDA Commissioner Robert Califf announced the agency had given emergency authorization for Chinese-made cisplatin to enter the U.S. market, but the impact of the move wasn’t immediately clear.

Cisplatin and carboplatin are made in special production lines under sterile conditions, and expanding or changing the lines requires FDA approval. Bargain-basement prices have pushed production overseas, where it’s harder for the FDA to track quality standards. The Intas plant inspection was a relative rarity in India, where the FDA in 2022 reportedly inspected only 3% of sites that make drugs for the U.S. market.

Sardella, the Washington University professor, testified last month that a quarter of all U.S. drug prescriptions are filled by companies that received FDA warning letters in the past 26 months. And pharmaceutical industry product recalls are at their highest level in 18 years, reflecting fragile supply conditions. The FDA listed 137 drugs in shortage as of June 13, including many essential medicines made by few companies.

Intas voluntarily shut down its Ahmedabad plant after the FDA inspection, and the agency posted its shocking inspection report in January. Accord Healthcare, the U.S. subsidiary of Intas, said in mid-June it had no date for restarting production.

Asked why it waited two months after its inspection to announce the cisplatin shortage, given that Intas supplied more than half the U.S. market for the drug, the FDA said via email that it doesn’t list a drug in shortage until it has “confirmed that overall market demand is not being met.”

Prices for carboplatin, cisplatin, and other drugs have skyrocketed on the so-called gray market, where speculators sell medicines they snapped up in anticipation of shortages. A 600-milligram bottle of carboplatin, normally available for $30, was going for $185 in early May and $345 a week later, said Richard Scanlon, the pharmacist at Moore’s clinic.

“It’s hard to have these conversations with patients — ‘I have your dose for this cycle, but not sure about next cycle,’” said Mark Einstein, chair of the Department of Obstetrics, Gynecology and Reproductive Health at Rutgers New Jersey Medical School.

Should Government Step In?

Despite a drug shortage task force and numerous congressional hearings, progress has been slow at best. The 2020 CARES Act gave the FDA the power to require companies to have contingency plans enabling them to respond to shortages, but the agency has not yet implemented guidance to enforce the provisions.

As a result, neither Accord nor other cisplatin makers had a response plan in place when Intas’ plant was shut down, said Soumi Saha, senior vice president of government affairs for Premier, which arranges wholesale drug purchases for more than 4,400 hospitals and health systems.

Premier understood in December that the shutdown endangered the U.S. supply of cisplatin and carboplatin, but it also didn’t issue an immediate alarm, she said. “It’s a fine balance,” she said. “You don’t want to create panic-buying or hoarding.”

More lasting solutions are under discussion. Sardella and others have proposed government subsidies to get U.S. generics plants running full time. Their capacity is now half-idle. If federal agencies like the Centers for Medicare & Medicaid Services paid more for more safely and efficiently produced drugs, it would promote a more stable supply chain, he said.

“At a certain point the system needs to recognize there’s a high cost to low-cost drugs,” said Allan Coukell, senior vice president for public policy at Civica Rx, a nonprofit funded by health systems, foundations, and the federal government that provides about 80 drugs to hospitals in its network. Civica is building a $140 million factory near Petersburg, Virginia, that will produce dozens more, Coukell said.

Ratain and his University of Chicago colleague Satyajit Kosuri recently called for the creation of a strategic inventory buffer for generic medications, something like the Strategic Petroleum Reserve, set up in 1975 in response to the OPEC oil crisis.

In fact, Ratain reckons, selling a quarter-million barrels of oil would probably generate enough cash to make and store two years’ worth of carboplatin and cisplatin.

“It would almost literally be a drop in the bucket.”

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

Why Changes at Teva Could Worsen Rx Opioid Shortages

By Pat Anson, PNN Editor

A change in the business model of one of the world’s largest manufacturers of generic drugs could lead to further shortages of opioids and other medications in the United States, according to an industry expert.

Last week Israel-based Teva Pharmaceutical Industries said it would reduce its production of generics from 80% of its drug portfolio to 60% over the next few years. Teva’s CEO says the company plans to focus on more profitable branded drugs as part of its “pivot to growth.”

“The drugs we’re pulling out of are drugs which are low-margin,” CEO Richard Francis told Bloomberg.

Teva has not publicly identified which generic drugs it will stop producing, but said it would “very carefully” avoid dropping any medications that are already in short supply.

“We don’t want to let the pharmacists, the wholesalers and the patients down. We want to make sure they always have their drug when they’re looking for it,” Francis said in an interview with Endpoints News.

But Teva has already moved to reduce its production of generic oxycodone, informing the Food and Drug Administration earlier this month that it would discontinue producing 30, 15, and 5 mg tablets of immediate release oxycodone. Teva did not respond to multiple requests from PNN to explain the reasons for the discontinuation.

The FDA does not currently list oxycodone on its drug shortage database, but the American Society of Health-System Pharmacists (ASHP) does.

As PNN reported, ASHP added oxycodone to its nationwide list of drug shortages in March, with generic drug makers Amneal, Camber and Rhodes Pharmaceuticals reporting shortages of 5, 15, 20 and 30 mg oxycodone tablets.

“They are a large producer and other companies may not be able to make up the difference. I think it really will result in shortages.”

— Dr. Erin Fox, University of Utah Health

“I know that (Teva’s) CEO came out with a statement saying that they wouldn't leave the market for products that are in short supply, but it hasn't exactly been a great market overall. The overall capacity of just the generic market is very difficult. When you look at controlled substances, that gets even more difficult,” says Erin Fox, PharmD, Senior Pharmacy Director at University of Utah Health, which tracks drug shortages for the ASHP.

“They (Teva) are a large producer and other companies may not be able to make up the difference. I think it really will result in shortages.”

As an example of how tight the supply of opioids and other controlled substances is, Fox says the University of Utah Health system reached out to its drug wholesaler to let them know that it was adding 50 new beds to its cancer clinic and would be needing more pain medication and other drugs to treat the extra patients. The answer it received was not reassuring.

“It's mostly opioids that we anticipate needing more of. And the wholesaler said, ‘Well, let's just wait until we start receiving your orders to increase the amounts that you're going to buy,’” Fox told PNN. “I think the wholesalers’ settlement that they've done has really limited the amount of products that pharmacies can access. Even if you have the patients, it can be very difficult to increase the amount that you're ordering.”

Fox is referring to a $21 billion opioid litigation settlement that three large drug distributors reached with 46 states last year, which requires them to impose strict limits on the amount of opioids and other controlled substances they can supply to pharmacies in any given month. An unusually large order for opioids could result in a pharmacy getting red-flagged by a distributor and the order cancelled, regardless of patient needs.

“We're unable to be proactive. We're trying to think ahead. And we don't want to have that situation where we we're getting very close to running out or not having enough. That's basically what our wholesaler says has to happen,” Fox explained.

DEA Production Cuts

Fox says years of cuts in production quotas by the Drug Enforcement Administration have also contributed to shortages. With opioids and some other controlled substances in tight supply, there is little margin for error or unexpected developments in the pharmaceutical industry – like Teva reducing its production of generics.

Keeping track of the drug supply is made more difficult because production quotas for each company are not disclosed by the DEA and there is little transparency in the business.

“What we don't have is the amount that the DEA is giving to each supplier. And then we also don't know the amount that each supplier is then manufacturing. Because we don't have that transparency, it's really hard to know,” Fox said. “Drug manufacturing is a business. And even though patients are at the end of it, these drug companies don't have to tell people why they're discontinuing something. They don't have to have to say what market share they had or if they think there might be a shortage. They can just stop at any time.”

Another issue is that DEA’s annual production quotas are not transferable from one company to another. That’s why Fox believes the changes at Teva are likely to worsen drug shortages.

“DEA assumes that everything is going perfectly with manufacturing, that no companies are having a glitch, and no companies are having a problem. And so one company might be having manufacturing problems, but still holding onto their quota. They can't necessarily give it to another company who's able to ramp up production,” she said.

“There’s just a lack of transparency. It's very hard. I've been monitoring drug shortages for over 20 years. Almost always, when a company quits, we end up with some kind of a shortage. Hopefully it won't be long term.”

Another factor that could be influencing Teva’s decision is the $4.25 billion nationwide settlement the company agreed to pay in opioid litigation last year. Teva’s production of generic and branded opioids dwarfed that of Purdue Pharma and other better known drug companies. Now heavily in debt, Teva may have decided that profits in a low-margin product like opioids are simply not worth the risk.      

Positive Results for New Osteoarthritis Drug

By Pat Anson, Editor

Two pharmaceutical companies have announced positive results from a Phase 3 study of an experimental non-opioid pain reliever that has a history of safety concerns.

Teva and Regeneron are jointly developing fasinumab as a treatment for chronic pain from osteoarthritis of the knee and hip. The companies say patients treated for 16 weeks with fasinumab injections had significantly less pain and improved function compared to a placebo.

"We are encouraged by these data and look forward to advancing our pivotal Phase 3 fasinumab program in patients with osteoarthritis of the knee or hip, who currently have very limited therapeutic choices to treat their chronic pain, other than with non-steriodal anti-inflammatory drugs or opioids," said George Yancopoulos, MD, President and Chief Scientific Officer of Regeneron.

Fasinumab is a humanized antibody that targets nerve growth factor (NGF), a protein that increases in the body because of injury, inflammation or chronic pain. Fasinumab binds to NGF and inhibits pain signals from muscles, skin and organs from reaching the brain.

Teva and Regeneron say fasinumab was “generally well tolerated” in the Phase 3 study, with similar adverse events (AEs) as in previous trials. Treatment was discontinued due to AEs in 6 percent of the fasinumab patients, about the same as the placebo group. The companies plan to present further details at an upcoming medical conference.

Regeneron recently halted high-dose trials of fasinumab because the risk of harm outweighed the benefits of the drug. There is some concern that NGF antibodies work too well and encourage osteoarthritis patients to become more active, which accelerates joint deterioration. No cases of joint damage were observed in the current study.

Regeneron and Teva are currently enrolling osteoarthritis patients in three additional Phase 3 clinical trials, including one assessing the long-term safety of fasinumab and two trials comparing fasinumab to standard pain therapies.

There is intense competition about drug companies to develop non-opioid pain relievers that don’t have the risk of addiction and overdose. Pfizer and Eli Lilly are jointly developing a similar NGF inhibitor called tanezumab, which was given fast track designation by the FDA in 2017 to speed its development.

Like fasinumab, there are safety concerns about tanezumab. The FDA ordered a partial halt to clinical studies of tanezumab in 2010 after Pfizer said a small number of osteoarthritis patients taking the drug needed joint replacements. Another safety issue arose in 2012 because the drug caused “adverse changes in the sympathetic nervous system of mature animals.”  Most clinical studies of tanezumab did not resume until 2015.

New Treatments Offer Hope to Migraine Sufferers

By Pat Anson, Editor

Findings from several new clinical studies could pave the way for new treatments that could someday prevent and lessen the severity of migraines.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. Although there are many treatment options available, most migraine sufferers are not fully satisfied with their effectiveness.

Teva Pharmaceuticals (NYSE: TEVA) is developing a new injectable drug – called TEV-48125 – that is designed to be injected monthly in chronic migraine sufferers who have headaches at least 15 days per month.

"Chronic migraine affects about 1 percent of all adults, yet less than 5 percent of those people receive a correct diagnosis and appropriate treatment," said study author Marcelo Bigal, MD, of Teva Pharmaceuticals. "Most people who receive preventive medication for chronic migraine stop using them, and one reason for that is the drugs can take a long time to become effective.”

In findings published online in the journal Neurology, Bigal reported that TEV-48125 was effective in reducing the length of headaches three to seven days after the first injection. The drug contains an antibody that blocks the calcitonin gene-related peptide that plays a role in migraine pain.

Teva’s Phase II study involved 261 people with chronic migraine who were divided into three groups; one group received a monthly shot for three months with a low dose of TEV-48125, the second group received a high dose and the third group received a placebo shot. Participants then used an electronic diary to record the number and length of their headaches.

After one week, the average number of headache hours went down by 2.9 hours for people taking the placebo, 9.1 hours for people taking the low dose of TEV-48125 and 11.4 hours for those taking the high dose.

After two weeks, the number of days with moderate or severe headaches, fell by 0.8 days for patients getting the placebo, 1.3 days for the low dose and 1.5 days for the high dose of TEV-48125.

“If these results can be confirmed with larger studies, this could be exciting for people with migraine," said Bigal.

Amgen Injectable Migraine Drug

Amgen (NASDAQ: AMGN) and Novaratis (NYSE: NVS) are also developing a monthly injectable drug --- called erenumab – which contains an antibody that blocks a peptide receptor that is believed to transmit migraine pain signals.

In a Phase II study, 667 chronic migraine patients were injected with a placebo or two different doses (70 mg or 140 mg) of erenumab. At the start of the study, patients were experiencing about 18 migraine days per month.

Patients who received erenumab at either dose experienced an average 6.6-day reduction in migraine days, compared to a 4.2-day reduction in those who receive a placebo. Less than five percent of the  patients treated with erenumab had a side effect, such as injection site pain, upper respiratory tract infection and nausea.

Erenumab is currently under evaluation in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention. Amgen expects results from a Phase III study of erenumab in the second half of 2016. Depending on the findings, that could result in an early new drug application to the Food and Drug Administration.  

Clinical studies presented this week at the annual meeting of the American Headache Society also highlighted some promising new migraine treatments.

Alder BioPharmaceuticals presented data showing that a single injection of a drug called ALD403 reduces migraine for up to six months. In a recent Phase II study of patients with chronic migraine, ALD403 significantly reduced migraines by 75 percent in up to a third of patients. 

“A 75 percent reduction in migraine days for these patients means a reduction of 12 or more migraine days each month,” said Jeffrey T.L. Smith, MD, Senior Vice President at Alder. “This equates to giving patients back roughly two weeks of their lives after a single administration.”

Researchers at Montefiore Medical Center and Albert Einstein College of Medicine reported results from a placebo controlled study on the efficacy of ubrogepant in treating a single migraine attack. Patients who received ubrogepant reported a reduction in headache severity from severe or moderate to mild or none within two hours.

Ubrogepant is free of known cardiovascular risk and may provide an important treatment option for patients who suffer from cardiovascular disease. 

Migraine affect three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.