US doctors forced to ration as cancer drug shortages hit nationwide

Toni Dezomits during chemotherapy

Toni Dezomits during chemotherapy

Toni Dezomits had to change her ovarian cancer treatment plan due to a shortage of chemotherapy drugs

Toni Dezomits, a 55-year-old retired law enforcement officer, is battling a recurrence of her stage 4 ovarian cancer. She had already undergone several rounds of chemotherapy when her doctor told her he had more bad news.

Just a day before her third round of treatment last month, Ms. Dezomits was told there was a nationwide shortage of the generic chemotherapy drug, carboplatin, one of three drugs she was due to receive.

Forced to choose between giving up the drug or replacing it with one with stronger side effects, the North Carolina native is finishing her last three chemotherapy sessions on just two of the recommended drugs.

“You have these two suboptimal choices,” he said. “I’m concerned, because I know the drug I’m not taking is one that my cancer has responded to very well [the first time].”

Experts say the United States is currently suffering from one of the most severe shortages of chemotherapy drugs to have occurred in three decades.

Ms Dezomits is one of about 100,000 patients who may have been affected in recent months, according to Dr. Julie Gralow, chief medical officer at the American Society of Clinical Oncology.

As of this week, the US Food and Drug Administration (FDA) said more than 130 drugs are in short supply, 14 of which are cancer treatments.

Experts say a myriad of factors contributed to the shortage, which this time hit two front-line therapies – carboplatin and cisplatin – used to treat a range of cancers, including head and neck, gynecological and gastrointestinal cancers.

The most recent shortage occurred after the closure of a plant in India, which was supplying cisplatin materials to all US manufacturers, due to quality issues. This has increased demand for a replacement drug, carboplatin, Dr. Gralow said.

As a result, some providers have been forced to extend the time between patients’ chemotherapy sessions, while some patients have had to drive for several hours to receive treatment at different cancer centers.

When her local oncologist couldn’t provide her with carboplatin, Ms. Dezomits tried a larger cancer center in Texas, where she had been before. But she was told they couldn’t give her the drug because they were giving priority to patients more likely to be treated.

“It’s like battlefield triage,” said Ms. Dezomits, who was a soldier in the Persian Gulf War. “This country should be a little better than that. We should be able to get life-saving drugs that cost about $9 or $10 a dose.”

Carboplatin chemotherapy drug

The chemotherapy drugs carboplatin and cisplatin were hit hardest by the shortage

The low cost of generic first-line cancer drugs has actually played a role in the recurring shortage of chemotherapy drugs, experts say. While the drugs are cheap to make, drug companies have no incentive to do so because they don’t bring in large profits, said Dr. Karen Knudsen, CEO of the American Cancer Society.

The problem of drug shortages has also worsened as life expectancy in the United States has increased, which means that more and more people are getting cancer.

To help ease supply chain crises, the FDA this week began working with a Chinese manufacturer to import one of the chemotherapy drugs.

The move will likely help resolve some short-term supply constraints in the coming months, but will do little to address a more cyclical problem of chemotherapy drug shortages, said Dr. Knudsen.

“An emergency solution is being implemented, but we are at a time where a more lasting solution is needed,” he said.

Medical experts have said the US government should work with the private sector to find more long-term solutions.

The US government could use its drug purchase dollars to create national strategic stockpiles of critical drugs and incentivize higher-quality pharmaceutical companies to produce them, Dr. Gralow said.

The patient, Ms. Dezomits, fears that without further action, people in the United States could continue to find themselves in difficult situations to find the cancer treatment they need.

“It’s stressful enough dealing with cancer and your own mortality,” she said. “This is just another hurdle ahead of patients who now have to think about.”

#doctors #forced #ration #cancer #drug #shortages #hit #nationwide

Obesity Drug Stocks: Time to Buy Manufacturers of Ozempic, Mounjaro, Others?

Obesity Drug Stocks: Time to Buy Manufacturers of Ozempic, Mounjaro, Others?

The demand for drug therapies for obesity is on the rise. New drugs with efficacy rivaling bariatric surgery, with only minor tolerability issues, have replaced older drugs burdened with significant cardiovascular side effects and mediocre efficacy. The approval of Novo Nordisks’ NVO GLP-1 agonist Wegovy in 2021 led to increased demand for the active ingredient semaglutide in various forms, including the diabetes drug Ozempic. Mounjaro, the Eli Lillys LLY-approved diabetes drug, is poised to generate even stronger weight-loss results and will launch as an obesity treatment around the end of 2023. We think Novo and Lilly will continue to lead the market of obesity over the next 10 years, with incremental innovation in this rapidly expanding market that will underpin their broad economic moats. We expect new therapies launched in 2026 and beyond by companies like Amgen AMGN and Pfizer PFE to grow to about a quarter of the market by 2032.

The author or authors do not own shares in any of the securities mentioned in this article.

Learn about Morningstars editorial policies.

#Obesity #Drug #Stocks #Time #Buy #Manufacturers #Ozempic #Mounjaro

Evidence shows the immunotherapy drug Opdivo is safe and effective against Hodgkin’s lymphoma

Evidence shows the immunotherapy drug Opdivo is safe and effective against Hodgkin's lymphoma



Nivolumab outperformed the drug brentuximab vedotin (Adcetris), extending progression-free survival by 94% to one year versus 86%. Photo by Erubiel Flores/Pixabay

The widely used immunotherapy drug nivolumab (Opdivo) is safer and more effective in treating adults and children with advanced Hodgkin lymphoma than the targeted therapy now used as standard of care, new clinical trial results show.

Nivolumab outperformed the drug brentuximab vedotin (Adcetris), extending progression-free survival by 94% to one year versus 86%.

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Nivolumab also produced significantly fewer side effects than brentuximab vedotin, which was the first new therapy developed for Hodgkin lymphoma, Herrera said in a presentation Sunday at the American Society for Clinical Oncology (ASCO) annual meeting. ) in Chicago.

“Based on these data, nivolumab is poised to become a new standard of care for advanced-stage Hodgkin lymphoma,” Herrera said.

Hodgkin lymphoma is a type of cancer that starts in white blood cells called lymphocytes, according to the American Cancer Society.

According to ASCO, 8,830 new cases of Hodgkin’s lymphoma are expected to be diagnosed in the United States in 2023, and 900 patients will die from the cancer. The five-year survival rate for advanced disease is 83%.

“It disproportionately affects young patients, people in their teens, 20s, 30s,” Herrera said. “There is a long history of treating this cancer and over the years we have used increasing doses of radiation and increasing doses of chemotherapy to try to maximize cure.”

Approved in 2018 as a first-line treatment for adults with advanced Hodgkin lymphoma, brentuximab vedotin is an antibody-based drug that attaches to cancer cells and releases a drug that causes cell death.

Adding brentuximab vedotin to chemotherapy improved outcomes and survival, but the drug also increased side effects in both adult and pediatric patients, Herrera said.

Additionally, as many as 60 percent of pediatric patients with Hodgkin’s lymphoma also required radiation therapy with this regimen, increasing the risk of long-term health problems.

The advent of nivolumab offered a potential alternative to brentuximab vedotin, Herrera said.

Some cancer cells carry a protein called PD-L1 that essentially masks them from being detected by T cells. Nivolumab stops PD-L1 from working, allowing immune cells to target and destroy tumours.

“Hodgkin’s lymphoma is the poster child for the use of PD-1 blockade,” Herrera said. “There are genetic changes in the Hodgkin’s lymphoma cancer cell that lead to the expression of PD-1 ligands on the surface of Hodgkin’s lymphoma cells.”

Nivolumab is already approved for the treatment of a broad range of cancers, including non-small cell lung cancer, melanoma, kidney cancer, head and neck cancer, liver cancer, bladder or urinary tract cancer, colon cancer and esophageal cancer, according to the drug manufacturer. Bristol Myers Squibb.

For this study, funded by the National Institutes of Health, researchers recruited nearly 1,000 Hodgkin lymphoma patients, ages 12 and older, who had not received any treatment.

Half were assigned to receive nivolumab with chemotherapy and the rest received brentuximab vedotin and chemo.

At one year later, nivolumab had a 52% reduction in the risk of disease-related death compared with brentuximab vedotin.

Nivolumab patients also had fewer side effects, including fewer infections, sepsis and neuropathy, Herrera said.

“There was more peripheral neuropathy in the brentuximab vedotin arm, and I can’t stress enough how important neuropathy is as a side effect in these young patients who have the rest of their lives ahead of them,” Herrera said. “It’s great to cure cancer, but it’s hard to live without being able to feel your fingers and toes.”

About 22 percent of brentuximab vedotin-treated patients had to stop treatment due to side effects, compared with 11 percent of nivolumab patients, Herrera said.

These findings could mean a new standard of care for both adults and children, said Dr. Julie Gralow, ASCO’s chief medical officer.

“I can tell you that Hodgkin’s lymphoma doctors are really excited about nivolumab,” Gralow said.

Dr. Oreofe Odejide, a hematologist oncologist at the Dana-Farber Cancer Institute in Boston, agrees.

“This study was an unprecedented effort across all of the North American clinical trial cooperative groups to improve the cure rate in advanced-stage Hodgkin lymphoma and harmonize treatment approaches between pediatric and adult patients,” Odejide said in a news release. . “Collaborations between adult and pediatric groups have helped pave the way for a new standard of care that is better tolerated and results in a higher proportion of patients with durable remissions.”

Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.

More information

The American Cancer Society has more on Hodgkin’s lymphoma.

Copyright 2023 HealthDay. All rights reserved.

#Evidence #shows #immunotherapy #drug #Opdivo #safe #effective #Hodgkins #lymphoma

Ozempic is taking China by storm. Drug makers are scrambling to ramp up supplies | CNN business

Ozempic is taking China by storm.  Drug makers are scrambling to ramp up supplies |  CNN business


Hong Kong
Cnn

Ozempic, originally a drug to treat diabetes, is in high demand around the world with celebrities and social media users touting it as a weight loss wonder drug, despite some concerns from medical experts. Now the frenzy is sweeping China, where being skinny is a prevalent beauty standard, leading to shortages in the country.

Chinese social media apps, such as Douyin and Xiaohongshu, have been flooded with posts from users boasting that they have easily lost 10 or more pounds in a month with just a few injections of Ozempic, which is the brand name for semaglutide.

This is a wonder drug, according to a popular series of posts on Xiaohongshu, a Chinese social app similar to Instagram. No diet, no exercise, you can lose weight even when lying down.

Ozempic was officially approved in China in April 2021 for the treatment of type 2 diabetes. But users can get it from doctors for other uses or buy it on e-commerce platforms such as Taobao and JD.com (JD) with prescriptions of other people.

Medical experts say that the drug can have serious side effects. Studies and patient reports show that many patients see their weight rebound soon after stopping the injections.

But its growing popularity in China means many hospitals and pharmacies have run out of Ozempic since late last year, according to the state-owned Peoples Daily Health.

This has caused problems for patients with diabetes who depend on the drug.

A doctor at Sun Yat-sen University’s First Affiliated Hospital in the megacity of Guangzhou told official media last month that the hospital briefly ran out of Ozempic due to increased demand from patients trying to lose weight. The hospital has since stopped prescribing it to people who don’t have diabetes.

The hype on social media was so huge that Xiaohongshu launched a crackdown in February and deleted more than 5,000 posts sharing weight loss experiences with Ozempic.

The social media platform accused many posts of exaggerating the effectiveness of the drugs as a weight loss aid and warned its users not to blindly believe such content.

The platform also launched a pop-up alert reminding users searching for the drug online to go to official medical facilities for treatment.

But that wasn’t enough to calm the frenzy. People in China, especially women, have long been pressured to conform to beauty standards that emphasize an extremely slim figure.

As demand has increased, online prices have soared. The official cost of a 1.5mg dose of Ozempic is 478 yuan ($67) in public hospitals, according to China’s National Drug Reimbursement List.

But prices for the same drug currently range from 36% to 151% higher on online shopping site Taobao.

According to its manufacturer, Danish pharmaceutical company Novo Nordisk (NONOF), Ozempic had sales of DKK 303 million ($44 million) in China in the nine months following its launch in April 2021.

The following year, sales in the country increased more than sevenfold to DKK 2.2 billion ($316 million).

The weight loss drug market in China is expected to grow in the coming years.

A late 2020 government report said that more than 50 percent of adults in China were overweight, which is defined as a body mass index (BMI) greater than 24.0.

Kevin Frayer/Getty Images/FILE

Travelers wait for trains on January 15, 2023 in Shanghai. The Chinese government says more than half of adults in the country are overweight.

Total sales of GLP-1 drugs, a class of diabetes drugs that includes semaglutide, could peak at 40 billion yuan ($5.6 billion) in China, according to an estimate by Shanghai-based Tebon Securities last October. He did not provide a timeline.

This would represent an increase of over 600% over the current market size.

Both Western and Chinese drugmakers want a share of the growing market.

Novo Nordisk has applied to the Chinese drug regulator to expand the scope of use of semaglutide, according to the National Medical Products Administration. Its website showed the regulator received the application on Saturday.

State media speculated that the application would be for weight loss. The drugmaker did not respond to a CNN request for comment.

Several Chinese companies have accelerated the development of generic versions of semaglutide.

Novo Nordisks’ patents for semaglutide in China are expected to expire in 2026, which is the first time that generics could be available for sale.

But this is disputed.

In June 2021, Huadong Medicine, a pharmaceutical company based in Hangzhou, applied to the China State Intellectual Property Office to invalidate the patent. In September 2022, the bureau declared all so-called basic patents for Ozempic invalid in China.

Novo Nordisk appealed the decision. A legal battle is currently underway in the Beijing Intellectual Property Court. If the decision is upheld by the court, a number of generic versions of semaglutide from domestic manufacturers could enter the market.

#Ozempic #China #storm #Drug #makers #scrambling #ramp #supplies #CNN #business

An experimental drug could extend the life of this Parkville girl, but it costs $20,000 a month

An experimental drug could extend the life of this Parkville girl, but it costs $20,000 a month

Ella-Mae Anstaett loves gymnastics, traveling with her family and Disney princesses. She often spends the summer near the water, swimming in the pool or fishing with her little brother.

She is, as it turns out, an ordinary eight-year-old girl. But in early 2022, her mother Alison noticed Ella-Mae holding books inches from her face to read and standing by the TV as she watched her favorite shows.

Alison and her husband Ryan took Ella-Mae to an optometrist who told them she had macular degeneration in her eye known as Stargardt disease which usually affects the elderly. She was referred to Children’s Mercy Hospital, where specialists recommended genetic testing to better understand what was wrong with her.

The results came back in January and were worse than expected. Ella Mae had Batten disease CLN3, a condition so rare that it didn’t show up on a genetic panel when Alison was pregnant.

“It’s pretty upsetting to hear about it initially,” Alison said. “I remember when we got the news, it was like a video call. I was at home and it was like a movie. I literally broke down and cried.”

The diagnosis was devastating for a family that had already weathered a frightening medical diagnosis. When Ella-Mae was two years old, Alison was diagnosed with breast cancer, which is now in remission. Now, they were facing an even steeper uphill battle.

From the outside, Ella-Mae still looks like an ordinary girl who likes to spend her time fishing, playing soccer or exercising. But she is now legally blind and her parents want her to experience as much as possible before her vision completely fades.

The human body is made up of cells that join together to form different tissues and organs. Those cells produce waste. But in children with Batten disease, it’s as if the body’s recycling center isn’t converting that extra waste.

The main symptoms include seizures and progressive vision loss leading to blindness. Other symptoms vary from person to person, but many experience difficulty standing, walking and speaking, poor concentration and progressive loss of language skills.

How quickly the condition accelerates also varies.

The condition usually appears in childhood. The CLN3 variety, which Ella-Mae has, usually develops between 5 and 15 years of age. Most children end up bedridden and unable to communicate.

Estimates suggest there are only 14,000 cases of Batten disease worldwide, affecting about 2 in 100,000 children. Ryan and Alison discovered that they are both genetic carriers.

There is currently no cure.

“Because it’s a genetic condition, we can’t go into the DNA and change the genetic code to make that disease go away,” said Bonnie Sullivan, a clinical geneticist at Children’s Mercy Hospital in Kansas City who worked with the Anstaett family. “A lot of people are working on different treatment options for this, but we’re not there yet.”

Sullivan says there are physical and occupational therapies available that can help people keep functioning as long as possible, and some that can reduce seizures. But stopping the disease altogether is still out of reach, and those with the CLN3 strain usually don’t live beyond their twenties.

Several studies are underway across the country to test different therapies and drugs that could help slow the progression or stop the condition altogether. A drug called miglustat, which people use to treat other genetic disorders, is the focus of a study in Texas.

“This is a community that has really mobilized to provide support to friends and families and those patients, but it’s also really mobilized the research community at large,” Sullivan said.

Alison and Ryan Anstaett

/

Miglustat could help slow the progression of Ella-Mae’s condition, but it’s not FDA-approved, so the Anstaetts will have to pay for the expensive drug out-of-pocket.

Alison and Ryan learned of the Texas trial and visited Gary Clark, a doctor at Texas Children’s Hospital in Houston, where the trial is taking place. While the study shows that miglustat can slow and, in some cases, stop the progression of the disease, participation would mean a 50% chance that Ella-Mae would get the placebo rather than the treatment she needs.

That was a risk the family wasn’t willing to take, but since the FDA has yet to approve the Batten disease drug, the insurance wouldn’t cover it either.

“It was just this constant process of denial, and then I was like, let’s pay for it out of pocket, not really realizing the cost of everything,” Alison said.

Miglustat costs about $20,000 a month without insurance. That means a year’s supply would earn him $240,000 a year.

With no timeline for when the drug might get the green light, if anything, the family has focused on fundraising. First, they started a GoFundMe with just under $37,000 donated so far.

In April, they held a fundraiser in Leavenworth with a raffle and auction barbecue dinner. Local businesses provided food and prizes for the drawings, and hundreds of people showed up. There, they raised around $55,000.

The family also has plans for a 5k event on June 24 in Parkville and a poker tournament in Kansas City in July.

Since miglustat would be a lifetime commitment, the family needs a financial cushion to support payment for the drug when times are tough. They hope they have enough money to pay for a year’s supply before Ella-Mae starts the medicine.

Ryan Anstaett says they are getting help from local organizations.

“We are not fundraisers,” he said. “It wasn’t something we normally do, but we’re going to need a lot of help figuring out how to navigate that path.”

Alison and Ryan Anstaett

/

In April, the Anstaett family held a Leavenworth fundraiser with a barbecue, raffle, and auction to raise money for miglustat. In total, they raised $55,000 at the event.

Ella Mae is now legally blind. With the vision she left behind, Alison and Ryan want to imprint as many memories as possible, knowing that five to ten years from now she may not be able to commit to the same.

So far, they’ve gone to the beach to swim with dolphins, visited their grandparents, and even visited Disney World, where Ella Mae dressed up as a princess and rode across the courtyard in a carriage as park staff and visitors serenaded her.

“You could tell by her face, she really felt like a princess,” Ryan said. “She asked us, why does everyone keep calling me Princess?

A few months ago, Ryan and Alison spoke with Ella-Mae’s gym instructor about the possibility that she may soon have to stop participating. But the instructor told them that wouldn’t be necessary and that they would help accommodate Ella-Mae if it was an activity she enjoys.

These little things help keep your spirits up like messages of support from neighbors or home-cooked meals from friends and family. The Anstaetts say these acts of kindness give them the strength to keep raising money to get Ella-Mae the medicine she needs.

“Even if people can’t donate money, just spread awareness because someone needs to know something,” Ryan said. “Just share our story.”

You can find updates about Ella-Mae and Anstaett’s journey on Facebook.


#experimental #drug #extend #life #Parkville #girl #costs #month

Merck is suing the US government over its plan to negotiate Medicare drug prices, it says

Merck is suing the US government over its plan to negotiate Medicare drug prices, it says

Pharmaceutical maker Merck is suing the US government over its plan to allow Medicare to negotiate prices for a handful of drugs, calling it “extortion”.

The plan, part of 2022 Inflation Reduction Actshould save taxpayers billions of dollars on common drugs that the government pays for. The law requires the Center for Medicare and Medicaid Services to select 10 drugs with no generic or biosimilar equivalents for government price negotiation. (The list will eventually expand to 20 drugs.)

In its lawsuit, filed Tuesday in federal court in the District of Columbia, Merck called the program “a farce” that “involves neither real ‘negotiations’ nor real ‘settlements.'” and Human Services selects the drugs to include and then imposes a discount, threatening drugmakers with a “ruinous daily excise tax” if they reject the terms.

Merck added that it expects its diabetes treatment, Januvia, to be subject to negotiation in the first round, with diabetes drug Janumet and cancer drug Keytruda affected in subsequent years.

The Rahway, New Jersey-based drugmaker is seeking to end the program. “It is tantamount to extortion,” the complaint reads.

Health and Human Services Secretary Xavier Becerra, named as a defendant in the lawsuit, said in a statement the agency plans to “strongly defend” the drug’s price negotiation plan.

“The law is on our side,” he said.


How to choose the right Medicare plan for you

The lawsuit also names HHS and Chiquita Brooks-LaSure, administrator of the Centers for Medicare and Medicaid Services, as defendants.

Merck said the program violates elements of the Constitution, including the Fifth Amendment requirement that the government pay “‘just redress’ if it takes ‘property’ for public use,” according to the complaint.

The drugmaker noted that Congress could have simply allowed HHS to declare a maximum price it would pay for a drug, but that would have allowed the drugmakers to walk away from the talks, leaving millions of Medicare beneficiaries without essential drugs , says the complaint.

Instead, Merck said the government uses the threat of harsh penalties to commandeer drugs and refuses to pay fair value, forcing drugmakers “to smile, play along and pretend it’s all part of a ‘fair’ exchange.” and voluntary”. That violates the First Amendment, the lawsuit says, calling the process “political kabuki theater.”

Patient advocate attacks Merck

David Mitchell, founder of the advocacy group Patients For Affordable Drugs Now, criticized Merck’s lawsuit as an attempt to “unilaterally set prices that are not related to quality at the expense of patients.”

“The reality is that pharmaceutical companies subject to the new Medicare authority – and already negotiating with every other high-income country in the world – will engage in a negotiation process after setting their introductory prices and enjoying nine years or more than monopoly profits,” Mitchell said in a statement.

He added, “Medicare negotiation is a desperately needed and long-awaited rebalancing of our drug pricing system that will help millions of patients get the drugs they need at prices they can afford, while ensuring continued innovation.”

Medicare is the federally funded coverage program primarily for people age 65 and older. Currently, drug companies tell Medicare how much a prescription costs, leaving the federal government and Medicare beneficiaries to pay.

The drug negotiation provisions of the Inflation Reduction Act mark the first time the federal government has bargained directly with drug companies over the price they charge for some of Medicare’s most expensive drugs. Government negotiations with drug makers and price caps on drugs are common in other developed nations.

Republican lawmakers have also criticized President Joe Biden’s administration over the drug pricing plan, saying it could dissuade drugmakers from developing new treatments.

The federal government is expected to release rules for negotiating drug prices soon. In September, it is expected to publish a list of 10 drugs on which it will start price negotiations next year. Negotiated prices won’t catch on until 2026.

With the report of the Associated Press.

#Merck #suing #government #plan #negotiate #Medicare #drug #prices

Medical Directors Consider Akorn’s Voluntary Drug Recall

To know more:

By James Augustine, MD; and Clayton Kazan, MD

On February 23, 2023, a United States drugmaker, Akorn Operating Company, abruptly closed its doors and filed for Chapter 7 bankruptcy. The company ceased all operations and laid off all of its employees in the U.S. Approximately a week later, the company announced a voluntary recall of its drugs. Here is the corporate language released by the FDA:

The Akorn Trustee initiated and announced a voluntary recall of various human and animal products by the deadline following the closure and quality business disruption of these marketed products. Interruption of the quality program means that the company will not be able to support or guarantee that the products meet all expected specifications through the shelf life stated on the label. Further distribution or use of any remaining products on the market should cease immediately. Akorn requests the destruction of all recalled products. This recall is being conducted with the knowledge of the United States Food and Drug Administration.

Several of Akorn’s drug distributors for US Industry EMS notified their customers of the recall on or around May 11.

What does the Akorn EMS drug recall mean?

Akorn has limited ability to support any future quality issues that may arise during the shelf life of its medications, so it has issued a voluntary recall. There are no specific risks for patients and there are currently no reports of adverse events related to the products that have been recalled. Akorn has manufactured and sold a few products (including adenosine injectables) that are Not be recalled and are monitored under a separate quality programme.

The FDA announcement includes a link to the list of human products included in this recall. EMS suppliers would recognize some of the products made by Akorn, including:

  • Albuterol
  • Levalbuterol
  • Fentanyl
  • Injectable naloxone
  • Injectable hydromorphone
  • Injectable midazolam
  • Injectable lorazepam
  • Proparacaine eye drops
  • Prednisolone oral solution
  • Lidocaine ointment and jelly and solution

Many of these drugs are in short supply, with no alternative source of the drug from other drug manufacturers.

As of now, there is no further clarification on the issue of the recall from the FDA. There are apparently no plans to provide further guidance.



To know more:

To know more:

Research analysis: midazolam versus morphine

Should we use midazolam instead of morphine in congestive heart failure?


It already happened?

There were voluntary drug recalls prior to Akorn’s recall, but due to product contamination and labeling issues. None of these were for drugs used in EMS. This is the first recall that is the result of an unexpected company closure and unrelated to a known quality or labeling issue. Since this is the first recall of its kind, there is no credit for purchased drugs and no replacement products to purchase for recalled products.

What is an EMS leader to do?

The concern is that EMS leaders will see a recall notice and immediately withdraw important medications needed for patient care.

These are important drugs. Our view as Medical Directors is that the recall is not mandatory and does not affect the safety and efficacy of the drugs that have been purchased from this company. The voluntary nature of the recall does not mandate specific actions, as there are no known defects in the products. The recall is a safety precaution on the part of the manufacturer to limit its future liability.

The recalled EMS medicines are essential medicines for patient care and are generally in short supply, so replacements can be difficult or impossible to locate. The decision to destroy the product may lead to patient care issues if an alternative drug is not available for use.

When different manufacturers start making products and selling them in the EMS market, then is the opportunity to replace the drugs covered by this recall with new ones and destroy Akorn products. This decision has budgetary implications, and there is no reimbursement plan at any level for destroyed drugs.

At present, there is no indication that other manufacturers are at risk. We will monitor FDA communications for any changes in the recall status of Akorn-manufactured drugs.

About the Authors

James Augustine, MD; and Clayton Kazan, MD, are emergency physicians and fire/EMS medical directors.


#Medical #Directors #Akorns #Voluntary #Drug #Recall

Merck accuses US of extortion in drug price control lawsuit

External signage at Merck headquarters

Merck is suing the United States over a law giving the federal government the power to negotiate prices for some of the most expensive drugs, arguing parts of the legislation are unconstitutional and amount to extortion.

The US drugmaker on Tuesday said reforms in the Inflation Reduction Act, a central part of President Joe Biden’s agenda to reduce the cost of prescription medicines, violated the first and fifth amendments to the constitution.

This is not negotiation. It is equivalent to extortion. And it violates the constitution in at least two obvious respects, Merck said in a court filing.

The reforms were fiercely opposed by the pharmaceutical industry, which warned they would cripple innovation and hamper the development of life-saving drugs.

The Merck lawsuit is the first filed by a major pharmaceutical company, but analysts predict others are likely to follow suit and sue the government before full implementation of the drug price-negotiating elements of the act by the end of the year. year.

Under the proposed reforms, Medicare, the US taxpayer-funded retirement health program, would be allowed to negotiate prices for a limited number of brand-name drugs. The process is expected to begin in earnest in September, when the Centers for Medicare & Medicaid Services (CMS) will identify 10 expensive drugs that will be the focus of the negotiation.

More drugs are expected to be added to this list over the next few years in a move that the Congressional Budget Office estimates will yield billions of dollars in savings over a decade.

Merck said in its lawsuit that the so-called drug price negotiation program was a sham because it involved neither real negotiation nor real deals. The unique purpose of this scheme was for Medicare to get prescription drugs without paying fair market value, he said.

Once the government unilaterally selects a drug for inclusion in the program, its manufacturer is required to sign an agreement promising to sell the drug to Medicare beneficiaries at any fair price dictated by the agency, which must represent at least a 25-60 % discount, Merck said.

If a manufacturer refused to participate in this negotiation or refused to agree to sell at the stipulated price, he would incur a ruinous daily excise tax equal to multiples of the drugs’ daily revenue, the drugmaker added.

Xavier Becerra, US health secretary, said on Tuesday: We strongly defend the presidential drug price negotiation law, which is already lowering health care costs for older adults and people with disabilities. The law is on our side.

Raymond James & Associates analyst Chris Meekins said Merck was the first, but probably not the last, major drugmaker to challenge the government.

Of course, when you talk about a policy that will likely remove $150 billion from the pharmaceutical sector in a decade based on estimates from the Congressional Budget Office, he’s been pretty clear. [the] the industry would sue to try to stop it.

Christopher Viehbacher, chief executive of Biogens, told an audience at a biotech conference in Boston that the company would consider filing its own lawsuit against the IRA.

He said Merck’s claim that the reforms were extortion was accurate.

Roche told the Financial Times it is reviewing its legal and policy options regarding the negative impacts of the IRA on patients and innovation.

Legal experts said the challenge to the IRA could find a sympathetic hearing from US courts, particularly as Merck has indicated it is ready to fight its case all the way to the Supreme Court.

Matt Wetzel, a partner in the life sciences division of Goodwin, a law firm, said Merck’s lawsuit highlighted the coercive elements of the drug pricing reforms, which included significant restrictions on the ability of drugmakers to appeal the decisions CMS and the lack of real negotiation. This might be viewed sympathetically by US courts, he said.

One question, however, is whether a court will find that a business has still been harmed or injured as a result of IRA provisions or whether that harm or injury will not actually occur until September 1 of this year, when the top 10 drugs will be selected for the program, Wetzel said.

Additional reporting by Hannah Kuchler

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Merck sues law that allows Medicare to negotiate with drug makers

Merck sues law that allows Medicare to negotiate with drug makers

Pharmaceutical company Merck sued the government Tuesday over a federal law that allows Medicare to negotiate prices directly with drug makers for the first time.

The Merck lawsuit, filed in federal court in Washington, is the drug industry’s most significant move yet to thwart a major health care policy change, which takes effect in 2026. Democrats pushed through the Medicare negotiating program last summer as a provision of the Inflation Reduction Act, framing it as a way to lower drug prices.

Only certain drugs will be subject to negotiation with Medicare and only after they have been on the market without competition for years. But Merck, which generated $14.5 billion in profits last year, said in a statement Tuesday that the law will stifle the ability of it and its colleagues to make risky investments in new treatments.

Other pharmaceutical companies have suggested they will choose to cut some drug development programs due to the expected dent in their revenues. Several have already said they were reevaluating their research plans.

Merck said it was seeking a court order or other legal remedy that could exempt Merck from having to participate in the trading program.

Xavier Becerra, secretary of health and human services, said in a statement that the Biden administration will vigorously defend the law. The law is on our side, he said.

In the complaint filed Tuesday, Merck’s attorneys at the Jones Day Law Firm say the Medicare negotiation program is unconstitutional. They say the program would force Merck to supply its products at government-set prices, violating a Fifth Amendment clause that prohibits the government from taking private property for public use without just compensation. They also allege that the program would violate Merck’s free speech rights by forcing the company to sign a deal it didn’t agree with after the negotiations were done.

But several experts studying the field have said the constitutionality arguments are weak and will face an uphill battle in court.

What Merck argues is that coercion is actually creating a freer and more rational market that will address a crucial root cause of high drug prices, said Dr. Ameet Sarpatwari, a drug policy expert at Harvard Medical School.

Experts noted that the negotiation process gave drugmakers the leeway to reject the final Medicare offer and walk away without a deal if they weren’t happy, subject to a fee. But Merck’s lawsuit said that for one of the company’s drugs, the fee for refusing an offer could run into the tens of millions of dollars on the first day and rise to hundreds of millions every day after a few months.

In September, the government plans to announce the top 10 medicines that will be on the market in 2026. A widely used Merck drug for diabetes, Januvia, is likely to be on that list.

The program could also affect Merck’s long-term plans for its golden goose, the blockbuster cancer drug Keytruda. It could be among the first products targeted when negotiations on drugs administered in healthcare begin in 2028.

The current version of Keytruda, delivered by infusion, faces its first competition later that year, so its sales are expected to decline regardless of whether the program targets it. But Merck expected to get significant revenue from a new formulation of Keytruda it’s developing that can be more easily administered under the skin. This too could be subject to negotiation, depending on the government’s plans for the programme.

Sheryl Gay Stolberg contributed report.

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Why does diabetes drug Mounjaro work so well for weight loss

Mounjaro diet drug

Mounjaro diet drug

Mounjaro diet drug

Credit – Getty Images Sandy Huffaker for The Washington Post

The latest diabetes drug semaglutide, better known by the brand names Ozempic, Wegovy and Rybelsus, is attracting attention for its ability to both control blood sugar and cause weight loss. But doctors and patients alike predict that the most powerful of these drugs is yet to come, as the U.S. Food and Drug Administration is considering approving Eli Lilly’s drug tyrzepatide (trade name: Mounjaro) for the loss of weight by the end of the year.

In studies that Lilly has submitted to the FDA, the company has shown that Mounjaro, which is already approved to treat type 2 diabetes, can reduce body mass among users at its highest dose by up to 15%. While semaglutide targets one molecule, glucagon-like peptide-1 (GLP-1), involved in insulin secretion, tirzepatide is the first to target two: GLP-1 and glucose-dependent insulinotropic polypeptide (GIP). ).

In a new study published in Metabolism of nature, an international group of researchers, in collaboration with scientists from Eli Lilly and Novo Nordisk (the creator of Ozempic and Wegovy), sought to understand how tyrzepatide produces its strong effects on blood sugar and weight. Working with both mice and cultures of human insulin-producing pancreatic cells, the team conducted a series of experiments to better understand the factors behind the drugs’ dual action.

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The historical narrative in the field has been that GIP is doing everything GLP-1 is doing, just not as well, says Jonathan Campbell, an associate professor of medicine at Duke University and the study’s senior author. Researchers have known that GLP-1 acts on cells in the pancreas and stimulates the production of insulin, which breaks down glucose in the body. It also works on the digestive system, suppressing hunger signals sent to the brain and curbing appetite. GIP has similar effects, but they are generally not as powerful.

The scientists therefore expected to find that tyrzepatide worked primarily by activating GLP-1 receptors in the body and wondered whether GIP would have an additional impact. Since the molecules are very similar, targeting both would not necessarily lead to an additive effect. Instead, the two entities could be competing to bind to the same cell receptors, both trying to go through the same door at the same time, Campbell says.

But to their surprise, the team found that tirzepatide actually triggers a potent GIP response. GIP was imperative, Campbell says. Indeed, in experiments on insulin-producing pancreatic cells donated by eight volunteers, the researchers found that if GIP was blocked in these cells, preventing the drug from binding to GIP receptors, the drug had no effect on stimulating insulin production. . When the GIP receptors weren’t blocked, the cells produced insulin.

This was surprising to us, and the opposite of what we thought, she says.

to know more: What’s missing from Ozempic’s obsession with food and health

The reason may have something to do with the differences between mice and humans. Scientists rely heavily on mouse models to understand how things like GIP and GLP-1 work in living organisms, but it turns out that GIP receptors are different in human cells. While the genetic sequences for GLP-1 receptors in mice and humans are identical, the sequences for GIP receptors in the two species are not. This is a problem, since the most efficient way to understand how GIP works is to study human versions of the receptors in mice. All of the data examining tyrzepatide mechanistically has been obtained primarily in mouse models, says Campbell. So we thought it was important for researchers to know that there are confounding variables.

The studies are an intriguing first step in answering questions about whether the latest class of GLP-1-based diabetes and weight-loss drugs might be more effective when combined with GIP-based drugs. More studies would be needed to explore whether targeting not just one, but several processes involved in insulin production and weight might be more effective. If that were the case, doctors would have different tools that would give them more options for treating people, Campbell says.

This study shows that for insulin secretion, which is an important biological action for glucose control, GIP appears to be very, very important, he says. Taking that scientific tip, Campbell hopes to build on these findings by studying GLP-1 and GIP in larger numbers of human cell samples. And since the volunteers in the current trial spanned a range of BMIs but didn’t have diabetes, he says it’s important to also include cells from people with the condition to better isolate the most efficient way to control blood sugar and weight.

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