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September 12, 2023

Big Pharma News Watch

Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them + More

The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.

Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them

The Wall Street Journal reported:

The cancer drug Gleevec went generic in 2016 and can be bought today for as little as $55 a month. But many patients’ insurance plans are paying more than 100 times that.

CVS Health and Cigna can charge $6,600 a month or more for Gleevec prescriptions, a Wall Street Journal analysis of pricing data found. They are able to do that because they set the prices with pharmacies, which they sometimes own.

Once the patent on an expensive medicine runs out, lower-priced copies go on sale, promising significant savings. But certain generic drugs — for cancer, multiple sclerosis and other complicated diseases — are still costing thousands of dollars monthly.

Across a selection of these so-called specialty generic drugs, Cigna and CVS’s prices were at least 24 times higher on average than roughly what the medicines’ manufacturers charge, the Journal found.

The hefty price tags are undermining the benefits of generics — a pillar of efforts to control Americans’ spiraling healthcare spending — while saddling patients, many on fixed incomes and insured by Medicare, with considerable deductible payments or other out-of-pocket costs.

After His Suicide, a Man’s Family Says Ozempic Should Carry a Warning Label

NBC News reported:

Anthony’s sister, Merlene Hall — who asked that he be identified only by his first name to respect his children’s privacy — said her brother became uncharacteristically quiet around the time he started taking Ozempic in February to manage his Type 2 diabetes. By early May, Anthony’s family said, he seemed fatigued, and his newly sullen mood appeared to be getting worse.

On the morning of May 14, Anthony died by suicide at his home in Indiana. Although he had experienced depression in the past, his family was shocked by his death and attributed it to Ozempic.

In this and most other cases of suicide, it is impossible to pinpoint a single cause, as a complex set of factors often interplay. However, as Ozempic and its sister medication, Wegovy, have skyrocketed in popularity, a small number of patients — some with a history of depression — have begun to report experiencing suicidal thoughts that they believe are a side effect of the drug.

The European Medicines Agency said in July that it was reviewing 150 reports of self-injury and suicidal thoughts from people who took GLP-1 receptor agonists, the drug class that includes Ozempic and Wegovy. The U.K.’s Medicines and Healthcare products Regulatory Agency told Reuters that it, too, was reviewing safety data about the drugs following similar reports.

Big Pharma’s Blockbuster Obesity Drug Battle Is Just Getting Started, and It’s Headed for $100 Billion

CNBC reported:

In their most recent earnings reports, Novo Nordisk and Eli Lilly proved why they are the undisputed heavyweights in the prizefight for control of the rapidly growing weight-loss medications market.

Beyond staggering sales figures for Novo’s Ozempic and Wegovy and Lilly’s Mounjaro, news of a study showing Wegovy can reduce the risk of heart disease and the anticipated approval of even more powerful prescription drugs to treat obesity will only strengthen the position of these venerable pharmaceutical giants, which have been in business for 100 years and 147 years, respectively.

Even so, their competitors are not ceding the market to the current leaders. Pfizer, Amgen and other pharmaceutical companies are rushing to develop weight-loss drugs, though they may not be available for another year or more.

570 California Schools Targeted for Low Vaccination Rates

The Mercury News reported:

More than 500 California public schools are being audited by the state because they reported that more than 10% of their kindergarten or seventh-grade students were not fully vaccinated last school year. Schools that allow students to attend school without all their vaccinations are in jeopardy of losing funding.

The audit list, released by the California Department of Public Health, includes 450 schools serving kindergarten students and 176 schools serving seventh graders with low vaccination rates. Fifty-six of the schools serve both grade levels. Another 39 schools failed to file a vaccination report with the state.

“After the personal belief exemption was gone, we found a significant number of schools were behind on their reporting and were allowing a lot of conditional admissions and weren’t following up,” said Catherine Flores Martin, director of the California Immunization Coalition.

Doctor Asks Court to Toss J&J Lawsuit Against Her Over Cancer Research

Reuters reported:

A medical researcher has asked a court to throw out a lawsuit that Johnson & Johnson (JNJ.N) filed against her over her 2019 study on the links between cosmetic talc products and cancer, saying that her research is sound and protected by free speech rights.

Dr. Jacqueline Moline, who has served as a plaintiffs’ expert in more than 200 cases alleging that J&J talc products caused patients to develop cancer, said in a Friday court filing in federal court in Trenton, New Jersey, that the lawsuit was an effort to “intimidate” scientific experts.

Scientific conclusions based on accurate descriptions of the data and methodology used to develop them are protected by the First Amendment of the U.S. Constitution’s protections for free speech and academic freedom, according to Moline’s court filing.

J&J faces more than 38,000 lawsuits alleging that its talc products, including Johnson’s Baby Powder, can contain asbestos and cause cancers including ovarian cancer and mesothelioma.

Moderna to Pay Immatics up to $1.8 Billion in Cancer-Drug Deal

Bloomberg reported:

​​Moderna Inc. agreed to pay German biotechnology company Immatics NV as much as $1.8 billion in a broad-ranging, multiyear collaboration on developing cancer therapies using messenger RNA and other technologies.

Moderna will pay Immatics $120 million upfront and up to $1.7 billion if the work hits certain goals, according to a statement Monday. The companies will collaborate on a variety of products, including antibodies produced through mRNA, cancer vaccines and cell therapy products, most of which have yet to be tested in people.

Moderna has been seeking new ways to deploy its mRNA technology that quickly generated effective vaccines against the coronavirus. Cancer is one of the most promising potential applications, and the company is already working with Merck & Co. on a personalized cancer vaccine for melanoma and other tumors, but testing could take years to complete.

The Immatics collaboration offers a number of opportunities for Moderna to find new applications for its assets. In one part of the joint effort, Moderna will create an mRNA-based vaccine aimed at bolstering an Immatics anti-cancer cell therapy product, called IMA203, which is in early human testing on its own. Immatics will lead early-stage trials of the combination if they come about, the companies said.

Does This Over-the-Counter Decongestant Really Work? FDA Panel to Re-Evaluate Phenylephrine

NBC News reported:

Does a common ingredient used in many over-the-counter cold and allergy medicines actually work to get rid of nasal congestion?

That’s the question the Food and Drug Administration will pose to a panel of outside advisers during a two-day meeting next week to re-evaluate the effectiveness of the ingredient, phenylephrine, which is found in many decongestants.

The stakes are high, experts say, because a committee vote declaring phenylephrine ineffective as an oral decongestant could push the FDA to revoke the drug’s over-the-counter designation as “Generally Recognized as Safe and Effective,” and potentially lead to it being pulled from store shelves. The designation, typically used for older drugs, allows drugmakers to include an ingredient in over-the-counter products without the need to file an FDA application.

Dr. Wynne Armand, a primary care physician at Massachusetts General Hospital, said she does not prescribe the drug. Allowing people to use such medications is harmful not just because they don’t work, she added, but because the drugs come with side effects including headache, insomnia and nervousness.

ADHD Medications Still in Shortage, Frustrating Patients and Doctors

NBC News reported:

Almost a year into the nationwide shortage of ADHD medications, federal agencies and drugmakers are blaming each other for empty pharmacy shelves.

The Drug Enforcement Administration, which sets limits on the types of amphetamines that pharmaceutical companies can use to make the pills, says companies have more than enough raw ingredients to produce stimulant ADHD medications. Drugmakers contest the claim, saying they’ve run out of ingredients and need the DEA’s permission to acquire more.

Dr. Leila Javidi, a primary care doctor in Gahanna, Ohio, has been fielding several hundred calls and messages each month from patients who say finding a stocked pharmacy becomes a time-consuming, frustrating quest.

“Everyone’s angry,” said Javidi. “Panic is a daily occurrence with my patients. The whole thing’s a mess.”

As of Tuesday, the American Society of Health-System Pharmacists, a group that represents hospital and clinic pharmacists, reported supply problems affecting 141 different doses or formulations of stimulant ADHD medications. The shortage began with Adderall last fall but has since had a domino effect, with long- and short-acting versions of methylphenidate (Ritalin and Concerta), as well as Focalin, Vyvanse, and numerous generic equivalents of these drugs now in short supply, too.

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