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November 7, 2024 Toxic Exposures

Big Pharma NewsWatch

Robert F. Kennedy Jr., Foe of Drug Makers and Regulators, Is Poised to Wield New Power + 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.

Robert F. Kennedy Jr., Foe of Drug Makers and Regulators, Is Poised to Wield New Power

New York Times reported:

When 12,000 public health professionals gathered in Minneapolis last week for the annual meeting of the American Public Health Association, Dr. Jerome Adams, who served as surgeon general in the first administration of President-elect Donald J. Trump, issued a pointed warning about Robert F. Kennedy Jr.

“If R.F.K. has a significant influence on the next administration, that could further erode people’s willingness to get up to date with recommended vaccines,” Dr. Adams said. “I am worried about the impact that could have on our nation’s health, on our nation’s economy, on our global security.”

Now, Mr. Kennedy, a vocal skeptic of vaccines, is in a position to have significant influence, and over a broad range of policy. Mr. Trump’s sweeping electoral victory, with Mr. Kennedy at his side, is — in the eyes of their supporters — not only a mandate but also a repudiation of the public health establishment that has long kept Mr. Kennedy at bay.

Mr. Kennedy’s worldview is embodied in two of his most frequent refrains: “There is nothing more profitable for much of the health care system than a sick child” and “Public health agencies have become sock puppets for the industries they are supposed to regulate.”

Now that Republicans will control the Senate, Mr. Kennedy could theoretically win confirmation for any one of a number of top health jobs: secretary of Health and Human Services, commissioner of the U.S. Food and Drug Administration or director of the Centers for Disease Control and Prevention.

“There is a real mandate victory here, with many millions of people who are first-time Trump voters,” said Calley Means, a health care entrepreneur who has been an adviser to Mr. Kennedy and who was instrumental in connecting him to Mr. Trump. “It is a true mandate to take on broken health care institutions, and to deliver the change.”

Ghost of Pandemic Haunts US Election With Win for Anti-Vax Movement

The Guardian reported:

Donald Trump will be propelled to the White House for a second term amid concerns about inflation kicked off by the pandemic, with a leading vaccine skeptic — Robert F. Kennedy Jr. — at his side, and proposals from conservative supporters to fundamentally restructure public health agencies central to pandemic-era ire.

COVID-19 was never seen as the central issue of the 2024 presidential campaign season, but in the first post-pandemic presidential election, it reverberated as the anti-vaccine movement ascended to its greatest political heights ever. Even in his Wednesday morning acceptance speech, Trump alluded to changes he expects as his administration comes into focus.

The vaccine skeptic and conspiracy theorist Robert F Kennedy Jr. is “going to help make America healthy again,” Trump told supporters, before adding: “We’re going to let him go to it.” Dr Howard Markel, a historian of medicine at the University of Michigan who has studied pandemics, said he was struck by widespread anger, and called the election’s theme “the ghost of pandemic future.”

“Did you ever think,” Markel said he remarked to colleagues, “when you were doing all this hard work and staying up all night that not like 1% or 10%, but like 50% of the country would be saying you destroyed their life and kept them inside, out of harm’s way, during the pandemic?”

FDA Plans to Ban Popular Cold Med

MedPage Today reported

The U.S. Food and Drug Administration (FDA) announced on Thursday a proposed order to remove oral phenylephrine as an active ingredient in over-the-counter nasal decongestion drugs after a comprehensive review of the available data showed it was not effective.

The agency pointed out that since this is a proposed order companies can continue to market these products until the final order is announced. The order is not based on safety concerns. “It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.

“Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

When pseudoephedrine moved “behind-the-counter” nearly 20 years ago, products containing oral phenylephrine — including brands such as Sudafed PE and Suphedrine PE — have been the only nasal decongestants available without the need for a prescription.

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Vaccine Doses Allocated for 9 African Countries Hardest Hit by Mpox

U.S. News reported

An initial 899,000 vaccine doses have been allocated for nine countries across Africa that have been hit hard by the current mpox surge, the World Health Organization (WHO) and other health organizations said on Wednesday.

The WHO declared mpox a global public health emergency for the second time in two years in August after a new variant of the virus, called clade Ib, spread from the Democratic Republic of Congo to neighboring countries. In September, after facing criticism on moving too slowly on vaccines, the WHO cleared Bavarian Nordic’s vaccine for mpox and said it was considering LC16, made by Japan’s KM Biologics as a potential vaccine option.

The WHO also set up a scheme to help bring mpox vaccines, tests and treatments to the most vulnerable people in the world’s poorest countries, similar to efforts during the COVID-19 pandemic. The global health agency said on Wednesday the newly allocated vaccines will go to the Central African Republic, Ivory Coast, the Democratic Republic of Congo, Kenya, Liberia, Nigeria, Rwanda, South Africa and Uganda.

The largest number of doses — 85% of the allocated vaccines — will go to the Democratic Republic of Congo as the most affected country, the WHO said.

Moderna Disappoints in RSV Debut, Squares up With Pfizer in COVID-19 Vaccine Sales

Fierce Pharma reported

Days after Pfizer and BioNTech reported surprisingly strong sales of their updated COVID-19 vaccines, Moderna has done the same. The Massachusetts-based company said that third-quarter revenue from its Spikevax shot came in at $1.8 billion, with $1.2 billion of the sales coming in the United States. The overall figure topped last year’s performance for the quarter by 3% and smashed the analyst projection of $1.2 billion.

Last week, Pfizer reported third-quarter sales of its COVID-19 shot Comirnaty at $1.4 billion, which was up 9% year over year. Three days ago, BioNTech revealed sales of its COVID-19 vaccine at €1.24 billion ($1.35 billion) in the third quarter, which more than doubled the consensus estimate of $652 million.

Novo Nordisk CEO Warns of Deaths Linked to Compounded Semaglutide

MedicalXPress Reported:

The head of the company that makes the diabetes and obesity drugs Ozempic and Wegovy has warned that compounded versions of the active ingredient in those medications have now been linked to at least 100 hospitalizations and 10 deaths.

“Honestly, I’m quite alarmed by what we see in the U.S. now,” Novo Nordisk President and CEO Lars Fruergaard Jorgensen told CNN on Wednesday. “Patients who believe that they’re getting access to a safe product, and they believe they’re getting semaglutide … I know for a fact that they are not getting semaglutide, because there’s only one semaglutide, and that’s produced by Novo Nordisk, and we don’t sell that to others.”

Compounded drugs are made by pharmacies or manufacturers other than the companies that make approved versions of those medicines, and they typically are allowed when there is a shortage of those drugs.

Abbvie’s Skyrizi Rockets to Top of TV Drug Ad Spenders’ List With Single Largest Monthly Total This Year

Fierce Pharma reported

AbbVie is reaching for the Sky(rizi) as it spent a staggering $51.5 million on TV drug ads for its immunology blockbuster in October. That’s according to the latest figures by real-time ad trackers iSpot.TV, which sees the Big Pharma dig deep into its wallet as it handed over nearly $19 million more for its Skyrizi ads in October compared to September’s commercials. That $51.5 million is also easily the highest single total spent on ads for a drug during one month this year.

In second place is fierce rival Dupixent, the immunology megablockbuster from Sanofi and Regeneron, with the pair spending a healthy $35.2 million in October, though not nearly enough to maintain the first place Dupixent enjoyed last time out.

AbbVie pops back into third place with its second immunology blockbuster in Rinvoq, keeping in the same place it did in September. However, spending jumped massively from  $23.6 million in September to $35.1 million in October.

Total spending across the top 10 pharmaceutical companies for the month also jumped by a huge $268.1 million, up from the already healthy September figure of $197.2 million and by far the highest monthly total of the year.

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