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September 12, 2024 Toxic Exposures

Big Pharma NewsWatch

Many Americans Wary of Vaccines as Fall Flu, COVID Season Looms: Survey + 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.

Many Americans Wary of Vaccines as Fall Flu, COVID Season Looms: Survey

U.S. News reported:

A lot of Americans are on the fence regarding annual flu and COVID-19 shots, a new survey finds.

More than one-third of those polled (37%) said they’d gotten vaccines in the past but don’t plan to this year, according to results from a nationwide Ohio State University Wexner Medical Center survey.

Just a slight majority — 56% — plan to get the flu shot this fall, researchers found.

Less than half (43%) say they’ll get the updated COVID-19 vaccine.

The survey involved 1,006 people who were polled in mid-August.

High Doses of ADHD Meds Could Trigger Psychosis

U.S. News reported:

Prescriptions for amphetamine stimulants to treat ADHD have increased significantly in recent years, particularly during the pandemic.

Unfortunately, high doses of stimulants like Adderall can increase the risk of psychosis or mania by more than fivefold, a new study finds.

Patients had a nearly 63% increased risk of psychosis or mania if they took any prescription amphetamine within the past month, researchers reported Sept. 12 in the American Journal of Psychiatry.

Those on heavy doses of amphetamines were at even greater peril of a psychotic episode, with an 81% increased risk, results show.

The highest risk occurred in patients taking 30 milligrams or more of dextroamphetamine, which corresponds to 40 milligrams of Adderall, the study says.

“Stimulant medications don’t have an upper dose limit on their labels, and our results show that it is clear that dose is a factor in psychosis risk and should be a chief consideration when prescribing stimulants,” said lead investigator Dr. Lauren Moran, a pharmacoepidemiology researcher at McLean Hospital in Belmont, Mass.

The Rise of the Science Sleuths

Undark reported:

On a sweltering day in July 2023, a ragtag group of data wonks sat around a table at U Zlatého Tygra, or the Golden Tiger, a historic bar in Prague’s Old Town. A mild sense of outrage hung in the air between jokes about who among them looked the most Medieval.

The group was discussing the issue of manipulated images and fabricated data in scientific publishing.

Soon someone was passing around a phone showing a black-and-white image with clear traces of tampering.

After a couple more rounds, the group made its way across the ornate cobblestone roads. They brimmed with frustration that, until now, had largely been shared only online. “It’s a toxic dump,” an Italian scientist known to the group by his pseudonym, Aneurus Inconstans, said about science. “It’s not about curiosity anymore, it’s just a career.”

These are the sleuths, as the media often refer to them.

They are a haphazard collection of international acquaintances, some scientists and some not, from the United States, Ukraine, New Zealand, the United Kingdom and elsewhere, who are dedicated to uncovering potential manipulation in the scientific literature.

Daily Pill Cuts Body Weight by up to 13% After 3 Months in Early Trial

NBC News reported:

A daily weight loss pill from Novo Nordisk was shown to lower body weight by up to 13% after three months in a Phase 1 clinical trial, according to findings presented Tuesday at the European Association for the Study of Diabetes annual meeting in Spain.

The rate of weight loss with the experimental pill, called amycretin, appears to be more rapid than what’s seen for other drugs.

“It’s roughly double the weight loss rate seen with current GLP-1 agonists and approaching procedural or surgical-level outcomes,” said Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in North Carolina. “It shows potential promise.”

Dr. Susan Spratt, an endocrinologist and the senior medical director for the Population Health Management Office at Duke Health, said the results looked impressive.

“How could they achieve weight loss that quickly?” Spratt asked. “It’s almost like a miracle pill.”

FDA Scolds AbbVie Over ‘Misleading’ TV Ad for a Migraine Pill Featuring Serena Williams

Stat News reported:

The U.S. Food and Drug Administration (FDA) has scolded AbbVie for making false and misleading claims in a TV ad about a migraine pill that features Serena Williams, the third time this year the agency has taken a major pharmaceutical company to task for its marketing.

The agency is upset with Abbvie for a couple of reasons. First, the TV spot suggests that the medication, which is called Ubrelvy, will “provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated,” according to an Aug. 29 letter that was posted on Wednesday on the FDA website.

Moreover, the regulator also chastised the company for using a “celebrity athlete,” which is problematic in this instance because the ad “amplifies the misleading representations and suggestions made and increases the potential for audiences to find the misleading promotional communication more believable due to the perceived credibility of the source.”

COVID-19 After Vaccination Doesn’t Raise Risk of Autoimmune Disease, Data Suggest

CIDRAP reported

A study of 1.8 million adults published in JAMA Network Open suggests that — except for a slightly higher risk of inflammatory bowel disease and blistering skin disorders in a subgroup hospitalized for SARS-CoV-2 Omicron variant infection — Delta or Omicron BA.1 or BA.2 infection in highly vaccinated adults doesn’t significantly raise the long-term risk of autoimmune diseases.

Led by investigators from the National Centre for Infectious Diseases in Singapore, the study team used the SARS-CoV-2 registry and a healthcare claims database to compare the long-term risk of new autoimmune diseases after Delta or Omicron BA.1 or BA.2 infection in recipients of COVID-19 vaccines and boosters with that in uninfected controls.

The study period was Sept. 2021 to March 2022, with a 300-day follow-up.

Of all participants, 27.2% had COVID-19, 72.8% were controls, 51.9% were women, and the average age was 49 years.

“Studies have reported increased risk of autoimmune sequelae after SARS-CoV-2 infection,” the researchers wrote. “However, risk may potentially be attenuated by milder Omicron (B.1.1.529) variant infection and availability of booster vaccination.”

Danish Mpox Vaccine Maker to Supply Additional 2 Mn Doses in 2024

MedicalXPress reported

Danish drugmaker Bavarian Nordic, on Thursday pledged to supply a further two million doses of its mpox vaccine by the end of the year.

The announcement comes on the heels of the arrival of the first vaccines to the Democratic Republic of Congo (DRC) — the epicenter of the epidemic.

“In response to the current outbreak and the strong demand from governments and organizations… the company has prioritized the production” of its vaccine, Bavarian Nordic said in a press release.

Bavarian Nordic has also said it is ready to produce up to 11 million doses of its vaccine, the only one currently licensed in Europe and the U.S., by 2025.

Questions Linger About Missouri Patient Who Contracted Bird Flu

MedPage reported:

Many questions remain unanswered in the case of the Missouri patient who contracted H5 bird flu without any known exposure to sick or infected animals.

“It does raise the concern level, but there is a lot of information needed to understand how much it raises concern,” said Amesh Adalja, M.D., of the Johns Hopkins Center for Health Security in Baltimore.

James Lawler, M.D., MPH, of the University of Nebraska Medical Center’s Global Center for Health Security in Omaha, echoed that experts have “very limited visibility into what’s truly going on with the spread of H5,” especially as surveillance of dairy herds has “quite honestly, been pathetic.”

The key concern is whether there has been human-to-human transmission, Lawler said: “That’s certainly a concern when you have somebody who has no discernible exposure and who develops disease with H5.”

While that does not seem to be the case at this time, experts are wary about that next step in the trajectory of a virus that has already “ticked a lot of boxes” on its way to becoming a potential pandemic, including being able to infect new host species, Lawler said.

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