Topic: Fda

FDA Commissioner Marty McCary resigned following the controversial authorization of fruit-flavored e-cigarettes by a company called Glass. While Senator Dick Durbin and public health advocates criticized the move as a giveaway to Big Tobacco, reports suggest Donald Trump pressured the agency to fulfill a campaign promise to "save vaping." The new devices include digital age verification via Bluetooth, though critics remain skeptical of their effectiveness in preventing teen addiction.

Former FDA officials defended the decision not to approve the cancer drug Replimune, despite intense pressure from the Wall Street Journal's opinion board and investors like BlackRock. The agency cited a lack of substantial evidence and the company's failure to conduct a proper control group study. Allegations surfaced that the media campaign for the drug was a "stock play" rather than a compassionate plea for melanoma patients, as the company's stock has since plummeted.

Dr. Marty McCary resigned as FDA Commissioner after 13 months, reportedly due to White House pressure to authorize flavored vapes. While McCary was also criticized by Republicans over the abortion pill Mifepristone, the "final straw" was the vaping policy. The hosts find the focus on flavored vapes suspicious and suggest there may be deeper ties to Big Pharma or the tobacco industry.

Former FDA Commissioner Dr. Scott Gottlieb discussed the Hantavirus outbreak on a cruise ship, noting a two-to-six-week incubation period. He disagreed with other experts by suggesting a longer window of observation is needed to determine if additional cases will emerge from the initial exposure.

The FDA is reportedly facing significant internal upheaval, with a loss of nearly half of its medical reviewers in key divisions like oncology and hematology. Dr. Scott Gottlieb noted that the departure of career experts and the influx of political appointees are damaging the agency's ability to regulate 20% of the US economy effectively.

The hosts examine the systemic corruption within the pharmaceutical industry, alleging that the FDA provides "plausible deniability" for doctors who prescribe dangerous drugs. They argue that the revolving door between regulatory agencies and drug companies ensures that safety concerns are suppressed until after significant public harm has occurred.

The mass-produced version of the Pfizer vaccine reportedly used Escherichia coli bacteria, leading to significant contamination with bacterial DNA and increased cancer risks. Meanwhile, in the US, the FDA is criticized for failing to collect $19 billion in fines from pharmaceutical companies that suppressed unfavorable clinical trial results. New FDA Commissioner Dr. Marty McCary recently acknowledged this widespread suppression of data.

Senator Ron Johnson presents data alleging that the FDA and CDC hid safety signals regarding myocarditis and ischemic strokes in elderly vaccine recipients. He claims a forthcoming report will show that officials were aware of "extreme masking" of adverse events in the VAERS database as early as March 2021. Johnson has committed to interviewing and potentially subpoenaing HHS and FDA employees involved in the alleged cover-up.

The FDA has issued a recall for "Gold Lion" and "Lume" aphrodisiac chocolates sold by the California-based company Gear Isle. The products were found to contain undeclared Sildenafil and Tadalafil, the active ingredients in Viagra and Cialis, which can cause life-threatening blood pressure drops when mixed with certain heart medications.

The death of actor James Van Der Beek from stage 3 colorectal cancer has renewed focus on the rising rates of the disease among adults under 50. Medical researchers are struggling to explain the increase in cases, while the FDA recently rejected Moderna's application for an mRNA-based flu vaccine. The segment emphasizes the importance of early screening and awareness.

New research published in the British Medical Journal warns that stopping GLP-1 drugs like Ozempic can lead to rapid weight gain and increased risks of diabetes and heart disease. Meanwhile, CNBC reports that Wall Street analysts at Jeffrey predict airlines will save significantly on fuel costs as the population loses weight. The FDA has also reportedly removed warnings regarding suicidal tendencies from these medications.

The FDA is launching a crackdown on flavored e-cigarettes following a 75% increase in teen vaping over the last year. Commissioner Scott Gottlieb is considering banning flavors like mango and cucumber that appeal to minors. The hosts argue that these regulations are a precursor to heavy taxation and express skepticism about the long-term health effects of "dabbing" and vaping.

Media reports describe surging demand for COVID-19 tests ahead of Christmas as people seek to gather safely. The FDA grants emergency use authorization for Pfizer's antiviral pill, which is touted as 90% effective. The hosts criticize the "psychological operation" of encouraging healthy people to stand in long lines for tests and mock a Canadian PSA featuring a "vaccinated" Rudolph the Red-Nosed Reindeer.

The FDA, under Dr. Vinay Prasad, is reportedly moving away from "immunobridging" studies for vaccine approvals, requiring more rigorous outcome data. This change is linked to revelations of pediatric deaths following COVID-19 vaccinations. Simultaneously, a new actuarial study from Germany published on NIH.gov shows a strong correlation between high vaccination rates and excess mortality in the third year of the pandemic, a topic largely ignored by mainstream media.

Major candy brands like Almond Joy and Mr. Goodbar have subtly changed their labeling from "milk chocolate" to "chocolate candy" or "chocolatey." This shift occurs because manufacturers are replacing expensive cocoa butter with alternative fats like palm oil, which disqualifies the products from the FDA's strict definition of milk chocolate. The hosts warn consumers that "mouth appeal" is being prioritized over traditional ingredients due to rising cocoa costs.

Advocates claim that Long COVID has surpassed asthma as the most common childhood illness in the United States. The discussion at the HHS roundtable focuses on the need for the FDA to rapidly approve treatments so that disabled Americans can qualify for insurance coverage. The hosts question the data behind these claims, particularly regarding the prevalence of the condition in children.

Legal experts discuss a potential strategy by the Trump administration to use Tylenol litigation as a "workaround" to challenge vaccine manufacturer immunity. Because Tylenol does not have the same statutory immunity as vaccines, lawsuits in federal court could force discovery regarding how acetaminophen interacts with vaccinations. This could publicly expose data on vaccine safety and potentially lead to the rescinding of the 1986 Vaccine Injury Act's protections.

A new executive order aims to reinstate 1997-era rules requiring pharmaceutical companies to list all side effects in television advertisements. The hosts suggest this move will result in much longer commercials, potentially benefiting cable news revenue in the short term while discouraging drug companies from advertising due to the negative impact of long side-effect lists.

Maria Bartiromo and Senator Ron Johnson discuss the FDA's updated stance on Ivermectin, which now acknowledges the drug's use for COVID-19. The hosts note that acknowledging effective treatments earlier would have legally prevented the Emergency Use Authorization (EUA) for vaccines. The segment concludes with a final reminder of the September 11th anniversary and the "found passport" narrative.

New FDA regulations and state-level guidelines in Virginia are making it more difficult for residents to obtain COVID-19 vaccines at local pharmacies. Some locations now require a doctor's prescription for the shot, creating hurdles for those under 65 who previously had easy walk-in access.