Two GOP senators are pressing the <a href="https://www.dailywire.com/topic/fda" target="_blank" rel="noopener">FDA</a> to provide data on the effects of a puberty-inhibiting drug recently warned about by <a href="https://www.dailywire.com/news/fda-officials-warn-of-brain-swelling-vision-loss-in-minors-using-puberty-blockers" target="_blank" rel="noopener">some</a> medical experts.
GOP Sens. <a href="https://www.dailywire.com/topic/marsha-blackburn" target="_blank" rel="noopener">Marsha Blackburn</a> of <a href="https://www.dailywire.com/topic/tennessee" target="_blank" rel="noopener">Tennessee</a> and Cynthia Lummis of <a href="https://www.dailywire.com/topic/wyoming" target="_blank" rel="noopener">Wyoming</a> wrote a <a href="https://www.blackburn.senate.gov/services/files/7EDEB96F-2EE4-440A-A274-9DB860C8FE49" target="_blank" rel="noopener">letter</a> to FDA Commissioner Robert Califf on Thursday about the side-effects of gonadotropin-releasing hormone (GnRH) agonists, which are used to treat minors with early-onset puberty, as well as stave off the normal pubescent development of minors who may be considering sex-reassignment surgery.
The FDA added a warning to the use of GnRH agonists in July over reported cases of <a href="https://www.mayoclinic.org/diseases-conditions/pseudotumor-cerebri/symptoms-causes/syc-20354031#:~:text=Pseudotumor%20cerebri%20(SOO%2Ddoe%2D,those%20of%20a%20brain%20tumor." target="_blank" rel="noopener">pseudotumor cerebri</a>, a condition that mimics the symptoms of a brain tumor but has no obvious source. GnRH agonists are <a href="https://publications.aap.org/aapnews/news/20636/Risk-of-pseudotumor-cerebri-added-to-labeling-for?autologincheck=redirected" target="_blank" rel="noopener">found</a> in drugs such as Lupron Depot-Ped, Fensolvi, Synarel, Supprelin LA, and Triptodur.
The senators noted that while GnRH agonists are approved for use by patients with developmental disorders such as central precocious puberty (CPP), which makes a child experience puberty younger than normal, the drug is not approved for gender dysphoric or transgender treatment. According to a <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7497424/" target="_blank" rel="noopener">study</a> published in the National Library of Medicine, GnRH is recommended for initial treatments of minors struggling with gender dysphoria.
“[T]he off-label use of GnRH agonists in connection with diagnoses of gender dysphoria or the provision of transgender care is, by definition, intended to suppress the normal biological processes of puberty beyond the normal age of onset. Given that such off-label use deliberately delays and alters normal development, We are deeply concerned that it could result in significant short-term and long-term risks and adverse effects on adolescent patients,” the senators wrote.
“Our concern has been heightened by reports of increased off-label use of GnRH agonists in connection with transgender care,” they added. They then requested trial studies, cases of negative side-effects, and other information on use of GnRH agonists.
Blackburn and Lummis’ letter comes days after Daily Wire host Matt Walsh posted <a href="https://www.dailywire.com/news/huge-money-maker-video-reveals-vanderbilts-shocking-gender-care-threats-against-dissenting-doctors" target="_blank" rel="noopener">shocking videos</a> of a doctor at a Transgender Clinic at Vanderbilt University Medical promoting transgender surgeries as a “big money maker.” The doctor who made the comments works with adult patients.
The medical center has also detailed transgender surgeries and treatments available for minors. Video from the Vanderbilt Psychiatry YouTube channel reveals the medical center “explicitly [admits] that they will give and have given irreversible hormone drugs to children as young as 13,” Walsh <a href="https://www.dailywire.com/news/gov-bill-lee-calls-for-investigation-of-vanderbilts-pediatric-transgender-clinic-following-matt-walsh-bombshell" target="_blank" rel="noopener">wrote</a>.
The university released a statement after Walsh’s report claiming that reports of its transgender care “misrepresented facts.”
“We have been and will continue to be committed to providing family-centered care to all adolescents in compliance with state law and in line with professional practice standards and guidance established by medical specialty societies,” the statement said.
Blackburn has joined other Tennessee officials in calling for an investigation into Vanderbilt University Medical in the wake of Walsh’s reporting.
“Using children for profit and political gain is deeply disturbing. Experts agree that there have not been enough clinical trials conducted to prove the safety and effectiveness of using these drugs on kids,” Blackburn said in a statement. “These drugs have not been approved for treating children experiencing gender dysphoria, but the left insists on experimenting on these children anyway.”
Zach Jewell contributed to this report.

Marsha Blackburn

GOP Senators Press FDA On Puberty Blocker Risks After Matt Walsh Exposes Vanderbilt Transgender Clinic

Tennessee

Vanderbilt University

The Food and Drug Administration (<a href="https://www.dailywire.com/topic/fda">FDA</a>) is warning against cooking raw chicken in cough syrup.
The warning was prompted by a new social media trend in which people record themselves cooking chicken in NyQuil for online clout. The FDA calls the challenge &#8220;silly and unappetizing&#8221; and &#8220;very unsafe.&#8221; It can also produce toxic fumes.
&#8220;Boiling a medication can make it much more concentrated and change its properties in other ways. Even if you don’t eat the chicken, inhaling the medication’s vapors while cooking could cause high levels of the drugs to enter your body. It could also hurt your lungs,&#8221; says the FDA.
The FDA has previously issued warnings about ingesting cold medicine in social media challenges. A 2020 TikTok challenge encouraged people to take diphenhydramine, which can alleviate allergy and cold symptoms, to induce hallucinations. The agency warned that some people who were participating in the challenge landed in the emergency room or died.
&#8220;If someone takes too much diphenhydramine and is hallucinating, can’t be awakened, has a seizure, has trouble breathing, or has collapsed, immediately get medical attention or contact poison control,&#8221; the <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-problems-high-doses-allergy-medicine-diphenhydramine-benadryl">FDA</a> said.
Dangerous video challenges have been attributed to social media for years. One teen suffered second-degree burns when people started challenging each other to <a href="https://www.washingtonpost.com/news/morning-mix/wp/2014/07/29/kentucky-teen-gets-burned-after-mimicking-fire-challenge-he-saw-online/">light themselves on fire</a> (&#8220;The Fire Challenge&#8221;) with rubbing alcohol in order to try and put out the flames before getting seriously injured. Another boy was <a href="https://www.post-gazette.com/neighborhoods-city/2012/06/29/Boy-12-badly-injured-in-salt-and-ice-challenge/stories/201206290188">injured with cold burns</a> after rubbing himself with salt and applying ice cubes to himself (&#8220;Salt And Ice Challenge&#8221;) in an attempt to see how long he would last. Another doctor <a href="https://www.cbsnews.com/detroit/news/condom-challenge-has-teens-risking-life/">warned</a> in 2013 against inhaling condoms through your nose (&#8220;The Condom Challenge&#8221;) to pull them back out of your mouth. Last summer, two sets of parents <a href="https://www.dailywire.com/news/parents-sue-tiktok-for-damages-after-daughters-allegedly-die-doing-challenge-on-app">filed a lawsuit against TikTok</a> for allegedly participating in a choking challenge (&#8220;The Blackout Challenge&#8221;) in which people strangle themselves until they lose consciousness.
The 2018 Tide Pod challenge — perhaps the most infamous of all social media challenges— erupted when teenagers started putting laundry detergent pods in their mouths. The challenge sparked concerns at Tide, which recruited social media influencers to convince people to stop doing it.
“What the heck is going on people,” Patriots tight end Rob Gronkowski said in a video. “Use Tide pods for washing. Not eating.”
<blockquote class="twitter-tweet">
What should Tide PODs be used for? DOING LAUNDRY. Nothing else.
Eating a Tide POD is a BAD IDEA, and we asked our friend <a href="https://twitter.com/RobGronkowski?ref_src=twsrc%5Etfw">@robgronkowski</a> to help explain. <a href="https://t.co/0JnFdhnsWZ">pic.twitter.com/0JnFdhnsWZ</a>
— Tide (@tide) <a href="https://twitter.com/tide/status/951940660499755008?ref_src=twsrc%5Etfw">January 12, 2018</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
Over 12,000 people called Poison Control in 2017 to report the consumption of Tide Pods. The figure was 14% down from 2015, when a peak of 14,349 people called poison control with Tide Pod concerns, <a href="https://www.washingtonpost.com/news/wonk/wp/2018/01/16/there-were-over-10000-poison-control-calls-for-people-eating-laundry-pods-last-year/">according</a> to The Washington Post.

Raw chicken meat on cutting board. Legs wings and breast

‘Very Unsafe’: FDA Warns Against Cooking Chicken In Cough Syrup

FDA Warns Against Cooking Chicken In Cough Syrup

Social Media

teens

TikTok

The Food and Drug Administration (FDA) issued a safety alert after reviewing some reports of patients who had been diagnosed with cancer after receiving breast implants.
Binita Ashar, the director of the Office of Surgical and Infection Control Devices at the FDA, noted the reports of &#8220;squamous cell carcinoma and various lymphomas&#8221; in scar tissue implants.
&#8220;After an initial extensive review, we currently believe that the risk of SCC and other lymphomas occurring in the tissue around breast implants is rare,&#8221; Ashar <a href="https://www.fda.gov/news-events/press-announcements/fda-issues-safety-alert-squamous-cell-carcinoma-and-various-lymphomas-scar-tissue-around-breast" target="_blank" rel="noopener">stated</a>. &#8220;However, in this case, and when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible.&#8221;
The alert also clarified that the findings were sometimes diagnosed years after receiving implants. The new safety alert also involves a different issue of lymphoma in scar tissue than in a similar risk <a href="https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl" target="_blank" rel="noopener">reported</a> more than a decade ago.
The agency currently states that it does not have enough information to conclude if the implants cause certain cancers or whether some types of implants present higher risks than others. The alert urged any instances of cancer near the scar tissues around breast implants to be reported to the FDA through <a href="https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program" target="_blank" rel="noopener">MedWatch</a>, the agency&#8217;s Safety Information and Adverse Event Reporting program.
The agency plans to conduct further studies in cooperation with the American Society of Plastic Surgeons. The research hopes to identify more details regarding such cases to better address the issue in the future.
&#8220;We also understand that information regarding breast implant risks can be overwhelming for a patient,&#8221; the alert also noted. &#8220;For this reason, we encourage review of our website with attention to patient labeling, which has easy to understand information in the patient brochure.&#8221;
Approximately 400,000 women get breast implants in the U.S. in a typical year, <a href="https://www.nytimes.com/2022/09/08/health/breast-implants-cancer.html" target="_blank" rel="noopener">according to</a> a report by The New York Times. Of the number, 300,000 are for cosmetic reasons, and 100,000 are for reconstruction after mastectomies to treat or prevent breast cancer.
Those who have received breast implants following breast cancer are already at higher risk of future illness. Other factors, including nicotine usage, can also increase the risk of lymphoma.
The FDA is not recommending that women remove breast implants due to its warning. Instead, any concerns should be reported to a healthcare provider for additional consideration.
In October 2021, the FDA took <a href="https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants" target="_blank" rel="noopener">several steps</a> to improve risk communications regarding breast implants. The changes included orders restricting who can sell implants, new box label warnings, and a patient decision checklist, among other updates.
&#8220;By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery,&#8221; Asher said at the time. &#8220;As the FDA continues to evaluate the overall effects of breast implants in patients, today’s actions help ensure that all patients receive the information they need to make well-informed decisions affecting their long-term, personal health.”

FDA Warns Breast Implants May Be Linked To More Cancers

FDA Issues Safety Alert Over Cancer Reports Related To Breast Implants

Cancer

Safety

The Food and Drug Administration (FDA) authorized updated COVID booster shots on Wednesday created to specifically target subvariants of Omicron.
The FDA shared the approval in a Wednesday announcement that amended the emergency use authorizations for both Pfizer/BioNTech and Moderna&#8217;s boosters.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” FDA Commissioner Robert Califf said in the <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use" target="_blank" rel="noopener">statement</a>. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”
Pfizer&#8217;s booster will be made available for those 12 years old and older. Moderna&#8217;s approval is for those 18 years old and above.
The boosters include the components of the original COVID vaccine along with an mRNA component to target the BA.4 and BA.5 subvariants of Omicron.
The most recent <a href="https://covid.cdc.gov/covid-data-tracker/#variant-proportions" target="_blank" rel="noopener">data</a> provided by the CDC reveals that the BA.5 variant is responsible for 88.7% of all new cases between August 21 and August 27. The BA.4 variant included an additional 3.6% of new cases.
“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” <a href="https://www.businesswire.com/news/home/20220822005376/en/Pfizer-and-BioNTech-Submit-Application-to-U.S.-FDA-for-Emergency-Use-Authorization-of-Omicron-BA.4BA.5-Adapted-Bivalent-COVID-19-Vaccine" target="_blank" rel="noopener">said</a> Albert Bourla, chairman and CEO of Pfizer.
“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges,” he added.
For both booster shots, individuals are eligible “if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine,” according to the FDA.
A committee from Centers for Disease Control and Prevention is expected to approve the final step in the process this week before the new vaccine boosters begin distribution later this month.
Some health professionals are concerned regarding the new FDA approval, however, as <a href="https://www.dailywire.com/news/report-covid-boosters-could-be-authorized-for-use-before-human-testing-is-completed" target="_blank" rel="noopener">testing in humans</a> has not yet been completed.
“I’m uncomfortable that we would move forward — that we would give millions or tens of millions of doses to people — based on mouse data,” Paul Offit, an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, <a href="https://www.wsj.com/articles/latest-covid-boosters-are-set-to-roll-out-before-human-testing-is-completed-11661679003" target="_blank" rel="noopener">told</a> the Wall Street Journal in a report published on Sunday.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the news release that much care has been given regarding the safety of those taking the new boosters.
“The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” he stated.

COVID vaccine

FDA Authorizes Pfizer and Moderna’s Updated COVID Boosters

FDA Authorizes Pfizer and Moderna’s Updated COVID-19 Boosters

COVID-19 Vaccine

Moderna

Pfizer

The Food and Drug Administration (FDA) could rule this week that COVID booster shots may be distributed to Americans before the completion of testing in humans.
The lack of human studies for the new booster has led to concerns about its upcoming release.
“I’m uncomfortable that we would move forward—that we would give millions or tens of millions of doses to people—based on mouse data,” Paul Offit, an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, <a href="https://www.wsj.com/articles/latest-covid-boosters-are-set-to-roll-out-before-human-testing-is-completed-11661679003" target="_blank" rel="noopener">told</a> the Wall Street Journal in a report published on Sunday.
The updated Pfizer and BioNTech vaccine contains mRNA of the original SARS-CoV-2 spike protein found in the current vaccine together with mRNA spike protein for the Omicron BA.4/BA.5 variant. Pfizer and BioNTech said it is starting a human study of the booster shot this month, though it would not be completed until after its potential approval and distribution to Americans.
Pfizer and BioNTech have requested that the FDA grant an emergency use authorization for its COVID vaccine adapted to the BA.4/BA.5 versions of the Omicron variant. The emergency request would allow the booster&#8217;s approval without the traditional studies required for such a vaccine.
The new booster dose is intended for individuals 12 years of age and older and would be available to ship immediately, according to a news release from the company.
“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” <a href="https://www.businesswire.com/news/home/20220822005376/en/Pfizer-and-BioNTech-Submit-Application-to-U.S.-FDA-for-Emergency-Use-Authorization-of-Omicron-BA.4BA.5-Adapted-Bivalent-COVID-19-Vaccine" target="_blank" rel="noopener">said</a> Albert Bourla, Chairman and CEO of Pfizer.
“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges,&#8221; he added.
The most recent <a href="https://covid.cdc.gov/covid-data-tracker/#variant-proportions" target="_blank" rel="noopener">data</a> provided by the CDC reveals that the BA.5 variant is responsible for 88.7% of all new cases between August 21 and August 27. The BA.4 variant included an additional 3.6% of new cases.
In addition to Pfizer/BioNTech, Moderna has also requested FDA approval for its updated COVID vaccine targeting the latest coronavirus strains. If approved, it could ship in September.
&#8220;We have worked closely with the FDA to ensure that Americans will have access to Moderna&#8217;s updated, bivalent booster, which, if authorized, may offer higher, broader, and more durable protection against COVID-19 compared to the currently authorized booster,&#8221; <a href="https://investors.modernatx.com/news/news-details/2022/Moderna-Completes-Application-To-U.S.-Food-And-Drug-Administration-For-Emergency-Use-Authorization-Of-Omicron-Targeting-Bivalent-Covid-19-Booster-Vaccine-mRNA-1273.222/default.aspx" target="_blank" rel="noopener">said</a> Stéphane Bancel, Chief Executive Officer of Moderna. &#8220;Moderna&#8217;s mRNA platform has enabled us to develop, study, and deploy bivalent booster vaccine candidates that demonstrate superior protection against all tested COVID variants, in record time. Our commitment to using cutting-edge science to protect the world against the ongoing COVID threat continues.&#8221;
Moderna noted that it launched a clinical trial of the booster earlier this month. Its press release stated that its application &#8220;is based on preclinical data as well as clinical trial data available for the company&#8217;s BA.1 Omicron-targeting bivalent booster candidate, mRNA-1273.214.&#8221;
Full human clinical trials are not required for emergency use approval. However, the push for booster approvals ahead of more developed human studies could cause hesitancy among some people eligible for the vaccine.

COVID-19 vaccine

Report: COVID Boosters Could Be Authorized For Use Before Human Testing Is Completed

Report: Covid Boosters Could Be Authorized For Use Before Human Testing Is Completed

COVID

Health

The Centers for Disease Control and Prevention (CDC) <a class="editor-rtfLink" href="https://www.cdc.gov/ecoli/2022/o157h7-08-22/index.html" target="_blank" rel="noopener">announced</a> Wednesday that a “fast-moving” E. Coli outbreak hospitalized nine people and left 20 others ill in Michigan and Ohio.
No deaths have been reported.
Officials warned that the actual number of people infected is likely higher than the number reported, as the food source from which the outbreak originated has yet to be identified.
Symptoms of the infection vary for each person, but CDC officials said they could often include severe stomach cramps, bloody diarrhea, and vomiting. Others may come down with a low-grade fever or experience signs of dehydration, such as a reduction in urination, dry mouth and throat, and episodes of dizziness when standing up.
“If you have symptoms of coli, help us solve this outbreak,” the health agency said. “Write down what you ate in the week before you got sick, report your illness to your local or state health department, and answer public health officials’ questions about your illness.”
The Michigan Health Department of Health and Human Services <a class="editor-rtfLink" href="https://www.michigan.gov/mdhhs/inside-mdhhs/newsroom/2022/08/16/e-coli" target="_blank" rel="noopener">reports</a> it’s currently investigating a recent increase in the number of illnesses related to E. Coli bacteria.
The department reported 98 cases of infection in August, compared to the 20 cases reported last year during the same period.
“While reports of E. coli illness typically increase during the warmer summer months, this significant jump in cases is alarming,” said Dr. Natasha Bagdasarian, the department’s chief medical executive. “This is a reminder to make sure to follow best practices when it comes to hand hygiene and food handling to prevent these kinds of foodborne illness.”
Symptoms typically appear about three to four days after exposure, but the department said sometimes they could last as long as 10 days.
While the disease can impact everyone, young children will likely experience a more severe illness.
The Washington Post <a class="editor-rtfLink" href="https://www.washingtonpost.com/health/2022/08/18/cdc-e-coli-outbreak-michigan-ohio/" target="_blank" rel="noopener">reports</a> that last year, an outbreak traced back to ingredients from packaged salad products out of Arizona and California farms killed one person and infected 10 others in Alaska, Washington, Oregon, and Ohio.
CBS News <a class="editor-rtfLink" href="https://www.cbsnews.com/news/e-coli-outbreak-michigan-ohio-cdc/" target="_blank" rel="noopener">reports</a> one of the most recent significant outbreaks occurred toward the end of 2019, where approximately 200 people across half of the U.S. were infected after eating contaminated romaine lettuce.
U.S. Food and Drug Administration officials would report months later that the outbreak occurred due to close “proximity of cattle to produce fields.”
The Washington Post <a class="editor-rtfLink" href="https://www.washingtonpost.com/health/2022/08/18/cdc-e-coli-outbreak-michigan-ohio/" target="_blank" rel="noopener">reports</a> the year prior, 210 people across 36 states were infected with another outbreak sparked by romaine lettuce out of Yuma, Arizona, which killed five people and hospitalized 96 others.
CDC officials <a href="https://www.cdc.gov/ecoli/pdfs/CDC-E.-coli-Factsheet.pdf">said</a> E. Coli-borne toxins infect about 265,000 people in the United States yearly, with approximately 3,600 requiring hospital treatment and 30 dying from it.
Officials urge everyone to wash their hands, rinse food and vegetables, and separate raw meat from other foods to prevent infection.

Escherichia coli (E. coli) colonies

‘Fast-Moving’ E. Coli Outbreak Infects Michigan And Ohio: Health Officials

Food

Michigan

Ohio

Daily Wire host Matt Walsh unearthed an <a href="https://twitter.com/MattWalshBlog/status/1560027417456025601">interview</a> on Wednesday between a Pennsylvania politician and a pediatrician who laid out the process for children to medically transition genders as young as ten years old.
The interview, between Rep. Dan Frankel (D-PA) and Children’s Hospital of Pittsburgh pediatrician Dr. Gerald Montano, featured Montano explaining what “gender-affirming care” looks like for children at five and 10 years old. It was first published in March 2021.
Montano, who also runs a gender and sexuality program at the hospital, said rather than providing medical intervention for a five year old, doctors refer the child to a therapist who explores their so-called gender identity “to make them feel comfortable with how they feel about themselves.”
&#8220;For a 10 year old, that really depends on where they are in puberty because for some people — especially those who are assigned female at birth — they might start having signs of puberty,&#8221; Montano said. &#8220;And then there is a discussion on whether or not puberty blockers may be warranted for that individual because they can become really distressed if they&#8217;re starting to develop secondary sex characteristics that really distresses them.&#8221;
Frankel asked about surgical options for children and when that becomes part of the discussion.
Montano said the vast majority of surgeries are not done until the child turns 18 years old, depending on the type of operation.
&#8220;The only exception is top surgery in which sometimes that is done earlier,&#8221; he said, adding that the choice is an &#8220;intensely personal decision&#8221; between the child, the family, and the medical professionals.
&#8220;Not every transgender person or gender non-binary individuals need to go through surgery, and again, at the end of the day, it&#8217;s an intensely personal decision that they have to take to make themselves feel affirmed in their gender identity,&#8221; Montano said.
And despite the U.S. Food and Drug Administration (FDA) issuing a warning last month that puberty blockers could cause brain swelling, loss of vision, and serious risks for children injecting the hormone, Montano claimed the hormones are &#8220;safe&#8221; and completely reversible with no long term effects after usage stops — a message often promulgated by &#8220;gender-affirming care&#8221; activists.
The Daily Wire previously reported that FDA officials said a plausible association between using puberty blockers and pseudotumor cerebri, which displays symptoms similar to a brain tumor, was identified in six young girls between the ages of 5 and 12.
&#8220;Five were undergoing treatment for central precocious puberty and one for transgender care,&#8221; FDA officials report. &#8220;The onset of pseudotumor cerebri symptoms ranged from three to 240 days after GnRH agonist initiation.&#8221;
Daily Wire host Matt Walsh has exposed through his recent documentary &#8220;<a href="https://www.dailywire.com/videos/what-is-a-woman">What Is A Woman?</a>&#8221; that Lupron, a type of puberty blocker, is the same drug used to chemically castrate sex offenders, <a class="editor-rtfLink" href="https://twitter.com/MattWalshBlog/status/1560028484625465345" target="_blank" rel="noopener">adding</a> that &#8220;it is an objective fact that [Children&#8217;s Hospital of Pittsburgh] chemically castrates children.&#8221;
<blockquote class="twitter-tweet">
Here is an interview between Democrat congressman Dan Frankel and Dr <a href="https://twitter.com/GeraldTMontano1?ref_src=twsrc%5Etfw">@GeraldTMontano1</a> of the Children&#8217;s Hospital of Pittsburgh. Montano clearly lays out how children at ten begin to medically transition. He admits that minor girls have their breasts amputated. <a href="https://t.co/puQon02y81">pic.twitter.com/puQon02y81</a>
— Matt Walsh (@MattWalshBlog) <a href="https://twitter.com/MattWalshBlog/status/1560027417456025601?ref_src=twsrc%5Etfw">August 17, 2022</a></blockquote>
The National Cancer Institute <a class="editor-rtfLink" href="https://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet" target="_blank" rel="noopener">reports</a>, &#8220;Treatment with an LHRH agonist is called medical castration or chemical castration. But, unlike surgical castration (orchiectomy), the effects of these drugs on androgen production are reversible. Once treatment is stopped, androgen production usually resumes.&#8221;

diversity Girl standing back and holding rainbow flag on sky background

LGBTQIA+ Advocate-Pediatrician Admits Children Can Medically Transition At 10-Years-Old, Minor Females Can Have Breasts Removed

LGBTQ

Puberty blockers

Transgender

transgender surgery

<a href="http://dailywire.com/topic/big-pharma" target="_blank" rel="noopener">Pharmaceutical</a> companies have <a href="http://dailywire.com/topic/business" target="_blank" rel="noopener">lost</a> tens of billions in <a href="http://dailywire.com/topic/stock-market" target="_blank" rel="noopener">stock market</a> value this week ahead of a trial regarding the heartburn drug Zantac.
The Food and Drug Administration (FDA) <a href="https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine">announced</a> in 2019 that Zantac, the brand name for the medication ranitidine, contains low levels of a carcinogenic substance called NDMA. GlaxoSmithKline — the British pharmaceutical company that developed the drug — has been named as a defendant in approximately 3,000 personal injury cases in federal and state court, according to a <a href="https://www.gsk.com/en-gb/media/press-releases/statement-zantac-ranitidine-litigation/">press release</a> from the company.
As the first legal proceedings are scheduled for August 22, prices for shares of GlaxoSmithKline fell roughly 11.5% since Monday. Shares for Sanofi, which has also held ownership rights to the drug, were down 9.9%, while shares for Haleon, a recent spinoff from GlaxoSmithKline, were down 11.8%.
According to Barclays analyst Emily Field, no meaningful information about the upcoming litigation has been publicized. &#8220;I think the panic &#8230; really comes down to market psychology as opposed to having learned anything new,” she told <a href="https://www.reuters.com/legal/haleon-not-party-us-litigation-focused-zantac-spokesperson-2022-08-11/">Reuters</a>.
As of 2019, Zantac ranked 53 among the most frequently prescribed drugs in the United States, according to <a href="https://clincalc.com/DrugStats/Drugs/Ranitidine">ClinCalc</a>. The FDA <a href="https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac">withdrew</a> ranitidine medication from the market in 2020.
“Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” the FDA said. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”
GlaxoSmithKline, however, said in its press release that multiple motions to dismiss have been rejected by the courts despite data affirming the safety of Zantac.
“The overwhelming weight of the scientific evidence supports the conclusion that there is no increased cancer risk associated with the use of ranitidine,” the company said. “Suggestions to the contrary are therefore inconsistent with the science, and GSK will vigorously defend itself against all meritless claims alleging otherwise.”
In 2012, GlaxoSmithKline paid one of the largest health care fraud settlements in American history over failure to report safety data and the marketing of misbranded drugs, according to the <a href="https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report">Department of Justice</a>. The company marketed Paxil as a depression treatment for patients under 18 years old, even though the FDA has never approved the drug for pediatric use. The company likewise introduced Wellbutrin for weight loss, the treatment of sexual dysfunction, substance addictions, and ADHD, even though the drug had only been approved at the time for Major Depressive Disorder.
Beyond the advent of COVID vaccines and public controversies related to subsequent mandates, the pharmaceutical industry has been <a href="https://www.dailywire.com/news/many-key-pharmaceuticals-could-be-threatened-by-supply-chain-backlogs-warns-fda">impacted</a> by worldwide supply chain issues. Last year, the FDA “asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms, and any components that may be impacted in any area of the supply chain.”
American companies have grown increasingly reliant upon pharmaceutical imports from China and India, according to the <a href="https://www.cfr.org/in-brief/coronavirus-disrupt-us-drug-supply-shortages-fda">Council on Foreign Relations</a>. As of March 2020, 80% of active pharmaceutical ingredients and 90% of generic medicines came from the two nations.

Gavel

Big Pharma Stocks Plummet Amid Legal Issues Over Key Medication

Big Pharma

Business

Stock Market

The maker of Banana Boat sunscreen <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/edgewell-personal-care-issues-voluntary-nationwide-recall-banana-boat-hair-scalp-sunscreen-due">announced</a> on Friday it has voluntarily recalled three batches of its Hair &amp; Scalp Sunscreen Spray SPF 30 after finding some samples of the product contained trace levels of a cancer-causing chemical.
Edgewell Personal Care Company, which submitted the announcement to the U.S. Food and Drug Administration, said an internal review reported that some product samples contained a human carcinogen known as benzene. The batches were set to expire in December 2022, February 2023, and April 2024.
&#8220;Importantly, no other batches of Hair &amp; Scalp (either before or after the impacted production batches) and no other Banana Boat products are in the scope of this recall and may continue to be used by consumers safely and as intended,&#8221; an Edgewell spokesperson told <a class="editor-rtfLink" href="https://www.npr.org/2022/07/31/1114770333/banana-boat-sunscreen-recall" target="_blank" rel="noopener">NPR</a>. &#8220;We are conducting this voluntary recall out of an abundance of caution.&#8221;
The manufacturer said the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can. However, Edgewell officials said Banana Boat products do not contain such chemicals.
&#8220;Exposure to benzene can occur by inhalation, orally, and through the skin, and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening,&#8221; Edgewell officials said. &#8220;Benzene is ubiquitous in the environment,&#8221; the statement reads. &#8220;Humans around the world have daily exposures to it indoors and outdoors from multiple sources.&#8221; 
The Centers for Disease Control and Prevention describes benzene as a colorless or light-yellow liquid chemical at room temperature with a sweet odor and highly flammable. It evaporates quickly into the air, only slightly dissolves in water, stays afloat on top of water.
An independent health assessment from the manufacturer claims daily exposure to benzene in the recalled products would not be expected to cause adverse health consequences.
Officials said the manufacturer had not yet received any adverse events related to the recall. 
Edgewell distributed the sunscreen products nationwide through various retailers and online and has notified its base to remove any remaining recalled products from the shelves. Those who have purchased the product from the specific recalled batches are entitled to a refund.
&#8220;Consumers should stop using the affected product immediately and appropriately discard,&#8221; officials said.
Edgewell said consumers with questions regarding this recall should contact Edgewell Personal Care at 1-888-686-3988 Monday through Friday, 9 a.m. to 6 p.m. Eastern Time, or visit <a class="editor-rtfLink" href="http://www.bananaboat.com" target="_blank" rel="noopener">www.bananaboat.com</a> 
&#8220;Consumers should contact their physician or healthcare provider if they have any questions, concerns, or have experienced any problems related to using these aerosol sunscreen products,&#8221; the press release said.

Shelves of sunscreen for sale at Publix in Naples, Florida.

Banana Boat Recalls Sunscreen Product After Detecting Cancer-Causing Chemical

Recall

With the <a href="https://www.dailywire.com/topic/fda">Food and Drug Administration</a> (FDA) prepping yet another booster shot for this fall — this one to target the <a href="https://www.dailywire.com/topic/omicron">Omicron</a> variant known as BA.5 — scientists and immunologists are working on a whole new approach that includes nasal spray vaccines and body patches.
A group of scientists, doctors, and federal health officials met at the White House on Tuesday to examine new ways to battle <a href="https://www.dailywire.com/topic/covid">COVID</a>, including vaccines targeting all variants, as well as nasal sprays.
&#8220;Innovative approaches are clearly needed to induce broad and durable protection against coronaviruses known and unknown,&#8221; Dr. Anthony Fauci, the White House&#8217;s chief medical adviser and the top U.S. immunologist, told the gathering.
There&#8217;s broad consensus that despite the benefit of the currently available vaccines, the &#8220;job is not done,&#8221; Fauci said.
One innovative approach is a spray that people would shoot into their sinuses. Another is a small patch, similar to a nicotine patch used by smokers trying to quit, that would inject the vaccine via microneedles.
NBC News <a href="https://www.nbcnews.com/health/health-news/nasal-vaccines-latest-research-nasal-vaccines-covid-rcna38820">reported</a> this week that nasal vaccines &#8220;have the potential to prevent infections entirely&#8221; because they raise immunity exactly where the virus enters the body.
The nasal vaccines “concentrate the immune protection in the upper airway,” Fauci told NBC News. That means the “antibodies that are trying to protect you from having the virus enter your body, are right there on the front lines protecting you.”
“A traditional shot in the arm, you get what’s called systemic immunity, namely antibodies build up that are essentially distributed in different organs of the body,” Fauci said. That, he noted, is why people who contract the virus now after being vaccinated — including Fauci himself — have far less severe symptoms.
The nasal vaccine would work as a booster after original shots of the full vaccine.
But the nasal vaccine won&#8217;t be available for at least two years, according to Fauci. Scientists are now testing a modified version of a virus that usually infects birds to attack the virus, and it has already been found to generate immune responses in mice.
Top U.S. health officials are now <a href="https://www.dailywire.com/news/with-omicron-variant-ba-5-spreading-white-house-urges-americans-to-get-covid-boosters">recommending</a> another booster shot for most Americans, and a panel that advises the FDA is <a href="https://www.dailywire.com/news/fda-panel-recommends-new-covid-19-shots-to-target-omicron-variant">working</a> on a new one that could be released this fall that would target the Omicron variant and its subvariants, including BA.5.
Joseph Curl has covered politics for 35 years, including 12 years as White House correspondent for a national newspaper. He was also the a.m. editor of the Drudge Report for four years. Send tips to josephcurl@dailywire.com and follow him on Twitter @josephcurl.

Nasal Spray

No More Shots? Future Of COVID Vaccines Might Just Be Nasal Sprays, Patches

No More Shots? Future Of COVID-19 Vaccines Might Just Be Nasal Sprays, Patches

Medical

Pandemic

Puberty blockers, known as gonadotropin-releasing hormone (GnRH) substances, received a warning from U.S. <a href="https://www.dailywire.com/topic/fda">Food and Drug Administration</a> (FDA) officials earlier this month, saying the drug could cause brain swelling, loss of vision, and serious risks for children injecting the hormone.
Officials said a plausible association between using puberty blockers and pseudotumor cerebri, which displays symptoms similar to a brain tumor, was identified in six young girls between the ages of 5 and 12.
&#8220;Five were undergoing treatment for central precocious puberty and one for transgender care,&#8221; FDA officials <a href="https://publications.aap.org/aapnews/news/20636/Risk-of-pseudotumor-cerebri-added-to-labeling-for?autologincheck=redirected">report</a>. &#8220;The onset of pseudotumor cerebri symptoms ranged from three to 240 days after GnRH agonist initiation.&#8221;
Such symptoms in the patients included visual disturbances, headaches, and vomiting. Other effects GnRH agonists caused were an increase in blood pressure, brain swelling, and abducens neuropathy.
A spokesperson from the FDA told <a href="https://www.formularywatch.com/view/fda-updates-safety-labels-for-group-of-gnrh-agonists">Formulary Watch</a> the cases were considered clinically serious and determined that a warning should be added to all GnRH agonist products approved for pediatric patients.
&#8220;Although the mechanism by which GnRH agonists may lead to development of pseudotumor cerebri has not been elucidated, and patients with CPP may have a higher baseline risk of developing pseudotumor cerebri compared with children without CPP,&#8221; the spokesperson said. &#8220;This potential serious risk associated with GnRH agonists justifies inclusion in product labeling.&#8221;
Puberty blockers and hormones have come under fire again after President Joe Biden&#8217;s U.S. Assistant Secretary of Health Rachel Levine asserted that the U.S. should not limit youth access to so-called &#8220;gender-affirming care.&#8221;
&#8220;Gender affirming care is life-saving, medically necessary, age-appropriate, and a critical tool for health care providers,&#8221; Levine <a href="https://www.youtube.com/watch?v=EY0VNzkLHTI&amp;t=20s">said</a>. &#8220;As a pediatrician, when it comes to making sure kids are healthy and happy, I know how important care that affirms someone&#8217;s true identity can be.&#8221;
However, Florida&#8217;s Department of Health has argued the opposite of Levine&#8217;s claims, saying that due to the lack of conclusive evidence, and the potential for long-term and irreversible effects, doctors should not prescribe children 18 years old and younger puberty blockers or hormone therapy.
&#8220;Based on the currently available evidence &#8216;encouraging mastectomy, ovariectomy, uterine extirpation, penile disablement, tracheal shave, the prescription of hormones which are out of line with the genetic make-up of the child, or puberty blockers, are all clinical practices which run an unacceptably high risk of doing harm,'&#8221; Florida&#8217;s Department of Health wrote in a <a href="https://www.floridahealth.gov/_documents/newsroom/press-releases/2022/04/20220420-gender-dysphoria-guidance.pdf?utm_source=floridahealth.gov&amp;utm_medium=referral&amp;utm_campaign=newsroom&amp;utm_content=article&amp;url_trace_7f2r5y6=https://www.floridahealth.gov/newsroom/2022/04/20220420-gender-dysphoria-press-release.pr.html">memo</a>.
Yet Levine claims every major medical association agrees with the comments about “gender-affirming” care saving lives, according to <a href="https://www.foxnews.com/us/florida-dept-health-slams-rachel-levine-character-assassination-trans-youth-comments">Fox News</a>.
Jeremy Redfern, a Florida Health Department spokesperson, denounced Levine&#8217;s so-called data.
&#8220;It&#8217;s an appeal to authority that is in stark contrast to the best available evidence,&#8221; Redfern said.
He said while the state&#8217;s Health Department is following the evidence, the federal government is following the eminence.

Gloved Hand holding a Syringe

FDA Officials Warn Of Brain Swelling, Vision Loss In Minors Using Puberty Blockers

Rachel Levine

The <a href="https://www.dailywire.com/topic/biden-administration">Biden administration</a> is touting its latest shipment of <a href="https://www.dailywire.com/topic/baby-formula">baby formula</a> from overseas as evidence that the nationwide shortage is improving, but a look at the details shows that the crisis could go on for months.
On Monday, President Joe Biden <a href="https://townhall.com/tipsheet/katiepavlich/2022/07/18/biden-is-still-importing-baby-formula-from-overseas-as-crisis-continues-to-rage-n2610388">announced</a> that Switzerland was importing thousands of cases of baby formula to help stock stores in the <a href="https://www.dailywire.com/topic/united-states">United States</a>. The delivery was the 17th shipment from abroad, but the latest data show that the shelves are still missing critical items needed to keep babies satiated.
&#8220;Today, President Biden is announcing that his Administration is sourcing two flights, facilitated by the U.S. Department of Health and Human Services (HHS), for Operation Fly Formula to transport Nestlé Health Science amino acid-based formula from Switzerland to John F. Kennedy Airport in New York on July 21 and 22,&#8221; The White House <a href="https://townhall.com/tipsheet/katiepavlich/2022/07/18/biden-is-still-importing-baby-formula-from-overseas-as-crisis-continues-to-rage-n2610388">said</a> in a <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/07/18/president-biden-announces-seventeenth-operation-fly-formula-mission/">press release</a>.
&#8220;This delivery will include approximately 74,403 pounds of Nestlé Health Science Alfamino® Infant and Alfamino® Junior formula, the equivalent of 802,446 8-ounce bottles. These products will be distributed primarily to hospitals and home health care providers,&#8221; the administration said.
Despite Biden insisting that Operation Fly Formula is a success, The New York Post <a href="https://nypost.com/2022/07/18/baby-formula-shortage-getting-worse-despite-biden-airlifts/">reported</a> that the market research firm IRI shows that 28.3% of powdered baby formula products were out of stock at U.S. stores for the week ending July 10. That is more than the 23.7% reported out of stock for the week ending May 22, the paper noted.
Joseph Antos, a senior fellow at the American Enterprise Institute, told The Post that Biden&#8217;s press release on Monday was emblematic of the administration fundamentally misunderstanding the problem. Antos argued that regulations crafted by the Food and Drug Administration (FDA) are hampering the ability to restock the shelves.
&#8220;This idea that some publicist in the White House came up with was really meant to impress people with the administration’s concern,” Antos told the paper. “But it’s pretty much a drop in the bucket compared to what would normally be imported if we had regular imports of baby formula from anywhere else. We don’t … because there is a very large tariff barrier … [and] the other factor, of course, is FDA rules. FDA really makes it very difficult.”
In early July, an anonymous Health and Human Services official reportedly <a href="https://www.politico.com/news/2022/07/09/abbott-plant-at-center-of-shortages-quietly-restarted-july-1-00044840">told</a> Politico, &#8220;We are months — months — away from an end to these shortages,&#8221; while <a href="https://www.politico.com/news/2022/07/09/abbott-plant-at-center-of-shortages-quietly-restarted-july-1-00044840">acknowledging</a> that the Biden administration&#8217;s shipments of baby formula are often only temporary measures and provide barely enough formula for a few days in the U.S. — let alone an entire week or month.
Meanwhile, White House Press Secretary Karine Jean-Pierre <a href="https://www.wsj.com/amp/articles/baby-formula-shortage-deepens-defying-replenishment-efforts-11657796400">told</a> reporters on Monday, &#8220;Look, this is a priority, it continues to be a priority for us.&#8221;
&#8220;We’re going to do everything that we can to increase production. But, again, we want to make sure that the safety is first,&#8221; she added in reference to the reopening of the Abbott baby formula plant in Sturgis, Michigan.

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FDA