The Food and Drug Administration finally banned Red Dye No. 3 for food, drinks, and dietary supplements on Wednesday. The synthetic dye is linked to cancer in animals and is already prohibited in many European countries along with Australia and Japan. The real question here is what took the FDA so long, or a better question, why now? 
The FDA’s move comes just before the Trump administration and the “Make America Healthy Again” movement take control in a few days. MAHA enthusiasts are ecstatic about the Red Dye No. 3 ban and what it could mean going forward as Health and Human Services Secretary nominee Robert F. Kennedy Jr. has hinted at banning other artificial dyes. 
Unlike some vitamin companies, at <a href="https://responsibleman.com/" target="_blank" rel="noopener">ResponsibleMan</a>, we’re highly intentional about what we’re putting in our multivitamins, and we keep all artificial dyes out of our products. The <a href="https://responsibleman.com/products/resilience-premium-mens-multivitamin?selling_plan=1143570497" target="_blank" rel="noopener">Emerson Multivitamin</a>, for instance, is packed with 13 core vitamins, 19 hand-selected nutrients and antioxidants, and zero artificial dyes. 
Following the FDA’s ruling, manufacturers that use Red Dye No. 3 in thousands of foods and drinks will have until January 2027 to remove the dye while dietary supplement manufacturers will have until 2028 to remove it. Until then, you have a choice to make. You can keep getting your multivitamins from big, soulless multinational corporations that care more about pleasing their shareholders than your health — companies that might be perfectly fine keeping Red Dye No. 3 in their supplements for three more years. Or you can switch to ResponsibleMan, a company that you know and can trust and has always refused to use any artificial dyes.
The <a href="https://responsibleman.com/products/resilience-premium-mens-multivitamin?selling_plan=1143570497" target="_blank" rel="noopener">Emerson Multivitamin</a> from ResponsibleMan is a physician-formulated, robust supplement made up of 33 key premium ingredients that helps fill nutrient gaps to support your immune system, maintain energy production, sharpen brain cognition, and support the health of your heart and muscles.​​ You can sign up now and <a href="https://responsibleman.com/products/resilience-premium-mens-multivitamin?selling_plan=1143570497" target="_blank" rel="noopener">save 50% off your Emmerson vitamins today!</a>
ResponsibleMan was started by The Daily Wire in partnership with the guys over at Legacybox because men’s health products suck. Health product companies either try to <a href="https://www.dailywire.com/news/vitamin-company-goes-woke-makes-special-labels-for-people-who-go-by-they-them" target="_blank" rel="noopener">sell you leftism</a> or inject artificial dyes into their dietary supplements. But it’s a new world. Leftism and artificial dyes are getting the boot, and true manliness and healthy living are here to stay. 
The MAHA era has arrived, and thankfully, there’s already a <a href="https://responsibleman.com/products/resilience-premium-mens-multivitamin?selling_plan=1143570497" target="_blank" rel="noopener">multivitamin</a> to go with it.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
ResponsibleMan shares common ownership with The Daily Wire.

Red Dye

No Artificial Dyes Here: Ahead Of The MAHA Curve

Health

The Food and Drug Administration (FDA) announced on Wednesday that Red Dye No. 3, a synthetic dye linked to cancer in animals, will be banned in food and drinks in the U.S.
Red Dye No. 3 is used in thousands of foods, such as cereal and candy, and drinks, such as carbonated beverages and cocktails. Manufacturers will have until January 15, 2027, to modify food and beverage products and remove Red Dye No. 3, while companies that produce dietary supplements will have until January 15, 2028, NBC News <a href="https://www.nbcnews.com/health/health-news/fda-bans-red-no-3-artificial-coloring-beverages-candy-rcna185479" target="_blank" rel="noopener">reported</a>.
The dye, made from petroleum and approved for use in foods in 1907, has been banned in Australia, Japan, and many European countries. The U.S. also banned Red Dye No. 3 in cosmetics in 1990 after a study conducted in the 1980s showed that rats exposed to Red Dye No. 3 in high doses developed tumors. Some food and drink manufacturers have already begun removing Red Dye No. 3, among other dyes, according to NBC News.
&#8220;The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals,&#8221; said Jim Jones, the FDA&#8217;s deputy director for human foods. &#8220;Evidence shows cancer in laboratory male rats exposed to high levels of FD&amp;C Red No. 3.&#8221;
The FDA&#8217;s move to ban Red Dye No. 3 comes less than a week before the Trump administration takes over. Health and Human Services Secretary nominee Robert F. Kennedy Jr. has vowed to pressure large companies to remove dyes from foods.
“The first thing I’d do isn’t going to cost you anything because I’m just gonna tell the cereal companies, take all the dyes out of their food,” Kennedy <a href="https://www.bloomberg.com/news/articles/2024-11-04/kellogg-general-mills-face-pressure-to-ban-artificial-food-dyes" target="_blank" rel="noopener">said</a> while campaigning for Trump.
Kennedy, who has promised to &#8220;Make America Healthy Again,&#8221; needs to be confirmed by the Senate. His confirmation hearing date has not been announced.
<a href="https://get.dailywire.com/subscribe/plus/?_gl=1*1lail3r*_gcl_aw*R0NMLjE3MzIyMDEyNDkuQ2owS0NRaUEwZnU1QmhEUUFSSXNBTVhVQk9JSkM0VnNsMFVreURxYXUxVWVEVWdOdjZkNzR2Y1pEeEZQeHVBcGl2R3BLaTdBMjVzT1p5TWFBdG1nRUFMd193Y0I.*_gcl_au*NDUxNDQ0NzYwLjE3MzY3ODI2NDY.*_ga*MTc2NzM0NDQ2NS4xNzI4OTA5Nzkx*_ga_CZKR9ZYKJP*MTczNjk1NzYwMy4zNDAuMS4xNzM2OTU3NzE2LjYwLjAuMA.." target="_blank" rel="noopener">CELEBRATE #47 WITH 47% OFF DAILYWIRE+ MEMBERSHIPS + A FREE $20 GIFT</a>
Kennedy&#8217;s comments on food dyes suggest the incoming Trump administration would go beyond merely banning Red Dye No. 3 and also prevent other dyes, such as Red 40 and Blue 1, from being used in food and drinks in the U.S. Last year, California Democratic Gov. Gavin Newsom signed a law banning six dyes from food that is served at public schools in the state, Bloomberg <a href="https://www.bloomberg.com/news/articles/2024-11-04/kellogg-general-mills-face-pressure-to-ban-artificial-food-dyes" target="_blank" rel="noopener">reported</a>. A <a href="https://publichealth.berkeley.edu/news-media/research-highlights/new-report-shows-artificial-food-coloring-causes-hyperactivity-in-some-kids" target="_blank" rel="noopener">report</a> released by California in 2021 showed that &#8220;consumption of synthetic food dyes can cause hyperactivity and other neurobehavioral issues for some children.&#8221;
Food safety advocates applauded the FDA&#8217;s decision on Wednesday, but some said the ban should have come much sooner. Dr. Peter Lurie, president of the Center for Science in the Public Interest, told NBC News that the decision &#8220;removes an unnecessary hazard from the American food supply, and we welcome that action, even though it should have occurred more than three decades ago.&#8221;

Strawberry Berry Soft Drink

FDA Bans Controversial Dye Found In Thousands Of Foods

Federal Government

Food

General

Robert F. Kennedy Jr.

MixCollage-25-Mar-2024-02-58-PM-950

How A Leftist Network Of Websites Floods Red States With Abortion Pills With No Consequences

Abortion

Supreme Court

The Food and Drug Administration (<a href="https://www.dailywire.com/topic/fda">FDA</a>) is reviewing a petition to ban red dye No. 3, a common additive in beverages, <a href="https://www.dailywire.com/topic/food">snacks</a>, cereals, and candies.
Jim Jones, the FDA’s deputy commissioner for human foods, said it’s time to reevaluate the department’s determination that the artificial coloring is safe for human consumption as more than a decade has passed since that decision was made.
“With red 3, we have a petition in front of us to revoke the authorization board, and we’re hopeful that in the next few weeks, we’ll be acting on that petition,” Jones told a health committee last Thursday, per <a href="https://www.usatoday.com/story/news/health/2024/12/09/fda-red-food-dye-3-ban/76857859007/">USA Today</a>.
House Energy and Commerce Committee ranking member Frank Pallone Jr. (D-NJ) said he supported a ban on red dye No. 3. The dye is made from petroleum and is used to give food and drinks a bright red hue. One argument against its use is that it is solely used for marketing purposes and provides no nutritional value. 
“With the holiday season in full swing where sweet treats are abundant, it is frightening that this chemical remains hidden in these foods that we and our children are eating,” Pallone wrote in a letter. “While food companies must ensure that the food they market is safe, they are also only required to ensure that their products meet FDA’s standards. This means that thousands of products that contain this chemical can remain on the market.” 
The outlet noted that red dye No. 3 has been linked to hyperactivity in children and has been found to cause cancer in animals. To date, no study has made a connection between consumption of the artificial dye and cancer in humans. 
Robert F. Kennedy Jr., President-elect Donald Trump’s pick for health secretary, has stated his belief that food dyes cause cancer, but has not voiced his opinion on the current petition or laid out a plan for banning specific dyes.  
“There are some departments such as the nutrition departments in the FDA that have to go, that are not doing their job, they are not protecting our kids,” RFK Jr. told <a href="https://www.msnbc.com/rachel-maddow-show/maddowblog/rfk-jr-starts-fleshing-vision-trumps-second-term-rcna179000">NBC News</a> last month. &#8220;Why do we have Fruit Loops in this country that have 18 or 19 ingredients and you go to Canada and it&#8217;s got two or three?&#8221; he said.
Red dye No. 3 has been banned from cosmetics in the U.S. since 1990. The additive is already banned in the European Union, and beginning in January 2027, it will also be prohibited in foods sold or manufactured in California.

Candy

FDA Reviews Petition To Ban Red Food Dye

U.S.

President-elect <a href="https://www.dailywire.com/topic/donald-trump" target="_blank" rel="noopener">Donald Trump</a> announced late this week that he has selected Marty Makary MD, MPH, FACS, to lead the Food and Drug Administration (FDA).
&#8220;FDA has lost the trust of Americans, and has lost sight of its primary goal as a regulator,&#8221; Trump said in a statement. &#8220;The Agency needs Dr. Marty Makary, a Highly Respected Johns Hopkins Surgical Oncologist and Health Policy Expert, to course-correct and refocus the Agency.&#8221;
Trump noted that Makary will work under the leadership of Trump&#8217;s nominee for HHS Secretary, Robert F. Kennedy Jr., to &#8220;properly evaluate harmful chemicals poisoning our Nation’s food supply and drugs and biologics being given to our Nation’s youth, so that we can finally address the Childhood Chronic Disease Epidemic.&#8221;
Trump&#8217;s nomination of Makary comes at the same time that he announced he was nominating <a href="https://www.dailywire.com/news/trump-taps-dr-janette-nesheiwat-for-u-s-surgeon-general" target="_blank" rel="noopener">Dr. Janette Nesheiwat</a> to serve as the next U.S. Surgeon General and former <a href="https://www.dailywire.com/news/trump-names-former-florida-congressman-cdc-director" target="_blank" rel="noopener">Rep. Dave Weldon (R-FL)</a>, who is a medical doctor, to be the next Director of the Centers for Disease Control and Prevention (CDC).
Trump said that Makary has been a pioneer in the fields of public health, cancer care, and surgery.
<a href="https://get.dailywire.com/gift-guide/" target="_blank" rel="noopener">CHECK OUT THE DAILY WIRE HOLIDAY GIFT GUIDE</a>
&#8220;A member of the prestigious National Academy of Medicine, Dr. Makary has devoted his career to improving Medical Quality and lowering Hospital and Drug Costs for all Americans,&#8221; Trump said. &#8220;In addition, Dr. Makary is an accomplished Professor at the Johns Hopkins School of Medicine and Johns Hopkins Carey Business School, and a leading advocate for Healthcare Transparency.&#8221;
&#8220;He is the recipient of the Nobility in Science Award from the National Pancreas Foundation and numerous teaching awards,&#8221; he continued. &#8220;Dr. Makary currently leads the Evidence-Based Medicine and Public Policy Research Group at Johns Hopkins.&#8221;
Related: <a href="https://www.dailywire.com/news/trump-taps-billionaire-hedge-fund-manager-scott-bessent-for-treasury-secretary">Trump Taps Billionaire Hedge Fund Manager Scott Bessent For Treasury Secretary</a>

A Special Screening Of The HBO Documentary Film ‘Bleed Out’

Trump Names Marty Makary To Lead Food And Drug Administration

Donald Trump

Executive

Politics

Trump Administration

Retail giant <a href="https://www.dailywire.com/topic/costco">Costco</a> has recalled close to 80,000 pounds of <a href="https://www.dailywire.com/topic/food">butter</a> due to an error on the packaging.
The FDA sent out an initial recall for 79,200 pounds of both unsalted and salted Kirkland Signature Sweet Cream Butter in October due to the label failing to say the product “contains milk.”  Packages for both variations include “cream” on the ingredients list, but that was not enough to avoid a recall. Costco created the Kirkland Signature line in 1995.
On November 7, the FDA classified the recall as Class II, which is &#8220;a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,&#8221; per the administration’s <a href="https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions">website</a>.
Reactions on social media were filled with mockery.
“80,000 pounds of Costco butter was just recalled, because the label doesn’t say that it contains milk. It’s butter. News articles are telling people how they can return, or safely dispose of, the butter. It’s butter,” one popular X reaction <a href="https://x.com/RealSpikeCohen/status/1855830188594012492">said</a>. 
<a href="https://www.amiracist.com/?_gl=1*jtghwp*_gcl_au*ODQ1NjYzNTg2LjE3Mjg5MDk3OTE.*_ga*MTc2NzM0NDQ2NS4xNzI4OTA5Nzkx*_ga_CZKR9ZYKJP*MTczMDEyMDgwOS40OS4xLjE3MzAxMjA4MzkuMzAuMC4w">MATT WALSH’S ‘AM I RACIST?’ NOW STREAMING ON DAILYWIRE+</a>
Another commenter <a href="https://x.com/cactusncookies/status/1855848231097295356">quipped</a>, “Can y’all please safely dispose of it at my house? I have a lot of holiday baking to do.”
“But if the butter is mislabeled, consumers would literally be spreading misinformation—all over their toast, bagels, pancakes, baked potatoes, muffins—it’s too horrific to think about,” another joking response <a href="https://x.com/utterboor/status/1855840676526629189">said</a>.
Despite all the mockery, some social media users agreed with the recall. 
“The laws exist to make sure that any food that contains a recognized allergen is labeled as such. Yeah in this case it seems silly, but how do you codify ‘you must label food that contains allergens, unless posters on Twitter decide that it&#8217;s obvious enough on its own’?” one person <a href="https://x.com/tempestis/status/1856031369014718469">wrote</a>.
The Centers for Disease Control (CDC) lists milk as one of the main foods that &#8220;account for most serious allergic reactions in the United States.&#8221;

Costco

Costco Recalls 80,000 Pounds Of Butter. You’ll Never Guess Why.

Costco Recalls 80,000 Pounds Of Butter. You'll Never Guess Why.

Business

Recall

United States

Ever since the U.S. Food and Drug Administration removed basic safeguards on high-risk abortion drugs, women have been suffering. Many women who take these drugs are told to expect mild pain, only to be shocked by the excruciating experience of an at-home abortion — without any in-person care or visits with a doctor to let them know when emergency care is necessary. Women deserve better.
Unfortunately, women will continue to be harmed by what the FDA has done, for now. On June 13, the Supreme Court declined to address the merits of a <a href="https://adflegal.org/case/us-food-and-drug-administration-v-alliance-hippocratic-medicine?utm_source=dailywire&amp;utm_medium=oped" target="_blank" rel="noopener">case</a> brought against the FDA over its removal of basic protections for women taking abortion drugs.
My organization, Alliance Defending Freedom, represented frontline doctors who are witnessing firsthand the harms inflicted by the FDA’s reckless removal of commonsense protections, like in-person visits to check for ectopic pregnancies. While it’s disappointing that the Supreme Court’s decision didn’t address the FDA’s reckless actions and that women will continue to suffer, we are grateful that three states stand ready to hold the FDA accountable, since they are not precluded from moving forward with litigation.
That accountability is important because, when the FDA first approved abortion drugs in 2000, it required doctors to provide ongoing care to women using the drugs, including in-person visits to check for ectopic pregnancies, severe bleeding, and life-threatening infections. Yet in a pair of highly politicized decisions—first in 2016, then in 2021—the FDA endangered women’s health by stripping away those requirements for in-person care. Indeed, data the FDA cites shows that hospitalizations increase over 300% with no in-person doctor visit.
But putting the abortion industry’s bottom line over women’s health, the FDA has left women to perform their own abortions at home or in their dorm rooms without critical medical attention and relying on emergency-room doctors, like those we represent, to care for anticipated complications.
Abortion drugs are not safe. The FDA’s own label has long warned that roughly one out of 25 women who take them will end up in the ER, and documents show that 7% will require surgery. But the FDA removed its original safeguards anyway. Thus, since the removal of these safeguards, our doctors have seen a huge surge in women experiencing complications and needing their care. That was no shock to the FDA, which acknowledged that women harmed by these drugs would need to rely on emergency rooms instead of the prescribers who gave them the drugs, despite how overwhelmed emergency rooms already are.
In a telling moment at oral argument before the Supreme Court, the abortion drug manufacturer Danco admitted that its primary interest in this case was its profits. When Justice Samuel Alito asked Danco’s attorney to explain what injury the company would suffer if the FDA’s original safeguards were re-applied, she answered, “We are prevented from selling our product.” So much for caring about women’s health.
Both the federal district court and the circuit court agreed with us that the FDA should be held accountable for endangering women’s health. Women who had suffered from the FDA’s recklessness felt they were finally heard and hoped the FDA would do its job so no more women experience the excruciating pain and isolation of an at-home abortion. But, at oral argument, the U.S. solicitor general concerningly claimed that nobody, not even the frontline doctors who treat and care for women harmed by abortion drugs, can challenge the FDA’s removal of common-sense protections.
While the FDA managed to avoid accountability on a legal technicality in this case, the states of Missouri, Kansas, and Idaho are ready to step in to hold the FDA accountable for jeopardizing the health and safety of women and girls. No federal agency is above the law, and women deserve the in-person care of a doctor when taking high-risk drugs.
So, while the agency may have gotten away with endangering women’s health for now, this lawsuit backed the federal government into a corner. The government’s initial position was that federal law would not protect our doctors from being forced to participate in abortions. But, at the Supreme Court, the government changed its position and said that federal conscience laws protect doctors in these circumstances. And the court agreed, emphatically stating in its 9-0 decision that “[f]ederal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences.”
It&#8217;s encouraging that the court broadly affirmed conscience rights for medical professionals. But that doesn’t change the fact that the agency’s removal of commonsense safeguards for women using abortion drugs is as wrong today as it was before. ADF and the doctors and medical associations in this case will continue to stand for women’s health and expose the reckless actions of the FDA while the states continue their fight in the lower courts.
* * *
Gabriella McIntyre is legal counsel with <a href="http://www.adflegal.org/?utm_source=dailywire&amp;utm_medium=oped" target="_blank" rel="noopener">Alliance Defending Freedom</a> (<a href="https://twitter.com/ADFLegal" target="_blank" rel="noopener">@ADFLegal</a>), which represents four doctors and four medical associations in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine.
The views expressed in this piece are those of the author and do not necessarily represent those of The Daily Wire.

Supreme Court Keeps Full Access to Widely Used Abortion Pill

FDA Left Unaccountable For Abortion Drug Harms

Abortion Drug

Alliance Defending Freedom (ADF)

Opinion

SCOTUS

Women

On April 24th, a team of FDA-supported scientists published a new study in <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2818033" target="_blank" rel="noopener">JAMA Pediatrics</a> investigating serious adverse events associated with mRNA vaccines in children.
This comprehensive and well-constructed cohort study focused on post-market surveillance of the COVID vaccines in over 4 million children, confirming the well-documented risk of myocarditis — inflammation of the heart muscle — in adolescents 12-17 who take the mRNA COVID vaccines.
However, the most shocking finding was the discovery of a new safety signal which hadn&#8217;t been reported before:
<blockquote>&#8220;In the primary analysis, seizure met the statistical threshold for a signal in children aged 2 to 4 years after BNT162b2 vaccination in all 3 databases and in children aged 2 to 5 years after mRNA-1273 vaccination in 2 of the 3 databases.&#8221;</blockquote>
In other words, the study authors found a statistically significant signal of seizures in children aged 2 to 4 years after the Pfizer vaccine and children 2 to 5 years after the Moderna vaccine.
&#8220;The statistical signal for seizure in children aged 2 to 4 or 5 years has not been previously reported for this age group in active surveillance studies of mRNA COVID-19 vaccines,&#8221; the study states.
More specifically, the study finds a significantly elevated risk of seizures after doses one and two of the Pfizer vaccine in kids ages 2 to 4 and dose two of the Moderna vaccine for kids ages 2 to 5. It&#8217;s worth noting, if this finding was merely incidental and unrelated, it wouldn&#8217;t have been found for both mRNA vaccines. Moreover, the scientists note they couldn&#8217;t identify any &#8220;data quality concerns&#8221; that would compromise or bias the results.
The true scale of seizures caused by mRNA vaccines in kids across the United States (and other countries) is unclear, but it is likely quite concerning.
<h3>1 In 5,000 Risk Of Seizures In Kids Following Vaccination</h3>
To be clear, the absolute number of seizures caused is not alarmingly high. According to the limited data, the rate of vaccine-related seizures in young kids is approximately 1 in 5,000. Put differently, .02% of mRNA-injected kids developed seizures in the first couple of weeks following vaccination.
While it is true this is an extremely small absolute figure, critics are wrong to view such risks as &#8220;rare&#8221; and trivial because the vaccine does not confer any significant benefit in young kids to outweigh such risks. In other words, compared to the extremely low risk of COVID in young children, even a very small number of seizures would sway the risk-benefit analysis towards not getting vaccinated.
The study identifies 72 seizures in kids following vaccination. What benefit did those kids seek to attain? They had a survival rate of more than <a href="https://www.medrxiv.org/content/10.1101/2022.10.11.22280963v1" target="_blank" rel="noopener">99.9997%</a> (this statistic is for ages 0 to 19, not 2 to 5 which the seizure signal has appeared in. The survival rate in younger groups would be far higher.)
As my colleague Jay Bhattacharya elaborated, &#8220;the benefits are likely to be small in these groups since nearly 100% of individuals in these groups have already had covid and recovered.&#8221; &#8220;Such recovered immunity provides stronger protection against severe disease on reinfection than the vaccine,&#8221; he added.
&#8220;Even for the first infection, the risk of death from covid infection for adolescents and toddlers is incredibly low,&#8221; he explained.
Yet, the study bizarrely states that &#8220;The US Food and Drug Administration concludes that the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks of COVID-19 infection.&#8221;
How does that make sense when the study itself does not conduct any assessment of the health benefits and harms of the COVID vaccine for toddlers or adolescents?
<h3>My Correspondence With The FDA</h3>
Stunned by the incongruous conclusion of the study, I decided to contact the FDA to ask them how they continue to support COVID vaccination in children absent any supportive risk-reward analyses. I ended up getting in touch with an FDA spokesperson.
To their credit, they decided to engage with me on this contentious topic. I did not expect that. Here was their response to my question on unproven COVID vaccine safety in children: 
<blockquote>&#8220;The focus of this manuscript was the safety of the Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 vaccines in U.S. children aged 6 Months to 17 years, so we focused on the fact that the vaccine was safe.&#8221;</blockquote>
Wait, what?
I had to read this over a couple of times because I was so perplexed by this sentence.
The explicitly stated objective of the study was &#8220;To conduct near-real-time monitoring of health outcomes after COVID-19 vaccination in the US pediatric population.&#8221;
As a result, they decided to focus on the opinion, not &#8220;fact,&#8221; that &#8220;the vaccine was safe&#8221;?
This is essentially like saying, &#8220;The focus of our work was to clean the house so we focused on the fact that the house was clean.&#8221; Unless I&#8217;m tripping, my BS meter was already ringing. Only to make matters worse, they went on to say:
<blockquote>&#8220;The benefits of the vaccine have been reported elsewhere, which include, but are not limited to the reduced incidence of medically diagnosed and hospital and emergency department diagnosed COVID-19, as reported here: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11047006/">Effectiveness of BNT162b2 COVID-19 primary series vaccination in children aged 5–17 years in the United States: a cohort study &#8211; PMC (nih.gov)</a>.&#8221;</blockquote>
This cited study has numerous issues. For one, the study population is 5 to 17-year-olds, not 2 to 5-year-olds which is the cohort for whom the risk of seizures was found. So how can the FDA use this as their primary evidentiary source to support vaccination in young kids?
Moreover, the cited study on vaccine effectiveness in children aged 5 &#8211; 17 may be severely compromised by incidental COVID cases. A number of estimates <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11027788/" target="_blank" rel="noopener">have shown</a> that 40 &#8211; 60% of COVID hospitalizations are incidental (the cause of the hospitalization was unrelated to the positive COVID test result).
Dr. Tracy Beth Hoeg, epidemiologist and vaccine myocarditis researcher, stated, &#8220;Even for that tiny numerical difference in rates most of those are probably incidental hospitalizations and so the chance to benefit is so small and could easily all be explained by transient healthy vaccine effect mostly attributable to hospitalization with and not for covid.&#8221;
&#8220;We would have needed a very large randomized study among children to know what the real effect, if any, of the vaccine was. I would not rely on the results of this study,&#8221; she added.
I emailed back the FDA, highlighting these concerns, and they took a few days because the spokesperson was working on the response (I followed up a couple of times). I thought they were going to address my concerns point by point with honest transparency.
Well, they fooled me.
I got an email back from the FDA with the most frustratingly cookie-cutter, generic response possible:
<blockquote>“The FDA is confident in the safety and effectiveness of the COVID-19 vaccines approved or authorized for use in the U.S. The vaccines’ benefit-risk profiles are well understood and demonstrate that the known and potential benefits for individuals 6 months of age and older outweigh their risks.
With over a billion doses administered, we have data from real-world use of these vaccines demonstrating that the benefits of getting vaccinated, which include a clear reduction in hospitalization and death, outweigh potential risks.
Further information related to the FDA’s conclusions regarding benefit-risk assessment can be found within the respective decision and review memoranda available on FDA’s website here.”</blockquote>
And that&#8217;s that.
This is an illustrative, real-time example of what I told Russell Brand once &#8220;when the narrative trumps the facts.&#8221; They initially engaged with me, seemingly in earnest, but we came to a point where I was questioning the unquestionable. I collided with the sacred orthodoxy of &#8220;vaccines are safe and effective for kids&#8221; driven by a toxic cocktail of political, financial, pharmaceutical, and quasi-scientific institutional interests.
The plain reality is COVID vaccines were never necessary or proven to be safe and effective to administer in children on a mass scale.
Even the most zealous mRNA advocates admitted, when faced with pediatric vaccine hesitancy, that the primary purpose of vaccinating young kids was to protect adults and the elderly.
This was a fundamental error from the start because dosing kids with the mRNAs was nothing as safe as dosing them with apple sauce or vitamin D. There were serious safety concerns from the start, some substantiated by the data and others unclear, but the FDA and the CDC should have never mass-recommended the COVID vaccines as an urgent, essential intervention for children who had a near-zero infection fatality rate.
The true scale of harm from seizures and other serious adverse events is unknown. As Johns Hopkins researcher Dr. Marty Makary once said, &#8220;A baby can&#8217;t tell you they have myocarditis&#8221; (let alone subclinical myocarditis which does not produce any symptoms).
<h3>“Child Sacrifice”</h3>
Coincidentally,  Joe Rogan recently <a href="https://youtu.be/0r23Hzu6VPw" target="_blank" rel="noopener">brought up</a> the travesty of mass mRNA child vaccination in a conversation with comedian Deric Poston, and referred to it as a “child sacrifice.”
Provocative but far from hyperbolic, that is exactly how public health treated children. In the name of &#8220;protecting the elderly&#8221; or &#8220;herd immunity,&#8221; they neglected and sacrificed the health of young children, who had the least to gain and most to suffer, with the experimental mRNA shots.
As we are finding out now, the potentiality of harm that was feared by the unhinged &#8220;conspiracy theorists&#8221; (which is what I thought), is coming to bear as more and more serious side effects emerge and indict the corrupt regulatory agencies and public health authorities who pushed the shots with unwavering religious zeal.
* * *
Rav Arora is a 22-year-old journalist based in Vancouver covering free speech, Big Pharma, Covid mandates, and totalitarianism. His work has appeared on The Joe Rogan Experience, The Jordan B. Peterson Podcast, and The Ben Shapiro Show, among other major platforms. Follow his Substack newsletter with Dr. Jay Bhattacharya: <a href="https://www.illusionconsensus.com/">The Illusion Of Consensus.</a>
This article originally appeared on Substack on &#8220;<a href="https://www.illusionconsensus.com/p/new-fda-study-reports-elevated-post">Illusion of Consensus</a>.&#8221;
The views expressed in this piece are those of the author and do not necessarily represent those of The Daily Wire.

A Covid-19 Vaccination Site As Children Under 5-Years Old Become Eligible For Shot

New FDA Study Reports Elevated Post-Vaccination Seizure Risk In Toddlers

Children

COVID

Investigation

Readers Pass

Vaccines

The <a href="https://www.dailywire.com/topic/supreme-court" target="_blank" rel="noopener">Supreme Court</a> heard oral arguments on Tuesday on whether to reinstate certain <a href="https://www.dailywire.com/topic/fda" target="_blank" rel="noopener">FDA</a> restrictions on mifepristone, the drug that is used in more than half of the abortions in the United States.
The arguments come as a group of pro-life physicians, the Alliance for Hippocratic Medicine, represented by the Alliance Defending Freedom, sued the Biden administration after it lifted restrictions on the mailing and prescribing of abortion pills. The physicians say that the previous limits should be reinstated for safety reasons and that the FDA relaxed its guidelines for politicized reasons. Changes in 2016 and 2021 made mifepristone available by mail and allowed the drug to be prescribed by medical providers who are not physicians. 
“Women should have the ongoing care of a doctor when taking high-risk drugs. The FDA betrayed women and girls when it unlawfully removed the necessary in-person doctor visits that protected women’s health and well-being,” ADF lawyer Erin Hawley <a href="https://adflegal.org/press-release/us-supreme-court-hear-arguments-tuesday-about-fdas-recklessness">said</a> in a statement before arguments began. “The FDA’s own label for abortion drugs says that roughly one in 25 women who take them will end up in the emergency room. Yet the federal government continues to defend its reckless actions that jeopardize women’s health and safety.”
The case, FDA v. Alliance for Hippocratic Medicine, came to the court after the Fifth Circuit Court of Appeals <a href="https://www.dailywire.com/news/federal-appeals-court-makes-decision-on-the-mailing-of-abortion-pills" target="_blank" rel="noopener">ruled</a> in August that mifepristone should not be distributed through the mail or prescribed via telemedicine. Hawley, the wife of Sen. Josh Hawley (R-MO), is arguing for the Alliance for Hippocratic Medicine while the Biden administration is being represented by Solicitor General Elizabeth Prelogar.
During arguments on Tuesday, Prelogar argued that mifepristone was safe to prescribe online and said that the pro-life doctors challenging the FDA lacked standing. She also <a href="https://www.nytimes.com/live/2024/03/26/us/abortion-pill-supreme-court" target="_blank" rel="noopener">claimed</a> that “only an exceptionally small number of women suffer the kinds of serious complications” that pro-lifer advocates have said come with the prescription of mifepristone. 
According to data from the pro-abortion Guttmacher Institute, more than 60% of abortions in the U.S. in 2023 were done via medication. The total reported was 642,700 in the formal healthcare system, which is likely substantially less than the number of medication abortions that may have been done by women ordering from non-certified websites. 
Justice Samuel Alito pushed Prelogar on the standing issue, saying that someone should be able to challenge the FDA’s rollback of mifepristone restrictions.
As arguments began in the case, both pro-life and pro-abortion rights activists gathered outside the Supreme Court. Aid Access, a group that ships abortion pills across the country, had robots outside the court dispensing pills while one activist held up a sign saying, “I’m (a) trans man, and I need abortion pills.”
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Here at the Supreme Court, where Aid Access is distributing abortion pills with robots. Dystopian, much? <a href="https://twitter.com/DallasExpress?ref_src=twsrc%5Etfw">@DallasExpress</a> <a href="https://t.co/JZMMTtdouz">pic.twitter.com/JZMMTtdouz</a>
&mdash; Patrick Hauf (@PatrickHauf) <a href="https://twitter.com/PatrickHauf/status/1772598892971835861?ref_src=twsrc%5Etfw">March 26, 2024</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
Pro-life groups have urged the Supreme Court to rule against the FDA, saying that the agency irresponsibly rolled back restrictions. 
“The FDA’s decision to weaken commonsense safeguards, removing doctors from the process, shows they prioritize ending unborn life over the health and safety of women,” said Dr. Ingrid Skop of the Charlotte Lozier Institute. “Their stories must be heard, but abortion advocates, working with corporate media, have gaslighted them into silence. I hope the Supreme Court holds the FDA accountable for their reckless actions.”
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Several scientific studies on the potential harm of abortion pills <a href="https://www.dailywire.com/news/completely-unjustified-medical-journal-retracts-major-studies-critical-of-abortion-pill-ahead-of-supreme-court-clash" target="_blank" rel="noopener">were retracted</a> in February, years after they were first published, when the publisher conducted a review due to a single reader complaint. The authors of the studies say the retractions are a politically motivated effort to discredit research that was cited in a federal judge’s order that sided with doctors looking to reinstate restrictions on mifepristone. They believe that the research was targeted to discredit findings on the potential dangers of mifepristone ahead of the Supreme Court&#8217;s consideration of the issue.

Women’s March Mobilizes Hundreds For “Bans Off Our Mifepristone” Action Outside Supreme Court

Supreme Court Hears Arguments On Allowing Mail-Order Abortion Pills

Courts

Pro-Life Movement

The U.S. Food and Drug Administration on Friday approved the first treatment in the United States to utilize the novel gene-editing technology Crispr.
Casgevy, a treatment developed using Crispr, is a treatment for sickle cell disease, a blood disorder that results from a genetic mutation that affects the protein in red blood cells responsible for delivering oxygen throughout the body. The mutation causes red blood cells to take on a “sickle” shape that can cause blood clots, low oxygen, and other side effects.
“Sickle cell disease is a rare, debilitating and life-threatening blood disorder with significant unmet need, and we are excited to advance the field especially for individuals whose lives have been severely disrupted by the disease by approving two cell-based gene therapies today,” Nicole Verdun, director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research, said in a <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease">statement</a>.
“Gene therapy holds the promise of delivering more targeted and effective treatments, especially for individuals with rare diseases where the current treatment options are limited,” she said.
Sickle cell disease most commonly affects black people, though Hispanic people also occasionally inherit it.
The disease affects the production of adult hemoglobin protein, which caused blood cells to take on the distinct shape. The human body has two genetic codes for the production of hemoglobin, a code for fetal hemoglobin and a code for adult hemoglobin. After birth, the production of fetal hemoglobin is turned off and adult hemoglobin production is started.
The treatment for sickle cell, Casgevy, uses CRISPR technology, first developed about a decade ago, to edit the genes responsible for the production of fetal hemoglobin to restart production.
“We’ve kind of been waiting for this ever since DNA was first discovered,” Lewis Hsu, chief medical officer for the Sickle Cell Disease Association of America, told <a href="https://www.cnn.com/2023/12/08/health/first-crispr-gene-editing-treatment-sickle-cell-disease-scn/index.html">CNN</a>. “It’s been a long, long time coming.”
During trials, the drug was about 90% effective at stopping severe pain and organ damage caused by sickle cell disease for at least a year
“A total of 44 patients were treated with Casgevy. Of the 31 patients with sufficient follow-up time to be evaluable, 29 (93.5%) achieved this outcome. All treated patients achieved successful engraftment with no patients experiencing graft failure or graft rejection,” the FDA said.
The treatment has yet to be priced, though early estimates suggest it could cost millions. The Institute for Clinical and Economic Review, which advises insurance companies and drug makers on the fair price of therapies, said that a fair price for Casgevy would be between $1.35 million to $2.05 million per patient, according to <a href="https://www.wsj.com/tech/biotech/fda-approves-worlds-first-crispr-gene-editing-drug-for-sickle-cell-disease-8c65fbb3?mod=e2tw">The Wall Street Journal</a>.
Also on Friday, the FDA approved another cell-based gene therapy for sickle cell, Lyfgenia. Lyfgenia modifies the patient’s cells to produce a substitute for the defective hemoglobin protein.

CRISPR/Cas9 process

FDA Approves First Treatment Using Novel Gene-Editing Tech

Medical

Therapy

Neuralink — Elon Musk’s neurotechnology startup company — announced on Tuesday that recruitment is open to implant a wireless brain-computer interface in its first in-human clinical trial.
Company officials describe the PRIME Study — short for Precise Robotically Implanted Brain-Computer Interface — as a groundbreaking investigational medical device trial designed to evaluate the safety and assess the functionality of an implant and surgical robot for people with severe degenerative diseases, such as amyotrophic lateral sclerosis (ALS), to control external devices with their thoughts.
“During the study, the R1 Robot will be used to surgically place the N1 Implant’s ultra-fine and flexible threads in a region of the brain that controls movement intention,” the company <a href="https://neuralink.com/blog/first-clinical-trial-open-for-recruitment/" target="_blank" rel="noopener">announced</a>. “Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention.”
“The initial goal of our [Brain-Computer Interface] is to grant people the ability to control a computer cursor or keyboard using their thoughts alone,” the company added.
Applicants with quadriplegia due to cervical spinal cord injury or ALS may qualify for the trial, officials said.
Musk has touted that over the years, the experimental brain-chip implant could treat neurological disorders such as paralysis and blindness by bridging signals between existing neurons and allowing humans to save and replay memories, <a href="https://www.dailywire.com/news/elon-musks-neuralink-startup-receives-fda-approval-for-first-in-human-brain-chip-implant-clinical-study" target="_blank" rel="noopener">saying</a> that “the future is going to be weird.”
Musk <a href="https://www.cnbc.com/2023/05/25/elon-musks-neuralink-gets-fda-approval-for-in-human-study.html" target="_blank" rel="noopener">reportedly</a> said at a “show and tell” recruitment event late last year that he would likely implant himself with the neurotechnology.
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“You could have a Neuralink device implanted right now, and you wouldn’t even know,” Musk said at the time. “In fact, in one of these demos, I will.”
The company received approval from the U.S. Food and Drug Administration (FDA) in May to launch its first-in-human clinical study.
Neuralink received FDA breakthrough designation for its technology three years ago, and Musk repeatedly claimed that human trials would begin immediately. However, the company had its application rejected in early 2022 by the FDA over safety concerns.
Seven current and former FDA employees <a href="https://www.reuters.com/investigates/special-report/neuralink-musk-fda/" target="_blank" rel="noopener">told</a> Reuters earlier this year that the agency’s major safety concerns involved “the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue.”
“We want to be extremely careful and certain that it will work well before putting a device into a human,” Musk said, according to Reuters. “The progress at first, particularly as it applies to humans, will seem perhaps agonizingly slow, but we are doing all of the things to bring it to scale in parallel. So, in theory, progress should be exponential.”
The approval comes as U.S. lawmakers requested that regulators <a href="https://www.reuters.com/world/us/us-lawmakers-seek-probe-how-elon-musks-brain-chip-venture-oversees-animal-2023-05-12/" target="_blank" rel="noopener">investigate</a> how the company has conducted animal testing and if those trials were rushed or resulted in failed experiments.
Neuralink has also faced other federal investigations, including from the USDA’s Inspector General over concerns of violating the Animal Welfare Act and the U.S. Department of Transportation over accusations over the movement of hazardous pathogens.

Neuralink Illustrations

Musk’s Neuralink Opens Recruitment For First In-Human Brain Chip Clinical Trial

Musk's Neuralink Opens Recruitment For First In-Human Brain Chip Clinical Trial

Artificial Intelligence

Brain

Elon Musk

Technology

When the government suddenly announces a recall, or even talks about pulling a product from the shelves, it&#8217;s normal to assume that some unexpected defect has recently been discovered. Maybe the feds have noticed that a car&#8217;s airbags don&#8217;t deploy during a crash, or that a certain brand of fish tank is prone to spontaneous implosion. Whatever the case, you&#8217;re inclined to think that some new information has come to light that necessitates the recall. And in most circumstances that&#8217;s true.
But there is one industry —Big Pharma — that has consistently been the exception to this rule. This is an industry that happens to enjoy a lot of special treatment from the federal government, including immunity from lawsuits. In the pharmaceutical industry, a recall doesn&#8217;t necessarily mean that some catastrophic defect has just been identified. Instead, it often means that there&#8217;s been a known problem for a very long time — one that&#8217;s been deliberately hidden from the public, until finally it&#8217;s impossible to deny any longer. After COVID, most of the country realizes that this kind of thing can happen. What they might not realize, because there&#8217;s a mountain of propaganda designed to hide this fact, is how common this is.
Here&#8217;s the latest example. Right now the pharmaceutical industry is debating whether to issue one of the biggest recalls in modern history. The recall would affect a wide array of over-the-counter cold medicines, including some products bearing the brand names Mucinex, Tylenol, Sudafed, NyQuil, and Benadryl. The reason? According to the government, these products <a href="https://www.nytimes.com/2023/09/12/health/cold-medicine-decongestant-fda.html#:~:text=996-,A%20Decongestant%20in%20Cold%20Medicines%20Doesn%27t%20Work%20at%20All,time%20to%20substitute%20other%20ingredients." target="_blank" rel="noopener">don&#8217;t work</a>. At all. 
To be clear, as we&#8217;ll explain in a second, some Benadryl and Sudafed products still work, according to the government. We&#8217;re talking about a certain but very popular subset of these over-the-counter products that use a specific ingredient. At the same time, if you&#8217;re one of the hundreds of millions of people who have consumed these products over the past decade, this is a big headline. You paid money for a product that you thought worked, on assurances from the government and Big Pharma. You then ingested this product, based on those assurances. And now you&#8217;re being told that these pills had all the effectiveness of eating a cookie and drinking some warm milk.
One of the first questions you&#8217;d think to ask, under these circumstances, is when exactly the regulators and the pharmaceutical companies figured out that these products are completely ineffective. If you listen to most news reports on this subject, you&#8217;ll be left with the impression that some new information came out. That impression would be completely wrong, but it&#8217;s what they&#8217;re presenting. Here, for example, is CBS News:
<iframe loading="lazy" title="FDA committee says nasal decongestants don&#039;t work" width="500" height="281" src="https://www.youtube.com/embed/57RtIN3CLqw?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe>
What&#8217;s left unmentioned in that report is that this significant alleged defect in these drugs — the fact that they don&#8217;t do anything — has been widely known for years. It&#8217;s not new information. Nearly a decade ago, in 2015, researchers at the University of Florida said they <a href="https://pharmacy.ufl.edu/2015/10/14/uf-researchers-ask-fda-to-remove-non-prescription-decongestant-from-the-market/" target="_blank" rel="noopener">found</a> conclusive evidence that many non-prescription decongestants didn&#8217;t work. “Scientific evidence continues to show that the most popular products on the market containing phenylephrine are ineffective.&#8221; (Phenylephrine, to be clear, is used in certain drugs like over-the-counter Sudafed. It&#8217;s not used in the brand of Sudafed you have to get from the pharmacist.)
The researchers continued: &#8220;We think the evidence supports that phenylephrine’s status as a safe and effective over-the-counter product should be changed. We are looking out for the consumer, and he or she needs to know that science says that oral phenylephrine does not work for the majority of people.”
<h4><a href="https://www.dailywire.com/episode/ep-1222-the-matt-walsh-show" target="_blank" rel="noopener">WATCH: The Matt Walsh Show</a></h4>
This was back during the Obama administration. The findings raised a lot of uncomfortable questions, such as: Why would the FDA approve a drug that&#8217;s effectively a placebo? Why were regulators still allowing Big Pharma to sell it? Why were people continuing to buy drugs that didn&#8217;t do anything? And where are the prosecutors? Isn&#8217;t it fraud to advertise products that don&#8217;t work? Shouldn’t there be penalties for making billions of dollars off of something that doesn’t do what it’s supposed to do?
By refusing to do anything about phenylephrine, the federal government dodged all of these questions. They also helped cover up their role in causing the problem in the first place. You rarely hear this discussed, but the supposedly useless ingredient in question, phenylephrine, wasn&#8217;t always used in medications like Sudafed. Twenty years ago, the key ingredient in the most popular form of Sudafed was a very different decongestant called pseudoephedrine. This ingredient, we can be reasonably confident, actually works.
But in 2006, the federal government made it a lot harder to get &#8220;real Sudafed&#8221; with this ingredient. Congress passed a law effectively requiring people to undergo background checks before they could walk out of the store with it. &#8220;Real Sudafed&#8221; was no longer an over-the-counter medication. The justification for this restriction, ostensibly, was stopping people from using the ingredient to make meth. We&#8217;ll be taking a lot of dangerous drug kingpins off the streets, they told us.
Once Congress passed that law, Big Pharma needed an alternative. Most customers don&#8217;t want to wait in line for a pharmacist every time they need a decongestant. So they&#8217;ll leave the CVS without making a purchase. So very quickly big pharma came out with a new form of Sudafed using a different ingredient, called phenylephrine. Big Pharma, and the federal government, told us it was the best of both worlds. This new form of Sudafed can&#8217;t be used to make meth. At the same time, we were assured, it&#8217;s just as effective as real Sudafed.
Shortly after that law was passed, there were reasons to doubt the narrative that the government was pushing. For one thing, because of all these changes, a lot of innocent people were <a href="https://reason.com/2006/12/24/man-arrested-for-allergies/" target="_blank" rel="noopener">arrested</a> for no reason. One of them was named Tim Naveau. He was charged with a federal crime for buying too much Claritin. He wanted to get some extra pills for his son, who was going away to camp. In response, local officials arrested the man. They didn&#8217;t care that he wasn&#8217;t making meth. They charged him anyway. They said he was collateral damage in the larger meth war, which this legislation would help the federal government win.
Nearly two decades later, we learn that nothing we were told turned out to be true. For one thing, meth has never been easier, or cheaper, to obtain in this country. It&#8217;s not coming from domestic meth labs, for the most part. Instead it&#8217;s coming from Mexico, across a border that the federal government has deliberately left open. And on top of that, according to the government, the substitute Sudafed and related drugs were not effective, as we were promised. It&#8217;s useless. The new narrative is that Big Pharma made billions of dollars every year selling products that did not work. They knew it. The federal government let them do it.
Why are they telling us now? Is anything they&#8217;re telling us true? That&#8217;s a question we can&#8217;t answer, because both Big Pharma and federal regulators have lied so routinely, so consistently, that there&#8217;s no reason to take anything they say at face value. If recent history is any indication, it&#8217;s probably not a good sign. Normally when the federal government says a drug doesn&#8217;t work, there&#8217;s two possibilities.
The first possibility is that they&#8217;re trying to drive up sales of some other drug. We saw that during COVID: &#8220;Don&#8217;t take that therapeutic; it&#8217;s horse tranquilizer. Take our shot instead.&#8221; In the case of these decongestants, there&#8217;s long been a push to require prescriptions. In various states, activists and politicians have said it&#8217;s not enough to hide these decongestants behind the counter, and to track their sale. They say it&#8217;s necessary to require people to get a prescription first. This has been going on for a while. Here&#8217;s one report in Indiana from a decade ago, for example:
<iframe loading="lazy" title="Should a prescription be required for purchasing pseudoephedrine?" width="500" height="281" src="https://www.youtube.com/embed/34TDQcVRqG4?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe>
So this is the first possibility for why they&#8217;re pulling these drugs. Maybe it&#8217;s part of a larger effort to shift these decongestants to a prescription model, so that more people are seeing doctors and pharmacists — and there’s more money being made by everyone involved.
That&#8217;s one theory. The other possibility is that the FDA&#8217;s fraud simply couldn&#8217;t go on any longer, because the evidence that they&#8217;re lying about these drugs&#8217; effectiveness was becoming too overwhelming. If that&#8217;s the case, it wouldn&#8217;t exactly be the first time something like that happened. It was just a couple years ago that the FDA unanimously <a href="https://www.npr.org/2021/06/11/1005567149/3-experts-have-resigned-from-an-fda-committee-over-alzheimers-drug-approval#:~:text=Three%20experts%20have%20now%20resigned,every%20member%20on%20the%20panel." target="_blank" rel="noopener">approved</a> an Alzheimer&#8217;s drug called Aduhelm that didn&#8217;t work. This is one of the most expensive drugs available on the market. It costs more than $50,000 per year, per customer.
But the approval process didn&#8217;t go as smoothly as the FDA and the drug maker, called BioGen, would have liked. Several of the FDA&#8217;s experts resigned in protest after the agency approved Aduhelm, even though there was no evidence it did anything to treat Alzheimer&#8217;s. Here&#8217;s one of the experts who quit:
<iframe loading="lazy" title="A new Alzheimer&#039;s drug brings hope, controversy" width="500" height="281" src="https://www.youtube.com/embed/VVM5a6D3l6U?start=297&#038;feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe>
As you just heard, the entire premise of the drug was that you can cure Alzheimer&#8217;s by removing so-called &#8220;sticky plaques&#8221; in the brain. But it later emerged the research supporting that theory, which appeared in Nature magazine, was <a href="https://www.nbcnews.com/science/science-news/alzheimers-theory-undermined-accusations-fabricated-research-rcna39843" target="_blank" rel="noopener">doctored</a>. On top of that, serious side effects of the drug emerged, including brain bleeding.
So why did the FDA approve the drug? It turns out the agency had a <a href="https://www.nbcnews.com/health/health-news/fda-broke-protocols-approving-biogen-alzheimers-drug-congressional-rep-rcna63662" target="_blank" rel="noopener">close relationship</a> with the drug company, BioGen, throughout the approval process. This relationship, Congress later determined, broke the FDA&#8217;s own rules. But it worked out for BioGen. 
We see this phenomenon again and again. The federal government tells us that a drug works, and that they know exactly how it works. By the time we find out they&#8217;re lying, the drug company has made a ton of money. We saw something similar happen with SSRIs. For decades, we were told that low serotonin levels were linked to depression. Therefore, SSRI&#8217;s would fix that problem by allowing more serotonin in the brain. Even as mass shootings and depression and suicide rates all went up, we were assured by Big Pharma and the media that SSRI&#8217;s were working. That was what the science said, and if you disputed it, you&#8217;re a troglodyte. It only emerged last year that, in fact, low serotonin isn&#8217;t <a href="https://www.tpr.org/bioscience-medicine/2022-12-28/research-concludes-low-serotonin-does-not-cause-depression-what-does-that-mean-for-ssris" target="_blank" rel="noopener">linked</a> to depression at all.
Somehow that wasn&#8217;t a major scandal. SSRIs — which stands for selective serotonin reuptake inhibitors — were never pulled from the shelves, even though the official position of the scientific community is that low serotonin doesn&#8217;t cause depression. There were no massive class-action lawsuits that bankrupted the companies that made billions of dollars from these SSRIs, just as BioGen hasn&#8217;t been held accountable for its worthless Alzehimer&#8217;s drug, and just as no one in the Sackler family went to prison for lying about the addictiveness of opioids.
For all those reasons, we can assume Big Pharma and the government will continue to lie to us. If they don&#8217;t face consequences, they have no reason to change what they&#8217;re doing. That&#8217;s why, at this moment, our political leaders are gearing up for a new round of COVID decrees. These decrees have already arrived in Canada, where public health officials are now calling for children as young as six-months-old to receive COVID shots.
There are no clinical trials or studies that demonstrate that it&#8217;s safe or necessary in any way to give COVID shots to six-month-old children. Not a single one. And, to be honest, even if they had conducted trials, there would be reason to doubt those, as well. We are now at the point where, whatever the class of drug we&#8217;re talking about — whether it&#8217;s Alzheimer&#8217;s treatments, COVID shots, SSRIs, even decongestants — you can assume you&#8217;re being lied to. If you consume drugs that Big Pharma and the federal government are pushing, you&#8217;re running the risk that ten or twenty years from now, you&#8217;ll learn what it&#8217;s actually doing, and what the actual side effects might be. Whatever you take, and whatever your kids take, you simply have to factor that doubt into the equation. You have to keep in mind that, if something bad happens down the line, you&#8217;ll be told it&#8217;s breaking news, and that no one could have seen it coming. Even though the people who made the drug, in fact, knew it was coming. 
Is this an ideal situation from a public health perspective? Of course not. But it&#8217;s the system we have. And if there&#8217;s any upside to the news this week, it&#8217;s that no one — not even people who are just shopping for a decongestant — can deny it anymore.
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