FDA Loses Its War on Ivermectin

Guest post from journalist Eric Starkman

I’ve published hundreds of posts since launching this blog, and the ones I’m most proud of focused on Dr. Mary Talley Bowden, the Houston ENT doc who ran afoul of the U.S. government, the medical establishment, and the Biden Administration’s corporate media sycophants at the height of the pandemic. I love a good David vs. Goliath story, and this being Women’s History Month, it’s delicious irony that our modern-day David is named Mary.

I first profiled Bowden in February 2022 after Houston Methodist, a powerful Texas hospital system and the first in the U.S. to mandate Covid vaccines for its employees, moved to suspend Bowden pending an investigation for allegedly “spreading dangerous misinformation which is not based in science.” Bowden’s sin: Prescribing a low-cost drug called ivermectin to treat Covid, which the FDA insisted was a veterinary drug that was an ineffective treatment for the pandemic virus.

Bowden maintained she had considerable success using ivermectin to treat her legions of Covid patients, an expertise she developed because of her willingness to treat pandemic patients that Houston-area physicians shunned. Other U.S. physicians claimed they also had success treating Covid patients with ivermectin, but only a few dared to admit it.  

Ivermectin is a drug first used to treat parasitic diseases and is included on WHO’s essential medicines list. The drug is credited with savings millions of lives, which is why the medicine’s developers in 2015 were awarded a Nobel Prize. Ivermectin was later found to be an effective treatment for animals and reformulated for veterinarian purposes.

Nevertheless, the FDA posted a message on Twitter and Facebook featuring a healthcare worker standing next to a horse with a caption, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The corporate media dutifully amplified the FDA’s message that ivermectin was a veterinary drug and widely republished the FDA’s tweet.

Also piling on was the American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists, which issued a joint statement strongly opposing “the ordering, prescribing, or dispensing of ivermectin to prevent or treat COVID-19 outside of a clinical trial.”

The corporate media coverage of Bowden was universally hostile, portraying her as a quack despite having trained at Stanford, ranked one of the top medical schools for ENT. A representative example was this NBC News story by Marlene Lenthang, which said Bowden was treating Covid patients with a drug “typically used to deworm animals.”

My second Bowden post was in June 2022 when I wrote about a lawsuit filed in the United States Southern District of Texas on behalf of Bowden and two other defiant but well credentialed physicians – Paul Marik and Robert Apter – who also maintained that ivermectin was an effective drug to treat Covid. Any hack lawyer can file a lawsuit, but I took note that Bowden’s was filed by Boyden Gray & Associates, whose eponymous founder’s name I instantly recognized. Boyden Gray, who died last May, opposed the administrative state and regulatory overreach, which made him unpopular among the Beltway crowd.

Boyden Gray’s long and distinguished career is outlined here and his myriad achievements include serving as counsel to the Vice President during the Reagan administration and then as White House Counsel to President George H.W. Bush, where he was responsible for judicial selection and played a significant role in the enactment of Clean Air Act Amendments of 1990, the Energy Policy Act of 1992, and cap-and-trade system for acid rain emissions. Under George W. Bush, Gray served as U.S. Ambassador to the European Union.

I published my third Bowden post in July 2022 after reading Bowden’s defamation lawsuit against Houston Methodist and its CEO Dr. Marc Bloom. I was particularly saddened by this paragraph, one that should be required reading for med school students to teach them about the repercussions of challenging the government and the medical establishment:

Methodist and Boom’s false and defamatory Statements injured Dr. Bowden.  She lost patients.  She lost business opportunities and substantial income.  Her reputation as a physician was severely compromised.  The Statements thrust Dr. Bowden into a public controversy and fundamentally changed her life.  She is self-conscious in places and at times she was not before.  She fears for her safety and the safety and welfare of her children.  She worries about schools, physicians and therapists treating her children differently because of the damage done to her reputation (for example, her son was not accepted to any of the four private schools he applied to for high school and Dr. Bowden was informed by a board member at one of them that it was because of the Statements published by Methodist).  Dr. Bowden was featured in the Houston Chronicle as one of the most controversial Houstonians of 2021.  Methodist and Boom’s egregious and unnecessary attacks insulted, humiliated, shamed and traumatized Dr. Bowden.

My instincts about Boyden Gray’s law firm proved correct. After initially having their case thrown out on the basis that the FDA enjoyed “sovereign immunity,” the U.S. Court of Appeals reversed the lower court’s decision, declaring “the FDA is not a physician” and that, “even tweet-sized doses of personalized medical advice are beyond the FDA’s statutory authority.”

Boyden Gray lawyers refiled the case, and it was determined that only Bowden had standing. The FDA opted to settle the case, and agreed to immediately remove a consumer update titled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and all other false references deriding ivermectin as a veterinary drug within three weeks.

The FDA wants the public to believe that it settled the case to avoid the time and cost of lengthy litigation.

“The agency has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old,” Newsweek quoted the agency as saying. The FDA also insisted it “has not admitted any violation of law or any wrongdoing, disagrees with the plaintiff’s allegation that the agency exceeded its authority in issuing the statements challenged in the lawsuit, and stands by its authority to communicate with the public regarding the products it regulates.”

It doesn’t speak well of the FDA’s character or resolve that it was willing to back off one of its most critical messages at the height of the pandemic to promote its narrative that vaccines were the only line of defense to survive Covid. Someone less charitable than me might speculate the FDA opted to settle to avoid being subjected to the discovery process and forced to produce documents that might reveal information it would prefer the public didn’t know.  

There are legions of FDA supporters who defend the agency’s dishonesty, arguing ivermectin is ineffective treating covid and producing studies purporting to back up their claims. The end justified the means is their implicit argument.

The problem with studies these days is that many, if not most, are funded by the government and Big Pharma, and some are structured to achieve desired results. As an example, Bowden showed me an ivermectin study years ago where the control group was comprised of people in the advanced stages of Covid. Physicians who championed ivermectin as a Covid treatment said it worked best in the early stages or as part of a cocktail.

For those who fashion themselves as experts understanding and interpreting medical studies, here’s a link to a website with more than 3,500 studies about the adverse effects of Covid vaccines.

Regardless of ivermectin’s merits, the goal of Bowden’s lawsuit was to prevent the FDA from telling her how to practice medicine. “Our goal was to limit FDA overreach into the doctor/patient relationship,” she said in a telephone interview.

The FDA once employed two of the most highly regarded vaccine experts in the world, Marion Gruber and Phil Krause, who I’ve previously written about. Gruber and Krause respectively worked at the FDA for 32 and 11 years. Yet at the height of the pandemic, both experts resigned their positions, reportedly because of undue political pressure from the Biden Administration and Dr. Fauci to approve Pfizer vaccine boosters for all Americans 16 and over.

On their way out the door, Gruber and Krause co-authored a paper with top WHO officials in the prestigious UK medical journal The Lancet arguing that booster shots weren’t yet needed for the general public and that available doses would best be used for individuals who were not yet vaccinated.

President Biden’s Covid czar was Jeffrey Zients, and its hardly reckless speculation that he likely played a role in the resignations of Gruber and Krause. Rest assured, if Gruber and Krause had resigned under pressure from the Trump administration, the corporate media would have howled. Zients, who I’ve previously written about, is now Biden’s chief of staff.

The FDA has long faced accusations of being unduly controlled and influenced by Big Pharma, but it’s influence with regards to Covid treatments appears to be waning.

The FDA gave emergency use approval for the drug Paxlovid to treat Covid and ultimately full approval, but physicians have become increasingly concerned about the product because it can trigger adverse reactions in combination with a myriad of other drugs. Notably, Bowden was a critic of Paxlovid from the get-go; when I asked her about the drug, she immediately rattled off a dozen potential adverse reactions that made clear she was an avid reader of medical journals and literature.

Pfizer had huge expectations for Paxlovid, but it was forced to resort to hiring two PR firms to peddle the product. This Substack article by investigative journalist Linda Bonvie captures how easy it was for Pfizer to dupe the Los Angeles Times and to a lesser extent the New York Times about Paxlovid’s supposed merits.

As for Bowden, she remains as modest and unassuming as ever. Bowden is another validation of the Starkman Approved Theory, which holds there is an inverse relationship between those who profess to adhere to the highest standards and values, and how they actually govern their lives and businesses.

In yet another validation, Houston Methodist, which publicly ridiculed Bowden for “spreading dangerous misinformation which is not based in science,” was cited by a respected watchdog group for performing needless stent surgeries during the pandemic. The science is overwhelmingly conclusive that most stent surgeries are unnecessary.

Despite having forced the FDA and the Biden Administration to eat crow, Bowden is remarkably restrained given all that she’s accomplished.

Asked to reflect on the ordeal she’s undergone these past few years, Bowden replied: “I never thought I’d be in the crosshairs of the FDA. I’m just a solo physician in the suburbs of Houston.”

Eric Starkman is a journalist and blogger who regularly posts on LinkedIn. To read more about him and subscribe to his blog, please go to his website, Starkman Approved.