About a year ago, I started to notice Dr. Tess Lawrie was promoting ivermectin as a miracle cure for cancer. Dr. Lawrie, as you might remember, is a British physician who first made a name for herself in the COVID-19 contrarian and antivax movement as one of the founders of the Bird Group in the UK, a group that was (and still is) dedicated to the “approval” by regulators of ivermectin as a treatment for COVID-19. Basically, my take at the time was that the Bird Group is basically the UK version of the Frontline COVID-19 Critical Care Alliance (FLCCC), an American antivax group born during the pandemic that promotes all manner of COVID-19 minimization, antivaccine views, and, of course, “cures” for COVID-19, in particular ivermectin, which they have claimed to be “repurposing” to be a prominent part of its “protocols” to treat the disease. Unsurprisingly, Dr. Lawrie has been closely aligned with American COVID-19 quacks like Dr. Pierre Kory at least since 2021, and even less surprisingly the “indications” for ivermectin started expanding beyond COVID-19 and cancer, leading me to quip last March that ivermectin now reminds me of Miracle Mineral Solution/Supplement (MMS), a.k.a. a form of bleach. It was then brought to my attention last week that the FLCCC is apparently all-in now when it comes to “repurposing” ivermectin to treat not just COVID-19, but cancer:

Ivermectin. They’re mainly talking about ivermectin.

I had never heard of Dr. Kathleen Ruddy before, but apparently she is a breast cancer surgeon in New Jersey, which embarrasses the hell out of me as a breast surgeon devoted to science who once practiced and did research in New Jersey for over eight years. All I have to do is to link to her blog to show why, given how the blog provides ample evidence that she is at least hardcore COVID-19 antivax. In addition, her X/Twitter profile looks like this:

Kathleen Ruddy repurposing
She’s going to run a study on repurposing drugs to treat cancer?

I note that Radius Health Exchange is a standard “health freedom” doctors’ website, basically a directory for COVID-19 quacks but also maintains an “unvaccinated blood” registry for those antivaxxers who need a transfusion and think that blood products from people who have received COVID-19 vaccines are hopelessly “contaminated.” I was half-tempted to create an account, you know, for yucks and to see what sorts of emails I would get, but ultimately thought better of it.

Moving on (and more relevant to her medical beliefs), I note that Dr. Ruddy is also the founder of the Breast Health & Healing Foundation, the goal of which is to “answer the question, Does a virus cause breast cancer in women? within five years” and has published a book entitled The End of Breast Cancer: A Virus and the Hope for a Vaccine, whose primary thesis is that a virus “plays a significant role in 40-94% of human breast cancer.” (So apparently she’s not antivaccine when it comes to cancer vaccines. Interesting.) In brief, she believes that a mouse virus known to cause mammary tumors in mice called, appropriately enough, mouse mammary tumor virus (MMTV), causes 75% of human breast cancers., which she has also called the “pink virus.”

Kathleen Ruddy
I also note that Dr. Ruddy states that she has a continuous desire to find a “pure cure” for cancer. That’s a red flag. So is the claim that there is one primary cause of any cancer.

I was puzzled by this whole hypothesis, not so much because I don’t believe that viruses can’t cause breast cancer, but rather because Dr. Ruddy had chosen a mouse virus as The One True Cause of (most) breast cancer. Moreover, it is true that regulatory elements from the virus have been studied in human breast cancers and that the virus produces a mouse model that resembles human breast cancer more than most mouse models. However, MMTV is a mouse retrovirus. It is true that there is evidence of a virus similar to MMTV in some human breast cancers (BC), but, as a recent review characterized the question, “controversy about whether this virus was linked to BC has raged for over 40 years in the literature,” and the review actually lays out that controversy quite well, stating that there is “compelling evidence that HMTV may be involved in its tumorigenesis,” that therefore the “effort to investigate HMTV-positive neoplasms and the virally related immunological alterations in further depth should go forward in order to develop more effective prevention, control, and therapeutic strategies,” concluding that further “investigations are needed to solidify these observations.” (HMTV=human mammary tumor virus.)

Also from the review:

In 2005, Indik et al. showed, first, that MMTV could infect human cells [24], and then that human cells could support replication of MMTV [106], thus suggesting that human cells are permissive for MMTV. These were two essential prerequisites to hypothesize that an infectious agent similar to MMTV might play some role in human BC. A study in 2010 reported that, in humans, MMTV-like virus could be detected in between 14% and 74% of breast cancers [107]. However, over time, the results of these studies were questioned. Indeed, other groups worldwide could find no evidence of this virus in BC tissue nor any association between HMTV and human BC. Others regarded positive detection of HMTV in samples as environmental contamination, or as non-specific [6,10]. As a matter of fact, the search for an MMTV-like virus has been complicated by the potential presence of HERVs integrated in the human genome, as well as Mtv in the murine one, that required differentiating from possible MMTVels.

In other words, let’s just say that Dr. Ruddy is presenting a scientific controversy about the role of an MMTV-like virus in breast cancer as though it were settled science being “suppressed” by The Man, another red flag for a crank. That, and her willingness to collaborate with the quacks at FLCCC do not reflect well on how science-based a physician and surgeon Dr. Ruddy likely is, given what a grifting quack Dr. Marik has consistently demonstrated himself to be.

On to the FLCCC conference, at least what I can find out about it.

The FLCCC is “repurposing” drugs for cancer by teaming with quack clinics

The FLCCC hasn’t released video of its conference, at least not as of my writing this yesterday, but they have issued a press release, FLCCC Alliance Announces Its First Groundbreaking Study to Determine Efficacy of Repurposed Drugs in Treating Cancer. The first red flag that strongly suggests that this “study” won’t be science-based is in the first sentence:

A team of U.S. clinicians will participate in an observational study to determine improvements in the five-year survival rate for several types of cancer.

That’s right. The FLCCC is touting an observational study that will look at the five year survival rates for various types of cancer. I couldn’t help but get a bit sarcastic on X, the platform formerly known as Twitter, when I saw the FLCCC post:

Oops. I meant an FDA-approved drug for amyotrophic lateral sclerosis (ALS), NOT Alzheimer’s disease (although riluzole is under study for Alzheimer’s). Brain fart. Oh, well.
Was I too harsh?

That’s right. I’ve been studying the repurposing of a legitimate FDA-approved drug for amyotrophic lateral sclerosis (ALS), riluzole, to treat triple-negative breast cancer for a number of years. Ironically, problems that I’ve encountered, such as difficulty achieving in vivo the blood levels required to kill cancer cells previously measured in vitro, are very similar to the problems with ivermectin and COVID-19, although not nearly as marked. As I’ve discussed, the concentration in vitro required to inhibit the replication of SARS-CoV-2, the virus that causes COVID-19 is 50- to 100-fold higher than what can be safely achieved in the human bloodstream. At least for riluzole (in mice at least) the difference is nowhere near that dramatic, but it’s still a challenge for repurposing the drug.

So let’s look at what the FLCCC actually plans to do:

Today, at their sold-out education conference, the FLCCC Alliance announced that it has partnered with renowned breast cancer physician and researcher Kathleen Ruddy, MD, to conduct an observational study in five U.S. clinics to track patient responses to various adjunct cancer therapies using repurposed drugs and determine improvements in the five-year survival rate to several types of cancer including breast, prostate, lung, and colorectal.

Notice how the FLCCC assumes that there will be improvements in five-year survival rates in these cancers due to their repurposing drugs to treat them. A more objective way to have phrased this would have been “determine changes,” not “determine improvements,” but the FLCCC already believes that their repurposed drugs will treat cancers:

“We hope that our research will bring attention to often overlooked methods for treating cancer as well as managing the symptoms from conventional treatment,” said Paul E. Marik, M.D., FCCM, FCCP, lead author of the study, chief scientific officer of the FLCCC and former Chief, Pulmonary and Critical Care Medicine at Eastern Virginia Medical School. “Our research is intended to advance a better understanding of how cancer can be treated more efficiently, with fewer side effects, through using well-studied approaches that include readily available medications that are well-studied and known to have minimal side effects.”

The final study results will focus on improvements in the five-year survival rate of certain cancers and include patients from five clinics nationwide that will collaborate and share anonymous patient information in a centralized collection tool where the data will be tracked and analyzed.

“Cancer continues to increase at an alarming rate, especially among younger populations, creating an imminent public health crisis,” said Kathleen Ruddy, MD, founder of the New Jersey-based practice Breast Health and Healing. “For over a year, I have been observing and advising 50 patients using a variety of repurposed treatments in the regimen, with some having remarkable results. More is to be learned, so I am excited to partner with the FLCCC on this new research.”

This statement suggests that Dr. Ruddy has already been treating patients with “repurposing” of various drugs. She even claims that she’s had “remarkable” results, but what does that even mean? I also have to wonder: Where is the ethical approval for this study? Where is the institutional review board (IRB) approval? Sadly, quacks have long done “studies” like this without IRB approval because there’s really no way to enforce IRB approval outside of the need for FDA approval for a drug or device, or the investigator having obtained government funding through the NIH, NSF, or other agency to support the study and/or working for an academic or research institution that accepts federal funds. Long is the sordid history of quacks doing “studies” without IRB approval (or, as in the case of Mark and David Geier, for instance, creating their own dubious IRB to approve their studies, as did cancer quack Stanislaw Burzynski). And, no, “anonymous sharing” doesn’t relieve that burden. These “institutions” are purporting to do human subject research, and, while the data might be anonymized, there must still be a database that links the clinical data to protected health information (PHI) of the subjects.

Now let’s look at the sites where this “study” is being carried out:

The five clinics participating in the study are:
  • Breast Health and Healing, led by Kathleen Ruddy, MD.
  • Leading Edge Clinic, led by Pierre Kory, MD, MPA and Scott Marsland, FNP-C
  • Brio Medical, a holistic, integrative cancer healing center, led by Nathan Goodyear, MD
  • Meakin Metabolic Care, led by Charles Meakin, MD
  • James Clinic, led by Mollie James, MD

It’s interesting to me that Dr. Ruddy’s Breast Health and Healing clinic seems to have a very low Google profile. I couldn’t find an actual practice website, only a website for Dr. Ruddy that declares her to be a “surgeon, author, inventor, healthcare leader.” Sadly, as has been the case with many doctors who’ve “gone rogue,” Dr. Ruddy appears to have wasted excellent credentials, having done a breast surgery fellowship at Memorial Sloan-Kettering Cancer Center in the 1990s. She also has some not-so-great credentials that are big red flags to me, such as touting here appearances at COVID Madness events, where she appeared with antivax cranks and quacks like Stephanie Seneff, Peter McCullough, Christiane Northrup, Geert Vanden Bossche, Lee Merritt, David Martin, Aseem Malhotra, Sherri Tenpenny, Pierre Kory, Bret Weinstein, Mark Skidmore, and others, a veritable who’s who of the COVID-19 era antivax movement.

As for the Leading Edge Clinic, run by Pierre Kory, there’s not much to say other than to refer you to all the times we at SBM have written about this COVID-19 quack who’s been branching out into more general quackery. If you want to know just how quacky Dr. Kory has become, let’s just say that he has been promoting stories of COVID-19 vaccine “shedding” in which men would pick up the “shedding” from contact with the general public in their everyday life, bring it home, and then transmit it to their wives through oral sex. (Seriously, I kid you not.) Before I discuss the actual “study” proposed by FLCCC, let’s take a look at the rest of the “experts” who will supposedly be carrying it out.

What about the other doctors “repurposing” COVID-19 quackery to cancer?

I had never heard of most of these doctors; so let’s dig in and see what sort of quacks we’re dealing with, and, make no mistake, they are very quacky quacks:

Nathan Goodyear and Brio-Medical. Unlike the case for Breast Health & Healing, it didn’t take me long to find the Brio-Medical website and learn that it’s an alternative cancer clinic in Scottsdale, Arizona, run by “integrative cancer expert Dr. Nathan Goodyear, a renowned authority in integrative medicine.” (Hint: There are so many red flags in just that brief phrase.) Brio-Medical offers a veritable cornucopia of cancer quackery, such as insulin potentiation therapy (IPT), a dangerous and ineffective therapy based on the idea that sugar feeds cancer cells and that one should lower a patient’s glucose as much as feasible with insulin to “potentiate” the activity of “low dose chemotherapy.” Basically, any clinic offering IPT is a quack clinic, but there are so many more quack cancer treatments listed on the Brio-Medical website, including hyperbaric oxygen, vibrational therapy, EBOO ozone therapy, high dose intravenous vitamin C, and many, many more quack treatments. I could go on, but regular readers who peruse the website of Brio-Medical will immediately recognize the quackery. If that’s still not enough, though, just note that Dr. Nathan Goodyear is not just an OB/GYN, but an MDH (homeopath) as well. Yes, one of the investigators of this “study” is a practitioner of what I like to call The One Quackery To Rule Them All. How much confidence does that give me in his ability to carry out his part of a study like this? Let’s just say a homeopathically diluted amount, except that in this case more dilution doesn’t make my confidence stronger.

Meakin Metabolic Care. Dr. Charles Meakin is no better. The name of his clinic, Meakin Metabolic Care, should tell you all you need to know about him, but also know that he’s an oncologist who claims that all cancer is in fact a metabolic disease. (I could go on and on about the controversy over how much cancer is in fact a metabolic disease compared to the contribution of gene mutations, as it’s a controversy that flares up at the scientific meetings from time to time, but whenever someone says that cancer is all metabolic (often invoking the Warburg effect), it’s usually a pretty good indication of quackery, especially when it comes from a doctor who offers a panel that he calls his Metabolic Optimization Protocol, which is described thusly:

Our current healthcare system does an abysmal job at preventive medicine. The annual blood work prescribed in a traditional primary care setting aims to detect disease after it occurs, not prevent it from occurring in the first place. Traditional laboratory values were developed to detect a disease state when values exceed a predetermined range yet fail to ask the critical questions that drive to the heart of preventive care: What are the value ranges for optimal health? What laboratory values signal the ideal cellular and organ function that elevates our health and prevents the chronic disease so common in old age? The cornerstone of the MOP program is more frequent and relevant bloodwork that provides deep insights into cellular and organ function. Our quarterly bloodwork panel looks at the laboratory markers most pertinent to health optimization and has actionable interventions that can bring them into the optimal range.

This sounds a lot like the quackery that is functional medicine, or, as I like to call it, reams of useless tests in one hand, a huge invoice in the other. (No, seriously, the fee for this program is $850 per quarter, or $3,400 per year.) He also sells modified citrus pectin supplements for cancer, but my favorite bit of quackery has to be Dr. Meakin’s Cancer Metabolic Optimization Protocol, which very much resembles the Metabolic Optimization Protocol, just for cancer, and costs $950 a quarter, or $3,800 a year. Tellingly, neither “optimization program” includes the cost of all the supplements and “repurposed medications” recommended, which range from $50-$150 per month); so the overall expense will be considerably more. (No wonder Dr. Meakin is so hot to repurpose ivermectin and other COVID-19 quackery for cancer!) As for the actual labs:

The full list of labs included in the C-MOP Program includes: Complete Blood Count, Complete Metabolic Panel, Lipid Panel, Hemoglobin A1C, C-Reactive Protein, Thyroid Stimulating Hormone, Magnesium Level, Lactate Dehydrogenase, Homocysteine Level, Vit D3 level, Uric Acid, Ferritin Level, Fasting AM Total Cortisol, and Fasting Insulin Level.

These are some pretty basic labs that any primary care doctor could order, most of which are fairly routine and easy to justify ordering and having them paid by insurance. To all this, Dr. Meakin adds Scan Shield, a bunch of antioxidant supplements that, he claims, will protect you from the effects of ionizing radiation that you might receive as a cancer patient undergoing scans. Through it all, Dr. Meakin requires patients to pay to get supplements and repurposed drugs from his partner’s compounding pharmacy rather than obtaining the repurposed drugs from a real pharmacy using their own health insurance, justifying it by saying that repurposed mebendazole is too expensive and:

They incorporate the traditional repurposed drugs in the same mailing package for convenience and organization for the patient to determine the proper way to take the medications. Using individual insurance plans and pharmacies directed by health insurance frequently leads to a detailed pre-approval analysis of repurposed drugs and off-label use. MMC strives to provide the lowest cost service, and we do not have staff to attempt to process through standard pharmacies and insurance plans, which are highly time-consuming.

Sure you do, Dr. Meakin. Sure you do. Functional medicine just loves “repurposing” drugs and supplements to treat whatever fantastical diagnoses it can come up with, based on ordering a crapton of unnecessary labs. There’s a reason why I refer to functional medicine as the “worst of both worlds,” combining the excessive ordering of tests that conventional medicine sometimes indulges in with a belief in pure woo.

James Clinic. Finally, there’s the James Clinic, founded by Dr. Mollie James. Unsurprisingly, she, too, is a functional medicine quack:

Dr James is board certified in general surgery and critical care medicine. She trained at Mercy Medical Center-Des Moines and the University of Minnesota. After practicing for five years, she realized she needed additional tools to help her patients. Functional medicine was the answer. She combined functional medicine into her surgery practice for patients with GI issues presenting for endoscopy and it had immediate benefit to patients. By using interventions such as elimination diets and gut-healing protocols, patients would often say they felt the best they ever had.

Not to mention:

Dr. James has now become an activist for medical freedom, patients right to choose, and physicians right to practice medicine unencumbered.

Because of course she has.

The James Clinic offers the usual assortment of quackery, including ozone therapy in the form of EBOO (extracorporeal blood oxygenation and ozonation), which “involves placing an IV in each arm and running blood out from one IV, through a dialysis filter, and exposing it to oxygen and ozone gas.” Then, of course, there are the usual IV vitamin infusions, unnecessary “bioidentical hormones,” and bogus treatments for “vaccine injuries,” among others. The clinic also features an online supplement store, because of course it does. (And, wow, are those supplements pricy!)

These are the doctors and clinics running this observational study. Even if the protocol were reasonably defensible from a scientific standpoint, I’d have serious doubts about the ability of these doctors to rigorously and, most importantly, ethically carry out even an observational study.

But what about the evidence and study?

I realize that I’ve spent a long time discussing the “who’s” of this study, but what about the study itself? I can just see antivax-sympathetic readers who happen to come across this post accusing me of ad hominem; i.e., attacking the idea of repurposing drugs for cancer and rejecting the study based on who is doing it rather than the study itself. Here’s the thing. In the absence of an actual protocol to study, all that’s left is the who, as in who’s doing the study, and the track record of these people. Moreover, far be it from me to be opposed to repurposing drugs for cancer, having spent the last decade-plus studying whether repurposing an ALS drug to treat breast cancer is feasible. (Just search PubMed for my name plus “riluzole.”) I wouldn’t have spent all that time and effort and applied to so many funding entities if I didn’t believe that repurposing certain drugs to treat cancer could work.

In fact, my background is a huge reason why this study sent up big red flags. Again, it’s strictly observational, and, given the nature of alternative medicine clinics for cancer, subject to extreme selection bias in that the patients are self-selected and very likely to be able to afford the high expense of such clinics and to have disease that is less severe. Indeed, the only clinical evidence that I could find reminded me very much of the cancer cure testimonials that I’ve been deconstructing since 2005, for example the case of John Ross, whose treatment for colon cancer at the James clinic was recounted in a Substack post Ivermectin Squares Off in a New War on Cancer:

John Ross was fifty-one years old when he was diagnosed, after more than a year of discomfort and growing unwellness, with Stage 3B colon cancer. A three- to four-inch tumor had almost completely blocked and broken through the organ wall; his surrounding lymph nodes were enlarged and presumed cancerous.

In May 2023, Ross started the traditional treatments offered by mainstream medicine—simultaneous radiation and an oral chemotherapy. He did not tell his mainstream cancer doctors that he was also taking, among other things, the repurposed generic drug ivermectin. The drug was famously—and wrongly—vilified as a horse medication during Covid, though it was in reality a Nobel Prize-winning “wonder drug” with huge untapped potential.

Ross and Dr. Mollie James, a functional-medicine physician who oversaw his nontraditional treatment, are modern-day medical trailblazers who might change the way cancer is treated. If they and others in a growing effort are successful, cancer care will be less painful, more affordable, and—the greatest hope—more effective. Practicing in a suburb of St. Louis, Dr. James had used ivermectin and other therapies to successfully fight Covid-19. (I wrote about her treatment of her brother in January of 2022.) She is now taking what she learned in the pandemic and turning it to cancer.

I suspect that you know what the problem with this cancer cure anecdote will be. If you don’t yet, let’s make it clear:

“I don’t know how you are standing here today—I’ve never seen blood this bad,” Dr. James told Ross after his thyroid result came in. First, she said, “I want to get you as healthy as possible before treatment.” Starting three weeks before radiation and chemotherapy, Ross began, along with ivermectin, infusions of high-dose Vitamin C and glutathione; major auto-hemotherapy, also called ozone therapy; and hyperbaric oxygen therapy, along with supplements like high-dose melatonin.

In the ensuing nearly six weeks of radiation and chemotherapy, oncologists, and others caring for Ross remarked repeatedly on how well he was doing. “Even the (radiation) technician, at the last week of treatment, made comments how this is so abnormal to have somebody that wasn’t dealing with any of the burns or anything like that,” including hair loss, Ross recalled.

The clincher, however, came in Ross’s MRI and CT scans in July of 2023. After twenty-eight radiation and chemotherapy treatments and nearly three months of the ivermectin protocol, “Ninety percent of his tumor had turned fibrous, meaning into scar tissue,” Ross’s wife, Roxanne, told me. “And the lymph nodes were half the size,” John added. An oncologist’s report called that an “excellent response.”

Now do you see it? As is so often the case with alternative medicine cancer cure “testimonials,” Mr. Ross underwent standard-of-care chemotherapy and radiation plus all the quackery. Basically, for stage 3B colon cancer that cannot first be removed surgically, the treatment is neoadjuvant chemotherapy and radiation before surgery to shrink the tumor and make it operable. (Neoadjuvant therapy is given before surgery.) There is therefore no way of telling from this anecdote whether the quackery added anything to the treatment response. The most parsimonious explanation, of course, is that the chemotherapy and radiation produced such a dramatic response in Mr. Ross’ colon cancer, given that neoadjuvant chemoradiation produces a significant response in the majority of patients, with a median reduction in size of nearly 70%. Contrary to the implication in the anecdote, the treatment response observed in Mr. Ross’ tumor was nothing out of the ordinary. It was completely within the range of what an oncologist would likely expect just from conventional therapy, given that such therapy can produce a complete pathologic response (no viable tumor cells detectable in the surgically resected specimen) in 5-10% of patients. I also couldn’t help but note with alarm that Mr. Ross appears never to have told his oncologists that he was taking other drugs. If there had been an interaction between the repurposed drugs and the chemotherapy, he could have suffered severe adverse reactions. Basically, Dr. James, by not insisting on letting Mr. Ross’ physicians know about the other drugs she was repurposing and administering to him while he was also undergoing chemotherapy and radiation, practiced highly unethical medicine, in my not-so-humble opinion. Moreover, Dr. James called this a “complete clinical response without surgery.” It’s not, and, even if it was, you can’t say that it was without surgically resecting the affected area of the colon and proving that there are no viable tumor cells left.

Let me show you what I mean:

Told that 10 percent of his tumor remained viable, John Ross started a second round of chemotherapy in late August of 2023, receiving one infusion followed by two weeks of oral drugs—in six two-week cycles with a recovery week between. Within twenty minutes of the first infusion, he experienced intense sensitivity to heat and cold in his mouth, hands, and feet; later, he had cramping and muscle spasms so severe he thought he was having a heart attack.

“John was absolutely miserable,” Roxanne said. Ross quit the infusion after the third dose when an oncologist told him the infusions were only contributing 10 to 15 percent to the effectiveness of the regimen. Five months later, Ross still feels numbness, cold sensitivity and burning in his feet, side effects he said doctors mentioned but “made it seem insignificant.”

So basically, Mr. Ross appears to have been unable to tolerate the infusion anymore but continued the oral chemotherapy and did this:

After that experience, Ross pulled back. He reduced the oral medication, taking six pills daily instead of the prescribed ten.

He also did something else. Early that fall, he switched from ivermectin to fenbendazole, a medication used to treat parasites in animals, which, Dr. James said, he opted to take and obtained himself. Fenbendazole has shown effectiveness in three human cancer cases and in laboratory experiments on ovarian and colon cancer cells.

When the second set of scans were done in November, no cancer was found. Some “high-grade dysplasia,” a cancer precursor, was detected in biopsied cells—a possible outcome, a gastroenterologist told Ross, of the radiation treatments. Doctors want to surgically remove part of the colon, and the Rosses are weighing their options. They are thankful for the chance encounter that led them to Dr. Mollie, as they call her.

It sounds to me as though Mr. Ross was taking oral capecitabine (trade name Xeloda), which is metabolized into 5-fluorouracil, a potent chemotherapeutic agent against colorectal cancer. The number of pills sounds about right, as does the reduction in dose, which is not uncommon. Let’s translate the woo-speak above to more science-based language. Basically, Mr. Ross had an excellent response to two rounds of chemotherapy, with no obvious signs of cancer detectable on colonoscopy after treatment, but he attributes his good fortune to the ivermectin and fenbendazole, along with all the other quackery that Dr. James was “repurposing” to treat him with. Again, as is the case with nearly all alternative cancer cure testimonials, particularly those from patients of cancer quack Dr. Stanislaw Burzynski, the patients and quacks attribute the patient’s good fortune to the quackery and not all the conventional therapy undertaken. In this particular case, the response observed by Mr. Ross is well within the expected range of responses of locally advanced colon cancer to neoadjuvant chemotherapy, no appeal to ivermectin, fenbendazole, or anything else needed.

I only hope that Mr. Ross takes his oncologist’s recommendation and finally does undergo resection of the segment of his colon containing his tumor. If he does, his chances of survival will be quite good; if he does not, his odds of recurrence will be high. Although it irks me a bit, I’ll just accept that, should Mr. Ross undergo surgery and do well, every COVID-19 and cancer quack out there will attribute the outcome to the ivermectin, fembendazole, and all the other quackery to which he was subjected, and not to good, old-fashioned boring “conventional” multimodality treatment of cancer. If the price for Mr. Ross’ survival is that he becomes another Chris Wark, who attributed his survival of locally advanced colon cancer not to the surgery that he underwent but to all the quackery he embraced after surgery, I’m OK with that. I’d rather see a living victim of a quack than one killed by quackery.

But what about the preclinical evidence for ivermectin against cancer?

The post discussed above did mention another patient supposedly “cured” by ivermectin, but there were no details, making it impossible to tell whether there was any plausible treatment effect. However, the post also referred to a recent webinar done for FLCCC by Dr. Ruddy, as well as a number of preclinical studies in cell culture and mice, that suggest that ivermectin has antitumor properties:

Two years before Covid, researchers analyzed published data that strongly suggested ivermectin could be repurposed, namely put to another off-label use, for cancer. In about twenty laboratory studies, ivermectin was found to inhibit cell proliferation and induce “apoptosis”—cell death—in cancer cell lines of the breast, prostate, ovary, head and neck, colon, and pancreas. In six studies in mice, the drug was effective against glioblastoma, leukemia, and breast and colon cancer. Based on these studies, predictions were made that ivermectin could be employed safely and soon.

“The in vitro and in vivo antitumor activities of ivermectin are achieved at concentrations that can be clinically reachable based on the human pharmacokinetic studies,” stated the 2018 article in the American Journal of Cancer Research. “Thus, existing information on ivermectin could allow its rapid move into clinical trials for cancer patients.”

Yes, it’s true. Table 1 shows the possibility. However, I note that the dose needed to achieve these blood concentrations (Table 3 in the paper) is many times higher than the standard dose of ivermectin for roundworm infestations and even then only barely achievable. According to Table 1, for instance, it took 1.4-2.0 mg/kg ivermectin to achieve micromolar levels in vivo, although the highest concentration (Cmax) never surpassed 0.25 μM. We’re talking micromolar (μM) concentrations for most antitumor effects, and a good rule of thumb is that any anticancer pharmaceutical that requires micromolar concentrations and above is going to be a tough sell as an effective cancer agent from a pharmacokinetic standpoint, although in fairness there are a handful of effects observable at 0.1 μM. (The question, of course, is whether these effects would be enough in vivo.). Moreover, large doses are needed in mouse models to achieve an antitumor effect (Table 4).

As for toxicity, the review article notes:

There are several toxicological reports of ivermectin in different species. The lethal dose 50 (LD50) reported in mice [19] is 25 mg/kg administered orally, whose human equivalent dose (HED) is 2.02 mg/kg. The LD50 increases up to 30 mg/kg when this compound is administered intraperitoneally in mice (HED 2.43 mg/kg). For rats the average lethal dose is 50 mg/kg orally (HED 8.01 mg/kg) and 55 mg/kg intraperitoneally (HED 8.91 mg/kg). In rabbits it is 406 mg/kg in topical application, while in dogs it is 80 mg/kg administered orally (HED 43.24 mg/kg) [20]. Clearly, it seems that the higher the phylogenetic scale the lower toxicity by ivermectin. These data are in accord with the findings in a review paper on avermectins poisoning (14 on suicidal attempt). In this retrospective review, among 18 patients exposed to abamectin and one to ivermectin, 15 were poisoned by oral ingestion. Four were asymptomatic and 8 had minor symptoms with a mean ingestion of 23 mg/kg (range in 4.2-67 mg/kg). Seven patients manifested severe symptoms, such as coma (seven), aspiration with respiratory failure (four), and hypotension (three), after a mean ingestion of 100.7 mg/kg avermectin (15.4 mg/kg for ivermectin and 114.9 mg/kg for abamectin). All 7 seven patients received intensive supportive care; 1 patient died 18 days later as a result of multiple organ failure [21].

Let’s, for the moment, accept that a concentration that is potentially effective against cancer is barely achievable in humans at safe doses. Let us even accept that the activity of ivermectin against various cancer cell lines in preclinical models through mechanisms involving promoting apoptosis (programmed cell death), blocking cell cycle, targeting cancer stem cells, and even potentially reversing drug resistance (reviewed in 2021 by Tang et al) is very interesting and suggests that it might be useful as another weapon in our armamentarium against cancer. Far be it from me to discourage repurposing such a drug! In fact, I encourage it, as long as it is done the right way, in a scientifically rigorous manner, which is exactly what FLCCC, Dr. Ruddy, and the various quacks at the five clinics where the study is open are not doing.

In addition, even if all the preclinical data presented is translatable to humans and the drug can be administered safely at a concentration that achieves the biological effects against cancer cells observed in cell culture, it is incredibly unlikely to be effective as monotherapy. This is, of course, a general principle for all putative anticancer drugs, whether new or repurposed. In general, treatment of cancer is multimodality therapy, and even if ivermectin demonstrates clinically useful anticancer effects, it will almost certainly be used in combination with other therapies, be they chemotherapy, targeted therapies, or immunotherapy. If there’s one thing I’ve learned when it comes to repurposing a drug, even one as free of serious side effects as riluzole, it’s that you can never assume that it will remain free of side effects when you combine it with other drugs. Synergistic toxicity can occur. Moreover, the toxicity reported in the review I discussed only looks at single doses of ivermectin. Any cancer drug is going to have to be administered in multiple doses, likely daily, for weeks or even months in order to have a clinical relevant effect. Do Drs. Marik and Ruddy even consider these issues? Of course they don’t, at least not in any of the articles I read.

So I checked out their hour long webinar on the topic, Cancer and Repurposed Drugs, from a couple of weeks ago, featuring an interview with Drs. Marik and Ruddy:

Interestingly, right in the beginning the host mentions the FLCCC Alliance Cancer Care guide. I perused it, and ivermectin was only listed in the “tier two repurposed drugs” with a “weak recommendation,” along with wheatgrass, low dose naltrexone, and captopril. I was amused. I was less amused by her invoking overdiagnosis from mammographic screening as a reason why the death rate from cancer is decreasing; that is, until she showed that she showed that she doesn’t understand what overdiagnosis is by saying that “the pathologists know what they’re doing” and that if they say it’s breast cancer it’s breast cancer. That misunderstands the entire concept of overdiagnosed cancers, which are cancers that, if untreated, are sufficiently indolent that they would never endanger the life of the patient. Then, confused as she appears to be, she seems to understand that overdiagnosed breast cancers “act as though they are benign,” which is nothing more than what Dr. Welch was saying.

Clearly, Dr. Ruddy was tripped up by the term “overdiagnosis.” Basically, she invoked screening as a reason why we might not really be impacting cancer survival. Let’s just say again that I was not impressed, given that the death rate from breast cancer has declined by nearly 40% since 1990. As I’ve explained before, declines in mortality, not increases in 5-year survival, are the true way to tell whether or not we are doing better treating breast cancer, and mortality from breast cancer has declined markedly in the last three decades. Either Dr. Ruddy doesn’t understand this basic principle, or she is misrepresenting it. Of course, it doesn’t help that Dr. Marik leapt in right after her to claim that “the jab” is causing “turbo cancer.” It’s not.

At around the 23 minute mark, they finally get to a discussion of what I was interested in, namely the FLCCC “study.” Hilariously, she likens her effort to the Framingham Heart Study, which was indeed a longitudinal observational study in which participants were regularly interviewed every two years that linked a number of risk factors to heart disease. While she correctly notes that the Framingham Heart Study did find an increased risk of heart disease associated with hormone replacement therapy, she doesn’t mention that this result was different from the results of a number of other studies and that today the preponderance of evidence suggests that hormone replacement therapy’s actions are more complex than just “bad for heart,” with conflicting evidence about timing and effect of hormone replacement therapy that is still debated to this day. In brief and at the risk of oversimplifying, timing of initiation of therapy appears to have major effects on whether it is beneficial or not to cardiovascular health.

Dr. Ruddy also seems to conflate Women’s Health Initiative studies with Framingham, when by bringing in the question of hormone replacement therapy and the risk of breast cancer, she implies that Framingham also found an increased risk of breast cancer associated with estrogen replacement therapy. I suspect that this was more sloppy thinking and talking than lack of knowledge, but maybe I’m giving Dr. Ruddy too much benefit of the doubt. Whatever the case, the question of hormone replacement therapy and the risk of breast cancer is actually more complex than usually discussed. Estrogen replacement alone doesn’t increase the risk of breast cancer—quite the opposite, in fact!—but can’t be given in women who have not undergone hysterectomy because it does increase the risk of endometrial cancer. In contrast, combined estrogen/progesterone replacement does appear to be associated with an increased risk of breast cancer. Unfortunately, Dr. Ruddy oversimplifies to the point of misrepresentation and says that that estrogen causes breast cancer because over two-thirds of breast cancers are estrogen-responsive. And she’s a breast cancer surgeon?

Her stated excuse for not doing a real study is blatantly self-serving as well. Basically, she claims that, because there were consequences for doctors who promoted ivermectin for COVID-19, she didn’t think it would be a good idea to do an actual protocol-driven clinical study of ivermectin for cancer and that an observational study would be better. Of course, I note that there does not appear to be a single person among the persons listed doing the study who might be able to design and run a proper observational study that might answer some of the questions that Dr. Ruddy says that she has: No epidemiologists or biostatisticians, for instance, to determine sample sizes for each endpoint to be examined, just her and her quack buddies. Worse, the study is patient-funded, which is at best ethically dubious and at worst completely unethical. Even in the cases of properly designed clinical trials, it is an ethically fraught question how to have patients fund such trials in a manner that is ethical and does not exploit them. Not for Drs. Ruddy and Marik and their quack buddies are such trivial questions of ethics! They’re brave maverick doctors! Also, the patients want ivermectin, and giving it to them is “empowerment of the patient”! Dr. Marik even says so later in the interview!

I also laughed when Dr. Ruddy said that they were going to look at signals in survival in their “study.” Didn’t she just say that screening and other factors make survival measurements not the best way to determine if we were “winning the war on cancer”? (She did.) Again, survival could very well be affected by selection bias, and there will be a huge self-selection bias for observational study of this sort. This made me cringe mightily later in the interview, when both Drs. Ruddy and Marik went on and on in a a typical conspiratorial fashion (for quacks) about how the profit motive is what maintains the status quo of surgery, chemotherapy, endocrine therapy, and radiation, for cancer treatment. In this, they both sounded just like any other cancer quacks, which, come to think of it, they are.

The bottom line

The FLCCC Alliance is a group of quacks that arose in the era of the pandemic mainly for ideological reasons, specifically opposition to the public health measures instituted to try to mitigate the damage done by COVID-19 before there was a vaccine. Once there was a vaccine, they pivoted effortlessly to being antivaccine. Through it all, they’ve promoted ivermectin and the “repurposing” of their other drugs as part of their “COVID protocols,” because if there are inexpensive and safe treatments for COVID-19, then public health interventions would be unnecessary, as would vaccines. Unfortunately, I’ve observed that it seems to be a general principle that embracing one form of quackery almost always leads doctors down the path to embracing other forms of quackery and becoming just general quacks. This “study” examining the “repurposing” of ivermectin to treat cancer is just the latest example of how the FLCCC Alliance has gone down that path.

Basically, the alternative cancer cure testimonials and shoddy evidence are exactly the same. Only the drugs and “cures” have changed. In the 1970s it was laetrile. Today, thanks to COVID-19 conspiracy theorists, it’s ivermectin and fembendazole.



Posted by David Gorski