If there’s one thing about blogging, day in and day out, over the course of fourteen and a half years, it’s that sometimes you get stuck for a topic. Back in my early days at my not-so-super-secret other blog, I used to be so obsessive that when that happened I’d find something—anything!—to write about, even the end result ended up being not so good. These days, I’ve mellowed considerably. If I don’t have a topic over there on a given day, I don’t sweat it and instead let the topics come to me. Unfortunately, Science-Based Medicine is different. I’m the editor; I’m scheduled every Monday. Writer’s block is not permitted. Usually it’s not a problem, as I have an idea by Friday or Saturday and my post written by Saturday night or Sunday morning, but yesterday morning arrived, and I had no idea what I was going to write about. Then I saw this:
I don't know anything about it, don't recall anyone chatting about it. Let's call some other skeptic MDs too: @gorskon @palmd @HHSkepDoc @ScienceBasedMed @SBMPediatrics Anyone know what this is about? Science based?
— Dr. mem_somerville | Wossamotta U (@mem_somerville) April 28, 2019
It was almost like firing up the Bat Signal!
Even better, the Paddison Program is a treatment that I don’t recall ever having discussed. A search of SBM and my not-so-secret-other blog turned up no mention of this treatment for rheumatoid arthritis (RA). Google searches turned up nothing but the Paddison Program website and lots of laudatory material about the program. So there it was, a dubious-sounding dietary treatment for RA that I hadn’t heard of before and about which there appeared to be very little, if any skeptical material available on the web. Perfect! Let’s take a look!
The Paddison Program
If you peruse the Paddison Program website, you’ll immediately find a number of red flags for quackery and pseudoscience. The site urges readers to “Get Fast And Dramatic Rheumatoid Arthritis Relief With A Proven Step-By-Step System That Is Recommended By Health Professionals”. The entry page for the website is festooned with little other than testimonials. Clicking on the Get The Paddison Program Now leads to a page urging:
Reverse Rheumatoid Arthritis Symptoms With The Paddison Program And Get Your Life Back.
Join over 10,000 others and have less joint pain, less swelling, more mobility and more energy with this unique program.
There’s also a video of a TEDx Talk by Clint Paddison, the inventor of the Paddison Program. (More on that later.) In addition, there are more testimonials. This time the testimonials go further, with people claiming that the Paddison Program allowed them to get off their methotrexate, sulfasalazine, prednisone, and Humira (adalimumab) for their RA, ankylosing spondylitis, etc. Even worse, there are testimonials from physicians, one of whose name I recognized, Dr. Michael Klaper. You might remember him as Penn Jillette’s water fast guru, and his big thing is to advocate vegan diets and extreme fasting as a treatment for, well, almost everything. As for the others, predictably, they ranged from “integrative medicine” doctors (e.g., Dr. Nina Malek, who’s on faculty at the University of Arizona working for Dr. Andrew Weil) to physicians pushing fad diets (Dr. John McDougall and Dr. Monica Aggarwal) to a “chiropractic neurologist” (Dr. Richard Matthews) who specializes in chronic Lyme disease and “brain fog” and appears to be heavily into unproven treatments based on the “gut microbiome.” (Watching his video was painful.)
It gets worse. The Paddison Program website also features glowing recommendations by naturopaths and other chiropractors. Meanwhile, it states:
The standard approach from Rheumatologists is to ‘hit the disease as hard as possible’ with dangerous pharmaceutical drugs that can have side effects that are as bad as the disease itself.
Whilst we must keep the inflammation as low as possible, we should also be addressing the underlying cause so as to stop the disease progression.
This is done by healing the gut (more on this below).
As if the numerous patient testimonials and recommendations by integrative medicine doctors, naturopaths, chiropractors, and purveyors of fad diets weren’t enough in the way of red flags for quackery, we’re now seeing the claim of “addressing the underlying cause” of a disease that is not the underlying cause (as you will see) and the inflammatory (if you’ll excuse the word—I couldn’t resist) characterization of how doctors do treat the disease. If you’re hearing echoes of how cancer quacks characterize cancer treatment as “cut, poison, burn,” you’re not alone. That’s the first thing I thought reading the website. I got the same vibe reading the next segment:
NSAID‘s (like Advil, Voltaren, Nurofen etc) cause digestive issues, quickly exacerbating RA. Taking these drugs usually worsens RA long term.
NSAID damage is so great that they are often accompanied by Proton Pump Inhibitors (PPI’s) which negative impact gut bacteria, cause more RA symptoms.
Clients on antibiotics for RA usually go backwards long term. I see these patients after treatment and they are some of the most difficult clients to help.
Prednisone is exceptionally bad for leaky gut, osteoporosis, vitamin D absorption and more. Long term use is both dangerous and results in worse RA symptoms.
Studies show that RA Sufferers have low levels of healthy bacteria and an overgrowth of pathogenic “unfriendly” bacteria. The more sever the bacterial overgrowth, the more severe your RA is. This bad bacteria, along with undigested food particles, can get into your bloodstream via a leaky gut. Your body sends in antibodies against these particles and creates circulating immune complexes which can get lodged in the joints triggering inflammation. Chronic acidosis, from poor dietary habits, lowers pH levels in the synovial tissue which promotes inflammation. Associated with RA sufferers is low stomach acid, resulting in undigested proteins. When undigested proteins enter the bloodstream the body can develop molecular mimicry, mistaking your own tissue’s proteins for those entering through the gut wall. Studies show that persons with RA have poor intestinal mucosal lining, often worse than that of people with intestinal disease, and some RA folks are lacking an epithelium altogether. This digestive disaster is exacerbated [sic] by low digestive enzymes, further promoting an under active, highly problematic digestive system that needs a massive overhaul.
Paddison even has a cutesy mnemonic for his program: BLAME (Bacteria, Leaky Gut, Acid, Mucosal Lining, Enzymes).
I’ll examine just what Mr. Paddison’s claims entail after I provide a brief primer on rheumatoid arthritis. Here’s his TEDx Talk video, which I will be discussing along the way:
Basically, the video above is Mr. Paddison’s story of his being diagnosed with RA, how it was treated, and how he came up with his protocol. The idea is that RA sufferers can take control of their disease through dietary interventions that alter their gut microbiota. Unfortunately, it’s the illusion of control.
Most readers of the blog probably know that rheumatoid arthritis (RA) is an autoimmune disease that primarily affects the joints. Indeed, RA is the most common type of autoimmune arthritis. It affects more than 1.3 million Americans, about 75% of whom are women. The disease most often manifests itself between the ages of 30 and 50 but can start at any age. Classic symptoms include joint stiffness that is at its worst in the morning (which Mr. Paddington had and related in his talk, as you’ll see). This is in contrast to osteoarthritis, the stiffness and pain of which are usually not more pronounced in the morning. RA often improves with movement of the joints throughout the day. It also most commonly afflicts the joints of the hands, feet, wrists, elbows, knees and ankles, and the joint effect is usually symmetrical; i.e, if one ankle is affected usually the other will be too. Although there is a familial component, with a family history of RA being able to increase the risk of RA three to five times, most patients with RA do not have a family history. (In his video, Mr. Paddington makes a big deal of his not having a family history of RA, which means, really, little or nothing, contrary to his harping on it.)
Other signs and symptoms of RA include fever, loss of energy, loss of appetite, lumps known as rheumatoid nodules that grow beneath the skin in places such as the elbow and hands. Being an autoimmune disease, RA can affect many other organs besides the joints, including:
- Salivary glands
- Nerve tissue
- Bone marrow
- Blood vessels
RA is diagnosed by a combination of physical examination, radiological imaging, and blood tests. Blood tests include tests to look for specific antibodies, inflammation, and anemia. The most well-known of these is an antibody known as rheumatoid factor, which is found in about 80% of patients with RA in time, but as few as 30% when the arthritis starts. Antibodies to cyclic citrullinated peptides (anti-CCP, for short) are found in 60-70% of patients with RA. Erythrocyte sedimentation rate (ESR), a nonspecific indicator of inflammation, is often elevated as well. Some viral infections can cause symptoms that can be mistaken for RA, and false-positive blood tests can occur, so it’s important to be evaluated by a rheumatologist (which Mr. Paddington was).
RA is treated with a combination of drugs. Steroids are sometimes used initially because of their powerful nonspecific anti-inflammatory activity. The mainstay of RA treatment, though, consists of disease-modifying antirheumatic drugs, commonly abbreviated as DMARDs. Common DMARDs include methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine (Azulfidine). Gold and the antibiotics minocycline, azathioprine, and cyclosporine are also DMARDs, but are rarely prescribed for RA these days because of the advent of biological agents used for more severe disease or disease refractory to DMARDs. These include abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), rituximab (Rituxan, MabThera), sarilumab (Kevzara), and tocilizumab (Actemra), all monoclonal antibodies against proteins involved in the inflammation of RA. Usually, ultimately a combination of drugs, including nonsteroidal anti-inflammatory drugs (NSAIDS) are used to treat and control RA.
The concept of remission is important, too, because drug-free remission in RA is possible. It could also explain much of Mr. Paddison’s story. You see, Mr. Paddison came up with his protocol because he himself suffered from RA.
The goal in treating RA is to stop the inflammation and achieve remission, even better, drug-free remission.
Clint Paddison’s story versus science
In his TEDx Talk video, Mr. Paddison provides an engaging story of his RA diagnosis, symptoms, and treatment, describing how this led him to his protocol. Annoyingly, he talks about his “discoveries”, and how they might “provide hope” to others with this crippling disease. He begins by describing how, seven years ago, at the age of 31, he woke up with swelling in his fingers. (The talk is five years ago, which means that Mr. Paddison is now 43.) This happened a few times; so he went to see his GP, who examined him, ordered some blood tests, and diagnosed him with RA, referring him to a rheumatologist.
The rheumatologist, apparently, told Mr. Paddison that the standard approach to RA is to take drugs for the rest of your life. (I noticed immediately how Mr. Paddison led with that, given that it’s a standard talking point in alternative medicine testimonials.) The drug the rheumatologist wanted to start him on methotrexate, a DMARD, but he balked, noting, as I mentioned above, that no one in his family had had RA, plus that he was a young, fit guy, a runner, and more. He also noted that he had been working as a standup comedian (great qualification!), leading him to point out that he only worked a couple of nights a week and should be able to “work it out” on his own. Obviously, you and I see deadly hubris here, but apparently Mr. Paddison did not.
I will admit that the next part of the testimonial did surprise me a bit. Mr. Paddison describes going to see every naturopath, homeopath, Chinese herbalist, acupuncturist, and massage therapist that he could and being on up to ten supplements at a time. None of it worked, and his disease had progressed alarmingly after 18 months of this. One of his elbows had such limited range of motion that he needed surgery, a synovectomy, followed by six weeks of rehabilitation, to restore range of motion. His fingers were so swollen that he couldn’t close his hands into fists. He had chest pain that sounded like pulmonary involvement (pain with every breath), in his jaw, and in many other areas of his body, including his left knee, which had swollen enormously. So, yes, the quackery didn’t work.
I felt bad for Mr. Paddison, as he was in rough shape, but hopeful because he decided to go back to his rheumatologist, who put him on methotrexate, which he took for twelve months. Unfortunately, as is often the case, the methotrexate became less effective. The other problem Mr. Paddison had was that he wanted to have children but because methotrexate is mutagenic you can’t have children while on the drug and in fact have to wait six months. This is what inspired him to come up with his treatment. He also discussed how great he had been as an undergraduate science major. Specifically, he studied physics, and bragged about all the science awards he won (1st Class honours, The Macquarie Foundation Science Prize, Australian Institute of Physics prize, NSW Branch, and Semi-Finalist for Young Australian of the Year) and his one peer-reviewed publication, joking, “If I could do all that, I should be able to kick some rheumatoid butt.” Uh, no. Physics is a very different science than biology, and the skills are not necessarily transferrable. It’s also more hubris to think that you can succeed where generations of immunologists and rheumatologists had failed. I don’t care if, as he claims, Mr. Paddington really did spend the equivalent of a second university degree “studying” RA, especially when his research was guided by books by “the only two people who had ever recovered from this disease” and did it through diet.
Mr. Paddison claims that his great insight was what he calls the “cherry incident,” where he ate a bunch of unwashed cherries, got violently ill for 24 hours, and felt much better, including his joint pain. It’s at this point where he got into all sorts of dietary woo, and related that he felt pain whenever he was full but no pain whenever he was empty. Ultimately, he ended up on a raw food diet, then reintroduced some cooked vegetables. He showed a picture of his left hand before and after, claiming there was nothing wrong with his hand in the “after” photo. I’ll admit that the “after” image looks much better, but his middle finger’s proximal interphalangeal joint still looked quite swollen to me.
Now here’s the kicker. He did this for 24 months, during which time he was still taking methotrexate. As he felt better, eventually he got off of his methotrexate. As an aside, one thing I don’t understand at this point is why the rheumatologist apparently never added another drug or switched Mr. Paddington to a biological agent if he was really doing as poorly as he described at the point right before his “cherry incident”. Something sounds a bit fishy in the story there. Normally what you do when one drug isn’t working as well any more is to add or switch to another.
In any event, let’s move on to BLAME-ing the microbiome.
BLAME the microbiome and diet!
Mr. Paddison came up with his BLAME concept based on his experience. It’s very much a “just-so” story to explain how changes in gut microbiome can lead to damage to the intestinal mucosa, which in turn can lead to “leaky gut“, which leads to antigens getting into the bloodstream undigested, which leads to their triggering autoimmunity through molecular mimicry. Similarly, decreased stomach acid contributes, as do decreases in digestive enzymes, because both contribute to proteins making it to the intestine less digested. It all sounds so reasonable, but is there any evidence?
In a word, sort of. Basically what Mr. Paddison is doing is what so many other alternative medicine and diet mavens do. He’s taking correlative data that hasn’t been firmed up and definitively shown to be part of the pathophysiology of a disease, and extrapolating wildly based on it. For instance, research has been published showing differences in gut microbiota between RA patients and normal controls associated with disease and duration. However, there doesn’t appear (yet) to be good evidence that these are not epiphenomena, that they are causative. More importantly, there isn’t a lot of evidence that dietary interventions to alter the symptoms, pathology, or clinical course of RA. In fact, there’s almost no such evidence that I could find. There’s a study here and there suggesting that specific foods or nutrients affect symptoms. Most are observational or negative. In other words, although it’s certainly possible that the gut microbiome affects RA risk and progression and that dietary manipulation might be a useful adjunct treatment, most of what we know now is preliminary and speculative. Indeed, in this recent review, the microbiome is mentioned, but not as a critical new target for intervention.
None of that, of course, stops Mr. Paddison from building a veritable empire selling his dietary intervention program for RA. He hasn’t, as far as I can tell, published anything in the peer-reviewed medical literature on his program, or verified that his intervention has any significant effect on the gut microbiome at all. All he has are anecdotes. Sure, it’s not unreasonable that decreasing stress would be good for RA symptoms. Sure, it’s possible that dietary interventions might have an effect on the disease symptoms and progression. Unfortunately, Mr. Paddison has done none of the hard work to show any of this. He thinks he has, but he hasn’t. Yet, none of this stops him from selling unproven interventions to desperate patients, even though he is not a physician.
How do I explain Mr. Paddison’s recovery, though?
RA remission: Not as uncommon as you think
The first thing that struck me about Mr. Paddison’s story is how long it was. He spent 18 months after his diagnosis pursuing quackery. He spent twelve months on methotrexate before deciding he had to try something different, and it was two years after that before he got off of his methotrexate. All told, that’s four and a half years, by my estimation, three of which he was on a DMARD, methotrexate. During that time, despite Mr. Paddison’s claims of how poorly he was doing, his rheumatologist never switched drugs, which is very odd if he really was doing so poorly on just methotrexate. Again, most RA patients require more than one DMARD; if Mr. Paddison was doing reasonably well on just methotrexate, it suggests milder disease. Of course, we don’t know why he was never switched to another drug. Maybe he refused. On the other hand, if he was so afraid of methotrexate’s effects on his sperm, you’d think that he would have jumped at the chance to try a different drug.
What I suspect is that Mr. Paddison was fortunate enough to go into remission and that his diet probably had little or nothing to do with it. Indeed, a 2017 review article states, notes that “with new treatment strategies drug-free sustained remission is becoming an achievable goal”. It also cited several studies, dating back to the 1990s, that show that drug-free remissions are not uncommon in disease that is successfully managed with DMARDs:
Once a good response on DMARDs and stable remission are achieved, the treatment could be tapered; and once remission is further sustained, the treatment could be stopped.9 Drug-free remission has been described in several patient groups which supports that drug-free remission could truly be achieved.
The approach of benefit/risk assessment of continuation or stopping DMARDs was examined as early as the 1990s in a double-blind placebo-controlled study.10 In this study, RA patients with a good long-term therapeutic response, after median duration of DMARD therapy of 5 years, were randomized to continue therapy, n = 142, or to receive placebo, n = 143. At 52 weeks of follow up, as many as 62% of the patients who were randomized to placebo and 78% of the patients who were randomized to continue therapy did not have a flare, defined as recurrence of synovitis. Side-effects that necessitated dose reduction or discontinuation occurred equally in each group.
This sounds not unlike Mr. Paddison, who was on his methotrexate three years, at which point he appeared to be in remission. Given that he reported that he wasn’t getting better on methotrexate, another possibility is that he might have undergone spontaneous remission, as described in this review:
Spontaneous remission is not uncommon in patients who present with very early arthritis, some of whom may meet criteria for RA over less than a few months. Spontaneous remission is thought of as a “natural remission,” in which disease activity essentially disappears, and medications are no longer required. Spontaneous remission may be seen in 13% to 55% of individuals presenting with undifferentiated arthritis, probably as a result of different underlying etiologies, such as a transient viral infection . About one third of patients with undifferentiated arthritis go on to develop RA. In a study of three cohorts of recent-onset undifferentiated arthritis from the United Kingdom, Germany, and the Netherlands, the severity of morning stiffness and presence of autoantibodies were the strongest predictors of progression to RA . Spontaneous remission can be seen not only in early undifferentiated arthritis but in RA pregnancy and juvenile idiopathic arthritis (JIA) as well.
So, what’s more likely, that Mr. Paddison cured his RA with a diet that altered his microbiome, a diet that he stumbled across through trial and error, or that he was fortunate enough to undergo remission? Barring compelling evidence, I vote for the latter, but leave open the possibility of the former, although I consider that possibility to be highly unlikely.
What Clint Paddison is really selling
Chronic disease is frustrating. Aside from the symptoms and the impact on quality of life, the patient suffering from a chronic disease like RA suffers from a loss of control. What Clint Paddison is selling, above all, is the same thing a lot of quacks sell: The illusion of control. I realized this when I came across this video:
In this video, a woman asks Paddison how she can eliminate random RA flares. Beginning at 0:45, Paddison goes on an extended discussion of why he never uses the term “flare”, because it implies something beyond the patient’s control. He defines a flare as meaning that a disease is out of our control, that it’s random, and that we can’t do anything about it. He then goes on to argue that RA is almost completely within the patient’s control and that “if we apply a consistent pattern of behavior with our foods—our exercises as well—our stress levels, and also supplementation, then we’re going to get the same outcome with our symptoms” and that “the disease responds to influences that are mostly and largely under our control.”
Holy hubris, Batman! No physician goes that far with almost any disease. Also note that the implication is that this woman is having flares because she’s not doing something right; in other words, her symptoms are her fault. It’s the common quack trope that the treatment doesn’t fail the patient, but the patient fails the treatment, and it’s despicable.
Unfortunately, for patients with a chronic disease like RA, that message of taking control is very seductive. Certainly, it’s that very idea of being able to control his disease himself, without the help of doctors, naturopaths, homeopaths, acupuncturists, etc., that led Mr. Paddison down the path to believing he had found the answer to RA when in reality his story of self-recovery due to his own treatment is dodgy at best when examined critically and his treatment is based on ideas that are speculative at best. If you’re an RA patient, run, don’t walk, from Clint Paddison. He was lucky, not good, and now, sadly, he appears to be descending into the role of charlatan. Stick with science-based treatment.