The Brownstein protocol is not a proven treatment for COVID-19

As we’ve discussed many times before, the COVID-19 pandemic has been a golden opportunity for quacks and grifters and has resulted in a year (and counting) in which even “respectable” doctors have been behaving very badly indeed by spreading COVID-19 disinformation, unproven “miracle cures”, and backing anti-public health activists such as anti-maskers and anti-“lockdown” protesters, so much so that I’ve discussed quite a few of them since COVID-19 was officially declared a pandemic a little over a year ago. Unfortunately, a few of these “brave maverick doctors” are in my area, and one of them has managed to gain some national (and even international) notoriety. His name is Dr. David Brownstein, and he’s promoting yet another unproven treatment for COVID-19, nebulized hydrogen peroxide. I first noticed him promoting this several months ago, but he showed up a week ago on the website of that über-quack of über-quacks, Joe Mercola (the man who, with a net worth upwards of $100 million, is proof positive that quackery pays) in an article entitled “Nebulized Peroxide — A Simple Treatment for COVID-19“, complete with a video clocking in at nearly an hour and a half.

Mercola promotes Brownstein thusly:

Dr. David Brownstein, who has a clinic just outside of Detroit, Michigan, has successfully treated over 200 patients with what has become my favorite intervention for COVID-19 and other upper respiratory infections, namely nebulized hydrogen peroxide.

A peer-reviewed consecutive case series of 107 COVID-19 patients treated with nebulized peroxide and other remedies, including oral vitamins A, C and D, iodine, intravenous hydrogen peroxide and iodine as well as intravenous (IV) vitamin C, along with intramuscular ozone, was published in the July 2020 issue of Science, Public Health Policy, and the Law.¹ All patients survived.

I’ll discuss that publication in a minute, but note the journal. It’s not a journal that would normally publish case series or randomized clinical trials. It’s a medical policy and law journal. Why, one might ask, would someone like Dr. Brownstein choose such a journal? And what of his claim now that he’s up to 220+ patients treated by his protocol without a single death? (Well, almost, as you will see…)

Before we get to that, let’s introduce you to Dr. Brownstein.

Dr. David Brownstein: Promoting alternative medicine in the suburbs of Detroit

I first encountered Dr. Brownstein in 2016, when former SBM blogger, but, more importantly, local internist and primary care doctor, Dr. Peter Lipson, took him to task for complaining about the announcement of age-appropriate vaccine requirements by a Jewish sleepover summer camp in Michigan stating, “No child, camper, staff, artist in residence, volunteer, doctor, nurse, and their families will be allowed to come to camp without documentation of complete immunization according to the policy.” That requirement set Dr. Brownstein off, and he laid down a heapin’ helpin’ of antivaccine misinformation, including the “toxins gambit” in response, leading to Dr. Lipson to call him out on it (and on several other things as well, right here on SBM).

I next encountered Dr. Brownstein throwing a temper tantrum at how difficult it was to recertify for his family practice boards. Basically, he was very unhappy about how it was all about “drugs, drugs, and more drugs” (and vaccines), and bitterly bemoaned how none of the questions were about “nutritional therapies”, “natural treatments”, or the rest of the sort of quackery that he believes in, such as acupuncture, emotional freedom technique, intravenous vitamin and minerals, elimination diets, and more. After that, it was off to the races, with Dr. Brownstein spewing all sorts of antivaccine misinformation about the shingles vaccine, keynoting antivaccine conferences around Michigan, and attacking the New York Times for a pro-vaccine editorial, the last of which was a year before the pandemic hit. So, basically, Dr. Brownstein is the Michigan equivalent of antivaccine physicians like Drs. Lawrence Palevsky, Sherri Tenpenny, Andrew Wakefield, and Dr. Mark Geier. He’s basically the Big Kahuna of antivaxxers in southeast Michigan, maybe of the whole state.

Unsurprisingly, like so many antivaxxers, of late Dr. Brownstein has pivoted to COVID-19 pseudoscience. Indeed, back in May he was warned by the FTC (here’s the warning letter) to stop advertising his “treatment protocols of Vitamins A, C & D, as well as nutritional IV’s, iodine, ozone and nebulization to support the immune system with respect to Coronavirus Diseases 2019 (COVID-19)”. As a result, he’s been discussing his “Plan B“, which was removed from his website, and now is moving on to “Plan C“. Basically, it’s some sort of “study” that was clearly put together in order to get past the part of the letter that warned:

It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product or service can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the products or services identified above. Thus, any Coronavirus-related prevention or treatment claims regarding such products or services are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims.

Which brings us to the “study” by Dr. Brownstein that Mercola touted:

Unsurprisingly, when I first looked at the study last summer, I found its abstract to be singularly unimpressive and, in fact, determined that Dr. Brownstein’s “study” wasn’t even really a study at all, but rather an editorial citing an article by antivaccine “scientist” James Lyons-Weiler. The “study” was retrospective, not randomized, not blinded (much less double blinded), and involved all manner of quackery, including oral vitamins A, C, D, and iodine given to 107 subjects (99%), with intravenous solutions of hydrogen peroxide and Vitamin C given to 32 (30%) and 37 (35%) subjects, 37 patients (35%) of the cohort receiving intramuscular ozone, and a nebulized hydrogen peroxide/saline mixture, with Lugol’s iodine used by 91 (85%). In the article, Dr. Brownstein claimed that 100% of the 107 patients treated recovered, with a high degree of rapid symptomatic improvement. It was the very definition of an utterly uninformative study, even less informative than Didier Raoult’s awful studies. Will Dr. Brownstein be able to deliver anything better this time? Let’s find out, but I suspect you know the answer.

Let’s just say that this time around he’s claiming that early treatment with his protocol can eliminate COVID-19 “long haul syndrome”, basically a poorly defined, not yet well characterized constellation of symptoms that persist after a patient recovers from a bout of COVID-19. Indeed, a study published last month in JAMA Network Open reported that at 6 months after COVID-19 infection, over 30% of adults were still having “long haul” symptoms, including fatigue, persistent loss of smell or taste, “brain fog”, and other symptoms. Interestingly, there are preliminary reports of patients with “long haul” COVID-19 symptoms improving after receiving a COVID-19 vaccine. I’m not yet convinced that this is more than a placebo effect, but it’s intriguing, as this Twitter thread by Prof. Akiko Iwasaki at Yale University suggests:

Back when I first learned about #longcovid in June 2020, I proposed 3 possible mechanisms.
1) Persisten viral reservoir
2) Viral fragments/remnants (RNA, protein) 'viral ghost’ driving inflammation
3) Autoimmune response induced by the infection (2/)https://t.co/KilBUcnA2e

— Prof. Akiko Iwasaki (@VirusesImmunity) February 28, 2021

Funny how Dr. Brownstein is apparently not interested in this hypothesis. Long haul COVID-19 is a fascinating phenomenon, a worthy topic for its own post. I fear that “COVID long haulers” will be ripe targets for the sort of quackery that doctors like Drs. Mercola and Brownstein offer. In the meantime, let’s look at what Dr. Brownstein is saying now.

Dr. Brownstein curing COVID-19? Not so fast there…

So now that Dr. Brownstein’s “case series” (such as it is) has reached 230 patients according to him, you’d think he’d be ready to publish in a reputable journal, or at least to attempt to do so. You’d be wrong. Instead, he’s publishing a book (of course!), so that he doesn’t have to deal with all that pesky peer review. The title? A Holistic Approach to Viruses, and it comes with a strong recommendation by Robert F. Kennedy, Jr., as fantastic an indication that there can be that it’s utter antivaccine nonsense, particularly how he says, “Dr Brownstein gives us the recipe for bolstering the most powerful and successful vaccine ever devised- the human immune system.” The book’s promotional blurb is similar:

COVID-19 should be a wakeup call for all Americans. The carnage it has caused did not have to occur. Moving forward let us make sure nothing like this happens again. You can rest assured that other viruses will be around in the future. The way to combat these pathogens resides within us- a strong, well-supported immune system.

Of course, no one in “conventional medicine” is saying that general health isn’t important when it comes to determining your resistance to pathogenic viruses and bacteria. However, I get a very strong germ theory denial vibe like so many other examples that I’ve seen before from this whole passage. Dr. Brownstein’s idea is apparently that you can “boost” your immune system with vitamins, iodine, and hydrogen peroxide in order to fight off SARS-CoV-2, the coronavirus that causes COVID-19, as well as viruses that cause the flu and other illnesses. Basically, the idea is that you don’t need vaccines if you only just live the right lifestyle, eat the right foods, and take the right vitamins and supplements.

So what does his treatment consist of? According to his “case series”, this is the protocol:

• Vitamin A: 100,000 IU/day*** in the form of emulsified Vitamin A palmitate
• Vitamin C: 1,000 mg/hour while awake in the form of ascorbic acid until bowel tolerance (loose stools) was reached
• Vitamin D3: 50,000 IU/day in an emulsified form
• Iodine: 25 mg/day in the form of Lugol’s solution or tableted Lugol’s solution

And:

Most patients were instructed to nebulize a dilute solution of 0.04% hydrogen peroxide in normal saline. The solution was mixed for the patient in the office. A sterile 250 cc bag of normal saline was injected with 3 cc of 3% food grade hydrogen per- oxide and 1 cc of magnesium sulfate. The patient was instructed to draw off 3 cc of the dilute solution and nebulize it hourly until symptoms improve. Additionally, the patient was instructed to add in one drop of 5% Lugol’s solution to the dilute hydrogen peroxide mixture. As the symptoms improved, the frequency of nebulizing could be reduced by the patient. If symptoms worsened or there was a concern that the patient was suffering from a more severe case, the patient was advised to come to the office and receive intravenous injections of Vitamin C and hydrogen peroxide along with intramuscular injections of ozone.

If the vitamin C and ozone were necessary, this is how Dr. Brownstein would administer them:

• Vitamin C: 2.5 grams of sodium ascorbate (5 cc of a 500 mg/cc ascorbic acid solution) mixed with an equal amount of sterile water given as an intravenous push over 2-3 minutes.
• Hydrogen peroxide: 30 cc of a 0.03% solution of dilute hydrogen peroxide given as an intravenous push over 2-3 minutes.
• Ozone: 20 cc of 18 mcg/cc ozone (as an oxygen/ozone gas mixture) given in each buttock as an intramuscular injection.

Intramuscular ozone injections in the buttocks? Ouch! As for the hydrogen peroxide solution, a 0.03-0.04% solution is only a 3-4:10,000 solution, so very dilute that it’s doubtful that it could have any therapeutic effect. Certainly, it’s not going to kill much virus, given that the virus that’s causing the problem is mostly already in the cells lining the lungs, happily replicating and then bursting out to infect more cells. Although they don’t talk about the rationale much, I refer back to Dr. Mercola touting nebulized hydrogen peroxide way back in April:

Your immune cells actually produce hydrogen peroxide. This is in part how your immune system kills cells that have been infected with a virus. By killing the infected cell, viral reproduction is stopped. So, hydrogen peroxide therapy is in essence only aiding your immune cells to perform their natural function more effectively.

It is indeed true that some immune cells use hydrogen peroxide to kill cells infected with virus. But guess what? There’s a huge difference between immune cells generating small amounts of peroxide that can result in very high concentrations locally that are sufficient to kill infected cells and either injecting or inhaling nebulized hydrogen peroxide. In his article from nearly a year ago, Mercola listed a bunch of studies that demonstrate that nebulized hydrogen peroxide can kill viruses on surfaces and thereby disinfect them. That’s no big surprise, it’s a strong oxidizing agent. Its ability to kill viruses on inanimate surfaces does not mean that it’s a good treatment to kill virus in your lungs.

These days, the protocol seems to have evolved. Dr. Brownstein was very big on adding Lugol’s iodine solution to the nebulized hydrogen peroxide:

And then maybe a few years after that, hydrogen peroxide came in my window. That one, I was a little leery about, using an IV (intravenous) or nebulize, just because, I couldn’t wrap my head around, “How am I going to use this oxidative therapy? Isn’t that going to make people worse?” But the more I learned about hydrogen peroxide and it’s produced every cell in the body, it’s produced in huge amounts throughout the body, every second, every minute, every day, I started using IV and nebulized peroxide and I mixed the nebulized peroxide with a nebulized iodine in one solution. And that really was a cool addition, for people who were developing lung problems or pneumonia or lung cancer or COPD (chronic obstructive pulmonary disease), coughing, and they can’t breathe and they’re wheezing and things like that, adding a nebulized dilute solution of hydrogen peroxide at 0.04% and one drop of 5% Lugol’s solution, which supplies 6.25 milligrams of iodine really helped a lot of people out.

There really is no good basis in basic or clinical science to use these interventions to treat COVID-19 patients. Certainly, Dr. Brownstein, for all his reading, can’t produce any, nor can Dr. Mercola. As for “really helping people out,” how does he know? How does he know that nebulized normal saline wouldn’t have produced exactly the same effect? He doesn’t, because there are no trials. Certainly, his “retrospective” trial shows nothing. Indeed, he uses that as an excuse, at one point in the interview saying:

But there are a lot of people who have died because the governments and the powers that be, and the AMA (American Medical Association) and everybody else out there has said, “There’s nothing you can offer and don’t offer anything because it hasn’t been randomized, double blind, placebo-controlled, therefore, you can’t do it. And if doctors do it, we’re going to censor them and hold them accountable.” And that’s been the biggest disaster of this whole thing.

That might have been a (somewhat) reasonable thing to say in March 2020. I say “somewhat” because people were dying and we knew little about the novel coronavirus that was ravaging the world, including whether the treatments tried without randomized clinical trials would help or hurt. When people are dying, doctors will try things before there are randomized clinical trials testing them, just out of sheer desperation. Here’s the problem, and I’ll bring you back to the example of HCQ again. It looked as though it might have promise very early on, but it didn’t take long before science showed that it doesn’t work against COVID-19. A year later, Dr. Brownstein’s statement is no longer even semi-reasonable, as there have been a large number of randomized trials on various COVID-19 treatments. We now have an idea of a few things that (probably) work and a lot of things that definitely don’t. In light of that history, Dr. Brownstein’s statement comes across to me as just another excuse to keep using unproven treatments on COVID-19 patients. Unsurprisingly, Mercola is totally in agreement with this excuse and even responds by parroting two myths about COVID-19: first, that the case number is vastly inflated (which is one he’s promoted before) and that most people die of their comorbidities with COVID-19, not of COVID-19. It’s a form of COVID-19 disinformation that I like to call the “6% gambit” because it claims that only 6% of deaths attributed to COVID-19 were actually due to SARS-CoV-2 and that the rest were due to comorbidities.

And on what basis does Dr. Brownstein base his assessment that his treatment is effective against COVID-19? Anecdotes, straight from his book:

“[Among] our [COVID-19] patients, we’ve had no deaths,” he says. “We’ve had a couple of hospitalizations, but much smaller than should be for the reported statistics. And we’re still using the same protocol we’ve been using for 25 plus years for flu and flu-like illnesses.

A patient I called over the weekend told me ‘There are two things out of what you gave me that I could tell really made me feel better.’ I gave him the whole protocol of oral vitamin A, C, D and iodine and nebulized peroxide and iodine.

He said, ‘I forgot to use the iodine the first day or two. When you asked me about it, I re-added it back in orally. That made the difference. My mucus thinned out, my breathing was better. I forgot to put the iodine in the nebulizer [too], and [when] I did both at the same time — the oral iodine and the nebulized hydrogen peroxide with iodine — everything cleared up …’

His breathing was 80%, 90% better shortly after the first or second dose of iodine. He’s another success story that we’ve had, which is supporting people’s immune systems during these viral illness times … I would implore my colleagues to add iodine into whatever regimen you’re using to treating patients who are ill with flu-like illnesses such as COVID-19.”

Now here’s the thing. Dr. Brownstein’s practice, his Center for Holistic Medicine, is located in West Bloomfield, a wealthy suburb northwest of Detroit. (Its median household income is nearly $102,000, compared to the US as a whole at $57,700.) Dr. Brownstein caters to well-off suburbanites with a love of woo. As a result, it is not surprising that he could have had 107 COVID-19 patients without a single death for a virus with a relatively low case fatality rate. It’s not even surprising that he might reach 230 patients without a single death (that he knows about). For one thing, he’s almost certainly seeing mainly mild cases of COVID-19, patients who do not require hospitalization.

Similarly, he’s very selective about whom he includes on his “trial”. They have to be patients in his practice. Remember how I said “almost” about Dr. Brownstein’s claim that he had no deaths? Or maybe I should have said “not quite”:

Dr. Joseph Mercola:
And I wonder what your experience has been, because my guess is that most of the patients you’re seeing are very early on. You’re not seeing people who have just been lingering out there and not knowing what to do.

Dr. David Brownstein:
That’s true. We’ve had a few patients referred to us, who weren’t our patients, and they were sick for a long period of time before they came to us. And out of our patients, the numbers hold true.

We had one patient die who was referred to us after he was sick for almost two weeks. And he was in his late 80s, got a bunch of comorbidities. And my partner treated him for two days and he died on the second day of his treatment. That was the only blemish in our protocol, but out of our patients who started early, we have very few hospitalizations, no deaths. And I would agree with Dr. Zelenko. Long-haulers are rarely minimal. When I looked at the first 107 patients, the long-haulers were 2%, now the reported numbers of them are somewhere averaging between 25% and 40% are developing long-haul symptoms. And that less than 5% number hasn’t changed with the next 150 or so patients that we’ve treated with it.

Yep. As I predicted. Dr. Brownstein and his practice are seeing the mild patients, and the patients he sees who don’t have mild cases he’s leaving out of his “case series” because they “weren’t our patients” initially. This makes me wonder how truly “consecutive” his “consecutive” case series is, now that it’s supposedly up to 230 or so patients. I also wonder why it took him so long to accumulate 230 patients. He has a large practice and accumulated 107 patients between February and May (four months), but it took him another eight months to gather another 123 patients? That is…odd. Moreover, his first 107 patients were reportedly diagnosed either via PCR or antibody testing but also included “those not tested diagnosed via symptomatology,” and I have to wonder about February given that the first two cases of COVID-19 in Michigan were not confirmed until March 10, 2020. The more I look at this “study”, the more odd things I find about it.

As for Dr. Zelenko, you might remember him. He’s still around and still promoting hydroxychloroquine (HCQ), even though there are now multiple randomized clinical trials showing that it doesn’t work against COVID-19. I once referred to HCQ as the “Black Knight of COVID-19 treatments“. Nothing has happened since then to change my mind about that or my opinion that Dr. Zelenko is a self-aggrandizing quack.

There is no evidence that inhaled hydrogen peroxide either treats or cures COVID-19, and nebulized mists of it are corrosive and can irritate and damage the mucus membranes and the airways, something that’s definitely not a good idea to subject the lungs to if you have COVID-19. Nor is there any good evidence that anything else that Dr. Brownstein does in his COVID-19 protocol is beneficial, with the possible exception of vitamin D therapy (although recent clinical evidence has not been encouraging even for vitamin D).

One year in, too much and not enough have changed

Last week marked the one-year anniversary since the World Health Organization officially declared COVID-19 a pandemic. Much has changed since then. What has changed greatly is that we now have at least three safe and effective vaccines available in the US, with more likely to come and an administration that actually supports science-based public health measures. Unfortunately, another change is the emergence of SARS-CoV-2 variants that are more transmissible (and possibly more virulent) against which current vaccines might be less effective, leaving us in a race to vaccinate as many people as possible before variants emerge that can evade the immunity produced by vaccines. What hasn’t changed is the paucity of effective treatments. Unfortunately, what also hasn’t changed are the intransigence of the antivaccine movement, which has pivoted to demonize COVID-19 vaccines even as it’s embraced QAnon conspiracy theories, and the proliferation of unproven and downright quacky treatments for the disease, along with the conspiracy theories that “they” are keeping the “cure” for COVID-19 from you. Dr. Brownstein and Dr. Mercola epitomize that.