Sniffing Out Bullsh*t

Someone who cares about me and my health mentioned a new product.

“Hey did you hear about the Harvard Medical School nasal spray made of generally-recognized-as-safe ingredients that is 99% effective at protecting against flu and COVID?” 

“No,” I said. “Where was that?”

“I saw it in my Apple News feed… let’s see, Google for ‘Harvard nasal…’ yep, Google says this is a common search. Here it is. Harvard Nasal Spray.”

So what is it? On September 25, 2024, the Harvard Gazette published a story called “Drug-free nasal spray blocks, neutralizes viruses, bacteria. In preclinical studies, spray offered nearly 100% protection from respiratory infections by COVID-19, influenza, viruses, and pneumonia-causing bacteria.” The article was written by BWH (Brigham and Women’s Hospital) Communications. It was a glossy, illustrated article, no doubt reflecting a press release announcing the publication one day earlier of a scientific article in the journal Advanced Materials. With 25 co-authors, most from one or another department of Harvard Medical School, and many also from the “Center for Accelerated Medical Innovation” of the Anesthesiology Department, the scientific article introduced a new “Pathogen Capture and Neutralizing Spray which… [serves] as a physical barrier against a broad spectrum of viruses and bacteria, while rapidly neutralizing them with over 99.99% effectiveness.” Four of the authors, including the two senior authors, were disclosed to have a conflict of interest because of their ownership in a commercialized product through a company they founded called Akita Biosciences.

No bullsh*t — the scientific article is impressive. It reports a series of experiments in various models of how we catch the flu. The models used to test the spray included a little plastic gizmo, a preparation of sheep intestinal lining, some computer models of organic molecules, some cultured human nose-lining cells, and an experiment with some mice who received either the new spray, or a placebo, before having a dose of flu virus shot up their noses. The mice who got placebo died within 5 days. The mice who got the new “Pathogen Capture and Neutralizing Spray” died too, but some of them lasted 9 days.

As a physician-scientist who has been involved with dozens of so-called “translational medicine” projects, where a new idea from the laboratory is studied along a pathway of experimental testing with the goal of turning it into a safe and effective commercial product, I read this article and thought it seemed like a great piece of work, the development of something which might prove useful. On the other hand, anyone who has tried their hand at developing new drugs, devices, or treatments for human conditions is likely to know countless stories of new therapies that seemed to make sense, and indeed worked out well in pre-clinical studies, but which turned out when tested in humans to be ineffective or to have unintended adverse effects.

In this case, however, the Harvard Center seems to mean it when they chose the name “for Accelerated Medical Innovation,” accelerating straight to the marketplace. Two days later, Market Watch tweeted: “Harvard scientists say this $25 nasal spray beats flu, colds and COVID-19 with 99% success.”

Akita Biosciences, the company co-founded by the two doctors, had announced its launch almost a year earlier, with plans for a single initial product, a nasal spray called Profi. On September 31, 2024, Profi spray was shown on Amazon as sold-out. But it’s for sale online from profispray.com, a very nice-looking website (registered in early 2023) where testimonials and five-star reviews scroll past. One, from “Dr. Dave Rabin, Chief Medical Officer & Co-Founder” says :

“This is such a thoughtfully designed and effective product! As a physician, I recommend this to all of my patients. Kudos to Dr. Jeff and the team.”

You get the picture. A very fast path from an idea, a patent, a company, a product, and some benchtop scientific laboratory experiments. A university hospital innovation accelerator. A hospital communications team placing articles which, while not exactly dishonest, certainly make it seem like, you know… “Harvard scientists say this $25 nasal spray beats flu, colds and COVID-19 with 99% success.”

Let’s do a thought experiment. How would you go about proving that a nasal spray prevents those respiratory virus infections in humans, that it is both safe and effective? The answer is that it would take a large clinical trial. A lot of time, money, oversight for the safety of the participating human subjects, and a way to tell that the humans who used the spray almost never ever caught a cold, while the humans who didn’t use the spray got the normal amount of viral infections.

The guys behind Profi did not do that.

Instead, they have started selling a product using the well-known dodge from the supplements industry: they almost almost almost make claims that it is a good product for humans to ingest. But they don’t quite make an explicit claim (at least, not in the company’s own sales material) that it is effective, or even safe. They use testimonials, and scientific-sounding descriptions of the purported mechanism of action. They use their hospital’s communications department; the algorithms of Apple News that pick up and spread preposterous claims; and Market Watch’s Twitter account to do a lot of the work for them.

Let’s do another thought experiment. Imagine that a proper clinical trial was done, and that when all the results were tallied, there was no difference in the rate of flu infection between the human subjects who squirted the Pathogen Capture and Neutralizing Spray and the subjects who squirted an identical-appearing placebo spray. What might explain the results if that large clinical trial did not produce the results that Profi’s founders hoped for? Maybe it’s that many viruses infect humans through the lining not only of the nose, but also the windpipe, the lungs, and the eyes. Maybe it’s that the thickness of coating of gel is quite thick relative to the size of a mouse’s nose, but not nearly so thick relative to our big honkers. Maybe mice noses don’t wash out the gel, but runny sneezy human noses do. Maybe, just maybe the gel actually does reduce virus infections in humans (though not by 99%), but also unfortunately causes a serious inflammatory reaction in the lungs of just 1% of the people who use it. If that was the case, the product would not be likely to be permitted to be sold as a drug or medical device.

So, the reasoning goes, let’s not find out. We can start selling it. People have a right to try it. People should be able to take our nifty new formulation of “generally recognized as safe” stuff and squirt it up their noses.

The line between peoples’ right to try things and the interest in protecting people from manipulative salesmen is often not a line, but a wide gray zone. The scientific article did, after all, disclose that some of the authors had a conflict of interest. And the company’s website didn’t exactly say it was a medicine, or a therapy that worked. It just said that people are saying it really works. That this doctor (who works for us) recommends it for all his patients.

I hope the Harvard nasal spray works. But at this rate, we will never know. Especially if the company starts to make money by selling the stuff! In that case, why should they risk finding out that it doesn’t work? They are not going to do the long, hard, expensive study needed to figure it out, and possibly shoot themselves in the foot by showing that the product is not effective, or even not safe. And because it’s not being sold as an FDA-regulated drug, the FDA is not going to analyze their results -- I’d bet they won’t be getting any.