Gain of function research needs to be banned, but we need to define it properly

I’ve been writing about dangerous gain-of-function research on viruses for years, originally on the flu virus and more recently on the Covid-19 virus. Many people are deeply concerned about this research, which might have caused the Covid-19 pandemic, and yet there are still no real regulations controlling it, neither in the U.S. nor anywhere else.

I can already hear the objections: oh, but what about the new rules that NIH put in place in 2017, after a 3-year “pause” in some gain-of-function (GoF) research? Those rules were utterly ineffective, but I’ll get to that in a minute.

Despite my arguments, and the concerns of many other scientists, which have been expressed in various forums and articles for at least a decade now, the virology community continues to insist that any limits on GoF are unnecessary, and that GoF is wonderfully beneficial. A group of 156 virologists even wrote an opinion piece, published in the Journal of Virology, making this very point.

I’ve tried to convince some of my colleagues in the infectious disease world that GoF should be banned, and I’ve discovered that many of them–even some non-virologists–are opposed to any government regulation of GoF research.

They are wrong. However, they do raise one important concern that I think is valid, and that I will address in this column. Their concern is that any government regulation will be ham-handed, and will likely end up limiting or preventing a range of very useful experiments that have the potential to lead to beneficial new drugs and vaccines.

I get it. When the government tries to regulate science, it can write rules that are far too broad, or that get mis-interpreted even if well-written, and unintended consequences follow. So let’s not do that: below I’ll explain what I think needs to be banned.

But let’s not forget why we are having this debate right now: there is a very real possibility that the Covid-19 pandemic started in a lab that was doing GoF research on coronaviruses. We know that the Wuhan Institute of Virology (WIV) was doing this kind of research–that fact is not under dispute. We don’t know (and we may never know) if the original Covid-19 virus first appeared as a result of a lab leak, but it might have. That’s why we’re asking whether such research is worth the risk.

Before I explain what I think the rules should be, let’s look at the current NIH rules, which I mentioned above. First, though, let’s remember that NIH rules only apply to research funded by NIH. Research that is funded privately, or by any other part of the government, is unaffected by these rules and remains entirely unregulated.

So: back in 2017, when the NIH lifted the 3-year funding pause, they put in place some rules (detailed here) for work on “potential pandemic pathogens,” or PPPs. (The government loves acronyms.)

The pause itself was prompted by work on avian influenza, led by virologists Ron Fouchier and Yoshihiro Kawaoka, that was designed to turn some deadly bird flu viruses into human flu viruses. The work was successful: the researchers did indeed create viruses that had the potential to infect humans. These results were really alarming to many scientists: I wrote about it at the time, and other scientists also raised the alarm. Those concerns are what led to the funding pause.

Since 2017 then, the NIH regulates (but doesn’t ban) research on PPPs that are both:

1. “likely highly transmissible and likely capable of wide and uncontrollable spread in human populations, and
2. likely highly virulent and likely to cause significant morbidity and/or mortality in humans.”

One of the first things to notice about this definition is that avian influenza–the very work that prompted the new rules–isn’t really covered.

Another thing to notice is that work on coronaviruses in bats–the GoF work that was apparently going on in the Wuhan Institute of Virology, and that may have caused the Covid-19 pandemic–wouldn’t have been covered either. Those bat viruses would not have been considered “likely highly transmissible in humans,” not before the pandemic.

Of course, we all know differently now.

In any case, the rules that NIH introduced in 2017 only applied to a very narrow class of work, and as far as I can tell, they didn’t restrict anything. On the contrary: the NIH resumed funding the GoF work on avian influenza work by Fouchier and Kawaoka soon after lifting the funding pause. And let’s not forget that NIH rules aren’t a ban: it remains perfectly legal to do any kind of GoF work.

So how can we put in place intelligent restrictions that will prevent dangerous GoF research in the future?

First, rather than rejecting any restrictions whatsoever, as some virologists have done, scientists should work with the government to craft a thoughtful set of limitations. For starters:

1. Research that creates new strains of the Covid virus (SARS-CoV-2) that might have greater virulence or transmissibility should be entirely banned.
2. Research that takes non-human viruses, including avian flu and bat coronaviruses, and gives them the ability to infect any new animals, should be banned.

To scientists who can’t even agree on these restrictions, I would say that it appears you oppose any restrictions whatsoever. If that’s your position, then the government might step in and impose far broader bans, which are not likely to be good. If you’ll agree to these two restrictions, perhaps we can broaden them slightly to cover other types of highly risky GoF work.

Finally, let me return to a point I’ve made before, but that bears repeating: the supposed benefits of GoF research are essentially zero. The claim that GoF research that makes a virus more deadly will help us “understand pathogenicity” or “be prepared for the next pandemic” are just hand-waving arguments. I wrote a whole column just last month explaining why these claims are fundamentally wrong, so I won’t repeat that here.

If we do ban some GoF research, with carefully-crafted rules, we won’t lose anything. Instead, we’ll gain at least two things: first, virologists can apply their expertise to truly beneficial virology work, and second, the scientific community will regain some of the trust it has lost during the pandemic. That would seem like a good thing.

Herbal extracts that cure an enlarged prostate? Not likely.

Saw palmetto, which is NOT effective for

treating enlarged prostates.

(Note: see the brief update at the bottom of this post for a response from the manufacturer.)

I haven’t looked at medical scams recently, and I thought I’d venture back into that world just a little bit this week, to see what is happening.

As always, the scams are everywhere, with products claiming to cure just about everything. What surprised me, though, is how blatant some of them have become. Some sites have no caveats or disclaimers at all, despite the fact that their claims are utterly false. They don’t even pretend that they are worried about a regulatory agency objecting to their false claims. The boldness can be startling–or, if you’re not sufficiently skeptical, convincing.

Let’s look at one site that strikes me as particularly egregious, which sells a dietary supplement called Prostoxalen as a cure for prostate problems. I was directed to this site by another site, ShopBodyVibes, that sells an even wider range of bogus cures (more on that below).

The marketers of Prostoxalen, which they sell for $40 for a bottle of 60 pills, are nothing if not direct. At the top of their website, they promise that Prostoxalen will “get rid of the constant pressure on the bladder, unpleasant pain and all other ailments related to prostate enlargement! Once and for all!”

Nowhere do they provide even a shred of evidence for this claim.

And there’s more: they also claim that Prostoxalen will cure erectile dysfunction: “if you've noticed erection problems, our capsules will fix that issue as well,” the site states.

Again, no evidence at all.

I was expecting at least a citation to a poorly-done study published in a low-quality journal - after all, even homeopathic treatments, which are laughably ineffective, can find some bad science to support their claims.

But no, not for Prostoxalen. Maybe its marketers think that the testimonials alone (which appear to be fake) are sufficient.

So what on earth is in these pills? Well, it turns out that they’re just plant extracts and vitamins. The main ingredients are extracts of saw palmetto, pumpkin seeds, cranberries, tomatoes, nettles, and willowherb, along with a couple of common vitamins.

Great! So all you need is cranberries, tomatoes, and pumpkin seeds, and your prostate problems will go away. I’m surprised that anyone has an enlarged prostate, if this is all it takes to cure it.

But here’s the problem: there is no good scientific evidence that any of these ingredients will cure or relieve the symptoms of enlarged prostate. Not even a tiny bit.

(If you want to dig deeper, you can find multiple scientific studies of saw palmetto, which is widely marketed as a treatment for enlarged prostates. A carefully-done randomized trial out of Washington University, back in 2013, show that it simply doesn’t work, even at high doses.)

The name Prostoxalen sounds just a little bit like they might want you to think it’s a drug, doesn’t it? Maybe something to do with the prostate? Fortunately, the website answers this question in a FAQ list, which says: “No, Prostoxalen is not a drug. It is a food supplement in the form of capsules.”

Aha, that explains it. Dietary supplements aren’t regulated by the FDA, unless you claim that they’re a drug or that they can treat a medical condition.

What I expected to see on the website, but didn’t, was this disclaimer: “these statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” That’s the small-print language that appears on thousands of websites and products, and that allows supplement makers to make all kinds of hints and suggestions while avoiding regulation. Typically they use phrases like “supports prostate health,” as one saw palmetto product puts it.

It appears that Prostoxalen is manufactured and sold by a company in Poland, identified on the website only as PLT Group. So I guess they just don’t care what the FDA thinks–even though they are marketing this in the U.S. (I contacted them through their website, but they didn’t respond.)

So no, there is no magic pill that cures or relieves the symptoms of enlarged prostates, and any such cure is almost certain to require more than a few plant extracts.

Finally, about that site that directed me to Prostoxalen: that was ShopBodyVibes, a site that sells products to “make the penis longer” (Eroxel), “cleanse the body of toxins” (BurnBooster), “reduce varicose veins” (Variforce), “eliminate knee pain” (Ortezan), and a “breast enlargement serum” called BooUp. I’m not making this up. Needless to say (but I’ll say it), none of these products works–and yet the site has no disclaimers, nor does it provide any evidence for the claims.

The ShopBodyVibes site repeats all the claims from the Prostoxalen website (see here), again with no disclaimers. If you wonder what is in this product, (as I did), ShopBodyVibes suggests that “Everyone who is interested in learning the detailed composition of the product can read the list of ingredients, which is available on the manufacturer’s official website.”

Perhaps unsurprisingly, the ShopBodyVibes site has no indication of where it is located. It appears to be outside the U.S., which explains its stunning lack of any attempt to qualify its many bogus claims. It also has enough similarity to the Prostoxalen site to suggest that both sites might be owned by the same group in Poland. They didn’t respond to my inquiries.

And if you’re wondering how I stumbled upon BodyVibes: they were promoted by an article on Goop (yes, that’s Gwyneth Paltrow’s lifestyle company) about “wearable stickers that promote healing.” Yes, BodyVibes sells those too. I wrote about these magic stickers back in 2017, and my advice then still applies: they still don’t work, but if you like stickers, you can get a sheet of 50 for a couple of bucks.

Update: the manufacturer of Prostoxalen replied to my inquiry after this post appeared. Their message, in full, said: “our product has passed all the required tests before being launched on the market. It has proven to be highly effective, safe and legally introduced. We are a Polish company - the product is on the list of the National Sanitary Inspectorate at the Ministry of Health in Poland.” They did not provide any evidence or citations to support these claims, particularly the “highly effective” claim.