The FDA needs to approve the COVID-19 vaccines. Right now.

I’ve spent untold hours fighting bureaucracy during the course of my life. Sometimes the issues are big, sometimes small, but I often get incredibly frustrated when I see organizations–and the people who work for them–enforcing rules without thinking, often to the detriment of everyone involved.

Usually, though, bureaucratic rules are little more than annoying time-wasters. They don’t usually cause actual harm to people. Right now, though, the FDA’s failure to fully approve the Covid-19 vaccines, and its rigid adherence to its own rules, is not just wasting time. It’s killing people, albeit indirectly.

The FDA needs to approve the Covid-19 vaccines, and they need to do it now. They claim to be working hard on doing just that. The vaccines have already been administered to hundreds of millions of people, and the ones used in the U.S. and Europe have proven to be remarkably safe and amazingly effective. So what is the FDA waiting for? Well, according to them, they have to wade through the paperwork.

As nearly everyone knows, here in the U.S. we have three approved vaccines against SARS-CoV-2, from Pfizer-BioNTech, Moderna, and Johnson & Johnson. The first two are messenger RNA (mRNA) vaccines, an innovative design that is strikingly effective, reducing the chance of infection by over 90%.

The U.S. now has an ample supply of vaccines, but we are struggling to get everyone vaccinated, in large part because so many people are either hesitant to get the vaccine or downright opposed. Let’s leave aside the blatant anti-vaxxers for today, many of whom are so deeply misinformed that changing their minds is probably impossible.

A much bigger problem, and one that we can fix, is the far larger number of people who are waiting for the vaccines to get full FDA approval. Not only are many individuals waiting, but many large institutions, including the U.S. Defense Department, have announced that they will mandate vaccines for their personnel once the FDA formally approves them.

Right now, the 3 vaccines in the U.S. are only conditionally approved, under the FDA’s Emergency Use Authorization (EUA). The fact sheet that the FDA provides with these vaccines includes a number of caveats, and states that “there is no FDA approved vaccine to prevent Covid-19.” That statement is not, to put it mildly, very convincing.

Full approval requires the FDA to review “hundreds of thousands of pages of documents,” a process that usually takes 10 months, or maybe six months for a “priority” application. Pfizer only submitted its paperwork on May 7, and Moderna on June 1, so even the FDA’s priority process would leave us without an approved vaccine until the end of 2021. That’s just too long.

I’ve heard the FDA’s excuses. The FDA’s Director of Biologics, Peter Marks, explained in a letter to the NY Times that

“any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.”

Sorry, Dr. Marks, but these excuses are nonsense. The Covid-19 vaccines have been rolled out with unprecedented speed, it’s true, but we’re now seeing the results of a real-time, real-world experiment on hundreds of millions of people, and–luckily–the results are great! Have you and your colleagues at the FDA not noticed this?

Furthermore, everyone knows that the vaccines will be fully approved in the next few months, and multiple government officials, including the President, have said so quite openly. So why not approve them today? Because you have to follow a set of bureaucratic rules that were not designed for a pandemic?

The virus doesn’t care about the rules. Infections in the U.S. are skyrocketing again, because of the Delta variant, and the only way to end this pandemic is to get nearly everyone vaccinated. Until we have full approval of the vaccines, we’re simply not going to get there. By relying exclusively on the paperwork provided by the vaccine manufacturers, and ignoring the enormous amount of real-world data that everyone can see, the FDA is prioritizing process over results.

The FDA says that it’s now in a “sprint” to approve the vaccines, but with every day that passes, more people get sick, and the virus has more time to mutate and become more deadly.

Listen, FDA: rules are created for a reason. In case you haven’t noticed, the pandemic is a worldwide emergency that cries out for you to bend or break the rules if doing so will save lives. We all want a safe and effective vaccine, but there’s an overwhelming amount of evidence that we already have at least 3 of them (and probably 6 or 7). You can approve the Pfizer-BioNTech and Moderna vaccines today, and if new data emerges, or if you discover something startling and unexpected in those millions of pages of paperwork, you can withdraw approval. There’s nothing preventing this except bureaucracy.

So don’t tell us that you (FDA) have to “complet[e] the high-quality review” or you’ll somehow be shirking your responsibility. That response is equivalent to saying “we can’t look at the overwhelming evidence from the real world, we can only look at the paperwork that the vaccine companies provided to us.” In other words, “nanner nanner we can’t hear you” rather than considering the fact that hundreds of millions of people have taken the vaccine and that it’s working.

And about that comment from the FDA about maintaining public trust? As Dr. Eric Topol pointed out in a recent op-ed, somehow the FDA managed to approve, in the midst of the pandemic, an incredibly expensive new Alzheimer’s drug (aducanumab) for which the evidence of effectiveness is very thin, and the risks of harm are very real. The FDA’s own advisors resigned in protest, and now the FDA’s inspector general is going to take another look at how this happened. And yet the FDA is worried about “public trust in the agency”? Give me a break. Meanwhile, the FDA can’t seem to find the time to approve the mRNA vaccines “despite massive evidence of their benefits.”

The FDA needs to stop hiding behind the mountain of paperwork. Millions of people will remain unvaccinated while the FDA reviews documents that merely tell us what we already know: the vaccines work, and they are safe. Give them full approval, today, and continue to monitor their safety carefully, and many lives will be saved.

Can You Improve Your Memory With A Jellyfish Protein?

Some colleagues of mine recently asked me about Prevagen, a supplement that is being advertised heavily on television as a memory booster. It's everywhere, they said–but what is it? And does it work?

Both questions are pretty easy to answer. On the first question, the TL;DR version is that Prevagen's primary ingredient is a protein called apoaequorin, which is found in a species of jellyfish that glows in the dark. These jellies produce two proteins, apoaequorin and green fluorescent protein (GFP), that help them fluoresce. It’s an amazing biological system, and the three scientists who discovered and developed the chemistry of GFP were awarded the 2008 Nobel Prize in chemistry.

Cool science! But what does this have to do with human memory? Not much, it turns out.

First let's examine what Prevagen's manufacturers, Quincy Bioscience, say about it. Their website claims that:

"Prevagen Improves Memory* 

Prevagen is a dietary supplement that has been clinically shown to help with mild memory loss associated with aging.* Prevagen is formulated with apoaequorin, which is safe and uniquely supports brain function.*"

Sounds pretty clear, right? But note the asterisks by each of these claims: if you scroll all the way down (or read the small print on their packages), you'll find out that:

"*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."

You may recognize this language: it's what all supplement manufacturers use to avoid getting in trouble with the FDA. It means, essentially, that the government hasn't approved Prevagen to treat anything, including memory loss.

Despite Quincy’s claims, I see no reason why eating this protein would have any effect at all on brain function. First of all, it’s not even a human protein, so it's unlikely to work in humans. Second, even if it did work in humans, eating it would not deliver it to our brains, because it would be almost certainly be broken down in the stomach. And third, the connection between any protein and memory is very complex, so simply having more of a protein is very, very unlikely to improve memory.

Quincy's website points to a single study that they themselves conducted, which they argue showed benefits for people with mild memory impairment. However, others have pointed out that the experiment (which was never published in a scientific journal) didn't show any such thing: overall there was no difference between people who took Prevagen and those who took a placebo, but the manufacturer's did some p-hacking to extract a subgroup that appeared to get a benefit. As Dr. Harriett Hall and others have pointed out, this kind of p-hacking is bogus.

And what about my observation that the jellyfish protein will simply be digested in the stomach, and never make it to the brain? It turns out that the company itself admits that I'm right. On their website, they have a "research" page pointing to several safety studies, designed to show that Prevagen won't cause an immune reaction. One of these studies explains that

"Apoaequorin is easily digested by pepsin."

Pepsin is the chief digestive enzyme in your stomach. So Prevagen's main ingredient never gets beyond the stomach, which is why it's probably quite safe. (Joe Schwarcz at McGill University recently made the same point.)

Back in 2015, I asked Ted Dawson, the Abramson Professor of Neurodegenerative Diseases at Johns Hopkins School of Medicine, what he thought of Prevagen’s claims.

“It is hard to evaluate Prevagen as to the best of my knowledge there is no peer-reviewed publication on its use in memory and cognition,” said Dawson. “The study cited on the company’s web site is a small short study, raising concerns about the validity of the claims.”

Finally, a word to those who are still tempted to try Prevagen: it isn't cheap. Their website charges $75 for a bottle of 60 pills, each containing 10 mg of apoaequorin, or $90 for 30 pills of the "Professional formula," which contain 40 mg. (Note that there's no evidence that taking a higher dose will work any better.)

The FTC sued Quincy Bioscience in 2017 for deceptive advertising, arguing that claims that Prevagen boosts memory are false, and that claims it can get into the brain are also false. Just a few months ago, a judge ruled that the case can proceed. Meanwhile, though, the advertising and sales of Prevagen continue. The FTC case states that Quincy sold $165 million worth of Prevagen in the U.S. from 2007 to 2015.

So the bottom line is: jellyfish proteins are very cool, but eating them won't improve your memory. If you're interested in brain food, perhaps you just eat more fish, which might actually work.

(Note: I wrote about Prevagen in 2015, and some elements of this article are based on my earlier one.)

Better diagnosis of infections

This week I'm not posting an article here because I wrote a piece for BloombergView, the online magazine published by Bloomberg, the company founded by Michael Bloomberg. The article is titled "Make Way for Better Germ Tests." Check it out here.

Government regulation to the rescue: FDA halts the overuse of antibacterial soaps

Over the past two decades, anti-bacterial soaps have proliferated. It got to the point, a couple of years ago, where it was difficult to find any hand-washing products in some stores that were not labeled "antibacterial." All the way back in 2001, a study by Eli Perencevich and colleagues found that 76% of liquid soaps on the market contained some kind of antibacterial agent. It only got worse after that.

The primary active ingredients in most of these soaps are triclosan and triclocarban, chemical agents that do indeed kill bacteria. However, as Perencevich pointed out,

"No scientific data have been published to suggest that the use of antibacterial agents in household products prevents infection."

It didn't take long for triclosan to start showing up in freshwater streams and elsewhere in the environment. Triclosan has been detected in the water supply in the U.S., multiple countries in Europe, Canada, Australia, Japan, and Hong Kong. As use of antibacterial soaps proliferated, bacteria resistant to triclosan started to appear–an outcome that any biologist could have predicted, and that many did.

After many years, the FDA finally announced, in December 2013, that manufacturers needed to produce actual data showing that their products worked. They didn't, for the simple reason that antibacterial soaps don't work any better than plain old soap and water.

Finally, this past Friday, the FDA stepped in. They are banning 19 different chemicals, including triclosan. Their announcement states:

"Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections."

This has been a very long time coming.

Antibacterial soaps are no more effective than simple hand-washing with regular soap, as Forbes contributor David DiSalvo explained last year. But people have been buying these products anyway, often not realizing that they might be hurting themselves and the environment. As Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, explained in the FDA announcement:

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water. In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

Sometimes government regulation is the only effective way to fix a public health problem. Kudos to the FDA for stepping in to protect all of us from potentially deadly outbreaks of antibiotic resistant bacteria. Let's hope that other countries follow the U.S. example.