Category: Uncategorized

If you think the FDA has been slow at approving new coronavirus tests just look at their process for approving sunscreen products.

EWG: The FDA first began working to update sunscreen regulations more than 40 years ago. In February 2019, the agency at long last issued a proposed set of final rules, but they were never adopted.

According to EWG, the Environmental Working Group, the FDA has been too slow to test old ingredients for safety and too slow to allow new ingredients on the market thus leaving us with sunscreen products which are neither as safe nor as effective as they should be. In particular, Europe has better sunscreen protection than the United States. Here’s EWG:

Americans have fewer choices and notably poorer protection than Europeans do from ultraviolet A rays in their sunscreen options. Although most U.S. sunscreens prevent sunburn effectively when used correctly, they aren’t as good as European sunscreens at preventing the more subtle skin damage produced by lower-energy UVA radiation. UVA rays have less energy and don’t burn the skin, but they can cause the skin to age, suppress the immune system and contribute to the development of melanoma.

…Between 2003 and 2010, sunscreen makers applied for FDA permission to use eight sun-filtering chemicals developed by European companies. Four of these – Tinosorb S, Tinosorb M, Mexoryl SX and Mexoryl XL – appear to be more effective than avobenzone, the most common UVA filter permitted by the FDA. The FDA’s failure to respond to these applications prompted Congress to pass the Sunscreen Innovation Act of 2014 (FDA 2014). This act requires the FDA to review new applications for sunscreen active ingredients within 300 days, but it doesn’t relax the standards companies must meet to prove new ingredients are both safe and effective.

In 2015, the FDA responded that the companies involved had not submitted enough information to prove their chemicals were, in fact, safe and effective for use (FDA 2015). The agency asked for more data, including complete study results, measurements of ingredient levels in people’s blood, and long-term studies on systemic toxicity and potential endocrine system disruption. The FDA has also proposed that all sunscreen ingredients, including those already in use, need to have adequate safety testing data.

Some information the FDA wants, such as complete copies of studies, might be easy for sunscreen makers to produce. But in other cases, the companies could take years to satisfy FDA requests. In the meantime, Americans are being shortchanged.

I first wrote about this issue in 2013 and seven years later, despite Congress passing a law in 2014, the FDA still has not acted.

My rule is very simple. I don’t think the FDA is better than the EMA so if any drug or device is approved in Europe it ought to be available for purchase in the United States with a label saying “Approved by the EMA. Not approved by the FDA.” (By the way, we do have reciprocity type agreements with Canada and New Zealand for food so this would not be unprecedented.)

Hat tip: John Thacker.

Addendum: You should actually get more sun to avoid vitamin D deficiency which is bad for a variety of reasons including, in my estimation, greater susceptibility to COVID.

1. Interferon treatments probably work against Covid-19.  And NYT coverage.  But a better system of clinical trials is needed.

2. “Taking your dog for walks twice a day for at least an hour in total could soon become the law in Germany.”  And: “A spokeswoman for the agriculture ministry said it was very unlikely private dog owners would receive police visits to check whether they had taken their pooch for a walk.”  And: “The French have the unfortunate distinction of being the European “champions” for abandoning pets that have become too cumbersome for their summer trips.”

3. Heckman curve update update.

4. A thread on SalivaDirect.

5. Home field advantage seems to be gone in baseball, left with the crowds.

6. Best Korean films of the new century.

7. Gerald Gaus has passed away.

1. Transparent public toilets in Japan, they turn opaque when in use.

2. Guide to the coronavirus genome.  Lots of substance in this one.

3. What if the economy does not tank in August?

4. Researchers can duplicate keys from the sounds they make in locks (link fixed).

5. Netflix and complacency: “Netflix is testing a ‘Shuffle’ button, because you’re tired of picking what to watch.”  Or is it serendipity?

6. Detailed and very good WSJ article on how America fell behind on Covid testing.

Supply chains were hit hard early in the pandemic. Disinfectant couldn’t be produced because of a lack of bottles, tests couldn’t be processed because nasal swabs or PPE wasn’t available, the decline of passenger air traffic hit commercial delivery and so forth. I worry about forthcoming stresses on the vaccine supply chain. Billions of doses of vaccine will be demanded in the next year and a lot will depend on complicated supply lines including cold storage, air traffic, styrofoam, vials, bags, needles and many other inputs. Companies and the awesome team at CEPI (give them all a Nobel prize) are planning for vials and needles and other inputs but there are many non-obvious inputs higher up in the supply chain that also need shoring up.

Writing in Bloomberg, Scott Duke Kominers and I look at some of the odder inputs to vaccines like horseshoe crab blood, shark livers and the vaccinia capping enyzme, VCE. We are actually not too worried about horseshoe crab blood and shark livers as these are used in other industries. Shark livers, for example, are used to produce a lot of cosmetics so we should be able to divert supply as needed. VCE, however, is rarer.

DNA and mRNA vaccine technologies have shown promising results, and two of the leading vaccine contenders, from Pfizer Inc. and Moderna Inc., use mRNA technology. But mRNA has never been used to produce a commercial vaccine for humans, let alone at scale. And scaling these technologies may not be easy. In particular, mRNA degrades rapidly. To prevent this, it must be “capped” by a very rare substance called vaccinia capping enzyme.

Just over 10 pounds of this VCE is enough to produce a hundred million doses of an mRNA vaccine — but the current manufacturing processes for VCE require so much bioreactor capacity that making 10 pounds would cost about $1.4 billion. More important, global bioreactor capacity cannot support production at that level while also producing other vaccines and cancer-fighting drugs.

If we work hard now, we may be able to find more efficient means of producing VCE. Expanding bioreactor production and repurposing bioreactors from existing large-scale industrial applications will also help to lessen the pressure on the supply chains for multiple types of vaccines.

In addition to supply chains per se we also face the problem that companies are not raising prices enough. Ironically, this means that we need more public investment.

Of course, we might think that private companies would have incentives to coordinate supply chains themselves — and to some extent, they are doing so. But many have pledged to keep their vaccine prices close to costs, both out of altruism and because they may fear public backlash (or legal action) if they’re perceived as “price gouging” in the middle of a pandemic. And if companies don’t stand to profit much from Covid-19 vaccines, then they don’t have much incentive to invest in increasing capacity. In short: If prices can’t rise, then the only way to encourage companies to invest more in production is to reduce their costs — and that means we need public investment.

More generally, it’s not too late to be building more vaccine capacity and to repurpose bioreactor capacity from non-GMP sources, perhaps including veterinary and food sources. There are lots of vaccines in development. The science is promising. We need to take action now so that we can deliver on that promise.

Read the whole thing.

1. Relative to age, India’s Covid-19 fatality record is not so great.

2. Markets in everything: underground gyms.

3. Pandit Jasraj has passed away, here is some music.

4. Lacrosse play has to some extent continued (NYT).

5. How the Chinese CDC failed.

1. New podcast on (serious) natural philosophy.

2. Laos fact of the day.

3. “Her TikTok account as of August 2020 has over 78 million followers.”  Link here, can you name her?

4. Thread on the basics of herd immunity claims.  And the NYT covers herd immunity.  A very good piece in fact.  Semi-herd immunity says I, or “imperfect immunity” to use the terminology of the article.  And you will note the extreme epistemological conservatism emanating from the mainstream experts interviewed.  Appropriate in some ways, not in others.

5. Was Winky Dink the first interactive TV show?

6. “They promised us driverless cars, and all northern Virginia got was this 15 mph one-route public transit shuttle.”

7. WSJ review of new Bruno Macaes book on America.  The predictions of the book are holding up very well so far!