[-] wjs018@beehaw.org 24 points 1 year ago

The type of pill that was approved is the progestin-only "mini pill" which has a much safer clinical profile than the more common-in-the-US combination pill that has both progestin and estrogen. This type of pill is already available OTC in over 100 other countries. The US is just really behind the curve on just about anything to do with reproductive rights and care.

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submitted 1 year ago by wjs018@beehaw.org to c/science@beehaw.org

cross-posted from: https://mander.xyz/post/1133527

Paywall-free link: http://archive.today/oPjro

[-] wjs018@beehaw.org 2 points 1 year ago

So far this season...

Enjoying:

  • Horimiya
  • Zom 100

Waiting to see how it plays out:

  • Vending machine
  • Ryza
  • One Room Hero
  • Helck

Waiting to binge after the season is over:

  • Kenshin

Old show I am currently watching:

  • Science Fell in Love
[-] wjs018@beehaw.org 1 points 1 year ago

I don't blame you for dropping Ryza. I am going to give it one more episode before dropping since I have heard good things about the source from a friend that is excited about it, but so far I have found it very dull.

[-] wjs018@beehaw.org 2 points 1 year ago

Username checks out!

1
submitted 1 year ago by wjs018@beehaw.org to c/medicine@mander.xyz

The issue seems to be how the data was collected in the Phase 3 trial:

Clinical trials of most drugs and vaccines supporting FDA approval are mainly conducted in the U.S. and Europe, where clinical trial protocols are well recognized. The phase 3 TIDES trial used for Qdenga’s application was run in several less well-off, dengue-endemic regions in Latin America and Southeast Asia.

However, it should be noted that Takeda's drug, Qdenga, is already approved by the EMA in the EU and a couple other agencies. It is just the FDA that is holding things up in the US.

[-] wjs018@beehaw.org 1 points 1 year ago

Please, please let Ooyama's accidental confession mean something. Imo, this series has really pushed the "do they like me" bit to the breaking point. If Akutsu goes back to questioning it, then it's clear this series is never going to see real relationship progress.

[-] wjs018@beehaw.org 5 points 1 year ago

The fine is from an unrelated, earlier incident in Alabama. From what I found on jalopnik:

Earlier this year, a worker was killed by being sucked into an airplane engine in Alabama on New Year’s Eve. The employee in that scenario was warned several times that the plane’s engines would be on, however. Still, OSHA hit the small airline Piedmont with a fine of $15,625 in the workers death.

This incident with Delta that happened in Texas is under investigation.

[-] wjs018@beehaw.org 3 points 1 year ago

That's fair. I couldn't find much info on their website, so I assumed this was another make insulin cheap using "biohacking" deal. I don't have any experience with small molecule synthesis or dry powder manufacturing, so I can't really speak to how feasible this may be. However, having seen first-hand all the ways simple manufacturing steps can go wrong, the risk of consuming a medication that hasn't been through rigorous QA/QC makes me very wary.

[-] wjs018@beehaw.org 21 points 1 year ago

Apologies for the long post. I don't mean this as an attack on OP, just trying to illustrate why actually doing this is a bad idea.

I have seen efforts like this in the past, especially centered around efforts to manufacture insulin cheaply. While I get that medicine cost and availability is broken at a fundamental level in the US, the solution is a political one rather than to run a wildcat bioreactor. There is simply no way to safely manufacture biologics using a 3d printed bioreactor. Let's look at the manufacturing process to get an idea of why.

Staring with the bioreactor, you would need some way to sterilize it before use (not just sanitize, there's a difference). There are plastic bioreactors that are used in industry, but they are large, single-use bags that are sterilized using gamma or x-ray radiation. Most industry bioreactors are made of stainless steel to withstand the harsh treatment required to re-sterilize them (steam or hydrogen peroxide).

Moving down the chain from the bioreactor, you need some way to remove your product from the harvested liquid. This is usually done through lysing the cells you have grown and then running this lysate through a series of chromatography columns of varying types (affinity, ionic, etc.) to systematically remove all the junk left over from your cellular media and the cells you have lysed. Even if you could (unsafely) grow your cells and drug in a 3d printed bioreactor, you don't have these kinds of things at home and can't just get them from Amazon.

However, let's say that you could get past the purification step, what's next? You find yourself with a large volume of very dilute medicine suspended in a chromatography buffer. The next step is what is called UF/DF, or ultra-filtration/dia-filtration. This step, paradoxically done DF first, uses filter membranes and large amounts of buffer and some pressure to first swap out the buffer that your medicine is in to the target formulation that you want to inject and then concentrate it down to a manageable volume. If you are working at small scale, then you can probably replace this step with just one filter and a centrifuge. Remember that while you are doing all this, everything that comes into contact with your drug needs to be sterile (even the air).

I think I have made my point, but for actual drugs there are more steps beyond this. Post-UF/DF is what is referred to as drug substance (DS) in the industry. You still need to go through a sterile fill-finish process to get drug product (DP) that is what is actually given to a patient. If you really want, I can go on another long tirade here since this is the step my job focuses on.

I have worked on these manufacturing processes and seen them fail a lot for very hard to catch problems. Without all the in-process controls and testing we do, there would have been serious risks of giving bad DP to patients. If you have read this far, then I hope I've convinced you not to give this kind of thing a try.

The real problem this is trying to solve is a political one. We should be advocating for better access to medications and reforming how costs are dealt with. It doesn't matter what your political persuasion is, I think everyone agrees healthcare in the US is broken and it's time something is done about it.

[-] wjs018@beehaw.org 3 points 1 year ago

I am glad I don't work in the clinical trial design space. It is already complicated enough to design a good clinical trial and this adds a whole other layer of complexity to it.

A sad component to this is that women are already underrepresented in clinical trials and this is likely to exacerbate the problem.

[-] wjs018@beehaw.org 4 points 1 year ago

It hopefully should. One of the main reasons biologics are so expensive isn't just corporate greed (though it is that too), but because the manufacturing process is very intense. Running bioreactors at commercial scale to make your product, using a train of chromatography steps to purify it, and then filtering it to be concentrated and sterile before fill/finish in a pre-filled syringe or vial followed sometimes by lyophilization is an insanely complicated process that is very costly. mRNA processes simplify this a lot in that the mRNA don't need to be manufactured using bioreactors that are filled with dirty cellular flotsam and jetsam that need removed. So, the production and purification parts are much much simpler. It still isn't likely to be cheap, as GMP manufacturing is still complex and the fill/finish part of the operations are largely unchanged, but hopefully cheaper.

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submitted 1 year ago by wjs018@beehaw.org to c/science@beehaw.org

cross-posted from: https://beehaw.org/post/720520

This summarizes a report from Parks Canada about the reintroduction of bison to the Banff National Park.

A Parks Canada report published this week concluded that the reintroduction was a success, and it suggested that due to their robust growth rate, this bison subpopulation—one of only five that occupy a mere 0.5 percent of their original range in North America—may no longer be considered endangered within a decade.

Original report: https://parks.canada.ca/pn-np/ab/banff/info/gestion-management/bison/rapport-mai-reintroduction-may-report

1

This summarizes a report from Parks Canada about the reintroduction of bison to the Banff National Park.

A Parks Canada report published this week concluded that the reintroduction was a success, and it suggested that due to their robust growth rate, this bison subpopulation—one of only five that occupy a mere 0.5 percent of their original range in North America—may no longer be considered endangered within a decade.

Original report: https://parks.canada.ca/pn-np/ab/banff/info/gestion-management/bison/rapport-mai-reintroduction-may-report

[-] wjs018@beehaw.org 4 points 1 year ago

I work in this field and this is a great summary of mRNA and its therapeutic usage. The article does mention it, but mRNA is going to be widely used beyond vaccines as well.

As an example, at a previous company I worked at that had a robust pipeline and a portfolio of antibodies on the market, they were actively developing an mRNA-LNP version of all of their mAb programs. The idea is that if you develop an LNP platform that can reproducibly transfect say, the liver, then you can just turn the liver into a protein factory for anything you provide the mRNA sequence for. Having mAbs produced and excreted in the body solves one of the big challenges to convenient biologics dosing, bioavailability. Basically, a lot of antibodies, when injected under the skin, have trouble making it from the injection site to your bloodstream. This can be solved by administering via IV, but that has many downsides when it comes to patient convenience.

The reason vaccines are the first successful application of this technology is because they only require very small doses to be effective. Compare the amount of protein that is in a flu shot (60 micrograms in Fluzone at most) to a typical mAb (~150 mg up to 1 g at most), you can see how much less the vaccine requires. I fully expect that as the upstream and downstream processes for LNP manufacture improve and are able to scale, that we will see mRNA take over what is currently the realm of biologics.

3
submitted 1 year ago by wjs018@beehaw.org to c/science@beehaw.org

This article summarizes some of the challenges as well as opportunities that Ukraine is faced with in a post-Russian invasion world.

In addition to the brain-drain effect of talented scientists leaving the country, Ukraine has some structural issues as well:

The current research system is composed largely of the Soviet-style national science academy — for which the research agenda was historically set by state officials — and a university sector in which research is funded by the science ministry.

Entirely lacking is a modern, performance-based grant-giving system...the centrepiece of a new system would include funding streams for basic research, competitive grants and defence-related projects. Ukraine’s research strengths include agricultural technology, energy and planetary science

doi: https://doi.org/10.1038/d41586-023-02031-8

4
submitted 1 year ago by wjs018@beehaw.org to c/science@beehaw.org

cross-posted from: https://beehaw.org/post/698268

This paper details a new hydrogel patch coated in microneedles used to delivery medication to tissues. The design of the patch was inspired by the Blue-ringed octopus and the method by which it administers toxins.

Unrelated to this paper (which is really cool) I feel like scientific figures have really fallen prey to a trend to cram too much information into each figure, making them impossible to comprehend. This paper as an example features two figures that go all the way from A through L. If you have to use almost half the alphabet to label your figures, maybe something can go to supplemental information.

doi: https://doi.org/10.1126/sciadv.adh2213

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submitted 1 year ago by wjs018@beehaw.org to c/space@beehaw.org

This article summarizes findings showing that the Spitzer telescope has observed the spectral signature of tryptophan in an extrasolar system.

This isn't the first instance of amino acids found extra-terrestrially (previously found on asteroids), but is the first found outside our solar system. Tryptophan has a very strong and very clear spectral signature (it is ubiquitously used in life sciences for example).

doi: https://dx.doi.org/10.1093/mnras/stad1535

[-] wjs018@beehaw.org 1 points 1 year ago

Back in the olden days of reddit, mods didn't need to accept their position. So, it was a troll tactic to promote people to moderator of a controversial sub and then take a screenshot. I have no knowledge of spez's moderating history, but I imagine this is the most likely scenario.

1
submitted 1 year ago by wjs018@beehaw.org to c/space@beehaw.org

I have linked a non-paywall version, but if you can, I suggest checking out the Times version of the story as it goes into much more detail and has lots of great pictures.

Essentially, NASA knew that if there were microbes brought back from the Apollo missions that they had no effective way to contain them. However, to assuage the public, they maintained that their quarantine procedures were effective. This is essentially quarantine theater to aid public perception of the Apollo program.

doi: https://doi.org/10.1086/724888

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