16 ms·
FDA approves drug to treat smallpox
- chromatin 5y agoThis is actually quite disconcerting, in the backdrop of questions surrounding SARS-CoV-2.
- jliptzin 5y agoYea, this is terrifying
- deleted 5y ago[deleted]
- thowaway959125 5y agoThere was also an interesting 2019 event possibly involving Ebola but is still being kept under wraps for national security reasons. https://www.cbc.ca/news/canada/manitoba/chinese-researcher-escorted-from-infectious-disease-lab-amid-rcmp-investigation-1.5211567 https://www.cbc.ca/news/canada/manitoba/chinese-researcher-e...
- omegaworks 5y ago> Complications of smallpox included encephalitis (inflammation of the brain), corneal ulcerations (an open sore on the clear, front surface of the eye), and blindness. A tragic reminder of the horror inflicted on indigenous people by the colonies that would become the United States[1]. A bioweapon used to craft the narrative of the empty, pristine continent, bestowed by God for the fulfillment of Manifest Destiny[2]. 1. https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(14)64174-4/fulltext https://www.clinicalmicrobiologyandinfection.com/article/S11... 2. https://www.theatlantic.com/magazine/archive/2002/03/the-pristine-myth/303062/ https://www.theatlantic.com/magazine/archive/2002/03/the-pri...
- echelon 5y agoNone of us can really do anything about that history other than think and vote for the future. If you look back even further, many of our ancestors were cannibals. Much of history was a pretty horrific time. All over the world. I think (hope) that the world is getting better. I wonder what people will look back and think of us.
- kokanator 5y agoFrom your citation: > Bioterrorism had already started 14 centuries before Christ, when the Hittites sent infected rams to their enemies. The non-modern world was indeed a vary barbarous world. It is amazing how far we have come in such a short time. Continue to vote and push forward.
- redis_mlc 5y agoThe Russians poisoned wells in Afghanistan only a few decades ago. (They gave up on limited battles and moved on to genocide to depopulate areas.) Fighting the Taliban is really fighting the Islamic ideology, so just shooting armed combatants is pointless. https://www.indiatoday.in/magazine/international/story/19830731-us-accuses-soviet-union-of-using-chemical-and-biological-weapons-in-afghanistan-770879-2013-07-19 https://www.indiatoday.in/magazine/international/story/19830...
- causality0 5y agoOne doesn't have terribly much to do with the other. Smallpox was introduced to the Americas in 1520. The only recorded attempt to deliberately infect Native Americans with it was in 1763 by a British officer. By 1803 the US government was already running smallpox vaccination programs for the Native American tribes with which they had contact. Not that the later Manifest Destiny actions weren't horrific and devastating, but they had nothing to do with creating an idea of a clean continent using disease. 19th century Americans were more than happy to invade and seize land that was fully inhabited.
- maj0rhn 5y agoThe Brits of that era were equal-opportunity smallpox infectors. They captured some of George Washington's slaves, infected them with smallpox, and then released them on the battlefield at Yorktown, hoping to spread disease back to GW. They also brought smallpox into the American camp before the battle of Quebec, and there was an epidemic.
- Exmoor 5y ago> Although the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that the virus that causes smallpox, the variola virus, could be used as a bioweapon. As I understand it, the variola virus's genome is known and it is possible to recreate it in a lab.
- riffic 5y agothere's no need for that when samples of the virus itself are still retained by two laboratories: https://en.wikipedia.org/wiki/Smallpox_virus_retention_debate https://en.wikipedia.org/wiki/Smallpox_virus_retention_debat...
- bpodgursky 5y agoThere are a lot more people who will soon have access to genome fabrication technology (there are already companies that do this as a service) than can break into a BSL4+ laboratory and steal one of the few remaining smallpox samples.
- 14 5y agoWould smallpox survive in a microscope slide? I remember my late grandpa had a microscope slide labeled smallpox in his basement. He was an old time doctor and had all sorts of neat things down there after he died. I don’t remember what happened but think the slide is still sitting in a storage shed or something. Always been curious about the risk of having such a slide.
- bpodgursky 5y agoNot a (real) scientist, but I think unlikely. The concern I see from scientists are bodies buried in permafrost, but ice preserves in a way basements don't.
- LeifCarrotson 5y agoNo, if the slide was prepared for storage the sample would have been embedded in a preservative with the cover glass glued down around the perimeter. The sample would likely be mixed with a mixture of alcohol, glycerin, and acetic acid known as AGA to prevent decomposition, this would kill any bacteria or viruses in the sample. I have a microscope from my uncle, also a doctor, which came with a ton of slides he prepared. If you don't know someone who had to build that collection of their own specimens in med school, you can get all kinds of prepared slides commercially: https://www.amazon.com/dp/B0836SH17X https://www.amazon.com/dp/B0836SH17X > Human Cell Mucus Membrane Smear 72 Dense Connective Tissue Section 73 Ciliated Epithelium Section 74 Oesophagus T.S. 75 Stomach Section 76 Small Intestine Section 77 Lung sec 78 Liver Section 79 Kidney Section 80 Spleen Section 81 Pancreas Section 82 Urinary Bladder Section 83 Ureter C.S. 84 Ovary Section 85 Testis Section 86 Oviduct T.S. 87 Uterus Sec. 88 Tongue L.S. 89 Trachea C.S. 90 Epididymis sec. 91 Large vein sec. 92 Thymus Sec. 93 Human Blood Smear 94 Motor Nerve W.M. 95 Spinal Cord C.S. 96 Human Hair W.M. 97 Artery and Vein C.S. 98 Arteriole C.S. 99 Human Skin Sweat Gland Section 100 Skin of Human(show hair follicle) Sec.
- kokanator 5y ago> Tembexa received priority review, fast track This is the same rating the COVID vaccines received. Either we are reacting to a real threat or preparing for perceived threat. It is possible some variola virus variant is being produced in a lab. This would obviously pose a risk necessitating precautionary measures.
- maxerickson 5y agoThere's not really any way to do efficacy testing. (safety testing in uninfected people should yield some information of course)
- refurb 5y agoNo, that’s not the same review process. You can take your tinfoil hat off.
- comex 5y ago> > Tembexa received priority review, fast track > This is the same rating the COVID vaccines received. That's true, but dozens of not-quite-so-urgent drugs have received those ratings as well. Priority review: https://en.wikipedia.org/wiki/Priority_review#Uses_of_the_priority_review_program https://en.wikipedia.org/wiki/Priority_review#Uses_of_the_pr... Fast Track: https://www.fda.gov/drugs/nda-and-bla-approvals/fast-track-approvals https://www.fda.gov/drugs/nda-and-bla-approvals/fast-track-a...
- trimbo 5y agoThis risk has been acknowledged for a long time. Shortly after 9/11 and the anthrax attacks in 2001, the US began stockpiling enough smallpox vaccine for the whole country[1]. They claim to have kept that stockpile going[2] but they also said the same of the PPE stockpile... [1] - https://www.cidrap.umn.edu/news-perspective/2001/11/acambis-wins-new-contract-supply-155-million-doses-smallpox-vaccine https://www.cidrap.umn.edu/news-perspective/2001/11/acambis-... [2] - https://www.cdc.gov/smallpox/bioterrorism-response-planning/public-health/vaccination-strategies.html https://www.cdc.gov/smallpox/bioterrorism-response-planning/...
- mjevans 5y agoGotta rotate the supplies. This is why even though I've _reduced_ my use of bottled water, I keep an active supply of bottles on hand at a level sufficient for an emergency and consume through the stock to keep it fresh.
- fomine3 5y agoWhat for use?
- GoOnThenDoTell 5y agoWhen water stops coming out of the pipes
- dadro 5y agoCoincidentally I just finished reading Biohazard by Ken Alibeck and while old news (circa 1999) it left me with no doubt that there are still stockpiles of bioweapons grade smallpox in military labs. This news is strangely reassuring given how low vaccine stockpiles are against these awful diseases.
- mikesabbagh 5y agoHow can you test the effectiveness of this drug against smallpox?
- elihu 5y agoFrom the article: > Because smallpox is eradicated, the effectiveness of Tembexa was studied in animals infected with viruses that are closely related to the variola virus. Effectiveness was determined by measuring animals’ survival at the end of the studies. More animals treated with Tembexa survived compared to the animals treated with placebo. FDA approved Tembexa under the agency’s Animal Rule, which allows findings from adequate and well-controlled animal efficacy studies to serve as the basis of an approval when it is not feasible or ethical to conduct efficacy trials in humans. That's a little disconcerting that there are viruses that are similar, that they're severe enough to kill the host, and that they're willing to use it in tests. Perhaps these viruses they're using aren't nearly as contagious? Or they're not transmissible to humans?
- 5co 5y agoThere’s a variant of pox for most animals, they aren’t dangerous to us. There’s even 2 variants of kangeroopox. Not even joking.
- haimez 5y agoTIL factoid of the month, easily.
- ChrisRR 5y agoYour second little fact is that "factoid" means a lie that has been spread so widely that it's treated as a fact, and doesn't mean a little fact
- Ariarule 5y agoMeta-humor, maybe? "A factoid is either an invented or assumed statement presented as a fact, or a true but brief or trivial item of news or information" -- https://en.wikipedia.org/wiki/Factoid https://en.wikipedia.org/wiki/Factoid
- elliekelly 5y agoIf smallpox-as-a-bioweapon is even a slight possibility why don’t we start vaccinating for it again? It seems like it would be much easier to prevent the problem at all rather than to try to respond to it.
- nyokodo 5y ago> why don’t we start vaccinating for it again? Because vaccination isn’t 0% risk. Very few people are going to acquiesce to vaccination for a functionally extinct virus nor should they. Perhaps those who want to should be able to but that’s another discussion.
- deleted 5y ago[deleted]
- TylerE 5y agoBecause it no longer exists in the wild. All vaccines have some risk of negative reactions. No matter how small x is, x is > 0, which is the current chance of being infected by smallpox.
- kps 5y agoThe current smallpox vaccines stockpiled in the US use a live virus¹ and have a fairly high rate of serious side effects (1–2%) for a disease that doesn't currently exist. The vaccines are also still effective a few days after exposure to smallpox. ¹ https://en.wikipedia.org/wiki/Vaccinia https://en.wikipedia.org/wiki/Vaccinia
- ohazi 5y agoAlso, the way the smallpox vaccine is administered is mildly gruesome: > A droplet of ACAM2000 is administered by the percutaneous route (scarification) using 15 jabs of a bifurcated needle. ACAM2000 should not be injected by the intradermal, subcutaneous, intramuscular, or intravenous route. (emphasis mine) https://en.wikipedia.org/wiki/Smallpox_vaccine https://en.wikipedia.org/wiki/Smallpox_vaccine https://en.wikipedia.org/wiki/Bifurcated_needle https://en.wikipedia.org/wiki/Bifurcated_needle
- elzbardico 5y agoThis should be great news, probably is. But given the current context, it is downright Michael Crichton's creepy
- mchusma 5y agoI'm confused by the FDA. So last June, there were 3 COVID vaccines that passed phase I clinical trials and animal challenge studies. There was an active pandemic raging, and vaccines were almost certainly had 100x less risk for those over 65 (a statistical no brained) But somehow, they kept all vaccines banned for another 6 months killing hundreds of thousands. Nothing. But in the last week they approved an Alzheimer's drug that basically doesn't work (they have 9 years to prove it) and a smallpox drug with no human studies. Why couldn't we have unbanned the vaccines long before we did? Those that said we can't possibly approve something without following an exact process this week we're just totally proven wrong. I think the bar for "not banning" should be lower. The bar for "medicare must pay infinity dollars for it" should be higher.
- peter422 5y agoNot all the vaccines worked. You are taking for granted the knowledge we have now about the vaccine efficacy. If there were no efficacy studies we could easily have wasted precious manufacturing and logistical resources in an ineffective vaccine which would have cost even more lives. Not to mention increasing the vaccine hesitancy which is already a massive problem.
- jrowley 5y ago> FDA approved Tembexa under the agency’s Animal Rule, which allows findings from adequate and well-controlled animal efficacy studies to serve as the basis of an approval when it is not feasible or ethical to conduct efficacy trials in humans. How doesn’t this make sense?
- aaomidi 5y agoVaccines are usually tested for a much higher standard because It's generally taken by a LOT of people and to PREVENT something. It's a proactive medicine rather than reactive. FDA is a lot less strict with reactive medication, especially in cases where the disease is just fucking awful. This is also the technical reason why male birth control hasn't hit the market yet. They don't consider pregnancy to be an issue for men, but do for women. Hence they tolerate the side effects of BC for women a lot more.
- mews_ 5y agoOK but this is assuming it isn’t a highly modified virulent strain of smallpox. Which would be my main concern, because god knows what happened to Russia’s stockpile of weaponized smallpox after the fall of the USSR. It wouldn’t surprise me if some of that is still floating around somewhere in a freezer…
- thisisauserid 5y agoIt's weird how matter-of-fact people were about smallpox in some memoirs. Casanova's descriptions are revolting but everyone just went on with their lives. 14-day quarantines when traveling were annoying but common (though maybe those were for plague).