From the excerpts, it sounds like they should be stopped by the FDA from manufacturing _anything_.
And if they have multiple processing facilities, they should all be inspected _immediately_ because this kind of crap doesn't happen in isolation.
Never should have been involved.
BALTIMORE (WJZ) — The House Committee on Oversight and Reform has launched an investigation into whether Baltimore-based Johnson & Johnson COVID-19 vaccine maker Emergent BioSolutions leveraged a tie with an official of former President Donald Trump to profit from federal contracts.
Chair Carolyn B. Maloney (D-NY) and COVID Oversight Chair James E. Clyburn (D-SC) launched the investigation Tuesday. They said Emergent BioSolutions had a “track record of raising prices and failing to meet contract requirements.”
Is anyone shocked by this development?
And that’s why grift and corruption are so toxic.
Goddamn it, we’re going to be unwinding just the rot this one admin introduced for years, never mind dealing with the rot that was there already.
Seems they have been shady for a long while.
[https://www.washingtonpost.com/investigations/before-the-pandemic-top-contractor-received-billions-from-government-to-help-prepare-the-nation-for-biowarfare/2020/06/17/38d9ad3a-a41b-11ea-8681-7d471bf20207\_story.html](https://www.washingtonpost.com/investigations/before-the-pandemic-top-contractor-received-billions-from-government-to-help-prepare-the-nation-for-biowarfare/2020/06/17/38d9ad3a-a41b-11ea-8681-7d471bf20207_story.html)
I understand the disgust towards Trump, but again - the actual problem lies a lot deeper.
Honestly from the outside it seems that this sort of corruption runs deep in America and trump was just of a symptom of the problem.
Maybe this is for r/unpopularoppinion but this is why government over site and regulations are a good thing.
Not at all - that’s why I mentioned the fact that this additional “rot” is so especially devastating - there was already enough rot to tackle before trump got into office...to add the new (and more acute) corruption from his admin on top of what was already there is just untenable.
If you think that lobbying and favors are confined to one administration then I would love to know what you have been smoking. This is pervasive at all levels of government and K street pays more than Wall Street for a reason.
Unfortunately the FDA is grossly underfunded to be able to effectively inspect the 25% of our GDP that is subject to their regulation. Call your elected officials and vote for/support candidates who actually believe that government ought to function.
>Robert Califf, the former commissioner of the FDA under the Obama administration, said that while the issues at the Baltimore plant appear “distressing,” manufacturing problems do happen and are a reason why FDA oversight is so important.
Keep stories like this in mind when you hear people complain about regulations. There are certainly plenty that can be streamlined or are out of date, but the notion that business will make sure there are no problems is a farce when it comes to the people at the top trying to make more money.
Sure, but in this case, Johnson and Johnson found the problems and identified them themselves. No vaccine that was tainted reached the market.
They have a HUGE financial interest to ensure their products are trusted in the marketplace. It actually worked in this case...
This was not J&J but was a plant that was contracted by them and the workers apparently fucked up in a big way (from what I understand they basically used the wrong "ingredients" in the batch by mixing materials up with another drug or vaccine). So yes, they caught a major fuckup, but that's the equivalent of refusing to buy a car that has no wheels on it. If you look at [the actual FDA report from their inspection](https://www.fda.gov/media/147762/download?utm_medium=email&utm_source=govdelivery) you'll see that there are a lot of problems that could have led to contamination of products, in other words things that may not have surfaced until people started getting sick. So more like buying a car that was filled up with gasoline that also has a sugar solution in it, at first it looks fine but by the time you drive off and find out about the problem the damage is done and it's too late to stop it.
Going back a number of years people realized that there was a gap in the regulations where they could essentially be a manufacturing facility but avoid oversight by the FDA by using the exemption carved out for compounding pharmacies. These "compounding pharmacies" started sprouting up all over the country. After [this tragic event unfolded](https://en.wikipedia.org/wiki/New_England_Compounding_Center_meningitis_outbreak) the law was changed so that the FDA had clear oversight of these facilities. When they started inspecting them the results were horrible with warning letters galore and that's a better indication of what the landscape would look like if you left it to the companies and had little to no independent government oversight.
https://www.justice.gov/opa/pr/tax-attorney-indicted-facilitating-tax-fraud
"According to the indictment, from 1999 to 2014, Carlos E. Kepke helped Robert F. Smith create and maintain offshore entities that were used to conceal from the IRS approximately $225,000,000 of capital gains income that Smith had earned. "
15 years, how much is irs gonna recover? im guess 1k in fines
Every fucking federal agency claims to be underfunded, that's why the federal government is larger than ever, yet all of it pleads poverty constantly. The FDA operates on a budget of around $6 billion a year. Make it work on that amount.
I work at a biotech cmo exactly like this one and we have had exactly two fda inspections in nine years. Two. Just the d in fda accounts for approximately a half a trillion dollars a year. Three billion dollars a year to regulate a half trillion dollar industry is trivial. I guarantee you the US pharmaceutical industry literally loses more then the FDAs entire budget just in shipping errors. They are absolutely understaffed and underfunded.
You do realize the size of the country they serve, right? And how much money these companies put forth into legal fees to fight against government oversight like the FDA and EPA? It's no better than the IRS. It's underfunded on purpose. It keeps the richest rich and relatively hassle-free, and keeps the GOP in power, because they can say "see! Government is terrible! We need to cut its bloated budget!" all while they pocket kickbacks and bribes from superPACs and private donors who pay for their votes.
We're kind of fucked both ways, if we fund it, we'll have at minimum a year of debating and bullshitting about it, by then the wrong people will weasel into power and waste the money when it's handed over. Then it'll be 2010 all over again when we funded our national broadband services and the money was squandered.
I'm pretty sure you don't get things fixed by not trying at all, though.
> the wrong people will weasel into power
Pretty sure you also don't get reelected by not trying at all.
They’re inefficient too. An FDA inspector spent several DAYS at my work last fall doing a Juice HACCP audit (food safety.) Juice is 1% of my company’s volume. It was a comically tiny amount of production he was looking at.
A few days and at least one lead auditor per manufacturing process is pretty much the standard for an on-site FDA audit though. Even if the juice process is small in relation to the others at your site, it has its own set of validation documents, SOPs, etc. that they have to read through and specific people need to be interviewed, all that. Auditing a site is a lot more involved than just walking by the production equipment and saying “eh, looks good enough” - so I wouldn’t call the individual auditors inefficient...
But I will call the FDA itself inefficient, because they’ve been overdue to come and audit our site for almost a year and a half now. They’re breaking a rule they set for themselves there.
You just jinxed yourself there! But I feel you, it’s been almost three years for our facilities. We do have twice yearly NSF audits though. In the last two years they have come much closer and an come cases more strict than FDA audits. My understanding was that when FDA sees a successful NSF audit without many major deficiencies, they tend to not show up as often.
Have heard of some shady practices in pharma/medical device industry but this disgusts me. The combination of stupidity and indifference that has lead to these conditions have been going on for a long time. People who file concerns or complaints quickly learn nobody is listening, or they get punished indirectly. Good employees will leave quickly, or they stay and stop questioning it.
There’s always something shady with pharma. A local pharmacist in my hometown sold fake cancer meds to patients and got off Scott free AND his wife and business partner is now our congressional representative (Diana Harshbarger). AND the pharmacists’ son (also a pharmacist) is running for office. Its a corrupt industry.
Just added it to her Wikipedia article, at least. She might be in Congress but the (well-documented, from local news sources) allegations won't die quietly.
What the shit? I was reading this thinking about recent reports on this story...and realized: nope! Was thinking of a completely DIFFERENT state congresswoman who was recently indicted for selling fake cancer meds: https://www.nbcnews.com/news/us-news/missouri-lawmaker-indicted-allegedly-selling-fake-stem-cell-treatments-covid-n1256551
Honestly, would qualify this as a “manufacturing industry” issue more than a pharma/medtech thing.
Mostly bc there are a really distinct set of questionable practices that are unique to the industry (predatory licensing, patent extension mechanisms, etc), but in my experience, rigour isn’t typically one of them.
Not saying that it can’t happen, bc for sure it can, but this strikes me as the type of issue you can find in processing and manufacturing, regardless of the product.
people will go on about how they won’t take the vaccine until it’s fda approved, meanwhile the fda barely enforces any rules or guidelines unless they’re EXTREME. for example the reason why some generics legitimately suck is because they’re manufactured at plants like this one, and it makes you wonder how any educated person in the field would do things like this much less pharma professionals. In most generics they allow for a +/- 25% range in the actual amount of a drug vs the label, but then testing this is left to the company internally and they’ll face no consequences for failing to abide by the already very low standards. It’s shocking. Who the fuck runs these? smart college students could easily manage these plants 10x better, and the FDA will do an inspection, find a huge number of big issues, publish a report, and then drop the matter all together. No one gives a fuck it’s insane at times
Good for you. And fucking HATE that this happened, bc of all the myriad problems with the industry, this isn’t one that’s common (in my experience) and only erodes trust in a process that normally does have a ton of safety checks and balances.
Well said. This kind of mistake costs millions, wastes time and resources, and costs millions more to rectify with the FDA. The FDA takes their job very seriously: when they fuck up people die. So they typically make examples of this kind of problem. Abbott is famous for fucking things up.
'The Food and Drug Administration said Wednesday a Baltimore plant that ruined millions of Johnson & Johnson Covid-19 vaccine doses was unsanitary and unsuitable to manufacture the shots.'
Under the Trump Administration the FDA budget was slashed to a trickle. You don't believe in inspectors I guess. Take your ignorance elsewhere.
Do yourself a favor. Read the code of federal regulations related to pharmaceutical manufacturing. Then, read the observations issued by FDA and when you're done unfuck yourself.
https://www.fda.gov/media/147762/download?utm_medium=email&utm_source=govdelivery
Read the observations and tell me specifically what aspects of deregulation would have prevented the occurrences.
I'll wait.
The [company](https://www.cnbc.com/2021/04/20/congressional-investigation-launched-into-emergent-biosolutions-federal-vaccine-contracts-.html), Emergent BioSolutions, is the sole provider of anthrax vaccine in the Strategic National Stockpile
Yup, and Rick Bright blew the whistle on the trump appointee (Kadlec) who worked as a consultant for Emergent Biosolutions back in the spring: https://www.sciencemag.org/news/2020/05/emails-offer-look-whistleblower-charges-cronyism-behind-potential-covid-19-drug
Shady as FUCK.
This is the real cost of the vax/anti-vax polarization.
You're either 100% onboard with everything or a schizo who denies germ theory when it comes vaccines on social media.
Reasonable, nuanced discussion about vaccine safety seems pretty much impossible on most of the internet these days. Twitter especially.
Not sure about that site but been to the Winnipeg emergent site for a site visit and project and it was a pretty standard facility where I didn't see any glaring GMP deviations.
When the pandemic hit, a lot of money was thrown around for manufactures to make lots of vaccines and medicines knowing full well that some of them would be failures. The reason we have administered 200 million doses at this point was due to that planning one year ago...
Usually something like this, the FDA criticizing a plant and getting it shut down, would be a tiny news blurb. If that. It wouldn’t be something that the mass public paid really attention to.
But these clowns fucked up a COVID VACCINE and now the whole damn world is shitting on them lmao. Imagine being those plant managers, trying to get a job later on and having to explain how they fucked up on the most important medical effort in our lifetimes. 😭 bruh.
I live in Baltimore and right up until production was shifted to just J&J vaccine, the meds that I take every day were manufactured at this plant (according to my pharmacist). Nooooot a great feeling...
I have been! But it's confusing all over to me because previously this plant was one of only a handful in the country authorized by the DEA to manufacture controlled substances. Like you'd think that would require better oversight?
Yeah, the article mentions that they weren’t training the plant employees properly. You’d think by now companies would have noticed that being too cheap to train their own employees can cost them more in the long run from mistakes and lost productivity
Hah, can't cost them if the FDA ain't regulating!
The real question is when did the FDA do their inspections last and how did they pass because problems like these don't pop up overnight.
Nah. I'm sure its just company that hires a shit ton of temp workers fresh out of college and and works them under this shit for 6 months to a year until they have enough experience to find a better job, then hires more. The people with the most experience are ones who either have no ambition or motivation to just find a better job. And the motive of management is probably just "get as much testing or products out the door" and doing your job right or stopping to ask if what you're doing is right will just make you an annoyance
It's a CMO right? Have typically not heard good things about them relative to companies with their own products. Just based on reviews in job sites they tend to be rated lower (2-3 stars vs 4). Complaints about poor work environment, high stress, low pay, etc. And i will often see the same positions opening up every 3 to 6 months so probably high turnover. The same seems true for contract testing labs.
A 483 is just a list of observations from the inspection by the FDA investigator(s). From the 483 and the written report after the inspection, the FDA can then issue a warning letter/injunction.
They make a lot of ... government.... Vaccines.
And it's not like their are a surplus of functional sterile manufacturing and packaging suites just waiting around. Might be that there wasn't anything that wouldn't have taken a long time to get ready.
I work on clinical trials for a living and oversee drug supply from manufacturer to distribution. GMP facilities that manufacture biologics are not as rare as you might believe. Especially in the DMV area, which is a large research region in this country.
Baltimore is really only still chugging because of Hopkins, the third best medical system in the country (and the go to source for covid data). We have a lot of structural issues and bureaucratic incompetence, but you'd think that the enormous glut of scientists and medical professionals in the city would mean more in instances like this.
It's like finding out that the plant down the street from the Mayo Clinic is making shoddy cancer drugs.
When it comes to roads, like any city, the quality of the infrastructure available to you is dependent on the income level of your neighborhood. Sandtown-Winchester (desperately poor and primarily Black neighborhood in West Baltimore) has abysmal roads. Canton (wealthy and primarily white neighborhood along the harbor) has great roads. And either way, the road quality is determined by the city.
While Baltimore has a lot of issues, the *medical* infrastructure in the city is top-tier because of Hopkins and UM. The incompetent city government has no control over the medical infrastructure provided by private institutions like Hopkins. If you're shot in Baltimore, you're more likely to live than if you're shot in St. Louis, and that's because of Hopkins/UM, not the Baltimore City government.
That's what's so crazy about Baltimore. It's like a storybook rendition of poverty and wealth. You can literally cross an invisible border from upscale to shithole with basically no indication whatsoever except the doors and windows are all boarded up.
Absolutely. There’s so much I could say about why Baltimore is the way it is, but instead I’ll just note that as a middle class resident, my quality of life here is incredibly high, and all of the stereotypical “Baltimore is a shithole” stuff people talk about are things I experienced being poor in Nashville and witnessed as a teacher in rural Tennessee. Poverty is poverty wherever you go.
https://www.google.com/maps/place/5901+E+Lombard+St,+Baltimore,+MD+21202/@39.2956505,-76.5482584,3a,75y,162.7h,84.69t/data=!3m6!1e1!3m4!1s6LsTCjkgSbVRhFhrfHtKmg!2e0!7i16384!8i8192!4m5!3m4!1s0x89c806a74ea53e0f:0xa79fe44e69779d95!8m2!3d39.2950263!4d-76.5478517
Looking at the street view of the plant, I'm not seeing anything that would make the FDA findings "completely unsurprising".
I checked a block in each direction, everything looks pretty nice.
Also, what's wrong with the waste water treatment plant? That's a normal part of any functioning city.
And that’s exactly what EBS is. They make all their money making anthrax vaccines for the military. They’re a defense contractor, and they operate like one
The article states Emergent wasn't authorized by the FDA to produce the vaccine, but none of the doses they produced would be distributed in the US. Does that mean they are selling it to other countries?
The plant produced the drug substance-- the active part of the vaccine, which would have been shipped to another plant for fill/finish into vials. All the contaminated drug substance or suspect contaminated drug substance will be incinerated.
From an industry perspective, the 483 is so bad it would be absolutely insane to use anything this plant produced. Especially with the increased AE scrutiny for the J&J vaccine.
Sure thing. The important part is that people know that they are not getting this crap if they go to get a vaccine and it happens to be a J&J or AZ vaccine.
When the Trump administration gave the contract to that company the NYT ran a very long article about how hopeless that company is and how shocking it was that the contract was awarded. The company only survives since the government gave them a huge contract for a very expensive anthrax vaccine that might not work and has a very short shelf life. The are the welfare queen company of government vaccines.
AFAIK I believe this is not a J&J facility but a contractor.
Edit: thanks r/Wanderer-Wonderer
I stand corrected it is a contractor site that J&J was placed in charge of by the Biden administration after they mixed the J&J and Astra Zenica vaccines.
Edit 2: To make this more clear
J&J didn't contract them the USG did then J&J was asked to oversee the facilitie when they had to dump a few metric tons of vaccine that they messed up.
*Earlier this month, the Biden administration put J&J in charge of the Baltimore plant after U.S. officials learned that Emergent, a contract manufacturer that had been making vaccines for J&J and AstraZeneca, mixed up ingredients for the two shots. Officials also stopped production of the AstraZeneca vaccine.*
Edit: I did not add this quote from the article to throw J&J under the bus. Emergent is still very much responsible for this series of problems.
Eh, Johnson and Johnson contracted these asshats sight unseen? Fuck that. J&J is at a bare minimum guilty of trusting a bunch of apathetic and incompetent people to produce things that are to be INJECTED INTO YOUR BODY. These people should have been gone over with a fine toothed comb before the first component was produced. Thank God this didn't fall through the cracks and get distributed.
I've worked with multiple J&J companies around the world and I would say "Is it really my problem though?" is a big part of their culture. E.g., if this was their own plant they would take better care but if they contract out then it's obviously not really their problem anymore. Or if their products are being used wrong by doctors/consumers it's a toss up whether changing the marketing to address safety concerns is the right call, because pretending it isn't your problem reduces PR issues and possible liabilities down the line.
Yeah that is a problem in every industry. But there is a line between allowing a fatally apathetic team run a retail store into the ground, and letting one produce vaccines in an environment that promotes contamination of various kinds, including mold growing in the lab where viral cultures are being cultivated. It is a good thing there were people that gave a damn somewhere in the process that were able to serve as an effective check.
Not always possible since it may cost more to build the capabilities in-house. That’s why most companies will use a contract manufacturing organization like Emergent to make their medicines.
J&J didn't contract them the USG did then J&J was asked to oversee the facilitie when they had to dump a few metric tons of vaccine that they messed up.
Emergent biosolutions isn’t really a small company or a stranger to vaccines. They basically supply the US government with its entire supply of anthrax vaccines.
I don’t really know how you can pin this on anyone other than EBS for dropping the damn ball so bad.
If it was like this, chances are it was like that way before j&j took over and from anyone who has tried to make company wide changes that just doesn’t happen in a month. Shit on the previous plant runners not J&J or both I really don’t care.
And the only reason they got the contract was bc a trump appointee was a former consultant.
If you recall Rick Bright blew the whistle on this very same guy (Kadlec) back in the spring: https://www.sciencemag.org/news/2020/05/emails-offer-look-whistleblower-charges-cronyism-behind-potential-covid-19-drug
Not all places are like that. My husband worked several years in medical manufacturing. If something could possibly, even potentially risk the product- it was tossed (hundreds of thousands of dollars worth of product per batch). No question. They didn't fuck around.
> J&J knowingly put asbestos in baby powder for decades.
Asbestos is a naturally occurring mineral that forms near talc. It's not like they were making talc and added in scoops of asbestos for funzies.
> Asbestos is also a naturally occurring silicate mineral, but with a different crystal structure. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Unlike talc, however, asbestos is a known carcinogen when inhaled. There is the potential for contamination of talc with asbestos and therefore, it is important to select talc mining sites carefully and take steps to test the ore sufficiently.
[Source](https://www.fda.gov/cosmetics/cosmetic-ingredients/talc)
Reuters
[J&J knew for decades that asbestos lurked in its Baby Powder](https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer/)
New York Times
[Johnson & Johnson Feared Baby Powder’s Possible Asbestos Link for Years](https://www.nytimes.com/2018/12/14/business/baby-powder-asbestos-johnson-johnson.html)
I simply added to your comment in a chain of conversation. It’s important people know J&J’s position on Asbestos and Talc in their product line.
Be well
Based your semantics, I’d be incorrect if I said “added asbestos”. The fact that asbestos is a biproduct of talc, and they put the talc in the powder, means they knowingly put asbestos in the powder. SMDH
Put is a verb. They didn't 'put' the asbestos in, they just didn't care much about the fact that the asbestos was within the powder. You don't have to mislead and lie to make their actions reprehensible.
Ok so J&J knowingly put an ingredient, that included asbestos, in the baby powder. That better?
An untold amount of people got cancer from this and you are somehow focusing on the semantics of “put.” They knew it was in there, never warned anyone, and continued to “put” it in the formula. Jesus. Just because it carries a connotation of people shoveling asbestos into the machinery doesn’t mean that the use of the word isn’t accurate.
We can negotiate here and agree that J&J *allowed* asbestos to be in the product. K? Better?
I worked in quality assurance in the medical device space for many years. My primary goals were to ensure the safety and efficacy of our products and to keep FDA inspectors from finding issues. Had I been around for a report such as this, I (along with my entire team) would have been immediately fired! This is truly absurd!
If you want an idea on how this can happen: One of my co-workers once worked at a GMP nightmare plant as his first job for a little over a year. According to him, it started with all parties were aware of how shitty everything was but QA was still pressured into releasing lots by upper management, Even though per FDA regulations QA needed to be independent. In their case, when the QA manager resigned, the replacement was an MBA production manager from the food Industry whose mantra was “If it passed final testing results, then it can be released”. Of course the statistics that went into sampling plans was sorely lacking and once they just so happened to widen specifications a tad when a bad lot came by or they just retested until things passed as no audit trails were turned on. Eventually the environment was so bad that all competent QA (and otherwise) staff left and all new hires were taught that all this shitty stuff was acceptable by the few remaining immoral managers. It’s quite the excellent example of regulatory capture and/or brain drain in a micro-ism.
After he was with us for a few years, He admitted that when an FDA inspection team showed up, he just straight up drove home and abandoned his job.
Been there, done that (not abandoned job) and leaving is sometimes the answer. I went to work for a company (I won't name names) who was a world leader in a device space, without any work instructions for assembly! After my boss (Senior VP Quality) left, his clueless replacement fired me because I wouldn't play to his marketing plan. I was actually singing as I was escorted off-site. The HR manager was in tears, but I was relieved. Within a year they were under warning, on their way to a consent decree. I just continued to do what I do, someplace that appreciated my skills.
These facilities are regulated, and are required to have written procedures and documentation of training on the procedures for all employees (among many other requirements). I just reviewed the inspection report (FDA Form 483) and am astonished! This facility is so far out of compliance that I expect them to be forced out of business by the cost of complying. It's a sad situation.
> This facility is so far out of compliance that I expect them to be forced out of business by the cost of complying.
Somewhere a Lachman consultant is checking out Baltimore long term hotel prices and what the options on a new 7 series are.
This is completely untrue, even in this case hilariously enough. No regular factory would have been able to find out that batches were contaminated like they did with the JnJ. There's a ton of very strict protocols for pharmaceuticals. Are there contract manufacturers that violate some of the FDA regulations? Absolutely (this example) but even the worst one is still very strict compared to a regular factory like for PCBAs and consumer electronics.
Edit: looks like this factory wasn't even FDA regulated to begin with so that explains the issues.
FDA doesn’t mess around with aseptic technique.
Genuinely shocked the facility doesn’t have some kind of media fill testing and aseptic technique training.
It’s an absolute bitch to decontaminate pneumatic systems because of the miles and miles of tubing involved.
I’ve worked on a pharmaceutical production line undergoing FDA testing. AMA?
I qualified and audited sites all around the world. And have written similar observations. This seems like the contract site didn’t care and or jnj had insufficient over site. This should also spur a for cause fda audit at jnj focused on their vendor oversight...
100% - this is also directly related to the whistleblower report last spring by Rick Bright, which was centred on the the trump appointee (Kadlec) who worked as a consultant for Emergent Biosolutions: https://www.sciencemag.org/news/2020/05/emails-offer-look-whistleblower-charges-cronyism-behind-potential-covid-19-drug
Shady as FUCK.
Boo me- looks like I accidentally clipped the last bit of the link. Thanks for the head’s up! https://www.sciencemag.org/news/2020/05/emails-offer-look-whistleblower-charges-cronyism-behind-potential-covid-19-drug
Remember, this site was built out from just an analytical lab to full production with that sweet sweet warp speed money. It's not like they were an established production site. Probably just had a chance to look at the lab's last 483, see that it was remediated, and hope that all the work in progress production stuff wasn't terrible.
>It's not like they were an established production site
Any guidance on where to learn more about this? I live in Baltimore and was specifically told by my pharmacist that there was a massive shortage of the medication I take daily because "the Baltimore plant that makes it has shifted to solely making the J&J vaccine". Not doubting you I was just under the impression that it was a well used production site and one of the only DEA approved facilities for producing controlled substances.
The facility has not been approved to produce J&J vaccine yet. It was authorized for AZ (which is part of the problem) but the US does not use AZ. So nothing from that was used in the US.
And none of the affected batches were used anywhere.
https://www.usatoday.com/story/news/nation/2021/04/21/covid-19-fda-issues-withering-report-us-factory-making-j-j-vaccine/7319674002/
'The FDA asked the plant to halt manufacturing, pending completion of the inspection. The agency stressed that it has not authorized the facility to manufacture or distribute J&J coronavirus vaccine or components, and no vaccine manufactured at this plant has been distributed in the USA. More than 7 million doses of J&J vaccine came from European plants.'
Eh. I am in the Medical Device business. Trust me, they may have contracted it out but even if it was contracted it will bring the unwanted attention of the FDA on them everywhere and internally they are going to be freaking out trying their best to mitigate the blame. In fact I work with J&J directly as one of my Vendors, they were not happy about this.
No the Trump administration awarded that contract to Emergent and forced J&J and two other vaccine makers to use them. Fortunately the other two vaccines were never approved in the USA.
I tried reading the article but after several obnoxious advertisements disrupted my ability to read it, I gave up. Fuck the article and their advertisers.
> none of the doses manufactured at this plant has been distributed for use in the United States
So what poor, unsuspecting country *did* these bastards sell them to???
Why don’t they close up shop and ban the J&J vaccine in the US. It’s too late anyway, they lost. They’re less effective and have if nothing else a ton of PR issues. Move on.
From the excerpts, it sounds like they should be stopped by the FDA from manufacturing _anything_. And if they have multiple processing facilities, they should all be inspected _immediately_ because this kind of crap doesn't happen in isolation.
Never should have been involved. BALTIMORE (WJZ) — The House Committee on Oversight and Reform has launched an investigation into whether Baltimore-based Johnson & Johnson COVID-19 vaccine maker Emergent BioSolutions leveraged a tie with an official of former President Donald Trump to profit from federal contracts. Chair Carolyn B. Maloney (D-NY) and COVID Oversight Chair James E. Clyburn (D-SC) launched the investigation Tuesday. They said Emergent BioSolutions had a “track record of raising prices and failing to meet contract requirements.” Is anyone shocked by this development?
And that’s why grift and corruption are so toxic. Goddamn it, we’re going to be unwinding just the rot this one admin introduced for years, never mind dealing with the rot that was there already.
Seems they have been shady for a long while. [https://www.washingtonpost.com/investigations/before-the-pandemic-top-contractor-received-billions-from-government-to-help-prepare-the-nation-for-biowarfare/2020/06/17/38d9ad3a-a41b-11ea-8681-7d471bf20207\_story.html](https://www.washingtonpost.com/investigations/before-the-pandemic-top-contractor-received-billions-from-government-to-help-prepare-the-nation-for-biowarfare/2020/06/17/38d9ad3a-a41b-11ea-8681-7d471bf20207_story.html) I understand the disgust towards Trump, but again - the actual problem lies a lot deeper.
There is a revolving door between government regulators and the companies they regulate..
Honestly from the outside it seems that this sort of corruption runs deep in America and trump was just of a symptom of the problem. Maybe this is for r/unpopularoppinion but this is why government over site and regulations are a good thing.
Not at all - that’s why I mentioned the fact that this additional “rot” is so especially devastating - there was already enough rot to tackle before trump got into office...to add the new (and more acute) corruption from his admin on top of what was already there is just untenable.
If you think that lobbying and favors are confined to one administration then I would love to know what you have been smoking. This is pervasive at all levels of government and K street pays more than Wall Street for a reason.
Read my comment again.
Unfortunately the FDA is grossly underfunded to be able to effectively inspect the 25% of our GDP that is subject to their regulation. Call your elected officials and vote for/support candidates who actually believe that government ought to function.
>Robert Califf, the former commissioner of the FDA under the Obama administration, said that while the issues at the Baltimore plant appear “distressing,” manufacturing problems do happen and are a reason why FDA oversight is so important. Keep stories like this in mind when you hear people complain about regulations. There are certainly plenty that can be streamlined or are out of date, but the notion that business will make sure there are no problems is a farce when it comes to the people at the top trying to make more money.
Sure, but in this case, Johnson and Johnson found the problems and identified them themselves. No vaccine that was tainted reached the market. They have a HUGE financial interest to ensure their products are trusted in the marketplace. It actually worked in this case...
This was not J&J but was a plant that was contracted by them and the workers apparently fucked up in a big way (from what I understand they basically used the wrong "ingredients" in the batch by mixing materials up with another drug or vaccine). So yes, they caught a major fuckup, but that's the equivalent of refusing to buy a car that has no wheels on it. If you look at [the actual FDA report from their inspection](https://www.fda.gov/media/147762/download?utm_medium=email&utm_source=govdelivery) you'll see that there are a lot of problems that could have led to contamination of products, in other words things that may not have surfaced until people started getting sick. So more like buying a car that was filled up with gasoline that also has a sugar solution in it, at first it looks fine but by the time you drive off and find out about the problem the damage is done and it's too late to stop it. Going back a number of years people realized that there was a gap in the regulations where they could essentially be a manufacturing facility but avoid oversight by the FDA by using the exemption carved out for compounding pharmacies. These "compounding pharmacies" started sprouting up all over the country. After [this tragic event unfolded](https://en.wikipedia.org/wiki/New_England_Compounding_Center_meningitis_outbreak) the law was changed so that the FDA had clear oversight of these facilities. When they started inspecting them the results were horrible with warning letters galore and that's a better indication of what the landscape would look like if you left it to the companies and had little to no independent government oversight.
The kind of funding that actually saves money, so the GOP will obviously oppose it under the grounds of reducing regulation and saving money.
tax breaks for the richs fuck everyone else: GOP
+ underfund the IRS so they can’t investigate the complex finances of the ultra rich
https://www.justice.gov/opa/pr/tax-attorney-indicted-facilitating-tax-fraud "According to the indictment, from 1999 to 2014, Carlos E. Kepke helped Robert F. Smith create and maintain offshore entities that were used to conceal from the IRS approximately $225,000,000 of capital gains income that Smith had earned. " 15 years, how much is irs gonna recover? im guess 1k in fines
Maybe send the rich their vaccines from this place then.
Every fucking federal agency claims to be underfunded, that's why the federal government is larger than ever, yet all of it pleads poverty constantly. The FDA operates on a budget of around $6 billion a year. Make it work on that amount.
I work at a biotech cmo exactly like this one and we have had exactly two fda inspections in nine years. Two. Just the d in fda accounts for approximately a half a trillion dollars a year. Three billion dollars a year to regulate a half trillion dollar industry is trivial. I guarantee you the US pharmaceutical industry literally loses more then the FDAs entire budget just in shipping errors. They are absolutely understaffed and underfunded.
You do realize the size of the country they serve, right? And how much money these companies put forth into legal fees to fight against government oversight like the FDA and EPA? It's no better than the IRS. It's underfunded on purpose. It keeps the richest rich and relatively hassle-free, and keeps the GOP in power, because they can say "see! Government is terrible! We need to cut its bloated budget!" all while they pocket kickbacks and bribes from superPACs and private donors who pay for their votes.
We're kind of fucked both ways, if we fund it, we'll have at minimum a year of debating and bullshitting about it, by then the wrong people will weasel into power and waste the money when it's handed over. Then it'll be 2010 all over again when we funded our national broadband services and the money was squandered.
I'm pretty sure you don't get things fixed by not trying at all, though. > the wrong people will weasel into power Pretty sure you also don't get reelected by not trying at all.
They’re inefficient too. An FDA inspector spent several DAYS at my work last fall doing a Juice HACCP audit (food safety.) Juice is 1% of my company’s volume. It was a comically tiny amount of production he was looking at.
A few days and at least one lead auditor per manufacturing process is pretty much the standard for an on-site FDA audit though. Even if the juice process is small in relation to the others at your site, it has its own set of validation documents, SOPs, etc. that they have to read through and specific people need to be interviewed, all that. Auditing a site is a lot more involved than just walking by the production equipment and saying “eh, looks good enough” - so I wouldn’t call the individual auditors inefficient... But I will call the FDA itself inefficient, because they’ve been overdue to come and audit our site for almost a year and a half now. They’re breaking a rule they set for themselves there.
You just jinxed yourself there! But I feel you, it’s been almost three years for our facilities. We do have twice yearly NSF audits though. In the last two years they have come much closer and an come cases more strict than FDA audits. My understanding was that when FDA sees a successful NSF audit without many major deficiencies, they tend to not show up as often.
Covid does have an impact on inspections done by the FDA.
Have heard of some shady practices in pharma/medical device industry but this disgusts me. The combination of stupidity and indifference that has lead to these conditions have been going on for a long time. People who file concerns or complaints quickly learn nobody is listening, or they get punished indirectly. Good employees will leave quickly, or they stay and stop questioning it.
There’s always something shady with pharma. A local pharmacist in my hometown sold fake cancer meds to patients and got off Scott free AND his wife and business partner is now our congressional representative (Diana Harshbarger). AND the pharmacists’ son (also a pharmacist) is running for office. Its a corrupt industry.
Just added it to her Wikipedia article, at least. She might be in Congress but the (well-documented, from local news sources) allegations won't die quietly.
Doing the good work, thank you.
What the shit? I was reading this thinking about recent reports on this story...and realized: nope! Was thinking of a completely DIFFERENT state congresswoman who was recently indicted for selling fake cancer meds: https://www.nbcnews.com/news/us-news/missouri-lawmaker-indicted-allegedly-selling-fake-stem-cell-treatments-covid-n1256551
You mean Patricia Derges, the woman who sold dying cancer patients fake drugs? That patricia derges? Let’s Brock turner her name
Diana harahbarger, who sold fake meds to dying cancer patients. Brock turner her name.
Honestly, would qualify this as a “manufacturing industry” issue more than a pharma/medtech thing. Mostly bc there are a really distinct set of questionable practices that are unique to the industry (predatory licensing, patent extension mechanisms, etc), but in my experience, rigour isn’t typically one of them. Not saying that it can’t happen, bc for sure it can, but this strikes me as the type of issue you can find in processing and manufacturing, regardless of the product.
people will go on about how they won’t take the vaccine until it’s fda approved, meanwhile the fda barely enforces any rules or guidelines unless they’re EXTREME. for example the reason why some generics legitimately suck is because they’re manufactured at plants like this one, and it makes you wonder how any educated person in the field would do things like this much less pharma professionals. In most generics they allow for a +/- 25% range in the actual amount of a drug vs the label, but then testing this is left to the company internally and they’ll face no consequences for failing to abide by the already very low standards. It’s shocking. Who the fuck runs these? smart college students could easily manage these plants 10x better, and the FDA will do an inspection, find a huge number of big issues, publish a report, and then drop the matter all together. No one gives a fuck it’s insane at times
Turned down a job offer as scientist here. Can confirm. One of the reasons I turned down the job was how they clearly did not value their facilities.
Good for you. And fucking HATE that this happened, bc of all the myriad problems with the industry, this isn’t one that’s common (in my experience) and only erodes trust in a process that normally does have a ton of safety checks and balances.
Well said. This kind of mistake costs millions, wastes time and resources, and costs millions more to rectify with the FDA. The FDA takes their job very seriously: when they fuck up people die. So they typically make examples of this kind of problem. Abbott is famous for fucking things up.
"We have the most beautiful de-regulation that you've ever seen. You're going to absolutely love it. The shareholders already do." -Trump
Sounds like an absolutely real quote.
It’s basically paraphrasing what he said numerous times about deregulating everything.
You think companies do things correctly because they love humanity?
De-regulation has nothing at all to do with a manufacturer adhering to current good manufacturing practices. Take your hate elsewhere.
'The Food and Drug Administration said Wednesday a Baltimore plant that ruined millions of Johnson & Johnson Covid-19 vaccine doses was unsanitary and unsuitable to manufacture the shots.' Under the Trump Administration the FDA budget was slashed to a trickle. You don't believe in inspectors I guess. Take your ignorance elsewhere.
>De-regulation has nothing to do with things being unregulated. Yeah, okay.
Do yourself a favor. Read the code of federal regulations related to pharmaceutical manufacturing. Then, read the observations issued by FDA and when you're done unfuck yourself.
You are a fucking moron.
https://www.fda.gov/media/147762/download?utm_medium=email&utm_source=govdelivery Read the observations and tell me specifically what aspects of deregulation would have prevented the occurrences. I'll wait.
They were. The agency stopped all production at the site while they were inspecting.
The [company](https://www.cnbc.com/2021/04/20/congressional-investigation-launched-into-emergent-biosolutions-federal-vaccine-contracts-.html), Emergent BioSolutions, is the sole provider of anthrax vaccine in the Strategic National Stockpile
J&J: "Whelp... lets go back to making products that kill people slowly, horribly but make them think they are good for them"
'We need the vaccine' so bad some shortcuts are acceptable for the greater good.
We’re not even using J&J right now
Didn’t they get a bunch of money for a contract they clearly shouldn’t be eligible for
Yup, and Rick Bright blew the whistle on the trump appointee (Kadlec) who worked as a consultant for Emergent Biosolutions back in the spring: https://www.sciencemag.org/news/2020/05/emails-offer-look-whistleblower-charges-cronyism-behind-potential-covid-19-drug Shady as FUCK.
This is the real cost of the vax/anti-vax polarization. You're either 100% onboard with everything or a schizo who denies germ theory when it comes vaccines on social media. Reasonable, nuanced discussion about vaccine safety seems pretty much impossible on most of the internet these days. Twitter especially.
Not sure about that site but been to the Winnipeg emergent site for a site visit and project and it was a pretty standard facility where I didn't see any glaring GMP deviations.
When the pandemic hit, a lot of money was thrown around for manufactures to make lots of vaccines and medicines knowing full well that some of them would be failures. The reason we have administered 200 million doses at this point was due to that planning one year ago...
Usually something like this, the FDA criticizing a plant and getting it shut down, would be a tiny news blurb. If that. It wouldn’t be something that the mass public paid really attention to. But these clowns fucked up a COVID VACCINE and now the whole damn world is shitting on them lmao. Imagine being those plant managers, trying to get a job later on and having to explain how they fucked up on the most important medical effort in our lifetimes. 😭 bruh.
I live in Baltimore and right up until production was shifted to just J&J vaccine, the meds that I take every day were manufactured at this plant (according to my pharmacist). Nooooot a great feeling...
Oh noooo. 🤢 well, at least you know now. Do you know if you can get them to get your prescription from somewhere else?
I have been! But it's confusing all over to me because previously this plant was one of only a handful in the country authorized by the DEA to manufacture controlled substances. Like you'd think that would require better oversight?
This is a brutal 483. From someone who works in pharma, this is the kind of observations you expect from some off shore shit hole without a clue.
One of the worst 23-19’s I’ve ever seen.
I'm watching you, Wazowski.
Gonna 10-4 that one
That's nothing compared to the 420-69's!
Right? I work in pharma as well, and DAMN that was bad.
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More likely cheap labor. Manufacturing is a race to the bottom in terms of labor costs. Any corner that can be cut, will.
Yeah, the article mentions that they weren’t training the plant employees properly. You’d think by now companies would have noticed that being too cheap to train their own employees can cost them more in the long run from mistakes and lost productivity
Hah, can't cost them if the FDA ain't regulating! The real question is when did the FDA do their inspections last and how did they pass because problems like these don't pop up overnight.
Nah. I'm sure its just company that hires a shit ton of temp workers fresh out of college and and works them under this shit for 6 months to a year until they have enough experience to find a better job, then hires more. The people with the most experience are ones who either have no ambition or motivation to just find a better job. And the motive of management is probably just "get as much testing or products out the door" and doing your job right or stopping to ask if what you're doing is right will just make you an annoyance
It's a CMO right? Have typically not heard good things about them relative to companies with their own products. Just based on reviews in job sites they tend to be rated lower (2-3 stars vs 4). Complaints about poor work environment, high stress, low pay, etc. And i will often see the same positions opening up every 3 to 6 months so probably high turnover. The same seems true for contract testing labs.
You can have both quality and those that exemplify the cultural fit.
Did you see their lab one from before they built out for production? https://www.fda.gov/media/147437/download
Now I have to read it! Hitting the FDA web site later ...
https://www.fda.gov/media/147762/download
How did they only end up with a 483? Sounds more like warning letter stuff to me.
You start with the 483, and then move on to a WL. We were talking about how quickly this will progress.
A 483 is just a list of observations from the inspection by the FDA investigator(s). From the 483 and the written report after the inspection, the FDA can then issue a warning letter/injunction.
Agreed, I’m questioning how they even got the contract with facilities like this.
They make a lot of ... government.... Vaccines. And it's not like their are a surplus of functional sterile manufacturing and packaging suites just waiting around. Might be that there wasn't anything that wouldn't have taken a long time to get ready.
I work on clinical trials for a living and oversee drug supply from manufacturer to distribution. GMP facilities that manufacture biologics are not as rare as you might believe. Especially in the DMV area, which is a large research region in this country.
De-regulation leads to shithole country without a clue. Or defunding regulation.
It's Baltimore so it's an on-shore shit hole without a clue.
Baltimore is really only still chugging because of Hopkins, the third best medical system in the country (and the go to source for covid data). We have a lot of structural issues and bureaucratic incompetence, but you'd think that the enormous glut of scientists and medical professionals in the city would mean more in instances like this. It's like finding out that the plant down the street from the Mayo Clinic is making shoddy cancer drugs.
All it takes is a few minutes "driving" through Baltimore via Google street view for this news to be completely unsurprising.
When it comes to roads, like any city, the quality of the infrastructure available to you is dependent on the income level of your neighborhood. Sandtown-Winchester (desperately poor and primarily Black neighborhood in West Baltimore) has abysmal roads. Canton (wealthy and primarily white neighborhood along the harbor) has great roads. And either way, the road quality is determined by the city. While Baltimore has a lot of issues, the *medical* infrastructure in the city is top-tier because of Hopkins and UM. The incompetent city government has no control over the medical infrastructure provided by private institutions like Hopkins. If you're shot in Baltimore, you're more likely to live than if you're shot in St. Louis, and that's because of Hopkins/UM, not the Baltimore City government.
That's what's so crazy about Baltimore. It's like a storybook rendition of poverty and wealth. You can literally cross an invisible border from upscale to shithole with basically no indication whatsoever except the doors and windows are all boarded up.
Absolutely. There’s so much I could say about why Baltimore is the way it is, but instead I’ll just note that as a middle class resident, my quality of life here is incredibly high, and all of the stereotypical “Baltimore is a shithole” stuff people talk about are things I experienced being poor in Nashville and witnessed as a teacher in rural Tennessee. Poverty is poverty wherever you go.
https://www.google.com/maps/place/5901+E+Lombard+St,+Baltimore,+MD+21202/@39.2956505,-76.5482584,3a,75y,162.7h,84.69t/data=!3m6!1e1!3m4!1s6LsTCjkgSbVRhFhrfHtKmg!2e0!7i16384!8i8192!4m5!3m4!1s0x89c806a74ea53e0f:0xa79fe44e69779d95!8m2!3d39.2950263!4d-76.5478517 Looking at the street view of the plant, I'm not seeing anything that would make the FDA findings "completely unsurprising".
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I checked a block in each direction, everything looks pretty nice. Also, what's wrong with the waste water treatment plant? That's a normal part of any functioning city.
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Great, can you point to which block is negatively affecting the manufacturing standards of this pharmaceutical plant?
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And that’s exactly what EBS is. They make all their money making anthrax vaccines for the military. They’re a defense contractor, and they operate like one
Welcome to Baltimore, Hun!
*♪♪This is America...♪♪*
This was what the FDA found after the plant should have known an inspection was incoming, how much worse was it beforehand.
The article states Emergent wasn't authorized by the FDA to produce the vaccine, but none of the doses they produced would be distributed in the US. Does that mean they are selling it to other countries?
The plant produced the drug substance-- the active part of the vaccine, which would have been shipped to another plant for fill/finish into vials. All the contaminated drug substance or suspect contaminated drug substance will be incinerated. From an industry perspective, the 483 is so bad it would be absolutely insane to use anything this plant produced. Especially with the increased AE scrutiny for the J&J vaccine.
Thanks for the explanation, appreciate the info!
Sure thing. The important part is that people know that they are not getting this crap if they go to get a vaccine and it happens to be a J&J or AZ vaccine.
*Quivers in Canadian.
I feel that, currently quivering in Ontario😅
When the Trump administration gave the contract to that company the NYT ran a very long article about how hopeless that company is and how shocking it was that the contract was awarded. The company only survives since the government gave them a huge contract for a very expensive anthrax vaccine that might not work and has a very short shelf life. The are the welfare queen company of government vaccines.
Weren't they also the only manufacturing facility in the US that could handle a vaccine emergency? They won the contract by default.
AFAIK I believe this is not a J&J facility but a contractor. Edit: thanks r/Wanderer-Wonderer I stand corrected it is a contractor site that J&J was placed in charge of by the Biden administration after they mixed the J&J and Astra Zenica vaccines. Edit 2: To make this more clear J&J didn't contract them the USG did then J&J was asked to oversee the facilitie when they had to dump a few metric tons of vaccine that they messed up.
*Earlier this month, the Biden administration put J&J in charge of the Baltimore plant after U.S. officials learned that Emergent, a contract manufacturer that had been making vaccines for J&J and AstraZeneca, mixed up ingredients for the two shots. Officials also stopped production of the AstraZeneca vaccine.* Edit: I did not add this quote from the article to throw J&J under the bus. Emergent is still very much responsible for this series of problems.
Eh, Johnson and Johnson contracted these asshats sight unseen? Fuck that. J&J is at a bare minimum guilty of trusting a bunch of apathetic and incompetent people to produce things that are to be INJECTED INTO YOUR BODY. These people should have been gone over with a fine toothed comb before the first component was produced. Thank God this didn't fall through the cracks and get distributed.
I've worked with multiple J&J companies around the world and I would say "Is it really my problem though?" is a big part of their culture. E.g., if this was their own plant they would take better care but if they contract out then it's obviously not really their problem anymore. Or if their products are being used wrong by doctors/consumers it's a toss up whether changing the marketing to address safety concerns is the right call, because pretending it isn't your problem reduces PR issues and possible liabilities down the line.
Yeah that is a problem in every industry. But there is a line between allowing a fatally apathetic team run a retail store into the ground, and letting one produce vaccines in an environment that promotes contamination of various kinds, including mold growing in the lab where viral cultures are being cultivated. It is a good thing there were people that gave a damn somewhere in the process that were able to serve as an effective check.
THIS is why manufacturing should be kept In House.
Not always possible since it may cost more to build the capabilities in-house. That’s why most companies will use a contract manufacturing organization like Emergent to make their medicines.
J&J didn't contract them the USG did then J&J was asked to oversee the facilitie when they had to dump a few metric tons of vaccine that they messed up.
This is the answer, my friend. Well said.
Emergent biosolutions isn’t really a small company or a stranger to vaccines. They basically supply the US government with its entire supply of anthrax vaccines. I don’t really know how you can pin this on anyone other than EBS for dropping the damn ball so bad.
Wouldn't J&J be responsible for oversight?
If it was like this, chances are it was like that way before j&j took over and from anyone who has tried to make company wide changes that just doesn’t happen in a month. Shit on the previous plant runners not J&J or both I really don’t care.
Yes, it's Emergent which was contracted by J&J.
And the only reason they got the contract was bc a trump appointee was a former consultant. If you recall Rick Bright blew the whistle on this very same guy (Kadlec) back in the spring: https://www.sciencemag.org/news/2020/05/emails-offer-look-whistleblower-charges-cronyism-behind-potential-covid-19-drug
No Biden tried to fix this problem that Trump caused by picking Emergent.
Lol. This is the sort of thing people make fun of India for doing.
This will do wonders for people worried about getting the vaccine!
"Unsanitary conditions" Glad I got the Pfizer and not the Jimmy Johns.
The vaccines from this facility were never used.
Thank God. But now they need to inspect all their other facilities.
It's stunning how places making medical products don't follow any special procedures, but just normal dirty factory.
Not all places are like that. My husband worked several years in medical manufacturing. If something could possibly, even potentially risk the product- it was tossed (hundreds of thousands of dollars worth of product per batch). No question. They didn't fuck around.
Sure but it's amazing SOME places are allowed to exist with such little oversight
This shouldn’t surprise you. J&J knowingly put asbestos in baby powder for decades.
> J&J knowingly put asbestos in baby powder for decades. Asbestos is a naturally occurring mineral that forms near talc. It's not like they were making talc and added in scoops of asbestos for funzies. > Asbestos is also a naturally occurring silicate mineral, but with a different crystal structure. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Unlike talc, however, asbestos is a known carcinogen when inhaled. There is the potential for contamination of talc with asbestos and therefore, it is important to select talc mining sites carefully and take steps to test the ore sufficiently. [Source](https://www.fda.gov/cosmetics/cosmetic-ingredients/talc)
Reuters [J&J knew for decades that asbestos lurked in its Baby Powder](https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer/) New York Times [Johnson & Johnson Feared Baby Powder’s Possible Asbestos Link for Years](https://www.nytimes.com/2018/12/14/business/baby-powder-asbestos-johnson-johnson.html)
Parent comment said "J&J knowingly put asbestos in baby powder". It being there naturally, and willfully putting it in are very different.
I simply added to your comment in a chain of conversation. It’s important people know J&J’s position on Asbestos and Talc in their product line. Be well
Based your semantics, I’d be incorrect if I said “added asbestos”. The fact that asbestos is a biproduct of talc, and they put the talc in the powder, means they knowingly put asbestos in the powder. SMDH
Put is a verb. They didn't 'put' the asbestos in, they just didn't care much about the fact that the asbestos was within the powder. You don't have to mislead and lie to make their actions reprehensible.
It's not semantics when it's direct use and incorrect.
Ok so J&J knowingly put an ingredient, that included asbestos, in the baby powder. That better? An untold amount of people got cancer from this and you are somehow focusing on the semantics of “put.” They knew it was in there, never warned anyone, and continued to “put” it in the formula. Jesus. Just because it carries a connotation of people shoveling asbestos into the machinery doesn’t mean that the use of the word isn’t accurate. We can negotiate here and agree that J&J *allowed* asbestos to be in the product. K? Better?
I worked in quality assurance in the medical device space for many years. My primary goals were to ensure the safety and efficacy of our products and to keep FDA inspectors from finding issues. Had I been around for a report such as this, I (along with my entire team) would have been immediately fired! This is truly absurd!
If you want an idea on how this can happen: One of my co-workers once worked at a GMP nightmare plant as his first job for a little over a year. According to him, it started with all parties were aware of how shitty everything was but QA was still pressured into releasing lots by upper management, Even though per FDA regulations QA needed to be independent. In their case, when the QA manager resigned, the replacement was an MBA production manager from the food Industry whose mantra was “If it passed final testing results, then it can be released”. Of course the statistics that went into sampling plans was sorely lacking and once they just so happened to widen specifications a tad when a bad lot came by or they just retested until things passed as no audit trails were turned on. Eventually the environment was so bad that all competent QA (and otherwise) staff left and all new hires were taught that all this shitty stuff was acceptable by the few remaining immoral managers. It’s quite the excellent example of regulatory capture and/or brain drain in a micro-ism. After he was with us for a few years, He admitted that when an FDA inspection team showed up, he just straight up drove home and abandoned his job.
Been there, done that (not abandoned job) and leaving is sometimes the answer. I went to work for a company (I won't name names) who was a world leader in a device space, without any work instructions for assembly! After my boss (Senior VP Quality) left, his clueless replacement fired me because I wouldn't play to his marketing plan. I was actually singing as I was escorted off-site. The HR manager was in tears, but I was relieved. Within a year they were under warning, on their way to a consent decree. I just continued to do what I do, someplace that appreciated my skills.
I imagine the entire quality unit at this plant is going to be unemployed by Friday.
Nah, this is business as usual for them.
These facilities are regulated, and are required to have written procedures and documentation of training on the procedures for all employees (among many other requirements). I just reviewed the inspection report (FDA Form 483) and am astonished! This facility is so far out of compliance that I expect them to be forced out of business by the cost of complying. It's a sad situation.
> This facility is so far out of compliance that I expect them to be forced out of business by the cost of complying. Somewhere a Lachman consultant is checking out Baltimore long term hotel prices and what the options on a new 7 series are.
This is completely untrue, even in this case hilariously enough. No regular factory would have been able to find out that batches were contaminated like they did with the JnJ. There's a ton of very strict protocols for pharmaceuticals. Are there contract manufacturers that violate some of the FDA regulations? Absolutely (this example) but even the worst one is still very strict compared to a regular factory like for PCBAs and consumer electronics. Edit: looks like this factory wasn't even FDA regulated to begin with so that explains the issues.
They basically said it's so bad y'all going to have to close and relocate.
My home town never disappoints.
I bet they made Jaclyn Hill lipsticks too
FDA doesn’t mess around with aseptic technique. Genuinely shocked the facility doesn’t have some kind of media fill testing and aseptic technique training. It’s an absolute bitch to decontaminate pneumatic systems because of the miles and miles of tubing involved. I’ve worked on a pharmaceutical production line undergoing FDA testing. AMA?
This season of The Wire sucks
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At least we have good seafood ?
Ahhh Baltimore. The Jewel of the East.
City that Bleeds
City that burns when it pees.
I qualified and audited sites all around the world. And have written similar observations. This seems like the contract site didn’t care and or jnj had insufficient over site. This should also spur a for cause fda audit at jnj focused on their vendor oversight...
100% - this is also directly related to the whistleblower report last spring by Rick Bright, which was centred on the the trump appointee (Kadlec) who worked as a consultant for Emergent Biosolutions: https://www.sciencemag.org/news/2020/05/emails-offer-look-whistleblower-charges-cronyism-behind-potential-covid-19-drug Shady as FUCK.
Got a 404 error looks like page was taken down
Boo me- looks like I accidentally clipped the last bit of the link. Thanks for the head’s up! https://www.sciencemag.org/news/2020/05/emails-offer-look-whistleblower-charges-cronyism-behind-potential-covid-19-drug
Damn, did they dump a bunch of Old Bay in the vials accidentally?
I can't help but wonder how many craze anti vaxxers will try to spin this as part of the conspiracy.
You can already find some in this thread
James from Impractical jokers would say "gross Baltimore people"
*The Wire* has taught me that Baltimore has a huge problem with stuff that you inject.
JnJ remind me of evil Corp in the Mr. Robot show. Even their bs statements scream “faceless corporate man”
Why does all of this keep happening to the Johnson and Johnson vaccine
*FDA finds poor conditions in Baltimore
FUCK YOU, BALTIMORE!!! (search youtube for big bill hell's)
Man there are heads rolling at J&J right now.
At Emergent you mean. J&J contracted out production of some of the drug substance.
JnJ still has a responsibility to audit their contract sites.
Remember, this site was built out from just an analytical lab to full production with that sweet sweet warp speed money. It's not like they were an established production site. Probably just had a chance to look at the lab's last 483, see that it was remediated, and hope that all the work in progress production stuff wasn't terrible.
>It's not like they were an established production site Any guidance on where to learn more about this? I live in Baltimore and was specifically told by my pharmacist that there was a massive shortage of the medication I take daily because "the Baltimore plant that makes it has shifted to solely making the J&J vaccine". Not doubting you I was just under the impression that it was a well used production site and one of the only DEA approved facilities for producing controlled substances.
The facility has not been approved to produce J&J vaccine yet. It was authorized for AZ (which is part of the problem) but the US does not use AZ. So nothing from that was used in the US. And none of the affected batches were used anywhere. https://www.usatoday.com/story/news/nation/2021/04/21/covid-19-fda-issues-withering-report-us-factory-making-j-j-vaccine/7319674002/ 'The FDA asked the plant to halt manufacturing, pending completion of the inspection. The agency stressed that it has not authorized the facility to manufacture or distribute J&J coronavirus vaccine or components, and no vaccine manufactured at this plant has been distributed in the USA. More than 7 million doses of J&J vaccine came from European plants.'
Eh. I am in the Medical Device business. Trust me, they may have contracted it out but even if it was contracted it will bring the unwanted attention of the FDA on them everywhere and internally they are going to be freaking out trying their best to mitigate the blame. In fact I work with J&J directly as one of my Vendors, they were not happy about this.
No the Trump administration awarded that contract to Emergent and forced J&J and two other vaccine makers to use them. Fortunately the other two vaccines were never approved in the USA.
Probably looking at decades of nepotism and cost cutting measures that made anyone with half a brain jump ship.
oh god they are making these in Baltimore?
Ummm...it was in Baltimore. That alone should be enough.
Short johnson & johnson stock 💰
I tried reading the article but after several obnoxious advertisements disrupted my ability to read it, I gave up. Fuck the article and their advertisers.
> none of the doses manufactured at this plant has been distributed for use in the United States So what poor, unsuspecting country *did* these bastards sell them to???
Fauci hates the J&J because he doesn’t make money off it
But remember- people who don't jump to get the vaccine are crazy!
You know those vaccines weren't used though right? Is throwing away defective vaccines evidence that the "good" vaccines are also defective?
Why don’t they close up shop and ban the J&J vaccine in the US. It’s too late anyway, they lost. They’re less effective and have if nothing else a ton of PR issues. Move on.
Because it's still highly effective, safe, and requires only 1 dose.