Have you tested positive for COVID?

[Centrals]

That’s a contradiction! Eliminating red tape makes a process more efficient. Not a shortcut. You need to better understand the definition of red tape.

Reminding me of changing Indian Rupee back to hard currency all those yrs ago in India. The whole process took 5 persons spreading over 2 floors and 45 mins!!!!!

 

[Centrals]

Did you just call everyone who's been infected an idiot?

Everyone? NO but there are plenty of them at the White House.

 

[HalcyonDaze]

Well it is official. The FDA has granted EUA for the Pfizer mRNA covid vaccine. If anyone is interested here is the letter...

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

"In the Pipeline" has some pretty good breakdowns of the various vaccine results posted so far (and in less trying times, the "Things I Won't Work With," "Things I'm Glad I Don't Do," and "How Not to Do It" categories are a hoot to read): https://blogs.sciencemag.org/pipeli.../the-fda-weighs-its-first-coronavirus-vaccine

Frank, hope you're doing okay. My sister and her husband both had covid in September; despite both being nurses they got it from what I like to call the "Spaceballs Infection Chain" - i.e., stepson's girlfriend's college roommate had it, gave it to the girlfriend, girlfriend gave it to the stepson, stepson gave it to his father, father brought it home to my sister. They're both healthy folks in their mid-late 40s and it knocked them flat for a few weeks. I'm all for taking an FDA-approved vaccine; granted until they decide an environmental consultant who was considered "essential" enough to go back to working out of the office and with clients April 3 is "essential" enough to get it I'll just have to keep bobbing and weaving.

 

[Bottom Surveyor]

So which is it? They skipped steps on this vaccine, making it less safe than others, or they never do those steps to ensure safety for anything?

The answer to your question lies in this sentence:

“The long list of drug recalls on FDA website is evidence that still industries are not following the standard guidelines issued by FDA,” doctors Upendra Nagaich and Divya Sadhna wrote in a study published in 2015 in the International Journal of Pharmaceutical Investigation.

FDA Recalls - How Dangerous Drugs & Devices are Recalled

So, if this happen all the time (when pharma companies are not pressed for time), what is the likelihood of their getting it right when they are, like they are now?

Therefore, the answer to your question is: both. They don't strictly adhere to the FDA guidelines even when they have the time. And now that they don't... Well, you draw your own conslusion. At stake is only your health, and that of your family.

And bear in mind that it is not me who is saying this - it is medical scientists.
You are entitled to your own opinion, but not to your own facts. But if you don't like the message, you can always shoot the messenger, I guess.

As to the latter point, yes, some drugs etc pass the initial safety screening but then are later recalled.

Sure, this new arthritis medication may work better,

It's not just "some" drugs. It's the sheer number of them. 4500 on a yearly bases; it's a mind - boggling figure.

As a consumer, it is important to be aware of devices or drugs that may affect your health. In 2017 alone, manufacturers recalled 4,402 drug and device products, according to the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research. Of those recalls, the FDA classified 139 as Class I. Class I recalled products have the potential to cause serious harm or death.

FDA Recalls - How Dangerous Drugs & Devices are Recalled

So on average, almost every 2 days a drug that has the potential to cause serious harm or death is withdrawn from use.

So were pregnant women. So were children. Those typically are studied and reported later, if at all, for most medications.

Quite right. Here's for instance what can happen when a medication doesn't get tested properly. It was given to pregnant women, causing horrifying consequences:

You can only choose whether to take a vaccine developed in accordance with established protocols, or take your chances with the virus. But it's also not just about you--it's about everyone you might spread it to.

If you choose to take the vaccine, then surely, you will be protected and won't have to fear that I will infect you?
Others who opt out (as I shall, in the early stages), are going to be in the same boat as me. So, there's nothing unethical about my choice.

 

[divinh]

It's not just "some" drugs. It's the sheer number of them. 4500 on a yearly bases; it's a mind - boggling figure.

FDA Recalls - How Dangerous Drugs & Devices are Recalled

So on average, almost every 2 days a drug that has the potential to cause serious harm or death is withdrawn from use.

4500 drugs? Or "Drugs & Devices"? What's included in "Drugs & Devices"? This?

(from article) "FDA-Regulated Products Subject to Recall Include:

• Human and animal drugs
• Medical devices
• Vaccines
• Blood and blood products
• Radiation-emitting products
• Transplantable human tissue
• Animal feed
• Cosmetics
• Food"

Or a subset? It would be nice if there was a breakdown to show how many of those recalled were vaccines.

(from article) "In 2017 alone, manufacturers recalled 4,402 drug and device products, according to the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research. Of those recalls, the FDA classified 139 as Class I. Class I recalled products have the potential to cause serious harm or death."

139 Class I doesn't equate to "almost every 2 days a drug that has the potential to cause serious harm or death is withdrawn from use".

 

[divinh]

A friend recently had it. She went to the doctor and had an oximeter reading of 94% and went home to quarantine. On Thanksgiving Day, her oximeter dropped to 86%, so she went to the hospital, where they admitted her immediately and she spent a week there. They put her on oxygen and had her on her stomach at times, to keep her lungs clear. She had no time to arrange anything. Her two cats survived the week, thankfully. She's still on the mend after being released. Her advice is to make plans if you have dependents, as you might go from being okay to needing hospitalization pretty quickly.

 

[Storker]

@Bottom Surveyor , I think you're partly on the right track, but way off base with your arguments.

Yes, nearly all medications have side effects. Some are inconsequential, others may be grave. And not all side effects are discovered during the testing phase, some of those because they're so rare that they're statistically unlikely to show up in a test cohort of limited size. Yes, some companies have cut corners, that's bound to happen when enough people have an interest in getting their product on the market, some of them will lack the necessary ethics.

I didn't watch the Youtube video you linked to, because it requires sign-in to watch. But from the context, I guess it's about the thalidomide scandal. Now, as far as I know, thalidomide is teratogenic only to humans. So how do you discover that a teratogenic drug is teratogenic only by giving it to pregnant women with the purpose to check if the kids turn out okay or will be malformed? I don't think there's even one ethics board which would allow a study like that. So the results will come out after the drug has been approved.

Your arguments against the Coronavirus vaccines remind me uncomfortably of anti-vax arguments. And I hate anti-vax with a vengeance. We were on the brink of eradicating measles (an extremely contagious disease, so contagious that effectively every child was bound to get it, with a mortality rate of 0.1-0.2%) in the industrialized world until Andrew Wakefield published his bogus "study". A fake "study" published so that Andrew Wakefield could make money and which, long time after its withdrawal is still fuelling the anti-vax stupidity. Now we see measles becoming more widespread, and children are dying unnecessarily. That's what happens if we dig trenches and roll out the heavy artillery in the discussion.

I agree that waiting to get the shot until it has been more extensively "tested" in regular use isn't in itself unethical provided the person who chooses to do so takes all other necessary measures like socially distancing, using PPE if they come within a 2m distance from anyone else and being really anal about hand hygiene. And perhaps totally avoiding any kind of contact with anyone who might be at risk. But only in that case.

 

[Bottom Surveyor]

139 Class I doesn't equate to "almost every 2 days a drug that has the potential to cause serious harm or death is withdrawn from use".

Primary school maths show that it's 2.62 days. So, yes, it's almost every 2 days. Sorry.
Unless you really want to be splitting hairs, in which case we can call it almost 2 1/2 days.

4500 drugs? Or "Drugs & Devices"

In my original post where I linked to the findings, I did write "drugs and devices". You can find it if you want. This time I abbreviated it.

But why are you looking to split hairs? I assume that to those who end(ed) up being harmed, it doesn't matter too much whether what harmed them was a dodgy vaccine, a drug, or a device.

 

[divinh]

Primary school maths show that it's 2.62 days. So, yes, it's almost every 2 days. Sorry.
Unless you really want to be splitting hairs, in which case we can call it almost 2 1/2 days.

Yes, drugs & devices, not just vaccines, which is what the discussion is about.

In my original post where I linked to the findings, I did write "drugs and devices". You can find it if you want. This time I abbreviated it.

But why are you looking to split hairs? I assume that to those who end(ed) up being harmed, it doesn't matter too much whether what harmed them was a dodgy vaccine, a drug, or a device.

How many of the 4500 are vaccines? How many of the 139 are vaccines?

 

[divinh]

CDC "Historical Vaccine Safety Concerns"

Historical Safety Concerns | Vaccine Safety | CDC

"Cutter Incident - 1955
Simian Virus 40 (SV40) - 1955-1963
Swine Flu Vaccine and Guillain-Barré Syndrome - 1976
Hepatitis B Vaccine and Multiple Sclerosis - 1998
Rotavirus Vaccine and Intussusception - 1998-1999
GBS and Meningococcal Vaccine - 2005-2008
Hib Vaccine Recall - 2007
H1N1 Influenza Vaccine and Narcolepsy - 2009-2010
Porcine Circovirus in Rotavirus Vaccine - 2010
HPV Vaccine Recall - 2013"

Note that these are concerns and not all of them led to recall or stoppage of use. More details on the CDC website.