> Side effects don't have to happen in the next 6 months.
If this is a molecule with a short half-life that is broken down and expelled by the body, it isn't going to have random side effects that show up months in the future.
If this is a molecule with a short half-life that is broken down and expelled by the body, it isn't going to have random side effects that show up months in the future.
Do I think that is likely? No, because the FDA isn’t stupid and screens for obvious toxicity in cell cultures and lab animals and only then is testing humans allowed. Then those are screened before approval.
Of course the risk isn’t 0%, but it’s pretty low and if you’re at chance of dying or Covid it’s a pretty small risk relatively speaking.
That's why I said if, I know nothing about the molecule.
I'm just playing devil's advocate, but it doesn't seem impossible.
If you have something specific about this particular molecule to talk about vis a vis safety, that's an interesting comment to make. But "aspirin is a molecule but so is Mad Cow Disease so we had better be careful about new drugs" is just about the most boring, banal comment you can make. Drugs: can they be unsafe??? We'll have more at 11!
We need more Derek Lowe-type drug safety discussion here, and a lot less of whatever this is.
And Pfizer isn't the hero here, they never have been.
https://corporatewatch.org/pfizer-six-scandals-to-remember/
This list doesn't even include Celebrex.
1986: Pfizer had to withdraw an artificial heart valve from the market after defects led to it being implicated in over 300 deaths. The US Food and Drug Administration (FDA) withdrew its approval for the product in 1986 and Pfizer agreed to pay hundreds of millions of dollars in compensation after multiple lawsuits were brought against it.
2003: Pfizer has long been condemned for profiteering from AIDS drugs. In 2003 for example, it walked away from a licencing deal for its Rescriptor drug that would have made it cheaper for poorer countries.
2011: Pfizer was forced to pay compensation to families of children killed in the controversial Trovan drug trial. During the worst meningitis epidemic seen in Africa, in 1996, Pfizer ran a trial in Nigeria their new drug Trovan. Five of the 100 children who took Trovan died and it caused liver damage, while it caused lifelong disabilities in those who survived. But another group of 100 children were given the conventional “gold standard” meningitis antibiotic as a “control” group for comparison. Six of them also tragically died because, the families said, Pfizer had given them less than the recommended level of the conventional antibiotic in order to make Trovan look more effective.
2012: Pfizer had to pay around $1billion to settle lawsuits claiming its Prempro drug caused breast cancer. Prempro was used in hormone replacement therapy, usually for women going through the menopause. The settlements came after six years of trials and hardship for the women affected.
2013: Pfizer paid out $273 million to settle over 2,000 cases in the US that accused its smoking treatment drug Chantix of provoking suicidal and homicidal thoughts, self harm and severe psychological disorders. Pfizer was also accused of improperly excluding patients with a history of depression or other mental disturbances from trials for the drug. Later, in 2017, a coroner in Australia ruled that the drug had contributed to a man’s suicide. The man’s mother campaigned to change the label on the drug.
2020: Pfizer reached an agreement with thousands of customers of its depo-testosterone drug in 2018 after they sued it for increasing the likelihood of numerous issues, including heart attacks.
>very small amount of a substance can cause catastrophic effects a decade later.
Medication failure modes are either short-term acute and found in test quickly, like Trovan example; or where long-term ingestion causes problems.
All of your examples are one of those two.
https://en.wikipedia.org/wiki/Thalidomide_scandal
The total number of people affected by the use of thalidomide during the mother's pregnancy is estimated at more than 10,000, of whom approximately 40 percent died at or shortly after the time of birth. Those who survived had limb, eye, urinary tract, and heart defects [...] The severity and location of the deformities depended on how many days into the pregnancy the mother was before beginning treatment; thalidomide taken on the 20th day of pregnancy caused central brain damage, day 21 would damage the eyes, day 22 the ears and face, day 24 the arms, and leg damage would occur if taken up to day 28. Thalidomide did not damage the fetus if taken after 42 days' gestation.
So the previous poster's question about drugs given for a short time causing long delayed effects and approved in the last 20 years stands. If a drug is not a mutagen, it is harder to imagine how it could have a long-term effect.
I absolutely agree that they could have tested for certain things but didn't. It's a product of its time in that sense:
One reason for the initially unobserved side effects of the drug and the subsequent approval in West Germany was that at that time drugs did not have to be tested for teratogenic effects. They were tested on rodents only, as was usual at the time
While initially considered safe, the drug was responsible for teratogenic deformities in children born after their mothers used it during pregnancies, prior to the third trimester. In November 1961, thalidomide was taken off the market due to massive pressure from the press and public
I doubly apply to medications that can potentially eff your one body/mind you have up for good what I practice in software development and try to teach my teams: assumptions make an ass out of you and me.
If a drug is not a mutagen, it is harder to imagine how it could have a long-term effect.
And yes, that's (one reason) why the recommendations for the Covid vaccine were not given for pregnant women at first.
The point wasn't that there are drugs known to be dangerous to pregnant women (mainly the unborn child). The ask was for an approved drug that caused delayed death.
There were definitely so many things going wrong w/ that specific drug but it serves as a really good example for why all these precautions are taken and should be taken and any new drug should not be presumed safe but presumed dangerous and proven to not be harmful. The specific time frames and measures can of course be debated to find a good spot on the spectrum and an active pandemic can influence the choices. The discussion was going in the direction of some posters saying we should assume safe first and the Contergan case very clearly shows why assuming safety is the wrong choice.
Are there any authorized or approved drugs that are taken over a short-term (say less than a month) that have been shown to cause long-term death?
authorized or approved.
taken over a short-term (say less than a month)
cause long-term death
Nowhere in there does it say to exclude any drugs than only cause direct death to the taker. Nor do I think should that matter. I do agree that pregnant women are studied separately precisely because the risks there are higher. To quote from the wikipedia article again:
The Society of Toxicology of Canada was formed after the effects of thalidomide were made public, focusing on toxicology as a discipline separate from pharmacology. The need for the testing and approval of the toxins in certain pharmaceutical drugs became more important after the disaster.Now you asked a new question. Fair enough. Unlike the previous question, where Contergan immediately jumped to my mind, for your question nothing jumps to mind. But google helped. I think you wanted to ask a different question, more like what I originally answered to, e.g.:
Can you name any approved drug that, that when taken over a short course, can over the long term cause the death of the person taking it?
Can you name any drug that, when taken over a short course, has had long term detrimental effects to the person taking it?
Let's take that apart:
name any drug
The UK Department of Health's Rolleston Committee Report in 1926 established the British approach to diamorphine prescription to users, which was maintained for the next 40 years: dealers were prosecuted, but doctors could prescribe diamorphine to users when withdrawing. In 1964, the Brain Committee recommended that only selected approved doctors working at approved specialized centres be allowed to prescribe diamorphine and cocaine to users. The law was made more restrictive in 1968. Beginning in the 1970s, the emphasis shifted to abstinence and the use of methadone; currently, only a small number of users in the UK are prescribed diamorphine.
taken over a short term
However, contrary to Bayer's advertising as a "non-addictive morphine substitute," heroin would soon have one of the highest rates of addiction among its users.
long term detrimental effects to the person taking it
Common side effects include respiratory depression (decreased breathing), dry mouth, drowsiness, impaired mental function, constipation, and addiction.[12] Side effects of use by injection can include abscesses, infected heart valves, blood-borne infections, and pneumonia.[12] After a history of long-term use, opioid withdrawal symptoms can begin within hours of the last use.
So I’ll ask a third time, hoping that perhaps finally I can get you to the original asker’s intention:
Can you name any drug that when taken for only a short period of time, like this Covid drug surely would be, and is non addictive like this Covid drug surely is not, is harmful in the long term to the person who took it (assuming they are not pregnant as all of the people who would be allowed to take it would not be)?
Remember all those war movies? I remember watching Vietnam war movies as a kid and one of the things I remember best is the use of morphine as _the_ field medicine.
Now we can argue that, especially in those times, it might be better to give a soldier that just lost a limb in the battlefield morphine than not to. It doesn't change the fact that
https://www.onceasoldier.org/veteran-ptsd-and-opioid-addicti...
The VA and other reports acknowledge that physicians need better training to manage opioid treatment for veterans. Between 2001 and 2009, for example, the percentage of veterans receiving pain management with prescription narcotics increased from 17 percent to 24 percent. The number of opioid prescriptions written by military physicians more than quadrupled during that time.If we're applying the COVID standard to Pfizer, would their failure rate be greater than or less than COVID's death rate?
If we use the 2% number I've seen around here for COVID's death rate, that means if Pfizer has over 300 drugs, these six scandals are a non-issue because they happen so rarely.
But l add the death rate according the administration is around 0.5% from the latest stats due to lack of testing.
Some people seem determined to do anything except take precautions laid out by infectious disease experts and take medicine specifically for this virus. And they're looking for any excuse to do so.
It’s why we don’t look at a molecule and say “oh, that’s not a carcinogen! No need to test”. And the same reason we run hERG tests to make sure drugs don’t give you a fatal arrhythmia (a surprising number of drugs do this and some are still on the market).
And funny you should say 10-25 years. 10 years is pretty typical from initial molecule discovery to FDA approval.
I was referencing your assertion that all molecules are prions until proven otherwise.
Also, I asked two questions. Next time try answering them before jumping to being an ass.
And please show us the words where where the poster claimed that “all molecules are prions”…as you claimed. I can point to your exact words here…look forward to you doing the same.
According to whom? You make it sound as if at some point scientists thought that prions were "just proteins", which I'm sure is not true.
I'm not saying new medicine can't have side effects a long time after ingestion.
https://rxisk.org/post-ssri-sexual-dysfunction-pssd/
There are plenty of drugs with long term effects despite not remaining in the body. Every addictive substance comes to mind, but so do chemotherapies and many other things.