[darthvoldemort]

I'm suggesting that sometimes a very small amount of a substance can cause catastrophic effects a decade later. That's why we do testing before we release drugs.

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.

[KptMarchewa]

There is nothing here that suggests that:

>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.

[jdavis703]

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?

[tharkun__]

This immediately jumped to mind (Contergan):

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 ~280 days for a pregnancy, minu 21-41 still leaves way more than half a year after taking the drug for when death occurred. And I wouldn't say the non-lethal effects are to be dismissed. If you ask me they're way up there for making sure something like that doesn't happen again. The system today (hopefully) is better than back then. And yes, personally I think it's a good thing when the approval process for drugs assumes that "every new molecule should be treated as if it were a prion".

[fastaguy88]

It is perhaps worth mentioning that our ability to detect compounds that are mutagenic or teratogenic, or are likely to cause developmental abnormalities, has improved dramatically in the past 60 years, as has the stringency of drug testing. I'm not an expert, but I can certainly imagine that some of the animal testing that goes on today before a drug is approved is designed to identify problems in offspring. (The problem with thalidomide was not that its problems could not have been identified even 60 years ago; the problem was that the testing was not done or was suppressed.)

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.

[tharkun__]

No idea how I missed this for three days, I'm sorry.

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

(side note, not to start a flame war on that, but this is a prime example of what happens thanks to regulation but not market forces) While a lot has improved in that regard through regulation, one thing that sticks out is how similar some of this is to how things are still happening in much more recent times:

    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

Purdue pharma and Oxycontin come to mind. I wasn't even aware of this one until I just tried to find something else I vaguely remembered for you via a quick Google: https://www.reuters.com/investigates/special-report/usa-cour...

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. 

Harder, sure. I'm not a doctor, pharmacologist or anything like that. But I doubt that somehow doctors, pharmacologists, chemists et al are somehow immune to making assumptions. Test the hell out of this stuff. Check the "impossible" things and sometimes you will find that the "impossible" really just wasn't impossible, we just didn't think of something or didn't know about it yet. It's why general regression testing in an area can very easily find bugs. "But that's impossible, how's that related?" Well, I also can't tell you, it doesn't make immediate sense to me either but you will surely find out once you start debugging this and figure out how you broke that other downstream system, two steps removed from your change.

[fastaguy88]

The OP suggested that one-off drugs rarely had long-term side effects. Thalidomide was raised as a counter example (an expectant mother might take it only once). Oxycontin is not a counter-example; the long term side effects (as opposed to short-term overdose) require dosing over an extended period.

[jdavis703]

If I’m reading this correctly, Thalidomide caused damage to fetal tissue, but didn’t actually kill the parent? This is still an awful burden for the parent, but there’s lots of drugs that are known to cause tissue damage during pregnancy. I believe this is why pregnant people are often excluded from clinical trials.

[tharkun__]

Yes, it didn't kill the parent. You might have missed the part where it killed 40% of the children at or shortly after birth.

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.

[wussboy]

I think the ask was actually for an approved drug, taken briefly, that caused a delayed death in the person who was taking it. If we’re going to count prenatal effects, we can come up with thousands of examples. This is why pregnant women are always studied separately.

[tharkun__]

Let's take that apart:

    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.

Check. Contergan was approved and used in 46 countries. Notably in East Germany there are no known cases of this, because "thalidomide was rejected by the Central Committee of Experts for the Drug Traffic in the GDR, and was never approved for use."

    taken over a short-term (say less than a month)

Check. As quoted before, taking Contergan past day 42 didn't harm the fetus and deformities seem to have started on day 21. Less than a month.

    cause long-term death

Check. Over the long term (>6 months) it caused death in 40% of the babies born.

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.

[bena]

So 6 out of how many other studies and drugs they've released without scandal?

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.

[ionwake]

I’m perplexed why you are defending a corporation after such an excellent reply from the above poster ( and I’ve taken the vax).

But l add the death rate according the administration is around 0.5% from the latest stats due to lack of testing.

[bena]

It's less defending Pfizer and questioning the poster's true motives.

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.

[mensetmanusman]

A diversity of people will have a diversity of risk registers, this is actually healthy for long term stability because mono cultures have associated risks.

[vixen99]

No it's about one third of drugs according to a Yale study and it took a median of 4.2 years after the drugs were approved for safety concerns to be apparent.