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The Myth of Drug Expiration Dates

propublica.org

81–90 of 275 posts

Re: The Myth of Drug Expiration Dates

#81
post #56

Earlier quoted context omitted.

And to add into that, dosage studies are rarely adequately done for most drugs. The dose we take is often a best guess and may be twice or more than we need, so 10% is even more inconsequential.

This is completely wrong. Dosage studies happens between Phase 2 and Phase 3 trials (and Phase 4 "post marketing" too) and are the most expensive, longest and most scientific process that arguably any business engages in in the entire world. Phase 1 is a safety test in healthy ~men. These seek to find the maximum dose before adverse effects appear in the healthiest humans. Phase 2 is a safety/dosage test in a much la…

Sounds like you don't know what you are talking about. Your source is a book written with heavy influence by the Pharmaceutical industry to justify the obscene costs of their drugs, making billions in profits off of sick, poor people.

You are the one who is completely wrong.

The dosages most certainly do start out with a "best guess" in the pre-clinical phase. For any given drug we would guess at the doses based on our calculations, and give a range on either end. If we thought the effective dose would be 1 mg/kg, we would run an LD50 of doses much higher than that, 10mg/kg, 100mg/kg. Sometimes our guesses would be wrong, and the low dose animals would die as a result. After figuring out a safe dose, we would then split it further into different dosing groups to test the effectiveness of the compound. Most people in the field are underpaid, overworked, and do sloppy work

Please talk to someone who has actually worked in the Pharma research field, they will tell you most of what they do is just guessing.. why do you think only 1 in 10,000 make it through?

It's all a guess until the end, and even then we're often not sure. Look at anti-depressants. We still don't know how a lot of those work but prescribe them to millions of people regardless. How do you think they determined the dose when they don't know how the drug works?

Re: The Myth of Drug Expiration Dates

#82
post #21

In Denver there is a program that supplies hospitals internationally with expired drugs and equipment that would otherwise be without. It's been going on for decades and saved many lives.

I'd think there's a business opportunity in recycling the still-active chemicals in those pills.

Re: The Myth of Drug Expiration Dates

#83
Degraded tetracycline has been documented to be dangerous in those who are suffering from renal failure.

There's also the possibility that a person may be suffering from a new undiagnosed condition, which hadn't yet onset when they were initially prescribed the drug. In this case you could think of it less as an expiration for the drug, and more of a suggestion to seek additional medical guidance on continuing after a certain date.

There's also the remote possibility that a new drug is developed which could potentially become dangerous when expired. The general population would have to unlearn little morsels of knowledge such as this, in the meantime people could be harmed.

Edge cases like this are enough in my opinion to warrant not spreading blanket advice like this, even if it's nearly always true. Erring on the side of caution is the best approach with medical affairs, even if it costs a bit extra monetarily. Giving patients potentially dangerous advice so they can save money is ethically questionable at best.

Re: The Myth of Drug Expiration Dates

#84
post #77

(former pharmaceutical developer here). This article makes it sound like there's a big conspiracy, which there isn't. A very few drugs (like erythromycin) become toxic so should be discarded. Some drugs become less efficacious over time, but nobody really knows the shape of the curve as they are simply tested to see if they have the same efficacy on day E as they did on day 0. Well of course all drugs will become wor…

> Last week purchased some vacuum-packed lamb that had a manufacturer label with an expiration date a month away, but was prominently labeled to expire this week.

Are you sure this was an expiration dates, and not a "sell by" or "best before" date?

A sell-by date is the date at which the grocery store will voluntarily throw out the product—not because it has gone bad, but rather because its unprepared appearance/texture will have changed enough that people will either avoid the product on the shelf, or will complain and return the product, even though those differences disappear once the product is prepared. I'm talking here about things like "bruised" bananas, "slimy" baby carrots, raw chicken that's turned a slightly deeper shade of pink, and anything that "smells off" when taken out of the package. The grocery store can't make a profit keeping these products on the shelf past a certain point—even though they're perfectly fine and safe to eat—so it does some Business Intelligence stuff to optimize the profit-curve given (shelf-space opportunity-cost + complaint PR-cost + return-cost), and out comes a number they print on the label for when they should remove the thing to replace it with a newer one if they want to make the most money.

You might think that this makes for a lot of waste. But grocery stores are aware of this waste, and how it translates directly to lost profit opportunities, so they're usually on the hunt for ways to solve this. This is why so many groceries have in-store delis that make ready-to-eat meals: it's a way to turn products people aren't willing to buy, into products they are, by doing the preparation step themselves.

Often, also, grocery conglomerates have "up-market" and "down-market" marques they operate under. Down-market customer bases have higher tolerance for these "red-herring signs of spoilage" (probably because they've at some point tried these foods out of necessity and found out they were fine after all), so the conglomerate can take advantage of this when building a centralized logistics pipeline for its stores: when it acquires produce/dairy/meat/etc., the stuff that already has some of these signs (or will likely acquire them sooner) is sent to the down-market-branded stores, while the up-market-branded stores get the products that appear fresher and will continue to appear fresh for longer. This is a necessity—if they didn't do this, they wouldn't be able to keep the up-market stores in stock given said stores' customers' intolerance for signs of spoilage—but it conveniently allows the up-market store brand a cachet of having "the freshest" produce, allowing them to justify charging more for food from the same farms.

And, finally, some grocery chains have deals with e.g. homeless shelters, to provide them these voluntarily-expired products as ingredients for free-meals programs. Grocery stores get people to feel good with "can drives" for food banks, donating non-perishables, but perishables are in much greater demand, and it's often the stores themselves that are doing the most good there. (Why don't they talk this up for PR? Because the fact that this is "expired" food would have to come up, and the public will never bother to read and understand what I just wrote above.)

Re: The Myth of Drug Expiration Dates

#85
post #66

This issue is a conundrum. Most drugs don't fall off a cliff of efficacy when they reach their expiration date. There are drugs such as tetracyclines that should never be used past their expiration dates because they degrade into toxic compounds. Certain classes of drugs such as anti-arrhythmics or drugs like warfarin are dosing critical to the point where I would not want them if they were out of date. I worked in p…

The other issue (as mentioned in the article) is environment. For example I keep some drugs in a backpack that I regularly leave in a hot car. The drugs that were in the Pharmacy probably had near ideal conditions and didn't even move. Giving end users and consumers an algorithm to follow with regard to disposal simply would stand little chance of working in a practical sense. One size fits all is the way to go.

Re: The Myth of Drug Expiration Dates

#86

This article has some shoddy logic. For the vast majority of drugs, the actual marginal manufacturing price per pill is essentially zero. That means that when the expired pills are thrown away and new pills are manufactured, there is no true economic loss. Rather, all that potentially happens is a transfer between the consumer and the manufacturer. If pill prices were set by some external force, this could at least b…

>This article has some shoddy logic... all that potentially happens is a transfer between the consumer and the manufacturer.

The point of the article is that this is an expensive mess for everyone except the manufacturer, which means approximately everyone. As a consumer, having the manufacturer "transfer" money from your pocket into their own sucks. Seems like the article's logic is actually pretty decent.

Also, even if we accept that the marginal cost of producing a pill is near-zero, that's ignoring the entire rest of the supply chain. It's not like drugs are magically teleported. There are real costs in time, money, and resources for creating the packaging, transporting drugs, stocking/shelving them, unstocking them, sending them to a disposal location, and then disposing of them. All of that is a complete loss. Most of it generates various forms of pollution, waste, and other externalities. This also sucks for ~everyone.

Basically, outside of theoretical econ-land, wasting perfectly good things is wasteful.

Re: The Myth of Drug Expiration Dates

#87
post #66

This issue is a conundrum. Most drugs don't fall off a cliff of efficacy when they reach their expiration date. There are drugs such as tetracyclines that should never be used past their expiration dates because they degrade into toxic compounds. Certain classes of drugs such as anti-arrhythmics or drugs like warfarin are dosing critical to the point where I would not want them if they were out of date. I worked in p…

I wonder if a single rule 'no consumption past date' is a safeguard to insure simple behavior from population. If people started to think some drugs can and some cant they might indulge into trying random stuff.

I agree keeping the message simple is important, but isn't the implication of the article that the FDA's requirements need more nuance? Some medicines could have expiration dates of 10 years, others should be kept to 2?

Re: The Myth of Drug Expiration Dates

#88

> The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations. What kind of reporting is this? Anything less than 100% is not "as potent as when manufactured", and the sentence implies some of those dozen weren't close to 100%. > The idea that drugs expire on specified dates goes back at…

> That seems to be the problem. There was a procedure in place to set expiration dates scientifically, and it was ignored for some reason, limiting the legal shelf life of even the most stable compounds to a few years.

To investigate how a drug breaks down over a ten-year timespan, you'd need to do at least one ten-year study of the drug. That seems difficult to justify.

Re: The Myth of Drug Expiration Dates

#89
post #73

Earlier quoted context omitted.

I wonder if a single rule 'no consumption past date' is a safeguard to insure simple behavior from population. If people started to think some drugs can and some cant they might indulge into trying random stuff.

yes, that's a big part of it. It's a simple rule that's easy to follow, which can often be better in terms of health overall.

Yeah unless we put something better in place, maybe a dedicated QR code website to quickly verify if that box is 1, 2, 10, toxic

Re: The Myth of Drug Expiration Dates

#90

Earlier quoted context omitted.

I wonder if a single rule 'no consumption past date' is a safeguard to insure simple behavior from population. If people started to think some drugs can and some cant they might indulge into trying random stuff.

I agree keeping the message simple is important, but isn't the implication of the article that the FDA's requirements need more nuance? Some medicines could have expiration dates of 10 years, others should be kept to 2?

Yeah unless we put something better in place, maybe a dedicated QR code website to quickly verify if that box is 1, 2, 10, toxic
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