Zantac’s maker kept quiet about cancer risks for 40 years
fiercepharma.com
fiercepharma.com
> GSK's leadership was warned on several occasions about the storage issue, but it opted against making any changes to existing plans.
In a way, this makes it worse, because they could have taken action to limit the risk to people, but chose not to, presumably to save money or to avoid bad publicity.
How old your ranitidine would have to be to have too-high NDMA level without higher heat, I haven't seen any specifics around that.
I imagine they could have instead instituted limits about temperature of storage and transport, and chop down the expiration dates, and add big warnings for consumers to actually respect the dates, not keep them in cars, etc... though the market reality that there are several other H2 blockers out there that haven't been shown to have the NDMA issue, not to mention PPIs, likely meant that just pulling ranitidine was the better call.
I have so many major health problems that quite frankly I'll probably be dead before I could get cancer from this stuff.
Nothing else on the market compares.
The few batches we've bought have been legit (Ranimax 150, product of India), but QA with these sorts of vendors isn't exactly guaranteed (for all I know, your first purchase would be reconstituted sawdust and rat droppings). I'm not comfortable giving standing referrals to any fly-by-night operation.
I just mentioned it as a possibility because for those with bad-enough GERD, there are no retail options, and the assumption is that the product has been recalled worldwide. Not so!
It’s not over-the-counter where I live, but the adult (tablet) version is.
It's paywalled, but this seems to be referenced by a lot of reports:
https://www.bloomberg.com/news/articles/2020-01-02/carcinoge...
Maybe someone else has the actual source.
And the linked article says:
> Valisure discovered the link of Zantac and its generics to the carcinogen NDMA during its routine testing of every batch of every medication, and first notified the FDA of its initial findings in June of 2019. On September 13th, Valisure filed a detailed petition with the Food and Drug Administration asking the agency to recall all products containing ranitidine.
How in the world is it profitable for an online pharmacy to do this? It's great, but honestly who would pay extra to an online pharmacy to do this testing? Would most people even believe an online pharmacy that said that they did such testing? I'd love to know how they survive.
This means that they have to do some inbound quality control to ensure that what they believe they are selling really is what they are selling.
Note that ValisureRx (consumer pharmacy that dispensed lot-tested drugs) was sold to Medley Pharmacy, which just folded. Valisure is now just a testing lab.
Finally, it's not just a chain of custody thing. Even big generic brands and name-brands source a huge amount of active pharmaceutical ingredients (APIs) from China and India.
https://digitalhealth.modernhealthcare.com/finance/medly-sel...
I suspect it's not that they go out of their way to do extra testing, it's that they don't necessarily trust suppliers but willing to eat the cost of testing + risk of bad inputs because they still net ahead compared to more reputable but expensive suppliers.
As of 2021, it appears they pivoted to running the lab as a service for other companies. I found one online pharmacy that was using Valisure (Medly.com) but it appears to have gone bankrupt, assets acquired by Walgreens and shut down.
https://www.businessinsider.com/walgreens-buys-medly-pharmac...
That was almost two years ago. This is the first I'm hearing about this. So for all I know, I was exposed to an unknown amount of carcinogen for years without being told anything about it even after that information was discovered.
What's my recourse?
A lawsuit, like the thousands mentioned in the article.
There's nothing unique or novel about this situation. Is it surprisingly that it happened or just surprising that it happened to you? This is what we do son, this is what american is for. This is the system working as intended.
In reality, the absolute harm done to me (if any) is probably very limited. Maybe my lifelong risk of cancer has gone up by some quite small amount. The greater harm is damage to my trust in the organizations that produce my necessary medications.
So the recourse is probably not giving me anything extravagant, it's probably more about some sort of fix to oversight, regulation, corporate penalties paid for this, etc. None of which is likely to happen as a result of a lawsuit, except maaaybe the last one.
These are the same class of chemicals that are found in cured meat and they are present in an awful lot of food because they are produced during fermentation. Bacon, beer, even a side product of drinking water treatment.
Its hot enough to chemically alter things, activate diffusions, speed bacterial growth, etc.
Its not hot enough to sterilize what you're ingesting.
(sadly before the era of camera phones, but the needle crystals really did look neat. The contents of the bottle were not ingested.)
Coke delivery guys make sure to rotate the diet soda when they deliver it (my wife took a day-in-the-life tour when she was at coke)
This sounds bad, but it's worth keeping in mind that plain tomato juice has something like 6x methanol in it than diet sodas. The quantities involved are tiny. Aspartame is metabolized in the same way when consumed cold. The big reason soda manufacturers are concerned about heat is that it loses its sweetness.
(all that being said, it's probably still a good idea to avoid anyway)
Thoughts:
- You really need a cigarette lighter mini fridge. They're less than $100 at home depot. Note, they suck, but you don't have alternatives and you'll be able to have a cold beer occasionally.
Careful not to drain the car battery, and keep it in a shaded part of your vehicle.
- I find that there can large T differences in the car. Under the seat is fairly cool, and the T is more stable.
Keep your meds and the mini-fridge there, preferably by the floor vent if equipped.
- Does your van have windows or is it a workman's van? Glass is your enemy. You probably cant afford to just buy a van, but a white windowless Transit van is better than a Pacifica.
- Use white bed sheets to cover your interior and shade everything.
- you probably do this, but solar windshield covers.
- Keep your windows open a crack. Really just a crack small enough to keep even the rain out. Convection is huge. This is most important at day if crime is locally a problem.
- Paint it white.
- If you can, take advantage of the van's mobility and move to fairer weather throughout the year. If you have to stay in the LA region, go north just across the mesa (?) towards S. Barbara. Much cooler there. Id set myself up in Montecito myself.
Its not ideal but even just keeping them in a small drink ice chest in a shaded/insulated area and keeping the van ventilated will help keep temps down.
A professional semi-chemist sounds much more interesting.
Interestingly, all the Southern grannies knew this: they distrusted ice and made their tea with a pinch of baking soda, although this does change the flavor a bit.
Luckily I don't like sweet tea or other full sugar drinks (you can pry diet coke from my dead hands). Hadn't heard about the ice thing though.
My biggest triggers are fatty foods, tomato, chocolate, and palm oil.
https://www.chemistryworld.com/news/judge-dismisses-ranitidi...
If they could find a way to ensure the impurity didn’t exist, I would certainly buy ranitidine again. I found it was the most effective antacid for me.
Further, one judge is not an arbiter of whether science is sound or not. In fact, the American legal system is infamous for its persistent reliance on fraudulent forensic techniques even well after there's widespread consensus that they're unreliable if not outright fraudulent.
Polygraphs, writing analysis, fiber analysis, hair analysis, fingerprint analysis, drug-sniffing dogs...all have long been found to be far less reliable than courts treat them to be.
The latter is probably the most egregious example, with the Supreme Court agreeing that such dogs are actually worse than a coin flip in terms of correctly indicating a "hit" on drugs...and then shrugged and said dogs were still a valid legal basis for further, more invasive searching.
1: "Anticholinergic Accumulation: A Slumbering Interaction between Drugs and Food Supplements" https://onlinelibrary.wiley.com/doi/full/10.1111/bcpt.12437
2: Chart of medicines with high ACB scores (higher is worse) - you will recognize some of these, such as allergy and anti-nausea meds: (pdf warning) https://corumpharmacy.com/wp-content/uploads/2020/08/Anticho...
Everything will kill you, no need to get worked up about the infinitesimal risk.
https://www.bmj.com/content/321/7260/572.1
17% vs 77%
Pepcid (famotidine) and Tagamet (Cimetidine) are H2 blockers, another class of heartburn medication, that hasn't shown the same issues.
On the other hand, untreated chronic reflux is a big driver for stomach and esophageal cancers. So it's possible that having taken Zantac for a long time was less risky cancer-wise than not taking anything.
The real problem is that they get a slap on the wrist from the regulator and the business continues as usual.
Remember: GSK didn't make an unethical decision, people did. Letting those people hide behind a corporation means that workers and shareholders pay the consequences for decisions that were only made by a few people.
Oh wait. Maybe they would. everything gives you cancer now, doesn't it?
Yes, but only in California
Exposure to some things can cause more mutations or hinder your body's error-correction systems, sometimes to extreme degrees. It is a numbers game, though.
https://corporateeurope.org/en/2021/05/big-pharmas-lobbying-...
I wouldn't hold my breath that any other country will prosecute either.
[PDF warning]
it also has the wholesale prices on there.
Putting this on GSK means that the people who knowingly sold a cancer-causing drug while hiding the risks get away without any consequences. Given this went on for 40 years, probably a lot of those people are retired, and won't even lose pay, bonuses, share price, etc.
Meanwhile, assuming this leads to any sort of lawsuits, fines, and lost sales, the people who will pay the price if GSK is held responsible will be shareholders, who likely had no visibility into these decisions, and workers who will be laid off, again without having had any role in these decisions.
This system is fundamentally broken. It's not just a small loophole that can be closed: the entire thing is a loophole that allows sociopaths to exit with the profits of wrongdoing while workers and shareholders pay the consequences. We need to stop letting bad people hide behind corporations.
Name the people responsible, and hold them responsible.
In theory shareholders have the power to prevent this sort of thing, but they don't have the visibility into the daily goings on at a company to see when things like this happen.
Likewise, the vast majority of workers had nothing to do with this decision.
In a more general sense, I do think it's healthy to let companies fail rather than subsidizing non-working business models. But as a means of disincentivizing bad behavior, it's totally ineffective.
A large sample size means less if the problems are longer-term in nature such as an increase in cancer rates down the road or problems with fertility, which might take more time to fully detect and understand.
And a large sample size means little without a control group: yet if some people had their way, there'd be no control group left.
Look at the COX-2 inhibitors as well. They were on the market for almost a decade before the increased risk of heart attack popped up in the data.
If you on principle refuse to take any medication or vaccine due to the fact that they almost all have rare, unstudied or potential side effects then that's totally fair. The human body is a very complex thing and every single one of us is different so it's basically impossible to truly know if a drug will have no rare side effects for some sub group. Or at least do extensive deep research on every single medication you take including supplements and over the counter things.
If you only do this for the covid vaccine due to reading too much fearmongering then that just means you're irrational.
Every pill of ranitidine would undergo this process in storage, if I understand correctly. Yet it took 40 years for it to finally be confirmed.
Even worse, I have taken ranitidine that I had in storage (not in heat) for more than a year! So this news is all the more alarming.
Of course, catching covid may also have unknown long term side effects, like how some who caught Spanish flu went on to develop encephalitis lethargica.
Vaccinated or not you're part of what is effectively the largest post marketing clinical study, either as the treatment or control group. Science is fun like that.
Also each company is independent.
All you're doing is saying that bad things happened instead of comparing it to the number of non bad things.
If we had this much money and this many eyes on studying and testing Zantac, I have no doubt they wouldn't have been able to keep the cancer risks secret.
Which can all be found after 30 seconds of Googling or simply by paying attention to all the news these got over the last few years.
The myocarditis is caused by the same spike proteins that are in the virus itself, and the relative risk of myocarditis from an actual Covid infection versus the vaccine is many times higher.
Which can all be found after 30 seconds of Googling or simply by paying attention to all the news these got over the last few years.
>The same complications exist in far higher rates with COVID itself.
Is that relevant if most people who get the jab also later get covid?
You do realize that the whole point of a vaccine is to either prevent or improve the symptoms of a disease right? So if you're nearly guaranteed to get covid then you definitely want to suffer a smaller number of complications from a vaccine and then reduced post-vaccine covid complications versus the much worse complications of un-vaccinated covid. The math is different if you're unlikely to catch covid but as you admit yourself that isn't the case nowadays.
This is so false. Took literally one Google search to find a study about "why" and the relationship to myocarditis and Covid 19: https://www.heart.org/en/news/2022/08/22/covid-19-infection-...
Viral infections are one of the top causes for myocarditis. https://www.mayoclinic.org/diseases-conditions/myocarditis/s...
Vaccines work by stimulating one's immune system response in ways similar to infection, they are literally designed to trigger the same immuno response in a safe way to prevent severe illness from future exposure. https://en.wikipedia.org/wiki/Vaccine
> Vaccines work by stimulating one's immune system response in ways similar to infection
Wrong. This is not how the MRNA vaccine works. The only thing that the MRNA vaccines produce is the spike protein, and it's bound with an additional part so that even the spike protein can't be active. It doesn't deliver the same immune response as it does from a COVID 19 infection at all.
All of which doesn't answer the question why are 12-17 year olds suffering a 1 in 5000 chance of getting myocarditis from the vaccine?
https://clinicaltrials.gov/ct2/show/results/NCT04405076
It’s pretty impressive how weird antivaxxers have convinced millions of people to not take vaccines based on their ignorance of the subject but here we are.
Both fit "no one knows why" - and that's the problem with such statements.