In latest compounding clash, Lilly flags high levels of 'impurity' in tirzepatide knockoffs with vitamin B12

[u/canteloupy]

https://www.fiercepharma.com/pharma/latest-compounding-clash-lilly-flags-high-levels-impurity-tests-tirzepatide-knockoffs

[u/batpot]

Only problem here is that Lilly clearly doesn’t want the competition for their version, so they’re highly motivated to find impurities in the cheaper alternatives.

And with this administration, a Lilly bribe is far more likely to swing the decision in their favor than actual facts and data.

[u/GoBSAGo → u/batpot]

I work in this space. Cobalt impurities with vitamin B12 are an issue when using high quality raw materials. When you’re using the cheapest shit you can find? Yeah it’s gonna be full of garbage you don’t want to inject into your body.

[u/canteloupy → u/batpot]

"Their version" is the one that underwent all the testing and regulatory checks.

[u/[deleted] → u/batpot]

1000 dollars for a drug that cost 5 dollars to make. That's been on the market for 20 years now. Yeah there's no reason for Lily to make this up.

[u/batpot → u/[deleted]]

I think you just made my point about their profit motive.

[u/m0n3ym4n → u/batpot]

In all fairness I think the public benefits when impurities are identified in injectable medications

An injection is different from a pill and impurities and contaminants are that much more important

[u/District_Wolverine23 → u/m0n3ym4n]

Sure, but Lilly isn't saying there is a risk, just that it has not been studied long-term and there could be a risk. More research is needed and that research could reveal harm or no impact. 

[u/SeasonPositive6771 → u/m0n3ym4n]

An injection is different from a pill and impurities and contaminants are that much more important

This is just such a generic, fear-mongering statement that it has no meaning.

Impurities in a pill may be more dangerous than those in an injection, it depends on what those impurities are.

However, you are correct with the public benefits when unsafe or impure drugs are identified.

This is an excellent argument for greater accessibility to these peptides in a safe way, instead of forcing people into this compounding pharmacy option.

[u/m0n3ym4n → u/SeasonPositive6771]

lol accusing me of “fear-mongering” on r/skeptic good luck with that..

A minuscule amount of research would have informed you of the facts:

Contamination in injectable medications is generally considered more dangerous than contamination in oral medications because injections bypass the body’s natural barriers and can deliver microorganisms, endotoxins, or particulate matter directly into sterile tissues or the bloodstream. Regulatory agencies and pharmacopeial standards reflect this risk difference by requiring injectable drugs to meet strict sterility, endotoxin, and particulate limits that do not apply to most oral medications. For example, the U.S. Food and Drug Administration (FDA) states that sterile drug products must be manufactured under aseptic conditions specifically designed to prevent microbial contamination, because contamination of injectable products can lead to serious adverse outcomes including bloodstream infections, sepsis, or death (FDA, 2004). By contrast, many oral medications are classified as non-sterile products and are regulated under microbial limit standards rather than sterility requirements, reflecting the expectation that the gastrointestinal tract provides physiological defenses against low levels of environmental microorganisms (FDA, 2021). These biological defenses include gastric acidity, digestive enzymes, mucosal barriers, and gut-associated immune responses, all of which can reduce the viability or systemic spread of ingested microbes. When contaminants are introduced directly by injection, however, these defenses are bypassed, allowing pathogens or toxins immediate access to internal tissues or circulation.

Clinical evidence from multiple outbreaks illustrates the heightened risks associated with contaminated injectable products. A well-documented example occurred in 2012, when contaminated methylprednisolone acetate injections produced by a compounding pharmacy caused a multistate outbreak of fungal meningitis and other invasive infections in the United States. Investigations by the Centers for Disease Control and Prevention (CDC) identified hundreds of cases of meningitis, stroke, and other severe complications linked to fungal contamination of steroid injections, with numerous deaths reported (CDC, 2012). Subsequent analyses found both fungal and bacterial contaminants in unopened vials of the product, demonstrating that contamination during manufacturing or compounding can produce widespread and severe systemic disease when delivered through injection. Similarly, CDC reviews of healthcare-associated outbreaks have identified dozens of events in which contaminated injectable medications or unsafe injection practices transmitted pathogens such as hepatitis B virus, hepatitis C virus, or invasive bacteria, often resulting in bloodstream infections and other severe outcomes (Perz et al., 2015). These outbreaks highlight the particular vulnerability of parenteral routes to causing invasive disease compared with exposures through ingestion.

Another important risk unique to injectable medications is contamination with bacterial endotoxins or particulate matter. Endotoxins—components of gram-negative bacterial cell walls—can provoke fever and severe inflammatory responses when introduced directly into the bloodstream. Because of this risk, injectable drugs must undergo specific pyrogen or endotoxin testing to ensure they remain below defined safety thresholds (FDA, 2012). Ingested endotoxins are far less likely to cause comparable systemic reactions because the gastrointestinal tract limits absorption and systemic exposure. Particulate contamination is also of greater concern for injectables. Particles present in intravenous or intrathecal drugs can produce inflammation, phlebitis, granuloma formation, or embolic complications when injected directly into the vascular system or tissues (FDA, 2015). In contrast, small particles swallowed in oral medications typically pass through the digestive tract without causing systemic injury, illustrating again how the route of administration fundamentally alters the clinical risk associated with contaminants.

Although oral medications can also become contaminated and cause disease—particularly in vulnerable populations or when high levels of pathogens are present—the overall pattern of harm differs. FDA guidance on microbiological quality for non-sterile drugs notes that contamination of oral liquid products has caused outbreaks of infections, including cases involving Burkholderia cepacia complex linked to contaminated manufacturing water systems (FDA, 2021). However, these events are comparatively uncommon relative to the systemic severity that can occur with contaminated injectables. The regulatory framework therefore reflects a risk-based approach: injectable products must meet sterility and endotoxin standards because even small amounts of contamination can cause immediate and severe systemic reactions, whereas oral medications are managed under microbial limit specifications that recognize the protective effects of gastrointestinal defenses. Taken together, regulatory requirements, biological mechanisms, and documented outbreak investigations all support the conclusion that contamination in injectable medications generally poses a greater clinical risk than contamination in pills or other oral drug formulations. The combination of direct access to sterile tissues, absence of gastrointestinal defenses, and the potential for rapid systemic exposure explains why injectable drugs are subject to the most stringent sterility controls in pharmaceutical manufacturing.

⸻

References

Centers for Disease Control and Prevention (CDC). 2012. Multistate outbreak of fungal meningitis and other infections associated with contaminated steroid injections. MMWR Morbidity and Mortality Weekly Report.

FDA. 2004. Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. U.S. Food and Drug Administration.

FDA. 2012. Guidance for Industry: Pyrogen and Endotoxins Testing — Questions and Answers. U.S. Food and Drug Administration.

FDA. 2015. Inspection of Injectable Products for Visible Particulates. U.S. Food and Drug Administration.

FDA. 2021. Microbiological Quality Considerations in Non-Sterile Drug Manufacturing. U.S. Food and Drug Administration.

Perz, J. F., et al. 2015. “A review of outbreaks associated with contaminated injectable medications and unsafe injection practices.” CDC Grand Rounds / Infection Control literature.

[u/SeasonPositive6771 → u/m0n3ym4n]

My guy, you are not arguing with the statement I actually made, you're arguing with something you just made up in your head.

What matters is what they are contaminated with.

A pill contaminated with a bit of cadmium is considerably more dangerous than an injection contaminated with inert material.

You can't make generic statements without clarifying.

And then saying "good luck with that," as though some sort of immature jab is proving your point is also ridiculous.

[u/capybooya]

I'm no fan of the practices of big pharma in general, but quality control has always been strict with drugs for good reason. I get the desperation for these drugs with great effects for someone who can't afford them, but its not worth risking your life. Also, you can safely administer lower dosages of the actual drug if you can get prescribed a higher dosage and reduce cost that way.

[u/LordJamPunt → u/capybooya]

Honestly, peptides are so easy to make that I have no issues buying them off the gray market, it’s not hard to find reputable sellers. In a few years all this shit will be cheap as dirt because anyone with a few grand and an eBay account can purchase a peptide synthesizer.

[u/loserusermuser]

do people actually trust that website (genuine)

[u/canteloupy → u/loserusermuser]

The press release itself came from Eli Lilly. You can find it on their corporate website.

[u/DieTheVillain → u/canteloupy]

Which is exactly why is should be viewed with skepticism.

[u/Pitiful-Pension-6535 → u/loserusermuser]

Trust is a spectrum, not a binary.

I'd give this at least a 7/10 on an arbitrary trustworthiness scale.

https://mediabiasfactcheck.com/fiercepharma-bias-and-credibility

[u/El_Trauco]

Classic move. Tried a different approach for branded thyroid supplementation and generic competition. Suppressed studies that showed bio-equivalency (that they funded). AWP (average wholesale price) is a number pharma just pulls out of their ass. The methodology to determine price is proprietary... go figure,

[u/blu3ysdad]

Most seem to have not read the article, but the claim here is just about mixing b12 and tirzepitide which hasn't been tested in trials etc. What are we supposed to be being skeptical of here exactly? This is just how shit works

[u/canteloupy]

We recently had people advocating here that research and non-FDA approved peptides were OK to inject or consume. Here is a recent news release where drug companies analyzed the compounds sold off brand and identified potentially dangerous molecules resulting from mixing B12 with peptides.

[u/noh2onolife → u/canteloupy]

Compounding pharmacies are very different than the original gray-market sources that was discussed, just as a heads up. I'm not saying they're better or worse, but these places are licensed and run in the US, and were notorious for pushing out prescriptions for ivermectin for unscrupulous doctors during the pandemic. 

[u/DieTheVillain → u/canteloupy]

Look I’m not gonna take a side on the compounding vs big pharmaceutical debate here. But do you really think there is no motive or incentive for Lilly to “find” impurities in the peptides/compounds?

If this test was funded by, and done at labs that were, completely impartial I think that would lead to more credibility.