Mounjaro Weekly Rant: Big Pharma, Little Pharma, No Pharma

This is my weekly Mounjaro update, which chronicles my progress with the current vogue GLP-1/GIP-1 drug. Writing is therapeutic for me, and if it provides a modicum of useful information to my readers, I’m happy.

First, I want to comment on a hot topic. An Internet rumor is circulating about the possible end of compounded tirzepatide, the generic version of Mounjaro and Zepbound. After I blow enough wind about that rumor and its implications, I’ll get to my numbers. This will be a shorter overall rant than last week’s because we both deserve a break.

In Reddit We Trust

The hot, rapidly spreading Reddit rumor is that the USFDA is preparing to remove Mounjaro and Zepbound from the shortage list in October. This is causing great distress among those who rely on compounding pharmacies for a cheaper alternative than the branded drugs. The basis for the rumor is an FDA response to a citizen’s query, in which that regulatory organization unwittingly dropped a hint about the shortage’s end. The upshot is that if the FDA says, “no shortage”, compounding pharmacies will not be permitted to sell tirzepatide.

No doubt, Eli Lilly & Company, the manufacturer of Mounjaro and Zepbound (both of which are brand names for tirzepatide), will push the FDA to move their case along. Of course, aggrieved parties, namely, the compounding pharmacies, will file lawsuits. Likely, Eli Lilly, a huge multinational corporation with deep pockets and massive lobbying influence, will prevail. Once the ball starts rolling, it is just a matter of time before the compounders are unable to sell tirzepatide. The headline will read, “Big Pharma to Little Pharma: Drop Dead!“

Compound Fractures

Two types of compounders, designated by their legal classification 503a and 503b, are affected. Right now, both sell uncompounded, generic tirzepatide, but after the drug comes off the shortage list, neither can legally do that.

In the case of 503a pharmacies, the good old-fashioned compounders, they still can accept legitimate prescriptions for compounded tirzepatide. Here, compounding means that the drug is mixed with Vitamin B12, for example, due to prescribed requirements for specific patients. However, they will need to stop selling uncompounded tirzepatide immediately.

A Hard Pill to Swallow

The 503b pharmacies, the ones that sell plain old tirzepatide, are typically mail-order pill mills. Some of them sprang up to sell boner pills after Pfizer created a market for them after the seminal introduction of Viagra (pun intended) and the fun drug subsequently went off patent. The FDA will allow a grace period during which 503b pharmacies can fulfill existing orders. I’m hearing that this can be for up to sixty days.

Presently, we are dealing with more speculation than fact. However, the shortage resolution will happen eventually if not in October, at which time the FDA will impose the restrictions. Certainly, Eli Lilly will push to hasten that outcome. It is their drug, they brought it to market at considerable expense for R&D, patentng, advertising, and production, so they want to protect what is theirs.

The parasitic compounders will suffer, as will those who opted to take the risk of using them. Ignorance of the enabling situation, namely, the necessarily temporary shortages of Mounjaro, Zepbound, Ozempic, and Wegovy, exacerbated by the marketing efforts of the compounders and their telehealth partners, lulled these patients into a false sense of security. What to do when the compounding channel goes away?

Will Widespread Panic Prevail?

I suspect that tirzepatide addicts using the compounded products will panic due to Internet-fed rumors about the supply shutdown. Some will exhort their doctors to prescribe compounded versions for which they might not have a specific need. However, Lilly has been getting nosy about such contrived scripts and I could see them using the courts to pressure doctors with the threat of losing their licenses.

Other tirzepatide junkies might order huge quantities of the precious drug. Either they will feed their own habits or, when the dawn of profitability realization breaks on their thick skulls, they might enter the resale market, which, of course, is illegal as hell.

Any way you slice it, there will be chaos in the tirzepatide market!

The Danger of Questionable Sources

Another big issue with people buying large quantities of these drugs from questionable suppliers is their unknown shelf-life. What is the danger of things going wrong as they age? Many are reconstituted, and who knows what the labs are using as preservatives?

Unlike with Lilly, the FDA does not exert tight quality control over these compounded products. From some compounding pharmacies, tirzepatide might be perfectly safe, but from others, patients might be taking their life in their hands, injecting tainted substances into their bodies. Remember the case of New England Compounding Pharmacy and the one hundred deaths associated with one of their injectable compounded products? The principals were jailed ex post facto, but too little, too late. People died.

How About Third-World Tirzepatide?

Another possibility is that desperate weight-loss addicts will seek out foreign sources for their substances. I saw an Australian Broadcasting Company programme about a compounding pill mill Down Under that was illegally selling semaglutide (sister drug to tirzepatide) into the U.S. They interviewed some of the Americans who were bilked by the pill mill. They told horror stories about the unusable products they received.

So, I can foresee all kinds of problems arising in the future stemming from people’s outsize desire to lose weight. They’ll flail around blaming Eli Lilly for being greedy, but they’ll either be dealing with Lilly’s prices or with their black-market suppliers.

While the long-term outlook for the pill mills might be uncertain, I bet they will experience a significant bump in sales in the short term. Addicts will be addicts, and addicts must get their fix.

The big question in my mind is: How stupid will desperate people be regarding where and how they get their drugs?

My Progress on Mounjaro

Now, let’s move on to my progress on Mounjaro.

My glucose average for the week, as reported by my Dexcom Stelo, was 107 mg/dL. This is an improvement, and it equates to an A1c of 5.4. We’re homing in on my target of 5.2! My weight increased 1.6 pounds since last Monday, which is no cause for concern in the aftermath of my rapid, COVID-influenced weight loss (ten pounds in a week).

Blood pressure has been an issue since the COVID episode. Back on the 100 mg dose of Losartan, my average was 135/80. Before my vacation, I had been averaging 119/70 after reducing the Losartan to 50 mg. I believe my blood pressure will improve when I can resume a decent exercise regimen, which I suspended due to COVID and back/hip issues. Along those lines, before I close this week’s all-about-me Mounjaro progress journal, I’ll take a side-trip to da hip.

Back and Hip Issues, You Say?

During my vacation, I tweaked my back, and wound up with sciatica-like symptoms, which continue now, close to a month later. My doctor, who opts for conservative treatments first, told me to try Alleve for two weeks. I did, and it didn’t help. I still have thigh pain and numbness. So, I have put in a request for him to order an MRI so we can see what is going on in there. Without the diagnostic imagery, I am flying blind. I have no idea whether I am dealing with a disc issue, a nerve issue, or a hip degeneration issue. I had my left hip replaced in 2001; now, could the right hip be shot, too?

With hopes of confirming that or eliminating it as a possibility, I attempted to make an appointment with Dr. Kahuna, my knee guy, who is also a hip replacement surgeon. In fact, he trained under the surgeon who replaced my left hip. However, without imaging to support the notion that a hip replacement might be necessary, the policy of the orthopedic clinic is to use a physician extender to evaluate the condition before bothering the big kahuna with a case that might not require his expert surgical intervention. So, I made an appointment with an unknown physician assistant named Laura.

Aesthetically Speaking

I did some background checking on Laura. Turns out that she either runs or ran an “aesthetic” clinic. You know what that is? Botox and lip inflation for rich matrons. Her reviews for that clinic were terrific, but what in the bloody hell does vaginal reconstruction have to do with evaluating my hip? This revelation further underscored the need for me to get the damn MRI. While I originally thought it might be fun to have the conversation with Laura to get her story, who the hell has the time for such entertainment?

If the MRI says I need a hip replacement, I can skip the extender evaluation and go straight to Dr. Kahuna. Once I receive the order from Dr. DeLorean, I’ll cancel the vaginal rejuvenation evaluation. If the MRI results point elsewhere, I’ll deal with that. Flying blind sucks!

Wrapping It Up and Putting a Bow on It.

That’s it for this week. In the coming weeks, we’ll no doubt learn more about the travails of the Little Pharma vs. Big Pharma. And I hope to be back next week with some new tidbits associated with my Mounjaro therapy and my general state of being.

Until then…