Calling for solidarity with men advanced prostate cancer who are experiencing risks from a meds shortage

Also, an update on my kidney stone surgery

It’s the time for “The Reluctant Brotherhood,” of prostate patients—low-risk to high-risk patients—to stand in solidarity wit those who are on the drug Pluvitco.

In case you missed it, the drug is in a short supply. Lives are at risk. Pressure needs to be applied on the U.S. Food and Drug Administration.

Please send the email below to:

Louis Marzella, MD, PhD  
Director, Division of Imaging and Radiation Medicine  
Center for Drug Evaluation and Research , FDA

Libero.Marzella@fda.hhs.gov

Laleh Amiri‐Kordesdani, M.D.  
Director, Division of Oncology 1  
Office of Oncologic Diseases, FDA

Laleh.Amirikordesdani@fda.hhs.gov

Valerie Jensen, R.Ph.  
Associate Director of Drug Shortages  
Center for Drug Evaluation and Research  
Food and Drug Administration

Valerie.Jensen@fda.hhs.gov  

Patrizia Cavazzoni, MD
Director, Center for Drug Evaluation & Research,
Food and Drug Administration

patrizia.cavazzoni@fda.hhs.gov

With a copy to: Rick Davis, of AnCan, rdavis@ancan.org, who is spearheading this campaign.

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Dear Drs. Marzella, Amiri‐Kordesdani, Cavazzoni & Ms. Jensen:  

This letter is in regard to the shortage of Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) Injection posted as “currently in shortage” by the FDA on March 7, 2023.  I would like to request an expedited review of Novartis’ facility located in Milburn, New Jersey to upgrade to commercial production of Pluvicto from its current research production.

If you are on the med write this: I am an advanced prostate cancer patient and well aware of the importance of Pluvicto in extending life for me and my peers. In my own case …….  (please add your own words here – patient stories are invaluable BUT keep it short!!!)

If you’re a supporter of our Fellows with advanced cancer, make note that.

There is urgent clinical need to expand production as men have and will die much sooner with access to Pluvicto impaired by production. The FDA is not alone in resolving this issue.  Patients also see significant responsibility lies with manufacturer Novartis, and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) that regulates radionuclide medicine.  Our patient organization, AnCan Foundation, has actively petitioned both to address:

• streamlining reallocation of doses to minimize wastage
• establishing medical criteria to advance patients with urgent need.  
We believe these two measures alone can go a long way to triage the shortage during and expedited FDA review. While Novartis and SNMMI are jointly considering these and other measures, no action has yet been taken by either and time is of the essence.

We urgently request that the FDA plays its part in addressing this crisis by expediting approval for the Milburn facility to upgrade from research to commercial production of Pluvicto.  Be assured that as patients, we will continue to lobby Novartis and SNMMI. Thank you for your consideration,

Yours sincerely,

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(DreamStudio AI of prostate gland à la Vincent van Gogh.)

This kidney stone gathering no moss

By Howard Wolinsky

My 4-millimeter kidney stone is gone. I am a kidney “stoner” no more—at least for the moment.

In a 30-minute procedure, my stone—inadvertently found in a CT scan about six months ago—was extracted. A brief laser blast cut it in half. Poof.

(If you don’t want to read the bloody, cringy clinical details, stop here.)

Urologist Grant Chavin used a wire basket to snatch, grab and remove the fragments.

I had done my best to try to wash it away with more water intake than usual for months to no avail. One side benefit, I am no longer dehydrated.

But this little bastard—near the maximum size that can pass in men; women can pass stones of up to 6 millimeters—had its own ideas. It was slightly pear-shaped and smooth—smooth would have favored a safe exit.

But this stone had a tiny hard stem that was embedded in the wall of the 10-12-inch ureter, the tune from the kidneys to the bladder.

(The walls of the ureter are lined with muscles that expand and contract to push. The ureter forms a short flattened channel within the bladder wall before entering the inside of the bladder.)

I was lucky that I didn’t have any serious symptoms. I only had occasional pain in my lower back, and some burning as the stone tried to leave.

I had three CTs that showed the stone didn’t move.

But the stone had the potential to shred the nerves and muscles in the ureter and, ultimately, lead to kidney loss.

Serious stuff. Again, I was lucky.

Chavin said the stone would never have left on its own. No matter how much water I drank.

Pain is usually ranked 1-10. But kidney stone pain hits a 12. Women I know say that kidney stone pain is worse than pain for childbirth.

After a first birth, women might start talking about having another baby.

Patients with kidney stones never plan for a second. If you have one stone, you have a 50% chance of future stones.

This was my second kidney stone since 2014.

I will be meeting with Dr. Chavin to get a strategy to prevent any more stones. We’re awaiting a pathology report.

I received great outpatient treatment at South Suburban Hospital in the southern Chicago burbs

(DreamStudio AI kidney stone removal by Vincent van Gogh.)

I had been a reluctant outpatient. I had been an in-patient there last fall for 48 hours from Hell and was less than enamored. But the Center for Advanced Care is newly remodeled and comfortable. Chavin encouraged me to give it a try.

(Shout out to all the staff, especially Brian, Nove, Melissa, Tolanda, Pat, Christian, Trey, et al. I was under the influence of anesthesia so I hope I remembered everyone and spelled their names correctly.)

The staffers were alert, reassuring, engaged, and pretended, at least, to laugh at my feeble attempts at humor.

I left them laughing. But I left the hospital in pain. I have been taking non-narcotic pain meds.

I don’t recall being warned me that I was at risk for incontinence. It’s like the Pythons’ Spanish Inquisition skits. Nobody expects them.

I write about incontinence in patients who have had prostatectomies. I have never been treated with surgery for prostate cancer and never have had incontinence.

Now I have a sense of what it is about at least following stone surgery.

I’ll be blunt. I owe you no less.

I am leaking bloody urine and have no control over my stream. I left bright red puddles in the hospital and now at home—brighter than Dr. Chavin’s curly red locks.

The hospital had no adult diapers. They gave me a disposable pair of underpants and had me put on a sanitary pad. Let’s be honest. It didn’t work great.

When I got home, we managed same-day delivery of Depends. It is helping a lot. I am leaving smaller messes. I am also improving already. Less fire in the urine and reduced red-hot pain. I feel for prostate cancer patients.

I received a stent to keep the ureter open. It also causes back pain from ureter spasms when I pee. The doctor is scheduled to remove the stent Monday morning.

In the end, I danced between the raindrops.

(DreamStudio AI of prostate gland per Salvador Dali.)