FDA – Pain In The Bud

Oh Oh Oh Ozempic For Our Oh Oh Oh Obese Cats? It’s Close To Reality

In apocalyptic news for house cats everywhere, a pharmaceutical company is kicking off a trial of a GLP-1 drug for felines.

If cats could read newspapers, chances are they’d be gripped by a cold terror right about now, wondering if they’re among the unfortunates to have their yums curtailed by the same weight loss drugs their humans have been gobbling.

As the New York Times reports, a biopharma company headquartered in San Francisco, Okava Pharmaceuticals, is about to begin a trial to determine if GLP-1 drugs can help our chonksters slim down. More than 60 percent of American pets are packing extra pounds, the Times notes, while consequences like diabetes are shortening the lifespans and reducing quality of life for felines and canines.

“It is our belief that the condition of obesity, the condition of being overweight, is by far the number one most significant preventative health challenge in all of veterinary medicine,” Okava founder and CEO Michael Klotsman told the paper.

The upcoming study will include 50 cats. Most will receive a GPL-1 medication while a control group — about one third of the cats — will be given a placebo.

Since cats aren’t exactly known for being cooperative when it comes to taking oral medicine and weekly injections at a veterinary office are impractical, Okava has developed a system with a patch about the size of a microchip that will dispense the weight loss drugs over six months before a tiny cartridge needs to be replaced.

If all goes well with the trial, Okava will seek FDA approval and address other obstacles like convincing caretakers that their little pals can benefit from the feline version of Ozempic, Mounjaro and Wegovy.

That may be easier said than done considering our relationships with our furry friends and the role food plays in things like training, bonding and every day life

For lots of cat caretakers “their main way that they interact with and show their love to their pet often revolves around food,” Dr. Maryanne Murphy, a veterinary nutritionist at the University of Tennessee, told the Times.

How could the dynamic between cat and human change if the flow of yums is reduced to meals only? Will training — for everything from walking on a harness, to entering a carrier and fun tricks like high fives — still work if the reward is just a bit of encouragement or a scratch behind the ear?

An earlier weight loss drug developed for dogs, Slentrol, did not catch on because, as one veterinarian noted, “the main way [people] interacted with their pet was by feeding them, and seeing their excitement and happiness when they were eating the food.”

There’s also the not-so-small matter of cost. GLP-1 drugs are in high demand, and they’re expensive. One in eight Americans has taken Ozempic or one of its competitors. At times, the demand has threatened availability for diabetics, for whom the drugs were developed in the first place.

If the trials are successful and the GLP-1 drugs for pets gain FDA approval — which would require a series of much larger scale, more rigorous studies — the company hopes to offer them to consumers at a cost of about $100 per month per pet.

Even if this iteration of the drug fails, it’s unlikely to derail the larger effort. Vets have been prescribing tiny doses of the human version to cats with diabetes, and perhaps most telling of all, pet obesity continues to rise despite years of efforts by the veterinarian community to get people to play with their pets more and feed them less.

As Dr. Ernie Ward, a veterarian and founder of the Association for Pet Obesity Prevention, told the paper: “We haven’t moved the needle.”

And now we check in with our correspondent, Buddy the Cat. Buddy, what do you think about the possibility of GLP-1 for your species and the end of the proverbial gravy train?

Buddy? Bud? Are we having technical difficulties?

I’m sorry, ladies and gentlemen, we can’t find Buddy the Cat. We’ll resume this segment if and when we manage to locate him.

For The First Time, American Vets Can Prescribe FIP Meds For Cats

People whose cats are infected with FIP can now get a legal prescription and buy it from a US pharmacy. A full course of treatment will cost a few hundred dollars instead of the thousands charged on the illegal market.

Starting on June 1, people whose cats are infected with deadly Feline Infectious Peritonitis won’t have to shell out thousands of dollars to shady middlemen importing the cure from China.

FIP is a virtual death sentence for cats, but there’s a drug — GS-441524 — that has a cure rate somewhere around 90 percent, a Godsend for people whose beloved felines are afflicted with the virus.

Previously the only way to get it was through predatory online middlemen who charged exorbitant sums, but thanks to a partnership between UK pharmaceutical company Bova Group and New Jersey-based compounding pharmacy Stokes, the FIP cure will be available legally in the US.

The legal version of the drug will come in a tuna-flavored tablet format and customers can expect to pay a few hundred dollars for a full treatment instead of between $5,000 and $15,000 some paid for the FIP treatment from importers.

A US company invented the drug and held the rights, so it seemed like bringing it to market for cat caretakers would be a no-brainer. Unfortunately, GS-441524 is similar to COVID drug Remdesivir so the company was worried if they submitted the FIP cure to the FDA for approval and the FDA did not grant it, the denial could lead the agency to revoke its approval of Remdesivir due to its molecular similarity.

As a result, innumerable people whose cats were suffering with FIP turned to groups like Facebook’s FIP Warriors to help them obtain GS-441524 illegally. The drug was manufactured by facilities in China, sold to middlemen in the US and Europe, then marked up by eye-watering amounts for sale to people with sick cats.

jupiterpitbtopimg — Jupiter, a British shorthair, was diagnosed with FIP. His human, a young professional from London, paid almost $10,000 for FIP treatment obtained through middlemen.

Last year the feds announced they’d exposed a GS-441524 smuggling ring, alleging a woman from Texas and another from Oregon had made almost $10 million from selling the FIP treatment to panicked cat lovers.

GS-441524 importers knew their customers were desperate to save their beloved feline friends so they’d be willing to pay the extraordinary mark-up — and pay they did.

Here at PITB we’ve interviewed and written about several people whose cats were diagnosed with FIP. One of them, a student, spent her entire savings on GS-441524 obtained through the Facebook group and relied on help from generous donors to raise the rest. Another, a young professional in London, paid even more, spending £7,500 (about $9,400 at the time) on the medication alone, not including vet visits.

A Texas woman whose cat, Seth, was diagnosed with FIP said the middlemen — and women — said the sellers “saw our desperate situation and took advantage of us.”

“It was a very stressful time for us, and every time we needed to refill, they charged us more,” she told PITB. “They knew we couldn’t say no.”

For readers interested in more details about GS-441524, Stokes pharmacy has a resource page that breaks down pricing, shipment times, availability and more.

Parsnip, the cat pictured at the top, and Jupiter, the British shorthair pictured within the story, were both cured after taking full courses of GS-441524.

‘Every Time We Needed To Refill, They Charged Us More’: FDA Says 2 US Women Made Millions Off Desperate People Whose Cats Had FIPV

The importers are accused of jacking up prices almost 16 fold on FIPV drugs they illegally imported from China, the FDA says.

FIPV is pretty much a guaranteed death sentence for cats, and the only way to cure it is with an experimental drug that doesn’t have FDA approval.

Oregon’s Nancy Ross and Nicole Randall of Texas knew that, and as importers selling the cure via the popular Facebook group FIP Warriors, the FDA says they banked on the desperation of people who would do almost anything to save their cats — including forking over vast sums of money.

Ross and Randall are now accused by the FDA of smuggling GS-441524 from China, where it’s manufactured illegally, and hiking the price by almost 16 times what they paid for it as they served as the middle women between desperate cat owners and the suppliers in Hong Kong.

Feline infectious peritonitis kills some 95 percent of cats it infects, and veterinarians often tell their clients with FIPV cats that while they can’t prescribe GS-441524, they will help administer it, track their cats’ progress through bloodwork and hopefully save feline lives — if the clients obtain the drug themselves.

FIP Warriors — now in its fifth incarnation as FIP Warriors 5.0 on Facebook — is where people with FIPV cats go to find suppliers. The group has more than 43,000 members, and the FDA says Randall made millions off of them, charging as much as $385 for vials of GS-441524 she obtained for between $25 and $45 from manufacturers in Hong Kong and mainland China.

Randall sold $9.6 million worth of GS-441524 to clients in the US, according to the FDA. Per The Oregonian:

“A spreadsheet found in Randall’s Google email showed customer orders of at least 58,460 vials and 236,836 pills of GS-441524 from July 2020 through June 6, 2022, the affidavit said.”

PITB spoke to several people who paid thousands of dollars for GS-441524 after their cats were diagnosed with FIPV. All of them said they were surprised by the news of the FDA’s investigation, and said they were given various reasons for why the drug was so expensive to acquire.

One customer from Texas, whose cat Seth began his regimen in July of 2020, told PITB she doesn’t regret spending the money to cure Seth, but she “can see how the people saw our desperate situation and took advantage of us.” She was told prices were at a premium because of scarcity.

“It was a very stressful time for us, and every time we needed to refill, they charged us more,” she said. “They knew we couldn’t say no.”

Another woman, whose kitten was diagnosed with FIPV in 2021, “was told that the prices were set because they ensure the medication was purchased from a trusted source.”

As a college student at the time, she used her savings and crowdfunded the other half, paying more than $5,000 for her kitten’s treatment. She said she doesn’t think the administrators of the group were ripping her off, since they had FIP cats of their own, and likely didn’t know the importers were making huge profits. She trusted the seller — who was not Ross or Randall — because the group vouched for that person, assuring her they supplied real pills.

“Of course, I don’t think this is a valid justification for hiking up prices up to 16x the amount,” she told PITB, “but I’m sincerely hoping the individual [accused by the FDA] had a valid reason for setting the prices that she did.”

Others paid even more exorbitant prices: a British woman we interviewed for a story about FIPV in 2022 said she paid about £7,000, or $9,400 at the time.

FDA investigators said they intercepted shipments from China and Hong Kong disguised as COVID masks, cat shampoo and chewable medicine for pets, and the Oregonian report says the shipments were listed as “essential oils” and “beauty products” in import documents.

Randall and Ross have not been charged criminally, but they are now targets of a civil asset forfeiture case:

“The government seized five of Randall’s bank and brokerage accounts and her 2022 Tesla Model Y car last year based on a warrant signed by a federal magistrate judge in Oregon.

The warrant identified the bank accounts and car as proceeds from the “crime of smuggling” and subject to forfeiture, according to the affidavit. It also alleged Randall, now 35, used the proceeds to buy several properties, including a ranch in Leander, Texas, in July 2021.”

While the FDA’s affidavit went into detail regarding Randall’s earnings, it describes shipments sent to Ross but does not specify how much she may have made in profit. An attorney for Randall told The Oregonian that the Texas woman will fight the civil asset forfeiture.

The illegal market for GS-441524 exists because the drug’s creator, Gilead Sciences of California, declined to submit it to the FDA for approval. That’s because it’s chemically similar to another drug the company makes, remdesivir, which was floated as a possible treatment for COVID-19. The company was worried any snags in a potential approval process for GS-441524 would also ensnare remdesivir, according to reports, putting the latter drug in limbo during the pandemic.

Now that the pandemic has retreated to much lower levels of infection and death, it’s not clear if Gilead Sciences will reconsider its FIPV medication, but there may be hope in the form of alternate treatments. A report from the American Animal Hospital Association (AAHA) says scientists at the University of California-Davis and UC San Diego are working on several promising therapies, including a potential treatment using CRISPR gene-editing technology.

But until another cure or treatment passes trials and earns FDA approval — a process that could take years — people with FIPV-diagnosed cats remain at the mercy of strangers on the internet, spending thousands of dollars per regimen and hoping the drugs they buy are the real deal.

Sunday Cats: FDA Approves Kitty Arthritis Drug, Woman Calls Cops On Her Cat, Grudge Gets A Book

The new med could be a “game changer” for kitty quality of life. Meanwhile, Grudge the Cat of Star Trek fame gets her own origin story comic.

Older cats could soon have easier lives after the FDA approved the first-ever drug to treat feline arthritis.

Degenerative joint disease and the pain that comes with it is extremely common, impacting 45 percent of all domestic cats and 90 percent of cats older than 10.

It’s the reason kitties “slow down” later in life, it’s a significant blow to quality of life and it often leads to decisions to euthanize beloved pets who are in severe pain. The new drug, called Solensia, has been described as a “highly efficacious treatment” by experts. It can “extend [cat] life, extend their happiness, and extend that beautiful relationship between cats and their owners,” Dr. Duncan Lascelles told USA Today.

“This is absolutely groundbreaking,” said Lascelles, who researches pain and surgical methods at the North Carolina State College of Veterinary Medicine. “I have been in pain research for 30 years and this is the most exciting development that has happened.”

Solensia is administered via injection by veterinarians, with doses calculated by weight. Because traditional painkillers and other drugs can aggravate kidney disease and other common feline ailments, the new medication “marks the first treatment option to help provide relief to cats that are suffering from this condition,” said Dr. Steven Solomon, director of the FDA’s Center for Veterinary Medicine.

“You’re Grounded, Go To Your Room!”

A Nebraska woman called the police on her cat this past Monday, Jan. 10, after kitty supposedly flipped out.

The woman told police she was breaking up a fight between her cats when she warned one of the feline aggressors she would “put it in its room” if the fighting didn’t stop.

“At this point, the cat became enraged and attacked,” the police report says.

The woman suffered “superficial” scratches from the cat’s claws and was treated at a local clinic as a preventative measure. Unfortunately Omaha police took the cat and brought it to the Nebraska Humane Society. It’s not clear if the cat was permanently removed from its home or what its fate will be. Calls to the police and the Humane Society by Newsweek were not immediately returned.

Grudge The Cat Gets Her Own Comic

I’m not a big fan of Discovery, the newest iteration of Star Trek, but there are some elements of the show I like — including Grudge, the feisty Maine Coon companion of the rogueish Cleveland Booker, played by David Ajala.

Now Grudge stars in first issue of a new spinoff comic, dubbed Adventures in the 32nd Century.” The comic will tell Grudge’s origin story, as well as how she encountered Booker and appointed him her loyal human servant.

Although Grudge is female and often referred to as Queen Grudge in the show, she’s played by a pair of Maine Coon brothers, Leeu and Durban, who swap off between acting in front of the camera and napping.

If you can’t get enough of the well-traveled kitty, there’s also The Book of Grudge, in which the Star Trek feline shares her opinion on everything from space travel to the nature of time.

“Depending on what planet you’re on, what sun you’re passing or what temporal anomaly you find yourself in, I’ve learned that time is nothing but an artificial construct,” Grudge muses in the book. “So it’s in everyone’s best interests to synchronize their clocks to me.”

Buddy’s Solution To National Cat Food Shortage

Dear Friends,

It has come to my attention that our human servants are experiencing unprecedented difficulty in locating and purchasing canned cat food, commonly known as yums, due to Coronavirus-related warehouse and logistical challenges.

The companies that make yums have had facilities intermittently closed due to COVID breakouts, leading to shortages which have been compounded by the logistical problems as delivery systems are already overwhelmed.

There can be only one solution to this most serious of problems: Humans must share their food!

Effective immediately, I call on all humans to share their yums with us, and no skimping!

If you’re having filet mignon for dinner, Fluffy better get some too. I would also urge every one of you to increase your turkey consumption, setting aside generous portions for your feline overlords.

Not only is turkey delicious, but it increases the body’s immune response to viruses like COVID-19, according to the Buddy Center for Scientific Research. (This statement has not been evaluated by the FDA.)

Do the right thing, humans. Share your food!

Your friend,
Buddy the Cat