A dog is closely followed by pharma companies after a bad reaction to a new mast cell treatment

Complaint: Complaint 21-138
Respondent: Betsy Hershey
Premises: Integrative Veterinary Oncology

The complainant says that Virbac/QBiotics introduced Stelfonta, an injection for mast cell tumors in dogs, to the US and is currently only available to veterinary oncologists (there's a lot to unpack in that statement alone as far as what's happening to veterinary care). She says that the drug is known to have serious side effects and not without risks, thereby requiring serious monitoring and aftercare protocols; she alleges that Hershey even mentioned this. We are also told that steroids should be given to prevent degranulation (the mast cells break down as they die and release nasty stuff that dogs don't do well with). The complainant says Hershey treated the dog using Stelfonta after checking for metastatic activity; she claims that Hershey inaccurately prescribed 2.5 milligrams of prednisone twice a day after giving the injection. She was told to expect some swelling and bruising as well as edema that would progress down the leg. The dog instead allegedly suffered a blackened thigh all the way down his leg, swelling, degloving revealing tendon and muscle, bruising and edema in his abdomen, penis, scrotum, and rectal area that made it impossible to even check the dog's temperature. She contacted the manufacturer who told her such a reaction would not occur in a correctly managed dog. She discovered during one of the follow-up visits that the discharge papers were recommending 5 mg twice a day instead of the 2.5 mg twice a day that was on her other paperwork and prescription. The complainant apparently included a photo of her dog under Hershey's care with Stelfonta that wasn't included in the public records request.

Hershey says that she determined the dog qualified for treatment with Stelfonta. She also recommended staging the dog with x-rays and ultrasound as well as a biopsy because the tumor may have metastasized; this would make the dog not a good candidate. She says that the complainant asked for a refill on prednisone and as the dog had not yet been committed to Stelfonta therapy she refilled the drug at the dose prescribed by the primary veterinarian. She also says she recommended that the complainant visit Stelfonta's website and look at some photos to educate herself on what the treatment would be like. She admits that at the time she had only used the treatment on two other dogs but points out it was a very new treatment; since this case she's treated two more dogs for a total of five. She also admits that she thought the dog was being given 5 milligrams of prednisone at the time treatments started but now realizes that was incorrect. Hershey then goes into detail of the dog's post-treatment events, including contacts with Frank Hurtig from Virbac and Pam Jones from QBiotic; she says that she was told that this appeared to be just another degranulation event as they see in dogs treated with their new drug and it's nothing to write home about. We're also told that Virbac offered to cover the costs of physical therapy for the dog and that Hurtig and Jones are in constant contact with Hershey regarding the dog's recovery. Hershey herself offered to help take care of the dog each day at no cost to the complainant but never heard back.

The Investigative Committee said that it was an "honest mistake" with "no malice" that was caught and corrected; they also found that Hershey offered to help out for free which makes it even better. We're also told that we don't even know if the steroids would have kept the adverse reaction from happening, so why worry? They had some concern that Hershey didn't check the prednisone dosage with the complainant but didn't think it was really that big of a deal in the end.

We were able to reach the complainant and learn more about events subsequent to the complaint. The interviewee indicated that while Virbac/QBiotics initially indicated that the reaction was likely the result of Hershey's oversight regarding steroid dosages, once they began talking with the veterinary clinic the story changed: the steroid dose could not be responsible and continued follow-up should be done with the same veterinarian.

The dog's degranulation event also allegedly prevented giving the second shot in the sequence, preventing the mast cell tumor from being treated further. It appears that the dog lived with the mast cell tumor for some time. According to the interviewee, the dog subsequently suffered from valley fever and was treated by a different veterinarian; medications provided for the valley fever allegedly exacerbated the mast cell tumor, leading to a subsequent prescription for steroids that appears to have precipitated the dog's death from congestive heart failure.

Motions

Investigative Motion: Dismiss with no violation

Source: October 10, 2021 PM Investigative Committee Meeting
People:
Betsy Hershey Respondent
David Stoll Respondent Attorney
Roll Call:
Adam Almaraz Aye
Amrit Rai Aye
Brian Sidaway Aye
Gregg Maura Aye
Steven Dow Aye
Result: Passed

Board Motion: Dismiss with no violation

Source: November 11, 2021 Board Meeting
People:
David Stoll Respondent Attorney
Proposed By: Robyn Jaynes
Seconded By: Jessica Creager
Roll Call:
Craig Nausley Aye
Darren Wright Aye
J Greg Byrne Aye
Jane Soloman Absent
Jessica Creager Aye
Jim Loughead Aye
Nikki Frost Absent
Robyn Jaynes Aye
Result: Passed

The primary source for the above summary was obtained as a public record from the Arizona State Veterinary Medical Examining Board. You are welcome to review the original records and board meeting minutes by clicking the relevant links. While we endeavor to provide an accurate summary of the complaint, response, investigative reports and board actions, we encourage you to review the primary sources and come to your own conclusions. In some cases we have also been able to reach out to individuals with knowledge of specific complaints, and where possible that information will be included here.