This week, one of the biggest scandals in the history of PANS/PANDAS Advocacy is afoot: an effort to re-classify PANDAS/PANS as a rare disease—behind closed doors, without a consortium of researchers, without clear scientific evidence, and as usual, without consulting patients.
Narrowing the definition of PANS would mean thousands of patients could lose treatment possibilities, and thousands more will become much, much less likely to even be diagnosed.
Reclassifying PANDAS/PANS as rare is a terrible idea that needs to be stopped.
If enough of you read this post, share it, and write to the PANDAS-related organizations to oppose defining PANS as “rare,” I think we can stop a looming disaster… But if you don’t, these people could undo two decades of advocacy.
The Background of the 2026 PANDAS/PANS Scandal
I received a tip from an anonymous source that some prominent figures in the PANS community––a couple of researchers and the head of a PANDAS/PANS advocacy organization––are vying to reclassify PANS as a rare disease with the USA’s HHS (Health and Human Services).
These supporters of reclassifying PANDAS/PANS as rare said it will help pharmaceutical companies save millions on their applications for FDA approval. They said this will be a win for patients. They said it will help people get insurance approval for IVIG. One person said that moving away from citing PANS as affecting 1 in 200 is based in evidence that shows it’s closer to 1 in 10,000.
But the reality is far darker and far more complex… and the community deserves to know this discussion is happening so they can speak out against it. Here are nine reasons why:
1) A Pharma company’s bottom line shouldn’t be the priority of the PANS community.
A rare disease designation would eliminate a $4.6 million fee for companies to seek FDA approval for their drugs. It would also effectively grant any approved product a seven-year monopoly over similar products for PANS treatment. For example, if one manufacturer has their IVIG product FDA-approved for PANS using the Rare Disease Program, other IVIG product manufacturers wouldn’t be able to seek FDA approval for PANS during that time.
Any company who gets a drug FDA-approved through the Orphan Drug program stands to make millions from multiple years of exclusivity. This fact alone deserves scrutiny and transparency that I don’t see the community currently being granted. We deserve to know who really stands to benefit from reclassifying PANS as rare, and how.
An open discussion with the whole advocacy community––and independent third-party researchers––is warranted before such a major shift.
While a certain small subset of PANS patients, and a Pharma company’s bottom line, would benefit from an FDA Orphan Drug approval and monopoly, it likely comes with higher costs to patients overall. A recent analysis of the FDA’s Orphan Drug Act program showed that orphan drugs cost patients on average $218,872 versus $12,798 for non-orphan drugs––a 17-fold cost difference. While families with good insurance plans won’t directly hurt from this, higher drug costs will disproportionately affect the under-insured and uninsured.
The analysis I cited didn’t look at immunoglobulins or other PANS-treatment agents exclusively. However, it demonstrates a precedent that, in many cases, drugs granted Orphan status don’t lower costs for patients. I also recommend any decision-makers read Congress.gov’s “The Orphan Drug Act: Legal Overview and Policy Considerations” for additional context.
2) If the incidence of PANS is redefined, anyone who doesn’t meet the very strict definition of PANS could have a more difficult time accessing treatment.
Part of the argument for helping companies get their FDA approval is under the guise of improving insurance coverage for patients. Indeed, it’s highly likely that a small subset of PANS patients would have an easier time getting insurance to cover their IVIG infusions with an Orphan Drug-designated product, potentially higher copays notwithstanding. However, this comes at the cost of far larger numbers of patients having a far more difficult time getting insurance approval.
Insurance companies would take the “rare disease” definition––and the strict criteria used in the new definition of PANS––to mean that only a very small number of people within that very narrowly defined subset have PANS at all. They will use every single reason to deny insurance coverage for treatments like IVIG to anyone and everyone else they can. This will be all the more true if you’re trying to get insurance to pay for drugs with no competition that cost tens of thousands of dollars per year.
To be clear, we’re likely talking about insurance issues for anyone who is not under age twelve with an acute-onset and very obvious, clear OCD… So, in other words, every single patient who doesn’t get a diagnosis and treatment before puberty would struggle even harder to get appropriate medical care. And even kids within the age range who don’t have an acute-onset of 24-48 hours would now struggle to access treatments.
If you believe that adults with PANS deserve access to diagnosis and treatment, you should be really, really pissed off right now. Proponents of the rare disease redefinition could end up undoing years of progress in recognizing that PANS isn’t always pediatric.
Moreover, IVIG products aren’t completely interchangeable in the way that non-biological drugs are. Some people may need a specific product, but then the Orphan Drug designation will mean only a different product is available to them. Cue some kids who do meet all the strict criteria also having trouble getting the alternative product they need.
But to be honest, so far these two arguments are still missing a fundamental point:
3) The prevalence studies cited as evidence are deeply flawed.
One of the so-called studies that claimed to show PANS affects only 1 in 11,000 involved looking at medical records of three academic center’s pediatric clinics retroactively. Specifically, they looked for diagnoses of psychiatric conditions. The study did not investigate neurologist or psychiatrist records, who are the most likely specialists to encounter PANS given its neuropsychiatric nature.
Pediatricians are not experts at diagnosing neurological or psychiatric conditions, meaning it’s highly likely they missed both psychiatric diagnoses and PANS cases.
Oh, and as usual… This study explicitly excluded adults as well as teenagers.
There is absolutely no scientific evidence to suggest something magical happens in a kid’s brain at age thirteen to make them no longer have PANS. So, it’s not hard to infer the age restriction of the study alone led to a significant number of missed cases. You can’t get an accurate prevalence estimate if you’re excluding cases.
The second study was based on a monthly form that asked pediatricians to report diagnoses of PANS. The study concluded it only affects 1 in 60,000. Looking at diagnosis rates by relying on doctors to retroactively fill out forms just shows they probably aren’t confident diagnosing PANS.
Neither of these studies should be considered robust enough to say that PANS should be classified as a rare disease.
4) Pretending there’s hard evidence that PANS is rare will damage the credibility of the entire community.
One of the biggest issues I’ve heard doctors object to with PANS is the fact that there aren’t more studies. It also doesn’t help that there are many unscrupulous providers out there peddling complete quackery that lacks any form of evidence and then calling themselves “PANS specialists.”
Think about what happens when a reputable PANS organization does a complete 180 and asserts something as fact that again lacks sufficient evidence––all in a move that helps Pharma’s profits. This only furthers the idea that PANS is something supported by vibes, magical thinking, and people looking to make a buck, rather than it being a condition backed by rigorous scientific research.
6) I highly doubt any PANS expert, patient, or family actually believes PANS is rare.
My knee-jerk reaction when I first read the tip was pure anger… and a feeling of betrayal. For years, the slogan of the community has been: “not rare, just rarely diagnosed.”
PANDAS Network said the exact same thing not so long ago:
Every one of us in the community can tell you we know another family or two (or more) in our local communities who is either currently dealing with or used to deal with PANS in one or more family members. My own doctors told me that after they educated themselves on PANS, they began noticing it and diagnosing it in other patients. My psychiatrist found at least a dozen others over the years, and my PCP and ENT surgeon diagnosed others as well.
So while we don’t have the studies yet, we absolutely have anecdotal evidence that PANS is very much NOT rare. And I have to suspect that every single person participating in the rare-disease classification discussion knows this. That’s why it feels like such a betrayal to see support for the bald-faced lie that PANS is for sure a rare disease.
7) Classifying PANS as rare will lead to large numbers of people not getting an appropriate diagnosis.
“PANDAS is rare” is what so many of us hear when being denied care as it is. In medicine, there’s a saying, “When you hear hoofbeats, think horses, not zebras.” In other words, doctors are trained to be biased towards the most common diagnoses.
If PANS is definitively reclassified as a rare disease by HHS, it will confirm ill-informed physicians’ opinions that they are unlikely to ever encounter it. What doctor will consider a PANS diagnosis that they’re told affects 1 in 10,000 when they know that “regular” Obsessive-Compulsive Disorder affects 1 in 100?
Indeed, even the harshest skeptics at this point concur that PANS probably exists, but with the caveat that it’s so rare they can’t expect to ever see it.
If PANDAS Advocacy organizations backtrack and agree with these skeptics, we will be playing straight into the hands of Gilbert, Singer, Mink,and all their ilk, who have already caused so much unnecessary suffering to our community with their denialism. It’s unacceptable that some in our community would have us effectively side with their skepticism after two decades of hard-won advocacy.
8) It’s premature to say we definitively know how rare PANS is.
It’s absolutely true that we don’t know exact numbers for how many people PANS affects. I agree with anyone who asserts this. The original 1 in 200 estimate was based on studies about pediatric OCD prevalence, but not studies specific to PANDAS or PANS.
Now, most researchers and clinicians who actually treat PANS day in and day out will tell you that 1 in 200 is likely an underestimate. But again, we don’t know a true number. As such, I think it’s best to refrain from giving any exact figures or making any specific claim about how rare PANS is.
If we can’t confidently assert that PANS affects 1 in 200, then we have no business citing any specific figure to the contrary, either. And we certainly have no excuse claiming that it’s a rare disease to a government agency.
9) Calling PANS rare undermines broader neuroimmune research.
I concur that a large number of people with immune- or infection-triggered neuropsychiatric symptoms don’t meet current diagnostic criteria for PANDAS or PANS. But that’s truly beside this final point.
The point is that the most up-to-date evidence shows that there are vast numbers of people suffering from many types of immune-mediated neuropsychiatric conditions: PANS, autoimmune encephalitis, neuropsychiatric Lupus, and others yet to be categorized. We are finding more and more evidence for immune system involvement in so-called “mental” illness.
We’re on the cusp of leaving the dark ages of dualistic medicine, in which brain illnesses are magically separated from any medical cause in the body. If you don’t believe me, spend a few minutes perusing Neuroimmune Foundation’s research library. You will see that, yes, there are still many more unknowns than knowns. But you will also see that there’s too much evidence stacking up that PANS as currently defined is likely just the beginning of a complete paradigm shift in psychiatry and neurology.
Those who advocate for shrinking the tent of the PANS community are thinking entirely too small.
If PANS is redefined as a rare phenomenon, what of the researchers who are looking at a much larger picture? What of the research aimed at searching for medical origins of conditions currently thought of as mental?
And if people are so concerned about Pharma companies’ profits… Imagine the possibilities if it’s proven that millions of people have an immune-mediated condition that would respond to immunotherapies. You’re talking about a vastly larger market than products directed at a 1 in 10,000 indication.
If PANS as a diagnostic entity is narrowed, then there is less hope of finding cures for people suffering from yet-to-be classified immune-mediated psychiatric symptoms.
If you’re going to support redefining PANS as a rare disease in 2026… You’re on the wrong side of science.
Patients deserve better than to be sold out for profit. Families deserve better. Clinicians trying to do right by their patients deserve better. Researchers conducting fair, patient-centric studies deserve better.
It’s time to collectively take a stand for evidence-based messaging and transparency within the PANS community.
Time is of the essence.
Please share this post widely within the PANS community.
Contact any advocacy groups with which you’re affiliated.
Tell organizations that classifying PANS as “rare” is NOT what the community needs.
About the author: The Dreaming Panda is the pseudonym of a 30-something PANS patient who has lived with the illness for two decades. Since 2014, they have blogged about their journey from diagnosis at age 19, through years of treatments, through remission and relapses, to their present truce with ongoing neuroimmune complications. TDP wants everyone to know they’re very tired of people still calling PANS a pediatric disease after twelve years of blogging and advocacy.
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