Not too long ago, I wrote a post discussing the various categories of regulatory oversight for veterinary medicines. These range from pretty good evidence of safety and efficacy for approved drugs to no meaningful requirement for scientific evidence (and usually pretty little of it) for supplements and herbal remedies.
While I have focused a lot in the past on the weakest evidentiary category, unapproved supplements and remedies, I also regularly point out the problems with the others. In particular, I have repeatedly tried to get vets and pet owners to understand that even medications with a plausible, science-based rationale can turn out to be less effective, and less safe, than we hope if used without high-quality research evaluating them for the same problem and the same species we are trying to treat. Most of the examples in my latest lecture on practices we should consider abandoning involve such treatments.
I recently ran across a particularly egregious example of this in my own current field of canine aging and longevity science. Several vets (e.g. Petspan, Dr. Toman) are actively advertising their wiliness to prescribe the drug rapamycin to dogs and cats for the purposes of extending lifespan. This would count as an off-label use of a drug approved for humans but not for dogs and cats. This means that there is absolutely no clinical trial evidence showing this drug extends lifespan in these species. Even more problematic, that is not what the drug is approved for in humans, and there are no clinical studies showing it makes us live longer either! So this is definitely a practice based entirely on extrapolation from basic science and research in species and circumstances radically different from those of our pets.
Rapamycin is probably the most publicly well-known of the potential longevity medicines currently being studies. There is a solid physiologic rationale for why it might extend healthspan and lifespan, involving effects on cellular and molecular pathways known to significantly impact longevity. There is positive evidence of lifespan extension in animal models (e.g. fruit flies and mice), and some evidence from human studies of positive effects that might reduce age-related disease and extend lifespan (though no actual evidence yet exists showing increased longevity in humans attributable to this drug).
There is even some research on rapamycin in dogs and cats. One study in dogs found no significant objective effects, positive or negative, of low-dose rapamycin, though subjectively owners saw changes they perceived as positive more often in dogs on the drug than in those on a placebo. Another group ran a similar trial study which found no negative effects and no positive likely to be clinically meaningful, and a longer clinical trial is under way. Similar small studies have been done in cats, and one showed promising results for delaying the progression of a specific type of heart muscle disease.
Such research is a key step in the process of moving from basic biology to a clinically safe and effective therapy. However, while there is lots of excitement about the potential of rapamycin to extend healthspan and lifespan, and this is based on plausible and encouraging science, it is far too early to be prescribing this drug with lifespan claims. The vast majority of drugs which look promising in early research turn out to have less efficacy or more risks than first hoped once they are tested in larger, more diverse populations. While I think there is some reason for optimism about the potential benefits of rapamycin, I think it is not responsible to prescribe it and not ethical to make longevity claims about it in dogs based on the existing data. If we were talking about a medication that might treat an aggressively painful or fatal condition, acting on the basis of limited and early evidence might be justified. When we are talking about slowing aging and extending lifespan, which is effectively preventive medicine for health dogs, the bar for safety and efficacy should be much higher, and rapamycin has not yet cleared it.
I also suspect that such prescriptions are not legal, based on the rules for extra-label use of prescription medication in veterinary patients. These required-
- A valid ongoing veterinarian-client-patient relationship (VCPR). While some states are getting more flexible in their tolerance of virtual VCPRs, I think an online relationship with a vet for the sole purpose of prescribing an off-label drug to extend lifespan is pushing the limits and violating the spirit, if not the letter, of the law.
- “FDA’s requirements for extra-label drug use in animals limits this use to situations where an animal’s health is threatened or where the animal may suffer or die without treatment.” While it can be argued that aging is the #1 cause of suffering and death in the long run, this is clearly not how the rules were written or intended. When the risks and benefits of a drug are as uncertain as they currently are for long-term use of rapamycin in healthy dogs, these can only be offset by an urgent need for treatment based on current suffering and imminent death or disability, which is not the case with normal aging.
It is unlikely that the FDA will take action against this practice given their limited resources and the political climate, which seems to discourage enforcement of such rules intended to protect veterinary patients. Therefore, it is up to consumers and veterinarians to be both informed and mindful of the scientific uncertainty and the ethical concerns such practices entail.
rapamycin nnt nnh cost and caregiver burden please
Answer
Number Needed to Treat (NNT) and Number Needed to Harm (NNH) for Rapamycin:
NNT for Rapamycin: The Number Needed to Treat (NNT) for rapamycin in the context of longevity or healthspan extension has not been explicitly detailed in the provided search results. However, general discussions around NNT involve calculating how many individuals would need to be treated for one to benefit, which in clinical settings might relate to outcomes like preventing cancer or improving healthspan. For rapamycin, used off-label for anti-aging, this would depend on the specific outcome measure (e.g., prevention of age-related diseases, extension of healthspan).
NNH for Rapamycin: Similarly, the Number Needed to Harm (NNH) isn’t directly provided for rapamycin’s off-label use, but it’s crucial for understanding the safety profile. Rapamycin, being an immunosuppressant, has known side effects like increased susceptibility to infections, metabolic disruptions, etc. The NNH would reflect how many patients would experience a harmful event for one additional patient to be affected negatively by rapamycin.
Cost Considerations:
Generic and Compounded Rapamycin: The cost can vary significantly depending on whether it’s generic or compounded. For instance, in some regions, generic rapamycin might be more accessible and cheaper than compounded versions, which might be more expensive due to customization for off-label use. Costs can range, but specifics weren’t detailed in the provided information.
Prescription and Monitoring: The cost of rapamycin treatment isn’t just the drug itself but includes:
Initial consultation fees with a specialist or anti-aging clinic (like Healthspan).
Regular monitoring which might include blood work to check for side effects or efficacy, potentially adding to the overall cost.
Caregiver Burden:
For Aging-Related Care: If rapamycin were effective in extending healthspan or preventing age-related diseases, it could potentially reduce caregiver burden by:
Delaying or preventing the onset of conditions requiring intensive caregiving, like Alzheimer’s or severe cardiovascular diseases.
However, the burden might shift to ensuring compliance with the medication regimen and monitoring for side effects, which could involve regular medical check-ups, managing potential adverse effects, or even administering the drug if necessary.
Potential Side Effects Management: Caregivers might need to be vigilant about side effects like infections or metabolic changes, which could increase their responsibilities in managing health and possibly coordinating additional healthcare services.
Summary:
NNT and NNH: These metrics for rapamycin in longevity contexts aren’t well-established in clinical practice due to its off-label use. More research would be needed for precise numbers.
Cost: While the drug itself might be affordable in generic form, the overall treatment plan including consultations, monitoring, and potential side effect management could increase costs.
Caregiver Burden: Potentially reduced by delaying severe age-related diseases, but increased due to the need for careful monitoring and management of the treatment protocol.
Please note, the effectiveness, safety, and economic aspects of rapamycin for longevity are still under investigation, and its use for these purposes is not FDA-approved, hence it’s considered experimental with inherent risks and uncertainties.
rapamycin is sold with a human and a dog label. Is the cost of rapamycin higher for the human label or dog labeled rapamycin?
Answer
The cost of rapamycin for human use tends to be higher than for dog use due to several factors:
Dosage and Formulation: For humans, rapamycin might come in different formulations, dosages, or under brand names like Rapamune, which can increase the price. The cost for a human prescription, especially when sold under brand names, can be significantly higher due to the costs associated with drug development, clinical trials, and marketing.
Market Dynamics: The pharmaceutical market for human medications is influenced by factors like insurance coverage, copay systems, and pharmacy benefit managers, which can inflate the price. For instance, human medications might be priced higher due to the expectation of insurance reimbursement.
Research and Approval: Drugs approved for human use undergo extensive clinical trials for safety and efficacy, which adds to the cost. While rapamycin is not specifically approved for longevity or anti-aging in humans, its use in other medical conditions still involves these costs. For dogs, while there have been studies, the approval and market dynamics might differ, potentially leading to a lower price point for veterinary use, especially if it’s used off-label or in generic forms.
Generic Availability: If rapamycin for dogs is more often available in a generic form, this could lead to lower costs compared to the human version, which might still be under patent or trademark for certain uses.
From the information available, human-labeled rapamycin like Rapamune can cost upwards of $1000 for a month’s supply, whereas for dogs, the cost can be significantly less, often between $60 to $100 for a month’s supply at dosages used in studies like the Dog Aging Project.
Therefore, generally, you would expect the cost of rapamycin to be higher for human labels than for dog labels, considering the typical market conditions and the specifics of pharmaceutical pricing. However, prices can vary widely based on location, pharmacy, discounts, and whether one is buying generic or brand-name versions.
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the fda is now allowing rapamycin for pets to advertise a 20% increase in life expectancy for pets on Facebook ads. I guess you can say anything on Facebook as long as you pay to advertise it and the FDA does not object.