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Whether or not aging is clearly listed as a disease in the International Classification of Diseases (ICD) maintained by the World Health Organization (WHO) only matters because medical research and development is heavily regulated. Since aging isn’t classified as a disease, there is no clear roadmap to obtaining regulatory approval to treat aging with a working rejuvenation therapy, and therefore no investor is willing to commit to funding that work. What happens instead is that the range of biotech companies presently working to produce age-slowing and rejuvenating therapies pick a specific age-related disease to start with, and progress through the regulatory system on that basis. After approval, it will then become something of a political battle of wills between regulators and physicians as to whether widespread off-label use emerges.
So it may or may not make all that much difference at the end of the day as to whether or not the WHO incorporated a clear definition for aging into the ICD-11 as a clearly defined disease. It is probably not going to greatly change the enormous costs imposed on medical development and provision of medical services by the FDA and similar regulatory organizations. Nonetheless, there are factions within the research community that are agitating hard for one outcome or the other, and factions within the WHO that are clearly far more concerned about appearances and ageism than about progress towards therapies that can reduce suffering in old age. It is a circus and probably a waste of effort.
The only thing that will change the behavior of the ponderous, uncaring, regulatory giants is competition. That competition will have to arise in other countries, those more willing to allow therapies, with more reasonably regulatory burdens. Medical tourism is at present disorganized and a small concern in the bigger picture, but when every human over the age of 40 is a potential customer, rather than only the few who are severely ill at any given time, that may well start to change. The existence of effective therapies that are substantially cheaper and more readily available, even given the cost of travel, will put considerable pressure on the regulators who currently act as a roadblock to the mass adoption of these therapies. That hasn’t happened yet for senolytics, or fecal microbiota transplantation, or other possibilities, but I think that it will as evidence from clinical trials accumulates.
The debate over whether aging is a disease rages on
Last year, over Canadian Thanksgiving weekend, Kiran Rabheru eagerly joined a call with officials from the World Health Organization (WHO). Word had spread of a change coming to the WHO’s International Classification of Diseases (ICD), a catalogue used to standardize disease diagnosis worldwide. In an upcoming revision, the plan was to replace the diagnosis of “senility,” a term considered outdated, with something more expansive: “old age.” The new phrasing would be filed under a diagnostic category containing “symptoms, signs, or clinical findings.” Crucially, the code associated with the diagnosis – a designation that is needed to register new drugs and therapies-included the word “pathological,” which could have been interpreted as suggesting that old age is a disease in itself.
Some researchers looked forward to the revision, seeing it as part of the path toward creating and distributing anti-aging therapies. But Rabheru, a professor at the University of Ottawa and a geriatric psychiatrist at the Ottawa Hospital, feared that these changes would only further ageism. If age alone were presumed to be a disease, that could lead to inadequate care from physicians, he says. Rather than pinpoint exactly what’s troubling a patient, a problem could simply be dismissed as a consequence of advanced years.
Rabheru became part of a group that secured the call with the catalogue team. Those on his side presented their arguments and, he says, were “very pleasantly surprised” by the response-a formal review followed by a retraction. On January 1, 2022, the 11th version of the ICD was released without the term “old age” – or language that suggests aging is a disease – in its contents. The decision wasn’t welcomed by everyone. “My question to the scientists and doctors who protested the inclusion of old age in their handbook is: What is so threatening?” David Sinclair says. “I would really love to know the motivation, besides just trying to maintain the status quo.” Sinclair is also concerned about ageism. But he argues that the best way to combat ageism is to tackle aging: facing the problem head-on by devising treatments to slow its progress. “The current view that aging is acceptable is ageism in itself.”
In the years leading up to the debut of ICD-11, a number of researchers argued that linking old age more directly to disease would help the field of longevity research overcome regulatory obstacles, paving the way for drugs designed specifically to treat aging. This issue, however, is seemingly becoming less of a concern as anti-aging research becomes more mainstream. The US Food and Drug Administration, for example, has said it doesn’t consider aging a disease. But in 2015, the agency made the surprising decision to greenlight the Targeting Aging with Metformin (TAME) study, a clinical trial that aims to show that aging can be targeted head-on, by testing whether the diabetes drug metformin can delay the development or progression of chronic diseases associated with aging.
Sinclair sees the WHO’s decision as a temporary setback. “Fortunately, the momentum is there from scientists, from the public, from investors. This is going to happen, and changes to some of the language in a document aren’t going to stop progress. Still, language is extremely important to how society views problems and potential solutions.”