As of last month, the people who keep close track of these matters, namely ResearchAndMarkets.com, have identified more than 80 pharmaceutical firms that currently have more than 100 new anti-obesity drugs in the “pipeline,” the wide area that exists in between the gleam of inspiration and the marketing of a finished product. Naturally, the public expects that a medicine offered for sale has jumped through every possible hoop, and is as safe to use as human ingenuity can make it.
There are so many types of products, based on so many different molecules, with several possible routes of administration, and each one of them is in a different stage of development or testing. The test parameters will depend on whether the route of administration is oral, subcutaneous, parenteral, intravenous, topical, or other. And what about its type? Recombinant fusion proteins, small molecule, monoclonal antibody, peptide, polymer, or other?
There is clinical assessment, and then there is of course commercial assessment. What are the product’s “growth prospects”? This means, in business-speak, how soon can we get this product on the market and how much can we sell it for, and how much can we make off it every year going forward? And can our product become the top dog, the one undeniable and universally acknowledged winner that leaves all other contenders in the dust?
Between discovery and permission for unfettered sales, a hopeful drug faces many stages of trial and possible rejection. Concerning all of these 100+ hopeful entries in the anti-obesity sweepstakes, answers are anxiously awaited by financial officers of the companies, stockholders, the medical establishment, and the public.
And then, there’s this
What many people fail to understand, or choose to ignore, about the majority of products with strongly established market shares — products that have already been accepted, and that are used by millions of people — is that a distressing number of significant questions about them are equally unanswered. How can this be? As it turns out, it is because those questions have not been asked. The title of an article by Jonel Aleccia is a simple declarative sentence: “Drugs aren’t required to be tested in people who are obese.”
In the USA, somewhere around 40{e60f258f32f4d0090826105a8a8e4487cca35cebb3251bd7e4de0ff6f7e40497} of adults are filed in the obese category. And yet, an astonishing number of the familiar medications, both prescription and over-the-counter, have not been tested on officially obese human bodies. The writer states:
That’s because they are not required to be included in drug studies. And often, they’re explicitly excluded.
Many widely prescribed drugs and over-the-counter medications work differently in people who are obese, but exactly how and at what dose often isn’t clear.
At a workshop last year, FDA Commissioner Dr. Robert Califf acknowledged a “deficit of evidence” about how medicines act in patients who are obese. The NIH now encourages researchers to consider the impact of excluding obese people in their studies…
Aleccia cites work done by drug researcher Christina Chow, who recently reviewed over 200 new drug studies, of which almost two-thirds did not document the subjects’ weight or BMI. Apparently, most drugs of every kind that have ever made it to the market were tested primarily on Caucasian adult males. Sure, we don’t want the health or lives of vulnerable populations to be put in danger. Any kind of testing on children, expectant mothers, or anyone whose health is already compromised needs to be conducted with the utmost care.
But fat people get the flu too, and experience pain, and become accidentally pregnant, and suffer every malady that remedies have been devised for. Considering how many of them there are, medicines that work for them are definitely needed, along with definitive information on how to calculate the effective dose considering their body weight. Chow explains the dangers of not weight-relating certain specific drugs, including one that treats schizophrenia, the emergency conception prevention drug, and even ibuprofen:
Some drugs can become concentrated in fat tissues and not in the bloodstream. That means there will be less medication in the blood, leading to undertreatment… Other drugs remain in the body longer in the obese. That could result in harmful drug interactions if another medication is added too soon.
One group needs to be figured out quickly, considering its ever-growing number of members. More and more elderly people just hang in there and refuse to become extinct. How are scientists expected to use them as test subjects? But how can they not? And every day the senior citizen count increases, including a goodly number of obese senior citizens.
Your responses and feedback are welcome!
Source: “Obesity Pipeline Research 2024,” GlobeNewsWire.com, 06/26/24
Source: “Drugs aren’t required to be tested in people who are obese,” Archive.is, 11/07/23
Image by Aaaarrrrgggghhhh!/Attribution 2.0 Generic
