为什么“大型制药公司”永远不会生产廉价的抗衰老药物
Why 'Big Pharma' Will Never Make A Cheap Anti-Aging Drug

原始链接: https://www.zerohedge.com/medical/why-big-pharma-will-never-make-cheap-anti-aging-drug

像二甲双胍(metformin)和雷帕霉素(rapamycin)这样的仿制药在动物实验中展现出延缓衰老的潜力,但严谨的人体临床试验仍然罕见。主要障碍在于资金:由于这些药物价格低廉且专利已过期,制药公司无法通过垄断来收回三期临床试验的高昂成本。此外,由于“衰老”目前并非可报销的医疗病症,因此资助此类研究的商业动力不足。 为了绕过这一问题,业界正转向测试针对特定疾病的新型专利药物,并同时监测衰老生物标志物。其目标是收集足够的数据,以说服监管机构将衰老归类为可治疗的疾病,这可能效仿近期肥胖症被重新定义的方式。 与此同时,在私营部门缺位的情况下,独立机构正在介入。诸如“二甲双胍靶向衰老”(TAME)试验以及德克萨斯大学的新研究等项目,正寻求慈善机构和政府的资助,以确定这些普及型药物是否真的能够延长人类的健康寿命。

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原文

Authored by Ross Pomeroy via RealClearScience,

For years, scientists have hypothesized that safe, cheap, generic drugs like metformin and rapamycin could slow aging, based on promising findings in animal models. But despite the evidenced hope, little has been done to see if these drugs actually slow aging in humans. There have been no rigorous clinical trials exploring whether metformin or rapamycin prolong life and and boost health.

How is it possible that metformin and rapamycin, long used to respectively treat diabetes and prevent organ transplant rejection, have had their anti-aging potential ignored for so long? To conspiracy-minded critics of 'Big Pharma', the answer is obvious: there's no money in it. In this case, they seem to be correct. Speaking at the 12th Aging Research and Drug Discovery (ARDD) meeting convened at the University of Copenhagen last summer, industry leaders conceded the point.

"Repurposing cheap, off-patent drugs like metformin fails mathematically. Phase 3 clinical trials cost hundreds of millions of dollars. Companies cannot recover this money without a patent monopoly. Therefore, the industry tests new, patented drugs for specific diseases."

Rapamycin costs between $40 and $150 per month out of pocket. Metformin is even cheaper, between $4 and $20 per month. To pharmaceutical companies, this meager revenue simply doesn't justify an expensive clinical trial to treat a nebulous medical condition like "aging," which insurers don't even consider reimbursable. To put it bluntly, treating aging with generic drugs may be economical and worthwhile for humans and society as a whole, but it isn't commercially viable for pharmaceutical companies.

The industry leaders speaking at ARDD explained a strategy that makes more financial sense.

"Industry tests new, patented drugs for specific diseases. During these trials, researchers simultaneously measure aging biomarkers like epigenetic clocks. This secondary strategy generates the hard numbers of regulators demand. The goal is to force regulators to classify aging as a reimbursable medical condition. This mirrors how objective data transformed obesity from a lifestyle choice into a treated disease."

So it's possible that what recently happened with obesity and GLP-1s will one day happen with aging.

In the meantime, independent institutions are trying to launch efforts to explore metformin and rapamycin's anti-aging potential in humans. The American Federation for Aging Research has - for a decade now - sought "visionary donors" to begin their Targeting Aging with Metformin (TAME) Trial, a six-year study testing whether metformin can delay development or progression of age-related chronic diseases in 3,000 adults aged 65-79. Earlier this year, scientists at The University of Texas at San Antonio secured funding from the National Institute on Aging to carry out a including a "randomized, placebo-controlled clinical trial involving approximately 84 older adults who will receive either daily rapamycin, intermittent dosing or a placebo" for six months, while monitoring the treatment's effects.

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