Clinical trials exclude older adults to improve their outcomes

I often report on the over-abundance of poorly designed clinical trials and other medical research out there. Far too many rely on faulty assumptions, sloppy methodology, statistical manipulations, and outdated concepts and tools in their examination of diet and nutrition and serious conditions such as cancer, heart disease, and Type II diabetes.

Plus, the majority of medical research today also suffers from age bias. This kind of bias happens when researchers only test new treatments on younger people—excluding older people with chronic diseases who actually need the treatments being studied. (This trick also makes new treatments seem to be more effective than they actually might be when used on older adults who need them.)

Thankfully, this huge problem is finally garnering some attention by government agencies and the mainstream press.

In fact, our local newspaper—the Herald Tribune of Sarasota, Florida—recently ran a story about the National Institutes of Health’s (NIH) new analysis of age bias in clinical trials. I was especially pleased to see it run outside of a scientific journal, as there are still plenty of people who read print newspapers and who are concerned about these kinds of topics, especially older people.

NIH tackles age bias in research

For this new analysis, NIH researchers looked closely at clinical trials conducted between 1965 and 2015 that examined treatments for lung diseases, heart failure, osteoarthritis, and prostate cancer. These conditions are the top reasons why older people become disabled and require hospitalization. And the trials that the NIH analyzed were designed to test the efficacy of new treatments and their suitability in clinical practice.

But…

It turns out, 33 percent of clinical trials set overly strict age limits. Worse yet, 65 percent of the trials involved participants who were younger than the population typically affected by the actual conditions being studied!

The article quoted Sue Peschin, president and CEO of the Alliance for Aging Research in Washington, D.C. (I occasionally worked with this group from about 1990 to 2005, together with the former U.S. Surgeon General C. Everett Koop.) Peschin agreed that not including older people in clinical trials on medical treatments is a huge problem.

For one, older adults have special health needs that are different from those of younger adults. Second, older adults rarely react the same way as younger adults to treatments. In fact, older adults often have stronger adverse reactions and less-pronounced beneficial reactions to new medical treatments when compared to younger adults.

In the end, without this important data, we don’t know if new medical treatments will actually work in older people or not.

Plus, this isn’t the first analysis to show age bias in medical research, as I reported in the March 2017 issue of my Insiders’ Cures newsletter (“Revealed: What the mainstream DOESN’T know about heart disease in older adults”). No yet a subscriber? No problem. Just click here.

Previous analyses from Harvard Medical School and the University of Michigan also showed that clinical trials often set arbitrary age limits and intentionally exclude older people. And yet, these studies go on to get published in leading medical journals, which drive clinical practice guidelines.

Interestingly, there’s even age bias in lab research on rodents. Aging rodents are preferable in lab research, as they’re closer biologically to aging people.

But aging rodents cost much more. In fact, an “older” mouse can cost more than $300, whereas a “younger” mouse costs about $75. So, here again, researchers often opt for the younger mice, because they can’t afford the older ones!

Real change needs to happen at the FDA, not just NIH

Starting last January, the NIH began requiring research grant applications to explain how they intend to include people of all ages. But these requirements apply only to the more-basic research supported by the NIH.

Most medical research—almost three times as much as what the NIH funds—gets funneled through the Food and Drug Administration (FDA) for approval. So, it’s really the FDA that needs to step up to the plate and require data on older people.

The bottom line is this…

Billions and billions of dollars have been spent on medical research in the U.S. over the past 50 years. But much of that research is questionable because it excluded older people—people who need the treatments the most, and who’ve been paying for such research with tax dollars their whole working lives.

Just chalk this one up as another reason to avoid today’s mainstream medical care whenever possible.

Fortunately, many natural strategies can help you stay healthy and vibrant well into your 70s, 80s, 90s, and beyond. You can learn all about these healthy aging strategies in my protocol, The Insider’s Ultimate Guide to Outsmarting “Old Age.” If you’d like to learn more about this online learning tool or enroll today, simply click here.

Source:

“Does new promise to include seniors in research go far enough?” Herald-Tribune (heraldtribune.com/news/20190406/does-new-promise-to-include-seniors-in-research-go-far-enough) 4/6/2019

“Adequacy of Inclusion of Older Adults in NIH-Funded Phase III Clinical Trials.” J Am Geriatr Soc. 2019 Feb;67(2):218-222. (doi.org/10.1111/jgs.15786)


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