Tuesday, May 13, 2014

Only perfect people need apply

It is a known fact that clinical trials are very selective when creating their selection criteria for who to include. (That is not a grammatical sentence but its early in the day here.) What I am trying to say is that if you do not fit their criteria, you will not be included. I have so many ailments, I have never been included in a clinical trial. They don't want me.

Hop on over the clinicaltrials.gov and see if you would fit their criteria for any. They are very specific. Basically they are trying to determine toxicity, dosage and more. An abbreviated version of the official government description of the different stages are:

"Phase 0: Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (for example, screening studies, microdose studies).
Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. 

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). 

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing. These including postmarket requirement and commitment studies that are required of or agreed to by the sponsor."

In Phase 2 and 3 trials, the most common ones we hear about and participate in, are where the drug manufacturers select their groups of patients who have the disease that they hope to treat. But they routinely exclude people with other issues who might not conflict with the trials or cause side effects that could be from the new drug or from the other issues. So you have to be perfect.

A growing problem is that with the aging population as the Boomer generation about to hit their 70s, older patients are being treated with new drugs that have not been tested on their age group.

"For at least 25 years, it’s been known that drugs that work one way in an otherwise healthy younger adult might not work the same way in the elderly. Many older adults are frail and might metabolize medications more slowly or suffer unforeseen drug interactions. Blood thinners, for example, might be riskier in someone with a tendency to fall. Medications to control blood pressure could be harder to dose appropriately in a patient with poor kidney function. In 1989, the FDA set guidelines encouraging drug companies to study how their drugs affect the elderly, with the goal that the population being studied prior to drug approval should resemble the population that would ultimately take the medications. But the guideline was not a mandate...." 

"...one in five trials excluded potential participants based on their age alone. In half of the remaining trials, patients were excluded from participating because of conditions that disproportionately affect older adults, such as cognitive dysfunction or limited physical activity. And only one quarter of the studies looked at outcomes that might be relevant to older adults, such as quality of life or physical function." 

So for all of us imperfect people out there, you can understand the issues here with multiple health issues, never mind age, which may cause us additional problems through treatment.

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