“The 21st Century Cures Act” Is On Its Way – Here’s Why You Haven’t Heard About It
The 21st Century Cures Act is going through the U.S. Congress right now, and it will likely pass into law unless some opposition materializes (it passed through the House of Representatives Energy and Commerce Committee with a vote of 51 to 0). The Act is a give-away to the pharmaceutical industry, removing many of the safety mechanisms in place that are supposed to keep the public protected from unsafe drugs and medical devices.
The 21st Century Cures Act allows drugs to be rushed to the market, removes phase 3 testing as a requirement for drug approval, bases drug approval on biomarkers rather than actual health outcomes, and encourages the production of new antibiotics at a time when microbiome destruction is increasingly being linked to chronic diseases.
The Loss of Informed Consent
The 21st Century Cures Act will diminish another bedrock of modern medicine – informed consent.
The NEJM article notes that:
“Informed consent by patients in drug trials has traditionally been sacrosanct, with exceptions made only when consent is impossible to obtain or contrary to a patient’s best interests. But another clause in the proposed law adds a new kind of exception: studies in which ‘the proposed clinical testing poses no more than minimal risk’ — a major departure from current human subject protections. It is not clear who gets to determine whether a given trial of a new drug poses ‘minimal risk.’”
Informed consent is crucial not only for the credibility of modern medicine, it is crucial for liberty.
