Late last year, the 21st Century Cures Act was signed into law after it quickly was approved in the Senate and Congress. This act sets out, among other goals, to get medications to market faster. Many of my colleagues fear it could be dangerous to push medications that may not be ready through FDA hurdles and into patients’ hands. Others feel that this may be the cure for finally treating diseases effectively and quickly.
The fear that medications will not be analyzed for safety is simply not true. The FDA will still regulate medications for safety and efficacy. While clinical trials, the gold standard of evidence-based medicine, may not take years any longer, new methods of statistical analysis are encouraged. No one said we would no longer hold true to the values of clinical safety. Rather, we need to make these evidence-based determinations in a faster manner.
No Time to Wait
Many patients are suffering for a lack of a cure. Some have terminal diseases for which no cure exists. They have been given a death sentence and don’t have time to wait for years of clinical trials to be cured. They will simply die first. Some patients have rare diseases that no one knows how to treat. They may live their whole life with no answers. It is not for pharmaceutical company profits that we wish speedy medications, but rather for the patients languishing and dying. Don’t they deserve a chance for a cure?
As life expectancy rises in the U.S., so do the years lived with chronic diseases. These diseases can cause great damage to the body the longer they exist. Most know that patients with diabetes are at risk of end organ damage, such as kidney failure, heart attack, stroke, and blindness. Hypertension puts strain on the heart and can lead to heart failure. While we have an arsenal of medications to fight off these complications, we still need more. Preventing the chronic disease complications we know so well should be a top priority. The faster we develop medications needed to do this, the more organs we will save, and the more years of healthy living we will add to those suffering chronic medical problems.
And then there are those horrific debilitating diseases that may have some treatments, but no good ones. Alzheimer’s dementia continues to be devastating for both patients and family members. There has been no advancement in the treatment for many years. The medications we have often make little difference. We need medications that not only cure disease, but also improve quality of life.
The 21st Century Cures Act is not a big pharma profit ploy as some contend. Rather, it is a win for suffering patients—with the potential to bring cures more quickly to patients who have no hope left.