Recently, the U.S. Senate passed the 21st Century Cures bill with an overwhelming vote of 95-4 and was approved by President Obama. Yet, the controversy continues. Some people worry that this act is destroying our scientific process and sacrificing patient safety issues. Others proclaim that this is a win for the big pharmaceutical companies, who are already winning by a landslide. And then, there are the voices shouting out with all their might that this is what patients need. In fact, the 21st Century Cures Act is a huge win for patients.
What changes under the 21st Century Cures Act?
- $4.8 billion dollars will be allocated to establish the National Institute of Health (NIH) and Cures innovation fund. This money will be spent on developing a strategic plan and implementing it, as well as conducting research, around biomedical science.
- New rules will be developed that direct the Food and Drug Administration (FDA) to approve drugs and devices with greater urgency.
- Money will be given to states to help in the fight against the opioid epidemic.
- There will be a boost given to mental health care.
I doubt few would argue that most of these issues require assistance. Patients are suffering, and they do not possess the tools to battle the things that are afflicting them. Doctors are often limited as well. Recently, I spent more than a month trying to find a rehab program for a teen addicted to IV heroin who wanted to quit. There were no services available for him. Patients with rare diseases are often out of luck because, for them, many of the treatments don’t exist and, if they do, they are only used off-label. As a doctor, it breaks my heart to stand in front of a patient, or the parents of a patient, and tell them there is not enough knowledge to treat them. Their suffering must be intense when the whole system fails them.
In the 21st century, patients are living longer than ever before with more complex diseases. Research must be conducted to keep pace, and we cannot leave anyone out, no matter how few people suffer from it. Everyone deserves the chance of a cure. If we fail to offer that, we all lose because our system is flawed.
The opioid crisis is not only causing hurt — it is killing people. It doesn’t only affect the victims, but the families of the victims suffer greatly. So many parents come crying to me because they want to help but do not know what to do. I try my best but often there is nothing to give them.
Mental health has been largely ignored and stigmatized for decades. Patients with mental health disorders hide it because of this. These diseases are just as real as asthma or diabetes or any physical disease. It is time to provide them the resources so they can come out from hiding and get the treatment they should have been receiving all along.
The opponents of this bill proclaim that pharmaceutical companies are the big winners. They spin the story like all these dangerous drugs and devices will now be allowed to sneak past the FDA for these companies’ profits. Yes, this act is an advantage for them, but no, they will not be able to sneak through anything they wish just to make a buck. The FDA will still be overseeing the process, and part of the Cures Act instructs the FDA to establish alternate statistical research methods to determine drug safety. It will just be a faster, different process than the one we are doing now. The gold standard has always been the clinical trial which can take years to complete. Many patients do not have years of life left to wait. We need to help them now. And we have all seen drugs undergoing rigorous clinical trials later being pulled from the market after they were found to have safety issues.
Science is not being destroyed, medicine is not being destroyed. Rather, this act is igniting hope for many who have lost all hope. There are many winners in the passage of this bill, but I say the biggest winners are the patients. Now, it is time to start the plan on how to implement this act in the safest way possible while keeping the patient center stage. Let’s cast away political agendas and get to work. Who is ready to help?
Linda Girgis is a family physician who blogs at Dr. Linda.
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