Earlier this week, President Obama signed the controversial 21st Century Cures Act into law. The bill is vast and has the power to drastically change the way the FDA works with pharmaceutical companies — not necessarily for the better.
But, with an investment of over $6 billion, it also has the potential to seriously power our fights against the opioid epidemic, mental health crises, and even cancer. Here are four ways the act could influence your life and your health.
1. The Opioid Epidemic
The act specifically designates $1 billion over two years to fight the opioid epidemic. This will go to state efforts such as making treatment programs more accessible, training healthcare professionals to better care for people dealing with addiction, and conducting research into the most effective approaches to prevent dependency. This comes a few months after the passage of the Comprehensive Addiction and Recovery Act (CARA), which promotes many harm-reduction strategies, including increased access to the overdose reversal drug naloxone, for the opioid crisis — but doesn't provide any federal funding to actually implement them. So, this bill may actually help move the needle on getting many people the help they need. 2. Mental Health
There's also a substantial portion of the bill dedicated to mental health issues. For instance, it bolsters mental health parity laws, which require insurance companies to treat mental health treatments just like medical treatments. It also includes grants to provide community mental health resources, suicide prevention and intervention programs, and de-escalation training for law enforcement. The National Alliance on Mental Illness (NAMI) celebrated the act's passage in a statement saying, "We are one step closer to NAMI’s vision of an America where fewer people with mental illness end up on the streets, out of school, or in jail." 3. The FDA
This part of the bill is aimed at getting new drugs and devices approved more quickly. But that means doing away with (or seriously altering) some steps in the approval process that we've come to expect. That includes easing the requirements put on drug companies looking for FDA approval on new products or new indications on existing drugs. For instance, the act allows companies to provide "data summaries" rather than full clinical trial results in some cases. Unsurprisingly, these parts of the act have received a fair amount of criticism from voices on the left, including Senators Elizabeth Warren and Bernie Sanders. But other parts aren't as scary as they sound. For example, there's a section that allows researchers to waive the requirement for "informed consent" in certain circumstances, which makes it seem like scientists are going to be able to unleash all sorts of experiments on unwitting patients. However, the exception only applies in specific cases where the devices being tested don't pose any health risks beyond those of normal everyday life and wouldn't direct a patient's care in any way, says Anthony Magit, MD, director of the Human Research Protection Program at UCSD. One example Dr. Magit gives is that of a high-tech bandage that monitors blood flow from a serious wound, which functions just like a regular bandage but only has this added benefit of possibly monitoring blood flow. Ideally, if researchers were to test any new device on a patient, they would get that patient's permission. But in the case of this bandage, for example, this would also need to be tested in a battlefield situation in which patients might not be conscious, which would make it difficult to get their consent. In the end here, the informed consent makes very little difference to the patient because they're still getting all of their regular, medically accepted care (e.g. blood pressure and heart rate monitoring) in addition to the blood flow measurements. But with the news rules, this kind of trial may be easier to perform without an overly strict informed consent policy. Plus, there's still plenty of oversight even in these cases. "Any research involving human subjects is highly regulated," Dr. Magit says. "It's built into federal regulation that whoever looks at [a study involving human participants] is a mix of individuals there to protect the community plus [ensure] good science and good research ethics."
4. The Cancer Moonshot
As part of a larger $4.8 billion investment in precision medicine and biomedical research, the act promises $1.8 billion to accelerate cancer research through Vice President Joe Biden's moonshot initiative. This part of the bill was even renamed the "Beau Biden Cancer Moonshot" in honor of the VP's late son, who died last year after battling brain cancer. "There are 15.5 million cancer survivors who are alive today because of cancer research,” said Nancy Davidson, MD, president of the American Association for Cancer Research, in a press release. “[President Obama signing the Cures Act] provides us with a down payment for the resources necessary to save more lives from cancer.”
The act specifically designates $1 billion over two years to fight the opioid epidemic. This will go to state efforts such as making treatment programs more accessible, training healthcare professionals to better care for people dealing with addiction, and conducting research into the most effective approaches to prevent dependency. This comes a few months after the passage of the Comprehensive Addiction and Recovery Act (CARA), which promotes many harm-reduction strategies, including increased access to the overdose reversal drug naloxone, for the opioid crisis — but doesn't provide any federal funding to actually implement them. So, this bill may actually help move the needle on getting many people the help they need. 2. Mental Health
There's also a substantial portion of the bill dedicated to mental health issues. For instance, it bolsters mental health parity laws, which require insurance companies to treat mental health treatments just like medical treatments. It also includes grants to provide community mental health resources, suicide prevention and intervention programs, and de-escalation training for law enforcement. The National Alliance on Mental Illness (NAMI) celebrated the act's passage in a statement saying, "We are one step closer to NAMI’s vision of an America where fewer people with mental illness end up on the streets, out of school, or in jail." 3. The FDA
This part of the bill is aimed at getting new drugs and devices approved more quickly. But that means doing away with (or seriously altering) some steps in the approval process that we've come to expect. That includes easing the requirements put on drug companies looking for FDA approval on new products or new indications on existing drugs. For instance, the act allows companies to provide "data summaries" rather than full clinical trial results in some cases. Unsurprisingly, these parts of the act have received a fair amount of criticism from voices on the left, including Senators Elizabeth Warren and Bernie Sanders. But other parts aren't as scary as they sound. For example, there's a section that allows researchers to waive the requirement for "informed consent" in certain circumstances, which makes it seem like scientists are going to be able to unleash all sorts of experiments on unwitting patients. However, the exception only applies in specific cases where the devices being tested don't pose any health risks beyond those of normal everyday life and wouldn't direct a patient's care in any way, says Anthony Magit, MD, director of the Human Research Protection Program at UCSD. One example Dr. Magit gives is that of a high-tech bandage that monitors blood flow from a serious wound, which functions just like a regular bandage but only has this added benefit of possibly monitoring blood flow. Ideally, if researchers were to test any new device on a patient, they would get that patient's permission. But in the case of this bandage, for example, this would also need to be tested in a battlefield situation in which patients might not be conscious, which would make it difficult to get their consent. In the end here, the informed consent makes very little difference to the patient because they're still getting all of their regular, medically accepted care (e.g. blood pressure and heart rate monitoring) in addition to the blood flow measurements. But with the news rules, this kind of trial may be easier to perform without an overly strict informed consent policy. Plus, there's still plenty of oversight even in these cases. "Any research involving human subjects is highly regulated," Dr. Magit says. "It's built into federal regulation that whoever looks at [a study involving human participants] is a mix of individuals there to protect the community plus [ensure] good science and good research ethics."
4. The Cancer Moonshot
As part of a larger $4.8 billion investment in precision medicine and biomedical research, the act promises $1.8 billion to accelerate cancer research through Vice President Joe Biden's moonshot initiative. This part of the bill was even renamed the "Beau Biden Cancer Moonshot" in honor of the VP's late son, who died last year after battling brain cancer. "There are 15.5 million cancer survivors who are alive today because of cancer research,” said Nancy Davidson, MD, president of the American Association for Cancer Research, in a press release. “[President Obama signing the Cures Act] provides us with a down payment for the resources necessary to save more lives from cancer.”