Many praises are being sung about the bipartisan 21st Century Cures Act, which President Obama signed into law Tuesday afternoon. The law provides billions of dollars in funding to help states address opioid abuse and addiction, mental health care, precision medicine research, and Alzheimer’s and cancer research.
The law represents what many believe is the first legitimate effort to address the opioid crisis and the deplorable state of our mental health care system.
“The simple fact that the 21st Century Cures Act received bipartisan support, and addiction and mental health are provisioned alongside other major diseases such as cancer or Alzheimer’s, is a huge victory in and of itself,” said Ruchi Dhami, director of research at Recovery Brands in San Diego, California. Recovery Brands provides online resources for people seeking help with substance abuse so that they can identify the treatment options that are best for their situation — a Yelp of sorts for recovery options.
Researchers estimate that 2.6 million people struggle with opioid dependence in the United States, and the number of people dying from overdoses just keeps increasing. More than 28,000 people died from overdose in 2014 — a higher number than any other year on record.
“Dramatically speeding up the FDA’s drug approval through the use of surrogate endpoints and biomarkers alone has been shown to be a bad idea,” said one pharmacology expert.
“[The Act] demonstrates a cultural shift in the way we view and recognize the illnesses, as well as the critical need to effectively treat the diseases with science — and evidence-based solutions. More importantly, the Act allocates the financial means necessary to do so.”
The bill also marks what some say will be landmark shifts in the health and science communities. Greater emphasis will allegedly be placed on giving patients greater power to navigate their illnesses and their care. A special “NIH Innovation Fund” also authorizes the Food and Drug Administration to explore smaller clinical trial models that would allow drugs to be approved faster for therapeutic use.
Not everyone, though, agrees this will be a panacea for patients. There are concerns about how much influence lobbyists for the drug and medical device industry had in the process.
[lz_third_party align=center includes=https://twitter.com/jsross119/status/809026050579714052]
“Ten years from now, someone with a cancer diagnosis will be worse off with this bill,” Dr. Vinay Prasad, an oncologist at Oregon Health Sciences University, told Trudy Lieberman of Rural Health News Service. “People will be exposed to more things that don’t work.”
Prasad has concerns the Cures Act actually lowers the regulatory standards for drugs and devices and added, “It’s a step backward for patients.”
Pharmacology and drug safety expert, Dr. David Gortler, agreed with that.
“I think Congress’ heart is in the right place for wanting to increase the budget for curing diseases. But dramatically speeding up the FDA’s drug approval through the use of surrogate endpoints and biomarkers alone has been shown to be a bad idea,” Gortler, an FDA policy expert at FormerFDA.com, told LifeZette when the bill initially passed last week through Congress.
With the bill now signed into law, he said Commissioner Robert Califf and the FDA are not doing a good job now of reviewing drugs, having made some highly questionable decisions in the recent past. “Califf himself is the one who approved Oxycontin in children as young as 11 years old.”
He doesn’t believe bad behavior is rewarded by throwing more money at it. “If an organization isn’t operating intelligently, you don’t try to speed it up! The 21st Century Cures Act will speed up the already flawed reviews process at the FDA. The bill was written very broadly by politicians who have no idea how drug discovery and drug research work, and sponsored by pharmaceutical and device manufacturers; that tells a lot.”