The 21st Century Cures Act: Pros and Cons

By: Annette McElhiney

The 21st Century Cures Act: Pros and ConsWhat lies ahead this year for health care and cancer care? I’m not a medical doctor, I’m just an 8½-year ovarian cancer survivor in remission. Who knows, the disease could come back 20 years later. So how do I plan my life to make certain I’m prepared to address a recurrence when it occurs? In addition to eating and behaving in ways to promote good health, including alleviating negative stress, I believe in informing myself about the pros and cons of every health issue.  Consequently, I’ve been reading about and noting the positives and negatives of the 21st Cures Act.

First, I asked what does this act mean? In President Obama’s words:

“The Cures Act makes important investments that will save lives. First, for the families and communities that have lost too many loved ones to the heroin and prescription opioid epidemic, it invests the $1 billion I requested in my budget to address this crisis. Second, the bill answers the Vice President’s call for a Moonshot in cancer research by investing $1.8 billion in new resources to accelerate discoveries. Third, it invests nearly $3 billion to build upon the major biomedical research initiatives we have launched in my Administration – known as the BRAIN and Precision Medicine Initiatives – which are tackling diseases like Alzheimer’s and creating new research models to find cures and better target treatments. Fourth, the Cures Act takes important steps to improve mental health, including building on the work of my Administration’s Mental Health and Substance Use Disorder Parity Task Force. And fifth, the legislation advances the progress we’ve made in improving the Food and Drug Administration’s drug development process by, for example, making sure patients’ voices are part of those decisions.”

Certainly, nothing stated here raises immediate questions. Both Republican and Democrats supported the bill. But in seeking many evaluations of the winners and losers in the bill, I found widely different levels of enthusiasm. Below, NPR presents the winners and the losers in their bill. Click here to read their article.

Winners

Pharmaceutical and Medical Gadget Companies

“The law would likely save drug and device companies billions of dollars when it comes to bringing products to market by giving the Food and Drug Administration more discretion in the kinds of studies required to evaluate new devices and medicines for approval.

The changes represent a massive lobbying effort by 58 pharmaceutical companies, 24 device companies and 26 biotech companies, according to a Kaiser Health News analysis of lobbying data compiled by the Center for Responsive Politics. The groups reported more than $192 million in lobbying expenses on the Cures Act and other legislative priorities, the analysis shows.”

Next NPR suggests how the medical community will profit.

Medical Schools, Hospitals and Doctors

“The law would provide $4.8 billion over 10 years in additional funding to National Institutes of Health, the federal government’s main biomedical research organization. (The funds aren’t guaranteed, however, and would be subject to annual appropriations.)

The money could help researchers at universities and medical centers get hundreds of millions more dollars in research grants, most of it toward research on cancer, neuroscience and genetic medicine. Medical schools, hospitals and doctors.

The law would provide $4.8 billion over 10 years in additional funding to National Institutes of Health, the federal government’s main biomedical research organization. (The funds aren’t guaranteed, however, and would be subject to annual appropriations.)

The money could help researchers at universities and medical centers get hundreds of millions more dollars in research grants, most of it toward research on cancer, neuroscience and genetic medicine.”

Furthermore, NPR sees gains in terms of drug abuse and mental health.

Advocates For Mental Health and Substance Abuse Treatment

“The law would provide $1 billion in state grants over two years to address opioid abuse and addiction. While most of that money would go to treatment facilities, some would fund research.

The Cures Act would also boost funding for mental health research and treatment, with hundreds of millions of dollars authorized for dozens of existing and new programs.”

Patient Groups

“Groups focused on specific diseases and patient advocacy generally supported the legislation and lobbied vigorously for it. Many of these groups get a portion of their funding from drug and device companies. The bill includes more patient input in the drug development and approval process, and if it becomes law would boost the clout of such groups.”

Health Information Technology and Software Companies

“The law would push federal agencies and health providers nationwide to use electronic health records systems and to collect data to enhance research and treatment. Although the Cures Act wouldn’t specifically fund the effort, IT and data management companies could gain millions of dollars in new business.”

Losers

Public Health

“The Cures Act would cut $3.5 billion — about 30 percent — from the Prevention and Public Health Fund established under Obamacare to promote prevention of Alzheimer’s disease, hospital acquired infections, chronic illnesses and other ailments.”

Consumer and Patient Safety Groups

“Groups like Public Citizen and the National Center for Health Research either fought the bill outright or sought substantial changes. Although they won on some points, these groups still say the Cures Act opens the door for unsafe drug and device approvals and doesn’t address rising drug costs.”

Patients Seeking Hair Growth

“The act says Medicaid would no longer help pay for drugs that help patients restore hair. The National Alopecia Areata Foundation spent $40,000 on lobbying disclosures this cycle that included the Cures Act.”

Food and Drug Administration

“The law would give FDA an additional $500 million through 2026 and more hiring power, but critics say it isn’t enough to cover the additional workload under the bill. The agency also would get something it has opposed: renewal of a controversial voucher program that rewards companies for getting drugs approved to treat rare pediatric diseases.”

To see the entire article. (I’ve omitted some points) click here.

Regarding ovarian cancer treatment, what do I see as a survivor? Knowing that only 1out of 73 gets ovarian cancer and that few pharmaceutical company budgets allow them to focus specifically on treatment drugs, I see the act mostly as positive.

In addition, the financial support for Precision Medicine programs based on molecular profiles (like The Clearity Foundation) sound great; as does increased funding to doctors, hospitals and researchers. Development and use of larger electronic data banks would seemingly support clinical use of genomic data.

Of course, I do understand the critics’ concern about insufficient support of the FDA to assure safety of a drug. But, the bill has passed. Perhaps it is time to refine and address its flaws.

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