In the healthcare industry—notoriously full of red tape—it’s hard to get anything done quickly. An exception to the rule might be the FDA’s accelerated approval pathway, which the agency created in 1992 to speed up the approval process of drugs for serious diseases with limited treatment options.

The pathway began in response to the AIDS epidemic, and today most of the drugs approved through this pathway are designed to treat different types of cancer. However, these drugs cost the US healthcare system a lot of money, and in many cases, the clinical benefit is minimal or unknown.

‘We really don’t know if they have clinical benefit or not’

The FDA evaluates accelerated approval drugs based on a “surrogate endpoint”—a measure that shows whether the drug is likely to be clinically beneficial for patients—rather than evidence that the drug is actually effective.

After approval, drugmakers are required to go back and do another trial to confirm the drug is beneficial. But the FDA is historically lax at enforcing deadlines for these confirmatory trials, and as a result, the clinical benefit of many accelerated approval drugs is largely unknown.

“Many different studies have suggested that for certain diseases, certain indications, we have drugs that we really don’t know if they have clinical benefit or not,” said Gregg Gonsalves, a professor of epidemiology at Yale School of Public Health who has expertise in health policy.

A 2022 study published in JAMA found that “many drugs granted FDA accelerated approval lack evidence of clinical benefit, even after being converted to standard approval, yet they account for substantial CMS [Centers for Medicare and Medicaid Services] spending.”

Keep reading here.—MA

Do you work in healthcare or have information about the industry that we should know? Email Maia at [email protected]. For completely confidential conversations, ask Maia for her number on Signal.

The shortage of direct care workers, who provide home care services, is “the single greatest barrier” to people with intellectual and developmental disabilities (IDD) accessing long-term supports—and it’s “damaging the structural integrity of the community-based services system,” a new report suggests.

The findings come from United Cerebral Palsy (UCP) and the American Network of Community Options and Resources (ANCOR) Foundation’s “The Case for Inclusion 2023,” a report that examines the state of services for people with IDD and warns that the direct care system is nearing collapse.

UCP President and CEO Armando Contreras and ANCOR CEO Barbara Merrill wrote in a letter introducing the report that “people with IDD are increasingly unable to access the services they need,” with many providers (83%) “turning away new referrals and discontinuing existing services due to a lack of staffing.”

They called for immediate, decisive action “to stem the tide of growing instability,” with the report recommending a series of state and federal policy changes to improve the direct care workforce (which includes certified nursing assistants, home care aides, and others) and access to home- and community-based services—ranging from grant programs to train, recruit, and retain direct support workers to expanding visa opportunities.

Failure to act could force those with IDD to rely on family caregivers, be hospitalized or placed in institutional settings, or even end up homeless, Lydia Dawson, ANCOR’s director of policy, regulatory, and legal analysis, told Healthcare Brew.

“It could mean anything for any individual person based on what’s available to them,” she said. “But it ultimately, in any case, decreases their availability of choice and decreases their ability to experience community integration.”

Keep reading here.—SY

Do you work in healthcare or have information about the industry that we should know? Email Shannon at [email protected]. For completely confidential conversations, ask Shannon for her number on Signal.

We all know that one show-off in college whose favorite prerequisite was, for some reason, organic chemistry II. Luckily, Cardinal Health’s Jerome Revish’s class of choice might be data-related, if he had to pick a course at “Digital U.”

Data, after all, powers many of the advanced gadgets he’s tasked with supporting, as senior VP of digital and commercial technologies at the Ohio-based healthcare services company.

The AI tool CORE, for example, relies on clinical and socioeconomic information to spot at-risk patients. Another American Gladiators-sounding device, VIPER, automatically matches cancer patients to clinical trials.

Cardinal-delivered classes like “A Beginner’s Guide to Data Analytics” exist alongside presentations in data literacy and data strategy—all offerings in the organization’s Digital U.

Created in 2020, the collection of seven “colleges” includes emerging-tech topics that illustrate the changing healthcare environment, like cloud, information security, and analytics.

“In this evolving talent market, it’s important for us to continue to find ways to upskill and rescale. Because [of] the time that it takes, and also the cost that it takes, to go acquire new talent in a demanding market right now, you just can’t get talent fast enough to be able to keep up with competition,” said Revish.

According to Cardinal, at least 6,000 employees have completed the company’s “Digital Fluency” program.

Official intelligence. In its 2023 Tech Trends report, professional-services firm Deloitte noted that many organizations today offer development opportunities like mentoring and rotational programs, “to create fresh talent instead of fighting over a limited supply.”

Keep reading in IT Brew.—BH

Today’s top healthcare reads.

Stat: About 14 million people could be kicked off Medicaid when the pandemic public-health emergency ends. (the Associated Press)

Quote: “I am asking for your help and compassion. Help me, I don’t know what else to do…I CANNOT deal with this stress and fight cancer. You say you are a ministry and want to help people. THEN HELP!!!”—Bonnie Martin, a woman with terminal cancer, wrote in a letter to Liberty HealthShare, a “health care sharing ministry,” or alternative to health insurance (ProPublica)

Read: cAlassified report from the Department of Energy concludes that Covid-19 most likely came from a lab leak in China; the conclusion was reportedly made in “low confidence,” according to people who read the document. (the Wall Street Journal)

Catch up on the top Healthcare Brew stories you may have missed:

• Pediatric allergists struggle to meet growing patient demand
• How 3 companies came to dominate the PBM market
• More docs than ever use health IT for opioid prescribing