Stephen Hahn Confirmed as FDA Commissioner
The U.S. Senate voted 72−18 to confirm Stephen Hahn, MD, as the FDA’s new commissioner. President Donald Trump nominated Dr. Hahn, an oncologist and chief medical executive at MD Anderson Cancer Center in Houston, to replace Scott Gottlieb, MD, who resigned in the spring.
With this confirmation, Dr. Hahn has become the fourth FDA commissioner in less than a year. After Dr. Gottlieb’s departure in April, Ned Sharpless, MD, stepped in as acting commissioner. Last month, when Dr. Sharpless returned to his previous position as director of the National Cancer Institute (NCI), he was succeeded by acting commissioner Brett Giroir, MD, a top official at the Department of Health and Human Services (HHS).
Prior to the vote, Committee Chairman Lamar Alexander (R-TN) said Dr. Hahn is “exactly the type of nominee” who should lead the FDA, based on his research and management experience. Sen. Patty Murray (D-WA), who voted against the nomination, has concerns about Dr. Hahn’s refusal “to commit to implementing a strong policy to clear nontobacco e-cigarettes” from the market, a measure to help reduce teenage vaping.
Sources: The New York Times, December 12, 2019; The Washington Post, December 3, 2019.
University of Arizona Cancer Center Receives $8.6M NCI Grant to Lead Clinical Trials Network
The National Cancer Institute (NCI) has awarded The University of Arizona (UA) Cancer Center $8.6 million to support the UA Cancer Prevention Clinical Trials Network. Co-leader of the Cancer Center Prevention and Control Program Sherry Chow, PhD, and deputy director of the Cancer Center Julie Bauman, MD, MPH, are co-principal investigators for the 5-year grant.
Under the UA Cancer Center’s leadership, the network brings together 12 affiliated organizations to design and conduct early-phase cancer prevention clinical trials. The network comprises physicians, clinical staff, statisticians, pathologists, data managers, and translational scientists. A primary goal of the UA Cancer Prevention Clinical Trials Network is to identify agents that can be advanced to phase III studies and potentially FDA approval.
“We’ve been very successful in conducting early-phase clinical trials, testing different agents for prevention of lung and upper aerodigestive cancers, HPV-associated cancers, breast, prostate, skin, cervical, and esophageal cancers,” Dr. Chow said. “The new funding will allow us to focus on other prevention concepts, like immunoprevention.”
Source: University of Arizona press release, October 23, 2019.
NIH and Gates Foundation Collaborate to Develop Sickle Cell and HIV Gene Therapies
Over the next 4 years, the National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation will invest more than $200 million to develop gene therapies for sickle cell disease (SCD) and HIV. The organizations also vowed to make these cures affordable and available in limited-resource countries where these diseases are most prevalent.
Gene therapies “are largely inaccessible to most of the world by virtue of the complexity and cost of treatment requirements, which currently limit their administration to hospitals in wealthy countries,” the NIH said in a statement. For example, Spark Therapeutics’ recently FDA-approved gene therapy to treat blindness costs $425,000 per eye, and the cost is similar for chimeric antigen receptor T-cell therapies to treat blood cancers.
Even inexpensive therapies that have shown efficacy in the U.S. are widely unavailable in some low-resource countries. For example, hydroxyurea has barely been studied in sub-Saharan Africa, one of the areas hit hardest by the disease.
The collaboration hopes to move gene therapies into clinical trials in the U.S. and sub-Saharan Africa within the next decade, eventually improving access and affordability in areas with high concentrations of patients with SCD and HIV.
Source: STAT, October 23, 2019.
California Launches $15 Million Sickle Cell Initiative
California has launched a new initiative to support adults with sickle cell disease (SCD) by establishing a network of clinics across the state and expanding services for this population. Democrats Governor Gavin Newsom and California Assemblymember Mike Gipson committed $15 million in funding to the initiative.
The launch coincides with the grand opening of a new clinic site at the Martin Luther King Jr. Outpatient Center in Los Angeles, named for Jeffrey Smith, who died from complications related to SCD at age 23 in 1982.
A statewide network of regional clinics will be modeled after the Martin Luther King Jr. center, focusing on areas with the largest concentrations of adults living with SCD. The funding also will promote workforce development to strengthen clinicians’ understanding of SCD treatment guidelines, expand outreach and education, and improve tracking to better monitor care and outcomes through a partnership with the Sickle Cell Data Collection Program.
“We have waited too long to address the poor health outcomes and premature deaths suffered by individuals with sickle cell disease in California,” said Diane Nugent, MD, president and medical director of the Center for Inherited Blood Disorders. “The program made possible by this funding … will give new hope to and extend the lives of our vulnerable and underserved Californians who suffer from this terrible disease.”
Source: Center for Inherited Blood Disorders press release, November 25, 2019.
Beth Shaz Begins New Role as AABB President
AABB (formerly known as the American Association of Blood Banks) inaugurated Beth Shaz, MD, as its new president at the 2019 AABB Annual Meeting. She succeeds Mike Murphy, MD, in this role. Dr. Shaz also serves as executive vice president and chief medical and scientific officer at the New York Blood Center.
“I have been a proud and actively involved AABB member since my transfusion medicine fellowship,” she said. As president, Dr. Shaz will be responsible for implementing AABB’s new strategic plan and mission to advance donor safety and patient care, which also was unveiled at the organization’s annual meeting.
Source: AABB press release, October 22, 2019.