WASHINGTON -- Symptomatic of their recent responses to infectious disease outbreaks, federal agencies acted with "a reactive" approach yielding mixed success handling the Zika outbreak. So says a report released by the Government Accountability Office (GAO) Tuesday to coincide with a House subcommittee hearing.
"Emerging infectious diseases have continued to garner global attention," according to a memorandum. "In each of the aforementioned cases, the GAO found that HHS was reactive in its response to outbreak prevention, preparedness, detection, and response."
"Once again, GAO has shown that we were not fully prepared at the outset of the outbreak," Chairman Tim Murphy (R-Pa.) said during the hearing of the Oversight and Investigations subcommittee of the House Energy and Commerce Committee.
"Since Zika virus disease was a newly emerging disease threat in the United States, the Centers for Disease Control and Prevention (CDC), and the states were not fully equipped with needed information and resources at the beginning of the outbreak. This presented several challenges for surveillance and research efforts," the report stated. "While much has been learned about the epidemiology of the Zika virus, many unknowns remain, including the actual number of infections in the United States and the full spectrum of short-term and long-term outcomes."
GAO also found that performance of the 16 Zika diagnostic tests authorized during the outbreak varied. "Without a clear and transparent process for distributing CDC-developed diagnostic tests to manufacturers, the agency may not be able to develop the capacity of the commercial sector to be able to meet the needs during an outbreak," chief scientist Timothy Persons, PhD, wrote in a prepared statement.
Additionally, according to GAO, "Challenges federal agencies identified in supporting (state and local mosquito control) include sustaining staff expertise in mosquito control during periods when there are no outbreaks, funding constraints, and effectively communicating information about the geographical distribution of mosquitoes that transmit the Zika virus."
GAO called on the FDA to consolidate information from diagnostic test labels and via a format that helps users compare information across tests, and should require manufacturers to list the identity of comparator assays on their diagnostic test labels.
In addition, it recommended that the CDC do the following:
- Provide details such as collection records, dates and data limitations on mosquito distribution maps
- Establish a transparent process to provide CDC diagnostic tests to manufacturers in final stages of diagnostic test authorization
- Include information on CDC-developed tests distributed to public health laboratories on its website, including laboratory-developed tests
FDA and CDC agreed with each recommendation, the GAO reported, although CDC only partially supports the last one. ("HHS agreed that it should share information on CDC-developed tests that have received EUA [Emergency Use Authorization]," according to Persons' testimony, but disagreed "with our recommendation that it should share information on CDC's laboratory-developed tests that have not received EUA.")
HHS was diligent but "was nonetheless reactive," Persons said at the hearing. "What's necessary is a more proactive framework."
"This is a marathon," said Anthony Fauci, MD, who directs the National Institute of Allergy and Infectious Diseases.
Fauci cautioned that outbreaks can't be prevented, saying "the trick" is to control it and prevent an epidemic.
GAO interviewed experts and agency officials, and reviewed documents to produce the report.
Rep. Frank Pallone (D-N.J.) distributed a news release Tuesday critiquing potential repercussions for Zika containment stemming from President Trump's budget proposal, which would slash HHS funding by more than 20% and and includes some $800 billion in cuts to the Medicaid program over 10 years.
"This would decimate the Medicaid program and endanger our ability to manage public health emergencies like Zika," Pallone read from his release.
"We must ensure that individuals affected by Zika, particularly pregnant women and children born with microcephaly, have access to ongoing screening and health services ... Medicaid provides contraceptive services to help prevent Zika infection, and diagnostic services to detect infection.
"Fighting Zika will not be easy, but the first step should be to maintain critical health services for those who may be affected and provide agencies with the resources they will need to respond to an outbreak ... It is critical that we give these agencies the tools they need to bolster our (disease) preparedness," he added, saying he was concerned about a hiring freeze at CDC "and that federal support to states for Zika response may be discontinued."
Rep. Kathy Castor (D-Fla.) predicted the federal Zika response would "reach a funding cliff" by September without another governmental action. "The (budget) cuts would come at the exact wrong time," she said.
Another Democrat, Rep. Janice Schakowsky of Illinois, worried that the problems of states paying for needed Zika vaccines "would only be compounded if Medicaid was drastically restructured, as Republicans have called for."
Republicans on the committee defended the proposal to scale back the Medicaid program, but, said Rep. Susan Brooks (R-Ind.), "The issue of Zika is obviously not going away ... we must make sure that we as a government are keeping our citizens safe."