The sluggish federal response to the monkeypox outbreak is dangerous not only to those most vulnerable to infection by the virus. It also poses a grave risk to the already battered reputations of the Centers for Disease Control and Prevention, Food and Drug Administration, and other federal health agencies, which have already seen the erosion of the trust of many Americans during the COVID-19 pandemic.
This time, the slow federal response is causing the community hit hardest by the outbreak, which has spread predominately among gay and bisexual men and transgender and nonbinary people, to have flashbacks not only to COVID-19 mishaps, but also the early days of the AIDS epidemic.
“I’m not sure why it is taking so long, but I can tell you in the community in which I serve there is a feeling among gay advocacy groups that the FDA is moving more slowly with a population that is more marginalized,” said Dr. Monica Gandhi, professor of medicine and associate division chief of HIV, Infectious Diseases, and Global Medicine at UCSF/San Francisco General Hospital. “I hope that’s not true, but that is a growing feeling in the LGBTQ community.”
To be clear, there’s no specific evidence that bias has slowed the government’s response, and the monkeypox virus itself has little in common with COVID — or AIDS. No deaths from the virus have been reported. It does cause painful skin blisters and fever, though, and federal agencies have to take it seriously.
The worst part is that the spread of the virus was preventable: Unlike at the beginning of COVID, when the first US case of monkeypox was confirmed in Massachusetts in May there were already tools available to test for, treat, and vaccinate against the virus.
Health experts say CDC and FDA protocols have created unnecessary barriers that tie the hands of medical professionals and those at risk of infection from keeping the monkeypox outbreak contained.
“Most of the constraints are government-imposed constraints,” said Dr. Amesh Adalja, an infectious disease expert and professor at the Johns Hopkins Bloomberg School of Public Health.
By example, he pointed to an instance where 300,000 US-owned vaccine doses sat in a Denmark facility for weeks while many seeking to be vaccinated in the United States were turned away due to insufficient supply, many before and during Pride celebrations in June. The reason? The FDA had failed to inspect the Danish manufacturing plant. FDA clearance of the plant finally came Wednesday.
“It’s not like the vaccine doses were trapped on an iceberg and no one could get to it, Adalja said “The FDA never inspected that plant, so they couldn’t be used even though we knew those vaccines are fine.”
Enough is enough. The Biden administration must cut the bureaucratic red tape and devote all necessary resources to ensure that testing, treatment, and vaccines are available to every person who needs them.
The window to contain the virus is closing. The United States now leads the world in reported monkeypox cases with 3,800, surpassing Spain this week. That figure, according to health experts including Adalji and Gandhi, is likely to be underreported.
But according to Gandhi, the ability to contain the virus, which is passed via intimate contact but is not a sexually transmitted disease, will be curtailed if it spreads more rapidly within the general population. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said children and pregnant women face a “profound risk” of infection. There have already been at least two reported cases in children and one pregnant woman. And if the virus jumps in the United States to animal reservoirs as it has in other countries — it can be passed by rodents, for example — it will be harder to combat.
The federal government must ramp up production and distribution of available testing protocols that test skin lesions in those with more advanced symptoms, and also prioritize the development and FDA approval of testing protocols that use saliva and other bodily fluids in order to allow earlier diagnosis that can, in turn, help prevent the spread.
It should eliminate the bureaucratic barriers to the off-label use of smallpox antiviral treatments that have proven effective in monkeypox. While off-label prescriptions are allowed, it usually requires mountains of regulatory paperwork to administer, which makes doctors less likely to prescribe. Whether through emergency FDA authorization for monkeypox treatment, or by regulatory changes that eliminate the red tape doctors must wade through, the federal government must act to make monkeypox treatment easier.
And federal agencies should prioritize vaccination distribution and administration to those at risk. Wednesday’s announcement that the FDA has approved an additional monkeypox vaccine is welcome news, but the COVID crisis taught us that vaccines can’t work without a clear system of administration.
And finally, the CDC must reestablish its authority and trust by communicating clearly with the American public, and specifically those within the LGBTQ community, about how to access the testing, treatment, and vaccines they need.
The window to stay ahead of the pandemic, and restore the trust of the American people, is closing fast. This is no time for the Biden administration to drag its feet.
Editorials represent the views of the Boston Globe Editorial Board. Follow us on Twitter at @GlobeOpinion.
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Published on The Perfect Enemy at https://bit.ly/3bmm4nh.
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