Have US health officials learned nothing from COVID?

“I’m not sure why it takes so long, but I can tell you that in the community I serve there is a sense among gay advocacy groups that the FDA is moving slower with a more marginalized population,” 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 this is a growing sensation in the LGBTQ community.”

To be clear, there is no specific evidence that bias has slowed the government response, and the monkeypox virus itself has little in common with COVID – or AIDS. No deaths have been reported from the virus. However, it causes painful skin blisters and fever, and federal agencies need to take it seriously.

The worst part is that the spread of the virus was preventable: unlike the onset of COVID, when the first U.S. case of monkeypox was confirmed in Massachusetts in May, there were already tools available to test, treat and vaccinate against. the virus.

Health experts say CDC and FDA protocols have created unnecessary barriers binding the hands of medical professionals and those at risk of infection to keeping the monkeypox epidemic contained.

“Most of the constraints are imposed by the government,” said Dr Amesh Adalja, an infectious disease expert and professor at the Johns Hopkins Bloomberg School of Public Health.

For example, he pointed to a case where 300,000 doses of the US-owned vaccine remained in a facility in Denmark for weeks while many seeking to be vaccinated in the US were turned down due to insufficient supply, many before and during. the celebrations of Pride in June. The reason? The FDA had not inspected the Danish manufacturing facility. FDA approval of the plant finally came on Wednesday.

“It’s not that the vaccine doses were trapped on an iceberg and no one could reach it,” Adalja said. “The FDA never inspected that plant, so they couldn’t be used even though we knew those vaccines were fine.”

When it is too much, it is too much. The Biden administration must cut red tape and devote all necessary resources to ensure that tests, treatments 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 monkeypox cases reported with 3,800, surpassing Spain this week. This figure, according to health experts including Adalji and Gandhi, is likely to be underestimated.

But according to Gandhi, the ability to contain the virus, which is transmitted through intimate contact but is not a sexually transmitted disease, will be reduced 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 run a “profound risk” of infection. At least two cases have already been reported between children and a pregnant woman. And if the virus hops in the United States in animal reservoirs as it has in other countries – it can be transmitted by rodents, for example – it will be harder to fight.

The federal government must increase the production and distribution of available test protocols that test skin lesions in those with more advanced symptoms and also prioritize the development and FDA approval of test protocols that use saliva and other fluids. body in order to allow for early diagnosis which can, in turn, help prevent spread.

It should remove bureaucratic barriers to off-label use of smallpox antiviral treatments that have been shown to be effective in monkeypox. Although off-label prescriptions are allowed, mountains of regulatory paperwork are usually required to administer, which makes doctors less likely to prescribe. Whether through the FDA’s emergency clearance to treat monkeypox, or through regulatory changes that do away with the red tape doctors have to go through, the federal government must take action to make monkeypox treatment easier.

And federal agencies should prioritize the distribution and administration of vaccinations to those at risk. Wednesday’s announcement that the FDA has approved an additional monkeypox vaccine is good news, but the COVID crisis has taught us that vaccines cannot work without a clear delivery system.

And finally, the CDC must restore its authority and trust by communicating clearly with the American public, and particularly with those within the LGBTQ community, about how to access the tests, treatment and vaccines they need.

The window to keep up with the pandemic and restore the confidence of the American people is closing rapidly. Now is not the time for the Biden administration to kick back.


The editorials represent the views of the Boston Globe Editorial Board. Follow us on Twitter at @GlobeOpinion.

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