Only a fraction of patients in the United States have been given the drug that is the only cure for monkeypox.
tecovirimat, also known as Tpoxx, is an investigative drug and can't be released from the strategic national stockpile without a series of bureaucratic steps. Most doctors don't have the time to fill out a 27 page application or give detailed patient information.
There is no law that prevents federal officials from changing the rules and making the drug more widely available.
The Food and Drug Administration approved tecovirimat as a smallpox treatment based on safety data in people and efficacy data in monkeys. The agency can approve drugs if they are tested in a way that is unethical.
Until the current outbreak, tecovir was only given to monkeys. It's use against monkeypox is considered experimental. The vaccines for smallpox have been thought to work against both diseases. The treatment should be done.
The F.D.A.'s restrictions can be changed quickly.
According to Larry O. Gostin, an expert on public health law and director of the O'Neill Institute for National and Global Health Law at Georgetown University, the bureaucracy of gaining access to Tpoxx is excessive.
The law allows the agency to use scientific assessments to make sure those in need get the medication they need.
A national health emergency has been declared by the Department of Health and Human Services. The F.D.A. was able to grant emergency use authorizations for vaccines and treatments during the coronaviruses epidemic.
| Total | In Past Two Weeks | Daily Average | 14-day Change |
|---|---|---|---|
| 7,510 | 4,743 | 319 | +82% |
In an article published in the New England Journal of Medicine, federal health officials defended their decision to treat tecoimatvir as an experimental drug.
While acknowledging that animal data was promising and that the drug seemed safe in healthy patients, they wrote that, without large clinical trials, "we will not know whether tecovirimat would benefit, harm or have no effect on people with monkeypox disease."
It's unclear if or how well this drug works for monkeypox patients.
She said that giving Tpoxx only as an experimental drug ensured that they had data from patients who used it. This will help us understand who will benefit the most and what the true benefits are.
Monkeypox is what it is. The symptoms of monkeypox are not as bad as they are for smallpox. There was an outbreak in monkeys kept for research. tens of thousands of men who have sex with men have been affected by the virus, which has spread to dozens of countries since it was first discovered in parts of Central and West Africa. Monkeypox was declared a global health emergency by the World Health Organization.
What does it do? The monkeypox virus can be spread by coughing or sneezing, or by touching items that have previously touched the rash, or by touching items that have not touched the rash. During and after birth, monkeypox can be transmitted from the mother to the fetus.
I'm afraid I might have a disease. I don't know what to do. You can't test for monkeypox if you only have flu symptoms. You can get a monkeypox test from an urgent care center or your primary care doctor. If you have to come in contact with other people for medical care, you should be isolated at home.
I live in the city. Is it possible to get the vaccine? Adult men who have sex with men and have had multiple sexual partners in the last 14 days are eligible for a vaccine in New York City. People with conditions that weaken the immune system or have a history of allergies are encouraged to get the vaccine. There is a website that people can use to book an appointment.
The C.D.C. loosened some of the rules after doctors complained about the restrictions. The system isn't easy to use.
The process of becoming an investigator in a clinical trial is difficult for most doctors, according to the executive director of AIDS ActionBaltimore.
It would make a good bureaucratic joke if this was not a dire emergency. The joke is once again on gay people.
Some patients need to be educated on the process by their doctors due to the complexity of the rules.
Adam Thompson, a cook in Atlanta, first developed a headaches and body pains on July 17 and then two days later had a rash on his face.
He saw a nurse who didn't know how to treat him. He convinced her to prescribe hydrocortisone suppositories and a medication used to treat nerve pain.
They didn't do anything. She told him it would take a long time to get it.
When Mr. Thompson asked her to note in his chart that she was unwilling to prescribe the drug for him, she told him the doctor needed to make a decision. He was finally contacted by the doctor on Sunday, July 31, almost two weeks after he first contacted him.
She said that she had contacted the health department and the C.D.C. He said that he had contacted multiple doctors in different states.
It wasn't important by then. He was on the mend after his wounds healed and the pain went away.
Dr. Lane, the founder and medical director of a network of seven clinics in Pennsylvania and Ohio serving the L.G.B.T. Q. population, said many of her monkeypox patients had been turned away by three or four doctors who couldn't deal with the federal rules
In July, Dr. Lane saw a patient with monkeypox infections that could lead to blindness. The patient had to get an eye exam first before she could get tecovirimat.
It was a Friday afternoon and Dr. Lane didn't want to have the patient wait in a crowded emergency room so she scrambled to find an ophthalmologist instead of waiting to have the exam done at an outpatient office.
Pennsylvania and Ohio have different requirements for a diagnosis.
"This doesn't need to be held back the way it's being held back." As this thing continues to explode, it would be great if we could get the treatment at the local pharmacy.
The drug had been approved by the F.D.A. and had already been shown to be safe in people.
The director of the Cornell Center for Pandemic Prevention said that F.D.A. is not allowed to regulate the practice of medicine.
He said that it was a C.D.C. policy choice to not recommend a drug off-label.
Many people, including Dr. Lane, have reported that tecoimat appears to melt away skin tumors in a day. There have been no reports of serious adverse events.
There is no reason to restrict access to the drug given its effectiveness in patients and the seriousness of the outbreak.
The director of the University of Nebraska's Global Center for Health Security understands that there needs to be more data-gathering. You can do that without creating barriers.
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