President Donald Trump’s special remedy for access to an experimental COVID-19 drug raises equity issues that begin with the flawed health care formula suffered by many Americans and end with the public’s right to be more informed about their condition, according to medical experts.
Regeneron Pharmaceuticals Inc. revealed on Tuesday how rare it is for someone to get the drug he gave Trump outdoors from studies that prove his protection and effectiveness. The drug, which provides antibodies to help the immune formula coronavirus, is widely considered to be very promising.
Trump also received the antiviral remdesivir and the steroid dexamethasone, and it’s to know if any of those drugs have done him any good.
“He deserves a special remedy in his office,” said George Annas, who directs the Center for Health Law and Ethics at Boston University. “The question is whether this is a smart remedy. “
These drugs have not been shown for benign diseases and have not been tested in combination. The steroid turns out to contradict medical rules based on what doctors have said about the severity of their disease.
“The public is getting combined messages about his condition and that’s a problem,” Annas said, adding that there is a right to know anything Trump’s ability to do his job.
HOW HE TOOK THE DRUGS
Trump doctors requested the drug Regeneron under the rules of “compassionate use,” which allow a patient with a life-threatening illness to download an experimental drug if they enroll in an exam that tests it and there is no smart alternative.
Trump won the drug at the White House on Friday before being taken to Walter Reed National Military Medical Center. Walter Reed is not a site where the drug is tested, so he would possibly have met this criterion for technical reasons. In one study, you would have risked being randomly assigned to a comparison organization that received the same care as always as when receiving the drug.
Requests for compassionate use are on a case-by-case basis, and the U. S. Pharmaceutical Company and the U. S. Food and Drug Administration will have to agree. An FDA spokeswoman declined to comment on the FDA’s ruling or say how many others have ordered the drug.
WHAT IS THE SPECIALTY?
Fewer than 10 of those applications have been granted, Regeneron spokeswoman Alexandra Bowie said. The drug is limited in quantity, the priority is to use it for ongoing studies and the emergency is granted “only in rare and exceptional circumstances,” he wrote in an email. .
Regeneron also contacted Democratic presidential candidate Joe Biden’s crusade “to make them aware of the compassionate use mechanism, if they have to apply” if Biden is infected, Bowie wrote. “There is no promise of access to drugs,” he added.
Alison Bateman-House, ethics specialist at NYU Langone Health, said there were considerations about Regeneron’s opening to Biden.
“This is opposed to the appearance of selling a potentially uns selected product” in violation of FDA rules, he said. Instead of encouraging others to enroll in studies, he suggests, “Call us and we cut the line for you,” he said.
As for Trump, “it’s not clear to me that this is an emergency,” said Dr. Steven Joffe, director of medical ethics at the University of Pennsylvania.
“I think there’s something wrong with privilege, the president, who’s getting a special remedy that can’t be given to the rest of us,” he said. “There is so much injustice in our fitness care system, with so many other people not even having access to the basics,” that the favoritism shown toward Trump is “a symptom of a much bigger problem. “
Trump spent three nights in an army hospital with a group of doctors who monitored him 24 hours a day and at the White House.
WHAT ARE YOU SICK OF?
Trump’s doctor eluded questions about trump’s main points of illness and cited fitness confidentiality rules. He continually described Trump’s symptoms as mild and said he had been given oxygen twice but was not breathless. The steroid trump was given is for hospitalized patients only. patients who want additional oxygen: Studies recommend that it may be destructive in less sick patients.
“In fact, we get a very clear picture. There are facets of history that just don’t seem to happen together,” Joffe said.
“The White House has a legal responsibility to provide other Americans with a transparent picture of the physical condition of the commander-in-chief in a physical fitness crisis,” even if he keeps the main points, such as his instant important signals, express, perhaps at Trump’s request, he said.
Trump’s medical team “did not assume their ethical duty to the American public” to be fair and open about their health, Bateman-House said. “You give up much of your privacy when you’re president. “
Finally, some are dismayed that Trump has gained special attention by posting public fitness recommendations on dressing in a mask and other measures to curb the spread of the virus.
“He has a legal responsibility to adhere to U. S. regulations and has a legal responsibility to set an example,” he said. “We have disorders at any of those points. “
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Marilynn Marchione can be on Twitter at http://twitter. com/MMarchioneAP
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The Associated Press Department of Health and Science is supported by the Department of Scientific Education at Howard Hughes Medical Institute. The AP is for all content only.