No such thing as compassionate use of vaccine

US President Donald Trump had trouble breathing on Oct. 1, 2020. He tested positive for the coronavirus. He was found to have lung infiltrates, which occur when the lungs are inflamed and contain substances such as fluid or bacteria. Their presence indicated an acute case of COVID-19.

That afternoon, White House officials frantically ordered from the biotechnology firm Regeneron Pharmaceuticals the antibody cocktail that helps people infected with the virus fight it off. The cocktail had not been authorized for use by the Food and Drug Administration (FDA).

A lawyer in the White House Counsel’s Office called the FDA commissioner to discuss how the agency could approve the drug’s use for senior administration officials. The lawyer was exploring how Mr. Trump could avail himself of the drug through normal FDA procedures.

The FDA commissioner and other officials, including the top federal drug regulator, worked to clear the drug through a standard process known as an emergency investigational new drug application, often used for very ill patients who agree to take an experimental drug still being tested in clinical trials. Regeneron shipped a package of doses to the White House. Mr. Trump took the drug that night.

Mr. Trump’s condition became so worrisome as his blood oxygen level dipped into the 80s. The disease is considered serious when the blood oxygen level falls to the low 90s. Also, his lungs showed signs of pneumonia caused by the coronavirus. His doctor considered putting him on a ventilator.

The following day he had trouble breathing again and was running a fever. He was twice given oxygen before he had to be taken to the Walter Reed National Military Medical Center. As he was 74 years old and overweight, he was considered a high-risk patient. So he was prescribed an aggressive course of treatment, indicating his condition was serious.

That type of treatment is generally known in the medical field as “compassionate use of medicine.” The term is used for a treatment option that allows the use of medicine or treatment for a patient with an immediately life-threatening condition or serious disease or condition when no comparable product or treatment is available prior to final FDA approval for use in humans.

The compassionate use of the Sinopharm vaccine was how former Philippine Medical Association president Dr. Leo Olarte justified the inoculation of Presidential Security Group (PSG) personnel with the Sinopharm vaccine in October last year.

It will be recalled that in his last public address in 2020, President Duterte surprised the public when he announced, “Almost all soldiers have been inoculated. I have to be frank and I have to tell the truth.” That revelation caught Philippine FDA Director-General Eric Domingo by surprise as at that time no vaccine had been approved by the FDA for use in the country.

When asked in a radio interview who authorized the vaccination, Lt. Gen. Cirilito Sobejana, Commanding General of the Philippine Army, answered, “Our President is our commander-in-chief. I should say it’s from the chain of command of the Armed Forces,” indicating it was authorized by the President himself.

Interior and Local Government Secretary Eduardo Año, who is also vice-chair of the Inter-Agency Task Force on Emerging Infectious Diseases, said, “There’s no need for FDA approval for that. These vaccines have its (sic) EUA (emergency use authorization) in that originating country. If somebody would like to try that for personal consumption, I don’t see any conflict on (sic) the law.”

PSG Commander Brig. Gen. Jesus Durante explained, “We soldiers vaccinated ourselves. It’s so easy. We are soldiers so we have to take risks to accomplish our mission.” He was referring to their mission to protect the life of President Duterte.

When DOBOL B sa News TV hosts Joel Reyes Zobel and Rowena Salvacion asked Dr. Olarte when a doctor can administer medicine not approved by the FDA, the doctor, who is also a lawyer, described three situations that allowed compassionate use of medicine:

1. when the medicine the patient has been taking is not effective;

2. when there is no comparable FDA-approved medicine available;

3. when the condition of the patient is life-threatening.

Asked if the inoculation of PSG men with a vaccine not approved by the FDA falls under any of the circumstances mentioned, Dr. Olarte answered: “Yes, because it was to protect President Duterte from the life-threatening virus.”

But the use of Sinopharm to save the life of President Duterte should not be likened to the compassionate use of drugs to save the life of then US President Trump. Mr. Duterte’s condition was far from life-threatening, unlike Mr. Trump’s condition. And the Sinopharm vaccine was administered to the able-bodied PSG soldiers, not to Mr. Duterte. The Regeneron cocktail was taken by Mr. Trump.

Anyway, last Monday, President Duterte was inoculated with his first dose of Sinopharm COVID-19 vaccine by no less than Dr. Francisco Duque, the Secretary of the Department of Health. The vaccine has yet to be granted an emergency use authorization by the FDA, an agency under the Department of Health.

Presidential Spokesman Harry Roque said the President did not violate any law because China’s Sinopharm vaccine was “covered by compassionate use.” He explained that the President, as Commander-in-Chief of the Armed Forces of the Philippines, is entitled to use these doses. He added that according to Senator Bong Go, the Sinopharm vaccine was prescribed by the President’s physician and it was administered in the PSG Hospital.

But vaccines are designed to prevent disease by training the body’s immune system so that it can fight a disease it has not come into contact with before. That means the recipient of the vaccine is presumed to be free of the disease the vaccine is meant to ward off. The vaccinee is not sick. He needs no compassionate medication or treatment.

So, there is no such thing as compassionate use of a vaccine, Sinopharm or any other brand. There is only the President’s passionate love for anything Chinese.

Oscar P. Lagman, Jr. is a retired corporate executive, business consultant, and management professor. He has been a politicized citizen since his college days in the late 1950s.