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Trump sparks new FDA concerns with praise of ‘miracle’ treatment

President Trump’s public praise for an experimental coronavirus antibody treatment is putting new pressure on the Food and Drug Administration (FDA) to quickly give emergency clearance to a drug he has touted as a “miracle.”

a person sitting on a table: Trump sparks new FDA concerns with praise of 'miracle' treatment

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Trump sparks new FDA concerns with praise of ‘miracle’ treatment

Doctors think the drugs show promise as a potential treatment of COVID-19, though Trump has created confusion by quickly elevating them to a cure.

“They call them therapeutic, but to me it wasn’t therapeutic,” Trump said in a video he tweeted on Wednesday, five days after receiving the experimental treatment from the biotech company Regeneron.

Trump said that he felt better immediately after taking the drugs.

“I call that a cure,” he said. “It’s a cure.”

But by placing himself in the middle of the drug evaluation process, Trump is once again igniting concerns that politics is encroaching on science at a crucial time.

The pressure threatens to undermine confidence in government regulators and turn the science of drug evaluation into yet another political dispute, confusing Americans and sowing distrust about helpful therapies.

Former FDA Commissioner Scott Gottlieb said the agency should grant emergency authorization to antibody treatments like the one Trump took, and people shouldn’t be so quick to attack such a promising therapy.

“I hope people don’t shoot at these drugs because there’s this political veneer over access to this. We should just look at the scientific merits,” Gottlieb said Friday on CNBC.

Gottlieb also said the safety bar for antibody treatments is lower than it is for vaccines because the science for antibodies is better understood.

“These drugs, based on the data we’ve seen publicly, probably meet the bar for an emergency use authorization. They’re different from a vaccine, a vaccine you’re going to have a much higher threshold for safety,” Gottlieb said.

Two companies have filed for emergency use authorization for antibody drugs in the past week: Regeneron and Eli Lilly. The treatment from Eli Lilly consists of a single monoclonal antibody, while the treatment from Regeneron consists of a cocktail of antibodies.

Monoclonal antibodies are lab-generated versions of one of the human body’s main defenses against pathogens.

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Doctors and health experts think antibody drugs could be a bridge to a COVID-19 vaccine, but have cautioned that the results to date are very preliminary and longer studies are needed.

“I think there’s an efficacy signal here. But it’s a very selective part of the patient population,” said Jesse Goodman, a professor at Georgetown University who was FDA’s chief scientific officer during the Obama administration.

Regeneron issued a press release touting its preliminary results, but has not publicly released any data. According to the company, a high dose of its drug led to reduced levels of the virus in non-hospitalized patients with mild to moderate symptoms.

Eli Lilly’s submission was based on studies showing that its antibody

Trump’s “miracle” COVID-19 treatment was developed using cells derived from an aborted fetus: report

Donald Trump
Donald Trump

U.S. President Donald Trump leaves the White House for Walter Reed National Military Medical Center on the South Lawn of the White House on October 2, 2020 in Washington, DC. President Donald Trump and First Lady Melania Trump have both tested positive for coronavirus. Drew Angerer/Getty Images

President Donald Trump has not been shy in his praise for the experimental COVID-19 treatments he received after testing positive last week. In videos posted to Twitter, the president has falsely hailed the therapeutics as “cures” and “miracles coming down from God.”

One of the treatments made available to Trump would have been defeated by his own efforts to thwart the scientific research that made it possible: fetal cell tissue from abortions.

According to Trump’s personal physician, Dr. Sean Conley, the president received a high-dose infusion of monoclonal antibodies last Friday as part of his treatment for COVID-19 infection. Trump was one of the first 10 patients who received the treatment under “compassionate use” emergency access, Salon earlier reported. Several hours after the injection, the president was flown to Walter Reed Medical Center.

The fully-human antibody molecules, made by the pharmaceutical company Regeneron, come from two sources: antibodies identified from humans who have recovered from COVID-19 and the company’s “VelocImmune” mice, which have been genetically modified to have a human immune system, according to a statement provided to Salon by the drug manufacturer.

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The lab tests used to evaluate the effectiveness of the antibodies were derived from what the MIT Technology Review pointed out was a standard cell supply known as HEK 293T. It originated as kidney tissue derived from an abortion in the Netherlands in 1973, the same year Roe v. Wade was decided.

Those cells have since been “immortalized” in labs — they keep dividing endlessly, similar to cancerous growth — and have gone through other genetic changes, according to MIT. Over such a length of time, they can become disassociated from their origin.

“It’s how you want to parse it,” a Regeneron spokesperson told MIT. “But the 293T cell lines available today are not considered fetal tissue, and we did not otherwise use fetal tissue.”

But the line connecting the cell lines remains unbroken. The president undeniably benefited medically from cells originating from aborted fetuses.

Regeneron told MIT that other labs also use 293T cells to make what it describes as “pseudoparticles,” or virus-like bodies which have the coronavirus’ “spike” protein. Those particles are necessary in order to test how different antibodies work against the virus. Both antibodies in Regeneron’s treatment would have gone through those tests, MIT reported.

The Trump administration has restricted medical research using fetal tissue from abortions. In 2019, Trump himself overrode top administration scientists, such as Secretary of Health and Human Services (HHS) Alex Azar, and tightened the reins on the National Institutes of Health (NIH) to fund such research. It was an effort pushed by Vice President Mike Pence in an apparent appeal to religious conservative voters.