Tag: FDA

Trump calls for anti-malaria drug to be used ‘immediately’ despite caution from top health expert

Donald Trump has called for an anti-malaria drug to be used to treat the coronavirus “immediately”, despite his top health expert having said that evidence for its effectiveness was so far “anecdotal”.

On Saturday morning the president tweeted: “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains – Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents) be put in use IMMEDIATELY. PEOPLE ARE DYING, MOVE FAST, and GOD BLESS EVERYONE! @US_FDA @SteveFDA @CDCgov​ @DHSgov.”

Hydroxychloroquine is an anti-malarial drug while azithromycin is an antibiotic.

Mr Trump had mentioned hydroxychloroquine as a possible treatment on Thursday, before being publicly rebuked by Anthony Fauci, his lead expert in the fight against Covid-19. The coronavirus has infected at least 18,000 people in the US and killed more than 270.

On Thursday the president said: “I do want to say – to me, something so big – the FDA has approved compassionate use for a significant number of patients. We have a drug called chloroquine. A derivation would be hydroxychloroquine, which I hear even better about.

“It’s a common malaria drug. It’s been available, so therefore the safety level we understand very well. It’s been relatively safe. And it showed very encouraging early results. Really encouraging. 

“If we – if this works as well as – hopefully it might. The FDA, which would have taken normally much longer to do under our great Secretary … the head of the FDA has been – Dr Stephen Hahn – he has been fantastic. He got it approved very quickly.  I won’t even tell you how quickly, but let’s put it this way: It’s approved.  And we’re encouraging you to take a look at it. We have ordered a lot of it, and you can too. It’s by prescription.

“It’s a very powerful drug for malaria and also for various forms of very serious arthritis. But we think it has a very serious – a very good impact on what we’re talking about with respect to the virus. So you’ll take a look at that. Then you can coordinate with us. But I think, to me, that’s a game changer.”

But asked about whether the drug was a promising solution, Dr Fauci, director of the National Institute of Allergy and Infectious Diseases, told a White House news conference on Friday that the “the answer is no”.

He said that “the evidence you’re talking about … is anecdotal evidence”

“It was not done in a controlled clinical trial. So you really can’t make any definitive statement about it.”

Dr Fauci told CNN “there’s no magic drug”.

This is not the first time during the coronavirus crisis that the president has clashed with his health experts. Having repeatedly claimed that a vaccine could be developed within months, Dr Fauci and others were forced to stress that it would take at least a year and perhaps longer than 18 months.

[The Independent]

Trump falsely claims drug approval for virus

President Donald Trump misstated the facts Thursday when he asserted that the Food and Drug Administration had just approved a decades-old malaria drug to treat patients infected by the coronavirus. After his FDA chief clarified that the drug still needs testing, Trump also overstated the drug’s potential upside in helping contain the outbreak.

A look at his claims at a news briefing:

TRUMP: “And we’re going to be able to make that drug available almost immediately, and that’s where the FDA has been so great. They — they’ve gone through the approval process. It’s been approved.”

THE FACTS: The drug, known chemically as chloroquine, has been available for decades to treat the mosquito-borne illness malaria. Technically, doctors can already prescribe the drug to patients with COVID-19, a practice known as off-label prescribing. But Trump falsely suggested to reporters that the FDA had just cleared the drug specifically for the viral pandemic spreading in communities across the U.S. That would mean that the drug had met the FDA’s standards for safety and effectiveness.

Minutes later, FDA Commissioner Dr. Stephen Hahn emphasized that the drug still needs testing to determine if it can help patients. He said chloroquine would have to be tested in “a large pragmatic clinical trial to actually gather that information.”

Drug trials typically require hundreds or thousands of patients and, even when accelerated, take weeks or months to complete. In his remarks, Hahn reflected on his background as a cancer doctor and warned against giving patients “false hope” before drugs are fully vetted.

While chloroquine has shown promise in preliminary laboratory studies, some experts are skeptical it will prove effective in human testing.

“I think it could be a game changer, and maybe not,” Trump said, discussing the drug.

But the FDA reiterated in a statement Thursday that there are “no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19.”

___

TRUMP: “If chloroquine or hydroxychloroquine works, or any of the other things that they’re looking at that are not quite as far out … your numbers are going to come down very rapidly.”

THE FACTS: The drugs he is referring to are for treatment in patients already infected. That doesn’t prevent spread of the virus. One study is testing chloroquine to try to protect health care workers at highest risk of infection, because a vaccine is likely a year or more away.

[Associated Press]

Trump Wants to Roll Back Food Safety Regulations

Donald Trump floated rolling back food safety regulations if he wins the White House in November.

In a fact sheet posted online Thursday, the campaign highlighted a number of “specific regulations to be eliminated” under the GOP nominee’s economic plan, including what they called the “FDA Food Police.”

“The FDA Food Police, which dictate how the federal government expects farmers to produce fruits and vegetables and even dictates the nutritional content of dog food,” it read.“The rules govern the soil farmers use, farm and food production hygiene, food packaging, food temperatures and even what animals may roam which fields and when,” the statement continued. “It also greatly increased inspections of food ‘facilities,’ and levies new taxes to pay for this inspection overkill.”

The fact sheet was later removed from the website and a new fact sheet detailing Trump’s economic agenda did not include mention of the FDA.

The FDA recently completed an overhaul of the food safety system with seven rules to better protect consumers from food-borne illnesses. Manufacturers of both animal and human food are now required to implement preventive controls to minimize the risk of contaminating food when it’s manufactured, processed, packed or held by a facility.

Trump’s economic policy plan also calls for “an immediate halt to new federal regulations and a very thorough agency-level review of previous regulations to see which need to be scrapped.”

Agencies would be required to list all regulations and rank them in terms of their contribution to growth, health and safety. The ultimate goal, Trump said, would be to strengthen the rules that are useful and reduce the rules that harm the economy.

(h/t The Hill)

Reality

Republicans can complain about regulations all they want, FDA food regulations on hygiene are part of the reason why when eating food you don’t think twice about if it will kill you.

Who cares what report they manipulate to show regulations kill jobs (overall they don’t) when we are talking about public safety.

Probably the most recent famous incident involving sub-standard sanitary conditions resulting in a public health crisis was the listeriosis outbreak caused by Blue Bell ice cream in 2015 that caused 5 deaths.

These protections are what Trump wants to repeal. This isn’t funny.