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White House again suggests FDA stalling coronavirus vaccine | USA News

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A White House official has continued President Donald Trump’s attacks on the agency that oversees the safety of drug development, suggesting that personnel at the Food and Drug Administration (FDA) have deliberately delayed the development of a vaccine and therapeutics for the coronavirus for political reasons. 

The comments by White House chief of staff Mark Meadows on Sunday came a day after Trump alleged that “deep state” forces, referring to long-serving bureaucrats the president believes are dedicated to undermining his agenda, were slowing the development of vaccines.

The White House has been desperately pushing for a breakthrough in coronavirus vaccines and treatment development as the November election approaches, sparking fears the administration would try to fast track inoculants or therapies not yet proven safe for widespread use. 

Trump was set to hold a news conference to announce an apparent advancement in therapeutics later in the day. 

WHO COVID Debrief on global coronavirus vaccine efforts

“This president is about cutting red tape,” said Meadows on ABC’s This Week programme. 

“He had to make sure that they felt the heat. If they don’t see the light, they need to feel the heat because the American people are suffering,” he said, referencing Trump’s comments about the agency. 

To date, the coronavirus has killed more than 176,000 Americans amid 5.6 million cases. The US is the worst hit, in terms of case numbers and deaths, of any country in the world. 

In recent months, the White House has sunk vast resources into an expedited process to develop a vaccine under operation “Warp Speed”, with Trump aides banking on unveiling a successful vaccine in an “October surprise” that could help the president make up ground before the election. 

“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted on Saturday. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”

Trump, who has been teasing progress in therapeutics for weeks, did not offer any evidence of a slowdown. The White House has also pushed the FDA to step up its approval of blood plasma authorisation.

Meadows did not give specifics during his comments on Sunday, but said “we’ve looked at a number of people that are not being as diligent as they should be in terms of getting to the bottom of it”.

“We really need to make sure that we have good science and the proper protocol,” Meadows said. “But we also can’t wait around and assume that this virus is going to go away. This president wants real results and that’s why he took to Twitter.”

Meanwhile, former FDA commissioner Scott Gottlieb dismissed the suggestion of a slowdown.

“I firmly reject the idea they would slow-walk anything or accelerate anything based on any political consideration or any consideration other than what is best for the public health and a real sense of mission to patients,” Gottlieb told CBS’s Face the Nation programme. 

Expected announcement

On Sunday, White House press secretary Kayleigh McEnany tweeted that Trump, who spent the morning at his Virginia golf course, would make an announcement later in the day on a “major breakthrough on therapeutics” in a news conference and would be joined by Health and Human Services Secretary Alex Azar and Stephen Hahn, the head of the FDA.

Hundreds of drugs are currently being developed as possible treatments for the coronavirus infection, taking a range of approaches.

Many scientists currently believe that among those that offer the most hope are those that administer antibodies to a patient to help the body fight off the virus and stop any illness from progressing. One form of that is convalescent plasma, gathered from people who have already been infected. Another is artificially created monoclonal antibodies.

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Convalescent plasma is already being tried at several hospitals, but there is little data on how effective it is or whether it must be administered fairly early in an illness to make a significant difference, Dr William Schaffner, an infectious diseases expert at Vanderbilt University, told The Associated Press news agency. 

Trump, in press conferences, “has made all kinds of therapeutic suggestions,” which have not proven to be supported by science – and are even dangerous, Schaffner said.

That includes statements about the possible value of treating COVID-19 patients with ultraviolet light and bleach. Trump reportedly also recently became enthusiastic about oleandrin, a plant extract derived from a toxic shrub that scientists immediately warned against.

But the president is perhaps best known for his early and ardent embrace of the malaria drugs hydroxychloroquine and chloroquine. 

The FDA in late March granted emergency authorisation for distribution of the drugs for treating COVID-19. But in June, the agency revoked the authorisation in light of growing evidence they do not work and could cause serious side effects.





Source – www.aljazeera.com

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Another blow as Judge throws out Kiggundu’s lawyer Muwema

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When court sat on Friday to hear the Kiggundu’s application to stop independent audit, he did not have a written application, and Justice Henry Adonyo instead ordered the plaintiff’s lawyer Fred Muwema to go make a written application seeking court to dismiss the audit and return to court on September 30 for a hearing of the application. But this adds more pressure on Kiggundu who is choking with the loans.

On 31 August, the judge ordered the Institute of Certified Public Accountants of Uganda (ICPAU) to carry out and independent audit into the accounts of the businessman and financial statements exchanged between the two parties, and present a report to court.

When asked by journalists why he has filed for an application seeking dismissal of the audit, Fred Muwema had this to say. “We are saying that let the validity and legality of those credit facilities (loans) be decided first before you can audit” He said.

The ruling on the application of the main suit to determine whether the businessman owes loan arrears to the bank is set for 5th October 2020, after which a date for hearing of the case will be set.

Background

Hamis Kiggundu through his companies Ham enterprises and Kiggs International (U) ltd sued DTB branches in Kenya and Uganda for deducting money from his accounts something which the bank contends and said they only acted as per the loan agreement of deducting 30% from Kiggundu’s accounts to recover the credit facilities rendered to him between February 2011 and September 2016

But Court documents filed by the bank in their defense shows that Kiggundu, between February 2011 and September 2016, was granted various credit facilities by the said DTB Banks.

First, via Ham Enterprises Limited, Kiggundu obtained a loan of $6,663,453 and another Sh2.5bn from the DTB (U) to finance his projects in the real estate business.

Later, according to New Vision, he got a facility worth $4.5m through Kiggs International (U) Limited from DTB (K) and mortgaged his properties, which include Plot 328 located at Kawuku on Block 248 Kyadondo, three plots that include 36, 37 and 38 on Folio 1533 Victoria Crescent II situated in Kyadondo and land on Makerere Hill Road on LRV 3716 Folio 10 Plot 923 Block 9.

Documents show that as of January 21, 2020, Kiggundu was in default on payment obligations of $6.298m on the loan facility of $6.663m, as well as sh2.885b on the demand overdraft facility of sh1.5b and the temporary demand overdraft facility of sh1b.

The banks say that Kiggundu was in default on the payment of another $3.662m out of a total loan facility of $4m and another $458,604 on a loan facility of $500,000, as of January 21, 2020.

The DTB consequently served him with a demand notice to either pay up or lose the assets that he submitted as collateral security. The bank threatened to attach a plot on Makerere Hill Road and other prime commercial properties.

Analysts says that Kiggundu’s lawyer is playing delaying tactics aimed at stopping the independent audit as ordered by the court earlier. Kiggundu had wanted court to believe his own audit of loan transactions, but that would amount to injustice to the banks that gave him money-DTB Uganda and DTB Kenya.

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Minister Rukutana charged with attempted murder, remanded

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The state minister for Labour, Gender and Economic Development Mwesigwa Rukutana has been remanded to Kyamugorani prison in Mbarara district.

Rukutana appeared before Ntungamo Grade One magistrate Nazifah Namayanja this afternoon from where he was charged with seven offences related to attempted murder, assault, malicious damage, and threatening violence.

Rukutana was captured in a video that went viral on social media showing him grabbing a gun from one of his bodyguards and started shooting at a vehicle belonging to supporters of his political rival Naome Kabasharira. At the time of the incident, Rukutana had just lost the Rushenyi country NRM flag to Kabasharira.

The prosecution alleges that on September 5, 2020, at Kagugu village in Ntungamo district, Rukutana and others still at large assaulted Julius Niwamanya and threatened to kill or injure him together with three others. The others are Stuart Kamukama, Dan Rwibirungi, and Moses Kamukama. 

It is also alleged that Rukutana also willfully and unlawfully damaged a motor vehicle registration number UAR 840X Toyota Rav 4 type which belongs to Moses Muhumuza.

According to the Judiciary public relations officer, Jameson Karemani, Rukutana has not taken a plea of these charges against him since they can only be tried by the chief magistrate who was not in court today.

As a result, the magistrate decided to send him to Kyamugorani, awaiting his return to court on Tuesday.      





Source – observer.ug

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Lira district headquarters closed over COVID-19

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Lira district headquarters have been closed after one staff tested positive for COVID-19 last week. 

On Monday morning, district staff were blocked at the gate with only the deputy chief administrative officer, his secretary and the receptionist allowed access to their offices. 

Paul Samuel Mbiiwa, the deputy chief administrative officer says that only heads of department will be allowed at the headquarters while the rest will work from home. He adds that the restriction will help to curb the spread of the virus.

“You see corona is not a joke. We have taken a step at fighting it and that is why you are seeing the staff outside. Even in my office here I do not want people to come if there is anything we can discuss on the phone.”

Francis Okello Olwa, a senior community development officer who doubles as the district spokesperson says that the entire district offices will be fumigated and closed for two days.

Health authorities in the district are planning to take samples from all the staff because they could have interacted with the one who tested positive. Currently, there are 19 COVID-19 patients under treatment at Lira regional referral hospital.     

On Sunday four health workers at the hospital tested positive for COVID-19. Dr Patrick Odongo, a senior medical officer at the hospital also succumbed to the virus.  





Source – observer.ug

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