Vaccine development process is safe, claims of the contrary are baseless

All of our lives have been drastically impacted by the ongoing coronavirus pandemic — and we know all of us are eager to return to the way things were before the pandemic began. However, that simply won’t be possible without a safe, effective vaccine. Fortunately, due to the strength of American innovation and unprecedented public-private partnerships, a COVID-19 vaccine is on the horizon. We, as the top Republican on the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee and a physician on the Energy and Commerce Health Subcommittee, have been closely following our nation’s progress — and we are confident that we will have a safe, effective vaccine soon.

On July 21, 2020, the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee held a hearing on vaccine development. The subcommittee heard from AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer. All five companies are working on various vaccines and therapeutics for COVID-19 and have received federal funding. Moderna, Pfizer, AstraZeneca, and Johnson & Johnson are all now conducting “phase 3” clinical trials for their COVID-19 vaccine candidates, which is the last stage of testing prior to regulatory approval. AstraZeneca and Johnson & Johnson both recently paused their studies to examine an illness in one of the participants. This is standard protocol, and should give us even more confidence that vaccine companies are following standard safety procedures in their trials — not rushing through the process.

Currently, the Trump administration is working with many pharmaceutical companies to assist in two ways: To advance research and development and to ensure that when a COVID-19 vaccine is approved for safety and efficacy, it is ready to be shipped and distributed across the United States. 

Through “Operation Warp Speed” and the “Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)” partnership, the federal government is doing everything it can to ensure that the private companies developing a vaccine have the resources they need. This assistance is also helping companies to begin establishing manufacturing capability and to initiate the purchasing of necessary raw materials including glass vials for packaging and needles and syringes for the administration of the vaccines. These programs are also facilitating the condensing of the regulatory timeline. For example, the government is currently providing financial support to a number of companies to allow for simultaneous development and production of a vaccine before it receives final approval from the Food and Drug Administration (FDA). Usually, companies will not begin to invest in producing a vaccine or treatment until it has first completed testing and received regulatory approval. We need to ensure that any COVID-19 vaccine is available as soon as it receives the final approval from the FDA.

All five companies assured the subcommittee that any vaccine they produce will meet all safety standards set by the FDA. They also vowed to be transparent about the testing and development process so there are no questions about safety or efficacy.

Many who are working closely on vaccine development are cautiously optimistic that we will

Claims Testosterone for Athlete ‘Offensive’

MANCHESTER—A British Cycling and Team Sky doctor accused of ordering sachets of testosterone has continued to deny that it was for an athlete and once again branded such claims “offensive”.
 
Dr Richard Freeman admits bringing the package of Testogel to the Velodrome in Manchester in May 2011 but claims it was for coach Shane Sutton who bullied him into obtaining it for his erectile dysfunction.

When Mr Sutton appeared at the tribunal, he denied any knowledge of the product being ordered, said he had no problem with erectile dysfunction and branded Dr Freeman a liar.



Riders’ Data

The case continued at the Medical Practitioners Tribunal Service yesterday where Dr Freeman claimed testosterone levels were not an important measurement in athlete’s performance.

But British Cycling and Team Sky have now produced a 111 page bundle of results from riders to assist the case against him.

Representing the General Medical Council, Simon Jackson QC quizzed the doctor with extracts from the book he wrote in 2018 The Line Where Medicine and Sports Collide and an interview he gave to BBC Sports Editor Dan Roan in the aftermath of the publication.

He quoted from the book: “It is about where the lines start and finish” between sport and medicine and asked him if he had ever crossed it.

Dr Freeman replied: “No, I never crossed it.”

He said the title was a “play on words” but reiterated his belief in the WADA code describing it as “completely necessary to provide a level playing field”.

‘Holy Grail’

The tribunal also heard Dr Freeman describe finding out the source of a rider’s under recovery was  the “holy grail”.

He was then asked about testosterone and whether it was an important measurement.

Mr Jackson asked if a normal rate of testosterone in an adult male was between 10 and 35.

Dr Freeman replied: “According to most publications, that is an approximation.”

Mr Jackson then asked: “A healthy testosterone level is very important to maintain the immense work levels riders have to put themselves through?”

Dr Freeman replied: “Correct.”

He was then asked: “So having testosterone down to 3.4, or that level, would be unhealthy and unproductive as a work engine to be an elite competitive rider?”

Dr Freeman said: “There are many hormones involved in health, hormones are affected by calorie restrictions, all sorts of stress… testosterone yes is one of these.”

Mr Jackson asked if injecting testosterone could lead to a quicker recovery.

Dr Freeman said: “I have used the word offensive once before in this tribunal, I find that similar.

“I made a mistake with Mr Sutton, I have never doped a rider, I would never consider it, I would never consider supplementing a rider’s testosterone.”

He went on to claim that athletes would not come to him regularly asking for testosterone levels.

But Mr Jackson pointed to an email involving a patient which made reference to this, saying it had to be looked at.

Dr Freeman said the records he had been handed

Trump claims he’s free of virus, ready for campaign trail

WASHINGTON (AP) — President Donald Trump on Sunday declared he was ready to return to the campaign trail despite unanswered questions about his health on the eve of a Florida rally meant to kick off the stretch run before Election Day.

His impending return comes after the White House doctor said he was no longer at risk of transmitting the coronavirus but did not say explicitly whether Trump had tested negative for it. The president insisted he was now “immune” from the virus, a claim that was impossible to prove and added to the unknowns about the president’s health.

“I’m immune,” Trump said in an interview on Fox News Channel’s “Sunday Morning Futures.” “The president is in very good shape to fight the battles.”

In a memo released Saturday night by the White House, Navy Cmdr. Dr. Sean Conley said Trump met the Centers for Disease Control and Prevention criteria for safely discontinuing isolation and that by “currently recognized standards” he was no longer considered a transmission risk. The memo did not declare Trump had tested negative for the virus.


But sensitive lab tests — like the PCR test cited in the doctor’s statements — detect virus in swab samples taken from the nose and throat. Some medical experts had been skeptical that Trump could be declared free of the risk of transmitting the virus so early in the course of his illness. Just 10 days since an initial diagnosis of infection, there was no way to know for certain that someone was no longer contagious, they said.

His return to full-fledged rallies will be in Florida on Monday, a comeback that comes with the president facing stubborn deficits in the polls. The Trump campaign and White House has not indicated that any additional safety measures will be taken to prevent the transmission of the virus among those traveling on Air Force One, at the event site or at rallies scheduled for Pennsylvania and Iowa later in the week.

Campaign officials have signaled that Trump will be traveling nearly every day the rest of the campaign, and sometimes making more than one stop, an aggressive schedule for a 74-year-old who was hospitalized just days ago.

And with the virus again dominating the national discourse, the Trump campaign has released an ad featuring Dr. Anthony Fauci praising the president’s leadership — but the nation’s leading infectious disease expert on Sunday objected to being included.

“The comments attributed to me without my permission in the GOP campaign ad were taken out of context,” Fauci said in a statement, adding that he was talking broadly about public health officials’ response to the pandemic. “In my five decades of public service, I have never publicly endorsed political candidates.”

Tim Murtaugh, Trump campaign communications director, responded by saying that “these are Dr. Fauci’s own words” and said they were praising the administration’s response.

On Sunday, Trump asserted in a tweet that he had “total and complete sign off from White House Doctors” to fully return

Vice presidential debate: Kamala Harris claims she won’t take vaccine if Trump recommends

Democratic vice presidential candidate Kamala Harris said Wednesday that she would not take a vaccine recommended by President Trump during a heated debate clash over the White House’s response to the coronavirus pandemic.

Harris accused Vice President Mike Pence, head of the Trump administration’s coronavirus task force, of failing to disclose critical information to Americans in the early days of the pandemic. When asked about a poll showing half of Americans would not take a vaccine as soon as it is available, Harris indicated that she was skeptical of Trump’s involvement in the rollout of a potential vaccine.

“If the public health professionals, if Dr. Fauci, if the doctors tell us we should take it, I’ll be the first in line to take it, absolutely,” Harris said. “But if Donald Trump tells us we should take it, I’m not taking it.”

Harris, citing a recent report from Washington Post journalist Bob Woodward, accused the Trump administration of downplaying the severity of the pandemic and bungling its initial response to the novel coronavirus. The California senator said Americans “have had to sacrifice far too much because of the incompetence of this administration.”

Pence fired back at Harris, asserting the Trump administration would have a vaccine “in record time” and potentially by as soon this year. He noted that five U.S. companies were conducting phase three clinical trials of potential vaccines.

WHAT A NEW FOX NEWS NATIONAL POLL SAYS ABOUT THE BIDEN-TRUMP PRESIDENTIAL RACE

“The fact that you continue to undermine public confidence in a vaccine, if a vaccine emerges during the Trump administration, I think is unconscionable, and Senator, I just ask you to stop playing politics with peoples’ lives,” Pence said. “The reality is that we will have a vaccine, we believe, before the end of this year, and it will have capacity to save countless American lives and your continuous undermining of confidence in a vaccine is just unacceptable.”

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‘You catch it and then you get better:’ Trump claims he would’ve beaten COVID-19 without treatment

President Trump boasted Thursday that he doesn’t need any help beating coronavirus — and you don’t either.

The COVID-stricken president said he is strong enough to win his fight against the deadly virus without treatment, an ill-informed statement considering that 210,000 Americans have succumbed to the pandemic

“I think I would have done it fine without drugs. You don’t really need drugs,” Trump told Fox News.

“You catch it and then you get better. And then you are immune,” Trump added.

Trump praised the experimental anti-body treatment that he was given last Friday, calling the drug a “cure” for COVID-19.

But he suggested that his own strength was primarily responsible for his ability to fight off the virus so far.

“I view it as a cure because I took it,” Trump said. “It’s great, it made me better, I’ll tell you right now.”

Doctors say that personal strength obviously has little to do with a person’s ability to fight off coronavirus, which has infected more than 7 million Americans.

Trump also says he doesn’t think he is contagious with coronavirus, even though doctors say COVID-19 patients can still spread the disease for up to two weeks after being infected.

“I don’t think I’m contagious at all,” said Trump, without offering any evidence to back up his claim.

The shocking statements amount to a return to Trump’s default effort to downplay the impact of the pandemic and to undermine efforts to contain the worst public health crisis the U.S. has faced in a century.

After admitting being infected with COVID-19, Trump initially suggested his own illness might cause him to change his tune, saying “I get it now.”

But since his condition has improved, Trump staged a made-for-TV return to the White House and pointedly ripped off his face mask, which protects those around him from contracting the virus from him.

The president now claims to be almost fully recovered, although he admitted taking a powerful steroid, which can mask symptoms and also cause dramatic mood swings.

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Trump claims his Covid treatment means a cure is imminent

“Hi, perhaps you recognize me — it’s your favorite president,” Trump said, one day after being discharged from Walter Reed National Military Medical Center, where he was treated for Covid-19.

“I wasn’t feeling so hot and within a short period of time they gave me Regeneron,” he said, referring to drug company that makes the experimental antibody cocktail he received. “It was unbelievable. I felt good immediately. I felt as good three days ago as I do now.”

Trump later said of the drug, “I call that a cure,” and suggested that his infection was “a blessing from god” that revealed the drug’s promise. “I think if I didn’t catch [the virus] we’d be looking at that like a bunch of other drugs.

The president for months has also been promising that a coronavirus vaccine is imminent, often pledging to make it available by Election Day. Late-stage clinical trials are underway, but no vaccine maker has yet sought emergency authorization or approval from the Food and Drug Administration — and now Trump is focused on the experimental antibody drugs as cures.

He added that his administration would authorize emergency use of Regeneron’s treatment, and a similar antibody drug from Eli Lilly, and would soon make them available to the public. Lilly has said that it is seeking emergency authorization from the Food and Drug Administration, while Regeneron has revealed that it’s in talks with the agency.

“If you’re in the hospital and feeling really bad, I think we’re going to work it so that you get them and you’re going to get them free,” Trump said, adding that the government had “hundreds of thousands of doses that were nearly available.”

The two antibody treatments are now being tested in clinical trials, and scientists have greeted the limited early data released as promising. But the drugs are far from a slam-dunk. Regeneron and Lilly have said that their antibodies help Covid-19 patients clear the coronavirus from their bodies, and appear to speed recovery, but it is not clear whether the drugs reduce the risk of death. Trump has also taken several other medications, including a steroid and the antiviral drug remdesivir.

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Facebook removes Trump’s post with false claims comparing the flu to COVID-19

Facebook on Tuesday removed a post from President Donald Trump that appeared to downplay the severity of COVID-19 by comparing it to the seasonal flu.



a man wearing a suit and tie: President Donald Trump walks to Marine One prior to departure from the South Lawn of the White House, Oct. 2, 2020, as he heads to Walter Reed Military Medical Center, after testing positive for COVID-19.


© Saul Loeb/AFP via Getty Images
President Donald Trump walks to Marine One prior to departure from the South Lawn of the White House, Oct. 2, 2020, as he heads to Walter Reed Military Medical Center, after testing positive for COVID-19.

The same post remains on Twitter, though it has been hit with a label on the platform identifying it as “spreading misleading and potentially harmful information related to COVID-19.”

“Flu season is coming up! Many people every year, sometimes over 100,000, and despite the Vaccine, die from the Flu,” Trump wrote in the twin posts. “Are we going to close down our Country? No, we have learned to live with it, just like we are learning to live with Covid, in most populations far less lethal!!!”

A Facebook spokesperson told ABC News: “We remove incorrect information about the severity of COVID-19, and have now removed this post.”

MORE: Twitter accused of double standard with Trump death wish posts

Trump’s tweet comes just one day after he returned to the White House from the Walter Reed Medical Center where he was treated for COVID-19.



a man wearing a suit and tie talking on a cell phone: President Donald Trump walks to Marine One prior to departure from the South Lawn of the White House, Oct. 2, 2020, as he heads to Walter Reed Military Medical Center, after testing positive for COVID-19.


© Saul Loeb/AFP via Getty Images
President Donald Trump walks to Marine One prior to departure from the South Lawn of the White House, Oct. 2, 2020, as he heads to Walter Reed Military Medical Center, after testing positive for COVID-19.

The U.S. Centers for Disease Control and Prevention states that the flu typically accounts for 12,000 to 61,000 deaths in the U.S. annually since 2010. That number has never risen above 100,000 in any year during that time period. More than 210,000 Americans have died of COVID-19 since March.

Shortly after his Facebook post was removed Tuesday, the president posted again, writing in all-caps: “REPEAL SECTION 230!!!”

His follow-up post refers to Section 230 of the Communications Decency Act, which essentially shields online platforms from liability for content posted on their sites. Trump has previously said Section 230 provides social media behemoths “blanket immunity when they use their power to censor content and silence viewpoints that they dislike.”

This is not the first time Trump has equated the novel coronavirus to the common flu. In a March 9 tweet, the president wrote, “So last year 37,000 Americans died from the common Flu. It averages between 27,000 and 70,000 per year. Nothing is shut down, life & the economy go on. At this moment there are 546 confirmed cases of CoronaVirus, with 22 deaths. Think about that!”

Medical experts have long cautioned equating the seasonal flu to COVID-19, and warned the latter is a much more severe illness.

For one, COVID-19 is a novel virus, meaning much remains unknown about its path, spread and danger. Moreover, COVID-19 remains extremely dangerous because so many people show minimal or no symptoms at onset, which can potentially accelerate person-to-person transmission. The flu also

New guidance to ensure medicine label claims are genuine

The FDA guidance is titled “Providing Regulatory Submissions in Electronic and Non Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.” The focus of the document is to provide guidance for pharmaceutical manufacturers, packers and distributors in relation to promotional materials for human

prescription drugs.

By promotional labeling this generally refers to any labeling, other than the FDA-required labeling, that is devised for promotion of the product and can include TV ads, brochures, booklets, websites and any other source, be that paper-based or digital.

The guidance considers appearance, layout, format, and visible impression of promotional materials submitted, and, in tune with the modern age, embraces everything from the style of a promotional booth to the marketing of medicines through the use of video games.

An example of inaccurate marketing is provided by Forbes. This relates to the company Allergan which produced a new eyelash thickening drug Latisse in 2019, promoted by Brooke Shields. While the marketing material showcased the actor’s longer, thicker lashes from the drug, it was called up by the FDA for not mentioning the possible side effects, which can include “hair growth outside of the treatment area, a permanent darkening of eye color and bacterial infections that can lead to blindness.”

Not only is it important to get marketing material right, it is also of necessary to ensure that fake medicines do not get onto the market.

Concerns with misleading or falsified medicines is a global problem and one which pharmaceutical companies and regulators are seeking to address.

One of the important characteristics, according to the website Healthcare Packaging, is the use of unique identifiers for each item of medicines. This helps with the track and tracing of the product. Such an approach also fits in with the growing interest in technologies like blockchain.

A blockchain is a time-stamped series of immutable record of data that is managed by a cluster of computers not owned by any single entity (this means it is ‘decentralized’).This makes the technology ideal for tracking supplies, and ensuring that required storage conditions have been achieved and that goods have not been tampered with.

READ MORE: Blockchain helps pharma with product traceability

According to a NASDAQ article, the application of blockchain could save the pharmaceutical sector billions of dollars as well as providing a securer supply of medicnes for patients.

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Gov. Cuomo falsely claims New York nursing homes ‘never needed’ to take in Covid-positive patients

New York Gov. Andrew Cuomo said that nursing homes “never needed” to accept Covid-positive patients from hospitals in the state due to a shortage of hospital beds.



Andrew Cuomo wearing a suit and tie: NEW YORK, NY - JULY 23: New York Gov. Andrew Cuomo speaks during the daily media briefing at the Office of the Governor of the State of New York on July 23, 2020 in New York City. The Governor said the state liquor authority has suspended 27 bar and restaurant alcohol licenses for violations of social distancing rules as public officials try to keep the coronavirus outbreak under control. (Photo by Jeenah Moon/Getty Images)


© Jeenah Moon/Getty Images North America/Getty Images
NEW YORK, NY – JULY 23: New York Gov. Andrew Cuomo speaks during the daily media briefing at the Office of the Governor of the State of New York on July 23, 2020 in New York City. The Governor said the state liquor authority has suspended 27 bar and restaurant alcohol licenses for violations of social distancing rules as public officials try to keep the coronavirus outbreak under control. (Photo by Jeenah Moon/Getty Images)

During a press call Wednesday, Finger Lakes News Radio asked Cuomo about his administration’s advisory in late March requiring that nursing homes accept the readmission of patients from hospitals, even if they were positive for Covid-19.

The governor’s office has repeatedly said the advisory was based on federal guidance, which prohibited discrimination based on a coronavirus diagnosis. The state’s Department of Health told CNN, “Residents were admitted to nursing homes during that time not as an overflow facility, but because that’s where they live.”

Cuomo said that the advisory was a precaution if hospitals became overwhelmed — calling it an “anticipatory rule” — which he said didn’t happen.

“We never needed nursing home beds because we always had hospital beds,” Cuomo told Finger Lakes News. “So it just never happened in New York where we needed to say to a nursing home, ‘We need you to take this person even though they’re Covid-positive.’ It never happened.”

Facts First: Cuomo’s assertion that “it never happened” is false. According to a report from the New York State Department of Health, “6,326 COVID-positive residents were admitted to [nursing home] facilities” following Cuomo’s mandate that nursing homes accept the readmission of Covid-positive patients from hospitals. Whether or not this was “needed,” it did in fact happen.

Cuomo’s senior adviser Rich Azzarpodi replied Thursday after publication and took issue with this determination, saying that the governor was specifically referencing the hospital bed shortage. “The governor was crystal clear, he was saying that what did not materialize was the crunch for hospital beds, that every projection especially the federal governments projections predicted was going to happen. That’s what he said never happened. Separately the law has always been that nursing homes could only accept residents that they could adequately care for. None of that has changed.”

On March 25, the state’s Health Department issued an advisory requiring nursing homes to accept “the expedited receipt of residents returning from hospitals” if the patients were deemed medically stable.

“No resident shall be denied re-admission or admission to the [nursing home] solely based on a confirmed or suspected diagnosis of COVID-19,” the advisory stated. “[Nursing homes] are prohibited from requiring a hospitalized resident who is determined medically stable to be tested for COVID-19 prior to admission or readmission.”

This mandate received a great deal of criticism, and Cuomo issued an

Police Probe Pioneering Hip Surgeon Over Bone Hoarding Claims

Police are investigating claims that a renowned surgeon may have kept thousands of bones from patients he operated on.

Derek McMinn, referred to on his website as the ‘father of modern hip resurfacing’, was responsible for a type of surgery that helped former world number one tennis player Sir Andy Murray return to topflight competition.

Mr McMinn has since been suspended from Edgbaston Hospital in Birmingham.

The Independent reported that he allegedly kept the bones of at least 5224 of his patients over a quarter of a century.

Hospital owner, Circle Health Group, said it took the matter “incredibly seriously”.

Investigation Under Human Tissue Law

It is understood that West Mercia Police are investigating an allegation of Breach of Statutory Licensing requirements under the Human Tissue Act 2004. Under the law, it may be an offence to store human tissue for certain purposes without a licence.

The inquiry was launched after referral by the Human Tissue Authority (HTA).

An HTA spokesperson confirmed that it carried out an investigation after concerns were raised by previous hospital owners BMI Healthcare in August 2019, and by the Care Quality Commission following an inspection.

The HTA said its own investigation involved BMI Healthcare staff, as well as Mr McMinn.

The Authority said it was unable to comment further as the matter was now the subject of a police investigation.

The General Medical Council (GMC) said it was “aware of concerns” and had asked BMI Healthcare to send investigation reports and other relevant evidence.

A GMC spokesperson said: “We can and will take action where there is evidence that a doctor poses a risk to patients or public confidence in the profession.”

The GMC confirmed that Mr McMinn was currently registered with a licence to practise.

‘No Stone Unturned’

A spokesperson for Circle Health Group said: “We only acquired the hospital in June and we will leave no stone unturned in investigating these historic issues: they have all been reported to the appropriate authorities and we will co-operate closely with regulators to resolve them.”

The spokesperson confirmed that Mr McMinn’s contract with the Edgbaston hospital had been terminated.

According to Mr McMinn’s website, he graduated from St Thomas’ Hospital in London, and is one of the globe’s leading hip and knee experts, and the inventor of the Birmingham Hip Resurfacing technique.

He has performed more than 3500 hip resurfacings and over 6000 total hip replacements.

He is said to have developed an alternative treatment to hip replacement after seeing poor results in young people.

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