Under the agreement, AZ will develop, manufacture and distribute the vaccine that has already begun Phase I trials.

Menarini adds Stemlineâs lead product, Elzonris, and its presence in the US with buyout deal.

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading →

On February 21 I published a piece on LinkedIn – Communications Considerations for Medical Manufacturers as the COVID-19 Epidemic Emerges – that provided an overview of some of the communications considerations for pharma, biotech and device manufacturers related to the … Continue reading →

Virtually everyone is going virtual. Even in February, which seems like a very long time ago, many organizers began either postponing or canceling major conferences and meetings. This has included major medical meetings and given that large gatherings will be … Continue reading →

Posted by Reed Beall and Amir Attaran (respectively Phd Candidate and Professor, University of Ottawa) In 2005, the FDA launched an investigation into pharmaceuticals bought from “Canadian” internet pharmacies online and shipped to US consumers. Of 1700 packages these pharmacies supplied, fully 85 percent of those actually came from somewhere else, but 15 percent really came from Canada.  Worse, 32 of the drugs were found to be counterfeit.  All of these pacakges were ente [...]

by Derek Willis

In an April report that warns of the risks of fraud in mail-in voting, a conservative legal group significantly inflated a key statistic, a ProPublica analysis found. The Public Interest Legal Foundation reported that more than 1 million ballots sent out to voters in 2018 were returned as undeliverable. Taken at face value, that would represent a 91% increase over the number of undeliverable mail ballots in 2016, a sign that a vote-by-mail system would be a “catastrophe” for elections, the group argued.

However, after ProPublica provided evidence to PILF that it had in fact doubled the official government numbers, the organization corrected its figure. The number of undeliverable mail ballots dropped slightly from 2016 to 2018.

The PILF report said that one in five mail ballots issued between 2012 and 2018, a total of 28.3 million, were not returned by voters and were “missing,” which, according to the organization, creates an opportunity for fraud. In a May 1 tweet that included a link to coverage of the report, President Donald Trump wrote: “Don’t allow RIGGED ELECTIONS.”

PILF regularly sues state and local election officials to force them to purge some voters from registration rolls, including those it claims have duplicate registrations from another state or who are dead. It is headed by J. Christian Adams, a former Justice Department attorney who was a member of the Trump administration’s disbanded commission on election integrity.

The report describes as “missing” all mail ballots that were delivered to a valid address but not returned to be counted. In a statement accompanying the report, Adams said that unaccounted-for ballots “represent 28 million opportunities for someone to cheat.” In particular, the organization argues that the number of unreturned ballots would grow if more states adopt voting by mail.

Experts who study voting and use the same data PILF used in the report, which is from the Election Administration and Voting Survey produced by the federal Election Assistance Commission, say that it’s wrong to describe unreturned ballots as missing.

“Election officials ‘know’ what happened to those ballots,” said Paul Gronke, a professor at Reed College, who is the director of the Early Voting Information Center, a research group based there. “They were received by eligible citizens and not filled out. Where are they now? Most likely, in landfills,” Gronke said by email.

A recent RealClear Politics article based on the PILF report suggested that an increase in voting by mail this year could make the kind of fraud uncovered in North Carolina’s 9th Congressional District in 2018 more likely. In that case, a political consultant to a Republican candidate was indicted on charges of absentee ballot fraud for overseeing a paid ballot collection operation. “The potential to affect elections by chasing down unused mail-in ballots and make sure they get counted — using methods that may or may not be legal — is great,” the article argues.

PILF’s report was mentioned in other news outlets including the Grand Junction Sentinel in Colorado, “PBS NewsHour” and the New York Post. The Washington Times repeated the inaccurate claim of 1 million undeliverable mail ballots.

In a statement, the National Vote at Home Institute, an advocacy group, challenged the characterization of the 28.3 million ballots as missing. Of those ballots, 12 million were mailed by election officials in Colorado, Oregon and Washington, which by law send a mail-in ballot to every registered voter, roughly 30% of which are not returned for any given election. “Conflating voters choosing not to cast their ballots with ‘missing’ ballots is a fundamental flaw,” the statement reads.

In an interview, Logan Churchwell, the communications director for PILF, acknowledged the error in the number of undelivered ballots, but defended the report’s conclusions, saying that it showed potential vulnerabilities in the voting system. “Election officials send these ballots out in the mail, and for them to say ‘I have no idea what happened after that’ speaks more to the investments they haven’t made to track them,” he said in a telephone interview.

But 36 states have adopted processes where voters and local officials can track the status of mail ballots through delivery, much like they can track packages delivered to a home. Churchwell said there are other explanations why mail ballots are not returned and that state and local election officials could report more information about the status of mail ballots. “If you know a ballot got to a house, you can credibly say that ballot’s status is not unknown,” he said.

The EAVS data has been published after every general election since 2004, although not every local jurisdiction provides complete responses to its questions.

In the data, election officials are asked to provide the number of mail ballots sent to voters, the number returned to be counted and the number of ballots returned as undeliverable by the U.S. Postal Service, which provides specific ballot-tracking services. The survey also asks for the number of ballots that are turned in or invalidated by voters who chose to cast their ballots in person. It asks officials to report the number of ballots that do not fit into any of those categories, or are “otherwise unable to be tracked by your office.”

Gronke described the last category as “a placeholder for elections officials to put numbers so that the whole column adds up,” and said that there was no evidence to support calling those ballots a pathway to large-scale voter fraud.

Numerous academic studies have shown that cases of voter fraud are extremely rare, although they do occur, and that fraud in mail voting seems to occur more often than with in-person voting.

by Alice Wilder, WNYC

Presidential lawyer and former New York City Mayor Rudy Giuliani has largely fallen out of the public eye since his starring role in President Donald Trump’s impeachment. But Giuliani hasn’t gone silent.

Instead, he’s in his home, doing a call-in radio show and a podcast — “Common Sense” — during which he has repeatedly gone on bigoted rants about China and its government.

“They have no morals,” he said on his April 28 radio show. “They’re amoral in the sense that human life means something in Western civilization, it means a lot. Human life doesn’t mean the same thing to them.”

Giuliani has also speculated that the spread of the coronavirus may be a plot by the Chinese government.

For example, Giuliani has raised the possibility that China purposely released the virus from a biological lab in Wuhan. “We have to say accidentally,” Giuliani said in a recent radio broadcast. “But I don’t think as responsible investigators we can rule out that it wasn’t done deliberately.”

Experts say there’s no public evidence the virus came from the lab. Amid a reported White House push, U.S. intelligence agencies have said they are investigating the origins of the virus.

Giuliani is also fixated on the idea that the Chinese government sent sick people overseas. In an April 27 episode of his podcast, he said that China allowed “over a million people from Wuhan travel to us, to the United States, to England to France to Italy to Germany.” He added, “I hope the people there have the same reaction we have to the value of human life and the loss of human life.”

“When they found out about this terrible virus that escaped, assuming they didn’t do it on purpose,” Giuliani said a day later on his radio show, “they were going to make sure the West suffered as much if not more than they did and jumped on top of an opportunity, it’s not a big assumption to make. And there isn’t a contrary explanation.”

The New York Times found that thousands, not millions, of people flew internationally out of Wuhan.

Asked about his comments, Giuliani did not respond.

The comments by Giuliani have come as discrimination against Asian Americans has spiked. And they reinforce the White House’s emerging push to blame China for the pandemic.

Giuliani has said he’s spoken to the president a number of times about the coronavirus. Two days after Giuliani said he was sure the virus came from the Wuhan lab, Trump said he has evidence of the same. (The president declined to give the evidence, saying it’s secret.)

Giuliani appears to have found a receptive wider audience too. An advertising executive at 77 WABC, which airs Giuliani’s radio show, said “feedback has been amazing” and online listening has “skyrocketed.”

The station’s parent company, Red Apple Media, did not respond to a request for comment.

In an April 23 radio show, Giuliani interviewed Gordon Chang, a conservative pundit who frequently predicts the collapse of the Chinese government. Chang said if China released the virus accidentally — for which, again, there’s no evidence — it then decided to create a global pandemic. “I think what Xi Jinping did was he decided he was going to spread the virus so that he would level the playing field so that China would not be in such a hole,” Chang said, referring to China’s president.

“Wow,” Giuliani responded. “So he saw an opportunity, if that theory is correct, and it wasn’t a bioweapon to start with, he saw an opportunity that was sort of accidentally presented to him, and then he took advantage of it. It was opportunistic.”

Chang acknowledged, “We can’t know what was in Xi Jinping’s mind for sure.” But then he went on, “It looks more like they were deliberate and malicious and that means Mr. Mayor ... this is a crime against all of humanity.”

Giuliani ended the interview by inviting Chang to be a guest on his other show, the podcast.

Giuliani has also said he’d use his access to help guests on his show move ahead with exploratory treatments. Talking with one pharmaceutical executive on his show in late March, Giuliani told his guest, “I’ll use whatever my yelling and screaming can do to do it faster, to help you.”

As the Times reported, the executive’s company received initial trial approval from the Food and Drug Administration soon after. (The FDA has said the application was subject to “internal scientific review.” And Giuliani has said he has no business connection to the company.)

“I don’t lobby the government,” Giuliani emailed in response to a request for comment. “I do hope, however, that they and others are successful.”

Giuliani appears to have strong feelings about the government’s process for approving drugs.

In an April 23 broadcast, Mark, a pharmacist from New Jersey, called in to report on his “informal study” of the patients who have used a drug cocktail that includes hydroxychloroquine — the anti-malaria drug that Trump long has touted.

Giuliani was excited when Mark reported that none of his patients had been hospitalized: “Why doesn’t this count with all these geniuses in Washington? The double blind study and the triple blind study and this study and that study, we don’t have time for that, we’ve got to go to people like Mark in New Jersey!”

In fact, the FDA has warned against widespread use of the drug, noting that it can cause heart problems.

The discussions with his listeners, though, often come back to China.

One caller to Giuliani’s radio show, identifying himself as “George from Bay Ridge,” went on a rant against Chinese people, likening them to serial killers with “no conscience” who are attempting to take over businesses all over the world.

Giuliani responded, “George, I’ve been getting complaints about this for a long time.” He added: “It almost reminds me of the Mafia. You know, they say, if you do business with America it’s one thing. If you do business with China you don’t realize, all of a sudden you start owing them too much and they believe they own you.”

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by Joaquin Sapien

New York Attorney General Letitia James is looking into allegations that a Queens adult care facility has failed to protect residents from the deadly coronavirus and misled families about its spread, according to two lawmakers who asked for the inquiry and a relative of a resident who spoke to an investigator with the attorney general’s office.

In a separate action Tuesday, three residents of the Queens Adult Care Center sued the facility in federal court over similar allegations.

Both developments were prompted largely by ProPublica’s recent coverage of the facility, which houses both frail elderly residents and those with mental health issues. On April 2, we reported that workers and residents at the home were becoming ill with the coronavirus as residents wandered in and out of the home without any personal protective equipment. Family members later told ProPublica the management said no residents were sick with the virus at the time.

On April 25, ProPublica published a story and a short film with the PBS series Frontline about the harrowing experience of Natasha Roland, who rescued her father in the middle of the night as he suffered coronavirus symptoms so severe he could barely breathe. Roland, in heart-wrenching detail, described how the management of the Queens Adult Care Center repeatedly assured her that her 82-year-old father, Willie Roland, was safe, even as the virus swept through the facility. She said workers were too scared to care for him, forcing his girlfriend, Annetta King-Simpson, to do so. King-Simpson later fell ill herself. Roland and King-Simpson are now suing the facility in federal court.

In an interview, Assemblywoman Catalina Cruz, whose district covers Corona, Elmhurst and Jackson Heights, said she was troubled by what ProPublica reported. She said she hoped the attorney general can determine whether the Queens Adult Care Center had broken any laws.

“It didn’t sit right with me. I thought something was off here. So I said let’s have the experts look at whether there was a crime or a civil violation,” she said. “Folks who live in this adult home deserve the same dignity as everyone else, and if their rights have been violated, someone needs to pay for that.”

Cruz said she had been suspicious of the facility for several years and had come across a community Facebook page where people posted complaints about treatment of residents at the center. When she saw the ProPublica stories, she said she decided to take action, along with City Council member Daniel Dromm, who had already written to the New York State Department of Health and the office of Gov. Andrew Cuomo about the spread of the coronavirus in the facility on several occasions.

“The plight of those living in adult care centers during this crisis was highlighted in a recent article published by ProPublica, which focused on the perils faced by the residents at the Queens Adult Day Care Center,” the lawmakers wrote in their April 27 letter to the attorney general and the governor’s office. “Failure to inform families about the health of loved ones, to lying and covering up deaths have become regular concerns we have received. We are aware that adult care centers are struggling to keep COVID-19 from affecting their residents and we also know that minorities have been disproportionately affected by the virus. It seems to us that management at this particular center have struggled to implement procedures and policies to protect the lives of its residents.”

Cruz said she received an update from the attorney general’s office on May 5, saying it was looking into the matter but would not provide specific details.

Days after the lawmakers sent the letter, Natasha Roland, 35, said she received a phone call from an investigator with the attorney general’s office. Roland said she recapped what she had previously told ProPublica: She began to worry about her father’s safety when nearby Elmhurst Hospital became a viral hot spot, but the management repeatedly told her there were no coronavirus cases in the facility. She said she only found out the truth weeks later when a worker she was friendly with advised her to come and pick up her father because the virus was raging through the facility and aides were becoming too scared to check on residents. In a subsequent interview, that worker denied telling Roland to pick up her dad.

A spokesperson for the attorney general would not confirm or deny a specific, active investigation into the Queens Adult Care Center, but said James has received hundreds of complaints related to COVID-19 inside nursing homes and adult care facilities across the state and is investigating many of them.

For its part, the Queens Adult Care Center has denied any wrongdoing and repeated its belief that Roland’s allegations are “baseless.”

“Sadly, select elected officials and ProPublica have been intentionally misled with baseless assertions and utter fabrications crafted by the daughter of one of our long-term residents,” said Hank Sheinkopf, a crisis communications spokesperson hired by the facility. “We have strong reason to believe that this individual is seeking to use her father and other select residents as pawns in an attempt to extort the facility. We are considering our legal options.”

He said the facility has “worked tirelessly” to protect its residents and is unaware of a “potential investigation,” but understood that “the AG’s office has contacted many nursing homes, adult care, and assisted living facilities seeking information. We are glad to be a resource to the AG’s office and have nothing to hide.”

Bruce Schoengood’s 61-year-old brother, Bryan, lives in the facility and shared a room with one of the first residents to become infected with COVID-19 and subsequently die of the disease. Bruce told ProPublica he only learned that his brother’s roommate had died by happenstance during a casual conversation with his brother, and that he has complained for more than a month about a lack of communication from the facility. He said he had not yet heard from anyone with the attorney general’s office but would welcome such a conversation.

In the meantime, Bryan Schoengood, Willie Roland and King-Simpson are suing the facility under the Americans with Disabilities Act. In a 59-page complaint, the group has asked a federal judge to appoint a special master to oversee the facility at the home’s expense to ensure that residents there are safe.

The lawsuit argues that residents have experienced a “gross failure to provide the most basic level of care to safeguard their health and safety in the context of a global health pandemic. People with disabilities are exposed to high risks of contracting the virus with no or few preventative measures in place. Residents who fall sick are left to languish in their room without proper access to medical care.”

The lawsuit claims that because the facility has failed to follow state and federal guidelines, “COVID-19 is rampant in the facility among residents and staff alike.”

Alan Fuchsberg is the Manhattan-based personal injury and civil rights attorney representing the three Queens Adult Care Center residents.

In an interview, he said that the facility may not have the resources to properly follow the guidelines, which is why a special master should be assigned to work with a team of outside experts to make sure it can.

“Right now the residents are in a tinderbox,” he said. “And if you drop a match in there, all hell breaks loose. It should be run right. We don’t need dozens of people dying in all our nursing homes and adult care facilities. Some are running better than others and QACC sounds like a place that is not run up to standards.”

He and Bruce Schoengood pointed out that they are not currently suing for damages, but rather to persuade a court to immediately intervene and offer support to the facility’s roughly 350 residents.

Schoengood said the goals of the lawsuit are twofold.

“I think it is both short term and long term,” he said. “Immediate intervention to put proper protocols in place to treat the sick and stop the spread of coronavirus and to communicate with family members. And in the long term I would like to see this facility much better prepared to handle another pandemic or a second wave.”

Responding to the charges in the lawsuit, Sheinkopf again said that “the allegations are baseless and utter fabrications. Queens Adult Care Center (QACC) continues to meet all state issued guidelines.”

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Community pharmacies need millions of pounds extra “to keep their heads above water” during the COVID-19 pandemic, pharmacy bodies have warned.

To read the whole article click on the headline

Community pharmacists are to be included in the government life assurance scheme for staff working on the frontline of the COVID-19 pandemic, the health secretary, Matt Hancock has announced.

To read the whole article click on the headline

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I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]

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