William P. Danielczyk, theformer head of a Virginia-based defense contracting company, was sentenced today to serve 18 months in prison for failing to collect and pay more than $2.2 million in employee payroll taxes and engaging in theft of more than $186,000 from an employee pension plan.

On January 15, 2009, the U.S. Foreign Intelligence Surveillance Court of Review (FISC-R) published an unclassified version of its opinion in In Re: Directives Pursuant to Section 105B of the Foreign Intelligence Surveillance Act, 551 F.3d 1004 (Foreign Intel. Surv. Ct. Rev. 2008). The classified version of the opinion was issued on August 22, 2008, following a challenge by Yahoo! Inc. (Yahoo!) to directives issued under the Protect America Act of 2007 (PAA). Today, following a renewed declassification review, the Executive Branch is publicly releasing various documents from this litigation, including legal briefs and additional sections of the 2008 FISC-R opinion, with appropriate redactions to protect national security information. These documents are available at the website of the Office of the Director of National Intelligence (ODNI), www.dni.gov; and ODNI’s public website dedicated to fostering greater public visibility into the intelligence activities of the U.S. Government, IContheRecord.tumblr.com. A summary of the underlying litigation follows.

Buenas tardes. Muchas gracias por sus emotivas palabras y su calurosa bienvenida. It’s a privilege to help welcome the Hispanic National Bar Association to our nation’s capital for your 39th Annual Convention. And it’s a great pleasure, as always, to be in such distinguished company.

Attorney General Eric Holder announced Monday that the Justice Department will launch a new series of pilot programs in cities across the country to bring together community representatives, public safety officials and religious leaders to counter violent extremism. The new programs will be run in partnership with the White House, the Department of Homeland Security, and the National Counterterrorism Center.

The Justice Department announced Monday that Attorney General Eric Holder has recorded a video message as part of the Cartoon Network’s “I Speak Up” campaign to combat bullying. The project urges young people to speak up in order to help bring bullying situations to an end.

Thank you, John, not only for that kind introduction but also for your exemplary leadership as chair of the LSC Board. LSC really exemplifies that spirit Attorney General Robert Kennedy used to talk about – that as lawyers, we have an obligation to enlist our skills and ourselves in engagements that reach beyond the horizons of our parochial legal practices. And over the last five-and-a-half years I’ve served in this Administration, I’ve been fortunate to get to know John and LSC President Jim Sandman, and I know the movement for expanding access to justice in this country is better and stronger because they’re helping to lead this effort, so my thanks to them.

A Detroit-area hematologist-oncologist pleaded guilty today for his role in a health care fraud scheme, admitting that he administered unnecessary chemotherapy to fraudulently bill the Medicare program and private insurance companies. According to court records, the scheme enabled the doctor to submit approximately $225 million in claims to Medicare over six years.

Attorney General Eric Holder is set to announce a partnership between the Department of Justice’s Office of Juvenile Justice and Delinquency Prevention (OJJDP) and the Department of Housing and Urban Development (HUD). HUD will offer new grants to support collaborations between HUD-funded organizations, and civil legal aid programs and public defender offices. The grant funded collaborations will focus on expunging and sealing juvenile records – improving the chances that reentering youth will be able to obtain degrees, find work and secure housing. The announcement is set to be made this evening during the Attorney General’s remarks to the Legal Services Corporation 40th anniversary celebration.

Thank you, Dean [Martha] Minow, for those kind words – and thank you all for being here. I also want to recognize, and thank, my good friends John Levi and Jim Sandman for their leadership of the Legal Services Corporation over the years – and for the lifetimes of tireless work that they have dedicated to vulnerable populations from coast to coast. Finally, I want to thank each and every one of you – the dedicated men and women who are making LSC’s work possible; who are helping to shine a light on the current challenges facing the legal aid community; and who are leading us to redouble our efforts to forge the more just society that all Americans deserve. It’s gratifying to see so many diverse people and interests – from academia and government service, to private practice and corporate enterprise – converging to support equal justice under law.

U.S. Attorney Peter Smith for the Middle District of Pennsylvania, Special Agent in Charge John Kelleghan for Philadelphia, U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) and Special Agent in Charge Sidney M. Simon of the New York Field Office, Office of Export Enforcement, U.S. Department of Commerce announced that yesterday Harold Rinko, 72, of Hallstead, Pennsylvania, appeared before Senior District Court Judge Edwin M. Kosik in Scranton and pleaded guilty to conspiracy to illegally export laboratory equipment, including items used to detect chemical warfare agents, from the United States to Syria, in violation of federal law

Qui tam cases are a vital part of the Criminal Division’s future efforts. We encourage you to reach out to criminal authorities in appropriate cases, even when you are discussing the case with civil authorities. The sooner we on the criminal side learn about potential criminal conduct, the sooner we can investigate.

A true cooperator – whether a mobster or a company – must forthrightly provide all the available facts and evidence so that the most culpable individuals can be prosecuted. If a corporation wants credit for cooperation, it must engage in comprehensive and timely cooperation; lip service simply will not do. Corporations do not act criminally, but for the actions of individuals. The Criminal Division intends to prosecute those individuals, whether they’re sitting on a sales desk or in a corporate suite.

Thank you, Professor [Jennifer] Arlen, for those kind words – and thank you all for being here. It’s a privilege to be at New York University this afternoon

A federal grand jury in San Francisco returned an eight-count indictment against five real estate investors for their role in bid rigging and fraud schemes at foreclosure auctions in Northern California, the Department of Justice announced

An Alabama real estate investor pleaded guilty yesterday for his role in a conspiracy to commit mail fraud related to public real estate foreclosure auctions held in southern Alabama, the Department of Justice announced today

A federal grand jury in San Francisco returned three multi-count indictments against eleven real estate investors for their role in bid rigging and fraud schemes at foreclosure auctions in Northern California, the Department of Justice announced

A Northern California real estate investor has agreed to plead guilty for his role in conspiracies to rig bids and commit mail fraud at public real estate foreclosure auctions in Northern California, the Department of Justice announced

Attorney General Eric Holder announced today that the Department of Justice and 19 states and the District of Columbia have entered into a $1.375 billion settlement agreement with the rating agency Standard &s Financial Services LLC, along with its parent corporation McGraw Hill Financial Inc., to resolve allegations that S&s 2013 lawsuit against S& true credit risks. Other allegations assert that S&s business relationships with the investment banks that issued the securities.

A Northern California real estate investor has agreed to plead guilty for his role in bid rigging and fraud conspiracies at public real estate foreclosure auctions in Northern California, the Department of Justice announced

Preet Bharara, the United States Attorney for the Southern District of New York, announced that ROBERT STEWART, the father of former investment bank managing director Sean Stewart, pled guilty today to participating in a conspiracy to trade on inside information about several mergers and acquisitions announced between 2011 and 2014

Remarks as prepared for delivery

Thank you, Professor [Jennifer] Arlen, for that kind introduction and for everything you and your colleagues have accomplished at NYU

A Georgia real estate investor pleaded guilty today for his role in conspiracies to rig bids and commit mail fraud at public real estate foreclosure auctions in Fulton and DeKalb counties, Georgia

Remarks as prepared for delivery

Thank you, Buddy [Wilmer Parker], for that kind introduction

A Las Vegas man pleaded guilty today to conspiracy for his role in an investment fraud scheme that promoted fraudulent investment opportunities and caused more than $5 million in losses to investors

A Las Vegas man was sentenced today to 60 months in prison for his role in an investment fraud scheme that promoted fraudulent investment opportunities and caused more than $5 million in losses to investors

ALEXANDRIA, Va

ALEXANDRIA, Va

ALEXANDRIA, Va

The U.S. Food and Drug Administration approved a new high-pressure ventilator developed by NASA to treat coronavirus or COVID-19 patients. The space agency is offering the designs for licensing on a royalty-free basis during the time of the pandemic, hoping to increase the availability of life-saving medical devices.

These are exciting times for Vapotherm Inc. (VAPO) whose share price has almost doubled in value since the beginning of this year.

High rates of opioid prescribing have contributed to the current U.S. opioid epidemic and the steady increase in overdose deaths across the country. Prescribers wrote an all-time high of 255 million opioid prescriptions in 2012, and though that rate has since declined.

The spread of COVID-19 is placing unprecedented strain on Philadelphia’s hospitals, public health systems, and residents. Although the full effects of the emergency have yet to be realized, newly released data from 2018 and 2019 provides insight on the state of public health in the city before the pandemic.

The American Herbal Products Association submitted nearly 100 pages of comments to the Food and Drug Administration Center for Food Safety and Applied Nutrition identifying ways to improve regulations, guidance documents and enforcement practices to better protect public health.

New Legal Motion Challenges Tony Huge’s Supposed Unpaid Role in Enhanced Athlete

A recent study conducted by researchers at Tufts University suggests that consuming 1.5 ounces of almonds per day, compared to no almond consumption, may help reduce CVD risk factors such as elevated LDL cholesterol levels, and as a result, reduce an individual's healthcare costs associated with treating such conditions.

President Sebastián Piñera, Chair of APEC Chile 2019, announced that APEC Leaders’ Week will not be held in Chile this year.

We may call them “site inspections”, but it’s not the site that’s being inspected when a regulator visits; it’s the Principal Investigator. Though a PI typically delegates study tasks to other staff members, he or she remains solely responsible for the conduct of the study. In fact, the ICH E6(R2) addendum adds two new sections to the international guidance that emphasize PI supervision.

That’s what makes the Delegation of Authority (DoA) log so important and why regulatory inspectors care about it so much. A DoA log serves as evidence that a PI has assigned study tasks only to those staff members with the education, training, and experience to carry them out. If delegates are unqualified to perform their tasks, subject safety could be at risk and it’s highly likely that the study data would be unusable.



Monitors – you can really make a big contribution here. At the outset of the study, you can verify that your PI has made appropriate delegations and the DoA log is complete. You can cross-match the log with training records, CVs, licenses, and source documents and correct any problems as early in the study as possible. Then, throughout the study, you can verify that the DoA log is being maintained.

Coverage
Without referencing any other site document, monitors can spot two types of DoA log omissions.

(1) Missing Assignments. Are there study tasks to which no one has been delegated? The tasks in a DoA log are often represented by a short code to conserve space. A legend at the end of the log translates the code into its corresponding task. Monitors can compare the legend to the DoA log entries to see if any tasks are omitted.


(2) Gap in Assignments. Due to staff turnover, reassignment, leaves of absence, etc., delegation for a task frequently does not last the duration of the entire study. A column in the DoA log indicates the delegation start and stop date.  Monitors can check to make sure that when the delegation for a task ends for one staff member, it is picked up by another.

Qualifications
Once you’re satisfied the DoA log completely covers all tasks for the duration of the study, you can check to make sure delegates have the necessary qualifications. You’ll want to compare the log with training records, CVs, and medical licenses from the regulatory binder.

• Has the staffer charged with recording vital signs during a subject visit been formally trained to take blood pressure? Is it documented?
• Did an incoming pharmacist receive protocol training prior to the start date of his study assignments?
• Does state law allow a registered nurse to dispense investigational product, or is a nurse practitioner or physician’s assistant required? Does the protocol require only an M.D. conduct certain procedures? Does the DoA log show the requirement is being followed?

Study Procedures
Even after the focus of the monitoring visit moves past the DoA log itself, you should revisit the log during source document review.

• Have any study tasks been conducted by staff members who have not received official delegation to do so?
• Perhaps the protocol requires a blinded IP dispenser. If so, has the delegated dispenser conducted any other study procedure?

PI Oversight
The PI is responsible for ensuring subject safety, compliance with the regs and the protocol, and control of the investigational product. That obligation cannot be delegated away. PI oversight is critical to a successful study, and the DoA log is where PI oversight starts.

Procedures that are performed by unqualified or ineligible personnel put both study participants and study data at risk. These are the very things regulatory inspectors work to guard against. Good monitors know it and make verifying the DoA log a priority.

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A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

Last month, I scheduled one-on-one discussions with our most experienced GCP auditors to ask each of them the same question: What surprises you most about the audits you conduct?

I guess you could say that I was the one who was surprised. I’m not sure exactly what I was expecting to hear, but I thought my teammates were going to talk about things that were new. Instead, I heard a lot more about things that have been around for a long time. To a person, my colleagues said they were surprised to be observing some of the same audit findings they were observing 30 years ago...which *is* surprising when you consider most of them were mere children at the time. ;-)  It seems we have some stubbornly persistent quality and compliance issues in the biopharma industry that decades of neither experience nor technology have seemed to remedy. And the problems are not just persistent; they’re interrelated.



Standard Operating Procedures (SOPs)
It’s quite common for auditors to encounter sponsors, CROs, and sites that lack an adequate set of SOPs to describe local procedures. There are several reasons for this. Sometimes it’s a lack of resources. Sometimes smaller, established organizations believe writing it all down is unnecessary, as “people know their jobs.” Sometimes newer companies are simply unaware that written procedures are required for particular operations. But when procedures are not documented, organizations are unable to demonstrate GCP compliance, cannot ensure that activities are performed correctly or consistently, and have difficulty training new staff members. (We’ll come back to training in a bit.)

Frequently missing from a good working set of SOPs are procedures for Disaster Recovery, Handling of Suspected Fraud, and Management of Regulatory Inspections. These SOPs are not used for day-to-day operations, so perhaps that’s why they don’t garner as much attention. Nevertheless, the inability to recover from a disaster, protect the organization from fraud allegations, or pass a regulatory inspection can sink a company.

A fourth SOP that is commonly absent from the set is the document that describes how to write, approve, distribute, revise, and retire SOPs. Also frequently missing from a working set of SOPs is our next topic: Training.

Training
Training can be expensive and time-consuming, and companies increasingly have to do more with less. In-person training has largely been replaced by computer-based systems, on-site training has given way to distance learning, and mentoring has gone the way of the dodo.

The good news is that study sites typically adhere to formal GCP training requirements. What’s often missing, though, is the training that connects GCP concepts to everyday activities. A trainee might correctly answer a multiple-choice question about audit trails, but without that “last mile” of coaching, use Wite-Out to correct a source document error. This is where SOPs come in. When training is conducted using well-written SOPs, it can help bridge the gap between standard GCP training and specific site operations.

It is not uncommon for study-specific training to be lacking in CROs – protocol training, device training, computer systems user training. As part of their vendor oversight procedures (also an SOP!), sponsors should be making sure that CRO staff is adequately trained. 

Trial Master Files (TMFs)
Whether paper or electronic, it’s common for TMF documents to be missing or expired. Replacements for these documents can usually be produced and filed at the time of the audit. Misfiled documents are another matter; they are already there but cannot easily be found. Locating and refiling them essentially doubles the time and cost of the original effort. For example, documents from multiple labs, such as certificates, credentials, vendor audit results, etc., are often mistakenly commingled. Documents must be sorted and refiled so that each facility listed on the 1572 has its own file or electronic folder.


Another very common mistake is treating every document on letterhead as if it’s general correspondence. Search for the word “letter” in the DIA Reference Model and you can see how many opportunities exist for misclassifying correspondence. For example, an IND safety report sent by the sponsor on letterhead should be filed under “Notification of Safety Information,” Section 8.3.18 in ICH E6(R2), not “Relevant Communications,” Section 8.3.11. In an eTMF, an IRB approval letter belongs in 04.01.02, its designated DIA Reference Model position, not 04.04.01, which is reserved for general communication.

The root cause of these misfilings? The filer does not know enough about the filing structure of the TMF and often is not familiar enough with clinical research to know the purpose of each document and where it belongs. The corrective action? Training. Training on the TMF plan, the TMF Management SOP, ICH GCP, and study operations in general.

Technology to the Rescue?
No doubt, CTMSs, eTMFs, eCRFs, ePRO, and other systems have improved clinical operations and reduced error. However, three decades of technological advances have done little to address the most common quality and compliance issues encountered by GCP auditors – and by extension regulators. Some might find that discouraging, but isn’t it also a little satisfying that the solution to our most persistent problems comes down to human communication?

______________________________________________________________________
A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

On Friday, 21 emerging medical device companies will present their technologies and business plans to a group of local investors at the annual MedTech Showcase, hosted by the Massachusetts Medical Device Industry Council. More than 300 venture leaders and business leaders are expected to attend the event tomorrow, Oct. 28 from 8 a.m. to 2 p.m. at the Westin Waltham, 70 Third Ave. As a main event, John McDonough, president and CEO of Lexington-based T2 Biosystems (Nasdaq: TTOO), will be interviewed…

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

Rick Bright confirmed as having left his position as director of BARDA as the agency provides aid to develop solutions for COVID-19.

The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading →

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

Posted by Roger Bate My op-ed with Dinesh Thakur in The Hill today highlights the recent recommendation by Europe's chief drug regulator to suspend 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. We urge U.S. Federal regulators to follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation. You can read the op-ed here [...]

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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All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen.

To read the whole article click on the headline

GlaxoSmithKline is hard at work with partner Sanofi in getting a vaccine tested for COVID-19, but this morning it said it was now also entering the race to treat patients already hit with the disease.

The dietary supplement industry as a whole is enjoying booming sales as consumer stock up on products to support optimum health. But an industry strategist warns that that sales bump is likely to be ephemeral, and brands that are not strategizing vigorously now may be caught out in the near future.