Tag: 2021 News

NPR-KCUR in Kansas City reports that Pfizer Inc. and two other companies have agreed to pay $345 million to resolve long-running litigation over EpiPen price hikes. In 2007 an EpiPen package cost about $100. Today, it costs more than $650 without pharmacy coupons or manufacturer discounts.

EpiPens are auto-injectable devices that deliver the drug epinephrine, which is used to treat life-threatening allergic reactions known as anaphylaxis. Anaphylaxis is most commonly caused by food allergies but can also be caused by insect bites, medications and other substances.

The litigation dates to 2016, when numerous class action lawsuits were filed against Pfizer, Mylan and other defendants alleging they engaged in anticompetitive conduct in connection with their marketing of the EpiPen.

The lawsuits were transferred to federal court in Kansas City, Kansas, because of its geographical centrality. Trial was scheduled to begin this Sept. 7, but if Crabtree approves the settlement, Pfizer and the two other companies proposing to settle – Meridian Medical Technologies Inc. and King Pharmaceuticals Inc. – will be off the hook.

Multiple law firms have been involved in the complex litigation, which featured the production of over 11 million pages of documents and 158 depositions, according to court documents.

In documents filed in federal court in Kansas City, Kansas, the companies asked the court to grant preliminary approval to the settlement, which would end the litigation against the three companies.

The proposed settlement comes just three weeks after U.S. District Judge Daniel Crabtree granted summary judgment to another defendant, Mylan, on the plaintiffs’ racketeering claims and some antitrust claims. But he allowed other antitrust claims against Mylan to proceed to trial.

A Pfizer spokesperson said in an email that the company “denies any wrongdoing and continues to believe its actions were appropriate.”

“This resolution reflects a desire by the Company to avoid the distraction of continued litigation and focus on breakthroughs that change patients’ lives,” the spokesperson said.

Rex Sharp, a Prairie Village lawyer representing the plaintiffs, said in an email that his clients were pleased that Pfizer had agreed to the settlement while noting it still requires court approval.

He said the plaintiffs looked forward to trying the remaining claims against Mylan before a jury. Mylan owns the rights to the EpiPen brand, but the devices are manufactured by Pfizer.

A man who is unable to move or speak can now generate words and sentences on a computer using only his thoughts.

The ability comes from an experimental implanted device that decodes signals in the man’s brain that once controlled his vocal tract, as researchers reported Wednesday in The New England Journal of Medicine.

The man is currently limited to a vocabulary of just 50 words and communicates at a rate of about 15 words per minute, which is much slower than natural speech.

“This tells us that it’s possible,” says Edward Chang, a neurosurgeon at the University of California, San Francisco. “I think there’s a huge runway to make this better over time.”

A device that allowed people who can’t speak to communicate using brain circuits previously used for speech would be “more natural, and hopefully effortless compared to current assistive devices,” says Chethan Pandarinath, an assistant professor in the Department of Biomedical Engineering at Emory University and Georgia Tech.

Currently, people with paralysis who have lost the ability to speak usually rely on devices that use eye or head movements to spell out words one letter at a time. Some use a device that allows them to control a computer cursor with thoughts.

Chang’s team wanted to find a better solution for the man, identified only as BRAVO1 to protect his privacy. The name refers to his status as the first patient in a study called BRAVO, or Brain-Computer Interface Restoration of Arm and Voice.

BRAVO1, who is in his late 30s, has been paralyzed and unable to speak since he had a stroke 15 years ago, Chang says.

“The stroke left him nearly completely paralyzed in his arms and legs but also in the muscles of his vocal tract,” Chang says. But the areas of the brain that once issued speech commands are intact.

“We didn’t know if the speech commands in the brain would still work after 15 years,” he says. “And even if we could revive those dormant brain signals for speech, could we actually translate those into full words?”

To find out, the team implanted sensors on the surface of the man’s brain. Then it had a computer study the patterns of electrical activity produced when he attempted to speak 50 different words. The process took months.

Once BRAVO1 could reliably generate words on a computer screen, the team began having him form sentences. To help improve accuracy, the team added a program that analyzed the context of each word as it was added.

The system is a bit like the texting software on most smartphones. “So, for example, if one word is just not decoded correctly, this autocorrect function can correct it,” Chang says.

After months of adjustments to the system, the man was able to generate a word reliably every four seconds, or roughly 15 words per minute.

A device able to decode words in the brain could eventually help thousands of people who’ve had a stroke or a traumatic brain injury, says Krishna Shenoy, a professor in the School of Engineering at Stanford University.

The ability to recognize even 50 words in the brain is a huge achievement, Shenoy says. “But I think that’s just the tip of the iceberg. I think that could easily become 500 or 5,000 words.”

The U.S. government does not track death rates for every drug. However, the National Center for Health Statistics (NCHS) at the Centers for Disease Control and Prevention collects information on deaths involving many of the more commonly used drugs available through 2019 at a searchable database, called CDC Wonder. The NCHS also has 12 month-ending provisional data available by state and drug category.

The NCHS recently reported that drug overdose deaths rose by close to 30% in the United States in 2020, hitting the highest number ever recorded.

More than 93,000 people died from drug overdoses in 2020, according to provisional data released by the CDC’s National Center for Health Statistics. That’s a 29.4% increase from the 72,151 deaths projected for 2019.

In California, more than 9,500 people died from drug overdoses in 2020, up from 6,500 projected in 2019, a 45.9% increase.

“Overdose deaths from synthetic opioids (primarily fentanyl) and psychostimulants such as methamphetamine also increased in 2020 compared to 2019. Cocaine deaths also increased in 2020, as did deaths from natural and semi-synthetic opioids (such as prescription pain medication),” the NCHS said in a statement.

“This is the highest number of overdose deaths ever recorded in a 12-month period, and the largest increase since at least 1999,” Dr. Nora Volkow, director of the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, said in a statement.

“These data are chilling. The COVID-19 pandemic created a devastating collision of health crises in America,” added Volkow.

As in recent years, inappropriate use of opioids was behind most of the deaths. The NCHS reported that overdose deaths from opioids rose from 50,963 in 2019 to 69,710 in 2020.

President Joe Biden on Tuesday nominated Dr. Rahul Gupta of West Virginia to serve as the administration’s top drug policy official. The former state health commissioner is slated to become the first physician to ever lead the White House Office of National Drug Control Policy, or ONDCP, if confirmed by the Senate. If confirmed, he will replace Regina LaBelle, acting director of the ONDCP , who is an Obama administration alum.

Gupta, a primary care doctor, went on to serve as the chief medical and health officer at March of Dimes, a maternal-and-child advocacy group, after his time working in the West Virginia state government.

Gupta received criticism from some drug reform advocates, who expressed disapproval of the closure of a needle exchange program in Charleston, West Virginia, under his leadership.

“Dr. Gupta brings firsthand experience as a medical doctor and public health official using evidence-based strategies to address the overdose epidemic in West Virginia,” the White House said in a statement. “We hope he will be confirmed by the Senate soon.”

Some say this nomination is a signal that government is looking to integrate medical solutions to reduce the national drug problem under Dr. Gupta’s leadership.

51 year old Jason Vertz, of Fresno, and 45 year old Alana Powers, an inmate at the Central California Women’s Facility (CCWF) in Chowchilla, were each sentenced to five years and one month in prison for conspiracy to commit mail fraud and aggravated identity theft.

According to court documents, Vertz and Powers submitted several fraudulent unemployment insurance claims in Powers’ and other CCWF inmates’ names to the California Employment Development Department (EDD). Recorded jail calls and emails show that Powers and other inmates provided names, dates of birth, and social security numbers for inmates at CCWF to Vertz to submit the fraudulent claims. Shortly thereafter, the benefits were loaded onto debit cards that were mailed to the addresses the defendants provided.

The underlying applications for the claims stated that the inmates had worked within the prescribed period as maids, cleaners, fabrication welders, and other occupations, and that they were available to work, which was not true because they were incarcerated. The claims would have been denied if accurate answers had been given. EDD and the United States have suffered an actual loss of over $74,000 as a result of the fraud.

This case was the product of an investigation by the FBI, the California Department of Corrections and Rehabilitation Investigative Services Unit, and the California EDD. Assistant U.S. Attorneys Alexandre Dempsey and Joseph Barton are prosecuting the case.

On May 17, 2021, the Attorney General established the COVID-19 Fraud Enforcement Task Force to marshal the resources of the Department of Justice in partnership with agencies across government to enhance efforts to combat and prevent pandemic-related fraud. The Task Force bolsters efforts to investigate and prosecute the most culpable domestic and international criminal actors and assists agencies tasked with administering relief programs to prevent fraud by, among other methods, augmenting and incorporating existing coordination mechanisms, identifying resources and techniques to uncover fraudulent actors and their schemes, and sharing and harnessing information and insights gained from prior enforcement efforts.

Anyone with information about allegations of attempted fraud involving COVID-19 can report it by calling the Department of Justice’s National Center for Disaster Fraud (NCDF) Hotline at 866-720-5721 or via the NCDF Web Complaint Form at: https://www.justice.gov/disaster-fraud/ncdf-disaster-complaint-form.

An Orange County man is expected to be arraigned in federal court on an indictment charging him with defrauding victims who paid for COVID-related medical protective equipment that was never delivered, causing nearly $3 million in losses.

60 year old Christopher John Badsey, who lives Lake Forest, was arrested by FBI agents on July 8 without incident. He is charged with four counts of wire fraud and two counts of money laundering. He was arraigned in United States District Court in downtown Los Angeles.

According to an indictment returned by a federal grand jury on July 7, Badsey falsely represented that he had access to millions of boxes of medical-grade nitrile gloves through his Irvine-based company, First Defense International Security Services Corp. (FDI)

This type of personal protective equipment was in high demand and short supply during the COVID-19 pandemic.

Badsey allegedly entered into contractual agreements with victims, whom he required to provide a money deposit to inspect the gloves before delivery.

After receiving the deposits, Badsey allegedly instructed victims to travel to the Los Angeles area, where he claimed the gloves were stored in a warehouse. But when victims attempted to visit the warehouse, Badsey and other FDI employees allegedly provided excuses as to why the gloves could neither be inspected, nor delivered, to the victims.

Nitrile gloves were never provided to the victims, and Badsey is alleged to have absconded with the deposit money totaling nearly $3 million. After obtaining the victims’ wire deposits, Badsey and others are believed to have used those funds to make lavish purchases for their personal benefit.

If convicted of all charges in the six-count indictment, Badsey would face a statutory maximum sentence of 100 years in federal prison.