WORLD NEWS FLASH
UNITED STATES
On Aug. 4, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness – in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” said Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
As with other forms of depression, PPD is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure. It can present with symptoms such as cognitive impairment, feelings of sadness or inadequacy, loss of energy or suicidal ideation.
The efficacy of Zurzuvae for the treatment of PPD in adults was demonstrated in two randomized, double-blind, placebo-controlled, multicenter studies. The trial participants were women with PPD who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms began in the third trimester or within four weeks of delivery. In Study 1, patients received 50 mg of Zurzuvae or placebo once daily in the evening for 14 days. In Study 2, patients received another zuranolone product that was approximately equal to 40 mg of Zurzuvae or placebo, also for 14 days.
Patients in both studies were monitored for at least four weeks after the 14-day treatment. The primary endpoint of both studies was the change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale (HAMD-17), measured at day 15. Patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups. The treatment effect was maintained at Day 42 – four weeks after the last dose of Zurzuvae.
The labeling contains a boxed warning noting that Zurzuvae can impact a person’s ability to drive and perform other potentially hazardous activities. Patients also may not be able to assess their degree of impairment. To reduce the risk of harm, patients should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae.
The most common side effects include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (the common cold), and urinary tract infection. Use of Zurzuvae may cause suicidal thoughts and behavior. Zurzuvae may cause fetal harm. Women should use effective contraception while taking, and for one week after taking, Zurzuvae.
The daily recommended dose for Zurzuvae is 50mg. It should be taken once every day, for 14 days, in the evening with a fatty meal.
MASS SHOOTING UPDATE
Information recent as of 8-8-2023 at 12 p.m.
2023 Mass Shooting Stats: (Source: Mass Shooting Tracker – https://www.massshootingtracker.site/data/?year=2023)
Total Mass Shootings: 494
Total Dead: 607
Total Wounded: 1986
Shootings Per Day: 2.25
Days Reached in Year 2023 as of August 8: 220
Latest High Profile Incident (See above)
Location: East Oak Lane neighborhood- Philadelphia, PA
Time: Around 11:00 p.m. local time, Aug. 6.
Deceased: None.
Injured: 5 juveniles.
Shooter(s): Unknown.
Weapon(s): Semi-automatic.
Motive: Unknown.
Status: At-large.
Notes: In regard to 18 spent shell casings spread out in the area, Philadelphia Inspector D.F. Pace said, “About half of them are in the park itself, about half are outside on 2nd Street, indicating that the shooter or shooters were moving around quite a bit, and there was a lot of running around as this shooting took place.”
EUROPE
CHANGES COMING FOR WRONGLY CONVICTED CITIZENS
In the UK, wrongly convicted people will no longer face having “saved living costs” deducted from compensation payments following an update to guidance made August 6.
- Miscarriage of justice compensation guidance on “saved living expenses” scrapped
- Guidance changed with immediate effect
- “Common sense” change to make system fairer for victims of miscarriages of justice
This element of the guidance was added in 2006 and will be removed with immediate effect, applying to all future payments made under the miscarriage of justice compensation scheme.
Lord Chancellor and Secretary of State for Justice, Alex Chalk KC, said: “Fairness is a core pillar of our justice system and it is not right that victims of devastating miscarriages of justice can have deductions made for saved living expenses.
“This common sense change will ensure victims do not face paying twice for crimes they did not commit.
The miscarriage of justice compensation scheme is designed to help individuals restart and rebuild their lives. It is just one route in which an individual can receive compensation for a wrongful conviction, with other options including suing public bodies.
In order to be eligible for a payment under the scheme individuals must:
- Apply within 2 years of being pardoned or having their conviction reversed as a result of a newly discovered fact
- Have had their conviction reversed on the basis of a new fact which demonstrates beyond reasonable doubt they did not commit the offence
- Not be responsible for the non-disclosure of the new fact
Once eligible, the level of compensation is decided by an independent assessor. An award of compensation will normally fall into 2 parts:
- Compensation for the impact of the wrongful conviction on an individual, including damage to their reputation or to their physical or mental health, loss of freedom and inconvenience
- Loss of past or future earnings, expenses or legal costs resulting from their time in custody
Under previous guidance, the independent assessor could make a deduction from loss of past earnings based on “saved living expenses” such as rent or mortgage payments which were not incurred during their time in prison.
The maximum amount of compensation payable under the miscarriage of justice system is £1 million for 10 or more years imprisonment or £500,000 for up to 10 years.
CARIBBEAN
MEDIA PRODUCER SENT TO PRISON
A former media producer was sentenced Aug. 4 to four years and three months in prison for extortion and obstruction of justice related to his involvement in a scheme to obtain money in exchange for preventing the release of chat messages involving senior officials in the government of Puerto Rico.
According to court documents, in June 2019, Sixto Jorge Díaz Colón, 54, of San Juan, attempted to extort a public official in the government of Puerto Rico. Díaz Colón attempted to secure a $300,000 payment and other things of value from the official in exchange for the assurance that a third-party would not publicly disclose certain messages containing damaging information about various public officials in the government. When approached by the FBI in July 2019, Díaz Colón deleted messages containing information about his involvement in the scheme before surrendering his cellular telephone to the authorities.
Assistant Attorney General Kenneth A. Polite, Jr. of the Justice Department’s Criminal Division, U.S. Attorney W. Stephen Muldrow for the District of Puerto Rico, Assistant Director Luis Quesada of the FBI’s Criminal Investigative Division, and Special Agent in Charge Joseph Gonzalez of the FBI San Juan Field Office made the announcement.
The FBI San Juan Field Office investigated the case.
Trial Attorney Michael N. Lang of the Criminal Division’s Public Integrity Section (PIN) and Assistant U.S. Attorney Myriam Fernández-González for the District of Puerto Rico prosecuted the case. Former PIN Trial Attorney James Pearce, former Trial Attorney Byron Jones of the Criminal Division’s Computer Crime and Intellectual Property Section, and Assistant U.S. Attorney Timothy Henwood for the District of Puerto Rico provided assistance.
