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Month: March 2019
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3/28/2019
PRESS RELEASE
The U.S. Food and Drug Administration today approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. This is the first time that the FDA has approved a treatment for nr-axSpA.
“Today’s approval of Cimzia fulfills an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there has been no FDA-approved treatments until now,” said Nikolay Nikolov, M.D., associate director for rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
Nr-axSpA is a type of inflammatory arthritis that causes inflammation in the spine and other symptoms. There is no visible damage seen on x-rays, so it is referred to as non-radiographic.
The efficacy of Cimzia for the treatment of nr-axSpA was studied in a randomized clinical trial in 317 adult patients with nr-axSpA with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) levels and/or sacroiliitis (inflammation of the sacroiliac joints) on MRI. The trial measured the improvement response on the Ankylosing Spondylitis Disease Activity Score, a composite scoring system that assesses disease activity including patient-reported outcomes and CRP levels. Responses were greater for patients treated with Cimzia compared to patients treated with placebo. The overall safety profile observed in the Cimzia treatment group was consistent with the known safety profile of Cimzia.
The prescribing information for Cimzia includes a Boxed Warning to advise health care professionals and patients about the increased risk of serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis (infection in the blood steam), invasive fungal infections (such as histoplasmosis, an infection that affects the lungs), and other infections. Cimzia should be discontinued if a patient develops a serious infection or sepsis. Health care providers are advised to perform testing for latent TB and, if positive, to start treatment for TB prior to starting Cimzia. All patients should be monitored for active TB during treatment, even if the initial latent TB test is negative. The Boxed Warning also advises that lymphoma (cancer in blood cells) and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, of which Cimzia is a member. Cimzia is not indicated for use in pediatric patients. Cimzia must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.
Cimzia was originally approved in 2008 and is also indicated for adult patients with Crohn’s disease, moderate-to-severe rheumatoid arthritis, active ankylosing spondylitis (AS) and moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The FDA granted the approval of Cimzia to UCB.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Editor’s note: The Sackler Family owns Perdue Phara, the company that developed Oxycontin.
Press release
NEW YORK – Today, Attorney General Letitia James filed the nation’s most extensive lawsuit against the manufacturers, Sackler Family, and distributors of opioids for their role in the opioid epidemic that has taken hundreds of thousands of lives and devastated families and communities. The lawsuit alleges that through years of false and deceptive marketing, and by ignoring their duties to prevent the unlawful diversion of controlled substances, these six national prescription opioid manufacturers, the Sackler Family, and four national prescription drug distributors are largely responsible for creating the opioid epidemic that has ravaged New York, causing widespread addiction, overdose deaths, and suffering. This lawsuit breaks new ground by setting forth an extensive set of facts alleging that prescription drug distributors failed to exercise their duties to detect and report diversion of opioids through poorly designed, poorly resourced, and poorly executed suspicious order monitoring programs.
The amended complaint expands an earlier lawsuit filed by the Office of the Attorney General against Purdue Pharma, and sets forth the Attorney General’s findings from a multi-year, industry-wide investigation of these opioid market participants.
The manufacturers named in the amended complaint include Purdue Pharma and its affiliates, members of the Sackler Family (owners of Purdue) and trusts they control, Janssen Pharmaceuticals and its affiliates (including its parent company Johnson & Johnson), Mallinckrodt LLC and its affiliates, Endo Health Solutions and its affiliates, Teva Pharmaceuticals USA, Inc. and its affiliates and Allergan Finance, LLC and its affiliates. The distributors named in the complaint are McKesson Corporation, Cardinal Health Inc., Amerisource Bergen Drug Corporation, and Rochester Drug Cooperative Inc.
“The opioid epidemic has ravaged families and communities across New York,” said Attorney General Letitia James. “We found that pharmaceutical manufacturers and distributors engaged in years of deceptive marketing about the risks of opioids and failed to exercise their basic duty to report suspicious behavior, leading to the crisis we are living with today. As the Sackler Family and the other defendants grew richer, New Yorkers’ health grew poorer and our state was left to foot the bill. The manufacturers and distributors of opioids are to blame for this crisis and it is past time they take responsibility.”
Specifically, the complaint alleges that the opioid epidemic is especially destructive to New York because of the fraud, willful misconduct, and gross negligence of the distributors who buy controlled substances in bulk from the manufacturers and sell to individual pharmacies and other licensed dispensers. These systemic failures led to massive shipments of opioids to specific pharmacies in New York that showed numerous “red flags,” such as a high percentage of prescriptions paid for in cash or written by a relatively small number of providers who have been charged with, or convicted of, illegal prescribing.
The complaint also alleges that manufacturers implemented a common “playbook” to mislead the public about the safety, efficacy, and risks of their prescription opioids. Manufacturers pushed claims that opioids could improve quality of life and cognitive functioning, promoted false statements about the non-addictive nature of these drugs, masked signs of addiction by referring to them as “pseudoaddiction” and encouraged greater opioid use to treat it, and suggested that alternative pain relief methods were riskier than opioids, among other grossly misleading claims. They utilized a vast network of sales representatives (“detailers”) to push these dangerous narratives and to target susceptible doctors, flood publications with their deceptive advertisements, and offer consumers discount cards and other incentives to entice them to request treatment with their products.
The Attorney General’s lawsuit further asserts that the manufacturers and distributors obtained their licenses to sell opioids and other controlled substances in New York by representing, falsely, that they had complied with state requirements governing the distribution of these products, and that their licenses may be revoked. The complaint also sets forth detailed False Claims Act allegations based on opioid prescriptions that were paid under state health programs due to the defendants’ misconduct, with specific examples of overprescribing by New York providers directly exposed to the manufacturer’s deceptive marketing.
The public health crisis that has ensued has taken the lives of thousands of New Yorkers and left many more addicted to opioids, whether prescribed by health care providers or obtained on the streets. The complaint alleges that because of their false and deceptive marketing of opioids and flooding New York with opioid pills, manufacturers and distributors bear responsibility for much of the human toll of this crisis.
Each day, more than 130 people in the United States, about nine of whom live in New York, die as a result of opioid related overdoses. In 2017 alone, more than 3,200 New Yorkers died from opioid overdose. From 2000 to 2011, the number of prescriptions for opioid drugs produced by the manufacturers in this complaint more than quadrupled nationwide, despite no scientific basis for any significant increase in opioid treatment as medically necessary or appropriate. These prescriptions have proven to be an incredibly dangerous gateway to forms of illicit drugs – research shows that up to 80% of heroin users first became addicted as a result of exposure to prescription pills.
Through their illegal actions, the amended complaint alleges that manufacturers and distributors have harmed New York financially by causing the state to spend hundreds of millions of dollars on services related to addiction treatment and support programs, antidote treatments and training, and medications and services to treat the additional physical morbidities that accompany opioid use disorder. The state has also had to pay false claims for inappropriate opioid prescriptions through its Medicaid program, its employee and retiree health plans, and its Workers’ Compensation Program.
“Opioid dependency and related overdoses are a public health crisis that must be tackled from every angle,” said Joshua D. Lee MD, MSc, Associate Professor of Population Health and Medicine/General Internal Medicine and Clinical Innovation at the NYU School of Medicine and Director of the NYU Fellowship in Addiction Medicine. “As we seek to find the best interventions for opioid use disorders, those who fueled this crisis, marketing useful but addictive drugs into the market without disclosing the risks, must be held responsible. I thank Attorney General Letitia James for taking this bold action so we can beat this epidemic.”
“The opioid crisis has had a devastating impact on our state – each day, we treat hundreds of New Yorkers and their families struggling with addiction,” said Gary Butchen, LCSWR, CASAC, SAP; Executive Director, Bridge Back to Life Center, Inc. “In 30 years of providing services, we have seen an exponential increase this decade in patients seeking assistance for opioid addiction compared to alcohol and other drugs. With Attorney General Letitia James’ lawsuit, those who made these lethal, addictive drugs so widely available may finally be held accountable.”
The litigation team on this matter is headed by David Nachman, Counsel for Opioids and Impact Litigation, and includes John Oleske, Senior Enforcement Counsel; Christopher Leung and Sara Mark, Special Counsel in the Health Care Bureau; Elizabeth Chesler, Carol Hunt, Diane Johnston, Michael Reisman, Jennifer Simcovitch and Paulina Stamatelos, Assistant Attorneys General in the Health Care Bureau; Lawrence Reina, Assistant Attorney General in the Labor Bureau; Conor Duffy, Assistant Attorney General in the Civil Rights Bureau; Health Care Bureau Legal Assistant David Payne; and Corey Nugent in the IT Practice Technology Group. The Health Care Bureau is overseen by Bureau Chief Lisa Landau.
Significant analysis was provided by the Research and Analytics Department, principally Data Scientist Katie Rosman, with additional assistance from Data Scientist Gautam Sisodia, Data Analyst Anushua Choudhury and other staff and interns under the leadership of Deputy Director Megan Thorsfeldt and Director Jonathan Werberg.
Editor’s Note: DON’T FORGET TO GET YOUR YEARLY MAMMOGRAM! A mammogram could save your life!
FOR IMMEDIATE RELEASE:
Proposed rule would require breast density reporting, enhance the FDA’s ability to enforce mammography facilities’ compliance with standards
Today, the U.S. Food and Drug Administration announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care.
For the first time in more than 20 years of regulating mammography facilities, the agency is proposing amendments to key regulations that would help improve the quality of mammography services for millions of Americans. Today’s actions would expand the information mammography facilities must provide to patients and health care professionals, allowing for more informed medical decision-making. It would also modernize mammography quality standards and better position the FDA to enforce regulations that apply to the safety and quality of mammography services.
“Breast cancer is one of the most worrisome health concerns facing women. The FDA plays a unique and meaningful role in the delivery of quality mammography to help patients get accurate screening to identify breast health problems early, when they can be effectively addressed,” said FDA Commissioner Scott Gottlieb, M.D. “As part of our overall commitment to protecting the health of women, we’re proposing new policies to modernize our oversight of mammography services, by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting. We’re committed to making sure patients have access to high quality mammography. Today’s proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field.”
According to the National Cancer Institute (NCI), approximately 12.4 percent of women will be diagnosed with breast cancer at some point during their lifetime. NCI estimates that, in 2018, more than 260,000 women were diagnosed with breast cancer and more than 40,920 women died of the disease. Aside from skin cancer, breast cancer is the most common cancer among women and the second leading cause of death. Additionally, mammography can be an important tool in detecting male breast cancers. According to the NCI, breast cancer may occur in men at any age, but usually occurs in men between 60-70 years of age.
The FDA’s proposal would amend regulations issued under the Mammography Quality Standards Act of 1992 (MQSA), which Congress passed to ensure quality mammography for early breast cancer detection. The MQSA authorizes FDA oversight over mammography facilities, including their accreditation, certification, annual inspections and enforcement of standards to help ensure mammography facilities provide quality care.
Among the proposed amendments to improve communication and medical decision making is the addition of breast density information to the mammography lay summary letter provided to patients and to the medical report provided to their referring health care professionals. Mammograms of dense breasts—breasts with a higher proportion of fibroglandular tissue compared to fatty tissue—can be difficult to interpret because the dense tissue can obscure signs of breast cancer and lower the sensitivity of the image. Dense breasts have also been identified as a risk factor for developing breast cancer. The FDA is proposing specific language that would explain how breast density can influence the accuracy of mammography and would recommend patients with dense breasts talk to their health care provider about high breast density and how it relates to breast cancer risk and their individual situation.
The proposed amendments also seek to enhance information provided to health care professionals by proposing to codify three additional categories for the assessments of mammograms, including adding an important category titled “known biopsy proven malignancy,” which would help identify for health care professionals those cases where cancer being mammographically evaluated for therapy are already known and identified. In addition, under the proposed regulations, both health care professionals and patients would receive in their reports and lay summary letters more detailed identifying information about the mammography facility to aid in post-exam communications.
“The FDA is committed to advancing efforts that improve the health of women. We believe the proposed rule would help empower patients and health care professionals by proposing improvements to the information facilities communicate to them, helping to facilitate the sometimes difficult conversations about potential risks for breast cancer,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Given that more than half of women over the age of 40 in the U.S. have dense breasts, helping to ensure patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy. Today’s proposed amendments are part of the agency’s broader commitment to supporting new innovations and methods to prevent, detect and treat cancer. We are dedicated to working across the agency and with stakeholders to provide patients with tools and information to fight breast cancer effectively.”
The proposed amendments would also modernize mammography quality standards and better position FDA to enforce the MQSA regulations and take action when violations are found. Some of these proposed changes include:
- Expressly stating that the FDA can directly notify patients and their health care professionals, should facilities be unwilling or unable to do so, that mammography at a facility did not meet quality standards and that reevaluation or repeat of the mammogram at another certified facility may be needed;
- Requiring that only digital accessory components specifically FDA approved or cleared for mammography be used, or that facilities use components that otherwise meet the requirements under the rule;
- Strengthening record-keeping requirements to minimize information loss and improve access to and transfer of patient mammography records.
“Once finalized, these proposed amendments will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “While the majority of certified mammography facilities are dedicated to providing high levels of patient care, today’s proposed regulations would enhance the FDA’s ability to communicate directly, if needed, with patients and their health care professionals in cases where facilities did not meet our quality standards and are not adequately communicating with patients about their facillities’ deficiencies. This is intended to help ensure important information that could affect decisions about patient care—such as the potential need for further evaluation or a repeat of a mammogram—is communicated as quickly as possible.”
THE SENIOR CENTER:
Silver Sneakers Cardio 9:00 AM
Pinochle Tournament 12:45 PM
INCUBUS
August 6th, 5:00 PM Canalside Buffalo. Take note that this is a TUESDAY NIGHT SHOW. All other shows at Canalside will be on Thursdays. VIP Tickets (through Eventbright) are $40-includes a few drinks, better bathrooms(!!), Access to front of stage, and more. General admission tix are $10 and go on sale in May. You can pick up General Admission tix at any Consumer Beverages location, the Canalside info kiosk or Eventbright.
Richard R. McMullen “Rocky”, 66 of Rochester, passed away unexpectedly on Monday (April 22, 2019) at the Hill Haven Nursing Home in Penfield, NY.
He was born May 15, 1952 in Pembroke, NY, a son of the late John and Margaret Morrison McMullen.
Rick was formerly employed by Coca Cola Co. in Batavia and Rochester and retired from R.B. U’Ren Equipment in Rochester. He was a dedicated fan of the Buffalo Bills.
Survivors include his wife, Marie Pappalardo McMullen of Rochester. Step Daughter-in-Law Brenda (John) Crabtree and grandchildren Katelyn Crabtree and Liam Crabtree Very close friend, Randy Williams of Rochester. Also survived by aunts, uncles and cousins.
Family and friends are cordially invited to share in a memorial service on Saturday (May 4th) at 2:00pm at the J. Leonard McAndrew Funeral Home, LLC, 2 Bogue Ave., Batavia, NY.
Memorial contributions may be directed to the Open Door Mission, 156 N. Plymouth Avenue, Rochester, NY 14608 or Lollypop Farm, 99 Victor Rd, Fairport, NY 14450. Expressions of sympathy may be offered to the family at: www.mcandrewfuneralhomes.net.
Arrangements were entrusted to the J. Leonard McAndrew Funeral Home, LLC, 2 Bogue Ave., Batavia, NY 14020. Ronald Konieczny II, Director.
Frederick C. Bedford Sr.
Frederick C. Bedford Sr. – 74, of Akron died March 23, 2019 peacefully with his family by his side at Millard Fillmore Suburban Hospital. He was born November 5, 1944 in Lockport NY to the late Clarence Frederick and Lucy Lorraine (Urlel) Bedford.
He is survived by his loving wife of 54 years Gail Francis (Bower), four children Jacqueline Hill (Scott Allen), Frederick Jr. (Roxanne) Bedford, Jenifer (Mark) Sczygielski and Steven Bedford. Five grandchildren Matthew (Courtney), Andrew, Erika, CJ, and Kaida. Also survived by a sister Carolee (Gerald) Striffler and a niece and nephew Melissa (John) McClintock, Scott (Jennifer) Striffler.
Fred drove truck for 31 years starting in 1963. He also loved to play cards with friends at the Newstead Senior Center.
There will be no calling hours. Fred donated his body to The Jacobs School of Medicine & Biomedical Sciences, University at Buffalo. In liew of flowers, gifts may be directed to the U.B. Foundation, Anatomical Gift Program, SUNY at Buffalo, PO Box 900, Buffalo NY 14226-0900
American Legion 900 Meat Raffle
Check out this table full of meat for the grand finale! Keep in mind this raffle went on for HOURS, and this is the end part. And for the first time, I actually WON SOMETHING! I won a nice package of NY Strip Steaks. They also had, pork roasts, chicken fingers, Chicken breasts, bags O shrimp, hams…..SO much stuff, and remember this table is just the finale. There was tray after tray after tray of meat coming out all day.
The next event for The American Legion is the Annual Spring BBQ April 13. See you there. -JAP-
