Health

FDA Panel Backs First-in-Class Cholesterol Drug

Published

9 years ago

June 10, 2015

Oakland Post

Sanofi Aventis (AP Photo)

MATTHEW PERRONE, AP Health Writer

GAITHERSBURG, Md. (AP) — Federal health advisers on Tuesday recommended approval for a highly anticipated cholesterol drug from Sanofi and Regeneron Pharmaceuticals, but with the caveat that more data is needed about its long-term ability to reduce heart attacks.

The expert panel recommended by a 13-3 vote that the Food and Drug Administration approve the injectable drug, called Praluent.

But in an unexpected development, a number of panelists said the drug should only be used in patients with abnormally high cholesterol levels caused by an inherited disorder. Those panelists said they wanted to see more data about whether the drug ultimately reduces heart problems, before it is used more broadly.

“I personally fall on the side of having optimism, but I need to see the cardiovascular outcome study to know,” said Dr. Philip Sanger of Stanford University, who voted for the drug.

If the FDA follows the group’s recommendation, the drug could be approved for a much smaller population than its developers have proposed.

Praluent is part of a new class of injectable drugs that lower cholesterol more than older medications called statins, which have been the standard treatment for more than 20 years. A similar drug from Amgen will go before the same panel on Wednesday.

Both drugs block a substance called PCSK9, which interferes with the liver’s ability to remove cholesterol from the blood. Analysts expect the drugs to grow into blockbuster sellers, generating billions of dollars in new sales. But Tuesday’s meeting underscores the uncertainty about who should receive such medications.

More than 73 million U.S. adults, or nearly one-third, have high LDL cholesterol, according to the Centers for Disease Control and Prevention. Those patients have twice the risk of heart disease, the leading cause of death in the U.S.

Paris-based Sanofi and Regeneron, which is based in Tarrytown, New York, have suggested marketing their drug to a large group of patients, including those who are at high-risk for heart attacks and those who cannot tolerate statin drugs due to side effects.

But many panelists said they would limit the drug’s use to a much narrower group of patients who have abnormally high cholesterol levels caused by a family disorder.

“I am really only comfortable with the risk-benefit equation in that population,” said Michele Orzsa, the panel’s consumer representative.

Key to the panel’s decision was whether lowering bad, or LDL, cholesterol translates into reduced heart attacks. For over 20 years, the FDA has used reduced LDL levels as a benchmark to approve cholesterol drugs, including statins like Lipitor and Zocor.

But recent studies of drugs like niacin have shown that reducing cholesterol levels does not always lead to reductions in heart attack, stroke and related problems.

The FDA’s internal scientists pressed panelists on whether they thought lower LDL cholesterol was still an accurate predictor of a drug’s benefit.

“I don’t believe we have enough data today to say that LDL, with a new drug class, is sufficient for approval,” said Dr. William Hiatt, of the University of Colorado’s School of Medicine, who voted against the drug.

Despite the measured endorsement, company representatives said they were “gratified” by the meeting’s outcome.

“This is one of the next big milestones for this product and the promise it can deliver to patients,” Bill Sasiela, a vice president with Regeneron Pharmaceuticals Inc.

Regeneron’s stock fell about 3 percent in extended trading following the announcement. Sanofi’s U.S.-traded shares rose about 1 percent.

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Activism

NAACP California-Hawaii State Convention Highlights Black Voter Engagement, and More

A Friday panel featuring NAACP Chairman Leon W. Russell and Regina Wilson, Executive Director of California Black Media, examined Project 2025, an initiative perceived as a potential threat to civil rights, healthcare access, and environmental protection. This session emphasized Project 2025’s projected impact on Black communities, noting that policies within the initiative could diminish gains in civil and environmental rights over decades. Russell and Wilson highlighted the need for vigilant monitoring and community mobilization to address these challenges.

Published

9 hours ago

November 4, 2024

Oakland Post

NAACP State Conference President Rick Callender (right) engages in a discussion on voter engagement and community advocacy with NAACP President and CEO Derrick Johnson during the 37th NAACP California-Hawaii State Convention in Los Angeles. Photo by Rich Woods.

By Bo Tefu, California Black Media

The 37th NAACP California-Hawaii State Convention concluded on Sunday, Oct 27, following four days of discussions and workshops at the Los Angeles Airport Marriott. Bringing together civil rights leaders, policymakers, and advocates from California and Hawaii, the convention operated under the theme “All In.” The participants discussed critical issues impacting Black communities, including criminal justice reform, health equity, economic empowerment, education, environmental justice, and voting rights.

On Saturday, the President’s Fireside Chat brought together NAACP President Derrick Johnson and CA/HI State Conference President Rick Callender, who discussed the urgency of voter engagement and community advocacy.

Guest speakers included Congresswoman Maxine Waters (D-CA-43), who spoke at the Women in NAACP (WIN) Labor Luncheon about the intersection of labor rights and civil rights. California State Superintendent Tony Thurmond delivered remarks at the Leadership Dinner on education equity, focusing on policies to ensure all students have access to high-quality education.

Honors were given to longtime social justice advocate and former Assemblymember Mike Davis for his work in community activism. At the same time, actor and activist Danny Glover and the Rev. Dr. Amos C. Brown received the 2024 Legacy Hall of Fame Awards, recognizing their lifelong commitments to advancing civil rights.

The convention also offered practical workshops, including “What’s On Your Ballot?,” where coalition leaders provided analyses of California propositions, explaining their potential impacts on community rights and resources. The Voter Turnout Workshop provided background and encouraged participants to promote voter turnout through community-centered outreach strategies.

Sunday’s events closed with a Prayer and Memorial Breakfast honoring the contributions of past and current civil rights leaders.

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Activism

Atty Gen Bonta: U.S. Law Mandating Emergency Care to All Patients Faces Threats

The attorney general highlighted that EMTALA is vital for ensuring that no individual is turned away from emergency services based on financial status or insurance coverage. Bonta stated that the law has been a cornerstone of emergency healthcare for decades, providing peace of mind to millions of Americans who might otherwise hesitate to seek urgent medical attention due to cost concerns.

Published

1 day ago

November 3, 2024

Oakland Post

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By Bo Tefu, California Black Media

California Attorney General Rob Bonta emphasized the critical need to protect the Emergency Medical Treatment and Labor Act (EMTALA), mandating that hospitals provide emergency care to all patients regardless of their ability to pay.

In a recent statement, Bonta highlighted the potential threats to this essential legislation amid ongoing discussions about healthcare accessibility in the U.S.

“EMTALA ensures that no one is denied access to emergency medical care, including abortion care, and this federal law is more imperative than ever following the overturn of Roe v. Wade,” said Bonta.

This decision to support the federal government’s case comes at a time when many healthcare providers are facing pressure from rising costs and legislative changes that could undermine existing protections. Bonta called on lawmakers to reinforce EMTALA’s provisions and to combat any efforts aimed at weakening the act, asserting that equitable access to emergency care is a fundamental right.

He urged state and federal governments to ensure that all Americans, particularly marginalized communities, have the necessary access to emergency services without fear of financial repercussions. The brief indicates the coalition’s commitment to healthcare equity, emphasizing that maintaining strong protections under EMTALA is crucial for safeguarding public health.

As discussions around healthcare policy continue, Bonta remains steadfast in promoting initiatives that protect emergency care access, asserting that everyone deserves timely and appropriate medical treatment in emergencies. His efforts align with ongoing legal and advocacy battles to preserve the rights established by EMTALA in the face of evolving healthcare challenges.

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Alameda County

Access Better Health with Medically Tailored Meals – Transforming Health Through Nutrition for Medi-Cal Patients

Launched in 2018, the Medically Tailored Meals pilot program was designed to help Medi-Cal patients with congestive heart failure by reducing hospital readmissions and emergency department visits by providing tailored meals meeting specific dietary needs. The program’s success in improving health outcomes and reducing costly emergency room visits encouraged the Department of Health Care Services (DHCS) to expand the Medically Tailored Meals program to all 58 counties through Medi-Cal transformation and a new set of services called Community Supports.

Published

6 days ago

October 29, 2024

Oakland Post

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The program’s success in improving health outcomes and reducing costly emergency room visits encouraged the Department of Health Care Services (DHCS) to expand the Medically Tailored Meals program to all 58 counties through Medi-Cal transformation and a new set of services called Community Supports.

Medically Tailored Meals are one of 14 new services offered through Medi-Cal that provide members with access to new and improved services to get well-rounded care that goes beyond the doctor’s office or hospital.

Medically Tailored Meals: Overview

Malnutrition and poor nutrition can lead to severe health outcomes, especially among Medi-Cal patients with chronic health conditions. Medically Tailored Meals aim to improve health outcomes, reduce hospital readmissions, and enhance patient satisfaction by providing essential nutrition.

Key Features:

Post-Discharge Delivery: Meals are delivered to patients’ homes immediately following discharge from a hospital or nursing home.
Customized Nutrition: Meals are tailored to meet the dietary needs of those with chronic diseases, designed by registered dietitians (RD) or certified nutrition professionals based on evidence-based guidelines.
Comprehensive Services: Includes medically tailored groceries, healthy food vouchers, and food pharmacies.
Educational Support: Behavioral, cooking, and nutrition education is included when paired with direct food assistance.

Key Benefits:

Address Food Insecurity: Mitigates poor health outcomes linked to food insecurity.

Support Complex Care Needs: Tailored to individuals with chronic conditions.

Improve Health Outcomes: Studies show improvements in diabetes control, fall prevention, and medication adherence.

Patient Testimonial:

“My diabetes has gotten better with the meals. I’ve kept my weight down, and I feel much better now than I have in a long time. I’m one of the people this program is meant for.” — Brett

Eligibility:

Eligible Populations: Eligible Medi-Cal members include those with chronic conditions like diabetes, cardiovascular disorders, congestive heart failure, stroke, chronic lung disorders, HIV, cancer, gestational diabetes, and chronic mental or behavioral health disorders. Also, those being discharged from a hospital or skilled nursing facility or at high risk of hospitalization or nursing facility placement are also eligible.

Service Limitations: Up to two meals per day for up to 12 weeks, extendable if medically necessary. Meals eligible for reimbursement by alternate programs are not covered.

Cost Savings and Improved Health Outcomes:

Health Outcomes: Research indicates a 22% to 58% decrease in emergency department visits and a 27% to 63% decrease in inpatient admissions among Medically Tailored Meals recipients, translating to significant health care cost savings.

Project Open Hand: A Success Story

Project Open Hand has been a leader in providing Medically Tailored Meals, significantly impacting the lives of Bay Area Medi-Cal patients with chronic illnesses. Since its inception, Project Open Hand has delivered nutritious meals to individuals with diabetes, HIV, and other serious health conditions, demonstrating remarkable health improvements and cost savings.

Key Achievements:

Improved Health Outcomes: Project Open Hand’s research found a 50% increase in medication adherence among recipients of Medically Tailored Meals.

Reduced Hospitalizations: Their program showed a 63% reduction in hospitalizations for patients with diabetes and HIV.

Enhanced Quality of Life: Patients reported better health and increased energy levels.

Project Open Hand ensures that each meal is prepared using fresh, wholesome ingredients tailored to meet the specific dietary needs of its clients. By partnering with Medi-Cal managed care plans, Project Open Hand continues to provide life-saving nutrition to those who need it most.

Join Us in Our Mission

You can experience the profound impact of Medically Tailored Meals by joining the Medi-Cal Community Supports services initiative. Your involvement can make a difference in promoting your health through nutrition.

Learn More

For more information about Medically Tailored Meals and how to get involved, call the state’s Medi-Cal Health Care options at 800-430-4263 or contact your local managed care plan.

In Alameda County, Medi-Cal recipients can contact:

* Alameda Alliance for Health: 510-747-4567

* Kaiser Permanente: 855-839-7613

In Contra Costa County, Medi-Cal recipients can contact:
* Contra Costa Health Plan: 877-661-6230

* Kaiser Permanente: 855-839-7613

In Marin County, Medi-Cal recipients can contact:
* Partnership Health Plan of California: 800-863-4155

* Kaiser Permanente: 855-839-7613

In Solano County, Medi-Cal recipients can contact:
* Partnership Health Plan of California: 800-863-4155

* Kaiser Permanente: 855-839-7613
Your health and well-being are your health care provider’s top priority. Medically Tailored Meals are designed to enhance quality of life by advancing health care through the power of nutrition. Experience the benefits today, and take the first step toward a healthier you.