Tag: Advisory

 

Advisory Panel Balks at Neovasc Reducer for Refractory Angina

More than 10 hours of testimony and debate failed to convince a US Food and Drug Administration (FDA) expert advisory panel that existing evidence reasonably supports a premarket approval (PMA) application for the Neovasc Reducer device.

The Reducer is intended for people suffering from refractory angina pectoris despite guideline-directed medical therapy, who are unsuitable for revascularization by coronary bypass grafting or percutaneous coronary intervention.

The FDA’s Circulatory System Devices Panel advisory committee generally agreed in a 14-to-4 vote that the evidence provides reasonable assurance the Reducer is safe, but took a dim view on assurances of its effectiveness in a vote of 1 to 17.

On the question of a benefit/risk ratio, the vote was 3 yes, 13 no, and 2 abstentions. The panel did not vote on the approval of the PMA itself but heard several impassioned pleas from patients calling for its approval in the United States.

“People talked about the urgent need and the patients need hope, but we shouldn’t give them false hope,” Richard Page, MD, University of Vermont Medical Center, South Burlington, said. “We need to provide them something we truly believe is going to be effective and that was not proven today.”

Erik Magnus Ohman, MD, Duke University School of Medicine, Durham, North Carolina, who voted no on all three counts, said, “I voted no for efficacy because I couldn’t link ischemia, which is objective, with a device that we put in permanently when nearly half the patients had very little treatment benefit.”

The primary data set in support of the PMA was from the phase 2 COSIRA study, in which 18 of 52 patients treated with the Reducer and 8 of 52 patients treated with a sham procedure had improved by at least two Canadian Cardiovascular Society (CCS) classes, the primary efficacy outcome, at 6 months (34.6% vs 15.4%, P = .024). 

In 28.8% of the Reducer group and 57.7% of the control group, no change in CCS was seen.

“This is an angina study and for 50 years the standard for angina for success or magnitude of success in minimizing or preventing angina has been a quantitative exercise test, but that’s not what we’re talking about here,” Jeffrey Borer, MD, SUNY Downstate Health Sciences University in Brooklyn, New York, said. “We’re talking about a subjective endpoint and I think that’s a real problem and just magnifies all the other problems that have been discussed.”

Several panelists questioned whether the trial truly enrolled patients with CCS class 3 or 4 angina with limited options, given that 27% of Reducer patients and 25% of controls were on none or one antianginal medication. Information was also not provided about compliance or whether patients were on therapeutic or maximally tolerated doses.

Others pointed out the potential for a placebo effect and that patients were largely satisfied with treatment despite the marked discrepancy in results. Also, the trial lacked a formal blinding assessment for investigators.

Wayne Batchelor, MD, Inova Heart & Vascular Institute, Fairfax, Virginia, took issue

US faces major hurdles for COVID-19 vaccine distribution: Vaccine advisory committee

Any coronavirus vaccine that could be authorized for emergency use by the U.S. Food and Drug Administration (FDA) faces several additional hurdles after completing the final stage of clinical trials.

That was the theme of key issues addressed today by the FDA’s vaccine advisory committee — which includes a group of health and science experts who advise the regulatory agency on the best way to approach the path forward for a COVID-19 vaccine.

Among the more immediate hurdles, the path to receive an emergency use authorization remains somewhat murky for the pharmaceutical industry, as the agency has not nailed down specifics for things such as labeling and what qualifies as sufficient monitoring of individuals who have enrolled in clinical trials.

Trial kits for Pfizer coronavirus disease (COVID-19) vaccination study are seen at the Research Centers of America, in Hollywood, Florida, U.S., September 24, 2020. REUTERS/Marco Bello
Trial kits for Pfizer coronavirus disease (COVID-19) vaccination study are seen at the Research Centers of America, in Hollywood, Florida, U.S., September 24, 2020. REUTERS/Marco Bello

In separate letters to the committee, Pfizer (PFE), Johnson & Johnson’s (JNJ) Janssen and trade group BIO all asked for more clarity on the follow-up period for participants following the final dose of the vaccine.

J&J wrote that the current guidelines ask for 50% of the trial population to be monitored for two months following the final dosing. With J&J enrolling 60,000 participants, and other competitors only enrolling 30,000, that provides an uneven playing field.

“Specifying a minimum required follow-up in terms of subjects and months … would ensure consistency across all studies,” the company wrote.

Another concern is what happens to trial participants — especially in a placebo group — after an emergency use authorization is awarded. The FDA’s guidelines require that the placebo group is maintained so that collection of data for safety and efficacy continues on through until the vaccine can be fully approved — especially since the vaccine would still be considered “investigational” at the point.

Pfizer had said it anticipates offering the vaccine to the placebo participants once it receives an emergency use authorization (EUA) — which is an ethical obligation, according to BIO.

“Additional discussion is needed to determine how placebo-controlled trials can be maintained after an EUA is granted. As an industry, we have an ethical obligation to make our trial participants aware that a vaccine may be available,” wrote BIO’s senior director of infectious disease policy Gregory Frank.

FDA’s deputy director of vaccines, Doran Fink, said the trial has to remain blinded because that isn’t a step that can be walked back and it could jeopardize the integrity of the massive trials.

When asked what can be done to ensure that participants don’t simply then drop out of the trial or choose to take the vaccine, Fink said the FDA had no idea and is asking the companies to figure it out and describe their plan in any emergency use authorization filings.

Distribution and administration

What happens after an EUA is also of concern, as the distribution process for two frontrunners — Moderna (MRNA) and Pfizer — requires extra cold temperatures. While Moderna has

Cleveland Boil Water Advisory Issued After Water Main Break In Richmond Hill

Following a large transmission water main break on Saturday night in Richmond Hill, Cleveland has issued a boil water advisory for residents in several cities.

The Cleveland Water Department stated that the advisory was issued because disease-causing organisms may have entered the state’s water system in some Northeast suburbs as a result of the water main break.

Residents in Richmond Heights, Gates Mills, Lyndhurst, Highland Heights, South Euclid, Mayfield, and Mayfield Heights should expect to be under the advisory through Monday morning.

Locals are advised to refrain from drinking water without flushing and boiling it first. All tap water that is used for should be flushed out for at least three minutes. Water should be brought to a boil for at least one minute before it is removed from the stove to be cooled. Residents could also drink bottled water until the advisory has been lifted.

Ignoring the advisory could result in waterborne illness, which could include stomach discomfort and nausea. Those with severely compromised immune systems such as the elderly and infants may be at increased risk and should speak to health care providers before consuming water during the advisory.

Although there is a boil water advisory in effect, officials cannot confirm whether the state’s water supply has been tainted following the water main break.

“Cleveland Water has no evidence at this time that the water system is contaminated. The possibility, however, does exist that the water system is contaminated and is issuing this advisory as a precaution,” the press release stated.

A truck drives through floodwaters in Lake Charles, Louisiana on October 10, 2020 following Hurricane Delta A truck drives through floodwaters in Lake Charles, Louisiana on October 10, 2020 following Hurricane Delta Photo: AFP / CHANDAN KHANNA

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Florida Cancer Specialists Oncologist Michael Diaz, MD Appointed to Florida Cancer Control & Research Advisory Council (CCRAB)

Council Advises State on Ways to Reduce the Burden of Cancer in Florida

Vice President & Assistant Managing Physician Michael Diaz, MD
Vice President & Assistant Managing Physician Michael Diaz, MD
Vice President & Assistant Managing Physician Michael Diaz, MD

Fort Myers, Fla., Oct. 16, 2020 (GLOBE NEWSWIRE) — Michael Diaz, MD, Assistant Managing Physician of Florida Cancer Specialists & Research Institute (FCS), has been appointed to a two-year term on the prestigious Florida Cancer Control & Research Advisory Council (CCRAB). Established in 1979 by the Florida Legislature, CCRAB is an advisory body that concentrates on the study of cancer and advises the Legislature, Governor and Surgeon General on ways to reduce Florida’s cancer burden. There are 15 members of the Council, each representing a specific group of stakeholders. Dr. Diaz will serve as the new Association of Community Cancer Centers appointee.

“I am truly honored by this appointment,” Dr. Diaz said. “The Council has a significant leadership role in statewide efforts to improve patient participation in research and to reduce cancer health disparities, two objectives I consider vitally important. I look forward to working with the Council to reduce Florida’s cancer burden and promote healthier lives and communities across the state.”

CCRAB’s top goals for 2020 – 2025 include increasing collaboration among cancer control stakeholders, ensuring collection of comprehensive and high-quality cancer-related date, reducing the incidence and mortality from tobacco-related cancers, eliminating cervical cancer by increasing vaccination against human papillomavirus (HPV), decreasing the incidence of skin cancer and increasing the use of genomic cancer risk assessments, including genetic counseling and appropriate genetic testing.

The Florida Cancer Control & Research Advisory Council traditionally meets twice a year and all meetings are open to the public. The next meeting will be held virtually on Friday, October 23rd from 10:00 AM to 3:00 PM. Additional meeting information will be posted online at CCRAB.org/events.

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About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com)

Recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. Over the past 5 years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with Florida Cancer Specialists participation.* Trained in such prestigious medical schools and research institutes as Duke, Stanford, Harvard, Emory, MD Anderson, and Memorial Sloan Kettering, our physicians are consistently ranked nationally as Top Doctors by U.S. News & World Report.

Florida Cancer Specialists has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies, and advanced treatments, including targeted therapies, genomic-based treatment, and immunotherapy. Our values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians, and staff.

*Prior to approval

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CONTACT: Shelly Glenn Florida Cancer Specialists (770) 365.6168 SGlenn@FLCancer.com Michelle Robey Florida Cancer Specialists (813) 767-9398 Michelle.Robey@FLCancer.com

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