Associated Press: Public safety advocates are asking the federal government to strengthen warnings on Pfizer's anti-smoking drug Chantix, even as the drugmaker prepares to argue that a bold-letter warning about psychiatric problems should be removed from the medicine's label. Continue reading
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Safety Advocates Seek Stronger Warnings on Chantix
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Comments on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications
October 14, 2014. We oppose the draft guidance as written and strongly urge the FDA to rewrite it. The current draft guidance relies on vague wording and subjective judgments, not science or technological assessments. When it is more specific, it promotes the use of surrogate endpoints and the risk tolerance of a small number of patients whose views come to the FDA’s attention. Continue reading
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Comments on De Novo Classification Process
October 14, 2014. As members of the Patient, Consumer, and Public Health Coalition, we have serious reservations about the use of the de novo classification process for implants, life-sustaining, and life-saving devices. We believe that all such high-risk devices should be Class III devices reviewed through the more rigorous PMA process. Continue reading
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Antibiotic resistance: Will policymakers resist effective strategies?
AAAS: One of the most pressing scientific issues facing Congress today is the risk that antibiotic resistance presents to human health. Unfortunately, there is an enormous gap between what the science tells us is needed and the Congressional approach. Continue reading
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Is Early Stage Medical Device Development Going Overseas?
By Harold Bishop, Wolters Kluwer Law & Health Blog October 15, 2014 Even though the FDA has recently proposed a new program to provide earlier market access to high-risk medical devices, FDA Commissioner Margaret Hamburg nevertheless came under fire … Continue reading
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Testimony of Dr. Laurén Doamekpor Before the FDA Advisory Panel on Chantix
The sponsor identified 5 observational studies and 2 meta-analysis studies showing no statistically significant differences in various psychiatric adverse effects between Chantix and other smoking cessation drugs. The sponsor suggests that this evidence supports the removal of the boxed warning for serious psychiatric adverse events. From a scientific and public health standpoint, these studies do not provide an assurance of safety that patients need and deserve. We strongly urge you to recommend that the FDA keep a strongly worded black box warning and delete the misleading conclusions regarding the meta-analyses from the Chantix label Continue reading
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Pfizer Loses a Bet on Removing Serious Warnings From its Chantix Pill
The Wall Street Journal: In a setback for Pfizer, an FDA advisory panel yesterday voted overwhelmingly to maintain the most serious warnings on its Chantix smoking cessation pill. Continue reading
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What you need to know about Ebola
With the Ebola situation changing daily, here’s what you need to know to stay safe. What is it? What are the symptoms? How does it spread? Find out here. Continue reading
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Comments on FDA Safety and Innovation Act Action Plan
October 21, 2014. We strongly support inclusion of separate analysis of safety and effectiveness for demographic subgroups in clinical trials for drugs and devices. It is essential that methodologically sound data about how drugs and devices work in these groups be conducted and made publicly available. Continue reading
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Everything You Need to Know About This Year’s Flu Shot
It’s that time of year again – time to get your flu shot! Read about it here. Continue reading
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Statement of Diana Zuckerman, PhD at FDA Joint Public Advisory Committee Meeting on Chantix
October 16, 2014. We strongly urge you to urge the FDA to keep the black box warning to protect patients and that you strengthen rather than weaken that boxed warning. And, since the meta analyses are fatally flawed, as I and others have pointed out, the FDA should delete the misleading meta-analyses info from the Chantix label. Continue reading
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Comments on Internet/Social Media Platforms Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
October 29, 2014. We welcome the opportunity to provide feedback on this draft guidance regarding use of internet and social media platforms for communicating about medical products. Patients and consumers increasingly rely on social media and the internet as sources of health and medical information that influence their decisions to seek medical care. Continue reading
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Testimony of Dr. Laurén Doamekpor Before the FDA Risk Communication Advisory Committee on fish consumption
November 3, 2014 Good afternoon. My name is Dr. Laurén Doamekpor, and I am a senior fellow at the National Center for Health Research. Our non-profit research center is dedicated to improving the health and safety of adults and children … Continue reading
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Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices
The US Food and Drug Administration (FDA) approves about 400 implanted medical devices each year through an abbreviated process called the 510(k) process, which only rarely requires clinical trials (studies of patients). Continue reading
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Records: Essure birth control maker, Conceptus, cited for malfunctioning, not reporting complaints
WXYZ Detroit: The 7 Investigators obtained records from the Food and Drug Administration (FDA) showing that the original manufacturer of a permanent birth control device, Essure, knew patients were being harmed by the device more than a decade ago. Continue reading
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A Cure for Peanut Allergies?
Food allergies are on the rise, making school, traveling, and even birthday parties risky business for many children. However, there might be a cure: in a 2014 study of Oral Immunotherapy treatment (OIT), over 80% of participants were able to eat the equivalent of about five peanuts after OIT. Continue reading
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Diagnosing and Treating Lyme disease: The First Sign is not always a rash
By Margaret Dayhoff-Brannigan, PhD November 2014 Lyme disease infects approximately 300,000 people each year. Unfortunately, less than 50% of these people will develop the bull’s-eye rash that is the well-known early sign of the disease. Lyme disease is commonly misdiagnosed … Continue reading
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How to Prevent Falls in Older People
The leading cause of injuries in older adults is falling. Falls can lead to loss of independence, early admission into long-term care facilities, disability, and even death. Learn how to prevent them before they happen. Continue reading
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Testimony of Dr. Anna Mazzucco before the EPA Scientific Advisory Panel
December 3, 2014. Research has implicated endocrine-disrupting chemicals in cancer, infertility, and other health problems. We must be able to quickly identify such agents in order to prevent them from entering our food and environment, and from affecting our health for generations to come. Continue reading
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It’s open enrollment season – now what?
By Laurén A. Doamekpor December, 2014 In case you hadn’t noticed, open enrollment season is upon us! Open enrollment is the time every fall when you have the chance to either stick with your old health insurance plan or pick … Continue reading
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