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Article 1

Question

Are there any ethical issues in these studies? 300 words no plagiarism please

Antibodies from convalescent plasma may help those with severe infections

NEW YORK – New York Blood Center (NYBC) will be the first blood center to collect blood plasma donations from people who have recovered from COVID-19 to treat other patients with advanced illness. In the treatment, known as convalescent plasma, the patient is transfused with the donor’s plasma with the goal of using the donor’s antibodies to help clear the virus more rapidly. Yesterday, the U.S. Food and Drug Administration (FDA) approved the treatment for use on a case by case basis and NYBC will be the first to collect plasma from recovered COVID-19 patients for this purpose.

“We’re proud to partner with leading medical institutions from New York and beyond in developing this potential treatment,” said Beth H. Shaz, MD, Chief Medical and Scientific Officer at New York Blood Center. “If this treatment proves to be effective, we are prepared to quickly scale our process and activate our network to serve hospitals nationwide.”

NYBC will collect the donations, process the plasma for infusion, and maintain a bank for hospitals to treat patients with serious or immediately life-threatening COVID-19 infections. Qualified donors will be referred to NYBC by area hospitals and the Food and Drug Administration (FDA) will approve patients for the treatment on a case-by-case basis.

NYBC is one of the largest independent blood centers in the world. Its network serves local communities in New York, New Jersey, Connecticut, Pennsylvania, Delaware, Maryland, Virginia, Missouri, Kansas, Minnesota, Nebraska and Rhode Island. NYBC is prepared to expand convalescent plasma collections across these locations if it proves to be successful.

Article 2

Question

Write a two sentences summary of the below article (In your own words)

Background: Each year many new prescription drugs are approved by the Food and Drug Administration (FDA). The process of developing and bringing new drugs to market is important for primary care physicians to understand.
Methods: We describe the drug development process based on a review of the literature and Web sites addressing FDA processes and policies.
Results: The process starts with preclinical testing. For drugs that appear safe, an investigational new drug application is filed with the FDA. If approved, clinical trials begin with phase 1 studies that focus on safety and pharmacology. Phase 2 studies examine the effectiveness of the compound. Phase 3 is the final step before submitting a new drug application (NDA) to the FDA. An NDA contains all the information obtained during all phases of testing. Phase 4 studies, or postmarketing studies, are conducted after a product is approved. Recent changes in legislation have streamlined the approval process. Critics contend that these changes have compromised public safety, resulting in the need to recall several products from the market. Proponents claim that changes in the approval process help patients with debilitating diseases, such as acquired immunodeficiency syndrome, that were previously denied critical medication because of bureaucratic regulations.

Introduction

The Food and Drug Administration (FDA) is responsible for assuring that foods and cosmetics are safe and that medicines and medical devices are both safe and effective. To carry out this responsibility, the FDA monitors more than $1 trillion worth of products, representing about $0.25 of every $1.00 spent annually by American consumers.^[1] Balancing the efficacy and safety of these products is the core public health protection duty of the FDA. This mission requires examining efficacy as determined from well-controlled trials, effectiveness as determined from actual use in uncontrolled settings, and safety for both prescription and over-the-counter pharmaceuticals before approving a medication for market. During the past decade alone, more than 500 new prescription drugs have been approved by the FDA.

Physicians face the continual challenge of learning about new products approved by the FDA. The process of developing new drugs and bringing new drugs to market has important practice implications yet is poorly understood by most primary care physicians. Understanding how clinical trials are conducted is important when physicians consider the use of a new medication for patients in their own practices. For example, the medical literature or a pharmaceutical representative might refer to a phase 3 or phase 4 study. provides a brief description of these terms and others used throughout this article. Understanding these terms will help the physician understand the risks involved in using a new medicine and the role of clinical trials in evaluating safety and effectiveness. Primary care physicians who might receive invitations to participate in clinical trials need to understand the risks involved for patients and the importance such investigations play in determining efficacy and safety issues of newly released medications. Finally, physicians who challenge the cost of new medications might benefit from a more complete understanding of the time, cost, and complex issues involved in having a new product approved by the FDA.

Answer 1

ARTICLE 1) convalescent plasma containing neutralizing antibody was followed by an improvement in clinical status.These preliminary findings raise the possibility that convalescent plasma transfusion may be helpful in the treatment of critically ill patients with COVID-19 and ARDS, but this approach requires evaluation in randomized clinical trials.

Coronavirus disease 2019 (COVID-19) is a pandemic with no specific therapeutic agents and substantial mortality. It is critical to find new treatments.

To determine whether convalescent plasma transfusion may be beneficial in the treatment of critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

patients who were critically ill with COVID-19 were treated with convalescent plasma. As assessed by Ct, viral load declined within days of treatment with convalescent plasma, and the clinical conditions of these patients improved, as indicated by body temperature reduction, improved Pao2/Fio2, and chest imaging. Four patients who had been receiving mechanical ventilation and ECMO no longer required respiratory support by 9 days after plasma transfusion.

Previous studies have reported the use of convalescent plasma transfusion in the treatment of various infections.6,10,16 For example, patients (n = 50) with SARS had a significantly higher discharge rate by day 22 following onset of illness (73.4% vs 19.0%; P<.001) and lower case-fatality rate (0% vs 23.8%; P = .049) in the convalescent plasma treatment group (n = 19 patients) when compared with steroid treatment group (n = 21).17 In another study of 93 patients with influenza A(H1N1), patients who received convalescent plasma treatment (n = 20) compared with those in the control group (n = 73) had significantly fewer deaths (20% vs 54.8%; P = .01) and a lower median lymphocyte count on ICU admission.

ARTICLE 2) For decades, the FDA has been deeply committed to helping facilitate access to investigational medical products for patients with serious or immediately life-threatening diseases, while also protecting patients and helping them to be able to make informed decisions with their physicians.on,

FDA support Expanded Access and are exploring ways to make it easier for patients, their families and health care professionals to understand the process and how to access investigational therapies.