The studies involving human participants were reviewed and approved by Fourth Military Medical University. Comparison of 2-Octylcyanoacrylate Versus 5-0 Fast-Absorbing Gut During Linear Wound Closures and the Effect on Wound Cosmesis. ZY: concept of the study, designing the study, acquiring data, and writing the manuscript. Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months. FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children. Vaccines and Related Biological Products Advisory Committee Meeting. Would you like email updates of new search results? Following careful review and deliberation, the U.S. Food and Drug Administration is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available. Coronavirus InfectionsMore Than Just the Common Cold Conclusion: No differences in wound healing and scar formation were observed in patients with different COVID-19 vaccination intervals. To account for 25% of dropouts, at least 30 patients were needed to recruit for this study. (A) WAI at 7 d follow-up; (B) POSAS patient scale at three-month follow-up; (C). Figure 2. How do we prevent this? 71 p. 19. Remarks by FDA Commissioner Stephen M. Hahn, M.D.,as prepared for a video conversation with health professionals. 2022 Dec;19(8):2071-2081. doi: 10.1111/iwj.13810. Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses. Please enable it to take advantage of the complete set of features! Human coronaviruses (HCoVs) have long been considered inconsequential pathogens, causing the "common cold" in otherwise healthy people. Figure 3. Zhuang AR, Beroukhim K, Armstrong AW, Sivamani RK, Eisen DB. Many pregnant women have received COVID vaccination without any problems. . : Results of a randomized, split-scar, comparative trial. Promote wound healing High absorbency, supports a moist wound-healing environment, keeps the dressing from adhering to the injury, and promote wound healing. FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age. Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers. Today, FDA announced that it has found certain lots of Astra Zeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. Public health and medical experts from the U.S. Department of Health and Human Services released a statement on the Administrations plan for COVID-19 booster shots for the American people. The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, beginning in Fall 2022. While vaccines are very important, other precautions also help prevent infection, disease, and death, Sehgal . A conversation with Center for Biologics Evaluation and Research director Peter Marks, M.D., Ph.D. FDA In Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines. None of the patient characteristics was statistically different among the three groups [ <1 month (n = 8), 13 months (n = 12), and 3 months (n = 11)] in age, wound causes, wound sites, wound type, wound length, topical silicone application, and laser therapy. FDAs Office of Minority Health and Health Equity discusses the agencys efforts to stop fraudulent products from reaching our markets, especially those claiming to prevent, treat, or cure COVID-19. Risk for chronic wounds in COVID-19 patients In addition to the traditional risk factors for developing wounds (see "Risk factors for impaired wound healing and wound complications"), SARS-CoV-2 is associated with physiologic changes that may affect healing. Di Saverio S, Pata F, Gallo G, Carrano F, Scorza A, Sileri P, Smart N, Spinelli A, Pellino G. Colorectal Dis. Sun Q, Fathy R, McMahon DE, Freeman EE. Dr. Stephen Hahn explains the FDAs role in ensuring safety, effectiveness of COVID-19 vaccines. The FDA published two FDA voices - Give Your Community a Boost: Combatting Misinformation Through Communication and Research and FDAs Technology and Data Modernization in Action in 2022. The FDA also published findings from a facility inspection of Abbott Nutrition in Sturgis, Michigan, revised the guidance: Emergency Use Authorization for Vaccines to Prevent COVID-19, denied two the request in two citizen petitions, published the FDA voices announced the extension of a public comment period, approved a new animal drug, updated a list of which regions in which the drug Sotrovimab is not authorized, approved a medical device to treat defects or legions that can occur in cartilage covering bones in the knee joint, authorized marketing of a medical device for measuring the brain temperature of neonates (infants less than four weeks old) and updated a fact sheet and FAQ regarding dosing information of Evusheld. I'm a disabled woman of color. Today, the FDA began posting materials for the next Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting, happening on Tuesday, Oct. 26. Lindley LE, Stojadinovic O, Pastar I, Tomic-Canic M. Biology and biomarkers for wound healing. The final sentence tells it all, "Wound care matters..Wound care is essential. Negative Pressure Wound Therapy Market . The FDA authorizes an emergency use authorization for one additional batch of the Janssen COVID-19 vaccine and the FDAs Acting Commissioner, Dr. Janet Woodcock, discusses the authorization of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine. See this image and copyright information in PMC. The virus, that would ultimately be known as COVID 19 was declared a pandemic by the WHO on March 11th, 2020. (2016) 138:18S28S. Recently, new-onset autoimmune phenomena after COVID-19 vaccination have been reported increasingly (e.g. Accessibility Unwavering Regulatory Safeguards for COVID-19 Vaccines, FDA commissioner: No matter what, only a safe, effective vaccine will get our approval. Dr. John Mohart commented, The biggest misperception is about fertility issues. (2021) 326:2734. McMahon et al. Remarks by Dr. Hahn to the Global Coalition for Regulatory Science Research, Dr. Hahn's remarks to the National Consumers League on the vaccine review process, Consumer Perspectives on the Covid-19 Pandemic: A Conversation with the FDA, Remarks by Commissioner Hahn to Friends of Cancer Research, COVID-19: An Update on the Federal Response - FDA Opening Remarks. Of note, wound care supplies meant for patient care were reported as being locked away from nursing staff, patients were found sitting in soiled linens for prolonged periods of time, there was improper catheter care, and a high incidence of pressure injuries were observed due to prolonged bed rest and improper bed positioning. Lim DW, Ng D, Low JG. We are in a health care crisis and that requires bravery. On Thursday, FDA approved a single dose vial presentation of COMIRNATY (COVID-19 Vaccine, mRNA). FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19. The public may be concerned that COVID-19 vaccination will cause side effects similar to viral infections mentioned above to affect wound healing and even lead to hypertrophic scar formation. Bookshelf *Correspondence: Zhou Yu, yz20080512@163.com; Xianjie Ma, majing@fmmu.edu.cn, COVID-19 Vaccines Safety Tracking (CoVaST): part I, View all
Do they take the risk of exposing their patients to the virus, or do they continue with the much-needed wound care?, From the November 2020 Issue of McKnight's Long-Term Care News. This site needs JavaScript to work properly. Epub 2018 Sep 30. Acting FDA Commissioner, Janet Woodcock, M.D. Today, the U.S. Food and Drug Administration announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (booster) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older. This vaccine has been the only thing that gives us hope to get up in the morning and do it for a few more months. Joint CDC and FDA Statement on Vaccine Boosters. doi: 10.1016/j.jaad.2021.03.092, 14. All patients were diagnosed with simple and open skin injuries, which eliminated interference with the results by other comorbidities. Patients with COVID-19 and non-healing wounds have much in common, access to care might not be one of them, reports American College of Wound Healing and Tissue Repair News provided by. An FDA staff memberdiscusses how her former hesitancy and fear grew into hope and a willingness to receive a COVID-19 vaccine. A: Individuals may receive a single booster dose of one of the authorized bivalent mRNA COVID-19 vaccines, when eligible, as follows: Children who are 6 months through 5 years of age who received . The FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to take several actions that will expand the use of the vaccine in certain populations. Plast Reconstr Surg. The feeling was a massive shift from what has been a hopeless and oppressive energy as we have dealt with tremendous amounts of illness and death. Kappel S, Kleinerman R, King TH, Sivamani R, Taylor S, Nguyen U, Eisen DB. This is a Light Language Transmission that assists in relevant COVID related concerns, including vaccine remorse and damage to the Light Body and Genes. COVID-19; COVID-19 vaccine; plastic surgery; scar formation; vaccination; vaccine hesitancy; wound healing. ATTENTION: Si vous parlez franais, des services d'aide linguistique vous sont proposs gratuitement. Dr. John Mohart added his thoughts on the most compelling reasons for co-workers to take action and get the vaccine. XM: concept of the study, designing experiments, and writing and editing the manuscript. The doctors explained why each of these fears are untrue. Update: The FDA updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in dark blue packaging is a product of ACON Biotech (Hangzhou) Co., Ltd. FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age. Careers. FDA Will Follow The Science On COVID-19 Vaccines For Young Children. No Differences in Wound Healing and Scar Formation Were - PubMed ", Health Fraud & COVID-19: What You Need to Know. Im proud of them and proud to have been part of this process, even though it was painful. BMC Surg. The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss Emergency Use Authorization (EUA) of the Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older. The Committee will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. 1-844-802-3925 . One surgeon performed the surgeries, which avoided the bias of different surgical techniques. First, the follow-up to determine scar formation ended at 3 months because of the widespread prevalence of booster doses on the Chinese mainland. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). The vaccine developers report that some people experience pain where they were injected; body aches; headaches or fever, lasting for a day or two. Conclusion: No differences in wound healing and scar formation were observed in patients with different COVID-19 vaccination intervals. 2020 Nov 3;20(1):268. doi: 10.1186/s12893-020-00932-3. This week, the FDAs Vaccines and Related Biological Products Advisory Committee is meeting to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. Bonnet JB, Macioce V, Jalek A, Bouchdoug K, Elleau C, Gras-Vidal MF, Pochic J, Avignon A, Sultan A. Diabetes Metab Res Rev. The position paper proposes solutions, recognizes the amazing care being rendered by healthcare professionals treating COVID patients and restates the mission of the college which is to create specialty status for wound care. COVID-19 Vaccine Offers Hope and Healing | Mercy FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting. Feature Article: Viral Shedding and COVID-19 What Can and Can't Wound healing and scar formation were rated according to the Wound Assessment Inventory (WAI) and Patient and Observer Scar Assessment Scale (POSAS) in the groups at 7 days and after a 3-month follow-up. The hardest part of the pandemic is that its almost the exact same population that is most vulnerable to complications from COVID-19 that is most need of wound care, wrote Brian Wallace, founder and president of Louisville-based NowSourcing, an infographic design agency, in a recent McKnights.com blog. On March 4, the FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from six to nine months, allowing the product to be stored at 2-8 degrees Celsius. (A) edema; (B) erythema; (C) exudates. and the Director of FDA's Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the suggested increased risks of myocarditis and pericarditis following COVID19 vaccination. Also, the standard deviation (SD) of each group was 5. = 2, = 0.05, and = 0.2. The vaccination interval was defined as the interval between the last dose of the COVID-19 vaccine and when surgical sutures were introduced. A crisis like this shows you how remarkable people are. Nature. Figure 4. PAUNAWA: Kung nagsasalita ka ng Tagalog, maaari kang gumamit ng mga serbisyo ng tulong sa wika nang walang bayad. 85% of our Mercy physicians have already received the vaccine because theyre listening to the science., Dr. John Mohart continued by sharing the urgency of the situation in terms of the vaccines availability, As health care workers, weve had a monopoly on access to the vaccine, but those days are coming to an end. The main types of COVID-19 vaccines currently available in the U.S. or being studied include: Messenger RNA (mRNA) vaccine. COVID-19 vaccines and the skin: the landscape of cutaneous vaccine reactions worldwide. MIAMI, Florida ( WSVN) -- A burrowing owl is on the mend after suffering a bad injury when it got stuck in a storm shutter. The phones are ringing off the hooks from patients wanting the vaccine, so the demand will soon greatly outstrip our supply.. FDA Authorizes COVID-19 Vaccine in Children 5 through 11. Results of a clinical trial. Would you like email updates of new search results? The FDA updated the Pfizer-BioNTech emergency use authorization (EUA) to support the extension of shelf-life of the Pfizer-BioNTech COVID-19 Vaccine stored at -90 degrees to -60 degrees Celsius from 6 months to 9 months. As part of the FDAs commitment to transparency, we invite you to watch our virtual press conference, to be live streamed over the FDAs YouTube, Facebook and Twitter accounts on December 12, 2020, at 9:00 AM ET. Dressings may not have been changed as frequently as they should have been, or they may have been improperly changed, increasing the risk of infection, she noted. The American College of Wound Healing and Tissue Repair, a not for profit 501c3 organization, has posted a position paper on this subject. By Akshay Syal, M.D. View press briefing. This study was performed in accordance with the ethical standards of our institution and the 1964 Declaration of Helsinki. Most cutaneous reactions after COVID-19 vaccination lasted no more than 30 days (13). Al Jurdi A, Gassen RB, Borges TJ, Solhjou Z, Hullekes FE, Lape IT, et al. If vaccination causes shedding, it typically results . Recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19. Vaccines. A CTV News article published in 2020, Man rotting alive from bedsore dies of infection, revealed the high incidence of pressure injuries in long term care (LTC) residents. Methods: In this study, patients with adult trauma with subcutaneous sutures placed by a single plastic surgeon in a single center were included. The integration of NSWOCs and SWANs into existing health care teams will improve health care outcomes of patients and improve upon the safety and well-being of Ontarios vulnerable LTC population and while reducing hospital admissions for WOC related issues. Reactivation of BCG vaccination scars after vaccination with mRNA-Covid-vaccines: two case reports. Age-related immune response heterogeneity to SARS-CoV-2 vaccine BNT162b2. (2004) 113:19605; discussion 19667. and the Director of FDA's Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. were featured speakers. Yet the global picture of access to COVID-19 vaccines is unacceptable. The study analyzes which people have Stress and anxiety with Wound infection. The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, et al. (2014) 67:101725. and more urgently, Who do we call who knows how to fix this?. J Plast Reconstr Aesthet Surg. doi: 10.1177/15347346221078734, 24. (2019) 39:NP26678. This was in response to the growing need in Canada for healthcare professionals with enhanced WOC knowledge and the as a means to support and empower NSWOCs and improve clinical outcomes by enhancing WOC care teams. Integrating telemedicine into wound care during the outbreak helps maintain social distancing, preserve personal protective equipment and medical resources, and eliminate unnecessary exposure for both vulnerable patients and high-risk healthcare workers. The need is clear, and the proof is in the numbers: A Nurse Specialized in Wound, Ostomy, and Continence (NSWOC), formally known as an Enterostomal Therapist, is a practitioner trained specifically to provide advanced specialized care for patients with wounds, ostomies, and continence issues. Its the first time we can take back control so we can continue doing the things we love to do. The FDA posts an updated letter of authorization, health care provider fact sheet and frequently asked questions regarding the number of Pfizer-BioNTech doses in a vial, updated the Device Shortage List, and provides a testing update. All other trademarks are the property of their respective owners. Molecular mimicry, the production of particular autoantibodies and the role of . and transmitted securely. National Library of Medicine Beneficial Effects of Dinitrosyl Iron Complexes on Wound Healing COVID-19 Vaccines - WebMD At the 36-month interval, the level of neutralizing antibodies against COVID-19 plateaued and gradually decreased (14, 15). The committee will discuss the Emergency Use Authorization (EUA) of the ModernaTX Inc. COVID-19 vaccine and the Janssen Biotech Inc. COVID-19 vaccine for the administration of an additional dose, or booster dose, following completion of the primary series, to individuals 18 years of age and older. The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc. Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants. ATENCIN: si habla espaol, tiene a su disposicin servi cios gratuitos de asistencia lingu.stica. The FDA announces revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine. The investigators examined the NHS records of 32 million adults in England to assess any rare adverse events linked to Covid vaccines. Can medical hypnosis accelerate post-surgical wound healing? Face Masks COVID-19 Test Kits COVID-19 Medication Immune Support Book your COVID-19 Vaccine COVID-19 Vaccine Digital Record. Why you cannot 'detox' from COVID-19 vaccines - Medical News Today Epub 2020 Apr 20. View October 15 livestream. The FDA takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. Until now, no evidence-based study has been published regarding how soon patients can undergo plastic and aesthetic surgery after receiving the COVID-19 vaccine and whether the COVID-19 vaccine affects wound healing and scar formation. Background: On May 14th, 2020, the military produced a report highlighting the atrocious and inhumane living conditions of our most vulnerable population. An internal Nurses Specialized in Wound, Ostomy and Continence Canada report confirms this gap in care as only 69 NSWOCs reported providing care support to LTC clients in Canada while only 20 of those NSWOCS are solely dedicated to work in LTC. (2021) 27:2258. All authors contributed to the article and approved the submitted version. Today, the FDA issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19. Thus, it is not necessary to postpone COVID-19 vaccination, as the vaccine does not affect wound healing and scar formation in patients undergoing surgery. The Jan. 13 Supreme Court of the United States decision that the Centers for Medicare & Medicaid Services federal COVID-19 vaccine mandate will move forward requires UPMC to ensure employees either get vaccinated or receive a requested medical or religious exemption. OBAVJETENJE: Ako govorite srpsko-hrvatski, usluge jezike pomoi dostupne su vam besplatno. Unauthorized use of these marks is strictly prohibited. No use, distribution or reproduction is permitted which does not comply with these terms. The single-dose vials have gray caps and labels with gray borders, and the vaccine must not be diluted before use. Bertossi D, Dell'Acqua I, Albanese M, Marchetti P, Nocini P. Face treatment using nonsurgical mini-invasive techniques as postsurgical procedure for traumatic injury. The doctors continued by discussing several myths that have been circulating. We're debunking the biggest myths at Mercy, one topic at a time. Thus, it is not necessary to postpone COVID-19 vaccination, as the vaccine does not affect wound healing and scar formation in patients undergoing surgery. Polio, as an example, had a devastating effect on peoples lives prior to the vaccine. Safety concerns are one of the most common reasons for COVID-19 vaccine refusal (21). Karmisholt KE, Banzhaf CA, Glud M, Yeung K, Paasch U, Nast A, Haedersdal M. Br J Dermatol. Experts also are beginning to echo concerns that providers pandemic response to the virus itself could be impeding wound care practice. Epub 2021 Oct 29. Metaphorically, we are in the darkest days of winter, but were headed into a spring and summer that gives us a light at the end of the tunnel. The FDA authorized the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. Euro Surveill. -, Lazarus JV, Ratzan SC, Palayew A, Gostin LO, Larson HJ, Rabin K, et al. FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines. Today, the FDA authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age. He added that the government is "committed to ensuring that vaccines and treatments are accessible and not prohibitively expensive for uninsured Americans," but did not provide further . In December of 2019 the World Health Organization (WHO) was informed of an unknown virus causing pneumonia like symptoms in Wuhan City, Hubei Province of China. Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Director of the FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. testifies for the FDA. COVID-19 Update: FDAs Ongoing Commitment to Transparency for COVID-19 EUAs. Coronavirus Disease 2019 (COVID-19), Recalls, Market Withdrawals and Safety Alerts, COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders, COVID-19 Vaccines Approved or Authorized for Emergency Use, COVID-19 Vaccine Boosters and COVID-19 Vaccines for Kids, Letter to Health Care Personnel and Facilities, Emergency Use Authorization for Vaccines Explained, The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF-723KB), Oversight of the Trump Administrations Response to the COVID-19 Pandemic, An Emerging Disease Threat: How the U.S. Is Responding to COVID-19, the Novel Coronavirus, The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723KB), The Path for Vaccines from Research to FDA Approval, COVID-19 Vaccine Boosters: Getting the Facts Straight, The Emergency Use Authorization (EUA) Process, How FDA Collaborated on COVID-19 Vaccines, Center for Biologics Evaluation and Research (CBER), Development and Licensure of Vaccines to Prevent COVID-19, Emergency Use Authorization for Vaccines to Prevent COVID-19, Vaccine EUA Questions and Answers for Stakeholders, Required Reporting of Vaccine Side Effects.
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