[文集] [专题] [检索] [独立评论] [海阔天空] [矛盾江湖] [全版论坛]

独立评论

所跟帖: aops FDA没有批准这种药物用于新冠   2020-08-05 10:31:51  


作者: 鸡头肉   相信FDA当然没啥错,但你也应该相信耶鲁-_- 2020-08-05 12:40:17  [点击:1790]
毕竟,作为世界顶尖的大学,耶鲁并非浪得虚名。瞧,连老樊这样的同志在强调有医学专家
为 hydroxychloroquine 背书时,也要列举耶鲁的 Harvey Risch 教授,而没有提更早更著
名的医学博士 Stella Immanuel(Stella 有各种外星人DNA进入了人类医学、梦交盗取精子
等出奇的阴谋论见解,估计老樊也不好意思用她的名头来吓唬俺们-_-)。很多人批评美国高
校被“白左”把持,可一旦那里出现了可为他们作支撑的研究结论时,他们总是第一时间屁
颠颠的引用,也不矜持一下-_-

既然耶鲁大学这么厉害,那该大学的其他教授是怎么看这个问题的呢?下面是 Harvey Risch
教授所在的单位发表的声明——既然老樊如此重视耶鲁大学教授的意见,俺们不妨也听听他们
怎么说。



Statement from Yale Faculty on Hydroxychloroquine and its Use in COVID-19


We write with grave concern that too many are being distracted by the ardent advocacy of our Yale colleague, Dr. Harvey Risch, to promote the assertion that hydroxychloroquine (HCQ) when given with antibiotics is effective in treating COVID-19, in particular as an early therapeutic intervention for the disease. As his colleagues, we defend the right of Dr. Risch, a respected cancer epidemiologist, to voice his opinions. But he is not an expert in infectious disease epidemiology and he has not been swayed by the body of scientific evidence from rigorously conducted clinical trials, which refute the plausibility of his belief and arguments. Over the last few weeks, all of us have spent considerable time explaining the evidence behind HCQ research, as it applies to early and late stage COVID-19 patients to the scientific community and general public, and now are compelled to detail the evidence in this open letter.

We are seriously alarmed for the safety of patients and the coherence and effectiveness of our national COVID-19 emergency response when misinformation about HCQ is spread and when rigorous scientific evidence and consensus produced by the community of expert researchers in infectious diseases, federal agencies and national and global health organizations are not heeded. Let us be clear: we are unanimous in our desire to see the development of therapies to treat COVID-19 and to prevent the transmission or acquisition of SARS-CoV-2. If HCQ was shown to be effective, even among subgroups of patients with COVID-19 in ongoing high quality trials, we would join our colleagues in promoting access to it for all who need it. However, the evidence thus far has been unambiguous in refuting the premise that HCQ is a potentially effective early therapy for COVID-19.

HCQ is used for the treatment of rheumatological diseases, such as lupus and rheumatoid arthritis. However, this does not ensure that the drug will be safe in patients with COVID-19 or in widespread use to treat early illness. In fact, rigorously-conducted clinical trials have found that HCQ is not effective as an early prophylactic therapy in preventing illness due to COVID-19 in people exposed to the virus. Furthermore, HCQ, alone or together with the antibiotic, azithromycin, has not been shown to be effective in improving the clinical status of patients with COVID-19. Moreover, clinical trials have found that treatment with HCQ may be associated with increased risk of adverse reactions. Taken together, the scientific evidence does not support the widespread use of this drug, alone or in combination with an antibiotic, as advocated by Dr. Risch and others, unless rigorous evidence from clinical trials demonstrates otherwise.

Finally, we point to the recent memorandum from the US Food and Drug Administration revoking the Emergency Use Authorization for HCQ that has assembled the data on the drug as of June 2020 (Food and Drug Administration Memorandum Explaining Basis for Revocation of Emergency Use Authorization for Emergency Use of Chloroquine Phosphate and Hydroxychloroquine Sulfate). The Infectious Diseases Society of America now advises against the drug alone or in combination with azithromycin in the setting of COVID-19 except in the context of ongoing clinical studies. If these trials do show a clinical benefit for HCQ, we would revise our views on its use in the management of COVID-19.

The disproportionate focus on treatment with HCQ, in addition to the lack of a strong scientific rationale for its use and the risk of its potentially harmful effects, has major opportunity costs. In a recent analysis of COVID-19 clinical trials, one in every six studies of treatments against SARSCoV-2 was designed to study HCQ or chloroquine. We understand the desperation of many to see an effective treatment for COVID-19 emerge that will stop the pandemic in its tracks or slow its relentless spread in the US. But investing our resources in HCQ after multiple studies have not shown it to be effective for COVID-19 has serious implications for more than just individual patients. The continuing advocacy on behalf of HCQ distracts us from advancing the science on COVID-19 and seeking more effective interventions in a time when more than 1000 people are dying per day of this disease. There are multiple approaches to expedite the evaluation and approval of drugs for serious and life-threatening diseases in the US that have existed for decades now, but they all still rely on data from rigorous, well-conducted clinical trials to guide us. In addition, this ongoing promotion of HCQ has global implications as well, as many countries in the global South only have access to HCQ and use of HCQ is still common in this setting despite the lack of evidence and potential risks.

It is critical that we follow the science and where the evidence leads us on a quest to treat and prevent COVID-19. In this climate, it’s important to rely on the data above all else when making clinical or regulatory decisions. Making these kinds of choices guided by personal endorsements outside of the context of the existing scientific evidence is medicine by testimonial and risks people’s lives. Randomized controlled trials are how we keep from fooling ourselves, test our assumptions about new drugs and new uses for old ones. For instance, flecainide was initially proposed as a drug to treat those at risk of severe arrhythmias after sudden myocardial infarction. However, the Cardiac Arrhythmia Suppression Trial showed for the first time that mortality was actually three times higher among persons receiving the drug for this purpose. Even though the drug was known to be effective in those experiencing severe arrhythmia, it ended up increasing mortality in those simply at risk. And no one noticed because sudden death after myocardial infarction was not a rare event and this tripling of the risk was not detected until a randomized, controlled trial was done. The FDA has rescinded the EUA for HCQ for a reason: the vast preponderance of the evidence suggests that the drug is without merit in clinical care for COVID-19 and presents real dangers to patients by its continued use.

In 1987, University of California at Berkeley Professor Peter Duesberg gained notoriety by expounding on his belief that AIDS was not caused by the human immunodeficiency virus, but by antiretroviral agents like azidothymidine (AZT) and recreational drugs. However, the data on antiretroviral therapy was clear: these drugs extended life and health and turned around the course of the AIDS epidemic worldwide. But Professor Duesberg persisted in his quest. Professor Duesberg’s thesis dissuaded many from taking antiretroviral therapy, and after the President of South Africa Thabo Mbeki endorsed these views, it led to delays in the roll-out of these life-saving drugs costing hundreds of thousands of lives in that country. While minority opinions, anecdotal evidence, novel interpretations and challenges to orthodoxies in a field can be important, at some point, the application of the scientific method generating evidence from multiple, well-designed clinical trials and observational studies does matter and should be heard over the noise of conspiracy theories, purported hoaxes, and the views of zealots.


Signed,
Jason Abaluck, PhD
Associate Professor of Economics
Yale School of Management
Amy Bei, PhD
Assistant Professor of Epidemiology (Microbial Diseases)
Yale School of Public Health
Theodore Cohen, MD, DPH
Professor of Epidemiology (Microbial Diseases)
Co-director, Public Health Modeling Concentration
Yale School of Public Health
Gary V. Desir, MD
Paul B. Beeson Professor of Medicine
Vice Provost, Faculty Development and Diversity
Chair, Internal Medicine, Yale School of Medicine
Chief, Internal Medicine, Yale New Haven Hospital
Gail D’Onofrio MD
Professor & Chair, Emergency Medicine
Yale School of Medicine
Yale School of Public Health
Howard P. Forman, MD, MBA
Professor of Radiology & Public Health (Health Policy)
Yale School of Public Health
Yale School of Medicine
Professor in the Practice of Management
Yale School of Management
Alison Galvani, PhD
Burnett and Stender Families Professor of Epidemiology (Microbial Diseases)
Director of the Center for Infectious Disease Modeling and Analysis (CIDMA)
Yale School of Public Health
Gregg Gonsalves, PhD
Assistant Professor of Epidemiology (Microbial Diseases)
Yale School of Public Health
Associate Professor (Adjunct) and Research Scholar
Yale Law School
Nathan D. Grubaugh, PhD
Assistant Professor of Epidemiology (Microbial Diseases)
Yale School of Public Health
Roberta Hines, MD
Nicholas M. Greene Professor & Chair of Anesthesiology
Yale School of Medicine
Valerie Horsley, PhD
Associate Professor of Molecular, Cellular & Developmental Biology
Yale University
Akiko Iwasaki, PhD
Waldemar Von Zedtwitz Professor of Immunobiology and Molecular, Cellular and Developmental Biology
Yale School of Medicine
Professor of Molecular Cellular and Developmental Biology
Yale University
Amy Kapczynski, JD
Professor of Law
Yale Law School
Trace Kershaw, PhD
Department Chair and Susan Dwight Bliss Professor of Public Health (Social and Behavioral Sciences)
Yale School of Public Health
Albert I. Ko, MD
Professor of Epidemiology and Medicine and Chair of Epidemiology of Microbial Diseases
Yale School of Public Health
Stephen R. Latham, JD, PhD
Director, Interdisciplinary Center for Bioethics
Yale University
Brett Lindenbach, PhD
Associate Professor, Microbial Pathogenesis
Yale School of Medicine
Fiona Scott Morton, PhD
Theodore Nierenberg Professor of Economics
Yale School of Management
Saad B. Omer, MBBS MPH PhD FIDSA
Professor of Medicine (Infectious Diseases),Yale School of Medicine
Adjunct Professor, Yale School of Nursing
Susan Dwight Bliss Professor of Epidemiology of Microbial Diseases, Yale School of Public Health
A. David Paltiel, PhD
Professor of Health Policy & Management
Yale School of Public Health
Yale School of Management
Sunil Parikh, MD, MPH
Associate Professor of Epidemiology and Medicine
Yale School of Public Health
Yale School of Medicine
Karen Santucci, MD
Professor & Chief, Pediatric Emergency Medicine
Yale School of Medicine
Marcella Nunez Smith, MD, MHS
Associate Professor, General Internal Medicine, Public Health, and Management
Yale School of Medicine
Yale School of Public Health
Yale School of Management
Director, Equity Research and Innovation Center
Daniel Weinberger, PhD
Associate Professor of Epidemiology (Microbial Diseases)
Yale School of Public Health

加跟贴

笔名:     新网友请先注册笔名 密码:
主题: 进文集
内容: