Covid-19: Epidemiology Update, and the Tenuous Balance between Speed and Safety in the Pandemic

In this UCSF Medical Grand Rounds presentation (June 11, 2020), UCSF experts provide an update on the epidemiology for COVID-19 and the next phase of the pandemic. They also highlight the shift to speed in publications and the FDA approval process – raising the question of whether safety is being compromised. The session is hosted by UCSF Department of Medicine chair Bob Wachter.

Program
Bob Wachter: Introduction
00:05:41 – George Rutherford, Professor, Dept. of Epidemiology & Biostatistics, UCSF; Director of the Prevention and Public Health Group – Update in Epidemiology and the New Phase of the Pandemic
00:22:53 – Q&A
00:29:37 – A panel discussion with Dr. Rutherford and the speakers below – The Shift to Speed in Publications and the FDA Approval Process: An Appropriate Response to a Pandemic or Setup for Errors?
• Rob Califf, Director of Medical Strategy and Policy, Verily and Google Health; former Commissioner of the US Food & Drug Administration; and Founding Director of the Duke Clinical Research Institute (DCRI)
• Vinay Prasad, Associate Professor, Depts. of Epidemiology & Biostatistics and Medicine, UCSF; and author of Ending Medical Reversal and Malignant: How Bad Policy and Bad Evidence Harm People with Cancer
• Rita Redberg, Professor of Medicine, Division of Cardiology, UCSF; and Editor, JAMA Internal Medicine
01:15:43 – Bob Wachter: Closing

See previous Covid-19 Medical Grand Rounds:
• June 4: The Covid-19 Pandemic in the Context of the Healthcare System, Economy, Race, Politics, Ethics, and History
• May 28: Update on Covid-19: Testing, ICU Practices and Outcomes at ZSFG, and the Experience of Elders in the Covid-19 Pandemic
• May 21: Update on Covid-19: Epidemiology, Treatments and Vaccines, Thromboembolic Complications, and the Multisystem Inflammatory Syndrome Affecting Children
• May 14: Covid-19 Update: The ICU Experience in New York, the UCSF Mission and Bolinas Community Studies, and the Uses and Limitations of Antibody Testing

[SEANMCAD]

Thanks so much for doing these ground grounds, between this and Medcram I am the most educated person about COVID within my small social circle

[kedana]

You guys are so awesome. Thank you so much for pulling this together and for all the great balanced scientific information.

[strangeraceteam]

Thank you for a very informative rounds on COVID-19. You provide high quality information and discussions. Your discussions are very thought provoking. Some of those issues I have thought much about.

I hope that electronic medical records eventually improve so that some day in the future, they might actually make work more efficient. That would really lower barriers to mining quality data from the population, both for monitoring effectiveness of treatment strategies but for uncovering new information about disease processes. I think that would take more than 10 years of development to achieve that goal of improving health care worker efficiency. Current EMR development is more driven by billing and oversight, than by the focus on improving quality of care (IMHO).

I think the best approach to address fraud in medical research is cooperation between journal editors/reviewers and the FDA. The FDA has the most capable team for receiving raw data, and performing statistical analysis. If the collection of a large healthcare dataset spanning many different institutions is undertaken, the FDA would be a good entity to record appropriate documents (agreements between the researchers/database administrators and the healthcare institutions), as well as a secure repository of data. The journals still would supply the clinical expertise in reviewing the article, with some assurance that the data is not fraudulent.

Fraudulent studies have as much a bad impact on the health of the population as a poorly studied drug. The review of datasets by the FDA would be inline with the mission statement of the FDA, " Protecting consumers and enhancing public health by maximizing compliance of FDA regulated
products and minimizing risk associated with those products." Published research is a product consumed by the public looking for answers to make decisions. The expansion of the scope of the FDA would only be possible if there is legislation to add that responsibility to the FDA, and fund the manpower necessary. The FDA has had a positive effect on products used in healthcare. Some of the same tools employed by the FDA could be applied to the issues in medical research. Specifically, the FDA could monitor and provide limited validation of datasets used for research. The final analysis of the validity of the article for publication would be completed by the journal reviewers.

[zebrazagadore]

Fascinating. Outstanding presentation and discussion. I consider this to be the most relevant info re the pandemic, particularly in CA.

[jeffsmith]

Great presentation. I wonder how important journals are now or what purpose the journals serve in this climate of questionable quality (poor research, retractions, etc) and other prevalent social media platforms.

[stevenaromero]

Fantastic discussion. I wonder how the conversation would have gone with our U.S. group of doctors and a similar set of doctors from a country with a nationalized healthcare system. Keep up the wonderful work. My household watches this weekly and we are so thankful for you all.

[knox]

While it would be great if the FDA required randomized studies, but I don't see why the journals such as JAMA couldn't require randomized studies as a requirement for publication.

[sandybayes]

Well...there is a problem with our FDA from many perspectives and mainly among the Board and the policy aspect.

[garymarshall]

MyUCLA on line medical records, appointments, communications with medical staff as a Ronald Reagan UCLA Medical Center patient (and UCLA Alumni) I find very efficient and helpful Research documents? Yes ... absolutely.

[Graham_Wideman]

Could someone arrange for Dr Rutherford to be able to visibly point to details on his slides? He seems to believe that he is doing so, but whatever method he's using, perhaps with mouse, doesn't show up on the video. Other than that -- interesting info as usual, thanks.

[AniaMitros]

May I submit a question for next time? Schools are considering using face shields instead of face masks when reopening in the fall. I have not seen evidence of face shield effectiveness, but thinking about it, I would expect a shield to be less effective at containing breathed out particles than a cloth mask. Would you please discuss the effectiveness of face shields vs face masks?

[dancinggirl]

Can you please discuss mass gatherings such as music festivals and their impact on communities? Many events are wanting to come back because of the protests and governors in places like Florida are pressing on to the next phase making it not against state orders to have these events.

[bok.]

Can any of you scholars please help start two small scale studies. I know I am correct, and I have reaffirmed this nearly 100 fold, but need a properly run scientific study in order for it to get published. If you can not, can you point me in the right direction?

[JesterInfester]

I’m sorry that I had to be the one to find the fly speck in the pepper but, Vin did I just hear you say;- “ time savings because Cancer is highly lethal just as Covid is highly lethal ...”? Seriously?

[niftytubeman]

On the issue of speed, masks can slow the transmission and “buy” time for science . The mythical man month lessons apply. Politics is hobbling parallel research . Almost no study program has a shared placebo group. It would be nice to leverage a placebo group against two, four, six even ten interesting medications. The statistics of N+1 allows side by side A vs. B vs. C vs .... all permutation and the double blind placebo group comparison.

[fitzroyarmour]

Hyperbaric 02 in indicated in acute mountain/altitude illness and other indications requiring overcoming tissue hypoxia.
Why isn't it for covid19?

[kevingormley]

Very interesting and I thank you for sharing. I do have one comment that I mean sincerely. I try to be apolitical but the epidemiologist appears to be very political. California has done things right with Covid but “Georgia is lucky”. The reason why California is bad is just because of Los Angles but other states appear to be bad because of their/our lack of mask wearing or social distancing. My only point is to not prejudge the rest of the states using data and your own internal belief system.

[princesstheanaz]

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[seilee]

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[johannesrezeq]

Thank you for a very informative rounds on COVID-19. You provide high quality information and discussions. Your discussions are very thought provoking. Some of those issues I have thought much about.

I hope that electronic medical records eventually improve so that some day in the future, they might actually make work more efficient. That would really lower barriers to mining quality data from the population, both for monitoring effectiveness of treatment strategies but for uncovering new information about disease processes. I think that would take more than 10 years of development to achieve that goal of improving health care worker efficiency. Current EMR development is more driven by billing and oversight, than by the focus on improving quality of care (IMHO).

I think the best approach to address fraud in medical research is cooperation between journal editors/reviewers and the FDA. The FDA has the most capable team for receiving raw data, and performing statistical analysis. If the collection of a large healthcare dataset spanning many different institutions is undertaken, the FDA would be a good entity to record appropriate documents (agreements between the researchers/database administrators and the healthcare institutions), as well as a secure repository of data. The journals still would supply the clinical expertise in reviewing the article, with some assurance that the data is not fraudulent.

Fraudulent studies have as much a bad impact on the health of the population as a poorly studied drug. The review of datasets by the FDA would be inline with the mission statement of the FDA, " Protecting consumers and enhancing public health by maximizing compliance of FDA regulated
products and minimizing risk associated with those products." Published research is a product consumed by the public looking for answers to make decisions. The expansion of the scope of the FDA would only be possible if there is legislation to add that responsibility to the FDA, and fund the manpower necessary. The FDA has had a positive effect on products used in healthcare. Some of the same tools employed by the FDA could be applied to the issues in medical research. Specifically, the FDA could monitor and provide limited validation of datasets used for research. The final analysis of the validity of the article for publication would be completed by the journal reviewers.