Cartoon – Downside of Risk Management
Cartoon – While You were Out
Cartoon – Assigning Blame vs Creating Plausible Excuses
Cartoon – Leadership Focus
Cartoon – Change Management
Beijing cuts flights, shuts schools as new coronavirus cases raise alarm
While Beijing’s case numbers are low by global standards, they are vexing Chinese authorities who had touted their success in quickly stamping out the coronavirus and had taken pains to ensure it would not infect the seat of the ruling Communist Party. Government officials announced “wartime” measures on Saturday after dozens of cases were discovered at the Xinfadi wholesale market in southwest Beijing, which carried worrying echoes of the original outbreak in Wuhan late last year.
In the days since, Beijing has steadily reintroduced stricter measures, potentially foreshadowing the difficulty that many governments could face in warding off future waves of covid-19.
After classes resumed just a month ago, Beijing’s schools were again shut on Wednesday, as were some gyms, swimming pools and public attractions. The city raised its emergency response to the second-highest level, and entry and exit checkpoints and temperature checks returned to neighborhoods in the city center. The scenes were reminiscent of those during the outbreak’s peak in February and March, albeit with less-strict lockdown measures.
The risk of people in Beijing traveling in and out of the city and spreading infections countrywide is “severe,” acknowledged Chen Bei, Beijing’s deputy party chief. “We need to take decisive action . . . resolutely control this gathering epidemic and resolutely curb its spread inside and outside the city,” Chen said.
Officials said Beijing has tested 3.56 million people since June 13, underscoring the extent of their concern.
Adding to a sense of frustration with the virus’s reemergence, Chinese experts said it may have been lurking undetected for weeks.
“The Beijing outbreak very likely didn’t start in June, or May, but a month before that,” Gao Fu, head of the Chinese Center for Disease Control and Prevention, told reporters in Shanghai. “There can only be so many cases around us now if there were already many people with no symptoms or light symptoms back then. This is our current speculation, but we need to verify it.”
Chinese researchers say they are examining how the coronavirus made a sudden comeback. Fears that shipped livestock and produce could carry the virus — with potentially worrisome implications for international trade — began circulating this week after it was found at the Xinfadi market on cutting boards used for salmon, which is imported from Europe. The genetic material of viruses found at the market and in patients in Beijing also matched sequences typically found in patients in Europe.
Although the theory was fanned this week by nationalist media outlets including the party-run Global Times — which seized the opportunity to question whether the entire pandemic originated last year in Europe instead of China — Chinese and international experts, including the U.S. Food and Drug Administration, say there is relatively scant evidence that the virus is transmitted on food and packaging.
Wu Zunyou, the Chinese CDC’s top epidemiologist, said Tuesday that the virus was also found throughout the hall of the Xinfadi market, suggesting that the salmon was not necessarily the source. The strain of the virus found in Xinfadi is also prevalent in the United States, Wu added.
Michael Ryan, executive director of the World Health Organization’s Health Emergencies Program, also played down concerns about shipped food as a viral vector, saying the matter requires more study. “I’d be reticent to be in the position where all packaging and other things would need to be systematically tested,” Ryan said. “I don’t think it’s the primary hypothesis, but it needs to be explored.”
Meanwhile, supermarkets and restaurants in Beijing are not taking chances and have stopped selling salmon. The Beijing government said Wednesday it would carry out nucleic testing on all close contacts of people who visited the Xinfadi market, as well as workers in the city’s restaurants, which could number hundreds of thousands of people.
Cases in Beijing are expected to keep rising in the coming days because Xinfadi, which spans an area the size of 250 football fields, is such a large and central part of Beijing’s food distribution network, city officials warned.
As the capital fell again into quasi-lockdown this week, other Chinese cities, including Shanghai, began issuing quarantine requirements and restrictions for travelers from Beijing — a sudden reversal for residents who in normal times enjoy a privileged status.
Officials and state media have called for understanding and cooperation from Beijing residents while rallying citizens nationwide behind the city.
“Go Beijing! Go Zhajiang noodles!” said one popular meme on social media, referring to a classic Beijing dish.
Coronavirus drugmakers’ latest tactics: Science by press release
https://www.politico.com/news/2020/06/05/drugmakers-media-coronavirus-303895
Pharmaceutical companies are using the media to tout treatments that are still under review.
Vaccine maker Moderna attracted glowing headlines and bullish investors when it revealed that eight participants in a preliminary clinical trial of its coronavirus vaccine had developed antibodies to the virus. The company’s share price jumped nearly 20 percent that day as it released a massive stock offering.
But the full results of the 45-person safety study haven’t been published, even though Moderna began a second, larger trial in late May aimed at determining whether the vaccine works. Several vaccine researchers say the scant public information on the earlier safety study is hard to evaluate because it addresses less than 20 percent of participants.
Call it science by press release — a tactic that pharmaceutical companies are increasingly relying upon to set their experimental coronavirus drugs and vaccines apart in a crowded field, shape public opinion and court regulators. Public health experts say the approach could increase political pressure on federal health officials to green-light drugs and vaccines before it is clear they are safe or effective, with potentially dangerous consequences.
“There’s a long history of pharmaceutical manufacturers putting out self-serving press releases related to clinical trial data that they’re developing that present an overly rosy picture of the data, usually with a boilerplate disclaimer at the end, which is fairly useless,” said Aaron Kesselheim, a professor of medicine at Harvard Medical School who studies drug regulation and pricing.
There are already signs of hype and political pressure influencing the U.S.’ coronavirus response. The Food and Drug Administration authorized emergency use of the malaria drug hydroxychloroquine in March without any proof that it was safe or effective for coronavirus patients — but with the backing of President Donald Trump, who had begun touting the treatment during daily White House briefings.
Subsequent studies have found that hydroxychloroquine doesn’t help those with Covid-19 and can cause potentially fatal side effects. And a top government scientist, Rick Bright, filed a whistleblower complaint in May alleging that he was ousted from his job leading the Biomedical Advanced Research Authority after he resisted political pressure to greenlight widespread use of the drug.
“The FDA has remained an unwavering, science-based voice helping to guide the all-of-government response,” agency Commissioner Stephen Hahn said in a statement. “I have never felt any pressure to make decisions, other than the urgency of the situation around COVID-19.”
But observers aren’t so sure. “From the outside looking in, there seems to be more political pressure than ever,” said Marc Scheineson, a former associate commissioner at the FDA and head of the FDA group at Alston & Bird. “The example in the White House is trickling down and there is a lot of pressure on the FDA … to color information on the optimistic side for political purposes and that is a hugely disturbing trend.”
A spokesperson for Moderna, which has received nearly a half billion dollars from the U.S. government and praise from Trump, said the company previewed its vaccine trial results by press release because it was concerned that the data might leak. The National Institutes of Health’s top infectious disease expert, Anthony Fauci, had hinted at the results in an interview with National Geographic, and data from a trial of the experimental drug remdesivir had leaked in April.
“You had this data moving widely around NIH and the remdesivir leak was also in our minds,” the Moderna spokesperson said.
But Peter Bach, director of Memorial Sloan-Kettering’s Center for Health Policy and Outcomes, said Moderna’s effort to preview its findings in the press “could be construed as an effort to make sure they are part of the conversation — and it worked on that front.”
Other groups have also previewed their hotly anticipated vaccine studies in the press. In late April, The New York Times revealed that six monkeys given a vaccine developed by researchers at the U.K.’s University of Oxford had stayed healthy for 28 days despite sustained exposure to the coronavirus. The article quoted Vincent Munster, a researcher at the NIH’s Rocky Mountain Laboratory, which conducted the monkey study at the British scientists’ behest.
The Oxford researchers, who signed a deal with AstraZeneca two days later to develop the experimental vaccine, did not publish a formal scientific analysis of the monkey data until mid-May. The study revealed that the noses of vaccinated monkeys and unvaccinated monkeys contained similar levels of coronavirus particles, suggesting that the vaccinated animals could still spread the disease — and the vaccine might not be as effective as the earlier data had hinted.
AstraZeneca has since inked a $1.2 billion deal with the U.S. government to provide 300 million vaccine doses, and a £65.5 million ($80 million) agreement with the U.K. government to supply 30 million doses.
Liz Derow, a spokesperson for Oxford’s Jenner Institute, where the vaccine researchers are based, said they did not give the monkey data to The New York Times. The NIH’s National Institute of Allergy and Infectious Disease, which operates the Rocky Mountain Laboratory, said it did not provide the data to the newspaper — but one of its researchers, Vincent Munster, spoke to a Times reporter about the monkey findings at the request of the Jenner Institute.
“I was really disturbed by not just Moderna, but the Oxford group as well, presenting a press release without data, without a scientific review, without knowing what the press release was based on,” said Barry Bloom, an immunologist at the Harvard School of Public Health. “And very positively enough to raise the stock price so two days later officials within the company sold their stock and made a whole lot of money, whether or not the vaccine works.”
Four of the pharmaceutical firm’s top executives together saw gains of $29 million from prescheduled sales of shares in the company in the two days following the vaccine announcement. The company has not yet responded to a request for comment on the stock sales.
Neither the Oxford nor Moderna vaccines are available to the public. But some drugs whose safety and efficacy are now being studied have already been repurposed or authorized for emergency use during the pandemic. The rush to release snippets of information on drug trials to the press ahead of full results has left some doctors wondering how to best treat their patients.
After leaked data from a trial of Gilead’s experimental antiviral remdesivir suggested the drug might be the first shown to help coronavirus patients, the company put out a press release in late April teasing results from a larger, government-run study. Hours later, Fauci revealed some findings of the study during an Oval Office press spray.
But the full analysis of the NIAID trial results was not published until three weeks later. Until that point, frontline physicians had no way to know that patients on ventilators did not benefit from remdesivir treatment — meaning that doctors may have inadvertently wasted some of the United States’ limited stock of the drug.
This lack of understanding on how to use remdesivir was evident in a recent survey more than 250 hospitals by the American Society of Health-System Pharmacists, which found that just 15 percent planned to use their remdesivir doses as described in the FDA’s emergency authorization for the drug.
Andre Kalil, an infectious disease doctor at the University of Nebraska Medical Center who led the NIAID trial, told POLITICO that physicians could have patterned their use of remdesivir on the dosages given during the trial.
Others say doctors using experimental treatments should have as much information as possible.
“If we want doctors to make rational medical decisions based on data, then before an authorized product reaches patients, the data should be available to review in some way, not just a press release,” said Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing.
Kesselheim, too, said that clinical trial data should be made public alongside any emergency authorizations to give physicians “the maximum amount of help they need in figuring out how to prescribe the drug.”
Gilead did not respond to a request for comment. But NIAID said that the urgency of the coronavirus prompted Fauci to share initial results before a full analysis was ready for publication.
Ivan Oransky, a professor of medical journalism at New York University and co-founder of the blog Retraction Watch, which monitors errors and misconduct in scientific research, told POLITICO he fears that the temptation to conduct science by press release will get “worse before it gets better.”
The world is growing more desperate for drugs and vaccines that could bring the coronavirus to heel. And many members of the public and politicians are treating every scrap of scientific information about the pandemic equally, he said — whether data comes from a peer-reviewed study or a company press release.
“There have been mechanisms to review science critically that, given the speed of Covid, have gone out the window,” said Bloom.
And interpreting results of clinical trial data can be difficult under the best of circumstances — especially when that data concerns a virus that was unknown to science until December of last year. When to end a trial and which conclusions to highlight are in many cases a matter of discretion, said Scheineson.
“It’s an art, not a science, in that respect,” he said. “I, for one, will not be the first in line to the new Moderna vaccine.”
Industry Voices—Healthcare has a plus-size problem from consolidation. Here are 9 ways to respond
For two decades, healthcare consolidation has been a strong industry trend. But in the COVID-19 era, big healthcare is proving to be a big problem.
Once the community spread of COVID-19 became apparent, large systems turned off the spigot of specialty and nonessential services almost immediately. Now, as these organizations try to entice patients back into services, they face consumers who have good reason to fear the large, populated spaces these systems are built on.
As patients return for care and treatments, large hospitals and health providers need targeted approaches to overcome risk and obstacles. Here are nine strategies to consider for restarting patients:
1. Identify patients and instances with care disruption and high risks associated with care deferral. Knowing which patients are at high risk due to missed appointments plus other risk and time-based analytics will be useful in targeting efforts to bring patients back. Use various technologies to identify prior scheduled procedures and diagnostics.
2. Create a clinical flow for patients in each treatment or appointment category so communication to patients is clear as they are recruited back into the system. The clinical flows should determine which patients will receive telehealth services and who will need physical exams, along with how imaging or laboratory services will be handled to safely address patient time and access to services.
3. Use population health technology to target patients by risk level for services and deferral reasons. Patients who were infected with COVID-19 should be indicated and targeted for services, since this calls for additional surveillance of new risk factors associated with the disease.
4. Contact patients for pre-appointment discussions prior to actual telehealth or personal visits and services. Identify data to collect from patients on symptoms, social determinants and concerns about healthcare or COVID-19 infection so patients can vet their concerns and upcoming discussions with physicians can be more informative.
5. Reimagine the role and functions of some specialists. Because specialty practices are often located in close proximity to many diagnostic services, primary care physicians, who tend to be off campus, can provide initial services in a low-density setting and leave the procedures to specialists.
6. Consider aligning with smaller or more localized services for diagnostics, or provide wearable devices that capture needed clinical data.
7. If feasible, consider whether physical access to some care locations should be redetermined in the short or midterm for patient ease of access.
8. For physical visits or treatments, adjust scheduling to accommodate patient and staff density in clinical or waiting areas.
9. Involve specialists in care and space redesign as well as designing risk criteria. Every specialty will have unique issues that should be accommodated in the design of restarting services.
Planning to improve and strengthen connections to patients in larger healthcare operations will go far toward helping them gain confidence to return during this phase of the pandemic. Now more than ever, we can’t afford a systemwide hit or miss.
Gladwell: COVID-19 should push healthcare to consider its ‘weak links’
The coronavirus pandemic has shown the healthcare industry that it needs to decide whether it’s playing basketball or soccer, journalist and author Malcolm Gladwell said.
Gladwell, the opening keynote speaker at America’s Health Insurance Plans’ annual Institute & Expo, said the two sports exemplify the differences in thinking when one tackles problems using a “strong link” approach versus a “weak link” approach.
In basketball, he said, the team is as strong as its strongest, most high-profile players. In soccer, by contrast, the team is only as strong as its weakest players.
For healthcare organizations, that means making investments in the “weakest links”—such as harried clinicians who may need more training and low-income communities that cannot afford or access coverage—rather than the stronger links, like building out teaching hospitals and physician specializations.
“In healthcare, this is a chance for us to turn the ship around and say we can benefit far more from making health insurance more plentiful and more affordable,” Gladwell said.
Gladwell emphasized that healthcare is far from the only industry to largely follow a “strong link” approach to improvement. In higher education, for example, much of the investment and funding goes to Ivy League institutions and other wealthy, top-performing universities.
Meanwhile, the education system could see significant benefits if it invested in the “weak links” like community colleges and bringing down tuition, Gladwell said.
It’s a similar story in national security—and that “strong link” thinking led to two of the largest security breaches in American history, Gladwell said. Both Edward Snowden and Chelsea Manning were relatively low-ranking people within the security apparatus, but they were able to access critical files and release them.
“I would argue that ‘strong link’ paradigm has dominated every part of American society,” Gladwell said. “We have really put our chips down on the ‘strong link’ paradigm.”
How could a “weak link” approach have impacted the response to the COVID-19 pandemic? Gladwell argues that, for instance, widespread testing is hampered by a lack of supplies like nasal swabs. Investment in the supply chain could have mitigated that challenge, he said.
The virus also disproportionately impacts people with certain conditions, notably diabetes. A broader focus on preventing and treating obesity could have had a large impact on how the pandemic played out, he said.
“With this particular pandemic, I think we’re having a wake-up call,” Gladwell said.
Highmark, HealthNow New York enter affiliation agreement
Highmark is expanding its reach into New York through an affiliation with HealthNow New York.
The acquisition is pending regulatory approval, the two Blues insurers announced Tuesday. Should it be finalized, HealthNow’s plans will continue to operate locally as Highmark BlueCross BlueShield of Western New York and Highmark BlueShield of Northeastern New York.
HealthNow will bring nearly 1 million additional members into the Highmark fold and boasted $2.8 billion in revenue for 2019. It will join the fourth largest Blues organization in the country, building on Highmark’s 5.6 million members and $18 billion in operating revenue for 2019.
David Holmberg, Highmark’s CEO, said on a call with reporters that Highmark has been pursuing a “focused growth strategy of working with like-minded partners” to improve care quality and affordability.
“We believe together Highmark and HealthNow can be transformational as we prepare healthcare for the next generation of people in all of our regions,” Holmberg said.
Highmark entered intro similar affiliations to expand into Delaware and West Virginia.
HealthNow will maintain its Buffalo headquarters as well as offices in the Albany area and will maintain a significant amount of local autonomy, executives said on the call. The boards of both insurers have unanimously signed off on the deal.
Dave Anderson, CEO of HealthNow, will remain at the helm once the two insurers have integrated. Anderson told reporters that uniting with Highmark allows it to maintain its community-based presence and approach while tapping into the scale of the larger health plan.
He said the affiliation has been in the works for more than two and a half years, but the COVID-19 pandemic highlighted just how critical the additional scale would be to filling some of the gaps exposed as the virus spread.
So while COVID-19 wasn’t on either company’s radar as talks began, the pandemic did play a key role in underscoring the value of uniting, Anderson said.
“COVID has essentially emphasized the strategy that we put in place,” he said.
The insurers did not offer an estimated timeline for the affiliation to be completed.
