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Key Analyst Overestimates Remdesivir Revenue in Billions ignoring Limited Effectiveness from Trials

Estimating a US price tag of $5K per course, remdesivir is set to make billions for Gilead, says key analyst

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This article was originally published in EndPoints.

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.
Geoffrey Porges
Gilead has been reticent about its pricing plans, with company chief Dan O’Day emphasizing the need for the company to be responsible. “I don’t think there is a precedent for this,” he said in response to the question posed by SVB Leerink analyst Geoffrey Porges in a post-earnings conference call last month. “There is no rule book out there, other than that we need to be very thoughtful about how we can make sure we provide access to our medicine to patients around the globe and do that in a sustainable way for the company.” But on Wednesday, Porges said he expected the drug to carry a list price of $5000 per course in the United States, above the cost-effective estimate of $4,500 generated by ICER, an increasingly influential watchdog that typically favors a conservative approach to pricing based on an intervention’s benefit beyond the standard-of-care. Although Remdesivir is the only therapy so far to show a statistically significant impact in helping hospitalized Covid-19 patients with moderate-to-severe disease recover faster (by four days) in a randomized, placebo-controlled study — the gold-standard for benefit-risk calculations — it is by no means a silver bullet. The drug, which thwarts an enzyme the virus relies on to replicate, did not reduce the rate of mortality by a statistically significant extent in the trial. ICER broke its usual practices in early May to conduct its own analysis based on ‘raw and immature data’ to come up with two different ways to reasonably price for the drug. The first, the ‘cost recovery’ model in which the manufacturer prices the therapy on the basis of the minimum costs of production, chalked up a price of $10 for a 10-day course. (Although data from a Gilead trial suggest a 5-day regimen of the drug is as effective as the 10-day course). But under the traditional cost-effectiveness model, which looks at incremental health benefits and costs within the health system, the company would be justified to sell the same regimen for $4,500, ICER suggested in a draft report.
Michael Carrie Rutgers University

Michael Carrier, a Rutgers University law school professor who specializes in intellectual property, in a previous interview with Endpoints News noted that there isn’t any simple formula to calculate the ideal price of a therapy. “Just psychologically, a cost or price below $1,000 seems to be more affordable. I don’t think it’s going to be $10. I don’t think it’ll be close to $4500.”

“Wall Street expecting $GILD to extract maximum revenue exceeding treatment value.  No one should be surprised by this,” said Peter Bach, the director of Memorial Sloan Kettering’s Center for health policy and outcomes, in response to Porges’ estimate of $5,000-per-course on Twitter. Gilead rose to prominence by vaulting HIV to the ranks of a chronic disease and as the purveyor of impossibly high-priced, but fantastically effective, hepatitis C drugs. Originally priced at $1000 per hep C pill, the US drugmaker drew the wrath of lawmakers and policymakers at home and abroad, and as a result of intense scrutiny and emerging competition, prices were revised downwards. Porges, on Wednesday, estimated the drug will be priced at $4000 per course in Europe and $2000 for the same regimen in other markets. Overall, the forecast global remdesivir sales is $1.9 billion by the end of this year, jumping to $6.7 billion in 2021 (bolstered by government stockpiling) and then in a range of $5.8 to $6.9 billion in later years.
Peter Bach
“This forecast has more uncertainty than any that we have published in the last 15 years, but it reflects our view that remdesivir works, it saves medical and societal costs by shortening disease duration and reducing severity, and we believe that Gilead will be permitted to capture reduced but still real profitability from the product,” he wrote. “We also believe that SARS-nCoV2 (the virus behind Covid-19) is not going away, or being eliminated by vaccination (we do forecast gradual adoption of vaccination, but in our view that is unlikely to stop government stockpiling of remdesivir).” Porges’ forecast is generous, but the data on the drug are less than stellar. Only days ago, Gilead unveiled data from an open-label late-stage study that generated more questions than answers on the magnitude of remdesivir’s benefit in the treatment of Covid-19. In this trial, patients classified as having moderate disease were 65% more likely to show “clinical improvement” on a five-day regimen compared to those given standard-of-care — but not those on the 10-day course. The dichotomy perplexed Baird analyst Brian Skorney. The data “continue to indicate a very marginal clinical benefit, while reinforcing that a benefit is likely more than random noise,” he wrote in a note. “We continue to believe that both the commercial opportunity for Gilead and the macro benefit of remdesivir to society, at large, is very limited.” Gilead, meanwhile, has already donated 200,000 course supply of remdesivir to governments, invested $50 million in developing the drug, and expects to spend another $1 billion as it ramps up further development and manufacturing of remdesivir. The company plans to disclose its pricing plans in the coming weeks and kick off commercial sales in the second half of this year. Stockpiling could begin in late 2021, after drug production has been amped up, Porges said. “We assume that peak profitability (operating margin) for remdesivir is 19% in 2021, and then declines as more and more revenue comes from heavily discounted (80%+) government stockpiling purchases. As a result of the much lower profitability compared to Gilead’s core business, the incremental profit contribution is relatively small (+2% in 2020, +10% in 2021 and then +1-4% in later years).” In the United States, days after topline data on the drug were announced by the NIH, the FDA issued a quick emergency use authorization (a temporary move to allow access to the drug while its maker gathers more data in order to pursue standard approval). In the European Union, the medicines regulator has recommended expanding compassionate use of remdesivir in severe Covid-19 patients, while a rolling review of the drug is ongoing. In the UK, the Gilead has struck a deal with the government to supply the drug for certain Covid-19 patients. Social image: Daniel O’Day, AP Images

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Why it May be Time to Start Stocking up on Weed

There’s an important change coming that may force users to change their behavior.

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There's an important change coming that may force users to change their behavior.

While inflation has already ruined many people's plans for a summer trip cross-country, the impact of rising prices may soon hit some people where it'll really hurt.

Cannabis, and many of its related products, has so far largely escaped the kind of double-digit increases seen in many food products such as chicken to avocados — one analytics firm even reported that the price of marijuana flowers, edibles and vaping products fell by a respective 16.7%, 11.8% and 12.4% between January 2021 and 2022.

But for interconnected reasons having to do with everything from lack of available materials to supply chain disruption, prices for most things have been rising steadily and at a rate unseen in 40 years. 

Even if the main item hasn't increased in price, rising costs for packaging material has left almost no industry unaffected.

Between June 2021 and 2022, the consumer price index rose by 9.1%.

Has Inflation Finally Come For People's Weed?

And, as the latest report from cannabis industry and accounting firm GreenGrowth CPAs shows, inflation may have finally started coming for the cannabis industry.

Amid rising cost of labor and materials necessary to make ready-to-consume cannabis, one in every four retailers that produce it reported that they have either raised or plan to raise prices by more than 10% in the next year.

"The COVID-19 pandemic had a comparatively limited impact on cannabis operators," reads the report. "According to last year’s data set, the top two reported issues, supply chain and difficulty hiring, affected nearly all sectors in 2021. [...] In addition, the most common issue impacting operators today are supply challenges."

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The survey examined over 700 companies in states where either recreational or medical marijuana use is legal. These include both start-ups and large multi-state operators.

While 70% of operators said they would try to absorb rising costs instead of raising prices, 30% plan to raise prices preemptively to prevent losses.

Pointing the Finger 

The study's respondents split over who to blame for rising inflation, with 40% citing Biden administration policies, and 30% citing carryover effects from Trump administration policies.

Other reasons cited by operators include supply chains, conflicts with countries like Russia and China and impact from petroleum companies' way of doing business.

Nationwide numbers rarely tell the whole picture since cannabis use and production are currently illegal at a federal level. But even with rising prices, demand has been strong both during the COVID-19 outbreak and after. Some online delivery services in California reported a 500% rise in sales since the start of quarantine.

"After two years marked by crisis and uncertainty following a global pandemic, financial operators in cannabis find themselves navigating a list of new complications and business obstacles," reads the report. "But it isn't all bad news. Many operators benefited from a surge of demand and used this new windfall to enact ambitious growth plans."

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Sex work is real work: Global COVID-19 recovery needs to include sex workers

Societally, we need to recognize that sex workers have agency and deserve the same respect, dignity and aid as any other person selling their labour.

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Globally, sex workers have been left to fend for themselves during the pandemic with little to no support from the government. (AP Photo/Bikas Das)

During the pandemic, business shifted from in person to work-from-home, which quickly became the new normal. However, it left many workers high and dry, especially those with less “socially acceptable” occupations.

The pandemic has adversely impacted sex workers globally and substantially increased the precariousness of their profession. And public health measures put in place made it almost impossible for sex workers to provide any in-person service.

Although many people depend on sex work for survival, its criminalization and policing stigmatizes sex workers.

Research shows that globally, sex workers have been left behind and in most cases excluded from government economic support initiatives and social policies. There needs to be an intersectional approach to global COVID-19 recovery that considers everyone’s lived realities. We propose policy recommendations that treat sex work as decent work and that centre around the lived experiences and rights of those in the profession.

Sex work and the pandemic

The United Nations Population Fund (UNFPA) recently reported that apart from income-loss, the pandemic has increased pre-existing inequalities for sex workers.

In a survey conducted in Eastern and Southern Africa, the UNFPA found that during the pandemic, 49 per cent of sex workers experienced police violence (including sexual violence) while 36 per cent reported arbitrary arrests. The same survey reported that more than 50 per cent of respondents experienced food and housing crises.

Lockdowns and border closures adversely impacted Thailand’s tourism industry which relies partially on the labour of sex workers.


Read more: Sex workers are criminalized and left without government support during the coronavirus pandemic


In the Asia Pacific, sex workers reported having limited access to contraceptives and lubricants along with reduced access to harm reduction resources. Lockdowns also disrupted STI or HIV testing services, limiting sex workers’ access to necessary healthcare.

In North America, sex workers have been excluded from the government’s recovery response. And many began offering online services to sustain themselves.

A woman stands backlit next to a dimly lit bus that reads 'Thailand' with green lighting.
Sex workers stand in a largely shut-down red light area in Bangkok, Thailand on March 26, 2020. (AP Photo/Gemunu Amarasinghe)

Government vs. community response

Globally, sex workers have been left to fend for themselves during the pandemic with little to no support from the government. But communities themselves have been rallying.

Elene Lam, founder of Butterfly, an Asian migrant sex organization in Canada, talks about the resilience of sex wokers during the pandemic.

She says organizations like the Canadian Alliance for Sex Work Law Reform are working in collaboration with Amnesty International to mobilize income support and resources to help sex workers in Canada.

Organizations in the United Kingdom, Germany, India and Spain have also set up emergency support funds. And some sex worker organizations have developed community-specific resources for providing services both in person and online during the pandemic.

Global recovery needs to include sex workers

The International Labour Organization’s “Decent Work Agenda” emphasizes productive employment and decent working conditions as being the driving force behind poverty reduction.

Sociologist Cecilia Benoit explains that sex work often becomes a “livelihood strategy” in the face of income and employment instability. She says that like other personal service workers, sex workers also should be able to practice without any interference or violence.

In order to have an inclusive COVID-19 recovery for all, governments need to work to extend social guarantees to sex workers — so far they haven’t.

As pandemic restrictions disappear, it is crucial to ensure that everyone involved in sex work is protected under the law and has access to accountability measures.

A woman stands wearing a mask with a safety vest on in front of a collage of scantily clad women and a sign that reads 'nude women non stop'
A volunteer helps out at Zanzibar strip club during a low-barrier vaccination clinic for sex workers in Toronto in June 2021. THE CANADIAN PRESS/Frank Gunn

Recommendations

As feminist researchers, we propose that sex work be brought under the broader agenda of decent work so that the people offering services are protected.

  1. Governments need to have a legal mandate for preventing sexual exploitation.

  2. Law enforcement staff need to be trained in better responding to the needs of sex workers. To intervene in and address situations of abuse or violence is critical to ensure workplace safety and harm reduction.

  3. Awareness and educational campaigns need to focus on destigmatizing sex work.

  4. Policy-makers need to incorporate intersectionality as a working principle in identifying and responding to the different axes of oppression and marginalization impacting LGBTQ+ and racialized sex workers.

  5. Engagement with sex workers and human rights organizations need to happen when designing aid support to ensure that an inclusive pathway for recovery is created.

  6. Globally, there needs to be a steady commitment towards destigmatizing sex workers and their services.

Despite the gradual waning of pandemic restrictions, sex workers continue to face the dual insecurity of social discrimination and loss of income support. Many are still finding it difficult to stay afloat and sustain themselves.

Societally, we need to recognize that sex workers have agency and deserve the same respect, dignity and aid as any other person selling their labour.

The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

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OU researchers award two NSF pandemic prediction and prevention projects

Two groups of researchers at the University of Oklahoma have each received nearly $1 million grants from the National Science Foundation as part of its…

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Two groups of researchers at the University of Oklahoma have each received nearly $1 million grants from the National Science Foundation as part of its Predictive Intelligence for Pandemic Prevention initiative, which focuses on fundamental research and capabilities needed to tackle grand challenges in infectious disease pandemics through prediction and prevention.

Credit: Photo provided by the University of Oklahoma.

Two groups of researchers at the University of Oklahoma have each received nearly $1 million grants from the National Science Foundation as part of its Predictive Intelligence for Pandemic Prevention initiative, which focuses on fundamental research and capabilities needed to tackle grand challenges in infectious disease pandemics through prediction and prevention.

To date, researchers from 20 institutions nationwide were selected to receive an NSF PIPP Award. OU is the only university to receive two grants to the same institution.

“The next pandemic isn’t a question of ‘if,’ but ‘when,’” said OU Vice President for Research and Partnerships Tomás Díaz de la Rubia. “Research at the University of Oklahoma is going to help society be better prepared and responsive to future health challenges.”

Next-Generation Surveillance

David Ebert, Ph.D., professor of computer science and electrical and computer engineering in the Gallogly College of Engineering, is the principal investigator on one of the projects, which explores new ways of sharing, integrating and analyzing data using new and traditional data sources. Ebert is also the director of the Data Institute for Societal Challenges at OU, which applies OU expertise in data science, artificial intelligence, machine learning and data-enabled research to solving societal challenges.

While emerging pathogens can circulate among wild or domestic animals before crossing over to humans, the delayed response to the COVID-19 pandemic has highlighted the need for new early detection methods, more effective data management, and integration and information sharing between officials in both public and animal health.

Ebert’s team, composed of experts in data science, computer engineering, public health, veterinary sciences, microbiology and other areas, will look to examine data from multiple sources, such as veterinarians, agriculture, wastewater, health departments, and outpatient and inpatient clinics, to potentially build algorithms to detect the spread of signals from one source to another. The team will develop a comprehensive animal and public health surveillance, planning and response roadmap that can be tailored to the unique needs of communities.

“Integrating and developing new sources of data with existing data sources combined with new tools for detection, localization and response planning using a One Health approach could enable local and state public health partners to respond more quickly and effectively to reduce illness and death,” Ebert said. “This planning grant will develop proof-of-concept techniques and systems in partnership with local, state and regional public health officials and create a multistate partner network and design for a center to prevent the next pandemic.”

The Centers for Disease Control and Prevention describes One Health as an approach that bridges the interconnections between people, animals, plants and their shared environment to achieve optimal health outcomes.

Co-principal investigators on the project include Michael Wimberly, Ph.D., professor in the College of Atmospheric and Geographic Sciences; Jason Vogel, Ph.D., director of the Oklahoma Water Survey and professor in the Gallogly College of Engineering School of Civil Engineering and Environmental Science; Thirumalai Venkatesan, director of the Center for Quantum Research and Technology in the Dodge Family College of Arts and Sciences; and Aaron Wendelboe, Ph.D., professor in the Hudson College of Public Health at the OU Health Sciences Center.

Predicting and Preventing the Next Avian Influenza Pandemic

Several countries have experienced deadly outbreaks of avian influenza, commonly known as bird flu, that have resulted in the loss of billions of poultry, thousands of wild waterfowl and hundreds of humans. Researchers at the University of Oklahoma are taking a unique approach to predicting and preventing the next avian influenza pandemic.

Xiangming Xiao, Ph.D., professor in the Department of Microbiology and Plant Biology and director of the Center for Earth Observation and Modeling in the Dodge Family College of Arts and Sciences, is leading a project to assemble a multi-institutional team that will explore pathways for establishing an International Center for Avian Influenza Pandemic Prediction and Prevention.

The goal of the project is to incorporate and understand the status and major challenges of data, models and decision support tools for preventing pandemics. Researchers hope to identify future possible research and pathways that will help to strengthen and improve the capability and capacity to predict and prevent avian influenza pandemics.

“This grant is a milestone in our long-term effort for interdisciplinary and convergent research in the areas of One Health (human-animal-environment health) and big data science,” Xiao said. “This is an international project with geographical coverage from North America, Europe and Asia; thus, it will enable OU faculty and students to develop greater ability, capability, capacity and leaderships in prediction and prevention of global avian influenza pandemic.”

Other researchers on Xiao’s project include co-principal investigators A. Townsend Peterson, Ph.D., professor at the University of Kansas; Diann Prosser, Ph.D., research wildlife ecologist for the U.S. Geological Survey; and Richard Webby, Ph.D., director of the World Health Organization Collaborating Centre for Studies on the Ecology of Influenza in Animals and Birds with St. Jude Children’s Research Hospital. Wayne Marcus Getz, professor at the University of California, Berkeley, is also assisting on the project.

The National Science Foundation grant for Ebert’s research is set to end Jan. 31, 2024, while Xiao’s grant will end Dec. 31, 2023.


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