Government
COVID-19 vaccines: Open source licensing could keep Big Pharma from making huge profits off taxpayer-funded research
COVID-19 vaccines: Open source licensing could keep Big Pharma from making huge profits off taxpayer-funded research
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An international, multi-billion-dollar race is underway to develop a COVID-19 vaccine, and progress is moving at record speed, but with nationalistic, competitive undertones. If and when an effective vaccine is invented, its production will require an unprecedented effort to vaccinate people across the globe.
However, for the country that invents a safe and effective vaccine, at least in the urgent short term, it will be politically difficult to export vaccines before their own population is immunized. “The only solution,” vaccine development scientist Sandy Douglas told The New York Times, “is to make a hell of a lot of vaccine in a lot of different places.” But how?
Having the public sector fund contracts with vaccine makers is a key component to meeting this future, unprecedented, distribution challenge. But in the United States, there seem to be some disturbing trends.
We are faculty affiliated with two University of Massachusetts campuses. Ford studies environmental microbiology and infectious disease and is former director of the Institute of Global Health at UMass Amherst. Schweik studies how humanity can leverage the internet to collaborate and share innovations toward solving pressing societal problems. COVID-19 is such a problem.
Public sector vaccine R&D contracting
Early-stage vaccine R&D often relies on substantial public sector investment, and this is certainly the case for COVID-19. There are at least 26 vaccines undergoing human trials, nine of which are in Phase 3. If results demonstrate safety and effectiveness, regulators will approve a vaccine license that will allow the organization that invented it to begin manufacturing and distribution.
In the United States, there are many firms with active COVID-19 vaccine R&D contracts financed with large sums of taxpayer money. For example, the company Moderna, which has a vaccine in Phase 3 trials, has received a contract valued at approximately US$955 million. Contracts like these typically fall under the jurisdiction of the Bayh-Dole Act of 1980, a law that grants the inventing firm exclusive license over the product patent. But this law also provides safeguards – “march-in rights” – that allows the federal government to withdraw the exclusivity license if the patented invention is not made available to the public under “reasonable terms.”
Overpricing – essentially asking taxpayers to pay twice for the vaccine, once supporting research and development and then again for purchasing the actual vaccine – would be an example of a situation where march-in rights could apply. In that scenario, the federal government could revoke the exclusive rights from the inventing firm and grant new licenses to other companies to proceed with manufacturing and distribution.
There is, however, an alternative mechanism called “Other Transaction Agreements” (OTA) that allows federal agencies to enter into legally binding R&D contracts which fall outside of the standard types overseen by Bayh-Dole provisions. OTA-based contracts, therefore, are exempt from the “march-in” safety provisions established by Bayh-Dole. Several current vaccine and other COVID-19-related R&D contracts fall under OTAs.
In these cases, U.S. government agencies made an explicit choice to arrange OTAs with these companies. Consequently, pharmaceutical companies receiving funds could potentially charge unreasonably high prices for their COVID-19 treatment or vaccine, and the U.S. Federal Government has no “march-in” recourse to revoke the exclusive license to sell the taxpayer-funded vaccine.
Under OTAs, America’s large financial investments in COVID-19 vaccine development could allow firms control over how their inventions are sold, manufactured and distributed. But to be fair, at least one company – Johnson & Johnson – who received an OTA contract has publicly stated: “We have from the beginning decided we are going to do this not for profit so that the vaccine becomes affordable and available on a global scale as quickly as possible.”
Open sharing of innovations: A case from the industrial revolution
But if society needs to rapidly invent and deliver a vaccine – a global public good – with taxpayer money, why are U.S. federal agencies establishing OTAs that relinquish the government’s ability to share and deploy these inventions and production processes with the world?
We believe that as the U.S. federal government considers future funding to support vaccine manufacturing, policymakers and agency officials need to craft contracts with the suppliers that mandate open sharing of all vaccine production, quality control and distribution.
Schweik has studied open source software that comes with an associated copyright license that promotes free and broad sharing. This licensing dates back to the mid-1980s. The invention of the “General Public License,” sometimes referred to as a viral or reciprocal license, meant that should an improvement be made, the new software version automatically inherits the same license as its parent. We believe that in a time of a global pandemic, a safe and effective COVID-19 vaccine should be licensed with General Public License-like properties.
It turns out, in the early days of the Industrial Revolution, in an effort to rapidly develop standardized small arms parts, the U.S. Army and the Springfield Massachusetts Armory gave contractors open access to designs of new manufacturing equipment with the explicit requirement that if they improved the machines or processes related to them, they had to share these innovations with the national armories and their rival contractors. If these organizations did not comply, they would likely be denied future contractual opportunities. In essence, the armory established a contracting policy similar to General Public License invented roughly 150 years later, which then led to rapid innovation.
A pandemic requires open source sharing
Fortunately, some pharmaceutical companies, national governments, nonprofits like the Bill & Melinda Gates Foundation and international organizations like the Coalition for Epidemic Preparedness Initiatives – which supports vaccine development – are putting policies in place that embrace openness and sharing rather than intellectual property protection.
Coalition for Epidemic Preparedness Initiatives officials have stated that all of their funding agreements require that “appropriate vaccines are first available to populations when and where they are needed to end an outbreak or curtail an epidemic, regardless of ability to pay.” That’s an important start.
However, when there is a safe, effective COVID-19 vaccine, the U.S. and other national governments need to create contractual agreements with firms that provide fair and reasonable funding to cover their costs or even some reasonable profit margin while still mandating the open sharing of the processes for vaccine production, quality assurance and rapid global distribution.
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Of course, rapid global distribution is only the initial goal. To be sustainable, a critical mass of developing country vaccine manufacturers will be necessary, together with a support system for these manufacturers that provides regulatory guidance and access to new formulations.
The longer-term goal must be to build sustainable vaccine manufacturing capacity within low- and middle-income countries. This requires a support system leveraged through the WHO and associated organizations such as Gavi to provide regulatory guidance and access to new formulations through this open source process.
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.
Government
Low Iron Levels In Blood Could Trigger Long COVID: Study
Low Iron Levels In Blood Could Trigger Long COVID: Study
Authored by Amie Dahnke via The Epoch Times (emphasis ours),
People with inadequate…
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Authored by Amie Dahnke via The Epoch Times (emphasis ours),
People with inadequate iron levels in their blood due to a COVID-19 infection could be at greater risk of long COVID.
A new study indicates that problems with iron levels in the bloodstream likely trigger chronic inflammation and other conditions associated with the post-COVID phenomenon. The findings, published on March 1 in Nature Immunology, could offer new ways to treat or prevent the condition.
Long COVID Patients Have Low Iron Levels
Researchers at the University of Cambridge pinpointed low iron as a potential link to long-COVID symptoms thanks to a study they initiated shortly after the start of the pandemic. They recruited people who tested positive for the virus to provide blood samples for analysis over a year, which allowed the researchers to look for post-infection changes in the blood. The researchers looked at 214 samples and found that 45 percent of patients reported symptoms of long COVID that lasted between three and 10 months.
In analyzing the blood samples, the research team noticed that people experiencing long COVID had low iron levels, contributing to anemia and low red blood cell production, just two weeks after they were diagnosed with COVID-19. This was true for patients regardless of age, sex, or the initial severity of their infection.
According to one of the study co-authors, the removal of iron from the bloodstream is a natural process and defense mechanism of the body.
But it can jeopardize a person’s recovery.
“When the body has an infection, it responds by removing iron from the bloodstream. This protects us from potentially lethal bacteria that capture the iron in the bloodstream and grow rapidly. It’s an evolutionary response that redistributes iron in the body, and the blood plasma becomes an iron desert,” University of Oxford professor Hal Drakesmith said in a press release. “However, if this goes on for a long time, there is less iron for red blood cells, so oxygen is transported less efficiently affecting metabolism and energy production, and for white blood cells, which need iron to work properly. The protective mechanism ends up becoming a problem.”
The research team believes that consistently low iron levels could explain why individuals with long COVID continue to experience fatigue and difficulty exercising. As such, the researchers suggested iron supplementation to help regulate and prevent the often debilitating symptoms associated with long COVID.
“It isn’t necessarily the case that individuals don’t have enough iron in their body, it’s just that it’s trapped in the wrong place,” Aimee Hanson, a postdoctoral researcher at the University of Cambridge who worked on the study, said in the press release. “What we need is a way to remobilize the iron and pull it back into the bloodstream, where it becomes more useful to the red blood cells.”
The research team pointed out that iron supplementation isn’t always straightforward. Achieving the right level of iron varies from person to person. Too much iron can cause stomach issues, ranging from constipation, nausea, and abdominal pain to gastritis and gastric lesions.
1 in 5 Still Affected by Long COVID
COVID-19 has affected nearly 40 percent of Americans, with one in five of those still suffering from symptoms of long COVID, according to the U.S. Centers for Disease Control and Prevention (CDC). Long COVID is marked by health issues that continue at least four weeks after an individual was initially diagnosed with COVID-19. Symptoms can last for days, weeks, months, or years and may include fatigue, cough or chest pain, headache, brain fog, depression or anxiety, digestive issues, and joint or muscle pain.
Government
Walmart joins Costco in sharing key pricing news
The massive retailers have both shared information that some retailers keep very close to the vest.
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As we head toward a presidential election, the presumed candidates for both parties will look for issues that rally undecided voters.
The economy will be a key issue, with Democrats pointing to job creation and lowering prices while Republicans will cite the layoffs at Big Tech companies, high housing prices, and of course, sticky inflation.
The covid pandemic created a perfect storm for inflation and higher prices. It became harder to get many items because people getting sick slowed down, or even stopped, production at some factories.
Related: Popular mall retailer shuts down abruptly after bankruptcy filing
It was also a period where demand increased while shipping, trucking and delivery systems were all strained or thrown out of whack. The combination led to product shortages and higher prices.
You might have gone to the grocery store and not been able to buy your favorite paper towel brand or find toilet paper at all. That happened partly because of the supply chain and partly due to increased demand, but at the end of the day, it led to higher prices, which some consumers blamed on President Joe Biden's administration.
Biden, of course, was blamed for the price increases, but as inflation has dropped and grocery prices have fallen, few companies have been up front about it. That's probably not a political choice in most cases. Instead, some companies have chosen to lower prices more slowly than they raised them.
However, two major retailers, Walmart (WMT) and Costco, have been very honest about inflation. Walmart Chief Executive Doug McMillon's most recent comments validate what Biden's administration has been saying about the state of the economy. And they contrast with the economic picture being painted by Republicans who support their presumptive nominee, Donald Trump.
Image source: Joe Raedle/Getty Images
Walmart sees lower prices
McMillon does not talk about lower prices to make a political statement. He's communicating with customers and potential customers through the analysts who cover the company's quarterly-earnings calls.
During Walmart's fiscal-fourth-quarter-earnings call, McMillon was clear that prices are going down.
"I'm excited about the omnichannel net promoter score trends the team is driving. Across countries, we continue to see a customer that's resilient but looking for value. As always, we're working hard to deliver that for them, including through our rollbacks on food pricing in Walmart U.S. Those were up significantly in Q4 versus last year, following a big increase in Q3," he said.
He was specific about where the chain has seen prices go down.
"Our general merchandise prices are lower than a year ago and even two years ago in some categories, which means our customers are finding value in areas like apparel and hard lines," he said. "In food, prices are lower than a year ago in places like eggs, apples, and deli snacks, but higher in other places like asparagus and blackberries."
McMillon said that in other areas prices were still up but have been falling.
"Dry grocery and consumables categories like paper goods and cleaning supplies are up mid-single digits versus last year and high teens versus two years ago. Private-brand penetration is up in many of the countries where we operate, including the United States," he said.
Costco sees almost no inflation impact
McMillon avoided the word inflation in his comments. Costco (COST) Chief Financial Officer Richard Galanti, who steps down on March 15, has been very transparent on the topic.
The CFO commented on inflation during his company's fiscal-first-quarter-earnings call.
"Most recently, in the last fourth-quarter discussion, we had estimated that year-over-year inflation was in the 1% to 2% range. Our estimate for the quarter just ended, that inflation was in the 0% to 1% range," he said.
Galanti made clear that inflation (and even deflation) varied by category.
"A bigger deflation in some big and bulky items like furniture sets due to lower freight costs year over year, as well as on things like domestics, bulky lower-priced items, again, where the freight cost is significant. Some deflationary items were as much as 20% to 30% and, again, mostly freight-related," he added.
bankruptcy pandemic trumpGovernment
Walmart has really good news for shoppers (and Joe Biden)
The giant retailer joins Costco in making a statement that has political overtones, even if that’s not the intent.
Share this:
As we head toward a presidential election, the presumed candidates for both parties will look for issues that rally undecided voters.
The economy will be a key issue, with Democrats pointing to job creation and lowering prices while Republicans will cite the layoffs at Big Tech companies, high housing prices, and of course, sticky inflation.
The covid pandemic created a perfect storm for inflation and higher prices. It became harder to get many items because people getting sick slowed down, or even stopped, production at some factories.
Related: Popular mall retailer shuts down abruptly after bankruptcy filing
It was also a period where demand increased while shipping, trucking and delivery systems were all strained or thrown out of whack. The combination led to product shortages and higher prices.
You might have gone to the grocery store and not been able to buy your favorite paper towel brand or find toilet paper at all. That happened partly because of the supply chain and partly due to increased demand, but at the end of the day, it led to higher prices, which some consumers blamed on President Joe Biden's administration.
Biden, of course, was blamed for the price increases, but as inflation has dropped and grocery prices have fallen, few companies have been up front about it. That's probably not a political choice in most cases. Instead, some companies have chosen to lower prices more slowly than they raised them.
However, two major retailers, Walmart (WMT) and Costco, have been very honest about inflation. Walmart Chief Executive Doug McMillon's most recent comments validate what Biden's administration has been saying about the state of the economy. And they contrast with the economic picture being painted by Republicans who support their presumptive nominee, Donald Trump.
Image source: Joe Raedle/Getty Images
Walmart sees lower prices
McMillon does not talk about lower prices to make a political statement. He's communicating with customers and potential customers through the analysts who cover the company's quarterly-earnings calls.
During Walmart's fiscal-fourth-quarter-earnings call, McMillon was clear that prices are going down.
"I'm excited about the omnichannel net promoter score trends the team is driving. Across countries, we continue to see a customer that's resilient but looking for value. As always, we're working hard to deliver that for them, including through our rollbacks on food pricing in Walmart U.S. Those were up significantly in Q4 versus last year, following a big increase in Q3," he said.
He was specific about where the chain has seen prices go down.
"Our general merchandise prices are lower than a year ago and even two years ago in some categories, which means our customers are finding value in areas like apparel and hard lines," he said. "In food, prices are lower than a year ago in places like eggs, apples, and deli snacks, but higher in other places like asparagus and blackberries."
McMillon said that in other areas prices were still up but have been falling.
"Dry grocery and consumables categories like paper goods and cleaning supplies are up mid-single digits versus last year and high teens versus two years ago. Private-brand penetration is up in many of the countries where we operate, including the United States," he said.
Costco sees almost no inflation impact
McMillon avoided the word inflation in his comments. Costco (COST) Chief Financial Officer Richard Galanti, who steps down on March 15, has been very transparent on the topic.
The CFO commented on inflation during his company's fiscal-first-quarter-earnings call.
"Most recently, in the last fourth-quarter discussion, we had estimated that year-over-year inflation was in the 1% to 2% range. Our estimate for the quarter just ended, that inflation was in the 0% to 1% range," he said.
Galanti made clear that inflation (and even deflation) varied by category.
"A bigger deflation in some big and bulky items like furniture sets due to lower freight costs year over year, as well as on things like domestics, bulky lower-priced items, again, where the freight cost is significant. Some deflationary items were as much as 20% to 30% and, again, mostly freight-related," he added.
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Students lose out as cities and states give billions in property tax breaks to businesses − draining school budgets and especially hurting the poorest students
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Low Iron Levels In Blood Could Trigger Long COVID: Study
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