Following pharmaceutical company Eli Lilly’s much-lauded move to cut US prices for its insulin products, US President Joe Biden is calling on other drugmakers to make similar reductions for the vital medication.
According to Euronews, Lilly is directly slashing its insulin prices by about 70%, since many patients cannot access discounts, and is capping consumer costs at US$35 (R635) a month.
Biden is driving a push for cheaper insulin, signing a law that capped insulin at US$35 a month for senior citizens on Medicare, and urged companies to lower prices on their own. “For far too long, American families have been crushed by drug costs many times higher than what people in other countries are charged for the same prescriptions,” Biden said.
“Insulin costs less than US$10 to make, but Americans are sometimes forced to pay over US$300 for it. It’s flat wrong”.
Biden has called for a national cap on insulin prices, but his current Act does not extend to that.
A Lilly press release revealed that the price of Humalog® (insulin lispro injection) 100 units/mL (Lilly’s most commonly prescribed insulin) and Humulin® (insulin human) injection 100 units/mL by would be cut by 70%. This price change would take effect around the end 2023. Lilly also said it would cut the price for the generic Lispro to US$25 a vial starting in May. In South Africa, a Humulin® 10mL vial costs R525.28, or US$28.08, according to Health-e’s medicine price registry.
Lilly CEO David Ricks said his company was bringing the changes as not all patients could benefit through discounts through insurers or pharmacy benefit managers.
“We are driving for change in repricing older insulins, but we know that 7 out of 10 Americans don’t use Lilly insulin. We are calling on policymakers, employers and others to join us in making insulin more affordable,” said Ricks. “For the past century, Lilly has focused on inventing new and improved insulins and other medicines that address the impact of diabetes and improve patient outcomes. Our work to discover new and better treatments is far from over. We won’t stop until all people with diabetes are in control of their disease and can get the insulin they need.”
Since insurers and pharmacies will take a while to implement the price cuts, Lilly will immediately cap monthly out-of-pocket costs at $35 for people who are not covered by Medicare’s prescription drug programme.
By Yanga Nokhepheyi, Marlise Richter, and Fatima Hassan for Spotlight
A frightful piece of information came to light recently. The pharmaceutical giant Pfizer announced its 2022 revenue at $100 billion. This is more than the combined health spending of 108 countries in 2020 according to calculations of The People’s Vaccine Campaign. The Pfizer COVID vaccine, of course, helped the dollars roll in. In fact, some reports suggest that Pfizer charged some countries $130 per dose of vaccine, while it is estimated that it costs less than $2 per dose to make. That equated to a markup of a stupefying 10 000% but we don’t know the full pricing details because the contracts are marked ‘secret’.
Figures like these make one’s eyes water.
In this pandemic, tackling the pharmaceutical sector and the perversities of its pandemic profiteering has been the focus of an international movement of health activists united under the banner of the People Vaccine Campaign. Partly because of severe resistance by governments in the global north and inaction locally, access to timely supplies of affordable and essential COVID vaccines, medicines and diagnostics has not materialised. But the struggle continues not only to tackle these structural barriers to beat COVID and future pandemics but also to help ensure implementation of Universal Health Coverage (UHC) systems. UHC means that everyone would be able to get the quality health services they need and benefit from scientific progress – irrespective of their ability to pay and without having to face financial hardship.
A Herculean task
South Africa, too, has committed to attaining UHC by 2030 as part of a set of promises made on the United Nation’s Sustainable Development Goals. South Africa’s main strategy to attain UHC is to implement a National Health Insurance (NHI) system. Unfortunately, progress has been historically slow, but in the build-up to the 2024 elections, the African National Congress (ANC) Members of Parliament (MPs) are rushing the law reform process despite an acknowledgement even from the health ministry that progress and timelines are hampered by the socio and mainly economic impacts of the pandemic. This includes a fiscus crisis with additional pandemic-related debt, and according to Dr Nicholas Crisp, Deputy Director-General in the health department responsible for NHI, “the NHI could take decades to be implemented at full scale”.
It will require a Herculean task to unify our apartheid-era two-tiered healthcare system, with the right skills, funding base, and transparency in decision-making around health policy and medicine selection. The pandemic has highlighted why all these elements are critical for healthcare for everyone.
We provide a short overview of our research below.
Law reform
Last year, the Portfolio Committee on Health in Parliament deliberated on the ‘NHI Bill’, but there were no significant changes made to it. It needs major revision. Many serious concerns and recommendations from parliamentary submissions by multiple stakeholders have gone unaddressed. The Health Justice Initiative (HJI) has focused on medicine procurement provisions in the Bill and in 2022 raised at least 17 questions that require greater attention before the law is passed. Neglecting to address the public’s submissions is not surprising seeing that ANC MPs serving on the committee were resolute in having the National Assembly adopt the Bill before the ANC Conference in December 2022. However, time ran out before the adoption of the Bill by Parliament, and the Parliamentary process is seemingly going to resume this month.
Stakeholder submissions to Parliament on the Bill (of which there were 64 000 written submissions following Parliament’s call for comment in 2019) and various commentators have warned about the ‘looming disaster’ that the Bill in its current form poses, but they are often divided on the main reasons. A tiny minority resists the principle of unified health systems and Universal Health Care for all (meaning, also for the poor). Many more groups agree that NHI is an ethical necessity but are concerned about South Africa’s disintegrating public health system, energy crisis, high levels of state corruption involving health product procurement, and the in/ability of the Department of Health to actually implement NHI in its current proposed form.
Other groups have rightfully pointed out concerns over conferring too much power on the Minister of Health, inadequate financing models, the feasibility of NHI in SA post-COVID, and the exclusion of specific categories of people from NHI. (For a curated archive of critical submissions, please see here).
Risks to medicine access
Regrettably, the provisions in the Bill on Medicine Selection, Pricing, and Procurement are ambiguous at best, and as the HJI pointed out in 2022, the entire shift of our medicine selection, procurement, and reimbursement system to “NHI reimbursement” has not been adequately thought through, potentially posing a great risk for the future of medicine selection and access in the country for all people. This requires immediate attention at the highest levels of the executive and the legislature too – and likely needs a multi-department and stakeholder technical group to urgently determine the exact trajectory of this planned process.
The World Health Organization has emphasised that UHC programmes will only be successful if there is “affordable access to safe, effective, and quality medicines and health products”. In addition, the COVID pandemic has taught us that timely and fairly priced access to essential diagnostics, therapeutics, and vaccines is key to addressing any public health emergency and improving health outcomes. We cannot safeguard public health without access to medicines – procured fairly, delivered on time, and based on expert and transparent decision-making and approval.
The cost of medicine, as elsewhere in the world where there are national health systems, remains a key concern. The Minister of Health last November in the National Assembly said that the funds for the NHI would be collected through a combination of taxes, including the reallocation of medical scheme credits paid to medical schemes, provincial health budgets to the NHI Funds, and payroll tax.
The financial feasibility of implementing the NHI is still unclear and a huge risk to the fiscus in a post-COVID economy that is dealing with a recession, load shedding, and high unemployment rates.
In late 2022, HJI argued that the Bill does not adequately consider the complexities of medicines access and that our medicines system could be severely jeopardised if poorly drafted sections in the current Bill become law. We said that government should set up a task team to urgently determine the exact trajectory of this planned process.
The Health Department’s recent response to submissions and its own recommendations on amendments to the Bill sadly does not realise the gravity of the threat to the future of medicine selection and access.
17 questions
In HJI’s 2022 analysis of the Bill, we raised 17 key questions that we believe must be addressed by lawmakers in the next version of the Bill and before NHI comes into effect. These include:
What specific measures are envisaged to enable and promote public transparency related to medicine selection, procurement, and contracting processes under the NHI?
How will the price of medicines not included in or covered by the NHI be regulated? And what role will External Reference Pricing (ERP) methodology play in the NHI and beyond?
How will the NHI Fund (e.g., the Office of Health Products Procurement, the NHI Board) negotiate with global pharmaceutical manufacturers and suppliers to procure for government and how will that process be transparent and accountable?
How will the Minister determine that the NHI is ‘fully implemented’, and what will take place in terms of what medical schemes can and cannot offer members during the transition period, and after the (undefined) date?
Has consideration been given to designing a competitive and different single medicine pricing system for SA?
Drawing on our work on medicine access during the HIV and COVID pandemic, we appreciate that there are powerful vested interests located in the multi-trillion-dollar pharmaceutical industry – this is why there is a need for legal safeguards, sound legislation, and independent and transparent institutions to ensure access to affordable medicines for all of us living here.
The pandemic showed that a lack of transparency, autonomy, and information around expert advice can bedevil open government decision-making. Secret procurement contracts for essential vaccines could become the norm even under NHI as they did in COVID, something we are fighting in our courts to open up, later this year.
Figuring out a sound system for a unified medicine access system under NHI is a formidable undertaking that requires a multi-disciplinary task team with experts from various fields, experience, and technical know-how. It is not easy to simply merge two parallel medicine procurement and selection systems. The risk is that the status quo could continue – where the rich and insured access the best medicines at a higher price.
We believe that the principles underpinning NHI for our highly regressive, unequal two-tiered healthcare system are too important for our collective health, well-being, and our Constitutional democracy to have lacklustre legal provisions and worrying gaps on the essential issues of medicine procurement and selection.
As the Bill currently stands, it will strengthen the private healthcare sector’s stranglehold on us and our fiscus. It will leave us at the mercy of advisory committees that bear no duty to be transparent in deciding which medicines you and I will be able to access under NHI.
We can and need to do better.
* Nokhepheyi and Richter are researchers and Hassan the Director of the Health Justice Initiative.
Inaccurately recording the start of anaesthesia care during a procedure is common and results in significant lost billing time for anaesthesia practices and medical centres, suggests a study being presented at the American Society of Anesthesiologists’ ADVANCE 2023, the Anesthesiology Business Event.
The anaesthesia start time (AST) must be documented from a computer logged into the electronic health record (EHR), and typically occurs once the patient is in the operating room (OR). However, the anaesthesiologist meets with the patient prior to their arrival in the OR and begins tasks that are vital to the procedure, such as administering pre-medication and attaching monitors, time which is is not typically recorded. Depending on the patient and procedure, adding two to five minutes to the AST when logging it would account for the preparation and transit time, researchers say.
“These seemingly minor inaccuracies of recorded AST can cost medical centres and anaesthesia practices hundreds of thousands of dollars in lost revenue,” said Nicholas Volpe Jr, MD, MBA, lead author of the study and an anaesthesiology resident physician at Northwestern University McGaw Medical Center, Chicago. “We suspect most anaesthesiologists are unaware that they aren’t recording AST accurately. It’s not a result of negligence, but rather reflects that workflow hasn’t been optimised for accuracy.”
For the study, the researchers analysed 40 312 procedures with anaesthesia over 12 months at a single academic centre. In 68.74% of cases , AST was recorded as starting once the patient was in the OR, without factoring in the preparation time. Using the national average charge for anesthaesia time, the missing time translated to over $600 000 in lost revenue for the year, the researchers determined.*
“Logging AST is one of the many new tasks that anaesthesiologists learn when starting a new role,” said Dr Volpe. “Transitioning from an internship to clinical anaesthesia practice involves learning a significant amount of new information, and understanding the importance of an accurately recorded AST may seem like a relatively minor issue compared to important patient-care information.”
Several approaches could help address inaccurate AST documentation, including educating anaesthesiologists on how to improve their AST recording practices and providing visual reminders such as signs in the OR, Dr Volpe said. Also, an AST capture function could be built into the EHR mobile application so that AST can be noted by anaesthesiologists on the way to the OR, or the EHR could automatically add two minutes to the AST log time, he said. The researchers plan to roll out some of those initiatives in the spring and determine if they are effective.
*The projected savings are theoretical and not linked to billing at the institution where the study was conducted.
In recent times, new drug discoveries by independent large pharmaceutical companies have become increasingly rare, with almost 60% of new drugs discovered through mergers and acquisitions and drug licensing. Fortunately, an emerging trend of spinouts from academia and R&D investments heralds a promising shift in the industry’s interorganisational deal networks to improve research and development in the future. Researchers explore this new trend in Drug Discovery Today.
Launching a new drug in the market is risky, thanks to a low probability of success during the research and development (R&D) phase and the high costs involved. But through an improved understanding of disease biology, decision-making can be more streamlined through the effective use of scientific information.
With this in mind, researchers from Ritsumeikan University, Japan, led by Associate Professor Kota Kodama are uncovering how the trends in interorganisational deals in the pharmaceutical industry are changing to improve R&D productivity and drug discovery. “The network structure of innovation creation in the pharmaceutical industry has changed with the increasing emergence of start-up companies spinning out from academia and research institutions as players in the source of innovation,” explains Dr Kodama.
Their research suggests that the knowledge necessary for breakthrough innovation in drug discovery is more often than not obtained through alliance networks. Over the past decade, large research-based pharmaceutical companies have used research collaborations, innovation incubators, academic centres of excellence, public-private partnerships, mergers and acquisitions (M&As), drug licensing, and corporate venture capital funds as typical methods for external innovation. The researchers now aim to define the changes in the network structure and nature of such alliances that have occurred over the past decade to provide future strategic insights for industry and academic players involved in drug discovery.
Using data from the Cortellis Competitive Intelligence database, the researchers identified nearly 50 000 deals of various kinds related to pharmaceutical R&D across pharmaceutical, digital health software, animal drug, and medical device companies to uncover trends in the creation of new drugs for human use. They also studied the trends of 13 of the largest pharmaceutical companies with annual revenues of more than US$10 billion, who saw an improvement in their CAGR (compound annual growth rate) since 2015. The researchers noticed that the rising CAGR correlated to a significant change in M&A-related deals after 2015, indicating that M&A-related deals drive revenue growth for large pharmaceutical companies.
Furthermore, the number of organisations involved in interorganisational deals has been increasing yearly from 2012 to 2021. Although the number of organisations involved and the number of deals may be increasing, the density of the deal networks is decreasing annually, suggesting that networks are becoming more non-cohesive. The concentration of business relationships between organisations of certain areas in the network changed to dispersion around 2015, and new networks connecting different groups started to form after 2017. These trends are an important illustration of how the industry landscape is gradually evolving away from the traditional network in which large pharmaceutical companies drove drug discovery output. Now, interorganisational deals among more diverse players have become active and are driving R&D productivity for startups in biotechnology and pharmaceuticals.
A clear increase in the number of academia-owned spinouts of advanced technology and expansion of investment in start-ups is a positive sign. The emergence of new chemical modalities, such as biologics, oligonucleotides, and peptides that differ from traditional small molecule drug discovery indicate remarkable changes that have taken place over the past two decades. The trend of increased financing for start-up companies in personalised drug development is beneficial for patent creation and will positively impact innovation creation in the coming years.
“The presence of academia to support the technologies of these start-ups is becoming very important, and government and private support and investment in this area is boosting innovation. Our study shows that such medium- and long-term support may ultimately benefit the health and well-being of humankind,” concludes an optimistic Dr Kodama.
Over the past few decades, health care integration has absorbed physician practices and hospitals into large health systems, a practice which was heralded as the way to cut health care costs and boosting quality of care.
But integrated health systems appear to be failing on both fronts, according to the results of a new US study published in JAMA. For patients in health systems, care is only marginally improved while costs are significantly higher compared to those at independent practices or hospitals.
In the US, health systems have grown exponentially in size and market share through mergers and acquisitions of physician practices and hospitals and the joining of separate health systems.
Proponents of consolidation have argued over the years that physicians and hospitals working together in integrated, coordinated systems provide better patients care while being more efficient than independent physician practices and hospitals. This would drive quality of care up while keeping spending steady and even driving costs down.
“One of the key arguments for hospital mergers and practice acquisition was that health systems would deliver better-value care for patients. This study provides the most comprehensive evidence yet that this isn’t happening,” said study first author Nancy Beaulieu at Harvard Medical School.
Today, these systems are responsible for a large proportion of the medical care delivered in the US, some employing thousands of physicians. But despite their impact on population health and the economy, little is known about the actual performance of integrated health organisations, the study authors noted.
A lack of detailed data on performance and scale is a key obstacle. The current analysis is believed to be the first comprehensive national study to compare outcomes between patients receiving care within health systems and outside of them, including patients with private insurance as well as traditional Medicare, which is the US health insurance system for those over 65 or which certain disabilities or conditions.
The analysis included a total of 580 health systems, accounting 40% of physicians and 84% of general acute care hospital beds. Academic and large nonprofit systems accounted for a majority of system physicians (80%) and system hospital beds (64%).
System hospitals were larger than hospitals than nonsystem ones, with 67% of system hospitals having more than 100 beds, while only 23% of nonsystem hospitals having more than 100 beds. System physician practices were also more likely to have more than 100 physicians compared with nonsystem practices (74% vs 12%). Integrated systems delivered primary care to 41% of traditional Medicare beneficiaries.
As for quality and cost of care delivered within systems, patients with primary care physicians in health systems reported slightly better satisfaction and overall care experience than patients of independent physicians.
This is the case even though many patients with nonsystem primary care providers also receive some of their care in hospitals or specialist practices that are part of a health system. However, care in systems came at a much higher price, contributing to higher overall spending on health care, the research showed.
Prices for services from physicians and hospitals within health systems were significantly higher than for independent healthcare, the study found. Physician services delivered within health systems cost between 12% and 26% more, compared with independent practices. System-based hospital services cost an average of 31% more than care delivered by independent hospitals.
Small differences in quality combined with large differences in cost of care suggests that health systems have not, on average, realised their potential for better care at equal or lower cost, the researchers said.
Members of the research team have compiled a database from various sources to help characterise these health systems and to link claims data with information on health care providers in and out of health systems. The database, housed at NEBR, will be made available for free to other researchers in the near future.
“There’s no question that large, sophisticated health systems have benefits over independent systems,” said study author David Cutler, Harvard economic professor. “Big systems tend to be less vulnerable to economic downturns and they can provide specialised care that would be difficult to maintain in smaller systems. But the hoped-for cost savings benefits of integrated health systems have not yet materialised.”
Research on fungi has helped transform tough-to-recycle plastic waste from the Pacific Ocean into key components for making pharmaceuticals, using a genetically altered version of an everyday soil fungus, Aspergillus nidulans. The researchers described their chemical-biological approach in Angewandte Chemie, a journal of the German Chemical Society.
“What we’ve done in this paper is to first digest polyethylenes using oxygen and some metal catalysts – things that are not particularly harmful or expensive – and this breaks the plastics into diacids,” said co-author Berl Oakley, professor at the University of Kansas.
Next, long chains of carbon atoms resulting from the decomposed plastics were fed to genetically modified Aspergillus fungi. The fungi, as designed, metabolised them into an array of pharmacologically active compounds, including commercially viable yields of asperbenzaldehyde, citreoviridin and mutilin.
Unlike previous approaches, Oakley said the fungi digested the plastic products quickly, like “fast food.”
“The thing that’s different about this approach is it’s two things – it’s chemical, and it’s fungal,” he said. “But it’s also relatively fast. With a lot of these attempts, the fungus can digest the material, but it takes months because the plastics are so hard to break down. But this breaks the plastics down fast. Within a week you can have the final product.”
The KU researcher added the new approach was “bizarrely” efficient.
“Of the mass of diacids that goes into the culture, 42% comes back as the final compound,” he said. “If our technique was a car, it would be doing 200 miles per hour, getting 60 miles per gallon, and would run on reclaimed cooking oil.”
Previously, Oakley has worked with corresponding author Clay Wang of the University of Southern California to produce about a hundred secondary metabolites of fungi for a variety of purposes.
“It turns out that fungi make a lot of chemical compounds, and they are useful to the fungus in that they inhibit the growth of other organisms – penicillin is the canonical example,” Oakley said. “These compounds aren’t required for the growth of the organism, but they help either protect it from, or compete with, other organisms.”
Oakley’s lab at KU has honed gene-targeting procedures to change the expression of genes in Aspergillus nidulans and other fungi, producing new compounds.
The researchers focused on developing secondary metabolites to digest polyethylene plastics because those plastics are so hard to recycle. For this project, they harvested polyethylenes from the Pacific Ocean that had collected in Catalina Harbor on Santa Catalina Island, California.
“There’ve been a lot of attempts to recycle plastic, and some of it is recycled,” Oakley said. “A lot of it is basically melted and spun into fabric and goes into various other plastic things. Polyethylenes are not recycled so much, even though they’re a major plastic.”
The KU investigator said the long-term goal of the research is to develop procedures to break down all plastics into products that can be used as food by fungi, eliminating the need to sort them during recycling.
“I think everybody knows that plastics are a problem,” Oakley said. “They’re accumulating in our environment. There’s a big area in the North Pacific where they tend to accumulate. But also you see plastic bags blowing around – they’re in the rivers and stuck in the trees. The squirrels around my house have even learned to line their nest with plastic bags. One thing that’s needed is to somehow get rid of the plastic economically, and if one can make something useful from it at a reasonable price, then that makes it more economically viable.”
Public transport is used by more than 10 million commuters in South Africa every day. It’s how people get to work, how they get to the grocery store, how they get their children to school. It’s quite simply a way of life.
For many of these commuters, there is no alternative to minibus taxis. They are an indisputably dominant pillar of the informal public transport system, but they are also notoriously unsafe. The constant threat of an accident is a real concern for commuters, especially those who cannot afford private medical aid.
“We live in a country where 73% of the population doesn’t have access to private medical aid. Couple this with the high number of road accidents in South Africa, and what recourse do the vast majority of commuters have if they are involved in a road accident?” asks Rikus Scheepers, managing director at AcciCare Medical Service Providers.
AcciCare is a medical funding company that assists people who do not have medical aid, to get access to private hospital care when they are involved in a motor vehicle accident. Scheepers started AcciCare in 2017, with the intention of making private medical care accessible to all commuters.
“We started AcciCare in a few hospitals and had limited capital to work with but soon realised the extensive need for this type of service. As a start-up without a long trading history, it became impossible to grow the business to meet the demand. We needed a business partner who shared our vision to supply this essential service throughout the country, and so we approached Standard Bank,” says Scheepers.
“AcciCare is a unique concept not offered in South Africa,” says Jocelyn Hamilton at Standard Bank. “When they approached us for finance we had to apply some out-the-box thinking in order to provide a working capital solution that would enable the business to grow and expand into more provinces in the country.”
In the event a person is injured in a motor vehicle accident, AcciCare will assist treating doctors and hospitals to collect and complete the correct documentation in order for medical costs to be claimed back from the Road Accident Fund (RAF). AcciCare provides financial assistance to these service providers, so they don’t carry the costs while waiting for the RAF to settle accounts.
“We firmly believe that all commuters should have access to private medical care when they need it the most. Through our partnership with Standard Bank we are expanding our footprint and we have exciting initiatives in place for 2023, to educate more people about the reliable private care that is available to them,” says Scheepers. “Together with Standard Bank, AcciCare has saved countless lives and has significantly improved the quality of life of those who have unfortunately been involved in a motor vehicle accident.”
“Our business banking model is centred on partnering with clients to grow their businesses in the communities in which they exist. While we came in as a working capital solution that would see AcciCare achieve their vision, in return we indirectly partnered in improving the long-term quality of life for those unfortunate enough to be in need of medical care at critical times. We hope to continue with this partnership, as they take their business to new heights,” says Hamilton.
After a trial stretching out from before the COVID pandemic, Elizabeth Holmes, the former CEO of diagnostic biotech startup Theranos, has been sentenced to 11 years after being found guilty of fraud.
In 2018, she was indicted along with Ramesh “Sunny” Balwani on four counts of wire fraud and conspiracy to commit wire fraud in connection with the collapse of Theranos, and was found guilty in January this year. She had been seeking a retrial since she had been contacted by a key witness, former Theranos lab director Adam Rosendorff, who she claimed had recanted statements made under oath.
Before Theranos’s collapse, Rosendorff had previously supplied information for an investigative series into the struggling biotech firm’s Previously, the university dropout had been widely lauded as an innovator and an inspiration for women in technology.
In his remarks during the sentencing of Holmes, US District Judge Edward Davila said, “The tragedy of this case is that Ms. Holmes is brilliant. She had creative ideas. She is a big thinker. She was a woman moving into an industry that was dominated by, and let’s face it, male ego. That young women entrepreneurs are regrettably denied access to, but she made that.”
Judge Davila sentenced her to 135 months (11 years and three months) in prison. Holmes will report to serving her sentence on April 27, 2023, at a minimum-security women’s prison less than 160km from her native Houston, Texas.
The pharmaceutical industry is facing a serious challenge as it struggles to source enough non-human primates (NHPs) such as macaques for research and testing. Alongside demand created by HIV/AIDS research, the pandemic has tightened supplies of the animals further as China, a major supplier, has clamped down on exports.
Since NHPs have great genetic and physiological similarity to humans, scientists use these animals, most commonly rhesus macaques, to study medical conditions and conduct trials which are not yet possible in humans. In 2019, US scientists used 68 257 NHPs in research, according to US government data.
As a result of this shortage, many projects may not be able to be completed, according to industry insiders, with implications for medical research. Pre-pandemic prices of $11 000 per macaque have risen to $35 000.
In July last year, Nature reported that the US government pledged to increase funding to make primates available for clinical research. However, this would not do anything to address the current shortage.
To make room for more NHPs, the US National Institutes of Health (NIH) has invested about US$29 million to refurbish housing, build outdoor enclosures and making other infrastructure improvements at the US National Primate Research Centers (NPRCs), which it funds.
“A couple of years ago, we were feeling the pinch,” Nancy Haigwood, director of the Oregon NPRC in Beaverton, which houses about 5 000 non-human primates. But because of the pandemic, “we are truly out of animals”, she told Nature. “We’re turning away everyone.”
China had been a cheap source of cynomolgus macaques (Macaca fascicularis) since 1985, but in 2013 began to prioritise local research, restricting exports. Adding to this was soaring demand was sparked by multiple NIH grants awarded in 2016 to study HIV/AIDS, according to a 2018 report. Housing and feeding NHPs is costly, and NPRCs could not expand due to budget caps. The report warned of a coming shortage of various primates in coming years.
The situation has drawn the public’s attention – and opposition. Complaints made to airlines has resulted in many no longer carrying the animals, making transportation a major challenge. Air France was one of the last holdouts, and last year said it would stop carrying NHPs for research purposes.
With the arrival of the pandemic and the need for NHP research and testing, vaccine research was naturally prioritised, while trying to supply other projects as well.
When COVID hit, China completely suspended exports of macaques, hitting pharmaceutical companies hardest, which prefer that species for drug trials. Even if the export ban were to be lifted, the Chinese demand for macaques in research is so high that there would be few available for export: of 30 000 macaques that became suitable for use in research last year, 28 000 were used.
Other restrictions constrain the supply, such as a European Union requirement that all non-human primates for research come from self-sustaining colonies by November this year. The UK also carried through this directive following its exit from the EU.
In a research letter published in JAMA Internal Medicine, researchers compared the prices of 120 medications commonly used in humans and pets. The authors found human medication prices were typically higher than the price of pet medications – with the same ingredients at common human-equivalent doses.
While some medications are common to both pets and humans, but price differences can be extreme. In 1991, levamisole (introduced in the 1960s as a veterinary antiparasitic) demonstrated efficacy in treating human colon cancer. The introductory human price of Janssen’s Ergamisol (brand-name levamisole; $5 per 50mg tablet) was 100 times the then veterinary price (approximately $0.05 for an equivalent amount). With the COVID pandemic, a misinformation-driven demand for ivermectin as a COVID treatment led to people seeking veterinary formulations of the drug, increasing the price 15-fold over a month ($6 to $92 for 3 tubes). In this cross-sectional study, the researchers sought to compare prices of commonly prescribed medications used to treat both humans and pets.
The researchers from the University of Minnesota found that retail price for human medications was on average 5.5 times higher than pet medications. For more than 60% of medications, even discounted prices for humans were higher than pet prices. On average, discounted prices were 1.5 times higher for human medications than for pet medications.
‘’A 10-day supply of the same medication costs $2 for a pet dog, $10 for a person with a discount coupon, and $100 for a person without a coupon,” said Arjun Gupta, MBBS, assistant professor at the U of M Medical School and oncologist with M Health Fairview. He is also a member of the Masonic Cancer Center. “With many humans and pets uninsured or underinsured, it is important that cash prices for medications are affordable and that pricing is not exploitative.”
Human prices were also higher than pet prices for drugs such as antibiotics. Researchers warn this may promote humans sourcing antibiotics for their own use from pet sources, especially since human antibiotic use is more regulated.
Exactly why there is such a significant price difference is unclear. One possibility may be drug manufacturers engaging in price discrimination by charging consumers different prices in different markets for the same product, the researchers suggest. Additionally, price differences could reflect variations in medication effectiveness, willingness to pay, and manufacturing, storage, and regulatory standards.
Further research is suggested to explore the causes of price differences.
