Day: October 11, 2024

NHI Act Offers no Answer to High Medicines Prices

Photo by Gustavo Fring:

By Fatima Hassan

The National Health Insurance Act does not deal with the systemic issues that cause high prices and inequity in medicine access, and government is not listening, argues Fatima Hassan.

As the department of health lunges forward with implementing a system of National Health Insurance (NHI), with business and other interests trying to thwart that, what lessons from the COVID-19 pandemic can help us to ensure health equity for all – for both users of the public and private health sectors?

A few key themes come to mind: market power, secrecy, transparency, accountability, timely access, and affordability.

COVID’s lessons

The human cost of COVID-19 globally was at least fourteen million people who died in just two years. In South Africa, COVID was the leading cause of death in 2020 and 2021, outstripping deaths due to other diseases in those years.

To mitigate the COVID pandemic and to move forward, we needed vaccines. Then, the creed of intellectual property fundamentalism preached to us by the ultra-wealthy and by pharmaceutical corporations was to tell us to monopolise and privatise the manufacture and supply of publicly created vaccines and medicines, while relying on voluntary market measures – not effective regulation or compulsory measures – to ensure access. That creed failed us.

At the time, agreements with private manufacturers for the supply of vaccines were entered into, and at the request of a very powerful industry, treated as a secret. The Health Justice Initiative (HJI) litigated to compel disclosure, and we won.

Our analysis showed a set of one-sided terms, including conditions that required Non-Disclosure Agreements with significant advance payments without legal obligations on suppliers in terms of delivery volumes or dates. The contracts provided sweeping indemnity terms, limits on international redistribution/donations, and overly broad intellectual property protections. We also found that in several instances, South Africa overpaid for vaccines compared to higher middle income countries.

Where we live

We live in a country with worsening health outcomes, a high burden of HIV and TB, and alarmingly high levels of gender-based violence.

Politically, we have had multiple health ministers in the space of just five years – even during a pandemic – due in part to corruption allegations and now, a new Government of National Unity (GNU). We have an unaccountable rotating door system for appointing ministers, deputy ministers, and health Portfolio Committee members, seriously blurring the Legislature’s oversight function. This is not good governance.

We have outstanding laws and regulations that could address some of the “now” issues but which are not being prioritised. For example, we are still subject to an apartheid-era Patent Law that is deferential to patent seekers, resulting in over patenting or evergreening. Vested interests, we believe, are blocking key amendments that would limit patent protection in favour of the public interest.

We do not have a robust local, properly state-subsidised health manufacturing industry in South Africa, often making us reliant on external manufacturers. We have xenophobia seeping into our health system, where patients have been attacked in state hospitals because of their nationality.

And on top of all of that, we have growing reports not just of provincial health product stockouts but also reports of widespread health sector tender corruption, and targeted assassinations of whistleblowers. Finally, given, among other things, our outdated patent system and inability to reign in medicine prices, our medicine costs are astronomical, needlessly (even when compared to other BRICS countries).

The NHI as the GNU’s test (and ours)

It is in this context, that even before the 2024 national elections, NHI has become a lightning rod of disagreement even within the GNU, including for business, creating a hostile climate for civic engagement. Sadly, the political gamesmanship over NHI especially at the Executive level, is coming across as unaccountable, arrogant, and non-engaging. This will not build our health system. In this debate, government has rarely admitted it made any mistakes so that is why it was surprising that in a recent Bhekisisa interview, the health minister conceded that restricting NHI basic health services (so non-emergency care) to South African ID holders may be self-defeating for public health. He said that that is a “mistake” that needs to be “rectified” in the NHI Act.

NHI and state-led procurement

The NHI Act envisages a single state procurement entity for all health products for NHI users (as selected by a benefits committee). In theory, this should provide greater negotiating power and leverage.

With the lessons of COVID and more recently Mpox, we can expect that may not be so. Even under NHI, there will be a scramble for much needed supplies, where South Africa will have to compete on the international market for often scarce and high priced supplies.

Thus, addressing the pharmaceutical industry’s power, and by virtue of that, the global and local medicine patent (reward) system and its abuse matters – but we need to do it now, not incrementally or at some later or undefined point.

For the NHI to financially sustain itself (and assuming here for a moment that it has sufficient funds to begin with), it will have to either overthrow or better regulate the current medicine over-patenting and pricing transparency system to survive, failing which, NHI money could dry up just on health products and medicine costs alone.

At present, South Africa on average pays more for medicines than comparator countries. Business is eerily silent about this aspect in its critique of NHI. Since medical schemes will continue to operate under NHI for some time, one would expect greater concern about the disproportionate use of scheme members’ resources in this respect too, from business.

On top of this, under an apartheid era drafted law (the Patents Act), South Africa is still also doling out patents allowing companies to evergreen their patents on several essential medicines including for TB and HIV, and cancer with limited regulatory and legal repercussions.

While the HJI vaccine procurement judgment should be having far-reaching implications, not just for the next set of pandemic procurement negotiations, but also for substantial state-led procurement due to take place under NHI, we would be naïve to think that the industry and powerful global and local actors in the pharmaceutical sector will change its ways for the better just because South Africa is implementing NHI.

The NHI, we are told, will be based on the principles of “universality and social solidarity” and will “unify” our health system. Yet, if we focus on just one aspect included in the Act – the medicine access system – it is a far cry from the promised system of unification. This is because it is drafted in a way that by our count and reading, creates at least four medicine access systems, operating in parallel (NHI for NHI users; Medical Schemes for scheme beneficiaries – while schemes are permitted to operate under NHI (could be decades); complementary cover via insurance coverage for NHI users; over the counter via out of pocket payments/insurance coverage for non-NHI users such as foreign workers, foreign students, resident non-nationals, etc.).

Either way, for all of its admirable “equity” intent, NHI in South Africa will be fully dependent on the global medicines access market whether we like it or not because we are not operating in a neutral, access friendly global system. Nor are we operating in a context where the executive has any real, public, and committed plan to drive down medicine prices before or while NHI is implemented – and without business interests interfering in the execution – it is leaving that totally to the market, to whimsical unenforceable donations and voluntary business conduct. That is not sustainable.

The President is fully aware of how the latter affected our vaccine access and procurement strategy and costs in the COVID-19 pandemic. What is he going to do about it?

NHI and “top-ups”

Under NHI, the Act will allow top-up products and complementary cover via insurance offerings to presumably fill the gap for those health products, services or medicines that the state may not select or include in the NHI Formulary because of affordability constraints. So how will those complementary cover products and medicines be priced and regulated? Will the current imperfect and expensive system, called the Single Exit Price System, for non-state medicines be used?

Imperfect, because in South Africa, public sector medicines prices are largely determined by the bids companies submit in response to advertised government tenders. In the private sector, companies are free to launch a medicine at any price, although once launched, annual price increases are regulated – so that every drug in the private sector has a single exit price. In rare cases, excessively high medicine prices have been challenged using competition law, but this is the exception.

There have been moves toward reference pricing – where maximum prices for specific medicines would be determined by reference to prices for that medicine in a basket of other comparable countries – but none of several rounds of regulations proposing such a system have been implemented, mainly because pharmaceutical companies usually litigate against the state to prevent it from implementing such a comparator system – in other words, like elsewhere, while we face exorbitant medicine costs, we also face powerful corporate lobbies that do not want proper transparent systems for setting medicines prices. This only serves a profiteering agenda.

NHI and medicine access questions

Just on the narrow point of medicine access under NHI there are critical issues that need to be clarified. They include the following:

  • Whether we can be guaranteed transparency and information, including about the deliberations of the various NHI ministerial advisory, benefit and selection committees, and procurement structures under the NHI – or will we have to litigate every access to information request, as we did in COVID?
  • How will the NHI Fund (Office of Health Products Procurement) negotiate with the global pharmaceutical industry without, for example, the bullying we witnessed in the COVID-19 pandemic?
  • And specifically for medicines and health products:
    • Will manufacturers be permitted to sell to health providers other than the state? If so, how will this be done, and how will the maximum price be determined or regulated?
    • Which medicines and health products will be covered under NHI benefits as part of the NHI Formulary and how will the price of those not covered (top-ups/complementary cover) be regulated?
    • What role will the current private sector pricing system play including the single exit price system – and how and when will it be amended?

As our country pushes ahead with the NHI, there are some immediate concerns like these that we believe will affect implementation.

Of course, we all support the vision of a unified, equitable health system. But aspirations aside, the NHI Act does not deal with the systemic issues that cause high prices and inequity in access. Instead of investing effort into systems that control prices better at the outset, it is investing in systems to deal with the consequences of unaffordable drugs, hoping for self-correction, all while deferring to powerful vested interests including business lobbies that have the President on speed dial.

Regulatory bodies and civil society actors can only take on the tip of the medicine pricing iceberg – the question to the President is, while the Executive dithers on amending keys laws including the Patents Act, under NHI: who exactly will fight for every single patient and for every single medicine?

Since the NHI Bill was signed into law, the President (and his Cabinet) are now duty bound to take constitutional steps to remedy the deficiencies in the NHI Act, and at the very least, to listen to all sectors, not just business.

*Hassan is director of the Health Justice Initiative. This piece is drawn from her key note address at the 2024  Annual David Sanders Lecture in Public Health and Social Justice hosted by the University of Western Cape’s School of Public Health and Peoples Health Movement South Africa.

Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.

Republished from Spotlight under a Creative Commons licence.

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Common Treatments for Breast Cancer may Speed up Aging

Photo by National Cancer Institute on Unsplash

A new study has revealed that common breast cancer treatments, including chemotherapy, radiation, and surgery, may accelerate the biological aging process in breast cancer survivors. The findings, published in the Journal of the National Cancer Institute, show that markers of cellular aging, such as DNA damage response, cellular senescence, and inflammatory pathways, significantly increased in all breast cancer survivors, regardless of the type of treatment received. This suggests that the impact of breast cancer treatments on the body is more extensive than previously thought.

“For the first time, we’re showing that the signals we once thought were driven by chemotherapy are also present in women undergoing radiation and surgery,” said study lead author Judith Carroll, an associate professor of psychiatry and biobehavioural sciences at UCLA. “While we expected to see increased gene expression linked to biological aging in women who received chemotherapy, we were surprised to find similar changes in those who only underwent radiation or surgery.”

Advances in cancer therapies have greatly improved survival rates, with an estimated 4 million breast cancer survivors in the US today and over 6 million expected by 2040. However, breast cancer is linked to accelerated aging, impacting physical abilities, independence, and lifespan. Biological aging processes, which drive conditions like fatigue, cognitive decline, frailty, and cardiovascular disease, appear to be a major factor. Evidence suggests that cancer treatments, like chemotherapy, can increase the risk of earlier onset of these aging-related conditions, making it crucial to understand the specific pathways involved to better target and manage them.

To examine how gene expression related to aging changes over time in women diagnosed with breast cancer, the team conducted a two-year longitudinal study that tracked women undergoing breast cancer treatment prior to receiving treatment and again following treatment to see how their biological aging markers evolved. 

The team tracked the gene expression in their blood cells using RNA sequencing, focusing on markers that signal biological aging, including a process known as cellular senescence, which is when cells stop dividing but don’t die. These so-called “zombie cells” accumulate over time and can release harmful substances that damage nearby healthy cells, contributing to aging and inflammation.

 The data was then analysed using statistical models to help identify aging-related changes.

The team found that regardless of treatment type there was an increase in expression of genes that track cellular processes involved in biological aging. Specifically, genes that capture cellular senescence and the inflammatory signal from these cells, indicating that their immune cells were aging faster than normal.

They also saw increases in DNA damage response genes, which are genes that are expressed when there is DNA damage. Although chemotherapy did have a slightly different pattern, similar to what others have shown, they also noted changes in women who did not receive chemotherapy. 

“The results suggest women who receive treatment for breast cancer have a pattern of gene expression that indicates increased DNA damage and inflammation, which could be important targets for recovering from cancer and having a better quality of life in survivorship,” said senior author of the study Julienne Bower(Link opens in new window), professor of psychology in the UCLA College and psychiatry and biobehavioural sciences and member of the UCLA Health Jonsson Comprehensive Cancer Center. 

“We’ve only just begun to understand the long-term consequences of cancer therapy and these findings are a critical step toward understanding the biological pathways that drive many post-treatment symptoms in breast cancer survivors,” added Carroll. “Our goal is to find ways to improve survivorship, not just in terms of years lived, but also in quality of life and overall health.”

The team is now exploring a new biomarker that measures a woman’s biological age and the pace at which she is aging. This could help determine whether the aging signals detected during cancer treatment have a long-term effect on biological age. The team plans to investigate factors that may influence this, with a focus on protective behaviours such as exercise, stress management and healthy sleep patterns.

Toothbrushes and Showerheads Teem with Viruses – Perhaps Useful Ones

Photo by Towfiqu barbhuiya: https://www.pexels.com/photo/a-toothbrush-with-toothpaste-on-a-white-surface-12065623/

Step aside, tropical rainforests and coral reefs, the latest hotspot to offer awe-inspiring biodiversity is in your bathroom. In a new study published in Frontiers in Microbiomes, microbiologists found that showerheads and toothbrushes are teeming with an extremely diverse collection of viruses – most of which have never been seen before.

Although this might sound ominous, the good news is these viruses don’t target people. They target bacteria.

The microorganisms collected in the study are bacteriophage, or “phage,” a type of virus that infects and replicates inside of bacteria. Although researchers know little about them, phage recently have garnered attention for their potential use in treating antibiotic-resistant bacterial infections. And the previously unknown viruses lurking in our bathrooms could become a treasure trove of materials for exploring those applications.

“The number of viruses that we found is absolutely wild,” said Northwestern’s Erica M. Hartmann, who led the study, which was published in the journal Frontiers in Microbiomes. “We found many viruses that we know very little about and many others that we have never seen before. It’s amazing how much untapped biodiversity is all around us. And you don’t even have to go far to find it; it’s right under our noses.”

An indoor microbiologist, Hartmann is an associate professor of civil and environmental engineering at Northwestern’s McCormick School of Engineering and a member of the Center for Synthetic Biology.

The return of ‘Operation Pottymouth’

The new study is an offshoot of previous research, in which Hartmann and her colleagues at University of Colorado at Boulder characterized bacteria living on toothbrushes and showerheads. For the previous studies, the researchers asked people to submit used toothbrushes and swabs with samples collected from their showerheads.

Inspired by concerns that a flushing toilet might generate a cloud of aerosol particles, Hartmann affectionately called the toothbrush study, “Operation Pottymouth.”

“This project started as a curiosity,” Hartmann said. “We wanted to know what microbes are living in our homes. If you think about indoor environments, surfaces like tables and walls are really difficult for microbes to live on. Microbes prefer environments with water. And where is there water? Inside our showerheads and on our toothbrushes.”

What they found: An ‘incredible diversity of viruses’

After characterizing bacteria, Hartmann then used DNA sequencing to examine the viruses living on those same samples. She was immediately blown away. Altogether, the samples comprised more than 600 different viruses — and no two samples were alike.

“We saw basically no overlap in virus types between showerheads and toothbrushes,” Hartmann said. “We also saw very little overlap between any two samples at all. Each showerhead and each toothbrush is like its own little island. It just underscores the incredible diversity of viruses out there.”

A potential pathogen fighter

While they found few patterns among all the samples, Hartmann and her team did notice more mycobacteriophage than other types of phage. Mycobacteriophage infect mycobacteria, a pathogenic species that causes diseases like leprosy, tuberculosis and chronic lung infections. Hartmann imagines that, someday, researchers could harness mycobacteriophage to treat these infections and others.

“We could envision taking these mycobacteriophage and using them as a way to clean pathogens out of your plumbing system,” she said. “We want to look at all the functions these viruses might have and figure out how we can use them.”

Avoid overreacting: Most microbes ‘will not make us sick’

But, in the meantime, Hartmann cautions people not to fret about the invisible wildlife living within our bathrooms. Instead of grabbing for bleach, people can soak their showerheads in vinegar to remove calcium buildup or simply wash them with plain soap and water. And people should regularly replace toothbrush heads, Hartmann says. Hartmann also is not a fan of antimicrobial toothbrushes, which she said can lead to antibiotic-resistant bugs.

“Microbes are everywhere, and the vast majority of them will not make us sick,” she said. “The more you attack them with disinfectants, the more they are likely to develop resistance or become more difficult to treat. We should all just embrace them.”

Source: Northwestern University

COVID Infection Linked to MI & Stroke Risk Increases up to 3 Years Later

Photo: CC0

An analysis of data in the UK Biobank has found that COVID infection may increase the risk of myocardial infarction (MI), stroke and death from any cause for up to three years for people with and without cardiovascular disease, according to new research published in the American Heart Association’s peer-reviewed journal Arteriosclerosis, Thrombosis and Vascular Biology (ATVB).

“We found a long-term cardiovascular health risk associated with COVID, especially among people with more severe COVID cases that required hospitalisation,” said lead study author James Hilser, M.P.H., Ph.D.-candidate at the University of Southern California Keck School of Medicine in Los Angeles. “This increased risk of heart attack and stroke continued three years after COVID infection. Remarkably, in some cases, the increased risk was almost as high as having a known cardiovascular risk factor such as Type 2 diabetes or peripheral artery disease.”

Previous research has shown that COVID increases the risk of serious cardiovascular complications within the first month after infection. This study examined how long the increased risk lasted and whether it subsided after recovering from COVID infection.

Researchers reviewed health and genetic data in the UK Biobank for more than 10 000 adults, including approximately 8000 who had tested positive for SARS-CoV-2 from February 1 to December 31, 2020 and about 2000 who tested positive for the virus in a hospital setting in 2020. A group of more than 200,000 adults who had no history of COVID infection during the same time frame in the UK Biobank were also reviewed for comparison. None of the participants were vaccinated at the time of infection because COVID vaccines were not yet available in 2020.

The analysis found:

  • During the nearly 3-year follow-up period, the risk of heart attack, stroke and death was more than two times higher among adults who had COVID, and nearly four times greater among adults hospitalized with COVID, compared with the group with no history of COVID infection.
  • People hospitalized with COVID, without cardiovascular disease or without Type 2 diabetes, had a 21% greater risk of heart attack, stroke and death compared to people with cardiovascular disease and without COVID infection.
  • There was a significant genetic interaction among the non-O blood types and hospitalisation for COVID. People with severe COVID infections had an increased risk of heart attack and stroke, however, that risk was even higher in people who had non-O blood types (those with blood types A, B or AB).
  • The risk of heart attack and stroke was about 65% higher in adults with non-O blood types compared to those who had type O blood. A preliminary analysis did not show that Rh (positive or negative) blood type interacted with severe COVID, the authors noted.

“Worldwide, over a billion people have already experienced COVID infection. The findings reported are not a small effect in a small subgroup,” said co-senior study author Stanley Hazen, M.D., Ph.D., chair of cardiovascular and metabolic sciences in Cleveland Clinic’s Lerner Research Institute and co-section head of preventive cardiology. “The results included nearly a quarter million people and point to a finding of global health care importance that may translate into an explanation for a rise in cardiovascular disease around the world.” 

Study details, background and design:

  • Health data was from the UK Biobank, a large-scale study of 503,325 adults living in the United Kingdom who were 40 to 69 years of age at enrollment between 2006 and 2010. The in-depth health and biomedical information was collected for participants registered in the UK National Health Service with a UK general practitioner (similar to a primary care physician in the U.S.).
  • This analysis included health data for 10,005 adults who tested positive for the COVID virus or were hospitalized with COVID between February 1, 2020, and December 31, 2020. An additional 217,730 peers enrolled in the UK Biobank who did not have COVID during the same time period were included. In the analysis, all participants were matched as closely as possible for demographics and similar health conditions.
  • Major adverse cardiovascular events (heart attack, stroke and all-cause death) were evaluated for long-term risk, through October 31, 2022, approximately 3 years later.

“This interesting paper is really two studies in one,” said Sandeep R. Das, M.D., M.P.H., MBA, FAHA, co-chair of the American Heart Association’s COVID-19 CVD Registry committee and director for quality and value in the cardiology division for UT Southwestern Medical Center in Dallas. “First, the authors show that having been hospitalized with COVID is a marker of increased cardiovascular risk, on par with having a pre-existing diagnosis of cardiovascular disease. Although proving direct cause and effect is very difficult to tease out in a study that only analyses past data collected for other purposes, this finding is important because it suggests a history of prior COVID hospitalization, even without a history of CVD, should be considered to initiate and possibly accelerate CVD prevention efforts. Whether severe COVID infection has a direct impact on the vascular system is an interesting area for study as well,” Das said.

“The second ‘study’ in this paper looks at the relationship between ABO blood type and COVID outcomes. They show that something located close to the genetic home of ABO blood type is associated with different degrees of susceptibility to COVID. This is really fascinating, and I look forward to seeing scientists tease out what the specific pathway may be.”

The study had several limitations, including that the data was from patients who had the original strain of the COVID virus before vaccines were widely available in 2021. Additionally, the researchers noted that UK Biobank information on medication use was not specific to the beginning of the pandemic in 2020 or the date that patients were infected with SARS-CoV-2. Also, because the majority of participants in the UK Biobank are white, additional research is needed to confirm that these results apply to people with diverse racial and ethnic backgrounds.

“The results of our study highlight the long-term cardiovascular effects of COVID infection. Given the increased risk of heart attack, stroke and death, the question is whether or not severe COVID should be considered as another risk factor for CVD, much like Type 2 diabetes or peripheral artery disease, where treatment focused on CVD prevention may be valuable,” said co-senior study author Hooman Allayee, Ph.D., a professor of population and public health sciences at the University of Southern California Keck School of Medicine in Los Angeles. “The results suggest that people with prior COVID infection may benefit from preventive care for cardiovascular disease.”

Source: American Heart Association

MS Associated with an Increased Risk of Certain Cancers

This is a pseudo-coloured image of high-resolution gradient-echo MRI scan of a fixed cerebral hemisphere from a person with multiple sclerosis.

Credit: Govind Bhagavatheeshwaran, Daniel Reich, National Institute of Neurological Disorders and Stroke, National Institutes of Health

A new study has found some cancers to be slightly more frequent in people with multiple sclerosis (MS) than in people without MS. The study is published online in Neurology®, the medical journal of the American Academy of Neurology. Types of cancers found to have a small increased risk include bladder, brain and cervical cancers.

“People with MS undergo an increased number of tests to monitor MS, making it more likely to detect other diseases,” said study author Emmanuelle Leray, PhD, of Rennes University in France. “We found an association between some types of cancer and MS which may have different explanations depending on a person’s age and the types of cancer. Overall, our study found the increased risk of cancer was quite small.”

For the study, researchers reviewed 10 years of data in the French national health care database. Researchers identified 140 649 people with MS and matched them for factors such as age, sex and residence to 562 596 people without MS. All participants were cancer free three years before the study. They were followed for an average of eight years.

During the study, 8,368 people with MS and 31,796 people without MS developed cancer.

Researchers determined there were 799 cancers per 100 000 person-years for people with MS and 736 cancers per 100 000 person-years for people without MS. Person-years represent both the number of people in the study and the amount of time each person spends in the study.

Researchers found people with MS had a 6% increased risk of developing any type of cancer regardless of age, sex and residence. They also found cancer risk was higher in those under 55 and lower in people 65 and older when compared to people without MS.

Researchers then looked at cancer types. People with MS had a 71% increased risk for bladder cancer, a 68% increased risk for brain cancer and a 24% increased risk for cervical cancer. However, they also had a 20% lower risk of prostate cancer, a 10% lower risk of colorectal cancer and a 9% lower risk of breast cancer.

“While our study found a higher risk for brain cancer, it may be due in part to earlier detection in those with MS since they regularly have brain scans which may detect cancers earlier, before a person has symptoms,” said Leray. “Frequent urinary tract infections in people with MS and the use of immunosuppressant drugs may contribute to their higher risk of bladder and cervical cancers.”

Leray added, “The lower risk for colorectal and breast cancers may be due in part to fewer people with MS getting screened for cancer in older age when they may be experiencing more MS symptoms. More research is needed, including studies that look at more closely at how cancer screenings may play a role.”

A limitation of the study was that researchers were unable to adjust for factors such as education, income, smoking and alcohol consumption since this information was not available in the national database.

Source: American Academy of Neurology