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Keeping clinical trial data safe – handling cybersecurity in a risky world

The development of vaccines for COVID-19 has been a masterclass in effective collaboration and applied digitisation in healthcare.
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The development of vaccines for COVID-19 has been a masterclass in effective collaboration and applied digitisation in healthcare. However the increased complexity and involvement of different parties, exposes manufacturers to heightened threat levels. Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats.

A process that historically would have taken at least eight years took around ten months to complete, thanks to close cooperation and effective data exchanges between researchers, business partners, governments and international institutions. By mid-May 2021, seven different COVID vaccines were in use in at least one country, and close to 1.5 billion doses were administered to people worldwide.

Both the breakneck speed and scale of this vaccine generation and distribution were remarkable and encouraging for the future development of treatments for various conditions. They highlight the importance of mastering two positive and related trends in healthcare right now: close collaboration across increasingly complex supply chains and sophisticated use of data.

These trends combine to increase the pace of innovation and the precision of therapies. Leading academic research institutions and pharma/biopharma players exploring therapeutic areas such as immuno-oncology or cell and gene therapy no longer start ‘analogue only’ projects because of time and productivity shortcomings. Instead, principal investigators start with protocols designed with digital techniques in mind.

However, data-intensive, decentralised clinical trials also present a major risk to healthcare participants through cybercrime and data privacy vulnerability. As healthcare organisations scale up digital transformation initiatives, novel problems arise: how to share data without exposing intellectual property or patient data to bad actors?

And how is accountability for a safe and reliable collaboration changing? Evidence demonstrates there is a cost to be paid when these questions go unanswered, given the impunity with which attackers operate.

Many still think of the traditional, vertically integrated ‘Big Pharma’ corporation developing therapies and manufacturing drugs in-house. In today’s landscape, though, the average number of supply chain participants in healthcare for both R&D and Manufacturing is proliferating, often as a result of specialisation and concentration on core competencies.

This demands that organisations collaborate with others in their ecosystem to fill in the gaps. Consider how manufacturing capacity constraints required dynamic contracting to keep pace with demand in the early months of the coronavirus pandemic, including active collaboration among traditional rivals. New technologies and improved data flows among areas – for example, for production planning – are seen as essential to increased agility and will consequently become more widely used.

Clinical trial records often include very detailed information about individuals: habits and genetic information about a patient or their immune system. Criminals target healthcare organisations to gain access to these sensitive individual records – Protected Health Information (PHI), Personally Identifiable Information (PII) or Personal Credit Information (PCI) – but also for their intellectual property or trade secrets.

All are highly attractive because they are readily marketable. Studies reveal that 90% of cyber-attacks on healthcare organisations were financially motivated (Verizon, CrowdStrike). ISTARI research and DarkOwl reports show that transactions involving a health record priced them 7x higher than an equivalent financial record due to health records’ granularity and specificity.

As a result, cyber attacks within the healthcare and pharmaceutical industries have become more frequent and damaging. A recent study by BlueVoyant revealed that 16 out of 20 companies in the sector had mid- to high exposure to basic and advanced threats. If even a major health tech company such as IQVIA, which participated in AstraZeneca’s COVID vaccine trials, can be targeted, forcing researchers to track their patients using pen and paper, what of smaller companies down the chain?

Governments and regulatory bodies endeavour to improve cybersecurity by establishing stringent compliance requirements. However, it is vital to understand that compliance is not security. HIPAA in the United States, a regulatory reference, was designed to protect patient privacy but not necessarily data security. For example, it does not check password re-use or the usage of data-loss prevention tools. Regulation lags well behind risk in the dynamic bad-actor landscape and is not designed to provide guidance on enabling technical safeguards. Additionally, compliance is expensive to maintain, and information (including that of threats) remains siloed.

Therefore, it is up to individual organisations to foster a culture of resilience and vigilance, especially in those areas that work with sensitive patient and trial information, going well beyond compliance to consider what assets are most valuable for trade in the dark web. As a Global Pharma CIO, I have learned the hard way that preparation is the best defence.

  • Executive leadership and collaboration. There is a misconception that cyber resilience is driven solely by technology. In practice, the first step is to recognise it as a business imperative to be led from the top. Which are the crown jewels most worth defending? In addition, advancing the training, habits and alertness of teams adds a strong layer of defence towards improving the specificity and speed of response. The ISTARI CORE-S framework provides actionable guidelines to help executives lead with personal conviction towards better business outcomes.
  • Breach response. Executives should assume a breach is a matter of when, not if. Preparing for an incident includes checking your incident response capability and testing the chain of command. How confident are you in your data backups? Are you otherwise prepared to pay a ransom?
  • Supply chain and vendors. Urgently expand your understanding of third-party risk to consider second-and third-tier suppliers. Hold these global organisations accountable to improvement and highlight coaching and supplier-development opportunities. How is the Value at Risk distributed across your extended ecosystem?

Determined senior leadership combined with today’s cyber technology solutions and a programmatic approach across the supply chain can protect the reputation of clinical trials, the principal investigators, the company and, most importantly, the data of the participating clinicians and patients. These are the crown jewels of any R&D organisation. Treat them as such. Successful leaders recognise the competitive advantage of building cyber resilient organisations and how they enable highly performant business strategy.

About the author

Abel Archundia is the managing director of Global Life Sciences & Industrials at ISTARI, a cyber risk management company focused on building cyber resilience for businesses.

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Middle-aged Americans in US are stressed and struggle with physical and mental health – other nations do better

Adults in Germany, South Korea and Mexico reported improvements in health, well-being and memory.

Middle age was often a time to enjoy life. Now, it brings stress and bad health to many Americans, especially those with lower education levels. Mike Harrington/Getty Images

Midlife was once considered a time to enjoy the fruits of one’s years of work and parenting. That is no longer true in the U.S.

Deaths of despair and chronic pain among middle-aged adults have been increasing for the past decade. Today’s middle-aged adults – ages 40 to 65 – report more daily stress and poorer physical health and psychological well-being, compared to middle-aged adults during the 1990s. These trends are most pronounced for people who attained fewer years of education.

Although these trends preclude the COVID-19 pandemic, COVID-19’s imprint promises to further exacerbate the suffering. Historical declines in the health and well-being of U.S. middle-aged adults raises two important questions: To what extent is this confined to the U.S., and will COVID-19 impact future trends?

My colleagues and I recently published a cross-national study, which is currently in press, that provides insights into how U.S. middle-aged adults are currently faring in relation to their counterparts in other nations, and what future generations can expect in the post-COVID-19 world. Our study examined cohort differences in the health, well-being and memory of U.S. middle-aged adults and whether they differed from middle-aged adults in Australia, Germany, South Korea and Mexico.

A middle-aged woman looking sad sitting in front of artwork.
Susan Stevens poses for a photograph in her daughter Toria’s room with artwork Toria left behind at their home in Lewisville, N.C. Toria died from an overdose. Eamon Queeney/For The Washington Post via Getty Images

US is an outlier among rich nations

We compared people who were born in the 1930s through the 1960s in terms of their health and well-being – such as depressive symptoms and life satisfaction – and memory in midlife.

Differences between nations were stark. For the U.S., we found a general pattern of decline. Americans born in the 1950s and 1960s experienced overall declines in well-being and memory in middle age compared to those born in the 1930s and 1940s. A similar pattern was found for Australian middle-aged adults.

In contrast, each successive cohort in Germany, South Korea and Mexico reported improvements in well-being and memory. Improvements were observed in health for each nation across cohorts, but were slowed for Americans born in the 1950s and 1960s, suggesting they improved less rapidly than their counterparts in the countries examined.

Our study finds that middle-aged Americans are experiencing overall declines in key outcomes, whereas other nations are showing general improvements. Our cross-national approach points to policies that could could help alleviate the long-term effects arising from the COVID-19 pandemic.

Will COVID-19 exacerbate troubling trends?

Initial research on the short-term effects of COVID-19 is telling.

The COVID-19 pandemic has laid bare the fragility of life. Seismic shifts have been experienced in every sphere of existence. In the U.S., job loss and instability rose, household financial fragility and lack of emergency savings have been spotlighted, and children fell behind in school.

At the start of the pandemic the focus was rightly on the safety of older adults. Older adults were most vulnerable to the risks posed by COVID-19, which included mortality, social isolation and loneliness. Indeed, older adults were at higher risk, but an overlooked component has been how the mental health risks and long-haul effects will likely differ across age groups.

Yet, young adults and middle-aged adults are showing the most vulnerabilities in their well-being. Studies are documenting that they are currently reporting more psychological distress and stressors and poorer well-being, compared to older adults. COVID-19 has been exacerbating inequalities across race, gender and socioeconomic status. Women are more likely to leave the workforce, which could further strain their well-being.

A older women hugs her daughter.
Middle-aged people often have parents to take care of as well as children. Ron Levine/Getty Images

Changing views and experiences of midlife

The very nature and expectations surrounding midlife are shifting. U.S. middle-aged adults are confronting more parenting pressures than ever before, in the form of engagement in extracurricular activities and pressures for their children to succeed in school. Record numbers of young adults are moving back home with their middle-aged parents due to student loan debt and a historically challenging labor and housing market.

A direct effect of gains in life expectancy is that middle-aged adults are needing to take on more caregiving-related duties for their aging parents and other relatives, while continuing with full-time work and taking care of school-aged children. This is complicated by the fact that there is no federally mandated program for paid family leave that could cover instances of caregiving, or the birth or adoption of a child. A recent AARP report estimated that in 2020, there were 53 million caregivers whose unpaid labor was valued at US$470 billion.

The restructuring of corporate America has led to less investment in employee development and destabilization of unions. Employees now have less power and input than ever before. Although health care coverage has risen since the Affordable Care Act was enacted, notable gaps exist. High numbers of people are underinsured, which leads to more out-of-pocket expenses that eat up monthly budgets and financially strain households. President Biden’s executive order for providing a special enrollment period of the health care marketplace exchange until Aug. 15, 2021 promises to bring some relief to those in need.

Promoting a prosperous midlife

Our cross-national approach provides ample opportunities to explore ways to reverse the U.S. disadvantage and promote resilience for middle-aged adults.

The nations we studied vastly differ in their family and work policies. Paid parental leave and subsidized child care help relieve the stress and financial strain of parenting in countries such as Germany, Denmark and Sweden. Research documents how well-being is higher in both parents and nonparents in nations with more generous family leave policies.

Countries with ample paid sick and vacation days ensure that employees can take time off to care for an ailing family member. Stronger safety nets protect laid-off employees by ensuring that they have the resources available to stay on their feet.

In the U.S., health insurance is typically tied to one’s employment. Early on in the COVID-19 pandemic over 5 million people in the U.S. lost their health insurance when they lost their jobs.

During the pandemic, the U.S. government passed policy measures to aid people and businesses. The U.S. approved measures to stimulate the economy through stimulus checks, payroll protection for small businesses, expansion of unemployment benefits and health care enrollment, child tax credits, and individuals’ ability to claim forbearance for various forms of debt and housing payments. Some of these measures have been beneficial, with recent findings showing that material hardship declined and well-being improved during periods when the stimulus checks were distributed.

I believe these programs are a good start, but they need to be expanded if there is any hope of reversing these troubling trends and promoting resilience in middle-aged Americans. A recent report from the Robert Wood Johnson Foundation concluded that paid family leave has a wide range of benefits, including, but not limited to, addressing health, racial and gender inequities; helping women stay in the workforce; and assisting businesses in recruiting skilled workers. Research from Germany and the United Kingdom shows how expansions in family leave policies have lasting effects on well-being, particularly for women.

Middle-aged adults form the backbone of society. They constitute large segments of the workforce while having to simultaneously bridge younger and older generations through caregiving-related duties. Ensuring their success, productivity, health and well-being through these various programs promises to have cascading effects on their families and society as a whole.

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Frank J. Infurna receives funding from the National Institute on Aging and previously from the John Templeton Foundation. The content is solely his responsibility and does not necessarily represent the official views of the funding agencies.

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Does a plant-based diet really help beat COVID-19?

A new paper suggests that plant- and fish-based diets lessen the chance of developing severe symptoms – but hold off from becoming vegetarian or pescatarian for now.

Dejan Dundjerski/Shutterstock

Since the beginning of the pandemic, it’s been suggested that certain foods or diets may offer protection against COVID-19. But are these sorts of claims reliable?

A recent study published in BMJ Nutrition, Prevention and Health sought to test this hypothesis. It found that health professionals who reported following diets that are vegetarian, vegan or pescatarian (those that exclude meat but include fish) had a lower risk of developing moderate-to-severe COVID-19.

Additionally, the study found that those who said they eat a low-carbohydrate or high-protein diet seemed to have an increased risk of contracting moderate-to-severe COVID-19.

This may make it sound like certain food preferences – such as being vegetarian or a fish eater – may benefit you by reducing the risk of COVID-19. But in reality, things aren’t so clear.

Self-reporting and small samples

First, it’s important to underline that reported diet type didn’t influence the initial risk of contracting COVID-19. The study isn’t suggesting that diet changes the risk of getting infected. Nor did it find links between diet type and length of illness. Rather, the study only suggests that there’s a link between diet and the specific risk of developing moderate-to-severe COVID-19 symptoms.

It’s also important to consider the actual number of people involved. Just under 3,000 health professionals took part, spread across six western countries, and only 138 developed moderate-to-severe disease. As each person placed their diet into one of 11 categories, this left a very small number eating certain types of diet and then even smaller numbers getting seriously ill.

A man eating a burger and chips
It’s hard to assess the true quality of people’s diets without monitoring what they actually eat. veryulissa/Shutterstock

This meant, for instance, that fish eaters had to be grouped together with vegetarians and vegans to produce meaningful results. In the end only 41 vegetarians/vegans contracted COVID-19 and only five fish eaters got the disease. Of these, just a handful went on to develop moderate-to-severe COVID-19. Working with such small numbers increases the risk of a falsely identifying a relationship between factors when there isn’t one – what statisticians call a type 1 error.

Then there is another problem with studies of this type. It’s observational only, so can only suggest theories about what is happening, rather than any causality of diet over the effects of COVID-19. To attempt to show something is actually causal, you ideally need to test it as an intervention – that is, get someone to switch to doing it for the study, give it time to show an effect, and then compare the results with people who haven’t had that intervention.

This is how randomised controlled trials work and why they are considered the best source of evidence. They are a much more robust method of testing whether one single thing is having an effect on something else.

Plus, there is also the problem that the diet people say they consume may not be what they actually eat. A questionnaire was used to find out what foods people ate specifically, but responses to this were also self-reported. It also had only 47 questions, so subtle but influential differences in people’s diets may have gone unnoticed. After all, the foods available in the US do differ from those available in Spain, France, Italy, the UK and Germany.

So what does this tell us?

When it comes to trying to determine the best diet for protecting against COVID-19, the truth is we don’t have enough quality data – even with the results of this study, which are a small data set and only observational.

And a further issue is that the study didn’t look at the quality of people’s diets by assessing which foods they actually ate. This is another reason why it needs treating with caution. Self-declared diet types or food questionnaires may not capture information on the variety and type of foods eaten – for instance missing details about how much fresh or processed food someone eats, how meals are eaten and with whom. And as alluded to above, self-reported data on what people eat is also notoriously inaccurate.

The bottom line is: the name of what you call your diet is far less important than what you actually eat. Just because a diet is vegetarian or pescatarian doesn’t automatically make it healthy.

A table of friends eating a variety of food dishes
Eating a varied, balanced diet is a route to general good health. Rawpixel.com/Shutterstock

For now, the robust evidence isn’t there to suggest that being vegetarian or pescatarian protects against COVID-19 – so there’s no need to rush to switch your diet as a result of this study. However, what we do know is that keeping active, eating a sensible healthy diet and keeping our weight in check helps to fortify us against a wide range of health issues, and this could include COVID-19.

Perhaps the best advice is simply to keep following general dietary guidelines: that is, that we should eat a variety of foods, mainly vegetables, fruit, pulses, nuts, seeds and whole grains, with few highly processed foods that are high in sugar, salt and fat.

Duane Mellor has written commissioned articles about supplements for Kinerva and he has supported the production of educational resources for the Vegan Society. He is a member of the British Dietetic Association and Association for Nutrition. He also chooses to follow a vegetarian diet.

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FDA authorizes about 10M J&J vaccine doses, trashes 60M more from troubled Emergent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.
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The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Peter Marks, FDA

“This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements,” said CBER director Peter Marks.

Emergent previously ruined 15 million doses of J&J’s Covid-19 vaccine in March due to the cross-contamination with the AstraZeneca vaccine, which was previously made at the same Baltimore site. In April, Emergent slammed the brakes on all production there, at the FDA’s behest, and J&J took control of the plant.

Now, the 10 million doses that are OK to be used may also be exported, but the FDA said Friday that will come with conditions. For instance, for any export of these two batches OKed for use, or of vaccine manufactured from these batches, J&J and Emergent agreed that the FDA may share relevant information, under an appropriate confidentiality agreement, with the regulatory authorities of the countries in which the vaccine may be used.

Additional batches are still under review, FDA said, but the agency declined to say how many or even how many doses are in one batch. The New York Times first reported on Friday that the FDA would not allow the use of the 60 million doses. J&J did not respond to a request for comment.

The European Medicines Agency also released a statement on Friday, saying that based on available information, batches of the vaccine released in the EU are not affected by the cross-contamination that occurred at the Emergent facility.

“However, as a precaution and to safeguard the quality of vaccines, the supervisory authorities [the medicines authorities in Belgium and the Netherlands who are responsible for batch release in the EU] have recommended not releasing vaccine batches containing the active substance made at around the same time that the contamination occurred,” the EMA said.

Additionally, the FDA has extended the expiration dating for the refrigerated J&J doses, after reviewing information and determining that the vaccine can be stored at 2-8 degrees Celsius for 4.5 months, instead of 3 months.

More than 10 million people in the US have now received the J&J vaccine, all of whom received vaccines made at the company’s plant in the Netherlands. Another 10 million more doses have been delivered across the country but not administered yet, according to the CDC.

As of the end of May, 2 million doses of the J&J vaccine have been administered in the EU, EMA said.

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