BU Research Blog

In the last few years, the use of 3D printing has exploded in medicine. Engineers and medical professionals now routinely 3D print prosthetic hands and surgical tools. But 3D printing has only just begun to transform the field.

Today, a quickly emerging set of technologies known as bioprinting is poised to push the boundaries further. Bioprinting uses 3D printers and techniques to fabricate the three-dimensional structures of biological materials, from cells to biochemicals, through precise layer-by-layer positioning. The ultimate goal is to replicate functioning tissue and material, such as organs, which can then be transplanted into human beings.

We have been mapping the adoption of 3D printing technologies in the field of health care, and particularly bioprinting, in a collaboration between the law schools of Bournemouth University in the United Kingdom and Saint Louis University in the United States. While the future looks promising from a technical and scientific perspective, it’s far from clear how bioprinting and its products will be regulated. Such uncertainty can be problematic for manufacturers and patients alike, and could prevent bioprinting from living up to its promise.

From 3D printing to bioprinting

Bioprinting has its origins in 3D printing. Generally, 3D printing refers to all technologies that use a process of joining materials, usually layer upon layer, to make objects from data described in a digital 3D model. Though the technology initially had limited applications, it is now a widely recognized manufacturing system that is used across a broad range of industrial sectors. Companies are now 3D printing car parts, education tools like frog dissection kits and even 3D-printed houses. Both the United States Air Force and British Airways are developing ways of 3D printing airplane parts.

In medicine, doctors and researchers use 3D printing for several purposes. It can be used to generate accurate replicas of a patient’s body part. In reconstructive and plastic surgeries, implants can be specifically customized for patients using “biomodels” made possible by special software tools. Human heart valves, for instance, are now being 3D printed through several different processes although none have been transplanted into people yet. And there have been significant advances in 3D print methods and software in areas like dentistry over the past few years. Visit sites like https://cloud9.software/how-to-manage-successful-dental-practice/ to know more about dental software.

Bioprinting’s rapid emergence is built on recent advances in 3D printing techniques to engineer different types of products involving biological components, including human tissue and, more recently, vaccines.

While bioprinting is not entirely a new field because it is derived from general 3D printing principles, it is a novel concept for legal and regulatory purposes. And that is where the field could get tripped up if regulators cannot decide how to approach it.

State of the art in bioprinting

Scientists are still far from accomplishing 3D-printed organs because it’s incredibly difficult to connect printed structures to the vascular systems that carry life-sustaining blood and lymph throughout our bodies. But they have been successful in printing nonvascularized tissue like certain types of cartilage. They have also been able to produce ceramic and metal scaffolds that support bone tissue by using different types of bioprintable materials, such as gels and certain nanomaterials. A number of promising animal studies, some involving cardiac tissue, blood vessels and skin, suggest that the field is getting closer to its ultimate goal of transplantable organs.

We expect that advancements in bioprinting will increase at a steady pace, even with current technological limitations, potentially improving the lives of many patients. In 2019 alone, several research teams reported a number of breakthroughs. Bioengineers at Rice and Washington Universities, for example, used hydrogels to successfully print the first series of complex vascular networks. Scientists at Tel Aviv University managed to produce the first 3D-printed heart. It included “cells, blood vessels, ventricles and chambers” and used cells and biological materials from a human patient. In the United Kingdom, a team from Swansea University developed a bioprinting process to create an artificial bone matrix, using durable, regenerative biomaterial.

‘Cloneprinting’

Though the future looks promising from a technical and scientific perspective, current regulations around bioprinting pose some hurdles. From a conceptual point of view, it is hard to determine what bioprinting effectively is.

Consider the case of a 3D-printed heart: Is it best described as an organ or a product? Or should regulators look at it more like a medical device?

Regulators have a number of questions to answer. To begin with, they need to decide whether bioprinting should be regulated under new or existing frameworks, and if the latter, which ones. For instance, should they apply regulations for biologics, a class of complex pharmaceuticals that includes treatments for cancer and rheumatoid arthritis, because biologic materials are involved, as is the case with 3D-printed vaccines? Or should there be a regulatory framework for medical devices better suited to the task of customizing 3D-printed products like splints for newborns suffering from life-threatening medical conditions?

In Europe and the U.S., scholars and commentators have questioned whether bioprinted materials should enjoy patent protection because of the moral issues they raise. An analogy can be drawn from the famed Dolly the sheep over 20 years ago. In this case, it was held by the U.S. Court of Appeals for the Federal Circuit that cloned sheep cannot be patented because they were identical copies of naturally occurring sheep. This is a clear example of the parallels that exist between cloning and bioprinting. Some people speculate in the future there will be ‘cloneprinting,’ which has the potential for reviving extinct species or solving the organ transplant shortage.

Dolly the sheep’s example illustrates the court’s reluctance to traverse this path. Therefore, if, at some point in the future, bioprinters or indeed cloneprinters can be used to replicate not simply organs but also human beings using cloning technologies, a patent application of this nature could potentially fail, based on the current law. A study funded by the European Commission, led by Bournemouth University and due for completion in early 2020 aims to provide legal guidance on the various intellectual property and regulatory issues surrounding such issues, among others.

On the other hand, if European regulators classify the product of bioprinting as a medical device, there will be at least some degree of legal clarity, as a regulatory regime for medical devices has long been in place. In the United States, the FDA has issued guidance on 3D-printed medical devices, but not on the specifics of bioprinting. More important, such guidance is not binding and only represents the thinking of a particular agency at a point in time.

Cloudy regulatory outlook

Those are not the only uncertainties that are racking the field. Consider the recent progress surrounding 3D-printed organs, particularly the example of a 3D-printed heart. If a functioning 3D-printed heart becomes available, which body of law should apply beyond the realm of FDA regulations? In the United States, should the National Organ Transplant Act, which was written with human organs in mind, apply? Or do we need to amend the law, or even create a separate set of rules for 3D-printed organs?

We have no doubt that 3D printing in general, and bioprinting specifically, will advance rapidly in the coming years. Policymakers should be paying closer attention to the field to ensure that its progress does not outstrip their capacity to safely and effectively regulate it. If they succeed, it could usher in a new era in medicine that could improve the lives of countless patients.

Online misinformation works, or so it would seem. One of the more interesting statistics from the 2019 UK general election was that 88% of advertisements posted on social media by the Conservative Party pushed figures that had already been deemed misleading by the UK’s leading fact-checking organisation, Full Fact. And, of course, the Conservatives won the election by a comfortable margin.

Internet firms such as Facebook and Google are taking some steps to limit political misinformation. But with Donald Trump aiming for reelection in 2020, it seems likely we’ll see just as many false or misleading statements online this year as in the past. The internet, and social media in particular, has effectively become a space where anyone can spread any claim they like regardless of its veracity.

Yet to what degree do people actually believe what they read online, and what influence does misinformation really have? Ask people directly and most will tell you they don’t trust the news they see on social media. And a landmark study in 2019 found 43% of social media users admitted to sharing inaccurate content themselves. So people are certainly aware in principle that misinformation is common online.

But ask people where they learned about the “facts” that support their political opinions, and the answer will often be social media. A more complex analysis of the situation suggests that for many people the source of political information is simply less important than how it fits with their existing views.

Spurious thinking

Research into the UK Brexit referendum and 2017 general election found that voters often reported making their decisions based on highly spurious arguments. For example, one voter argued that Brexit would stop the takeover of the British high street by foreign companies such as Costa Coffee (which was British at the time). Similarly, a Remain voter spoke of mass deportations of any non-UK born resident if the country left the EU, a much more extreme policy than anything actually put forward by politicians during the campaign.

During the 2017 election, various claims were made by survey respondents that unfairly questioned Conservative leader Theresa May’s humanity. For example, some falsely argued she enacted laws that led to flammable cladding being placed on the exterior of Grenfell Tower, the London block of flats that caught fire in June 2017, killing 72 people. Others called her Labour opponent Jeremy Corbyn a terrorist sympathiser, or a victim of a conspiracy to discredit him by the military and industrial elites. The common thread was that these voters gained the information to support their arguments from social media.

How do we explain the apparent paradox of knowing social media is full of misinformation and yet relying on it to form political opinions? We need to look more widely at what has become known as the post-truth environment. This involves a scepticism of all official sources of news, a reliance on existing beliefs and biases formed from deeply held prejudices, and a search for information that confirms bias as opposed to critical thinking.

People judge information on whether they find it believable as opposed to whether it is backed by evidence. Sociologist Lisbet van Zoonen calls this the replacement of epistemology – the science of knowledge – with “i-pistemology” – the practice of making personal judgements.

A lack of trust in elite sources, in particular politicians and journalists, doesn’t fully explain this large-scale rejection of critical thinking. But psychology can provide some potential answers. Daniel Kahneman and Amos Twersky developed a series of experiments that explored under what conditions humans are most likely to jump to conclusions about a specific topic. They argue intelligence has little impact on making ill-informed judgements.

Intelligence tests demonstrate the capacity to perform logical reasoning, but cannot predict that it will be performed at every moment it is needed. As I have argued, we need to understand the context of people’s decisions.

The average undecided voter is bombarded with arguments from political leaders, especially in marginal seats or swing states that can make a difference to the outcome of an election. Every politician offers a redacted account of their or their opponents’ policies. And voters are aware that each of these politicians is trying to persuade them and so they retain a healthy scepticism.

The average voter also has a busy life. They have a job, perhaps a family, bills to pay and hundreds of pressing issues to address in their daily lives. They know the importance of voting and making the right decision but struggle to navigate the contested election communication they receive. They want a simple answer to that age-old conundrum, who most or who least deserves my vote.

So instead of conducting a systematic critical analysis of every piece of evidence they encounter, they look for specific issues that they see as driving a wedge between the competing politicians. This is where fake news and disinformation can be powerful. As much as we like to think we’re good at spotting fake news and being sceptical of what we’re told, we’re ultimately susceptible to whatever information makes it easiest to make a decision that seems right, even if in the long term it may be wrong.

Darren Lilleker, Associate Professor of Political Communication, Bournemouth University

This article is republished from The Conversation under a Creative Commons license. Read the original article.