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There’s still a lot we need to figure out about e-cigarettes when it comes to their health impacts. But smoking definitely kills, and regulators in the US have a new plan for tackling the problem.
The US Food and Drug Administration (FDA) has just announced a comprehensive new roadmap for regulating tobacco products, and they have dramatically shifted their focus to nicotine addiction. And as part of the new plan, some of last year’s stringent regulations on vaping are going to be relaxed.
The FDA regulations for e-cigarette products were announced last May, and they were so stringent that some people were worried it could wipe out the burgeoning industry, despite the fact there’s evidence vaping does help smokers with quitting.
But now the agency is changing tack, putting nicotine at the heart of the issue and admitting that when it comes to ways of delivering this addictive substance, there’s a spectrum of methods – and some, like traditional cigarettes, are far more unhealthy than others.
“It’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine,” said FDA commissioner Scott Gottlieb.
“Even with unanswered questions about benefits and risks, there are now different technologies to deliver nicotine for those who need it, that doesn’t bring with it the deadly consequences of burning tobacco and inhaling the resulting smoke.”
At the heart of FDA’s new strategy will be a push to lower nicotine levels in traditional cigarettes to levels that won’t cause addiction. The long-term goal here is to prevent young people from getting hooked when they try their first smoke.
“I’ve seen the science in this area and believe it holds much promise,” said Gottlieb.
“We intend to take a hard look at the existing published literature on this important topic and hear from stakeholders, which could provide the basis for regulatory action.”
And while the tobacco industry will be forced to cut back on addictive nicotine levels in their products, the manufacturers of e-cigarettes have been granted an extension on applications for product approval.
“The FDA is committed to encouraging innovations that have the potential to make a notable public health difference,” the agency explained in a statement.
“This action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive.”
But it doesn’t mean the agency is enabling a vaping boom. The agency will still work to develop product standards that will prevent known e-cigarette risks, such as exploding batteries or preventing children from getting easy access to all those sweet-smelling e-cigarette liquids.
On top of that, the FDA will be seeking public input on several aspects of the new plan, including the question of whether the flavouring of tobacco products – say, menthol or cherry cigarettes – makes them more enticing to young people.
They will also look into the best approaches to regulating e-cigarette flavours like bubblegum and gummy bear, which could be appealing to kids.
While the FDA won’t encourage you to go and vape to your heart’s content, it’s certainly a shift towards recognising that e-cigarettes are an innovative way to deliver nicotine, and that regulators need to tackle them differently.
“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users,” said Gottlieb.
“Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use.
“Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.”
But we still don’t know why.
The thought of a cupcake, skillfully frosted with fluffy vanilla icing, may put a smile on your face, but research suggests that, in the long term, a sweet tooth may turn that smile into a frown – but not for the reasons you think.
In a new study, published in Scientific Reports, my colleagues and I found a link between a diet high in sugar and common mental disorders.
The World Health Organisation recommends that people reduce their daily intake of added sugars (that is, all sugar, excluding the sugar that is naturally found in fruit, vegetables and milk) to less than 5 percent of their total energy intake.
However, people in the UK consume double – in the US, triple – that amount of sugar. Three-quarters of these added sugars come from sweet food and beverages, such as cakes and soft drinks. The rest come from other processed foods, such as ketchup.
At the same time, one in six people worldwide suffers from a common mental disorder, such as a mood or anxiety disorder. Could there be a link between high sugar consumption and common mental disorders?
Earlier research, published in 2002, examined the link between depression and sugar consumption in six countries. The researchers, from Baylor College in the US, found that higher rates of refined sugar consumption were associated with higher rates of depression.
Since then, a handful of studies have investigated the link between added sugar consumption and subsequent depression.
In 2011, researchers in Spain found that when they grouped participants based on their commercial baked food consumption, those who ate the most baked food had a 38 percent increased chance of developing depression compared with those in the group with the lowest intake.
The association remained even after accounting for health consciousness and employment status.
In 2014, researchers studied the association between sweetened beverages in a large US group. They found that sugar-sweetened and artificially sweetened drinks (diet drinks) could increase a person’s risk of developing depression.
And, more recently, a 2015 study, including nearly 70,000 women, found higher chances of depression in those with a high added sugar intake, but not in those with a high intake of naturally occurring sugars, such as those found in fruit.
Trying to explain the link
We are still not sure what causes depression, but some researchers believe that biological changes are at the root of it. Some of these changes could be influenced by sugar and sweet taste.
For example, a study in rats found that diets high in sugar and fat can reduce a protein called BDNF that influences the growth and development of nerve cells in the brain. This protein is thought to be involved in the development of depression and anxiety.
Another possible biological cause is inflammation. High sugar diets can increase inflammation – a protective reaction of the body, normally directed against microorganisms or foreign substances.
While common signs of inflammation, such as redness, are far from a mood disorder, the symptoms that keep us in bed with a cold are much closer, such as low energy and being unable to concentrate.
Ongoing research suggests that mood disorders could be linked with inflammation, at least in some cases.
Dopamine is another possible culprit. A study using rats earned headlines for suggesting sweet foods could be as addictive as cocaine.
This might be due to affects on dopamine, a brain chemical involved in the reward system. Dopamine is also thought to influence mood. And addiction is itself associated with a higher risk of developing a mood disorder.
Finally, sugar intake could be associated with other factors, such as obesity, which itself is related to mood.
But these associations could also reflect a reverse phenomenon: low mood could make people change their diet. Sweet foods could be used to soothe bad feelings by providing a short-term mood boost.
And low mood and anxiety could make simple tasks, such as grocery shopping or cooking, so difficult and exhausting for the sufferer that they might start to avoid them. Instead, they might opt for junk food, takeaways and ready meals – all of which have a high sugar content.
What our study adds to the debate
For our latest study, my colleagues and I put the reverse association idea to the test. We used sugar intake from sweet food and drinks to predict new and recurrent mood disorders in a group of British civil servants.
We also investigated whether having a mood disorder would make people more inclined to choose sweet foods and drinks.
We found that men without a mood disorder who consumed over 67g of sugar had a 23 percent increased risk of suffering from a mood disorder five years later, compared with those who ate less than 40g.
This effect was independent of the men’s socioeconomic status, physical activity, drinking, smoking, other eating habits, body fatness and physical health.
We also found that men and women with a mood disorder and a high intake of sugar from sweet food and drinks were at higher risk of becoming depressed again five years later, compared with those who consumed less sugar.
But this association was partly explained by their overall diet.
We found no evidence for a potential reverse effect: participants did not change their sugar intake after suffering from mood disorders.
Despite our findings, a number of questions remain about whether sugar makes us sad, whether it affects men more than women, and whether it is sweetness, rather than sugar itself, that explains the observed associations.
What is certain, though, is that sugar is associated with a number of health problems, including tooth decay, type 2 diabetes and obesity. So cutting down on sugar is probably a good idea, regardless of whether it causes mood disorders or not.
New kidneys from scratch.
Body organs such as kidneys, livers and hearts are incredibly complex tissues. Each is made up of many different cell types, plus other components that give the organs their structure and allow them to function as we need them to.
For 3D printed organs to work, they must mimic what happens naturally – both in terms of arrangement and serving a biological need. For example, a kidney must process and excrete waste in the form of urine.
Our latest paper shows a new technique for 3D printing of cells and other biological materials as part of a single production process. It’s another step towards being able to print complex, living structures.
But it’s not organ transplants we see as the most important possible consequence of this work.
There is already evidence that 3D cell printing is a technology useful in drug development, something that may reduce the burden on animals for testing and bring new treatments to market more quickly and safely.
How we 3D bioprint
Add “biology” (that is, cells) to the printing technique and it becomes an entirely new process: 3D bioprinting.
3D bioprinting requires sterile conditions to avoid contamination of the bioprinted sample, and an appropriate temperature and humidity so the cells don’t die. Also, the plastic materials traditionally used in 3D printing cannot be used in bioprinting, as they require high temperatures or toxic solvents.
We and other researchers around the world are developing materials that can be manipulated in a 3D printer while causing minimal harm to the cells.
However, each cell type that makes up the different tissues of the human anatomy requires a unique mechanical environment. Each requires unique structural supports to function normally.
As an example, bones are a resistant and brittle material, muscles of the heart are elastic, tough materials, and internal organs such as the liver are soft and compressible.
In a recent publication, we and our colleagues show that new materials extracted from marine algae can be used to 3D bioprint human stem cells in distinct environments, and without harming the cells. We believe that these findings pave the way toward the printing of complex tissue structures.
Hoping for new organs
Currently, patients needing replacement organs must wait for availability (from living or deceased donors) and are then required to be on immunosuppressive drugs for most of the rest of their lives, causing side effects and creating a tremendous cost for the healthcare system.
But printing of entire organs is an incredibly complex process, one that takes weeks of time that a patient may not have up his or her sleeve.
Also, while this process is somewhat advanced for relatively simple tissues such as skin, the next phase of the technology requires incorporation of nerves, blood vessels and lymphatic vessels that would integrate with the host system to create transplantable whole organs such as kidneys, lungs, hearts or livers.
We’re probably many many years and millions of dollars away from being able to bioprint whole, functional human organs.
But there’s another way bioprinted cells can be used: for testing new drugs in the laboratory.
Bioprinted cells for drug testing
Using current methods, bringing a new drug to market has been estimated to cost US$2.5 billion, and can take more than ten years from start to finish.
Even if you manage to identify a new candidate drug, the likelihood of regulatory approval is low: in 2016, less than 10 percent were approved.
When starting human clinical trials, the probability of a drug to make it to the market is between 10 and 15 percent depending on the type of molecule , with illness or even death for participants.
We know that these drugs mainly fail due to poor efficacy in humans despite promising results in animals. This disconnect is due to the different physiology between species: rodents and other trial animals are very different from humans in many key ways.
3D printing technology allows us to print more complex 3D models that reproduce aspects of the liver, kidneys or heart muscles that are suitable to test and identify novel pharmaceutical molecules. These models are already starting to be used by multinational pharmaceutical companies.
While the use of animals in research is still inevitable, the regulatory agency the Food and Drug Administration and its new director have already started to consider integrating alternatives for drug safety and efficacy assessment.
Toward the end of the animal testing?
In 2013 the European Union passed a new law prohibiting the use of animal testing for cosmetic development on its territory, and of retailing products tested abroad on animals.
This regulation has accelerated the development of human-based 3D models of skin for the testing of new cosmetic formulations. These resolutions were accepted because the technology was available and has enabled a reduction in the number of research animals.
This is about to be translated in Australia as well.
The changes operated in other industries combined with the exciting technological advances let us have a glance at how 3D bioprinting may be able to contribute to faster and cheaper ways to create effective new drugs.