The World Health Organisation (WHO) estimates that up to half a million people develop multidrug-resistant tuberculosis every year. And laboratory confirmed cases of particular resistant strains have increased 600-fold in the UK between 2003 and 2015.

The rise in multidrug-resistant bacteria is usually attributed to the overuse of antibiotics in human medicine and farming. A new study, published in the journal Infection, suggests that there is a third source: globalised drug manufacturing.

Drug manufacturing has undergone significant changes in recent decades. For example, many companies have started to outsource the production of active pharmaceutical ingredients (APIs) to Asia. Antibiotics form an important part of what is now a global industry.

China and India are currently the world’s largest API producers in a market that was worth US$160 billion in 2016. But along with such impressive growth there has been a loss of transparency and oversight. The API supply chain is enormously complex and assessing production standards is one of the big challenges the industry faces. Controls are being performed by the WHO as well as regulatory bodies. But these checks usually focus on the purity and the safety of the substances produced, not on environmental issues.

Significant pollution

There is often significant pollution near drug production sites in India and China. This is mostly due to insufficient waste water management. The new study by Christoph Lübbert and colleagues, along with a second report by the Changing Markets Foundation, is the first systematic analysis of whether this pollution is associated with the presence of multidrug-resistant bacteria.

The new study focused on Hyderabad, a hub for bulk drug manufacturing in India. The researchers collected and tested a total of 28 samples for the presence of drug resistant bacteria. Sixteen of these samples were also tested for antimicrobial substances. Roughly half the samples were taken from sewers and other sites in the vicinity of bulk drug-making plants. The other half were taken from areas in and around Hyderabad.

All environmental samples tested showed high levels of antimicrobial substances. This included a sample from the Musi river, which passes through the centre of the city. Worryingly, in more than 95% of these samples the researchers also found multidrug-resistant bacterial strains. This included strains that are resistant to last-line antibiotics, such as carbapenems.

Worrying findings

These findings are worrying as they confirm that the drug-making sites can create a potent breeding ground for multidrug-resistant bacteria. This matters because drug-resistant bacteria are not just a local issue. Not only can resistance genes transfer from one bacterium to another via horizontal gene transfer, bacteria also travel easily in the guts of healthy humans. This vastly accelerates the global spread of locally produced resistances.

The threat to global health has been recognised by international bodies. The WHO has called for a multinational effort to tackle the issue. And the G20 health ministers recently decided to make multidrug-resistant bacteria the focus of their agenda.

But both the G20 and the WHO aim their efforts heavily on the issue of overuse. The report by Lübbert and colleagues adds a new layer to the problem as it suggests that the emergence of antimicrobial resistance is also a consequence of globalised drug manufacturing.

They call on Western authorities and pharmaceutical companies to ensure that more stringent environmental controls are put in place. Production plants will have to be updated. And more costly waste management must be reinforced. Otherwise, the authors claim, the global threat of multidrug-resistant bacteria cannot be efficiently tackled.

• Stephan Guttinger is a Research Fellow, Philosophy of Science, University of Exeter
• This article was originally published on . It is reproduced here with a short summary and an extra subhead for ease of reading.
• For more on this topic see also the report How dirty production of NHS drugs helps create superbugs – produced by the Bureau of Investigative Journalism

Looking forward in science in part requires looking back and evaluating trends and using these to predict future outcomes.

In a new study, researcher Rolf Halden, PhD, from Arizona State University’s Biodesign Institute,  has used this premise to examine the trajectory of chemicals  from their launch into the marketplace to the appearance of data  showing them to be emergent threats to human or environmental health. The results are both interesting and frustrating to chemical campaigners and those who are just interested in keeping toxic chemicals out of their lives

Halden analysed 143,000 peer-reviewed research papers representing 60 years worth of data, and tracked the progress of these chemicals of emerging concern(CECs), revealing patters of emergence from obscurity to peak concern and eventual decline, over a span of 30 years.

The study reveals that it typically takes around 14 years from the onset of initial safety concerns about a given chemical to the height of concern and appropriate action. This extended time-line means many more people are exposed to a chemical than probably need to be.

“To better protect human health and the environment, it is desirable to decrease both the number of CECs entering commerce and the time required to take action,” comments Halden.

Halden is the director of Biodesign’s Center for Environmental Security, whose primary focus is “to protect human health and critical ecosystems by detecting, minimising and ultimately eliminating harmful chemical and biological agents through early detection and engineering interventions.”

In past research, his group has evaluated a broad range of common chemicals and assessed their human and environmental impact, including antimicrobial chemicals in personal care products, plastics (and chemicals involved in their fabrication), tobacco, brominated flame retardants and fluorinated synthetic chemicals on prenatal and postnatal health.

Chemical romance

Modern society has grown to depend on an ever-growing range of chemicals. So many are produced and used each year, that preliminary safety testing for human and environmental effects is often inadequate – or simply missing altogether. Unsurprisingly, some of these chemicals return to cause problems, in some cases, severe.

Global industrialisation has placed unprecedented stresses on the environment, with a corresponding impact on human health.

Worldwide, at least one quarter of all human diseases are believed to have an environmental component and CECs represent an important contributing factor. More than 40,000 harmful substances are currently ranked as CECs and around six new compounds of CEC potential are being added to the world’s chemical inventory each day.

The current paper focuses on just 12 CECs: dichlorodiphenyltrichloroethane (DDT), trichloroacetic acid (TCAA), N-nitrosodimethylamine, methyl tert- butyl ether (MTBE), trichloroethylene (TCE), perchlorate, 1,4-dioxane, prions, triclocarban, triclosan, nanomaterials, and microplastics.

While many CECs are used for industrial applications, others (particularly the antimicrobials triclosan and triclocarban) find their way into an array of household products including plastic items, toys and articles of clothing.

The findings reveal that many harmful environmental agents show a common pattern of emergence, rising to a level of peak concern and declining to a baseline level. This fact permits the analysis of prior CEC trends as well as the forecasting of future concern.

A long road

Not only did the study find that it typically takes 14 years from a particular chemical’s emergence from obscurity to the height of concern about its effects, but typically it takes another 14 or 15 years for authorities to do anything about it. Meaning an entire generation will have been exposed to a particular toxin – or group of toxins before action is taken.

Recent studies have suggested that the amount of toxic chemicals the current generation of children are exposed to has resulted in a ‘pandemic’ of brain damage.

It further notes that some chemicals may emerge repeatedly, for example DDT and TCAA.

The new research identifies multiple potential stages a CEC chemical may pass through, as its harmful properties become known to the public and within the scientific community:

• absence of concern due to ignorance of a potential hazard or risk;
• increase in concern upon realization of a potential threat or knowledge gap;
• initial height or peak of concern;
• decrease in concern as a result of accumulating knowledge and risk management strategies, including behavioural changes, exposure control, voluntary phase-out of substances and regulatory actions taken;
• establishment of a new baseline of residual concern;
• potential renewed increase in concern possibly due to novel adverse effects observed;
• second peak of concern;
• decrease to a new baseline level of concern and so on.

The research suggests that the rise and fall in concern for CECs of recent interest may be forecast based on the historic data derived from other CECs. For example, rising concern over the safety of nanomaterials is expected to peak no later than 2016, while microplastics (which only began to raise an alarm in 2008), likely will elicit peak concern in 2022, if current trends continue.

Some things may speed up the decline of certain chemical exposures i.e. better (and more transparent) testing methods, and new manufacturing techniques that provide viable alternatives to CEC use. Publicity efforts driving the public toward or away from particular chemicals are also important.

In fact, the paper notes a dramatic case of how a mixture of public outcry and media attention can work citing the decline in the use of antimicrobial products, including the CEC chemicals triclosan and triclocarban, following vigorous media campaigns.

Halden hopes the data will inform future efforts to safeguard human and environmental health. Areas for improvement include shortening the duration between the emergence of CECs and their withdrawal as well as finding ways to develop new chemical and engineering methods that produce safer chemicals that do not pose a threat to human and environmental wellbeing.

“My hope is that the ‘law of pollutant emergence’ uncovered here will not endure for another 60 years. Green chemistry – the design of inherently safe chemicals – points the way to a future of fewer risks and a healthier planet,” says Halden.

“It’s a goal too important to lose track of.”

In the mean time it’s good to know that public engagement can have an effect on shortening everyone’s exposure to toxic chemicals. Keep shouting!

My wife Lauren and I were thrilled when we had first learned that she was pregnant.  At thirty years old, I really felt like I was finally ready for the responsibility, and that my life was finally going to be complete.

I remember it clearly, as it had been an Easter Sunday when I had told my entire family about the great news.  Four days later it was all over.  My wife had a miscarriage, and all of the great expectations, hopes and dreams about a new day had been dashed.

Even though it was tough to get over it, we did manage to try again and she was able to keep the baby for the full term and our son, Brayden had been born in February 2008.  So, after all of the anxious feelings and words from doctors and specialists about our situation, it seemed like it was going to be smooth sailing for the rest of the way.

Our first had been such a wonderful addition to our family that we decided to try for our second child. Unfortunately, the third pregnancy turned out the same way the first one did, and that is when I got angry.why was this happening?  My wife wanted answers just as badly as I did, and she was the one who set me on a journey of discovery.

Looking at labels

Almost two weeks after her second miscarriage, I had been cleaning up outside of our house, when she lifted up the window and asked me if I knew what was in her acne medication.

Of course, I had absolutely no idea whatsoever, so I quickly replied, “No”.

This was the first time in her life that she looked at label of ingredients on the side of a product that wasn’t food, and she started to look at everything that was in it.  I remember she was having trouble pronouncing some of the chemicals, as many of those she had not ever encountered before.

She found that some of the ingredients had been linked to cancer, or were endocrine disruptors, or could cause organ toxicity or could just cause cellular level changes.

We both sat back and thought to ourselves: “How in the world could we be able to buy something like this?  I thought someone was out there making sure that this kind of thing didn’t happen?  How many other products are like that just in our bathroom?”

A dangerous mixture

So, we started looking all over our house at everything.  From our bedroom to the bathrooms, our kitchen, our clothing, our vehicles, we didn’t want to leave a stone unturned.  We needed to know as much as possible about this, and we had discovered one thing that almost all of the chemicals we were encountering had in common.

From our government in the US, to our companies and our court system, no one really knows the health ramifications of all of these chemicals.  One at a time they may not be a particular problem, but anyone who has taken a elementary school class in chemistry knows that when some chemicals are combined, they can cause adverse reactions.

And the worst part is that many of the 88,000 chemicals that are in our system of commerce today are not regulated at all.

Hitting the road

That is when I had decided that enough was enough, and I hit the road with a camera and decided to speak with the top people in the world about this issue.

Even though I didn’t know everything about this subject, I knew that if I could learn as much as I could from them, I would be able to help my family and other people in a big way through education.

I needed a plan, and it all started, ironically, at The Rodale Institute, which is located in Kutztown, Pennsylvania, which is about 70 miles from where I currently live.  Once there I knew that I was on to something, as I was told that this is a huge issue that people really aren’t aware of, and that no one is really talking about.

Incidentally, The Rodale Institute is the very first institution in the United States that served as a teaching school for farmers to grow crops organically, which had been viewed as counter-productive decades ago when chemical agriculture was becoming more prominent.

Today, I believe that an institution such as The Rodale Institute has proven that it was and always has been futuristic in it’s approach, as we are seeing the damaging results of conventional agriculture daily.

A worldwide problem

I had the opportunity to travel the world, to see a lot of different things and to meet with and film some of the top experts in the world on this issue.

From Ralph Nader (longtime consumer advocate and US Presidential Candidate), Dr. Devra Davis (who helped frame the Toxic Substances contorl Act in the US), Ken Cook (president and co-founder of the Environmental Working Group), Stacy Malkan (co-founder of The Campaign for Safe Cosmetics), Dr. Richard Clapp (epidemiologist and public health expert at Boston University) and Dr. Tyrone Hayes  (a biologist and pesticide expert at the University of California, Berkeley), along with 75 other interviewees, it took a great deal of work to get this project completed.

In my travels, I had the chance to see a lot of the world, as I went to Hawaii, Canada and even the UK and the journey has helped form the perspective that I now carry.

So much more we need to know

As I conducted all of my interviews, many of those I had spoken with were well versed in their own perspective and discipline.  However, by talking and trading information in conversations with many of them off camera, I found I was educating them as much as they were educating me.

This is a complex subject and whether it was pesticides, flame retardants, vaccines, BHA/BHT, food colourings, fluoride, toxic sludge or chlorine, even the most well educated on the issues still had further to go themselves, which I found to be fascinating.

That is why this film is so important, because no matter how much any of us think we know about an issue as big and as complex as this is, there are still aspects of it that need to be considered, and that’s exactly what my movie, Unacceptable Levels, provides.  At heart it’s a simple view by a father, about an extremely complex problem that affects every single life form on this planet, and the real issue is that it happens slowly, and quietly over a long period of time.

I believe that the message is not just about sustainable change, but one of sustaining the changes that we want to see in this world.  That’s going to require a sustained movement of people like you and me.

Or as Dr Seuss says in his seminal book The Lorax:

“Unless someone like you cares a whole awful lot.  Nothing is going to get better.  It’s not”

Among human beings, there used to be common sense precepts that provided guidance, for instance, “Better safe than sorry” and “Look before you leap”.

To this day, doctors still take an oath that promises to “First do no harm”. But if studies show that medical error is in fact the fifth leading cause of death in the US, and the fourth leading cause of death in the UK (see  our chart, Causes of Death in the UK, based on 2011 data from the Office of National Statistics). It is reasonable to wonder just how many take the oath seriously any more.

Although there is a prevailing trend in our culture towards less cautious life philosophies, at heart, most of us want to keep ourselves and our families safe from environmental poisons. Yet, there is still an erroneous belief that environmental toxins are things that are ‘out there’. It’s a belief that makes it difficult to get to grips with the idea that there are no longer any barriers between what is out there in the wider environment and what is polluting the immediate environment in your home, school or office.

Healthier than ever?

Over the years, our lack of care for ourselves, our planet and the wellbeing of future generations has allowed manufacturers to get away with selling us everyday products, including food, cosmetics and household cleaners, that are laced with poisons. It has allowed industry and agriculture to get away with polluting our waterways and soil.

Worse, it has allowed governments to get away with providing heavy subsidies to these polluters while at the same time refusing to fund studies into the cause and effects of pollution, and completely ignoring the impact this environmental onslaught has on the planet and its inhabitants.

As a result, we now live in a world overwhelmed with toxic substances. They are in our air, our water and our food. People who protest against such actions are inevitably labelled hysterics and scaremongers.

We are told repeatedly that humans are healthier now that at any other time during our evolution. And yet, if we are so healthy, why are we popping so many pills? How is it possible that, in 2009 sales for the top 20 drug companies topped $437 (£273) billion,  twice the 2001 figure of $248 (£155) billion. That’s a 56% rise.

For us as individuals it translates into a mind-blowing spend on prescription drugs. America spends $307 billion a year, that’s $841 million a day on mediating it’s people. In the UK according we spend £22 million a day.

Scientific uncertainty

For years, the environmental and public health movements have been struggling to find an idea that will give concerned individuals the opportunity to find their common sense again, a concept that acknowledges, but ultimately overrides, scientific uncertainty about cause and effect, and shifts the burden of proof of relative harm or safety from the consumer to the polluter.

The issue of scientific uncertainty is, in fact, an enormous barrier in the campaign to protect human health from the threat of a toxic environment.

When environmental groups and individuals speak out against potentially harmful practices, they are inevitably asked to supply ‘proof’ of harm (in contrast the polluters, who rarely have to supply data, in some cases, not even safety data for the chemicals they produce or use). Yet, ‘conclusive’ studies – as defined by the medical and scientific communities – into the harmful effects of pesticides, and other harmful substances are sometimes hard to find.

One reason for this is that not all of the current studies into environmental toxins conform to that ‘gold standard’ of medical research, the double-blind, randomised, placebo-controlled trial. Indeed, it may be impossible to construct such a trial around environmental toxins.

Since we are all exposed to a greater or lesser extent, it would be impossible to find a large enough and healthy enough group of non-exposed individuals to compare results with. What’s more, the ethics of exposing trial participants to known carcinogens to see how long it would take for them to become sick would be highly questionable.

These difficulties have, for a very long time, worked in favour of polluters. But don’t fall into the trap of assuming that no clear-cut evidence of harm is the same as evidence of safety.

Likewise, as our understanding of the body grows, it becomes apparent that the harm caused by environmental toxins can, initially, be very subtle.

In contrast, most scientific research is constructed to measure the gross and obvious changes in people’s health, and regulations and other actions to protect human health are usually implemented only after evidence of significant harm – for example, mass deaths and clusters of severe illnesses, usually accompanied by lawsuits – has been established.

Risk analysis

Other hurdles stand in the way of our understanding of the harm caused by environmental toxins. When assessing the harm done by environmental toxins, many government agencies use what is known as ‘risk analysis’ to calculate levels of acceptable risk. Indeed, the idea of acceptable or low risk is enthusiastically sold to the public as a good reason to continue exposing ourselves to certain toxins, such as pesticides or heavy metals.

In addition, when potential hazards are addressed by government agencies, they are usually addressed one at a time, even though none of us is ever exposed to pollutants one at a time. Broader issues, such as the need to promote organic agriculture, to de-escalate our addictions to shopping and to acquiring consumer goods, to encourage the use of non-toxic products and to phase out whole classes of dangerous chemicals are also rarely addressed.

To overcome all these barriers requires new thinking about the nature of ‘evidence’, but also about effective means of protection. In response to this need, a sophisticated version of the old adage “better safe than sorry” has evolved.

The Precautionary Principle

Known as the Precautionary Principle, it is based on the idea of ‘forecaring’ and the knowledge that science, because of its limitations and uncertainties, is simply not able to provide an accurate prediction of future hazards. The Precautionary Principle does not call for an abandonment of science. Instead, it suggests that we:

• take action even in the face of uncertainty
• place the burden of proof of relative safety or harm on the proponents of an activity rather than on the potential victims
• explore alternatives to possibly harmful actions
• use democratic processes, including decision-making that involves the views of those who are most affected.

The Precautionary Principle stands in stark contrast to the ‘acceptable risk’ or ‘risk analysis model’ that is currently used by scientists to reassure the public of the safety of environmental toxins.

Risk analysis – which evolved out of the world of engineering in the 1970s – was and is a good way of measuring things we can know, for instance, the weight a suspension bridge can bear.

But it is a very poor method of calculating subtler, harder to spot, human health risks, such as the effect of certain neurotoxic chemicals on a child’s neurological development (which appears to have more to do with the timing of exposure than with the amount).

With risk analysis, whatever can’t be quantified (that is, reduced to a numerical, statistical risk factor) is simply taken out of the equation as unimportant. But doing so creates large gaps in our understanding, and gives big corporations and government agencies a good excuse to continue moving forward with actions that may well be harmful to human health.

Perhaps most crucially, the Precautionary Principle acknowledges that the nature of what is considered scientific ‘evidence’ has to change. In these days, we must take into account all kinds of data – classical studies, case reports, consumer complaints and more – to arrive at reasonable conclusions.

The Precautionary Principle, which is enshrined in European Law, but not US law, is in part  a rejection of crude ideas of cause and effect as applied to the exquisitely sensitive and complex human body.

It’s a rejection of the idea that the traditional methods of research are the best or only ways to study harm and predict risk, and of the belief that the scientific community is in a strong position to tell the average citizen what risks should and should not be taken.

Each of us has to make up our own minds about risk, and each of us has to take the actions that we feel are appropriate to safeguard our own health.

What a philosophy like the Precautionary Principle brings into the equation is the realisation that the average citizen has the power within their grasp to reject bland assurances of safety in favour of actual proof.

It provides support for the idea that our own environments are our business, and that we can make changes for the better that could have a significant impact on our longer-term health as well as that of future generations.

• Adapted in part from Living Dangerously by Pat Thomas (Gill & MacMillan).

For anyone concerned about the level of toxic chemicals in the environment – and their effects on health – the Swedish government’s recent instruction to its Chemicals Agency to produce and implement a national Action Plan for a Toxin-free Everyday Environment, is good news.

The plan means that hazardous toxins and chemicals are to be identified, restricted and phased out. You can read the report here.

Chemicals affect us at many stages, for instance during their production, via their presence in the products we buy, during their use and as waste. A good example is flame retardants (found in protective clothing and insulation materials) perfluorinated substances (used to repel water, grease and dirt) and certain phthalates, which can be found in plastic flooring and also in adhesives, paints, wallpaper and other products.

Data continues to accumulate that these and other substances, which are so ubiquitous in everyday products, can threaten the environment and diminish human health.

The Swedish action plan aims to reduce our everyday risk of exposure and will undertake special initiatives in six areas:

• Improving knowledge, including of combination effects, whereby individually harmless chemicals can become hazardous when mixed;
• Streamlining EU efforts within REACH (The Registration, Evaluation, Authorisation and restriction of Chemicals initiative which came into force on June 1, 207) to accelerate the identification, restriction and phasing-out of hazardous chemicals;
• Intensifying efforts to remove chemicals in food that pose a hazard to health, such as pesticide residues and cadmium;
• Improving information to consumers on chemicals in products;
• Enhancing product monitoring and improved controls of hazardous substances in products;
• Initiating and supporting voluntary initiatives to restrict, phase out and replace hazardous chemical substances.

The Government is allocating extra 100 million Swedish krona (nearly £10 million) to help produce the action plan. It is also encouraging the business sector, researchers, public authorities and consumer and environmental organisations to get involved and work together.

Sweden has already taken initiative in several areas. The country has implemented a ban on mercury and is working for a corresponding decision in the EU as a step towards a global phase-out of mercury. It has also actively pushed for the EU to ban the endocrine disrupter Bisphenol A which, as a first stage, is now to be banned in baby bottles.

The focus on a toxin-free society in Sweden is the result of long-term planning. It began life as the 1997 Government Environmental Quality Bill, which called for a toxic-free society by the year 2020.

Slow progress? Maybe. But at least it’s progress.

It’s hard to imagine the UK government taking the same interest and initiative when it has yet to even acknowledge that there is a problem with the chemicals in our environment. It remains for progressive countries like Sweden to lead the way.