In recent years, hundreds of new synthetic recreational drugs have emerged – drugs that neither the general public nor the scientific community know very much about. Many of these new synthetic drugs – often referred to as “legal highs” – are dangerous and continue to lead to poisonings throughout the US and the rest of the world.

These drugs provide similar highs to other, more well-known drugs, like marijuana and cocaine. Many are still legal and others have only recently become illegal.

So why would people use these potentially harmful new drugs?

Drug users in the US have a lot to fear. Users of various drugs have to worry that the products they are using may be adulterated. Many must worry about unintentional poisonings, and (depending on the drug) addiction, as well.

But one of the biggest fears has nothing to do with safety or addiction. With illegal drugs, you are at risk for arrest. A drug-related arrest can prevent an individual from getting a good job, or from obtaining school loans or housing. The stigma associated with being a drug user can also serve as a major disruption to one’s life. A lot of people want to use or sell drugs, but fear repercussions. And that makes using or selling “legal highs” seem like a more attractive option.

But “legal,” in this case, doesn’t mean safe or regulated. Legal synthetic drugs are usually so new that laws to prohibit their use simply don’t (yet) exist. Even though they may be “legal,” these drugs have not gone through safety testing and it’s hard to know what you’re getting, or even where it’s coming from.

Spice, K2 and Scooby Doo – synthetic marijuana

Synthetic cannabinoids (hereafter referred to simply as “synthetic marijuana”), are the most prevalent of these new drugs in the US. Cannabinoids are natural compounds in marijuana that act on specific receptors in the brain. THC, the main psychoactive compound in marijuana, is the cannabinoid largely responsible for getting users high. Synthetic cannabinoids mimic the effects of the natural cannabinoids in marijuana, but have been reported to be much stronger and much more unpleasant than real marijuana.

Synthetic marijuana users rarely know what to expect because the products consist of untested research chemicals sprayed on an herbal mixture. It can be hard to know exactly where these drugs come from – but at least some are coming out of unregulated labs overseas. There are many compounds, mixtures and brands available and they aren’t very difficult to find. They’re widely available over the internet and also sold in some head shops throughout the US. Products come in catchy packaging under popular names such as Spice, K2 and Scooby Doo, and may be particularly appealing to young people. While some compounds are now illegal, they still remain available, and new synthetic (legal) compounds quickly emerge to take their place.

Synthetic marijuana use has been associated with tens of thousands of poisonings throughout the US. Alarmingly, results from my study published earlier this week suggest that between 2011 and 2013, one in ten US high school seniors reported using synthetic marijuana in the last year. In fact, a couple of years ago synthetic marijuana was the second-most prevalent drug used by teens (after real marijuana). However, use has begun to decrease since 2014.

Synthetic marijuana isn’t the only new drug out there

New synthetic drugs are beginning to pop up everywhere. You might have heard of “bath salts,” which are compounds or mixtures of synthetic drugs like the stimulants mephedrone and methylone. New drugs such as bath salts are often sold over the internet with users informed that they are “not for human consumption.” Despite extensive media attention, (intentional) use is not very prevalent.

Currently only about one out of a hundred high school seniors have reported use in the last couple of years. However, unlike synthetic marijuana, which is usually used intentionally, bath salts are often used unintentionally. In recent years, bath salts have been showing up frequently in the drug Molly, which is supposed to be pure MDMA (Ecstasy).

As I’ve discussed in The Conversation and in The Independent, many Molly users in the US don’t know the purity of the product they are using. A lot of batches of Molly have little to no MDMA and users should be worried that their Molly contains more dangerous synthetic chemicals such as methylone. Despite decreasing prevalence in use, “Ecstasy”-related poisonings and deaths have increased in recent years, and it appears that this is a result, in part, of Molly being so adulterated with new synthetic drugs.

Testing synthetic drugs is difficult

It is difficult for users to test their drugs to ensure purity. Special tests are needed to determine which drug is which and testing tends to be very expensive. In fact, testing is so expensive and time-consuming that some autopsies of deaths related to use of new drugs are backlogged or do not include tests for all new synthetic drugs. Making things more dangerous for users, pill and powder testing at rave parties and festivals is discouraged because promoters worry that it will be viewed as condoning drug use or admitting that use is occurring at the party. So those likely to try these new drugs are often stuck gambling with their lives as it is so difficult to test their products.

These new drugs are created in response to our drug policy and new drugs will continue to emerge. It seems that whenever we’re able to push one drug down, a newer, more dangerous synthetic drug, pops up to take its place.

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By Laura Stark, Vanderbilt University and Nancy D Campbell, Rensselaer Polytechnic Institute

Recently, Phase II and III trials of two vaccines for Ebola started in West Africa. The development of possible vaccines is welcome news. Like most vaccine trials, the current Ebola trials are being conducted under ethical guidelines derived from US standards for clinical research in human beings.

Research in humans is a crucial part of our medical system. We need to be able to test that vaccines and drugs are safe and effective in people before they are released to the general public. While standards exist to govern these testing processes, our protections for human subjects of medical experiments are badly outdated.

Vaccines merit public scrutiny especially during the early years of their use and development. Not only are problems most likely to appear while vaccines are being tested, but the volunteers in these early, risky stages often have little political power.

It is useful to look to a vaccine trial conducted 50 years ago where researchers from the US National Institutes of Health studied the effects of a virus called SV40 in human subjects – in this case federal prisoners.

1960 – scientists discover a contaminated vaccine

In 1960 scientists discovered that a vaccine culture used throughout the United States had been contaminated with a monkey virus, SV40. Among other things, this vaccine culture had been used to make polio vaccine that had been given to 98 million Americans – more than half the US population at the time.

The discovery raised major concerns. Scientists knew that SV40 caused cancer-like tumors in lab animals and human tissue. But they did not know how it affected living people. In 1963, scientists gathered in La Jolla, California to discuss the “safety of polio and measles vaccines and their possible contamination by viruses capable of causing cancer in lower forms of animals.”

As we report in a recent article, scientists at the time felt that running a controlled clinical trial was the only way to find a definitive answer. But they also felt it would be unethical to experiment on people if one outcome might be cancer. And then an opportunity to do an “ethical” human trial presented itself.

Using prisoners as guinea pigs

At the same time that the US National Institutes of Health (NIH) learned about the SV40 contamination, NIH scientists were also developing and testing new vaccines on federal prisoners who had volunteered to take part in an intentional infection program. Using prisoners for clinical research was not uncommon at the time. Prior to the 1970s, almost all Phase I and II drug trials were conducted on prisoners.

J Anthony Morris, a molecular biologist at NIH, was testing a new vaccine for the common cold on prisoners. And SV40, the same virus that had contaminated the polio vaccine, had also stowed away in the experimental vaccine Morris was using. Since the prisoners had already been exposed to SV40 once by mistake, scientists decided they had a rare opportunity. Morris and his team created a controlled study to examine the affects of SV40 in humans.

To their relief they found that while SV40 affected the prisoners’ immune response, it fell beneath the threshold of clinical notice. They felt confident that any accidental low dose of SV40 – in polio vaccine, for example – would not affect people’s long-term health.

Government epidemiologists tracked cancer rates in the US population to be sure there was no spike in the disease for people who had received the contaminated polio vaccine. By the end of the 1960s, epidemiologists had found no observable effect of SV40 at the population level. The polio vaccine was safe, and other contaminated vaccines, too.

Our ethical standards are better, but not by much

Our goal here is not to argue about the safety of vaccines routinely given in the US – they are safe – or about the safety of the Ebola vaccines being tested.

Since the 1960s, our knowledge about vaccines has improved, and our standards for vaccine trials have evolved. The people used in the 1960s vaccine research — namely, prisoners — were eventually safeguarded under regulations for the protection of human subjects of medical research, which passed in the 1970s.

Now almost 50 years later, the US Office of Human Research Protections has stated that these old rules are inadequate to protect human subjects. Yet research on human subjects has radically expanded both the numbers of human subjects and the transnational reach of the old rules. The US government knows that at the least they need better ways to track adverse events and inform participants about results. They need earlier warning systems and the resources for more systematic governance of clinical trials.

Despite the deficiencies in our human research protocols, medical researchers in other countries have followed US human subject protections since the 1970s. The regulatory apparatus is lagging to such an extent that in 2011, the US government pledged to revise the rules to account for new populations and methods used in 21st century medical experiments. Yet these outdated rules remain unchanged today.

Phase I and II trials are the riskiest, the first tests of new drugs that are done in human beings. In the United States these tests tend to be done on people with little money and lots of time out of the workforce – the very people who most need protection.

Turning our eye to the Ebola trials, we must ask who is taking part and how they will be protected. Experiments for the Ebola vaccine are at risk of being done with the best of intentions on people susceptible to the disease by virtue of geopolitical location and a history of inequality.

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By Miriam Boeri, Bentley University

In the 1930s, Harry J. Anslinger, the first head of the Federal Bureau of Narcotics, embarked on a fierce anti-marijuana campaign. Highlighted by the 1936 anti-marijuana film Reefer Madness – where marijuana is depicted as a dangerous narcotic that makes good kids become sex-crazed killers – his propaganda efforts also maliciously linked marijuana use to African Americans and ethnic minorities.

By 1970, legislation codified cannabis as one of the nation’s most dangerous drugs: the Controlled Substance Act classified marijuana as a Schedule 1 drug, meaning it possessed high potential for abuse and had no acceptable medical use. Over 40 years later, the classification remains.

But research has shown that marijuana, while still criminalized at the federal level, can be effective as a substitute for treating opioid addicts and preventing overdoses. Massachusetts, which recently legalized medical marijuana – and where heroin overdoses have soared – could be a fertile testing ground for this potentially controversial treatment.

The medical case for marijuana

Before being criminalized, marijuana was used in the US to cure depression and a variety of other mental health ailments. Many studies have supported the therapeutic benefits of cannabinoids, along with the ability of marijuana’s psychoactive ingredients to treat nausea, help with weight loss, alleviate chronic pain, and mitigate symptoms of neurological diseases.

Other research, however, contradicts claims regarding the benefits of cannabidiol treatment. Some say marijuana actually poses a risk for psychosis and schizophrenia. Although the FDA has approved some synthetic cannabinoids for medical treatment, federal agencies do not support marijuana as a legitimate medicine until more clinical studies have been conducted.

The scientific debate over the harms and benefits of marijuana has impeded federal lawmakers from moving forward on marijuana legislation reform. As a result, in 23 states, medical marijuana has become legalized by popular vote.

Marijuana policy dilemma

With each state crafting unique medical marijuana regulations, we find ourselves at a crucial turning point in drug policy. Public health professionals claim the road map used by “big tobacco” will be copied with legal marijuana, and addiction rates for marijuana will increase to those we see for tobacco. Others warn that if medical marijuana is used indiscriminately and without focused education on the uses and forms of medical marijuana, a prescription pain pill-like crisis could occur.

Among drug treatment specialists, marijuana remains controversial. Although some research has shown marijuana to be an alternative treatment for more serious drug addiction, addiction treatment specialists still view marijuana as highly addictive and dangerous. These views handicap policy reform, but despite its status as a Schedule 1 drug, recent research shows marijuana could be part of the solution to the most deadly drug epidemic our country has seen in decades.

Massachusetts: a case study

In 2012 Massachusetts became the 18th state to legalize medical marijuana, though the first 11 dispensaries are not scheduled to open until sometime in the coming year. This situation presents an opportunity to implement sensible, research-based policy.

Massachusetts, like many states across the US, has seen a dramatic rise in opioid addition fueled by the increase in opiate prescription pills. In Boston, heroin overdoses increased by 80% between 2010 and 2012, and four out of five users were addicted to pain pills before turning to heroin.

Meanwhile, the leading cause of death among the Boston’s homeless population has shifted from AIDS complications to drug overdoses, with opiates involved in 81% of overdose deaths. This is an alarming finding given recent expansion in clinical services for the city’s homeless.

Addiction specialists and health care professionals in Boston have been at the forefront of integrating behavioral and medical care. Naloxone and methadone are currently the main solutions to address the growing opiate addiction and overdose problem. But Naloxone is an overdose antidote, not a cure or a form of preventative therapy.

Methadone, like heroin and other opioids, has a very narrow therapeutic index (the ratio between the toxic dose and the therapeutic dose of a drug). This means that a small change in dosage can be lethal to the user. Marijuana, however, has one of the safest (widest) therapeutic ratios of all drugs.

Research shows that marijuana has been used as a form of self-treatment, where users take cannabis in lieu of alcohol, prescription opiates, and illegal drugs. That’s one reason why researchers are calling for marijuana to be tested as a substitute for other drugs. In this capacity, marijuana can be thought of as a form of harm reduction. While researchers don’t seek to discount some of the drug’s potential negative effects, they view it as a less damaging alternative to other, harder drugs. Despite these findings, marijuana is rarely incorporated in formal drug treatment plans.

A recent study might change this policy. Comparing states with and without legalized medical marijuana, it found a substantial decrease in opioid (heroin and prescription pill) overdose death rates in states that had enacted medical marijuana laws. In their conclusions, the researchers suggested that medical marijuana should be part of policy aimed to prevent opioid overdose.

Outside marijuana’s harms and benefits, missing in this discussion is the social environment of drug use. Drug use is social in nature. Where and with whom drugs are used influences why and how they are used. Socially acceptable or moderate use of drugs can be learned through social rituals in socially controlled settings.

Studies in the Netherlands found that using marijuana in Amsterdam coffeehouses encouraged a “stepping-off” hard drug use. These studies also found that when young people used marijuana in a controlled coffeehouse setting instead of a polydrug-using environment, they learned to use marijuana moderately without combining with other drugs. Along with providing access to marijuana, it’s important to instruct users on safe and effective medical marijuana consumption.

Since Massachusetts has not yet opened its medical marijuana dispensaries, it is too early to see if medical marijuana legislation will help reduce opiate addiction in the Commonwealth. Using recent research findings, Massachusetts policymakers have a unique opportunity to implement medical marijuana policies that address its contemporary opiate overdose. Medical marijuana could be part of drug treatment for heroin and opiates.

For homeless people, however, getting a marijuana card is expensive and buying medical marijuana from a dispensary is beyond their economic means. Street drugs are more prevalent in their social setting, easier to obtain, and can be much cheaper. From a policy perspective, addressing the alarming rates of overdose deaths among the homeless in Boston could mean distributing medical marijuana cards to homeless addicts for free and providing reduced cost medical marijuana.

Formerly demonized and later legislated as a Schedule 1 substance, marijuana could diminish the damage wrought by harder drugs, like heroin. While opioid use is a nationwide epidemic, Massachusettes – long at the forefront of developing scientifically based public policy – has the opportunity to be at the forefront of cutting-edge, socially-informed drug policy.

This is the second in a series of three articles on alternative strategies to treat addiction. To read the first in the series, click here.

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By Andrew Beattie

The discovery of a new antibiotic called teixobactin was announced by international team of researchers, in January this year. It is the most significant new antibiotic to be discovered in more than 30 years, and it may help combat the growing number of drug-resistant bacteria.

However, there are two reasons why the discovery of this “game-changing” antibiotic is far more significant than the media has generally portrayed.

The first is because it was isolated from a bacterium that was previously unculturable. Bacterial chemistry and metabolism is so diverse, flexible and complex that their vital growth factors are often totally unknown. So, until now, it has been impossible to grow colonies of most of them in the lab for experimentation.

The startling situation is that microbiologists tell us that most bacteria – an estimated 99% – are currently regarded as unculturable. Thus this discovery opens the door, even if only a chink, to a vast new untapped resource for medicine, especially new antibiotics.

If one previously unknown bacterial species has yielded a new and spectacular hope in the fight against disease, then what awaits discovery among the many millions of the others?

Hot chip

Let’s backtrack and briefly explore the technological breakthrough involved. The first is the astonishing fact that the resource was one gram of dirt from a grassy field in the state of Maine in the United States. The geography is probably irrelevant, though, as any handful of soil contains thousands of different kinds of bacteria and billions of individual bacterial cells.

The novel technology involved is known as the iChip, and it is simple in concept. Since we do not know what chemicals to add to our laboratory substrates in order to culture most bacteria, why not somehow keep them in their native soil and grow them there?

This is enabled by the iChip, which is a small grid of tiny compartments, each sheathed with permeable membrane and each occupied by a single bacterial cell.

These cells have been diluted out from a soil sample and manoeuvred so that there is one per compartment. The iChip is then placed back into the soil where the sample originated and where their unknown growth factors are evidently present. The cells multiply into cultures of a size sufficient to obtain their secretions, including any antibiotics.

The surprise was not only that the researchers were able to obtain useful antibiotic secretions – in this case from a new species called Eleftheria terrae – but many of the new bacteria had uncertain relationships to any others.

Lab trials showed the new antibiotic killed 100% of highly resistant golden staph strains. It did this by destroying two different structural targets in the bacterial cell wall, a detail likely to make it very hard to evolve resistance. Teixobactin is now in preclinical trials.

Gold in the ground

Now we should backtrack even further. Antibiotics were largely developed by culturing soil microbes and extracting natural products from them. This approach came to be regarded as old-fashioned following massive investment into new synthetic methods by the pharmaceutical companies.

Unfortunately, though greatly hyped, synthetic methods have disappointed. The industry is now once again looking for natural products. A critical reason for this change in direction is that bacterial pathogens are evolving resistance not just to single antibiotics but to groups of them that are sufficiently similar in structure that resistance to one leads to resistance to many, a phenomenon called “cross-resistance”.

The industry seeks novelty. This, it turns out, is already a feature of natural products. This is not to say that synthetic methods are dead. In fact, they are more likely these days to use a natural product as the starting point for further research.

Thus the second real significance of the discovery is the return to natural products as a basic resource for industrial innovation. Perhaps surprisingly, this places the academic discipline of evolutionary ecology at its cutting edge.

A better worked example illustrates this. When molecular biologists were looking for enzymes that remained stable when heated, they asked the evolutionary question: have these enzymes already evolved naturally?

Logic led them to the bacteria of hot springs, where they found an enzyme that revolutionised medicine and the biological industries, Taq polymerase in the bacterium Thermus aquaticus.

The bacteria have been on this planet for billions of years. While we do not know how long Eleftheria terrae has been around, its product, teixobactin, has evolved over untold generations. Its various precursors have been tried and tested by the rigours of natural selection. All free of charge.

The teixobactin discovery, together with the exploding levels of research into the bacteria of the human body and the soil, mean that at long last we are waking up to the true potential of microbial biodiversity, which is the greatest part of all biodiversity.

Thus, despite all the doom and gloom surrounding superbugs and the dearth of new antibiotics, there is now more cause for optimism. This can even be seen in the pages of the world’s top science journals as microbiologists urge a return to microbial biodiversity as a primary resource for new medicines and in Rockefeller University’s citizen science project, Drugs from Dirt, which aims to source soil samples from across the world for drug discovery.

Thanks to soil bacteria, we might have a way to fight back after all.

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By Elena Conis, Emory University

The news on the current measles outbreak contains plenty of reminders that measles causes brain damage, pneumonia, hearing loss and death. A few lone voices have spoken up to say measles isn’t that serious, including an Arizona doctor who said it’s “really just a fever and a rash” – and soon found himself under investigation by his state’s medical board.

Back in the 1960s, it wasn’t controversial to call measles benign. Though the disease killed about 400-500 Americans a year, it was considered a normal part of childhood. It was so common, in fact, that to this day, people born in the pre-measles vaccine era are considered immune. But the introduction of the measles vaccine, and efforts to promote it, fundamentally changed things. In the five decades since we’ve been immunizing against it, measles has become increasingly known as a deadly killer.

This transformation in perception, from relatively benign to a serious disease, isn’t unique to measles. As I have discovered in my research, it’s a pattern that’s been repeated over and over again in the modern history of immunization. This is not to say that measles is now considered a mild infection, or to suggest that risk from the virus, or other vaccine-preventable diseases, is overestimated. The point I want to argue is that the introduction of a vaccine reframes our perception of the disease it prevents.

Vaccines change our perception of risk

How does this happen? New vaccines simultaneously drive down the number of people getting the disease and increase our awareness of the risks of the disease.

Vaccines shine a spotlight on their target infections and, in time, those infections — no matter how “common” or relatively unimportant they may have seemed before — become known for their rare and serious complications and defined by the urgency of their prevention.

This certainly happened to measles, whose first vaccine was uneventfully released in 1963.

At the time, many parents saw measles as a common and relatively harmless part of childhood – even though it infected three to four million people a year and caused roughly 48,000 hospitalizations annually. Many doctors felt as parents did, especially when comparing measles to such worrisome disease threats as smallpox and polio. Even the head of the Centers for Disease Control described measles as a disease “of only mild severity” which caused “infrequent complications.”

But the very development of the vaccine focused new scientific attention on the disease. Within a few years, scientists had compared measles to polio — the previous decade’s public health priority — and found it a much more serious threat to children’s health. Inspired by this finding, and frustrated by the public’s lack of enthusiasm for the vaccine, federal health officials launched a national campaign to publicize measles’ dangers.

The campaign officially spread the word, for the first time, that measles was “a serious disease that sometimes causes pneumonia, deafness, encephalitis and even death.” Public figures ranging from the Surgeon General to Ann Landers announced that measles could leave children blind, deaf and mentally impaired. And the campaign employed a poster child — disabled ten-year-old Kim Fisher — to illustrate the idea that measles immunization was necessary because “one death, one brain-damaged child, or even one child who needs hospitalization is one too many,” as one campaign supporter put it.

A new picture of measles emerges

As the campaign wore on, scientists continued to study the disease more closely than ever. Doctors began to report measles cases to health departments at unprecedented rates. And together, doctors and scientists began to pay more attention to the disease’s risks than even before. As a result, a new picture of the disease began to form: it appeared to cause more deaths than previously thought, brain damage in even mild cases, even harm to fetuses.

As the public continued to respond to the national campaign with “general apathy,” however, health officials redoubled their efforts to publicize measles’ “dramatic aspects,” and states began passing laws requiring the vaccine for schoolchildren. Within just over a decade, the country saw an all-time low of measles cases — and the disease had solidly acquired its new reputation as a deadly infection worthy of prevention at any cost.

We used to think mumps and chickenpox were ‘mild’ too

In the decades that followed the introduction of the measles vaccine, vaccine makers and health officials duplicated this approach with one new vaccine after another.

Mumps, often the butt of jokes in its pre-vaccine days, was no laughing matter within a decade of its vaccine’s introduction in 1967. Hepatitis B was considered an obscure infection of little import to most Americans when its vaccine first came out in 1981, but soon after it evolved into a “cousin” of AIDS known for lurking in nail salons, piercing parlors and playgrounds.

Since the development of the chickenpox vaccine in the 1990s, the virus has been transformed in the public imagination from an innocuous if uncomfortable rite of childhood to a highly contagious infection that can cause pneumonia, sepsis and sometimes death. And in just the last decade, human papillomavirus (HPV) has morphed from a little-known sexually transmitted infection to a widely known cause of multiple forms of cancer. Each of these transformations in perception was triggered by a new vaccine.

Each new vaccine invited deliberation on how it should be used. That, in turn, focused increased scientific attention on the disease. Often, as federal health officials and other scientists accumulated new information about the disease’s risks and complications, the vaccine maker did its part to market its vaccine. As talk of each disease and its more dramatic aspects spread, public and scientific perception of the disease gradually transformed.

In this country, high vaccination rates rest on a consensus about the diseases prevented by vaccines. When doctors, health officials and, in particular, parents view a disease as serious, they view its vaccine as one worth getting.

The recent increase in the number of philosophical objectors to measles vaccine shows that historical consensus about the disease itself has eroded in recent years. But history also shows that one surefire route to consensus about a disease is fear of that disease. And fear often spreads like wildfire during disease outbreaks, much like what is happening once again now with measles.

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