The European Medicines Agency’s (EMA) 2016 annual report published today focuses on the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real life.

In 2016, the Agency recommended a marketing authorisation for 81 medicines for human use, including 27 new active substances. Many of these innovative substances build on the advances made in biomedical science and have the potential to make a difference for patients.



On the veterinary side, 11 medicines were recommended for approval, including six new active substances. A third of these medicines prevent viral or bacterial infections in food-producing animals.

Approximately half of the applicants who were granted a positive opinion for their medicine had received scientific advice from EMA during the development phase of their product. Scientific advice is EMA’s key tool to promote the collection of high-quality data on the benefits and risks of medicines.

As a result of the safety monitoring of all medicines marketed in the European Union (EU), the product information for over 300 medicines for human use was updated on the basis of new safety data. The revised information allows patients and healthcare professionals to make informed decisions based on the latest evidence when using or prescribing the medicine.

EMA’s annual report also highlights some of the Agency’s main projects, initiatives and achievements in 2016. These include the launch of PRIME (PRIority MEdicines), an initiative to support the development of medicines that address unmet medical needs and the policy on the publication of clinical trial data for new medicines, a groundbreaking new initiative that turned EMA into one of the most transparent medicines regulators worldwide. Other developments showcased in the report include new ways to collect data on medicines such as big data, patient registries and real world data, and EMA’s contribution to addressing public health challenges, including antimicrobial resistance and the Zika virus outbreak.



The report also contains three interviews with stakeholders and EMA representatives on topics of major interest in the area of medicines and health in 2016: 

  • vaccine hesitancy – a threat to public health;
  • creating an agile organisation for the 21st century;
  • how to reinforce surveillance of antimicrobial consumption.

The last part of the report provides a large amount of data and figures that illustrate the work of EMA and its impact.

Pharmacovigilance is the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Pharmacovigilance heavily focuses on adverse drug reactions, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose and misuse and abuse of a drug are also of interest.

More than 250 million prescriptions for painkillers are written each year in the United States. Enough were prescribed in 2010 to medicate each American adult every four hours for a month. Americans, about 5 percent of the world’s population, account for 99 percent of the world’s hydrocodone (Vicodin) consumption, 80 percent of the world’s oxycodone (Percocet and OxyContin) consumption and 65 percent of the world’s hydromorphone (Dilaudid) consumption. All the while the use of illicit drugs, including non-prescribed painkillers, continues to grow.

It’s no longer a secret that the substantial swath of Americans living under the influence of these opiates do so with at least the tacit approval of our political system. Our law enforcement agencies, after all, focus on only a small number of the poorest users (and then only the few who become addicted and engage in crime), and our taxpayer-funded healthcare programs support the epidemic by spending billions annually on these drugs. Moreover, government-sanctioned discussions of the problem typically revolve around addiction-related crime; the devastation the drug has brought to many small, rural communities; the spread of opioid use into the white middle class; or the easy transition to heroin use. Recent negotiations in Congress, touted for their bipartisan nature, are designed to make treatment and the anti-overdose drug Naloxone more available to addicts. There are also proposals to fund school-based educational programs and to limit the practice of “doctor shopping.” Analyses of the root causes of the epidemic as well as the inordinate profits of the pharmaceutical industry are typically left to reporters and filmmakers. But very little attention has addressed a most basic problem: Why are our elected officials not confronting this widespread drug dependence with the goal of limiting it, rather than trying to make addiction treatment more available?

Consider this analogy: Constipation caused by regular opioid use is now so common that there are medications marketed for opioid-induced constipation (OIC). That drug’s consumers are numerous enough to warrant an expensive Super Bowl commercial, one that depicts long-term opioid use as a given, and its amusingly chronic side effect as an easily treatable annoyance. According to the pharmaceutical industry, it’s the unfortunate consequence of long-term use that must be addressed. A second industry commercial mentions several specific side effects of OIC medications: a tear in the stomach or intestine and opioid withdrawal, for example. Another set of drugs designed to treat these symptoms is probably in the works, creating an expanding cycle of pills made to lessen the side effects of other pills, and so on. Though profitable for drug-makers, the pattern avoids the real problem while treating one set of symptoms after another.

This “symptom-response exchange” that occurs in the pharmaceutical industry intertwines with a similar symptom-response exchange taking place in the social world, where systemic problems are ignored while symptoms are addressed: A lack of jobs is responded to with medications; resulting crime elicits prison, which weakens families; broken families are responded to with welfare benefits, which breed dependence; and so on.

Perhaps the public furor elicited by the Buffalo case provides a hint of what would occur on a much wider and more active scale if fewer Americans were chemically numbed, or if their ready access to drugs were threatened, and if they instead confronted what they experience as painful lives. In tentative and understated ways, these otherwise silent Buffalonians pushed back on a system they had found nonresponsive. Previously mute, they found a voice. They demanded to be heard, and this time they were. In the end, they were not denied access to the painkillers that allowed them to get on with life and to be happy, even if for some it meant doing so in “zombie-like” fashion.

The personal assessments of hopelessness by the chronically poor and the former working class reflect what is often an objectively harsh reality, one that includes inferior education, lost jobs, low and stagnant wages, and little prospect of upward mobility. In a sense, the world they grew up in and anticipated living in has vanished. For the hollowed-out middle class, it’s frequently a life filled with the apprehension that accompanies continual change, and the fear of falling into the void that waits below. In this context, readily available and subsidized pain relievers offer an alluring promise of a more tolerable existence. It’s a promise that’s kept more reliably than are similar pledges offered every election cycle by mainstream politicians who are no longer believed.

Certainly, the benefits of widespread opioid use are understood by our elected leaders, especially in an era when respected pundits, viewing angry mobs, speak of a possible need to “restrain democracy.” It’s quite possible that during an era of gross inequality and low-paying, no-benefits jobs, a numbed electorate may be viewed favorably as an apathetic citizenry inclined to accept the status quo, even one that is traumatic, frightening, cruel, unfair, or lonely. It’s a status quo in which former sources of meaning are crippled or dead. Data on marriage and divorce rates, as well as those on non-marital childbearing and marital satisfaction levels, show that for the poor and working class, the family has effectively collapsed; jobs that provide a sense of dignity, control, and the wherewithal to provide for oneself and others, are gone; and religion’s capacity to nurture the spirit has broken down and a vibrant group life of neighborhoods has failed to replace it.

This reality has been ignored by those who helped create it. Only now, as darkness falls on a troubling presidential campaign, is the political class, suddenly worried about its own job security, conceding the devastation their policies have inflicted on so many. Unbalanced, international trade agreements and rampant outsourcing, the voiceless are finally told, might have been mistakes.

But what if they weren’t mistakes? What if these decisions were made with the knowledge that they would benefit the few and hurt the many? What if we have constructed a society in which there cannot be meaningful jobs for all who want them; a nation incapable of making all of its citizens literate; a place in which the sources of stability in families and neighborhoods cannot be resuscitated; one in which houses of worship and voluntary associations can no longer sustain a shared set of altruistic beliefs? What if, unwilling to provide the conditions necessary for contentment, our leaders are settling for a state of indifferent acceptance, one in which, rather than a reasonable income or usable skill set, they offer the disaffected a prescription?

Karl Marx wrote, “Religion is the sigh of the oppressed creature, the heart of a heartless world, and the soul of soulless conditions. It is the opium of the people.” By encouraging compliance and promising relief and contentment after death, religion convinces the exploited and the alienated to endure a burdensome existence. But Marx also believed that religion was a form of protest against those oppressive conditions, one that could become as real as the suffering itself. In this context, opiates may be fulfilling the political function once met by religion by keeping the masses quiet; but it could also be where the “revolution” begins: with the refusal of a small group in Buffalo to allow their comfortably numb lives to be threatened. When that distorted reality is interfered with, as one day it will likely be, the collapse of institutionalized widespread chemical pain relief could prove Marx right, sort of.

Religion’s grip on the lower classes has loosened considerably and may soon lack the ability to placate an expansive and increasingly diverse category of people. Soon, the truth in the metaphor underlying Marx’s observation may be reversed, with opiates becoming the religion of the masses, tied to shared beliefs, common rituals, and sacred objects. It may be the opioid epidemic that is the sigh of the oppressed creature, a lament for what has been lost, a distorted vision of a contented life worth rebelling for, a cry for change.

Marx believed that the premise of all criticism is the criticism of religion, that a critique of religion would lead to the critical assessment of other social institutions. In the United States today, an analysis of the opioid epidemic leads to an understanding of the profit-driven pharmaceutical industry, which in turn triggers a critique of the economy, and then of the political system that facilitates it, and so on.

Many of the Buffalo doctor’s supporters, for example, denounced those politicians who threatened easy access to painkillers, saying they were only trying to make a name for themselves and get votes. Others condemned the profit-hungry pharmaceutical industry for creating such widespread dependence in the first place. One comment cut to the core of the issue by asking what one was to do when life was defined by psychological or physical suffering: “If there is no cure for what a person has, should that person just curl up and suffer? Go from doctor to doctor trying to find some kind of mental relief—even a psychiatrist and therapist for months and years? Go from doctor to doctor for months and years looking for and praying for physical relief? Or just call it quits and find someway to end their life?”

In our secularized world, suffering and praying have lost their cachet; suicide has not, with rates increasing alarmingly among the white working class. For now, those who protest their diminished lives have limited themselves to rowdy displays of support for a man who promises to resurrect what has been lost. In Buffalo, confronted with the unwelcome prospect of viewing reality soberly, a group of people formed a small and angry congregation outside a closed pain management clinic.


The richest riskiest symbioses are playing out inside. The human body is home to 100 trillion microbes in mobile constellation. A mere 100 million stars, by comparison, make up the Milky Way. On our skin, encircling our orifices, throughout our guts and even within our cells, their genes outnumber ours by 500 to one. The changing census of these microbial presences, both tourists and residents, is our individualized microbiome. It is shaped by the food we eat, the company we keep, whether we were born vaginally or cut out of our mothers, fed from the breast or the bottle. A rough-and-ready measure of a healthy symbiosis is if our bacterial communities are not seen, smelt or felt. We ignore their mainly reliable, diligent and beneficial labor: they are our silent majority.

The presence of a defensive microbe can force a pathogen to become less virulent. Defensive microbes can also steal vital proteins from pathogens to make themselves stronger, causing the pathogens to evolve to produce fewer such proteins. This, in turn, makes the defensive microbes weaker – but enough damage has already been done to the pathogen to stifle its future growth and virulence.

Humans can start to risk considering microbes as allies. In Occident, infectious disease is no longer the leading cause of death. But to divide bacteria into two flavors, the baddies that make us sick and the goodies found in yogurt drinks, is to oversimplify an intriguing mess. Microbes don’t have static identities, and they don’t behave the same in different parts of our bodies. What’s untroubling in the gut can burn through the urinary tract or, if we’re unlucky, run riot in the blood. This is sepsis, and this can kill you.


We have all seen the ads: an earnest employee or parent who complains of fatigue but with the help of a specific drug is able to get back on the job or play catch with the kids in the backyard. These TV pharmaceutical advertisements, known as direct-to-consumer (DTC) ads, are ubiquitous—with drug makers spending $3 billion dollars a year on them in 2012. Yet they remain controversial among economists and other industry observers.

There’s a longstanding economics question about the effects of ads. Do they provide helpful information or just try to persuade people to buy a particular product.

Some argue that drugmakers use DTC ads mainly to steal business from rivals. This results in a costly arms race that guides consumers toward one of several negligibly differing, expensive branded drugs over equally effective generics. At the extreme, that line of argument supports banning DTC ads.

But other economists suggest DTC ads offer patients important information, boosting overall demand for classes of drugs that can genuinely help people, and ultimately serve a preventative role that benefits society as a whole. After all, some types of drugs, such as cholesterol-lowering statins, provide a broader societal benefit by preventing costly and life-threatening heart attacks.

To get at the true effects of these pharmaceutical ads, Starc took advantage of their displacement during the months preceding the 2008 presidential election, when campaign ads dominated people’s screens instead. Specifically, Starc examined how the absence of DTC ads impacted drug sales of four cholesterol-reducing statins.

The U.S. is unique in allowing DTC ads. New Zealand is the only other country that does. There are a lot of policy implications of this kind of advertising, so we were excited to do the research.

While the ads did cause some people to switch to a different brand-name drug, the overall benefit to society of encouraging consumers to try the drugs outweighs these costs. Given the health and financial benefit of taking a pill versus having a heart attack, she calculates that the benefit of the statin ads is enough to justify all spending on DTC ads.

We know statins reduce the number of heart attacks people have, and large numbers of people on statins are on government-funded Medicare, so if they have a heart attack, that’s very expensive for Medicare to cover. As taxpayers, we’d rather pay the $3 a day for a statin than the high cost of hospitalization for a heart attack.

If you think these ads increase demand for a cost-effective drug, then that’s a practice you don’t want to ban but to encourage. DTC ads for statins boost sales for more than just the single drug being advertised. Ads have positive effects when you consider the category as a whole. When you see a Crestor ad, you’re more likely to get Crestor, but you’re also more likely to potentially get one of the older drugs that’s off-patent, which we can see as positive spillover.

This informational effect of DTC ads, in the case of statins, promotes healthier choices by a larger group of consumers. That the advertising is getting more people to take statins is good from a social standpoint. In fact, the ads do significantly draw prescriptions away from competitors. The findings showed that revenue for branded advertised drugs would have been up to 24% higher in the absence of rival advertising. The “you advertise, so I have to advertise” mentality within the industry may result in more advertising than is truly needed.

Still, because of the overall benefits that statins provide, the value to society of direct-to-consumer advertising is positive on the whole. Meaning, even if companies are prompted to use DTC ads because of competition, the overall impact is good. In fact, banning DTC ads would lower sales of unadvertised drugs by about 4%.

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