PHARMACOVIGILANCE FROM MASSACHUSETTS

 

When Amgen purchased a vacant parcel of land in the heart of Kendall Square in Cambridge, Mass. 25 years ago, the area was far from the thriving biotechnology hub it has since become. In 2001, Amgen, a biotechnology pioneer, completed construction of an eight-story, 297,000-square-foot facility on the site. Now one of the world’s leading independent biotechnology companies, Amgen has expanded its presence in Cambridge and today hosted members of the Massachusetts life sciences community and government officials at its newly renovated research and process development facility.

The event commemorated the completion of a renovation featuring next-generation laboratories and offices, a process development scale-up laboratory visible from the exterior and an interactive lobby highlighting Amgen’s science and patient stories. Amgen has invested approximately $100 million in the Cambridge facility since 2015, and more than 400 staff are based at the site.

“Amgen’s state-of-the-art facility here in Cambridge exemplifies what it means to be at the cutting edge of biomedical research,” said Robert A. Bradway, chairman and chief executive officer at Amgen. “Many of the ingredients you need to foster innovation are right here – talented people, the latest technology, and an environment conducive to advancing science. We chose Cambridge as one of our core research hubs because it is an environment with a thriving life sciences ecosystem that encourages innovation.”

The site accommodates research scientists with expertise in therapeutic discovery, specifically within medicinal chemistry, molecular engineering and discovery attribute sciences. Process development scientists and engineers support product commercialization and the advancement of manufacturing innovation.

Massachusetts is a global leader in technology, innovation, research and development because of the early investment and continued impact of companies like Amgen,” said Governor Charles Baker. “We welcome Amgen’s growth in Cambridge and the future healthcare advancements for patients around the world that will come of their updated state-of-the-art facility.”

Amgen’s neuroscience research group is based at the site, with efforts focused on migraine, analgesia, Alzheimer’s disease, and other chronic neurodegenerative diseases. Scientists within the neuroscience therapeutic area in Cambridge support Amgen’s migraine prevention clinical development program by investigating the cellular mechanism of action of the Calcitonin Gene-Related Peptide (CGRP) receptor, furthering the Company’s understanding in this area.

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.

“Amgen’s ongoing commitment to Cambridge further strengthens Massachusetts’ position as a global biosciences beacon,” said Senator Edward Markey. “From helping to cure Alzheimer’s to preventing migraine, the scientists and staff at Amgen will continue to discover and develop breakthroughs and medicines that will drive the life sciences for generations to come.”

The new process development scale-up laboratory provides a dedicated space for staff to test cutting-edge technologies focused on next-generation biomanufacturing. The company embarked on developing an open environment setting, designed for staff to share and communicate ideas easier, to enable more efficient decision-making and to foster greater collaboration amongst staff and the surrounding life sciences community. The lobby showcases interactive, visual elements to describe Amgen’s biology-first approach to understanding disease, and patient and research videos highlighting Amgen’s focus in cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation.

Since 2014, Amgen has entered into collaborations with LabCentral, Boston Children’s Hospital, Harvard Department of Molecular and Cellular Biology, as well as others.


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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