Enbrel and the Autoimmune Era

How a banner biotech drug made in Chinese hamster ovary cells is changing disease even as it treats it. An Object Lesson.
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Enbrel is one of the top ten drugs in the U.S. by sales, garnering the pharmaceutical giants who co-market the drug, Amgen and Pfizer, billions of dollars in revenue annually. People take Enbrel for inflammatory conditions like rheumatoid arthritis and psoriasis, at prices of tens of thousands of dollars per year.

Enbrel is a biotech drug, or as the industry calls it, a "biologic." This means that Enbrel is made in living cell cultures rather than in a chemistry lab. It was one of the first successful products to emerge from the flourishing of innovations in cell biology since the 1990s.

We normally think of pharmaceutical manufacture as a chemical process, but biologic engineers are more like Dr. Frankenstein than like Walter White: biotech's beakers and vats hold living tissues instead of chemical compounds. Enbrel is a fusion protein, a molecule produced from recombinant DNA (rDNA)-a kind of molecular graft that combines multiple genetic properties like a horticultural graft joins vascular tissues. Biologic manufacture is thus also reminiscent of one of the most ancient forms of production: agriculture. Like the production of meat or vegetables, biologic manufacture requires the careful management of living, nonhuman things. In the case of Enbrel, genetically-modified Chinese hamster ovary cells churn out the desired proteins. Chinese hamster ovary cells are the go-to mammalian cell line for protein manufacture in the biotech industry, the biopharmaceutical equivalent of chicken.

While the public may not be used to thinking of pharmaceutical manufacture as a process akin to food engineering, they are nevertheless accustomed to ingesting pharmaceutical products like food. But from a consumer's perspective, drugs made from living matter are actually less like food than traditional chemical-based drugs are. Like biologics generally, Enbrel cannot be taken orally: your gut would kill it, so instead it must be injected below the skin.

Most biologics are administered in hospitals, but patients can get Enbrel at a pharmacy, store it in their refrigerators at home, and self-inject. Enbrel's first mode of packaging, available since 1998, is a kit with powder and solvent, which a patient (or a caregiver) mixes at home. This process brings the final step of pharmaceutical fabrication home: a carefully measured amount of sterile liquid is drawn from a vial into a syringe, injected into a vial of powder, mixed, and drawn back into the syringe. The resulting liquid is injected just below the skin. In so doing, the Enbrel patient participates in the creation and administration of the drug to a remarkable degree. When a consumer pops a tablet from a blister pack and swallows it whole, they don't have to think about what the tablet's components are, or how it is made. Indeed, it is difficult to see the tablet as components at all. In contrast, this Enbrel packaging enrolls the patient as compiler.

Obviously, people with moderate to severe rheumatoid arthritis may find this mixing and self-injection process particularly difficult. And so, a new form of packaging was released in 2004: an autoinjection pen.

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Types of Enbrel injector, from the manufacturer's website.

This delivery mode reduces the patient's participation in biotech production, and the self-inject pen is in that sense more like taking a pill. Yet since relatively few Enbrel patients have prior experience with self-injection - with the exception of those who have personal experience with, say, insulin-dependent diabetes, or with illicit intravenous drugs - for the overwhelming majority of patients, self-injection is still a new mode of intimacy with drugs.

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Compared to pills and even injections from a doctor or nurse, the process is unusual and unfamiliar. Enbrel's website offers a series of videos to help patients learn the process. In it, the science fiction futurism of Star Trek-style medical magic meets the humdrum reality of an ordinary den recliner. With the Enbrel pen, the futuristic and the ordinary are combined, like the drug itself is grafted from rDNA sequences.

Enbrel's most prominent spokesperson is pro golfer Phil Mickelson, and he is an appropriate icon not only for his wholesomeness and perseverance but also for his wealth. Enbrel's high price effectively limits its use to the first world, and so does its vulnerability to heat, since easy and reliable access to refrigeration is assumed. Even so, Enbrel still poses a challenge for the developed world's affluent, mobile lifestyle, since it can't simply be tossed in a bag or purse like a pill or an inhaler. Luckily, for patients on the go, EnbrelSupport™ offers a travel pack-including bubble wrap, a cooler packed with ice, and a thermometer-at no additional cost. Such are the perks of being a customer worth annual revenues in the five-figures.

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One of Pro Golfer Phil Mickelson's Enbrel endorsements (Enbrel.com)

It may be tempting to conclude that Enbrel is just a luxury drug, but it actually does improve quality of life for many people suffering from severe joint pain. Moreover, it provides a more general lesson about our contemporary experience of health and disease in the post-industrial economy. Until the twentieth century, infectious diseases were the most urgent ones, and the antibiotics that treated them were a major breakthrough in building the modern pharmaceutical industry. Antibiotics helped to cure many diseases that previously had been deadly, which allowed the industry to thrive even as it posed a risk to its future sustainability. Quick cures make for difficult business, because your customers no longer need your product.

After World War II, pharmaceutical development shifted from infectious diseases to chronic "degenerative diseases," especially heart disease. A slew of drugs became blockbusters, including those for high blood pressure and high cholesterol, by promising to reduce the risk of heart disease if you took them every day. In the late 20th century, the pharmaceutical industry extended its reach still further. "Life-style drugs"-pills that promise to enhance life rather than to save or lengthen it-became the dominant form of blockbuster. Think Prozac, think Viagra.

Both risk-reducing drugs and lifestyle drugs have a business advantage over antibiotics, because they are designed to be drugs for life, to be taken routinely by people who are expected to live long lives. There is a fundamental market limit for antibiotics: you stop taking them once you are cured. But for these risk-reducing and lifestyle drugs, a different economic pressure presents itself: generic competition. New blockbusters have yet to be developed to replace the late-twentieth century boom, and so almost all face generic competition.

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Anne Pollock is is an assistant professor of science, technology, and culture at Georgia Tech. She is the author of Medicating Race.

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