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Protect At All Costs

Humira, the world’s bestselling drug, has turned AbbVie into a global powerhouse. The company has proved to be great at guarding its patents—and not so great at developing new therapies. How a blockbuster medication became a case study in what’s killing drug innovation.

SY Mukherjee
YOU MAY NOT HAVE any of the conditions Humira treats. But chances are, you’ve heard of it.

AbbVie’s flagship therapy, a medicine used to treat a slew of conditions from arthritis to psoriasis to Crohn’s disease and ulcerative colitis, is the bestselling drug in the world, bringing in nearly $20 billion in global sales last year alone. As one U.S. senator noted at a hearing on drug prices in February, that titanic sales figure would be enough to put Humira (were it a company unto itself) on the Fortune 500 list.

And on first glance, it’s hard to conceive of a more perfect archetype for drug success. Abbott Laboratories—which spun off its branded pharmaceuticals unit as a separate company, AbbVie, in 2013—received its first FDA approval to market the medicine on Dec. 31, 2002. A little more than two years later, the injectable drug surpassed the billion-dollar mark in global sales, traditionally the threshold for “blockbuster” status in the pharmaceutical industry—a stunning feat in such a brief span. By 2006, sales had reached $2 billion, a number that would more than double in just two years’ time. By 2013, Humira was the world’s bestselling drug, with $10.7 billion in sales across more than 60 markets, and as improbable as it seems, even that colossal sales figure has nearly doubled again in the half-decade since.

Humira is also, importantly, an effective medicine—and for some people, a life-changer. Injected under the skin by way of a prefilled syringe, the drug—technically, a human antibody (more on that detail soon)—works by inhibiting a key protein that’s central to inflammation, a process that’s implicated in a number of pathologies. In clinical trials, patients with rheumatoid arthritis, an autoimmune disease that leads to painful and progressive swelling of the joints, have experienced rapid improvement in movement and a marked slowing of joint deterioration. In the skin condition psoriasis, which afflicts more than 8 million Americans, studies found the drug could clear up painful and itchy rashes by 75% to 90% in months. In moderate-to-severe forms of Crohn’s disease, a gut disorder that can prove debilitating and require hospitalization or even surgery, the treatment has been able to cut the need for drastic medical action while boosting “mucosal healing”—a possible sign that an inflammatory bowel disease is in remission.

So, you might wonder, what’s not to like about a medicine that helps millions of people suffering from serious and painful conditions and that has made its owners billions of dollars in the process? Isn’t that what the pharmaceutical industry is supposed to do? The answer, like so many aspects of the drug industry, lies in the litany of side effects that are spelled out in the fine print. For the Humira tale has a dark side too—one that’s reflected in many billions of dollars in unnecessary drug costs for consumers and in stymied competition in a critical area of modern drug development. As much as it might look like the quintessential example of scientific innovation and marketing success, the story of how Humira became the world’s bestselling drug is a case study of an industry in slow-motion failure—of a corporate model that is increasingly forsaking investing in research and discovery in favor of purchasing it (at a premium) from the outside. That model is driving up costs for everybody—patients, government payers, insurers, and, yes, even drug company shareholders.

Indeed, read past those striking sales figures, and AbbVie’s $20 billion-a-year drug phenom might well look like a black-box warning for Big Pharma and consumers alike.

To understand why, it helps to understand what Humira is and where it came from.

HUMIRA ISN’T A “DRUG,” technically speaking—it’s a biological entity known as a monoclonal antibody, or mAb. Put simply, mAbs are proteins created by inducing a specific immune response; these lab-created antibodies then bind to specific antigens on the surface of biological adversaries and work to neutralize the offenders.

The FDA approved the first mAb, an immunosuppressive drug for organ transplant patients, in 1986. More than six dozen have been approved since then, with most targeting various cancers and immune diseases. But Humira was different in one key way from those that preceded it—it was a “fully human” antibody, as opposed to one derived from a mouse. Fully human mAbs are less likely to cause adverse side effects. Humira’s name is ​itself a tribute to this pioneering science—it stands for “human monoclonal antibody in rheumatoid arthritis,” the first disease it was approved to treat.

As cool as that science is, it didn’t come from AbbVie—or even from its progenitor, Abbott. Abbott picked up the biologic in 2001 when it purchased the Knoll Pharmaceutical unit from German chemical company BASF. Knoll, in turn, had licensed the antibody technology from a company called (appropriately) Cambridge Antibody Technology—which, in turn, had licensed it (in large part) from Britain’s Medical Research Council, where it was developed from the research of Sir Gregory Winter, who would eventually share in the 2018 Nobel Prize in Chemistry for that very same science.

It was Abbott, however, that received the first FDA approval for Humira, in 2002. Researchers there had the good sense to try it against other manifestations of inflammatory disease—and new clinical successes and approvals kept coming: In 2005, Abbott got permission to market the antibody for the treatment of psoriatic arthritis; then ankylosing spondylitis, a form of arthritis affecting the spine, in 2006; Crohn’s disease in 2007; plaque psoriasis (the most common type of the itchy skin condition) and a form of juvenile arthritis in 2008; and ulcerative colitis in 2012. After Abbott spun off AbbVie in 2013, the latter continued recruiting clinical trials in new disease settings and petitioning for regulatory approval across dozens of markets.

More indications mean a larger pool of patients to treat and, consequently, more sales—which is why drug companies do their best to increase the therapeutic reach of their drugs once they’ve gotten a single marketing approval from the FDA.

But in the case of Humira, its owners didn’t take any chances getting the word out. Last year alone, AbbVie spent just shy of $490 million to hawk its superstar product, topping the list of 2018 pharmaceutical ad spending, according to Kantar Media. By comparison, Pfizer’s $272 million on advertising for the pain drug Lyrica came in second. AbbVie also spent significantly on social media advertising, not included in the figure above. And television ads for Humira have aired more than 46,000 times since Jan. 1 of this year.

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August 2019