By Martha Rosenberg
IT ISN’T YOUR IMAGINATION. More and more pharmaceutical drugs are expensive and meant to be injected, and that isn’t counting vaccines.
Biologic drugs, also called biologics, are produced from or with living organisms and are made up of blood components, cells, genes, and recombinant proteins such as those found in monoclonal antibodies.
Usually injected, these drugs typically cost about 22 times more than regular pharmaceutical drugs and “can generate profit margins of up to 40 percent,” according to Pharma’s Almanac, which explains the biologic drugmaker direction. In fact, in 2017, while only 2 percent of people in the United States had used biologic drugs, they accounted for 40 percent of prescription drug spending. Unlike regular pharmaceuticals, biologics can evade generic copies and can monopolize a market longer.
Last year, the global biologics market was estimated to be $366.43 billion. It’s projected to reach $ 719.84 billion by 2030, according to Precedence Research.
While biologics can target cancer and deliver chemotherapies, three of the 10 top-selling biologics
in 2021 — Humira, Enbrel, and Remicade — treat a cluster of immune-related conditions such as ankylosing spondylitis, rheumatoid arthritis, and plaque psoriasis, conditions that were less well-known before the years of heavy drugmaker advertising.
a month, making drugmakers more than $28 billion dollars in 2021 alone, with Humira pulling in the post at $20.7 billion and Enbrel and Remicade adding $4.36 billion and $3.2 billion, respectively.
Compare that to the $7.8 billion Pfizer made with its COVID-19 vaccine in 2021, and you see the profit bonanza.
But even as the biologics perform as blockbusters for their manufacturers, questions persist about their high prices, safety, efficacy, and marketing.
Drawbacks Of Immune Suppression
Humira, Enbrel, and Remicade are monoclonal antibodies called TNF suppressors; they work by suppressing the body’s “tumor necrosis factor,” which plays a role in autoimmune diseases and inflammation.
Genetically engineered in a lab like all monoclonal antibodies, the drugs are other- worldly chimeric mixtures of human and animal cells, a fact not found in their prescribing information or heard in their ubiquitous ads (although it’s conceded that Humira stands for “human monoclonal antibody in rheumatoid arthritis”).
Humira and Enbrel are made from genetically- modified Chinese hamster ovary cells, and Remicade is made from genetically engineered “humanized” mouse cells.
Because TNF suppressors weaken the immune system, they invite infections. According to Humira’s prescribing information, the biologic’s users are “at increased risk for developing serious infections that may lead to hospitalization or death. … Reported infections include: active tuberculosis (TB), including reactivation of latent TB … invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.”
And sure enough, the Milwaukee Journal Sentinel reported in 2019 that “Humira [has been] linked to 169,000 reported serious adverse events and 13,000 reports of deaths.”
There’s a marketing term, “disease mongering,” which refers to a drugmaker selling a disease in order to sell the drug manufactured to treat it.
Ads for rare conditions such as non-24-hour sleep-wake disorder and EPI, or exocrine pancreatic insufficiency, that “raise awareness” of an obscure condition and often include self-quizzes are clear examples of disease mongering, but ads for biologics may somewhat share the tactics.
“Growing patient knowledge of rheumatoid arthritis problems is another factor driving the global rheumatoid arthritis medications market,” Precedence Research wrote this year, noting that “the global rheumatoid arthritis drugs market size is estimated to surpass around US$70 billion by 2030.”
Certainly ankylosing spondylitis, rheumatoid arthritis, plaque psoriasis, and similar conditions exist and cause suffering, but marketers know that the seeking of treatment for diseases rises with drug advertising.
Ten years after direct-to-consumer drug advertising, which heavily sold antidepressants, research published in the Journal of Business Ethics in 2008 stated:
“This study finds that familiarity with direct-to-consumer (DTC) print advertisements for antidepressant brands is associated with inflated perceptions of the prevalence and lifetime risk of depression … The study ultimately demonstrates that DTC advertising may play a role in constructing social reality of diseases and medicine … as well as presenting issues regarding public health and the business ethics of advertising drugs to consumers.”
How did AbbVie turn an expensive, possibly dangerous drug into pay dirt? In 2003, its parent company, suburban-based Abbott Laboratories, announced that it would “provide its recently approved rheumatoid arthritis drug [Humira] free to Medicare patients without drug coverage until the government agrees to pay for the medicine,” according to the Chicago Tribune.
The maneuver worked, and the drug was covered by Medicare. Abbott then hired the public relations giant Edelman and the pharmaceutical ad agency Harrison and Star to blitz Humira and, in 2012, gave Humira to a newly spun-off company called AbbVie.
AbbVie took it from there. Between 2013 and 2017, AbbVie gave $2 million in grants and donations to the American Academy of Dermatology, which didn’t hurt sales. It launched a “nurse ambassador” program in 2012 in which registered nurses were paid to go to the homes of Humira patients, all the while downplaying the biologic’s risks of cancer and serious infections. The nurses were instructed to avoid directly answering patient questions about serious side effects, according to the Milwaukee Journal Sentinel.
California Insurance Commissioner Ricardo Lara’s office estimated that private insurers based in California alone likely “paid out $1.2 billion in Humira claims from 2013 to 2018, making it potentially the largest insurance fraud case in the department’s history,” the Journal Sentinel reported in 2019.
“Through the program, doctors allegedly got kickbacks in the form of cash, meals, drinks, gifts, trips, even patient referrals,” the newspaper wrote. “One court document indicates the national program reached 179,000 patients.”
What Do Patients Say?
Some patients swear by the TNF-suppressing biologics, which certainly explains their popularity — and profits.
On the website Ask a Patient, where patients rate prescription drugs, a 67-year-old woman who had been on Humira for nine years posted in 2017 about the drug: “Thankful every day for this amazing drug, which has given me back my life. Severe pain all over my body, from [the time I was] a fit and active 27-year-old, [I] became totally debilitated and most DMARDs [disease-modifying antirheumatic drugs] barely touched it. … No pain, no psoriasis. Happy person, back at work, and learned to SCUBA dive.”
Yet other patients on Ask a Patient cite staphylococcus and other serious infections, depression and mood side effects, sinus side effects, and the Humira ceasing to work after a while.
A 43-year-old man who took Humira for one year to treat spondylopathy wrote: “When I took Humira, it worked immediately. But within three months, I began to have worse sinus issues. Contracted klebsiella pneumonia and a systemic fungal infection and had to stop taking it. The fungal infection has been treatment resistant. I wish I knew then what I know now … that an anti-inflammatory diet works wonders for autoimmune disease. My arthritis is cleared from the diet, but I am disabled because of the infection caused by Humira. Stay away at all costs.”
Clearly, the profit potential of TNF-suppressor biologics has made them a drug of choice for many physicians and patients. However, concerns about pricing, risks, effectiveness, and marketing may raise skepticism — are the drugs good for patients or just good for drugmakers?
Many health-oriented websites offer natural treatments for the conditions that the TNF-suppressing biologics address. For many of these conditions, lifestyle, exercise, and dietary changes can have a profound effect. These approaches may help patients avoid a costly class of drugs and potential side effects.