By Sara Calabro
The FDA last week approved the first new drug for lupus in over 50 years.
This is potentially great news for lupus patients, who have not seen an effective treatment advance since steroids and an antimalarial drug were cleared for the disease in 1955.
However, the time it took to get even this far—the new drug, Benlysta, has many imperfections—highlights the inherent challenge of treating chronic, systemic diseases within the biomedical paradigm.
Two distinct perspectives on chronic disease
Mainstream medicine is not set up to think about the interconnectedness of symptoms.
A patient complaining of joint pain, chest pain and abdominal pain—all symptoms of lupus—is sent by her primary care doctor to see a rheumatologist, cardiologist and gastroenterologist. Each symptom is viewed in isolation to accomodate one-size-fits-all interventions.
While appropriate and life-saving in emergencies, this approach is problematic for chronic conditions because they involve several parts of the body and manifest differently from patient to patient. This is why biomedicine frequently falls short when it comes to things like pain management, irritable bowel syndrome, and chronic fatigue syndrome.
In contrast, acupuncture looks at the interdependent relationships of all the body’s structures and functions, and how they are affected by emotional and environmental factors.
An acupuncture perspective on disease is especially well suited for conditions, like lupus, whose symptoms can easily (and frequently do) lead to misdiagnoses. One person’s joint, chest and abdominal pain are not the same as the next’s.
Acupuncture addresses the underlying cause of symptoms rather than the symptoms themselves, which allows for individualized treatments that simultaneously address multiple systems throughout the body.
56 years and still a long way to go
Lupus is a complicated autoimmune condition for which PubMed lists the following symptoms: joint pain, chest pain, fatigue, fever, general discomfort, uneasiness, malaise, hair loss, mouth sores, sensitivity to sunlight, skin rashes and discoloration, swollen lymph nodes, headaches, mild cognitive impairment, numbness or pain in the arms or legs, personality change, psychosis, seizures, vision problems, abdominal pain, nausea, vomiting, heart arrhythmias, blood in the urine, coughing up blood, difficulty breathing, and Raynaud’s phenomenon (discoloration of fingers and toes).
No wonder it’s taken 56 years to develop a drug that’s mildly effective.
The FDA estimates that about one in 11 patients will benefit from Benlysta. That’s not horrible, but since the drug costs $35,000 a year, likelihood of success is an important consideration.
Another issue is that the clinical trials only looked at Benlysta in combination with standard lupus therapy (corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatories). So the drug doesn’t appear to eliminate any of the side effects that lupus patients have been battling for decades. If anything, it adds some—nausea, diarrhea, fever, and infusion reactions were seen in study participants.
Finally, African Americans, who have higher rates of lupus than whites, didn’t respond to Benlysta. The FDA said there were too few African Americans in the initial studies to draw a definitive conclusion, so the drug’s developer has agreed to conduct an additional trial that focuses on this population.
Even more than a new drug, we need a new mindset
The point is not to tear down Benlysta—at minimum, the approval will probably incentivize other pharma companies to invest in lupus, which could ultimately lead to the disease being better understood. But the drug’s shortcomings help demonstrate the need for individualized, whole-body perspectives to play a more prominent role in mainstream medicine.
Our healthcare system’s near-exclusive reliance on the biomedical approach has made it extremely challenging for lupus patients (and those suffering from other chronic conditions) to move beyond mediocre symptom management.
By opening to the idea that therapies like acupuncture—premised on the interconnected nature of disease and intended to address the underlying imbalances that cause symptoms in the first place—have something to teach us, we’ll move exponentially closer to solving complicated puzzles like lupus.
At a time when biomedical R&D has withered to focus primarily on profit makers, the approval of therapies that are truly innovative is cause for celebration. But an even bigger leap forward may be a change in mindset.
Photo by Sara Calabro
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