Pain isn't always a slow burn. Sometimes, it’s a lightning strike.
For many people living with cancer, the most terrifying part of the day isn't the scheduled chemotherapy or the mounting medical bills. It is the sudden, jagged spike of agony that rips through even the strongest medication.
Clinicians call this Breakthrough Cancer Pain (BTcP). Dr. Sud Agarwal, a specialist anesthesiologist and CEO of iNGENū CRO, calls it something else: a silent crisis.
Honestly, we don't talk about it enough. We focus on the tumor, the "cure," and the long-term survival rates. But for the person sitting in a living room at 3:00 AM, unable to breathe because the pain has bypassed their 24-hour patches, those survival stats don't mean much. They need relief, and they need it in minutes, not hours.
What is Sud Agarwal's "Silent Crisis" Exactly?
Most cancer patients are on a "background" regimen. This is usually a slow-release opioid or similar analgesic designed to keep pain at a manageable level throughout the day. It’s like a thermostat keeping a room at a steady temperature.
Breakthrough pain is the window shattering in the middle of a blizzard.
It hits fast. It peaks in under ten minutes. Usually, it’s gone within an hour, but it leaves the patient exhausted and traumatized. Dr. Agarwal has highlighted that this isn't just "extra pain"—it’s a distinct clinical event that requires its own specific treatment strategy.
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The 2024 Market Vacuum
The reason this has become a full-blown crisis recently is largely due to a massive shift in the drug market.
In late 2024, manufacturers essentially walked away from transmucosal immediate-release fentanyl (TIRF) products in the U.S. These were the nasal sprays, the lozenges, and the sublingual tablets that worked fast enough to catch a breakthrough episode.
Why did they leave? Regulatory pressure. Fear of the "opioid crisis" narrative. Legal risks.
The result? A huge gap. Doctors are now forced to use oral pills that take 40 to 60 minutes to kick in. By the time the medicine works, the breakthrough episode has often already passed. That’s not medicine; that’s a tragedy of timing.
Why We Keep Getting the Data Wrong
You’ve probably heard that "AI is changing everything," and yeah, it’s a bit of a cliché. But Sud Agarwal argues that in the world of clinical trials, we’ve been measuring the wrong things for decades.
Traditional trials use "pain scales." On a scale of 1 to 10, how do you feel?
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That’s fine for a broken leg. It sucks for breakthrough pain.
If a researcher asks you how you feel at 2:00 PM, and your last "lightning strike" was at 10:00 AM, you might say "3 out of 10." The data looks great. The drug looks like a success. But that data misses the sheer terror of the 10/10 spike that happened four hours ago.
Agarwal is pushing for adaptive trial designs. He wants to see more:
- Wearable tech that tracks heart rate spikes during pain episodes.
- e-Diaries that capture the "onset-to-peak" duration in real-time.
- Decentralized trials where patients are monitored in their own homes, not in a sterile clinic where they might feel "fine" for the hour they are there.
The Stigma of "Speed" in Medication
There’s a weird tension in oncology right now. We want drugs to be effective, but we are terrified of drugs that work too fast.
Fast-acting drugs, particularly opioids, carry a high risk of misuse. That’s a real, valid concern. However, for a terminal cancer patient, the risk of "misuse" often pales in comparison to the certainty of excruciating suffering.
Dr. Agarwal’s work often touches on this "de-risking" balance. How do we create delivery systems—like the newer cannabinoid-based inhalers or novel rapid-onset formulations—that provide the speed of a fentanyl spray without the same baggage?
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It’s about precision. If we can target the "silent crisis" with the same intensity we use to target the tumor itself, the quality of life for millions would shift overnight.
Nuance and Limitations: It’s Not a Simple Fix
Look, it would be easy to say "just give patients better drugs." But it’s never that simple.
Some patients have "incident pain," which is triggered by movement. Others have "spontaneous pain" that comes out of nowhere. One drug won't fit both. Furthermore, the healthcare system is slow. Even if a company like iNGENū helps a biotech firm bring a new drug to market 90% faster—something Agarwal is actively trying to do through automation—the insurance companies and hospital boards still have to approve it.
We also have to be honest about the limitations of "digital health." A smartphone app doesn't take away the pain; it only records it. We need the recorded data to actually influence the next generation of drug development, otherwise, it’s just more noise in a crowded field.
How to Manage the Crisis (For Patients and Families)
If you or a loved one are dealing with these "lightning strikes" of pain, you don't have to just "tough it out." Here is what the current landscape suggests:
- Track the Spikes, Not the Average: Keep a log of exactly how long it takes for a pain flare to reach its worst point. This data is gold for your palliative care team.
- Ask About "Off-Label" Options: Since the withdrawal of many TIRF products, some doctors are looking at alternative delivery methods. Don't be afraid to ask, "Is there something that works faster than a swallowed pill?"
- Advocate for Palliative Care Early: Palliative care isn't hospice. It’s specialized care for symptom management. The earlier they are involved, the better your "background" meds will be.
- Look into Clinical Trials: Companies are currently testing non-opioid fast-acting treatments. Websites like ClinicalTrials.gov or platforms managed by specialist CROs can show what's in the pipeline.
The "silent crisis" is only silent because the people suffering from it are often too exhausted to shout. By shifting the focus from "survival at all costs" to "comfort at all moments," we can start to bridge the gap that Sud Agarwal and other researchers are highlighting.
Pain management shouldn't be a secondary thought in cancer care; it should be the foundation.
Actionable Insight: If you’re a caregiver, start a "Pain Velocity Log" today. Instead of just recording "high" or "low" pain, record how many minutes it takes to go from 0 to 10. Bring this specific metric to your next oncology appointment to demand a more responsive treatment plan.