Consumers spend $2 billion on medical devices for pain, with the majority of the $60 billion pain management spending on medications. To address the opioid crisis, three years ago I quit practicing emergency medicine to adapt my needle pain relief devices for post-op pain. The perspective from inside the industry illuminates why there are so few device options on the market. If our society’s goal is health, we’re doing it wrong. And a new vampire movie is doing it right.
There are uncanny parallels between film and pharma. In the past decade, medium-sized successful niche films have been overshadowed by big blockbusters. With Southeast Asian revenue an increasing consideration, studios want films that translate well: superheroes and explosions are universal. Likewise, over past decades the regulatory landscape, physicians’ habits and our payor system now perpetuate pharma blockbusters, which are heavily driven by consumer marketing. Consider the similarities between this blood-sucking fiend film and our medical device landscape’s barriers to supporting consumers.
“Bite Me”is a vampire/IRS auditor romp sharing the humor sensibility of “What We Do in the Shadows”. Since the explosion-oriented distribution climate has shriveled indie film support, filmmaker Naomi MacDougall Jones decided to bypass mainstream and go straight for the audience. She’s taking Bite Me to independent cinemas, lawn screenings, bars – anywhere fans REQUEST a playing in their town. She’s trusting she’s making what people want and bypassing intermediaries.
The consumer medical device industry is fighting a similar uphill battle against the blockbuster pharma focus in the US. Once a blockbuster drug is approved, it costs pennies to make, insurance pays for it and patients are on the medication for years. This means profits are huge, and fund top notch scientists to do large expensive studies on the next iteration in the same mold. It’s hard to compete and raise awareness of effective alternatives – the US is one of only two countries where pharma can advertise directly to consumers. (Ironically the other is New Zealand, home of the other aforementioned vampire movie.)
To be approved, a drug like gabapentin for chronic pain only has to benefit 1 in 6 patients. In contrast, a pain relieving medical device has to go through the same costly safety testing and regulatory burden, but even if using it makes patients 250% more likely to have reduced pain, it’s not covered. For a healthcare industry whose goal is profit, distributing drugs makes a lot more sense than devices: patients only need one device, they expect devices to last forever, and the cost of making the devices never approaches pennies no matter how great the economies of scale. Because of this, many devices have to incorporate disposable parts (TENS pads) or jack prices through the roof (Willow Curve) to generate enough profit to get distributors interested and the public aware.
Unlike healthcare, entertainment naturally leverages social media for distribution. Genius singer Jonathan Coulton sets his shows when enough fans email to validate a concert date. But devices, particularly for pain, aren’t as fun to post on facebook. This of course begs the question, are consumers actually just more satisfied with medications for pain?
A 2011 Consumer Report interviewed 45000 people about what worked for pain. For almost all conditions, medications were second or third tier solutions. The AHRQ published a list of what worked for chronic pain in June of 2018. Physical solutions and practitioners using vibration, massage, and movement topped the list. So why aren’t there more options for home applications of these therapies?
- Physician training bias: the most common complaint that brings patients to physicians is pain. While we could recommend well-supported physical interventions, mindfulness, or magnesium supplements, our system prioritizes pills. We aren’t let into medical school unless we can parlez organic chemistry. Our superpower is writing prescriptions, so of course much time is devoted to pharmacology. But while physical problems usually require physical solutions, every aspect of how doctors learn echoes a pharma bias. We learn statistical analysis on drug studies; we learn side effects of drugs in dermatology; and when we’re post-call and hungry, we have drug rep sponsored lunches. There is no magnesium or orthotics lobby feeding students, and the economics of pills ensure the system’s perpetuation. We have conflated the practice of medicine to mean MEDICINES.
- Payors and CMS: while research supports the need for availability of multiple pain relief options, CMS has different efficacy criteria for approving devices. Payors could offer a stipend for those who try a device before gabapentin, or let pre-op patients trial devices, but … they don’t (weird, because devices are much cheaper). And because engineers may not be as able to write a good medical study or grant application, and device manufacturers don’t have the financial backing to support the studies, there are few physicians doing high quality medical device studies to prove value relative to drugs.
- There are a bunch of crap devices out there: because it’s inexpensive to connect a battery to some electrodes, there are a lot of devices that aren’t at the right frequencies to address pain, or intensity, or the devices make claims that they say only work if you use the device for weeks. Reviewers lack the sophistication to understand why one frequency works and another doesn’t, in part because the science of physical energy pain relief is still in journal articles, not textbooks. Lack of reimbursement also means lack of oversight, so there is a lot of snake oil. With a movie, you know if you like it. With devices, pain relief should be obvious too, but marketing has become more important than data since data doesn’t get devices covered.
A society that values variety and the freedom to try options for ourselves has to be vigilant, calling out monolithic systems that impede choice. The opioid crisis stems in large part from a regulatory and pharma bias that promotes pills over what people say works. Until people ask their doctors and pharmacies for a list of other options, there is little reason to change the system. You get more of what you subsidize - our payor system needs to look in the mirror. We will keep getting more and higher priced drugs, so long as that’s what payors support.
If YOU as a consumer want to support cool things that work by women-owned companies, helmed by women who have given TED talks , done crowd-funding, and who are trying to change a system, buy a VibraCool for pain, or reach out now and get Bite Me to come to a theater near you.