Moving Beyond the ‘Smiley Face’ Pain Scale: Could a More Scientific Pain Assessment Tool Save Lives?

Through the years, the “smiley face pain scale” embraced by a well-intentioned medical establishment in the 1980s has turned into a skull and cross bones.

Officially called the Wong-Baker FACES scale, it was developed so children could communicate how much pain they are in while in the hospital. Ranging from a crying face to a happy face, patients simply circle the face corresponding with how they feel after a surgical procedure. Or sometimes, patients are given the scale before surgery and asked to circle the face corresponding with how they would like to feel after the operation.

But pain is subjective. And how many people when asked before surgery would circle the crying face?

Now, a biomedical startup called Proove Biosciences says its products will more accurately and scientifically assess a person’s pain tolerance and susceptibility to opioid addiction. By simply swabbing a patient’s cheek with a stick, Proove can perform 12 genetic assessments that will determine risk of opioid addiction.

The tests look at genetic influence of receptors for serotonin 2A, serotonin transporter, catechol-0-methyl transferase, dopamine 02 receptor, dopamine 01 receptor, dopamine transporter, dopamine beta hydroxylase, methylene tetrahydrofolate reductase, kappa opioid receptor, gamma-aminobutyric acid and mu opioid receptor.

Dopamine and serotonin control mood and pleasure within the brain, and the receptors that activate them are genetically influenced. The same goes for opioid receptors, which activates dopamine and serotonin

Proove CEO: A ‘Herculean’ Task at Hand

“When we began this journey in 2009, we had a simple – albeit Herculean – goal to alleviate suffering from opioid addiction and pain,” Proove CEO Brian Meshkin said in news release.1 “Particularly at a time when opioid addiction and overdose has taken center stage in America, we are passionate about and committed to finding solutions to improve outcomes for pain prescribers, patients and insurers alike.”

Meshkin told CNBC in September that Proove so far has sold about 30,000 tests to 300 doctors.2 CNBC also reported that most insurance companies will pay for the $1,000 test and that Proove “is working toward FDA clearance on the various tests it offers.”

On its website, Proove claims 93 percent accuracy in predicting opioid abuse.3 For doctors who don’t use Proove, they have a 50-50 chance of determining whether a patient will abuse painkillers or not, Proove argues.

Proove also sells tests to predict pain perception and responses to other pain relievers, such as NSAIDS, and even reactions to epidurals with fentanyl. They also have a test to predict best treatments for patients with fibromyalgia.

Dr. Richard Friedman, a psychiatrist at Weill Cornell Medical School, told The Daily Beast that Proove’s claim of 93 percent accuracy in predicting opioid addiction “cannot be taken seriously by scientists, clinicians and, most importantly, the public” until such findings are published in a peer-reviewed medical journal.4

Study in Pain Physician Makes Argument for Proove

Peer-reviewed medical research does exist that makes the argument for a product that does what Proove’s claims. Proove is even used as the primary example in the research.

“Differences in the degree of pain stimulation and pain sensitivity, weight and age differences, prior opioid use and tolerance, as well as the differences in bioavailability of various opioid formulations have been cited as causes for the wide variability of responses (to pain medication) and help to predict more effective (or less dangerous) medication choices and doses,” authors Drs. Andrea M. Trescot and Semyon Faynboym argue in the journal Pain Physician.5
Genetic Contribution to Pain Chart: Low Back Pain (21% to 67%), Migraines (39% to 58%), and Menstrual Pain (55%)
They report that opioid dose requirements can vary by patient by “as much as 40-fold.” Anxiety and depression also can influence pain responses, per their paper. “Several (biological) twin studies (to separate nature and nurture) have looked at pain conditions, and concluded that migraines have a 39 to 58 percent genetic contribution, low back pain a 21 to 67 percent genetic contribution, and menstrual pain 55 percent.”

Other research shows that many people who suffer from pain and have co-occurring mental health disorders can find relief with proper mental health treatment and reduce or eliminate their need for opioid-based painkillers and other medications.6

At the time of the Pain Physician paper’s publication in 2014, Dr. Trescot worked as a pain management physician in Arkansas and Dr. Faynboym was a psychiatry resident at the Indiana University School of Medicine.

“Genetic testing may explain and predict many of the clinical responses seen with opioids and adjuvant medications, and may help the clinician identify those patients at genetic risk of opioid misuse and addiction,” they concluded.

More Research Needed to Back Proove’s Claims

The paper does call for more research to prove the efficacy of genetic testing. “Allele-based associations studies are expected to shed light on the medical mystery of why pain persists in some patients but not others, despite seemingly identical traumas,” the authors wrote. “In other words, why do some diabetic patients develop only numbness as the manifestation of their peripheral neuropathy while others with the same blood sugar fluctuations develop a painful peripheral neuropathy?”

Meshkin argues that Proove’s products can not only save lives by identifying people at particularly high risk for abusing opioids, but also save employers and the healthcare system money. “For employers dealing with the health insurance, workers compensation, disability and loss of productivity costs associated with chronic pains, job creators must look at innovations to reduce costs and improve outcomes,” Meshkin argues in a news release.7 “For over six years our team of scientists, clinicians, biostatisticians and academic collaborators have developed a patented technology platform to evaluate genetic, lifestyle and environmental data to avoid prescribing ineffective treatments, or worse outcomes like opioid addiction.”

In May, Proove’s laboratory received accreditation from the College of American Pathologists, the company announced in a news release.8

One thing is for certain: As the opioid epidemic sweeps the nation, it has emerged as one of the greatest public health hazards of all time.

One thing is for certain: As the opioid epidemic sweeps the nation, it has emerged as one of the greatest public health hazards of all time. This is not only because of overdose deaths, but also transmission of HIV (incurable) and Hepatitis C (curable with an $85,000 medication regimen) due to sharing needles. Something more scientific and less subjective than the “smiley face pain scale” is desperately needed.

“Integration of genetic analysis in clinical studies will increase the likelihood of identifying clinical and genetic factors that can be used to predict opioid responses,” the authors of the Pain Physician paper concluded. “With knowledge of a patient’s potential for beneficial response to a given opioid, a physician is armed with critical information that can guide therapeutic decisions. Incorporation of such biomarkers are emerging on the forefront of personalized medicine, and have the potential to dramatically improve the utility and efficacy of both current and future pain management strategies.”


Sources

1. Proove Biosciences (2016, July 21). Brian Meshkin Named Emerging Technology CEO Finalist for Orange County Technology Alliance Innovation Awards Founder of Leading Healthcare Decision-Making Company Recognized as Pioneer in Personalized Medicine. Marketwired. Retrieved Nov. 12, 2016, from http://www.marketwired.com/press-release/brian-meshkin-named-emerging-technology-ceo-finalist-orange-county-technology-alliance-2144481.htm
2. Pettitt, J. (2016, Sept. 7). The Genetic Test that can help fix America’s opioid painkiller addiction. CNBC. Retrieved Nov. 12, 2016, from http://www.cnbc.com/2016/09/07/the-genetic-test-that-can-help-fix-americas-opioid-painkiller-addiction.html
3. Proove. Proove Opioid Risk. Retrieved Nov. 12, 2016, from https://www.proove.com/proove-opioid-risk/
4. Siegel, Z. (2016, Oct. 16). Can a DNA Test Really Predict Opiate Addiction? The Daily Beast. Retrieved Nov. 12, 2016, from http://www.thedailybeast.com/articles/2016/10/16/can-a-dna-test-really-predict-opiate-addiction.html
5. Trescot, A. et al. (2014, 17: 425-445). A Review of the Role of Genetic Testing in Pain Medicine. Pain Physician. Retrieved Nov. 12, 2016, from http://www.painphysicianjournal.com/current/pdf?article=MjE2MQ%3D%3D&journal=84
6. Grossman, P. et al. (2004, 57: 34-43). Mindfulness-based Stress Reduction and health benefits: A Meta-Analysis. Journal of Psychosomatic Research. Retrieved Nov. 12, 2016, from http://s3.amazonaws.com/academia.edu.documents/30863901/MBSRMAJPR2004.pdf?AWSAccessKeyId=AKIAJ56TQJRTWSMTNPEA&Expires=1478946438&Signature=NyJ7Eem1iPtzBUGeAw4n1FImcZY%3D&response-content-disposition=inline%3B%20filename%3DMindfulness-based_stress_reduction_and_h.pdf
7. Proove Biosciences (2016, Sept. 29). Proove Biosciences Founder & CEO, Brian Meshkin, Set to Speak at Executive Next Practices Forum on Healthcare. Marketwired. Retrieved Nov. 12, 2016, from http://www.marketwired.com/press-release/proove-biosciences-founder-ceo-brian-meshkin-set-speak-executive-next-practices-2162732.htm
8. Proove Biosciences (2016, May 24) Proove Announces Lab Accreditation from the College of American Pathologists (CAP). Marketwired. Retrieved Nov. 12, 2016, from http://www.marketwired.com/press-release/proove-announces-lab-accreditation-from-the-college-of-american-pathologists-cap-2127995.htm

Written by David Heitz