FDA Warns Against Pain Curing Claims Of CBD Industry

January 29, 2020 / Thomas Cohn, MD

cbd oil When it comes to selling healthcare products, companies often try to walk a fine line between marketing their product and making false claims about the true ability of their product. Oftentimes there are a lot of semantics at play and the Food and Drug Administration rarely intervenes over product claims unless they feel that the consumer is being grossly misled about a product. It appears they recently felt that way over claims made in the CBD industry.

We’ve talked about cannabidiol on the blog in the past, and like CBD, medical marijuana or other relatively new products on the healthcare market, our stance has been pretty similar. We want patients to find a solution that works for them, we want further scientific research to better understand these products, and we want patients to pair passive treatment options with active treatments like exercise and physical therapy. Until we can point to the science behind a product, we’re leery to suggest it as a solution other than to say, if it works for you and isn’t compromising your health, go for it.

CBD For Pain, Cancer and More

That’s not exactly the same sentiment felt by Rooted Apothecary LLC, a company based in Naples, Florida, that has been pushing CBD products on its customers. They are legally selling CBD products, but the FDA and the Federal Trade Commission believes the claims they are making about the effectiveness of the products are misleading and even illegal.

Some of the claims made by the company about their CBD products include such unsubstantiated claims as it can be effective for teething pain and earaches in infants, or that “CBD was effective in killing human breast cancer cells.” They also made claims that CBD has been effective in treating Parkinson’s disease, Alzheimer’s disease and can safely be used in conjunction with opioids. Not only are these claims unsubstantiated by science, but they can put the consumer’s health at risk.

“Cannabis and cannabis-derived compounds are subject to the same laws and
requirements as FDA-regulated products that contain any other substance,” said
Acting FDA Commissioner Ned Sharpless, MD, in a press release. “We’ve sent
numerous warning letters that focus on matters of significant public health
concern to CBD companies, and these actions should send a message to the
broader market about complying with FDA requirements. As we examine
potential regulatory pathways for the lawful marketing of cannabis products,
protecting and promoting public health through sound, science-based decision-
making remains our top priority.”

Whether it’s CBD or another health and wellness product, we recommend that you do your own research and consult with your physician if you have any questions, especially if you’re already trying certain treatments for your pain. If something sounds too good to be true, it probably is. CBD is far from snake oil, but it’s not a magic pill either. Do your research, trust your gut and consult a professional for any questions you have.

How Are Opioid Regulations Affecting Chronic Pain Patients?

October 21, 2019 / Thomas Cohn, MD

In the wake of increasing opioid overdoses across the country, lawmakers have called for much stricter regulations in how providers prescribe opioids to patients. The goal of the changes were to stop doctors from “taking the easy road” and prescribing opioids to patients because the doctor doesn’t want to take the time to dig into the problem and work towards a real solution. Lawmakers also undoubtedly thought that if fewer people have access to clinical opioids that overdoses would also decrease.

But how are these regulations actually affecting those individuals who are plagued with chronic pain? According to a new study, the changes aren’t exactly having the intended effect.

The Effects Of The Prescription Opioid Crackdown

According to a recent study published in the International Journal of Drug Policy, there have been a number of unintended and potentially harmful side effects associated with the recent prescription opioid crackdown. Researchers say that many patients on long-term opioid treatment for chronic pain reported experiencing the following in the wake of the crackdown:

Negative physical side effects
Emotional distress
Degraded relationships with their primary care provider

Although the study was relatively small in size (97 patients with chronic pain, mean age 61.3 years), the results were both interesting and alarming.

Negative physical side effects – According to the study, patients believed that their medications helped control their chronic pain, helped them sleep and provided them with the ability to think clearly without being bothered by daily pain. When they were tapered off their medications, they said their pain increased, and they had difficulty sleeping and concentrating.

Emotional distress – Many patients believed that stricter prescription opioid regulations would inhibit their access to vital pain medications and hinder their day-to-day well-being. Other patients responded that they went as far as to seek mental health counseling to deal with the stigma of being seen as an opioid user.

Degraded Relationship With Doctor – Finally, patients also reported that their relationship with their primary care physician worsened due to the new regulations. One patient felt angry with her physician for “enforcing a required opioid agreement” while another felt that he was being viewed by his doctor as a potential abuser as opposed to a patient.

“In addition to known side effects, patients also experience the burden of public discourse and associated institutional changes in opioid prescriptions as extremely stressful, placing a burden on their emotional health and relationships with their primary care providers,” noted the study authors. “ Chronic pain is a biopsychosocial phenomenon, requiring multi-faceted approaches and solutions.”

It takes a doctor who is willing to put in the time and effort with the patient, and a patient who is interested in active solutions to pain, in order to win the fight against chronic pain. Don’t get discouraged by recent regulations, just do what you can to find a specialist who takes your pain seriously and who won’t stop until you find relief. Dr. Cohn has done this for countless patients, and he can do it for you too. For more information, contact his office today.

Opioid Prescriptions Reach A 15-Year Low

August 29, 2018 / Thomas Cohn, MD

The number of opioid prescriptions in the United States has fallen dramatically, and prescriptions now sit at their lowest levels since 2003 according to new data from the Food and Drug Administration.

The data shows that 74 million metric tons of opioid analgesics were dispensed in the first six months of 2018, down more than 16 percent from the first six months in 2017. Although opioid prescriptions have been declining for the past couple years, the bigger decrease in 2018 is likely linked to lawmakers, doctors and patients working against the problem of opioid dependence.

“These trends seem to suggest that the policy efforts that we’ve taken are working as providers, payers and patients are collectively reducing some of their use of prescription opioid analgesic drugs,” said FDA commissioner Scott Gottlieb, MD.

Not All Good News

If we just look at the headline, it’s easy to infer that this is good news. Fewer patients relying on passive and potentially dangerous treatment options should be a good thing, but there are some drawbacks. For starters, the opioid crackdown is undoubtedly hurting a section of patients who use these medications properly and need them to control their discomfort. I’ve talked to patients who have found it harder to get the medications they rely on, and it’s troubling. Good people are getting caught up in the crackdown on opioids.

Perhaps more shocking is that despite the sharp drop in opioid prescriptions, opioid overdoses continue to rise. Although the data from 2018 wasn’t available, nearly 49,000 Americans died from opioid-related overdoses in 2017. This includes overdoses from fentanyl and heroin, which can be eventualities for individuals who become addicted to opioids.

“It isn’t necessarily the case that more people are suddenly switching from prescription opioids to these illicit drugs. The idea of people switching to illicit drugs isn’t new as an addiction expands, and some people have a harder time maintaining a supply of prescription drugs from doctors,” said Gottlieb. “What’s new is that more people are now switching to highly potent drugs that are far deadlier. That’s driven largely by the growing availability of the illicit fentanyls.”

Police data shows that a record amount of fentanyl (1,640 pounds) and heroin (5,500 pounds) have been seized by law enforcement this year, and we’re not even two-thirds the way through the calendar year.

Clearly we’re still losing the war on opioid overdoses, even if we hear headlines that suggest prescriptions are at a 15-year low. Chronic pain patients are caught in the crossfire, and overdose-related deaths continue to surge. We need to invest more money into understanding and treating chronic pain conditions in order to really make a difference.