Healthcare Is a Human Right That We Deserve

By Jennifer Kain Kilgore, PNN columnist

I shouldn’t have to write this. But here I am because of headlines like these:

“FTC Refunds Almost $3.9 Million to Purchasers of Deceptively Advertised Quell Wearable Pain-Relief Device”

My body went numb after reading that. The Quell, which I wore for four years, that I blogged about, that I recommended to friends and family? That Quell?

The Federal Trade Commission slapped parent company NeuroMetrix for deceptive advertising. Specifically, the company was cited for claiming the Quell works throughout the whole body and not just where it’s worn.

“NeuroMetrix settled the case – without admitting or denying the allegations – for $4 million. The company also agreed to stop claiming that Quell provides relief for chronic or severe pain beyond the knee area where the device is worn,” PNN reported.

Soon enough I was receiving texts -- “Is this true?” “Does it not work?”

It worked for me, but that’s not why I’m writing this. My testimonial is still and will remain on NeuroMetrix’s website. The company didn’t ask me to come to their defense. Despite the bad press, that gadget worked for me.

NEUROMETRIX IMAGE

Getting a $50 refund from NeuroMetrix in my PayPal account, though? The company’s silence and tacit admission made a helpless rage boil inside where anger has been simmering for weeks and months and years.

It made me as angry as when desperate pain patients called my law office, asking if I would draft legislation or talk sense to their doctors. Or when a genuinely good product came on the market but took advantage of customers. Or when the Sackler family didn’t go to prison after their pharmaceuticals created the conditions for the national opioid epidemic to truly explode. That bubbling anger began to rise.

Where should I direct this rage? At the callers? At the makers of the SpineGym, who took their crowdsourced money and failed to deliver on their promises? At the Sacklers? No, of course not. It’s not about them. My anger is bigger than that.

I shouldn’t have to write a reaction piece about the FTC’s decision. I shouldn’t have to draft laws to change a healthcare system in which pain patients are discounted, dismissed, and even overlooked.  Sometimes our limitations and physical pain prevent us from seeking the help we need.  

I shouldn’t have had to write for Pain News Network in the first place, though I’m thankful for the opportunity to do so. I became a columnist in order to try all the gadgets claiming to cure back and neck pain. If my doctors wouldn’t help me, I would help myself.

And there it is.

A record-breaking number of citizens have already voted. Despite their overwhelming voices, a Supreme Court justice was just appointed whose legal interpretation could dismantle the Affordable Care Act, which is on the Supreme Court Docket on November 10, just seven days after the most important election in history.

If you’re reading this, health insurance is crucially important to you or someone you love. Right now, our president’s legal team is in court attempting to kill the ACA without any kind of replacement during a global pandemic that has killed over 231,000 Americans.

But that’s not why I’m writing this.

I used to blog about my journey through the healthcare system. By the time I’d graduated from the Quell to an implanted spinal cord stimulator (which also works), I’d exhausted myself. It was time to focus on finally, finally healing. You know, being a normal person again.

The spinal cord stimulator -- controversial for sure, and not a surefire bet -- ended up working beyond my wildest dreams. Even though I’ve pulled on wires and scar tissue, my life has been partially restored. My doctor said the Quell was a good indicator as to whether a SCS would even work. If the Quell helped, so would a spinal cord stimulator.  

Before the SCS, I wasn’t able to consistently work as an attorney; I could barely leave my house. I was dependent on my husband for everything from insurance to carrying bags of groceries.

After the SCS, I can do yoga and pilates. I can lift laundry baskets. I can go to work and sit through a two-hour deposition. I can be an actual person again.

But that’s not why I’m writing this.

I shouldn’t have spent sixteen years of my life begging for help. I shouldn’t have to become a patient advocate and a writer for an online publication because I couldn’t otherwise afford pain-relief devices.

I shouldn’t have to write this.

I shouldn’t have to fight my insurance company to get my treatments covered. I shouldn’t have to stagger bill payments to various hospitals so as not to overdraft my account. I shouldn’t be paying for my spinal cord stimulator more than a year after its implantation.

I shouldn’t -- we shouldn’t -- have to do these things. We shouldn’t have to fight so hard to live in what’s supposedly the greatest country on earth.  What’s so great about living in fear? Fear of the unknown, the future, access to healthcare resources, and effective treatments? I’ve lived in fear for long enough, and so have you.

I shouldn’t be here. You shouldn’t be here, reading this. This website shouldn’t exist, and we shouldn’t have to fight so hard. But one in five Americans adults has chronic pain, and something must be done.

Healthcare is a human right, and we deserve it.  So VOTE.  Protect your loved ones by protecting healthcare.

Jennifer Kain Kilgore is an associate attorney at MALIS|LAW, working in civil litigation. She has chronic back and neck pain after two car accidents. 

Quell Customers to Receive $3.9 Million in Refunds

By Pat Anson, PNN Editor

The U.S. Federal Trade Commission is sending refunds of nearly $3.9 million to consumers who bought Quell, a wearable nerve stimulation device touted as a drug-free treatment for chronic pain. The refunds are part of a settlement the FTC reached in March with NeuroMetrix – the maker of Quell – over deceptive advertising.

An FTC complaint alleged that NeuroMetrix and CEO Shai Gozani advertised Quell as an effective treatment for fibromyalgia, osteoarthritis, sciatica, shingles and other chronic pain conditions without reliable scientific evidence to back it up.  

Two clinical studies cited in Quell advertisements had “substantial flaws,” according to the FTC, while a third study was based on a marketing survey conducted by the company to “generate potential advertising claims” about the device. The FTC also objected to claims that Quell was “clinically proven” and “FDA cleared” for chronic pain relief.

“Defendants engaged in their unlawful acts and practices repeatedly over a period of more than four years, continued their unlawful acts or practices despite knowledge of complaints that advertising claims for Quell were not substantiated and went beyond claims the FDA allowed for similar devices, and continued such deceptive advertising unabated until FTC staff notified them it would recommend law enforcement action,” the FTC complaint said.

Neurometrix settled the case – without admitting or denying the allegations – for $4 million. The company also agreed to stop claiming that Quell provides relief for chronic or severe pain beyond the knee area where the device is worn.

The FTC is using the settlement funds to send 2,144 refund checks and 67,998 refunds via PayPal to Quell purchasers. The average refund amount is $55.10 per customer. Consumers who do not receive a refund, but believe they should, should contact the refund administrator, Rust Consulting, at 1-866-403-6545.

The Quell device sells for $299, while an older version is available for $199. Quell is sold over-the-counter, does not require a prescription and is not usually covered by insurance.

NeuroMetrix recently announced that Quell will be used in a clinical trial on the use of transcutaneous electrical nerve stimulation (TENS) for chemotherapy-induced peripheral neuropathy  The study is being conducted at the University of Rochester School of Medicine and Dentistry, with funding from the National Institutes of Health. Quell is also being evaluated in a small study as a treatment for fibromyalgia.

FDA Wants More Medical Devices to Treat Pain

By Pat Anson, Editor

The deadline is fast approaching for companies to enter the Food and Drug Administration’s medical device challenge, a contest of sorts aimed at stimulating the development of new technologies to treat pain and prevent opioid abuse.

The FDA announced the innovation program in May and the deadline for applications is September 30.  Medical devices in any state of development – including those already on the market – are eligible for submission.

“Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids.”

Devices that are found to innovative will receive a “breakthrough device” designation from the FDA – similar to the “fast track” designation that the agency gives to promising pharmaceutical drugs. With fewer regulatory hurdles, companies can bring their products to the market sooner.

“I think its great. It’s exactly the kind of thing that’s needed,” said Shai Gozani, MD, President and CEO of NeuroMetrix, the maker of Quell. “It’s a little unclear what exactly they’ll offer to the winners. It looks like they’ll give you intensive help for a period of time to climb the regulatory pathway."

In recent years, the FDA has granted or approved over 200 devices related to the treatment and management of pain. One of them was Quell – a nerve stimulation device worn just below the knee – that relieves pain without drugs in patients suffering from arthritis, neuropathy, fibromyalgia and other chronic conditions. Since its release in 2015, over 150,000 Quell devices have been shipped.

This week NeuroMetrix released Quell 2.0 – an updated version that is half the size and weight. Customers wanted a smaller device to make it easier and more comfortable to wear throughout the day and while sleeping.

NEUROMETRIX IMAGE

“The feedback we got from customers over the past three years is that the single most valuable way to improve the product was to make it smaller,” said Gozani.  “Quell 2.0 is half the size, without any sacrifice in the electric stimulation characteristics. In fact, we increased the power by 20 percent, which allows us to stretch the range of patients that can be treated even further.”    

Gozani told PNN there is no single disorder or medical condition that Quell works best on -– it depends more on the individual, who may live with a variety of different conditions.

“Most people who use our product typically have five sites of pain and three or four medical conditions. It’s not like you can say that person has diabetes or that person has lower back pain or knee osteoarthritis. It all overlaps,” he said. “Surprisingly, we’ve seen that it works better in older adults than in younger.”

PNN columnist Jennifer Kilgore, who lives with chronic back pain, has used Quell every day for three years. She appears below in this promotional video for Quell.

A major difference between Quell 2.0 and the older “classic” Quell is that the new version is operated entirely by an app. It adjusts therapy automatically based on body position and doesn’t need to be turned on and off.

Quell is sold over-the-counter, does not require a prescription and is not usually covered by insurance. Quell 2.0 sells for $299, while the classic Quell is still available at $249. There’s a 60-day money back guarantee for both.

For more information, click here.

A Third of Pain Patients Have Stopped Using Rx Opioids

By Pat Anson, Editor

Over a third of pain patients (34%) have stopped taking opioid medications because their doctor is no longer willing to prescribe them, according to a large new survey of American adults living with chronic pain.

Eight out of ten patients (84%) say there is an unfair stigma associated with chronic pain, and half said they have lied about or hidden their use of opioid painkillers from others.

“The rise of the opioid epidemic has had a significant impact on those living with chronic pain, and oftentimes the voice of this population has gotten lost. We wanted to shine some light on the experiences of chronic pain sufferers with this research,” said Shai Gozani, PhD, president and CEO of NeuroMetrix, which commissioned the survey.

NeuroMetrix is the creator of Quell, a wearable medical device that uses neurostimulation to relieve chronic pain. The company hired the market research firm of Vanson Bourne to interview 1,500 Americans aged 25 and older, who were suffering from chronic pain for at least three months. An equal number of men and women participated.

The interviews were conducted online in early 2018 -- two years after the Centers for Disease Control and Prevention released new guidelines that discourage the prescribing of opioids for chronic pain. Although voluntary and only intended for primary care physicians, the guidelines have been widely adopted by insurers, regulators and providers throughout  the U.S. healthcare system.

The survey found that most pain patients are cautious about their use of opioids. Sixty-one percent are worried about addiction, a little over half (51%) said they only take opioids when necessary, and 42% don't like their side effects.

The stigma associated with opioids impacts how some patients communicate with their doctors. One out of five (20%) downplay the level of their pain and 13% said they are more cautious when speaking with their doctor. Only 9% of patients said they emphasize their pain level.

Most patients want to try pain therapies besides opioids. Nine out of ten said they are actively looking for new treatment options and most had tried at least one alternative, non-pharmacological therapy.  

Most Widely Used Alternative Therapies

• 65% Physical therapy
• 65% Lotions, rubs and patches
• 44% Over-the-counter TENS
• 33% Doctor prescribed TENS
• 28% Yoga, pilates, meditation
• 21% Acupuncture
• 16% Medical marijuana
• 16% Cognitive behavioral therapy
• 15% Surgery, implantable devices

The two most common reasons for pain patients to seek alternative treatments is because they don't like the side effects of prescription drugs (43%) and they prefer to treat pain without medication (39%). A majority (59%) don't believe their doctor is completely informed of treatment options outside of prescription drugs.

“These results underscore the need for more research and treatment modalities to support those living with chronic pain, as well as a joint effort among care providers, innovators, government stakeholders and patients to expand the goals of pain treatment," said Gozani.

"If we shift focus to making the end goal of pain treatment about decreasing suffering and disability rather than exclusively pain intensity, we may open ourselves to new possibilities and treatments that will empower those with chronic pain to find relief and gain greater control over their lives.”

You can read the full report, “Flipping the Script: Living with Chronic Pain amid the Opioid Crisis” by clicking here.

Quell Relieves Back Pain Without Medication

By Pat Anson, Editor

Like many people who suffer from chronic back pain, Greg Watson has tried a lot of different treatments, including physical therapy, soft tissue manipulation, chiropractic adjustments, trigger point injections and dry needling.

“I did trigger point injections with really big needles,” says Watson, whose back was broken in four places when his bike was hit by a car in 2011. “A lot of interesting ways of relieving pain by triggering an even bigger pain. Some of those things would work temporarily.”

Watson spent five days in the hospital after the accident, where he was “pumped full of morphine.” When he was finally released and sent home, the 45-year old Watson was determined to avoid taking more pain medication. That meant trying all of those alternative therapies, with little success, and living for years with intermittent pain that sometimes reached a 6 or 7 on the pain scale.

A friend recommended that Watson try Quell, a battery powered medical device worn below the knee that uses electric nerve stimulation to relieve pain throughout the body -- a therapy known as neuromodulation.

“I felt it and noticed something right away,” says Watson. “It feels a little bit like pins and needles, and it kind of comes in little waves or pulses. Very low amounts of electricity coming into you.”

It took a couple of days for Watson to feel some pain relief. The biggest improvement he noticed was that he slept better.  

“I would go home and put it on for a few hours and then be able to get a full night’s sleep without having to wake up with leg discomfort in the middle of the night,” said Watson, a city planner in Boston who is an avid runner and bicyclist.

neurometrix image

On bad pain days, Watson will wear the Quell device while sleeping or at work. But mostly he just wears it for a few hours at a time. Watson has found that he’s often able the get through an entire day without even thinking about his pain. 

“There are some days I get a bigger uptick in the amount of pain that comes from that old injury site. But when that’s the case, I just up-ramp the use of it a little more.”

Quell is made by NeuroMetrix (NASDAQ: NURO), which recently won approval for the device to be sold in the Europe Union.

It’s been available in the U.S. since the summer of 2015 and is FDA approved for the treatment of chronic pain.

Quell can be purchased without a prescription, but is not covered by insurance and costs $249 through the company’s website or on Amazon. 

PNN columnist Jennifer Kain Kilgore says Quell “worked brilliantly” in relieving her chronic neck and back pain.

But readers have had mixed results with the device.

“Very expensive, wasn't covered under my Medicare insurance. I tried it for a couple of weeks and simply didn't receive ANY pain relief for my low back and neck. None. I am very disappointed,” wrote one woman.

“I have been using Quell for a month now. I use it mainly at night for the pain that I experience in my hips and legs that keeps me from sleeping,” wrote Pam. “It actually has helped me to ditch the sleeping pills. It helps me fall asleep. I am elated.”

“I am on day 18 of my Quell device. It has eliminated the pain in my knees. No more Bengay, Australian Dream or Blue Emu Cream needed. The pain in my feet and hips has diminished greatly,” said Beth Flood. “It is not perfect, it is not a complete answer, but for what it does and the relief it has offered, it is well worth buying.”

NeuroMetrix recently announced that it was conducting a small clinical study of Quell in 60 adults with chronic low back pain at the Brigham and Women’s Hospital Pain Management Center. The three month study will compare a group of patients using Quell to patients using their “treatment-as-usual.” Participants in both groups will use a smartphone app developed by the Pain Management Center to help them document and manage their pain.

“This study will analyze the potential for Quell to reduce pain and improve quality of life in people suffering from chronic low back pain. We look forward to learning a great deal from this study,” said Shai Gozani, MD, President and CEO of NeuroMetrix in a news release.

In previous small studies of Quell in patients with arthritis, diabetic neuropathy, sciatica or fibromyalgia, over 80 percent said the device relieved their chronic pain and improved their overall health. The largest measured changes were in pain relief, along with improved sleep, general activity and walking ability.

Over two-thirds of the patients said Quell also reduced the amount of pain medication they were taking. That’s an important consideration for Greg Watson.

“Especially if you’re looking to avoid medication. That’s the absolutely most appealing thing about it to me,” he says.

Chronic Pain? There’s an App for That

By Pat Anson, Editor

Smartphones have revolutionized the way we communicate. And they are fast becoming a tool in the treatment of chronic pain.

Wearable medical devices linked to smartphones can not only do simple things like track your pulse and blood pressure, they can help relieve some types of chronic pain without the use of drugs. Several of these new medical devices are being showcased next month at the 2016 International Consumer Electronics Show (CES) January 6-9 in Las Vegas.

One device making its debut at the trade show is the iTens, the first FDA-cleared wireless TENS device that works via an iPhone or Android based app.

Transcutaneous Electrical Nerve Stimulation (TENS) has been used for decades to relieve pain by using electrical stimulation to block or mask pain signals. But the old TENS units typically come with many wires, are anything but portable, and could only be used for limited 30-minute periods.

images courtesy of itens

“The iTENS device was created for people who are in need of a portable, convenient method of pain management that doesn't involve taking prescription medication,” says iTENS CEO Joshua Lefkovitz. “We designed the iTENS to be thin, flexible, discreet, and easy to operate with the push of a button from the iTENS app.”

The iTens uses peel ‘n’ stick gel pads that can be directly applied to painful areas. The pads are powered by a lithium-ion rechargeable battery that can provides relief for up to 24 hours.  During that time, the iTENS app measures a user’s pain scale, tracks their results, and charts their progress.

“We’ve got the first clearance from the FDA that has a Bluetooth enabled app,” Lefkowitz told Pain News Network. “There are other wireless TENS devices out there, but none of them are app-enabled.

“It’s really cool, because with an app you can roll in new settings. We’ve got body part settings, condition-specific settings, and you’ve got manual settings so you can pre-program whatever settings you want.”

The iTens device will become commercially available in March for $89.95. No prescription is needed and the device is “FDA-cleared” – meaning the Food and Drug Administration has approved iTens’ safety, but not necessarily its efficacy.

Device makers have a huge advantage over pharmaceutical companies because they are held to a lower regulatory standard and often can get fast track approval from the FDA without any clinical studies – as long as the new device is substantially the same as an old device already on the market.

One disadvantage to that approach is that without full FDA approval, few insurance companies are likely to offer reimbursement for a wearable medical device and physicians are less likely to recommend them.

That conundrum will be addressed at the CES trade show in a panel discussion titled “Roadmap to FDA Approval.” One of the speakers is Shai Gozani, President and CEO of NeuroMetrix Inc., maker of the Quell pain relief device, a neurostimulator worn below the knee

“If wearable technology is going to achieve its tremendous potential it must move beyond wellness to tackling fundamental health problems such as chronic pain, diabetes, and heart disease. This necessarily implies regulation by the FDA,” said Gozani. “I hope this panel will start to demystify the regulatory process and encourage technology companies to embrace the opportunity of consumer medical technology.”

The FDA issued guidance earlier this year on the types of apps that would be subject to regulatory review. The agency said it was not trying to stifle innovation and the regulations would only apply to a  “small subset of mobile apps that are medical devices and present a greater risk to patients if they do not work as intended."

The goal is not to regulate “wellness” apps that keep track of things like fitness and nutrition, but apps that make specific claims about diseases and conditions.

According to industry estimates, by 2018 over half of the world’s 3.4 billion smartphone and tablet users will have downloaded mobile health applications