Study hints at relief for painful realities

Chronic pain.

The government estimates the annual cost of pain in medical treatment and lost productivity at a staggering $635 billion.

Those who deal with chronic pain — generally defined as pain lasting more than 12 weeks — include Las Vegans David Heaps, who suffers from a rare bone disease called hypophosphatasia, and Regina Jirus, who suffered nerve damage after a full knee replacement in 2006.

As crippling as pain is, Heaps says how it’s addressed often only seems to make the pain more chronically acute.

Jirus, however, has qualified for a National Institutes of Health clinical study of a neurostimulator that could prevent pain signals from entering the brain and make her pain history.

It is painful to see just how different their situations are.

Consider Heaps: The adult onset of his genetic disorder in 2009 repeatedly leaves him with spontaneous or low trauma fractures of the feet, legs and pelvis. Just getting out of bed can result in tiny fractures in his ankles and feet and throbbing that often moves up both legs, leaving him feeling as though his body below the waist is on fire.

So what is his lot in life now, besides often feeling as though someone has hit him across the shins with a baseball bat? Well, because of the political attention devoted to abuse of painkillers that include Oxycontin, one of the few drugs that lessens his pain, he often can’t get his perfectly legal prescription filled at many drugstores, or there’s a long delay. His physician finally gave him a prescription for a medication that didn’t work as well.

What he and so many others with chronic pain continue to discover was first addressed three years ago when the Institute of Medicine finished a report requested by President Barack Obama. The report’s author, Melanie Thernstrom, said many individuals felt like “collateral damage” in the war on drugs.

She described cases in which patients who had been on a stable dose of painkillers were suddenly cut off by doctors fearful of getting in trouble with drug agents. In 2013, the “collateral damage” moniker became even more precise after Walgreens agreed to an $80 million settlement with the Drug Enforcement Administration to resolve charges that it failed to properly control narcotic painkillers, making doctors and pharmacists even more skittish about filling painkiller prescriptions.

Although that settlement had nothing to do with people who had legitimate pain concerns — the investigation even found controlled substances were given to customers without a prescription — it didn’t surprise Paul Edwards, the Nevada Board of Pharmacy’s general counsel, that pharmacists became even more cautious and that “innocents” got hurt as solutions were sought to end prescription drug abuse.

When overdoses from prescription painkillers are more than those from heroin and cocaine combined, pharmacists’ reluctance to dispense them should surprise no one, Edwards told me last year.

That attitude doesn’t square with what the Institute of Medicine concluded in its report to the president: “The majority of people with pain use their prescription drugs properly, are not a source of misuse, and should not be stigmatized or denied access because of the misdeeds or carelessness of others.”

Heaps, who wonders how medical practitioners can forget about patients’ welfare when trying to deny them pain medication, is understandably worried about the future.

“I don’t know what I’m going to do if the situation gets any worse,” he said. “I don’t see why each case isn’t taken on a case-by-case basis instead of assuming everyone is a drug addict.”

After evaluation for a clinical trial, Jirus, 61, is excited about the future.

Since knee replacement surgery eight years ago her “burning” pain has become worse, extending from her knee to her hip. She said her doctor admitted he put the wrong size replacement part in initially and she could suffer nerve damage.

Jirus tries not to use addictive painkillers because of unwelcome side effects that include constipation.

Dr. Jon Obray, whose Las Vegas Spine and Pain Center is one of 21 national sites chosen to participate in what is known as the Accurate Study, believes Jirus’ condition makes her a good candidate for the clinical study of a device that can replace pain signals to the brain with electrical signals delivering a tingling or massaging feeling.

The study evaluates the Axium NeuroStimulator System that targets a branch of spinal cord called the dorsal root ganglion, delivering electrical signals to nerves there. The system is tried outside the body before implantation, Obray said.

“They’ve had good results in Europe,” said Obray, who noted device implantation takes about an hour.

To qualify for the Accurate Study, patients must be between 22 and 75, must have had chronic pain affecting lower limbs for at least six months, not had lasting success with other treatments and not previously used spinal cord stimulation for pain.

For information on the study, call 888-978-8397.

If you qualify, you will be treated with one of two neurostimulator systems — either the Axium System or a similar, commercially available system. You will receive the system and any examinations required for the study at no cost.

“I’m not sure I remember what it’s like to be completely out of pain,” said Jirus, who expects to be fitted with a trial device in June. “But I’d like to find out.”

Contact reporter Paul Harasim at pharasim@reviewjournal.com or 702-387-2908.