Insufficient Evidence: How Opioid Deniers Spin Studies

By Roger Chriss, Columnist

Opioid medications are coming under fire again as being ineffective for chronic pain management.

Charles Pattavina, MD, president of the Maine Medical Association, told the Portland Press Herald that "there is no clinical indication for opioid medication for the treatment of chronic pain."

And Stanford psychiatrist Anna Lembke, MD, said in Vox that “if opioids worked long-term, I would have no problem with patients taking them.”

But sweeping generalizations like these oversimplify a complex situation. Chronic pain is a highly heterogeneous feature of a wide variety of diseases and disorders. And opioids are a broad class of pain medications that come in different doses and are administered by different routes.

Thus, a claim that opioids do not work for chronic pain is too simplistic. Medical researchers investigate carefully posed questions about specific drugs and conditions using the statistical method known as hypothesis testing.

Researchers cannot and do not investigate if “opioids” work for “chronic pain.” Good research is more narrowly focused, such as these clinical studies:

“Tapentadol extended release for the management of chronic neck pain”

“Effectiveness and Safety of Once-Daily Extended-Release Hydrocodone in Individuals Previously Receiving Immediate-Release Oxycodone for Chronic Pain”

“Oxycodone for neuropathic pain in adults”

The results are equally specific. In the first example above, the authors conclude that “our results suggest that tapentadol ER, started at 100 mg/day, is effective and well tolerated in patients with moderate-to-severe chronic neck pain, including opioid-naïve subjects.” Similarly precise statements are found in any such article.

Sometimes researchers will perform a meta-analysis or review in which they assemble a collection of existing research articles and, after a statistical analysis, attempt to draw broader conclusions. Examples include:

“Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects”

“Opioids for chronic pain: new evidence, new strategies, safe prescribing”

“The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop”

The last article above is often cited by opioid deniers, even though it concludes that “evidence is insufficient to determine the effectiveness of long-term opioid therapy for improving chronic pain and function.”

"Evidence is insufficient” means that no determination can be made one way or the other about opioid medications. It does not prove that opioids are ineffective for chronic pain.

This leads to the final defense of opioid deniers: Demand an impossibly high standard of evidence. Specifically, they want the “gold standard” of clinical research: a double-blind, placebo-controlled, randomized trial of a specific drug for a particular condition.

To satisfy this standard, we would have to test every opioid medication against every medical condition causing chronic pain in a variety of different groups of people. This would mean thousands of trials, each performed multiple times, before any meaningful conclusions could be drawn about opioid medications in general. The time and costs involved would be prohibitive in the extreme.

So instead we use observational data and statistical methods to derive reasonable conclusions, as found in the articles above. This approach is widely used in many areas of medical research. In pain research, it has clarified how certain opioid medications can be used to address various chronic pain conditions.

To be clear, opioid therapy can help manage a variety of forms of chronic pain. Not all pain, and not for all patients. And always under the care and guidance of medical professionals.

The goal of opioid therapy is to improve quality of life, and available evidence strongly supports that it does so.

Roger Chriss suffers from Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Warriors Coach in ‘Excruciating' Back Pain

By Pat Anson, Editor

Golden State Warriors coach Steve Kerr is in “excruciating pain” and may miss the rest of his team’s first round playoff series against the Portland Trail Blazers after his chronic back pain "took a turn for the worse." Kerr warned other back pain sufferers "to stay away from surgery."

Kerr was unable to attend Game 3 Saturday night and doesn't know when he’ll return. Sources told the San Jose Mercury News that Kerr was in so much pain he was barely able to walk, which “was scary because it wasn’t a feeling he’s had before.”

The team had only given vague reports that Kerr has an “illness” and is “not feeling well.”

"This past week, for whatever reason, things got worse and my symptoms got worse," Kerr said at a news conference Sunday.  "With things getting worse, I just made the decision that I couldn't coach. As of now, I'm consulting with my doctors. I'm hoping for some improvement. If I get some improvement, I'll get back on the sidelines. 

"I'm not going into details on the symptoms, it's just discomfort and pain. It's not fun. And I can tell you, if you're listening out there,  if you have a back problem, stay away from surgery. I can say that from the bottom of my heart."

In the past, Kerr has complained of headaches, nausea and neck pain.

Kerr missed the first 43 games of the 2015-16 NBA season due to complications from surgery for a ruptured spinal disk. The dura membrane that surrounds Kerr’s spinal cord was punctured during the operation, causing spinal fluid to leak. A second surgery was performed to stop the leak.

“It’s very rare, it does happen occasionally, but it happens when there’s an accidental nick of the dura that surrounds the spinal cord. But I lost spinal fluid, took about a month to figure out what was going on, a lot of headaches, some other symptoms,” Kerr said in October 2015.

Headaches, nausea, and burning, stinging or tingling pain in the back and legs are the classic symptoms of adhesive arachnoiditis, an inflammation that causes scar tissue to build around spinal nerves, causing them to adhere or stick together. The disease is progressive, incurable and difficult to treat.  Many patients developed arachnoiditis after surgeries or epidural steroid injections that permanently damaged their spines.

Neither Kerr or his doctors have said he has arachnoiditis.

There’s a great deal of debate in the medical community over the value of spinal injections, surgeries, spinal cord stimulators and other “interventional” procedures to treat back pain. About 9 million epidural steroid injections are performed annually in the United States, often as a substitute for opioid pain medication.

Patients Could Be Jailed in Florida Drug Crackdown

By Pat Anson, Editor

The Florida legislature is close to passing a bill that would require mandatory minimum sentences for anyone convicted of selling, purchasing or possessing illicit fentanyl.

Critics say the legislation could result in pain patients being sent to jail when they unwittingly buy counterfeit painkillers on the black market that are made with fentanyl.

House Bill 477 was approved unanimously by the Florida House this week.  Similar legislation is under consideration in the Senate. Both bills would put fentanyl, carfentanil, and their chemical cousins in the same drug class as heroin.

Fentanyl is a synthetic opioid 50 to 100 more potent than morphine.  It is available legally by prescription to treat severe pain, but illicitly manufactured fentanyl has become a scourge across the U.S. and Canada, where it is usually mixed with heroin or used to make counterfeit drugs.

As currently written, the House bill requires anyone convicted of having as little as 4 grams of fentanyl to get a mandatory three year prison term; 14 grams would carry a 15-year sentence; and 28 grams would result in 25 years behind bars.

Judges would have zero discretion to alter the sentences. If the drugs result in someone dying, suspects would face a charge of first degree murder.

While the legislation is primarily aimed at cracking down on dealers, critics say patients desperate for pain relief could also face prison if they buy counterfeit oxycodone and other painkillers laced with fentanyl.

"There's a massive problem with counterfeit pills," Greg Newburn, state policy director for Families Against Mandatory Minimums told the Miami New Times.

"You have people who think they’re buying oxy pills who will end up getting labeled as traffickers in fentanyl. A handful of pills could get you three years. If you buy just 44 pills, you could end up with 25 years in prison."

Newburn was surprised the Florida legislature didn’t learn its lesson from previous efforts to require lengthy prison terms for oxycodone and hydrocodone traffickers. Rigid enforcement of the law led to 2,300 people being sent to prison, including some patients who were simply look for pain relief, according to Reason.com.

"When you look back on how the last mandatory-minimum heroin law was applied, you see that it targeted not just just traffickers but a lot of low-level offenders, people who were never supposed to be targeted by the bill in the first place," said Newburn. "We had a heroin mandatory-minimum law for 18 years. Lawmakers promised us it would deter drug use, but now we’re in the midst of the worst heroin crisis we’ve ever seen. And the answer to that is to pass another mandatory minimum?"

Florida was one the first states where counterfeit pills laced with fentanyl began to appear. In early 2016, nine people died in Florida’s Pinellas County after ingesting counterfeit Xanax, an anxiety medication.

“Hundreds of thousands of counterfeit prescriptions pills, some containing deadly amounts of fentanyl, have been introduced into U.S. drug markets, exacerbating the fentanyl and opioid crisis,” the DEA warned in a report last year. “Motivated by enormous profit potential, traffickers are exploiting high consumer demand for prescription medications by producing inexpensive, fraudulent prescription pills containing fentanyl.”

As opioid prescriptions have become harder to obtain, some pain patients are turning to the black market for relief. In a recent survey of over 3,100 patients by PNN and the International Pain Foundation, 11 percent said they had obtained opioids illegally on the black market in the year after the CDC’s opioid guidelines were released.    

Readers Sound Off on Fibromyalgia Drugs

By Lana Barhum, Columnist

In my previous column, “Lyrica, Cymbalta and Savella: Do They Work?” I shared research studies and my own experience with the three medications approved for use in treating fibromyalgia.

Clinical studies on all three drugs don’t seem to offer enough creditable evidence that they are effective in managing fibromyalgia symptoms.  Moreover, they carry very harsh side effects, including weight gain, edema, nausea, headaches, vertigo, sleep issues, and changes in blood pressure.

My experience was similar. Lyrica, Cymbalta and Savella were ineffective for me, and had some tough and life-altering side effects.

It makes me wonder why doctors are still prescribing these medications and why the Food and Drug Administration continues to allow them to stay on the market. 

In 2012, German researchers aimed to assess the benefits and harms of Cymbalta and Savella in treating fibromyalgia.  Ten studies with over 6,000 fibromyalgia patients were reviewed. 

The results were that 22 percent of patients reported substantial relief and 21 percent had to quit treatment due to unpleasant side effects.

In reader comments on our website and Facebook page, many of you had comparable experiences:

“Tried all 3…nothing but weight gain and dizziness. No pain relief. Still haven't found anything that works.”

“I've had multiple spinal surgeries and fusions, and have severe nerve damage. And severe chronic pain. So, I've taken all three of these meds. Without success.”

I will not discount the fact that Lyrica, Cymbalta and Savella work for some people, but they appear to help only about 20 to 30 percent of patients who try them:

“I take one 60mg (of) Cymbalta a day, and it doesn't take away all the pain, but it does make it a bit more bearable.”

“I am using all three. There is relief but in moderation.”

“I have been on Lyrica since 2007 and do have relief of my Fibro pain. I am also on Cymbalta, a muscle relaxant and pain med that really (does) make a difference with my Fibro, arthritis and osteo pain.”

“Tried Savella, no good. Lyrica did not decrease pain enough to continue. I've used Cymbalta and had good results. Best results have been from using Gabapentin (Neurontin) since 1996, up to 3600 mg daily.”

“I'm back on Lyrica and Cymbalta. I know of the side effects with this medicine but it is the only option that remotely helps.”

The effectiveness of Lyrica and Cymbalta, in particular, has been hyped up with aggressive advertising by their manufacturers. And while research and patient experience show improvement on any of the medications is spotty at best, doctors continue to prescribe them.  This is yet another example where the medical field, in general, has not done a good job in treating, understanding or advocating for fibromyalgia patients.          

Side effects reported by readers to the three drugs include dizziness, mood changes, cognitive issues, swelling, sleep issues, weight gain, increased blood pressure, blackouts and more.  Many of these side effects have a detrimental effect on the daily lives of fibromyalgia sufferers – as if our lives were not difficult enough.

“Lyrica was the worst! I became a sleep-walking zombie. I was so out of it at night that I rarely made it to bed laying down. I would find myself in weird places asleep, such as with my head resting on the faucet in the bathroom sink. Or, I would sleepwalk and fall, like down the stairs. Certainly not good for helping my pain!”

“Lyrica did nothing for me. Cymbalta changed my personality completely. I became mean and hateful. When I asked the (doctor) about it, he's like, yeah that can happen.”

“I have taken Neurontin, Lyrica, Savella, and currently take Cymbalta. Neurontin gave me bad nausea, and the feeling of bugs crawling all over my body. Lyrica made me gain a lot of weight, and didn't help my pain at all. The Savella was the worst for me, it gave me very bad suicidal thoughts, so bad I had to stop taking it, it also never helped with pain.”

If only there was an ideal treatment for fibromyalgia -- one that would offer real relief from the worst symptoms and with few side effects.  But such a treatment could only come with a real understanding about the causes and symptoms of fibromyalgia, and I don’t feel medical research has gotten there yet.

The worst part of my experience with fibromyalgia is trying countless treatments to no avail. And there is nothing worse than being told, as I was, by a medical provider that if you expect real relief, you should also expect side effects and learn to cope with them. That statement shows what little understanding and empathy the medical community has about fibromyalgia, its process, and its difficulties.

I wish I had some good treatment advice to offer, but the fact is, like so many of you, I am exhausted. Years of trying medication after medication has left me weary of the medical community and the companies that manufacture fibromyalgia drugs. 

I have accepted defeat and refuse to try anything new.  Neurontin, Cymbalta, and muscle relaxers offer me some relief from nerve pain, depression, and muscle spasms, so I continue to take them.   Even so, I still live with widespread muscle and tissue pain, and a whole host of other symptoms fibromyalgia brings in its wake.

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother. Having lived with rheumatoid arthritis and fibromyalgia since 2008, Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit her website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Bans Use of Codeine and Tramadol in Children

By Pat Anson, Editor

The U.S. Food and Drug Administration is tightening restrictions on the use of codeine and tramadol in young children.

The agency says the opioid medications carry "serious risks" for children under the age of 12, including slowed or difficult breathing and possibly even death. The FDA is also recommending against the use of codeine and tramadol by breastfeeding mothers due to possible harm to their infants.

Codeine is approved to treat mild pain and cough, while tramadol is used to treat moderate pain. Codeine is usually combined with other medicines, such as acetaminophen, in prescription pain medication, as well as in some over-the-counter (OTC) cough and cold remedies. The FDA action only applies to prescription codeine.

"We know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize these medicines much faster than usual, casing dangerously high levels of active drug in their bodies," said Doug Throckmorton, MD, deputy director for regulatory programs, at the FDA Center for Drug Evaluation and Research.

"This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease. Respiratory depression can also occur in nursing babies, when mothers who are ultra-rapid metabolizers take these types of medicines and pass it along to their children through their breast milk."

In a review of adverse event reports from 1969 to 2015, the FDA said it identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18. The agency also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol by children.

The majority of serious side effects with both codeine and tramadol occurred in children younger than 12, and some cases occurred after a single dose.

The FDA is requiring drug makers to add a tougher warning to the labels of codeine and tramadol products, alerting healthcare providers and parents that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12.

The new labeling also cautions against their use in adolescents between 12 and 18 who are obese or have conditions such as obstructive sleep apnea or severe lung disease. Breastfeeding mothers will also be warned not to use the medications.

The FDA said it is considering additional regulatory action for the OTC codeine products that are available in some states. It is also considering an FDA Advisory Committee meeting to discuss the role of prescription opioid cough-and-cold medicines, including codeine, to treat cough in children.

The agency did not recommend or suggest any alternatives to codeine and tramadol to treat childrens' cough or pain. OTC medicines such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) also have risks and side effects.

"We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe," said Throckmorton.

In 2015, the FDA approved the use of OxyContin in children ages 11 to 16  who are in severe pain, a move widely panned by addiction treatment activists who claimed kids would get easily hooked on the painkiller. 

New Test Identifies Poor Drug Metabolizers

By Pat Anson, Editor

We hear regularly from readers who say they were discharged by their doctor after failing a urine drug test. Often it’s a case of an opioid painkiller not being found, which leads the doctor to believe a patient is selling or diverting their medication.

“The doctor said after 12 years of never having a bad urinalysis or anything ever happening, such as lost medication, asking to receive more or an early prescription, they said no medication was in my system. No one would retest and I was cut off cold turkey!” a pain patient recently told us.

“I went through hell trying to clear my name, horrible withdrawal with no doctor supervision or help, was labeled and thought I would die. This is a terrible way to treat anyone, especially someone with an untreatable life-long pain condition.”

Why are patients being falsely accused? In many cases, it’s because they have genetic differences that make them a low or high metabolizer of certain opioids. A painkiller like hydrocodone, for example, can quickly be utilized or pass through their system -- with little or no trace of the drug left behind.

Urine drug tests that are typically done in a doctor’s office -- known as point-of-care (POC) tests – do not identify these poor drug metabolizers. And studies show that about 30 percent of POC tests have “false negative” findings about opioid medication.

“Just because it may not show up in their system may not mean that they’re not taking it. There are two rational justifications for that. One is a bad drug test and the other is a patient may be a poor or ultra-rapid metabolizer of the medication that is being prescribed to them,” said David McCrea, CEO of Insight Diagnostics.

“I think most (doctors) understand how faulty the point of care tests can be, especially pain physicians. But I’m not sure the average physician understands how much a person’s individual metabolism can affect their drug test.”

Insight Diagnostics recently began offering a new testing service – called Genetically Enhanced Medication Monitoring (GEMM) – that combines a saliva-based genetic test with a laboratory test that more precisely identifies drug molecules in a patient’s urine. When used together, the two tests can reassure a doctor that a patient is telling the truth about their drug use.

“This is a game changing test that will allow physicians to uncover why some patients say, ‘I am taking my medication, I am taking it as prescribed and it’s just not showing up.’ This is scientific information that can validate a patient’s assertion,” McCrea told PNN.

“Certainly there are going patients that are going to try and game the system. But for those patients that are in chronic pain and are doing what they signed their pain contracts to do, this allows for a deeper dive for the physician to determine whether the patient is actually taking their medication, or they can’t metabolize it or they over-metabolize it.”

McRae says GEMM costs "a couple hundred dollars at the most” and is covered by Medicare and most private insurers. It doesn’t offer immediate results, as POC tests do, but the findings are far more accurate. They can also help physicians identify medications that will be metabolized normally by a patient and will be more effective. 

Genetic tests cannot be used to explain “false positive” findings from a POC test – the detection of a drug that isn’t actually there. But laboratory testing can. Retesting a urine sample is more expensive, but it can help prevent patients from being falsely accused – something that happens far too often.   

A recent survey of doctors and health care providers by PNN and the International Pain Foundation found that 20 percent had discharged a patient for failing a drug test in the past year. About four percent of patients said they had been "fired" by a doctor over a failed test.

“I failed a drug test which said I was positive for 4 drugs I have never taken in my life and was negative for opiates when I was taking Norco. My doctor abruptly stopped treating me even after I demanded my sample be retested,” a patient told us. “These drug tests are not reliable and should not be used and pain contracts should be illegal since they are forced on the patient.”

Click here to see a short promotional video about GEMM.

Is Your Medical Marijuana Safe to Use?

By Ellen Lenox Smith, Columnist

When you smoke, ingest or administer medical marijuana into your body, it is important to know that it is safe to use. Ideally, the marijuana was grown organically and is pesticide free.

Here are simple tips that might help you to determine where you stand.

Purchasing from a Private Grower:

• Be sure to check with them to see what products they use for the soil and nutrients, to be sure the plants are growing organically.
• Most growers will at some point have to face a bug infestation. Make sure they got rid of them by using an organic product. You do not want to ingest toxic substances.
• You also need to know how they work on being consistent in creating their oils, tinctures, topical ointments and edibles. It is important when you find a medication that is compatible with your body, and that you be able to purchase it again and have similar results.

Purchasing from a Marijuana Dispensary:

If you are going to a medical marijuana dispensary or compassion center to purchase cannabis, you have the right to ask those same questions.

• Do they know who their suppliers are and where the marijuana was grown?
• Do their suppliers grow organically?
• Ask how they make sure there is consistency in creating their tinctures, oils, edibles, drinks, etc.

Americans for Safe Access (ASA) has created standards for medical marijuana called Patient Focused Certification (PFC), a non-profit, peer reviewed, third party certification program for the medical cannabis industry.

PFC addresses product and safety concerns “to promote the adoption of safe and reasonable industry standards and regulations from seed to consumption.”

If you see a marijuana package carrying the PFC label, like the image to the right, it has met their standards and has been certified.

Don’t be shy. This is your life and your body. Be sure to know that whoever you purchase your medication from, that it is being grown safely for you!

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis. Ellen and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition.

For more information about medical marijuana, visit their website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

High Fat Diet Raises Osteoarthritis Risk

By Pat Anson, Editor

Saturated fatty acids are prime suspects in the onset of osteoarthritis, according a new study by Australian researchers who say fat changes the composition of cartilage, particularly in the hip and knee.

It’s one of the first studies to look at the association between osteoarthritis and saturated fatty acids found in foods such as butter, coconut oil, palm oil and animal fat.

When combined with simple carbohydrates in a high-fat, high carbohydrate diet – often called "junk food" – researchers found that fatty acids weaken cartilage and produce osteoarthritis-like changes in the knee.

"We also found changes in the bone under the cartilage on a diet rich in saturated fat," said Professor Yin Xiao of Queensland University of Technology’s Institute of Health and Biomedical Innovation. "Our findings suggest that it's not wear and tear but diet that has a lot to do with the onset of osteoarthritis

"Saturated fatty acid deposits in the cartilage change its metabolism and weaken the cartilage, making it more prone to damage. This would, in turn, lead to osteoarthritic pain from the loss of the cushioning effect of cartilage.”

Osteoarthritis is a joint disorder that leads to progressive joint damage. It can affect any joint in the body, but is most commonly felt in weight bearing joints such as the knees and hips. Nearly 40 percent of Americans over the age of 45 have some degree of knee osteoarthritis.

Xiao and his colleagues tested a variety of saturated fats and found that long term use of animal fat, butter and palm oil was the most damaging to cartilage. There was less damage caused by  lauric acid, a saturated fatty acid found in coconut oil.

"Interestingly, when we replaced the meat fat in the diet with lauric acid we found decreased signs of cartilage deterioration and metabolic syndrome so it seems to have a protective effect," said Sunder Sekar, a PhD student.

"Replacement of traditional diets containing coconut-derived lauric acid with palm oil-derived palmitic acid or animal fat-derived stearic acid has the potential to worsen the development of both metabolic syndrome and osteoarthritis."

Professor Xiao's previous research has found that antioxidants and anti-cholesterol drugs could slow the progression of joint damage caused by fatty acids.

The study was funded by the Prince Charles Hospital Research Foundation.

No Opioid Painkillers Prescribed to Prince

By Pat Anson, Editor

Nearly a year after pop superstar Prince was found dead of an accidental drug overdose in his Minnesota home, we still don’t know where he obtained the fentanyl that killed him.

Court documents released today show that none of the opioid painkillers found in Prince’s home were prescribed to him. At least one opioid prescription bottle bore the name of Kirk Johnson, Prince’s former drummer and a longtime friend. Other opioid medications were found stashed throughout Prince’s Paisley Park home near Minneapolis.

“The controlled substances were not contained in typical prescription pill bottles, but rather, were stored in various other containers such as vitamin bottles. Bottles containing these controlled substances were located in multiple areas of the complex, including Prince’s Bedroom,” a search warrant said. 

“Investigators have been searching for the source of the controlled substances found in Prince’s residence. Through this investigation, interviews with those who were at Paisley Park the morning Prince was found deceased have provided inconsistent and, at times, contradictory statements.” 

Assistants to the entertainer told investigators that “Prince recently had a history of going through withdrawals” and they had arranged a meeting for him to meet with an addiction treatment specialist.

Prince was found dead in an elevator at his home on April 21, 2016 and speculation immediately focused on a possible opioid overdose. A medical examiner later reported that Prince died from an accidental overdose of fentanyl, but did not say where the drug came from.

Prince did not have a prescription for fentanyl, a potent synthetic opioid that is used in skin patches and lozenges to treat severe pain. Illicit fentanyl is widely sold on the black market, where it is often mixed with heroin or used to make counterfeit painkillers.

Prince died less than a week after his private plane made an emergency landing in Moline, Illinois, where paramedics reportedly treated him for an opioid overdose.

The Minneapolis Star Tribune reported last year that Prince weighed only 112 pounds at the time of his death and had so much fentanyl in his system that it would have killed anyone.

According to the newspaper, some of the pills found in Prince’s home were labeled as “Watson 853” – a stamp used to identify generic pills containing hydrocodone and acetaminophen that are sold under the brand name Lortab. When one of those pills was tested, it was found to contain fentanyl and lidocaine.

A week before he died, Dr. Michael Schulenberg wrote an oxycodone prescription for Prince under Johnson's name to protect the singer’s privacy, according to investigators.  But in a statement released today, Schulenberg's attorney denied prescribing opioids to Johnson or "any other person with the intent that they would be given to Prince."

The Star Tribune reported that investigators turned over the results of their investigation to the U.S. attorney’s office earlier this year.  No arrests have been made and no charges have been filed.

Fuzzy Opioid Math and Media Theatrics

By Roger Chriss, Columnist

The Centers for Disease Control and Prevention recently produced a map that shows how prescription opioid use varies widely from state to state. Californians, for example, are prescribed opioids at about half the rate as people in Ohio and West Virginia.

The CDC also tells us that doctors “wrote 259 million prescriptions for painkillers in 2012, enough for every American adult to have a bottle of pills.”

Because an epidemic is a statistical phenomenon, defined by numbers derived from data, caution is required when presenting and interpreting such results.

The media has been anything but cautious in using these numbers as fodder for sensational anti-opioid reports.

CDC GRAPHIC

“These pills didn’t just end up in patients’ hands; they also proliferated to black markets, were shared among friends and family, landed in the hands of teens who rummaged through parents’ medicine cabinets, and so on,” Vox reported, overlooking the fact that less than one percent of legally prescribed painkillers are diverted.

Some use the prescribing numbers to make a case for extreme measures to stop opioid addiction and overdose.

“In 12 states there are more opioid prescriptions than people,” David Brooks wrote in The New York Times, before suggesting an approach to addiction treatment that sounds like it came out of Les Misérables.

“Something like half of all sufferers drop out of treatment within a few months, so it might be worth thinking about involuntary commitment,” Brooks said.

“Legally, by prescription, we have created an epidemic of death,” chimed in New Hampshire attorney Cecie Hartigan in an op/ed published by the Concord Monitor.  “What point is there in alleviating pain for people if it’s going to kill so many of them?  Except in cases of end-of-life care, opioids should not be prescribed.”

Unfortunately, a prescription is not a unit of measure, and statements like these only add to the hysteria and fuzzy math.

An “opioid prescription” is as imprecise as a “bottle of alcohol.” Obviously, a bottle may be small or large, and the alcohol it contains may be strong or weak. As a result, having a small bottle of beer with dinner would be unremarkable, but drinking a large bottle of vodka would be alarming.

This is the mistake in the CDC graphic and opioid prescription counts. A prescription is a paper or electronic document, specifying a particular drug in a particular strength given in a particular quantity -- which makes it unsuitable for statistical use. A prescription for 5 tablets of 50 mg of tramadol cannot be usefully compared with a prescription for 30 tablets of 25 mg of oxycodone.

The CDC’s fuzzy math paves the way for a lot of confusion. Media reports give dramatic percentages of people using prescription opioids, warning of dire consequences from even a few pills.

“If patients get their hands on a second dose, one out of seven will form an addiction. In the event that patients must take a long-acting opioid, about 25% will still be using the drug one year later,” Dr. Manny Alvarez wrote in the Fox News website, apparently unaware less than two percent of people prescribed opioids actually become long term users.  

National Public Radio reported that 57% of American adults in a recent poll said they had been prescribed a narcotic painkiller, and then went on to claim that “as many as 1 in 4 people who use opioid painkillers get addicted to them.”

There are 242 million adults in the U.S. population, so if 57% were prescribed opioids and one fourth of them became addicted, that would give us 34.5 million people addicted to painkillers. This is clearly not the case.

The American Society of Addiction Medicine reports that there are approximately 2 million prescription opioid addicts. These people need treatment, not media theatrics.

Moreover, 259 million prescriptions does not mean that 259 million people have a year’s supply of an opioid. In most cases, people receive a short course of a weak opioid, enough to help with acute pain after trauma or surgery.

As for long-term opioid use, the National Institutes of Health states that “an estimated 5 to 8 million Americans use opioids for long-term management.” Studies show that only a small percentage become addicted to their medication.

Surely we don’t need opioid detention centers or opioid prohibition. That would not help the people struggling with opioid addiction or people living with chronic pain disorders.

Ignore the fuzzy opioid math and related theatrics, and focus on the 2 million people struggling with opioid addiction and the 5 to 8 million people living with chronic pain conditions. They deserve our care and consideration, and certainly won’t benefit from media melodrama.

Roger Chriss suffers from Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Get the Facts Right About Opioids

By Barby Ingle, Columnist 

This past week Tucker Carlson aired a series of reports on Fox News about opioids and addiction. After night two of watching the “Drugged” special segments, I wondered if Fox would be willing to tell the patient side of the story and wrote to some Fox News producers I know to see if they wanted to interview me.

I didn’t know the specific producer for Carlson, but the next morning I received an email from her. I immediately responded and said yes, I would come on the show. We set it up for Thursday or Friday. Well, on Thursday we bombed Afghanistan with the “Mother of All Bombs” and they were unable to get me in.

The producer did say that they would be doing additional segments on the topic and that they are interested in bringing me on sometime in the next few weeks.

I watched the rest of the series, and on Wednesday Carlson said that 60 percent of veterans have chronic pain. That didn’t sound right to me and I wondered where Carlson got his facts from. He never said in his broadcast.

When I looked it up, I found a 2014 study in JAMA Internal Medicine that said 44% of military personnel develop chronic pain after a combat deployment. Also, not all of them are taking opioids as Carlson reported. Only 15% are taking opioids – compared to 4% in the general population.

When I get my chance to speak to Carlson or any other news outlet, I always suggest that we not take opioids off the table as a form of treatment for those with chronic pain. It is not the right thing to do in my educated opinion as a chronic pain patient. There are hundreds of treatment options, but many patients can’t afford them and insurance often won’t pay for them. You can’t leave patients without options.

Many people I know, including one of my best friends, committed suicide because of lack of proper and timely care. She wasn’t looking for opioids, she was looking for relief. She jumped from a 10-story building in New York.

Another friend spent months fighting for her medication after her insurance would no longer pay for her infusion therapy. Once her doctor finally gave her a prescription for fentanyl patches, she went home, put on all 60 patches and tried to commit suicide. She was found in time by her husband and was in a coma at a hospital for about a week.

When she awoke, she was pissed that they didn’t let her die. She wanted to die because she didn’t know how she was going to get any pain relief going forward. My friend is in an even worse situation now because the attempted suicide is on her medical record. She wants infusion therapy, but is denied it -- even though it gave her life back when she did have access to it.

I have been living with chronic pain for 20 years. This year I have been unable to find a provider who will even charge my insurance company for the infusion therapy that keeps me out of my wheelchair. I choose not to use opioids daily because they don’t work for me. But I don’t want to take them away from someone who they do help. That decision needs to be on an individual basis, between a provider and their patient.

We need to encourage pharmaceutical companies to address the addiction and tolerance in pain medications, and one way is the use of abuse deterrent formulas. Another is to get insurance companies, Medicare and workers compensation to cover alternative treatments so that we have more options. And for those who tried and failed with other treatments, we need to keep opioid medication available.

Patients also need to be responsible for their own actions and choices. Recently my doctor gave me a new script. Before filling it, I went home, Googled it, and saw the medication has potential negative side effects. I will be talking with my provider again in a week and will let him know that the medication is not right for me.

Patients need to be proactive about reading medication labels and inserts, and looking up information on our treatment options. We must educate ourselves and we must ask our providers questions. Being a responsible patient will lower the risk of abuse, and increase our access to proper and timely care.

Addicts are going to abuse no matter what is available. We chronic pain patients are simply asking for a seat at the table. Instead we are portrayed as wrong doers, who just want to get high on pain pills.

Carlson ended his week long series by saying he will continue to bring different voices and information to his viewers. His producer personally echoed that sentiment to me. I hope to be given the chance soon to come on his program and tell the patient side of the story, and the many challenges we face getting proper and timely pain care.  

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Studies Identify Riskiest Patients for Opioids

By Pat Anson, Editor

Two studies released this week suggest that pre-existing medical conditions and substance abuse play a strong role in determining whether a patient becomes a long-term opioid user or is hospitalized by an overdose.

The findings could help doctors identify pain patients more likely to develop opioid addiction, instead of flatly assuming that opioids are risky for everyone.

The first study, published in JAMA Surgery, looked at over 36,000 adults who were given a limited supply of opioids to control their pain after surgery. None of the patients had an opioid prescription in the year preceding their operation.

Only about 6 percent of the patients were refilling opioid prescriptions three to six months after their surgery.

The rate didn’t differ significantly between those who had a minor operation and those who had major surgery.

When researchers dug deeper, they found that many of the long term opioid users had similar medical issues. People with arthritis were about 60 percent more likely to keep filling prescriptions, while smokers were about 25 percent more likely. Those who suffered from depression and anxiety were about 20 percent likely to keep taking opioids.

"This points to an under-recognized problem among surgical patients," said lead author Chad Brummett, MD, director of the Pain Research division in the University of Michigan Medical School Department of Anesthesiology. "This is not about the surgery itself, but about the individual who is having the procedure, and some predisposition they may have."

More than 50 million surgical procedures are performed in the U.S. every year. If the study's findings hold true for all patients, researchers say over 2 million people who were "opioid naïve" before surgery could wind up receiving the drugs for months afterward.

Medical Conditions Linked to Overdoses

The second, much larger study looked at a database of over 18 million patients who had an opioid prescription between 2009 and 2013. Over 7,200 opioid overdoses that required hospitalization were identified.  

Researchers found that a previous diagnosis of substance abuse was the single factor most strongly associated with an overdose.  Bipolar disorder, schizophrenia, stroke, renal disease, heart failure and non-malignant pancreatic disease were also strongly associated with overdose risk. 

The risks linked to many of these pre-existing health conditions were so strong they outweighed the risk associated with taking high daily doses of opioids over 100 mg morphine equivalent dose (MED).

“The authors have been able to demonstrate in a very large population there are many risk factors far more important than opioid dose that predict overdose,” said Lynn Webster, MD, a leading expert in pain management and past president of the American Academy of Pain Medicine. 

“I have been lecturing and writing for a decade that dose is less of a contributing factor for overdoses than mental health and history of substance abuse disorders. This study supports what I have been saying.”

The study also identified the prescription opioids most strongly associated with overdose were fentanyl, morphine and methadone. Interestingly, the use of benzodiazepines and antidepressants was riskier than taking hydrocodone, oxycodone and tramadol.   

The study, published in the journal Pain Medicine, was conducted by Venebio, a Virginia-based research group.

"Pain and its management are complex and multidimensional, and the risk of an opioid overdose is likewise dependent on many factors," said Barbara Zedler, MD, lead author and chief medical officer of Venebio. "Primary care professionals express concern about prescription opioid misuse and find managing patients with chronic pain to be stressful. Many feel inadequately trained in prescribing opioids and treating or managing opioid use disorder or addiction." 

Venebio has developed an opioid risk screening tool – called the Venebio Opioid Advisor (VOA) – to help doctors identify patients at risk of having an opioid overdose. According to company officials, VOA predicts the likelihood of an overdose with nearly 90 percent accuracy.

“The apparent accuracy is extraordinary and if broadly implemented should save lives,” said Webster. “I hope the CDC, CMS (Centers for Medicare and Medicaid Services) and policymakers study this paper before they suggest further changes that could cause more suffering and harm for people in pain.”

According to the CDC, over 15,000 overdose deaths in U.S. in 2015 were linked to prescription opioids, although there’s no way of knowing whether the drugs were taken medically or recreationally. Another 18,000 overdoses involved heroin or illicit fentanyl, which have replaced painkillers as the driving force behind the nation’s opioid epidemic.

Bill Would Strictly Limit Opioids for Acute Pain

By Pat Anson, Editor

A bipartisan bill has been introduced in Congress that would put strict limits on the prescribing of opioid medication for the treatment of short-term, acute pain.

The bill by Senators John McCain (R-AZ) and Kirsten Gillibrand (D-NY) would require doctors to limit the initial supply of opioids for acute pain to seven days, a prescription that could not be renewed. The legislation is similar to recent laws adopted in several states, including New Jersey, Arizona and New York.

“Our bipartisan bill would target one of the root causes of the opioid addiction crisis, which is the over-prescription of these powerful and addictive drugs for acute pain,” said Gillibrand. “Too many lives have been destroyed, too many families have been torn apart, and too many communities all over New York are suffering because of this tragic epidemic.”

“One of the main causes for the alarming increase in drug overdoses in the United States is the over-prescription of highly addictive opioids,” said McCain. “We have a long way to go to end the scourge of drugs across our communities, but this legislation is an important step forward in preventing people from getting hooked on these deadly drugs.”

Anti-opioid activists and government regulators have long claimed that even just a few painkillers can easily lead to addiction and death.

“You take a few pills, you can be addicted for life. You take a few too many and you can die,” former CDC Director Thomas Frieden recently told the Washington Post.

But only a small percentage of pain patients become addicted or overdose on prescription opioids. And research shows that less than two percent of patients who are prescribed opioids for acute pain become long-term users.

Under current federal law, doctors must receive a license from the Drug Enforcement Agency (DEA) to prescribe a schedule II, III, or IV controlled substance. The registration must be renewed every three years.

The 7-day limit would not apply to opioid medication used in the treatment of chronic pain or cancer pain, or for patients in hospice care, end-of-life care or palliative care. However, it would prevent doctors from prescribing any opioids for any type of pain if they don't promise to limit prescriptions for acute pain:

“The Attorney General shall not register, or renew the registration of, a practitioner…  who is licensed under State law to prescribe controlled substances in schedule II, III, or IV, unless the practitioner submits to the Attorney General, for each such registration or renewal request, a certification that the practitioner, during the applicable registration period, will not prescribe any schedule II, III, or IV opioid, other than an opioid prescription… for the initial treatment of acute pain in an amount in excess of the lesser of a 7-day supply (for which no refill is available) or an opioid prescription limit established under State law.”

Schedule II opioids include painkillers with “a high potential for abuse” such as hydrocodone, fentanyl, morphine, and codeine. Schedule III opioids have “a potential for abuse” and Schedule IV opioids have “a low potential for abuse.” Opioids such as Suboxone and buprenorphine, which are generally used to treat addiction but are also being abused, are exempted from the legislation.

Anti-anxiety and antidepressant drugs such as Xanax, Soma and Valium – which are classified as Schedule IV controlled substances – are also not covered by McCain and Gillibrand’s bill, even though they are involved in a substantial number of overdoses. The bill was assigned to the Senate Judiciary Committee.

“It’s only too obvious, a careless clueless Congress and state governments have forgotten the lessons of the drug wars and prohibition as they seem intent on repeating the mistakes of the past instead of learning from them when it comes to opioids,” said David Becker, a social worker and patient advocate in New York.

“Furthermore, it is clear they could care less how their opioiphobia harms not only people in pain but their loved ones and those that care and depend on them. It’s clear they never had a real plan to help people in pain but allowed doctors, insurers, and researchers to do their own thing -- unless headlines showing the harms of their lazy laissez faire policies threatened their careers.”

Why Pain Patients Should Worry About Chris Christie

(Editor’s Note: Last month President Donald Trump named New Jersey Gov. Chris Christie as chair of a new commission that will study and draft a national strategy to combat opioid addiction..

Gov. Christie has been a prominent supporter of addiction treatment and anti-abuse efforts.

He also recently signed legislation to limit initial opioid prescriptions in New Jersey to five days, a law that takes effect next month.)

white house photo

By Alessio Ventura, Guest Columnist

Unfortunately, Chris Christie's crackdown on opioids will have extremely negative consequences for people with acute and chronic pain in New Jersey. It is equivalent to gun control, where because of crime and mass shootings, innocent gun owners are punished.

The fact is that only a small percentage of opioid deaths are from legitimate prescriptions. Most overdose deaths are from illegal drugs or the non-medical use of opioids.

The government crackdown on opioids has created a literal hell on earth for people with severe pain, who often can no longer find the medication they need. This has become a major issue, even though there are other drugs that are just as dangerous when misused:

• Every year 88,000 people die from alcohol poisoning. There is no government war on alcohol.
• Every year over 40,000 people die from antidepressants. There is no government war on antidepressants.
• Every year 15,000 people die from non-steroidal anti-inflammatory drugs (NSAIDs) and 100,000 are hospitalized. There is no government war on NSAIDs.

Deaths from alcohol, antidepressants and NSAIDs far exceed deaths from opioids, yet it is opioid medication that gets all of the attention.

So when we see Chris Christie leading a new opioid commission, we chronic pain patients know full well that this just means more restrictions for us. Addicts and criminals will continue to support their habit through the illegal market, and pain patients will continue to live a life of hell that will only get worse. Most of us don’t go to the black market to buy pain medication. We drive around in excruciating pain looking for a pharmacy that can fill our prescriptions.

We also cringe in fear every time we see the "opioid epidemic" headlines and the new initiatives to combat overdoses, because we know that we will pay the price, not the addict or criminal.  It’s like when a nut case opens fire and kills people. Gun owners know that new restrictions will impact them, not the criminals.

New Jersey’s 5-Day Limit on Opioids

Gov. Christie recently pushed for and convinced the New Jersey legislature to pass very restrictive pain medicine laws. Physicians in New Jersey were very much opposed to Christie's model, but it was forced upon them anyway. Since I am originally from New Jersey and most of my family still lives there, I know firsthand the devastating consequences these restrictions could have on family members.

I have had 18 invasive surgeries since 2008 and recently suffered from a sepsis infection after shoulder replacement surgery. The infection required 3 additional surgeries, two of which were emergency surgeries as the infection spread. I was fed broad spectrum antibiotics intravenously 3 times per day.

I also suffer from chronic pain from arthritis. I have tried every other pain treatment modality, and opioid-based pain medicine is the only one that works for me.

There is no way I would have been able to get up after a 5 days to visit my doctor just to refill pain medicine. But if New Jersey’s law were instituted in Florida, where I now live, it would require me to do just that. After the surgery, I was dealing with horrible pain in my shoulder, along with severe fatigue and other complications. Thank God that Florida law still allows for prescriptions of pain medicine beyond 5 days.

Chris Christie is now leading a study for President Trump, and my fear is that a new executive order will be forthcoming which will force the New Jersey model of restricting pain medicine across every state, including Florida.

Let me relay to you a recent experience of my 85 year old mother, who had invasive back surgery in New Jersey. They sent her home after 2 days in the hospital with a prescription for a 5 day supply of Percocet, and strict orders to "NOT MOVE FROM BED.”

There is already a shortage of pain medicine in New Jersey pharmacies. My sister took the script, started at a pharmacy in Bridgewater, and worked her way on Route 22 toward Newark. She visited 30 pharmacies along the way and was unable to find the medicine. She called me in tears because my mother was in terrible pain.

My sister even took my mother to the ER, but they would not give her any medicine for pain.

Thankfully, after asking several friends for help, my sister received a call from her best friend, who found a pharmacy that had Percocet. My mother received significant relief from the pain medicine, but 5 days was not nearly enough. My sister lives with my mother and was able to take her on the 4th day to see the doctor about a refill, but she never should have gotten out of bed. She was under strict orders to stay in bed, use a bed pan and not to get up until two weeks after the surgery.

Yet now on the 4th day she had no choice because of her pain. The patient has to be present to receive a new script for opioids in New Jersey, so my sister could not visit the doctor's office to pick up a script for her without my mother's presence.

This is an unbelievable intrusion into the doctor-patient relationship. Why is it that politicians are so hell bent on government intrusion when it comes to legitimate use of medicines? This is insanity.

It is time for a full court press in Washington DC. If you have acute, chronic or intractable pain, then you better wake up and do something to preserve your rights. Chronic pain is a disease, and for people who have tried all modalities and found that opioids are the only solution, you are about to lose access to the medicine that gives you some semblance of a normal life. I anticipate that an executive order mirroring the misguided New Jersey restrictions will be issued by President Trump, in essence trampling on your ability to obtain pain relief.

I am imploring you to make our voices heard. We should not be further punished because of people with addiction illness. Of course they need to be helped, but restricting access for law abiding, non-addicted patients is an outrage. It is already difficult enough to get pain medicine in Florida, often requiring visits to 20 or more pharmacies before one finds a pharmacist willing to fill a script.

I have often thought about suicide because of my pain. Many others have as well. If additional restrictions are forthcoming from Washington, then many of us will face life or death decisions. Please do not allow Chris Christie to tip the balance.

Alessio Ventura lives with chronic arthritis and post-surgical pain. He shared his experiences as a pain patient in a previous guest column. Alessio was born in Italy, came to the U.S. at age 17, and finished high school in New Jersey. He worked for Bell Laboratories for 35 years as a network and software engineer. 

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Chiropractic Therapy Gives ‘Modest’ Relief to Back Pain

By Pat Anson, Editor

When it comes to treating short-term back pain, spinal manipulation may not be all it’s cracked up to be.

In a review published in JAMA of over two dozen clinical trials involving over 1,700 patients, researchers said chiropractic adjustments provided only “modest” relief for acute low back pain – pain that lasts no more than 6 weeks.

The improvement in pain and function were considered “statistically significant,” but researchers said it was about the same as taking over-the-counter pain relievers. Over half of the patients also experienced side effects from having their spines manipulated, including increased pain, muscle stiffness and headache.

Although the study findings are mixed on the benefits of chiropractic treatment, the American Chiropractic Association (ACA) said it “adds to a growing body of recent research supporting the use of spinal manipulative therapy.”

“As the nation struggles to overcome the opioid crisis, research supporting non-drug treatments for pain should give patients and health care providers confidence that there are options that help avoid the risks and dependency associated with prescription medications,” said ACA President David Herd, DC.

Last month the ACA approved a resolution supporting new guidelines by the American College of Physicians (ACP), which recommend spinal manipulation, massage, heating pads and other non-drug therapies as first line treatments for chronic low back pain.

“By identifying and adopting guidelines that ACA believes reflect best practices based on the best available scientific evidence on low back pain, we hope not only to enhance outcomes but also to create greater consensus regarding patient care among chiropractors, other health care providers, payers and policy makers,” said Herd.

But the ACP guidelines are hardly a ringing endorsement of spinal manipulation. The overall evidence was considered low quality that chiropractic adjustments can “have a small effect on function” and that they provide “no difference in pain relief.”

In fact, the best treatment for acute low back pain may be none at all.

"Physicians should reassure their patients that acute and subacute low back pain usually improves over time regardless of treatment," said ACP President Nitin Damle, MD.

One in four adults will experience low back pain in the next three months, making it one of the most common reasons for Americans to visit a doctor. According to a 2016 Gallup survey, more than 35 million people visit a chiropractor annually.