Tramadol ER Visits Soar as Prescriptions Rise

By Pat Anson, Editor

Emergency room visits in the U.S. involving tramadol have nearly tripled in the last decade, coinciding with a sharp increase in the number of prescriptions for the opioid pain reliever.

According to a report by the Substance Abuse and Mental Health Services Administration (SAMHSA), emergency room visits involving adverse reactions to tramadol rose from 10,901 visits in 2005 to 27,421 visits in 2011. A second SAMHSA report  found a similar increase in the number of ER visits related to the abuse or misuse of tramadol. The vast majority of patients were treated and released.

Ironically, tramadol is considered less risky than other opioid painkillers and doctors have been increasingly prescribing it. The IMS Institute recently reported the number of tramadol prescriptions in the U.S. nearly doubled from 28 million in 2010 to over 44.2 million in 2014.

Tramadol is the active ingredient in brand name pain relievers such as Ultram, Ultracet, Ryzolt and Rybix.

“Tramadol is not abused as much as most pain medication, but it is often overtaken in an effort to obtain additional pain relief.  Like with all pain medication, excessive amounts can cause serious harm,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

Webster predicted that tramadol would be prescribed even more often when hydrocodone was reclassified in 2014 by the Drug Enforcement Administration from a Schedule III drug to a more restrictive Schedule II medication. Tramadol is a Schedule IV drug, meaning it has less potential for abuse than other narcotic pain relievers.

“In the past several years there has been tremendous pressure to reduce prescribing strong opioids. Tramadol has been used in place of other opioids. But it is not without risks as well,” said Webster in an email to Pain News Network.

“The rise in problems associated with tramadol underscores the larger problem of an unmet need to effectively treat pain. Most people, including policymakers, don't realize how many people are desperate to have their pain treated.”

About two-thirds of the ER visits related to misuse or abuse involved tramadol that was taken with other opioid pain relievers or anti-anxiety drugs (benzodiazepines). When tramadol is combined with other drugs that depress the central nervous system its sedative effects can be enhanced, causing seizures and a potentially fatal drug reaction known as serotonin syndrome.

Women were far more likely to have a tramadol-related trip to the ER than men, according to SAMHSA.

The greatest increase in tramadol-related misuse or abuse occurred in patients aged 55 and older. A SAMHSA spokesman said the higher number of older adults was not surprising because seniors are more likely to combine tramadol with other medication.

"Tramadol and other pain relievers can help to alleviate pain, but they must be used carefully and in close consultation with a physician," said SAMHSA Chief Medical Officer Elinore McCance-Katz, MD. "Like all medications tramadol can cause adverse reactions, which can be even more severe if the drug is misused. We must all work to lower the risks of taking prescription drugs.”

'Robust Response' to National Pain Strategy

By Pat Anson, Editor

Public reaction to the National Pain Strategy has been “very robust” according to the co-chair of the government committee that released a draft version of the report in early April.

Today marks the deadline for public comments on the 72-page report, a long awaited study that calls chronic pain a threat to public health, and identifies several areas where physicians and the healthcare system are failing pain sufferers.

“I think it’s safe to say that there was a very robust response,” said Linda Porter, PhD, co-chair of the National Institutes of Health’s Interagency Pain Research Coordinating Committee (IPRCC).

“I feel  like we really got the word out widely and the comments are coming in from a very broad range of the community, ranging from the professional societies, individual patients, coalitions of patients that have come together, and patient advocacy. So yes, I’m comfortable with it. We’ve gotten a good range of comments from a really broad set of folks.”

Some pain patients and advocates have complained that the IPRCC was dominated by academic researchers, physicians and government bureaucrats – and not enough input was sought from pain sufferers during the drafting of the National Pain Strategy (NPS).

“The NPS is essentially an underpowered, unrealistic, and undemocratic occupational strategy of some pain experts and professionalized lay experts, who were chosen because of their ideology and rank in certain organizations and government,” wrote patient advocate David Becker in his public comment on the NPS.

“There is no evidence that a survey or needs assessment of what Americans want from pain care was done or considered by the NPS and the NPS fails to make a case for their ‘evidence based, high quality, interdisciplinary, integrated multimodal biopsychosocial model’ as being what people in pain actually want out of pain care -- and especially those Americans in pain who will be forced to live with a plan they had no say in developing.”

Porter said she could not release the number of comments that have come in during the public comment period, but she was satisfied patients had a voice in drafting the National Pain Strategy.

“We felt very strongly that their voice had to be heard,” Porter told Pain News Network. “We had patients and patient advocates on every single one of the work groups, on the oversight panel, and on the IPRCC. There was actually a large group of patient advocates and we made sure that each of the working groups had at least a voice on it and some of them had several.”

A list of members on the IPRCC’s oversight committee can be found here. Two of the panel’s 14 members are pain sufferers and/or patient advocates. The rest are longtime experts in the field of pain management, including several who helped write the 2011 Institute of Medicine report, “Relieving Pain in America,” which estimated that 100 million Americans suffer from chronic pain.

Implementing the Plan

One member of the oversight committee said he found it “really exciting in terms of changing the culture of pain,” but admitted there were “minor things” about the NPS that bothered him.

“There is nothing in it about pediatric pain. There’s not as much emphasis on research as we would always like, particularly basic science is left out of it,” said Greg Terman, MD, an anesthesiologist and professor at the University of Washington who is president of the American Pain Society.

“The general problem that I had as a member of the oversight committee is how are we going to implement any of the recommendations? And the answer is I don’t think anyone knows yet, it’s not even final. But I am optimistic.”

The NPS calls for significant improvement in pain management practices, including better education in pain care for physicians, more collaboration between primary care physicians and pain specialists, broader insurance coverage of pain treatments, and more research. But nowhere in the report is the cost for any of the recommendations even discussed.

“That was not our responsibility nor did we have the ability to estimate what these would cost,” says Linda Porter. “It was really out of our scope and we were not asked to do that. It will certainly come up in the planning stage.”

Porter said cost estimates will be handled by the federal Department of Health and Human Services, which is still in the “discussion and planning stage” of deciding which recommendations to implement first. She expects a plan to be announced in late summer or early fall of this year.

“Things move slowly in government I hear,” says Terman. “It’s there, at least in writing, what needs to be done from our expert opinion. Having it gathered all in one area has never been done before and maybe if we can’t make it happen in the next year, maybe in a few more years. If it’s still sitting there waiting to be implemented, sadly there will still be patients waiting to be helped.”

Why Doctors Are Slow to Embrace Medical Marijuana

By Pat Anson, Editor

Public attitudes toward marijuana have changed considerably in recent years. Voters and legislators in 23 states and the District of Columbia have legalized medical marijuana, and nationwide polls show that most Americans now support legalization.

But the nation’s medical organizations – while intrigued about the potential for marijuana to treat conditions like chronic pain – have been slow to embrace cannabis. And most doctors still refuse to prescribe it, even in states where marijuana is legal.

Those conflicting attitudes were on display last week at the annual meeting of the American Pain Society (APS) in Palm Springs, California – a conference focused on pain research. Although the APS has no stated policy on marijuana, the organization chose as its keynote speaker one of the most prominent medical marijuana researchers in the world, Dr. Mark Ware.

“I’ve done presentations and sessions, and it always surprises people how much interest there is,” said Ware, who is a family physician and associate professor in Family Medicine and Anesthesia at McGill University in Montreal.

“Cannabis gives people a window to come and learn, and while they’re learning about medical cannabis they can be learning about pain management and other things. It’s a very useful magnet to get people interested in a topic that’s obviously of enormous public importance.”

DR. MARK WARE SPEAKING AT THE APS CONFERENCE

Ware’s two presentations at the APS conference were well-attended, but it was mostly researchers – not practicing physicians – who were listening.

“A lot of doctors are afraid to authorize it (marijuana) because they’re afraid of losing their licenses and their practices. So there’s a lot of fear and a lot of stigma,” Ware told Pain News Network.

“I think the researchers themselves are seeing opportunities, with changing state laws and increasing evidence of efficacy, that suddenly this is becoming a drug that can be taken a bit more seriously. And I think that’s giving rise to the opportunity that maybe there’s some work we can be doing here.”

Federal laws making marijuana illegal – which are still in effect – have stymied serious research into its medical benefits. Most of the evidence so far is anecdotal or the result of small academic studies – not the in-depth and expensive clinical research that pharmaceutical companies have to conduct to get FDA approval for their drugs.

“There’s still work to be done on the safety and efficacy of these cannabinoid compounds,” says Gregory Terman, MD, an anesthesiologist who is president of the APS.  “They’re very interesting molecules. But they’re not approved for people and we don’t want to pretend they’re anywhere near ready for prime time.”

The APS currently has a committee working on a policy statement about medical marijuana.

“I think people are opening their eyes to the possibility,” said Terman. “Marijuana’s already out there, and that’s why we felt like it was important to work on a policy statement.”

The American Academy of Pain Management (AAPM) also doesn’t have a formal position on marijuana – although some members are urging the organization to take one.

“I think there’s no doubt there are substances in there that can be beneficial to some people with pain. It’s just a question of figuring out what they are and how do you get them extracted in a way so that we know what we’re giving people,” said Bob Twillman, PhD, executive director of the AAPM. “We haven’t settled on a policy because there are so many different variables and so much is up in the air that coming up with a good policy is hard to do.”

Twillman says he is being lobbied by some AAPM members to advocate for the rescheduling of marijuana from an illegal Schedule I controlled substance – the same classification the DEA has for heroin and LSD – to a Schedule II medication that can be prescribed to patients.

“I don’t think you can do that with a product like this because every batch is different. How do you standardize the dose that a patient is given? I think in a regulatory scheme of things it’s more like an herbal supplement than it is a drug,” Twillman told Pain News Network.

The American Medical Association, the nation’s largest medical group, has moderated its position on marijuana – from one of strict opposition to a grudging call for more research.

“Our AMA calls for further adequate and well-controlled studies of marijuana and related cannabinoids in patients who have serious conditions for which preclinical, anecdotal, or controlled evidence suggests possible efficacy,” the AMA says in a policy statement.

“This should not be viewed as an endorsement of state-based medical cannabis programs, the legalization of marijuana, or that scientific evidence on the therapeutic use of cannabis meets the current standards for a prescription drug product.”

Until that research is done and federal laws change – which could take years – many practicing physicians are unlikely to endorse or prescribe a drug that is still technically illegal.

“I think there’s still this stigma and the lack of data and concerns about safety that will always plague that discussion as long as we don’t have it,” says Mark Ware.  “So I think there will be clinicians who will be early adopters who take this a bit more seriously and there will be others who will be almost religiously opposed to the idea. And I hope that starts to breakdown.”

Using Marijuana and Opioids Doesn't Raise Risk of Abuse

By Pat Anson, Editor

As more and more states legalize medical marijuana, many chronic pain patients are turning to cannabis for pain relief. Some are also continuing to use opioid pain medication – raising concern that the combination could increase their risk of substance abuse.

But a new study at the University of Michigan found that patients who use marijuana and opioids are not at higher risk for alcohol and drug abuse. Researchers studied 273 patients at a marijuana clinic in Michigan and found that more than 60% were also using prescription opioids.

"We expected that persons receiving both cannabis and prescription opioids would have greater levels of involvement with alcohol and other drugs," said Brian Perron, PhD, of the School of Social Work at the University of Michigan.

"However, that wasn't the case -- although persons who were receiving both medical cannabis and prescription opioids reported higher levels of pain, they showed very few differences in their use of alcohol and other drugs compared to those receiving medical cannabis only."

Participants in the study, which is being published in the Journal of Studies on Alcohol and Drugs, did report higher rates of drug use than the general population. But their use of other drugs -- including alcohol, cocaine, sedatives, heroin, and amphetamines – was similar whether they used opioids or not.

“I am thrilled this research is now happening so others will also gain the confidence in trying medical marijuana,” said Ellen Lenox Smith, a medical marijuana advocate and columnist for Pain News Network.

“People who have addictive personalities will have issues weather it is alcohol, marijuana, smoking, or opioids. Those of us without that tendency do not have to be concerned. We have patients that have been using both medications successfully, but most of them have eventually chosen to wean away from the opioids due to the annoying side effects. But while using both, they have seemed to cope fine and metabolize both.”

A noted medical marijuana researcher says cannabis may actually make opioids more effective – enabling some patients to take lower doses.

“We’ve seen it in patients who started using cannabis successfully and they were able to reduce their other medications,” said Mark Ware, MD, an associate professor in Family Medicine and Anesthesia at McGill University in Montreal.

“In some cases they find that the dose of opioids that they were taking, they can lower it and get a similar effect at much lower doses. In others, they don’t need the opioids any longer and they’re able to taper off and stop it completely.”

Ware and other researchers believe medical marijuana may be a safer alternative to opioids, which have a higher risk of addiction and overdose. But they stress that communication between doctors and patients is important – since some doctors may have no idea if a patient is using marijuana.

"Physicians do not actually 'prescribe' medical cannabis -- they only certify whether the patient has a qualifying condition, which allows the patient to gain access to medical cannabis,” said Perron.

“The system of dispensing medical cannabis is completely separate from prescription medications, so physicians may not know whether a given patient is using medical cannabis, how much, and in what form."

FDA Approves Migraine Drug for Children

By Pat Anson, Editor 

Millions of children who suffer from migraine headaches have a new treatment option -- an old drug that's already available to adults. 

The Food and Drug Administration approved Treximet for pediatric patients 12 years of age and older for the treatment of migraine with or without aura. Treximet is the first approved combination prescription drug for migraine to contain sumatriptan and naproxen, a non-steroidal anti-inflammatory drug (NSAID). Sumatriptan is a triptan that works in the brain by reducing vascular inflammation. 

About 20 percent of all pediatric patients 11 years and older suffer from migraine, but treatment options have been limited, compared to adults. 

“Until now, pediatric migraine sufferers have not had the same number of treatment options compared to adults to manage the potentially debilitating effects of acute migraine,” said Merle Lea Diamond, MD, president and managing director of the Diamond Headache Clinic and a consultant to Pernix Therapeutics (NASDAQ: PTX), which developed Treximet. Pernix expects Treximet to be available for pediatric patients in the third quarter of 2015.  

“As many as one out of five teens suffers from migraines, and their burden goes well beyond the pain, as migraines can also adversely affect their social growth and their efforts in school,” said Diamond. 

FDA approval came after a Phase III safety and efficacy study that found Treximet was significantly more effective than placebo in treating migraine in pediatric patients and has a safety profile similar to that of Treximet for adults. It comes with a black box warning of cardiovascular and gastrointestinal risks. 

The FDA approved Treximet for adults in 2008. The FDA set a priority review of Treximet for pediatric patients, in part, on the need for more treatment options for younger migraine sufferers.  

Amgen Migraine Drug 

Meanwhile, Amgen (NASDAQ: AMGN) announced the first results from a Phase II study evaluating the efficacy and safety of AMG 334 for the prevention of episodic migraine.

The  company said the study met its primary goal of reducing monthly mean migraine days compared with placebo.  The data were presented at the International Headache Society in Valencia, Spain.

AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine by inhibiting a peptide receptor that is believed to transmit signals that can cause incapacitating pain.  

In the trial, 483 patients who averaged 8.7 migraine days per month prior to the study had their number of migraine days nearly cut in half by taking AMG 334.

"Migraine is a complicated, underdiagnosed neurological condition that has significant impact on the everyday activities of those who live with it, and for the millions of people around the world who are affected by this disease, significant unmet therapeutic need persists," said Sean Harper, MD, executive vice president, Research and Development at Amgen. "We are encouraged by these Phase 2 data, which further validate AMG 334 as a potential preventive treatment for episodic migraine."

Migraine is thought to affect a billion people worldwide and about 31 million Americans adults. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

CDC Social Media Campaign Backfires

By Pat Anson, Editor

A social media campaign by the Centers for Disease Control aimed at raising awareness about the  "epidemic" of painkiller abuse had the unintended effect of launching another campaign about the "pandemic" of untreated chronic pain -- and how the agency was failing to address it.

Last month the CDC encouraged people to "help us tell stories of the many people whose lives have been affected by prescription painkiller addiction or the death of a loved one."

The agency, which estimates that over 16,000 Americans die annually from painkiller overdoses, asked for stories to be posted on Facebook, Instagram and Twitter with the hashtag #RxProblem.

“Prescription drug overdose devastates individuals, families and communities,” said Erin Connelly, associate director for Communication at the CDC. “We’d like to get everyone talking and thinking about the risks involved with opioid painkillers.”

While painkiller addiction and overdoses are undoubtedly a public health issue, the #RxProblem campaign rubbed some activists in the pain community the wrong way.

"There are really two problems with prescription drugs. One is the problem of abuse. But the other problem is patients who have pain and have a legitimate medical need for these drugs and can't access them," said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

"I think they (the CDC) know what the problems are, but for some reason they don't want to deal with the chronic pain problem. I've criticized them for calling the problem of prescription drug overdoses and prescription drug abuse an 'epidemic' and taking a much, much bigger problem like chronic pain and not saying anything about it.  Because to me, if 16,000 people a year dying from overdoses is an epidemic, then 100  million people with chronic pain must be a pandemic."

It was Twillman's idea to launch a rival social media campaign to draw more attention to the chronic pain problem.

"What we came up with was the idea of the hashtag #AnotherRxProblem, and have people who have trouble getting their medications write in about that experience and the impact that's had on them," Twillman told Pain News Network.

Write in they did, with hundreds of people complaining about the one-sided approach the CDC was taking to prescription pain medication.

"We need to live a quality life. Don't punish us. Find better pain control," posted Teri Daniel on Twitter.

"When will we take untreated pain seriously?" asked Melissa VanHouten.

"We have 2 public health crises: RxDrugAbuse & UnrelievedPain. Stop blaming. Work together," wrote Barby Ingle.

"We got a tremendous response. If you look at the Twitter feed for #RxProblem, about half of the posts are #AnotherRxProblem posts. We started another campaign on Facebook and the Facebook response absolutely blew up," said Twillman.

Dozens of pain patients also shared their stories on Dr. Jeffrey Fudin's blog.

"I’m going to get right to the point. PAIN AND OPIOIDS. They do help us. Yes, they’re in every group abusers and non-abusers. Those that it helps for medical necessity should not have to be punished, denied, etc. for those who choose to disregard the contract they signed," wrote Gina. "CDC there are alternatives, to wean out drug abusers. Utilize the resources you have vs. taking the easy way and punishing all."

The CDC's #RxProblem campaign officially ended May 15th. Did they get the message from #AnotherRxProblem get through?

"I'm not optimistic that it's going to make a change in what they're doing. But if it raises someone's awareness, then it was worth it," said Twillman. 

Hillary Clinton: Please Be Responsible for Opioids

By Lynn R. Webster, MD

While Presidential candidate Hillary Clinton only recently announced her bid for office in 2016, she has already declared a few important issues on her presidential agenda, including the ever-important opioid crisis in the United States.

Many are chiming in to offer their best solutions to curbing the opioid abuse epidemic; sadly, many of the proposed solutions fail to promote and fund safer alternative therapies for people suffering from chronic pain who rely on opioids to live a semblance of a normal life.

I applaud Clinton’s desire to work toward a safer, opioid-free world. It’s a goal we should all aspire to. In order to realize it, however, we must not forget those people who rely on opioids to get through the day in the absence of alternative treatments.

Here is what Hillary Clinton must consider as she seeks to curb opioid abuse:

Redefine the prescription opioid problem as the chronic pain problem

Prescription opioids have garnered a great deal of attention for the possible health risks involved in taking the drug. While it is easy to get caught up in the whirlwind of bad press, it is still important to remember why opioids are such a prominent treatment form in the first place.

More than 100 million people in the United States suffer from chronic pain, meaning a third of the entire country may rely on some form of medication to make their lives better. Pain ranges in severity, with many suffering from severe pain that makes it difficult to live a normal life.

While no medical professional advocates that opioids should be the first line of defense, in some cases, they happen to be the only thing that works for a patient. Trying to end opioid abuse without addressing the needs of those who rely on the drug may make the problem of chronic pain worse.

Understand why prescription opioids have risen in popularity

In 2007, Americans spent $34 billion in out of pocket expenses to cover the cost of alternative forms chronic pain treatment.  To be clear, opioids are not the only means of treating chronic pain. Alternative therapies exist, but are woefully underfunded by payers. As a result, many patients with severe chronic pain, those who struggle to get out of bed, who sometimes lose their jobs, must rely only on what their insurance covers – in most cases, that form of treatment is opioids.

The chronic pain community needs access to safer alternative therapies. We need to invest in research to bring even more alternative therapies to the market, and crucially, insurance companies must then cover those alternative forms of care.

In 2012 the National Institutes of Health (NIH) spent only about 400 million dollars on chronic pain conditions but more than 2.5 billion dollars was spent on drug and other substance research.  We certainly need to find safer and more effective therapies for addiction but some of the current cost associated with substance abuse it due to the limited options to treat the number one public health problem in America: pain.

Stop stigmatizing patients who currently rely on opioids

Alternative forms of medication that could potentially help chronic pain patients and decrease the demand for opioids remain underfunded and under-researched. Despite being one of the largest health researchers and sponsored by the U.S. Department of Health and Human Services (HHS), the NIH continues to operate on a shoestring budget.

Despite the lack of options for alternative therapies for chronic pain, the topic of opioid abuse has become a popular topic in the media, and sadly, caused an increase in stigmatization of patients who use opioids for pain management. Patients have reported reluctant doctors and pharmacists unwilling to prescribe necessary medications.

The DEA has rescheduled hydrocodone as a Schedule II drug, leading to a series of unintended consequences with which patients today are left to suffer. Many patients report feeling like drug addicts for simply trying to fill their legally obtained prescriptions.

Require all opioids to be abuse-deterrent

Abuse deterrent formulations (ADF) have been shown to curb some forms of opioid abuse, while maintaining the benefits for patients that need the drug.  Unfortunately payers have priced these safer formulations so that there is little incentive for market adoption.  HHS should lead the way and negotiate deals with manufactures to make ADFs no more expensive than generic alternatives to patients.

Remove methadone as a “preferred” drug

While the use of methadone as an analgesic for chronic pain has expanded in recent years, it shows up in mortality reports with a higher frequency than other opioids. Despite the evident risk associated with this drug, many states have listed it as a “preferred” analgesic in treating severe chronic pain, largely due to its low cost and savings for publicly funded health plans.

The American Academy of Pain Medicine holds that methadone should not be a preferred drug unless special education is provided, and that it should never be the first choice in treating chronic pain.

The opioid crisis is not a black and white issue. Until we stop treating it as such, we will not be able to tackle the problem at its root. Eliminating opioids does not alleviate the problem, end patient suffering or acknowledge what the true issue is. Millions of Americans suffer from chronic pain, but very few have access to multiple options to manage their pain.

Through an increase in funding and research of alternative therapies, implementation of ADF’s and greater coverage by payers, we can finally begin to treat the opioid epidemic in a safe and responsible way – a way that does not hurt the millions of Americans who rely on opioids to get out of bed, to play with their children, to get through the day.

Lynn R. Webster, MD, is Past President of the American Academy of Pain Medicine, and vice president of scientific affairs at PRA Health Sciences. He is a Pain Medicine News editorial board member and author of a forthcoming book, “The Painful Truth.” He lives in Salt Lake City. Follow him on Twitter @LynnRWebsterMD, Facebook and LinkedIn.

This column is republished with permission from Dr. Webster’s blog.

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.

Study: Painkiller Abuse Costs Employers $25 Billion

By Pat Anson, Editor

Painkiller abuse is costing U.S. employers over $25 billion a year in lost productivity and missed work days, according to a new analysis by a healthcare consulting firm that also found that the vast majority of patients who are prescribed opioids do not have an abuse problem.

The “white paper” was produced by Healthentic, a Seattle-based company that helps employers identify health savings to reduce the cost of employee healthcare. You can download a copy of the report, called “Painkiller Abuse Is Costing Your Company” by clicking here.

"Opioid misuse costs employers in multiple ways including more medical costs and productivity loss," said Jeff O'Mara, CEO of Healthentic. "Employers have a unique opportunity to help people get more productivity for less money by identifying and engaging the people at risk."

Healthentic reviewed four years of health insurance claims data from 2011 to 2014 and found that only a small percentage of pain patients were misusing or abusing opioids.

"It was remarkably consistent that most people with an opioid prescription do not have a chronic or abuse problem. In fact, 87% of those prescribed an opioid in those four years didn’t show a cause for concern in the claims data,” the report states.

And what about the other 13 percent?

Healthentic identified three red flags in those patients that raised potential cause for concern:

1. Ten or more opioid prescriptions
2. A prescribed opioid supply for 120 days or more
3. A week or more of overlapping prescriptions for opioids and benzodiazepine, a sedative used to treat anxiety, depression and insomnia

“These people – just 13% -- are responsible for 92% of employer’s costs. And if you break it down even further, the 7% of the population with an opioid prescription that have two or more issues account for over 80% of the cost,” the report states.

Healthentic said opioid abusers used significantly more healthcare resources than non-opioid users, and cited a study that estimated the cost of their healthcare at $10,627 annually. In addition, opioid abusers cost employers $1,244 more in lost work days compared to non-abusers.

The company advised employers that opioids “should not be the first line of treatment” for back pain and other common workplace injuries, and said over-the-counter pain relievers like Tylenol and ibuprofen are “a more affordable and safer option.”

Healthentic recommended four actions to employers to address opioid abuse:

1. Understand and insist upon conservative prescribing guidelines for pain treatment for all participating providers.
2. Evaluate and know which employees are at risk by reviewing their insurance claims.
3. Educate employees about the risks of opioid drug use.
4. Increase and ensure access to treatment programs for employees with an abuse problem.

"Our hope is this analysis provides further insight into the societal and financial issue of prescription painkillers, and helps employers take strides in alleviating the problem to ensure the well-being of their people," said O'Mara.

Healthentic provides healthcare data and analytic services to nearly 11,000 corporate clients in 19 states.

Researchers Develop New Painkiller from Lidocaine

By Pat Anson, Editor

A fast acting pain reliever widely used to treat everything from itching to dental pain could be developed into a new medication that offers longer lasting pain relief.

"Because of its versatility and effectiveness at quickly numbing pain in targeted areas, lidocaine has been the gold standard in local anesthetics for more than 50 years," said George Kracke, PhD, an associate professor of anesthesiology and perioperative medicine at the University of Missouri (MU) School of Medicine.

"While lidocaine is effective as a short-term painkiller, its effects wear off quickly. We developed a new compound that can quickly provide longer lasting relief. This type of painkiller could be beneficial in treating sports injuries or in joint replacement procedures."

Lidocaine is used as an injectable pain reliever for minor surgical or dental procedures, and as an over-the-counter ointment or spray to relieve itching, burning and pain from shingles, sunburns, and insect bites.

The new compound -- called boronicaine -- could potentially serve many of those same functions as an injectable or topical painkiller.  

MU researchers synthesized boronicaine as a derivative of lidocaine by changing its chemical structure. They found that boronicaine provided pain relief that lasted five times longer than lidocaine. In pre-clinical, early stage studies, boronicaine provided about 25 minutes of relief, compared to about five minutes of pain relief with lidocaine.

"Although some conditions may warrant the use of a short-lasting painkiller, in many cases a longer lasting anesthetic is a better option," said Kracke, who is lead author of a study published in the chemistry journal ChemMedChem . "Having a longer lasting anesthetic reduces the dosage or number of doses needed, limiting the potential for adverse side effects."

Other types of short term analgesics provide longer pain relief than lidocaine, but they also have side effects they can cause heart toxicity and gastrointestinal problems. Preliminary findings show no toxicity in single-dose studies of boronicaine, though more studies are needed.

"Boronicaine could have distinct advantages over existing painkilling medications," said M. Frederick Hawthorne, PhD, director of MU's International Institute of Nano and Molecular Medicine and a pioneer in the field of boron chemistry. "We're conducting more research into the side effects of the compound, but in time it could very well become a useful material to use as an anesthetic."

Survey: Most Pain Patients Don't Abuse Painkillers

By Pat Anson, Editor

Only a small percentage of chronic pain patients misuse or abuse their opioid painkillers, according to a wide ranging survey by the Partnership for Drug-Free Kids that also found a “disconnect” between patients and their doctors about opioid prescribing.

About one in ten pain patients (7% of chronic pain patients and 13% of acute pain patients) admitted misusing their opioid medications. Nearly half took longer to finish their prescriptions than directed – which was usually an effort to save the pain medication for another time.

More than one in ten (13% of chronic pain patients and 15% of acute pain patients) admitted using someone else's opiate prescription.

The online survey of 705 pain patients and 360 prescribing physicians was conducted by the research firm Whitman Insight Strategies (WINS) earlier this year.

About two-thirds of the opioid prescribers said they “always” warned their patients about the risk of addiction and dependency.

But when patients were asked who, if anyone, explained to them the potential for becoming dependent or addicted to painkillers, 19% of chronic pain patients and 40% of acute pain patients said "no one."

The survey also found that most patients pay little attention to the proper storage and disposal of pain medication. Only 11% of chronic pain patients and 13% of acute pain patients said they were concerned that someone else in their household might use their medications.

Less than half of chronic pain patients (42%) who have children said they store their medication somewhere their kids can’t reach. Most patients said their doctors never discussed the proper storage and disposal of painkillers.

"This research highlights key opportunities for prescribers of Rx opiates and their patients to have better communication around proper use and disposal of prescribed painkillers," said Marcia Lee Taylor, Interim President and CEO of the Partnership for Drug-Free Kids.

"The Centers for Disease Control has deemed abuse of prescription painkillers an 'epidemic,' and we can all do our part to help turn the tide on this critical health issue. Prescribers and patients can become more aware of the repercussions surrounding the improper storage and disposal of Rx pain medications and talk more at length in order to improve doctor-patient communication and help curb abuse."

The survey also found that many physicians are concerned about patients misusing their pain medication – by either taking too little or taking too much.

The majority of prescribers (77% of primary care physicians and 75% of pain management specialists) believe their patients do not always use their prescribed opiates in accordance with instructions. Twenty percent of the primary care physicians said they don’t feel comfortable prescribing opiates at all.

"This research suggests to us that prescribers need to feel more confident in assessing the potential risk of misuse or abuse of the Rx medicines, but unfortunately many of them feel they have not received proper training to assess those risks. There is a lot more we can do to help prescribers feel they have the proper tools they need to feel comfortable prescribing these medicines and taking action if a patient is abusing them," Taylor said.

The survey also found that most pain patients would prefer alternatives to opioids. About 9 in 10 chronic pain patients have tried an alternative treatment such as physical therapy and massage. Many were hindered in their use of alternative therapies by restrictions on insurance coverage.

Why You Should Consider Medical Marijuana

(Editor’s note: Pain News Network is pleased to welcome Ellen Lenox Smith as our newest columnist. Ellen has suffered from chronic pain all of her life, but it wasn’t until a few years ago that she discovered the pain relieving benefits of medical marijuana. In future columns, Ellen will focus on marijuana and how it can be used as pain medication. Medical marijuana is legal in 23 U.S. states and the District of Columbia. But even in states where it is legal, doctors may frown upon marijuana and drop patients from their practice for using it.)

By Ellen Lenox Smith, Columnist

Why -- at the age of 57 -- would one ever consider turning to medical marijuana? 

I wondered the same thing after being sent to a pain doctor just before another surgery in 2006. After reviewing my records and seeing that I was unresponsive to pain medication, the doctor clearly had no idea what to suggest, except trying medical marijuana. 

I was born with Ehlers Danlos syndrome and later also added sarcoidosis to my life. I was living with chronic pain that was preventing me from sleeping, thinking straight, and functioning.

From birth, I had one issue after another reacting to medications. And after 22 surgeries, you can imagine the horror of all I had to endure and the added pain of never knowing the proper relief my body could have from pain medication. Eventually, a DNA drug sensitivity test was ordered and it confirmed I could not metabolize most drugs. This meant no aspirin, Tylenol, or any opiates. 

I took the advice to try medical marijuana with tremendous trepidation. At that time in Rhode Island, you either had to grow your own or buy it on the black market.  Since growing takes about three months, I decided the only way to find out what marijuana would do for me was to find a source and give it a try. 

ELLEN LENOX SMITH

When I was able to find some marijuana, I ground it up, heated up some olive oil and let it release the medicine into the oil. I had no choice, since I was told by a pulmonologist that smoking marijuana with sarcoidosis in the chest would be fatal. I wanted to try a different way to administer it.

That night, I measured out one teaspoon of the infused oil. I mixed it with some applesauce and one hour before bedtime, I swallowed it down. I remember being scared -- for I am not one that likes to be out of control of my body. Having smoked marijuana once in college, I hated that sensation. 

As soon as I took the dose, I went to my husband and warned him that I had taken marijuana and to keep an eye out for me. I was convinced this was a stupid thing to be doing and I would be stoned all night.

One hour later, we got in bed, I closed my eyes and before I knew it, it was morning. I had slept the whole night, never waking up once!

I woke up refreshed, not groggy, and ready to take on life again. I had no “high” or stoned sensation like you would guess would happen. 

I learned quickly that someone in pain does not react the same way to cannabis as someone who uses it for recreational reasons. The brain receptors connect with the THC and cannabinoids (the active ingredients in marijuana), and provide safe and gentle pain relief.

I was shocked and thrilled with the result. My husband and I quickly got to work setting up a legal way to grow marijuana. I realized that life was directing us to new topic we just had to advocate for. 

If I was scared to try marijuana, there is no question that others felt the same way -- and we had to let them know how amazing it really is. Society brought us up to be negative about marijuana, yet it was used in our country many years ago and even sold in pharmacies. The success of this medication was squashed, and we were all led to believe that it was bad and dangerous.

What we learned is that no one dies from using marijuana, no one develops organ damage, and with a body in chronic pain -- you can regain your life back. 

Are my conditions cured? No, they are both incurable. But I have been able to advocate, think, feel and live again thanks to using medical marijuana. 

Don’t be scared. Consider how much safer this medication is than all the other pain relief choices out there. Turn your body and your life with pain around. You won’t regret it.

Ellen Lenox Smith 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. 

If you have a question for Ellen about medical marijuana, leave a comment below or send it 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.

Doctor Defends Use of Urine Drug Tests

By Pat Anson, Editor

A prominent pain doctor is disputing reports that a widely used urine drug test often gives faulty results.

“They are reasonably reliable and highly cost effective for use in a pain management practice. I would strongly recommend the practitioners use this,” said Laxmaiah Manchikanti, MD, chairman and CEO of the American Society of Interventional Pain Physicians.

Dr. LAXMAIAH MANCHIKANTI

Dr. Manchikanti, who is medical director of a pain clinic in Paducah, Kentucky, was the lead author of a study published in the journal Pain Physician in 2011, which looked at the reliability of immunoassay “point-of-care” (POC) tests. The urine tests are inexpensive and give immediate results, and doctors often use them to monitor their patients for opioid or illicit drug use.

“The UDT (urine drug test) with immunoassay in an office setting is appropriate, convenient and cost effective. Compared with laboratory testing for opioids and illicit drugs, immunoassay office testing had high specificity and agreement,” Manchikanti's study found.

Pain News Network recently reported on the results of a second study conducted by Millennium Health, a San Diego-based drug testing laboratory, which found that POC tests were wrong about half the time – frequently giving false positive and false negatives results for drugs like marijuana and oxycodone. The Millennium study advocates the use of chromatography-mass-spectrometry – a more complex laboratory test that costs thousands of dollars – to confirm POC test results.

“Following the advice from companies in reference to numerous expensive tests and also income generating avenues will only lead to time in the slammer and will not improve patient care at all,” said Manchikanti.

“(The) Millennium study is performed by the company which makes a living by testing. The more samples that are sent to them, the better off they are. Further, they are not even a practical setting. From our practice we send approximately only 2% of the samples for confirmation testing. Even then, the patients can’t pay their bills.”

Manchikanti’s study found false negative and false positive rates for POC tests that were far below the rates reported by Millennium.

For example, Millennium’s false positive rate for oxycodone was 41.3 percent. For Manchikanti, it was only 7.7 percent.

Millennium’s false positive rate for marijuana was 21.3 percent. For Manchikanti, it was just 2 percent.

There were discrepancies between the two studies for several other drugs, including methadone, cocaine and methamphetamine.

Millennium Sponsored Both Studies

How could two studies come to such different conclusions?

There were some differences in their design. Urine samples in the Millennium study came from nearly 4,300 patients in addiction treatment clinics, while the urine samples in Manchikanti’s study came from 1,000 patients in pain management programs. Millennium maintains the patients in its study were younger and more likely to be drug users.

Ironically, the laboratory tests for both studies were conducted by Millennium – which collected samples and provided chromatography-mass-spectrometry testing at no cost to Manchikanti. Millennium is identified as the “sponsor” of Manchikanti’s study, but he says the company had “no influence or interference” in his and his three co-authors’ findings.

“We had our agreement in the beginning itself that they will not be involved in any way in writing the manuscript or publishing the results. Consequently, they really did not have much input into the publication. The publication was as it is and without any bias from the industry,” Manchikanti wrote in an email to Pain News Network.

Millennium’s study, which was published last year in the Journal of Opioid Management, had six co-authors. All but one were employees of the company. The lone exception is a pain management doctor who frequently testifies as a legal expert for Millennium in court cases.

A source with broad experience in the drug testing industry told Pain News Network the data in Millennium’s study was “skewed toward exaggeration.”

“It does not surprise me that Millennium would show a high rate of inconsistencies with the POC test. Remember, their business is to sell confirmation testing, so they will skew the way they present data to try to influence the market to do more confirmation testing.  In most cases, that’s how it works in any study conducted or funded by a device or pharmaceutical company,” the source said.

Millennium bristles at the notion that its study was biased.

“Millennium Health strongly disagrees with the characterization… that the study was skewed or biased in any way,” the company said in a statement to Pain News Network.

“The study was accepted and published by a well-respected, peer-reviewed publication. Millennium Research Institute is committed to the highest ethical and research science standards, and we stand by the results of our study. The study was based on random samples from addiction treatment clients. The data clearly indicated that immunoassay, or point-of-care, tests have a high rate of false positives and false negatives when used to screen patients for illicit drug use.

“Millennium is committed to providing data that helps clinicians evaluate the best course of treatment for patients with pain and addiction issues. Millennium Health performs only the tests ordered by clinicians.”

In recent years a growing number of doctors who treat addicts and pain patients have required them to submit to drug tests. The competition between Millennium and other laboratories for this business is intense. According to one estimate, drug testing has grown into a lucrative $4 billion dollar a year industry.

But Manchikanti maintains that a single inexpensive urine test that costs about $20 is often the only one that’s needed.

“If a proper (patient) history is provided which matches with the test, there is no need for further testing,” he said.

FDA Order Stops Production of Medtronic Pain Pump

By Pat Anson, Editor

The U.S. Food and Drug Administration has filed a court order against medical device maker Medtronic ordering it to cease production and distribution of its SynchroMed II pain pumps.

Defects in the surgically implanted pumps, which are used to treat patients with chronic pain, cancer and severe muscle spasms, have been blamed for over a dozen deaths. The devices either lost power or inadvertently injected patients with too much or too little medication. The pump delivers analgesic drugs directly to the spinal fluid of pain patients.

Under the FDA's consent decree with Medtronic, the company will stop production of the SynchroMed II pump at its manufacturing plant in Columbia Heights, Minnesota. Medtronic will also retain a third-party expert to help develop and submit plans to the FDA to correct manufacturing and design problems. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions of the consent decree.

The FDA first approved the SynchroMed II pumps in 2004. Between 2006 and 2013, FDA investigators conducted five inspections at Medtronic’s production facilities, resulting in three warning letters notifying the company of major violations. The violations included inadequate processes for identifying quality control problems, failure to document design changes, and failure to ensure that finished products meet design specifications.

“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” said Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”

Over 200,000 SynchroMed pumps have been implanted worldwide, according to Medtronic, but the devices are not being recalled. Patients who experience a sudden change in their pain levels or hear a device alarm are being urged to contact their physician immediately.

“The agreement does not require the retrieval of any Medtronic products. With this announcement there is no new information to share about the safety and performance of the SynchroMed drug infusion system. Patients with the SynchroMed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement,” the company said in a statement.

"We are committed to the highest level of quality, and have pursued significant efforts in recent years to enhance the performance of the pump and to address the FDA`s expectations," said Tom Tefft, senior vice president and president of Neuromodulation, which is part of the Restorative Therapies Group at Medtronic.

Soaring Cost of Multiple Sclerosis Drugs 'Alarming'

By Pat Anson, Editor

The cost of drugs used to treat multiple sclerosis (MS) in the United States has soared as much as 700 percent in the past two decades, according to researchers who call the price escalation “alarming” and possibly coordinated by drug companies.

There are no multiple sclerosis drugs now available in the U.S. with a list price below $50,000 a year, which is two to three times more than the price of the same drugs in Canada, Australia or the United Kingdom. Prices of MS drugs rose at five to seven times the rate of drug inflation in the U.S.

“The coordinated price escalations for these therapies has lead to increasing access and affordability problems for patients with MS. Pricing decisions by pharmaceutical companies need to better reflect the financial realities and constraints of our healthcare system as opposed to a strategy of whatever our dysfunctional market will bear,” said Daniel Hartung, an associate professor in the Oregon State University/Oregon Health & Science University College of Pharmacy, in an email to Pain News Network.

Hartung is the lead author of a scathing new study appearing in the journal Neurology, which blames the soaring cost of MS drugs on the greed of drug companies and the inability of a national healthcare system to negotiate drug prices.

"The simplest explanation is that pharmaceutical companies raise prices of new and old MS disease modifying therapies in the United States to increase profits, and our healthcare system puts no limits on these increases," the researchers wrote in their report. "The U.S. Medicare program, the largest single-payer healthcare system in the U.S., is legally prohibited from negotiating drug prices directly with the pharmaceutical industry.

“Government-issued patent monopolies, third-party payers, lack of reimbursement transparency, and imperfect clinical information all contribute to a seemingly dysfunctional marketplace where expanded choice has led to higher, rather than lower, prices. Some argue that recent trends in industry pricing suggest collusive behavior between manufacturers, although this is challenging to prove with price data alone.”

Pricing Defies "Common Sense"

The researchers cite several examples of older MS drugs rising in price decades after they were approved by the Food and Drug Administration – and long after pharmaceutical companies recovered the cost of developing the medications.

The annual cost of Copaxone, for example, was $8,292 when it was introduced in 1996 by Teva Pharmaceuticals. Today it is $59,158 – over seven times higher.

Avonex, another early MS treatment, had an annual cost of $8,723 when it was introduced by Biogen in 1996. Today it is $62,394 – also seven times higher.

"Economics 101 would suggest that competition should lower prices. In the pharmaceutical industry we often don't see that. Many professionals now believe that it's time to push back, to say enough is enough," said Hartung.

“What has happened defies common sense, logic, and the expected rules of the marketplace,” wrote T. Jock Murray, MD, in an editorial about Hartung’s study also published in Neurology. “These counter-intuitive increases suggest the possibility of collusion among the manufacturers, but the authors say they do not have evidence.

“What justification does the pharmaceutical industry in the United States offer for the remarkable increase in the costs of these drugs? Well, they do not have to explain, as they are allowed to set prices in a black box, based on the business ethic of maximizing profit, supported by a bizarre law that prevents Medicare from negotiating prices directly with the pharmaceutical industry.”

“We cannot comment on the practices or products of other companies,” said Kate Niazi-Sai, a spokesperson for Biogen in an email to Pain News Network.

“What we can say is that since its introduction as one of the first MS therapies two decades ago, Avonex has helped many thousands of people with MS, who before then had no treatment options.  Since then revenue from Avonex has enabled the development of improved treatments so that today, patients have a breadth of options they need to deal with MS.”

Niazi-Sai said Biogen offers discount programs and free medicines to needy patients worth hundreds of millions of dollars each year. But that’s a fraction of what the company makes from MS drugs.

According to first quarter financial results released by Biogen, sales of Avonex and other MS therapies were $2.1 billion, compared to $1.7 billion in the same quarter last year.

Niazi-Sai said the money is put to good use.

“Revenue from our therapies for MS and hemophilia are now fueling the search for a way to reverse or possibly cure MS, as well as new treatments for Alzheimer’s disease, Lou Gehrig’s disease and other devastating medical conditions.  We are eager to be part of any thoughtful discussion about funding medical advances. Anyone who believes there is a better way should propose it," she wrote.

Teva Pharmaceuticals declined to comment on its pricing policies, but said in a statement to Pain News Network that “the wholesale acquisition cost for Copaxone is competitive to other branded molecules in this category. It is reflective of investments made to research, develop and commercialize a safe and effective relapsing MS product.”

MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain.

Escalating costs for MS therapies and other specialty drugs are a growing concern in the healthcare industry. A recent study said the cost of treating rheumatoid arthritis with new biologic drugs has become a “significant financial burden” for many patients. Patients enrolled in Medicare Part D plans paid an average out-of-pocket cost of $835 a month for a biologic drug in 2013. Costs varied widely depending on the drug – from $269 to $2,993 a month.

"Pricing in the pharmaceutical industry increasingly is a case of whatever the market will bear," Hartung said. "We used to think that any drug with $1 billion in sales was a blockbuster, but last year a drug for hepatitis C had 10 times that, or $10 billion in sales. This does not necessarily mean that drug research and innovation will be 10 times better.”

Weird Mushroom Could Lead to New Painkillers

By Pat Anson, Editor

A creepy looking parasitic mushroom that lives on caterpillars could help British researchers develop a new class of painkillers to treat osteoarthritis and other chronic pain conditions.

Scientists at the University of Nottingham are exploring the painkilling potential of cordycepin, a compound found in cordyceps mushrooms, which have been used in traditional Chinese medicine for thousands of years.

The mushroom acts as a parasite in the larvae of ghost moths – growing inside the caterpillar until it eventually kills it. The stalk-like mushroom then grows out of the caterpillar’s mummified body.

Food pellets containing the compound were given to rats and mice to see if cordycepin could relieve pain from a joint injury. The results, according to researchers, were startling.

"When we first started investigating this compound it was frankly a bit of a long-shot and there was much skepticism from the scientific community," said Dr. Cornelia de Moor. "But we were stunned by the response from the pilot study, which showed that it was as effective as conventional painkillers in rats.

A CORDYCEPS MUSHROOM (LEFT) EMERGES FROM A DEAD CATERPILLAR

"This study is the first step in a potential drug development for a new class of drugs for osteoarthritis, although there are a number of hurdles we have to go through - necessarily so - before it gets nearer patients. To the best of our knowledge, cordycepin has never been tested as a lead compound for osteoarthritis pain."

Native Tibetan healers have used cordyceps mushrooms as a tonic to treat a wide variety of conditions. They claim it improves energy, appetite, stamina, libido, endurance, and sleeping.

Researchers believe cordycepin blocks the inflammatory process that cause pain in osteoarthritis, but does so in a way that is completely different than painkillers like corticosteroids and non-steroidal-anti-inflammatory drugs (NSAIDs) such as ibuprofen.  Still unclear is whether cordycepin acts on the knee joint or on the nerves that send pain signals from the knee to the spinal cord.

Until clinical trials can be held to test the safety and effectiveness of cordycepin – which could take years – de Moor warns against people experimenting with herbal products containing the cordyceps mushroom.

"The lack of quality control means that cordyceps preparations for sale in Europe rarely contain much cordycepin, and may contain other harmful compounds," said de Moor, who is also investigating cordycepin as a possible treatment for cancer.

"Dr de Moor's research is certainly novel, and we believe may hold promise as a future source of pain relief for people with osteoarthritis. There is currently a massive gap in available, effective, side-effect-free painkillers for the millions of people with arthritis who have to live with their pain every day, so new approaches are very much-needed,"  said Dr. Stephen Simpson, director of research at Arthritis Research UK, which is helping to fund de Moor’s research.

Osteoarthritis is a progressive joint disorder caused by painful inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine. The World Health Organization estimates that about 10% of men and 18% of women over age 60 have osteoarthritis.