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.

Cost of RA Drugs a 'Significant Financial Burden'

By Pat Anson, Editor

Over the last decade great strides have been made in the treatment of rheumatoid arthritis (RA), but the cost of treating the disease with new biologic drugs has become a “significant financial burden” for many patients.

According to a new study published in Arthritis & Rheumatology, RA patients enrolled in Medicare Part D plans paid an average out-of-pocket cost of $835 a month for a biologic disease modifying drug (DMARD) in 2013. Costs varied widely depending on the drug – from $269 a month for the biologic infliximab to $2,993 a month for anakinra.

Costs remained high because the vast majority of Part D plans required RA patients to pay about a third of the cost of DMARD drugs, rather than a fixed dollar co-pay amount. In addition, catastrophic coverage under Part D didn’t kick in until out-of-pocket costs reached $4,450, after which patients paid 5% of the cost of DMARD drugs.

The financial burden is too much for many patients. According to a previous study, 1 in 6 adults with RA decreased their medication because of cost.

"While specialty DMARDs have improved the lives of those with chronic diseases like RA, many patients face a growing and unacceptable financial burden for access to treatment," said lead author Jinoos Yazdany, MD, with the Division of Rheumatology at the University of California, San Francisco (UCSF).

"Rather than determining which drug is best for the patient, we find ourselves making treatment decisions based on whether patients can afford drugs.”  

Rheumatoid arthritis is a chronic and incurable autoimmune disease that causes pain and stiffness in joints. Until the late 1990s, one in three RA patients were permanently disabled within five years of disease onset. In recent years there has been significant improvement in RA treatment, with disease control now possible for many patients who receive DMARD therapy.

Treatment with DMARDs is now a standard component of care with costs for some of the newer drugs topping $20,000 annually. A recent report by GBI Research estimates that the U.S. market for RA treatment will increase from $6.4 billion in 2013 to $9.3 billion by 2020, driven in part by an increase in the number of patients with RA – which is expected to grow from 1.3 million Americans to 1.68 million by 2020.

The UCSF study analyzed Medicare Part D coverage of nine biologic medications (abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab) and nine non-biologic DMARDs (azathioprine, cuprimine, cyclophosphamide, cyclosporine, hydroxychloroquine, leflunomide, methotrexate, minocycline, and sulfasalazine).

Although nearly all Part D plans covered at least 1 biologic DMARD, access was tightly controlled, with 95% of plans requiring prior authorization.

Researchers said implementation of the Affordable Care Act (Obamacare) will not significantly lessen the cost of biologic drugs.

"Many patients are strapped with a substantial financial burden," said Yazdany. “Clinicians caring for individuals with RA should be aware of this and be prepared to discuss long-term affordability as well as relative efficacy of biologic DMARDs with their patients to help them make informed decisions about treatment. Currently, cost discussions occur in only one-third of RA office visits where changes are made to RA drug treatment.”

One alternative is the use of non-biologic DMARDs, such as methotrexate, which were once the standard treatment for RA. Both Medicare Advantage plans and PDP plans cover nearly all non-biologic DMARDs, with most charging fixed dollar co-pays that averaged $4 to $34 a month.

Researchers in Belgium recently found that a combination of older generic drugs (methotrexate, sulfasalazine and leflunomide) treated RA in its early stages just as effectively as biologics, but with less medication, fewer side effects, and at a significantly lower cost.

A similar study published in the New England Journal of Medicine found that RA patients who took three oral generic drugs (methotrexate, sulfasalazine and hydroxychloroquine) saw just as much improvement in their symptoms as those who used methotrexate and Enbrel, an injectable biologic sold by Amgen.

The average annual cost of the three drug therapy was about $1,000, compared to about $25,000 per year for Enbrel.

When Drug Tests Go Wrong

By Pat Anson, Editor

Robin Haas was driving to Disneyworld with her husband and three children in 2008 when their vehicle was rear-ended by a truck on a Florida highway. The accident left Robin with chronic back pain, and she had 17 surgeries over the next 11 months to repair her damaged spine.

It was only the beginning of her problems.

Last year Robin was kicked out of a pain management practice after two office urine tests failed to find any trace of the fentanyl patch she was wearing for pain relief – a red flag for physicians that a patient may be diverting a drug.

Initially, Robin says her doctor didn’t seem too concerned.

“When it happened the second time, he said ‘Don’t worry about it. It’s happened with several of my patients with the fentanyl patches,’” Robin said

About a week later, she was shocked to get a certified letter from the doctor discharging her.

“I don’t know what happened. I really don’t,” Robin told Pain News Network. “I was just mortified. I never did anything wrong in pain management. Ever.”

What happened to Robin is not uncommon. According to a recent study, immunoassay urine tests widely used by pain management doctors to screen patients for drug use are wrong about half the time – frequently giving false positive or false negative results.

“Clearly, people don’t know how to interpret these tests,” said Jeffrey Fudin, a pharmacist and patient advocate, who says most physicians have no idea how inaccurate immunoassay testing is.

“I’m positive that they don’t. I get probably 50 emails a week from all over the country from concerned physicians and nurse practitioners who want to make the right decision, but they’re not sure what to do,” said Fudin.

"The other problem is there are no standards. You can go to five different providers and be treated five different ways for the same results.”

Fudin says fentanyl may not show up on an opiate screen because it has a  different chemical structure compared to most commonly prescribed opioids. There can also be false negatives because an opioid is simply prescribed in too low of a dose to be detected.

Some medications can also trigger false positives for an illicit drug. Widely used pain relievers like naproxen and ibuprofen, for example, can trigger a false positive for marijuana. 

To help doctors correctly interpret immunoassay results, Fudin is developing an online app called Urintel that can help them decide whether to take a negative or positive drug screen seriously – and whether to order more reliable and more expensive confirmation testing in a laboratory.

“Basically, it’s educational and it’s not punitive to the patient,” said Fudin about his app.

“My goal is to make opioid therapy as safe as possible and to make it individualized for each patient. And also to be fair, not only to patients, but providers because it’s not their fault that they don’t have training in pharmacokinetics or biochemistry. It takes a lot of things to understand the complexity of this.”

Fudin’s app may be too late to help pain patients like Robin Haas. She just hopes more patients aren’t wrongly accused of diverting or abusing drugs because of a test that is so often wrong.

“I guarantee not one of my pills has ever hit the street,” says Robin.

The 43-year old Florida resident says the pain clinic told her that her urine samples were re-tested in a laboratory – at a cost of $18,000 – but the results came back the same. She’s still not sure what went wrong. The  clinic has refused to identify the laboratory it used or provide her with the lab results. She had to find a new doctor.

“It’s a horrible thing to happen to people. And when you’re having to deal with chronic pain to begin with, nobody should have to go through it,” she says.

Have you been wrongly accused of failing a drug test?

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Americans Recognize Medical Value of Marijuana

By Pat Anson, Editor

The perception of marijuana users as pot heads and lazy stoners may finally be changing to a new one: Patient.

According to a new survey by the Pew Research Center, the medicinal value of marijuana is the #1 reason why a majority of Americans now favor its legalization.

The survey of 1,500 adults found that 53% favor legalization, a dramatic shift from a decade earlier when only 32%  favored legalization.

When asked what was the main reason they support legalization now, 41% cited its medicinal benefits. Another 36% said marijuana was no worse than other drugs such as alcohol and cigarettes.

Nearly half of U.S. states have legalized medical marijuana and four states -- Colorado, Washington, Oregon and Alaska -- and the District of Columbia have passed measures to legalize its recreational use. The federal government still classifies marijuana as a Schedule I controlled substance with no accepted medical use, but in recent years has stepped back enforcement efforts in states where it is legal.

But the stigma long associated with marijuana has discouraged physicians from prescribing it and kept pharmaceutical companies from doing extensive research about its medical benefits.

Only two prescription drugs based on cannabinoids – the active ingredients in marijuana — have been approved by the Food and Drug Administration. Nabilone is a synthetic cannabinoid approved for treating nausea in cancer patients. Marinol is also used to treat nausea, and as an appetite stimulant. Both drugs can still be  prescribed “off label” by physicians to treat other conditions.

Some limited studies have found that marijuana is effective in relieving chronic pain and some of the symptoms of HIV/AIDS, cancer, glaucoma, and multiple sclerosis.

"Scientific data indicate the potential therapeutic value of cannabinoid drugs, primarily THC, for pain relief, control of nausea and vomiting, and appetite stimulation," the Institute of Medicine said in a report.

"Smoked marijuana, however, is a crude THC delivery system that also delivers harmful substances. The psychological effects of cannabinoids, such as anxiety reduction, sedation, and euphoria can influence their potential therapeutic value. Those effects are potentially undesirable for certain patients and situations and beneficial for others." 

Efforts to get a medical marijuana spray approved as a drug to treat cancer pain suffered a setback early this year when GW Pharmaceuticals (NASDAQ: GWPH) reported the results of a clinical trial showing that Sativex worked no better than a placebo in relieving cancer pain.

Sativex is getting a "fast track review" from the FDA to treat cancer pain. It is estimated that 420,000 cancer patients in the U.S. suffer from pain that is not well controlled by opioid pain medications.

U.S. Hydrocodone Prescriptions Dropping

By Pat Anson, Editor

The number of prescriptions filled in the U.S. for hydrocodone declined in 2014, the first concrete evidence that restrictions on the widely used opioid painkiller are starting to have an impact.   

According to the IMS Institute, 119.2 million prescriptions for hydrocodone pain medications were dispensed by pharmacies last year -- down from 129.5 million the year before – a decline of 8 percent. Hydrocodone is typically combined with acetaminophen in Vicodin, Lortab, Lorcet, Norco, and other hydrocodone products.

The IMS report also found that levothyroxine – a synthetic hormone used to treat thyroid deficiency -- has replaced hydrocodone as the #1 most widely filled prescription in the U.S.

The decline in hydrocodone prescriptions is striking because it was only in the last three months of 2014 that the painkiller was reclassified by the U.S. Drug Enforcement Administration from a Schedule III drug to a more restrictive Schedule II medication.

The DEA and Food and Drug Administration have been under pressure to restrict access to opioids because of the so-called epidemic of prescription drug abuse. Over 16,000 Americans die annually from painkiller overdoses, although most of those deaths involve other drugs or alcohol.

“The rise in opioid prescribing, which led to an opioid becoming America’s most prescribed medication, resulted in a public health catastrophe,” said Andrew Kolodny, MD, director of Physicians for Responsible Opioid Prescribing (PROP), which played an instrumental role in getting hydrocodone rescheduled.

“The trend is clearly moving in the right direction. I’d predict that up-scheduling will accelerate the decline in prescriptions. This will go a long way toward bringing the opioid crisis under control because with more cautious prescribing we are likely to see less new cases of opioid addiction.”

The rescheduling of hydrocodone limits pain patients to an initial 90-day supply of hydrocodone — and also requires them to see a doctor for a new prescription each time they need a refill. Prescriptions for Schedule II drugs also cannot be phoned or faxed in by physicians.

Since the rescheduling, many patients have complained that their doctors were no longer willing to prescribe hydrocodone and that pharmacists were unwilling to fill valid prescriptions. A recent survey found that many pain patients had suicidal thoughts after being denied a prescription. Others said that rescheduling hard been harmful to their relationship with their doctor.

Hydrocodone prescriptions were dropping even before the rescheduling took effect. They peaked in 2011 with nearly 137 million prescriptions filled by pharmacies.

The IMS report found that prescriptions of tramadol, a weaker Schedule IV opioid, rose by over 5% in 2014 – a possible sign that tramadol is being used as a substitute for hydrocodone. The number of tramadol prescriptions being dispensed has nearly doubled since 2010 from 28 million to over 44.2 million in 2014.

“I predicted tramadol prescriptions would increase,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“I think the overall amount of opioids has declined a little.  Physicians are prescribing less because of publicity, and fear of regulatory interventions. Payers are also limiting what patients can receive. Seems inappropriate that payers have so much control.”

Total spending on all prescription medications in the U.S. rose over 10% to $373.9 billion in 2014, according to IMS, with a record volume of 4.3 billion prescriptions filled.

Researchers Say Acetaminophen Dulls Emotions

By Pat Anson, Editor

Health experts have been warning for years about the risk of liver damage caused by taking too much acetaminophen.  Now a new study is out that found a previously unknown side effect of the drug: It also dulls emotions.

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications.

Researchers at Ohio State University conducted two studies involving over 80 college students, half of whom took a large dose of 1000 milligrams of acetaminophen and half who took a placebo. They waited 60 minutes for the drug to take effect.

The students then viewed 40 photographs from a database used by researchers to elicit emotional responses. The photographs ranged from the extremely unpleasant (crying, malnourished children) to the neutral (a cow in a field) to the very pleasant (young children playing with cats).

After viewing each photo, participants were asked to rate how positive or negative the photo was on a scale of -5 (extremely negative) to +5 (extremely positive). Then they viewed the same photos again and were asked to rate how emotional they felt, ranging from 0 (little or no emotion) to 10 (extreme amount of emotion).

Results in both studies showed that participants who took acetaminophen rated all photos less extremely than did those who took the placebo. Positive photos were not seen as positively under the influence of acetaminophen and negative photos were not seen as negatively. The same was true of their emotional reactions.

“People who took acetaminophen didn’t feel the same highs or lows as did the people who took placebos,” said Baldwin Way, an assistant professor of psychology at the Ohio State Wexner Medical Center’s Institute for Behavioral Medicine Research.

For example, people who took the placebo rated their emotional response relatively high (average score of 6.76) when they saw jarring photos of the malnourished child or the children with kittens. But people taking acetaminophen didn’t feel as much in either direction, reporting an average emotion level of 5.85 when they saw the same photos.

Neutral photos were rated similarly by all participants, regardless of whether they took the drug or not.

“This means that using Tylenol or similar products might have broader consequences than previously thought,” said Geoffrey Durso, lead author of the study and a doctoral student in social psychology at The Ohio State University.

“Rather than just being a pain reliever, acetaminophen can be seen as an all-purpose emotion reliever.”

Previous research has shown that acetaminophen reduces not only on physical pain, but also psychological pain.

“Most people probably aren’t aware of how their emotions may be impacted when they take acetaminophen,” said Way.

The study is published online in the journal Psychological Science.

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. In the U.S. over 50,000 emergency room visits each year are caused by acetaminophen, including 25,000 hospitalizations and 450 deaths.

Urine Drug Test Often Gives False Results

By Pat Anson, Editor

A urine drug test widely used by pain management and addiction treatment doctors to screen patients for illicit drug use is wrong about half the time – frequently giving false positive or false negative results for drugs like marijuana, oxycodone and methadone. 

The “point-of-care” or POC tests come with immunoassay testing strips that use antibodies to detect signs of recent drug use. Physicians like the urine tests because they can be performed in their offices, are inexpensive, and give immediate results. But experts say the tests are wrong so often that no doctor should base a treatment decision solely on the results of one test. 

“Immunoassay testing has an extraordinarily high rate of false positives and false negatives as compared to laboratory testing,” said Steve Passik, PhD, Vice President of Research and Advocacy for Millennium Health, which analyzed urine samples from nearly 4,300 POC tests obtained at addiction treatment clinics.The Millennium study was published in The Journal of Opioid Management.

A false positive reading means a drug was detected that isn’t actually there, while a false negative means the POC test missed finding a drug that was present in a urine sample.

The Millennium study found plenty of both.

False positive readings for marijuana, for example, were given over 21% of the time, while false negative results for marijuana also appeared about 21% of the time.

The POC tests had an even worse track record for oxycodone, a widely prescribed opioid pain reliever. False positive results were detected over 41% of the time and false negatives over 31% of the time for oxycodone.

“We always knew it wasn’t as sensitive and we always knew that it didn’t look for specific drugs within a class. But this was revealing in regard to how much it misses, with false negative and false positives rates in 40 to 50 percent in some instances,” said Passik.

“If we were in another area of medicine, let’s say oncology, and you had a tumor marker or a test that you were going to base important treatment decisions on, and it was as inaccurate as immunoassay is, the oncologists would never stand for it.”

Passik says “the word is starting to get out” how inaccurate the immunoassay tests are. But few patients are aware of it and some doctors are still dropping patients from pain management programs after POC tests found illicit or unprescribed drugs in their urine. 

Passik told Pain News Network that patients should insist on a second test if they feel the first one is wrong.

“If they think it’s a false positive, they need to ask the doctor to be re-tested. And particularly they should ask what method was used. And if they find out they were tested with immunoassay, they should say they want the same specimen either re-tested at the lab or they want to provide another specimen tested at the lab,” Passik said.

A laboratory test that uses chromatography-mass-spectrometry to break down and identify individual molecules is far more accurate than an immunoassay POC test, but it could cost thousands of dollars -- something many insurers and patients are unwilling to pay for.

And critics say Millennium – one of the largest drug screening companies in the nation – has produced a self-serving study designed to drum up more business for itself.

“It does not surprise me that Millennium would show a high rate of inconsistencies with the POC test,” said a source with broad experience in the drug testing industry. “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 told Pain News Network the data in Millennium’s study was “skewed toward exaggeration” and questioned the need for further testing.

“In addiction centers, there is not really a large demand for confirmation testing. I understand Millennium wants to increase that business because that’s what they do.  However, medical necessity does play into all laboratory testing.  The great majority of the time, when a patient in a treatment center is confronted with the results of a POC test that shows a drug in their system that shouldn’t be there, they will confess to taking the drug.  So, what would be the medical necessity of confirming that test?

“I believe many of the urine drug testing labs are promoting confirmation testing when it is not medically necessary.”

Millennium took offense that the validity of its study was being questioned.

“Millennium Health strongly disagrees with the characterization in the story 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.”

"Liquid Gold"

A growing number of doctors who treat addicts and chronic pain patients require them to submit to random drug screens. And some companies and government agencies also require employees and job applicants to submit to POC tests as a condition of employment.

The competition between drug screening companies for this business is intense. According to one estimate, drug testing has grown into a lucrative $4 billion dollar a year industry -- “liquid gold” as some have called it – that is projected to reach $6.3 billion by 2019.

But addiction experts say more reliable and expensive testing is needed, simply to be fair to patients.

“Heavy reliance on immunoassays in addiction treatment can be detrimental to the patient due to their higher risk for false positives and false negatives in comparison with more reliable technology, such as chromatography-mass-spectrometry,” said Michael Barnes, executive director of the Center for Lawful Access and Abuse Deterrence (CLAAD), a non-profit that gets some of its funding from Millennium.

“A false positive can be detrimental to a patient by subjecting her to unjust suspicion or accusations, unnecessary adjustments to the treatment plan, or the deterioration of the practitioner-patient relationship. A false negative may result in delayed diagnosis or misdiagnosis, false confidence that a patient has not relapsed, and failure to catch behavior that could eventual result in a preventable overdose death. Therefore, chromatography-mass-spectrometry is often more appropriate.”

Millennium’s Passik says most doctors recognize that both tests may be needed.

“These two different methods yield very different kinds of results,” Passik said. “If I was still practicing, I wouldn’t feel that immunoassay is accurate enough to be the only test that you use.”

Ironically, a federal court last year found Millennium guilty of giving illegal kickbacks to doctors by providing them with free POC test cups – the very tests the company says have an “extraordinarily high rate” of false results.

Two Drug Combo Relieves Neuropathy Pain

By Pat Anson, Editor

British researchers say a combination of two widely used drugs – an antidepressant and an opioid – can significantly relieve pain and other symptoms caused by neuropathy.

In a study published in the journal PAIN, researchers at Queens University say combining the painkiller morphine with the antidepressant nortriptyline relieved chronic neuropathic pain in nearly 90 percent of patients – significantly better than when either drug is used alone.

"Morphine and nortriptyline are excellent candidates for pain management because of the extensive research conducted on them, their low cost, and widespread availability all over the world," said Ian Gilron, MD, a professor in Queen's School of Medicine and anesthesiologist at Kingston General Hospital.

"Current neuropathic pain treatments are ineffective or intolerable for many sufferers so this new evidence supporting the morphine-nortriptyline combination is important news for patients."

Nortriptyline, an antidepressant sold under the brand names Aventyl and Pamelor, is already being used to treat pain in the arms and legs caused by multiple sclerosis. Morphine has long been used to treat both acute and chronic pain.

Neuropathic pain is characterized by tingling or burning sensations that develop as result of nerve damage caused by conditions such as shingles, diabetes, amputation, inflammation, and cancer. About 8% of adults worldwide suffer from neuropathy. Many drugs used to treat neuropathic pain, such as Neurontin and Lyrica, often don’t work or have unpleasant side effects.

In the double-blind, randomized study, 52 neuropathy patients were given a choice of trying every one of three treatments: morphine alone, nortriptyline alone, and a combination of the two drugs over six-week treatment periods. Patients were asked to record their pain levels and side effects during each treatment.

The average daily pain before treatment was 5.6, measured using a rating scale from 0-10. Average daily pain dropped to 2.6 when patients received the two drug combination. Patients taking nortriptyline and morphine alone rated their pain at 3.1 and 3.4, respectively.

Researchers said that common side effects for both drugs, which include constipation and dry mouth, did not worsen with the combined treatment.

"It's important to remember that we don't want to completely eliminate patients' ability to sense pain as it's a warning system for us, but we do want to find the right balance of pain relief and drug side effects," said Gilron

Nortriptyline and morphine are currently not available in a combined formulation. According to the Mayo Clinic, using the two drugs together is usually not recommended because they both cause sedation.

Study: One in Five Opioid Prescriptions for Low Back Pain

By Pat Anson, Editor

Doctors continue to prescribe opioids for low back pain, headaches and fibromyalgia – even though some medical guidelines recommend against their use for such common conditions, according to a large new study.

In an analysis of prescriptions filled for 12 million of its members between July 2013 and September 2014, pharmacy benefit manager Prime Therapeutics found that about one in five opioid prescriptions were written to treat low back pain.

"Our analysis found low back pain was the most common diagnosis among all members taking an opioid, even though medical guidelines suggest the risks are likely greater than the benefits for these individuals," said Catherine Starner, PharmD, lead health researcher for Prime Therapeutics.

Over 22% of those receiving long-acting opioids had been diagnosed with low back pain, nearly 5% had headache and about 2% were diagnosed with fibromyalgia.

In a position paper adopted last year, the American Academy of Neurology found there was “no substantial evidence” for long term use of opioids to treat low back pain, fibromyalgia and headache.

“Collectively, the data suggest that opioids do not improve function in low back pain and therefore should be avoided. While I am an advocate of minimizing opioids to every extent possible, I also believe that absolutes can be damaging," said Beth Darnall, PhD, a pain psychologist, clinical associate professor at Stanford University and author of Less Pain, Fewer Pills.

“In select individual cases, opioids may be one part of an effective pain management plan.  Even then, patients should be monitored closely and opioids used at the lowest dose for the shortest amount of time possible.  The opioid studies are based on large samples and there are always outliers; we must find ways of minimizing risks, protecting patients, and still leaving room for the reality that the medications may be effective for a minority of individuals.”

Nearly 9% of Prime Therapeutics’ members were prescribed at least one opioid during the study period. On average, the cost for those taking short-acting opioids was $72 per member, compared to $907 per member taking only long-acting opioids.

The company said a clinical program that assesses the appropriateness of long-acting opioids could help improve safety and reduce costs. A screening program could also identify members with a significant number of opioid claims in a short period, or those with diagnosed conditions that may not benefit from prolonged opioid use.

"Identifying these members and helping them find the most appropriate pain treatment for their condition could help reduce safety concerns," said Starner.

Darnall says an education program would also help – one that includes non-drug treatments.

“To reduce opioid prescriptions, patients must be given access to effective alternatives,” Darnall said in an email to Pain News Network. “Additionally, by providing patients with education regarding the limitations of opioids and associated risks clinicians may engage patients in their own care and motivate them to seek and try alternatives.  Such alternatives include psycho-behavioral interventions, self-management programs, graded exercise programs, rehabilitation approaches, and the like.”

Prime Therapeutics manages pharmacy claims for health insurers, employers, and government programs including Medicare and Medicaid. It is collectively owned by 13 Blue Cross and Blue Shield Plans, subsidiaries or affiliates.

Florida's State of Pain

By Pat Anson, Editor

If you suffer from chronic pain or care for someone who does, a recent half hour special report by WESH-TV in Orlando is “Must See TV” – whether you live in Florida or not.

In many ways Florida was ground-zero in the “War on Drugs,” with a sordid history of pill mills and unscrupulous doctors who dished out prescriptions for painkillers like they were candy.

In 2010, according to the Centers for Disease Control and Prevention, 98 of the top 100 oxycodone dispensing doctors in the country were in Florida and eight Floridians were dying every day from drug overdoses.

The state started cracking down. Law enforcement agencies raided doctors’ offices, shutdown over 100 pill mills, and heavily penalized pharmacies that were dispensing too many opioids.

The crackdown worked and overdoses soon declined, but somewhere along the way – in the view of many chronic pain patients -- the War on Drugs became a War on Patients. 

Florida doctors started dropping pain patients from their practices and pharmacies began turning away longtime customers who had never abused painkillers, forcing many to go on a “pharmacy crawl” in search of someone to fill their prescriptions. Faced with daily unrelenting pain, some patients resorted to suicide.

Much of what happened in Florida is now occurring on a national level, with pain patients being marginalized and viewed as drug addicts by a health care system that has grown fearful and paranoid.

WESH-TV investigative reporter Matt Grant and his producers do a commendable job covering all of this, explaining how legitimate pain patients have become unintended casualties in Florida’s War on Drugs.

You can watch his report below in three installments:

From Russia with Pain

By Pat Anson, Editor

If you’re a pain sufferer who has difficulty getting prescriptions written and filled for opioid pain medication – be glad you don’t live in Russia.

In Russia, even terminally ill cancer patients have trouble getting opioids. And some have committed suicide rather than spend their remaining days in pain.

In February, 11 cancer patients committed suicide in Moscow alone, according to a special report published in Meduza, a web-based Russian media outlet that operates out of Latvia.

“There’s no end to the pain. It won’t stop next morning, or tomorrow, or the day after. It won’t disappear if a tooth is pulled out or if drops of medicine are squeezed into your ear. If you don’t relieve the pain somehow, it eats you up right to the end. It’s absolutely unbearable,” one cancer patient was quoted as saying.

Getting painkillers in Russia is difficult for everyone, whether they have cancer or not. It can take up to three days for adults, according to Meduza, and for children up to 12 days.

Here’s what cancer patients have to do:

First they visit a general practitioner at a clinic, who will assess their pain levels and send them to an oncologist. The oncologist will then write up an assessment and send the patient back to the general practitioner, who will write up a prescription. The head of the clinic must then stamp the prescription, which is only valid for five days.

Clinics typically forward prescriptions to pharmacies at 4 pm – so if a patient doesn’t have a prescription approved by then, they have to wait until the next day.

All of these steps leading to long lines at the clinic, the oncologist and the pharmacy. The final indignity for patients is that they have to return the used containers and packaging from their previous medication to get a new one.

Adding to the stigma is that narcotic painkillers have long been deemed unnecessary in Russia – dating back to Soviet times. Patients who use the drugs are often treated like addicts and doctors who prescribe narcotics are sometimes punished as criminals.

This has led to a thriving black market for painkillers and soaring prices for pain medication that are sold legally. The government is reported to be conducting checks of pharmacies in major cities to protect against price gouging.

Meduza’s story about the suicides sparked a backlash and a heavy-handed attempt by the government to prevent other websites from reporting on poor access to pain medication. The pretext given for the censorship was a 2012 Russian law that prohibits online content advocating suicide and drug use. Any website violating the law can be blocked by the government.

One site was told to delete copy that simply said: "The wife of the deceased explained that her husband suffered from constant pain because of cancer and often said he was tired of being sick."

Moscow's deputy mayor disputed the notion that the suicides were in any way connected to lack of access to painkillers -- claiming that at least seven of the 11 people who killed themselves were unaware they had cancer.

The deputy head of the Russian Federation Council's constitutional law committee disputed the notion that forcing websites to delete information would prevent more suicides.

"The information about the reasons for suicides by cancer sufferers is socially significant in this case,” Senator Konstantin Dobrynin told the state news agency RIA Novosti. “Covering up such information could lead to even more victims."

The World Health Organization ranks Russia 38th out of 43 European countries in access to painkillers, but the problem isn’t unique to Russia.

According to one recent study, pain medications such as morphine and codeine were not widely available or virtually non-existent in a dozen eastern European countries stretching from Poland to Turkey.