Vitamin D Lowers Inflammation from MS

By Pat Anson, Editor

A new study is adding to the growing body of evidence that Vitamin D supplements can be used to treat multiple sclerosis (MS) and other inflammatory chronic pain conditions.

The pilot study published by Johns Hopkins physicians in the journal Neurology found that taking a high dose of vitamin D3 is safe for people with MS and may help regulate the body’s hyperactive immune response.

“These results are exciting, as vitamin D has the potential to be an inexpensive, safe and convenient treatment for people with MS,” says study author Peter Calabresi, MD, director of the Johns Hopkins Multiple Sclerosis Center and professor of neurology at the Johns Hopkins University School of Medicine. “More research is needed to confirm these findings with larger groups of people and to help us understand the mechanisms for these effects, but the results are promising.”

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.

Low blood levels of vitamin D – known as the “sunshine vitamin”-- have been linked to an increased risk of developing MS.

People who have MS and low levels of vitamin D are also more likely to have greater disability and more disease activity.

In the Johns Hopkins study, 40 people with relapsing-remitting MS received either 10,400 international units or 800 international units (IU) of vitamin D3 supplements every day for six months. Patients with severe vitamin D deficiency were not included in the study. The current recommended daily allowance of vitamin D3 is 600 IU.

Blood tests at the start of the study, and after three and six months, measured the amount of vitamin D in the blood and the response in the immune system’s T cells, which play a key role in MS.

Participants taking the high dose of vitamin D reached optimal levels of Vitamin D in the blood (40 to 60 ng/ml), while the group taking the low dose did not reach that target. The people taking the high dose also had a reduction in the percentage of inflammatory T cells related to MS severity. The people taking the low dose did not have any noticeable changes in the percentages of their T cell subsets.

“We hope that these changes in inflammatory T cell responses translate to a reduced severity of disease,” says Calabresi. “Other clinical trials are underway to determine if that is the case.”

Another recent study in Neurology by Danish researchers found that MS patients who spent time in the sun every day during the summer as teenagers developed the disease later in life than those who spent their summers indoors. Ultraviolet rays in sunlight are a principal source of Vitamin D, which has a wide range of positive health effects, such as strengthening bones and inhibiting the growth of some cancers.

Low levels of serum vitamin D have also been linked to fibromyalgia. In a study of over 1,800 fibromyalgia patients published in the journal Pain Physician, researchers at National Taiwan University Hospital found a “positive crude association” between chronic widespread pain and hypovitaminosis D, which is caused by poor nutritional intake of Vitamin D, inadequate sunlight or conditions that limit Vitamin D absorption.

Pain News Network columnist Crystal Lindell began taking Vitamin D supplements when her blood levels were found to be very low. Within a few months she was feeling better, exercising more, and losing weight. You can read Crystal’s story by clicking here.

My Life with Fibromyalgia: An Open Letter to CDC

(Editor’s Note: The Centers for Disease Control and Prevention today reopened for public comment its proposed guidelines for opioid prescribing. Comments, which will accepted until January 13, 2016,  can be made by clicking here.)

By Emma Christensen, Guest Columnist

The over-regulation of opioid medications is so very wrong for pain patients. To withdraw their access to opioid medications is reckless and punitive.

Having lived with fibromyalgia for over 15 years, searching for credible medical help and treatment has been one of the most trying experiences of my life.

One physician I sought help from was so at a loss for treating the pain I was experiencing that he put me on heavy doses of morphine. When I learned more about the medication he put me on, I began to question if I truly needed that much in order to live. 

When another physician told me I was very young to be on that high of a dosage, I searched and found literature that supported using a low dosage of morphine to take the edge off of the pain. This method of pain reduction was done in order to allow patients to function using additional alternative solutions such as Tai Chi exercise, foam rolling and trigger point therapy to help reduce significant amounts of their pain. Eventually, I tried these methods and was able to step down to the lowest dose (15mg) that is available for doctors to prescribe.

emma christensen

This low dosage worked well. I felt like I was improving and having the first bits of success in pain reduction that did not require a pill or large amounts medication.  It was just enough to take the edge off the pain. This allowed me to begin to move, exercise, and use other alternative methods of pain relief.  However, it was not possible to do this without the opioid cutting into that first layer of pain. 

I describe pain as an onion -- I had just begun to peel it.  I could not do this without relying upon the small amounts of morphine I was prescribed.

I hate the fact that I have to take this medication. I hate the fact that there is not a better solution. However, all things considered, would you rather pay for a person to be on disability and all that goes with that? Or would you rather have them remain functional and working at a job supporting themselves? I chose to be functional and working, thereby keeping my self-respect and dignity.

The day someone wants to walk a day in my shoes with this painful condition, is the day that they can tell me how my doctor and I can treat my condition.  The pain is unbearable, horrific, and relentless. If I stop any of the methods I use to fight it, it can revert to the levels it was at before I began fighting it; as if I had never done anything to fight it at all.

The low dose morphine has helped me stay functional and keep my job all these years. It takes the edge off of the horrific pain that comes with having fibromyalgia. If anything, I have been more responsible than you have, as the “monitors of society” that wish to deprive me of the one thing that allows me to remain functional.

For years, I have taken only a 15 mg dose and not more, as was originally prescribed. I am prescribed two pills a day for 30 days. I have the extra burden of having to pick up the prescription in person and to sign for it, for each refill. For me, this means I must take time off from work to get the script (if my doctor’s office is not open on Saturday morning). This is another burden.  How much more difficult do you want to make my life?  Why can’t a quarterly prescription be available for someone like me who has a history of appropriate medication usage?

I am frightened to go without the medication because my pain is real. It hurts, fibromyalgia hurts, and it brings me to tears. Just moving my arms and legs is excruciating due to the myofascial knots and inflamed fascia that I endure with this condition.

If you want to question my need for this medication, go nose to nose with me and tell me why. Tell me what other solution you suggest that is just as good and will do what I need it to do, so I can work and keep my job. I have been out there trying every solution I can find for the last 15 years.

If you think you can solve the pain, solve it! Let me or any other person who lives with chronic pain be the judge of your solution, not you. It is very obvious to those of us living in chronic pain that the CDC’s opioid guidelines are being made by people who do not experience chronic pain themselves!

If I had a choice, I would not use this medication. I would not take morphine if I did not need it. I am against using illegal drugs.  In my lifetime, I have worked in two police departments, was married to a cop, and my father-in-law was a chief of police. Additionally, I hold a Master’s degree in Public Administration. I know full well what the abuse of drugs does to families and society.

However, that doesn’t give you the right to tell me and my doctors how to treat my condition.

Blanket mandates of restriction, without credible analysis of the situation, is not a substantial enough reason to deny a class of people who are suffering and in pain their medication.  Proposed regulations should not only solve an administrative problem; but, enhance the medical profession and the support the pain patient simultaneously. Any proposals that do not measure up to this standard are beneath consideration for good practices and reasonable implementation by professional public administrators. 

Like any other crime, incidences of abuse and misuse must be regulated and substantiated in a court of law following the principles of due process. To do otherwise is punitive and unjust towards people who are innocent of such allegations.

There is another reason I felt inspired to write this open letter to the CDC.  It is my education that requires me to respond. If I do not respond and say something now while I have a chance, I could be responsible for my own loss if they take away my medication. 

We all have to stand firm to let the CDC administrators know that they cannot make decisions in a vacuum.  If we allow them to get away with this, then we are less of a democracy and more dictatorship run by administrators who do not know the negative effect that they are having on our society.  My degree is all about building a "good society." Arbitrary rules against pain patients are not the solution to this problem.  You cannot solve a law enforcement issue by doing the minimum of public administration.

If you want to help chronic pain patients, such as myself, put your energies into finding a cure for the pain patients that require these medications to cope with their daily lives; remove the barriers to treatment. You can have my medical case files; my treatments are an open book, as far as I am concerned. I have never misused my medications and do not ever plan to. Please stop persecuting those of us who are ill and find a better way to spend your time.  I am one voice, but I speak for many people who are in pain.

This open letter to the CDC is intended to invite, stimulate and encourage further discussion and commentary on this most important issue of pain management and law enforcement of illegal drugs.

Emma Christensen lives in Illinois. She was diagnosed with fibromyalgia in 2000 after a whiplash injury from a vehicle accident. Emma is currently working to be certified as a fibromyalgia health coach and hopes to help others navigate their way through treatments in order to feel and be better.  She has a Facebook support group called Fibromyalgia Solutions.

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

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

Naltrexone ‘Changed Life’ of Fibromyalgia Patient

By Donna Gregory Burch

The pain in Janice Hollander’s legs was so excruciating that she wanted to cut them off. Diagnosed with fibromyalgia in 2013, she’d progressed through the normal litany of prescription drugs doled out by physicians – Lyrica, Cymbalta, gabapentin, muscle relaxers and narcotics – all without finding relief.

Then she happened to catch an episode of the Dr. Oz Show where a guest discussed using low-dose naltrexone (LDN) as a treatment for chronic pain. A few days later, she convinced her doctor to write a prescription and took her first dose of LDN.

“After about seven days, my pain lessened,” said Hollander of Michigan. “It lessened by 10 or 20 percent. That was huge! Even just that little bit of lessening was huge.”

After four weeks, the depression that had been stymying her for years lifted. At six weeks, she saw a noticeable increase in her energy levels. Her brain fog improved, and her memory returned.

Hollander has been taking LDN for about year now, and she’s probably one of its biggest fans within the fibromyalgia community. She regularly shares her success story in online support groups.

Hollander still has fibromyalgia symptoms, but they are more manageable thanks to LDN.

“I would say my leg pain is pretty much gone,” she said. “[LDN] has completely changed my life. I don’t know that I would be here today if it wasn’t for it. I don’t think I could go for another year in the misery I was in.” 

A growing number of fibromyalgia sufferers like Hollander are finding relief using LDN. It’s an unusual discovery since LDN is best known in the addiction treatment community. The U.S. Food and Drug Administration approved LDN to treat addiction to certain opiate drugs in 1984.

janice hollander

Dr. Jarred Younger, who conducted two LDN/fibromyalgia studies at Stanford University, believes LDN has an anti-inflammatory effect on the brain.

“This is one of the few drugs that can do that in the brain because it crosses the blood-brain barrier,” Younger said.

In simple terms, the brain contains microglial cells that look for problems within the central nervous system. When they discover an abnormality, these cells release chemicals into the body that cause fatigue, pain, cognitive disturbances and other symptoms common among fibromyalgia patients. In a healthy person, these chemicals are intended to slow down the body, to force it to rest, so that it can heal from whatever has caused the abnormality. In fibromyalgia, some researchers hypothesize this normal central nervous system response gets activated and doesn’t shut off.

“It’s like the central nervous system thinks you have an infection when you don’t,” Younger explained.

Fibromyalgia sufferers often speculate about what caused their condition, and researchers have debated various triggers for years. Viruses (herpes, Epstein Barr, etc.), chronic stress, genetics, obesity, aging and pollution are suspects, but according to Younger, it could be all of these.

He believes LDN works because it calms the microglial cells and reduces brain inflammation.

Penn State University researcher Ian Zagon posits a different mechanism behind LDN. Zagon’s opioid blockade hypothesis surmises that LDN blocks the brain’s opioid receptors, essentially tricking the body into increasing production of natural pain-suppressing chemicals.

Theoretically, both hypotheses could be correct.

Younger’s two Stanford University studies showed LDN outperformed Lyrica, Cymbalta and Savella, the three drugs currently approved to treat fibromyalgia in the U.S., and it did so with minimal side effects. The most common side effects are headache, insomnia, vivid dreams and nausea – all of which usually disappear over time.

“Probably 65 percent of people get an appreciable decrease of symptoms,” Younger said.

But more research is needed to confirm these early findings.

Next year, Younger will conduct at least two LDN/fibromyalgia studies at his new facility, the Neuroinflammation, Pain and Fatigue Lab at the University of Alabama at Birmingham.

One study will try to parse out the most effective dose of LDN for fibromyalgia. Most LDN users are prescribed the drug off-label, between 1.5mg and 4.5mg daily. But some rheumatologists have shared anecdotal accounts that certain patients respond better to higher doses, ranging up to 9mg.

A second trial will pair LDN with dextromethorphan, a common cough suppressant that’s believed to work similarly to LDN.

But many fibromyalgia sufferers aren’t waiting for the research. They’ve found ways to secure a prescription and try LDN for themselves.

Linda Elsegood, founder of the U.K.-based LDN Research Trust, has helped thousands of people gain access to LDN. She credits LDN with stabilizing her multiple sclerosis. At her worst, Elsegood was wheelchair bound, had no control of her bowels or bladder and had lost much of her sight and hearing. After 18 months on LDN, she was able to walk again on her own and had a reversal of most of her symptoms.

After her remarkable recovery, she wanted to educate others on the benefits of LDN.

“I wanted people to know that there is a choice, if you’ve been told, like me, that there’s nothing else that can be done for you,” she said. “Look into LDN. Do your research. … It is amazing the number of people who’ve found LDN works for them for so many different conditions.”

In addition to fibromyalgia, early research has found LDN to be useful in reducing the symptoms of certain autoimmune and central nervous system conditions, including multiple sclerosis, Crohn’s disease, rheumatoid arthritis and others.

But few doctors know about LDN as an emerging treatment, so it can be difficult to get a prescription.

“Some doctors are too busy to read the information,” Elsegood explained. “Some will not think outside of the box. It’s not what they learned in medical school, so they’re not prepared to consider something that is alternative. Other doctors won’t prescribe it because there aren’t enough trials.”

Unfortunately, it’s unlikely that any of the major drug companies will ever study LDN because it’s an older, generic drug and little profit can be made from it. So it falls to innovative researchers, like Younger, who secure donations and grants to fund trials.

Patients often encounter doctors who refuse to prescribe LDN even though it has a proven safety record and a low risk of side effects. The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website. For those who can’t find an LDN-friendly doctor locally, there are physicians who offer phone and online LDN consults.

“My advice is to always research it yourself, and then address it with your doctor,” Hollander said. “And if your doctor won’t agree to letting you try it, then find a doctor who will.

“I would drive to Florida to get it if I had to. It makes that big of a difference. I just wish more doctors would prescribe it, and more people would find help with it.”

For a list of helpful LDN resources, visit www.fedupwithfatigue.com/low-dose-naltrexone.

Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained symptoms. Donna is the founder of Fed Up with Fatigue, a blog devoted to helping those with fibromyalgia and ME/CFS live better with these conditions.

Donna is an award-winning journalist whose work has appeared online and in local newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.

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.

Tommie Copper Tarnished By Fed Charges

By Pat Anson, Editor

Some of the shine has come off athletic apparel company Tommie Copper, Inc.

The company has agreed to pay $1.35 million to settle federal charges that it deceptively advertised its copper-infused compression clothing would relieve pain and inflammation caused by arthritis, fibromyalgia and other chronic diseases.

Tommie Copper’s settlement with the Federal Trade Commission also requires the company and founder Thomas Kallish to have “competent and reliable” scientific evidence before making any future claims about pain relief, disease treatment, or the health benefits of their products.

Tommie Cooper advertised its copper-infused garments in infomercials, brochures, social media, and print media such as Arthritis Today magazine. The ads claimed the clothing alleviated pain caused by multiple sclerosis, arthritis, and fibromyalgia; and could provide pain relief comparable to or better than drugs or surgery.

Some of the infomercials feature talk show host Montel Williams, who suffers from multiple sclerosis, declaring, “Tommie Copper truly is pain relief without a pill.”

 “It’s tempting to believe that wearing certain clothing will eliminate severe pain, but Tommie Copper didn’t have science to back its claims,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “If you see an ad for a product that promises to replace the need for drugs or surgery, talk to a healthcare professional before you spend your money.”

The company’s website now only claims its products “can be worn all day to provide relief from everyday aches and pains.” The clothing, including sleeves, braces, shirts and socks, range in price from $29.95 to $69.50.

The proposed federal court order imposes an $86.8 million judgment against Tommie Copper, which will be suspended upon payment of $1.35 million by the company within seven days . The company neither admitted or denied any of the allegations in the settlement.

The so-called “healing power” and pain relieving power of copper can be traced back thousands of years. But a 2013 study by British researchers found that copper does nothing to alleviate the pain, swelling, or disease progression of rheumatoid arthritis. The study, published in PLOS ONE, found that copper bracelets worn by 70 patients provide no more meaningful therapeutic effect than a placebo.

Exercise Helps Reduce Chronic Pain of Fibromyalgia

By Pat Anson, Editor

This is the time of year when people start thinking of New Year’s resolutions – and losing weight and getting more exercise are two of the most common ones. New research suggests fibromyalgia sufferers should consider them both to relieve pain and improve their quality of life.

Exercise is known to relieve some types of chronic pain, but researchers at the University of Granada in Spain wanted to know what types of fitness are most effective in decreasing pain and improving mood in fibromyalgia patients. Fibromyalgia (FM) is a poorly understood disorder that is characterized by deep tissue pain, fatigue, depression and insomnia.

Researchers enrolled 468 female fibromyalgia patients in the study to assess their aerobic fitness, muscle strength, flexibility and motor ability. The study, published in the journal Arthritis Care & Research, also used a scale to quantify the women’s emotional response to chronic pain, such as catastrophizing (viewing something worse than it actually is) and self-efficacy (belief in the capacity to control things).

“Overall, higher physical fitness was consistently associated with lower levels of pain, lower pain-related catastrophizing, and higher chronic pain self-efficacy,” the researchers found.

Women with high muscle strength and high flexibility had the lowest levels of pain; and those with high flexibility and aerobic fitness had the best catastrophizing and self-efficacy profiles.

Another study, published in the Journal of Clinical Rheumatology, found that fibromyalgia patients were more likely to exercise less, be overweight, depressed, and take more medications.

Researchers at the Cleveland Clinic enrolled over 300 fibromyalgia patients in the study and collected detailed information about their demographic, socioeconomic, clinical, medical, surgical, and psychiatric history.

Nearly three quarters of the participants were either overweight or obese, as defined by the World Health Organization’s BMI (body mass index). Less than 10% of the obese patients said they performed regular aerobic exercise.

Obese patients were also significantly more likely to suffer from major depression and to be taking multiple medications.

“Compared with normal-weight patients, obese FM patients in our study were taking more medications for FM, including SSRIs, other antidepressants, and antipsychotic drugs, as well as gabapentinoids (Lyrica and Neurontin), all known to potentially cause weight gain,” the researchers found.

Interestingly, overweight and obese patients were also more likely to have a history of physical and sexual abuse than normal weight FM patients (48% vs. 34%).

The authors recommend that physicians treating overweight FM patients advise them to lose weight and exercise more.

Lyrica Fails in Nerve Pain Study

By Pat Anson, Editor

Lyrica was originally marketed as an anti-seizure medication for epilepsy, although that’s never stopped Pfizer from looking for new ways to have doctors prescribe its blockbuster drug -- for everything from anxiety to shingles to fibromyalgia.

But efforts to get Lyrica approved as a treatment for post-traumatic nerve pain appear to have reached a dead end. Pfizer says a Phase III clinical study found that pregabalin – the generic name for Lyrica – worked no better than a placebo in controlling chronic nerve pain caused by traumatic accidents or surgery.

“The study did not meet its primary efficacy endpoint,” Pfizer said in a brief statement about its 15-week, double-blind, placebo-controlled study

There is no treatment currently approved by the Food and Drug Administration for post-traumatic neuropathic pain.

Lyrica is currently approved for use in over 130 countries. The FDA has approved Lyrica to treat chronic nerve pain caused by diabetes, fibromyalgia, epilepsy, spinal cord injury and post-herpetic neuralgia caused by shingles. The drug is also prescribed “off label” to treat a variety of other conditions, including lumbar spinal stenosis, the most common type of lower back pain in older adults.

According to ClinicalTrials.gov, dozens of new studies are underway to test the effectiveness of pregabalin on conditions such as muscle cramps, coughs, irritable bowel syndrome, scoliosis, addiction, and phantom limb pain.

Lyrica is Pfizer’s top selling drug with annual worldwide sales of over $5 billion. Earlier this year, the company agreed to pay $400 million to settle a shareholder lawsuit over allegations it marketed Lyrica and several other drugs off-label. The lawsuit stemmed from a $2.3 billion settlement with the federal government in 2009 for fraudulent marketing and illegal kickbacks paid to doctors who prescribed Lyrica and other Pfizer products.

Common side effects of Lyrica are dizziness, blurred vision, nausea, headache, weight gain and fatigue. Pfizer says Lyrica may also cause suicidal thoughts in about 1 in 500 patients who use it. The company also advises patients not stop taking Lyrica without talking to their doctor. Suddenly stopping the medication may result in withdrawal symptoms such as headaches, nausea, diarrhea, trouble sleeping, increased sweating, and anxiety.

Pfizer Expands Financial Aid to Patients

Pfizer recently announced it was expanding its financial assistance to patients by doubling the allowable income level for people to receive medications without a copayment.

Under Pfizer's RxPathways program, the company will cover copayments for Lyrica and 43 other medicines for both uninsured and underinsured patients earning up to four times the federal poverty level. The new limits are $47,080 annually for a single person and $97,000 for a family of four.

The RxPathways program helped about 350,000 patients last year, and Pfizer expects more this year because of the soaring cost of many drugs.

For more information about financial aid and discounts offered by other drugmakers, see our Patient Resources section.
 

‘Chili Pepper’ Patch Works Better Than Lyrica

By Pat Anson, Editor

A skin patch containing a synthetic substance found in chili peppers works better than pregabalin in treating patients with neuropathic pain, according to the results of a new study conducted in Europe.

Pregabalin is the generic name for Lyrica, a medication made by Pfizer that is widely prescribed for neuropathy, fibromyalgia and other chronic pain conditions.

Nearly 660 adults with moderate to serve peripheral neuropathic pain (PPN) caused by shingles were randomly assigned to groups receiving either a single treatment with the Qutenza patch or a daily dose of pregabalin.

The 8% capsaicin patch uses a synthetic form of capsaicin, the substance that gives chili peppers their heat, to dull pain-sensing nerves in the skin.

By the 8th week of the study, a little over half of the patients in both groups had achieved pain relief of at least 30 percent. However, the median time to pain relief in the capsaicin group was 7.5 days, compared to 36 days in the pregabalin group. Those who used the Qutenza patch were also more satisfied with their treatment and had fewer side effects.

The study, which is published in the European Journal of Pain, was funded by Astellas Pharma Europe Ltd., which makes the Qutenza patch.

"This is an important and well-conducted study that was designed to mimic everyday practice, allowing those patients randomised to the pregabalin arm to be individually titrated to the optimal tolerated dose,” said lead investigator Maija Haanpää, a professor in the Department of Neurosurgery at Helsinki University in Finland. “We found that topical treatment with the capsaicin 8% patch was non-inferior to the current standard of care. This means that there is now another treatment option for people with peripheral neuropathic pain, especially those patients who are very sensitive to the side effects of systemic medication or for those who do not wish to take tablets every day."

Until now, no head-to-head clinical trials have directly compared the capsaicin patch to pregabalin or other treatments for PNP.

"There is a need to tailor treatment to individual patients and these data show that the capsaicin 8% patch is an efficacious agent to manage patients with peripheral neuropathic pain," said Dr. Andreas Karas, Senior Director, Medical Affairs for Astellas Pharma.

In September of this year, the European Commission approved a label extension for Qutenza to include diabetic patients with neuropathic pain. In the United States, Qutenza has only been approved by the FDA for the management of neuropathic pain associated with postherpetic neuralgia.

Neuropathic pain is characterized by tingling pain that develops as a 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. Common side effects of Lyrica are dizziness, nausea, headache, weight gain and fatigue.

In addition to neuropathic pain, Lyrica is approved by the FDA to treat chronic pain associated with fibromyalgia, epilepsy, shingles, diabetic peripheral neuropathy, and spinal cord injury. The drug is also prescribed “off label” to treat lumbar spinal stenosis, the most common type of lower back pain in older adults.

Lyrica is Pfizer’s top selling drug with annual worldwide sales of over $5 billion.

Miss Understood: Vibrant Trial

(Editor’s note:  Several weeks ago we were contacted by a sales representative for Neurovative Technologies, a Canadian manufacturer of medical devices that use vibration to relieve chronic pain. These “Vibrant” devices sell for about $300 each and, we were told, “have been able to decrease pain and stiffness and increase range of motion in 95% of our OA, RA and Fibromyalgia patients.” The company was invited and agreed to provide a Vibrant device for back pain at no cost to PNN columnist Arlene Grau for a test run. Arlene suffers from fibromylagia and rheumatoid arthritis.)

By Arlene Grau, Columnist

There are many people who suffer the same pain day in and day out with little to no relief from medication, acupuncture, medical devices, etc. My pain begins in my back and spreads throughout my body. Recently, I was asked to give a drug free and non-invasive device called Vibrant a try to see if it helped with some of the pain I was suffering from. I received the device that is designed for back pain management.

During my time using the device, which was about two weeks, I have found that there is no change in my pain level or relief for my back pain.

The device is recommended for use in 16 minute sessions.  It can be used as many times as you'd like during the day, however it is not recommended that anyone use it for an extended period of time all at once.

It is extremely easy to use. You just push the “on” button and it does all the work. It also comes with a charger and backpack for storing or carrying, which I thought was pretty neat.

The Vibrant device reminded me of a massage chair, but I kept wanting to raise the level of intensity and couldn't because it doesn't come with that feature.

It did however help relieve minor aches and pains related to everyday life. My husband even tried it and said that he found it to be relaxing.

I also have a TENS unit which was prescribed by my pain management doctor and I feel like I get a lot more relief from that than the Vibrant device. As far as being able to target my pain and getting deep down into the problem areas, I feel like the Vibrant device fell short.

It's possible that it's meant for smaller aches and pains, but as far as rheumatoid arthritis and fibromyalgia patients go, there really are no minor pains related to our diseases.

Arlene Grau lives in southern California. She suffers from rheumatoid arthritis, fibromyalgia, lupus, migraine, vasculitis, and Sjogren’s disease.

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.

Low Levels of Vitamin D Linked to Fibromyalgia

By Pat Anson, Editor

Some recent studies are highlighting the importance of the "sunshine vitamin" -- Vitamin D -- in maintaining overall health, as well as possible links to fibromyalgia, rheumatoid arthritis and other chronic conditions.

Low levels of serum vitamin D were found in over 1,800 fibromyalgia patients with chronic widespread pain, according to the results of a meta-analysis (a study of studies) published in the journal Pain Physician.

Researchers at National Taiwan University Hospital found a “positive crude association” between chronic widespread pain and hypovitaminosis D, which is caused by poor nutritional intake of Vitamin D, inadequate sunlight exposure or conditions that limit Vitamin D absorption.

The most severe type of hypovitaminosis D causes general body pain, especially in the shoulder, rib cage, lumbar and pelvic regions.

A number of previous studies have explored the association between hypovitaminosis D with widespread musculoskeletal pain, including fibromyalgia, but the results were inconclusive. Fibromyalgia is a poorly understood disorder that is characterized by deep tissue pain, fatigue, depression and insomnia.

According to the Vitamin D Council, low levels of Vitamin D could be the result of fibromyalgia, rather than the cause of the disease.

Vitamin D helps control levels of calcium and phosphate in the blood and is essential for the formation of strong bones and teeth. Vitamin D also modulates cell growth, improves neuromuscular and immune function, and reduces inflammation

Sources of Vitamin D include oily fish and eggs, but it can be difficult to get enough through diet alone. Ultraviolet rays in sunlight are a principal source of Vitamin D for most people.

Taking Vitamin D supplements can improve exercise performance and lower the risk of heart disease, according to the findings of a small study at Queen Margaret University in Scotland presented at the Society for Endocrinology annual conference in Edinburgh.

Researchers gave 13 healthy adults Vitamin D supplements or a placebo daily for a period of two weeks.

The adults supplemented with Vitamin D had lower blood pressure compared to those given a placebo, as well as lower levels of the stress hormone cortisol in their urine. Previous studies suggest that Vitamin D can block the action of an enzyme which is needed to make cortisol.

A fitness test found that the group taking vitamin D could cycle 6.5km (about 4 miles) in 20 minutes, compared to just 5km at the start of the experiment. Despite cycling 30% further, the Vitamin D group showed lower signs of physical exertion.

"Our pilot study suggests that taking vitamin D supplements can improve fitness levels and lower cardiovascular risk factors such as blood pressure", said Dr. Raquel Revuelta Iniesta, co-author of the study. "Our next step is to perform a larger clinical trial for a longer period of time in both healthy individuals and large groups of athletes such as cyclists or long-distance runners.”

Around 10 million people in England have low vitamin D levels. On average, one in ten adults has low levels of vitamin D in summer, compared to two in five in winter. Because people with darker skin are less efficient at using sunlight to make vitamin D, up to three out of four adults with dark skin are deficient in winter.

"Vitamin D deficiency is a silent syndrome linked to insulin resistance, diabetes, rheumatoid, and a higher risk for certain cancers,” said lead author Dr. Emad Al-Dujaili. "Our study adds to the body of evidence showing the importance of tackling this widespread problem.”

Danish researchers recently reported that exposure to sunlight may delay the onset of multiple sclerosis (MS). Patients who spent time in the sun every day during the summer as teenagers developed the disease later in life than those who spent their summers indoors.

CDC Should Consider Marijuana as Alternative to Opioids

By Ellen Lenox Smith, Columnist

Presently in our country, those that are successfully using opioids for pain relief are feeling dirty and lost -- largely due to fears about addiction and  overdoses. Pain patients often have to cope with physicians who are reluctant to prescribe opioids and pharmacies that are sometimes unwilling to fill their prescriptions.

The Centers for Disease Prevention and Control (CDC) is considering new guidelines that would encourage doctors to shift even further away from prescribing opioids, leaving the patient with little effective medication to turn to.

Why is the CDC not even considering the use of medical marijuana to help these people in need?

The Boston Herald recently reported that hundreds of opioid addicts are being treated successfully in Massachusetts with medical marijuana.

“We have a statewide epidemic of opioid deaths,” said Dr. Gary Witman of Canna Care Docs, which issues medical marijuana cards in seven states. “As soon as we can get people off opioids to a non-addicting substance — and medicinal marijuana is non addicting — I think it would dramatically impact the amount of opioid deaths.”

Witman is treating about 80 patients at a Canna Care clinic who are addicted to opioids, muscle relaxants or anti-anxiety medications. After enrolling them in a one-month tapering program and treating them with cannabis, Witman says more than 75 percent of the patients have stopped taking the harder drugs. Medical marijuana gave them relief from pain and anxiety — and far more safely than opioids.

Patients across the country are also learning they can use cannabis for pain relief, decreasing or even eliminating their use of opioids.  Marijuana works far better than other substitutes since it is not synthetic and does not cause organ damage or deaths like opioids can in some circumstances.

Medical marijuana works naturally on what is known as the “endocannabinoid system,” binding to neurological receptors in the brain that control appetite, pain sensation, mood and memory.

Here in Rhode Island, my husband and I have witnessed the amazing transition of pain patients on opioids that chose to transition to medical marijuana.  Most that turn to cannabis do so to eliminate the side effects of opioids and concerns about their long term use. They still achieve pain relief but know they are gaining that relief in a safer manner -- no organ damage, no teeth getting destroyed, no concerns of addiction and no deaths.

Marijuana may still be illegal at the federal level, but it is legal in 23 states and the District of Columbia, and millions of people are discovering its therapeutic benefits. The CDC should consider adding medical marijuana to the list of “non-opioid” therapies in its guidelines.

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.

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.

Medical marijuana is legal in 23 U.S. states and the District of Columbia, but is still technically illegal under federal law. Even in states where it is legal, doctors may frown upon marijuana and drop patients from their practice for using it.

How I Finally Took Myself Off Cymbalta

By Crystal Lindell, Columnist

To be fair, the first time I took myself off Cymbalta, it was less of a “took myself off” situation and more of a “I ran out of medication and money, and couldn’t get my refill for a few days so I just thought I’d skip a few doses” situation.

But it turns out that going off that stuff cold turkey is seriously hell. It made me dizzy and nauseous, and basically electrocuted my brain every few minutes with something called “brain zaps.” When I finally realized that all of this was because I didn’t refill my prescription, I went to the pharmacy, got another dose, and about a day later, got my brain back.

Except I didn’t really get my brain back, because Cymbalta essentially turns your brain off.

Being on Cymbalta, which is now available as a generic called duloxetine, made me so tired that 16 hours of sleep felt like I just pulled an all-nighter. It killed my sex drive. It canceled out all my creative thoughts. And it basically made me feel like I was living in a London fog every day. I could sort of see the world, but not really. Also, it made me gain 30 pounds.

So, to sum up, Cymbalta really sucks.

The worst part about this whole thing though isn’t the side effects. It’s that my doctor originally put me on Cymbalta to help with my chronic pain, but it actually did nothing at all to help that.

Although I will admit that it did curb all those suicidal thoughts that I was having because I wasn’t on enough pain medication and I thought I was going to feel like a semi-truck was crushing my ribs all day, every day, for the rest of my life.

But eventually I did get on the right mix of pain meds, and I realized my future wasn’t quite as bleak as I had thought. And so, even after that horrible experience of kind-of, accidentally going off Cymbalta last winter, I decided that I really wanted to go off it completely. And I thought maybe I’d just try the cold turkey thing again.

And before you’re all, “OMG!! You are an idiot!! Why would you ever take yourself off a drug like that cold turkey?” There are three things you should know:

1. I’ve had doctors, including one at the freaking MAYO CLINIC, tell me before to go off all sorts of drugs cold turkey, including sleeping pills, antidepressants, and opioids. So I got the impression that all this business about not going off certain drugs cold turkey is more of a suggestion than a recommendation.

2. My doctor never told me NOT to go off Cymbalta cold turkey. Ever. Not one time. Not even in passing as he shook my hand at the end of the appointment. Not even when I told him I was thinking about going off the drug and he shut me down by saying, “Just stay on it. It’s probably doing more than you think.” I also live in a really small town, with one small pharmacy, and they never gave me any sort of information when I picked up my prescription telling me about the side effects of going off it cold turkey.

3. (And probably most important) The dosing is such that going off Cymbalta cold turkey is kind of your only option. As far as I can tell, the lowest dose is 20 mg and it only comes in capsules, so you can’t just cut them into smaller and smaller pieces until you’ve weaned off it. After you're on the smallest dose, there’s no choice but to go cold turkey.

Also, honestly, I really did think the withdrawal symptoms would subside after maybe a day. I was wrong. After about a week, I couldn’t take it anymore and I went back on Cymbalta.

I really, really wanted off this drug though, so I decided to call Dr. Google. And I found out that some people were just opening the capsules and pouring a little more out each day until they got down to nothing. I decided to do the same thing. And, while it ended up taking me a few months of meticulously opening the capsules and eyeing it every day, I finally got completely off Cymbalta. And I was lucky enough to avoid most of the side effects that I experienced when I went off it cold turkey.

When I confessed all this to my doctor though, I’m pretty sure he A) Totally did not believe me about the brain zaps, and B) Was secretly judging me for my methods — especially since the makers of Cymbalta explicitly say you should not open the capsules.

I've written before about how horrible Cymbalta is though, and how people are actually suing Eli Lilly, the makers of the drug, because they’ve been kind of shady with how they portray the withdrawal symptoms.

“Studies show that between 50% and 78% of Cymbalta users experience antidepressant withdrawal symptoms after discontinuing the drug. Yet the drug label misleadingly states that Cymbalta withdrawal symptoms occur in only 1% to 2% of cases,” claims attorney Steven Gacovino, one of several lawyers suing Eli Lilly on behalf of patients.

That’s a pretty big difference. So maybe my doctor really didn’t know that it could be an issue for me to go off Cymbalta cold turkey and that’s why he never mentioned it. Or maybe he really did think it was helping me more than I realized. I don’t know.

I do know that I’m really glad I got off that drug. I also know that if any other chronic pain patient ever asks me my opinion about Cymbalta, I will definitely advise them against taking it for pain.

I just hope it’s not too late.

Crystal Lindell is a journalist who lives in Illinois. After five years of unexplained rib pain, Crystal was finally diagnosed with hypermobile Ehlers-Danlos syndrome.

New Wearable Devices for Chronic Pain

By Pat Anson, Editor

With opioid pain medications becoming harder to get and many patients looking for safer alternatives with fewer side effects, a growing number of companies are offering wearable “electrotherapy” devices for pain relief.

There’s the Cefaly headband for migraines, ActiPatch for sore muscles, AcuKnee for osteoarthritis, and the Quell nerve stimulator, which is designed to treat a range of chronic pain conditions. All are part of a fast growing $2.8 billion market for wearable medical devices.

“There’s a big problem brewing on the horizon. And that is the pain medications are being removed from the market, slowly but surely,” says Phillip Muccio, President and founder of Axiobionics, which has been making customized electrotherapy devices for 20 years.

“Electrical stimulation has a way of reaching into the body and interacting and coordinating what happens to the body. That’s why it a fascinating area of medicine because not a lot of things will do that, especially non-invasively and non-pharmacologically.”

Most of the new devices use a form of electrical stimulation to block or mask pain signals – a technique developed decades ago known as Transcutaneous Electric Nerve Stimulation (TENS).

Unlike the old TENS units, which are typically used for about 30 minutes, wearable devices are designed to be worn for several hours at a time or even while sleeping.

image courtesy of axiobionics

“TENS is like a short acting opioid. It’s basically only effective when it’s on,” said Shai Gozani, MD, President and CEO of Neurometrix. “If you’re going to deal with chronic pain, you have to have a wearable, chronically usable device, because pain can be two hours a day or it could be 24 hours a day. TENS devices historically haven’t been designed at all for wear-ability or continuous use.”

Neurometrix recently introduced Quell, an electrotherapy device that Gozani compares to a spinal cord stimulator. But instead of being surgically implanted near the spine like a stimulator, Quell is worn externally on the upper calf below the knee.

image courtesy of neurometrix

“We really look at spinal cord stimulation as the model. We’re trying to make that available but in a non-invasive, wearable way -- versus TENS devices which are really intended for local muscle stimulation. We don’t stimulate the muscles, we stimulate the nerve alone,” Gozani told Pain News Network.

“The upper calf has a lot of nerves. It’s comfortable. It’s discrete. So it meets the requirement to have a large segment of nerves to stimulate, but it’s also highly usable from a wear-ability perspective.”

A small study recently conducted by Neurometrix found that over 80% of Quell users had a significant reduction in pain and two-thirds were able to reduce the amount of pain medication they were taking.  Participants in the study had several different types of of chronic pain, including fibromyalgia, sciatica, neuropathy and arthritis.

When it comes to clinical studies, medical device makers have a clear advantage over pharmaceutical companies, which often have to spend years and tens of millions of dollars proving the safety and effectiveness of their drugs before they’re approved by the Food and Drug Administration. Device makers are held to a lower regulatory standard.

“Devices are approved by FDA basically for safety and not necessarily for efficacy. It’s a lot easier to demonstrate that with a device than if you have to demonstrate a new drug. You basically run one study or two and show that nobody got electrocuted by a TENS unit and you’re good to go,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

Device makers can even get fast track approval from the FDA without any clinical studies -- if they say a new device is substantially equivalent to an older device already on the market.  Quell, for example, was given clearance by the FDA because of its similarity to Sensus, another Neurometrix device that's worn below the knee for pain relief.

A significant disadvantage for device makers is that most are not covered by public or private health insurers – meaning patients have to pay for them out of pocket. Three years ago, Medicare stopped covering TENS for low back pain, saying the technology was “not reasonable and necessary.”

The lack of reimbursement also makes many doctors unwilling to prescribe wearable devices and unfamiliar with the technology behind them, which stifles innovation.  For that reason, Neurometrix took an unconventional path and made Quell available without a prescription – bypassing insurers and doctors so it could market directly to consumers for $249 a unit.

“We thought it was imperative to get it over the counter. We wanted to make sure it was accessible to patients," said Gozani. "Wear-ability changes everything. Wear-ability is the game changer in terms of optimizing pain relief. I think it's huge."

Pfizer Loses Lyrica Patent Case

By Pat Anson, Editor

A British judge has strongly rebuked Pfizer for making "groundless threats" against doctors and pharmacies in the UK to prevent them from prescribing or selling cheaper generic versions of  Lyrica for pain relief.

Judge Richard Arnold ruled against Pfizer in a patent protection case, saying emails and letters the U.S. drug maker sent to British healthcare providers were “calculated to have a chilling effect on the willingness of pharmacies to stock and dispense generic pregabalin.”

Pregabalin is the generic version of Lyrica, a blockbuster drug that generates over $5 billion in sales annually for Pfizer.

The company's patent on Lyrica for the treatment of epilepsy and anxiety expired last year, but a secondary patent for pain is good until 2017.  However, that didn't stop British doctors from prescribing pregabalin "off-label" for pain. According to Pharmalot, about 80% of UK patients on pregabalin are using it to treat pain -- amounting to about $386 million in lost Lyrica sales for Pfizer.

Arnold's ruling that doctors and pharmacists were not infringing on the patent does not impact Pfizer's patent rights outside of the UK. The company said it would appeal the decision.

“Our intention was only ever to communicate the existence and importance of our second medical use patent for the use of Lyrica in pain," Pfizer said in a statement. “With the benefit of hindsight and having navigated particularly challenging and complex legal issues, we wish we had been able to explain this better and sooner."

Ironically, Pfizer paid $2.3 billion dollars in 2009 to settle criminal and civil charges in the U.S. for the off-label marketing of Lyrica and other medications – the very sort of off-label use it was trying to stop in the U.K.

Lyrica is one of only three drugs approved by the U.S. Food and Drug Administration to treat fibromylagia. Although it is the most widely prescribed medication for fibromyalgia, many patients have written to Pain News Network warning about its side effects.

"I have memory loss and bad vision from Lyrica. Some of my memory will never be restored," said Dana.

"Lyrica made me fat, extremely fat, I was depressed on this drug too. No thanks," said Freda.

"I have tried Lyrica. I was falling on the floor. Could not walk without holding onto a cane," said Nancy. "It's time for researchers to find medications that are meant to treat Fibromyalgia, and not second or third off label uses of other meds that were never intended for FM. After 25 years, I'm really tired of waiting!"

Quell Device Relieves Variety of Pain Conditions

By Pat Anson, Editor

A new medical device that uses electrical nerve stimulation was effective in managing chronic pain in patients suffering from arthritis, neuropathy, fibromyalgia and other conditions, according to a small clinical study conducted by NeuroMetrix (NASDAQ: NURO), the device’s manufacturer.

Pain News Network recently featured the Quell Wearable Pain Relief device in a column by J.W. Kain, who reported that Quell “worked brilliantly” in relieving her chronic neck and back pain.

Eighty eight people were enrolled in a 60-day trial of Quell. All had chronic pain for at least year and nearly a quarter had more than 15 years of pain. Participants had “complex medical histories” with arthritis (61%), diabetic nerve pain (40%), sciatica (27%), and fibromyalgia (26%) as the most common conditions.

Over 80 percent of the participants said Quell relieved their chronic pain and improved their overall health. The largest measured changes were in pain relief, along with improved sleep, general activity, and walking ability.

Over two-thirds of the patients said Quell also reduced the amount of pain medication they were taking

image courtesy of neurometrix

"We are pleased with these results. They represent the first formal evaluation of self-administered wearable intensive nerve stimulation. Quell provided substantial pain relief and improvement in quality of life measures,” said Shai N. Gozani, MD, President and CEO of NeuroMetrix.

“We were not surprised that two-thirds of the subjects reduced their use of pain medications, as we have consistently received this anecdotal feedback from Quell users over the past several months.”

Quell is available over-the-counter and does not require a prescription. It relieves pain by using electric stimulation to “mask” pain signals before they reach brain, much like a TENS unit.  The device, which costs $249, is lightweight and designed to be worn over the upper calf during the day or night.

The marketing of Quell for the treatment of chronic pain was approved by the Food and Drug Administration in 2014, but NeuroMatrix did not begin shipping the device to healthcare providers until this summer. It is also available through the company’s website.

A study abstract, “Treatment of Chronic Pain with a Novel Wearable Transcutaneous Electrical Nerve Stimulator,” has been accepted for poster presentation at the annual PAINWeek conference next month in Las Vegas.

Major Study Underway for New Fibromyalgia Drug

By Pat Anson, Editor

Lyrica, Cymbalta, and Savella -- the only drugs approved by the U.S. Food and Drug Administration to treat fibromyalgia -- may be getting some competition.

A Japanese drug company, Daiichi Sankyo, is conducting clinical trials on mirogabalin, a new drug that could finally give fibromyalgia sufferers an alternative to the three approved medications -- which often don’t work or have too many side effects.

Daiichi Sankyo is currently enrolling patients in the “ALDAY” study, a large Phase III clinical trial evaluating the safety and efficacy of mirogabalin in treating pain from fibromyalgia. About 4,000 patients will be studied at 800 clinical centers in 40 different countries.

“We need men and women, 18 and older, who have been suffering from fibromyalgia pain for the last 3 months to participate in the ALDAY research study. If you qualify, you will be seen by a study doctor and receive all study-related medications at no cost. Compensation for study-related time and travel may also be available,” the company says on a website promoting the study.

A unique aspect of the ALDAY study is that it pits mirogabalin head to head against Lyrica (pregabalin), the top-selling fibromyalgia medication.  Both drugs bind to calcium channels that are believed to cause neuropathic pain. An earlier Phase II study suggested that mirogabalin may be 17 times more effective than Lyrica, although some critics questioned whether the design of the study was fair.

Advanced trials are also underway in Asia evaluating mirogabalin in the treatment of pain from diabetic peripheral neuralgia and postherpetic neuralgia (shingles).

“Pain associated with the neurologic conditions of diabetic peripheral neuropathic pain, postherpetic neuralgia and fibromyalgia can be debilitating,” said Lesley Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director of the Women’s Health Research Program, University of Cincinnati and lead investigator of the ALDAY program. “New treatment options are needed to help people living with these neurologic conditions relieve and manage their chronic pain and hopefully, improve their function and quality of life.”

The National Institutes of Health estimates that 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, depression, mood swings, and insomnia. There is no known cure and the disorder is difficult to treat.

Many fibromyalgia sufferers have complained that Lyrica, Cymbalta and Savella – which were originally developed to treat other disorders like epilepsy, anxiety, and depression – are ineffective for fibromyalgia.

“There are far too many off-label prescriptions written. These two classifications, anti-seizure and antidepressant, are frequently prescribed for pain on and off label. They come with far more side effects than opioids, but physicians feel, (and) are told, they are doing the right thing, when we are lacking statistics on after-market deaths associated with them,” said Celeste Cooper, a retired nurse, fibromyalgia sufferer and patient advocate.

“They completely reorder the brain and it is my opinion that these drugs should only be prescribed by physicians who specialize in brain chemistry (psychiatrist and neurologist) and know what interactions and side effects to alert patients, which is not being done currently.”

Dozens of patients wrote to Pain News Network with complaints of side effects from Lyrica and Cymbalta after a recent story about lawsuits involving the drugs.

“I took Cymbalta for a while. It didn't stop the pain of fibromyalgia, it just put 30 lbs. on me. I had my doctor wean me off. I got horrible Brain Zaps for a long time and felt terrible. Never take Cymbalta!” wrote Carol Fruzzetti.

“When I was on Lyrica I was literally walking into walls in my house or holding onto the wall for fear I was going to pass out I would get so dizzy. It made me feel like I was drunk all the time. I did not drive for fear I would kill myself or someone else. I will never take this drug again,” wrote Lana Straten.

Lyrica is one of Pfizer’s top selling drugs, generating $5.1 billion in revenue in 2014.  

Cymbalta generated annual sales of $5 billion for Eli Lilly until its patent expired in 2013 and cheaper generic versions of Doluxetine became available.

Savella generated sales of “only” $105 million for Forest Laboratories in 2013.