Category Archives: Rheumatology

Counties Pursue Safer Drug Disposal

New programs to make it easier and safer for San Francisco Bay Area residents to get rid of unused medications are some of the first to try this on a large scale, and may serve as models for other cities and counties.

Since May 2012, a pilot program in San Francisco has allowed residents to drop off old medications at 13 pharmacies and 10 police stations (where controlled substances must be brought). San Francisco supervisors initially considered forcing drug companies to fund the program, and instead agreed to accept $110,000 from Genentech and the Pharmaceutical Research and Manufacturers of America to fund the program.

(Photo by J. Troha, courtesy of National Cancer Institute)

On July 24, supervisors in Alameda County (which includes East Bay cities such as Oakland and Berkeley) are likely to approve a Safe Drug Disposal Ordinance that would require drug companies to pay for disposal of their products or face fines of up to $1,000 per day, The Bay Citizen reports. Public agencies currently fund 25 drug disposal sites there, and the cash-strapped county wants the comparatively wealthy pharmaceutical industry to take more financial responsibility for the lifecycle of its products in order to reduce overdoses, accidental poisonings, and water pollution.

As we reported earlier this year, making prescription-drug “recycling” a cultural norm is one of five emerging public policies that could help the medical system keep opioids available while reducing the risk of addiction, abuse and accidental overdose, according to Keith N. Humphreys, Ph.D. Smaller versions have met with success, such as a drug take-back day organized by sheriffs in a small town in Arkansas (population 20,000) that brought in 25,000 pills, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He reports having no financial conflicts of interest on this issue.

Not everyone is happy with the idea. Trade associations for the pharmaceutical industry and biomedical companies argue that there’s no evidence that these programs will reduce poisonings, and they haven’t ruled out the possibility of suing to block the Alameda County ordinance, The Bay Citizen reports. The compromise that San Francisco reached for voluntary instead of mandatory funding from the pharmaceutical industry may be a middle ground.

In an era when government agencies have less and less money for public programs, it’s probably inevitable that they’ll pursue alternative financing for programs like this.

If your community has a drug disposal program, let us know how it’s working. Will these programs succeed, and will they reduce abuse, addiction, and accidental overdoses? We’ll keep an eye on this topic, and keep you posted.

–Sherry Boschert (@sherryboschert on Twitter)

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VA Adopts Innovative Project Nationwide

An innovative medical project that we reported in April has made the big time — a nationwide pilot program in the immense Department of Veterans Affairs system, the nation’s largest integrated health care system.

Project ECHO (Extension for Community Healthcare Outcomes) has been working wonders in New Mexico, Washington State, and a few other locations to bring specialty care to thousands of people who previously had little access to this care. Created by Dr. Sanjeev Arora of the University of New Mexico, Project ECHO connects primary care physicians with specialists in weekly case-management and educational teleconferences to give primary care physicians the support they need to manage complex patients with hepatitis C, asthma, chronic pain, rheumatic or cardiac disease, HIV, substance abuse, mental illness, high-risk pregnancy, childhood obesity, and more.

Dr. Arora (center, back turned) leads a Project ECHO videoconference. (Courtesy Project ECHO)

The U.S. Department of Health and Human Services awarded Project ECHO an $8.5 million Health Care Innovation grant in May 2012 to expand its operations in two states.

Impressed, the Department of Veterans Affairs cloned Project ECHO and tomorrow will launch a nationwide pilot program in the VA system that could help veterans get care in the local communities instead of traveling to specialists for treatment of heart failure, chronic pain, hepatitis C, etc. In our April 2012 video interview with Dr. Rollin M. Gallagher, deputy national program director for pain management in the Veterans Health Administration, he explains why Project ECHO is so appealing to the VA

The VA’s version, called Specialty Care Access Network-ECHO (or SCAN-ECHO), will kick off officially with a briefing by a panel of experts in Washington, D.C., that also can be viewed by Webcast (how appropriate) on Wednesday, July 11, 2012 from 10 a.m. to 11:30 a.m. Eastern time. Register here to view the Webcast.

The panel will feature Dr. Arora with Dr. Robert A. Pretzel, under-secretary for health in the V.A. system, Dr. John R. Lumpkin, director of the Health Care Group for the Robert Wood Johnson Foundation, which has funded much of Project ECHO’s work, and both specialty and primary care providers from the Cleveland VA Medical Center.

With any luck, the success of Project ECHO will echo across the country as this model of care expands.

–Sherry Boschert (@sherryboschert on Twitter)

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New Anti-Inflammatory Drugs Will End Anti-TNF Dominance

Tumor necrosis factor inhibitor drugs began to dominate treatment of inflammatory diseases like rheumatoid arthritis, psoriasis, and the inflammatory bowel diseases ulcerative colitis and Crohn’s disease a little over a decade again. Now, the time when the importance of the anti-TNFs will wane and newer drugs will take their place is clearly visible on the horizon. It hasn’t happened yet, but the era of anti-TNF dominance for treating inflammatory diseases that persisted throughout the 2000s will end in the next 5 years.

The anti-TNF era began in 1998 with the approval of etanercept (Enbrel) for rheumatoid arthritis and infliximab (Remicade) to treat Crohn’s disease. In subsequent years, the list of approved anti-TNFs expanded to include adalimumab (Humira), golimumab (Simponi), and certolizumab (Cimzia), and the approved indications grew to include many inflammatory disease of joints, the GI tract, and skin. The anti-TNFs revolutionized inflammatory disease treatment and made treatment to remission possible for many patients.

tumor necrosis factor (green, purple, black) and TNF receptors (blue)/courtesy Bassil Dahiyat; Science

But reports from just the past month show that new agents are overtaking the anti-TNFs.

In May, I reported from Digestive Disease Week on phase III trial results with vedolizumab, which was compared against placebo for patients with ulcerative colitis. One of the study investigators noted that vedolizumab beat the placebo arm for steroid-free clinical remission by 30 percentage points. “Nothing else is that good,” Dr. William Sandborn, professor of medicine and chief of gastroenterology at the University of California, San Diego, told me, and the benchmark he had in mind was the performance of the anti-TNFs in similar patients.

More recently, at the European Congress of Rheumatology earlier this month I heard a report on a head-to-head comparison of the anti-IL-6 drug tocilizumab (Actemra) and the anti-TNF adalimumab in patients with rheumatoid arthritis. After 24 weeks of monotherapy, patients on tocilizumab had nearly a fourfold higher remission rate than patients on adalimumab. Though the monotherapy trial design did not mimic the way most rheumatoid arthritis patients get treated, the new drug tocilizumab absolutely blew adalimumab out of the water in a rare head-to-head comparison among different classes of anti-inflammatory drugs.

And at the same meeting several talks highlighted another new anti-inflammatory class of agents coming soon to the U.S. market, the Janus kinase (JAK) inhibitors, such as tofacitinib, which is expected to received FDA approval later this summer. Phase III results show that tofacitinib has safety and efficacy that seems at least comparable to anti-TNF drugs, with the advantage of oral dosing.

Vedolizumab, tocilizumab, and tofacitinib are just the tip of new waves of anti-inflammatory drugs that will soon substantially alter a landscape that the anti-TNFs have mostly had to themselves for the past 14 years. For the moment, the anti-TNFs have the advantage of a longer track record for safety, but changing that is only a matter of time.

—Mitchel Zoler (on Twitter “mitchelzoler)

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Should Physicians Prescribe Positivity?

Scott Jordan Harris  is a U.K.-based blogger, editor, book author, movie critic, and sports writer. Remarkable, considering that he spends most of his time in bed. His primary diagnosis is myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome.

In a piece he wrote last week for the BBC’s website, Mr. Harris said that keeping a diary in which he focuses on the positive aspects of his life — at the suggestion of a doctor – keeps him “sane.”

©froglegs/Fotolia.com

“My depression told me my existence was filthy and barren…. After a few months of storing up the previously unrecorded richness of my life, my diary simply disproved that. I knew from re-reading the pages I’d written that I was doing interesting things — and I began to ensure I kept doing them simply to have something to write about. The diary was better than therapy; it pushed me forward through mental pain that had been holding me back.”

He added, “Doctors unaware of the realities of the lives of the chronically ill often suggest we waste what little energy we have noting down exactly how unwell we feel each day, how much we sleep and how little we do, so that they may study the results. These doctors are to be smiled at, and nodded to, and instantly ignored.”

So should physicians advise patients with chronic conditions to keep positive diaries?  I asked two experts.  Dr. Daniel Clauw, a rheumatologist who directs the University of Michigan’s Chronic Pain and Fatigue Research Center, referred me to his associate, Afton Hassett, Psy.D.

“That was a compelling story in the BBC and it actually does reflect my clinical and research experience as a pain psychologist,” Dr. Hassett told me.

Negative and positive affect (emotions) have been well-studied  in health in general and chronic and acute pain states in particular. There are numerous studies suggesting that positive affect plays an important role in pain outcomes. While few formal studies have evaluated the effectiveness of the exact intervention Mr. Harris described, there are studies   supporting the efficacy of similar positive psychology interventions for depression, Dr. Hassett said.

“Enhancing positive affect is likely a good thing for one’s mental and physical health. Sometimes just keeping a gratitude journal like the BBC article writer noted is all it takes. I always tell people to write down three different things each day for which you are grateful. After the first week or so you really start looking for the small wonders in your life: a great cup of coffee, a kind gesture from a complete stranger, the first tiny yellow flowers of spring.”

Courtesy Wikimedia Commons/4028mdk09/Creative Commons License

But Dr. David Spiegel, a psychiatrist who heads the Stanford University Center on Stress and Health, urges caution regarding positive psychology.   “I think the drumbeat for upbeat can be a little overwhelming… I agree with [Mr. Harris] that just focusing on how bad you feel you can dig yourself into a pit, but at the same time you can’t deny your feelings. The worst thing you can do to a depressed person is to tell them to cheer up.”

However, Dr. Spiegel, who works with breast cancer patients, noted that “you can help them by saying let’s give dimension to what’s bothering you, but also put that in perspective, and see other things that are good, that are positive. So it’s not one or the other…Happiness is not the absence of sadness.”

Dr. Spiegel said that advising patients with chronic conditions to keep a diary in general is an “interesting idea,” and that there is a literature base  for the medical benefits of journaling.

He advised that physicians suggest to their patients, “See if it helps you to have a daily journal of your journey through this illness, what your problems were and what your little victories were, and what you did that helped you deal with it and get beyond it.”

—Miriam E. Tucker (@MiriamETucker on Twitter)

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Review Not Favorable to Herbs for Osteoarthritis

Patients with osteoarthritis who routinely turn to devil’s claw, Indian frankincense, ginger, and other herbal medicines for symptom relief may want to think twice about this practice.

Image via Flickr user anolobb by Creative Commons License

According to a review of these products that appears in the January 2012 issue of Drug and Therapeutics Bulletin, a publication of the London-based BMJ Group, there is little conclusive evidence to justify their widespread use by patients with the disease (DTB 2012: 50:8-12). A press release about the review points out that few robust studies on the use of herbal medicines for osteoarthritis have been carried out. “And those that have frequently contain design flaws and limitations, such as variations in the chemical make-up of the same herb, all of which comprise the validity of the findings.”

Herbal medicines commonly used to treat osteoarthritis includes vegetable extracts of avocado or soybean oils (ASUs), cat’s claw, devil’s claw, Indian frankincense, ginger, rosehip, turmeric and willow bark. According to the review, the best available clinical evidence suggests that ASUs, Indian frankincense, and rosehip may work, “but more robust data are needed.”

Some herbal medicines may cause adverse reactions in patients taking other medicines and prescription drugs. For example, chronic use of nettle can interfere with drugs used to treat diabetes, lower blood pressure, and depress the central nervous system while willow bark can cause digestive symptoms and renal problems.

The review characterized the use of herbal medicines for osteoarthritis as “generally under-researched, and information on potentially significant herb-drug interactions is limited.”

Although the UK Medicines and Healthcare products Regulatory Agency has approved Traditional Herbal Registrations for several herbal medicinal products containing devil’s claw for rheumatic symptoms, “the trial results for this herb are equivocal,” the review states. “There is little conclusive evidence of benefit from other herbs commonly used for symptoms of osteoarthritis, such as cat’s claw, ginger, nettle, turmeric and willow bark. Healthcare professionals should routinely ask patients with osteoarthritis if they are taking any herbal products.”

The review did not include data on glucosamine and chondroitin sulfate.

— Doug Brunk (on Twitter@dougbrunk)

Photo courtesy anolobb’s photostream

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Rheumatology Rewards Innovative Imaging

Rheumatology has a been a tad slower than other specialties to adopt more advanced imaging modalities, preferring to stick with ultrasound and venturing into MRI. Based on this year’s still image winner in the “Image of the Year” contest at this year’s American College of Rheumatology meeting though, the specialty appears to be embracing innovative new ways of imaging rheumatic diseases.

Image courtesy of the American College of Rheumatology and Dr. Chaudhari

This year’s winner is a combined PET-CT image of the finger joints in patients with psoriatic arthritis. The image was submitted Abhijit Chaudhari, Ph.D. of the UC Davis School of Medicine in Sacramento.

 According to Dr. Chaudhari’s poster from the meeting, his group has built an extremity scanner that is capable of sequentially performing 3D positron emission tomography (PET) and fusing the image with a 3D anatomical CT image. In the poster, they reported their initial experience in using this system for assessing metabolic activity in RA, PsA and OA of the hand. Regions of enhancement on PET (F18-FDG) are markers of increased metabolic activity and, in turn, inflammation.
 
While the technique is still in early trials, the researchers hope that one day they will be able to not only identify the disease but also monitor early response to anti-TNF-alpha therapy in RA and characterize bone remodeling (osteoblastic) activity in early OA. 
 
The best overall submission and category winning submissions from this year’s contest will be published in a future issue of Arthritis & Rheumatism and will be featured in the online Rheumatology Image Bank.
 
You can read more about this year’s ACR meeting and watch video interviews with key presenters at Rheumatology News.com.
 
Kerri Wachter (On Twitter @knwachter)

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How Vitamin D Supplements May Help Lupus Patients

It seems like every week brings a new study about the benefits of vitamin D: It builds bones, tames psychotic symptoms in bipolar teens, and strengthens the immune system. It is the immune system benefit that attracted the interest of Dr. Benjamin Terrier and colleagues at the Pitié-Salpêtrière Hospital in Paris, France.

Courtesy of Mikael Häggström, via Wikimedia Commons

The researchers studied 24 people with lupus to determine the possible benefit of vitamin D supplementation on their immune systems. They presented their findings at this year’s annual meeting of the American College of Rheumatology.

So, did it help? Yes, to some extent. The patients received 100,000 IU of vitamin D weekly for 4 weeks, and then the same amount monthly for 6 months. Serum 25(OH)D levels, which had been below normal in all patients at baseline, were normal when measured after 2 months and 6 months.

Most importantly, the number of regulatory T cells increased and the number of T helper lymphocytes decreased after 2 months and also after 6 months of vitamin D supplementation. In addition, antibody-producing memory B cells decreased after 2 months, and activated CD8+ T cells (thought to be associated with lupus in particular) decreased after 6 months.

An added bonus: None of the patients reported adverse events associated with vitamin D, including hypercalcemia or lithiasis.

The findings are preliminary, Dr. Terrier said, and large, randomized controlled trials are needed to confirm the results.

Currently, no one is advocating that lupus patients increase their vitamin D with heavy supplementation, said Dr. Sam Lim of Emory University in Atlanta, Georgia. Dr. Lim served as moderator at the press conference in which the findings were presented.

However, “the study is very important because it is a link to take [the research] to the next step,” Dr. Lim said.

–Heidi Splete (On Twitter @hsplete)

Image courtesy of Mikael Häggström, via Wikimedia Commons

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