Tuesday, December 18, 2012

Growing up we were told to drink a glass of milk with each of our three meals if we wanted strong and healthy bones. Now a new study says that we should limit our 2-5 year olds to no more than two glasses of milk per day.

Kids' Diet: Two Cup Limit for Milk

Higher consumption of cow's milk was linked to higher vitamin D levels but lower serum ferritin as a measure of iron levels (both P≤.0001), Jonathon Maguire, MD, MSc, of St. Michael's Hospital in Toronto, and colleagues found.

Each cup consumed was linked to 6.5% higher vitamin D and 3.6% lower iron on average, the group reported online in Pediatrics.

Two cups a day seemed sufficient to keep vitamin D levels up with minimal effect on iron for most 2- to 5-year-olds, they found in the primary practice-based study, although children with darker skin pigmentation may require more milk during winter months.

The study findings fit with guidelines from the American Academy of Pediatrics that suggest no more than two cups (500 mL) of cow's milk a day from ages 2 to 6 to avoid iron deficiency.

Both nutrients are critical for kids. Vitamin D is necessary for bone health and likely disease prevention too; iron plays a key role in brain and psychomotor development.

The study included 1,311 healthy children, ages 2 to 5, seen at seven large Toronto primary care group practices in the TARGet Kids! research network.

Parents reported that the average daily intake of cow's milk was a little under 2 cups (460 mL).

About a third of the children had 25-hydroxyvitamin D levels under the 75 nmol/L threshold recommended as optimal in Canadian guidelines; 6% were deficient with levels under 50 nmol/L.

Serum ferritin averaged 31 μg/L, with 4% falling under 12 μg/L.

How appropriate those iron levels might be wasn't clear, as there aren't any consensus recommendations on optimal iron stores for children, the investigators noted.

Children who drank three 250-mL cups of milk a day versus two had:
  • 5.5-nmol/L higher 25-hydroxyvitamin D (95% CI 3.9 to 7.1)
  • 1-μg/L lower serum ferritin (95% CI 0.3 to 1.7)
Analysis by other common clinical scenarios suggested that up to two cups a day kept median 25-hydroxyvitamin D over 75 nmol/ L, except for kids with dark skin who didn't get vitamin D supplements during the winter.

That group apparently required 3 to 4 cups of cow's milk per day to maintain 25-hydroxyvitamin D at the same threshold, although as the researchers noted, the observational results couldn't determine causality.

Higher milk intake didn't appear to be as good for children still using a bottle. In these children, higher milk intake didn't correlate with higher vitamin D levels, but were associated with sharper decreases in iron levels across gender, skin pigmentation, season, and vitamin D supplementation scenarios.

Possible explanation for this findings could be that parents under-reported milk intake from bottles, or other things like juice put in them, or that bottle use by this age group replaces vitamin D- and iron-containing solid foods, Maguire's group suggested.

"Regardless, reported cow's milk consumption among children using a bottle appears to have little benefit on micronutrient stores, suggesting that bottles should not be filled with cow's milk or used at all in this age group," they wrote.

Parent reporting was a limitation of the study, as was inclusion of children in a single urban setting at a northern latitude, which may limit how generalizable the results are.

The TARGet Kids! program was supported overall by the Canadian Institutes of Health Research Institute of Human Development, Child and Youth Health and the Institute Nutrition Metabolism and Diabetes, as well as the St. Michael's Hospital Foundation.
The analysis was supported in part by the Canadian Institutes of Health Research. The Pediatric Outcomes Research Team was supported by a grant from The Hospital for Sick Children Foundation.
The researchers reported no conflicts of interest.

Wednesday, December 12, 2012

With healthcare reform focused on how to pay for that care rather than reducing the need for it, a NYT's opinion piece asks whether healthcare interventions should be mandated in an effort to do what has been proven scientifically effective in preventing a condition. The idea raises the question of what is morally and fiscally ethical.

 

 

The 2,000-Year-Old Wonder Drug


THE inexorable rise in health care spending, as all of us know, is a problem. But what’s truly infuriating, as we watch America’s medical bill soar, is that our conversation has focused almost exclusively on how to pay for that care, not on reducing our need for it. In the endless debate about “health care reform,” few have zeroed in on the practical actions we should be taking now to make Americans healthier. 

An exception is Mayor Michael R. Bloomberg of New York, who is setting new standards that we would do well to adopt as a nation. In the last several years, he’s changed the city’s health code to mandate restrictions on sodas and trans fats — products that, when consumed over the long term, harm people. These new rules will undoubtedly improve New Yorkers’ health in years to come. 

Such bold moves prompt a provocative question: when does regulating a person’s habits in the name of good health become our moral and social duty? The answer, I suggest, is a two-parter: first, when the scientific data clearly and overwhelmingly demonstrate that one behavior or another can substantially reduce — or, conversely, raise — a person’s risk of disease; and second, when all of us are stuck paying for one another’s medical bills (which is what we do now, by way of Medicare, Medicaid and other taxpayer-financed health care programs). 

In such cases, encouraging a healthy behavior, or discouraging an unhealthy one, ought to be a matter of public policy — which is why, for instance, we insist on vaccinating children for the measles, mumps, rubella and polio; we know these preventive strategies save lives. 

Under that rationale, then, why not make it public policy to encourage middle-aged people to use aspirin?
Developed in 1897 by the German chemist Felix Hoffmann, aspirin, or acetylsalicylic acid, has long proved its value as an analgesic. Two millenniums before that, Hippocrates, the father of modern medicine, used its active ingredient — which he extracted from the bark and leaves of the willow tree — to help alleviate pain and fevers. 

Since then, we’ve gained insight into both the biological mechanism and the effects of this chemical compound. Many high-quality research studies have confirmed that the use of aspirin substantially reduces the risk of cardiovascular disease. Indeed, the evidence for this is so abundant and clear that, in 2009, the United States Preventive Services Task Force strongly recommended that men ages 45 to 79, and women ages 55 to 79, take a low-dose aspirin pill daily, with the exception for those who are already at higher risk for gastrointestinal bleeding or who have certain other health issues. (As an anticoagulant, aspirin can increase the risk of bleeding — a serious and potentially deadly issue for some people.) 

New reports about aspirin’s benefits in cancer prevention are just as convincing. In 2011, British researchers, analyzing data from some 25,000 patients in eight long-term studies, found that a small, 75-milligram dose of aspirin taken daily for at least five years reduced the risk of dying from common cancers by 21 percent. 

In March, The Lancet published two more papers bolstering the case for this ancient drug. The first, reviewing five long-term studies involving more than 17,000 patients, found that a daily low-dose aspirin lowered the risk of getting adenocarcinomas — common malignant cancers that develop in the lungs, colon and prostate — by an average of 46 percent. 

In the second, researchers at Oxford and other centers compared patients who took aspirin with those who didn’t in 51 different studies. Investigators found that the risk of dying from cancer was 37 percent lower among those taking aspirin for at least five years. In a subsection of the study group, three years of daily aspirin use reduced the risk of developing cancer by almost 25 percent when compared with the aspirin-free control group. 

The data are screaming out to us. Aspirin, one of the oldest remedies on the planet, helps prevent heart disease through what is likely to be a variety of mechanisms, including keeping blood clots from forming. And experts believe it helps prevent cancer, in part, by dampening an immune response called inflammation. 

So the question remains: given the evidence we have, why is it merely voluntary for physicians to inform their patients about a health care intervention that could not only help them, but also save untold billions in taxpayer dollars each year? 

For some men over the age of 45 and women over 55, the risks of taking aspirin outweigh any benefits — and patients should talk with their doctors before taking any medication, including something as familiar as aspirin. 

But with such caveats in place, it still ought to be possible to encourage aspirin’s use in those for whom the potential benefits would be obvious and the risks minimal. Just as we discourage smoking through advertising campaigns, for example, shouldn’t we suggest that middle-aged Americans speak to their doctors about aspirin? Perhaps pharmacists or even health insurance companies should be enlisted to help spread the word about this disease-prevention drug? 

The right policy will have to be hammered out, of course. But if we’re going to address the country’s sky-high medical bill, we’re going to have to address the need for Americans to be active in protecting their own health. 

Everyone may want the right to use tobacco products and engage in other behaviors that are unequivocally linked with disease — or have the right not to wear a seat belt and refrain from other actions that may protect their well-being. But, if so, should society have the obligation to cover the costs of the consequences? 

As the former Supreme Court justice Potter Stewart once said, “There is a big difference between what we have the right to do and what is right to do.” Health care reform should, at long last, focus on the latter. 

David B. Agus is a professor of medicine and engineering at the University of Southern California and the author of “The End of Illness.”

Wednesday, December 5, 2012

Court ruling allowing drug off-labeling as free speech may be a boon for drug companies but will it be good for patients? Will marketing ultimately trump the ethics of "first do no harm?"

Court: Off-Label Drug Marketing Is 'Free Speech'

A decision by a federal appeals court this week could have a dramatic impact on the marketing of prescription drugs in America, potentially affecting patient care and everything from TV advertising to future government prosecutions which, in the past, had yielded billions of dollars in settlements, doctors and attorneys said Tuesday.

"This risks taking us back to an era when people could promote snake oil without restrictions – a situation I would hate to see," said Richard Deyo, MD, a professor of family medicine at Oregon Health and Science University.

Citizens United Redux

However, others say the ruling by a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan is a victory for free speech, one that could become the drug industry equivalent of Citizens United, the 2010 U.S. Supreme Court decision that gave corporations and unions the right to spend unlimited sums on political ads.

Like the Citizens United case, the ruling Tuesday by the prestigious U.S. Court of Appeals for the Second Circuit in New York, involved the right of commercial free speech, applying it to the complicated world of pharmaceutical industry promotion of prescription drugs.

How wide-ranging the decision becomes likely will depend on whether it gets to the U.S. Supreme Court, attorneys said.

Once the Food and Drug Administration approves a drug, physicians are free to prescribe that drug as they wish -- but the drug makers can only market the drug for the FDA-approved marketing indication.

The case involves Alfred Caronia, a sales representative with Orphan Medical who was criminally prosecuted for making off-label promotional statements about Xyrem, a drug approved in 2002 to treat narcolepsy patients with a condition known as cataplexy. Cataplexy involves weak or paralyzed muscles.

The FDA required a black box warning on the drug stating that its safety and effectiveness had not been established in people under the age of 16. The active ingredient in Xyrem is GHB, is a powerful medication that acts on the central nervous system and also is known as the "date rape" drug.

In 2005, the federal government began investigating Orphan Medical for its alleged off-label promotion of Xyrem.

In a taped conversation Caronia had with a doctor who was cooperating with the government, he said the drug could be used for other muscle conditions such as fibromyalgia, restless leg syndrome, and Parkinson's.

He also said it could be used in patients under 16.

Caronia had claimed that his off-label promotion was constitutionally protected free speech, saying the First Amendment does not permit the government to prohibit or criminalize a drug company's truthful, nonmisleading off-label promotion to doctors.

Protected Speech

The appeals court essentially agreed, noting that Caronia never conspired to put false or deficient labeling on the drug.

"The government clearly prosecuted Caronia for his words – for his speech," the court said.
"This could be a watershed moment for the pharmaceutical industry," said Michael Buchanan, a former federal prosecutor who now works for a New York law firm that represents drug companies.

He said the decision will be good for consumers and doctors because it will allow drug companies to disseminate more information about their products, allowing for more informed decision-making.

It is likely the decision, if upheld, will make it much more difficult for the Department of Justice to bring cases against drug companies for off-label drug promotion, he said.

Over the last decade or so, the Justice Department has obtained billions of dollars from drug companies after accusing them of promoting their products for off-label uses.

In its most recent prosecution in July, the department obtained a record $3 billion settlement from GlaxoSmithKline for its marketing of several drugs, including Wellbutrin, Paxil, and Advair.

Tamara Piety, an expert on commercial speech and the First Amendment and a professor of law at the University of Tulsa, said that if the decision is upheld by the Supreme Court it could open the doors to off-label television advertising of drugs. Piety predicted that a majority of the Supreme Court Justices would be sympathetic to the ruling.

She said the pharmaceutical industry has been trying for years to overturn the off-label marketing prohibition.

"It looks like they finally succeeded," she said.

Steven Nissen, MD, a cardiologist with the Cleveland Clinic, said the decision was short-sighted and could result in patients being exposed to unnecessary risks.

"Off-label promotion is not about free speech, it is the medical equivalent of yelling fire in a crowded auditorium." he said.

Andrew Kolodny, MD, a New York psychiatrist who has been trying to reform the use of narcotic painkillers in the U.S., said the decision was terrible for public health.

"A large portion of Americans already are taking drugs with serious risks that outweigh the benefits," he said
.
"This is going to get much worse," Kolodny said. "It's a safe bet that health outcomes will decline from medication side effects, while spending on prescription drugs will continue to rise."

Ed Silverman, who operates the popular Pharmalot blog, said drug companies had been pushing off-label promotion as a free speech issue for years.

"It (the decision) is vindication for the pharmaceutical industry," he said.

PhRMA Applauds

In a statement, the Pharmaceutical and Research Manufacturers of America said it was pleased that the court found that the FDA's ability to regulate communication about medicine is circumscribed by the First Amendment.

"PhRMA believes that truthful and nonmisleading communication between biopharmaceutical companies and healthcare professionals is good for patients, because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments," PhRMA spokesman Matthew Bennett said in a statement.

Sidney Wolfe, MD, with the watchdog group Public Citizen, said the decision will further weaken the FDA.
Caronia was accused of conspiring with a psychiatrist who was a hired drug company speaker.

In overturning Caronia's conviction, the appeals court cited a 2011 U.S. Supreme Court decision involving a Vermont law that said "speech in the aid of pharmaceutical marketing ..." is a form of expression protected by the First Amendment. The law had barred drug companies from obtaining and using prescriber information for marketing purposes when a range of others such as private and academic researchers could acquire the information.

The Court of Appeals said the government's view of the law essentially legalized off-label prescribing but prohibited the free flow of information about that.

Arnold Friede, a former FDA and drug company attorney, said the next step may be for the government to ask the entire appeals court to rehear the case.

Tuesday, November 27, 2012

Q: When is too much exercise not a good thing? A: When it concerns preserving the integrity of your knees.

Moderate Activity May Be Key to Saving Knees



CHICAGO – Too much exercise led to early degenerative cartilage changes in the knee in healthy people and in those at risk for osteoarthritis, according to an MRI-based study.

Over a 4-year period, 205 individuals who exercised at various intensity levels underwent MR imaging that showed significant T2 progression, suggestive of accelerated cartilage matrix biochemical degeneration (P<0.05), said Wilson Lin, a research fellow at the University of California San Francisco, during a presentation at the Radiological Society of North America meeting.

"This study seems to suggest that people should do things in moderation," Lin said during an RSNA press briefing. "You want to exercise the knee, but you don't want to stress the knee in such a way that would be detrimental. If [people] wanted to run marathons and work out several times a week, I would present them with the evidence that this could be harmful."

The relationship between physical activity and the evolution of osteoarthritis is unclear, but cross-sectional studies have shown that very low and high levels of exercise may be associated with higher cartilage T2 relaxation times compared with mild levels of exercise.

Lin's group enrolled people from two cohorts -- incidence and normal -- of the Osteoarthritis Initiative Incidence. Participants' ages ranged from 45 to 60 and the body mass indices ranged from 19 kg/m2 to 27 kg/m2.

None of the participants had knee pain at baseline (zero score on the Western Ontario and McMaster Universities Arthritis Index), and a Kellgren-Lawrence score of less than 2 in the right knee at baseline.

Physical activity was scored using the Physical Activity Scale for the Elderly (PASE) questionnaire, which was averaged over a 4-year time period and categorized into tertiles. The rigorous activity tertile generally consisted of 1 hour of vigorous physical activity, three times or more per week.

T2 values of articular cartilage were measured at the patella, medial/lateral femur and medial/lateral tibia of the right knee in multi-echo spin-echo sequences at baseline, 2 years, and 4 years.

All compartments in the knee showed significant T2 progression over the study period, Lin said.

The authors also reported that T2 progression was higher in the highest tertile on PASE than in the midtertile at the medial tibia (2.8 versus 2.0, P=0.04) and the patella (4.1 versus 3.1, P=0.02). The average T2 of all knee compartments combined was 2.5 versus 2.0 (P=0.03) for highest PASE tertile compared with midtertile.

T2 progression was also higher in the lowest tertile than in the midtertile in all compartments, but results were not significant. "We did observe a trend to higher T2 relaxation times in the most sedentary individuals (about 2.4) but that did not reach statistical significance (P<0.10)," co-author Thomas Link, MD, PhD, told MedPage Today.

Link also told MedPage Today that according to previous studies, people who exceed 10,000 steps a day based on a pedometer appeared to be at risk of acceleration progression of cartilage damage. However, he said there was no science to determine the number of steps that would be considered sedentary.

Link noted that study did involve individuals who were at high risk for knee osteoarthritis because of family history, obesity, or a history of knee injury or replacement surgery.

He suggested that people should use correct footwear and attend classes that emphasize exercise safety.
"This shows that titrating physical activity may be important, not just being physically active," said Candice Johnstone, MD, who moderated the RSNA press briefing. "Being super-aggressive in exercise may be worse than moderate exercise such as walking."

"I was not surprised by these results. This is more like common sense," added Johnstone, who is from the Medical College of Wisconsin in Milwaukee. "This adds to information people have to use to design their own exercise program."

The Osteoarthritis Initiative Incidence is sponsored by NIH.
Lin reported no conflicts of interest. Link disclosed commercial relationships with GE Healthcare.
Johnstone reported no conflicts of interest.




Primary source: Radiological Society of North America
Source reference:
Lin W, et al "High levels of physical activity are associated with greater cartilage degeneration over a period of 4 years as assessed with T2 relaxation time measurements – 3T MRI data from the Osteoarthritis Initiative" RSNA 2012; Abstract LL-MKS-SU1B.

Wednesday, November 21, 2012

A new study demonstrates better treatment outcomes for those older patients who have a positive outlook on aging and are trying to rehabilitate from a disabling injury.

Positive Outlook on Aging Helps Seniors Heal

Older patients with positive attitudes on aging may be more likely to fully recover from severe disability compared with those who can't see the bright side of life, researchers found

A positive stereotype about aging was associated with a 44% greater likelihood of recovery from severe disability versus negative stereotypes (95% CI 1.01 to 2.06, P=0.04), according to Becca Levy, PhD, from the Yale School of Public Health, and colleagues.

Holding positive stereotypes in older age was also significantly associated with a slower rate of decline in activities of daily living (P=0.001), they wrote in a research letter in the Journal of the American Medical Association online.

"Further research is needed to determine whether interventions to promote positive age stereotypes could extend independent living in later life," the authors noted.

The researchers sampled patients through the Precipitating Events Project study and included 598 mostly female patients (63.3%), with an average age of 79, who belonged to a Connecticut health plan. All participants lived in a community, were nondisabled, and experienced at least 1 month of disability from active daily life during the follow-up period.

The participants were interviewed monthly for up to 129 months and filled out home-based assessments every 18 months over 10 years.

The researchers established age stereotypes by asking participants for five terms or phrases they associated with older individuals and coding those descriptors on a five-point scale, with 1 being most negative (such as decrepit) and 5 being most positive (such as spry). The participants scored a mean 2.12 on this scale.

Participants' severity of disability was based on the number of activities of daily living compromised by disability, including bathing, dressing, transferring, and walking. Three or four compromised activities were considered severely disabled; mild to severe disability required assistance with one to two activities, and mild to no disability required no assistance with activities of daily life.

The researchers grouped patients on whether they held positive or negative age stereotypes and compared rates of recovery from severe or mild injury to no or mild disability. Patients between groups were well-matched for age, sex, nonwhite ethnicity, frailty, education, chronic conditions, mental status, depression, and whether or not they lived alone. The nature of the disabling events was not described.

Patients were significantly more likely to recover from any state of injury to either no or mild disability if they fit positive age stereotypes, including from severe disability to no disability, severe disability to mild disability (HR 1.23, 95% CI 1.03 to 1.46, P=0.02), and mild disability to no disability (HR 1.15, 95% CI 1.02 to 1.29, P=0.02).

The researchers also noted that the positive age-stereotyped patients "showed an advantage in the absolute risk increase percentages" in likelihood of recovery, in addition to "a significantly slower rate of [activities of daily life] decline."

Study limitations included recruitment from a single community and an undersampling of black patients.

The study was funded by grants from NIH and Yale and an investigator award from the Patrick and Catherine Weldon Donaghue Medical Research Foundation.
The authors declared no conflicts of interest.

Tuesday, November 13, 2012

HealthDay Report: The longer and more chronic your sciatic pain, the less likely steroid injections are going to help. Outside of giving your body a chance to heal itself from acute sciatica, steroid injections may not address the cause at all.

 http://consumer.healthday.com/img/healthday.jpg

Steroid Shots for Sciatica: Benefits Only Brief, Analysis Finds

Patients should discuss risks with their doctor, researcher says

By Kathleen Doheny, HealthDay Reporter
 
 

MONDAY, Nov. 12 (HealthDay News) -- Spinal steroid injections -- the type involved in the current fungal meningitis outbreak in the United States -- provide only short-term relief for sciatica-related leg and back pain, according to a new analysis.

Sciatica, a common type of low back pain, is characterized by intense pain shooting down one leg, along with tingling and numbness, as a result of injury or pressure on the sciatic nerve.

Epidural steroid treatments -- injections into the joint spaces of the spine -- have been used to treat back pain for a half-century, but consistent guidelines for their use are nonexistent, according to the new study, which was published Nov. 13 in the journal Annals of Internal Medicine.

In the new analysis, researchers analyzed 23 clinical trials involving more than 3,100 patients; the trials compared steroid injections to other treatments. Researchers had followed patients for a year or longer, gauging pain relief at various points.

"The review showed that [epidural injections] offered only small, short-term improvement in pain and disability for people with sciatica and had no long-term effect," said study co-author Dr. Chris Maher, professor of physiotherapy at the School of Public Health at the University of Sydney in Australia.

At two weeks and three months after treatment, 10 trials showed leg-pain relief and 14 reported improvements in disability. But after a year or more, no differences were found in leg pain, back pain or disability for those given injections compared to those given a placebo.

"Given that the treatment effect is likely to be small and short term, patients with sciatica should discuss the potential risks involved in [steroid injections] with their doctor before agreeing to the procedure," said Maher, who also is director of the George Institute for Global Health, in Sydney.

The results echo some of the findings of another study, published earlier this year, that concluded that after six months, epidural steroid injections were no better than the anti-inflammatory drug Enbrel (etanercept) or an injection of anesthetic and saline.

Dr. Steven Cohen, professor of anesthesiology and critical care medicine at Johns Hopkins School of Medicine in Baltimore and director of pain research at Walter Reed National Military Medical Center, said the findings shouldn't rule out use of epidural steroid treatment.

"It is likely that, at least in some people, epidurals may decrease the likelihood that they will need surgery -- not because they last so long, but because they decrease pain enough for your body to heal itself and/or prevent those deleterious changes from occurring in the nervous system," Cohen said.

Cohen was a researcher on the study comparing the injections with Enbrel, which was published in April in the Annals of Internal Medicine.

Many factors play into the injections' effectiveness, he said. One is the duration of pain. The longer a patient has had the pain, the less responsive treatment tends to be, not only to injections but also to other therapies.

Risks to patients were not examined, Maher said. These remain a concern, especially since tainted steroid injections have killed 32 people and sickened 438 to date since the fungal meningitis outbreak came to light in September. The contaminated drugs were traced to a compounding pharmacy -- now shut down -- that produced drugs to meet the needs of specific patients. Such specialty pharmacies are regulated by state boards, not the U.S. Food and Drug Administration.

Despite that outbreak, epidural injections for back pain are extremely safe, Cohen said, and ''certainly safer than commonly used alternatives such as surgery or narcotics."

"When you examine alternatives for sciatica, no treatment is very reliable or effective," he said, adding that doctors should be more selective in choosing which patients could benefit from the injections.

Dr. Roger Chou, associate professor of internal medicine at Oregon Health & Science University, in Portland, agreed.

"[This new review] underscores the importance of performing epidural steroid injections judiciously, in patients who have clear indications for it, especially in light of the fungal meningitis outbreak," Chou said. There is no evidence that the injections work, for instance, in those with low back pain without sciatica.

Monday, November 5, 2012

In a story in the Baltimore Sun, conservative treatments for back pain might be first considered over invasive procedures in light of meningitis outbreak.

Meningitis outbreak brings attention to treatment of back pain

Some argue people too dependent on drugs, surgery

Dr. Alan K. Sokoloff
Dr. Alan K. Sokoloff, chiropractor, treats patient Naomi Morgan. (Amy Davis, Baltimore Sun / October 31, 2012)


Naomi Morgan reached her limit when her doctor recommended a third surgery for chronic back pain.
Tired of being cut open only to have the pain return, Morgan, a 65-year-old nursing assistant, began looking for a less invasive and hopefully more effective way to treat her ailment, which she thinks started from lifting patients or moving furniture. She turned to a chiropractor, whom Morgan credits for helping her manage her back pain for the past 21 years with stretching, realignments and other treatments.

As the country continues to reel from a fungal meningitis outbreak — linked to a tainted steroid used to treat back pain — that has sickened 386 people in 19 states and killed 28, the medical industry is debating again about how back pain is treated.

The outbreak revived old arguments about whether back pain sufferers have become too dependent on drugs and surgeries as quick cures — and whether these treatments even work in the long run.

Back pain is the second most common neurological ailment in the United States behind headaches, according to the National Institute of Neurological Disorders and Stroke. More than a quarter of adults experienced lower back pain in the last three months, according to a recent report by the National Center for Health Statistics.

"A lot of times primary care doctors, or even patients, get into certain patterns where, if it hurts, they go the extreme route first instead of trying something natural and more conservative," said Dr. Alan Sokoloff, a Glen Burnie chiropractor who treats Morgan.

The American Academy of Pain Medicine promotes a multi-disciplinary approach and agrees that drugs should be used after other, less invasive methods are given a shot. But pain doctors also say that medications shouldn't be scapegoated and that drugs can be the best treatment for some patients.

"Too often we look at problems in a dichotomous way," said Dr. Lynn Webster, a Salt Lake City anesthesiologist and president-elect of the pain medicine group. "There is not either or. There is a spectrum of back pain problems that range from minimal pain to those who are totally incapacitated and can't walk. They may all require different treatments."

Shots of the steroid preservative-free methylprednisolone acetate, which has been linked to the meningitis outbreak, has become a common way to treat the pain. Roughly 14,000 people may have received contaminated shots of the steroid, which came from the New England Compounding Center in Framingham, Mass. In Maryland, 22 people have been sickened and one died.

Pain doctors around the country have heard from patients afraid to get the steroid shots, Webster said. Many may switch to oral pain killers. While he said the fear is justified, the medical industry has to be careful of moving too far to the extreme, he said.

The chiropractic industry is using the outbreak to advocate for more conservative, less invasive approaches to treating back pain, including yoga, acupuncture and, of course, chiropractic care.

The Foundation for Chiropractic Progress in California issued a position paper after the outbreak criticizing what it calls an overuse of drugs to treat back pain. The group said the use of drugs creates addicts and masks pain rather than treating underlying conditions.

"While living in a society where we expect to live pain-free, America may now be convinced that there needs to be a safer way to address back pain, with chiropractic care becoming a preferred option," the foundation's paper read.

In a phone interview, Dr. Gerard Clum, a foundation spokesman, said the use of drugs among doctors is inconsistent.

"There is a spectrum of behavior," Clum said. "There are some physicians that will hold surgery and epidural injections as the last resort and others who jump to it very quickly."

The type of doctor a patient sees may determine what treatment is recommended for back pain. If your primary care physician sends you to an orthopedic surgeon you may be more likely to end up in surgery, for example.

Surgeons say most of their patients with back pain don't end up on the operating table.

Patients with pain limited to the back can get physical therapy and use muscle relaxers such as Bengay, said Dr. Raj Rao, a spokesman for the American Academy of Orthopaedic Surgeons. Most patients just need to have patience and give the pain time to go away.

Surgery is more common for patients who feel pain in the legs or buttocks as well as the back, Rao said. That is a sign of nerve compression. But even these patients can be treated without surgery, he said.

"Most well-trained surgeons will exhaust non-operative measures before turning to surgery," Rao said.

Some Baltimore-area chiropractors said they've noticed more referrals from primary care doctors since the meningitis outbreak. They also are fielding more questions about the safety of steroid injections.

Chiropractor Adam Fidel, president of the Maryland Chiropractors Association, said he has had more patients want to try other options before moving to steroid injections or other invasive procedures.

"I think more people are more comfortable with going to a chiropractor than ever before," Fidel said. "And more primary care physicians are recommending them."

But even chiropractors said there is room for drugs in treating back pain.

Many chiropractors work with pain management doctors. White Marsh chiropractor Timothy Gober said people shouldn't write off drugs for treating back pain. The meningitis outbreak is an anomaly, he said.

Gober said he believes in starting with conservative treatment options and using pain killers if needed.
Sometimes he'll send a patient to get a steroid injection so he can perform a realignment without discomfort for the patient.

"A lot of times doctors try to fit patients in a box," Gabor said. "We try to see what is best for patients."

Morgan, the nursing assistant from Glen Burnie, said she still feels some aches and pains despite the treatments prescribed by her chiropractor. It's just something she has to deal with as she gets older. But her condition is better than it once was, she said. And she is not opposed to other treatment options, such as cortisone shots, if her condition ever worsened.

But she's almost sure she'll never get surgery again.

"The only way I would ever have surgery again is if I wasn't able to move my legs, back or anything else," she said. "I'd have to be in pretty bad condition."