The new pills contain the highly addictive painkiller hydrocodone, packing up to 10 times the amount of the drug as existing medications such as Vicodin. Four companies have begun patient testing, and one of them — Zogenix of San Diego — plans to apply early next year to begin marketing its product, Zohydro.

If approved, it would mark the first time patients could legally buy pure hydrocodone. Existing products combine the drug with nonaddictive painkillers such as acetaminophen.

Critics say they are especially worried about Zohydro, a timed-release drug meant for managing moderate to severe pain, because abusers could crush it to release an intense, immediate high.

“I have a big concern that this could be the next OxyContin,” said April Rovero, president of the National Coalition Against Prescription Drug Abuse. “We just don’t need this on the market.”

OxyContin, introduced in 1995 by Purdue Pharma of Stamford, Conn., was designed to manage pain with a formula that dribbled one dose of oxycodone over many hours.

Abusers quickly discovered they could defeat the timed-release feature by crushing the pills. Purdue Pharma changed the formula to make OxyContin more tamper-resistant, but addicts have moved onto generic oxycodone and other drugs that do not have a timed-release feature.

Oxycodone is now the most-abused medicine in the United States, with hydrocodone second, according to the Drug Enforcement Administration’s annual count of drug seizures sent to police drug labs for analysis.

The latest drug tests come as more pharmaceutical companies are getting into the $10 billion-a-year legal market for powerful — and addictive — opiate narcotics.

“It’s like the wild west,” said Peter Jackson, co-founder of Advocates for the Reform of Prescription Opioids. “The whole supply-side system is set up to perpetuate this massive unloading of opioid narcotics on the American public.”

The pharmaceutical firms say the new hydrocodone drugs give doctors another tool to try on patients in legitimate pain, part of a constant search for better painkillers to treat the aging U.S. population.

“Sometimes you circulate a patient between various opioids, and some may have a better effect than others,” said Karsten Lindhardt, chief executive of Denmark-based Egalet, which is testing its own pure hydrocodone product.

The companies say a pure hydrocodone pill would avoid liver problems linked to high doses of acetaminophen, an ingredient in products like Vicodin. They also say patients will be more closely supervised because, by law, they will have to return to their doctors each time they need more pills. Prescriptions for the weaker, hydrocodone-acetaminophen products now on the market can be refilled up to five times.

Zogenix has completed three rounds of patient testing, and last week it announced it had held a final meeting with Food and Drug Administration officials to talk about its upcoming drug application. It plans to file the application in early 2012 and have Zohydro on the market by early 2013.

Purdue Pharma and Cephalon, a Frazer, Pa.-based unit of Israel-based Teva Pharmaceuticals, are conducting late-stage trials of their own hydrocodone drugs, according to documents filed with federal regulators. In May, Purdue Pharma received a patent applying extended-release technology to hydrocodone. Neither company would comment on its plans.

Meanwhile, Egalet has finished the most preliminary stages of testing aimed at determining the basic safety of a drug. The firm could have a product on the market as early as 2015 but wants to see how the other companies fare with the FDA before deciding whether to move forward, Lindhardt said.

Critics say they are troubled because of the dark side that has accompanied the boom in sales of narcotic painkillers: Murders, pharmacy robberies and millions of dollars lost by hospitals that must treat overdose victims.

Thousands of legitimate pain patients are becoming addicted to powerful prescription painkillers, they say, in addition to the thousands more who abuse the prescription drugs.

Prescription painkillers led to the deaths of almost 15,000 people in 2008, more than triple the 4,000 deaths in 1999, the Centers for Disease Control and Prevention reported last month.

Emergency room visits related to hydrocodone abuse have shot from 19,221 in 2000 to 86,258 in 2009, according to data compiled by the Drug Enforcement Administration. In Florida alone, hydrocodone caused 910 deaths and contributed to 1,803 others between 2003 and 2007.

Hydrocodone belongs to family of drugs known as opiates or opioids because they are chemically similar to opium. They include morphine, heroin, oxycodone, codeine, methadone and hydromorphone.

Opiates block pain but also unleash intense feelings of well-being and can create physical dependence. The withdrawal symptoms are also intense, with users complaining of cramps, diarrhea, muddled thinking, nausea and vomiting.

After a while, opiates stop working, forcing users to take stronger doses or to try slightly different chemicals.

“You’ve got a person on your product for life, and a doctor’s got a patient who’s never going to miss an appointment, because if they did and they didn’t get their prescription, they would feel very sick,” said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. “It’s a terrific business model, and that’s what these companies want to get in on.”

Under pressure from the government, Purdue Pharma last year debuted a new OxyContin pill formula that “squishes” instead of crumbling when someone tries to crush it.

But Zogenix, whose drug is time-released but crushable, says there is not enough evidence to show that such tamper-resistant reformulations thwart abuse.

“Provided sufficient effort, all formulations currently available can be overcome,” Zogenix said in a written response to questions by The Associated Press.

At a conference for investors New York on Nov. 29, Zogenix chief executive Roger Hawley said the FDA was not pressuring Zogenix to put an abuse deterrent in Zohydro.

“We would certainly consider later launching an abuse-deterrent form, but right now we believe the priority of safer hydrocodone — that is, without acetaminophen — is a key priority for the FDA,” Hawley said.

FDA spokeswoman Erica Jefferson said the agency would not comment on its discussions with drug companies, citing the need to protect trade secrets.

Drug control advocates say they’re worried the U.S. government is too lax about controlling addictive pain medications. The United States consumes 99 percent of the world’s hydrocodone and 83 percent of its oxycodone, according to a 2008 study by the International Narcotics Control Board.

One 41-year-old loophole in particular has fed the current problem with hydrocodone abuse, critics say. The federal Controlled Substances Act, passed in 1970, puts fewer controls on combination pills containing hydrocodone and another painkiller than it does on the equivalent oxycodone products.

A Vicodin prescription can be refilled five times, for example, while a Percocet prescription can only be filled once.

The Drug Enforcement Administration and Food and Drug Administration have been studying whether to close this loophole since 1999 but have made no decision. Congress is now considering a bill that would force the agencies to tighten the controls.

“This is a problem that is fundamentally an oversupply problem,” said Jackson, the drug-control advocate. “The FDA has kind of opened the floodgates, and they refuse to recognize the mistakes made in the past.”

Pure hydrocodone falls into the stricter drug-control category than hydrocodone-acetaminophen medications, meaning patients would have to go to their doctors for a new prescription each time they needed more pills. But Jackson said that’s no guarantee against abuse, noting that dozens of unscrupulous doctors have been caught churning out prescriptions in so-called “pill mills.”

The Drug Enforcement Administration, which enforces controls on prescription medicines along with the FDA, said it could not comment on drugs that have not yet been approved for sale.

However, Zogenix has acknowledged the abuse issue could become a liability.

“Illicit use and abuse of hydrocodone is well documented,” it said in a filing with the Securities and Exchange Commission in September. “Thus, the regulatory approval process and the marketing of Zohydro may generate public controversy that may adversely affect regulatory approval and market acceptance of Zohydro.”

Technorati Tags: hydrocodone, Oxycontin, Zogenix, Zohydro

According to HAAD, it has received numerous reports involving the abuse of the drug. “HAAD has received reports of theft (of Pregabalin) from pharmacies as well as pharmacists being threatened to provide Pregabalin. We advise all pharmacies to report promptly to police as well as notify HAAD Narcotics Officer (call 02-4193375) of any such incidents,” a recent circular issued by the authority to healthcare centres and pharmacies warned.

According to the authority, the drug is used for the treatment of neuropathic and generalised anxiety disorder. Evidence shows that it produces some pharmacological effects characterised by anxiolytics, and has been abused for its positive psychic effects (euphoria). “We remind you of the Prescriptions Only Medicines (MOP) status of Pregabalin, which must only be dispensed against a valid prescription,” the authority warned pharmacists. HAAD further reminded the prescription supply of the drug was limited to 30 days of treatment only and for all dispensed, pharmacies must retain the original prescriptions.

According to pharmacies in the capital, they received the circular on June 15. “Here we have the circular displayed. We never sell drugs without a valid prescription. We have to abide by the health authority rules and regulations,” said a pharmacist at Alya Pharmacy.

A pharmacist at another pharmacy said they never had an incident where people came for the drug without a valid prescription, and nor were threatened for not selling the drug without a prescription.

He said: “We are very strict about selling drugs without a prescription. And so far, we have had no problem where people come and force us to sell them medicine without a prescription. Most of our customers are blue-collared Asian workers who cannot afford to invite a problem.”

Technorati Tags: generalised anxiety disorder, pain relief drug, Pregabalin

“The available evidence just suggests that it doesn’t work,” study author Dr. Paul Michael Peloso told Reuters Health. If patients have neck pain, “they and their physicians should be discussing other therapies,” Peloso added.

The ingredient in Botox, called botulinum toxin, is used to treat a range of conditions, including wrinkles, migraines, and excessive sweating. Botox is just one of several brand names for the drug, which is given through injections. None of the brands has been approved by the Food and Drug Administration to treat neck pain, but doctors may use the drug “off-label” for that purpose.

A recent report from the Institute of Medicine suggested that chronic pain, including neck pain, costs the United States more than $600 billion each year and affects about four in 10 adults (see Reuters story of June 29, 2011).

Peloso, the head of clinical research at the drug company Merck in Rahway, New Jersey, said doctors might consider using the Botox ingredient for neck pain after other more common treatments, including pain relief drugs like Tylenol and aspirin or exercises, haven’t worked.

Each injection typically costs a few hundred dollars, and patients may need repeat injections every few months for the drug to have a continued effect.

The new review analyzed the combined results of nine studies that tested botulinum toxin A, sold as Botox by Allergan, in people with new or chronic neck pain and related headaches.

Those studies compared the effect of botulinum toxin with drug-free sham injections or other pain treatments, using patient reports or doctor observations of pain, physical abilities, and quality of life. Altogether the studies involved 503 patients, including 272 who received injections of the drug.

Peloso and his colleagues noted that some of the studies had limitations, for example, it wasn’t clear how some had split the patients up into Botox and not-Botox groups, or researchers hadn’t kept treatment types hidden from patients or from those who measured their symptoms.

But taken together, the studies suggested Botox had done nothing to help relieve neck pain or related headaches, either alone or when added to exercise programs or other medications, when researchers reassessed patients at four weeks and six months after injections.

In addition, people given botulinum toxin were more likely to have a side effect, including soreness or flu-like symptoms, than those not given the drug.

The researchers concluded that almost all of the studies showed that any possible benefits were not worth the potential harms. Their findings are presented in the Cochrane Library, a publication of the Cochrane Collaboration, an international organization that evaluates medical research.

A company spokesperson told Reuters Health in an email that “Allergan does not have clinical programs evaluating the efficacy and safety of our botulinum toxin products in patients with sub acute or chronic neck pain,” but that Botox is indicated to treat “cervical dystonia,” in which neck muscles contract involuntarily, and neck pain linked to the condition. She also pointed out that the review didn’t focus only on Botox-brand treatments.

Peloso said that while some evidence suggests injections of steroids or anesthetics might help people with neck pain, the best pain-relief choice right now seems to be exercises that strengthen muscles and improve range of motion.

However, he pointed out, “The problem is as you would guess for exercise that it’s just not as simple as a one-time visit” or a daily drug, one reason his team was interested to see if Botox might have some benefit.

He said that companies have little incentive to study treatments for neck pain, which can be caused by anything from overuse of neck muscles to diseases such as arthritis and gets more common with age. Peloso added that his company does not make a Botox competitor, although it does market pain products that could be used for neck pain.

Read more: http://www.foxnews.com/health/2011/07/06/does-botox-help-neck-pain/#ixzz1RVroJrBt

Technorati Tags: Botox, neck pain relief, pain relief drugs

Remoxy is an investigational abuse-resistant, long acting, oral painkiller containing narcotic oxycodone intended for moderate-to-severe chronic pain. It is an encapsulated, water insoluble, twice-daily oral formulation.

Commenting on the rejection, Pfizer said it is working to evaluate the issues and plans to have further discussions with FDA around them.

Olivier Brandicourt, Pfizer President and General Manager, Primary Care said, “Pfizer is working to understand and address the issues in the FDA Complete Response Letter. Pain is an important strategic disease area for Pfizer. We share the concern about misuse and abuse of opioid medicines and are committed to being part of the solution to address this important public health and safety issue.”

James Brown, president and CEO of Durect noted that Pfizer has an experienced team of scientists dedicated to resolving the remaining issues.

Pain Therapeutics had submitted the initial new drug application for Remoxy in June 2008, however, it was rejected by FDA in December that year, requesting for more data. Later, Tennessee based King Pharma assumed the control of the drug and filed a resubmission in December 2010, further to an abuse liability study. When Pfizer acquired King Pharma, in February 2011, it received the rights to Remoxy.

In April end, Pain Therapeutics announced that an abuse liability study of Remoxy met all primary endpoints. The study recorded that patients on Remoxy showed lower liking for the drug compared with standard care oxycodone and placebo.

DRRX shares are trading down 30.42 percent at $2.16 on a volume of 1.29 million shares, while PTIE is down 39.50 percent at $5.5701 on a volume of 6.77 million shares.

PFE shares are currently trading at $20.28, down 1.84 percent on a volume of 12.44 million shares.

Technorati Tags: FDA, Pain Killer, Pfizer, Remoxy

Only 31 percent of people in the study knew that Tylenol contains acetaminophen, while 75 percent of people knew that Bayer contained aspirin and 47 percent of people knew that Motrin contains ibuprofen, the study said.

Nineteen percent of people in the study knew that Aleve contains naproxen sodium, and 19 percent of people knew Advil contains ibuprofen, according to researchers from the Feinberg School of Medicine at Northwestern University.

Acetaminophen overdose is the leading cause of liver failure among adolescents and young adults — some accidental, some intentional, said Dr. Lee M. Sanders, an associate professor of pediatrics at University of Miami Miller School of Medicine, who was not involved with the study. The big concern is that people are taking multiple medications that contain acetaminophen without realizing that they all contain the ingredient, he said

The study was published today (May 3) in the American Journal of Preventive Medicine.

Participants’ knowledge

Researchers conducted focus groups with 45 English-speaking adults in two cities to test their knowledge and use of over-the-counter painkillers. Forty-four percent of the people in the groups read at or below a sixth-grade level.

However, the population represents low-income and low-educated people who are at the greatest risk for medication safety issues, Sanders said.

Researchers found that only 41 percent of people in the study read the ingredients on the drug labels. They also learned that some of the ingredients are confusing to people, since, for example, acetaminophen is also called “APAP” on some drug labels.

Labeling suggestions

While the study’s findings are alarming, they are not surprising, Sanders said. Previous research by Sanders shows that there is similar confusion among the parents of young children who use liquid over-the-counter medication for their children.

It’s not consumers’ fault that the labels are so confusing, Sanders said.

“I think the marketing and labeling of these products is very confusing,” Sanders told MyHealthNewsDaily. “I often get called by medical colleagues (M.D.s and Ph.D.s) with questions about this.”

The study researchers propose having a symbol printed on the drug label that indicates the active ingredient, so that people can easily see what they are taking. They also suggest having clearer warnings on drug packaging for liver damage.

Pass it on: Many people do not know what’s in their over-the-counter pain relievers.

Follow MyHealthNewsDaily staff writer Amanda Chan on Twitter @AmandaLChan.

This story was provided by MyHealthNewsDaily, a sister site to LiveScience.

Technorati Tags: Naproxen, over-the-counter medication, pain relievers, painkillers

South Korean researchers used X-rays to assess the severity of knee osteoarthritis in 660 men and women, aged 65 and older. The patients were also evaluated for the severity of their symptoms and for depression.

As expected, levels of pain were higher in patients whose X-rays showed greater joint damage. However, the researchers also found that depression was associated with an increase in pain in patients with mild to moderate knee osteoarthritis, even when significant joint damage was not evident in the X-ray image.

The findings are published in the March 16 issue of the Journal of Bone and Joint Surgery.

“Knee osteoarthritis is a common cause of pain and impairment in older adults. Often, the level of arthritic symptoms reported by patients is much more severe than what is represented by X-rays, which can make it difficult for the doctor to treat,” study author Dr. Tae Kyun Kim, director of the division of knee surgery and sports medicine at Seoul National University Bundang Hospital’s Joint Reconstruction Center, said in a journal news release.

“The results of this study indicate that depression can play a major role in the way patients experience the symptoms of knee arthritis, and that even when X-rays show the arthritis is not severe, patients with depression may report significant pain,” Kim said.

“The relationship between pain and depression suggests that both should be considered by physicians when treating patients with knee osteoarthritis, particularly in those with X-rays not indicating severe damage to the joint,” Kim added.

Kim also noted that some patients with knee osteoarthritis still experience pain and impaired movement after undergoing knee replacement surgery.

“Sometimes pain and disability after surgery is medically unexplained, so in these patients screening for depression might be a very good option,” Kim suggested.

According to the U.S. National Institute of Mental Health, depression often goes undiagnosed in the elderly.

Technorati Tags: Arthritis Pain, depression, knee arthritis, pain and depression

The practice of yoga has increasingly been demonstrated to improve chronic pain and other symptoms of diseases, including cancer and arthritis, said researchers at Oregon Health & Science University.

“It’s not an alternative to medication,” said study researcher James Carson, a clinical health psychologist and assistant professor at OHSU, “but the techniques in the yoga tradition really address individual needs and can decrease the psychological distress associated with pain.”

The new study was published today (Oct. 14) in the journal Pain.

Yoga gets put to the test

Carson’s study included 53 women (up to 90 percent of fibromyalgia cases are in women) whose average age was 54. Participants typically had been living with the disorder for at least a decade, and were on a stable treatment regimen of medication.

The patients were divided into two groups, and 25 of the women immediately began a Yoga of Awareness program, developed by Carson. The other 28 women were added to a waiting list for the yoga program, and were used as a control group.

The participants attended one 2-hour class per week for eight weeks, and were encouraged to do at least 20 minutes of yoga daily, five days a week, using DVDs provided by the researchers.

Using a combination of self-reported symptoms and physical measurements of tender points (sensitive areas of the body), the researchers found 77.3 percent of the participants were “at least a little better” as a result of the yoga, compared with 19.2 percent of the control group on standard therapy. In particular, half of those who had done yoga reported a 30 percent reduction in pain.

None of the yoga participants reported a significant worsening of their symptoms at the end of the two-month program, but almost 8 percent of the control group did.

To date, there has been only one other randomized, controlled trial using yoga to treat fibromyalgia, Carson said. Although the results showed overall improvements in pain symptoms, the study was smaller in scope.

Current treatments for fibromyalgia include a combination of medication, exercise and training in coping skills. The researchers said yoga therapy could be a better adjunct to drugs.

“Yoga teaches patients a set of techniques, such as breathing and meditation, in addition to incorporating poses that improve strength and balance,” Carson said.

Prescribing yoga for pain

Many doctors have already begun to prescribe yoga to patients. Carol Krucoff, a certified yoga instructor with the American Council on Exercise and author of “Healing Yoga for Neck and Shoulder Pain” (Raincoat Books, 2010), regularly works with patients who’ve been referred to her by physicians at Duke Integrative Medicine in Durham, N.C.

“Yoga is particularly helpful in a multifaceted disorder like fibromyalgia,” Krucoff said. “It offers tools to handle symptoms on many levels – physical, psychological and spiritual.”

For example, in the study, the 2-hour yoga session was divided into 40 minutes of stretching and 80 minutes of learning breathing techniques. They studied how to apply yoga principles to coping with their condition, discussed yoga with other group members, and trained in mindfulness. Mindfulness – learning how to live in the moment – may be particularly helpful for patients dealing with chronic pain, the researchers said.

“Mindfulness teaches patients to see their pain from a different perspective,” Carson told MyHealthNewsDaily. “They learn to understand that a pain flare might be happening at a particular moment, but that moment will pass.”

These techniques may have a powerful effect inside the body. Relaxation is known to cause many changes in the body, including decreased heart rate and improved breathing. Because dysregulation of the nervous system is thought to be the source of fibromyalgia symptoms, Carson hopes to study biological changes brought about by yoga teachings such as mindfulness and “healthy acceptance.”

“Yoga may be changing the way pain is processed at the neural level,” Carson said.

Although the results of his study are promising, its small size and reliance on self-reported information make it difficult to generalize the results.

Carson plans to next look at a larger group of fibromyalgia patients that includes men, and to follow-up with participants for one year to see if the benefits of yoga are more lasting.

Technorati Tags: Fibromyalgia, Fibromyalgia pain relief, yoga

University at Buffalo researchers interviewed 75 patients hospitalized for opioid detoxification and found that 31 of them said they first became addicted to legitimately prescribed painkillers.

Another 24 patients said their addiction began when they used a friend’s left-over prescription pills or stole drugs from a parent’s medicine cabinet, while the remaining 20 patients said they got hooked on street drugs.

But the study found that 92 percent of the patients said they eventually bought illegal drugs (usually heroin) because street drugs are less expensive and more effective than prescription drugs. Their reasons for continuing to use drugs included to feel “normal,” to feel “like a better person” or to ease emotional pain and stress.

“We are seeing an increase in the number of patients addicted to prescription drugs, so we wanted to better understand how they first got hooked,” study senior author Dr. Richard Blondell, a professor of family medicine, said in a University at Buffalo news release.

“This information suggests that there is a progressive nature to opioid use, and that prescription opioids can be the gateway to illicit drug addiction. It also tells us that people who use prescriptions illegally may be at greater risk for subsequent heroin use than those who use prescriptions legally.”

The study was published recently in the Journal of Addiction Medicine.

Technorati Tags: prescribed painkillers, prescription drugs, prescription medicines, Prescription Painkillers, prescription pills

The shocking question came from a respected spine surgeon tracked down by Keith Swenson, who was still in severe pain after an earlier back operation.

He didn’t know what to believe. Two other surgeons had urged more operations, different ones.

And Swenson, who’s from Howard Lake, Minn., is far from alone. Even though only a fraction of people with back pain are good candidates for surgery, complicated spine operations are on the rise.

So is the hunt for any relief.

By one recent estimate, Americans are spending a staggering $86 billion a year in care for aching backs — from MRIs to pain pills to nerve blocks to acupuncture. That research found little evidence that the population got better as the bill soared over the past decade.

“The way medicine is so Star-Treky these days, they believe something can be done,” said Dr. Charles Rosen, a spine surgeon at the University of California, Irvine.

The reality is that time often is the best antidote. Most people will experience back pain at some point, but up to 90 percent will heal on their own within weeks. In fact, for run-of-the-mill cases, doctors aren’t even supposed to do an X-ray or MRI unless the pain lingers for a month to six weeks.

Yet a study last year found nearly one in three aching Medicare patients get some kind of back scan within that first month.

Why is that a problem? Those scans can be misleading. By middle age, most people who don’t even have pain nonetheless have degeneration of their disks, those doughnut-looking shock absorbers between vertebrae. So in someone who does have pain, pinpointing that a particular black spot or bulge on a scan is the true cause is tricky.

The bigger problem: When the misery lingers, there’s no one-size-fits-most treatment.

“There are a lot of procedures going on for patients in whom we don’t have good scientific evidence that it’s going to help,” said Dr. Richard Deyo of Oregon Health and Science University in Portland, who long has studied how people fare with different options for this tough ailment.

For example, there’s a wide variety of spinal injections that aim to numb back pain, using different drugs and targeting different spots. Which one works depends on what study you read.

When the Institute of Medicine recently listed the 100 how-to-treat questions that doctors most need answered, back pain neared the top of the list.

Lots of things can cause chronic back pain, from arthritis to bone-thinning osteoporosis, which has its own controversy over whether cementing cracks in the spine really helps.

But those cushiony disks are a big reason. They naturally thin and shrink with age. Sometimes they herniate, or rupture, so the gel-like center leaks and pressures a nerve. Sometimes a vertebra slips out of alignment. Sometimes the spinal canal painfully narrows, a condition called stenosis.

The right operation can help, but specialists say only about 10 percent of people with lasting pain are candidates. More than 333,000 of the simpler decompression operations — laminectomies and diskectomies that cut away part of a bone or disk to relieve nerve pressure — were performed in 2007, the latest data compiled by the American Academy of Orthopaedic Surgeons. There were nearly 381,000 spinal fusions — more complex, riskier surgeries that bind vertebrae together with a bone graft and sometimes metal hardware.

There is some hopeful news — increasing evidence that more people should try pushing past the pain in aggressive exercise programs. Deyo calls them boot camps for back pain.

That’s what ended Swenson’s five-year pain odyssey. After a volleyball injury, scans showed he had degeneration in seven disks but one bulged in a way that doctors thought explained the pain radiating down both legs. They cut away part of that spot; it didn’t help. Neither did multiple pain-blocking options.

“Exercise is medicine, but it has to be the right exercise,” said Dave Carpenter, president of Physicians Neck & Back Clinics in Minneapolis, where Swenson finally turned.

The clinic’s rehabilitation program focuses on strengthening muscles that support the spine, and published a study showing that only three of 38 patients prescribed surgery still needed it in the 13 months after completing tailored rehab.

Swenson, now 51, said he was so debilitated that it took several months to improve, plus two years of “maintenance” conditioning. Today, he’s running a thriving gardening business near Minneapolis that ships peonies nationwide. It’s a job that requires tremendous manual labor.

“Do I have flare-ups? Yes. But now that my back is strengthened, instead of flare-ups lasting one to two months … the flare-ups last one to two days,” he said. “This form of treatment is a lifetime change.”

In New York City, Nicia Cortez wishes someone had told her of other options before her 2003 operation on a herniated disk.

“I was naive, and in severe pain. I didn’t think properly at the time,” said Cortez, who felt worse after surgery. It took her six years to work up the nerve to try again, this time a fusion that mostly relieved the pain: “I have my life back.”

Her new doctor cautions that scar tissue and altered anatomy mean each subsequent back surgery has less chance of success than the one before.

“It’s like trying to pave your driveway, layer upon layer, but at some point you replace the whole driveway. We don’t have that ability with the spine,” said Dr. Alok Sharan, spinal chief at New York’s Montefiore Medical Center.

He makes patients exhaust nonsurgical options first, knowing that about one in five who has one back operation will have another in a decade.

“Sometimes people jump to this and think it will be a cure-all, and then five years later you need another procedure. If you’re only 40, that’s a big deal,” Sharan said.

What’s the best advice? First, some types of back pain are accompanied by red flags that need immediate attention — such as numb or weak legs or urinary problems. But for most people:

_Don’t expect an X-ray, MRI or CT until a month to six weeks has passed, unless the doctor suspects a more serious problem. Following that guideline is becoming a quality-of-care measure in many organizations.

_Get back to normal activity as quickly as possible; the days of prescribed bed rest are over.

_Patients with sciatica, pain radiating down the leg, have the best outcomes from those nerve-easing decompression surgeries, Deyo stressed. California’s Rosen said three criteria determine chances of success: a scan that correlates with the pain site; the patient has some weakness; and specific pain occurs when the doctor raises and straightens the legs.

Herniated disks heal on their own over about two years, but surgery for a faster fix is reasonable in good candidates, he said.

Fusions are appropriate for far fewer patients, those with fractures, unstable or slipping spines, curvature of the spine and rare other reasons, Rosen said.

Deyo recently studied surgeries for stenosis, that painful narrowing, and found decompression surgery as effective and less risky than fusions, which are more complicated and costly.

A formal exercise program is especially effective if coupled with cognitive behavioral therapy that teaches patients to manage and function with pain, Deyo said.

What if surgery fails? Usually, it was the wrong operation or the wrong candidate, said Rosen, who sees one or two patients a week classified as having “failed back syndrome” because of multiple failed surgeries.

Always get a second opinion. Rosen, who founded the Association for Medical Ethics, also recommends asking about a doctor’s ties to companies that make spine-surgery products. That way you’ll feel assured that a recommendation to cut doesn’t come from a too-cozy relationship.

Not a good candidate? A primary care physician can be a neutral adviser in helping navigate next steps. Patients with more challenging back problems may fare better at a multidisciplinary spine center with numerous specialists — in rehab and pain management — under one roof.

“You don’t want to leave them hanging,” said Rosen.

Technorati Tags: back pain, back surgery, exercise programs, pain management, Pain pills, severe pain

What’s more alarming is that the findings suggest these more challenging operations are riskier, leading to more complications and even deaths.

“This is exactly what the health care debate has been dancing around,” said Dr. Eugene Carragee of Stanford University Medical Center.

“You have one kind of operation that could cost $20,000 and another that could cost $80,000 and there’s not good evidence the expensive one is being used appropriately in the majority of cases,” Carragee said.

Add to that the expense for patients whose problems after surgery send them back to the hospital or to a nursing home and “that’s not a trivial amount of money” for Medicare, said Carragee. He wrote an accompanying editorial in the Journal of the American Medical Association where the federally funded study appears Wednesday.

The cost to Medicare, just for the hospital charges for the three types of back surgery reviewed is about $1.65 billion a year, according to the researchers.

All the patients in the study had stenosis in their lower backs, a painful squeezing in the spine that’s most common in people over 50. The researchers compared the risks for three different types of surgery for the condition: decompression, simple fusion and complex fusion.

“All operations aren’t the same and some seem to be associated with higher complication rates than others,” said lead author Dr. Richard Deyo of Oregon Health and Science University in Portland. “It’s not necessarily true that the more aggressive surgery is better, at least in terms of safety.”

There’s little agreement about the best way to treat chronic lower back pain, and much depends on what’s causing the pain.

Patients should ask their doctors about alternatives to complicated operations, Deyo said. Could steroid injections and physical therapy be tried? Would a simple decompression procedure be as helpful as a spinal fusion and with less risk?

In a decompression procedure, the simplest method in the Medicare study, a surgeon cuts away part of the bone that’s painfully pressing on nerves. It can cost about $30,000 in hospital and surgeon fees.

For a fusion, a surgeon binds two or more vertebrae together using a bone graft, with or without plates and screws. The researchers defined a complex fusion as one involving three or more vertebrae or more than one side of the spine. Fusions cost $60,000 to $90,000.

The researchers analyzed data on more than 32,000 Medicare patients who had one of the three types of surgeries in 2007.

About 5 in 100 patients who had simple or complex fusions suffered major complications such as stroke compared to 2 in 100 with decompressions. The risk of death within 30 days after surgery was different too: 6 in 1,000 for complex fusions compared with 5 in 1,000 for simple fusions and 3 in 1,000 for decompressions.

The study didn’t address how successful the various types of surgeries were at relieving pain.

More than half the patients who had complex fusions had a simple stenosis, which usually calls for decompression alone. They did not have the curvature of the spine or a slipped vertebra — additional conditions that might suggest a fusion is needed. There’s not much evidence for doing a complex fusion for a person with simple stenosis, Carragee and other experts said.

“It certainly looks like there’s more complex surgery being done than we have very good evidence to support,” Carragee said.

Rates of complex fusions in Medicare patients rose 15-fold from 2002 to 2007, while decompressions and simple fusions declined, the study found. Although the overall procedure rate fell, hospital charges grew 40 percent.

Aggressive marketing of devices used in complex fusions is likely playing a role in the increase, Deyo said. The marketing includes ads in medical journals and lectures by surgeons on the payroll of device manufacturers.

Allegations of kickbacks to spine surgeons for using products and questionable financial arrangements to doctors as consultants have plagued the multibillion-dollar industry. One company, Medtronic Inc., reached a $40 million settlement with the U.S. Justice Department in a whistleblower case that included allegations the company paid doctors to use its spine surgery products. The company denied any wrongdoing.

Dr. Charles Rosen, a spine surgeon at the University of California, Irvine, founded the Association for Medical Ethics to nudge doctors toward scientific evidence over vested interests. Forty-nine spine surgeons have joined, pledging to refuse any type of compensation or earnings from companies for using a product.

Rosen applauded a provision in the new health care law that requires device makers and others to file annual reports to the government on their financial ties to doctors. Patients will be able to look up possible conflicts in a government database.

“Too much fusion surgery is done in this country and often for inappropriate reasons,” Rosen said. While complex fusions are needed for some conditions, he said, patients “should not hesitate to get a second opinion.”

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