Has science unearthed the Holy Grail of pain relief?

July 11, 2007

Scientists studying one of nature’s simplest organisms have helped to unravel the structure of a key molecule that controls pain in humans.

The findings - published in the top scientific journal Nature - could rapidly advance research into the next generation of painkillers for relief of chronic conditions such as migraine and backache.

Chronic pain, unlike the acute pain associated with trauma, has no apparent physiological benefit, often being referred to as the ‘disease of pain’.

Complete and lasting relief of chronic pain is rare and often the clinical goal is pain management through one or more medications.

But now researchers at The University of Manchester have examined microscopic amoeboid organisms commonly called slime moulds in a bid to gain greater insight into these pain molecules, known as ‘P2X receptors’.

“In humans, P2X receptors look identical to one another and so scientists have had difficulty understanding how they function,” said Dr Chris Thompson, who carried out the research with Professor Alan North and Dr Sam Fountain in the Faculty of Life Sciences.

“By looking at slime mould we were effectively able to turn the evolutionary clock back a billion years to see how a more primitive P2X molecule functions.”

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The team discovered that there was only a 10% similarity between human P2X and the slime mould equivalent. They were therefore able to deduce from evolutionary theory that it was these similar parts of the molecule that probably regulate pain in humans.

“It’s a big step forward in understanding how the molecule works and should make it possible to develop drugs that block the receptors’ actions,” said Dr Thompson.

“Inhibiting P2X as a potential pain-relief therapy would be the Holy Grail of rational drug design and could revolutionise the way we manage chronic pain conditions like back pain and migraine.”

The research, published in Nature today (Thursday, July 12), was funded by the Wellcome Trust, the Medical Research Council and the Lister Institute for Preventive Medicine.

Ends

Notes for editors:

In nature, the slime mould Dictyostelium exists as single-cell amoebae feeding off bacteria in the soil. When their food supply runs out they aggregate to form a ‘fruiting body’ of some 100,000 cells. Some cells become spores, while others form a stalk beneath the soil surface. These stalk cells die; they sacrifice themselves so the spores can be dispersed to new feeding grounds.

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Anesiva Announces Phase 2 Data Showing Substantial, Long-Term Pain Reductions with Adlea(TM) (formerly 4975) in Osteoarthritis of the Knee

July 2, 2007

SOUTH SAN FRANCISCO, Calif., July 2 /PRNewswire-FirstCall/ — Anesiva, Inc. today announced preliminary longer-term, follow-up results from a Phase 2 study showing that a 1mg treatment with Adlea(TM) (formerly 4975) in patients with moderate-to-severe osteoarthritis of the knee produced substantial reductions in pain that persisted for up to 12 weeks.

“The positive preliminary results from this knee pain study further strengthen our belief that Adlea will prove to be a safe and effective drug in multiple osteoarthritis indications,” said John P. McLaughlin, chief executive officer of Anesiva. “We are on-track to advance Adlea into late-stage trials in various indications this summer, including a Phase 2/3 trial for osteoarthritis of the knee.”

Fifty-five patients with osteoarthritis of the knee were randomized to receive either: (I) a single injection of 1 mg of Adlea (n=36) or (II) three stepped ascending weekly doses totaling 1 mg of Adlea (n=19). At baseline prior to treatment, approximately three quarters of the patients had moderate pain while the other quarter had severe or extreme pain. As was previously reported, patients treated with Adlea demonstrated a 61 percent reduction in mean pain intensity from baseline to week one, and the analgesic effect was sustained at all subsequent weeks to the last scheduled in-clinic assessment at week eight, at which time a 64 percent reduction in pain from baseline was reported. At week 12, pain reductions were sustained. A cohort of 50 patients showed a 65 percent reduction from baseline pain scores. Forty two percent of the patients reported “no pain,” 44 percent had “mild pain,” and only 14 percent reported “moderate” or “severe” pain. The lengthy duration of clinical benefit is consistent with the known mechanism of action that suggests treatment with Adlea administered as a single injection or stepped doses leads to pain relief durable for 12 weeks in patients suffering from moderate to severe pain due to knee osteoarthritis.

The following table summarizes the reduction in pain scores provided by the use of Adlea compared to baseline pain scores. A scale of 0-4 (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain and 4 = extreme pain) was used in the study:

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How Adlea May Address Need for Long-Duration, Well-Tolerated Pain Relief

Adlea is long-acting, with the potential to provide pain relief for weeks or months after just a single localized treatment. It is a non-opioid TRPV1 agonist with a unique mechanism of action that provides a long-lasting, localized effect on C-fibers and blocks the transmission of aching, throbbing pain caused by major surgical procedures and end-stage osteoarthritis. Because it selectively acts on pain-sensing nerve endings, Adlea does not affect other nerve fibers necessary for sensory or motor sensations, such as those needed to sense temperature or pressure. In clinical studies to date, Adlea has not had the side effects often associated with other conventional pain medications and has been shown to be well tolerated.

Pharmacokinetic studies of Adlea showed that when it is locally administered to the site of pain, there appears to be limited systemic exposure. Its short duration of systemic exposure (hours) relative to the long duration of analgesia (12 weeks) resulting from a single treatment course of Adlea is particularly important in this typically elderly and vulnerable patient population and may potentially offer a safer treatment option in the management of chronic osteoarthritis pain. Importantly, the prolonged analgesic effect resulting from a single or stepped dose, localized administration of Adlea does not seem to be associated with the systemic side effects commonly associated with NSAIDs (gastrointestinal and renal toxicities, and impaired clotting), COX-2 inhibitors (cardiovascular risks and renal toxicity), or opioids (respiratory depression, nausea/vomiting, sedation, disorientation, physical dependence, and the risk of addiction).

About Osteoarthritis of the Knee

Osteoarthritis of the knee is a common, progressive disease in which the joint cartilage breaks down. This breakdown causes the bones to rub against each other resulting in stiffness, pain, and loss of movement in the joint. In advanced stages, the pain becomes intractable and disabling, limiting patients’ mobility and activities. At least five million patients in the U.S. are suffering from moderate to severe osteoarthritis of the knee and are candidates for knee replacement or aggressive non-surgical interventions to address the debilitating effects of end-stage osteoarthritis of the knee.

About Anesiva and its Diverse Pipeline of Pain Products

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has two drug candidates in development for multiple pain-related indications. A New Drug Application (NDA) has been filed for the most advanced product, Zingo(TM). The second product in the pipeline, Adlea (formerly 4975), has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, moderate-to-severe pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva’s leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: the timing and outcome of our clinical trials and the results of the regulatory approval process for our product candidates. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva’s Form 10-K for the year ended December 31, 2006.

Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement

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Device gives Formula Atlantic driver hope after leg amputation, chronic pain brought him down

June 25, 2007

Then again, it’s a long way to the June Sprints from daily doses of morphine and thoughts of suicide.

Meet Michael Roman.

He’s a tattooed and bleached-blond 41-year-old who hops from place to place on his left leg - his only leg - when he’s not seated in his wheelchair or his race car.

He is at the same time proud and repentant, humbled and thankful, inspired and inspiring. He positively glows.

Roman races for himself, yes, but mostly for the people who reside where he has lived, trapped in the cracks of medical science, hopeless, helpless, addicted and bitter.

“I tell the kids all the time, if you dream big, big things happen,” Roman said. “It takes courage to dream but, also, if they come true there’s no better feeling.

“As long as you’re moving toward a goal, you’re successful.”

Roman’s goal is threefold.

For his family, he’d like to make up for 10 years of being a miserable husband, father, son and brother and to pay them back for their inspiration and support.

For himself, he’d like to climb from Formula Atlantic-class club racing to the Indy Pro Series to the Indy 500 by 2009. He has more hope - about racing and about life - than he has had in a dozen years.

And for others like him who have ridden the downward spiral from injury to chronic pain to depression, he’d like to use racing to raise awareness of possible solutions and of sources for help, and he’d like to offer hope.

“If I can get 34 people - two at 17 races - to be a little bit better off than they were when I got there,” Roman said, “deal done.”

The native of Buffalo Grove, Ill., blew out his knee playing basketball, and the resulting surgery left Roman with a staph infection.

Although familiar with the operating room from his job as a surgical assistant at a St. Louis hospital, he could not have imagined 40 visits as a patient. Doctors first amputated Roman’s diseased leg in July 1995, and then “revised” the amputation numerous times all the way to his hip.

Although Roman still felt pain, he was able to race go-karts, as he had as a kid, and to dabble in stock cars before a torn muscle in 2000 increased his dependence on painkillers.
Bottoming out

“It seemed like we had one failure after the other, and hope was a hard thing to come by,” Roman said. “When the doctor said, ‘Go home, medicate yourself and accept your life,’ that took the bottom out.

“I’m a million dollars in debt, I’ve had 40 operations over a decade and (second wife Suzy) has never known me to be healthy, to be consistent, non-medicated or sane.”

Suzy did her best to maintain her husband’s spirits and humor. She also held his morphine at night to keep Roman from doing “something stupid.”

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A couple hundred milligrams of the powerful drug dictated when Roman would wake up, and the pain would determine his mood.

“At first I told my mom, ‘I don’t ever want to see him again,’ ” said Roman’s 14-year-old son, Anthony, who spent Wednesdays and every other weekend at his father’s house.

“Sure, I called him ‘Dad’ but what did he do? He sat and yelled at me because of all of his medication. At the time I knew something was going on.”

On Roman’s umpteenth trip to seek a bump in his medication, his family doctor sent him to a pain management specialist, who suggested an implanted spinal-cord stimulation device.

Even with his medical background, Roman was frightened. He had averaged an operation every three months, and none of them had freed Roman and his family from their hell.

Finally Roman consented and went weeping into surgery in December of 2005. Two weeks later, Roman could cut back his medication, and now he is pain- and morphine-free.

“People get mad when I say ‘miracle,’ but if you’d seen this family 16 months ago, that’s what we were praying for,” Roman said.

“We’d kind of promised each other that if we ever found a solution for this that we’d do whatever we could as patients and a family to get the word out.”

With help from the device’s maker, Advanced Bionics, Roman started a Web site, www.raceagainstpain.com, as an online community for people who suffer from chronic pain and for their families.

It’s not about selling stimulators, Roman said, but about selling hope. Users can share stories, tell each other what relief efforts have or haven’t worked, commiserate and prop one another up. To bring awareness to the site, Roman’s car carries its address.

He speaks to groups of doctors and patients, alike. Upcoming is a trip to Walter Reed Hospital to address injured Iraq war veterans.

“Every doctor has a case that they’re not sure what to do with,” Roman said. “I’ve been begging them to take that one case, that train wreck like I was, and give him some hope.”

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Why the cold hurts - research has implications for pain relief

June 21, 2007

Freeing knotted shoelaces with fingers that are frozen stiff is extremely difficult and can even be painful.

The reason that sensitivity and dexterity are poor is that both nerves and muscles perform their tasks reluctantly when they are cold. Nevertheless ice-cold fingers ache and do so all the more in response to the lightest of knocks or squeezing. As unpleasant as this is, it serves as protection against frost lesion. The question of how pain can still be registered despite the otherwise hampered function during cooling has recently been explained by researchers at the Institute of Physiology and Pathophysiology at the University of Erlangen-Nuremberg. Together with scientists from the Anaesthesiology Department at the same University and a group from the University College London, they have demonstrated that the endings of nerves normally involved in signaling pain are equipped with a frost tolerant igniter of nerve impulses. The work has appeared on the 14th of June as a “letter” in the science journal ‘Nature’.

In order to function properly nerve fibres and their endings must generate a small, but explosively rapid, electrical sodium current known as a nerve impulse (action potential). The sluices for this, the sodium channels, open and close more slowly when cooled and also become more likely to be literally ‘frozen’ in a state known as ’slow inactivation’. Pain signaling nerves however possess a rather special sodium channel subtype, the NaV1.8, which also becomes more sluggish with cooling but can resist the entry into slow inactivation and thus the channel is in a position to still generate action potentials at 10?C skin temperature.

The NaV1.8 sodium channel is also renowned for being resistant to blockade by a toxin found in the tasty, albeit for Sushi too expensive, Pacific Fugu fish. The bacterially derived substance from the fish?s entrails known as Tetrodotoxin (TTX) blocks most other sodium channels and in doing so can be fatal to the gourmet even at very low doses. A second feature of NaV1.8 is that it is found exclusively in the nerve endings and cell bodies of pain signaling nerves, called ‘nociceptors’. Nociceptors normally use the TTX-sensitive sodium channels to signal pain. To rescue their function from cold block NaV1.8 channels are recruited so that pain from the extremities can still be registered. Normally, the excitability of these nerve fibres is rather independent of NaV1.8 because its threshold for activation is too high. During cooling however the electrical resistance of the neuronal cell membrane increases. This means that the isolation between the inside and the outside of the cell is better and as such less of the small sodium flow in the nerve ending is lost to a short circuit. In this way, the high threshold of NaV1.8 is reached and its rescue function can be realized.

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The restriction of NaV1.8 to nociceptors that register pain has made this sodium channel an attractive target for the pharmaceutical industry. The hope being that blockade of this channel could selectively block pain without side-effects. This made the disappointment all the more poignant when eight years ago Prof. John Wood?s group (UCL) succeeded in removing the NaV1.8 from the genetic code of mice only to discover that this deficit resulted in hardly any change in sensitivity to various forms of painful stimulation. It was only the response to painful cold that was not tested in these animals and this omission has now been filled in the current work. The experiments this time showed that in the wild such animals would be in danger, since they feel cold but are unable to register cold-induced pain.

Very recently, the American companies Abbott and Icagen reported a possible future medication directed against pain (Jarvis et al., 2007, PNAS) that preferentially blocks NaV1.8. This substance works particularly well in animal experiments against ‘cold allodynia’, a form of over-sensitivity to cold that can occur after damage to peripheral nerves. The research from the Erlangen group explains this action.

This research advance was made possible by the collaborative work of the research group of Professor Peter Reeh at the Institute of Physiology and Pathophysiology together with the anaesthesiologists Dr. Andreas Leffler and Professor Carla Nau, that began as part of the Special Research Program (DFG-SFB 353) “Pathobiology of the origin and processing of pain”. The research in the Anaesthesiology Department at the Erlangen University Clinic is now supported by the German Research Society (Focusgroup KFO130). For the Nature publication, the involvement of the team of Professor John Wood was crucial.

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Nobility Homes Q2 Profit Declines On Lower Revenues - Update [NOBH]

June 13, 2007

6/7/2007 9:36:06 AM Thursday, Nobility Homes Inc. (NOBH), a builder of homes, revealed its second quarter financial results reporting earnings that declined from last year on lower revenues.

The Ocala, Florida-based company reported second quarter net income, after taxes, of $1.07 million or $0.26 per share, compared to $1.92 million or $0.46 per share in the earlier year quarter.

Quarterly operating income was $1.14 million, in comparison with $2.51 million in the same quarter last year. Sales for the quarter were $10.3 million, down from $16.69 million in the previous year quarter.

Terry Trexler, President stated, “Second quarter sales and operations for fiscal 2007 were adversely impacted by the reduced manufactured housing shipments in Florida plus the overall decline in Florida and the nation’s housing market.”

The company noted that its second quarter financial position remains very strong with cash and cash equivalents, short and long-term investments of $23.0 million and no outstanding debt.

For six-month period, the company reported net income, after taxes, of $1.8 million or $0.44 per share, in comparison with $3.4 million or $0.82 per share in the corresponding period last year.

The company reported operating income for six-month period of $1.79 million, down from $4.47 million in the earlier year quarter. Sales for the period decreased to $19.13 million from $30.34 million in the year ago period.

In October, the Special Committee of the Board had retained Savvian Advisors, an investment banking firm, to assist in the exploration of strategic alternatives. Following receipt of a report from Savvian Advisors, the Special Committee has determined that Nobility Homes should remain an independent, public company for the immediate future.

The company did not purchase any shares of its common stock during the first six months of fiscal 2007 due to the exploration of strategic alternatives. Nobility plans to reactivate its stock repurchase program during the third quarter of fiscal 2007.

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NOBH closed Wednesday’s trading session at $20.90 million.

Merck Migraine Drug Under Development Gives Pain Relief - Update [MRK]

6/7/2007 9:29:05 AM Merck & Co. Inc. (MRK), a global research-driven pharmaceutical company, on Thursday said that its drug MK-0974, which is under development, in the Phase II trial gave pain relief to migraine suffers after two hours of medication and the pain relief continued for 24 hours.

MK-0974 is now in Phase III clinical development for the treatment of migraine in adults.

“Larger clinical trials, such as those now underway, will provide more insight into the efficacy and safety profile of MK-0974,” said Tony Ho, senior director of Clinical Neuroscience, Merck Research Laboratories.

The company stated that the treatment with MK-0974 was generally well tolerated with no reports of serious adverse events. The most common adverse experiences occurring in patients treated with MK-0974 were nausea, dizziness and somnolence.

The Whitehouse Station, New Jersey-based Merck stated that it still expects to file New Drug Application for MK-0974 with the U.S. Food and Drug Administration in 2009.

If the drug is approved, the company said, it may be the first in a new class of migraine treatment since the approval of the first triptan drug in 1991.

MRK lost $0.28 or 0.55% in the pre-market trading at $50.48 on a volume of 100 shares.

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Back Pain Relief Without Surgery

June 6, 2007

Is back pain slowing you down?

A non-surgical option could help you find relief.

90% of adults will have back pain at least once in their life and the last thing many people want to have is surgery.

Now there is an option that has many people finding relief without going under the knife.

Last year, Rick Terrana hurt his back and could not walk or sit in a chair without being in pain.

Rick’s back is better now, in fact, he recently ran his first half marathon.

This is the DRX 9,000.

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It is a machine that literally pulls the spine apart, relieving pressure on the disc.

The technology is so precise; doctors can pinpoint the exact problem area.

Luis Crespo, M.D., pain management specialist, said, “By changing the level and the angle of the pull, we can target the specific disc that’s affected instead of just pulling the entire spine.”

This treatment is for patients with any disc related problem.

Studies show nine out of ten patients significantly reduce their back pain after 20 treatments and there are no side effects.

The cost of treatment is about $35-hundred and not all insurance companies will cover the cost

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Chronic Pain or Drug Addiction?

June 5, 2007

It was Sunday morning on my weekend off and I was stalked by a narcotic seeker. She conned the hospital operator twice into paging me to get around my partner who was on-call. Then she made eight phone calls to my home throughout the day. Thanks to caller ID, I was able to avoid them.

Multiple calls to my house outside of office hours for pain meds is a red flag for a patient with a drug problem. So is using extraordinary measures to work around my on-call partner. I’ve seen both of these warning signs before.

Doctors are often accused of not adequately treating pain and being insensitive to patients’ needs. But they also have found themselves prosecuted or disciplined by licensing boards for prescribing too much pain medication. Trying to find a balance can be tricky.

The quandary has intensified in recent years, with an increase in abuse of narcotic painkillers. Because of the potential for patient addiction and the resulting liability risk, some physicians would like to avoid treating patients with pain medications all together.
DOCTOR’S OFFICE FORUM

[Forum]
When should doctors draw the line on prescription painkillers? Share your thoughts with Dr. Brewer in an online forum. Readers are urged to post here, rather than send email, as Dr. Brewer may not be able to respond to all mail.

I don’t want to go that far. There certainly are patients that have lifelong pain and have permanent pain medication needs. I write prescriptions for strong medications — narcotic medications that could become addictive — without worrying too much about it.

I have a lady with clogged arteries in her legs who is on 60 mg of Oxycontin daily and has been for years. Such patients may require a lot of medication to get relief, but their needs and their medication dosages seem to be stable. They often require gradual dosage increases, but most don’t really “want” the increase due to side effects.

On the other hand the addict patients want higher doses more often and they quickly go through anything I might give them. When I prescribe long-term narcotics for a patient I think to myself, “could I defend this to doctors on the licensing board? Are this patient’s needs potentially worth the scrutiny I might get?” I admit that the headlines of doctors being prosecuted for prescribing pain medications have made me gun shy.

Some patients are outright fakers looking for a fix. I found out that the nice married guy with three kids I’d been treating with the common anti-anxiety medication Xanax was dealing cocaine out of his house. The cocaine was evidently causing his anxiety. He fooled me initially, but not for long, as the small-town family doctor has a broad network of sources.

Sometimes what patients really need is a drug-treatment program rather than a steady supplier for their Vicodin scripts. They doctor shop, and often come from a distance when every doctor in their own community and their local E.R. has wised up to their activities.

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We’re supposed to sort out the good (true chronic pain) from the bad (drug addiction without an underlying health malady), but often it’s not easy. The toughest are the patients with an appropriate diagnosis for chronic pain medication but who also have addictive tendencies.

Patients with prescription-drug addiction seek narcotics by feigning or magnifying common ailments like chronic daily headaches, a bad back or chronic abdominal pain. They complain of pain from disorders that often can’t be objectively verified, and they often ask for their drug of choice by name. They claim to be allergic to essentially any pain medication that can’t give them a mind-altering buzz. Drug seekers tend to tell lies about their past evaluations and activities.

Having the old records is the key to the real story. A review of one patient’s records showed she had requested a refill of her medication after “her cat knocked it over in the sink.” She had told the same story to three different doctors over the span of five years.

Such patients take medication more frequently than they should, then call with a really good story and emotional plea for an early refill. Running a little short one time is believable, but for drug addicts this is a chronic problem that escalates.

Patients who call the office after a few days claiming intolerance to a drug I just prescribed are often looking to get an extra script of a similar drug. It worked the first time, but now I’m wise to the ploy.

Clinics have sprung up to help patients with chronic pain, and sometimes they do help. But I’ve also seen from several clinics a preference for doing profitable procedures on people followed by physical therapy until the insurance benefit runs out. Then the patients are dumped right back in my lap with the same issues and medication challenges they started with.

Taking care of patients with tough pain problems and sometimes hidden agendas is negotiating a liability mine field. Two patients that I turned down for pain medications later overdosed on another doctor’s prescription. One of them complained bitterly to her HMO that I wouldn’t meet her demands for the type of pain medications she eventually overdosed on.

My weekend caller will be getting some help with her drug problems or she will be getting another doctor.

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IDD Therapy Offers Non-Surgical Back Pain Relief

May 31, 2007

Suffering from acute or chronic lower back pain? There is an innovative treatment option at the Advanced Physical Medicine Center locally in Fairview, N.J, which will get you back on your feet.

“There are only a handful of these machines in Bergen County,” explains Dr. Michael Arber, a chiropractor at the center, who administers non-invasive Intervertebral Disc Decompression (IDD) therapy. “The best part about the equipment is that it’s not just temporary relief. It actually reduces the size of disc injuries and helps the surrounding soft tissue return to normal function.”

Thanks to IDD Therapy, a non-surgical treatment, approximately 85 percent of people can relieve back pain symptoms without drugs or surgery. This revolutionary technology is ideal for herniated or bulging discs, degenerative disc disease, spinal stenosis, sciatica and acute or chronic back pain.

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IDD therapy is deployed via the Accu-SPINA System, and works to reshape the spine using computer technology to apply traction to spots causing lower back pain. The traction provides a negative pressure that allows fluid, blood and nutrients into the affected discs that cause pain. In other words, as each challenge is introduced to the body, it supports muscles and ligament tissue to retone itself, re-educating the neuromuscular system and relieving pain. The typical treatment is 18 to 24 treatments over eight weeks, and each session lasts 30 minutes.

“It’s not painful. Once on the machine, a lower harness pulls at a specific angle and tension to alleviate the area of stress,” says Dr. Arber. “While IDD therapy is not currently reimbursable by insurance carriers, the cost of getting lower-back surgery is far greater. And IDD therapy is non- invasive.”

Dr. Arber says a lumbar MRI and an exam is all that is needed to determine if IDD therapy is right for a patient.

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Surgery beats drugs and therapy for treating common back ailment

May 31, 2007

Surgery is twice as effective as physical therapy and drugs for relieving pain and improving mobility in one of the most common back problems, researchers reported today.

The study, published in the New England Journal of Medicine, gives “us more confidence in recommending surgery to our patients,” said Dr. Mark J. Spoonamore of USC’s Keck School of Medicine. The recommendation is “not just our gut feeling but based on a strong scientific foundation.”

Dr. Arya Shamie of UCLA’s David Geffen School of Medicine added, “This is a great study … confirming what doctors have believed all along.”

The condition, called degenerative spondylolisthesis with spinal stenosis, occurs when one lumbar vertebra in the back slips forward relative to the one next to it, pinching the spinal cord and producing severe pain in the legs.

The condition affects as many as 600,000 Americans, although only about half of those seek medical treatment and perhaps only a quarter of them undergo surgery, according to Dr. James W. Weinstein of the Dartmouth-Hitchcock Medical Center in Hanover, N.H., who led the study.

The bulk of the patients are older than 50, and women are six times as likely as men to suffer from it, with African American women at greatest risk.

Conventional treatment involves physical therapy, steroids to reduce swelling and anti-inflammatory drugs. But only about 20% of patients get better and 20% stay the same without surgery, according to Shamie, who was not involved in the study.

Surgery relieves pain by removal of bone and soft tissue in a procedure called a decompressive laminectomy.

Because of the aging American population, back surgeries are one of the fastest-growing areas of medical care, with hospital costs totaling more than $21 billion per year, according to Dr. Richard A. Deyo of the University of Washington.

The federally funded study enrolled 607 patients at 13 medical centers in 11 states. Of those, 372 underwent surgery and 235 did not.

Two years after their enrollment in the study, the patients who did not undergo surgery reported only modest improvements in their condition.

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Those who had surgery reported significantly reduced pain and improved functionality. Major improvements were seen within six weeks after the surgery. The most common complication of the surgery was a tear in the lining of the spinal cord.

“Up until now, we suspected surgery produced better results, but we had little objective data to support that,” Weinstein said.

“With the results of this study, we can now discuss much more fully the surgical and nonsurgical options available to our patients so that they can make an informed choice.”

In a second study in the journal, a Dutch team led by Dr. Wilco C. Peul of the Leiden University Medical Center studied 283 patients with severe sciatica, which produces a burning pain in the sciatic nerve that runs down the outside of the leg. The pain is caused by herniated disks in the spine that put pressure on the sciatic nerve.

Peul and his colleagues reported that sciatica patients undergoing surgery got much faster relief from the pain than those receiving only physical therapy and drugs, but that at the end of a year, 95% of patients in both groups were largely free of pain.

Those results were similar to findings reported by Weinstein and his colleagues last year in a much larger study — although Weinstein found a small but persistent benefit from surgery.

In a third track of the U.S. study, Weinstein and colleagues will report later this year on the benefits of surgery for patients with spinal stenosis — a narrowing of the spinal column — caused by degenerative arthritis.

The team is also following all of the patients in the three tracks for 10 years to see how well the treatments hold up with time.

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Gentle dental: New techniques and technologies are helping patients who quake at the words, ‘Open wide’

May 29, 2007

Once a military dentist, Dr. A. W. Mercier Jr. says he can’t forget the burly fighting men who “could kill me if I sneezed,” but were nevertheless terrified of him.

“They looked up with fear in their eyes and said, ‘Don’t hurt me, Doc.’ ”

Today, to gain the trust of those who are too riddled with anxiety even to come to the office, Dr. Mercier has met new patients at coffee shops. “Once you gain their trust, you can help them.”

Dr. Mercier, who has his practice in South Dartmouth, uses air abrasion and hand-tool techniques to remove cavities. The combination, he says, is usually painless since the vibrations and heat of the traditional drill are eliminated. Often, no local anesthetic is needed. This is just one of many options for people who avoid dentists out of fear.

If the words “open wide” make you break out into a sweat, you are not alone.

The Massachusetts Dental Society reports that seven out of 10 people get clammy palms before going to the dentist, and between 30 and 40 million Americans are so afraid that they live with oral infections and pain rather than get the care they need.

For dentophobics, the descriptors “gentle dental” and “pain free” promise relief. They are catch phrases for new techniques and technologies that promise to take the anxiety out of sitting in the dentist’s chair, and they are showing up in a lot of advertising.

“The mouth is a very personal place. To have pain in there is a serious violation,” says Dr. Michael Jusseaume, who has a practice in Westport and is the Southeastern District Trustee for the Massachusetts Dental Society.

One way to make a dental visit less threatening is, obviously, to eliminate discomfort. Dr. Joel Weaver, director of anesthesiology for Ohio State University College of Dentistry, says that new drug compounds and slick methods of giving injections are making local anesthesia more effective than ever.

If blocking pain is the key to making people less anxious in the dental chair, then why are many still afraid?

Fear of the needle is a common problem. But, needles are so fine that along with topical numbing gels you’re not supposed to feel the puncture anymore. Doctors say that what stings is the pressure of the anesthetic entering gum tissues.

For that there is “The Wand,” a computer controlled syringe that delivers anesthetic in tiny doses. It’s touted as one of the new pain-free technologies. However, the injection takes longer, and most people want a needle out of their mouths quickly, Dr. Weaver says.

For those who sit rigid with anticipation that they might feel pain, the fast-acting inhaled sedative nitrous oxide (also called “laughing gas” for its ability to relax people to the point of giggling) has been used for decades as a calming agent. It is easy to regulate; with only a few deep breaths of air, patients clear their heads.

Dr. Michael Katz of Westport describes the effects of nitrous oxide as “almost like having a couple of drinks. There is no danger of loss of consciousness. It raises the pain threshold and makes time go by quickly.”

Virtual vision headsets are a drug-free alternative that Dr. Katz offers to reduce anxiety and make long appointments more comfortable. Watching a movie through the headsets gives patients an unobstructed view while the dentist works in their mouths. “It takes their minds off what we’re doing. It helps. I don’t know why more people don’t have them,” Dr. Katz says.

Of his gentle approach, he says, “I’m not doing anything that shouldn’t be done on a routine basis (by all dentists).”

Never mind being treated by a dentist, even the idea of being in a dental office, with its odors and sounds, is too much for some people. Anxiolysis (a fancy word for taking a mild sedative like Valium ahead of time) could be an answer and dentists are qualified to prescribe the medications.

Lisa Majewski of Swansea avoided the dentist for 10 years after a bad experience with a root canal. For her, Dr. Katz prescribed a mild sedative. “I’ve had two kids, but when it comes to my mouth I’m a big baby,” she says. “My biggest fear was getting hurt again and having someone make me feel bad for not going (to the dentist) for a while.”

Thanks to his gentle manner, medication and watching a movie on the headsets, Mrs. Majewski has been able to let Dr. Katz complete gum surgery, a root canal and two crowns.

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Sedation dentistry is a relatively new phenomenon that some people turn to who have developed major dental problems but cannot face the necessary work while remaining awake. Short of general anesthesia, there is an option called “conscious sedation” that allows the patient to be in what’s commonly called a “twilight state” without the need for hospitalization. Dr. Jusseaume says that conscious sedation is a “whole lot safer. The least amount of drugs is always the best. Every time someone is put to sleep they might not wake up.”

However, some patients determined to be completely knocked out go to the West Coast where general sedation dentistry is more common. One such practitioner is Dr. David Blende of San Francisco, who features “sedation dentistry for the fearful, phobic and special needs patient.”

Over the past 20 years, Dr. Blende has treated patients with severe dental phobias from 26 states and 16 countries, according to practice manager Amanda White. Often, their patients want to have decades of neglect cared for all at once. She says that the Blende Group is the “national leader in definitive full-mouth rehabilitation.”

While anesthetized in a hospital operating room, specialists can perform crowns, root canals, gum surgery, extractions and fillings that would normally require many dental visits. “A lot of patients, once they get through this massive process, are able to go in to a dentist for regular maintenance,” Ms. White says.

While medical insurance may cover the cost of the hospitalization, patients still need to cover the fees for all of the dental work. The bill for this specialized care can add up to the cost of a mid-sized car.

One of Dr. Blende’s patients flew across country from the Boston-area and forked over $25,000 to be sedated for a full mouth cleaning, five extractions, four crowns, four veneers and eight fillings.

Brian (who asked that his last name not be disclosed) says that he neglected his dental needs for 20 years following bad experiences as a youngster treated by novices at a dental school clinic. For Brian, even simple cleanings were out of the question.

“The whole idea of metal scraping my teeth terrified me. Sitting in the chair and having someone prodding around in my mouth was something I couldn’t do.”

In general, dentists seem to prefer not to use sedation partially because, in the long run, it does not help patients get over their fears. Dr. Jusseaume says that none of the modern gadgets or medications can substitute for a good old-fashioned relationship of trust between dentist and patient.

Mattapoisett resident Karen Cosgriff chose her dentist, Dr. Joseph Mills of Dartmouth, specifically because a friend recommended him as trustworthy. After years of avoiding dentists because of past problems with pain and gagging, she says, “I really like this guy. He’s quick. He doesn’t spend a lot of time with his fingers in my mouth making conversation. By the time I start to become my paranoid neurotic self, it’s over.”

Those who have trouble trusting dentists tend to be people 50 years of age or older who had painful experiences with techniques that are less refined than they are now, Dr. Jusseaume explains.

For the younger generation, he says, going to the dentist is not particularly scary. “Kids today are growing up with dentistry that is performed kindly and gently.”

The American Dental Society does not recognize a specific specialty in gentle dentistry. However, Dr. Michael Krochak of the Dental Phobia Treatment Center of New York says that “a lot of dentists do it intuitively.”

To find a gentle dentist the patient needs to “feel empowered to search. If you don’t get a warm-fuzzy on the first visit, move on.”

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