Low Demand Because Of Swine Flu Scare Forces Three Large US Airlines To Cut Mexico Flights

To add to the list of European airlines that have stopped flying people to Mexico, US Airways, Continental Airlines and United Airlines announced they are temporarily stopping some flights to Mexico. The airlines say this is due to a significant drop in demand.

38% of U.S. Airways flights to Mexican destinations will be dropped between May 10 and July 1.
60% of United Airlines flights to Mexico will be cut. This means only 24 flights a week will continue. United says this will increase to 52 flights per week in June.
40% of Continental flights will be cut. The airline says that capacity will also drop (maximum possible number of passengers in each flight). Continental flies more people in and out of Mexico than any other airline in the world. Continental usually has approximately 450 flights per week to Mexico.

The three US airlines have joined several others, including Air Canada, First Choice (UK), Monarch (UK), Thompson (UK), Thomas Cook (UK), Air Europa (Spain) in cutting flights to Mexico.

All airlines stress that this is a temporary measure, and after closely watching the situation, flights will resume to normal as soon as possible.

Several airlines that continue having flights into Mexico are adding a doctor to each plane. The aim is to better detect potential cases of swine flu.

Experts have indicated today that the current swine flu virus is a mild one. However, if it spreads and more people catch it there is a greater chance of a mutation. A mutation can occur if the swine flu virus (more appropriately known as the North American Flu virus) infects a person who is already infected with a normal seasonal human flu virus. It would then have the opportunity to exchange genetic material with that virus, creating a new virus – a mutated one.

See our Map Of H1N1 Outbreaks
See our Mexico Swine Flu Blog

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Integrating Palliative Care For Dementia Into Primary Care

Greg A. Sachs, M.D., has received an award from the National Palliative Care Research Center to conduct a study aimed at improving quality of life and decreasing suffering for older adults and their family caregivers. The award is one of only two pilot project support grants funded by NPCRC in 2008.

Dr. Sachs will evaluate the feasibility of incorporating an outpatient palliative care program for patients with dementia into the primary care setting. Dr. Sachs’s multidisciplinary team will build on a successful model that he previously developed for a geriatrics specialty clinic. That model, the Palliative Excellence in Alzheimer Care Efforts (PEACE) Program, provided improved symptom management, enhanced family support, and assistance with difficult decision making.

The Indiana version (IN-PEACE) will try to extend this approach into primary care practices where most older adults receive their health care.

“I’m most excited about working with other Indiana University clinicians and researchers who have used this collaborative care approach with primary care to improve the care of older adults with depression, dementia or frailty,” said Dr. Sachs. “This will allow us to reach out into the community to help more patients and their families and to do so before they’ve experienced needless suffering.”

This two-year pilot project has the potential to significantly improve care for community-based individuals with dementia, and to shape future program development and policy for older adults living at home, in assisted living environments, or in nursing homes.

A noted researcher in the fields of geriatrics and medical ethics, Dr. Sachs is an IU professor of medicine and the chief of the Division of General Internal Medicine and Geriatrics; a Regenstrief Institute, Inc. research scientist, and an IU Center for Aging Research center scientist.

“People with dementia are an especially challenging group of patients for most primary care practices,” says Dr. Sachs. “Providing excellent care as the illness progresses really takes a team approach and coordination with community-based services and resources ranging all the way from homemakers to hospice. Most physicians do not have the training, time or staff to provide palliative care to this population.”

Palliative care focuses on relieving suffering and supporting the best possible quality of life for individuals living with serious illness. Doctors, nurses, social workers and other specialists care for patients with chronic illnesses, functional impairment, and a high burden of family caregiving responsibilities. Palliative care is provided at the same time as all other appropriate medical treatments.

NPCRC promotes evidence-based palliative care research in order to improve the care of patients with serious illness, and their families.

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USA Today Examines Challenges Of Comparing Health Services Prices To Find Best Deal

USA Today on Tuesday examined how many government and industry officials are “urging Americans to become better ‘shoppers’ for health care” in an effort to increase competition in the health care marketplace and reduce the cost of care. However, U.S. consumers face challenges in obtaining reliable quality and pricing data with which to compare health care services, according to USA Today. While quality information is available for some hospitals and procedures, it is rarely available for individual doctors, USA Today reports. Pricing data generally are of little use to U.S. consumers because they reflect average charges instead of actual negotiated rates. Critics of the effort to make U.S. residents better health care consumers say the industry “might never be a true marketplace,” in part because the most expensive health care decisions generally are made by sick, scared patients in emergency situations, USA Today reports (Appleby, USA Today, 5/9). USA Today on Tuesday also examined some insurers’ efforts to provide quality information. The article includes profiles of UnitedHealthcare, Humana, Aetna and HealthMarkets (USA Today, 5/9).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading

Tumor Growth Inhibition And Pharmacokinetic Profile Of NKTR-102 (PEG-Irinotecan) In Multiple Solid Tumors To Be Presented At Upcoming Conference

Nektar
Therapeutics (Nasdaq: NKTR) announced that preclinical data for its
proprietary product candidate NKTR-102 (PEG-irinotecan) will be presented
at the upcoming AACR-NCI-EORTC International Conference on Molecular
Targets and Therapeutics in San Francisco, California on October 25, 2007.
The presentations will highlight new results from preclinical trials of
NKTR-102 in mouse models of colorectal, lung and breast cancers. NKTR-102
is a PEGylated form of irinotecan created using Nektar’s innovative small
molecule PEGylation technology platform and is in Phase 1 clinical
development for the treatment of solid tumors.

In preclinical studies presented at ECCO 14 in September, NKTR-102
substantially suppressed tumor growth in an irinotecan-resistant mouse
colorectal tumor model, while irinotecan-treated groups did not show a
statistically significant decrease in tumor growth compared to controls.
Further, administration of NKTR-102 resulted in a significantly improved
pharmacokinetic profile for the active metabolite of irinotecan as compared
to treatment with irinotecan.

“The studies for NKTR-102 continue to indicate that Nektar’s small
molecule PEGylation technology can be a powerful platform for improving
chemotherapeutic agents,” Tim Riley, Ph.D., Vice President of PEGylation
Research at Nektar. “The new preclinical data in colorectal, lung and
breast tumor models also highlights the promise of NKTR-102 to serve as a
potentially new and powerful therapy in multiple solid tumor settings.”

Two poster presentations are scheduled:

October 25, 2007 – 12:30 PM – 2:00 PM (PT); 5:30 – 7:30 PM (PT)

Poster Session C — AACR-NCI-EORTC International Conference on Molecular
Targets and Therapeutics at Moscone Center West in San Francisco,
California.

— #C10 — A poster presentation of preclinical data focused on tumor
growth inhibition of NKTR-102 in mouse xenograft models of colorectal,
lung and breast cancer;

— #C157 — A poster presentation of preclinical data focused on the
pharmacokinetics and pharmacodynamics of the active metabolite of
irinotecan following administration of NKTR-102 in mouse xenograft models
of lung and colorectal cancer.

The AACR-NCI-EORTC International Conference on Molecular Targets and
Therapeutics Conference is an annual meeting of the American Association of
Cancer Research (AACR), the National Cancer Institute (NCI) and the
European Organization for Research and Treatment of Cancer (EORTC).

About NKTR-102

Nektar is developing NKTR-102, a PEGylated form of irinotecan, which
was invented by Nektar using its world-leading small molecule PEGylation
technology platform. The product is currently in Phase 1 clinical
development. Irinotecan is an important chemotherapeutic agent used for the
treatment of solid tumors, including colorectal and lung cancers. By
applying Nektar’s small molecule PEGylation technology to irinotecan,
NKTR-102 may prove to be a more powerful and tolerable anti-tumor agent.

Nektar PEGylation Platform

Nektar PEGylation technology can enhance the properties of therapeutic
agents by increasing drug circulation time in the bloodstream, decreasing
immunogenicity and dosing frequency, increasing bioavailability and
improving drug solubility and stability. It can also be used to modify
pharmaceutical agents to preferentially target certain systems within the
body. It is a technique in which non-toxic polyethylene glycol (PEG)
polymers are attached to therapeutic agents, and it is applicable to most
major drug classes, including proteins, peptides, antibody fragments, small
molecules, and other drugs.

Nektar PEGylation technology is also used in eight additional approved
partnered products in the U.S. or Europe today, including Roche’s
PEGASYS(R) for hepatitis C and Amgen’s Neulasta(R) for neutropenia.

About Nektar

Nektar Therapeutics is a biopharmaceutical company that develops and
enables differentiated therapeutics with its industry-leading PEGylation
and pulmonary drug development technology platforms. Nektar PEGylation and
pulmonary technology, expertise, manufacturing capabilities have enabled
nine approved products for partners, which include the world’s leading
pharmaceutical and biotechnology companies. Nektar also develops its own
products by applying its PEGylation and pulmonary technology platforms to
existing medicines with the objective to enhance performance, such as
improving efficacy, safety and compliance.

This press release contains forward-looking statements regarding the
potential of the company’s PEGylation technology platform and NKTR-102.
These forward-looking statements involve important risks and uncertainties,
including but not limited to: (i) preclinical testing and clinical trials
for NKTR-102 are long, expensive and uncertain processes, (ii) because the
NKTR- 102 product development programs are in the early phases of clinical
development, the risk of failure is high and can occur at any stage of
development, (iii) the company may fail to obtain regulatory approval of
NKTR- 102, (iv) potential competition from approved drugs or drugs under
development that may be safe and effective for the same indication as that
targeted by NKTR-102, and (v) the company’s patent applications for
NKTR-102 may fail to issue; patents that have issued may not be
enforceable; or unanticipated intellectual property licenses from third
parties may be required in the future. Other important risks and
uncertainties are detailed in the company’s reports and other filings with
the SEC including its most recent Annual Report on Form 10-K and Quarterly
Report on Form 10-Q. Actual results could differ materially from the
forward-looking statements contained in this press release. The company
undertakes no obligation to update forward-looking statements, whether as a
result of new information, future events, or otherwise. No information
regarding or presented at the scientific meetings referred to above (or
contained at the Internet links provided) is intended to be incorporated by
reference in this press release.

Nektar Therapeutics
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Kaiser Daily Health Policy Report Highlights Health News In Five States

Newspapers recently reported on health care-related issues for 2007 in Connecticut, Georgia, Louisiana, Maryland and New York. Summaries appear below.
Connecticut: Gov. Jodi Rell (R) on Dec. 27, 2006, unveiled a proposal that would create a health insurance plan with monthly premiums of no more than $250 to expand coverage to the state’s estimated 400,000 uninsured residents, the Hartford Courant reports. Under the proposal, the state would work “with representatives of major managed care providers” to develop a basic health insurance plan for uninsured residents between ages 19 and 64 that includes full prescription drug benefits, laboratory services and pre and postnatal care, Rell said. Copayments for prescription drugs would be between $10 and $15, and diagnostic services would be available for 20% coinsurance. Other services would have copays less than the cost of regular office visits, according to Rell. Residents enrolled in the plan would be required to pay part of their emergency department costs if the visit was later determined to be unnecessary. The plan would have a maximum lifetime benefit of $1 million but no annual maximum. In addition, Rell proposed a two-month premium waiver for uninsured infants and a mandate that would require all parents of school-aged children to declare annually that their children have health insurance (Cohen, Hartford Courant, 12/28/06). Rell said the state would not contribute to the cost of the program but would provide marketing and advertising funding (Medina, New York Times, 12/28/06). State House Speaker James Amann (D) said he is developing a plan that would spend $20 million to provide health coverage to all uninsured children in the state and provide a low-cost health plan to uninsured residents that would have monthly premiums of between $3 and $500 based on income (Hartford Courant, 12/28/06).

Georgia: State lawmakers next week are expected to discuss how to “come up with tens of millions of dollars to sustain the state’s current trauma care system” and encourage hospitals to participate in a network of trauma centers, as well as whether the state should change a rule that regulates where new hospitals are built, Morris News/Augusta Chronicle reports. A “certificate of need” enables the state to regulate the construction of new facilities in certain areas as a way to ensure that existing hospitals can survive by reducing competition. A state commission responsible for making changes to the program has recommended quicker certification, and most commission members support reducing the number of services subject to certification. Hospitals are expected to oppose any changes that “would allow private clinics to capture the most profitable medical procedures” and leave hospitals to provide less profitable services and care to those who cannot afford it (Eckenrode/Larrabee, Morris News/Augusta Chronicle, 1/2).

Louisiana: State officials are discussing which recommendations by the Louisiana Health Care Redesign Collaborative can be implemented without a federal waiver, but more extensive policy goals outlined by the collaborative likely will not be enacted “anytime soon,” the New Orleans Times-Picayune reports (Moller, New Orleans Times-Picayune, 12/25/06). The collaborative in October 2006 proposed a five-year plan for the New Orleans area to create a universal health system; establish a “medical home” network of physicians, medical clinics and hospitals; and reduce the region’s reliance on the Charity Hospital System (Kaiser Daily Health Policy Report, 10/24/06). HHS Secretary Mike Leavitt had set a Jan. 1 deadline for the state and federal government to develop a plan to insure at least 80% of New Orleans’ uninsured population, but Louisiana Department of Health and Hospitals Secretary Fred Cerise said the state will not “have a waiver by the end of the year” to allow the changes to be made. Some changes outlined by the collaborative can be made without the waiver, such as expanding Medicaid coverage to all children and expanding income eligibility for disabled adults. The state also can encourage the use of electronic health records and establish new quality standards for health care providers who receive government funding. Cerise said state and federal officials are working to reach an agreement on a “common set of assumptions” of the cost of expanding health care coverage to the uninsured. State Senate Health and Welfare Committee Chair Joe McPherson (D) said he is developing his own plan to expand health coverage that includes setting quality standards and expanding the use of EHRs but that does not include the insurance subsidies supported by Leavitt (New Orleans Times-Picayune, 12/25/06).

Maryland: Several Maryland organizations, lawmakers and a government panel are drafting proposals to expand health insurance in the state this year, the Baltimore Sun reports. While the proposals differ in specifics, major portions — including expanding Medicaid to cover more adults; helping small businesses finance health care coverage for employees through subsidies, tax breaks or by allowing businesses to form insurance pools to negotiate lower premiums; and requiring mandatory health insurance for all adults — are similar. The groups are hoping that a consensus can be reached on which plan or combination of plans is right for the state. According to the Sun, “[m]ost supporters” of insurance expansion favor a $1-per-pack cigarette tax increase to fund the proposals. “We’re thrilled a consensus has developed that coverage must be expanded,” Vincent DeMarco — president of Maryland Citizens Health Initiative, which is developing a health care proposal — said. DeMarco added, “Something’s going to happen in the next session” (Salganik, Baltimore Sun, 1/1).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading

Message From Tony Clement, Canadian Minister Of Health National Summer Safety Week – May 1-7, 2007

National Summer Safety Week

With winter behind us, Canadians are looking forward to the warm summer months ahead. While summer weather is a welcome change, it is important that Canadians take the time to remember how to reduce the incidence of preventable summer injuries and illnesses.

This year, National Summer Safety Week’s main theme is safe backyard trampolining. While trampolining is a fun outdoor sport, it is important that Canadians take precautionary measures while enjoying the activity.

For many, summer wouldn’t be complete without outdoor barbeques and picnics. By remembering some simple guidelines for preparing food, you and your family can safely enjoy all of the fresh foods summer has to offer.

This month, Canada’s New Government will launch SummerActive, a national community initiative that will help Canadians maintain and improve their health by offering healthy tips for safe summer fun. To learn more, please visit our website.

I encourage you to keep safety in mind as you have fun enjoying the best of Canada’s summertime.

Tony Clement
Minister of Health
Government of Canada

For more information on a variety of summer safety topics, please visit It’s Your Health – Summer Information. Continue reading

Medical News And Reporting Bias

From pharmaceutical company funding to the mentioning of brand name
medications, there are several potential sources of bias in medical
news media coverage. According to a report published in the October 1
issue of JAMA, news articles frequently fail to
report these sources of bias and other conflicts of interest.

Both physicians and laymen consider news articles an important source
of medical information. Michael Hochman, M.D. (Cambridge Health
Alliance and Harvard
Medical School, Cambridge, Mass.) and colleagues write that,
“An increasingly recognized
source of commercial bias in medical research is the funding of studies
by companies with a financial interest in the results.” Commercial bias
exists when news articles use brand medication names rather than
generic names and when news or research articles are funded by a
particular group, but we currently lack research on how frequently
these practices occur.

Hochman and colleagues analyzed pharmaceutical-funded
medication studies that appeared in five major medical journals – JAMA,
New England Journal of Medicine,
Lancet, Archives of Internal Medicine
and the Annals of Internal
Medicine – and their associated U.S. newspaper
articles and online new articles. The researchers assessed the
frequency and prominence of funding source indication, and they noted
how often articles used brand or generic names to refer to medications.
Additionally, the researchers surveyed editors at the 100 most widely
circulated U.S. newspapers in order to assess the practices of each
publication in divulging company funding and using generic medication
names.

Of the 306 news articles identified by the authors, 175 were from
newspaper sources and 131 from online sources. In 42% of the 306
articles about company-funded medication studies, the funding
source was not reported.
This practice of not reporting the funding source was not unique to
print or online media, as the authors found no significant difference
in nonreporting rates between
articles from the two media types. Two hundred seventy-seven of the 306
news articles dealt with medications that had both generic and brand
names. About 38% of these 277 used only brand names, and 67% used brand
names in at least half of the references to the medication.

When asked about reporting company funding in medical research
articles, 88% of newspaper editors indicated that his/her publication
often or always did. About 77% indicated that they often or always used
generic names to refer to medication in medical research articles. Only
3% of editors identified that their publication had a written policy
that mandated the reporting of company funding in articles about
medical research, and 2% of the editors noted a written policy that
required predominantly generic names to be used when referring to
medications.

The news article analysis and the survey of editors were not always in
sync for many publications. For example, the researchers analyzed 104
newspaper articles from publications whose editors indicated that
company funding was always reported. The researchers found that 45% of
these articles did not cite company funding. A similar result was found
in an analysis of 75 newspaper articles from publications whose editors
said that generic names were always used; 76% used brand names
in at least half of the
medication references.

“Our findings raise several concerns. For patients and physicians to
evaluate new research findings, it is important that they know how the
research was funded so they can assess whether commercial biases may
have affected the results. Additionally, the use of generic medication
names by the news media is preferable so that physicians and patients
learn to refer to medications by their generic names, a practice that
is likely to reduce medication errors and may decrease unnecessary
health care costs,” conclude Hochman and colleagues.

News Media Coverage of Medication Research: Reporting
Pharmaceutical Company Funding and Use of Generic Medication Names
Michael Hochman; Steven Hochman; David Bor; Danny McCormick
JAMA (2008). 300[13]:
pp. 1544-1550.
Click
Here To View Abstract

: Peter M Crosta

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Von Eschenbach To Resign As National Cancer Institute Director This Month, USA

Acting FDA Commissioner Andrew von Eschenbach on Wednesday announced that he will resign from his position as director of the National Cancer Institute, the AP/Chicago Tribune reports. His resignation from NCI takes effect June 10, according to HHS spokesperson Christina Pearson (AP/Chicago Tribune, 6/1). In March, President Bush nominated von Eschenbach to become permanent head of FDA, but Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) have placed a hold on the confirmation vote, which they say they will maintain until FDA makes a decision on whether to make Barr Laboratories’ emergency contraceptive Plan B available without a prescription (Kaiser Daily Health Policy Report, 4/7). John Niederhuber, a cancer surgeon from the University of Wisconsin, has been named to succeed von Eschenbach at NCI. Niederhuber has served as a deputy director of NCI since last fall (Grady, New York Times, 6/1).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading

Clinical Data On The Use Of Medtronic’s Deep Brain Stimulation System For Psychiatric Disorders To Be Presented At International Neurosurgical Meeting

Medtronic, Inc. (NYSE: MDT) announced that data on the use of its deep brain stimulation (DBS) system for severe, treatment resistant depression and obsessive compulsive disorder (OCD) will be presented by Ali Rezai, M.D., neurosurgeon at the Cleveland Clinic and investigator in the research, at the annual scientific meeting of the American Association of Neurological Surgeons (AANS). The data represent the largest and longest clinical experience to date with DBS for psychiatric disorders and was collected through the collaborative research efforts of several leading institutions. All of the studies being presented used the Medtronic DBS system to stimulate a target within the brain called the ventral anterior limb of the internal capsule/ventral striatum (VC/VS), which is a central node in the neural circuits that regulate mood and anxiety.

“The data we are presenting on 43 patients is the result of more than 10 years of work across multiple institutions worldwide. These data represent the largest number and the longest evaluation of patients with psychiatric disorders who have undergone DBS implants, including some with long-term follow up,” said Dr. Rezai, who represented an international working group of physicians studying DBS therapy for treatment resistant OCD and depression. “While OCD and depression treatment with DBS require additional clinical evaluation research, our early open-label experience to date is encouraging and indicates that DBS may help severely disabled and suffering patients who have exhausted other treatment options.”

Medtronic, in collaboration with leading physicians from around the world, has pioneered the use of DBS for movement disorders, including Parkinson’s disease, essential tremor and dystonia. Medtronic has been pursuing research of DBS for psychiatric disorders with physicians from many leading institutions, including those that were part of the research being presented this week that was supported by Medtronic: Cleveland Clinic; Brown University in Providence, R.I.; the University of Florida in Gainesville; the Catholic University of Leuven in Belgium; and Massachusetts General Hospital in Boston. This research into DBS for psychiatric disorders started more than a decade ago with the first DBS implant for the treatment of OCD in 1998 at the Catholic University in Leuven, Belgium. The first DBS implant for treatment resistant depression was performed at Butler Hospital in Providence, R.I., in 2003.

DBS for Obsessive Compulsive Disorder (OCD)

Data on DBS for OCD will be presented by Dr. Rezai today, Monday, April 28, at 2:45 p.m. central time. These data are from 26 patients with a history of severe, disabling treatment resistant OCD of at least five years who received a Medtronic DBS system. Follow-up data on these patients range from three months to three years.

DBS for Severe Treatment Resistant Depression

Data on the use of DBS for treatment resistant depression will be presented by Dr. Rezai on Tuesday, April 29 at 10:30 a.m. central time. These data include results from 17 patients with severe, treatment resistant depression who had failed multiple medical and electroconvulsive therapy trials and underwent an implant of a Medtronic DBS system. Following a survey of acute effects from various stimulation settings, each patient received individualized programmed stimulation. All 17 patients have reached six months of follow-up post-implant. Sixteen of the patients have been followed for a minimum of one year, with a mean of 22.8 months of follow-up.

“We are pleased to have reached this milestone in Medtronic’s 10-year history of investigating DBS therapy for psychiatric disorders,” said Richard E. Kuntz, M.D., corporate senior vice president and president of the Neuromodulation business at Medtronic. “These data represent the ongoing collaboration of psychiatrists, psychologists and neurosurgeons from several leading institutions and Medtronic and will help to further define the potential for DBS in treating a spectrum of neurological disorders.”

Medtronic’s Leadership in DBS

While DBS therapy is investigational for both depression and OCD, Medtronic plans to continue its work with leading neurosurgeons, psychiatrists and psychologists to initiate a trial of DBS for severe, treatment resistant depression in 2008. Medtronic is also pursuing a humanitarian device exemption (HDE) for DBS in OCD. Medtronic is the only company with a commercially available DBS system approved by the U.S. Food and Drug Administration (FDA) for Parkinson’s disease and essential tremor, as well as for dystonia under an HDE. To date, Medtronic’s DBS system has been implanted in more than 40,000 patients worldwide.

DBS is an adjustable, reversible, non-destructive and non-drug therapy using a surgically implanted medical device, similar to a pacemaker, to deliver carefully controlled electrical pulses to precisely targeted areas of the brain. Electrical stimulation is delivered to the brain regions that control functions such as movement or mood to seek improvements in clinical symptoms. The stimulation can be programmed and adjusted non-invasively (without surgery) by a trained clinician to maximize symptom control and minimize side effects.

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

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Mix Of Two Pain-Relief Procedures Can End Chronic Back And Leg Pain Without Drugs – Combination Of Two Implanted Nerve Stimulators

Help is on the way for patients who have undergone back surgery but who continue to suffer from chronic pain in their backs and legs, thanks to a novel technology pioneered by two Chicago-area pain management specialists.

Called a “hybrid technique,” the procedure combines an implanted electronic device called a dorsal column (spinal cord) stimulator with a newer technology known as peripheral nerve field stimulation (PNFS). This latest development in pain management gives patients drug-free relief from the severe, chronic back and leg pain of failed back surgery syndrome (FBSS), a condition suffered by nearly half of all spine surgery patients.

“Since 1968, physicians have used the dorsal column stimulator to control the leg pain common among patients with FBSS, but it does little to relieve back pain,” explains Eugene G. Lipov, MD, Director of Pain Research at the Northwest Community Hospital, Arlington Heights, Ill. “Recent studies have shown that peripheral nerve field stimulation is very effective in relieving back pain. This is what led us to combine these two technologies. Patients can have the best of both worlds: relief from leg and back pain they can’t get even with the strongest pain medications.”

Narcotics, such as codeine and morphine, don’t work well on nerve pain, which tends to be opiate-resistant. Implantable dorsal column stimulators stop pain signals from reaching the brain. Peripheral nerve field stimulation is a newer technology that is more focused on shutting off pain signals further away from the spinal column. Used together, the dorsal column stimulator and peripheral nerve field stimulation effectively block the body’s pain signals from the legs and back to the brain.

Performed as an outpatient procedure, the hybrid stimulator is implanted subcutaneously (under the skin) in the abdominal wall, side of the back, or in the upper hip area. It is approximately the size of a small cell phone. Typically, three electrical leads connected to the stimulator unit are then implanted in areas of the lower back and leg where the patient has felt the most pain. The patient is then able to control his or her pain by placing a small remote control device over the implanted stimulator. Patients feel their pain replaced by a mild tingling sensation. The hybrid stimulator can be left in place for seven to nine years, at which time a simple surgery is performed to replace the battery only, not the electrical leads.

“Using the hybrid technique we’ve literally seen patients’ quality of life dramatically improve right before our eyes,” says Jay R. Joshi, MD, Dr. Lipov’s research partner. “We have been able to offer hope and significant success to patients who have failed virtually every other treatment, including surgery, spinal injections, physical therapy, and medications. Many of our patients no longer need pain medications, and they quickly return to work and to the activities of daily living pain-free. It is a tremendous cost savings in terms of insurance claims, lost productivity at work, and offers patients an alternative to potentially addictive pharmacological treatment.”

In 2005, there were 34 million physician visits for back-related symptoms, according to the National Center for Health Statistics. A review article published in The Journal of the American Medical Association earlier this year estimated that $85.9 billion was spent in treating spine problems in 2005, with the greatest cost increase coming from use of prescription pain medications. “Clearly, this is an enormous problem for Americans, physically, emotionally, and economically,” Dr. Lipov says. “But we believe this new procedure will restore quality of life to millions of patients who suffer from back and leg pain and who have not found relief from surgery or drug treatment.”

Drs. Lipov and Joshi have implanted the hybrid stimulator in 19 patients since August 2007. Patients report 60% to 100% reduction in pain using the stimulator; to date, no patients have had the hybrid stimulator removed. Lipov’s and Joshi’s findings will be presented at the American Society for Stereotactic and Functional Neurosurgery conference in Vancouver, British Columbia, Canada, in June.

For more information, contact Patti Davis, DAVIS MEDPR, Inc., at 630.920.8042 (CT) or email pattidavismedpr.

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