Massachusetts cannot ban FDA-approved painkiller, judge rules

By Brady Dennis, Published: April 15 E-mail the writer

A federal judge on Tuesday blocked an effort by Massachusetts Gov. Deval L. Patrick to ban sales of a controversial new painkiller in the state, saying the governor’s move was preempted by federal law and could harm people who need the drug for pain relief.

In a five-page order, U.S. District Judge Rya W. Zobel sided with the drug’s California-based manufacturer, Zogenix, which had argued that Patrick had no right to bar a medication that the Food and Drug Administration has deemed safe and effective.

More: http://www.washingtonpost.com/national/health-science/massachusetts-cannot-ban-fda-approved-painkiller-judge-rules/2014/04/15/91436946-c4db-11e3-b574-f8748871856a_story.html

New pain killer Zohydro making headlines

Zohydro to be Manufactured by Same Company That Makes Addiction Medicine

By Join Together Staff | November 18, 2013 | 2 Comments | Filed in Addiction,Government, Healthcare & Prescription Drugs

The newly approved pure hydrocodone product, Zohydro ER (extended release), will be made by the same company that manufactures Vivitrol, a drug used to treat patients addicted to opioids or alcohol, The New York Times reports.

https://www.drugfree.org/join-together/addiction/zohydro-to-be-manufactured-by-same-company-that-makes-addiction-medicine

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Judge hits state on painkiller ban

Boston Globe ‎- 6 hours ago

A federal judge said Tuesday that she will probably strike 

down Governor Deval Patrick's emergency ban on the sale of Zohydro, 

http://www.bostonglobe.com/metro/2014/04/08/federal-judge-expresses-skepticism-about-mass-zohydro-ban/GLZp14pW8lAWmAniElJYhL/story.html

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Super-Strong 'Zohydro' About To Hit The Street - HuffPost Live

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FDA-Approved Painkiller Zohydro Concerns Critics - WebMD

www.webmd.com/pain.../new-painkiller-zohydro-criticized‎

WebMD

Feb 27, 2014 - A new narcotic painkiller is due to come on the market in March, and critics want the FDA to reverse its approval of the drug, Zohydro ER.

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From the manufacturer

1. Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules

   www.zogenix.com/content/products/zohydro.htm‎

   Zohydro™ ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate indicated for the management of pain severe enough to require ...

   ‎SUMAVEL DosePro - ‎Pipeline - ‎Investor Relations

Pain Scale

Chronic Pain Patient, first visit with Pain Management Doctor ~ SIGNING UNFAIR PAIN CONTRACT

Dammed if you do and dammed if you don't!
SIGNING A DRUG CONTRACT ~ FROM PATIENT PERSPECTIVE ~ GIVING UP YOUR RIGHTS

  Chronic pain patients are required to sign contracts with their pain management physician. Many of the stipulations in these contracts remove the patient's rights to privacy of their medical information as well as removing the constitutional rights that require law enforcement to obtain a warrant (meaning need to show probable cause to get such a warrant) in order to get the medical record. These contracts also often contain false information regarding what is drug seeking behavior, physical dependence, and tolerance to pain medication. Also they rely upon presumptive testing that is widely known to be inaccurate in order to deny treatment. Basically these contracts are set up in such a way that every chronic pain patient will eventually violate some part of the contract and lose treatment. Depression is NOT drug seeking behavior, it is a common occurrence with ANY chronic illness, not just chronic pain.

To learn more, including information about the so-called studies that the DEA rely upon to call prescription drug abuse an "epidemic" when the numbrs don't support it. To learn more about chronic pain, contracts, and more:
http://www.dailykos.com/story/2011/04...
http://pain-topics.org/ for updates on studies http://updates.pain-topics.org/

To learn more about Richard Paey, an example of the unfair investigation procedures and prosecution on chronic pain patients see here:
http://www.november.org/thewall/cases...

Dr Wiseman and PainShield IPPS Clinical Data Oct2013

Marijuana, Narcotics Help Patients Reduce Chronic Pain, Study Finds

WASHINGTON -- A new study out of UC San Francisco has found that medical marijuana, combined with certain opiates, appears to be a safe and effective treatment for patients with chronic pain.

The study, published this month in Clinical Pharmacology and Therapeutics, found that patients who use cannabinoids inhaled through a vaporizer, combined with long-acting morphine or long-acting oxycodone, experienced a greater reduction of pain than those who used opiates alone.

The 21 chronic pain patients involved in the study were split into two groups. Those who combined four consecutive days of exposure to vaporized cannabis with morphine experienced a 33 percent reduction in pain, while those who combined it with oxycodone saw a drop in pain of 20 percent. The study is the first to examine the combined effect of these drugs on humans.

"Pain is a big problem in America and chronic pain is a reason many people utilize the health care system," said lead author Donald Abrams, a professor of clinical medicine at UCSF and chief of the Hematology-Oncology Division at San Francisco General Hospital and Trauma Center. "And chronic pain is, unfortunately, one of the problems we're least capable of managing effectively."
Continue article here: http://www.huffingtonpost.com/2011/12/08/marijuana-narcotics-help-patients-reduce-pain_n_1137416.html

Deaths from painkiller overdose triple in decade

By STEPHANIE NANO - Associated Press

AP – 13 hrs ago..

NEW YORK (AP) — The number of overdose deaths from powerful painkillers more than tripled over a decade, the government reported Tuesday — a trend that a U.S. health official called an epidemic, but one that can be stopped.

Prescription painkillers such as OxyContin, Vicodin and methadone led to the deaths of almost 15,000 people in 2008, including actor Heath Ledger. That's more than three times the 4,000 deaths from narcotics in 1999.

Such painkillers "are meant to help people who have severe pain," said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention in Atlanta, which issued the report. "They are, however, highly addictive."

The report shows nearly 5 percent of Americans ages 12 and older said they've abused painkillers in the past year — using them without a prescription or just for the high. In 2008-09 surveys, Oklahomans reported the highest rate of abuse; the lowest was in Nebraska and Iowa.

The overdose deaths reflect the spike in the number of narcotic painkillers prescribed every year — enough to give every American a one-month supply, Frieden said.

Prescriptions rose as doctors aimed to better treat pain and as new painkillers hit the market.

Frieden and White House drug czar Gil Kerlikowske, who joined him at CDC headquarters in Atlanta, said states need to take sharp actions to reverse the long-running trend.

States oversee prescription practices and can rigorously monitor prescriptions and crack down on "pill mills" and "doctor shopping" by patients, Frieden said.
Click here to read the rest: http://news.yahoo.com/deaths-painkiller-overdose-triple-decade-160401910.html

Adhesiolysis in Repeat Caesarean Delivery Common, Costly

Adhesiolysis in Repeat Caesarean Delivery Common, Costly
Alice Goodman

May 20, 2011 (Washington, DC) — Adhesions from previous Caesarean deliveries severe enough to require adhesiolysis during repeat Caesarean delivery have clinical and economic implications, according to a retrospective review of a large database with discharge data from 60 hospitals in the United States. The data were reported here at the American Congress of Obstetricians and Gynecologists 59th Annual Clinical Meeting.

The matched cohort study found that for patients who required adhesiolysis, the cost per patient was $300 more, operative length was longer, hospital stay was longer, and postoperative complications were more frequent.

"Adhesions are a significant complication of surgery. C-sections are increasingly common in the United States, and anywhere from 30% to 50% of patients have adhesions," explained Michael Broder, MD, from the University of California at Los Angeles School of Medicine. He estimated that treating complications of adhesions related to Caesarean deliveries that are severe enough for adhesiolysis costs $25 million to $30 million per year.
Read The Rest

FDA Acts to Reduce Harm from Opioid Drugs

FDA Acts to Reduce Harm from Opioid Drugs


On This Page:

•FDA Opioid Strategy

•Widespread Problem

The White House on Tuesday unveiled a multi-agency plan aimed at reducing the “epidemic” of prescription drug abuse in the U.S.—including an FDA-backed education program that zeros-in on reducing the misuse and misprescribing of opioids.



Gil Kerlikowske, director of the White House Office of National Drug Control Policy, says the plan—a collaborative effort involving agencies of the departments of Justice, Health and Human Services, Veterans Affairs, Defense, and others—provides a national framework for reducing prescription drug abuse and the diversion of prescription drugs for recreational use.



“The toll our nation’s prescription drug abuse epidemic has taken in communities nationwide is devastating,” says Kerlikowske. “We share a responsibility to protect our communities from the damage done by prescription drug abuse.”



Key elements of the plan—called Epidemic: Responding to America’s Prescription Drug Abuse Crisis—include:



•expansion of state-based prescription drug monitoring programs

•recommending convenient and environmentally responsible ways to remove unused medications from homes

•supporting education for patients and health care providers

•reducing the number of “pill mills” and doctor-shopping through law enforcement

back to top



FDA Opioid Strategy

In concert with the White House plan, the Food and Drug Administration (FDA) is announcing a new risk reduction program—called a Risk Evaluation and Mitigation Strategy—for all extended-release and long-acting opioid medications.



Opioids are synthetic versions of opium that are used to treat moderate and severe pain.



FDA experts say extended-release and long-acting opioids—including OxyContin, Avinza, Dolophine, Duragesic, and eight other brand names—are extensively misprescribed, misused, and abused, leading to overdoses, addiction, and even deaths across the United States. FDA says a 2007 survey revealed that more than half of opioid abusers got the drug from a friend or relative.



Opioids—such as morphine and oxycodone—are used to treat moderate and severe pain. Over the past few decades, drug makers have developed extended-release opioid formulas to treat people in pain over a long period.



The new REMS plan focuses primarily on: educating doctors about proper pain management, patient selection, and other requirements and improving patient awareness about how to use these drugs safely. As part of the plan, FDA wants companies to give patients education materials, including a medication guide that uses consumer friendly language to explain safe use and disposal.



FDA wants drug makers to work together to develop a single system for implementing the REMS strategies. Toward that goal, FDA is now notifying opioid makers that they must propose a REMS plan within 120 days.



Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, says this risk management strategy is designed to improve pain management, while preserving patient access to these needed medications.



“This will be an important step toward addressing what has become a critical public health problem,” she says.



Doctor training, patient counseling, and other risk reduction measures developed by opioid makers as part of the REMS are expected to become effective by early 2012. They will be required for various brand name products known under the generic names:



•hydromorphone

•oxycodone

•morphine

•oxymorphone

•methadone

•transdermal fentanyl

•transdermal buprenorphine

back to top



Widespread Problem

FDA estimates that more than 33 million Americans age 12 and older misused extended-release and long-acting opioids during 2007—up from 29 million just five years earlier. And in 2006, nearly 50,000 emergency room visits were related to opioids.



"Opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients, but we know that they pose serious risks when used improperly—with serious negative consequences for individuals, families, and communities," says FDA Commissioner Margaret A. Hamburg, M.D. “The prescriber education component of this Opioid REMS balances the need for continued access to these medications with stronger measures to reduce their risks."



Although doctor training is not mandatory under the REMS plan, other federal agencies are working to get Congress to link mandatory physician training to the already required Drug Enforcement Administration registration number that doctors must have to prescribe controlled substances.



FDA will also require the risk management plan to include a way to determine if the education programs are helping to reduce problems associated with long-acting and extended-release opioids, as well as allowing patients who need opioids to get them.



FDA has had the power to request companies to develop REMS since 2007. The plans may also include medication guides and patient package inserts.



This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.



April 19, 2011
http://www.drugs.com/fda-consumer/fda-acts-to-reduce-harm-from-opioid-drugs-178.html

Drug Used For Neuropathic Pain Relieves Discomfort From Abdominal Adhesions: Henry Ford Study

Pregabalin, FDA-approved for neuropathic pain (pain caused by shingles and peripheral neuropathy), effectively reduced abdominal pain and improved sleep in women with adhesions, according to a Henry Ford study.


Adhesion pain, a common complication after abdominal or pelvic surgery, currently lacks effective therapy. Adhesions can also form after infections in the bowel such as diverticulitis.

"Many patients in the study went from debilitating pain to complete resolution of pain on pregabalin," says Ann Silverman, M.D., senior staff gastroenterologist at Henry Ford Hospital and lead author of the study.


Study results were presented at the American College of Gastroenterology's Annual Scientific Meeting in San Diego.


"Aside from the use of analgesics, additional surgery is the only treatment option for abdominal pain from adhesions but repeat surgery can lead to more adhesions," says Dr. Silverman.


The estimates of abdominal adhesion formation following surgery have been found to be as high as 100 percent in certain studies. Surgery is only recommended for bowel obstruction.


The randomized Henry Ford study looked at 18 women who received the drug or a look-alike placebo. All patients had previous abdominal surgery and were similar in age. The first eight weeks was a randomized placebo controlled trial of pregabalin followed by a four-week open label study in which all patients received the active study drug.


Click the link to read the rest.
http://www.medicalnewstoday.com/articles/168888.php

Pregabalin Side Effects


Brand Names: Lyrica



Please note - some side effects for Pregabalin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).



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Neuropathic Pain Medicine

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Side Effects of Pregabalin - for the Consumer

Pregabalin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pregabalin:



Blurred vision; changes in sexual function; constipation; dizziness; drowsiness; dry mouth; gas; headache; increased appetite; lightheadedness; stomach pain; trouble concentrating; weight gain.



Seek medical attention right away if any of these SEVERE side effects occur when using Pregabalin:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); burning, numbness, or tingling of the hands, feet, or skin; chest pain; confusion; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to control urination; loss of coordination; memory loss; muscle aches, pain, tenderness, or weakness (especially if this occurs with a fever or general feeling or discomfort); new or unusual skin sores; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, feeling "high," behavior changes, suicidal thoughts or attempts); new or worsening seizures; reddened, blistered, swollen, or peeling skin; shortness of breath or wheezing; speaking problems; sudden, unexplained weight gain; swelling of the hands, feet, or ankles; tremor; trouble sleeping; trouble walking; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



Top

Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects including dizziness (up to 38%), somnolence (up to 28%), ataxia (up to 20%), tremor (up to 11%), neuropathy (up to 9%), abnormal thinking (up to 9%), abnormal gait (up to 5%), confusion (up to 7%), speech disorder (up to 7%), amnesia (up to 6%), incoordination (up to 6%), twitching (up to 5%), vertigo (up to 4%), myoclonus (up to 4%), euphoria (up to 3%), and nervousness (up to 1%) have been reported. Anxiety, depersonalization, hypertonia, hypesthesia, decreased libido, nystagmus, paresthesia, stupor, and twitching have been reported frequently. Abnormal dreams, agitation, apathy, aphasia, circumoral paresthesia, dysarthria, hallucinations, hostility, hyperalgesia, hyperesthesia, hyperkinesia, hypokinesia, hypotonia, increased libido, myoclonus, and neuralgia have been reported infrequently. Addiction, cerebellar syndrome, cogwheel rigidity, coma, delirium, delusions, dysautonomia, dyskinesia, dystonia, encephalopathy, extrapyramidal syndrome, Guillain-Barre syndrome, hypoalgesia, intracranial hypertension, manic reaction, paranoid reaction, peripheral neuritis, psychotic depression, schizophrenic reaction, torticollis, and trismus have been reported rarely.



Metabolic

Metabolic side effects including peripheral edema (up to 16%), weight gain (up to 16%), edema (up to 6%), and hypoglycemia (up to 3%) have been reported. Decreased glucose tolerance and urate crystalluria have been reported rarely.



Gastrointestinal

Gastrointestinal side effects including dry mouth (up to 15%), constipation (up to 7%), increased appetite (up to 6%), vomiting (up to 3%), flatulence (up to 3%), nausea and diarrhea have been reported. Gastroenteritis has been reported frequently. Cholecystitis, cholelithiasis, colitis, dysphagia, esophagitis, gastritis, gastrointestinal hemorrhage, melena, mouth ulceration, pancreatitis, rectal hemorrhage, and tongue edema have been reported infrequently. Aphthous stomatitis and esophageal ulcer have been reported rarely.



General

General side effects including infection (up to 14%), accidental injury (up to 11%), headache (up to 9%), asthenia (up to 7%), pain (up to 5%), chest pain (up to 4%), facial edema (up to 3%), flu syndrome (up to 2%), and back pain (up to 2%) have been reported. Abdominal pain and fever have been reported frequently. Abscess, cellulitis, chills, malaise, neck rigidity, overdose, pelvic pain, photosensitivity reaction, and suicide attempt have been reported infrequently. Ascites, granuloma, hangover effect, intentional injury, retroperitoneal fibrosis, shock, and suicide have been reported rarely.



Ocular

Ocular side effects including visual field changes (13%), reduced visual acuity (7%), and blurred vision (6%) have been reported. Conjunctivitis and diplopia have been reported frequently. Abnormality of accommodation, blepharitis, dry eyes, eye hemorrhage, hyperacusis, photophobia, retinal vascular disorder, and retinal edema have been reported infrequently. Anisocoria, blindness, corneal ulcer, exophthalmos, extraocular palsy, iritis, keratitis, keratoconjunctivitis, miosis, mydriasis, night blindness, ophthalmoplegia, optic atrophy, papilledema, parosmia, ptosis, and uveitis have been reported rarely.



Blurred vision resolved in the majority of cases with continued dosing. Less than 1% of patients discontinued pregabalin treatment due to vision related events (primarily blurred vision).



Patients should be informed that they should notify their physician if changes in vision occur. If visual disturbance persists, further assessment should be considered. Furthermore, more frequent assessment should be considered for patients who are already routinely monitored for ocular conditions.



Other

In a cohort study of 333 diabetic patients who received pregabalin for at least 2 years, the average weight gain was 5.2 kg. Pregabalin associated weight gain was related to dose and duration or exposure.



Other side effects including weight gain have been reported. In controlled clinical trials of up to 13 weeks, weight gain of 7% or more over baseline has been reported in 8% of pregabalin-treated patients. Otitis media and tinnitus have been reported frequently. Taste loss, and taste perversion have been reported infrequently.



Cardiovascular

Cardiovascular side effects including edema, primarily peripheral edema (6%) have been reported. Deep thrombophlebitis, heart failure, hypotension, syncope, and postural hypotension have been reported infrequently. Depressed ST and ventricular fibrillation have been reported rarely. There have been postmarketing reports of angioedema.



Specific symptoms of angioedema have included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There have also been reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in patients with these symptoms. Caution is recommended if prescribing pregabalin to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.



Respiratory

Respiratory side effects including dyspnea (up to 3%) and bronchitis (up to 3%) have been reported. Apnea, atelectasis, bronchiolitis, hiccup, laryngismus, lung edema, lung fibrosis, and yawn have been reported rarely.



Genitourinary

Genitourinary side effects including urinary incontinence (up to 2%) have been reported. Anorgasmia, impotence, and urinary frequency have been reported frequently. Abnormal ejaculation, albuminuria, amenorrhea, dysmenorrhea, dysuria, hematuria, kidney calculus, leukorrhea, menorrhagia, metrorrhagia, nephritis, oliguria, and urinary retention have been reported infrequently. Acute kidney failure, balanitis, bladder neoplasm, cervicitis, dyspareunia, epididymitis, female lactation, and glomerulitis have been reported rarely. Two cases of unilateral painful gynecomastia have also been reported.



Musculoskeletal

Musculoskeletal side effects including myasthenia (1%) have been reported. Arthralgia, leg cramps, myalgia, and myasthenia have been reported frequently. Arthrosis has been reported infrequently. Generalized spasm has been reported rarely.



Oncologic

Oncologic side effects including an unexpectedly high incidence of hemangiosarcoma have been reported in animal studies after pregabalin was given their diet for two years. In clinical studies comprised of 6,396 patient-years of exposure, new or worsening-preexisting tumors were reported in 57 patients. It is not known if the incidence seen in these clinical studies is or is not affected by treatment.



Hypersensitivity

Hypersensitivity side effects including allergic reactions have been reported frequently. Allergic reactions have included skin redness, blisters, hives, rash, dyspnea, and wheezing. Pregabalin should be discontinued immediately in patients with these symptoms. Anaphylactoid reactions have been reported rarely.



Hematologic

Hematologic side effects including ecchymosis have been reported frequently. Anemia, eosinophilia, hyperchromic anemia, leukocytosis, leukopenia, lymphadenopathy, and thrombocytopenia have been reported infrequently. Myelofibrosis, polycythemia, decreased prothrombin, purpura, and thrombocytopenia have been reported rarely.



Dermatologic

Dermatologic side effects including pruritus have been reported frequently. Alopecia, dry skin, eczema, hirsutism, skin ulcer, urticaria, and vesiculobullous rash have been reported infrequently. Angioedema, exfoliative dermatitis, lichenoid dermatitis, melanosis, petechial rash, purpuric rash, pustular rash, skin atrophy, skin necrosis, skin nodule, Stevens-Johnson syndrome, and subcutaneous nodule have been reported rarely.

From Drugs.com

Pregabalin relieves discomfort from abdominal adhesions, study finds

Posted On: October 26, 2009 - 3:30pm
DETROIT – Pregabalin, FDA-approved for neuropathic pain (pain caused by shingles and peripheral neuropathy), effectively reduced abdominal pain and improved sleep in women with adhesions, according to a Henry Ford study.
Adhesion pain, a common complication after abdominal or pelvic surgery, currently lacks effective therapy. Adhesions can also form after infections in the bowel such as diverticulitis.
"Many patients in the study went from debilitating pain to complete resolution of pain on pregabalin," says Ann Silverman, M.D., senior staff gastroenterologist at Henry Ford Hospital and lead author of the study.
Study results will be presented Oct. 26 at the American College of Gastroenterology's Annual Scientific Meeting in San Diego.
"Aside from the use of analgesics, additional surgery is the only treatment option for abdominal pain from adhesions but repeat surgery can lead to more adhesions," says Dr. Silverman.
The estimates of abdominal adhesion formation following surgery have been found to be as high as 100 percent in certain studies. Surgery is only recommended for bowel obstruction.
The randomized Henry Ford study looked at 18 women who received the drug or a look-alike placebo. All patients had previous abdominal surgery and were similar in age. The first eight weeks was a randomized placebo controlled trial of pregabalin followed by a four-week open label study in which all patients received the active study drug.
The primary objective was to demonstrate a significant reduction in pain scores.
The pain score result from the blinded phase indicated that the amount of decrease was significantly greater in the drug group (p-value = 0.024) compared with those on placebo, while the pain score resulted from the open label setting indicated that the amount of decrease was significantly greater in the placebo group (p-value = 0.043). This would be expected since those on active drug continued to take active drug and patients who had received the look-alike placebo received the active drug only during this phase of the study.



Source: Henry Ford Health System
Link to article

News you can use ARDvark Blog

Gut Bacterium Linked To Colon Cancer
Written by Catharine Paddock, PhD
US scientists found that a common bacterium found in the gut could play a role in the development of colon cancer by producing a fermentation byproduct that damages DNA and affects signalling pathways used by colon cancer...[read article]Gut Bacterium Linked To Colon Cancer

Introducing NEW Voltarol Pain-eze® Tablets - A New And Effective Way Of Treating Body Pain Voltarol® Launches First Ever OTC Diclofenac Tablet

Pelvic Disorders Affect Large Number Of Women

Stateline.org Examines State Ballot Measures Related To Health Care

Introducing NEW Voltarol Pain-eze® Tablets - A New And Effective Way Of Treating Body Pain Voltarol® Launches First Ever OTC Diclofenac Tablet

Gordon Brown Praises NHS Staff On Reductions In C. Difficile And MRSA Infections, UK

Vaginal Brachytherapy Versus External Beam Pelvic Radiotherapy For High-Intermediate Risk Endometrial Cancer - Randomised PORTEC-2 Trial

Could An Absorption Enhancer Be More Convenient And Helpful For Colitis Patients?

Editorial: Where's The Data? Association Of Faculties Of Medicine Of Canada

In Crohn's Disease A Case Of False Positive Octreoscan

Canadian Scientists Report On Pain Research At NIDCR's 60th Anniversary Symposium

Montreal Water Treatment Plants Dumping As Much As 90 Times The Critical Amount Of Estrogen Products Into The River

Suppressing Hunger Hormone Could Be As Effective As Bariatric Surgery

What Impact Does "Fertility Tourism" Have On The NHS?

Discovery Of Master Switch In The Brain That Regulates Appetite And Reproduction

Adhesion News ARDvark Blog

Published Date: 08 September 2008
By Joanne Mead
DOCTORS could have saved a woman's life if they had operated sooner, an inquest heard.
Coroner Roger Whittaker recorded this in a narrative verdict at the hearing into the death of Shirley Vernon, 62, on November 30, 2005.She died two weeks after surgery at Calderdale Royal Hospital.
Read More
Milk May Help Bacteria Survive Against Low Levels Of Antibiotics

Superbug Bacteria Use Rattlesnake-Type Poisons To Beat Our Defenses

Recommended Follow-Up Care Lacking In Many Colorectal Cancer Survivors

New Diet Unveiled To Save Millions Of PMS Sufferers

Coated Catheters Reduce Infection Risk

Record $181 Million Grant To Evaluate Health, Poverty And Gender Programs Worldwide, Received By UNC

2008 Da Vinci Awards For Wheelchair Enhancing Ideas - National MS Society Celebrating New Adaptive, Assistive Technologies

Hopeful Medical Industry News On Malpractice Premiums For Physicians Is Released For 2008

Fresh Medical Industry News Reveals Earnings & Productivity Changes For Physicians

New Low Dose Oral Contraceptive YAZ® Launched In Europe

Restech Dx-pH Measurement System Proven To Facilitate Accurate Measurement Of Acid Exposure In Patients With Reflux Related Symptoms

Early Onset Gene For Inflammatory Bowel Diseases Identified

Discovery Of Master Switch In The Brain That Regulates Appetite And Reproduction

Find out about ARD, before you have any surgery!

September is Adhesion Related Disorder Awareness Month.

What are Adhesions?
An ADHESION is a type of scar that forms an abnormal connection between two parts of the body. Adhesions can cause severe clinical problems. For example, adhesions involving the female reproductive organs (ovaries, Fallopian tubes) can and do cause infertility, dyspareunia (painful intercourse) and debilitating pelvic pain. Adhesions involving the bowel can cause bowel obstruction or blockage. Adhesions may form elsewhere such as around the heart, spine and in the hand where they lead to other problems.
Adhesions occur in response to injury of various kinds. For example, non-surgical insults such as endometriosis, infection, chemotherapy, radiation and cancer may damage tissue and initiate ADHESIONS. By far the most common kind of ADHESION is the one that forms after surgery. ADHESIONS typically occur at the site of a surgical procedure although they may also occur elsewhere.

Dr. David Wiseman - International Adhesions Society

Please visit these site for advocacy news and general education.
International Adhesion Society

United Kingdom Adhesion Society

Adhesion Related Disorder
GynSurgery website
ARDchat.com

ARDvark Blog

EndoTimes

Education helps prevent Adhesions!

Protect yourself from Medical Marketing

See this CNN podcast. It is critical that you consider the steps offered to protect yourself from Medical Marketing.

Who is wooing your doctor?

"Linda Lewis says that when she had back surgery two years ago, her surgeon didn't do what was best for her health; he did was best for his bank account."

Story Highlights

Expert: Research shows that financial ties to drug, device makers influence doctors

Last year, five companies were ordered to disclose payments to physicians

Drugs taken long term are heavily marketed to doctors; short-term drugs less so

Another consideration adhesion patients must face.

After Scar II

Self explanatory
The steps leading to the formation of adhesions and some of the factors that can influence the development of adhesions during surgery are illustrated.
How adhesions develop:
The tissue surface becomes damaged, either through surgery or injury, leading to disruption of the mesothelial lining
Bleeding and leakage of plasma proteins lead to fibrin deposits at injured sites, which is augmented by post-traumatic inflammation
The enlarging fibrin mesh might attach to an adjoining surface, a process that is counteracted by locally generated fibrinolytic factors
Depending on local peritoneal conditions, the fibrin mesh could either be degraded, resulting in scarless repair, or transformed into an adhesion consisting of connective tissue
If the fibrin is degraded within the first few days, the defect heals scarlessly
If remnants of fibrin remain for long enough, recruited reparative cells transform the initially reversible fibrinous adhesion to a fibrous, collagen-containing structure
Various factors can influence the development of adhesions during surgery - e.g. infection, heat, light, glove powder.
From the basic processes that result in the formation of adhesions, there are various steps that can be taken during surgery to minimise the risk of adhesions
These are:
increase vascular permeability
reduce infection risk
avoid GI contamination
minimise tissue handling by careful technique and microsurgery
reduce drying of tissues by using lubrication
limit use of cautery
limit use of sutures
avoid materials with fibres
use starch-free gloves
Although these measures will minimise the risks, they cannot eliminate the problem completely
Thus there is a clear need for improved adhesion-reduction strategies
Adhesion-reduction strategies involve:
Careful surgical technique
Minimisation of inflammatory response by use of
corticosteroids
NSAIDs
antibiotics
Augmentation of fibrinolysis
tissue plasminogen activator
Use of various adhesion-reduction agents
Risberg B. Eur J Surg 1997;577:32-39
Risberg reviewed a number of adhesion prevention strategies and techniques. The two major prevention strategies discussed are (1) adjusting surgical technique and (2) application of adjuvants.
NSAIDs (e.g. ibuprofen, tolmetin and oxyphenbutazone) can be applied systematically as well as intraperitoneally. Clinically efficacy remains questionable possibly because of drug delivery difficulties.
Corticosteroids (dexamethasone, hydrocortisone and prednisolone) can be administered intraperitoneally. Efficacy is doubtful due to associations with immunosuppression and delayed wound healing, e.g. infection, incisional hernia and wound dehiscence. Also, they do not remain in the peritoneal cavity for the duration of adhesion formation (4-5 days post surgery)
Fibrinolytics are designed to prevent or reverse fibrin deposition. Intraperitoneally or systematically administered plasminogen activator (tPA), streptokinase and elastase have undergone considerable laboratory evaluation with conflicting results, and in some cases, haemorrhagic complications. This lack of efficacy may be attributable to the problem of rapid peritoneal absorption and clearance.
To assess European opinion on post-operative adhesions two surveys were conducted, one at ESHRE 2002 (European Society of Human Reproduction and Embryology) and EACP (European Association of Coloproctology).
The respondents from ESHRE were all gynaecologists and results were as follows:
14.2% of respondents cited safety as an attribute associated with an ideal anti-adhesion agent
13.4% cited effectiveness
36.2% cited ease of use
15.7% cited low cost
Published in ANV 4
Note:
Preclude is referenced as ‘generally unavailable’ as clinical experience shows there are limitations in its use.
Hyskon is included in this slide as there is anecdotal evidence to suggest off-license use. However, cases of anaphylaxis have been recorded.
Mathias Korell – well recognised German gynae laparoscopy specialist has done studies with Spraygel and uses in endometriosis cases – where they do a lot of surgery (like colorectal in terms of extent of work in the abdomen – ie not neat and dainty stuff) and he is quoting need 5 kits to then coat the peritoneum to ensure adequate coverage – will be in Adhesions News & Vies Issue 5
Cost they quote around £150/sheet that would be a good size in abdominal surgery – but they won’t be more specific or detail how many sheets a colorectal surgeon might need to use
Adept® (icodextrin 4%) is a new potential solution to adhesions
Adept is approved throughout Europe for use in abdominal and pelvic surgery as an intraoperative wash and postoperative instillate for the reduction of adhesions
It is available as a 1 litre bag and most recently as a 1.5 litre bag to allow use of one bag for irrigating during surgery and to provide 1000ml to leave behind as a postoperative instillate
Work from a registry of routine use (ARIEL) which is now progressing in 150+ centres in Europe showed that a 1.5 litre presentation of Adept would be useful for most surgical cases allowing surgeons to irrigate with up to 500ml during surgery and then instil 1000ml to leave behind at the end of surgery
Icodextrin is a  1,4 linked glucose polymer
The structure is different from Dextran; the key difference lies in the linkage of carbon 1 and 4 (versus Dextran 1,6 which the human body cannot break down easily)
Icodextrin was developed from hydrolysis of corn starch (so it is a natural product)
Icodextrin is used for adhesion reduction as a 4% solution
This 4% solution is isosmolar and biocompatible with other drugs
Icodextrin is a large polymer and attracts a ‘water of hydration’ around it, increasing its size still further.
It is absorbed from the abdomino–pelvic cavity by the lymphatic system. In the blood it is broken down readily by amylase (acts on the 1,4 link) to maltose/isomaltose and then glucose, and is then excreted
Icodextrin has a well-established safety profile at the higher concentration of 7.5% where it is used in peritoneal dialysis - with > 36,000 patient years of safety data and use of Adept in >50,000 as at end January
Icodextrin was developed originally to overcome the issues associated with existing peritoneal dialysis fluids, specifically irritation to the peritoneum, etc
As a result of its structure, icodextrin with its ‘water of hydration’ stays in the abdomino–pelvic cavity over time (it is absorbed solely by the lymphatic system). It is this persisting presence in the abdomino–pelvic cavity that is thought to reduce adhesion formation/reformation as a result of ‘hydroflotation’
Hydroflotation is not a new concept, but the problem has been in finding a fluid that would stay in the abdomino–pelvic cavity long enough to keep tissues apart in the critical time after surgery when adhesions develop, but which does not have an irritant effect on the peritoneum, nor causes problems when absorbed (e.g. Dextran)
This slide looks at the persistence of 4% icodextrin over time compared to saline and glucose
It comes from a study in patients receiving peritoneal chemotherapy in whom 4% icodextrin was used as the carrier fluid1. In the periods between chemotherapy the icodextrin was used as a ‘dwell’ and aliquots drawn off through the Tenckhoff catheter
The results show that 50% of the icodextrin 4% solution was still retained after ~92+ hours, whereas within a day all the saline or glucose was absorbed by the lymphatics
This is the reason why crystalloid solutions such as saline are not very effective in the reduction of adhesions, as they do not stay in the abdomen for long enough to keep the organs and tissues ‘hydroflotated’
Reference
1. Hosie K, Gilbert JA, Kerr D et al. Fluid dynamics in man of an intraperitoneal drug delivery solution: 4% icodextrin. Drug Delivery 2001; 8: 9–12.
Video clips showing instillation at end of surgery
This slide shows the cost comparison of recent agents at current UK prices
Note the costs of agents is different in Finland but comparatively the relative price differentials will be the same
Two kits of Spraygel are often used to get adequate coverage of the surgical site and as per Prof Mathias Korell’s experience in major gynaecological surgery – 5 kits may be needed to ensure adequate coverage of the peritoneal cavity!
The US outcomes study with Seprafilm is using a mean 4.4 sheets/patients1
Intergel was withdrawn in April 2003
Reference
1. Beck DE, Cohen Z, Fleshman JW, Kaufman HS, vanGoor H, Wolff BG. Prospective, randomized, multicentre, controlled study of the safety of Seprafilm Adhesion Barrier in abdominopelvic surgery. Dis Colon Rectum 2003
This slide shows the cost comparison of recent agents at current UK prices illustrating costs of using 4.4 sheets Seprafilm (as per Beck) and 5 kits of Spraygel as (per Korell).
SurgiWrap not included as they don’t give a precise list price or how many sheets are used – when asked – and ?? Anyone using it yet??
Wilson MS et al. Colorectal Disease 2002;4:355-360
Wilson et al. modelled data from a lower abdominal surgery cohort from the SCAR data to assess cost effectiveness.
Results showed that:
Routine use of adhesion reduction products costing £50 per patient will payback the cost for such investment if they reduce adhesion-related readmissions by 16% after 3 years
A product costing £200 will need to offer a 64.1% reduction in readmissions after 3 years to recoup its direct costs
For the estimated 158,000 lower abdominal surgery operations conducted in the UK each year the cumulative costs of adhesion related readmissions over 10 years are estimated at £569 million
At year 3 – 64% reduction would be needed
And at 3 years
Wilson MS et al. Colorectal Disease 2002;4:355-360
Wilson et al. modelled data from a lower abdominal surgery cohort from the SCAR data to assess cost effectiveness.
Results showed that:
Routine use of adhesion reduction products costing £50 per patient will payback the cost for such investment if they reduce adhesion-related readmissions by 16% after 3 years
A product costing £200 will need to offer a 64.1% reduction in readmissions after 3 years to recoup its direct costs
For the estimated 158,000 lower abdominal surgery operations conducted in the UK each year the cumulative costs of adhesion related readmissions over 10 years are estimated at £569 million
This slide looks at cumulative costs of using an adhesion reduction agent over 9 years scaling up to the UK as a whole.
Using a £50 agent with a 25% efficacy would result in a saving of £71m
But using a £200 product with similar efficacy would result in a £142m loss – ie the health system would have to spend an extra £142m over the 9 years to reduce adhesion related readmissions by 25%.
In only 10.4% of cases were adhesions mentioned as part of the informed consent process
14.4% adhesions were discussed but not part of the consent
In those undergoing specific adhesiolysis operations 54% of patients reported being given some kind of information on adhesions before surgery
46% were given information on anti-adhesion agents
In procedures not involving adhesiolysis only 10% of patients reported receiving any adhesion information
Only 6% of cases were given information on anti-adhesion agents
Is this acceptable practice?
Most common adhesion-related claims
Failure to diagnose adhesion-related problems
Delay in diagnosis
Bowel damage at adhesiolysis
– laparoscopy > laparotomy
Infertility or risk of infertility
Starch granuloma – (use of starch-powdered gloves)
Failure to take precautions to prevent adhesions
1994 -1999 UK Medical Defence Union received 77 adhesion-related claims
Out of court settlements in 14 cases in 11 years ranged from £7960 - £124,261 (~€11,701 - €182,664)
– average £50,765 (€74,625)/case
And that was up until 1999
Since 1999
More evidence of burden of adhesions
SCAR study
Van Krabben enterotomy risk
SCAR-2
etc
Discuss high risk options then lead to prohylaxis

Before SCAR
Before we knew the real extent of the problem
Before we had newer anti-adhesion agents
Adhesions continue to be a significant burden
For the patient:
pain, SBO, infertility, re-operative complications
For the surgeon
increased workload, lengthy and complex procedures, medicolegal consequences
For the healthcare system
increased workloads, costs, bed stay

Where are we now?
Any advances in surgery have had little impact
Action on adhesions has received low priority
even in high risk procedures
New developments in anti-adhesion agents

not all are difficult or costly to use
emerging evidence of efficacy
Adopt use of anti-adhesion agents in ‘High Risk’ surgery
Adhesiolysis
Small bowel resection
Formation of stoma
Hartmann’s procedure
Anterior resection
Abdomino-perineal excision
Colectomy
Surgical treatment of peritonitis & fistulae

Thank you
Fellow SCAR Panel Members
Prof Harold Ellis, UMDS, London
Malcolm Wilson, Christie Hospital, Manchester
Don Menzies, Colchester Hospital, Colchester
Jeremy Thompson, Chelsea & Westminster Hospital, London
Brendan Moran, North Hampshire Hospital, Hampshire
Adrian Lower, St Bartholomew's Hospital, London
Rob Hawthorn, Southern General Hospital, Glasgow
Prof Alastair McGuire, City University, London
Graham Sunderland, Southern General Hospital, Glasgow
David Clark, James Boyd, Alan Finlayson, ISD, NHS Scotland, Edinburgh
Prof Ian Ford, Robertson Centre Biostatistics, Glasgow
Alastair Knight & Alison Crowe, Corvus
Shire Pharmaceuticals Group plc
Powerpoint template

Please read more
http://www.euuzlet.hu/koloproktologus/2004/parker.ppt.

The defamation of service dogs.

Many disabled people rely on their service dogs to have any quality of life.

They are hard to come by and the more successful breeds are highly trainable and working is their joy.

Labs
German Shepard's
Doberman Pincher's.
Poodles
Too many to mention, even mutts!


We would just like to point out how a cheesy, ad campaing can compromise the service dogs ability to perform in public.

These dogs are also some of the greatest hero's of our country serving police and military.

Please stick up for service dogs as they will always be there for you.

Contact these people and tell them how you feel about their portrayal of service dogs.

Thank you for your message of concern about our current televisioncommercial that features a Doberman. We appreciate feedback from thepublic and we share it with our advertising agency.It is certainly not Alltel's intention to offend any particular breed ofdog and/or their owners. If this has happened we apologize. Our currenttelevision ad features a well-behaved and highly trained animal actorsimply playing a fictional role, as has been done in movies and ontelevision for years. We view this no differently than human actorsplaying roles opposite their true personality. Alltel continues to standbehind its current advertising campaign. Paul SageMarketing CommunicationsAlltel

http://us.f656.mail.yahoo.com/ym/Compose?To=corp.corporate.communications@alltel.com ; http://us.f656.mail.yahoo.com/ym/Compose?To=andrew.moreau@alltel.com ; http://us.f656.mail.yahoo.com/ym/Compose?To=lucie.r.pathmann@alltel.com , http://us.f656.mail.yahoo.com/ym/Compose?To=Paul.Sage@alltel.com

There are no bad dogs.....only bad owners!

Please visit Pathway to Hope's Prison Dog Program
http://www.picturetrail.com/gallery/view?p=999&gid=6681339&uid=989068
and
http://www.picturetrail.com/gallery/view?p=999&gid=1839198&uid=989068

Serious Illness? Learn How to Navigate the Health Care System

David Landay's Parental and Partner Losses Prompted His Consumer-Oriented Site

Hit Broadway producer David Landay watched cancer kill both his parents and HIV/AIDS snatch several close friends, and eventually his partner.
It seemed that dealing with death had become a frequent and unwanted aspect of his life.
"It was so common that my friend Sally came home and found this note on her refrigerator: 'Rich called. John is dead.' And it had just become that common," he said. "My partner David died, and after that, I decided I had to help full-time."
After navigating the difficult pathway of serious illness and the health care system, Landay wanted to help others do the same. So he launched a Web site, survivorshipatoz.org.
He developed the site to serve as a one-stop shop to help people dealing with cancer, AIDS or any other serious illness as they navigate the health care system.
"The idea would be to give people all the legal, financial and practical information they need; so that when you first got that diagnosis and all these questions come charging at you, the answers would all be there," said Landay, who produced the Broadway show "Woman of the Year" with Lauren Bacall, Raquel Welch and Debbie Reynolds.
He recognized that when people get hit with devastating news they are often are confused about what to do. They may not have enough savvy about the health care industry to debunk common myths.
"Health insurance is the most important asset you have, but one of the myths is you can't get it. Well, you still can get health insurance," Landay said.
Even with health coverage, meeting medical financial obligations can be difficult.

Read the rest and watch podcast. Click Here

Help advance pain care in our country

Take Action Now
Make Your Voice Heard!
Join forces with APF, other organizations and thousands of others across the United States who are committed to raising public awareness and promoting the best pain policy, legislation and practice.By uniting, mobilizing and leveraging our collective voices, we can improve pain management. It is not acceptable that 76 million Americans suffer pain and the majority do not receive appropriate care! Click here for more information on the latest National Pain Legislation and how you can Make Your Voice Heard!

There are FOUR critical actions you can take right now that will help advance pain care in our country.

Ask your Representative to co-sponsor the National Pain Care Policy Act of 2007 (HR 2994) - CLICK HERE.
The Veterans Pain Care Act, HR 6122, was introduced in the House of Representatives - CLICK HERE.
Request that your organization endorse the Consensus Statement for the National Pain Care Policy Act of 2007 - CLICK HERE.
Request that your organization endorse the Consensus Statement for the Military and Veterans Pain Care Acts - CLICK HERE.

From: The American Pain Foundation