Saturday, December 30, 2006
Adhesion Related Disorder ARDvark Blog News
New Technology Makes Clinical Research More Precise
Controlling Drug Design Through 'unnatural' Selection
How Does A Zebrafish Grow A New Tail? The Answer May Help Treat Human Injuries
Women On Osteoporosis Drug Can Discontinue Use With No Risk
The Repertoire Of RNAs In Nerve Cell Processes
Gene Chip Technology Shows Potential For Identifying Life-Threatening Blood Infection
Doing It Right: New Book Helps Biologists Conduct Rigorous And Reliable Research
Impulsiveness Linked To Activity In Brain's Reward Center
Electrical Activity Alters Language Used By Nerve Cells
Study Gives Clues About How Deadly Bacterium Gains Foothold
Regular Vigorous Housework Can Reduce Some Types Of Bowel Cancer Risk
Grain And Berry Phytoestrogens May Affect Cancer Risk Through The Estrogen Signalling System
FDA Updates Its Nationwide Alert On Counterfeit One Touch Blood Glucose Test Strips - Actions Constitute A Class I Recall
Inflammatory Genes Linked To Salt-sensitive Hypertension
Pain Relief Effectiveness Down To Mind-Set?
Skin Atrophy Reversed By Hyaluronate
Controlling Drug Design Through 'unnatural' Selection
How Does A Zebrafish Grow A New Tail? The Answer May Help Treat Human Injuries
Women On Osteoporosis Drug Can Discontinue Use With No Risk
The Repertoire Of RNAs In Nerve Cell Processes
Gene Chip Technology Shows Potential For Identifying Life-Threatening Blood Infection
Doing It Right: New Book Helps Biologists Conduct Rigorous And Reliable Research
Impulsiveness Linked To Activity In Brain's Reward Center
Electrical Activity Alters Language Used By Nerve Cells
Study Gives Clues About How Deadly Bacterium Gains Foothold
Regular Vigorous Housework Can Reduce Some Types Of Bowel Cancer Risk
Grain And Berry Phytoestrogens May Affect Cancer Risk Through The Estrogen Signalling System
FDA Updates Its Nationwide Alert On Counterfeit One Touch Blood Glucose Test Strips - Actions Constitute A Class I Recall
Inflammatory Genes Linked To Salt-sensitive Hypertension
Pain Relief Effectiveness Down To Mind-Set?
Skin Atrophy Reversed By Hyaluronate
Abdominal Adhesions
What Is It?
Symptoms
Diagnosis
Expected Duration
Prevention
Treatment
When To Call A Professional
Prognosis
Additional Info
What Is It?
Abdominal adhesions are bands of fibrous scar tissue that form on organs in the abdomen, causing the organs to stick to one another or to the wall of the abdomen. In people living in developed countries, this scar tissue most commonly develops after abdominal surgery, in which organs are handled by the surgical team and are shifted temporarily from their normal positions. It can also form in people who develop peritonitis, an infection that has spread to the membrane that covers the abdominal organs. Peritonitis commonly occurs after appendicitis or another abdominal infection. Another cause of adhesions is endometriosis, an inflammatory condition that affects some women and may involve the abdomen and serious abdominal trauma.
In most patients, adhesions do not cause health problems. In a small number of people who have adhesions, however, the fibrous bands of scar tissue block the intestines either completely or partially. This blockage is called a bowel obstruction, and it leads to death in about 5% of cases. Sometimes, an area of intestine that is affected by adhesions can keep becoming blocked then unblocked, causing symptoms to come and go. In about 10% of small-bowel obstructions, a portion of the bowel twists tightly around a band of adhesions. This cuts off the normal blood supply to the twisted bowel, causing what is called strangulation, and that section of bowel begins to die. When this emergency happens, the person must be taken to surgery immediately. The death rate is as high as 37% in people who develop strangulation.
Adhesions are fairly rare in patients who have never had abdominal surgery. In people who have had multiple abdominal surgeries, adhesions are common.
Symptoms
In most people, abdominal adhesions do not cause any symptoms. Adhesions that partially block the intestine from time to time can cause intermittent bouts of crampy abdominal pain.
More significant intestinal obstruction can cause the following symptoms:
Severe, crampy abdominal pain
Nausea and vomiting
Swelling of the abdomen (abdominal distension)
Inability to pass gas and absent or infrequent bowel movements
Signs of dehydration, including dry skin, dry mouth and tongue, severe thirst, infrequent urination, fast heart rate and low blood pressure
If the bowel becomes strangulated, people typically develop severe abdominal pain, which can be either crampy or constant. The abdomen is distended and tender when touched even lightly. People with a strangulated bowel usually also develop signs of systemic (body-wide) illness, such as fever, fast heart rate and low blood pressure.
Diagnosis
Your doctor will examine you, paying special attention to your abdomen. He or she also will examine your rectum. If you are a woman, your doctor will do a pelvic exam. To find further evidence for the diagnosis, your doctor will order blood tests and X-rays of your chest and abdomen. In some people with suspected intestinal obstruction or strangulation, the diagnosis can be confirmed only at the time of abdominal surgery.
Expected Duration
Abdominal adhesions are permanent unless the patient has a surgical procedure, called adhesion lysis. During this operation, a surgeon uses instruments to clip the fibers that have formed into adhesions and to remove as much of this scar tissue as possible.
Prevention
There is no way to prevent adhesions. This is one reason that doctors recommend abdominal surgery only when absolutely necessary. If you are having abdominal surgery, your surgeon can minimize the risk of adhesions by using a gentle surgical technique and powder-free gloves.
Treatment
Small-bowel obstructions that are caused by adhesions require surgery in almost every case. In cases of partial bowel obstruction or complete bowel obstruction without severe symptoms, surgery may be delayed for 12 to 24 hours to allow a dehydrated patient to receive fluids intravenously (into a vein) prior to the operation. In this case, a small suction tube that extends through the nose and into the stomach can be used to prevent additional bloating and to relieve pain and nausea. When adhesions cause intestinal strangulation, immediate abdominal surgery is required to remove the adhesions so that blood flow to the bowel can be restored.
When To Call A Professional
Call your doctor whenever you have severe abdominal pain, especially if you also have a fever, nausea and vomiting, or infrequent bowel movements.
Prognosis
Abdominal adhesions can be treated, but they can be a recurring problem. Because surgery is both the cause and the treatment, the problem can keep returning. For example, when surgery is done to remove an intestinal obstruction caused by adhesions, adhesions form again and create a new obstruction in 11% to 21% of cases.
Additional Info
National Digestive Diseases Information Clearinghouse (NDDIC)2 Information WayBethesda, MD 20892-3570Toll-Free: 1-800-891-5389Phone: 301-654-3810Fax: 301-907-8906Email: nddic@info.niddk.nih.govhttp://digestive.niddk.nih.gov/
Symptoms
Diagnosis
Expected Duration
Prevention
Treatment
When To Call A Professional
Prognosis
Additional Info
What Is It?
Abdominal adhesions are bands of fibrous scar tissue that form on organs in the abdomen, causing the organs to stick to one another or to the wall of the abdomen. In people living in developed countries, this scar tissue most commonly develops after abdominal surgery, in which organs are handled by the surgical team and are shifted temporarily from their normal positions. It can also form in people who develop peritonitis, an infection that has spread to the membrane that covers the abdominal organs. Peritonitis commonly occurs after appendicitis or another abdominal infection. Another cause of adhesions is endometriosis, an inflammatory condition that affects some women and may involve the abdomen and serious abdominal trauma.
In most patients, adhesions do not cause health problems. In a small number of people who have adhesions, however, the fibrous bands of scar tissue block the intestines either completely or partially. This blockage is called a bowel obstruction, and it leads to death in about 5% of cases. Sometimes, an area of intestine that is affected by adhesions can keep becoming blocked then unblocked, causing symptoms to come and go. In about 10% of small-bowel obstructions, a portion of the bowel twists tightly around a band of adhesions. This cuts off the normal blood supply to the twisted bowel, causing what is called strangulation, and that section of bowel begins to die. When this emergency happens, the person must be taken to surgery immediately. The death rate is as high as 37% in people who develop strangulation.
Adhesions are fairly rare in patients who have never had abdominal surgery. In people who have had multiple abdominal surgeries, adhesions are common.
Symptoms
In most people, abdominal adhesions do not cause any symptoms. Adhesions that partially block the intestine from time to time can cause intermittent bouts of crampy abdominal pain.
More significant intestinal obstruction can cause the following symptoms:
Severe, crampy abdominal pain
Nausea and vomiting
Swelling of the abdomen (abdominal distension)
Inability to pass gas and absent or infrequent bowel movements
Signs of dehydration, including dry skin, dry mouth and tongue, severe thirst, infrequent urination, fast heart rate and low blood pressure
If the bowel becomes strangulated, people typically develop severe abdominal pain, which can be either crampy or constant. The abdomen is distended and tender when touched even lightly. People with a strangulated bowel usually also develop signs of systemic (body-wide) illness, such as fever, fast heart rate and low blood pressure.
Diagnosis
Your doctor will examine you, paying special attention to your abdomen. He or she also will examine your rectum. If you are a woman, your doctor will do a pelvic exam. To find further evidence for the diagnosis, your doctor will order blood tests and X-rays of your chest and abdomen. In some people with suspected intestinal obstruction or strangulation, the diagnosis can be confirmed only at the time of abdominal surgery.
Expected Duration
Abdominal adhesions are permanent unless the patient has a surgical procedure, called adhesion lysis. During this operation, a surgeon uses instruments to clip the fibers that have formed into adhesions and to remove as much of this scar tissue as possible.
Prevention
There is no way to prevent adhesions. This is one reason that doctors recommend abdominal surgery only when absolutely necessary. If you are having abdominal surgery, your surgeon can minimize the risk of adhesions by using a gentle surgical technique and powder-free gloves.
Treatment
Small-bowel obstructions that are caused by adhesions require surgery in almost every case. In cases of partial bowel obstruction or complete bowel obstruction without severe symptoms, surgery may be delayed for 12 to 24 hours to allow a dehydrated patient to receive fluids intravenously (into a vein) prior to the operation. In this case, a small suction tube that extends through the nose and into the stomach can be used to prevent additional bloating and to relieve pain and nausea. When adhesions cause intestinal strangulation, immediate abdominal surgery is required to remove the adhesions so that blood flow to the bowel can be restored.
When To Call A Professional
Call your doctor whenever you have severe abdominal pain, especially if you also have a fever, nausea and vomiting, or infrequent bowel movements.
Prognosis
Abdominal adhesions can be treated, but they can be a recurring problem. Because surgery is both the cause and the treatment, the problem can keep returning. For example, when surgery is done to remove an intestinal obstruction caused by adhesions, adhesions form again and create a new obstruction in 11% to 21% of cases.
Additional Info
National Digestive Diseases Information Clearinghouse (NDDIC)2 Information WayBethesda, MD 20892-3570Toll-Free: 1-800-891-5389Phone: 301-654-3810Fax: 301-907-8906Email: nddic@info.niddk.nih.govhttp://digestive.niddk.nih.gov/
Thursday, December 28, 2006
ARDvark Blog Adhesion Related Disorder
Serious And Deadly ICU Blood Infections Could Be Cut By Two Thirds With Basic Training
A US pilot study suggests that training staff to stick to basic hygiene measures like routine handwashing and following inexpensive, common sense guidelines, could reduce catheter-related blood infections in the ICU by up to 66 per cent...[read article]
Professors To Develop Hand-Held Pathogen Testing Device
First Familial Pancreatic Cancer Gene Identified
Medicare Publishes New Hospital Requirements, USA
Transmission Routes For The Bacterium Campylobacter
Humour Helps You Live Longer
FDA Approves First Generic Bupropion Hydrochloride Extended-Release Tablets
ESRC Genomics Network Responds To Decision To Extend Egg Sharing Licence
FDA Approves New Indication For INVANZ® (ertapenem) For The Prevention Of Surgical Site Infections Following Elective Colorectal Surgery In Adults
A US pilot study suggests that training staff to stick to basic hygiene measures like routine handwashing and following inexpensive, common sense guidelines, could reduce catheter-related blood infections in the ICU by up to 66 per cent...[read article]
Professors To Develop Hand-Held Pathogen Testing Device
First Familial Pancreatic Cancer Gene Identified
Medicare Publishes New Hospital Requirements, USA
Transmission Routes For The Bacterium Campylobacter
Humour Helps You Live Longer
FDA Approves First Generic Bupropion Hydrochloride Extended-Release Tablets
ESRC Genomics Network Responds To Decision To Extend Egg Sharing Licence
FDA Approves New Indication For INVANZ® (ertapenem) For The Prevention Of Surgical Site Infections Following Elective Colorectal Surgery In Adults
Giving your Informed Consent
Before having your operation, you will be asked to indicate that you understand the nature of the surgical procedure to be performed and that you give your permission for the operation.
This may appear to be a formality, but, in fact, this process should be taken very seriously. Before your operation, frankly discuss with your surgeon any questions or concerns that you have. Of course, not everyone wants to know all the specific details of the surgical procedure itself, but you should seek the answers to questions such as:
Questions
Principle of informed consent
Surgery by Surgeons
What are the indications that have led your doctor to the opinion that an operation is necessary?
What, if any, alternative treatments are available for your condition?
What will be the likely result if you don't have the operation?
What are the basic procedures involved in the operation?
What are the risks?
How is the operation expected to improve your health or quality of life?
Is hospitalization necessary and, if so, how long can you expect to be hospitalized?
What can you expect during your recovery period?
When can you expect to resume normal activities?
Are there likely to be residual effects from the operation?
Of course, your surgeon may volunteer much of this information. However, if you still have questions, don't hesitate to ask. Remember, the operation is being performed on you, and you should seek any information that you need to improve your understanding. Your doctor should be willing to take whatever time is necessary to make sure that you are fully informed. No doctor can, or should, guarantee outcomes, because each operation is different, depending upon the individual condition and response of each patient. Nonetheless, your surgeon will be able to give you a good idea of what to expect.
The principle of informed consent is endorsed by the American College of Surgeons, the largest organization of surgeons in the world with more than 54,000 members. The Statements on Principles of the College says, in part, "Patients should understand the indications for the operation, the risk involved, and the result that it is hoped to attain."
Surgery by Surgeons
A fully trained surgeon is a physician who, after medical school, has gone through years of training in an accredited residency program to learn the specialized skills of a surgeon. One good sign of a surgeon's competence is certification by a national surgical board approved by the American Board of Medical Specialties. All board-certified surgeons have satisfactorily completed an approved residency training program and have passed a rigorous specialty examination.
The letters F.A.C.S. (Fellow of the American College of Surgeons) after a surgeon's name are a further indication of a physician's qualifications. Surgeons who become Fellows of the College have passed a comprehensive evaluation of their surgical training and skills; they also have demonstrated their commitment to high standards of ethical conduct. This evaluation is conducted according to national standards that were established to ensure that patients receive the best possible surgical care.
Prepared as a public service by the American College of Surgeons.
American College of SurgeonsOffice of Public Information 633 N. Saint Clair St.Chicago, IL 60611
If you are considering an operation, you may have further questions in these topic areas:
Who should do your operation?
Should you seek consultation?
What will your operation cost?
http://www.facs.org/public_info/operation/consent.html
This may appear to be a formality, but, in fact, this process should be taken very seriously. Before your operation, frankly discuss with your surgeon any questions or concerns that you have. Of course, not everyone wants to know all the specific details of the surgical procedure itself, but you should seek the answers to questions such as:
Questions
Principle of informed consent
Surgery by Surgeons
What are the indications that have led your doctor to the opinion that an operation is necessary?
What, if any, alternative treatments are available for your condition?
What will be the likely result if you don't have the operation?
What are the basic procedures involved in the operation?
What are the risks?
How is the operation expected to improve your health or quality of life?
Is hospitalization necessary and, if so, how long can you expect to be hospitalized?
What can you expect during your recovery period?
When can you expect to resume normal activities?
Are there likely to be residual effects from the operation?
Of course, your surgeon may volunteer much of this information. However, if you still have questions, don't hesitate to ask. Remember, the operation is being performed on you, and you should seek any information that you need to improve your understanding. Your doctor should be willing to take whatever time is necessary to make sure that you are fully informed. No doctor can, or should, guarantee outcomes, because each operation is different, depending upon the individual condition and response of each patient. Nonetheless, your surgeon will be able to give you a good idea of what to expect.
The principle of informed consent is endorsed by the American College of Surgeons, the largest organization of surgeons in the world with more than 54,000 members. The Statements on Principles of the College says, in part, "Patients should understand the indications for the operation, the risk involved, and the result that it is hoped to attain."
Surgery by Surgeons
A fully trained surgeon is a physician who, after medical school, has gone through years of training in an accredited residency program to learn the specialized skills of a surgeon. One good sign of a surgeon's competence is certification by a national surgical board approved by the American Board of Medical Specialties. All board-certified surgeons have satisfactorily completed an approved residency training program and have passed a rigorous specialty examination.
The letters F.A.C.S. (Fellow of the American College of Surgeons) after a surgeon's name are a further indication of a physician's qualifications. Surgeons who become Fellows of the College have passed a comprehensive evaluation of their surgical training and skills; they also have demonstrated their commitment to high standards of ethical conduct. This evaluation is conducted according to national standards that were established to ensure that patients receive the best possible surgical care.
Prepared as a public service by the American College of Surgeons.
American College of SurgeonsOffice of Public Information 633 N. Saint Clair St.Chicago, IL 60611
If you are considering an operation, you may have further questions in these topic areas:
Who should do your operation?
Should you seek consultation?
What will your operation cost?
http://www.facs.org/public_info/operation/consent.html
The effect of Bosentan on healing of colonic anastomosis
Ziya Cetinkaya , Kazim Esen , Ibrahim H Ozercan , Bilal Ustundag , Refik Ayten and Erhan Aygen World Journal of Emergency Surgery 2006, 1:37 doi:10.1186/1749-7922-1-37
Published
18 December 2006Abstract (provisional)
The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.
Background
Ischemia is the most important factor compromises wound healing in colonic anastomosis. Mesenteric vessels are ligated at first while performing colonic resection and following anastomosis. Therefore blood supply of the related segments of colon temporarily interrupted and ischemia can easily occur. This study was carried out to explore whether Bosentan, an endothelin-receptor antagonist, can eliminate vasoconstruction, increase blood flow in the splanchnic area and anastomotic region and therefore possibly facilitate wound healing and prevent intra-abdominal adhesion formation. Metods: Study is conducted on 30 female Wistar-Albino rats weighing 180-240 gr. Rats were allocated into three groups. Group 1 (n=10) recevied full-thickness resection of the left colon and end-to-end anastomosis. In Groups 2 (n=10) and 3 (n=10), vessels of 2-3 cm segment of the left colon were ligated, indications of necrosis of that segment were expected, followed by resection and end-to-end anastomosis. Two milliliter of saline and 5 mg/kg Bosentan was given intraperitoneally in Group 2 and 3, respectively. On postoperativ day 6, intra-abdominal adhesions were scored. Healing of anastomosis, anastomotic bursting pressures, tissue hydroxyproline levels and histopatologically healing scores were assessed.
Results
Macroscopic adhesion score in Group 3 was lower than the remained groups (p<0.05). Tissue hydroxyproline levels were significantly higher in Group 3 compared to the Groups 1 and 2 (p<0.001). Mean anastomotic bursting pressures were 200 mmHg, 164 mmHg and 240 mmHg in Groups 1, 2 an 3, respectively (p<0.05 between Groups 1 and 3; p<0.001 between Groups 2 and 3). Histopathologically, healing scores of Group 1 were significantly higher than the other groups (p<0.05 group 1-3, group 2-3).
Conclusions
Bosentan increases anastomotic healing of ischemic colonic anastomosis and decreases intra-abdominal adhesion formation.
http://www.wjes.org/content/1/1/37
Published
18 December 2006Abstract (provisional)
The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.
Background
Ischemia is the most important factor compromises wound healing in colonic anastomosis. Mesenteric vessels are ligated at first while performing colonic resection and following anastomosis. Therefore blood supply of the related segments of colon temporarily interrupted and ischemia can easily occur. This study was carried out to explore whether Bosentan, an endothelin-receptor antagonist, can eliminate vasoconstruction, increase blood flow in the splanchnic area and anastomotic region and therefore possibly facilitate wound healing and prevent intra-abdominal adhesion formation. Metods: Study is conducted on 30 female Wistar-Albino rats weighing 180-240 gr. Rats were allocated into three groups. Group 1 (n=10) recevied full-thickness resection of the left colon and end-to-end anastomosis. In Groups 2 (n=10) and 3 (n=10), vessels of 2-3 cm segment of the left colon were ligated, indications of necrosis of that segment were expected, followed by resection and end-to-end anastomosis. Two milliliter of saline and 5 mg/kg Bosentan was given intraperitoneally in Group 2 and 3, respectively. On postoperativ day 6, intra-abdominal adhesions were scored. Healing of anastomosis, anastomotic bursting pressures, tissue hydroxyproline levels and histopatologically healing scores were assessed.
Results
Macroscopic adhesion score in Group 3 was lower than the remained groups (p<0.05). Tissue hydroxyproline levels were significantly higher in Group 3 compared to the Groups 1 and 2 (p<0.001). Mean anastomotic bursting pressures were 200 mmHg, 164 mmHg and 240 mmHg in Groups 1, 2 an 3, respectively (p<0.05 between Groups 1 and 3; p<0.001 between Groups 2 and 3). Histopathologically, healing scores of Group 1 were significantly higher than the other groups (p<0.05 group 1-3, group 2-3).
Conclusions
Bosentan increases anastomotic healing of ischemic colonic anastomosis and decreases intra-abdominal adhesion formation.
http://www.wjes.org/content/1/1/37
Wednesday, December 27, 2006
Efficacy of Tricyclic Antidepressant is Associated with Beta2-Adrenoceptor Genotype in Patients with Interstitial Cystitis
Efficacy of Tricyclic Antidepressant is Associated with Beta2-Adrenoceptor Genotype in Patients with Interstitial CystitisWednesday, 27 December 2006BERKELEY, CA (UroToday.com) - Tricyclic antidepressant therapy (amitriptyline in particular) is effective in treating the symptoms of PBS/IC. These drugs block the active transport system that is involved in the re-uptake of serotonin and noradrenaline.read more
OMRIX Biopharmaceuticals Files Investigational New Drug (IND) Application For Anti-Adhesion Product
December 27, 2006 07:10 AM Eastern Time
OMRIX Biopharmaceuticals Files Investigational New Drug (IND) Application For Anti-Adhesion Product Candidate and Announces Recent Milestone Achievements
NEW YORK--(BUSINESS WIRE)--OMRIX Biopharmaceuticals, Inc. (“OMRIX” or the “Company”) (NASDAQ:OMRI), a commercial-stage biopharmaceutical company that develops and markets biosurgical and antibody-based products, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its Anti-Adhesion product candidate and achieved several milestones in the fourth quarter of 2006.
OMRIX’ Anti-Adhesion product candidate, Adhexil, is based on the Company’s fibrin sealant platform and is intended for use as a barrier substance to prevent post-operative adhesions. These adhesions have been shown to develop in up to 93% of patients following various surgical procedures, including pelvic, abdominal and cardiac surgery. Adhexil, once applied under minimally invasive procedures, forms a physical barrier preventing adhesions of the operated tissues. During the operation, the product is sprayed onto surfaces most at risk of forming adhesions. This coats and protects the tissues from post-operative adhesions. After the surgical wounds heal, the fibrin barrier is naturally absorbed.
Initially, OMRIX is targeting the laparoscopic gynecology market. Laparoscopic surgery is becoming more extensive and popular and the Company believes Adhexil’s competitive advantage is the product’s ability to be applied laparoscopically in the presence of bleeding. OMRIX intends to launch Adhexil in the EU and the U.S. in 2009.
“We are pleased to end 2006 with the filing of an IND for our anti-adhesion product and confirm the achievement of several milestones we previously stated would occur before year end,” stated Robert Taub, OMRIX’ President and Chief Executive Officer. “Adhexil is one example of how we are expanding our product pipeline beyond current indications and diversifying our distribution channels. We look forward to 2007 as we continue to rapidly advance our development pipeline and expand the market presence of our commercialized products.”
In addition, OMRIX achieved the following milestones in the fourth quarter of 2006: 1) Completed patient enrollment in the West Nile Virus (WNV) Phase
1/2 clinical trial. The clinical trial includes a three month
follow up.
2) Completed the high titer vaccinia immunoglobulin (HT-VIG)
preclinical studies.
3) Completed patient enrollment in the Evicel Phase 3 clinical
trial in kidney surgery, the last clinical trial needed to file
for a general hemostasis indication with the FDA.
About Adhexil
Adhexil is designed to be non-reactive but protective to tissue at adhesion risk during the critical wound healing period before being reabsorbed and cleared. It is designed to remain adherent to the target tissue and should be easily applied during laparoscopic procedures performed on adhesiogenic organs such as ovaries.
About WNIG
OMRIX’s West Nile Immunoglobulin, or WNIG, derived from human plasma, is intended to provide effective treatment to patients with or at high risk for progression to WNV encephalitis and/or myelitis. Currently, there are no licensed therapies available to treat WNV infection.
About HT-VIG
Based on pre clinical data, HT-VIG is a more potent form of OMRIX’s Vaccinia Immunoglobulin (VIG) product and is intended to be used in smaller volumes than existing VIG preparations for the same indication. The smaller volume of HT-VIG is designed for rapid deployment by medical personnel to treat more patients in urgent situations.
About Evicel
OMRIX is expending the indications for its second generation fibrin sealant, Evicel™, in collaboration with Ethicon, a Johnson & Johnson company. OMRIX is seeking to obtain approval for Evicel™ as an adjunct to hemostasis for general surgical use in the U.S. and the EU. Evicel is unique in its ease of use, immediate availability to the surgeon and its bovine-free formulation. It provides for important hemostasis support when conventional surgical techniques (i.e., suture, ligature, and cautery) prove to be inefficient, ineffective or impractical. The Phase 3 clinical trial in kidney surgery is the last of three clinical trials required from Omrix to file for a general hemostasis indication with the FDA. The anticipated FDA approval of a kidney indication will trigger the general hemostasis indication approval, which means that the Ethicon sales force will be able to market the product for use in any type of surgery where fibrin sealants are applicable for use.
About OMRIX Biopharmaceuticals, Inc.
OMRIX, a commercial-stage biopharmaceutical company, develops and markets innovative biosurgical and antibody-based products, utilizing its proprietary protein purification technology and manufacturing know-how. As part of its business strategy, OMRIX commercializes certain biosurgical products through collaborations with companies whose marketing and sales expertise are a complement to OMRIX's own areas of specialty. OMRIX' novel and easy-to-use Fibrin Patch, a biological-device convergence product candidate, addresses unmet medical needs. For more information, please visit: www.omrix.com.
Safe Harbor Statement
This press release contains forward-looking statements. Forward-looking statements provide the company's current expectations or forecasts of future events. Forward-looking statements include statements about the Company's expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. The company's actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the company’s filings with the SEC, including sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the company's registration statement as filed with the Securities and Exchange Commission on December 14, 2006 and the company’s most recent quarterly reports on Form 10-Q and its current reports on Form 8-K. Unless required by law, the company undertakes no obligation to publicly update or revise any forward-looking statement to reflect circumstances or events after the date of this press release.
http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20061227005036&newsLang=en
OMRIX Biopharmaceuticals Files Investigational New Drug (IND) Application For Anti-Adhesion Product Candidate and Announces Recent Milestone Achievements
NEW YORK--(BUSINESS WIRE)--OMRIX Biopharmaceuticals, Inc. (“OMRIX” or the “Company”) (NASDAQ:OMRI), a commercial-stage biopharmaceutical company that develops and markets biosurgical and antibody-based products, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its Anti-Adhesion product candidate and achieved several milestones in the fourth quarter of 2006.
OMRIX’ Anti-Adhesion product candidate, Adhexil, is based on the Company’s fibrin sealant platform and is intended for use as a barrier substance to prevent post-operative adhesions. These adhesions have been shown to develop in up to 93% of patients following various surgical procedures, including pelvic, abdominal and cardiac surgery. Adhexil, once applied under minimally invasive procedures, forms a physical barrier preventing adhesions of the operated tissues. During the operation, the product is sprayed onto surfaces most at risk of forming adhesions. This coats and protects the tissues from post-operative adhesions. After the surgical wounds heal, the fibrin barrier is naturally absorbed.
Initially, OMRIX is targeting the laparoscopic gynecology market. Laparoscopic surgery is becoming more extensive and popular and the Company believes Adhexil’s competitive advantage is the product’s ability to be applied laparoscopically in the presence of bleeding. OMRIX intends to launch Adhexil in the EU and the U.S. in 2009.
“We are pleased to end 2006 with the filing of an IND for our anti-adhesion product and confirm the achievement of several milestones we previously stated would occur before year end,” stated Robert Taub, OMRIX’ President and Chief Executive Officer. “Adhexil is one example of how we are expanding our product pipeline beyond current indications and diversifying our distribution channels. We look forward to 2007 as we continue to rapidly advance our development pipeline and expand the market presence of our commercialized products.”
In addition, OMRIX achieved the following milestones in the fourth quarter of 2006: 1) Completed patient enrollment in the West Nile Virus (WNV) Phase
1/2 clinical trial. The clinical trial includes a three month
follow up.
2) Completed the high titer vaccinia immunoglobulin (HT-VIG)
preclinical studies.
3) Completed patient enrollment in the Evicel Phase 3 clinical
trial in kidney surgery, the last clinical trial needed to file
for a general hemostasis indication with the FDA.
About Adhexil
Adhexil is designed to be non-reactive but protective to tissue at adhesion risk during the critical wound healing period before being reabsorbed and cleared. It is designed to remain adherent to the target tissue and should be easily applied during laparoscopic procedures performed on adhesiogenic organs such as ovaries.
About WNIG
OMRIX’s West Nile Immunoglobulin, or WNIG, derived from human plasma, is intended to provide effective treatment to patients with or at high risk for progression to WNV encephalitis and/or myelitis. Currently, there are no licensed therapies available to treat WNV infection.
About HT-VIG
Based on pre clinical data, HT-VIG is a more potent form of OMRIX’s Vaccinia Immunoglobulin (VIG) product and is intended to be used in smaller volumes than existing VIG preparations for the same indication. The smaller volume of HT-VIG is designed for rapid deployment by medical personnel to treat more patients in urgent situations.
About Evicel
OMRIX is expending the indications for its second generation fibrin sealant, Evicel™, in collaboration with Ethicon, a Johnson & Johnson company. OMRIX is seeking to obtain approval for Evicel™ as an adjunct to hemostasis for general surgical use in the U.S. and the EU. Evicel is unique in its ease of use, immediate availability to the surgeon and its bovine-free formulation. It provides for important hemostasis support when conventional surgical techniques (i.e., suture, ligature, and cautery) prove to be inefficient, ineffective or impractical. The Phase 3 clinical trial in kidney surgery is the last of three clinical trials required from Omrix to file for a general hemostasis indication with the FDA. The anticipated FDA approval of a kidney indication will trigger the general hemostasis indication approval, which means that the Ethicon sales force will be able to market the product for use in any type of surgery where fibrin sealants are applicable for use.
About OMRIX Biopharmaceuticals, Inc.
OMRIX, a commercial-stage biopharmaceutical company, develops and markets innovative biosurgical and antibody-based products, utilizing its proprietary protein purification technology and manufacturing know-how. As part of its business strategy, OMRIX commercializes certain biosurgical products through collaborations with companies whose marketing and sales expertise are a complement to OMRIX's own areas of specialty. OMRIX' novel and easy-to-use Fibrin Patch, a biological-device convergence product candidate, addresses unmet medical needs. For more information, please visit: www.omrix.com.
Safe Harbor Statement
This press release contains forward-looking statements. Forward-looking statements provide the company's current expectations or forecasts of future events. Forward-looking statements include statements about the Company's expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. The company's actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the company’s filings with the SEC, including sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the company's registration statement as filed with the Securities and Exchange Commission on December 14, 2006 and the company’s most recent quarterly reports on Form 10-Q and its current reports on Form 8-K. Unless required by law, the company undertakes no obligation to publicly update or revise any forward-looking statement to reflect circumstances or events after the date of this press release.
http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20061227005036&newsLang=en
ARDvark Blog Medical Headlines
Deadline For Medicare Prescription Drug Plan Days Away
If you want to change your Medical prescription drug plan, or join one for the first time, you are now just four days away from the deadline, 31st December, 2006. This time round many premiums have gone up in price, while several existing ones will not offer the same drug coverage...[read article]
Structure Of Iron Regulatory Protein-RNA Complex Solved
Experience Sculpts Brain Circuitry To Build Resiliency To Stress
Unbelted Backseat Passengers Produce Deadly Results
Genetic Mechanism Helps Explain Chronic Pain Disorders
Guidelines For Patients Seeking Cosmetic Procedures Abroad
Home Health-Care Workers Have Few Legal Protections, Law Professor Finds
Heartburn drugs are connected to the hip bones
Is 'brain training' slowing aging?
If you want to change your Medical prescription drug plan, or join one for the first time, you are now just four days away from the deadline, 31st December, 2006. This time round many premiums have gone up in price, while several existing ones will not offer the same drug coverage...[read article]
Structure Of Iron Regulatory Protein-RNA Complex Solved
Experience Sculpts Brain Circuitry To Build Resiliency To Stress
Unbelted Backseat Passengers Produce Deadly Results
Genetic Mechanism Helps Explain Chronic Pain Disorders
Guidelines For Patients Seeking Cosmetic Procedures Abroad
Home Health-Care Workers Have Few Legal Protections, Law Professor Finds
Heartburn drugs are connected to the hip bones
Is 'brain training' slowing aging?
Tuesday, December 26, 2006
ARDvark Blog Medical News
Atlanta Hawks & Thrashers Make A Proactive Play Against Staph
Relative Abundance Of Common Microbes Living In The Gut May Contribute To Obesity
Top Five Women’s Health Stories Of 2006 As Selected By The Society For Women's Health Research
Declining US Fertility Rates To Be Studied By Binghamton University Researcher
ScientificAmerican.com Reveals 10 Clinical Trials To Watch
Incontinence A Common Postnatal Problem
Today's Research -- Tomorrow's Health: Experimental Biology 2007 Meets In Washington, DC April 28-May 2
Pain Therapeutics Initiates Phase III Study With Oxytrex(TM)
TV Programs Score Poorly In Seatbelt/Helmet Use
Higher Levels Of Vitamin D In The Blood May Lower Risk Of Multiple Sclerosis
Health-Care Delivery Contributes To Racial Disparity In Colorectal Cancer
Inflammatory Bowel Disease Doubles Risk Of Pregnancy Complications
Johns Hopkins Researchers Seek To Equip The Operating Room Of The Future
'Dua Anti-Reflux Valve' Found To Improve Quality Of Life For Bile Duct/pancreatic Cancer Patients
Bald, Happy And Vulnerable: Bacteria AfterTreatments For Urinary Infections
Relative Abundance Of Common Microbes Living In The Gut May Contribute To Obesity
Top Five Women’s Health Stories Of 2006 As Selected By The Society For Women's Health Research
Declining US Fertility Rates To Be Studied By Binghamton University Researcher
ScientificAmerican.com Reveals 10 Clinical Trials To Watch
Incontinence A Common Postnatal Problem
Today's Research -- Tomorrow's Health: Experimental Biology 2007 Meets In Washington, DC April 28-May 2
Pain Therapeutics Initiates Phase III Study With Oxytrex(TM)
TV Programs Score Poorly In Seatbelt/Helmet Use
Higher Levels Of Vitamin D In The Blood May Lower Risk Of Multiple Sclerosis
Health-Care Delivery Contributes To Racial Disparity In Colorectal Cancer
Inflammatory Bowel Disease Doubles Risk Of Pregnancy Complications
Johns Hopkins Researchers Seek To Equip The Operating Room Of The Future
'Dua Anti-Reflux Valve' Found To Improve Quality Of Life For Bile Duct/pancreatic Cancer Patients
Bald, Happy And Vulnerable: Bacteria AfterTreatments For Urinary Infections
Critique on New Yorker article promoting 'Industrialized Childbirth
Copy of My Official Letter to the New Yorker
Ongoing Comments on THE SCORE – published 2006-10-09
Web Access to Original Article
I am a former labor and delivery room nurse, mother of three and a grandmother. While my ovaries are honorably retired, my daughters are still of childbearing age. My first grandson was a breech baby born by electively scheduled cesarean. My daughter’s recovery took nine miserable months. Three years later his younger brother was born spontaneously. Her recovery was night and day different.
I also am a professional midwife who provides care to healthy women. Our practice uses the science-based principles of physiological management. Our cesarean rate is under 4%. Physiological management of childbirth is preventative – that is, associated with the lowest rate of mortality and morbidity for both mothers and babies. Its methods are also protective of the mother’s pelvic floor. This model of normal birth care is both safe and cost-effective. It is the standard used worldwide by family practice physicians, midwives and obstetricians in countries with much better maternal-infant outcomes than the US.
The obstetrical package – the centerpiece of ‘industrialized’ childbirth glowingly described by Dr Gawande – is associated with high levels of drug and anesthetic use, episiotomy, instrumental delivery (associated w/ stress incontinence), cesarean surgery, reduced rates of breastfeedingand increased number and severity of complications. When applied routinely, as it is in the US, to healthy women with normal pregnancies (70%), it is the opposite of evidence-based care. The obstetrical package for a healthy population – including the casual use of cesarean -- is not healthier, safer, cheaper or better for society than physiologic birth.
Nonetheless the author of the THE SCORE, along with many in the obstetrical profession, is promoting the notion that routinely scheduled cesareans are somehow safer and better than normal birth. But the science is unequivocal – the liberal or elective use of c-section does NOT improve perinatal outcomes. In addition to immediate surgical problems for the mother, other serious complications of cesareans are displaced to future pregnancies [1,3,4,5]. The notion that increased levels of morbidity and mortality are justified in pursuit of safety is an oxymoron.
Without ever establishing proof of efficacy, Cesarean section has become the most commonly performed surgery in the US. In 2005 it was 29% of all births. In 2003, 1.2 million cesareans cost $14.6 billion. [2] Forty percent of all maternity care is paid for by state and federal Medicaid programs; the other 60% is billed to employer-sponsored health insurance. Like all business expenses, the added cost of elective cesarean is incorporated into the price of goods and services and then passed on to us. For example, automakers add $1500 for employee health insurance to the cost of every car manufactured in the US. If more births are by elective, unnecessary surgery, that cost will rise even more rapidly, making America ever less competitive in a global economy.
So when I read articles such as THE SCORE, I feel like Alice in Wonderland. I have fallen down a rabbit hole into a land where professionals engage in double-speak and investigative journalism has been replaced by faith-based reporting. In this war on women’s biology, truth is also a victim.
Decades of medical and surgical interventions (i.e., the obstetrical package) used routinely on all childbearing women has resulted in unnecessary morbidity in otherwise normal vaginal birth. According to the Listening to Mothers surveys by the Maternity Center Association of NYC, over 90% of low-risk healthy women have seven or more significant intervention in a normal hospital birth and 47% are exposed to one or more surgical procedures or instrumental delivery. [3b]
The lack of obstetrical support for normal biology, paired with the sequelae of serious interventions, makes dismal statistics for vaginal birth. As a result, C-section starts to look pretty good --- like it’s not that much more dangerous. Why not “have it your way”, especially since Cesarean surgery is convenient for obstetricians, profitable for hospitals and makes interesting copy for newspapers on a slow news day?
The answer lies in the research circulated by doctors for other doctors, which tells quite a different story. According to insider information easily available to obstetricians [2], the sequelae of cesarean surgery include a grim list of intra-operative and post-op complications. In addition there is a whole new category of delayed and downstream complications unique to post-cesarean reproduction, which result in a total of 33 Cesarean-related ‘route of delivery’ complications, compared to only 4 route-of-delivery risks for spontaneous vaginal birth. [3a]
According to a preponderance of scientific literature, cesarean delivery more than doubles the rate of maternal death when compared to normal vaginal birth. An excellent study just published in September 2006 (file attached) found a 3.5 fold increase in the deaths of healthy women who had elective cesareans performed before onset of labor [4]. Anesthesia, infection (3 times higher following cesarean), and fatal blood clots (9 times higher following cesarean) were the big killers – the same complications that accompany all forms of surgery.
In addition to increased fatalities, these adverse events can also result in serious disability or permanent neurological damage for the new mother. [1] Cesarean increases the incidence of intra-operative hemorrhage and blood transfusions, and has a 13 times greater emergency hysterectomy rate than vaginal delivery. Post-operative complications include prolonged surgical pain, diminished mobility, bowel obstruction and difficulty breastfeeding.
Should a cesarean mother want to have another baby, she faces a secondary infertility rate of 6%, and an increased rate of ectopic pregnancies and miscarriages. Mothers in post-cesarean pregnancies have higher rates of serious placental problems, including placenta previa (placenta over the cervix) and placenta accreta or percreta (implanted in or through the wall of the uterus). Placenta percreta requires a hysterectomy at delivery and carries a maternal mortality rate of 7 to 10 % -- even in the very best, most well-equipped hospitals, in an operating room full of the most experienced surgeons. In addition, the likelihood of placental anomalies rises with each subsequent pregnancy, making it the dangerous gift that keeps on giving. [1]
Additional risks to fetuses and newborns in post-cesarean pregnancies include increased fetal demise & stillbirth rates and, in subsequent births, mortality and morbidity due to uterine rupture. For the baby, being born by any cesarean, primary or repeat, increases the rate of operative lacerations, respiratory distress, admission to the NICU, exposure to serious iatrogenic complications such as infection and drug errors in the special care nursery, decreased breastfeeding and increased rates of asthma in childhood and as an adult. [1]
Then there is the huge economic drain on our health care system. Cesareans cost 2 to 4 times more than normal hospital births, a figure that doesn’t count surgical anesthesia, special care nursery charges or any of the delayed and downstream problems described above. The costs of infertility treatments are enormous, as is the expense of mandatory repeat cesareans -- mandatory because most OBs are no longer allowed by their malpractice carriers and/or their hospitals to perform VBACs (vaginal birth after cesarean).
Unfortunately, THE SCORE did nothing to advance our understanding of this complex topic or promote a truly science-based debate. As with claims of WMDs, an informed public should demand evidence before taking drastic actions with permanent and potentially-harmful consequences. The alternative is to institutionalize dangerous and expensive practices without any public oversight or proof of benefit.
A letter by a family practice physician published just this week (Nov 7th) in the Canadian Medical Association Journal entitled “Not Safer and Not Cheaper”, sums up how the scientific data was manipulated and describes the many egregious consequences, personal as well as economic:
“ … in their economic analysis, [they] looked only at immediate costs, thus vastly underestimating the real costs of elective cesarean for breech or any birth. Since most women will have more than one birth, the presence of a uterine scar will expose women to increases in placenta previa and placenta acreta,5 ectopic pregnancy,6 abruption,5 infertility,7 stillbirth8 and excess hospital readmissions because of the cesarean9 and adhesion-related intestinal obstruction.10 All of these costs have been ignored.
This analysis led to headlines in the popular press that cesarean births are both safer and cheaper. This lack of nuance fuels societal views that increasingly suggest that cesarean section is just another way of giving birth; in addition, it undermines the confidence of a generation of women who are coming to believe that they cannot give birth without massive technological assistance.”
CMAJ • November 7, 2006; 175 (10); Michael Klein, MD Centre for Community Child Health Research, BC Child and Family Research, Institute, Vancouver, BC http://www.cmaj.ca/cgi/content/full/175/10/1243-a
We are long overdue for a robust public discourse about the routine use of the infamous ‘obstetrical package’ on healthy women. As for the obstetrical profession’s official distain and disregard for the preventative and protective principles of physiological management, well, the facts are plentiful. Just follow the money.
Personally, I would encourage the New Yorker to provide equal time and a rematch over this very biased and misleading article. The future of normal birth hangs in the balance.
Faith Gibson, LM, CPMExec Director, American College of Community MidwivesPalo Alto, CA 94303
_________________________________________________________________
[1] Ob.Gyn.News – http://www.obgynnews.com/ --The Leading Independent Newspaper for the Obstetrician /Gynecologist (search back issue archive by date, topic or title)
Elective C-section Revisited; Dr. Elaine Waetjen; August 1, 2002
C-Section Linked to Stillbirth in Next Pregnancy, 05/15/03
Maternal Morbidity Rises Sharply with Repeat Cesareans, 03/15/05
Prior C-Section Assoc. with Worse Outcomes – ICU Admit, postpartum infection, 03/01/05
Study Shows Elective Cesarean Riskier than Vaginal Delivery, 05/01/04
Asthma Associated with Planned Cesarean, 05/14/03
Cesarean Birth Associated with Adult Asthma, 06/15/01;
Steep Rise Seen in “No [Medical] Risk Primary C-Sections, 01/01/05
Offering C-Section ‘On Demand’ Can Be Ethical: ACOG, 12/01/03
Cesarean Rate Portends Rise in Placenta Accreta, 03/01/01
Placental Invasion on the Increase – hike in C-Section may be responsible, 01/15/03Placenta Previa, C-Section History Up Accreta Risk, 09/15/01
[2] August 02, 2005 WASHINGTON (Reuters) The most common U.S. hospital procedure is the Caesarean section, with 1.2 million of the operations done each year, according to a government report. Caesarean sections cost $14.6 billion in total charges in 2003, the report from the Agency for Healthcare Research and Quality's Healthcare Cost and Utilization Project found. The report, which can be found on the Internet at http://www.hcup.ahrq.gov/, lists the other top five in-patient hospital procedures
[3a] "What Every Pregnant Woman Needs to Know about Cesarean Section", a systemic review of the scientific literature by the Maternity Care Association of NYC;[3b] Listening to Mothers Surveys (2002, 2004, 2006) @ http://www.maternitywise.org/ 281 Park Ave S New York, NY 10010 (212) 777-5000
[4] Postpartum Maternal Mortality and Cesarean Delivery; C. Deneux-Tharanux, MD et. Al; Obstetrics and Gynecology, Vol 108, No 3, September 2006 (file attached)
[5] A July 2003 report by the ACOG Task Force on Neonatal Encephalopathy & Cerebral PalsyInternet access to supportive documentation www.sciencebasedbirth.com/CEO%20SSB/Synopsis_CEO_mission_2004.htm#scientific%20Literature
posted by faith gibson at 1:18 PM
http://normal-birth.blogspot.com/2006/11/copy-of-my-official-letter-to-new_15.html
Ongoing Comments on THE SCORE – published 2006-10-09
Web Access to Original Article
I am a former labor and delivery room nurse, mother of three and a grandmother. While my ovaries are honorably retired, my daughters are still of childbearing age. My first grandson was a breech baby born by electively scheduled cesarean. My daughter’s recovery took nine miserable months. Three years later his younger brother was born spontaneously. Her recovery was night and day different.
I also am a professional midwife who provides care to healthy women. Our practice uses the science-based principles of physiological management. Our cesarean rate is under 4%. Physiological management of childbirth is preventative – that is, associated with the lowest rate of mortality and morbidity for both mothers and babies. Its methods are also protective of the mother’s pelvic floor. This model of normal birth care is both safe and cost-effective. It is the standard used worldwide by family practice physicians, midwives and obstetricians in countries with much better maternal-infant outcomes than the US.
The obstetrical package – the centerpiece of ‘industrialized’ childbirth glowingly described by Dr Gawande – is associated with high levels of drug and anesthetic use, episiotomy, instrumental delivery (associated w/ stress incontinence), cesarean surgery, reduced rates of breastfeedingand increased number and severity of complications. When applied routinely, as it is in the US, to healthy women with normal pregnancies (70%), it is the opposite of evidence-based care. The obstetrical package for a healthy population – including the casual use of cesarean -- is not healthier, safer, cheaper or better for society than physiologic birth.
Nonetheless the author of the THE SCORE, along with many in the obstetrical profession, is promoting the notion that routinely scheduled cesareans are somehow safer and better than normal birth. But the science is unequivocal – the liberal or elective use of c-section does NOT improve perinatal outcomes. In addition to immediate surgical problems for the mother, other serious complications of cesareans are displaced to future pregnancies [1,3,4,5]. The notion that increased levels of morbidity and mortality are justified in pursuit of safety is an oxymoron.
Without ever establishing proof of efficacy, Cesarean section has become the most commonly performed surgery in the US. In 2005 it was 29% of all births. In 2003, 1.2 million cesareans cost $14.6 billion. [2] Forty percent of all maternity care is paid for by state and federal Medicaid programs; the other 60% is billed to employer-sponsored health insurance. Like all business expenses, the added cost of elective cesarean is incorporated into the price of goods and services and then passed on to us. For example, automakers add $1500 for employee health insurance to the cost of every car manufactured in the US. If more births are by elective, unnecessary surgery, that cost will rise even more rapidly, making America ever less competitive in a global economy.
So when I read articles such as THE SCORE, I feel like Alice in Wonderland. I have fallen down a rabbit hole into a land where professionals engage in double-speak and investigative journalism has been replaced by faith-based reporting. In this war on women’s biology, truth is also a victim.
Decades of medical and surgical interventions (i.e., the obstetrical package) used routinely on all childbearing women has resulted in unnecessary morbidity in otherwise normal vaginal birth. According to the Listening to Mothers surveys by the Maternity Center Association of NYC, over 90% of low-risk healthy women have seven or more significant intervention in a normal hospital birth and 47% are exposed to one or more surgical procedures or instrumental delivery. [3b]
The lack of obstetrical support for normal biology, paired with the sequelae of serious interventions, makes dismal statistics for vaginal birth. As a result, C-section starts to look pretty good --- like it’s not that much more dangerous. Why not “have it your way”, especially since Cesarean surgery is convenient for obstetricians, profitable for hospitals and makes interesting copy for newspapers on a slow news day?
The answer lies in the research circulated by doctors for other doctors, which tells quite a different story. According to insider information easily available to obstetricians [2], the sequelae of cesarean surgery include a grim list of intra-operative and post-op complications. In addition there is a whole new category of delayed and downstream complications unique to post-cesarean reproduction, which result in a total of 33 Cesarean-related ‘route of delivery’ complications, compared to only 4 route-of-delivery risks for spontaneous vaginal birth. [3a]
According to a preponderance of scientific literature, cesarean delivery more than doubles the rate of maternal death when compared to normal vaginal birth. An excellent study just published in September 2006 (file attached) found a 3.5 fold increase in the deaths of healthy women who had elective cesareans performed before onset of labor [4]. Anesthesia, infection (3 times higher following cesarean), and fatal blood clots (9 times higher following cesarean) were the big killers – the same complications that accompany all forms of surgery.
In addition to increased fatalities, these adverse events can also result in serious disability or permanent neurological damage for the new mother. [1] Cesarean increases the incidence of intra-operative hemorrhage and blood transfusions, and has a 13 times greater emergency hysterectomy rate than vaginal delivery. Post-operative complications include prolonged surgical pain, diminished mobility, bowel obstruction and difficulty breastfeeding.
Should a cesarean mother want to have another baby, she faces a secondary infertility rate of 6%, and an increased rate of ectopic pregnancies and miscarriages. Mothers in post-cesarean pregnancies have higher rates of serious placental problems, including placenta previa (placenta over the cervix) and placenta accreta or percreta (implanted in or through the wall of the uterus). Placenta percreta requires a hysterectomy at delivery and carries a maternal mortality rate of 7 to 10 % -- even in the very best, most well-equipped hospitals, in an operating room full of the most experienced surgeons. In addition, the likelihood of placental anomalies rises with each subsequent pregnancy, making it the dangerous gift that keeps on giving. [1]
Additional risks to fetuses and newborns in post-cesarean pregnancies include increased fetal demise & stillbirth rates and, in subsequent births, mortality and morbidity due to uterine rupture. For the baby, being born by any cesarean, primary or repeat, increases the rate of operative lacerations, respiratory distress, admission to the NICU, exposure to serious iatrogenic complications such as infection and drug errors in the special care nursery, decreased breastfeeding and increased rates of asthma in childhood and as an adult. [1]
Then there is the huge economic drain on our health care system. Cesareans cost 2 to 4 times more than normal hospital births, a figure that doesn’t count surgical anesthesia, special care nursery charges or any of the delayed and downstream problems described above. The costs of infertility treatments are enormous, as is the expense of mandatory repeat cesareans -- mandatory because most OBs are no longer allowed by their malpractice carriers and/or their hospitals to perform VBACs (vaginal birth after cesarean).
Unfortunately, THE SCORE did nothing to advance our understanding of this complex topic or promote a truly science-based debate. As with claims of WMDs, an informed public should demand evidence before taking drastic actions with permanent and potentially-harmful consequences. The alternative is to institutionalize dangerous and expensive practices without any public oversight or proof of benefit.
A letter by a family practice physician published just this week (Nov 7th) in the Canadian Medical Association Journal entitled “Not Safer and Not Cheaper”, sums up how the scientific data was manipulated and describes the many egregious consequences, personal as well as economic:
“ … in their economic analysis, [they] looked only at immediate costs, thus vastly underestimating the real costs of elective cesarean for breech or any birth. Since most women will have more than one birth, the presence of a uterine scar will expose women to increases in placenta previa and placenta acreta,5 ectopic pregnancy,6 abruption,5 infertility,7 stillbirth8 and excess hospital readmissions because of the cesarean9 and adhesion-related intestinal obstruction.10 All of these costs have been ignored.
This analysis led to headlines in the popular press that cesarean births are both safer and cheaper. This lack of nuance fuels societal views that increasingly suggest that cesarean section is just another way of giving birth; in addition, it undermines the confidence of a generation of women who are coming to believe that they cannot give birth without massive technological assistance.”
CMAJ • November 7, 2006; 175 (10); Michael Klein, MD Centre for Community Child Health Research, BC Child and Family Research, Institute, Vancouver, BC http://www.cmaj.ca/cgi/content/full/175/10/1243-a
We are long overdue for a robust public discourse about the routine use of the infamous ‘obstetrical package’ on healthy women. As for the obstetrical profession’s official distain and disregard for the preventative and protective principles of physiological management, well, the facts are plentiful. Just follow the money.
Personally, I would encourage the New Yorker to provide equal time and a rematch over this very biased and misleading article. The future of normal birth hangs in the balance.
Faith Gibson, LM, CPMExec Director, American College of Community MidwivesPalo Alto, CA 94303
_________________________________________________________________
[1] Ob.Gyn.News – http://www.obgynnews.com/ --The Leading Independent Newspaper for the Obstetrician /Gynecologist (search back issue archive by date, topic or title)
Elective C-section Revisited; Dr. Elaine Waetjen; August 1, 2002
C-Section Linked to Stillbirth in Next Pregnancy, 05/15/03
Maternal Morbidity Rises Sharply with Repeat Cesareans, 03/15/05
Prior C-Section Assoc. with Worse Outcomes – ICU Admit, postpartum infection, 03/01/05
Study Shows Elective Cesarean Riskier than Vaginal Delivery, 05/01/04
Asthma Associated with Planned Cesarean, 05/14/03
Cesarean Birth Associated with Adult Asthma, 06/15/01;
Steep Rise Seen in “No [Medical] Risk Primary C-Sections, 01/01/05
Offering C-Section ‘On Demand’ Can Be Ethical: ACOG, 12/01/03
Cesarean Rate Portends Rise in Placenta Accreta, 03/01/01
Placental Invasion on the Increase – hike in C-Section may be responsible, 01/15/03Placenta Previa, C-Section History Up Accreta Risk, 09/15/01
[2] August 02, 2005 WASHINGTON (Reuters) The most common U.S. hospital procedure is the Caesarean section, with 1.2 million of the operations done each year, according to a government report. Caesarean sections cost $14.6 billion in total charges in 2003, the report from the Agency for Healthcare Research and Quality's Healthcare Cost and Utilization Project found. The report, which can be found on the Internet at http://www.hcup.ahrq.gov/, lists the other top five in-patient hospital procedures
[3a] "What Every Pregnant Woman Needs to Know about Cesarean Section", a systemic review of the scientific literature by the Maternity Care Association of NYC;[3b] Listening to Mothers Surveys (2002, 2004, 2006) @ http://www.maternitywise.org/ 281 Park Ave S New York, NY 10010 (212) 777-5000
[4] Postpartum Maternal Mortality and Cesarean Delivery; C. Deneux-Tharanux, MD et. Al; Obstetrics and Gynecology, Vol 108, No 3, September 2006 (file attached)
[5] A July 2003 report by the ACOG Task Force on Neonatal Encephalopathy & Cerebral PalsyInternet access to supportive documentation www.sciencebasedbirth.com/CEO%20SSB/Synopsis_CEO_mission_2004.htm#scientific%20Literature
posted by faith gibson at 1:18 PM
http://normal-birth.blogspot.com/2006/11/copy-of-my-official-letter-to-new_15.html
Life with Chronic Pain
by Sue Falkner Wood
A personal take on chronic pain
December 12, 2006
Chronic pain and an unexpected life
As I was addressing Christmas cards over the weekend, you know, the old-fashioned kind you send through the U.S. Mail? I browsed through my address book. Talk about a depressing experience. I guess the moral to that story is to change address books at least every two years - so many names of friends and family who are no longer alive. I discovered something else, however, when I read the names of those who are still around. I realized with each name there is a story. It isn’t a story about what they had planned for their lives. The stories are more about what they didn’t plan.
I have come to realize each of us face unexpected aspects of life. Many of them are wonderful, life-changing happenings that involve good fortune, life-long love and love one never imagined, such as becoming a parent. Other changes have to do with misfortune, loss, both personal and financial and loss of health or life due to some unforeseen disease or accident.
Each life in my address book was touched by some unexpected incident. One friend I just lost this year due to severe, long-lasting complications following a stomach stapling operation. She wanted to be thinner. One friend is still battling cancer. Another friend, who is like a brother to me, is struggling with ALS. The list goes on, painfully so, with lost parents, sisters, as well as friends. Three others have had to place their spouses in assisted living due to debilitating illness or Alzheimer’s. Many friends have had heartaches with their children, devastating auto accidents and other near cosmic events. This thing called life. It’s a risky business. Tomorrow is always a surprise. Plan as we may, we are not in charge. Always, the unexpected is there, lurking in the wings of our lives.
We don’t graduate from high school and autograph our yearbooks to friends with the salutation, “Good luck with your cancer.” “Sure hope you finally find true love after your two divorces.” “Hey, that’s really too bad you will never have children.” The future is filled with the unknown, the unplanned for and the unexpected, but here it comes anyway.
I have found some friends and family more prepared than others for life’s great variety. I often wonder what it is that separates us at times like that? Is it inner strength? Is it family fealty and devotion? Is it in the genes, or is it learned behavior? Is it a deep religious faith? Maybe some of us are just too ornery to give in and give up. My husband, Jim, tells me when I die I’m going to argue with St. Peter. That is, if I make it that far. I’m not sure what I’ll be arguing about. Accommodations? Wings? I know he was just trying to make a point. I get it.
My husband is the R.N. at our local county jail and works with people everyday who feel certain they have been dealt a bad hand in the poker game of life. Almost every one of them blames someone else for their fate. Someone else was responsible for starting them on drugs. They can’t get a break. The interesting thing is they don’t tell you what the problem really is, perhaps because they don’t know. Most of their problems started so far back, they can’t even remember. Problems passed on to them by parents who had problems with their parents. At other times, young people from good homes end up in the pokey because of bad choices they made along the way. They are often choices their parents had no knowledge of until it was, tragically, too late.
That seems to be the story. Batten down the hatches, gird your loins and all that other old-fashioned stuff because life is coming at you and one never knows what it will bring. I didn’t plan on giving up a career I loved as a nurse manager. I didn’t plan to have pain everyday of my life. One night, several years ago, I was crying and said to my husband, “I don’t think I can do this.” I felt so totally trapped by this disease and its many variables.
His reply was, “I don’t think you have a choice,” - direct, to the point and ultimately true. My husband is one of those unexpected events in my life that I am grateful for every day, well almost every day. It wouldn’t be honest of me to say our life is a romance novel because it isn’t. It’s totally real. Early in our relationship, I had to have abdominal surgery to remove some adhesions left from a somewhat violent tubal pregnancy that left things a mess “in there,” and had almost taken my life. I had to sign a consent form before the surgery in case I should need to have a colostomy - you know, that plastic bag that attaches on the outside of your body in case you can’t “go” the natural way. Although I was a nurse, I wasn’t prepared nor did I want to even think about that event. I asked Jim a typical woman’s question, “So, would you still love me if I have to have a colostomy?”
His reply was, “Well, sure. You’re not gonna spill it on me or anything, are you?” You see, that’s the kind of reality we live: me with my, oh, so many pain-filled problems. Jim with his “felons and fools.” Reality is a good thing. I like it most of the time as a coping mechanism. Denial doesn’t work too well for me because I’m always “slamming my head” against some physical problem or other. My life is unexpected but that’s not all bad. Many wonderful things have happened to me, too. With apologies to Clint Eastwood, I say, “The good, the bad and the ugly,” it’s all there. I don’t think if given the opportunity, I would trade places with anyone in my address book.
-Sue
http://blog.healthtalk.com/chronicpain/chronic-pain-and-an-unexpected-life
A personal take on chronic pain
December 12, 2006
Chronic pain and an unexpected life
As I was addressing Christmas cards over the weekend, you know, the old-fashioned kind you send through the U.S. Mail? I browsed through my address book. Talk about a depressing experience. I guess the moral to that story is to change address books at least every two years - so many names of friends and family who are no longer alive. I discovered something else, however, when I read the names of those who are still around. I realized with each name there is a story. It isn’t a story about what they had planned for their lives. The stories are more about what they didn’t plan.
I have come to realize each of us face unexpected aspects of life. Many of them are wonderful, life-changing happenings that involve good fortune, life-long love and love one never imagined, such as becoming a parent. Other changes have to do with misfortune, loss, both personal and financial and loss of health or life due to some unforeseen disease or accident.
Each life in my address book was touched by some unexpected incident. One friend I just lost this year due to severe, long-lasting complications following a stomach stapling operation. She wanted to be thinner. One friend is still battling cancer. Another friend, who is like a brother to me, is struggling with ALS. The list goes on, painfully so, with lost parents, sisters, as well as friends. Three others have had to place their spouses in assisted living due to debilitating illness or Alzheimer’s. Many friends have had heartaches with their children, devastating auto accidents and other near cosmic events. This thing called life. It’s a risky business. Tomorrow is always a surprise. Plan as we may, we are not in charge. Always, the unexpected is there, lurking in the wings of our lives.
We don’t graduate from high school and autograph our yearbooks to friends with the salutation, “Good luck with your cancer.” “Sure hope you finally find true love after your two divorces.” “Hey, that’s really too bad you will never have children.” The future is filled with the unknown, the unplanned for and the unexpected, but here it comes anyway.
I have found some friends and family more prepared than others for life’s great variety. I often wonder what it is that separates us at times like that? Is it inner strength? Is it family fealty and devotion? Is it in the genes, or is it learned behavior? Is it a deep religious faith? Maybe some of us are just too ornery to give in and give up. My husband, Jim, tells me when I die I’m going to argue with St. Peter. That is, if I make it that far. I’m not sure what I’ll be arguing about. Accommodations? Wings? I know he was just trying to make a point. I get it.
My husband is the R.N. at our local county jail and works with people everyday who feel certain they have been dealt a bad hand in the poker game of life. Almost every one of them blames someone else for their fate. Someone else was responsible for starting them on drugs. They can’t get a break. The interesting thing is they don’t tell you what the problem really is, perhaps because they don’t know. Most of their problems started so far back, they can’t even remember. Problems passed on to them by parents who had problems with their parents. At other times, young people from good homes end up in the pokey because of bad choices they made along the way. They are often choices their parents had no knowledge of until it was, tragically, too late.
That seems to be the story. Batten down the hatches, gird your loins and all that other old-fashioned stuff because life is coming at you and one never knows what it will bring. I didn’t plan on giving up a career I loved as a nurse manager. I didn’t plan to have pain everyday of my life. One night, several years ago, I was crying and said to my husband, “I don’t think I can do this.” I felt so totally trapped by this disease and its many variables.
His reply was, “I don’t think you have a choice,” - direct, to the point and ultimately true. My husband is one of those unexpected events in my life that I am grateful for every day, well almost every day. It wouldn’t be honest of me to say our life is a romance novel because it isn’t. It’s totally real. Early in our relationship, I had to have abdominal surgery to remove some adhesions left from a somewhat violent tubal pregnancy that left things a mess “in there,” and had almost taken my life. I had to sign a consent form before the surgery in case I should need to have a colostomy - you know, that plastic bag that attaches on the outside of your body in case you can’t “go” the natural way. Although I was a nurse, I wasn’t prepared nor did I want to even think about that event. I asked Jim a typical woman’s question, “So, would you still love me if I have to have a colostomy?”
His reply was, “Well, sure. You’re not gonna spill it on me or anything, are you?” You see, that’s the kind of reality we live: me with my, oh, so many pain-filled problems. Jim with his “felons and fools.” Reality is a good thing. I like it most of the time as a coping mechanism. Denial doesn’t work too well for me because I’m always “slamming my head” against some physical problem or other. My life is unexpected but that’s not all bad. Many wonderful things have happened to me, too. With apologies to Clint Eastwood, I say, “The good, the bad and the ugly,” it’s all there. I don’t think if given the opportunity, I would trade places with anyone in my address book.
-Sue
http://blog.healthtalk.com/chronicpain/chronic-pain-and-an-unexpected-life
Wednesday, December 20, 2006
Happy Holidays
Happy ( insert celebration Here)
form all our bloggers!
Wishing all a renewed sence of hope and faith for the new year
Tuesday, December 19, 2006
ARDvark Blog Medical Headlines
Alliance Pharmaceutical Corp. Clinical Study Approved To Start In France
Alliance Pharmaceutical Corp. (OTC Bulletin Board: ALLP) today announces the approval from the French Competent Authority to allow the start of the Phase 2 clinical trial for Oxygent(TM) (perfluorochemical [PFC] emulsion) to prevent post-op ileus resulting from hypoxia during major surgery.
Democratic, Republican Lawmakers Prepare Proposals That Would Expand State SCHIP Programs In 2007
Cadence Pharmaceuticals Initiates Pivotal Phase III Clinical Trial Evaluating Intravenous Acetaminophen For Post-Operative Acute Pain
Perrigo Announces Issue Of Approvable Letter By FDA For Dexcel's OTC Omeprazole
ZymoGenetics Submits Biologics License Application To The FDA For RhThrombin As An Aid To Controlling Bleeding During Surgery
Outbreak Of PVL-positive Community-associated MRSA, UK
Incoming House Speaker Pelosi Said Democrats Will Push Legislation That Would Mandate Government Price Negotiations For Medicare Prescription Drugs
Number Of Direct-to-Consumer Prescription Drug Advertisements Reviewed By FDA Has Decreased, GAO Report Finds
Sen. Wyden To Propose Plan That Would Provide Universal Health Care Coverage To All U.S. Residents Without Increasing Costs
Institute For Healthcare Improvement Releases Guidelines To Prevent Five Million Injuries In Hospitals
88 Percent Sensitivity For Colon Cancer Reported Using Non-Invasive Screening Test
Wrongful-Death Lawsuit Filed Against Ortho Evra Manufacturer Ortho-McNeil
Holiday Health/Safety Tips
Got The Holiday Blues? Mental Health Expert Offers Tips For A Happier Holiday Season
Alliance Pharmaceutical Corp. (OTC Bulletin Board: ALLP) today announces the approval from the French Competent Authority to allow the start of the Phase 2 clinical trial for Oxygent(TM) (perfluorochemical [PFC] emulsion) to prevent post-op ileus resulting from hypoxia during major surgery.
Democratic, Republican Lawmakers Prepare Proposals That Would Expand State SCHIP Programs In 2007
Cadence Pharmaceuticals Initiates Pivotal Phase III Clinical Trial Evaluating Intravenous Acetaminophen For Post-Operative Acute Pain
Perrigo Announces Issue Of Approvable Letter By FDA For Dexcel's OTC Omeprazole
ZymoGenetics Submits Biologics License Application To The FDA For RhThrombin As An Aid To Controlling Bleeding During Surgery
Outbreak Of PVL-positive Community-associated MRSA, UK
Incoming House Speaker Pelosi Said Democrats Will Push Legislation That Would Mandate Government Price Negotiations For Medicare Prescription Drugs
Number Of Direct-to-Consumer Prescription Drug Advertisements Reviewed By FDA Has Decreased, GAO Report Finds
Sen. Wyden To Propose Plan That Would Provide Universal Health Care Coverage To All U.S. Residents Without Increasing Costs
Institute For Healthcare Improvement Releases Guidelines To Prevent Five Million Injuries In Hospitals
88 Percent Sensitivity For Colon Cancer Reported Using Non-Invasive Screening Test
Wrongful-Death Lawsuit Filed Against Ortho Evra Manufacturer Ortho-McNeil
Holiday Health/Safety Tips
Got The Holiday Blues? Mental Health Expert Offers Tips For A Happier Holiday Season
Arachnoiditis - Life After Depo-Medrol - Sheer Hopeless Hell
March 10, 2006by Evelyn Pringle
http://www.opednews.com
Complaining of a sudden localized hip pain, in January 2002, Dennis Capolongo, was diagnosed with a disc herniation and given 2 epidural injections of the steroid Depo-Medrol that resulted in two trips to the ER, a stint in the hospital, and horrific back pain that continued nonstop for months.
A short time later, when reviewing his original MRIs, new doctors found nothing to substantiate the disc herniation diagnosis or the need for Depo-Medrol. It is now believed the hip pain Dennis experienced was caused by a sprain and not from any back problem.
However, he now is forced to live with arachnoiditis caused by epidural steroid injections (ESIs). "Arachnoiditis describes a pain disorder caused by the inflammation of the arachnoid, one of the membranes that surround and protect the nerves of the spinal cord," according Dr Robert Filice, MD in Depo-Medrol: Another Good Reason to Choose Prolotherapy.
The inflammation sometimes leads to the formation of scar tissue and adhesions, which cause the spinal nerves to "stick" together at which point arachnoiditis begins to interfere with the function of the nerves, causing symptoms such as numbness, tingling, and a characteristic stinging and burning pain in the lower back or legs, according to Dr Filice.
There is no cure for arachnoiditis and treatment options are limited to pain relief similar to treatments for other chronic pain conditions.
Dennis has organized the "End Depo Now Campaign" (EDNC), a grassroots advocacy group seeking to have Depo-Medrol banned from epidural use. Research by EDNC has determined:
(1) there are only two natural ways to contract the condition. One is through trauma to the spinal cord; the other is through contamination of the Cerebro Spinal Fluid (CSF) by foreign bodies such as bacteria and viruses, which cross the blood brain barrier.
(2) there are only two ways to contract the condition through medical procedures. One is through surgery, the equivalent of natural trauma, that can include blood contamination of the CFS; the other is through injecting foreign substances into the CFS, which causes the body to react in exactly the same way as it would to bacteria and viruses.
An ESI is a dangerous procedure. "When administering epidural injections, it is critical to recognize the risks associated with the introduction of potentially neurotoxic substances into the subarachnoid space, from which 40% of spinal fluid is produced," according to Milestone Scientific in a March 6, 2006 press release.
The only possible way Dennis could have contracted arachnoiditis is through the improper ESI because had no back problems. "I am living proof that a perfectly healthy person will suffer a spinal cord injury when subjected to this treatment," he says.
In the March 1999 paper, Adhesive Arachnoiditis Syndrome, Dr Sarah Smith summarizes the complexities and progression of the of disorder.
In the first stage, the spinal nerves are swollen and the adjacent blood vessels distended and the subarachnoid space disappears.
During the second stage, the scar tissue increases, and the nerves become adherent to each other and the dura.
In the third stage, adhesive arachnoiditis, involves complete encapsulation of the nerve roots and the scarring prevents the arachnoid from producing spinal fluid in that area.
Depo is the principal cause of arachnoiditis in the US. Dr Charles Burton maintains that almost all cases of clinically significant adhesive arachnoiditis are caused by Depo-Medrol.
Dr Burton is an expert in the treatment of complex spinal problems and has become a well-known advocate for arachnoiditis sufferers by promoting public awareness of the condition. His publication of the Burton Report in 2000 has raised awareness world-wide.
Depo victims must endure a lifetime of agony with a disability that affects every aspect day-to-day living. Arachnoiditis patient Zana G. describes her life as "sheer hopeless hell."
The condition, Zana says has "decimated my personal and professional lives, eradicated my hobbies, killed my love life, laid waste to my ability to travel and vacation with family and friends, made me a prisoner to my house, and my bed, driven my friends and family away."
"We have no cures, no treatments, no research into this condition, whatsoever," she says.
A major complaint heard from many victims is that ESIs are being administered off-label for conditions not approved by the FDA, without the patient's knowledge of their unapproved status.
The dangers associated with this off-label procedure has even prompted Pfizer, the maker of Depo, to post a warning on its web site against epidural use which states in part:
DEPO-MEDROL Sterile Aqueous Suspension is contraindicated for intrathecal administration. This formulation of methylprednisolone acetate has been associated with reports of severe medical events when administered by this route.
The Pfizer site also lists adverse reactions reported with the epidural administration as:
Arachnoiditis Bowel/bladder dysfunction Meningitis Headache Paraparesis/paraplegia Seizures Sensory disturbances
These warnings are nothing new. As far back as 1981, Upjohn, the Depro manufacturer at the time, stated "we would advise against the epidural/extradural routes of administration because of possible adverse reactions".
These warnings are rarely discussed with patients which means they have no opportunity to make an informed decision about whether or not to undergo the procedure after assessing the risk/benefit of the injections.
Advocacy groups say patients should always be advised when a drug is not approved. "Consumers should be told when they are receiving a drug for off-label use and make an informed decision if they want to accept the risk," according to pharmacist Larry Sasich, of the consumer watchdog group Public Citizen.
Dennis says patients will not be given this information unless they specifically ask for it. "Even then," he says, "there is no guarantee that their doctor will even know this latest update."
Therefore, a main goal of EDNC, he says, "is to have the FDA reevaluate the efficacy and safety of this steroid when used "off label" for epidural injections with the hope that they will label the steroid as contraindicated for epidural administration."
The fact is, there is no proof that Depo provides any benefit. According to the Injectable Corticosteroid Suspensions, 28 February 2006, Products—description, by the American Society of Health-System Pharmacists: "Currently, no clinical evidence conclusively shows that epidural corticosteroid injections are either effective or ineffective for relieving low back pain."
"Limited clinical data are available on the epidural route of administration," the group explains, "and use of the product for this indication is not included in the labeling."
"In addition," Pharmacists warns, "some preparations contain benzyl alcohol, a preservative that is not suitable for epidural injection," citing Glucocorticoids In: Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons; 2000:320-332.
By using the Freedom of Information Act, Dennis discovered that over 350 deaths and over 15,570 severe neurological events were reported to the FDA between 1998 and 2002 on person who received Depo.
In addition, EDNC conducted a survey and found hundreds of patients who complained of serious side effects following the off-label administration of steroid compounds where doctors refused to notify the FDA or the manufacturer through the MedWatch reporting system.
According to a Harvard study, less than 2% of adverse events are reported to the FDA. which means there must be hundreds of thousands of unsuspecting victim that have been injured by the improper use of Depo.
Dr Burton claims there is remarkable amount of ignorance in the medical field regarding ESIs. "Many physicians performing epidural steroid injections on a regular basis," he says, "do not even understand the relationship of this procedure to the possibility of creating adhesive arachnoiditis months later."
This ignorance is inexcusable because studies on the administration of ESIs have been discussed in medical journals for years. In 1999, neuroradiologists from the Center for Diagnostic Imaging in Minneapolis, surveyed 5,334 procedures performed and identified adhesive arachnoiditis as a "well described" potential complication.
The authors of the study stated: "The blind interlaminar technique introduces the potential for erroneous needle placement and subsequent injection of substances into undesired locations, such as the subarachnoid space".
The authors noted that blind needle injection, even by "skilled and experienced procedurists" has been found to be inaccurate in 25-30% of cases, in an article published in the April 1999 issue of the American Journal of Neuroradiol, 20:697-705.
Dr Burton says anestesiologists are the worst offenders when it comes to improper ESIs and statistics verify that claim. The American Association of Anesthesiologists Closed Claims Project / Journal Anesthesiology 2004; 100:98-105, listed ESI complications as accounting for 40% of all AAA malpractice closed-claims between 1970 & 1999.
A section of the Burton reports explains why the majority of lawsuits involve anesthesiologists. Because pain management is big business, anesthesiologists want to be involved in direct patient care, but training in spine care or pain management is typically not a part of their training.
Because reimbursement for administering ESIs is relatively high, Dr Burton says pain management centers have become "procedure mills."
But anesthesiologists are not familiar with adhesive arachnoiditis and the potential for toxicity of steroid suspensions upon entry of the subarachnoid space and mistakenly believe the "blind" needle approach to the space is accurate because they are not trained in the use of x-ray monitoring equipment and so they tend not to use it.
Lastly, an anesthesiologist rarely sees a patient after the procedure to provide them with direct information regarding a patient's progress.
When it comes to ESIs, Dr Burton says many medical professionals seem to be afflicted with the "New Guinea Syndrome," which is identified by the following comparison:
"As remarkable as it seems there are actually primitive tribes in existence today who have not yet connected the act of sexual intercourse with the birth of a child nine months later."
And:
"As remarkable as it seems there are also physicians providing drugs and therapies that have risk to patients who have not yet connected these risks to the serious complications routinely occurring months or years, afterwards."
However by now, the "New Guinea Syndrome" provides no defense for negligent doctors. "Ignorance of consequences," Dr Burton says, "is not an excuse when the medical and scientific community have clearly identified the patient risks."
"The only sensible approach at this point in time," he advises, "is to require medical professionals to fully explain the procedure and other options before it is carried out."
Dennis takes the issue a step further. In September 2004, he told a committee at the Institute of Medicine: "We need to stop the procedure that's causing more harm than good."
More information for injured parties can be found at Lawyers and Settlements.com
http://www.lawyersandsettlements.com/articles/depomedrol.html
By Evelyn Pringleevelyn.pringle@sbcglobal.net
http://www.opednews.com/articles/genera_evelyn_p_060310_life_after_depo_medr.htm
http://www.opednews.com
Complaining of a sudden localized hip pain, in January 2002, Dennis Capolongo, was diagnosed with a disc herniation and given 2 epidural injections of the steroid Depo-Medrol that resulted in two trips to the ER, a stint in the hospital, and horrific back pain that continued nonstop for months.
A short time later, when reviewing his original MRIs, new doctors found nothing to substantiate the disc herniation diagnosis or the need for Depo-Medrol. It is now believed the hip pain Dennis experienced was caused by a sprain and not from any back problem.
However, he now is forced to live with arachnoiditis caused by epidural steroid injections (ESIs). "Arachnoiditis describes a pain disorder caused by the inflammation of the arachnoid, one of the membranes that surround and protect the nerves of the spinal cord," according Dr Robert Filice, MD in Depo-Medrol: Another Good Reason to Choose Prolotherapy.
The inflammation sometimes leads to the formation of scar tissue and adhesions, which cause the spinal nerves to "stick" together at which point arachnoiditis begins to interfere with the function of the nerves, causing symptoms such as numbness, tingling, and a characteristic stinging and burning pain in the lower back or legs, according to Dr Filice.
There is no cure for arachnoiditis and treatment options are limited to pain relief similar to treatments for other chronic pain conditions.
Dennis has organized the "End Depo Now Campaign" (EDNC), a grassroots advocacy group seeking to have Depo-Medrol banned from epidural use. Research by EDNC has determined:
(1) there are only two natural ways to contract the condition. One is through trauma to the spinal cord; the other is through contamination of the Cerebro Spinal Fluid (CSF) by foreign bodies such as bacteria and viruses, which cross the blood brain barrier.
(2) there are only two ways to contract the condition through medical procedures. One is through surgery, the equivalent of natural trauma, that can include blood contamination of the CFS; the other is through injecting foreign substances into the CFS, which causes the body to react in exactly the same way as it would to bacteria and viruses.
An ESI is a dangerous procedure. "When administering epidural injections, it is critical to recognize the risks associated with the introduction of potentially neurotoxic substances into the subarachnoid space, from which 40% of spinal fluid is produced," according to Milestone Scientific in a March 6, 2006 press release.
The only possible way Dennis could have contracted arachnoiditis is through the improper ESI because had no back problems. "I am living proof that a perfectly healthy person will suffer a spinal cord injury when subjected to this treatment," he says.
In the March 1999 paper, Adhesive Arachnoiditis Syndrome, Dr Sarah Smith summarizes the complexities and progression of the of disorder.
In the first stage, the spinal nerves are swollen and the adjacent blood vessels distended and the subarachnoid space disappears.
During the second stage, the scar tissue increases, and the nerves become adherent to each other and the dura.
In the third stage, adhesive arachnoiditis, involves complete encapsulation of the nerve roots and the scarring prevents the arachnoid from producing spinal fluid in that area.
Depo is the principal cause of arachnoiditis in the US. Dr Charles Burton maintains that almost all cases of clinically significant adhesive arachnoiditis are caused by Depo-Medrol.
Dr Burton is an expert in the treatment of complex spinal problems and has become a well-known advocate for arachnoiditis sufferers by promoting public awareness of the condition. His publication of the Burton Report in 2000 has raised awareness world-wide.
Depo victims must endure a lifetime of agony with a disability that affects every aspect day-to-day living. Arachnoiditis patient Zana G. describes her life as "sheer hopeless hell."
The condition, Zana says has "decimated my personal and professional lives, eradicated my hobbies, killed my love life, laid waste to my ability to travel and vacation with family and friends, made me a prisoner to my house, and my bed, driven my friends and family away."
"We have no cures, no treatments, no research into this condition, whatsoever," she says.
A major complaint heard from many victims is that ESIs are being administered off-label for conditions not approved by the FDA, without the patient's knowledge of their unapproved status.
The dangers associated with this off-label procedure has even prompted Pfizer, the maker of Depo, to post a warning on its web site against epidural use which states in part:
DEPO-MEDROL Sterile Aqueous Suspension is contraindicated for intrathecal administration. This formulation of methylprednisolone acetate has been associated with reports of severe medical events when administered by this route.
The Pfizer site also lists adverse reactions reported with the epidural administration as:
Arachnoiditis Bowel/bladder dysfunction Meningitis Headache Paraparesis/paraplegia Seizures Sensory disturbances
These warnings are nothing new. As far back as 1981, Upjohn, the Depro manufacturer at the time, stated "we would advise against the epidural/extradural routes of administration because of possible adverse reactions".
These warnings are rarely discussed with patients which means they have no opportunity to make an informed decision about whether or not to undergo the procedure after assessing the risk/benefit of the injections.
Advocacy groups say patients should always be advised when a drug is not approved. "Consumers should be told when they are receiving a drug for off-label use and make an informed decision if they want to accept the risk," according to pharmacist Larry Sasich, of the consumer watchdog group Public Citizen.
Dennis says patients will not be given this information unless they specifically ask for it. "Even then," he says, "there is no guarantee that their doctor will even know this latest update."
Therefore, a main goal of EDNC, he says, "is to have the FDA reevaluate the efficacy and safety of this steroid when used "off label" for epidural injections with the hope that they will label the steroid as contraindicated for epidural administration."
The fact is, there is no proof that Depo provides any benefit. According to the Injectable Corticosteroid Suspensions, 28 February 2006, Products—description, by the American Society of Health-System Pharmacists: "Currently, no clinical evidence conclusively shows that epidural corticosteroid injections are either effective or ineffective for relieving low back pain."
"Limited clinical data are available on the epidural route of administration," the group explains, "and use of the product for this indication is not included in the labeling."
"In addition," Pharmacists warns, "some preparations contain benzyl alcohol, a preservative that is not suitable for epidural injection," citing Glucocorticoids In: Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons; 2000:320-332.
By using the Freedom of Information Act, Dennis discovered that over 350 deaths and over 15,570 severe neurological events were reported to the FDA between 1998 and 2002 on person who received Depo.
In addition, EDNC conducted a survey and found hundreds of patients who complained of serious side effects following the off-label administration of steroid compounds where doctors refused to notify the FDA or the manufacturer through the MedWatch reporting system.
According to a Harvard study, less than 2% of adverse events are reported to the FDA. which means there must be hundreds of thousands of unsuspecting victim that have been injured by the improper use of Depo.
Dr Burton claims there is remarkable amount of ignorance in the medical field regarding ESIs. "Many physicians performing epidural steroid injections on a regular basis," he says, "do not even understand the relationship of this procedure to the possibility of creating adhesive arachnoiditis months later."
This ignorance is inexcusable because studies on the administration of ESIs have been discussed in medical journals for years. In 1999, neuroradiologists from the Center for Diagnostic Imaging in Minneapolis, surveyed 5,334 procedures performed and identified adhesive arachnoiditis as a "well described" potential complication.
The authors of the study stated: "The blind interlaminar technique introduces the potential for erroneous needle placement and subsequent injection of substances into undesired locations, such as the subarachnoid space".
The authors noted that blind needle injection, even by "skilled and experienced procedurists" has been found to be inaccurate in 25-30% of cases, in an article published in the April 1999 issue of the American Journal of Neuroradiol, 20:697-705.
Dr Burton says anestesiologists are the worst offenders when it comes to improper ESIs and statistics verify that claim. The American Association of Anesthesiologists Closed Claims Project / Journal Anesthesiology 2004; 100:98-105, listed ESI complications as accounting for 40% of all AAA malpractice closed-claims between 1970 & 1999.
A section of the Burton reports explains why the majority of lawsuits involve anesthesiologists. Because pain management is big business, anesthesiologists want to be involved in direct patient care, but training in spine care or pain management is typically not a part of their training.
Because reimbursement for administering ESIs is relatively high, Dr Burton says pain management centers have become "procedure mills."
But anesthesiologists are not familiar with adhesive arachnoiditis and the potential for toxicity of steroid suspensions upon entry of the subarachnoid space and mistakenly believe the "blind" needle approach to the space is accurate because they are not trained in the use of x-ray monitoring equipment and so they tend not to use it.
Lastly, an anesthesiologist rarely sees a patient after the procedure to provide them with direct information regarding a patient's progress.
When it comes to ESIs, Dr Burton says many medical professionals seem to be afflicted with the "New Guinea Syndrome," which is identified by the following comparison:
"As remarkable as it seems there are actually primitive tribes in existence today who have not yet connected the act of sexual intercourse with the birth of a child nine months later."
And:
"As remarkable as it seems there are also physicians providing drugs and therapies that have risk to patients who have not yet connected these risks to the serious complications routinely occurring months or years, afterwards."
However by now, the "New Guinea Syndrome" provides no defense for negligent doctors. "Ignorance of consequences," Dr Burton says, "is not an excuse when the medical and scientific community have clearly identified the patient risks."
"The only sensible approach at this point in time," he advises, "is to require medical professionals to fully explain the procedure and other options before it is carried out."
Dennis takes the issue a step further. In September 2004, he told a committee at the Institute of Medicine: "We need to stop the procedure that's causing more harm than good."
More information for injured parties can be found at Lawyers and Settlements.com
http://www.lawyersandsettlements.com/articles/depomedrol.html
By Evelyn Pringleevelyn.pringle@sbcglobal.net
http://www.opednews.com/articles/genera_evelyn_p_060310_life_after_depo_medr.htm
Abdominal Pain and Cancer
Some types of abdominal problems accompany cancer and can include: abdominal pain, abdominal cramping, flatulence (gas)
ABDOMINAL PAIN/CRAMPING
What is abdominal pain and abdominal cramping? What is their relationship to cancer and chemotherapy treatments?
The abdomen is the part of the body located between the chest and the pelvis. Most people refer to it loosely at the stomach (although the stomach is an organ within the abdomen). Pain is a personal experience of discomfort. Abdominal pain can be associated with a variety of conditions both within and outside or the abdomen. Abdominal or lower abdominal pain can be a dull ache, cramping, or sharp pain. Dull aches and cramping are not uncommonly associated with some chemotherapy drugs. Sharp pain that does not resolve in a few minutes may be an indicator of a more serious problem.
Cancer treatment-induced abdominal pain, cramping and flatulence (gas):
Chemotherapy can cause both increased (rapid) and decreased (slow) motility of the intestines. In other words, the normal wave-like action that moves stool through the bowel may be faster or slower than usual.
Rapid motility may cause stool to travel faster and be less formed. Rapid motility can be associated with cramping and/or diarrhea.
Slow motility may cause stool to travel slower, becoming harder and dryer and more difficult to pass. It may contribute to constipation. Pain may be achy or cramp-like and may be associated with increased flatulence (gas).
Chemotherapy may also alter the normal bacterial flora that is present in the intestines. This can affect digestion and cause abdominal pain, cramping or flatulence (gas).
Steroids and other immunosuppressive medications may increase the probability of ulcers or other potentially serious abdominal complications such as perforation.
A history of or the development of lactose intolerance may contribute to worsening abdominal pain, cramping or flatulence (gas).
Cramping is a caused by a spasm (or contraction) of the bowel. It may be associated with the urge to move your bowels. It is not usually constant but comes more in "waves". It may be accompanied by either diarrhea, constipation or flatulence (gas).
Things you can do to manage abdominal pain or cramping:
In order for your health care provider to assist you in managing your pain, it is helpful for you to be able to adequately describe your pain. One way to do this is by answering the following questions.
You may choose to keep a diary so that you can track your pain over time:
Onset - when did the pain start? What was I doing when I had pain?
Quality - what does the pain feel like? Is it knifelike and stabbing, or dull and constant?
Location - Where is the pain? Can I point to it with my finger, or is it spread all over?
Intensity - How bad is your abdominal pain all the time? How bad is it with certain activities that cause you to feel pain, on a 1-10 scale, with the number "10" being the worst pain imaginable?
Duration - How long did the pain last for? Is it while I was walking to the door, or did it continue for a while?
Character or aggravating factors - Does the pain come and go whenever I perform a certain activity, or is it unpredictable?
Relieving factors - What can I do to make the abdominal pain go away? Does anything help? What have I used in the past that have worked, and does this work now?
How is your mood? Are you depressed or anxious? Does this make the pain worse?
Sometimes lying down for a while will help relieve abdominal discomfort.
Drink plenty of fluids (2-3 quarts every 24 hours), unless you have been told to restrict your fluids.
Take your medication with food unless you are specifically to take it on an empty stomach.
Avoid aspirin or products containing aspirin and NSAIDs (non-steroidal anti-inflammatory drugs, unless your doctor specifically prescribes them.
Avoid narcotic pain medications if they are not needed. Do not use for abdominal pain, unless recommended by your physician (the cause of the pain should be determined first).
Avoid drinking alcohol and smoking cigarettes; both can be irritating to your stomach.
If you experience cramping, you may try to relax and breathe deeply to assist in relief.
Eat bland foods in small amounts: similar to managing nausea and/or diarrhea.
Nausea/VomitingFoods to avoid during cancer treatments, to avoid abdominal pain:
Hot, spicy foods (i.e. hot pepper, curry, Cajun spice mix).
Fatty, greasy or fried foods.
Very sweet, sugary foods.
Large meals.
Foods with strong smells (foods that are warm tend to smell stronger).
Eating or drinking quickly.
Drinking beverages with meals.
Lying down after a meal.
Tips to try:
Small meals throughout the day.
Refrigerated or room temperature entrees.
Rinse mouth with lemon water after eating.
Suck on ice cubes, mints, or hard candies.
Distractions such as TV, music, or reading may be helpful while eating.
DiarrheaFoods to help avoid abdominal pain:
Hot, spicy foods (i.e. hot pepper, curry, Cajun spice mix).
High fiber foods (i.e. raw fruit and vegetables, coarse whole grains).
Fatty, greasy, or fried foods.
Rich desserts.
Nuts, seeds, or dried fruit.
Beverages to avoid during cancer treatments when experiencing abdominal pain:
Beverages that are very hot or cold.
Beverages containing caffeine (coffee, strong tea, soda, and possibly chocolate).
Use caution with milk products.
Tips to try to minimize or avoid cancer treatment-based abdominal pain:
Low total fiber or good soluble fiber source (i.e. rice, bananas, white bread, oatmeal, mashed potatoes, applesauce, skinless/boneless chicken or turkey).
Increase the amount of sodium (salt) and potassium in your diet.
Drink plenty of fluids.
In some cases, managing your abdominal pain may require some "trial and error" in terms of identifying things that may make it better or worse.
Drugs or recommendations that your health care provider may prescribe:
Although there are many over-the-counter remedies for abdominal pain, they are usually associated with other stomach problems as well. You should discuss taking any medications with your health care provider. Some medications include: Maalox®, Mylanta®, Pepto-Bismol®, and TUMS®.
If you are lactose intolerant, Lactaid® may help.
See also; Managing Heartburn, Managing Nausea, Managing Diarrhea or Managing Constipation, if applicable.
When to call your health care provider:
Seek emergency help and call your doctor immediately if you develop sudden severe abdominal pain that does not resolve in a few minutes, especially if accompanied by any of the following:
Sudden abdominal swelling.
Feeling faint, weak and dizzy.
Sweating
Fever of 100.5 or higher.
Sudden vomiting or vomiting blood.
Loss of consciousness.
A stiff board-like abdomen
Contact your health care provider within 24 hours if you experience:
Constant abdominal pain that does not go away with prescribed methods.
Cramping that does not go away after trying options listed above.
Nausea (interferes with ability to eat and unrelieved with prescribed medication).
Vomiting (vomiting more than 4-5 times in a 24 hour period).
Diarrhea (4-6 episodes in a 24-hour period).
Black or tarry stools, or blood in your stools.
If you have not had a bowel movement in three days despite following the recommendations of your doctor or health care professional.
If your stomach looks swollen and/or feels hard to the touch.
FLATULENCE (GAS)
What is flatulence and how is it affected by cancer treatment?
Flatulence, or gas, is actually a normal bodily function and, in fact, it is quite healthy. Socially, flatulence is fairly unacceptable but the fact remains...we all have "gas." Flatulence is the by-product of digestion, although when cancer treatment causes severe flatulence and/or lower abdominal pain, measures can be taken to minimize the treatment's effects. All food that enters the body is digested (broken down) into small parts (nutrients) to be absorbed into the bloodstream through the bowel wall and transported to other parts of the body.
Protein must be broken into amino acids, fats must be broken into fatty acids and carbohydrates must be broken down into glucose-like molecules. Nutrients that are not used are stored as fats or glycogen.
Sometimes, food is not completely broken down in the stomach or small intestine. There are a variety of reasons why food does not break down in the stomach or small intestine including lactose intolerance (the body lacks the enzyme lactase to break down lactose), for example. Once the food arrives in the large intestine, there are hundreds of bacteria (normal flora) that are available to help break down break down the undigested food. When this happens, a variety of gasses are released (much like the carbon dioxide released by yeast when making bread rise). These bacteria release gases like methane, hydrogen, and hydrogen sulfide. Hydrogen sulfide is the gas that causes odor.
Certain foods are more difficult to digest than other foods. Carbohydrates are the most flatulence-producing foods. Some of these include beans, bran, potatoes, fruits, vegetables (such as cabbage, broccoli, and cauliflower, onions, garlic) and even milk.
On a lighter note, flatulence, in addition to being known as gas, has also been referred to as toots, farts, honks, breaking wind and a variety of other home-concocted names.
Chemotherapy-induced abdominal pain, cramping and flatulence:
Chemotherapy can cause both increased (rapid) and decreased (slow) motility of the intestines. In other words, the normal wave-like action that moves stool through the bowel may be faster or slower than usual.
Rapid motility may cause stool to travel faster and be less formed. Rapid motility can be associated with cramping and/or diarrhea.
Slow motility may cause stool to travel slower, becoming harder and dryer and more difficult to pass. It may contribute to constipation and lower abdomen pain. Pain may be achy or cramp-like and may be associated with increased flatulence (gas).
Chemotherapy may also alter the normal bacterial flora that is present in the intestines. This can affect digestion and cause aching, cramping or flatulence (gas).
Steroids and other immunosuppressive medications may increase the probability of ulcers or other potentially serious abdominal complications such as perforation.
A history of or the development of lactose intolerance may contribute to worsening abdominal pain, cramping or flatulence (gas).
Cramping is a caused by a spasm (or contraction) of the bowel. It may be associated with the urge to move your bowels. It is not usually constant but comes more in "waves." It may be accompanied by either diarrhea, constipation or flatulence (gas).
Things you can do and cancer treatment-induced abdominal pain:
Drink plenty of fluids (2-3 quarts every 24 hours), unless you have been told to restrict your fluids.
Take your medication with food unless you are specifically to take it on an empty stomach.
Avoid aspirin or products containing aspirin and NSAIDs (non-steroidal anti-inflammatory drugs, unless your doctor specifically prescribes them.
Avoid narcotic pain medications if they are not needed. Do not use for abdominal pain.
Avoid drinking alcohol and smoking cigarettes; both can be irritating to your stomach.
If you are experience cramping, you may try to relax and breath deeply to assist in relief.
Eat bland foods in small amounts: Similar to managing nausea and/or diarrhea.
Nausea/VomitingFoods to avoid:
Hot, spicy foods (i.e. hot pepper, curry, Cajun spice mix).
Fatty, greasy or fried foods.
Very sweet, sugary foods.
Large meals.
Foods with strong smells (foods that are warm tend to smell stronger).
Eating or drinking quickly.
Drinking beverages with meals.
Lying down after a meal.
Tips for avoiding lower abdominal pain and flatulence while undergoing cancer treatments:
Small meals throughout the day.
Refrigerated or room temperature entrees.
Rinse mouth with lemon water after eating.
Suck on ice cubes, mints, or hard candies.
Distractions such as TV, music, or reading may be helpful while eating.
Diarrhea Foods to avoid:
Hot, spicy foods (i.e. hot pepper, curry, Cajun spice mix).
High fiber foods (i.e. raw fruit and vegetables, coarse whole grains).
Fatty, greasy, or fried foods.
Rich desserts.
Nuts, seeds, or dried fruit.
Beverages to avoid:
Beverages that are very hot or cold.
Beverages containing caffeine (coffee, strong tea, soda, and possibly chocolate).
Use caution with milk products.
Tips to try:
Low total fiber or good soluble fiber source (i.e. rice, bananas, white bread, oatmeal, mashed potatoes, applesauce, skinless/boneless chicken or turkey).
Increase the amount of sodium (salt) and potassium in your diet.
Drink plenty of fluids.
Drugs or recommendations that your health care provider may prescribe to combat flatulence and abdominal pain during and after cancer treatment:
There are over-the-counter remedies for flatulence. Most contain the ingredient simethicone. Some products include Gas-X® and Beano®. Also, some anti-acids contain simethicone. If you are lactose intolerant, Lactaid® may help. You should discuss taking any medications with your health care provider.
See also: Managing Heartburn, Managing Nausea, Managing Diarrhea or Managing Constipation, if applicable.
When to call your health care provider:
Contact your health care provider within 24 hours if you experience:
Constant abdominal pain that does not go away with prescribed methods.
Cramping that does not go away after trying options listed above.
Nausea (interferes with ability to eat and unrelieved with prescribed medication).
Vomiting (vomiting more than 4-5 times in a 24 hour period).
Diarrhea (4-6 episodes in a 24-hour period).
Black or tarry stools, or blood in your stools.
If you have not had a bowel movement in three days despite following the recommendations of your doctor or health care professional.
If your stomach looks swollen and/or feels hard to the touch.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.
http://www.chemocare.com/managing/abdominal_pain_and_cancer.asp
ABDOMINAL PAIN/CRAMPING
What is abdominal pain and abdominal cramping? What is their relationship to cancer and chemotherapy treatments?
The abdomen is the part of the body located between the chest and the pelvis. Most people refer to it loosely at the stomach (although the stomach is an organ within the abdomen). Pain is a personal experience of discomfort. Abdominal pain can be associated with a variety of conditions both within and outside or the abdomen. Abdominal or lower abdominal pain can be a dull ache, cramping, or sharp pain. Dull aches and cramping are not uncommonly associated with some chemotherapy drugs. Sharp pain that does not resolve in a few minutes may be an indicator of a more serious problem.
Cancer treatment-induced abdominal pain, cramping and flatulence (gas):
Chemotherapy can cause both increased (rapid) and decreased (slow) motility of the intestines. In other words, the normal wave-like action that moves stool through the bowel may be faster or slower than usual.
Rapid motility may cause stool to travel faster and be less formed. Rapid motility can be associated with cramping and/or diarrhea.
Slow motility may cause stool to travel slower, becoming harder and dryer and more difficult to pass. It may contribute to constipation. Pain may be achy or cramp-like and may be associated with increased flatulence (gas).
Chemotherapy may also alter the normal bacterial flora that is present in the intestines. This can affect digestion and cause abdominal pain, cramping or flatulence (gas).
Steroids and other immunosuppressive medications may increase the probability of ulcers or other potentially serious abdominal complications such as perforation.
A history of or the development of lactose intolerance may contribute to worsening abdominal pain, cramping or flatulence (gas).
Cramping is a caused by a spasm (or contraction) of the bowel. It may be associated with the urge to move your bowels. It is not usually constant but comes more in "waves". It may be accompanied by either diarrhea, constipation or flatulence (gas).
Things you can do to manage abdominal pain or cramping:
In order for your health care provider to assist you in managing your pain, it is helpful for you to be able to adequately describe your pain. One way to do this is by answering the following questions.
You may choose to keep a diary so that you can track your pain over time:
Onset - when did the pain start? What was I doing when I had pain?
Quality - what does the pain feel like? Is it knifelike and stabbing, or dull and constant?
Location - Where is the pain? Can I point to it with my finger, or is it spread all over?
Intensity - How bad is your abdominal pain all the time? How bad is it with certain activities that cause you to feel pain, on a 1-10 scale, with the number "10" being the worst pain imaginable?
Duration - How long did the pain last for? Is it while I was walking to the door, or did it continue for a while?
Character or aggravating factors - Does the pain come and go whenever I perform a certain activity, or is it unpredictable?
Relieving factors - What can I do to make the abdominal pain go away? Does anything help? What have I used in the past that have worked, and does this work now?
How is your mood? Are you depressed or anxious? Does this make the pain worse?
Sometimes lying down for a while will help relieve abdominal discomfort.
Drink plenty of fluids (2-3 quarts every 24 hours), unless you have been told to restrict your fluids.
Take your medication with food unless you are specifically to take it on an empty stomach.
Avoid aspirin or products containing aspirin and NSAIDs (non-steroidal anti-inflammatory drugs, unless your doctor specifically prescribes them.
Avoid narcotic pain medications if they are not needed. Do not use for abdominal pain, unless recommended by your physician (the cause of the pain should be determined first).
Avoid drinking alcohol and smoking cigarettes; both can be irritating to your stomach.
If you experience cramping, you may try to relax and breathe deeply to assist in relief.
Eat bland foods in small amounts: similar to managing nausea and/or diarrhea.
Nausea/VomitingFoods to avoid during cancer treatments, to avoid abdominal pain:
Hot, spicy foods (i.e. hot pepper, curry, Cajun spice mix).
Fatty, greasy or fried foods.
Very sweet, sugary foods.
Large meals.
Foods with strong smells (foods that are warm tend to smell stronger).
Eating or drinking quickly.
Drinking beverages with meals.
Lying down after a meal.
Tips to try:
Small meals throughout the day.
Refrigerated or room temperature entrees.
Rinse mouth with lemon water after eating.
Suck on ice cubes, mints, or hard candies.
Distractions such as TV, music, or reading may be helpful while eating.
DiarrheaFoods to help avoid abdominal pain:
Hot, spicy foods (i.e. hot pepper, curry, Cajun spice mix).
High fiber foods (i.e. raw fruit and vegetables, coarse whole grains).
Fatty, greasy, or fried foods.
Rich desserts.
Nuts, seeds, or dried fruit.
Beverages to avoid during cancer treatments when experiencing abdominal pain:
Beverages that are very hot or cold.
Beverages containing caffeine (coffee, strong tea, soda, and possibly chocolate).
Use caution with milk products.
Tips to try to minimize or avoid cancer treatment-based abdominal pain:
Low total fiber or good soluble fiber source (i.e. rice, bananas, white bread, oatmeal, mashed potatoes, applesauce, skinless/boneless chicken or turkey).
Increase the amount of sodium (salt) and potassium in your diet.
Drink plenty of fluids.
In some cases, managing your abdominal pain may require some "trial and error" in terms of identifying things that may make it better or worse.
Drugs or recommendations that your health care provider may prescribe:
Although there are many over-the-counter remedies for abdominal pain, they are usually associated with other stomach problems as well. You should discuss taking any medications with your health care provider. Some medications include: Maalox®, Mylanta®, Pepto-Bismol®, and TUMS®.
If you are lactose intolerant, Lactaid® may help.
See also; Managing Heartburn, Managing Nausea, Managing Diarrhea or Managing Constipation, if applicable.
When to call your health care provider:
Seek emergency help and call your doctor immediately if you develop sudden severe abdominal pain that does not resolve in a few minutes, especially if accompanied by any of the following:
Sudden abdominal swelling.
Feeling faint, weak and dizzy.
Sweating
Fever of 100.5 or higher.
Sudden vomiting or vomiting blood.
Loss of consciousness.
A stiff board-like abdomen
Contact your health care provider within 24 hours if you experience:
Constant abdominal pain that does not go away with prescribed methods.
Cramping that does not go away after trying options listed above.
Nausea (interferes with ability to eat and unrelieved with prescribed medication).
Vomiting (vomiting more than 4-5 times in a 24 hour period).
Diarrhea (4-6 episodes in a 24-hour period).
Black or tarry stools, or blood in your stools.
If you have not had a bowel movement in three days despite following the recommendations of your doctor or health care professional.
If your stomach looks swollen and/or feels hard to the touch.
FLATULENCE (GAS)
What is flatulence and how is it affected by cancer treatment?
Flatulence, or gas, is actually a normal bodily function and, in fact, it is quite healthy. Socially, flatulence is fairly unacceptable but the fact remains...we all have "gas." Flatulence is the by-product of digestion, although when cancer treatment causes severe flatulence and/or lower abdominal pain, measures can be taken to minimize the treatment's effects. All food that enters the body is digested (broken down) into small parts (nutrients) to be absorbed into the bloodstream through the bowel wall and transported to other parts of the body.
Protein must be broken into amino acids, fats must be broken into fatty acids and carbohydrates must be broken down into glucose-like molecules. Nutrients that are not used are stored as fats or glycogen.
Sometimes, food is not completely broken down in the stomach or small intestine. There are a variety of reasons why food does not break down in the stomach or small intestine including lactose intolerance (the body lacks the enzyme lactase to break down lactose), for example. Once the food arrives in the large intestine, there are hundreds of bacteria (normal flora) that are available to help break down break down the undigested food. When this happens, a variety of gasses are released (much like the carbon dioxide released by yeast when making bread rise). These bacteria release gases like methane, hydrogen, and hydrogen sulfide. Hydrogen sulfide is the gas that causes odor.
Certain foods are more difficult to digest than other foods. Carbohydrates are the most flatulence-producing foods. Some of these include beans, bran, potatoes, fruits, vegetables (such as cabbage, broccoli, and cauliflower, onions, garlic) and even milk.
On a lighter note, flatulence, in addition to being known as gas, has also been referred to as toots, farts, honks, breaking wind and a variety of other home-concocted names.
Chemotherapy-induced abdominal pain, cramping and flatulence:
Chemotherapy can cause both increased (rapid) and decreased (slow) motility of the intestines. In other words, the normal wave-like action that moves stool through the bowel may be faster or slower than usual.
Rapid motility may cause stool to travel faster and be less formed. Rapid motility can be associated with cramping and/or diarrhea.
Slow motility may cause stool to travel slower, becoming harder and dryer and more difficult to pass. It may contribute to constipation and lower abdomen pain. Pain may be achy or cramp-like and may be associated with increased flatulence (gas).
Chemotherapy may also alter the normal bacterial flora that is present in the intestines. This can affect digestion and cause aching, cramping or flatulence (gas).
Steroids and other immunosuppressive medications may increase the probability of ulcers or other potentially serious abdominal complications such as perforation.
A history of or the development of lactose intolerance may contribute to worsening abdominal pain, cramping or flatulence (gas).
Cramping is a caused by a spasm (or contraction) of the bowel. It may be associated with the urge to move your bowels. It is not usually constant but comes more in "waves." It may be accompanied by either diarrhea, constipation or flatulence (gas).
Things you can do and cancer treatment-induced abdominal pain:
Drink plenty of fluids (2-3 quarts every 24 hours), unless you have been told to restrict your fluids.
Take your medication with food unless you are specifically to take it on an empty stomach.
Avoid aspirin or products containing aspirin and NSAIDs (non-steroidal anti-inflammatory drugs, unless your doctor specifically prescribes them.
Avoid narcotic pain medications if they are not needed. Do not use for abdominal pain.
Avoid drinking alcohol and smoking cigarettes; both can be irritating to your stomach.
If you are experience cramping, you may try to relax and breath deeply to assist in relief.
Eat bland foods in small amounts: Similar to managing nausea and/or diarrhea.
Nausea/VomitingFoods to avoid:
Hot, spicy foods (i.e. hot pepper, curry, Cajun spice mix).
Fatty, greasy or fried foods.
Very sweet, sugary foods.
Large meals.
Foods with strong smells (foods that are warm tend to smell stronger).
Eating or drinking quickly.
Drinking beverages with meals.
Lying down after a meal.
Tips for avoiding lower abdominal pain and flatulence while undergoing cancer treatments:
Small meals throughout the day.
Refrigerated or room temperature entrees.
Rinse mouth with lemon water after eating.
Suck on ice cubes, mints, or hard candies.
Distractions such as TV, music, or reading may be helpful while eating.
Diarrhea Foods to avoid:
Hot, spicy foods (i.e. hot pepper, curry, Cajun spice mix).
High fiber foods (i.e. raw fruit and vegetables, coarse whole grains).
Fatty, greasy, or fried foods.
Rich desserts.
Nuts, seeds, or dried fruit.
Beverages to avoid:
Beverages that are very hot or cold.
Beverages containing caffeine (coffee, strong tea, soda, and possibly chocolate).
Use caution with milk products.
Tips to try:
Low total fiber or good soluble fiber source (i.e. rice, bananas, white bread, oatmeal, mashed potatoes, applesauce, skinless/boneless chicken or turkey).
Increase the amount of sodium (salt) and potassium in your diet.
Drink plenty of fluids.
Drugs or recommendations that your health care provider may prescribe to combat flatulence and abdominal pain during and after cancer treatment:
There are over-the-counter remedies for flatulence. Most contain the ingredient simethicone. Some products include Gas-X® and Beano®. Also, some anti-acids contain simethicone. If you are lactose intolerant, Lactaid® may help. You should discuss taking any medications with your health care provider.
See also: Managing Heartburn, Managing Nausea, Managing Diarrhea or Managing Constipation, if applicable.
When to call your health care provider:
Contact your health care provider within 24 hours if you experience:
Constant abdominal pain that does not go away with prescribed methods.
Cramping that does not go away after trying options listed above.
Nausea (interferes with ability to eat and unrelieved with prescribed medication).
Vomiting (vomiting more than 4-5 times in a 24 hour period).
Diarrhea (4-6 episodes in a 24-hour period).
Black or tarry stools, or blood in your stools.
If you have not had a bowel movement in three days despite following the recommendations of your doctor or health care professional.
If your stomach looks swollen and/or feels hard to the touch.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.
http://www.chemocare.com/managing/abdominal_pain_and_cancer.asp
Saturday, December 16, 2006
Why Health Professionals Become Quacks
William T. Jarvis, Ph.D. It is especially disappointing when an individual trained in the health sciences turns to promoting quackery. Friends and colleagues often wonder how this can happen. Some reasons appear to be:
Boredom. Daily practice can become humdrum. Pseudoscientific ideas can be exciting. The late Carl Sagan believed that the qualities that make pseudoscience appealing are the same that make scientific enterprises so fascinating. He said, "I make a distinction between those who perpetuate and promote borderline belief systems and those who accept them. The latter are often taken by the novelty of the systems, and the feeling of insight and grandeur they provide" [1] Sagan lamented the fact that so many are willing to settle for pseudoscience when true science offers so much to those willing to work at it.
Low professional esteem. Nonphysicians who don't believe their professions is sufficiently appreciated sometimes compensate by making extravagant claims. Dental renegades have said "All diseases can be seen in a patient's mouth." Fringe podiatrists may claim to be able to judge health entirely by examining the feet. Iridologists point to the eye, chiropractors the spine, auriculotherapists the ear, Registered Nurses an alleged "human energy field," and so on. Even physicians are not immune from raising their personal status by pretension. By claiming to cure cancer or to reverse heart disease without bypass surgery, general physicians can elevate themselves above the highly trained specialists in oncology or cardiology. By claiming to heal diseases that doctors cannot, faith healers advance above physicians on the social status chart (physicians are normally at the top of the chart while preachers have been slipping in modern times). Psychologists, physicians, actors, or others who become health gurus often become darlings of the popular press.
Paranormal tendencies. Many health systems are actually hygienic religions with deeply-held, emotionally significant beliefs about the nature of reality, salvation, and proper lifestyles. Vegetarianism, chiropractic, naturopathy, homeopathy, energy medicine, therapeutic touch, crystal healing, and many more are rooted in vitalism, which has been defined as "a doctrine that the functions of a living organism are due to a vital principle ["life force"] distinct from physicochemical forces" and "the theory that biological activities are directed by a supernatural force." [2,3] Vitalists are not just nonscientific, they are antiscientific because they abhor the reductionism, materialism, and mechanistic causal processes of science. They prefer subjective experience to objective testing, and place intuitiveness above reason and logic. Vitalism is linked to the concept of an immortal human soul, which also links it to religious ideologies [4].
Paranoid mental state. Some people are prone to seeing conspiracies everywhere. Such people may readily believe that fluoridation is a conspiracy to poison America, that AIDS was invented and spread to destroy Africans or homosexuals, and that organized medicine is withholding the cure for cancer. Whereas individuals who complain about conspiracies directed toward themselves are likely to be regarded as mentally ill, those who perceive them as directed against a nation, culture, or way of life may seem more rational. Perceiving their political passions are unselfish and patriotic intensifies their feelings of righteousness and moral indignation [5]. Many such people belong to the world of American fascism, Holocaust deniers, tax rebels, the radical militia movement, and other anti-government extremists who would eliminate the FDA and other regulatory agencies that help protect consumers from health fraud. Liberty Lobby's newspaper The Spotlight champions such causes and also promotes quack cancer cures and attacks fluoridation.
Reality shock. Everyone is vulnerable to death anxiety. Health personnel who regularly deal with terminally ill patients must make psychological adjustments. Some are simply not up to it. Investigation of quack cancer clinics have found physicians, nurses, and others who became disillusioned with standard care because of the harsh realities of the side effects or acknowledged limitations of proven therapies.
Beliefs encroachment. Science is limited to dealing with observable, measurable, and repeatable phenomena. Beliefs that transcend science fall into the realms of philosophy and religion. Some people allow such beliefs to encroach upon their practices. While one may exercise religious or philosophical values of compassion, generosity, mercy and integrity (which is the foundation of the scientific method's search for objective truth), it is not appropriate for a health professional to permit metaphysical (supernatural) notions to displace or distort scientific diagnostic, prescriptive or therapeutic procedures. Individuals who wish to work in the area of religious belief should pursue a different career.
The profit motive. Quackery can be extremely lucrative. Claiming to have a "better mousetrap" can cause the world to beat a path to one's door. Greed can motivate entrepreneurial practitioners to set ethical principles aside. The prophet motive. Just as Old Testament prophets called for conversion and repentance, doctors have to "convert" patients away from smoking, obesity, stress, alcohol and other indulgences [6]. As prognosticators, doctors foretell what is going to happen if patients don't change their way of life. The prophet role provides power over people. Some doctors consciously avoid it. They encourage patients to be self-reliant rather than dependent, but in doing so they may fail to meet important emotional needs. Quacks, on the other hand, revel in, encourage, and exploit this power. Egomania is commonly found among quacks. They enjoy the adulation and discipleship their pretense of superiority evokes.
Psychopathic tendencies. Studies of the psychopathic personality provide insight into the psychodynamics of quackery. Dr. Robert Hare who investigated for more than twenty years, states, "You find psychopaths in all professions. . . the shyster lawyer, the physician always on the verge of losing his license, the businessman with a string of deals where his partners always lost out." [7] Hare describes psychopaths as lacking a capacity to feel compassion or pangs of conscience, and as exhibiting glibness, superficial charm, grandiosity, pathological lying, conning/manipulative behavior, lack of guilt, proneness to boredom, lack of empathy, and other traits often seen in quacks. According to Hare, such people suffer from a cognitive defect that prevents them from experiencing sympathy or remorse.
The conversion phenomenon. The "brainwashing" that North Koreans used on American prisoners of war involved stress to the point that it produced protective inhibition and dysfunction. In some cases, positive conditioning causes the victim to love what he had previously hated, and vice-versa; and in other cases, the brain stops computing critically the impressions received. Many individuals who become quacks undergo a midlife crisis, painful divorce, life-threatening disease, or another severely stressful experience. The conversion theory is supported by a study of why physicians had taken up "holistic" practices. By far the greatest reason given (51.7%) was "spiritual or religious experiences." [8]
Many people -- including far too many health professionals, law enforcement officials, and judges -- exhibit a cavalier attitude toward quackery. Although most reject the idea that quackery is "worth a try" for a sick person [9], it is important to reinforce and mobilize those who understand quackery's harmful potential. References Reid WH and others. Unmasking the Psychopath. New York: W.W. Norton and Company, 1986. Webster's New Collegiate Dictionary. Dorland's Illustrated Medical Dictionary, 25th Edition. Philadelphia: WB Saunders Co. 1974. Sarton G. A History of Science, Volume I. New York: W.W. Norton & Company, 1952, p.497. Hofstadter R. The Paranoid Style in American Politics and Other Essays. New York: Alfred A. Knopf, 1966. Dominian J. Doctor as prophet. British Medical Journal 287:1925-1927, 1983. Goleman D. Brain defect tied to utter amorality of the psychopath. The New York Times, July 7, 1987. Goldstein MS, Jaffe DT, Sutherland C. Physicians at a holistic medical conference: Who and why?" Health Values 10:3-13, Sept/Oct 1986. Morris LA, Gregory J D, Klimberg R. Focusing an advertising campaign to combat medical quackery. Journal of Pharmaceutical Marketing and Management 2:(1):83-96, 1987.
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Boredom. Daily practice can become humdrum. Pseudoscientific ideas can be exciting. The late Carl Sagan believed that the qualities that make pseudoscience appealing are the same that make scientific enterprises so fascinating. He said, "I make a distinction between those who perpetuate and promote borderline belief systems and those who accept them. The latter are often taken by the novelty of the systems, and the feeling of insight and grandeur they provide" [1] Sagan lamented the fact that so many are willing to settle for pseudoscience when true science offers so much to those willing to work at it.
Low professional esteem. Nonphysicians who don't believe their professions is sufficiently appreciated sometimes compensate by making extravagant claims. Dental renegades have said "All diseases can be seen in a patient's mouth." Fringe podiatrists may claim to be able to judge health entirely by examining the feet. Iridologists point to the eye, chiropractors the spine, auriculotherapists the ear, Registered Nurses an alleged "human energy field," and so on. Even physicians are not immune from raising their personal status by pretension. By claiming to cure cancer or to reverse heart disease without bypass surgery, general physicians can elevate themselves above the highly trained specialists in oncology or cardiology. By claiming to heal diseases that doctors cannot, faith healers advance above physicians on the social status chart (physicians are normally at the top of the chart while preachers have been slipping in modern times). Psychologists, physicians, actors, or others who become health gurus often become darlings of the popular press.
Paranormal tendencies. Many health systems are actually hygienic religions with deeply-held, emotionally significant beliefs about the nature of reality, salvation, and proper lifestyles. Vegetarianism, chiropractic, naturopathy, homeopathy, energy medicine, therapeutic touch, crystal healing, and many more are rooted in vitalism, which has been defined as "a doctrine that the functions of a living organism are due to a vital principle ["life force"] distinct from physicochemical forces" and "the theory that biological activities are directed by a supernatural force." [2,3] Vitalists are not just nonscientific, they are antiscientific because they abhor the reductionism, materialism, and mechanistic causal processes of science. They prefer subjective experience to objective testing, and place intuitiveness above reason and logic. Vitalism is linked to the concept of an immortal human soul, which also links it to religious ideologies [4].
Paranoid mental state. Some people are prone to seeing conspiracies everywhere. Such people may readily believe that fluoridation is a conspiracy to poison America, that AIDS was invented and spread to destroy Africans or homosexuals, and that organized medicine is withholding the cure for cancer. Whereas individuals who complain about conspiracies directed toward themselves are likely to be regarded as mentally ill, those who perceive them as directed against a nation, culture, or way of life may seem more rational. Perceiving their political passions are unselfish and patriotic intensifies their feelings of righteousness and moral indignation [5]. Many such people belong to the world of American fascism, Holocaust deniers, tax rebels, the radical militia movement, and other anti-government extremists who would eliminate the FDA and other regulatory agencies that help protect consumers from health fraud. Liberty Lobby's newspaper The Spotlight champions such causes and also promotes quack cancer cures and attacks fluoridation.
Reality shock. Everyone is vulnerable to death anxiety. Health personnel who regularly deal with terminally ill patients must make psychological adjustments. Some are simply not up to it. Investigation of quack cancer clinics have found physicians, nurses, and others who became disillusioned with standard care because of the harsh realities of the side effects or acknowledged limitations of proven therapies.
Beliefs encroachment. Science is limited to dealing with observable, measurable, and repeatable phenomena. Beliefs that transcend science fall into the realms of philosophy and religion. Some people allow such beliefs to encroach upon their practices. While one may exercise religious or philosophical values of compassion, generosity, mercy and integrity (which is the foundation of the scientific method's search for objective truth), it is not appropriate for a health professional to permit metaphysical (supernatural) notions to displace or distort scientific diagnostic, prescriptive or therapeutic procedures. Individuals who wish to work in the area of religious belief should pursue a different career.
The profit motive. Quackery can be extremely lucrative. Claiming to have a "better mousetrap" can cause the world to beat a path to one's door. Greed can motivate entrepreneurial practitioners to set ethical principles aside. The prophet motive. Just as Old Testament prophets called for conversion and repentance, doctors have to "convert" patients away from smoking, obesity, stress, alcohol and other indulgences [6]. As prognosticators, doctors foretell what is going to happen if patients don't change their way of life. The prophet role provides power over people. Some doctors consciously avoid it. They encourage patients to be self-reliant rather than dependent, but in doing so they may fail to meet important emotional needs. Quacks, on the other hand, revel in, encourage, and exploit this power. Egomania is commonly found among quacks. They enjoy the adulation and discipleship their pretense of superiority evokes.
Psychopathic tendencies. Studies of the psychopathic personality provide insight into the psychodynamics of quackery. Dr. Robert Hare who investigated for more than twenty years, states, "You find psychopaths in all professions. . . the shyster lawyer, the physician always on the verge of losing his license, the businessman with a string of deals where his partners always lost out." [7] Hare describes psychopaths as lacking a capacity to feel compassion or pangs of conscience, and as exhibiting glibness, superficial charm, grandiosity, pathological lying, conning/manipulative behavior, lack of guilt, proneness to boredom, lack of empathy, and other traits often seen in quacks. According to Hare, such people suffer from a cognitive defect that prevents them from experiencing sympathy or remorse.
The conversion phenomenon. The "brainwashing" that North Koreans used on American prisoners of war involved stress to the point that it produced protective inhibition and dysfunction. In some cases, positive conditioning causes the victim to love what he had previously hated, and vice-versa; and in other cases, the brain stops computing critically the impressions received. Many individuals who become quacks undergo a midlife crisis, painful divorce, life-threatening disease, or another severely stressful experience. The conversion theory is supported by a study of why physicians had taken up "holistic" practices. By far the greatest reason given (51.7%) was "spiritual or religious experiences." [8]
Many people -- including far too many health professionals, law enforcement officials, and judges -- exhibit a cavalier attitude toward quackery. Although most reject the idea that quackery is "worth a try" for a sick person [9], it is important to reinforce and mobilize those who understand quackery's harmful potential. References Reid WH and others. Unmasking the Psychopath. New York: W.W. Norton and Company, 1986. Webster's New Collegiate Dictionary. Dorland's Illustrated Medical Dictionary, 25th Edition. Philadelphia: WB Saunders Co. 1974. Sarton G. A History of Science, Volume I. New York: W.W. Norton & Company, 1952, p.497. Hofstadter R. The Paranoid Style in American Politics and Other Essays. New York: Alfred A. Knopf, 1966. Dominian J. Doctor as prophet. British Medical Journal 287:1925-1927, 1983. Goleman D. Brain defect tied to utter amorality of the psychopath. The New York Times, July 7, 1987. Goldstein MS, Jaffe DT, Sutherland C. Physicians at a holistic medical conference: Who and why?" Health Values 10:3-13, Sept/Oct 1986. Morris LA, Gregory J D, Klimberg R. Focusing an advertising campaign to combat medical quackery. Journal of Pharmaceutical Marketing and Management 2:(1):83-96, 1987.
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Pipeline: Adhesion Barriers
A modern biomaterial for adhesion prevention.
Dizerega GS, Cortese S, Rodgers KE, Block KM, Falcone SJ, Juarez TG, Berg R.
Department of Obstetrics and Gynecology, Livingston Reproductive Biology Laboratories, Keck-USC School of Medicine, Los Angeles, California. A biomaterial composed of carboxymethylcellulose, poly(ethylene oxide), and calcium can be prepared in a variety of ways to reduce fibrin deposition and adhesion formation. This biomaterial platform can be formulated into a flowable gel with tissue adherence appropriate for use in minimally invasive surgery. The device remains at the site of placement even in gravitationally dependent areas. A peridural formulation was shown in preclinical studies to be safe and effective in reducing adhesions to dura following spinal surgery. A peritoneal formulation used on pelvic organs following peritoneal cavity surgery was also shown to be safe and effective. A clinical feasibility study showed that patients with severe back pain and lower extremity weakness treated with the peridural formulation, applied over their nerve roots following laminectomy or laminotomy, experienced significantly reduced symptoms when compared with surgery-only controls. The peritoneal formulation was shown in two multicenter feasibility studies of women undergoing pelvic surgery to significantly reduce adhesion formation when compared with surgery-only controls. Confirmation of the feasibility studies awaits results from pivotal clinical trials. These formulations were safe, effective, and easy to use. This biomaterial provided a benefit to patients undergoing surgery where postsurgical adhesion formation is a concern. (c) 2006 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2006. PMID: 16969823 [PubMed - as supplied by publisher]
A-part gel-An efficient adhesion prevention barrier.
Weis C, Odermatt EK. B. Braun Aesculap AG & Co. KG, R&D Closure Technologies, Postfach 40, 78501 Tuttlingen, Germany. Two different poly(vinyl alcohol)-based gels (A-Part Gel) were compared and evaluated as possible adhesion prophylaxis gels. The gels were implanted to act as a physical barrier-and thus to prevent adhesions-in a rabbit sidewall model. The absorption time of any adhesion barrier is a critical parameter, since the wounded tissue needs to be covered during the healing process. Crosslinking by freeze-thawing helped to prolong the absorption time of the gels. To better understand the in vivo absorption, the gels were investigated in various physical in vitro methods such as decay measurements and experiments performed in a Soxhlet extraction thimble. The in vivo applicability of the gels by surgeons was judged in squeezing force measurements. The ability to cover the wounded area securely was measured with simple spreading experiments. Both gels could be squeezed out of the syringes easily and showed a homogenous spreading behavior. Comparing the two gels, the results of the in vitro absorption experiments were contradictive. Further, in vivo tests with correlations to the proposed in vitro measurements will reveal the correct interpretation. Nevertheless, the results in a pilot rabbit sidewall model were excellent for both A-Part gels, but only one gel was chosen for extended studies, showing only 20% adhesions when compared with the control group showing 100% strong adhesion formations. These data will be evaluated in other studies, and the use of an A-Part PVA-CMC gel for adhesion prevention has to be supported in clinical studies. (c) 2006 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2006. PMID: 17106894 [PubMed - as supplied by publisher] J Biomed Mater Res B Appl Biomater.
Innovative barriers for peritoneal adhesion prevention: liquid or solid? A rat uterine horn model.
Wallwiener M, Brucker S, Hierlemann H, Brochhausen C, Solomayer E, Wallwiener C. Department of Obstetrics and Gynaecology, University of Tuebingen, Tuebingen, Germany. markus.wallwiener@aesconmed.de OBJECTIVE: To compare the effects of solid barriers (PDLA membrane and foil, Interceed), innovative barrier solutions (Adept and Hyalobarrier Gel, phospholipid emulsion), and Ringer's lactate solution in preventing postsurgical peritoneal adhesions in the rat. DESIGN: Prospective, randomized experimental study. SETTING: Rat model in an academic research environment. ANIMAL(S): Female, nonpregnant Wistar rats. INTERVENTION(S): Standardized surgical injuries were applied to the parietal and visceral peritoneum and the uterine horns. The barrier agents were applied and the wound was closed. A second-look laparoscopy was performed 31 days after surgery to assess adhesion formation. MAIN OUTCOME MEASURE(S): Severity and extent of adhesion formation assessed using a multidimensional adhesion scoring system. RESULT(S): Significantly fewer postsurgical adhesions were seen after treatment with Adept, Hyalobarrier Gel, Interceed, PDLA membrane, and phospholipid emulsion than after Ringer's lactate solution. Severe, clinically relevant adhesions were not observed after Hyalobarrier Gel and in only one animal after Adept. CONCLUSION(S): Both solid and liquid barriers can prevent adhesions. Hydroflotation formulas, such as Adept and Hyalobarrier Gel, avoid suture-induced adhesions, are easy to use, and their protective effects are evenly distributed. They are suitable for adhesion prevention after multifocal trauma in rats, and require further testing in the everyday clinical situation. PMID: 17008150 [PubMed - indexed for MEDLINE] Fertil Steril.
Dizerega GS, Cortese S, Rodgers KE, Block KM, Falcone SJ, Juarez TG, Berg R.
Department of Obstetrics and Gynecology, Livingston Reproductive Biology Laboratories, Keck-USC School of Medicine, Los Angeles, California. A biomaterial composed of carboxymethylcellulose, poly(ethylene oxide), and calcium can be prepared in a variety of ways to reduce fibrin deposition and adhesion formation. This biomaterial platform can be formulated into a flowable gel with tissue adherence appropriate for use in minimally invasive surgery. The device remains at the site of placement even in gravitationally dependent areas. A peridural formulation was shown in preclinical studies to be safe and effective in reducing adhesions to dura following spinal surgery. A peritoneal formulation used on pelvic organs following peritoneal cavity surgery was also shown to be safe and effective. A clinical feasibility study showed that patients with severe back pain and lower extremity weakness treated with the peridural formulation, applied over their nerve roots following laminectomy or laminotomy, experienced significantly reduced symptoms when compared with surgery-only controls. The peritoneal formulation was shown in two multicenter feasibility studies of women undergoing pelvic surgery to significantly reduce adhesion formation when compared with surgery-only controls. Confirmation of the feasibility studies awaits results from pivotal clinical trials. These formulations were safe, effective, and easy to use. This biomaterial provided a benefit to patients undergoing surgery where postsurgical adhesion formation is a concern. (c) 2006 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2006. PMID: 16969823 [PubMed - as supplied by publisher]
A-part gel-An efficient adhesion prevention barrier.
Weis C, Odermatt EK. B. Braun Aesculap AG & Co. KG, R&D Closure Technologies, Postfach 40, 78501 Tuttlingen, Germany. Two different poly(vinyl alcohol)-based gels (A-Part Gel) were compared and evaluated as possible adhesion prophylaxis gels. The gels were implanted to act as a physical barrier-and thus to prevent adhesions-in a rabbit sidewall model. The absorption time of any adhesion barrier is a critical parameter, since the wounded tissue needs to be covered during the healing process. Crosslinking by freeze-thawing helped to prolong the absorption time of the gels. To better understand the in vivo absorption, the gels were investigated in various physical in vitro methods such as decay measurements and experiments performed in a Soxhlet extraction thimble. The in vivo applicability of the gels by surgeons was judged in squeezing force measurements. The ability to cover the wounded area securely was measured with simple spreading experiments. Both gels could be squeezed out of the syringes easily and showed a homogenous spreading behavior. Comparing the two gels, the results of the in vitro absorption experiments were contradictive. Further, in vivo tests with correlations to the proposed in vitro measurements will reveal the correct interpretation. Nevertheless, the results in a pilot rabbit sidewall model were excellent for both A-Part gels, but only one gel was chosen for extended studies, showing only 20% adhesions when compared with the control group showing 100% strong adhesion formations. These data will be evaluated in other studies, and the use of an A-Part PVA-CMC gel for adhesion prevention has to be supported in clinical studies. (c) 2006 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2006. PMID: 17106894 [PubMed - as supplied by publisher] J Biomed Mater Res B Appl Biomater.
Innovative barriers for peritoneal adhesion prevention: liquid or solid? A rat uterine horn model.
Wallwiener M, Brucker S, Hierlemann H, Brochhausen C, Solomayer E, Wallwiener C. Department of Obstetrics and Gynaecology, University of Tuebingen, Tuebingen, Germany. markus.wallwiener@aesconmed.de OBJECTIVE: To compare the effects of solid barriers (PDLA membrane and foil, Interceed), innovative barrier solutions (Adept and Hyalobarrier Gel, phospholipid emulsion), and Ringer's lactate solution in preventing postsurgical peritoneal adhesions in the rat. DESIGN: Prospective, randomized experimental study. SETTING: Rat model in an academic research environment. ANIMAL(S): Female, nonpregnant Wistar rats. INTERVENTION(S): Standardized surgical injuries were applied to the parietal and visceral peritoneum and the uterine horns. The barrier agents were applied and the wound was closed. A second-look laparoscopy was performed 31 days after surgery to assess adhesion formation. MAIN OUTCOME MEASURE(S): Severity and extent of adhesion formation assessed using a multidimensional adhesion scoring system. RESULT(S): Significantly fewer postsurgical adhesions were seen after treatment with Adept, Hyalobarrier Gel, Interceed, PDLA membrane, and phospholipid emulsion than after Ringer's lactate solution. Severe, clinically relevant adhesions were not observed after Hyalobarrier Gel and in only one animal after Adept. CONCLUSION(S): Both solid and liquid barriers can prevent adhesions. Hydroflotation formulas, such as Adept and Hyalobarrier Gel, avoid suture-induced adhesions, are easy to use, and their protective effects are evenly distributed. They are suitable for adhesion prevention after multifocal trauma in rats, and require further testing in the everyday clinical situation. PMID: 17008150 [PubMed - indexed for MEDLINE] Fertil Steril.
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