Saturday October 23, 2004
Optional General Jackson Riverboat Cruise
Reservations and payments must be made in advance as the seating is limited.
| |Office of Research on Women's Health
Symposium on Family Hormonal Health
Pituitary tumors are not rare and occur in nearly 20% of adults, worldwide. Although clinically significant, many of these tumors go undiagnosed for years. The abnormal hormone production caused by these tumors has severe and debilitating effects on growth, reproductive and sexual function, and neuroimmune function. Therefore, the purpose of this symposium is to increase awareness and scientific understanding of the all-encompassing nature of pituitary disorders in order to increase earlier diagnosis, disseminate knowledge of state of the art treatments, and pique interest in novel scientific study of the pathophysiology of these disorders and their many ramifications.
MEETING LOCATION & TIME
The Symposium will be held from 8:30 a.m. - 6:00 p.m. on Friday, October 29, 2004. The Symposium will take place in the Lipsett auditorium of the NIH Clinical Center, on the NIH Campus in Bethesda, Maryland. For driving directions and information on getting to the meeting using METRO, please visit the travel page.
Participants attending the conference should be able to:
1. Describe the structure of the pituitary gland and its central importance in normal functioning and disease.
2. Improve diagnostic skills for earlier detection of disease across the lifespan in men and women.
3. Discuss current treatment options for pituitary tumors.
4. Recognize the neuroendocrine effects resulting from pituitary tumors on
the patient’s psychological state and psychosocial interactions and recommend appropriate intervention.
5. Develop a novel testable hypothesis to further continued scientific investigation in the understanding of pituitary disorders.
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the National Institutes of Health/Foundation for Advanced Education in the Sciences (NIH/FAES) and the Pituitary Network Association.
The NIH/FAES is accredited by the ACME to provide continuing medical education for physicians
7:30 - 8:30 Registration & Continental Breakfast (sponsored by PNA)
8:30 - 9:15
8:30 - 8:40 Introduction & Welcome
Vivian W. Pinn, M.D.
Associate Director for Research on Women's Health, NIH
Director, Office of Research on Women's Health
8:40 - 9:00 Family Hormonal Health: the Broader Picture
Yvonne Maddox, Ph.D.
National Institute of Child Health and Human Development
|9:00 - 9:15 Hormonal Disease is no Apparent Impediment to Good Health|
Captain Mohamed K. Shakir, M.D., F.A.C.P., F.R.C.P.
Director, Department of Endocrinology
National Naval Medical Center
Professor of Medicine
Uniformed Services University of the Health Sciences
9:20 - 1:00
|9:20 - 9:30 Session chair: Ian McCutcheon, M.D.|
Professor of Neuosurgery
University of Texas
M.D. Anderson Cancer Center
|9:30 - 10:05 The Pituitary Gland in Health and Disease|
Sylvia Asa , M.D., Ph.D.
Professor, Department of Laboratory Medicine and Pathobiology
University of Toronto
University Health Network and Toronto Medical Laboratories
|10:05 - 10:35 Impact of Hormonal Disorders in Childhood|
George P. Chrousos, M.D.
Chief, Pediatric and Reproductive Endocrinology Branch
National Institute of Child Health and Human Development
|11:00 - 11:30 The Transition Years: Neither Child nor Adult |
Alan Rogol , M.D., Ph.D.
Professor of Pediatrics
University of Virginia
|11:30-12:00 The Endocrinology of the Stress Response and Its Relevance to Depression, Anxiety, and Other States|
Phil Gold, M.D.
Chief, Clinical Neuroendocrinology Branch
National Institute of Mental Health
|12:00 -1:00 Three Personal Perspectives on Living with Hormonal Disorders|
Sharmyn McGraw, Bram Levy and Robert Knutzen
|1:00 - 2:00 Lunch|
2:00 - 5:30
|2:00 - 2:10 Session chair: Edward Oldfield, M.D.|
Chief, Surgical Neurology Branch,
National Institute of Neurological Diseases and Stroke
|2:10 - 2:40 The Young Male: What are his Options and Choices?|
Marc R. Blackman, M.D
National Center for Complimentary and Alternative Medicine
|2:40 - 3:10 A Young Woman's Hormonal World|
James Segars, M.D.
National Institute of Child Health and Human Development
|3:10 - 3:40 Hormonal Needs and Disorders in the Mature Female|
Janet A. Schlecte, M.D.
University of Iowa
|3:40 - 4:00 Break|
|4:00 -4:30 Surgical Treatment of Pituitary Disorders|
Edward Laws, M.D., Ph.D.
Professor of Neurosurgery & Medicine
University of Virginia
|4:30 - 5:00 Difficult Pituitary Problems: Options and Solution|
Ian McCutcheon, M.D.
Professor of Neurosurgery
University of Texas M.D. Anderson Cancer Center
5:00 - 5:45
|Moderator: Shereen Ezzat, M.D.|
Professor of Medicine and Oncology
Head, Endocine Oncology
University of Toronto
What do we Know, Where do we Go from Here and What is the Future Role of Research?
Drs. McCutcheon, Asa, Chrousos, Rogol, Laws, Oldfield and Schlechte
5:45 - 6:00
CLOSING REMARKS, ADJOURNMENT
For your convenience, a block of sleeping rooms has been reserved at the:
5151 Pooks Hill Road
Bethesda, MD 20814
In order to receive the government rate of $150 per night (plus tax) single/double, you must call Marriott reservations directly at 800.228.9290 and reference the group name "NIH-ORWH Joint Hormonal Symposium". You must make your hotel reservation by October 7, 2004 in order to receive the group rate. Rates and availability after that date will be cannot be guaranteed.
Shuttle service departs from the Bethesda Marriott for the NIH campus every 30 minutes, on the half-hour. Please inquire at the front desk for details.
GETTING TO NIH
We strongly encourage you to take METRO to the Natcher Conference Center, particularly in light of increased security measures recently instituted at NIH to ensure the safety of NIH employees and property. The Natcher Conference Center is a five-minute walk from the Medical Center station on METRO's Red Line. The Natcher Building is located on Center Drive directly behind the Medical Center stop.
NIH Campus Map - Washington Metrorail Map
If you must drive, take the Wisconsin Avenue exit from the Capital Beltway (I-495) and travel south on Wisconsin Avenue toward Bethesda. Drive approximately 1.5 miles on Wisconsin Avenue, then enter the NIH campus by turning right onto South Drive. At the bottom of the hill, turn left onto Center Drive. The Natcher Building is at 45 Center Drive and is located across from the Library of Medicine.
Please note that all visitor vehicles, including taxicabs, hotel and airport shuttles, delivery trucks and vans will be inspected before being allowed on campus. Visitors will be asked to show a photo ID and state the purpose of their visit. Be sure to allow extra time for this vehicle inspection procedure.
An alternative to driving onto the NIH campus is to drive to Bethesda and park in a public lot. From Bethesda you can either take the METRO (stop is located at East West Highway and Wisconsin Avenue) to the Medical Center stop or walk up Wisconsin Avenue to Center Drive (about a 10-15 minute walk). You may also drive and park at other METRO Stops on the Red Line that have public parking and take the Metro to the Medical Center station. Convenient stops include Rockville, White Flint, and Grovesnor.
Participants are responsible for their own travel expenses; however, ESI Travel is available to assist you in making your travel arrangements for this meeting if you wish. Please be aware ESI Travel charges a $45 service fee with all ticket reservations. If you wish to use this service, please contact our travel agent, Bridget Hanafin, by e-mail at email@example.com.
Please have the following information available when you call or email:
- Event name: ORWH Symposium
- Your arrival and departure dates and departure city
- Your seating preference (aisle, window) and preferred time frame for traveling
- Your email address and/or fax number
- Payment information (major credit card)
If you are planning to travel by air, remember that heightened security has been implemented at all airports. Please be prepared to furnish e-ticket itineraries and receipts, along with government-issued photo identification, upon check-in. Travelers are advised to arrive at the airport at least two hours prior to their scheduled departure to ensure ample time to clear security. Also, please keep in mind that check-in procedures and policies vary according to each airport and airline. Upon arrival at the airport, we suggest that you ask airline personnel whether you are permitted to check in at the gate, as opposed to the main ticket
Online registration for this meeting is now open. Registration is open to the public and there is no fee. To register for the meeting, please click on the link below
If you encounter any problems with the registration page, please contact us.
| || |
Presented by the Office of Research on Women's Health, Office of the Director, National Institutes of Health; the Pediatric and Reproductive Endocrinology Branch, the National Institute of Child Health and Human Development, National Institutes of Health; the Department of Endocrinology, United States Naval Medical Center, Department of Defense; and the Pituitary Network Association.
U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH
NIH Office of the Director (OD)
FOR IMMEDIATE RELEASE
Monday, October 18, 2004
NIH FAMILY HORMONAL HEALTH SYMPOSIUM: PITUITARY DISORDERS
The Office of Research on Women's Health will convene a Family Hormonal Health Symposium. The National Institutes of Health (NIH) Office of Research on Women's Health (ORWH; the Pediatric and Reproductive Endocrinology Branch, National Institute of Child Health and Human Development; the Department of Endocrinology, National Naval Medical Center; and the Pituitary Network Association are convening a symposium "Family Hormonal Health," on October 29, 2004, from 8:00 am - 6:00 pm in the Lipsett Amphitheater, (NIH Clinical Center - Bldg. 10) on the main campus of the NIH in Bethesda, Maryland.
Recent studies have shown that pituitary tumors are not rare and occur in nearly 20% of adults, worldwide. Although clinically significant, many of these tumors go undiagnosed for years. The abnormal hormone production caused by these tumors has severe and debilitating effects on growth, reproductive and sexual function, and neuroimmune function. The purpose of this symposium is to increase awareness and scientific understanding of the all-encompassing nature of pituitary disorders in order to increase earlier diagnosis, disseminate knowledge of state of the art treatments, and pique interest in novel scientific study of the pathophysiology of these disorders and their many ramifications.
The objectives of the conference are to describe the structure of the pituitary gland and its central importance in normal functioning and disease and to improve diagnostic skills for earlier detection of disease across the lifespan in men and women. It is critical to recognize that the neuroendocrine effects resulting from pituitary tumors not only mimic other conditions but also can have devastating effects on the patient's psychological state and psychosocial interactions. Current treatment options for pituitary tumors will be discussed and appropriate interventions recommended. It is hoped that researchers will be stimulated to develop testable hypotheses to further continued scientific investigation in the understanding of pituitary disorders.
Structured as a one-day, interactive meeting, the symposium will be co-chaired by Dr. Ian McCutcheon, M.D., Profesor of Neursurgery, University of Texas, M.D. Anderson Cancer Center and Edward Oldfield, M.D., Chief, Surgical Neurology Branch, National Institute of Neurological Disorders and Stroke.
Opening remarks will be given by Vivian W. Pinn, M.D., Associate Director for Research on Women's Health, Director, Office of Research on Women's Health, NIH who will provide an introduction and welcome; Yvonne Maddox, Ph.D., Deputy Director, National Institute of Child Health and Human Development who will speak on Family Hormonal Health: The Broader Picture; and Captain Mohamed K. Shakir, M.D., FACP, FRCP, Director, Department of Endocrinology, National Naval Medical Center and Professor of Medicine, Uniformed Services University of the Health Sciences will speak on Hormonal disease in healthy people. A detailed Agenda may be accessed at http://www.orwhsymposium.com.
Attendance at this symposium is open to the public. No registration fee is required but pre-registration should be made by registering on-line at http://www.orwhsymposium.com.
Continuing Medical Education is available for this symposium. Sign language interpretation will be provided.
This symposium is provided by the NIH Office of Research on Women's Health http://www4.od.nih.gov/orwh. Web users who have the latest free version of RealPlayer software on their computers may view this symposium live, or any other ORWH symposia and lectures via archive at http://videocast.nih.gov/PastEvents.asp?c=11.
The National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research. NIH is comprised of 27 institutes and centers and investigates the causes, treatments, and cures for both common and rare diseases.
This NIH News Release is available online at: http://www.nih.gov/news/pr/oct2004/od-18.htm
U.S. Department of Health and Human Services
Date: October 19, 2004
For Release: Immediately
Contact: HHS Press Office
Headline: HHS SAYS SUPPLY OF FLU VACCINES, MEDICINES WILL HELP KEEP PEOPLE SAFE DURING COMING FLU SEASON
Department Stockpiles Medicine, Coordinates Flu Response, Invests in New Technology
HHS Secretary Tommy G. Thompson said today that about 60 million doses of influenza vaccine combined with an ample supply of antiviral medicines -- potentially enough for more than 40 million people during the flu season -- puts America in a strong position to keep people safe during the upcoming flu season.
Secretary Thompson said the nation's cache of vaccine and medicines includes an additional 2.6 million doses of influenza vaccine that Aventis said today it will make available in January. The Centers for Disease Control and Prevention (CDC) also issued today interim guidance on the use of antiviral medicines for preventing and treating the flu. In addition, the formalization of a federal government task force will help ensure an ongoing coordinated effort to manage the supply of medicine and prevent price gouging.
"In addition to the 60 million doses of influenza vaccine, we have healthy supplies of antiviral medicines to help keep you safe from the flu," Secretary Thompson said. "While we don't have as much flu vaccine as we planned for, the combination of existing vaccine and antiviral medicines gives us the ability to stave off any harsh effects of the flu."
Secretary Thompson said the combined supply of influenza vaccine and antiviral medications precludes the need for seniors and others to stand in long lines waiting for vaccine. In addition, about 24 million doses of this influenza vaccine supply has yet to be distributed and will be steered toward the people and places who need it the most. He advised seniors seeking vaccine to be patient and persistent, keeping in contact with their doctors and public health departments.
"We are still in the early stages of the flu season, and millions more doses of the vaccine will be shipped in coming weeks, so there is still time to get vaccinated," Secretary Thompson said. "We understand the public's concerns about the loss of the Chiron flu vaccine, but they should know we have a healthy supply of vaccines and medicines to cope with flu season."
The Secretary noted that the government is exploring every option to replace some of the lost vaccine from other sources, and noted that the Bush administration has made unprecedented investments to protect against the flu. The President's investment in flu-related activities increased 720 percent since he took office -- from $39.3 million in 2001 to $283.1 million proposed for FY 05.
Vaccine For Most Vulnerable: The Secretary said the supply of 60 million doses of influenza vaccine includes about 58 million doses of Aventis vaccine and 2 million doses of FluMist nasal spray, and there is some potential more doses may be secured from other sources.
Secretary Thompson stressed that the influenza vaccine needs to go to those who are most vulnerable, including seniors 65 and older, young children age 6 months to 23 months, and pregnant women. He urged people not in the priority categories to forgo getting the flu vaccine because it takes a shot away from someone who needs it more.
"We need to get the influenza vaccine to those who need it most," Secretary Thompson said. "I want to thank those Americans who are helping out in the best traditions of this nation by forgoing their vaccines and leaving it for people who need it most."
Antiviral Medicines: The federal government has purchased and stockpiled antiviral medicines to treat more than 7 million people. Supplies of antiviral medicines also exist in the private sector and manufacturers indicate that they have the ability to significantly ramp up production. All told, between existing stockpiles, private sector supplies and production capabilities, the Food and Drug Administration (FDA) estimates there could be enough medicine to treat nearly 40 million people through the heart of flu season.
For the first time, the federal government created a stockpile of antiviral medicines under President Bush's leadership, specifically as a contingency if there were not enough flu vaccine. It includes enough doses of Rimantadine for 4.25 million adults and 750,000 children, and by December it will include enough Tamiflu for 2.3 million people. Two other antiviral products on the marketplace to help prevent and treat the flu are Amantadine and Zanamivir.
CDC today issued new interim guidelines on the use of these antiviral medicines in the prevention and treatment of flu for this coming season. They are available at www.cdc.gov.
"We stockpiled antivirals and vaccines, as well as created plans for prioritizing who gets the vaccine, in preparation for the possibility of a vaccine shortage," Secretary Thompson said. "These medicines will help us address the flu, particularly for those most vulnerable."
Federal Task Force: The Secretary also announced the formalization of a federal task force that will coordinate our nation's efforts to ensure that the flu vaccine and treatment medication goes to those who need it most and without any price gouging. Secretary Thompson said marshalling all the resources of the federal government -- including the health agencies, Department of Justice, Federal Trade Commission, Homeland Security and Veterans Affairs -- will help ensure that all aspects of flu season are being addressed for the American public.
The Flu Action Task Force will also continue ongoing partnerships with the private sector in addressing challenges of the flu season, including the public health community, physicians, law enforcement and prosecutors, trade associations and advocacy groups.
"From the time we learned about our loss of the Chiron vaccine, a strong partnership between federal agencies, the private sector and the public health and law enforcement communities has helped us rapidly and effectively address the challenges before us," Secretary Thompson said. "It's important that we keep these partnerships strong during flu season, this year and beyond."
Transforming the Flu Vaccine Marketplace for 21st Century
President Bush has invested more in research, development and acquisition of flu vaccines and medicines than any President in our nation's history in an effort to revitalize a deteriorated flu vaccine marketplace and better protect the American people.
In 1994, there were five injectable influenza vaccine manufacturers: Wyeth, Evans (now part of Chiron), Connaught (now part of Aventis), Parke Davis and Lederle; today there are two - Aventis and Chiron.
The high risks of complex vaccine production, unpredictable consumer demand and low profit margins, coupled with the lack of liability protection from costly lawsuits, drove many manufacturers out of the flu vaccine business during the 1990s.
Getting manufacturers back into the marketplace is further complicated by the length of time for a new manufacturing facility to come on-line -- five years or more. The FDA has high standards for flu vaccine production, including good manufacturing processes, which ensure the safety and efficacy of vaccines. These high standards helped keep 46 million doses of contaminated vaccine produced by Chiron from making it into the arms of Americans this year.
A record of solutions
Immediately upon coming to HHS, Secretary Thompson under the leadership of President Bush began transforming the flu marketplace by investing in new technologies, securing more vaccines and medicines, and preparing stronger response plans. Actions the Administration has taken include:
Unprecedented Investments: The largest investments ever made by the federal government in protecting against the flu have been made under President Bush's leadership. This includes increases for CDC Flu Funding: $17.2 million to $41.6 million (242 percent increase); National Institutes of Health Research and Development: $20.6 million to $65.9 million (320 percent); FDA Research and Licensing: $1.5 million to $2.6 million (173 percent increase); Creation of Strategic Reserves/Stockpiles: $0 to $80 million. These investments are further detailed below.
New Technologies: In each of the last two budgets, HHS has asked for $100 million to shift vaccine development from the cumbersome egg-based production to new cell-culture technologies, as well as to provide for year-round availability of eggs to provide for a secure supply and surge capacity. HHS received $50 million in the fiscal year 2004 budget, and Secretary Thompson urges Congress to fully fund the $100 million request for 2005.
These new technologies will help produce flu vaccine more efficiently and provide more adaptability to unexpected problems or losses in production.
Creating the Nation's First Stockpiles of Medicines: This Administration is the first to create stockpiles of both influenza vaccine and antiviral medications. The department invested $40 million in 2004, and seeks another $40 million in 2005, to stockpile influenza vaccine through the Vaccines for Children Program. It invested $87.1 million to stockpile 2.3 million doses of Tamiflu. And it invested $34 million on Rimantadine capsules to treat 4.25 million adults and Rimantadine syrup to treat 750,000 kids.
These stockpiles give the government new ability to protect the most vulnerable, and respond effectively when there is a shortage of vaccine.
Pandemic Flu Plan: In August, Secretary Thompson unveiled the department's draft Pandemic Influenza Response and Preparedness Plan. This plan outlines a coordinated national strategy to prepare for and respond to a flu pandemic. One of the first internal committees the Secretary created when he came to HHS was on the pandemic flu.
Improving Access by Covering Costs: The Centers for Medicare & Medicaid Services (CMS) has more than doubled the payment rates for the vaccine and its administration since 2000. In 2004, CMS is paying $18.30 for the vaccine and administration -- up from $8.92 in 2000. This is helping to make sure the vaccine is affordable for patients to get and cost-effective for providers to administer.
"The marketplace is full of disincentives for manufacturers to produce the vaccine," Secretary Thompson said. "We're making progress in reversing this environment. We need to build upon our efforts to transform the marketplace so manufacturers get into the flu vaccine business without the fear of being driven out by lost costs from production and high costs from lawsuits."
Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.
How to Ward Off the Flu This Winter
The wisdom mothers have been dispensing for ages -- wash your hands, eat your vegetables, go to bed earlier -- turns out to be great advice for avoiding the flu.
Doctors and nutritionists say careful hygiene, a balanced diet and plenty of rest and fluids can go a long way toward keeping people healthy during the influenza season, especially considering this year's vaccine shortage.
"Taking care of yourself from a health standpoint is probably the best thing you can do," said Dr. R. Michael Gallagher, a family physician and dean of the University of Medicine and Dentistry of New Jersey's School of Osteopathic Medicine.
"People who are run down, they're overworked, not getting proper rest or proper nutrition, these people increase their risk" of illness, he said.
Besides getting enough sleep -- at least seven hours a night for adults and more for youngsters -- managing stress is important, Gallagher said, because too much can weaken one's immune system.
Frequent hand-washing, using soap and hot water and rubbing vigorously for about half a minute, also is crucial.
"What you want to do it is try to interrupt transmission of disease with the kinds of things our mothers taught us," said Dr. Mitchell Cohen of the federal Centers for Disease Control and Prevention.
Avoid touching your eyes, nose or mouth, because germs on your hand could infect you, he said. And, if you do get the flu, stay home from work or school so you don't infect others.
The United States will get only half its expected supply of flu vaccine this year because British health authorities suspended the license of vaccine producer Chiron Corp. at the company's Liverpool, England, factory because of contamination.
Cohen said the CDC is planning two public education campaigns, first to explain the shortage and who should or shouldn't get vaccinated, and second to teach people how to protect themselves through hygiene and "cough etiquette."
The old advice was to cough or sneeze into your hands, then wash them, but children and many adults don't wash up immediately. That means they can spread the flu virus or other germs via a handshake or touching a doorknob, computer keyboard or other surface, where those germs can live for hours. Now doctors are urging that, if a tissue isn't at hand, people -- especially children -- should sneeze into their sleeve.
"Doctors have been emphasizing this in the last several years," said Dr. Ron Davis, an American Medical Association trustee and preventive medicine specialist.
Davis said hand sanitizers are a good option when soap and water aren't available, but anti-bacterial soaps offer little benefit.
Another new piece of advice is to stop refilling the bottles of water so many of us carry.
The bottles accumulate germs and shouldn't be reused or shared, said American Dietetic Association spokeswoman Gail Frank, a professor of nutrition at California State University-Long Beach. But don't skip the water, because eight glasses of fluid a day is essential to health, aiding in almost every process in the body.
People, especially the elderly and those in poor health, also should avoid crowds and people who are coughing or sneezing, said Dr. Michele Bachhuber, an internal medicine specialist at Marshfield Clinic in Marshfield, Wis.
"Regular exercise helps boost our immune system, so that's important, too," she said.
Then there's the role of diet. Frank said it's crucial to eat a healthy and substantial breakfast, about one-fourth of the day's calories.
Variety in the diet is important, but people should emphasize plant foods, including whole grains and at least five servings of fruits and vegetables a day, said Elisa Zied, another American Dietetic Association spokeswoman and a registered dietitian in New York.
She said people can help keep their immune system strong by eating foods rich in vitamins A, C and E: milk, eggs and fish oil; citrus fruits, melons and red peppers; and nuts, spinach, peanut butter and corn oil.
Moms, doctors and health officials have been dispensing most of this advice for decades, but many people clearly forget or ignore it.
"We always worry about the healthy behavior fading over time as the crisis subsides, so we have to keep reminding people about the benefits of good hygiene and vaccination and taking care of themselves," said Davis, of the AMA. "I expect that people will listen more carefully ... because many people are going to have a hard time getting their flu shot."
Source: Associated Press. Powered by YellowBrix, Inc.
Survey Suggests Women with Prevalent Incurable Hormonal Disorder Understand the Importance of and Seek Self-Help Lifestyle Modification Services
Lack of Insurance for Self-Help Services Could Prove Obstacle for the Millions of Women with Polycystic Ovary Syndrome Seeking to Prevent Diabetes and Heart Disease
PHILADELPHIA, and SYLVA, N.C., Oct. 18 /PRNewswire/ -- Women with Polycystic Ovary Syndrome (PCOS), an incurable hormonal disorder which affects 10% of all reproductive age women, understand the importance of and seek self- help lifestyle modification support services, according to the results of a survey conducted by PCOStrategies, Inc. and the Reproductive Associates of Delaware. PCOS, which previous research has shown is best treated through lifestyle intervention, is a leading cause of infertility and if left untreated long term risks include the development of chronic diseases such as diabetes, heart disease and endometrial cancer. These results are being presented Wednesday, October 20, 2004 at 2:15 p.m. EDT at the American Society of Reproductive Medicine's Annual Meeting in Philadelphia, which is currently in progress.
Lesa Childers, MSW, President & CEO, PCOStrategies and board members Ronald Feinberg, M.D., Ph.D. and Barbara McGuirk, M.D., of Reproductive Associates of Delaware sought to determine the attitude, motivation, level of importance and cost thresholds of self-help life management options considered beneficial to women with PCOS. The issues of relevance to women with PCOS were incorporated into an Internet-based Likert questionnaire, which assessed respondents' level of interest in seeking professional services to improve their metabolic and emotional well-being. In addition, the survey sought information about respondents' willingness to utilize doctor-referred programs for improving nutrition and positive attitude.
The survey found that women with PCOS understand the importance of professional services that focus on their health, fertility and emotional well-being. They recognize the value and would even embrace referrals by their physicians to group and/or individualized life management programs with 78 percent expressing an interest in life management programs, 49 percent preferring weekly group sessions while 44 percent desired individualized counseling. They would prefer more frequent visits to their physicians while working to heal their underlying metabolic syndrome with 57 percent desiring weekly visits. However, access to insurance reimbursements for these activities may prove to be a hindrance for many women as only 15 percent of women expressed a willingness to participate with 25 percent or less insurance coverage.
The most common endocrine disorder in women, PCOS is a complex hormonal disorder effecting approximately 10 percent of reproductive-age women worldwide. Previous research has pinpointed its cause to the body's failure to respond to insulin correctly resulting in an excess of insulin, which further creates an imbalance with other bodily hormones. PCOS symptoms include lack of, infrequent or irregular menstrual cycles, infertility, hirsutism or excessive body or facial hair growth, weight gain, obesity, baldness and thinning hair, adult acne, depression, skin tags or teardrop- shaped pieces of skin and acanthosis nigricans or patches of rough brown to black skin.
"The willingness of those with PCOS to embrace lifestyle changes has long been a question of ours," said Ronald Feinberg, M.D., Ph.D., Chairman of the Professional Advisory Board for PCOStrategies and author of the new book "Healing Syndrome O". "This survey confirms that the majority of women with PCOS are not only willing but are seeking lifestyle modification services to improve their health and are looking for their treating medical professionals to provide more guidance."
PCOStrategies is a national non-profit organization dedicated to educating, motivating and stimulating women with PCOS and Syndrome O. Their mission is to assist women with PCOS in the development of a healthy lifestyle through their Syndrome O Coaching Services and Survival Strategies Programs, O Rounds Magazine and online support services to enhance fertility and overall well-being. Comprised of leaders in their respective fields, PCOStrategies has successfully helped many women with PCOS to realize better health and well-being and to conceive.
For more information visit http://www.asrm.org or http://www.pcostrategies.org.
About PCOStrategies, Inc.
Founded in 2003 and headquartered in Sylva, NC, PCOStrategies, Inc. is a national non-profit organization dedicated to educating, motivating and stimulating women with PCOS and Syndrome O. Their mission is to assist women with PCOS in the development of a healthy lifestyle through their Syndrome O Coaching Services and Survival Strategies Programs, O Rounds Magazine and online support services to enhance fertility and overall well-being. Comprised of leaders in their respective fields, PCOStrategies has successfully helped many women with PCOS to realize better health and well- being and to conceive.
SOURCE PCOStrategies, Inc.
CO: PCOStrategies, Inc.
ST: Pennsylvania, North Carolina
SU: SVY WOM NPT
Web site: http://www.asrm.org
10/18/2004 08:56 EDT
Polycystic Ovary Syndrome May Lead to Diabetes, Cardiovascular Disease
Oct. 7, 2004 (New York) — Treating metabolic and cardiovascular risk factors associated with polycystic ovary syndrome (PCOS) could reduce the incidence of serious medical consequences, according to a position statement from the American Association of Clinical Endocrinologists (AACE).
"Physicians should no longer regard PCOS as a cluster of annoying cosmetic complaints, or a condition primarily associated with infertility," but as a condition linked to metabolic disorders "that may be associated with type 2 diabetes mellitus and cardiovascular events," the position paper states.
No large, prospective longitudinal studies definitively link PCOS to diabetes or cardiovascular disease. However, many expert endocrinologists now believe the evidence is finally compelling enough to merit a formal warning.
"Data has been building up for the last 15 years," said Rhoda H. Cobin, MD, chair of the AACE task force on PCOS. "This is the first time anybody has put everything together and come forward to say, 'we need a call to action.' "
Women with PCOS often receive treatment for infertility and non–life-theatening symptoms such as acne and hirsutism. However, many also have an underlying metabolic disorder, characterized by insulin resistance, which often goes untreated, according to experts who drafted the position paper.
Call to Action
The AACE is the first professional society to come out with a statement strongly endorsing the need to recognize underlying medical risks in PCOS, a condition "that heretofore has not been seen as a significant risk factor for illness and death," Dr. Cobin told Medscape.
Today, many PCOS patients receive treatment only for infertility or cosmetic issues, and later in life they develop overt diabetes or coronary disease, she added.
The organization is calling for "widespread case finding" of PCOS, along with screening and treatment for the "hidden risks" of the condition, including myocardial infarction, stroke, and the complications of uncontrolled diabetes, such as retinopathy, kidney failure, and amputation.
Treatment may reduce risk of early death and debilitating complications. The experts recommend lifestyle modification, emphasizing exercise, controlled eating, and tobacco avoidance. Medication to treat diabetes, hypertension, and lipid abnormalities may be considered, depending on the patient.
The antihyperglycemic drug metformin (Glucophage) should be considered in "most women with PCOS as initial therapy" because it can improve metabolic abnormalities and may improve potential for pregnancy. Although metformin is not approved for use in PCOS, "abundant literature" supports its efficacy in this setting, experts said.
Simply identifying PCOS remains a major challenge. Most women see several physicians before receiving a definitive diagnosis. "This is the whole tragedy," said Walter Futterweit, MD, a PCOS expert who wrote the first textbook on the condition in 1984.
"It's getting a little better, as more lectures and literature are coming out, but even some endocrinologists...are still not aware of the intricacies," said Dr. Futterweit, a clinical professor of medicine at Mount Sinai School of Medicine in New York City.
Approximately 10% of reproductive-age women have PCOS, making it the most common metabolic abnormality in young women, according to AACE.
Most experts base the diagnosis of PCOS on a history of irregular menstrual cycles and anovulation, along with the presence of hyperandrogenism, ruling out similar hormonal disorders such as hyperprolactinemia or Cushing's syndrome. At least half of women with PCOS meet obesity criteria.
Insulin resistance with compensatory hyperinsulinemia is a common clinical feature of PCOS, occurring in at least 75% of these patients, recent reports show. Consequently, experts said in the position paper, women with PCOS should be evaluated for components of the insulin resistance syndrome (IRS), a cluster of clinical syndromes and abnormalities such as low levels of high-density lipoprotein cholesterol, increased triglycerides levels, hypertension, and insulin resistance with increased tendency toward type 2 diabetes mellitus.
Since 2001, AACE has recommended that women with PCOS be screened for diabetes by the age of 30 years because multiple investigations have suggested diabetes and its complications may develop at a relatively young age.
Evidence of Harm
In the Nurses' Health Study, which included more than 116,000 women aged 25 to 42 years who were followed for eight years, incidence of type 2 diabetes mellitus was increased by 2.0- to 2.5-fold in women with a history of abnormal or infrequent menstrual cycles. That finding is "highly suggestive" of PCOS as a risk factor for diabetes, because about 80% of women with irregular menstrual cycles have underlying PCOS, according to the authors of the AACE position paper.
Women with PCOS also appear to be prone to hypertension and atherosclerosis, and separate investigations have found these patients may have increased levels of coronary artery calcification and carotid intima media thickness, two "major" surrogate markers for cardiovascular risk factors, the authors stated.
There are no prospective, longitudinal studies assessing cardiovascular outcomes in PCOS patients. A number of retrospective epidemiologic studies have been completed. Most, but not all, of those studies confirmed increased risk of cardiovascular events. Notably, the Nurses' Health Study results suggest a twofold increased risk for nonfatal myocardial infarction in women with irregular menstrual cycles.
"It is likely that a large proportion of these women had PCOS, yielding indirect confirmation of increased adverse cardiovascular outcomes," according to the position paper.
Reviewed by Gary D. Vogin, MD
Andrew Bowser is a freelance writer for Medscape.
Ferring Introduces Bravelle(R) With First Needle-Free Reconstitution Device
Q-Cap(TM) Previewed at Annual ASRM Meeting
PHILADELPHIA, Oct. 18 /PRNewswire/ -- Ferring Pharmaceuticals introduced today the Q-Cap(TM), the first device enabling needle-free reconstitution (process of dissolving medication in diluent) of fertility treatments. It is for exclusive use with the Company's human-derived fertility treatments and will be packaged with Bravelle(R) (urofollitropin for injection, purified). The device allows user-friendly reconstitution of medication(s) in a single vial, in single or mixed protocols, simplifying preparation for injection, and eliminating product waste and accidental needle sticks. The Q-Cap(TM) was previewed at the 60th Annual Meeting of the American Society for Reproductive Medicine (ASRM) in Philadelphia, October 16-20, 2004.
"In a recent survey by the International Council on Infertility Information Dissemination (INCIID), 77% of the 537 in vitro fertilization (IVF) polled patients reported reconstitution as the most stressful part of IVF therapy," said William Garbarini, director of marketing, Ferring Pharmaceuticals. "Part of that stress was specifically attributed to the use of needles. Since the Q-Cap(TM) is needle-free, it eliminates patients' anxiety associated with needle use during this process and increases comfort levels, making patients more confident in their self-treatment while ensuring that the full prescribed medication dose is administered from the vial."
The Q-Cap(TM) provides fast and easy reconstitution that is consistent with the traditional needle and syringe injection method that patients have become accustomed to and may need to use with other medications prescribed during their treatment cycle. It allows patients to easily withdraw the full contents of each vial needle-free. It does not interfere with the patient's ability to withdrawal her full dose without wasting product.
The device can also be used with Ferring's Repronex(R) (menotropins for injection, USP) fertility treatment.
How Q-Cap(TM) Works
For reconstitution, the patient twists the Q-Cap(TM) onto the syringe, pushes the tip through the diluent vial's rubber stopper, and pulls back on the plunger to remove the diluent. Next, the patient places the Q-Cap(TM) on the vial containing the Bravelle(R) or Repronex(R) powder, pushes the tip into the rubber stopper, then slowly injects the diluent into the vial and swirls the diluent and medication until the medication is dissolved. The solution can be used to dissolve up to six vials in one syringe.
The Q-Cap(TM) can be used to reconstitute medication(s) in one syringe regardless of protocol and allows the patient to administer only one injection per day. If more than one medication is required, the patient simply repeats the process with the additional vial(s) of medication(s) before attaching the injection needle to the vial. This improved reconstitution process reduces time required to educate patients since it mirrors the reconstitution process with the standard needle and syringe technique, eliminates accidental needle sticks and eliminates product waste.
"The Q-Cap(TM) is a new feature designed to make self-treatment with Bravelle(R) easier and less stressful for patients," said Dr. Richard T. Scott, Jr., Director and Managing Partner of Reproductive Medicine Associates of New Jersey. "Another benefit of the Q-Cap(TM) is that it requires only one injection in mixed protocols, whereas other devices require at least two. By using the Q-Cap(TM), different ratios of Bravelle(R) and Repronex(R) can be delivered in one syringe to meet individual patient needs."
The Q-Cap(TM) will be commercially available in late 2004. For more information, complete instructions for use and a video demonstrating the reconstitution process with Q-Cap(TM), please visit http://www.ferringfertility.com.
About Bravelle(R) and Repronex(R)
Bravelle(R), a highly purified human-derived follicle-stimulating hormone (hFSH) for infertility treatment, contains 75 IU of FSH and up to two percent LH activity. Bravelle(R), administered SC or IM in conjunction with hCG, is indicated for ovulation induction following pituitary suppression. Bravelle(R), administered SC in conjunction with hCG, is also indicated for multiple follicular development during ART cycles in patients who have previously received pituitary suppression.
Repronex(R) is the only human menopausal gonadotropin (hMG) on the market and is approved for both subcutaneous and intramuscular administration. Bravelle(R) and Repronex(R), like all gonadotropins, are potent substances capable of causing mild to severe adverse reactions, including OHSS (incidence of 6.0% and 3.5%, respectively), with or without pulmonary or vascular complications, in women undergoing therapy for infertility.
Both treatments are marketed by Ferring Pharmaceuticals Inc., a world leader in naturally occurring protein hormones. Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe these medications. Like other products for ovarian stimulation, treatment with Repronex(R) and/or Bravelle(R) may result in multiple gestations.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals, part of the Ferring Group, a privately owned, international pharmaceutical company, markets Bravelle(R), Repronex(R) and Novarel(TM) in the U.S. to infertility specialists and their patients. The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology and infertility. For more information, call 888-337-7464 or visit http://www.ferringusa.com or http://www.ferringfertility.com.
SOURCE Ferring Pharmaceuticals
CO: Ferring Pharmaceuticals
ST: Pennsylvania, Denmark
10/18/2004 08:30 EDT