Webcast from NIH Office of Research on Women's Health
Arkansas Receives More Flu Vaccine
Symposium on Family Hormonal Health
Webcast: NIH, Friday, October 29, 2004 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
- Vivian W. Pinn, M.D.
Associate Director for Research on Women's Health, NIH
Director, Office of Research on Women's Health
- Family Hormonal Health: the Broader Picture
Yvonne Maddox, Ph.D.
National Institute of Child Health and Human Development
- 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
- Ian McCutcheon, M.D.
Professor of Neuosurgery
University of Texas
M.D. Anderson Cancer Center
- 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
- 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
- The Transition Years: Neither Child nor Adult
Alan Rogol, M.D., Ph.D.
Professor of Pediatrics
University of Virginia
- 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
- Three Personal Perspectives on Living with Hormonal Disorders
Sharmyn McGraw, Bram Levy and Robert Knutzen
- Edward Oldfield, M.D.
Chief, Surgical Neurology Branch,
National Institute of Neurological Diseases and Stroke
- The Young Male: What are his Options and Choices?
Marc R. Blackman, M.D
National Center for Complimentary and Alternative Medicine
- A Young Woman's Hormonal World
James Segars, M.D.
National Institute of Child Health and Human Development
- Hormonal Needs and Disorders in the Mature Female
Janet A. Schlecte, M.D.
University of Iowa
- Surgical Treatment of Pituitary Disorders
Edward Laws, M.D., Ph.D.
Professor of Neurosurgery & Medicine
University of Virginia
- Difficult Pituitary Problems: Options and Solution
Ian McCutcheon, M.D.
Professor of Neurosurgery
University of Texas M.D. Anderson Cancer Center
- PANEL DISCUSSION
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
View this Webcast (7 hours, 21 minutes)
Webcast: ENDO 2004: from Controversies in the Treatment of Obesity to the differential diagnosis of Cushing's Syndrome or Thyroid Cancer, ENDO Webcast includes a diverse array of the clinical symposia presented at ENDO 2004. This easy to view format includes slide graphics. This requires Real Player, avaliable free from http://www.real.com
Discovery Health will air Sam's show, "Mystery Diagnosis", Monday, November 15, 10PM EST More info here »
Miscarriages and Pit Tumors:
Miscarriages can be prevented by measuring hormones: Study:
[Health India]: London, Nov 2 : Doctors would now be able to predict the risk of
a miscarriage in a woman by measuring their hormones, researchers at the
University College of London claim.
According to the BBC, researchers have found that women who have lower blood
level hormones produced by the placenta face a greater risk of having a
Professor Eric Jauniaux and his team, investigated whether this hormone and
others produced by the placenta might be useful markers of early pregnancy loss
and are now hopeful that by correcting the cause of these imbalances
miscarriages may be prevented.
"If we are able to identify these clear hormone variations early enough, we
believe there is a real window of hope for the development of preventative
therapies for these patients, "Professor Jauniaux was quoted as saying.
Researchers are also hoping that correcting these [hormonal] harmonical
imbalances may lead to the development of treatments to prevent recurrent
miscarriage as well. (ANI)
Grapefruit and Medications Alert
Although grapefruit is generally healthy and nutritious, the fruit has been shown to interact negatively with a variety of medications for treating heart disease, depression, seizures, and HIV. What is it about grapefruit that may be so dangerous?
Unlike other fruits, grapefruit contains chemicals that interfere with your body's ability to break down certain drugs. This can lead to undesirably high concentrations of the drug within your bloodstream and an increased risk of developing serious side effects. While it's not known what specifically causes this interaction, scientists do know that the chemical culprits are present in all parts of the grapefruit. Negative effects can also be experienced after taking dietary supplements made with grapefruit extract.
If you are on medication for high blood pressure, high cholesterol, depression, HIV, or seizures, consult your physician about the dangers associated with eating grapefruit. You may be instructed to eliminate grapefruit from your diet.
A New Indication for Norditropin® (somatropin rDNA
.c The Associated Press
Novo Nordisk's Human Growth Hormone Now Approved for Use in Adults
Novo Nordisk (NYSE: NVO) today announced that the Food and Drug Administration
(FDA) has approved the use of Norditropin@ (somatropin rDNA injection) in adults
with severe growth hormone deficiency. Norditropin was approved by the FDA in
1997 for use in children.
Today's action by the FDA makes it possible for children being treated with
Norditropin for growth hormone deficiency to continue their treatment into
adulthood, and also allows for the treatment of adults with conditions that
result in a deficiency of growth hormone. Earlier this year the FDA approved
Novo Nordisk's Norditropin NordiFlex@, the first prefilled, multidose,
disposable growth hormone pen in the United States.
"We are dedicated to meeting the needs of individuals who require growth hormone
therapy treatment,'' said Michael Shalmi, M.D., vice president of
biopharmaceuticals, Novo Nordisk Pharmaceuticals, Inc. "This approval by the FDA
is yet another step in Novo Nordisk's proud history of innovation in the field
of growth hormone therapy.''
Growth Hormone Deficiency in Adults
GH deficiency in adults is a clinical syndrome that usually results from a
pituitary or peri-pituitary tumor or as a direct result of the surgery or
radiation used to treat the tumor. GH deficiency also occurs from other
pituitary-related disease or from a deficiency in childhood(1). The prevalence
rate of adults with GH is approximately two in 10,000 of the adult population,
with adult-onset GH accounting for approximately one in 10,000(2).
Norditropin from Novo Nordisk is human growth hormone that has been
biosynthetically produced to resemble growth hormone the body makes naturally.
It is essentially identical to natural growth hormone in composition.
Novo Nordisk first produced biosynthetic growth hormone in 1985. In 1999, the
company introduced a liquid growth hormone formulation that did not require a
reconstitution or mixing procedure before injection. This was a major advance in
simplifying growth hormone therapy for patients.
Norditropin is indicated for the long-term treatment of children with growth
failure due to inadequate secretion of endogenous growth hormone and for
replacement of endogenous growth hormone in adults with growth hormone
deficiency (GHD) who meet either of the following two criteria: 1. Adult Onset
(AO): Patients who have GHD, either alone or associated with multiple hormone
deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic
disease, surgery, radiation therapy, or trauma; or 2. Childhood Onset (CO):
Patients who were growth hormone deficient during childhood should have GHD
confirmed as an adult before replacement therapy with Norditropin is started.
GHD should be confirmed by an appropriate GH stimulation test.
Norditropin should not be used in patients with known hypersensitivity to
somatropin or any of its excipients, in patients with proliferative or
preproliferative diabetic retinopathy. Growth hormone (GH) should not be used in
patients with active neoplasia and should be discontinued if evidence of
neoplasia develops. Growth hormone (GH) should not be used in pediatric patients
with closed epiphyses.
Increased mortality may occur in patients with acute critical illness due to
complications following open heart or abdominal surgery, multiple accidental
trauma or acute respiratory failure.
Deaths have been reported in patients with Prader-Willi syndrome who are
severely obese or have severe respiratory impairment. Male patients with one or
more of these factors may be at greater risk than females. Unless patients with
Prader-Willi syndrome also have a diagnosis of GHD, Norditropin is not indicated
for the long-term treatment of pediatric patients who have growth failure due to
genetically confirmed Prader-Willi syndrome.
Funduscopic examination of patients is recommended at the initiation and
periodically during the course of growth hormone therapy.
Monitor patients with GHD secondary to an intracranial lesion for progression or
recurrence of the underlying disease process. Monitor patients with glucose
intolerance closely; insulin dosage may need to be adjusted. Monitor carefully
if GH is administered in combination with other drugs metabolized by the CP450
pathway. Patients with coexisting ACTH deficiency should have their
glucocorticoid replacement dose carefully adjusted to avoid an inhibitory effect
on growth. Periodically monitor bone age in pediatric patients, especially in
patients who are pubertal and/or receiving concomitant thyroid hormone
Intracranial hypertension (IH) with papilledema, visual changes, headache,
nausea and/or vomiting has been reported in a small number of patients treated
with growth hormone products.
As with all protein drugs, a small percentage of patients may develop antibodies
to the protein. Since antibodies to somatropin have the potential to inhibit
further linear growth, only patients failing to respond to treatment should be
tested for antibodies.
The following adverse events have been reported during clinical studies in
growth hormone deficient children: headache, local reactions at the injection
site, localized muscle pain, rash, weakness, mild hyperglycemia, glucosuria and
arthralgia. Fluid retention and peripheral edema may occur.
In clinical studies with Norditropin in GHD adults the majority of side effects
were symptoms of fluid retention including peripheral edema, arthralgia, myalgia,
infection (non-viral) and parasthesia. In general, these side effects were mild
and transient in nature.
Full prescribing information for Norditropin@ and Norditropin NordiFlex@ is
available by contacting Novo Nordisk Pharmaceuticals, Inc. or visiting (http://www.norditropin.com)
Norditropin and Norditropin NordiFlex are registered trademarks of Novo Nordisk
Novo Nordisk is a healthcare company and a world leader in diabetes care. The
company has the broadest diabetes product portfolio in the industry, including
the most advanced products within the area of insulin delivery systems. In
addition, Novo Nordisk has a leading position within areas such as hemostasis
management, growth hormone therapy and hormone therapy for women. Novo Nordisk
manufactures and markets pharmaceutical products and services that make a
significant difference to patients, the medical profession and society. With
headquarters in Denmark, Novo Nordisk employs approximately 20,000 full-time
employees in 69 countries, and markets its products in 179 countries. Novo
Nordisk's B shares are listed on the stock exchanges in Copenhagen and London.
Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO.' For
more information, visit novonordisk.com, or in the US, (http://www.novonordisk-us.com)
(1) American Association of Clinical Endocrinologists medical guidelines for
clinical practice for growth hormone use in adults and children 2003 update.
Endocrine Practice. Vol 9 No. 1 January/February 2003.
(2) Bryan J, Loveman E, Chase D, Mihaylova B, Cave C, Gerard K, Milne R.
Clinical effectiveness and cost-effectiveness of growth hormone in adults in
relation to impact on quality of life: a systematic review and economic
evaluation. Health Technology Assessment NHS R&D HTA Programme. 2002; Vol.
For further information please contact: Media: Susan Jackson 609-919-7776
Investors: Christian Kanstrup 609-919-7937
Copyright © 2004 Market Wire
Distributed by the Associated Press
Merck Should Have Pulled Vioxx in 2000-Study
By Tom Armitage
BERNE (Reuters) - U.S. drugs giant Merck & Co Inc. should have pulled its Vioxx
painkiller from the market four years ago because data showing it raised the
risk of heart attacks has existed since 2000, Swiss scientists said on Friday.
In a report for British medical journal The Lancet, researchers at the
University of Berne said there was substantial evidence of the dangerous side
effects of the drug by the end of 2000, but the mounting data was not analyzed
"Our findings indicate that rofecoxib (Vioxx) should have been withdrawn several
years earlier," the scientists said.
Merck did not recall Vioxx, a COX-2 inhibitor taken by about 20 million
Americans, from the worldwide market until five weeks ago.
Merck said in a statement it "was vigilant in monitoring and disclosing the
cardiovascular safety of Vioxx and we absolutely disagree with any implication
to the contrary." The company said it also disagrees with the conclusion that
the drug should have been withdrawn several years ago.
"The company could and should have made the statement several years back, when
the data we analyzed were readily available," Matthias Egger, a professor at the
university's department for Social and Preventative Medicine, told a news
Merck said the data contained in the Swiss analysis are not new and are
essentially consistent with combined analyzes of clinical trials that the
company had previously published.
The Swiss research follows newspaper reports earlier this week that Merck had
tried to fight mounting concerns about the drug's safety in order to protect
The U.S. Food and Drug Administration recently published a study estimating that
Vioxx could have caused about 28,000 heart attacks or deaths since it was
approved in 1999.
Merck's shares have slumped around 40 percent since the recall, and analysts
estimate that it could face a bill of between $10 billion and $15 billion in
The Swiss scientists performed a meta-analysis on the data, taking in results
from past studies, some of which were available on the FDA Web site. They found
that patients who took Vioxx were at greater risk even after a few months,
regardless of how much of the drug was taken.
Using 18 randomized controlled trials and 11 observational studies, researchers
saw that heart-attack risk more than doubled when Vioxx was taken.
By the end of 2000, 52 heart attacks had occurred in 20,742 patients, the
researchers said. Of these, 41 were patients using Vioxx. The increased
heart-attack risks became apparent in studies that were evaluated by external
"It could be that without independent evaluation of the data, the assessment of
adverse effects is biased so that the risks of a drug appear smaller," Egger
"We therefore recommend that all studies be carried out with independent
external data evaluation."
Drug licensing authorities should review their procedures, the study concluded,
to ensure that data released after the drug launch is analyzed for signs of side
The authors also said an independent panel of experts should investigate why
manufacturers and licensing authorities did not evaluate the data available on
In an editorial in the journal, editor Richard Horton criticized both Merck and
the FDA, saying they acted out of "ruthless, short-sighted, and irresponsible
"The licensing of Vioxx and its continued use in the face of unambiguous
evidence of harm have been public-health catastrophes," said Horton.
"This controversy will not end with the drug's withdrawal."
Shares of Merck closed down 3 percent at $27.02 on the New York Stock Exchange
The study was part of a wider investigation into anti-inflammatory drugs and
their side effects conducted by the University of Berne on behalf of the Swiss
National Science Foundation. Full results are due mid-2006. (Additional
reporting by Deena Beasley in Los Angeles)
By AVA THOMAS BENSON, Associated Press
LITTLE ROCK - Arkansans especially at risk from
the flu — but who haven't been able to get a flu shot this year because of a
vaccine shortage — may get the protection they need from 80,000 more doses of
the flu vaccine being sent to the state.
The additional doses will be ready for distribution by next week, state
Health Department officials said Monday.
Arkansas originally received only 114,850 doses of the vaccine. Health
department officials sent 48,640 to nursing homes and the remaining 66,000 to
each of Arkansas 75 counties for distribution to the state's at-risk population,
estimated at more than 420,000. Clinics around the state began administering the
shots Wednesday, and officials said fewer than 4,000 of the original shots are
The state had asked the federal government for more doses of the vaccine, but
did not know if it would receive the doses.
"We just couldn't believe it," health department spokeswoman Ann Wright said.
"We thought we might get more vaccine, but 80,000 doses is just wonderful, great
news. We're just thrilled to death."
Wright said the additional vaccines would be sent to health clinics
throughout the state for distribution and that details of how the shots are
administered would likely be left to individual clinics. The department still
plans to restrict the shots to those in at-risk categories, she said.
"(The extra doses) are for people in the high-risk groups so they've got
protection. They can really go into complications from the flu and (Arkansas
receiving the extra shots) is such great news for them."
People in high risk categories include anyone 65 years of age or older,
children younger than 2 years old, pregnant women and people with certain
It takes about two weeks for immunity to develop after a person receives the
shot and the shot's effectiveness lasts for about three months.
The supply of flu vaccines was cut nearly in half this year when British
regulators stopped production at one of the two companies that provide the U.S.
with its vaccines. Officials said the flu vaccines produced at the
Liverpool-based Chiron Corp. had become contaminated.
Massachusetts Getting More Flu Vaccine
BOSTON - Massachusetts is getting more than
262,000 additional doses of flu vaccine, which state Public Health Commissioner
Christine C. Ferguson said should be enough to vaccinate people most at risk of
death or serious complications from the flu.
However she said healthy children older than 2 and healthy adults younger
than 75 will not yet be able to be vaccinated.
"What we don't know at this point is how many additional doses might be
available in the state over the course of the next month, month and a half, over
and above the 1.2 million that we are currently counting on," Ferguson said at a
news conference Monday.
Contamination concerns at a British plant wiped out nearly half the U.S.
The state Department of Public Health said it
will receive the additional 262,630 from Aventis Pasteur, the lone remaining
maker of vaccine for the U.S. market. That brings the state agency's total to
660,000, and roughly 600,000 flu shots have been shipped directly to doctors'
offices and hospitals by Aventis.
The new doses will be sent to local boards of health, doctors' offices and
Local boards of health placed their orders based on last year's demand, which
is estimated at less than half of those who were at high risk, health
"We're trying to meet a heightened demand, because a lot of people weren't
coming forward in previous years," Ferguson said.
Flu season typically peaks in January or February, and only one case in the
Greater Boston area so far has been reported.
Each year, about 800 Massachusetts residents die of complications from the
Your patients may qualify for research
studies in the Neuroendocrine Clinical Center, Massachusetts General
Hospital, Boston, MA 02114. We are currently accepting the following
categories of patients for screening to determine study eligibility.
Depending on the study, subjects may receive free testing, medication
preoperative medical treatments
acromegaly requiring medical therapy
different medical therapies
history of cured acromegaly and current hypopituitarism
GH effects in patients with history of cured acromegaly and GH
Dr. Anne Klibanski
hypopituitarism (panhypopituitary or partial hypopituitarism)
||Dr. Beverly M.K.
Dr. Karen K. Miller
||Dr. Karen K.
Dr. Anne Klibanski
with anorexia nervosa
density and the effects of estrogen replacement
||Dr. Anne Klibanski
Dr. Madhu Misra
hypopituitarism, ages 18-50
replacement therapy study
||Dr. Karen K.
|HIV positive women
with weight loss or fat redistribution
Evaluation of bone loss
Evaluation of cardiovascular risk markers
|HIV positive men
and women with fat redistribution
treatments to redistribute fat
Determination of growth hormone levels and efficacy of GH
Novel lipid lowering therapy
Dr. Colleen Hadigan
Dr. Polyxeni Koutkia
Dr. Roberto Salvatori at Johns Hopkins has received a large grant from NIH to study the
consequences of lack of growth hormone and it's affects on heart function, bone density, muscle strength, and fat metabolism. It is a wonderful study but he has run into a problem with a delay in
receiving the funding. It apparently had to go through the Brazilian Gov. which is where the study will take place in a population of dwarfs that genetically have no growth hormone (a perfect study sample).
Receipt of the funds may be delayed anywhere from three to six months.
The study began July 1 and an Endocrinology fellow, Dr. Danilo Fintini from Italy, was hired to do the research and begin July 12th, however there are no funds available yet to pay him. NIH grants require that the work be completed within a framework of time. To delay the project may cause a loss of the grant.
Any donation is tax deductible and greatly appreciated. $11,210 will be needed for the first three months and then another $11,210 for the next three months. This research when completed will help patients that are hypopituitary be treated with greater knowledge of the problem and insights in to how to help them recover strength, normal heart function and fat metabolism.
For more information about this study and Dr. Salvatori, in Word format:
please click here to download.
Thank you for your consideration in this matter. Please do not
hesitate to ask for more verification or information about the project. I look
forward to hearing from you soon.
We welcome your articles, letters to the editor, bios and
Cushing's information. Submit a Story or Article to
either the snailmail CUSH Newsletter or to an upcoming email
|To add or
edit your bio,
please click here »
Connie has steroid induced (iatrogenic) Cushing's brought on
by injections of DMSO and Kenalog
Izzy had Pituitary Surgery January 1, 2004 for a 15mm ACTH-producing
Jo Ellen V
room17teacher (Jo Ellen V) is scheduled for transphenoidal surgery the day
before Thanksgiving, 2004. She also has empty sella
Julie C is not yet diagnosed.
Marit is not yet diagnosed.
Merlenna is not yet diagnosed.
currently living in Dixon, California
but plans to move back to Hawaii
Sharon K was diagnosed with Cushing's disease in Nov. 2003 and pituitary
surgery on August 13th, 2004
• If you've been diagnosed with Cushing's, please
participate in the
Cushing's Register »
The information you provide will be used to create a register
and will be shared with the medical world. It would not be used
for other purposes without your expressed permission. Note:
This information will not be sold or shared with other
Lynne Clemens, Secretary of
CUSH Org is be the
person responsible for the creation of this register. If you
have any questions you may contact her at
do not have to be a member of CUSH to fill out this
questionnaire, as long as you are a Cushing’s patient. We do not
believe that the world has an accurate accounting of Cushing’s
patients. The only way to authenticate accuracy is with actual
numbers. Your help will be appreciated. Thank you."