What's New?

November 10, 2004
To read the archives, please click here.

In This Issue: Happenings Site News Meetings Chat Info

Webcast from the Free Pituitary Symposium at NIH, October 29
Webcast ENDO 2004
Young Sam on Discovery Health show, "Mystery Diagnosis" Monday night
Miscarriages and Pituitary Tumors
Grapefruit and Medications Alert
A New Indication for Norditropin® (somatropin rDNA injection)
More on Vioxx
Arkansas and Massachusetts to Receive More Flu Vaccine
Upcoming Meetings in California and Florida; Local Meetings
Four new bios, three updated bios.
Read all about them below.


Next Online Newsletter will be Wednesday, November 17
read archived issues here »

December 4, 2004, UCLA Pituitary and Neuroendocrine Program and Harbor-UCLA Pituitary Center present a Second California Pituitary Conference in Beverly Hills, CA. More info and registration here »

January 28, 2005, Pituitary Update Conference For Patients And Physicians. More info here.

More upcoming local meetings are listed here »

Sign up for notification of local meetings. You need not be a CUSH member to participate.

News!

Webcast from NIH Office of Research on Women's Health
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 many ramifications.

Speakers included:

  • 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.
    Deputy Director
    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
    Pathologist-in-Chief
    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
    Chief, Endocrinology
    National Center for Complimentary and Alternative Medicine

  • A Young Woman's Hormonal World
    James Segars, M.D.
    Staff Clinician
    National Institute of Child Health and Human Development

  • Hormonal Needs and Disorders in the Mature Female
    Janet A. Schlecte, M.D.
    Endocrinologist
    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:

http://news.newkerala.com/india-news/?action=fullnews&id=40422

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 miscarriage.

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 injection)

.c The Associated Press

Novo Nordisk's Human Growth Hormone Now Approved for Use in Adults

PRINCETON, NJ

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).

About Norditropin

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 replacement therapy.

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) www.norditropin.com.

Norditropin and Norditropin NordiFlex are registered trademarks of Novo Nordisk A/S.

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) 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. 6:No.19

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


http://story.news.yahoo.com/news?tmpl=story&cid=594&e=1&u=/nm/20041105/hl_nm/health_merck_vioxx_dc

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 properly.

"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 conference.

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 sales.

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 litigation.

INDEPENDENT EVALUATION

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 watchdogs.

"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 said.

"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 effects.

The authors also said an independent panel of experts should investigate why manufacturers and licensing authorities did not evaluate the data available on Vioxx sooner.

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 self interest."

"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 on Thursday.

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)


http://story.news.yahoo.com/news?tmpl=story&cid=534&e=5&u=/ap/20041109/ap_on_he_me/flu_shots_ark

Arkansas Receives More Flu Vaccine

By AVA THOMAS BENSON, Associated Press Writer

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 left.

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 medical conditions.

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.



http://story.news.yahoo.com/news?tmpl=story&cid=534&e=4&u=/ap/20041109/ap_on_he_me/flu_vaccine_mass

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. supply.

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 hospitals.

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 authorities said.

"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 flu.


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 and/or stipends.

SUBJECTS
STUDIES
CONTACT
617-726-3870
Newly diagnosed acromegaly patients
 
Evaluating preoperative medical treatments
 
Dr. Laurence Katznelson
Patients with acromegaly requiring medical therapy
 
Evaluating two different medical therapies Karen Szczesiul, R.N.
Patients with history of cured acromegaly and current hypopituitarism Investigating GH effects in patients with history of cured acromegaly and GH deficiency Dr. Catherine Beauregard
Dr. Anne Klibanski
Patients with hypopituitarism (panhypopituitary or partial hypopituitarism)
 
GH deficiency/replacement studies Dr. Beverly M.K. Biller
Dr. Karen K. Miller
Women with anorexia nervosa New hormonal therapies Dr. Karen K. Miller
Dr. Anne Klibanski
Adolescent girls with anorexia nervosa
 
Evaluating bone density and the effects of estrogen replacement Dr. Anne Klibanski
Dr. Madhu Misra
Women with hypopituitarism, ages 18-50
 
Testosterone replacement therapy study Dr. Karen K. Miller
HIV positive women with weight loss or fat redistribution Evaluating testosterone therapy

Evaluation of bone loss

Evaluation of cardiovascular risk markers
Dr. Steven Grinspoon
HIV positive men and women with fat redistribution Novel treatments to redistribute fat

Determination of growth hormone levels and efficacy of GH secretogogues

Novel lipid lowering therapy
Dr. Steven Grinspoon
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 newsletter at
http://www.cushings-help.com/newsletter_story.htm

Newest Bios:
To add or edit your bio, please click here »
Connie Connie has steroid induced (iatrogenic) Cushing's brought on by injections of DMSO and Kenalog Richmond, VA
Izzy Updated
Izzy had Pituitary Surgery January 1, 2004 for a 15mm ACTH-producing Macroadenoma
Woodside, NY
Jo Ellen V (room17teacher )  Updated
room17teacher (Jo Ellen V) is scheduled for transphenoidal surgery the day before Thanksgiving, 2004. She also has empty sella
 Indianapolis, IN
Julie C Julie C is not yet diagnosed. Indiana
Marit Marit is not yet diagnosed. Saskatoon, Canada
Merlenna H Merlenna is not yet diagnosed. currently living in Dixon, California
but plans to move back to Hawaii
Sharon K Updated
Sharon K was diagnosed with Cushing's disease in Nov. 2003 and pituitary surgery on August 13th, 2004
Austin, Texas


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