Message from the
Director
Over the years, the FDA Office of Women's Health (OWH)
has sent periodic e-blasts to update our partners and stakeholders
on FDA actions and activities. This summer we are making some
changes to our electronic outreach as we work to find innovative
ways to provide you with timely information from OWH, FDA,
and HHS. The new look of this quarterly, online update reflects
these efforts. The new format provides snapshots of OWH
research and outreach initiatives below. To the left
you will also find links to OWH and FDA websites of interest
to health professionals, researchers, advocates, and community
leaders. We aim to connect you to the latest news on topics
from drug recalls and approvals to media outreach and public
meetings.
This e-update is only one example of new OWH initiatives.
This year we will begin new research initiatives from the OWH
Science Program and creative health education campaigns on
health fraud and drug safety from the Take Time To Care program. So,
read this update and look out for e-blasts of breaking news
regarding FDA safety efforts and initiatives of particular
interest to women.
Kathleen Uhl, MD
Assistant Commissioner for Women's Health
OWH Research
The OWH Science Program continues its commitment to fund FDA
research that examines gender differences. In May, OWH announced
its FY 2006 funding awards. We congratulate the FDA scientists
listed below for their outstanding submissions and look forward
to learning more from them about their research. Check the
OWH Web site for future updates about research findings and
publications from OWH funded studies.
Six projects will be funded through the OWH Intramural Science
Program:
- Hanna Golding - CBER
HIV SELECTEST: A novel assay for diagnosis of HIV infections
in the presence of antibodies induced by candidate HIV vaccines
-- Evaluation of gender bias in sensitivity and specificity
- Ohidul Siddiqui -- CDER
Statistical analyses of gender-specific data from New Drug
Application (NDA) submissions.
- Leslie Kenna -- CDER
Quantitative Tumor Size -- Survival relationship in oncology
clinical trials.
- Azadeh Shoaibi & Dale Tavris --
CDRH
Assessment of the accuracy of the Troponin Assay in the diagnosis
of myocardial infarction by gender/ How gender influences
treatment.
- Varsha Desai -- NCTR
Molecular mechanisms underlying gender-associated differences
in the adverse reactions to the anti-retroviral agent, zidovudine
(AZT): Role of mitochondrial toxicity.
- Ying Huang -- NCTR
Sex differences in chemotherapeutic toxicity: Profiling of
transporter genes in humans.
In addition to the above awards, OWH will provide funds for
several Special Funding Initiatives Grants.
- Christopher Elkins, Ph.D. and Mark Hart, Ph.D. - NCTR
Protective effect of vaginal Lactobacillus species against
Staphylococcus aureus-mediated toxic shock syndrome
- Kara Morgan, Ph.D. - OC
Evaluation of How Best to Communicate to Health Care Providers
about the Risks and Benefits of Prescription Drug Use for
Pregnant and Nursing Women
- OWH and CDER Collaboration/ Mary Willy, Ph.D. - CDER
Drug Use in Pregnancy
Demographic Data Initiative
OWH instituted the "Inclusion
of Women in Clinical Trials Initiative" to support research
by FDA investigators to track the inclusion of women in clinical
trials and to monitor sex analyses submitted in market applications.
In May, five projects were selected for funding under this
new initiative:
- Angela Men -- CDER
Impact of Gender and Pharmacogenomics on Clinical Efficacy,
Safety and Pharmacokinetics of Drugs Used for the Treatment
of Alzheimer's Disease
- Greg Soon -- CDER
Women in HIV Trials: A comprehensive review and meta-analysis
- Shasi Amur -- CDER
Gender differences and impact of Pharmacogenomics in Rheumatoid
Arthritis
- Yongsheng Yang -- CDER
Participation of women in clinical trials and gender analysis
of data in original NDAs approved 2000-2004
- Kathryn O'Callaghan -- CDRH
Evaluation of availability and quality of information available
on females included in mechanical heart device implant trials
Outreach Initiatives
The Office of Women's Health is expanding its efforts
to reach women in both rural and urban communities nationwide
who may not have access to easy-to-read health education materials.
During
Women's Health Week in May, OWH collaborated with Parade
Magazine and the "Hints
from Heloise" syndicated
column to announce the availability of free "Women's
Health Kits". The kits contain OWH fact sheets and brochures
on topics ranging from heart disease and depression to asthma
and sleep disorders. Women were directed to call 1-888-8PUEBLO
or visit the website of the Federal Citizen Information Center
(FCIC) to have the kits mailed to them. The announcement in
Parade Magazine ran on Mother's Day while the "Hints
for Heloise" column was published in papers nationwide
during the week of May 14-20. To date, over 1
million publications
have been distributed through the Heloise campaign and 500,000 through Parade.
In addition to these media efforts, OWH reached
out to public libraries, particularly those in communities
impacted by the recent hurricanes. Recognizing that public
libraries are a trusted source of information for many women,
OWH lifted restrictions on the number of free OWH publications
librarians could order to distribute to women in their communities.
From March through June, librarians could place bulk orders
for materials through FCIC by visiting:
http://www.pueblo.gsa.gov/rc/library_p15.htm
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OWH and NACHC collaborate to reach nearly 500,000 women
As a part of the Menopause Hormone Therapy (MHT) Initiative,
OWH joined forces with the National Association of Community
Health Centers (NACHC) to distribute OWH MHT materials to the
low income and minority women who use community health centers
(CHC) nationwide. According to NACHC, approximately 91% of
CHC patients are low income; 40% are uninsured; 36% depend
on Medicaid; and approximately 63.5% are members of racial
and ethnic minority groups. Approximately 50% of all
CHC patients reside in rural areas and the other half live
in economically depressed inner city communities.
Phase I of the collaboration targeted 900 community health
centers and 3500 of their respective sites. The targeted CHCs
received a NACHC-developed marketing tool that included samples
of OWH materials and an order form. During Phase I, 282,500 English fact sheets and 180,000 Spanish fact sheets were distributed
in 47 states and territories. In addition, 180,000 Spanish
and 241,000 English purse-sized, MHT question guides were distributed.
OWH looks forward to another successful collaboration with
NACHC as we begin the second phase.
Hot Topics
FDA Advisory Committee Endorses Cervical Cancer Vaccine
On
May 18, 2006, the FDA Center for Biologics Evaluation and Research
(CBER) Vaccines and Related Products Advisory Committee unanimously
endorsed the approval of Gardasil R, a vaccine for human papilloma
virus (HPV) types 6, 11, 16, and 18. The vaccine has not yet
been approved by the FDA. [Note: Since this Update was published,
Gardasil was approved by FDA. For updated information read
the June 8,
2006, Press Release.]
This vaccine
is intended for the prevention of cervical cancer and genital
warts, as well as vulvar and vaginal precancers related to
HPV types 6, 11, 16, and 18. It is a recombinant type of
vaccine made from a protein from the outer coat of each of
the four types of HPV. The vaccine cannot cause an infection.
The vaccine will need to be given as a sequence of three
shots. It appears to be most effective in women who have
not had a prior HPV infection. Even after receiving this
vaccine, women will also need cervical cancer screening with
pap smears and other technologies and procedures.
About 70% of cervical cancer is associated with HPV types 16
and 18. Condyloma accuminata, commonly referred as genital
warts, are associated with HPV types 6 and 11.
To learn more
about cervical cancer visit the National Cancer Institute Web
site at:
http://www.cancer.gov/cancertopics/types/cervical/
For more information on FDA Advisory Committee Meetings visit: http://www.fda.gov/oc/advisory/default.htm
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OWH and ORWH develop New Online Course
OWH collaborated with the NIH Office of Research on Women's
Health (ORWH) to develop an online course entitled "The
Science of Sex and Gender in Human Health." The course
provides information on: the major physiological differences
between the sexes, their influence on illness and health outcomes,
and their policy, research and treatment implications. This
free course is self-paced and consists of six lessons. Following
successful completion of the course, participants will receive
Continuing Medical Education (CME) credit and/or a certificate
from NIH.
The course is accessible at http://orwh.od.nih.gov.
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Reports from the Field
FDA Public Affairs Specialists help to spread the word about
OWH publications and activities. The following are a sample
of recent activities.
Natalie Guidr participated in the 50th Anniversary Celebration
of the Alabama Public Health Association on May 3rd in Birmingham,
AL.
Sandra Baxter provided OWH publications and information at
the Spirituality and Women's Health Issues Conference
at Antioch Baptist Church in Boutte, LA on May 3rd.
Sheryl McConnell attended the 2nd Annual Health Fair in observation
of National Women's Health week and National Women's Check-Up
day.
JoAnn Pittman was invited to participate in the International
Conference on Women and Infectious Diseases in Atlanta.
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