esterified estrogens and methyltestosterone, Estratest, Estratest HS

Notice: Solvay Pharmaceuticals, Inc. announced on March 10, 2009, that it would discontinue supplying the marketplace with ESTRATEST® (Esterified Estrogens and Methyltestosterone) Tablets and ESTRATEST® HS (Esterified Estrogens and Methyltestosterone) Tablets. Effective March 31, 2009, the company will no longer accept orders for new product from its customers.

GENERIC NAME: esterified estrogens and methyltestosterone

BRAND NAME: Estratest

DRUG CLASS AND MECHANISM: Esterified estrogens are a mixture of related estrogens. Estrogens, when taken alone or in combination with a progestin, have been shown to reduce the risk for hip fracture due toosteoporosis by 25% as well as the risk of heart attack (myocardial infarction) and stroke by 40-50%. Esterified estrogens are used for numerous medical situations. Estrogens cause growth and development of female sex organs and the maintain sex characteristics, including growth of underarm and pubic hair and shaping of body contours and skeleton. Estrogens also increase secretions from the cervix and growth of the inner lining of the uterus (endometrium). Estrogens reduce LDL-cholesterol ("bad"cholesterol) and increase HDL-cholesterol ("good" cholesterol) concentrations.

Testosterone is the major male sex hormone that is responsible for many male sexual characteristics, but women also produce small amounts of testosterone. Following menopause, a woman's production of testosterone decreases. When testosterone in the form of methyltestosterone is added to estrogens, there may be a further alleviation of the hot flashes seen aftermenopause, and there also may be an improvement in a woman's sexual function.

GENERIC AVAILABLE: no

PRESCRIPTION: yes

PREPARATIONS: Estratest tablets: esterified estrogens 0.625mg plus methyltestosterone 1.25mg; esterified estrogens 1.25mg plus methyltestosterone 2.5mg. Estratest HS is one-half the strength of Estratest.

STORAGE: Tablets should be stored at 36-86°F (20-30°C).

PRESCRIBED FOR: Estratest is prescribed for the treatment of the common symptoms associated with menopause (e.g., hot flashes, vaginal dryness).

DOSING: Estratest usually is prescribed as 1 or 2 tablets daily for 21 consecutive days followed by 7 days without medication.

DRUG INTERACTIONS: For drug interactions for esterified estrogens, please read the esterified estrogens article.

Methyltestosterone can increase the effects of warfarin (Coumadin), increasing the risk of bleeding. Taking methyltestosterone and imipramine(Tofranil) together has led to paranoia in a few patients. Methyltestosterone can increase blood concentrations of cyclosporine (Sandimmune; Neoral), which can increase the risk of kidney damage.

PREGNANCY: Both methyltestosterone and estrogens should not be used during pregnancy due to an increased risk of fetal abnormalities.

NURSING MOTHERS: Estrogens are secreted in milk and cause unpredictable effects in the infant. They should not be used during breast-feeding.

SIDE EFFECTS: For side effects, please read the esterified estrogensarticle.

Methyltestosterone can have masculinizing effects in women, the development of acne, growth of facial hair, enlargement of the clitoris, reduction in breast size, and deepening of the voice. If treatment is discontinued when these symptoms first appear, they usually diminish or disappear; however, prolonged treatment can cause irreversible masculinizing effects.

Reference: FDA Prescribing Information

أسرار صداع الشقيقة الاسباب العلاج النهائي الطبيعي الغذاء الميزان

كيف تفسر الصداع الذي يرافقه شعور بالتقيؤ؟ 

الجواب هذا على الأغلب هو صداع الشقيقة , وبنبذة بسيطة عن صداع الشقيقة نستطيع أن نقول أن صداع الشقيقة هو نوع من أنواع التحسس وذلك لارتباطه بما يعرف باسم البنية الحرضية التحسسية عند الإنسان , فقد وجد أن الناس الذين عندهم هذه البنية الحرضية التحسسية يصابون بخمسة أمراض هي الإكزيما والأرتكاريا وحمى القش ( حساسية الأنف والعيون ) والربو والشقيقة , وقد لاحظ العلماء أن واحدا من هذه الأمراض إذا ظهر عند فرد من العائلة فعلى الأغلب أن يكون هناك شخص آخر في نفس العائلة يعاني من مرض آخر في هذه المجموعة , يتميز صداع الشقيقة بحدوث انطلاق بعض المواد الكيميائية التي يعتقد أنها تنطلق بسبب التحسس الذي يشتد في فترة تحول الطقس مثل قدوم الربيع أو قدوم الخريف أو حتى تناول بعض الأطعمة أو الاضطراب الهرموني كما يحدث قبل الدورة الشهرية عند النساء , هذه المواد تسبب توسعا في الأوعية الدموية ثم تضيقا ثم توسعا , ولذلك فالشقيقة تعرف باسم الصداع الوعائي لأنه يحدث عملية التهابية في الأوعية الدموية , ويتميز ألمها بأن ينبض مثل النبض تماما وليس شرطا أن يكون صداع الشقيقة في نصف الرأس فقد يكون في الرأس كله , وقد يكون نصفيا بين اليمين واليسار أو الأعلى والأسفل أو الأمام والخلف من الرأس ولعل أهم ما يميز صداع الشقيقة ما يعرف باسم النسمة , فتضيق الأوعية في منطقة دماغية معينة سيؤثر على هذه المنطقة وعلى وظيفتها مما يجعل المريض قادرا على التنبؤ ببدء حدوث الصداع وذلك بسبب تاثر المنطقة الدماغية التي تبدأ بها هجمة تضيق الأوعية , حيث قد يشم رائحة غريبة إذا كان تضيق الأوعية في منطقة الشم , أو يسمع صوت طنين أو تشويش إذا كان التشنج في منطقة السمع أو يصاب بتشوش في الرؤية إذا كان تضيق الأوعية في منطقة البصر أو شعور غريب حسب المنطقة التي يتضيق فيها الوعاء , ومن أعراض الشقيقة المميزة وجود أعراض الإقياء المترافقة معها إذا عادة ما يكون الإقياء مخففا لهجمة صداع الشقيقة وبعض الناس التي تكون لديهم أعراض الشقيقة شديدة جدا يتعمدون الإقياء بوضع أصبعهم في حلقهم حتى يخفف ذلك عنهم , ونقول لهم كان الله في عونكم , ونستخدم بنجاح باهر ومذهل وبتوفيق من الله مجموعة الصداع عندنا والتي تغطي كل آلية من آليات صداع الشقيقة المعروفة وكل مادة كيميائية تنطلق تؤثر على الأوعية الدموية وتسبب تقبضها أو توسعها فنحن هنا نريد أن نصيب الداء كما أخبر رسول الله صلى الله عليه وسلم " فإذا أصيب دواء الداء برأ بإذن الله " رواه مسلم ومجموعتنا للتخلص من صداع الشقيقة تشمل زيت وخل إكليل الجبل والخزامى والزنجبيل والميرمية والبابونج شربا ودهنا , حيث يلاحظ المريض الذي يستخدم المنتجات أن الهجمات تصبح أقل عددا وأقصر مدة وأقل كثافة إلى أن نصل إلى مرحلة بعد 4 أو 5 شهور تختفي الهجمات نهائية , وقد لاحظنا أيضا أن استخدام خليط الزيوت لخلاصات الأعشاب السابقة , واستخدامه دهنا في منطقة الجبهة ومن ثم إلى كل الراس عند بداية الصداع , يؤدي إلى إحباط الهجمة وزوالها بشكل نهائي دون استخدام أدوية أو حقن مثل حقن الفولترين أو البروفين او غيرها ويمكن الحصول على منتجاتنا من موزعينا الموجودين في كافة أنحاء العالم بإذن الله

ARIZONA MESOTHELIOMA LAWYERS

The mesothelioma lawyers at the Simmons Law Firm represent victims of mesothelioma cancer throughout the United States including the state of Arizona. We have represented thousands of families affected by mesothelioma and asbestos-related lung cancer and have seen the suffering it causes firsthand. The Simmons Law Firm is dedicated to giving our clients the respect and attention they deserve, no matter where they live.

If you or someone you love has mesothelioma, we will come to you. Over the past decade, we’ve represented many clients throughout Arizona, including families from the following locations:

• Gilbert
• Hayden
• Phoenix
• Prescott
• Scottsdale
• Skull Valley
• Tempe
• Tucson
• Youngstown

As a nationwide firm, our asbestos attorneys have the resources and experience necessary to represent individuals and families against large companies in this complex area of litigation. Our firm has recovered over $4 billion in verdicts and settlements for thousands of families affected by mesothelioma and asbestos-related diseases. Our asbestos attorneys have recovered $130 million on behalf of mesothelioma and asbestos-related victims in the state of Arizona alone.*

* Please note that recovery results vary per client. The recovery amounts in each case reflect the specific facts of that case. Further, recovery amounts in past cases are not a guarantee of future results

You should know that Arizona has a unique set of laws that could impact your ability to file a claim. For example, Arizona has statute of limitation laws that restrict the time frame in which mesothelioma victims and family members can file a lawsuit. Rest assured our mesothelioma lawyers are prepared to help you understand the process for filing an asbestos lawsuit and guide you through the legal system. Contact the Simmons Law Firm if you have a question about a potential case.

If you have mesothelioma or lung cancer due to asbestos exposure, please contact our mesothelioma lawyers for a free case evaluation.

AN INTRODUCTION TO ASBESTOS AND MESOTHELIOMA

Asbestos is a deadly mineral that has been used in thousands of products. When microscopic asbestos fibers are inhaled or ingested, they can cause a number of diseases, including mesothelioma and lung cancer. Of the diseases caused by asbestos, mesothelioma is the most aggressive, attacking the internal lining of the lungs and abdomen. Mesothelioma typically does not develop until decades after the asbestos exposure occurred.

The following is a partial list of Arizona job sites and buildings that may have contained asbestos.  This list does not necessarily reflect current conditions.  If you are experiencing symptoms related to asbestos exposure, please consult with a physician. 

Chandler
Chandler Power Plant

Flagstaff
Southwest Forest

Glendale
Aqua Fria Powerhouse

Phoenix
Phoenix Civic Plaza
Good Samaritan Hospital
Valley Bank Building
Arizona Bank

Tempe
Kyrene Powerhouse
Arizona Public Service Plant

Tucson
University Of Arizona
Tucson Gas & Electric Company

View additional work sites in Arizona.

If you or a loved one has suffered from an asbestos-related disease, please contact us today for a free legal consultation.

LEARN MORE ABOUT MESOTHELIOMA:

» Types of Mesothelioma

» Mesothelioma Diagnosis Information

» Filing a Mesothelioma Lawsuit

» Contact Asbestos Lawyers

The majority of individuals who have been exposed to asbestos encounter the so-called "magic mineral" in their line of work, often due to inadequate safety precautions. Others are exposed to asbestos indirectly when they come in contact with the clothing of a family member involved in a high-risk asbestos occupation.

Asbestos has been widely used in many industrial products including cement, brake linings, roof shingles, flooring products, textiles, and insulation. When microscopic asbestos dust particles becomes airborne, they can be inhaled or swallowed and can cause serious health issues.

Common work environments where a mesothelioma or cancer patient may have encountered asbestos include shipyards, oil refineries, sheet metal plants, automotive plants, construction sites, and many more. Here is a complete list of occupations that have been linked to asbestos exposure.

GIVING BACK TO MESOTHELIOMA PATIENTS & FAMILIES

In 2010, the Simmons Law Firm established the Simmons Mesothelioma Foundation, a private, non-profit organization dedicated to supporting research and advancing awareness about this rare cancer. The Foundation partners with established experts and thought-leaders in the mesothelioma research field. Learn more about the Foundation's current mesothelioma research partners.

As a long-time supporter of the Mesothelioma Applied Research Foundation and the Asbestos Disease Awareness Organization, the Simmons Law Firm has an extensive history of supporting the fight against mesothelioma and cancer. The firm has also pledged over $10 million to establish the Simmons Cancer Institute at the Southern Illinois University School of Medicine. The institute provides extraordinary new resources to enhance treatments and implement the continuing search for a permanent cure. It is the largest single gift in the history of SIU and establishes the university as home to one of the leading cancer facilities in the United States.

ASBESTOS EXPOSURE IN ARIZONA TODAY

Asbestos has not yet been banned in the United States. Its use is regulated, but it is still used in products today. Asbestos has been classified by the International Agency for Research on Cancer as a human carcinogen. This assessment is supported by the International Labor Organization (ILO) and the World Health Organization (WHO), both of which believe that the future use of asbestos should be banned.

For more information about asbestos in Arizona and throughout the U.S., visit theEnvironmental Protection Agency's website.

Diabetes and Mental Health | CDC

Diabetes and Mental Health | CDC

Diabetes and Mental Health

Español (Spanish)

Is mental health pretty low on your list of priorities for managing diabetes? This may change your mind.
Mental health affects so many aspects of daily life—how you think and feel, handle stress, relate to others, and make choices. You can see how having a mental health problem could make it harder to stick to your diabetes care plan.

The Mind-Body Connection

Thoughts, feelings, beliefs, and attitudes can affect how healthy your body is. Untreated mental health issues can make diabetes worse, and problems with diabetes can make mental health issues worse. But fortunately if one gets better, the other tends to get better, too.

Labeling Updates: Neural Tube Defects

Dolutegravir and risk of neural tube defects: Labeling Updates

FDA recently approved changes to the TIVICAY (dolutegravir), TRIUMEQ (abacavir, dolutegravir, and lamivudine, JULUCA (dolutegravir and rilpivirine) and DOVATO (dolutegravir and lamivudine) labeling to include updated information regarding the risk of neural tube defects with dolutegravir based on the final results from Tsepamo Study. Similar changes were made to all four labels. A summary of the changes to the Tivicay label are included below.

Section 5 WARNINGS AND PRECAUTIONS

5.3         Embryo-Fetal Toxicity

An observational study showed an association between TIVICAY and an increased risk of neural tube defects when TIVICAY was administered at the time of conception and in early pregnancy. As there is limited understanding of reported types of neural tube defects associated with dolutegravir use and because the date of conception may not be determined with precision, an alternative treatment to TIVICAY should be considered at the time of conception through the first trimester of pregnancy.

Perform pregnancy testing before initiation of TIVICAY in adolescents and adults of childbearing potential to exclude use of TIVICAY during the first trimester of pregnancy [see Dosage and Administration (2.1)]. Initiation of TIVICAY is not recommended in adolescents and adults actively trying to become pregnant unless there is no suitable alternative.

Counsel adolescents and adults of childbearing potential to consistently use effective contraception.

In adolescents and adults of childbearing potential currently on TIVICAY who are actively trying to become pregnant, or if pregnancy is confirmed in the first trimester, assess the risks and benefits of continuing TIVICAY versus switching to another antiretroviral regimen and consider switching to an alternative regimen.

TIVICAY may be considered during the second and third trimesters of pregnancy if the expected benefit justifies the potential risk to the pregnant woman and the fetus.

Section 8: USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Data from a birth outcome surveillance study has identified an increased risk of neural tube defects when TIVICAY is administered at the time of conception compared with non-dolutegravir-containing antiretroviral regimens. As defects related to closure of the neural tube occur from conception through the first 6 weeks of gestation, embryos exposed to dolutegravir from the time of conception through the first 6 weeks of gestation are at potential risk. In addition, 2 of the 5 birth defects (encephalocele and iniencephaly), which have been observed with dolutegravir use, although often termed neural tube defects, may occur post-neural tube closure, the time period of which may be later than 6 weeks of gestation, but within the first trimester. Due to the limited understanding of the types of reported neural tube defects associated with dolutegravir use and because the date of conception may not be determined with precision, an alternative treatment to TIVICAY should be considered at the time of conception through the first trimester of pregnancy. Initiation of TIVICAY is not recommended in adolescents and adults actively trying to become pregnant unless there is no suitable alternative (see Data).

In adolescents and adults of childbearing potential currently on TIVICAY who are actively trying to become pregnant, or if pregnancy is confirmed in the first trimester, assess the risks and benefits of continuing TIVICAY versus switching to another antiretroviral regimen and consider switching to an alternative regimen. Advise pregnant adolescents and adults of the potential risk to the embryo exposed to TIVICAY from the time of conception through the first trimester of pregnancy. A benefit-risk assessment should consider factors such as feasibility of switching, tolerability, ability to maintain viral suppression, and risk of transmission to the infant against the risk of neural tube defects.

There are insufficient human data on the use of TIVICAY during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. The background risk for major birth defects for the indicated population is unknown. In the U.S. general population, the estimated background rate for major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

In animal reproduction studies, no evidence of adverse developmental outcomes was observed with dolutegravir at systemic exposures (AUC) less than (rabbits) and approximately 27 times (rats) the exposure in humans at the maximum recommended human dose (MRHD) of TIVICAY (see Data).

Data

Human Data: In a birth outcome surveillance study in Botswana, there were 5 cases of neural tube defects reported out of 1,683 deliveries (0.3%) to women who were exposed to dolutegravir-containing regimens at the time of conception. In comparison, the neural tube defect prevalence rates were 0.1% (15/14,792 deliveries) in the non-dolutegravir arm and 0.08% (70/89,372 deliveries) in the HIV-uninfected arm. Five cases reported with dolutegravir included one case each of encephalocele, anencephaly, and iniencephaly, and 2 cases of myelomeningocele. In the same study, one infant out of 3,840 (0.03%) deliveries to women who started dolutegravir during pregnancy had a neural tube defect, compared with 3 infants out of 5,952 (0.05%) deliveries to women who started non-dolutegravir-containing regimens during pregnancy.

Data analyzed to date from other sources including the APR, clinical trials, and postmarketing data are insufficient to address the risk of neural tube defects with dolutegravir.

Data from the birth outcome surveillance study described above and postmarketing sources with more than 1,000 pregnancy outcomes from second and third trimester exposure in pregnant women indicate no evidence of increased risk of adverse birth outcomes.

The updated labels will soon be available at Drugs@FDA or DailyMed

Kimberly Struble

Division of Antiviral Products

Food and Drug Administration

Elizabeth Thompson

Division of Antiviral Products

Food and Drug Administration

Michael Stanfield Jr.

Division of Antiviral Products

Food and Drug Administration

MedlinePlus Twitter Update

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@HHSGov

: #DYK? In 2018, most misused prescription drugs were obtained from family and friends. Join

@DEAHQ

tomorrow during National Pres…

FDA Public Workshop: Clinical Pharmacology in Drug Development for Liver Diseases

FDA Announces Public Workshop on Clinical Pharmacology in Drug Development for Nonalcoholic Steatohepatitis (NASH) and Cholestatic Liver Diseases on December 9, 2019

The U.S. Food and Drug Administration (FDA), in collaboration with the Duke Margolis Center for Health Policy, will host a public workshop entitled “Leveraging Clinical Pharmacology to Optimize Drug Development for Nonalcoholic Steatohepatitis (NASH) and Cholestatic Liver Diseases” on December 9, 2019.

There is significant unmet medical need in the prevention and treatment of nonalcoholic steatohepatitis (NASH), primary biliary cholangitis, and primary sclerosing cholangitis. Despite its increasing prevalence and potential to cause severe liver-related morbidity (including liver cancer) and mortality, there are currently no drugs approved for the treatment of NASH. Recognizing that the complex etiologies, natural histories, and pathophysiologies of NASH and other cholestatic liver diseases are major impediments to ongoing drug development, the FDA released two draft guidances to assist industry in the clinical development of drugs for the treatment of NASH with liver fibrosis (https://go.usa.gov/xpqsX) and with compensated cirrhosis (https://go.usa.gov/xpqsN).

To further assist in drug development for NASH and cholestatic liver disease indications, FDA and Duke-Margolis are convening this public meeting to discuss clinical pharmacology-driven considerations and approaches to optimize drug safety and efficacy for these indications. Discussion will encompass:

• The impact of liver dysfunction on drug pharmacokinetics, pharmacodynamics, patient safety and patient outcomes;
• Emerging biomarkers, including non-invasive biomarkers, and their utility in the early-phase development of drugs for NASH and cholestatic liver disease;
• Challenges associated with optimizing clinical trial design, including adequate characterization of pharmacologic effect, selection of study population, and bridging of trial endpoints to clinical meaningfulness; and
• Clinical pharmacology approaches for optimizing drug development programs as well as the safety and efficacy of new drugs.

The date, time, location, and other details of the workshop are as follows:

Date: December 9, 2019

Time: 9:00 am to 4:45 pm

Location: Sheraton Silver Spring Hotel (Magnolia Ballroom), 8777 Georgia Avenue, Silver Spring, Maryland 20910

Persons interested in attending this public workshop in-person or via webcast can register online at https://events.r20.constantcontact.com/register/eventReg?oeidk=a07egnu5br5a1b5f0d9&oseq=&c=&ch=. Registration for this public workshop is free.

For further information, contact: Duke-Margolis Events, Duke-Robert J. Margolis, MD, Center for Health Policy, margolisevents@duke.edu.

Elder Abuse

Elder Abuse

RT

@Alzheimers_NIH

: Elder abuse can include physical or emotional abuse, neglect, and even financial exploitation. Learn about how to spot the signs to protect your older family member or friend. https://bit.ly/2hYaUWb

NIH ADEAR Center (@Alzheimers_NIH) / Twitter

NIH ADEAR Center (@Alzheimers_NIH) / Twitter

RT

@Alzheimers_NIH

: DYK some changes in thinking, such as difficulty multi-tasking, are common as you get older? Learn more about common changes in the aging brain and how they may affect thinking.

Obesity Screening: MedlinePlus Lab Test Information

Obesity Screening: MedlinePlus Lab Test Information

An obesity screening is used to find out if you or your child is at an unhealthy weight. The screening may include:
- A measurement called a #BodyMassIndex (BMI)
- A physical exam
- A measurement around your waist
- Blood tests
Learn more: http://ow.ly/lZmf50wSv4n

NIH Launches New Collaboration to Develop Gene-Based Cures for Sickle Cell Disease and HIV on Global Scale | HIV.gov

NIH Launches New Collaboration to Develop Gene-Based Cures for Sickle Cell Disease and HIV on Global Scale | HIV.gov

NIH Launches New Collaboration to Develop Gene-Based Cures for Sickle Cell Disease and HIV on Global Scale

The National Institutes of Health and the Bill & Melinda Gates Foundation each plan to invest at least $100 million over the next four years toward an audacious goal: develop affordable, gene-based cures for sickle cell disease and HIV...

LEARN MORE

Collecting Roses: The Catholic University Film Collection Finding Aid – Circulating Now from NLM

Collecting Roses: The Catholic University Film Collection Finding Aid – Circulating Now from NLM

Bulk track hub settings now in Genome Data Viewer

10/24/2019 03:36 PM EDT

You now have access to bulk settings options for track hubs  in the Genome Data Viewer (GDV) and Sequence Viewer. These settings allow you to pick the default tracks that load into the viewer from your chosen track hub.  You … Continue reading →

Collecting Roses: The Catholic University Film Collection Finding Aid

10/24/2019 11:00 AM EDT

By Ethan Cheng ~ I’ve always wanted to work in a library. As a student of the life sciences spending the summer doing neuroscience research

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HPV Vaccine Herd Immunity against Oral HPV Infections in Men - National Cancer Institute

HPV Vaccine Herd Immunity against Oral HPV Infections in Men - National Cancer Institute

HPV Vaccine May Provide Men with “Herd Immunity” against Oral HPV Infections

October 8, 2019, by NCI Staff

Credit: National Cancer Institute

The potential benefits of vaccines are twofold: In addition to directly protecting those who get the vaccine, they also protect those who don’t. The latter, a phenomenon called herd immunity, occurs as more and more people get vaccinated, further restricting the ease with which the disease-causing germ can spread.

Now a new study suggests that the human papillomavirus (HPV) vaccine may be providing men with herd immunity against HPV infections of the throat. Oral HPV infections cause over 70% of all oropharyngeal cancers in the United States, and rates of these cancers in men have skyrocketed over the past several decades.

Between 2009 and 2016, rates of HPV vaccination in both males and females increased while rates of oral HPV infection among unvaccinated men dropped, the new study showed.

Results of the study, which was led by Anil Chaturvedi, Ph.D., and Barry Graubard, Ph.D., of NCI’s Division of Cancer Epidemiology and Genetics, were published September 10 in JAMA.

The findings “add to accumulating evidence that HPV vaccination prevents oral infection with HPV,” said Gregory Zimet, Ph.D., of Indiana University, who studies HPV vaccine uptake but was not involved in the current study.

That is “really meaningful,” Dr. Zimet added, because it is difficult to catch oropharyngeal cancers at their early, most treatable stages. More than half of oral cancers have already spread to other places in the body by the time they are discovered.

Prevention of oral HPV infections today can prevent oropharyngeal cancers in the future, Dr. Chaturvedi said.

Oral HPV Infections and Oropharyngeal Cancer

More than a decade ago, Dr. Chaturvedi and his colleagues reported that rates of oropharyngeal cancer were climbing rapidly in the United States, particularly among young men. The cause of this alarming jump turned out to be a rise in oral HPV infections. The other major causes of oropharyngeal cancer are smoking and heavy alcohol consumption.

Subsequent studies showed that oral HPV infections and HPV-related oropharyngeal cancers are three to five times more common in men than women.

In 2009, Dr. Chaturvedi and his colleagues worked with the Centers for Disease Control and Prevention (CDC) to make oral HPV infections a focus of the National Health and Nutrition Examination Survey (NHANES), an ongoing health study of a representative sample of children and adults in the United States.

Since then, scientists have used data from NHANES to explore the epidemiology of oral HPV infections, including a 2017 study led by Dr. Chaturvedi that provided some preliminary evidence that the HPV vaccine may prevent oral HPV infections.

Investigating Herd Protection

Because there is accumulating evidence for herd protection against cervical HPV infections, Dr. Chaturvedi and his colleagues wondered whether a similar phenomenon existed for oral HPV infections. To explore that idea, the researchers turned to NHANES data once again.  

Between 2009 and 2016, nearly 14,000 men and women aged 18 to 59 participated in NHANES. Participants self-reported whether they had received the HPV vaccine and provided mouth rinse samples that were tested for 37 HPV types.

Gardasil, the most commonly used HPV vaccine between 2009 and 2016, protects against infection with four HPV types—two that cause most HPV-related cancers and two that cause genital warts. HPV vaccination has been routinely recommended for girls since 2006 and for boys since 2011.

During the time period of the study, HPV vaccination rates among NHANES participants rose from 0% to 6% for men and from 7% to 15% for women, the researchers found. Meanwhile, the prevalence of oral infections from the four HPV types covered by Gardasil went down by 37% among unvaccinated men in the study. The prevalence of oral infections with HPV types not covered by the vaccine, however, didn’t change.

Among unvaccinated women in the study, the prevalence of oral infections with all HPV types—both covered and not covered by Gardasil—didn’t change, the researchers found. Oral HPV infections were less common in women, making the rates too low to reliably estimate any changes over time, Dr. Chaturvedi explained.

Relying on participants to recall information about their vaccination status is a limitation of the study, Dr. Zimet pointed out. “It’s not the best way to assess whether someone has been vaccinated, but it is largely accurate and there’s no way to get around it … for this kind of study,” he said.

What This Means for HPV Vaccination

Although this study suggests that people who get vaccinated against HPV may provide some protection to those who don’t, that doesn’t mean that people should skip the vaccine, Dr. Chaturvedi noted.

These findings provide “preliminary evidence for a limited degree of herd protection that is much smaller than the direct benefit of getting vaccinated,” he stressed. Getting the HPV vaccine provides near complete protection from several cancer-causing types of HPV, he explained.

However, there are some people for whom herd protection is critical, Dr. Zimet noted, such as those who have an immune system disorder that precludes them from getting vaccinated or mounting a sufficient immune response to the vaccine.

“Establishing herd protection is really a social responsibility,” he said.

The bottom line, then, is that “every eligible individual should get vaccinated,” Dr. Chaturvedi said. CDC’s Advisory Committee on Immunization Practices recommends HPV vaccination for all boys and girls at age 11 or 12, and for people through age 26 if they weren’t already vaccinated.

But according to data from 2018, only 51% of teens have completed the HPV vaccine series, Dr. Zimet noted. A goal of Healthy People 2020, a government-led initiative to improve the health of all Americans, is to reach an 80% vaccination rate for HPV by the year 2020.

“We’re a long way from that,” he said.

Does the HPV Vaccine Protect against Oral Infections?

An NCI-funded clinical trial of Gardasil 9—the most recent formulation of the HPV vaccine, which covers 5 additional cancer-causing HPV types—will determine whether the vaccine can prevent persistent oral HPV infections among men who are HIV positive. Oral HPV infections and HPV-related oral cancers are more common in men and among HIV-positive individuals.

“We are hoping that if we show efficacy of the vaccine, that vaccinating both males and females will ultimately reverse” the rising incidence of HPV-related oropharyngeal cancers, said one of the trial’s lead investigators, Anna Giuliano, Ph.D., of Moffitt Cancer Center. The trial is one of several within the US–Latin American–Caribbean Clinical Trials Network, an NCI-led effort to reduce the burden of HPV-related cancers in HIV-positive individuals.

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