Category Archives: Hormone Replacement Therapy

A few years ago, the use of hormone replacement therapy (HRT) looked like a medical mess. For decades, women were told that HRT -- usually a combination of estrogen and progestin -- was good for them during and after menopause. Then the 2002 results of the Women's Health Initiative study seemed to show just the opposite: hormone replacement therapy actually had life-threatening risks such as heart attacks, strokes, and cancer.

"Women felt betrayed," says Isaac Schiff, MD, chief of obstetrics and gynecology at Massachusetts General Hospital in Boston. "They were calling their doctors, saying, 'How could you put me on this drug which causes heart attacks, strokes, and cancer?'"

Almost overnight, standard medical practice changed. Doctors stopped prescribing hormone replacement therapy and 65% of women on HRT quit, according to Schiff.

But some experts say hormone replacement therapy may be coming back. All along HRT remained an important treatment for menopause symptoms like hot flashes. And now, a number of recent studies show that hormone replacement therapy may have protective benefits for women who are early in menopause.

"I think we swung too positive on hormone therapy in the past and then we went too negative," says Schiff, who is also chair of the American College of Obstetricians and Gynecologists Task Force on Hormone Therapy. "Now we're trying to find a balance in between."

"We're definitely in a gray zone of uncertainty about hormone therapy," says Jacques Rossouw, MD, project officer for the federal Women's Health Initiative (WHI). "But when you're uncertain, you have to err on the side of safety."

While Rossouw concedes that new studies show some preventative benefit for younger women, he says any potential benefit is very slight. And, he notes, there is no evidence that any benefit would last if women kept taking hormones as they got older.

But increasing numbers of researchers say there should be a place for hormone replacement therapy as a preventive treatment for limited periods as it may help prevent disease in younger women around the age of menopause.

"We have evidence that hormone therapy can prevent heart disease, hip fractures, and osteoporosis, and that it cuts the risk of developing diabetes by 30% in younger women," says Shelley R. Salpeter, MD, a clinical professor of medicine at Stanford University's School of Medicine.

In one recent study, Salpeter and her colleagues found that HRT reduced the number of heart attacks and cardiac deaths by 32% in women who were 60 or younger (or women who had been through menopause less than 10 years ago). In older women, hormone replacement therapy seemed to increase cardiac events in the first year, and then began to reduce them after two years.

The 32% drop is significant, but perhaps not as dramatic as it sounds. In hard numbers, Salpeter estimates that of women aged 50 to 59 who don't get hormone replacement therapy, about 7 out of 4,800 will have a cardiac event in one year. With HRT, 3 out of 4,800 will have a cardiac event.

Salpeter's study indicates something crucial: The age at which a woman starts HRT may make a big difference.

Salpeter argues that when a person first starts hormone replacement therapy, her risk of blood clots increases slightly. In healthy women who are in their 50s -- and close to the age of menopause -- this increase is very unlikely to cause problems. The higher risk subsides after a couple of years, she says, although other experts disagree.

But women in their 60s may be more likely to already have early heart disease or hardening of the arteries (arteriosclerosis). In these cases, the risk of blood clots becomes more serious. So if a woman first starts hormone replacement therapy in her 60s, the initial risks are more dangerous, Salpeter says.

This is what Salpeter says affected the results of the Women's Health Initiative trial. The average age of a woman in that trial was 63, with a range of ages between 50 and 79. She and other critics argue that the researchers were looking at many women who might already have been sick.

"I was surprised when I first heard the [WHI] results," says Lynne T. Shuster, MD, director of the Women's Health Clinic at the Mayo Clinic in Rochester, Minn. "But, once I saw the details, I wasn't surprised anymore. They gave women who were older and possibly had underlying arteriosclerosis a pill that increased the risk of blood clotting. Of course it increased the risk of heart problems."

Shuster and Salpeter argue that those results have no bearing on whether younger, healthy women in their 50s would benefit from HRT.

"Basically, [the WHI researchers] were looking at the wrong group of people," Salpeter tells WebMD.

Rossouw defends the WHI study design. "We were specifically testing the hypothesis that hormone therapy would help protect older women against disease," Rossouw tells WebMD, "The results were absolutely clear: They do not."

Media reports on the WHI results may have given people inflated fears of hormone replacement therapy's risks, the doctors say.

For example, the Women's Health Initiative results showed that combined hormone replacement therapy seems to increase the risk of breast cancer by 33%, Schiff says. That's a serious increase. Still, the risk to any one woman is not as high as it sounds, Schiff says.

"According to the WHI, without hormone therapy, 3 of every 1,200 women aged 55 to 59 will develop breast cancer this year," says Schiff. "With hormone therapy, 4 out of 1,200 will. It's a 33% increase, but the absolute risk is still very, very small."

Shuster points out that other behaviors -- like drinking two glasses of wine a night -- also increase breast cancer risk by a similar amount.

Women who take estrogen alone -- a treatment only available to people who have had a hysterectomy -- appear to have a lower risk of developing breast cancer than women who take progestin and estrogen together. In a 2006 JAMA article, researchers from the Women's Health Initiative found that after about seven years of treatment with estrogen, there seemed to be no increased risk of breast cancer.

However, estrogen-only therapy may have long-term risks. A May 2006 study published in the Archives of Internal Medicine found using estrogen-only therapy for 20 years or more showed increased risk of developing breast cancer.

As HRT is being re-evaluated -- and new evidence is coming in -- it's difficult to know who should get hormone replacement therapy and for how long.

The U.S. Food and Drug Administration (FDA) recommends that HRT should be used in women who have severe menopausal symptoms.

"Estrogens are the best agents we have for the relief of menopausal symptoms like hot flashes, vaginal dryness, and loss of sexuality," says Schiff. They're also a good treatment for menopausal symptoms that are often not recognized: Difficulty sleeping, stiffness, joint pain, and mood changes.

But for disease prevention -- lowering the risk of heart attacks, strokes, and most cases of osteoporosis -- the FDA still does not recommend hormone replacement therapy.

"We have other ways of cutting the risks of heart attacks and strokes," Schiff tells WebMD, including better diet, exercise, and other medicines.

Will HRT ever again be used as prevention for these serious diseases? Only time and research will tell. The experts remain divided.

"I believe that studies in the next few years will support using hormone therapy in younger women [closer to the onset of menopause] for prevention," says Shuster. "But "we don't have all the information yet."

Another big question is how long hormone replacement therapy can be used safely. It was once thought that using it for five years or less to relieve menopausal symptoms had no risks. But the WHI study seemed to show that was not the case.

There are still a lot of unknowns. Many women now take doses of hormones that are lower than the ones used in the WHI trial. Hormones are also delivered not just through pills, but in other forms, like skin patches. We don't know yet whether these lower concentrations and different forms might decrease the risks.

For now, the FDA recommends that women who take hormone replacement therapy for menopausal symptoms take the lowest effective dose and for the shortest time period to alleviate symptoms.

With all of the contradictory messages, it's hard for a woman to know what to do. There's also a lot of lingering anger about what happened in the wake of the Women's Health Initiative results.

"I lost a lot of faith in my doctors after that," says April Dawson, a 63-year-old Connecticut woman who used hormone replacement therapy for about a year. "And all of the women I know feel the same way.

"In the first place, I didn't like the idea of going on medication when I didn't have any symptoms," Dawson tells WebMD. "But I feel like my doctors ganged up on me and pushed me to take it."

Today, doctors are far more likely to tell each woman that she must make the decision herself, weighing the pros and cons of hormone replacement therapy, considering her symptoms, family history, lifestyle, and risk of disease.

If you take HRT, keep in mind that the absolute risks are low. But you should still regularly check in with your doctor. Ask if there is any new information that might cause you to rethink your decision.

"Hormone therapy is a field that continues to change rapidly," says Shuster. "Treatment has to be more individualized than ever. Women are seeking the one right answer, but for now, we just don't have one."

SOURCES: American College of Obstetricians and Gynecologists web site,"Frequently Asked Questions about Hormone Therapy, "News release: ACOG IssuesState-of-the-Art Guide to Hormone Therapy." Chen, WY et al, Archives ofInternal Medicine, May 8, 2006; vol 166: pp1027-1032. April Dawson,Milford, Conn. Jacques Rossouw, MD, project officer for the Women's HealthInitiative at the National, Heart, Lung and Blood Institute, Bethesda, MD.Salpeter, SR et al, JGIM, July 2004; vol 21: pp 363-366. Salpeter, S,Climacteric 2005; vol 8: pp307-310. Salpeter, SR et al, Diabetes,Obesity and Metabolism, in press. Salpeter, SR et al, Journal ofGeneral Internal Medicine, July 2004; vol 19: pp 791-804. Shelley R.Salpeter, MD, clinical professor of medicine at Stanford University's School ofMedicine. Isaac Schiff, MD, chief of obstetrics and gynecology at MassachusettsGeneral Hospital in Boston; chair of the American College if Obstetricians andGynecologists Task Force on Hormone Therapy. Lynne T. Shuster, MD, director ofthe Women's Health Clinic at the Mayo Clinic in Rochester, MN. Stefanick, ML etal, JAMA, April 12, 2006; vol 295: pp 1647-1657. U.S. Food and DrugAdministration web site, "Questions and Answers for Estrogen and Estrogen withProgestin Therapies for Postmenopausal Women."

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Hormone Replacement Therapy - webmd.com

If youre looking for relief from menopause symptoms, knowing the pros and cons of hormone replacement therapy (HRT) can help you decide whether its right for you.

HRT (also known as hormone therapy, menopausal hormone therapy, and estrogen replacement therapy) uses female hormones -- estrogen and progesterone -- to treat common symptoms of menopause and aging. Doctors can prescribe it during or after menopause.

After your period stops, your hormone levels fall, causing uncomfortable symptoms like hot flashes and vaginal dryness, and sometimes conditions like osteoporosis. HRT replaces hormones your body no longer makes. Its the most effective treatment for menopause symptoms.

You might think of pregnancy when you think of estrogen. In women of child-bearing age, it gets the uterus ready to receive a fertilized egg. It has other roles, too -- it controls how your body uses calcium, which strengthens bones, and raises good cholesterol in the blood.

If you still have your uterus, taking estrogen without progesterone raises your risk for cancer of the endometrium, the lining of the uterus. Since the cells from the endometrium arent leaving your body during your period any more, they may build up in your uterus and lead to cancer. Progesterone lowers that risk by thinning the lining.

Once you know the hormones that make up HRT, think about which type of HRT you should get:

Estrogen Therapy: Doctors generally suggest a low dose of estrogen for women who have had a hysterectomy, the surgery to remove the uterus. Estrogen comes in different forms. The daily pill and patch are the most popular, but the hormone also is available in a vaginal ring, gel, or spray.

Estrogen/Progesterone/Progestin Hormone Therapy: This is often called combination therapy, since it combines doses of estrogen and progestin, the synthetic form of progesterone. Its meant for women who still have their uterus.

The biggest debate about HRT is whether its risks outweigh its benefits.

In recent years, several studies showed that women taking HRT have a higher risk of breast cancer, heart disease, stroke, and blood clots. The largest study was the Womens Health Initiative (WHI), a 15-year study tracking over 161,800 healthy, postmenopausal women. The study found that women who took the combination therapy had an increased risk of heart disease. The overall risks of long-term use outweighed the benefits, the study showed.

But after that, a handful of studies based on WHI research have focused on the type of therapy, the way its taken, and when treatment started. Those factors can produce different results. One recent study by the Fred Hutchinson Cancer Research Center reveals that antidepressants offer benefits similar to low-dose estrogen without the risks.

With all the conflicting research, its easy to see why HRT can be confusing.

If you have these conditions, you may want to avoid HRT:

HRT comes with side effects. Call your doctor if you have any of these:

Your doctor can help you weigh the pros and cons and suggest choices based on your age, your family's medical history, and your personal medical history.

SOURCES:

Garnet Anderson, PhD, director, public health sciences division, Fred Hutchinson Cancer Research Center, Seattle.

Cleveland Clinic: Hormone Therapy (HT), Understanding Benefits and Risks.

John Hopkins Medicine: Hormone Therapy.

Journal of the American Medical Association, Oct. 2, 2013.

Main Line Health: Estrogen, Progesterone, and Menopause.

JoAnn E. Manson, MD, DrPH, chief, preventative medicine division, department of medicine, Brigham and Womens Hospital, Boston.

National Cancer Institute: Menopausal Hormone Therapy and Cancer Fact Sheet.

National Heart, Lung, and Blood Institute: Womens Health Initiative.

National Institutes of Health: WHI Study Data Confirm Short-Term Heart Disease Risk of Combination Hormone Therapy for Postmenopausal Women.

National Institute on Aging: Hormones and Menopause."

North American Menopause Society: Hormone Therapy for women in 2012.

Office on Womens Health, U.S. Department of Health and Human Services: Menopausal hormone therapy (MHT).

U.S. Preventative Services Task Force: Understanding Task Force Recommendations: Menopausal Hormone Therapy for the Primary Prevention of Chronic Conditions.

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Hormone Replacement Therapy for Menopause - webmd.com

Bioidentical Hormone Replacement Therapy (BHRT) Dr Mark Richards

Mark E. Richards M.D.

Get Started, Call(301) 468-3458

Bio-identical testosterone or estrogen hormones taken by mouth are inactivated in the liver before ever getting into your circulation. Bio-identical creams or injections have large variations in their blood levels and an inconsistency in the amount of hormone they provide to your tissues. Bio-identical pellets have been shown to provide close to a steady state availability of hormone for months. Bio-identical hormone pellets have been used in the United States since 1939.

Bio-identical hormones have the exact same chemical and molecular structure as hormones that are made in the human body. The difference between a bio-identical hormone versus a hormone that is not bio-identical is the molecular structure and shape of the hormone. Why is this important? Think of a hormone as a key and the receptor which it activates as a lock. In order for a replacement hormone to exactly replicate the function of the hormone that humans naturally produce, the bio-identical replacement I provide must exactly match the human hormone. It is the structural differences that exist between human bio-identical and non-bio-identical hormones that are responsible for serious side effects and sometimes fatal health risks that occur when non bio-identical hormones are used in humans.

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Ready to Get Started? CLICK HERE or Call: (301) 468-3458

Dr. Mark Richards is one of a handful of nationally and internationally recognized experts in the emerging field of bio-identical pellet hormone therapy. He instructs physicians in how to start this therapy in their practices. He also lectures to physicians at medical specialty conferences (Plastic Surgery and Anti-Aging) regarding the extensive science of the last 70 years supporting the use of bio-identical hormone pellets to enhance and restore health and well-being in aging humans. He has practiced and taught Plastic Surgery for over 21 years, and has practiced and educated others in bio-identical pellet therapy since 2008. He is board certified in Plastic Surgery.

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FREMONT, Neb. It's often called "The Change" and for some women - it really does change your life. Menopause usually takes place in your 40's or 50's and it affects every woman differently. In today's Health Check, Serese Cole breaks down the signs and the treatment available to get you through it.

For Nancy Low, there's nothing better than a hot summer day.

"I like to be outside and garden," Low explained.

But when she reached her late forties, the heat - became a problem.

"I'm just hot - inside - and you get a little sweaty and you need some fresh air," she said.

She was also tired and irritable.

"I had mood changes...the emotional cry at the drop of a hat over nothing...I was getting to where I didn't want to go anywhere, do anything because I just didn't feel good," Low added.

Nancy had to see a doctor

After hearing her symptoms, Fremont Health's Dr. Karen Lauer-Silva confirmed what Nancy already knew.

"Menopause is very different for every person," Dr. Lauer-Silva said.

Some of those differences happen without you even knowing.

"Silently bones loss happens during menopause," Dr. Lauer-Silva explained.

Not so silent - the hot flashes, night sweats and mood instability.

Dr. Lauer-Silva, "It can affect your relationships for sure, relationships at work, significant people in your lives,"

The good news is there are a number of ways symptoms can be managed. Over-the counter-medication, natural remedies like herbal supplements and low dose anti-depressants can bring women relief.

And..

"There are wonderful hormones which really honestly have the biggest change - the fastest and do the best," the doctor said.

Hormone replacement therapy gives your body the estrogen you lose during menopause. But there are some risks - like blood clots and an increased risk for some cancers like - uterine and breast cancer.

"The American College of OB-GYN concluded that the lowest effective dose for the shortest period of time was the way to go for hormone replacement and that five years appears to be safe," said Dr. Lauer-Silva said.

Nancy decided the risk was worth the benefit.

After just four days of taking her hormones, she feels like herself again.

"I have more energy. I'm sleeping at night, my hot flashes are still there, but they're not intense like they were. I'm easier to get along with," Low said with a smile.

And her time out in the summer sun - is back on.

Dr. Lauer-Silva says you don't know have to suffer through this phase of your life. There are a lot of options out there - from patches and creams - to injections. You just need to talk with your doctor about the best plan for you.

More:
Making your way through Menopause - WOWT

Dozens rally for transgender troops in Palm Springs. Omar Ornelas, The Desert Sun

Members of the community attend a rally on Arenas Road in Palm Springs in support of transgender members of the U.S. military. (Photo: Omar Ornelas/The Desert Sun )Buy Photo

Two desert residents filed a lawsuit against the Trump administration Tuesday, arguing that their plans to join the armed forces had been dashed by the president's decision to bar transgender people from military service.

Aiden Stockman, 20, of Yucca Valley and Tamasyn Reeves, 29, of Desert Hot Springs, say they had met with recruiters and were preparing for enlistment when President Donald Trump tweeted on July 26.

The tweet read in part: "The United States Government will not accept or allow Transgender individuals to serve in any capacity in the U.S. Military."

On Aug. 25, Trump formalized the policy with a memo to the the Departments of Defense and Homeland Security, ordering that they reinstate a ban on openly transgender people in the military.

VALLEY VOICE: Military trans ban hits home for local minister

The Obama administration had lifted the ban on transgender servicemembers in June 2016. Trans people already in the military were permitted to serve openly; trans people who wanted to enlist could do so beginning July 1, 2017.

Trump's tweet revoking the policy came less than a month later meaning trans people who wanted to enlist had only about four weeks in which they could have done so.

The lawsuit namesTrump and five military officials, including Secretary of Defense James Mattis and Chairman of the Joint Chiefs of Staff Joseph Dunford, Jr., as defendants.

The defense hasnot yet responded to the complaint in court.

Aiden Stockman and a Yucca Valley classmate attend the Harvey Milk Diversity Breakfast on Friday in Palm Springs.(Photo: Lauren Reyes/The Desert Sun)

According to the complaint, Aiden Stockman grew up in the high desert and frequently talked to neighbors stationed at Twentynine Palms about military service. But he felt deep discomfort in his own body, including binding his breasts to hide the curve and even attempting suicide, Stockman told Palm Springs' Harvey Milk Diversity Breakfast in 2015.

Then, in 2014,he began hormone replacement therapy, and later that year, he took the Armed Services Vocational Aptitude Battery test a prerequisite placement test for military service.

Inthe year following his 2015 graduation, Stockman scheduled an appointment for a double mastectomy surgery. He planned to enlist shortly after.

"Upon learning of the August 25 Directive, Mr. Stockman felt crushed, as he will no longer be able to pursue his dream of serving his country in the Air Force," attorneys wrote in the complaint.

READ MORE: Transgender community navigates sea of healthcare obstacles

Tamasyn Reeves first met with a recruiter eight years ago, when she was 21, but was told she couldn't serve because the military still barred openly LGBT people from service. She began hormone replacement therapy two years later.

Members of the community attend a rally on Arenas Road in Palm Springs in support of transgender members of the U.S. military. (Photo: Omar Ornelas/The Desert Sun )

After the Obama administration opened the military to transgender members, "Ms. Reeves decided to enlist as soon as the final procedures for accession of transgender individuals were solidified."

But Reeves missed the window in Julywhen she could've enlisted as an openly trans person.

READ MORE: Some transgender people escape to the Coachella Valley for a safe haven. But why can't they find work?

Frank Pizzurro, a spokesperson for Latham & Watkins LLP, confirmed Peterson and Reeves' cities of residence.

Four other transgender people who'd hoped to join the military are party to the suit, as is Equality California, one of the state's largest LGBT advocacy organizations.

Contrary to what the President states, ejecting loyal members of the armed forces promotes chaos and division, not unit cohesion, said Rick Zbur, executive director of Equality California, in a statement. The cost to the government of transition-related care is negligible. On the other hand, discharging thousands will cost taxpayers hundreds of millions of dollars and will rip trained and loyal servicemembers out of their units, harming military readiness and requiring the military to find and pay to train replacements."

Reach the reporter at rosalie.murphy@desertsun.com.

Read or Share this story: http://desert.sn/2xPcr7W

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Transgender military ban leaves man 'crushed' and woman misses window to enlist. Now these desert residents are ... - The Desert Sun

(Reuters Health) - Using vaginally applied estrogen to ease menopause symptoms likely doesnt increase a womans risk of heart disease or certain cancers, a U.S. study suggests.

Many women have been reluctant to use hormone replacement therapy (HRT) for menopause symptoms since 2002, when the federally funded Womens Health Initiative (WHI) study linked pills containing man-made versions of the female hormones estrogen and progestin to an increased risk for breast cancer, heart attacks and strokes. Some women have also been reluctant to use vaginally applied estrogens, which can ease symptoms like dryness and painful intercourse.

For the current study, researchers examined data on 45,663 women in the WHI study who didnt take HRT pills. After an average follow-up of more than six years, there wasnt a meaningful difference in the odds of cancer, stroke or blood clots based on whether or not women used vaginal estrogen.

The results of the study suggest that the use of vaginal estrogen may not actually carry the same health risks as the use of estrogen pills, said lead study author Dr. Carolyn Crandall of the David Geffen School of Medicine at the University of California, Los Angeles.

These results are reassuring, Crandall said by email.

Women go through menopause when they stop menstruating, typically between ages 45 and 55. As the ovaries curb production of the hormones estrogen and progesterone in the years leading up to menopause and afterward, women can experience symptoms ranging from irregular periods and vaginal dryness to mood swings and insomnia.

Study participants who used vaginal estrogen were less likely to be black or African-American, Hispanic, current smokers, diabetic or obese. They were also more likely to be white and college graduates with household income of more than $100,000 a year.

Compared with women who didnt use vaginal estrogen, women who did had a 48 percent lower risk of heart disease and 60 percent lower odds of hip fractures, researchers report in Menopause.

When researchers looked just at women who still had a uterus, the results looked even more favorable for vaginal estrogen users.

Among women who had not had their uterus removed, vaginal estrogen users were 61 percent less likely to have heart disease, and 60 percent less likely to have a hip fracture than women who didnt use vaginal estrogen.

The study wasnt a controlled experiment designed to prove whether or how vaginal estrogen might influence the odds of heart disease, cancer or other health problems.

Another limitation of the study is that researchers lacked data on different types of vaginal estrogen, so they couldnt tell whether one form might be best for avoiding cancer or heart disease.

Even so, the findings should reassure women, said Dr. Michelle Warren, medical director of the Center for Menopause, Hormonal Disorders and Womens Health in New York City.

This shows that it is perfectly safe for any woman to take low-dose vaginal estrogen, Warren, who wasnt involved in the study, said by email.

Some women who have avoided vaginal estrogen because they thought it was just as risky as pills may now be able to get relief for previously untreated menopause symptoms, said Dr. Michael Thomas of the University of Cincinnati Academic Health Center in Ohio.

A study like this allows women to safely use a form of estrogen that will help their (vaginal) symptoms, Thomas, who wasnt involved in the study, said by email. They can have intercourse without pain and feel safe they are not risking their life.

SOURCE: bit.ly/2eI0A6R Menopause, online August 14, 2017.

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Vaginal estrogen not tied to cancer or heart disease risks - Reuters

The physician whom STAT lists as author of a now-retracted op-ed praising the vital role of drug company sales representativesdidnt actually write the piece.

Robert Yapundich, MD revealed this key detail in a telephone interview with me yesterday. He stated unequivocally that he did not come up with the idea for the article or compose the first draft of the piece. He said he provided edits to material that originated elsewhere.

Who wrote the article, then?

Here is Yapundichs account of how the events surrounding the op-ed unfolded:

Thats when the problems began in earnest.

As we reported earlier this week, Yapundich received more than $300,000 from the drug industry between 2013 and 2016, according to the federal Open Payments database. And yet disclosure of that conflict of interest was initially missing from Yapundichs op-ed; it was added only after an outcry in the comments section of the STAT piece and on Twitter.

Robert Yapundich, MD

Yapundich says he understands the importance of such financial disclosures and that the omission was unintentional. It resulted from miscommunication with AfPA and uncertainty regarding the disclosure requirements.

In regards to COI, Im not sure what is needed, he recalled writing to his AfPA liaison. Do you need the company names? Which years? What type of COI?

His contact reportedly wrote back: Hold on financial info. Hopefully only needed for AfPA and not for you individually.

Thats the last Yapundich heard about the disclosure issue until STAT called him to clarify, he says.

STAT acknowledged the omission by revising the author bio that originally appeared at the end of the article. Heres how it reads now:

Robert Yapundich, M.D., is a neurologist practicing in Hickory, N.C., and a member of the Alliance for Patient Access. The alliance, which receives funding from pharmaceutical companies, supports regulations that expand manufacturers ability to discuss off-label uses, particularly those that are accepted in compendia and practice guidelines or reimbursed by the government and insurers. According to OpenPaymentsData, Dr. Yapundich was paid $332,294 by industry between 2013 and 2016.

Editors note: This article was updated to include Dr. Yapundichs ties with industry, which were not disclosed to STAT.

So STAT finally clarified more than four days after first publishing the piece that Yapundich has a significant conflict of interest regarding this topic. But in clarifying the extent of the authors financial relationship with the drug industry, STAT raised yet more troubling questions about the articles provenance and authenticity.

Pat Skerrett, who edits the First Opinion section where the op-ed appeared in STAT, offered a slightly different explanation than Yapundich for the missing drug industry disclosures. Writing in an email he said:

I just now got off the phone with the [Yapundich]. He confirmed the industry payments, and said he had mentioned them to the PR company he was working with but that they were not passed along to STAT. [emphasis added]

This was the first indication Id received of any PR company involvement with the article.

The PR firm, which Skerrett identified as Keybridge Communications, touts itself as a DC-based public relations firm that specializes in op-eds, issues advocacy, writing, media placement, and web development. Heres their promotional pitch:

We brand thought leaders. Our goal is to get your message in front of your target audience, whether its influencers and consumers or lawmakers and voters. Opinion media drives the public debate and enables our clients to expand their footprint, sway attitudes, and achieve their strategic goals.

Exactly whose message was Keybridge trying to advance with placement of the STAT op-ed?

Bill Snyder, an associate at the firm, whose name was given to me by STATs Skerrett, declined to answer specific questions about who was paying the bills for the op-ed and what role his firm may have played in the editorial development of the piece. He cited client non-disclosure agreements.

His explanation of the financial disclosure confusion appears to cast blame on STAT for not being thorough enough. But it may also reflect failure to respect accepted standards for acknowledging conflict of interest.

As you know, Snyder wrote, Dr. Yapundich has many relationships with the pharmaceutical industry. This is no secret; the relationships are publicly detailed here. We didnt send this along as we were under the impression that the editor was asking about the Alliance for Patient Access, and Dr. Yapundich wrote the piece in his capacity as a member of AfPA.

Without seeing the entire exchange, its hard to know whether Keybridges impression here is justified. No matter what capacity Yapundich was writing in, his personal financial relationships are obviously relevant. They should have been included if there was any doubt at all as to what STAT was asking for.

Keybridge is well known for ghostwriting on political and health care issues. It has acknowledged a previous client relationship with the Pharmaceutical Research Manufacturers Association of America (PhRMA), among other pharmaceutical interests. It seems apparent that they also have some involvement with AfPA, the pharma-backed advocacy group.

Susan Hepworth

For his part, Yapundich suggested that the initial draft originated somewhere within AfPA. But given the financial backing this group receives from the drug industry, this may be a distinction without much difference. Moreover, Yapundich named Susan Hepworth as the Alliance employee who sent him the draft. She is also listed as a media relations expert for a different DC public relations firm, Woodberry & Associates. According to her bio, She focuses on driving and echoing strategic messages for its health care and education clients through the development and execution of an earned media strategy that includes both traditional and digital media, as well as surrogates.

It seems that wherever the op-ed originated, it received careful attention from PR messaging pros before it ever reached Yapundichs desk.

The practice of op-ed ghostwriting is common among politicians and celebritiesand is accepted by many editorial page editors.

But the STAT situation is different and poses significant ethical concerns, says Charles Seife, a professor of journalism at New York University.

Ethically ghostwriting becomes a problem when you have a big concern like a pharmaceutical company thats trying to put words in the mouth of the little guy, he told me. Why is it necessary to omit the name of the person who actually wrote the piece, unless youre trying to obscure the hidden hand of someone behind the scenes whos more powerful?

Charles Seife

Seife drew a parallel to Wyeths use of ghostwriters to promote the hormone replacement therapy Prempro in the medical literature. He said the company penned journal articles and recruited physicians to put their names on them. The reason you do that is to hide the influence of the drug company and to increase the impact more than you wouldve had otherwise, he said.

Its shocking if STAT is allowing this to go on, he added. Its a real blow to their credibility.

Writing in the comments section of the STAT piece, Seife had previously drawn attention to what he described as an implausible story about Yapundichs interaction with a drug company sales rep. Yapundich is listed as a promotional speaker for Acadia Pharmaceuticals drug Nuplazid in the Open Payments database. However, the STAT piece suggests that he had learned of this particular medication from a company-sponsored lunch program. That knowledge led to a patient encounter that resulted in a direct clinical benefit, according to the op-ed.

Thanks to what I had learned at the lunch program, I informed the family about this new medication and wrote a prescription for it. The drug eased the patients symptoms enough that family has been able to continue caring for him at home.

Ive heard shifting explanations as to how this particular anecdote actually went down, and I second Seifes call for an investigation to reconcile the discrepancies.

According to an email from STATs Skerrett, [Yapundich] said he absolutely did not fabricate any stories, as Charles Seife alleged. He said he heard about the Parkinsons drug from an industry rep, and spoke on its behalf later.

But in my telephone conversation with Yapundich, he told me that he was already being paid to speak on behalf of the drug when the sales rep interaction occurred. In fact, Yapundich said, his ghost-written article didnt correctly convey the details of what took place in the anecdote.

It didnt come out the way I intended it to, he said, speaking of the op-ed that carried his name. The article made it seem like Id never seen the drug before and that was not what I intended.

He told me he was well aware of the drug at the time of the encounter with the sales rep, and that the rep had said something interesting about the drug new medication data, Yapundich called it that set off a light bulb in his mind and subsequently led to the positive patient encounter.

I hope there arent other parts of the article that escaped my editorial oversight or review, Yapundich said. The next time I do one of these op-eds, I should be the one doing the drafting and they should be the ones doing the editing and reviewing.

Its worth repeating that STAT has a well-earned reputation for editorial excellence and hard-nosed reporting. A single lapse wont tarnish it.

Yet the issues raised by this situation cut to the heart of STATs credibility as a news source. And theyre not the only issues that were concerned about.

Here are my takeaways and suggestions for how STAT could proceed to repair the damage:

Lastly, I would encourage STAT to work more proactively to ensure the quality and authenticity of opinion page submissions. While authors of op-eds may get more latitude than they would in a straight news piece, the boundaries shouldnt be so wide as to include ghost-written puff pieces from PR companies.

When I raised pointed questions about my concerns with STAT editors, they declined to offer a detailed response or even make an attempt to investigate further and get back to me. They told me I was welcome to do that [myself].

It is the job of STAT to correct this. Not HealthNewsReview.org or any other external entity. STAT has a big, well-funded operation some of it supported by drug companies. Its a matter of ethical decision-making. What kind of operation do they want to be?

With the cost of medications approaching stratospheric levels, criticisms of the drug industry have been

[NOTE: This post has been updated. Scroll to the bottom for details.] I woke up

Maybe it's just seeing this - again - on the day after the President signed

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'A blow to [STAT's] credibility': MD listed as author of op-ed praising drug reps didn't write it. Ghostwriting/PR ... - HealthNewsReview.org

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Anita Green, 26, will compete in this weekend's Miss Montana USA pageant, the first openly trans woman to do so in the state (and one of the first in the country as a whole). Green is a University of Montana alumna and currently works for an organization that supports people with developmental disabilities. She also made state history last year by becoming the first openly transgender person to be elected as a delegate to a nominating convention. A pageant newbie, Green hopes her presence in the competition will inspire other trans women and she's planning to win for them too.

I have never competed in a pageant before I had been thinking about it for a couple of years now but I wasn't sure if I necessarily had what it took to compete. I hadnt felt confident in myself before but I do now. I began surrounding myself with more positive people in my life people who believed in me, people who knew I could do this.

"If I am selected as Miss Montana USA, I am going to be representing my state and that's something that I don't take lightly."

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I thought it would be fun too; I have never gotten glammed up so much before! My makeup experience has been very limited, so I have been watching a lot of YouTube tutorials on how to do my hair and whatnot. I've never gotten on stage in a bathing suit before either and that's really exciting. But I am taking the pageant very seriously if I am selected as Miss Montana USA, I am going to be representing my state and that's something that I don't take lightly.

For me, it was very difficult growing up as a trans woman. For the longest time, I didn't understand that I even was transgender that's not something that was talked about in the '90s. For the longest time, I thought that I was just gay because I knew that I was attracted to men, but then, as I got older, I discovered that I indeed was and am a transgender woman. I didn't have a lot of resources growing up to help me with my gender dysphoria so it was difficult; I was suffering from clinical depression because I was living a lie for a good portion of my life and I became depressed because of that. I think I was 17 when I first came out as transgender. I came out to my best friend in high school and I told her I was a girl. At 18, I started hormone replacement therapy, and I was in therapy to deal with my gender dysphoria, and I started living full-time as me, as Anita, the woman that I am, at 19.

Of course I'm a little bit nervous [about the pageant]. I think that all of the contestants are a little bit nervous. I hope that I'm prepared and ready. I think I am. I've been practicing a lot in heels; I've worn heels more in the past few months than I have in my entire life. I would describe my pageant runway walk as being on par with Sandra Bullock's character from Miss Congeniality. I was struggling at first but with a lot and I mean a lot of practice, I'm ready to show off on stage! I have also been working out a lot. I've actually lost about 50 pounds [in the] last year with diet and exercise, and it's been a lot of work [but even] making small changes like cutting out soda is a good start. I think that this pageant has been very good for me in that respect. It's helped encourage me to be healthier, and I'm seeing results, and I'm really liking them.

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And I have a message that I want the public to hear. I think that the Miss Universe Organization gives women an opportunity to have their voices heard; theyre encouraging a diverse group of woman to [get involved in pageants] and I think that's great. I want to make some progress for the transgender community because a lot of progress needs to be made. And I wanted to be a source of inspiration; I wanted to give the transgender community something positive some positive news. That's why I'm here.

"All the contestants that I have met so far have all been very accepting of me. I was pleasantly surprised!"

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My friends were very excited for me and have been giving me a lot of advice; I've been working with a pageant coach too, Michelle Font, a former Miss Washington USA. My partner has been super supportive of me every step of the way. I think my mom was a little bit hesitant at first; I'm not entirely sure why, but I think that she was maybe afraid that people would make fun of me or harass me because I'm really putting myself out there. But shes always wanted me to do my best and it didn't take her long to come around.

All the contestants that I have met so far have all been very accepting of me. I was pleasantly surprised! I live in Montana after all, which is a rural, conservative state. As for any haters talking about me, I really don't care at this point. I mean, some people are always going to bash others. I think that it's just important to compete as best I can and hold my head up high [while doing so] and hopefully others will see that. I don't know if my story will add [a new] perspective for people who arent accepting of [the trans community] or if they're going to continue to essentially be bigots, but I'm hopeful that I can change some minds, and I hope that people can see that what I'm doing is a positive thing.

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I'm very open about my identity at this point. [For the Miss Montana USA pageant,] I put that [I am a trans woman] in my contestant biography and I'm sure most of the contestants, if not all of them, have read over everybody else's bio. And during rehearsals, we all had to mention one interesting fact about ourselves and I mentioned that I was elected as Montana's first openly transgender national delegate [for the 2016 Democratic National Convention] and everyone, within the Miss category and the Miss Teen category, clapped for me.

[Going to the Democratic National Convention] was very exciting. It was also very stressful. I don't know if the DNC has seen such a controversial election. A lot of people felt that Bernie Sanders wasn't treated fairly and there were a lot of protests happening at the DNC. And in some ways, it was good because I think that it encouraged a lot more people to be involved in the political process. I wasn't expecting everyone to be getting so riled up, but they were and I was upset as well. I mean, Bernie Sanders was the person I wanted to be president of the United States.

I like to consider myself an educator. I think it's important to educate people and I understand that people sometimes have some questions they genuinely want to learn and I [see myself] as here to help. Now, some of the questions are invasive, but Im happy to explain what is appropriate to ask somebody and what isn't. I really just want to inform people about what it means to be transgender and, like I said, I think that we have a lot of issues within the transgender community that need to be addressed: I think that there should be federal laws making it illegal to discriminate against people based upon their perceived sexual orientation, gender identity, and/or gender expression [in terms of] access to employment and housing. Currently, in many places, it is legal to discriminate against people based on [those factors] and I think that that is egregious. I also think that transgender people shouldn't be required to undergo gender confirmation surgery in order to change the gender marker on their birth certificate, and the reason that I think that that needs to change on a federal level is because not every trans person can afford gender confirmation surgery, nor does every trans person want to have surgery!

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"I know that it's not easy being transgender but I think it's so important to be true to yourself because in the end, you are the one who's going to make you happy."

My platform involves fighting for the LGBTQI community, specifically for the transgender community because I think that the best person to be a spokesperson for any community is someone who is actually a part of it it's most appropriate for me to be speaking on behalf of the transgender community because I am transgender. I understand the struggles that members of the transgender community face. I know that it's not easy being transgender but I think it's so important to be true to yourself because in the end, you are the one who's going to make you happy. And the best way we can learn to fight for minority rights is by listening to members of said minority communities; its important to let minority communities voice themselves and allow them the space to do so.

The Miss Montana USA competition takes place in Missoula, Montana, on Sept. 9 and 10. A public vote will propel one contestant through to the top 11 semi-finals round click through to have your say. Anita's pitch: "I would encourage the public to vote for me because they would be taking an active role in making history. There has never been an open transgender woman to win a state title within the United States. I would be honored to be the first!"

Continued here:
Anita Green Wants to Win the Miss Montana USA State Pageant This Weekend Here's Why That's a Big Deal - Cosmopolitan.com

Brittany J Harrison,1 Tara N Hilton,1 Raphal N Rivire,1 Zachary M Ferraro,13Raywat Deonandan,4 Mark C Walker13,5

1Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada; 2Division of Maternal-Fetal Medicine, University of Ottawa, The Ottawa Hospital, Ottawa, ON, Canada; 3Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, ON, Canada; 4University of Ottawa Interdisciplinary School of Health Sciences, Ottawa, ON, Canada; 5Department of Obstetrics, Gynecology and Newborn Care, The Ottawa Hospital, Ottawa, ON, Canada

Objectives: This review explores the ethical and medical challenges faced by women of advanced maternal age who decide to have children. Assisted reproductive technologies (ARTs) make post-menopausal pregnancy physiologically plausible, however, one must consider the associated physical, psychological, and sociological factors involved.Methods: A quasi-systematic review was conducted in PubMed and Ovid using the key terms post-menopause, pregnancy + MeSH terms [donations, hormone replacement therapy, assisted reproductive technologies, embryo donation, donor artificial insemination, cryopreservation]. Overall, 28 papers encompassing two major themes (ethical and medical) were included in the review.Conclusion: There are significant ethical considerations and medical (maternal and fetal) complications related to pregnancy in peri- and post-menopausal women. When examining the ethical and sociological perspective, the literature portrays an overall positive attitude toward pregnancy in advanced maternal age. With respect to the medical complications, the general consensus in the evaluated studies suggests that there is greater risk of complication for spontaneous pregnancy when the mother is older (eg, >35 years old). This risk can be mitigated by careful medical screening of the mother and the use of ARTs in healthy women. In these instances, a woman of advanced maternal age who is otherwise healthy can carry a pregnancy with a similar risk profile to that of her younger counterparts when using donated oocytes.

Keywords: maternal age, medical, ethical, assisted reproduction, menopause

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Advanced maternal age: ethical and medical considerations for assisted reproductive technology - Dove Medical Press

The 45th presidents recent tweets banning transgender people from serving in the military because of their potential medical costs underscores the difficulties the transgender community faces in accessing quality health care. They often face stigma and discrimination by health professionals, and even if they have insurance, they may not have coverage for gender affirming procedures like hormone replacement therapy (HRT) or sex affirming surgery (SAS).

On some insurance plans, including Maryland Medicaid, prior authorization is required for someone who is transgender to receive HRT or SAS. Prior authorization is typically used to confirm that extraordinary requests are medically necessary, like transplants or cosmetic surgery. The transgender community shouldnt have to ask permission and submit claims before receiving life-affirming care.

According to the World Professional Association for Transgender Health, the standards of care for the transgender community include psychotherapy, HRT, changes in gender expression and SAS. Individuals may choose to use all, some or none of these in their health management of gender expression. These are particular therapeutic needs for this population. Although there may be some overlap with cisgender people (those whose personal gender identity corresponds with their birth sex) like psychotherapy, prostate exams and mammograms it is unethical to require preauthorization for other care that is specific to a community because it is different from the majority.

Currently the Affordable Care Act does not exclude the transgender population from some medically necessary care based on gender identity. This means a man can get insurance coverage for a pap smear, but not HRT. The language in the act is ciscentric, and wasnt specific enough to make insurance companies provide coverage for HRT and SAS. Even the quality metrics Maryland uses for its insurance plans do not include sexual orientation and gender identity information. So people in the community who are shopping for private insurance have no way of knowing if their care is covered in benefit plans. Transgender people have not been given a seat at the table in health care decision-making.

Fortunately, as a state, we can shift insurance coverage to include transgender specific care starting with Medicaid. Coverage under Medicaid would give the most vulnerable population access to quality care: 26 percent of the transgender population lives under the federal poverty line ($12,060 for individuals per year). Poverty in this community leaves people susceptible to violence, drug abuse and depression. Providing this population with access to life affirming care through Medicaid would set an example for private insurance plans to start allowing trans-specific health coverage.

This small step toward transgender insurance parity under Medicaid offers huge opportunities for the community in the health care field and beyond. There would be more understanding of hormone therapy and its side effects, long-term effects and dosing. Visibility in the health care arena can transition bias and discrimination among providers to compassion and understanding. Shifts in provider perception will result in the quality care needed to address the mental illnesses, housing instability and drug abuse that runs in the community. The increased demand to address those needs could transform into a specialized field of transgender health. The possibilities are endless.

California already mandates insurance coverage for life-affirming care in the transgender community. No significant changes were made to their budget for the accommodation, and insurance surcharges on private insurances were actually dropped because there was no significant cost for adding trans-specific care to their benefits.

Every year the transgender community becomes more and more visible; we are doing them a great disservice by ignoring their needs for health care specific to their community. We can take these steps of social progress and apply it on a national level and provide access to quality health care to all Americans.

Chigo Oguh (coguh@umaryland.edu) is a graduate student at the University of Maryland, Baltimore.

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Md. Medicaid should cover trans-specific care - Baltimore Sun