\n<\/p>\n
Estrogen-related medications for menopause will no longer carry broad black-box warnings, Marty Makary, commissioner of the US Food and Drug Administration (FDA), announced last week, bypassing the regulatory agency\u2019s typical process and, according to experts, overstating the science behind the medications \u2013 with troubling implications for future drug decisions.<\/p>\n
The decision to remove an ominous warning from 2003 about the risks of cardiovascular disease, breast cancer and dementia makes sense for local vaginal estrogen products, but systemic estrogen is more complicated, menopause experts said \u2013 and more than these nuances, they worried about the scientific process, or lack thereof, in making the decision.<\/p>\n
Hormone therapy can ease symptoms of menopause, including hot flashes, insomnia and joint pain. But health officials took claims of the benefits a major step forward, indicating the therapy can also prevent heart disease, osteoporosis, Alzheimer\u2019s disease and death.<\/p>\n
\u201cThere may be no other medication in the modern era that can improve the health outcomes of women on a population level than hormone replacement therapy,\u201d Makary said, calling it a \u201clife-changing, even life-saving treatment\u201d and positioning the announcement as a \u201cmedical breakthrough\u201d.<\/p>\n
Other officials at the press conference offered similarly rosy perspectives.<\/p>\n
Hormone therapy is \u201cextending the lives for as much as 10 years\u201d, said Robert F Kennedy Jr, secretary of the US Department of Health and Human Services (HHS).<\/p>\n
\u201cToday, we have the opportunity to add up to a decade of healthy years to the life of every woman that you love,\u201d said Alicia Jackson, head of the Advanced Research Projects Agency for Health and founder of Evernow, a startup that provides virtual menopause care. \u201cEstrogen is one of the most effective longevity interventions for women.\u201d<\/p>\n
Yet there is no evidence that hormone therapy has benefits among the wider population of menopausal women beyond those who have symptoms, researchers said.<\/p>\n
\u201cTo make that blanket statement that every woman should take this to prevent heart disease \u2013 it\u2019s not true,\u201d said Lauren Streicher, clinical professor of obstetrics and gynecology and founding medical director of the Center for Sexual Medicine and Menopause at the Northwestern University school of medicine.<\/p>\n
The \u201cdata-free\u201d decision sends a \u201charmful\u201d and confusing message, said Pauline Maki, professor of psychiatry, psychology and obstetrics and gynecology at the University of Illinois college of medicine.<\/p>\n
\u201cWomen are trying desperately to get the truth, and they\u2019re having a really difficult time,\u201d she said. When it comes to using menopause hormone therapy for dementia, her area of expertise, \u201cthe harm is maybe real, but certainly it\u2019s not showing benefit\u201d.<\/p>\n
An HHS spokesperson said that \u201crandomized studies show that women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures\u201d.<\/p>\n
The HHS did not respond to questions about officials\u2019 statements on purported protection against dementia and other issues or the evidence for using the medications widely.<\/p>\n
This is the first time the FDA has relied on a roundtable panel, which was not open to public comments in advance, to inform their regulatory decision-making, according to Pink Sheet. Streicher, who has long advocated for changes to the black-box warning, was going to be on the panel in July, but after a few preliminary meetings, she dropped out.<\/p>\n
\u201cIt became very clear to me that this was not going to be a scientific panel. This isn\u2019t the scientific approach,\u201d she said. \u201cI said: \u2018I\u2019m out. I don\u2019t want any part of this.\u2019\u201d<\/p>\n
Streicher attended the press conference earlier this month. \u201cThey were trying to get people to pack the room,\u201d she said. The organizers urged attendees to wear their white coats to give the event the imprimatur of expertise, Streicher said. She didn\u2019t.<\/p>\n
She says she\u2019s worried about the precedent set by the decision. The agency is also re-examining medications like mifepristone, which is a safe and effective medication for abortion.<\/p>\n
\u201cIt was very clear that Makary already had an agenda, that he was going to want to remove these labels, and was just kind of doing this public discourse of passionate people saying: \u2018This is why it should happen,\u2019\u201d she said. \u201cThey handpick the people who they know are going to say what they want them to say.\u201d<\/p>\n
Makary\u2019s most recent book has a chapter on hormone replacement therapy, titled OMG HRT, arguing that hormone therapy has been shown to \u201cincrease a woman\u2019s longevity by three years\u201d. The more accepted medical term for the treatment for women over 40 is menopause hormone therapy (MHT). The July panel included researchers who have published on menopause as well as doctors with large social media followings; no oncologists participated.<\/p>\n
The process involved letting panelists \u201cexpress their opinions\u201d, Makary said, followed by a literature review at FDA and the recommendation to \u201cremove certain blackbox warnings\u201d, which Makary himself signed.<\/p>\n
Typically, expert advisory committees hold public discussions on the evidence and then make recommendations to the FDA, which subject-matter experts at the agency \u2013 rarely the commissioner \u2013 may or may not accept.<\/p>\n
The FDA opted for the panel because advisory committee meetings are \u201cbureaucratic, long, often conflicted and very expensive\u201d, Makary said in response to a question about the process. More panels with guests who \u201c\u200b\u200bspeak [their] mind passionately\u201d will happen in the future, he added.<\/p>\n
The evidence itself on the medications is nuanced. Streicher notes \u201cthere\u2019s really two very separate issues, and they muddy those\u201d.<\/p>\n
Local vaginal estrogen, which is usually a cream, tablet, insert, suppository or vaginal ring, treats symptoms like dryness and irritation as well as recurrent urinary tract infections and urgency. \u201cThose products are really totally safe,\u201d Streicher said, adding that they never should have had the warning applied to them.<\/p>\n
Systemic estrogen is more complicated. There are many preparations, applications and ways it\u2019s metabolized. Some specific medications do have risks \u2013 oral estrogen, for example, increases the risk of getting a blood clot, while a transdermal patch doesn\u2019t. These labels need to be modified in a thoughtful, product-specific way, Streicher said. There\u2019s also a small increased risk of breast cancer with synthetic progesterone. The medications are not suitable for everyone, especially people with a history of breast or uterine cancer.<\/p>\n
Maki, a leading researcher on menopause and dementia, once believed memory issues could be linked to the loss of estrogen that occurs during menopause. Research indicated that women who used hormone therapy to treat menopause symptoms saw improvements to their memory. Maki conducted a large randomized study among a bigger group of menopausal women, not just those with symptoms.<\/p>\n
\u201cFar from showing benefit, it actually showed a trend toward harm,\u201d Maki said. Three other large randomized trials had similar results.<\/p>\n
Symptoms like hot flashes can be incredibly disruptive, with three-quarters of sufferers saying they have trouble sleeping \u2013 which can contribute to memory issues, especially over the course of seven or eight years.<\/p>\n
Maki now believes that treating those symptoms \u2013 whether with hormone therapy or other medications \u2013 is key to improving memory, as demonstrated in another study of hers with a non-hormonal treatment. To use hormone therapy for dementia prevention more widely is \u201cjust not based in science\u201d, Maki said.<\/p>\n
Yet in a \u201cstunning\u201d move, Maki said, health officials cherry-picked data from a small study in one community while ignoring larger randomized trials. Officials positioned the decision as a move against \u201cmedical group think\u201d and \u201cmedical dogma\u201d, as Makary put it.<\/p>\n
\u201cFor the first time in a generation, the FDA is standing with science and standing with women,\u201d said Kennedy. \u201cToday, we are restoring integrity to medicine, restoring faith in public health.\u201d<\/p>\n
The American medical establishment turned its back on women, said Kennedy, who recently sought to link women\u2019s use of Tylenol in pregnancy to autism. \u201cThe label was designed to frighten women and to silence doctors,\u201d Kennedy said, decrying \u201ca culture of fear\u201d.<\/p>\n
Makary said the decision was \u201cchallenging the paternalism of medicine\u201d, but then said hormone therapy \u201c\u200b\u200bhas saved marriages\u201d, indicating that one of the key outcomes of the medication is marital satisfaction.<\/p>\n
\u201cIt was not only scientifically wrong, but it was offensive,\u201d Streicher said.<\/p>\n
Hormone therapy is safe and effective for those with menopause symptoms, she said: \u201cBut do I tell every single woman who goes through menopause that she needs to be on hormone therapy? Absolutely not.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"
Estrogen-related medications for menopause will no longer carry broad black-box warnings, Marty Makary, commissioner of the US Food and Drug Administration (FDA), announced last week, bypassing the regulatory agency\u2019s typical process and, according to experts, overstating the science behind the medications \u2013 with troubling implications for future drug decisions. The decision to remove an ominous<\/p>\n","protected":false},"author":1,"featured_media":35010,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[51],"tags":[794,19810,83,366,17554,5824,3684,628,1933,81],"class_list":{"0":"post-35009","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health","8":"tag-administration","9":"tag-datafree","10":"tag-decision","11":"tag-doctors","12":"tag-hormone","13":"tag-menopause","14":"tag-respond","15":"tag-therapy","16":"tag-true","17":"tag-trump"},"_links":{"self":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/35009","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=35009"}],"version-history":[{"count":0,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/35009\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/media\/35010"}],"wp:attachment":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=35009"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=35009"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=35009"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}