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Tag: medication abortion

  • Fact-checking Florida AG on abortion pill hospitalizations

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    Florida Attorney General James Uthmeier is suing Planned Parenthood for what he called deceptive marketing practices involving abortion pills.

    In a Nov. 6 video on X, Uthmeier said Planned Parenthood “falsely marketed to women” that abortion pills are safer than over-the-counter medications.

    “Evidence suggests that 1 in 25 women who consume these dangerous pills are hospitalized,” Uthmeier said. “And we’ve seen dozens of reported deaths. This is wrong, and we’re going to hold them accountable.”

    Although Uthmeier used the word “hospitalized” to describe the outcome, text that appeared on screen in the video as he spoke said 1 in 25 women “end up in the ER,” a figure that combines results from two studies Uthmeier cited. Emergency department visits are not the same as hospitalizations, which involve patients being formally admitted. 

    When contacted for evidence, Uthmeier’s spokesperson pointed PolitiFact to a table in the U.S. Food and Drug Administration’s label for mifepristone, the first of two pills taken in early pregnancy for medication abortion. One line in the table said two U.S. studies with 1,043 women found a 2.9% to 4.6% frequency rate for ER visits. The higher end of the range roughly correlates to 1 in 25 women.

    Besides conflating hospitalizations and ER visits, Uthmeier cited studies with small sample sizes; multiple larger studies found lower rates of both ER visits and hospitalizations following medication abortion. Researchers told PolitiFact emergency department visits are not a reliable indicator of drug safety and are not proof that patients experienced serious adverse events or were admitted to the hospital.

    “In large studies of medication abortion, hospitalization is very rare, generally occurring in <0.5% of patients,” Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, wrote in an email to PolitiFact. Grossman said ER visits are more common because patients who do not live near their provider might have to go to an emergency department for anything that requires in-person consultation, including to confirm an abortion was successful. 

    The FDA label that Uthmeier cited also showed hospitalization rates of 0.04% to 0.06% among 14,339 women evaluated in three studies, or about 86 women on the higher end of the range.

    The FDA label does not include the research methodology or details about the cases. The FDA didn’t answer our questions about the studies.

    Danco Laboratories, which manufactures and distributes mifepristone under the brand name Mifeprex, provided the studies to PolitiFact. The two reports showed 41 women out of 1,043 visited the ER after taking abortion pills. Eight of the 41 were hospitalized and, of those, three were admitted for unrelated reasons, including pancreatitis and hip pain. That means five out of 1,043 women evaluated were hospitalized for reasons related to abortion pills.

    “The actual percentage of related serious adverse events that required hospital admission in these two studies was 0.5%,” said Ushma Upadhyay, a professor and public health scientist at the University of California, San Francisco.

    What is medication abortion and how safe is it?

    Medication abortion is approved in the U.S. up to the 10th week of pregnancy and involves two medicines — mifepristone and misoprostol — that are typically taken 24 hours apart. Studies have found that around 95% to 98% of patients who take the medicines as prescribed will end their pregnancies without  complication.

    The FDA has repeatedly reaffirmed mifepristone’s safety since the drug was first approved in 2000. (Misoprostol has been on the market longer and has different uses, including preventing stomach ulcers.)

    Medication abortions are common, accounting for 63% of all abortions in the U.S. in 2023, according to the Guttmacher Institute, a research organization that supports reproductive rights. More than 5 million women in the U.S. have used abortion pills to terminate pregnancies.

    Over 100 studies spanning decades have found medication abortion to be safe and effective. 

    “We’ve been using mifepristone in the U.S. for over two decades and we aren’t seeing legitimate studies that are documenting any medical fallout or medical complications from this drug,” said Rachel Jones, Guttmacher Institute principal research scientist.

    Medication abortion and ER visits, hospitalizations

    Research shows abortion pills are not associated with a high percentage of emergency room visits or hospitalizations.

    The studies Uthmeier pointed to did not prove that medication abortion is dangerous, experts said

    One of the studies, published in 2012, acknowledged that major adverse events attributable to medication abortion, such as hospitalizations, emergency department visits and blood transfusions, are “rare.” 

    The vast majority of mifepristone research is in line with this.   

    A 2013 study that examined 233,805 medication abortions by Planned Parenthood in 2009 and 2010 found an emergency department treatment rate of 0.1%, and said significant adverse events requiring hospital admission occurred in 0.16% of cases.

    A 2015 study on emergency room visits and complications after 55,000 abortions — 11,000 of which were medication abortions — found that serious adverse events occurred in 0.3% of all cases.

    Emergency department visits alone are not indicative of adverse events, Upadhyay, the 2015 study’s lead author, told PolitiFact.

    A 2018 study found around 51% of abortion-related ER visits involved observational care only. “This really shows that people go to the emergency department to have their questions answered. They aren’t getting any treatment. They are being observed and released,” Upadhyay said.

    U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary have promised to launch another mifepristone safety review. The top health officials have referenced studies that experts say have several problems.

    For example, one April report by the Ethics and Public Policy Center, a conservative nonprofit that opposes abortion, found a substantially higher rate of serious side effects from the drug compared with other studies.

    The report wasn’t peer-reviewed or published in a medical journal. It didn’t disclose its data source and contained multiple methodological issues, 263 reproductive health researchers wrote in a letter to the FDA. Uthmeier cites the report in Florida’s lawsuit against Planned Parenthood.

    Our ruling

    Uthmeier said, “Evidence suggests that 1 in 25 women who consume (abortion) pills are hospitalized.”

    Uthmeier conflated hospitalizations with emergency department visits. Roughly 1 in 25 women visited the ER in the two studies Uthmeier cited, but only five out of 1,043 — or 1 in 200 — were hospitalized related to the abortion pill.

    ER visits, which can often involve only observational care followed by release, are not a reliable indicator of drug safety, researchers said, and do not mean patients experienced a serious adverse event or were admitted to the hospital.

    Several other studies found lower rates of ER treatment and hospitalizations following medication abortion.

    Uthmeier’s statement contains an element of truth but ignores critical facts that would give a different impression. We rate it Mostly False.  

    PolitiFact Researcher Caryn Baird contributed to this report.

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  • Supreme Court says abortion pill mifepristone will remain broadly available during legal battle

    Supreme Court says abortion pill mifepristone will remain broadly available during legal battle

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    Demonstrators rally in support of abortion rights at the US Supreme Court in Washington, DC, April 15, 2023. 

    Andrew Caballero-Reynolds | AFP | Getty Images

    The Supreme Court on Friday ordered the abortion pill mifepristone to remain broadly available as litigation plays out in a lower court.

    The high court’s decision came in response to an emergency request by the Department of Justice to block lower court rulings that would severely limit access to the medication even in some states where abortion remains legal. 

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    The case will now be heard in the U.S. 5th Circuit Court of Appeals. The appeals court has scheduled oral arguments for Wed., May 17 at 1 p.m. CT.

    Mifepristone has become the flashpoint in the legal battle over abortion since the Supreme Court last summer overturned Roe v. Wade, the landmark 1973 decision that guaranteed abortion nationwide as a constitutional right. 

    Mifepristone, used in combination with another drug called misoprostol, is the most common method to terminate a pregnancy in the U.S., accounting for about half of all abortions.

    President Joe Biden said the court’s decision keeps mifepristone available to women and FDA approved to terminate early pregnancies. Biden said his administration will fight to protect access to mifepristone in the ongoing legal battle in the 5th Circuit Court of Appeals.

    “I continue to stand by [the Food and Drug Administration’s] evidence-based approval of mifepristone, and my administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs,” the president said.

    Planned Parenthood President Alexis McGill Johnson said the reproductive health-care provider is relieved by the Supreme Court’s decision.

    But McGill Johnson warned that access to  mifepristone remains in jeopardy as the legal battle plays out in the appeals court.

    “While mifepristone’s approval remains intact and it stays on the market for now, patients and health care providers shouldn’t be at the mercy of the court system,” McGill Johnson said. “Medication abortion is very much still under threat — as is abortion and access to other sexual and reproductive health care.”

    Justices Samuel Alito and Clarence Thomas, both conservatives, opposed the court’s majority decision to grant the emergency request from the DOJ and Danco Laboratories, the distributor of the brand-name version of the drug, Mifeprex.

    The DOJ and Danco, in their emergency requests, told the Supreme Court the restrictions imposed by the lower courts would effectively take mifepristone off the market for months as the FDA adjusted the medication’s labelling to comply with the orders. This would deny women access to an FDA-approved drug that is a safe alternative to surgical abortions, they argued.

    Alito rejected that argument in his dissent. The justice said the FDA could simply use its enforcement discretion as the litigation played out and allow Danco to continue distributing mifepristone.

    The court’s majority decision to maintain the status quo means mifepristone remains available by mail delivery, and women can obtain the prescription medication without having to visit a doctor in person.

    However, in the dozen states that have effectively banned abortion over the past year, the drug will remain largely unavailable. Other states also have restrictions in place that are much tighter than FDA regulations.

    The national legal battle over mifepristone began with a lawsuit filed by a coalition of doctors who oppose abortion, the Alliance for Hippocratic Medicine. Those doctors sought to force the FDA to pull the medication from the U.S. entirely.

    Earlier this month, U.S. District Judge Matthew Kacsmaryk ruled in favor of the antiabortion doctors and issued a sweeping order that would have halted sales of mifepristone nationwide. 

    Days later, the U.S. Fifth Circuit Court of Appeals blocked part of Kacsmaryk’s order and allowed Mifeprex to remain on the market. But the appeals court judges imposed restrictions on the medication that would severely limit access.

    The appeals court blocked mail delivery of the drug, imposed doctors’ visits as a condition to get the medication, and reduced the length of time when women can take the pill to the seventh week of pregnancy. 

    The appeals court judges also suspended the 2019 approval of the generic version of mifepristone. The company that sells the generic version, GenBioPro, told the high court the majority of the nation’s supply of the medication would “disappear overnight” if the appeals court ruling went into effect. 

    GenBioPro said it supplies two-thirds of the mifepristone used in abortions in the U.S.

    CNBC Health & Science

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  • The Other Abortion Pill

    The Other Abortion Pill

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    In the months since the Supreme Court overturned Roe v. Wade, demand for medication abortion has soared. The method already accounted for more than half of all abortions in the United States before the Court’s decision; now reproductive-rights activists and sites such as Plan C, which shares information about medication abortion by mail, are fielding an explosion in interest in abortion pills. As authorized by the FDA, medication abortion consists of two drugs. The first one, mifepristone, blocks the hormone progesterone, which is necessary for a pregnancy to continue. The second, misoprostol, brings on contractions of the uterus that expel its contents. The combination is, according to studies conducted in the U.S., somewhere between 95 percent and 99 percent effective in ending a pregnancy and is extremely safe.

    The second drug, misoprostol, can also safely end a pregnancy on its own. That method has long been considered a significantly less effective alternative to the FDA-approved protocol. But a growing body of research has begun to challenge the conventional thinking. In situations where people use pills to end a pregnancy at home, studies have found far higher rates of success for misoprostol-only abortions than were found in clinical settings. One recent study in Nigeria and Argentina showed misoprostol-only abortion to be 99 percent effective.

    Even before new restrictions began to ripple across the U.S., mifepristone—often referred to as “the abortion pill”—was tightly controlled by the FDA, which requires that the drug be dispensed only by doctors certified to prescribe it and only to patients who’ve signed an agency-approved agreement. As efforts to ban that drug intensify, the relative availability of misoprostol, which can be obtained at pharmacies in every state and prescribed by any doctor, could make misoprostol alone a more common option for women seeking abortions, legally or clandestinely.

    Read: The future of abortion in a post-Roe America

    Already, the Austria-based nonprofit Aid Access, which helps women in the U.S. order pills through the mail, helped thousands of women procure misoprostol-only regimens in the first months of the coronavirus pandemic, when shipments of mifepristone were disrupted. At least one U.S. abortion provider, Carafem, has been offering its patients a misoprostol-only option for close to two years, and other reproductive-health groups are now considering offering the same regimen. This approach follows a path that has been well established in places around the world, where mifepristone has been scarce or unavailable, but in the U.S., it represents a real shift in abortion provision.

    If in the past mifepristone has garnered the bulk of attention from politicians and the public in the U.S., that focus may owe in part to an oft-told story about the origins of “the abortion pill” and its lone inventor, the renowned French researcher Dr. Étienne-Émile Baulieu. The reality is that of the two drugs, misoprostol has always mattered more.

    For his work on mifepristone, Baulieu won one of the most prestigious prizes in medicine, whose recipients tend to be discussed as candidates for a Nobel Prize, and received France’s Legion of Honor. A lengthy profile in The New York Times Magazine called him “a different kind of scientist.” And though the chemists George Teutsch and Alain Belanger actually synthesized the compound, Baulieu became, to American audiences, “the father of the abortion pill.”

    Yet mifepristone is not, by itself, a highly effective abortifacient. Taken alone, the drug ends a pregnancy only about two-thirds of the time, which is why it has always been administered in combination with a prostaglandin—a drug that mimics the function of hormones that promote menstrual cramping and inflammation.

    For years, doctors in Europe had been administering mifepristone with a prostaglandin called sulprostone. The combination was nearly 100 percent effective, but required multiple in-person visits to a clinic or hospital because sulprostone could only be given by injection. “Everyone had been looking for a prostaglandin that didn’t have to be either injected or kept frozen,” says Beverly Winikoff, the founder of Gynuity Health Projects, whose research on medication abortion helped win FDA approval in the United States.

    In Brazil, women had already found one. No individual, or individuals, have ever been widely credited for that discovery, the way Baulieu is credited for mifepristone. But scholars agree that the practice began in the country’s impoverished northeast soon after the drug went on the market in 1986.

    Manufactured by G.D. Searle & Company, misoprostol was developed to treat stomach ulcers. To women in Brazil, where abortion was and remains severely restricted, the warning on the label, to avoid taking the drug while pregnant, advertised its potential as an abortifacient. And when they found the drug safer and more effective than other clandestine methods, misoprostol’s popularity exploded. (To state the obvious, no one should interpret drug warnings for pregnant people as covert advertisements for effective abortion alternatives.)

    Soon, doctors in Brazil reported seeing fewer women with severe abortion-related complications, and Brazilian researchers began documenting the drug’s off-label use. The first such study appeared in a 1991 letter to the editor of The Lancet: Helena Coelho and her colleagues at the University of Ceara had found that knowledge of misoprostol’s capacity to induce abortion had “spread rapidly” among both women and pharmacy personnel. But it had also reached government officials, who limited sales to authorized pharmacies and, in one state, banned misoprostol entirely.

    Read: Women in the U.S. can now get safe abortions by mail

    That same year, Baulieu, the French researcher, announced that he had devised a simpler way to use mifepristone—by combining it with misoprostol, which, unlike sulprostone, could be taken by mouth. Writing in The New England Journal of Medicine, Baulieu did reference misoprostol’s use in Brazil, but only as an example of what not to do. Citing anecdotal reports of cranial malformations in infants exposed to misoprostol in utero, he and colleagues claimed that administering misoprostol alone would risk “embryonic abnormalities,” adding that G.D. Searle “strongly disapproved” of the practice.

    The reports of cranial anomalies were never confirmed. But Searle did take pains to prevent the use of misoprostol for abortion, at one point publicly warning doctors in the U.S. against administering the drug to pregnant women. Over time, researchers established other important uses for misoprostol, such as treating miscarriage and preventing postpartum hemorrhage. Yet during the lifetime of its patent, the company refused to research or register the drug for any reproductive-health indication.

    Meanwhile, Brazilian newspapers had seized on the dangers that Baulieu had cited, fueling fears that failed abortions would create “a generation of monsters.” That in turn provided Brazilian authorities with a public-health rationale for regulating misoprostol as a controlled substance, the “possession or supply” of which carries penalties even more punitive than those for drug trafficking. But through informal networks, feminist activists continued helping women access both misoprostol and information about how to safely use it at home. More than three decades later, experts now credit Brazil as the birthplace of self-managed medication abortion.

    In the past few years, researchers have more formally documented what these informal networks established. In clinical trials, medication abortion with misoprostol alone was effective in completing first-trimester abortion roughly 80 percent of the time. As a rule, “We think about clinical-trials data as the gold standard,” says Caitlin Gerdts, a vice president at Ibis Reproductive Health and a senior author on the study in Nigeria and Argentina. Yet when researchers have examined misoprostol’s use in nonclinical settings, they have found far higher rates of success, with 93 to 100 percent of participants reporting complete abortions using only misoprostol. Given the many studies showing high effectiveness in self-managed settings, Gerdts says, “I think it’s time to reconsider the idea of the clinical trials data as being paramount.”

    One reason for the greater effectiveness of misoprostol alone in studies of self-managed abortion may have to do with how the studies were designed. “The problem with clinical trials is that often when we ask somebody to follow up in a week or two weeks, the body hasn’t had enough time to expel all of the products of conception,” says Dr. Angel Foster, a health-science professor at the University of Ottawa, whose work on the Thailand-Myanmar border was the first to rigorously investigate the effectiveness of misoprostol alone for abortion outside a formal health system. “If there’s a smudge on an ultrasound, it’s not that there’s a continuing pregnancy—it’s just debris. But rather than let the uterus absorb it or expel it, we do an evacuation procedure and we count it as a failure.” In studies of self-managed abortion, she says, the follow-up period tends to be longer—three or four weeks—and surgical intervention may not always be an option.

    “I do think because of the way it’s been treated in clinical trials, misoprostol has been defined as much less effective than we now believe it to be,” Foster says. “We talk about mifepristone as ‘the abortion pill,’ but I think it’s more appropriate to think of it as a pretreatment or an adjunct therapy. Because it’s really the misoprostol that’s doing the lion’s share of the work.”

    Elizabeth Raymond, a senior medical associate at Gynuity and the lead author of a systematic review of clinical trials on the use of misoprostol alone for early abortion, acknowledges that the clinical studies may have been too quick to intervene. But she says the shorter follow-up period was not without reason. Using ultrasound and a blood test to measure the amount of hCG, or human chorionic gonadotropin, doctors can diagnose a complete abortion “quite quickly, certainly within one or two weeks,” she says, “and the researchers wanted to do the assessments as soon as reasonable. They saw no sense in delaying.” Raymond suspects that misoprostol alone isn’t quite as effective as reported in the study in Nigeria and Argentina, in part because that study relied on its subjects to self-report whether the abortion was complete. “I think it’s an intriguing study, and it’s true that misoprostol alone is more effective than we thought,” she says, “but I think the general feeling is, if you can get both drugs, you should do that. The combination is more effective, and it may cause less cramping and bleeding.”

    Those side effects aren’t a safety concern, says Dr. Julie Amaon, the medical director of Just the Pill, which delivers abortion medication to people in Wyoming, Montana, Colorado, and Minnesota. “But it’s something to keep in mind,” she says, adding that anyone self-managing an abortion at home should adhere to the WHO-recommended protocol and follow up with a doctor, whether in person, by phone, or by text, to ensure that the process is complete. In the U.S., the FDA has approved only the two-drug regimen; although the WHO’s recommendations also suggest a preference for medication abortion with both drugs, that agency does recommend misoprostol-only abortion “in settings where mifepristone is not available.”

    Read: The abortion pill can be used later than the FDA says

    Right now, lawmakers across the U.S. are working to put both drugs out of reach. Fourteen states now fully or partially ban both mifepristone and misoprostol. Of the two drugs, though, misoprostol is still more easily obtained, either by prescription in pharmacies or via nonprofit groups in the U.S. and overseas. The Biden administration has said that it intends to maintain access to medication abortion, but so far has not acted to ease the stricter regulations on mifepristone. As long as those restrictions remain in place, ending a pregnancy with misoprostol alone could become a more common choice for people with few options.

    According to the Guttmacher Institute, a reproductive-health-research group that supports abortion rights, though the rate is difficult to measure, in the past self-managed abortions probably haven’t occurred in the U.S. on a large scale. But as conditions in red states come to resemble those in Brazil, the practice could become more and more common. In this way, says Mariana Prandini Assis, a Brazilian social scientist who has written extensively on abortion, the fall of Roe may well lead to the normalization in America of self-managed abortion with pills—a choice once thought of as a last resort or an act of desperation. For that reason, she says, the Brazilian women who pioneered the use of misoprostol for abortion should be considered the “other inventors of ‘the abortion pill.’”

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