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Confusion over maternal care medication plagues politics in Louisiana and beyond

Confusion over maternal care medication plagues politics in Louisiana and beyond

Yahoo2 days ago

Packages of Mifepristone tablets are displayed at a family planning clinic on April 13, 2023, in Rockville, Maryland. (Photo illustration by)
A year ago, Gov. Jeff Landry signed a bill into law that made Louisiana the first state in the country to reclassify pregnancy care drugs as controlled dangerous substances. Since then, the political assault on the medications has continued to ramp up on the state and national level.
The Louisiana law to reclassify mifepristone and misoprostol caused controversy, particularly when multiple medical professionals publicly criticized the measure saying the added burdens to accessing the medications could delay medical treatment in times of crisis.
Misoprostol and mifepristone have been targeted because they are used in medication abortion, but both have multiple other uses. Misoprostol is used to prevent and treat postpartum hemorrhage. Since the state law went into effect in October, hospitals have changed how they store and dispense the drugs, locking them up in passcode-protected storage containers outside of labor and delivery rooms.
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The New Orleans Health Department has been tracking complaints from health care providers and patients who have struggled with misoprostol access since October. The medical professionals and patients were provided anonymity to encourage feedback.
One doctor wrote they had trouble accessing the drug to provide to a patient going through a hysteroscopy, a medical procedure in which the doctor examines a woman's uterus using a thin, lighted tube.
'I was unable to get misoprostol in pre-op for [a] patient undergoing hysteroscope,' the provider wrote. 'Therefore [I] had to manually dilate [the] cervix multiple times causing unnecessary harm to the patient.'
Another doctor said they couldn't complete a biopsy, so they prescribed misoprostol to a patient in order to try the procedure again after softening her cervix. The doctor included the patient's diagnosis of abnormal bleeding on the prescription, and that the patient was not pregnant. The pharmacy refused to fill the prescription until the doctor got on the phone to confirm the medication was not being used to end a pregnancy.
'This could lead to a delay in diagnosis of cancer,' the doctor wrote.
In another instance, a pharmacist refused to fill a prescription for misoprostol ahead of an IUD insertion, telling the patient 'he thought she was going to use it for an abortion,' wrote the doctor.
There were also multiple accounts of misoprostol being prescribed for miscarriages, but pharmacists delayed filling prescriptions until they spoke to the doctor on the phone. In one instance, the mother who miscarried filed a complaint with the city health department.
'I was denied misoprostol, essentially leaving me with my dead baby inside of me even longer because the pharmacist said he couldn't give it to me,' the mother wrote. 'It was more horrific than it needed to be.'
Even among state lawmakers who approved the law, confusion reigns.
At a Louisiana House committee hearing last month, Rep. Lauren Ventrella, R-Greenwell Springs, said that last year 'we made it illegal to prescribe' mifepristone and misoprostol. However, both can still be legally prescribed by health care providers with the proper licensing for Schedule IV drugs. When the law reclassifying the medication passed, its supporters repeatedly stated they were not restricting access to the medication for people who needed it for reasons outside of abortion.
When Ventrella misspoke, she was introducing House Bill 575, which would allow families to sue over suspected abortions. Attorney General Liz Murrill has referred to the law as 'another tool in the toolbox' that could be used against out-of-state doctors who prescribe abortion medication to patients in Louisiana.
Murrill is currently prosecuting at least two cases involving a New York doctor who allegedly prescribed medications to pregnant women in Louisiana. So far, New York's shield laws, which protects abortion providers, have held up against states that have tried to prosecute doctors.
Ventrella's bill awaits Senate floor action with less than a week remaining in the legislative session.
Opponents of the reclassification of mifepristone and misoprostol have worried that, by labeling the drugs as controlled dangerous substances, it would confuse medical providers and the public as well as stigmatize medications that have been proven to be safe and effective. They are challenging the law, Act 246, in state court, and a judge ruled May 15 that the plaintiffs suing the state have a right to pursue their case.
'Specifically, the judge agreed that the plaintiffs have sufficiently demonstrated the harm that the law is causing to their practice, and the patients that they serve, to be able to challenge the constitutionality of this law,' said Ellie Schilling, a New Orleans attorney representing the plaintiffs.
The plaintiffs include the reproductive health advocacy group Lift Louisiana, the Birthmark Doula Collective and multiple women's health advocates and Louisiana health care providers, including OB-GYNs, midwives and pharmacists.
As the court fight plays out in Louisiana, another clash is occurring on the national stage.
U.S. Health Secretary Robert F. Kennedy Jr. has ordered the Food and Drug Administration to conduct a 'complete review' on misoprostol and mifepristone. It comes in the wake of a far-right organization publishing a paper — one that is not peer-reviewed and many critics view as unscientific — claiming the drugs cause adverse medical effects.
The far-right think tank, the Ethics and Public Policy Center, claimed almost 11% of women experienced a 'serious adverse event' from the medications, but peer-reviewed clinical studies have shown an overall 0.5% rate of serious adverse events. Other research in the report also doesn't hold up to fact-checking, and its authors did not reveal where they sourced the data that was cited.
'It's deeply troubling that Secretary Kennedy is elevating junk-science to justify reopening mifepristone's safety review, especially at the behest of anti-abortion political operatives,' said Dr. Angel Foster, co-founder of the Massachusetts Abortion Access Project, which provides medication abortion care to all 50 states via telemedicine. 'I know firsthand that mifepristone's safety is backed by decades of rigorous data. Rolling back access to mifepristone would be a disaster.'
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The attorneys general of four Democrat-led states—New York, New Jersey, Massachusetts, and California—petitioned the Food and Drug Administration on Thursday, June 5, asking the agency to lift what they view as unnecessary restrictions on the abortion pill mifepristone. The petition aims to force the FDA to acknowledge robust clinical evidence and decades of mifepristone use that support the drug's safety and efficacy. The move comes just one month after Health and Human Services Secretary Robert F. Kennedy Jr. told Congress that he ordered a safety review of the abortion pill. An FDA spokesperson confirmed plans for the review in a statement to CBS News on Tuesday, June 3. According to the FDA, mifepristone, approved by the regulator in 2000, is a drug that blocks the hormone progesterone, which is necessary for pregnancy to continue. It is most commonly used in combination with the drug misoprostol to terminate a pregnancy within 10 weeks of gestation. An analysis of 2023 data by the Guttmacher Institute found that medication abortions account for more than half (63%) of all abortions in the U.S. But in the years since the Supreme Court overturned Roe v. Wade, 17 states have banned this medication, and an additional 10 states have placed restrictions on it, according to the Washington Post. 'The medication is a lifeline for millions of women who need access to time-sensitive, critical healthcare—especially low-income women and those who live in rural and underserved areas,' California attorney general Rob Bonta told the Los Angeles Times. The petition specifically asks the FDA to lift the mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. This additional regulatory framework is designed to 'help ensure the benefits of the medication outweigh its risks,' according to the FDA. REMS has been applied to 325 medications since its inception and currently applies to 71 drugs. REMS places multiple restrictions on mifepristone use, including that prescribers be put on national and local abortion provider lists; patients give written statements that they intend to end their pregnancies; and pharmacies keep records of mifepristone prescribers and users. The attorneys general argue that these rules 'impose unnecessary and burdensome hurdles on patients, prescribers, pharmacists, and the healthcare system.' They also point out that mifepristone has been marketed in the U.S. for decades and has been safely used by more than 7.5 million American women. 'Moreover, no new evidence raising safety concerns has emerged in the last two decades,' they state. These states are not alone in their pursuit of expanded mifepristone access. Seventeen other Democratic-led or -leaning states, plus Washington D.C., are suing the FDA in Spokane, Washington, to loosen restrictions on the drug, Reuters reported in February. What's more, leading medical organizations have called on the FDA to remove REMS restrictions on mifepristone for years. If the FDA declines to remove REMS, Thursday's petition asks the agency to 'exercise its discretion not to enforce' some or all of the restrictions in New York, New Jersey, Massachusetts, and California, as these states already place 'rigorous restrictions' around the practice of medicine.

Confusion over maternal care medication plagues politics in Louisiana and beyond
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Packages of Mifepristone tablets are displayed at a family planning clinic on April 13, 2023, in Rockville, Maryland. (Photo illustration by) A year ago, Gov. Jeff Landry signed a bill into law that made Louisiana the first state in the country to reclassify pregnancy care drugs as controlled dangerous substances. Since then, the political assault on the medications has continued to ramp up on the state and national level. The Louisiana law to reclassify mifepristone and misoprostol caused controversy, particularly when multiple medical professionals publicly criticized the measure saying the added burdens to accessing the medications could delay medical treatment in times of crisis. Misoprostol and mifepristone have been targeted because they are used in medication abortion, but both have multiple other uses. Misoprostol is used to prevent and treat postpartum hemorrhage. Since the state law went into effect in October, hospitals have changed how they store and dispense the drugs, locking them up in passcode-protected storage containers outside of labor and delivery rooms. SUBSCRIBE: GET THE MORNING HEADLINES DELIVERED TO YOUR INBOX The New Orleans Health Department has been tracking complaints from health care providers and patients who have struggled with misoprostol access since October. The medical professionals and patients were provided anonymity to encourage feedback. One doctor wrote they had trouble accessing the drug to provide to a patient going through a hysteroscopy, a medical procedure in which the doctor examines a woman's uterus using a thin, lighted tube. 'I was unable to get misoprostol in pre-op for [a] patient undergoing hysteroscope,' the provider wrote. 'Therefore [I] had to manually dilate [the] cervix multiple times causing unnecessary harm to the patient.' Another doctor said they couldn't complete a biopsy, so they prescribed misoprostol to a patient in order to try the procedure again after softening her cervix. The doctor included the patient's diagnosis of abnormal bleeding on the prescription, and that the patient was not pregnant. The pharmacy refused to fill the prescription until the doctor got on the phone to confirm the medication was not being used to end a pregnancy. 'This could lead to a delay in diagnosis of cancer,' the doctor wrote. In another instance, a pharmacist refused to fill a prescription for misoprostol ahead of an IUD insertion, telling the patient 'he thought she was going to use it for an abortion,' wrote the doctor. There were also multiple accounts of misoprostol being prescribed for miscarriages, but pharmacists delayed filling prescriptions until they spoke to the doctor on the phone. In one instance, the mother who miscarried filed a complaint with the city health department. 'I was denied misoprostol, essentially leaving me with my dead baby inside of me even longer because the pharmacist said he couldn't give it to me,' the mother wrote. 'It was more horrific than it needed to be.' Even among state lawmakers who approved the law, confusion reigns. At a Louisiana House committee hearing last month, Rep. Lauren Ventrella, R-Greenwell Springs, said that last year 'we made it illegal to prescribe' mifepristone and misoprostol. However, both can still be legally prescribed by health care providers with the proper licensing for Schedule IV drugs. When the law reclassifying the medication passed, its supporters repeatedly stated they were not restricting access to the medication for people who needed it for reasons outside of abortion. When Ventrella misspoke, she was introducing House Bill 575, which would allow families to sue over suspected abortions. Attorney General Liz Murrill has referred to the law as 'another tool in the toolbox' that could be used against out-of-state doctors who prescribe abortion medication to patients in Louisiana. Murrill is currently prosecuting at least two cases involving a New York doctor who allegedly prescribed medications to pregnant women in Louisiana. So far, New York's shield laws, which protects abortion providers, have held up against states that have tried to prosecute doctors. Ventrella's bill awaits Senate floor action with less than a week remaining in the legislative session. Opponents of the reclassification of mifepristone and misoprostol have worried that, by labeling the drugs as controlled dangerous substances, it would confuse medical providers and the public as well as stigmatize medications that have been proven to be safe and effective. They are challenging the law, Act 246, in state court, and a judge ruled May 15 that the plaintiffs suing the state have a right to pursue their case. 'Specifically, the judge agreed that the plaintiffs have sufficiently demonstrated the harm that the law is causing to their practice, and the patients that they serve, to be able to challenge the constitutionality of this law,' said Ellie Schilling, a New Orleans attorney representing the plaintiffs. The plaintiffs include the reproductive health advocacy group Lift Louisiana, the Birthmark Doula Collective and multiple women's health advocates and Louisiana health care providers, including OB-GYNs, midwives and pharmacists. As the court fight plays out in Louisiana, another clash is occurring on the national stage. U.S. Health Secretary Robert F. Kennedy Jr. has ordered the Food and Drug Administration to conduct a 'complete review' on misoprostol and mifepristone. It comes in the wake of a far-right organization publishing a paper — one that is not peer-reviewed and many critics view as unscientific — claiming the drugs cause adverse medical effects. The far-right think tank, the Ethics and Public Policy Center, claimed almost 11% of women experienced a 'serious adverse event' from the medications, but peer-reviewed clinical studies have shown an overall 0.5% rate of serious adverse events. Other research in the report also doesn't hold up to fact-checking, and its authors did not reveal where they sourced the data that was cited. 'It's deeply troubling that Secretary Kennedy is elevating junk-science to justify reopening mifepristone's safety review, especially at the behest of anti-abortion political operatives,' said Dr. Angel Foster, co-founder of the Massachusetts Abortion Access Project, which provides medication abortion care to all 50 states via telemedicine. 'I know firsthand that mifepristone's safety is backed by decades of rigorous data. Rolling back access to mifepristone would be a disaster.' SUPPORT: YOU MAKE OUR WORK POSSIBLE

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