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"Abortion drugs" can treat dozens of illnesses, but Roe's reversal can confuse research

Dr. Nancy Klimus has spent most of her 30-year research career finding cures for Gulf War illnesses. Military veterans with an unusual and unexplained illness affecting approximately 300,000 U.S. soldiers who fought in the 1991 Desert Storm Operation suffered constant pain, pain, loss of concentration, and fatigue. I suffer from a variety of symptoms, including sensation, respiratory problems, and irritable bowel syndrome. It is understood that bowel syndrome, all due to exposure to neurotoxic chemicals during combat.

There is no cure for the Gulf War illness, except for symptom management (she says it's really just "chasing the dog's tail"). And the clock is ticking. If left untreated, the condition can turn into a severe neurodegenerative disease, according to Klimus, director of the Institute of Neuroimmunology, University of Nova Southeastern Florida.

"I'm anxious to get there as soon as possible and help these veterans," said Klimus, director of the Environmental Medicine Research Program at the Miami Veterans Medical Center. "It's been thirty years now." 

Now she hopes this help will finally come in a clinical trial of a male veteran launched at the Miami Veterans Hospital. In this study, she tests a combination of the two drugs. Both have already been approved by the Food and Drug Administration for a variety of uses.

Dr. Nancy Klimas.
Dr. Nancy Klimus.Courtesy Dr. NancyKlimas

One is the arthritis drug etanercept or enbrel. The other is mifepristone —well known as an abortion drug

The first to bring some relief to these veterans if a successful clinical trial is successful. Klimus expects it to be a step. However, as theSupreme Court overturned the legal rights to abortion established in the Roe v. Wade case, researchers studying mifepristone for non-abortion uses have their own set. You may face challenges.

Versatile drug 

Since being approved by the FDA in 2000, mifepristone and misoprostol tablets have been safe for women. It is an effective option. Ask for an abortion in the first 10 weeks of pregnancy. Mifepristone is currently used in more than half of abortions in the United States, according to the Guttmacher Institute, a research group that supports the right to abortionThe drug is a hormone required for pregnancy growth Blocks progesterone, which is. Misoprostol causes spasms and bleeding, emptying the uterus.

Mifepristone and Misoprostol
Combination pack of mifepristone and misoprostol tablets, used together for drug abortion 2 Two medicines.Elisa Wells / Getty Images File C / AFP Planning

Mifepristone is best used indrug-induced abortionAs is known, its potential use goes beyond ending early pregnancy. 

This is due to multiple biological effects. This explains why it works in an irrelevant state, such as a veteran with a brain injury or a pregnant woman seeking an abortion. In addition to blocking progesterone, thehormone cortisol 

cortisol is sometimes called a stress hormone because it is released in response to stress. However, cortisol also plays an important role in regulating blood pressure, blood sugar, metabolism, inflammation and sleep cycles. In short, too much cortisol can cause many illnesses. Having a safe and effective way to block the receptors that cortisol needs to act on these systems is of value to physicians treating all types of conditions.

At a dose slightly higher than the approved dose for abortion, mifepristone is also FDA approved for the treatment of Cushing's syndrome, a rare disease characterized by excess cortisol.

"This is a very good drug and a very powerful drug," Miami has been using mifepristone to treat patients with Cushing's syndrome since it was first approved. Dr. Atil Kargi, an endocrinologist at the university, said. "And there is no long-term toxicity we are aware of." 

"This chemical ... yes, it causes abortion, but it does many other amazing things. "Masu," said Leslie Edwin, patient and chairman of the Cushing's Syndrome Support Research Foundation. Edwin said he has been dependent on mifepristone for 18 months to manage the effects of excess cortisol in the body, such as severe weight gain and type 2 diabetes. "I had the option of a cortisol controller and I was grateful that it worked for me," she said.

"This is the only drug on the market," Klimas said. "If you remove this, you're removing a great big tool." 

"This is the only medicine on the market," Klimus said. "If you remove this, you're removing a big tool." 

"This is the only drug on the market," Klimas said. "If you remove this, you're removing a great big tool.

Pharmaceutical companies, including Corcept Therapeutics, which sells Mifepristone for Cushing's Syndrome under the name Korlym, block cortisol but progesterone. Is working on new drugs that do not block, but there is still a long way to go before they become available.

Apart from the two FDA-approved uses, mifepristone is a breast cancer, It has also been investigated in clinical trials such as brain cancer, progesterone cancer, alcohol dependence, post-traumatic stress disorder, and depression. 

Rita, Dean of the Department of Breast Oncology at Chicago University Dr. Nanda is conducting several breast cancer clinical trials investigating the effects of mifepristone and chemotherapy. In previous studies, chemistry was given to patients with activated sugar cortisol receptors in breast cancer tumors. It has been shown that the therapy does not work well, Nanda said.

"By blocking the sugar cortisol receptor with mifepristone, we can increase the effectiveness of chemotherapy. I want it, "she said. She is also in the early stages of trying to determine if this strategy is effective for ovarian and prostate cancer.

Klimus said he chose to try mifepristone in the Gulf War illness test. Mifepristone was the safest approved drug to do what she wanted to block the receptors that stress hormones bind to. She said she was trying to reset the stress signals in the brains of veterans with these illnesses by temporarily blocking these receptors. 

"We are trying to reuse the drug so that it can be delivered quickly to these people," she said. 

What does Roe's reversal mean in the study? There is none. Gulf War illness trials are limited to men between the ages of 45 and 70. "I don't think I've heard patients do more than laugh about it," she said. "Pregnancy is not one of the concerns of male veterans." 

Medical officers run from medical transport helicopter
1991 On February 8, 2014, a medical officer is fleeing from a medical transport helicopter in the desert of Saudi Arabia. A desert storm operation.AP file

Even before Roe overthrows, the turmoil in US abortion policy is more complicated for studies like Klimas's study. I was drawing a picture.

"I can't believe the logistic nightmare I faced in this study," she said. 

Originally, Klimus designed an outpatient clinic exam related to a university hospital. However, she had a hard time finding a research pharmacy to work with. This is a challenge due to changes in the policies surrounding Mifepristone. 

"I called all the pharmacies in the two counties, but couldn't find a pharmacy that could use mifepristone outside the hospital," she said. .. Eventually, she transferred her work to Miami VA. Miami VA has a research pharmacy in an inpatient hospital. The bureaucratic formalism involved in the move of the trial delayed the start by a year, after already being delayed by a year due to the blockade of the pandemic. 

Despite the fact that the makers of Mifepristone say that abortion restrictions should not affect studies of other conditions, Klimus faces these logistic challenges. I faced it. She said that both Danco Laboratories and Corcept Therapeutics, which sell Mifepristone for abortion under the name Mifeprex, will prioritize test-specific protocols that the FDA must clear. 

In theory, the study protocol could differ from the rules surrounding approved medicines, said Abigail Long, director of marketing and public relations at Danco Laboratories. 

In other words, clinical trials investigating mifepristone for purposes other than abortion are not subject to FDA restrictions on drugs when used for abortion. Until recently, during the pandemic, the FDA stopped enforcing face-to-face dispensing rules, including the rule that patients seeking abortion receive mifepristone directly from specially qualified prescribingpatients. Allowed oral contraceptives to be mailedThen, in December 2021, the FDA announced that it would permanently allow mailing options.Doctors need special certification to prescribe mifepristone, just as pharmacies dispense mifepristone. 

Many individualstates have created their own set of laws that limit the way patients obtain mifepristone for abortion, but, Legal issues are imminent as to whether these illegally violate the FDA's federal approval.

In astatementshortly after Friday's Supreme Court ruling, Attorney General Merrick Garland was based on a disagreement with the FDA's decision on the safety and effectiveness of mifepristone. The state said it could not ban mifepristone. 

"The Justice Department strongly opposes the court's decision," Garland said, calling the impact of this ruling on the lives of people across the country "immediate and irreversible." ..

This sets the stage for fierce court battles in states like Kentucky and Louisiana. It enacted a total ban on abortion, including abortion.The moment the court ruled 

These laws are legal, according to Patricia Zettler, a law professor at Ohio State University who focuses on food and drug regulation. Challenges can be exacerbated by new abortion restrictions in many states. 

"There will be many battles over what the state can and cannot do," she said. "The impact seen in the field of clinical trials depends on how narrow or wide states try to limit access to mifepristone." Legal restrictions on mifepristone for abortion have other uses. Even if it doesn't apply to clinical trials, Roe's reversal can complicate the study, she said.

"Beyond the actual legal environment, the impact on clinical trials is how medical professionals and institutions interpret state activities, and doctors and pharmacists are comfortable with prescribing and dispensing. It depends on what you can do. It is legally acceptable, "says Zettler.

Impact on multilateral trials 

A study of Gulf War disease in Klimus found only dozens of patients in the Department of Veterans Affairs, Florida. This is a small phase 1 study for patients. Florida. However, if the drug works, the study needs to be expanded to Phase 2 and Phase 3 trials, and more patients need to be enrolled across multiple state sites. 

Differences in abortion policies between states can be even more serious than they are today In Postlow America, researchers may have a hard time managing multistate trials. there is.

"This single-site survey in one state with one set of laws is bad enough," Klimas said. "But if we have to understand all the laws of every state we use as a site, it can be more complicated." 

Santa Clara University Law Professor Michel Overman focuses on the impact of the criminalization of abortion, and the burden of navigating the abortion landscape across state boundaries is one of the ways in which the reversal of law can have an impact. I think it is one. Mifepristone test.

"The Academy of Sciences will also move to the Red / Blue States," she hypothetically asked. "If you want to be a serious researcher, are you going to work in California or New York to develop new treatments?" 

Researchers who can choose the location of the trial are restricted to abortion She predicted that she was likely to stick to as few states as possible. And in that scenario, patients with more restricted conditions, especially those who cannot afford to travel, may miss clinical trials. For years, travel expenses have excluded people left out of society from clinical research, further complicating the outlook.

In paper, Oberman believes that clinical trials of mifepristone for non-abortion use will continue to be legal and viable. But in states where abortion is ready to become a post-low crime, she believes that the downstream effects of abortion are not limited to those that are technically legal. 

"No prosecution is needed to change the way people feel about these medicines, or the way people prescribing or investigating these medicines think about their research," she said. rice field. "The urge to not get involved in the law is beginning to appear. If you are a doctor who really hates risk and is incredibly driven to help patients, you practice medicine elsewhere. You may find it necessary, because the risk is never zero. "

With Roe's overthrow, Klimas moves the Gulf War illness trial to VA Hospital. Ironically, I wondered if what I did would work in her favor. "This is Florida," she said. "If it's possible to do something to limit abortion, that's what happens here. But I hope the Veterans Affairs move can save me. The Veterans Affairs Department is a federal government. In his statement about the agency and the decision, Garland emphasized the Department of Justice's position that federal agencies and their employees respond to federal law rather than state law. She said she was seeking legal advice on what the Fepriston Act meant for the Department of Veterans Affairs Hospital. 

Meanwhile, she had thousands of decisions in the Supreme Court. I'm worried about what it means for an already disadvantaged woman, and for the fate of her veterans at the Mife Priston trial. 

"Because you served the country. Isn't it sad to finally find a cure for your illness? It sucked 30 years of your life-and it was stopped because of an abortion quarrel. "