Tuesday, June 18, 2024

Doctor suing FDA recruited to scientific advisory board to ‘repurpose’ abortion pill

It’s anti-abortion activist George Delgado’s latest foray into consulting outside his medical specialties.

One of the anti-abortion doctors suing the U.S. Food and Drug Administration to rescind its 2000 approval of a medication abortion regimen on the basis that one of the drugs is dangerous is now consulting on the development of a breast cancer treatment that involves the same drug: mifepristone. It is the family doctor’s latest foray into medical consulting outside his medical certifications.

Dr. George Delgado is joining the scientific advisory board of Res Nova Biologics, Inc., which is developing a breast cancer treatment using mifepristone, despite plaintiffs’ arguments in the lawsuit that federal approval was illegally rushed (it was a four-year process) and that the drug’s approved use for first-trimester abortion should be reversed.

But in the press release announcing his role with Res Nova, he said: “In my opinion the concept of leveraging the effects of the abortion pill in life-saving as opposed to a life-taking scenario is extremely exciting. I am proud to join such a specialized team of therapeutic developers in advancing this novel approach to tumor immunotherapy.”

Delgado is among the four anti-abortion doctors and four conservative Christian medical groups whose claims are largely based on anecdotes and research that has raised red flags. And they contradict overwhelming evidence that mifepristone is safe after 5.6 million uses and effective for first-trimester abortions, miscarriage management and other medical conditions. The American Medical Association has accused the conservative courts that have advanced the case of  “elevat[ing] speculative pseudoscience over data and evidence, arbitrarily rolling back access to a safe and effective drug and leaving millions of women without a critical medication for reproductive health care.”

Nevertheless, the fate of U.S. abortion access once again rests on a forthcoming decision from the U.S. Supreme Court, to either take up this case, or effectively reinstate old restrictions to the drug. Conservative judges in lower courts have relied on plaintiffs’ claims along with testimony from Delgado and the other doctors alleging personal harm because mifepristone is FDA-approved for abortion.

In a legal declaration submitted in November 2022, Delgado wrote that he has treated women who “suffer complications from chemical abortions,” but he gave only examples of women whom he says felt regret and emotional distress. As an argument for standing, Delgado also said he loses money when patients have a medication abortion instead of seeking prenatal care services at his family practice in Escondido, California, which also offers anti-abortion counseling and a controversial protocol claiming to reverse the effects of mifepristone. The American College of Obstetrician Gynecologists says this protocol is “not supported by science.”

“[T]here is a tangible financial loss to my practice in losing the opportunity to render professional prenatal care for the mother or to care for babies who are never born,” he wrote.

Delgado is an outspoken anti-abortion activist best known for so-called “abortion pill reversal,” which is unregulated by the FDA and whose unverified claims led the AMA to sue North Dakota in 2019 over a state law promoting the procedure. Delgado serves on the American Association of Pro-Life Obstetricians and Gynecologists’ board of directors, despite not being an OB-GYN. At the height of the Covid-19 pandemic, Delgado also testified as a medical expert to keep mega churches open, though he is not a public health expert or epidemiologist. In legal filings he claimed expertise from having “treated many people with infectious diseases, including viral illnesses such as influenza, which tend to occur in epidemics.”

Now the family doctor has been recruited to the scientific advisory board of the biotech company based in Chula Vista, California, that is developing a breast cancer treatment using mifepristone.

Res Nova, a breast-cancer-focused spinoff of Therapeutic Solutions International, Inc., is developing FloraStilbene, a “proprietary formulation of RU-486 and pterostilbene which has been shown to overcome tumor associated immune suppression and increases responsiveness to chemotherapy and immunotherapy.” According to the press release (which refers to mifepristone as RU-486, the name the drug had during laboratory testing), the company “seeks to enter clinical trials of ‘repurposed’ abortion pill for breast cancer” and has signed with a compounding pharmacy.

“The similarities between pregnancy and oncology, including angiogenesis, immune modulation, and rapid growth are striking,” Delgado said.

Delgado is certified in family medicine and hospice and palliative medicine by the American Board of Family Medicine, and is not specialized in oncology or immunology. The Res Nova advisory board members currently listed on the website (Delgado has not yet been added) includes members with diverse specialties, including a board-certified neurologist and neuro-oncologist, a pharmacist, an attorney, a technology executive, and an IT consultant.

Res Nova president and CEO Famela Ramos—who is a nurse, an unsuccessful congressional and school board candidate, and on the board of an anti-abortion pregnancy center in Chula Vista—said she recruited Delgado partly because of the so-called abortion reversal technique he’s spent more than a decade developing and promoting.

“Having known the work of Dr. Delgado for many years and his great success in defending both the mother and the baby, it is exciting to have the opportunity to utilize his scientific and medical expertise in this unique intersection of reproductive medicine, immunology, and oncology,” Ramos said in the announcement, which refers to Delgado as an “expert in the biology of pregnancy and the abortion pill” and does not mention his lawsuit against mifepristone.

Delgado has also suggested that abortion is linked to breast cancer, a common anti-abortion claim. But according to the American Cancer Society, “scientific research studies have not found a cause-and-effect relationship between abortion and breast cancer.”

Ramos and Delgado declined to respond to States Newsroom’s questions.

Major U.S. medical groups have argued that Delagado’s lawsuit could have long-term consequences unrelated to pregnancy termination—and could upend drug research and development. Mifepristone is currently being investigated in clinic trials for a variety of cancers and mental health disorders. This lawsuit targets mifepristone for the specific use of abortion, and the drug’s manufacturers have said restrictions on the medication abortion regimen would not apply to clinical trials investigating mifepristone for non-abortion use. However, researchers have reported that even before Roe v. Wade was overturned anti-abortion policies made it difficult to study mifepristone.

Already mifepristone can be difficult to access for people who want abortions, but now the drug is also hard to access for the off-label use of miscarriage management because of high demand and confusion around medication abortion laws, according to States Newsroom affiliate Stateline.

“Dr. Delgado’s research interest in mifepristone as a potential preventive for cancer demonstrates the significant medical value that mifepristone provides,” said Molly Meegan, chief legal officer and general counsel for the American College of Obstetrician Gynecologists, which has filed friend-of-the-court briefs defending mifepristone’s approval and safety record in the FDA lawsuit.

Delgado helped create a network of anti-abortion health care providers willing to perform the so-called abortion pill reversal treatment without much data behind it and based on the doctor’s training at an institute that teaches a Catholic-friendly approach to reproductive health. The anti-abortion pregnancy center network Heartbeat International now manages the Abortion Pill Rescue Network.

The FDA’s medication abortion regimen, which is currently recommended for up to 10 weeks’ gestation, involves mifepristone to block the hormone progesterone, followed by the medication misoprostol which causes contractions. The “reversal” protocol has patients forgo the second drug in the regimen and receive doses of progesterone. States Newsroom has interviewed a patient who remained pregnant and gave birth to a healthy baby after going through this treatment at an anti-abortion pregnancy center in Idaho. But medical groups like ACOG and the AMA say there’s not enough evidence to show that it’s the progesterone that continues the pregnancy versus not completing the abortion regimen. The one attempt at a controlled study of this protocol ended prematurely because the OB-GYN and mifepristone expert leading the study determined it was unsafe after three patients hemorrhaged.

Though several states have passed laws requiring abortion clinics to tell patients they could potentially reverse their abortions if they change their minds, some states are now pushing back on the promotion and marketing of this treatment.

The California attorney general is suing Heartbeat International and another California-based crisis pregnancy network that have widely marketed “abortion pill reversal” despite its unproven claims, under the state’s False Advertising and Unfair Competition laws.

Earlier this year Colorado became the first state to ban the procedure, which was followed by a lawsuit from a Catholic clinic. State regulators have ruled that so-called “abortion reversal treatments” are not an accepted medical practice. But over the weekend, a federal judge appointed by former President Donald Trump blocked the new state law, citing the plaintiffs’ religious freedom.


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