My article in today’s HeadlineBistro.
The first part of this series showed how the Food and Drug Administration’s (FDA) newest contraceptive drug, Ella (Ulipristal acetate), is in reality an abortifacient like RU-486. It argued that FDA’s marketing of Ella as strictly a contraceptive that denies its abortifacient capabilities, which are abundantly evident to most informed non-scientists, is the culmination of a series of lies through omission. Here in Part II, we will see all the safety data that the FDA deliberately ignored, and all of the safety investigations it didn’t bother to make the manufacturer perform.
In a June 2, 2010, letter to the FDA’s Advisory Committee for Reproductive Health Drugs, Dr. Donna Harrison, president of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) outlined the deficiencies in the safety data and proposed labeling of Ella. This article summarizes those deficiencies and the reader is referred to the letter for the details.
The first great omission was that of transparency in the drug approval process. According to FDA Commissioner Dr. Margaret A. Hamburger, who wrote in a letter to her colleagues:
“FDA is advised by 49 committees and panels with more than 600 members. These committees provide advice on specific regulatory decisions, such as product approvals, and general policy matters, such as regulations and guidance. … [t]he primary goal of the advisory committee process is to bring high-quality input to FDA in order to support agency decisions.”
In reality, FDA required comment submissions from advisory groups such as AAPLOG by a deadline without any prior releasing of the data on the drug. Harrison and AAPLOG were forced to use the publicly available data from the European Medicines Agency, as Ella is already available in Europe, sold under the brand name EllaOne.
According to the European agency, “EllaOne is contra-indicated during an existing or suspected pregnancy.” Right there is the admission that this drug can serve as an abortifacient. But there are additional issues beyond the immediate embryocidal effects that are associated with this contraindication.
It is important to note that 2 percent of all pregnancies subjected to Ella will survive the treatment. That means 20,000 babies for every 1 million treatments, and no studies were performed on the toxicity of Ella on the surviving fetuses.
The European agency admits that there are very insufficient data regarding the developmental effects of Ella on surviving fetuses. It is beyond comprehension that no reproductive toxicity studies have been performed on Ella when International Conference on Harmonisation guidelines clearly requires such studies to be done. The European agency states:
“Reproduction toxicity data are insufficient due to lack of human and animal pharmacokinetic data. Due to its mechanism of action, [Ella] has an embryolethal effect in rats, rabbits (at repeated doses above 1 mg/kg) and in monkeys. The safety for a human embryo is unknown.”
The purpose of animal studies is to extrapolate to humans what is found in evolutionarily similar animals such as monkeys. Combining the mechanism of action described in Part I and the lethal effect for embryos in all tested animals, it isn’t difficult to make the connection that Ella has an embryolethal effect on humans.
Additionally, studies in monkeys indicate the presence of Ella in reproductive and other tissues 14 days after single dose administration, a presence that far exceeds the touted five-day window of drug effect. Many women will certainly use this drug more than once per menstrual cycle, so the lasting effects remain unresearched and unknown.
According to Harrison, the European agency based their safety assessment of Ella on a single 30 mg dose per menstrual cycle and based on that alone they “lowered or waived required safety, toxicology and pharmakodynamic study requirements for:
1. Human in vivo metabolism data
2. Single dose toxicology studies
3. Dose recovery studies
4. Carcinogenicity studies
5. Toxicokinetic documentation
6. Bioavailability and absorption studies
7. Mechanism of action with regard to threshold concentration effects
8. Formal dose proportionality studies
9. Information on drug interactions in patients with renal or hepatic impairment
10. Pharmacokinetic interaction studies.”
Were that all not enough, the European agency also identified other unstudied populations, such as women over the age of 35, women who are on concomitant hormonal contraceptives (use for “missed pill” contraceptive failure), lactating women, and adolescent females, for whom no safety or efficacy studies have been done.
It is accepted in the pro-life community that abortion, and its proponents, are among the most corrosive influences on the public health. The machinations behind the passage of Ella constitute a case study in how, yet again, women’s health is sacrificed at the altar of this modern-day Moloch. No serious scientist or physician can look at this appalling list of omissions in safety and toxicity studies, the lack of transparency surrounding the hearings, and conclude that the FDA had women’s health at heart. There are well-established, rigorous scientific and regulatory protocols for the approval of new drugs, a frightening number of which were either incomplete, or not engaged at all in the case of Ella.
This is primarily about population control, a driving ideology behind the Culture of Death. It is not only cultural, but civilizational suicide. The surest way to defeat this is at the grassroots level, by spreading the word among women of just how dangerous abortion is for them, and the conspiracy of silence among those scientists and physicians who have betrayed every ethical precept in railroading an unsuspecting public.
In addition to getting out the truth, our prayers and our support of crisis pregnancy centers are two of our greatest weapons in reestablishing a Culture of Life and a Civilization of Love.