Linepharma, Mifegymiso, adverse reactions, and profit

This is my final post in this five part series on Linepharma, who markets, distributes, sells and profits from abortion in over 25 countries, including Canada. 

I've only documented a few of the adverse reaction cases from the 195 page ATIP package I received. You can view the other cases here from my Health Canada ATIP.

https://run-with-life.blogspot.com/2022/01/improving-womens-health-one-abortion-at.html

https://run-with-life.blogspot.com/2022/01/mifegymiso-case-17-year-old-serious-and.html

https://run-with-life.blogspot.com/2022/01/mifegymiso-case-37-year-old-life.html

https://run-with-life.blogspot.com/2022/01/mifegymiso-case-36-year-old.html

I cross referenced the 195 page report to the Canada Vigilance Summary of Reported Adverse  (43 records for MIFEGYMISO). Notice this from the first page of the summary report

"CAVEAT (from the report): This summary is based on information from adverse reaction reports submitted by health professionals and laypersons either directly to Health Canada or via market authorization holders. Each report represents the suspicion, opinion or observation of the individual reporter. The Canada Vigilance Program is a spontaneous reporting system that is suitable to detect signals of potential health product safety issues during the post-market period. The data has been collected primarily by a spontaneous surveillance system in which adverse reactions to health products are reported on a voluntary basis. Under reporting of adverse reactions is seen with both voluntary and mandatory spontaneous surveillance systems. Accumulated case reports should not be used as a basis for determining the incidence of a reaction or estimating risk for a particular product as neither the total number of reactions occurring, nor the number of patients exposed to the health product is known. Because of the multiple factors that influence reporting, quantitative comparisons of health product safety cannot be made from the data. Some of these factors include the length of time a drug is marketed, the market share, size and sophistication of the sales force, publicity about an adverse reaction and regulatory actions. In some cases, the reported clinical data is incomplete and there is not certainty that these health products caused the reported reactions. A given reaction may be due to an underlying disease process or to another coincidental factor. This information is provided with the understanding that the data will be appropriately referenced and used in conjunction with this caveat statement."

Lots of wiggle room there. Notice this statement: 

"Under reporting of adverse reactions is seen with both voluntary and mandatory spontaneous surveillance systems." (emphasis added)

Presumably there are many adverse reactions that are never reported to Health Canada. How many? We will probably never know. But women who take this deadly pill are really on their own. They go home, take the pills, and who knows what consequences these women will suffer? And will they be reported?

Medical abortions really just add another whole level of evil to the already abhorrent reality of abortion.

Mifegymiso case 36 year old, hospitilization, sepsis, missing information

This report for a 36 year old woman who suffered from sepsis after a Mifegymiso abortion, bears a strong similarity to some of the other reports.

It contains a lot of unknown information about her case.

A 36-year old female patient, unspecified weight and height, with unknown medical history, was administered Mifegymiso...unspecified dosage for induced abortion. Time frame was unknown. Time of gestation was not provided.

Concomitant treatment was not reported.

Corrective treatment, if any, was not reported.

The patient recovered from the event on unspecified date.

The health authority evaluated the case as serious (Hospitalization), coded sepsis as adverse reaction, suspected Mifegymiso and did not assess the causal relationship between Mifegymiso and the adverse reaction. (but I think we know the answer to this one)

Seriousness: -sepsis: yes (hospitalization) 

Causality assessment: Very poorly documented case, time frames and dosage of mifepristone administration were not provided. Chronology was unassessable.

Missing information: Confirmation of misoprostol administration.

More than one of these reports contain this lack of information. Why is that? Why isn't Health Canada following up with the person who reports the adverse reaction, to obtain this information? Isn't that a kind of crucial aspect of this reporting system?

Mifegymiso case 37 year old, life threatening and involved or prolonged inpatient hospitalization

In 2017 a 37 year old woman suffered "life threatening and involved or prolonged inpatient hospitalization".

From her Adverse Reaction Report:

"Report received [date]. 37 year old woman with unknown medical history. Received Mifegymiso. Patient was 45 days gestation.

Patient presented for follow-up appointment with heavy bleeding and vasovagal (See below). Ultrasound scan detected retained product of conception in and around cervix that physician attempted to remove. An assessment of stat hemoglobin was ordered, then patient called at home to [be] given results at 130. A date for dilation and curettage was booked by clinic. Patient reported passed large clot size of an orange on way home and felt much better. 

On [date], nurse called in the morning and patient said bleeding was only spotting and she felt better and cancelled dilation and curettage.

On [date], patient reported being admitted to hospital with hemorrhage and loss of consciousness on date with low hemoglobin and iron. She underwent emergency dilation and curettage and blood transfusion."

Reactions:

"Loss of consciousness, Low hemoglobin, Low iron, Hemorrhage, Transfusion, D&C, Syncope vasovagal, Retained product of conception, Heavy bleeding"

Notice the use of Retained product of conception. A human being by any other name.

"Vasovagal syncope (vay-zoh-VAY-gul SING-kuh-pee) occurs when you faint because your body overreacts to certain triggers, such as the sight of blood or extreme emotional distress. It may also be called neurocardiogenic syncope.

The vasovagal syncope trigger causes your heart rate and blood pressure to drop suddenly. That leads to reduced blood flow to your brain, causing you to briefly lose consciousness."

Mifegymiso case 17 year old, serious and life threatening

"Linepharma is a pharmaceutical company committed to improving sexual and reproductive health through expanding access to safe medication abortion."

Further to my last post about the company whose only product kills babies, I did an ATIP to Health Canada on the abortion drug Mifegymiso. My request:

"I would like to obtain the total number of medical abortions (mifepristone and misoprostol) dispensed in Canada since the drug became legal in 2017. I would also like to see any reports of adverse affects  attributed to these medical abortions in Canada since the drug became legal in 2017."

I am still waiting for the first part of my request, and received info back on the second part about adverse effects.

The first woman I will discuss who suffered from this dangerous drug was 17 years old. There are records for her from 2017, 2018, 2019 and 2020 in the system. I have no idea how long she suffered from her abortion, but there was a lot of paper work done on her.

Her case was classified as serious, life threatening.

This woman suffered the following horrible reactions to this drug.

Loss of consciousness, Hemoglobin low, Iron low, Hemorrage,Transfusion, Dilation and curettage, Retained products of conception, Heavy bleeding, Large clot, Toxic shock syndrome, Off label use, Escherichia sepsis (E. coli), Septic abortion, Abortion infected, Cardiovascular collapse, Circulatory collapse, Percutaneous cardiopulmonary support, Lung assist device therapy

Case Narrative: "Septic shock secondary to septic aabortion from incomplete medical abortion - was provided mifegymiso at 11-2 GA (well out of recommended gestational age); E.coli identified in blood cultures and from uterine contents; patient presented in cardiovascular collapse to local hospital, was transferred to other hospital level 2 center, urgent D&C carried out and ICU admission required with respiratory/cardiovascular support required, developed septic cardiomyopathy; recovered with extensive antibiotic coverage and intensive care; ultimately was discharged home with close followup."

This case was flagged as off-label use because:

"She had unknown relevant medical history. 11 Weeks 2 days gestation (79 days) patient received Mifegymiso beyond 63 days gestation." (emphasis added)

Interesting that 63 days number. Because from this Canadian Medical Abortion Dispensing Guide it says up to 70 days. So what is it Linepharma, 63 days or 70 days? And how do you make sure that women don't take it past this time like this girl did?

On one of the reports was the following comment.

"The case was reported by a physician to Health Canada on 22-Mar-2018 and retrieved by Linepharma on 16-Dec-2019."

Linepharma took a 21 full months to retrieve the information about this poor girl. You'd think that they would be a tad more interested in knowing about this horror story. And the other horror stories of women taking this dangerous drug. That they produce, market, make money from, and send around the world. 

How many people in countries not as advanced as Canada suffer from similar reactions? And what will happen if we start sending Mifegymiso to Africa? God only knows.