Phexxi marketing material is misleading - Half as effective as advertised!

[ahcadvocacy]

@katrina2017 Ah, it's interesting to hear how other places do it! I'm in Canada, but lived in the States for awhile. It's... bonkers.

 

[katrina2017]

@ahcadvocacy I think Canada is a closer experience health and welfare wise to New Zealand as you are a commonwealth country. Kiwis have more in common with Canadians in general!

 

[nancya2]

@ahcadvocacy I became pregnant off Phexxi after using it twice and as directed. My abortion is this week.

I already made a post about this, but it became locked due to people (investor bros) harassing me. So, if you need to remove my comment, feel free to do so. I'm posting in the hopes that this will reach more people.

I'm trying to tell everyone and anyone who will listen. I would not have taken the same risks had I known I was being lied to.

 

[pamelaquezada]

@ahcadvocacy @OP You obviously seem upset by this. This product was approved by the FDA. If you suspect you know something that the FDA doesn’t, please speak up you damn genius @rebekahlynn

 

[ahcadvocacy]

@pamelaquezada Spermicide is also FDA approved. I am not saying it is not ineffective, I am saying it is less effective that it claims to be on all the marketing materials. I am saying that is anti-consumer.

You're correct, I am upset. People cannot make good decisions on bad information, and the idea of people going through unintended pregnancies because of bad information is upsetting. That is a normal human reaction to this.

 

[southerngirls]

@ahcadvocacy Honestly, I think this is not as big a deal as it sounds. We know from page 6 of the Phexxi Fact Sheet[1] that 101 women out of the 1183 in the study (median age = 27.8) became pregnant. That is, 1082 women (or 92%) had sex 3 times a month for 7-months while using Phexxi and avoided pregnancy [2]. That sounds like a pretty strong result to me.

Yet OP is claiming the actual failure rate is 27.5%, because the trial didn’t last for a full year. According to that reasoning, if the study had lasted another 5 months, an additional 225 women would have become pregnant. But that is more than double the number of pregnancies that were actually observed! It does not make sense, especially given the smaller pool of women (women leave the study after becoming pregnant) and shorter time frame (5-months vs 7-months).

In other words, what OP is claiming is that after 7 months of avoiding pregnancy with Phexxi (0% failure rate), in the next 5 months the failure rate for these women would jump to 21% (225/1082).

Even more simply, it is like saying: "We know that 101 women got pregnant in the first 7-months, we think another 225 would have gotten pregnant in the next 5".

This is highly speculative, to say the least, and in my view, not very realistic at all.

Also, there is nothing special about the Pearl Index. It is not “the” failure rate, it is a “a" hypothetical failure rate based on a number of questionable assumptions, which is why it has its fair share of criticisms [3], for example: "[The Pearl Index] does not serve as an estimator of any quantity of interest, and comparisons between groups may be impossible to interpret.”

[1] Phexxi Fact Sheet: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208352s000lbl.pdf

[2] This is overstating it somewhat. Not all women had sex every month.

[3] Pearl Index: https://en.wikipedia.org/wiki/Pearl_Index#Criticisms

 

[ahcadvocacy]

@southerngirls Hi throwaway.

I am not speculating on these numbers. These are the numbers Phexxi published in their literature.

[2] This is overstating it somewhat. Not all women had sex every month.

Cycles that did not have sex or were too long or too short were not included in the statistical analysis. That's why there were 4769 cycles, not 8281 cycles being included in the analysis. That's more like 4 complete months of data, not 7. That is why them, not me, would predict failure rate would approximately double.

If you're saying the numbers are bad and misleading, it's Phexxi's study design and statistical analysis. Not me.

 

[southerngirls]

@ahcadvocacy This is not a throwaway, I am just a new user.

In any case, I probably could have worded it better. I didn't mean to imply you were speculating. You quoted the number accurately. What I meant was that the calculation is inherently speculative.

I think its important to note that Evofem (the makers of Phexxi) is not "predicting" a 27.5% failure rate. They are simply reporting the output of a flawed calculation (flawed regardless of study design), possibly due to FDA requirements.

Thanks for starting the discussion! I agree that it would definitely be helpful to have more info on the study, for example a fuller breakdown of why cycles were excluded (i.e. we don't know how many were due to pregnant women leaving, to cycle length, or to lack of sex)

 

[ahcadvocacy]

@southerngirls It's very hard to talk to you investors without insulting your lack of understanding around science, so I'm going to stop now.

The marketing is misleading and overstates the effectiveness. I have no issues with the science or the FDA

 

[southerngirls]

@ahcadvocacy I’m just stating the facts. If I’ve misstated something feel free to let me know. That would be more productive than making assumptions about me and insulting me. I believe that you are misleading people telling them the failure rate is 27.5% when we do not know that. As I’ve said, the Pearl Index is just guesswork yet you are treating it as if it were infallible.

Also, I never said you had any issues with science or the FDA so I don’t know what that statement has to do with anything.

 

[katrina2017]

@southerngirls Turned out to be a throwaway acct