I suppose I could use a female condom, but...

MGH Weight Center
50 Staniford Street
4th Floor
Boston MA 02114

To whom it may concern:

I was just reading over the consent form for the lorcaserin study, and I noticed something I wanted to bring to your attention:

In the section about acceptable forms of birth control, "condom plus spermicidal jelly or foam" is listed as an acceptable form of birth control. Later in the section, it says "abstinence (no sexual intercourse), and a partner who cannot get pregnant/father a child are not acceptable methods of birth control for this study."

I am female and am in a monogamous married relationship with a female. If I were to take part in this study, what method of birth control could I use? My partner is not able to get me pregnant or become pregnant by me, but as this is not an acceptable method of birth control, I would need to use one of the acceptable methods, such as "condom plus spermicidal jelly or foam." I guess I would need to know when exactly I would use said condom plus spermicidal jelly or foam. I also ask the same question of an abstinent person. A friend of mine, who is a monk, does not engage in sexual activity. Since this is also not acceptable, she would need to use aforementioned condom plus spermicidal jelly or foam. When would she need to use this in order to meet your requirements?

I recognize that my examples are a bit ridiculous, but I think this points to a logical flaw in your requirements. I understand that these requirements may have been written based on the knowledge that penile/vaginal intercourse often occurs without having been anticipated and/or wanted. However, the fact that condom use is listed as an acceptable method of birth control does not address this, as condoms, unlike hormonal methods of birth control, require planning in terms of their availability and require consent on the part of both partners.

If condom use is acceptable (which I presume refers to its use during penile/vaginal intercourse), why would absintence or sexual relations that cannot result in pregnancy not be acceptable? Based on your logic, my form of birth control would only be acceptable if I additionally agreed to always use a condom and spermicidal jelly or foam during my female/female relations.

Thank you,


Jodie said...

Hasn't there also been some recent study that spermacial foams/jelly actually make you more susceptible to HIV? That's a pretty crappy requirement. I could see if they were going to require all females to be on hormonal birth control just because there are some things in life we don't have control over, but uh, yeah, if condoms are acceptable...

And sometimes people are just dumb.

eeka said...

The study was only nonoxynyl-9, so I think we don't know about whether other spermicides make HIV transmission rates greater than without. But yeah, it's the most common one, and it seriously raises transmission rates of HIV.

There've been some studies that required hormonal birth control for all female participants, and many physicians question the ethics of this, since it assumes that the female isn't capable of choosing to understand the risks of a severely deformed baby and choose to abort or make her own damn decision to bear and raise a severely deformed child. It's along the same lines of the physicians who required hormonal birth control for women before they'd prescribe Accutane. The various conferences held on this state that it's strongly recommended as part of the informed consent, but it's of course ultimately one's own decision to risk having a severely deformed kid. Oh, especially in this study, it's unknown whether a male would be presented with reproductive risks. So should males be chained up somewhere and only allowed supervised conjugal visits with females whose blood levels show that they're taking the pill? It's just not realistic to police this sort of thing, and provided that they're clearly explaining the risks, the study doctors aren't going to be liable for someone's deformed baby.

Oh, the MGH person wrote back and said I'd certainly qualify, and they can revise the language on the consent. HEE.

(I didn't mention in my e-mail that I'm not fat enough to participate anymore anyway.)

Anonymous said...

This is so ridiculous. Good for you for writing them.

-Abstinence is not an acceptable form of birth control; you must use a condom.
-Okay then, I'll use a condom every time I have sex, which is never.

-Abstinence is not a sufficient birth control method; you must use a condom.
-Abstinence is insufficient? So when I am walking around all day in between periods of sexual intercourse, I have to be using a condom?

-You must use a condom; abstinence is not allowed.
-Not allowed? I'd better get busy having sex then.

-No, you must use a condom; we don't believe you that you aren't sexually active.
-But you trust me to make proper use of a condom?

And, regarding your subsequent update:

Clearly you would be eligible in regards to the birth control criteria. The intent is to try to prevent anyone in the study from becoming pregnant.

So what is it that makes your situation "clearly" acceptable? (It should be, but so should others.)

-I'm in a monogamous relationship with a partner of the same sex.
-Okay, *for you* we'll re-word the consent and trust that you aren't having sex with anyone of the opposite sex, but we aren't going to trust anyone who claims not to be having any sex at all or anyone who claims to be having sex only with an opposite-sex sterile partner; they're obviously liars and you're obviously not.

[Note: I'm not suggesting in the last example that Eeka is a liar, only illustrating that someone can just as easily lie or be truthful in either situation.]

It's amazing how many medical professionals will assume people are sexually active even when the people tell them that they are not.

-I'm not sexually active.
-So do you use condoms?

-When was your last period?
-I don't remember.
-How can you not remember? Don't you keep track?
-I think it was at the beginning of last month.
-It's late! You could be pregnant!
-No, my cycles are long and irregular, and I'm not sexually active.
-Okay, I'll schedule a pregnancy test.

When the last period was is a stupid question when what they really want to determine is whether there is a chance of pregnancy.

If the participants aren't trusted to not get pregnant even when abstaining from sex, shouldn't there also be something about not trying to get pregnant or impregnate through alternative means? Wouldn't the partners have to sign consent forms too?

Also, it occurs to me, if they are saying abstinence isn't sufficient because of people claiming to be abstaining while using the rhythm method, then they should make a clear distinction between actual abstinence, which obviously wouldn't call for condom use, and abstaining *at certain times* as part of the fertility awareness practice, which would call for additional measures.

And if they are saying abstinence isn't sufficient because they fear someone who is not sexually active upon joining the study becoming sexually active sometime during the study, then they should accept that the person is currently not sexually active but make sure the person has condoms available and knows how to use them should the situation change.

I don't know, maybe they have some experience with people who stated that they would abstain for the duration of a previous study, and then didn't. It wouldn't be a good plan for someone who is, for instance, married. Abstinence is still an acceptable method of birth control, but in such cases it is not a smart birth control *plan* and needs backup. They need to recognize, however, that there is a difference between people who are generally sexually active attempting to refrain from an available opportunity and people who are not sexually active continuing to live life as is usual for them.

While I think the mention of the situation with Accutane is apt, what with the not trusting women and wanting to take too much control after sufficient information and instruction has been given, and the different treatment for females than for males, there is a difference. With the prescription of Accutane, the patient provides payment for medical consults and prescription costs; with a study, the participant is being provided with same at no cost, but if the participant gets pregnant and needs to be dropped, the study has lost time, money, and data.

That the response to your letter spoke of wanting "to prevent anyone in the study from becoming pregnant" could be evidence that they are much more concerned with female participants becoming pregnant and having to be dropped than with male participants impregnating others.

Oy, I still can't get away from the no sexual intercourse not being an acceptable method of birth control.

-Abstinence is not acceptable; you must use a condom.
-When do I use the condom if I'm not having sex?
-Every time you have sex.
-But I don't have sex.
-That's not acceptable! You must use a condom!
-Every time you have sex.
-You don't seem to understand; I am not sexually active.
-You still need to use a condom.
-Okay, a condom is to be used with sexual activity, yes?
-Abstinence, unlike a condom, is not a birth-control product to be used in conjunction with sexual activity; abstinence is the act of refraining from sexual activity and means that there is no sexual intercourse.
-No sexual intercourse? That's not acceptable! You must use a condom!
-Who's on first?

eeka said...

Anonymous, you rock. And you're smart. And logical. And I have a few hunches who you are. But it's more fun leaving it blowing in the wind a little. :o)

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