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    Saturday, March 08, 2003

    Contraceptive Concerns: Glenn Reynolds posted an email from an ob/gyn who's writing a book about contraception and who labors under the impression that we're contraceptively deprived here in the US:

    1) the U.S. is one of the few countries in the world where women don't have access to hormonal implants or combination injections.

    Depo-Provera, although it isn’t a “combination injection,” but only one hormone, is an injectable progesterone contraceptive that is very popular here. And we have Lunelle, a combination of progesterone and estrogen. It isn’t as popular, however, because it has to be injected once a month. (Depo-Provera only has to be injected every three months.) We once had Norplant, an implantable hormonal contraceptive, but it was taken off the market because of weak sales, and because of lawsuits. Women were disappointed in its rate of side effects and the difficulty involved in removing the implants.

    2) the only hormonal Intrauterine device (IUD) available in the U.S. is Mirena, an older type of IUD (more prone to causing side effects.)

    Also not true. We have Progestasert (a progesterone IUD), which is still available ( see here and here) as well as the newer Mirena, which relies on the hormone levonorgestrel, a synthetic progesterone. Both have to be replaced once a year, which limits their popularity. Then we also have the non-hormonal, copper-based ParaGard.

    Lawsuits from the old Dalkon shield IUD have a lot to do with the limited investment in IUD’s in this country, as does the free market. Like the implantables and injectables, these just aren’t as popular as the pill.

    3) although a step in the right direction, the Today sponge is the only brand which contains the highest amount of the spermicide Nonoxynol 9 (N-9). N-9 has been clearly linked to an increased risk of HIV transmission (relevant articles)

    The sponge is also associated with higher rates of pregnancy and other sexually transmitted diseases. It isn’t such a great choice given the other options we have out there. And although it might have been popular with Elaine, it wasn’t all that popular with the majority of women. (Who wants to risk STD’s and pregnancy?) It, too, was taken from the market for business reasons rather than health reasons. The manufacturer didn’t want to shell out the money to upgrade its production plant. Now, if the sales of the sponge had been profitable enough to justify the upgrade, things probably would have been different.

    The truth is that here in the US, our “personal choice” drugs, such as contraceptives are subject to free market forces (with some litigation forces thrown in) rather than government largesse. And the other truth is, that there isn’t all that much room for improvement in birth control. The pill is highly effective, well-tolerated, and easy to take. Hard to beat that. Although a male birth control pill would be a fine innovation.

    UPDATE: Dr. Wendy Kroi, Instapundit’s correspondent on the issue of contraception in America, sent the following reply to my post below:

    Depo-Provera is a progestin-only injection. I was referring to the estrogen-progestin group of injections--no method in this group is currently available in the U.S. Lunelle was introduced in the U.S. in 2000. Regrettably, in October 2002 it was withdrawn from the U.S. market and it is not currently available.

    I thought my post made the distinction between Depo-Provera and Lunelle pretty clear. But, her original statement did not make clear that not all injectable contraceptives are combined hormone products. I thought it important to point out that injectable contraceptives are available here. As for Lunelle, it was the single dose vials that were removed from the market, after concerns about their effectiveness. Multi-dose vials were not recalled. (Although, I'll grant that mutli-dose vials aren't often used.)

    Regarding hormonal implants, the fact that Norplant, an older version, was taken off the market because of lawsuits or side effects, is no excuse to deprive American women of the newer and much improved version of implants like Norplant II (Jadelle) or Implanon. Again, an entire group of contraceptives is not available in the U.S.

    To say that American women are being “deprived” of alternative contraceptives is to suggest that there is some organized effort to keep these products off the market. That isn’t the case. Instead, it’s a complex interaction of business decisions and social concerns. If there were fewer lawsuits and more demand, then companies might be more interested in offering them here. As it stands, they don’t feel they are worth the riskst. And, as free members of society and the only consumers of those products (therefore the ones who are litigating and who influence the demand), American women bear some responsibility for the state of affairs. It is true that we have a fairly stringent drug approval process compared to a lot of other countries, but that isn’t necessarily a bad thing. Especially when you’re talking about drugs for which there are safe, available alternatives.

    Progestasert is the oldest type of hormonal IUD. It was introduced in 1976 and since 2001 it is no longer manufactured*. Mirena has been available in Europe for over 10 years. The fact that it was made available to American women only recently (in December 2000) does not make it a "new" IUD. The truly new hormonal IUDs are the T-LNG14 (the "updated" Mirena--smaller, better design, less side effects) and the FibroPlant-LNG, which is a frameless IUD (no plastic frame, far fewer side effects). Both Mirena and T-LNG14 are frame IUDs--they have a plastic, T-shaped, frame. I was comparing Mirena with the other IUDs in its group, not with IUDs in a different group (i.e., the copper-releasing IUDs).

    Again, I thought the original post at Instapundit didn’t make it clear to the lay reader that there were other IUD’s available to American women, and so I included the copper IUD in the discussion, making clear that it was different from the hormonal IUD’s. She’s right that production of Progestasert has been discontinued. But, again, I have to think it’s due to market forces, and I wouldn’t be surprised if Mirena went the same way, although it is better tolerated than Progestasert. As far as IUD’s go, though, they aren’t popular here largely because of the Dalkon shield litigation in the 1980’s. That scared everyone away - patients, doctors, and manufacturers. And again, as free and full functioning members of our society, American women are just as culpable for that state of affairs as anyone else.

    Regarding your statement that:

    And the other truth is, that there isn‚t all that much room for improvement in birth control. The pill is highly effective, well-tolerated, and easy to take. Hard to beat that.

    In the U.S., there are approximately 5.38 million pregnancies each year. About half, or 2.65 million, are unintended pregnancies. The majority of unintended pregnancies occur in women using birth control. This means approximately 1.4 million unintended pregnancies happen in women using birth control at the time that they become pregnant. It is estimated that about 1 million unintended pregnancies happen because of improper use of birth control pills. Thus, at a minimum, for about 1 million women per year in the U.S. the pill is not highly effective, well-tolerated or easy to take. Additional contraceptive options will, indeed, represent a way to "beat that".

    Well, that depends on how you define “using” birth control pills. If you mean that they have an unused pack of pills in the medicine cabinet, then they aren’t really using it, and you can’t blame the pill for the lack of efficacy. Although I can’t quote any statistics, my experience has been that women who don’t take their pills do so out of ambivalence more than out of concerns about side effects or difficulty remembering to take it. (At least that’s the case in my practice.) Women who take the pill every day as directed (something which the majority of pill users do) avoid pregnancy 99% of the time. Every form of contraception, aside from sterilization, requires some degree of compliance. Even injectables and implantables won’t be effective if the patient doesn’t show up to have them injected or replaced.

    UPDATE II: A reader emailed one more correction:

    You are correct in that Lunelle is still available. However, the following that you wrote is not quite correct.

    "As for Lunelle, it was the single dose vials that were removed from the market, after concerns about their effectiveness. Multi-dose vials were not recalled. (Although, I'll grant that multi-dose vials aren't often used.)"

    The recall of Lunelle was of the pre-filled syringes "due to a lack of assurance of full potency and possible risk of contraceptive failure." No vials were recalled. The vials are single-dose; there are no multi-dose vials. Each vial contains 0.5 mL of the combination--0.5 mL is the amount injected each month. The 0.5 mL vials are available in boxes containing 1 vial, 3 vials, and 25 vials.

    One last thing, some useless knowledge, hopefully for a smile. The inventor of the copper-eluding IUDs was a Chilean named Jaime Zipper.

    That is worth a smile.

    posted by Sydney on 3/08/2003 10:21:00 PM 0 comments


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