Friday, June 5, 2015

Flibanserin and the Politics of Medicine

After huge pressure, an FDA panel has approved the drug flibanserin to treat the lack of sexual desire in women. This has been very controversial because the positive effects of flibanserin barely meet the standard of statistical significance, and it comes with serious side effects (low blood pressure, fainting, dizziness, nausea).

In this case the usual lobbying by a manufacturer in search of fat profits was supported by a coalition of women's groups who call themselves Even the Score:
which accused the F.D.A. of gender bias because it had approved Viagra and other drugs to help men have sex while leaving women without options. The participants in the campaign had been brought together by a consultant to Sprout Pharmaceuticals, the developer of flibanserin.
I think this is crazy. Viagra treats a physical inability to have sex, not a lack of desire; without desire it makes no sense to take Viagra. Women's desire for sex is, as all men of my generation have been hearing since we were 16, a hugely complicated thing all wrapped up with emotions and relationships and so on. I suppose the point is that many women have lost desire even when all the things that used to make them hot are there, which implies some sort of physiological factor. Maybe. But if that is true, flibanserin isn't the cure, since as I said it performs only a little better than placebos in the biggest trials.

The positive way to spin the FDA panel's decision would be like this:
The unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product with strong limitations seems to be the right step at this point.
But you could also wonder why we are always looking to drugs to solve our problems, and why we are always blaming complex physiological or technical problems on Bad People -- we don't have a male pill because of sexism! we don't have affordable electric cars because of oil companies! If any company came up with a drug that would make women want and enjoy sex, they would earn billions overnight; since no such drug exists despite the huge incentives, this must be a very hard problem. Lobbying and wishful thinking will not solve it.

4 comments:

  1. "Viagra treats a physical inability to have sex, not a lack of desire; without desire it makes no sense to take Viagra."

    You're confusing "desire" and "libido". Flibanserin doesn't create the desire for sex. It simply enhances the libido - it facilitates the biological response of physical arousal. It treats the exact same problem as viagra.

    A man can desire sex, but be unable to become physically aroused. His body chemistry simply isn't correct - his biology fails to function properly, despite personal wants.

    The exact same thing is true of women. A woman can desire sex, but be unable to become phnysically aroused. Her body chemistry simply isn't correct - her biology fails to function properly, despite personal wants.

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  2. "But you could also wonder why we are always looking to drugs to solve our problems, and why we are always blaming complex physiological or technical problems on Bad People

    Drugs solve problems. That is literally what they do. And they make people's lives objectively better in doing so.

    If you come to me with a new drug that solves - or even just helps with - a problem that previously had no remedy, I'm all for it. Having more options available to us is always preferable - even if we have to be judicious about when and how we use those options.

    The problems we humans have with drugs don't come from their use, but from their abuse. Exploitation of our fellow humans - typically in form of the exploitation of poor human judgement - is the root evil at work here. And the kind of people who manipulate the availability and usage drugs to exploit others for profit are exactly the "Bad People" you seem to be dismissing as imaginary.

    "-- we don't have a male pill because of sexism! we don't have affordable electric cars because of oil companies!"

    You jest, but in actuality for generations we DIDN'T have certain drugs because of sexism. (And yes, oil companies have at times actively pushed to hinder the development of electric cars. They are, of course, NOT the primary reason such technology is still unfeasible, but they have certainly demonstrated a ready willingness to have been said reason, if it had been necessary.)

    Drug usage his a long and storied history of sexual bias. Drinking and smoking were for rather a long time completely unacceptable - even at times illegal - behaviors for women, despite their being quite a large market to sell into. Birth control has existed in a variety of forms for well over a century, but it was widely outlawed in the aftermath of the American Civil War and only as recently as the 1970s did all Americans win the right to legal access, despite more than ample demand and ready capacity for supply.

    If any company came up with a drug that would make women want and enjoy sex, they would earn billions overnight; since no such drug exists despite the huge incentives, this must be a very hard problem."

    This may surprise you, but women do want and enjoy sex. Your notions otherwise are, I suspect, the product of your self-admitted generational indoctrination - for which you have my sympathies.

    You suggest that untapped drug markets would be an absurdity, that capitalism abhors a vacuum, but as I mentioned above, for generations of women eager for drugs that could easily have been supplied to them, such untapped markets were the historical reality.

    Why? For the same reason women were once denied the vote; for the same reason they were once denied the right to own property; for the same reason they are still today denied equal pay, and why . For the sake of control. For the sake of the continued cultural dominance of patriarchy.

    You think this new drug being made available is crazy? People once thought the same thing about women wearing pants and riding bicycles.

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  3. Barring substantial side effects, I see no reason for this drug not to be made available.

    On that note, I feel it would be informative to list the absolutely staggering amount of potential side effects of Viagra - some of which are absolutely terrifying - for comparison. (Source http://www.drugs.com/sfx/viagra-side-effects.html)

    More common

    Aches or pains in the muscles
    bloody nose
    diarrhea
    difficult or labored breathing
    flushing
    headache
    pain or tenderness around the eyes and cheekbones
    redness of the skin
    sneezing
    stomach discomfort following meals
    stuffy or runny nose
    trouble sleeping
    unusually warm skin

    Less common

    Bladder pain
    burning feeling in the chest or stomach
    burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
    cloudy or bloody urine
    dizziness
    increased frequency of urination
    indigestion
    pain on urination
    stomach upset
    tenderness in the stomach area

    Rare

    Abnormal vision
    Abdominal or stomach pain
    abnormal dreams
    anxiety
    behavior change similar to drunkenness
    bleeding of the eye
    blurred vision
    bone pain
    breast enlargement
    chest pain
    chills
    clumsiness or unsteadiness
    cold sweats
    confusion
    convulsions (seizures)
    cool and pale skin
    cough
    deafness or hearing loss
    decrease in amount of urine or the frequency of urination
    decreased vision
    diarrhea or stomach cramps (severe or continuing)
    difficulty in concentrating
    difficulty in swallowing
    dizziness or lightheadedness, especially when getting up from a lying or sitting position suddenly
    double vision
    drowsiness
    dry eyes
    dry mouth
    dryness, redness, scaling, or peeling of the skin
    ear pain
    excessive hunger
    eye pain
    fainting or faintness
    fast, irregular, or pounding heartbeat
    feeling of something in the eye
    fever or chills
    headache (severe or continuing)
    increase in the size of the pupil
    increased amount of saliva
    increased skin sensitivity
    increased sweating
    increased thirst
    lack of coordination
    loss of bladder control
    lower back or side pain
    mental depression
    migraine headache
    nausea (severe or continuing)
    numbness or tingling of the hands, legs, or feet
    nervousness
    nightmares
    numbness of the hands
    painful, swollen joints
    prolonged, painful erection of penis
    rectal bleeding
    redness, burning, or swelling of the eyes
    redness, itching, or tearing of the eyes
    redness or irritation of the tongue
    redness, soreness, swelling, or bleeding of the gums
    restless sleep
    ringing or buzzing in the ears
    seeing shades of colors differently than before
    sensation of motion, usually whirling, either of one's self or of one's surroundings
    sensitivity to light
    sexual problems in men (continuing), including failure to experience a sexual orgasm
    shakiness
    skin lesions with swelling
    skin paleness
    skin rash, hives, or itching
    skin ulcers
    sleepiness
    slurred speech
    sore throat
    sores in the mouth and on the lips
    sudden weakness
    swelling of the face, hands, feet, or lower legs
    tense muscles
    trembling and shaking
    trouble breathing
    twitching of the muscles
    unusual feeling of burning or stinging of the skin
    unusual tiredness or weakness
    vision changes
    vision loss, temporary
    vomiting
    waking to urinate at night
    worsening of asthma

    Incidence not known

    Blindness

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  4. G.Verloren, whoever you are (female or male) - kudos to you. I couldn't have said it better.

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