Friday, June 5, 2015

Flibanserin: Female Libido--Even the Score Fights to Win

J.S. Sergeant Egyptian Girl 


Here's a story which made it above the fold in today's New York Times: "FDA Panel Backs 'Viagra for Women.'"

"The move was immediately hailed by some women's organizations as a step toward sexual equality by, in effect, giving women their counterpart to Viagra, the widely prescribed drug for male erectile dysfunction."
Flibanserin 

"The controversial campaign by some women's groups to win federal approval was waged under the banner Even the Score, which accused the FDA of gender bias because it had approved Viagra and other drugs to help men have sex while leaving leaving women without options."

"Susan Scanlan, chairwoman of the Even the Score coalition, hailed the vote, saying in a statement, 'Today we write a new chapter in the fight for equity in sexual health.'"

Oh, we wrote a new chapter, but I'm not sure it was the chapter Ms. Scanlan describes.

Let us examine the many ways in which wrong has ascended here.

1. The FDA is supposed to function to protect the public health by approving drugs which have met two criteria: 1. They are safe.  2. They are effective. 
The study of 5,000 women in which half got a placebo and half got flibanserin and were then interviewed about how many satisfying sexual encounters they had had during the month was unconvincing on many levels. It is not like you can actually do a blood test and generate a number for the effect of a drug on libido. Many women will report their sexual appetite increases with a martini or two, and that can be convincing testimony, but with drugs we like to measure something beyond recall and testimony. The difference between the two groups was barely one additional night of good sex and there could have been many reasons for that. The placebo group increased their sexual encounters almost as much as the treatment group and that ought to tell us something.

2. The fact the FDA has not approved a drug to improve libido in women who have low libido does not mean the FDA doesn't care about low libido in women; it means nobody in the drug industry, at the FDA, in medicine, in endocrinology or gynecology, in the whole wide world really understands female libido. 
Males are pretty simple: give them enough testosterone and they are looking for action. 
Give women testosterone, or estrogen or any hormone you care to mention and nothing happens. 
We simply do not understand the basic physiology of female libido or the pathophysiology of it's absence.  
So, if women who lack libido were left without options, it was not because of indifference or wrong doing by the FDA.  It was because science has not provided options. The failing, you see, is not a failing of the FDA. Got that? Is that really so difficult?

Flibanserin may act on neurotransmitters, may accentuate the dopamine and dampen the serotonin but nobody really understands if or how these transmitters work in female sexual libido.  
A similar outcry arose in the early days of HIV, when activists cried out the reason there was no cure was nobody cared about gay men dying. That was untrue. The reason there was no cure was the doctors didn't know what to do. Spending more money did not solve the problem; science eventually did. Sometimes money cannot buy insight.  The response of non scientists in Congress to a problem like AIDS or almost anything scientific they don't understand is to vote for more spending, but that's because they are ignorant Congressmen.

3. Flibanserin, even if it were effective at increasing female libido would not be a female Viagra. Viagra and its fellow travelers do not increase male libido. Viagra improves erections. To have good erections you need working blood vessels, working nerves and adequate levels of testosterone. Viagra takes care of the blood flow.  Testosterone is what usually drives libido in males and there is no such agent for driving libido in women.

4. Libido is one thing, but having enjoyable sex is another. Libido is the first step down the road. We understand even less about what drives female libido in chemical terms than we understand about what allows women to achieve orgasm. 

5. Voting for approval of a drug aimed at a problem which vexes women is not the same thing as actually solving that problem, if the drug is ineffective, which, may be flibanserin's problem.  
One of the doctors who voted for approval explained: "The unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product ...seems to be the right step at this point." 
Which is to say, "We were taking a lot of heat to approve something, anything, so we caved to political pressure, even though the public health service and the FDA is not supposed to cave to political pressure. We are supposed to do the right thing."

6. People who earn their salaries by winning fights in the halls of Congress or the FDA were able to make this decision not a consideration of the science but a test of intentions and "a fight for equity in sexual health."

The fact is, I wish we had an effective pill for low libido in females. 
I wish we had an effective pill for baldness and for obesity and for breast cancer and for lung cancer and for melanoma and for diabetes and for a whole lot of problems for which we do not have cures or even effective management. 

But you cannot vote a cure for medical problems. You cannot win a fight against inequity in sexual health if there is no science to help you.  Parsing uplifting phrases does not help in medicine. 

We have allowed moneylenders in the temple when it comes to allowing Even the Score to  bully the members of an FDA panel into voting through a medication not because it works, but because it satisfies the needs of the board of directors of Even the Score.  Activists simply do not deserve a seat at the table when it comes to medicine. 

Which is not to say we should not sympathize with their cause. When Act Up picketed Building 32 at the National Institutes of Health, the head of the Institute for Allergy and Infectious Disease was Tony Fauci. (He still is head of that institute.) He walked by the pickets, took the elevator up to his office and asked his secretary why anyone would picket a building at the NIH. She told him, "They're picketing you, Dr. Fauci."  He sent for the pickets and brought the whole lot of them into a conference room and asked them what they wanted and what they expected him to do. 
They told him the reason there was no cure for AIDS was nobody cared about patients who got AIDS because it was thought of as a gay disease. 
Fauci replied he had a lot of very good scientists who were working hard on an antiviral agent both on campus at the NIH and spread out across university health centers across the country. He described the units he had set up at the Clinical Center where patients with AIDS were dying in beds attended by nurses and doctors who were risking their lives just starting IV's and doing routine care on those patients. "If you think nobody cares, you've never talked to any of the men or women who come to work every day at the Clinical Center." 
The activists listened and were convinced. They came as angry men and women with a cause; they left Fauci's office understanding anger and passion are not the answers in medicine. They had been educated in the reality of disease and the realities of medical care.

Someone should do the same for Even the Score. 



Thursday, June 4, 2015

Stepping Through the Time Portal: You Really Can't Go Home Again



So we beat on, boats against the current, borne back ceaselessly into the past.
--The Great Gatsby

At some point, probably when your own children are beyond schools and into careers and families and other people, your own past seems less important.  Scott Fitzgerald's most famous book was about a man who was ruined by his past, who could never get beyond it, but that was a pathology, a case of arrested development. 

For most people, the past does not constrain them, if they are lucky and healthy.  Deangelo, in "The Wire" reads Gatsby in prison, and immediately understands it, because he has not been able to move beyond his own past--prison, after all, is a place you are mired in the past; you are there because of things you did in the past.

The Times has been carrying obituaries of men in their late 80's and early 90's who were accused of Holocaust related crimes, but despite the determination to Never Forget, the fact is memories are fading, less so for the victims no doubt, than for the perpetrators, who may well have managed to bury and destroy memories of what they did so long ago.

People who struggled to be the winners in the game of elite educational meritocracies often cling to the past--there are those Princeton grads who will only marry other Princeton alums believing that part of the past is so important it ought to be prologue, but they are clearly clinging to a neurosis.

For most healthy people, you go through each phase of life and you take what you can from the experience, then move on, and realize, that is now behind you. That old story about the Yale coach who tells his players before the Harvard-Yale game, "Gentleman, you are about to play Harvard: If you live to be 90, you will never do anything more important than what you are about to do in this game today," was enunciating the conceit of the Old Blues who wanted to inflate the importance of a Yale education, when in fact, it was just four years at college, and for most people only marginally formative and not really life changing. William F. Buckley was particularly pathetic as he injected his Yale pedigree into every conversation to remind his listeners he was an aristocrat and one of the chosen--of course, his own pathology was transparent. 

The emphasis on schools and creating a record which will follow you through life is specious--the fact is, that great school record simply gets you from point A to point B. Once you start that next school, grad school or professional school or once you start that job, you start over, and what came before really doesn't matter much and cannot hurt you or save you.

Some of this desire to connect to the past may be at play as people visit their dead in cemeteries. There is the desire to hold on to what is actually now gone, alive only in memory. But there is no boat bearing us back. When you walk around places which were important to you in the past, it may bring those memories back vividly, but there is also the empty feeling of realizing even though the physical shell of a building may be there, it is no longer alive; that school yard or church or coliseum is just an empty husk, the hollowed out remnant of the living organism.  

We are not, should not be, borne back ceaselessly into the past. We move forward, and the wake remains behind us. The effort to return is the effort to claim something enduring in the face of impermanence. 


Sunday, May 31, 2015

Scott Walker's Really Cool Sonogram Idea



Not a Real Cowboy
Gail Collins alerts us to a remark by the governor of Wisconsin, Scott Walker, who is running for President, in defense of his support for a law which requires a woman who is scheduled for an abortion to undergo a sonogram, so she can see what it is inside her she is "killing."
Of course, the intent of this law is confront the woman with something that looks alive, looks human, looks like a miniature baby, so she will decide against the abortion.
Not An Actual Calf
But Scott Walker denies he is trying to shame or guilt anyone, and he points out that sonograms of pregnant uteri are done all the time and parents carry them on their smart phones and post copies on their refrigerators, which is a really cool part of pregnancy. The parents start bonding at six or eight weeks with their unborn children.

The problem is:   sonograms are not babies. 

They may, with some imagination, look like babies, but they do not actually even look a lot like what is inside that uterus, which is about the size of a lima bean and very red and undifferentiated looking. 

Clouds may look like babies, or cowboys or calves but they are none of these things. An image is not the object it looks like. It is just an image. 

Not An 8 Week Fetus

Sonograms magnify and schematize the objects they penetrate.

6 weeks

Not to mention, they are black and white, except for the Doppler flow parts, which are orange and blue.  They require a mental reconstruction to make anyone bond with them. 


8 weeks

As the fetus gets older, the sonogram may look more like a baby, but what they are actually imaging would surprise most people, if they actually saw the real thing imaged--at 6 weeks the conceptus looks more like a red lawn grub, fairly difficult to imbue it with much humanity, on a visual basis.
7 weeks 

And the photos here do not even really convey how much like a clot of blood much of this material actually looks like. 
Having said all this, I'll never forget seeing a 21 week fetus delivered in what was then called a "salting out" procedure when I was a medical student. That  looked like a baby to me. The procedure which was done in those days was called an "abortion" but it looked more like infanticide to me. The fetus could not have survived outside his mother's body in those days, but the reason it was outside his mother's body was because they had pumped in a concentrated salt solution into the uterus.  I found that profoundly disturbing. They whisked the thing away from the operating room so the mother did not see it. I could see why. I stood in an adjoining room with it and half expected it to take a breath. Of course, if it had been anencephalic (without a brain) I would have hoped it would never take a breath. Some deformities are so horrific, you just think it a blessing if that breath is never taken or is it's last.  
8 weeks


So, I am not in favor of everything which is called an abortion. As my favorite ethics professor once asked me, "If you meet a fetus on the way down the birth canal with a scalpel, is that an abortion?"

His point was the difference between an abortion and infanticide is all about drawing lines. 

One way of doing that is to try to assess how much potential the conceptus has actually realized and how much it is just a mass of tissue with a lot of potential, mostly unrealized. 

But showing untutored women ultrasound images is an exercise in deception. You can instruct her however you want but they haven't really been educated until they've seen the real tissue. 

The reason parents are shown all those ultrasounds in their private obstetricians' offices?  Commerce, not medicine. There is demand for those ultrasounds, but most often, no good medical reason for doing them--unless you are looking for substantial abnormalities, which might prompt a decision for...abortion.

There are no easy answers, when it comes to abortion. The only real answer is we are poorly served whenever we have simple, mindless answers. Those are almost always wrong.

One of the great virtues of absolutism is clarity and elimination of ambiguity:  If you believe life begins at the two cell conceptus, that makes everything an abortion after conception. It's simple, clear and, at least to my mind, incorrect.

Likely 40% of conceptions are lost early, before more than a thousand cell divisions, before the mother is even aware she is pregnant. Is this a natural process wasteful of life? And, if you're Catholic, what about all those souls who have not been given last rites (because nobody knew they existed in the first place)?

Abortion is not one of those topics which affords a lot of middle ground. Never has. For centuries, defining when life begins has vexed theologians. Scientists do not define when life begins. They simply describe what they see. But sometimes, what they see is not what you think you see. 




Friday, May 22, 2015

The Fig Leaf Comes to Hampton

 Let's talk about breasts. The best discussion I've ever heard about breasts was not in medical school, but from Lewis Black, who observed, in his best exasperated style, that most breasts are pretty, whether large or small, and he was perplexed about why women would undergo augmentation procedures.

Friends who are not doctors, male friends, occasionally ask me how I can resist getting turned on by my female patients, especially when I examine their breasts. Women, of course, never have to ask that question.  There is nothing arousing about a woman who is worried she might have breast cancer, and when you are focused on finding something nasty, and examining a breast and probing for lymph nodes in an arm pit, it is nothing close to an erotic experience. Frightened women are not a turn on. 

"Let me ask you, " I  usually reply, "Would a breast laid out on a stainless steel tray arouse erotic thoughts in you?"  The fact is, there is a woman attached to a breast when it becomes arousing and it is her attitude which is arousing, not the physical object, the breast.

Which brings us to a piece of folk art, a sand sculpture,  which appeared recently, on Rte 27 just before The Old Salt,  on a private lot.

The sculpture, a  mermaid, was a bit of whimsy and kitsch, and I liked it. She may have looked sensual, with her hand behind her head, and her face uplifted, but it was the pose, not the bare breasts which conveyed any sort of erotic or sensual content.  That mermaid looked happy to be in Hampton, in the water, soaking up the sun, enjoying the pleasures of our clean water, our clear, invigorating air, the sparkling, rocky beaches which we love. 

Today, however, the mermaid has acquired a bikini top or bra or fig leaf or whatever it is, and one wonders how that happened. Well, we know how what happened--there was a guy out with a trowel, apparently, but the question is: Why?



We ought to write letters to the editor, organize a protest.  Picket. Bring it up with the town elders.  Children pass by that sculpture on their school buses on the way to Marston, Hampton Academy, Winnacunet High. They have seen art defaced! This is what ISIS is doing in Syria, destroying art, defacing sculptures. 

Today, it's a mermaid in a bra; tomorrow it could be veils and head coverings for all females!  Then covered ankles and pretty soon all we'll see of women in Hampton are their eyes. 

And what of Madame Liberty?

I have an old silver dollar, (not the one shown, but like it) I've been saving, at home. Will the Hampton Police come for me in their black helicopters?  
My coin is from 1986. No so valuable

First it's breasts, then they'll come for our guns!

How quickly things get out of hand. 


Thursday, May 21, 2015

Gail Collins and Andrew Jackson and the $20 Bill



Gail Collins continues to hammer away at the $20 bill:  She argues Harriet Tubman ought to replace Andrew Jackson.

On a recent visit to Nashville, where Andrew Jackson's statue is prominently displayed, or more accurately, where many different Jackson statues are displayed, Mad Dog inquired with locals about their feelings: Aude alterum partum (hear the other side), that's Mad Dog's motto. Mad Dog was surprised to hear Mr. Jackson has his detractors, even in Nashville, which, it must be admitted is a blue island in a sea of Tennessee red. Fact is, Mr. Jackson killed enough of his fellow citizens in duels to engender much resentment among many of Nashville's local families. Nothing like shooting a great grandfather in the head to leave a bad impression.

Beyond that, General Jackson was the first and most effective American advocate of ethnic cleansing, moving Indians out of their Eastern habitat along "The Trail of Tears" which made the Bataan Death March look like a Sunday school picnic. Four thousand Indians died along the way, by somebody's count.  Suffice it to say, portraits of President Jackson do not adorn the lodges and casinos of native Americans.

Mad Dog is proud to report New Hampshire's own Jeanne Shaheen has recommended the convening of a commission to recommend a replacement for President Jackson on the $20 bill and Gail Collins likes Harriet Tubman for the spot.  Ms. Tubman risked life, limb and liberty by returning to the slave South and guiding many slaves along the underground rail way to freedom. (Presumably, Fred Rice would have paved that rail way to reduce air pollution, but that's another story.)

For Mad Dog's money, it would be Jane Addams, but this is mostly because Maud loves her so: Hull House, a place of kindness and compassion amidst unfeeling and hostile environs, and she earned J. Edgar Hoover's designation as "the most dangerous woman in America." Anyone who made J. Edgar froth and foam at the mouth has got Mad Dog's vote.

Whoever replaces President Jackson, she can hardly be worse than a slave owning, genocidal killer.

While we're at it, the commission might consider replacing Washington and Hamilton, one a slave owner and the other a banker. We could do better. Elizabeth Cady Stanton and Clara Barton should not be forgotten. 

Personally, I'd put in a vote for Emily Dickinson, although I cannot spell her name reliably, or Gloria Steinem, another spelling problem, but a worthy woman.

Tuesday, May 19, 2015

Let's Get Tough on Crime: It Always Works



I don't know who your favorite police chief is, but mine is Joe Arpaio, the toughest sheriff in America, by his own description.  

Well, actually, my favorite police is Howard Colvin, the Baltimore police captain who established a zone in Baltimore where drugs could be freely bought and sold, but, as I have to keep reminding myself, Colvin is not a real police, just a character on the Wire. He should be a real police, but that's another story.

So, by default, among actual, real police, Sheriff Arpaio has to take the prize. He is so tough he has a tank of his own, which he uses, I'm sure, effectively, to crack down on the drug trade, prostitution, burglary, muggings and murders.  

He doesn't just jail miscreants, he humiliates them. Those arrested, awaiting trial, are apt to find themselves marching down Arizona streets wearing nothing more than pink underwear. If, at trial, they are acquitted, presumably, they can keep the underwear, which is said to be of high quality.

This is not, for reasons known only to Sheriff Arpaio and the Supreme Court, not cruel and unusual punishment, prior to conviction. It's better than strip searching, but actually, it is used after the strip search.




I recently spoke with the mayor of a Southern city about the reasons for declines in the murder rate in his and other cities. This mayor was a former defense attorney, and he believes the "broken windows" tact of policing accounts for some of the decline.  This doctrine is a variation of the "take care of the pennies and the dollars will take care of themselves."  If you arrest people for looking funny at the police, or for walking while Black, then you will decrease major crime acts. 

My own father always insisted the reason for falling crime was the aging population. Most violent crime is committed by stupid (i.e. young) people.  The authors of Freakonomics had a version of this: They claimed the fall in crime could be traced to the legalization of abortion, which meant a lot of kids who were never wanted were never born and were not roaming the streets killing people.  Either way, it had to do with simply making the population which tends to be violent shrink in size. 

Of course, we all know the real reason for the falling violent crime rate: Tanks and Humvees. Give the police the means to do shock and awe in our towns and cities and those violent criminals take to their heels and get out of Dodge. Where they go, we can only imagine, but it must be very violent there.

President Obama, of course, as usual is clueless about all this, which is why he is denying local police departments the tanks and aircraft carriers they so urgently need. 

If there is a spike in violent crime, we'll know who to blame and he lives at 1600 Pennsylvania Avenue and his name rhymes, significantly, with "Osama."



Thursday, May 14, 2015

Refugees


Somalian Women


Not Good Husband Material 
Some of us recall the stories our grandparents told about why they left wherever they came from, be it Ireland or Russia  or wherever, when we hear stories about new immigrants in the United States or when we see stories about boats packed with Africans going down in the Mediterranean.  For us, there is a sort of built in sympathy, or a bias in favor of those trying to move from a bad place to someplace better or simply to anywhere else. 

Apart from African slaves brought against their will to America, some Canadians, and the "Native Americans" who may have trekked across the the Bering Straight following herds, almost all the rest of our ancestors crossed the oceans or the rivers because they were running from something bad. 

We now have refugees from Somalia in Manchester, New Hampshire.  As war or chaos grips a country, those who can will go from an area of badness to one of less badness, just as water will cross an osmotic membrane from an area of dilution to an area of concentration. It's a law of nature.  Some people in possession of deranged brains, Congressman Louie Gohmert comes to mind, but there are many like him, will tell you the appearance of these unfortunates among us is something alarming and threatening, a plague, an upsetting of a vital balance.  But these are minds which live in a constant state of alarm.  Any change is a pestilence, for them.

More generous souls will listen to the newcomers and often be moved to try to help, to the extent they can.

One of my neighbors has been traveling from her home in Hampton to Manchester to teach a Somalian woman to write and how to sign her name. The Somalian has recently learned to read and that opened up a new world to her and my neighbor was stunned to think what that must be like, to learn to read as an adult, how life would never be the same. This Somalian, being a woman in a Muslim country, was never allowed to go to school. But now, in the United States, she has learned to read. 

Of course, it was a serious crime in the antebellum South to teach a slave to read. Slave society knew, instinctively, reading was a genuine emancipation, and much as slave society told itself (and everyone else, ) these slaves were sub human, dim witted, child like, the slavers knew reading would be more dangerous than almost anything than a gun in the possession of slaves.

A urologist gave a presentation at a conference about her work in Africa--may have been Somalia--concerning urinary incontinence in women.  In this African culture, girls are married at age 9  impregnated as soon as they reach puberty, at age 11 to 12, when their pelvises were not wide enough to deliver a baby and the delivery so traumatizes their urethra's, they are left incontinent forevermore. This meant they have a constant stream of urine running down their legs to their feet, causing infections of their feet, not to mention an odor which led to ostracism.  The urologist perfected a simple operation to repair the damage and give a life back to some of the lucky few she could reach and treat. 

Of course, the urologist was not treating the basic pathology--a culture in which 9 year old girls are married off, used for sex  and impregnated as soon as they start ovulating.

My New Hampshire friend cannot fix the basic pathology, which is fomented across the sea,  which, in some ways, still afflicts her Somalian friend, but this Granite Stater is doing what she can, and that's where a better world begins. 

It is left to the rest of us to take the bigger steps in behalf of those refugees who reach us. We cannot solve the problems where they start--in Africa, but we can stanch the wounds of those who reach our tent.