Today the New York Times has an article about what appears to be the first successful "microbicide" that protects against HIV infection in women. Many hosannahs have been said in the medical & scientific research circles following the release of this data. No less an authority than Anthony Fauci, the head of the National Institute of Allergic and Infectious Diseases (and someone Billy thinks of as a patron saint of the profession), noted, "there’s a certain feeling of ease and pleasure for me as a scientist that any way you slice the data, it’s statistically significant." That may not sound like much, but in doctor-speak that's a pretty excited endorsement.
The "microbicide" is a vaginal gel that the woman applies both before and after having sex, and it provided protection between about 40 and 50 percent of the time (the amount varies because the researchers broke down the cohort into sub-groups based on how faithfully they applied the gel; the more faithful users, not altogether surprisingly, were better protected). That's it--the gel hardly constitutes complete protection, but previous studies have shown dismal results.
You might be tempted to ask about condoms: why not just use them? Aren't they much more effective? This depends on how you mean "effective." If you actually use a condom, then yes, it's in fact a very effective means of protection for both partners. The problem is most men, whether they're having sex with other men or with women, don't like condoms and try to avoid using them at all costs. (I'm certainly no fan of them.) So out in the real world, where the vast majority of people aren't enrolled in a clinical trial, a condom isn't actually especially effective, because it often remains on the shelf, or in the purse, or in someone's back pocket, sometimes with the owner having the best of intentions, or as the case may be, because one partner persuaded the other not to use it (regardless if the sex is "gay" or "straight"). So the gel can provide extra protection for a woman who has a partner or partners unwilling to wear The Sock. (There's some very preliminary data suggesting the gel may be protective for men in anal intercourse, but this study looked exclusively at women.)
The trial enrolled nearly 900 African women. Now, however, the trial is over. The study was funded largely by the US Government. The question is, what is the obligation that the researchers, backed by the US, have to the patients? Is it ethical to simply walk away from these patients and allow them to be at "baseline" risk of acquiring the virus--which is still largely a death sentence in Africa? Or are the researchers only obliged to enter into an agreement which ceases to be at the end of the trial? These women, after all, would mostly have become infected had they not enrolled in the trial. On the other hand, what if a microbicide is developed as a result of this trial and becomes available outside of Africa first? Does that seem fair? Shouldn't the women who "put their bodies on the line for this study" (in the words of AIDS activist Mark Harrington, quoted in the article) have first dibs on the gel?
These are not idle questions and such situations have occurred many times throughout the past 60-70 years in US medical research. Most readers will be familiar with the infamous Tuskeegee Experiment, but many other similar experiments have taken place precisely because nobody designing the trial took the kind of questions above into account. I don't mean to imply that these researchers didn't; I can only say I am concerned by the Times report. In my own field, the "intervention" we study is almost always a vaccine, and if that works you don't need to come back for more; this situation is different.
Typically, the Billy Rubin Blog tries to leave you with an opinion. Tonight I only have questions--those questions two paragraphs above, in addition to more in that vein running through my head right now--and can leave you only with a troubled shrug of my shoulders.
--br
Where a spiritual descendant of Sir William Osler and Abbie Hoffman holds forth on issues of medicine, media and politics. Mostly.
Monday, July 26, 2010
Wednesday, July 21, 2010
Rambling Reintroduction
My most recent post, alas, dates back to the election of Scott Brown to the US Senate, with a fairly prolonged harangue at President Obama and my various frustrations with him (frustrations which, I am sad to say, have if anything only increased).
Not long after that entry my father collapsed on a winter's afternoon in Columbus, Ohio while walking out to his mailbox. Though the cause is unclear, he was in cardiac arrest by the time the EMTs arrived about five to ten minutes later on the scene after a neighbor witnessed the collapse and called 911. My father would not have wanted this, though of course the neighbor could not have known that. The EMTs were able to revive him and brought him back up the street to the local hospital to "stabilize" him. My mother, needless to say, was in total shock; I was seven hundred miles away, while my older sister was twice that distance in the opposite direction--in short, not the best situation to be in for a reasonably loving & mutually supportive family to make difficult medical decisions.
There are some details which at this very moment seem tedious to recount--tedious only in that retelling them in a blog (whose readers I cannot see and may not know) ain't really why I'm writing this. Suffice it to say that my father passed away ten days after he collapsed, although as far as I am concerned, in what some readers may regard as complete heartlessness, he finished his just-too-brief stint on earth that early February day he went ambling out to peruse his bills & other ephemera.
He had just turned 76. I would have loved ten more years with him, I would have settled for five, but I have no gnawing regrets losing him when I did. And while I didn't much enjoy the ten days we spent watching the corporeal shell of what used to be my father stop functioning, overall I don't have many complaints. Pops went from being a fully functioning guy, totally independent and in control of every aspect of his life, to dead, and made that transition quickly and without prolonged suffering. As a son, I think "ah, couldn't I have just a little more time?" As a doc, all I can think is "Bravo!"
I haven't written over the past six months for a variety of reasons, but I would be a fool if I said that his death wasn't the major factor. My father hasn't been a major part of my day-to-day life for many years now, and I have not been depressed about his loss, though I have been sad to be sure. The act of writing, and writing about medicine in particular, has always served to connect me with my father. I think he was proud of me as a son for a variety of things in the general way that parents are (hopefully, anyway) proud of their children, but my father looked at my writing as something different entirely. He was my greatest reader. He loved it when I put pen to paper, so to speak, and I think he was a bit disappointed in me when I chose to pursue medicine as a career in my mid-twenties, hoping that I would become a professional writer.
Instead, I went my own way, although the writing bug has always remained with me. Since medical school nearly everything I have written has dealt with medicine, and I believe reading this work was more complicated and ambiguous for him: he really did love to read my stuff, but just never quite believed that I thought of myself as a doc, thinking I was pulling the wool over everyone's eyes. For a very long while I agreed with that assessment, but for many years I have considered myself to be at one with the stethoscope, part of the brotherhood and sisterhood as it were, and have made my peace with those decisions I made nearly half a lifetime ago. But to pick back up and blog on the issues that mean so much to me as a doc was just not something I could find the motivation to do until this evening.
Nothing special or magical has taken place tonight; this has been gestating for awhile (an odd metaphor for a son writing about his father, but still) and I've been considering getting back in the saddle for the past few weeks. I do not know how many readers I had when I was trying to get thoughts out weekly, and I assume that if I will continue again I will be starting back from nothing. But the time seems right for a stab at it.
I have spent the past month as a "teaching attending"--a somewhat odd practice at my medical school where the attending responsible for the education of the residents and students is frequently not the same doctor as the one responsible for the welfare of the patients. Regardless, I've thoroughly enjoyed the month and gotten a real kick out of observing younger physicians at a time of their professional lives that I haven't witnessed up close for many years. As the month got close I had a blank wall on my office (that I had just recently inherited) so I was eager to put up pictures, so that my students and residents could see what was important to me as a doc. Some docs like to display their diplomas and accolades, which is definitely not my speed. Others coat their walls in family pictures, also something I'm not eager to do. (A few visual reminders of one's kids? Sure. I'm just not looking to completely morph my personal and professional life to that degree.)
No, I wanted something like a "hall of fame," a sampling of the people whose stories in medicine have been important to me as I've grown up, my way of saying, "these are the models I hold up as exemplary, I hope you find your own too." There's Edward Jenner, of course--a pompous addition, perhaps, but after all the father of vaccinology (my field of work); he resides next to a pic of Henrietta Lacks, the African-American woman whose cervical cancer was "harvested" to become one of the first, and to this day most important, cell lines in modern medicine, the "HeLa" cells (and the subject of Rebecca Skloot's great book The Immortal Life of Henrietta Lacks); sharing the triptych with them is the granddad of modern dengue research, Albert Sabin (most people know Sabin for his work on polio, but that's not why he's on the Rubin wall). Over there on his own is Hamilton Naki, as triumphant a story in medicine as can be told, in my opinion, and he hangs out in the vicinity of Gerhardt Domagk (one of the "discoverers" of sulfa, who refused to join the Nazi Party during World War II even though all of his scientific colleagues jumped on that bandwagon) and Oswald Avery (one of the pioneers of influenza research).
I'm planning on adding some faces as time goes on but I think that's a good start for my hall of fame. However--and I pray that this doesn't come across as too smarmy--these impersonal heroes and heroines of mine all share wall space with my father, who never quite knew what to make of my later-in-life interest in medicine but never failed in being supportive (very much along with my mother, lest anyone misunderstand). It's a picture of him that was taken when he was a young man and I had never seen it before; it popped up when mom sent me some tributes about him. I don't regard myself as one easily given over to sentimentality, but frankly I think he belongs there up on that wall, not simply because he was my father but because he shaped me as a doctor--willingly, eagerly talking to me about what mattered to me in medicine, probing my ideas, challenging my perspectives, all the while not quite believing that his son chose such a path, but satisfied with the choice nevertheless.
I can't say for certain at this point if the Billy Rubin Blog is "back," but I can say the itch has returned. See you back sometime, perhaps.
--br
Not long after that entry my father collapsed on a winter's afternoon in Columbus, Ohio while walking out to his mailbox. Though the cause is unclear, he was in cardiac arrest by the time the EMTs arrived about five to ten minutes later on the scene after a neighbor witnessed the collapse and called 911. My father would not have wanted this, though of course the neighbor could not have known that. The EMTs were able to revive him and brought him back up the street to the local hospital to "stabilize" him. My mother, needless to say, was in total shock; I was seven hundred miles away, while my older sister was twice that distance in the opposite direction--in short, not the best situation to be in for a reasonably loving & mutually supportive family to make difficult medical decisions.
There are some details which at this very moment seem tedious to recount--tedious only in that retelling them in a blog (whose readers I cannot see and may not know) ain't really why I'm writing this. Suffice it to say that my father passed away ten days after he collapsed, although as far as I am concerned, in what some readers may regard as complete heartlessness, he finished his just-too-brief stint on earth that early February day he went ambling out to peruse his bills & other ephemera.
He had just turned 76. I would have loved ten more years with him, I would have settled for five, but I have no gnawing regrets losing him when I did. And while I didn't much enjoy the ten days we spent watching the corporeal shell of what used to be my father stop functioning, overall I don't have many complaints. Pops went from being a fully functioning guy, totally independent and in control of every aspect of his life, to dead, and made that transition quickly and without prolonged suffering. As a son, I think "ah, couldn't I have just a little more time?" As a doc, all I can think is "Bravo!"
I haven't written over the past six months for a variety of reasons, but I would be a fool if I said that his death wasn't the major factor. My father hasn't been a major part of my day-to-day life for many years now, and I have not been depressed about his loss, though I have been sad to be sure. The act of writing, and writing about medicine in particular, has always served to connect me with my father. I think he was proud of me as a son for a variety of things in the general way that parents are (hopefully, anyway) proud of their children, but my father looked at my writing as something different entirely. He was my greatest reader. He loved it when I put pen to paper, so to speak, and I think he was a bit disappointed in me when I chose to pursue medicine as a career in my mid-twenties, hoping that I would become a professional writer.
Instead, I went my own way, although the writing bug has always remained with me. Since medical school nearly everything I have written has dealt with medicine, and I believe reading this work was more complicated and ambiguous for him: he really did love to read my stuff, but just never quite believed that I thought of myself as a doc, thinking I was pulling the wool over everyone's eyes. For a very long while I agreed with that assessment, but for many years I have considered myself to be at one with the stethoscope, part of the brotherhood and sisterhood as it were, and have made my peace with those decisions I made nearly half a lifetime ago. But to pick back up and blog on the issues that mean so much to me as a doc was just not something I could find the motivation to do until this evening.
Nothing special or magical has taken place tonight; this has been gestating for awhile (an odd metaphor for a son writing about his father, but still) and I've been considering getting back in the saddle for the past few weeks. I do not know how many readers I had when I was trying to get thoughts out weekly, and I assume that if I will continue again I will be starting back from nothing. But the time seems right for a stab at it.
I have spent the past month as a "teaching attending"--a somewhat odd practice at my medical school where the attending responsible for the education of the residents and students is frequently not the same doctor as the one responsible for the welfare of the patients. Regardless, I've thoroughly enjoyed the month and gotten a real kick out of observing younger physicians at a time of their professional lives that I haven't witnessed up close for many years. As the month got close I had a blank wall on my office (that I had just recently inherited) so I was eager to put up pictures, so that my students and residents could see what was important to me as a doc. Some docs like to display their diplomas and accolades, which is definitely not my speed. Others coat their walls in family pictures, also something I'm not eager to do. (A few visual reminders of one's kids? Sure. I'm just not looking to completely morph my personal and professional life to that degree.)
No, I wanted something like a "hall of fame," a sampling of the people whose stories in medicine have been important to me as I've grown up, my way of saying, "these are the models I hold up as exemplary, I hope you find your own too." There's Edward Jenner, of course--a pompous addition, perhaps, but after all the father of vaccinology (my field of work); he resides next to a pic of Henrietta Lacks, the African-American woman whose cervical cancer was "harvested" to become one of the first, and to this day most important, cell lines in modern medicine, the "HeLa" cells (and the subject of Rebecca Skloot's great book The Immortal Life of Henrietta Lacks); sharing the triptych with them is the granddad of modern dengue research, Albert Sabin (most people know Sabin for his work on polio, but that's not why he's on the Rubin wall). Over there on his own is Hamilton Naki, as triumphant a story in medicine as can be told, in my opinion, and he hangs out in the vicinity of Gerhardt Domagk (one of the "discoverers" of sulfa, who refused to join the Nazi Party during World War II even though all of his scientific colleagues jumped on that bandwagon) and Oswald Avery (one of the pioneers of influenza research).
I'm planning on adding some faces as time goes on but I think that's a good start for my hall of fame. However--and I pray that this doesn't come across as too smarmy--these impersonal heroes and heroines of mine all share wall space with my father, who never quite knew what to make of my later-in-life interest in medicine but never failed in being supportive (very much along with my mother, lest anyone misunderstand). It's a picture of him that was taken when he was a young man and I had never seen it before; it popped up when mom sent me some tributes about him. I don't regard myself as one easily given over to sentimentality, but frankly I think he belongs there up on that wall, not simply because he was my father but because he shaped me as a doctor--willingly, eagerly talking to me about what mattered to me in medicine, probing my ideas, challenging my perspectives, all the while not quite believing that his son chose such a path, but satisfied with the choice nevertheless.
I can't say for certain at this point if the Billy Rubin Blog is "back," but I can say the itch has returned. See you back sometime, perhaps.
--br
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