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    "When many cures are offered for a disease, it means the disease is not curable" -Anton Chekhov

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    Wednesday, December 07, 2005

    Bioterror/Pandemic Preparedenss: How are we doing? Not so good, according to a "non-profit and nonpartisan" watchdog group, Trust for America's Health :

    The group gave a C to the Strategic National Stockpile, the CDC's cache of medications, vaccines and emergency surgical supplies. It gave a C- to the federal government's pandemic flu planning and its surveillance program for dangerous pathogens, and a D for lack of coordination among federal health agencies and for the government's Katrina response. The Smallpox Initiative got a D-.

    Weicker said grades are low because the federal response to public health challenges has been sluggish. He and others with his group say grades can improve if federal and state governments publicize all disaster plans and invite the public to participate in emergency planning.

    'We've conducted these series of studies ... to provide a tool to help the nation move forward in an all-hazards strategy,' said Shelley Hearne, executive director of the group. 'We've had a long string of reality calls out there, from Katrina to SARS to anthrax.' She said a majority of states are woefully unprepared. On 10 key measures of preparedness, New York met 7. There are BSL-3 (bio-safety level-3) laboratories in the state capable of handling and identifying potential killer pathogens. New York also has infection control experts available within 15 minutes' notice, a key indicator of preparedness, according to the report. Most states received a 5 or less. Delaware, South Carolina and Virginia scored the highest, with a rank of 8. The lowest were Alabama, Alaska, Iowa and New Hampshire, with 2.

    I'm glad somebody's watching and speaking up about this. It wasn't until the government started emphasizing the pandemic influenza threat that public health officials got behind the call for preparedness - and pandemic flu and bioterrorism preparedness are of the same cloth. In many ways they'll require the same sort of response. Now, the question is, is anyone listening?

    Trust for America's Health's website is here, and while it seems to be an organization devoted to tracking the state of all sorts of diseases, from asthma to obesity, the need to track states' preparedness for true public health emergencies - i.e. infectious diseases both natural and terrorism-related - is a very real and urgent need. Glad they're doing it. You can also check on your state's preparedness at the site. My state isn't doing so good.

    UPDATE: Chuck Simmons is skeptical about avian flu, and emails:

    Preparedness is a nice thing. But no one wants to pay to be prepared for 100% of the eventualities. The military is never funded to fight every potential war. Public health agencies aren't funded to fight a once in a life time pandemic. That's reality.

    Every critic of preparedness is selling something, even if his or her expertise. None of these critics can explain why the bird flu will be another Spanish Flu and not another swine flu. But, they'll offer to study it if they can get funding.

    I did a presentation on bird flu for my ambulance corps. My suggestions to the members were an annual flu shot and a pneumonia vaccination.

    I don't doubt that we will have, someday, another flu pandemic. I just doubt that anyone can predict its severity or its start date.

    posted by Sydney on 12/07/2005 08:54:00 AM 0 comments

    Medical Men of History: Here's an obscure former army surgeon with an interesting history - Dr. Leonard Wood:

    Born of impoverished Mayflower descendants in 1860, Wood grew up in rural Massachusetts and graduated from Harvard Medical School. He was fired for insubordination from his hospital internship and had no choice but to sign up as an assistant Army surgeon in 1885. His first assignment was in the still-wild West, where he took part in an expedition to recapture renegade Apaches led by Geronimo.

    In an epic feat of endurance, a small number of troopers covered more than 3,000 miles, mostly on foot. Wood emerged as an iron man who could not be stopped by lack of food, extremes of heat and cold, or even a spider bite that left his leg badly infected. His feats of endurance won him a Medal of Honor and an officer's commission.

    Before long, he wound up in Washington, where he showed a talent for making friends such as President Grover Cleveland and Assistant Navy Secretary Theodore Roosevelt. When war broke out with Spain in 1898, the restless surgeon seized a chance to leave his medical career behind. He became commander of the First Volunteer Cavalry, the Rough Riders, with Roosevelt as his No. 2.

    After that, he served as governor of Santiago City in Cuba:

    As befits a medical man, Wood's most impressive achievement was his war on tropical disease. He began by cleaning up unsanitary conditions, at gunpoint if necessary, and ended up by supporting a medical commission whose investigations found that yellow fever and malaria were spread by mosquitoes. In 1900, more than 1,000 people died of malaria in Havana; within a few years not a single death was recorded.

    He tried to run for president, too, but lost the primary maneuvering to Warren G. Harding.
    posted by Sydney on 12/07/2005 08:40:00 AM 1 comments

    Tuesday, December 06, 2005

    Grand Rounds: Doctor Charles hosting today, in his examining room. Lots of good medical blogging going on there today, so head on over.

    posted by Sydney on 12/06/2005 09:38:00 AM 0 comments

    Avian Flu Update: NPR had an excellent piece yesterday about influenza vaccine production. The number of birds required to produce the eggs is astounding. And Sanofi-Pasteur, at least, is expanding its facilities to make more flu vaccine by the old method.

    Meanwhile, Michael Fumento reviews efforts to make a better, faster flu vaccine against avian flu.

    Researchers say that chest x-rays of people with avian flu show widespread infection in the lung and destruction of lung tissue, which explains its lethality:

    "On chest x-rays in patients with avian flu, the most common abnormality we found was multifocal consolidation, which usually represents pus and infection in patients with fever and a cough," said Nagmi Qureshi, F.R.C.R., a fellow of thoracic radiology at the University of Oxford in England. "We also discovered that the severity of these findings turned out to be a good predictor of patient mortality."

    The investigators studied 98 x-rays of 14 patients admitted to Ho Chi Minh City Hospital in Vietnam after testing positive for avian flu. They assessed the x-rays for features commonly seen in chest infection and then looked for associations between x-ray appearances and mortality. Of the 14 patients studied, nine patients died and five survived.

    Three of the five patients who survived underwent computed tomography (CT) exams after discharge from the hospital. CT images showed that even though the patients' respiratory symptoms had abated, the abnormal appearance of the lungs persisted, suggestive of scar tissue formation.

    Dr. Qureshi described the findings as similar to what was seen previously in patients with severe acute respiratory syndrome (SARS). "The appearance of multiple accumulations of infection in the lung is found in both avian flu and SARS," Dr. Qureshi said. "However, additional abnormalities we discovered in avian flu patients—including fluid in the space surrounding the lungs, enlarged lymph nodes and cavities forming in the lung tissue-were absent in patients with SARS."

    To date, there have been 133 cases of human avian flu infection and 68 deaths, all in southeast Asia. Though some fear the virus has already mutated to become more infectious, the numbers don't support it.

    The incidence of plain old normal flu, remains very low so far.
    posted by Sydney on 12/06/2005 07:24:00 AM 0 comments

    Jellyroll Morning: This has nothing to do with medicine, but I ran across this NPR segment on Jelly Roll Morton while looking for a link to their flu vaccine series and just couldn't resist. When my second son was younger and whinier, I used to play him the Winin' Boy Blues - a clean version of it, anyway. He still whines sometimes, and when he does, the other kids will start singing "I'm a winin' boy, don't deny my name." It always stops him cold.
    posted by Sydney on 12/06/2005 07:05:00 AM 0 comments

    Spending Up: The Wall Street Journal's Brendan Miniter on the expansion of Tricare, the military's healthcare benefits program:

    Tricare isn't insurance, the government pays for every doctor visit and prescription and collects no premiums, only a small annual enrollment fee. Thus enlarging the program also enlarges the claim on taxpayers' wallets. Expanding it to cover seniors has helped fuel a 500% increase in prescription drug costs since 2001. The cost of Tricare Reserve Select hasn't yet hit the budget, but the tab for the entire program has been steadily rising and is now $19.8 billion, up from about $13 billion a few years ago. Opening it to all reservists will add an estimated $4.6 billion over the next few years.

    One problem is an incentive to overuse or abuse the system. Congress hasn't raised annual fees ($230 for an individual and $460 for a family) since the program began in 1996. With each passing year Tricare becomes a cheaper alternative to health insurance. Some employers even pay eligible employees to enroll because that's less expensive than putting them on the company plan. By 2011, an estimated 87% of military retirees under 65 will be enrolled in Tricare, up from 64% today. At about that time 75% of Tricare's budget will be eaten up by retirees. Soldiers actually fighting the war on terror will get whatever is left.

    Instead of addressing this issue with reforms that would prevent Tricare from consuming other parts of the Pentagon's budget, Congress has been on a spending binge. Over the past four years, Congress has added about $90 billion in personnel benefits to what the President has asked for in military spending. So in the budget now being debated on Capitol Hill the Pentagon will spend almost as much on personnel costs ($129 billion) as it will to buy and design the goods it needs to fight a war ($148 billion).

    This year alone the military will spend about $28 billion on benefits Congress has added just in recent years, which is more than it will spend to buy aircraft and ammunition.

    I've found my Tricare population to be reluctant consumers of healthcare - unlike some other health insurance subscribers (namely HMO members, who are enthusiastic users of it), so that 500% increase in drug costs is quite impressive.
    posted by Sydney on 12/06/2005 06:55:00 AM 1 comments

    Monday, December 05, 2005

    Rogue Researcher: Is it ethical to charge patients money to participate in research?

    Last year, the dermatologist from Menlo Park made headlines with his clinical study about his super-duper lotion, ``Nuvo,'' that one slathers on and then dries to kill the little buggers by suffocation.

    Now, in a letter to be published today in the journal Pediatrics, he admits his special goo was an over-the-counter skin cleanser available at just about every drugstore in the nation for under 10 bucks.

    His price for his clinical trials? More than $200.

    Why do you have to charge $200 to enroll someone in a clinical trial? Wouldn't charging them for an office visit to check on the treatment's progress make more sense? (Though it would be less profitable.) And what about people treated with placebo?

    In this case, the doctor says he had three reasons for doing his research:

    ``No. 1, I like a challenge. No. 2, if I make a better louse trap -- ha ha -- I could make some money. And No. 3, I'm Jewish. And there's a principle in the religion that there's an obligation to improve the world.

    ``I said I'm going for it. Two out of three ain't bad.''

    That still doesn't explain why he charged his subjects $200 for the privilege of being in his study. Maybe he did get 3 out of 3 after all.

    The product he used was Cetaphil Gentle Skin Cleanser, which apparently suffocated the lice if allowed to dry on the hair before washing. It certainly didn't cost $200 to provide the soap to the families.

    I'm not a subscriber to Pediatrics, so I can't get the full text of the letter, but the first 20% of it is available here.

    posted by Sydney on 12/05/2005 08:43:00 AM

    Sunday, December 04, 2005

    Righting Perverse Incentives: A couple of months ago, an editorial appeared in Family Practice Management that looked at ten hard questions about the U.S. healthcare system. Questions 3-5 were especially to the point:

    3. Will Medicare, Medicaid and insurance companies, recognizing the cost savings of family medicine, reimburse cognitive services on a par with procedures?

    When hell freezes over.

    4. Since every new screening test, drug, procedure or technique trumpets its global cost-savings, why is the cost of medical care once again spiraling out of control as managed care wanes?

    Those are wink-and-a-sneer confabulations, and we all know it. Coreg vs. atenolol? TPA vs. streptokinase? Plavix vs. aspirin? Most modern drugs offer a 5 percent increase in efficacy at a 1,000 percent increase in cost, and we must remember that 86-year-old nursing home residents now receive triple-bypass surgery and hip replacements on demand.

    5. Does controlling medical inflation involve somebody making a cost-benefit decision and saying 'no' to a test, drug, procedure or technique? If so, who?

    Yes. Government, insurance companies, physicians or patients. Any volunteers?

    The editorialist goes on to argue that patients are the best people to make those cost-benefit decisions. As long time readers of this blog know, I agree with him. The editorial generated an above average number of letters to the editor, some of which take issue with his endorsement of a more consumer-driven system:

    We are not currently rationing care; we are rationing patients. Too many people have no reasonable access to medical care. This costs much more than it would cost to provide that care. Until we provide basic health care for all, we will continue to rank low in health care among industrialized countries, despite spending three times more per capita.


    Although I agree with many of Dr. Iliff's observations, I was disturbed by his reference to moral hazard as justification for change in payment mechanisms. As a family physician who has spent most of my career caring for patients in underfunded settings, I find this generalization concerning. Although there is a great deal in the actuarial and financial literature about the shortcomings of this theory when applied to health care, one of the best insights for physicians who recognize that part of our problem is that we are not created equal appeared in a recent issue of the New Yorker (see the Malcolm Gladwell New Yorker article.) [link language solely my own -ed.]

    To which Dr. Iliff gives this excellent reply:

    Every American should be covered by a high-deductible insurance policy with specified mandates, open for bidding among private companies. Whether by employer or government contributions, every family or individual would be given a yearly stipend to manage as a health savings account.

    It has taken half a century to train Americans to misuse health care resources through the perverse incentives of our present non-system. Health savings accounts would start the re-training process, as Drs. Morrell and Harover testify from personal experience. Furthermore, I have found poor people to be every bit as shrewd at managing their money as anyone else; but first, they have to have the money.

    Preach the word, brother!

    posted by Sydney on 12/04/2005 10:11:00 PM 2 comments

    At Least They're Honest: Our local public health department on the potential bird flu pandemic: Bird flu could hit. We won't be ready.
    posted by Sydney on 12/04/2005 05:38:00 PM 0 comments

    Taking Care: A doctor in Norway is under fire for mouthing off to the press:

    Doctors should discuss scientific arguments in an objective way when talking to the media, the Council for Medical Ethics of the Norwegian Medical Association ruled this week.

    The council was responding to a complaint that a professor of cardiology had claimed in a newspaper interview that government regulations requiring the first line use of thiazides for hypertension meant that doctors might risk "killing" their patients with a "rat poison drug."

    Evidently, the newspaper mixed up his comments about warfarin (also known as Coumadin, which is the stuff in D-Con) and thiazide diuretics - which, by the way, are perfectly safe, effective, and affordable drugs for the treatment of hypertension. It's easy to understand why the poor doctor is so frustrated and speaking off the cuff that way, however. In Norway, politicians evidently dictate the practice of medicine:

    The news story came after a change in drug regulations made by the Norwegian parliament in 2004, making low dosage thiazides the treatment of first choice for the management of hypertension. Doctors have to prescribe them unless they can give an explicit medical reason for making another choice.

    Do you suppose they have to petition parliament to get approval of a non-thiazide drug for their patients?
    posted by Sydney on 12/04/2005 05:25:00 PM 0 comments

    A Holiday Break: The kids and I spent most of yesterday doing holiday things - buying Christmas presents, wrapping paper, and baking cookies. We made Nestle Toll House cookies with Santa chips, though once the cookies were finished we could no longer identify Santa. His shape was there, but his face was blurred and buried in the cookie.

    We also dug out our Christmas music for the first time this year. Everyone's familiar with Nat King Cole singing The Christmas Song and Bing Crosby singing White Christmas, but how about some, ah, more unconventional Chrismtas songs?

    Phil Specter's rock-and-roll doo-wop album A Christmas Gift for You is as standard as Nat and Bing these days, but A Very Cherry Christmas has more in the way of contemporary untraditional Christmas music, such as Otis Redding's bluesy rendition of White Christmas, a Jamaican-beat version of Mary's Boy Child by Boney M., and the seductive "Make Me a Present of You" by Dinah Washington.

    For more Christmas seduction, there's Dean Martin's duet with a chorus of women, Baby, It's Cold Outside, in which Dean tries to talk them into staying inside with him against their protestations. Hear it and understand why the man who was really a down-to-earth family guy had the public image of a smooth womanizer.

    A more uncoventional duet ("Merry Christmas my arse, I think glad it's our last!"), the Pogues' Fairytale of New York is, like Specter's Christmas Album, well known these days, but how about the Irish Tenors' version? Three men singing "You were handsome, You were pretty, Queen of New York City" to each other easily makes it the gayest Christmas song ever.

    And keeping to the great tradition of family Christmas acrimony - there's the Chieftan's St. Stephen's Day Murders, a collaboration with Elvis Costello which, as near as I can tell, is about wishing your family dead. The tune's catchy, though.

    Although don't have too many drunken-family Christmas memories like those in the above songs, I do have memories of my relatives trying to out-poor each other with stories of Christmas past - "We were so poor we....Never had books....Nor crayons, neither.... Slept eight to a bed.....Had crackers and milk for Christmas dinner - and liked it!" In that fine tradition, there's Johnny Cash's Christmas As I Remember It with Cash telling of one spare Christmas in his basso profundo while a choir hums "Away in a Manger" in the background. It brought tears to my eyes the first time I heard it, until he got to the part about his father killing a squirrel for dinner. It brought up an image of a family of ten gathered around a trussed up squirrel carcass that just made me laugh out loud. Try to out-poor that, family!

    And finally, the most unconventional Christmas fare of all. Tucked into the old-timey Gospel CD collection, Goodbye, Babylon are two Christmas sermons - or "lectures" by the Reverend J.M. Gates that serve as an admonition against our distorted seasonal priorities. My favorite is "Death Might Be Your Santa Claus" recorded in 1923:

    While we think on the 25th of December, we are expecting a great day. But on that day it is said that Jesus was born, but we celebrate Christmas wrong. From the way I look at this matter, shooting fireworks, cursing, and dancing. Raising all other kind of sand, ah, but death may be your Santa Claus.

    Those of you who are speaking to the little folks and telling them that Santa Claus coming to see 'em, and the little boys telling mother and father, "Tell old Santa to bring me a little pistol," that same litttle gun may be, ah, death in that boy's hame. Death may be his Santa Claus. That little old girl is saying to mother and to father, "Tell old Santa Claus to bring me a little deck of cards that I may play five-up in the park." While the child play, death may be her Santa Claus. Those of you that has prepared to take your automobiles and now fixing up the old tires, an' getting your spares ready and overhauling your automobile, death may be your Santa Claus. You is decorating your room and getting ready for all night dance, death may be your Santa Claus. Death is on your track and gonna overtake you after while. Death may be your Santa Claus. That same revolver that that boy is toting in his pocket now may bring down somebody's son, somebody's dauagher; death may be your Santa Claus. Oh, man, oh, woman, oh, boy, oh, girl, if I were you, I would be worrying , ah, of this morning and would search deep down in my heart. (Congregation: Preach the word!) For God I live and for God I'll die.

    If I were you, I'd turn around this morning. Death may be your Santa Claus. Death been on your track ever since you was born, ever since you been in the world. Death winked at your mother three times before you was born into this sinful world. Death is gonna bring you down after while, after while; Death may be your Santa Claus

    Imagine it delivered in the sing-songy cadences of Jesse Jackson and Al Sharpton. According to the liner notes, it was his most successful sermon. Enjoy!
    posted by Sydney on 12/04/2005 01:03:00 PM 1 comments

    Friday, December 02, 2005

    The Mirror Has Two Faces: The face transplant in France is stirring controversy among plastic surgeons. Is it a matter of ethics or jealousy?

    Doctors who gave a French woman the world's first partial face transplant did not try normal reconstructive surgery first, violating the advice of a French government ethics panel, a surgeon familiar with the case said Thursday.

    Dr. Laurent Lantieri also said he was concerned the patient may not be fit psychologically for the operation and its demands.

    ....Lantieri, who developed his own plans to attempt a partial face transplant, said members of Dubernard's team contacted him last spring, seeking details of his protocol.

    According to this story, the patient lost part of her face when the family dog bit it while she was in a drug-induced stupor after a suicide attempt. It isn't clear why a history of severe depression should exclude one from a face transplant. In this video of the press conference (mostly in French, but some English), her surgeon says that her face was so badly injured that the scar tissue was keeping her from being able to open her mouth.

    While it's true that having a transplant of any kind runs the risk of tissue rejection, which would be particularly unpleasant on the face, but that's a risk that anyone who undergoes the procedure would face. Wouldn't someone with a history of depression be more likely to suffer from a terrible disfigurement than someone with a healthy psyche? Her entire face wasn't removed and replaced, just a portion of it, frome her lips to part of her nose. (See the video link to the press conference above.) The end result is here.

    As ethics go, it's hard to see why this should stir controversy. Compared to, say, embryonic stem cells or euthanasia or abortion, this seems like small potatoes. You have a patient - a consenting adult - making a treatment decision that will affect herself alone and no one else. And in this case, the treatment is being done not to disguise her identity or to answer some yearning for youth, but to repair a terribly disfiguring injury. Few of us could suffer the loss of our faces with equanimity. Considering the extent of her injuries, it doesn't at all seem inappropriate to have tried the transplant.

    P.S. For an excellent memoir of living with disfigurement, read the book Autobiography of a Face by Lucy Grealy, who, sadly, lost her struggle.

    posted by Sydney on 12/02/2005 06:48:00 PM 0 comments

    Thursday, December 01, 2005

    Vanity Fair: Are serrated suture facelifts the wave of the future?

    The barbed suture lift, nicknamed the thread lift, is a quick outpatient procedure in which doctors thread serrated plastic sutures through the fatty layer beneath the face and use them to hoist sagging tissue. The idea is to pull the skin taut, so the face looks smoother and more youthful.

    It works by providing tiny hooks on which to hang the sagging skin. Sounds painful, and for some people it is:

    But ever since the dermatologist finished Ms. Kinney's lift, the threads have been visible through her skin. They run like railroad tracks up her forehead, down her cheeks and along her neck, she said. When she washes her face, she said, the barbs feel like 'little prickles.' And, if she sleeps on the right side of her face, she wakes up with pain shooting from near her nose up to her temple.

    Medgadget had an illustration of this back in March. And here's a close-up of the little barbs (from a different brand of suture.)

    I'd be wary of having barbed sutures under the skin for any length of time. Barbs tend to be irritating, and chronic irritation in body tissues leads to scarring and sometimes tissue breakdown over time. But the threads are proving problematic even in the short term:

    But other doctors say they have seen cases in which the sutures do not hold patients' flesh taut for more than a few weeks. The tissue slides off the barbs like an ill-hung coat from a hanger. Sometimes this happens because the knotted threads in the scalp come untied or because the threads break.

    "One cough and a sneeze, and the thread lift is all over," ...

    ...A variety of strange-looking side effects have been reported. The blue Aptos sutures can show through the skin if they are placed too superficially in the fatty layer. Aptos threads also have been known to migrate.

    Dr. Nicanor G. Isse, a plastic surgeon in Burbank, Calif., said he has seen several cases in which the sutures have slid down patients' foreheads and "bunched themselves into knuckles" in the eyelids. Contour threads, for their part, can cause the skin to fold temporarily into accordion pleats, a problem that usually goes away within a couple of weeks. Both types of sutures, if improperly inserted, can be visible when patients laugh or smile, like rows of bulging veins in the face.

    Go slow on this one, even if it is promoted by Oprah and Katie. Might want to stick with Botox.


    posted by Sydney on 12/01/2005 10:56:00 PM 9 comments

    Powerful Expectations: Does pain medicine work better if promoted better by the doctor

    Your medicine really could work better if your doctor talks it up before handing over the prescription.

    Research is showing the power of expectations, that they have physical - not just psychological - effects on your health. Scientists can measure the resulting changes in the brain, from the release of natural painkilling chemicals to alterations in how neurons fire.

    Among the most provocative findings: New research suggests that once Alzheimer's disease robs someone of the ability to expect that a proven painkiller will help them, it doesn't work nearly as well.

    There was a M*A*S*H episode based on this idea. The surgeons had run out of morphine, so they gave their patients sugar pills and told them it was the most powerful pain reliever ever made. And it worked.

    I've tried to "talk up" pain medication in patients who are particularly anxious about their injuries, but not with much success. Maybe they don't trust me.
    posted by Sydney on 12/01/2005 10:32:00 PM 0 comments

    In the Mail: I received one of those annoying "physician education" packets from a pharmacy-benefits manager firm today. It's usually a mailing designed to get me to switch patients from one drug to another (preferred) drug, or to tell me that my patients would be better served with a different drug because studies say so. The patient prescription information is often six months to a year out of date, and their "research shows..." recommendations fail to take into account drug intolerances or failures in individual patients - information they don't have because they don't treat the patient or ask about it, for that matter.

    But, included in this particular mailing was a survey to evaluate the whole program. First question - "Upon receiving this information do you throw it away immediately?" YES!
    posted by Sydney on 12/01/2005 10:15:00 PM 0 comments

    New Medical Mystery: The case of the bruised old man. Here's my guess.
    posted by Sydney on 12/01/2005 10:09:00 PM 0 comments

    Medical Mystery Solution: The answer to the case of the brown-eyed, blue-eyed child is here:

    This finding is compatible with left Horner's syndrome, a regional disturbance of the sympathetic nervous system caused by the paravertebral tumor [in this case - ed.]. A unilateral lack of sympathetic stimulation in childhood interferes with melanin pigmentation of the melanocytes in the superficial stroma of the iris, resulting in heterochromia. This clinical finding might be useful in the early diagnosis of lesions affecting the sympathetic nerves.
    posted by Sydney on 12/01/2005 10:02:00 PM 0 comments

    Rashomon Medicine: One study, so many interpretations:

    In California, the Los Angeles Times says Study Defends Abortion Pill Safety:

    Government researchers investigating the deaths of four California women who contracted infections after taking RU-486 and another drug to induce abortion have found that the risk of infection from the controversial drug combination is 'low,' according to a study released today.

    The scientists also found nothing to link the deaths of the four women, who were prescribed the drugs at different clinics in Northern and Southern California between 2003 and 2005

    And the San Francisco Chronicle reports that U.S. calls abortion pill risk low despite deaths:

    Government investigators studying the deaths of four California women who took the RU-486 abortion pill played down the risks to other users Wednesday and said the fatal infection that caused the deaths wasn't particular to women taking the drug.

    In an article in the New England Journal of Medicine, the investigators described the risk of the Clostridium sordellii infection as low and said it could occur after taking the pill, undergoing a surgical abortion or giving birth.

    Their findings angered conservative opponents of the abortion pill who have been urging federal drug regulators to suspend sales as a grave threat to women's health. Liberals, who increasingly have worried that the Food and Drug Administration might buckle to political pressure and restrict access to the drug, welcomed the report.

    But in Boston, they see it differently - Article to kindle abortion pill fight :

    An article in today's New England Journal of Medicine could increase pressure on the Food and Drug Administration to restrict the sale of abortion pills associated with four fatal infections in California.

    As does Reuters -Abortion drugs linked to rare fatal infection. Others take a more neutral approach to presenting the study's results.

    The study is more accurately a post mortem investigation into the deaths of four young, healthy California women who died suddenly and unexpectedly after taking the "abortion pill" which is really two medications - mifepristone, known as RU-486, and misoprostol, also known as Cytotec. Mifepristone is the agent that causes the abortion to occur, and misoprostol acts to open up the door to the uterus to let the products of conception out. Contrary to the Los Angeles Times, the women all have many things in common. They all used the misoprostol vaginally instead of the FDA recommended oral route. (See also here - scroll down to the directions for use. Evidently, the non-approved route is not uncommon.) And they all died from the same infection - a fulminant clostridial infection. (Clostridia bacteria are known vaginal dwellers.)

    In the discussion section, the authors note that there have been an estimated 460,000 medical abortions in the United States, based on the sales figures provided by the company. There could have been fewer - there's no way to know how many of those sold pills were used. There have been 4 known deaths in women from sepsis after using it - an incidence of 0.0009%. No one knows how many women die from the same infection after childbirth, miscarriage, or surgical abortion, but the overall rate of death from infections of any type is lower in all three cases. For childbirth, it's 0.0007%, for miscarriage 0.0004%, and for surgical abortion 0.0002%.

    What's especially disturbing about the deaths is how easily the infection can be overlooked. All of the women presented with abdominal pain - an expected reaction to the abortion pill. Their physical exams were all rather benign. They had somewhat low blood pressures, but not low enough to be unusual for young women in their late teens and early twenties. They had mildly elevated heart rates - also not unusual for someone in pain or who might be anxious. None of them had a fever. The only way anyone was alerted to a problem was a striking increase in white blood cells on their blood work. This is not something that would normally be noted with their sort of presentation in any setting other than an emergency room, where blood work is done routinely on everyone. In a doctor's office, where lab work is usually only ordered if there's evidence for a need, a patient with no fever, a benign exam, and symptoms that would be expected after taking the abortion pill, this would likely be missed. It also is not clear that early intervention would have made any difference. All of these women died, even the ones who were on antibiotics and in an intensive care setting. The bacteria kills by producing a toxin, which is difficult to counteract.

    I know I would be reluctant to use a medication that killed four women in the prime of life. Especially when a safer surgical alternative is available. At the very least, I'd avoid the vaginal use of misoprostol and stick with the recommendations to use it orally.

    But casual readers of the San Francisco Chronicle and the Los Angeles Times might still think it's perfectly safe.
    posted by Sydney on 12/01/2005 08:57:00 AM 0 comments

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