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    Saturday, July 20, 2002

    Keep ‘Em Barefoot and Pregnant, For Their Own Good: Women who breast feed are less likely to have breast cancer than those who don’t, or more correctly, fewer women with breast cancer than women with breast cancer breastfed their children (71% vs. 79%). The study, published in The Lancet this past week, is one of those studies that takes a bunch of other studies and combines the results into one big megaresult. Here’s the summation:

    Women with breast cancer had, on average, fewer births than did controls (2·2 vs 2·6). Furthermore, fewer parous women with cancer than parous controls had ever breastfed (71% vs 79%), and their average lifetime duration of breastfeeding was shorter (9·8 vs 15·6 months). The relative risk of breast cancer decreased by 4·3% (95% CI 2·9-5·8; p<0·0001) for every 12 months of breastfeeding in addition to a decrease of 7·0% (5·0-9·0; p<0·0001) for each birth.

    You’ll notice that the number of births confers more of a decline in breast cancer risk than the duration of breastfeeding. You would think, therefore, that the emphasis would be given to having more children to prevent breast cancer. But that would be politically incorrect. Having too many children overburdens the earth, you know, not to mention the social welfare system. Instead, in the concluding comments, the author emphasizes the advantages of breastfeeding in cancer prevention:

    In the meantime, important reductions in breast-cancer incidence could be achieved if women considered breastfeeding each child for longer than they do now. About 470 000 women in developed countries and 320 000 women in developing countries were diagnosed with breast cancer in 1990. Based on the estimates obtained here, if women in developed countries had 2·5 children, on average, but breastfed each child for 6 months longer than they currently do, about 25 000 (5%) breast cancers would be prevented each year, and if each child were breastfed for an additional 12 months about 50 000 (11%) breast cancers might be prevented annually. There are obvious economic and social consequences to prolonging breastfeeding, and these results indicate that there are benefits to the mother, as well as the known benefits to the child.

    This paper came from England, where the National Health Service recently appointed a “breastfeeding czar” for Wales. It’s easier to get a paper published if it promotes the agenda of the prevailing healthcare system. The only problem is, this last bit of conjecture is based on the cumulative risk of breast cancer. That is, the risk of getting breast cancer by the age of 70. This cumulative risk has gone up in the last half of the twentieth century, not only because women are having fewer children and breastfeeding less over their lifetimes, but also because they are living longer. The longer a woman lives, the greater her chances of developing breast cancer, or any cancer for that matter. And the sad truth is, back in the days when women spent their child-bearing years actually bearing children, they died younger, whether they lived in the "developed world" or the "developing world". Die younger, avoid breast cancer.

    It's a stretch to suggest that women are doing society a disservice by not breastfeeding the requisite six months recommended by breastfeeding advocates. Maybe the rate of breast cancer would go down if everyone did, but we don't know that. It's all just supposition and theory. Breastfeeding remains a very intimate and personal decision. Every woman should have the right to decide for herself if and how long she wants to do it. This study has done nothing to change that.
    UPDATE: Looks like most of the world agrees.
     

    posted by Sydney on 7/20/2002 08:30:00 AM 1 comments

    Recall of Epic Proportions: Millions of pounds of ground beef processed in Colorado are being recalled because they might be contaminated with fecal matter from the cattle. If undercooked, they could cause hemorrhagic E. Coli infections. Burn those burgers.
    UPDATE: Click here for a list of the ConAgra products that have been recalled.
     
    posted by Sydney on 7/20/2002 08:29:00 AM 0 comments

    Friday, July 19, 2002

    Celebrity Medical Watch: Sharon Osbourne's colon cancer.
     

    posted by Sydney on 7/19/2002 01:11:00 PM 0 comments

    Another Argument Against Euthanasia: Dr. Harold Shipman, a physician in England who was convicted of killing his patients, started out with mercy killings:

    She added that Shipman's reasons for the killings were unclear. His first victims tended to be terminally ill, but then he moved on to murder patients that simply irritated him.

    The full inquiry is available online here.
     
    posted by Sydney on 7/19/2002 01:09:00 PM 0 comments

    Pitfalls of Relying on the Kindness of Strangers: Two blood transfusion recipients in Florida contracted HIV from infected blood that was donated before the virus was detectable in the donor.
     
    posted by Sydney on 7/19/2002 01:00:00 PM 0 comments

    Red Gold: PBS's online version of the "epic story of blood".
     
    posted by Sydney on 7/19/2002 08:38:00 AM 0 comments

    My Own Fresh Hell: Yesterday I allowed myself to be tortured. Several weeks ago, in a moment of weakness, I agreed to meet with a drug rep. I never meet with drug reps. I have embargoed them from my practice for the past three years. But, this guy showed up last month and made my receptionist feel sorry for him. His supervisor was with him. The supervisor didn’t believe him when he said I wouldn’t meet with drug reps. She thought it looked like he was in trouble with his boss. He was a nice guy. He had two small children. I agreed to a future meeting out of pity, and because I didn’t want my receptionist to think I was hard-hearted. I think I was conned.

    At least, that’s what I found myself thinking as I sat there giving up more and more of my precious lunch break to his sales pitch. Not that I listened very carefully to his pitch. Instead, I thought about the enormous funds devoted to marketing by drug companies. I thought about copycat drugs, like Nexium, the drug he was selling. I thought about the legal gymnastics his company had performed to block the generic version of Prilosec from coming to the market, so they could gain time to grab more market share for the more expensive mirror-image version of it that is Nexium. I thought of how proud they are of their Nexium sales, and its market share, ($580 million dollars in 2001, and 16% of new prescriptions.) I thought of their ubiquitous ads, and of how much they must have cost. The longer I sat there, the more he seemed to personify all that is wretched in the pharmaceutical industry.

    Then, he did something that caught my attention. Suddenly his pitch became much more personal. He produced a reprint of a study comparing Nexium to Prevacid, the drug in this class which I prefer to prescribe. He mentioned that about forty percent of my patients have a health insurance plan that uses the dreaded Merck-Medco for pharmacy benefits. I have never shared any of this information with him or any other drug rep. I doubt very much if any of my staff ever has, either. It could only mean that he had resorted to the Big Brother technology available to pharmaceutical companies to profile my prescribing habits and my patient mix. It was chilling, and it was maddening.

    Finally he delivered what he thought was the coup de grace. He told me my patients were spending more on co-pays for Prevacid than they would for Nexium, for although Nexium costs around $120 a month out of pocket, it is the preferred drug for Merck-Medco because it “has met their high quality standards.” Right. I guess he thought I didn’t know that Merck profits from sales of Nexium, as well as from its twin, Prilosec.

    A person can only take so much. I dropped all pretense of politeness and told him exactly what I thought of Nexium and of his company. Needless to say, I didn’t get a free pen.

    Call for Reform: I probably could have maintained my polite demeanor if I hadn’t just read the Families USA report on pharmaceutical industry spending that morning. (The report is available on their site, but it’s in pdf format.) Not only does it make note of the disproportionate amount of money spent on promotion by the industry, it also points out that research and development are not high on their list of priorities by any measure:

    Beyond spending patterns, staff allocation reflects an organization’s focus. Staffing patterns reported by some of the companies in this study confirm the industry’s focus on marketing over research and development. In 2001, Merck added 1,000 sales representatives to its U.S. operations alone. Of the company’s 78,100 employees, 85 percent were engaged in non-research activities. Allergan reported that it had 1,700 employees in sales representative positions, which represents only a portion of all employees engaged in marketing-related activities. In comparison, 1,100 people were involved in the company’s research and development efforts. These staffing patterns are consistent across the industry. A report released in December 2001 found that brand-name drug makers in the U.S. employ 81 percent more people in marketing than in research. This study also found that marketing staffs increased by 59 percent between 1995 and 2000, while research staffs declined by 2 percent.

    I don’t begrudge a company its profits, or a CEO his just salary, but any industry that invests more in promotion than in innovation is ultimately doomed. Would Bayer have lasted as long as it has if they had relied solely on aspirin? The board members and the CEO’s of these companies need to examine their current policies and reform their spending habits. Otherwise, they’ll be left with nothing as their patents expire one by one, as they eventually must, despite their best efforts.

    Bedfellows: Opensecrets.org has more on the generic drug bill and the Pfizer/Pharmacia merger.
     
    posted by Sydney on 7/19/2002 06:11:00 AM 0 comments

    Those Resourceful Special Forces: The New England Journal of Medicine had a letter to the editor (requires paid registration) this week from a Pentagon physician who discovered that the members of the Special Forces possess special intelligence about antibiotic availability:

    To the Editor: I recently treated an Army Special Forces soldier who presented with a three-month history of purulent sinusitis that was not responding to self-medication. After much prodding, he related that he had been taking a combination of penicillin and sulfa antibiotics, which he had purchased without a prescription "in the fish medication aisle" of a local pet store. He went on to explain that this over-the-counter source of antibiotics is common knowledge among all branches of the American Special Forces community.

    Never underestimate the ingenuity of the American Special Forces
     
    posted by Sydney on 7/19/2002 06:10:00 AM 0 comments

    Glad I’m Not the Only One: I’ve often wondered about the paucity of HIV positive patients in my own practice. In eleven years of practice I can count my HIV positive patients on one finger. Maybe I live in a community with an exceptionally low infection rate. Maybe I don’t test my patients for it enough. Maybe it isn’t an epidemic after all.
     
    posted by Sydney on 7/19/2002 06:09:00 AM 0 comments

    Thursday, July 18, 2002

    That Was Quick: DB's Medical Rants says that lawyers have already filed a class-action suit against the makers of Prempro, the drug involved in last week's highly-publicized hormone replacement study. Once again, media hysteria trumps science.
     

    posted by Sydney on 7/18/2002 08:36:00 AM 0 comments

    Food of the Gods: In honor of the recent discovery of 2,600 year old traces of chocolate in a jug, here is a link to the medicinal history of chocolate. It seems as if those Europeans ingested as medicine just about everything they found in the New World: tobacco, coffee, chocolate. There is, however, some justification for all of these being used medically, although our forefathers couldn’t have known it. Nicotine, caffeine, and theobromine (the medically active ingredient in chocolate) all resemble theophylline(scroll down past the caffeine image), a drug used for asthma.

    (Note: I make no claims for that tofu-chocolate pie recipe in the medical chocolate link. Haven't tried it. Never will. I like my chocolate unadulterated by health foods.)
     
    posted by Sydney on 7/18/2002 08:16:00 AM 0 comments

    Giving Jeeves a Run for His Money: Would Bertie Wooster ever have hired Jeeves if he had had this?
     
    posted by Sydney on 7/18/2002 07:50:00 AM 0 comments

    West Nile Virus: There appears to be a minor outbreak of West Nile virus in Louisiana. The mosquito-borne virus can be deadly, but it’s important to keep its contagiousness in perspective. Less than 1% of mosquitoes in virus-infested areas carry the virus. Among people who become infected by those mosquitoes, less than 1% develop a serious illness. Of those who develop a serious illness, only 3% to 15% die. Most of the time, it just causes a flu-like illness of very little consequence. Still, it’s a good idea to wear mosquito repellant. (For more information about West Nile virus, click here.)
     
    posted by Sydney on 7/18/2002 07:46:00 AM 0 comments

    Breast Cancer: Patients with breast cancer that is sensitive to estrogen and that has not spread to the lymph nodes don’t need chemotherapy. Tamoxifen alone will do:

    Researchers further divided the 1,669 patients in the study into groups based on whether their cancers were sensitive or not sensitive to estrogen, a hormone that can promote the growth of breast cancer cells.

    There were 382 in the study whose tumors were not sensitive to estrogen, described in medical terms as being estrogen receptor negative, or ER-negative. There were 1,217 who were ER-positive. For the remaining 70 patients, the ER status was unknown.

    About half in each of these groups were treated with chemotherapy followed by five years of tamoxifen. The other half of each group received tamoxifen only.

    Researchers followed the patients for an average of almost six years and found that the value of chemotherapy depended directly on the estrogen sensitivity of the patients' disease.

    Among the ER-positive patients, chemotherapy provided no benefit. The five-year, disease-free survival for those who took only tamoxifen was 85 percent, while it was 84 percent for those who had both chemo and tamoxifen.

    However, for the ER-negative patients, chemotherapy could be a life-saver. The five-year, disease-free survival for those who had both chemo and tamoxifen was 84 percent. But for ER-negative patients who took only tamoxifen, the survival rate was only 69 percent, a 15 percentage point difference.


    That’s good news. Chemotherapy can be especially noxious and often has to be given intravenously. Tamoxifen, on the other hand, has minimal side effects and is just one pill a day.
     
    posted by Sydney on 7/18/2002 07:39:00 AM 0 comments

    Carmona Update: The nomination of Dr. Carmona for surgeon general has passed the committee stage and is now up to the Senate.
     
    posted by Sydney on 7/18/2002 07:35:00 AM 0 comments

    Self-Regulation Some readers think I’m being too hard on the medical device industry when I criticize their efforts to win the right to police themselves. They point out that the current system is very slow because there aren’t enough FDA inspectors and that self-policing works well in other industries. The medical device industry, however, is not like other industries. Their products are put into our bodies (artificial joints, artificial heart valves, stents, etc.) The consumer (i.e. patient) has no choice as to which product goes into his body. He trusts the physicians who in turn trust the companies to provide a safe product. Companies are in business to make a profit, not to benefit humanity. When profit, not service, is the prime motivation, the pressure to maximize the bottom line pervades the entire corporate culture. This is equally true of the firms that would be hired to do the inspecting. The temptation to avoid conflict and give favorable judgements to the companies that hire them to do the inspections would just be too great. Even small problems that were overlooked for this reason could have ultimately fatal consequences. If there’s a problem with the speed of inspections now, then a better solution would be to increase the budget of the FDA so they could hire more inspectors, not to turn inspections and standards over to the industry.
     
    posted by Sydney on 7/18/2002 07:29:00 AM 0 comments

    Wednesday, July 17, 2002

    Smallpox Suppositions: Fairhaven, the River, has some info on the decision process the CDC used to come up with the "ring-vaccination" strategy to combat smallpox bioterror. All I can say is, thank goodness the White House has other advisers on the case.
     

    posted by Sydney on 7/17/2002 10:17:00 AM 0 comments

    Yet Another Estrogen Study: I wasn’t going to comment on this until tomorrow, but I heard it covered on NPR this morning on my way to the hospital, and I couldn’t let it pass. In addition to the much-hyped estrogen replacement study, JAMA also has a study on the link between estrogen and ovarian cancer in this week's issue. The study claims that there is a significant risk of developing ovarian cancer in women who take estrogen alone:

    Lacey’s research involved 44,241 post-menopausal women whose health histories were tracked for about 20 years as part of a major breast cancer study. Among those women, 329 developed ovarian cancer. The researchers found that compared to similar women not on hormones, those taking estrogen therapy had a 60 percent greater risk of developing ovarian cancer.

           The risk increased proportionately with longer duration of hormone use; those who used estrogen therapy for 20 or more years were approximately three times more likely to develop ovarian cancer. However, women who used an estrogen-progestin combination did not appear to have a significantly increased risk of ovarian cancer.
           “The main finding of our study was that post-menopausal women who used estrogen replacement therapy for 10 or more years were at significantly higher risk of developing ovarian cancer than women who never used hormone replacement therapy,” Lacey said in a statement released by the cancer institute.


    Saying that women on estrogen are 60% more likely to develop ovarian cancer may be a statistically true statement, but it leads one to believe that the risks are greater than they are. Most people reading that statement would think that 60 out of 100 women who take estrogen develop ovarian cancer. Nothing could be further from the truth.

    Unfortunately, the original paper is as clear as mud when it comes to assessing individual risks. The study tracked the medical histories of 44,241 postmenopausal women for anywhere from one month to 20 years. (The mean follow-up was 13 years.) Nowhere in the paper do the authors tell us how many of those were taking estrogen, and how many weren’t. They identified 329 cases of ovarian cancer, but they don’t tell us how many of those were taking estrogen or for how many years they took it before diagnosis. Instead, they express their data in terms of “person-years” and “rate ratios”. The highest rate ratio of ovarian cancer that they came up with for estrogen users was 1.6. This is where the figure of “60% more likely to develop ovarian cancer” came from. The non-users of estrogen were given the value of 1.0 for their rate ratio, since that is the standard to which the users of estrogen were being compared. What does this all mean? Who knows? The paper is written in such a haze of statistical analysis that it’s impossible for a non-mathematician to cut through it. (Looks like a case for Numberwatch)

    What I do know, is that the numbers of ovarian cancers detected were very small in proportion to the number of women followed. That, combined with all the stastitical mumbo jumbo in the paper, makes me doubt the clinical significance of the findings. Even the accompanying editorial in JAMA admits that the data “do not establish causality.” This is one report that should be taken with a very large grain of salt.
     
    posted by Sydney on 7/17/2002 09:37:00 AM 0 comments

    JAMA's weekly art history lesson.
     
    posted by Sydney on 7/17/2002 06:02:00 AM 0 comments

    Drill 'Em, Fill 'Em, Bill 'Em: All you've ever wanted to know about dental fillings, and then some.
     
    posted by Sydney on 7/17/2002 06:02:00 AM 0 comments

    Botox Bash: A John's Hopkins professor of facial and plastic surgery had to cancel his Botox party. He had invited the entire John's Hopkins community to it: faculty, employees, and students. The university's administration felt such an event was "beneath the dignity" of the institution.
     
    posted by Sydney on 7/17/2002 06:00:00 AM 0 comments

    Clever Acronym Watch: Enzyme Linked Virus Inducible System or ELVIS for short. (It's a test for herpes of the eye)
     
    posted by Sydney on 7/17/2002 05:59:00 AM 0 comments

    The Twins Take on HRT: Time and Newsweek both made estrogen their cover story. (Do you ever wonder if their editors are related to one another? Their covers are the same so often.) Of the two, Time does the better job of presenting the facts. They don’t veer off into wild speculation and data manipulation the way Newsweek does. Take this little tidbit from Newsweek for example:

    Unfortunately, even a small risk to individuals can have big consequences when applied to a large population. The study suggests that, on balance, a group of 10,000 long-term Prempro users would suffer 31 excess health crises each year (strokes, heart attacks, blood clots, breast cancers), while avoiding only 11 bone fractures and colon cancers. That’s a net increase of 20. If 100,000 people take up long-term HRT, they’ll suffer 200 of these needless events each year. A million long-term Prempro users will experience 2,000 of them annually—which means 20,000 over the course of a decade. This is no way to prevent hip fractures.

    In treating menopause, we are treating individuals, not society. Every drug has potential risks and side effects. If we did away with all drugs that could cause 20,000 “needless events” over a ten year time period when taken by one million people, we wouldn’t treat anything with long term medication.

    Newsweek also speculates on the best way to stop the medication. Should women just stop it cold turkey, or wean themselves off? "Studies will soon tell us", they say. Goodness. You would think that every woman who has ever taken estrogen in the past forty years had never stopped it before. Plenty of people have stopped taking it before. You don't have to "wean it off", you can just stop it. The method of stopping it won't make any difference in the hot flashes. Once the hormone is stopped, the hot flashes return. (For some women, but not for all.) Not everything has to be studied scientifically, sometimes experience counts.
     
    posted by Sydney on 7/17/2002 05:49:00 AM 0 comments

    Analyze This: According to this review of Jerome Kagan's critique of psychiatry, Surprise, Uncertainty and Mental Structures, the Harvard psychologist gives the field an "F". Mostly, he says, both psychologists and psychiatrists fail to appreciate the subtle nuances of the human mind:

    The central element in the diagnosis of depressive disorder, for example, includes reports of sadness, apathy, sleeplessness and poor appetite. This, says Kagan, is far too general, and rather like assuming that all stomach aches have the same cause.

    If depression is the result of failure to meet some moral standard, then it should be called a guilt reaction. If the same symptoms occur in an adolescent worried about his future, because his family is poor, "his condition is better described as a state of hopelessness". A third depressive may have inherited a neurochemical imbalance. "These three patients should be placed in different diagnostic categories."


    So true. It’s just too easy these days to load everyone up with Prozac.
     
    posted by Sydney on 7/17/2002 05:43:00 AM 0 comments

    Tuesday, July 16, 2002

    Every Cloud Has a Silver Lining: Lackluster Marriage Enlivened By Cancer Scare
     

    posted by Sydney on 7/16/2002 06:16:00 AM 0 comments

    Whose Choice Is It? Lee Bockhorn, at The Weekly Standard has a good dissection of this New York Times Sunday Magazine Essay on the abortion choice of a minor. I thought much the same thing when I read the essay a couple of weeks ago. The parents seemed to have bullied their daughter into the abortion against her obvious wishes. It’s true that she’s a minor, but it seems they could have come up with something other than abortion as the choice (like adoption) if she was so opposed to it. Now, the abortion can be chalked up as one more emotionally traumatic experience in the young girl’s life, along with watching her friend die at the age of four:

    I know what's inside my daughter. When she was 4, her best friend died of cancer. Other parents wouldn't let their children play with the dying girl, but my daughter held her friend's hand right up to the end.

    Maybe that’s why this daughter is so troubled in the first place. There’s certainly nothing wrong with allowing a child to play with another terminally ill child, but it was probably going too far to have her at the death bed at the age of four. She’s still dealing with that trauma, how much longer will it take her to live down her latest parent-inflicted trauma?
     
    posted by Sydney on 7/16/2002 06:14:00 AM 0 comments

    Celebrity Medical News: The articulate Elizabeth Cohen at CNN expounds on whole body scans. The impetus to her story is that two baseball celebrities, Atlanta Braves announcer Skip Caray and Hall of Fame pitcher Don Sutton, found life-threatening conditions by having scans. In the end, she gives good advice, in her own idiosyncratic way:

    It doesn't find everything, and that is really important for people to keep in mind. Because when you see these pictures, you think, gosh, they have looked into every nook and cranny of my body, what could it have missed?

    Well, you know what, it is not going to find high blood pressure. It is not going to find high cholesterol levels; it is not going to find infection; it is not going to find an abnormal heart rhythm, which sometimes is the reason why people have heart attacks. You need to go to your doctor for that. So the scan does not find everything.

     
    posted by Sydney on 7/16/2002 05:59:00 AM 0 comments

    Thinking with the Heart: The NY Times has a scary article on sudden death in children. (Link requires registration.) Reading it leaves you cold and anxious if you have children. It’s a silent condition that no one screens for because the test is “too expensive.” As a result, children are dying from it all over the place. Or at least, that’s the impression the article gives. The last line is a quote from a woman whose son died of the disease while playing football: "Prevention, is 10 times better than hopeless resuscitation."

    The condition in question is idiopathic hypertrophic cardiomyopathy, a thickening of the muscles in the heart that can lead to obstruction of blood flow and sudden death. The problem is, those two outcomes aren’t preordained. Some people with the condition never have any problems at all. There’s no way to predict who will die and who will live. As this Mayo Clinic guide to treatment makes clear:

    Reports involving large numbers of patients from tertiary referral centers suggested that HCM [hypertrophic cardiomyopathy] was a malignant disease characterized by early sudden cardiac death. Subsequent population-based studies have shown that life expectancy is normal in HCM as a whole; however, there are clearly HCM families that harbor a malignant tendency for sudden death. The identification of individuals (and families) who are at higher risk for SCD [sudden cardiac death] is difficult. (emphasis mine)

    Current practice is to screen children for the condition if they have symptoms or have a family history of early unexpected cardiac death. It would be impossible to screen every child for the disorder. Doing so could even lead to more harm than good, since it could lead them down the road to treatment that they may not even need.

    We have an imperfect knowledge of many things in life. This is one of them. We just aren’t at the stage in our learning curve of this condition where it would be wise to test everyone for it. Someday we will be, perhaps when genetic testing makes it possible to identify those most at risk, but that day is not today.
     
    posted by Sydney on 7/16/2002 05:52:00 AM 0 comments

    Screen Everyone for Everything: The American Heart Association has come out with new screening guidelines for heart disease.

    "Heart disease can be prevented, and we have to start at a young age to do it," says panel member Sidney Smith [not me], professor of medicine at the University of North Carolina-Chapel Hill.

    The guidelines recommend:
    * Weight loss for those with a body mass index over 25 or waist measurement over 40 inches for men and 35 inches for women.
    * Moderate physical exercise 30 minutes per day, preferably every day.
    * Low-dose aspirin for patients with a 10% risk of developing heart disease within 10 years.
    * No exposure to tobacco smoke, including secondhand smoke.
    * Control of blood pressure and blood fats.
    * Regular pulse checks and treatment for atrial fibrillation, an irregular heartbeat associated with blood clot formation, which could lead to stroke.


    All of this seems benign and reasonable, but it will mean that more people will be on cholesterol lowering drugs for most of their lives. Start someone on a drug to lower cholesterol at 20, and there's a good chance he'll still be taking it by age 80. That's sixty years of daily drug exposure. Those drugs haven't been around that long. We don't know what kind of long term effects they may have on the body. We also don’t know how effective this approach will be at reducing heart disease. The panel is just assuming it will be worth the risks. It’s a recommendation based on the same sort of science that hormone replacement therapy was twenty or thirty years ago. A little bit of data and whole lot of supposition.
     
    posted by Sydney on 7/16/2002 05:48:00 AM 0 comments

    A Case in Point: Derek Lowe, who works in the drug industry, has some thoughts on why Merck-Medco counted pharmacy co-pays as part of their revenues. (HINT: Executive bonuses were tied to revenue numbers.)
    UPDATE: If you scroll up on his page he has more on this, and on the Pfizer-Pharmacia merger.
     
    posted by Sydney on 7/16/2002 05:41:00 AM 0 comments

    Slow Learners: As if to prove they've learned nothing from the recent business scandals, Congress is debating whether or not to let medical device companies choose their own inspectors and third-party reviewers, rather than having the FDA police them. The bill is part of an attempt to get the companies to pay the FDA user fees, like drug companies do now. Self-regulation is the suggestion of the companies in response to those user fees. They want something back for their money, and that something is a system in which they only have to answer to themselves. That Congress and the FDA is even considering allowing companies to do this in the wake of the recent Enron and Worldcom scandals is amazing. They apparently haven’t learned anything about the ethics of the business world, or as one consumer advocate put it, “they don’t know a conflict-of-interest when it hits them on the head”:

    Some consumer and patient groups who follow the issue say they are alarmed by the proposals, which they say could weaken safety precautions. According to Diana Zuckerman, president of the National Center for Policy Research for Women & Families, the willingness of the FDA to entertain the proposal shows "they don't know a conflict-of-interest when it hits them on the head."

    "These review and inspection companies know that they have to do a certain kind of job to be selected again," she said. "If they reject an application or find problems during an inspection, it's unlikely they'll get chosen the next time, so they have real incentive to overlook a company's problems."


    We depend on the FDA to protect us from corporate malfeascence in the drug industry. Unfortunately, the FDA is underfunded and not up to the task. Their appropriations committee is the same one that doles out agricultural subsidies, so they get slighted. Too bad our Congressmen can’t break themselves of their pork habits enough to distribute our tax dollars responsibly.
     
    posted by Sydney on 7/16/2002 05:30:00 AM 0 comments

    Monday, July 15, 2002

    Full Circle: When it was first introduced to Europe, tobacco was used almost exclusively as a medication. Apothecaries sold it as a tincture of boiled tobacco leaves called herba sancta Indorum. Now, tobacco leaves are again playing a medicinal role - this time in cancer research. The tobacco has been genetically engineered to grow pieces of human lymphoma.

    Hey, wasn’t there an X - File like this?
     

    posted by Sydney on 7/15/2002 07:41:00 AM 0 comments

    Breathing Easier: The history of intubation
     
    posted by Sydney on 7/15/2002 07:29:00 AM 0 comments

    Scrutinizing Surgery: A recent study in the Archives of Surgery opines that appendectomies are over-performed. The LA Times interprets this to mean they are often misdiagnosed.

    Technically, I suppose that’s true, if the appendix isn’t inflamed at the time of surgery, then it wasn’t appendicitis. But, using the term “misdiagnosed” implies that a mistake was made on the part of the surgeon, which isn’t necessarily so. Medical diagnosis is akin to solving a mystery. The doctor has to sort through the signs and symptoms and make a best guess as to their source. Sometimes, it’s easy to confirm, sometimes it isn’t. Pneumonia, for example, can be confirmed easily with a chest x-ray. There is no easy confirmation test for appendicitis, short of surgery. To make it more difficult, complications, including death, go up dramatically in appendicitis that has gone untreated for twenty four hours. Surgeons don’t have the luxury of waiting and observing to “see how things go” before operating.

    The study in question says that an estimated $741.5 million dollars are spent on people who were thought to have appendicitis and didn’t. What the study doesn’t tell us is how many lives are saved by our current approach to appendicitis. Perfection in this case is impossible. As one doctor interviewed for the story pointed out:

    Williams also suggested that it's unrealistic and risky to strive for eliminating surgeries on normal appendixes. Doing so would mean subjecting all patients with appendicitis-like symptoms to longer observation times and hospital stays, and could mean more ruptured appendixes and even deaths, Williams said.
     
    posted by Sydney on 7/15/2002 07:28:00 AM 0 comments

    Malpractice Crisis Update: The Las Vegas trauma center was able to reopen, at least for 45 days. They recruited orthopedists practicing in the community to cover for the doctors who quit. However, the new doctors will only be there for 45 days, the period of time that they will be covered by a $50,000 liability cap. After that, the crisis starts all over again. Unless the legislature is somehow able to get tort reform through in those few days.
     
    posted by Sydney on 7/15/2002 07:27:00 AM 0 comments

    Real AIDS News: Researchers have discovered a gene that bolsters the body's defense against HIV. Hmm. This could partially explain why rates of infection are higher in some ethnic groups than others.
     
    posted by Sydney on 7/15/2002 07:26:00 AM 0 comments

    Final Analysis: A critique of the AIDS conference.
     
    posted by Sydney on 7/15/2002 07:25:00 AM 0 comments

    Faulty Data: Martin Roth (scroll down to July 13) has more on AIDS in Africa, including a link to this story from the November 2001 issue of Rolling Stone that casts doubt on the number of AIDS cases in Africa. The author set out to write an article blasting the South African government for doing too little. He came away with data that made him rethink the whole thing. It’s an eye opener. To begin with, the UN estimates for AIDS infection numbers are based on statistical manipulations:

    .. According UNAIDS, "anonymous blood specimens left over from these tests [routine prenatal care tests] are tested for antibodies to HIV," a ritual that usually takes place once a year. The results are fed into a computer model that uses "simple back-calculation procedures" and knowledge of "the well-known natural course of HIV infection" to produce statistics for the continent In other words, AIDS researchers descend on selected clinics, remove the leftover blood samples and screen them for traces of HIV The results are forwarded to Geneva and fed into a computer program called Epi-model: If a given number of pregnant women are HIV-positive, the formula says, then a certain percentage of all adults and children are presumed to be infected, too. And if that many people are infected, it follows that a percentage of them must have died. Hence, when UNAIDS announces 14 million Africans have succumbed to AIDS, it does not mean 14 million infected bodies have been counted. It means that 14 million people have theoretically died, some of them unseen in Africa's swamps, shantytowns and vast swaths of terra incognita.

    Most of Africa is too disorganized to reliably track death rates and compare the actual numbers to the UNAIDS estimates, but South Africa, where the author lives, does track death rates:

    It therefore seemed to me that checking the number of registered deaths in South Africa was the surest way of assessing the statistics from Geneva, so I dug out the figures. Geneva's computer models suggested that AIDS deaths here had tripled in three years, surging from 80,000-odd in 1996 to 250,000 in 1999. But no such rise was discernable in total registered deaths, which went from 294,703 to 343,535 within roughly the same period. The discrepancy was so large that I wrote to make absolutely sure I had understood these numbers correctly..... Between these extremes lay a gray area populated by local experts such as Stephen Kramer, manager of insurance giant Metropolitan's AIDS Research Unit, whose own computer model shows AIDS deaths at about one-third Geneva's estimates.

    In addition to confounding the issue with statistical voodoo, the AIDS numbers also may be inflated due to the testing methods themselves. Instead of confirming a postive ELISA test with the Western blot testing , the AIDS numbers are based on only one ELISA test. This test is not a specific test for AIDS, it’s a test for antibodies to AIDS, and it can be confounded by antibodies to other diseases, say malaria or tuberculosis, both of which are also running rampant in Africa:

    It seemed something was confounding the tests, and the prime suspect was plasmodium falciparum, one of the parasites that causes malaria: Of the twenty-one subjects who tested positive, sixteen had had recent malaria infections and huge levels of antibody in their veins. The researchers tried an experiment: They formulated a preparation that absorbed the malaria antibodies, treated the blood samples with it, then retested them. Eighty percent of the suspected HIV infections vanished.

    ....Back in 1994, Max Essex, head of the Harvard AIDS Institute, and some collegues of his observed a "very high" (sixty-three percent) rate of ELISA false positives among lepers in central Africa. Mystified, they probed deeper and pinpointed the cause: two cross-reacting antigens, one of which, lipoarabinomannan, or LAM, also occurs in the organism that causes TB. This prompted Essex and his collaborators to warn that ELISA results should be "interpreted with caution" in areas where HIV and TB were co-endemic. Indeed, they speculated that existing antibody tests "may not be sufficient for HIV diagnosis" in settings where TB and related diseases are commonplace.

    Essex was not alone in warning us that antibody tests can be confused by diseases and conditions having nothing to do with HIV and AIDS. An article in the Journal of the American Medical Association in 1996 said that "false-positive results can be caused by nonspecific reactions in persons with immunologic disturbances (e.g., systemic lupus erythematosus or rheumatiod arthritis), multiple transfusions or recent influenza or rabies vaccination.... To prevent the serious consequensces of a false-positive diagnosis of HIV infection, confirmation of positive ELISA results is necessary.... In practice, false-positive diagnoses can result form contaminated or mislabeled specimens, cross-reacting antibodies, failure to perform confirmatory tests.... or misunderstanding of reported results by clinicians or patients." These are not the only factors that can cause false positives. How about pregnancy? The U.S. National Institutes of Health states that multiple pregnancy can confuse HIV tests. In the past few years, similar claims have been made for measles, dengue fever, Ebola, Marburg and malaria (again).


    The author talked to a UNAIDS advisor who naively told him that countries with high false postives would report it to the agency. The author thinks otherwise:

    High AIDS numbers are not entirely undesirable in poverty-stricken African countries. High numbers mean deepening crisis, and crisis typically generates cash. The results are now manifest: planeloads of safari scientists flying in to oversee research projects or cutting-edge interventions, and bringing with them huge inflows of foreign currency - about $1 billion a year in AIDS-related funding, and most of it destined for the countries with the highest numbers of infected citizens.

    On the ground, these dollars translate into patronage for politicians and good jobs for their struggling constituents. In Uganda, an AIDS counselor earns twenty times more than a schoolteacher. In Tanzania. AIDS doctors can increase their income just by saving the hard-currency per diums they earn while attending international conferences. Here in South Africa, entrepreneurs are piling into the AIDS business at an astonishing rate, setting up consultancies, selling herbal immune boosters and vitamin supplements, devising new insurance products, distributing condoms, staging benefits, forming theater troupes that take the AIDS prevention message into schools. A friend of mine is co-producing a slew of TV documentaries about AIDS, all for foreign markets. Another friend has got his fingers crossed, since his agency is on the shortlist to land a $6 million safe-sex ad campaign.


    An AIDS counselor earns twenty times more than a schoolteacher? Could this be true? The damage that can be done by politicizing a disease never ceases to amaze. At least one South African AIDS activist knows what needs to be done to help stem the African problem:

    "There's a place for AIDS drugs and prevention campaigns," he says, "but it's not the only answer. We need to roll out clean water and proper sanitation. Do something about nutrition. Put in some basic health infrastructure. Develop effective drugs for malaria and TB and get them to everyone who needs them."

    But will the AIDS activists listen?
     
    posted by Sydney on 7/15/2002 07:20:00 AM 0 comments

    Sunday, July 14, 2002

    The Bane of Summer: Some good advice on mosquito bites. The same advice holds true for treating the itch of poison ivy.
     

    posted by Sydney on 7/14/2002 08:34:00 AM 0 comments

    Alternative Medicine Watch: Enterprising street vendors were selling cures for AIDS in India. Let's just say they used parts of the Hindu sacred animal that no one would want.
     
    posted by Sydney on 7/14/2002 08:27:00 AM 0 comments

    Abstinence Helps: Zambia has had some success in decreasing the rate of AIDS transmission in young women by emphasizing the importance of abstinence:

    In the last five years, the percentage of HIV-infected girls aged 15 to 19 decreased from 28 percent to 15 percent. Zambia and Uganda are the only countries in sub-Saharan Africa to see a measurable decrease in new infection rates.

    The reason the rates have gone down:

    A survey of youth aged 13 to 19 found that many decided to remain abstinent directly due to television and radio advertisements produced by young people.

    The TV advertisements showed teen-age girls singing about the benefits of setting goals in education and holding onto the power of choosing whether to have sex. Some ads promoted condom use. The ads ran from 1998 to 2000, but were taken off the air because of controversy over one segment that showed girls telling their boyfriends, ''No condom, no sex.''

    Only last week, after 20 months without the prevention ads, the government allowed them back on the air - but only after signing off on the content.


    Yes, the ads did mention condoms as well as abstinence, but it’s noteworthy that the teens surveyed said they chose abstinence based on the ads. It’s always frustrating to hear people dismiss the idea of promoting abstinence as if it has no value at all, like this activist from Brazil:

    ''Millions and millions of young people are having sexual relations,'' said Paolo Teizeira, director of Brazil's AIDS program. ''We cannot talk about abstinence. It's not real. This is a big and very risky initiative.''

    He seems to think that we are like animals, with no ability to control our impulses. The truth is that if presented in the right way, the message of abstinence can get through, and the advantages it provides far exceed the reduction of sexually transmitted diseases. As an added bonus, you get fewer teenage pregnancies, fewer single mothers, fewer families dependent on government aid, and more young women who pursue higher education. Promoting abstinence sends the message to young women that they don’t have to rely on their sexuality for self-esteem. It’s a win-win approach for society and for women. Why would anyone be opposed to that?
     
    posted by Sydney on 7/14/2002 08:19:00 AM 0 comments

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