An Inside View: A practicing radiologist with 20 years experience in reading mammograms sent along these comments about the disparity between the expectations and the reality of the technology, and its implications for litigation:
As a radiologist who still practices mammography, I know it is heresy to go against the American College of Radiology's recommendations and PR concerning mammography. But as a cycnical individual and a critical physician, I think any physician or individual with common sense who actually took the time to see the dilemma radiologists are in when reading mammograms would think we are absolutely crazy for still doing it. And more and more radiologists are opting not to, and very shortly, I may make that decision myself.
I've been doing this now for almost 20 years since I began residency in 1983, and the expectations both from the professional side as well as the side of the patient are completely unreasonable. This is the only diagnostic modality where the positive findings we are expected to see, get smaller and more subtle as the years go on. The detection of microcalcifications is getting to the point where we are going to require microscopes to see the things we are being held responsible for. Even the computer aided detection systems out on the market miss many of these things.
Our own published literature states that in women who have had annual yearly mammograms, and develop an interval breast cancer, that in up to 70% of the cases there will be some evidence of the cancer on the prior mammogram if you know where to look and exactly what to look for. Does this mean that we are all terrible at what we do? More likely, it's a problem with the modality expecting more from human perception than is reasonable. If you ask the NY Times however, they will tell you that the problem solely lies with the radiologist. In towns like Cleveland, in the midst of a litigation crisis, which by the way is where I used to work( for 15 years, another story) the lawyers know this. There are ads on the TV, that tell women who have had breast cancer detected on mammograms, that it is likely they are owed money and to bring their mammograms in to the lawyer's office for their own experts to review. The mammography litigation has skyrocketed.
I believe as you alluded to that there is a problem not only with the radiology leadership on this issue letting its own people down, but I believe there is actually a somewhat more subtle, and sinister aspect. The people who provide guidance and determine the policy of the ACR on mammography stand to benefit tremendously financially. As recognized experts, they spend time writing books, which they sell, lecture all over the world for lots of money and travel time, and then make a lot of money as expert witnesses against the radiologists they teach, because they always have the power of hindsight behind them. I know this sounds very conspiratorial, and I'm really not that kind of individual, but in my own experience this seems to be true.
As far as the patients are concerned, with mammography, sometimes we win and sometimes we lose. So, as this is presently the only available modality to find early breast cancer, it still has value. But it's extremely far from perfect as are the individuals stuck interpreting them.
And you are absolutely right about ultrasound, this is even a worse trap as far as the false positive and false negative situation. One of our national experts, who does a great deal of defense work on the part of radiologists, has been quoted as saying, if you don't think there's anything there on the ultrasound, take no images and leave no record, because virtually anything on an ultrasound image can be construed as being potentially positive under the right circumstance.
ADDENDUM: To get an idea of what radiologists are up against in interpreting mammograms, click here and scroll down to the third item. The image on the right is a mammogram of a dense breast. The one on the left is a normal breast. And here's an ultrasound image. It's easy to see why interpreting them isn't a perfect science.
Tylenol Tumult: The FDA is considering requiring stronger warnings about side effects on over-the-counter acetaminophen bottles. Acetaminophen is the active ingredient in Tylenol and most other non-aspirin pain relievers found over the counter. Taken in the correct dosage they’re the safest of the analgesics, but if you overdose on them, like anything else, they can kill you. The Naderite group Public Citizen is pushing to restrict access to the drug. They’ve managed to find a relative of one of the 100 people a year who recklessly and fatally disregard the instructions for use on the bottle to serve as their tragic spokesperson:
"You cannot allow more innocent men, women and children to suffer," Kate Trunk, whose 23-year-old son Marcus died of an unintentional overdose, told a panel of Food and Drug Administration advisers. "Death is not an acceptable side effect." About 100 people a year are believed to die from unintentional overdoses.
Willfully ignoring the instructions on the bottle hardly classifies one as an “innocent victim,” nor does it constitute an “unintentional overdose.” It might not be a suicide attempt, but the overdose is very definitely intentional. The real problem is when people take Tylenol in combination with other products that also contain acetaminophen, such as prescription pain relievers and over the counter cold remedies. (As my public service for the month, here’s a list of products that contain acetaminophen. [warning: pdf file].)
In view of this, the call for better labeling of content and warnings about the danger of overdosing on over the counter acetaminophen products is justified, but Public Citizen wants to go even further and restrict the use of Tylenol. They want warnings not to take it for more than ten days, which would deprive many arthritis sufferers of a safe and effective means of treating their arthritis pain, and they want it sold only in very small quantities, like antihistamines are. They also want a doctor’s order to dispense more than 100 tablets. That’s going too far. The publicity over this, regrettably, is already making patients shy about using the drug. I had a couple of people tell me yesterday that they would rather use other over the counter analgesics for their minor arthritis pain, like Aleve and Motrin, because of the news reports about Tylenol’s dangers. Those drugs, unlike Tylenol, can cause bleeding ulcers and kidney damage, even when taken in the correct dose, making them riskier than Tylenol. If Public Citizen is truly concerned about public safety, they should consider the full consequences of their political action. posted by sydney on
9/21/2002 08:10:00 AM
Of Patents and Images: Derek Lowe has, as usual, an excellent discourse on the patent and public image problems of drug companies. He asks:
How did the drug industry get to be so unpopular? "Murray suggests that much of the problem is internal - pharmaceutical PR has been so heavy-handed that people assume that we must have something to hide. He suggests that the industry lobbying group, PhRMA, give up the front-group ads and campaigns, and reign in the marketing excesses that make it look like we have to buy doctors to prescribe our drugs. He concludes "If the drug industry wants less criticism from the public, it will have to start by giving people less to criticize.”
There’s an even more fundamental reason people hate drug companies - drug prices. When they hear how much cheaper drugs are in Canada, they assume that the drug companies are price gouging here. That may not be true, but that’s the perception, and nothing stirs a visceral dislike more than the perception of being played for a fool.
COMMENT: A reader emailed this defense of drug prices:
It's not at all clear what "price gouging" means in the context
of drugs.  Drugs are effectively an "information good" in that
the upfront development cost is very high but the marginal cost
of production is very low. This has two implications:
(1) In order to make a long-term profit you need to charge
much more than it costs to make the product. In
order to do so you must have at least a temporary
(2) You have something like a monopoly so you can practice
what economists call "price discrimination".
The reason for price discrimination is simple. If you charge too high
a price you price people out of the market. Since every extra unit
sold brings you some profit, this is bad. If you price too low you
forego the opportunity to make a bunch of money from people who would
pay more. So, if you set one price, no matter what you do you forego
The idea behind price discrimination is:
(1) Figure out some way to differentiate between people who
are willing to pay more and those who won't.
(2) Stop people who are willing to pay more from getting
the product at the cheaper price.
Generally it's not possible to do this perfectly, but doing an OK job
is possible in many cases. The classic example is airline
tickets. Business travelers are less price sensitive but more schedule
sensitive. Thus, airlines offer discounts preferentially to vacation
travellers by requiring cheap tickets to be bought well in advance and
for inconvenient travel times (like staying over Saturdays).
A similar situation obtains with drug sales to Canada. The Canadian
government isn't willing to pay as much as American HMOs and so the
drug companies lower their prices to Canada rather than forego sales
in Canada entirely. They couldn't afford to sell drugs in the US at
that price. 
This may seem unfair, but price discrimination allows products to be
sold that otherwise wouldn't exist. Consider the following example,
lifted from Hal Varian's Pricing Information Goods. Imagine that a publisher manufactures an electronic book. It costs $7
to make the first copy and $0 to produce additional copies.
Now, there are two consumers, A and B. A is willing to pay $5 for the
book and $B is willing to pay $3. Now, there's no single price at
which this book can be sold since at $3 both A and B buy but the
publisher only makes $6, which isn't enough to recover costs. At $5
the publisher only sells to A and only recovers $5. In either case he
loses money. The only way to make money with this cost and demand
structure is price discrimination. If the publisher can price
discriminate (e.g. charge A 4.75 and B 2.75) then everyone is
I don't expect any scheme designed to equalize prices between
the US and Canada to have the desired effect. Rather, I expect
one of three things will happen:
(1) Drug companies forego the Canadian market entirely.
(2) There's a uniform price that is very much higher than
the current Canadian price and only very slightly lower
than the current US price.
(3) The price falls to the Canadian price and the
number of new drugs produced drops dramatically
since the potential profit is so much lower.
 Actually, to an economist, it's not at all clear what price
gouging means, period.
 This is what is provided by drug patents. Once the patents
expire the drug becomes a commodity and so the price gets driven
down to near the marginal cost of production.
 If drug companies COULD afford to sell drugs in the US at
those prices then it would pay one of the companies to start
offering their drugs at lower prices and capture the market.
Consider, for instance, the case with PPIs. Aciphex and Prilosec
aren't totally substitutable since some people prefer one to the
other, but they're mostly substitutable and if Aciphex were half
the cost then it would be the first round drug of choice and
would dominate the market, since it's good enough for most
All of these are valid points. That’s why I was careful to use words like “perception”, “assume, and “may not be true.” The reality, however, is that the average consumer puts the blame squarely on the drug companies. Believe me. I listen everyday to rants about greedy pharmaceutical companies and greedy insurance companies executives. The “root cause” of my patients’ discontent is always the high prices they have to pay for their drugs and their insurance policies. They don’t care about the finer economic points. Even a misperception can have powerful force if enough people believe it. posted by sydney on
9/21/2002 07:18:00 AM
Keeping Abreast: We may not be sure if breast cancer screening makes any difference in mortality, but that isn’t stopping the radiologists from finding ways to expand screening programs, not to mention their profits. Now, they’re suggesting that mammograms should be supplemented by ultrasound exams. The study in question was presented at a conference so it can’t be critiqued, and it only involved women with dense breasts (i.e. young and big breasts) which are difficult to image adequately with mammography. They don’t recommend giving up on mammography, though:
"Ultrasound misses 25 percent of cancers and that's unacceptable," Kolb said. "Ultrasound must be used as an adjunct to mammography."
For now, ultrasound screening isn't an accepted technique so insurance won't cover it. The cost is about $100. Kolb recommends women with dense breast who choose to pay for the test find someone who does at least five breast ultrasounds a day.
I recommend women take this with a grain of salt. The majority of those dense breasts are in women younger than fifty - an age group in which breast cancer screening is of questionable benefit to begin with. Widespread adoption of ultrasound as a screening method will only serve to increase healthcare costs even further without providing any clear benefit.
More Big Breasts: There’s just no escaping the fixation on big breasts. In other breast news this week, a study confirms the higher rate of false postive mammograms in women with dense breasts. Taken in conjunction with the ultrasound report, you would be tempted to think that using ultrasound along with mammograms would cut down on the number of false positives, but that’s not necessarily so. Widespread use of ultrasounds could result in even more false positives.
Meanwhile, in the New England Journal of Medicine, researchers conclude that big breasts are hereditary. That’s a surprise? They justify their research with the contention that big breasts (or dense breasts) place patients at an increased risk of breast cancer, so it’s worthwhile looking into the genetic source of dense breasts. But wait a minute. The relationship of breast density to breast cancer isn’t at all certain, as this, this, this, and this shows.
Maybe they just wanted the chance to work with big breasts.
UPDATE: An "everyday oncologist" writes to say the dense breasts are more likely related to hormone levels, which is probably true:
I think that the link between breast density and cancer is probably due to estrogen. The risk of breast cancer is highest in patients at the highest quintiles for endogenous estrogen levels. I believe that mammographic density is a surrogate for estrogen levels, and I do not understand why the article did not measure those. posted by sydney on
9/20/2002 08:19:00 AM
Derailing Malpractice Reform: The Naderite group Public Citizen is trying to sabotage Florida’s malpractice reform efforts. Their president is down there accusing doctors of lying about the crisis:
"The AMA and the FMA want to limit patients' rights even further," she said. "They continue to engage in propaganda, deceiving the public by blaming rising malpractice rates on lawsuits and the legal system.
If you want to see propaganda and deception, look at Public Citizen’s website. By the way, Public Citizen is heavily involved in litigation. They have a vested interest in keeping punitive damage awards high, but as the Florida State Medical Association points out, the punitive damages don’t necessarily benefit the plaintiffs:
"One of the reasons we'd like to reform the system is to get more money to the injured patients than they now receive," Cline said, "since they get less than 40 cents on the dollar from the (medical malpractice) rewards that they receive, while the legal system and the attorneys get 60 percent of the awards."
Meanwhile, in Ohio and Georgia, legislators still aren’t convinced that malpractice insurance premiums are caused by large jury awards. Goodness sakes. Where do they think the money comes from, the heavens? posted by sydney on
9/20/2002 06:56:00 AM
In Praise of Dirt: There’s more evidence today that exposure to dirt reduces the risk of asthma in kids:
Children who had relatively large amounts of microbial dust in their bed linens were only half as likely to be asthmatic as children whose sheets contained little of the residue. Furthermore, those who had spent their first year of life on a farm -- which presumably would have given them early contact with the bacterial substances -- appeared to be especially protected.
The findings are the latest evidence supporting the theory that modern man's obsession with cleanliness may be leading to a rise in disorders of the immune system, including asthma.
As someone who is less than meticulous about housekeeping, I’d like to say this study gives definitive proof that scrupulously clean houses are bad for children, but I can’t. The study compares rural children who live on farms to rural children who live in non-farming families. Farming families happen to have higher levels of dust in their mattresses than non-farming families, and lower rates of allergies and asthma. The association could be serendipitous. There might be something else about farming families that’s responsible for the lower asthma and allergy incidence. A better study would have been to group kids by the amount of dust in their bed linens and compare the rates of asthma and allergies to the dust levels. The study only expresses that outcome in terms of odds ratios and in a table that’s incomprehensible. It also mentions that some of the associations they found weren’t statistically significant. Oh, well. posted by sydney on
9/19/2002 08:23:00 AM
Explaining the Unexplainable: Researchers think they've found the source of "out-of-body" near death experiences. There might be something to the explanation. Have you ever noticed that no one ever describes seeing the gates of Hell during these episodes? They can't all be saints. posted by sydney on
9/19/2002 07:15:00 AM
Making Medicine Political: A London Times article describes how two American physicians who printed their views on prostate cancer screening in their local newspaper were treated:
Challenging the worth of this blood test raises strong emotions. Earlier this year the British Medical Journal printed an article by two American clinicians, Gavin Yamey and Michael Wilkes, who had questioned the value of PSA screening in a US newspaper, arguing that it was unreliable and caused people to have radical, debilitating treatment when they didn't need it. They described how they had been vilified as a result - they were accused of "geriatricide", bombarded with angry phone calls and their university was urged to fire them. "There is a widespread belief," they concluded, "that screening really does make a difference . . . but it is a belief driven by politics and not evidence." posted by sydney on
9/19/2002 06:41:00 AM
Celebrity Medical Watch: Christopher Reeve may have made a recent medical breakthrough in the treatment of his paralysis, but that hasn't stopped him from blaming Catholics and Republicans for his continued plight:
"There are religious groups - the Jehovah's Witness, I believe - who think it's a sin to have a blood transfusion.
"Well, what if the president for some reason decided to listen to them, instead of to the Catholics, which is the group he really listens to in making his decisions about embryonic stem cell research?" Reeve told The Guardian.
Meanwhile, stem cells are being genetically mapped, a step that will take us one step further in understanding how to use them in the sorts of experiments that Reeves laments. posted by sydney on
9/18/2002 05:59:00 AM
West Nile Virus: The virus spreads to Canada. Those pesky birds and mosquitoes. How dare they cross the border without checking with customs. posted by sydney on
9/18/2002 05:51:00 AM
Shocking: Using high concentrations of sound waves to "shock" a chronically inflamed heel has gotten bad press from an Australian study. This isn't a therapy that's used much in the United States. It's still experimental. posted by sydney on
9/18/2002 05:31:00 AM
Tuesday, September 17, 2002
Guidelines Strike Again: The United States Preventive Services Task Force strikes another blow to attempts to curb healthcare costs by recommending osteoporosis screening every two to five years for women over 65. The task force is charged with evaluating the available evidence on various preventive medicine topics such as screening for cancer and other conditions and making recommendations on their general worthiness. Lately, they’ve been sloppy in discharging their duties, and this recommendation is no exception.
Although the recommendation to have a special x-ray every two to five years to check for osteoporosis may seem innocuous, it has a very serious potential to ratchet up the cost of healthcare even further without any evidence that it will improve overall health. The tests cost between $125 to $200 each. That means that if we follow the recommendations of the task force a woman (or more likely her insurance company) will have to spend $2,000 to be screened over the twenty year span that they recommend. As of 1999, there were about 17 million women in the US between the ages of 65 and 85, the age group in which screening is recommended. The cost of screening every woman in that group over the twenty year span would reach $34 billion, and that’s by 1999 population statistics. That number will only increase dramatically as the baby boomers age.
Neither the effectiveness of osteoporosis screening nor its treatment have been established, as the Task Force freely admits:
No controlled studies have evaluated the effect of screening on fractures or fracture-related morbidity.
...No randomized trial of treatment for osteoporosis has demonstrated an impact on mortality.
...There is little evidence regarding which patients are likely to benefit from screening and treatment. It is not known whether women who have a similar overall risk for fracture, but different bone densities, will benefit similarly from treatment. This uncertainty is clinically important because the lack of accepted criteria for initiating treatment remains a problem.
As before, the Task Force relied on the dubious technique of meta-analysis to determine their recommendations, and they went even further by making statistical assumptions and projections based on the meta-analysis.
Another caveat needs to be added in that we don’t know the long term consequences of taking the drugs we have to treat osteoporosis, although we do know the long term financial impact. Fosomax costs about $65 a month and can cause ulcers. It’s been on the market for the treatment of osteoporosis for about five years. We have no idea what kind of side effects it may have after twenty years of use. Estrogen is cheaper, can be had as a generic, and has been in longer use, but it was defamed last month by the Women’s Health Initiative study. Miacalcin is also expensive at $63 a month, probably safe, but not considered as effective as drugs like Fosamax. Evista, which is approved only for osteoporosis prevention but has hopes of being approved for treatment, costs $67 a month and again has only been in use for about five years. Of all of these, estrogen is the only drug that has even come close to being evaluated for long term use, and look what happened to it.
With the Task Force coming out in favor of screening, the pressure will be on for insurance companies and Medicare to pay for it, for doctors to screen for it (to not do so could be perceived as providing inferior care), and then to subsequently treat it. The potential costs are staggering. The potential benefits are unknown. It’s disheartening to see the Task Force making recommendations such as this withhout fully considering the consequences. posted by sydney on
9/17/2002 08:14:00 AM
World Trade Center Cough: The Washington Post describes Ground Zero rescue workers as plagued by respiratory ills. The story is based on this study from last week’s New England Journal of Medicine. But, given the amount of dust and debris in the air after the World Trade Center’s collapse, the astounding thing is that there aren’t more breathing problems among the rescue workers.
Despite the Post’s claims that the breathing problems are a “plague”, the study found that out of 1,636 firemen who were at the site on September 11, 2001, the day when the dust was at its highest concentration, only 128 (8 percent) developed breathing problems. In the 6,958 firemen who worked at the sight in the next two days, when the dust was still settling and the fires still burning, only 187 (3 percent) developed problems, and of the 1,320 rescuers who worked there between the third and seventh day after the attack, only 17 developed problems. (1 percent).
These are remarkably low numbers, especially given some of the descriptions by the firemen themselves of what it was like down there on that first day:
A healthy 45-year-old deputy chief who had never smoked arrived at the World Trade Center shortly after the second jetliner's impact. He supervised medical triage directly in front of the south tower when it collapsed. He was buried under falling debris, from which he was able to extricate himself. He reported that the air was "darker than a sealed vault and thicker than pea soup"
...Within 24 hours after exposure, all 332 firefighters with World Trade Center cough reported having a productive cough; the sputum was usually black to grayish and infiltrated with "pebbles or particles."
The Post interviews a lung specialist from Mount Sinai, who can’t resist the temptation to slam his generalist colleagues:
He said he has seen too many patients misdiagnosed by primary care doctors unfamiliar with treating serious chemical burns. "It doesn't leave us confident that they will get appropriate evaluation and care," Levin said.
These people aren't suffering from chemical burns so much as they're suffering from inhaling dirt. The specialists don’t have any experience treating people who have inhaled pebbles, either. They’re guessing at the best treatment, which is the best that anyone can do under the circumstances. posted by sydney on
9/17/2002 06:39:00 AM
West Nile Update: A reader sent this link about a possible Cuba connection to West Nile virus:
Roberto Hernandez, another exiled Cuban scientist, says, "We were instructed to look into viruses such as encephalitis which are highly resistant to insecticides. Military-intelligence officers running the labs ordered us to trap birds with migratory routes to the United States with the idea of releasing contaminated flocks which would be bitten by mosquitoes which, in turn, infect humans."
Maybe Castro did look into this, but if he and his henchmen chose it as a weapon, they made a poor choice - both in terms of the agent and the means of transmitting it. For all the hype, West Nile is still less deadly than influenza and far less prevalent. Infecting migrating birds in the hopes they’ll infect Americans is the equivalent of sneezing on your enemy. posted by sydney on
9/17/2002 06:01:00 AM
When Giants Walked the Earth II:Dr. Orvan W. Hess, one of the men who developed the fetal heart monitor, died at age 96. Although famous for the fetal monitor, he also dared to use penicillin when it was still an experimental drug:
In 1942, one of his obstetrics patients contracted scarlet fever, which caused a miscarriage and subsequent streptococcus infection.
"Doctors had done everything possible, both surgically and medically," Dr. Hess said in a 1998 interview with Katie Krauss, the editor of Yale-New Haven Magazine and one of the many babies Dr. Hess delivered. "I went to see her and knew she was dying."
Dr. Hess wanted to talk to her internist, Dr. John Bumstead, and found him asleep in the library. "While I was waiting for him to wake up," Dr. Hess said, "I sat and read the latest Reader's Digest, in which there was an article called `Germ Killers From Earth,' about the use of soil bacteria to kill streptococcal infection in animals."
He asked Dr. Bumstead, "Wouldn't it be wonderful if we had something like this gramicidin mentioned in the Reader's Digest?" This prompted Dr. Bumstead to speak with some colleagues who were studying penicillin and to obtain some for the patient, Anne Miller. The day after her first injection, Mrs. Miller's fever broke. She lived to be 90 years old, dying in 1999.
Try to imagine something like that happening in today’s litiginous environment. Imagine if it didn’t work and the patient died , as she would have without the antibiotics. Can’t you just hear the prosecuting lawyer, “And what was that you gave the patient? An extract of mold? And where did you learn about it? The Reader’s Digest?” posted by sydney on
9/17/2002 05:53:00 AM
Man's Best Friend: A Danish doctor has made a rather unique use of his dog:
Dr Kaj Winther, the physician who heads the department of clinical chemistry at the University of Copenhagen, has two great interests. His major work involves cardiovascular disease, but he also has a great interest in PMS. He has, as have most men, personal experience of it. For a few days each month the Winther household treads gingerly - even compliments and sympathy can be dangerously misunderstood. Dr Winther suddenly realised that his dog Sussi, a friendly kleiner munsterlander, gave him the first warning of when extra tact, consideration and diplomacy had to be the order of the day. Sussi, who usually snuggles down on the marital bed, would each month find some other corner of the house in which to sleep. posted by sydney on
9/16/2002 08:03:00 AM
Anthrax Residuals: The New York Times is accusing the government of not doing enough for anthrax survivors. Some of them are complaining of lasting ill health, and they want the government to do something about them. The symptoms, memory loss, fatigue, and rage, are as likely to be from depression, resentment and anger than from biological effects of anthrax. Tellingly, all the survivors who are complaining of these symtpoms work for the postal service, a service fraught with disgruntled employees. The elderly employee of American Media is doing just fine, as is the baby from the ABC offices:
The oldest and the youngest victims of the attacks seem to be among the few who have recovered completely. Ernesto Blanco, 74, returned to work early this year in Boca Raton, Fla., at American Media Inc., which publishes supermarket newspapers. Mr. Blanco said on a recent busy day that he was in very good health.
"I forget some things, but because of my age," he said from his post at American Media. "I'm like a fish in the water, honest to God."
The youngest survivor contracted cutaneous anthrax at the age of 7 months after his mother, a television producer, took him to visit her colleagues at the ABC studios in Manhattan. The infection, misdiagnosed for two weeks as a spider bite, became a systemic illness that caused a life-threatening blood disorder and kidney failure. The baby recovered fully, but his mother said doctors had cautioned her that kidney problems could in theory develop later, because the illness was so severe.
In theory, these two were at the highest risk for complications because of their ages, yet they’re faring much better than the healthier postal employees. At the time of the attacks, it was the postal employees, too, who complained that the government wasn’t doing enough to protect them. Anyone else see a pattern here? posted by sydney on
9/16/2002 08:02:00 AM
Not So Modern Medicine: The story of aspirin. As an aside, the origin of the word aspirin to denote acetyl salicylic acid has shades of its garden origins - A for acetyl, SPIR from Spiraea ulmaria, the botanical name for meadowsweet, one of the shrubs from which the salicylic acid can be extracted, and IN, a common chemical suffix used to denote a manufactured substance. posted by sydney on
9/16/2002 08:00:00 AM
Smallpox Vaccine Update: More of the Bush Adminstration's plans for smallpox protection have gone public. Now the estimates are up to 1 million vaccine recipients. I have a feeling that as they offer the vaccination and perfect the logistics of a voluntary vaccine program as well as assess the actual complication rate, we'll eventually get to a mass voluntary vaccination program. posted by sydney on
9/16/2002 07:59:00 AM
When Giants Walked the Earth: The demise of the last survivor of the golden age of medicine. According to the obituary the doctor began seeing patients at 8AM each morning, took a half hour off for dinner at around 5PM, then made housecalls until 12 midnight. When did he do his paperwork, let alone father his children? posted by sydney on
9/16/2002 07:58:00 AM
A Mother's Love: The next time anyone is tempted to think that the mere fact of being a woman confers a person with nobility and goodness, they should remember this woman. The only thing good about her that anyone, even her friends, can recall is that she loves her son. So did Ma Barker. posted by sydney on
9/16/2002 07:56:00 AM
Sunday, September 15, 2002
Passion’s Regret: The morning after pill is in the news again. This time, its advocates are agitating to make it over-the-counter. The Reuters story was spurred by a Sounding Board article (the equivalent of an op-ed piece) in the New England Journal of Medicine by David A. Grimes (requires subscription to access). Dr. Grimes is a gynecologist and oral contraceptive advocate. He’s gone on record promoting the continuous use of birth control pills to abolish menstrual cycles (periods are so annoying don’t you know). His NEJM article is an outstanding piece of Pill boosterism. You could call it a Pill manifesto.
He calls for the FDA to waive their usual standards before approving the drugs for over-the-counter use, largely on the basis that the morning after pills are safe and innocuous. He goes so far to claim that they’re as safe as aspirin, and to accuse the FDA of jeopardizing women’s health by delaying the decision to make them over the counter.
Now, it is certainly true that if taken correctly, the emergency contraceptive pills, Plan B and PREVEN™, have a low rate of serious side effects, and are effective at preventing pregnancy (1% and 3% failure rates respectively). They do have a high rate of nuisance side effects, most noticeably nausea (as high as 50%) and vomiting. But the greatest concern with making them over the counter is the potential for abuse. They are essentially high dose oral contraceptives. If made available over the counter, there is a good chance that many young women ( especially teenagers and college students) would use them regularly in place of safer long-term daily oral contraceptives. Dr. Grimes argues that this hasn’t turned out to be the case in European countries and some parts of Canada where it’s already available over the counter, but he’s ignoring one crucial factor that plays heavily in the use of medication in our country - advertising.
Both Preven and Plan B already have direct to consumer advertisements directed at college age girls and teenagers. Plan B has a campaign centered around posters of hunks that urge young girls to have a back up plan (Plan B) if the hunk fails to protect them. Preven has gone the route of appealing to everyone’s stronger inner woman, relying on Rosie the Riveter to get their message across. The message, however, is clear in both campaigns - back up your condoms with the morning after pill. It will be all too tempting for young women to use the pills every time they have sex, rather than in the occasional “emergency” as they were intended. The pills may be safe for occasional use, but taking them two or three times a week would raise their risks and side effects substantially. It would also give women a means for obtaining birth control pills while forgoing their regular pap smears and pelvic exams. (Exams that women loathe more than going to the dentist.) If this should turn out to be the case, then we can expect to see more cases of pelvic inflammatory disease and cervical cancer because screening exams were deferred. Casually making oral contraceptives over-the-counter could, in the long run, be far more dangerous to women’s health than the unintended pregnancies that worry Dr. Grimes.
As for Dr. Grimes, one has to wonder why he is such an unremitting Pill booster. His article identifies him as a member of a group called Family Health International, a nebulous organization devoted to promoting and researching world reproductive health. That certainly sounds admirable and non-profit, but the descriptions of the organization on their website are all quite vague when it comes to the details of who started the group and how they are financed. They aren’t a government agency, but they also aren’t a charity. They say they are a “vehicle for new business ventures, including research and development services for pharmaceutical, biotechnology and medical device companies.” Could they (and he) be representing the interests of the pharmaceutical companies? posted by sydney on
9/15/2002 08:33:00 AM
Bioterror Update:Derek Lowe is posting this week on chemical weapons and terrorism. As always, his posts are lucid and informative. The US Army has a good overview of the history of chemical warfare here, as well as information on treating chemical casualities. posted by sydney on
9/15/2002 08:32:00 AM
Taking Risks: Here’s a counterpoint to the previous post on the FDA and the controversial bowel drug, Lotronex, from a couple of days ago:
Many people would be willing to accept a slightly higher risk of death in exchange for a large improvement in their quality of life. Many surgeries are performed to treat conditions that aren't life-threatening, yet surgery itself increases the risk of death--do you think these surgeries should be banned too? Do you think patients who have their wisdom teeth removed should be prohibited by the federal government from receiving anesthesia? What do you think the optimal speed limit on federal highways is? 65 mph? 55 mph? Why not 5 mph--sure this would be inconveient, but fewer people would die in traffic fatalities.
I am taking the argument to the extreme, I know, but I think the extreme examples illustrate the fact that people trade off mortality risk for quality of life all the time. There is nothing wrong with that. Since different people value mortality risk and quality of life differently, I think these tradeoffs should generally be made on a decentralized basis by doctors and their patients, not by the FDA. I would make an exception to this rule for drugs for which no reasonable person could think that the health benefits exceed the mortality risk (like thalidomide in pregnant women), but I think those should be exceptions not the rule.
For some cases, that’s true, but the issue here is whether or not the drug is as safe as the company is making it sound. I didn’t quote the entire BMJ article in the last post, but it also pointed out that the main bone of contention between the FDA advisors who are speaking up now and the FDA adminstrators was the actual incidence of potentially fatal side effects. The advisors estimate that the incidence could be as high as 1 in 200 users. That’s much higher than the risk for elective surgeries. The company disputes that, but hasn’t given enough concrete evidence to be convincing. The advisory panel was willing to allow compassionate use within clinical trials while the review continued, but the drug company refused. They had brought the drug to market with the intention that this would be a “blockbuster” for them, and restricting its use would foil their profit plans. They also got the FDA to forgo strict rules about who could prescribe the drug. The advisory panel recommended that it be issued only by doctors who were certified to use it, but in the final re-approval it can be given by anyone who thinks they know enough about it to give it. That means that I could prescribe it after reading the package insert if I thought that was sufficent knowledge.
The other disturbing aspect of the article was this revelation:
The International Foundation for Functional Gastrointestinal Disorders, which did have funding from GlaxoWellcome, also pushed for the drug's return. Its president, Ms Nancy Norton, testified at all three advisory committee meetings without revealing her organisation's link to the manufacturer. Asked why not, she says she was not specifically asked, and that the link appears on her foundation's website. (The website buries that information in a link that appears under the subheading “I am a - choose one: patient, health professional, donor. You would only stumble upon their drug company ties if you hit donor, which few people would do.)
There are now so many ways for drug companies to use their financial clout to influence regulatory decisions it’s impossible to keep track of them. Between their contributions to politicians, the FDA, and the disease activist groups that lobby them, they’ve got all the bases covered. It should come as no surprise that they were able to quash the evidence the advisory committee was gathering on the drug's risks. posted by sydney on
9/15/2002 08:19:00 AM