"When many cures are offered for a disease, it means the disease is not curable" -Anton Chekhov
''Once you tell people there's a cure for something, the more likely they are to pressure doctors to prescribe it.'' -Robert Ehrlich, drug advertising executive.
"Opinions are like sphincters, everyone has one." - Chris Rangel
Cause for Pause: The San Francisco Chronicle is reporting an RU-486 related death:
Monty Patterson said his daughter Holly Patterson had visited Planned Parenthood in Hayward last Wednesday and on Saturday had begun taking drugs prescribed to end her pregnancy. Patterson's daughter lived with him in Livermore and did not tell him about the pregnancy, he said.
"On Sunday, she was crying and crying, and she told me she was having cramps, that she had a bad period," said Patterson, a home builder who said he had learned of the pregnancy only hours before his daughter died.
Between Sunday and Wednesday, Holly Patterson was bleeding severely, in acute pain and unable to walk, her father said. Her boyfriend rushed her late Sunday to Valley Care Medical Center in Pleasanton, Patterson said. She was given painkillers and released, Patterson said.
"She went back into the hospital in the middle of the night Wednesday, and she died at 2 p.m.," Patterson said. "The doctor told me that she hadn't aborted all of the fetus, and she had fragments left in her, and she had a massive systemic infection and went into septic shock."
She isn’t the first:
Last year, the Washington Times reported that the deaths of two women who took RU-486 had prompted the FDA to issue warning letters to physicians.
Three women who took RU-486 later suffered bleeding caused by a ruptured ectopic pregnancy, the Washington Times reported. One woman died from a hemorrhage. Two other women suffered severe systemic bacterial infections after taking the drugs, and one died.
That RU-486 can kill shouldn’t be surprising. One of the major physiological changes in the uterus in early pregnancy is the formation of new arteries that communicate with the developing placenta. These arteries, designed to bring nutrients to the developing embryo, are characterized by high volumes of blood flow with very little low resistance. Mifepristone makes the tissue around those arteries (and the tissue composing those arteries) die and fall away. When that happens, the blood in those arteries pumps unimpeded into the uterine cavity. When things go right, the uterine muscle clamps down enough around them to slow the flow. When things go wrong- well, the blood just flows and flows. This can happen in spontaneous abortions, and it’s a known complication of mifepristone; which is why the FDA made a point of requiring that doctors who prescribe it be able to provide emergency surgery to their patients if needed.
It was needed in this case, but not given. Planned Parenthood clinics rarely have 24 hour emergency coverage. Their clinics in my neck of the woods (there are four) only take phone calls during specified hours. Clearly, mifepristone shouldn't be dispensed so nonchalantly.
More to the point, it’s a drug that shouldn’t be dispensed at all. As the FDA itself helpfully explains:
Patients should also understand that safe does not mean risk free; FDA will approve a drug if it determines that the benefits exceed the risks for the approved use.
But, in the case of mifepristone, it isn’t at all clear that the benefits exceed the risks. There’s already a safer alternative to the drug. It’s called surgical abortion (complication rate less than one percent in the first trimester compared to 4 to 8% for mifepristone).
Imagine if there was a drug that could treat gallstones, but 4-8% of users required surgery to treat its complications, which include death. Is there any doubt that the FDA would deny it approval? They would correctly point out that gallbladder surgery is a safer alternative. But then, there is no National Right to Life Without Gallstones to pressure the FDA for approval. posted by Sydney on
9/20/2003 08:36:00 PM
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Fighting Back: A cardiologist who read echocardiograms for lawyers filing a class action suit against diet drug makers has been sued herself for overdiagnosing heart problems in her clients:
A trust responsible for distributing a multibillion-dollar legal settlement to people who took a potentially harmful diet drug sued a cardiologist Thursday, claiming she diagnosed thousands of people as being ill without properly evaluating their health.
The suit, filed by the AHP Settlement Trust, accuses Dr. Linda J. Crouse of turning her Kansas City, Mo.-area practice into an 'assembly line.' The suit said Crouse improperly certified people who had taken the drugs Pondimin and Redux as suffering from valvular heart disease.
....In many cases, the suit claims, Crouse took only a few minutes to evaluate echocardiograms and she rarely met patients in person, reviewed their medical records or took a medical history.
It said that for 11 months of work, Crouse was paid $3.2 million by law firms representing people who hoped to win a share of the $3.75 billion settlement paid by American Home Products, the company now known as Wyeth that made the medications used in the fen-phen diet drug cocktail.
During that time, the trust claims, Crouse signed 2,500 certificates, dubbed "green forms," designating that a person could participate in the settlement.
That's a welcome move. Making dubious diagnoses for class action suits is becoming a bit of a cottage industry in medicine. Asbestos is the worse. Several of my patients have come in saying that they've been diagnosed with asbestosis by "the union's lawyer's doctor." Needless to say, neither the union, nor the lawyer, nor the doctor ever share their findings with me, even when asked. And not one case has been confirmed by our local pulmonologist when I've referred them on. That is if they'll let me. Some of them don't want to have a second opinion - don't want to miss that payout.
(That's not to say I haven't had cases of asbestosis. But curiously, all of my asbestosis cases were not diagnosed by lawyers.)
The FDA is expected to approve the drug for a wide range of mood disorders later this year. According to Bergen, initial research has shown placebo to be effective in the treatment of bipolar disorder, depression, dysthymia, panic disorder, post traumatic stress disorder, seasonal affective disorder, and stress.
As industry analysts predict the drug's sales will top $25 billion in the first year, the approval of placebo is expected to unleash one of the pharmaceutical industry's biggest marketing battles to date.
GlaxoSmithKline expects to have two versions of placebo on the shelves in late December. One, a 40-milligram pill called Appeasor, will be marketed to patients 55 and over, while the other, Inertra, designed for middle-aged women, is a liquid that comes in a 355-milliliter can, and is cola-flavored. Eli Lilly plans a $3 million marketing campaign for its 400-milligram tablet, Pacifex.
Debate: Interesting discussion over at Dean's World on the implication of 3D and 4D fetal ultrasound and abortion on demand. posted by Sydney on
9/18/2003 10:25:00 PM
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Site Malfunction: I just discovered today that this blog hasn't been accessible to Netscape users. I don't know what happens, but since Google bought Blogger, every now and then some glitch turns up in my template. This one is fixed now. So, all of you Netscape users, hurry on back now, y'hear? posted by Sydney on
9/18/2003 10:10:00 PM
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Better than Healthy: Viagra's competitor is gaining on it, thanks largely to its advertising campaign as a lifestyle enhancer:
After one of the most expensive and ribald advertising blitzes in drug industry history, Levitra, the new impotence treatment, has in less than a month captured half of Viagra's market share among new prescriptions.
The secret of Levitra's extraordinary success is an unapologetic push for recreational use.
....GlaxoSmithKline and Bayer, the co-marketers of Levitra, boldly admit that they are focusing on men who may have successful sexual relationships but who simply want to improve the quality or duration of their erections.
...The company's ads feature a young man whose attempt to throw a football through a tire bounces off the side. After Levitra is mentioned, he shoots the ball through the tire again and again and is joined by his attractive wife. Executives at GlaxoSmithKline and Bayer are unapologetic about their attempt to corral healthy men into trying the drug.
Simply achieving penetration and ejaculation — the main goals Pfizer initially set for Viagra — are not the goals set by Levitra's sellers. Sexual satisfaction is. "We've done a lot of research on trying to understand what men want," said Nancy Bryan, vice president for marketing at Bayer. "And what they want is to improve the quality of their erections, to get one that's hard enough and lasts long enough for a satisfying sexual experience."
The age of cosmetic pharmacology is upon us.
(By the way, Levitra appears to have fewer side effects than Viagra, which can cause transient blue vision and precipitous drops in blood pressure if combined with certain medication, but there's no evidence that it's more effective than Viagra.)
Obesity is in the Eye of the Beholder: The Bolshoi has fired one of its star ballerinas because she's too fat:
One of Russia's best-known ballerinas and post-Communist celebrities was fired today by the Bolshoi Theater after a war of insults over whether she was fit for a pas de deux.
Theater officials are charging the ballerina, Anastasia Volochkova, with one of ballet's deadly sins: they say she has become too fat.
How fat is she?
She says she is in top form, weighing in at 109 pounds and following a strict diet.
The Russian press has been reporting that the blonde ballerina, who has the looks of a fashion model and behaves like a star, is nearly 6 feet tall, making her even more unwieldy. Ms. Volochkova said she is 5 feet 7 inches. "She is a modern young woman; she wears heels," her publicist, Gela Naminova, said, explaining the discrepancy.
Maybe she's understating her weight, but her pictures show she's far from fat. It's all in the eye of the beholder.
What's Old is New: All of us have been told at sometime that we have "a virus." Well, now, "a virus" has been identified:
Something called the metapneumovirus, discovered just two years ago, turns out to be an exceedingly common cause of human misery, responsible for garden-variety colds in grown-ups and more severe coughing, wheezing and congestion in children.
Researchers are beginning to piece together the scope of this ubiquitous but overlooked bug, which appears to afflict just about everybody, probably over and over.
Even though the virus seems rarely to be serious, its vast presence intrigues microbiologists, and it is one of the most talked-about topics at this week's meeting in Chicago of the American Society for Microbiology.
Experts say the metapneumovirus is almost certainly not a new bug but something that has been around for eons. posted by Sydney on
9/18/2003 10:55:00 AM
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SARS Coverup?This is pretty damning. Maybe those who blamed Canada's healthcare system for its SARS troubles were right after all. posted by Sydney on
9/18/2003 10:46:00 AM
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The researchers checked lung tissue from 16 patients with primary pulmonary hypertension and 14 with a so-called secondary form caused by other heart and lung conditions. In an antibody test, evidence of herpesvirus 8 turned up in 10 of the primary group -- or 62 percent -- but none of the secondary group. A separate DNA test confirmed the presence of the virus in the first group
The type of herpes virus, Human Herpes Virus - 8 is not commonly found in the general population, so there’s a good chance that its presence in such a large number of patients with primary pulmonary hypertension means that it plays a significant role in its etiology. It’s believed to influence the growth of new blood vessels, which would also conveniently explain its role in pulmonary hypertension. But the question is, how do you get it? Is it transmitted from mother to child in utero? Possibly. Herpes viruses generally are. That would explain why some primary pulmonary hypertension cases appear to be hereditary. Can you get it from exchange of other bodily fluids, like kissing? Possibly. Ah, well, the hazards of love. posted by Sydney on
9/18/2003 10:39:00 AM
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Medicaid Mandarin: I always thought economics would be the deciding factor in whether or not I would continue to see Medicaid patients. The reimbursement is dismal, the patients are challenging both socially and medically, they have a higher rate of no-showing appointments than the general population, and it’s extremely difficult to find a participating specialist when needed. But, it looks like economics won’t be the deciding factor after all.
Yesterday, the managed care company that administers our area’s Medicaid program called to say they wanted to inspect our new office today. The problem is, there is no new office yet. A series of unfortunate events conspired to delay the readiness of my new office space by a month. In the meantime, I’m working temporarily out of two exam rooms and a storage space in my old building while the new tenants remodel all around me. It’s far from adequate. There are too few phone lines, my medical records are in boxes, and all but the most necessary equipment and supplies are in storage. I’ve been limiting the patient visits to only the acutely ill. Operating at full capacity just isn’t possible under the circumstances. And even though I’m following the OSHA, CLIA, and HIPAA rules, any insurance inspector would be put off by the general disarray. Not to mention that this space isn’t really the new office. If they want to inspect the new office, then shouldn’t they inspect the new office?
This point was completely lost on the Medicaid rep. She insisted. My office manager balked. Then, she fired the ultimate threat. If there was no inspection today, then we just can’t see Medicaid patients anymore. To which I can only say, “Adios, Medicaid.”
UPDATE: A reader in the healthcare field says Medicaid reviews are the worst:
As the executive of an mental health agency that is certified, licensed, and/or accredited by Ohio Department of Mental Health, Ohio Department of Alcohol and Drug Abuse Services, Medicaid, Medicare, Ohio Board of Pharmacy, JCAHO, any number of private insurers, and the local mental health board I can assure you that Medicaid reviews are the most arbitrary, conceptually disorganized, bureaucratized and capricious of the lot--JCAHO (believe it or not) stands heads and shoulders above the rest for professionalism and conceptual integrity.
To do this study, Sundeep Khosla and his colleagues at the Mayo Clinic kept track of the wrist fractures among a large sample of kids and young adults who lived in the Rochester, Minn. area from 1969 through 2001. They combed through medical records and found 1,458 wrist fractures.
They found that the incidence of wrist fractures jumped by 42% during that 30-year period, a rise mostly accounted for by the increase in the fracture rate for teens and kids, Khosla says.
The team found the highest fracture rates in girls ages 8-11 and boys ages 11-14 — about a 60% jump. This research also found that the fracture rate associated with recreational activities nearly doubled. No one knows whether kids today run a greater risk of fractures because they're skateboarding or rollerblading more—sports that can lead to falls.
At least the article acknowledges that the fracture rate could have something to do with the types of games children play. In the 1960’s, girls didn’t play soccer and baseball, and skateboard parks weren’t ubiquitous. But it’s the calcium/osteoporosis angle that’s getting the spotlight, probably because the source of funding was the National Institute on Aging:
This study wasn't designed to find the reason behind the increase in the fracture rates. But Khosla and other experts worry that the jump may be related to this fact: From 30% to 90% of kids and teens don't get the recommended three, four or more servings of dairy products or other calcium-rich foods per day.
....The findings raise the concern that kids today aren't building up enough bone, perhaps because they're drinking more soda pop and less milk, the researchers say. Weak bones may put kids at risk of painful and costly fractures, they say.
"Fractures are no fun for kids," says Sherry Sherman of the National Institute on Aging, the federal agency that helped fund the study, which appears in the Journal of the American Medical Association.
Experts like Sherman worry that these same kids might run a future risk of developing osteoporosis, a disease of thinning bone that afflicts about 10 million elderly Americans.
Get paid to look for osteoporosis trends, and by golly, you’d better find some.
Privacy Police Phobia: The new federal privacy rules have put a crimp in patients' spiritual care. Hospitals and nursing homes are afraid to divulge any information, no matter how peripheral. The people who made the rules say that’s wrong :
Some hospitals may be overly cautious or perhaps misinterpreting HIPAA, said Katharina Kopp, program manager of the Health Privacy Project, a Washington advocacy group that helped develop the regulations.
Bill Pierce, spokesman for the U.S. Department of Health and Human Services, said the HIPAA rules govern only health-care information. Hospitals are free to compile lists of religious affiliations and provide them to clergy, but some area hospital officials say they now ask patients if they want to be included on those listings, too.
When the penalty for breaking the rule is prison, who could blame them?
And the most amazing thing about the privacy rules is that plenty of third parties still have access to the information:
But critics say the government's standards aren't the problem. Rather, they say the problem is medical records are now much too easy to access by a multitude of third parties.
Indeed, says the group, Health and Human Services' "own findings show that the rules affect the medical privacy rights of 'virtually every American,' and allows more than '600,000 entities' access to their records …" That list includes insurance companies, banks, employers, and law enforcement agencies. posted by Sydney on
9/17/2003 08:07:00 AM
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Texas Tort Reform: Tort reform passed in Texas, although both lawyers and doctors say it won't change things for them. GruntDoc, however, is grateful. posted by Sydney on
9/16/2003 08:19:00 AM
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Purple Deluge: Prilosec is going over the counter and on a PR blitz:
P&G is marketing Prilosec OTC in purple packages and drove a purple van through 24 cities in a 'Burntown Challenge' promotion. But the Prilosec OTC tablets themselves are pink -- the color of the magnesium salt used to make the tablets.
P&G expects to spend at least $100 million during the first year in marketing Prilosec OTC, including broadcast, print and billboard ads, some featuring a former daytime soap opera star.
So many drugs are making the leap from prescription to over-the-counter now, that the IRS has decided to allow purchases of them with pre-tax dollars.
posted by Sydney on
9/16/2003 08:18:00 AM
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Here Comes the Sun: The WHO has issued a warning about combining sunshine and children:
As ozone depletion becomes more marked, and as people around the world engage more in sun-seeking behavior, the risk of health complications from over-exposure to ultra-violet radiation is becoming a substantial public health concern,” said WHO Director-General Lee Jong-wook.
By reducing the time children and adolescents are exposed to direct sunlight, he said, “we can substantially reduce the risk of contracting skin cancers, cataracts and other conditions which might only appear much later in life.”
Maybe we should just keep our children in boxes. Think about it. It would significantly reduce childhood mortality. It would reduce their contact with infectious diseases, and it would eliminate deaths from accidents. They wouldn't have access to fast food or sweets. We could limit their food intake to only what was necessary for growth, so obesity wouldn't be a problem. By all current measurements they would be declared healthy. They just wouldn't be human. posted by Sydney on
9/16/2003 08:09:00 AM
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Shopping Up North: Illinois is planning to use Canadian drugs for its state employees, and California may soon follow suit. But what does that mean for Canadians?:
But it could eventually bump up prescription-drug prices in Canada.
That fear stems from moves by four of the world's largest drug makers to begin choking off supplies to Canadian pharmacies which reimport drugs to American consumers.
If a national trend toward buying Canadian continues, the supplies are expected to be further curtailed, and big drug companies on this side of the border can put pressure on Canadian prices by controlling supply.
This re-importation thing is bound to be a short-lived solution. Eventually the prices are going to be the same on both sides of the border. posted by Sydney on
9/16/2003 07:53:00 AM
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Yuck: Remember this the next time you go to shake someone's hand:
A survey of hand-washing in airport restrooms found people were especially fastidious this summer in Toronto -- right after the city had endured a SARS outbreak. Elsewhere in North America, people were as slovenly as ever.
The survey was done at airport washrooms in August in Chicago, New York City, San Francisco, Dallas, Miami and Toronto.
It found the dirtiest men were at Chicago's O'Hare and New York's Kennedy. Just more than 60 percent of them stopped to wash.
Teen's Addiction: Just smoking one cigarette makes you a tobacco fiend:
Those first few drags may be the deadliest: Nicotine is such a powerful drug that teenagers can become addicted to it after smoking just one or two cigarettes, according to a groundbreaking study.
Or does it?
The study, published in today's edition of the American Journal of Preventive Medicine, found that, even among those who had tried smoking only once or twice, some teens who experienced cravings associated with addiction.
About 3 per cent of these new smokers were hooked, compared with 4.6 per cent of those who smoked only once a month. The researchers found that one in five teens who smoked weekly showed signs of physical addiction. By the time they were smoking daily, two-thirds showed clear signs of nicotine dependency.
Three percent? So 97% of teens who try a cigarette once or twice show no signs of addiction. Advice to parents of teenagers: don't sweat the small stuff. An experimental drag does not an addict make. posted by Sydney on
9/15/2003 08:45:00 AM
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Therapeutic Amusements: Last week's New England Journal of Medicine had a case study of a man who avoided eye surgery with a roller coaster ride (subscription required):
An eight-year-old boy underwent implantation of a posterior-chamber intraocular lens and a peripheral iridectomy for traumatic cataract. ... At 19 years of age, after having been struck in the right eye, the patient noticed an irregularly shaped pupil. Visual acuity decreased to 20/25. Slit-lamp examination revealed a dislocation of his posterior-chamber intraocular lens into the anterior chamber. The lens was caught anterior to the iris with only the haptics (i.e. the wires that kept the lens in place -ed.) situated behind it. There were no other injuries.
Repositioning of the intraocular lens back into the posterior chamber was attempted with the administration of mydriatic drops to the patient while he lay in a supine position. Only partial repositioning of the intraocular lens was achieved, with half of the lens remaining anterior to the iris. The lens position did not change for the next two weeks, and surgical repositioning was planned for the following week.
On the weekend before the scheduled surgery, the patient took three consecutive rides on one of the largest roller coasters in Europe. After reaching a height of 73 m and being brought to a speed of 130 km per hour, passengers are exposed to a centripetal force of 4 G. Hours later, the patient discovered that his right pupil had become round. Slit-lamp examination confirmed the complete repositioning of the intraocular lens into the posterior chamber.
Roller coasters have also been known to cure vertigo. (Again, archives aren't working. Scroll down to Dec. 2) Amusement parks. Healing power beyond the laughter.
I wrote (or quoted):
"...Three months before presentation, our patient had dismantled the sphygmomanometer in his bedroom spilling mercury on his bed and carpet and had played with it for a day or two before informing his mother. Attempts had been made to dispose of the mercury by vacuuming, and then by flushing it down the toilet."
To which came this response:
The child received the (agreeably tragic) overexposure not from a small amount in the carpet, but from PLAYING with the mercury and spilling it on his bed.
This is typical of the knee-jerk overreaction that I find idiotic.
I don't think a mercury sphygmomnometer belongs in a child's bedroom, but this doesn't mean that we should abolish them from doctors' offices, yet the fear freaks want to abolish them entirely.
Just because a child got a high exposure from days of playing with mercury, does not mean that small amounts embedded in a school carpet are bad, (unless the students are allowed to crawl around and sleep on the carpets.
We've gone from being able to detect parts per million to parts per billion in contamination. People who can't comprehend "the dose makes the poison" want us to now "clean things up" by that increased factor of 1000 just because we can now measure it.
My own law is Frank's law of 10-squared: Removing the next decade of contamination, (going from 99% pure to 99.9% pure for example,) typically costs 10 times more, but only achieves 1/10th the reduction in dose, so the cost per unit effect goes up by a factor of 100. This very quickly renders any extreme cleanup actions financially and socially irresponsible.
And on tourist fatigue:
I was in the tourist business (I owned a "trinket shop") for 17 years. It wasn't as though I was working in Disneyland, but once I counted the number of people entering my shop on a relatively unbusy day, and darned if there weren't some 1,000 people came through that!
But here is the really interesting thing: by the end of the season (and ours only runs for some 5 months), I suffered from an exhaustion that is really difficult to describe, but definitely exists. I think of it as a kind of blankness in the middle of my frontal lobe.
Anyway, my theory is thus: we human beings, for most of our history, have lived our lives among a small unchanging number of people. We are not built to meet - and be welcoming and friendly with - huge numbers of strangers. Thus, in any place with lots of tourists, the locals may start out welcoming these "visitors", but there always comes a time when they resent and even hate the tourists. (I remember here a worried observation by an Israeli, on a 'why do they hate us' riff, talking about how Israeli tourists are disliked even in Nepal.)
Now, because I am betting that this reaction (and it is universal) to tourists is physiological, I would really like to see a study looking into this. Such a study could be financed by tourism associations, and even governments whose countries depend upon tourism.
UPDATE: Yet another opinion on mercury molecules and carpet:
I don't want to belabor the mercury discussion, but I'd like to point out why the hazards are not exaggerated. I do appreciate that "the dose makes the poison", however with mercury the absorbed dose depends on the surface area, which is HIGHLY variable. That means you can't check a contamination problem by measuring vapor concentration. If you get a low reading, it could be a few milligrams of microscopic droplets that will harmlessly evaporate in the next few weeks. Or it could be a big blob, waiting to be turned into micro-droplets with several square meters of surface area. That unpredictability is why industrial hygienists get all twitchy when they hear "mercury" and "carpet" in the same sentence.
One aspect of this variability is that financial risk is almost unlimited. Consider an ignorant janitor who drops a box of mercury sphygmomanometers in storage, "cleans up" the mercury with a vacuum cleaner, then proceeds to use that vacuum cleaner all over the building for weeks. At least several people will get sick; the entire building will have to be shut down for an extended period, the flooring gutted, and furniture replaced; and employee and visitor homes, vehicles, clothing, and furniture checked and decontaminated. Direct cleanup costs for disasters of this type start at $50,000, and the sky's the limit for non-economic damages.
That scenario is neither exaggerated nor theoretical: things like that happen all the time at sites where mercury is used. The following document lists some typical mercury scenarios that actually happened. You can find many more in the industrial hygiene literature. The stuff is truly insidious. posted by Sydney on
9/15/2003 06:41:00 AM
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