The Food and Drug Administration's advisory panel has recommended that the agency reduce the maximum recommended dosage of acetaminophen, an over-the-counter pain killer more commonly known as Tylenol. The drug's potential risk of liver damage is the issue.
And, for a fuller explainer, here's this from MedicineNet: "How is acetaminophen processed (metabolized) in the body?"
"The liver is the primary site in the body where acetaminophen is metabolized. In the liver, acetaminophen first undergoes sulphation (binding to a sulphate molecule) and glucuronidation (binding to a glucuronide molecule) before being eliminated from the body by the liver. The parent compound, acetaminophen, and its sulphate and glucuronide compounds (metabolites) are themselves actually not harmful. An excessive amount of acetaminophen in the liver, however, can overwhelm (saturate) the sulphation and glucuronidation pathways. When this happens, the acetaminophen is processed through another pathway, the cytochrome P-450 system. From acetaminophen, the P-450 system forms an intermediate metabolite referred to as NAPQI, which turns out to be a toxic compound. Ordinarily, however, this toxic metabolite is rendered harmless (detoxified) by another pathway, the glutathione system."
If that's more than you want to know, there's always this from the FDA: "Acetaminophen and liver injury: Q & A for consumers."
It begins: "Acetaminophen is the generic name of a drug found in many common brand name OTC products such as Tylenol, as well as prescription products such as Vicodin and Percocet."
Most people, of course, don't take the more tightly controlled Vicodin and Percocet like candy -- as they sometimes do Tylenol.
“No news is good news” seems to be what most patients assume when they're waiting to hear about test results. But for 1 out of 14 of them, “no news” may in fact mean “bad news” that their doctor didn't inform them about, according to a study published in Archives of Internal Medicine on Monday.
The study, led by Dr. Lawrence Casalino of Weill Cornell Medical College, looked at more than 5,000 records of randomly selected middle-age patients from 23 primary care practices.
The patients had received common blood and screening tests, including mammograms, pap smears, cholesterol tests and red blood cell counts. “Abnormal results” that fell well outside the normal range were reported in roughly one-third of patients. But in 7.1% of these cases, practices did not inform — or document that they had informed — patients.
Communication failures like this could have serious, even lethal, consequences, Casalino says. “We weren’t looking for cholesterol levels that were trivially high,” he notes. Some patients weren't informed of total cholesterol levels as high as 318 mg/dL (above 200 mg/dL is considered high). If left untreated, such levels could eventually mean a stroke or a heart attack for some patients.
Adds coauthor Dr. David Meltzer of the University of Chicago, seeing the numbers “would clearly require a doctor at the very least to have a discussion with the patient” — about lifestyle changes, medication or other forms of intervention.
You might think that switching to electronic medical records would be the solution -- but that's not necessarily so: Computerizing a process that is already being done poorly may yield even worse results, Casalino says. Good processes, using either electronic or paper-based methods, seem to be the key to fewer mistakes.
Casalino and colleagues propose common-sense procedures physicians could use to manage test results, including having the doctor sign off on all results and telling patients to call after a certain time interval if they have not been notified of their results.
Making a few simple changes to automate the system could reduce errors without necessarily making costs higher, Meltzer adds. “A great example would be what happens in an airplane cockpit,” he says. “There are certain pieces of information that are only considered transmitted if they are confirmed. When a co-pilot says to the pilot, ‘We’re running out of fuel,’ the co-pilot’s job isn’t done until the pilot actually says ‘I heard you tell me that.’ ”
Until that happens, however, the study’s authors recommend that patients play an active role in their own care. The single most important message: Don’t assume no news is good news. Know which tests have been done, know when to expect them back -- and if you don’t hear anything, call.
“It’s not hyperbole to say it could save your life,” Casalino says.
Taking Viagra, Levitra or Cialis improves erectile function. That much we now know. Again.
What we still don't know is which medication works best.
At the request of the American College of Physicians, the Agency for Healthcare Research and Quality, part of the U.S. Department of Health and Human Services, set out to assess the impotence drugs' effectiveness and their risk of side effects. Doctors apparently like to have as clear a picture as possible before prescribing the drugs to patients.
The report, released today, distills evidence from 126 randomized controlled trials of the drugs technically known as oral phosphodiesterase type 5 inhibitors. But only four trials compared sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis) against each other, making cut-and-dried conclusions difficult.
Researchers have a pretty good idea of the drugs' benefits. And of their risks -- most common are headaches, flushing, dyspepsia (indigestion -- here's an explainer from MedicineNet) and rhinitis (inflammation of the nose's inner lining -- and another explainer). They just can't tell doctors which one should be prescribed.
But the report does offer one-place-shopping for information on dose-response effect of the individual drugs (higher doses tended to get better results), plus less-conclusive assessments of injections, suppositories, topical treatments, hormones and drugs prescribed off-label. The researchers also tried to evaluate the usefulness of routine blood tests in identifying (and thus, treating) hormonal disorders. The limited amount of data made this problematic.
For most men, and their doctors, the report largely means: If you're looking for a thorough comparative summary of the data on these drugs, now you have one.
Of note, the big three drugs tended to work fairly well across the board. That is, they helped men regardless of the cause of erectile dysfunction. (Here's a primer on causes, courtesy of the Urology Channel.)
And men tended to prefer tadalafil (Cialis) over its cousins, partly because the drug's effects last longer.
The researchers wrote: "There is still insufficient information regarding the effectiveness and safety related to the use of different treatment modalities in various clinical subgroups of patients (e.g. diabetes, cardiovascular disease). Furthermore, there is insufficient data with regard to long-term adverse effects of oral ED medications that have been used by millions of users for over a decade."
Translation: We need more data, especially about how the drugs might affect men with diabetes and heart disease. And long-term data -- we definitely need more of that.
-- Tami Dennis
Photo: Viagra has been often discussed, but not often compared -- clinically speaking -- to its cousins Levitra and Cialis.
If you’ve been waiting on tenterhooks for the winners of the get-a-colonoscopy movie competition put on by the Fred Hutchinson Cancer Research Center in Seattle, we are happy to inform you that the results are in!
“The five winning videos — featuring a stirring survivorship story, a probing puppet and a sinister character named “Colon Polyp,” among other compelling characters — were selected from a pool of more than 60 submissions from contestants spanning 18 states and the District of Columbia,” the center announced today in a statement, and "represented a wide variety of styles and genres.”
Check out the winning entries right here. (A colleague highly recommends “Adventures in Colonoscopy.”)
Enjoy! (And get a colonoscopy if you're of the right age, etc. Information from the American Cancer Society is here.)
The Food and Drug administration announced today that it has notified the maker of Plan B, the morning-after pill, permitting it to market the drug to 17-year-olds without a prescription. The move follows a March ruling by a federal judge that the FDA's earlier decision requiring those younger than 18 to consult with a doctor was not justified on safety grounds.
The pain can occur in the hand of a writer trying to keep up with pearls of wisdom falling from the lips of a particularly talkative professor or in the hand of a musician desperately trying to fine-tune a difficult piece. But it seems to begin in the brain.
In a new study published in Archives of Neurology, researchers in France used a type of MRI to study 26 right-handed people prone to writer's cramp (a type of dystonia) and 26 people not plagued by the problem.
Earlier research had found differences in the gray matter of people prone to writer's cramp, when compared with those without the condition. Specifically, they had less tissue in the cerebellum, the thalamusand the sensorimotor cortex -- parts of the brain affecting senses and movement.
The new research shows that the white matter (made up of message-carrying nerve cells) connecting these regions is affected as well.
Not a stunning discovery perhaps, but every bit of knowledge takes us somewhere.
Botox, it turns out, may be able to help while we get there.
Professional medical associations, which convene meetings of specialists to share study results, draft treatment guidelines and advocate for research, insurance coverage and attention for their fields, must wean themselves off a longstanding financial reliance on companies that make and market the tools of their trade, a group of prominent physicians said today.
"Gifts do matter, organizationally and individually," said David J. Rothman, president of Columbia University's Center on Medicine as a Profession, who led 10 prominent physicians in drafting a road map for doctors' groups to establish their financial independence from the makers and marketers of prescription medications and medical devices. Rothman said it will be "tough" for many physicians' groups to operate without drug and device makers' financial sponsorships. But, he added, "you do not want the piper calling the tune."
The group's road map, which urges medical associations to "work toward a goal of accepting $0 contributions from industry," is published in today's issue of the Journal of the American Medical Assn.It proposes that professional medical associations adopt what Rothman called "a much clearer firewall" between industry money and the continuing education the groups organize for their members. And it recommends that the professional medical associations' officials, leaders and members of essential committees "be free of industry support" so they can speak publicly on behalf of their professional colleagues without apparent or real conflicts of interest.
The JAMA article urges medical associations to take these steps over the next five years to disentangle themselves from drug and device makers' financial support. Though next year's budgets are largely set, the panel urged medical associations to set a goal the following year of having no more than a quarter of their operating budget come from industry sources.
The published guidelines do not object to professional medical associations' acceptance of paid advertising from drug and device makers in their research journals, or to revenue from companies renting space to display their products during medical conventions. Such marketing efforts are clearly identifiable; while they generate revenue that can help support organizations' activities, physicians can fairly assess the information they provide and take account of the information's source, Rothman noted.
Drug and device companies' sponsorship of "continuing medical education" has become particularly controversial in recent years. In 2007, the Senate Finance Committee launched an inquiryinto the practice and estimated that drug and device makers had spent more than $1 billion in 2004 alone to sponsor continuing medical education -- most of it passing through professional medical organizations. Investigators and increasingly, physicians themselves, have charged that industry's support of medical education courses compromises the objectivity of the instruction, often in ways that are not evident to the physicians taking them.
The drug industry's financial ties to physicians and their groups regularly generate Senate inquiries and media investigations. Drug or device companies' gifts, travel expenses or payments made for consulting, research or speaking can amount to millions of dollars yearly for "key opinion leaders" -- many of them medical association officials -- and extra income for many doctors in regular practice. Few believe their clinical judgments are influenced by the payments. But a growing number of physicians have begun worrying that increasingly publicized financial conflicts either cloud physicians' judgments or erode their patients' trust -- or both.
"Frankly, it has not been a very pretty sight," said Dr. Steven Nissen of the Cleveland Clinic, who served recently as president of the American College of Cardiology, and is one of the 11 authors of the JAMA guidelines released today.
One can imagine how electronic drug-prescribing systems could be annoying to doctors -- all those warnings about potential interactions and allergies and whatnot when all you really want to do is give a patient a drug he or she needs and be done with it. It's probably easier to just ignore the blasted alerts and keep going.
That seems to be what's happening. In a study published in the Feb. 9 issue of the Archives of Internal Medicine, most doctors simply shrugged off the warnings issued by their helpful electronic systems.
Out of almost a quarter-million medication safety alerts produced during the study period, the doctors involved accepted only 9.2% of the interaction warnings and 23% of the allergy warnings. In other words, they ignored more than 90% of the drug interaction alerts and more than 75% of the allergy alerts.
The researchers at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center who conducted the study have posted a list of potentially severe medication interactions -- and the acceptance rates of those alerts.
Obviously, if patients are counting on electronic prescribing systems to completely protect them from dangerous drug interactions and allergies in this bold new world of sophisticated record-keeping and safeguards, they may want to reconsider.
As the study's conclusion dryly notes: "Clinicians override most medication alerts, suggesting that current medication safety alerts may be inadequate to protect patient safety."
Over the last decade or two, people have become increasingly disenchanted with their relationships with their doctors. And doctors are ever more dissatisfied with their professions. But a few pioneering medical schools are attempting to rewrite medical education and produce doctors who love their jobs and patients who love their doctors.
A study released this week in the journal Academic Medicine profiles a program at Indiana University as well as four other U.S. medical schools that sought to teach faculty members a different way of instructing medical students. The curriculum emphasized the human dimensions of care, such as the need to communicate effectively, show compassion and build strong relationships. Students rated their professors who used the curriculum, and those ratings were compared to faculty from medical schools that didn't use the program. Students of faculty who were trained in the humanistic model of medicine rated their professors higher in how they demonstrated this type of care, communicated with patients and each other, inspired students and several other measures.
"In the past, medical education has really focused on a punishment model. In principle, you could never do things right," said one of the authors of the study, Richard Frankel, a professor of medicine and geriatrics at Indiana University. "This focuses on the positive."
Besides Indiana University, the medical schools that participated in the study were Emory University, University of Rochester, Baylor College and the University of Minnesota.
Five years ago, Indiana University changed its medical school to emphasize "relationship-centered care," Frankel said. "The whole idea is that if you invest in developing positive relationships between faculty, students and residents, those relationships will transfer to how care is delivered. We've seen a lot of big changes in our medical school as a consequence of this initiative."
For example, young people want to study there. While most medical-school growth has been around 6% to 8% per year in recent years, Indiana University's applications are up 100%. As many as one-quarter of all U.S. medical schools have sent a representative to the school to see the program in action. Clearly, the doctors there are happier. But the ultimate goal, Frankel said, is "to make medicine better for the patient."
The RTS,S vaccine against malaria featured in a Times article today is the closest to possible licensure and use, but it's not the only malaria vaccine candidate. Studies on several others that have also advanced to human trials were presented Monday at a meeting of the American Society of Tropical Medicine and Hygiene underway in New Orleans.
One, under development by the U.S. Naval Medical Research Center and the biopharmaceutical company GenVec Inc., is a genetic vaccine, a newer technology than the protein-based RTS,S. It uses genes found in the DNA of the malaria parasite and delivers them via a de-activated cold virus, prompting the production of antibodies as well as another type of immune reaction called a cell-mediated response.
Another, from the U.S. Military Vaccine Program and the biotech firm Sanaria Inc., is a vaccine that uses an injection of live but weakened malaria parasites to provoke an immune response, much like the measles or mumps vaccines do.
More than one type of vaccine may be needed to beat back malaria, according to Dr. Carlos C. "Kent" Campbell, a longtime director of the malaria program at the national Centers for Disease Control and Prevention. The mosquito-borne parasite that causes malaria is wily. Like HIV, the AIDS-causing virus, it mutates and evades the immune system.
Like many parasites, Plasmodium falciparum also has a complex life cycle, existing in different stages in the liver and bloodstream, making it difficult to target. There is, in fact, no licensed vaccine against any human parasitic disease. Decades of failures have fueled considerable skepticism among malaria experts about whether a vaccine is even possible.
What is not in dispute is that a malaria vaccine is needed, even with the impressive success of insecticide-treated bed nets over the last two years. Campbell pointed out that only one class of insecticide now exists to treat bed nets. So when mosquitoes develop resistance -- and they inevitably will -- gains such as the impressive 69% reduction in severe malaria cases that Zambian health officials announced at this conference could disappear.
Malaria researchers are passionate advocates of vaccines -- especially when confronted with the vocal vaccine critics that have arisen after a controversial paper, since refuted in numerous scientific studies, suggested that the measles vaccine could cause autism. Today's article on RTS,S, for example, has generated e-mail accusations that African children are being used as guinea pigs.
The original guinea pigs were volunteers like Dr. Thomas L. Richie, a U.S. Navy captain who directs the naval research center's malaria program. He and fellow researchers, along with White House policy wonks, doctors from the National Institutes of Health and other volunteers, not only received the first innoculations but agreed to be stung by malaria-carrying mosquitoes to see whether the vaccine worked. "Vaccines are always accepted when the horror of the disease is in front of us," Richie said. "We grew up not seeing measles, never seeing diphtheria."
In the early 1900s, he said, diphtheria swept through New England towns, killing a quarter of grade-school-age children within two weeks. The horror of malaria is still very much at the front in sub-Saharan Africa, where 90% of the estimated 1 million deaths occur each year, most of them among children under age 5.
Tami Dennis, who takes the word "skeptic" to previously uncharted territory, is the Times' Health and Science editor. She's adamant that pitches promoting awareness days, weeks or months are, by their nature, non-stories. And, because she's an adult, she refuses to use words like "veggies," "tummy" and "yummy."
Rosie Mestel, deputy Health and Science editor, studied genetics before abandoning flies, fungi and DNA for health/medical writing. Her hero is the biologist Ernst Haeckel, whose jellyfish paintings inspired snazzy chandeliers. Her favorite toast-spread is Marmite, a British delicacy made of yeast extract. Her least-favorite word is "millenniums."
Melissa Healy is a staff writer for the Health section reporting from Washington D.C. Healy's a veteran of The Times' National staff, having covered the Pentagon, Congress, poverty and social welfare, the environment, and the White House before shifting to Health in 2003. She writes frequently about mental health and human behavior, about federal health policy, prescription medication and ethics in medicine. More wonk than wellness freak, Healy chooses to believe in the health benefits of coffee and wine, and considers water a better work-out medium than beverage.
Karen Kaplan covers genetics, stem cells and cloning. She and colleague Thomas H. Maugh II comprise about 25% of the unofficial MIT-Alumni-in-Journalism Club, and she is proud to have taken more math (5) than English (0) courses in college. Her contributions to Booster Shots will, she hopes, appear more frequently than postings to her mommy blog.
Thomas H. Maugh II has been a science and medical writer at the Times for 23 years. Before that, he was on the staff of the journal Science for 13 years.
He has bachelor's degrees in English and chemistry from MIT and a doctorate in chemistry from UC Santa Barbara.
After a brief stint as a sports writer, Shari Roan turned to health journalism and has covered the topic for The Times for 18 years. She is the author of three books and the mother of two daughters, both teenagers who refer to her as a "health freak." She likes to jog, watch baseball and is very happy that dark chocolate contains some health benefit.
Jeannine Stein writes about fitness, sports medicine and obesity for the Health section. She’s a gym rat from way back and never met an elliptical trainer she didn’t like. Well, maybe one or two. She tempers exercise with a steady diet of reality television because she believes it’s all about balance.
Over the last decade or two, people have become increasingly disenchanted with their relationships with their doctors. And doctors are ever more dissatisfied with their professions. But a few pioneering medical schools are attempting to rewrite medical education and produce doctors who love their jobs and patients who love their doctors.