Saturday, July 24, 2010

Unsafe at Any Meal -

EVERY day, about 200,000 Americans are sickened by contaminated food. Every year, about 325,000 are hospitalized by a food-borne illness. And the number who are killed annually by something they ate is roughly the same as the number of Americans who've been killed in Iraq and Afghanistan since 2003.

Those estimates, from the Centers for Disease Control and Prevention, suggest the scale of the problem. But they fail to convey the human toll. The elderly and people with compromised immune systems face an elevated risk from food-borne pathogens like listeria, campylobacter and salmonella. By far the most vulnerable group, however, are children under the age of 4. Our food will never be perfectly safe — and yet if the Senate fails to pass the food safety legislation now awaiting a vote, tens of thousands of American children will become needlessly and sometimes fatally ill.

Almost one year ago, the House of Representatives passed the Food Safety Enhancement Act with bipartisan support. A similar bill, the F.D.A. Food Safety Modernization Act, was unanimously approved by the Senate Health, Education, Labor and Pensions Committee in November. This legislation would grant the Food and Drug Administration, which has oversight over 80 percent of the nation's food, the authority to test widely for dangerous pathogens and improve the agency's ability to trace outbreaks back to their source. Most important, it would finally give the agency the power to order the recall of contaminated foods — and to punish companies that knowingly sell them.

This bill is supported by an unusual set of advocacy groups: the American Public Health Association, Consumers Union, the Center for Science in the Public Interest, the United States Chamber of Commerce and the Grocery Manufacturers Association, among others. Last week, a poll for Consumers Union found that 80 percent of Americans want Congress to empower the F.D.A. to recall tainted foods.

You'd think that a bill with such broad support, on a public health issue of such fundamental importance, would easily reach the floor of the Senate for a vote. But it has been languishing, stuck in some legislative limbo. If it fails to gain passage by the end of this session, Congress will have to start from scratch again next year.

Food processors reluctant to oppose the bill openly will be delighted if it dies a quiet death. That's because, right now, very few cases of food poisoning are ever actually linked to what the person ate, and companies that sell contaminated products routinely avoid liability. The economic cost is instead imposed on society. And it's a huge cost. According to a recent study sponsored by the Pew Charitable Trusts, the annual health-related cost of food-borne illness in the United States is about $152 billion.

Without tough food safety rules, a perverse economic incentive guides the marketplace. Adulterated food is cheaper to produce than safe food. Since consumers cannot tell the difference between the two, companies that try to do the right thing are forced to compete with companies that couldn't care less.

So the law of the jungle prevails, as Upton Sinclair noted more than a century ago. In those days, many companies had no qualms about selling children's candy colored with lethal heavy metals and rancid food laced with toxic chemicals to disguise the stench; such abuses were widespread. And some of the strongest support for President Theodore Roosevelt's food safety crusade came from processors (like the H. J. Heinz Company) that were outraged by the unfair advantage their competitors gained by selling cheap, dangerous, adulterated food.

The Pure Food and Drug Act of 1906 helped to eliminate many unsafe practices. But the recent centralization and industrialization of the American food system poses new kinds of threats.

Today, a problem at a single factory can swiftly lead to an outbreak that extends nationwide. Last year's peanut butter recall illustrates what can go wrong. Executives at the Peanut Corporation of America knew that peanut butter from their filthy, rodent-infested plant was testing positive for salmonella — but shipped it anyway, for months.

Thousands of different products, manufactured by more than 200 companies, including candies and cookies marketed to children, were potentially tainted thanks to that one plant. And in the end, roughly 20,000 Americans got salmonella; about half of them were under the age of 16 and one-fifth were younger than 5.

The enormous rise in imported food also exposes American consumers to food safety lapses overseas. In recent years, China has been responsible for food scandals that bring to mind the United States in the days of Upton Sinclair: Chinese companies have been caught adding lead-based whiteners to pasta and selling beverages made with industrial alcohol. Two years ago, almost 300,000 Chinese infants were sickened by baby formula that had been adulterated with melamine, a cheap but toxic chemical. The overuse of antibiotics and pesticides in Chinese agriculture is rampant.

Despite those food safety problems, China has become the largest exporter of food to the United States after Canada and Mexico. About 60 percent of the apple juice in America — like peanut butter, a product consumed largely by children — now comes from China. This is yet another reason that passage of the F.D.A. modernization act is so urgent; it would, for the first time, subject foods from overseas to the same standards as those produced in the United States.

Last year, President Obama called for measures that would "upgrade our food safety laws for the 21st century," and this bill is a good first step. The president has asked lawmakers to pass the legislation, saying that it would provide "the federal government with the appropriate tools to accomplish its core food safety goals."

For months, however, the Internet has been rife with wild rumors and accusations: that the bill is really a subterfuge cleverly designed to eliminate small farms and strengthen the grip of industrial agriculture; that it would outlaw organic production; that it would hand over the nation's food supply to Monsanto.

Those arguments may be sincere. But the bill very clearly instructs the Food and Drug Administration to focus its enforcement efforts on plants that pose the greatest risk of causing large-scale outbreaks. And the bill's wording can still be clarified so that mom-and-pop producers aren't threatened by heavy-handed government regulations.

What the legislation actually seeks is some restraint on unchecked corporate power. We've seen what happens when Wall Street is allowed to regulate itself and when the oil industry is allowed to regulate itself. How could it possibly make sense to let the food industry continue to write its own rules?

I've come to know families that were devastated by a food-borne illness. A great deal of harm, inflicted on some of the weakest members of society, can be avoided with a few simple reforms. Nobody should lose a child because the Senate lacks the will and the leadership to act.

How Not to Fight Alzheimer’s -

A panel of medical experts from the National Institute on Aging and the Alzheimer's Association last weekproposed changes in the way doctors diagnose Alzheimer's disease — including the use of so-called biomarkers, tests like PET brain scans and analyses of spinal fluids to promote early detection of the disease. Although these recommendations are well intentioned, evidence suggests that it would be a mistake to adopt them at this time. To understand why, it's important to recognize what these tests mean, in what context the information will be used and what experience has shown us.

First, about the diagnostic tests: A PET scan detects clumps of a deformed protein called amyloid beta, commonly known as plaques. The presence of these plaques has been a gold standard of Alzheimer's pathology since 1906, when Dr. Alois Alzheimer first identified them in a patient.

However, we now know that roughly one-third of all elderly adults have such plaques in their brains yet function normally. And eleven clinical trials, recently made public by a group of drug companies, that were aimed at reducing these plaques in Alzheimer's patients all failed to show cognitive improvement, even when the brains were cleared of plaques.

Thus, the presence of plaques cannot predict with any accuracy or specificity that an individual is going to acquire the disease — and researchers are increasingly looking beyond the amyloid hypothesis for an adequate explanation for Alzheimer's.

Another test being recommended by the panel is spinal fluid analysis — which measures the relative levels of two proteins, tau and amyloid beta. This method does seem quite promising, but its predictive potential remains uncertain.

There are also practical issues to be considered, not least of all the high cost of these procedures. What's more, the spinal tap procedure is not easy to perform and is painful to undergo, and it is a long way from becoming a routine diagnostic tool. Dr. Janis Petzel, a geriatric psychiatrist in Maine, has noted how unfeasible this test is in "nonacademic, rural or non-Western settings": "I pray that cerebrospinal fluid findings will never be part of diagnostic criteria for Alzheimer's disease," she wrote.

The diagnostic tests themselves can carry a risk of side effects. General imaging scans can expose patients to radiation, for instance; an invasive spinal tap could result in infection or damage to tissue. But there is also the psychological risk of false positives and misdiagnoses that greatly distress patients, at least until further tests show they do not have the disease.

This danger of overdiagnosis is very real, as the history of treatment for prostate cancer shows. A study last year about the prostate-specific antigen test found that in the two decades after the test was introduced, prostate cancer was detected in more than 1 million additional men, many of whom were likely overtreated.

Last, the most dreadful thing about Alzheimer's disease, next to the slow deterioration of cognition, is that we do not yet have a cure and none seems to be on the horizon. So, even if the new recommendations rendered the diagnosis earlier and unassailable, there is no therapeutic avenue to use this information to effectively treat the patient. Many individuals would simply prefer to be spared the emotional trauma of a diagnosis if no treatment exists.

Taken together, these reasons suggest that the panel's recommendations are likely to increase the emotional burden on individuals and the financial burden on society without providing proportional benefits. The doctor's most basic tenet is that of primum non nocere — first, do no harm. Until we have a more definite idea about what causes Alzheimer's, early-detection tests may do patients more harm than good.

Letting Patients Read Their Doctors’ Notes -

Their request seemed simple enough: the patient and his wife, both in their 70s, wanted a copy of what I'd written in their medical file. During their visit, I had watched them refer to a well-thumbed collection of doctors' notes and medication lists, so when they asked for a copy of my note just before leaving, I assumed it would simply be added to the others.

But when I mentioned the request to one of the nurses outside the exam room a few minutes later, her eyes grew wide.

"Oh no, you can't do that," she said, shaking her head. "I don't think it's legal." The other doctors and nurses, attention piqued, moved closer to listen. "Send them to medical records," she urged. "He can sign the release papers there."

Another nurse in the growing crowd offered her own advice. "Do you know what's going to happen if you give them a copy now?" she asked. "They're going to start calling and e-mailing you with questions about what you wrote."

The doctors and nurses began clucking in agreement. "Think about it for a second, Pauline," one doctor said with voice lowered. "Maybe they are thinking of suing you."

There was a collective gasp from the group now gathered around me; and I could guess what they were thinking as they craned their necks to peer into the exam room where my elderly patient was busy fussing with his papers as his wife stood adjusting the canvas fishing hat on his head.

The barbarians are at the gate.

For 40 years, the tension over patient access has been playing out in hospitals, clinics and doctors' offices. Although medical records have always been accessible to clinicians, payers, auditors and even researchers, it was not until the 1970s that a few states began giving patients the same rights.

While a handful of physicians were vocal supporters of these early efforts, the majority of doctors were far less enthusiastic. They worried that their notes might become a source of unnecessary stress for patients. Read without an experienced clinician's interpretation, slight abnormalities like an elevated cell count from a viral infection could turn into a life-threatening cancer in the eyes of patients.

Even routine abbreviations and jargon like "S.O.B." (shortness of breath) and "anorexic" (a general lack of appetite, not the disease anorexia nervosa) could be confusing at best and inadvertently demeaning at worst. Doctors, already pressed for time, shuddered at the idea of suddenly being responsible for the worries of a reading public.

In 1996, despite these concerns, the Health Insurance Portability and Accountability Act, or HIPAA, gave all patients the legal right to read and even amend their own medical records. At the time, a group of national health care experts hailed this new transparency as a necessary component of better and safer care.

But today, few patients have ever laid eyes on their own records. And those who try often come back from their missions with tales of bureaucratic obstacles, ranging from exorbitant copying costs to diffident administrators. The same concerns from 40 years ago come up again and again, with little evidence to support or refute the claims of either side. Should medical records be shared as interactive documents between patients and physicians? Can transparency work, or will it end up worrying patients, muddling the patient-doctor relationship and adding more work to an already overburdened primary care work force?

Now, according to the latest issue of the Annals of Internal Medicine, the answers to these questions may finally be answered in a year's time.

This summer, researchers have begun the largest study to date of open access, aptly named Open Notes, involving over 100 primary care physicians and approximately 25,000 patients from three health care centers — the Beth Israel Deaconess Medical Center in Boston, the Geisinger Health System in Danville, Pa., and the Harborview Medical Center in Seattle. In the study, patients who have just seen their doctors will receive an e-mail message directing them to a secure Web site where they can view the signed physician notes. Patients will receive a second e-mail message two weeks prior to any return visit, reminding them that the notes from their previous visit are available for review.

Over the course of the yearlong study, funded by the Robert Wood Johnson Foundation, the Open Notes investigators hope to analyze the expectations and experiences of patients and physicians, as well as examine the number of additional phone calls, e-mail messages and visits that may arise as a result of more patients viewing their doctors' notes. In addition, a public survey on the journal's Web site will assess the opinions of any patient or doctor not enrolled in the study.

"We have one simple research question," said Dr. Tom Delbanco, a lead investigator who is a primary care physician at the Beth Israel Deaconess Medical Center. "After a year, will the patients and doctors still want to continue sharing notes?"

While enrolling patients in the study has not been difficult, finding physicians who are willing to participate has been more challenging. A few doctors were quick to sign on, but "most physicians were ambivalent at best," noted Jan Walker, a registered nurse and health services researcher at Beth Israel Deaconess who is the study's other lead investigator. Many physicians were worried about workload and issues of clarity.

"The note is really a story," said Dr. Sara B. Fazio, a primary care physician at Beth Israel Deaconess who hesitated at first but is now one of the participating doctors. "The meaning of a story depends on the storyteller. Just because I write something down as my version of the facts doesn't mean that they will be the absolute facts or that another person could not interpret those facts differently." While physicians recognize that such differences in interpretation occur frequently, particularly across different specialties, patients may not. "A doctor's note could come across in a very unexpected way to a patient even when the doctor wrote it with the best of intentions," Dr. Fazio said.

The researchers are hopeful that their study will help to settle many of the longstanding issues regarding open access, but one thing has already become apparent. For at least a few of those involved, the once sharply demarcated lines of the decades old tension have begun to fade. It is no longer so clear who exactly stands on what side of the medical records wall.

"In the end," Dr. Fazio said in an e-mail message, "we are all patients — if not now, then someday — and from that perspective it is easy to see the many reasons why this is a step in the right direction."

She added, "I suspect the physician in me will eventually be won over by that perspective given a little time."

Friday, July 23, 2010


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The Idealized Birth - Motherlode Blog -

There has been a lot of talk about childbirth in my in-box lately.

A reader, who signs her Motherlode comments "Jessa in Atlanta," raised the subject most recently, in an e-mail message that addressed what she calls her "mixed feelings about the ideal birth."

She had one, she said. At least she thought she had. "I did everything perfectly," she wrote. "Arrived at the hospital at 9 centimeters, checked in, avoided all interventions and pushed out a healthy 8 lb. baby with no medication, total labor and delivery time was about 8 hours, pushing was only 5 minutes." And yet, she continued, "even though I got exactly what I wanted, I have since felt very dubious about that birth." She had a different kind of birth experience with her first child, an "imperfect" birth, if you will, in that she used pain medication. "I actually have fonder memories of the epidural experience," she wrote, "it was so much more … dignified."

Her reason for writing was because "a friend just asked me to tell her which birth I would recommend, the epidural or the au natural." A drug-free birth, she said, "is wiser and safer … right?  That was what made me want to do it." And yet. "I've proven that it can be done, but still, the pain was so awful that I really just can't recommend it," she wrote. "I would do it again if I had to, because of the benefits, but I can't tell another woman to try it."

Is she the only one with this ambivalence, she wondered?

Her e-mail message led me to revisit two thought-provoking discussions of childbirth that have appeared on the parenting blog recently. They could not be more different.

Earlier this month, the site ran a series of five essays collectively titled "Not the Birth I Planned (and I Loved It)". There is one from a mom who "planned a natural … but I had to have my water broken and get pitocin," another who "planned a home birth … but had a C-section," and a third who "planned a hospital birth … but delivered at home." There's a woman who thought she would reject an epidural but asked for one, and her bookend, a woman who planned to ask for one, but never did.

So the moral of the story is any birth is a good birth if mother and baby are healthy, right? That's what I thought it should be. But a few weeks before this round-up, Babble also ran an essay by Denise Schipani, titled "Did I Really Need to Have a C-Section? The Problem With Doctors, not Moms, Picking the Birth Method."

The idea of childbirth as a sporting event with gold medals is apparently still alive and kicking, at least at Schipani's house.

I did not write about that essay when it first ran in May because it troubled me. It raises all the important questions about whether doctors are too quick to move to the operating room. But the underlying point is that she was deprived of a real birth, her idealized birth. There is a "right" way, she implies, and she did it wrong.

More ...

Time Filled With Doctors and Therapists - Motherlode Blog -

Kids get you up early – well, they can get you up at all hours to tell the truth. My son and daughter have brought me out of a sound sleep more often than I care to remember or will ever likely forget.

Not that I'm alone in this – we split shifts in our house. My wife, being a night owl, let's me get my sleep in early and I take the shift after 2 a.m. We formally instituted this schedule after my son was initially diagnosed with cerebral palsy. In those days it became clear that he wouldn't be sleeping through the night anytime soon.

It's a strange sensation, coming out of a deep sleep — jolted back into the waking world by a cry or a call or a sign of sickness or discomfort. At these times, I find my body is quicker to react than my mind. It's not unusual for me to be half way across the hall before I realize where I am or what I'm doing or recognize that I've passed out of a dream into the real world.

After the initial shock though, it can actually be a relief, waking up. I'll rest with the kids on my lap for a bit, patting their backs, waiting until they are calmed and then head down to the kitchen for a glass of water before heading back to my own bed.

"What was it?" my wife asked in a sleepy whisper on a recent night, "Is everything O.K.?"

"Nothing. I think the boy was just a little lonely. He's sleeping now," I said, and kept an ear cocked for any sound of a relapse.

"He's down," I said after a bit.

"He ought to be" she said with a yawn, "Today was a double therapy day."

It's times like these that I don't want to look at the digits on the clock; don't want to know how little time there is left in the night. Sometimes, I can go back to sleep, but more often now I'll just listen. There was a time in my life that my thoughts were mostly full of the future — or the past. Not now. The next day is always so close.

Most of our days are planned from end to end: school or camp for my daughter, work and errands for the grown ups and a battery of appointments for my son. It's a little like trying to get the kids into the dentist and the doctor on the same day every weekday in the year. There is precious little time in the daylight to think about anything but what has to be done.

Sometimes, even when I do sleep, it feels as if I've hardly closed my eyes when I just land slap into the morning light as if I had passed through one of those time warps in a sci-fi movie. Sometimes it feels as if entire days can go missing like this — when I'm so tired and disoriented that I don't remember what day it is or the season or my age or what I'm supposed be doing.

There's an old story I think of when I feel out of time like this; sometimes it's the last thought in my head before I drift off. It may sound a little like a children's story — I suppose it is (or very much like one for grown-ups). There's a very old line in English literature that tells of a little bird that flits out of a storm and into the shelter of a great open hall for a moment and then is gone again in the twinkle of an eye. I wonder sometimes how that bird got into the hall (somebody left a door open, I guess) or why he didn't stay.

The story reminds me very much of the tales I used to hear when I was a boy about bunnies or sheep or billy goats who seem to live in a world of their own logic. I forget for a moment that the author, with the very formal name of the Venerable Bede, had a much more serious intent for this image that I've paraphrased here. I just think of that little bird and it helps me understand my own quick, mysterious flights from waking to sleeping and then back again. The story helps me feel less worried about my own bewilderment and get some sleep before the kids wake me up again.

"Is today not a school day?" my daughter has begun to ask each morning when she get's up. "Do you go to work today?"

She hasn't quite got a full grasp on the basics of time yet. She'll sit on the edge of her bed while she rubs her eyes and try to puzzle out the weekdays from the weekend.

"What about the day after today?" she'll ask hopefully if it happens to be some other day than Saturday or Sunday or holiday.

"What about the day after that day?" she'll say if that answer fails too.

It's hard to look down at her little sleepy brown eyes and not want to chuck my whole Monday schedule. I know that as much as we try to prevent it, she's absorbing some of this overwhelming pace; that she knows there are days when things are just a little less crazy.

My son is more direct in his wishes.

"Park!" he says standing in his crib, "Park! Swing!"

His version of "swing" actually sounds more like "wing," but it doesn't make it any easier to say no to him, however gently. He's starting to walk now, and in addition to the swing, he loves to explore with his new skills.

He just looks at me as if I've not gotten the concept, like my wits are sleepy. He just goes on repeating his request cheerfully, like someone who goes on ringing a doorbell patiently — expecting that the porch light will click on eventually and someone will come out.

Some of this will sound like pretty ordinary morning family stress; we're all busy people these days. It's not easy to say what distinguishes our life now from what it might be without the cerebral palsy in our family. I talk with other parents, and outside of the frequency of our visits to the therapists and the doctors, much of our experience as parents is the same.

But I do know it's different. Some of these differences can be read through ordinary indicators like all the debits to doctors and therapists in our checkbook or the fact that I know many of our health-insurance representatives now on a first-name basis, but some are less easy to mark.

There's a feeling in our house that is similar to when a member of the family has a fever or an injury or an impending and worrisome visit to a specialist; that feeling that lifts all the emotional energy into something like a light fever; a feeling that translates into a thousand uncomfortable adjustments to ease the discomfort of the person who is affected. It's a feeling that has moved in with us for the foreseeable future.

"All right, family, let's get going," the day begins officially with one of us saying this.

The doorbell rings, the backpacks get slung, the keys get ferreted out from under whatever they've crawled under and we all put on our game faces. I watch my son begin his drills with one of the many friendly therapists who help him; we guide our daughter out the door and off to camp; we prepare for the sprint into the business of the day.

It's better when we're moving. The anxiety about the events of the day seems to lift slowly like fog burning off. It's not so bad; I know we're lucky in a lot of ways. We have means, we have friends and family, and I'm grateful.  And when I begin to focus on the first task of the day, whatever that may be, I think I understand that bird in the story a little better. I begin to understand why he doesn't stay in the temporary shelter; understand why he flits right back out. I think he's on his way, wherever that might be, and there's no reason just to hang around.

Thursday, July 22, 2010

New Guidelines Seek to Reduce Repeat Caesareans -

Most women who have had Caesarean sections can safely give birth the normal way later, studies have shown, but in recent years hospitals, doctors and insurers have been refusing to let them even try, insisting on repeat Caesareansinstead.

The decisions have been based largely on fears of medical risks and lawsuits, medical and legal experts say.

The hospital rules have infuriated many women, added to the nation's ever-increasing Caesarean rate and set off a bitter debate over who controls childbirth. Now, the American College of Obstetricians and Gynecologists is issuing a new set of medical guidelines meant to make it easier for women to find doctors and hospitals that will allow vaginal birth after Caesarean, or VBAC (pronounced vee-back).

Women's health advocates praised the new guidelines because they expand the pool of women considered eligible for vaginal births, but they expressed doubts about whether the recommendations go far enough to change a decade of entrenched behavior by doctors, hospitals and insurers.

The new guidelines replace the obstetrician group's earlier ones — which were exactly what led many hospitals to ban VBAC in the first place. But the group says it never intended to limit women's access to vaginal birth, and it acknowledges that its policies may have helped fuel the trend toward too many Caesareans.

"It will be better for women in the long run if we can lower the C-section rate," said Dr. Richard N. Waldman, president of the obstetricians' group and chairman of obstetrics at St Joseph's Hospital in Syracuse. The guidelines are being published on Thursday in the August issue of Obstetrics & Gynecology.

About 1.4 million women had Caesareans — or about 32 percent of all births — in 2007, the latest year with figures available, according to the National Center for Health Statistics. Like earlier guidelines, the new ones say that vaginal birth is safe for most women who have had a Caesarean, provided that the cut in the uterus was low and horizontal, the way nearly all Caesareans are performed today. Sixty to 80 percent of women who have what doctors call "a trial of labor" — an attempt to deliver vaginally — after a Caesarean succeed.

The new guidelines go beyond the earlier ones, however, stating that vaginal birth after Caesarean is also reasonable for most women carrying twins and those who had two prior Caesareans.

Even if a hospital does not offer trials of labor after Caesarean, the group says, "such a policy cannot be used to force women to have cesarean delivery or to deny care to women in labor who decline to have a repeat cesarean delivery."

The main worry is the risk of uterine rupture during labor, which can severely harm both the mother and the child and requires emergency surgery. But the guidelines state that for women with one previous Caesarean, the risk of rupture during a trial of labor is quite low — from 0.7 percent to 0.9 percent. If the same woman has a repeat Caesarean instead, before labor starts, the risk of rupture is even lower — from 0.4 to 0.5 percent.

But a Caesarean increases the risk of placental problems in later pregnancies that can cause hemorrhage or lead to hysterectomy.

Compared with babies born after a repeat Caesarean, those born vaginally after Caesarean have increased risks of stillbirth (the overall risk is well below 1 percent), but decreased risks of breathing problems and jaundice.

Until the 1970s, the rule was "once a Caesarean, always a Caesarean," largely because of worries about rupture. But medical opinion shifted, and an expert panel convened by the National Institutes of Health in 1980 found that vaginal birth after Caesarean was safe for many women.

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Wednesday, July 21, 2010

Prone to Error: Earliest Steps to Find Cancer -

Monica Long had expected a routine appointment. But here she was sitting in her new oncologist's office, and he was delivering deeply disturbing news.

Nearly a year earlier, in 2007, a pathologist at a small hospital in Cheboygan, Mich., had found the earliest stage of breast cancer from abiopsy. Extensive surgery followed, leaving Ms. Long's right breast missing a golf-ball-size chunk.

Now she was being told the pathologist had made a mistake. Her new doctor was certain she never had the disease, called ductal carcinoma in situ, or D.C.I.S. It had all been unnecessary — the surgery, the radiation, the drugs and, worst of all, the fear.

"Psychologically, it's horrible," Ms. Long said. "I never should have had to go through what I did."

Like most women, Ms. Long had regarded the breast biopsy as the gold standard, an infallible way to identify cancer. "I thought it was pretty cut and dried," said Ms. Long, who is a registered nurse.

As it turns out, diagnosing the earliest stage of breast cancer can be surprisingly difficult, prone to both outright error and case-by-case disagreement over whether a cluster of cells is benign or malignant, according to an examination of breast cancer cases by The New York Times.

Advances in mammography and other imaging technology over the past 30 years have meant that pathologists must render opinions on ever smaller breast lesions, some the size of a few grains of salt. Discerning the difference between some benign lesions and early stage breast cancer is a particularly challenging area of pathology, according to medical records and interviews with doctors and patients.

Diagnosing D.C.I.S. "is a 30-year history of confusion, differences of opinion and under- and overtreatment," said Dr. Shahla Masood, the head of pathology at the University of Florida College of Medicine in Jacksonville. "There are studies that show that diagnosing these borderline breast lesions occasionally comes down to the flip of a coin."

There is an increasing recognition of the problems, and the federal government is now financing a nationwide study of variations in breast pathology, based on concerns that 17 percent of D.C.I.S. cases identified by a commonly used needle biopsy may be misdiagnosed. Despite this, there are no mandated diagnostic standards or requirements that pathologists performing the work have any specialized expertise, meaning that the chances of getting an accurate diagnosis vary from hospital to hospital.

Dr. Linh Vi, the pathologist at Cheboygan Memorial Hospital who diagnosed D.C.I.S. in Ms. Long, was not board certified and has said he reads about 50 breast biopsies a year, far short of the experience that leading pathologists say is needed in dealing with the nuances of difficult breast cancer cases. In responding to a lawsuit brought by Ms. Long, Dr. Vi maintains that she had cancer and that two board-certified pathologists at a neighboring hospital concurred with his diagnosis.

Yet several leading experts who reviewed Ms. Long's case disagreed, with one saying flatly that her local pathologists "blew the diagnosis."

The questions that often surround D.C.I.S. diagnoses take on added significance when combined with criticism that it is both overdiagnosed and overtreated in the United States — concerns that helped fuel the recent controversy over the routine use of mammograms for women in their 40s.

The United States Preventive Services Task Force, an independent panel that issues guidelines on cancer screening, found last November that the downside of routine annual mammograms for younger women might offset the benefits of early detection. The panel specifically referred to overdiagnosis of D.C.I.S., as well as benign but atypical breast lesions that left undetected would never cause problems.

D.C.I.S., which is also called Stage 0 or noninvasive cancer, was a rare diagnosis before mammograms began to be widely used in the 1980s. Until then, breast pathology typically involved reading tissue from palpable lumps. The diagnoses — usually invasive cancer, a benign fibroid tumoror a cyst — were often obvious.

Today, D.C.I.S. is diagnosed in more than 50,000 women a year in this country alone. The abnormal cells, which are encased in breast ducts, are removed before they develop into invasive cancer. There are estimates that if left untreated, it will turn into invasive cancer 30 percent of the time, though it could take decades in some cases.

Concerned about the accuracy of breast pathology, the College of American Pathologists said it would start a voluntary certification program for pathologists who read breast tissue. Among its requirements is that the pathologists must read 250 breast cases a year.

"There's no question there's a problem, and that's why we're starting this certificate program," said Dr. James L. Connolly, director of anatomic pathology at Beth Israel Deaconess Medical Center in Boston.

While the program has not started yet, it is still controversial.

With hundreds of thousands of breast biopsies performed in this country a year, some pathologists stand to lose business, Dr. Connolly said, if doctors and patients demand that their slides go to a certified pathologist.

Cases like Ms. Long's may be extreme examples, but tracing her story shows why doctors increasingly say that a woman's initial reaction to a diagnosis of D.C.I.S. should be caution rather than a rush to disfiguring surgery or potentially harmful radiation.

Dr. Dennis Citrin, the oncologist at Midwestern Regional Medical Center in Zion, Ill., who told Ms. Long that she did not have D.C.I.S., said efforts to identify cancer at its earliest stages could benefit patients but also create problems.

"We're now trying to move the goal post if you like," Dr. Citrin said. "We're trying to make a diagnosis at an earlier and earlier stage. There are going to be patients where there's confusion or difference of opinion in this spectrum of changes, the earlier that you move in the process. So that's why there are cases like Monica's."

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Harvard puts tighter limits on medical faculty - The Boston Globe

Harvard Medical School will prohibit its 11,000 faculty from giving promotional talks for drug and medical device makers and accepting personal gifts, travel, or meals, under a new policy intended partly to guard against companies' use of Harvard's prestige to market their products.

The conflict-of-interest rules also place stricter limits on the income faculty can earn from companies for consulting, joining boards, and other work; require public reporting of payments of at least $5,000 on a medical school website; and promise more robust internal reporting and monitoring of these relationships.

Harvard, which provides continuing medical education for tens of thousands of doctors worldwide, also will erect a more solid firewall between itself and health care companies during these courses. The greatest impact will be on Pri-Med, an annual conference for primary care doctors at a Boston convention center, which features Harvard-taught courses. Pharmaceutical companies pay for separate breakfast, lunch, and dinner lectures by non-Harvard specialists and even market products in restrooms. The industry program will be moved to a more separate location, and marketing signs will no longer be allowed in bathrooms.

The new rules, which will be phased in after Jan. 1, are designed to keep doctors from becoming — or being perceived as — marketing agents for industry, said Dr. Robert Mayer, cochairman of the committee that wrote the new policy. "We're anxious to be viewed publicly as doing what's in the best interest of our patients,'' he said. The school wants to "ensure credibility even more than we do today.''

The group attempted to strike a careful balance, said Mayer and Dr. Jeffrey Flier, the medical school dean, reducing problematic conflicts while protecting collaboration between faculty and companies on research, because these relationships lead to important and life-saving treatments. Faculty still will be allowed to conduct industry-funded research and work as paid members of company scientific advisory boards.

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Monday, July 19, 2010

DIY medicine on YouTube: It’s not a how-to, people! - The Globe and Mail

Aaron Zube had already been to the emergency room once to treat his broken toes after he had dropped a 120-pound manhole cover on his right foot.

But one evening when the 25-year-old plumber from Hickory, N.C. was enjoying a KFC dinner, the pressure from the blood that was building up behind his big toenail became too much to bear. He couldn't imagine waiting an hour in emergency to have the nail removed, so he pushed aside his plate of fried chicken, macaroni and cheese and potato wedges to perform impromptu surgery with a pair of tweezers.

If you think that sounds gruesome, wait till you see the YouTube video.

Mr. Zube's is just one of a few dozen home toenail removal videos. There are also several that depict cyst excisions, abscess drainages and tattoo removals (the last done with power sanders and a hot spoon burning method). Most popular, though, are the unassisted home births.

Before, doctors worried about patients who self-diagnosed after doing Internet research on questionable medical websites. But the social Web has given birth to a new beast: users who document their DIY medical procedures on camera and share the videos on YouTube.

In Mr. Zube's case, he had a camera right beside him and thought he might as well get the gory procedure on tape.

Toronto media account executive Ryan Narhi, 37, was out of town when he needed surgical staples removed from his elbow (they were put in following a mountain biking injury) and after a few beers in his friend's backyard, decided to take them out.

In a YouTube video he posted that generated more than 8,000 views, he sits in a plastic patio chair while his friend pulls out each of the five staples with an instrument given to him by the doctor who put them in; Mr. Narhi had been told to take the tool to a walk-in clinic.

The first commenter on his video asks a simple question: "y wouldnt u have a doctor do that?"

"To me, it would have felt really silly going to a walk-in clinic to say, 'Could you remove these?' " Mr. Narhi says. "I felt I'd be wasting someone's time to take minutes out of his day to remove them."

Unlike Mr. Narhi, Doug Southern would have preferred to see a doctor, but bad timing meant he was without health insurance. He was laid off from his job a short while before a three-year-old baseball-sized cyst on his back became infected.

When his brother-in-law, a family practitioner, and his sister came to visit him in Tuscaloosa, Ala., he decided to put down a towel and pillow on his kitchen floor and turn it into a makeshift operating room so his cyst could be taken out "Alabama style."

The graphic, seven-minute YouTube video is punctuated with squeals of delight and revulsion from Mr. Southern's sister (the camerawoman) and commentary from the doctor ("Now you see how that's a little bit cheesy there? That's some of the cyst stuff comin' out.").

"I would never recommend anyone doing this at home," Mr. Southern, 41, says. "I obviously did it, but the situation I was in kind of allowed me the ability to have that done and it be controlled and somewhat safe."

His video was posted mostly for entertainment ("You don't want to see it, but once you see it happening, you can't take your eyes off it," he says) but it was uploaded to the "Education" category of YouTube.

That's where doctors say the problem lies if viewers see these videos as how-to guides.

Particularly troubling to Richard Musto, a public health physician with Alberta Health Services in Calgary, are the videos that depict unassisted home births, some of which have garnered millions of hits and several comments from expectant mothers eager to learn about the procedure.

Last month, a 14-year-old girl in Texas was charged in relation to the death of her newborn boy, whom she left in a dumpster. The baby died minutes after he was born and investigators suggest it may have been because the afterbirth blocked his airway. The girl and her younger sister learned how to deliver the baby at home after watching videos on YouTube.

"You can understand it's a natural thing, but things go wrong in childbirth and that's why you need to have someone that's properly trained to manage that," Dr. Musto says.

"Really, it's an extension of what the Web has done for medical care already. Part of the march of access of information," says Simon Kingsley, the acting chief of the department of emergency medicine at St. Michael's Hospital in Toronto.

He's seen the aftermath of DIY medicine in the emergency room: People drain their own boils with sewing needles and contract infections, others remove their own casts early "and get a non-union of a bone in their wrist that will hurt them every day for the rest of their lives."

"I get patients asking me a lot, 'Can I take these sutures out myself?' If you take them out the wrong way you're left with a chunk of nylon under your skin that can cause infection," he says.

Mr. Zube got through his at-home toenail removal with a lot of blood, but no infections. He sterilized the tweezers before he used them by boiling them and soaking them in alcohol. He dressed his wound after with sterile gauze.

While certain procedures may seem foolproof, Dr. Kingsley still says patients should see doctors or nurses for them just for the one-in-10 chance that things go wrong. Looking up a video of an abscess drainage or a toenail removal performed by a doctor may be helpful to prepare a patient for that same procedure, he says, "But doing it? That's just crazy."