Jumat, 01 Maret 2013

Well: Think Like a Doctor: The Wobble Solved!

Well: Think Like a Doctor: The Wobble Solved!

On Thursday, we challenged Well readers to solve the mystery of a 56-year-old man who suddenly became too dizzy to walk. More than 400 readers wrote in with their take on this patient’s problem. I was amazed by how many of you were on the right track. At least 30 readers figured it out â€" with the first right answer coming in just a half hour after the case was posted.

The correct diagnosis is…

Vitamin B12 Deficiency

The first right answer came from Tierney Wisniewski, a writer in Vancouver, Canada. She had been reading up on Vitamin B12 on her own and recognized some of the symptoms. She is an avid puzzle solver and has participated in previous “Think Like a Doctor” cases, but this is the first ti me she made the right diagnosis. She is also the first completely nonmedical professional to win the contest. I knew you could do it!

The Diagnosis:

Vitamin B12 is necessary for every cell in the body, but a deficit of the vitamin usually shows up first in nerve cells or in red blood cells, or sometimes both. It is one of the most common nutritional deficiencies seen in the United States, but it is usually not caused by a lack of B12 in the diet. The vitamin is found naturally in eggs, milk and meat and is added to some cereals. While vegans who don’t eat these animal products are at risk for B12 deficiency, most people get plenty of B12 in their diets. However, for people with B12 deficiency, the issue typically is not a lack of B12 in the diet; it is a problem with absorbing the nutrient once it is in the body. The machinery for absorbing B12 is complicated, and most people who have B12 deficiency have some problem with this organic equipment.

Absorption of vitamin B12 starts in the stomach, where acidic fluid frees up the vitamin, and a second digestive chemical known as intrinsic factor carries the vitamin to the small intestine, where it is taken up and put to work. In some people, chronic infection with a type of bacteria that has been linked to ulcer formation, Helicobacter pylori, can interfere with the stomach’s production of these essential chemicals and prevent absorption. In others, the immune system goes after the absorption machinery, leading to vitamin B12 deficiency. Other populations at risk for vitamin B12 deficiency are people who have some kind of abnormality in their small intestines that prevent vitamin absorption, including those with Crohn’s or celiac disease, following gastric bypass surgery, those who take certain medications to treat acid reflux or diabetes, and those with chronic alcoholism.

No matter where the machinery breaks down, high doses of the vitamin can overcome it. Patients can flood their systems with B12 and, in most cases, all the problems caused by the deficiency will be reversed.

How the Diagnosis Was Made:

Most of the time, doctors in the hospital see patients lying in bed. When they are better, we might see them sitting in a chair. But having a patient walk â€" although part of the physical exam taught to every medical student â€" is not something we usually ask of hospitalized patients. Sometimes they are too sick to get up. Often it is not pertinent to what the patient came in with. In this case it was more than pertinent â€" it was essential.

Over the course of his two hospital admissions, the p atient told several doctors that he was too dizzy to walk. When Dr. Robert Centor heard that, he immediately wanted to see what happened when he tried.

Once the patient stood up, Dr. Centor noticed that he planted his feet wider apart than normal, reflecting the patient’s own sense that he was unstable. He then asked the patient to shut his eyes. Balance is controlled by three systems: our eyes help us see where we are in relation to the world around us; our inner ear helps us know where our head is in space; and the nerve endings in the joints of our feet supply us with a sense of where our bodies are with respect to the floor. You need two out of three systems working to keep standing. The fact that this man wobbled and nearly fell when he shut his eyes showed that something in his balancing machinery wasn’t working.

Having the patient stand with his eyes closed is called the Romberg test. It was developed based on the observations made in the mid-19th cent ury by German physician Dr. Moritz Heinrich Romberg, who was caring for patients with advanced syphilis. This is how Romberg described what he saw: “The gait begins to be insecure, he puts down his feet with greater force…. If he is ordered to close his eyes while in the erect posture, he at once commences to totter and swing from side to side; the insecurity of his gait also exhibits itself more in the dark.”

Although this characteristic gait can be seen in late-stage syphilis, we now know that it can be seen in other diseases as well. Many of these diseases were mentioned by Well readers who wrote in with their suggested diagnoses for this wobbly patient.

Dr. Centor then noted that the patient walked with a slapping gait, which results from the same problem that caused him to wobble, suggesting he was unsure exactly where the floor was. At that point, Dr. Centor recognized that this was clearly a problem with the nerves. He ordered an M.R.I. of the brain, nerve conduction studies to see if the problem was with the nerves in his feet or those in his brain, and a test of vitamin B12 levels. A test for syphilis had already been ordered. When the vitamin B12 level came back very low, the patient was started on high doses of the vitamin. That was four months ago.

I spoke to the patient recently and he says he is feeling a whole lot better. He is not wobbling any more, and he is planning to go back to work very soon.

A Missed Diagnosis:

This patient made his second hospital visit less than two weeks after his first. That is not unusual these days. A recent study suggested that one in five older patients are readmitted to the hospital within 30 days of discharge. One in five! While many of those patients come back to the hospi tal with a different problem than the one they were originally admitted for, it has been shown that most of these re-admissions can be avoided with careful planning and coordination when the patient is discharged from the hospital the first time. One of the key components is scheduling a follow-up visit to the patient’s doctor within a week of discharge.

Dr. Centor told me that he was sure that if this patient had gone to see his regular doctor after he had left the hospital, he wouldn’t have had to come back. “We rarely see patients walk in the hospital. But if this man had walked into his doctor’s office, I have no doubt his strange walk would have been picked up right away.”

Starting last fall, Medicare started penalizing hospitals for patients who have a second admission within 30 days of discharge. The hope is that by encouraging hospitals to set up care for their patients during the vulnerable period after they come home â€" while recovering from what one smart researcher calls their “post-hospital syndrome” â€" they will improve care, reduce costs and lessen patient suffering.

However, the patient has no regrets about going back to the hospital. “I’m just glad they figured it out. I’m too young to be that old.”

Cancer risk from Fukushima disaster small, report says

Cancer risk from Fukushima disaster small, report says

The 9.0-magnitude Tohoku-Oki earthquake and resulting tsunami that triggered a meltdown at Japan's Fukushima Daiichi Nuclear Power Station has resulted in only a small increase in lifetime cancer risks for people living nearby, and an even smaller risk for populations outside of Japan, according to a new report from the World Health Organization.

The uptick in disease resulting from radiation released by the crippled plant is "likely to remain below detectable levels," the study authors concluded in their 166-page report released Thursday. That added risk will probably be drowned out by the choices people make throughout their lives, such as whether to smoke and how much to exercise, they said.

Based on the estimated levels of radiation released into the environment during the Fukushima crisis two years ago, scientists determined that the greatest threat people would probably face would be an increased risk of cancer. The most vulnerable people were infants who lived in close proximity to the plant on Japan's eastern coast.

For instance, baby boys who lived in the area at the time now have a 7% increased risk of developing leukemia during their lifetimes compared with what they would have faced if the meltdown hadn't happened. Baby girls who lived near the plant and were exposed to radiation now have a 6% increased risk of developing breast cancer and a 4% increased risk of developing any type of cancer that forms solid tumors.

The study authors also calculated that these girls are now 70% more likely to develop thyroid cancer, but they emphasized that the absolute risk was still very small, rising from 0.75% to 1.25%.

Although emergency workers had some of the highest levels of radiation exposure, they had yet to demonstrate acute radiation effects, the scientists found. The only effects that are expected in this group are "possible thyroid disorders in those few workers who inhaled significant quantities of radioactive iodine," the authors wrote.

Six Fukushima plant workers died during or soon after the March 2011 disaster. A United Nations report last year determined that none of them perished due to the effects of radiation and attributed their deaths and injuries to physical trauma, cardiovascular stress and heat stress. One reported leukemia death could not be attributed to the meltdown because of the short time between radiation exposure and death, the U.N. said.

The report said exposure levels were insufficient to cause an increase in miscarriages, stillbirths or birth defects. The report did not assess potential psychosocial or mental health impacts from the disaster.

No discernible increase in health risks was expected outside of Japan, the scientists concluded.

Much of the data that were used to develop the risk forecast model were taken from survivors of the Hiroshima and Nagasaki atomic bomb blasts and from the Chernobyl nuclear plant disaster.

The study authors said they took pains not to underestimate potential health risks from the Fukushima disaster. As such, they assumed that people living nearby the power plant took longer to evacuate than they actually did, and that they ate only food produced in the area.

Edwin Lyman, a nuclear physicist with the Union of Concerned Scientists, a watchdog group, said the WHO report's focus on the increased risk to each person "tends to dilute the impact" of the disaster.

Lyman pointed to another study done last year by Stanford University scientists who estimated that the meltdown would cause about 310 cases of cancer, including about 130 deaths. That study was published in the journal Energy Environmental Science.

monte.morin@latimes.com

Times staff writer Emily Alpert contributed to this report.

Well: A Rainbow of Root Vegetables

Well: A Rainbow of Root Vegetables

This week’s Recipes for Health is as much a treat for the eyes as the palate. Colorful root vegetables from bright orange carrots and red scallions to purple and yellow potatoes and pale green leeks will add color and flavor to your table.

Since root vegetables and tubers keep well and can be cooked up into something delicious even after they have begun to go limp in the refrigerator, this week’s Recipes for Health should be useful. Root vegetables, tubers (potatoes and sweet potatoes, which are called yams by most vendors â€" I mean the ones with dark orange flesh), winter squash and cabbages are the only local vegetables available during the winter months in colder regions, so these recipes will be timely for many readers.

Roasting is a good place to begin with most root vegetables. They sweeten as they caramelize in a hot oven. I roasted baby carrots and thick red s callions (they may have been baby onions; I didn’t get the information from the farmer, I just bought them because they were lush and pretty) together and seasoned them with fresh thyme leaves, then sprinkled them with chopped toasted hazelnuts. I also roasted a medley of potatoes, including sweet potatoes, after tossing them with olive oil and sage, and got a wonderful range of colors, textures and tastes ranging from sweet to savory.

Sweet winter vegetables also pair well with spicy seasonings. I like to combine sweet potatoes and chipotle peppers, and this time in a hearty lentil stew that we enjoyed all week.

Here are five colorful and delicious dishes made with root vegetables.

Spicy Lentil and Sweet Potato Stew With Chipotles: The combination of sweet potatoes and spicy chipotles with savory lentils is a winner.


Roasted Carrots and Scallions With Thyme and Hazelnuts: Toasted hazelnuts add a crunchy texture and nutty finish to this dish.


Carrot Wraps: A vegetarian sandwich that satisfies like a full meal.


Rainbow Potato Roast: A multicolored mix that can be vegan, or not.


Leek Quiche: A lighter version of a Flemish classic.


The New Old Age Blog: Why Can’t I Live With People Like Me?

The New Old Age Blog: Why Can’t I Live With People Like Me?

“Aging in place” is the mantra of long-term care. Whether looking at reams of survey data, talking to friends or wishing on a star, who among us wouldn’t rather spend the final years â€" golden or less so â€" at home, surrounded by our cherished possessions, in our own bed, no cranky old coot as a roommate, no institutional smells or sounds, no lukewarm meals on a schedule of someone else’s making?

That works best, experts tell us, in dense cities, where we can hail a cab at curbside, call the superintendent when something breaks and have our food delivered from Fresh Direct or countless takeout restaurants. We’d have neighbors in the apartment above us, below us, just on the other side of the wall. Hearing their toilets flush and their children ride tricycles on uncarpeted floors is a small inconvenience compared to the security of knowing they are so close by in an eme rgency.

Urban planners, mindful that most Americans live in sprawling, car-reliant suburbs, are designing more elder-friendly, walkable communities, far from “real” cities. Houses and apartments are built around village greens, with pockets of commerce instead of distant strip malls. Some have community centers for congregate meals and activities; others share gardens, where people can get their hands in the warm spring dirt long after they can push a lawn mower.

All of this is a step in the right direction, despite the Potemkin-village look of so many of them. But it doesn’t take into account those who are too infirm to stay at home, even in cities or more manageable suburban environments. Some are alone, others with a loving spouse who by comparison is “well” but may not be for long, given the rigors of care-taking. It doesn’t take into account people who can’t afford a home health aide, who don’t qualify for a visiting nurse, who have no adult children to help them or whose children live far away.

But by now, aging in place, unrealistic for some, scary or unsafe for others and potentially very isolating, has become so entrenched as the right way to live out one’s life that not being able to pull it off seems a failure, yet another defeat at a time when defeats are all too plentiful. Are we making people feel guilty if they can’t stay at home, or don’t want to? Are we discouraging an array of other solutions by investing so much, program-wise and emotionally, in this sine qua non?

Regular readers of The New Old Age know that I am single, childless and terrified of falling off a ladder while replacing a light bulb, breaking a hip and lying on the floor, unattended, until my dog wails so loudly a neighbor comes by to complain. A MedicAlert pendant is not something that appeals to me at 65, but even if I give in to that, say at 75, I’m not sure my life will be richer for digging my heels in and insisting home is where I should be.

So I spend a lot of time thinking about the alternatives. I know enough to distinguish between naturally-occurring-retirement communities, or NORCs (some of which work better than others); age-restricted housing complexes (with no services); assisted living (which works fine when you don’t really need it and not so fine when you do); and continuing care retirement communities (which require big upfront payments and extensive due diligence to be sure the place doesn’t go belly up after you get there).

What I find so unappealing about all these choices is that each means growing old among people with whom I share no h istory. In these congregate settings, for the most part, people are guaranteed only two things in common: age and infirmity. Which brings us to what is known in the trade as “affinity” or “niche” communities,” long studied by Andrew J. Carle at the College of Health and Human Services at George Mason University in Fairfax, Va.

Mr. Carle, who trains future administrators of senior housing complexes, was a media darling a few years back, before the recession, with the first baby boomers approaching 65 and niche communities that included services for the elderly â€" not merely warm-weather developments adjacent to golf courses â€" expected to explode. In newspaper interviews as recently as 2011, Mr. Carle said there were “about 100 of them in existence or on the drawing board,” not counting the large number of military old-age communities.

Mr. Carle still believes that better economic times, when they come, will reinvigorate this sector of senior housing, after the failure of some in the planning stages and others in operation. In an e-mail exchange, Mr. Carle said there were now about 70 in operation, with perhaps 50 of those that he has defined as University Based Retirement Communities, adjacent to campuses and popular with alumni, as well as non-alumni, who enjoy proximity to the intellectual and athletic activities. Among the most popular are those near Dartmouth, Oberlin, the University of Alabama, Penn State, Notre Dame, Stanford and Cornell.

At the height of the “affinity” boom, L.G.B.T.-assisted living communities and nursing homes were all the rage, seen as a solution to the shoddy treatment that those of different sexual orientations in the pre-Stonewall generation experienced in generic facilities. A few failed, most never got built and, by all accounts, the only one to survive is the pricy Rainbow Vision community in Sante Fe, N.M.

A handful of nudist elder communities, and ones for old hippies, also fell by the wayside, perhaps too free-spirited for the task. According to Mr. Carle, despite the odds, at least one group of RV enthusiasts has added an assisted-living component to what began as collections of transient elderly, looking only for a parking spot and necessary water and power hook-ups for their trailers. Native Americans have made a go of an assisted-living community in Montana, and Asians have done the same in Northern California.

But professional affinity communities, which I find most appealing, are few and far between.

The storied Motion Picture & Television Country House and Hospital, a sliding-scale institution in the San Fernando Valley since 1940, survived near-closure in 2009 as a result of litigation, activism by the Screen Actors Guild and the local chapter of the Teamsters, and news media pressure. Among film legends who died there â€" along with cameramen, back-lot security guards and extras â€" were Mary Astor, Joel McCrea, Yvonne De Carlo and Stepin Fetchit.

New York State’s volunteer firefighters are all welcome to a refurbished facility in the Catskill region that offers far more in the way of care and activities, including a state-of-the-art gym, than when I visited there five years ago. At that time, the residents amused themselves by activating the fire alarm to summon the local hook and ladder company, which didn’t mind a bit.

Then there is Nalcrest, the retirement home for unionized letter carriers. Even as post offices nationwide are preparing to eliminate Saturday service, and snail mail becomes an artifact, the National Association of Letter Carriers holds monthly fees around the $ 500 mark, is located in central Florida so its members no longer have to brave rain and sleet to complete their appointed rounds, and bans dogs, the bane of their existence.

So why not aged journalists? We surely have war stories to embroider as we rock on the porch. Perhaps a mimeograph machine to produce an old-fashioned, dead-tree newspaper, which some of us will miss once it has given way to Web sites like this one. Pneumatic tubes, one colleague suggested, to whisk our belongings upstairs when we can no longer carry them. Other colleagues wondered about welcoming both editors and reporters. How can these two groups, which some consider natural adversaries, complain about e ach others’ tin ears or missed deadlines if we’re not segregated?

I disagree. The joy of this profession is its collaboration. We did the impossible day after day when young. We belong together when old.


Selasa, 26 Februari 2013

Mediterranean diet shows key benefits, study finds

Mediterranean diet shows key benefits, study finds

Finally, there’s hard evidence that a Mediterranean diet can prevent heart disease.

Shunning red meats and processed food in favor of fresh fruits, vegetables, fish, nuts, olive oil, and even some wine can reduce heart attacks, strokes, and deaths from heart problems, according to the first study to demonstrate the diet’s benefits using the most reliable type of clinical trial.

Rachel Johnson, head of the American Heart Association’s nutrition committee, welcomed the findings. “We have moved away from the low-fat-at-all-cost message. It’s important to include these healthy fats in a diet,” such as olive oils and nuts.

Spanish researchers tracked thousands of participants over roughly five years and found a 30 percent reduction in the rate of heart disease, primarily strokes, among the Mediterranean diet eaters compared with people who consumed more traditional low-fat fare. That diet included more starch and grains, but fewer nuts and oils.

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Earlier studies had concluded there probably were benefits from a Mediterranean diet, but they weren’t definitive because of the design of the studies, including their reliance on participants’ recall of meals. Health and nutrition specialists who reviewed the latest study, published online Monday by the New England Journal of Medicine, said its size, controlled structure, and focus on patients who were at risk of heart disease offered powerful and much-needed evidence of a protective heart effect from a Mediterranean diet.

Dr. Ramon Estruch, a senior consultant at the Hospital Clinic of Barcelona who led the Spanish team, said the findings should give physicians confidence to urge patients, particularly those who are overweight or have diabetes or other risk factors for heart disease, to follow a Mediterranean approach.

“As a doctor it is easier to say take a pill,” Estruch said. “But diet is a very powerful effect in protecting against cardiovascular disease.”

Estruch’s team enrolled 7,447 people, ages 55 to 80, and then randomly assigned them to one of three groups: one that was directed to eat a Mediterranean diet that included at least 4 tablespoons a day of extra-virgin olive oil; another that also followed the Mediterranean diet and received roughly 1 additional ounce daily of a mixture of walnuts, hazelnuts, and almonds; and a third control group that was counseled to eat a low-fat diet that did not include olive oil or nuts. The olive oil included amounts used in cooking, poured on salads, and eaten in meals outside home.

All of the participants had diabetes or at least three major risk factors for heart disease, such as obesity, high blood pressure, elevated levels of bad cholesterol, or a family history of early heart disease.

Drug treatment regimens, such as medications to lower high blood pressure or cholesterol, were similar for those in all three groups.

Participants were asked annually to complete questionnaires about their health, leisure-time activities, and their diet. Scientists also tracked participants’ weight, height, and waistline measurements, in addition to testing the urine and blood of those receiving the extra-virgin olive oil and nuts to confirm compliance with the diet. No restrictions were placed on how much food any of the groups could consume.

After approximately five years, scientists counted 109 heart attacks, strokes, or deaths from heart disease in the control group, which did not eat the Mediterranean diet. By comparison, there were 83 in the Mediterranean group that ate extra nuts, and 96 in the Mediterranean group that consumed additional olive oil.

Scientists said that means that for every 1,000 people who followed the Mediterranean diet, three people each year would avoid a heart attack or stroke because of the diet.

“Even the best available drugs, like statins, reduce heart disease by about 25 percent, which is in the same ballpark as the Mediterranean diet,” said Dr. Walter Willett, professor of epidemiology and nutrition at the Harvard School of Public Health. “But the statins increase the risk of diabetes, whereas this diet can help reduce the risk.”

This study, which focused on people at high risk for heart disease, was not designed to measure whether a Mediterranean diet also protects the hearts of healthy individuals. But Willett said that based on what scientists know about cardiovascular disease, the same diet would be beneficial in healthier people.

The Spanish researchers said their findings may have been more dramatic if they compared the Mediterranean diet with more Western fare. They said most people in Spain typically eat a version of the Mediterranean diet, so the control group’s diet didn’t differ much from the Mediterranean diet, likely muting the study results. “The differences probably would be huge” if the comparison group ate a typical American diet, said Dr. Miguel Angel Martinez-Gonzalez, a study co-author and chairman of the Department of Preventive Medicine at the University of Navarra.

Getting American patients to adhere to a Mediterranean diet long term can sometimes be challenging.

Jack Bishop, editorial director at America’s Test Kitchen, a Brookline-based company that produces the popular TV show of the same name and Cooks Illustrated magazine, said a Mediterranean diet is easier to maintain than ones that require super low-fat intake.

“I am encouraged by this study,” Bishop said. “There are so many studies that leave you aloft as to what you are supposed to do, but this one is fairly clear, and the message seems doable and satisfying at the same time.”.

One unanswered question involves the type of extra-virgin olive oil used in the study. The scientists noted that they supplied a type of Spanish oil to participants that had a high level of polyphenols, a naturally occurring anti-oxidant found in fresh fruits and vegetables that is believed to have heart healthy benefits. Typical refined olive oils have much less of this substance.

Johnson, the head of the American Heart Association’s nutrition committee and a nutrition professor at the University of Vermont, said the findings demonstrate that the dietary advice offered by the association and other health groups is on the right track.

Senin, 25 Februari 2013

Former surgeon general C. Everett Koop dead at age 96

Former surgeon general C. Everett Koop dead at age 96

Koop was surgeon general from 1981 to 1989.

C. Everett Koop, the former surgeon general who brought frank talk about AIDS into American homes, has died at his home in Hanover, N.H., officials at the Geisel School of Medicine at Dartmouth announced Monday. He was 96.

Koop, a pediatric surgeon with a conservative reputation and a distinctive beard, was surgeon general from 1981 to 1989 during the Reagan administration and the early months of the administration of George H.W. Bush.

"Dr. Koop will be remembered for his colossal contributions to the health and well-being of patients and communities in the U.S. and around the world," said a statement released by Chip Souba, dean of the Geisel School of Medicine and Joseph O'Donnell, senior scholar at the C. Everett Koop Institute. "As one of our country's greatest surgeons general, he effectively promoted health and the prevention of disease, thereby improving millions of lives in our nation and across the globe."

He is best remembered for his official 1986 report on AIDS â€" a plain-spoken 36-page document that talked about the way AIDS spread (through sex, needles and blood), the ways it did not spread (through casual contact in homes, schools and workplaces) and how people could protect themselves.

The report advocated condom use for the sexually active and sex education for schoolchildren, pleasantly surprising liberals and upsetting many of Koop's former supporters. An ei ght-page version was mailed to every American household in 1988.

The brochure came in a sealed packet with the warning that "some of the issues involved in this brochure may not be things you are used to discussing openly."

In interviews and speeches, Koop always stressed that sexual abstinence and monogamy were the best protection against AIDS, but that medical experts had a duty to tell people who did not choose those paths how they could stay healthy.

"My position on AIDS was dictated by scientific integrity and Christian compassion," Koop wrote in his 1991 biography, Koop: The Memoirs of America's Family Doctor.

Koop also made his mark in the fight against smoking, with another 1986 report that alerted the public to the dangers of second-hand smoke â€" setting the stage for today's widespread prohibitions against smoking in public places.

At one point, Koop was the second-most recognized public official in the United States, after Pr esident Reagan, says Alexandra Lord, a former Public Health Service historian and author of "Condom Nation: The US Government's Sex Education Campaign from World War I to the Internet." He was one of the most high-profile surgeons general, before or since, she says -- though she says people under age 35 or so may not know his name today.

Charles Everett Koop was born in Brooklyn on Oct. 14, 1916. He briefly played football at Dartmouth College, where he acquired his lifelong nickname Chick, according to a biography posted online by the National Library of Medicine. An early fascination with medicine eventually led him to Cornell University Medical College. In 1945, he became first surgeon in chief at Children's Hospital of Philadelphia, a position he held until his appointment as surgeon general.

His nomination for that position was opposed by groups who feared he would use the office to promote his anti-abortion views â€" which he said were developed during a c areer saving newborns with life-threatening birth defects. But Koop avoided pronouncements on abortion during his tenure.

After he left office, he became one of the first high-profile doctors to establish a presence online. His website, DrKoop.com, was launched in 1997 and was intended to provide reliable health information to the public, he said. But Koop and his backers faced criticism over ties with companies advertising on the site. Like many Internet efforts of the era, it failed, going bankrupt in 2001.

Koop remained active, though, heading his C. Everett Koop Institute at Dartmouth in New Hampshire. At a news conference in Washington, D.C., in 2010, when he was 94, he spoke from a wheelchair and told reporters that he was "very, very deaf" and legally blind, the Washington Post reported.

But he still had the strength to warn that AIDS was becoming a "forgotten epidemic." Although 56,000 Americans were still getting infected each year, "simply put, HIV is no longer on the public's radar screen," he said.

Jumat, 22 Februari 2013

FDA approves Roche drug for late-stage breast cancer

FDA approves Roche drug for late-stage breast cancer

Fri Feb 22, 2013 12:30pm EST

(Reuters) - U.S. health regulators approved a new drug made by Swiss drugmaker Roche Holding AG for some patients with late-stage metastatic breast cancer who fail to respond to other therapies.

The U.S. Food and Drug Administration said on Friday it had approved Kadcyla, also known as ado-trastuzumab emtansine, for patients whose cancer cells contain increased amounts of a protein known as HER2.

The drug's label will carry a boxed warning, the most serious possible, of the drug's potential to cause liver and heart damage or even death. The drug can also cause life-threatening birth defects.

In clinical trials, patients who took the drug, known during its development process as T-DM1, survived an average of 30.9 months, compared with 25.1 months in a control group.

Analysts at Jefferies have estimated the drug could generate annual peak sales of $1.9 billion as usage in different settings increases. The drug will be priced at $9,800 a month.

"We don't expect to see significant payer pushback on pricing at launch, given the drug's efficacy and safety," said Simos Simeoni dis, an analyst at Cowen and Company, in a research note.

Kadcyla works by attaching trastuzumab, sold under the brand name Herceptin, to a drug called DM1, developed by ImmunoGen Inc, which interferes with cancer cell growth.

"Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival," said Dr Richard Pazdur, director of the FDA's office of hematology and oncology products. "It is the fourth approved drug that targets the HER2 protein."

Other drugs approved for the disease include Herceptin in 1998, lapatinib, made by GlaxoSmithKline Plc and sold under the brand name Tykerb in 2007, and pertuzumab, marketed as Perjeta and also made by Roche, in 2012.

The approval triggers a $10.5 million payment to ImmunoGen and sets the stage for the company to receive royalties of between 3 and 5 percent, depending on sales. The 5 percent level is triggered whe n sales top $700 million in the United States. The company also receives 5 percent when sales top $700 million elsewhere in the world.

Kadcyla is the first drug in its class, known as antibody-drug conjugates, or "armed antibodies" to be approved to treat a solid tumor. These drugs combine an antibody, Herceptin in the case of Kadcyla, with a killer toxin, in this case ImmunoGen's DM1, and links them together to deliver a highly potent bomb to the diseased cells.

The drugs seek out specific cells that express proteins associated with the cancer, while leaving other cells alone.

Breast cancer is the second-leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with the disease in 2013, and 39,620 will die from it, according to the National Cancer Institute. About 20 percent of breast cancer patients have increased amounts of the HER2 protein.

The most common si de effects in patients treated with Kadcyla were nausea, fatigue, muscle and joint pain, increased liver enzymes, headache and constipation.

Shares of ImmunoGen were up 2.6 percent at $14.67 in midday trading on the Nasdaq. Roche's shares were up 1.5 percent at 212 Swiss francs.

(Reporting by Toni Clarke in Washington; editing by Gerald E. McCormick, John Wallace and Matthew Lewis)