Saturday, December 18, 2010

Of Medicines and Mismeasurements -

Giving the correct dose of an over-the-counter pediatric medicine is critical, but the package labeling and dosing information can be virtually incomprehensible. And an overdose can be deadly.

Over the year that ended on Nov. 1, 2009, researchers examined the directions and measuring devices in 200 nonprescription pediatric liquid medicines — drugs for allergy, cough and cold, pain or gastrointestinal problems, and medicines in combination products.

Writing online on Nov. 30 in The Journal of the American Medical Association, the researchers report that 52 of the medicines had no measuring device in the package, and that 146 of the other 148 had inconsistencies between the dosing directions and the devices, including missing or superfluous markings, unfamiliar units of measurement (for example, drams or cubic centimeters), or undefined or nonstandard abbreviations.

In November 2009, the Food and Drug Administration published voluntary guidelines for the labeling of dosing directions and measuring devices for over-the-counter liquid medicines. "The plan is that we can expect to see changes by next winter," said Dr. H. Shonna Yin, the lead author.

But Dr. Yin, an assistant professor of pediatrics at New York University, is not finished. "When we do the study again," she said, "we'll see if voluntary guidelines work, or if we need something stronger." In the meantime, she said, parents should pay careful attention to both directions on packages and the labeling on measuring devices. "A tablespoon," she warned, "is three times as large as a teaspoon."

Empathy 101 -

The first time Jessamyn Conell-Price met Moira Nichols, they had a lively lunch with several of Mrs. Nichols's friends, all of whom volunteer at the community library. Then the two women chatted a bit in Mrs. Nichols's apartment and took a stroll around the neighborhood.

They talked easily about books and politics and life in the San Francisco Bay Area. Mrs. Nichols wondered if her new acquaintance spelled her first name the same way as the novelist Jessamyn West, and was delighted to learn that she'd actually been named in her honor. They agreed to meet every few weeks, "just to have a cup of tea and talk," Mrs. Nichols said.

Such a small thing. Or maybe not so small. Ms. Conell-Price, 26, is a first-year student in the University of California, Berkeley — University of California, San Francisco Joint Medical Program. Like many young people in an age-segregated culture, she barely knows anyone older than 60 except her own grandparents.

Mrs. Nichols, who's 89 and a longtime resident of Piedmont Gardens, a retirement community in Oakland, Calif., describes herself as a fan of inclusion. "I really like knowing and being friends with people of all ages," she told me. So she had signed on for the elder-mentor program offered by the universities, which matches new medical students with independent seniors.

By the end of the three-year program, involving 16 incoming students each year, "they will have some insight into what it's like growing old," Mrs. Nichols said. "I think that will be very useful to them."

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Early Alzheimer’s Detection, but When to Tell the Patient? -

Marjie Popkin thought she had chemo brain, that fuzzy-headed forgetful state that she figured was a result of her treatment for ovarian cancer. She was not thinking clearly — having trouble with numbers, forgetting things she had just heard.

One doctor after another dismissed her complaints. Until recently, since she was, at age 62, functioning well and having no trouble taking care of herself, that might have been the end of her quest for an explanation.

Last year, though, Ms. Popkin, still troubled by what was happening to her mind, went to Dr. Michael Rafii, a neurologist at the University of California, San Diego, who not only gave her a thorough neurological examination but administered new tests, like an M.R.I. that assesses the volume of key brain areas and a spinal tap.

Then he told her there was something wrong. And it was not chemo brain. It most likely was Alzheimer's disease. Although she seemed to be in the very early stages, all the indicators pointed in that direction.

Until recently, the image of Alzheimer's was the clearly demented person with the sometimes vacant stare, unable to follow a conversation or remember a promise to meet a friend for lunch.

Ms. Popkin is nothing like that. To a casual observer, the articulate and groomed Ms. Popkin seems perfectly fine. She is in the vanguard of a new generation of Alzheimer's patients, given a diagnosis after tests found signs of the disease years before actual dementia sets in.

But the new diagnostic tests are leading to a moral dilemma. Since there is no treatment for Alzheimer's, is it a good thing to tell people, years earlier, that they have this progressive degenerative brain disease or have a good chance of getting it?

"I am grappling with that issue," Dr. Rafii said. "I give them the diagnosis — we are getting pretty good at diagnosis now. But it's challenging because what do we do then?"

It is a quandary that is emblematic of major changes in the practice of medicine, affecting not just Alzheimer's patients. Modern medicine has produced new diagnostic tools, from scanners to genetic tests, that can find diseases or predict disease risk decades before people would notice any symptoms.

At the same time, many of those diseases have no effective treatments. Does it help to know you are likely to get a disease if there is nothing you can do?

"This is the price we pay" for the new knowledge, said Dr. Jonathan D. Moreno, a professor of medical ethics and the history and sociology of science at the University of Pennsylvania.

"I think we are going to go through a really tough time," he added. "We have so much information now, and we have to try to learn as a culture what information we do not want to have."

Some doctors, like Dr. John C. Morris of Washington University in St. Louis, say they will not offer the new diagnostic tests for Alzheimer's — like M.R.I.'s and spinal taps — to patients because it is not yet clear how to interpret them. He uses them in research studies but does not tell subjects the results.

"We don't know for certain what these results mean," Dr. Morris said. "If you have amyloid in your brain, we don't know for certain that you will become demented, and we don't have anything we can do about it."

But many people want to know anyway and say they can handle the uncertainty.

That issue is facing investigators in a large federal study of early signs of Alzheimer's. The researchers, who include Dr. Morris, have been testing and following hundreds of people aged 55 to 90, some with normal memories, some with memory problems and some with dementia. So far, only investigators know the results. Now, the question is, should those who want to learn what their tests show be told?

"We are just confronting this," said Dr. Richard J. Hodes, director of the National Institute on Aging. "Bioethicists are talking with scientists and the public about what is the right thing to do."

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United States Top 500 Medical Apps | App Annie

Medicine 2.0 « ScienceRoll

Medicine 2.0

I'm pretty sure web 2.0, the new generation of web services, will (and already is playing) play an important role in the future of medicine. These web tools, expert-based community sites, medical blogs and wikis can ease the work of physicians, scientists, medical students or medical librarians and can help patients how to find reliable medical information online.

I believe the new generation of web services will change the way medicine is practiced and healthcare is delivered.

So I decided to collect sites, presentations and services that could be helpful for medical experts and patients.

Science 2.0 - Medicine

• Create a place where world-class scientists write articles and discuss issues without being filtered by size or editorial limitations, where there are no political or cultural agendas, and the audience can read great science directly from the sources and maybe learn some new things.

• We created a place where everyone who wants to write about science can write to a large potential audience, regardless of popularity. There are other places where scientists can write but writers are lost in a sea of 170 million random blogs. Everyone in the audience is here to read about science and we have 1,800,000 articles read per month so your audience is already here. You can just write good articles and have fun and engage people.

Doctor’s networks - an emerging engagement channel | InPharm

The last four years have seen an extraordinary growth in physicians' social networks and a rapid increase in levels of activity and interest.

I've been tracking them since day one, and have worked with many of the networks on a variety of projects.

These networks reflect the great influence the internet age is having on medical practice.

Research suggests that regardless of cultural differences, doctors around the world now view the internet as essential to how they practice. And around a fifth can be identified as highly 'e-reliant'. One of the measures of this is where they get their clinical information, and more than 75% are saying they are getting that information online.

One of the key developments for the industry came in October 2007, when Pfizer announced a strategic partnership with US social network Sermo. Pfizer said the alliance was part of its commitment to engage in "peer-to-peer medical dialogue with physicians" to meet the mutual goal of helping patients. Jeffrey Kindler, the chief executive of Pfizer indicated that it wanted to put the 'hard sell' tactics behind it, as this is not what doctors wanted - instead it would try and build 'a more open and honest' discussion.

I was part of a group of pharma people who were invited by Sermo to a Japanese restaurant in Princeton in the week following the Pfizer deal. They walked us through everything they were doing, and their vision of the future, and this certainly caused quite a stir in the industry.

There are some who question the motives behind Pfizer's move. Following the news, John Mack's Pharma Marketing Blog carried a satirical cartoon depicting Pfizer as a predatory cat and Sermo and its online doctors as a bowl of goldfish. Its paws wrapped around the bowl, the cat says: "I for one am glad we can have an open dialogue."

Whatever your view, the Pfizer/Sermo partnership represents a major shift in how medical information is exchanged, and this quite rightly caused a stir when it was first announced.

So that was October 2007, but where are we today? In those three years, the US has seen a proliferation of physicians' networks. In terms of their number, diversity, success in raising venture capital funding and pharma participation, the US ones are still probably setting the pace, but less so than a few years ago.

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Friday, December 17, 2010

Faulty DePuy Artificial Hip Points to Broken Implant System -

A recently recalled artificial hip made by a unit of Johnson & Johnson, designed to last 15 years or more, is failing worldwide at unusually high rates after just a few years.

One of the most troubled orthopedic implants of the past decade, this artificial hip — known as the A.S.R., or Articular Surface Replacement — was originally promoted as a breakthrough in design that would last longer and provide patients more natural movement.

But many patients soon developed inexplicable pain, and surgeons, when replacing the implant, discovered mysterious masses of dead tissue near the thighs of some patients.

Until late summer, officials at the Johnson & Johnson unit, DePuy Orthopaedics, the largest maker of replacement hips worldwide, maintained that the A.S.R. was performing on a par with competing devices. But interviews with doctors indicate that DePuy received repeated warnings that the implant was failing and that surgeons were abandoning it.

The brief and troubled life of DePuy's A.S.R. hip points to a medical implant system that is piecemeal and broken on many fronts, critics say. Unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients.

That way, manufacturers can rapidly make small changes to a device to improve it. But those simpler procedures have also effectively created a loophole, experts say, that lets producers bundle a component from an unapproved implant into an existing design and sell a device with minimal testing. With the A.S.R., that process unfolded with devastating results.

"You are basically testing these devices in an uncontrolled way on a large number of people," said Dr. Sidney M. Wolfe, the director of the Public Citizen's Health Research Group and a longtime F.D.A. critic.

Officials at DePuy declined to be interviewed for this article or to respond to specific written questions. In the past, they have said that the company moved promptly to take appropriate action on the A.S.R.

Late last year, DePuy announced that it was phasing the device out, but asserted at that time that the decision reflected lagging sales, not safety issues. And some doctors report good results with the implant.

"We believe we made the appropriate decision to recall at the appropriate time given the available information," DePuy said in a recent statement.

The faulty DePuy device is one of a number of Johnson & Johnson products that have come under intense scrutiny in the last year, because of defects or manufacturing flaws that have prompted recalls of such household names as children's Tylenol to Rolaids.

DePuy officials cannot say how many patients in this country received an A.S.R. because the company, like other orthopedic makers, does not track such implants. The Johnson & Johnson unit sold two versions of the A.S.R. hip, one that the F.D.A. never cleared for sale in the United States and one that it did.

DePuy officials estimated that about one-third of some 93,000 patients worldwide who received some version of the implant were in the United States. Both versions of the A.S.R. shared a common component, a so-called cup, or the part of the joint that replaces a patient's hip socket. It was that cup's design, experts say, that would prove faulty.

As patients began complaining, doctors and regulators here remained largely unaware that the problem was widespread because no independent monitoring system exists in this country that tracks implant failures. Such a database, used in other countries, might have clued in American orthopedists to the problem. In addition, doctors who tried to sound an alert said they had been rebuffed by DePuy.

The director of Australia's orthopedic database said he believed that DePuy had been less than forthright about the A.S.R. Data in that country, he said, showed that in 2008 the A.S.R. was failing early at a rate higher than some competing devices.

"When it is clear to the orthopedic community that a company has not been honest, that is a problem," said Australia's registry's director, Dr. Stephen Graves. "I think that J.& J. has a major issue with DePuy."

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Marrow Donor Campaign Relied on Flirtation, Officials Say -

On its face, it seemed reasonable enough: a bone marrow registry sending recruiters to malls, ballparks and other busy sites to enlist potential donors.

But the recruiters were actually flirtatious models in heels, short skirts and lab coats, law enforcement officials say, asking passers-by for DNA swabs without mentioning the price of the seemingly simple procedure. And the registry, Caitlin Raymond International, was paying up to $60,000 a week for the models while billing insurance companies up to $4,300 per test.

In New Hampshire, where prosecutors say thousands of people appeared to have provided swabs, the attorney general is investigating the registry's marketing and billing practices. The registry is a nonprofit subsidiary of UMass Memorial Medical Center in Worcester, which said Thursday that it had stopped seeking donors in New Hampshire and using models altogether.

James T. Boffetti, the state's senior assistant attorney general, said the registry had hired models based on their photographs and had given them "explicit instructions" to wear heels and short skirts. The registry paid the models to approach potential donors at dozens of malls and events throughout New England, Mr. Boffetti said.

"The models worked the crowds, if you will," he said. "We were told basically they would engage a lot of younger men with some sort of flirtatious thing: 'Hey, don't you want to be a hero? Come on, do this!' "

If people expressed interest, Mr. Boffetti said, the models — who, for reasons that remain unclear, sometimes also wore electric-blue wigs — would hand them off to registry employees who would take mouth swabs.

"They got people to do this without telling them it could be a charge of $4,300 against their insurance," he said.

New Hampshire passed a law in 2006 requiring insurers to pay for tissue-typing tests for potential bone marrow donors. But at the time, Mr. Boffetti said, proponents told lawmakers that each test would cost $100 or less.

The state started investigating Caitlin Raymond International Registry last week after the city of Manchester, which is self-insured, complained that it had been billed more than $8,000 after two employees provided mouth swabs at the Mall of New Hampshire. The registry also recruited by setting up kiosks at Red Sox and Patriots games, bridal and auto shows, and colleges.

In its statement, UMass Memorial said it had recruited more than 185,000 potential donors in New England, using models "to help acquaint the public on how they can contribute to this lifesaving effort."

A hospital spokesman said there would be no further comment. Mr. Boffetti said the models had come from an agency in Boston, but he would not identify it, citing the continuing investigation.

Michael Boo, chief strategy officer for the National Marrow Donor Program, a nonprofit group in Minneapolis that oversees the world's largest registry of marrow donors, said it sometimes recruited at malls but had never considered enlisting the help of models.

"We hadn't heard of that until just this week," Mr. Boo said. "It's not a practice we follow."

FDA moves to revoke Avastin's approval for breast cancer - Washington Post

Federal regulators took the unusual step Thursday of moving to revoke approval of a drug that women with advanced breast cancer turn to in a last-ditch effort to save their lives.

The decision intensifies a politically charged debate over costly cancer drugs that appear to produce modest benefits - if any.

The Food and Drug Administration concluded that four studies indicate that the blockbuster drug Avastin, the world's best-selling cancer drug and among the most expensive, does not help patients with metastatic breast cancer live longer or provide other benefits that outweigh its potentially life-threatening risks.

"Today's decision was a difficult one for the agency," said FDA official Janet Woodcock, who stressed that the decision was made by officials with experience treating cancer patients, including some who had been "personally touched by the disease."

Woodcock added, "FDA is responsible for ensuring the products we approve for patients both effective and safe."

The FDA gave Genentech, which makes Avastin, 15 days to seek a hearing to review the decision, and the company immediately said it would make the request. That would mark the first time a company has challenged the FDA on such a decision. Genentech maintains Avastin does help some patients, noting that the European Medicines Agency had affirmed the drug's benefits the same day.

FDA Commissioner Margaret A. Hamburg must decide whether to grant company's request or proceed with the withdrawal. Until the final FDA decision, Avastin, which is prescribed to about 17,500 breast cancer patients a year, remains approved for breast cancer.

The FDA's step, which was recommended July 20 by an agency advisory committee, was based on new studies that officials concluded had not shown that the drug extends life and indicated that the drug slowed tumor growth for perhaps as little as a month. At the same time, Avastin can cause serious, potentially life-threatening side effects, including very high blood pressure, hemorrhages, heart attacks and heart failure.

Avastin was the first drug designed to fight cancer by blocking blood flow to tumors. But it is also one of the costliest of a new generation of anti-cancer medications that appear to eke out only a few extra months of life. It has global sales of $5.8 billion, and it is the top-selling product for Roche, whose Genentech unit makes it. Its use to treat breast cancer brings in about $855 million a year in revenue in the United States.

If the agency follows through with the revocation, the drug would remain available to treat cancer of the brain, colon, kidney and lung, and doctors could continue to prescribe it for breast cancer as an "off-label" use.

But the loss of FDA approval for breast cancer would probably prompt insurers to stop paying for Avastin for metastatic breast cancer. Avastin costs about $8,000 a month. Medicare was awaiting the outcome of the FDA process before making a decision on whether to continue paying for Avastin, Woodcock said.

Breast cancer patients also would lose eligibility for a program in which Genentech caps the annual cost of the drug at about $57,000 for women making less than $100,000 a year.

The FDA is not supposed to consider cost in drug approvals, and Woodcock said price was not a factor. But the debate over Avastin has

Eric P. Winer, chief scientific adviser for the breast cancer advocacy group Susan G. Komen for the Cure, also expressed concern that cost might have influenced the agency.

"Though the FDA is not focusing on cost, I think it's hard, particularly in 2010, not to pay attention to the fact that this is a very expensive drug," said Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston.

The decision comes as Medicare is conducting an unusual review to determine whether to pay for the first vaccine approved to treat cancer for men with prostate cancer. The vaccine, called Provenge, costs about $93,000 per patient.

The possibility of Avastin losing authorization for breast cancer prompted anguish among some breast cancer advocates, doctors and patients, including some who started petition drives to persuade the FDA to retain the drug's authorization.

"This is horrific," said Pat Howard, 65, of Summerfield, Fla., who has been taking Avastin for five years and credits the drug with putting her cancer in remission. "This is like saying, 'We don't value your life.' I'm shocked. I'm totally shocked. Without Avastin, I'm going to die."

Internet chat rooms for women with breast cancer lit up with similar expressions of alarm.

Several experts and advocates argued that a some breast cancer patients clearly do benefit from Avastin, and they urged insurance companies to continue paying for the drug.

But other experts and consumer and patient advocates welcomed the announcement, saying the weight of the evidence was that Avastin was not beneficial and potentially harmful.

"We know how difficult it is to deal with breast cancer. We understand how painful it is that we do not know how to cure metastatic disease," said Fran Visco of the National Breast Cancer Coalition. "We need to focus advocacy, public policy and resources on saving lives and doing more good than harm."

The FDA approved Avastin for advanced breast cancer in 2008 despite divided opinion about its usefulness for that purpose. Only one study had found that the drug appeared to slow the growth of an advanced breast tumor, producing a delay of about five months. It remained unclear whether patients lived longer or experienced an improved quality of life.

The FDA authorized Avastin under a special program designed to make new treatments available as quickly as possible, with the understanding that pharmaceutical companies would conduct follow-up studies validating the effectiveness of the drugs.

Thursday, December 16, 2010

An E.R. Doc Learns the Economics of Street Drugs -

An E.R. doctor in the Pacific Northwest who writes a blog called "Movin' Meat" might seem an unlikely candidate to know the economics of street drugs. But since he treats overdoses, he's learned quite a bit. Recently, he noticed a spike in novice heroin injectors right around the time that the supply of OxyContin got very tight. His patients told him that since the price of OxyContin had tripled (if you could find it at all), they made the switch to heroin. A self-professed econ fan, the doctor spins a bit of analysis as well:

If I were a clever, real economist, I might neatly package the conclusion along the lines of the demand for opiates being relatively inelastic, but the brand (?) sensitivity is low, and once the incidental costs of heroin (inconvenience, lower quality, abscesses, disease, visibility) became lower than the absolute cost of oxycontin, the market suddenly tilted. (That's probably mostly gibberish, but it sounds economish.) As it is, I just shake my head at the sadness of it all and the seeming futility of interdiction as a strategy for dealing with drug abuse. Cut off one drug, and people switch to another, more harmful one. A funny sort of progress.

The Deadly Corruption of Clinical Trials - Mother Jones

It's not easy to work up a good feeling about the institution that destroyed your life, which may be why Mary Weiss initially seemed a little reluctant to meet me. "You can understand my hesitation to look other than with suspicion at anyone associated with the University of Minnesota," Mary wrote to me in an email. In 2003, Mary's 26-year-old son, Dan, was enrolled against her wishes in a psychiatric drug study at the University of Minnesota [1],where I teach medical ethics [2]. Less than six months later, Dan was dead. I'd learned about his death from a deeply unsettling newspaper series [3] by St. Paul Pioneer Press [4] reporters Jeremy Olson and Paul Tosto that suggested he was coerced into a pharmaceutical-industry study from which the university stood to profit, but which provided him with inadequate care. Over the next few months, I talked to several university colleagues and administrators, trying to learn what had happened. Many of them dismissed the story as slanted and incomplete. Yet the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Presshad reported. The danger lies not just in the particular circumstances that led to Dan's death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.

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Tuesday, December 14, 2010 ~ Med School Confidential

I hail from Vancouver, B.C., and, after obtaining dual degrees in Cell Biology & Genetics and in Psychology at theUniversity of British Columbia, countless volunteer stints, and a year doing research, I'm finally on my way to completing my Doctor of Medicine at UBC. Follow my journey through medical school as I discuss the ups and downs of being a trainee, the complexities and controversies of the medical field, and current events.

Sunday, December 12, 2010

Sarah Leavitt Dot Com » Tangles

"An extraordinarily moving and vivid account, in text and cartoon-style pictures, of the life and death of an Alzheimer's patient."—John Bayley, author of Elegy for Iris

What do you do when your outspoken, passionate and quick-witted mother starts fading into a forgetful, fearful woman? In this powerful graphic memoir, Sarah Leavitt reveals how Alzheimer's disease transformed her mother Midge—and her family—forever.

In spare black and white drawings and clear, candid prose, Sarah shares her family's journey through a harrowing range of emotions—shock, denial, hope, anger, frustration—all the while learning to cope, and managing to find moments of happiness. Midge, a Harvard-educated intellectual, struggles to comprehend the simplest words; Sarah's father Rob slowly adapts to his new role as full-time caretaker, but still finds time for word-play and poetry with his wife; Sarah and her sister Hannah argue, laugh, and grieve together as they join forces to help Midge get to sleep, rage about family friends who have disappeared, or collapse in tears at the end of a heartbreaking day.

Tangles confronts the complexity of Alzheimer's disease, and ultimately opens a knot of moments, memories and dreams to reveal a bond between a mother and a daughter that will never come apart.