Beware the miracle cure - National Post

Until seven years ago, Robert Ducharme had "not a worry in the world," enjoying an active life and successful civil service career. Then, at age 48, a doctor diagnosed Parkinson's disease, and the degenerative illness advanced with frightening speed.

The Ottawa resident was soon all but helpless, the disorder's characteristic tremors leaving him unable to feed himself, dress or walk any distance. Two years ago, however, surgeons implanted a tiny electrode in the part of his brain that controls movement, connected it by leads to a battery pack installed near his collarbone, and switched on the electricity. Almost instantaneously, the debilitating tremors were gone.

"This has changed my life completely," said Mr. Ducharme yesterday. "This surgery, it's just an amazing, amazing thing."

About 75,000 Parkinson's patients and others worldwide have undergone the same deep-brain stimulation (DBS) procedure, the electrical current bringing about sometimes miraculous improvements.

But as it is applied experimentally to a wider and wider range of patients -- from severely depressed people to Alzheimer's sufferers and even the morbidly obese -- questions are being raised about the technology's growing allure.

Ethicists say patients, often carried away by glowing reports of the procedure's successes, need to be carefully briefed on DBS's unusual side effects, which have included mania, personality changes, marital discord and increased rates of suicide.

There is also concern about how that little electrode is sometimes changing patients' personalities, and worry about the less scrupulous applications that might come down the road. In an eery embodiment of the 2004 sci-fimovie Eternal Sunshine of the Spotless Mind, doctors will likely be able to erase people's painful memories through DBS within 10 to 20 years, said Dr. Mark Bernstein, a University of Toronto neurosurgeon and ethicist.

Already, he has been asked to peer-review a new study from Mexico using DBS to make patients less aggressive, where it is unclear how the patients were recruited and whether informed consent was gained. In China, it has been employed to counter heroin addiction.

"The slope is pretty slippery and it's a pretty long slope. There is almost nothing that is not possible [with DBS]," said Dr. Bernstein. "[But] if we go too far in our technological manipulation of people, of the brain, we are in danger of losing identity on an individual level and on a societal level."

After years of excitement about the technology's incredible potential, the ethics around it seem to be drawing increased attention. Canadian experts led discussion of the issues at a major U.S. bioethics conference this week. Dalhousie University is planning another symposium for next month. Those asking questions stress that deep-brain stimulation has done much good and that more benefits are sure to come to light, but say caution is needed given its unique capabilities.

Underlying the discussion is neurosurgery's most shameful hour: The widespread use of lobotomies in the 1940s and 1950s, with little supporting evidence and often devastating results.

Scientists note that DBS is different in many ways, not least because it is reversible. While lobotomies actually destroyed brain tissue, the stimulator can be turned off or even removed from the brain, usually without any damage.

But getting the patient's informed consent is a crucial pillar of any invasive treatment, and that becomes complicated with DBS, because the patients are often suffering from neurological or psychiatric conditions and the technology itself can affect their judgment.

One Dutch Parkinson's patient found that the stimulator embedded in his brain stopped his tremors, but seemed to trigger manic episodes: chaotic behaviour that led to serious financial debts, according to a 2004 journal paper. When the device was turned off, the mania disappeared but the Parkinson's tremors came back, and vice versa.

He was left with the troubling choice of keeping on the stimulator but having to be committed to a psychiatric hospital for the rest of his life, or turning it off and being confined, physically disabled, to a nursing home, noted Walter Glannon, a University of Calgary health sciences professor in a paper published this summer in the Journal of Clinical Ethics. The patient chose mania over the Parkinson's symptoms.

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http://www.nationalpost.com/news/canada/Beware+miracle+cure/3715860/story.html

Baseball's grand scam

Gregg Zaun, the former Toronto Blue Jay and current analyst for Rogers Sportsnet, introduced a segment on Wednesday about baseball and superstitions: Wade Boggs ate chicken before every game, teammates don't talk to a pitcher during a no-hitter, that kind of thing.

"Baseball players are the most superstitious people in the entire world!" Zaun declared. How he reached this conclusion is unclear, but speaking of bold declarations that lack actual evidence, the Sportsnet piece did not mention those bulky, colourful, "titanium-infused" necklaces worn by certain players for their alleged health benefits.

Turn on a playoff game, and you are bound to see someone sporting one of these necklaces, the most common of which is produced by a company called Phiten USA. Elvis Andrus and C.J. Wilson on the Texas Rangers, Joba Chamberlain and Curtis Granderson on the New York Yankees, Placido Polanco on the Philadelphia Phillies and Tim Lincecum on the San Francisco Giants: these are just the players I've noticed in the past couple of days; there are many others.

Colourful though they may be--the company has a licensing deal with Major League Baseball and co-ordinates products with the players' uniforms -- the $50 necklaces are not a fashion statement. Phiten says its products "work with your body's energy system, helping to regulate and balance the flow of energy throughout your body. Proper energy balance helps to alleviate discomfort, speed recovery and counteract fatigue."

My gracious, that sounds exciting, doesn't it? Put down the steroids, coach, I got me a new necklace!

Phiten says the claims are legitimate. It has developed something called the "high-intensity Phild Process," which creates "miniscule beads of titanium" that are embedded into its products.

This material now possesses the ability, it says, to "stabilize energy, permitting a greater flow of energy withless waste." There's even a nifty diagram with poor, sad, tired, disorganized ions on one side that are whipped into military-like efficiency via the Phild Process.

John Green, a professor of sports medicine at the University of Washington, told a Seattle newspaper: "I know of absolutely no scientific evidence to implicate titanium to improving performance." Other doctors have noted that while the body does produce electrical fields, there's zero evidence they can be influenced by titanium, and no evidence that they could be manipulated into decreasing fatigue levels.

Though Phiten alludes to its scientists on its website, there is nothing in the way of published research to back up its claims, and it hasn't sought regulatory approval to be treated as a medical product. Have a look at how baseball players actually wear these necklaces: loosely, usually with a t-shirt and jersey underneath. It seems a rather shoddy route of transmission.

At least Phiten goods seem a surefire testament to one thing: the placebo effect. Former NFL quarterback Damon Huard said a couple years back that "If I'm not wearing my necklaces to bed I'm a little stiffer. I think there is something to it." And that's just it: as long as you think a necklace is boosting your energy, you may feel a little more peppy.

Phiten says its products are more than a placebo, though you'll have to trust it on the science. No wonder, then, that a section of its site warns against buying fake Phitens. It would be a shame if someone just whipped up a bunch of plastic necklaces and then claimed that they could regulate the body's energy, wouldn't it?

http://www.financialpost.com/todays-paper/Baseball+grand+scam/3709491/story.html

Telus puts faith in high-tech health care - The Globe and Mail

Desmond Entwistle lay in a hospital bed, his temperature soaring, as life and death swirled around him.

He had been admitted to a Montreal hospital while undergoing painful treatment for acute leukemia when, one day in December of 2004, he was simply forgotten about for 18 hours.

When staff took his temperature and realized he had likely picked up an infection, they plunged a needle into him, according to his son. They failed to notice the MedicAlert bracelet clasped around his father's wrist, which said that he was allergic to penicillin. He went into severe toxic shock and died six days later.

"They pumped him full of penicillin and killed him," his son, Darren Entwistle, the chief executive officer of Telus Corp., T-T said in an interview.

Four years earlier, driven by a hard business case, Mr. Entwistle began steering the Vancouver-based telecommunications giant into a major bet that it can help fix the sort of problem that would later contribute to his father's death.

Canada's health records system, based largely on paper and bracelets, is "arcane," he says, and in bringing it into the 21st century there is the opportunity for both profit and social good.

One can see the early result of the Telus plan at work in the emergency room of The Ottawa Hospital.

On a late afternoon recently, veteran physician Adam Cwinn could be found brushing his fingers across the glass surface of an iPad to zoom in on a chest X-ray.

The hospital plans to order 3,000 iPads by the middle of next year. Behind this move is Telus, which is providing the wireless network and has aggregated the hospital's databases on Telus software.

As its rivals buy up media properties in multi-billion-dollar blockbuster acquisitions, Telus is quietly hoping that medical institutions across the country are ready to follow The Ottawa Hospital's lead and dive into a new era of advanced health care technology. That would mean a surge in profit from a division that has annual revenues of about $400-million.

The move, industry watchers say, has relatively little risk for such a potentially huge payoff: It puts Telus in the lead position ahead of the intense strain that baby boomers will inflict upon this country's already-struggling and outdated health care system, at precisely the time when advanced technology such as tablets can finally offer a viable solution. There are just two small problems: Doctors often resist change and the whole thing is dependent on the political will to implement electronic solutions at a time of tight budgets and electronic health scandals.

"This is going to be the challenge that defines our lifetime," Mr. Entwistle says. "We have a ton of antiquated technology out there."

Before he got his iPad, Dr. Cwinn said, he spent way too much time checking printed charts, darting from patients' bedsides to desk-bound PCs and walking around the hospital to see what his staff were up to and which beds were empty.

Staring down at the chest X-ray, he says, "You wouldn't make a diagnosis with this, but for interacting with patients, it's excellent." With a giant flat screen TV above a hub of computers, he can also keep better track of his department's physicians and instantly see the number of free beds available, even at the hospital's other campuses.

He can also access crucial information right at a patient's bedside. Turning to the iPad, he pushes on an "allergies" tab. A list pops up.

Mr. Entwistle, in a later interview, says, "I wish they had that sort of technology when my father was ill."

And this is just the sexy, high-tech veneer; the much more crucial changes are happening elsewhere, with the hospital's vast databases merging into one flow of information for the first time.

For many businesses, this type of technology isn't revolutionary. But hospitals are renowned for being reluctant to change. For that reason, Dale Potter, The Ottawa Hospital's chief information officer, was hired from the private sector two years ago to shift the large institution onto a new path.

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http://www.theglobeandmail.com/globe-investor/telus-puts-faith-in-high-tech-health-care/article1766042/singlepage/#articlecontent

Is affirmative action for men the answer to enrolment woes? - The Globe and Mail

For Harold Reiter the tipping point was the entering class of 2002.

As the new chair of admissions at McMaster University's medical school, he took one look at the proportion of women admitted - a whopping 76.9 per cent - and wondered what had happened to the men.

The gender gap at the university's Michael G. DeGroote School of Medicine was one of the widest in the country and one of the factors that prompted Dr. Reiter to rethink the admissions criteria.

"It was those very numbers that made me start to look at the breakdown of the applicant pool, in terms of the ratio of male to female, and the discovery of what was, I think, an over-emphasis on grade point average," he said.

Basing admissions mostly on marks, it seemed, had contributed to the decline of men's numbers in medical schools. Dr. Reiter, who was new to the position, decided the school should put less emphasis on marks and broaden its requirements, which eventually it did. The proportion of men has since slightly increased.

Dr. Reiter's candour is rare. Admissions officials are uncomfortable acknowledging that they are even troubled by the lack of men in medical school. During the past decade, men's interest in medicine has hardly budged, while women have been drawn to doctoring in ever higher numbers - a trend many regard as yet another sign of males slipping in the sphere of academics. The imbalance is greatest in Quebec, where women make up more than 70 per cent of students at francophone medical schools.

Medicine has been flagged as a field where the gender imbalance could lead to a shortfall of labour - just as an aging population increases demand. Research shows that female doctors are more inclined to work part-time than their male colleagues, and avoid certain specialties, such as surgery, as they balance demands of raising a family.

Nick Busing, president of the Association of Medical Faculties of Canada, says "this is a major debate, about getting the right balance of men and women in medicine."

Asked to explain the sudden 20-percentage-point jump in male students admitted to the University of Calgary's medical school between 2004 and 2005, for instance, Dr. Ian Walker, director of undergraduate admissions, was dismissive.

Dr. Walker said the fluctuations were random. "We had no concerted gender factor in our admissions process whatsoever," he said. "That is just a statistical blip."

However, according to Paul Cappon, McMaster is not the only university that has done something about the gender gap.

Dr. Cappon, president and CEO of the Canadian Council on Learning, says that for the past five to eight years, some universities across the country have been tinkering with admissions to boost the number of men in medical school - looking beyond marks to give male applicants, in particular, credit for things like community service.

He predicted no one would say it was going on.

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http://www.theglobeandmail.com/news/national/time-to-lead/failing-boys/is-affirmative-action-for-men-the-answer-to-enrolment-woes/article1766432/

Health Insurers Test New Payment Incentives for Cancer Care - NYTimes.com

Several large health insurers, including UnitedHealthcare and Aetna, are focusing on one of the country's most costly diseases: cancer.

The insurers have begun tightening oversight of the care provided to patients with many different types of cancer, hoping to lower expenses by experimenting with new ways to pay specialists.

UnitedHealthcare plans to announce on Wednesday a one-year project with five oncology practices, offering doctors an additional fee. The new fee is meant to encourage doctors to follow standard treatments rather than opting too often for individualized and unproven courses of therapy, which can include the most expensive drug combinations. By proposing a different type of payment structure, companies hope to lower doctors' dependence on a system that generates substantial sums for cancer specialists who routinely favor top-of-the line treatments.

Regional insurers in some states, including California, Washington and Pennsylvania, are negotiating similar limits with doctors and their clinics. WellPoint, another large insurer, is developing a way of paying oncologists to coordinate and manage patient care.

By almost any measure, cancer treatments can be exorbitantly expensive. Cancer care in the United States costs almost $100 billion a year, and medical bills for the average patient on chemotherapy can top $100,000 a year.

With the new health care law, everyone is under pressure to find ways to save money. Many specialists favor the most aggressive care even if there is little to no evidence the patient will benefit, because both doctors and patients have every incentive to spare no expense. Patients and their families often demand one last treatment. And oncologists can reap tremendous profits, sometimes earning more than half of their income on the difference between what they pay for chemotherapy drugs and what they charge the insurers for the patient's treatment plan.

Dr. Lee Newcomer, the oncologist who is heading the UnitedHealthcare program, said that yearly double-digit increases in the cost of cancer care had forced insurers to confront the issue. "Oncology, or cancer care, has been a bit of a sacred cow," he said.

With life and death questions at stake, insurers and supporters are quick to promote the new measures as a way to extract cost savings and also as a way to ensure that terminally ill patients are not subjected to unnecessary, often exhausting treatments that provide no hope.

Still, detractors worry that these changes could represent a first step toward denying patients additional treatments or the latest chemotherapy regimen based solely on the cost. In other words, they argue that even if oncologists still decide what course of treatment a patient should receive, as these new plans allow, the new effort could be viewed as a move toward rationing care at the end of life.

"We do not want to get into the realm where they are restricting treatments when they are clearly indicated," said Dr. David Eagle, an oncologist who is the president of the Community Oncology Alliance, a nonprofit lobbying group for community oncologists, who generally practice outside of an academic medical center.

"In my view, the insurance companies have the ultimate conflict of interest," Dr. Eagle said. But many cancer specialists acknowledge that the current payment system is unsustainable. "It has all the potential to bankrupt the system," said Dr. Michael Neuss, an oncologist in private practice in Cincinnati. He described the existing payment plans as "our dirty little secret."

"A lot of us want to get out of selling drugs," he said.

Companies are also springing up to develop treatment guidelines and serve as intermediaries between oncologists and health plans. US Oncology, a network of affiliated cancer doctors, teamed up with Aetna in May to develop a program to persuade doctors to follow treatment guidelines.

Another company, P4 Healthcare, is working with Highmark, a Pennsylvania insurer, and others. Cardinal Health, the large health care services company, bought P4 in July.

"There's a lot of money to be made and saved," said Dr. Peter Bach, a health policy analyst and physician at Memorial Sloan-Kettering Cancer Center in New York, who also served as a consultant to the federal Medicare program.

For example, doctors could choose less expensive therapies. When an oncologist considers different treatments, "it's hard not to look at price differentials," Dr. Bach said. In treating one type of lung cancer, for example, doctors can select from as many as eight treatments that are generally considered appropriate. Their costs under the Medicare program range from about $1,300 to $7,000 a month.

Dr. Marcus Neubauer, a doctor near Kansas City, Kan., whose practice is affiliated with US Oncology and one of the five involved in the UnitedHealthcare experiment, pointed to the effect of rising costs when people are required to pay a large amount of their overall medical bills. "It's not just a payer problem; it's a patient problem, too," he said.

Some insurers say there may be savings if doctors just follow standard treatments, rather than a variety of alternative regimens, for patients with the same type of cancer. "In medical oncology, there is tremendous variability in the way care is delivered," said Dr. Lonny Reisman, Aetna's chief medical officer.

Aetna and US Oncology recently compared what happens when doctors treating certain lung cancer patients followed guidelines with what happens when the doctors did not. According to the analysis, treatment costs over a 12-month period were 35 percent lower when doctors adhered to standards, with no effect on patients.

Aetna is now working with about 250 doctors in Texas and says it plans to expand the program next year to include even more cancer specialists in its network. In California, Blue Shield joined with Hill Physicians Medical Group to treat a group of state workers in Sacramento. Local oncologists are being rewarded for saving money, but Hill has made sure the doctors are still getting paid even if the patients' care becomes very expensive.

Joseph P. Newhouse, a health policy professor at Harvard who has studied how the Medicare payment system affects doctors' choice of treatments, suggested that some payment options might give doctors an incentive to stop treatments if they lose money or make too much by not actively treating patients. "Wherever you set" the incentives, he said, "you're going to make errors."

In the UnitedHealthcare program, for example, oncologists still get a fee even if the patient is not getting chemotherapy. To make sure no one is stinting on care, the oncologists involved review one another's treatment decisions and results. The doctors involved in the program say there is no danger that they will fail to treat patients who would benefit from another round of chemotherapy.

"These are patients we know by name," said Dr. Bruce Gould, an oncologist outside Atlanta who is one of the participants. "As medical oncologists, our goal is to take care of these patients and keep them living as long as possible."

Specialists do worry that the complexity of caring for cancer patients may make any hard-and-fast rules about treatments difficult. Dr. Neuss offered an example involving two drugs, with the cheaper one requiring patients to undergo a much longer treatment than the more expensive choice. "What's the patient's time worth in that equation?" he asked.

Dr. Newcomer of UnitedHealthcare acknowledged that some trade-offs were not clear cut but could be judged on factors like the difference in cost between the drugs — is it a few hundred dollars or a few thousand? "I think that's a perfectly legitimate debate," he said.

http://www.nytimes.com/2010/10/20/health/policy/20cancer.html?src=me&ref=health

Dollars for Docs - ProPublica

Drug companies have long kept secret details of the payments they make to doctors for promoting their drugs. But seven companies have begun posting names and compensation on the Web, some as the result of legal settlements. ProPublica compiled these disclosures, totaling $258 million, into a single database that allows patients to search for their doctor. Receiving payments isn't necessarily wrong, but it does raise ethical issues.

http://projects.propublica.org/docdollars/

Personal Health - Three R’s for Extreme Longevity - NYTimes.com

Esther Tuttle is nearing the end of the 10th decade of a remarkably productive and adventurous life. If all continues to go as well as it has to date, next July 1 she will join the rapidly growing clan of centenarians, whose numbers in the United States have increased to 96,548 in 2009 from 38,300 in 1990, according to the Census Bureau.

At age 92, Mrs. Tuttle (best known as Faity, her childhood nickname) wrote a memoir with the prescient title "No Rocking Chair for Me" (iUniverse) displaying an acute memory of events, names, dates and places that she retains as she approaches 100.

At 30 years her junior, I couldn't begin to recall the kinds of details that remain fresh in her still very active mind. I can only hope, should I live that long, to be as vibrant and physically fit as she is.

What, I asked, is the secret to her longevity? Is it genetics? Perhaps, but it's hard to say. Her parents died at ages 42 and 50, leaving her an orphan at age 11, along with three siblings, one of whom did live to 96.

Genes do play a role in longevity. Dr. Nir Barzilai, a geneticist at the Albert Einstein College of Medicine in New York, reports that centenarians are 20 times as likely as the average person to have a long-lived relative. But a Swedish study of identical twins separated at birth and reared apart concluded that only about 20 to 30 percent of longevity is genetically determined. Lifestyle seems to be the more dominant factor.

As Mrs. Tuttle said in clarion tones that belie her advanced age: "I am blessed and I've worked on it. You've got to work, be cheerful and look for something fun to do. It's a whole attitude.

"If you respect what the doctors tell you to do, you can live a long life, but you have to do it. You can't ignore the advice."

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http://www.nytimes.com/2010/10/19/health/19brody.html?src=me&ref=general

The Shriver Report || A Woman's Nation Takes on Alzheimers

Welcome to A Woman's Nation. Women are half the work force, raise our children and care for our elderly. Now there's a new pressure on this Woman's Nation: Alzheimer's disease. Maria Shriver and the Alzheimer's Association—the leader in Alzheimer care, support and research—released The Shriver Report: A Woman's Nation Takes on Alzheimer's on Oct. 14 to highlight the epidemic's effect on women as caregivers, advocates and people living with this disease.

The Shriver Report: A Woman's Nation Takes on Alzheimer's demonstrates that women are at the epicenter of the Alzheimer's epidemic.  According to the Alzheimer's Association Women and Alzheimer's Poll unveiled in the report, women are almost two-thirds of all Americans with Alzheimer's and comprise 60 percent of the unpaid caregivers for family members and friends with Alzheimer's.  That means there are 10 million women who either have Alzheimer's or are caring for someone with the disease.  The toll Alzheimer's has on individuals and caregivers is further compounded by the financial burden felt by families and the U.S. government.

The economic impact of Alzheimer's disease—on government, families and business—totals about $300 billion per year in the United States. The cost of caring for a single person with Alzheimer's is a whopping $56,800 a year, the bulk of it borne by each family. And all of these numbers are about to explode. With the baby boomers entering their mid-60s, an Alzheimer tsunami is about to hit, with the number of people with the disease expected to triple to 16 million by 2050.

A Woman's Nation Takes on Alzheimer's is a comprehensive, multi-disciplinary anthology of every facet of Alzheimer's disease—medical, sociological, political and economic. The academic core of the report is composed of expert reviews of issues and trends, with analysis backed by the nationwide Alzheimer's Association Women and Alzheimer's Poll of 3,118 adults, including more than 500 Alzheimer caregivers.

But there's more to Alzheimer's than numbers. This report includes original photography by award-winning photojournalist Barbara Kinney and a kaleidoscope of personal essays. Contributors include Barbra Streisand, Terrell Owens, Soleil Moon Frye, ABC News "Nightline" anchor Terry Moran, CBS News correspondent Barry Petersen, former First Lady Laura Bush, President Ronald Reagan's daughter Patti Davis, Alzheimer's Study Group chairs Newt Gingrich and former Sen. Bob Kerrey, Secretary of Health and Human Services Kathleen Sebelius and Vice President Joe Biden. In addition, extraordinarily honest and moving essays by a diverse group of Americans—including teenage caregivers and women who are living with the disease today— further illustrate the toll Alzheimer's is taking on the American landscape.

As the country climbs out of a deep recession, A Woman's Nation Takes on Alzheimer's examines the current and projected cost of Alzheimer's to the nation and individual families. With 78 million baby boomers now moving into their later years, the cost of Alzheimer's to American society is expected to be $20 trillion between now and the year 2050.

Unpaid family caregivers are on the frontlines of the battle against Alzheimer's. Over 11.2 million Americans provide billions of hours of unpaid care to people with Alzheimer's and other dementia. More often than not, women report stepping up to become the caregiver because no one else in their family will do it, and 40 percent of them say they had no choice. One-third of female Alzheimer and dementia caregivers are part of the Sandwich Generation, with children or grandchildren under the age of 18 living in their homes; as a result, women face a double burden. Caregivers' own heath care costs an additional $4 billion a year due to the emotional and physical stress and strain of caregiving.

Caregiving at home almost always affects work and other responsibilities, and A Woman's Nation Takes on Alzheimer's finds that working women feel they get less support for elder care than they do for child care. Almost half of women caregivers report they have tried to get time off from work for their caregiving duties, but couldn't get it.

This is the second in a series of Shriver Reports examining transformational moments in American culture and society. Last year, Maria Shriver and the Center for American Progress published The Shriver Report: A Woman's Nation Changes Everything, a landmark study examining how American families live and work today, now that women are half of all the country's primary and co-breadwinners. The report launched a national conversation about the far-reaching consequences of women's shifting roles in society that continues today.

http://shriverreport.com/

When Avandia and Other Drugs Cause Problems They Are Supposed to Prevent - NYTimes.com

In the past month, the Food and Drug Administration has concluded that in some cases two types of drugs that were supposed to be preventing serious medical problems were, in fact, causing them.

One is bisphosphonates, which is widely used to prevent the fractures, especially of the hip and spine, that are common in people with osteoporosis. Those drugs, like Fosamax, Actonel and Boniva, will now have to carry labels saying they can lead to rare fractures of the thigh bone, a surprising new discovery that came after another surprise — that they can cause a rare degeneration of the jawbone.

The other is Avandia, which is widely prescribed for diabetics, whose disease puts them at risk for heart attacks and heart failure. Two-thirds of diabetics die of heart problems, and a main reason for taking drugs like Avandia is to protect them from that.

But now the F.D.A. and drug regulators in Europe are restricting Avandia's use because it appears to increase heart risks.

In the case of bisphosphonates, the benefits for people with osteoporosis still outweigh the risk, bone experts say. And no one has restricted their use.

But the fact remains that with decades of using drugs to treat chronic diseases, the unexpected can occur.

Something new is happening, said Daniel Carpenter, a government professor at Harvard who is an expert on the drug agency. The population is aging, many have chronic diseases. And companies are going after giant markets, huge parts of the population, heavily advertising drugs that are to be taken for a lifetime.

And the way drugs are evaluated, with the emphasis on shorter-term studies before marketing, is not helping, Dr. Carpenter said.

"Here is a wide-scale institutional failure," he said. "We have placed far more resources and requirements upon premarket assessment of drugs than on postmarket."

Dr. Jason Karlawish, a University of Pennsylvania ethicist who studies the ways new treatments are developed and disseminated, expressed a similar concern.

"The point is not that the drugs are bad, but that drugs for these chronic diseases present a novel set of challenges about how to assess their safety," he said.

But such discussions make Dr. Ethel Siris, an osteoporosis expert at Columbia-Presbyterian Medical Center, nervous. Bisphosphonates have been extensively studied, she said, and the thigh fractures from bisphosphonates — while surprising — are very rare. Dr. Siris's fear is that people who really need the drugs will turn away from them.

It is not clear how the nation should respond to the new era of widespread drug use for chronic diseases.

"The basic underlying theme is that we don't have good long-term safety indices for common chronic diseases that we are treating with major drugs," said Dr. Clifford J. Rosen, director of the Maine Center for Osteoporosis Research. Dr. Rosen, in addition to studying osteoporosis, was on an advisory committee of the drug agency that examined the evidence that Avandia was linked to heart risks.

The difficulty is in figuring out how to assess the safety of drugs that will be taken for decades, when the clinical trials last at most a few years.

Today's system, which largely consists of asking doctors to report adverse reactions and of researchers' attempts to look at patient experiences in a variety of diverse databases, like records of large health plans, is ineffective, medical experts agree.

"There has to be a better system," Dr. Rosen said.

Congress recently gave the drug agency the power to require studies after drug approval, but the agency has used it sparingly.

Some, like Dr. Rosen and Dr. Carpenter, would like large clinical trials after a drug is approved and continuing for years, even for drugs that met all the premarket requirements.

Dr. Karlawish questions whether this is practical. Once a drug is approved, it can be difficult to persuade doctors to assign their patients randomly to one approved treatment or another, and the sort of studies being suggested would go on for many years, making them difficult.

He favors something different — the development of a national electronic drug database that would reveal drug use and complications. In the meantime, Dr. Karlawish said, he could not help marveling at the paradox of drugs causing what they were supposed to prevent.

"This is priceless," he said.

http://www.nytimes.com/2010/10/17/health/policy/17drug.html?hpw=&pagewanted=print

Op-Ed Contributor - The Magical Properties of Everyday Numbers - NYTimes.com

I recently wound up in the emergency room. Don't worry, it was probably nothing. But to treat my case of probably nothing, the doctor gave me a prescription for a week's worth of antibiotics, along with the usual stern warning about the importance of completing the full course.

I understood why I needed to complete the full course, of course. What I didn't understand was why a full course took precisely seven days. Why not six, eight or nine and a half? Did the number seven correspond to some biological fact about the human digestive tract or the life cycle of bacteria?

My doctor seemed smart. She probably went to one of the nation's finest medical schools, and regardless of where she trained, she certainly knew more about medicine than I did. And yet, as I walked out of the emergency room that night with my prescription in hand, I couldn't help but suspect that I'd just been treated with magic.

Certain numbers have magical properties. E, pi and the Fibonacci series come quickly to mind — if you are a mathematician, that is. For the rest of us, the magic numbers are the familiar ones that have something to do with the way we keep track of time (7, say, and 24) or something to do with the way we count (namely, on 10 fingers). The "time numbers" and the "10 numbers" hold remarkable sway over our lives. We think in these numbers (if you ask people to produce a random number between one and a hundred, their guesses will cluster around the handful that end in zero or five) and we talk in these numbers (we say we will be there in five or 10 minutes, not six or 11).

But these magic numbers don't just dominate our thoughts and dictate our words; they also drive our most important decisions.

Consider my prescription. Antibiotics are a godsend, but just how many pills should God be sending? A recent study of antibiotic treatment published in a leading medical journal began by noting that "the usual treatment recommendation of 7 to 10 days for uncomplicated pneumonia is not based on scientific evidence" and went on to show that an abbreviated course of three days was every bit as effective as the usual course of eight.

My doctor had recommended seven. Where in the world had seven come from?

Italy! Seven is a magic number because only it can make a week, and it was given this particular power in 321 A.D. by the Roman emperor Constantine, who officially reduced the week from eight days to seven. The problem isn't that Constantine's week was arbitrary — units of time are often arbitrary, which is why the Soviets adopted the five-day week before they adopted the six-day week, and the French adopted the 10-day week before they adopted the 60-day vacation.

The problem is that Constantine didn't know a thing about bacteria, and yet modern doctors continue to honor his edict. If patients are typically told that every 24 hours (24 being the magic number that corresponds to the rotation of the earth) they should take three pills (three being the magic number that divides any time period into a beginning, middle and end) and that they should do this for seven days, they will end up taking 21 pills.

If even one of those pills is unnecessary — that is, if people who take 20 pills get just as healthy just as fast as people who take 21 — then millions of people are taking at least 5 percent more medication than they actually need. This overdose contributes not only to the punishing costs of health care, but also to the evolution of the antibiotic-resistant strains of "superbugs" that may someday decimate our species. All of which seems like a rather high price to pay for fealty to ancient Rome.

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http://www.nytimes.com/2010/10/17/opinion/17gilbert.html?hp=&pagewanted=print