Friday, May 15, 2009

Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs - Dr. Jerry Avorn

If you believe that the latest blockbuster medication is worth a premium price over your generic brand, or that doctors have access to all the information they need about a drug's safety and effectiveness each time they write a prescription, Dr. Jerry Avorn has some sobering news. Drawing on more than twenty-five years of patient care, teaching, and research at Harvard Medical School, he shares his firsthand experience of the wide gap in our knowledge of the effectiveness of one medication as compared to another. In Powerful Medicines, he reminds us that every pill we take represents a delicate compromise between the promise of healing, the risk of side effects, and an increasingly daunting price. The stakes on each front grow higher every year as new drugs with impressive power, worrisome side effects, and troubling costs are introduced.

This is a comprehensive behind-the-scenes look at issues that affect everyone: our shortage of data comparing the worth of similar drugs for the same condition; alarming lapses in the detection of lethal side effects; the underuse of life-saving medications; lavish marketing campaigns that influence what doctors prescribe; and the resulting upward spiral of costs that places vital drugs beyond the reach of many Americans.

In this engagingly written book, Dr. Avorn asks questions that will interest every consumer: How can a product judged safe by the Food and Drug Administration turn out to have unexpectedly lethal side effects? Why has the nation's drug bill been growing at nearly 20 percent per year? How can physicians and patients pick the best medication in its class? How do doctors actually make their prescribing decisions, and why do those decisions sometimes go wrong? Why do so many Americans suffer preventable illnesses and deaths that proper drug use could have averted? How can the nation gain control over its escalating drug budget without resorting to rationing or draconian governmental controls?
Using clinical case histories taken from his own work as a practitioner, researcher, and advocate, Dr. Avorn demonstrates the impressive power of the well-conceived prescription as well as the debacles that can result when medications are misused. He describes an innovative program that employs the pharmaceutical industry's own marketing techniques to reduce use of some of the most overprescribed and overpriced products.
Powerful Medicines offers timely and practical advice on how the nation can improve its drug-approval process, and how patients can work with doctors to make sure their prescriptions are safe, effective, and as affordable as possible.

What can reality TV teach us about clinical drug trials? - By Darshak Sanghavi - Slate Magazine

Few drug-trial studies have the time or money to study the actual health outcomes that people care about, such as whether the middle-aged man avoids a heart attack after a few decades, the hyperactive first-grader holds down a good job someday, or the menopausal woman remains free from a hip fracture when she's elderly. Waiting for these events would stifle any meaningful innovation, so doctors pick surrogate endpoints, which they hope serve as short-term checkpoints. Thus drugs trials for the preceding examples may just decide to measure the middle-aged man's cholesterol level, the youngster's symptom checklist for hyperactivity, and the woman's bone density with a DEXA scan.

Unfortunately, surrogate endpoints can be problematic for two key reasons. First, their relation to the actual outcome of interest may be weak or nonexistent (just as impressing Donald Trump may fail to predict later business success); second, the intervention can improve the surrogate outcome but have bad side effects (just as the nonstop fancy dates that titillate viewers later lead to the couple's inevitable romantic disappointment).

Consider high serum cholesterol levels, which are a surrogate marker for later heart attacks. In the 1970s, a drug called clofibrate was discovered to markedly reduce cholesterol levels; unfortunately, a World Health Organization trial found it increased heart attacks. In 2002, the Women's Health Initiative trial showed hormone replacement caused blood clots and increased heart attacks by 29 percent, though it also made cholesterol numbers better. In 2006, Pfizer abruptly pulled the plug on its drug torcetrapib, which had cost roughly $1 billion to develop and had great effects on cholesterol levels—but also caused more heart attacks. Keep in mind that cholesterol levels, like blood pressure or levels of tumor markers in the blood, are at least considered "validated" markers.

In part, the increased focus on surrogate markers instead of hard outcomes came about in the 1990s, when the U.S. Food and Drug Administration was pressured to get HIV drugs to market rapidly for desperate patients, at the expense of using even "unvalidated" surrogate endpoints (like CD4 cell counts) that at the time were "reasonably likely" to predict benefit. For every turkey like clofibrate or torcetrapib, there are occasionally life-saving breakthroughs like protease inhibitors for HIV that may depend on a dizzying array of complicated surrogate endpoints.

How, then, can we encourage approval of drugs like protease inhibitors and cut the number of failures like clofibrate? The truth is that you can't, just like you can't easily figure out how to guarantee a happy marriage or find a surefire pop icon. You do the best with the information you have, then wait and see. In his terrific 2004 book Powerful Medicines, Jerry Avorn proposed a two-phased drug evaluation process in which "the initial FDA approval of a drug should be seen as the beginning of an intensive period of assessment, not the end." No doctor, he writes, would ever start a patient on a new medicine without scheduling any kind of follow-up, but that's exactly what the U.S. health care system now does.

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Thursday, May 14, 2009

Medicine and Horsemanship Program, Stanford

Medicine and Horsemanship trains medical students and other healthcare students and practitioners to develop awareness of the subtleties of self-presentation and communication that are necessary for the provider-patient relationship and all other professional encounters.

A major challenge for health science students in their clinical years and for healthcare providers throughout our careers is to conduct our relationships with patients, colleagues, "superiors," and employees in a manner that is professional, sensitive, perceptive, confident, and authentic. Especially with regard to patients, our interactions must be characterized by compassion, insight, and respect.

Horses are large, but nevertheless easily frightened, prey animals whose survival has depended on becoming exquisitely sensitive to body language, innuendo, and emotional tone, and to the position and movement of objects in their sensory fields. Horses react to signals and intents of which we aren't even aware;much less aware that we're communicating outward. Horsemanship requires an appreciation of the nonverbal as well as verbal messages that we give to others. Horses train us to notice at all times the information that we convey by touch, voice, and body language.

Horses develop in us the three nonintellectual, nonrational aspects of our intelligence—instinctual, emotional, and sensory—that may have atrophied in our quest for the correct answers on exams, the right diagnosis, or the most relevant journal article.

Unlike our patients, horses will tell us when we have violated their boundaries and have not clearly set our own. They show us when they're confused about our instructions. They let us know when we have touched them too roughly or inattentively. They show their appreciation for gentleness and honesty and clarity of intent. Because horses react to the most subtle human signals, they hold up a magnifying mirror to ourselves and our behaviors. In this mirror we see the image and path for our professional development and our personal growth.

Medicine and Horsemanship is taught in a ranch setting in one day or two consecutive-day programs for healthcare professionals and as a three-day series for students. Student sessions are held one month apart to allow for clinical contacts between sessions and case presentations at the second and third sessions. Medicine and Horsemanship is especially relevant given new requirements by the National Board of Medical Examiners and many specialty Boards for videotaped demonstration of clinical interviewing skills. This is a non-riding program and no previous horse is experience is required.

NBC News video:

Manual of Medicine and Horsemanship, Beverley Kane, MD:

Wednesday, May 13, 2009

Welcome to, the home of provocative physician opinion and
commentary on breaking medical news.

My name is Kevin Pho, and I am a primary care doctor board-certified
in Internal Medicine. My practice is located in Nashua, New Hampshire.

With health care at the forefront of the American mindset, patients
often have no idea what goes on behind the scenes of medicine today.

I aim to pull that curtain back.

The Wall Street Journal calls a "punchy, prolific blog
that chronicles America's often dysfunctional health care system
through the prism of a primary care provider," and other bloggers
have noted that "a lively comment stream on one of Kevin's posts
provides more insight on the day-to-day realities of health care than
any piece of journalism can ever hope to impart."

Drug company swag sways med students: Scientific American Blog

Can something as small as the logo on a pen sway a doctor to write a
prescription for one drug over another? You bet. Medical students, at
least, fall prey to the influence of drug company trinkets, says a
study published today in Archives of Internal Medicine.
Big-ticket items, such as a fancy dinner or NBA tickets, might seem
like more powerful persuaders than a free ceramic mug. But the
researchers conclude that, in fact, "subtle branding exposures are
important and influential."

After mounting criticism, many drugmakers halted the flood of pens,
notepads and clipboards that kept doctors scribbling within sight of
brand-name medicines under a voluntary code adopted by the
Pharmaceutical Research and Manufacturers of America (PhRMA) in
January. Companies can still take doctors out (as long as there's an
'educational' component to the event) and funnel gifts to those in

The study of tsotchkes, led by David Grande, an assistant professor
of medicine at the University of Pennsylvania, shows that even the
smallest item with a logo can influence the preference for one kind
of drug, especially in students who receive promotional materials at
school already.

To test the effectiveness of the small freebies, Grande and his team
had half of the 352 med school test subjects register sign in for the
testing session on a clipboard and notepad bearing the logo for
Lipitor, Pfizer's heavily promoted cholesterol-lowering drug. The
other half of the subjects used plain clipboards and notepads.

The student came from the University of Miami Miller School of
Medicine, which allows drug companies to distribute gifts, and the
University of Pennsylvania School of Medicine, where drug company
goodies are verboten.

After analyzing the students' attitudes toward Lipitor and the
competing generic simvastatin (sold by Merck as Zocor), the
researchers found that although most students preferred Lipitor,
fourth-year students from Miami (where gifts are allowed) had the
highest preference for the drug.

Pardoxically, the Lipitor exposure before the test made fourth-years
from Penn, unaccustomed to freebies, favor the brand less.
"Institutional policies can reverse the effects of drug marketing
tactics," Philip Greenland, chairman of preventive medicine and
professor at the Northwestern University's Feinberg School of
Medicine, writes in an accompanying editorial. "Data suggest that
adopting these more restrictive policies will reverse longstanding
adverse trends of physicians' prescribing habits," he concludes.

Tuesday, May 12, 2009

Chronic Pain Guidelines Suggest Opioids -

Few people think twice about taking aspirin or ibuprofen. But for those 75 and older, the high doses needed to treat chronic pain may be so dangerous that patients may be better off taking opioids instead, an expert panel has found.

New pain management guidelines issued by the American Geriatrics Society late last month removed those everyday medicines, called Nsaids, for nonsteroidal anti-inflammatory drugs, from the list of drugs recommended for frail elderly adults with persistent pain. The panel said the painkillers should be used "rarely" in that population, "with extreme caution" and only in "highly selected individuals."

Acetaminophen (like Tylenol) remains the top choice for treating chronic pain, but for those patients unable to get relief, the next step on the ladder is opioids, the guidelines say — as long as patients and their caregivers are screened for previous substance abuse.

The recommendation, which is already proving controversial, was made even though Nsaids are known to be fairly effective for chronic inflammatory pain conditions that often plague older adults, and even though opiates can be addictive.

"We've come out a little strong at this point in time about the risks of Nsaids in older people," said Dr. Bruce Ferrell, a professor of geriatrics at U.C.L.A. who is chairman of the panel. "We hate to throw the baby out with the bathwater — they do work for some people — but it is fairly high risk when these drugs are given in moderate to high doses, especially when given over time.

"It looks like patients would be safer on opioids than on high doses of Nsaids for long periods of time," he continued, adding that for most older people, the risk of addiction appears to be low. "You don't see people in this age group stealing a car to get their next dose."

But experts on pain say that it is difficult to make generalizations and that extreme caution must be used in prescribing opioids, no matter what the age of the patient.

"We're seeing huge increases nationwide of reports about the misuse and diversion of prescription drugs and related deaths," said Dr. Roger Chou, a pain expert who was not involved in writing the guidelines for the elderly but directed the clinical guidelines program for the American Pain Society. "The concerns about opioids are very real."

There is also a concern about side effects that may be associated with opioid use, including respiratory problems, constipation, fatigue and nausea, Dr. Chou said.

Many of the panelists reported having financial ties with drug manufacturers, but the chairman, Dr. Ferrell, said that he had no conflicts of interest regarding the medications under discussion and that the guidelines were peer-reviewed.

Dr. Ferrell acknowledged that scientific evidence on addiction among the elderly was limited because few studies focus on people 75 and older. The risks of Nsaids include ulcers and gastrointestinal bleeding and, with some drugs, an increased risk of heart attacks or strokes. The drugs do not interact well with medicines for heart failure and other conditions, and may increase high blood pressure and affect kidney function, experts said.

The guidelines are not meant to discourage the treatment of pain. Experts involved in developing the guidelines say chronic pain takes a huge toll on the elderly and too often goes untreated.

The new guidelines are also not meant to affect recommendations about taking baby aspirin to protect the heart; the amount of aspirin — 81 milligrams — is very small, a quarter of the dose contained in an adult pill.

A Journey Through Darkness - My Life With Chronic Depression -

IT IS A SPARKLING DAY IN MID-JUNE, the sun out in full force, the sky a limpid blue. I am lying on my back on the grass, listening to the intermittent chirping of nearby birds; my eyes are closed, the better to savor the warmth on my face. As I soak up the rays I think about summers past, the squawking of seagulls on the beach and walking along the water with my daughter, picking out enticing seashells, arguing over their various merits. My mind floats away into a space where chronology doesn't count: I am back on the beach of my adolescence, lost in a book, or talking to my old college chum Bethanie as we brave the bay water in front of her parents' house in Connecticut, where she comes to visit every summer.

In the 20 or so minutes of "fresh air" allotted after lunch (one of four such breaks on the daily schedule), I try to forget where I am, imaging myself elsewhere than in this fenced-off concrete garden bordered by the West Side Highway on one side and Riverside Drive on the other, planted with patches of green and a few lonely flowers, my movements watched over by a more or less friendly psychiatric aide. Soggy as my brain is from being wrenched off a slew of antidepressants and anti-anxiety medications in the last 10 days, I reach for a Coleridgian suspension of disbelief, ignoring the roar of traffic and summoning up the sound of breaking waves.

I have only to open my eyes for the surreal scene to come back into my immediate line of vision, like a picnic area without picnickers: two barbecue grills, bags of mulch that seem never to be opened, empty planters, clusters of tables and chairs, the entire area cordoned off behind a high mesh fence. Looking out onto the highway overpass there is a green-and-white sign indicating "Exit — West 178th Street"; nearer to the entrance another sign explains: "The Patients' Park & Garden is for the use of patients and their families only, and for staff escorting patients. It is NOT for staff use."

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Monday, May 11, 2009

More Canadian Health Blogs

Canadian Medicine

Canadian Medicine is the editors' news blog of Parkhurst Exchange, a monthly medical magazine based in Montreal, Canada. The blog editor is Sam Solomon.

Canadian Medicine covers health news from coast to coast to coast. We also host the largest available database of Canadian physician bloggers, with over 60 doctors' blogs (see the right-hand sidebar).

Industry Groups Pledge to Stem Health-Care Cost Increases

Volunteering to "do our part" to tackle runaway health costs, leading groups in the health-care industry have offered to squeeze $2 trillion in savings from projected increases over the next decade, White House officials said yesterday.

The pledge comes amid a debate over how, or whether, to overhaul the nation's health-care system, and Obama administration officials predicted that it will significantly increase momentum for passing such changes this year.

The groups aim to achieve the proposed savings by using new efficiencies to trim the rise in health-care costs by 1.5 percent a year, the officials said. That would carry huge implications for the national economy and the federal budget, both of which are significantly affected by health-care expenses.

Representatives from half a dozen health industry trade groups are scheduled to make a formal offer today in a White House meeting with President Obama.

"I don't think there can be a more significant step to help struggling families and the federal budget," a senior administration official said in a conference call with reporters. The official spoke on the condition of anonymity because the offer remains tentative.

The White House projects that the savings after five years under the proposal would mean about $2,500 a year in lower health-care bills for a family of four. Within 10 years, the savings would "virtually eliminate" the nation's budget deficit.

Despite such heady predictions, many aspects of the plan remain unclear. The groups did not spell out yesterday how they plan to reach such a target, and in a letter to Obama they offer only a broad pledge, not an outright commitment.

In addition, White House officials said, there is no mechanism to ensure that the groups live up to their offer, only the implicit threat of public embarrassment. And it would be difficult to track whether they come up with the promised savings, other than the imprecise measure of comparing current projections of health-care cost increases with future actual costs.

Nonetheless, White House officials were optimistic about the offer from industry officials, who previously tried to put up obstacles to health-care reform.

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