Do Clinical Trials Work? - NYTimes.com

EVERY spring, some 30,000 oncologists, medical researchers and marketers gather in an American city to showcase the latest advances in cancer treatment.

But at the annual meeting of the American Society of Clinical Oncology last month, much of the buzz surrounded a study that was anything but a breakthrough. To a packed and whisper-quiet room at the McCormick Place convention center in Chicago, Mark R. Gilbert, a professor of neuro-oncology at the University of Texas M. D. Anderson Cancer Center in Houston, presented the results of a clinical trial testing the drug Avastin in patients newly diagnosed with glioblastoma multiforme, an aggressive brain cancer. In two earlier, smaller studies of patients with recurrent brain cancers, tumors shrank and the disease seemed to stall for several months when patients were given the drug, an antibody that targets the blood supply of these fast-growing masses of cancer cells.

But to the surprise of many, Dr. Gilbert's study found no difference in survival between those who were given Avastin and those who were given a placebo.

Disappointing though its outcome was, the study represented a victory for science over guesswork, of hard data over hunches. As far as clinical trials went, Dr. Gilbert's study was the gold standard. The earlier studies had each been "single-arm," in the lingo of clinical trials, meaning there had been no comparison group. In Dr. Gilbert's study, more than 600 brain cancer patients were randomly assigned to two evenly balanced groups: an intervention arm (those who got Avastin along with a standard treatment) and a control arm (those who got the latter and a placebo). What's more, the study was "double-blind" — neither the patients nor the doctors knew who was in which group until after the results had been assessed.

The centerpiece of the country's drug-testing system — the randomized, controlled trial — had worked.

Except in one respect: doctors had no more clarity after the trial about how to treat brain cancer patients than they had before. Some patients did do better on the drug, and indeed, doctors and patients insist that some who take Avastin significantly beat the average. But the trial was unable to discover these "responders" along the way, much less examine what might have accounted for the difference. (Dr. Gilbert is working to figure that out now.)

Indeed, even after some 400 completed clinical trials in various cancers, it's not clear why Avastin works (or doesn't work) in any single patient. "Despite looking at hundreds of potential predictive biomarkers, we do not currently have a way to predict who is most likely to respond to Avastin and who is not," says a spokesperson for Genentech, a division of the Swiss pharmaceutical giant Roche, which makes the drug.

That we could be this uncertain about any medicine with $6 billion in annual global sales — and after 16 years of human trials involving tens of thousands of patients — is remarkable in itself. And yet this is the norm, not the exception. We are just as confused about a host of other long-tested therapies: neuroprotective drugs for stroke, erythropoiesis-stimulating agents for anemia, the antiviral drug Tamiflu — and, as recent headlines have shown, rosiglitazone (Avandia) for diabetes, a controversy that has now embroiled a related class of molecules. Which brings us to perhaps a more fundamental question, one that few people really want to ask: do clinical trials even work? Or are the diseases of individuals so particular that testing experimental medicines in broad groups is doomed to create more frustration than knowledge?

Researchers are coming to understand just how individualized human physiology and human pathology really are. On a genetic level, the tumors in one person with pancreatic cancer almost surely won't be identical to those of any other. Even in a more widespread condition like high cholesterol, the variability between individuals can be great, meaning that any two patients may have starkly different reactions to a drug.

That's one reason that, despite the rigorous monitoring of clinical trials, 16 novel medicines were withdrawn from the market from 2000 through 2010, a figure equal to 6 percent of the total approved during the period. The pharmacogenomics of each of us — the way our genes influence our response to drugs — is unique.

HUMAN drug trials are typically divided into three phases. In the first, researchers evaluate the safety of a new experimental compound in a small number of people, determining the best way to deliver it and the optimal dosage. In Phase 2, investigators give the drug to a larger number of patients, continuing to monitor its safety as they assess whether the agent works.

"Works" in this stage is broadly defined. Seeing that the drug has any positive effect at all — say, that it decreases the level of a blood marker associated with a disease — is often enough to move a drug to Phase 3. Even so, most experimental drugs fail before they get to Phase 3.

The few that make it to Phase 3 are then tested for safety and efficacy in hundreds or thousands of patients. This time, the outcomes for those taking the new drug are typically compared head-to-head with outcomes for those getting a placebo or the standard-of-care therapy. Generally, the Food and Drug Administration requires that two "adequate and well-controlled" trials confirm that a drug is safe and effective before it approves it for sale, though the bar can be lower in the case of medicines aimed at life-threatening conditions.

Rigorous statistical tests are done to make sure that the drug's demonstrated benefit is genuine, not the result of chance. But chance turns out to be a hard thing to rule out. When the measured effects are small — as they are in the vast majority of clinical trials — mere chance is often the difference between whether a drug is deemed to work or not, says John P. A. Ioannidis, a professor of medicine at Stanford.

In a famous 2005 paper published in The Journal of the American Medical Association, Dr. Ioannidis, an authority on statistical analysis, examined nearly four dozen high-profile trials that found a specific medical intervention to be effective. Of the 26 randomized, controlled studies that were followed up by larger trials (examining the same therapy in a bigger pool of patients), the initial finding was wholly contradicted in three cases (12 percent). And in another 6 cases (23 percent), the later trials found the benefit to be less than half of what was first reported.

It wasn't the therapy that changed in each case, but rather the sample size. And Dr. Ioannidis believes that if more rigorous, follow-up studies were actually done, the refutation rate would be far higher.

Donald A. Berry, a professor of biostatistics at M. D. Anderson, agrees. He, too, can rattle off dozens of examples of this evaporation effect and has made a sport, he says, of predicting it. The failures of the last 20 or so Phase 3 trials testing drugs for Alzheimer's disease, he says, could have been predicted based on the lackluster results from Phase 2. Still, the payoff for a successful Phase 3 trial can be so enormous that drug makers will often roll the dice — not on the prospect that the therapy will suddenly work, but on the chance that a trial will suggest that it does.

At a round-table discussion a few years ago, focused on the high failure rate for Alzheimer's drugs, Dr. Berry was amazed to hear one drug company researcher admit to such thinking out loud. The researcher said that when he and his team designed the Phase 3 trial, he thought the drug would probably fail. But if they could get an approval for a drug for Alzheimer's disease, it would be "a huge success."

"What he was saying," marvels Dr. Berry, "was, 'We're playing the lottery.' "

The fact that the pharmaceutical companies sponsor and run the bulk of investigative drug trials brings what Dr. Ioannidis calls a "constellation of biases" to the process. Too often, he says, trials are against "a straw-man comparator" like a placebo rather than a competing drug. So the studies don't really help us understand which treatments for a disease work best.

But a more fundamental challenge has to do with the nature of clinical trials themselves. "When you do any kind of trial, you're really trying to answer a question about truth in the universe," says Hal Barron, the chief medical officer and head of global development at Roche and Genentech. "And, of course, we can't know that. So we try to design an experiment on a subpopulation of the world that we think is generalizable to the overall universe" — that is, to the patients who will use the drug.

That's a very hard thing to pull off. The rules that govern study enrollment end up creating trial populations that invariably are much younger, have fewer health complications and have been exposed to far less medical treatment than those who are likely to use the drug.

Roughly 53 percent of new cancer diagnoses, for example, are in people 65 or older, but this age group accounts for just 33 percent of participants in cancer drug trials.

Even if clinical researchers could match the demographics of study populations to those of the likely users of these medicines, no group of trial volunteers could ever match the extraordinary biological diversity of the drugs' eventual consumers.

Drug makers are well aware of the challenge. "Listen, it's not lost on anybody that about 95 percent of drugs that enter clinical testing fail to ever get approved," says Dr. Barron. "It's not hard to imagine that at least some of those might have failed because they work very, very well in a small group. We can't continue to have failures due to a lack of appreciation of this heterogeneity in diseases."

So what's the solution? For subtypes of disease that are already known, it may be feasible to design small clinical trials and enroll only those who have the appropriate genetic or molecular signature. That's what Genentech did in developing the breast cancer drug Herceptin, which homes in on tumor cells that have an abundance of a protein called HER2.

And that's the strategy the company says it's pursuing now. Sixty percent of the new drugs in the works at Genentech/Roche are being developed with a companion diagnostic test to identify the patients who are most likely to benefit.

But given the dismal success rate for drug development, this piecemeal approach is bound to be slow and arduous. Rather than try to fit patients, a handful at a time, into the decades-old clinical-trials framework, we'd be far better off changing the trials themselves.

In fact, a breast cancer trial called I-SPY 2, already under way, may be a good model to follow. The aim of the trial, sponsored by the Biomarkers Consortium, a partnership that includes the Foundation for the National Institutes of Health, the F.D.A., and others, is to figure out whether neoadjuvant therapy for breast cancer — administering drugs before a tumor is surgically removed — reduces recurrence of the disease, and if so, which drugs work best.

As with the Herceptin model, patients are being matched with experimental medicines that are designed to target a particular molecular subtype of breast cancer. But unlike in other trials, I-SPY 2 investigators, including Dr. Berry, are testing up to a dozen drugs from multiple companies, phasing out those that don't appear to be working and subbing in others, without stopping the study.

Part of the novelty lies in a statistical technique called Bayesian analysis that lets doctors quickly glean information about which therapies are working best. There's no certainty in the assessment, but doctors get to learn during the process and then incorporate that knowledge into the ongoing trial.

Mark Gilbert, for his part, would even settle for something simpler in his next glioblastoma study. His definition of a successful clinical trial? "At the end of the day," he says, "regardless of the result, you've learned something."

Clifton Leaf is the author of "The Truth in Small Doses: Why We're Losing the War on Cancer — and How to Win It."

http://www.nytimes.com/2013/07/14/opinion/sunday/do-clinical-trials-work.html?

The Joy of Old Age (No Kidding) - Oliver Sacks - NYTimes.com

Last night I dreamed about mercury — huge, shining globules of quicksilver rising and falling. Mercury is element number 80, and my dream is a reminder that on Tuesday, I will be 80 myself.

Elements and birthdays have been intertwined for me since boyhood, when I learned about atomic numbers. At 11, I could say "I am sodium" (Element 11), and now at 79, I am gold. A few years ago, when I gave a friend a bottle of mercury for his 80th birthday — a special bottle that could neither leak nor break — he gave me a peculiar look, but later sent me a charming letter in which he joked, "I take a little every morning for my health."

Eighty! I can hardly believe it. I often feel that life is about to begin, only to realize it is almost over. My mother was the 16th of 18 children; I was the youngest of her four sons, and almost the youngest of the vast cousinhood on her side of the family. I was always the youngest boy in my class at high school. I have retained this feeling of being the youngest, even though now I am almost the oldest person I know.

I thought I would die at 41, when I had a bad fall and broke a leg while mountaineering alone. I splinted the leg as best I could and started to lever myself down the mountain, clumsily, with my arms. In the long hours that followed, I was assailed by memories, both good and bad. Most were in a mode of gratitude — gratitude for what I had been given by others, gratitude, too, that I had been able to give something back. "Awakenings" had been published the previous year.

At nearly 80, with a scattering of medical and surgical problems, none disabling, I feel glad to be alive — "I'm glad I'm not dead!" sometimes bursts out of me when the weather is perfect. (This is in contrast to a story I heard from a friend who, walking with Samuel Beckett in Paris on a perfect spring morning, said to him, "Doesn't a day like this make you glad to be alive?" to which Beckett answered, "I wouldn't go as far as that.") I am grateful that I have experienced many things — some wonderful, some horrible — and that I have been able to write a dozen books, to receive innumerable letters from friends, colleagues and readers, and to enjoy what Nathaniel Hawthorne called "an intercourse with the world."

I am sorry I have wasted (and still waste) so much time; I am sorry to be as agonizingly shy at 80 as I was at 20; I am sorry that I speak no languages but my mother tongue and that I have not traveled or experienced other cultures as widely as I should have done.

I feel I should be trying to complete my life, whatever "completing a life" means. Some of my patients in their 90s or 100s say nunc dimittis — "I have had a full life, and now I am ready to go." For some of them, this means going to heaven — it is always heaven rather than hell, though Samuel Johnson and James Boswell both quaked at the thought of going to hell and got furious with David Hume, who entertained no such beliefs. I have no belief in (or desire for) any post-mortem existence, other than in the memories of friends and the hope that some of my books may still "speak" to people after my death.

W. H. Auden often told me he thought he would live to 80 and then "bugger off" (he lived only to 67). Though it is 40 years since his death, I often dream of him, and of my parents and of former patients — all long gone but loved and important in my life.

At 80, the specter of dementia or stroke looms. A third of one's contemporaries are dead, and many more, with profound mental or physical damage, are trapped in a tragic and minimal existence. At 80 the marks of decay are all too visible. One's reactions are a little slower, names more frequently elude one, and one's energies must be husbanded, but even so, one may often feel full of energy and life and not at all "old." Perhaps, with luck, I will make it, more or less intact, for another few years and be granted the liberty to continue to love and work, the two most important things, Freud insisted, in life.

When my time comes, I hope I can die in harness, as Francis Crick did. When he was told that his colon cancer had returned, at first he said nothing; he simply looked into the distance for a minute and then resumed his previous train of thought. When pressed about his diagnosis a few weeks later, he said, "Whatever has a beginning must have an ending." When he died, at 88, he was still fully engaged in his most creative work.

My father, who lived to 94, often said that the 80s had been one of the most enjoyable decades of his life. He felt, as I begin to feel, not a shrinking but an enlargement of mental life and perspective. One has had a long experience of life, not only one's own life, but others', too. One has seen triumphs and tragedies, booms and busts, revolutions and wars, great achievements and deep ambiguities, too. One has seen grand theories rise, only to be toppled by stubborn facts. One is more conscious of transience and, perhaps, of beauty. At 80, one can take a long view and have a vivid, lived sense of history not possible at an earlier age. I can imagine, feel in my bones, what a century is like, which I could not do when I was 40 or 60. I do not think of old age as an ever grimmer time that one must somehow endure and make the best of, but as a time of leisure and freedom, freed from the factitious urgencies of earlier days, free to explore whatever I wish, and to bind the thoughts and feelings of a lifetime together.

I am looking forward to being 80.

Oliver Sacks is a professor of neurology at the N.Y.U. School of Medicine and the author, most recently, of "Hallucinations."

http://www.nytimes.com/2013/07/07/opinion/sunday/the-joy-of-old-age-no-kidding.html?src=me&ref=general 

Anxiety Lingers Long After Cancer - NYTimes.com

From the shock of the cancer diagnosis onward, depression can take its well-documented toll on patients. Even patients who appear to pack away their fears during the grinding treatment journey to becoming cancer-free concede that when the regimen ends, they unspool emotionally.

There has been less attention paid to the disease's emotional impact on spouses. They, too, can become depressed. But with the roles of caregiver and cheerleader thrust upon them, they may feel constrained about expressing their darker feelings.

Now a new analysis finds that within two years of a cancer diagnosis, the pervasiveness of depression in patients and their spouses tends to drop back to roughly the same levels as in the general population, only to be replaced by another mind-demon: anxiety, which can even intensify as time passes.

The analysis, which looked at 43 studies involving 51,381 patients with a range of cancers, found that over all, nearly 18 percent of patients experienced serious anxiety two to 10 years after their diagnosis, compared with about 14 percent of the general population. But in a cluster of studies that looked at couples, anxiety levels in that time frame grew to as high as 28 percent in patients and 40 percent in their spouses.

"Anxiety is a persistent problem long after the cancer has been diagnosed," said Dr. Alex J. Mitchell, the lead author of the study, which appeared in The Lancet Oncology, and a senior lecturer in psycho-oncology at the University of Leicester in England. Psycho-oncologists, often based at cancer centers, look at the psychological and social effects of cancer on patients during and after treatment.

Unlike depression, anxiety has not been looked at extensively in the long-term cancer population, and even less so in partners. "It appears to be at least equal and perhaps more of a problem for spouses than patients," Dr. Mitchell said. "But at least in the U.K., we're poor at helping family members when the patient is affected."

People who have not confronted a life-challenging illness may be perplexed by the residual anxiety in patients, long after they have successfully completed treatment.

"They think that when it's over, it should be over," said Jane Hyman, 66, a retired elementary school principal from Sharon, Mass., who was treated for breast cancer 16 years ago. "But the downside to being further out is that I've known many people who have had cancer more than once. "

Her body works like an unconscious calendar. In early June, she becomes edgy and nervous and begins staying awake till 2 a.m., reading. Then she and her husband check their real calendars and, sure enough, her annual checkup is just a few weeks away.

Dr. Laura B. Dunn, a professor of psychiatry and director of psycho-oncology at the University of California, San Francisco, said that although cancer is increasingly labeled a chronic illness, "it's different from arthritis in that it's more of a chronic threat. Some of us are wired to be attuned to threat." The anxiety is understandable, she said, because "no one can guarantee you a cancer-free survival."

"Some people can say, 'Yeah, it might recur, but I can't control that,' and they live their life anyway," she continued. But others, because of genes, past experience or temperament, have more difficulty doing that, she said, and "the anxiety may not decrease over time."

Dr. Mitchell said that in his clinical practice, key predictors of anxiety in family members included whether a caregiver felt out of control and unable to participate in the patient's care; witnessed an unexpected or unpredictable deterioration of a loved one; and "transitioned from being in an equal relationship to being a caregiver, a role you didn't ask for."

In at least two of the studies, more women than men turned out to have greater rates of anxiety. In a prostate cancer study, more spouses than patients experienced it, while in a study of gynecological cancers, the patients tended to be more anxious than their spouses.

But those results may reflect, in part, that so many men are raised not to be forthcoming about feelings like depression or anxiety. "My husband keeps his game face on," said Casey Malanga, of Milton, Mass., who is 33 and was treated for breast cancer in 2010. "He was never one to gush about his emotions. I think he does worry, but it calms his worry to say, 'I know what they've done is still working, and they are always monitoring you.' "

A couple's ability to manage anxiety may be more challenging when men are the patients, said Dr. Dunn, because the husband "doesn't want to worry his wife with every ache and pain, so he doesn't mention them. And he doesn't want to be micromanaged over every little symptom. But if the wife finds out, she'll worry even more because he didn't tell her."

The analysis did not identify certain cancers as having more psychological impact than others. Rather, the burden of the disease on an individual patient, including symptoms and treatment complications, was more telling than the type of cancer, Dr. Mitchell said.

Although the Lancet Oncology study did not look at the effects of cancer on children, other studies have noted the considerable emotional turmoil they can experience. Risk factors were variable, including the severity of the parent's disease, the depression exhibited by the parents themselves, and the age of the child — teenagers tended to have more psychosocial problems than younger children.

There were drawbacks to the current analysis. Most of the studies had little information about the precancer mental histories of the patients, for example, and they used variable methods to screen for depression and anxiety. But the findings underscore the need to address the long-term consequences of anxiety and other mood disorders among patients and those closest to them.

"Even in an era of scarce resources, hospital-based psycho-oncology programs should probably not be exclusively reserved for patients," said Dr. Ilana M. Braun, chief of the adult psychosocial oncology division at the Dana-Farber Cancer Institute in Boston Such programs, she says, should "be made available in some capacity to those in remission and to loved ones impacted by cancer in their family."

http://well.blogs.nytimes.com/2013/07/12/anxiety-lingers-long-after-cancer/?hp&pagewanted=print

When Lyme Disease Lasts and Lasts - NYTimes.com

Chronic Lyme disease is a highly controversial catch-all term for a host of long-lasting symptoms that may or may not stem from prior infection with the bacterium that causes acute Lyme disease. Often misdiagnosed and mistreated, chronic Lyme disease leaves thousands of people physically and mentally debilitated and without a medically established recourse.

Mary Rasenberger, 51, a New York lawyer, experienced "a series of ailments going back 10 years." She was finally given a diagnosis of chronic Lyme disease last summer after having been told that she had multiple sclerosis.

Her long-term symptoms were "aching joints, headaches and indescribable fatigue" that made her miserable and unable to exercise. In the last few years, two additional symptoms developed: neuropathy in her limbs and face, and vision problems. In an interview, she said she "woke up every day feeling sick"; if she became overheated, she felt as if she had the flu.

Yet a test for Lyme disease came back negative. Desperate, she finally consulted a Lyme "specialist," one of a number of doctors who treat patients with symptoms like Ms. Rasenberger's with long-term antibiotics, despite the fact that such a regimen has shown no significant or lasting benefit in controlled clinical trials. These trials involved randomly assigning patients to the antibiotic Rocephin (often administered intravenously) or a placebo, with neither patients nor those evaluating their symptoms aware of who got what.

Still, after several months on antibiotics Ms. Rasenberger, like many similar patients, said she felt "completely healthy for the first time in years." Each time she tries to stop the medication, her debilitating symptoms return.

Reports like Ms. Rasenberger's are hardly unusual, and experts now realize that some people who get Lyme disease go on to develop a chronic illness even if their initial infection was promptly diagnosed and correctly treated. Approximately 10 percent to 15 percent of people who are treated for medically documented Lyme disease develop persistent or recurrent symptoms of fatigue, musculoskeletal pain and cognitive complaints.

The condition is known as post-treatment Lyme disease syndrome, or PTLDS. "It is a real disorder, although nobody really knows what's happening," Dr. John N. Aucott, an infectious disease specialist in Lutherville, Md., said in an interview.

"A lot of patients have been told they're not really sick, just tired or depressed," he added. "But this is not normal fatigue, and it's not caused by depression" — although depression certainly can result from the patient's seriously diminished quality of life.

Antibiotic therapy for PTLDS is based on disputed reports that these patients may harbor hidden reservoirs of the spirochete causing Lyme disease, Borrelia burgdorferi, long after their initial treatment. But researchers who have studied the therapy have found it of little or no benefit, and many say the regimen is fraught with hazards that could be even worse than the illness.

Risks include the development of an antibiotic-resistant infection, intractable diarrhea, kidney or liver damage and, as happened to a 30-year-old woman treated with an antibiotic through a catheter, death from a systemic infection called sepsis.

People with PTLDS are not hypochondriacs seeking attention or sluggards wanting to avoid work or chores, Dr. Aucott said, though they may benefit from psychotherapy that helps them cope better with their symptoms.

"These are high-functioning people — couch potatoes don't get Lyme disease," he said. "They are not crazy, and the doctors who treat them are not evil. These are desperate people trying to get better, and well-intentioned doctors who are trying to help them."

But until the causes of PTLDS are discerned, it will be difficult for researchers to find effective therapies. Among the possible causes of the syndrome are prolonged post-infection fatigue and an autoimmune reaction to the infecting organism, according to a recent book by Dr. Adriana Marques of the National Institute of Allergy and Infectious Diseases.

As for why some people with PTLDS seem to benefit from intensive antibiotic therapy, at least temporarily, Dr. Aucott suggested a few theories. The antibiotics may have an anti-inflammatory effect that relieves pain and swelling. Alternatively, patients may have a low-level, persistent infection that is temporarily suppressed by antibiotics — but not killed by them. Or it may be that some PTLDS patients experience a placebo effect, improving because they believe the treatment will help and because someone is finally taking their symptoms seriously.

Complicating the picture is the fact that some people with PTLDS symptoms apparently never had Lyme disease in the first place, Dr. Marques said in an interview. There are other infectious organisms — Epstein-Barr virus, for example — that can produce similar symptoms and may be the real culprits.

But experts cannot rule out Lyme spirochete as a cause, either. Many, if not most, people who are infected with it never know they have been bitten by the tiny deer tick that spreads the bacterium from animals to people. They may never develop or notice the red rash that can result. Even when a rash occurs, only one in five is the characteristic bull's-eye associated with Lyme disease. Most are solid red and round or oval.

Such people may never receive treatment for the infection in its early stages and end up weeks, months, even years later with the kinds of symptoms that have plagued Ms. Rasenberger. Symptoms may develop gradually, as they did in my dog, which had minimal effects from a Lyme-carrying tick until nine months later, when he collapsed, unable to eat or drink on his own.

Both Dr. Aucott and Dr. Marques said more research is desperately needed if people are to get the help they need. "This is a huge disease that's only going to get bigger, yet it receives only a tiny fraction of the N.I.H. budget," Dr. Aucott said, referring to the National Institutes of Health.

Given the uncertainties about chronic Lyme disease, prevention is more important than ever. Avoid walking through brush and high grass. When hiking in the woods, camping, gardening or mowing the lawn, wear long, light-colored clothing and tuck pant legs into tightfitting socks. Spray exposed skin with a 20-percent DEET insect repellent and clothing with permethrin. Remove clothes before coming back indoors, and wash and dry them separately.

Shower as soon as possible after being outdoors, using a washcloth or loofah, and check your body carefully, especially in skin folds, for attached ticks. They should be carefully removed with a tweezer without crushing them by pulling gently and steadily near the mouth. Then apply an antiseptic to the site.

http://well.blogs.nytimes.com/2013/07/08/when-lyme-disease-lasts-and-lasts/?pagewanted=print

Who's Watching When You Look For Health Information Online? : Shots - Health News : NPR

When it comes to sensitive health information, government-run websites appear to do a better job protecting your privacy than many news and commercial sites.

A brief survey published online by JAMA Internal Medicine looked at how 20 health-related websites track visitors. They ranged from the sites of the National Institutes of Health to the health news section ofThe New York Times online.

Thirteen of the sites had at least one potentially worrisome tracker, according to the analysis performed by Dr. Marco Huesch, an assistant professor of health policy at the University of Southern California.

He also found evidence that health search terms he tried — herpes, cancer and depression — were shared by seven sites with outside companies.

The federally run sites and those affiliated with medical journals generally raised fewer flags than media sites. "It's wonderful to have consumers taking charge of their health," Huesch tells Shots. "But to see how common the third-party harvesting tools was left me disappointed."

Huesch says he's concerned that these tracking and sharing capabilities could erode consumers' trust in sources of online health information. Eventually, they might decide it's too risky to look for help on the Web. He cites confidentiality worries in the early days of AIDS that kept many people from getting tested and treated.

"Let's be very honest, I think this is a massive regulation failure," he says. The federal government, including the Federal Trade Commission, hasn't been aggressive enough in safeguarding privacy, he says. "We should be a little more mature in how we regulate these information markets."

He's pushing for better controls, not a blackout. "I'm not down on data," he says. "I want it treated with respect." Information could be used for good, he says, such as tailoring vaccination campaigns to reach people who are most likely to benefit.

For more information on how the technology and market for your online information work, see the archive of coverage on the topic by The Wall Street Journal. Huesch says the newspaper's stories inspired him to investigate the health sites.

If you're interested, you can do some research yourself. Try Ghostery, one tool Huesch used to find trackers. It's free. I aimed it at Shots and found nine items, most are related to social media, commenting or internal analysis. One called Rocket Fuel is a third-party tracker that Huesch flagged.

"Rocket Fuel is a tool for sponsorship messaging, which is stated in our privacy policies," NPR spokeswoman Anna Christopher Bross tells Shots. "We do not share search terms, and what we do share is what's clearly stated in the privacy policies."

http://www.npr.org/blogs/health/2013/07/08/200055678/whos-watching-when-you-look-for-health-information-online

How Faith Can Affect Therapy - NYTimes.com

Can belief in God predict how someone responds to mental health treatment? A recent study suggests it might.

Researchers at McLean Hospital in Belmont, Mass., enrolled 159 men and women in a cognitive behavioral therapy program that involved, on average, 10 daylong sessions of group therapy, individual counseling and, in some cases, medications. About 60 percent of the participants were being treated for depression, while others had bipolar disorder, anxiety or other diagnoses.

All were asked to rate their spirituality by answering a single question: "To what extent do you believe in God?"

The results, published in The Journal of Affective Disorders, revealed that about 80 percent of participants reported some belief in God. Strength of belief was unrelated to the severity of initial symptoms. Over all, those who rated their spiritual belief as most important to them appeared to be less depressed after treatment than those with little or no belief. They also appeared less likely to engage in self-harming behaviors.

"Patients who had higher levels of belief in God demonstrated more effects of treatment," said the study's lead author, David H. Rosmarin, a psychologist at McLean Hospital and director of the Center for Anxiety in New York. "They seemed to get more bang for their buck, so to speak."

One possible reason for this, he said, is that "patients who had more faith in God also had more faith in treatment. They were more likely to believe that the treatment would help them, and they were more likely to see it as credible and real."

Of the 56 people who expressed the strongest belief in God, 27 also had very high expectations for the treatment, while nine had very low expectations. In contrast, of the 30 patients who said they had no belief in God or a higher power, only two had high expectations for the treatment.

"It's one of the first studies I've read that actually looks at perhaps a mechanism" for "why we see some correlation between the strength of religious commitment or the strength of spiritual commitment and better outcomes," said Dr. Marilyn Baetz, a psychiatrist at the University of Saskatchewan who studies the effects of religion and spirituality on mental health. An earlier yearlong study by Dr. Baetz and her colleagues found that people with panic disorder who rated religion as "very important" to them responded better to cognitive behavioral therapy, showing less stress and anxiety, than those who rated religion as less important.

Assessing how religious practices affect health is difficult, in part because researchers can't randomly assign people to embrace religion or not, the way they might assign participants in a drug test to take a new medication or a placebo. Most studies of this relationship are observational, and people who are more or less religious may differ in other important ways, making it difficult to know whether religious faith is actually causing the effect or if it is a result of some other factor.

But teasing out the effects of faith on treatment outcomes may be an important goal. Most Americans believe in God — 92 percent, according to a 2011 Gallup poll, though the percentage among mental health professionals may be considerably lower. One study from 2003 found that 65 percent of psychiatrists said they believed in God, compared with 77 percent of other physicians.

Previous research has associated church attendance with increased life expectancy and, in some studies, a reduced risk of depression. But this study looked not at how often the participants went to church or at their religious affiliation but at their belief in a higher power.

"I think it's a scientifically sound way of measuring things that have to do with people's experience of spirituality," said Torrey Creed, an assistant professor of psychology in psychiatry at the University of Pennsylvania. "I think about this as a study of cognitive styles, that there's a pattern of thinking that helps people get better in treatment. And two examples of this pattern of thinking are 'I believe in treatment' and 'I believe in God.'"

Randi McCabe, director of the Anxiety Treatment and Research Center at St. Joseph's Healthcare in Ontario, said, "People's belief that something is going to work will make it work for a significant proportion of people," similar to the placebo effect.

"Your belief that you're going to get better, your attitude, does influence how you feel," Dr. McCabe continued. "And really, in cognitive behavior therapy, that is really what we're trying to change: people's beliefs, how they're seeing their world, their perspective."

Dr. Rosmarin offered further explanation for why religious faith might aid psychiatric treatment. "There's a vulnerability associated with physicality," he said. "I think people, psychiatric patients in particular, might recognize that vulnerability and recognize that things can't be counted on.

"Sometimes medications don't work, and sometimes psychotherapy doesn't work," he continued. "But if someone believes in something that is metaphysical, if someone believes in something spiritual, which would ostensibly be eternal, permanent, unwavering, omnipotent, then that could be an important resource to them, particularly in times of emotional distress."

http://well.blogs.nytimes.com/2013/07/10/how-faith-can-affect-therapy/?src=me&ref=general&pagewanted=print

Doctors Badmouthing Other Doctors - NYTimes.com

A physician friend known for her conscientious work recently disclosed that a year ago she was named in a malpractice lawsuit. The revelation rattled me not only because there were no discernible errors in the care she provided, but also because I couldn't believe who had provoked the patient to hire a lawyer.

It was another doctor.

"I'm shocked that nothing was done sooner," the other doctor had said when the patient went for a second opinion. "You could have died."

The patient later decided to sue.

Like many who heard the story, I was quick to criticize the other physician. Throughout training and regularly at work, we are reminded of the importance of professionalism and respect. Shifting blame, doctors are taught, demoralizes other clinicians, undermines patient trust and compromises patient outcomes.

Surely, I thought, the doctor who had trashed our colleague was out of line, his comments aberrant. But it didn't take long for me to recall instances when friends and I had been equally critical about other doctors' work. And while I wanted to remember those indiscretions as private, limited to a few colleagues at most, I wasn't entirely sure.

I had to wonder: are we all capable of talking like that in front of patients?

The answer, according to a recent study in The Annals of Internal Medicine, is an unqualified and disturbing, "Yes."

Over the last decade, few issues have garnered as much interest among health care experts as disrespectful behavior among doctors. While sociologists have devoted careers to researching the topic, it wasn't until the 1990s that the medical profession itself began to take serious note.

Spurred on by the increasing complexity of medicine, concerns about safety and patient satisfaction and an ever-growing urgency to contain costs, the Institute of Medicine convened a national panel of health care experts to discuss "the chasm" between what could be and what was actually being done for patients. In 2002, they published an ambitious report that called for a "sweeping redesign of the entire health system." Realizing that vision, said the panel, would require, among other changes, better collaboration and cooperation among physicians and the creation of a "culture of respect."

Medical schools, regulatory agencies, professional organizations and entire health care systems responded to this cri de coeur. Official definitions of professionalism were rewritten to incorporate the concepts of teamwork and shared responsibility. Schools added mandatory coursework on the whys and hows of working in a team. And licensing and accreditation boards began asking for evidence that doctors could not only lead, but that they also knew how to work as part of a team.

But this new study reveals that old habits and responses die hard.

Researchers trained three actors to portray "standardized patients" with advanced lung cancer who had recently moved to town after being treated by another doctor and who remained unsure about their diagnosis or prognosis. The actors, carrying medical records written to reflect only universally accepted guidelines of care, made a total of nearly three dozen office visits to various family physicians and cancer specialists working in the community.

The actors were not told to elicit the doctors' opinions about their previous care; but after analyzing transcripts from each office visit, the researchers found that in 40 percent of the consultations, doctors went ahead and spontaneously offered their opinion anyway. A tiny percentage of these comments were neutral; a third were supportive. The vast majority, however, were unabashedly critical, with the doctors' comments ranging from "Hell, you don't want to trust doctors," to "This guy's an idiot!"

"Doctors will throw each other under the bus," said Susan H. McDaniel, lead author of the study and a professor of psychiatry and family medicine at the University of Rochester Medical Center. "I don't think they even realize the extent to which they do that or how it can affect patients."

Probably, added Dr. McDaniel, most of the comments were unintentional. Faced with a constant pressure to cut costs, increase productivity and keep patients happy, plus the additional difficulty in this case of discussing prognosis with a terminal cancer patient, many of the doctors no doubt experienced significant levels of stress. In the moment, criticizing another physician to a patient might have felt like an effective way to fortify their own credentials and build up the patient's trust.

"There is probably something reassuring in saying, 'Boy, your doctor didn't do a good job and now I'm going to take care of you,'" Dr. McDaniel noted. "But those kinds of comments are bad for the patient."

To help remedy this problem, Dr. McDaniel began a physician coaching program at the University of Rochester Medical Center a year and a half ago. So far, she and her team have managed to work with approximately 150 doctors, observing them with patients and with colleagues, then offering feedback and support. Eventually they hope to expand the program. "When you really think about it, it's hard for people to regulate themselves when they get frustrated," Dr. McDaniel said. "And physicians get frustrated a lot."

She added: "There's a lot of attention focused on the patient experience, but I think we need to work on improving the clinician experience as well."

http://well.blogs.nytimes.com/2013/07/11/doctors-badmouthing-other-doctors/?hpw&pagewanted=print

Playing, and Losing, as a Medical Team - NYTimes.com

One of my patients died last month, a man I was particularly fond of. I had known him for almost 20 years. I had come to know his wife in person, the children in his frequently exasperated anecdotes and his grandchildren in blurry cellphone photos. His wife left a message with the unexpected news on a Monday morning.

It took me almost two weeks to get back to her.

How typical, right? The doctor shrugs and moves on. The doctor forgets the symbolic value of closure. The doctor doesn't bother to show up at the funeral. The doctor ignores the obligations that endure after the patient passes.

But hold your judgments. I called Lenny's wife back promptly, repeatedly, leaving increasingly puzzled messages and never getting a response.

I suppose you could call it all a medical error. But it wasn't mine.

Medicine has become a team sport — that's old news. Everyone knows that the team now includes residents, physician assistants, nurse practitioners, therapists, all taking over portions of the role that once belonged to the doctor alone.

These colleagues slice and dice the doctor's time-honored obligations into fragments that can be difficult to reassemble. Residents routinely use my license number to write prescriptions; if the resident makes a big mistake, who is liable? Nurses inject medications per my orders; if I miscalculate a dose and disaster ensues, who pays?

These days, that's not the end of it, not by a long shot. Behind the medical team stands an increasingly large backfield, giant in numbers, humble in training. They answer the phones, arrange consultations, organize the billing, deal with the unrelenting demands of dozens of insurers. Say that a secretary, a pleasant, overworked person sitting with her colleagues in an airless back office, each fielding dozens of calls a day — say she forgets to confirm a phone number scrawled into the medical record long ago. Who is responsible?

You won't find the answer in the ethics textbooks. Experts continue to talk about the "physican-patient relationship," that storied historic and fiduciary entity, as if it were still composed of mutual trust and obligations between two people. They haven't noticed that those two people have turned into a crowd.

Lenny was impossible, the best and the worst kind of patient. He never complained, mostly because he minimized half his problems and overlooked the rest. He vastly preferred to ignore his health and discuss his latest computer acquisitions. We spent a lot of office time on Apple vs. Microsoft. Whose fault was that?

In the long run, it hardly matters. He died at 52 in an emergency room from overwhelming staphylococcal sepsis, a treatable bacterial infection undoubtedly worsened by his chronic liver diseaseand his chronic denial — and by the impressive personal magnetism that endured to the end: Evidently he refused to let anyone call an ambulance till far too late.

Many things can go wrong in health care. These days more and more of them have nothing to do with actual health care. People leave a competent doctor for a marginal one because the first has a receptionist with a nasty disposition and the second has one who smiles. People change medications from good to not so good because their insurer pays for one set and not the other. People get their doctor on the phone right away because a secretary has the nerve to transfer the call to the staff lounge. People never hear from their doctor because a secretary forgets to confirm a phone number.

After 10 days with no word from Lenny's wife, I was beside myself. I couldn't leave any more messages. I couldn't fathom why she wasn't calling me back. I figured she was angry with me. So, of course, I got a little angry about that. Does everything have to be my fault? Then I remembered that I knew where she got her own medical care, at an office bound to have more contact information.

Sure enough: I had been calling the wrong number the whole time, off by one digit.

Two conversations end this story. The first one, between me and our secretary, was brief. There wasn't much to say. I am not her supervisor. Mistakes happen. She didn't know Lenny; she seldom gets out from the back room to see our world — hers as much as mine — in all its dimensions.

Then Lenny's wife and I talked for a long time. The edge in her voice eventually softened. We agreed that he had been impossible, and would be grievously missed. I told her I would have been at the funeral, if I had only known, and that I would never forget I had missed it.

http://mobile.nytimes.com/blogs/well/2013/07/08/playing-and-losing-as-a-medical-team/