Saturday, August 8, 2009

Pulse + Signal — Highlighting New Ideas and Innovation in Public Health

How did I come up with this name? Well…

Pulse = Life, Health, "what keeps you going"

Signal= Technology, standing out, a prompt to action

This little corner of the web will feature commentary on the impact and potential usefulness, of technology (e.g. social media, mobile/emerging web tech) on health communication, health education and social marketing. I have a passion for making sure that as many people as possible are informed about the choices they have regarding their health. In this new era of user-generated content, spectacular technology and Web 2.0 tools, we're at a great place where we can help change lives for the better on both small and large scales; and health is one of those areas ripe for change.

Pulse + Signal also aims to equip public health professionals with the understanding of these new tools and how they can be useful for crafting meaningful campaigns and being effective with their target audiences. The way I see it, the more empowered these individuals are with their work, the better they can inform this nation and beyond, on healthier living.

We are living in times where we can no longer rely on the government or other handouts to better our health – it's up to us to make that change for a better tomorrow. I want to make sure that the public health world embrace these new dynamics and use them in every way possible to impact lives.

Clinical Trials, Wrapped in Red Tape -

It's Christmas in August for hopeful scientists. The National Institutes of Health is now sending out its annual "priority scores," the indicators of whether grant requests will likely receive financing from the agency. And hearts are beating faster than ever, as the federal stimulus package has poured an additional $8.2 billion into the institutes' budget specifically for research.

However, for those grant-winners whose studies will involve human volunteers, another big hurdle remains: federal ethics regulations. No one denies the need to shield human subjects from undue risk. But current regulations have become so stringent and unwieldy that the ethics oversight system often impedes the kind of careful research we should be promoting. As two highly regarded medical ethicists, Dr. Norman Fost of the University of Wisconsin and Dr. Robert J. Levine of Yale, put it in the Journal of the American Medical Association, the system regulating the use of human subjects is "increasingly dysfunctional."

This sort of dysfunction was on display last year after the Office for Human Research Protections, a regulatory branch of the Department of Health and Human Services, halted a University of Michigan study of a simple five-step checklist to prevent infections at health centers. The checklist merely routinized procedures that should be performed anyway, including washing hands with soap and cleaning a patient's skin with antiseptic. But because researchers intended to assess the checklist's success, their work met the strict definition of "research," and thus required patients' informed consent. Because they had never obtained it, the human research office shut the study down.

Fortunately, the Michigan incident generated enough outcry among scientists, physicians and the public that the agency reversed itself a few weeks later. But in this, it was the exception rather than the rule.

At medical schools and other research facilities, scientists using human subjects seek approval from institutional review boards, which enforce compliance with federal regulations on risk, informed consent and subject confidentiality. Although some boards are flexible, many are too risk-averse, narrowly interpreting each word in research protocols lest they be second-guessed by Washington regulators.

Some scientists deliberately design their studies more conservatively than they would like in order to placate fastidious review boards. Onerous paperwork regularly delays projects for months and inflates costs. A report last year in the journal Science warned that such paperwork is at "risk of pricing large clinical trials out of reach."

Large trials are often spread across many medical centers — each with its own review board. Before a 43-center study of hypertension could begin at Veterans Affairs medical centers, for example, a year and a half was spent getting all 43 boards to approve the same protocol. Each time a single board required a change to the protocol, the others had to review it and agree as well.

Stanford University researchers have estimated that it cost them about $56,000 in administrative wages, 18 months of delay and 10,000 pages of paper to make a small change to an already-approved research program that simply compared the progress made by patients attending different types of addiction-treatment programs.

The lengthy approval process cuts into scientific productivity. David Dilts, the director of clinical research at the Knight Cancer Institute in Oregon, found that 30 percent of all board-approved oncology trials are eventually abandoned.

To circumvent overbearing federal boards, researchers occasionally turn to for-profit independent review boards to approve their studies. These boards cost less and work quickly, but some have dangerously lax standards. This spring the Government Accountability Office announced that it had submitted a fabricated study of a fake surgical adhesive gel called Adhesiabloc to an independent review board, which approved the protocol by unanimous vote, saying the "gel is probably very safe."

Even if a study gets approval from an institutional review board, it's not clear that the subjects are all that protected. The consent forms may run to dozens of pages written in dense legalese. Thus they provide legal cover for the research institutions, but do little to inform subjects.

And some efforts to protect subjects veer into a sort of bureaucratic paternalism. After 9/11, mental health researchers' efforts to get timely access to disaster victims was thwarted by review boards concerned that subjects would be "re-traumatized" by filling out questionnaires. Many review boards insist that subjects may be "coerced" into participating in a study if offered a token gratuity of, say, $25.

By late fall, the lucky grant winners are expected to have their studies up and running. But before volunteers can participate, the protocols must gain review board approval. With probably more studies than ever looking for a green light, researchers are preparing for a bottleneck. Clearly, the oversight system has fallen short of the ethical standard it purports to uphold: that the benefits of medical research exceed the costs.

Sally Satel, a psychiatrist and resident scholar at the American Enterprise Institute, is the editor of "When Altruism Isn't Enough: The Case for Compensating Kidney Donors."

Friday, August 7, 2009

Are Patients in Part to Blame When Doctors Miss the Diagnosis? -

Marla (not her real name) came to our clinic with breast cancer. The clinic nurse stopped me before I went into Marla's exam room. "She's different," the nurse whispered to me. "The last doctor just threw up his hands."

In her 40s, with long blonde braids and blue eyes, Marla dressed in flowing robes, as if she had just walked off the set of "A Midsummer's Night Dream." She smiled and spoke softly as she answered my initial questions but became more animated when she began to describe her lifestyle and the kinds of herbal supplements she took.

It turned out that Marla was like my mother, a preventive health and alternative medicine enthusiast. When Marla heard that I, as a child, had choked down bowls of pungent, muddy brew boiled up from unrecognizable Chinese herbs and shriveled animal parts, she laughed so hard that tears welled up in her eyes. She had served similar concoctions to her loving but apparently long-suffering husband.

But throughout our conversation, I noticed that despite her laughter, Marla never moved. She sat stiffly, hunched over and cocked slightly to the left, with her left arm bent against her chest, as if cradling a baby.

Two years earlier, Marla had noticed a pebble-sized lump in her left breast. Her primary care physician scheduled her for a mammogram, but Marla wanted first to try alternative remedies, so she skipped the appointment. She never went back to see her doctor because she felt that as soon as she began talking about other treatment options, he "shut down. "

Months later, when it became clear that the mass was growing and not shrinking, her husband suggested she see a surgeon. "I thought I could take care of it," she said to me, recalling the sequence of events, "but I guess not."

Little could have prepared me for what I saw when Marla opened her gown. While the right side of her chest was unremarkable, her left breast was the size of a young child's head. The skin was stretched thin, and I could see an outline of the tumor within. That tumor was so large and so heavy that it seemed to pull the rest of her body down. Marla hunched over oddly and cradled her left arm not out of habit but to support the weight of the cancer within her breast.

We admitted Marla immediately to the hospital and removed her cancer the next day. Fortunately, the tumor was not an aggressive one, but her operation was far more extensive and fraught with risks than it would have been two years earlier. And as much as I liked Marla personally and enjoyed our conversations, I was also frustrated that she hadn't come forth sooner with some doctor about her cancer.

Marla was not the first patient I had seen who had waited until her cancer was advanced before seeing the doctor. But I have learned over the years that while my initial reaction is always to question if I or any other doctor missed the diagnosis, the situation is not always so cut and dry. While I need to understand and respect the beliefs of my patients, I still can't escape feeling a certain level of responsibility as a doctor. I find myself wondering when it comes to patients like Marla or others whose diagnoses are delayed for various personal, social and economic reasons, how responsible am I as the physician and are they as the patients?

Diagnostic failures, or diagnoses that are delayed or in error, are an increasingly popular topic of research in patient safety. While some researchers have focused on the role of doctors — are there flaws in the way they think? are "gut reactions" reliable? — others have looked at the steps involved in care, or the process of care. What has emerged most recently from this latter group of studies is that diagnostic failures are often due to missed steps, so-called "process of care lapses," that stem from both doctors and patients.

In the June issue of The Journal of General Internal Medicine, for example, investigators from Harvard Medical School studied the records of over 100 women with breast cancer diagnosed late or at advanced stages and found that roughly a quarter of patients had experienced process of care lapses. Examples of such lapses included inadequate physical exams, delayed physician involvement and incomplete diagnostic and laboratory tests. But while the investigators discovered that nearly 20 percent of the women were missing as many as two or more steps in their care, they also found that doctors and patients contributed equally to the resulting diagnostic failures.

"Clearly we found that about half of the process failures were due to something the patient did," said Dr. Saul N. Weingart, lead author of the study and a practicing internist and vice-president of Quality Improvement and Patient Safety at the Dana-Farber Cancer Institute in Boston. "These patients missed their mammogram appointments or never went to see the specialists their primary care physicians had recommended."

To address these lapses, experts in the field of patient safety like Dr. Weingart have proposed a variety of strategies to strengthen patient follow-up. One strategy that many physicians already use in one form or another is a "tickler system," electronic or paper reminders to check that diagnostic testing or referrals are completed. Other ways include implementing a type of technology that allows physicians to check specific tests across their entire practice, or panel, on a monthly basis. With "the push of a button," a doctor can see which patients have not yet followed through, for example, on their mammogram appointments.

And perhaps just as important as any technological change is one that involves transforming deep-rooted practice patterns. "It's not part of practices now," Dr. Weingart said, "but you can imagine creating an expectation among the medical community where if patients don't go, the referring doctors or practices will notify you."

But there are hidden obstacles in care as well. When Dr. Weingart and his co-investigators looked more closely at the group of individuals who had experienced lapses, they found that many were patients who were particularly vulnerable: they were minorities, possessed less education and came from challenging socioeconomic backgrounds, all of which contributed to practical obstacles or poor health literacy.

These findings "suggest that there are some intangible barriers," Dr. Weingart remarked. "Perhaps these patients don't know how to access care, need an interpreter, live farther away, or may be overwhelmed by family responsibilities. All of these factors are distractions for a patient and make getting care all that much harder."

In order to address these intangible barriers, Dr. Weingart suggested that "we need to develop not only risk assessment tools but also services geared toward patient vulnerabilities." But given that many physician practices, particularly those in the community, are already overstretched, organizing and maintaining such services may be close to or simply impossible. "Often when I talk to community practices about these findings," Dr. Weingart added, "the doctors will tell me that they can only do so much. When a patient doesn't show up, do I have to track him or her down? How many letters do I have to send the patient? What constitutes due diligence?"

How much responsibility, then, do doctors — and patients — bear in diagnostic failures?

"I don't think it's 50-50," Dr. Weingart reflected, "and I also don't think it's 100-zero. I think there's a shared responsibility. But given that the patients who fall through the cracks are usually the least resourceful and most vulnerable, there is at least a moral obligation for clinicians and health care systems to provide a robust safety net for these patients.

"I think we physicians need to support patient responsibility, but we also need to get our own house in order first. In terms of process failures, we need to make sure that the current system under health care providers is airtight. After we get that figured out, we then need to think about ways to help our patients do what they need to do."

Wednesday, August 5, 2009

Ghostwriters Paid by Wyeth Aided Its Drugs -

Newly unveiled court documents show that ghostwriters paid by a
pharmaceutical company played a major role in producing 26 scientific
papers backing the use of hormone replacement therapy in women,
suggesting that the level of hidden industry influence on medical
literature is broader than previously known.

The articles, published in medical journals between 1998 and 2005,
emphasized the benefits and de-emphasized the risks of taking
hormones to protect against maladies like aging skin, heart disease
and dementia. That supposed medical consensus benefited Wyeth, the
pharmaceutical company that paid a medical communications firm to
draft the papers, as sales of its hormone drugs, called Premarin and
Prempro, soared to nearly $2 billion in 2001.
But the seeming consensus fell apart in 2002 when a huge federal
study on hormone therapy was stopped after researchers found that
menopausal women who took certain hormones had an increased risk of
invasive breast cancer, heart disease and stroke. A later study found
that hormones increased the risk of dementia in older patients.

The ghostwritten papers were typically review articles, in which an
author weighs a large body of medical research and offers a bottom-
line judgment about how to treat a particular ailment. The articles
appeared in 18 medical journals, including The American Journal of
Obstetrics and Gynecology and The International Journal of Cardiology.

The articles did not disclose Wyeth's role in initiating and paying
for the work. Elsevier, the publisher of some of the journals, said
it was disturbed by the allegations of ghostwriting and would

The documents on ghostwriting were uncovered by lawyers suing Wyeth
and were made public after a request in court from PLoS Medicine, a
medical journal from the Public Library of Science, and The New York

A spokesman for Wyeth said that the articles were scientifically
accurate and that pharmaceutical companies routinely hired medical
writing companies to assist authors in drafting manuscripts.

More ...

Monday, August 3, 2009

Forty Years' War - Lack of Study Volunteers Hobbles Cancer Fight

Not long ago, at a meeting of an advisory group established by
Congress to monitor the war on cancer, participants were asked how to
speed progress.

"Everyone was talking about expanding the cancer work force and
getting people to stop smoking," said Dr. Scott Ramsey, a cancer
researcher and health economist, who was participating in that
January 2008 meeting of the President's Cancer Panel. "Lots of
murmurs of approval."
Then it was his turn.

The biggest barrier, in his opinion, was that almost no adult cancer
patients — just 3 percent — participate in studies of cancer
treatments, mostly new drugs or drug regimens.

"To me it was obvious," Dr. Ramsey said. "We can't improve survival
unless we test new treatments against established ones."

The room fell silent.

"It was one of those embarrassing moments," said Dr. Ramsey, an
associate professor at the Fred Hutchinson Cancer Center in Seattle.
He had brought up the subject he said no one wanted to touch.

Forty years after President Richard M. Nixon declared war on cancer,
death rates have barely changed. "Why aren't we getting cures?" Dr.
Ramsey said. "This is one of the biggest reasons."

More ...

Divorce, It Seems, Can Make You Ill -

Married people tend to be healthier than single people. But what happens when a marriage ends?

New research shows that when married people become single again, whether by divorce or a spouse's death, they experience much more than an emotional loss. Often they suffer a decline in physical health from which they never fully recover, even if they remarry.

And in terms of health, it's not better to have married and lost than never to have married at all. Middle-age people who never married have fewer chronic health problems than those who were divorced or widowed.

The findings, from a national study of 8,652 men and women in their 50s and early 60s, suggest that the physical stress of marital loss continues long after the emotional wounds have healed. While this does not mean that people should stay married at all costs, it does show that marital history is an important indicator of health, and that the newly single need to be especially vigilant about stress management and exercise, even if they remarry.

More ...

Sunday, August 2, 2009

Obesity a key link to soaring health tab as costs double

As Congress searches for ways to control health care costs, a new report provides a sizable target: obesity.

Americans who are 30 or more pounds over a healthy weight cost the country an estimated $147 billion in weight-related medical bills in 2008, double the amount a decade ago, according to a study by government scientists and the non-profit research group RTI International.

Obesity now accounts for 9.1% of all medical spending, up from 6.5% in 1998. Overall, an obese patient has $4,871 in medical bills a year compared with $3,442 for a patient at a healthy weight.

"Obesity is the single biggest reason for the increase in health care costs," says Eric Finkelstein, a health economist with RTI and lead researcher on the new study. "If you really want to rein in health care dollars, you have to get people dieting, exercising and living a healthier lifestyle. Otherwise somebody is going to be paying for treating these weight-related illnesses."

More ...