Category Archives: Studies

Drugs remain on market despite fraudulent research; FDA withholds information

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

Despite concluding that a drug research lab’s violations “were so ‘egregious,’ and pervasive that studies conducted there between April 2005 and August 2009 might be worthless,” the FDA didn’t pull the drugs tested there from the market, according to a ProPublica piece by Rob Garver and Charles Seife.

pills

Photo by Grumpy-Puddin via Flickr

The FDA is refusing to release information about those drugs, saying that “We believe that this did not rise to the level where the public should be notified.”

A statement from the agency said, “The issue is not a lack of transparency but rather the difficulty of explaining why the problems we identified at Cetero, which on their face would appear to be highly significant in terms of patient risk, fortunately were not.” Continue reading

Was a study of chelation fatally flawed or just countercultural?

Brenda Goodman

About Brenda Goodman

Brenda Goodman (@GoodmanBrenda), an Atlanta-based freelancer, is AHCJ’s topic leader on medical studies, curating related material at healthjournalism.org. She welcomes questions and suggestions on medical study resources and tip sheets at brenda@healthjournalism.org.

This is the second of two posts about a study of whether chelation therapy might benefit some patients who have suffered a heart attack. In the first post, I gave health reporters high marks for their coverage.

Early in my career, I covered a story on chelation therapy. It was the first time I’d ever heard of the alternative treatment. I was a broadcast producer, and we needed video, so we visited a chelation clinic. Looking back, I can’t recall what our story was about, but I do remember what it was like to talk to the patients as they sat in recliners that lined the walls of the narrow storefront.

They were all hooked up to IV bags filled with a vivid yellow liquid that was a mixture of B-vitamins and the chemical EDTA that they believed was flushing heavy metals, minerals, and toxins from their bodies.

Many spoke of chelation with fervor. One man, a diabetic, credited the regular three-hour infusions with saving his legs, which were riddled with sores.

Chelation has been around for decades. It is accepted treatment for lead poisoning and other kinds of heavy metal toxicity. But alternative practitioners have greatly expanded its use, with claims that it can treat myriad ills, everything from autism to Alzheimer’s to problems caused by metal hip implants.  There’s almost no scientific evidence to back up these claims.

It was against this backdrop – lots of claims, enthusiastic patients, evangelistic providers – that the NIH set out to test the practice.

The Trial to Assess Chelation Therapy, or TACT, has again ignited a heated debate among doctors.

Here’s another voice to add to the discussion. He is lead study author Gervasio A. Lamas, M.D., chairman of medicine at Mount Sinai Medical Center in Miami Beach, Fla., and professor of clinical medicine at Columbia University Division of Cardiology. I asked him to talk about the process of publishing TACT and asked him to respond to a few of the main criticisms of the trial. These are lightly edited questions and answers from our interview: Continue reading

Researchers share work on regeneration, reconstruction #ahcj13

Alma Martinez

About Alma Martinez

Alma Martinez is a associate producer at Radio Bilingue in Fresno, Calif. She is attending Health Journalism 2013 on an AHCJ-Ethnic Media Health Journalism Fellowship, which is supported by the Leona M. & Harry B. Helmsley Charitable Trust.

In a Health Journalism 2013 panel focused on research taking place in regenerative medicine, Dany Adams, Ph.D., an associate research fellow at Tufts University, described her research with African frogs.

Through her research with bioelectricity, or electrical signals, she has proven that African clawed frogs can regenerate tails. She added that this particular species of frogs was a good candidate for the research, as the regeneration happens with a minimum risk of infection. What was most surprising when it came to the tail regeneration in the African clawed frogs is that the muscle, skeleton and spinal cord regenerated on their own, without the need of any additional therapies. She also shared that children can re-grow finger tips before the age of 10.

Adams said the possible implications for human benefits are great and implored journalists to cover such research so the public and legislators, who decide on funding for the continuation of such research, know about it. Continue reading

Stem cells: Hope or hype? #ahcj13

Lisa Krieger

About Lisa Krieger

Lisa Krieger is a science and medicine writer at the San Jose Mercury News. She is attending Health Journalism 2013 on an AHCJ-California Health Journalism Fellowship, which is supported by The California HealthCare Foundation.

The public’s hope for stem cell cures remain high, but scientists warn that many basic problems with this approach remain to be solved – and that investors demand profits far faster than research can be finished.

“We’ve created a system that is unrealistic and short sighted,” said Dr. Darrell Kotton, director of Center for Regenerative Medicine at Boston University’s Boston Medical Center.

Few of the 38 publicly traded stem cell companies will survive, said Philip Reilly, a physician, attorney and venture partner with Third Rock Ventures.

It is very difficult to produce returns in “venture time,” defined as less than five years, said Reilly. “There is tremendous disconnect,” between investors and biologists’ timelines, he said.

The best strategy, he believes, is for a small company to show data with enough promise – what he called “an inflection point” – that it wins the interest of a larger company, with the resources to carry the research across the finish line.

“Few will make it,” he said, of existing companies. At almost all, the cost per share has fallen below the opening price. “They were launched too soon.” Continue reading

Don’t fudge the facts on chocolate studies

Brenda Goodman

About Brenda Goodman

Brenda Goodman (@GoodmanBrenda), an Atlanta-based freelancer, is AHCJ’s topic leader on medical studies, curating related material at healthjournalism.org. She welcomes questions and suggestions on medical study resources and tip sheets at brenda@healthjournalism.org.

Studies that support a link between chocolate and good health are popular with readers. But the reality is that most chocolate studies are observational in nature and are therefore limited in what they can tell us about its supposed benefits.

Photo by “Nikita!” at Flickr.com.

Skilled health reporters use these kinds of studies as opportunities to gently educate readers about the limits of observational research, such as confounders. Read on for tips on recognizing confounding, factors that confuse or obscure the association between a primary exposure of interest and an outcome, and explaining it to your readers, viewers and listeners.
Here’s a recent case in point—a study published in Neurology called “Chocolate Consumption and Risk of Stroke.”

The study followed 37,000 men in Sweden for 10 years. That’s a plus. Bigger numbers and longer follow-up usually mean more reliable results.

At the start of the study, researchers asked the men to recall how much chocolate they’d eaten in the previous year. That’s the first problem with the study. People are bad at remembering what they eat. It’s called self-report bias. There’s a concise and well-sourced discussion of this major flaw in nutrition studies at the website Unite for Sight.

Based on that one measure, the men were divided into four groups that ranged from those who reported eating no chocolate to those who ate the most, about 63 grams a week. That’s about the size of one-and-a-half regular Hershey bars. They used hospital discharge records to confirm stokes. That was also a strength of the study. Because the Swedish health system keeps extensive medical records on its citizens, it’s unlikely that many strokes went uncounted.

Brenda GoodmanBrenda Goodman, AHCJ’s topic leader on medical studies, is writing blog posts, editing tip sheets and articles and gathering resources to help our members cover medical research.

If you have questions or suggestions for future resources on the topic, please send them to brenda@healthjournalism.org.

Over the next 10 years, 1,995 men – about 5 percent of the study population – had a first stroke. The men who ate the most chocolate had a slightly lower risk of stroke compared to men who said they didn’t eat chocolate. That would all be pretty suggestive, except that a penchant for indulging a chocolate craving wasn’t the only way the men differed. The biggest chocolate consumers were also younger, more educated, less likely to smoke or have high blood pressure. They also reported eating more red meat, drinking more wine, and eating more fruits and vegetables. With the exception of eating a lot of red meat, those other things also reduce stroke risk. Those are called confounders because they confuse the effect of the exposure (chocolate) on the outcome (stroke).

Researchers adjusted their data to try to remove the influence of those factors. Adjustment is an important step, but it’s not perfect, as Gary Taubes explains in a post for Discover magazine’s Crux blog.

Here’s the table where researchers reported the adjustment (click to view full size):

Here’s a tip about confounding. Look at relative risks (RR) before (green arrow) and after (red arrow) adjustment for confounders for the total stroke numbers. If there’s little confounding in a study, those numbers should be very nearly the same. If they are different, that’s a good indication that confounding is a problem and that there are other factors influencing risk that weren’t measured. For an effect size that’s already small to begin with — just a 23 percent reduced relative risk – these relative risks shrink even more, to 17 percent for the men who ate the most chocolate. Keep in mind, that’s just the difference in relative risk. If 5 percent of the men had a stroke over the course of the study, a 17 percent reduction in that risk would reduce the absolute risk for having a stroke by about .8 percent.

Perhaps recognizing the limits of their own study, researchers took the work a step further and conducted a meta-analysis, a study of studies.  Meta-analyses are powerful tools for establishing the weight of evidence. But as Gary Schwitzer points out in AHCJ’s slim guide, “Covering Medical Research,” the quality of a meta-analysis depends on the quality of studies it includes. Two of the five studies included in the meta-analysis found associations between chocolate and stroke risk that were non-significant. All measured chocolate consumption by asking study participants to remember how much chocolate they ate and how often they ate it. There’s that self-report bias again.

When all the results were pooled, chocolate appeared to reduce the relative risk of stroke by 19 percent.  Reductions in absolute risk were not reported, but they probably look a lot less dramatic.

That’s a lot to try to explain to readers who are short on time and attention.  Here’s how Amy Norton handled it in her story for Reuters Health:

It starts with a deft lede:

Men who regularly indulge their taste for chocolate may have a somewhat decreased risk of suffering a stroke, according to a study out Wednesday.

That’s very different from saying that chocolate may reduce or could lower a man’s risk of having a stroke. The vast majority of stories used that approach, and while it’s not technically inaccurate, words like reduce and lower imply that chocolate is causing the stroke reduction, which is something the study simply doesn’t have the power to prove.

Norton goes on to give the study some context but also to explain why readers shouldn’t go on an immediate chocolate binge (at least not to prevent a stroke):

The study, published in the journal Neurology, is hardly the first to link chocolate to cardiovascular benefits. Several have suggested that chocolate fans have lower rates of certain risks for heart disease and stroke, like high blood pressure.

But those studies do not prove that chocolate is the reason. And the new one, funded by the Swedish Council for working Life and Social Research and the Swedish Research Council, doesn’t either, according to a neurologist not involved in the study.

Other things to like about this story include the use of independent researchers for comment, a discussion about flavonoids in chocolate and why scientists think they may benefit health, and numbers that reflect absolute as well as relative risks.

Goodman to guide journalists on covering medical studies

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

AHCJ is pleased to introduce independent journalist Brenda Goodman as the association’s topic leader on covering medical studies. Goodman, a health and science reporter for 15 years across a variety of platforms, will help guide journalists through the jargon-filled shorthand of science and research and enable them to translate the evidence into accurate information that their readers can grasp.

Brenda Goodman

Brenda Goodman

She will write tip sheets and background briefs, ask other journalists to share their experiences and she will curate lists of resources for journalists. Her blog posts for Covering Health will recognize important reporting on medical studies and offer journalists information about what to look for and what to steer clear of in their reporting. The “Covering Medical Studies” core topic joins AHCJ’s health reform, aging and oral health resources.

She will encourage and review suggestions from AHCJ members on what resources they need to cover medical studies and even consider the “beating hearts” behind the studies. In her introduction to the topic, Goodman writes: Continue reading

JAMA editor predicts embargoes will be up for discussion

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

This is a guest post by AHCJ board member and AP medical writer Carla K. Johnson, who leads AHCJ’s Chicago chapter.

Howard Bauchner, M.D., is editor of the Journal of the American Medical Association

Howard Bauchner, M.D., editor of the Journal of the American Medical Association discussed health care reform in light of the elections. (Photo: Carla K. Johnson)

Howard Bauchner, M.D., editor-in-chief of the Journal of the American Medical Association, spoke to about 25 journalists and students at a recent AHCJ Chicago chapter event hosted by JAMA at its Chicago office.

“I don’t think we’ve settled the debate in the United States about whether health care is a fundamental right or a fundamental privilege,” Bauchner said in response to a question about doctors’ views on the Affordable Care Act. “And it’s been striking to me that the president has avoided that issue.”

Bauchner added: “That goes to the heart about why physicians are very divided about it.”

Bauchner talked about embargoes, the debate over open access to medical research and the online integration of the 10 medical journals in the JAMA Network.

He said he expects embargoes to be discussed at the May retreat of the JAMA editorial board. He’ll bring the board information on what other journals are doing, he said, and he’ll pose the question, “How does audio and video change any notion that embargoes should exist?” He said he’ll seek opinions from journalists, too.

Chicago-area journalists gathered to hear from JAMA's editor. (Photo: Carla K. Johnson)

Chicago-area journalists gathered to hear from JAMA’s editor. (Photo: Carla K. Johnson)

Bauchner speculated: “We will continue to have embargoes. The exact, precise timing of it is a little less clear to me.”

During his discussion of embargoes, Bauchner wondered whether a certain blogger would get word of his comments.

“Who’s the embargo person who blogs all the time?” he asked.

Several voices in the audience chorused: “IVAN ORANSKY.”

Oransky is an AHCJ board member whose Embargo Watch blog keeps an eye on embargoes and how they affect news coverage.

The Chicago chapter thanks Jann Ingmire of the JAMA Network for her help organizing the event.

New and noteworthy tidbits on the aging and health care beat

Judith Graham

About Judith Graham

Judith Graham (@judith_graham), a Colorado-based freelancer, is AHCJ’s topic leader on aging, and as such curates related material at healthjournalism.org. She welcomes questions and suggestions on aging issue resources and tip sheets at judith@healthjournalism.org.

The Center for Budget and Policy Priorities has published a new report that looks at Social Security’s role in keeping Americans out of poverty.  Poverty is closely linked with compromised access to medical care and lesser health status.   Regarding older adults, the Center explains:

“Almost 90 percent of people aged 65 and older receive some of their family income from Social Security.[2]   Without Social Security benefits, 43.6 percent of elderly Americans would have incomes below the official poverty line, all else being equal; with Social Security benefits, only 8.7 percent do.  These benefits lift some 14.5 million elderly Americans — including 8.7 million women — above the poverty line.

Social Security reduces elderly poverty dramatically in every state in the nation, as Figure 1 and Table 2 show.  Without Social Security, the poverty rate for those aged 65 and over would meet or exceed 40 percent in 41 states; with Social Security, it is less than 10 percent in the large majority of states.”

The Scan Foundation has published a new issue brief on who provides long-term care in the United States.  Among the findings:

  •  The vast majority of people who need long-term care – 87 percent – receive services from informal or unpaid caregivers.
  • 43.5 million Americans serve as informal caregivers to adults age 50 and older.  Two-thirds of these caregivers are female.
  • For people who require assistance with activities of daily living, the most common types are getting in and out of bed (40 percent), getting dressed (32 percent) and bathing and showering (26 percent).
  • For people who need help with so-called instrumental activities of daily living, the most common types offered by a caregiver are transportation (83 percent) and housework and grocery shopping (both at 75 percent).
  • 70 percent to 80 percent of paid long-term care services are provided by direct care workers – certified nursing assistants, personal care aides, and home health aides.

AARP and New York’s United Hospital Fund document the extent to which family caregivers deal with complex medical needs of older relatives in a new report, Home Alone:  Family Caregivers Providing Complex Chronic Care.  It’s based on an online survey of more than 1,600 family caregivers.   Important findings include:

“Almost half (46 percent) of family caregivers performed medical/nursing tasks for care recipients with multiple chronic physical and cognitive conditions.

“These tasks include managing multiple medications, helping with assistive devices for mobility, preparing food for special diets, providing wound care, using monitors, managing incontinence, and operating specialized medical equipment.

“Family caregivers reported very few home visits by health care professionals. Sixty-nine percent of the care recipients did not have any home visits by health care professionals. Of those who did have home visits, roughly seven in ten were visited by a nurse.

“Most family caregivers who provided help with five or more medical/nursing tasks believed they were helping their family member avoid institutionalization. Those who provided these tasks and reported they had training were more likely to say they were able to help their family member avoid nursing home placement.

“These significant relationships are important on both the individual and public policy levels.”

AARP’s Public Policy Institute also  has published a new issue brief that looks at the impact of family caregiving on work.  Of note:

“An estimated 61 percent of family caregivers of adults age 50 and older are currently employed either full-time (50 percent) or part-time (11 percent).”

“Forty-two percent of U.S. workers have provided care for an aging relative or friend in the past five years. About half (49 percent) of the workforce expects to be providing eldercare in the coming five years.”

“In 2011, 17 percent of workers in the United States provided eldercare,5-7 up from 13 percent in 1999.”

If you’ve seen other reports or issue briefs on aging that deserve wide circulation, drop a line below and let us know.

Calorie restriction stories highlight best practices when writing about research

Judith Graham

About Judith Graham

Judith Graham (@judith_graham), a Colorado-based freelancer, is AHCJ’s topic leader on aging, and as such curates related material at healthjournalism.org. She welcomes questions and suggestions on aging issue resources and tip sheets at judith@healthjournalism.org.

Down crashed one of the great hopes of anti-aging medicine recently with the news that calorie restriction did not lift longevity in rhesus monkeys.

Core Topics
Health Reform
Aging
Oral Health
Other Topics

It was a surprising finding, as Sharon Begley of Reuters reported in an elegantly written, nicely balanced story.

In 2006, a separate study of starvation-level diets in close-but-you’re-not-quite-family primates had indicated that monkeys were less likely to get “heart disease, diabetes, cancer and other diseases of aging” after abstaining from normal eating for 20 years.

As Begley notes:

“They also lived longer: By 2009, 80 percent of the free-eating Wisconsin monkeys had died of age-related illness, but only 50 percent of calorie-restricted monkeys had. Those findings, the scientists reported at the time, showed “that CR slows aging in a primate species.”

Also, earlier research had confirmed that lab rats, mice, yeast, fruit flies and round worms fed up to 40 percent less than normal lived 30 percent longer, and sometimes even more, Begley observes.

So, hopes were running high and negative findings from the new National Institute on Aging study were not expected.
Continue reading

Survey: Cost keeps Americans from visiting dentists

Mary Otto

About Mary Otto

Mary Otto, a Washington, D.C.-based freelancer, is AHCJ's topic leader on oral health, curating related material at healthjournalism.org. She welcomes questions and suggestions on oral health resources at mary@healthjournalism.org.

Three-quarters of American adults say they have good or very good oral health.

The news is not so good for the other 25 percent, according to newly released statistics from the Centers for Disease Control and Prevention.

Mary OttoMary Otto, AHCJ’s topic leader on oral health, is writing blog posts, editing tip sheets and articles and gathering resources to help our members cover oral health care. If you have questions or suggestions for future resources on the topic, please send them to mary@healthjournalism.org.

Seventeen percent report their oral health is only fair and 7 percent say they have poor oral health. The findings, contained in a new report, were gathered as part of the 2008 annual National Health Interview Survey, based upon face-to-face interviews with more than 17,000 men and women aged 18 to 64.

According to the survey findings, adults with Medicaid (21 percent) were almost twice as likely as adults overall (12 percent) to have not had a dental visit in more than five years.

The main reason for forgoing a dental visit for an oral health problem in the past six months was cost, respondents said. A full 42 percent told interviewers they could not afford treatment or did not have insurance.

Adults with Medicaid were almost five times as likely as adults with private health insurance to report poor oral health. And this was in 2008. As the effects of the recession wore on, Medicaid enrollment swelled. To contain costs, many states began cutting even the often meager adult dental benefits they carried, the Kaiser Commission on Medicaid and the Uninsured found. Continue reading