New data from an ancillary study of the Women’s Health Initiative (WHI) links hormone-replacement therapy to dementia and memory loss in women 65 years and older. These results, which were published in the January 13, 2009 issue of the journal Neurology, come from the Women’s Health Initiative Memory Study, or WHIMS for short. This trial examined about 1,400 postmenopausal women from 14 different sites who received brain MRI scans to determine the effects of hormone therapy on cognition and memory.
Previous results from the larger WHI study suggested that hormone-replacement therapy may adversely affect memory and cognition in women aged 65 and older by possibly increasing the number of “silent strokes” and brain lesions. However, these latest results showed that it is a loss of brain volume rather than the presence of brain lesions that causes memory loss and cognitive impairment in older postmenopausal women. In fact, investigators found that the total volume of brain tissue in those regions of the brain associated with memory was actually smaller in postmenopausal women who had used hormone-replacement therapy compared with those who did not use hormones.
Keep in mind that loss of brain tissue naturally occurs to all of us as we age. However, these results suggest that hormone-replacement therapy may increase the rate at which this loss occurs in women 65 years or older. It’s important to remember that the women who participated in this trial were all 65 years or older; thus, the results cannot be extrapolated to younger women.
New Data on the Impact of Medical Errors on Health Care Costs and Outcomes
Investigators for the Agency for Healthcare Research and Quality (AHRQ) released the results of a study that examined medical errors that occur during or after surgery. Impact of medical errors on 90-day costs and outcomes: an examination of surgical patients by Dr. William Encinosa and Dr. Fred Hellinger examined data from a national sample of more than 161,000 patients between the ages of 18 and 64 with employer-sponsored health insurance who had surgery between 2001 and 2002.
The results show that insurers paid 52% more for surgery patients who experienced acute respiratory failure and 48% more for those who developed postoperative infections compared with patients who experienced neither of these conditions during or following surgery. Other medical errors that increased costs included:
You can request reprints of the report (AHRQ publication number 08-R079) from the AHRQ Clearinghouse at 800-358-9295. To order online, send an email request to ahrqpubs@ahrq.hhs.gov
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New Changes to Recommendations for Screening Hearing Loss in Newborns
Here’s new information for writers developing content in the field of infant and child development. In July 2008 the US Preventive Services Task Force released revised recommendations for screening hearing loss in newborns. The new guidelines recommend that all newborn infants be screened for congenital hearing loss before they are 1 month old using a 2-step screening process. The task force recommends that all infants first be tested using a measure called otoacoustic emissions. If infants fail this test, they should be tested using auditory brainstem response (ABR). Such so-called universal screening would be helpful in identifying infants who have hearing loss but no risk factors. Early identification of hearing loss is necessary so that treatment can be initiated as early as possible.
As of September 2008, 39 states have some kind of legislation related to screening hearing in newborns. The laws vary from state to state, however, with some states mandating universal hearing screening while others merely encourage the process.
To read more about the revised recommendations and to obtain materials, go to http://www.ahrq.gov/clinic/uspstf/uspsnbhr.htm.
You can learn more about how to detect hearing problems in infants and children at the website of the American Speech-Language-Hearing Association at http://www.asha.org/.
The US Preventive Services Task Force is an independent panel of experts that makes recommendations with regard to prevention and primary care.
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Medical Writers in the Crosshairs
Once again, the issue of the use of medical writers who work with physician authors to develop manuscripts for publication in medical journals rears its head in the media, in an article published in the December 12, 2008 issue of the New York Times and in an article published in the December 13, 2008 issue of Wall Street Journal.
The articles cite an investigation by Senator Charles E. Grassley into whether pharmaceutical giant Wyeth recruited and paid physicians to put their names on journal manuscripts that were already written. This particular situation is just one part of an ongoing investigation by Senator Grassley, a member of the Senate Finance Committee who is trying to determine what, if any, influence the pharmaceutical industry has on physicians.
An unfortunate consequence of this article is the naming of a reputable medical communications firm, whom Wyeth hired to assist with the creation and placement of these journal manuscripts and, indirectly, the suggestion that such firms—and the medical writers they hire—inherently engage in unethical practices when crafting manuscripts.
While we recognize that pharmaceutical companies are in business to make money, the suggestion that medical writers and medical communications firms are inherently unethical couldn’t be farther from the truth. Have questionable and possibly deceptive practices taken place in the past? We’re sure they have. As we write in our book, The Accidental Medical Writer, once upon a time, it was perfectly acceptable to keep the contribution of medical writers invisible. More recently, we’re pleased to report, the contribution of medical writers has begun to come out of the shadows and be rightfully acknowledged. Of course, with this acknowledgement comes responsibility—including the responsibility of medical writers and others who contribute substantially to the content of a manuscript, to report any potential conflicts of interest. Today, medical writers and medical communications firms must adhere to strict guidelines when it comes to creating journal articles that report on the outcomes of clinical trials that will appear in reputable medical journals.
An unspoken issue here that has been overlooked relates to the skills needed to write an accurate yet readable manuscript. Writing is a skill, one that some folks have innately, but one that others must learn. Writers know how to write; physicians know how to diagnose and manage diseases. As writers, we must have a solid understanding of the science behind what we are writing, but we rely on the expertise of the physicians with whom we work to direct us and keep us on track. Likewise, physicians must have a solid understanding of what they want to communicate, but they rely on medical writers to construct informative and understandable prose. It can no more be assumed that a physician can write than that a teacher can cook. Medicine and writing are separate skills with separate prerequisites.
Every pharmaceutical company has a medical writing department with writers who create documents to very precise standards. Medical communications firms exist to assist pharmaceutical companies with those tasks. Such medical writers are skilled at organizing medical information and making complex scientific information readable and understandable. In the same vein, pharmaceutical companies hire statisticians to crunch the results of clinical trials and identify significant trends and outcomes. We’ve never understood why it’s perfectly acceptable to use statisticians to assist physicians in the content of their manuscripts, but unacceptable to use a medical writer to assist physicians in putting their thoughts coherently on paper.
Let’s not allow the valuable contributions of medical writers to be thrashed in this controversy. Instead, let’s use this as an opportunity to advance the call for all medical writers who are involved in the development of manuscripts for publication in medical journals to be acknowledged for their contributions and held to the same standards of quality and ethics as physician authors. For more information on this subject, check out the AMWA Position Statement on the Contributions of Medical Writers to Scientific Publications (AMWAJ), which is available at http://www.amwa.org.
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