Health Technology Research Synopsis
22nd Issue Date 8 JAN 2008
Compiled By Ralph Turchiano
www.healthresearchreport.me www.vit.bz
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Editors Top Five:
1. The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States 2. Jefferson scientists studying the effects of high-dose vitamin C on non-Hodgkin lymphoma patients 3. 100% of people carry at least one type of pesticide from the air, water or food in their bodies 4. Treatment with NAC is associated with better outcomes for children with liver failure 5. US ranks last among other industrialized nations on preventable deathsIn this issue:
1. Researchers show that fibrosis can be stopped, cured and reversed 2. Silence may lead to phantom noises misinterpreted as tinnitus 3. The very old may benefit from L-carnitine 4. Environmental Trigger for Alzheimer’s Disease 5. New discovery could reduce the health risk of high-fat foods 6. The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States 7. Tips to prevent adverse drug events in older adults 8. Vitamin D2 is as effective as vitamin D3 in maintaining concentrations of 25-hydroxyvitamin D 9. Jefferson scientists studying the effects of high-dose vitamin C on non-Hodgkin lymphoma patients 10. Winemaking waste proves effective against disease-causing bacteria in early studies 11. The prevalence and impact of arthritis and other rheumatic conditions in the United States 12. Older surgical patients at greater risk for developing cognitive problems 13. 100% of people carry at least one type of pesticide from the air, water or food in their bodies 14. Strength training of neck muscles relieves chronic pain 15. Treatment with NAC is associated with better outcomes for children with liver failure 16. Pollution shrinks foetus size: Brisbane study finds 17. Lack of vitamin D may increase heart disease risk 18. Infants with Birthmarks Received Less Oxygen in Womb 19. Trichloroethylene is a risk factor for parkinsonism 20. US ranks last among other industrialized nations on preventable deaths 21. American women are more likely to choose overly aggressive treatments for breast cancer
Public release date: 26-Dec-2007
Researchers show that fibrosis can be stopped, cured and reversed
Modified protein developed by UC-San Diego researchers may lead to first cure for cirrhosis of the liver
University of California, San Diego researchers have proven in animal studies that fibrosis in the liver can be not only stopped, but reversed. Their discovery, to be published in PLoS Online on December 26, opens the door to treating and curing conditions that lead to excessive tissue scarring such as viral hepatitis, fatty liver disease, cirrhosis, pulmonary fibrosis, scleroderma and burns.
Six years ago, the UC San Diego School of Medicine research team discovered the cause of the excess fibrous tissue growth that leads to liver fibrosis and cirrhosis, and developed a way to block excess scar tissue in mice. At that time, the best hope seemed to be future development of a therapy that would prevent or stop damage in patients suffering from the excessive scarring related to liver or lung disease or severe burns.
In their current study, Martina Buck, Ph.D., assistant professor of medicine at UCSD and the Veterans Affairs San Diego Healthcare System, and Mario Chojkier, M.D., UCSD professor of medicine and liver specialist at the VA, show that by blocking a protein linked to overproduction of scar tissue, they can not only stop the progression of fibrosis in mice, but reverse some of the cell damage that already occurred.
In response to liver injury – for example, cirrhosis caused by alcohol – hepatic stellate cell (HSC) activated by oxidative stress results in large amounts of collagen. Collagen is necessary to heal wounds, but excessive collagen causes scars in tissues. In this paper, the researchers showed that activation of a protein called RSK results in HSC activation and is critical for the progression of liver fibrosis. They theorized that the RSK pathway would be a potential therapeutic target, and developed an RSK inhibitory peptide to block activation of RSK.
The scientists used mice with severe liver fibrosis – similar to the condition in humans with cirrhosis of the liver – that was induced by chronic treatment with a liver toxin known to cause liver damage. The animals, which continued on the liver toxin, were given the RSK-inhibitory peptide. The peptide inhibited RSK activation, which stopped the HSC from proliferating. The peptide also directly activated the caspase or “executioner” protein, which killed the cells producing liver cirrhosis but not the normal cells.
“All control mice had severe liver fibrosis, while all mice that received the RSK-inhibitory peptide had minimal or no liver fibrosis,” said Buck.
Buck explained that the excessive collagen response is blocked by the RSK-inhibitory peptide, but isn’t harmful to the liver. “The cells continue to do their normal, healing work but their excess proliferation is controlled,” Buck said. “Remarkably, the death of HSC may also allow recovery from liver injury and reversal of liver fibrosis.”
The researchers found a similar activation of RSK in activated HSC in humans with severe liver fibrosis but not in control livers, suggesting that this pathway is also relevant in human liver fibrosis. Liver biopsies from patients with liver fibrosis also showed activated RSK.
The study expands on work reported in 2001 in the journal Molecular Cell announcing that a team led by Buck had found that a small piece of an important regulatory protein called C/EBP beta was responsible for fibrous tissue growth, or excessive scar tissue following injury or illness. When normal scarring goes awry, excessive build-up of fibrous tissue can produce disfiguring scars or clog vital internal organs and lead to serious complications. Buck and colleagues developed a mutated protein that stopped this excessive fibrous tissue growth.
“Six years ago, we showed a way to prevent or stop the excessive scarring in animal models,” said Buck. “Our latest finding proves that we can actually reverse the damage.”
Worldwide, almost 800,000 people die from liver cirrhosis each year, and there is currently no treatment for it. Excessive tissue repair in chronic liver disease induced by viral, toxic, immunologic and metabolic disorders all result in excessive scar tissue, and could benefit from therapy developed from the UCSD researchers’ findings.
Public release date: 1-Jan-2008
Silence may lead to phantom noises misinterpreted as tinnitus
New research from the journal Otolaryngology — Head and Neck Surgery
Phantom noises, that mimic ringing in the ears associated with tinnitus, can be experienced by people with normal hearing in quiet situations, according to new research published in the January 2008 edition of Otolaryngology – Head and Neck Surgery.
The Brazilian study, which consisted of 66 people with normal hearing and no tinnitus, found that among subjects placed in a quiet environment where they were asked to focus on their hearing senses, 68 percent experienced phantom ringing noises similar to that of tinnitus. This is compared to only 45.5 percent of participants who heard phantom ringing when asked to focus on visual stimuli and not on their hearing, and 19.7 percent of those asked to focus on a task in a quiet environment.
The authors believe that these findings show that with regards to tinnitus, the role of attention to symptoms, as well as silence, plays a large role in experience and severity.
Tinnitus, an auditory perception that cannot be attributed to an external source, affects at least 36 million Americans on some level, with at least seven million experiencing it so severely that it interferes with daily activities. The disorder is most often caused by damage to the microscopic endings of the hearing nerve in the inner ear, although it can also be attributed to allergies, high or low blood pressure (blood circulation problems), a tumor, diabetes, thyroid problems, injury to the head or neck, and use of medications such as anti-inflammatories, antibiotics, sedatives, antidepressants, and aspirin.
Public release date: 1-Jan-2008
The very old may benefit from L-carnitine
The dietary supplement L-carnitine can lessen fatigue and boost mental function in very old people, Italian researchers report.
Study participants given L-carnitine also experienced significant increases in muscle mass and reductions in fat mass, Dr. Mariano Malaguarnera and colleagues from the University of Catania report in the December issue of the American Journal of Clinical nutrition.
L-carnitine helps cells to produce energy from fat. The highest concentrations of the molecule are found in parts of the body with high energy demands, such as the skeletal muscles and the heart. Overall concentrations of L-carnitine decline after age 70.
To determine if supplementation with L-carnitine might improve energy levels in people 100 and older, Malaguarnera’s team randomized 66 male and female centenarians to 2 grams of L-carnitine or placebo daily for six months.
Cholesterol levels fell significantly among the individuals taking the supplement, they report. L-carnitine takers also gained 3.8 kilograms (8.4 pounds) of muscle mass, on average, and lost 1.8 kg (4 pounds) of fat mass. People given L-carnitine were also able to walk 4 meters (13 feet) further during a 6-minute walking test after treatment than those given placebo.
Study participants in the L-carnitine group also reported significant reductions in mental, physical and overall fatigue, while placebo treatment had no effect on fatigue. The individuals who took the supplement also scored higher on a test of mental function after treatment, while there was no change in the placebo group.
The supplement was well tolerated by study participants, the researchers report, with no serious side effects.
SOURCE: American Journal of Clinical Nutrition, December 2007.
Public release date: 1-Jan-2008
Environmental Trigger for Alzheimer’s Disease
Early exposure to environmental toxins can lead to diseases much later in life. This week, Wu et al. report that primates exposed to lead as infants showed Alzheimer’s disease (AD)-like pathology years later. From birth to 400 d of age, monkeys were exposed to lead levels that produced no obvious sign of toxicity. Although by young adulthood blood lead levels in exposed monkeys were indistinguishable from those of controls, when examined at approximately 23 years of age, the brains of lead-exposed monkeys exhibited many hallmarks of AD, including Aâ plaques and neurofibrillary tangles, as well as increased expression of Aâ precursor protein (APP) and Sp1, a transcription factor that regulates APP expression. DNA methyl transferase I activity was reduced in lead-exposed monkeys, whereas oxidative damage to DNA was increased. These results indicate that lead exposure early in life can predispose animals to later neurodegenerative disease, possibly through alterations in DNA methylation and oxidation.
Jinfang Wu, Md. Riyaz Basha, Brian Brock, David P. Cox, Fernando Cardozo-Pelaez, Christopher A. McPherson, Jean Harry, Deborah C. Rice, Bryan Maloney, Demao Chen, Debomoy K. Lahiri, and Nasser H. Zawia
Public release date: 1-Jan-2008
Silence may lead to phantom noises misinterpreted as tinnitus
Phantom noises, that mimic ringing in the ears associated with tinnitus, can be experienced by people with normal hearing in quiet situations, according to new research published in the January 2008 edition of Otolaryngology – Head and Neck Surgery.
The Brazilian study, which consisted of 66 people with normal hearing and no tinnitus, found that among subjects placed in a quiet environment where they were asked to focus on their hearing senses, 68 percent experienced phantom ringing noises similar to that of tinnitus. This is compared to only 45.5 percent of participants who heard phantom ringing when asked to focus on visual stimuli and not on their hearing, and 19.7 percent of those asked to focus on a task in a quiet environment.
The authors believe that these findings show that with regards to tinnitus, the role of attention to symptoms, as well as silence, plays a large role in experience and severity.
Tinnitus, an auditory perception that cannot be attributed to an external source, affects at least 36 million Americans on some level, with at least seven million experiencing it so severely that it interferes with daily activities. The disorder is most often caused by damage to the microscopic endings of the hearing nerve in the inner ear, although it can also be attributed to allergies, high or low blood pressure (blood circulation problems), a tumor, diabetes, thyroid problems, injury to the head or neck, and use of medications such as anti-inflammatories, antibiotics, sedatives, antidepressants, and aspirin.
Public release date: 2-Jan-2008
New discovery could reduce the health risk of high-fat foods
Just as additives help gasoline burn cleaner, a research report published in the January 2008 print issue of The FASEB Journal shows that the food industry could take a similar approach toward reducing health risks associated with fatty foods. These “meal additives” would be based on work of Israeli researchers who discovered that consuming polyphenols (natural compounds in red wine, fruits, and vegetables) simultaneously with high-fat foods may reduce health risks associated with these foods.
“We suggest a new hypothesis to explain polyphenols,” said Joseph Kanner, senior author of the report. “For the first time, these compounds were demonstrated to prevent significantly the appearance of toxic food derivative compounds in human plasma.”
For the study, six men and four women were fed three different meals consisting of dark meat turkey cutlets. One meal, the control, consisted of turkey meat and water. The second meal consisted of turkey meat with polyphenols added after cooking (one tablespoon of concentrated wine) followed with a glass of red wine (about 7 ounces). The third meal consisted of turkey meat with polyphenols added before cooking and then followed by a glass of wine.
At various points during the study, researchers took blood and urine samples to measure levels of malondialdehyde (MDA), a natural byproduct of fat digestion known to increase the risk for heart disease and other chronic conditions. The researchers found that MDA levels nearly quintupled after the control meal, while MDA was nearly eliminated after subjects consumed the meals with polyphenols.
Public release date: 2-Jan-2008
The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States
In the late 1950s, the late Democratic Senator Estes Kefauver, Chairman of the United States Senate’s Anti-Trust and Monopoly Subcommittee, put together the first extensive indictment against the business workings of the pharmaceutical industry. He laid three charges at the door of the industry: (1) Patents sustained predatory prices and excessive margins; (2) Costs and prices were extravagantly increased by large expenditures in marketing; and (3) Most of the industry’s new products were no more effective than established drugs on the market [1]. Kefauver’s indictment against a marketing-driven industry created a representation of the pharmaceutical industry far different than the one offered by the industry itself. As Froud and colleagues put it, the image of life-saving “researchers in white coats” was now contested by the one of greedy “reps in cars” [2]. The outcome of the struggle over the image of the industry is crucial because of its potential to influence the regulatory environment in which the industry operates.
Fifty years later, the debate still continues between these two depictions of the industry. The absence of reliable data on the industry’s cost structures allows partisans on both sides of the debate to cite figures favorable to their own positions. The amount of money spent by pharmaceutical companies on promotion compared to the amount spent on research and development is at the heart of the debate, especially in the United States. A reliable estimate of the former is needed to bridge the divide between the industry’s vision of research-driven, innovative, and life-saving pharmaceutical companies and the critics’ portrayal of an industry based on marketing-driven profiteering.
IMS, a firm specializing in pharmaceutical market intelligence, is usually considered to be the authority for assessing pharmaceutical promotion expenditures. The US General Accounting Office, for example, refers to IMS numbers in concluding that “pharmaceutical companies spend more on research and development initiatives than on all drug promotional activities” [3]. Based on the data provided by IMS [4], the Pharmaceutical Research and Manufacturers of America (PhRMA), an American industrial lobby group for research-based pharmaceutical companies, also contends that pharmaceutical firms spend more on research and development (R&D) than on marketing: US$29.6 billion on R&D in 2004 in the US [5] as compared to US$27.7 billion for all promotional activities.[4]
In this paper, we make the case for the need for a new estimate of promotional expenditures. We then explain how we used proprietary databases to construct a revised estimate and finally, we compare our results with those from other data sources to argue in favor of changing the priorities of the industry.
The Case for a New Estimate of Pharmaceutical Promotion
There are many concerns about the accuracy of the IMS data. First, IMS compiles its information through surveys of firms, creating the possibility that companies may systematically underestimate some of their promotional costs to enhance their public image. Second, IMS does not include the cost of meetings and talks sponsored by pharmaceutical companies featuring either doctors or sales representatives as speakers. The number of promotional meetings has increased dramatically in recent years, going from 120,000 in 1998 to 371,000 in 2004 [6]. In 2000, the top ten pharmaceutical companies were spending just under US$1.9 billion on 314,000 such events [7]. Third, IMS does not include the amount spent on phase IV “seeding” trials, trials designed to promote the prescription of new drugs rather than to generate scientific data. In 2004, 13.2% (US$4.9 billion) of R&D expenditures by American pharmaceutical firms was spent on phase IV trials [5]. Almost 75% of these trials are managed solely by the commercial, as opposed to the clinical, division of biopharmaceutical companies, strongly suggesting that the vast majority of these trials are done just for their promotional value [8].
Finally, IMS data seem inconsistent with estimates based on the information in the annual reports of pharmaceutical companies. For example, in an accounting study based on the annual reports of ten of the largest global pharmaceutical firms, Lauzon and Hasbani showed that between 1996 and 2005, these firms globally spent a total of US$739 billion on “marketing and administration.” In comparison, these same firms spent US$699 billion in manufacturing costs, US$288 billion in R&D, and had a net investment in property and equipment of US$43 billion, while receiving US$558 billion in profits [9].
Annual reports, however, have their own limitations. First, pharmaceutical firms are multinational and diversified; their annual reports provide no information on how much they spend on pharmaceutical marketing, as compared to the marketing of their non-pharmaceutical products, and they do not provide information about how much is spent on marketing specifically in the US. Second, annual reports merge the categories of “marketing” and “administration,” without delineating the relative importance of each. Finally, “marketing” is a category that includes more than just promotion; it also includes the costs of packaging and distribution. In terms of offering a more precise estimate of overall expenditures on pharmaceutical promotion in the US, annual reports are thus far from satisfactory.
In the absence of any collection of information on promotional spending by government or any other noncommercial source, the market research company IMS has long been the only source of such information, which it gains by surveying pharmaceutical firms. Since 2003, however, the market research company CAM has been providing comprehensive information on promotion expenditures by surveying doctors instead of firms. (In July 2005, CAM was merged into the Cegedim Group, another market research company.) We chose to compare IMS data to those produced by CAM in order to provide a more accurate estimate of promotional spending in the US. Other proprietary sources of data do not break down promotional expenditures into different categories and therefore were not used in our comparison.
Methods
According to its Web site (http://www.imshealth.com/), IMS provides business intelligence and strategic consulting services for the pharmaceutical and health care industries. It is a global company established in more than 100 countries. IMS gathers data from 29,000 data suppliers at 225,000 supplier sites worldwide. It monitors 75% of prescription drug sales in over 100 countries, and 90% of US prescription drug sales. It tracks more than 1 million products from more than 3,000 active drug manufacturers. IMS data for 2004 were obtained from its Web site for the amount spent on: visits by sales representatives (detailing), samples, direct-to-consumer advertising, and journal advertising.
The Cegedim Web site (http://www.cegedim-crm.com/index.php?id=12) describes CAM as a global company dedicated to auditing promotional activities of the pharmaceutical industry, established in 36 countries worldwide. CAM annually surveys a representative sample of 2,000 primary care physicians and 4,800 specialists in a variety of specialties in selected locations in the US. From CAM’s newsletter [10], we obtained access to data from CAM for the same promotion categories as from IMS. In addition, CAM provided figures for the amount of spending on company-sponsored meetings, e-promotion, mailings, and clinical trials.
We used 2004 as the comparison year because it was the latest year for which information was available from both organizations. We focused on the US because it is the only country for which information is available for all important promotional categories. The US is also, by far, the largest market for pharmaceuticals in the world, representing around 43% of global sales [11,12] and global promotion expenditures [10,13].
We asked both CAM and IMS about the procedures that they used to collect information on different aspects of promotion. Based on the answers we received, we determined the relevant figures for expenditures for samples and detailing. Each author independently decided on which values should be used, based on an understanding of the methods that the companies used to collect the information and the limitations of those methods. Differences were resolved by consensus.
We queried CAM and IMS about the estimated value of unmonitored promotional expenditures. IMS did not provide an answer to this question. In order to validate its estimates, CAM relies on a validation committee that includes representatives from various pharmaceutical firms, including Merck, Pfizer, Bristol-Myers Squibb, Eli Lilly, Aventis, Sanofi-Synthelabo, AstraZeneca, and Wyeth. Under a confidentiality agreement, the firms supply CAM with internal data related to their detailing activity and promotional costs in the US. Through the validation committee, CAM can thus compare totals obtained through its own audits with the firms’ internal data about their promotional budgets in order to evaluate if all promotion has been properly audited through its physician surveys. As a result of this comparison, CAM’s validation committee considers that about 30% of promotional spending is not accounted for in its figures. CAM is unable to provide an exact breakdown of unmonitored promotion, but it believes that around 10% is due to incomplete disclosure and omissions by surveyed physicians and the remaining 20% comes from a combination of promotion directed at categories of physicians that are not surveyed, unmonitored journals in which pharmaceutical promotion appears, and possibly unethical forms of promotion. We adjusted total expenditures to account for this unreported 30%.
Results
For 2004, CAM reported total promotional spending in the US of US$33.5 billion [10], while IMS gave the figure of US$27.7 billion for the same year [4]. Both CAM and IMS cited the media intelligence company CMR as the source for the amount spent on direct-to-consumer advertising (US$4 billion), and they also gave the same figure for journal advertising (US$0.5 billion).
There were two major differences between the two sets of figures: the amounts spent on detailing and the amounts spent on samples. IMS estimated the amount spent on detailing at US$7.3 billion [4] versus US$20.4 billion for CAM [10], and while IMS gave a retail value of US$15.9 billion for samples [14], CAM estimated a wholesale value of US$6.3 billion [10].
Using the IMS figure of US$15.9 billion for the retail value of samples, and adding the CAM figures for detailing and other marketing expenses after correcting for the 30% estimate of unaccounted promotion, we arrived at US$57.5 billion for the total amount spent in the US in 2004, more than twice what IMS reported (see Table 1).
Table 1. Pharmaceutical Marketing Expenditures in the United States in 2004: Data from IMS, CAM, and Our New Estimate
Discussion
Our revised estimate for promotional spending in the US is more than twice that from IMS. This number compares to US$31.5 billion for domestic industrial pharmaceutical R&D (including public funds for industrial R&D) in 2004 as reported by the National Science Foundation [15].
However, even our revised figure is likely to be incomplete. There are other avenues for promotion that would not be captured by either IMS or CAM, such as ghostwriting [16] and illegal off-label promotion [17]. Furthermore, items with promotional potential such as “seeding trials” or educational grants might be included in other budgets and would not be seen in the confidential material provided to CAM’s validation committee.
IMS and CAM data were used for comparison purposes for a number of reasons: data from both were publicly available, both operate on a global scale and are well regarded by the pharmaceutical industry, both break down their information by different categories of promotion, and, most importantly, they use different methods for gathering their data, thereby allowing us to triangulate on a more accurate figure for each category.
Methodological differences between the ways that IMS and CAM collect data will affect the values for promotional spending depending on the category being considered. Because of the problematic nature of some data from each firm, we believe that the most precise picture of industry spending can be obtained by selectively using both sets of figures.
CAM compiles its data on the value of detailing and samples through systematic surveys of primary care providers and specialists and by estimating an average cost for each visit by a sales representative according to the type of physician. By contrast, IMS compiles its data on the value of detailing through surveys of firms, while its data on samples are obtained by monitoring products directly from manufacturers.
There is a significant discrepancy between the two sets of data in the cost of detailing: US$7.3 billion for IMS and US$20.4 billion for CAM. This difference can be explained by the fact that CAM offers a more complete data set since it includes in the average cost of a call (a sales representative’s visit to a physician) not only the “cost to field the rep” (salary and benefits of the representative and the transportation cost) but also the costs for the area and regional managers, the cost of the training, and the cost of detail aids such as brochures and advertising material. By contrast, in reporting the cost of detailing IMS only considers the “cost to field the rep.” Furthermore, relying on physician-generated data to estimate the amount spent on detailing is likely to give a more accurate figure than using figures generated by surveying firms. Companies may not report some types of detailing, for example, the use of sales representatives for illegal off-label promotion, whereas doctors are not likely to distinguish between on- and off-label promotion and would report all encounters with sales representatives.
In the case of samples, there is also a large difference between the IMS (US$15.9 billion) and CAM (US$6.3 billion) estimates. CAM estimates the amount spent on samples by multiplying the number of samples declared by physicians with their wholesale value. The latter is determined by using the average wholesale price (AWP), which is the amount set by manufacturers and used by Medicare in the US to determine reimbursement. CAM then divides that amount in half to account for the fact that samples are frequently given out in small dosage forms. CAM admits, however, that the amount for samples is understated because, when physicians fill out their survey, any quantity of samples of the same product left during a call is considered to be only one sample unit. CAM’s calculations also rely on the AWP, which has been criticized for not taking into account the various discounts and rebates that are negotiated between manufacturers and purchasers [18].
IMS provides exact figures for the retail value for samples by monitoring 90% of all pharmaceutical transactions and by tracking products directly from manufacturers. This method for calculating the value of samples is much more direct than CAM’s and therefore is likely to be subject to less error.
Using the wholesale value for samples, the CAM figure would be appropriate if we were arguing that the money spent on samples should go to another activity such as R&D. However, we have used the retail value of samples because this is consistent with companies’ reporting of drugs they donate [19]. As these are both categories of products that are being distributed without a charge to the user, it is inconsistent for donations to be reported in terms of retail value and samples in terms of wholesale value.
We believe that it is appropriate to correct for unmonitored promotion and that the figure we used is a reliable estimate. The 30% correction factor is based on a direct comparison that CAM is able to make between the data it collects through its surveys and the amount reported by companies.
There are other ways of combining the data that we have presented, but with the exception of choosing the lower amounts for detailing and samples and ignoring the 30% for unmonitored promotion, all of them yield a higher figure than the one from IMS. Some examples of alternative estimates follow: using the CAM estimate for the wholesale value of samples and the 30% adjustment, the total amount would be US$47.9 billion; without the 30% adjustment CAM’s estimate is US$33.5 billion. Adding the figures for the categories that IMS does not cover (meetings, e-promotion, mailing, clinical trials) boosts its estimate to US$31 billion; using the lower figures for detailing and samples plus the CAM amounts for the other categories and applying the 30% adjustment gives an amount of US$29.1 billion. Therefore, the actual amount could range from a low of US$27.7 billion to a high of US$57.5 billion. Our analysis shows, however, that the figure of US$57.5 billion is the most appropriate one when using the most relevant figures for each category of promotional spending.
Excluding direct-to-consumer advertising, CAM considers that around 80% of the remaining promotion is directed towards physicians, with 20% of this figure going to pharmacists. (IMS does not provide any comparable values.) With about 700,000 practicing physicians in the US in 2004 [20], we estimate that with a total expenditure of US$57.5 billion, the industry spent around US$61,000 in promotion per physician. As a percentage of US domestic sales of US$235.4 billion [21], promotion consumes 24.4% of the sales dollar versus 13.4% for R&D.
Our new estimate of total promotion costs and promotion as a percentage of sales is broadly in line with estimates of promotional or marketing spending from other sources. The annual reports of Novartis distinguish “marketing” from “administration.” Marcia Angell extrapolates from this annual report to the entire industry and calculates a figure of US$54 billion spent on pharmaceutical promotion in the US in 2001 [22]. As a proportion of sales, she estimates 33% is spent on marketing. Using similar methodology, the Office of Technology Assessment derived an estimate for marketing costs in the US by extrapolating from the cost structure of Eli Lilly. The Office of Technology Assessment considers that firms spend around 22.5% of their sales on marketing [23]. Based on United Nations Industrial Development Organization estimates, a report from the Organization for Economic Cooperation and Development estimated that, in 1989, pharmaceutical firms globally spent 24% of their sales on marketing [24], but few details of the methodology used were provided, making it impossible to verify the accuracy of the estimate. Finally, in 2006 Consumers International surveyed 20 European pharmaceutical firms to obtain more information about their exact expenditures on drug promotion. Among the 20 firms contacted, only five agreed to provide separate figures for marketing, which ranged from 31% to 50% of sales depending on the firm [25].
The results are also consistent with data on the share of revenue allocated to “marketing and administration” according to annual reports of large pharmaceutical companies, if we consider that the largest part of “marketing and administration” is devoted to promotion. Lauzon and Hasbani found that 33.1% of revenues was allocated to “marketing and administration” [9], similar to the 31% reported by the Centers for Medicare and Medicaid Services [26] and the 27% from Families USA [27].
The value of our estimate over these others is that it is not based on extrapolating from annual reports of firms that are both diversified and multinational. Our estimate is driven by quantifiable data from highly reliable sources and concerns only the promotion of pharmaceutical products in the US. The derivation of our figure is thus transparent and can form the basis for a vigorous debate.
Conclusion
From this new estimate, it appears that pharmaceutical companies spend almost twice as much on promotion as they do on R&D. These numbers clearly show how promotion predominates over R&D in the pharmaceutical industry, contrary to the industry’s claim. While the amount spent on promotion is not in itself a confirmation of Kefauver’s depiction of the pharmaceutical industry, it confirms the public image of a marketing-driven industry and provides an important argument to petition in favor of transforming the workings of the industry in the direction of more research and less promotion.
Ralph’s Note – Their spending on R&D included what was donated through taxpayers, and charitable organizations.
Public release date: 2-Jan-2008
Tips to prevent adverse drug events in older adults
BOSTON (January 2, 2008) Adverse drug events are more common in older adults because they are prescribed more drugs and are effected differently by these drugs than their younger counterparts. A review article written by Tufts University School of Medicine clinicians, published in American Family Physician, summarizes steps that physicians and other healthcare providers can take to avoid overuse, misuse, and underuse of medication in older adults.
“About one in three older persons taking at least five medications will experience an adverse drug event each year, and about two-thirds of these patients will require medical attention. Approximately 95 percent of these reactions are predictable, and about 28 percent are preventable,” cite the authors, Cung Pham, MD, fellow in the Tufts University Family Medicine Residency at Cambridge Health Alliance’s Malden Family Medicine Center, and Robert Dickman, MD, Jaharis Family Chair of Family Medicine at Tufts University School of Medicine.
Public release date: 2-Jan-2008
Vitamin D2 is as effective as vitamin D3 in maintaining concentrations of 25-hydroxyvitamin D
Boston, MA— Researchers from Boston University School of Medicine (BUSM) have found that vitamin D2 is equally as effective as vitamin D3 in maintaining 25-hydroxyvitamin D status. The study appears online in the December 2007 issue of the Journal of Clinical Endocrinology & Metabolism.
Researchers studied healthy adults aged 18-84 who received either placebo, 1,000 International Units (IU) of vitamin D3, 1,000 IU of vitamin D2, or 500 IU of vitamin D2 plus 500 IU of vitamin D3 daily for three months at the end of winter to establish what effect it had on circulating levels of total 25 (OH)D as well as 25(OH)D2 and 25(OH)D3. Sixty percent of the adults were vitamin D deficient at the start of the study.
Adults who received the placebo capsule daily for three months demonstrated no significant change in their total 25(OH)D levels during the winter and early spring. Adults who ingested 1,000 vitamin D2/d gradually increased their total 25(OH)D levels during the first six weeks. Adults who ingested 1,000 IU of vitamin D3 had a baseline 25(OH)D that was statistically no different from the baselines of either the placebo group or the groups that took 1,000 IU of vitamin D2/d or 500 IU vitamin D2 plus 500 IU vitamin D3/d. The vitamin D3 group increased their serum 25(OH)D levels similar to that of the group that ingested vitamin D2.
The circulating levels of 25-hydroxyvitamin D increased to the same extent in the groups that received 1,000 IU daily as vitamin D2, vitamin D3, or a combination of 500 IU vitamin D2 and 500 IU vitamin D3. The 25-hydroxyvitamin D3 levels did not change in the group that received 1,000 IU vitamin D2 daily. One thousand IU of vitamin D2 or vitamin D3 did not raise 25-hydroxyvitamin D levels in vitamin D deficient subjects above 30 ng/ml.
Public release date: 2-Jan-2008
Jefferson scientists studying the effects of high-dose vitamin C on non-Hodgkin lymphoma patients
PHILADELPHIA) – Scientists at Thomas Jefferson University Hospital and Jefferson’s Kimmel Cancer Center have received approval for a first-of-its kind study on the effect high dose vitamin C has on non-Hodgkin lymphoma patients. Researchers from the Jefferson-Myrna Brind Center of Integrative Medicine and Kimmel Cancer Center in conjunction with the National Institutes of Health will study whether high doses of vitamin C can slow the progression of the deadly disease.
“This is a very unique study for a set of patients who have really run out of options,” said Daniel Monti, M.D., director of the Myrna Brind Center of Integrative Medicine, and primary investigator of the study. “Vitamin C administered intravenously has shown great promise in the laboratory and there has been some anecdotal data in cancer patients, but no one has really ever run a detailed study on humans. Vitamin C doesn’t cost much and is very low in toxicity, making it a particularly desirable agent for further study.”
Recent research conducted by the NIH collaborators of this study has shown that when given in sufficient amounts intravenously, vitamin C converts to hydrogen peroxide. When applied to certain non-Hodgkin lymphoma cells in the laboratory, the converted hydrogen peroxide kills them while leaving the surrounding healthy cells intact.
“Previous human studies have been flawed because the vitamin C was given orally versus intravenously,” said Monti. “The problem with that is the oral route tightly limits the amount of vitamin C that can get into the bloodstream. When vitamin C is given intravenously you can get up to 70 times more of the vitamin into the blood versus the same dose given orally. It is these high blood levels that are required to get the mechanism of action, vitamin C converting to hydrogen peroxide around the cancer cells, to occur. Although other cancers could be a contender for this intervention, the preliminary data on non-Hodgkin lymphoma cells is why we decided to start with this disease.”
Ralph’s Note- To all those misguided researchers who could not figure out why Vitamin C was in the vicinity of cancer cells. Then tried to imply Vitamin C could be carcinogenic. DUE YOUR HOMEWORK.
Public release date: 2-Jan-2008
Winemaking waste proves effective against disease-causing bacteria in early studies
A class of chemicals in red wine grapes may significantly reduce the ability of bacteria to cause cavities, according to a study published recently in the Journal of Agricultural and Food Chemistry. The findings suggest that specific polyphenols, present in large amounts in fermented seeds and skins cast away after grapes are pressed, interfere with the ability of bacteria to contribute to tooth decay. Beyond cavities, the action of the wine grape-based chemicals may also hold clues for new ways to lessen the ability of bacteria to cause life-threatening, systemic infections.
Researchers prepared polyphenolic extracts from harvest season 2005 red wine grape varieties and pomace from wineries in the Finger Lakes region of New York state. These included Pinot Noir from Hosmer Winery in Ovid, N.Y., Cabernet Franc from Cornell Orchards in Lansing, N.Y., Baco Noir from Pleasant Valley Winery in Hammondsport, N.Y. and NoiretTM from Swedish Hill Winery in Romulus, N.Y. Varieties were pre-screened for their phenolic content, and grape pomace was chosen in general for its ready supply as an inexpensive source material. Red grapes have been shown to contain 40 percent more phenols content than white.
The team was most interested in examining the impact of grape polyphenols on two capabilities of S. mutans that enable it to thrive in the human mouth. First, it secretes enzymes known as glucosyltransferases (GTFs) that produce sugary, glue-like substances (glucans) that firmly attach bacteria to tooth surfaces and form a tough barrier around bacterial colonies. Such barriers, called the extracellular polysaccharide (EPS) matrix, protect the colony against environmental assaults, and make them, in some cases, hundreds of times more resistant to antibiotics. Bacteria living in these gunky fortresses are known as biofilms, whether they occur on teeth or elsewhere in the body. Many Streptococci (strep) and Staphylococci (staph) cause resistant forms of meningitis, pneumonia, staph aureus, as well as infections on heart valves and around stents, by forming biofilms. GTFs are a main virulence factor responsible for S. mutans biofilm formation, but other pathogens use similar mechanisms to produce EPS matrix. The hope is that learning about one will suggest ways to interfere with many.
A second linked set of virulence factors for S. mutans are its abilities to secrete acid, and to survive in that acid. Having evolved to be “acid durable,” S. mutans can survive and out-compete other bacteria in the mouth. Better understanding of these mechanisms could also yield new ways to fight other biofilm related infections.
In the current study, researchers found that all polyphenol extracts inhibited two bacterial GTFs by as much as 85 percent (P<0.01)), a level of inhibition not previously observed in Koo’s lab. Cabernet Franc extracts were more effective GTF inhibitors, with Pinot noir a close second at concentrations that might be useful therapeutically. Grape polyphenols were also found to cause S. mutans to produce significantly less acid. This may be because they inhibit glycolysis, the process by which the bacteria turns sugar into energy also produces acid, researchers said. None of the extracts from any variety killed the bacteria outright. By targeting the ability of S. mutans to form EPS matrix, for example, therapeutic approaches to reducing the formation of biofilms could be precise and selective. Further chemical analysis will be needed to pinpoint which the most effective polythenol mix.
“Overall, the phenolic extracts disrupt essential virulence traits for a widespread, destructive oral pathogen, but without killing it,” said Olga I. Padilla-Zakour, Ph.D., associate professor of Food Processing within the New York Agricultural Experiment Station of Cornell University. “We are excited about the potential application of active compounds from wine grape by-products in the control of biofilms as part of the precise targeting of bacterial disease.”
Public release date: 2-Jan-2008
The prevalence and impact of arthritis and other rheumatic conditions in the United States
The National Arthritis Data Workgroup was formed to provide a single source of national data on various rheumatic conditions. Supported by the National Institutes of Health, the Centers for Disease Control, the American College of Rheumatology, and the Arthritis Foundation, its epidemiology experts use the best studies available to determine disease prevalence, assess potential disease impact, and identify gaps in our understanding of disease rates, populations, and social implications. In the January 2008 issue of Arthritis & Rheumatism
Based on analyses of population estimates from the Census Bureau, responses from national surveys, and findings from scores of community-based studies across the country, the National Arthritis Data Workgroup offers an unsettling snapshot of the 2005 (and future) burden of arthritis. Some key findings of the study include:
Overall arthritis: More than 21 percent of U.S. adults—over 46 million people– have arthritis or other rheumatic condition diagnosed by a doctor. Nearly two-thirds of arthritis patients are younger than 65. More than 60 percent are women. Disease rates are similar for whites and African-Americans and higher than the rates for Hispanics. By 2030, the number of people with arthritis is projected to increase to nearly 67 million—an increase of 40 percent.
Osteoarthritis (OA): Nearly 27 million Americans suffer from OA, the most common type of arthritis, an increase from the 21 million estimated in 1990. Rising with age, OA prevalence also affects the hands and knees of women more frequently than men and of African Americans more frequently than whites.
Rheumatoid Arthritis (RA): This confounding and destructive inflammatory disease affects 1.3 million adults, down from the 1990 estimate of 2.1 million–in part due to more restrictive classification criteria but also because of a real drop in prevalence . Trends show that the average age of diagnosis has increased steadily over time, suggesting that RA is becoming a disease of older adults.
Gout: In 2005 roughly 3 million Americans had gout in the previous 12 months, up from the estimate of 2.1 million in 1990. An inflammatory arthritis linked to elevated uric acid in the blood, gout tends to be most prevalent among older men and more prevalent in older African American males than in older white or Hispanic males.
Juvenile Arthritis: Based on recent data from pediatric ambulatory care visits, an estimated 294,000 children between the ages of infancy and 17 are affected by arthritis or other rheumatic conditions.
The report also includes 2005 prevalence estimates for fibromyalgia, spondylarthritides, systemic lupus erythematosus, systemic sclerosis, Sjögren’s syndrome, carpal tunnel syndrome, polymyalgia rheumatic/giant cell arteritis, and back and neck pain.
“Measuring the prevalence of arthritis poses many challenges,” acknowledges National Arthritis Data Workgroup spokesperson and member, Dr. Charles G. Helmick. For starters, some conditions are episodic and others have no standard case definition. In addition, estimates for some rheumatic conditions rely on small or older studies with results that might not apply to the current U.S. population. However, this report calls attention to the high prevalence of arthritis nationwide and the growing burden on not only our health care and public health systems, but also on American industry and society.
Public release date: 2-Jan-2008
Older surgical patients at greater risk for developing cognitive problems
DURHAM, N.C. — Patients over the age of 60 who have elective surgeries such as joint replacements, hysterectomies and other non-emergency, inpatient procedures, are at an increased risk for long-term cognitive problems, according to a new study led by Duke University Medical Center researchers
“We have known that patients undergoing heart surgery are at risk for cognitive dysfunction — problems with memory, concentration, processing of information — but the effects of non-cardiac surgeries on brain function are not as well-understood,” said Terri Monk, M.D., an anesthesiologist at Duke and the Durham Veterans Affairs Medical Center, and lead investigator on the study. “Our study found that increasing age put patients in this population at greater risk for cognitive problems and this is significant because the elderly are the fastest growing segment of the population. We know that half of all people 65 and older will have at least one surgery in their lifetime.”
The study found that many of the young, middle-aged and elderly patients experienced postoperative cognitive dysfunction (POCD) at the time they left the hospital. But three months later, those aged 60 and older were more than twice as likely to exhibit POCD. Those with POCD at both the time of hospital discharge and three months after surgery also were more likely to die within the first year after surgery, Monk said.
Public Release: 4-Jan-2008
100% of people carry at least one type of pesticide from the air, water or food in their bodies
UGR News. A study carried out by researchers from the Department of Radiology and Physical Medicine of the University of Granada, in collaboration with the Escuela Andaluza de Salud Pública, found that 100% of Spaniards analyzed had at least one kind of persistent organic compound (POC´s), substances internationally classified as potentially harmful to one’s health, in their bodies. These substances enter the body trough food, water or even air. All of them tend to accumulate in human adipose tissue and easily enter into the organism through the aforementioned mediums.
The study, conceived by Juan Pedro Arrebola Moreno and directed by professors Piedad Martín Olmedo, Nicolás Olea Serrano and Mariana F. Fernández Cabrera, measured the contamination levels of some persistent organic compounds (POC’s) in a sample of the adult population from two areas, an urban one (Granada capital city) and a semi-rural one (Motril), and intended to find the determining factors associated with such levels: diet, lifestyle, activities or residence.
A total of 387 adults, from both sexes, were volunteers for surgeries in hospitals taking part in the study (Santa Ana de Motril and San Cecilio de Granada hospital). Once the volunteers had given consent, a sample of their human adipose tissue (fat) was taken during surgery and they answered a questionnaire about their place of residence, lifestyle, eating habits and activities throughout their life.
Analysis of 6 POC´s
The researchers analyzed the samples and measured 6 different POC concentration levels: DDE, a principal metabolite in DDT (a pesticide used in Spain until the 80´s); hexachlorobenzene, a compound used as fungicide and currently released by industrial processes; PCB’s: compounds related to industrial processes; and Hexaclorociclohexano, used as an insecticide and currently used in scabies and pediculosis treatment.
The study carried out by the University of Granada concluded that 100% of subjects analyzed had DDE in their bodies, a substance banned in Spain, and other very frequent components such as PCB-153 (present in 92% of people), HCB (91%), PCB-180 (90%), PCB-138 (86%9) and HCH (84%).
Juan Pedro Arrebola Moreno explains that higher levels of toxic substances were detected in women compared to men and in older volunteers compared to younger people, “possibly due to the great persistence of these substances in the environment, which results in their biomagnification in the food chain and in their bioaccumulation over time”. The scientist added that there is another theory known as “Efecto Cohorte” (Cohort effect) that explains the high quantities of these substances in older people. According to this theory, those born in periods of higher contamination suffered the consequences more than those born with the current bans on such pesticides.
The impact of diet
This study indicates that diet is an important factor in POC concentration, as the ingestion of some aliments, particularly those of animal origin and high fat content, triggers a greater presence of these toxic substances in the human organism.
Juan Pedro Arrebola Moreno states, “There are few studies in Spain measuring POC levels in wide samples of the population, which means that some compound levels in the general population are unknown”. Consequently, this study will improve the knowledge of such levels, and will identify those groups at higher risk of exposure, which is the first step for subsequent follow-up studies determining the cause-effect relations.
This study is part of a project subsidized by the FIS (Sanitarian Investigation Fund) and by the Andalusian Regional Government, and in which the University of Granada, the Escuela Andaluza de Salud Pública, and the Santa Ana and San Cecilio Hospitals take part.
Public release date: 4-Jan-2008
Strength training of neck muscles relieves chronic pain
Neck pain has been steadily increasing over the past two decades and is now second to back pain, the most common musculoskeletal disorder. Women are more likely than men to suffer from persistent neck pain, in particular those who engage in repetitive tasks such as working at a computer keyboard. Previous studies have shown conflicting results as to whether or not exercise can effectively treat neck pain, but there has not been enough high-quality research in this area to draw firm conclusions. A new study on women with neck pain published in the January issue of Arthritis Care & Research (http://www.interscience.wiley.com/journal/arthritiscare) found that specific strength training exercises led to significant prolonged relief of neck muscle pain, while general fitness training resulted in only a small amount of pain reduction.
Led by Gisela Sjøgaard and Lars L. Andersen of the National Research Centre for the Working Environment in Copenhagen, Denmark, researchers conducted a randomized controlled trial for which they recruited 94 women from seven workplaces in Copenhagen between September 2005 and March 2006. The work tasks performed by the women consisted of assembly line work and office work, with 79 percent of the participants using a keyboard for more than three-quarters of their working time. Participants first answered a questionnaire about their pain and then underwent a clinical exam to confirm a diagnosis of trapezius myalgia (muscle pain in the trapezius muscle, which extends along the back of the neck). Participants were assigned to three intervention groups: those who did supervised specific strength training (SST) exercises for the neck and shoulder muscles, those who did high-intensity general fitness training (GFT) on a bicycle ergometer, and a control group that received health counseling but no physical training. Both exercise groups worked out for 20 minutes three times a week for 10 weeks.
The results showed that the GFT group showed a small decrease in neck muscle pain only immediately after exercise, while the SST group showed a marked decrease in pain over a prolonged training period and with a lasting effect after the training ended. “Thus specific strength training locally of the neck and shoulder muscles is the most beneficial treatment in women with chronic neck muscle pain,” the authors state.
The study also showed that the reduction in pain occurred gradually in the SST group, with trapezius muscle pain gradually decreasing as muscle strength increased. Although the GFT decreased the pain only temporarily, the authors note that even minor decreases in pain may be enough motivation to overcome barriers to exercise, and the resulting increase in fitness may benefit overall long-term health.
The authors state that the marked reduction in pain in the SST group is of “major clinical importance.” They conclude: “Based on the present results, supervised high-intensity dynamic strength training of the painful muscle 3 times a week for 20 minutes should be recommended in the treatment of trapezius myalgia.”
Public release date: 3-Jan-2008
Treatment with NAC is associated with better outcomes for children with liver failure
A new retrospective study on the effects of N-acetylcysteine (NAC) on children with acute liver failure not caused by acetaminophen poisoning has found that the treatment was associated with a shorter hospital stay, higher incidence of liver recovery, and better survival after transplantation. The study is in the January issue of Liver Transplantation, a journal by John Wiley & Sons. The article is also available online via Wiley Interscience (http://www.interscience.wiley.com/journal/livertransplantation).
Acute liver failure in children is rare but can be fatal. Acetaminophen poisoning is a common cause, and is treated with NAC, which acts as an antidote, an anti-inflammatory agent and an antioxidant. One small, uncontrolled study suggested that NAC could also help children with non-acetaminophen induced acute liver failure, leading some medical centers to adopt the treatment. Recently, researchers led by Christine Kortsalioudaki of King’s College Hospital in London sought to retrospectively evaluate whether NAC is beneficial for those children.
They examined the medical records of 170 children who came to King’s College Hospital with non-acetaminophen induced acute liver failure between 1989 and 2004. Those treated before 1994 were not treated with NAC, while those who came after 1995 did receive NAC. All the children also received standard care to maintain normal tissue oxygenation and prevent and address complications of acute liver failure.
The children who received NAC spent fewer days in intensive care, and in the hospital overall. 43 percent survived with their native liver, compared to 22 percent of children who did not receive NAC. And death rates while awaiting transplant, after transplant, and after ten years were notably lower in children who had received NAC. Adverse effects were mentioned in just 11 percent of cases and NAC was discontinued in one.
“Our data demonstrates that NAC has minor, self-limited adverse effects and can be safely administered to children with non-acetaminophen induced acute liver failure,” the authors report. “Additionally this study suggests NAC may have a positive effect on the outcome of non-acetaminophen induced acute liver failure, improving the survival with native liver as well as post liver transplant survival.”
Public Release: 6-Jan-2008
Pollution shrinks foetus size: Brisbane study finds
Exposure to air pollution significantly reduces foetus size during pregnancy, according to a new study by Brisbane scientists.
Queensland University of Technology senior research fellow Dr Adrian Barnett said the study compared the foetus sizes of more than 15,000 ultrasound scans in Brisbane to air pollution levels within a 14km radius of the city.
“The study found that mothers with a higher exposure to air pollution had foetuses that were, on average, smaller in terms of abdominal circumference, head circumference and femur length,” Dr Barnett said.
The 10-year study, which was undertaken by Dr Barnett, Dr Craig Hansen (US Environmental Protection Agency) and Dr Gary Pritchard (PacUser), has been published in the international journal Environmental Health Perspectives.
“If the pollution levels were high the size of the foetus decreased significantly.”
Public release date: 7-Jan-2008
Lack of vitamin D may increase heart disease risk
The same vitamin D deficiency that can result in weak bones now has been associated with an increased risk of cardiovascular disease, Framingham Heart Study researchers report in Circulation: Journal of the American Heart Association
“Vitamin D deficiency is associated with increased cardiovascular risk, above and beyond established cardiovascular risk factors,” said Thomas J. Wang, M.D., assistant professor of medicine at Harvard Medical School in Boston, Mass. “The higher risk associated with vitamin D deficiency was particularly evident among individuals with high blood pressure.”
In a study of 1,739 offspring from Framingham Heart Study participants (average age 59, all Caucasian), researchers found that those with blood levels of vitamin D below15 nanograms per milliliter (ng/mL) had twice the risk of a cardiovascular event such as a heart attack, heart failure or stroke in the next five years compared to those with higher levels of vitamin D.
Overall, 28 percent of individuals had levels of vitamin D below15 ng/mL and 9 percent had levels below10 ng/mL. Although levels above 30 ng/mL are considered optimal for bone metabolism, only 10 percent of the study sample had levels in this range, researchers said.
During follow-up:
- · 120 participants developed a first cardiovascular event including fatal and nonfatal coronary heart disease;
- · 28 participants had fatal or nonfatal cerebrovascular events such as nonhemorrhagic stroke;
- · 19 participants were diagnosed with heart failure; and
- · 8 had occurrences of claudication, fatigue in the legs during activity.
“Low levels of vitamin D are highly prevalent in the United States, especially in areas without much sunshine,” Wang said. “Twenty to 30 percent of the population in many areas has moderate to severe vitamin D deficiency.”
Public release date: 7-Jan-2008
Infants with Birthmarks Received Less Oxygen in Womb
Madrid, Spain – January 7, 2008 – A hemangioma is a benign tumor of cells that line blood vessels, appearing during the first few weeks of life as a large birthmark or lesion. A study published in Pediatric Dermatology reveals that a disturbance of oxygen depletion was found in placentas of babies who developed infantile hemangioma (IH).
Researchers reviewed placental samples from 26 pregnancies with babies who weighed less than 3.5 pounds, 13 consisting of newborns who developed IH after birth and 13 healthy preterm infants who did not have IH.
Only one of the infants without IH showed an abnormal placenta. The higher ratio of placental anomalies in babies with IH suggests that reduced oxygen to the placenta contributed to fetal stress, and that stress led to infantile hemangioma development.
“Our results suggest that disturbed placental circulation is a factor underlying the development of hemangiomas in very low weight newborns and indicates that placental examination is essential for clarifying the physiologic changes leading to IH in babies with normal birth weight,” the authors conclude.
Public release date: 7-Jan-2008
Trichloroethylene is a risk factor for parkinsonism
Parkinson’s disease, the most common neurodegenerative movement disorder caused by aging, can also be caused by pesticides and other neurotoxins. A new study found strong evidence that trichloroethylene (TCE) is a risk factor for parkinsonism, a group of nervous disorders with symptoms similar to Parkinson’s disease. TCE is a chemical widely used in industry that is also found in drinking water, surface water and soil due to runoff from manufacturing sites where it is used. The study was published in the October 2007 issue of Annals of Neurology (http://www.interscience.wiley.com/journal/ana), the official journal of the American Neurological Association.
Led by Don M. Gash and John T Slevin, of the University of Kentucky in Lexington, KY, researchers conducting a clinical trial of 10 Parkinson’s disease patients came across a patient who described long-term exposure to TCE, which he suspected to be a risk factor in his disease. TCE has been identified as an environmental contaminant in almost 60 percent of the Superfund priority sites listed by the Environmental Protection Agency and there has been increasing concern about its long term effects. The patient noted that some of his co-workers had also developed Parkinson’s disease, which led to the current study of this patient and two of his co-workers diagnosed with Parkinson’s disease who underwent neurological evaluations to assess motor function. All of these individuals had at least a 25 year history of occupational exposure to TCE, which included both inhalation and exposure to it from submerging their unprotected arms and forearms in a TCE vat or touching parts that had been cleaned in it. In addition, questionnaires about experiencing signs of Parkinson’s disease, such as slowness of voluntary movement, stooped posture and trouble with balance, were mailed to 134 former workers. The researchers also conducted studies in rats to determine how TCE affects the brain.
The results showed that 14 former employees who reported three or more parkinsonian signs worked close to the TCE source, were found to exhibit signs of parkinsonism when they were examined and were significantly (up to 250 percent) slower in fine motor hand movements than age-matched controls. Clinical exams of 13 patients who reported no signs of parkinsonism revealed that they worked in the same areas as the symptomatic workers or further from the TCE vat, they exhibited some mild features of the condition and their fine motor movements were also significantly slower than controls, although they were faster than the group with symptoms. The rat studies showed that TCE exposure inhibited mitochondrial function (which in humans is associated with a wide range of degenerative diseases) in the substantia nigra, an area in the brain that produces dopamine and whose destruction is associated with Parkinson’s disease. Specifically, Complex 1, an enzyme important in energy production, was significantly reduced in the substantia nigra. Dopamine neurons in this area also showed degenerative changes following TCE administration.
Public release date: 8-Jan-2008
US ranks last among other industrialized nations on preventable deaths
January 8, 2008, Bethesda, MD—The United States places last among 19 countries when it comes to deaths that could have been prevented by access to timely and effective health care, according to new research supported by The Commonwealth Fund and published in the January/February issue of Health Affairs. While other nations dramatically improved these rates between 1997–98 and 2002–03, the U.S. improved only slightly
If the U.S. had performed as well as the top three countries out of the19 industrialized countries in the study there would have been 101,000 fewer deaths in the U.S. per year by the end of the study period. The top performers were France, Japan, and Australia.
In 1997–98 the U.S. ranked 15th out of 19 countries on the “mortality amenable to health care” measure. However, by 2002–03 the U.S. fell to last place, with 109 deaths amenable to health care for every 100,000 people. In contrast, mortality rates per 100,000 people in the leading countries were: France (64), Japan (71), and Australia (71). The other countries included in the study were Austria, Canada, Denmark, Finland, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden and the United Kingdom.
Public release date: 8-Jan-2008
American women are more likely to choose overly aggressive treatments for breast cancer
Despite a 1990 consensus recommendation from the National Institutes of Health (NIH) that lumpectomy plus radiation was the treatment of choice for early stage breast cancer, the United States continues to have the highest rate of mastectomy surgery among industrialized countries. Why would a person knowingly undertake a far more severe form of treatment when a lesser one would suffice? A recent survey shows that only 74 percent of women diagnosed with early stage breast cancer (ductal carcinoma in situ or DCIS) chose breast-conserving surgery – even though 82 percent of their physicians had recommended the procedure.
“To answer this question, we investigate the framing of individual risk understandings by the broader cultural discourses surrounding the disease,” explain Nancy Wong and Tracey King (both Georgia Institute of Technology). “In-depth interviews . . . suggest that screening and treatment decisions are influenced by the predilection toward restitution narratives that exists in the United States and other Anglo-western societies. Reflecting culturally structured values toward illness, the dominant narrative of restitution is reinforced by the long-established biomedical model through its emphasis on personal agency, control, and survival.”
Due to increases in the availability and sophistication of mammographic screening, DCIS now accounts for approximately 20 percent of all breast cancer cases. The researchers find that women’s individual understandings of breast cancer and the risks associated with detection, treatment, and reconstructive surgery are heavily influenced by the ideas of vigilant detection, aggressive treatment, and conformity in maintaining appearances.
“The burden of personal responsibility is so ingrained that women often feel that they are to blame for not detecting the disease earlier or for having failed to pursue the most aggressive treatment,” the researchers explain. “Furthermore, despite widespread information dissemination and requirements for physicians to discuss breast cancer treatments, women still do not translate this information into accurate risk assessments regarding their treatment options. Instead, they rely on stories of survivorship and restitution in constructing their risk understandings.”
They continue: “The impact of individual beliefs in restitution through aggressive detection and treatment is reflected in a broader sense by statistics on overall healthcare consumption in this country. From breast cancer and heart surgery to diabetes, numerous reports from general interest, business, and public health publications have raised concerns about the over-consumption of and runaway spending on medical treatments.”
The researchers suggest that increased efforts in education and intervention alone will not be enough to offset these implicit cultural biases. In order to understand why patients often choose difficult and expensive treatments that may not necessarily yield improvements in their quality of life or odds of survival, they reveal that we must also consider the deeply entrenched illness narratives that frame patient’s interpretations of medical and risk information.
“Illness narratives allow us to convey, express, and formulate our experiences of illness and suffering, thus providing a platform for shared cultural experiences,” Wong and King write. “We hope that this research will direct more attention to the recognition and conceptualization of these alternative discourses within an expanded composition of illness narratives.”