Health Research Report
90th Issue 26 SEP 2010
Compiled By Ralph Turchiano
Editors Top Five:
1. Eating broccoli could guard against arthritis
2. Vitamin C rapidly improves emotional state of acutely hospitalized patients, say LDI researchers
3. Chromium picolinate may lessen inflammation in diabetic nephropathy
4. New study: Serious gaps in medical journals’ disclosure of physician relationships with industry
5. Children’s brain development is linked to physical fitness
In this Issue:
1. Study finds that sorghum bran has more antioxidants than blueberries, pomegranates
2. Early prostate cancer detection, screening: No benefit for men with low baseline PSA value
3. Repeated antibiotic use alters gut’s composition of beneficial microbes, Stanford study shows
4. New study: Serious gaps in medical journals’ disclosure of physician relationships with industry
5. Carnegie Mellon research: How doctors rationalize acceptance of industry gifts
6. New task force report on bisphosphonate use and atypical femur fractures in osteoporosis patients
7. News release Watercress may ‘turn off’ breast cancer signal
8. Eating broccoli could guard against arthritis
9. Aerobic Exercise Relieves Insomnia
10. New study finds milk drinkers may have a healthy weight advantage
11. Children’s brain development is linked to physical fitness
12. Most Americans Don’t Get Daily Exercise
13. Drink Milk and Lose More Weight
14. Cocaine and ecstasy detected in waters of the L’Albufera in Valencia
15. Chromium picolinate may lessen inflammation in diabetic nephropathy
16. Study: Doctors overprescribe antibiotics for respiratory infections
17. Declining breast cancer incidence in Canada with declining HRT usage
18. Vitamin C rapidly improves emotional state of acutely hospitalized patients, say LDI researchers
19. Why the EU banned Avandia but the FDA didn’t
20. Amgen recalls anemia drugs due to glass flakes
Public release date: 13-Sep-2010
Study finds that sorghum bran has more antioxidants than blueberries, pomegranates
Athens, Ga. – A new University of Georgia study has found that select varieties of sorghum bran have greater antioxidant and anti-inflammatory properties than well-known foods such as blueberries and pomegranates.
Researchers measured polyphenolic compounds, which naturally occur in plants to help fight against pests and disease, and found that the black and sumac varieties of sorghum have significant levels of antioxidants. Many fruits also contain these compounds, they said, though sorghum bran may prove to be the richest and cheapest source.
“Since most human chronic disease states are associated with chronic inflammation and high oxidative stress, a food ingredient such as sorghum bran could potentially make certain processed foods better for a healthy diet,” said study co-author DianeHartle, director of the UGA Nutraceutical Research Laboratory and an associate professor in the College of Pharmacy.
Hartle and her colleagues, whose results appear in the current issue of the Journal of Medicinal Food, measured the degree to which extracts from four different varieties of sorghum reduced inflammation in mice. They found that black and sumac varieties showed significantly higher levels of polyphenolic content and antioxidant levels than the two low-tannin varieties tested, which did not reduce inflammation.
The authors found that levels of polyphenolic compounds in the high-tannin sorghum varieties ranged from 23 to 62 mg of polyphenols per gram. For comparison, blueberries contain approximately 5 mg of polyphenolics per gram, while pomegranate juice contains 2 to 3.5 mg per gram.
The U.S. is the largest producer of sorghum in the world. Most of the sorghum grown, however, is a low-tannin variety that is fed to cattle and poultry or used to manufacture ethanol to fuel cars. “High-tannin sorghums can be of greater economy to manufacturers because of the current cost of berry and fruit sources of similar plant-based chemicals,” said study co-author Phillip Greenspan, associate professor in the UGA College of Pharmacy.
High-tannin sorghum bran products have not been available in supermarket foods until recently. The researchers said they hope to generate interest in sorghum bran or itsextract as an additive to food and beverages. Sorghum bran extract could be added to a variety of foods and beverages as a liquid concentrate or dried powder. The Great Plains area of the U.S. is the largest worldwide producer of sorghum, and the researchers said that the combination of its low price and high antioxidant and anti-inflammatory properties will make it widely useful as an inexpensive and nutritional food additive.
The researchers have already experimented with adding the extract to apple juice to make it an affordable alternative to pomegranate juice and other antioxidant-rich products. “We’re hoping that some company decides to extract this bran and pull these chemicals out and put the extract into a beverage that can help you fight disease rather than promote disease,” Hartle said.
Study co-author James Hargrove, associate professor in the UGA College of Family and Consumer Sciences, added that high-tannin sorghum has more antioxidant phytochemicals than other brans such as rice, wheat and oats, whose phenolic content and antioxidant values are low. He and Hartle said that the use of sorghum can become a way to reintroduce a quality food to many products that now use bleached, refined flour.
“Sorghum bran not only provides the fiber but gives you a real medicinal punch at the same time because it delivers a lot of other chemicals that a berry would give you,” Hartle said.
Public release date: 13-Sep-2010
Early prostate cancer detection, screening: No benefit for men with low baseline PSA value
Men aged 55 to 74 years who have low baseline blood levels of prostate specific antigen (PSA) are not likely to benefit from further screening and treatment. That is the conclusion of a new study published early online in Cancer, a peer-reviewed journal of the American Cancer Society. The aim of the study is to help physicians and patients weigh the pros and cons of prostate cancer screening and early detection.
Prostate cancer is the most commonly diagnosed malignancy and the third leading cause of death from cancer in men in Western countries. While a man in the United State has about a one in six chance of being diagnosed with prostate cancer during his lifetime, his
risk of dying from the disease is relatively low (about one in 36).
Pim van Leeuwen, MD, of the Erasmus University Medical Centre in Rotterdam, the Netherlands, led a team that tried to identify if the baseline PSA can predict which men have most benefit from additional screening. The investigators compared the incidence of prostate cancer with deaths from prostate cancer as related to PSA levels in 43,987 men aged 55 to 74 years who were enrolled between 1993 and 1999 in the European Randomized Study of Screening for Prostate Cancer (ERSPC) study in the Netherlands, Sweden, and Finland. An additional 42,503 men in the same age range from Northern Ireland who had their PSA levels measured between 1994 and 1999 were also included. All men had PSA levels that were under 20 ng/ml at the start of the study, and were followed for prostate cancer incidence and causes of death through 2006.
A total of 5,861 prostate cancer cases arose during the study period, and prostate cancer death rates were highest in men with high PSA levels at the start of the study. The researchers found that for men with PSA levels between zero and 1.9 ng/ml, a total of 24,642 men would need to be screened and 724 cases of prostate cancer would need to be treated to prevent just one death from prostate cancer. For men with PSA levels between 10 and 19.9 ng/ml, the benefits of screening and treatment were more favorable: a total of 133 men would need to be screened to prevent one death from prostate cancer.
This study indicates that a man’s PSA level before diagnosis is a strong predictor for his risk of dying from prostate cancer. For men aged 55 to 74 years who have low PSA levels, the benefits of aggressive follow-up testing and treatment seem limited. Without providing benefits, they may increase prostate cancer diagnoses and lead to overtreatment and increased costs.
“The greatest benefits of early detection programs may be when men, aged 55-74 years, are diagnosed and treated when their serum PSA is in the range 4.0-9.9 ng/ml or 10.0-19.9 ng/ml. Furthermore, following research efforts that recommend more intensive PSA based screening by lowering the PSA cut-off may greatly increase the number of men that need additional investigations and treatment, whilst having little effect on the reduction of prostate cancer mortality,” the authors wrote.
Dr. van Leeuwen cautioned that,”the results presented in the current study are limited due to the relatively short follow-up. Consequently the pros of early detection and screening may increase with longer the follow-up while the cons may relatively decrease.”
Public release date: 13-Sep-2010
Repeated antibiotic use alters gut’s composition of beneficial microbes, Stanford study shows
STANFORD, Calif. – Repeated use of an antibiotic that is considered generally benign, because users seldom incur obvious side effects, induces cumulative and persistent changes in the composition of the beneficial microbial species inhabiting the human gut, researchers at the Stanford University School of Medicine have found.
By a conservative estimate, something like 1,000 different varieties of microbes coexist harmoniously within a typical healthy person’s gut, said David Relman, MD,professor of medicine and of microbiology and immunology at the medical school and chief of the infectious diseases division at the Veterans Affairs Palo Alto Health Care System. Relman is the senior author of a paper, which will appear online Sept. 13 in Proceedings of the National Academy of Sciences.
The study examined the effects of ciprofloxacin (trade name Cipro), an antibiotic that is widely prescribed for intestinal, urinary and a variety of systemic infections. In an earlier, short-term study, Relman’s group had concluded that people’s intestinal microbial communities seem to bounce back reasonably well within weeks after a five-day regimen of ciprofloxacin. This new study involved two courses of antibiotic administration, six months apart, and it revealed more-subtle, long-term effects of ciprofloxacin use – such as the replacement of multiple resident bacterial species by other, closely related varieties and the occasional complete eradication of a species.
The infrequent occurrence of easily visible side effects such as bloating and diarrhea from ciprofloxacin use has given rise to an assumption that the drug spares most beneficial gut-dwelling bacteria. Overall similarities between pre-regimen gut bacterial strains and their post-regimen replacements explain why such side effects aren’t typically seen after ciprofloxacin use. Still, the more nuanced differences between the pre-existing communities and those that appear in the wake of this repeated disturbance present a new set of problems, said Relman, who is also the Thomas C. and Joan M. Merigan Professor at the medical school. A bacterial species whose presence was lost or diminished may have been performing a valuable job – for example, secreting a protein that’s toxic to a particular pathogen – that is shirked by its replacement. The abandoned function might not be noticed until, perhaps, years later when the pathogen in question invaded the person’s gut.
While the study’s findings shouldn’t be interpreted to mean that ciprofloxacin is dangerous and should be avoided, Relman said, they do raise questions about possiblelong-term effects of antibiotic administration, in addition to concerns about spurring the evolution of drug-resistant organisms. The new findings underscore the desirability of finding ways to pinpoint not just which bacteria have been lost or whose numbers were diminished by an antibiotic, but also which important beneficial functions performed by the patient’s gut microbial community as a whole have been impaired – such as signaling cells of the intestinal lining, which are constantly turning over, to maintain an appropriate barrier against ingested toxic compounds, or secreting anti-inflammatory substances that may prevent allergic or autoimmune diseases.
For this study, the Stanford scientists collected more than 50 stool samples from each of three healthy adult females over a period of 10 months. Then they used advanced, molecular techniques to count the number of different microbial species represented in each sample, as well as relative population sizes of the different species in that sample.
Twice during this 10-month period, the researchers perturbed their subjects’ gut ecosystems by giving them five-day courses of ciprofloxacin at a standard dose. During the first course, overall bacterial populations in each subject – which had previously waxed and waned but, on the whole, been quite stable – plummeted and remained depressed for about a week. Roughly one-third to one-half of the resident species’ populations declined, with some disappearing entirely. A few originally less-abundantspecies grew in number, as they filled in the ecological niche abandoned by bugs adversely affected by the drug.
Within a week after the first course’s completion, two of the three subjects’ internal microbial ecosystems had largely returned to a state fairly similar to that before the regimen, as measured by the broad classes to which the microbial constituents belonged.
One subject’s overall ecosystem, however, still had not recovered even by that rough measure a full six months later.
The second course of antibiotic administration produced a stronger effect. “Even the one subject whose gut bacterial community fully recovered after the first ciprofloxacin course experienced an incomplete recovery after the second one,” saidRelman. The communities in the other two subjects partially recovered from the second course, but never returned to their original state. Inessence, each subject’s community of gut-dwelling microbes shifted to a new, “alternative” state and remained in that state for at least two months after the second antibiotic course had been completed. Thus, all three subjects experienced significant and lasting changes in the specific membership of their internal microbial communities at the end of the 10-month study period.
“Ecologists have found that an ecosystem, such as a wildlife refuge, that is quite capable of rebounding from even huge occasional perturbations – forest fire, volcanic eruption, pests – may yet be undone by too rapid a series of such perturbations,” said Les Dethlefsen, PhD, a research scientist in Relman’s lab and the study’s first author. “In the same way, recurring antibiotic use may produce a cumulative effect on our internal microbial ecosystems with potentially debilitating, if as yet unpredictable, consequences.”
“It’s as if your beneficial bacteria ‘remember’ the bad things done to them in the past,” said Relman. “Clinical signs and symptoms may be the last thing to show up.”
The precise counts of gut-dwelling microbes in this study were made possible by a new technique, pioneered in recent years by Relman and others. The older method – growing the microbes in culture – simply doesn’t work for many species and, even when it does,
rare species are often swamped by more common ones and don’t get counted. The new technique reads short, telltale DNA snippets that distinguish microbes both from human cells and one from another. This allowed the Stanford researchers to assess both the total number of different microbial varieties and the relative size of each variety’s population.
Similar techniques now make it possible to assess, before and after antibiotic administration, the abundance in a patient’s gut of microbial genes known to code for important functions performed by one or more members of the patient’s gut community, Relman said. In the future, if it becomes known that a key function has been impaired, clinicians might perhaps restore that function by prescribing specific probiotics or nutrients that encourage the return of appropriate beneficial bugs.
Public release date: 13-Sep-2010
New study: Serious gaps in medical journals’ disclosure of physician relationships with industry
Readers aren’t informed about conflicts of interest that could affect patient care, even when sums involved are over $1 million
(New York, NY) Nearly half the surgeons who made at least $1 million in payments from orthopedic device companies did not have that relationship published in their scientific articles, according to a study released today in the on-line edition of the Archives of Internal Medicine. The study shows that readers are not being adequately informed about conflicts of interest even when the funds involved are significant.
The study, conducted by researchers at the New York-based Institute on Medicine as a Profession (IMAP), is the first of its kind to use company records to check on the accuracy of disclosure information listed in medical journals. The five manufacturing firms studied disclosed the dollars they paid to consultants in a public database. IMAP researchers searched the database and compared the list to the financial disclosure information, if any, listed in the journal articles.
“The findings raise troubling questions about undisclosed payments or royalties and other fees from medical device companies that could lead to biased scientific conclusions,” says senior author David Rothman, president of IMAP (www.imapny.org),a think tank based at the Columbia University College of Physicians & Surgeons in New York City. He co-authored the study with IMAP colleagues Susan Chimonas, associate research scholar and Zachary Frosh, research associate.
The authors note that journal editors typically don’t check multiple databases that are now available and simply rely on the honor system. They expect a researcher to disclose all conflicts but do not verify if the information is complete and accurate.
Rothman and colleagues argue that full disclosure in medical journal articles is vital.
“These articles constitute a permanent scientific record that is used by practicing physicians, guideline committees, purchasers and patients to evaluate treatment options. Journal editors, reviewers and readers must be fully informed about authors’ industry relationship to consider the potential for bias,” they write.
IMAP compared 2007 physician payment information from five orthopedic device companies with disclosure of company payments in journal articles. These five companies (Biomet, DePuy Orthopedics, Smith & Nephew, Stryker, and Zimmer) made a total of 1,654 payments that amounted to $248 million in 2007 for consulting, honoraria or other payments for services. The analysis also showed that payments to 41 orthopedic surgeon researchers ranged from just over $1 million to a high of $8.8 million, representing 62 percent of all company expenditures.
These highly paid orthopedic consultants became the focus of the analysis because of the size of their payments. The IMAP team homed in on 95 articles published in the scientific literature after researchers received their large payments and found that fewer than half of the journal articles disclosed a financial relationship between the author and company.
In no case did journal articles reveal how substantial the payments were to the authors. Almost all of articles were directly related to a device, like a hip implant, made by the company. This study focused on orthopedic surgeons but other studies suggest other medical specialists also fail to have their industry ties published.
Rothman says consumers should be concerned. “Patients have a real stake in transparency. You want to make sure that the surgeon is choosing the device that is best for you and that your doctor is not getting biased information.”
Growing data show patients are increasingly wary of physician industry ties. A recent study by Consumer Reports showed that half of patients thought that gifts from drug companies influenced their doctor’s choice of drugs.
Rothman says editors and others need to start using the company’s data bases to get information about physician-industry relationships. No less than 15 drug and device companies are now putting payment information on their websites, says Rothman, a practice that will be accelerated by the Patient Protection and Affordable Care Act. Under the new health reform law, all drug and device manufacturers will have to report payments to physicians in a searchable public database by 2013. Editors, consumers, deans of medical schools and others will then be able to search for any doctor’s name and a list of payments from drug or medical device manufacturers.
Having a sunshine policy enshrined in law will make a big difference in promoting transparency, says Rothman. “The next generation of physicians should know that every nickel they take from industry is going to be made public.”
Public release date: 14-Sep-2010
Carnegie Mellon research: How doctors rationalize acceptance of industry gifts
PITTSBURGH— Despite heightened awareness about the undue influence that gifts from pharmaceutical companies can have on doctors’ prescribing practices, and despite expanding institutional conflict-of-interest policies and state laws targeted at preventing such practices, companies continue to reward doctors for prescribing their drugs with gifts ranging from pens and paper, to free dinners and trips. A new study by two researchers at Carnegie Mellon University, published in the Journal of the American Medical Association, helps to explain how doctors rationalize acceptance of such gifts, which author George Loewenstein, the Herbert A. Simon Professor of Economics and Psychology, describes as “barely described bribes.” The study found that physicians rationalize acceptance of these gifts as a form of reward for the sacrifices they made obtaining their education.
Three hundred and one pediatric and family medicine residents answered a series of questions that asked about the acceptability of receiving different types of gifts from pharmaceutical companies. Before completing the survey, however, one group of doctors were first asked about the sacrifices they had made in getting their medical education. A second group were also first asked these sacrifice questions and then were asked whether such sacrifices could potentially justify acceptance of gifts (a rationalization that explicitly introduces the idea that this might be the case) before filling out the gift acceptability questions. A control group was asked about the acceptability of receiving gifts without being first asked about personal sacrifices or being cued with a potential rationalization.
Reminding physicians first of their medical training burdens more than doubled their willingness to accept gifts — from 21.7 percent to 47.5 percent, and suggesting the potential rationalization further increased their willingness to accept the gifts — to 60.3 percent.The impact of the suggested rationalization was surprising because,when asked whether their hardships justified taking gifts, most respondents said it did not. Sunita Sah, the study’s lead author and a physician herself who is completing her PhD at Carnegie Mellon’s Tepper School of Business, commented that “this finding suggests that even justifications that people don’t accept at a conscious level can nonetheless help them to rationalize behavior that they otherwise might find unacceptable.”
Both authors agree that the implications of the study are straightforward. “Given how easy it is for doctors to rationalize accepting gifts, which, from other research, we know influences their prescribing behavior, the inescapable conclusion is that gifts should simply be prohibited,” said Loewenstein, who has done extensive researchand writing on the role of human psychology in exacerbating conflicts of interest.
“Given the powerful human capacity to rationalize what benefits us,” Sah added, “it is unlikely that we will be able to make a dent in the problem by, for example, educating physicians about the risks posed by conflicts.”
Public release date: 14-Sep-2010
New task force report on bisphosphonate use and atypical femur fractures in osteoporosis patients
Expert panel calls for additional product labeling, international patient registry
Washington, DC, SEPTEMBER 14, 2010– A widely prescribed class of drugs is highly effective in reducing common bone fractures in people with osteoporosis, but an expert panel announced today that these same drugs – when used long term – may be related to unusual but serious fractures of the thigh bone. In the most comprehensivescientific report to date on the topic, the task force reviewed 310 cases of “atypical femur fractures,” and found that 94 percent (291) of patients had taken the drugs, most for more than five years. The task force members emphasized that atypical femurfractures represent less than one percent of hip and thigh fractures overall and therefore are very uncommon.
The task force was convened by the American Society of Bone and Mineral Research – the leading scientific organization on bone science – in the wake of growing concern about the connection between these drugs, called bisphosphonates, and unusual femur fractures. The Food and Drug Administration (FDA) said in March that it would await the report before making recommendations about bisphosphonates and has received a copy of the task force’s report. The report was published in the Journal of Bone and Mineral Research.
“For the vast majority of patients with osteoporosis, these drugs are an important weapon against fractures and their benefits far outweigh the risks of using them,” said task force co-chair and lead author Elizabeth Shane, M.D., of Columbia University. “Most of the patients who experienced these atypical femur fractures had been taking bisphosphonates for more than five years. However, we are concerned that there may be a relationship between these fractures and long-term bisphosphonate use and, although the risk is low, we want to make sure that people know about the warning signs,” she said.
The task force is calling for additional product labeling, better identification and tracking of patients experiencing these breaks, and more research to determine whether and how these drugs cause the serious but uncommon fractures.
The international, multi-disciplinary task force conducted an extensive review of both published and unpublished data and interviewed scientists at pharmaceutical companies that sell the drug and at the FDA, which maintains the MedWatch database that tracks reported side effects of approved medications.
The task force expressed concern about the lack of awareness of atypical femur fractures, their warning signs and their association with long-term use of bisphosphonates. More than half of patients with atypical femur fractures reported groin or thigh pain for a
period of weeks or months before fractures occurred, according to the report. More than a quarter of patients who experienced atypical femur fractures in one leg experienced a fracture in the other leg as well.
Millions of people, primarily women, have been treated with bisphosphonates since they were approved in 1995. Bisphosphonates include the drugs Aclasta, Actonel, Aredia, Bondronat, Boniva, Didronel, Fosamax, Fosavance, Reclast, Skelid, and Zometa. Bone diseases, such as osteoporosis, drastically affect the way people function. Individuals who suffer broken bones as a result of osteoporosis can suffer severe pain, loss of height and stooped posture that can affect breathing and digestion. One in five patients who walked before their hip fracture needs long-term care afterward. And although the rate of hip fractures is two to three times higher in women, after one year, the death rate in men is nearly twice as high.
Among the task force recommendations:
•Product labeling should be changed to alert health professionals and patients to the possibility of atypical femur fractures for patients on bisphosphonate therapy and the associated warning signs; cases should be reported to the FDA MedWatch program.
•New diagnostic and procedural codes should be developed for atypical femur fractures to improve the quality of case reporting and enable better review of medical records.
•An international registry of patients experiencing atypical femur fractures should be established to track cases and facilitate future research.
“We know that bisphosphonates prevent many, many common fractures. For this reason, we want to emphasize that patients should not stop taking these drugs because they are afraid of the much more uncommon femur fractures. They should talk to their health professionals about their concerns and should let them know if they experience any new groin or thigh pain. Patients can also report any side effects of these medications to the FDA by phone or online,” Shane said.
“Health professionals should reserve bisphosphonates for patients with certain cancers, Paget’s disease of bone, and patients with osteoporosis who are at high risk of having a fracture. Drug labels should include information about this side effect. Although the risks are very low, health professionals should know the warning signs of atypical femur fractures and regularly ask patients on these drugs about groin or thigh pain. They also should assess annually whether this therapy is appropriate for each patient,” she added.
Public release date: 14-Sep-2010
News releaseWatercress may ‘turn off’ breast cancer signal
New scientific research from the University of Southampton has revealed that a plant
compound in watercress may have the ability to suppress breast cancer cell development by ‘turning off’ a signal in the body and thereby starving the growing tumour of essential blood and oxygen.
The research, unveiled at a press conference today (14 September 2010), shows that the watercress compound is able to interfere with the function of a protein which plays a critical role in cancer development.
As tumours develop they rapidly outgrow their existing blood supply so they send out signals which make surrounding normal tissues grow new blood vessels into the tumour which feed them oxygen and nutrients.
The research, led by Professor Graham Packham of the University of Southampton, shows that the plant compound (called phenylethyl isothiocyanate) found in watercress can block this process, by interfering with and ‘turning off’ in the function of a protein called Hypoxia Inducible Factor (HIF).
Professor Packham, a molecular oncologist at the University of Southampton, comments: “The research takes an important step towards understanding the potential health benefits of this crop since it shows that eating watercress may interfere with a pathway that has already been tightly linked to cancer development.
“Knowing the risk factors for cancer is a key goal and studies on diet are an important part of this. However, relatively little work is being performed in the UK on the links between the foods we eat and cancer development.”
Working with Barbara Parry, Senior Research Dietician at the Winchester and Andover Breast Unit, Professor Packham performed a pilot study in which a small group of breast cancer survivors, underwent a period of fasting before eating 80g of watercress (a cereal bowl full) and then providing a series of blood samples over the next 24 hours.
The research team was able to detect significant levels of the plant compound PEITC in the blood of the participants following the watercress meal, and most importantly, could show that the function of the protein HIF was also measurably affected in the blood cells of the women.
The two studies, which have been published in the British Journal of Nutrition and Biochemical Pharmacology, provide new insight into the potential anti-cancer effects of watercress, although more work still needs to be done to determine the direct impact watercress has on decreasing cancer risk.
Watercress Alliance member Dr Steve Rothwell says: “We are very excited by the outcome of Professor Packham’s work, which builds on the body of research which supports the idea that watercress may have an important role to play in limiting cancer development.”
A summary of the research has been accepted for inclusion in the Breast Cancer Research Conference which is taking place in Nottingham from 15 to 17 September.
Breast cancer is the most common cancer in women in the western world and currently affects approximately 1 in 9 women during their lifetime.
Public release date: 15-Sep-2010
Eating broccoli could guard against arthritis
Scientists at the University of East Anglia (UEA) are launching a groundbreaking new project to investigate the benefits of broccoli in the fight against osteoarthritis.
Initial laboratory research at UEA has found that a compound in broccoli called sulforaphane blocks the enzymes that cause joint destruction in osteoarthritis – the most common form of arthritis.
Broccoli has previously been associated with reduced cancer risk but this is the first major study into its effects on joint health.
With funding from both Arthritis Research UK and the Diet and Health Research Industry Club (DRINC), the £650,000 project will explore how sulforaphane may act to slow or prevent the development of osteoarthritis. It will prepare the way for the first patient trials and could lead to safe new ways of preventing and treating this painful disease.
Sulforaphane is a bioactive compound found in cruciferous vegetables, particularly broccoli. Eating broccoli leads to a high level of sulforaphane in the blood, but scientists don’t yet know if the sulforaphane gets into joints in sufficient amounts to be effective. This is one of the things that the UEA team hopes to discover.
Osteoarthritis is the leading cause of disability in the UK where it affects around six million people. It is a degenerative joint disease which gradually destroys the cartilage in the joints, particularly in the hands, feet, spine, hips and knees of older people. There is currently no effective treatment other than pain relief or joint replacement.
Prof Ian Clark, of UEA’s School of Biological Sciences, who is leading the research said: “The UK has an aging population and developing new strategies for combating age-related diseases such as osteoarthritis is vital – to improve the quality of life for sufferers but also to reduce the economic burden on society.”
As part of the three-year project, the UEA team will also investigate the effects of other dietary compounds on osteoarthritis, including diallyl disulphide which is found in high amounts in garlic and also appears to slow the destruction of cartilage in laboratory models.
Public release date: 15-Sep-2010
Aerobic Exercise Relieves Insomnia
Boosting cardiovascular fitness improves sleep, vitality and mood for insomniacs
CHICAGO — The millions of middle-aged and older adults who suffer from insomnia have a new drug-free prescription for a more restful night’s sleep. Regular aerobic exercise improves the quality of sleep, mood and vitality, according to a small but significant new study from Northwestern Medicine.
The study is the first to examine the effect of aerobic exercise on middle-aged and older adults with a diagnosis of insomnia. About 50 percent of people in these age groups complain of chronic insomnia symptoms.
The aerobic exercise trial resulted in the most dramatic improvement in patients’ reported quality of sleep, including sleep duration, compared to any other non-pharmacological intervention.
“This is relevant to a huge portion of the population,” said Phyllis Zee, M.D., director of the Sleep Disorders Center at Northwestern Medicine and senior author of a paper to be published in the October issue of Sleep Medicine. The lead author is Kathryn Reid, research assistant professor at Feinberg.
“Insomnia increases with age,” Zee said. “Around middle age, sleep begins to change dramatically. It is essential that we identify behavioral ways to improve sleep. Now we have promising results showing aerobic exercise is a simple strategy to help people sleep better and feel more vigorous.”
The drug-free strategy also is desirable, because it eliminates the potential of a sleeping medication interacting with other drugs a person may be taking, Reid said.
Sleep is an essential part of a healthy lifestyle, like nutrition and exercise, noted Zee, a professor of neurology, neurobiology, and physiology at Northwestern University Feinberg School of Medicine and a physician at Northwestern Memorial Hospital.
“By improving a person’s sleep, you can improve their physical and mental health,” Zee said. “Sleep is a barometer of health, like someone’s temperature. It should be the fifth vital sign. If a person says he or she isn’t sleeping well, we know they are more likely to be in poor health with problems managing their hypertension or diabetes.”
The study included 23 sedentary adults, primarily women, 55 and older who had difficulty falling sleep and/or staying asleep and impaired daytime functioning. Women have the highest prevalence of insomnia. After a conditioning period, the aerobic physical activity group exercised for two 20-minute sessions four times per week or one 30-to-40-minute session four times per week, both for 16 weeks. Participants worked at 75 percent
of their maximum heart rate on at least two activities including walking or using a stationary bicycle or treadmill.
Participants in the non-physical activity group participated in recreational or educational activities, such as a cooking class or a museum lecture, which met for about 45 minutes three to five times per week for 16 weeks.
Both groups received education about good sleep hygiene, which includes sleeping in a cool, dark and quiet room, going to bed the same time every night and not staying in bed too long, if you can’t fall asleep.
Exercise improved the participants’ self-reported sleep quality, elevating them from a diagnosis of poor sleeper to good sleeper. They also reported fewer depressive symptoms, more vitality and less daytime sleepiness.
“Better sleep gave them pep, that magical ingredient that makes you want to get up and get out into the world to do things,” Reid said.
The participants’ scores on the Pittsburgh Sleep Quality Index dropped an average of 4.8 points. (A higher score indicates worse sleep.) In a prior study using t’ai chi as a sleep intervention, for example, participants’ average scores dropped 1.8 points.
“Exercise is good for metabolism, weight management and cardiovascular health and now it’s good for sleep,” Zee said.
The research was funded by the National Institute on Aging.
Public release date: 15-Sep-2010
New study finds milk drinkers may have a healthy weight advantage
Research suggests boosting key milk nutrients calcium and vitamin D could aid weight loss
Now there’s a new reason to grab a glass of milk when you’re on diet, suggests a new study published in the American Journal of Clinical Nutrition. In a 2-year weight loss study, milk drinkers had an advantage over those who skipped the milk. Israeli researchers found that adults who drank the most milk (nearly 2 glasses per day) and had the highest vitamin D levels at 6 months, lost more weight after 2 years than those who had little or no milk or milk products — nearly 12 pounds weight loss, on average.
Researchers also found that each additional 6-ounce serving of milk or milk products (about 3/4 of a glass of milk) was associated with 10 pounds successful weight loss above the average, at 6 months.
More than 300 overweight or at risk men and women ages 40 – 65 participated in the study following low-fat, Mediterranean or low-carb diets for 2 years. Regardless of diet, researchers found participants with the highest dairy calcium intake 6 months into the study (averaging about 580mg per day – the amount in nearly 2 glasses of milk) lost about 12 pounds at the end of the 2 years, compared to about 7 pounds for those with the lowest dairy calcium intake (averaging about 150mg, or about half of a glass).
Beyond calcium, the researchers also found that vitamin D levels independently affected weight loss success and in line with previous research, milk and milk products were the top contributors to vitamin D in the diets of the study participants.
Despite the potential health benefits, many Americans are still not getting the recommended 400IU of vitamin D each day – the amount in four glasses of fat free orlowfat milk. This D-ficiency may put their health at risk, for healthy weight and beyond. Well known for its role in keeping bones strong, vitamin D is now being hailed for so much more. Emerging science suggests vitamin D may also help protect against diabetes, hypertension, heart disease and certain cancers. It also supports a healthy immune system.
Fat free milk is packed with nine essential nutrients Americans need, including calcium and vitamin D, and contains 80 calories per 8-ounce serving. Research suggests eating right, getting active and drinking the recommended three glasses of lowfat or fat free milk daily can help you maintain a healthy weight.
Public release date: 15-Sep-2010
Children’s brain development is linked to physical fitness
CHAMPAIGN, lll. – Researchers have found an association between physical fitness and the brain in 9- and 10-year-old children: Those who are more fit tend to have a bigger hippocampus and perform better on a test of memory than their less-fit peers.
A bigger hippocampus in nine- and ten-year-old children appears to boost their performance on a relational memory task, said University of Illinois doctoral student Laura Chaddock. | Photo courtesy Laura ChaddockThe new study, which used magnetic resonance imaging to measure the relative size of specific structures in the brains of 49 child subjects, appears in the journal Brain Research.
“This is the first study I know of that has used MRI measures to look at differences in brain between kids who are fit and kids who aren’t fit,” said University of Illinois psychology professor and Beckman Institute director Art Kramer, who led the study with doctoral student Laura Chaddock and kinesiology and community health professor Charles Hillman. “Beyond that, it relates those measures of brain structure to cognition.”
The study focused on the hippocampus, a structure tucked deep in the brain, because it is known to be important in learning and memory. Previous studies in older adults and in animals have shown that exercise can increase the size of the hippocampus. A bigger hippocampus is associated with better performance on spatial reasoning and other cognitive tasks.
“In animal studies, exercise has been shown to specifically affect the hippocampus, significantly increasing the growth of new neurons and cell survival, enhancing memory and learning, and increasing molecules that are involved in the plasticity of the brain,” Chaddock said.
Rather than relying on second-hand reports of children’s physical activity level, the researchers measured how efficiently the subjects used oxygen while running on a treadmill.
“This is the gold standard measure of fitness,” Chaddock said.
The physically fit children were “much more efficient than the less-fit children at utilizing oxygen,” Kramer said.
When they analyzed the MRI data, the researchers found that the physically fit children tended to have bigger hippocampal volume – about 12 percent bigger relative to total brain size – than their out-of-shape peers.
The children who were in better physical condition also did better on tests of relational memory – the ability to remember and integrate various types of information – than their less-fit peers.
“Higher fit children had higher performance on the relational memory task, higher fit children had larger hippocampal volumes, and in general, children with larger hippocampal volumes had better relational memory,” Chaddock said.
Further analyses indicated that a bigger hippocampus boosted performance on the relational memory task.
“If you remove hippocampal volume from the equation,” Chaddock said, “the relationship between fitness and memory decreases.”
The new findings suggest that interventions to increase childhood physical activity could have an important effect on brain development, Kramer said.
“We knew that experience and environmental factors and socioeconomic status all impact brain development,” he said.
“If you get some lousy genes from your parents, you can’t really fix that, and it’s not easy to do something about your economic status. But here’s something that we can do
something about,” Kramer said.
Public release date: 15-Sep-2010
Most Americans Don’t Get Daily Exercise
SATURDAY, Sept. 18 (HealthDay News) — Only about 5 percent of American adults do some type of vigorous physical activity on any given day, according to the results of a new study.
Researchers analyzed 2003-2008 data from nearly 80,000 participants, aged 20 and older, in the American Time Use Survey, a national telephone-based poll that asked people what they did in the preceding 24 hours.
Most respondents reported sedentary activities such as eating and drinking (95.6 percent) and watching television/movies (80.1 percent), or light activities such as washing, dressing and grooming (78.9 percent), and driving a car, truck or motorcycle (71.4 percent).
The most frequently reported moderate activities were food and drink preparation (25.7 percent) and lawn, garden and houseplant care (10.6 percent), lead investigator Catrine Tudor-Locke, director of the Walking Behavior Laboratory at Pennington Biomedical Research Center in Baton Rouge, La., and colleagues found.
Only 5 percent of respondents reported vigorous physical activities, including using cardiovascular exercise equipment (2.2 percent) and running (1.1 percent).
The survey findings are published online and in the October print issue of the American Journal of Preventive Medicine.
“On any given day, most U.S. adults reported performing predominantly sedentary and light activities. The greatest prevalence for reported moderate activities was food and drink preparation for both men (12.8 percent) and women (37.6 percent),” the authors wrote in the report.
Public release date: 22-Sep-2010
Drink Milk and Lose More Weight
Regardless of Diet, Study Participants Who Consumed the Most Milk Lost the Most Weight
BEER-SHEVA, ISRAEL, September 21, 2010 — A new weight loss study conducted by Ben-Gurion University of the Negev (BGU) researchers reveals that dieters who consumed milk or milk products lost more weight on average than those who consumed little to no milk products.
Regardless of diet, researchers also found participants with the highest dairy calcium intake, equal to 12 oz. of milk or other dairy products (580 mg of dairy calcium), lost about 12 pounds (6 kg.) at the end of the
two years. In comparison, those with the lowest dairy calcium intake averaging about 150 mg dairy calcium, or about half of a glass, only lost seven pounds on average. The study was published in the current issue of the American Journal of Clinical Nutrition.
Beyond calcium, the researchers also found that blood levels of vitamin D independently affected weight loss success. Vitamin D levels increased among those who lost more weight. The dietary intervention study also confirmed other research that overweight participants have lower blood levels of vitamin D.
More than 300 overweight men and women, aged 40 to 65, participated in the study evaluating low fat, Mediterranean or low-carb diets for two years. Dr. Danit Shahar, of BGU’s S. Daniel Abraham Center for Health and Nutrition and the Faculty of Health Sciences, led the study. It was part of the Dietary Intervention Randomized Control Trial (DIRECT) conducted at the Nuclear Research Center in Israel.
According to Dr. Shahar, “It was known that over-weight people had lower levels of serum vitamin D but this is the first study that actually shows that serum Vitamin D increased among people who lost weight. This result lasted throughout the two years that the study was conducted, regardless of whether they were on a low-carb, low fat or Mediterranean diet.”
Vitamin D increases calcium absorption in the bloodstream and in addition to sun exposure can be obtained from fortified milk, fatty fish and eggs. Americans generally consume less than the recommended daily requirement of Vitamin D which is found in four glasses of milk (400 international units).
The study was supported by the Israel Ministry of Health and the Israel Dairy Council, the Israel Chief Scientist Office, German Research Foundation and the Dr. Robert C. and Veronica Atkins Research Foundation.
Dairy Calcium Intake, Serum Vitamin D, and Successful Weight Loss. American Journal of Clinical Nutrition. 2010. Published ahead of print.
Public release date: 22-Sep-2010
Cocaine and ecstasy detected in waters of the L’Albufera in Valencia
The water in the canals and irrigation channels in the L’Albufera Natural Park in Valencia contain cocaine, ecstasy and a further six drugs. This has been confirmed by a study carried out by researchers from the University of Valencia (UV), who have issued a warning about the continued presence of these substances on wildlife and human health.
“The results confirm the presence of drugs such as cocaine, amphetamines, codeine, morphine and cannabis in the surface waters of the L’Albufera National Park at levels ranging between 0.06 and 78.78 nanograms/litre”, Yolanda Picó, lead author of the study and a senior professor in the Departmentof Nutrition and Bromatology at the UV, tells SINC.
Scientists from this university and the Desertification Research Centre (CSIC-UV-GV) analysed the presence of 14 kinds of illegal drugs – including heroin, cocaine and ecstasy – in 16 canals and irrigation channels in the natural park. The study looked for the residue these drugs leave behind in human urine after they have been taken, and which end up in the water.
The results, published in the journal Analytical and Bioanalytical Chemistry, positively showed the presence of eight kinds of drugs, particularly cocaine and ecstasy. “Cocaine and its metabolites (such as benzoylecgonine) were ubiquitous in all the samples taken, while ecstasy (3.4-methylendioximetamphetamine, or MDMA) was also found very frequently”, Picó explains.
The greatest drug concentration and frequency was found in the north of the park, above all in the area of the Poyo ravine. Waste water is regularly discharged in this area, and it also has the highest population density (almost 70% of the total population), as well as industry and nightclubs.
The researcher points out that this “indicates, with increasing likelihood, that drugs are reaching the sewer and channel systems, and that in many cases they could be affecting the irrigation channels and waters of the L’Albufera lake”.
The team also found very high levels in some particular samples taken in the area of Benifaió and Almusaffes, which can only be explained by the presence of untreated waste water.
A risk for the wetlands
Exhaustive eco-toxocological studies into the risk the presence of these substances in the water could pose to people and the environment have not yet been carried out. However, the scientists have issued a warning about the possible consequences.
“The health problems potentially caused by consuming these, added to the fact that these residues are still strongly pharmacologically active, may have consequences for land organisms and aquatic fauna”, said Picó.
The L’Albufera Natural Park is one of the most important wetlands in Europe because of its biodiversity of flora and fauna, and because it is a key area for migratory birds. The area is a SPAB (Special Protection Area for Birds), is on the List of Sites of Community Importance for the Mediterranean Biogeographical Region, and is covered by the RAMSAR Convention on Wetlands.
Paradoxically, the park is surrounded by cities, industries, farms, shopping malls and leisure centres. The wetland is bordered by the Mediterranean highway and the V-31 motorway, and crossed by the Saler motorway and other roads. The L’Albufera is also affected by pressure from the 12 urban centres – including the city of Valencia – and the 14 municipal districts that surround it.
Public release date: 22-Sep-2010
Chromium picolinate may lessen inflammation in diabetic nephropathy
Supplement linked to decreased protein in the urine of diabetic mice
Bethesda, Md. (September 22, 2010) – Taking chromium picolinate may help lessen inflammation associated with diabetic nephropathy (kidney disease), say researchersat the Medical College of Georgia in Augusta. In a study comparing diabetic mice treated with chromium picolinate with those that received placebo, the researchers found that mice who received the supplement had lower levels of albuminuria (protein in the urine), an indication of kidney disease.
To arrive at their conclusions, the researchers compared three groups of mice, one lean, healthy group and two groups genetically engineered to be obese and have diabetes. When the mice were 6 weeks old, the researchers separated them according to treatment plan. The healthy mice and one group of diabetic mice, the untreated diabetic group, were fed a regular rodent diet. The remaining group, the treated diabetic group, were fed a diet
enriched with chromium picolinate.
Over the course of 6 months, the researchers measured glycemic control and albuminuria in all three groups. The untreated diabetic mice excreted nearly 10 times more albumin than the db/m mice, which was to be expected. However, the treated diabetic mice, who were fed the diet with chromium picolinate, excreted about half as much albumin compared to their untreated diabetic counterparts.
At the end of 6 months, the mice were euthanized and the researchers studied tissue samples from the mice’s kidneys. They found that the untreated diabetic mice had marked immunostaining for interleukin 6 (IL-6) and interleukin 17 (IL-17), two cytokines associated with inflammation. These mice also had moderate immunostaining for indolamine 2,3-dioxygenase (IDO), an immunoregulatory enzyme that modulates the production of IL-6 and IL-17. However, the treated diabetic mice had intense immunostaining for IDO but reduced IL-6 and IL-17 compared to the untreated diabetic group. The implication is that the chromium picolinate may have reduced inflammation in the treated diabetic group by affecting IDO, IL-6, and IL-7.
Mahmood Mozaffari, DMD, PhD, professor in the Medical College of Georgia Department of Oral Biology and lead author of the study, noted that the results are preliminary and that further studies are necessary to tease out the effects of chromium picolinate. He is particularly interested in the relationship between IDO and chromium picolinate because IDO is involved in the metabolism of tryptophan, an amino acid, and one of the by-products of that metabolism is picolinic acid.
“This clearly raises an important question for us as to whether our observations are related to the provision of picolinic acid from the chromium picolinate or whether the formulation [chromium picolinate], in and of itself, is mediating the effects.”
Public release date: 22-Sep-2010
Study: Doctors overprescribe antibiotics for respiratory infections
Doctors frequently misuse antibiotics when treating patients hospitalized with respiratory tract infections (RTIs), according to a study to be published in the November issue of Infection Control and Hospital Epidemiology.
The study, which tracked patients in two Pennsylvania hospitals, found that doctors often use antibiotics to treat patients whose infections are known to be caused by viruses. The findings are alarming because antibiotics are not effective against viruses, and antibiotic overuse has been linked to the development of resistant bacterial strains.
“[T]hese data demonstrate at least one area where antibiotics are commonly used in hospitalized patients without clear reason,” write the study’s authors, Kevin T. Shiley, Ebbing Lautenbach and Ingi Lee, all from the University of Pennsylvania School of Medicine. “Recognition of this may be helpful in developing interventions to limit inappropriate antibiotic use in the future.”
In recent years, new diagnostic tests have been developed to distinguish infections caused by viruses from those caused by bacteria. In theory, more definitive diagnoses should reduce the inappropriate use of
antibiotics in patients with viral infections. But that does not appear to be happening, according to Shiley and his colleagues.
The researchers looked at data on RTI patients admitted to two hospitals over a two-year period. Of 196 patients who were diagnosed with viral infections, 125 remained on antibiotics after their diagnoses. It would be understandable to keep a patient on antibiotics if an abnormal chest x-ray suggests a concurrent bacterial infection, the researchers said. However, only 37% of these patients had abnormal chest x-rays. “It is less clear why the remaining 63% of patients with normal chest imaging were prescribed antibiotics,” Shiley and his colleagues write.
NO CLINICAL BENEFIT
Patients in the study who remained on antibiotics did not benefit from the treatment, the researchers found. In fact, antibiotics may have led to harm in some cases. For example, a significant number of antibiotic patients developed Clostridium difficile diarrhea, a condition linked with antibiotic use.
On average, the antibiotic group had longer hospital stays and higher mortality rates than the non-antibiotic group. While those poorer outcomes cannot be attributed directly toantibiotic treatment, they do suggest that there was no clinical benefit, the researchers say.
“This study highlights the crucial role of antimicrobial stewardship in improving patient care,” said Neil O. Fishman, M.D. at the University of Pennsylvania and president of the Society for Healthcare Epidemiology of America. “Appropriate use of antibiotics is not only essential to limiting emergence of resistance, but also may help improve clinical outcomes.”
Public release date: 23-Sep-2010
Declining breast cancer incidence in Canada with declining HRT usage
Breast cancer incidence declined among postmenopausal women in Canada as their use of hormone therapy declined, according to a study published online September 23 in The Journal of the National Cancer Institute.
The Women’s Health Initiative (WHI) trial of more than 16,000 postmenopausal women in the United States reported in 2002 that the risks of combined estrogen and progestin hormone replacement therapy outweighed the benefits. As a result, prescriptions for hormone therapy fell dramatically in several countries around the world and so did the incidence of breast cancer.
To determine whether a similar decline of hormone therapy use and breast cancer incidence occurred in Canada, Prithwish De, Ph.D., of the Canadian Cancer Society, and colleagues, analyzed data from various Canadian registries and from a national health survey for women aged 50-69 years. Specifically, the researchers looked at information on prescriptions for hormone replacement therapy, breast cancer incidence, mammography rates, and self-reported use of hormone replacement therapy.
The researchers found that “the nearly 10% drop in invasive breast cancer rates coincided with the decline in use of hormone replacement therapy reported among Canadian women aged 50-69 years.” The steepest decline in use occurred between 2002 and 2004, when use dropped from 12.7% to 4.9%. In that same period, breast cancer incidence dropped 9.6% but mammography rates remained stable.
The researchers write that the decline in breast cancer incidence “is likely explained by the concurrent decline in the use of hormone replacement therapy among Canadian women.” They also say the drop in hormone therapy use may be partly explained by the media’s coverage of results of both the WHI and the Million Women Study in the U.K., both of which showed that breast cancer risk was elevated with the use of combined hormone therapy. In Canada, cancer rates began to increase again in 2005 among women aged 50-69 years, which might be further evidence of a link between hormone therapy and breast cancer,
according to the authors.
“Such a rebound might be expected if occult hormone-sensitive tumors were merely slowed by the withdrawal of hormone replacement therapy rather than prevented by it. If so, hormone replacement therapy may be thought to act as a promoter, rather than a cause of breast cancer,” they write.
The study’s limitations include the fact that data on hormone replacement therapy use was self-reported— and therefore subject to recall bias—and that data on frequency or duration of use were not collected. Also, data on receptor status of breast tumors were not collected.
In conclusion, the authors write that “further long-term surveillance studies of trends between hormone replacement therapy and breast cancer incidence can help reconcile the potential population-level associations of these two factors.”
Public release date: 23-Sep-2010
Vitamin C rapidly improves emotional state of acutely hospitalized patients, say LDI researchers
Simple treatment may counteract widespread problem of subnormal vitamin levels in acute-care patients
Treatment with vitamin C rapidly improves the emotional state of acutely hospitalized patients, according to a study carried out by researchers at Montreal’s Jewish General Hospital (JGH) and the affiliated Lady Davis Institute for Medical Research (LDI).
In a double-blind clinical trial, patients admitted to the JGH were randomly assigned to receive either vitamin C or vitamin D supplements for seven to ten days. Patients administered vitamin C had a rapid and statistically and clinically significant improvement in mood state, but no significant change in mood occurred with vitamin D, the researchers discovered. Their results were published recently in the journal Nutrition.
“Earlier studies, both in our hospital and in other centres, demonstrated that the majority of acutely hospitalized patients have subnormal levels of vitamins C and D in their blood,” said Dr. L. John Hoffer, MD, PhD, an investigator at the Lady Davis Institute for Medical Research.
“About one in five acute-care patients in our hospital have vitamin C levels so low as to be compatible with scurvy,” added Hoffer, also a Senior Physician
in the Divisions of Internal Medicine and Endocrinology, and a professor of medicine at McGill University. “But patients are rarely given vitamin supplements. Most physicians are simply unaware of the problem. Subclinical deficiencies of vitamin C and D have each been linked to psychological abnormalities, sowe examined that aspect in our clinical trial.”
“The lack of any effect of vitamin D on mood is good evidence we are not dealing with a placebo response,” said Dr. Hoffer. “This looks like a true biological effect. Our finding definitely requires follow up in larger studies in other centres,” he said. “The treatment is safe, simple and cheap, and could have major clinical practice implications.”
Public release date: 23-Sep-2010
Why the EU banned Avandia but the FDA didn’t
FORTUNE — Avandia has taken some beatings over the years, but it pretty much took a fatal blow yesterday. That’s when the Food and Drug Administration ruled to keep the drug on the market in the United States with some serious restrictions.
Those being: GlaxoSmithKline (GSK), the drug’s manufacturer, can’t promote it. Patients currently on the drug will be advised to switch to another similar treatment, if possible. Doctors can’t prescribe Avandia to new patients without explaining in detail why it might be more likely to cause a heart attack than other options. The FDA basically mandated everything short of putting a skull and crossbones on the label. But here’s the rub: The European Union’s European Medicines Agency dispensed with the subtleties and outright banned Avandia from being sold. Why didn’t the FDA?
There are some clues in parsing the FDA statement: Mainly, it seem like the regulator is in a Catch-22. Studies on the safety of Avandia, or rosiglitazone, relative to the only other drug in its class called Actos, or pioglitazone, have been problematic. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research and the author of the official FDA statement, put it this way:
“The existing data from observational studies comparing rosiglitazone to pioglitazone suggest that pioglitazone use may be associated with better cardiovascular outcomes. However, it is difficult to draw definite conclusions from these studies, both because of the small size of the observed effects, and because it is not clear whether the findings, if valid, represent beneficial effects of pioglitazone or toxicities of rosiglitazone.”
Translation: The FDA claims that because the findings of the study, which might not be valid, were hard to interpret, there isn’t enough data to kill the drug, which, after all, it once approved for sale. But now that the FDA knows Avandia is dangerous, it can’t order more studies to gather the evidence needed to kill it. So the FDA maimed it instead.
The reasoning behind Avandia’s U.S. stay of execution
The FDA also says it wants to keep Avandia on the market because patients already taking it might not want to switch drugs mid-regimen. The other reason is that some patients might benefit from regulating their blood sugar with that class of drug, and be unable to tolerate Actos. Given the extensive safety warnings tacked onto Avandia now, anyone else who takes it would have to (or as the FDA believes, may have no choice but to) play Russian roulette with their meds.
For the EU, the sheer risks of the drug outweigh the benefits. Lawsuits against GSK allege that tens of thousands of heart attacks and deaths stem from use of Avandia. That may be why the EMA banned the drug outright, and required that it be pulled from the market.
The one-two punch from the FDA and EMA are probably the last of a long series of image and revenue-crippling blows to Avandia. The first came in 2007, when Dr. Steven Nissan and his colleague sorted through a study conducted by GSK on Avandia’s safety, and found that the drug significantly increased a patient’s risk for heart disease. Then the FDA called an advisory panel to review Avandia, which ruled that it should stay on the market, albeit with dramatic labeling changes.
New evidence surfaced in 2009 that suggested GSK hid important information about the drug’s safety from officials. The FDA called in an advisory panel of 33 experts thissummer. Twenty-one of the experts voted to keep the drug on the market, but only with a plan of action that would most likely limit sales of the drug. In industry-speak, such plans of action are called Risk Evaluation and Mitigation Strategies, or REMS. Yesterday is when the panel’s ruling came out, and the FDA acted as advised.
FDA not much for banning
That the FDA didn’t ban Avandia isn’t surprising. Once a drug is on the market, the FDA requires airtight evidence that it is killing people before pulling the trigger. Wyeth’s diet drug Fen-Phen stayed on the market for almost 30 years until the FDA reviewed reports from independent physicians, and found that the drug was causing abnormal heart activity in almost a third of the people taking it.
In another case, the attention deficit hyperactivity disorder drug Cylert stayed on the U.S. market for longer than Phen Fen. In 1995, a study showed that the drug caused a dangerous rate of liver failure in patients. Cylert was pulled in the UK immediately, but was available here for ten more years.
The EMA has a track record of pulling dangerous-looking drugs faster than the FDA. Thus, Avandia lives on in these United States as a zombie shell of its former top blockbuster self. Whether due to freedom to choose, a broken regulatory system, regulatory capture, or a revolving door between industry and government, the FDA does not often ban drugs. Even Vioxx, which the FDA esimates killed nearly 28,000 people, was voluntary pulled by Merck in 2004, with a strong shove, but no mandate from the regulator.
In two years, when GSK loses its patent for Avandia, and the drug goes generic, diabetes patients will presumably maintain the right to order the brand name or generic alternative once they have jumped through the FDA’s hoops to prove they “need” Avandia. However, they won’t be able to order generic Avandia — or any generic drug — even more cheaply, from Canada. That’s because cheaper generic drugs made “overseas” are a major target of banning by the FDA, due to legitimate concerns about patient safety. Yet, as Avandia, Vioxx and other drugs have shown, the name brand can often be just as dangerous.
Public release date: 23-Sep-2010
Amgen recalls anemia drugs due to glass flakes
By LINDA A. JOHNSON, AP Health Writer Linda A. Johnson, Ap Health Writer Fri Sep 24, 4:35 pm ET
TRENTON, N.J. – Amgen Inc. is recalling some lots of its blockbuster Epogen and Procrit anemia treatments because the injected drugs may contain glass flakes that could cause blood clots, swelling of veins, immune system reactions and other problems.
The Thousand Oaks, Calif., biotechnology company says the flakes are barely visible in most cases, and they have fielded no complaints or reports about problems that can be directly tied to them. Patients experiencing problems should contact their doctor.
Amgen says the flakes are caused by the interaction of the drug with glass vials over the product’s shelf life.
The affected lot numbers and expiration dates can be found on websites for the products, and patients can call 1-800-77-AMGEN to ask questions. Patients harmed by the recalled products, or their doctors, should notify the Food and Drug Administration and either Amgen or Johnson & Johnson’s Centocor subsidiary.
This is not the first recall this year over a liquid medicine containing glass particles.
Baxter International announced a recall on May 17 for its genetically engineered Hylenex, a solution for rehydrating sick children. Baxter officials also said bits of glass had peeled off the inside of vials.
Epogen treats anemia in patients with chronic renal failure who are on dialysis. Procrit also treats it for cancer patients on chemotherapy and some HIV-infected patients.
Amgen makes both products at plants in Puerto Rico. It has long had a deal under which Johnson & Johnson sells Procrit in the U.S. The drugs work by stimulating production of oxygen-carrying red blood cells, which reduces anemia and can decrease the need for blood transfusions.
Sales of the products have declined somewhat in recent years because of restrictions by the U.S. Centers for Medicare and Medicaid Services over concerns that higher doses of the drugs can be dangerous. Research has shown the medicines are linked to increased risk of death, heart attack, stroke, life-threatening blood clots and growth of tumors in cancer patients.
Ralph’s Note – The glass flakes are barely visible. Is that supposed to make us feel better?
These reports are done with the appreciation of all the Doctors, Scientist, and other Medical Researchers who sacrificed their time and effort. In order to give people the ability to empower themselves. Without the base aspirations for fame, or fortune. Just honorable people, doing honorable things.
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