Health and Medical News and Resources

General interest items edited by Janice Flahiff

Drug regulators are protecting profits over patients, warn researchers

From a 10 May Science Daily article

ScienceDaily (May 10, 2011) — Medicines regulators are protecting drug company profits rather than the lives and welfare of patients by withholding unpublished trial data, argue researchers on the British Medical Journal website.

They call for full access to full trial reports (published and unpublished) to allow the true benefits and harms of treatments to be independently assessed by the scientific community.
Despite the existence of hundreds of thousands of clinical trials, doctors are unable to choose the best treatments for their patients because research results are being reported selectively, write Professor Peter Gøtzsche and Dr Anders Jørgensen from the Nordic Cochrane Centre in Denmark.
Selective reporting can have disastrous consequences. For example, Rofecoxib (Vioxx) has probably caused about 100,000 unnecessary heart attacks in the USA alone, while anti-arrhythmic drugs have probably caused the premature death of about 50,000 Americans each year in the 1980s…..

…Journal Reference:
P. C. Gotzsche, A. W. Jorgensen. Opening up data at the European Medicines Agency. BMJ, 2011; 342 (may10 1): d2686 DOI: 10.1136/bmj.d2686 [Links to the free full text of the article]


Click here to read the rest of the Science Daily article

May 11, 2011 Posted by | Consumer Health, Public Health | , , , , | Leave a comment

Health Educators, Foundations Announce Competencies And Action Strategies For Interprofessional Education

From the 12 May 2011 Medical News Today article

Two new reports released today by six national health professions associations and three private foundations recommend new competencies for interprofessional education in the health professions, and action strategies to implement them in institutions across the country. By establishing these competencies, the proponents believe our nation’s health care system can be transformed to provide collaborative, high-quality, and cost-effective care to better serve every patient.

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May 11, 2011 Posted by | Public Health | , , | Leave a comment

Safety of Probiotics Used to Reduce Risk and Prevent or Treat Disease

The US Agency for Healthcare Research and Quality has recently released a report on the safety of probiotics to prevent and treat diseases.

From their press release

Objectives: To catalog what is known about the safety of interventions containing LactobacillusBifidobacteriumSaccharomycesStreptococcusEnterococcus, and/or Bacillus strains used as probiotic agents in research to reduce the risk of, prevent, or treat disease.

Data Sources: We searched 12 electronic databases, references of included studies, and pertinent reviews for studies addressing the safety of probiotics from database inception to August 2010 without language restriction.

Review Methods: We identified intervention studies on probiotics that reported the presence or absence of adverse health outcomes in human participants, without restriction by study design, participant type, or clinical field. We investigated the quantity, quality, and nature of adverse events.

Results: The search identified 11,977 publications, of which 622 studies were included in the review. In 235 studies, only nonspecific safety statements were made (“well tolerated”); the remaining 387 studies reported the presence or absence of specific adverse events. Interventions and adverse events were poorly documented.

A number of case studies described fungemia and some bacteremia potentially associated with administered probiotic organisms. Controlled trials did not monitor routinely for such infections and primarily reported on gastrointestinal adverse events. Based on reported adverse events, randomized controlled trials (RCTs) showed no statistically significantly increased relative risk (RR) of the overall number of experienced adverse events (RR 1.00; 95% confidence interval [CI]: 0.93, 1.07, p=0.999); gastrointestinal; infections; or other adverse events, including serious adverse events (RR 1.06; 95% CI: 0.97, 1.16;p=0.201), associated with short-term probiotic use compared to control group participants; long-term effects are largely unknown. Existing studies primarily examined Lactobacillus alone or in combination with other genera, often Bifidobacterium.

Few studies directly compared the safety among different intervention or participant characteristics. Indirect comparisons indicated that effects of delivery vehicles (e.g., yogurt, dairy) should be investigated further. Case studies suggested that participants with compromised health are most likely to experience adverse events associated with probiotics. However, RCTs in medium-risk and critically ill participants did not report a statistically significantly increased risk of adverse events compared to control group participants.

Conclusions: There is a lack of assessment and systematic reporting of adverse events in probiotic intervention studies, and interventions are poorly documented. The available evidence in RCTs does not indicate an increased risk; however, rare adverse events are difficult to assess, and despite the substantial number of publications, the current literature is not well equipped to answer questions on the safety of probiotic interventions with confidence.


Download Report

Safety of Probiotics Used to Reduce Risk and Prevent or Treat Disease

Evidence-based Practice Center: RAND-Southern California
Topic Nominators: National Institutes of Health (NIH) Office of Dietary Supplements; NIH National Center for Complementary and Alternative Medicine; Food and Drug Administration, Center for Food Safety and Applied Nutrition

Current as of April 2011


May 11, 2011 Posted by | Consumer Health, Medical and Health Research News | | Leave a comment

   

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