FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers. H2 receptor blockers are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and heartburn.

Drugs of concern include:

• AcipHex (rabeprazole sodium)
• Dexilant (dexlansoprazole)
• Nexium (esomeprazole magnesium)
• Omeprazole (omeprazole) Over-the-Counter (OTC)
• Prevacid (lansoprazole) and OTC Prevacid 24hr
• Prilosec (omeprazole)  and OTC
• Protonix (pantoprazole sodium)
• Vimovo (esomeprazole magnesium and naproxen)
• Zegerid (omeprazole and Sodium bicarbonate) and OTC

BACKGROUND: Proton pump inhibitors (PPIs) are marketed under various brand and generic drug names as prescription and over-the-counter (OTC) products. They work by reducing the amount of acid in the stomach. Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter PPIs are used to treat frequent heartburn.

Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea that does not improve. Symptoms include watery stool, abdominal pain, and fever, and patients may go on to develop more serious intestinal conditions. The disease can also be spread in hospitals.

RECOMMENDATION: Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve. Information for Healthcare Professionals:

• A diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve.
• Advise patients to seek immediate care from a healthcare professional if they experience watery stool that does not go away, abdominal pain, and fever while taking PPIs.
• Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

It is good that the FDA MedWatch system is in operation as it can respond to situations such as this one. How much better would it be however, if we were not always shutting the gate after the horse had bolted? Remember that this system is nothing more than an elaborate drug trial where unsuspecting consumers are effectively used as “lab rats.” This recent finding of a link between manipulated gastric acid levels and a bacterial infection is just one of the several problems associated with this line of treatment. These drugs are seriously over used anyway so let us hope some people will be motivated to seek more appropriate treatment.

This is the first national study to evaluate the vitamin D status of Australians. Those at greatest risk for deficiency were women, the elderly, the obese, people doing less than 2.5 hours of physical activity a week, and people of non- European background.

The results highlight vitamin D deficiency as a major public health issue for Australia that requires urgent attention, said study leader Professor Robin Daly, Chair of Exercise and Ageing within the Centre for Physical Activity and Nutrition Research at Deakin University, and honorary fellow in the Department of Medicine (Northwest Academic Centre) at the University of Melbourne.

“Vitamin D deficiency is emerging as a major health problem worldwide. It is clear from the results of our study that, despite an abundance of vitamin D rich sunlight, Australians are not immune from this issue,” he said.

“Low levels of vitamin D can contribute to a number of serious, potentially life-threatening, conditions such as softened bones; diseases that cause progressive muscle weakness leading to an increased risk of falls, osteoporosis, cardiovascular disease, certain types of cancer and type 2 diabetes.

“While it was reassuring that only four per cent of the population had severely deficient levels, national strategies are urgently needed to attack the high prevalence of vitamin D deficiency in Australia before the problem worsens.”

For the study, the researchers measured the vitamin D levels of 11,218 adults aged 25-95 years from all six states and the Northern Territory as part of the Australian Diabetes, Obesity and Lifestyle (AusDiab) study conducted by the Baker IDI Heart and Diabetes Institute in 1999-2000.

The study revealed:

• 31 per cent of the population were vitamin D deficient
• Nearly three quarters (73 per cent) had levels considered by many experts as below the optimal for musculoskeletal health
• The prevalence of vitamin D deficiency increased with age, especially in women; 26 per cent of women aged 25-34 years were deficient which increased to 57 per cent for those aged 75 years and over. This is an important finding as vitamin D deficiency is a key risk factor for falls and fractures in the elderly.
• People of non-European origin were 4-5 times more likely to be deficient
• Those who were obese and physically inactive were around twice as likely to be vitamin D deficient

The prevalence of deficiency was also found to vary markedly by season and location, with deficiency more common during winter and in people residing in the southern states of Australia.

“For example, 42 per cent of women and 27 per cent of men living in the southern states were deficient during summer-autumn, which increased to 58 per cent of women and 35 per cent of men during winter-spring. Even in the northern states 31 per cent of women and 15 per cent of men were vitamin D deficient during winter-spring,” Professor Daly said.

Professor Daly and his co-authors from the University of Melbourne and the Baker IDI Heart and Diabetes Institute said it was timely and appropriate to develop national strategies across the whole population and further awareness campaigns for balancing safe sun exposure and adequate vitamin D intake to ensure optimal vitamin D status year-round for all Australians.

The results are published in the journal Clinical Endocrinology.

Notes
In this study vitamin D levels in the blood (also referred to as serum 25-hydroxyvitamin D) of less than 50 nmol/L represent deficiency and values less than 75 nmol/L represent insufficient level. Levels below 25 nmol/L are considered as severe deficiency.

Ethnicity was categorised into ‘Europid’ and non-Europid based on country of birth. The majority of participants were categorised as Europids which included those born in Australia, Northern Europe, Canada, USA and New Zealand. Non-Eurpoids included those born in Southern Europe, Asia, the Middle East, India and Sri Lanka, Pacific Islands, Africa and South and Central America.

Source: Deakin University

According to the BMJ:

One in seven UK based scientists or doctors has witnessed colleagues intentionally altering or fabricating data during their research or for the purposes of publication, found a survey of more than 2700 researchers conducted by the BMJ.

The survey, which was emailed to 9036 academics and clinicians who had submitted articles to the BMJ or acted as peer reviewers for the journal (response rate 31%), found that 13% of these researchers admitted knowledge of colleagues “inappropriately adjusting, excluding, altering, or fabricating data” for the purpose of publication.

Aniket Tavare, ‘Scientific misconduct is worryingly prevalent in the UK, shows BMJ survey’ BMJ 2012;344:e377

Unfortunately, it appears that the BMJ, while criticising the quality of the research done by others that it publishes, failed to be sufficiently diligent in the design, execution and analysis of its own survey. Professor Sheila Bird, a biostatistician from Cambridge, appears to have had a field day in providing a critique (http://www.bmj.com/content/344/bmj.e377?tab=responses). Perhaps the designers thought that a truly well crafted survey tool might frighten potential respondents, as if to suggest that this is indeed a matter that will be taken seriously. Who can tell just what was in their minds? In any case surveys can be notoriously weak if not performed well. Perhaps indeed, the BMJ feared that a better survey might reveal even more damaging findings.

In the Editorials section of the BMJ published 4 January 2012 Fiona Godlee, BMJ Editor in Chief and Elizabeth Wager, Chair Committee on Publication Ethics, UK  said “Research misconduct can harm patients, distort the evidence base, misdirect research effort, waste funds, and damage public trust in science.” It is reassuring to see they have some sense of the gravity of daily reality. They go on to argue for the establishment of some “formal mechanisms for overseeing research integrity” but one might be forgiven for sounding a little cynical by replying “good luck with that.” I would suggest that the problems they are attempting to solve are far more fundamental than any form of monitoring can deal with.

In the meantime I continue to recommend intelligent, critical consumption of anything and everything. Only the ignorant, the foolish and the lazy accept the pontifications of “science” uncritically. It is disturbing to see so much modern clinical practice that is highly dubious or obviously unsafe that becomes “normal practice” because individuals have become afraid to think for themselves, instead scurrying to the comfort of the crowd, the mantle of “approval” and the dictates of various authorities.

The Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee recommend that all U.S. health-care personnel (HCP) be vaccinated annually against influenza. However, even among HCP who reported working at a facility where vaccination was required by their employer, only 98.1% were vaccinated.

According to an editorial note “when compared with those vaccinated, significantly lower percentages of unvaccinated HCP expressed the beliefs that getting vaccinated was worth the time and expense and that influenza vaccination can protect them and the persons around them from disease.”

One has to ask the question, if nearly 40% of health workers reject influenza vaccination and a significant number of those do not believe influenza vaccination to be effective, why should ordinary consumers take on the risks associated with vaccination?

Full details are available here: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6032a1.htm?s_cid=mm6032a1_e&source=govdelivery

This weekend, scientists from an American medical institution published a study that has practical implications for patients undergoing ACL (Anterior Cruciate Ligament) surgery.

The study, by a group in Utah, may have answered in part the long sought question of why some patients do well after knee surgery (quickly regain strength in their quadriceps) and some do not. Dr. Tyler Barker, of the Orthopedic Specialty Hospital in Murray, Utah, and his colleagues at the University of Utah (where I did a surgical internship back in 1976) discovered that vitamin D levels are associated with muscle strength recovery after knee surgery (anterior cruciate repair). Those with levels above 30 ng/ml recovered much better than those with levels below 30 ng/ml.

Tyler Barker, Thomas B. Martins, Harry R. Hill, Carl R. Kjeldsberg, Roy H. Trawick, Lindell K. Weaver, and Maret G. Traber Journal of Evidence-Based Complementary & Alternative Medicine. published 29 July 2011, 10.1177/2156587211413768

I found it somewhat disappointing that the authors refused to say that vitamin D deficiency should be treated before knee surgery. All they would say was that Americans should fund more studies before any action is taken. Of course this is neither practical or ethical, as physicians are (and always have been) obligated to act on what is known now — not on what may or may not be discovered in the future. Randomized trials of vitamin D supplemention need to be undertaken to discover what the optimum vitamin D level for knee surgery is. But such trials will take years, while orthopedists need to act, or not, now.

John J. Cannell, M.D.

Vitamin D Council