FDA Urged To Protect Medical Devices Against Hacking.

Bloomberg News  (9/28, Robertson) reports, "Wireless medical devices are potentially vulnerable to being remotely controlled by hackers and should be tracked more closely," according to report  (pdf) released Thursday by the Government Accountability Office. The investigation into "electronic medical-device safety was initiated after computer-security researchers found dangerous vulnerabilities in insulin pumps." Democratic Reps. Anna Eshoo (CA), Edward Markey (MA) and Donna Edwards (MD) had "asked last year for the GAO report, which called on the Food and Drug Administration to oversee better identification and investigation of security problems in electronic medical equipment such as insulin pumps, pacemakers and defibrillators."

        The Hill  (9/28, Viebeck) "Healthwatch" blog adds that the three Representatives issued a statement Thursday, calling for the FDA to "scrutinize implantable medical devices more carefully. ... 'The demonstrated security risks require a renewed emphasis by the FDA and manufacturers to identify, evaluate and plug the potentially rare but serious security holes that exist in these devices,'" they wrote. Reps. Eshoo, Edwards and Edward urged the FDA to "create a plan to ensure information security risks are considered during device approval" and pressed the agency to "consult related government standards on hacking and computer security for guidance." And although the GAO report noted that "no incidents of medical-device hacking are known to have occurred outside the laboratory," the three House Members "said the threat should not be overlooked."

        The Minneapolis Star Tribune  (9/28, Walsh) says that in its report, the GAO said the when the FDA considers "devices' vulnerability to threats," the agency typically focuses "more on unintentional threats, such as MRI machines or electromagnetic energy in the environment." But the GAO emphasized that Federal regulators should "consider information security risks resulting from intentional threats when reviewing manufacturers' submissions for new devices."

        Modern Healthcare  (9/28, Daly, Subscription Publication) adds that the GAO report also "criticized the FDA's post-market surveillance efforts, which include an adverse-event reporting system"; the authors pointed out that because "information security in active implantable medical devices is a relatively new issue, those reporting might not understand the relevance of information security risks." Meanwhile, FDA officials said they "plan to re-examine their evaluations of software used in medical devices and add an assessment of 'information security risks.'" FDA spokesperson Michelle Bolek said the FDA "concurs with GAO that the agency continuously develop and implement new strategies designed to assist the agency in its medical device premarket review and post-market surveillance efforts relative to information security."

        The National Journal  (9/28, Smith, Subscription Publication) also covers the GAO report and the House Members' statements in its "Tech Daily Dose" blog.

Studies: Chronic CKD Strongly Associated With Risk Of Kidney Failure, Death.

HealthDay  (9/27, Preidt) reports, "Chronic kidney disease [CKD] is strongly associated with the risk of kidney failure and death, even in patients without high blood pressure or diabetes," according to two studies conducted by researchers at the Johns Hopkins Bloomberg School of Public Health and published online Sept. 24 in The Lancet. In one study, "researchers found that low kidney function and high urinary levels of the protein albumin were associated with all-cause and cardiovascular death and kidney failure in both patients with and without high blood pressure." The other study found that CKD "patients with diabetes had a higher risk of all-cause and cardiovascular death and kidney failure than those without diabetes, regardless of their levels of kidney function and urine protein."

FDA approves REMS to warn of birth defects.

Dow Jones Newswire (9/25, Dooren) reports that the Food and Drug Administration on Tuesday announced it has approved a Risk Evaluation and Mitigation Strategy system for organ-transplant drugs that contain mycophenolate, which is an immunosuppressive agent and can cause birth defects if taken during pregnancy. The agency said the Mycophenolate REMS, which includes a training guide for healthcare providers and a medication guide they can distribute to patients, will establish a registry in which pregnant women will be given the option to participate. The FDA noted that approximately, 20 percent of babies exposed to mycophenolate during their mothers' pregnancies were born with congenital malformations.

FDA approves REMS to warn of birth defects.

Dow Jones Newswire (9/25, Dooren) reports that the Food and Drug Administration on Tuesday announced it has approved a Risk Evaluation and Mitigation Strategy system for organ-transplant drugs that contain mycophenolate, which is an immunosuppressive agent and can cause birth defects if taken during pregnancy. The agency said the Mycophenolate REMS, which includes a training guide for healthcare providers and a medication guide they can distribute to patients, will establish a registry in which pregnant women will be given the option to participate. The FDA noted that approximately, 20 percent of babies exposed to mycophenolate during their mothers' pregnancies were born with congenital malformations.

Review: Limited evidence shows that daily cinnamon intake does not improve HbA1c, serum insulin, or postprandial glucose in diabetes mellitus.

ACP JournalWise Link

Leach MJ, Kumar S. Cinnamon for diabetes mellitus. Cochrane Database Syst Rev. 2012 Sep 12;9:CD007170. (Review)

PMID: 22972104      

BACKGROUND: Diabetes mellitus is a chronic metabolic disorder that is associated with an increased risk of cardiovascular disease, retinopathy, nephropathy, neuropathy, sexual dysfunction and periodontal disease. Improvements in glycaemic control may help to reduce the risk of these complications. Several animal studies show that cinnamon may be effective in improving glycaemic control. While these effects have been explored in humans also, findings from these studies have not yet been systematically reviewed.

OBJECTIVES: To evaluate the effects of cinnamon in patients with diabetes mellitus. SEARCH

METHODS: Pertinent randomised controlled trials were identified through AARP Ageline, AMED, AMI, BioMed Central gateway, CAM on PubMed, CINAHL, Dissertations Abstracts International, EMBASE, Health Source Nursing/Academic edition, International Pharmaceutical Abstracts, MEDLINE, Natural medicines comprehensive database, The Cochrane Library and TRIP database. Clinical trial registers and the reference lists of included trials were searched also (all up to January 2012). Content experts and manufacturers of cinnamon extracts were also contacted.

SELECTION CRITERIA: All randomised controlled trials comparing the effects of orally administered monopreparations of cinnamon (Cinnamomum spp.) to placebo, active medication or no treatment in persons with either type 1 or type 2 diabetes mellitus.

DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed risk of bias and trial quality, and extracted data. We contacted study authors for missing information.

MAIN RESULTS: Ten prospective, parallel-group design, randomised controlled trials, involving a total of 577 participants with type 1 and type 2 diabetes mellitus, were identified. Risk of bias was high or unclear in all but two trials, which were assessed as having moderate risk of bias. Risk of bias in some domains was high in 50% of trials. Oral monopreparations of cinnamon (predominantly Cinnamomum cassia) were administered at a mean dose of 2 g daily, for a period ranging from 4 to 16 weeks. The effect of cinnamon on fasting blood glucose level was inconclusive. No statistically significant difference in glycosylated haemoglobin A1c (HbA1c), serum insulin or postprandial glucose was found between cinnamon and control groups. There were insufficient data to pool results for insulin sensitivity. No trials reported health-related quality of life, morbidity, mortality or costs. Adverse reactions to oral cinnamon were infrequent and generally mild in nature.

AUTHORS' CONCLUSIONS: There is insufficient evidence to support the use of cinnamon for type 1 or type 2 diabetes mellitus. Further trials, which address the issues of allocation concealment and blinding, are now required. The inclusion of other important endpoints, such as health-related quality of life, diabetes complications and costs, is also needed.

Critically ill patients may benefit from probiotics, but evidence is weak

Patients with thrombocytosis in the setting of community-acquired pneumonia (CAP) are at higher risk of poor outcome, complicated pleural effusion and empyema than those with a normal platelet count, a study found.

Researchers searched databases, article reference lists, and personal files from 1980 to 2011. Their review included 23 randomized controlled trials that evaluated use of probiotics versus placebo in critically ill adults for outcomes including infections (primary) and mortality and length of stay (secondary). Subgroup analyses were performed to compare high and low doses of probiotics, different strains of probiotics, and methodological quality of studies. Results were published Sept. 12 in Critical Care Medicine.

The mean methodological score of all trials was 9.5 (range, 6 to 13) of a possible 14. Of the 23 trials, seven (30%) tested the viability of the probiotics used in the intervention.

Different probiotic therapies were used among the 23 included trials; eight used Lactobacillus plantarum and three used Lactobacillus rhamnosus strain GG.

In the 11 trials that reported infectious complications, pooled results show that probiotics were associated with a reduction in such complications (risk ratio [RR], 0.82; P=0.03). Pooled data from the seven trials reporting VAP data found a significant reduction in VAP rates associated with probiotics (RR, 0.75; P=0.03). Probiotics were associated with a non-significant trend toward reduced ICU mortality (RR, 0.80; P=0.16) but had no effect on hospital mortality or length of stay in the ICU or hospital. More dramatic treatment effects were seen in trials of lower methodological quality.

The findings in this analysis were "tempered by the presence of significant clinical and statistical heterogeneity and the lack of statistical precision in some analyses," the authors noted, and were further weakened by the fact that more dramatic results were found in the lower-quality trials. The results are, however, consistent with a 2009 review that suggested probiotics reduce VAP. Other than one study from 2010, this review didn't find an association between probiotic use and fewer cases of diarrhea, they noted, similar to many previous studies. The best type and dosage of probiotics also were not clear from this analysis, they wrote.

A separate meta-analysis of 13 trials, published in the Sept. 10 Chest, found that probiotics didn't significantly reduce hospital or ICU mortality or the duration of mechanical ventilation. Probiotics were, however, associated with lower incidence of ICU-acquired pneumonia and a shorter stay in the ICU.

Questcor Under Probe Over Corticotropin Marketing.

Dow Jones Newswire  (9/25, Chaudhuri) reports Anaheim, California-based Questcor Pharmaceuticals Inc. on Monday disclosed in an SEC filing that Federal regulators are investigating the marketing practices the firm uses to promote its primary revenue generator, HP Acthar Gel (corticotropin). This revelation comes just one week after Aetna dropped coverage for most uses the injectable drug, which has FDA approval as treatment for several disorders, including nephrotic syndrome, multiple sclerosis, and infantile seizures.

        The AP  (9/25) reports Aetna said earlier this month that it will "drop reimbursement for all uses except infantile spasms, but patients currently receiving Acthar gel will be covered so they can complete their treatment. Aetna has said it expects to further review its policy on Acthar next month." As for the promotional probe, analysts "say these investigations can take years to play out." According to Oppenheimer analyst Christopher Holterhoff, "sales may be hurt if the company has to change its marketing" methods.

        Reuters  (9/24, Venkatesan) adds that Questcor neither disclosed which agency was performing the probe nor provided details on what aspects of the firm's marketing practices were being investigated. However, Reuters notes that the investigation was likely prompted by a California investment company, which stated it was concerned about Questcor's promotional methods in July; and ThinkEquity analyst Jim Molloy said he believes that probe is related to incentive payments to physicians.

        According to Bloomberg News  (9/25, Lopatto), Questcor "said it intends to cooperate with the investigation and that the company doesn't plan further comment except for regulatory-compliant disclosures." The Orange County Business Journal  (9/25, Reed) also covers the story.