Rates of nausea and vomiting in pregnancy and dietary characteristics across populations Gillian V. Pepper and S. Craig Roberts Abstract: Nausea and vomiting in pregnancy (NVP) is a pervasive and debilitating phenomenon in humans. Several adaptive explanations for NVP occurrence have been recently proposed, the two most prominent of which predict associations with nutritional intake or specific dietary components. Here we extend previous cross-cultural analyses by analysing associations between NVP prevalence in 56 studies (21 countries) and quantitative estimates of per capita intake across major dietary categories, measured for the year of study by the Food and Agriculture Organisation (FAO). Rates of nausea and vomiting in pregnancy were correlated with high intake of macronutrients (kilocalories, protein, fat, carbohydrate), as well as sugars, stimulants, meat, milk and eggs, and with low intake of cereals and pulses. Restricting analyses to studies from North America and Europe caused relationships between macronutrient intake and NVP to disappear, suggesting that they might be influenced by non-dietary confounds associated with geographical region of study. However, factor analysis of dietary components revealed one factor significantly associated with NVP rate, which was characterized by low cereal consumption and high intake of sugars, oilcrops, alcohol and meat. The results provide further evidence for an association between diet and NVP prevalence across populations, and support for the idea that NVP serves an adaptive prophylactic function against potentially harmful foodstuffs. Gillian V. Pepper (AFF1) and S. Craig Roberts (AFF1) AFF1 School of Biological Sciences, University of Liverpool, Crown Street, Liverpool L69 7ZB, UK ISSN: 0962-8452 (Paper) 1471-2954 (Online) Issue: FirstCite Early Online Publishing DOI: 10.1098/rspb.2006.3633

Norwalk, Iowa—The March 2006 issue of the Clinical Journal of Pain contains a systematic review of manual therapies research for the treatment of tension-type headache (TTH). After review of clinical and randomized controlled trials, published in English since 1994 and listed in MEDLINE, EMBASE, AMED, MANTIS, CINAHL, PEDro, and Cochrane databases, the researchers concluded that there is “no rigorous evidence that manual therapies have a positive effect in the evolution of TTH.” While these results are alarming, Anthony L. Rosner, Ph.D., LLD (Hon), Director of Research for the Foundation for Chiropractic Education and Research, admits that “regarding spinal manipulation, the most important aspect to carry away from this paper is that as a specific modality it may yet lack definitive supporting evidence in the management of tension-type headache.” The same is not true for cervicogenic headache (which this current study did not examine). For cervicogenic headache, there is high-quality evidence which suggests benefits specifically attributed to spinal manipulation. Dr. Rosner adds that “of all the healthcare providers able to distinguish between the types of headaches with an accurate diagnosis and then apply an appropriate therapy, it would appear that chiropractors more than any of the other alternatives are the best equipped to do so.” Even so, the chiropractic community must be aware that key areas of research are glaringly absent for the headaches and other conditions which they see on a regular basis. Such topics as the effects of the specific technique applied or its frequency and distribution over time are only now beginning to be addressed—and there is a long way to go. Outcome studies for pediatric headaches have yet to be published. The only way in which chiropractic is going to gain validation and reimbursement in these areas is through research, and it is through the support of FCER and its awarding of grants to deserving investigators within the chiropractic field that this goal can best be met. In the last 20 years alone, FCER—with the help of substantial financial input from NCMIC Insurance Company—has funded over $10 million in chiropractic research. Though every practicing D.C. has anecdotal, practice-based evidence supporting chiropractic efficacy for numerous conditions, that evidence will never be incorporated into systematic reviews. Quality published research is the only way that chiropractic will gain the respect it deserves in scientific circles. Please help chiropractic gain that respect today—join FCER. For more information on FCER, please go to www.fcer.org. FCER is a 501(c)(3) non-profit organization.

The Food and Drug Administration (FDA) announced the strengthening of its efforts against unapproved drug products. The activity will begin with prescription products containing the antihistamine carbinoxamine because of safety concerns regarding their use in children under 2 years of age. The agency is issuing a final guidance document outlining its approach to addressing other medicines that are marketed without FDA approval. The first action under the new guidance, "Marketed Unapproved Drugs--Compliance Policy Guide," concerns carbinoxamine-containing products. Carbinoxamine-containing products require FDA approval to be marketed, but numerous products containing carbinoxamine, either alone or in combination with other active ingredients, are marketed without FDA approval. To date, FDA has approved two carbinoxamine products for various allergic symptoms. Many unapproved carbinoxamine products are labeled for treatment of cough and cold symptoms, an indication for which carbinoxamine has not been found safe and effective by FDA. Many companies are selling carbinoxamine drops and syrups that are specifically labeled for use in children as young as one month of age. Carbinoxamine has never been studied in very young children, and FDA cannot predict how they will respond to it. However, children under 2 years of age are more susceptible to drug-related adverse events, in part due to the immaturity of their systems. FDA estimates that there are several hundred different unapproved active ingredients in prescription drugs on the market. The agency estimates that less than 2 percent of prescribed drugs are unapproved. "Right now, many unapproved drugs represent a public health threat because consumers wrongly assume that these widely marketed and available drugs are approved and have been found to be safe and effective by the FDA," said Acting FDA Commissioner Dr. Andrew von Eschenbach. "While we want to ensure continued patient access to necessary treatments, as a physician I feel strongly that patients expect and deserve all their prescription medicines to be FDA approved. These unapproved drugs have bypassed the agency approval process through which FDA ensures, based on reliable scientific data, that marketed drugs are safe, effective, properly manufactured, and accurately labeled." Many of the unapproved drugs affected by today's final guidance, including the antihistamine carbinoxamine, are medicines that were developed and marketed before successive changes to the drug approval process that is established in the Federal Food, Drug, and Cosmetic Act. FDA approval guarantees that a product has been reviewed and will be consistently monitored for safety, effectiveness and adherence with manufacturing quality standards. "Unapproved drugs may not meet modern standards for safety, effectiveness, quality, and labeling. Clearly this is a problem we intend to fix," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. Health care providers are often unaware of the unapproved status of some drugs and have continued to unknowingly prescribe unapproved drugs because the drugs' labels do not disclose that they lack FDA approval. Often these drugs are advertised in reputable medical journals or are included in widely used pharmaceutical references such as the Physicians' Desk Reference (PDR). Under the guidance issued today, FDA is encouraging companies to comply with the drug approval process and seek approval for their products, as well as safeguarding consumer access to important medicines. The guidance identifies as the highest priority for agency enforcement action those unapproved products that are most likely to pose a risk to public health. The guidance explains that FDA intends to continue to give priority to enforcement actions involving unapproved drugs (1) with potential safety risks, (2) that lack evidence of effectiveness, and (3) that constitute health fraud. It also explains how the agency intends to address those situations in which a company obtains FDA approval to sell a drug that other companies have long been selling without FDA approval. Those manufacturers that do not comply with drug approval requirements may be subject to enforcement action. Today's actions are part of FDA's broader initiative, launched last year, to ensure that consumers and the health care community are provided with established and emerging drug safety information so that they can make the best possible medical decisions about the safe and effective use of drugs. The agency is committed to working with companies to facilitate the process of ensuring that products are safe and effective and meet appropriate standards for manufacturing and labeling. It is noted that some unapproved drugs may provide benefits. However, since these unapproved drugs are not approved by the FDA, the agency recommends that patients and health care professionals carefully consider the medical condition being treated, the patient's previous response to the drug, and the availability of approved alternatives for treatment.

Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials Patricia M Kearney, Colin BaigentJon Godwin, Heather Halls, Jonathan R Emberson, Carlo Patrono Abstract Objective To assess the effects of selective cyclo-oxygenase-2 (COX 2) inhibitors and traditional non-steroidal anti-inflammatory drugs (NSAIDs) on the risk of vascular events. Design Meta-analysis of published and unpublished tabular data from randomised trials, with indirect estimation of the effects of traditional NSAIDs. Data sources Medline and Embase (January 1966 to April 2005); Food and Drug Administration records; and data on file from Novartis, Pfizer, and Merck. Review methods Eligible studies were randomised trials that included a comparison of a selective COX 2 inhibitor versus placebo or a selective COX 2 inhibitor versus a traditional NSAID, of at least four weeks' duration, with information on serious vascular events (defined as myocardial infarction, stroke, or vascular death). Individual investigators and manufacturers provided information on the number of patients randomised, numbers of vascular events, and the person time of follow-up for each randomised group. Results In placebo comparisons, allocation to a selective COX 2 inhibitor was associated with a 42% relative increase in the incidence of serious vascular events (1.2%/year v 0.9%/year; rate ratio 1.42, 95% confidence interval 1.13 to 1.78; P = 0.003), with no significant heterogeneity among the different selective COX 2 inhibitors. This was chiefly attributable to an increased risk of myocardial infarction (0.6%/year v 0.3%/year; 1.86, 1.33 to 2.59; P = 0.0003), with little apparent difference in other vascular outcomes. Among trials of at least one year's duration (mean 2.7 years), the rate ratio for vascular events was 1.45 (1.12 to 1.89; P = 0.005). Overall, the incidence of serious vascular events was similar between a selective COX 2 inhibitor and any traditional NSAID (1.0%/year v 0.9%/year; 1.16, 0.97 to 1.38; P = 0.1). However, statistical heterogeneity (P = 0.001) was found between trials of a selective COX 2 inhibitor versus naproxen (1.57, 1.21 to 2.03) and of a selective COX 2 inhibitor versus non-naproxen NSAIDs (0.88, 0.69 to 1.12). The summary rate ratio for vascular events, compared with placebo, was 0.92 (0.67 to 1.26) for naproxen, 1.51 (0.96 to 2.37) for ibuprofen, and 1.63 (1.12 to 2.37) for diclofenac. Conclusions Selective COX 2 inhibitors are associated with a moderate increase in the risk of vascular events, as are high dose regimens of ibuprofen and diclofenac, but high dose naproxen is not associated with such an excess. BMJ 2006;332:1302-1308 (3 June), doi:10.1136/bmj.332.7553.1302 Patricia M Kearney, clinical research fellow1, Colin Baigent, reader in clinical epidemiology1, Jon Godwin, research fellow1, Heather Halls, research assistant1, Jonathan R Emberson, senior statistician1, Carlo Patrono, professor of pharmacology2 1 Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford OX3 7LF, 2 Department of Pharmacology, University of Rome "La Sapienza," Rome, Italy

(Washington, D.C - May 11, 2006) In a historic victory for chiropractors and their patients, S.1955, the Health Insurance Marketplace Modernization and Affordability Act, was withdrawn from the Senate floor today and effectively defeated when Democrats threatened to filibuster the bill. The controversial small business health plan legislation spurred an unprecedented grassroots lobbying campaign by the American Chiropractic Association and hundreds of provider and consumer groups that believed the bill would gut state patient protection laws and leave millions of patients without crucial health care benefits. “The ACA extends an enormous ‘thank you’ to the entire chiropractic profession – state associations, individual doctors, patients, students, chiropractic college leaders and other organizations – everyone who joined together to successfully defeat this potentially devastating legislation,” said ACA President Richard Brassard, DC. “A special thank you also goes out to our allies in Congress – Senators Tom Harkin, Jeff Bingaman, Ted Kennedy, Harry Reid and others – for their outstanding leadership on this important issue. Not only did we safeguard the health coverage of millions of patients across the country, but we also showed the nation’s decision makers that the chiropractic profession is a force to be reckoned with. I can assure you that your thousands of emails, faxes and phone calls to Congress, letters and news releases to local media organizations, and other grassroots efforts made the difference.” Deliberations on S.1955 began Tuesday, when Senate Democrats, in a procedural move, voted to allow the bill to advance to the Senate floor -- with debate limited to 30 hours. On Thursday afternoon, after Senate Majority Leader Bill Frist announced that debate would end and limited amendments to S.1955 would be considered, Senate Democrats voted against cloture and the bill was pulled from consideration. The defeat of S.1955 comes after a nearly two- month-long grassroots lobbying campaign kicked off in March at the ACA’s 31st annual National Chiropractic Legislative Conference (NCLC) in Washington, DC. During that meeting, ACA’s House of Delegates declared a “state of emergency” in response to S.1955 and committed to using “all available resources” to defeat the bill. Chiropractors nationwide joined together in the effort and flooded U.S. Senate offices with concerns about the bill. At the same time, ACA and a diverse coalition of labor unions, health care and consumer groups – including AARP, the American Cancer Society, the American Diabetes Association and the AFL-CIO -- shared information and resources in a national lobbying and media relations campaign to defeat the legislation. “Today, we can breathe a great sigh of relief,” added Dr. Brassard, “but only for a moment. The small business or association health plan concept is a popular one, and a new bill will almost certainly surface again in the very near future. The ACA will work to ensure that the chiropractic profession has a place at the table when a new proposal is developed, and we will once again call the chiropractic profession to action when necessary to ensure the health and well being of our patients.”

ABSTRACT Background: Patient global ratings of care are commonly used to assess health care. However, the extent to which these assessments of care are related to the technical quality of care received is not well understood. Objective: To investigate the relationship between patient-reported global ratings of health care and the quality of providers' communication and technical quality of care. Design: Observational cohort study. Setting: 2 managed care organizations. Patients: Vulnerable older patients identified by brief interviews of a random sample of community-dwelling adults 65 years of age or older who received care in 2 managed care organizations during a 13-month period. Measurements: Survey questions from the second stage of the Consumer Assessment of Healthcare Providers and Systems program were used to determine patients' global rating of health care and provider communication. A set of 236 quality indicators, defined by the Assessing Care of Vulnerable Elders project, were used to measure technical quality of care given for 22 clinical conditions; 207 quality indicators were evaluated by using data from chart abstraction or patient interview. Results: Data on the global rating item, communication scale, and technical quality of care score were available for 236 vulnerable older patients. In a multivariate logistic regression model that included patient and clinical factors, better communication was associated with higher global ratings of health care. Technical quality of care was not significantly associated with the global rating of care. Limitations: Findings were limited to vulnerable elders who were enrolled in managed care organizations and may not be generalizable to other age groups or types of insurance coverage. Conclusions: Vulnerable elders' global ratings of care should not be used as a marker of technical quality of care. Assessments of quality of care should include both patient evaluations and independent assessments of technical quality. Annals 2 May 2006 | Volume 144 Issue 9 | Pages 665-672

Norwalk, Iowa — In the April 1, 2006 issue of the Journal of the Royal Society of Medicine, Ernst and Canter summarized 16 systematic reviews published between 2000 and May 2005 on the effectiveness of spinal manipulation. The Foundation for Chiropractic Education and Research (FCER) is always open to results of research if the research proves to be of good quality and lacking bias. The biases in this study are painfully apparent, rendering the sweepingly negative “findings” little more than the authors’ personal opinions. Ernst and Canter concluded that these data do not demonstrate that spinal manipulation is an effective intervention for any condition.” According to them, the data fail to demonstrate that spinal manipulation is effective for treating back pain, neck pain, dysmenorrhea, infantile colic, asthma, allergy, cervicogenic dizziness, and any medical complaint. The exception was for back pain, where spinal manipulation may be superior to sham manipulation but not to conventional interventions. Considering the possibility of adverse events associated with spinal manipulation, the authors determined that their review "does not suggest that spinal manipulation is a recommendable treatment." This study is so far from what would be considered a methodical and robust systematic review without bias as to render it highly suspect if not meaningless. Its methods of analyses have not been validated but rather reveal the authors' own carelessness — if not outright distortion — of the literature which it cites. Many of its glaring defects are ones that the authors attempt to criticize in other work. It fails to grasp how the hypotheses and methods of analysis in the reviews that it cites are bound to deliver differing conclusions, such that Ernst and Canter go out of their way to criticize the positive findings of a single chiropractic author while overlooking their own consistently negative findings for chiropractic which appear in no less than 25% of the reviews that they include in their discussion. Finally, the authors fail to recognize the major flaws in several of the primary sources of data which comprise the systematic reviews under scrutiny in this research. There are issues surrounding the Ernst and Canter review that substantially undercut any prompt and uncritical acceptance of its conclusions. These include (1) the failure of systematic reviews and meta-analyses to consider subgroups of patients receiving treatment, (2) the design flaws of a large number of the randomized controlled trials which comprised the systematic reviews addressed in this report, (3) the failure to consider that modern evidence-based medicine is based upon clinical observation as well as randomized clinical trials, (4) the failure to adequately address the relative risks of other treatments available in conventional medicine for the conditions discussed in this review, and (5) numerous revelations of bias of one of the authors (Ernst) which have been amply demonstrated and refuted elsewhere. Under these circumstances, Ernst and Canter's study can be greeted only with the most extreme skepticism. In lacking many of the elements required for a meaningful presentation of the evidence required for supporting treatment alternatives, this current report should not be considered worthy of guiding a clinical decision. As such, the glaring weaknesses of the report only serve to undermine the public's confidence in science as a means to inform health policy.