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A letter to the editor is presented in response to the article "Rethinking Clinical Trials" by A. Grove in the September 23, 2011 issue.

A response by Doctor Samuel Y. Sessions and Philip R. Lee to a letter to the editor discussing their article "Using tax reform to drive health care reform: putting the horse before the cart," published in a previous issue is presented.

At a U.S. Senate Hearing on ephedra alkaloids, acting the U.S. Food and Drug Administration commissioner Lester Crawford conceded that if these products were drugs, not dietary supplements, they would be off the market. But he also stated that unreasonable risk of harm at the recommended doses, is sufficient for withdrawal under the 1994 Dietary Supplements Health and Education Act (DSHEA), which allows marketing of naturally occurring products without requirements for safety or efficacy studies and is the legal standard for FDA withdrawal (2).In June 2001, the Canadian government warned Canadians not to use these products, and in January 2002, it announced a recall of “ephedra/ephedrine products with labelled or implied claims for appetite suppression, weight loss promotion, metabolic enhancement, increased exercise tolerance, body-building effects, euphoria, increased energy or wakefulness, or other stimulant effects”.

A response from Sidney M. Wolfe to a letter to the editor on the article "Direct-to-Consumer Marketing," which is about advertising and marketing of prescription drugs, in a previous issue.

The article discusses various issues related to direct-to-consumer advertising in medical care in the U.S. It is reported that, direct-to-consumer advertising has changed the nature of the doctor-patient relationship, the patients are now seeking much more medical information and are actively participating in decisions he affect their health. One benefit from such advertising is that, it increases patient's access to accurate, objective information about tests to diagnose and drugs to treat his illnesses. But, at the same time, confusion is said to arises when commercially motive promotional information is represented as educational. Several studies on direct-to-consumer advertising are also referred in the article.

A reply from the authors is presented in response to letters to the editor on the article "Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries," by P. Lurie and S. M. Wolfe, in the September 18, 1997.

The article discusses use of the antiretroviral drug zidovudine to reduce the chance of infection of human immunodeficiency virus (HIV) in infants born to HIV-positive women. After the results of the AIDS Clinical Trials Group (ACTG) Study 076 revealed the potential of zidovudine, the regimen was recommended for HIV-positive pregnant women who had not been exposed to zidovudine. The ACTG 076 regimen has not been widely used in Asia and Africa due to costs. The authors comment that a decision by the World Health Organization (WHO) to develop a less expensive regimen using placebo-controlled trials is unethical because it could allow many infants to be infected with HIV. Some researchers claims placebo-controlled trials are more efficient.

Presents a commentary on the advertising of pharmaceuticals. Research that misleading commercial sources about pharmaceuticals influence physicians more than scientific sources; The policing of drug advertising; What is needed for educating physicians for prescribing decisions; The advertising campaigns of William Douglas McAdams, Inc.

A letter to the editor is presented in response to the article on medical malpractice in the November-December 1987 issue of "Public Health Reports," by Robert E. Windom.

The article focuses on the discipline of physicians engaged in any criminal behavior in the U.S. The Federation of State Medical Boards, the association of state medical boards responsible for disciplining doctors, recommends that all state medical boards conduct criminal records checks as part of the licensure application process. Although criminal activity by physicians is of great concern both to the medical profession and the general public, state medical boards vary in their monitoring and discipline of criminal activities by licensed physicians.

The sale of ephedra-containing dietary supplements should be banned by the United States Food and Drug Administration (FDA). Many companies have responded to the adverse publicity about ephedra by introducing new "ephedra-free" supplements. By inappropriately classifying herbal medicines as dietary supplements, Dietary Supplement Health and Education Act (DSHEA) freed supplement manufacturers from requirements to provide evidence that their products are safe and effective and from the need to base health claims on sound scientific evidence. It is dangerous enough that the FDA lacks the legal authority to require evidence of safety and efficacy for dietary supplements, but a recent Harris Poll revealed the extent to which people are woefully unaware of the lack of such FDA requirements for marketing these products. The majority of people incorrectly thought that the FDA must approve dietary supplements before they are sold, that manufacturers are not allowed to make claims concerning safety unless supported by scientific evidence, and that the FDA requires label warnings about potential dangers. But, without a significant modification if not a repeal of the FDA-disabling 1994 Dietary Supplement Health and Education Act, more ephedrines and Bitter Oranges will surface, to the detriment of public health.

A response by Jonas Z. Hines to a letter to the editor about his article on the U.S. Food and Drug Administration's post hoc analysis.

Charles Natanson, Peter Lurie and Sidney M. Wolfe respond to a letter to the editor about their article "Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death: A Meta-Analysis" in a previous issue.

Objective: The adequacy of informed consent in the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) has been questioned. SUPPORT investigators and publishing editors, heads of government study funding agencies, and many ethicists have argued that informed consent was adequate because the two oxygen saturation target ranges studied fell within a range commonly recommended in guidelines. We sought to determine whether each oxygen target as studied in SUPPORT and four similar randomized controlled trials (RCTs) was consistent with usual care. Design/Participants/Setting: PubMed, EMBASE, Web of Science, and Scopus were searched for English articles back to 1990 providing information on usual care oxygen management in extremely premature infants. Data were extracted on intended and achieved oxygen saturation levels as determined by pulse oximetry. Twenty-two SUPPORT consent forms were examined for statements about oxygen interventions. Results: While the high oxygen saturation target range (91 to 95%) was consistent with usual care, the low range (85 to 89%) was not used outside of the SUPPORT trial according to surveys and clinical studies of usual care. During usual care, similar lower limits (< 88%) were universally paired with higher upper limits (≥ 92%) and providers skewed achieved oxygen saturations toward the upper-end of these intended ranges. Blinded targeting of a low narrow range resulted in significantly lower achieved oxygen saturations and a doubling of time spent below the lower limit of the intended range compared to usual care practices. The SUPPORT consent forms suggested that the low oxygen saturation arm was a widely practiced subset of usual care. Conclusions: SUPPORT does not exemplify comparative effectiveness research studying practices or therapies in common use. Descriptions of major differences between the interventions studied and commonly practiced usual care, as well as potential risks associated with these differences, are essential elements of adequate informed consent. [ABSTRACT FROM AUTHOR]

After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients' exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently. [ABSTRACT FROM AUTHOR]

The article reports on the result of the study on physicians' disciplinary information provided in Websites of state medical and osteopathic boards in the U.S. in 2006. It is stated that the Websites have featured hospital, state board and federal government actions, as well as malpractice judgments information. It provides various profiles of attending physicians for their customers direct accessibility.

Context: Hemoglobin-based blood substitutes (HBBSs) are infusible oxygen-carrying liquids that have long shelf lives, have no need for refrigeration or cross-matching, and are ideal for treating hemorrhagic shock in remote settings. Some trials of HBBSs during the last decade have reported increased risks without clinical benefit.Objective: To assess the safety of HBBSs in surgical, stroke, and trauma patients.Data Sources: PubMed, EMBASE, and Cochrane Library searches for articles using hemoglobin and blood substitutes from 1980 through March 25, 2008; reviews of Food and Drug Administration (FDA) advisory committee meeting materials; and Internet searches for company press releases.Study Selection: Randomized controlled trials including patients aged 19 years and older receiving HBBSs therapeutically. The database searches yielded 70 trials of which 13 met these criteria; in addition, data from 2 other trials were reported in 2 press releases, and additional data were included in 1 relevant FDA review.Data Extraction: Data on death and myocardial infarction (MI) as outcome variables.Results: Sixteen trials involving 5 different products and 3711 patients in varied patient populations were identified. A test for heterogeneity of the results of these trials was not significant for either mortality or MI (for both, I2 = 0%, P > or = .60), and data were combined using a fixed-effects model. Overall, there was a statistically significant increase in the risk of death (164 deaths in the HBBS-treated groups and 123 deaths in the control groups; relative risk [RR], 1.30; 95% confidence interval [CI], 1.05-1.61) and risk of MI (59 MIs in the HBBS-treated groups and 16 MIs in the control groups; RR, 2.71; 95% CI, 1.67-4.40) with these HBBSs. Subgroup analysis of these trials indicated the increased risk was not restricted to a particular HBBS or clinical indication.Conclusion: Based on the available data, use of HBBSs is associated with a significantly increased risk of death and MI. [ABSTRACT FROM AUTHOR]

Context: Recent legislation in 5 states and the District of Columbia mandated state disclosure of payments made to physicians by pharmaceutical companies. In 2 of these states, Vermont and Minnesota, payment disclosures are publicly available.Objectives: To determine the accessibility and quality of the data available in Vermont and Minnesota and to describe the prevalence and magnitude of disclosed payments.Design and Setting: Cross-sectional analysis of publicly available data from July 1, 2002, through June 30, 2004, in Vermont and from January 1, 2002, through December 31, 2004, in Minnesota.Main Outcome Measures: Accessibility and quality of disclosure data and the number, value, and type of payments of $100 or more to physicians.Results: Access to payment data required extensive negotiation with the Office of the Vermont Attorney General and manual photocopying of individual disclosure forms at Minnesota's State Board of Pharmacy. In Vermont, 61% of payments were not released to the public because pharmaceutical companies designated them as trade secrets and 75% of publicly disclosed payments were missing information necessary to identify the recipient. In Minnesota, 25% of companies reported in each of the 3 years. In Vermont, among 12,227 payments totaling $2.18 million publicly disclosed, there were 2416 payments of $100 or more to physicians; total, $1.01 million; median payment, $177 (range, $100-$20,000). In Minnesota, among 6946 payments totaling $30.96 million publicly disclosed, there were 6238 payments of $100 or more to physicians; total, $22.39 million; median payment, $1000 (range, $100-$922,239). Physician-specific analyses were possible only in Minnesota, identifying 2388 distinct physicians who received payment of $100 or more; median number of payments received, 1 (range, 1-88) and the median amount received, $1000 (range, $100-$1,178,203).Conclusions: The Vermont and Minnesota laws requiring disclosure of payments do not provide easy access to payment information for the public and are of limited quality once accessed. However, substantial numbers of payments of $100 or more were made to physicians by pharmaceutical companies. [ABSTRACT FROM AUTHOR]

The article presents a study of financial conflict disclosures at drug-related meetings of the U.S. Food and Drug Administration (FDA), which are to be guided by regulations established by the FDA in January 2002. The study sampled FDA Drug Advisory Committee meetings from 2001-2004. THe methods of the study are discussed in detail, and the results are analyzed thoroughly. The study concludes that no vote outcome would have been altered had those with financial conflicts of interest been excluded.