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Introduction Throughout history, people have attempted to influence others by offering money, goods or services. if such influencepeddling had not been so successful, it might have vanished long ago. however, following Darwinian principles, it has progressively evolved, becoming more prevalent, complicated, extremely successful and, too often, damaging to people who, unaware of influencepeddling schemes, become their victims.

Despite the strict prohibition against all forms of sexual relations between physicians and their patients, some physicians cross this bright line and abuse their patients sexually. The true extent of sexual abuse of patients by physicians in the U.S. health care system is unknown. An analysis of National Practitioner Data Bank reports of adverse disciplinary actions taken by state medical boards, peer-review sanctions by institutions, and malpractice payments shows that a very small number of physicians have faced "reportable" consequences for this unethical behavior. However, physician self-reported data suggest that the problem occurs at a higher rate. We discuss the factors that can explain why such sexual abuse of patients is a persistent problem in the U.S. health care system. We implore the medical community to begin a candid discussion of this problem and call for an explicit zero-tolerance standard against sexual abuse of patients by physicians. This standard must be coupled with regulatory, institutional, and cultural changes to realize its promise. We propose initial recommendations toward that end.

This Viewpoint suggests the US Food and Drug Administration (FDA) halt approval of new opioids until the agency adopts a more rigorous framework for opioid review, providing 2 examples of new opioids that were approved by the FDA but had high rates of abuse after entering the drug market.

Purpose: The Food and Drug Administration (FDA) permits investigators to withhold active interventions from human subjects randomly assigned to control groups in clinical trials. The scope of this practice in trials for life-threatening diseases is unknown. We assessed the frequency and characteristics of trials providing control group subjects with active interventions versus those providing only placebos to control group subjects in trials supporting FDA approvals of new drugs for nine life-threatening diseases. Materials and methods: We reviewed the FDA's database of approved drug products and identified all new approvals from 2006 to 2011 for drugs or biological products indicated for asthma, bipolar disorder, chronic obstructive pulmonary disease (COPD), diabetes mellitus, hypertension, osteoporosis, Parkinson's disease, partial seizures, and schizophrenia. Then, we identified all trials described in FDA medical review documents for these approvals and abstracted information on trial characteristics and the interventions provided to control group subjects. Results: Of 508 included trials, 201 (39.6%) were placebo-only-controlled, meaning subjects in at least one control group did not receive an active intervention, and 307 (60.4%) were active-controlled, meaning subjects in all control groups received an active intervention. The total recorded enrollments in control groups provided with placebos only and in control groups provided with active interventions were 19,361 and 93,093 subjects, respectively. The proportion of placebo-only-controlled trials varied across diseases (P < 0.001), ranging from 75.5% for COPD to 0% for partial seizures and osteoporosis. Placebo-only controls were used in 76.9% of trials for severe COPD, 56.4% of trials for severe hypertension, 43.8% of trials for moderate or severe persistent asthma, and 6.7% of trials for severely uncontrolled diabetes. Logistic regression analysis showed that longer trials were associated with lower odds of being placebo-only-controlled compared with shorter trials. Conclusion: Providing only placebos to control groups in trials for life-threatening diseases is a common practice, potentially entailing varying degrees of risk to subjects. Further research is warranted to assess the impact of this practice, particularly in trials of long duration and those involving subjects with severe disease.

AbstractObjectiveThe objective of this study was to examine nurse sexual‐misconduct–related reports in the National Practitioner Data Bank (NPDB) and to compare them with reports for other types of offenses.Design and PopulationWe analyzed NPDB’s reports of adverse state nursing board licensure actions and malpractice payments for all nurses from January 1, 2003, to June 30, 2016.ResultsOverall, 882 nurses had sexual‐misconduct–related reports. Most were aged 35–54 (63.2%), male (63.2%), and registered or advanced practice nurses (61.5%). The disciplinary actions noted in the 988 nurse sexual‐misconduct–related licensure reports were more frequently serious than those noted in the 207,023 reports for other offenses committed by nurses (90.8% vs. 74.8%, respectively; p < 0.001). Of the 33 nurses with sexual‐misconduct–related malpractice‐payment reports, 48.5% were not disciplined by any state board of nursing for these offenses. Three‐quarters of the victims in the 47 sexual‐misconduct–related malpractice‐payment reports were female, with “emotional injury only” reported as the severity of injury in 91.5% of these reports.ConclusionsVery few nurses have been reported to the NPDB due to sexual misconduct. We welcome a zero‐tolerance standard against sexual misconduct involving patients by all types of health care professionals, including nurses.

An editorial is presented which addresses the authors' claim that patients should have the right to know about payments made by accountable care organizations to physicians in America as of 2017, and it mentions physician payment arrangements involving health maintenance organizations (HMOs) in the country. The U.S. Patient Protection and Affordable Care Act and the nation's Medicare health insurance program are assessed, along with incentives in medicine.

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.

Little information exists on U.S. physicians who have been disciplined with licensure or restriction-of-clinical-privileges actions or have had malpractice payments because of sexual misconduct. Our objectives were to: (1) determine the number of these physicians and compare their age groups' distribution with that of the general U.S. physician population; (2) compare the type of disciplinary actions taken against these physicians with actions taken against physicians disciplined for other offenses; (3) compare the characteristics and type of injury among victims of these physicians with those of victims in reports for physicians with other offenses in malpractice-payment reports; and (4) determine the percentages of physicians with clinical-privileges or malpractice-payment reports due to sexual misconduct who were not disciplined by medical boards.We conducted a cross-sectional analysis of physician reports submitted to the National Practitioner Data Bank (NPDB) from January 1, 2003, through September 30, 2013. A total of 1039 physicians had ≥ 1 sexual-misconduct-related reports. The majority (75.6%) had only licensure reports, and 90.1% were 40 or older. For victims in malpractice-payment reports, 87.4% were female, and "emotional injury only" was the predominant type of injury. We found a higher percentage of serious licensure actions and clinical-privileges revocations in sexual-misconduct-related reports than in reports for other offenses (89.0% vs 68.1%, P = < .001, and 29.3% vs 18.8%, P = .002, respectively). Seventy percent of the physicians with a clinical-privileges or malpractice-payment report due to sexual misconduct were not disciplined by medical boards for this problem.A small number of physicians were reported to the NPDB because of sexual misconduct. It is concerning that a majority of the physicians with a clinical-privileges action or malpractice-payment report due to sexual misconduct were not disciplined by medical boards for this unethical behavior.

We analysed all journals from two Journal Citation Reports (JCR) categories: ‘Dentistry, Oral Surgery and Medicine’ and ‘Otorhinolaryngology’ published in 2018 for their policies on publishing facial photographs and actual practices of publishing these photographs in articles. We extracted the following data for each journal: JCR category, impact factor, volume, issue, instructions for authors regarding ethical issues, instructions for photograph deidentification, journals’ references to standard research and publishing policies, presence and type of published clinical images, separate informed consent for the publication of patient photograph and methods of deidentification. The sample included 103 journals, which published 568 articles with 1404 clinical images. Around a half of the journals (52%) had a policy on clinical images, however, the only predictor of having a journal policy on clinical images was reference in the policy to International Committee of Medical Journal Editors Recommendations (OR=3.00, 95% CI 1.26 to 7.14, p=0.013). Identifiable patient photographs were found in 13% (79/568) of the articles, constituting 9% (128/1404) of the total sample of images. Only 16% (13/79) of articles publishing recognisable patient facial images included a statement about consent for publication of the image. From the total sample of articles, 34% (27/79) contained deidentified but recognisable patient photographs and only 22% (6/27) of them had a statement about patient consent for photograph publication. The patients’ consent was more likely stated in the article in cases of recognisable facial images (OR=2.81, 95% CI 1.41 to 5.63, p=0.004). Journals publishing clinical research involving the face and neck region need to establish and enforce policies on publishing clinical images.

More is spent in the US on rosuvastatin than any other statin. Yet the evidence of its health benefits has always been weak and there is growing evidence of harmful side effects. Sidney Wolfe explains why he thinks the drug should have been withdrawn and why it should not be used

A study out this week indicates that new “black box” warnings and safety withdrawals have increased since the drug approval process was changed

In a response to my column,1 Hackett criticises the study by Finkle et al, which investigated about 55 000 men prescribed testosterone, considerably more than any previously published study assessing the cardiovascular risk of testosterone products.2 It found a significantly increased rate of non-fatal myocardial infarction in the three months after initial testosterone prescription compared with the previous year.3 Hackett challenges the validity of using non-fatal myocardial infarction as …

Drugs containing testosterone are promoted and prescribed differently in the US and the UK, Sidney M Wolfe explains

In 1997, the Australian drug company QRx took out a US patent entitled, “Production of analgesic synergy by co-administration of sub-analgesic doses of a mu opioid agonist and a kappa-2 opioid agonist” for MoxDuo, a combination pill containing morphine and oxycodone.1 Early in its development, according to the FDA, QRx stated that its product “would provide a synergistic effect resulting in the need for lower overall opioid doses and an improved safety profile.”2 In a November 2012 memo referring to the results of a recently completed randomized clinical trial on MoxDuo, the company stated: “The 75 year search for a product having opioid efficacy without the typically associated adverse events has been compared with that for the Holy Grail.”1 The company was referring to a review of the history of opioid research in the British Journal of Pharmacology .3 The QRx memo continued, “To the best of our knowledge, MoxDuo IR [instant release] is the first opioid product to demonstrate a lower risk of respiratory depression in a clinical study comparing morphine equivalent (equianalgesic) doses. These important benefits provide the potential for …

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.

In June 2014, the US Food and Drug Administration (FDA) for the first time issued draft guidance for the pharmaceutical industry on distributing scientific and medical publications about the risks of approved prescription drugs and biological products.1 In my view, the draft guidance, which is open for public comment until August 25, 2014,2 has the potential to undermine the FDA’s drug safety laws and regulations and should be changed. As written, the draft guidance would allow pharmaceutical companies who believe that the FDAapproved drug-labeling information overstates the risks of their drug to tell physicians that the risks are, in fact, lower. Companies could inform physicians of the purportedly lower risks by distributing peer-reviewed articles and instructing their sales representatives to discuss the information they contain about the lower risks.1 Laws and regulations requiring FDA approval of the drug label would have little meaning if a company, without the agency either reviewing the data or approving it, can disseminate this information in this manner (ie, through “detailing”). In analogy to the off-label promotion of unapproved uses of drugs, this activity might be referred to as “off-label risk reduction.” A guidance represents the FDA’s “current thinking on a topic”; it is not legally binding.1 Unlike a new law that requires congressional approval or a regulation that has to go through a more stringent regulation and rulemaking process, a guidance is a less formal way of indicating, in this case to the pharmaceutical industry, that the FDA would not object if a company engaged in specified activities. The draft guidance states that1(p6) FDA does not intend to object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling, and is distributed by a firm in the form of a reprint or digital copy of a published study, if the study or analysis and the manner of distribution meet the [specified] principles....

Recently there have been strong, public arguments in the United States criticizing the lack of informed consent concerning risks in a US National Institutes of Health (NIH)-funded multi-center study called SUPPORT, which randomized 1316 extremely premature babies—average weight 2 lb, average gestation 26 weeks—to be maintained at higher (91-95%) or lower (85-89%) oxygen saturation levels after delivery. Conversely, investigators involved in this study, some ethicists, the NIH Director and his top officials and others, including medical journals, have staunchly defended this lack of informed consent. What underlies this sharp disagreement? Central to this dispute are conflicting views as to whether SUPPORT and similar studies are more like experiments or more like the existing standards of care.In March, the US government’s Office of Human Research Protections (OHRP), pursuant to a complaint about the SUPPORT study two years ago, concluded its investigation with a letter1 to the lead site in the trial, the University of Alabama in Birmingham (UAB), criticizing multiple instances of the lack of information about risks in the consent forms,2 compared with the discussion of such risks in the protocol for the study.3In particular, the study protocol makes clear that …