Tag: United States

BPF and BPS linked to obesity in children and teens

Urinary bisphenols and obesity prevalence among US children and adolescents, 2019

Bisphenol S (BPS) and bisphenol F (BPF), used as substitutes for bisphenol A (BPA), may contribute to childhood weight gain and obesity, according to a new study published today in the Journal of the Endocrine Society, the Environmental Health News reports.
Image credit Drouin Secondary College.

“Replacing BPA with similar chemicals does nothing to mitigate the harms chemical exposure has on our health.
It will continue to be an issue given that human exposure to these compounds is likely to continue to increase in the future.”

2019 Study Abstract

Bisphenol A (BPA) has been recognized as an endocrine disrupting chemical and identified as an obesogen. Although once ubiquitous, human exposure to BPA is declining due to its substitution with other bisphenols. Two structurally similar substitutes, bisphenol S (BPS) and bisphenol F (BPF), have raised similar concerns, although fewer studies have been conducted on these newer derivatives. We used data from the US National Health and Nutrition Examination Surveys from the years 2013-2016 to evaluate associations between BPA, BPS, and BPF and body mass outcomes among children and adolescents aged 6 to 19 years. Concentrations of BPA, BPS, and BPF were measured in spot urine samples using high performance liquid chromatography with tandem mass spectrometry. General obesity was defined as ≥95th percentile of age- and sex-standardized body mass index (BMI) z-scores according to 2000 US norms. Abdominal obesity was defined as ratios of waist circumference to height ≥0.5. BPA, BPS, and BPF were detected in 97.5%, 87.8% and 55.2% of urine samples, respectively. Log-transformed urinary BPS concentrations were associated with an increased prevalence of general obesity (OR=1.16, 95% CI: 1.02, 1.32) and abdominal obesity (OR=1.13, 95% CI: 1.02, 1.27). BPF detection (vs. not detected) was associated with an increased prevalence of abdominal obesity (OR=1.29, 95% CI: 1.01, 1.64) and continuous BMI z-score (β=0.10, 95% CI: 0.01, 0.20). BPA and total bisphenols were not statistically significantly associated with general obesity, abdominal obesity, or any body mass outcome. This study suggests that BPA substitute chemicals are correlated with obesity in contemporary children.

Angell on Big Pharma

Some more truth about the pharmaceutical companies

Do pharmaceutical companies corrupt academic research and the clinical trial process ? You bet.

Dr Marcia Angell of Harvard Medical School and the author of The Truth About the Drug Companies talks with EconTalk host Russ Roberts about the impact of pharmaceutical companies on academic research, clinical trials and the political process. Angell argues that the large pharmaceutical companies produce little or no innovation and use their political power to exploit consumers and taxpayers. Reference.

To Err is Human : Building a Safer Health System

Institute of Medicine (US) Committee on Quality of Health Care in America, 2000

Patient safety has made great progress since the publication of To err is human 20 years ago but there is much more to do.

Excerpt

Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That’s more than die from motor vehicle accidents, breast cancer, or AIDS – three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems.

To Err Is Human (free full text) breaks the silence that has surrounded medical errors and their consequence–but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agenda–with state and local implications–for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients’ expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errors–which begs the question, “How can we learn from our mistakes?” Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care.

To Err Is Human (free full text) asserts that the problem is not bad people in health care–it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocates–as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine.

July 2019 : read The NHS Patient Safety Strategy, safer culture, safer systems, safer patients.

Pharma sales rep paid physicians to participate in hundreds of sham “speaker programs” in order to prescribe med drugs

Subsys : Drug Company Sales Rep Sentenced for Role in Kickback Scheme Related to Fentanyl Spray Prescriptions

John H. Durham, United States Attorney for the District of Connecticut, announced that NATALIE LEVINE, 35, of Scottsdale, Arizona, was sentenced today by U.S. District Judge Janet Bond Arterton in New Haven to five years of probation for engaging in a kickback scheme related to fentanyl spray prescriptions. Judge Arterton also ordered Levine to spend the first six months of probation in home confinement, and to perform 150 hours of community service.

According to court documents and statements made in court, from approximately March 2013 to October 2014, Levine was employed by Insys Therapeutics, an Arizona-based pharmaceutical company that manufactured and sold Subsys, a fentanyl-based sublingual spray that was approved by the Food and Drug Administration solely for the management of breakthrough pain in cancer patients. Levine was a sales representative for the company and was responsible for covering the territories that included Connecticut, New Hampshire and Rhode Island.

Levine induced certain medical practitioners, including an advanced practice registered nurse (APRN) in Connecticut, a physician’s assistant (PA) in New Hampshire, and a physician in Rhode Island, to prescribe Subsys by paying them to participate in hundreds of sham “Speaker Programs.” The Speaker Programs, which were typically held at high-end restaurants, were ostensibly designed to gather licensed healthcare professionals who had the capacity to prescribe Subsys and educate them about the drug. In truth, the events were usually just a gathering of friends and co-workers, most of whom did not have the ability to prescribe Subsys, and no educational component took place. “Speakers” were paid a fee that ranged from $1,000 to several thousand dollars for attending these dinners. At times, the sign-in sheets for the Speaker Programs were forged so as to make it appear that the programs had an appropriate audience of healthcare professionals.

The medical practitioners were paid thousands of dollars in illegal kickbacks in order to prescribe Subsys, and induce others to prescribe Subsys, over similar medications. Medicare Part D plans authorized payment for hundreds of Subsys prescriptions written by the three medical practitioners, resulting in a loss of approximately $4.5 million.

Levine’s restitution figure will be determined after additional court proceedings.

On July 11, 2017, Levine pleaded guilty to one count of conspiracy to violate the anti-kickback law.

Several other individuals affiliated with Insys Therapeutics, and medical practitioners involved in this kickback scheme, have been charged and convicted in the District of Connecticut and in other Districts across the United States. In sentencing Levine, Judge Arterton credited Levine’s significant cooperation and assistance to the government’s prosecution of defendants in Connecticut, Massachusetts, New Hampshire and Rhode Island.

On January 3, 2019, Levine’s husband, Michael Babich, who was the CEO and President of Insys Therapeutics, pleaded guilty in the District of Massachusetts to conspiracy and fraud charges stemming from the scheme. He awaits sentencing.

On May 2, 2019, a federal jury in Boston found John N. Kapoor, the founder and former Executive Chairman of Insys Therapeutics, and four other former Insys executives guilty of racketeering conspiracy.

Earlier this month, Insys Therapeutics agreed to pay a total of $225 million to resolve criminal and civil investigations of the company.

The investigation in the District of Connecticut is being conducted by the U.S. Department of Health and Human Services Office of the Inspector General and the Federal Bureau of Investigation, with the assistance of the Drug Enforcement Administration’s Tactical Diversion Squad. The case is being prosecuted by Assistant U.S. Attorneys Douglas P. Morabito, Sarah P. Karwan and Richard M. Molot.

U.S. Attorney Durham encouraged individuals who suspect health care fraud to report it by calling the Health Care Fraud Task Force (203) 785-9270 or 1-800-HHS-TIPS.

Department of Justice
U.S. Attorney’s Office, District of Connecticut, News And Press Releases, Monday June 24, 2019

May Processed Foods Hold Key to Rise in Autism ?

Propionic Acid Induces Gliosis and Neuro-inflammation through Modulation of PTEN/AKT Pathway in Autism Spectrum Disorder

With the number of children diagnosed with autism on the rise, the need to find what causes the disorder becomes more urgent every day.
UCF researchers are now a step closer to showing the link between the food pregnant women consume and the effects on a fetus’ developing brain.

2019 Study Abstract

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by glia over-proliferation, neuro-inflammation, perturbed neural circuitry, and gastrointestinal symptoms. The role of gut dys-biosis in ASD is intriguing and should be elucidated.

We investigated the effect of Propionic acid (PPA), a short-chain fatty acid (SCFA) and a product of dys-biotic ASD gut, on human neural stem cells (hNSCs) proliferation, differentiation and inflammation.

hNSCs proliferated to 66 neuropsheres when exposed to PPA versus 45 in control. The neurosphere diameter also increased at day 10 post PPA treatment to (Mean: 193.47 um ± SEM: 6.673 um) versus (154.16 um ± 9.95 um) in control, p < 0.001. Pre-treatment with β-HB, SCFA receptor inhibitor, hindered neurosphere expansion (p < 0.001). While hNSCs spontaneously differentiated to (48.38% ± 6.08%) neurons (Tubulin-IIIβ positive) and (46.63% ± 2.5%) glia (GFAP positive), PPA treatment drastically shifted differentiation to 80% GFAP cells (p < 0.05). Following 2 mM PPA exposure, TNF-α transcription increased 4.98 fold and the cytokine increased 3.29 fold compared to control (P < 0.001). Likewise, GPR41 (PPA receptor) and pro-survival p-Akt protein were elevated (p < 0.001). PTEN (Akt inhibitor) level decreased to (0.42 ug/ul ± 0.04 ug/ul) at 2 mM PPA compared to (0.83 ug/ul ± 0.09 ug/ul) in control (p < 0.001). PPA at 2 mM decreased neurite outgrowth to (80.70 um ± 5.5 um) compared to (194.93 um ± 19.7 um) in control.

Clearly, the data supports a significant role for PPA in modulating hNSC patterning leading to gliosis, disturbed neuro-circuitry, and inflammatory response as seen in ASD.

A complete and comprehensive ban on fracking is needed to mitigate its grave harm to public health and the climate

Compendium of Scientific, Medical, and Media Findings Demonstrating Risks and Harms of Fracking (Unconventional Gas and Oil Extraction), Sixth Edition, June 19, 2019

A group of doctors and scientists have released a comprehensive report highlighting that 84 percent of studies published from 2009-2015 on the health impacts of fracking conclude the industry causes harm to human health, Environmental Health News reports.
Concerned Health Professionals of New York compendium.

Abstract

Conclusion

All together, findings to date from scientific, medical, and journalistic investigations combine to demonstrate that fracking poses significant threats to air, water, human health, public safety, community cohesion, long-term economic vitality, biodiversity, seismic stability, and climate stability.

The rapidly expanding body of scientific evidence compiled and referenced in the present volume is massive, troubling, and cries out for decisive action. Across a wide range of parameters, from air and water pollution to radioactivity to social disruption to greenhouse gas emissions, the data continue to reveal a plethora of recurring problems and harms that cannot be sufficiently averted through regulatory frameworks.There is no evidence that fracking can operate without threatening public health directly and without imperiling climate stability upon which public health depends. The only method of mitigating its grave harm to public health and the climate is a complete and comprehensive ban on fracking.

In the words of investigative journalist Andrew Nikiforuk:

Industry swore that its cracking rock technology was safe and proven, but science now tells a different story. Brute force combined with ignorance … has authored thousands of earthquakes … [and] called forth clouds of migrating methane…. The science is complicated but clear: cracking rock with fluids is a chaotic activity and no computer model can predict where those fractures will go. The regulatory record shows that they often go out of zone; extend into water; and rattle existing oil and gas wells, and these rattled wells are leaking more methane.

In closing, we cite comments by epidemiologist Irena Gorski, co-author of the 2019 review of fracking’s health concerns published in the Oxford Research Encyclopedia of Global Public Health. Her words speak for all who have contributed to this Compendium:

What we found pushes back against the narrative we often hear that say we don’t know enough about the health impacts yet. We have enough evidence at this point that these health impacts should be of serious concern to policymakers interested in protecting public health….As a fossil fuel, natural gas extraction and use is contributing to climate change, of course. But before conducting this study, I didn’t realize the amount of evidence we have that it may be even worse than coal. We included this in our study because climate change has its own contributions to health impacts. These indirect impacts will take longer to appear than the direct health impacts, but they have the potential to be significant.

Human Consumption of Microplastics

You could be swallowing a credit card’s weight in plastic every week

Globally, we are ingesting an average of 5 grams of plastic every week, the equivalent of a credit card, a new study suggests.

Abstract

Microplastics are ubiquitous across ecosystems, yet the exposure risk to humans is unresolved.
Focusing on the American diet, we evaluated the number of microplastic particles in commonly consumed foods in relation to their recommended daily intake.The potential for microplastic inhalation and how the source of drinking water may affect microplastic consumption were also explored.

Our analysis used 402 data points from 26 studies, which represents over 3600 processed samples.

Evaluating approximately 15% of Americans’ caloric intake, we estimate that annual microplastics consumption ranges from 39000 to 52000 particles depending on age and sex. These estimates increase to 74000 and 121000 when inhalation is considered. Additionally, individuals who meet their recommended water intake through only bottled sources may be ingesting an additional 90000 microplastics annually, compared to 4000 microplastics for those who consume only tap water.

These estimates are subject to large amounts of variation; however, given methodological and data limitations, these values are likely underestimates.

See also CNN press release.

60 MiNueTs Toxic

UCSF Program on Reproductive Health and the Environment, 2017

Video published on 18 Apr 2019 by the UCSF Program on Reproductive Health and the Environment.

The University of California San Francisco (UCSF) Program on Reproductive Health and the Environment (PRHE)’s mission is to create a healthier environment for human reproduction and development through advancing scientific inquiry, clinical care and health policies that prevent exposures to harmful chemicals in our environment.

More Information

The Depression Pill Epidemic

The medicine drugs do not cure, lead to much harm, and should be avoided

“In some countries, including the United States, about 10% of the entire population is in treatment with depression pills. This is a tragedy. These drugs do not have relevant effects on depression; they increase the risk of suicide and violence; and they make it more difficult for patients to live normal lives. They should therefore be avoided. We have been fooled by the drug industry, corrupt doctors on industry payroll, and by our drug regulators.

Surely, many patients and doctors believe the pills are helpful, but they cannot know this, because people tend to become much better with time even if they are not treated. This is why we need placebo-controlled trials to find out what the drugs do to people. Unfortunately, virtually all trials are flawed, exaggerate the benefits of the drugs, and underestimate their harms.” …

Overview

  • Cold turkey in the placebo group
  • Lack of blinding
  • Irrelevant outcomes

… continue reading The Depression Pill Epidemic, by Professor Peter C. Gøtzsche, on crossfit, June 4, 2019.

Chronic use of tramadol after acute pain episode: cohort study

Tramadol use is associated with a higher risk of prolonged opioid use in patients with an acute episode of pain compared with other short acting opioids, finds new research

2019 Study Abstract

Objective
To determine the risk of prolonged opioid use in patients receiving tramadol compared with other short acting opioids.

Design
Observational study of administrative claims data.

Setting
United States commercial and Medicare Advantage insurance claims (OptumLabs Data Warehouse) January 1, 2009 through June 30, 2018.

Participants
Opioid-naive patients undergoing elective surgery.

Main outcome measure
Risk of persistent opioid use after discharge for patients treated with tramadol alone compared with other short acting opioids, using three commonly used definitions of prolonged opioid use from the literature: additional opioid use (defined as at least one opioid fill 90-180 days after surgery); persistent opioid use (any span of opioid use starting in the 180 days after surgery and lasting ≥90 days); and CONSORT definition (an opioid use episode starting in the 180 days after surgery that spans ≥90 days and includes either ≥10 opioid fills or ≥120 days’ supply of opioids).

Results
Of 444 764 patients who met the inclusion criteria, 357 884 filled a discharge prescription for one or more opioids associated with one of 20 included operations. The most commonly prescribed post-surgery opioid was hydrocodone (53.0% of those filling a single opioid), followed by short acting oxycodone (37.5%) and tramadol (4.0%). The unadjusted risk of prolonged opioid use after surgery was 7.1% (n=31 431) with additional opioid use, 1.0% (n=4457) with persistent opioid use, and 0.5% (n=2027) meeting the CONSORT definition. Receipt of tramadol alone was associated with a 6% increase in the risk of additional opioid use relative to people receiving other short acting opioids (incidence rate ratio 95% confidence interval 1.00 to 1.13; risk difference 0.5 percentage points; P=0.049), 47% increase in the adjusted risk of persistent opioid use (1.25 to 1.69; 0.5 percentage points; P<0.001), and 41% increase in the adjusted risk of a CONSORT chronic opioid use episode (1.08 to 1.75; 0.2 percentage points; P=0.013).

Conclusions
People receiving tramadol alone after surgery had similar to somewhat higher risks of prolonged opioid use compared with those receiving other short acting opioids. Federal governing bodies should consider reclassifying tramadol, and providers should use as much caution when prescribing tramadol in the setting of acute pain as for other short acting opioids.