Data Fraud in Clinical Trials

“Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data fraud in clinical trials, describe several prominent cases, present information on motivation and contributing factors and discuss cost-effective ways of early detection of data fraud as part of routine central statistical monitoring of data quality. Adoption of these clinical trial monitoring procedures can identify potential data fraud not detected by conventional on-site monitoring and can improve overall data quality.”


Source

NCBI: Data fraud in clinical trials

Barbershop-Based Healthcare Study Lowers High Blood Pressure in African-American Men

“New England Journal of Medicine: Nearly 64% Reduced Their Blood Pressure to Healthy Levels After Barbers Promoted Follow-Up With Pharmacists in the Barbershops.

“African-American men lowered their high blood pressure to healthy levels when aided by a pharmacist and their barber, according to a new study from the Smidt Heart Institute.”


Source

Cedars Sinai: Barbershop-Based Healthcare Study Lowers High Blood Pressure in African-American Men

100 years of the FDA

“The 1906 pure food and drug act was set up to protect US citizens from unregulated and potentially harmful products. Implementing the regulation has presented the US Food and Drug Administration with many high-profile challenges, as Fiona Case finds out.”

Read more


Source

Chemistry World: 100 years of the FDA (2006) by Fiona Case

Invalidating Bloodletting with Science

Blood on the Tracks – Podcast Episode 38

Learn about a piece of epidemiological history: one of the earliest examples of population-level clinical studies influencing medical practice. This podcast tells the story of how French physician Pierre Charles Alexandre Louis studied a group of patients and ended up discovering quantitative evidence on the detriment of bloodletting. Learning the history helps place these tools in a broader context, which isn’t crucial, but interesting nonetheless.

Listen to the Podcast here

The first population study in history was born out of a dramatic debate involving leeches, “medical vampires,” professional rivalries, murder accusations, and, of course, bloodletting, all in the backdrop of the French Revolution. The second of a multipart series on the development of population medicine, this episode contextualizes Pierre Louis’ “numerical method,” his famous trial on bloodletting, and the birth of a new way for doctors to “know”.


Source

Bedside Rounds: Episode 38: Blood on the Tracks (PopMed #2)

Public Health in the Precision-Medicine Era

Ronald Bayer, Ph.D., and Sandro Galea, M.D., Dr.P.H.

“The NIH’s most recent Estimates of Funding for Various Research, Condition, and Disease Categories report (www.report.nih.gov/categorical_spending.aspx) shows, for example, that total support in fiscal year 2014 for research areas including the words ‘gene,’ ‘genome,’ or ‘genetic’ was about 50% greater than funding for areas including the word ‘prevention.’…The proportion of NIH-funded projects with the words ‘public’ or ‘population’ in their title, for example, has dropped by 90% over the past 10 years, according to the NIH Reporter.”

“Without minimizing the possible gains to clinical care from greater realization of precision medicine’s promise, we worry that an unstinting focus on precision medicine by trusted spokespeople for health is a mistake — and a distraction from the goal of producing a healthier population.”

Read More


Source

NEJM: Public Health in the Precision-Medicine Era by Ronald Bayer, Ph.D., and Sandro Galea, M.D., Dr.P.H.

Earthlings (2005)

Earthlings is a 2005 American documentary film about humankind’s total dependence on animals for economic purposes.  Presented in five chapters (pets, food, clothing, entertainment and scientific research) the film is narrated by Joaquin Phoenix, featuring music by Moby, and was written, produced and directed by Shaun Monson.”


How Not to Die describes the numerous health benefits of eating a plant-based diet. After reading through half the book, I watched Earthlings to see arguments from the animal rights activists for eliminating animal products from the dinner table. Personal health has always been my primary interest for minimizing meat consumption. But the message in this documentary is just as difficult to ignore as it is to watch.

There are some valid counter arguments to abandoning meat, which are listed in this reddit thread. The most compelling was that from an Indian man who argues he will not stop eating meat nor stop providing it for his family because he has genuine concern that his children my not survive due to malnutrition. Perhaps citizens of the more developed nations are the primary audience for this documentary.

I have watched a handful of anti-meat documentaries, and often they appeal to emotions such as shame, guilt, or anger. Earthlings takes a more objective role, showing film of industrial animal manufacturing in the United States. It was refreshing to be treated as a neutral observer, instead of being reprimanded. There are definite appeals to emotion, but the dialogue in the documentary is more calm than any I’ve seen before.

Earthlings has made me reconsider my current relationship with meat and animal products.  I imagine I have grown up with more livestock experience than many of my neighbors. I learned from my family to slaughter fish, chickens, turkeys, and rabbits for food. I attempted a pescatarian diet for several years in my twenties, but only for personal health reasons. This is the most cognizant I have been of my indirect participation in the massive consumption of animals, and what that actually means.


Three Stages of Truth

  1. Ridicule
  2. Violent Opposition
  3. Acceptance

Attributed to German Philosopher Arthur Schopenhauer (1788–1860)


Sources

Does Pure Nicotine Cause Cancer?

Cigarettes contain many chemicals that increase the risk of cancer. Polycyclic hydrocarbons and tobacco-specific N-nitrosamines are some of the more well-known carcinogens in this class.

But now, e-cigarettes appear to be isolating nicotine, and leaving behind many of the old toxins from cigarettes. This sounds like e-cigarettes may be “better” for the modern smoker. Are smokers of e-cigarettes increasing their chances of cancer later in their lives? If so, what is the risk of cancer from smoking pure nicotine?

For the sake of discussion, let’s ignore the possibility for novel cancer-inducing chemicals introduced from the various oils and heating mechanisms in e-cigarettes. Let’s assume it is possible to have a method of smoking that only exposes the smoker to nicotine and nothing else. Would this method of smoking still cause cancer?

This review of the literature on Nicotine from 2015 suggests the answer is “yes”. Nicotine alone still increases the risk of cancer for the smoker of pure nicotine.

“Several lines of evidence indicate that nicotine may contribute to the development of cancer.

“Evidence from experimental in vitro studies on cell cultures, in vivo studies on rodents as well as studies on humans inclusive of epidemiological studies indicate that nicotine itself, independent of other tobacco constituents, may stimulate a number of effects of importance in cancer development (5, 6).”


Source

NCBI: Nicotine: Carcinogenicity and Effects on Response to Cancer Treatment – A Review

The Expanding Scope of Psychiatric Epidemiology in the 21st Century

“The series of reviews commissioned by SPPE over the past year shed important insights on the current state of psychiatric epidemiology [1-5]. Our reading of this series has led us into discussions of the scope and goals of our discipline, and how, within a historical context, it is expanding in both predicted and unforeseen ways. In this editorial we first reflect on the history of our field, and how the wealth of information in these reviews provides insight into newly emerging directions of inquiry. Then we discuss major advances and remaining challenges in the field not covered in the series. Finally, we consider the overall scope and future directions of psychiatric epidemiologic inquiry in the years to come.”


Source

NCBI: The expanding scope of psychiatric epidemiology in the 21st century

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