“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.”
“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.”
“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.”
Chemistry World: 100 years of the FDA (2006) by Fiona Case
“How not to collaborate with a biostatistician. This is what happens when two people are speaking different research languages! My current workplace is nothing like this, but I think most biostatisticians have had some kind of similar experiences like this in the past!”
YouTube: Biostatistics vs. Lab Research by JavaMama926
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.
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”.
The Profits of Nonprofit
The surprising results when drug development and altruism collide
January 1, 2011|
“In 2002, the company identified a promising off-patent antibiotic once cast aside by a large pharmaceutical company for its lack of profitability. Since the drug had been previously approved and marketed in the late 1950s as a broad-spectrum antibiotic, iOWH was able to skip directly to a phase III clinical trial to test the drug as a treatment for visceral leishmaniasis. The trial commenced in 2003, and just three years later—record time in the drug development world—paromomycin was approved for sale in India…”
“Though the idea of a nonprofit pharmaceutical company is still new, nonprofit foundations and institutes have long been a staple in biomedical research funding in the United States. But they too are breaching the barriers between profit and nonprofit, adopting best practices from the for-profit business world…”
“Victoria Hale has also made a move toward borrowing business strategies, this time not only to enable nonprofits to develop drugs, but to make and market them without Big Pharma’s help. In 2008, she left iOWH to found a “second-generation” nonprofit pharmaceutical company called Medicines360. With a focus on women and children’s health, Medicines360 aims to become self-sustaining over time, using revenue from sales of its products at a premium price in the West to subsidize the same products for those who can’t afford them in developing countries. The company is currently developing an intrauterine device (IUD) for contraception…”
“In the United States, L3Cs, low-profit, limited-liability companies, now bridge that gap. Eight states have passed legislation that permits the creation of L3Cs—defined as socially beneficial for-profit ventures. Many companies have adopted the status, including alternative-energy companies, newspapers, and food companies, but no pharmaceutical or biotech company has yet attempted the model, according to L3C experts. That’s not to say they won’t, however.”
The Scientist: The Profits of Nonprofit
A population of healthy volunteers that are full-time tests subjects for clinical trials in the pharmaceutical industry
The New Yorker: Guinea-Pigging