Surrogate end points in clinical research: hazardous to your health. – PubMed – NCBI – Obstet Gynecol. 2005 May
Surrogate end points in clinical research pose real danger.
A surrogate end point is an outcome measure, commonly a laboratory test, that substitutes for a clinical event of true importance.
Resistance to activated protein C, for example, has been used as a surrogate for venous thrombosis in women using oral contraceptives.
Other examples of inappropriate surrogate end points in contraception include the Continue reading
CRISPR gene editing can cause hundreds of unintended mutations | EurekAlert! Science News – May 29, 2017
This is an example of how new drugs developed with the latest new technologies can lead to dangerous unintended side-effects that only become apparent later after many subjects have been “treated”.
When a new technology, like CRISPR gene editing, is used we cannot use past experience to assume anything and cannot predict results precisely because we’re doing something categorically different from before.
As CRISPR-Cas9 starts to move into clinical trials, a new study published in Nature Methods has found that the gene-editing technology can introduce hundreds of unintended mutations into the genome. Continue reading
Lawmakers and practicing medicine without a license – Law Stack Exchange
Again and again we see lawmakers pass laws (generally in the context of abortion) that
- direct doctors to provide medically incorrect information or
- engage in acts which are medically unsound, or
- to not provide medical information beneficial to the patient.
How is this not engaging in the practice of medicine? Why are they not prosecuted for such behavior?
It turns out that lawmakers have special rights, known as legislative immunity (link to Wikipedia article with explanation), which allows them to enact laws. Continue reading
How statistics are twisted to obscure public understanding | Aeon Ideas – 11 July, 2016 – Jonathan R Goodman
In every industry, from education to healthcare to travel, the generation of quantitative data is considered important to maintain quality through competition.
Yet statistics rarely show what they see.
If you look at recent airline statistics, you’ll think that a far higher number of planes are arriving on schedule or early than ever before. But this appearance of improvement is deceptive.
Airlines have become experts at appearance management: by listing flight times as 20-30 percent longer than what the actual flight takes, flights that operate on a normal to slightly delayed schedule are still counted as arriving ‘early’ or ‘on time’. A study funded by the Federal Aviation Administration refers to the airline tactic as schedule buffering. Continue reading
Counterfeit Drugs: The Silent Epidemic | Do No Harm – May 27, 2012 – by Do No Harm Inc.
As much as 15% of medicines in the world are counterfeit thus causing 100,000 deaths worldwide according to the WHO. The increase of counterfeit drugs across the world in the last decade is both a consequence and a symptom of one phenomenon: the globalization of drugs production and distribution. The supply chain of medicines has become increasingly fragmented and scattered across the globe with raw material extraction taking place in one country and ingredients synthesis and formulation in another country. This globalized supply chain has two implications:
It makes the counterfeit drugs problem not an exclusivity of developing countries: developed countries are as much exposed to this risk as least developed countries.
If the problem is global, the solution has to be global too. As long as pharmaceutical companies source their active pharmaceuticals ingredients (APIs) in other countries any regulation which is purely domestic is bound to be ineffective. Continue reading
Prediction of CYP2D6 phenotype from genotype across world populations – Genet Med. 2017 Jan; – free full-text PMC article
Owing to its highly polymorphic nature and major contribution to the metabolism and bioactivation of numerous clinically used drugs, CYP2D6 is one of the most extensively studied drug-metabolizing enzymes and pharmacogenes.
CYP2D6 alleles confer no, decreased, normal, or increased activity and cause a wide range of activity among individuals and between populations.
I’ve added a glossary of genetic terms at the end of this post. Continue reading
Quackery infiltrates The BMJ – Science-Based Medicine – David Gorski – May 22, 2017
Is LACK of EVIDENCE the same as/equate to QUAKERY?
We here have long lamented the creeping infiltration of quackery into medical academia in which modalities once considered quackery, such as
- reiki, naturopathy,
- homeopathy, and
- various other dubious treatments,
have found their way into what should be bastions of science-based medicine (SBM). Continue reading
FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
This information is an update to the FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together issued on May 12, 2016
Some signs and symptoms of serious side effects include:
- unusual joint or tendon pain,
- muscle weakness,
- a “pins and needles” tingling or pricking sensation,
- numbness in the arms or legs,
- confusion, and
Tolerating Uncertainty — The Next Medical Revolution? — NEJM – Nov 2016;
Our quest for certainty is central to human psychology, however, and it both guides and misguides us.
Although physicians are rationally aware when uncertainty exists, the culture of medicine evinces a deep-rooted unwillingness to acknowledge and embrace it.
Embodied in our teaching, our case-based learning curricula, and our research is the notion that we must unify a constellation of signs, symptoms, and test results into a solution. Continue reading
Welcome to STAT 509: Clinical Trials – Pennsylvania State University
Though this is an actual course, I found it useful as a quick reference when I wanted to understand some aspect of statistics being using in a study. Below, I’ve listed direct links to the 19 chapters/topics of statistics used in clinical trials.
This course is a survey of statistical methods and study design issues related to the testing of medical treatments.