Category Archives: Blog
According to a recent article published in JAMA Internal Medicine, when the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.
Now, I know what you’re thinking…. that I’m just quoting the conclusion from the abstract and hijacking title of the article without actually reading the full text. So let’s go over the full text together shall we?
As part of the drug approval process, the US Food and Drug Administration (FDA) regularly inspects clinical trial sites involved in FDA-regulated research to determine the degree to which these sites conform to regulations. They are basically allowed to audit any and all aspects of a clinical trial including the data itself, if they see fit.
As a result, the FDA inspections can result in three outcomes.
- No action indicated (no substantial violations)
- Voluntary action indicated (inspectors have found violations, but not serious enough for sanctions)
- Official action indicated (OAI) (inspectors have found violations enough to warrant regulatory action)
During a hands-on workshop, a practitioner, who happened to be a medical doctor that was very experienced in deep dry needling (45 years), was demonstrating how to needle into a deep muscle called the illiocostalis. By using his hands, he intended to use his fingers to block the intercostal spaces (the space between the ribs) and direct his needle towards the rib below. Once hitting the rib, this would be his depth indicator.
Unfortunately, this practitioner chose a 50mm needle that was too long in length for the task at hand. As the needle was inserted, it deviated to the side and went around the rib and further penetrated the patient’s lung. The practitioner then, without knowing the damage he had caused, lifted the needle and redirected it, into the rib, which is where he intended it to go the first time.
If you pay close attention, you can see the excessive depth the needle travelled the first attempt in comparison to the second attempt. To read the full story, visit the link provided below.
Full text article in British Medical Journal: Pneumothorax complication of deep dry needling demonstration