Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Saturday, 26 November 2022

MEDICAL DEVICES

It was a tweet that alerted me to a documentary about the dangers of medical devices. The video was released in 2018 on Netflix and, since I'd cancelled my subscription to that service, I had to go looking for it. I found without much trouble on the Internet Archive located at this address. This came as something of a surprise.

It was an unsettling film that focused on what went terribly wrong with particular types of hip socket replacements, meshes, contraceptive devices and robotic surgery The documentary highlighted the glaring deficiencies in the approval process for these devices, the deceptive marketing and poor reporting of adverse side effects in patients.

One person interviewed commented that the medical technology industry had more influence than Big Pharma. Medical devices require only one trial on a group of patients instead of two for pharmaceutical products and grandfathering permits the possibility of no trial at all. If it can shown that a new device requiring approval is not substantially different from an earlier one that has already gained approval, then no trial is needed. This grandfather loophole has been egregiously exploited by those peddling their medical technology wares.

At the heart of the problem lies the so-called "revolving door" that means that highly placed officials at the FDA (or its equivalent in other countries) are given jobs in the medical technology industry after leaving the agency or prominent figures in the industry are appointed to high level jobs in the FDA. This is exactly the same as what happens in the pharmaceutical industry. The industry ends up overseeing itself. 

Some medical devices are useful and even life saving but care needs to be taken before making use of them. The problem is that prospective patients simply take the medical professional's word that the device is safe which can prove a dangerous mistake. As technology progresses inexorably, it's likely that more medical devices will be aggressively marketed without proper safety studies being carried out.

The documentary is just another reminder of how badly the medical "profession" has failed to work in the best interests of its patients. It's therefore up to the patients to work out what's the best solution to their health problems. They need to take charge of their own health and not passively accept the advice of a doctor who may well be ill-informed, acting in their own self-interest or simply uncaring.

Saturday, 18 April 2020

PRENATAL ULTRASOUNDS

In Jeanice Barcelo's "The Dark Side of Prenatal Ultrasound", the dangers of the procedure are laid out in great detail with a plethora of supporting evidence. In this post, I won't go into all the reasons why such uterine intrusions should be avoided. These are comprehensively covered in the book. The author also has a website titled "Birth of a New Earth". 

However, ultrasounds are a routine part of prenatal medical care in most wealthy countries. In less wealthy countries, many foetuses are fortunately spared the procedure because families cannot afford it. Medical prenatal ultrasounds carry dubious benefits and a great many dangers but it came as a surprise to me that the procedures are being carried for reasons that have nothing to do with medicine.

A Florida establishment going by the name of Sweet Baby O'Mine advertises on its website as shown in Figure 1:

Figure 1

The smiling mother and daughter team offer to bombard your baby-to-be with two 25 minute sessions of ultrasound (1st Session: between 14-27 weeks and 2nd Session: after 27 weeks) if you choose the most expensive package that costs $250. What you get is "an Adorable Movie of Your Lil' Baby Moving Inside the Womb ~ Great for Family Movie Night!". 

Of course, once born the baby will become a vaccine pin cushion, but the assault begins even before birth. Mothers who visit Sweet Baby O'Mine will still undergo the medical ultrasounds as part of their prenatal monitoring. Having being told the procedure is absolutely safe, these mothers are oblivious of the health hazards and sadly have complete trust in what their health care professionals tell them. 

Figure 2

Ultrasound is a tool that may well be useful in probing the interiors of our body but not a baby-to-be. Interestingly and surprisedly, even the United States FDA (Food and Drug Administration) issued a warning about ultrasounds as reported in this 2nd of April 2015 video:


Here is another video on the so-called 3-D "keepsake" ultrasounds from March 2015 that I discovered on a YouTube search. However, I couldn't find anything on YouTube after that date. I would surmise that the ultrasound lobby went into overdrive after these news stories appeared on mainstream media.


The following video (dating from 2010) featuring Dr. Robert Mendelsohn warns about the dangers of ultrasound procedures that at first sight do not seem to involve the use of ultrasound:



The information attached to this video contains some potentially useful references that can no longer be found thanks no doubt to the ultrasound lobby. Figures 3 and 4 shows two examples.

FDA Cautions Against Ultrasound "Keepsake" Images (see Figure 3)
http://www.sdms.org/pdf/FDAKeepsake.pdf 

Figure 3


Ultrasound and the Alarming Increase in Autism (see Figure 4):
http://midwiferytoday.com/articles/ultrasoundrodgers.asp

Figure 4

The latest news that I could find has less to do with ultrasound safety and more to do with abortion legislation. Nonetheless, the news article of March 12th 2020 is of interest. Here is an excerpt:
Utah’s six female senators — Republican and Democratic — left the chamber in protest Tuesday, refusing to vote on a bill that requires women to undergo an ultrasound and be presented with video and audio of their developing foetus before terminating a pregnancy.