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.

The Polypill

Wonderful name and another potential triumph of modern medicine. What is the polypill? Well let this October 13th 2022 article from https://medicalxpress.com/ explain.

Global health has paid a deadly price for not using simple, low-cost blood pressure lowering drugs, statins and aspirin widely in the form of a single pill, also known as the polypill, say two leading cardiologists in a commentary published in The Lancet. Widespread availability of polypills would substantially reduce the risk of cardiovascular disease (CVD) and be affordable for most people globally, says their call-to-action.

"Despite substantial scientific evidence of the high effectiveness, safety and affordability of the polypill, few such combined products are available, and in the few countries where they are available, use is low," says Prof Fausto Pinto, President of the World Heart Federation.

"This systemic failure is a global tragedy, as many premature deaths from CVD could be avoided," says Prof Salim Yusuf, Executive Director of the Population Health Research Institute (PHRI) and Professor Emeritus of Medicine at McMaster University.

About 54 million people suffer from cardiovascular disease every year—a third of them die from CVD—with 80 percent of them living in low-income and middle-income countries.

Most heart attacks and strokes afflict people who have no prior CVD, meaning that primary prevention of the first heart attack or stroke is essential. Secondary prevention for people who already have CVD is also important but does not have the same impact.

"The current strategy for primary and secondary prevention of CVD has only been modestly successful in most countries, including high-income countries. Even in these countries, fewer than half of patients with prior CVD, and fewer than 20% without prior CVD, receive effective preventive treatments," says Prof Yusuf.

The polypill, also known as fixed-dose combination (FDC) therapy—with the combination of blood pressure lowering agents, a statin for lowering LDL cholesterol, and low-dose aspirin—was proposed in the early 2000s as a means to reduce CVD substantially and at low cost.

"The answer is now clear and resounding, with data from three independent, large, and long-term trials in primary prevention and one in secondary prevention showing its life-saving significance," says Yusuf, whose various publications have shown that heart attacks and strokes were cut by 35 to 50 percent by using a polypill.

"It is time to use the polypill widely to save millions of lives each year," says Prof Pinto. He and Prof Yusuf recommend the following new strategies:

Encourage large pharmaceutical companies to invest in developing and testing polypills—in particular, newer polypills with larger blood pressure lower effects (such as combining low doses of 3 or 4 classes of drugs with statins and low doses of aspirin). Manufacturing with generic components, and marketing polypills at locally sensitive prices, would ensure affordability while maintaining profitability for the companies, thereby enhancing use by the majority of people around the world.

Include polypills in the WHO's Essential Medicines List, and in guidelines for both primary and secondary prevention of CVD is an important next step. "This would encourage governments and insurance companies, especially in low-income and middle-income countries to include in their formularies, and clinicians to recommend its use," Pinto and Yusuf write.

Combine the polypill with lifestyle advice for CVD prevention delivered by trained non-physician health workers (NPHWs)—not meant as a replacement for physicians who can use their advanced skills on managing individuals with more complex conditions—thus a combined strategy that would help many more people.

Clearly the time has never been more opportune to push these polypills given the "fallout" from the Covid vaccinations. The time-worn trick is being played again, exacerbate an existing problem via pharmaceuticals and then propose a pharmacological solution. To quote from the article:

Encourage large pharmaceutical companies to invest in developing and testing polypills ...

Let's not forget the WHO. To quote again:

Include polypills in the WHO's Essential Medicines List

These are the sorts of solutions that one would expect from the medical establishment.  No investigation into the reasons for the uptick in CVD, just a new pill. Stay healthy and cheat death (for a while at least) with the help of BIG PHARMA.

The Fuster-CNIC-Ferrer cardiovascular polypill combines three drugs into one pill to make it easier
for patients to comply with secondary cardiovascular prevention therapy. Link.

I think we'll be seeing more of polypills in the future. Here's an October 13th 2022 headline from CNN Health:

Combination ‘polypills’ can help solve world’s heart problems, experts say, if more people can get them

Well, the "experts" are saying so you'd better listen. The pharmaceutical companies will need to come up with new patented drugs to pack into these polypills so as to make them as expensive as possible. As usual, third world countries will need to spend money allocated to their health care budgets to buy these new medications along with all the other crap that the WHO is foisting on them. Even if you're feeling well and are young and seemingly healthy, you'll be encouraged to take them as a prophylactic. The more young people that keep dropping dead on sporting fields or dying in their sleep, the more people will opt to take them. Most of the elderly are already dependent on several medications and will need no persuasion to use them.