This topic is tough to discuss. The danger is that one may come across as simply a defender of the medical device industry. I'm not.
Another danger is that one may come across as a media-hater. Again, I'm not. I worked at two newspapers and one television station and have great respect for many of the folk with whom I once worked.
Medical devices are often foreign objects surgically implanted into the human body -- a damn hostile environment for many materials. Corrosion is but one of the immediate threats.
MS (multiple sclerosis). Doctors were slow to embrace the untested surgical treatment as it often involved the off-label use of a coronary artery stent being inserted in a vein in a patient's neck.
The media was quick to attack the doctors, government regulators and insurers for their reticence. The Post Media paper in London, Ontario, ran a story about a local woman unable to obtain government health care funding for the treatment.
When I looked into the wisdom of placing a stent in a patient's neck, I was told by the medical professionals questioned that they would not do it. Why? Too dangerous.
Liberation Therapy is no longer bandied about as a miraculous cure for MS. The doctors and clinics that were so quick to provide the treatment should be ashamed. Patients died having this surgery. It was a high-risk-no-reward treatment. And the press should be ashamed of the role it played in advancing this quackery.
So, is there a problem with medical devices? Yes. But it is a complex problem and the breathless reporting of patient-recipient horror stories, as I've encountered on CBC, is not the adult discussion needed.
Wednesday, November 28, 2018
My heart doesn't beat well. At least, it doesn't beat well on its own. I have a one hundred percent heart block. This a problem with my heart's electrical system and not a problem with my arteries. I'm not concerned about having a heart attack. What threatens me is heart failure. You see, on its own my heart would beat only about 30 times a minute, maybe even less. Without my pacemaker, my ankles would swell, fluid would gather in my gut and surround my heart. My lungs would fill with fluid and I'd have a difficult time breathing. Within days I'd be dead.
My pacemaker is an implanted medical device attempting to partially correct my heart's electrical system failure. It is not a perfect solution and there are problems associated with having one implanted. How anyone could think that having a chunky metal box inserted into one's chest and attached to one's heart by 26-inches of wire could possibly be risk-free puzzles me.
CBC is reporting that tens of thousands of medical devices distributed worldwide — like pacemakers — were approved for sale with little scientific evidence . . .
CBC claims devices such as pacemakers are suspected of having played a role in more than 14,000 reported injuries and 1,416 deaths. This number is so large because it includes problems associated with a number of devices, of which pacemakers are but one.
database of associated incidents. I typed pacemaker into the device category field.
I discovered 157 deaths and 1,291 patient injuries are associated with pacemakers. This is not all that surprising when the complexities of the system and the all-too-clear dangers are considered.
Simply making a pocket in a patient's chest and inserting a metal box is fraught with danger: infection, blood clots, stroke and the list just grows. And, if a problem does arise, the solution may well demand another operation. Surgery is never risk free.
What did surprise me were some of the incidents that made the list. I admit to cherry picking but this is my point. Don't just take the numbers and other bits of information at face value.
The CBC encourages us to question the motives of the device makers. The manufacturers may be driven by a need for profit. I suggest the CBC, and all news folk, should face questions as well. Journalists may have their own demons driving them forward. Think viewers, readers, awards and even think profits. I like to think it's the demand to tell a good story that blinds them.
So what were the surprising incidents that made the pacemaker incident list? Here are a few:
- patient piloting air ambulance involved in plane crash died. no evidence to support a device-related cause for the event.
- generator and associated leads were removed due to infection. source of infection unknown. patient died from liver cirrhosis.
- patient died due to acute coronary artery disease. device tested and functioned properly and within specification. patient was 85.
- pacemaker implanted for heart block. developed non-ischemic cardiomyopathy with ejection fraction diminishing. root cause was physiological.
Now maybe a good time to read the CBC fine print:
- CBC has not verified the accuracy of the data.
- Reports might have been filed to Health Canada with inaccurate or incomplete information.
- There is no certainty that the medical device caused the reported reaction.
- A given reaction may be the result of an underlying disease, process or another coincidental factor. One report may be tied to multiple parts of the same device and multiple reactions may be connected to a single patient.
The data does not reflect any CBC assessment of association between the health product and the reaction(s).
I'm on my second pacemaker. I got seven years out of my first unit before the battery failed. I apparently suffered no infection from the replacement surgery. My luck seems to be holding. But, I cannot be completely certain I escaped the threat of infection until a full year has passed.
My original lead, the 26-inch wire connecting my pacemaker to my heart, was retained and reused. It has now been operating in a very hostile environment, the human body, for eight years. How long that lead will last is anyone's guess. The electricity-conducting wire could corrode or succumb to metal fatigue. Leads do fail and the frequency increases with time. And, of course, there is always the threat of manufacturing defects and recalls.
Just living carries risks. I simply live with a few extra risks. But risks in life are often nicely balanced by rewards. I believe the risk/reward ratio associated with my pacemakers are weighted heavily in favour of my pacemakers.
Thank you Medtronic.
Despite the scary tone of some of the CBC reporting concerning pacemakers, the ICIJ stories, the source for the ongoing CBC reports, is often not as frightening. The ICIJ is actually fairly reasonable. The following is from the ICIJ report titled: Frequently asked questions and resources for readers.
Do all medical devices have problems?No. For example, pacemakers and implantable cardioverter defibrillators (ICDs) have revitalized and saved millions of lives.
I'm not keen on having man-made stuff implanted into my body. I've had car problems, microwave breakdowns and expensive camera battery failures. Stuff fails. It is a fact of life. Sadly, sometimes stuff fails because of poor design or shoddy workmanship. This is not acceptable in any situation but it is a worst case scenario when it involves the failure of a medical device. The ICIJ is doing us all a service.
The ICIJ asks who is watching the medical device makers? I wonder who is watching the journalists?
Sunday, November 4, 2018
|This opinion piece contains many questionable numbers. In the old days it would've been spiked.|
"Who's really endangered?" My answer may surprise you: Newspaper copy editors.
A quick reading of the opinion piece written by Elizabeth Nickson left me asking, "Where is a copy editors when you need one?" Copy editors are an important and respected part of every newsroom — or, at least, were in the not-so-distant past. These talented, well educated, team players fixed grammar, corrected spelling and checked both usage and style for agreement with the newspaper's in-house style guide. (This post would look quite different if I had a copy editor.)
Sadly, copy editors are a dying breed. Many have been given early retirement, their jobs declared redundant by the giant media conglomerate owners.
The opinion piece written by Elizabeth Nickson, a fellow at the right-wing Frontier Centre for Public Policy, often called a right-wing think tank, is a good example of writing in need of a skilled copy editor.
Nickson immediately stakes out the territory she is attempting to control: The sixth great extinction. "Unlike climate change, the notion of the sixth great extinction is not contested vigorously . . .," she claims, moving quickly to a full frontal attack on Paul Ehrlich, whom she derisively calls "the godfather of extinction science."
Unfortunately, it seems Nickson got her godfathers mixed and predictions as well. She tells us that Ehrlich predicted 27,000 extinction a day by 2000. He didn't. It was Edward Wilson, the father of sociobiology and a champion of biodiversity, who made that prediction, sort of. He predicted 27,000 extinction a year.
That's more than 70 a day, an amazingly high number until you understand the professor is talking about the destruction of the world's rainforests, the most biologically diverse places on Earth. He is not talking about black-tailed prairie dogs in the west or caribou in Canada's distant north. He does not restrict his prediction to large mammals and birds and this should come as no surprise; Wilson is the world’s leading authority on ants.
Ehrlich's and Wilson's ideas have attracted a lot of opposition over the years. It's a rich, complex world and, just as one would expect, not every biologist studying endangered species agrees with either man. Nickson would be in good company if her facts were correct but they aren't.
Nickson does no better reporting on the black-footed prairie dog situation in Colorado. Numbers are again the Frontier Centre writer's downfall. I won't go so far as to say Nickson is wrong but there is no doubt that her writing lacks clarity. People familiar with the situation in Colorado were puzzled by the Nickson numbers.
Tina Jackson, Species Conservation Coordinator with the Colorado Department of Natural Resources , wrote me, "I am not sure where they got that information about black-tailed prairie dogs in Colorado." Neither Jackson nor James Baker, also with the DNR, was aware of this ever being taken to court.
Elizabeth Nickson was good enough to share some of her research links with me for this article. Reading through the links, and links to links, she sent me I found the following:
The earliest published estimate of prairie dog occupied acreage in the state (Colorado) is from C.P. Gillette in 1919 . . . (Gillette believed) prairie dogs inhabit about 12 million acres in the State . . . [Is this the source of the 12 million number?]
A good editor will tell a newspaper writer to deliver the goods before the turn. Break a newspaper story into two parts and a large number of readers won't make the turn. Editors keep stories short, interesting and accurate.
Today, a great number of people are failing to even pick up the paper, let alone make it past the turn. If newspapers want to bring back the readers, bring back the copy editors.