Month: June 2019

HBO and John Oliver want to destroy the medical device industry to help you

I do not watch Last Week Tonight because it is HBO’s hyper-biased version of the Daily Show, hosted by former Daily Show jagoff, John Oliver.

I was alerted to the segment that ran on Sunday night and when I watched it, it nearly gave me a fucking stroke.

Understand this was my life for almost a decade.

I earned my masters and doctorate in projects related to orthopedic implant design and manufacture.  My graduate advisor and mentor had previously been the chief metallurgist of the medical device company Zimmer in Warsaw, Indiana.

I went to work for a consulting company to do medical device failure analysis and actually worked on the DePuy Synthese ASR case.

I was patent pending on two medical devices until I ran out of money to continue the application.

My dad’s law firm specialized in regulatory compliance and I did 510(k) reviews for his firm.

And with all the technical knowledge and authority that I have, what John Oliver says is fear-inducing, panicky horseshit that will help nobody and destroy the medical device industry around the world.

First of all, I found the original article he quoted on the 80,000 deaths figure.

Medical devices for pain, other conditions have caused more than 80,000 deaths since 2008

The media partners found that, across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the FDA over the last decade.

That sounds bad, but here is the caveat that John Oliver didn’t point out.

Although there are roughly 4,000 types of medical devices in the FDA’’ data, just six of them accounted for roughly a quarter of device injury reports since 2008. Spinal cord stimulators — which are implanted in 50,000-60,000 people a year — are the third-most reported device for injuries.

Oh, well gee.  So most of the 4,000 FDA cleared devices are perfectly good, only a tiny percent have real issues.

The way this data was presented was that at any moment your insulin pump or pacemaker could fail and it’s all because the implant manufacturers are a bunch of lazy, greedy bastards.

The article this was pulled from was a tearjerker about people who suffered from spinal cord stimulator for pain blocking.

I am familiar with this kind of device.  It is intended for pain management in severe cases that do not respond to any other treatment.

I am not victim blaming here, but the patient who received these devices, or at least those these devices are intended for, are already incapacitated by chronic pain or are doped into incapacitation on opiates.  So we are already dealing with less than optimal patient conditions in a patient.

This gets even more complicated.  I published a paper on medical device failure for fracture fixation devices.  I have been an expert in medical device failure in spinal fusions.

Quite frequently device failure is blamed on the device and not the patient.  Here’s something you are not often told, there is no fixation plate that is strong enough to hold you together forever.  None.  They are not designed to be permanently load bearing.  Your bone needs to heal.  If your bones do not heal, the fracture plate and screws will fail in fatigue.  You have about 30 days.

Spinal fusion rods are the same.  If your vertebrae do not fuse in 60 days, your rods will fail.  There is not enough room in your body to make a rod thick enough and strong enough to be permanently load bearing.

The primary cause of hip implant failure is loosening on the proximal end of the femur due to bone resorption from a poor fit.  If this happens, blame the surgeon or osteoporosis.

Restenosis is the re-narrowing of an artery after the implant of a stent.  It is also considered a device failure.  It can happen to just about any patient.  Inflammation of the artery wall can stimulate more plaque build-up, there are some drug-eluting stents that can hold the inflammation at bay for a while but once all the drug is gone, it can happen.

I could do this all day, go through what are listed at device failures that are not the result of a defect in the design or manufacture of the device.

Medical device design is ridiculously difficult.  It’s worse than aerospace.  You can only operate within a narrow margin of safety.  You can’t just make a part thicker or bigger to reduce stress because it still needs to fit inside of a person.  You are dimension constrained by being able to fit into the bone or under the skin or in a vein or artery.

Your material selection is limited by what does not cause a negative reaction in the body.  Pretty much you are limited to polyethylene, Teflon, titanium, cobalt-chrome (Satellite), and some austenitic stainless steels, but the industry is trying to get away from that because of issues with nickel.  There are some very special alloys that are used in very limits applications like zirconium or platinum for electrodes but not in bulk devices.

So the suggestion that all of the deaths and injuries of device failure is directly the result of devices being bad is just flat fucking wrong.

But onto the bulk of John Oliver’s bullshit.

The Pre-market Notification of Approval or 510(k) is not a loophole.

This is the same bullshit we see when it comes to Lefties talking about guns or some right guy not paying enough in taxes where “everything I don’t like is a loophole.”

It’s a system set up by the FDA that allows medical device manufacturers to piggyback on prior approved devices to get products to market faster and cheaper.  To do that, a 510(k) device needs to show “substantial equivalence” not “substantial similarity” (that fuck-nut couldn’t get that right either) to existing items.

What does this mean for practical purposes?

That allows companies to make iterative design changes and improvements without having to spend five years and a billion dollars doing clinical trials.

The benefit is that it allows smaller companies and startups to come in and innovate without the need for capital and time that a clinical trial requires.  A lot of medical device design starts this way.  Especially in orthopedics, where some surgeon has an idea from 20 years of practice and works with an engineer to make a device, get the 510(k) and then sell out to a major biotech company.  I’ve known more than a few guys like this.

(If you are an orthopedic surgeon with an idea, I’m here to help, just email me)

Without the 510(k) process, every design change would be bank-breakingly difficult to bring to market and would be unreasonably expensive if it made it there at all.  Eliminating “the 510(k) loophole” would pretty much kill medical device R&D.

John Oliver can be a smarmy little fuck about DePuy wanting to make money off this device and the party that they threw, but I know guys at DePuy and I will say the same thing about them that I say about the people I know in the gun industry.  They are good engineers who do a job they are passionate about.  They want to help people.  The idea that they are just a bunch of unethical monsters who don’t care that people get hurt for the bottom line is ugly and wrong.

One of the reasons I stopped watching John Oliver or Adam Ruins Everything isn’t just because Adam Conover looks like he gels his hair with jizz, but because I am sick and fucking tired of the conspiratorial nature of these shows, i.e.:

Never trust the company out to make a buck.  They are always lying and cheating.  But me the intrepid journalist with a message to push and who makes money from views is honest and only looking out for your best interests.  Also that bureaucrats are our friends who only exist to make the world safer from those evil corporations.  

What I can tell you about the DePuy ASR case is that there may have been some design aspects that probably should have gone through more clinical trials, but there was also an issue with surgeons not putting them in correctly that severely exacerbated the problems with the design.

Furthermore, the ASR was designed to replace a worse problem.

Surgeons were putting artificial hips into younger and younger patients.  Some guy with a hip twinge at 62 would get a hip so he could play 18 holes of golf.  This was far beyond the design constraints of older metal or UHMWPE hips.  The ceramic on ceramic hips had a fatal flaw that they were not as shock resistant and the ceramic acetabular cup could shatter.

Cobalt-chrome on cobalt-chrome was hard, wear resistant, and shock resistant.  It was supposed to outlast the plastic cups with a range of motion that younger patients wanted.  Unfortunately, there were problems.

This is a far cry from the way that John Oliver portrayed the ASR release.

The end of the segment was the worst fucking thing I’ve ever seen.

“The FDA companies is up medical device manufacturers’ asses.”

Yes, they lobby to keep regulations at bay.  They do so because there are fuck-holes like John Oliver who would regulate the industry out of existence.  The 510(k) system exists to ease innovation, which more and more only comes out of the United States because the rest of the world has regulated their medical device industries out of the R&D market.

“Manufacturers are getting rich.  Doctors are getting rich.”

So the fuck what?  Good products are being created.  Patients are getting the devices they need.  Quality of life is being improved.

HBO is getting rich bullshitting you.  That is actually worse.

“And patients are getting their insides turned into oil and cheese.”

This is a rare mistake.  The vast majority of devices don’t have issues and a lot of problems are the result of compound causes, not just a bad device.

We already hear too many complaints about the cost of drugs.  Much of that comes from the same source, the almost unbearable cost of regulatory compliance.  Now these shit-for-brains want to cripple the medical device market with the same regulatory costs.

I cannot fathom the thought process that goes on in their heads?  Do they understand what the outcome is for what they want?

Well, no new medical devices have been released in years.  A few medical device companies have gone out of business.  Patents are having to use the same older, less effective designs that have been around for decades.  But at least nobody was hurt by a new device that went through the 510(k) ‘loophole’ and doctors stopped becoming millionaires from R&D.”

John Oliver is fear mongering about things he doesn’t understand with a grotesque bias.  He is little more than HBO’s Wesley Mouch.

Democrat Antisemitism Watch of the Day, June 3rd

This from Fox News:

California Dems propose resolution linking Israeli government to anti-Semitism, Pittsburgh synagogue massacre

Of course they do.  The Left loves to victim blame any group that isn’t part of their collective.

A draft resolution set to be debated this weekend at the California Democratic Party State Convention, obtained by Fox News, accuses the Israeli government of willfully “aligning with the virulent Islamophobia” of white supremacist groups in the U.S. — and links Israel indirectly to the Oct. 2018 massacre of 11 congregants at a Pittsburgh synagogue.

I mean, it’s not like the Islamic world hasn’t sworn to and isn’t actively trying to
“wipe Israel off the map” and “drive the Jews into the sea.”

The document was one of a slew of secretive, unpublished proposals obtained by Fox News that are slated for debate beginning Friday morning. 

Some of the draft resolutions would mandate that Democrat officials work to “nullify” President Trump’s pro-Israel policies. One document directs party officials to take a subsidized trip to Israel only “if they undertake to devote an equal amount of time to visiting Palestinian towns, villages and refugee camps in Israel and the occupied Palestinian territories.”

That almost seems like a suicide mission for any Jewish Democrat.

Tentatively titled “Commending the House for resolving to fight all racism and bigotry and for resisting the false conflation of support for Palestinian rights with antisemitism,” the resolution blasting Israel’s purported role in furthering white supremacy was co-authored by David Mandel, an elected state Assembly delegate and progressive attorney who says he holds dual U.S.-Israel citizenship and lived in Israel for 10 years.

There is no Jew hatred like the self-hatred of a Lefty Jew.

Support for Palestinian rights isn’t antisemitism.  Accusing Israel of genocide or supporting Palestinian terrorism is antisemitism and that line is crossed all the time by Palestinian rights’ activists.

The document calls the October synagogue shooting “the culmination of an alarming re-emergence of virulent antisemitism that is a core element of historical and currently resurgent white supremacism in the United States and around the world.” The “Israeli government, along with some of its U.S. backers,” the resolution continues, “welcomed support from Christian fundamentalist and ultra-right groups in the United States and abroad, dangerously ignoring their deeply rooted antisemitism while aligning with their virulent Islamophobia.”

Those Israelis trying to combat Islamic violence and terrorist fundraising were just so happy to jump into bed with Neo-Nazis.

If you believe that you should go play Russian Roulette with a semi-auto.

Speaking to Fox News, Mandel said it would be “far-fetched” to say that the resolution “directly” blames Israel for violence against Jews. But, he suggested, Israel officials did bear some indirect responsibility for both anti-Semitic and Islamophobic violence.

“The Israeli government and its supporters here seem to be embracing the right-wing and not caring what they say about anything else — Islamophobia, dog whistles for anti-Semitism,” Mandel said. “That, I think, does indirectly lead to some of the violence.”

Mandel added: “What we’re saying is the Israeli government is aligning itself with right-wing governments around the world, including in this country, and those right-wing groups — a core tenet of their ideology is antisemitism.”

What did I just say about Lefty self-hating Jews?

And didn’t I just write a post about the antisemitism of a bunch of anti-Klan Lefty protesters on the side of Palestinian rights?

Since the Republican party is the only of the two major American parties that openly supports Israel and unconditionally condemns antisemitism right now, I don’t think this guy has much of a “the Right Wing is bad” leg to stand on.

The resolution, like several others, will quickly go before a Resolutions Committee, which largely has control of which resolutions are adopted and debated.

“Most of the 3,000 or 4,000 delegates at the convention will agree with us,” Mandel said, “but that doesn’t mean we’re going to succeed in passing the resolution.”

Good to know the majority of Democrat delegates have an antisemitic streak.

On Saturday, after this article was published, Mandel told Fox News that the Resolutions Committee had rewritten the resolutions, without the consent of the original co-authors, and then passed those revised resolutions under the original co-authors’ names. Mandel called the process “outrageous” and a “perversion,” and said he was considering next steps.

Stabbed in the back by his Lefty Jew-hating colleagues?

Where have I seen that before?  I wonder if it was done at night, with long knives?

Coming from a party in which the old guard was hammered for trying to condemn the antisemitism within its ranks, seeing it embrace victim blaming Jew-hatred toward Israel shouldn’t surprise him.  It doesn’t surprise me.

It’s not Trump but this bullshit that will make violence against Jews worse.

It is the justification currently used in Europe to excuse Muslim attacks on Jews.

Now when another violent attack happens to Jews in the US, the official Democrat position will be “this is Israel’s fault.”

 

 

 

 

The other side of the Klan coin

Almost two years ago I wrote a post about an internet meme in which I said the groups protesting each other, Neo-Nazis, Antifa, and BLM, were just a diversity of Nazis because they all borrowed from the same racial identitarian politics and were all Jew haters.

Two years later, they had the chance to prove my point again.

The Honorable Sacred Knights of the Ku Klux Klan decided to have a rally in Dayton, Ohio.

Nine Klansmen showed up.  Nine.  Whoop-dee-fuckin’-doo.

Some six hundred protesters showed up challenge the Klan.

If you were to think “hey, that’s great, that’s a 66:1 ratio of people who are against racism and hatred versus people who are for racism and hatred” you forget who makes up the Left these days.

NO VIOLENCE OR ARRESTS AT KLAN RALLY IN DAYTON, COUNTERPROTESTERS DESTROY ISRAELI FLAG

Guess who was destroying the flag?

Hint: not the guys with the white robes.

When Stathes learned of the rally, she decided to hold a fundraiser; The Barrel House donated a dollar per pint sold on May 25 to the National Conference for Community and Justice of Greater Dayton. After she posted the fundraiser on Facebook, two local businesses each matched the dollar per pint.

“People came out strong to support that,” Stathes said.

That afternoon, someone posted a series of photos on her Facebook site showing people in the counterprotest area first attempting to burn an Israeli flag, then tearing it and stomping on it.

“I was shocked to see that,” Stathes said. “I saw some counterarguments (in the comments) as to why they might have done that, but at the same time it’s totally unacceptable. It made me feel sick.”

Welcome to the reality of Social Justice.

According to Stephanie Hausner, deputy director of the Israel Action Network of Jewish Federations of North America, Students for Justice in Palestine equates Zionists and the KKK as fascists.

Native American rights activist Corine Fairbanks of Dayton took the series of photos, which have been widely circulated on social media. Fairbanks posted them at her Facebook page just before the end of the rally and counterrally, with the heading: “More Allies, and Palestinian Relatives, wanting to burn flag – FREE PALESTINE!! Deport the KKK.”

I saw a lot of this in South Dakota.  Some of the worst Jew haters were Native Americans who had never met a Jew but were sucked into Leftist activism and equated the Palestinians with Indians and Jews with white settlers.

Jen Mendoza, with the Cincinnati Palestine Solidarity Coalition, is a friend of Fairbanks. Mendoza is shown in the images wearing sunglasses and attempting to set the Israeli flag on fire with a cigarette lighter.

In an interview with The Observer, Mendoza said the incident occurred after she saw three young men with an Israeli flag and entered into what she described as a confusing discussion with them.

“And so recognizing the state of Israel as being of the same ideology (as) American capitalist imperialist settler colonialism, and seeing that flag on our side (counterprotesters area) was jolting,” Mendoza said of her reaction at the sight of the Israeli flag.

Because the Left is made up of ideological purists who will not tolerate any other viewpoint and will respond to one with violence, but they are not the fascists.

“One of them said that he was from Israel. And then the other two boys looked Arab,” she added. “The other kid, he was the one doing a lot of the talking, he made comments about God giving them the land, and at that point I was like, ‘Well, you’re on the wrong side of this fence if that’s what you believe.’”

Does that apply to all religions or ancestral claims or are only the Jews wrong?

Mendoza said that after the conversation went on and he said “some extremely Zionist, racist things,” he asked her if he should throw it on the ground and stomp on it.

She told him she’d be happy to burn it for him.

“And then he flipped and was like, ‘Yeah, let’s burn this flag right now,’” Mendoza added, “and he helped tear it apart — and then he told us that he was doing a social experiment to find out where people really stood on fascism. And then he began chanting ‘Free Palestine.’”

I’m pretty sure taking someone else’s flag then burning it because you don’t like what they believe is … what’s the word … fascist.

Fairbanks said that a young woman in the crowd started yelling at those destroying the flag, saying, “What are you? Against Jews?”

“And I remember them (the young men) saying that no, they weren’t against Jews, they wanted Palestine to be free,” Fairbanks said.

No, they hate Jews, but they know saying so isn’t popular.

Fairbanks said she responded along with others that “No one’s against anyone except for colonial imperialism.”

And that is the excuse they use to justify driving the Jews out of a place they have lived for over 5,000 years.

“I’m American Indian,” she said. “To say I’m against America and the United States government and what they’ve done to indigenous people, yes definitely. So I am in solidarity with indigenous people worldwide. I know there’s a complex history with the indigenous people and what’s happening in Israel, I understand there’s a complexity that’s very different from what’s happening here, but there’s also a lot of commonality between Native American people here and the indigenous people there.”

She doesn’t understand shit.

Fairbanks added that the flag of the state of Israel “has nothing to do with Judaism.”

That is their cover.

Israel exists as a sovereign homeland for the Jewish people.  To deny Jews self-determination in a sovereign homeland is antisemitism, but if they argue that Israel has nothing to do with Judaism, suddenly they are on the moral high-ground.

A rally of nine white supremacists brings out an even larger number of Jew-hating Leftists.

the Left shows us who they are more and more every day, I just don’t understand why so few Jews believe them.

Scene from the California Democrat convention

This past weeken was the California Democrat Party convention.

One of the two dozen clowns running for President, Colorado Governor John Hickenlooper, gave a speech to uproarious booing.

What did he say?

Socialism is not the future of the United States.

https://m.youtube.com/watch?v=GOdNC55ROLQ

Yep, that is the status of California Democrats.

The want full Socialism in America and they are not going to tolerate anyone to the right of Hugo Chavez telling them otherwise.