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Saturday, July 28, 2018

BioMed Sector: the Bleeding Edge

My wife alerted me to this.

"What you don't know, can hurt you. From the Academy Award® nominated filmmakers Kirby Dick and Amy Ziering (The Invisible War, The Hunting Ground) comes a groundbreaking investigation into the crimes of Big Medical. America has the most technologically advanced health care system in the world, yet medical interventions have become the third leading cause of death, and the overwhelming majority of high-risk implanted devices never require a single clinical trial."
Film Review: ‘The Bleeding Edge’
Kirby Dick's disturbingly powerful exposé of the medical-device industry nails a corporatized America that has stopped taking care of its citizens.

If you watch enough passionate muckraking social-justice documentaries, or simply listen to the news every day, you may feel like you’ve lost the capacity to be shocked. But “The Bleeding Edge,” Kirby Dick’s disturbingly powerful and important documentary about the medical-device industry, contains a line near the end that truly shocked me, because it defines, with a word (in fact, three little letters), what’s happened to America.

The movie is about an industry that now generates revenues of $300 billion a year by producing and marketing the highly sophisticated utensils and apparatuses that get implanted into people’s bodies. (Over the last decade, 70 million Americans have been outfitted with internal medical devices.) It’s also about the scandalous and clandestine inhumanity of those companies. There are, of course, many devices that save lives and vastly uplift people’s daily welfare: pacemakers, hip replacements, cornea transplants.

The film doesn’t deny any of this; it never paints its indictment with a broad brush. But it focuses on a handful of devices that have caused toxic levels of harm to the trusting victims who’ve used them, and the scandal — which is ongoing — is that the devices were never properly tested. In essence, the corporations put them out there and said, “What the hell, let’s give this a try!” The people who used the devices became human guinea pigs (just like the women who took thalidomide in the late 1950s), and when they began to develop symptoms of harm, they had no idea what was happening to them. Even when they started to figure out the source of their symptoms, there was little or no recourse and (in many cases) no way to reverse the damage…
Interesting. About a month hence I will be the SAVR px recipient of a biomedical device, a prosthetic bovine aortic valve.

I recently finished watching the moving HBO documentary on the late Robin Williams ("Come inside my mind"). I'd not been aware that he'd had a SAVR:

What a terrible loss.

I never got to meet him. That would have been so cool. We have a mutual connection.

We have NetFlix here, will have to pull up The Bleeding Edge and watch it. Stay tuned.


We pulled The Bleeding Edge up on NetFlix and watched it in its entirety in rapt attention. It is a must-see.

Compelling. Infuriating.

Again, a must-see documentary. Below, from the website:
The Facts in The Bleeding Edge

The medical device industry has responded to the malfeasance exposed in our investigative documentary The Bleeding Edge.

Here are the facts:

The facts set forth in The Bleeding Edge are accurate and have been rigorously vetted by extensive research and multiple experts.

Bayer claims the portrayal of its harmful birth control device Essure in The Bleeding Edge “lacks scientific support” and is “inaccurate and misleading.” These claims are false.

The truth is that Essure was approved under an “expedited review” without randomized, nonblinded studies or a comparator group. These studies followed most participants for only 18 months, even though Essure is supposed to remain implanted for a woman’s lifetime. Some of the patient forms in the Essure studies were altered to reflect a more positive outcome than what was reported by the patient. Conceptus, the original manufacturer of Essure purchased by Bayer, hid more than 32,000 adverse events regarding Essure from the FDA.

Bayer’s attacks on three of the experts in The Bleeding Edge are without substance. There are no conflicts of interest regarding any of the experts in our film.

Dr. Diana Zuckerman is president of the non-profit National Center for Health Research (NCRH.) As an expert witness discussing her survey of Essure patients, she requested that the plaintiff’s attorney pay $375 to the NCRH. This represents no conflict because she says nothing about Essure in the film. Dr. Zuckerman has been quoted in the New York Times, the Washington Post and other media describing the need for well-designed, long-term research on Essure.

Dr. Julio Novoa is an experienced OB-GYN who surgically removes Essure from women who have been harmed by the device. For Bayer to suggest that he has “a financial interest in recommending the removal of the product” because he is being paid for doing his job is both cynical and false. Madris Tomes, a former public health analyst for the FDA, provides FDA public data and trends of adverse event reports to clients. Tomes has provided data expertise to the Essure Problems Facebook group pro bono.

On July 20, one week before The Bleeding Edge was released on Netflix, Bayer announced it would stop selling Essure after 2018.

In response to the film, Johnson & Johnson stated “providing safe and effective products is always our top priority.” This is contradicted by the fact that they released cobalt metal-on-metal hips as well as pelvic mesh despite knowing that there were significant safety risks with both.

Court records show that in 1995 a scientist from DePuy, whose parent company is J&J, warned about the dangers of their cobalt metal hip. After it was put on the market, surgeons, researchers and health officials repeatedly informed J&J that their hip device was harming patients, but it wasn’t until 2010 that J&J finally recalled the product, after it harmed tens of thousands of people.

Additionally, court records show that J&J also knew their pelvic mesh would injure women, but J&J chose to put the device on the market anyway. There are now tens of thousands of lawsuits filed against them by women harmed by mesh.

In response to the film, the FDA stated, “Often the true benefit-risk profile of a device cannot be fully understood until it can be evaluated when used in routine clinical practice.” This is far too late. To protect Americans, the FDA must establish that a device is safe before it is put on the market.
The FDA claims that it has taken “many steps” in recent years regarding Essure, but the FDA never took the most important step: recalling this flawed and dangerous device from the market in the U.S., especially after it had been taken off the market in the rest of the world.
The FDA, Bayer, Johnson & Johnson all declined to be interviewed for the film.

From The Union of Concerned Scientists:
Drug and Medical Device Companies Have Outsized Influence on FDA
$700 million in lobbying buys significant access

As Congress decides the influence that pharmaceutical, biotech and medical device companies should have over the Food and Drug Administration (FDA), industry spends big.

Data compiled by the Center for Responsive Politics and commissioned by the Union of Concerned Scientists show that between 2009 and 2011, prescription drug, biotechnology and medical device companies spent more than $700 million lobbying Congress and the Obama administration.

That’s a lot of money. By comparison, the insurance industry spent $480 million in the same period. Drug companies alone spent more than $487 million on lobbying during the three-year period; biotechnology and medical device companies spent $126 million and $86 million, respectively.

Over the same period, elected officials on a House subcommittee and a Senate committee with oversight over FDA received nearly $6.3 million in campaign contributions from these industries. Donations went to both Republicans and Democrats.

Explore the major findings from our investigation and see all of the data we relied upon…
In a recent book review post, "Overcharged: paying for health care," we looked at U.S. exorbitant cost issues. Here's an excerpt from the book:
“How Could a Medical Device Be So Well Accepted Without Any Evidence of Efficacy?” We offer three reasons. First, doctors had a theory suggesting that the filters should work. Second, once the practice of using filters gained a following, doctors simply “assumed that there was strong evidence for their use.” Why else would so many doctors have put so many filters in so many patients? Third, Medicare, Medicaid, and other payers covered the procedures. In hospital settings, Medicare paid $3,300 for filter insertion, $2,600 for filter repositioning, and $2,600 for filter removal. When these procedures were performed in a doctor’s office, the fees were $2,800, $1,800, and $1,750, respectively. Treatment patterns got well ahead of the science. When the science finally caught up, there was a large financial incentive not to reverse course.

AUCs and other professional guidelines are pointless unless they limit practitioners’ discretion and prevent them from recommending aggressive treatments too often. The tendency to overprescribe reflects a confluence of factors: physicians’ strong desire to help, their belief in the efficacy of their tools, and, of course, the strong financial incentive to perform procedures. As Dr. Redberg put it when discussing the epidemic of overstenting, “It’s like asking a barber if you need a haircut. To an interventional cardiologist, stents are good for almost everyone.”

Charles Silver & David A. Hyman. Overcharged: Why Americans Pay Too Much for Health Care (Kindle Locations 2340-2351). CATO Institute.
Interesting. BTW, searching "FDA" in the book netted 87 hits, nearly all of the textual references using the acronym critical.


THE Health IT event of the year.

Saw news that Alan Alda has gone public with his having Parkinson's. He remains unfazed, and continues with great work (that I have to sheepishly admit to not having been aware of).

"The Alan Alda Center for Communicating Science empowers scientists and health professionals to communicate complex topics in clear, vivid, and engaging ways; leading to improved understanding by the public, media, patients, elected officials, and others outside of their own discipline..."
I registered. This is important stuff.

More in a forthcoming post. For now, relatedly, see my prior post "A case for interdisciplinary science."

More to come...

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