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Tuesday , November 20 2018

‘Bleeding’ a disturbingly powerful film

Documentary takes a look at medical device industry

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.

Here’s the shocking fact. Near the end of “The Bleeding Edge,” a statement appears listing the corporations that produce medical devices — Johnson & Johnson, Bayer, and several others — that refused to be interviewed by the filmmakers. We’ve seen these sorts of statements many times at the end of documentaries; it’s standard operating procedure for corporations that want to cover up what they do. In this case, however, the list of powerful entities that stonewalled the filmmakers includes the FDA.

I don’t think I’ve seen that before in my life: a government agency, one that exists to protect consumers, refusing to even talk to established journalistic filmmakers. That’s how far, how openly, the Food and Drug Administration is now in the tank with the corporations it’s supposedly there to safeguard against. It’s a sign of how much the culture of corporate lobbying has broken down the walls; there is no longer even a pretense of lawmakers acting independently of them. And that — maybe more than the rise of Donald Trump — is the real change in America. That’s why our government no longer works.

“The Bleeding Edge” is about that paradigm-shifting corruption of the American system, but it roots its critique in an intimate look at the lives and medical complications of ordinary folks who’d put their faith in their physicians, only to emerge betrayed. The movie is organized around a handful of devices that were shown to be harmful (and only perfunctorily tested), and in each case the symptoms caused by the device are even more hellish than the symptoms in the case before it.

That’s no accident. Kirby Dick, director of the Oscar-nominated “Twist of Faith” (2005) and “The Invisible War” (2012), as well as “The Hunting Ground” (2015), “This Film Is Not Yet Rated” (2006), and — one of the most memorable documentaries of its time — “Sick: The Life and Death of Bob Flanagan, Supermasochist” (1997), is a deadly earnest but instinctively dramatic filmmaker.

Spins

Working alongside his producing partner Amy Ziering, Dick has conceived “The Bleeding Edge” as a kind of true-life sci-fi horror film that spins around the queasy theme of invasiveness. Think “Frontline” meets David Cronenberg.

The first device the film deals with is hip replacements, and the irony here is that the technology of 30 to 40 years ago worked terrifically well. But there was no profit — or not enough profit — in just churning out those devices. In America, “new and improved” is what sells. In this case, that meant hip replacements made of cobalt, which sounds like something out of a $6 billion cyborg-superhero movie. (He’s human, but with indestructible cobalt limbs!) The trouble is, the hip replacements began to leak cobalt into people’s bodies, causing all sorts of breakdowns, both physical and mental. We hear about this through the eyes of Dr Stephen Tower, an Anchorage orthopedic surgeon who got a cobalt hip replacement and began to fall apart.

Was the device tested? Yes, but in a nominal way. The movie sketches in the corner-cutting regulations that are now built into the FDA’s Premarket Approval or (even worse) 510(k) Clearance processes, where a device can pass muster, with next to no testing, if the company selling it claims that it’s “substantially equivalent” to a product that has already been approved. There’s one provision in all this that’s so corrupt it’s mind-boggling: Even if the previous product has been pulled off the market for safety reasons, as long as the new product is deemed to be just like it, it can still win approval. Yes, that makes no sense, and yes, it leads to unspeakable nightmares.

The saga of the cobalt hip replacement is merely the prelude to the central horror story of “The Bleeding Edge”: how the Essure insert, a non-hormonal birth-control device for women, was marketed by Bayer, and approved by the FDA, in the face of evidence that it could cause egregious damage. Even the way that the Essure device is designed to work is creepy. It’s a small coil that gets inserted into the fallopian tubes, causing scar tissue and permanent blockage. But the symptoms, it turns out, didn’t end with sterilization. The device frequently caused intense, destabilizing physical distress, crippling the lives of many of the women who used it. What’s more, there was no way to remove it without leaving fragments of metal, which continued to cause the same problems.

Also:

LOS ANGELES: Bayer lashed out at Netflix documentary “The Bleeding Edge,” with the pharmaceutical giant saying it presents an inaccurate picture of its Essure birth-control implant device.

The film from Oscar-nominated documentary filmmakers Kirby Dick and Amy Ziering (“The Invisible War,” “The Hunting Ground”) takes a look at the medical-device industry, “examining lax regulations, corporate cover-ups, and profit-driven incentives that put patients at risk daily,” according to a Netflix description.

Bayer, in a statement issued Friday, said the film “presents an inaccurate and misleading picture of Essure by relying almost entirely on anecdotes, cherry-picking information to fit a predetermined conclusion, ignoring the full body of scientific evidence that supports the determination that Essure’s benefits outweigh its risks and disregarding the appropriate warnings that accompany the device.” (RTRS)

Netflix reps did not respond to a request for comment.

Bayer currently faces more than 16,000 lawsuits in the US related to Essure by women who claim the implants caused injuries such as excessive bleeding, abdominal pain and allergic reactions, according to the New York Times.

Last week, Bayer announced that it would discontinue sales and distribution of Essure in the US at the end of the year. The company cited declining interest in Essure among women, which it attributed to factors including decreased use of permanent contraception overall, as well as negative publicity about the device including the accounts in “The Bleeding Edge.”

“The Bleeding Edge” launched on Netflix on Friday (July 27). Bayer said its critique of the film is based on a review of the film’s premiere at the Tribeca Film Festival in April.

According to Bayer, the company provided the producers of “Bleeding Edge” with “extensive scientific information on Essure before the completion of the film.” The pharma giant also alleged that several sources interviewed for the film have potential conflicts of interest that are not disclosed. The movie “does a disservice to the thousands of women who rely on Essure for their reproductive health, as it may encourage them to pursue risky and unnecessary surgery to remove the device,” Bayer said.

Essure was approved under FDA’s Premarket Approval program for medical devices in 2002. (RTRS)

By Owen Gleiberman

 

 

 

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