Bleeding Edge: Q&A with Director Kirby Dick and Producer Amy Ziering
By Annette Graham, DC Film Society Member
A screening of The Bleeding Edge was held at AMC's Georgetown Theater on July 24. Present for discussion were the film's director, Kirby Dick, and producer Amy Ziering.
The Bleeding Edge is a documentary about the dangers of the $400 billion medical device industry. Devices are routinely implanted in patients without a single clinical trial on humans thanks to the FDA's 501 (k)--Premarket Approval process (PMA) which states that a device can evade scrutiny if it is "substantially equivalent" to another on the market. Five medical devices are discussed through interviews with the patient/victims, among them are Essure, a birth control device, a pelvic mesh implant and metal-on-metal hip replacement. Bayer, maker of the Essure implant, has already announced that their device will be taken off the market.
Among the filmmakers' previous films are This Film Is Not Yet Rated (2006) about the secretive movie rating system, The Invisible War (2012) about rape in the military and The Hunting Ground (2105) about sexual assault on college campuses. This Q&A has been edited and condensed.
Moderator: How did you get involved in this story?
Kirby Dick: We got involved in this when we learned that the FDA doesn't require any clinical testing on humans. We are known for investigating stories that are important but that few people know about. We had never heard of this. We started asking around. It turned out that few people knew that most of that risk is devices, not just in or on humans. The FDA doesn't require clinical trials with humans before they are put out onto the market. That was such an astonishing fact. We looked deeper and deeper into this and realized that this is an industry that has been able to operate under the radar; it's much less regulated than pharmaceuticals and there are really hundreds of thousands if not millions of people who have been harmed by medical devices. There is so little reporting about this. We felt it was really important to look into this story.
Moderator: What do you hope will be the outcome of producing this film?
Amy Ziering: We want a better system, federal regulation and for people to ask questions if they have a device put into them, and save lives. We want Congress not to be at the bidding of corporations and their desires.
Moderator: One thing that struck me is that besides the FDA there is a gatekeeper between the medical devices and agent and that's the doctor, someone who most patients trust and rely on to provide them with advice that they themselves are not capable of knowing. In making the film you talked to a number of doctors. What was your sense of how many of them were aware of the risk-benefit tradeoff of the devices they provide to the patients? Were they properly conveying to the patient when they make a recommendation, not just the benefits but possible things that could go wrong? That seems to be a thread in many of these women's stories. They are told of the upside of the procedure but had very little knowledge of what could possibly go wrong.
Kirby Dick: Most doctors we encountered, and I think it's true across the country, really want to do the right thing. But in many ways doctors are victims here too. They are getting misinformation from the medical device companies. The substantial majority of the research they rely on is funded by the medical device companies and it's been shown that studies funded by medical device companies are, not surprisingly, biased in favor of the medical device companies. And the other thing that is really shocking, that we learned when we got deeper into this, is that it seems this is not taught in medical schools. The regulatory system and how medical devices are regulated does not seem to be taught in medical schools. So these doctors have no idea how these devices they are putting in patients are regulated and they don't know that they haven't been tested on humans. This film is obviously made for the public and made for policy makers but also made for doctors. Doctors who have seen the film have thanked us repeatedly. We've heard from dozens and dozens of doctors. It's been an incredible response.
Moderator: This is a complicated issue. How did you make a film about a very scientific issue, plus regulation, and make it accessible for the average American?
Kirby Dick: We started by letting the patients--the survivors and victims--tell their story, because those stories are not heard. Our interviewer was able to get very very powerful responses from these subjects. We've done that before. The best way to tell a story is by hearing from those affected.
Amy Ziering: This was the hardest movie we have ever made. How do you simplify it but not dumb it down and do a disservice? How do you still make it compelling but not make it boring so that people get lost. We've worked together on a lot of films as a team. You learn from each film, what is most effective, how to narrate, present characters they can sympathize with and identify with and feed the audience scientifically accurate information throughout. So you are not just getting research information, you are getting a story and learning at the same time. We've figured out how to do this and keep it going--keep them informed, enlightened and moved. That's what we are trying to do, not just lecture you, but have you learn, and care and be moved to change.
Moderator: Bayer announced that it's going to stop marketing Essure in the US (audience claps).
Amy Ziering: It's news that happened because of the film. The film came out in April at the Tribeca Film Festival. There was a lot of talk about it. I hope it authors changes all the way down the line, not just medical devices.
Audience Question: Should section 510K be repealed? Is there a good reason why so many victims in your movie were women? Can we get that list of advice you gave at the end?
Amy Ziering: The list is on our website. The film is coming out this Friday.
Kirby Dick: In 2011 the National Academy of Sciences did a very comprehensive review of 510K trying to figure out how it can be improved. In the end, it said you would have to start from scratch. The first place we should start is making sure that devices are required to be tested.
Amy Ziering: Men and women are equally at risk due to a system that is poorly regulated and profits are chased. However, women are to a greater number disproportionately affected due to gender bias. It wasn't our intention. I don't want people to think that medical devices for men are okay. That's not the case. It's a problem across the board. Just because of the time and space, there are only a certain number of stories you can tell; it just lined up that the devices we profiled affected more women.
Audience Question: Have you done a congressional screening for members of Congress and staff? What kind of response did you get from both sides?
Kirby Dick: We are planning a screening on the Hill. A few members of congress and staff have seen it--not a lot have seen it, the film is just coming out--but they were moved by the film. This is not a partisan issue; obviously this issue affects everyone. Congess oversees the FDA, and passes laws to regulate it. For the most part, Democrats and Republicans have been equally influenced by the medical device industry. Both parties are involved.
Audience Question: Why are manufacturers putting out untested products?
Kirby Dick: For the most part we saw this across the industry, because they were allowed to get away with it, they would do it. As we saw in the film, Johnson and Johnson was aware of the problem before they put it on the market. They made a financial decision to go ahead and put it on the market, by the time people found out, they would have made a profit, even if there were lawsuits. The penalties they paid was just a small amount of the profits made. People didn't figure this out until later, there was a time lag, statute of limitations, etc. They are still up by millions.
The Bleeding Edge opens in theaters and launches on Netflix on July 27.
Calendar of Events
FILMS
American Film Institute Silver Theater
"Ingmar Bergman Centennial" (July 10-September 13). Titles in August are All These Women (1964), Autumn Sonata (1978), Cries and Whispers (1972), Face to Face (1976), From the Life of the Marionettes (1980), Hour of the Wolf (1967), The Magic Flute (1975), The Passion of Anna (1969), The Rite (1969), The Serpent's Egg (1977), Same (1968), The Touch (1971), and Scenes from a Marriage I and II (1974). More in September and more at the National Gallery of Art.
"Canada Now" (July 16-September 3) is a festival of new films from Canada. Titles in August are Hochelaga, Land of Souls, Between Sweet and Salt Water, All You Can Eat Buddha, Meditation Park, Mary Goes Round, Metric: Dreams So Real, Venus, and The Green Frog. One more in September.
"AFI Life Achievement Award: George Clooney" (July 14–September 12). George Clooney, director, producer, writer, and actor, received the 46th AFI Life Achievement Award. Film titles in August are Confessions of a Dangerous Mind, Intolerable Cruelty, Burn After Reading, Good Night and Good Luck, Michael Clayton, Syriana, Solaris, and O Brother Where Art Thou?. One more in September.
"Stanley Kubrick: A Retrospective" (July 14-September 12). Titles in August are Lolita, Dr. Strangelove, A Clockwork Orange, Barry Lyndon and the documentary Filmworker about Kubrick's assistant Leon Vitali. More in September.
"William Holden Retrospective" (July 13-September 12). August titles are The Country Girl, The Bridges at Toko-Ri, The Bridge on the River Kwai, Paris When It Sizzles, Picnic, and The Horse Soldiers. More in September.
"George Romero Remembered" (July 14–September 8). A series of films by George Romero, who died last year, continues in August with Martin, Season of the Witch, Knightriders, Creepshow and Day of the Dead. One more in September.
"Looney Tunes" (July 21-August 26) is a selection of six programs of Warner Bros. classic cartoons. See the website for details.
Two new 4K restorations are Yellow Submarine (George Dunning, 1968) on its 50th anniversary and The Producers (Mel Brooks, 1967).
Special events in August include a 2K restoration of Andrei Tarkovsky's 1972 Solaris (NOTE: the 2002 remake is also shown in August, see "George Clooney" above). "Doctor Sarcofiguy" presents a double feature of The Black Cat (Edgar G. Ulmer, 1934) and Re-Animator (Stuart Gordon, 1985) on August 25 at 7:30pm.
On August 10 at 7:30pm is Josiah, a documentary about Josiah Henson who was immortalized in Harriet Beecher Stowe's "Uncle Tom's Cabin." Filmmaker Jared Brock will be present for Q&A.
Freer Gallery of Art
A series of Japanese classic films continues at the Freer. On August 1 at 2:00pm is An Actor's Revenge (Kon Ichikawa, 1963).
During July and August is the 23rd Annual "Made in Hong Kong" film festival. The series continues in August with Legendary Weapons of Kung Fu (Lau Kar-leung, 1982) with a hip-hop score by DJ 2-Tone Jones of Shaolin Jazz on August 3 at 7:00pm. A new digital restoration of Ann Hui's first film The Secret (1979) is on August 5 at 2:00pm. A documentary about artist Yank Wong I've Got the Blues (Angie Chen, 2017) is on August 12 at 2:00pm.
National Gallery of Art
The "Bergman Centennial" (July 1-September 3) reviews the work of Swedish director Ingmar Bergman (1918-2007). More films can be seen at the American Film Institute's Silver Theater and documentaries are shown at the Embassy of Sweden. On August 4 at 2:00pm is Sawdust and Tinsel (1953); on August 4 at 4:00pm is Lesson in Love (1954); on August 5 at 4:00pm is Summer with Monika (1952); on August 12 at 4:00pm is Dreams (1955); on August 18 at 3:30pm is The Magician (1958); and on August 19 at 4:00pm is Smiles of a Summer Night (1955). More in September.
"From Vault to Screen-UCLA Festival of Preservation" (August 11-September 3) is a collection of films from Hollywood's history. On August 11 at 4:00pm is Trouble in Paradise (Ernst Lubitsch, 1932); on August 25 at 2:00pm is Stranded (Juleen Compton, 1965); on August 25 at 4:00pm is The Plastic Dome of Norma Jean (Juleen Compton, 1966); on August 26 at 4:00pm is a "cine-concert" Good References (R. William Neill, 1920) with Andrew Simpson accompanying the film on piano; and on August 26 at 5:30pm is The Murder of Fred Hampton (Howard Alk, 1971). One more in September and more at AFI Silver Theater.
Goethe Institute
On August 31 at 6:30pm is Sputnik (Markus Dietrich, 2012-3), a children's film set in autumn 1989, during the last weeks of the GDR.
The Japan Information and Culture Center
On August 10 at 6:30pm is the anime film In This Corner of the World (Sunao Katabuchi, 2016), winner of Animation of the Year award.
The Avalon
The "Programmer's Choice" film for August is the animated film Yellow Submarine (George Dunning, 1968) on August 1 at 8:00pm.
On August 8 at 8:00pm is Eight Heads of Madness (Marta Novakova, 2017), part of the "Lions of Czech Film" series.
On August 15 at 8:00pm is Montparnasse Bienvenue (Léonor Serraille, 2017), part of the "French Cinematheque" series.
On August 29 at 8:00pm is Plan B (Kinga Debska, 2018), part of the "cinePolska" series of films from Poland.
Library of Congress
"Anime for All" is held August 8-10 at the Library of Congress Jefferson Building. Activities include films, panel discussion, displays, musical performances, cosplay workshop and cosplay demonstration. The films are The Tale of Princess Kaguya (Isao Takahata, 2013) on August 9 at 1:00pm (Coolidge Auditorium) and Superman (Richard Donner, 1978) on August 9 at sundown, outside, north lawn of the Library’s Thomas Jefferson Building.
The Mary Pickford Theater
at the Library of Congress continues its series of films showcasing the Library's collection and including newly preserved films. On August 16 at 7:00pm is The World, the Flesh and the Devil (Ranald MacDougall, 1959), an apocalyptic story starring Harry Belafonte and Mel Ferrer.
Anacostia Community Museum
On August 1 at 11:30am is a film screening and discussion of the new WETA documentary Washington in the 90s, shown in conjunction with the exhibit "A Right to the City."
On August 4 at 2:00pm is a documentary film and Q&A with sculptor Uzikee Nelson Uzikee, Washington DC's Ancestral Sculptor (Doug Harris, 2018).
On August 18 at 2:00pm is a documentary The Rat Film (Theo Anthony, 2016) about rat infestation in Baltimore. A discussion follows the film.
Wolf Trap
On August 26 at 8:00pm is "Bollywood Boulevard," about Hindi cinema told through live music, dance and film from the early days to the present.
"Capital Classics" at Landmark's West End Cinema
Classic films are shown at the West End Cinema on Wednesdays at 1:30pm, 4:30pm and 7:30pm. On August 1 is Key Largo (John Huston, 1948, 1948); and on August 8 is The Band Wagon (Vicente Minnelli, 1953).
International Spy Museum
On August 23 at 6:30pm is Mata Hari, Agent H21 (Jean-Louis Richard, 1964) starring Jeanne Moreau and Jean-Louis Trintignant.
Reel Affirmations XTra
On August 24 at 7:00pm is Hard Paint (Filipe Matzembacher and Marcio Peolon, 2018) set in Brazil. A panel discussion follows the film.
Busboys and Poets
On August 5 at 6:00pm is the documentary Hebron (Yousef Natsha) followed by a discussion. At the 5th and K location.
The Phillips Collection
To accompany the exhibit "Marking the Infinite: Contemporary Women Artists from Aboriginal Australia" is Rabbit-Proof Fence (Philip Noyce, 2002) on August 16 at 6:00pm and Ten Canoes (Rolf de Heer and Peter Djigirr, 2006) on August 30 at 6:00pm.
OUTDOOR FILM FESTIVALS
Every summer, numerous locations around the DC show films outdoors.