The Bleeding Edge

When rich corporations win, we lose.

(2018) Documentary (Netflix) Stephen Tower, Anna Firmalino, Robert Bridges, Ana Fuentes, Julio Cesar Novoa, Jim Spencer, Rita Redberg, Jeanne Lenzer, Michael Carone, Gaby Avila, Peter Firmalino, William K. Hubbard, David Kessler, Janice Tower, Adriane Fugh Berman, Deborah Cohen, Rodney Evans, Angelia Clark, Bill Vigil, Kemal Malik, Diana Zuckerman, Adam Slater, Tammy Jackson. Directed by Kirby Dick

 

We take for granted that the drugs our doctors prescribe and the devices that they implant in our bodies are meant to make us well. We assume that they have undergone rigorous testing by the government agencies who are supposed to protect the consumer and of course we don’t question that the said devices and drugs won’t make things worse.

But that isn’t the case as this documentary shows. An indictment of the Food and Drug Administration which also grants approval for medical devices, the film concentrates on a loophole that has been exploited by companies that manufacture these devices (companies that included Johnson & Johnson and Proctor & Gamble) that allow them to escape any testing should the devices be based on devices that existed before a more rigorous testing policy went into effect.

The result is that this testing, which is expensive and time-consuming, is these days rarely put into effect as most companies make the case for their product are extensions of existing products. Thus things like vaginal mesh, the Essure permanent contraception device and artificial hips made of cobalt have been put in people’s bodies without any idea of how the products effect the human body long term – or even short term.

Veteran documentary filmmaker Dick illustrates his point with some pretty horrifying stories as we see the absolute worst nightmares of anyone planning to have a medical device implanted. Many of them involve the Essure, which is essentially a tiny coil which implants itself in the Fallopian tube and induces fibrosis and blockage. It was marketed as a less invasive alternative to a tubal ligation. However, many women who had the procedure complained of bleeding, intense pain, and unwanted pregnancies. In some cases, the devices came out of the walls of the Fallopian tube and embedded themselves in the uterus; in others the device splintered, leaving tiny shards shredding the walls of the tubes and uterus.

I won’t go further into the other products mentioned; suffice to say that there were adverse affects for all of them, some gruesome and others startling. In every case no testing was done, leaving those who had the devices implanted as essential test subjects, unknowing human guinea pigs. It is sobering to think that a government agency would allow it but the $200 billion medical device industry is powerful and as they say in Washington, money talks and lots of money legislates.

The film makes the point that the FDA, designed as a consumer watchdog agency, has instead morphed into a corporate advocacy agency. As tempting as it is to blame the Trump administration (and the problems at the FDA have worsened under the “astute” leadership of Scott Gottleib who has industry ties but no medical degree as past administrators have had) this has been going on for more than two decades – the Essure itself was approved in 2002.

The film is an eye-opener. Dick uses the various interviews and stories to alternate the history of the FDA to make a devastating indictment of a government agency that has been hopelessly corrupted from its original purpose. Certainly this should be required viewing for anyone who is preparing to have a medical device put into their bodies (and in the interest of transparency, my own wife is one of these as of this writing). It is also a sobering reminder that the medical industry is often far from benevolent; very often they are more concerned with profits over patients.

REASONS TO GO: The presentation is simple but effective. A movie anyone thinking about getting a medical device implanted should see.
REASONS TO STAY: It feels like a bad attempt to mimic a Disney animated movie from the 70s. The humor is pretty dumb.
FAMILY VALUES: There is some disturbing imagery.
TRIVIAL PURSUIT: A week before the documentary debuted on Netflix, Proctor and Gamble announced their Essure permanent contraceptive device portrayed in the film would be pulled from the market.
BEYOND THE THEATERS: Netflix
CRITICAL MASS: As of 8/8/18: Rotten Tomatoes: 100% positive reviews. Metacritic: 74/100.
COMPARISON SHOPPING: The Big Lie
FINAL RATING: 7.5/10
NEXT: American Animals

Stink!

Jon J. Whelan works the phones.

(2015) Documentary (Area23a) Jon J. Whelan, Jeffrey Hollander, Dr. Leonardo Trasande, Andy Igrejas, Cal Dooley, Leonard Lance, Jan Schakowsky, Karuna Jaggar, Brandon Silk, Rosa Silk, Jane Houlihan, Dr. Richard Denison, Dr. Jennifer Sass, Christophe Laudamie, Dr. Arlene Blum, Steve Herman, Jack Corley, Gretchen Lee Salter, Stacy Malkan. Directed by Jon J. Whelan

As consumers, we feel confident that the products on store shelves or in Internet-based shopping company warehouses are safe for consumption. We rely on watchdog government agencies like the Food and Drug Administration (FDA) or Environmental Protection Agency (EPA) to regulate which chemicals can be used and which can’t, and to know what is in the products that we buy. It might come as a shock to you that they don’t.

It came as a shock to single father Jon J. Whelan as well. Jon, whose wife Heather passed away a few years ago from breast cancer, had bought pajamas for his two tween daughters for Christmas from the tween lifestyle store Justice, whose products drove his daughters absolutely giddy with delight. However when the pajamas were taken out of their packaging, he noticed a very powerful odor that smelled “chemical” to him.

His late wife had always tried to be aware of what ingredients were in the things they consumed and used, and hyper-concerned due to his wife’s recent passing, he tried to call Justice and get a sense of what chemicals were being used for the pajamas. To his surprise, they didn’t know. He started making calls to the corporate office, to corporate officers, to Michael Rayden, the CEO of Justice – he even called the manufacturing plant in China.

He was met with a stone wall. Either the people he spoke with didn’t know, or told him that the ingredients were “proprietary trade secrets.” Looking into the laws that governed these things, he discovered that the Toxic Substances Control Act of 1976, instead of protecting Americans from the use of unknown chemicals that may or may not be carcinogenic, gave corporations loopholes in terms of labeling when it came to fragrances and flame-retardant compounds in that those items could be labeled proprietary and the companies were not liable to list the ingredients therein. In fact, after having the pajamas analyzed by a lab, he made the disturbing discovery that several of the chemicals found in the pajamas were carcinogenic – including one that had been banned by the FDA.

Contacting advocacy groups, he discovered further chilling facts – such as the incidence of breast cancer in the United States went from 1 in 20 in the 60s to 1 in 8 today, and that the amount of chemicals in the bloodstream of newborn babies numbered in the hundreds – chemicals that weren’t supposed to be there. He also discovered that consumer protection laws that regulate toxic chemical use were far stricter in the European Union than here. Even the laws in China were more strict. America had somehow become a third world country when it comes to consumer protection.

Interviews with corrupt lawmakers, corporate shills and lobbyists who not only obscured the truth but blatantly lied to legislative bodies make this akin to a Michael Moore ambush-style documentary, and in an era when distrust of corporate entities is at an all-time high, an effective method. Many advocacy groups are calling for a strengthening of the Toxic Substances Control Act of 1976, or at least an updating of it, something that industry is fighting tooth and nail.

Whelan utilizes graphics and animations that have a bit of a 60s vibe to them, colorful and cartoonish. While occasion the tech-speak can be intimidating and the presentation a bit scattershot, this is clearly the labor of love for a father still grieving for his wife, who appears in home movies interspersed throughout, along with video of his cute and bubbly daughters.

Whelan, like many of the advocacy groups whose representatives he interviews during the film, advocates for stronger regulatory powers for the EPA and the FDA, tougher restrictions on the use of chemicals, and transparency in labeling. All of these seem pretty reasonable, although when he interviews opposing viewpoints, they tend to prevaricate to almost nonsensical levels; they pay lip service to consumer protection but their actions prove the only protecting they are doing is of corporate profits. As Whelan puts it, if everything in these products is safe, then why is the chemical industry working so hard to prevent us from knowing what is in the products we buy every day?

The information presented here is sobering; there is literally almost no way to protect yourself from the use of toxic chemicals in nearly every product we use in the home. Anything that has a fragrance in it is likely to have man-made petrochemicals in it because they are far cheaper than organic chemicals. The long-term effects of repeated exposure to these chemicals is unknown; as one physician says, “We are quietly becoming genetically modified by toxic chemicals. We aren’t test subjects; we’re guinea pigs.”

REASONS TO GO: Effectively connects the dots. Clearly a labor of love. Chilling info.
REASONS TO STAY: A bit scattershot.
FAMILY VALUES: Some adult themes.
TRIVIAL PURSUIT: The movie took three years to film.
CRITICAL MASS: As of 11/28/15: Rotten Tomatoes: 86% positive reviews. Metacritic: No score yet.
COMPARISON SHOPPING: Gasland
FINAL RATING: 8.5/10
NEXT: The 33