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The Bleeding Edge Hero of the Week: Dr. Marty Makary

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“We attract good people in healthcare, but there’s this tremendous hunger to have the latest gadgets, the newest technology, without the proper evaluation of that technology. So we shouldn’t be surprised when some of the healthcare goes wrong.”

– Dr. Marty Makary

 

Dr. Makary is one of the nation’s leading advocates for healthcare transparency and a renowned surgeon at the John Hopkins University School of Medicine. With a vested interest in the responsible creation and evaluation of healthcare innovations, Dr. Makary’s lifelong work has focused on measuring health care quality, health care costs, and advocating for vulnerable populations.

Dr. Makary has led initiatives such as The Surgical Checklist, and has served in leadership roles as part of the United Nations’ WHO Safe Surgery Saves Lives Initiative. He speaks nationally and internationally on the need for patient-centeredness in healthcare and the dangers of business-centered health care.

He explains the issue in “The Bleeding Edge” documentary, “…[how] the [da Vinci] robot came into healthcare is the story of what’s wrong with medicine in America today. Massive adoption of new technology with little evaluation of the outcomes.”

A frequent commentator on television, Dr. Makary has successfully brought the conversation of medical device safety and consumer safety into American households. In addition, he is the author of hundreds of articles for outlets such as The Wall Street Journal, USA Today, the New England Journal of Medicine, and JAMA.  He is the New York Times bestselling book, Unaccountable, which sheds light on the crucial role healthcare transparency holds in empowering patients and revolutionizing medicine, and was turned into the hit TV medical series THE RESIDENT which debuted on Fox in January 2018. His newest book on the Money Games of Medicine hits bookstores in early 2019.

“The Bleeding Edge” filmmakers commend Dr. Makary for his continuous call for more transparency in healthcare, and celebrate his remarkable lifelong service to the medical field.

Watch Dr. Marty Makary in the Netflix Original documentary, “The Bleeding Edge”.

The Bleeding Edge Hero of the Week: Dr. David Kessler

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“’Regulation is bad. Let’s cut regulations. For every regulation we’re going to cut umpteen regulations.’ That bravado may apply to certain fields, but it can’t and shouldn’t apply when you’re talking about putting a device in someone’s body.”

– Dr. David Kessler

 

 

“David is what you hope for in a public servant,” said former Health and Human Services Secretary Donna E. Shalala of former FDA commissioner Dr. David Kessler. “He actually improved public health.”

Dr. David Kessler served as FDA commissioner from 1990 to 1997. He is a pediatrician, lawyer and has an advanced business degree. He was appointed by George H.W. Bush, and re-appointed by Bill Clinton. He became known for his dedication to protecting consumers by focusing on misleading marketing tactics, improving adverse drug reaction reporting systems, food and drug labeling, and tightening regulations on mammography and the use of silicone breast implants.

Following Dr. Kessler’s tenure at the FDA, he became the dean of Yale’s medical school and subsequently Dean of University of California San Francisco, where he discovered a series of financial irregularities, which he courageously brought forth, and was subsequently fired for whistleblowing. An investigation cleared Dr. Kessler of any wrongdoing regarding the irregularities, and he remained a tenured professor of pediatrics and epidemiology.

Dr. Kessler is now an accomplished author, with a variety of books on the body’s relationship to food, such as Your Food Is Fooling You and Hijacked: How Your Brain Is Fooled by Food. He has also written extensively on  the tobacco industry’s grip on American health, which was also an important focus of his during his FDA administration.

Dr. Kessler predicted that medical device regulation would become a problem when he originally left the FDA, saying,  ”The real challenges of the future will be to come to grips with how the Government should oversee the new technology.” He further discussed this in “The Bleeding Edge,” stating, “The FDA does a credible job with the vast majority of products. The problem we have is that when it comes to medical devices we built a system that doesn’t work…[the 510k process], which was meant as an exception–in that sense, a little loophole–that exception
became the rule.”

“The Bleeding Edge” celebrates Dr. Kessler’s career dedication to truthfully protecting consumers, and commends his continued work helping the public learn about industry’s role in healthcare.

Watch Dr. David Kessler in the Netflix Original documentary, “The Bleeding Edge”.

The Bleeding Edge Hero of the Week: Madris Tomes

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“We assume the FDA has the data that they need to crack down on manufacturers that have bad devices, or to recall a product, and they don’t have that…Devices can be on the market for years and cause many deaths, many injuries, before it becomes known to the public.”
—Madris Tomes

Madris Tomes is the Founder and CEO of Device Events, a software company that extracts, consolidates, and provides easy to use data on medical device adverse event reports and recalls that have been filed with the FDA. In other words, her company offers a groundbreaking service to healthcare organizations: up-to-date and reliable data–a key element in the movement for medical device safety.

Madris was previously an FDA Analyst, focusing on Unique Device Identification (UDI) and Adverse Events initiatives. Her experience brings incredible insight to the crucial need for dependable, usable data. Experts agree that the ability to better report and track device adverse event reports will have a remarkable impact in patient safety, uncovering trends, helping avoid delays in recalls and allowing both doctors and patients to make better-informed co-shared decisions about their treatment.

Madris has fought for patient’s rights and data transparency by supporting the efforts of the E-Sisters and other patient groups by offering industry guidance and joining their meetings with the FDA and Members of Congress.

“The Bleeding Edge” filmmakers celebrate Madris Tomes’ career-long commitment to medical device safety and to sustainable and long-term change in the industry.

Watch Madris Tomes  in the Netflix Original documentary, “The Bleeding Edge”.

The Bleeding Edge Hero of the Week: Jeanne Lenzer

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“The FDA is supposed to protect the public interest. Unfortunately, their behavior shows that they have been captured by industry.”
—Jeanne Lenzer

Jeanne Lenzer is a renowned award-winning medical investigative journalist and author, whose critical investigations have previously appeared in outlets such as the Atlantic, the BMJ, USA Today, New York Times, and Huffington Post.

Her first book, The Danger Within Us, is a ground-breaking exploration of the medical device industry, and how its financial influence may undermine public health. Her research helped provide important facts for “The Bleeding Edge” documentary, offering eye-opening statistics about the harms caused by poorly tested medical devices.

With an estimated one in ten Americans slated to be implanted with a medical device over their lifetime, Lenzer has continued to bring forward the issue to the American public via her book and recent articles in outlets such as the New York Times and Discover Magazine. Lenzer is also a fierce advocate for responsible journalism around medical device safety, explaining that “journalists should refrain from covering medical devices unless they have the time and expertise to take a deep dive…’industry is good at concealing bad outcomes…it takes a lot of time and effort to suss out what’s true and what’s not.’”

“The Bleeding Edge” filmmakers are grateful to Jeanne Lenzer’s commitment to exposing the grave issues in the medical device industry, and her steadfast dedication to educating the American public on it.

Watch Jeanne Lenzer  in the Netflix Original documentary, “The Bleeding Edge”, and read The Danger Within Us.

The Bleeding Edge Hero of the Week: Michael Carome

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“Most people probably believe when they get a medical device implanted–be it a pacemaker or a joint–that those medical devices have undergone appropriate testing to demonstrate that they are safe and effective before they came on the market and doctors started using them. But for most moderate and high-risk devices, that is not the case.”
—Michael Carome

As the Director of Public Citizen’s Health Research Group, Michael Carome works to improve public health by calling for corporate accountability and helping people make informed medical decisions. After working for decades as a medical doctor and a senior leader with the U.S. Public Health Service, he moved into the nonprofit world to fight for patient safety.

Carome is especially determined to hold corporations accountable for putting dangerous drugs and devices on the market, and challenging the U.S. Food and Drug Administration’s approval process for these medical products. With his leadership, Public Citizen has been instrumental in pressuring the FDA and other government agencies to uphold patient safety over corporate profits.

“Companies can develop new products that may not be safer and more effective than other products already on the market, but they will certainly heavily promote them to doctors, to hospitals, to drive up their profits,” he said in “The Bleeding Edge”.

Carome has made it his mission to expose the risks carried by these new products, and particularly by products marketed to women such as Essure and transvaginal mesh. “The FDA clearly has been reckless in failing to remove [transvaginal mesh] from the market,” he told Drugwatch.

“The Bleeding Edge” filmmakers celebrate Michael Carome for championing the rights of all people to make safe, informed decisions about their health.

Watch Michael Carome in the Netflix Original documentary, “The Bleeding Edge”.

Patient safety before corporate greed: Breast Implant Victim Advocacy’s story

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Jamee Cook, Chandra DeAlessandro, and Raylene Hollrah are co-founders of the Breast Implant Victim Advocacy group. The group was formed from their personal experiences and frustrations with breast implants, and under the guidance of the National Center for Health Research, has since grown into one of the most robust online resources on the issue. All three women saw their health deteriorate at the hands of this medical device and decided to take action, becoming advocates for patients’ rights and promoting education around breast implants. Below, Jamee, Chandra, and Raylene shed light on breast implant safety and encourage others to take part in the medical device safety movement.

Diana Zuckerman, Chandra DeAlessandro, Jamee Cook, Raylene Hollrah, and Terri McGregor

The Netflix Original documentary The Bleeding Edge is bringing the question of medical device safety to the forefront. Light is being shed not only on newer devices, but also on devices like breast implants—devices that have been around for decades.

While we hear quite often that breast implant safety has been proven and was only questioned in the nineties, that simply isn’t true. Women are complaining of the same symptoms today as they did thirty years ago. Despite innovation in breast implant manufacturing, patients are still being harmed. Women are sick, frustrated, disabled, and left with very little recourse to fight back against device manufacturers.

There are currently over 45,000 women in Facebook support groups alone who have been harmed by breast implants. Adverse event reporting to the FDA on breast implants is on the rise. Cases of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system, are on the rise. Lawsuits are being filed for women with BIA-ALCL, those who have developed cancer at the hand of devices that should be under stronger scrutiny. Breast Implant Victim Advocacy works on a national level to raise public awareness on illness and complications that can accompany both silicone and saline breast implants, including BIA-ALCL.

We encourage women to be fully informed of all risks and to explore all reconstructive and enhancement options. If you have developed unexplained illness or symptoms after breast implants, we would love to help you find a good support system of women who understand you.

We are happy to be a part of a coalition fighting for justice. Social media and platforms like The Bleeding Edge documentary are empowering patients to question the safety of all medical devices. We stand with other harmed patients to fight for better regulation, unbiased studies, stronger post market surveillance, and transparency in chemical components of medical devices. Corporate greed should not supersede patient safety.

If you or someone you care about has been adversely affected by breast implants, please visit the Breast Implant Information website, or connect with the Breast Implant Victim Advocacy Facebook group.

Watch The Bleeding Edge on Netflix to join the conversation on medical device safety.

Tammy Jackson

The Bleeding Edge Hero of the Week: Tammy Jackson

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“I’ve been told that I need to be quiet sometimes. They can take my sex life, they can take my job, they can take my farm, but they’re not going to take my voice.”
—Tammy Jackson

Tammy Jackson

Tammy Jackson and husband Byron in The Bleeding Edge

After giving birth at the age of 41, Tammy Jackson began to leak from her bladder while at work. Her doctor suggested a transvaginal mesh implant, which he described as a simple 45-minute procedure. That’s when Tammy’s nightmare began: instead of solving her problems, the mesh caused a slew of new ones, including pain, discomfort, and severe fatigue.

Eventually, Tammy found a doctor who said there was a problem with her mesh. But he told her, he was only trained to put mesh in, not take it out. Mesh is designed to be a permanent implant, and removing it can be dangerous, if not impossible. Tammy had a partial mesh removal, but her health complications have continued.

Tammy found that the mesh not only caused her physical pain, but also impacted her ability to be the wife and mother she longed to be. As someone who previously used to water ski, ride dirt bikes, and had even skydived and scuba dived, she suddenly didn’t even have the energy to play with her daughter, who in turn wondered if she was to blame for Tammy’s condition. Mesh also interfered with Tammy’s ability to be sexually intimate with her husband, Byron.

Despite all of these hardships, rather than turning inwards, Tammy felt compelled to help others with similar experiences. She and Byron became leaders in a support group founded by Lisa Mason on Facebook, Mesh Awareness Movement, for mesh survivors and their partners. She wanted the group to provide a space for partners, like Byron, to also be able to find community. “It’s hard for men to talk about,” she explains in The Bleeding Edge. “This is a safe place for us.”

Today, Mesh Awareness Movement (MAM) provides resources and support for mesh survivors and their loved ones. In addition, MAM has grown to be a platform for grassroots activism against the multinational corporations that manufacture this dangerous product. Alongside Lisa, Tammy has led rallies across the country, calling for better testing of devices and for corporate accountability for the hundreds of thousands of women harmed by mesh. In 2017, Tammy led a day-long protest outside the Johnson & Johnson’s shareholders meeting, gathering survivors from around the country and demanding the company consider the women as more than just “the cost of doing business”. She fearlessly asked stockholders as they entered the building, if they knew “they were investing in women’s pain and suffering”.

Tammy recently had to have a kidney removed because of ongoing complications from her mesh, and is in declining health. However, she is still a leader in the fight against mesh, and recently even helped host a screening of The Bleeding Edge in Independence, Kentucky (her home state). Tammy wishes there weren’t so many people experiencing the pain of dealing with a mesh implant, but she’s grateful for a space for survivors to come together and advocate for their right for safe medical care. She has told the filmmakers of The Bleeding Edge that she will never stop fighting to protect women and to stop the sale and use of pelvic mesh.

Watch Tammy Jackson tell her powerful story in the Netflix Original documentary, The Bleeding Edge, available on July 27.

The Facts in The Bleeding Edge

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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.

For deeper insight into the medical device industry, watch The Bleeding Edge on Netflix.

Diana Zuckerman

The Bleeding Edge Hero of the Week: Diana Zuckerman

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“About 95% or more of [medical devices] have not been required to be proven safe or effective in clinical trials…. Whether it’s a hip implant, or a breast implant, or certainly a cardiac implant, you would want to assume those have been studied in patients to make sure that they’re safe and that they work. But that isn’t the case.”

Diana Zuckerman, in an NPR interview

Throughout her career, Diana Zuckerman has courageously spoken out on the need for policy change and quality, comprehensive research to improve American healthcare. Currently President of The National Center for Health Research, a nonprofit organization that promotes the health and safety of adults and children, and provides consumers with free information about the risks of specific medical devices (at info@center4research.org). Diana previously spent ten years as a Congressional staffer in the House and Senate, as a scientist working in the White House, and at the U.S. Department of Health and Human Services. She conducted research while on the faculty at Vassar and Yale, and at Harvard.

Diana’s work specifically focuses on drawing attention to dangerous medical devices and corporate-sponsored medical research. In 2011, along with Paul Brown and Dr. Steven Nissen, she was the lead author on a groundbreaking study about the dangers of medical devices, determining that most devices recalled by the U.S. Food and Drug Administration (FDA) for being potentially deadly or high-risk were not thoroughly researched before being put on the market. In 2014, she was the lead author of the first study to determine that most medical implants were being sold in the U.S. without any publicly available evidence that they will benefit patients.

“Let the buyer beware before getting an implant in their body, because there may be no evidence the implant is going to benefit them and no study done in case it might harm them,” she explained.

Diana has also championed the rights of patients considering Essure to have access to the information they need to make informed choices. She has called for a “well-designed long-term study of women who underwent Essure sterilization compared to tubal ligation,” research she notes would be “long overdue.”

The Bleeding Edge filmmakers were inspired to make the documentary after seeing her speak, and are grateful for her stalwart dedication to medical device safety. They celebrate Diana and her steadfast advocacy for the rights of individuals to be fully aware of medical risks, and for patients to be valued over profits.

Watch Diana Zuckerman and her powerful call for quality medical device research in the Netflix Original documentary, The Bleeding Edge, available on July 27.

Victory! Bayer pulls Essure from the U.S. market

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Breaking news —

Seven long years after the E-Sisters began their fight against Essure, Bayer has now withdrawn the device from the US market!

This victory comes one week before the release of our film, and days after the E-Sisters rallied and hosted a preview screening outside of Bayer’s headquarters in New Jersey.

Watch the film that helped make this happen. On July 27, The Bleeding Edge premieres on Netflix.

Congratulations to Angie Firmalino and the E-Sisters for standing up to Bayer and protecting women from future harm.