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It Takes a Team: A Unique Perspective About Medical Device Safety

 

Ah, the human knee: the strongest joint and one of the most vulnerable. Ask anyone with knee pain and they’ll attest to that.

I had bad knees for most of my life. In high school I ran cross country and had my first knee surgery at age 17. In the decades that followed I had several arthroscopic surgeries on each knee with the well healed scars to show for it.

In 2017, I was prescribed propranolol off-label for PTSD. Its intended use is to lower blood pressure. My doctor assured me that there have been promising results in PTSD studies. It lowered my blood pressure, alright. To the point that I fainted and lost consciousness. In the fall, I broke my right ankle and injured my left knee. I had surgery on my ankle and then I went back to address my knee.

I was 47 at the time of the last injury and I was told by one of the surgeons at OrthoCarolina that I was bone on bone but too young for a knee replacement. Ideally, a patient should be 50+. I felt really discouraged at the thought of waiting years for relief and I resigned myself to just being in pain all the time.

I get it though: artificial joints have a limited shelf life. The older you are, the less likely the new joint will need revision or replacement. Knee replacement surgery is a BIG surgery and other options should be exhausted before considering such an invasive surgery.

Recently a friend of mine, who happens to also be a Mecklenburg County Commissioner here in Charlotte, NC posted about her recent knee replacement surgery and spoke highly of her surgeon. I turned 51 in 2021 and I wanted to revisit my intervention options. My friend recommended Dr. Benjamin Wooster at OrthoCarolina.

He did a thorough exam of my knee and reviewed notes from past surgeries and saw that I had tried the conservative treatments first. It was his medical opinion that I was now a candidate for total knee replacement.

When he asked me what I do, I explained that I am a Special Government Employee (SGE) at the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). In my role, I review adverse event reports for medical devices and make recommendations to FDA and device manufacturers about labeling, clinical trials, and post market surveillance.

I am also a 16-year patient advocate. This came about in 2006, when I was inappropriately prescribed Levaquin for a suspected sinus infection. I have suffered over 30 tendon ruptures as of this writing. I call it “accidental advocacy” and I’ve learned a lot since I had to navigate a complicated medical system and do my own research about the FDA approval process for medications and medical devices. I learned that in order to have informed consent that I need to work with my doctors and ask questions to help me weigh risk versus benefit.

When Dr. Wooster asked me if I had any questions, I told him I had many and explained why I was asking.

One of my main questions was about what device he uses most often and why. He told me that for my procedure, he would use the Stryker Triathlon for a total knee replacement. Having the name of the device and who makes it allows me to do my own research about the device, whether there have been any recalls or if a Black Box warning exists. When I asked him if he would be open to discussion if I found a device that I thought was safer, he told me he was open to that discussion.

I also wanted to know what the device is made of. Something we don’t often think about are what the components are made of. Typically, medical devices are made of metal and plastic. Most often out of titanium. What the average consumer doesn’t know- and that I learned in my advocacy and my work at FDA- is that coatings can be made of something different and patients are not often informed about what the other materials are made of. I asked this question because if I had a metal allergy, I could develop issues down the road. If you have a metal allergy, always let your surgeon know.

I have many allergies (NSAIDS, aspirin, sulfa, wound dressing adhesive, latex… to name a few). Luckily, I have no known allergies to metal.

Another question I had was whether he was “married” to a particular device. He understood that what I was really asking is whether he receives any consulting money from device companies. This was something I never would have thought of, had I not been involved in patient safety. If medical device sales reps have a particularly strong relationship with the surgeon, there could be the appearance of the surgeon having a direct financial incentive to use the device. Sometimes the surgeon has been flown someplace sunny to “learn about the device” on the manufacturer’s dime. My opinion on that: These relationships could unintentionally cloud the surgeon’s judgment, meaning you are not necessarily getting a fully objective view about what device is best for you. It is public information how much a doctor receives from the pharmaceutical industry and it is your right as a patient to know what those relationships are. It is one piece of a clear picture so you can decide what is best for you. After my visit with Dr. Wooster, I looked up how much he has received and confirmed that he was honest with me that he had no financial conflict of interest.  This reassured me that whatever device he and I landed on, that it was in my best interest and not financially motivated. This also reassured me that I had a doctor who was honest with me and that builds trust.

Dr. Wooster answered all of my questions to my satisfaction and as a team, we landed on the Stryker Triathlon for my joint replacement. I had it done on December 14, 2021.

I’m five weeks out now. I won’t lie: the recovery from total knee replacement is not an easy one. Knowing what recovery could look like is also something I consider when weighing my options.

As a patient who has been harmed by the pharmaceutical industry and as an employee of the FDA CDRH, I feel it gives me a unique perspective on how patients and their doctors can work together to make sure informed consent is achieved. Ask questions. Do research. Work with your medical team so you get the best possible care.

Does my position at FDA make me worried about my implanted medical devices? Absolutely. I’ve seen what can happen if a device fails or causes adverse events for the patient. Which brings me to my next point: Just because something is FDA approved, doesn’t make it safe. Here’s some information I have on my website about the approval process of medical devices that you may find helpful. (As a side note, I also have plates and screws in my C-spine that was implanted in 2008. It is monitored every year with an xray and I am happy to report I have never had any problems with it).

If you do have an adverse reaction to a medical device, it’s important to contact your surgeon but also to report that to the FDA. We look at reporting systems and data to decide if more post market surveillance is necessary or if there needs to be a change in labeling. I’ve also sat on FDA panels where a device is recommended for recall and unfortunately, the patient is the last to know.

An emerging technology is Unique Device Identifiers (UDI). UDI’s are a unique bar code specific to materials used in your surgery. Several companies are developing ways to track the UDI’s so that if a recall is issued, a patient can be notified of that. Though adverse event reporting is voluntary, I’ve made recommendations to make it mandatory and to make it easier for anyone to report an adverse event.

Patient safety is up to all of us and it can be complicated. I find that communication is key from every perspective: the patient, their medical team, and the FDA.

It is never an easy decision to have a medical device implanted but I will say this: I had enough information from various perspectives to feel comfortable in my decision to go ahead and have an artificial joint implanted.

FDA Needs Teeth: How non-compliance is dangerous for patients

FDA Needs Teeth

Historically, the FDA has often been perceived as a powerful US agency that protects the public. What most members of the public do not know is that the FDA has no enforcement powers when a manufacturer has violated a rule in a federally regulated activity.

 

My work with the FDA

I have worked for the United States Food and Drug Administration (FDA) as a Special Government Employee (SGE) and consumer representative since 2016.  I also have personal, first-hand experiences as a harmed patient, so I understand the frustrations of other harmed patients who need the FDA to listen and make necessary changes to improve patient safety.

To be fair, in my time at FDA, the agency has made changes that improve patient safety, yet it continues to lack measures to hold pharmaceutical companies and medical device makers accountable for FDA approved products that are proven unsafe.

 

How the panels work

FDA Center for Devices and Radiological Health (CDRH) advisory panels review and analyze data from both the FDA and the pharmaceutical industry, and are given briefings prior to panel hearings.  On the day of the hearings:

  • Both FDA and industry representatives give presentations and listen to the testimony of both harmed patients and those who have benefited from the products.
  • Panel members consider this information and decide whether the risks outweigh the benefits.
  • Panel members deliberate and make recommendations to the FDA.

 

What happens when there are violations?

If there have been violations of the Food, Drug, and Cosmetics Act, aka The Act* , the FDA sends warning letters to manufacturers that have violated rules in federally regulated activities.

While the letters communicate the agency’s position on a matter, they do not commit the FDA to an enforcement action.  The FDA does not consider a warning letter a final action on which a company can be sued.  Companies are given the opportunity to voluntarily take corrective action, but have little incentive to comply.

 

Testimony from a survivor

I’ve sat on many advisory panels, but one of the most notable panel hearings that illustrates the need for accountability was on March 25 and 26, 2019. The advisory panel met to discuss Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) . BIA-ALCL is a specific cancer caused by breast implants; it is different from breast cancer.

One particular testimony from survivor Roxanne Vermeland–one of over 80 speakers urging FDA to take action–stuck with me.  She is a survivor of both breast cancer and BIA-ALCL.

After surviving breast cancer and needing breast construction, she then developed BIA-ALCL from the implants. Last year, her BIA-ALCL advanced to stage 4 when it spread to her lungs. Thankfully, chemotherapy put her in remission.

While the FDA agrees that breast implants have more risks than benefits, their actions on the matter have been limited.  For example, device makers Mentor , Sientra , Allergan, and Ideal** have not complied with warning letters.

 

Limited actions – Too little, too late

Allergan issued a worldwide recall*** on macro-textured implants after the advisory panel met, but before the FDA issued a warning letter.  The warning letter was issued after the device recall because the FDA wanted recalls of ALL breast implants Allergan made, and because Allergan failed to complete long term studies as required.  Allergan still hasn’t completed the studies.

Ten months after the recalls, Allergan attempted to track down the women who still have their implants.  Many of the survivors said they found out about the recall through social media or news reports, not from the FDA.  By their own admission, FDA states that warning letters are not the final action, which brings up an obvious question:  Why isn’t there a final action?

 

The need for accountability

When companies fail to respond to warning letters, there are effectively no consequences from the FDA, resulting in continuing dangers to patients and consumers.

To be effective, the FDA needs to be more clear about messaging, follow up with manufacturers that do not comply, and have swift, strict consequences for non-compliance.  These consequences might include substantial fines for manufacturers that do not comply with regulations.

Under the current model, companies pay no fines, and  the FDA gets 50% of its funding from drug companies that pay to fast-track their products.  Fast tracking means the FDA will approve a product with little or no testing for safety and effectiveness.  This obvious conflict of interest comes at a cost to patient safety.

 

Summary

Without a strict accountability model, including consequences for companies that fail to comply with regulations, the FDA risks becoming irrelevant and ineffective, and failing in its role to protect patients and  consumers.

Notes

* The FDA was granted authority by the laws of The Act. Chapter III of The Act is called Prohibited Acts and Penalties. This section contains both civil law and criminal law clauses. Most violations under the act are civil, though repeated, intentional, and fraudulent violations are covered as criminal law. One notable 1943 Supreme Court case called United States v. Dotterweich, in which The Act uses strict liability.

** Mentor (3/19/19): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mentor-worldwide-llc-acclarent-573520-03182019

Sientra (3/19/19): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sientra-inc-573436-03182019

Allergan (5/28/20): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/allergan-607690-05142020

Ideal (5/28/20): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ideal-implant-incorporated-606103-05142020

*** In 2019, Allergan issued a worldwide recall of one specific breast implant called Naturelle textured implants around the time of the March 25 and 26, 2019 hearing. The FDA sent the warning letter a year later because FDA thinks all breast implants cause the manmade cancer and that there should be a recall on other breast implants Allergan makes, not just the one.  Allergan, per their premarket approval application, was required to do a 10 year post approval study to follow up with patients who got sick from implants.  Allergan failed to do so.  The warning letter tells Allergan that they failed to uphold the conditions of their device approval.  They never did the 10 year study, a significant violation.

 

Sexual Assault Awareness Month (SAAM) 2021

Sexual Assault Awareness Month 2021

Warning: This post may be triggering.

In the United States, someone is sexually assaulted every 73 seconds.

To address awareness about sexual assault and prevention of it, Sexual Assault Awareness Month was created over 20 years ago.

Sexual Assault Awareness Month (SAAM) is an annual campaign in April to raise awareness about sexual assault, support survivors, and give a safe space for survivors to share their stories. The color teal was adopted as the official color for sexual assault awareness.

April 6, 2021 was SAAM’s Day of Action for which people were asked to wear teal.

On April 28, 2021, it is Wear Denim Day to support survivors of sexual assault.

Denim Day is an annual event to support sexual assault survivors. It originated in Italy, when in 1999, a convicted rapist of an 18 year old female appealed the conviction and it was overturned by the Italian High Court. They blamed the victim because she wore tight jeans.

As a sign of protest, women in the Italian parliament wore jeans to work.

This was picked up internationally as a way to protest all the myths about why people are raped.

Sexual assault awareness is extremely important and it is clear why it is needed. It is not possible to prevent something no one really knows about or understands. Add to that, it’s also difficult to make people aware of a problem without providing a solution.

Sexual assault awareness is very personal for me. As a survivor, sexual assault awareness is every day. I do public speaking on it. I write articles. And I am making a film called Every 73 Seconds. Not only will I be telling my own stories of sexual assault, but also others who are using their voice and experiences to help others.

Assaulted By a Cop

In 1991, I lived in a small town in Pennsylvania. The whole town was about one mile square. It had a small police force and small fire department. Living in a small town, everyone knew everyone. I really enjoyed living there….until “that day”.

As I did every day, I went for a walk around the neighborhood. As they did every day, a police officer would stop and check on people they see, say hello, make sure they’re okay. I’d always hear them coming because the brakes on the police cars were squeaky.

A year after moving to that little town where the police took time to know the residents, I was out walking. It started to rain and it was cold. I felt relieved when I heard the squeaky brakes behind me. This officer offered to drive me home. Only he didn’t actually take me home. He pulled his police car into a dirt lot that was between my location and my apartment.

The rape was brutal. I still have physical scars from snagging my skin on his duty belt, trying to get away. When he finally stopped, he pushed me out of the car and sped away. I sat there on the wet dirt, not knowing what to do, or how to process what just happened. A police officer that I knew and trusted, who was in uniform, who is supposed to uphold the law committed a violent crime.

I walked home to my apartment, locked and barricaded the door, and cried. I didn’t want to talk to anyone or see anyone. This was uncharacteristic of me. My close friends, who were also neighbors, knew something was wrong. They knocked on the door and knew I was home. They asked me to open the door or they’d be calling the police to check on my welfare. I didn’t want to ever see a police officer again.

I remember so vividly the looks on their faces when I opened the door. I was bruised and bloody and obviously traumatized. After calming me down, they took me to the hospital where I was treated for my injuries and endured a rape exam. It was humiliating.

I was provided an advocate to be with me. Like, who do you call when the rapist is a cop? With my permission, she called a county detective who came to visit me at the hospital. The detective immediately said “Are you seriously accusing a police officer who is well liked and respected and would never do this”?

I was victim blamed by the very people who were supposed to help me. The District Attorney’s office declined to prosecute because my rapist is a “good guy” despite that a rape kit was done, I was bruised, and photos were taken of my injuries.

The victim blaming left me with deep emotional scars. To this day, even decades later, I have PTSD. I’m still triggered by the police uniform, squeaky brakes, and the smell of mud. I can’t be in confined spaces or I’ll feel unsafe.

Assaulted By a Stranger

JT, a former friend and co-director of a film we were working on about sexual assault moved in with me for 3 months in 2019.

One day she met a woman who had a reality show and a burlesque dance group. JT wanted so badly to be a famous recording artist, model, actor, reality TV “star”. Their dance performance on August 21, 2019 was at a seedy bar and JT asked me to film her performance. I did not want to go. I repeatedly told her I did not want to go. She then started to cry, saying she would feel safer if I was there. I gave in to the guilt trip.

I ended up going and I feel guilt for agreeing, considering what happened next.

I set up my tripod and camera in the front of the room. I figured I’d only be there for the 12 minute performance and then I’d leave and feel safe again.

As I was filming, a man behind me reached under my skirt and sexually assaulted me with his hand.

I froze.

After JT came home from the afterparty, I told her what happened.

She posted this:

It wasn’t just my rear end. But I appreciated her support. I felt like she had my back when other people victim blamed me that very night.

“Why didn’t you say no?”

“Why didn’t you tell security?”

“What were you wearing?”

I was wearing this:

I posted this on Twitter later that night, trying to process all of this. It was a cry for help. And I saw the irony of being sexually assaulted while filming a sexual assault film.

I agonized for 3 months over whether I should file a police report.

  • I was victim blamed
  • Police uniforms trigger me because of what happened in Pennsylvania. The thought of reporting to police put me into a panic
  • I reported the Pennsylvania rape and I was dismissed by detectives and the DA’s office. I didn’t want to go through that again.

On November 14, 2019 I decided that reporting the sexual assault at Mooney’s Lounge to police was the right thing. Officer Tilson was wonderful. It’s crystal clear that he was trauma-informed trained. He gave me physical distance so I would feel safe. He asked me if I wanted a female present during my interview. He told me that I could tell him as much or as little as I was comfortable with. He reassured me it was not my fault and that I was being very brave. He gave me space when I was triggering over his uniform. He asked me open ended questions in a very gentle tone. He told me that freeze is a normal reaction; that it wasn’t just Fight or Flight. This was a very different experience than when I reported the rape by the police officer in Pennsylvania. I felt reassured by that.

This is the police report, filed November 14, 2019.

My case was then sent to Metro Division, whose jurisdiction covers Mooney’s Lounge. I spoke at length with the detective and handed over the footage from my video camera.

When I told JT that I finally reported the sexual assault, she turned white and avoided eye contact with me. She victim blamed me. She also said “you don’t want to accuse the wrong person”, which is completely true. I don’t want to do that. The thing is, he was behind me and I never saw his face. I couldn’t identify him even if I wanted to. I only know he wore a white shirt.

JT deleted the Facebook post from the night of the assault. She pretended like she never wrote that post and she knew nothing about any of this. Good thing I took a screen shot before she took it down. She then went to Metro division and victim blamed me and made me out to be the bad guy. JT’s aspirations to be a reality TV star was more important than my safety. She sided with the man who assaulted me.

The film we were working on about sexual assault and domestic violence dismantled. She pulled the plug on it and blamed me for it, posting publicly that she thought I was stealing HER film and trying to humiliate me.  A documentary that covered sexual assault, victim blaming, raising awareness, and addressing why people don’t report sexual assault abruptly ended after I was assaulted, victim blamed by my co-director, and after I reported it to police.

People often ask me if I blame JT for the August 2019 assault. The answer is that I don’t. Blame belongs solely on the man who assaulted me.

What I do blame her for, though, is not respecting my boundaries when I told her I didn’t want go that night. And for victim blaming me and siding with the man who forcibly fondled me. She put her own self promotion ahead of her friend’s safety.

PTSD

PTSD stands for Post-traumatic Stress Disorder. This is common after a sexual assault.

Symptoms of PTSD include repeated thoughts of the assault; memories and nightmares; avoidance of thoughts, feelings, and situations related to the assault; and increased stimulation (e.g., difficulty sleeping and concentrating, jumpiness, irritability).

The victim blaming left me with even more deep emotional scars. I am triggered by neon lights, heavy bass in music, especially the 4 songs JT and her friends danced to, and being in a small room. I’m also hypervigilant, being fearful of someone behind me.

 

How to Help a Friend or family member who has been sexually assaulted

  • Believe them. The most common reason many people choose not to tell anyone about sexual assault is the fear that the listener won’t believe them. People rarely lie or exaggerate about sexual assault; in fact, survivors of sexual assault are much more likely to downplay the violence against them. If someone tells you, it’s because they trust you and need to talk to someone.

 

  • Don’t victim blame them. A common fear in telling someone about a sexual assault is that the person will think it is somehow their fault. NO ONE deserves to be sexually assaulted. Sexual assault is always the fault of the assaulter, not the survivor

 

  • Be there. It’s not easy to tell someone about a sexual assault. The survivor feels you are a safe person to talk to about the incident.

 

  • Be patient. Don’t try to rush the healing process or “make it better.” Survivors do not heal at the same pace.

 

  • Validate the survivor’s feelings. The survivor may feel anger, pain and fear. These are normal, healthy responses. They need to feel them, express them, and be heard.

 

  • Stay friends. Don’t pull away from the friendship because it’s too hard for you to handle: that will make the person feel like there is something wrong with them. You can always help them find other support people –don’t try to do it alone.

 

  • Respect their privacy. Don’t tell anyone who doesn’t have to know. Don’t gossip about it with mutual It is solely up to each survivor to decide who to tell and when.

So, Sexual Assault Awareness Month is important and something I have- for years- participated in. It’s even more personal for me having survived both times, being the target of victim blaming, and living in a culture that breeds sexual assault.

I am telling you my story, not only because it’s Sexual Assault Awareness Month, but also because I want to eliminate stigmas and end victim blaming. I am also telling you my story because I trust you with it.

Through frequent therapy and funneling my pain into a film that could help others -called Every 73 Seconds- I am learning healthy ways to cope and to love myself again.

For more information about the Every 73 Seconds documentary, click here. There is also information about how to work with me via public speaking.

 

My COVID-19 journey- Then and Now

It’s been a strange and unnerving year since the coronavirus stormed into our lives.

On March 1, 2020 I started to self-isolate because I have an autoimmune disorder called Sarcoidosis. Since I am immunocompromised, I always panic when an infectious disease makes its rounds.

COVID-19 was a new virus and not much was known about it a year ago.

The entire month of March I came in contact with three people: the pharmacy tech when I picked up my Sarcoidosis medication from CVS on March 18, a friend who delivered groceries to my home, and my husband.

I started developing symptoms around March 21. I was coughing a lot, had a fever, tightness in my chest, body-wide pain, and horrible headaches. I tried to get tested a few days later but I was turned away because I had not traveled outside the country. I was told to continue quarantining at home and just wait it out.

While I was in my own battle with the virus, two of my cousins also had COVID19.

Cousin Sharon died March 27, 2020.

Cousin Barry died March 31, 2020.

I feel a sense of survivors guilt that I survived and they didn’t. I miss them beyond words.

At the beginning of April 2020, I lost my sense of smell and taste, and my fever got worse so I went to the emergency room and was tested there.The results took a week.

April 6, 2020

April 8, 2020

April 9, 2020. Test came back positive

April 11,2020. My husband took care of me. He never developed symptoms.

April 11,2020. Interviewed by WCNC

April 12, 2020. Easter

April 13, 2020. My story went viral all over the world.

April 13, 2020. Thank you message for all the support I received.

April 17,2020. Second thank you message.

April 27, 2020. Quarantine over. Re-tested at Novant. It came back negative.

April 28, 2020. First time outside after recovering from COVID-19.

What I learned while all of this happened is that COVID-19 is not like the flu. It’s worse. Not only that, some people don’t fully recover and become what is called long-haulers.

It has been a year since my journey began with COVID-19. My pulse ox still dips to dangerous levels, I need oxygen on my bad days, and I still have intense headaches and rib pain.

May 22, 2020. Pulse ox was 81.

May 27, 2020. Pulse ox was 77.

Spent my 50th birthday in quarantine.

July 19, 2020. On oxygen due to post-COVID pulmonary fibrosis (scarring in the lungs).

February 8, 2021. One of my bad days.

Since I got COVID-19 a year ago, there have been over three million cases. Five hundred forty nine thousand people have died. It breaks my heart.

 

FDA Dermal Fillers Hearing: Consumer Representative Perspective

Disclaimer: Views in this post are my own and does not represent the views of the FDA.

On March 23, 2021, the Food and Drug Administration held an advisory panel hearing to discuss dermal fillers- Docket No. FDA-2020-N-0008

The purpose of the advisory panel hearing are:

(1) risks associated with intravascular injection of dermal fillers.

(2) patient preference and informed decision making. FDA is convening this meeting to seek expert opinion on the clinical evaluation and regulation of dermal filler products.

The hearing was somewhat complicated because dermal fillers are considered Class 3 medical devices. Class 3 means that it is “life saving” or “life sustaining” and if a patient develops adverse events, they cannot sue the manufacturer.

According to FDA there has been a marked increase in adverse events relating to dermal fillers, particularly vision impairment, blindness, and stroke. The theory is that any filler injected into any part of the face can embolize and migrate to the blood vessels and thought to result in partial or complete interruption of blood flow to the central retinal artery. There could also be inadvertent penetration of the arteries in the face by the needle or cannula. It is for this reason that I recommended to FDA to use image guided injection. I also brought up post monitoring to follow up with the patient to make sure nothing migrated or ended up where it wasn’t supposed to.
Hyaluronidase is used to melt filler that causes adverse reactions but the hyaluronidase is causing even more problems. Hyaluronidase is a medication and the filler and delivery system is considered a device so adverse reactions would be reported to two different post surveillance systems. I advised FDA to streamline those two systems so all information from both will be in the same place. We aren’t using accurate numbers if reports are in two different databases.
There was talk of issuing medical device cards to patients that has the name of the filler, the means of delivering it with the patient’s name, contact info, manufacturer contact information and a list of possible risks. Often patients are not told what they are being injected with so I think it might be helpful to have that.
Also risks should be conveyed both verbally and written with a checklist that the physician and patient both sign off on as having been discussed and read so there is informed consent. The language should be clear and specific so there is no confusion. The majority of patients harmed by dermal fillers report that they were never given clear possibilities of risk.
One thing I must speak out about is that the panel chairman Dr. Frank Lewis ignored me when I raised my hand. I had to message him to tell him it is unacceptable to ignore the consumer representative but allow the physicians on the panel to talk as long as they wanted. This also happened when I was the consumer representative for the breast implant hearing 2 years ago. I pulled him aside during break and told him it’s disrespectful and unacceptable to silence a consumer representative. To his credit, after pulling him aside both times, he did call on me when I wanted to talk. It shouldn’t have to be this way though. All panel members should have an equal seat at the table.
The slides we were given for the hearing can be found here. It is now on public record so I can share these now.

To listen to the hearing in its entirety, click here.

 

 

 

National Adverse Drug Event Awareness: 12 questions to ask your doctor and why you should be asking them

March 24 is National Adverse Drug Event Awareness Day. I wish I didn’t have to know that, but since 2006, I’ve been disabled from adverse reactions from Levaquin- a fluoroquinolone antibiotic. Over 30 tendon ruptures, nerve damage, bone and muscle pain, brain fog, neurodegeneration, autonomic and central nervous system damage. I could go on but we’d be here all day.

I have a unique perspective on adverse drug reactions.

I’m a harmed patient. I also work for the U.S. Department of Health and Human Services. I’m an SGE (Special Government Employee) at the U.S. Food and Drug Administration and I collaborate with the Centers for Disease Control and Prevention. I’m also a team leader and patient safety expert at the American Society of Pharmacovigilance STRIPE Initiative. In addition, I’m a contributor at Drugwatch, Medshadow Foundation, and Health Web Magazine.

The combined experience allows me to help others so that they can make informed decisions about their health. Trust me, what you don’t know can hurt you, and sometimes the treatment is worse than the illness.

“But Rachel, all drugs have side effects”. I get that one a lot. Side effects are things like dry mouth or constipation. Adverse drug events are completely different in that it flips your world upside down and sideways. We’re talking about life-changing, often permanent, health problems that stem from a medication.

In the next few weeks I am going to be writing more content around Adverse Drug Event Awareness Day and this is my jumping off point. Every patient has the right to information regarding their health and well-being in order to make informed decisions. Finding the balance between lack of transparency and wading through vast amounts of information often comes down to asking the right questions.

Had I known that Levaquin was not appropriate for my particular health issue, and had I asked questions, I’d have been able to give informed consent.

The following are 12 questions to ask your doctor when the subject of new medication is introduced. It comes from years of personal experience as well as professional experience being a patient safety advocate. I will also explain why asking these questions are important. Having as much information as possible allows you to paint a complete picture about what you feel is best for you and to determine the risk-benefit ratio.

Questions to Ask If Your Doctor Brings Up a New Medication

  1. Do you mind if I record this conversation with my phone so I can have it to refer to when I do my research?
  • Why is this important?: Recording a conversation means that you won’t have to rely on your memory to recall information during your visit. It also increases the likelihood that there will be more transparency about the risk vs benefit ratio of a new medication.

2. For what condition is this medication prescribed?

  • Why is this important?: Drugs often have more than one use. Understanding why a drug is being prescribed increases your knowledge of the medication and the condition for which is it prescribed.

3. Is it being prescribed off-label? If so, is there another medication specific to my condition?

  • Why is this important?: Prescription drugs are often prescribed for uses other than what the FDA has approved. This is legal, and in fact common. The FDA regulates the approval of a drug, not how it is prescribed. At least one in five outpatient prescriptions are prescribed off label and doctors are not necessarily required to inform a patient that a medication is being prescribed off label. Off label use is not necessarily a bad thing but it is important that a patient is fully aware of what they are taking and for what condition.

4. What are the risks associated with this medication and do the benefits outweigh those risks?

  • Why is this important?: Adverse reactions (ADRs) or adverse events (ADEs) can have a major impact on the health and well-being of patients. It’s something that I found out the hard way. I was never informed of the adverse reactions associated with Levaquin, many of which are permanent. Sometimes, unfortunately, the treatment can be worse than the illness for which it is prescribed. FDA approved does not always mean that a product is safe. Having a complete picture of the risk vs. benefit helps patients make an informed decision about their care and appropriate use of the medication.

5. Is this a new medication? If so, is there an older, more tried-and-true medication available?

  • Why is this important?: Newer doesn’t always mean better. There is no regulation requiring new medications to be better than older medications before they are approved by the FDA. The FDA approves approximately 20-25 new and unique medications annually. Of those, only four or five represent major advances for conditions with no decent treatment choices. The remaining new medications offer only marginal improvements or are combinations of what is already on the market, which are called “me too” drugs.

6. Is this medication necessary to my well being or are there alternative treatments I can try first?

  • Why is this important?: There may be other medications to consider for your condition. Some medications may be more effective but carry greater risks. There is also cost to consider. In some cases, medication may not be needed at all and other treatments may be available.

7. Will this medication interact with my other medications and/or other health conditions?

  • Why is this important?: Drug interactions may make your medication less effective, cause unexpected side effects, or increase the action of another drug. Medications can react with other medications, food, or beverage.

8. What are the Black Box warnings for this medication and where can I report adverse events?

  • Why is this important?: Black Box warnings are the strictest warning put in the labeling of prescription drugs by the FDA when there is reasonable evidence of association of a serious hazard with the drug, which can be life-threatening. Asking about Black Box warnings can help to protect your health and life. If you do experience an adverse reaction, it is important to report it to the FDA’s MedWatch, which can be found here.

9. What happens if I do not take this medication?

  • Why is this important?: You know what is best for you. You may decide that a medication has too many side effects, costs too much money, or you may think you might get better with alternative treatment. Asking what happens if you do not take a certain medication allows you to make an informed decision about what is best for you.

10. What is the cost of this medication and will insurance cover it?

  • Why is this important?: Many patients may face high out of pocket costs for prescription drugs each month, especially for those with chronic or multiple conditions. Even insured patients feel the burden. When the cost is too high, a patient may stop taking the medication, and this could be detrimental to the patient. Understanding the cost of prescription medications and whether it is covered by insurance can help prevent complications from stopping a medication cold.

11. Do you have any written information about this medication?

  • Why is this important?: Patients need accurate information to help them use their medications safely and effectively. Having written information to refer to helps patients fully understand everything they need to know.

12. Have you ever received any gifts or financial benefits from the company that makes this medicine?

  • Why is this important?: Doctors are not required to disclose payments they receive from pharmaceutical companies to prescribe their drugs. Patients want to know that the medication being prescribed is because it is in their best interest, not because doctors receive money to do so. Understanding these ties is important. Many brand name drugs are expensive and carry dangerous adverse reactions. As a patient and consumer, you have the right to know whether your doctor has close pharmaceutical ties. You can find out here.

 

 

Rest in peace Ed Hollingsworth

The world’s light dimmed today on those of us who were gifted to have known him. I heard of the passing of my friend Ed Hollingsworth this morning.

People come into your life for a reason. You know that person who just stands out for all the right reasons? That was Ed.

The first time I met him was at a Consumer Reports conference in Washington, DC. It was the first time I dipped my toe into the patient safety waters. New to this and quite honestly a little intimidated being surrounded by the best patient advocates across the country, I kind of wondered how I got to be around such stellar talent.

People were gathered in small groups when I walked in and I tried to find the table with the least amount of people to carve out a little space. They all knew each other, almost like a family reunion. I didn’t know anyone and even though it’s hard to tell when the Jersey in me comes out- or when I go off on a rant- I’m actually quite shy at first. Painfully so.

I sat at that table feeling out of place. I don’t know if my awkwardness was obvious but over comes a big, smiling guy. This sounds so cliché but his smile really did light up a room. He introduced himself as Ed and sat down next to me.

The above photo is Daniela, me, and Ed.

It was small talk at first. He maintained eye contact but I noticed he occasionally looked off to the middle of the room, and smiling even bigger.

“See her?”, pointing at his wife Marian, who was close by and talking with other people.

“That’s my wife. She is so amazing.”

She is exactly that.

I remember his smile so well. It was a smile that spoke so much but in no words. There was a sparkle there. I couldn’t help but chuckle a little bit because it was a blend of school boy crush and a love you only see in movies and wish to aspire to.  Best friends. Two people in one soul. It sounds weird to say of a couple you just met. There was something so genuine and precious there.

I don’t really remember how we got on the subject of chocolate. It was probably some piece of bagged mini candy bars on the table but he said “You want to see chocolate? My wife makes THE BEST”. I scrolled through his phone looking at boutique-level gorgeous chocolate covered Easter Eggs and Reece’s dipped in chocolate and toffee. He made a little quip about how he shouldn’t be eating it (patting his stomach) but said he just couldn’t help it.

His wife Marian finished her conversations and sat next to Ed. I noticed he held her hand on the table. That memory sticks with me when I think of Ed.

Before the conference officially started, he leaned toward me and said “We’re all family here. You included”, and then the conference speaker started speaking.

I remember at some point the conference ended for the day. We were in a hotel lobby waiting on delivery food.

Ed was sitting down and I had arrived a little late. He stood up and offered the only seat available at the table. As people were getting annoyed by the late food delivery, the seat next to me opened up. Across from me was Robyn, a survivor of patient harm. I remember Robyn started singing. It was beautiful and soulful, just like her, and Ed started singing along with her and he had the biggest smile. Their voices intricately woven and blended when they sang.

That’s when I found out about his and Marian’s love of theatre. In high school I remember the plays the drama department did. I got to watch a lot of them back stage as prop department person number 3. I mentioned a couple songs I remembered from them and he knew them all by heart. He was an actor. As he showed me photos of performances, he hummed some of the tunes.

As an aside, we did get the food we ordered but it’s the people and the music that sticks out.

When the conference ended, we all hugged and went our separate ways. Ed was right. We became family. It’s been a while since we all got together but you wouldn’t really know it because the bonds are strong.

I got to know Ed and Marian a lot better through our work in patient safety and on social media. They are the foundation on which I continued my work in patient safety. You see this woman here before you? A much different- and better- person because of their work and their friendship.

Ed posted all the time about his walks with Marian in their neighborhood. I can still see the vivid sunset pictures. One photo that I remember clearly is an un-posed photo of her and a dog. He expressed how much he loves his wife and how she is his best friend.

Another conference came up not too long after the first one. This was in Yonkers, New York.

It is at this point I need to mention that during those years I had a wicked flying phobia.

My flight had been delayed because of a hurricane so I flew out the next morning. I posted a photo half in jest, half in needing moral support. It was of me. Terrified.

Because my flight was delayed, it was the day after I was supposed to leave. I calculated that I’d arrive at the airport in New York, catch the driver and be delivered to the steps of Consumer Reports riiiiight about when it started. I was right. It started minutes before I walked in. The introductions had just started.

 

As you can imagine with any phobia, I arrived at Consumer Reports pretty rattled. I was escorted by someone at the front desk. The room was packed. Except the seat next to Ed. In the middle of intros, he stood up and gave me a gigantic hug. It was the kind of hug where you felt safe. Home.

Marian stood up, smiled, and hugged me too.

During one of the breaks, I saw that Ed had his arm around Marian. I don’t know why but I felt so compelled to take a photo.

 

I’m glad I did. This would be the last one I ever take of him, at dinner.

In my mind, I still remember how he playfully “made fun of me” for being THAT person taking photos like a tourist. I smile at that. I am that person.

I knew he was sick recently. Not a lot of people did. I don’t think I knew the full extent of how fast his cancer was. But I knew his posts were less frequent and with less spark than before. I knew why.

He last posted in early to mid-September. I went back and read them again this morning.

The announcement I dreaded, that Ed was extremely sick and Ed’s family asked friends and family to post for Ed, broke my heart into more pieces than I knew I had. Marian read Ed the messages. If there is any comfort at all in this, it’s that Ed knew he was loved by all.

Even over time zones and many miles between us, it was like the air got sucked out of the room when I read this news.

I hadn’t prepared for that kind of spark to go out.

Ed was the strongest, most genuine, friends-into-family kind of guy. He spoke his mind. But had a compassion unique to him. A smile that is only his.

I got word last night that Ed passed, surrounded by his family.

I had this all written in my head before I started typing. It was a lot more eloquent than this and I’m sobbing at the loss of my dear friend. I got to know Ed and his family. You won’t find anyone as dedicated to his family. They are his center.

Damn, Ed. You had a way with words and the right ones elude me right now. I look back in my Facebook albums and Ed and Marian are smiling in every one of them.

Thoughts and prayers seem so small as I’m writing this for a man who loved his life.

The sky has one more star named Ed.

Rest in peace, my friend.

Hydroxychloroquine: Conspiracy vs. evidence-based science

By now, we’ve all seen the viral video from Breitbart with doctors claiming they have cured Covid. People are tagging me in these posts, asking if I’ve seen it.

Yes, I’ve seen it.

I’m going to preface this by saying that I work for the U.S. Department of Health and Human Services. My job is to analyze data. I am also a contributor for Drugwatch and Medshadow Foundation, both of whom are experts in drug safety. And I’m a founding member of the American Society of Pharmacovigilance STRIPE initiative. I’ve also had Covid. While none of those things makes me the end-all-be-all expert on it, I can speak intelligently on the matter given my background and training.

One of the more outspoken of those in the video is a Houston primary care physician and minister. She spouts all kinds of conspiracy theories and passing them off as fact. This particular physician has a long history of conspiracy theories. She believes in alien DNA and demon sperm. So, there’s that.

Now let’s get to the hydroxychloroquine. I’ve written about this before and you can click here to read that.

The claim that the FDA approved hydroxychloroquine for Covid is false. The claim that it cures Covid or that a prophylactic dose will prevent Covid is also false.

There is a lot of misinformation going around on social media so let me explain how evidence-based science works.

There are several levels of evidence.

  • Experimental data. The word experimental is key here. Could coronavirus be killed in a test tube? Sure. At high enough doses, any virus can be killed. But it can kill your loved ones too. Just because something sounds good, doesn’t make it a viable option.
  • Anecdotal data. The key word is anecdotal. An example of anecdotal evidence is “welp, some guy in a grocery store said it cured his neighbor”. You don’t know the rest of the story, what other factors went into it, and quite honestly, trusting some random dude just because it sounds hopeful is dangerous . Another example of anecdotal evidence is when doctors do a press conference and give cool sound bytes but doesn’t give any actual information. I’ll also add that there was no comparison group. Anecdotal evidence isn’t evidence.
  • Cohort study data. So here, you’re comparing two groups. People who took this treatment and people who did not. Cohort studies are great to form a theory but makes no sense in practice.
  • Randomized control trial. NOW we’re at the first level of using actual evidence. This is where you would take a person who is positive for Covid and then either that person gets the drug treatment or they get a sugar pill. The pros of a randomized control trial is that you’re comparing identical groups. The cons of this, on this particular issue, is that hydroxychloroquine has more risk than benefit.

What you’re seeing on social media is not evidence of benefit. It’s sound bytes and nothing but anecdotal data.

Has hydroxychloroquine treated Covid patients successfully? I’m hearing anecdotally that it has. It also comes with enormous risk and has not actually been approved by any authority for Covid. Like fluoroquinolone antibiotics, certain medications should only be used for the most severe cases, in a hospital setting and when all other options have been exhausted.

Hydroxychloroquine is one of them.

There can’t be informed consent about any treatment unless a patient has all the information. Credible information.

Please be safe.

The Strings Attached documentary statement

It was recently announced by Jennifer Tucker, my former co-director on The Strings Attached documentary that she pulled the plug on the film and has made public, libelous (criminal) allegations that I tried to hijack the project from her. These allegations are absolutely false. It is against my own personal ethics and professionalism. My professional reputation speaks for itself.

I am disappointed and hurt that she would make such an egregious accusation.

If she decides to complete the The Strings Attached Documentary on her own, it is a film I will still support from the sidelines.

 

COVID-19 update

I would like to express my sincerest gratitude to everyone who has reached out and sent well wishes after reading about my experience with COVID-19. It has been truly touching.

As previously reported, I have been practicing social distancing and was only in contact with three people in the past three weeks, one of which did test positive for the virus. Some reports have implied groceries or packages were how I contracted the virus. I want to be clear, at this time, no one can be 100 percent sure of the source.

As a long-time patient advocate, I appreciate the opportunity to be of service and educate the public. However, right now, my health is of the utmost importance and for the immediate future, I am focusing exclusively on fighting this terrible virus and getting better. I would appreciate the media respect my privacy at this time.

 

COVID-19: Is chloroquinine the answer?

COVID-19. Coronavirus. Coronapocalypse.

Whatever you call it, we are embarking on uncertain times. We’re in the midst of a global pandemic and “social distancing” isn’t just a fancy hashtag.  It’s a necessary measure to contain the spread of this thing. As we should.

As of this date- March 20- here in Charlotte-Mecklenburg, North Carolina, we have 11 new cases in one day, bringing the total (that we know of) to 43. Given the lack of resources and testing kits, we may never know how many actual cases we have here. Nevertheless, the reported cases are concerning, not just for where I live, but across the country in all 50 states. And the world.

Eat-in restaurants are ordered to shut down. Schools are out for the rest of the year. Stores ran out of non-perishables. People are hoarding things. (And as an aside, I’m immunocompromised because of an antibiotic and have not been able to find face masks ANYWHERE… but that’s a whole other article).

I’ve been a healthcare advocate for well over a decade, after an antibiotic called Levaquin disabled me. It made me realize that adverse events are largely hidden from the public, drugs are fast-tracked through the FDA, and that there are a lot of failures within healthcare. I’ve collaborated with the Centers for Disease Control and Prevention (CDC) regarding drug safety surrounding the appropriate use of fluoroquinolones. I also serve as a Special Government Employee (SGE) at the U.S. Food and Drug Administration.

To quote Farmers insurance ads, “I know a thing or two, because I’ve seen a thing or two”.

The conversation turns to treatment when there is a pandemic and pharmaceutical companies are rushing to come up with the next-best-thing for a cure. I’m concerned about this pandemic but there is an added layer to my concerns.

Chloroquinine.

Chloroquinine became a household name overnight and because of my experience and expertise in medication safety, I’m often asked my thoughts on it.

Chloroquinine is an old-school anti-malarial drug discovered by Bayer. It was largely dismissed because it was considered too toxic for human consumption. It is the basis of current fluoroquinolone antibiotics. If you’ve been following me for any length of time, you know I have some very strong thoughts about fluoroquinolone antibiotics like Levaquin, Cipro, and Avelox. [Click here for information about fluoroquinolones]

Chloroquine is a cousin of quinolone antibiotics, or quinolone-adjacent. Quinolones are essentially chloroquinine + nalidixic acid. Many of the early quinolones were removed from the market because of its toxicity. Then came the emergence of current fluoroquinolones, which is chloroquinine + nalidixic acid + fluorine atom. The FDA ruled in 2015 that fluoroquinolone antibiotics carries more risk than benefit. This came after 35 patients who were harmed by Levaquin, Cipro, and Avelox, including myself testified at the FDA about the permanent adverse events we suffered.

I mention this because I’m trying to show a pattern of toxicity and why I am speaking up about my concerns.

To combat this novel coronavirus, pharmaceutical companies are racing to find a treatment and in a recent press conference, chloroquinine and hydrochloroquinine (Plaquenil) were mentioned as possible COVID treatment. I’m scared that we are making decisions without reliable data and that more harm than good will come of this. Fast-tracking through the FDA sounds like a good thing, but often, it isn’t. Approving something and asking questions later has led to years- even decades- of suffering before evidence comes around saying something isn’t safe after all.

I realize that lives are at stake here. But as always in my advocacy, I believe that consumers have the right to as much information as is available so they can make an informed decision about their health.

Hydrochloroquinine, or Plaquenil, comes with the same adverse events as fluoroquinolone antibiotics: gastrointestinal issues, psychosis, brain fog, cardiac issues, and peripheral, autonomic and nervous system dysfunction- and more, including death.

Very little is known about the coronavirus. Very little is known when drugs are fast-tracked. Are we adding fuel to the fire with chloroquinine or hydrocloroquinine? That depends on how you look at it, I suppose.

My own personal opinion is this: as with fluoroquinolones, they have the capacity to save lives, but they also have the capacity to harm. Perhaps chloroquinine is appropriate for severe cases or when there is no other alternative available. That is between a patient and their healthcare provider, and I’m not a doctor. All I’m saying is thoroughly research any drug or treatment before taking them. Otherwise, we are going to see more risk on top of an already risky situation.

I will say this: chloroquinine, or any other drug for that matter, has not been proven to treat or prevent coronavirus safely and effectively. This fact must be considered when making a decision.

One of the ways to contain coronavirus is to maintain social distancing, wash your hands, and take measures to prevent it in the first place.

 

Confirmed cases in Charlotte-Mecklenburg updates:

March 21- Went from 43 cases confirmed to 77.

March 22- 80

March 23- 97

March 26- 204

March 27: 259

March 28- 299

March 29- 315

March 30- 382

April 1- 533

April 3- 601

April 5- 665

April 6- 733

April 7- 810

April 8- 839

April 10- 906

April 15- 1,015

April 17- 1,136

April 21- 1,255

April 22- 1,331

April 23- 1,377

April 24- 1,424

April 27- 1,492

May 3- 1,724

May 8- 1,983

May 9- 2,055

May 10- 2,074

May 12- 2,158

May 13- 2,283

May 15- 2,374

May 18- 2,646

May 19- 2,695

May 27- 3,530

June 1- 4,412

June 16- 7,117

June 19- 7,767

June 30- 10,367

July 1- 10,829

July 14- 14,981

July 18- 16,603

August 26- 24,952

September 1- 25,575

 

 

 

 

 

 

 

 

 

 

 

 

Are Your Sterile Implants Really Sterile?

Are Your Sterile Implants Really Sterile?

 

I have been on both sides of patient safety for over 13 years.

On the one side, I am a harmed patient who suffered a multitude of adverse events stemming from pharmaceuticals and medical devices, including contracting Methicillin-resistant Staphylococcus aureus (MRSA) and Sepsis. In addition, I have had over 3 dozen surgeries, some of them resulting in errors and infections.

On the other side, I am a Special Government Employee (SGE) at the U.S. Food and Drug Administration’s Center for Device and Radiological Health (CDRH). As the consumer representative on the Advisory Committee, my role is to analyze scientific data, understand research design, discuss benefits and risks, and evaluate the safety and efficacy of medical devices under review.

I was recently contacted via LinkedIn by Dr. Aakash Agarwal, Director of Research and Development for Spinal Balance Inc. at the University of Toledo to tell me about the growing problem of device contamination. After a brief phone call, Dr. Agarwal sent me research literature. I was alarmed by what I read and I feel that this matter needs to be brought to the public’s attention, including patients, physicians, and regulators. I agree with Dr. Agarwal that a public hearing needs to be held at the FDA to discuss the pedicle contamination. This is a matter that is not talked about and it should be.

Pedicle screws are used in spinal fusion surgeries to add extra support and strength to the fusion while it heals. The screws are placed above and below the vertebrae that were fused. A rod is used to connect the screws which prevents movement and allows the bone graft to heal. They can become contaminated and it is a growing problem in the United States; a fact that most people don’t know.

Bacterial infections following spinal surgery are estimated at 12.7% according to Dr. Agarwal.

The average hospital bill following such infections is $63,000, with hospitalization being necessary in 5.5% of those cases.

Pedicle screws are the most common implant used in spinal fusion surgery. A surgeon will typically have over a hundred screws available for use during surgery, but actually uses a small amount.

The pedicle screws’ low usage rate leads to these screws being repeatedly reprocessed—or “automated washing with contaminated instruments from theatre and then sterilized without prior inspection by hospital staff” by the sterilization processing department (SPD).

In essence, these “sterile” implants, alarmingly, have been found to contain contaminants.

Furthermore, unused pedicle screws are subject to contamination during surgery.

Pedicle screws are linked to MRSA infections during their handling during the procedure, and during the reprocessing before and after surgery. MRSA is a bacterium that causes infections in different parts of the body and it is tougher to treat than most strains because it is resistant to some commonly used antibiotics. Re-processed screws have been found to harbor corrosion, biofilm, endotoxins, fatty tissue, and soap residue mixed with fat, whereas exposed pedicle screws in “sterile-field” become contaminated. These infections were present in at least 10% to 30% of patients with chronic pain and were detected only during revision spine surgery. I have these screws following spinal surgery and suffered infections as a result.

In order to keep pedicle screws from becoming contaminated, researchers are suggesting providing the implant in an individual sterile pack (single-use and ready for implantation), and each implant should have a functional guard around it to protect from direct exposure during handling. Dr. Agarwal and his colleagues co-authored a study to determine the magnitude of the issue, and how to prevent surgical site contamination linked to pedicle screws in spine surgery.

Dr. Agarwal explains it like this:  “The single center study as well as our multicenter study, showed that all unguarded screws resulted in bacterial contamination inside the “sterile field” during live surgeries, whereas guarded screws had no such contamination. The key constituents that define the pathogenesis of SSI (Surgical Site Infection) are the virulence, host-site immunity, and dosage. We demonstrated the preventative method effective on reducing the dosage of bacteria.”

The guards used on the single-use pedicle screw are commercially available.

Dr. Agarwal has filed a Citizens Petition with the U.S. Food and Drug Administration calling for a ban on the reprocessing of pedicle screws in the U.S. It is currently under review, a process which could take a year or longer. Agarwal requests “the Commissioner of Food and Drugs to cease clearing 510(k)s and approving PMAs [pre-market approvals] for reprocessing of pedicle screws and other implantable orthopedic devices and cease clearing 510(k)s for re-usable implantable orthopedic device[s].”

In addition to asking for the cessation of approvals for reprocessed pedicle screws and interbody cages, the petition requests that every implantable orthopedic device should be provided “such that it is not touched or exposed before implantation, by the operating room staff, in the sterile field.”

I am a patient who has undergone dozens of surgeries and have several medical implants. This is all information I wish I had known prior to my surgeries. Contamination is preventable and reprocessing needs to be banned.

Your life could depend on it.

About The Author

Rachel Brummert is a Special Government Employee at the U.S. Department of Health and Human Services and the Patient Safety Director at ION Medical Safety. She is also CEO of Patient Safety Impact, headquartered in Charlotte, North Carolina.

Media Inquiries: rachel@rachelbrummert.com

 

FDA Internal Surgical Staples and Absorbable Collagen-Based Hemostatic Device Hearings: Consumer Representative Perspective

Disclaimer: Views in this post are my own and does not represent the views of the FDA.

On May 30, 2019, the FDA Advisory Panel committee discussed and made recommendations regarding the reclassification of surgical stapler devices for internal use from Class I (general controls) to Class II (special controls).

On May 31, 2019, the committee discussed and made recommendations regarding the reclassification of certain Absorbable Hemostatic Agents from Class III to Class II (special controls).

I served as Consumer Representative for both hearings.

Internal Surgical Staples

The advisory committee met to discuss the April 2019 proposed reclassification order after the following risks to health were discovered:

  • Complications associated with device failure/malfunction. Device failures or malfunctions may result in prolonged surgical procedures, unplanned surgical interventions, and other complications such as bleeding, sepsis, fistula formation, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.
  • Complications associated with use error/improper device selection and use. Use error may result from a device design that is difficult to operate and/or labeling that is difficult to understand. For example, user difficulty in firing the stapler may result in staples not being fully deployed, and misfiring may result in staples being applied to the wrong tissue. Inadequate instructions for use may result in selection of incorrectly sized staples for the target tissue. When staples are applied to the wrong tissue or when incorrectly sized staples are applied, staples are unable to properly approximate the underlying tissue, resulting in tissue damage, anastomic leakage, and bleeding. This in turn may lead to more severe complications, such as abscess, sepsis, peritonitis, hemorrhage, or death.
  • Adverse tissue reaction. If the patient-contacting materials of the device are not biocompatible, local tissue irritation and sensitization, cytotoxicity, or systemic toxicity may occur when the device contacts sterile tissue.
  • Infection. If the device is not adequately reprocessed or sterilized, the device may introduce pathogenic organisms into sterile tissue and may cause an infection in a patient.

Surgical staplers are currently classified as Class I devices. Class I are “low risk” devices. Low risk devices are not tested. These include items such as band-aids, tongue depressors, crutches, and are subject to General Controls. The proposal would reclassify surgical staplers to Class II. Class II devices are considered “moderate risk”, and subject to Special Controls.

In the proposed reclassification order, FDA proposed that the following special controls would mitigate the risks to health and provide reasonable assurance of safety and effectiveness for surgical staplers for internal use:

  • Performance testing must demonstrate that the stapler, when use with compatible staples, performed as intended under anticipated conditions for use. Performance testing must include evaluation of staple formation characteristics in the maximum and minimum tissue thickness for each staple type; measurement of the worst-case deployment pressures on stapler firing force; measurement of staple line strength; confirmation of staple line integrity; and in vivo confirmation of staple line hemostasis.
  • Usability testing and labeling comprehension study must demonstrate that the clinician can correctly select and use the device, as identified in the labeling, based on reading the directions for use.
  • The elements of the device that may contact the patient must be demonstrated to be biocompatible.
  • Performance data must demonstrate the sterility of the device.
  • Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling.
  • Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life.

Labeling the device must include that unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of necrotic or ischemic tissues and tissues outside of the labeled limits of tissue thickness; unless available information indicates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazrads associated with the device including:

  • Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures
  • Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage
  • Avoidance of use of the stapler on large blood vessels, such as the aorta
  • Establishing and maintaining proximal control of the blood vessels prior to stapling
  • Appropriate measures to take if a stapler malfunction occurs while applying staples across a blood vessel, such as clamping or ligating the vessel before releasing the the stapler, while the stapler is still closed on the tissue
  • Ensuring stapler compatibility with staples

Reported adverse events are 412 deaths and 11,000+ injuries. Seventy-two percent are from linear stapler and 17% were from circular stapler. Thirty percent was during the procedure and 52 occurred post operative.

Madris Tomes, CEO of Device Events and former FDA employee, reported even higher numbers. She also presented information regarding materials in staples- most specificially nickel- which can cause allergy and autoimmune issues.

Immediately following, the Panel Chairman ruled that we as a panel cannot discuss the staples; only the staplers. My opinion, and that of other panel members, is that you cannot discuss staplers without also discussing staples but the Chairman harshly shut down the discussion. It still makes no sense to me since Medtronic, a maker of surgical staplers (and the only surgical stapler manufacturer to show up for the hearing) wanted to discuss biocompatibility and the FDA themselves proposed biocompatibility testing of the staples in the special controls.

Both Medtronic and the FDA admit that adverse events are underreported. When I attemped to ask the FDA what they plan to do to improve their reporting system and be transparent about adverse events,  I was cut off by the Chairman. This highlights the concern about whether FDA truly values the patient and consumer perspective when all other panel members were permitted to ask multiple questions, but the Consumer Representative was not.

At the end of that hearing, the advisory panel voted unanimously to up-class internal surgical staplers from Class I to Class II with special controls.

The staples themselves, unfortunately, will have to be a separate discussion due to the subject being shot down at this one. I encourage all readers to do research about surgical staples prior to sugery. It is a discussion that needs to be had and patients have the right to know what is going into their bodies.

 

Absorbable Collagen-Based Hemostatic Agents

On Day 2, the panel discussed reclassifying absorbable collagen-based hemostatic agents from the current Class III classification to Class II with Special Controls. We were instructed to not consider added biologics.

FDA identified several risks to health for absorbable collagen based hemostatic devices:

  • Uncontrolled bleeding. Failure to completely control bleeding can lead to death or severe injury.
  • Hematoma. If small amounts of bleeding persists following application of an absorbable collagen-based hemostatic device, the accumulation of blood behind the device will form a hematoma. A hematoma may press on soft tissue and cause soft tissue or nerve damage. It also has a high mortality rate.
  • Infection. An absorbable collagen-based hemostatic device may serve as a nidus for infection and abscess formation. They are manufactured from materials derived from animal sources such as collagen and gelatin and bacteria can grow on device materials.
  • Wound dehiscence. Devices near the sites of incision closures has interfered with the healing of the incision. This interference is due to mechanical interposition of the device and is not due to intrinisic interference with the wound healing process.
  • Foreign body reactions. These devices have been associated with foreign body reactions involving fluid accumulation due to encapsulation of the device. This has resulted in granuloma formation, inflammation, and edema, which may require surgical removal. Encapsulated devices can also present as an image artifact mimicking residual or recurrent tumor or abscess resulting in additional diagnostic studies and surgical procedures.
  • Immunological reactions. These devices are made of products rerived from porcine and bovine gelatin or collagen. Some patients are allergic (emphasis is mine) to these animal-derived materials.
  • Adhesion formation. These devices, in the presence of coagulated blood and tissue fluid, can often lead to scarring and adhesion formation in the weeks and months (emphasis is mine) following the surgical procedure. The procedure itself can result in additional scarring and adhesion formation.
  • Failure to be absorbed. These devices are readily degraded by emzymatic and hydrolytic action. They may be implanted in an area with low emzymatic and hydrolytic activity. In such instances, it may not be efficiently absorbed. Subsequently, it may become incapsulated and exert pressure or create a chronic granulomatus inflammatory reaction on surrounding soft tissue to cause necrosis or injury, requiring surgical intervention.
  • Interference with Methylmethacrylate Adhesives. Some types of these devices have been reported to reduce the strength of methylmethacrylate adhesives used to fixate orthopedic prosthetic devices to bone.
  • Aspiration into Blood Salvage System Filters. Fragments of these devices may pass through blood salvage system filters and occlude the systems or patient’s vasculature.
  • Embolization. These devices used near moderate to large blood vessels may result in embolization of the blood vessel (which has a high mortality rate).Embolization has been associated with severe adverse effects, including fever, duodenal and pancreatic infarc, embolization of lower extremity vessels, pulmonary embolization, splenic abscess, necrosis, asterixis, and death.
  • Paralysis/Nerve Damage/ Tissue Necrosis.These devices absorb fluids and swell to varying degrees, up to 40 times their weight in volume. The device swelling can encroach on surrounding nervous tissue to cause paralysis or tissue necrosis.
  • Disease Transmission. These devices are composed of animal-derived collagen-based materials, which may carry a risk of transmitting infectious disease when improperly collected, stored, or manufactured.
  • Adverse Tissue Reaction. These devices may result in local or systemic adverse tissue reaction due to material composition or interaction of the material with the body.
  • Toxicity. These devices may contain materials or ingredients that result in local or systemic toxicity.

FDA claims that the following Special Controls would mitigate the risks to health and provide reasonable assurance of safety and effectiveness for absorbable collagen-based hemostatic devices.

  • Material source information must be sufficient to demonstrate that the likelihood of the risk that the device is transmitting infectious diseases is minimized.
  • Material processing information must detail all reagents used in the manufactur of the device, and residual amounts must be quantified.
  • For crosslinked devices, the density of crosslinks must be provided.
  • Device related particulates must be characterized.
  • Collagen characterization information, including elemental analysis and decellularization efficiency determination, must demonstrate the identity, purity, and quality of the collagen.

FDA was unable to provide any evidence or science in the Executive Summary- or when pressed by the panel- on why they proposed down-classing absorbable collagen-based hemostatic agents from Class III High Risk classification, down to Class II with Special Controls. Class III devices are considered “life sustaining” or “life saving” and have the highest amount of FDA oversight. The panel was not provided any evidence as to their reasoning and when the panel questioned this, we were told that information is “confidential”. FDA put us in a bad position because we can’t make a recommendation on something we were not shown and essentially, FDA was asking us to just take their word for it. The discussion got heated about that. We as a panel cannot- and neither should the FDA- use anecdotal evidence over scientific evidence. The only evidence provided to us were two premarket approvals which stated that there is no difference between the device and the control. It should also be noted that absorbable hemostatic agents have remained in Class III for 42 years.

FDA also stumbled on their answers to panel questions and were visibly uncomfortable that they couldn’t.

Absorbable collagen-based hemostatic devices come in powder, paste, sheets, and sponges and are made from porcine or bovine byproducts. This raised a concern from another panel member about those who cannot consume those products due to religious or cultural reasons, as well as for diabetics who often switch from porcine to bovine insulin (and vice versa). It was suggested by the panel member to include the ingredients on the labeling as part of the Special Controls.

Because FDA provided no evidence and no reasoning for down-classing the devices, we adjourned 4 1/2 hours earlier than planned. Most of the morning was spent discussing the lack of evidence and that we are put in a bad position by making a decision on so little information.

Points we could unanimously agree  upon is:

  1. Whether FDA should consider a validated bleeding scale to be used to demonstrate effectiveness of hemostasis. We felt that there needs to be some objectivity and standardization and we unanimously voted yes.
  2. Whether the panel agreed with FDA that absorbable collagen-based devices are not life supporting or life sustaining. We unanimously voted no– that the panel disagrees with FDA on that question.

That said, in a surprising vote about whether to keep these devices at Class III (life saving or life sustaining) or whether to down-class them to Class II following a heated discussion, I was the only panel member to vote no on down-classifying the devices and remaining firm that these devices should remain Class III.  The patient representative abstained from the vote stating that he will deflect to “the experts on this”. All other panel members voted to down-class to Class II. I was shocked considering that we unanimously agreed that these device are, in fact, life saving and life sustaining, that the vote was markedly different than the discussions leading up to it.

In a nutshell, the rest of the panel decided to just take the word of the FDA that they’ll do the right thing with the information that was not presented to us by reason that it’s “confidential” or that FDA “just didn’t think to bring that information and in hindsight, should have”

I’m extremely uncomfortable with that.

 

 

 

FDA Breast Implant hearing- A Consumer Representative perspective

Disclaimer: Views in this post are my own and does not represent the views of the FDA.

On March 25 and 26, the Food and Drug Administration held a hearing regarding the benefits vs. risks of breast implants indicated for breast augmentation and reconstruction. The Advisory Panel was tasked with making recommendations regarding:

  • Breast implant associated anaplastic large cell lymphoma (BIA-ALCL)
  • Systemic symptoms reported in patients receiving breast implants
  • The use of registries for breast implant surveillance
  • MRI screening for silent rupture of silicone gel filled breast implants
  • The use of surgical mesh in breast procedures such as breast reconstruction and mastopexy
  • The use of real-world data and patient perspectives in regulatory decision-making
  • Best practices for informed consent discussions between patients and clinicians.

 

As a Special Government Employee (SGE) for the FDA, I served as Consumer Representative for this hearing. This blog post is my perspective as the Consumer Representative on the panel.

Advisory panels typically have 20 members, made up of FDA staff, physicians, an industry representative, a consumer representative, and a patient representative. My role as Consumer Representative at the FDA is to analyze scientific data, represent the best interests of consumers, and make recommendations to the FDA about changes that should be implemented.

The list of speakers has 81 names on it. Over 2 days, it was 4 hours of testimony from breast implant victims, survivors, surgeons, and public health organizations. That so many people traveled to Silver Spring, Maryland for this hearing on their own dime to speak about the harm of breast implants is very telling.

At the two-day hearing, there were presentations from patients, the FDA, and device makers Allergan, Mentor, Sientra, and Ideal. As Consumer Representative, I can ask questions to the FDA and to the device makers. The panel Chairman did not call on me or the Patient Representative when we wanted to ask questions. During the break, we asked to speak with him privately and told him it is not acceptable to ignore the representatives if we had questions or comments. He apologized and did call on us when we raised our hands after that.

One of the issues I raised after analyzing the data on textured implants causing lymphoma was that textured implants should be removed from the market. Over 30 other countries have removed them from the market due to the risks, yet the United States has not taken any such action. Some panel members took issue with my comment about removing it from the market, stating that “we should not be making knee jerk decisions like that”. I disagree. The science is there. The link between textured implants and Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is obvious. There’s nothing “knee jerk” about it.

Let me clear about something: BIA-ALCL is NOT breast cancer. It is a man-made cancer specific to textured gel breast implants. So women who survive breast cancer and opts for breast reconstruction is potentially signing up for yet another cancer. Let that sink in.

BIA-ALCL is often called “rare”. It’s not rare. It’s that it isn’t clearly understood, the surveys used to track data are long, patients are suddenly dropped from studies, and patients are often not informed properly.

The panel also discussed adverse event registries. While I think they’re a good idea, there are too many. It makes it confusing, there are different parameters for each one, and they are exclusionary. Current registries contain information for new surgeries and re-operations. That excludes a large population of women who are in limbo because they can’t afford explants, and if information is excluded, you’re not getting accurate data. They are based on voluntary reporting, and not on medical records. In addition, Breast Implant Illness (BII) is not included in registries so the data is incomplete. My recommendation to the panel was to have a centralized registry that anyone can have access to. Current registries do not make data available to patients. It does a disservice to patients when information that should be transparent is withheld; otherwise, there is no informed consent. I also recommended that registries include Breast Implant Illness. I also feel that registries should be linked with electronic health records. The current system is based on diagnosis, not on the complete picture of symptoms.

The device makers claim that they provide information and checklists. However, patients are not getting that information – a point made by almost all of the speakers. When the issue was raised during panel deliberations, Mentor later provided a booklet with two pages bookmarked. Not everyone on the panel got the booklets so some of us had to share. This made me uneasy so I snapped photos of the booklet and the bookmarked pages. My instincts were right. I got to look at it but the Industry Representative held on to it. It’s a 70+ page booklet with a checklist that is insufficient. 70+ pages is a lot to read, information is buried, and most concerning is the fact that patients never see it. The booklets are given to physicians, not patients.

After seeing this, I made the recommendation to the FDA that the FDA, device makers, and patients have an equal seat at the table to devise a checklist that is succinct, clear, transparent, and to make it mandatory that patients and the physician sign off on each checklist point. These materials also need to be made available at a consultation prior to surgery, not on the way to the operating room. I asked a Mentor representative for her business card after she said she was willing to have such a meeting. If they don’t keep to their word, they need to be held accountable, and the FDA needs to be held accountable if they don’t implement this recommendation. If patient safety is truly the priority they say it is, true transparency and equal seating at the table needs to happen.

The FDA has hidden hundreds of thousands of incident reports regarding breast implants. An investigation by International Consortium of Investigative Journalists revealed that the FDA has allowed device manufacturers to bury adverse event reports using a program called “alternative summary reporting”.

Two days later, FDA Commissioner Scott Gottlieb announced that the FDA will release old data, stating that full disclosure is a priority.

Shortly before the hearing, the FDA sent warning letters to Mentor and Sientra- breast implant manufacturers stating non compliance with post market surveillance. My question is this: After the FDA sends warning letters, have they ever recalled a device? To date, the answer is a resounding no. That needs to change.

Also of note, ingredient lists for breast implants are not made public. Think about that. The food you eat, the beverages you drink, the supplements you take… they all have ingredient lists. A consumer can decide whether they want to consume those products because the ingredients are available. This is not the case with medical devices.

Breast implants are causing autoimmune and other breast implant illness symptoms. If a consumer knew what was in the implant, you add another layer of informed consent. These implants contain heavy metals,  neurotoxins, carcinogens, and other harmful ingredients. Wouldn’t you want to know that? In addition, knowing what is in the implants can help during the screening process (which is also lacking).

Speaking of screening…

There is none prior to implant. Post-implant surveillance is lacking.

The panel deliberated on the use of MRI screening 3 years after implant and every 2 years after that. MRIs are expensive and not covered by insurance.

The patients who suffer with Breast Implant Illness all stated that their symptoms disappeared after explant. Explant surgeries are not covered by insurance. By mandating pathology after implants, insurance would cover it. The FDA wants to eliminate MRIs as post-implant surveillance because of non compliance from patients. If MRIs were covered by insurance and were not so expensive, there would be more compliance.

Alternatives were discussed during the panel deliberations. One was mammograms. I had to make sure I heard that correctly because I couldn’t believe this was even being suggested.

If you’re a woman who has had a mammogram, you know how it feels to have them. Now imagine having breast implants which are prone to rupture. Squishing breasts in that torturous contraption only puts women at more risk of rupture. Mammograms to test for ruptures are the very thing that could rupture them. And these were suggested by physicians. I’m no doctor but it’s one of the most ridiculous suggestions I’ve ever heard.

Ultrasounds could be a feasible option, but again, if MRIs were covered, we wouldn’t really need to have that conversation.

Deliberations also brought up the use of surgical mesh for implant surgery. In February 2019, the FDA held a hearing on the use of mesh, at which dozens of patients came forward with their stories of harm. Mesh for breast implant surgery is mostly for aesthetic purposes, and patients are not told that surgical mesh will be used during their surgery. Considering how harmful surgical mesh is, you’re adding insult to injury since both mesh and breast implants are causing enormous harm.

Mesh and breast implants are classified as a Class III medical devices. Class III are considered high risk devices. They must be life-saving or life-sustaining and include devices such as artificial heart pacemakers.  Any device in this category requires only one clinical trial as part of the pre-market approval process. The testing must provide evidence that the device is reasonably safe and effective. Mesh and breast implants should not be Class III devices, and need to be reclassified as Class II. And as a side note, if you are harmed by a Class III device, you cannot hold the manufacturer accountable.

The FDA has the authority and responsibility to protect patients. I call on them to take patient testimony to heart and implement the patient safety recommendations that I, and others on the panel, brought up.

The women who have implants deserve better.

To watch the hearing:

Day 1: March 25, 2019

Day 2: March 26, 2019

 

For more information about how screwed up the system is for medical implants, watch The Bleeding Edge on Netflix.

 

 

 

 

 

 

Improved Medicare For All: It’s Time to Change Healthcare to a Single-Payer System

If you’ve never heard of Health Care Justice North Carolina, you’re about to hear a whole lot about it.

I’ve been active in healthcare issues for a little over a decade, one of which is Medicare For All; single-payer national health insurance. As of January 17, I’m the newest member of the Legislative Committee.

It’s the perfect marriage for me. I am a harmed patient with high medical bills, I do national advocacy, and I’ve worked with local, state, and Federal government agencies to affect change.

Health Care Justice NC is the Charlotte, North Carolina branch of Physicians for a National Health Program. PNHP is a non-profit research and education organization of over 21,000 medical professionals and members of the general public who support single-payer national health insurance. If you also support this, please consider signing the Chapter Resolution.

Here is a quick rundown to put single-payer health insurance in perspective:

  • Problem: The United States spends twice as much per capita on health care as other industrialized
    nations, yet we rank near the bottom in nearly all health indicators. Additionally, each year, one trillion of our healthcare dollars go to administrative costs (31%).
    Medicare For All: Having a single payer system– like Medicare– can cut administrative costs in half,
    saving $500 billion dollars annually.
  • Problem: Thirty million Americans have no health insurance. Forty million are underinsured..
    Medicare For All: The savings alone are more than enough to cover all Americans’ healthcare with no co-pays or deductibles.
  • Problem: Most U.S. household bankruptcies are due to medical bills; most households had insurance.
    Medicare For All: Funding for Improved Medicare for All will be less than current healthcare costs for 95% of U.S.households.

Why this is personal: I have several illnesses that require a lifetime of monitoring, tests, and expensive prescriptions. Hospital stay and surgery costs cut into our savings, like many Americans.

 

I remember one surgery in particular… The hospital was covered by my insurance and my surgeon was covered; my anesthesiologist wasn’t. I got a huge bill that I was expected to pay out of pocket. When I called the insurane company to appeal it, I said, “Was I supposed to bring my own anesthesiologist??”

Another example is a blood test I need to monitor my blood disorder. This test explained why my blood counts were so low and how my doctors can treat my condition. The insurance company called the test “experimental” (it’s not. It’s a standard test that is well known) and refuses to cover it. My primary doctor and hematologist were furious when I brought it to ther attention. They both submitted paperwork explaining why it is medically necessary. I’m still battling the insurance company over this.

My medications are costly. I’ve had to decide between paying mortgage and utility bills or paying for medications. I’ve had to either ration medicine or decide not to fill it out of fear of running out of money.

And remember, I am insured. I fall into the category of underinsured.

There are a lot of people like me who can’t pay medical bills under the current system. Improved Medicare for All warrants a lot more discussion and finding ways to fix a broken system.

This is something I’m passionate about and you’ll be seeing a lot more of me as I lend my voice to affect change.

 

 

 

 

The Bleeding Edge Documentary on Netflix

I met The Bleeding Edge documentary film makers Kirby Dick and Amy Herdy in February 2016 in Washington, DC. They were making a film about medical harm.

Their film The Bleeding Edge debuted today, July 27, 2018 on Netflix. It exposes the horrors of the medical device industry. Click on the image below to watch it.

(I make a brief cameo in the film)

I’ve been a patient advocate since approximately 2012. This happened accidentally because I was harmed in 2006 by Cipro and Levaquin, both fluoroquinolone antibiotics made by Bayer and Johnson & Johnson respectively. In the last twelve years I’ve had over two dozen surgeries to repair the damage caused by a medication that was supposed to help me. Antibiotics that carry extreme risks, that the risks outweigh the benefits, and that I was never warned about. The information regarding risks were hidden until advocates across the globe came forward to expose them, including myself.

It was advocacy that led to several changes in the warning labels. We were on  mission to hold Bayer and Johnson & Johnson, as well as the FDA, accountable. Although they still maintain that these drugs are safe and effective and they stand by their products, they did make changes because it became clear that their own data proved what advocates knew all along, and they could not deny the risks any longer.

The more I got involved in advocacy, I was invited to workshops and conferences. There I met advocates from the medical device side of advocacy. I saw that it isn’t just a flawed system in the approval and marketing of pharmaceutical drugs, it was also flawed in the approval and use of medical devices. It is an entire system that is designed to fail.

One workshop that I attended was in Washington, DC where I attended a training session led by the National Center for Health Research. This workshop changed the trajectory of my advocacy. I learned about the approval process, how drug companies use smoke and mirrors to market drug commercials, and how loopholes are created that make it hard to navigate. While there, I had the honor of being on a panel to discuss how advocacy leads to changes at the FDA. On that same panel is Angela Desa, who is featured in The Bleeding Edge documentary.

 

The training proved to be invaluable. Not only did I receive training that helps me in my job and in my advocacy, but I met medical device advocates who breathed new life into my own advocacy. Breast implant awareness advocates, mesh injury awareness advocates, and the incomparable E-sisters who raise awareness about the Essure medical devices, and who fight to create legislation to make medical devices safer.

Meeting them solidified my decision to advocate for all patients harmed by pharmaceutical drugs and medical devices. It gave me a complete picture about the flawed system as a whole and I felt compelled to be part of the solution by being on the policy end.

In 2016, I became a Special Government Employee (SGE) for the Center for Devices and Radiologic Health (CDRH) at the Food and Drug Administration.

I was chosen for two device panels, but under CDRH policy, I can be borrowed and called to serve on any panel under the CDRH umbrella.

Recently, I served as Consumer Representative on an advisory panel to discuss the safety and effectiveness of a cardiac device, and the risk vs benefit profile. My job is to represent consumers and raise concerns about how the particular device can affect patients. I analyze data that I must keep confidential, I ask questions to the device makers and to FDA investigators, listen to testimony from the public hearing portion of the hearing, and express input from a patient safety perspective. At the end of the hearing, before the panel vote, I can sum up what I brought up during deliberations and make recommendations to the FDA and device makers on how to incorportate patient safety. The panel then votes on whether to advise on further steps. In this case, some of the advisory committee recommendations made me happy because the risks did prove to be alarming and steps will be taken to make vital changes. Other parts infuriated me, such as when it was agreed by the majority of the panel that it should be left up to surgeon discretion as to whether the device should be used. With the exception of me, the Patient Representative and the Industry Representative, the voting panel was made up of all surgeons who use the device.

That all said, I watched the Bleeding Edge today and as a harmed patient, a patient advocate, and an SGE with the U.S. Department of Health and Human Services, I have some thoughts on it.

While I know a lot about the approval process of medical devices, and I know people harmed by the devices, the film is shocking. The depth of profits over patients is stunning. And the collective voices of the patients who bravely told their story is inspiring. This film is necessary and helps viewers understand how it came to be that this is allowed to happen, and why the voice of harmed patients and advocates can be a powerful force for change.

The film should serve as a wake-up call to everyone: patients, physicians, device manufacturers, and the FDA.

As an advocate, I’ve experienced push back by the industry, and it can be overwhelming. It can make you feel crazy because no one is listening to you, or they are dismissing your symptoms and pain calling it “rare” or “just part of the illness, not the device/medicine”. You become conditioned to think it’s all in your head. The thing is, can it be all in your head when so many people are coming forward with horrific stories of harm? That’s hard to ignore when people around the world are experiencing harm that they were never told about, and in the name of so-called “innovation”. Even harder when all the adverse events that have been reported are only 4 to 5 % of the total amount so the rest of the 95 to 96% are people suffering in silence. Adverse events are “voluntary reporting” by patients. Doctors who become aware of the adverse events are not required to report it. Only industry is required. Except that there is no incentive to do so when they have a stake in its usage and sales. When patients do report adverse events, they are dismissed with phrases like ” You’re not a doctor so what do you know?”. Actually harmed patients know a lot more than anyone. Just saying.

I was at Johnson & Johnson a few years ago to talk about my story and how I am now disabled from Levaquin. Before I was even allowed up to the microphone, I had to be approved by the “mic keepers”. I was given 3 minutes to speak to CEO Alex Gorsky and the shareholders in attendance.

My microphone was cut off and Mr. Gorsky went into a monologue about how safe Levaquin is and how the company stands by their product. How Johnson and Johnson stands by their Credo, which, honestly, is a crock of sh**.

As someone who held a ticket to attend, My. Mike. Was. Cut. Off. And I was not quiet about that.

The year after, I met with Johnson & Johnson for the second time, where again, Alex Gorsky was in attendance. This time, I was thrown out by security. Twice. My dad was with me and he still thinks it’s equal parts hilarious and ridiculous. And it’s all on tape. These meetings are recorded. I wasn’t quiet about that either.

I’ve also been on both sides of the FDA process. I’ve testified at hearings as a harmed patient, and I’ve also sat on advisory panel meetings.

My advocacy and my work at the FDA gives me a complete picture of the approval process, and how Black Box warnings work. The combination of all of that experience came together when I watched the Bleeding Edge documentary.

The things that pharmaceutical drug and device companies get away with should be criminal. But it’s not. The film delves into how the exception became the rule and how loopholes were created by industry, the FDA, and Congress that allows this level of harm come to patients.

Did you know that if a device is recalled because it’s dangerous, that a device company can still get their version of that risky device approved because of the 501K pathway created by Congress? Ninety eight percent of devices are approved based on the 510K process, and based on previously recalled devices that are proven risky. Only in the pharmaceutical, medical device, and regulatory agency industries can this be allowed to happen.

Did you know that most physicians are not aware of the risks involved in the device they are implanting? They figure that the FDA takes care of that part of it. It does not.

Did you know that a representative from the device company is present during your surgery to implant the device and that you don’t have to be told that an unqualified, non medical professional salesman is watching your surgery? I have several medical devices implanted as a result of the pharmaceutical harm I’ve suffered over 12 years. Not once was I told about this. Or what the devices are made of. Or that it was untested. Or that I could have an allergy to the materials the device is made of.

I wasn’t told anything when I was going through medical harm. But thanks to the Bleeding Edge documentary, you can be.

It is vital- even life saving- to have ALL the information so that you can make an INFORMED decision about your health.

Thank you to Kirby Dick, Amy Ziering, Amy Herdy, for exposing the dangers of medical devices and to the brave advocates who shared their stories. Y’all saved lives and you are my personal heroes.

 

 

FDA fails to finalize proposed rule about generic medications- Still

On March 27, 2015 – three years ago today – I testified at the Food and Drug Administration about proposed labeling changes on generic medications.

Finalizing this rule would open the door for patients who are harmed by generic medication the right to sue the generic drug manufacturer. This is because of a 2011 Supreme Court decision called Pliva v. Mensing.

Gladys Mensing and Julie Demahy were prescribed Reglan in 2001 and 2002 respectively. Instead of receiving Reglan, they were given its generic version metoclopramide.

They both developed tardive dyskinesia, a serious, non-reversable neurological disorder. As evidence mounted, the drug’s warning label was altered in 1985, 2004, and 2009. The 2009 label instructed that use of the drug beyond 12 weeks “be avoided in all but rare cases.”

Mensing and Demahy sued the manufacturers of the generic drugs they had taken. They alleged that the manufacturers were liable under state tort law for failing to provide adequate warnings. The manufacturers pleaded preemption as an affirmative defense, contending that because federal law required them to use the same label as Reglan, it was impossible to comply with a state-law duty requiring a different label.

The generic manufacturers moved to dismiss on implied pre-emption grounds arguing that:

1) FDA regulations require the warnings on generic pharmaceuticals to be the same as those of the brand-name product.

 2) They had no ability to unilaterally add or strengthen warnings without FDA approval. As a result, the manufacturers argued that plaintiffs’ failure to warn claims were pre-empted because it was impossible for them to unilaterally add the plaintiffs’ proposed warnings without violating FDA regulations.

The U.S. Supreme Court decision represents a landmark victory for generic drug makers on the issue of federal pre-emption. By a 5-4 majority, the Supreme Court held that state law failure to warn claims against generic pharmaceutical manufacturers are impliedly pre-empted by federal law. In reaching this decision, the court accepted the Food and Drug Administration’s interpretation of its own regulations that generic manufacturers are legally prohibited from unilaterally changing or strengthening their product labeling without prior FDA approval. This deference to the FDA paved the way for the court’s holding. The court held that because it was impossible for a generic manufacturer to unilaterally add or strengthen warnings without violating FDA regulations, all state law failure to warn claims are pre-empted.

A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics. And they are significantly less expensive than its brand name counterpart.

Eighty percent of medications dispensed are generic. And if you are harmed by a generic medication, you cannot sue the manufacturer. There is no justice for those patients.

The Food and Drug Administration proposed a rule to change warning labels, which would open the door to those patients to receive justice.

I testifed at the FDA to urge them to finalize that proposed rule.

 

Those injured by generic drugs have suffered the same injuries and disabilities as those who took brand name medications and justice has been denied because of the current generic drug safety loophole.

The FDA has the power and responsibility to ensure patients are warned and to promote safety by making sure generic drug makers are accountable for their products just as brand name-drug makers are. By not finalizing the proposed rule, it is only adding injury to injury and leaving patients at risk.

An FDA decision has been postponed several times.

It has been three years and the FDA continues to fail to finalize the proposed rule.

Three. Years.

Salesman caught lying to sell water system in Charlotte, NC: Hidden camera investigation

Hidden camera investigation: Action 9 catches salesman lying to sell water system in Northeast Charlotte.

http://www.wsoctv.com/news/9-investigates/hidden-camera-investigation-action-9-catches-salesman-lying-to-sell-water-system/642238505

It all started when I found this hanging on my mailbox.

Aquafeel Solutions said that our entire neighborhood’s water was contaminated and that they were offering free water tests to all homeowners in the neighborhood.

I was immediately suspicious and began doing some online research on the company.

It turns out that this scam was already reported in Tampa, Florida and Tega Cay, South Carolina.

Complaints about this company have been reported for years.

I then checked the Better Business Bureau website and it reports that the company had their accreditation revoked.

Aquafeel Solutions claimed they got permission from our HOA to test our water. I was suspicious of this also, so I contacted my HOA with this e-mail:

I contacted WSOC-TV Action 9 investigative reporter Jason Stoogenke and asked him if the station has heard of the scam here in Charlotte, NC. I’ve worked with Jason before about my work in patient safety and public health. I sent him the links I found about the scams in Florida and South Carolina.

At that point we didn’t know if there was any kind of fraudulent claims being made here in our area. Jason told me prior to the cameras being set up, “Maybe there’s something there. Maybe there isn’t. Let’s find out”.

WSOC-TV set up four hidden cameras in my house and set up other cameras to film.

 

Find out we did.

Jason and a cameraman were upstairs listening in and watching the hidden camera footage on a monitor.

In a period of 75 minutes, the sales rep made over 50 false claims.

Too many to post but here are a few:

  • Claim: Our water is supplied by Lake Catawba. This is false. There is no Lake Catawba.
  • Claim: Charlotte water ranks worse than Flint, Michigan water. This is false.
  • Claim: Brita filters only removes lead. This is false.
  • Claim: White in your ice causes kidney stones. This is false.
  • Claim: Heroin is found in Charlotte water. This is false.
  • Claim: Aquafeel is a division of NASA and their filtration system is used by astronauts. This is false.
  • Claim: Your skin can absorb all the toxins in your drinking and bathing water in 30 seconds. This is false.
  • Claim: You bathe in feces laden water every day. This is false.
  • Claim: McDonalds and Starbucks use their filtration system. This is false.
  • Claim: You won’t ever have to clean your toilets with this system because the water will be so purified. This is false.
  • Claim: You will see a guaranteed 29% off your gas bills if you install their system. That clean water heats faster. This is false.
  • Claim: The water is sent to your local water treatment center. That water is sent right back to you; you don’t have new water. This is false.

He even did a little magic trick in my kitchen. He had me fill two bowls with water. He added a chemical to one bowl, used a metal spoon to stir it, and the water turned orange. He said that the chemical he added tests for the chemicals Charlotte Water Utility uses to clean city water. Then he had me put my hand in the other bowl for 30 seconds, and then he added the same chemical. It stayed clear. He told me that my skin absorbed the contaminants and therefore the water stayed clear. I should mention that this is a science trick my dad taught me as a little girl. Ions mix with pH and alkaline causing the water to turn colors. My dad was a chemical engineer and I have a background in science. At no time did Aquafeel Solutions actually test for contaminants in my water. In fact, when I asked them to, the salesman said that we were “overthinking this” and refused to do any further testing.

The salesman said that military personnel and government employees get a discount on the $7,000 water filtration system. When I told him I work for the U.S. Department of Health and Human Services and I’ve done work with the FDA and CDC, he got visibly nervous.

In addition, the salesman again repeated that he got clearance from my HOA. This is the response I got when I emailed the HOA to ask them about it. They did not authorize any water tests and said they will be reporting this to the proper authorities.

 

When the salesman left, the reporter came back downstairs and kept shaking his head. He had a lot of claims to fact-check. Before he and his crew left, we took a group photo.

WSOC-TV fact-checked the claims which can be found here and here. They contacted Charlotte water, my HOA, a urologist, Delta faucets, UNC Charlotte, McDonalds, Starbucks, NASA, U.S. Department of Energy, the Internal Revenue Service, the U.S Department of Environmental Quality, and North Carolina Attorney General Josh Stein.

They also contacted Aquafeel and the salesman to get a statement from them.

WSOC-TV came back to my house on October 27, 2017 to do an on-camera interview with me.

  

  

The story aired on November 9, 2017. Jason Stoogenke came to my house again to film the intro live in front of my house, at my mailbox where this all started.

Bottom line: Always do independent research when a company tries to sell any product to you. While there are good companies out there, there are also fraudulent, predatory ones. By having all available information, you can make an informed decision about what is right for you and your home.

Sepsis: This time it’s personal

Throughout my years in patient safety, I’ve been to many meetings, conferences, and summits. In those years, I’ve been introduced to patient safety leaders involved in reducing sepsis and raising awareness about it. Being in the field of antibiotic safety, my work often crosses with advocates regarding infection control.

I have these people to thank for saving my life.

I have to admit, prior to meeting them, I didn’t know what sepsis even was. But one thing that always stuck with me after the meetings was the phrase “Could this be sepsis?”.

I just found out how asking that question could save your life.

Let me back track a bit and explain how this became personal for me.

I broke my ankle in 3 places and ruptured 5 tendons. Repairing it required extensive reconstructive surgery. I had three incisions. Two weeks following the surgery, I developed an infection. The incisions were blistery, peeling, red, swollen, and leaking some kind of fluid. In addition, I had a very high fever. Taking the advice of a nurse friend, I had it checked out and I was treated for infection.

I didn’t give it a second thought until one day after physical therapy a few weeks later. Later that night, my ankle was red, swollen and leaking. I wasn’t alarmed about it until I had the chills so bad that it looked like I was having a seizure. My breathing and heart rate became rapid and I was hallucinating.

This felt different than the last time I developed an infection.

I went to Carolinas Medical Center in Charlotte, North Carolina.

I remembered that crucial phrase from my meetings, “Could this be sepsis?”

I didn’t realize I’d said it out loud until someone said “Yes, it could”.

Code Sepsis was called.

For those who don’t know, Code Sepsis is a protocol in which a patient is given fluids and antibiotic therapy within three hours of triage. For their compliance with Sepsis protocols, Carolinas Healthcare System was named a 2015 Sepsis Hero by the Sepsis Alliance.

I met several people from the Sepsis Alliance over the years. Thanks to the protocols they helped implement, I survived sepsis. It is not lost on me that I developed- and survived- sepsis during the month of September, which is Sepsis Awareness Month.

From what we can piece together, one of the three incisions was not healing properly and it opened me up to infection. I contracted MRSA at a physical therapy facility. It then turned into Sepsis. Luckily it was caught early and I was home within the week.

For more information about sepsis and the Sepsis Alliance, click here. It may just save your life. It saved mine.