Charlie was a mystery. He didn’t actually live in the house next door, but he was there a lot. John once told me that the lady who owns the house and Charlie “got a thing going on.”
“Me…and…Mrs. Jones…,” He whistled through his missing teeth as he looked at me with a grin.
I knew Charlie was a veteran because he usually wore a cap from the Stand-Down, an annual event designed to help homeless veterans get off the street. Stand-Down was a place to get a haircut, get an ID issued, and find work and possibly even a place to live. Many veterans have been helped by this program, but too many others appear year after year, never able to keep it together for very long, looking only for a sandwich and an afternoon of hope.
Charlie didn’t fit the image of the troubled veteran, and I assumed that he volunteered to help out at the Stand-Down, as many veterans did. He was always well-kept, healthy, sharp and happy. He was tall and handsome, gregarious, and full of booming laughter. The residents next door seemed to love him, so it was great to find Charlie hanging around and lifting their spirits.
One evening some of the guys were sitting on the front porch next door. Mrs. Poole was in the slow process of wheeling herself in the front door, but stopped long enough to wave as I walked up.
“…’night, Mrs. Poole,” I said as she went through the door.
“Goodnight, Michael,” I heard from behind the big door as it slowly closed.
It was a sweet spring evening, and after exchanging greetings with everyone and some small talk with John, we all fell quiet and watched the cars alternate through the four-way stop in front of the house. Most had their headlamps on, others just parking lights. In the last bit of thin grey light still left in the day, the flowers in the yard looked almost real.
Charlie broke the silence.
“Did I ever tell y’all about the monkey I used to have?”
“MONKEY?” John asked, as if he’d misheard.
“Yep,” answered Charlie, “monkey.”
“Hell no, you haven’t told us about no damned monkey,” John replied, as if he didn’t believe it for a second.
“Hey, this is no bullshit,” Charlie said, feigning indignation.
“Ok, ok…” John surrendered, “Let’s hear it then.”
And Charlie started telling us about the monkey he once had, and all the things they used to do together, how much he enjoyed the monkey, and how he grew to love the monkey more than anything in the world. As Charlie talked, I could tell that John was becoming interested in the story. I’m sure he expected that the monkey would meet some horrible end, and seemed anxious to hear the gruesome details.
Charlie continued that he accidentally locked himself in the tool shed one time, and there was no one around who could hear him. It started getting dark, and he started to get a little scared being locked in that shed when he suddenly felt something on his back.
“It scared the daylights out of me. I jumped around, and you know what that was on my back?” Charlie asked us.
“That goddamn monkey,” John answered.
“The monkey, “Charlie continued as if he hadn’t heard, “and you know what?”
“What?”
“That monkey was alcohol, my brothers, and you better not let that monkey get on your back if you know what’s good for you” he finished with a stern look at each of us. A moment passed, and Charlie let out a roar of laughter as the rest of us realized that we’d been had.
“Son of a bitch,” John shot back, “I knew you were full of shit.” “Here I was all worried about the goddamn monkey,” he continued, “and the whole time you are giving us a goddamn A.A. lecture.”
Charlie was pleased with himself, and John had a laugh too. In the banter that followed Mr. Teeter asked, “What happened to the monkey?”
John leaned toward Mr. Teeter and lowered his voice a bit, “There was no monkey, Andy. That asshole Charlie is telling us a bunch of bullshit again.”
By that time it was too dark to see the expression on Mr. Teeter’s face, so I never knew if he got it or not, and I didn’t see Charlie again for a while after that. I didn’t see him again until Memorial Day.
My upstairs apartment in the house next door had virtually no insulation, so I could hear every car that passed and practically anything that happened outside, even with the volume turned up on the Aldo Ray movie I was watching.
I thought I heard something. I turned off the sound and listened. There was nothing. I turned the movie back up and heard it again. Volume down, I heard this time very clearly someone calling out my name from outside the house. I sometimes had friends get my attention upstairs that way, but this was different.
As I got up and went to the window, I guessed it was going to be someone from next door since there was a lot of drama over there. I was surprised to see Charlie shit-faced drunk and crying like a baby on the sidewalk out front.
“Can I come in, Mike,” he said in tears.
“Uh, sure Charlie…I’ll be right there,” and I went down the creaky stairs to the front door and let him in.
Once back upstairs, I got a good look at his face in the light. He appeared to have been crying for a long time tonight. His eyes were bloodshot and his face was puffy and streaked with tears.
“You need a beer?” I asked, although he’d obviously had plenty. He nodded, and I went to the kitchen. When I returned, he was sitting in the chair with his face in his hands, sobbing.
What’s the matter, Charlie?”
He didn’t respond.
I held the beer can out to him. He looked up and took the beer. He popped the top, took a swig, pulled out a handkerchief, and wiped his face. I thought he was ready to talk, but he didn’t say a word. I didn’t either. We sat for a long time in silence, interrupted only by the sound of the cars passing by and the progressively hollow clank of the beer can each time he set it on the table beside him.
He took a breath, and started to speak. He only managed a single word before he broke down again, covering his face with his hands and crying.
After two hours of false starts and beer, he calmed down enough to talk. When he started by saying “back in ‘Nam,” I got the sense that I was about to learn about the real monkey on his back.
He then told me the story.
His unit had been sent to check out a Vietnamese village. They didn’t expect any hostiles, and they didn’t find any. They found nothing out of the ordinary. There weren’t many men of fighting age, but there were elderly people, women going about their daily chores, and a bunch of kids around. The kids ran to meet the soldiers when they noticed the group coming through the village.
For Charlie, those bright faces were like an oasis in the desert; a bit of innocence in a world of filth, corruption and death. As the other soldiers walked on, he stopped and knelt down. Smiling, he put his hand out. Some smiled back at him, and a few cautiously extended a small hand and touched his.
Charlie had been carrying a brand new pack of chewing gum with him for days. He hadn’t opened it because he didn’t really like chewing gum all that much, but he liked having a little piece of home in his pocket.
None of the kids seemed to recognize the green wrapper. He thought some other soldiers might have previously come along and given these kids some chocolate or chewing gum, but he could tell by their faces that he was the first. He knew he would have to show them how.
He peeled off the end of the pack, and slid out a slim stick of gum. After counting the small dark heads, he went ahead and removed the remaining pieces.
He stripped each stick down to its foil wrapper, and split them so that each kid would have a portion. He took the small piece he’d kept for himself and held it up in front of the kids as he slowly peeled the foil away. With some coaxing and a little help, the kids followed suit. He put the gum in his mouth and started chewing. There was no need to coax the kids to do the same.
“I taught those kids how to chew gum,” Charlie said looking at the floor.
A moment passed, and his voice cracked as he muttered to himself, “Why did they do that?”
I was confused.
“Do what, Charlie?”
He then looked up from the floor and directly into my eyes. He seemed to have a moment of clarity, as though he just realized that he was sitting in my living room.
He stared at me, and to be honest, I wasn’t sure what to expect from him next.
“They moved us up a hill the next day,” Charlie said in a low voice, “but we could still see that village a ways off in the distance.”
He heard jets, and looked upward. They saw the squadron in the distance, flying low as it came toward them. Some of the soldiers let out a whoop. They’d seen many times jets in this formation, flying low, on the way to napalm an enemy installation. The squadron roared past.
As the jets neared, Charlie worried that the loud noise might scare the kids. He watched as the jets passed over the village. A heartbeat later, a football-field length of earth exploded into flames, including the village and everything around it. The inferno billowed into the sky, engulfing the tops of trees, as Charlie watched, and in that moment, out of the sweating jungle, a monkey jumped on Charlie’s back. He keeps it on a leash most of the time. He keeps it in check. Only at certain times does it get the best of him, but he’ll never be rid of it. It will never leave.
6.14.2005
The Indelible Blossom of Crazy-House Flowers: Dancing in the Arms of Mamie Eisenhower.
Anyone following these stories knows that I’ve left the blog alone for a while. I would like to claim writer’s block or some other impressive-sounding affliction that strikes creative types, but the truth is that my coping mechanisms are avoidance & denial, and the stories are getting harder to tell. As the years passed, I became good friends with some of my neighbors. These stories are meaningful to me and to tell one becomes a delicate kind of surgery. Mr. Teeter’s story is the first I wanted to tell, but he didn’t make it until near the end of this series.
One evening, late spring, I came out and spotted a group of guys sitting on the front porch next door. Wise-cracking John was there. Brooklyn-raised and manic depressive, he was hilarious during his manic phases, but wouldn’t leave his bedroom for months during his depression. Charlie was also there, loud and good-natured, a mystery since he seemed far too well-balanced to be in this house, along with Michael, a spastic fellow who was later shot dead during a crack deal; Paul, a NYC police officer until he suffered a severe head wound and significant brain damage; and Mr. Teeter, an odd quiet little man who only left the house dressed in a thrift-store coat & tie.
John called me over. “Listen to this…listen…,” he said.
I knew by the tone of his voice that it must be good.
“Ok, Andy, tell Mike this story...”
I looked at Mr. Teeter… Andy. I often passed him on the street and would speak, but he seldom would look up from the sidewalk. I had spoken with him briefly in the yard a few times. It was obvious that he had come here – to this location and to this condition – from some very different place. When he walked down the street in his over-wide tie, his tongue would dart in and out of his mouth, which I understand to be a side-effect of lithium.
All of us fell quiet -- even the gregarious Charlie and wise-ass John -- and turned to Mr. Teeter.
I smiled at this. They’d just heard the story before I came outside, but were all ready for another telling. They had a special reverence for these stories from the past, their stories, the ones that mattered, from a time before now.
Mr. Teeter drew a breath and started timidly, “Well…it was the custom for young officers…”
John cut in, “He was a pilot in World War II.”
“Yes,” Andy confirmed, “but this was before Pearl Harbor…”
“Eisenhower wasn’t a General yet,” added John, wanting to move the story along.
“No, he was a Colonel then, Chief of Staff for General Krueger at the 3rd Army Headquarters in San Antonio,” Andy continued, speaking the most words in succession that I’d ever heard from him.
“It was the custom when we had a cotillion for younger officers to ask the General’s wife for a dance. Guys were lined up to ask Mrs. Krueger. It didn’t matter if she accepted or not. She usually didn’t. It was a custom to ask. It was expected. "
He continued, “But Colonel Eisenhower and his wife were sitting alone. They liked to dance. Besides, we knew that the Colonel would make General one day. He was first in his class at Command School.”
John interrupted, “So you were a brownnoser and all-around asshole, is that the moral to this story, Teeter?”
Mr. Teeter smiled as everyone had a quick laugh and continued, “Well…I could have been just another asshole in line, or the only asshole to ask the Colonel’s wife to dance, so…”
“So…did you?” I asked.
He nodded.
“What did she say?”
“She said,” John chimed in, “that the asshole line is over there.”
Charlie couldn’t resist, and boomed, “The Brownnose line forms at the rear, motherfucker!”
We all laughed, and someone peeked from behind the dark drapes inside the front window. Mr. Teeter laughed the only laugh I ever heard from him, obviously delighted that we were enjoying his story so much.
“She said yes,” he went on, “but as she was getting up from the table, Colonel Eisenhower said, ‘Son, if you’re going to dance with my wife, you’d better treat her as well as I do,’ and I said yes sir I sure would sir.”
He paused, and lifted his face to the sky.
“We danced a waltz. She asked where I was from. She asked about my family and how long since I’d been home. She was nice, and she smelled like lilacs.”
His voice trailed off as we all looked at him.
Then the other guys turned to me, to see, I suppose, if I actually believed the story at all, We were, after all, sitting on the front porch of a group home for Mental Health Co-op patients. Mr. Teeter didn’t look at me though. He looked at the sky, sublime, reliving that moment, a line from a Baudelaire poem, in his melancholy waltz with the future First Lady while music and lilacs turned in the air.
The best I could do was, “Wow. That’s amazing.”
John laughed a triumphant, “Ha!” He had known that I would like that story.
Mr. Teeter, pleased with himself, was ready to talk now.
“I also flew Bobby Kennedy…”
“Yeah, Teeter,” John interrupted, “and that’s a story for another night. You are supposed to be on a cigarette run right now, ya know.”
“Right,” Andy acknowledged. Michael and Paul joined him. He smoothed back his few remaining strands of hair, and headed down the block in front of the other two, tongue darting in and out as he walked.
We watched cars line up at the intersection in front of the house. The sunlight was beginning to drain away as the last of the six o’clock rush hour crept through the four-way stop.
Eventually, Charlie asked, “You believe that shit?”
“I do,” I answered.
A beat passed.
“Me too,” he said.
“Me too,” added John
Two drivers blew their horns and gave each other the finger.
One evening, late spring, I came out and spotted a group of guys sitting on the front porch next door. Wise-cracking John was there. Brooklyn-raised and manic depressive, he was hilarious during his manic phases, but wouldn’t leave his bedroom for months during his depression. Charlie was also there, loud and good-natured, a mystery since he seemed far too well-balanced to be in this house, along with Michael, a spastic fellow who was later shot dead during a crack deal; Paul, a NYC police officer until he suffered a severe head wound and significant brain damage; and Mr. Teeter, an odd quiet little man who only left the house dressed in a thrift-store coat & tie.
John called me over. “Listen to this…listen…,” he said.
I knew by the tone of his voice that it must be good.
“Ok, Andy, tell Mike this story...”
I looked at Mr. Teeter… Andy. I often passed him on the street and would speak, but he seldom would look up from the sidewalk. I had spoken with him briefly in the yard a few times. It was obvious that he had come here – to this location and to this condition – from some very different place. When he walked down the street in his over-wide tie, his tongue would dart in and out of his mouth, which I understand to be a side-effect of lithium.
All of us fell quiet -- even the gregarious Charlie and wise-ass John -- and turned to Mr. Teeter.
I smiled at this. They’d just heard the story before I came outside, but were all ready for another telling. They had a special reverence for these stories from the past, their stories, the ones that mattered, from a time before now.
Mr. Teeter drew a breath and started timidly, “Well…it was the custom for young officers…”
John cut in, “He was a pilot in World War II.”
“Yes,” Andy confirmed, “but this was before Pearl Harbor…”
“Eisenhower wasn’t a General yet,” added John, wanting to move the story along.
“No, he was a Colonel then, Chief of Staff for General Krueger at the 3rd Army Headquarters in San Antonio,” Andy continued, speaking the most words in succession that I’d ever heard from him.
“It was the custom when we had a cotillion for younger officers to ask the General’s wife for a dance. Guys were lined up to ask Mrs. Krueger. It didn’t matter if she accepted or not. She usually didn’t. It was a custom to ask. It was expected. "
He continued, “But Colonel Eisenhower and his wife were sitting alone. They liked to dance. Besides, we knew that the Colonel would make General one day. He was first in his class at Command School.”
John interrupted, “So you were a brownnoser and all-around asshole, is that the moral to this story, Teeter?”
Mr. Teeter smiled as everyone had a quick laugh and continued, “Well…I could have been just another asshole in line, or the only asshole to ask the Colonel’s wife to dance, so…”
“So…did you?” I asked.
He nodded.
“What did she say?”
“She said,” John chimed in, “that the asshole line is over there.”
Charlie couldn’t resist, and boomed, “The Brownnose line forms at the rear, motherfucker!”
We all laughed, and someone peeked from behind the dark drapes inside the front window. Mr. Teeter laughed the only laugh I ever heard from him, obviously delighted that we were enjoying his story so much.
“She said yes,” he went on, “but as she was getting up from the table, Colonel Eisenhower said, ‘Son, if you’re going to dance with my wife, you’d better treat her as well as I do,’ and I said yes sir I sure would sir.”
He paused, and lifted his face to the sky.
“We danced a waltz. She asked where I was from. She asked about my family and how long since I’d been home. She was nice, and she smelled like lilacs.”
His voice trailed off as we all looked at him.
Then the other guys turned to me, to see, I suppose, if I actually believed the story at all, We were, after all, sitting on the front porch of a group home for Mental Health Co-op patients. Mr. Teeter didn’t look at me though. He looked at the sky, sublime, reliving that moment, a line from a Baudelaire poem, in his melancholy waltz with the future First Lady while music and lilacs turned in the air.
The best I could do was, “Wow. That’s amazing.”
John laughed a triumphant, “Ha!” He had known that I would like that story.
Mr. Teeter, pleased with himself, was ready to talk now.
“I also flew Bobby Kennedy…”
“Yeah, Teeter,” John interrupted, “and that’s a story for another night. You are supposed to be on a cigarette run right now, ya know.”
“Right,” Andy acknowledged. Michael and Paul joined him. He smoothed back his few remaining strands of hair, and headed down the block in front of the other two, tongue darting in and out as he walked.
We watched cars line up at the intersection in front of the house. The sunlight was beginning to drain away as the last of the six o’clock rush hour crept through the four-way stop.
Eventually, Charlie asked, “You believe that shit?”
“I do,” I answered.
A beat passed.
“Me too,” he said.
“Me too,” added John
Two drivers blew their horns and gave each other the finger.
2.21.2005
The Indelible Blossom of Crazy-House Flowers: Beryl's Brazilian Divorce
As the seasons passed, the red and yellow plastic flowers on the porch and in the yard around the house began to fade, but only slightly. The residents of the house had not faired quite so well. Too many cold nights had cut them off from the rest of the world, and too many glaring days had rendered them nearly invisible. From my vantage point next door, however, the blossoms could still be seen.
A few of the residents had developmental disabilities, but a number of others had previously led lives that most people would call “normal.” There were veterans from two wars, for instance, and a former police officer. I was always curious about that. What had happened to them? What life-altering event had sent them into mental illness? Or maybe it didn't happen like that at all. I didn't know.
I had a chance to find out one day when I decided to walk to the grocery store.
The residents next door were constantly making trips to the store for cigarettes, beer or a cup of free coffee. Today, Beryl was marching out of the house next door as I headed down my front porch steps. She was dressed, as always, in a very sporty outfit, a definite New England look: cargo shorts, deck shoes, a horizontal-striped top, short cotton jacket and a lavender baseball cap. She turned in the direction of the store. I waited a few seconds, and fell in step beside her.
When Beryl was on a mission to the store, she would walk her deliberate walk and stare at the ground in front of her. Unless someone spoke to her, she would pass right by without ever looking up. It was different if she was trying to scrape up some change for a pack of cigarettes. She was like a heat-seeking missile at those times, but either way, I always spoke to her. Normally, I would get nothing more than an overly-loud “hello!” Sometimes she would add “how you doing?” Today, amazingly, Beryl was in the mood to talk.
It was her son’s birthday. He was twelve years old.
“Where is he?” I asked.
“He lives with his father,” she replied, “in Sao Paulo, Brazil.”
“Really?” I asked, and almost immediately regretted my word choice. I hadn’t even considered that she wasn’t telling the truth; I was just surprised.
“Yup,” she said unfazed, “I used to live in Brazil.”
"Wow." I was genuinely impressed. “How did you end up in Brazil?”
Of course, I really wanted to know how she ended up that house next door.
Beryl, focused on the sidewalk, twirled a strand of hair and told me how she’d met a young doctor, a brain surgeon, back in her home state of Vermont. She gave few details, but went on matter-of-factly, in a voice slightly too loud. Her young doctor was Brazilian. They married, and she moved to Sao Paulo where they had a son.
“But then I got messed up…and they sent me here.”
I had been extremely curious about Beryl, her housemates and how they had gone from relatively normal lives to a group home, but at that moment, for some reason, getting “messed up” was all the explanation I needed.
“How long have you been here?”
“Um…eight years,” she answered, looking in the other direction.
“Do you stay in touch with your son?”
We walked through the electric door into the supermarket.
“I talked to him on the phone…uh…about five years ago,” she said, distracted, “but they send me pictures and stuff,” and then, wanting to get on with her mission, she ended with a loud “Bye,” and headed down the aisle.
I watched her walk away, and thought of Bertha Mason.
She was Rochester’s crazy wife in Jane Eyre. They didn’t send her away, but locked her in the attic instead. That didn’t work out too well for Rochester. Bertha burned down the house and Rochester lost his arm and went blind in one eye. It was worse for Bertha. She jumped to her death from the burning rafters of Thornfield Hall.
Beryl, on the other hand, had been sent away, but now had a new family with middle-aged kids who needed her. She was looking sporty, and was on a mission. I nearly smiled.
A few of the residents had developmental disabilities, but a number of others had previously led lives that most people would call “normal.” There were veterans from two wars, for instance, and a former police officer. I was always curious about that. What had happened to them? What life-altering event had sent them into mental illness? Or maybe it didn't happen like that at all. I didn't know.
I had a chance to find out one day when I decided to walk to the grocery store.
The residents next door were constantly making trips to the store for cigarettes, beer or a cup of free coffee. Today, Beryl was marching out of the house next door as I headed down my front porch steps. She was dressed, as always, in a very sporty outfit, a definite New England look: cargo shorts, deck shoes, a horizontal-striped top, short cotton jacket and a lavender baseball cap. She turned in the direction of the store. I waited a few seconds, and fell in step beside her.
When Beryl was on a mission to the store, she would walk her deliberate walk and stare at the ground in front of her. Unless someone spoke to her, she would pass right by without ever looking up. It was different if she was trying to scrape up some change for a pack of cigarettes. She was like a heat-seeking missile at those times, but either way, I always spoke to her. Normally, I would get nothing more than an overly-loud “hello!” Sometimes she would add “how you doing?” Today, amazingly, Beryl was in the mood to talk.
It was her son’s birthday. He was twelve years old.
“Where is he?” I asked.
“He lives with his father,” she replied, “in Sao Paulo, Brazil.”
“Really?” I asked, and almost immediately regretted my word choice. I hadn’t even considered that she wasn’t telling the truth; I was just surprised.
“Yup,” she said unfazed, “I used to live in Brazil.”
"Wow." I was genuinely impressed. “How did you end up in Brazil?”
Of course, I really wanted to know how she ended up that house next door.
Beryl, focused on the sidewalk, twirled a strand of hair and told me how she’d met a young doctor, a brain surgeon, back in her home state of Vermont. She gave few details, but went on matter-of-factly, in a voice slightly too loud. Her young doctor was Brazilian. They married, and she moved to Sao Paulo where they had a son.
“But then I got messed up…and they sent me here.”
I had been extremely curious about Beryl, her housemates and how they had gone from relatively normal lives to a group home, but at that moment, for some reason, getting “messed up” was all the explanation I needed.
“How long have you been here?”
“Um…eight years,” she answered, looking in the other direction.
“Do you stay in touch with your son?”
We walked through the electric door into the supermarket.
“I talked to him on the phone…uh…about five years ago,” she said, distracted, “but they send me pictures and stuff,” and then, wanting to get on with her mission, she ended with a loud “Bye,” and headed down the aisle.
I watched her walk away, and thought of Bertha Mason.
She was Rochester’s crazy wife in Jane Eyre. They didn’t send her away, but locked her in the attic instead. That didn’t work out too well for Rochester. Bertha burned down the house and Rochester lost his arm and went blind in one eye. It was worse for Bertha. She jumped to her death from the burning rafters of Thornfield Hall.
Beryl, on the other hand, had been sent away, but now had a new family with middle-aged kids who needed her. She was looking sporty, and was on a mission. I nearly smiled.
2.04.2005
The Indelible Blossom of Crazy-House Flowers: Smokin' Beryl & The Sweet Black Angel
There are only two things in the world that I hate.
The first is puking. Boy, do I hate that.
The other is moving.
Given the choice, I would rather puke than move. It’s over faster, and the sounds I make when moving are even more horrifying than when projectile vomiting.
That’s why, when I moved to Nashville, it had to be over as quickly as possible. I didn’t shop around, check neighborhoods or anything. I just grabbed the newspaper, found an apartment I could afford on a street I could find, took my resume’, a copy of my credit report, some cash, and rented it on the spot.
It was small, drafty, and noisy; I stayed there for twelve years.
I really, really hate moving.
The apartment was the upper floor of a 1920’s bungalow-style house in east Nashville. The downstairs had been split into two apartments, in and out of which moved a never-ending procession of neighbors -- some of them I liked a lot; others not so much.
Next door, however, was a colossal Frankenstein of a house, a virtual labyrinth of additions (and subtractions), layered with siding, vinyl and otherwise, adorned with loads of plastic flowers and other ornamental lawn decor. I was fascinated.
I considered paying a visit with the traditional Welcome Wagon fare -- a six-pack of Pepsi and a 5-lb bag of flour -- but decided that it might look suspicious since I was the one moving into the neighborhood. It was best to just be patient. Surely someone would eventually need to hose off the plastic flowers. Until then, I could just peek through the mini-blinds.
One day, leaving for work, a woman approached from next door. She was 40-ish, gaunt; pallid, but looking very “New England” in what I think of as L.L. Bean clothes. She walked toward me with deliberate purpose.
I smiled.
She didn’t, but came straight toward me.
I said “Hey,” which is Southern for “Aloha.”
She said, in a voice too loud, “Got a cigarette?”
I did…and gave her one.
“My name’s Mike,” I offered.
She looked at me and said, “Got one for John?”
I blinked.
“He won’t come out of his room,” she said, as if that should explain everything.
“Oh,” I said, as if it had, and I handed her the pack of smokes.
“Take these. I’ve got more.”
She then smiled… a somber smile, thin-lipped and desolate…a tired smile, the hard smile of a hard life. She looked at the ground, then at my hand, and took the cigarettes.
“I’m Beryl.”
And with that, she turned and walked across the yard. She climbed the porch and knocked on the front door. “But…she just came out of there,” I thought to myself. In a moment, an unseen person opened the door and she disappeared inside.
That was my introduction to the people next door.
I asked my downstairs neighbor about them.
“That’s the crazy house,” she answered, and then in response to my puzzled look, “they are all mental patients.”
It was a group home for people from the mental health co-op. They weren’t totally crazy, my neighbor explained, and were able to come and go as they please during the day, but had to be in by a certain time at night.
“They’ll pester the shit out of you if you let them,” she’d added, “just shoo them away.”
Shoo them away…
I didn’t need to shoo them away.
The world had already done that.
There were indeed a dozen or more people living in the house, and whether Beryl had given me a thumbs-up, or, more likely, simply told them all that I had given her a pack of smokes, they instantly considered me a friend.
I’ve always felt a kinship with the outsiders, I suppose, and although I hadn’t previously known many mental patients, only some people who should have been but weren’t, I found myself drawn to the people in the house next door.
Mrs. Poole, a beautiful old African-American woman, would wheel herself out on the porch and spend the day watching the traffic go by. She didn’t seem particularly crazy to me, although every now and then she would wave to someone passing in a car as if she knew them. I never saw anyone wave to her though. I figured she was just being friendly.
My designated parking spot was close to the edge of the porch next door where Mrs. Poole would sit, and whenever she’d see me, she’d wave and speak, but always in a voice a little too low to understand. I’d walk over so I could hear her better, and she’d have me snared. I was constantly late because of her, but only because I didn’t want to leave once she started on one of her amazing tales.
I fell in love with Mrs. Poole. Her skin was beautiful, like glazed stoneware, an ancient and ageless statuette in her wheelchair there on the porch, tattered but still regal. She held court, and I became a loyal subject, basking in her wisdom and bowed with respect. She loved to talk, and at nearly 90, she had lots of stories to tell. The thing she didn’t have, and hadn’t had in a very long time, was someone to listen.
She’d spent most of her rough life in a segregated world, married at 14, and by the 1960’s, when White patrons stubbed out their cigarettes on the backs on African-Americans sitting at the soda counter in the Nashville Woolworth’s, she’d already had grandchildren. She had buried two husbands, and lost a son in the war. Her son was the only part of the story that she couldn’t tell with a smile.
Amazingly, in light of all this, in regard to everything else she had a wonderful sense of humor. She had been the first woman deacon in her church, but she had a devilish streak too, and would get a mischievous look in her eyes whenever she said something that a proper lady shouldn’t. She’d draw me into a long serious tale, and then dead-pan a sudden wisecrack that would make my mouth drop open. She’d laugh and laugh at my expression, and I would laugh that she’d reeled me in again. When she smiled, I thought I saw the plastic flowers lean toward her just a little.
During the winter months, I wouldn’t see her at all, but if I saw someone else from the house meandering down the street, I’d ask about Mrs. Poole, and ask them to say hello for me. When Mrs. Poole made her way back out onto the porch each year, I knew it was spring. After I’d known her a while, I would climb up on the porch and give her a hug the first time I’d see her.
“We made it through another winter, Michael,” she’d say.
“Yes ma’m, we sure did.”
“The Bradford Pears will bloom before long.”
“Yes m’am. I love those.”
“I do too, Michael.” Then a pause…“my niece is going to visit soon.”
“Oh, that’s nice,” I answered, “When will she be here?”
“Well…now that the weather’s nice, I’m sure she’ll come as soon as she can. She’s very busy, but I just have a feeling that this year she’ll come.”
Of course, she never did, but Mrs. Poole never stopped expecting her.
At first I found this terribly sad, but after a while, I realized that Mrs. Poole was never disappointed. She seemed oblivious to that fact that her niece never came. Eventually, I understood that this wasn’t about the visit at all.
It was about hope.
I suppose Mrs. Poole didn’t have a lot to hope for as she neared the end her long life, other than the peace of heaven, but it was her nature to be hopeful, to attribute good to those who didn’t warrant it, to expect the best from a world that had seldom, if ever, delivered. She didn’t have expectations, just hope. It was Mrs. Poole’s beatific delusion, and eventually I came to share her excitement over the invisible niece.
One day, as I left for work, she was on the porch in her church clothes. She would sometimes sit outside in her church clothes on Sunday, even if she didn’t have a way to get to church. She did it to pay her respects to the lord, she told me, but this day was not Sunday.
“Michael, I’m going to be moving,” she said.
I was shocked.
“You are?”
“Yes…my niece called and said she wants me to live with her. Isn’t that nice?”
I didn’t believe it for a moment.
“That’s great, Mrs. Poole. When will that be?”
“They are coming to get me today,” she answered.
I had known all along that a spring would eventually arrive when there would be no Mrs. Poole among the plastic flowers on the porch next door, and I had readied myself, as we do with the elderly, for the inevitable. I never expected to have the chance to say goodbye.
“I am sure going to miss you, Mrs. Poole,” I said, truthfully.
“Oh, you’ll still see me, Michael,” she said softly, “I’ll come back and visit sometimes when I’m out shopping with my niece.”
I reached up and took her scrawny black hand, which even on that sunny day held a chill.
I told her that I was lucky to have gotten to know her, and was honored to be her neighbor. She squeezed my hand and straightened up in her chair, as she would sometimes when proudly remembering her son. She started to say something, and her eyes got a little wet. She stopped, and put her other hand, long years crooked, on top of mine.
“You’re a good neighbor, Michael.”
She turned to me and smiled that smile – like being rocked in the arms of God -- and that was the last time I saw her.
I found out later that Mrs. Poole had been moved to another group home because she insisted on burning a candle in her room at night, which was against the rules. I thought about trying to visit, but didn’t want to embarrass her about the niece. A few months went by, and I decided to call her case-worker and find out how she was doing.
After several phone calls, I was able to find the case-worker assigned to Mrs. Poole. I explained that I was a former neighbor and was just wondering how she was doing.
“She’s gone,” the case worker said, all business.
“What?”
I prepared myself to hear the sad news.
“She’s gone from the group home," the case worker added, "She’s now living with her niece.”
Next: Mr. Teeter Dances with Mamie Eisenhower.
The first is puking. Boy, do I hate that.
The other is moving.
Given the choice, I would rather puke than move. It’s over faster, and the sounds I make when moving are even more horrifying than when projectile vomiting.
That’s why, when I moved to Nashville, it had to be over as quickly as possible. I didn’t shop around, check neighborhoods or anything. I just grabbed the newspaper, found an apartment I could afford on a street I could find, took my resume’, a copy of my credit report, some cash, and rented it on the spot.
It was small, drafty, and noisy; I stayed there for twelve years.
I really, really hate moving.
The apartment was the upper floor of a 1920’s bungalow-style house in east Nashville. The downstairs had been split into two apartments, in and out of which moved a never-ending procession of neighbors -- some of them I liked a lot; others not so much.
Next door, however, was a colossal Frankenstein of a house, a virtual labyrinth of additions (and subtractions), layered with siding, vinyl and otherwise, adorned with loads of plastic flowers and other ornamental lawn decor. I was fascinated.
I considered paying a visit with the traditional Welcome Wagon fare -- a six-pack of Pepsi and a 5-lb bag of flour -- but decided that it might look suspicious since I was the one moving into the neighborhood. It was best to just be patient. Surely someone would eventually need to hose off the plastic flowers. Until then, I could just peek through the mini-blinds.
One day, leaving for work, a woman approached from next door. She was 40-ish, gaunt; pallid, but looking very “New England” in what I think of as L.L. Bean clothes. She walked toward me with deliberate purpose.
I smiled.
She didn’t, but came straight toward me.
I said “Hey,” which is Southern for “Aloha.”
She said, in a voice too loud, “Got a cigarette?”
I did…and gave her one.
“My name’s Mike,” I offered.
She looked at me and said, “Got one for John?”
I blinked.
“He won’t come out of his room,” she said, as if that should explain everything.
“Oh,” I said, as if it had, and I handed her the pack of smokes.
“Take these. I’ve got more.”
She then smiled… a somber smile, thin-lipped and desolate…a tired smile, the hard smile of a hard life. She looked at the ground, then at my hand, and took the cigarettes.
“I’m Beryl.”
And with that, she turned and walked across the yard. She climbed the porch and knocked on the front door. “But…she just came out of there,” I thought to myself. In a moment, an unseen person opened the door and she disappeared inside.
That was my introduction to the people next door.
I asked my downstairs neighbor about them.
“That’s the crazy house,” she answered, and then in response to my puzzled look, “they are all mental patients.”
It was a group home for people from the mental health co-op. They weren’t totally crazy, my neighbor explained, and were able to come and go as they please during the day, but had to be in by a certain time at night.
“They’ll pester the shit out of you if you let them,” she’d added, “just shoo them away.”
Shoo them away…
I didn’t need to shoo them away.
The world had already done that.
There were indeed a dozen or more people living in the house, and whether Beryl had given me a thumbs-up, or, more likely, simply told them all that I had given her a pack of smokes, they instantly considered me a friend.
I’ve always felt a kinship with the outsiders, I suppose, and although I hadn’t previously known many mental patients, only some people who should have been but weren’t, I found myself drawn to the people in the house next door.
Mrs. Poole, a beautiful old African-American woman, would wheel herself out on the porch and spend the day watching the traffic go by. She didn’t seem particularly crazy to me, although every now and then she would wave to someone passing in a car as if she knew them. I never saw anyone wave to her though. I figured she was just being friendly.
My designated parking spot was close to the edge of the porch next door where Mrs. Poole would sit, and whenever she’d see me, she’d wave and speak, but always in a voice a little too low to understand. I’d walk over so I could hear her better, and she’d have me snared. I was constantly late because of her, but only because I didn’t want to leave once she started on one of her amazing tales.
I fell in love with Mrs. Poole. Her skin was beautiful, like glazed stoneware, an ancient and ageless statuette in her wheelchair there on the porch, tattered but still regal. She held court, and I became a loyal subject, basking in her wisdom and bowed with respect. She loved to talk, and at nearly 90, she had lots of stories to tell. The thing she didn’t have, and hadn’t had in a very long time, was someone to listen.
She’d spent most of her rough life in a segregated world, married at 14, and by the 1960’s, when White patrons stubbed out their cigarettes on the backs on African-Americans sitting at the soda counter in the Nashville Woolworth’s, she’d already had grandchildren. She had buried two husbands, and lost a son in the war. Her son was the only part of the story that she couldn’t tell with a smile.
Amazingly, in light of all this, in regard to everything else she had a wonderful sense of humor. She had been the first woman deacon in her church, but she had a devilish streak too, and would get a mischievous look in her eyes whenever she said something that a proper lady shouldn’t. She’d draw me into a long serious tale, and then dead-pan a sudden wisecrack that would make my mouth drop open. She’d laugh and laugh at my expression, and I would laugh that she’d reeled me in again. When she smiled, I thought I saw the plastic flowers lean toward her just a little.
During the winter months, I wouldn’t see her at all, but if I saw someone else from the house meandering down the street, I’d ask about Mrs. Poole, and ask them to say hello for me. When Mrs. Poole made her way back out onto the porch each year, I knew it was spring. After I’d known her a while, I would climb up on the porch and give her a hug the first time I’d see her.
“We made it through another winter, Michael,” she’d say.
“Yes ma’m, we sure did.”
“The Bradford Pears will bloom before long.”
“Yes m’am. I love those.”
“I do too, Michael.” Then a pause…“my niece is going to visit soon.”
“Oh, that’s nice,” I answered, “When will she be here?”
“Well…now that the weather’s nice, I’m sure she’ll come as soon as she can. She’s very busy, but I just have a feeling that this year she’ll come.”
Of course, she never did, but Mrs. Poole never stopped expecting her.
At first I found this terribly sad, but after a while, I realized that Mrs. Poole was never disappointed. She seemed oblivious to that fact that her niece never came. Eventually, I understood that this wasn’t about the visit at all.
It was about hope.
I suppose Mrs. Poole didn’t have a lot to hope for as she neared the end her long life, other than the peace of heaven, but it was her nature to be hopeful, to attribute good to those who didn’t warrant it, to expect the best from a world that had seldom, if ever, delivered. She didn’t have expectations, just hope. It was Mrs. Poole’s beatific delusion, and eventually I came to share her excitement over the invisible niece.
One day, as I left for work, she was on the porch in her church clothes. She would sometimes sit outside in her church clothes on Sunday, even if she didn’t have a way to get to church. She did it to pay her respects to the lord, she told me, but this day was not Sunday.
“Michael, I’m going to be moving,” she said.
I was shocked.
“You are?”
“Yes…my niece called and said she wants me to live with her. Isn’t that nice?”
I didn’t believe it for a moment.
“That’s great, Mrs. Poole. When will that be?”
“They are coming to get me today,” she answered.
I had known all along that a spring would eventually arrive when there would be no Mrs. Poole among the plastic flowers on the porch next door, and I had readied myself, as we do with the elderly, for the inevitable. I never expected to have the chance to say goodbye.
“I am sure going to miss you, Mrs. Poole,” I said, truthfully.
“Oh, you’ll still see me, Michael,” she said softly, “I’ll come back and visit sometimes when I’m out shopping with my niece.”
I reached up and took her scrawny black hand, which even on that sunny day held a chill.
I told her that I was lucky to have gotten to know her, and was honored to be her neighbor. She squeezed my hand and straightened up in her chair, as she would sometimes when proudly remembering her son. She started to say something, and her eyes got a little wet. She stopped, and put her other hand, long years crooked, on top of mine.
“You’re a good neighbor, Michael.”
She turned to me and smiled that smile – like being rocked in the arms of God -- and that was the last time I saw her.
I found out later that Mrs. Poole had been moved to another group home because she insisted on burning a candle in her room at night, which was against the rules. I thought about trying to visit, but didn’t want to embarrass her about the niece. A few months went by, and I decided to call her case-worker and find out how she was doing.
After several phone calls, I was able to find the case-worker assigned to Mrs. Poole. I explained that I was a former neighbor and was just wondering how she was doing.
“She’s gone,” the case worker said, all business.
“What?”
I prepared myself to hear the sad news.
“She’s gone from the group home," the case worker added, "She’s now living with her niece.”
Next: Mr. Teeter Dances with Mamie Eisenhower.
1.05.2005
Documents Prove The FDA No Longer Protects Us.
It is a sad day when some guy sitting at his home computer can find evidence that the FDA is no longer serving the public interest, while the major news organizations don’t seem to care.
I suppose it shouldn’t be surprising, considering that the EPA has become a tool of polluters rather than an agency protecting the health & welfare of U.S. citizens, but most of us have a difficult time accepting that the Food & Drug Administration has gone from serving the public interest to serving the interests of pharmaceutical buck-junkies.
A recent story caught my eye about an FDA warning letter sent to Novartis Animal Health U.S. Inc. Novartis tested an animal painkiller called Deremaxx, which is in the same chemical family as Celebrex and Vioxx, both linked to heart attacks in humans, and the Novartis experiment resulted in an inordinate number of dead cats.
The FDA requires that results of experiments like these be reported, but Novartis didn’t bother. The experiment took place in July of 2003, but only after a February 2004 FDA inspection of the drug maker’s facilities did Novartis submit the required reports.
The FDA also requires that drug companies submit a study plan prior to conducting experiments, but Novartis didn’t submit a plan at all – until three months after the study was concluded.
The FDA issued a letter of warning.
Odd, I thought, that such blatant disregard for FDA regulations would result in nothing more than a letter of warning, so I decided to look into it a little further.
What I found, to be frank, was a bit terrifying.
A quick Google search turned up three current newswire stories about FDA warning letters issued to drug companies. Besides the Novartis letter, one was sent to Chiron Corporation, the flu vaccine manufacturer whose U.K. plant was shut down due to contamination, which in turn caused a shortage of vaccine for this year’s flu season.
In early October, regulators in the U.K. shut down the plant because of wide-spread sanitation problems. Later that month, after outrage in the U.S., the FDA inspected the facility as well. The FDA issued a letter of warning, but not until December.
The letter contained hardly any “warning” at all. The FDA simply asked for more information on Chiron’s plans to address the problem. In the meantime, U.K. regulators decided that the problem were not being addressed at the Chiron plant, and extended the closure until April, 2005. Apparently, had the U.K. regulators not stepped in, the plant would still be in operation.
Yesterday, news broke that the FDA letter-writers had been at it again. This time, they sent a warning letter to a Houston-based company called Cyberonics, which makes implantable devices to treat epilepsy. The FDA informed Cyberonics that the manufacturing plant did not meet U.S. requirements.
The FDA inspected the Cyberonics plant for two months, from July to September, and raised the issues with the company at the end of the inspections. Cyberonics responded to the FDA inquiry, but the FDA found the company’s response to be incomplete and evasive. Finally, last month, the FDA sent another letter of warning to warn that the previous three letters of warning sent in 2004 had not been addressed.
The FDA’s December letter to Cyberonics is shocking…and a little sickening.
After the 2004 inspection, the FDA asked Cyberonics to explain “a number of significant QS regulation violations.” Not only did Cyberonics refuse to adequately address the issues, but it basically told the FDA that they were the ones who approved the design of the device, so Cyberonics shouldn’t be held accountable.
The FDA’s letter is a laundry list of despicable practices by Cyberonics. Among those:
* The failure of Cyberonics to investigate and evaluate the cause of each “medical adverse event” caused by its device, as required by law.
* The failure to provide any documentation of the deliberations that led the company to claim that it could find no reason why its implanted device would migrate through the patient’s body unexpectedly, leading to an increase in the severity of seizures, and many deaths.
* A failure to establish procedures for validating the design of the device.
* A failure to test the device design in actual or simulated conditions, which is required by law.
* A failure to explain Cyberonics’ assertion that no “real-time” testing was needed to determine the longevity of the implant, which is placed in a patient’s chest, or any evidence to back up the theories it used to determine the device’s life-span.
* A failure to determine even the most fundamental qualities of the device, such as the impact of more frequent usage in some patients on the device’s battery life.
* A failure to investigate patient’s complaints that the device longevity was too short. Cyberonics refused to consider these “product complaints” and didn’t bother to collect any information from the patient or the patient’s device to determine if the device had any problems.
* A failure to document death data in patients that used the device, or compile the data according the age category as required.
* Failure to investigate the complaints from doctors who said the device didn’t deliver the proper amount of electrical current during the last 6-12 months of the device lifespan.
* A failure to investigate its work operations, processes or other areas that might result in “non-conforming product.”
* A failure to provide information that Cyberonics had collected regarding adverse events related to its product.
* The finding that Cyberonics used bogus explanations for over 1000 patient complaints, coding them as situations that simply required removing the device and implanting another.
* The failure to collect any information on patients using its device over the past five years that might prove or disprove the company’s theories about long-term usage.
* The failure of Cyberonics to implement any changes that were needed to prevent or correct identified problems.
* A failure to document, investigate or analyze the reasons for “thousands of reimplants since 1997.”
The list goes on, and even the FDA admits that its letter is not a definitive list of all the problems at Cyberonics, but it gets worse.
The FDA noted that Cyberonics didn’t follow its own policy on notifying doctors when there had been a “user error.” The company did not send letters to 197 doctors who reported serious injuries in patients, or to 99 doctors who reported device malfunctions, or to 53 doctors who reported that the device caused a patient’s death – but Cyberonics coded all of these complaints as “user error.”
It gets even worse still. Many of the patients using the device were under the age of 12, yet use in children has not been approved by the FDA. That makes it an “off label” use, so all of the complaints that involved children were automatically coded as “user error” and no further investigations were conducted.
Even in these cases, Cyberonics did not send letters to the doctors prescribing the device that could have helped explain how to avoid those deadly user errors in the future.
In light of all these violations of law and regulation, and after having sent warning letters to Cyberonics in years past, the FDA still did nothing but issue another letter of warning.
How can this happen?
It’s simple.
You may have heard before about “off label” uses for pharmaceutical products. A few years back, it became a huge debate in congress. The GOP was adamant that pharmaceutical companies had the right to promote uses of their products that had not yet been approve by the FDA, the so-called “off label” uses, which makes perfect sense if you think whoring for a dollar is more important that the safety of our citizens.
The Clinton FDA prohibited drug companies from promoting unapproved usages of their products, but the GOP led the fight to have that rule overturned. Under the guise of giving doctors “freedom,” the Republicans weakened the power of the FDA to oversee and regulate pharmaceutical companies. Ironically, they prohibit doctors in other countries that receive financial aid from the U.S. from discussing valid, approved reproductive choices with their female patients.
In this paper from the U.S. Senate Republican Policy Committee, they brag that they had successfully “clipped the FDA's wings.”
This, of course, is all in the name of the free market. We certainly want those struggling pharmaceutical companies to be able peddle any faulty device or medication they can concoct, even when it results in the deaths of children.
Now, the FDA is nothing more than a sham.
In all, the FDA sent 36 warning letters in 2004. Some of those companies, like Cyberonics, have received multiple warnings in the past, yet nothing is done. If not for legitimate U.K. regulators, we would have surely been injecting people with contaminated flu vaccine this year.
If you are ready to get pissed off, check the letters out for yourself. Notice how many companies are being "warned" that the promotional materials they provide to doctors are misleading, or fail to properly warn of dangerous side-effects. Also notice how many of those companies have been warned again and again, and then notice how lame the "warnings" contained in the letters actually are.
At what point will the FDA stop warning companies like Cyberonics, and do something to protect us? The FDA now serves the industry it was designed to regulate, just as our nation's leaders serve any industry with the bucks to buy their influence.
I suppose it shouldn’t be surprising, considering that the EPA has become a tool of polluters rather than an agency protecting the health & welfare of U.S. citizens, but most of us have a difficult time accepting that the Food & Drug Administration has gone from serving the public interest to serving the interests of pharmaceutical buck-junkies.
A recent story caught my eye about an FDA warning letter sent to Novartis Animal Health U.S. Inc. Novartis tested an animal painkiller called Deremaxx, which is in the same chemical family as Celebrex and Vioxx, both linked to heart attacks in humans, and the Novartis experiment resulted in an inordinate number of dead cats.
The FDA requires that results of experiments like these be reported, but Novartis didn’t bother. The experiment took place in July of 2003, but only after a February 2004 FDA inspection of the drug maker’s facilities did Novartis submit the required reports.
The FDA also requires that drug companies submit a study plan prior to conducting experiments, but Novartis didn’t submit a plan at all – until three months after the study was concluded.
The FDA issued a letter of warning.
Odd, I thought, that such blatant disregard for FDA regulations would result in nothing more than a letter of warning, so I decided to look into it a little further.
What I found, to be frank, was a bit terrifying.
A quick Google search turned up three current newswire stories about FDA warning letters issued to drug companies. Besides the Novartis letter, one was sent to Chiron Corporation, the flu vaccine manufacturer whose U.K. plant was shut down due to contamination, which in turn caused a shortage of vaccine for this year’s flu season.
In early October, regulators in the U.K. shut down the plant because of wide-spread sanitation problems. Later that month, after outrage in the U.S., the FDA inspected the facility as well. The FDA issued a letter of warning, but not until December.
The letter contained hardly any “warning” at all. The FDA simply asked for more information on Chiron’s plans to address the problem. In the meantime, U.K. regulators decided that the problem were not being addressed at the Chiron plant, and extended the closure until April, 2005. Apparently, had the U.K. regulators not stepped in, the plant would still be in operation.
Yesterday, news broke that the FDA letter-writers had been at it again. This time, they sent a warning letter to a Houston-based company called Cyberonics, which makes implantable devices to treat epilepsy. The FDA informed Cyberonics that the manufacturing plant did not meet U.S. requirements.
The FDA inspected the Cyberonics plant for two months, from July to September, and raised the issues with the company at the end of the inspections. Cyberonics responded to the FDA inquiry, but the FDA found the company’s response to be incomplete and evasive. Finally, last month, the FDA sent another letter of warning to warn that the previous three letters of warning sent in 2004 had not been addressed.
The FDA’s December letter to Cyberonics is shocking…and a little sickening.
After the 2004 inspection, the FDA asked Cyberonics to explain “a number of significant QS regulation violations.” Not only did Cyberonics refuse to adequately address the issues, but it basically told the FDA that they were the ones who approved the design of the device, so Cyberonics shouldn’t be held accountable.
The FDA’s letter is a laundry list of despicable practices by Cyberonics. Among those:
* The failure of Cyberonics to investigate and evaluate the cause of each “medical adverse event” caused by its device, as required by law.
* The failure to provide any documentation of the deliberations that led the company to claim that it could find no reason why its implanted device would migrate through the patient’s body unexpectedly, leading to an increase in the severity of seizures, and many deaths.
* A failure to establish procedures for validating the design of the device.
* A failure to test the device design in actual or simulated conditions, which is required by law.
* A failure to explain Cyberonics’ assertion that no “real-time” testing was needed to determine the longevity of the implant, which is placed in a patient’s chest, or any evidence to back up the theories it used to determine the device’s life-span.
* A failure to determine even the most fundamental qualities of the device, such as the impact of more frequent usage in some patients on the device’s battery life.
* A failure to investigate patient’s complaints that the device longevity was too short. Cyberonics refused to consider these “product complaints” and didn’t bother to collect any information from the patient or the patient’s device to determine if the device had any problems.
* A failure to document death data in patients that used the device, or compile the data according the age category as required.
* Failure to investigate the complaints from doctors who said the device didn’t deliver the proper amount of electrical current during the last 6-12 months of the device lifespan.
* A failure to investigate its work operations, processes or other areas that might result in “non-conforming product.”
* A failure to provide information that Cyberonics had collected regarding adverse events related to its product.
* The finding that Cyberonics used bogus explanations for over 1000 patient complaints, coding them as situations that simply required removing the device and implanting another.
* The failure to collect any information on patients using its device over the past five years that might prove or disprove the company’s theories about long-term usage.
* The failure of Cyberonics to implement any changes that were needed to prevent or correct identified problems.
* A failure to document, investigate or analyze the reasons for “thousands of reimplants since 1997.”
The list goes on, and even the FDA admits that its letter is not a definitive list of all the problems at Cyberonics, but it gets worse.
The FDA noted that Cyberonics didn’t follow its own policy on notifying doctors when there had been a “user error.” The company did not send letters to 197 doctors who reported serious injuries in patients, or to 99 doctors who reported device malfunctions, or to 53 doctors who reported that the device caused a patient’s death – but Cyberonics coded all of these complaints as “user error.”
It gets even worse still. Many of the patients using the device were under the age of 12, yet use in children has not been approved by the FDA. That makes it an “off label” use, so all of the complaints that involved children were automatically coded as “user error” and no further investigations were conducted.
Even in these cases, Cyberonics did not send letters to the doctors prescribing the device that could have helped explain how to avoid those deadly user errors in the future.
In light of all these violations of law and regulation, and after having sent warning letters to Cyberonics in years past, the FDA still did nothing but issue another letter of warning.
How can this happen?
It’s simple.
You may have heard before about “off label” uses for pharmaceutical products. A few years back, it became a huge debate in congress. The GOP was adamant that pharmaceutical companies had the right to promote uses of their products that had not yet been approve by the FDA, the so-called “off label” uses, which makes perfect sense if you think whoring for a dollar is more important that the safety of our citizens.
The Clinton FDA prohibited drug companies from promoting unapproved usages of their products, but the GOP led the fight to have that rule overturned. Under the guise of giving doctors “freedom,” the Republicans weakened the power of the FDA to oversee and regulate pharmaceutical companies. Ironically, they prohibit doctors in other countries that receive financial aid from the U.S. from discussing valid, approved reproductive choices with their female patients.
In this paper from the U.S. Senate Republican Policy Committee, they brag that they had successfully “clipped the FDA's wings.”
This, of course, is all in the name of the free market. We certainly want those struggling pharmaceutical companies to be able peddle any faulty device or medication they can concoct, even when it results in the deaths of children.
Now, the FDA is nothing more than a sham.
In all, the FDA sent 36 warning letters in 2004. Some of those companies, like Cyberonics, have received multiple warnings in the past, yet nothing is done. If not for legitimate U.K. regulators, we would have surely been injecting people with contaminated flu vaccine this year.
If you are ready to get pissed off, check the letters out for yourself. Notice how many companies are being "warned" that the promotional materials they provide to doctors are misleading, or fail to properly warn of dangerous side-effects. Also notice how many of those companies have been warned again and again, and then notice how lame the "warnings" contained in the letters actually are.
At what point will the FDA stop warning companies like Cyberonics, and do something to protect us? The FDA now serves the industry it was designed to regulate, just as our nation's leaders serve any industry with the bucks to buy their influence.
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