http://www.youtube.com/watch?v=djJ3OHBU6hc

http://www.floxedbylevaquin.com/p/care-book.html

http://www.pharmalot.com/2012/04/jj-is-fined-1-billion-over-risperdal-marketing/

This is a very sad story. I talked to Mike and Connie many years ago but did not stay in touch with them for a while. They were both very nice people. I received this message from Connie below. The spacing is a little broken up. Such a tragic story of Fluoroquinolone poisoning.  

My husband first took Cipro in 1998. He was a former Marine and in great shape. He was intelligent and so strong physically. He kept in shape by working all the time. He got sick and went to our family doctor asking the doctor to get him well quicker so he wouldn’t miss any work. He was prescribed Cipro and he took it all. I had no idea that all the things that started happening to him then were adverse reactions after taking this medicine. The one thing we lacked knowledge on was anything to do with medical. Shortly after taking Cipro, things began to happen to his body. He started having a lot of pain in his muscles and joints almost like RA. He thought it was because he had overworked his body to the point it was rebelling on him. He was in his early 40′s at that time. His arms and legs started to jerk and it was worse when he tried to rest. It’s the kind like you may observe a dog sleeping and while asleep their legs move like they’re trying to run. My husband’s was worse than that though. Small blisters with fluid appeared around his ankles.

He thought maybe he got bitten by fireants but couldn’t quite remember when or how that happened. We didn’t know it was a type of rash. We’d never seen a rash like that before. Several times he’d wake up with the left corner of his bottom lip so swollen that it looked deformed. He thought maybe something had bitten him on his lip while he slept. We didn’t know this was angioedema of the lip. Never saw anything like it before. He started having some difficulty with his memory which was unusual for he was intelligent and
aced things easily. For the first time in his life he was struggling with learning things.

He started having anxiety and panic attacks. The panic attacks were the worst. He also had problems sleeping. Usually he slept quite well, but now had insomnia. He thought it was because of the pain in his body keeping him up. He would have vivid nightmares when he would sleep. I remember waking up 1 night listening to him talking in his sleep in a foreign language. I thought it might have been french but whatever it was he seemed to speak it fluently. I woke him up to ask him what he was talking about. He didn’t believe me nor did he think he was speaking in another language. He didn’t remember anything. 

He started having problems at work. He was the type that whatever he worked on had to be perfect. It was very rare for him to make a mistake. He started making mistakes at work where he was an electrician at International Paper Company. He would get so angry at himself when this happened. He started getting really depressed. Also he was changing in other ways. Agitation, aggravation, anger, short tempered, some bouts of rage where appearing. I thought it was because of the physical pain he was feeling in his body and lack of sleep. It got to where I felt like I was walking on needles and pins nearly everyday afraid anything I said or did would set him off. It
didn’t take much. He was changing mentally but I didn’t know why.

There’s a line morally that I like to think most people have and you don’t cross that line. His moved completely out of sight. He did things that were irrational like driving over 100mph and passing people on the shoulder of the road where you usually pull over with car problems. I was afraid to say anything thinking it would make him fly into a rage. I did a lot of silent praying that we wouldn’t get into an accident and be killed. It was pretty scary. That just wasn’t normal for him.

Around 9 months after taking Cipro, he put a .38 in his mouth and tried to blow his brains out. The gun jerked when he fired it and the bullet went through his cheek. Probably cause his arms and legs would jerk on their own accord. I thank God for watching over him cause that wasn’t the first attempt, He had never in his life tried to commit suicide before until after taking Cipro. The first rupture happened around 11 months after taking Cipro. It was in the soleus group I think. It tore completely loose in the back of his left leg at the ankle and bunched up near the back of his knee. It looked like someone who had polio. He stopped wearing shorts then cause he was ashamed of the deformed way his left leg looked. He couldn’t run anymore after that. He couldn’t walk fast either. It left him with a permanent limp. He has started having problems with bleeding in his feces not long after taking Cipro. He was having numbness in his feet but thought it was working too hard and being cramped up in places he worked on his job.

There were a few occurrences where he was not himself at all. I didn’t know what a psychotic episode was. Never saw one so I didn’t know what was going on when he went into this bad rage and attacked me. Our daughter who was a police officer was there and it hurt her so badly taking her father down after he lunged at me with a screwdriver. I can still remember her saying “no daddy” as she restrained him. There was so much pain in her voice.  She thought he had stabbed me in the stomach. I remember just standing there in shock as he came at me and something making me bend over as if I had been struck in the stomach. I think the Lord was still watching over us cause I was unharmed. My husband had never physically abused me ever nor even tried until after he took Cipro. It was like some stranger had taken over his body and he was trapped inside helpless.  Many years later I finally asked him about that incident. He had no memory of himself ever doing that and it hurt him so badly to find out he tried to harm me.

There was another rupture in his right knee months later. It was operated on to repair it, but months later another rupture happened in the right leg but this time it was a muscle that tore apart in the center of his thigh. Now both of his legs were damaged with tears present in both. I bought every kind of brace and sport supports to help him to be able to walk. I wrapped his legs in ace bandages on top of those. Kind of like a mummy. He was taking a lot of pain pills while trying to work. He said as long as he had 2 good arms left, he was going to make a living for his family. It might sound silly, but he had names for his arms. 1 was thunder and the other lightening. He was proud of the strength in his arms and hands. I know how strong he was. He picked up a truck transmission and put it in place by himself. That’s strong. He tried to get a desk job where he worked cause his legs were so weak. Sometimes he’d fall at work when they gave out and he’d tell people who saw it he slipped on something. He didn’t want to lose his job. He was making
around $60,000 a year. It was a good paying job. Most people take vacation and go somewhere or relax. He would take his when his legs couldn’t carry him anymore and try to recuperate so he could get back to work. Once he took a tool you burn things with like a soldering iron while at work and during a depression spell he burned deep into his left forearm I think the word “crazy”. The burns
were really bad.

Later on he burned his arm again even deeper erasing the words. This left a deep scar about 1/2″ wide and 2 1/2 to 3″ long. I can’t imagine the pain he suffered doing that to himself. A desk job had become available and a group from the shop he worked in were standing around discussing it. They were saying they didn’t want it. My husband spoke up and said he’d like to take it. Someone behind him said something along the lines “great, a crazy guy in charge”. He didn’t get the job though he really wanted it so he didn’t have to use his legs as much. I know it hurt him to hear people say aloud things like that about him. He must have endured so much.

For a few years, the depression seemed to ease up some and there were no suicide attempts during that time. His legs weren’t any better, some of the mental things like rage eased up and I didn’t feel like I was walking on pins and needles everyday. The arms and legs were still jerking, he still had anxiety and panic attacks, the bleeding, and the pain in his muscles and joints were still there.
He was prescribed CiproXr in 2004. I thought the worst was over up till then, but everything got worse after that. The suicide attempts started again. He was becoming paranoid. He did things that were definitely out of character for him. The anger and agitation came back. I was back to walking on pins and needles again. The bleeding became so bad that he would call me at home to bring him a change of clothing. I won’t tell all the things he tried to keep from bleeding through his clothes every time he went to
the bathroom. His lip showed up swollen again just like the first time. This time I knew he had a rash but not sure what was causing it. He thought maybe he got into some chemicals at work. They were big sores with dark centers in patches on his body. He was having pain around the kidney area. Had no clue what that was. The jerking of his arms and legs got a whole lot worse. There were times when I thought he had fallen asleep and his arms and legs were flopping. Sometimes at night they flopped like a fish on a bank trying to get back into the water. Sometimes it looked like only the legs and arms were being electrocuted. Years later I began to wonder if they were seizures. I told the doctor my husband was having restless leg and arm syndrome. He put him on a medicine to try to help control that. It only helped a little but was better than it was.

He started having migraines. Sometimes they had what the doctor called an aura. My husband couldn’t see right when this happened. They were very painful. I forgot to mention the numerous times he got shingles. That was painful too for him. He was starting to have more numbness in his hands. He was always dropping things. It became harder for him to use his tools like screwdrivers. His legs were getting more numb and weaker.

Around 11 months after taking CiproXR, he rupturing began again. This time in his arms. First it was the right arm. The doctor operated and told me my husband had lack of blood in his tissue. After the operation, my husband’s arms didn’t match in size. The one operated on looked a whole lot smaller. The doctor said he cut away dead tissue. It looked like someone had switched arms with him, someone who had no muscle and thin arms. This started in Feb 2005 and was the last time my husband could work. Months later he felt something tear in his arm. There was now damage to the triceps and biceps in his right arm.  He had 1 good arm left that hadn’t ruptured. He was trying to be useful and was squeezing a clamp with the same amount of pressure you would use to squeeze a blood pressure bulb. Something popped in his lower left forearm and it bruised up. He had torn a tendon in his lower left forearm. Now both arms are damaged and both legs. His sick pay was ending where he worked so he applied for long term disability. He was denied. He also applied for SSD and was denied. I never could understand why he was denied. He had all these injuries and the doctors had no idea what was causing it. We were running out of money and things were getting tough. This didn’t help his depression at all. I still have a suicide note he had left for me when he made 1 of his attempts. He was denied a second time for SSD. It was appealed and we went through it again. By this time my husband has all his pride stripped away. The system made him feel like he was nothing and insignificant. Sedgwick CMS was doing the disability for International Paper Company. Sedgwick denied the appeal for disability from International Paper. My husband was finally approved SSD. He was terminated from International Paper cause he couldn’t go back to work. We thought we had a lawyer to fight for his disability from International Paper. That lawyer told us to be patient and that it was going to take years. So we waited and waited.

Last year we called him checking on the status of how things were going. He told us he had dropped it long ago but we never knew that. After that we tried to get another lawyer but they all said we had run out of time. My husband’s health is continually declining. He has to use a wheelchair now and rarely leaves the house. He had test done at the VA that showed he had nerve damage. He had gotten to the point long before that where he would have to ask me to open things for him like a pack of lunchmeat cause his hands were weak and numb. His immune system was getting worse. He was falling more often in the house when he would go from his recliner to the bathroom. He lived his life in that recliner. His body had become so weak and his breathing was terrible. He slept in his recliner cause he couldn’t breathe well laying down. Even though he suffered so much pain, everyday he would greet me with a smile and tell me he loved me. That’s all I needed. 

None of this was his fault. All he did was take a medicine to make him feel better. Feb. 23, 2012, I tried to wake him up, but he wouldn’t wake up. I called my son-in-law over to try to wake him. There were people in my house but I don’t remember seeing them. I remember telling them he’s always cold, that he’s just asleep and won’t wake up. I remember very little of what happened for the next few days. He was only 55 years old. Before taking this medicine he was a strong and intelligent man. How could this happen or be allowed to happen. I didn’t even have the money to bury him. I’m thankful our 2 daughters stepped in and took up payments for his
burial. He was my life. Everyday is empty without him. Half of me is ripped away. He didn’t deserve that to happen to him. He was a good man. His name was Michael. He didn’t do anything wrong, but he is the one who suffered so many years through so much physical and mental pain. He was done so wrong in this life. His obituary can be veiwed at http://www.goldenfh.com/fh/obituaries/obituary.cfm?id=1405286&fh_id=10162

http://www.wired.com/wiredscience/2012/02/factory-farm-shrimp/

I received a phone call a few weeks ago from a very determined Levaquin advocate. She was very upset. She told me that Dr. Karen Weiss has left the FDA to go work for Johnson & Johnson, the company that markets Levaquin. The Levaquin advocate said she was informed of this from a doctor who has a sister that is employed by Johnson & Johnson. Dr. Weiss is the Program Director for the US Food and Drug Administration’s Safe Use Initiative in the Center for Drug Evaluation and Research. The program’s mission is to reduce preventable harm from medications, which is a significant public health problem. 

I called the Food & Drug Administration to verify the employment status of Dr. Weiss. I was told that Dr. Karen Weiss is not in the FDA global employment directory. I later contacted Johnson & Johnson and was informed that there is in fact a Dr. Karen Weiss employed at J&J.   

I had a one hour meeting with Dr. Karen Weiss and a few other doctors regarding fluoroquinolone toxicity on July 13th, 2010. Dr. Weiss was given many medical articles on the severe and long term injuries from this class of antibiotics. Other fluoroquinolone victims have provided her with extensive documentation on this issue as well. Dr. Weiss was given information on reducing preventable harm from Levaquin and fluoroquinolones in general. I feel that Dr. Weiss chose to look the other way on this important health problem.

FDA officials are frequently rewarded with lucrative jobs at the very companies they are supposed to regulate. They just need to keep industry happy. This is an insidious conflict of interest. I called the Food and Drug Administration last week inquiring if this was an FDA ethics policy violation. I was told that there is a certain amount of time that bars a Food and Drug Administration employee from moving to industry and vice versa. The FDA employee wasn’t sure about the exact number of years one has to remove themselves from employment. The Food and Drug Administration needs to properly enforce this revolving door problem. The quality of regulation and oversight is severely compromised resulting in further promotion of unsafe drugs.  

Blood Feud by Kathleen Sharp

A True Story About Procrit, Amgen and Johnson & Johnson

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Kathleen Sharp

KATHLEEN SHARP is an acclaimed author and award-winning investigative journalist. She is the author of true-life thriller, Blood Feud, The Man Who Blew the Whistle On One of the Deadliest Prescription Drugs Ever, in addition to four acclaimed non-fiction books.

Sharp has written for The New York Times Magazine, Parade, Elle, Playboy, and Fortune, among many others. She’s produced segments for National Public Radio’s Morning Edition and appeared and consulted on film documentaries for Turner Classic Movies, the Biography Channel, and Bravo. Sharp has also contributed to several anthologies, including one that was nominated for an Edgar award. Her many awards include a first place prize for investigative reporting from the Society of Professional Journalists; an economic fellowship to study at the Graduate School of Business at the University of Washington; and a health-care fellowship from the University of Southern California’s Annenberg School for Communication. An avid runner, Sharp lives in Santa Barbara with her family.

View An Interview with Kathleen Sharp

 

Behind the Scenes of the Real-Life Thriller, Blood Feud

Tell us what BLOOD FEUD is about.

BLOOD FEUD is the true story of Mark Duxbury and Dean McClellan, two legendary sales reps for Johnson & Johnson who race against Big Pharma to blow the whistle on one of the riskiest, deadliest medicines ever, called epo. It’s also a behind-the-scene look at Johnson & Johnson and Amgen, the drug “partners” who wind up fighting over the $100 billion blockbuster.

What is Procrit?

Procrit is a top brand name for epo. It’s an anti-anemia drug that helps the body make red-blood cells, allowing patients to avoid blood transfusions. For decades, doctors have prescribed this medication to people suffering from AIDS, kidney disease, cancer and simple fatigue. About 20 million people have been injected with the drug.

By 1996, however, studies showed that Procrit and the other brands could cause heart attacks, tumor growth and even death. Just two months ago, in June 2011, I was shocked when the FDA announced that most patients should avoid the drugs entirely.

Yet, Procrit and the others are still on the market. And Medicare still pays for these expensive brands. Here’s a great example of how out healthcare dollars are wasted on risky blockbusters.

How did you find this story?

Whistleblower Mark Duxbury contacted me in 2004 after reading some of my work. He sent me his lawsuit, along with some documents, and urged me to write an article about Procrit’s overuse. But I was skeptical. His story seemed too outrageous to be true, so I put it aside for years. Yet, Duxbury kept calling. Charming and smart, he persuaded me that this was a huge story.

In 2007, Congress and the FDA began holding hearings on the deceptive sales practices and health risks behind these drugs. I scraped up some money and hopped on a red-eye flight to Washington DC. The next morning, I walked into a packed meeting and witnessed the significance of Duxbury’s tale.

Regulators had just slapped a “black-box” warning on the drug. Patients wanted it pulled from the shelves, but executives at Amgen and Johnson & Johnson were allowed to keep selling their dangerous products. That’s when I finally “got” it:  Here was an opportunity to describe the inner workings of a powerful global pharmaceutical industry as seen through the eyes of two of its star sales reps.

What kind of research did you do for writing this book?

I spent four years flying around the country and interviewing about 100 sources. I used documents from congressional hearings, regulatory meetings, and court proceedings along with reams of published news stories, company sales materials and the personal records of my main sources.

Why hasn’t anyone written about it before?

The New York Times has reported on bits and pieces of the epo story, while The Wall Street Journal featured Duxbury’s whistle blowing case as it wended its way through the U.S. District Court in Boston. Yet no one had laid out the entire story, partly because it’s so complicated. Here’s a 25-year-long saga that unfolds mostly behind the curtain, with such a scope as to be almost overwhelming. I spent four years flying around the country and interviewing about 100 sources. I used documents from congressional hearings, regulatory meetings, and court proceedings along with reams of published news stories, company sales materials and scientific studies. I wove boxes of this material through the personal accounts of my four main sources.

What does Johnson & Johnson say?

I contacted J&J representatives and lawyers about a dozen times over the year, asking for on-the-record interviews. But they consistently declined my requests. That stumped me: Here was a company that had set the gold standard for corporate accountability. After six people died during the 1982 Tylenol scandal, J&J recalled millions of bottles of Tylenol pills and launched a huge PR campaign to inform the public. Yet, in the wake of the much-larger Procrit crisis, when 100 times more patients have been harmed, J&J was stonewalling. That made me even more passionate about writing this story.

Tell us about former salesmen, Mark Duxbury and Dean McClellan, and their attorney Jan Schlichtmann, who signed agreements to work exclusively with you.

Duxbury was a star salesman at a J&J unit, selling the biotech drug throughout the Pacific Northwest. He had a strong sense of right and wrong, which is why he ultimately blew the whistle on J&J.

Duxbury’s best friend was Dean McClellan, who worked in the Southwest and became a Procrit sales legend. McClellan believed in the American Dream and in J&J, despite his friend’s warnings. McClellan refused to consider that J&J, whose famous credo pledged to put people first, would actually promote a drug illegally. But after news stories confirmed that he and J&J’s sales force had harmed patients by selling Procrit off-label, McClellan had to admit that his friend had been right all along. “We’ve been killing people,” he realized in horror. That’s when McClellan began secretly feeding Duxbury sales documents to use in his whistle blowing suit.

Jan Schlichtmann, as everyone knows, is the crusading attorney made famous by the bestselling book and Oscar-nominated movie A Civil Action. When Duxbury asked him to take on his suit, the lawyer eagerly agreed. But Schlichtmann found himself outflanked by J&J’s high-powered legal team and stymied by a Department of Justice that was managed, it turned out, by former members of J&J’s defense team.

This case has had more twists and turns than a thriller. Can you explain?

For a while, Duxbury’s case seemed lost. But in 2009, he and Schlichtmann won on appeal and prepared for trial. But then Duxbury died one night in his sleep.  Schlichtmann was devastated and I broke down and cried.  It was heartbreaking to have followed Duxbury to victory’s door only to have him pass away.

Schlichtmann eventually regained his foothold. Still, as Duxbury’s case moves forward, Schlichtmann wonders if he’s mired in another long-running travesty of justice—A Civil Action II.

Who is Sharon Lenox?

Sharon is the widow of a man who bled to death after receiving too much Procrit. She later learned that her husband had received high doses of epo despite repeated federal warnings. At an FDA meeting, she expressed her outrage about the lack of patient consent. Later, the FDA decided that all patients must sign a consent form before being injected with epo. To me, Sharon and her close-knit family represent the human cost of poorly-tested medicines and lax regulations.

Where is the Duxbury case now?  What do you hope will be the outcome?

The case is in federal court but 80-year-old Judge Rya Zobel has severely limited it. Federal law allows whistleblowers to try and prove their claims of national fraud.  But Zobel has restricted this trial to just five alleged instances of fraud, all in Seattle. “It’s a mockery of justice,” said Schlichtmann. Experts agree that Zobel’s ruling will probably be overturned later, yet Schlichtmann must try his case in 2012.

Whether he wins or loses, Schlichtmann will appeal until he’s allowed to press his entire case. He’ll try to prove that J&J promoted Procrit illegally for years on a nationwide basis. The evidence is astonishing and, naturally, I’m rooting for Schlichtmann.

In all your interviews, what one thing shocked you the most?

I’ve been appalled to see how little power patients have in this process. Amgen, J&J, hospital chains and doctors all played a roll in epo’s shameful overuse. But the sick and vulnerable were the last to be heard. In this case, the system favored the financial interests of a few over the heath and safety of millions.

What have you learned from writing this story?

BLOOD FEUD taught me that the FDA’s approval stamp is not the Good Housekeeping seal that most of us think it is. Nor is the DOJ the tough cop who pursues big cases of taxpayer fraud that could retrieve desperately needed Medicare dollars. Procrit is a great example of how our consumer protection agencies have been emasculated by corporations, lobbyists and our own leaders. Even now, our regulators are being starved for funds.

Why is it important that this story be told?  Who needs to read this book?

BLOOD FEUD impacts anyone who’s ever taken a prescription drug or used a medical device—or more than 150 million Americans. This book sheds light on how we pay for the most expensive, inefficient health-care system in the developed world. But at its heart, BLOOD FEUD is really a suspenseful tale about ordinary people going to extraordinary lengths in their quest for justice. Duxbury, McClellan and the others never set out to cure our deeply flawed system. But they always believed they’d get a fair hearing. To this day, they’re still waiting….