Thursday, October 4, 2012

Victim of a medical mistake? Write a letter like this one!

Following is a letter I wrote and sent to Dr. Carolyn M. Clancy at the Agency for Healthcare Research and Quality.

TUCKER, GA 30084
PHONE: 770‑496-7607    FAX: 770-493‑7232

                                                                                                                        October 2, 2012

Dr. Carolyn M. Clancy
Agency for Healthcare Research and Quality
Office of Communications and Knowledge Transfer
540 Gaither Road, Suite 2000
Rockville, MD 20850

Dear Dr. Clancy:

 I read the New York Times story about your draft questionnaire requesting information about medical malpractice. If your questionnaire flyer is ready, please send one to me.

An electrophysiologist here in Atlanta gave me a death sentence when he prescribed amiodarone for me in four different violations of FDA guidelines. I didn’t have a life-threatening condition. The electrophysiologist and my pulmonologist are in agreement that amiodarone toxicity led to pulmonary fibrosis and the destruction of my lungs within five months. While pulmonary fibrosis is not a well known disease, it kills more people annually than breast cancer, according to one of the medical foundations created to help victims.

I’m a journalist by background – two degrees in English, one in journalism, Phi Beta Kappa, Phi Kappa Phi, from the University of Wisconsin. I’ve been a professor at the Universities of Wisconsin and Georgia. I’ve had 17 books published, five dealing with medical subjects. No. 18 is just about ready for release. It’s about medical malpractice and the pros and cons of using CT scans for early diagnosis of lung cancer. It also presents the case for and against the I-ELCAP research project of Dr. Claudia Henschke, who was forced out of Weill Cornell and is now affiliated with Mount Sinai Medical Center in New York.

If you would like to see more information about my case, visit the blog I set up to start publicizing book 19, which, if I’m given enough time before I die, will be about medical malpractice and amiodarone. The blog is at I’ll be adding to the base site soon as I begin writing copy for the next book.


/s/ Noel L. Griese

Noel L. Griese

Wednesday, May 9, 2012

I tell a dentist friend I'm the victim of yet another medical mistake

I have pulmonary fibrosis which doctors agree was caused by misprescription of a dangerous drug called amiodarone. In my case, the drug, which is supposed to be used only as a drug of last resort, was prescribed for a minor non-life-threatening condition. It caused pulmonary fibrosis, which is progressive and fatal. There is no treatment for PF. Following is an email I sent on May 9 to a dentists friend detailing yet another serious medical mistake.
                                                                  May 9, 2012
Barry -
I'm being infused for 28 days by an infectious disease doctor because of a strep viridans infection that was first diagnosed in late March but the lab work never reported to my personal doctor until early May. While I'm being infused is the ideal time for a dentist to work on me. That's the reason for looking for the old x-rays for comparison.
Kathie was the one pushing me to get copies of Dr. Ford's year-old x-rays that you have. I have no objections to a dentist/periodontist taking new x-rays for some that are almost a year old.
On March 21, I went to the Emergency Room at St. Joseph's Hospital in Atlanta (run now by Emory University Hospitals) on the orders of my pulmonologist. He wanted blood and urine work after I complained of chills and fever - my temperature was running from 95 to 103F.
The emergency room said that night after running the tests that there was nothing to worry about - just modestly elevated white blood counts indicating I was fighting an infection. They passed that report on to the pulmonologist next day. But then the Emergency Room at St. Joe's cultured the blood, and 3-4 days later diagnosed the strep viridans. Unfortunately, the St. Joe's Emergency Room didn't pass that on to the pulmonologist until I saw him routinely on May 1, more than a month after I'd been to the Emergency Room. I (or daughter Dawn who was with me) asked the pulmonologist on May 1 about what happened to the blood culture the Emergency Room doctor had said would be run. The pulmonologist then asked for a copy of the culture report from the Emergency Room, and on May 5 (a Saturday) the pulmonologist called to let me know about the strep diagnosis.
The problem with strep is that I have mitral valve leakage and the strep can attack heart valves. That can be fatal. The pulmonologist called me on May 5 and said he wanted me to go into the hospital immediately for treatment. I saw the infectious disease doctor on May 7. He said it would be enough for me to get an antibiotic daily for 28 days on an outpatient basis. The daily infusion treatment started on May 7, and I now have a picc line inserted in a main artery to permit the daily treatments.
This failure of the Emergency Room to report a serious diagnosis to my pulmonologist or, at the very least, to an infectious disease doctor, is just one more example of the out-of-control medical establishment in the U.S. Medical mistakes are the third leading cause of death in the U.S., after only heart disease and cancer. I'm dying of one such mistake, the misprescription of amiodarone which induced pulmonary fibrosis within five months.
Medical mistakes account for 200,000 fatalities per year in the U.S., with no progress made in reducing that number in the last 10 years. Hundreds of thousands more suffer needlessly each year because of medical mistakes. We're spending 17-18 percent of GNP in the U.S. on medical care - twice as much as any of the other developed nations. Our medical expenditures are approaching $3 trillion per year - and we're still making hundreds of thousands of medical mistakes annually. This is a dismal record!
Noel Griese
Anvil Brokers/Anvil Publishers, Inc.

Thursday, April 19, 2012

How the FDA let down America with a watered-down warning about amiodarone

This is a draft news release. Comments are welcome until it is finalized and distributed.

A highly toxic heart drug continues to be prescribed to millions of patients nationwide without the detailed consumer warnings promised by the U.S. Food and Drug Administration in 2003.

In late 2004,
the FDA required the makers of Cordarone and Pacerone, the then current brand names for amiodarone, to update their labels to include a black box with three important warnings:

1. This is a drug of last resort;
2. The drug results in 10-17 percent toxicity; and,
3. The drug results in 10 percent fatality.

Despite the fact that amiodarone kills one of 10 people who take it, the black box warnings stayed in effect for only a brief time before being watered down with less truthful labels dominated by legalese.

According to a story in the Nov. 24, 2004, Miami Herald, each dose or prescription of the drug amiodarone was supposed to include the new advisory that warned of its many risks and symptoms of fatal side effects and explained how the medication is supposed to be used. But the advisory, first discussed in October 2003, remained in draft form into late 2004, bouncing back and forth between the FDA and Wyeth,  the drug maker assigned by the FDA to write it.

The delay came in the midst of the FDA being questioned about its slowness in protecting Americans from potentially deadly drugs.

''How many people are dying right now as we speak as a result of their procrastination?'' asked Karen Muccino of Los Alamitos, Calif., whose father, John, died Feb. 20, 2004, of lung damage caused by amiodarone. Despite his training as an obstetrician, Muccino said her father never realized his dry cough was a symptom of a potentially fatal side effect of the drug.

John Muccino was taking amiodarone for atrial fibrillation, a common condition in which the heart beats out of rhythm. The FDA never approved the drug to treat that condition.

She said she was livid that the FDA did not immediately issue the patient warnings in the autumn of 2003. ''He would have been taken off the drug three months earlier and his life would have been saved,'' she said.

''What's happening with this drug goes to the heart of questions about how long it takes the FDA to act when known risks or dangers exist,'' Sen. Charles Grassley (R-Iowa) said at the time.

In October 2003, Dr. Janet Woodcock, who at the time ran the FDA's drug division, said the agency would take the rare action of requiring the advisory on all amiodarone prescriptions. Because of the dangers posed by the drug, Woodcock said the information would be written and distributed quickly, certainly by early 2004. ''Obviously this drug is a very risky drug,'' she said then.

The FDA initially approved amiodarone only for more severe disorders, and then only as a treatment of last resort. The approval was given without the drug undergoing clinical trials.

Patients taking amiodarone have for years right up to the present died from lung, thyroid and liver damage, gone blind or suffered from other side effects. The most common side effect is fatal lung damage. Yet, it is routinely prescribed for common heart rhythm problems despite the availability of safer alternatives.

According to 2004 data, doctors wrote more than two million prescriptions in a single year for atrial fibrillation and other heart conditions that amiodarone wasn't approved to treat. A Knight Ridder investigation in 2003 found that those prescriptions represented 82 percent of all the amiodarone dispensed from retail pharmacies during the 12-month period ending July 31, 2003.

In 2004, a class-action lawsuit was filed in New Jersey that accused drug makers of promoting branded versions of amiodarone for common heart ailments in an effort to boost their profits regardless of consequences for victims. The lawsuit contended that more than 1,000 people died, 100 had vision problems and thousands of others suffered severe medical complications from the branded versions of amiodarone.

U.S. drug companies initially marketed the drug under the trade names Cordarone and Pacerone. The drug rights for the Pacerone brand of amiodarone were initially held by Upsher-Smith Laboratories, and for the Cordarone brand by Wyeth-Ayerst Laboratories.

When a law firm tried to sue Wyeth in a class action, Wyeth and Upsher abandoned their brands, and the drugs went generic. The lawsuit was withdrawn. The generic drug amiodarone is now manufactured mainly in India and imported to the U.S.

By making the drug generic, the drug companies that were marketing amiodarone as Cordarone and Pacerone avoided class action litigation. The U.S. Supreme Court has ruled that the only causes of action a patient may take against a generic drug manufacturer is for a failure to warn if the generic drug does not copy the FDA-approved label exactly.

The FDA, meanwhile, had in 2003 asked Wyeth, the drug maker, to write a warning advisory for amiodarone prescriptions. Wyeth was given the job of writing the informational guide because it was the first company to sell the drug.

Wyeth spokesman Chris Garland said in 2004 that the FDA could approve the Wyeth advisory as early as December 2004.

In 2004, no one at the FDA would respond to written questions about the appropriateness of allowing a drug maker to be in charge of writing warnings that could reduce the drug’s sales, or whether the delays were excessive.

Dr. Valentin Fuster, the chairman of the American College of Cardiology's treatment guidelines committee for atrial fibrillation, said in 2004 that amiodarone shouldn't be the first drug a doctor tries when treating fibrillation. ''You don't use amiodarone as a drug for this except after everything else fails,'' he said.

Knight Ridder found that patients routinely got little information about its risks or alternative therapies. Over the years, the FDA has cited various manufacturers for downplaying the drug's risks and for promoting it as a first-line therapy.

In 2011, a Texas lawyer, Justin Williams, filed an action in which his firm first went to the FDA website looking for labeling information.  The FDA requirements for complete labeling by manufacturers were not available at the FDA site. What his firm eventually found was that manufacturers of generic amiodarone had updated their labels in 1998, 2000, and 2002, with no other updates until 2010.

Williams concluded from labels he had obtained from various victims of amiodarone poisoning and their family members that the targets in the lawsuit had failed to update their labels with appropriate warnings, so at they could be sued.

Williams filed suit and says he immediately became involved in one legal battle after another. The offshore companies making and marketing amiodarone hired one of the most aggressive, expensive and “win at all costs no matter what justice is” law firms in America.

The manufacturers produced labels from the years after the FDA required modifications after the initial black box warning. They produced labels Williams did not have from prior years that had the required warnings.

The unfortunate truth is most cardiologists and electrophysiologists who prescribe amiodarone don’t believe the watered-down warnings that come with amiodarone. They think the warnings are "just stuff the lawyers require." Many do not tell patients about the warnings and dangers because they have been bought off or brainwashed by drug companies to think the side effects will never happen to their patients.

Representative Henry  Waxman (D-Calif.) is currently trying to get a law passed to give the same rights to sue the makers of generics as victims have to sue the makers of brand name drugs.

Thursday, April 12, 2012

How the medical professionals responsible for 200,000 deaths per year are protected

It's no secret that medical mistakes are the third leading cause of deaths in the U.S., behind only heart disease and cancer. For the past decade, an estimated 200,000 Americans have died annually of medical mistakes. Hundreds of thousands more suffer needlessly because of such mistakes. There has been almost no progress made in improving on these dismal statistics.

A big part of the reason is the medical profession's penchant for protecting doctors, especially the bad ones who cause the most problems. The American Medical Association, its state affiliates and the lobbyists funded by this powerhouse have done everything in their power to protect the doctors and other medical professionals responsible for what amounts to 200,000 annual cases of manslaughter.

One of the supposed deterrents to medical malpractice are the"ethics hotlines" operated by most hospitals. Employees are supposed to call these in-house lines to report observed cases of suspected malpractice.

I recently had a procedure performed by a medical technician. To protect her identity, let's call her "Peggy."

Peggy now works at a hospital in the Atlanta area. Her prior employer was Crawford Long Hospital in Atlanta. It's a hospital that was started by a doctor named Crawford Long. Since the early 1990s, it's been the property of and operated by Emory University Hospitals. The hospital's name was recently changed from Crawford Long to Emory Midtown as part of a rebranding.

Peggy observed a case of what she considered malpractice. She saw a doctor bullying a not very knowledgeable older female patient into having an unnecessary surgery performed immediately. She called the Crawford Long ethics hotline to report the details. She was told it was a doctor-patient issue and to stay out of it. Discouraged, and fearful of losing her job, she clammed up.

That's one example of the way nurses, who often see ethical and malpractice violations by doctors, are intimidated by a now thoroughly corrupt system of healthcare. I say thoroughly corrupt because of the billing dishonesty and corruption that now goes on across the board as doctors, hospitals and charlatans who are in the business of fraud try to game or outright cheat the cumbersome  reimbursement system operated by private health care insurers and the federal Medicaid and Medicare systems.

I can speak firsthand about fatal medical mistakes. Dr. Stephen Prater, an Atlanta electrophysiologist, prescribed a drug called amiodarone for a non-life-threatening condition for me. He initially said my minor premature ventricular contractions required no treatment. When I came for a second appointment, however, during which there was no change in my condition, he decided to prescribe amiodarone "to improve my quality of life." He prescribed it without any warning of its extremely dangerous side effects, and without any baseline testing - both violations of Food & Drug Administration recommendations. Within five months my lungs were destroyed by pulmonary fibrosis, a progressive and fatal disease. The specifics are detailed in other posts on this Web site.

Nurses played a key role in persuading the electrophysiologist who put me on amiodarone that I was suffering from amiodarone poisoning. I'd suggested at a January 2011 appointment with Dr. Prater that I should be tested for amiodarone toxicity. He didn't think that necessary until three nurses ganged up on him in February. Only then did I get a phone call from his assistant saying the doctor thought I should stop the amiodarone. Turned out I had developed fatal pulmonary fibrosis from the amiodarone. Dr. Prater has never apologized for unnecessarily poisoning me. 

My freelance writer friend Randy Southerland of Atlanta observes, "There is a 'no blame' culture in medicine today. The idea is that if people are not punished for mistakes they are more likely to report them. Now some third party payers are moving toward refusing to pay for treatment for so called 'never events' - (such as) operating on the wrong body part, (or) adverse drug reactions. (There is a long list compiled since 2001.) The hospital doesn't get paid for fixing the problem and they are not allowed to bill the patient or anyone else for (such events). The result is that mistakes start to go down where there are financial consequences for making them. The same thing happens when success rates are public knowledge."

Randy's observations are valid, but I would argue that the 'no blame' culture for which AMA lobbyists have argued at great expense to the medical consumer has done little to nothing to improve a broken system. If a doctor kills someone through his or her fault, I say the way to improve the system is to litigate.

Monday, March 26, 2012

A letter to Dr. Jeffrey Kluger of Hartford, CT, about amiodarone poisoning

I have invited Dr. Kluger to respond to points made in my letter to him below. When I receive his comments, I will post them here.

Jeffrey Kluger, M.D.
Director of Heart Rhythm Management
Department of Cardiology Practice
Hartford Hospital / Cardiology
PO Box 5037
Hartford, CT 06102-5037

Dear Dr. Kluger:

On June 29, 2010, I was prescribed amiodarone for asymptomatic non-life-threatening premature ventricular contractions (PVCs) by electrophysiologist Dr. Stephen Prater of Atlanta. Local doctors, including Dr. Prater who prescribed the drug, say the amiodarone caused my pulmonary fibrosis (PF), a disease that developed within five months after the drug was prescribed. PF is progressive and fatal, usually within two to four years.

You were asked by Jennifer Motley, M.D., of Atlanta, to provide an expert opinion on whether the amiodarone was an appropriate standard of medical care, or if it was inappropriately prescribed. You were paid for your opinion by the Warshauer Group of Atlanta, with which Dr. Motley is affiliated. In a letter to me, Dr. Motley summarized your analysis as follows: “Our consulting expert, Dr. Kluger, is an electrophysiologist who has done research with Amiodarone. He reviewed your records and found the care you received was lacking in one main respect. Dr. Kluger felt that prescribing you amiodarone initially was a judgment call by Dr. Prater and not outside of the standard of care. However, he felt it was inappropriate for Dr. Katz not to stop the amiodarone in December and evaluate you for pulmonary toxicity at that time, as symptoms had already developed. That being said, he pointed out that you had a pulmonary process that predated the amiodarone. There is clearly evidence of this pulmonary condition in 2002…”

It’s particularly interesting that Dr. Prater, in January 2011 immediately after Dr. Katz in December 2010 took no action, also declined to stop the amiodarone. He also saw no particular need to evaluate me himself or arrange for an accelerated appointment with a pulmonologist in that appointment.

As you no doubt know, medical mistakes in the U.S. account for an estimated 200,000 fatalities per year, and suffering without immediate death for hundreds of thousands more. Medical mistakes are the third leading cause of death in the nation, after only heart disease and cancer. Little to no progress has been made by the medical profession in these deplorable statistics in the past ten years.

Since your opinion is counter to that of a number of local doctors, I hope you’ll clarify it. I’m collecting information about amiodarone for a book. I spent much of my life as a newspaper reporter and editor, and journalism professor at the Universities of Wisconsin and Georgia. Over the years, I’ve had thousands of articles and 17 books published. Five of the books deal with medical subjects, cancer in particular. I’m a past state director of the American Cancer Society, the American Lung Association, and several other health charities.

My goal in writing about amiodarone, if I live long enough to finish it, is to alert the public to the damage being done by cardiologists and electrophysiologists unnecessarily prescribing this dangerous drug. I hope to make the public more aware of how amiodarone entered the American medical scene without clinical trials overseen by the Food and Drug Administration.

You were likely unaware of my particular circumstances when you rendered your paid opinion. So let me provide those details, please, and invite your further comment. I want to get the story right. If anything I say below is incorrect, please let me know promptly so I can include your corrections in my account. If, on the other hand, I’m right and your opinion is wrong, there’s only one way for you to repair that - and that’s by correcting your initial opinion. If you agree that you were wrong after reading this, you will know the right and ethical thing is to do.

First, let me cover how the amiodarone came to be prescribed for me. I had a quintuple bypass in July 2009. The surgery was successful, and the surgeon who performed it said it should give me another ten years of life expectancy - out to the year 2019.

In the spring of 2010, I began a cardiac rehabilitation program at Piedmont Hospital in Atlanta. While taking the course, my heart was monitored for two hours twice weekly.

After several of these cardiac classes, a nurse named Joann Gorrell of Piedmont Hospital on May 10, 2010, notified my cardiologist, Dr. Stuart Katz, that I was having asymptomatic premature ventricular contractions. Note the nurse’s use of the word asymptomatic - I had no life-threatening symptoms such as dizziness or blacking out. She wanted the cardiologist to see me before I went further in the course. Dr. Katz referred me to the electrophysiologist, Dr. Prater.

In my first visit with Dr. Prater on June 2, 2010, he said the PVCs were not life-threatening and required no action. The PVCs were some doubles and an occasionally triple when I exerted myself on exercise machines. I had no quintuples or above, which Dr. Prater said could be life-threatening. So Dr. Prater, the electrophysiologist who eventually prescribed the amiodarone for me, himself admits that prescribing it  was inappropriate in my case, and contrary to reasonable care. As I usually do at meetings with physicians, I taped the session on a microcassette with Dr. Prater’s permission, and my wife was present with me at the appointment, as she is at almost all my medical appointments.

Unfortunately for me, the nurses at Piedmont insisted that I go back to Dr. Prater because I continued to have the minor PVCs during exercise. I had my second appointment with Dr. Prater on June 30, 2010. This time he prescribed 200 mg of amiodarone for me “to improve my quality of life.”

Based on my research to date, amiodarone is most appropriately prescribed in cases of atrial fibrillation, not the non-life-threatening PVCs I was experiencing. It seems pretty obvious to me that the prescription was to blow me off so the nurses at Piedmont Cardiology would stop sending me to bother him. I also taped this session with Dr. Prater, and my wife was present.

No baseline testing as recommended by the FDA, not even the taking of a chest x-ray, was done at the time the amiodarone was prescribed. Nor was I given any warning by the doctor of the dangerous side effects of the drug.

My quality of life before the amiodarone was prescribed was great - I was something of a gym rat, and I was working out regularly not only at Piedmont Cardiac Rehab but at the Bally’s near my home.  Aside from gym exercise like swimming, weight lifting and machine aerobics at Bally’s, I was mowing the grass at home and cutting down trees with my chain saws. I was traveling when and where I wanted. But that would not go on for long.

By Thanksgiving in November 2010, only five months after I began taking the amiodarone, I was beginning to have trouble breathing.

In December 2010, I had an annual physical with cardiologist Dr. Stuart Katz. At the time, I pointed out to him and his nurse Lisa not only my breathing difficulties, but the blueness (cyanosis) around my fingers. I specifically asked him if the amiodarone could be the cause of my breathing difficulties and cyanosis. He didn’t think so. It turned out, he told me later, that he didn’t know the symptoms of amiodarone poisoning even though he bills himself as a cardiologist. He ordered no appropriate tests to determine if I was suffering from amiodarone toxicity, and so far as I know, he did not notify Dr. Prater who was in the same practice at the Piedmont Heart Institute. I taped the session with the permission of Dr. Katz.

Between the December 16, 2010, appointment with Dr. Katz, and the January 17, 2011, appointment with Dr. Prater, my wife and I began talking about our concerns with two well respected nurses who live in our neighborhood.

At the January 17, 2011, appointment, I informed Dr. Prater about the shortness of breath and cyanosis, asking if amiodarone could be at fault. Dr. Prater was still in denial about the amiodarone. He thought it was still good for me, despite the drug’s history of causing life-threatening pulmonary, thyroid, vision and other problems. He suggested that I reduce the dosage from 200 to 100 mg. daily. Thinking that something else might be the cause of my pulmonary problems (such as congestive heart disease, which I did not have - an echocardiogram indicated my rebuilt heart was as good as an astronaut’s), he suggested that I see a pulmonologist. I made an appointment with Dr. Kenneth Melby of the Atlanta Pulmonary Group for January 31, 2011.

In his report on my January 31 appointment with him, Dr. Melby says I had no prior history of lung disease before the appointment. Dr. Melby took two x-rays on January 31, and showed me shadows in the lower quadrants of my lungs indicating significant fibrotic damage to the lower part of both my lungs.  He was not sure what had caused the anomalies, but wanted me to come back to see him.

On February 7-8, three nurses - one from our neighborhood, one the nurse for Dr. Victor E. Corrigan (Dr. Corrigan did the catheterization before my bypass surgery), the third Dr. Prater’s own assistant, ganged up on him, saying I had all the symptoms of amiodarone poisoning. On February 8, I received a phone call from Dr. Prater’s assistant Michell saying Dr. Prater wanted me to discontinue the amiodarone. By that time, the damage was done. I’d been unnecessarily given a death sentence to quiet down an anxious cardiac rehab nurse.

Now, let’s consider the interstitial lung disease dating to 2002 that you mention.

I’ve had annual chest x-rays plus other x-rays and CT scans over the years from 2002 through 2010. Not once did a physician ever mention that I was showing any signs of lung disease. Not until I saw Dr. Leslie Watters of the Atlanta Pulmonary Group on July 26, 2011, did any doctor ever mention any symptoms of pulmonary disease dating to 2002. Dr. Watters was the first. Dr. Katz, who would have received the analysis of my annual physical chest x-rays, never once mentioned any signs of interstitial lung disease on my annual physical and other chest x-rays. His partner, Dr. Steinberg, who I occasionally saw, never mentioned it. Dr. Victor E. Corrigan, who did two heart catheterizations on me over the years, never mentioned it. Dr. John Gott, the surgeon who did the quintuple bypass on me in July 2009, and who had access to extensive chest x-rays and other scans taken before and after the surgery, never mentioned it. The logical conclusion is that none of these doctors thought I had any pulmonary symptoms worthy of mention in the period 2002-2010.

In an appointment I had with pulmonologist Dr. Kenneth Melby on August 11, 2011, Dr. Melby told me that he and Dr. Prater were in agreement that my pulmonary fibrosis was the result of amiodarone toxicity. By this time, Dr. Melby had left the Atlanta Pulmonology Group and joined another practice. I was continuing to see him, but also began seeing Dr. Leslie Watters of the Atlanta Pulmonology Group.

As you know, Dr. Kluger, there is no treatment or cure for pulmonary fibrosis. The only possible action is a lung transplant. Drs. Melby and Watters referred me to the Emory University McKelvey Center for Lung Transplantation in Atlanta, the only institution in Georgia that does lung transplants. I had my first appointment with Dr. David Neujahr of the transplant center on October 4, 2011. The upshot was that Emory has never done a transplant on anyone over seventy years of age because of low life expectancy following the transplant(s). I’m seventy-four. However, Dr. Neujahr did indicate that Emory considers amiodarone as a dangerous drug that should only be prescribed in extenuating circumstances. My circumstances were not extenuating.

I wanted validation from a second electrophysiologist about the appropriateness of amiodarone being prescribed for me. I checked with a number of resources, and the name that came up as someone I could trust was Dr. David Wilson, an electrophysiologist who practices in Lawrenceville, Georgia., and at St. Joseph’s Hospital in Atlanta, where the Atlanta Pulmonology Group offices are located. I had my first appointment with him on October 12, 2011. At that appointment, which I taped, and at which my wife was present, Dr. Wilson emphasized that he would not have prescribed amiodarone for me based on the EKG strips from my sessions at the Cardiac Rehabilitation Program at the Piedmont Hospital Fuqua Heart Center. So we have a respected electrophysiologist who disagrees with you that Dr. Prater’s prescription of amiodarone was appropriate for me and within the standard of care. You say that it is your opinion that “prescribing you amiodarone initially was a judgment call by Dr. Prater and not outside of the standard of care.”  At least one of your peers disagrees with your conclusion.

One of the unfortunate things about amiodarone is that cardiologists are freely prescribing this dangerous drug for many off-label, non-life-threatening conditions, and failing to warn the people who get the prescriptions of the dangerous side effects of the drug. That leaves the pulmonologists having to clean up the messes created by these physicians prescribing amiodarone for all sorts of off-label conditions .

On February 21, 2012, I had an opportunity to attend a two-hour discussion with Dr. Remzi Bag, M.D., who is now medical director of lung transplantation at Emory University Hospitals’ McKelvey Center. Before coming to Emory, Dr. Bag served as chief of the lung transplant and pulmonary hypertension division of INTEGRIS Baptist Medical Center in Oklahoma City, Oklahoma. He also has served as the director, lung and heart-lung transplant programs, at St. Luke’s Episcopal Hospital, and as director, pulmonary transplant program, at Baylor College of Medicine and The Methodist Hospital in Houston.

Asked about amiodarone at that session, Dr. Bag responded that cardiologists and electrophysiologists like you seem to think the drug is harmless and a great boon, but it is the pulmonologists who are left with no option other than lung transplants to repair the damage often unnecessarily done by amiodarone. It would appear that Dr. Bag’s credentials are at least equal to if not considerably in excess of your own expertise.  So when you conclude in my case that “prescribing you amiodarone initially was a judgment call by Dr. Prater and not outside of the standard of care,” you will forgive me for questioning the accuracy of your statement. It sounds to me - my opinion, admittedly - that you are trying to protect the rear end of another electrophysiologist.

Let me conclude with various FDA recommendations and warnings to physicians prescribing amiodarone - recommendations and warnings that are being widely ignored either deliberately or out of ignorance by physicians.

·         There have been post-marketing reports of acute-onset (days to weeks) pulmonary injury in patients treated with oral amiodarone with or without initial I.V. therapy. Findings have included pulmonary infiltrates and/or X-ray, pulmonary alveolar hemorrhage, pleural effusion, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia. Some cases have progressed to respiratory failure and/or death. Post-marketing reports describe cases of pulmonary toxicity in patients treated with low doses of amiodarone; however, reports suggest that the use of lower loading and maintenance doses of amiodarone are associated with a decreased incidence of amiodarone-induced pulmonary toxicity.

·         Amiodarone hydrochloride tablets may cause a clinical syndrome of cough and progressive dyspnea accompanied by functional, radiographic, gallium-scan, and pathological data consistent with pulmonary toxicity, the frequency of which varies from two to seven percent in most published reports, but is as high as ten to seventeen percent in some reports. Therefore, when amiodarone therapy is initiated, a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, should be performed. The patient should return for a history, physical exam, and chest X-ray every three to six months. (None of these underlined recommendations were observed in my case.)

·         Patients with preexisting pulmonary disease have a poorer prognosis if pulmonary toxicity develops. (I was never told I had any pre-existing pulmonary condition - but surely if it was there, Dr. Prater would have been aware of it, is that not correct?)

·         Interstitial/alveolar pneumonitis may result from the release of oxygen radicals and/or phospholipidosis and is characterized by findings of diffuse alveolar damage, interstitial pneumonitis or fibrosis in lung biopsy specimens. Phospholipidosis (foamy cells, foamy macrophages), due to inhibition of phospholipase, will be present in most cases of amiodarone-induced pulmonary toxicity; however, these changes also are present in approximately fifty percent of all patients on amiodarone therapy. These cells should be used as markers of therapy, but not as evidence of toxicity. A diagnosis of amiodarone-induced interstitial/alveolar pneumonitis should lead, at a minimum, to dose reduction or, preferably, to withdrawal of the amiodarone to establish reversibility, especially if other acceptable antiarrhythmic therapies are available. Where these measures have been instituted, a reduction in symptoms of amiodarone-induced pulmonary toxicity was usually noted within the first week, and a clinical improvement was greatest in the first two to three weeks. Chest X-ray changes usually resolve within two to four months. According to some experts, steroids may prove beneficial. Prednisone in doses of 40 to 60 mg/day or equivalent doses of other steroids have been given and tapered over the course of several weeks depending upon the condition of the patient.

·         In a patient receiving amiodarone, any new respiratory symptoms should suggest the possibility of pulmonary toxicity, and the history, physical exam, chest X-ray, and pulmonary-function tests (with diffusion capacity) should be repeated and evaluated. A fifteen percent decrease in diffusion capacity has a high sensitivity but only a moderate specificity for pulmonary toxicity; as the decrease in diffusion capacity approaches thirty percent, the sensitivity decreases but the specificity increases. A gallium-scan also may be performed as part of the diagnostic workup.

·         Fatalities, secondary to pulmonary toxicity, have occurred in approximately ten percent of cases. However, in patients with life-threatening arrhythmias (I did not have life-threatening arrhythmia), discontinuation of amiodarone therapy due to suspected drug-induced pulmonary toxicity should be undertaken with caution, as the most common cause of death in these patients is sudden cardiac death. …

·         If a diagnosis of amiodarone-induced hypersensitivity pneumonitis is made, amiodarone should be discontinued, and treatment with steroids should be instituted. If a diagnosis of amiodarone-induced interstitial/alveolar pneumonitis is made, steroid therapy should be instituted and, preferably, amiodarone discontinued or, at a minimum, reduced in dosage. Some cases of amiodarone-induced interstitial/alveolar pneumonitis may resolve following a reduction in amiodarone dosage in conjunction with the administration of steroids. In some patients, rechallenge at a lower dose has not resulted in return of interstitial/alveolar pneumonitis; however, in some patients (perhaps because of severe alveolar damage) the pulmonary lesions have not been reversible.

I eagerly await your comments


/s/ Noel L. Griese

Noel L. Griese


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Monday, January 16, 2012

I'm diagnosed with pulmonary fibrosis due to amiodarone toxicity

On August 11, 2011, I was given what amounts to a death sentence. I was told I had been diagnosed with pulmonary fibrosis induced by amiodarone toxicity. 

Pulmonary fibrosis is progressive, and there is as yet no treatment for curing it. Normal prognosis is death in two to four years. Often death comes faster, especially when the fibrosis is caused by amiodarone poisoning. It is rare for someone with pulmonary fibrosis to survive for five years or more. 

Pulmonary fibrosis is a scarring of the tissue in the lungs. As pulmonary tissue hardens, it becomes increasingly difficult for the alveoli of the lungs to re-oxygenate blood supply. The victim eventually dies of oxygen deprivation.

There are several medicines that hold promise for slowing the progression of the fibrosis. One is an over-the-counter antioxidant called L-Cysteine Hcl. I'm taking six hundred mg. of that three times a day. There's also a clinical trial just launched for a drug already in use in Europe called pirfenidone (being marketed in Europe as Ebriet). Atlanta is one of the centers for the clinical trial, and I'm in the process of enrolling.

The only remedy for a fibrotic lung is a lung transplant. For that, transplant centers use a one hundred-point scoring system to determine who gets transplants. People over sixty-five―that includes me, at seventy-three―seldom score high enough to get a transplant. But there are exceptions. One of the men in my pulmonary fibrosis support group at Piedmont Hospital is in his early 70s and just got a double transplant. I'm in the process of being evaluated and scored by Emory University Hospitals in Atlanta, the local lung transplant center.

How did I get pulmonary fibrosis?

In July 2010, an electrophysiologist in a group practice in Atlanta prescribed 200 mg. daily of amiodarone for me. The purpose was to control non-life-threatening premature ventricular contractions of my heart. 

The electrophysiologist did not warn me that amiodarone is a deadly poison for seventeen percent of the population. He did not follow U.S. Food and Drug Administration guidelines in prescribing the medication―the FDA says it’s to be used only in life-threatening situations, and then only as a treatment of last resort.

Already by November 2010, family members were noticing the shortness of breath that had overtaken me so gradually that I didn’t recognize it.

By December 2010, when I had an annual physical with a cardiologist at the same practice as the electrophysiologist, I complained of shortness of breath and cyanosis around my fingernails, both symptoms of amiodarone poisoning. In amiodarone poisoning, cyanosis―a blue coloration indicating oxygen deprivation in the blood―occurs around the fingernails. 

The cardiologist who saw me that day didn’t connect the obvious symptoms of amiodarone poisoning with the symptoms I was displaying, although he knew I was taking amiodarone. 
The cardiologist took two chest x-rays as part of my physical, and the radiologist who read them noted the beginnings of interstitial lung disease―but no warning came to me of what the radiologist saw.

By January 2011, I was becoming increasingly aware of my declining lung capacity and difficulty breathing. My wife Kathie and I began to talk to nurses who lived in our neighborhood, asking if they had any ideas of what could be causing my breathing difficulties. We still hadn't figured out that I was suffering from amiodarone poisoning. But the nurses did. Three of them―including his own assistant―ganged up on the electrophysiologist in early February 2011 and told him they thought I had amiodarone poisoning. He  told his assistant to call me to tell me to stop taking the amiodarone―without any explanation of why.

When I had a follow-up appointment in the spring of 2011 with the cardiologist, and told him that the electrophysiologist had discontinued the amiodarone in February, the cardiologist went back to the radiologist’s description of my December chest x-rays and finally saw the warning about the developing interstitial lung disease―another term for idiopathic pulmonary fibrosis.

I was soon thereafter given an echocardiogram that ruled out congestive heart disease as the cause of my symptoms. The technician who administered that test told me my heart was as good as an astronaut’s. Chronic obstructive pulmonary disease (COPD) was also ruled out.

On August 11, 2011, the pulmonologist I was seeing told me that he and the electrophysiologist had discussed my case and agreed that what I had was pulmonary fibrosis brought on by amiodarone toxicity.

So there you are. Based on the longevity of males in my family, I should be expecting another ten  years of healthy, enjoyable life. But that is not likely now. 

I certainly won’t be the first person to die of amiodarone poisoning. There are many cases on record. I may discuss a few of them in future postings on this blog. I don’t know how many postings there will be, because I don’t know how often I will write a post, or more importantly, how much time I have left to write them.

Most of us don’t know when death will come. As a result, we fail to do many things that need to be done to protect those we love and leave behind.

I’ve been giving a lot of thought to the things that need to be done―to the physical things like writing a will (that’s done), and to the spiritual things like preparing the spirit for the crossing over (not done yet, but I’m working on it).

Hopefully, in future posts, I can provide information of both a pragmatic and spiritual nature that will be helpful to others facing the same predicament as me.