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.

custserv@anvilpub.com

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.

The strange history of amiodarone

As I've noted in other posts, I'm dying of pulmonary fibrosis caused by amiodarone toxicity. Amiodarone is a drug that the U.S. Food and Drug Administration recommends for use only in life-threatening situations. An electrophysiologist prescribed the drug for me for a non-life-threatening condition―occasional premature ventricular contractions that posed no danger to my life.

According to About.com Guide Dr. Richard N. Fogoros, M.D., amiodarone, sold under the brand names Cordarone and Pacerone, is the most effective, and certainly the strangest, antiarrhythmic drug ever developed. 

One of the strangest aspects of the drug is its history. It is a history that explains much about why, to this day, many of the more unusual features of the drug are poorly understood by many doctors who prescribe it. 

Amiodarone was developed by a Belgian company in 1961 as a drug for treating angina (chest discomfort related to coronary artery disease), and quickly became a popular anti-angina drug in Europe and South America. However, by the choice of the drug company (probably to avoid the unusually tough American regulatory environment), amiodarone was not offered for release in the United States. 

After a few years a physician in Argentina, Dr. Mauricio Rosenbaum, noticed that amiodarone seemed to reduce cardiac arrhythmias in his patients with heart disease. He began using the drug extensively for heart rhythm disturbances, and then began to publish his results, which were extraordinarily impressive. Clinicians from all over the world (except in the United States) quickly began using the drug to treat cardiac arrhythmias of all sorts. The reputation of amiodarone spread far and wide―amiodarone, the word was, was a unique antiarrhythmic drug that almost always worked, and had virtually no side effects. 

Both of these assertions, of course, proved false.

Beginning in the late 1970s, American electrophysiologists (heart rhythm specialists) began to obtain amiodarone from Canada and Europe to use in their patients with life-threatening arrhythmias who did not respond to any other drugs. The Food and Drug Administration (FDA), the federal agency that oversees drug safety, sanctioned this activity on a compassionate-use basis. 

The early word from Americans seemed to confirm what was being said all over the world―amiodarone was very safe and very effective. Electrophysiologists by the early 1980s were driving to a customs office to clear a foreign shipment of amiodarone, provided free by the Belgian drug company. 

Within a few years, more than 10,000 American patients with potentially lethal arrhythmias were estimated to be receiving amiodarone. Of course, because of the way amiodarone was being distributed, nobody really knew how many patients were receiving the drug. More importantly, because the FDA was not involved in any of this, except to approve of the use of the drug for compassionate reasons, nobody was compiling information on the drug's effectiveness or safety. 

However, many American doctors studied the effects of amiodarone on their own patients somewhat more rigorously than their overseas colleagues had done. As a result, within a year or two the view of amiodarone began to change. 

Amiodarone was indeed more effective at suppressing arrhythmias than any other drug, though by no means as effective as had been advertised, but it produced a bizarre series of side effects―including difficult thyroid disorders, skin discoloration, and potentially life-threatening lung toxicity―that doctors around the world seemed to have missed. The side effects had been missed, for the most part, because they were so unusual and unexpected, and because their onset tended to be insidious and late. 

When the side effects of amiodarone began to be described in medical publications, the FDA became reluctant to approve the drug. However, the FDA soon had little choice. In the mid-1980s, the foreign manufacturers of amiodarone threatened to cut off the American supply. Simply cutting Americans off from the drug would produce a medical (and hence, possibly a political) disaster. So, in 1985, in sharp contrast to any other drug in modern history, amiodarone became FDA-approved without rigorous FDA-sanctioned randomized clinical trials.

Respectful of the drug's newly discovered and very troublesome toxicity, the FDA approved the drug only for life-threatening arrhythmias for which no other treatment was feasible. 

The FDA urged the manufacturers to conduct randomized clinical trials to gain formal approval for indications such as atrial fibrillation, noting that conducting such trials would teach us much about true incidence and seriousness of the drug's side effects. Those trials were never done―possibly because such trials are very expensive, and by this time the patent on amiodarone was expiring, opening the door for generic manufacturers to begin selling it―and the original restrictions on the use of amiodarone have persisted to this day. 

The strange history of amiodarone may explain why some doctors who prescribe this drug seem unaware of the breadth and the subtle nature of many of its side effects―and why some of them do not adequately monitor their patients who take amiodarone, or fully inform their patients as to what to watch out for.