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.

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.