Archive for September, 2007

The FDA and Clinical Trials

Sunday, September 30th, 2007

Attacked in a report by the HHS Office of Inspector General (OIG), The Food and Drug Administration does not know how many clinical trials are going on at any given time, how many sites are conducting them, and how many institutional review boards (IRBs) are overseeing them. According to this Government report just released, (Sept. 28) the FDA audited fewer than 1% of the testing sites and, according to the New York Times, when inspectors did appear, they generally showed up long after the tests had been completed. The FDA has 200 inspectors to police some 350,000 clinical testing sites, so it’s not surprising that that many of them audit sites only part time. Privately financed noncommercial trials have no federal oversight whatsoever.

The breathtaking shock is that cats and dogs get better protection as research subjects in the U.S. than human beings. Animal research centers have to register with the Government, must keep track of subject numbers, have unannounced spot inspections and take care of problems or face closing, none of which applies to human drug or medical device trials. Perhaps we should persuade PETA to join the HHS in exposing the FDA.

This Inspector General report assailing the FDA makes one wonder about the overall reliability of some studies coming out of thousands of medical facilities, many reported in respected peer-reviewed medical journals. The media, feeding off this literature, helps drive the public appetite for more and more medical news advertised as “scientific breakthroughs.”

What’s My Diagnosis, Doc?

Tuesday, September 25th, 2007

Just because your doctor has a name for your condition
doesn’t mean he knows what it is.

Six Principles for Patients
Murphy’s Law, Book 2

More than 1.2 billion patient visits to U.S. physicians, hospitals, and ER’s in the past year were recently analyzed in the latest NCHS report of August 2007 . If you discount re-visits, chronic illness, routine follow-up, preventive, and visits for injuries, and poisonings, 75% did so because of a symptom or specific complaint(s). A vast medical literature indicates that certain complaints, often described as “unexplained” are exceedingly common in the general population.

Large studies have shown that up to 80% or more of all healthy people (including you and me, Dear Reader) experience at one time or another a virtual mixed salad of unexplained bodily symptoms. Among the most common ingredients are: fatigue, weakness, irritability, faintness or dizziness, atypical headaches, an endless variety of joint and muscle pains, nasal congestion, insomnia, sleepiness, brief tinnitus, unexplained attacks of itching, transient weight loss, nausea, constipation, diarrhea, sweating, etc. The list is virtually endless. What most of these complaints have in common is their strange unprovoked, and often short-lived appearance, their anatomic inconsistencies, their failure to conform to any well-defined syndromes or disease entities, and most important of all, their usually benign clinical course. Persistent or recurrent flavors of these and other complaints fall under the veil of psychiatric illness, but most of us are not “emotionally challenged.”

What Indeed is in a Name, Juliet?

Seeking diagnostic perfection, doctors and patients alike feel comfort in the delusional certitude that naming is knowing and knowing is curing. Yet by the overwhelming need to give a name to every clinical presentation doctors as well as patients are the cause of much medical mischief. Among those of us who constantly visit doctors with unexplained physical complaints, many are unhappy or dissatisfied with their physicians. An increasingly large number of these patients are subjected to extensive “workups,” needless, often expensive, even dangerous testing, multiple physician visits, consultations, and “doctor shopping.” Some fear they have cancer or some other potentially fatal illness. Others regard a referral to a psychiatrist as dismissive of their concerns.

As I have mentioned in a previous Second Opinions Newsletter, “…It is possible, as many psychiatrists observe, that neurotics more often tend to feel problems in their bodies rather than in their psyches, but overwhelmingly, we are all of us susceptible to unexplained somatic complaints. As observing clinicians gradually learn, (though are almost never taught) do not to take everything too seriously too soon. This requires a sixth sense for the significant.

A seasoned and wise clinician, when confronted with banal complaints, or even the bizarre or clinically unexplainable, in an obviously well patient, should be able to say, “We see this; it will go away.”

P.S. All I seem to be getting lately is spam disguised as “comments.” How about some genuine comments?

A Medical Anecdote

Thursday, September 13th, 2007

The late 19th Century German poet Otto Hartleben was feeling quite ill and consulted a physician who, after a thorough examination, prescribed complete abstention from smoking and drinking. Hartleben picked up his hat and coat and started for the door. The doctor called after him, “My advice, Herr Hartleben, will cost you 3 marks.” “But I’m not taking it,” retorted Hartleben, and he vanished.

The Cascade Effect

Wednesday, September 5th, 2007

The problem of abnormal or incidental findings leading to an uncontrollable series of unforeseen events, is described as The Cascade Effect. Such findings, found on routine exams, more often on screenings (see last post on incidentalomas) most frequently result from ill-advised diagnostic testing, and are almost always without medical significance. Yet they can result in a series of extensive and risky diagnostic procedures culminating in clinical catastrophes.

Cascade fiascos are frequently catalyzed by anxiety on the part of the patient or his physician, and are becoming increasingly more common in clinical practice because of the introduction of new and ever more pervasive technologies along with uninhibited and unjustified medical testing.

Here’s one example:

A 35 year old nurse underwent abdominal ultrasound for vague GI symptoms. The study was negative except for the incidental discovery of a small liver “lesion.” She was told, “It might be serious,” and a biopsy was suggested. Over the next several weeks she developed a serious depression, and consulted a psychiatrist. A CT was nondiagnostic, so she ended up having hepatic angiography, a invasive procedure, not without risk, in which dye is injected into a major artery leading to the liver. A diagnosis of “benign hemangioma” was finally made. This is a tiny localized collection of blood vessels seen in over 2% of the population. Later review of the ultrasound study showed a typical pattern. Medical Cost: $8,500, including psychiatrist. Emotional Cost: Impossible to estimate.

More examples will follow in upcoming posts.