Tuesday, June 17, 2008

Chantix and Veteran's Affairs: Who Needs Consent? We Got 'Em, Let's Dose 'Em

It looks like a Department of Veteran's Affairs drug test involving Chantix has been handled badly. And, it's getting into the news in a predictable way. Here's a sample:

Medical Experiment at Department of Veteran's Affairs, in the News

  • "VA testing drugs on war veterans"
    The Washington Times (June 17, 2008)
    • "The government is testing drugs with severe side effects like psychosis and suicidal behavior on hundreds of military veterans, using small cash payments to attract patients into medical experiments that often target distressed soldiers returning from Iraq and Afghanistan, a Washington Times/ABC News investigation has found.
    • "In one such experiment involving the controversial anti-smoking drug Chantix, the Department of Veterans Affairs (VA) took three months to alert its patients about severe mental side effects. The warning did not arrive until after one of the veterans taking the drug had suffered a psychotic episode that ended in a near lethal confrontation with police.
    • "James Elliott, a decorated Army sharpshooter who suffers from post-traumatic stress disorder (PTSD) after serving 15 months in Iraq, was confused and psychotic when he was Tasered by police in February as he reached for a concealed handgun when officers responded to a 911 call at his Maryland home...."
  • " 'Wash Times': V.A. Using Iraq Vets as Guinea Pigs in Drug Tests "
    Editor & Publisher (June 17, 2008).
    • "NEW YORK As if the "soldier suicide" problem wasn't bad enough already, word has just emerged from ABC News and The Washington Times that our government is testing drugs with severe side effects, including promoting suicidal behavior, on hundreds of vets.
    • "In one case, the V.A. took three months to alert the veterans to the severe mental effects caused by one of the drugs, the controversial Chantix, used to halt smoking.
    • "They are even using cash payments to attract patients into medical experiments "that often target distressed soldiers returning from Iraq and Afghanistan," the newspaper puts it today....
  • " 'Disposable Heroes': Veterans Used To Test Suicide-Linked Drugs"
    ABC News (June 17, 2008)
    • "Mentally distressed veterans from Iraq and Afghanistan are being recruited for government tests on pharmaceutical drugs linked to suicide and other violent side effects, an investigation by ABC News and The Washington Times has found.
    • "The report will air on Good Morning America and will also appear in The Washington Times on Tuesday.
    • "In one of the human experiments, involving the anti-smoking drug Chantix, Veterans Affairs doctors waited more than three months before warning veterans about the possible serious side effects, including suicide and neuropsychiatric behavior...."
    • (A video clip is captioned "Mentally distressed veterans are recruited for questionable drug trial.")
Just keeps getting better, doesn't it?

From what I've read, this is a scandal, and an avoidable one. Ever since Chancellor Hitler and his massive reforms put medical experimentation on human beings into the spotlight, there's been little excuse for doctors to regard their patients as expendable experimental subjects.

A Lesson from Nürnberg: Get Informed Consent Before Experimenting on People

The so-called Nürnberg Code was supposed to give physicians guidelines about how to use people as guinea pigs. It didn't work quite as well as might have been hoped.

After the code was set up, America saw a number of more-or-less well-publicized lapses:
  • Tuskegee syphilis experiment (1932-1972)
    Black men in in Macon County, Alabama, who had syphilis weren't treated
  • Harold Blauer (1952)
    Mr. Blauer went to the New York State Psychiatric Institute for treatment of depression, was dosed with mescaline derivatives supplied by the U.S. Army Chemical Corps: then he killed himself
  • High oxygen to premature infants (1953)
    Premature babies were exposed to high levels of oxygen: the doctor knew that it would probably cause blindness, and noticed their eyes swelling, but kept up the treatment anyway
  • Injections of cancer cells (1963)
    Doctors wanted to know if cancer cells would thrive as well in patients who were debilitated by something other than cancer, as they did in debilitated cancer patients, so they injected cancer cells into patients who didn't have cancer - without telling them.
    • Ironically, this non-consensual research was done at the Jewish Chronic Disease Hospital. And: "Two years later, the American Cancer Society elected the principal investigator to be their Vice-President."
  • Hepatitis in retarded children (1964+)
    The Willowbrook State Hospital in New York injected severely retarded children with hepatitis virus: as 'a vaccine against hepatitis.' True enough, survivors of the disease had an immunity.
  • Cincinnati radiation experiments (1960-72)
    Blacks, again, and this time exposed to high radiation. For the U.S. military. Without their consent.
    Source: "Nonconsensual Medical Experiments on Human Beings" (copyright 1997 by Ronald B. Standler)

What's Going on Here?

Although half of the cases that Mr. Standler mentioned involved the American military, half didn't. I don't see these excesses of experimental enthusiasm from the fifties and sixties - or the current scandal at the VA - so much as a military problem, as a medical one.

People as Lab Animals: a Personal View

I will admit that I have a personal stake in the matter of medical experimentation. Please indulge me, with this account my own experience: it does tie in with this post's topic.

I was born in 1951. Shortly after that, the doctor my parents had trusted rotated my legs. It's a quite routine procedure, still used, to determine if there are any issues with the hip joints.

As soon as my legs flopped over, I screamed. The doctor made some remark to the effect of "that seemed to hurt."

Some time later I was diagnosed with congenital hip dysplasia. Non-surgical treatments were tried, but didn't work. Finally, after a best-try reconstruction of my left hip, it was obvious that I'd going to be at least semi-crippled for life.

My father was a librarian at a local college at the time. He was in the habit of taking a book or periodical at random from the shelves, to read during his shifts at the reference desk.

One day, he noted an interesting article in a medical journal. The title was something like "Consequences of Delayed Application of Treatment in Cases of Congenital Hip Dysplasia." The article, written by our family doctor, went on to describe how he had run across an infant with a bad case of congenital hip dysplasia.

What a lucky break! For the doctor.

'The top of my head blew off' - that's how my father, decades later, described his reaction to the article. Direct and passionate Irishman that he is, he wanted to go straight to the doctor for a frank and open discussion of the matter.

My Norwegian mother told him, 'no.' She went to the doctor's office, and discussed the matter with him. My mother is dead now, so we'll never know what she said.

Shortly thereafter, the doctor left his practice, on 'personal leave,' for an indefinite period.

In a way, it might have been more humane to have let my father unscrew his head.

Doctors: 'Medical Ethics' Shouldn't be an Oxymoron

Unhappily, using people as experimental subjects without getting their consent isn't the only problem we've had with doctors in my lifetime. Psychosurgery - slicing and dicing someone's brain to 'cure' moodiness, or some other inconvenient trait - was a sort of cure-all for a while.

I can remember when lobotomy was going out of fashion. We haven't heard about this charming practice for a while, but I see that it's coming back. At the risk of getting too far off-topic, I'll list a few lobotomy links, and move on:
  • psychosurgery.org
    "Remembering the Tragedy of Lobotomy"
  • "Portrayal of Lobotomy in the Popular Press: 1935-1960"
    "This study analyzed the content of popular press articles on lobotomy between the years 1935 and 1960...."
  • "Lobotomy's back - controversial procedure is making a comeback"
    "In 1949 lobotomy was hailed as a medical miracle.
    "But images of zombielike patients and surgeons with ice picks soon put an end to the practice.
    "Now, however, the practitioners have refined their tools."
  • And, last but not least, there's Dr. Walter "Icepick" Jackson Freeman II, who scrambled Rosemary Kennedy's brain, popularized the 'icepick lobotomy,' and did the same for about 2,500 other people in his energetic career.
    His contributions to society and medicine are covered online in
    • "The Lobotomist"
      PBS, viewable online
    • "The Lobotomist"
      By Jack El-Hai, an authoritative biography
      Chapter one available online, Mr. El-Hai hopes you'll buy the book
The point of that side-trip into slice-and-dice psychiatry is that doctors aren't necessarily right. That may seem obvious now, but back when Dr. Kildare (1961-1966), Ben Casey (1961-1966), and Marcus Welby, M.D. (1969-1976) were top-rated entertainment, many people really believed that doctors were somehow special. The problem was that some doctors seem to see themselves as a breed apart, higher beings who are beyond good and evil1.

When people who are unencumbered by conventional morality, and believe that their quest for knowledge justifies breaking the rules, have the sort of power that physicians have, we've got trouble.

The current medical mess at the VA doesn't reflect too well on a bureaucracy-bound American military, but I think that the problem here isn't the military-industrial complex: it's another case of doctors who can't be bothered with rules.

More, at

1(There's a pretty good summary of Nietzsche's book at sparknotes.com.

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