One Flew OUT of the Cuckoo’s Nest or, A Human Lab Rat Takes on The N.I.H.’s “Clinical Trial Culture”
Ruminant With A View
by Elizabeth Boleman-Herring
“First, do no harm.” —attrib. to Hippocrates
Note: Early in March, the author entered, and exited post haste, an N.I.H. clinical trial considering two drugs in the battle against depression (as well as, in her own case, recalcitrant post-operative back pain): one of them ketamine (an anesthetic gaining new, 21st-century attention as the “club drug” “Special K”). For further information on “my” ketamine study, see: http://www.nimh.nih.gov/science-news/2007/faster-acting-antidepressants-closer-to-becoming-a-reality.shtml , http://www.psychweekly.com/aspx/article/ArticleDetail.aspx?articleid=463, http://www.technologyreview.com/Biotech/19156/?a=f, and http://intramural.nimh.nih.gov/research/pi/pi_zarate_c.html).
TEANECK New Jersey—(Weekly Hubris)—4/4/11—Righteous indignation, aka outrage, is a garment best worn by groups. Thousands of outraged Wisconsin citizens have greater visibility than a single angry soul in a Cheese Hat.
Occasionally, however, there seems to be only one whistleblower on the scene able and willing to raise the alarm.
And that one whistleblower may not be a disinterested investigative journalist either but, rather, a “participant in the story.”
I am that whistleblower. This is my story.
You might imagine that the so-called mentally ill in my homeland do about as well as the physically ill, here, but you would be wrong. Warehoused, then released, en masse, into the mean streets in the decades of my young adulthood, the depressed, the bi-polar, and the clearly psychotic, plus those with two-digit or low-three-digit IQs, were set adrift, largely on their own recognizance, or into the care of good, bad and worse group-homes; “maintained,” as it were, on psychotropic medications. Right, like that was going to work.
“Therapy” went from the 50-minute-hour of the 1950s to the 10-minute drug consult of the 1980s. Only the worried-well-and-well-heeled would now receive the benefits of good talk therapy. Everyone else? Good-bye and good luck!
For 53 of my 59 years, I have lived with depression (see my last two columns: https://weeklyhubris.com/2011/03/14/my-indigo-twin-living-with-depression/; https://weeklyhubris.com/2011/03/21/walking-the-n-i-h-labyrinth/) and, the only child of a lay analyst/therapist, I have received the best care America (and Greece) have had to offer. I was one of the lucky ones.
When the SSRIs (Prozac and its clones) came onto the scene in the 1990s, I received some benefit from them, but was always unwilling to take the drugs in what is considered therapeutic dosages, due to their truly terrible side effects.
One side effect—and I pick it at random—is bruxism, or night-time teeth-grinding. I bruxed so mightily that, despite wearing a night guard designed to protect my teeth, I ground all my lower teeth out of my jaw in my 40s and early 50s. Some $25,000. worth of dental work, not covered by insurance (or by the pharmaceutical companies producing Prozac, Paxil and Celexa, etc., who list bruxism way, way down their lists of possible side effects) was required to enable me to go on chewing my food.
Spoiler Alert: the big pharmaceutical companies, and the doctors who shill for them, are not our friends, Nation.
Had I read up, sufficiently, on Dr. Carlos Zarate (http://intramural.nimh.nih.gov/research/pi/pi_zarate_c.html), into whose N.I.H. clinical trial I embarked last month, I would have found that, in addition to conducting clinical trials on ketamine, he is also applying for a patent on the use of this commonplace drug for the purpose of treating depression. (John Cloud, in a Time Magazine article dated 2 August 2010, states: “Zarate and his colleague Dr. Husseini Manji of Johnson & Johnson have submitted a patent application on behalf of the government for the use of ketamine in treating depression.”)
That is an “in addition” that raises the hair on the back of my neck.
If you are testing a drug on depressed clinical-trial-participants, read “human lab rats,” I personally believe you should not also be putting yourself in place to benefit monetarily from the results of your research.
Ketamine works on depression, and on recalcitrant post-operative spinal pain—the two conditions that afflict me. In my humble opinion, that ketamine may someday be named “Zaramanji,” or somesuch, in this country is indicative of at least a possible “conflict of interest.”
Ketamine’s been around for a long time, for on-label use as a pediatric and veterinary anesthetic. If, in his study, Dr. Zarate beats everyone to the punch in “proving” ketamine’s benefit for depressives, he may well get his patent. But to patent ketamine is morally equivalent, in my little book, to “patenting” acetaminophin or aspirin. Ketamine should be made available, and cheaply, to depressed patients and those suffering debilitating pain, w/o first enriching a pharmaceutical company riding along on the bent backs of . . . people such as I, a premium attached to its currently off-label use.
Are you following me?
There’s a thin, thin line, between those who would experiment upon those who cannot really supply their “Informed Consent”—and I number all the long-depressed in this group—and members of my species who treat their fellow beings as less than human.
I believe, with all my heart, that the taxpayer-funded N.I.H. is crossing this line today. I was given no evidence, when I was on Ward CRC-&SE North at the N.I.H. in Bethesda, that the N.I.H. cared a whit for the psychological welfare of its ketamine-study subjects. The sole stated concerns were to keep everyone as comfortable as possible for the duration of the trial. (My Consent Form baldly states: “There is no direct benefit to you from participating in this research study. However, we hope to learn more about mood and anxiety disorders and you will find out if you are eligible for other NIMH research studies.” Good God, do some people spend their entire lives on these wards? Un-paid, untreated, participating in study after study?)
All psychiatric staff made it abundantly clear to me that “therapy” was off the table on Ward 7.*
Therapy, in fact, would militate against the clinicians’ getting the best results. What they really need is depressed, consistently depressed, subjects. And then, over the course of a long, long stay—one woman had been on and off that ward for a full year’s time—in an excruciatingly long double-blind study, N.I.H. vouchsafes each subject, each human lab rat, a mere “taste” of ketamine.
But the woman mentioned above, and all the others on that ward, have been served so badly by American Medicine, and have become so desperate after long, long years of no remission of symptoms, that they are willing to try anything, trust anyone, lock themselves up anywhere, to find relief, remission, respite, even if it lasts mere days. They told me so.
So many people experience the lifting of symptoms immediately, and for days or weeks afterward taking ketamine, that they actually experience, as well, Hope, for the first time in their lives.
But ketamine is difficult to come by, infused on a regular, therapeutic basis, in America. It’s not impossible to get it, but it’s difficult. Other countries are another story altogether. (I do realize that Dr. Zarate is not responsible for all the evils that befall us vis-à-vis this drug, and its availability. His sins I narrowly define, but I hope I have here defined them.)
I was not deemed a good fit for your trial.
You’re damned straight I wasn’t.
I came onto that ward expecting humanity, and humans behaving ethically, and (again, in my opinion) I found a Cuckoo’s Nest of manipulation, subtle coercion and a clinical culture that would make Hippocrates hurl.
I saw the tools of psychiatry being perverted by the demands of research, the exigencies of inhumane (by definition, from the git-go) tests.
I “perceived” that Dr. Zarate did not like me. Many psychiatrists do not. I get right up in their faces and tell them that medicine is full of B-students, and that the DSM (http://en.wikipedia.org/wiki/Diagnostic_and_Statistical_Manual_of_Mental_Disorders) changes every few years, its rock-solid “definitions” of mental disorders sliding around to fit the changing climate of the day like cheap clothes on racks in NYC’s garment district. (At one point, not so many years ago, the DSM listed “homosexuality” as a mental disorder, just to give you an idea of the manual’s, shall we say, mutability.)
For our one lengthy interview, I made it a point to show up, not as a lamb to the slaughter but, rather, with a clipboard and with photocopied questions for Dr. Zarate, and the other clinicians in attendance. When advised that, man, woman and boy of my many former therapists/clinicians (none of whom he had consulted; none of whose notes on me he had read) had been wrong about my diagnosis over the decades, but that he, Dr. Zarate, had concluded I was Bi-Polar, and would thus be asked to take Lithium for the duration of his clinical trial, I told him that I would prefer to ingest arsenic, thank you.
Our little mano-a-mano went on for some 30 to 45 minutes (he’d said he’d give me “a few minutes” only), I believe so long because N.I.H. Alpha Researchers are rarely taken on in public, in their own “surgeries,” so to speak, by research subjects, and, so, he wanted to establish dominance—give me a good thrashing—in front of attending staff before dismissing me. But, hey, I could be projecting.
I say with some small pride that it did not go precisely as foreseen.
I was never a B-student.
My profound regret is that there are, tonight, some eight to ten other “subjects” still on Ward 7, some of them needlessly taking Lithium and Depakote, so-called mood-stabilizing drugs, which have deleterious and well-documented side effects (http://www.drugs.com/sfx/lithium-side-effects.html, http://www.drugs.com/sfx/depakote-side-effects.html).
None of these individuals, while there—and most will be there, on and off, for many, many months—has access to therapy, to truly human interaction with staff, to anything like the beneficence of real compassion, real interaction. They are watched closely by a phalanx of nurses who have, themselves, seemingly drunk the Kool-aid of N.I.H. Drug Trial Culture, and the only hope they have of remission while on Ward 7 is via the mental and emotional resources they are packing when they first walk in, and the metal door clicks locked behind them.
I was in Bethesda eight days. I “made use” of the N.I.H Labyrinth, the library, the chaplain, a day-trip to a D.C. museum, and cultivated the friendship of my fellow inmates. But, given another week or so in that poisonous waste and I believe I would have done a header off a balcony. Gladly.
And I, Gentle Reader, am a high-functioning depressive!
At one point in our battle of wits (for that’s how it appeared to me), Dr. Zarate asked me how depression had disfigured my life (my choice of words; his meaning). I said that it had cramped my style mightily; that if I were not working, at any given time, on a book or significant project, I felt I was not functioning at full capacity, and depression had hamstrung me often and badly.
Not having read my chart, knowing zip about me, he asked, with undisguised sarcasm, “Have you ever written a book?”
I paused a beat, counting. “Twelve,” I replied.
There was a gentle murmur (levity?) from the nurses and other clinicians on the right-hand, non-Zarate side of the enormous conference table . . . which self-snuffed itself immediately.
Before I left, I had my husband mail down to me from New Jersey The Complete Works of William Shakespeare. I had just about convinced my cohorts that we should do a table-reading of one of the plays, perhaps “Hamlet,” while I was there. I thought it would be a hoot, something along the lines of “The Persecution and Assassination of Jean-Paul Marat as Performed by the Inmates of the Asylum of Charenton Under the Direction of the Marquis de Sade.”
I regret that they and I will not perform the Danish play together.
But I pray they thrive, one and all, and get the hell out of that vicious playpen-of-doom soon, sooner, soonest. They deserve better. We all do.
So . . . for the nonce, alas, call me Ishmael, Dr. Ahab. For I alone have escaped to tell this tale.
*Just one specific example of my needlessly inhumane treatment on Ward 7 involved the administering to me of a standardized psychological test known as the S.K.I.D. In my own case, “talking” this test, which was administered by a “non-Native-Speaker,” an Iranian psychologist unable, fully, to understand my nuances responses (and I am nothing if not nuanced), took well over two hours, during which time the woman, stone-faced, urged me to recount and describe for her every trough, every trauma, experienced over the course of my long, piebald “career” with depression. (“And just how did being molested, repeatedly, as a 13-year-old affect you?”) At the end of the test, when I felt I’d been opened up alive, sans anesthetic, for surgery, and then not sutured up again (which any “therapist” would have seen to), let alone “ministered to,” I was set free to walk back to my room alone. When I later expressed my anger and disbelief at the way in which the test was administered, I was told by both the physician assigned to me and my primary nurse that even walking patients back to their rooms after such a “medical assault” (my words) is not “something they do.” In other words, they cannot even display the humanity required briefly to empathize with a test subject because they feel that that display of empathy would constitute another, positive variable in the clinical-trial-mix (my interpretation). I was gob-smacked at this admission on their parts, Dear Reader.
PS On 3.3.11, I submitted, in writing, a respectfully expressed list of queries and comments to Dr. Carlos Zarate. He did not acknowledge receipt of my written document, respond to my queries (some of which were urgent/required attention while I was still in-house), nor act upon any of my recommendations. I count this among his most serious derelictions of duty towards me as a patient and as a human being.
Dear Elizabeth, The 70th Anniversary of the famous BATTLE OF CRETE…will be bringing thousands to the memorials and celebrations to the Island of Crete…..are you planning to take a group (I HOPE!)…May 17th is fast approaching…I am still trying to make contact with any survivors, next of kin, of the evacuation ship…HMS PHOEBE…left Sphakia, Crete on May 31st..and arrived in Alexandria, Egypt, on June lst. 1941….Love, Barbara
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Great article!!! I looked into participating in the NIMH study in Maryland and decided against it (because I couldn’t/wouldn’t get off all my then medicine and) because of humatarian concerns that (after reading your article) I find out were quite legitimate… Unfortunately, I have very severe, very treatment resistant depression and would love to be in e-mail contact with any of the people (currently or previously) participating in the study… I am not looking to criticize the study with patients currently residing at the facility; I would just like to communicate with individuals who can relate to the level of severity, I experience, regarding this illness… My email address is firstname.lastname@example.org
Erif, I will send you an e-mail re all this, and thank you for writing in. I’ll bcc a study participant, and see if he feels comfortable contacting you, as well. More soon, eb-h