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When Drug Trials Go Terribly Wrong – Lessons From a Bereaved Mother

June 9, 2009

…documents are soon to be released indicating that AstraZeneca, maker of Seroquel, was instructing its own drug reps to promote the drug as causing “less suicidal ideation than Risperdal or Zyprexa.” “Less suicide ideation” is not exactly a safety-standard that a reputable drug maker should be asking its staff to repeat.

Visit the blog on Psychology Today of Dr. Christopher Lane, author of Shyness: How Normal Behavior Became an Illness, to read this story about the courageous work of Mary Weiss in the wake of her son’s forced participation in a Seroquel study at the University of Minnesota, and his resulting suicide:


http://tinyurl.com/ldvsar

Please go to the story on Psychology Today and participate in the discussion. We have archived the story here.

By Christopher Lane, Ph.D. on June 8, 2009 – 10:13pm in Side Effects

Left to Right: Mary Weiss, her son Dan Markingson (27), and his girlfriend Tamar Bekmedzjian in August 2001 (photo courtesy of Mary Weiss).

I sometimes get mail from readers wanting to tell me about their experiences with American medicine and psychiatry. The information they share can present all kinds of predicaments, due to what is said and how it’s conveyed. For one thing, it’s shared outside any medical or psychological setting, and spoken to a stranger precisely because they’re not a friend.

Just as the person in question initiates contact, the information is volunteered for reasons that vary greatly. At such moments, just for a moment, I’m asked to lend an ear to worries, secrets, and often memories that are tied to great sadness. Entrusting someone with that information is a risk, but it makes you briefly its witness.

Mary Weiss, a mother in Minnesota, was one such person who wrote me last month. I’d been on the radio, talking about issues tied to my book. Ms. Weiss wrote an email afterwards, telling me about her son, Dan Markingson, who’d been diagnosed with schizophrenia, though she herself has serious doubts that the diagnosis was accurate.

Her son was encouraged to participate in a clinical trial at the University of Minnesota comparing Seroquel, Risperdal, and Zyprexa for schizophrenia, schizoaffective disorder, and schizophreniform disorder, a loosely defined diagnosis for people suffering from “mood disorders with psychotic features.” The trial was sponsored by AstraZeneca, maker of Seroquel, which put the researchers and university in an obvious conflict of interest. Dan was given 800 mg of the drug.

Over 70% of patients in the trial dropped out. But Dan was strongly dissuaded from doing so and remained in it for five months. He’d been given a directive warning that if he failed to continue in the trial, he would be put in a regional treatment center. His mother did not know about the directive until it was too late.

This is how Ms. Weiss’s message to me began, in words she wants me to share with PT readers:

“My son Dan died almost five years ago in a clinical study at the University of Minnesota, a study he lacked any diagnosis for, and a study that I tried unsuccessfully to get him out of for five months.”

Newspaper reports on Dan’s death are equally disturbing. The first of three that appeared last spring in the Twin Cities’ Pioneer Press began thus: “Dan Markingson had delusions. His mother feared that the worst would happen. Then it did.”

“Tragic,” a university official wrote in a “serious adverse event” memo to the U.S. Food and Drug Administration, the report continued, but suicide was “unfortunately not uncommon in this study population.”

Let me just repeat that line from the university’s memo: Suicide was “unfortunately not uncommon in this study population.” That alone should have raised numerous flags. Another serious concern: Seroquel comes with ample, well-publicized warnings that it should never be prescribed to seniors with dementia-related psychosis because of risk of death. Why, then, is it considered acceptable to test the drug on children, teens, and men like Dan, a practice that is still continuing unabated, including at the University of Minnesota, where the same antipsychotic was recently tested on those with public-speaking anxiety?

The Pioneer Press reports: Ms. Weiss “thought that her son, Dan, wasn’t getting better during his six months in the study. [She] sent five letters and made numerous calls to the researchers, complaining that her son … didn’t have the wherewithal to consent to the study and requesting that he be withdrawn.”

But the university “disregarded her letters and calls,” the report continues. “She later filed a lawsuit, accusing Markingson’s psychiatrist and the study’s director, Dr. Stephen Olson, of coercing him to sign up. The lawsuit claimed the university kept Markingson enrolled to preserve its research and to keep payments coming for his participation.

“Do we have to wait until he kills himself or someone else,” she asked three weeks before the suicide, “before anyone does anything?”

In a follow-up report, “Patient’s Suicide Raises Questions,” the Pioneer notes: “A judge ruled in February [last year] that as a state agency, the university and its IRB [Institutional Review Board] are immune from the lawsuit.” One of the questions raised by the newspaper, however, is not only that AstraZeneca sponsored a trial concerning its own product, but that drug companies as a whole have given “$88 million in gifts, grants and fees to Minnesota doctors and caregivers since 2002, according to state payment records, including $782,000 to the two University of Minnesota psychiatrists who oversaw Dan Markingson’s participation in a clinical drug trial.”

Such details might sound impossibly bleak—with the university and its wealthy donors closing ranks to prevent a full and open investigation into what went wrong. To add just one more detail, to convey the odds facing Ms. Weiss, in St. Petersburg, Florida, documents are soon to be released indicating that AstraZeneca, maker of Seroquel, was instructing its own drug reps to promote the drug as causing “less suicidal ideation than Risperdal or Zyprexa.” “Less suicide ideation” is not exactly a safety-standard that a reputable drug maker should be asking its staff to repeat.

But the rest of Ms. Weiss’s letter did contain some good news. Her struggle to get the university to admit responsibility for her son’s death, though turned down by one court, got the attention of lawmakers in St. Paul who wanted, with Mary, to make sure that participants in drugs trials in future could withdraw from them with less difficulty if, as Dan did, they began manifesting symptoms before the trial was scheduled to end.

“After four years’ effort,” Mary wrote me, “a bill in Minnesota has passed, effective August 1 this year, prohibiting anyone on a stay of civil commitment from entering a psychiatric clinical study.” Additional wording has strengthed the legislation, ensuring that the principal investigator in the study cannot also be the enrollee’s attending physician. “Next,” she continues, “I want to work to make people understand the danger of what the pharmaceutical companies are attempting to do—indeed are doing—to infiltrate our lives with drugs for whatever may ail us on a particular Tuesday morning.”

The new legislation is called “Dan’s Law,” in honor of Mary’s son, and though it currently contains a small loophole allowing doctors to petition the courts against the ruling, various state representatives as working hard to close that exception and make the legislation watertight.

I join countless colleagues, legislators, and state representatives in saluting Mary Weiss for her tireless advocacy for greater patient safety in drug trials. No one should be obliged to complete a clinical trial when they are manifesting acute side effects. The principal imperative in medicine must always be “Do no harm.”

It’s unconscionable that the doctors in charge of the clinical trial ignored this imperative and dissuaded Dan from withdrawing. The new law in Minnesota hopefully will make sure the same thing never happens again.

www.christopherlane.org

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3 Comments leave one →
  1. Mark permalink
    June 16, 2009 10:48 am

    When is enough, enough with the psychiatry dept at the university of minnesota. From charles “sarge” schulz on down they are nothing but money grabbing hawks.

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