Friday, 21 September 2012

Studying Drugs in All the Wrong People

How the costly race to enroll subjects in psychiatric research trials is harming patients and compromising treatment


In Brief

Subject to Interpretation
  • Pharmaceutical companies offer financial incentives to researchers to fill drug studies quickly with large numbers of patients who may not be strictly suited to the trial.
  • These inappropriate study subjects skew the results or cause trials to fail, and promising drugs never reach the patients they could have helped.
  • The rising costs of these failed trials carry downstream to health care consumers and taxpayers.

One evening in the emergency room, I was asked to evaluate a patient requesting admission to the psychiatric unit. Gia was waiting for me, looking pale but fit. (All individuals identified only by their first name have been assigned pseudonyms, and their identifying details have been changed.) She had heard that the hospital was recruiting inpatients for a study of bipolar disorder and wanted to participate. She described herself as moody—upbeat for a few hours, then down, then happy again.

“How do you feel right now?” I asked.

“Okay,” she shrugged.

Psychiatric diagnosis is as much an art as a science, and it relies largely on a physician's observations and a patient's self-reports. Gia's calm, even speech, her pleasant demeanor and her relaxed manner were not in keeping with a bipolar diagnosis, nor were the symptoms and history she related. At the same time, all was not well—her lab work and vital signs revealed several abnormalities, including low blood pressure, anemia and troubling results on liver tests.

“Are there any medical conditions you forgot to mention?” I asked, puzzled. “Or medications?” I ran through an exhaustive list of symptoms—itchiness, weight loss, light-headedness. At last, when I asked about possible chemical exposures in her line of work, Gia produced a stack of business cards.

“Your employers?” I held seven or eight cards. The names included several nutritional and biomedical companies. “What do you do for them?”

“I try things. Drugs. Pills. Products.”

Gia took these drugs for money. Yes, she said, she had participated in psychiatric studies before. I expressed concern about her lab results and asked if she could recall more details about the pills she had taken. She said she was not sure how many different experimental agents might be in her system at that moment. I shuffled and reshuffled the cards in my hand.

“So ...” Gia said, breaking the silence. “Is there room in the study?”

Researchers involved in psychiatric drug development know patients like Gia well. They ask to join studies in which they may not really belong, motivated by the monetary compensation. The question is not why such individuals wish to take part but why anyone would want to enroll them. Testing a drug for bipolar disorder—or any other ailment—on people who feign the condition will skew the results. And yet these subjects are enrolled in trials, over and over again. The reasons why reveal a troubled system, one in which study sponsors reward researchers for recruiting as many subjects as they can. As a result, studies can produce suspect findings, which then sway doctors' treatment decisions for countless others.

Some of these trials fail altogether, and it may well be because the wrong patients are enrolled. The corresponding increase in the cost of drug development—currently on the order of $1.8 billion to bring a single new drug to market—carries downstream to all of us, as both health care consumers and taxpayers. The problem is particularly acute in psychiatry because the subjective nature of its ailments makes it comparatively easier to enroll the wrong patients. As this country undertakes a historic, and expensive, overhaul of our national health care system, we cannot afford to miss this piece of the puzzle.

When Quantity Trumps Quality
Ten years ago, when I first entered medical school, the pharmaceutical industry was barely on my radar. I would see residents carrying briefcases emblazoned with various companies' logos, perhaps stopping in at sponsored luncheons to grab a tuna wrap on their way back to the wards. That was about it. The medical research in which I participated as a student was, to my knowledge, sponsored entirely by the government. Only years later did I realize how anomalous such publicly funded research was fast becoming.

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