Times writer exposes fraud in clinical trials
At least 70 pharmaceutical drugs are on the market after passing clinical trials based on fraudulent data provided by a California doctor, said Kurt Eichenwald, an investigative reporter for The New York Times.
Eichenwald, author of "Conspiracy of Fools: A True Story," about the Enron scandal, spoke Tuesday night at Williams College on "Clinical Trials in the Era of Corporate Medicine: Promise and Benefit, Betrayal and Fraud," focusing on how corporate interests influence clinical trials for new medicines.
He gave an as example a Southern California doctor who became the largest medical researcher with a private practice in the western United States, but ended up in jail after his fraudulent practices were revealed.
"After four or five years in the business, he and his wife lived in a mansion. They both drove Mercedes and they were building their dream home in the Caribbean," Eichenwald said.
The problem was, he said, the doctor had figured out how to lie and cheat and get the money he wanted. In one drug study, people with a particular protein level in their urine were needed. This doctor found one person with that level of protein in her urine and gave her $25 a bottle to be used to admit those who were not qualified into a study, he said.
"You had patients who were participating in asthma studies that excluded anyone who didn't have asthma and anyone who smoked," Eichenwald said. "(The doctor) admitted people without asthma as having asthma. He admitted people who smoked as not smoking. It was a very, very simple process. You just simply lied and hundreds of thousands and then billions of dollars came floating in."
When some of his practices were questioned by a monitor, the doctor complained to the drug company, which replaced her, Eichenwald said.
Finally, one of the doctor's employees exposed him and, once the fraud was revealed and he was sent to jail, the Federal Drug Administration subtracted his data, but did not repeat the trial, Eichenwald said.
In the area of clinical trials, "We are in the middle of a pharmaceutical renaissance. Make no mistake, this is a good thing. You are getting new levels of disease control from pharmaceuticals. The life expectancy of Americans is going up," he said.
However, this renaissance creates a new pressure: "Today, pharmaceuticals are not just a multibillion-dollar industry," Eichenwald said. "They are a multibillion-dollar industry that depends on speed. You need to be able to get a drug approved quickly because somebody else is testing the same thing. ... It's a race and that creates an enormous demand for something we didn't have as much demand for in the past — for clinical trial subjects, for us."
While 15 to 20 years ago, testing was done at academic institutions today the vast majority of research is not, Eichenwald said. Instead, many clinical trials are done at local doctors' offices, changing the nature of the doctor-patient relationship when people agree to become part of a study, he said.
"Medical research is not treatment," Eichenwald said. "... The purpose of treatment is someone comes to the doctor's office with a problem and the doctor does what he or she can to make that person well."
Proper experimentation, he pointed out, involves some people getting a placebo.
"Your doctor is no longer treating you. The reason why is, in research, the patient is not the issue. The patient is not what is on the front of the table. What is on the front of the table is the data establishing whether or not a proposed medical treatment works," Eichenwald said.
"To continue a pharmaceutical renaissance, you need to have clinical trials. But when clinical trials become a substitute for treatment, what is happening is we are undermining the doctor-patient relationship," he said.
"We are creating a circumstance where the patient's health is not necessarily the primary goal of the physician."
Doctors who act as medical researchers can be paid between $3,000 and $5,000 per patient. Nurses, too, receive bonus incentives for signing people up quickly, Eichenwald said.
"We are allowing financial incentives to drive our decisions and we are not recognizing that medical research is enormously valuable, but it is not treatment," he said.
"Clinical trials are serious. Clinical trials are important. Clinical trials are incredibly valuable, and if we, as a society have to begin to take that much more seriously than we have."