As usual, I’m a little late catching up with some of the news.
Last week, Art Caplan emailed me a link to his latest column, describing a disturbing report issued by the Department of Health and Human Services. As usual, when writing on this topic, he is right on target in describing the problem:
A new report from the inspector general of the Department of Health and Human Services paints a very grim picture as to how well the FDA protects Americans who are subjects in human experimentation. The FDA is called on the carpet for not knowing how many experiments are actually being done in the United States. The report also faults the FDA for inadequate audits of research sites and a failure to ensure compliance with its orders when FDA inspectors find something amiss at a research site.
The problems discussed in the report are not new. They have been festering for years.
Caplan doesn’t give a clue as to just how many years this has been in the making, but I’ll add a little more info. At least some of this slide was well-documented during the Clinton administration, during which the FDA inexplicably expanded “nonconsenting” research at a time when it was clear that many researchers weren’t protecting research subjects (the link goes to a page with two articles – the quote is from the second article, written in 1998):
“According to investigative reports from a couple of years ago, the FDA’s own data indicate that about half the medical researchers they have monitored (after the fact) had significant problems in terms of documenting informed consent or giving enough information so that consent could be truly informed,” Drake adds. “It seems we are giving further powers to a group that has a shitty track record of obeying already existing rules.”
It’s obvious that was sliding during the Clinton years is sinking under the Bush administration, and that things have gone from very bad to almost worse than one can imagine.
Like I said, I’m late on this. The Medical Humanities Blog, Pat Bauer, and others wrote on this last week. Bauer’s blog entry was the one that really grabbed my attention, with this:
The New York Times account documents the case of a woman who tried to withdraw from a research study only to be imprisoned against her will and dosed with the experimental drug over her objections. Although federal authorities were notified, an FDA inspector did not arrive at the research facility for more than nine months and the official letter of warning from the FDA did not come until more than two years after the woman’s imprisonment.
Wow. No one else that I read mentioned that. I went to the NY Times article “Report Assails F.D.A. Oversight of Clinical Trials” to get the full account:
The case of Audine Graybill demonstrates the flaws in the system. According to the F.D.A., in the spring of 2005, she decided to try an experimental drug to treat mania associated with bipolar disorder. The consent form that she signed on May 29 stated that she could change her mind at any point in the study.
She checked into High Pointe Healthcare in Oklahoma City, a psychiatric center owned by a psychiatrist, Dr. David Linden. On June 3, Ms. Graybill changed her mind and asked to leave.
Dr. Linden refused to let her go.
On June 6, she was given the experimental medicine. Ms. Graybill’s lawyer, Anthony Sykes, obtained a writ of habeas corpus for her to appear in court and took the writ to the hospital, where the staff refused to honor it and said it would not give it to Dr. Linden, Mr. Sykes said.
Mr. Sykes tracked Dr. Linden to another office and had him served with the writ, Mr. Sykes said. Within hours, Dr. Linden’s lawyer called Mr. Sykes and said Ms. Graybill was free to go. Mr. Sykes took her home on June 7.
Ms. Graybill could not be reached.
More than nine months later, an F.D.A. inspector appeared at Dr. Linden’s research center and uncovered myriad other problems.
The agency sent its warning letter more than two years after Ms. Graybill’s experience.
Last November, the Oklahoma Board of Medical Licensure and Supervision suspended Dr. Linden’s license for three months because he had sex with two patients and gave them genital herpes infections, according to board records. Dr. Linden, who also owns a psychiatric center in Las Vegas, did not return repeated telephone messages.
Dr. Linden has conducted clinical trials for most major pharmaceutical companies and continues to do research, according to his Web site.
OK, I concede that the FDA has to increase its oversight and that it needs to investigate complaints quickly. If the complaints are valid, there should be actual consequences.
But what happened to Ms. Graybill isn’t just a “regulatory” matter. It seems to me that there should have been a criminal investigation – possibly for kidnapping (depending on the Oklahoma definition for that crime), assault (for the injection of experimental drug she’d refused) and possibly other charges.
After all, it doesn’t look like the Oklahoma Board dealt with these allegations. And the discipline he received for other misconduct was only a temporary suspension – in that one state. We can safely assume the Oklahoma suspension didn’t affect his practice in Las Vegas.
While we wait for Congress to adequately fund the FDA, for medical researchers to show uniformly ethical behavior, for the Bush administration to decide some regulations should be enforced, and some other things that might not happen any time soon…
Maybe when a doctor does something as was allegedly done to Ms. Graybill, we shouldn’t bother calling the government inspectors. Maybe it’s time to call the police.
The publicity accompanying a kidnapping charge against a researcher just might have a “chilling effect” on similar unethical and illegal behavior. Sometimes, a chilling effect can be a good thing. –Stephen Drake