Sex, Psychiatric Drugs, and the Honor System

I had briefly alluded to Dr. David Linden in an earlier post. You may recall that he is the psychiatrist who had his license suspended by the State of Oklahoma because, through sexual contact, he gave genital herpes to two patients. I had never known why Oklahoma was called the Sooner State, but now it makes sense. If you have sex with, and give herpes to your patients, you get your license back sooner than anyone would reasonably expect. To be specific, his license was suspended for a grand total of three months for such misconduct. Can you say slap on the wrist with a wet noodle?

So who is this guy? Let's find out.

License. A link to his Oklahoma physician profile can be seen here. Remember, two cases of herpes transmitted to patients = three months suspension of Oklahoma medical license. I find it more than a bit confusing that his Nevada license is still active. It would appear that in the state which houses Sin City, one can have all the sex with patients that one wants and not be subject to disciplinary action. So give herpes to two patients through sex, and the consequences are having a license suspended for three months in one state and no consequences in another state. Very interesting. Perhaps his transgressions occurred in Oklahoma, so Nevada figures it is out of their jurisdiction. But, if a doctor has sex with patients in one state, I'm going to go out on a limb here and say that his license should be suspended (or, maybe, just maybe, permanently rescinded) in all states.

Imprisonment of Study Participants. That's what the FDA found in their investigation of Dr. Linden. One woman wished to participate in a study in Linden's inpatient facility. She agreed to participate in a study and then changed her mind. She was not allowed to discontinue the study for four days, and only after the involvement of an attorney. What part of "you can discontinue the study at any time" did Linden fail to comprehend?

Patients Without Consent. Two patients did not sign informed consent forms to participate in studies. This is a gigantic no-no. Participants absolutely must provide consent to participate in studies, particularly when they involve taking medications. On six additional occasions, participants signed the incorrect consent form.

Unlicensed Hospital Stays. In one study, patients were placed in an unlicensed hospital for at least two weeks. The study protocol called for patients to be placed in a licensed hospital. Oops.

Drug Dosing. Patients were given incorrect doses of study medication on multiple occasions in one study. I'll quote the FDA report regarding drug dosing in another study:

The amount of study drugs dispensed to, and returned by, subjects 002, 005, 008, 015, and 020 cannot be determined.

Adverse Events? What Adverse Events? Two participants who were placed under emergency inpatient detention during their participation in studies -- their extreme mental instability was not reported as a serious adverse event. Seem to me like it would be rather important to report all serious adverse events that occur in a study. Unless, of course, one was either sloppy or wanted to bury negative data.

And there is more, believe it or not. The FDA investigation only examined two trials. All of the above problems and more based on two studies. Impressive. And then he collects data which is the foundation of the "science" that supports various medications.

Who Would Hire This Guy? Well, let's see. According to his research webpage, he has done clinical trial research for the following:

• AstraZeneca
• Bristol-Myers Squibb
• Boehringer Ingelheim
• Eli Lilly
• GlaxoSmithKline
• Janssen
• Johnson & Johnson
• Novartis
• McNeil
• Pfizer
• Shire

And, to quote his site: "The following Contract Research Organizations have greatly contributed to our success"

• I 3 Research
• INC Research
• Parexel
• PPD Development
• Quintiles
• Rho Inc.

Want to sign up for one of his trials? It appears that his research organization is recruiting patients with the following conditions:

• Alzheimer's
• Dementia
• Depression
• Schizophrenia
• Bipolar Disorder
• Insomnia

On the Stump. Given his impeccable research and ethical credentials, it is no wonder that Dr. Linden...

...is also recognized as a leader in his community and he is a member of several Speakers Bureaus including: Wyeth Pharmaceuticals, Pfizer Pharmaceuticals, Bristol Myers Squibb and others.

Time For Bad Jokes. I can't help myself. Here are a couple of quotes from his site.

Our P.I. is Actively Involved in Trials
David E. Linden, M.D., our Principal Investigator, is actively involved in the research we conduct. As a result, you directly benefit from his years of experience and expertise.

Yes, he has a very hand-on approach. Wink-wink. Also feel free to insert your own punchline. One more...

Dr. Linden has an extensive and prestigious portfolio in Clinical Psychiatry.

Again, I'll leave the punchline to you. It would appear that drug companies have rather lax standards regarding their investigators, would it not? It would seem that imprisoning your patients, having sex with them, playing all sorts of sloppy with data, and other misdeeds would disqualify a person from engaging in clinical trial research. I understand that there will be occasional data errors in research; one can never rule out human error and I accept that. But this is well past slight mistakes due to occasionally poor oversight. And is this what we would like our "science" to based on?

I've written about a similar situation (minus the sex/herpes part) in an earlier post. After reading this post and my prior post, as well as the links contained in both posts, does it not make one wonder the extent to which psychiatric drug research is based on sloppy and/or fraudulent data? I'm not throwing out a number here. I really have no idea. Perhaps these are rare occurrences. But given that FDA oversight of research is close to nonexistent, much of what happens in research is essentially done on the honor system. Unfortunately, it appears that there is enough dishonor in the current honor system to strongly suggest that we need a lot more oversight.