Are You Faruk-in’ Kidding Me?

Sorry for my delay in jumping on the latest New York Times story (courtesy of Gardiner Harris and Janet Roberts) detailing how drug companies hire doctors to carry out clinical trials despite their questionable backgrounds.

Much discussion of this sordid tale has already occurred at such outlets as:

• Furious Seasons
• Health Care Renewal
• Psych Central
• Pharma Marketing Blog
• AHRP
• Pharmalot

Most of what I wanted to say has already been said by the above writers. However, I have a bit to add.

Quote of the Week: Hell, this might be quote of the year, really. In the out of touch with real people category, I submit, from the New York Times [emphases added]…

Dr. Ronald Hardrict, a psychiatrist from Minneapolis who pleaded guilty to Medicaid fraud. In 2004 and 2005, he collected more than $63,000 in marketing payments from seven drug makers. In an interview, Dr. Hardrict said it was “insulting” and “ridiculous” to suggest that income from drug markers might influence doctors’ prescribing habits. [and on to the quote of the week…]

“I bought the Mercedes because it has air bags, and I use Risperdal because it works,” Dr. Hardrict said, referring to an antipsychotic medicine for schizophrenia. Johnson & Johnson, the maker of Risperdal, paid Dr. Hardrict more than $30,000 in 2003 and 2004.

SNIP

Asked why other drug makers continue to hire him despite a fraud conviction, Dr. Hardrict responded with an email message stating only, “I will pray for you daily.”

I think I speak on behalf of my readers when I say that we’ll likewise be praying for Dr. Hardrict and his Mercedes.

Are You Faruk-in’ Kidding Me? Sometimes a person’s name makes for a catchy headline, so I thank Dr. Faruk Abuzzahab for that. I was reading through the Minnesota Board of Medical Practice’s lengthy document that detailed the alleged misdeeds which resulted in a suspension of Abuzzahab’s medical license. Very interesting document.

We all make mistakes. Occasionally we make large mistakes. That’s okay. But a pattern of making similar mistakes, errors that lead to significant anguish and, in some instances, may contribute to the death of people – that’s not okay. I’ll run a trio of quotes from the report…

In a number of cases (including but not limited to patients #35, #36, and #40, for example), Respondent [Abuzzahab] enrolled psychiatrically disturbed and vulnerable patients into investigational drug studies without ensuring that they met the eligibility criteria to be in the study and then kept them in the study after their conditions deteriorated.

Respondent's documentation regarding patient #36's participation in the sertindole study differed from the staff's documentation. While Respondent documented at more than one point that patient #36 was much improved and mildly ill, staff consistently noted her deterioration throughout the study. It was also documented that patient #36 made several references indicating that she did not want to take the medications. Respondent failed to document his rationale for continuing investigational medication under these circumstances.

The pattern that emerges from Respondent’s treatment of the approximately 46 patients at issue in the contested case proceedings is that he regularly fails to substantiate his diagnoses, monitor whether the combination of drugs is appropriate for the symptoms being treated and is having the desired effect, and evaluate whether the benefit outweighs the adverse effects noted in the chart. This fundamental failure shows a reckless, if not willful, disregard of the patients’ welfare, exposes the patients to an unnecessary risk of harm and contributes to their deterioration while under his care.

A few years back, here’s a couple slices of what Morris Goldman from the University of Chicago’s psychiatry department had to say about the drug trial research field and about Abuzzahab, whom he investigated:

There are ''people drawn into this field because they are interested in dollars,'' Goldman added. ''They are very profit-conscious. And that combination of a lot of money, plus the added ethical dilemma you face in human research, that is a bad combination. And there are particular risks with psychiatric patients, with the whole issue of informed consent. It can really go wrong.''

''He [Abuzzahab] would have the patient's diagnosis called one thing in the regular chart, and then the person would be put on a drug study and the person's diagnosis would be called something else to fit the criteria''

Journalist Robert Whitaker (in the Boston Globe) said the following about Abuzzahab, and the transcript from the Board of Medical Practice (pgs. 21-22) appears to back his reporting.

In another instance, the psychiatrist took a woman off clozapine, a newly approved drug that had led her to make a remarkable recovery, and enrolled her in a drug trial. The woman had previously spent 13 years as an inpatient at a psychiatric institution, but while on clozapine she had been able to go into the community and even hold a job. One day she approached Abuzzahab with questions about clozapine's side effects; he immediately stopped the drug that had helped her so much and put her into an olanzapine trial. She deteriorated until she found her way to another physician, who put her back on clozapine.

The Payout: Two disclaimers first: 1) I cannot verify the accuracy of the following information, though I have no reason to doubt its veracity. 2) I am not disclosing the source of the information, as I believe it could lead to untoward consequences in the wrong hands.

I found that Abuzzahab lives (or recently lived in) a house described in the following manner:

Built in 1931. The structure is a 2 1/2 story, 7569 square foot, eight bedroom, six bathroom, 17 room, single family dwelling, with a partially finished basement.

I found that a home on his street recently sold for about $2.7 million dollars. The other home appears to be significantly smaller than Abuzzahab’s pad – I’m no realtor, but it my relatively uninformed guess is that Abuzzahab is living large in a three to four million dollar crib. Not bad. Who says forging records and prescribing inappropriately does not have its rewards?

My Take: Granted, the NYT report on Abuzzahab paints a very negative picture, as does the Boston Globe article, as does the Minnesota Board of Medical Practice document. Certainly, all of the above selectively examined negative evidence, and did not have a chance to see the patients who had benefited under his care. That being said, there seems to be more than enough evidence to indicate that there is no way Abuzzahab should ever be involved in clinical research again, and it is a bit scary to me that he is practicing medicine, though perhaps he has reformed his ways.

He’s also listed as an instructor for the University of Minnesota as recently as 2005. I’m not sure if he’s still employed at the university, but it seems quite odd that they would select him as an instructor.

For all I know, Dr. Abuzzahab is the nicest guy in the world. I wish him no ill. We all make mistakes, but there are some missteps, especially when they happen repeatedly, that should disqualify people from teaching university students, conducting research on the latest drugs, and caring for patients.

Lilly, Organon, Roche, GlaxoSmithKline, Pfizer, Janssen, Abbot, Merck, Boehringer Ingelheim, Bristol-Myers Squibb – who is going to run your clinical trials?

University of Minnesota – who is going to teach your students?

Fairview Clinic, who is going to treat your patients?