Possible Conflicts Of Interest On FDA Advisory Committee For Consumer, Patient Reps

Some of you are aware that on Saturday the Philadelphia Inquirer had an excellent article which established that the chair of the FDA's Psychopharmacologic Drugs Advisory Committee, Florida child psychiatrist Jorge Armenteros, who was set to chair this week's committee hearing on Seroquel's potential aproval for depression and anxiety was forced to recuse himself. He's gotten funding from AstraZeneca in the past to talk to doctors about using Seroquel and with an AZ drug coming before the committee, he either opted out of the hearing or someone at the FDA forced him out. The FDA won't tell me which it was. (Soulful Sepulcher has also written about Armenteros.)

Four other permanent voting members of the committee are not listed as participating in this week's hearing, according to the paper, which is downright odd.

"FDA spokeswoman Sandy Walsh said that temporary members sometimes replace standing committee members but that the agency does not say why such substitutions occur. Armenteros remains the chair of the standing committee until his term expires in June, she said."

Well, with a hearing scheduled for June on Seroquel's approval for use in kids, I'd say Armenteros' days as committee chair are over.

Meanwhile the agency has had to do a bunch of scrambling to round up temporary committee members to add to the two (yes, only two) standing committee members who'll be hearing testimony this week. After doing some poking around, I'd have to say that both the consumer member of the committee and the temporary patient member of the committee have potential conflicts of their own that make me question their ability to be thorough and impartial and actually represent consumers and patients.

The recently-added psychiatric researcher members of the committee appear to have mostly received monies from pharma companies, but none from AZ as near as I can tell.

The consumer member is Gail Griffith. She's a Washington, D.C. based writer, who authored the book Will's Choice about her then-teen son's suicide attempt. In a disclosure made to the FDA, she reveals that she owns stock in pharmaceutical companies amounting to less than $25,000. Griffith has also made numerous appearances at various NAMI state level conventions and meetings, some as far away as New Mexico. I hope she has revealed to the FDA whether she received any honoraria and travel reimbursement for these appearances, as even state and local level NAMI affiliates receive a portion of their funding from pharmaceutical companies--especially for conferences--and it's possible that some of that could have somehow trickled through to Griffith. It's of course well-known that NAMI National receives about half of its annual $12 million budget from pharma companies.

She's also presented to a Mental Health America affiliate and to the American Psychiatric Nurse's Association. So I hope the FDA has pressed her on this matter for any potential pharma dough that may have found its way to her, directly of indirectly.

In addition, Griffith was first appointed to the committee in 2004 as patient member and voted in favor of the black box warning on suicidality on anti-depressants in 2004 (good for her). She again had to wrestle with a suicidality warning on anti-depressants, this time to potentially expand the warning to 18 to 24 year olds in 2006. She voted against the expanded warning. Here's how she explains this on her website:

"Gail is quoted in this Newsweek article which suggests that the black box warning on antidepressants for teens and young adults may have had an adverse effect on prescribing practices. Griffith says, 'If I had known how much the label would rattle parents, I wouldn't have voted for it [the black box warning].' In December 2006, the FDA's psychopharmacological committee voted 6 to 2 to extend the black box labelling to young persons up to twenty-four years of age. Griffith voted against extending the label to include this larger constituency, (sic) siting the extraordinary vulnerability of this population and the disastrous consequences of failing to treat depression."

She was later made a consumer member of the committee in 2007. Thankfully, the committee voted to expand the warning, but did not expand it beyond 24 year olds to other adults.

While Griffith is welcome to her private opinions, I am troubled that a voting member of an FDA advisory committee would worry about rattling parents with a black box warning. She should be vastly more interested in dealing with the facts as they are before her and vote accordingly.

This leads me to question her ability to deal appropriately with the alarming metabolic injury data cropping up around Seroquel's use in just about every condition under the sun, including in depression and anxiety. How could she effectively sort through potentially recommending approval or rejection of the drug or how could she evaluate possible recommendations for strong warnings on the drug if she's worried about such information, truthful as it may be, rattling patients?

I have my doubts.

The very purpose of a black box warning is to properly warn health care providers and patients of the very real potential of life threatening risks associated with use of the black-boxed drug. If that rattles anyone, then so be it.

Next, let's turn to Margy Lawrence. She's listed as being a temporary patient member of the committee. In 2007, she's listed on the NAMI of Montgomery County (MD) 990 as being the vice-president of the board (the form actually cover the period until June 30, 2008) and is currently listed on the organization's website as being the contact person for those wishing to volunteer for the group. She is not listed on either the 2007 990 or on the group's website as being paid any monies. But there's still something that made my eyebrows arch.

According the NAMI of Montgomery County's website, 20 percent of the group's revenue came from the following:

"Montgomery County Government, the Maryland Home and Community Care Foundation, the United Way Foundation, the Holland Foundation, the Gannett Corporation, Vanguard, the Montgomery County Community Foundation and Astra-Zeneca supported Family to Family, Latino Outreach, Child & Adolescent and general programs and provided funds for capital expenses."

While it's not clear how much AZ money was given to the group, it appears that the committee's patient representative for the upcoming hearing on AstraZeneca's drug Seroquel is someone who has potentially participated in AZ-sponsored activities or may have, as volunteer coordinator, helped put together activities and outreach that were sponsored in part by AZ.

Then, of course, there's what could be the biggest conflict of all for both Griffith and Lawrence. Both are deeply embedded in the NAMI worldview, which in its extreme forms amounts to little more than the complete acceptance of the line that all mental illnesses must be medicated for life and that all medications are always good.

I hope that the FDA queries the pair about their potential conflicts.

Posted by Philip Dawdy at April 6, 2009 12:03 AM
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