A Warning Letter Story

Normally here at Eye on FDA, warning and untitled letters are reviewed quarterly.  Sometimes, however, one stands out as somewhat extraordinary.  So it happens with a warning letter DDMAC issued last week regarding a DVD.

The DVD features an interview with Magic Johnson about his HIV treatment regimen.  Here is the text of the letter that recounts portions of the interview with which DDMAC takes issue. 

“[T]he most important thing is that I do manage my disease, and it enables me to then

do all the other things. You know, I make sure I take my meds, I make sure that I try

to get some form of exercise. It enables me to also be a businessman once I manage

my HIV.”

• “I started taking Kaletra over five years ago and it’s really been a great part of my

regimen….”

• In response to the question “What has your experience been on Kaletra?”, Magic

Johnson states: “I can still exercise, … I still work and have a long day in the office,

and I think that the medicine has really been good for me….”

• “Well the good thing is, Kaletra is a part of my regimen, and for five years I have been

undetectable, so I just hope that that continues.”

• In response to the question “How has having HIV changed your life?”, Magic Johnson

states: “You’re going to have the same good times. You’re going to, you know, go to

the movies … we just live a normal life …. You just take medicine. We still go out and

dance. We still have a good time, you know, we … take our kids to school …. It’s a

normal life … nothing really changes other than you’re taking medicine and you’re

managing your disease….”

And here is what DDMAC had to say about that:

While these statements may be an accurate reflection of Magic Johnson’s own experience,

as a treatment-experienced individual, with HIV and Kaletra, this promotional testimonial

suggests that Kaletra has been shown to allow all or most antiretroviral treatment experienced

individuals to successfully manage their disease and continue to do well, i.e.,

live a “normal life” while maintaining undetectable HIV-1 RNA levels, for five or more years.

FDA is not aware of substantial evidence or substantial clinical experience to support

effectiveness for five or more years of treatment with Kaletra in treatment-experienced adults.

The personal experience of a Kaletra patient such as Magic Johnson does not constitute

such evidence.

This was in spite of the fact that the sponsoring company had a statement that accompanied the video that stated that "individual results may vary" was insufficient to mitigate the claims that the FDA perceived in these statements.  The FDA felt that specific data to back up the statements made by Mr. Johnson about his experience was lacking. 

Technically, they may be right.  But really?  The FDA isn't aware of evidence that protease inhibitors have worked to stem the nauseating flow of mortality that the HIV epidemic wrought in the 1980s?  Really?  When I came to work at the Gay Men's Health Crisis in 1985, I was one of 18 employees.  There are about 5 of us left.  Today, thankfully, the mortality that became an ugly and every day reality then was crushed out of existence by the introduction of protease inhibitors in the late 1990s and has ever since.  Individual results do vary.  But come on, DDMAC.  Are you really unaware of the efficacy of this entire class of drugs?  You need a history lesson if that's the case. 

Individual results vary for penicillin too.  But hey, it works. 

DDMAC and the FDA might be better off if regulatory enforcement were more concentrated on areas of concern that present true public health hazards rather than actions that, while technically correct, are essentially fundamental hair-splitting.  There are enough real things to worry about without splitting hairs (and spending valuable resources) to find them.