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


• 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. 

This entry was posted in FDA Policy. Bookmark the permalink.

2 Responses to A Warning Letter Story

  1. Anoop Kumar says:

    Dear sir,
    I have recently visited your blog and I also have three blogs related to healthcare and lifesciences and chemicals. So, I want that you will place our links on your blog blogroll section and then I will place your links also on our B2B portals .
    The links are given below:
    Once you will place our links, then please inform me by giving a mail. As soon as I recieve your mail, I will place your links to my Directories.
    Thank you
    Anoop Kumar

  2. Veritatis Cupitor says:

    Eye on FDA Summary – 2nd Quarter, 2009
    There may be a pattern of even greater non-interest (if that’s possible) emerging at Eye on FDA. There are a number of vectors by which one can ascertain the level of interest, or lack thereof, in Eye on FDA posts. One such area is the posting of comments by readers of the blog. In this installment, we examine solely the number of posts and comments, followed in a future posting by commentary on the absolute uselessness of complaining about a problem rather than dedicating yourself to fixing that problem.
    Looking at the numbers from Q2, the number of postings by Mark seems to have remained stable: 13 posts in April, 16 posts in May, and 15 posts in June. Unfortunately, I do not have any interest in researching posts prior to this, but I’m sure someone has the data and can do the same calculations (right Mark?). Regardless, I think 1 quarter is sufficient to make my point. Now let’s look at the overwhelming response of his readers to these 44 posts. In April, the postings were so informative and thought provoking that a whopping 16 people posted comments. Followed in May by 14 comments and June with 24 comments. Now mind you, I did not go through all the comments and eliminate possible double postings by the same commenter or Mark’s reply to comments, so the actual number of posters is likely lower. Looks like an average of 1.2 comments per post. Outstanding! Looks like you are really provoking some thought and inspiring the masses to call for change at the FDA.
    Now, let’s put that number into some perspective with an analogy I’m sure you will appreciate. The typical Whac-A-Mole (correct spelling, sorry Mark, attention to detail please) game has five holes on top of a waist-level cabinet. Now the moles appear in random order… but around 1 mole every 2 seconds for 60 seconds, totaling 30 mole appearances per game. If I were to average 1.2 successful whacs (comments) per game (posting), then surely you wouldn’t consider me a very good Whac-a-mole player, would you Mark?
    A note of caution when interpreting the data, Q2 numbers include the absurdity of 10 comments to 1 post on June 16 which inflates the average considerably and artificially. Guess what that post was about?….Social Media and DDMAC. In fact, this seems to be a record number of replies to 1 post for your blog. Tied for the second highest number of responses was the April 6 post on…(wait for it, wait for it)… the 14 NOV letters by DDMAC. Seems to be a correlation emerging here between interest in your posts and DDMAC. Perhaps you owe DDMAC a little gratitude for making your posts interesting, albeit to a small, small number of readers.
    Is non-interest in Eye on FDA ratcheting up? Only more time will tell. In the meantime, I’ll continue to look for new signs that Eye on FDA has any significant readership or impact on public health. I’ll also continue to push Mark to reveal the real reason he continually bashes FDA…and it’s not for the protection of the public health…is it Mark?

Comments are closed.