Dear FDA CTP: Nothing about us without us!

by Carl V Phillips

As many of you know, CASAA has been leading the campaign to have genuine consumer representation in the tobacco products regulatory process.  In most everything else the US FDA does, particularly including the regulation of medicines, there is an institutionalized system for consumers to be represented.  By contrast, for the Center for Tobacco Products (CTP), which regulates products that consumers should have a much greater say in than medicines, we have had to elbow our way in to get heard at all.  (While there is obviously good reason for consumer representation in medicines regulation, consumer goals are not complicated — everyone wants to be cured — and the experts tend to know a lot more useful information than the consumers do.  Neither of those is the case with tobacco.)

The mantra is “Nothing about us without us!”  It is unethical (and impractical) to make regulation without the people who are affected being involved.  In Europe they have a system that basically excludes the people from the regulatory process, but in the US, the system is set up to include the consumers — the primary stakeholder, and the most important stakeholder by far.  But it is not being done in this case.

On CTP’s semi-external advisory committee, the TPSAC, there is a seat for a consumer representative.  It has been held by someone who is about as manic an ANTZ as exists.  If she had her way, consumers would just be eliminated.  It is difficult to think of a worse representative for consumers, and the rest of TPSAC are not much better even though most are supposed to be objective scientists.  Indeed, at the last TPSAC meeting (you might recall my live blogging of it), Tim McAfee from CDC was sitting in ex officio, and he was speaking up for consumer interests better than any of the regular panel members.  For those who do not know, McAfee is a long-time ANTZ and has played a major role in CDC’s recent lies about children using ecigs (which I just realized I have not posted about yet — coming within a few days).  So when he is your best advocate, you know you have problems.  Well, second best advocate, because the representatives from the traditional tobacco companies do a pretty good job too — but the same “you know you have problems” caveat applies there too.

I recently presented at a scientific workshop at CTP, which went pretty well.  At the end, the host — a genuinely good and concerned FDA staffer, who seems to really “get it” — expressed his appreciation that members of different groups could dialogue.  He identified the groups that were present as including the FDA, research scientists, the industry, tobacco control, and “others”.  Yes, the primary stakeholder, consumers, were just called “others”, while a bunch of non-stakeholders were identified specifically.  (I was really the only consumer representative there, and I was mostly wearing my “research scientist” hat.  But I did speak up several times on behalf of consumer interests, and my presentation was very consumer oriented.)

We need to chip away at this every chance we get.  And if you are reading this by tomorrow morning, you have a chance to make a small contribution.  The CTP director is doing a webinar tomorrow afternoon (Eastern Time), and is accepting questions via Twitter (and also email).  Please tweet the following message or some variation thereof:

@FDATobacco #AskDirectorZeller When will there be genuine consumer representation in the CTP process? Nothing about us without us!

I urge you not to tweet a bunch of other questions also.  If you have one other burning question you want to ask, do so, of course.  But if you tweet several questions, you will be ignored.  Also, I would bet that they will only take one or two questions about genuine consumer interests, so let’s make it hard for them to ignore that one.  Otherwise, they will just pick a couple that are trivially easy to answer and ignore the most important one.

[UPDATE, evening of the same day: I just sent this email to CTP…

Dear CTP:

By now, you have no doubt seen the many CASAA members tweeting a question for tomorrow’s webinar, asking when there will be real consumer representation in the CTP process.  I am writing to translate that question into a few more words than are possible via Twitter.

First some background observations:

The CTP process has heavily involved industry, the secondary stakeholder, and tobacco control, a special interest group that is not a stakeholder at all.  (The term “stakeholder” refers not to anyone with a role in the process, but specifically to people who have something at stake in the matter.  Tobacco control people may have an opinion about what is best, but they do not have a stake in what happens, other than in terms of keeping the tax money flowing in their direction.)  But the primary stakeholders, the consumers, have had to claw their way into corners of the process, and that has left them with a trivial role compared to the special interests.

This is the way things naturally work in regulation, given issues of concentrated special interests and diffuse public interest, which is why government tries to act to ensure that the primary stakeholders have some voice.  FDA does this all the time, such as having patient representatives involved in discussions of medicines regulation.  Right now, though, the only seat at the table available for consumer representation is a seat on the TPSAC, which is inappropriately occupied by someone whose interests are diametrically opposed to those of tobacco product consumers.  We realize that Director Zeller cannot decide who holds that seat, but that does not change the fact that this situation is clearly a problem and a slap in the face to consumers.

To our knowledge, no consumer representative has ever been an invited speaker at a CTP hearing or other forum.  We have been relegated to the few slots on the agenda open to supplicants.  This contrasts with members of the aforementioned special interests who have repeatedly been invited to speak.  Even if the glaring problem on the CTP cannot be solved by a decision of the CTP staff leadership, this problem can be.  Moreover, we suspect that some sort of ex officio role could be granted in the TPSAC process, given that there have been ex officio participants in TPSAC meetings.

Now the fully phrased question itself (though you could always just answer the simplified version as phrased in the tweets, of course):

Currently consumers have no institutionalized voice in the CTP process and are relegated to begging for attention, while the industry and those who oppose consumers’ interests are invited to play active roles in the process.  This will continue to be the case unless CTP takes affirmative action to change it.  What does CTP plan to do in order to remedy this unacceptable situation?

Carl V Phillips, PhD – CASAA Scientific Director

[UPDATE 2, 16 Dec] — Sorry, a bit late with this…

The aforementioned webinar took place as scheduled.  During the question session, our question about consumer representation was the second that Director Zeller responded to (after a general one about CTP’s position on harm reduction, in particular via e-cigarettes).  Unfortunately, the audio dropped when the question was being presented by the moderator, so we do not know exactly what form it took.  Presumably it was something generic like “there is concern that there is not adequate consumer voice” rather than our exact tweet.

He led off his answer with, “I was troubled by comments by anyone who thinks their voice is not being heard.”  This has at least two possible meanings, but I interpreted as having the more positive interpretation.  Unfortunately, the response continued by emphasizing that they had had public meetings, suggesting these addressed the issue.  Of course, this kind of misses the point:  Yes, consumers can petition the government as supplicants, but that is not the same as having an institutionalized voice.

Fortunately he continued by saying that he was committed to consumer representation, but we have to do it within the bounds of the law.  I think the caveat was merely an oblique reference to the fact that if the “consumer representative” slot on the TPSAC is filled by someone who is adamantly opposed to consumer interests, there is nothing he can do about that.  It is certainly within the bounds of the law to include invited presentations from consumer representatives at meetings that include invited presentations, and we hope this will happen.

He finished with “you have my commitment” to ensure consumer voice, and “we will endeavor to do better.”

Genuinely good news, I think.  A lot can still go wrong for consumers in this process, but at least it is not European-style.

I learned from the webinar one technical point to keep in mind:  Right now, when “individual” comments are submitted to the docket (i.e., this apparently gives an advantage to organized interest groups over the people), they are read but they are not posted into the public record.  Thus, it might be a good strategy for consumers to send paper (ugh!) copies of submissions during future comment periods, and explicitly say that they want their comments in the public docket (assuming they do, of course).

In response to the questions about e-cigarettes, Zeller emphasized that CTP “cannot” (read: will not) make policy based on the reported good experiences of users, and that population-level effects must be considered.  Fair enough, though we are all waiting to hear what this means.  They have been asked about that a lot (in more formal forums) and have pointedly refused to answer.

On a personal note, I thought I detected a bit of influence of my scientific work in his comments about how this would work.  I have been pushing them to recognize that their standard calls for making predictions about how people will respond (e.g., to a novel product or a label that says one product is lower risk than another), and that such predictions require modeling actual human preferences.  Previously, there had been a notion that some simple arithmetic could substitute for this, but that may be changing.

And as a random funny note, the webinar had a realtime voice-to-text feed running.  It kept talking about “ease cigarettes”.