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As one of the presenters on the recent PrEP teleconference, I would like to respond point by point to some of Dr. Sonnabend's statements. As others have indicated, the flyer promoting the tele-conference simply said what the tele-conference was going to be about. It did NOT say that PrEP was going to be effective. All of us who presented on the teleconference were, in my view, clearly stipulating that the purpose of the conversation was to start thinking about what would be needed IF it is proven effective. The reality is that tenofovir and Truvada are already publicly available and will likely move into increased off-label use if the data show that they work for PrEP. It is critical, therefore, that we start talking now about “PrEP readiness" --that is, putting systems in place before PrEP is marketed to make sure that communities can use it safely. And while the flier may not have specified that “PrEP is not intended to replace more traditional prevention strategies”, I was the first presenter and I did address this point explicitly early in my remarks. For verification, please see point 5:27 minutes into the audio recording of the call available on-line at http://media.champnetwork.org/2009/08-August/2009-08-13.PrEP.call/2009.08.13.preptheword.mp3. I used sunscreen as an analogy after a great deal of back and forth with our GCM staff and partners in Africa about what analogy would best help people in their communities to see that prophylaxis is actually a very common practice. We offered the possibilities of comparing it to anti-nausea drugs one takes to prevent motion sickness before travel, anti-malaria drugs, anti-allergy medications taken during hay fever season, contraceptives taken to prevent pregnancy and prophylaxis (like Bactrim) taken by people with compromised immune systems to prevent OIs. They responded that none of these would resonate widely in Kenya and South Africa except for malaria drugs because people don’t have the luxury of ready access to anti-nausea and anti-allergy drugs. Using contraceptives as an example was seen as potentially confusing because it implied that pregnancy is a disease, rather than a condition. They said that some people would connect with taking drugs to prevent OIs when you are HIV+ -- but that this wasn’t a reality for many people. At http://media.champnetwork.org/2009/08-August/PrEP.Briefing.Aug09.color.pdf, you can see a copy of all the slides used during the teleconfernece. You will see that I did mention anti-malaria and OI prophylaxis on my slide defining prophylaxis and I added sunscreen because our African colleagues agreed that people do apply various substances, including very thin mud solutions, to the skin to prevent sun burn. Sunscreen was not mentioned here because we were trivializing the consequences of HIV -- but rather because we were trying to make our information as globally relevant as possible. Clearly, however, this analogy offends some North American audiences and we will have to change it. Another lesson in the impossibility of pleasing everyone. It may also be worth noting that I acknowledged at the beginning of my remarks (please see point 2:40 minutes into the audio recording)that my presentation was going to be unnecessarily basic for many participants. The assignment given to me was to provide a basic introduction to PrEP that assumed no prior knowledge. We design GCM presentations to inform intelligent people who have little, if any, formal education in scientific areas. This is part of our effort to recruit and cultivate HIV/AIDS prevention advocates in civil society. Far from being condescending, we see this as a critically important educational niche and one we work hard to fill well. Discussion about the previous PrEP trials that were stopped was simply not on the tele-conference agenda. We did not have enough time to discuss all that was on the agenda as it was. At GCM, we would be happy to discuss the history of PrEP trials in a separate teleconference if there is substantial public interest in doing that. We have written two in-depth case-studies about what caused the PrEP trials in Cambodia and Cameroon to be cancelled and they are available in line at http://www.global-campaign.org/ethics-resources.htm. I had the good fortune of co-authoring the Cambodia report with Sanushka Mudalair and I think Sanushka and I thoroughly explored what went wrong there in terms of communication between researchers and activists. I agree that this is a very important part of our history. But, for the sake of time and clarity, it is necessary to decide when we are talking about our past and how to learn from it and when we are talking about next steps and how we move forward. Dr. Sonnabend’s statement that ”[p]rovision of condoms, if persistent and effective counseling is provided, will probably mean that there will then not be sufficient seroconversions to be able to measure a protective effect of PrEP” has, unfortunately, not proven true in microbicide trials. I only wish that persistent and effective counseling were sufficient to cause dramatic decreases in sero-conversion among all populations. If that were true, then we could render all women able to insist on condom use simply by supplying enough counseling. Unfortunately, the data show that it’s nowhere nearly that simple. There is substantial literature on this but one particularly cogent fact sheet summarizing available data has been written by the London School of Hygiene and Tropical Medicine and is available at http://www.global-campaign.org/clientfiles/LSHTM-Condom.pdf. It notes that “What this data illustrates is significant increases in condom use often arise following intervention activity, with the greatest increases being in commercial and casual sex. However, there are generally only small increases achieved within steady partnerships. Overall levels of condom use decrease as the degree of intimacy or regularity of the partner increases”. Anyone who finds this statement confusing can probably get additional clarity by asking the nearest heterosexual woman why heterosexual women can’t always insist on condom use with their steady boyfriends or husbands. In my experience, most women have a LOT to say about this, if asked! There is much more to be said in response to Dr. Sonnabend’s discussion of risk, prevention tools offered in trials and the ethical dilemmas inherent in prevention trials. The Global Campaign for Microbicides devotes a lot of time and energy to these issues – working to create an effective interface between researchers, research institutions, civil society advocates and communities hosting research trials where negotiation around these issues can take place. I personally learned a lot about the complexities of this while working on the Cambodia PrEP trial paper and would love to discuss it further. But that is another conversation. Anna Forbes, MSS Deputy Director Global Campaign for Microbicides
Last Sunday, August 23rd, 2009, hundreds of people, including community members, researchers, trial participants, government officials from various agencies, and professionals from various disciplines gathered to examine issues around PrEP. Sessions from "Preparing for PrEP: A Stakeholder's Dialogue," a nearly day-long meeting, are all available online at http://www.livestream.com/PrEP. [Click on 'on demand' to view sessions.]
I agree with the Dr Sonnabend, i understand there might different points of view about the issue but... we must fight ideas NOT PEOPLE. This is not personal issue you are also talking about the lives of many other people and i hope we can keep all discussions in the highest possible level. Yes, this is a serious issue. We have one of those trials here in Ecuador, and i have also been worried about ethical issues of these trials. This is something that has to be analysed deeply. And any data provided from them has to be communicated in an appropiated way cause yes... Prep could help people but we know arvs are not available just like that in all countries... exemple mine. So the few that are available are very expensive and if there is an increase in demand it might affect the prices... and off course big pharma will get rich but i wonder if we will still be able to ensure that medicine really reaches those in need... since we are unable to ensure that simple thing just right now.
I am sorry that Mark Hubbard felt it necessary to mount an ad hominem attack on me. This is a serious issue. Joseph Sonnabend
Dr. Sonnabend, whose admirable place in the fight against AIDS I acknowledge, seems to be confused about the purpose and context of what is but one aspect of a broad outreach effort. It's obvious that Dr. Sonnabend spends most of his time in academia. Presenting at grand rounds is a little different from organizing a broad, open, welcoming community call. Simple metaphors are often appropriate. Expecting the email "flyer" to be a treatise on every aspect of the topic at hand is ridiculous. I'll leave the addressing of factual flaws permeating the piece to others more directly involved. It seems to me, however, that the good doctor is arguing that any biomedical HIV prevention trial is impossible. That's silly. While I agree that providing sterile injecting equipment is important, I know of no evidence to substantiate the claim that if provided "it is pretty obvious that no protective effect of PreP could possibly be seen." The fact is that people are fallible - whether we're talking about condoms or syringes. The fact is that excellent condom usage support has been provided in numerous trials. Still there have been infections. Will he trials be small or easy? No, but nobody said they would be. The vast majority of those on the call were professionals, volunteer providers, and/or community activists. We don't allow one resource to form our opinions. Many of us can actually read. Heck, we even know how to use Google. The only thing I find "condescending" is Dr. Sonnabend's assumption that we who participated on the call are ignorant and helpless. Nothing could be further from the truth. We've been fighting this disease for years, questioning and thinking for ourselves all along. Most importantly, we realize that if there is even a chance that PrEP will work, we must mobilize around influencing a) how the research will be done, b) how any resulting intervention will be operationalized, and c) making sure that the complete portfolio of prevention strategy choices are accessible to everyone who needs them. That means that we don't accept Dr. Sonnabend's pose as some wizard of PrEP - benevolently waving his wand at the populations HE thinks should have access to it if it's proven effective. We'll insist on participating in the process using our own unique intelligence, wisdom, and insight, thank you very much.
Richard Jefferys
Hi Joe, I regret to say that I think this post is both poorly informed and hugely unfair. CHAMP and others have been working on issues related to PrEP for a long time and there have been extensive prior discussions and exchanges on listservs including much discussion of the cancelled trials and sharing of reports and videos about what happened. Pronouncing harsh judgment on people based on participating in one conference call is just not a cool thing to do. Best wishes, Richard
September 9, 2009