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Myles Helfand
October 21, 2009 The Thai HIV Vaccine Trial: Is It a Big Deal or Not? Subscribe to Myles' Blog or learn about blog subscriptionsIf you're feeling a sense of whiplash over the recent barrage of HIV/AIDS vaccine news, you're not alone: Public reaction to the initial results of the RV144 Thai HIV vaccine trial felt like a roller coaster. First came the over-the-top headlines hailing the results as a veritable miracle of science. Then came the over-the-top headlines calling the results into serious doubt. Now, vaccine experts and advocates are scrambling to prevent the world from dismissing the study entirely: Seth Berkley, the head of the International AIDS Vaccine Initiative, wrote an empassioned op-ed piece in the New York Times on Oct. 18, and Raphael Dolin, M.D., a prominent infectious disease doc at Harvard Medical School and an authority on HIV, urged a rational approach to the story in an article published in the New England Journal of Medicine. (And to their credit, a smattering of more recent news coverage, including an Associated Press article and a well-written update by Donald McNeil Jr. of The New York Times, provide a pretty balanced take on what the study results mean.) This is, admittedly, often the way of things for us humans: Major news breaks and we go nuts about it. Then we go nuts about how nuts we got about it. Then we decide everybody overreacted about everything, it wasn't that much of a story to begin with, and we forget about it and move on to the next story to go nuts about. But before the results of this trial are dumped into the sink and drain away into the abyss of history, it's important to make sure the story leaves the proper aftertaste. What are we left with? Did all this hubbub ultimately mean anything? To be sure, it wasn't the best idea to hold a major press conference announcing clinical trial results that only barely reached statistical significance (and even then, only in a certain type of analysis). We know how mainstream media tends to react to breaking stories with pithy headlines, and this one was destined to be blown out of proportion because of the way in which it was first announced. (The same thing happened four years ago when the U.S. was whipped to a frenzy after then-New York City health commissioner Thomas Frieden decided to publicly announce that an area man had developed a rare, rapidly progressing strain of HIV that was "difficult or impossible to treat." He ominously warned that it could potentially mark the beginning of a new HIV superstrain. Within months, the man was doing well on HIV treatment, and no sign of superstrain outbreak ever emerged. Frieden, incidentally, is now the top dog at the U.S. Centers for Disease Control and Prevention.) But how much can you really blame these folks? It has been a bad, bad, bad run for AIDS vaccine developers. It was less than two years ago that a spate of poor study results had experts admitting that no real progress toward an HIV vaccine had been made in two decades, and left many wondering whether there was any point in continuing efforts to develop one. For nearly three decades now, the search for a vaccine that can prevent HIV infection has been an effort largely defined (at least to the public's eye) by its failures rather than its successes. Then suddenly, for the first time ever, a huge study shines a faint ray of hope. If you've been sitting in the dark for more than 25 years waiting for some sign, any sign of light, and you finally get it, wouldn't you want to shout "Hallelujah" from the rafters? I am by no stretch of the imagination a vaccine expert. And based on the information I've read, I'm trying to be realistic about this. Sure, odds are the "prime-boost" vaccine tested in this study is not going to be The Answer. It may even turn out to be a complete dead-end, an approach that will never confer more than a marginal protection from HIV at best, and won't even spawn new successful avenues of AIDS vaccine research. But a large part of me can't help but take an optimistic view of this story, even if it's admittedly a little naive. That part of me thinks that maybe this vaccine somehow will turn out to be The Answer. Or that maybe something about the study, something about the findings, will set off a spark in a researcher's brain that leads him or her to discover a method of preventing HIV that does prove to be The Answer. We just don't know, and won't know for a long time to come. But for the first time in a long time, something major has happened to give us hope that a successful AIDS vaccine is out there somewhere, just waiting to be created. And that, if nothing else, is reason enough for me to come away from this feeling a little better about where we are in HIV/AIDS than I did before.
Copyright © 2009 Body Health Resources Corporation. All rights reserved.
Comment by: Ajithkumar
(Kerala,India)
Sun., Oct. 25, 2009 at 9:50 am EDT Yes I remember those days we never had any treatment to offer my patients. But a kindle of hope kept them going ... and kept them alive till ART is available. Without that hope may of them would have opted to end their lives...Again I remember I never used to give them false hopes... so let us hope .. keep hoping... and have realistic hope on an HIV vaccine.. just enough to keep us trying...
Comment by: Robert
(Toronto)
Sun., Oct. 25, 2009 at 12:02 am EDT I hope this goes to everyone... imagine the huge battle that this vaccine, THIS HOPE, has had against not only the HIV, the battle against the media, against the big companies that design the way in which YOU take a pill today and be sure that YOU take it tomorrow, not for YOU, for them!... Let's follow and support the investigation from every single home that feels affected or not by HIV. Sorry but I think, my personal opinion, that during this decade it is not only a virus, it is the whole system around it, so this HOPE for the life of everyone is affecting or is going to affect other's money. I believe in love and life.
Comment by: Steven S. Muchnick, PhD
(San Francisco, CA)
Fri., Oct. 23, 2009 at 1:32 pm EDT Yes, the modified-intent-to-treat (MITT) result of the RV 144 Thai vaccine trial was only barely statistically significant to begin with and the other two analyses showed no significance. Yes, the difference between the numbers of those infected in the treatment arm and the placebo arm were small enough (in a general population, not a high-risk one) to be somewhat questionable. Yes, one of the two vaccine candidates used in the trial showed no statistically significant result on its own, and the other never even proceeded to Phase III trials alone. On the other hand, this is the first Phase III vaccine trial to show a statistically significant result in any population, and it would be wonderful if the result could be replicated in a trial with high-risk participants. If the results were borne out, it would be a wonderful step in the right direction. As Dr. Lawrence Corey, Principle Investigator of the HIV Vaccine Trials Network, has been quoted as saying, getting from 30% efficacy to 60% efficacy is a lot easier than getting from 0 to 30% -- and 60% is licensable. So, it's important that we not dismiss the results out of hand. Let's keep open minds and see how this develops.
Comment by: Gilbert
(Pompano Beach, FL)
Fri., Oct. 23, 2009 at 10:49 am EDT I agree 100% with your sentiments. We need to continue having hope even if it's short-lived. Continuing having the feeling of hope will give us a reason to continue living with HIV and for those who will or may contract HIV. Thanks for your spin.
Comment by: song
(Washington)
Fri., Oct. 23, 2009 at 1:52 am EDT such negative about everything and maybe should think about possitive. Maybe you should try learn more about journal or read more medical book. If someone came out with good paper or journal and should give them Wow.... Maybe some people love to read about negative thing. I think their research that will give hope. They asked many people that we have hope. I believe someone is very smart and will someday to help people with HIV. They will feel much better and no hate. Send many love to them and hope one day they feel better....
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The Viral Truth: Making Sense of HIV/AIDS News ![]() Myles Helfand Myles is the managing editor of TheBody.com. He has been reporting on HIV/AIDS since 2001.
Subscribe to Myles' Blog Recent Posts: October 21, 2009 - The Thai HIV Vaccine Trial: Is It a Big Deal or Not? October 1, 2009 - ADAP Coverage Struggling in Many States, Leaving Many HIVers in the Lurch September 23, 2009 - 25-Year Prison Sentence Vanishes for Man Convicted of Not Disclosing HIV Status September 9, 2009 - How Long Will You Live With HIV? Take Studies With a Grain of Salt August 19, 2009 - Kaletra and Gemfibrozil (Lopid): A Match Not Made in Lipid Heaven August 5, 2009 - HIV (Apparently) Comes From Gorillas: What This Means for the HIV Community Articles by Myles:The Latest on H1N1 (Swine Flu) and HIV Life Expectancy Continues to Rise for HIVers on Treatment, Huge Study Finds (July 28, 2009) Thinning Bones a Growing Problem Among People With HIV; HIV and HIV Meds Appear to Be Culprits (July 8, 2009) U.S. to (Finally) Begin Removal of Ban on HIV-Positive Visitors (July 2, 2009) Iowa Man Sentenced to 25 Years for Not Disclosing His HIV Status (May 20, 2009) |
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