May 5, 2010
by Tim Horn
Is it possible that enrollment in START, with its deferred treatment arm, will be considered unethical in light of the DHHS guidelines revisions and specific groups pushing for immediate treatment? Collins doesn’t think so, despite the fact that the potential for an ethics conundrum was raised in the START CAB sign-on letter. “After speaking with a wide range of advocates and researchers in the U.S., it’s clear that many take what they want from the guidelines and do what they want otherwise,” he says. “It would be nice if this were publicly known, however.”
Milano agrees and says the language employed by the guidelines panel and other groups is tricky and should be clarified, so that people living with HIV and their care providers know that they do in fact have options. “The DHHS guidelines say over and over again that they are just that—guidelines,” he says. “If doctors would stop using them as rules, it would not affect enrollment of START. If the panel members felt that cohort studies argue for earlier treatment, it would be unethical to withhold their ‘recommendation’ just to help START enroll. But they need to emphasize that the new guidelines are—as they have usually been—a best guess, and that START should move forward.”
Huff doesn’t doubt the merits of START. “I agree that a large clinical trial of this question is essential, but I don’t think communities should be restricted from doing what they think is best at this point based on available data.”
He also argues that the push for early treatment by some cities and local organizations shouldn’t be viewed as a direct threat to the study, but rather an opportunity for supplemental learning. “I don’t think a nationwide recommendation by the CDC or the guidelines committee is warranted by the evidence at this point, and neither does the committee, apparently,” he says.
“The experience [in San Francisco] will feed into the forming and shifting ‘cloud of consensus’ on this question over the next several years,” he says. “I expect researchers in the city health department and elsewhere will report on the impact of the campaign. I hope Project Inform also reports on its experiences with communicating its position in the community and what it learns about the range of individual experiences with quality of care, protection of rights and respect for people with HIV as this program goes forward. If universal testing and treating become the standard of care in the future, other cities and organizations will look to the experiences in San Francisco and other pioneer cities to learn what worked and what didn’t.”
Project Inform stresses that it supports the need for, and completion of, START. “The study’s main endpoints and data from its many planned sub-studies can only help to define the best time to start therapy.” When asked why it didn’t include a reference to START—and the controversies it hopes to settle—in its position paper, Van Gorder says that it didn’t mention the study “because START, among other study data, will be more carefully discussed [elsewhere on Project Inform’s website].
“Given recent changes in earlier treatment advocacy, concern for fully enrolling START is understandable,” he adds. “Project Inform wants to see START fully enrolled and completed, and will work with its CAB to support successful implementation of the study.”
Collins says he hopes the sign-on letter will lead to an even larger national dialog about the DHHS recommendations and emerging public policy favoring immediate treatment. “This is almost creating a panic to get on treatment, when we already know that at high CD4 counts there is rarely any urgency for treatment. We are saying that we want to see the evidence of both the risks and the benefits.”
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comments 1 - 15 (of 21 total) next
G-B, USA, 2010-06-22 13:06:36
SMART is not about the best treatment for individuals, but lowering the community viral load, so transmissions decrease. It assumes poz people are transmitting it, rather then untested. It's unethical. And of course they are touting the health benefits of starting early, to convince people. After 5 years with no meds, my viral load is still at 200 and my CD4s are high. Why would I start meds that in the long run may prove to be worse for my health, after being on them for 40 years???
Frederick Wright, Tampa, 2010-05-25 11:35:00
This debate about when to start or what is a safe dose of ARV's for people is surprising that not one of the National AIDS/HIV groups from Housing Works, NMAC, AIDS ACTION , The AIDS Institute, NAPWA or State AIDS Leaders AKA employees of the States are taking a stand or position. Where is the Leadership? They are waiting I guess to inform the people they serve when it is safe to speak and act. Silents equal Death and clearly new leadership is needed within these so called AIDS Non Profits.
Tim, Pittsburgh, 2010-05-19 17:05:16
Since when is a Community Health Outcome the goal of a individual's treatment plan?
Christopher, , 2010-05-19 02:59:11
"If patients are ready and willing, go for it !!! Promote a health immune system!"--not much of an argument there; sounds more like a high school cheerleader or an advertising exec than a real doctor. This disturbs me. 20 years from now, are some of those patients going to have kidney damage who might have avoided with, potentially, ten fewer years of HAART?
Christopher, , 2010-05-19 02:57:28
(cont.) "Delayed western blot positivity,"--is that important?--"undetectable viral loads and CD4's 800-1500." Your patients will, now, never know how many med-free years they would have had, which is sad. I've had HIV for six years now and have done fine without meds; can you give me an argument why taking HAART these six years, and counting, would have improved my life?
Christopher, , 2010-05-19 02:51:41
Christopher G--I'm surprised at your statement. You write "I try to start all of my new (acute) HIV patients on HAART - all have done very, very well"--most of them would have done very, very well even without HAART; we'll never know, now, for how long--"and I haven't seen any negative outcomes."--is this meaningful? What kind of negative outcomes were you likely to find? The arguments against early treatment come from the unknown effects of decades on HAART. Get back to us in 20 years, ok?
Matt, Raleigh, NC, 2010-05-15 13:31:55
Article says nothing of VL in respect to starting treatment. I was recently diagnosed. My cd4 count is 366 and undetectable VL w/o treatment.My doc tells me my body is controlling the virus and meds are not necessary right now. With the information in the article and comments below, I am wondering if I should start treatment sooner rather than later.Docs tell me that treatment is not necessary til VL over 100,000 copies.But not excited to wait to get sick to start treatment.
Frederick Wright, Tampa, 2010-05-15 09:24:18
Tim, I am in agreement that folks should start meds when they choose in agreement with their Doctor. And Thank God for all the people before me that took these experimental drugs, some died, some live. Which makes these drug better in science and community. The problem for me is what is the right safedose, for many say take them like they are prescribed, while saying ever one is different. Does not make since if all are different for all to take the same dosage. This is not about when to start
OriginalTim, , 2010-05-14 10:32:50
I fully support starting meds as soon as possible. I took this decision as a life changing event. I was tired of waiting till I got sick to start meds. Every day waiting on my labs to come back was an extra day of unneeded stress. The meds are safe now so I started when my cd4 was well above 500 and I have not been sick a day since, not even a cold. Furthermore, the stress of waiting on my health to decline has been eliminated. I can now live my life to the fullest.
Rosetta, Buffalo, NY, 2010-05-12 12:37:46
We have been seeing for years the physical challenges from long term use of HARRT. I think this is just a way to prevention the transmission of HIV, so that's what they should say it's about!
Frederick Wright, Tampa, 2010-05-12 10:56:09
Yes, a piece of the truth would be nice and I am very happy my Faith is not in a Study or a Doctor for the confusion is in the term experts. Project Inform is an expert at data, which according to the National Physician Alliance can be mis-leading by Doctors signing off on anything that the Drug Companies want them to do. The other confusion is that Doctors are the experts in handing out pills, however the HIV person is the expert on taking pills. Craig thanks for addressing this debate.
Craig, Orlando,fla, 2010-05-11 14:14:55
Well to tell the truth. I am still undecided on the whole matter! I understand that the risk of starting early would be the potential side effects of long term meds! Now on the other hand it could be that the side effects are worse in folks whom wait till the below 300. It could be that since the virus is so rampant that the meds effect the rest. So I think instead of all this crap about who said what and when. We should wait for the results of the START study! Then make a choice with your doctor
Frederick Wright, Tampa, 2010-05-09 13:28:40
Again out of date and Tim Horn is reacting not leading. I am not suprized that this conversation is out dated compared to Europe where Titration of Drugs is a treatment option. Most people here do not know or understand Titration of Drugs and again the lack of leadership in the USA is so riddled with false information. A study that is short sided. Concerning Mr Picket comment about money, Why are the Drug Companies not coming down in price after 10 years of having a cash pig from Medicare.
Frederick Wright, Tampa, 2010-05-08 09:39:13
The sad thing about TNT is that it adresses a small part of treatment focus at pills, where nutients and life stye changes should be adressed, like if t-cells are below 500 stop using cocaine and eat well, and find a loving mentor that will help you think and act in your community. Concerning Mr Picketts concerns about money it would be less expensive to treatHIV people and notAIDS with huge hospital bills then a 50 cent drug a month that PHARMA sells to our Goverment for thousands dollars
Vanessa Anderson, San Diego, 2010-05-06 11:16:03
comments 1 - 15 (of 21 total) next
I chose to participate in the study and started my antivirals at a tcell count of 600. It has changed my life. I wasn't completely aware of how tired I was before and what a struggle everyday really was i had been doing for such a long time. My viral load is now undetectable and my tcells are at 950. I have more energy and although it can be a pain in the butt to remember to take them everyday my quality of life is back to were it was before i was infected.
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