24/01/10

Is CDC’s HIV prevention trial in Thailand ethical?

How ethical are HIV prevention trials? Every time we announce results of a trial that compares new HIV infections in a group with or without some new intervention (a microbicide for example, or a vaccine), some journalist or other jumps on the fact that researchers are just watching people get infected. Researchers then explain that everyone in the trial gets given the best possible existing prevention services — counselling, free condoms, treatment for other sexually transmitted infections. But is that really true?

The question was raised for me while I am here in Thailand by a comment on an earlier post. It pointed out that US taxpayers, through CDC, are funding a trial among drug injectors in Thailand that withholds the very thing we know will prevent most infections: sterile needles.

CDC, on its website, points out that withholding clean needles is “consistent with Thai government policy”. And yet the agency itself recognises that needle distribution programmes reduce HIV infections. The Helsinki declaration on medical research ethics says that if you’re trying out a new drug or procedure, you’ve got to try it against the best available alternative.
In the past, I’ve argued that it is reasonable for us to read that as “the best alternative feasibly available in the country where the study is being done”. There’s no point trying a drug designed for use in a developing country against a developed-country regimen which is likely to be better, but which couldn’t ever be offered in the study country because it requires too much money, technology or expertise to administer.

The “we’re using the Thai standard of care” argument is very convenient for CDC researchers. After all, they need quite a few people to get infected, so that they can see if significantly fewer people get infected if they’re using the trial drug, tenofivir.* CDC’s other tenofivir trial, among women in Botswana, has just been downgraded, because the research team has realised that it is not getting enough infections in either group for it to be able to measure a difference. That’s in part because of very high drop-out rates — already a red flag for a prevention method that obliges you to take a pill a day for as long as you’re at risk.

We know that an adequate supply of sterile needles, and the freedom to use them without fear of arrest, can cut HIV infections dramatically among injectors. If the CDC study in Thailand gave enough needles to injectors, they probably wouldn’t have enough infections to give them a trial result. And the tenofovir-based prevention method that’s being tried is a method that could be used by other groups too — gay men and sex workers and other heteros at high risk of exposure, for whom we don’t have such easy prevention options. So you can understand why researchers are reluctant to push the envelope on providing decent prevention to study participants. But in this case, the “local standard of care” argument really doesn’t wash. It would be perfectly feasible for Thailand to provide injectors with clean needles. The country has the technology, the money and the health systems to do that. The only block is a political one. It’s bad enough that Thai authorities live with this blind spot in their otherswise quite pragmatic HIV prevention programme. The US has been just as bad at home, although there’s now light at the end of the tunnel for safe injecting programmes in the US. All the more reason that US researchers (and taxpayers) should refuse to compound Thailand’s unethical policy with unethical research.

*Info on the trials: The Thai and Botswana trials aim to investigate whether uninfected people can take a daily dose of antiretroviral drugs to stop themselves getting infected with HIV if they are exposed to the virus through sex or needle-sharing with infected people. It’s know as Pre Exposure Prophylaxis or PrEP, and you can find our a lot more about it here.

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This post was published on 24/01/10 in Science.

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  1. Comment by Anonymous, 24/01/10, 08:26:

    From the CDC site:
    “Consistent with Thai government policy, sterile syringes are not provided, but are widely available in Thailand without a prescription and at low cost (one sterile syringe and one needle cost about 5 baht, or about $0.15).”
    Do we know what motivated the Thai government policy? Was it bound up with the older US governments’ attitude to clean needles?

  2. Comment by admin, 24/01/10, 01:36:

    As one of these programme managers who had to deal very recently with an ignorant and dangerous blogger who did a lot of dammage (I’ll tell you more next time we meet), I think it is a bit disingenuous to say that researchers “need quite a few people to get infected”.

    Researchers do not “need” people to get infected. People *will* become infected, trial or not. I don’t dispute your argument but the impression given, once more, that those willing participants are used like guinea pigs. Whilst it may have been the case in the past, it is not anymore due to the strengthening and tightening up of ethics and regulatory aspects of conducting a trial.

    In this regard, it is also unfair and untrue to suggest that “researchers are reluctant to push the envelope on providing decent prevention to study participants.” Participants in the trial I am familiar with often receive better care than the “standard of care”. The recent change in HPTN 052 is a reflection of this.

    The local standard of care is often not “the best that can be done” but rather “the best the government is prepared to do”. It is not for researchers to refuse to compound with government unethical policies, but for the civil society to do so. South Africa did it with TAC and access to treatment. Thailand is failing doing it with IDU because overall Thai people don’t care about IDU as demonstrated by the large support former Prime Minister Taksin and his “war on drug” policy got in 2003.

    It is misplaced to blame researchers for the failure of the civil society.

  3. Comment by John, 24/01/10, 04:46:

    i never really thought of the process that some of these trials take on but after spending a lot of time in issan where a lot of the former sex workers come home to die you see the aftermath of HIV aids and wonder why more is not being done to help everyone

  4. Comment by Robert, 25/01/10, 11:54:

    Thanks eliza

  5. Comment by Rieza, 04/03/10, 10:35:

    Elizabeth–sorry for repost (if this becomes one). PrEP is one of those things I think belongs in Fluffy La La Land. I do hate to be the Debbie Downer of the party, but: 1. who will fund PrEP, if it ‘proves’ to be efficacious? From my understanding, there are 6 trials running thru 2012 (curiously, only one is focused on MSM), and 2. more importantly (and related to item 1), who qualifies to be on PrEP?

    Re: the syringe exchange ethical scandal. The CDC researchers say it’s b/c of ‘local standard of care’, but we know better. I think the real reason is the ban on using federal $$ on needle exchange, which our lovely friend Ronnie Reagan introduced in HIS ‘war on drugs’, and our other friend Bill Clinton didn’t bother to remove during his 8 yrs in office. The Thai trials started in 2005, so @ the height of the Bush administration, and we know HE wasn’t gonna do anything to get rid of it. For many many years, needle exchange programs have had to get $$ from locals/state hlth depts (and we see their efforts have paid off in the decreasing # of new HIV diagnoses due to IDU), so we kind of see the lifting of the ban as too little, too late. However, going back to the Thai trials, if even American (tax-paying?) junkies and the ppl trying to give him safe injection kits couldn’t use fed $$ for clean needles, what’s to say that Thai junkies would be able to get the goodies from the US gov’t?

  6. Comment by Michael Ozanne, 06/08/10, 11:15:

    Ms Pisani,
    i have a worry about PrEP. As I recall widespead penicillin PrEP practiced by US soldiers on R&R from the Great Asian Vacation (Vietnam War) was what ultimately gave rise to the “holy crap fire just shot out of my dick” strains of anti-biotic resistant syphilis and gonorrhea in the Phillipines and Thailand during the ’70′s.
    I have no course of action to advocate, but isn’t there a risk that presenting fresh infections with insufficient overkill may give us a hardier HIV that we could well do without…?

  7. Comment by elizabeth, 08/08/10, 05:39:

    Michael
    You’re right to be concerned. Tenofivir, one of the antiretroviral drugs currently being tested for PrEP, is an important first-line therapy for people who are infected. The main problem with developing resistance is when PrEP fails and people become infected but carry on taking the ARVs as a prophylactic. Low or intermittent doses of ARVs designed for prevention may allow the virus to mutate more easily in people who do not yet know they are infected.

    On the upside, preliminary safety data released at the recent AIDS conference in Vienna suggest that there is not yet any evidence of such resistance developing in practice. Watch this space.

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