Infrequently Asked Questions

Paula Donovan Answers Infrequently Asked Questions: For Women, Is It Guilty Until Proven Innocent?

Wed, 20 Apr 2011 08:55:00 -0400

By Paula Donovan

FHI announced Monday that it had discontinued a clinical trial designed to determine whether women at high risk of contracting HIV could be protected against infection by taking the antiretroviral drug Truvada. Interim findings showed that the once-a-day pill hadn’t worked. Nearly 2000 women were enrolled in the study between 2009 and mid-February of this year, and divided at random (and without participants’ knowledge of their assignments) into one group that would receive Truvada and another that would take a placebo. An independent data monitoring committee found that 56 participants had become infected with HIV — an exactly equal number in each group. The study was halted, given the strong indications that, unexpectedly and for reasons not yet known, daily Truvada will not prove effective at preventing HIV in women.

Clearly, the findings are terrible news; hopes were high, especially given good results from an earlier trial that tested the same drug’s effectiveness in preventing HIV infections among men who have sex with men.

Equally clear was the bias against women boldly displayed by media outlets worldwide that reported today’s news — and indeed, by the authors of a statement released to the press by FHI, which led the study. No one yet knows why the trial failed, but that absence of scientific evidence didn’t deter any of the journalists, nor FHI, from casting doubt on the women who took part by focusing first and foremost on the possibility that they messed up. Each first clarified what is true — that no evidence has yet revealed the reasons for the study’s failure — and then proceeded to theorize. And with shocking consistency, in every single case (though no scientist has reason yet to lean toward one theory over another), the very first possible cause that FHI and then reporter after reporter listed was the likelihood that the women had done something wrong. No news article among the dozen I read gave any other untested theory top billing: every account of the study’s heartbreaking findings made women Suspect Number One.

“There are four possible explanations for the failure of the study…” reported the Washington Post. “One is that the women weren’t taking the medicines as instructed, despite assertions they were.”

Of course, scientifically, that’s illogical; since no cause for the failure of the study has been identified or excluded, we’re left with an infinite number of possible explanations.

“Why did the drug do well with men but not women?” asked an editorial in the San Francisco Chronicle. “Did the women take the drug faithfully as required?”

The Associated Press (which may well have misquoted the doctor who ran the previous study among men who have sex with men — a doctor who will therefore remain unnamed here), artfully positioned quotation marks around phrases to end up with this comment about the current study: “it’s difficult to understand why they did not see protection” but blood samples may tell more about whether it’s related to how faithfully women took the pills, said Dr….

That’s right — blood samples that have not yet been examined. Innocent until proven “faithless.”

TIME Magazine wove these bits together to craft a “quote,” making it appear that Dr. Anthony Fauci, the Director of the US National Institute of Allergy and Infectious Diseases, naturally suspects that all sex workers lie. After noting that he had declared that it’s still too early to draw any conclusions about the study in women, TIME went on to say (erroneously) that the “trial focused on commercial sex workers, who are at increased risk of acquiring HIV, and, says Fauci, may not be reporting their adherence to the drug regimen accurately.” (Later in the piece, the reporter attributes a more Fauci-like opinion to Fauci — that is, the suggestion that further study is needed; that we may find that there are differences we don’t yet know about, which can cause Truvada to react in men and women differently; that it could be that documentation of adherence to the medication was a missing component in the trial involving women. If, as one suspects, those last comments reflect a more accurate account of what Dr. Fauci said, he was one of the rare experts who fairly assumed that if a lack of adherence were to be found among thousands of female participants in a study, that would point to a shortcoming in the study, not in women. The International Partnership on Microbicides — perhaps not coincidentally, led by a female scientist who is both respectful toward and deeply grateful to women who volunteer for HIV trials — released the only statement AIDS-Free World could find that avoided speculation unworthy of science, and still managed to convey the details of the disappointing news as clearly as anyone else had — all without a hint of blame.

TIME, on the other hand, after going on to “report” that pregnancies that occurred during the trial among participants on birth control might suggest “discrepancy between the reported and actual use of the anti-HIV drugs,” added (as if there were one dark-horse contender among much stronger possibilities): “Aside from reporting issues, there could also be a biological explanation of why the protective effect found among gay men was not seen in women.”

Aside from reporting issues? The jury of journalists, unencumbered by evidence, appears to have beaten scientists to a verdict. Their judgment has a familiar ring to it, one we’ve heard repeatedly throughout the 30-year history of the AIDS pandemic: if women end up infected with HIV, assume it’s their own fault.

Paula Donovan Answers Infrequently Asked Questions: As We Rush Toward a Goal, Will the UN Give Us an Honest Baseline?

Tue, 12 Apr 2011 12:49:00 -0400

By Paula Donovan

On April 8^th, I dialed in to the first of two scheduled meetings (this one by phone, and the next in person a month from now) among a hastily organized “Global Task Team on Elimination of New HIV Infections Among Children by 2015 and Keeping their Mothers Alive.” UNAIDS Executive Director Michel Sidibe and PEPFAR’s Dr. Eric Goosby co-chaired the teleconference among some 50 – 60 participants, who included African Ministers of Health, the heads of WHO, UNICEF and UNFPA and the executive directors of NGOs and foundations such as Gates, CARE, the Elizabeth Glazer Pediatric AIDS Foundation and the ONE Campaign. One after another, Task Team members endorsed the goal and vowed to continue working toward it.

The premise is this: in 2009, for the first time, over half of all pregnant women with HIV received antiretrovirals to prevent transmission to their babies.

The goal: "virtual elimination" of vertical transmission to infants, and "keeping their mothers alive."

But the problem is this: that "over 50 percent" figure is a false baseline. At least a third of the "over 50 percent" received just single-dose nevirapine: far from eliminating new infections among children, it can prevent HIV transmission in less than half of all cases. And when it works, the uninfected newborns remain at risk of HIV through the breastmilk of their mothers, who haven’t been given any ARVs to reduce the HIV in their systems; 17 percent of uninfected infants will contract HIV through "mixed feeding" by mothers who haven’t been informed or supported to breastfeed safely — that is, exclusively, without any other liquid or solid for 6 months. Nevirapine is in a class of ARVs called NNRTIs; it’s an important drug when used correctly, and can be deadly when prescribed incorrectly — in single doses during childbirth. Even when that dosage works to prevent transmission, it will also cause about 30 percent of the HIV-positive women and half of the infected babies to develop resistance to nevirapine and all other NNRTIs. This means that when those mothers and babies are eventually placed on antiretroviral therapy, the most commonly used "triple combination therapies" won’t take effect, since the single dose of nevirapine they received during childbirth will have tipped off the virus, which morphed into an HIV strain that is impervious to one essential component: NNRTIs.

Yet another giant subset of the "over 50 percent of pregnant women" we’re led to believe were prevention success stories were actually “lost to follow-up”: no one has tracked them, and so we have no idea whether their babies are positive or negative. And finally, there’s the misleading tag end of the Global Task Team’s name, “and Keeping Their Mothers Alive.” The truth, buried deep in UN reports, is that most of the “over 50 percent” of HIV-positive women who were given some form of prophylaxis during 2009 to reduce the risk of transmission to their babies received no assistance at all to keep themselves alive. In fact, the vast majority were never even assessed by a medical professional to determine what kind of help they needed for their own HIV.

So, subtract from the “over 50 percent” starting point all the women and babies who received single-dose nevirapine instead of a WHO-recommended regimen and didn’t avoid transmission. Subtract all the babies who survived childbirth without infection, and then contracted HIV through mixed feeding. Subtract all the mothers who developed ARV resistance from a dangerous single dose of nevirapine; subtract all the women who weren’t given any medical attention at all for their own health, and then subtract the droves lost to follow-up. I don’t know the mathematical formula, but even without one, it’s easy to see that “over 50 percent” is not the baseline against which to measure progress toward “eliminating new HIV infections among children by 2015 and keeping their mothers alive.”

After the teleconference, I sent an email to Michel Sidibe, copied to several of his colleagues at UNAIDS who’d been present on the call. He replied today. Here’s the correspondence:

April 8, 2011

Dear Michel,

Thank you for inviting AIDS-Free World's Co-Directors to join the Global Task Team on Elimination of New HIV Infections Among Children by 2015 and Keeping their Mothers Alive. On this morning's teleconference — the first of the task team's two meetings — I asked a question about the joint WHO/UNAIDS/UNICEF yearly report, "Towards Universal Access." You indicated that questions would be answered toward the end of the teleconference, but it appears that there wasn't enough time for that. Would you be so kind as to answer the question now?

Now that single-dose nevirapine is no longer recommended by WHO, and now that WHO has acknowledged that single-dose nevirapine places women and children at risk of developing resistance to NNRTIs, will the next Towards Universal Access report provide a global percentage of progress against vertical transmission that excludes those women who received just single-dose nevirapine (sdNVP)?

Towards Universal Access: Progress report 2010 stated that "an estimated 53% of pregnant women living with HIV received antiretrovirals to reduce the risk of transmitting HIV to their infants." In the published report (but not in UN press releases or statements made to the media) that overall percentage was followed by this qualifier: "A large proportion continued to receive the less efficacious single-dose nevirapine regimen." This was two months after WHO had released its final revised recommendations on Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants and its new infant feeding guidelines, and had withdrawn its support for the use of sdNVP.

As recently as March 28, 2011, when the Secretary-General released his global progress report on HIV and AIDS, the UN was still stating that over half of all women living with HIV had received prophylaxis to prevent vertical transmission — again reporting a percentage that includes women who had received only the suboptimal, dangerous sdNVP. And as you know, countries such as Namibia are listed as having achieved the UNGASS goal of preventing vertical transmission — despite the fact that nearly half of the women reached in Namibia were given sdNVP. To count women given sdNVP among the "virtual elimination and keeping mothers alive" success stories seems especially illegitimate now, following WHO's new guidelines that advise against the use of sdNVP (and its statements yesterday, on World Health Day, about the shared responsibility at all levels, including international partners, to make every effort to prevent drug resistance.)

I would hope that when you and Eric Goosby report progress toward "Elimination of New HIV Infections Among Children by 2015 and Keeping their Mothers Alive," you will provide all those involved with an overall percentage that is a true reflection of where things stand, so that we will have an accurate baseline against which to measure progress.

But at the moment, I would very much appreciate just a quick answer to the primary question: will future UN progress reports, such as the next Towards Universal Access report, include an overall total that excludes women given sdNVP?

With thanks and best regards,

Paula

April 12, 2011

Dear Paula,

Thank you for participation in Friday’s call — it was great to have you contribute to the important kick-off for this important and time-sensitive initiative.

You are raising a critical question on the measurement of the percentage of pregnant women who received antiretrovirals to reduce the risk of transmitting HIV to their infants. This kind of comment should inform the discussion in the e-forum for the GTT. I am sharing your question with our team that will set-up this forum this week.

I am also sending your comment to Margaret Chan and the HIV team at WHO for clarification on this issue.

I look forward to your continued engagement in the GTT.

Sincerely,

Michel

Paula Donovan Answers Infrequently Asked Questions: Mass Rapes in the Congo Made the Headlines in August

Mon, 01 Nov 2010 15:52:00 -0400

By Paula Donovan

What distinguished that atrocity from the vicious, relentless rape of Congolese women throughout the conflict?

ANSWER: Media attention. That’s all.

The tragic truth is that nothing else was unusual. The UN has been failing to protect women against rape ever since peacekeeping operations were established in the Democratic Republic of the Congo. Eleven years into the $1-million-per-day mission, the UN itself describes the country as the worst place in the world to be a woman, and that’s an assessment based on details of unimaginable rapes that are sent to UN headquarters with bone-chilling regularity. But it wasn’t until August 2010 that the Secretary-General switched into emergency mode – entirely in reaction to global media reports that, unbeknownst to peacekeeping units stationed nearby, hundreds of civilians had been raped during a 4-day-long militia attack in North Kivu province’s Walikale region. Suddenly energized by public scrutiny, UN Secretary-General Ban Ki-moon first dispatched his second-ranking peacekeeping official to the area, and then sent a Special Representative (both delivered to the interior by UN helicopters that were nowhere to be seen during the militia invasions), with a list of questions falling under the heading “What went wrong?”, including:

– Are media reports true: was the UN aware that the area was under siege, and did they send text messages on the first day warning staff and NGOs to avoid the area – texts that specifically mentioned rape?

– With peacekeepers stationed in the immediate area precisely because it was a region in imminent danger, and soldiers posted within one day’s journey at most, why didn’t the UN move to protect the civilians at any time during the four-day attack?

But the most important questions – the ones that must be asked about the UN’s overall failure to fulfill its civilian protection mandate in the Congo at any time, rather than simply during this one horrible but representative case – still aren’t being asked.

During any four-day period in the DRC, an average of 184 rapes will be reported. The word “reported” cannot be over-emphasized: by all accounts, the 17,000 rapes reported in 2009 were a small fraction of the rapes committed.

The fact that the mass rapes in Walikale were designated “breaking news” by the media because they occurred en masse should be irrelevant to the UN. The attack in Walikale was not unique. The strategic use of rape by various militias terrorizing the area was not unexpected. The attacks were not more brutal or serious than the conflict-driven, strategic rapes committed every single day.

For the hundreds of thousands of eastern Congo civilians whose pasts include being raped during the tenure of the UN’s largest peacekeeping mission, the political categories of the crimes perpetrated against them don’t make a big difference. A woman brutalized on her way to the marketplace a week before the mass attack did not bleed less, suffer less, fear less or sustain less damage to her mind, body and spirit because she was alone when it happened. She will feel – and should feel – that she is also a victim of 'crimes against humanity', and as much a part of a widespread group subjected to planned, systematic sexual crimes as the villagers nearby who were raped within sight of one another and suffered en masse. She will feel – and should feel – that her own solitary ordeal, along with the ordeals of hundreds of thousands raped before her, and the constant terror experienced by all who live in wait should have spurred the UN to send high-ranking officials to ask their investigative questions long ago: What is going wrong? Where are we failing? How can we prevent more rapes?

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