February 2009 Archives

Tucked away in the massive stimulus package signed by President Obama last week is the largest budget increase in the NIH's history. Thanks to Senator Arlen Specter, the budget of the National Institutes of Health will go from $29 billion to $39 billion -- a whopping 34 percent increase (see this NYT story for details).

I called Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and the top federal official responsible for AIDS research, and asked him how much of this increase would go to AIDS. Short answer, we don't know the exact amount at this point, but it should get approximately the same boost as all the other research areas. The current AIDS research budget is $2.9 billion. That could go up by another $1 billion, give or take a couple hundred grand. That's some serious stimulus.

Here's how it will work. The NIH will get an additional $10 billion, which it has to spend within two years. About a quarter of this amount is to be spent on classic infrastructure projects, like new buildings and laboratories at the NIH and university campuses. $7.4 billion will go directly to research, paying for as many as 15,000 additional grants submitted by scientists at universities across the country.

Each NIH institute will get a share of this $7.4 billion equal to their current allocation of the NIH grants budget. Then it will be up to each institute how to allocate their share. Fauci and the other institute directors will need to scour their current grant programs to find projects that can be funded quickly (within the next two years). They'll do a combination of new grants and increasing the size of some current grants. For new grants, they'll first look at recently submitted grant requests that were scored as worthy of support, but fell just below the previous budget cut-off lines.

So as each institute director looks at their current and potential grants portfolio for AIDS (there is no AIDS institute, but NIAID does more AIDS research than all the others), they'll be looking for what they can fund quickly, or within two years. If their AIDS portfolios offer lots of quick funding options, we'll get our fair share of the new stimulus money.

Fauci was hopeful that AIDS research would get the approximately one-third increase that other disease groups are hoping for. That would mean about $1 billion more over the next two years. That's huge. Combine this with some new found energy among activists and researchers to actually figure out a "functional cure" for AIDS, and we could be entering a golden age of AIDS research.

Is Crystal Uncool? Gay Men’s Love Affair With Tina May Be O-Vah
by Scott Stiffler
EDGE Contributor
Tuesday Feb 17, 2009

Stiffler asks the following questions:

But how much is tina use ebbing among the affluent gay men who were at the forefront of the epidemic--and, not incidentally, have been at the forefront of efforts to stop its rampant use? Anecdotal evidence points to programs that began with activist Peter Staley’s bus and telephone-kiosk ads in New York City’s Chelsea and Hell’s Kitchen neighborhoods as making tina uncool (or at least less cool). But how effective have they been?

Good questions. I actually have no idea what the answers are, and am interested in what others think, so post your thoughts below.

Why am I clueless on this? Stiffler nails it by pointing out that "A lack of reliable data has complicated any tracking of what is generally acknowledged as an epidemic."

I've got only one quibble with his article. Stiffler states:

There is a general consensus among those working with gay men that harm reduction, not abstinence, is a far more effective technique. "Harm reduction" is a controversial umbrella term for programs that don’t tell the user to quit entirely. Instead, they encourage cutting back or limiting to certain times or experiences and not using at other times; or at least using less.

Actually, there's no consensus on this, either way. I'm actually for both. Any strong communal response most offer both abstinence and harm reduction programs and messages. I still don't see the conflict in attempting to reset social norms in the gay community by honestly condemning what meth is doing to us, while offering both harm reduction and abstinence programs to those seeking help. Call it the New York City approach.

I do worry about cities where harm reductionists have completely suppressed any and all social marketing campaigns that tell the truth about how destructive meth can be (call it the Seattle approach). If no one is allowed to say crystal is uncool, will we ultimately reduce its harm?

As I mentioned last month, Gilead has an experimental pharmacokinetic (PK) enhancer in development that does the same thing as Norvir, Abbott's overpriced "booster" which most of us take to increase the blood levels of our protease inhibitors. We first heard they were studying the new booster, called GS-9350, as part of a possible 4-drugs-in-1 combo pill that would potentially supplant Atripla as the antiviral regimen du jour.

AIDS activists have been begging Gilead to study a stand-alone version of this booster with currently marketed protease inhibitors as well, offering the first potential competition to Norvir. Yesterday, at the CROI conference in Montreal, Gilead announced just that (see their full press release), saying they are "examining GS 9350’s potential to boost HIV protease inhibitors, which are used in many HIV treatment regimens. Gilead has initiated a pharmacokinetic study of GS 9350 that will assess its ability to boost atazanavir, one of the most widely prescribed HIV protease inhibitors."

Besides its exorbitant price, Norvir has some other issues which Gilead hopes to exploit. As AIDSmeds reported yesterday, Norvir is "associated with side effects such as gastrointestinal problems and lipid increases, and may contribute to the emergence of drug-resistant virus due to the fact that it does have anti-HIV activity even at low doses. In turn, pharmaceutical companies have been eager to develop a safe and effective PK booster, without activity against HIV, that can be used in place of Norvir."

GS-9350 has no anti-HIV activity, so it won't cause resistance. And thus far, it's showing none of Norvir's side effects.

Even better news -- while these two pharma Goliaths prepare for a PK face-off, a little David called Sequoia Pharmaceuticals might muscle its way in with their own experimental booster, SPI-452 (see the AIDSmeds story). In fact, they've already tested it successfully with Reyataz, Prezista and Invirase.

Expect to see one or both of these boosters on the market in about two years. I'm looking forward to throwing out my last bottle of Norvir.

I've been meaning to post this since it ran on MSNBC on January 30th. It's not every day that a leading television journalist pays tribute to an AIDS treatment activist, so it was wonderful hearing Rachel Maddow spend two and a half minutes telling her audience about the life and work of Martin Delaney, the founder of Project Inform (see my posts about Marty here and here).

Her tribute starts at about the 1:50 mark in this section of her show:

The history of AIDS activism in the U.S. has been a mix of great success and great failure. Activism forced presidents and congress to dramatically increase AIDS research funding, resulting in the life-saving treatments we have today. But when it came to preventing new infections, we've failed miserably. As I've written about before, we've never really focused as a nation on reducing the spread of HIV. Our efforts in this regard have always been half-assed.

Activists were partly to blame. In the early years, we focused mostly on "drugs into bodies" – treatment activism. Besides, once it was confirmed that a virus was killing us, and everyone started attending weekly funerals, prevention kind of took care of itself. It was the birth of "safe sex" – no government program needed – and it worked dramatically to reduce HIV infections.

But once the funerals stopped, so did our collective fear-based response. In its place, we could have made a serious effort to prevent new infections using more traditional science-based disease prevention programs. There are dozens of community interventions that have been shown to reduce infections (the CDC currently lists 57 programs that it believes have worked), but we've never had the leadership or resources to implement a science-based national HIV prevention strategy.

President Obama is committed to launching a national strategy to fight the spread of HIV (at least he says he is, even on the White House website). But he's got a problem. Such a strategy would largely be run by the CDC. In my adult lifetime, I've never witnessed proactive CDC leadership. They're great at reacting to the latest outbreak of some scary bug we've never heard of before, but if that bug becomes entrenched and involves sex, the CDC gets very cold feet.

In short, they have never had an Anthony Fauci at the helm (the man behind our government's AIDS research programs, and the driving force that created PEPFAR, saving millions of lives worldwide). Imagine what ambitious, science-driven leadership at the CDC could accomplish in the fight against HIV.

I'm imagining it now that Obama is president, especially since it was reported that Dr. Thomas R. Frieden, New York City’s health commissioner, was one of the candidates being considered to run the CDC. What a brilliant and exciting choice he would be.

Frieden is considered by many to be the most proactive, life-saving health commissioner in New York City's history. He's successfully pushed science-based policies, even when they had substantial political resistance. This was the guy that single-handedly banned cigarettes from enclosed work spaces in New York, including our bars, leading to a dramatic drop in smoking rates (and a measurable drop in smoking-related deaths). His HIV prevention efforts have included giving away millions of NYC-branded condoms, expanded needle exchange programs, and targeted HIV testing initiatives (the largest, called The Bronx Knows, was launched last year).

Sadly, according to the New York Times City Room Blog, a single but powerful New York-based AIDS organization has come out publicly against a possible Frieden appointment to head the CDC. Charles King, the president and chief executive of Housing Works, said in a statement:

Appointing Commissioner Frieden to the top post at the CDC would be a devastating blow to combating HIV/AIDS in the U.S. as well as other chronic illnesses that require complex public health solutions and involvement from local communities. Throughout his tenure as New York City Health Commissioner, Frieden has simultaneously employed an authoritarian, my-way-or-the-highway approach and an unabashed secretiveness undignified of a public servant. He has excluded AIDS groups wherever possible from having input into life-and-death AIDS funding, testing and care policymaking decisions.

I almost snotted out my morning tea when I read this, because as almost every New York City AIDS activist will tell you off the record, Housing Works only operates on one level – "my-way-or-the-highway."

Don't get me wrong – I've long admired Housing Works. They are very aggressive advocates for people living with HIV. But I also know they are very old-school, always-hate-The-Man activists. Obama-esque, they are not. The only health commissioner (or mayor) they will ever get along with would have to be Charles King himself, and even that honeymoon would be short.

Let's hope Obama doesn't make the same mistake he just made with the PEPFAR's Mark Dybul (see the San Francisco Chronicle's "A bad start on AIDS") – listening to one or two loud naysayers that don't, by a long shot, represent the consensus view, even among activists, of the man in question. Let's hope the Obama folks read the responses in the City Room Blog from other New York-based AIDS organizations, advocates and researchers who sing Frieden's praises. Let's hope they pick up the phone and ask respected heavy-weights like amfAR's Mathilde Krim what she thinks of about the possibility of Frieden running the CDC.

When it comes to HIV prevention efforts in this country, it's time for change we can believe in.