Monthly Archives: March 2007

Of men and monkeys

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I realize that my previous blog entry makes it sound as if HIV researchers are a complaining and bitter bunch. Far from it. They do complain, but they are also one of the friendliest and most unpretentious group of researchers anywhere. They can go from discussing how quickly HIV can wipe out the immune system to the latest in footwear and eyewear in a flash.

Last night was the finale of the HIV meeting — and may I just say, these scientists also know how to party.

Earlier in the week, bigwig HIV researcher Bruce Walker hosted his annual keystone bash. Here are a few things that should tell you it was a great party: there was much spilled drink; people sang Happy Birthday to Philip Goulder at midnight (it really was his birthday); everyone with a camera or cellphone snapped incriminating pictures of everyone else; one noted scientist was so falling down drunk that he really did fall down and had to be escorted home; and the police came — twice.

Last night’s was almost a repeat performance, but the police didn’t make an appearance — not that I know of anyway. In between their drunken revelry, these scientists also managed to put on one of the most interesting conferences I’ve ever been to. As per keystone rules, I can’t really write about the specifics, but among the topics I found most interesting were those that delved into why sooty mangabey monkeys infected with SIV, the monkey version of HIV, never progress to a disease like AIDS and on elite controllers, a group of people who, despite being infected with HIV for more than a decade, have undetectable levels of the virus in their blood.

Figuring out what protects the monkeys or the elite controllers could be the key to a good vaccine. And this week’s talks made me feel optimistic that at some point in my lifetime, even if not in the next 15 or 20 years, we’ll know the answer.

Whither the big cheese?

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Straight from the TB meeting last week, I’ve been at a HIV keystone meeting all week that has two parallel tracks — one focusing on the molecular aspects of the disease and the other on strategies for making a vaccine.

The big question on everyone’s lips is, why is no one from the biggest HIV vaccine project here?

In 2005, NIH created CHAVI, a $350 million behemoth led by a small group of scientists. With that kind of money at stake, particularly at a time when funding is tight, many scientists were understandably outraged — so much so that it seemed like it might split the field into bitter, warring factions.

This meeting tells me that sadly, it already has.

Last year, we reported researchers’ fears that CHAVI was cutting into individual grants. Two years into CHAVI almost no one, including some people at the NIH, has anything good to say about it. The project has already taken up about $70 million, and judging by CHAVI leader Bart Haynes’ presentation yesterday, doesn’t have much that’s new to show for it. Haynes says most of the first year went toward setting up collaborations and infrastructure — and that may be true. But why isn’t his team here to share what they’re doing with the rest of the field? Even Haynes flew in just for his talk and flew back the same night, which didn’t really give people much time to interact with him or ask questions.

The coffee breaks are rife with rumors that even though four fabulous teams applied for the CHAVI grant, the NIH had decided months before who they would give the grant to — and that the decision was entirely political. People are also saying that any project grant that competes with CHAVI’s domain automatically gets rejected.

This being a particularly gossipy community, there’s little proof of any of this — grants may be getting rejected simply because these are tough times, for example — but it almost doesn’t matter whether it’s true. The point is, many of the scientists here are feeling betrayed by the NIH’s decision to fund CHAVI and worse, afraid of what they see as its favoritism.

This cannot be good for the field. Far as I can see, if the NIH doesn’t soon make an effort to be more open — and more inclusive — about what CHAVI is doing, this important field will split into the CHAVits and the CHAV-nots.

TB’s day in the sun

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Well, sort of. For the past few days, I’ve been in rainy Vancouver, where TB researchers from all over the world have gathered for a Keystone meeting on the topic. As we reported in our free TB special this month, TB kills 4,400 people every day and together with HIV, is creating a serious crisis in Africa, Asia and eastern Europe.

Not that you would know it from the WHO’s press release on the occasion of World TB Day (today, although the release came out Thursday). The WHO takes a self-congratulatory tone, announcing that TB has leveled off for the first time since 1993. It’s not until the third para that you find out in actual numbers, TB continued to rise in 2005, just more slowly than it had in 2004. That’s worth trumpeting?

TB scientists complain that one of their biggest obstacles is the abysmal funding, about a tenth of the money available for research on HIV/AIDS. It seems to me that the WHO’s positive spin is going to make donors even less likely to chip in. I don’t doubt that the situation could be worse, but when a disease kills nearly 2 million people a year, that’s no time for pats on the back.

A few scientists at the meeting have said that they find the WHO’s stance unhelpful and demoralizing. Fortunately, it dosn’t seem to be affecting their research too much. This is my first TB keystone meeting, but people here have been marveling at how well attended it is this year.

Even better, many of the attendees are young grad students and postdocs. After decades of no drugs, no vaccines and absolutely no money, TB is making a comeback. You could almost say that attention from celebrities like Angelina Jolie and Bono has made TB sort of… sexy.

As offensive as that might sound, anything that brings this horrible killer more attention is all right with me. I’m heading back now to hear more about clinical trials for new TB vaccines, the first good candidates to be tested in almost a 100 years.

Harmonizing conflict

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Conflict of Interest is a touchy matter. Just crack open the pages of Nature Medicine and you’ll see that scientists who publish topnotch research regularly declare financial conflicts. It’s a fact that drug companies seek out the best physician-scientists—and so do agencies in need independent scientific advice, such as the US Food and Drug Administration (FDA).

So what to think of the new FDA proposal limiting conflict of interest on its advisory panels? The proposal would prevent researchers from serving on panels if they receive more than $50,000 from a company or competitor whose product is being discussed. Those who receive less than that amount can participate in the committee but cannot vote.

The agency is in a tough position: it’s been slammed repeatedly over lax conflict of interest rules. Yet agency officials are right when they say that the best advisors may often have financial conflicts.

The Institute of Medicine recognized this dilemma in its recommendations for FDA reform last fall. They recommended capping the percentage of individuals with a ‘significant’ financial conflict of interest at 60 percent.

The proposed guidelines seem to follow the spirit, if not the letter, of this recommendation. It’s possible the guidelines go too far—considering that it seems that no one with any conflict whatsoever can vote—or that the guidelines will lose their teeth after the 60 day comment period. For a breakdown of the pros and cons, see Derek Lowe’s blog “In the pipeline.”

Either way, it’s good to see the FDA is responding to legitimate criticism of its current system, as well as threats from Congress to impose more draconian conflict of interest rules through legislation.

Stem cell rebel

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Let’s hear it for Elias Zerhouni, director of the National Institutes of Health. He came out strongly in support of stem cell research at a Senate hearing this Monday, bucking the official line of the Bush administration.

“It is in the best interests of our scientists, our science, our country,” he said, “that the nation finds a way to allow the science to go full speed on both adult and embryonic stem cell research.” Zerhouni also denounced the notion that adult stem cells hold just as much promise as embryonic stem cells.

Whether the NIH director is being flogged right now in a back room at the White House is unclear. But administration officials were quick to try and repair the damage. “There was only one moral line the President said that he would not cross," said a White House spokesperson, "and that is that federal taxpayer dollars should not be used in the destruction of embryos.”

A few years ago, when stem cells seemed the biggest thing on the President’s agenda, Zerhouni’s statement might have caused a massive uproar. But now it seems that it’s getting lost in all the other dramas going on, from the Scooter Libby trial to the Supreme Court case on “Bong hits 4 Jesus.” Maybe, just maybe, there’s change—or at least rebellion—brewing on the stem cell front. I don’t know about you, but I’m looking forward to what happens next.

The ABCs of Bush’s agenda

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By now, there’s mountains of depressing evidence that in the Bush administration, ideology always trumps science.

Nowhere does this seem more cruelly short-sighted than in the administration’s approach to AIDS. I’ve written here before about the government’s insistence that any groups that receive federal funds have to formally oppose prostitution.

Here’s one more disheartening report: after a year-long investigation, the Center for Public Integrity, a nonprofit based in Washington DC, has found that PEPFAR, the administration’s $15 billion AIDS initiative, “has not worked out the way it was envisioned.”

One of PEPFAR’s most criticized aspects is the ABC approach for prevention: abstinence, be faithful and condoms. Neither abstinence nor being faithful is much of an option for a married woman whose husband is unfaithful, but let’s not get bogged down by practical details.

The center’s Consortium of Investigative Journalists filed two dozen Freedom of Information Act requests, FOIA lawsuits against the State Department, the U.S. Agency for International Development and the Department of Health and Human Services. After more than 100 interviews, examination of thousands of pages of documents and reporting on the ground in affected countries, they say that:

In fact, the actual prevention practices stress the “AB” messages — abstinence until marriage and being faithful to one partner. The “C” has moved to a small c, and the use of condoms is lumped into the category of “other preventions” that includes prevention of mother-to-child transmission, blood safety, safe medical injections and control of intravenous drug use.

It’s nice to see that tomorrow, this ambitious project, dubbed “”https://www.publicintegrity.org/aids/“>Divine intervention”, is set to win the first prize in online and trade journals category from the Association of Health Care Journalists.

On another positive note, I mentioned before that Brazil had turned down money from the US rather than meet the ideological demands. Looks like even within this country, there’s some rebellion afoot.

On March 5, Wisconsin turned down about $600,000 in federal “abstinence-only-before-marriage” funds because the money would have prevented programs from teaching kids about contraception or sexually transmitted diseases. California, Maine, New Jersey and Pennsylvania have also turned down the funds and another dozen are set to do the same, according to Madison’s The Capital Times

Sitting on a drug’s deadly effects

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People being treated for cancer often become anemic, meaning their blood oxygen levels fall too low, which is partly why they feel exhausted during treatment. To ease the anemia — and the fatigue — doctors prescribe erythropoietins, which stimulate the production of red blood cells.

On Friday, the Food and Drug Administration warned that these drugs, sold under the brand names Epogen, Procrit and Aranesp, are doing more harm than good in some cases. Doctors have apparently been over-prescribing the drugs, using them to reverse anemia, instead of just alleviating it enough to avoid blood transfusions.

The agency says that the drugs carry a higher risk of blood clots in the legs and the lungs, could make tumors grow faster, and could even cause people being treated for cancer to die more quickly. The drugs will now be sold with a black-box warning that highlights these risks.

Here’s what I don’t understand: we first reported on the risks with these drugs in 2003, when a couple of trials unexpectedly showed that people taking erythropoietin died faster than those taking the placebo.

We quoted experts who had found that many tumor cells have receptors for erythropoietin and that the cells grow faster in response to erythropoietin, and we reported — perhaps naively, in retrospect — that the mounting evidence might have an effect on how the drugs are prescribed.

As I said, that was in December 2003, more than three years ago.

Why has it taken so long for the FDA to act?

Big bucks — but what’s the payoff?

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The Stanley Medical Research Institute, a Maryland-based philanthropy, is donating $100 million to uncover the genes important in mental illnesses such as bipolar disorder and schizophrenia, according to an article in today’s Boston Globe.

The money is going to the Broad Institute, led by genome bigwig Eric Lander, who was one of the driving forces behind the cancer genome. I’ve already noted the criticisms against that project, and some of the same apply here. Sure, technology now allows us to find the genetic variations between different people and the researchers will no doubt find masses of data.

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But these are extremely complex disorders, each involving multiple genes. What roles do those genes play in the disease? Without understanding how the different genes interact and what the impact is of the different variations, the data will be all but meaningless. For example, scientists from the cancer genome project are reporting in this week’s Nature that the number of mutations that drive cancer is much larger than they expected.

To the institute’s credit, the mental illness project’s results will be publicly available — the more scientists who can analyze the data the better. Lander is quoted in the Globe as saying, “If you’re looking for a needle in a haystack, and you can sift the whole haystack, you’ll find the needle.”

Hmmm…. I don’t think that was the message of the idiom.

Denying AIDS

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My New Yorker mag arrived Monday with an article about a topic that’s all too familiar to us, here at Nature Medicine. Science reporter Michael Specter wrote about AIDS denialists — or dissenters as they like to call themselves — who say either that HIV does not cause AIDS or that antiretroviral drugs do more harm than good, and that most scientists are in the pockets of the pharmaceutical industry. That last bit may be debatable, but to us and to everyone we consider credible, there’s no doubt that HIV causes AIDS or that antiretroviral drugs are safe.

I’m happy the New Yorker gave this urgent and deeply troubling issue some much-needed attention, but I’m a bit disappointed with its tepid tone. If you get through the whole article — and I suppose many of the magazine’s readers do — you come away with the feeling that the denialists are certainly wrong. But the first few pages give so much space to Peter Duesberg, the most famous denialist, and to the potential benefits of South Africa’s traditional medicines that you might almost be tempted to think these people have a fair point. After all, who among us hasn’t thought that scientists can be too harsh on those who don’t agree with the reigning hypothesis or that they don’t pay enough attention to traditional therapies?

But this is not your average scientific disagreement. There is NO question that HIV causes AIDS and to follow the “he said-she said” school of journalism in this case, strikes me as tame and… well, I’ll leave it there. I hope the New Yorker piece goes some way to repairing the damage caused last year by an article in Harper’s by dissenter Celia Farber.

For our part, we’ve covered the resurgence of denialists and the activities, in particular, of one Matthias Rath, who markets multivitamins as a cure for AIDS. Scientists and AIDS activists have sued the South African government and Rath for conducting trials of the so-called vitamin cures.

These denialists like to distort scientists’ own statements to support their theories and have even misappropriated sentences from one of our scientific reports, which we explicitly countered in an editorial last year after the Harper’s piece appeared. And we hope more of the mainstream press steps up to cover this issue.

Update: We have decided not to accept any more comments on this post, as the discussion between the two camps is not productive. We don’t want this blog to perpetuate a discussion that has already received too much attention

People not cattle

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What are FDA officials thinking?

The FDA is poised to approve a front-line antibiotic used for mengingitis and other human infections for use in cattle, according to a report in Sunday’s Washington Post. Approval of the antibiotic could lead to antibiotic resistance developing in animals, and then spreading to people.

Apparently the agency is not thinking; it seems instead to be following a ‘guidance document’.

And that document goes against the advice of the agency’s own scientific experts, the American Medical Association and about a dozen other health groups.

These health groups point to evidence that antibiotic use in animals is linked to the development of antibiotic resistance in the human population. In fact, an FDA advisory committee voted 6 to 4 against approving animal use of the antibiotic, cefquinome, a fourth-generation cephalosporin.

Nonetheless, Stephen Sundloff, the head of the FDA’s Veterinary Medicine Center, told panel members that their vote was “not binding”. Instead, he told the committee that the FDA was bound by “Guidance for Industry #152” which limits bans on antibiotic use in animals; the details are a bit mind-numbing but it seems that it’s only easy to ban an antibiotic for animal use if the drug threatens treatments for food-borne illnesses.

That’s way too narrow a definition, given the ability of bacteria to exchange resistance genes. Let’s hope that, in the end, the FDA is able to make a common-sense and scientifically sound decision.