September 2009 Archives

I have a bit of a bee in my bonnet this morning. The New York Times had the following sentence in an article on the Pope's European tour: ''The Pope came to this decidedly skeptical nation (The Czech Republic) as part of a Continentwide mission to urge the nonbelieving out of their collective apathy".

To be a non-believer or skeptic in a world dominated by faith is not to be apathetic. It takes a courage of convictions to embrace reason in the face of world where to question a person's faith is akin to calling their Mother a bad name.

A recent poll, widely reported in the media, found that atheists and non-believers are considered amoral and wicked. The study asked the question, "This group does not at all agree with my vision of American society," about every major religious group and ethnic group, as well as recent immigrants and of course of atheists.

Atheists won the most reviled award.

Why is it that it is verboten to question virtually any aspect of someone's faith, but is fine to criticize the lack of faith? I am used to being out of the mainstream and I don't need the warm embrace afforded to the in-groups of the world.  You can have your stories, I'll take mine. But if you are a so-called 'person of faith' ask yourself why so many of your compatriots think I am wicked and amoral for opting out of your hegemony.

The good works of churches and other faith-based institutions in combating the AIDS epidemic is commonly reported, and rightly so. What about the great works of the non-believers? Every survey of scientists finds the vast majority are atheists. That means the pills that keep us alive, the lab tests that monitor our health, the studies that detail the dizzying complexities of our pandemic, not to mention the vaccines and cures that are being worked on- those are all the works of the reason-based community, of the non-believers.

We are a mostly-quiet and growing minority. We are far from apathetic. Every non-believer faces a moment, or more likely moments when we actively choose to reject what we have been told, and embrace what we have learned. To do so takes bravery- we know our lack of faith is fair fodder for dismissiveness and hostility.

We swim against a mighty tide, and do so at our own peril. We are not apathetic. We are, each of us in some way activists.

 

What in the world to write about today? The 'Vaccine Breakthrough'? Abbott? The Fires of Montana? The Yankees? The Pope and Science? 

The world has provided me an embarrassment of riches to e-scrawl my thought on. Being more of a 'both/and' than 'either/or' person, my thought is to embrace the deluge and hold forth on it all.

Topic 1: The "Vaccine Breakthrough"

The Story: This past week the mainstream media was filled with almost breathless stories on reports of a major breakthrough in the struggle to develop a vaccine against HIV. Researchers had announced results from a trail of a prime-boost combination of two failed vaccine candidates, and found an approximately  one-third reduction in infections.

My Take: Be skeptical. Be very, very skeptical. The minute I read this story with my first cup of coffee on Thursday, a gnawing sense of déjà vu crept in. The 2 vaccines in question- ALVAC and AIDSVAX, have been tested before with quite poor results. Moreover, in the AIDSVAX case, the developers engaged in some highly unethical shenanigans- attempting to spin their full-bore failure, into a unsupportable partial success.

The vaccines in question had been fairly extensively studied previously and showed no protective effect whatsoever. While it is conceivable that combining two ineffective vaccines could be combined to make a marginally successful one, it is unlikely. As veteran AIDS activist Gregg Gonsalvez  was quoted as saying in the New York Times, 'two duds don't make a firecracker'.

The data, such as we have seen aren't exactly spectacular. The study followed over 16,000 Thais: half getting a 2-stage vaccine (called a prime-boost) and half a placebo. Everyone was given condoms and counseled about safe sex. At the end of the trail there were 51 new HIV infections among people in the vaccine arm, compared to 74 in the placebo group- or a 31% reduction in infections.

While on the surface this modestly positive result looks good- like something researchers could build on to create a more broadly protective vaccine, a close look at the limited data available to us gives me much less hope.

I am skeptical for two reasons. First these results are barely- and I do mean barely statistically significant. Second, as mentioned previously there is a history with one of the 2 vaccines used in the study of unethical data spinning.

What do I mean by 'barely statistically significant'? In research, it is understood that a single study can only provide a best estimate. There is always an element of chance involved. To account for this, statisticians use something called a 'confidence interval'- which basically provides an upper and lower range (or bound) where we have a 95% degree of confidence the real results lie within. If the lower part of that interval is at or below 1, the results are not significant- that is there is enough possibility they are from chance, they cannot be counted on. In this study the lower bound of the confidence interval is 1.1%, meaning that just a handful more infections in the vaccine group, or fewer in the placebo group would have rendered the results non-significant.

Moreover, the people developing one of these two vaccines- the AIDSVAX- have a sketchy history. In an earlier study of their vaccine, they attempted to spin the overall negative results from their study, by engaging in a bit of data mining. Data mining is when you crunch the numbers from a study over and over, looking for something positive. In this case, they claimed that while their vaccine failed to protect the overall study group, it seemed to work quite well in people of African and Asian ancestry.

The problem was there simply were close to enough people of African or Asian ancestry to make such a claim. This led to wider than wide confidence intervals, not even close to statistically significant. Looking more closely at the results among African Americans, they hinged on just a handful of fewer infections at one study site (Chicago if I remember correctly). While I can wrap my head around the notion of a vaccine working differently in people of different ethnic groups, I cannot imagine a vaccine working differently in African Americans from Chicago compared to those in Los Angeles.

I hope this result is real- we need something positive to build on. Let's just stay I am not confident.

Story 2: Abbott buys Solvay.

My Take: Abbott, the makers of Kaletra and Norvir- along with a bevy of other drugs- are buying Solvay Pharmaceuticals- the makers of Marinol among others. This is bad news on two levels. First, Abbott are the worst or the worst in the rouge's gallery of big Pharma. Their behavior towards people with HIV and the activist community is abhorrent. Anything that makes Abbott bigger, and increases their reach in HIV is bad news.

Bore broadly though, this is another step in the consolidation of the industry. Fewer and fewer players in the pharmaceutical industry is bad news for people with HIV- for people in general.

Boo to Abbott. Boo to corporate consolidation.

Story 3: The Fires of Montana.

My Take: I just got back from my latest trip to Montana. I have written before about my love for my adopted third home Montana. This latest trip was, well a trip- as we spent the whole weekend under an evacuation warning due to a near by wild fire. As we approached the bucolic beauty of the Feather Pipe Ranch outside of Helena, a tower of dark smoke rose from a near-by mountaintop. As we drove closer, we could see flames and ash began falling from the sky.

The fire stayed far enough away that we didn't need to skedaddle.  The people of the FDH and Associates, and the Montana Gay Men's Task Force deserve so much praise for the great work they do on behalf of people living with HIV in Montana. The weekend was filled with workshops, community building and fun. I am always impressed by the quality of the presentations and the sense of togetherness I experience when I fly in those little puddle jumper airplanes to the great state of Montana.

Story 4: The Yankees.

My Take: I am a huge New York Yankees fan. Yesterday, as I soared through the clouds somewhere between Salt Lake City and Oakland, the Yankees won their division, and secured home field advantage throughout the playoffs. The proverbial icing on this delicious cake was they did it by sweeping the hated Red Sox in the Bronx. I come from a family evenly divided between Yankees and Red Sox fans. I am resisting the urge to call my Red Sox loving father and gloat today. I am evil. I know.

This season has had a special feel to it. After struggling a bit in the first few weeks of the year, the 26 time world champs have player remarkably consistently great baseball since May. After dropping the first 8 games of the season versus the Sox, the Yanks won 9 of the last 10 to split the season series. Back in June I told my roommate- a life long baseball fan and Yankees hater- that whatever happened this year, I liked this year's Yankees. They had the feel of a good team. While the last few years have seen early playoff exits (or last year no playoffs at all), I like our chances this year.

Story 5: Last but not least the Pope and Science

My Take:

Pope Ratzinger- or Benedict- gave a speech in the Czech Republic warning of the dangers of secularism and calling for a repair of the rift between science and religion. I am a cultural Catholic and a committed atheist. Being scolded by the former Hitler Youth Pope about the dangers of non-belief, is, well beyond belief. The science thing is especially galling. The rift between science and religion is 1) largely beyond repair and 2) mostly the product of the repression of science by religion. Religion is at war with Science. From Copernicus and Galileo to attempts to force the anti-science of 'intelligent design' into science classes the forces of faith have long worked to silence free scientific inquiry. Where has science sought to suppress faith? Where? Unbelievable. 

Today's New York Times has an interesting article about Dr. Richard Pazdur, the FDA's cancer guy. If you get a chance to check it out. It brings up a few interesting issues that drug companies, advocates, regulators and patients face when dealing with drug development for serious illnesses.

What struck me most from this story is how good we have it in HIV. Through many types of dogged activism, we ended up with a system where, for the most part, the right drugs get approved in a timely fashion. We have validated surrogate markers, bright and dedicated community activists and a track record of success.

How different it could have been. What would the world be like had the FDA remained unmoved, unchanged by the early AIDS activists? Without parallel track, expanded access, accelerated approval, CABs- where would we be.

The business of drug approval is fraught with competing interests. Drug companies want their drug approved. Patients and advocates struggle with the desire for new drugs against the realities of toxicities and side effects. Regulators have to shepherd the process, balancing the desire for new treatments against the many vagaries of biomedical research.

AZT was approved based on its ability to extend lives by a matter of weeks. The first combination therapies- dual nucleosides (d4T plus 3TC for example), were used because the could be shown to slow the rate of immune decline. Three drug therapy- or HAART as it has become known- showed the potential to reverse HIV disease progression.

In the early days, it was a given that the drugs would make you sick. The main question was would they give you more life. Now, it is pretty much a given that new HIV drugs will 'work'- they will reduce HIV levels, improve or stabilize CD4 counts- and mostly we argue over tolerability and durability.

I am not familiar enough with the state of cancer research to have opinions on their drug development process. This article makes it clear there is still a lack of agreement on how these drugs should be studied and evaluated.

Cancer is the second leading killer in the US- behind only heart disease. Most research shows that people with HIV are at a higher risk of cancer overall, in addition to being at specific risk for HIV associated cancers like KS, and lymphomas. In short we have a dog in this fight.

Speaking of dogs and cancer- it is the 40^th anniversary of the declaration of the war on cancer, and the 40^th anniversary of Scooby Doo. How little both have changed over this time.