However, in science, accuracy and precision count. I was recently interviewed for some of my thoughts on HSV-2 vaccines by Science.mic, and that article was published on February 11. I did not proofread the article prior to its publication, and thus several errors were incorporated. I address a few of those errors and omissions here.
First and foremost, it would be both egotistical and inaccurate to suggest that I am the only person capable of advancing a safe and effective HSV-2 vaccine into human clinical practice. I am offering my thoughts on the matter for my scientific and clinical colleagues to consider, and I use very plain words in explaining my rationale. However, as the saying goes, I am standing on the shoulders of giants. I did not discover the atom nor did I unlock the secrets of the universe. In general, I am stating the obvious….perhaps we should consider a live-attenuated HSV-2 vaccine because historically (as in dating back 215 years), live and appropriately-attenuated viral vaccines have prevented a lot of human disease. I am just a scientist….not the best, not the brightest, but capable enough, and I am doing what scientists do. I am advancing an argument that I believe merits a bit more attention; namely, a live-attenuated HSV-2 vaccine. And the reason I am suggesting it merits attention is because this possibility remains largely unexplored in human clinical trials and could yield something the world really needs…….a safe and effective HSV-2 vaccine.
Second, I am portrayed as going rogue. Sarah Palin is going rogue and she can see Russia from her house. I cannot see Russia from my house, nor am I going rogue. I am unafraid and unashamed to state the truth that (1) we have never tested a live HSV-2 vaccine in a human clinical trial in the U.S. and (2) I think one of the biggest mistakes a scientist can make is to not explore a potential path of discovery because he or she “knows nothing good lies down that path.” It is always possible that nothing good lies down a path of inquiry, but you have to be willing to first explore the path before you can substantiate your suspicion. To altogether dismiss a path of scientific inquiry based purely on pre-conceived ideas and conjecture is one of the single biggest mistakes a scientist can make. And this, I believe, lies at the root of why a live-attenuated HSV-2 vaccine has not been studied more carefully; this path has been dismissed as “not good” and even “dangerous,” but neither claim is supported by hard evidence.
Third, I cannot say that my goal in life is to “stick it to the FDA.” Rather, my goal with my lab’s live-attenuated HSV-2 vaccine work is to remind the world that biomedical researchers, rather than attorneys, are in a more informed position to make rational decisions about vaccine development policy around the globe. However, I note that for the past 30 years, it seems that this endeavor has been taken over more and more by attorneys who are risk-adverse. So, in the past 30 years, we have not seriously tested a (1) live-attenuated HIV vaccine, (2) a live-attenuated Mycobacterium tuberculosis vaccine, (3) a live-attenuated malaria (Plasmodium) vaccine, or (4) a live-attenuated HSV-2 vaccine. The reason why…..these vaccine approaches entail “risk,” which any scientist would acknowledge is true.
When attorneys and people who are uber-mindful of liability hear the word “risk,” this term somehow gets mentally translated into “dangerous.” As a scientist, I think that this is complete rubbish, and I think the practice of conflating the terms “risk” and “danger” is a ridiculous load of malarkey that I am tired of even pretending is real or worth giving the time of day. Every person should feel free to adopt irrational and erroneous viewpoints…..it’s a free country. I just don’t think that the USA’s national strategy to develop new vaccines should be based on irrational and erroneous viewpoints. I elaborate, as follows.
When one walks out their door in the morning, there is a risk they will die. Now, how many people in the world would choose to spend the rest of their lives as shut-ins to avoid the risks of day-to-day life? In my estimation, this would not be a particularly rational choice as having quality of life (i.e., going to work, dinner and drinks with friends and colleagues) requires that we take that risk and walk out our front door. So, yes, all human activities have risks. The trick is to weigh the “potential risk” relative to the “potential benefits.” In science, medicine, and all spheres of human endeavor, this is called “relative risk,” where we weigh the small risk of walking out our front doors versus the obvious benefits of enjoying our lives. Breathing is good…..having dinner and drinks with friends is fun. For me, I choose to partake in the benefits of dinner and drinks even though there is risk I will be hit by a bus on the way there and will stop breathing as a result.
Now, someone is probably thinking, this is self-evident and you are being pedantic. Yes and no. Yes, no one is advocating that we all become shut-ins. However, no, the argument against testing live-attenuated vaccines (particularly a live-attenuated HSV-2 vaccine) is equally absurd because of the concept of “RELATIVE RISK.”
In order to understand the RELATIVE RISK of live vaccines, one needs to appreciate the cost of the human diseases that occur because we don’t have vaccines. The point that I, and many infectious disease experts, have tried to raise in publications and in scientific meetings is that there is a real cost to only testing so-called “safe” (i.e., FDA approvable) subunit vaccines. For example, the biomedical research enterprise has been testing “safe” HIV subunit vaccines of a wide variety of forms for the past 25 years. During the time that all those approaches were being tested and failed, at least 30 million people died of AIDS.
Let me help you with the math. By a very conservative estimate, over 3,000 people per day continue to die of AIDS for every day we only explore the possibility of HIV subunit vaccines. The reason we have never tested a live-attenuated HIV vaccine is because it would be “too dangerous.” You know what seems a lot more dangerous to me….not testing an obvious possibility while 3,000 people per day continue to die of AIDS. If that rate of death occurred in my home town of New Orleans, the city would cease to exist and be a ghost town before the next Mardi Gras in 2016. That’s dangerous. That’s scary. The human race has just grown indifferent to the fact that 1.5 million people per year are dying of AIDS.
Now, I am sure that some people are going to say that I am not an HIV researcher and I don’t know what I am talking about, and on one hand I will agree…..I am not an HIV researcher. However, one of my personal heroes in the field of virology is a man named Howard Temin whom I think the world of……humble, smart, insightful, and on target in just about every one of his publications I ever read. For people that care more about accolades than evaluating the nitty-gritty of a brilliant scientist’s life work, Howard Temin got the Nobel Prize for his work on retroviruses in the 1970s. So, lots of people other than me thought Temin was the real deal.
Where am I going with this? Temin, one of the world’s foremost retrovirologists (ever) said in 1993……hey guys, if you want to solve the AIDS problem, how about a live HIV-1 vaccine? Publication is here: http://www.ncbi.nlm.nih.gov/pubmed/8506281
So, no, I am not a retrovirologist nor am I an HIV expert, but I know enough to know that when a sage like Temin offers his honest, unpopular opinion on how to tackle AIDS, maybe we should at least listen and carefully consider the advice being offered. Howard Temin’s voice was drowned out by Big Pharma pushing for the next HIV subunit vaccine. Well, 22 years has elapsed since Temin spoke his piece and passed away the following year. Since then, another 25+ million people have died of AIDS and there is no end in sight. Lots of HIV subunit vaccines have been tested, all have failed, and the vaccine research field is adrift with people chasing the next HIV subunit vaccine and who probably at this point largely don’t even know who Howard Temin was because he was before their time. If they were smart, they would consider Temin’s advice rather than trying to make it up on the fly and hope the next HIV subunit vaccine works better than the last one that failed.
So, returning to the Science.mic article and the suggestion that my life’s work revolves around sticking it to the FDA, let me first acknowledge that I probably said something stupid like this while I was talking to the reporter. This I do not dispute. I am adept with the written word, but my verbal skills and discretion are still lacking…..maybe one day I will grow up. Maybe not.
So, having acknowledged my gaffe, please allow me to clarify what I mean. What I would like to do is convince scientific regulatory bodies like the FDA that while it is great to have legal counsel, at the end of the day lawyers don’t probably understand retroviruses better than Howard Temin did and they should not be the sole arbiters who decide which HIV-1 vaccine approaches we will pursue. I am no Howard Temin (not even close), but in my simpler world of HSV-2, a far less deadly infection, I too am suggesting that a live HSV-2 vaccine deserves far more attention than it has received in the past 30 years.
The FDA and similar regulatory bodies should be concerned with the risk of any vaccine. This, I do not dispute. However, the risk of live HIV-1 and live HSV-2 vaccines should be weighed RELATIVE TO THE RISK that HIV-1 and HSV-2 subunit vaccines may continue to fail for the next 30 years, and tens of millions of people will suffer while lawyers (not scientists) continue to dictate vaccine science policy in the USA and around the world.
So, finally, for everyone’s consideration, please allow me to cite the current risks of not having effective vaccines for the 4 infections I cite above between Jan 1, 2000 and Jan 1, 2010:
1) About 16 million people died of AIDS caused by human immunodeficiency virus 1 while we were testing safe HIV-1 subunit vaccines.
2) About 16 million people died of tuberculosis caused by Mycobacterium tuberculosis (about 25% of these people had AIDS, which allowed their TB to spin out of control) while we were focusing on safe TB vaccines.
3) About 5 million people died of malaria caused by Plasmodium while Glaxo Smith Kline was tinkering with their RTS,S subunit vaccine and everyone was waiting for the results.
4) About 100 – 200 million people contracted wild-type HSV-2 infections, and about 3% progressed to a lifetime of recurrent genital herpes disease (i.e., 3 to 6 milliion people) while Glaxo Smith Kline and others tinkered with HSV-2 subunit vaccines.
I am all for safe vaccines, but I note that vaccines are only useful if they actually prevent human disease. So, kudos to the FDA and Big Pharma for singlemindedly pushing incredibly “safe” HIV, TB, malaria, and HSV-2 vaccines for the past 30 years while tens of millions of people suffered and/or died of these infectious diseases. I note that we are currently on track to do precisely the same thing between 2015 and 2045 because FDA bureaucrats have been allowed to conflate the term “risk” into being the same as “dangerous.” This is simply not true.
I don’t want to stick it to the FDA. What I want is the “science policy makers” in the U.S. to understand some science, and make rational choices based on a real understanding of how the natural world actually works.
So, call me rogue, call me crazy, but I am going to hop on my bike right now, and go throw down a couple of pints of beer with my buddies because I think the potential benefits outweigh the potential risks. And for the same reason, I would suggest the sane and rational thing for my scientific colleagues to do is to re-evaluate “live and rationally-attenuated vaccines” to determine if, perhaps, the low risks of a live-attenuated HSV-2 vaccine might be preferable to the certainty that 10 to 20 million people per year will continue to contract new HSV-2 infections each year that HSV-2 subunit vaccines keep failing…..as they have been doing every year since the late 1980s.
– Bill H.