Several blog followers have asked me via comments or by email, “What next?”
I very briefly highlight the plan of attack, and will then be reducing my presence on the blog for a while, so that I can focus my attention on the goals I highlight below.
First and foremost, there is quite a bit of data from the clinical trial (i.e., blood antibody responses to HSV-2) that I and other members of Team RVx’s science team will have to finish analyzing. As this data becomes available, I will be making it public on RVx’s website.
Second, Team RVx will be working on finding host countries where we can offer the therapeutic HSV-2 vaccine to sufferers ASAP. Without question, there is still a lot of science that remains to be done to figure out why the therapeutic HSV-2 vaccine works far better than any herpes immunologist would expect. However, in the absence of herpes treatments that effectively alleviate the suffering of millions of people living with chronic and unrelenting herpetic disease for years to decades, the first priority should not be to answer the endless question of science dweebs (of whom I am certainly one), but rather should be on alleviating chronic pain and human suffering. Therefore, RVx’s highest priority is getting better herpes treatments to those who suffer with symptoms that are simply not addressed by the current standard of care for herpes sufferers in the USA and elsewhere; namely, prophylactic acyclovir-like antiviral drugs. I cannot offer specifics yet, but such negotiations and navigation of the political landscape in many potential countries takes time. This is Team RVx’s highest priority.
Third, Team RVx has every intention of bringing safe and effective HSV vaccines to the global market. While we will not rule out the U.S. and the FDA, there are 200 other countries on Earth, and many of those countries are known to offer a far more efficient process for vetting new biotechnologies such that (1) the science is done right but (2) the time spent talking to regulatory oversight bodies is more on the order of months rather than decades. Whichever countries serve as host to this activity, such a venue would be the place for dozens of small clinical trials to address a myriad of questions about the therapeutic and preventative potential of live-attenuated HSV vaccines. This is where most of the basic science would transpire to better understand the properties of live HSV ICP0- mutant vaccines in human recipients and the durability of the protective immune response they elicit.
Fourth, I personally will spend my time focused on getting the message on this blog into newspapers, magazines, and potentially on television interviews. This is time that I would have spent on the blog, but instead I will focus on disseminating the message to a broader audience. That, and I might attend a scientific conference or twenty.
Against this background, while followers of the blog may be personally disappointed that my presence in this particular forum is decreased, I believe that most of you will understand that my focus should be on the four goals I outline above, and no longer on the blog answering each individual question as it arises. I will try to stop in on the blog and answer a question here and a question there as time allows. However, for the next few months, my attention will have to focus on the steps I outline above so that I can move beyond words, and focus more on the actions required to advance this new class of live-attenuated HSV vaccines to the clinics where they may help doctors begin to (1) better control / reduce herpetic disease severity in sufferers and (2) prevent HSV transmission within discordant couples.
A second question followers of the blog have been asking is, “How can we help?”
First, when RVx makes our vaccines available in a country outside of the USA, those of you who can afford to do so, please consider traveling to receive this treatment.
Second, for those of you who cannot afford to travel to another country, please consider contacting your senators or representatives in the U.S. Congress and ask them the following series of questions, or questions that follow this line of reasoning:
“Why is the best HSV treatment in the world, developed in the USA, not more readily available for Americans to benefit from at home?”
“Why is a live-attenuated HSV vaccine that was developed with dollars provided by U.S. taxpayers not more readily accessible to Americans?”
“Why does an American vaccine developed by an American scientist have to leave the USA to be offered to Americans who then have to travel outside their own country to receive a treatment that they need?”
I am happy to help bring the technology forward to the world. However, it is up to Americans who suffer with chronic herpetic disease to lean on their representatives in the U.S. Congress and ask them to re-evaluate whether current U.S. laws and regulations in the space of vaccine development really serve the interests of the American people.
I would suggest that “The road to hell is paved with good intentions.” More specifically, the status quo of how vaccines are developed in the USA today came to be through a combination of (1) inertia and neglect by lawmakers and the FDA and (2) Big Pharma companies who exploited these rules to reinforce their monopoly on the sale & development of biologics in the USA. As we all know, the U.S. pharmaceutical industry has gotten quite comfortable in the past 20 years with extorting fabulous sums of money out of the U.S. government and private citizens in the USA, who pay far more per capita for their drugs / biologics than the citizens of any other country on the face of the Earth.
It is time for today’s lawmakers in the USA to reconsider the current rules that would lead an American scientist, funded by the American taxpayers, to take his invention to a nation outside the USA because the U.S. landscape for vaccine development is simply that regressive and prohibitively expensive in terms of dollars and time. The fact that there is now overwhelming evidence in support of the safety and effectiveness of a live HSV ICP0- mutant vaccine apparently is irrelevant; there is simply no viable path forward for an effective herpes vaccine in the USA. The U.S. Congress, and the U.S. Congress alone, has the power to change the legal landscape and restore the USA to its former status as a country capable of developing life-saving and/or live-improving vaccines. It is up to Americans who have suffered with chronic herpetic disease to demand a change, and demand that this disease finally be addressed (1) at home in the USA and (2) friggin’ ASAP.
– Bill H.