<html xmlns:v="urn:schemas-microsoft-com:vml" xmlns:o="urn:schemas-microsoft-com:office:office" xmlns:w="urn:schemas-microsoft-com:office:word" xmlns:m="http://schemas.microsoft.com/office/2004/12/omml" xmlns="http://www.w3.org/TR/REC-html40"><head><meta http-equiv=Content-Type content="text/html; charset=us-ascii"><meta name=Generator content="Microsoft Word 15 (filtered medium)"><style><!--
/* Font Definitions */
@font-face
{font-family:"Cambria Math";
panose-1:2 4 5 3 5 4 6 3 2 4;}
@font-face
{font-family:Calibri;
panose-1:2 15 5 2 2 2 4 3 2 4;}
/* Style Definitions */
p.MsoNormal, li.MsoNormal, div.MsoNormal
{margin:0in;
margin-bottom:.0001pt;
font-size:11.0pt;
font-family:"Calibri",sans-serif;}
a:link, span.MsoHyperlink
{mso-style-priority:99;
color:#0563C1;
text-decoration:underline;}
a:visited, span.MsoHyperlinkFollowed
{mso-style-priority:99;
color:#954F72;
text-decoration:underline;}
span.EmailStyle17
{mso-style-type:personal-compose;
font-family:"Calibri",sans-serif;
color:windowtext;}
.MsoChpDefault
{mso-style-type:export-only;
font-family:"Calibri",sans-serif;}
@page WordSection1
{size:8.5in 11.0in;
margin:1.0in 1.0in 1.0in 1.0in;}
div.WordSection1
{page:WordSection1;}
--></style><!--[if gte mso 9]><xml>
<o:shapedefaults v:ext="edit" spidmax="1026" />
</xml><![endif]--><!--[if gte mso 9]><xml>
<o:shapelayout v:ext="edit">
<o:idmap v:ext="edit" data="1" />
</o:shapelayout></xml><![endif]--></head><body lang=EN-US link="#0563C1" vlink="#954F72"><div class=WordSection1><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Big news story today about one of Peter Thiel’s ventures.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><a href="http://www.thedailybeast.com/authorities-launch-investigation-of-unethical-offshore-herpes-trial-backed-by-peter-thiel">http://www.thedailybeast.com/authorities-launch-investigation-of-unethical-offshore-herpes-trial-backed-by-peter-thiel</a><o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>He wanted to test a vaccine for herpes, but in the USA, any such drug test costs billions to control and jump through all the government hoops. This means that any treatment which cannot make back that initial investment can never be approved by the FDA. So the protections put in place by the US government prevent new therapies and drugs.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Since many countries do not have anything analogous to the US FDA, they can just use the drugs developed and approved by the US. The staggering expense of FDA approval prevents new medications all over the world.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Thiel was being himself: he went to Mexico and Australia where they don’t worry too much about these kinds of things and tested the vaccines without all the costly control and oversight required by the FDA. <o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>The big deal is that they used test subjects in the Caribbean in St. Kitts, including (drum roll) American citizens. (“GASP!” they gasped.) Thiel’s detractors are saying this is unethical (What is the unethical part? (Going around the American FDA or experimenting on actual (gasp!) Americans? (Would it be an ethical experiment had it disallowed US citizens?))) <o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Thiel’s argument: the volunteers who took the vaccines already had herpes and did not have access to treatment. So the worst that could happen is nothing.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>What happens if Thiel discovers this vaccine works, but declines to do FDA testing? Then do we have a drug which can be used overseas but is illegal in the USA? Would it then be kinda like cocaine except that it actually prevents disease instead of getting the user stoned? Imagine if other investors recognize that there are markets for drugs outside the USA and that the approval process here has gone from difficult to absurd. Then they follow suit and create new classes of drugs and therapies using populations willing to take chance.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Ethics hipsters among us, do offer your insights please.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>spike<o:p></o:p></p></div></body></html>