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Wolf Szmuness and the hepatitis B vaccine trial


Patenting and finding an manufacturer for the vaccine
Baruch Blumberg Physician
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Well, this was the unique kind of vaccine of course because nobody's made a vaccine like that in the past and my guess is nobody ever will because not… very few viruses have this characteristic. It's quite rare actually. There's a equine encephalitis virus that has a similar, cauliflower mosaic virus — strange connections, but it was quite rare and people now… just about a few years later is when the Aids epidemic started... and people were very reluctant to use blood products. They still continued to do so but in any case, so we… we patented it and that was in '69 and, you know, I spoke about it in talks and published some information on it but we… there was no interest in it and with… it wasn't surprising and in a way we didn't kind of push it because — not that it wasn't important and you might say, well, you had an obligation to push it — well, I… I think it's fair to say we wanted more evidence, too. You know in order to… to enthusiastically put… you have to have something other than what we said. We needed confirmation as… as did the… the producing companies, the pharmaceutical companies. So we continued working. We did a lot of stuff and then other people got involved fortunately and there was a series of animal-related studies that were done in the mid 70s and I went to the meeting at which that was presented in 1975, before that, in ’72, '73 and I came back and I said, ‘Irv, this data is very convincing. It supports what our view is and from another group, not us, let's really push patent’. Well, I won't go into the complications but the Fox Chase did not… was not granted the domestic rights to the patent by, but by a set of unusual circumstances, we were given the foreign rights so that meant we could patent it abroad. So Irv and I in the middle of the winter, you know, flew over to Europe and we talked to some of the big pharmaceutical firms in… in Britain who we had contact with, Belgium firm and we met people in Paris and the… the French company was… was quite interested but I thought, look, let's go back home, we'll take one more stab at… at domestic manufacture.

Well, we'd actually had negotiations with the Merck company, which is where you work now in West Point and… and they expressed an interest in it as early as 1971, I think it was the first correspondence I had from them, but nothing much, I mean we couldn't sort of push it. They, you know, the drug companies have their own agenda. They don't like… they prefer to… it's got to be their own stuff, you know, and all that and we didn't have much convincing data but we did if we came back from France because we could then say we're going to go ahead with this and we want to, well, part of it is we thought it would be good to manufacture it domestically. We could keep, you know, we would have the better view of it and it was also in Pennsylvania, you know, we were funded by Pennsylvania institution, by… by the state, partially funded. So we went and saw him again, but this time I went with Wing Pepper. I think you knew G Willing Pepper, wonderful man. He was the chairman of our board of trustees and, by the way, a naval hero. You know, he… his ship was sunk in the naval engagement of… during the battle of Guadalcanal. He was in the water for a day, finally rescued. He nearly… nearly died and then went on to continue, you know, an outstanding career in the navy and he was a very successful businessman and a very good one, and a very decent man. So Wing and I drove to Rahway to talk to the CEO, I guess, of… of Merck and I went in there and, well, Wing knew him, you know, because, you know, they were kind of, CEOs sort of know each other. They were sort of sitting there, chatting, you know, talking about mutual friends and golf and sort of making jokes, occasionally referring to the vaccine. There was sort of banter back and forth, which I sort of... I got sort of distracted, I'm not sure I really followed it all, but we went out, you know, with… left in, we were in the anteroom and I said, ‘Well, Wing, what happened? I… I got the impression that they are not very interested’, and he said, ‘On the contrary, they want to go ahead’.

[Q] I can identify with that ‘guess what I'm thinking’ attitude!

So… so we did… we had… we had a very successful… and they… they… we consulted with them to some extent but not much. You know, they were quite happy to develop it on their own, but from what I can make out, from what I know is they pretty much followed the methods given in our… in our patent and they produced large quantities under very high standards and then they fortunately selected Dr Wolf Szmuness who was then at the New York Blood Center to do the field trials.

American research physician Baruch Blumberg (1925-2011) was co-recipient of the Nobel Prize in Physiology or Medicine in 1976 along with D Carleton Gajdusek for their work on the origins and spread of infectious viral diseases that led to the discovery of the hepatitis B virus. Blumberg’s work covered many areas including clinical research, epidemiology, virology, genetics and anthropology.

Listeners: Rebecca Blanchard

Dr Rebecca Blanchard is Director of Clinical Pharmacology at Merck & Co., Inc. in Upper Gwynedd, Pennsylvania. Her education includes a BSc in Pharmacy from Albany College of Pharmacy and a PhD in Pharmaceutical Chemistry from the University of Utah in Salt Lake City. While at Utah, she studied in the laboratories of Dr Raymond Galinsky and Dr Michael Franklin with an emphasis on drug metabolism pathways. After receiving her PhD, Dr Blanchard completed postdoctoral studies with Dr Richard Weinshilboum at the Mayo Clinic with a focus on human pharmacogenetics. While at Mayo, she cloned the human sulfotransferase gene SULT1A1 and identified and functionally characterized common genetic polymorphisms in the SULT1A1 gene. From 1998 to 2004 Dr Blanchard was an Assistant Professor at Fox Chase Cancer Center in Philadelphia. In 2005 she joined the Clinical Pharmacology Department at Merck & Co., Inc. where her work today continues in the early and late development of several novel drugs. At Merck, she has contributed as Clinical Pharmacology Representative on CGRP, Renin, Losartan, Lurasidone and TRPV1 programs and serves as chair of the TRPV1 development team. Dr Blanchard is also Co-chair of the Neurology Pharmacogenomics Working Group at Merck. Nationally, she has served the American Society of Clinical Pharmacology and Therapeutics on the Strategic Task Force and the Board of Directors. Dr Blanchard has also served on NIH study sections, and several Foundation Scientific Advisory Boards.

Tags: Merck, G Willing Pepper

Duration: 6 minutes, 1 second

Date story recorded: September 2007

Date story went live: 28 September 2009