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FDA Requests Further Information on Dynavax/Merck´s Experimental Hepatitis B Vaccine

The Food and Drug Administration (FDA) has requested Dynavax Technologies Corp. for more information on a halted study of the developing hepatitis B vaccine Heplisav regarding a rare disease reaction in a patient, to which the biotech company has now responded regarding its trial with the experimental hepatitis B vaccine. Further details.
09-19-2008 |  10:41 hs.
Author: Cate Kirby |

The Food and Drug Administration (FDA) placed a hold on clinical trials for Dynavax Technologies Corp´s hepatitis B vaccine last March because of safety concerns, after a patient taking Heplisav was diagnosed with a rare disease that causes blood vessels to inflame.

In its response to the agency, Dynavax has confirmed the incident, but also stated the condition had been found in one of the patients taking GlaxoSmithKline´s Engerix-B. The clinical trial was set up to compare the two drugs.

In a filing with the Securities and Exchange Commission, Dinavax – whose drug development partner is Merck & Co – stated the response submitted to the FDA “contained a thorough review of both clinical and preclinical safety data for Heplisav.”

Safety results show that the profiles for Heplisav and the already-approved Engerix-B are similar, Dynavax said. The incidence of adverse events was 81.9 percent for Heplisav patients, compared with 81.4 percent for Engerix-B patients.

The FDA will now evaluate the company´s response and make a decision on whether to allow the study to continue.

I am opposed to any Hep B vaccine trials without a full probe and investigation. I'm also against the premise that the trials can induct volunteers requiring them to sign a hold harmless paper. I was infected with HIV in the Merck 1978-79 Hep B vaccine trials.
I feel I should make this concise. I was a volunteer in the Merck Hepatitis B Vaccine trials in 1979.
In 1979, the Gay Liberation Movement was a persecuted, conflicted and divided community- no more so than NYC. I was encouraged to volunteer through The Gay Mens' Health Project which later became Gay Mens' Health Crisis. It was a FREE Gay Clinic on 13th Street in an abandoned NYC school building that the City rented to local groups. This is now the LGBT Center. The clinic was free and anonymous. It provided a great database and treatment by other Gay men. In those days, human sexuality courses mostly pertained to reproduction among heterosexuals. So a lot of the information I benefited from at GMHP was helping me navigate the difference between scavies and jock itch. I knew as much about my body sexually as woman did before the suffragettes! In those days I was categorized as a 'deviate' and I made to understand that something that was "sick" as me didn't need to be cured of anything except my lifestyle!

Now imagine a company like Merck, Sharp and Dohm hiring the New York Blood Center to do a Hep B vaccine trial in the Homosexual Community! For a blue stock company that had a CEO ROY VAGELOS who resembled a character out of a Rockwell painting- actually acknowledging homosexuality! I mean how would this go down at a stock holder's meeting or in an 1978/79 Annual Report: Merck makes vaccine to save deviates! GMHP was the conduit to lure prospective candidates to be inducted. In the book Quest for the Killers by June Goodfield's chapter Vaccine on Trial, describes exactly the positive spin of this campaign. I was being patted on the head by Big Pharma! The industry that emulated the science community by not sullying itself with sex, religion or politics was finally pushing the envelope! The vaccine was considered safe for human trials. I was protecting myself, my brothers and the community by being in this vaccine trial. And if all wasn't said and done- I was even guaranteed medical care for the duration with primary physicians of my choosing! The only criteria was- that I was not in a monogamous relationship and that I didn't have the HEP B anti-bodies already. Oh! And that I had to commit to blood drawings and be committed to the trials schedules over the course of several years!

I was inoculated. Shortly afterwards my father would show me articles in the Wall Street Journal about a Black Plague effecting homosexuals. I didn't think anything about it. I was in the vaccine trial and taking care of myself so I wouldn't get Hep B. I felt nothing to fear from a Black Plague.

Then the vocabulary began to shift substantially. It was a significant shift for me. It was the beginning of the criminalizing of HIV and AIDS. At first the Black Plague was changed to GRID Gay Related Infectious Disease. Then it became Acquired Immune Deficiency Syndrome.

Look at the qualifier "Acquired"- what other disease has a reference to suggest that it was something I or anyone would go out looking to "Acquire". Why don't we say "Acquired Breast Cancer, Lymphoma, TB"? I mean even SARS didn't get to be called "Acquired"! I felt the pressure to go underground. I really believe now in hindsight that Merck had little to worry about- because the public hysteria was so high that to put the vaccine trial in question seemed very unlikely. GMHP became Gay Mens Health Crisis- a very significant change when I realizes that one of the signs of a "crisis" is a communication breakdown.

But here are some of the questions I have had to ask myself after 30 years of being silenced:

-How could I have grown HEP B anti-bodies if my body was already immune compromised with HIV? Remember this was at the very beginning when the AIDS virus was so virulent? Why didn't I come down with Hep B leaving me open to other infectious opportunistic diseases?

-How could Merck make the claim the vaccines were sterile? A vaccine is never sterile since it harbors a dead virus.

Published by: Eugene Matarese | 09-22-2008 | 11:54
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