The Conspiratorial

Sandra had managed about 60 clinical trials in her short career with Scripps. Her primary task was to make sure the trials were administered correctly, to insure the absolute safety of the participants and to deliver the final results report. Double-blind trials were nothing new but that didn’t mean double stupid. Sandra did her homework with respect to who was running the trial, what they were hoping to achieve, how they would get their results and why they were running the trial. The ‘who’ in this case was Sanofi-Pasteur. Sanofi-Pasteur was the worlds largest manufacturer of vaccines, capable of producing almost two billion vaccine doses annually.

Historically, there always seemed to be a common thread in the research that Sandra did relative to the drug industry. If you go back far enough, the same names pop up time and again. Rockefeller was distinct among them. In 1917, Rockefeller made millions in vaccine sales. In the spring and summer of 1917, America was preparing for war. American men were drafted into military service and deployed for training in Spain. All new recruits were given mandatory vaccinations, one of which was a broad-sprectrum Influenza vaccination. In 1918, the world was hit with the ‘Spanish Flu’. The Spanish Flu was aptly named in reference to the eight million Spaniards who died in May of 1918. In the midst and distraction of war, few seemed to notice even the obvious.  The first wave of influenza reared its head in the spring of 1918 in Kansas and in military camps throughout the US shortly after the vaccination programs.  Noone ever thought to question that the vaccinations themselves might be the source but Sandra couldn’t get that thought out of her head. The evidence was just too compelling but seemingly most people were distracted at the time. It was, afterall, wartime. Wilson had just given his 14 point address. So, there was virtually no response or acknowledgment to the epidemics in March and April of 1918 in the U.S. military camps. In the end, the flu was responsible for half of the death toll of American soldiers and 30 million people worldwide.

As The Great War came to an end, so too had the effects of the Spanish Flu. The heads of various multinational banks met in conference at San Remo, Italy in 1924 to place war reparations on Germany. And there was Rockefeller again. On March 28, 1924, Rockefeller officially formed a French Oil conglomerate named “Total”. Today, Total Inc. is a multi-national mega-corporation operating in 130 countries with over 110,000 employees. Two of Total’s prime, wholly-owned subsidiaries, are the Pharmaceutical giants – Sanofi-Aventis and Sanofi-Pasteur.

The other ‘who’ in this trial was MedImmune. Wayne T. Hockmeyer, founder of MedImmune received his BS at Purdue University in 1966 and is PhD at the University of Florida in 1972. In 8 short, relatively uneventful years, he found himself in the Department of Defense as Chairman in the Immunology Dept., at the Walter Reed Army Institute of Research. At a time when bio-technology was just emerging, Wayne was smack-dab in the middle of it. The Department of Defense was on the bleeding edge of BioTech research and Wayne got a first class seat to both witness and participate. As Sandra read through the National Academies Press archives, she found herself drawn into the history like she’d never been in her academic career. Perhaps this had more bite and relavence. In 1974, the emergence of “Biotechnology” surfaced with a new patent application that ‘provided a means to manipulate, or recombine, genetic material into useful, commercial products that are more naturally acceptable to the human body and its environment”. Biotechnology was a field defined as the use of recombinant DNA methods or broadly defined as anything related to life sciences. Wayne Hockmeyer would take his knowledge of genetics and immunology, and his experience at the DOD to start up a new biotech company in 1987 named Molecular Vaccines, Inc., renamed MedImmune 2 years later. 20 Years later, MedImmune became a wholly own subsidiary of AstraZeneca. The most recent accomplishments associated with MedImmune involved the reverse engineering of viruses. With all this information, Sandra could only utter a single word, “huh…” and moved on.

Bird Flu Clinical Trials Fail

With respect to the task at hand, Sonofi-Pasteur had already completed several clinical trials. Sandra blew by most of the reports as typical if not informational. However, one report in the UK Telegraph did not report your typical clinical trial results. The title of the article was ‘Homeless people die after bird flu vaccine trial in Poland’. Reports were sketchy with respect to who did what. Sanofi-Pasteur and Novartis were mentioned as possible sponsors of the trial but the report seemed to relegate blame to the local medical personnel. To what end, Sandra could not even imagine.

With all the information she had about ‘who’; Sandra was now digging into ‘why’. In a press release dated November 2007, Sanofi-Pasteur announced that Leavitt, head of the department of Health and Human Services (HHS) authorized the purchase of 100-million dollars worth of H5N1 vaccines from Sanofi-Pasteur. They further indicated that the cell-based vaccine would be mass produced in the company’s China facility – then shipped to Stillwater, Pennsylvania for hypodermic syringe-friendly packaging. So if the vaccine was already approved and in fact the US Government was stockpiling, then, why? Apparantly, this decision had been made without prior animal or human testing, or at least none that they cared to report. Sandra realized that she had just signed up for that detail and the thought was not sitting well with her.

She was starting to put together the ‘how’ with the little information that she had already obtained. She already knew from the description in the clinical trial application that it involved a live viral component. That was initially what caught her attention. She thought it could help with Raymond’s little side hobby.  She did not need to go that far to connect the dots. In June of 2007, MedImmune, Inc. was awarded a 55 million dollar contract from the Department of Health and Human Services to modify its U.S. vaccine manufacturing facilities to produce pandemic influenza vaccines using its live, attenuated, needle-free technology. MedImmune was experienced at delivering vaccines via an inhalent type apparatus and in fact already delivered standard influenza A and B vaccines called FluMist in local clinics and even Walmarts across the US. In the same stroke of the pen, Sanofi Pasteur was awarded a $77.4 million contract to modify its own flu vaccine manufacturing facility in the U.S.

The clinical trial Sandra had signed up for was to run the productized results of this marriage through human clinical studies. She was not at all comfortable with her decision to do so. Something told her that this summer was not going to be the picnic in the park she’d told Chris Van Gorder it would be. For that matter, she was beginning to feel a pang of guilt at dragging Raymond into this.