Why is Drug Company with 50 Years of Proven Safety Violations Using Taxpayer Money to Make Next Gen Flu Vaccine?

The Author Points Out:

Baxter not only has a contract to create and manufacture a new and very different seasonal and pandemic flu vaccine, but is being paid 100 percent for it by US taxpayers.

Yes, Baxter, together with a partner, DynPort Vaccine Co. (DVC) has been receiving federal funds for this influenza vaccine project since May 2006. And, in Baxter’s own words on a press release about this new vaccine, “100 percent of the total of this project's costs are financed with Federal (United States Government) money!”

This novel vaccine is made with something called Vero cell cultures. What is interesting is that this is the same vaccine that Baxter was developing in Europe, but decided to stop working on in December 2004, when Baxter told the New York Times that it had halted a late-stage clinical trial of a cell culture flu vaccine called PreFluCel because of a higher than expected rate of fever in earlier trial participants.

At the time, Baxter wasn’t sure what was causing these side effects. But the company made a point of defending the Vero cell culture process, saying that “successful vaccines for diseases other than flu were already made by the same process.”

While the New York Times doesn’t mention which vaccines those are, I can tell you that one of them is the polio vaccine, which was first made with this process beginning in the 1960s.

Vero Cell Culture Process = Cancer-Causing Monkey Virus

It was almost exactly 10 years ago when the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed a report on the use of Vero cells, derived from the kidney of an African green monkey,for the production of viral vaccines. Because the Vero cell process enables drug makers to manufacture vaccines much faster than the traditional egg growth medium, several companies were eager to switch to it.

The reason for the special meeting was to determine if Vero cell vaccines could be made safely. The reason for the safety issue was because of problems that had come up with the trivalent (three-strain) polio vaccine.

And the problems were serious: Too late -- meaning after they had already given this particular polio vaccine to countless numbers of people -- scientists discovered that it was possible for unknown, undetectable, cancer-causing viruses to tag along in the Vero cell culture. In this case, it was a cancer-causing type of virus called SV-40, which until the human vaccine was developed, was only found in monkeys.

As it turns out, Vero cells are sensitive to infection with several different types of viruses that are, or could be, made into vaccines, such as measles, rubella, polioviruses, influenza viruses, parainfluenza viruses, respiratory syncytial viruses, and vaccinia (pox viruses).

But they also are sensitive to SV-40, an animal carcinogen (cancer-causing) virus.

It took a few years, but SV-40 was later found in people with brain, bone and lung cancers. They were people who had been inoculated with Vero cell culture polio vaccine, a fact that was confirmed by the Institute of Medicine in 2002. You can read more about SV-40 and its cancer-causing potential on the SV-40 Foundation website.

But what is important here is what the scientists said:

“The discovery of this new virus, the vacuolating agent, represents the detection for the first time of a hitherto “non-detectable” simian virus of monkey renal cultures and raises the important question of the existence of other such viruses.”

Today, SV-40 is listed as a Class 2A human carcinogen.

Here We Go, All Over Again

In its 2000 report on Vero Cell Cultures, the FDA discussed methods that scientists said they could, and would, use to prevent things like this from happening in the future.

Ironically, the drug companies’ rationale today for using Vero cells is that this type of technology supposedly provides a cleaner, more pure method of growing vaccine cells than the egg process method.

But is that a guarantee, particularly when you’re talking about a pharmaceutical company with such a long history of blunders, mistakes, and documented lack of safety and poor quality control like Baxter’s?

For the answer, we can look at what the Center for Infectious Disease Research and Policy (CIDRAP) said in 2008, when it was reviewing Baxter’s H5N1 bird flu vaccine, Celvapan (which contains the same extremely lethal virus that Baxter “accidentally” shipped out instead of the relatively benign H1N1 virus) ...

Although CIDRAP hailed Baxter’s H5N1 Vero cell culture process for its ability to boost immune responses with a shorter production time, CIDRAP also said this is “a combination that entails some risk.”

And the risk, CIDRAP said, is that “the virus might somehow escape.”

Did they say escape, as in perhaps being accidentally shipped in place of another virus that was hardly lethal at all, in comparison? Or was CIDRAP just accidentally being clairvoyant, seeing how that’s exactly what happened?

I won’t belabor the point by reminding you that, mistakes aside, Baxter will soon be asking you to trust it with its latest Vero cell culture vaccines for seasonal and H1N1 flu. But some questions still remain: First, did Baxter figure out what was causing the unusually high fevers in its European version of its new vaccine?

Or did the company just forge ahead in the US, without addressing those issues?

And second, given Baxter’s repetitive, blundering history with FDA recalls alone, just what assurance do you have that, even if Baxter has addressed the higher-than-expected side effects issues, that they aren’t still going to be a problem?

The answer is, you don’t have any assurance. All you have, really, are the examples that Baxter has already set. And you now have a better idea of what they are.