A "SECOND OPINION" EXTRA

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HOMELAND HIJINKS AND WHITE HOUSE WHITEWASH:
The Bush Administration Is Not Only Protecting The Vaccine Manufacturers But Also The FDA By Sneaking In Fine Print Into The Homeland Bill
By Nicholas Regush

As you know by now, the Homeland Bill contains several peculiar wrinkles that have little to do with security. As is typical in the U.S., politically-contrived weird stuff gets attached to bills, often as a result of the slime politics that go on in backrooms. In this particular instance, it is the White House that wanted ridiculous breaks for drug companies thrown into the 484-page Homeland Bill.

So, for example, if you are, say, Eli Lilly, this is a happy time because the Bill, if passed, would allow you special protection against any lawsuits claiming that Thimerosal, the mercury preservative for vaccines that you have been peddling for years, causes neurodevelopment problems, including autism.

Now why would the White House want to protect the drug industry (aside from the fact that it contributes heavily to Republican coffers)? The official reason making the rounds this week is that liability protection would give the vaccine industry that extra bit of confidence to go ahead and make the necessary vaccines against the "bioterrorism threat."

No more worries about all those pending lawsuits claiming that Thimerosal caused damage to children.

If the White House wants us to believe this crock, then it should be very pleased to provide detailed evidence of the profit trends of companies which continue to make vaccines. Why hold back, show us that these very impoverished companies are on death�s row and that they will be incapable of producing vaccine for the masses in case of a biowar. Let�s see the data.

The fact is, the vaccine industry is truly in a mess, but not for the reasons the White House would have us believe. The industry does not do relevant research on vaccines and continues, with help from its CDC, FDA and doctor friends, to heap one vaccine after another on children without doing anything close to what might be considered appropriate safety and efficacy research. And this has been going on for decades.

The Thimerosal issue made this all so simple to see: a preservative put into vaccines that the FDA did absolutely nothing about until December 14, 1998, when it first asked manufacturers of vaccines to provide detailed information about the ingredients they used in their products.

That came on the heels of the FDA Modernization Act of 1997 which prompted the agency to try to establish the levels of risk for all food and drugs containing mercury. By then it was a non-brainer that mercury could be highly toxic. But when you get right down to it, the FDA intervention was a long time coming because Thimerosal had been in use since the early 1930s.

Almost 50 per cent organic mercury by weight, it was never necessary to maker a vaccine either safe or effective. It offers protection against the possibility of a vaccine becoming contaminated when a health professional introduces one needle after another into a multi-dose vial as shots are needed.

FDA documents indicate that the concerns about Thimerosal rose sharply once the data from the vaccine manufacturers began to be analyzed in 1999. In fact, referring to the concerns as at least "mild panic" would not be inappropriate. It quickly became evident that many millions of children in North America and elsewhere might have been receiving overdoses of mercury from vaccines and that many might have been poisoned.

Especially at issue were three vaccines from among those on the recommended schedule for children under six months of age. Three doses of DTaP (the newest type of vaccine for diphtheria-tetanus-pertussis) amounted to 75 micrograms of mercury. The same was true for three doses of the Haemophilus influenzae type b vaccine, given to protect against a range of bacterial infections, including meningitis. And three doses of the hepatitis B vaccine yielded 37.5 micrograms. The total of 187.5 micrograms of mercury over six months greatly exceeded the safe limit set by the Environmental Protection Agency (EPA) of 0.1 micrograms per kilo of body weight per day. For example, for a child following the standard vaccination schedule, shots at two months of age would yield 62.5 micrograms of mercury. Depending on the child�s body weight, that could result in more than 30 times the EPA�s recommended daily maximum exposure.

Unfortunately, the FDA, which was, at long last, trying to whip itself into some shape on Thimerosal, wasn�t really clear on the concept. What did those data really mean? For one thing, the EPA�s safe limit was, at best, a crude estimate, based on very little research. Also, that estimate was for methyl mercury and it was actually ethyl mercury that is the active ingredient in Thimerosal. The conundrum was that there was relatively little scientific data available on the toxicity of lower doses of this particular compound, even though it is a chemical cousin to methyl mercury. So, given the lack of data and appropriate federal guidelines upon which to base a proper risk assessment, the FDA decided to assume that both forms of mercury were similar. Not exactly what one might call science, but the agency had been caught with its pants down. All that mercury being injected into infants, and in large quantities too, and there was little, if any, understanding of the health effects.

On what basis, then, was Thimerosal ever considered safe for use in vaccines? To dig up the answer, you have to go back to the late 1920s. Documents from Eli Lilly show that the pharmaceutical giant had sponsored a human toxicity study with Thimerosal, but the choice was odd because the product was used on patients already dying from meningitis. In other words, how could the company possibly determine whether the product was toxic or harmful if people were as good as dead when the study began?

That type of preliminary study, to make any sense, should have been conducted on healthy volunteers. But the company claimed that Thimerosal was not harmful to humans. And since there was no stampede to determine whether there was competent science behind the study, it became an urban legend of sorts.

To date, there have been no published studies whatsoever, that have specifically examined the exposure of infants to ethyl mercury and its health effects.

And now the White House wants to whitewash this offensive history and give the drug industry as well as the FDA a wink as business continues as usual.

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