The following story offers a powerful glimpse at the deep pathology at work in Fresenius.

Recall that different acid formulations cause different biochemical responses in the liver. Some acids promote higher blood bicarbonate levels than others do. Recall also that higher blood bicarbonate levels can lead to metabolic alkalosis, which can in turn cause cardiac arrest, arrhythmias and other potential fatal side effects.

Now consider this statement that Fresenius submitted to the FDA in April 1991, in an attempt to win the agency’s approval for its new drug, GranuFlo: “the real difference between the use of sodium diacetate and acetic acid is the amount of sodium introduced into the solution, but since the sodium ion is also introduced by the use of other sodium containing salts, the sodium ion can be controlled with their adjustments… the use of sodium diacetate or acetic acid will have no effect on the final content of the solution. One would not be able to tell, in fact, whether acetic acid or sodium diacetate had been used.” (bold and italics are ours)

That statement sounds like a convincing refutation to the argument that “sodium diacetate à more alkaline byproducts in the blood à causes health problems.” After all, if sodium diacetate and acetic acid are, for all intents and purposes, identical — at least insofar as their effect on blood alkalinity is concerned — then there is nothing particularly dangerous about GranuFlo or any kidney dialysis product that uses sodium diacetate formulations.

But where did Fresenius get this information? Did the company run a variety of tightly controlled tests? Did the company study the biochemistry in depth? The answer may shock you: evidence suggests that company officials simply looked up “sodium diacetate” in the dictionary… and nothing more.

In fact, at the time when Fresenius made its bold claim, sodium diacetate had never been used in hemodialysis in human beings. In other words, there was no science — zero research — to support the idea that sodium diacetate and acetic acid would have identical effects.

So what went wrong here?

• Did Fresenius purposely try to confuse the FDA?
• Was the company simply lazy?
• Why did FDA officials fail to scrutinize Fresenius’s claims?
• Have there been other, similar examples of Fresenius’s scientific malfeasance? Or was this an outlier?

More on these questions next time. If you or a loved one needs an evaluation of your GranuFlo case, call the Davis & Crump team now at 800-277-0300 or email us at info@daviscrump.com.