(Editor’s note: Companies owned by multi-billion pharma giant Sanofi, have paid huge criminal fines in the past (feel free to look it up in the mainstream media) so the fact that professors and medical doctors think this is horrific, too does not surprise us!)
Sanofi Pasteur, one the world’s leading vaccine makers (No. 2 among vaccine makers, with global sales of $6 billion) with a checkered past, had a potentially serious and costly problem on its hands in April of 2013: Its Monroe County plant discovered pieces of glass in batches of a vaccine intended for babies. It is unclear how many ActHIB vaccines affected by delamination were distributed as Sanofi refused to provide numbers when asked.
The glass was found in samples of a vaccine that had already been distributed to customers and which would not expire until September 2014. Sanofi did the right thing and sent the samples to an outside laboratory for analysis where the lab found evidence of delamination (which occurs when vaccine vials shed flakes of glass called lamellae).
But, in true Big Pharma fashion, their responsibility stopped there.
Sanofi allowed doctors and nurses all over the country to continue injecting babies with the potentially problematic ActHIB for another YEAR AND A HALF.
The FDA didn’t do a thing. Why? They trusted the company’s assurances that the vaccine was safe. That’s like asking the fox to guard the hen house!
STILL think your vaccines are safe and that the FDA is first and foremost concerned about your welfare and the welfare of your child?
(The health risks posed to someone, by vaccine vial delamination, are widely believed to be minuscule- although there exists a potential for blood clots to form as a result of contaminated vaccines that are administered intravenously (directly into a vein). But then and again, vaccines themselves are widely believed to be safe. And yet, EVERY YEAR, thousands and thousands of kids have life threatening, life altering and life ending side effects. But not only that, as a parent, don’t you at least want the opportunity to say, “No thank you, I’ll take the vaccine without small flecks of glass.”)
The reason we are only NOW hearing about this is because The Morning Call pieced together what happened, including Sanofi’s behind-the-scenes interactions with the FDA, using government documents acquired through the Freedom of Information Act. (A huge “Thank You” to The Morning Call.)
Sanofi spokesman Sean Clements responded to questions in an email like this:
“Asked why the company did not notify the public or issue a recall for the vaccines, which are used to inoculate children against a bacterial infection that can cause meningitis, he said, “The products that were shipped from our facilities met the applicable requirements and specifications for safety and efficacy. There were no additional actions required by FDA.”
With good reason, some experts and watchdogs in the industry believe the company’s and the FDA’s handling of the matter raises important questions and concerns:
John G. Culhane, an expert in health policy law at the Delaware Law School of Widener University in Chester, Delaware County: “If you think your product has a defect, recall the damn thing. Why wouldn’t a company want to? … A lot of times, it’s a matter of economics.”
Dr. Michael Carome, director of the health research group at Public Citizen, an advocacy group in Washington: he chalks it up to the deference the agency affords the pharmaceutical companies it is charged with regulating and the extent to which it relies on the companies to monitor themselves, “Too often the FDA is not an effective regulator. They are often too slow to act when there are serious problems. The [pharmaceutical] industry is more like a client or customer of the agency, and less like a regulated entity.” The lack of transparency, he said, “leads to distrust in the heath care system and the companies that make these products.”
And this happens a lot, to all manufacturers:
• 2010: Baxter recalled an estimated 3,500 vials of Hylenex recombinant.
• 2010: Amgen recalled Epogen and Procrit.
• 2013: Fresenius Kabi USA recalled benztropine mesylate, a treatment for Parkinson’s disease.
• 2013: Merck recalled a lot of Gardasil vaccine.
At any point, Sanofi could have done the same thing. But they didn’t.
In fact, finding the delamination didn’t even lead to an examination of other products that used vials from the same vendor. But they did get back to the FDA and let them know that the glass particles in the vials weren’t lamellae but simply glass chips from damaged vials. They then placed the blame on an unnamed third-party contractor:
“Significantly, we have changed the manufacturer of the vials,” Sanofi spokesman Clements said. “While we don’t disclose specifics of our operation or details on our investment, as part of continuous improvements to strengthen our manufacturing operations and quality systems, we worked closely with the FDA in our remediation plans.”
The FDA and Sanofi both had spokespeople who said that at no point was a recall necessary because at no point was anyone in any danger. But again, it would have been nice to at least be informed. However, the FDA doesn’t really want us making our own decisions or using our brains. They want us to blindly trust and follow what they say so they can keep lining their pockets.
Remember how Sanofi changed vial companies, because THEY were the actual cause of the problem? Well, in Jan of 2015, Sanofi informed the FDA it had found particulates in another new batch of ActHIB. Well, an analysis determined some but not all of the particulates were lamellae; some were just mysterious bits of glass not caused by delamination, and one was a piece of stainless steel.