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A Faulty Gardasil Clinical Trial Process Caused “Too Fast” Approval

Michael Lin Baum

· Vaccine

Michael Lin Baum is a longtime Southern California lawyer who has represented thousands of clients in personal injury and wrongful death cases connected to manufacturing defects and pharmaceutical drugs. As an attorney at Baum Hedlund Aristei & Goldman, Michael Lin Baum has worked on cases centered on serious injuries and deaths linked to the Merck & Co. human papillomavirus vaccine Gardasil.

Given to adolescents as well as adults, the vaccine has potentially dangerous ingredients such as amorphous aluminum hydroxyphosphate sulfate (AAHS). The known neurotoxin is associated with severe adverse reactions. Health issues with the drug date back to the expedited US Food and Drug Administration clinical trials, which led to Gardasil’s approval in only six months.

According to medical professionals who published an article in the British Medical Journal, a major problem with the trial design was that the control group (not receiving Gardasil treatment) received a faulty placebo that lacked the appropriate saline formulation. Rather, it contained AAHS, along with other additives, so that different effects observed between the placebo-administered control group and those who took Gardasil over the course of the study were distorted.

As a result, lawsuits allege that Gardasil appeared safer to those who make drug approval decisions in the FDA than it actually was. One of the principal investigators who took part in human testing associated with the Gardasil clinical trials subsequently observed that the trial process “went too fast.” Today, major health concerns exist among those who have been given the Gardasil vaccine, with the most prominent being postural orthostatic tachycardia syndrome, or POTS.

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