My name is Sasha Latypova. Thank you for listening to me. I speak in support of s1036. My career for 25 years has [been] spent on pharmaceutical research and development, working on hundreds of clinical trials, including for large companies, like Pfizer, who were my key client and investor. I interacted with FDA on behalf of my clients in regulatory submissions.
Doug Cameron was permanently disabled by a single shot from Janssen vaccine lot 18-05020, manufactured in December 2020. This lot is associated with over 1300 adverse events and 25 deaths, including one person in Idaho, 56-year-old male. This lot wasn't the most toxic. There are lots that generated 5 to 7,000 severe adverse events and hundreds of deaths per lot. In my 25-year career, even a fraction of these events would have resulted in the total product recall from market. This never happened. FDA never enforced any pharmaceutical law. They do not enforce pharmaceutical law in relation to EUA countermeasures on the public health emergency. This is federal law. These products are currently covered by PREP Act declarations, which are still in place until the end of 2029. So the law is not enforceable. People were not informed about it. There are no expected consumer safety protections, such as good manufacturing practice enforcement and marketing claims of enforcement. Everyone who advertised these shots as nearly 100% safe and effective used these empty words without any legal meaning. Lack of good manufacturing practice enforcement for these shots means that no informed consent is possible or meaningful, because neither the healthcare providers nor the recipients have assurance about the purity, potency, and safety, nor about the content of the vials, and the content varies by gigantic amounts from lot to lot. When taken to court for false claims of efficacy and safety, pharmaceutical companies, including Pfizer and others, have successfully used the PREP Act as a liability shield today, claiming that they delivered what the government ordered, large-scale manufacturing demonstrations, meaning fraud by definition.
Thank you very much and please consider supporting this bill.
