AdminM said:

National and international health agencies such as the Centers for Disease Control and Prevention (CDC), the European Medicines Agency (EMA) and the World Health Organization (WHO) routinely and emphatically claim that serious adverse events following vaccination are rare. Nowhere is officialdom’s minimization of vaccine risks more apparent than in these agencies’ position on vaccine-related deaths. The WHO, for example, states that “so few deaths can plausibly be attributed to vaccines that it is hard to assess the risk statistically.” Nevertheless, once regulators have deemed that a given vaccine is safe enough to be licensed and widely marketed, vaccine manufacturers are supposed to do just that—that is, continue to statistically assess a vaccine’s risks, including the risk of death—and regulators are supposed to carefully review the postlicensure data that pharmaceutical companies submit. A 2017 commentary by India-based physicians Jacob Puliyel and C. Sathyamala in the Indian Journal of Medical Ethics describes a shocking dereliction of duty on the part of regulators who were presented with vaccine data carefully tailored to obscure serious risks. Tackling concerns about infant deaths that have occurred following hexavalent vaccination in several European countries, the authors of the commentary show that GlaxoSmithKline (GSK) neglected to report to regulatory authorities that there was a statistically significant increased risk of sudden infant death in the four days after administration of its hexavalent vaccine—and the regulatory agency in question (the EMA) ignored the omission and accepted GSK’s apparently whitewashed data at face value.

Your article quotes physicians who practice in India, a country not regulated by the FDA or any other governing body on drug safety. In the US, side effects of any drug must be reported to the company in order for the company to adequately report those side effects to the FDA. Reporting can be done by several routes, the physician calls in an adverse event directly to the FDA, a physician or staff calls in the side effect directly to the company, patients or family members can report side effects directly to the FDA online, in essence bypassing the company and physician all together. Here is where most people fall short. You have to document the side effect. This means providing a list of all drugs that patients is on or had recently been on, the disease being treated and any association illnesses that patient may have had (example: people with kidney disease often have hypertension associated with the disease, this would be a disease associated with another disease. The first diseases caused the second disease making treatment option different vs someone with primary hypertension and no kidney disease).

If a side effect is reported by a company representative the company has 24 hours to report that side effect to the FDA. The FDA will forward paperwork to the physician within 24 hours after the report is filed. The physician will keep getting reports to fill out until the adverse event is documented with medical records. If a patient or patients family calls in the report, they will receive the same paperwork and must provide supporting medical records to support the claim. Hence, it required patients or family members to obtain the medical records of the patient. These records are always available and would be a violation of HIPPA if an office refused to provide them.

The FDA complies these side effect complaints and meets with manufacturers to discuss all side effects reported into the FDA. The FDA will determine if the reports are substantial enough to update the package insert. If it is determined that the drug in question or the class of drugs in question are indeed producing a known side effect, the specific drug and in rare instances the class of drugs will receive the PI update. By law, companies must send a Dear Dr. letter to all providers listing the specific change in the package insert. Representatives in the field have a two week time frame in which to follow up with providers, they carry addition letters with them to ensure the providers receive a copy of the change and answer questions as to the change. Providers can request additional information at that time on the change. This information is sent via medical affairs (not through field reps) by Board Certified physicians generally within their own specialty.

Vaccines are continually looked at for safety and necessity. Take for instance, polio vaccines. After roughly 1963, no one was given a polio vaccine or small pox vaccine. This is due to the fact that the WHO felt safe in determining that the disease had been eradicated and that the vaccine was no longer necessary. After that point, and as diseases became more understood, such as HPV, vaccines such as Gardasil were introduced. Patients with a family history of uterine cancer applaud the vaccine. Parents can determine if the vaccine is appropriate for their child or not. In our case, with an extensive family history of uterine cancer and all other forms of cancer, it was a given that our child would receive the vaccine.

To date because the process works so well, numerous drugs have been pulled from the market, or given limited distribution approval due to the process. COX-2 inhibitors are one example of this safety procedure. Tysabri is another. In the case of Tysabri patient advocates lobbied the FDA to bring the drug back on a limited distribution. Patients who had done very well on the drug and had no other options explained that the drugs was their only life line and explained that they understood the risks and would sign waivers to that effect.

On that note, please keep in mind that that a drug used in one disease often does not have the same side effects as in another disease. Tysabri is one of those drugs. In MS which is a demyelinating disease, reports came in that some patients went through rapid demyelination. Was it the drug for the disease? This same drug used in Crohns patients has seen no demyelinating in patients, most likely due to the fact that Crohn's is not a demyelinating disease. Is it the drug or the disease? Maybe it is both. That is what medical records submissions and PhD scientists at the FDA look at to determine if a drugs needs to be updated, restricted or pulled.

I hope that you publish this response. It is important that people understand the process of side effect reporting and the seriousness of reporting.