Why The FDA Should Stay Out of The Current Vaccine Debate
Updated
UPDATE: FDA Commissioner Scott Gottlieb has announced that he will step down from heading the agency.
Multiple media outlets are celebrating the comments of U.S. Food and Drug (FDA) Commissioner Scott Gottlieb who has taken it upon himself to weigh-in on the record vaccine legislation across the U.S. Currently, there are over 100 active bills in 30 states with over 50 aiming to expand and protect against several facets of coerced and mandatory vaccination. Gottlieb warned that states might “force the hand of the federal health agencies” if they continue to allow vaccine exemptions. “You could mandate certain rules about what is and isn’t permissible when it comes to allowing people to have exemptions,” he added.
In a perfect world, the FDA’s role, as their mission statement implies, should be that of an unbiased government body continually evaluating the scientific studies and clinical evidence relating to vaccines and drugs. Since the FDA should be regulating the vaccine industry, not threatening to use government force to push its products, Gottlieb’s statements rang highly inappropriate at best. What were the motivations for Gottlieb’s negligent, overreaching comments?
Multiple hearings surrounding vaccine legislation are currently taking place across America. In these hearings, valid criticisms and uncomfortable facts about vaccines, in addition to unarguable reasonsvaccine exemptions should be protected, are being laid out by medical professionals. Big Pharma talking points and mainstream media narratives used to justify legislation are being decimated through public testimony and citizen activism. Several states are poised to enact bills, rooted in personal liberty and medical common sense, to strengthen vaccine exemption statuses which would lend further legitimacy to a vaccine debate which the media and many within government positionsare desperately trying to avoid.
On the legal side, Gottlieb’s remarks have Constitutionally rooted problems as well. The New American writes, “One obvious problem with Gottlieb’s threats is that the federal government has no power to mandate vaccines or tell states what to do on the issue. In fact, according to the U.S. Constitution’s 10th Amendment, all powers not delegated to the federal government are retained by the states or the people. Of course, vaccine mandates are not listed as a federal power; therefore, as the Supreme Court has recognized, this is a state issue.“
Gottlieb’s poorly-timed comments come when his agency is under public scrutiny for its recent legal admissions. After failing to produce the clinical trials and safety studies relied upon to license both the flu and TdaP vaccines for use in pregnant women when presented with a FOIA request, the FDA was taken to court. Gottlieb’s FDA conceded, “Clinical studies for TdaP and inactivated influenza vaccines did not specifically enroll pregnant women.” The FDA legal response went on to admitthey “have no records responsive to your [plaintiff’s] request.” In short, the agency licensed the shots for use in pregnant women without the required scientific studies to ensure safety. In addition to the FDA licensing the flu and TdaP vaccines outside of law and their own policy, the agency is also actively promoting and marketing the flu shot to pregnant women, and is now threatening to step in and remove all U.S. state exemptions and legal barriers to all vaccines.
During the recent media-created Washington measles hysteria, Gottlieb appeared on CNBC’s “Squawk Box” to uncharacteristically push a pro-vaccine product agenda under the guise of preserving public health; a role normally reserved for the U.S. Centers for Disease Control and Prevention (CDC). Gottlieb inaccurately said that the Washington measles cases were a result of falling vaccination rates. Yet the CDC’s own data from Washington [and Oregon] show that MMR vaccinations rates have remained constant for over 20 years. Gottlieb did admit that he thinks “people have some casual fears about putting…a complex medical product into an otherwise healthy child.” When asked by the CNBC reporter why parents claim that their children developed autism or “something on the spectrum” right around the time they received their shots, Gottlieb blamed coincidence by saying:
“Children who are gonna display symptoms of autism and other developmental disorders, those start to manifest and become self-evident right around the time kids are getting vaccinated.”
The CDC’s schedule requires kids to get vaccinated from birth to 18 years. In other words, in Gottlieb’s world, during anytime “kids are getting vaccinated” is the window when a certain cross-section of them will naturally have “language and motor skills not developing properly.”
Watching the American opioid crisis continue to claim the lives of record numbers of people, a quadrupling in overdose deaths over the last two decades, has left onlookers weary of both drug companies and FDA who caused it. The current parallels of improper safety science and accelerated government endorsement with respect to vaccines can no longer be avoided.
In a 60 Minutes exclusive, CBS News reports:
“In 2001, after Dr. Kessler [FDA commissioner in the 1990s] left the agency, the FDA officially relabeled the powerful opioid OxyContin to be used for an ‘extended period of time’ by chronic pain suffers. Originally approved based on science that showed it safe and effective only when used “short-term”, the label was changed without adequate scientific study. “We don’t know whether the drugs are safe and effective for chronic use,” Kessler says. “The rigorous kind of scientific research the agency should be relying on is not there.” The right to market for the new indication was ultimately granted to a whole class of opioids.”
Kessler: “There are no studies on the safety or efficacy of opioids for longterm use.”
CBS Reporter: “But there’s a law that says that a drug cannot be promoted as safe and effective unless it’s proven to be safe and effective. But yet, with FDA sanction, these opioids are being used in that way that you say have not been proven.”
Kessler: “That’s correct. The rigorous kind of scientific evidence that the agency should be relying on is not there.”
Gottlieb released a statement to 60 Minutes admitting, “…we at the FDA include ourselves among those who should have acted sooner.”
Despite the reckless prescribing trends, lack of regulatory oversight and inept DEA enforcement, opioids were never mandated by individual states or the FDA . One can’t help see the tragic similarities between FDA’s unfounded opioid licensing for a new indication and the agency’s current full-court press to get shots, without adequate safety and efficacy testing, into not only pregnant mothers, but the rest of us as well.