The Drug and Gadget Regulation Weblog is intentionally apolitical. Our goal is to assist the protection of prescription medical product legal responsibility litigation, and we acknowledge that the political beliefs of our supposed viewers undoubtedly differ extensively.
However one of many foundational grounds of our protection efforts is that the FDA, in its approval and subsequent regulation of prescription medical merchandise, does so via expert consultants impartially evaluating well-conducted analysis and sufficiently supported information. The company’s adherence to the scientific methodology and scientific ideas is crucial to our purchasers as they develop, and search regulatory approval for, new prescription medical merchandise, in addition to modifications to current labeling, designs, and manufacturing processes. In litigation, the FDA’s adherence to the scientific methodology and scientific ideas is the underpinning of our purchasers’ two strongest defenses – preemption and Rule 702/knowledgeable admissibility. If the FDA (and different federal businesses such because the CDC, NIH, and ACIP) ever deserted, or have been perceived to have deserted, the scientific methodology in its decision-making, each regulatory and litigation chaos fairly probably would end result.
That’s why we’re disturbed by indications that anti-vaccine crusader and all-around science denier Robert Kennedy, Jr. could be given authority over the FDA – and allowed to “go wild” over “well being care” and “medicines.” Here’s a video hyperlink to a latest Trump speech, and right here is our transcript restricted to the related statements:
Robert F. Kennedy cares extra about human beings and well being and the surroundings than anyone, and he’s gonna be absolute, having him is such an important honor, I’ve been buddies of his for a very long time, and uh I’m gonna let him go wild on well being, I’m gonna let him go wild on the meals, I’m gonna let him go wild on medicines . . . .
Video hyperlink at 0:06-0:34 (emphasis added).
To us, and to others, this growth is trigger for important concern. And don’t simply take our phrase for it. Right here’s an excerpt from Science journal:
The previous presidential candidate, who dropped out in August after which joined Trump’s marketing campaign, advised supporters that “President Trump has promised me … management of the general public well being businesses.” He ticked off “HHS and its subagencies, CDC [Centers for Disease Control and Prevention], FDA, NIH, and some others, after which additionally the USDA [U.S. Department of Agriculture],” in line with a video that CNN reported on Tuesday.
* * * *
Public well being researchers are alarmed, particularly given Kennedy’s opposition to vaccines. “I can’t think about anybody who could be extra damaging to vaccines and using vaccines than RFK,” College of Minnesota epidemiologist Michael Osterholm advised CNN.
* * * *
Kennedy additionally has plans to overtake the businesses inside HHS. At FDA, for instance, which he faults for failing to approve controversial therapies comparable to ivermectin for COVID-19 and psychedelic compounds for psychological well being circumstances, he’s stated staffers ought to “pack your baggage.” At NIH, he desires to shift funding from infectious illness analysis to continual illnesses. . . .
Quite a few critics of Kennedy have weighed in with issues. Youngsters’s Hospital of Philadelphia vaccine knowledgeable Paul Offit advised CNN Kennedy is a “science denialist.” Even Jerome Adams, who was surgeon normal throughout Trump’s presidency, stated at a gathering this week that if Kennedy discourages individuals from getting vaccines, “I’m frightened in regards to the influence that would have on our nation’s well being,” financial system, and safety.
Science, “Researchers ‘in a state of panic’ after Robert F. Kennedy Jr. says Trump will hand him well being businesses” (embedded hyperlinks in unique article).
An equally latest New York Instances article makes comparable factors:
Mr. Kennedy has lately promoted unproven theories in regards to the risks of pharmaceutical therapies, together with childhood vaccinations. His potential position in working America’s public well being paperwork has animated his supporters, however alarmed medical professionals.
* * * *
[RFK Jr.] stated he would “reorient” the N.I.H. “in order that as an alternative of growing medicine” or “serving as an incubator for pharmaceutical merchandise,” the group would as an alternative “be determining what’s inflicting these autism charges and autoimmune illnesses and neurodevelopmental illnesses.”
“R.F.Okay. Jr. Stated Trump Promised Him Management of Public Well being Businesses,. . . .” (Oct. 30, 2024). Way more commentary is out there on-line to anybody who’s .
Why the trigger for concern, and for vaccines specifically? Robert Kennedy Jr. has repeatedly in contrast vaccination to what the Nazis perpetrated within the Holocaust:
Kennedy had referenced [Anne] Frank, a baby who died in a Nazi focus camp, whereas talking in entrance of the Lincoln Memorial on Sunday at an anti-vaccine rally. “Even in Hitler’s Germany, you can cross the Alps to Switzerland. You possibly can cover in an attic like Anne Frank did,” stated Kennedy, a longtime opponent of vaccines who has unfold unsupported claims about pictures proven to guard in opposition to covid-19.
* * * *
It was not the primary time Kennedy has invoked the Holocaust in reference to vaccines. In 2015, he stated of vaccinations: “They get the shot, that night time they’ve a fever of 100 and three, they fall asleep, and three months later their mind is gone. It is a holocaust, what that is doing to our nation.”
Washington Publish, “Robert F. Kennedy Jr. apologizes for saying the unvaccinated have much less freedom than Anne Frank did.” Nor does RFK Jr. have any background in science or in drug regulation (past his personal admitted unlawful use).
All through its historical past – earlier than and after COVID-19 − this weblog has been a steadfast supporter of vaccination, in explicit, and the scientific methodology usually. We consider that “the elimination of communicable illnesses via vaccination” is “one of many biggest achievements of public well being within the twentieth century.” Bruesewitz v. Wyeth LLC, 562 U.S. 223, 226 (2011).
We don’t like how our purchasers, as “Massive Pharma,” are continuously villainized for political functions. Nor will we like alliances between politicians and the plaintiffs’ bar – together with, however not restricted to, RFK, Jr.’s personal affiliations with p-side mass tort companies − that perpetuate the “tort tax” surcharge that mass tort litigation provides to the fee (and thus the costs) of our purchasers’ lifesaving merchandise. Drug (and system) growth merely isn’t low-cost:
It could possibly take billions of {dollars} for a producer to get a brand new drug from the laboratory onto the pharmacy shelf. In a examine from the London College of Economics, the median price was decided to be $985 million. Variations can typically happen with dearer therapeutic lessons. For instance, most cancers and immunomodulator medicine have had a median growth price of as much as $2.7 billion.
“FDA Drug Approval Course of” (medicine.com final up to date 8/14/2024).
However for all of the villainization, and all of the coerced MDL settlements, the plaintiffs’ bar has by no means severely tried to destroy the FDA, CDC, NIH, and so forth. as scientifically based mostly organizations. That this risk is being floated is one thing we discover profoundly disturbing. The precedent such a growth would set, and the injury it will do, may effectively be irreparable. If the scientific guardrails which have ruled American public well being coverage for a century are breached – and the general public servants who’ve administered them “pack their baggage” and go away – restoration of the establishment ante could be extraordinarily troublesome, if not unattainable.
