A favorite tactic of anti-vaccination ideologues is the "informed consent" gambit. By exaggerating adverse effects of vaccines, anti-vaccinationists can scare patients or parents into refusing immunization for themselves or their children. SFSBM Board chairman David Gorski calls this tactic "misinformed consent," and rightly so.
It is therefore with skepticism that I view House Bill 1978 and Senate Bill 1870 (the bills are identical) recently introduced in the Minnesota Legislature. The bills have several suspicious provisions which seem tailor-made to raise unfounded parental alarm.
First, the bills require health care providers (physicians, PAs and APRNs) to give patients, or their parents, vaccine information statements from the CDC. No problem there. But the providers must also give them
information provided by the manufacturer with the vaccine, including the package insert . . .
Why? Well, we don't know, because (unlike many other bills) there is no research summary giving constituents and other legislators any rationale for, or research underlying, the bills. But, we do know that package inserts for vaccinations are designed to give the provider information, not patients. It is often highly technical and sometimes unintelligible for those without medical training. And, of course, subject to misinterpretation. True, the inserts are available to the public on the FDA's website, but it seems odd that the bills' supporters would require package inserts in addition to the CDC's handouts, which are specifically designed for public consumption.
Second, the bills require any health care provider who
is made aware that a patient has or may have had an adverse reaction to a vaccination must report that adverse event to the Vaccine Adverse Events Reporting System [and must do so] immediately after becoming aware of an adverse event or a potential adverse event . . .
VAERS is a national vaccine safety surveillance program overseen by the CDC and FDA. It is designed to identify reported adverse events that need further study. VAERS has been abused by anti-vaccinationists who are given to treating VAERS as if it were a database proving causation, not suggesting a correlation which may, or may not, warrant further study. Unfortunately, what might have been a valuable research tool has been rendered almost worthless by over-reporting.
VAERS encourages, but does not require, reporting of any clinically significant adverse event (not "potential" adverse event) that occurs after the administration of a vaccine. The National Childhood Vaccine Injury Actrequires health care providers to report only those adverse events listed by the manufacturer as a contraindication to subsequent doses of the vaccine and events listed in the VAERS Reportable Events Table occurring within a specified time period after vaccination. Minnesota would go beyond these requirements by making providers report any event that "may" have been a "potential" adverse reaction, even if it is not listed or, presumably, not even clinically significant. And why? If the CDC and FDA don't deem certain events worthy of reporting, why does the State of Minnesota care?
Third, the bills prevent retaliation by an employer or disciplinary action by a professional licensing board
for providing a patient or a patient's parent . . . with the health care provider's medical opinion on the benefits or potential side effects of a vaccination or for reporting an adverse event to VAERS . . .
Of course, no provider is going to be disciplined for giving patients the CDC's vaccination information sheets or following the American Academy of Pediatrics immunization advice. So who is this designed to protect? My guess is irresponsible practitioners who give substandard immunization advice, like "alternative" vaccination schedules, or stoke vaccination fears. How do the bills accomplish this? By removing the usual standard of care for medical advice as a measure of a provider's performance so that any "opinion" or VAERS report, no matter how baseless, would be beyond the reach of discipline. This is part of a disturbing trend in legislation designed to allow substandard medical practice, such as treatment of "chronic Lyme disease" and "right to try" and "health care freedom" laws. These laws remove good science as a bedrock underlying the medical standard of care so that unscrupulous practitioners can take full advantage of patients without fear of consequences.
By cloaking this legislation in the seemingly benign language of "informed consent" and mandated VAERS reporting, unsuspecting legislators may take these bills as simply reinforcing good medical practice. Not true. The state does not improve patient care by substituting sound medical advice on an important public health issue with fear mongering about vaccines.
I was wandering the Oxford English Dictionary and found a new definition for worthless: "Noun. A clinical efficacy trial with no blinding, no placebo, and only subjective endpoints derived from patien...
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