You are comparing to different things (in my opinion). IF that's the case, then should we charge higher rates for all preventable diseases? (obesity, diabetes, etc). What happened to ones bodily autonomy? Like you said its a slippery slope...now a experimental vaccine tomorrow an experimental medical device or treatment.
Just to jump in here, I was the one that brought up insurance mandates on vaccines and I absolutely agree it’s a violation of patient autonomy and a potentially a slippery slope.
That said, there are some differences. Using his example, smoking is ultimately conscious choice (not to delve into a debate about the nature of addiction, which I’m well aware of as it’s something I treat professionally- but there are many resources and treatments available for help quitting. The first attempts usually are not successful, but with persistence it can be done). Smoking either causes or negatively influences literally almost every medical condition there is and is a burden on the healthcare system.
Similarly, there are some insurers who will provide discounts to subscribers who exercise or who are overweight and lose weight. (I actually know someone whose insurance gave them a Fitbit to provide evidence they were exercising, so she put it on her dog’s collar and would play fetch, haha. Not sure how that works without the pulse data)
The difference between typical preventable diseases (or even treatable diseases i.e. hypertension, hypercholesterolemia, most bipolar cases, etc) and preventable
that are preventable with vaccines (particularly like COVID, especially in the context of an active pandemic) is that the latter can directly affect the health of others.
If you have diabetes, obesity, HTN, etc, your condition does not affect the health of others. One’s untreated diabetes or high cholesterol is not going to put our endocrine system or cardiac health at risk. On the other hand, in recent years we’ve had a number of localized pertussis (whooping cough) outbreaks in the US due to low DTaP/ Tdap vaccination rates in some communities (often high income areas with vaccination rates well below herd immunity, as low as 20%… rates lower than South Sudan). Despite the DTaP/ Tdap vaccines being 80-90% effective, when herd immunity is lost breakthrough cases become more prevalent. Plus some people have conditions that prevent them from being vaccinated and depend on herd immunity, thus putting them at even higher risk.
On the plus side pertussis can be treated with antibiotics. On the negative side pertussis effects are caused by a toxin that lingers for months and there is no way to get rid of it faster. Not having to use antibiotics if you don’t have to is ideal, especially considering rapidly increasing antibiotic resistance.
Similarly, not being vaccinated for COVID not only puts you at some level risk (relatively low for young people), but also others (some at very high risk), including those who are vaccinated. And perhaps most significantly,
more infection means a higher risk of mutations beneficial to the pathogen transmissibility, pharmaceutical resistance, and potentially resulting in a more deadly strain.
@Sir-Eat-a-Ton
I would push back calling the vaccines “experimental” is not accurate. Experimental means safety and efficacy have not been established- if you receive an experimental treatment there is not guarantee of either and there is a legal/ethical obligation to inform recipients of the treatment. Experimental also implies the subject is being closely monitored for data collection.
The vaccines have been through quite rigorous clinical trial phases, frankly in many ways more comprehensive than your average FDA approved pharmaceutical (each vaccine was tested experimentally on 10’s of thousands while most drugs are tested 500-2000 subjects). There is also a tremendous amount of ongoing “phase IV” studies that look at efficacy and side effects in the general population. The vaccines are
FDA authorized, safety and efficacy have been established. The limitation of the studies used for the vaccines’ EUA’s really comes down to the duration of monitoring, which was cut back in the clinical trials due to necessity. That said, it’s not typical for vaccine side effects to appear more than 2-3 maybe 4 weeks after dosing, especially considering unlike most other pharmaceuticals it’s not taken on a daily basis or targeting neurotransmitter or hormone receptors. IIRC when the EUA was issued on Pfizer we already knew it had at least 7-8 months of efficacy. I think the biggest question the FDA has at this point is how long is immunity maintained.
Under normal circumstances it usually takes 4-10 years to find potential drug candidates and narrow it down to one. 6-7 years to preform the three phases of clinical trials. Even with years of clinical trials it can take decades to discover side effects. Plus another 1-2 years for FDA approval. Now with hundreds of millions of doses administered and a reduction in case numbers, hospitalizations, and death corresponding to vaccinated communities, there’s little question the vaccines are safe and effective. The difference between an EUA and FDA approval is basically time but as mentioned in terms of vaccines historically, time has little relevance to safety. Either you get a negative reaction immediately to a few weeks after, or you don’t.
I would say however generally speaking mandating a pharmaceutical authorized under an EUA from the perspective of the public is inherently problematic considering your average person knows nothing about drug development and approval. In the case of the COVID-19 vaccine I have little concerns given the risk of the virus, intense clinical trials, and extensive ongoing research, especially considering how many people have received it. The FDA should be approving them as early Jan 2022 under accelerated review (meaning it’s prioritized over other applications, not that corners are being cut).
There are numerous of examples of drugs approved by the FDA that either have major trial limitations, insufficient informations/research, and/or have questionable clinical benefit… (Fortunately the COVID vaccine IMO doesn’t really fall into this category). Yet in many cases no one questions using these drugs.
Just to put things in perspective, several years ago a new insomnia drug with a completely novel mechanism of action was approved called Belsomra. Rather than blocking CNS histamine or activating GABA receptors, it blocks “orexin” receptors (something no medical professional knew about until this drug came out), inhibiting wakefulness. Their clinical trial had 500 subjects (incredibly small for such a common condition), monitored for up to 3 months. By comparison the Pfizer vaccine trials had almost 44,000 participants.
I had a discussion with a pharma company a few years ago about their dosing protocol of a new product (long-lasting injection administered monthly of and long established oral drug). The new injection had one-size fits all dosing, while the oral drug dosing could 8-24mg (up to 3x min dose). I had to speak to their chief of medicine involved in the study to find someone who knew what they were talking about. To determine the dosing they tested 3-4 180-200lb males in their 20’s, with the dose determined off some computer algorithm that calculated opiate receptor populations. They also claimed the injection was totally comparable to the oral version, except the average drug levels in the blood were 2-5x+ higher. Considering this is an opiate, risk of overdose is a concern, not to mention dose dependent side effects. Interestingly, in the past year they have added additional dosing regimens. They also removed the comparison of blood concentrations compared to the oral formulation from their drug information monograph.
And now we have this new Alzheimer’s drug, Aduhelm, that was recently FDA approved despite the advisory committee (independent of the FDA, they form an independent opinion- often more lenient than the FDA) opposing- leading to multiple resignations from the committee. It was approved despite insufficient evidence it actually slows cognitive decline, instead using a surrogate endpoint of reduction of amyloid plaque in the brain- which isn’t proven to improve cognition or slow mental deterioration. Basically the idea is throw it on the market and see if it works… which is quite experimental… at the cost of $60,000/year. As it is the two existing Alzheimer’s drugs slow disease profession by only a month or two… basically delaying the inevitable and dragging out the likely suffering. Not much clinical utility IMO.