Ethical question about answering patient concerns regarding vaccines

masterofmonkeys

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Odd place for this I know. But 1) this is the subforum I know best. 2) pediatricians are cultish about this 3) Psychiatrists deal with ethics and think about it a lot more than most other specialties.

So I haven't yet been put in the position of being asked my personal opinion on various vaccinations. But I know it's a matter of time.

I am not on the autism/mercury/vaccine bandwagon, not by a long shot. In fact, I kinda despise them as they take attention away from the very serious problem of poor safety studies and autoimmune/neurologic sequelae from vaccines.

But I'm a victim of vaccine injury myself (brachioplexopathy). And the research on this as a result of vaccination is very, very solid. We have epidemiologic evidence, challenge-rechallenge studies, and have even elucidated the mechanism by which it happens.

The same is true for other neurologic sequelae as well as autoimmune dysfunction secondary to vaccines.

In the case of specific antigen-caused sequelae, it's a process not unlike your basic immune cross-reactions such as Reiter's, or ag-ab complex deposition as in post-streptococcal glomerulonephritis/rheumatic fever. If the pathogen can cause an immune cross-reaction (which the flu, adenovirus, hep B, and others all do), then the vaccine can cause it as well.

In the case of aduvant issues, it has to do with nonspecific activation of Th1 and suppression of Th2 cells, among other changes in the immune/inflammatory system.

What we don't have is anything approaching good numbers regarding incidence and prevalence of these problems. While an efficacy arm of a trial may last for years. Side effect data is only tracked for 5-14 days. Which isn't even time to mount a full immune response. My syndromee only fully matured into its current, debilitating state over the course of 6 weeks. At 5 days I was still 'extreme pain at the injection site'. Moreover, with regard to adjuvant-related sequelae, it is conceivable that since adjuvants have been shown to have years-long effects on immune/inflammatory activity, that sequelae could pop up anywhere within this time frame.

That problem aside, side effect data is horribly codified into broad, almost useless categories. Neurogenic pain at 5 days is a different animal than a bruise at 5 days. Yet they're coded the same.

Moving on, post-marketing surveillance is pathetic. CDC estimates that only 10% of adverse reactions get reported. FDA thinks it's closer to 1%. And again, the groups are terrible. And there's no followup. There are reports of patients with pain so bad they can't move their limb at 10 days post-injection. With no followup. Coded as 'non-debilitating'. Or anaphylaxis requiring intubation. Coded as 'non-life threatening'. What? Really???

So the truth is, I have no idea how safe or unsafe most vaccines are. But I do know that they do hurt, cripple, and kill. We all know that.

With a highly contagious, pervasive illness with high morbidity it's probably a pretty decent bet (but still a bet) that the risks of the vaccine are worth it.

But what about something like Hep B, the vaccine that crippled me, given that I have no risk factors for contracting it? It doesn't take a very high rate of serious side effects to tilt the risk-benefit analysis away from the vaccine.

Or HPV, for which the vaccine will only prevent 70% of cervical cancers (which will actually grow less over time as other genotypes gain a selective advantage), and after which you'll STILL need to get regular pap smears, which are far more effective at preventing cervical cancer? Doesn't take a large number of vaccine injuries there either.

I realize the professional bodies that govern us tell me I'm supposed to rabidly champion vaccination for everything from tetanus to chickenpox to the common cold. I also realize that as a scientist, a person of conscience, and a physician who chooses to use his brain, that I can't always do that. Which puts me in a bit of a bind.

I laid out the evidence behind my position not to convince anyone else (although I'd be happy if it did convince other physicians we need better vaccine safety data), but rather to show that this comes from a reasoned perspective borne out of a lot more effort and education than most of us apply to the issue. Given that, what's your take on the issue? How do I handle it gracefully and ethically?
 

loveoforganic

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I'm obviously not the type of person you were looking to answer this, but what the hay.

I'd answer pretty genuinely, but your exact response is going to depend on the cognitive level of the patient. The explanation above would obviously be bordering on gibberish to the majority of patients.

"Any vaccine comes with a certain level of risk. Beside the fact that a vaccine, depending on the type, actually has a chance to cause full blown infection, there are other possible averse reactions that could lead to side effects such as chronic pain and motor movement dysfunction. The possibility of this happening is possibly underreported, but still low."

I probably wouldn't go into risk/benefit analysis, just because I think you'd be setting yourself up for a lawsuit if you told a patient he was low risk for hepatitis and ended up contracting it. It all comes back to the physician with the "biased anti-vaccine agenda due to his own unrepresentative experience."

Just a premed though, so take it for what it's worth :p
 

RGMSU

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I have no problem with data, but I hate to see the kind of hysteria develop that often accompanies drug side effect studies. As a provider, there is the ethical obligation to pursue vaccinations for oneself to prevent spreading to patients. I also believe it to be unethical (or at least unwise) to spook patients into not pursuing a vaccine based on reactions that, while statistically significant, are still quite unlikely. It is true that, as a matter of probability, one could debate whether a patient would be more likely to contract the illness without the vaccine versus suffer a significant side effect with the vaccine. I would tend to err on the side of being preventative, when possible, acknowledging that side effects are possible but not likely. It is an assumed risk, to be sure, but perhaps less so than not getting the vaccine, depending on the illness. Particularly in the case of potential pandemic situations, eg, H1N1, I believe there is a moral mandate to be even less concerned about the occasional side effect in light of the "greater good." Of course, unlike you, I have never had a severe reaction to a vaccine, so my perspective is different. I do think that the provider has the responsibility to inform a patient about risk, though. I would not have a problem with telling a patient that a reaction would be highly unlikely, so as to encourage them to take the risk if I thought the potential benefit outweighed the risk. I'm apparently relatively pro-vaccine here though. I believe you and I would tend to look at statements differently based on experience. You say HPV is effective against ONLY 70% of cervical cancers viewing that as glass half empty, where I would tend to view it glass half full. HPV is only ineffective against 30% of cervical cancers. Respectfully, I would say that how much any of us allows our own personal experiences to impact patient decisions is an ethical concern.
 
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kugel

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I like RGMSU's response, but I would add one other topic to the discussion:

You know, every treatment has possible side effects and you have to decide whether the (usu low) risk of SE's is enough to keep you from getting the treatment. But vaccines are a little different. Let me ask you something. How much responsibility do you think you have to avoid giving this disease to someone else - when you have no idea how susceptible he may be to actually dying from that disease - and you have no way of knowing whether he had a condition which actually prevented him from being able to get this vaccine. If you feel you have any responsibility to help prevent others from getting sick, then you have to include that into your decision about whether to get this vaccine. In any public health campaign like this, it's true that a few people will get seriously hurt - but the point of the campaign is that vastly more people will avoid serious harm. This is partly about your responsibility to the rest of society as well as your own risk/benefit calculation. I can tell you that I'm getting it, I'm asking all my family to get it, and I'd prefer that you get it, too. But ultimately, the decision is yours.
 

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You also forget that the HPV also covers genital warts. A vaccine to prevent an std is phenomenal. People already have horrible sex hygiene, plus rape victims aren't always raped by the person who uses a condom and is disease free. Vaccination is a step in the right direction of staving it off.
 

masterofmonkeys

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I like RGMSU's response, but I would add one other topic to the discussion:

In any public health campaign like this, it's true that a few people will get seriously hurt - but the point of the campaign is that vastly more people will avoid serious harm.

Again, one of my major concerns is that as we vaccinate for diseases with ever lower incidence/prevalance, as well as morbidity/mortality, it doesn't take a huge rate of serious side effects to seriously skew this whole concept.

Take Hep B as an example. 3 out of 100,000 children developed this infection acutely in pre-vaccine days. Clearance rate of the infection is somewhere around 70% in the pediatric population as a whole. Which drops the chronically infected/carrier rate to .9 out of 100,000. 40% of these will develop cirrhosis or hepatocellular carcinoma. Which drops the rate of serious morbidity to .36 out of 100,000.

Which means if the vaccine has a serious complication rate of 1/300,000, the 'we crippled you but saved a lot more people' argument isn't true anymore.

I don't doubt that I'm more likely to scream about the sky falling with regard to vaccines than other people. But I also think that most physicians don't even think about the people who have had their lives destroyed by vaccines when they think about these issues. I don't think most of them think about the myriad ways in which a vaccine could harm an individual through biologically plausible, sensible, and proven pathways.
 
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RGMSU

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You could make this argument about hep b for the general population. It's not particularly common. Of course, without vaccination, it would become more common. Probably there have been generational lifestyle changes that could make it more common in the future as well. For healthcare workers, though, hep b vaccination takes on a whole new significance. My medical school required me to be vaccinated for hep b, and I have seen no evidence that this is not required by other medical training programs for medical professionals. I'm not sure how high the incidence of exposure to hep b is for a medical professional either. But, again, with a medical professional, it is assumed (and usually required) that you will be vaccinated for whatever you can be vaccinated for so as not to inadvertently infect a patient.
 

kugel

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But I also think that most physicians don't even think about the people who have had their lives destroyed by vaccines when they think about these issues. I don't think most of them think about the myriad ways in which a vaccine could harm an individual through biologically plausible, sensible, and proven pathways.

Perfectly valid point. Honestly, I don't think most prescribers think about just how likely SE's are for the vast majority of tx's prescribed, incl vaccines. Ive NEVER had a PCP discuss any SE's - period. Even during the 37 yrs of my life before I was an MD. Don't know anyone in my family who's ever had SE's discussed before one occurred. I think they know about the SE's, but don't discuss them with patients.

An extreme example:
I was prescribed Cardizem for a 1-day run of A-Fib while in the hospital with something else very serious. Never had another day of A-fib. 6 months after recovery from the other illness (1 year after my 1 day of A-Fib), I asked the cardiologist (again) when/how he planned on having me stop the Cardizem. He told me, "You shouldn't. Not because of the A-Fib, but because you're a bit overweight and you'll probably eventually develop HTN sometime in your life and the Cardizem is a good drug. So just keep taking it so that when you develop HTN you'll already be treated." I asked him, "Really? You want me to stay on a powerful drug with multiple possible side effects, for the rest of my life, just in case I might develop a disease for which this drug is not the first-line choice? That's really your plan?" He answered, "It's a perfectly safe drug. Do you have any side effects (fist time he'd asked this)? No? Then you probably won't get any."
:wow:
 
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