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Gold mine or dumpster dive? A closer look at adverse event reports

All informed health decisions are based on an evaluation of expected risks and known benefits. Nothing is without risk. Drugs can provide an enormous benefit, but they all have the potential to harm. Whether it’s to guide therapy choices or to ensure patients are aware of the risks of their prescription drugs, I spend a lot of time discussing the potential negative consequences of treatments. It’s part of my dialogue with consumers: You cannot have an effect without the possibility of an adverse effect. And even when used in a science-based way, there is always the possibility of a drug causing either predictable or idiosyncratic harm.

An “adverse event” is an undesirable outcome related to the provision of healthcare. It may be a natural consequence of the underlying illness, or it could be related to a treatment provided. The use of the term “event” is deliberate, as it does not imply a cause: it is simply associated with an intervention. The term “adverse reaction,” or more specifically “adverse drug reaction,” is used where a causal relationship is strongly suspected. Not all adverse events can be be causally linked to health interventions. Consequently, many adverse events associated with drug treatments can only be considered “suspected” adverse drug reactions until more information emerges to suggest the relationship is likely to be true.

Correlation fallacies can be hard to identify, even for health professionals. You take a drug (or, say, are given a vaccine). Soon after, some event occurs. Was the event caused by the treatment? It’s one of the most common questions I receive: ”Does drug ‘X’ cause reaction ‘Y’?” We know correlation doesn’t equal causation. But we can do better than dismissing the relationship as anecdotal, as it could be real. Consider an adverse event that is a believed to be related to drug therapy: (more…)

Posted in: Epidemiology, Pharmaceuticals

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Another Anti-Vaccine Book

I was asked to review the book Make an Informed Vaccine Decision for the Health of Your Child by Mayer Eisenstein with Neil Z. Miller. Fortunately my public library had it so I didn’t have to buy a copy. Reading it was a painful déjà vu experience. I can honestly say it met all my expectations: I expected that its concept of “informed decision” would equate to deciding not to vaccinate, and that it would rely on the same tired old fallacious arguments that have been heard before and rejected by knowledgeable scientists. The only thing that surprised me was a warning/disclaimer statement that admitted

this book tends to find fault with vaccines, therefore readers are advised to balance the data presented here with data presented by “official” sources of vaccine information, including vaccine manufacturers, the FDA, CDC and World Health Organization.

The fact that the book omitted all that balancing data undermines its pretense that it is intended to help readers make a truly informed decision.

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Posted in: Book & movie reviews, Vaccines

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