Post by Amtram on Feb 25, 2014 18:29:51 GMT -5
Skeptical Raptor mostly blogs about vaccines, but has a very useful post about what the information in your Package Insert really means. I usually like to point out that the adverse events appear first because of their severity, not because of their frequency, and that it's important to look at the statistics for adverse events and side effects versus placebo, but this goes into much more detail.
There's more information in the post. In the case of psychiatric medications, we're already scared and worried about side effects. After you go through the scientific information and get how the PI is set up, it usually makes you feel a lot more confident about getting treatment.
To a real evidence-based (or science-based) physician, the only useful information in PI for vaccines are (in no particular order of importance):
Clinical pharmacology. Knowing this information helps the scientific minded (not a skill set well known in vaccine deniers) how the drugs work. By understanding this section, you begin to comprehend how a drug may treat a disease, but also how it probably isn’t related to a mythical adverse event. For example, knowing how immunizations work, you will realize that intramuscular injections are a perfectly scientific method of inducing an immune response, that there is no logical reason to believe an injection would cause a neurological disorder, and other silly myths. But pharmacology is very hard to understand, so most people ignore it. I wouldn’t.
Contraindications. There are very few contraindications in vaccines. But the ones that do exist are quite serious. For example, the aforementioned sensitivity to egg proteins in flu vaccines. Or yeast sensitivity for Gardasil. Physicians are very aware of these issues, as are most places, like pharmacies, that do vaccinations.
Warnings. These are adverse events that have evidence supporting their causal association with the drug or vaccine. As opposed to the adverse reactions section, which tends to be abused by vaccine deniers, this section is where solid, repeatable scientific data is located. The FDA, by regulation, can mandate a change in the PI to include new warnings as evidence arises. Not a single PI for vaccines mentions autism as a “warning.” Not one.
The most misinterpreted misused section of the PI insert is “Adverse Reactions.” The FDA states that the section should include events “for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.” The key word is “believe”, instead of based on evidence. And frankly, anything with serious evidence would be in the Warnings section, so the Adverse Reactions section is a laundry list of observed events that probably have nothing to do with the drug (or vaccine) but remain there so that the pharmaceutical company is covered in case of a lawsuit. Yes, pharmaceutical companies are constantly frightened of litigation, and the package insert is often the first line of defense against those frequent lawsuits. But we digress.
Clinical pharmacology. Knowing this information helps the scientific minded (not a skill set well known in vaccine deniers) how the drugs work. By understanding this section, you begin to comprehend how a drug may treat a disease, but also how it probably isn’t related to a mythical adverse event. For example, knowing how immunizations work, you will realize that intramuscular injections are a perfectly scientific method of inducing an immune response, that there is no logical reason to believe an injection would cause a neurological disorder, and other silly myths. But pharmacology is very hard to understand, so most people ignore it. I wouldn’t.
Contraindications. There are very few contraindications in vaccines. But the ones that do exist are quite serious. For example, the aforementioned sensitivity to egg proteins in flu vaccines. Or yeast sensitivity for Gardasil. Physicians are very aware of these issues, as are most places, like pharmacies, that do vaccinations.
Warnings. These are adverse events that have evidence supporting their causal association with the drug or vaccine. As opposed to the adverse reactions section, which tends to be abused by vaccine deniers, this section is where solid, repeatable scientific data is located. The FDA, by regulation, can mandate a change in the PI to include new warnings as evidence arises. Not a single PI for vaccines mentions autism as a “warning.” Not one.
The most misinterpreted misused section of the PI insert is “Adverse Reactions.” The FDA states that the section should include events “for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.” The key word is “believe”, instead of based on evidence. And frankly, anything with serious evidence would be in the Warnings section, so the Adverse Reactions section is a laundry list of observed events that probably have nothing to do with the drug (or vaccine) but remain there so that the pharmaceutical company is covered in case of a lawsuit. Yes, pharmaceutical companies are constantly frightened of litigation, and the package insert is often the first line of defense against those frequent lawsuits. But we digress.
There's more information in the post. In the case of psychiatric medications, we're already scared and worried about side effects. After you go through the scientific information and get how the PI is set up, it usually makes you feel a lot more confident about getting treatment.