Comments on GeriPal - Geriatrics and Palliative Care Blog: Are Drug Labels Missing Information That Patients ...

Thanks for highlighting this topic. It is always ...

2009-11-01T15:31:04.081-08:00

Thanks for highlighting this topic. It is always appalling to hear these things and I too have been attacked by the Lunest moth (hilarious!).

Another challenge is that the filed of decision sciences/medical communication hasn't fully agreed on the best way to communicate risk to patients. I think we are confident that absolute risks are better than relative risks but after that, it becomes more difficult and the research is mixed. How do you communicate rare but dangerous side effects in an unbiased way (one way or the other)? Also, Valerie Reyna's "fuzzy trace theory" of decision making argues that people make decisions based on the "gist" of the information rather than the "verbatim" numbers. Should these labels contain only the gist of the info? Who decides?

Obviously these drug companies need to be more honest but even honesty is hard in risk communication. Great topic.

Fascinating to learn! thanks for sharing and it is...

2009-10-30T10:41:02.926-07:00

Fascinating to learn! thanks for sharing and it is rather scary to not have all the needed info on the labels... and the Industry-FDA wars/compromise are a revelation to me.

Schwartz and Woloshin's article only scratches the...

2009-10-30T09:23:17.158-07:00

Schwartz and Woloshin's article only scratches the surface of the problems with medication labeling. Frankly, the package insert (which almost no one reads, anyways) is the least of the problems with how drug information is provided to patients and physicians. We have food labels that provide clear, templated information about what one is eating. Is it too much to ask to have the same for drugs, such as a simple fact sheet with key issues for consumers (e.g. major side effects for which to be vigilant, standardized dosing and frequency instructions, and so forth)?

Regarding Alex Smith's comment, drug labels are created in a process of negotiation between FDA and the drug manufacturer. There would clearly be less conflict of interest if the FDA would create the label without having to negotiate with industry about every word. Part of this would require greater funding of FDA to provide the human resources to take on such tasks. Unfortunately, previous attempts to use industry money to support FDA activities through the Prescription Drug User Fee Act (PDUFA) have resulted in their own conflicts of interest, whereby the FDA is beholden to industry for its funding. Thus, a better system needs to be devised to get the FDA the resources it needs to protect the public health while avoiding the conflicts of interest that have resulted in questionable decisions.

What is disturbing is the lunesta moth - I've had ...

2009-10-29T22:36:19.973-07:00

What is disturbing is the lunesta moth - I've had dreams about that thing attacking me. No wonder why patients didn't have improvement in next day alterness.

Here is a link to the example drug box on lunesta. No moth, just good infomation.

Disturbing. Why doesn't this information make it ...

2009-10-29T20:54:44.446-07:00

Disturbing. Why doesn't this information make it on the label? I assume the pharmaceutical industry somehow supresses it. I don't know enough about how they influence the FDA. Does anyone?