This is a story about FDA approval of the shingles vaccine by Merck. The story, which appears to be geared towards investors, does a fair job of covering the announcement, but is flawed in several ways.
Although the story mentions some research, it does not adequately describe the strength of the existing evidence. Other than to mention that patients suffered a slightly higher number of serious side effects in clinical trials compared to placebo, the story does not mention harms. This is not sufficient. The story provides quantification of benefits in relative terms only. The story does not mention any alternatives. Although there are no other treatments that prevent shingles, there are effective treatments if the condition is found early. The story only quotes two FDA officials and one Merck employee. This is not sufficient. The story should have quoted clinicians or researchers who could provide some additional perspectives. The story appears to have relied on an FDA press release and accompanying press conference as sources of information (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01378.html).
The story clearly states that the vaccine has been recently approved by the FDA. The story does not discuss whether the vaccine will be widely available or when it will be available. The story mentions the cost of the vaccine and comments on the potential billion dollar a year windfall for Merck as a result of implementing widespread screening. However, the story does not discuss the potential cost to the consumer. Since most of the affected are people over age 60, insurance coverage for the vaccine may vary depending on the plan. Although Medicare Part D will likey cover some of the costs, it remains to be seen how much of the costs will be put on the recipients in their coverage.
By accurately describing the incidence and seriousness of shingles, the story avoids disease mongering and the story mentions that the shingles vaccine is just a variant of an existing chickenpox vaccine. However, the description of the condition is incomplete. The disease is self limiting and resolves over time. The incidence of postherpetic neuralgia (PHN – a chronic pain syndrome associated with shingles) is less than 10%
The story mentions the cost of the vaccine and comments on the potential billion dollar a year windfall for Merck as a result of implementing widespread screening. The story does not discuss the potential cost to the consumer. Since most of the affected are over age 60, insurance coverage for the vaccine may vary depending on the plan. Although Medicare Part D will likey cover some of the costs, it remains to be seen how much of the costs will be put on the recipients in their coverage.
The story provides quantification of benefits in relative terms only.
Other than to mention that patients suffered a slightly higher number of serious side effects in clinical trials compared to placebo, the story does not mention harms. This is not sufficient.
Although the story mentions some research, it does not adequately describe the strength of the existing evidence.
By accurately describing the incidence and seriousness of shingles, the story avoids disease mongering. However, the description of the condition is incomplete. The disease is self limiting and resolves over time. The incidence of postherpetic neuralgia (PHN – a chronic pain syndrome associated with shingles) is less than 10%
The story only quotes two FDA officials and one Merck employee. This is not sufficient. The story should have quoted clinicians or researchers who could provide some additional perspectives.
The story does not mention any alternatives. Although there are no other treatments that prevent shingles, there are effective treatments if the condition is found early.
The story clearly states that the vaccine has been recently approved by the FDA. The story does not discuss whether the vaccine will be widely available or when it will be available.
The story mentions that the shingles vaccine is just a variant of an existing chickenpox vaccine.
The story appears to have relied largely on an FDA press release and accompanying press conference as sources of information.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01378.html
The FDA news release may be true but incomplete. For a full understanding one would need to read the minutes of the advisory committee.
Systematic, Criteria-Driven
We’ve written about the hype of liquid biopsies for years (see link in comment below). And now this…. https://www.statnews.com/2022/01/12/medicare-shouldnt-cover-liquid-biopsies-early-cancer-detection/
Case counts still matter. “(There) are stories that may not be told adequately if only hospitalizations and deaths are emphasized.” @garyschwitzer interviewed by @dbauder of @AP. https://apnews.com/article/omicron-changing-news-outlets-covid-data-da9272f7c4c8a109c3bfb56bed9e9c76
My friend Gary @garyschwitzer wrote to his city council representative in a Minnesota town about a Viva Las Vegas event scheduled for January.
The response he got seems to perfectly capture where we are now.
https://www.healthnewsreview.org/2021/12/2021-ends-with-covid-craziness-in-sports-and-politics/
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