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
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like