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Merck Says Shingles Vaccine Approved

Rating

2 Star

Merck Says Shingles Vaccine Approved

Our Review Summary

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%

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

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.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story provides quantification of benefits in relative terms only.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

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.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

Although the story mentions some research, it does not adequately describe the strength of the existing evidence.

Does the story commit disease-mongering?

Satisfactory

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%

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

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.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

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.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

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.

Does the story establish the true novelty of the approach?

Satisfactory

The story mentions that the shingles vaccine is just a variant of an existing chickenpox vaccine.

Does the story appear to rely solely or largely on a news release?

Not Satisfactory

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.

Total Score: 4 of 10 Satisfactory

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