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Drug Promises to Restore Sensation After Dental Visit

Rating

2 Star

Drug Promises to Restore Sensation After Dental Visit

Our Review Summary

This article on OraVerse, a drug recently approved to reduce the duration of numbness following local dental anesthesia, appeared in the business section of the New York Times. It reflects the interests of readers who follow medical companies or markets, not those who might use the product.

Viewed from the perspective of a reader interested in personal health, however, the article falls far short of expectations.

  • The story doesn’t question the product’s basic premise: That the duration of post-anesthesia numbness is a problem that needs a solution.
  • The reporter interviewed only people with a financial interest in the drug.

While the reporter appears to be diligent by several times raising questions about the need for or function of the drug, he allows only sources associated with the company to respond to them. This creates the impression of diligence without actually performing it.

Because there is no independent voice in the piece, the report proceeds without a reality check. The self-interested sources’ claims that children risk damaging their tongues needs a disinterested response. Same for the assumption that someone getting a cosmetic procedure will be more likely to want to reduce the duration of their numbness than someone who had a filling.

Because this story was not reported from a health consumer’s point of view, it fails to raise the most serious question: risk vs. benefit. If OraServe raises heart or blood vessel event risk even slightly, does its benefit justify that risk?  

If viewed purely as a business story, the article would still benefit from an independent voice–someone who can let investors or market watchers understand the real potential for this drug.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The article reports the company will sell the drug to dentists for $12.50 per injection. It also says some dentists will mark it up to make profit.  How big that markup may be is the key question for consumers. 

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

Satisfactory

The article does a good job describing the clinical trials and the results.  Kudos for including both relative and absolute differences.

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

Not Satisfactory

The article says that when used for high blood pressure the drug can cause heart attacks and occlusion of blood vessels in the brain.

But the report does not challenge the drugmaker’s claim that those side effects would not apply for this use of th drug. And again, since the data is unpublished it is a leap of faith to accept this conclusion.

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

Not Satisfactory

Claims about the drug’s effects are based on clinical trials that led to FDA approval. But these reports are unpublished and the studies were conducted by the drugmaker at least in part by paid consultants to the company. So readers are forced to accept the company’s point of view.  Without access to the source documents or data, the statements cannot be verified.  

Does the story commit disease-mongering?

Not Satisfactory

The article implictly accepts the drug-maker’s premise that lingering numbness after dental anesthesia is a condition that requires treatment. One could easily find medical sources who disagree.  But the Times didn’t – or at least they didn’t quote them. 

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

Not Satisfactory

The reporter interviewed only company executives and dentists who consult with the company. No independent medical sources were consulted. 

Given the questionable premise of the product, this is a remarkable omission.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The article does not seriously explore the treatment "option" of not having the injection.

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

Satisfactory

The article says the company that makes OraVerse, which has just been approved by the FDA for use in speeding the return of sensation after local dental anesthesia, expects to be selling it by the end of the year.

Does the story establish the true novelty of the approach?

Satisfactory

The article does a good job of explaining that the drug itself has been in use for a long time to treat severe hypertension, but that its use to reverse the effects of dental anesthesia is novel.

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

Not Satisfactory

The drugmaker issued a press release on the same day the story appeared in the newspaper.

There is one place where the story and press release track fairly closely, raising questions about the reporter’s independence from this source:

Press release Within one hour after administration of OraVerse, 41% of patients reported normal lower lip sensation as compared to 7% in the control group, and 59% of patients in the OraVerse group reported normal upper lip sensation as compared to 12% in the control group.

Times report About 41 percent of patients who got OraVerse reported normal lower lip sensation one hour after getting the drug, compared with 7 percent of those getting the sham injection. About 59 percent of those who got OraVerse had normal sensation in the upper lip after one hour, compared to 12 percent in the control group.

That, coupled with the fact that only company executives and dentists who consult with the company were quoted leads us to give an unsatisfactory score on this criterion.  

Total Score: 4 of 10 Satisfactory

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