This broadcast segment reports on long-delayed findings about the widely promoted anti-cholesterol drugs Zetia and Vytorin. Overall its implications are accurate: a new report suggests the drugs may not be as effective as previously thought, and the cardiology community is wondering whether those taking it should consider other treatment options.
But the segment has several important flaws.
The most serious flaw is the segment’s assertion that the study found the drugs fail to protect against heart attacks, stroke or death. The anchor suggests this. The reporter says the companies "admit" their drugs fails to protect against those outcomes.
The study did not show that, and the companies did not admit it.
The study found the drugs appeared to reduce LDL cholesterol but contribute to buildup of plaque in the arteries. The study did not, and by design lacks the power to, offer conclusions about the outcomes of heart attack, stroke and death.
The report failed to convey that the study has not been presented, peer reviewed or published. It failed to mention that the study was done on people with a genetic form of very high cholsterol, which is not the condition most people take the drugs for.
The most interesting and publicly significant aspect of the story is that the companies withheld the data for two years and produced it, in a brief form, only after a Congressional inquiry was launched. Instead of reporting this, the segment exaggerated the quality of the findings themselves.
The segment does not mention the costs of either drug. Given the implication that the drugs are heavily advertised because they are money-makers, the report should have mentioned the drugs’ cost compared to the alternatives.
The segment makes no attempt to quantify the results, either the reduction in LDL cholesterol or the increase in plaque volume.
While the story does not go into detail, it makes clear that the drugs may not have the benefits expected–and may expose those taking the drugs to a higher risk of bad cardiac outcomes.
The story failed to mention a related potential harm, that the combination of the two drugs in Vytorin may have higher rates of adverse events than the drug alone in Zetia.
The study upon which the report is based is a prospective, blinded clinical trial of reasonable size and rigor. But it has not been peer-reviewed, published or even presented at a medical conference.
The only report of the results appeared in a difficult-to-parse public statement issued by the drugs’ makers.
The story didn’t make this clear – and it should have.
The segment exaggerates the research question and findings in a way that makes the story more dramatic.
The ENHANCE study’s findings were related to cholesterol levels and plaque accumulation. Yet the reports says, "the makers of Zetia and Vytorin admitted there is no evidence the drugs actually prevent heart attacks, strokes or even death." The anchor makes a similar statement. These statements are misleading. In fact, the bigger issue is that they should be studying real events like heart attack, stroke and death – not intermediate or surrogate endpoints such as plaque levels.
The segment includes interviews with a widely-quoted cardiologist who did not participate in the study and an industry antagonist who is knowledgeable about the drugs. It summarizes the drugmakers’ official response.
The story briefly suggests that older statin drugs may be a better choice for people taking Zetia or Vytorin.
The segment makes clear that the drugs Zetia and Vytorin are widely used.
The segment briefly explains that Zetia works differently than the more common statin drugs.
We can’t be sure if the story relied soley or largely on a news release, although – since the study data hasn’t been published or presented at a scientific conference – it appears it was at least inspired by a news release.