Tests of Cholesterol Drugs Offer Hope of Reducing Heart Attacks and Strokes

Does the story adequately discuss the costs of the intervention?

Satisfactory

It’s difficult to estimate costs for drugs that haven’t yet been approved by the Food and Drug Administration, so we feel this article did an exceptional job discussing the projected costs of PCSK9 inhibitors. The piece quoted executives at CVS Health who said these drugs may cost $7,000 to $12,000 a year, which may strain health care budgets if many people use them. Furthermore, insurers may be hesitant to pay for PCSK9 inhibitors until there is proof that they prevent heart attacks, strokes and death, it said.

Despite the potential high costs, analysts estimated the drugs will have billions of dollars in annual sales, the article added.

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

Satisfactory

The story did a good job of clarifying the risk of cardiovascular events in each study. For evolocumab, the article said, “After one year, 0.95 percent of those in the group that received the drug had suffered a heart attack, stroke or other cardiovascular problem, compared with 2.18 percent in the group that did not take the drug.” The article went into the same nitty gritty for alirocumab: “After one and a half years, the rate of cardiovascular events was 1.7 percent in those who received the drug, versus 3.3 percent in those who received a placebo.”

We applaud that the piece reported the raw percentages, since it puts the benefits into perspective. But high up in the story, it cites the figures in terms of relative risk reduction, making the benefits sound more impressive: “Both drugs reduced the rate of such cardiovascular problems by about half.”

We encourage stories to report benefits in absolute terms so that readers have a clearer idea of what “risk reduction” really means. And since many readers will not read a long story in its entirety, we encourage journalists to put that information somewhere that readers are likely to see it. If an eye-popping relative risk figure is mentioned high up in the story, it should be accompanied by immediate discussion of what that means in absolute terms.

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

Satisfactory

The article mentioned the drugs could cause memory problems and that long-term safety must still be assessed. The story would have been stronger if it had mentioned the actual rates of memory problems found in the studies. Some mention of the side effects seen with monoclonal antibodies used for other purposes would also have been useful.

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

Satisfactory

The story did a fantastic job cautioning readers on the study’s limitations. The two independent doctors provided much-needed perspectives on the studies’ findings – a contrast from the AP story that quoted an independent expert saying the results were “really impressive.” In The New York Times piece, Dr. Steven E. Nissen said the study did not answer the cardiovascular benefit question definitively. And near its end, Dr. Sanjay Kaul goes specifically into the limitations of each study, such as the alirocumab trial using a narrower definition of cardiovascular events and the evolocumab trial being open label. The story could have done a better job explaining what exactly Dr. Kaul meant by that.

High up in the story, there is immediate notification that the studies were small and preliminary. It also made clear the goals of the studies, which were to assess drugs’ safety and whether they lowered bad cholesterol – “not whether they staved off heart attacks. That could make the conclusions about heart attack and stroke risk less trustworthy,” it said.

These are the statements and perspectives we would love to see more of in health and medical news stories. The New York Times story fully deserves a satisfactory rating here.

Does the story commit disease-mongering?

Satisfactory

The story did not engage in disease mongering.

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

Satisfactory

The story quoted two independent doctors – Dr. Steven E. Nissen and Dr. Sanjay Kaul – both of whom pointed out the limitations in the studies. The piece also did an excellent job in disclosing potential conflicts of interest, since pharmaceutical companies often finance the development and research of their drugs. The article stated that lead study authors “Dr. Sabatine and Dr. Robinson have been paid consultants to the companies sponsoring the trials they led.” It also made clear the fact early in the story that these studies were “sponsored by manufacturers.”

Does the story compare the new approach with existing alternatives?

Satisfactory

The article briefly compared PCSK9 inhibitors to statins, or other lipid-lowering drugs like Lipitor, stating that this new class of cholesterol drugs reduced bad cholesterol to lower levels than statins. It also mentioned the drug niacin, which did not protect against heart attacks and strokes, despite it raising good cholesterol levels and moderately lowering bad cholesterol.

However, a more thorough discussion on traditional treatments would have been welcome. For example, why are other lipid-lowering medications needed if there are already quite a few out on the market? The AP story addressed this question, explaining many people cannot tolerate statins or get enough help from them.

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

Satisfactory

The article made it clear that these drugs are in development and not approved by the US Food and Drug Administration, but that such approval could come as early as this summer.

Does the story establish the true novelty of the approach?

Satisfactory

The story states that the new drugs are “already known to sharply reduce so-called bad cholesterol.” It explains that the new studies looked at LDL levels for a longer amount of time and tried to address whether these drugs could protect against heart attacks, strokes and other cardiovascular events.

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

Satisfactory

The article did not seem to be based on this press release or this one. The critical perspectives given by the independent experts in this story are evidence of original reporting.