Our Review Summary
We liked that this story was cautious about predicting whether or how an experimental new cholesterol-lowering drug called AMG 145 might be useful for preventing heart disease. But there were a few missed opportunities to provide additional context, particularly regarding the cost of the new drug (which will likely be very high) should it ever make it to market and the fact that the outcome measured in this study (LDL cholesterol) is only a marker of heart disease risk that may not reflect a reduction in actual heart attacks.
Why This Matters
As this story points out, there are many factors which can make it difficult for patients to take cholesterol-lowering statin medication. Some patients are troubled by statin-related muscle pain, while others simply aren’t disciplined enough to take their daily dose of medicine as directed. Other patients may never achieve their target for LDL cholesterol reduction despite taking the highest available statin dose. An alternative drug that lowers cholesterol with less frequent dosing and with the potential for less risk of muscle pain might be useful for these patients.
Criteria
Not Satisfactory
The story did not mention costs. This is an important deficiency, since drugs like AMG 145, which are called monoclonal antibodies, are typically among the most expensive drugs in the world and are an important source of rising health care expenditures.
Satisfactory
The says that AMG 145 decreased LDL cholesterol by up to 64%. Although this description isn’t quite as useful as simply telling us what the cholesterol numbers were before and after treatment, the number does convey the point that this was an impressive amount of cholesterol lowering — which is accurate. The story also explains other features of the drug that might be attractive — e.g. the potential for less frequent dosing and fewer muscle-related adverse effects compared with statins. As already noted, the potential limitation of impacting a surrogate marker was worth mentioning. There was room for improvement here, but we’ll call it satisfactory.
Not Satisfactory
The story says that researchers reported no “serious” side effects with the drug. OK, but we wish the story had mentioned that this study was really much too small to even estimate adverse effects. In the past, other monoclonal antibodies have produced rare but serious adverse effects- something that could have provided meaningful context for readers.
Not Satisfactory
The story earns high marks for emphasizing the preliminary nature of the findings and the need for longer studies in people with high cholesterol. Unfortunately, it failed to caution that the study’s main outcome — LDL cholesterol — is a surrogate measure of heart disease risk. Although the benefits of statin drugs are believed to be tied to their cholesterol lowering effects, it is not clear that all drugs which lower LDL cholesterol are effective for preventing heart attacks and strokes. Accordingly, we cannot assume that this drug will be beneficial just because it makes LDL cholesterol numbers move in the right direction. The story should have pointed this out.
Satisfactory
There was no overt disease-mongering in this story. However, several points deserve consideration:
- It would have been useful to have some rough idea of how many patients experience statin-related muscle pain and discontinue the drug because of this problem.
- The story quotes a drug company researcher who says that “a good proportion” of patients are not reaching their LDL cholesterol goals on statin therapy and could benefit from an alternative. Why not add some precision here by citing the results of clinical studies that have examined this issue?
- The focus on cholesterol “goals” is in itself problematic because trials really have not examined goal-based therapy–they have usually compared a moderate dose of statin vs. placebo, or high-dose vs low-dose. The notion that we need to achieve certain cholesterol targets to maximize the benefits of statins is open to discussion and debate.
Not Satisfactory
The story alerted readers to the fact that the study was funded and conducted by Amgen. However, at least one of the researchers who comments on the findings — Daniel Rader — consults for numerous pharmaceutical companies that produce or are developing new cholesterol-based therapies, including drugs that target the PCSK9 pathway discussed in the article. To avoid any appearance of a conflict, the story should have disclosed these relationships.
Satisfactory
The story mentions healthy lifestyle changes and statin drugs as established ways to lower cholesterol. It could have mentioned other approaches — such as nonstatin cholesterol-lowering drugs as well as special margarines fortified with plant sterols — that are sometimes used to lower cholesterol.
Satisfactory
It’s clear that this potential treatment is in an early phase of development and not yet available to the public.
Satisfactory
The story notes that this drug focuses on one of the “hottest targets” for new treatments to lower LDL cholesterol. So readers get the sense that there are other similar drugs in development.
Satisfactory
The story includes comments from experts not involved with the study, so we can be sure it wasn’t based on a news release.
Total Score: 6 of 10 Satisfactory
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