The biggest strike against this report of a test of a new type of drug to lower LDL “bad” cholesterol is that it fails to make clear that simply lowering LDL does not always prevent adverse health outcomes (heart attacks, strokes). While the story does point out that this test included only people with a rare genetic mutation, many readers might still miss the point that the results may not mean anything to the average heart disease patient. The relevance of the story is also limited by the predicted high cost of a drug like this (at least $10,000/year according to some analysts), an important bit of context the story leaves out. Readers also aren’t told that Amgen funded the trial and the researchers were employees or receive money from Amgen for consulting and other services.
People who have had a heart attack or other cardiovascular disease may reduce their future risks by taking a statin drug. However, some treatments that lower LDL cholesterol have failed to demonstrate real health benefits. News reports about experimental cholesterol treatments should always point out the distinction between lab test results and meaningful health outcomes.
Although this drug is still experimental, the story should have told readers that some analysts predict that this sort of drug, known as a biologic, will cost at least $10,000 a year, compared to less $200 a year for a generic statin. Many observers predict that the extremely high cost of this new type of cholesterol-lowering treatment is likely to mean it would be used only when statins don’t do the job, which means this line of research may never be relevant to most people.
The worst failure of this story is that it compares the new drug to statins without telling readers that, unlike statins, no study has yet shown that this new drug or others like it actually reduce the risk of heart attacks or other health problems.
The failure is not the reporter’s alone; the researchers also make similar comparisons – failing to heed the warnings of experts who point out that there is no solid evidence that lowering LDL cholesterol always produces health benefits. Indeed, while statins that lower LDL cholesterol have been shown to produce real health benefits in certain patients, trials of other types of drugs (e.g., clofibrate) showed that despite lowering LDL, the risk of heart problems was not reduced.
The story meets the minimum requirement of this criterion by reporting some of the side effects seen in this drug trial. However, it should have noted that the trial was too small to see less common side effects. Indeed, a trial this small would be unlikely to detect the muscle pain and weakness that cause serious problems for some similar patients when they take statin drugs to reduce cholesterol and heart-related risks.
This story calls the trial “midstage” and notes it is a phase II trial; but it fails to point out that this sort of trial is not designed to demonstrate real effectiveness.
Although this story meets a minimum standard by reporting that the trial looked only at people with a genetic mutation that causes high cholesterol and heart disease, and that this mutation affects about one person in 500, it should have been more clear that the results of this trial may have no relevance to the 99.8% of people who do not carry this mutation.
Not only are independent voices absent from this story, there is no mention that the study was funded by Amgen and the researchers were either company employees or receive consulting fees or other compensation from Amgen.
While the story mentions statin treatment for high cholesterol, it fails to tell readers that this trial does not provide evidence that would allow people to compare meaningful harms and benefits of this experimental drug to those of statins.
The story points out that the drug is still experimental.
The story briefly mentions that other similar drugs are being tested. It would have been better if the story had pointed out this trial is not the first to test this drug in patients with inherited high cholesterol. For example:http://www.nejm.org/doi/full/10.1056/NEJMoa1105803
There is little to go on to determine what source was relied on.