Posted by Gary Schwitzer in Surrogate markers
There was much news coverage of the announcement yesterday that Merck won’t try to get its cholesterol drug Tredaptive approved in the US after new questions about efficacy and safety were raised in a study.
Tredaptive was designed to raise levels of HDL, or “good” cholesterol.
The findings call into question the benefits of raising good cholesterol, one of the main methods pharmaceutical companies including Eli Lilly & Co. and Whitehouse Station, New Jersey-based Merck are pursuing in their efforts to develop heart drugs. The pill, which generated less than $20 million in 2012, could have hit sales of $1.1 billion in 2020, said Tim Anderson, an analyst at Sanford C. Bernstein in New York. He removed all sales expectations for the drug from his model.
“There are millions of people taking this drug, niacin,” said Steven Nissen, chairman of cardiology at the Cleveland Clinic in Ohio. “Those people are going to be calling their doctors today. This result certainly undermines the likelihood that any benefit from niacin will ultimately be proven.”
CBS News’ story also touched on the important theme when Nissen said in their interview with him:
“It raised the good cholesterol, it lowered the bad cholesterol, it didn’t improve clinical outcomes. That is a stunning finding.”
This study and this announcement are strong reminders for journalists – and for the public they serve – about focusing on outcomes that matter – like whether people lived longer or better – rather than focusing on test scores or blood test values or increases or decreases in certain blood test values.
Findings like lowering bad cholesterol or raising good cholesterol can be called surrogate markers, surrogate endpoints or intermediate endpoints. They are surrogates for things we want to know but may not know yet. They are intermediate messages but they are not the final message of meaningful “truth” about the impact on peoples’ lives that we need to know about an intervention.
Outcomes like whether people live longer, safer, better are what we care about.
If you focus only on the test scores, it’s like the old saying that “You can’t see the forest for the trees.”
Read our little primer, “Surrogate markers may not tell the whole story.”
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