This is the week of the huge American Heart Association annual scientific sessions – this year in Los Angeles. That’s why you’re suddenly seeing so many cardiovascular-related news stories. Stories like one in the New York Times, “New Drugs For Lipids Set Off Race.” This story begins:
A new class of powerful cholesterol-reducing drugs is showing promising results, potentially offering a new option for people who do not respond to medication now on the market, according to studies presented at a conference of heart specialists here on Monday.
Although the final word on the effectiveness of the drugs is still a few years away, the results so far are so promising that pharmaceutical companies are racing to bring them to market.
Not a bad start. A bit fawning with the “results so far are so promising” line, but let’s move on.
In early- and middle-stage trials, use of the experimental drugs reduced so-called bad cholesterol by about 40 to 70 percent in a matter of weeks, equivalent to the reduction achieved by the most effective statins like Lipitor. But it appears that the new drugs can be used along with statins, lowering cholesterol even further.
With these drugs, together with statins, you can get virtually everyone to the goal, Dr. Frederick Raal of the University of the Witwatersrand, in Johannesburg, South Africa, who presented one of several studies on these new drugs at the American Heart Associations scientific meeting here.
OK, we need to stop right there. A 40-70% effect size sounds pretty impressive. But didn’t we just read some warnings about intepreting big effect size claims? (If you forgot, we’ll remind you later in the piece.) Then there was this quote: With these drugs, together with statins, you can get virtually everyone to the goal” ?? How could this statement possibly be supported by the available literature? Then the story continues:
The most advanced of the drugs, which as a class are called PCSK9 inhibitors, is only now entering the final stages of clinical trials and is not likely to get to market until 2015 at the earliest.
And there are still some caveats. One is that while the drugs lower cholesterol, it has not yet been shown that they actually reduce the risk of heart attacks, strokes or other cardiovascular problems.
Furthermore, many of the studies so far have lasted no more than 12 weeks and involved fewer than 200 people. Far longer and larger studies are needed to show that the drugs would keep working over a lifetime and would be safe.
That’s better. But the story let the researcher get away with a totally unsubstantiated claim before it delivered these caveats. Why allow such a game of editorial ping-pong? No one benefits. No one likes it.
More broadly, business stories like this – and it is clearly labeled as a business story – even online, which is often not the case with business-of-health stories on the websites of many news organizations – drive me up a wall.
I asked Harold DeMonaco, one of our expert story reviewers to comment on the story. He responded:
“These new drugs represent an interesting approach that has not been explored previously and they have a rather interesting mechanism of action. There is reason to believe that alone or in combination with a statin, they may allow patients with resistant elevated LDL levels to approach ideal serum levels. Whether the lowering of LDL by this mechanism will in fact lower cardiovascular risk is an open question. The jury has just begun deliberations. We are not told anything about the side effect profile or the sample size of the studies discussed (the NEJM paper had 30 subjects in each group similar to that in the Amgen trial in JAMA). These drugs are monoclonal antibodies, so their cost is likely to be significant to say the least.
These drug are exciting to the cognoscenti because they work by a new mechanism. Whether they deserve this much attention by the general public is open to debate.”
Yes, interested readers should have access to information about drugs in development if they want that information. But let me suggest that they be reminded of the warnings embedded in the 10-year old JAMA paper, “Media Coverage of Scientific Meetings: Too Much, Too Soon?” That paper’s final line:
“Results are frequently presented to the public as scientifically sound evidence rather than as preliminary findings with still uncertain validity. With some effort on the part of meeting organizers, journalists, and scientists, it will be possible to better serve the public.”
Now what about the big effect sizes that were reported? If you forgot or were unaware, JAMA just last week published a paper, “Empirical Evaluation of Very Large Treatment Effects of Medical Interventions,” which concluded:
“Most large treatment effects emerge from small studies, and when additional trials are performed, the effect sizes become typically much smaller….
Trials with very large effects are more likely than other trials to pertain to laboratory-defined efficacy…However, the relevance of laboratory end points as surrogates of hard clinical outcomes has long been contested.”
The author of an editorial about that paper, Dr. Andy Oxman, was quoted in one news story:
“I suspect that many patients tend to think that an intervention either works, or does not work, without fully considering the size of the effect and potential adverse effects.”
That paper and editorial were just published last week. Maybe they haven’t sunk in yet. But they addressed exactly the kind of issues that bugged me about the New York Times story – and so many other stories – coming out of the big heart conference. Whom do they serve? Patients/consumers? I don’t think so. Investors? I don’t think so. The vested interests behind these claims? Bingo. Is that the job of journalism?
By comparison, a Wall Street Journal story, “Is There Life After Lipitor,” delivered far more caveats and context, while still allowing the enthusiasm of the marketplace to ooze out. Examples of greater emphasis in the WSJ story:
Addendum on November 8 with related news:
Addendum on November 9:
Addendum on November 11:
“I’m beginning to think that Schwitzer’s criteria for judging stories ought to be printed on wallet cards for reporters, like Miranda warnings, to remind them what questions to ask. I could use one of those myself.”
We’ll work on it, Paul. Thanks for the kind words.