This was an overly enthusiastic account of a study on an experimental new drug called anacetrapib that lowers bad cholesterol and raises good cholesterol. The study was designed to look primarily at the safety of the drug and not whether it prevented heart attacks. But that didn’t prevent the story from making some wildly positive statements about the likely benefits of treatment. The story stumbles out of the gate with an over-the-top prediction about how the drug “may conquer heart disease.” It continues to lay on the hype with quotes about the “incredible” results and how the drug could be “the perfect new treatment for all people at risk of a heart attack.” We realize some of this enthusiasm came from the mouths of experts but we know there are many who would be far more cautious and we didn’t hear from them in the story. It closes with an erroneous description of how many people died in the study.
Needless to say, not what we hope to see on the front page of the nation’s highest-circulating daily.
By comparison, look at how NPR closed their online story: “Still there were four deaths from cardiovascular causes among the 800 patients taking Merck’s drug compared with just one among the same number in the the just-released trial results. So don’t count Merck’s drug approved just yet.”
(Please note: we reviewed the first version of each story that we found – not any subsequent versions the news orgs may have published. In fact, the version we reviewed doesn’t even appear online anymore.)
It would nice if preventing heart attacks was just a matter of lowering bad cholesterol and raising good cholesterol. However, research increasingly suggests that it isn’t as simple as that. Drugs that lower bad cholesterol through one mechanism do appear to be effective, but drugs that lower it another way may not offer the same protection. Similarly, people with naturally high good cholesterol seem to have a low risk of heart attacks, but not every drug that raises good cholesterol has cardiovacular benefits. (In fact, another experimental drug that raises good cholesterol was shown recently to increase the risk of heart attacks.)
So far, the drug discussed in this story doesn’t appear to have the same problems as its good cholesterol-raising predecessor, but at this early stage of development we simply don’t know if it works. Larger studies might show that the drug has safety problems that haven’t shown up in this study. Or it might turn out that the drug is safe but doesn’t offer much protection. Some drugs even get approved only to later be recalled because of rare but serious adverse effects that aren’t apparent until millions of people start taking the medicine.
This is all a way of saying that caution is required when a drug is this early in its development. There are any number of ways that it could get derailed prior to reaching the market, and so journalists have to take care not get too caught up in the excitement.
Even if this new drug does ultimately prove effective for preventing heart attacks, we need to know what this benefit is going to cost us. Although it may be too early to provide an exact figure, the story could at least have mentioned what treatment with other cholesterol-targeting therapies costs.
An error in this story may lead readers to believe the drug is more effective for saving lives than is actually the case. The story states that there were “16 deaths in the anacetrapib group, versus 21 in patients taking a placebo.” In fact, there were 11 deaths recorded in the anacetrapib group and 8 in the placebo group during the time patients were taking the medication. The statistic referred to in the story is for a combined outcome that included cardiovascular deaths, heart attacks, hospitalization for unstable angina, or stroke.
The study also used relative risk descriptions to describe the benefits attributable to statin drugs, saying they lower risk by 25-30%. We think this characterization will lead readers to overestimate the effectiveness of these drugs. The absolute reduction in heart attack risk is about 1% for statin-treated patients, and 100 patients need to be treated for 3 years to achieve a benefit.
Finally, the story focuses excessively on the “unprecedented” changes in cholesterol achieved with the drug. As discussed earlier in the review (see “Why This Matters”), these are surrogate markers that may not reflect any real benefit on the outcomes that matter to patients. And the story didn’t provide data on what participants’ cholesterol levels were before and after treatment, or what levels are considered healthy. We are only told about the percentage change, which is not very useful without this additional context.
Although the potential for harms was mentioned, this story didn’t provide quite enough detail to satisfy this criterion. Citing a company representative, the story states that the new drug didn’t cause the lethal side effects associated with another experimental drug that works through similar mechanisms. While this is true and important to point out, the story should also have mentioned the potential for other effects that could potentially harm patients and would limit the use of the drug. Notably, the researchers had to discontinue treatment in 17.6% of patients receiving the drug because their bad cholesterol levels dropped to a level that might be harmful. In addition, more patients died in the drug treatment group compared with the placebo group, although the story erroneously states that the opposite was the case. (See the Benefits criterion for more discussion of this).
This article starts things off with a grandiose and unsubstantiated claim — that “doctors” are predicting the new drug “may conquer heart disease.” Really? Which doctors said this? And why weren’t they quoted in the story? We couldn’t find anyone in the story who said anything close to this.
Based on this story’s extremely liberal paraphrasing and selection of gushing quotes, readers might come away thinking that this drug is going to help everyone avoid heart disease. But the study involved a carefully selected group of patients who were already at high risk of a heart attack because they had already had a heart attack or had various other risk factors. It’s not at all clear that this drug is going to be beneficial for patients who are at lower risk of disease, even though many of these apparently low-risk patients still get heart attacks.
This study’s purpose was to test whether the new drug was safe and had the desired effect on cholesterol. It could not tell us whether the drug helps prevent heart attacks or deaths. So while we appreciate that the story had some caveats to this effect — e.g. the drug “is still experimental and must be tested in a larger trial” and “the study wasn’t designed to test its power to prevent heart attacks” — we think there was an imbalance of cheerleading quotes and positive speculation without a more vigorous attempt to discuss the limitations of this preliminary research.
Although the story raises some red flags with its emphasis on surrogate markers and overgeneralizing who might would be a candidate for treatment, these are deficiencies that we address in other sections of the review. Otherwise, there was no evidence of overt disease-mongering.
The story solicits comments from multiple expert sources. We wish, however, that perspectives had been obtained from experts without ties to the drug industry. This might have turned up someone willing to put a restraining hand on this story’s excessive enthusiasm.
In addition, we think the story should have mentioned the study’s source of funding (Merck, the drug’s manufacturer) and the fact that several investigators have financial relationships with the company.
The story did not mention other classes of drugs that raise HDL, such as niacin and fibrates.
The story states clearly that the drug is experimental and is not yet available to the public.
The story makes reference to the relevant research that preceded development of the drug and mentions an “older relative” (the experimental HDL-raising drug torcetrapib) that was not approved because of an increased risk of lethal adverse effects. Although we’ll award a satisfactory, we think the story could have gone into more detail as to what happened with this “older relative” and why it failed. Some data suggest that the drug failed because it raised blood pressure — something which the new drug apparently does not do. But some researchers believe the drug may have failed because raising HDL with a drug doesn’t confer the same benefits as having naturally high HDL. Discussion of this background would have been useful.
This story does not appear to be based on a news release.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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