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More incomplete coverage on the benefits of new cholesterol drugs

New drugs show promise for treating high cholesterol

Our Review Summary

This story reports on an analysis of studies involving a new class of cholesterol drugs known as PSCK9 inhibitors. (We’ve previously written about other studies of these drugs and reviewed the related news coverage.) The analysis looked at 24 different smaller studies involving more than 10,000 patients. While it’s clear that levels of “bad” cholesterol were lowered substantially, the question of whether that will save lives from future heart attacks is less clear. The story doesn’t convey that nuance, and emphasizes instead that risk of heart attacks was cut in half with these drugs. But that “halving” of risk means that the heart attack rate went from 1% to around 0.5% — probably not the dramatic reduction that most readers were envisioning. It also misses on several other elements that we think are important for health care stories to convey. Our review offers some suggestions for how the story could have used its 300 words more effectively.

 

Why This Matters

High cholesterol levels are an important risk factor for heart attacks and strokes. Currently statins are the best treatment we have that lowers high cholesterol and the risk of future cardiovascular events. However, statins lower but do not eliminate the risk, and for some the side effects prevent their use. So the search for new classes of medicines that lower the “bad” or LDL cholesterol has been ongoing. The new class of medicines discussed in this story, PCSK9 antibodies, lower LDL cholesterol levels and appear to reduce risk of vascular events. But there is still a lot we need to learn about how well these medications work and whether they are safe for long-term use. It’s worth noting that these medications must be injected under the skin, like insulin, so they are not as simple as statins, which are pills. These medications are also likely to be much more expensive than statins that are mostly available as generic medicines. Whether the additional cost is worth it, and for which patients, is important to ascertain.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not mention costs — and antibody-based drugs are typically on the more expensive end of the drug-price spectrum. Some experts estimate that these drugs may cost in the $10,000-per-year range, which, extended over the lifespan of millions of patients, may be a tremendous burden for the system.

In addition, the difference in costs with statin medications is going to be striking. For those at very high risk in whom statins aren’t enough, adding this medication may be appropriate. The challenge is defining use in those who cannot tolerate statins, since “tolerate” is a relative term. Many patients can be successfully switched from one statin to another. Having the new agent may result in providers and patients trying less hard to find the right medicine. Given the number of individuals who have elevated cholesterol, the cost implications could be staggering.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story implies that the risk of heart attacks to patients is reduced by half with the new drugs. However, that’s a relative risk reduction that likely overstates the size of the benefit — we think absolute risk is more helpful to readers. The key point is that this short-term benefit of a 50% risk reduction is impressive in the studied populations, but the absolute risks were very small. The absolute rates of heart attack in PCSK9 groups were 0.58% compared with 1% for placebo, a difference of less than half a percentage point. Presumably longer studies or studies in higher risk populations may show more impressive absolute reductions. It would also be relevant to compare the results of this new class to statins, the current standard. Generally statins demonstrate ~30% risk reduction. So this may be a more potent class of drugs, but the improvement (if confirmed in additional studies) will be incremental.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

Every class of drugs has side effects, and there has been substantial concern about the possibility of neurocognitive side effects with this class of drugs. The fact that these drugs have to be injected under the skin could also potentially affect use and adherence to a medication regimen. We understand that this story is fewer than 300 words long, but there could have been a statement such as, “More study is needed to assess the potential side effects of this new class of drugs.”

Does the story seem to grasp the quality of the evidence?

Satisfactory

This review study includes data from 24 randomized control trials, so this is meaningful evidence. However, the story seems to trumpet the apparent decrease in mortality without noting how carefully the authors themselves qualify this finding:

“Our study has limitations,” they wrote. They listed four limitations: 1) results are study-level data rather than patient-level data; 2) a few studies have only been reported in abstract form; 3) clinical data was from a very few events; and 4) duration of follow up in some studies as short as two months.

Although the story includes none of that context, it does end on a note of caution: “experts note that although the results are promising, more long-term research is needed to make definitive conclusions about the drug.” For a 300-word story, we’ll call that good enough for a Satisfactory rating here.

Does the story commit disease-mongering?

Satisfactory

There was no disease mongering, although the story’s suggestion that 1 in 6 Americans “lives” with high cholesterol — as if that were a disease in and of itself — gets close to the line.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story quotes Seth Martin of Johns Hopkins School of Medicine, who is one of the authors of an accompanying editorial in the same journal. We salute the quote from someone independent of the study and who appears to have no conflict of interest — but wish he had been identified better. Readers can’t tell who he is from the story itself.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story explains that millions of people take statins in order to lower their levels of a certain cholesterol. It positions these new drugs as alternatives to statins. While that’s enough for a Satisfactory rating, the story does not point out that exercise and changes in diet are also known to lower levels of harmful cholesterol. There are also a number of other therapies available for patients with elevated lipids.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

There is no discussion of when and where these new drugs may be available to the average person, or at what price. A statement that these drugs are not currently FDA approved, and a description of what’s needed to attain that approval, would be appropriate.

Does the story establish the true novelty of the approach?

Satisfactory

The story is clear about what’s new here — an analysis of previous studies of this new class of drugs. .

Does the story appear to rely solely or largely on a news release?

Satisfactory

Since the story quotes an independent expert, we can be sure it didn’t rely entirely on a news release.

Total Score: 6 of 10 Satisfactory

Comments (3)

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Stephen Cox, MD

May 17, 2015 at 7:57 am

You stated statins decrease events 30 %, but did not say if this is relative or absolute risk reduction, as most articles. Which is it?

Reply

    Gary Schwitzer

    May 17, 2015 at 4:57 pm

    Relative.

    Reply

Chris Foley MD

November 12, 2015 at 9:34 am

Apparently no longer taking comments on the original story. However, I would like to add some narrative here. I ran into my first patient who is enrolled in a study involving a PCSK9 inhibitor — alirocumab — that is a so-called “randomized double blind placebo controlled” study over five years. However, very few people realize that this individual has taken on a whole host of integrative strategies as well: Careful monitoring of vitamin D levels, supplemental high-dose omega-3 fatty acids, a strict vegan diet with supplemental lysine to address elevated Lpa levels, supplemental selenium, etc., etc. There is nothing “randomized” about this subject. It is this type of sloppy research that is given the “nothing to see her, move along” treatment by a drug company score simply interested in enrollment. This makes this so-called research utterly laughable. He should be dropped from the study immediately, and I have offered correspondence to one of the principle investigators to that effect. I do not expect to hear back from him.

Reply