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Experimental Drug Raises Good Cholesterol Levels in Early Trial


4 Star


Experimental Drug Raises Good Cholesterol Levels in Early Trial

Our Review Summary

 Beginning with the lead and continuing throughout, the story reminded readers of the limitations of this trial and that questions about health benefits will have to wait for the next round of experimentation. However, although this story gives readers a balanced view of what researchers reported, it should have told them that the trial was sponsored by a drug company and that the lead researcher has financial ties to that company and others in the field.


Why This Matters

When a trial is designed to test safety, stories about the results should focus on that question without wandering off into speculation about health benefits that have yet to be put to the test. That’s what this story does.

Over 20 million Americans currently take statin drugs. Anacetrapib works on cholesterol in a different way, by inhibiting a protein called CETP (cholesterol ester transfer protein). These drugs also offer hope to drug companies that are losing patent protection on the leading brands of statins. That marketing angle means journalists need to be vigilant about claims of benefits. The early tests of an earlier CETP inhibitor, torcetrapib, also indicated powerful effects on cholesterol, especially in raising levels of the “good” HDL form. However, as this story notes, larger trials then discovered dangerous side effects. It turned out that drug actually caused more heart problems than it prevented.

In reality it takes a lot of subjects to even begin to get a picture of the risks and benefits of a new drug. While encouraging, the results of this study are far from conclusive.


Does the story adequately discuss the costs of the intervention?

Not Applicable

Because this story clearly points out that the drug is only part way through the clinical trial process and still has a long way to go before it might be on the market, we can excuse it for not giving cost estimates. Nevertheless, It would have been informative for readers to have made some comment about the potential economic impact of a cholesterol drug, given that over 20 Million Americans are currently taking statin. On the day that the trial results were announced, Merck stock went up even though the market as a whole sagged, demonstrating the financial implications of this research.

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


The story emphasizes the safety questions that were at the heart of this trial. It also tells readers plainly that it is unknown whether the changes in cholesterol levels seen in this trial have beneficial health effects. It does an impressive job in describing the uncertainties associated with drug manipulation of HDL blood levels. After reporting that the HDL cholesterol numbers rose from 41 mg/dl to 101 mg/dl, the story quotes an independent source saying, “Currently, we’re not convinced that manipulation of HDL matters, though certainly it’s promising.” Unlike some other stories about these trial results, this report repeatedly tells readers that any discussion of real health benefits will have to wait at least until after a trial designed specifically to measure such outcome is conducted.

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

Not Satisfactory

The story reports that anacetrapib did not show the type of harmful effects (including higher blood pressure and higher rates of cardiovascular problems and death) seen in trials of a similar drug, torcetrapib, which was pulled from testing. However, the story does not make it clear that this trial was designed to detect harms that were at least 25 percent more common in the treatment group than in the placebo group… so it was not powerful enough to rule out side effects that were less common than that threshold.

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


This story clearly states more than once that this trial was primarily intended to look at safety, not possible health benefits. The lead sentence says the drug  “seems to have passed an initial hurdle by proving safe in preliminary trials.” Only then does it mention that trial participants on the drug saw substantial changes in their cholesterol numbers compared to the people who were given a placebo, with the “good” HDL cholesterol levels rising and the “bad” LDL cholesterol levels falling. Comments such as “simultaneously excited and leery” and “Don’t take this to the bank” emphasized that the results are welcome news, but far from conclusive. The story accurately reports that the researchers saw a tendency toward better outcomes, but that the trial lasted only 18 months, and as mentioned above, the trial was not designed to demonstrate health effects.

Does the story commit disease-mongering?


Although this story doesn’t give details about the type of patient included in this trial and the only specific reference is not quite accurate; it does not engage in disease-mongering. The story says that this trial included patients with coronary heart disease, but according to the article on the trial in the New England Journal of Medicine the participants also included people who were considered to have a greater than 20 percent chance of a cardiovascular event (heart attack, stroke, etc.) within 10 years according to standard risk models. While the story erred in describing the trial participants, the error portrays the story as relevant to a narrower, rather than a broader, definition of eligible patients. So we’ll say that it doesn’t oversell the potential population that might be offered this sort of drug.

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

Not Satisfactory

Although this story includes a strong lineup of independent sources that put the results in context for readers, it fails to report either that the trial was sponsored by the drug company developing anacetrapib or that the researcher quoted in the story has financial ties to that and other drug companies.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Although the story does note that niacin (spelled incorrectly by the way) is the only drug that reliably increases HDL, we would have liked to have seen a bit more information about the role of diet and exercise and how researchers think a CETP inhibitor like anacetrapib (if approved) might fit into the context of other approaches.

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


The story points out that anacetrapib still must be tested in a large clinical trial and is years away from being considered for approval.

Does the story establish the true novelty of the approach?


We’ll give the story a passing score on this criterion because this class of drugs is indeed new and the story did not exaggerate the novelty. However, the story would have been better if it clearly stated that while no drug in this class has been approved for clinical use, there are other drugs at similar stages of testing.

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


The story does not appear to rely on a news release.

Total Score: 6 of 9 Satisfactory


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