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Med center PR release: Patient with high cholesterol doing great because of drug we helped develop

PCSK9-Inhibitor Drug Class That Grew Out of UT Southwestern Research Becomes a Game-Changer for Patient with Extremely High Cholesterol

Our Review Summary

Frank Brown, the subject of this news release, with Dr. Khera, his cardiologist.

This news release describes one patient’s response to a “game-changing” new drug designed to help patients manage their cholesterol, and offers a brief history of how this class of drug was developed and how they work. The release offers only anecdotal data on the drug’s efficacy — it offers numbers for only one patient. What’s more, the release doesn’t even tell readers which drug the patient took (though it narrows it down to one of two drugs). It also tells readers nothing about costs or potential harms, and describes high cholesterol as a disease — instead of as a risk factor for disease.

 

Why This Matters

High levels of cholesterol, especially high levels of low-density lipoprotein (LDL) cholesterol relative to high-density lipoprotein cholesterol, are widely considered a significant risk factor for heart disease. However, it is only a risk factor — it is not a disease in itself. It is important for news releases to characterize this distinction clearly, particularly when the focus of the release is a drug treatment that costs thousands of dollars and carries health risks of its own. That said, the larger question here is why a health research institution issued a news release that offers only anecdotal data on the health of a single patient taking an unspecified drug.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The release does not address cost at all. While the release does not tell us which of the two new drugs the patient took, it does tell us that he took either evolocumab (sold under the trade name Repatha) or alirocumab (sold under the trade name Praluent). Both drugs are given via injection either once or twice a month. According to press materials issued when Repatha was approved by the FDA in August 2015, “The U.S. Wholesale Acquisition Cost (WAC) price of Repatha is $542.31 for one 140 mg single-use prefilled SureClick autoinjector or prefilled syringe, or $14,100 annually for the every two weeks administration.” That’s not chump change. According to press materials issued when the FDA approved Praluent last July, “The U.S. WAC price of Praluent is $40 per day ($1,120 every 28 days) for both the 75 mg and 150 mg doses.” Again, that’s not an insignificant expense. The cost to consumers may vary, depending on each patient’s insurance, etc., but failure to address cost is a significant oversight.

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

Not Satisfactory

This falls short in two different ways. First, the release only tells readers how much one patient’s LDL cholesterol dropped (from 384 to 111). That’s anecdotal data. And, because the release doesn’t tell readers which drug the patient was taking, it is not even clear which drug was responsible for that single patient’s lower cholesterol numbers. Second, the release doesn’t tell readers what this reduction in LDL cholesterol means in terms of the patient’s actual health. Does it reduce the patient’s risk of a heart attack? If so, by how much — a lot? A little?

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release does not mention potential harms at all. If anything, it does just the opposite, saying at one point that an observation of a woman with a genetic variation that naturally confers the effects of this class of drugs suggests that “therapies aimed at blocking [the protein targeted by these drugs] would not only be effective, but also safe.” That’s a good anecdote about the inspiration for the drug treatment, but it’s problematic in a release that seems to focus almost exclusively on anecdotes. Particularly since the release does not tell readers that both evolocumab and alirocumab have potential adverse side effects. According to the press materials for evolocumab (Repatha), “In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2% of Repatha-treated patients.” And the press materials for alirocumab (Praluent) note “Praluent can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital.” What’s more, there could be less common, but more serious adverse effects that will only come to light after large numbers of patients take these drugs for long time. There is nothing in the release that says for how long the drug was used. These potential health effects are worth noting — especially in a release that focuses solely on the use of a new class of drugs.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release shares incomplete information on one patient’s experience. That is not satisfactory.

Does the news release commit disease-mongering?

Not Satisfactory

This is a close call but we think it crosses the line to Not Satisfactory. We stated this above, but it bears repeating: High levels of cholesterol, especially high levels of LDL cholesterol relative to high-density lipoprotein cholesterol, are widely considered a significant risk factor for heart disease. However, it is only a risk factor — it is not a disease in itself. The release refers to “dangerously high levels of cholesterol” in its opening paragraph, and it focuses on the story of a patient with familial hypercholesterolemia — a condition that is known to cause premature heart disease. But it never tells readers that cholesterol is only a risk factor and doesn’t give any insight into how common this condition is or how worried the average reader should be about it. “There are many more Frank Browns out there – patients who can’t control their cholesterol with the standard drugs,” the release says. How many?

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release doesn’t talk about funding for this individual patient, which is fine. But it does talk about a number of researchers who were involved in developing evolocumab and alirocumab. Were those researchers supported by the relevant drug companies? Does the medical school itself have partnerships with these companies? It’s not clear. If those potential conflicts do not exist, it would have been good to make that clear — particularly in a case like this, where the rationale for the news release is not clear to readers.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release does mention three other drugs that are designed to reduce cholesterol levels. However, the release would have been stronger if it had also mentioned the importance of diet, exercise and other lifestyle factors that can significantly influence cholesterol levels.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The release notes that the drugs have been approved by the FDA, and that at least one of them was available to the patient described in the release. The reader can infer that the drugs are available to the public.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The release explains what is novel about this particular class of drugs. However, it’s not at all clear why this release is coming out now. The drugs themselves were approved by the FDA last summer and the release does not appear to be related to the publication of research findings. There is virtually no information here that was not available six months ago, other than the anecdotal data on one patient.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

We would like to give the release a pass here, because we already dinged the release for the way it discusses cholesterol under “Disease Mongering.” However, we can’t. Here’s why: the release refers to this drug class as a “game-changer” in its headline. What does that mean? Even accepting the fact that the headline says the drug was a “game-changer” for only one patient, it’s still pretty fuzzy. Did the drug lower the patient’s LDL cholesterol to optimal levels? No, and the release itself says as much. Did the drug significantly reduce the patient’s risk for future heart problems? It’s not clear, because the release doesn’t address that. If a release is going to use hyperbolic language — whether it’s a “game-changer” or a “breakthrough” or a “holy grail” — it needs to clearly lay out the results to back it up. That is not the case here.

Total Score: 2 of 10 Satisfactory

Comments (2)

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Eskimo

March 3, 2016 at 2:43 pm

It looks like an article for a UTSW promotional magazine, which got posted on Newswise, even though it’s not really a press release (no specific anchor time etc)

Reply

    Gary Schwitzer

    March 5, 2016 at 6:01 am

    It’s labeled as a news release as it appears on Newswise.

    Reply