A front-page story in the New York Times today, “Rare Mutation Ignites Race for Cholesterol Drug,” is worthy of further exploration. Any time the NYT puts a health/medical/science story on the front page, it probably warrants further exploration.
But I don’t think NYT front-page placement automatically warrants further front-page pickup by media across the country, but it often does get that imitated response. My local Star Tribune paper put today’s cholesterol story even higher on its front page than the Times did.
When smart, veteran science journalists – like Gina Kolata in this case – get front page space, it’s often because they capture a compelling combination of intriguing science and “Wow, what if?” framing. This story frames:
These were just a few of the things that caught our eye at first glance. Intriguing story. Terribly incomplete.
Journalist Paul John Scott wrote me about the story early today. When reading it, he reflected:
“Yes, let’s start drugging LDL down to 25; what could possibly go wrong? The piece made me sad, mostly. I can’t see how a reasonable person doesn’t read this and envision the day the patent runs out and the economy has been drained of another trillion in game changer drug spending and heart disease remains firmly in place.” He thought the story should have looked at “the side effects of lowering LDL, and the heterogeneity of LDL, and the questionable returns of statins, and the dubious nature of moving surrogates for risk factors.”
Harold DeMonaco, MS, one of our most active story reviewers and guest bloggers, offered his own reaction:
There are numerous quotes from folks from industry and their clinical consultants in the story but the following caught my attention: This is our top priority, said Dr. Andrew Plump, the head of translational medicine at Sanofi. Nothing else we are doing has the same public health impact. An interesting perspective to say the least. While I appreciate the desire on the part of pharma to identify a blockbuster drugs, something it has failed to succeed in for some time, suggesting a dramatic public health impact may be a bit extreme.
Heart disease is a major problem in the United States and a leading cause of both death and disability. The introduction of the statins in the late 80s revolutionized the approach to primary prevention. As the story notes, Statins, the cholesterol-lowering drugs that went on the market in 1987, were a huge breakthrough, but far from a panacea. But why are they less effective than the clinical trials showed? Is it because we need new approaches to lowering LDL cholesterol? How low is low enough and in whom? My read of the story is that we do indeed need new drugs for people with difficult to treat elevated levels of LDL cholesterol and if a little reduction is good, greater reductions must be better. And yes it will cost more but isnt it worth it?
Do we in fact need new drugs? Perhaps but we should probably do a slightly better job with the ones we have. At the moment there are about 24 million adults in the US taking a statin drug. Many do not take the drug regularly. At least one simulation study (J Epidemiol Community Health. 2010;64(2):109-113) suggests that increasing compliance and adherence from the existing rate of 50% to 75% would dramatically reduce cardiovascular deaths. Improving communication between patients and their healthcare providers might be a reasonable step in improving adherence and compliance to therapy. Although it would seem to be in the industrys interest to improve compliance (and sell more drugs), at least three major players seem more interested in identifying the next blockbuster. But the problem simply does not lie with the patient. Failure on the part of the prescriber to escalate what appear to be inadequate statin dosing has also been shown in numerous studies. Again, it would seem to make more sense to improve how we use our existing treatments than developing new and far more expensive treatments.
All current guidelines for cholesterol management include stipulations for relative risk but none to my knowledge suggest lowering LDL cholesterol to the levels that are described in the story. Are there data to support lowering of LDL cholesterol (regardless of risk of cardiovascular disease) to, well below 50 as was described by one of the clinician consultants for Sanofi? Shouldnt we know the answer to that first?
And finally, lets think about costs. How much do you suppose a monthly injection of a monoclonal antibody will cost the consumer? If the current crop of injectable monoclonals used to treat rheumatoid arthritis are an indication, we are talking about $2-3,000 monthly. The cost of a generic statin is less than 10% of that. The investment of $70 million for a plant seems like a good one since it would only take about 3000 patients to recoup the cost of the plant.
As the story suggests, the race is on. But do we really need to play?
My reactions, and those of Scott and DeMonaco are quick, first-read reactions. We didn’t know the NYT story was in the pipeline. Kolata and the Times had a lot of time to prepare their story and far more horsepower to put their story together than we three individuals did in giving quick reactions to something about which we had no advance notice. But our reactions, our off-the-back-of-the-envelope questions about framing, about evidence, about balance should be helpful to other journalists and to consumers (news consumers and health care consumers) as they read or hear news stories about “fevered races…public health impact…exciting results…blockbuster…might be used by one in four adults.”
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