If there's one thing that has been a constant in medicine since forever (or more accurately, since the pervasion of fast food all over the planet), it's that nasty eleven letter word - cholesterol. Basically, from the day you hit 21 years old, the warnings and measurements begin, along with the doom and gloom message that what you eat is what is going to kill you. It's about as popular a message as talking about retirement savings plans to recent college graduates - which quite rightly goes in one ear and out the other most of the time.
However, while saving for retirement at 25 may be a debatable question, if not total anathema, for many, the end result of wolfing down too many cholesterol-laden goodies is all around us and the stats on the number of people dying of cardiovascular disease or heart attacks speaks for itself. Smoking and being sedentary in combination with excessive daily intake of fatty cholesterol is a modern day death sentence; one that is seemingly guaranteed to come knocking at the door, demanding payback.
The pharmaceutical industry took the cholesterol problem to heart and invested huge amounts of money trying to solve the problem, chemically, not least because as humans we are almost pre-programmed to ignore the doctor's advice pretty much most of the time. We want to have our cake and eat it too, quite literally, so the dream is that we can stuff our faces with a daily dose of goodies, but the pill we take lowers our cholesterol in spite of it. Hence the discovery of a drug class that has pervaded society to almost the same extent as fast food, such that the name itself is known to many - we are of course talking about statins.
Statins became tremendously successful blockbuster successes, and in fact Pfizer's Lipitor (Atorvastatin) became the best-selling pharmaceutical in history back in 2003, with the other major brands doing extremely nicely whether in second or fifth place. Statins are a goldmine and deservedly so; it is unquestionable that they have played a major part in eroding heart disease as a death sentence and extending people's lives well beyond what was possible before their discovery.
Having said all of the above, it came as quite a surprise this week to hear on various national news services, both online and in broadcasts, that "cholesterol is no longer a concern". This is to be the take of both the US Departments of Health & Human Services (HHS) and Agriculture (USDA). What? How come? Well, there has been a striking shift in policy seemingly out of the blue, as officials announced that warnings about high cholesterol diets are no longer in the US government's draft dietary guidelines for Americans. The big and burning question is - why?!
Until this week, the government's take on the matter was that people should restrict themselves to a maximum of 300mg of cholesterol a day, thereby reducing the build-up of fatty deposits in the artery walls that is the hallmark of atherosclerosis, which in turn is a major cause of heart attack and stroke. However, there has just been a sharp left turn, with the direction changing into one focused not on how much cholesterol is in your stomach, but rather, how much is in your blood.
According to the USDA, "available evidence shows no appreciable relationship between consumption of dietary cholesterol and serum cholesterol", they said in a new statement. This is an extremely radical take on the issue, clearly emphasising that the key critical measurement is how much bad cholesterol (LDL) is circulating in your blood, almost irrespective of what is in your diet. For sure, it does address the genetic component of elevated cholesterol, in that some people can eat eggs and cheese every day with no effect while others who eat an egg once a week have cholesterol problems.
The draft report, which was put together by 14 renowned key opinion leaders in medicine, nutrition and public health is available online at "health.gov/dietary guidelines"- but it is still strictly a draft until a 45 day response period has passed. The report will be discussed at a meeting (open to the public) in Bethesda, Maryland on March 24th, after which any changes will be incorporated into it and it becomes official HHS and USDA language.
As one cardiologist commented, the committee "clearly is trying to dispel the idea that cholesterol matters", and indeed the committee themselves state clearly that "cholesterol is not a nutrient of concern for overconsumption." This is in total contrast to what has been taught not only in medical school but also contrary to the message we have been getting from our doctors for decades. As much as I understand the nuance that it is how much cholesterol is in our blood that matters, I feel that the message is a potentially dangerous one or one that can be conveniently misinterpreted. There are concerns other than atherosclerosis associated with a high fat-high cholesterol diet and I think that fact should be underlined more heavily.
Although the committee does stress the need to lower saturated fat in our diets (while worrying less about cholesterol), the sound bite that's making the news is that we no longer have to worry about cholesterol. Nevertheless, cholesterol and saturated fat often come hand-in-hand, so telling people not to worry about cholesterol may create the false feeling that they can now eat whatever they want with no worries. To a scientifically less sophisticated public, cholesterol more or less equates with fat anyway, so no worries over cholesterol may equate with no worries about fat - period.
In any case, the pharmaceutical world won't wince too much at this report, because a new focus on serum cholesterol does not impact the future of statins as that is where they exert their effect, unlike agents which prevent cholesterol absorption from the stomach, for example. So statins will survive, and it is the upcoming release of the much-touted PCSK9 inhibitors that threatens to punch a hole in their market dominance, not this report. CVS Health Corp is already at work to limit the cost of this new class of drugs, for their estimate of around 15 million people who may utilise them at an annual cost of $7-12,000 per person per year.
If you do the math, you can see that fighting cholesterol is very big business, and both Amgen and Sanofi-Regeneron stand to reap handsome rewards as the first two out of the gate with FDA-approved PCSK9 inhibitors. Amgen was first to file with the FDA but the purchase of an FDA priority voucher from BioMarin means that Sanofi-Regeneron can catch up after having filed. It is expected that decisions on both drug candidates will be forthcoming this summer, and after that you can expect the cholesterol wars to kick into another gear and rack up huge earnings for those who invested heavily in them.
Who knows, maybe we are approaching a day where concerns over cholesterol will truly be relegated to something in our past, and we get to eat burgers and fries and fish and chips as often as we want. I hope so, but in the meantime, I guess I will be good and take the baked potato instead of fries with my steak tonight - unless those new-fangled cholesterol fries are also about to hit the market?!
PS - there's more good news in the report for us coffee lovers also - it now transpires that up to five cups a day may actually be good for you, after all. So on that note, I am off to grab a large mug of Dante's Infernal Dark Roast that just arrived from far-off fields. Happy Sunday, all!
PS - there's more good news in the report for us coffee lovers also - it now transpires that up to five cups a day may actually be good for you, after all. So on that note, I am off to grab a large mug of Dante's Infernal Dark Roast that just arrived from far-off fields. Happy Sunday, all!
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