Over the past two weeks the ABC’s Catalyst program has run a special series under the rubric The Heart of the Matter calling into question the importance of cholesterol as a risk factor for heart disease with Dr. Maryanne Demasi leading the charge. This is how she described the programs:
In the first episode of this two part edition of Catalyst, I investigate the science behind the long established view that saturated fat causes heart disease by raising cholesterol.
In the second episode, I cut through the hype surrounding cholesterol lowering drugs and reveal the tactics used by Big Pharma to make the drugs to lower cholesterol appear more effective than they seem to be.
In Heart of the Matter, I investigate whether the role of saturated fat and cholesterol in heart disease is one of the biggest myths in medical history.
Go here for transcripts and videos:
First up it must be said that Dr Demasi is not just a journalist. She has a PhD in medical research from the University of Adelaide and worked for a decade as a research scientist specialising in rheumatoid arthritis research at the Royal Adelaide Hospital.
I had a triple bypass back in 2000 and have taken statins ever since as well as 100mg aspirin daily and medicine to lower my blood pressure. Except on rare occasions saturated fats do not pass my lips.
Dr Norman Swan told Fran Kelly that his wife had sat next to someone on a plane who had been taking statins for familial high cholesterol levels. After seeing the program he said he had dropped the drugs and was going to tuck into the cream cheese.
To this viewer, such a response would be warranted on the basis of the evidence put forward in the programs. I’m a cautious person, however, so my intention was to stay on course, but was going to consult my GP who I see every four to six weeks. I expected her to advise me to change nothing until I next see my cardiologist in March next year.
Norman Swan was angry. He said people will die as a result of the program.
Then on RN’s Health Report Swan interviewed Professor Peter Clifton, NHMRC Principal Research Fellow and Professor of Pharmacy and Medical Sciences, Sansom Institute, University of South Australia. Clifton gave all the information you’d ever want to hear, I thought. It included this statement:
lowering LDL is the most powerful thing you can do to reduce your heart attack risk, but it doesn’t remove it completely, it only removes it by a third unfortunately.
Asked directly what he thought of the program Clifton said he was appalled because it was completely unbalanced.
Clifton’s advice was to stay on statins if you are on them, but if you are worried go to your doctor, calculate your risk factor, taking all components into account – diet, exercise, gender, smoking, life stresses and whatever – and then make a decision. Certainly some people experience deleterious side-effects, but Clifton thought these were over-emphasised.
So now I’m not going to raise the issue when I see my GP. I’m betting she’ll raise it with me. Statins have never been represented to me as a magic bullet, just one measure among many to give yourself a better chance.
Along the way Professor Emily Banks, chair of the Advisory Committee on the Safety of Medicines, wanted the second program canned after seeing the first.
Dr Lyn Roberts, CEO of the National Heart Foundation, said the organisation was ‘shocked’ at the ABC decision to run the Catalyst program on statins.
RN’s PM program caught up with Dr Demasi, who was holding her ground. She clearly supports the notion that people should consult their own doctor, but the program did downplay the role of cholesterol as a driver of heart disease to the point of irrelevance. It did also suggest that statins will do actual harm beyond mere side-effects. And one expert consulted suggested that as few as one or two out of every hundred might obtain some benefits.
Is it not the case that the four “experts” she interviewed were not experts at all and several of them had interests in alternative heart disease treatments, all undeclared? I read this somewhere on the internet.
I don’t think there’s any doubt in the medical communty of the importance of controlling blood pressure and cholesterol. This Catalyst episode is incredibly dangerous. What next, an anti-vax episode?
FN – I didn’t see the programs, but I’ve heard somewhere or other that statins cost the tax-payer more than a billion $$ per year. So whether or not they are effective is worth debating.
I always thought they were mostly effective in people that had actually had some sort of heart attack or disease. Yet an awful lot of Australians must be taking the things.
The program might be good if it causes people to ask their doctor if they could manage their cholesterol level some other way – diet & exercise, for example. Maybe there is some over-prescribing of statins, as a sort of just-in-case, or easy-way-out approach to high LDL levels?
Russell, that’s a question of cost-effectiveness, not effectiveness.
The problem with “diet and exercise” as a control mechanism is that people don’t do it. Look around you at the Aussie population. If people had any interest in diet and exercise to control risk factors, the population wouldn’t be so enormously fat. As a prescription for people who like exercise it might work, but for the rest of the population it’s a recipe for disaster.
As a person with ME/CFS, and knowing lots of people with ME/CFS, I can attest to the displeasure and distrust that our community holds towards Dr Swan, because of the attitude he has expressed on his Tonic programme regarding our illness, specifically that it is an illness of belief, or “mostly in the mind.” ME/CFS is not a mental or psychological disorder. It is an auto-immune disease.
FN – but it would be a question of effectiveness if giving statins to people who simply had higher than ideal LDL levels didn’t actually prolong life?
Yes, people aren’t so good at the diet & exercise habit, but programs like this might at least prompt people to think more about side-effects of what seems an easy option.
The NICE guidance (pdf) says they’re both effective and cost-effective:
The effects are bigger and more widespread on people with evidence of coronary heart disease at implementation. Results that NICE based its recommendation on were from 28 randomized controlled trials.
The NICE guidance also assumes that doctors will be assisting patients at risk of heart attack with dietary and exercise changes. Without those interventions, the effects of statins would likely be even bigger.
I don’t think the difference between primary and secondary prevention was clearly explained. Statins have a role in secondary prevention (as Russell notes above) e.g. if you already have had a heart attack, but the evidence in primary prevention (people who may have risk factors for heart attacks etc) is not as clear cut.
I didn’t see the first one but the second one definitely gave trying to sell it’s message greater emphasis than examining the evidence rationally.
That said, the benefits of statins in secondary prevention are modest – typically 25 people have to take them for 5 years to prevent 1 death. Great if you are the 1 but no so impressive if you are in the group of 24 who gain no benefit.
Thanks, FN – I hadn’t heard of NICE (or worse, had forgotten)
That’s an epidemiologically misleading statement, rf. If 25 people take them for 5 years to prevent one death, how many deaths occurred in the group? 2? If so, the risk of mortality for everyone in the group has been cut by a third. Unless we have a magic technique for knowing which of those 25 would never have benefited from the statins in the first place.
Cutting risk of mortality by a third in a disease that kills 3 people in every 25 (i.e. 1/8) over just five years is a huge benefit to society. Compare with cervical screening, for example, where the same benefit might accrue from screening 1000 women for five years.
I think your numbers are suspect (what is your source?) but they certainly don’t tell the story you claim.
FN, the numbers are based on the NNT (Number Needed to Treat) calculated from the 4S study, one of the early statin trials that proved a benefit with statins in patients who either had ischaemic heart disease or had a prior heart attack. The absolute reduction in mortality was 4% from which you can calculate the NNT (it is the inverse of the absolute risk reduction).
From the NNT.com
“Unless we have a magic technique for knowing which of those 25 would never have benefited from the statins in the first place.”
That is one one the problems that exist in medicine; we don’t know who will benefit alas.
So, to conclude, I don’t think you can call it epidemiologically misleading; it is commonly used to cut through all the “risk reduction odds ratios” and “relative risk reduction” flim flam that so many trials report.
The NNT.com is well worth a visit btw.
It’s epidemiologically misleading because you are saying that the people who didn’t have a death averted therefore didn’t benefit. But not everyone was going to die in that 5 years. You can’t say that if x people didn’t die, therefore (Y-x) people didn’t benefit – unless you can say which of the Y-x people would never have benefited from the treatment. If you can identify some proportion of the Y-x who wouldn’t have benefited, you shouldn’t have put them on the drug in the first place.
Which means, that if you treated 25 people over 5 years, and you avert 1 death, and 2 deaths occurred, then 23 people benefited from the drug (since you don’t know which of the 23 people would have been the prevented death).
Also, just to repeat – a NNT of 25 is really good. Breast screening is between 300 and 200 women needing to be screened annually.
Just looking at the latest Medical Observer and it has:
this
I was thinking of a couple of married friends I have who seem like the guy in the article, except they wanted the statins and have been taking them for the last 10 years. They have an awful diet and don’t exercise.
I think that would be dependent on the cohort. I can think of circumstances where the lack of those interventions would decrease the effectiveness of statin treatment, and indeed where such a decrease may be exacerbated by individual cases of negative side-effects.
FN, I think this is a bit of a semantic argument but I take your point. I just see it differently is all.
Yes, an NNT of 25 is pretty good in the world of medicine; I just don’t know whether patients realise the absolute risk reduction is pretty small cf the relative risk reduction (which Drug Companies tend to spruik).
Yes Russell, the point that link makes quite clearly is that there is plenty of evidence for making judgments about the use of statins as primary prevention. There is a tool to help doctors make the judgment. Prescribing any intervention to reduce a 3% risk of something happening over 5 years is obviuosly going to produce a limited benefit, which is why the tools exist (note the 20% risk threshold often used).
I haven’t seen the Catalyst show but from all the criticism I don’t get the impression that it mentions these things or discusses them in any detail. It seems to be implying that everyone over 50 is on statins no matter what, or that doctors aren’t paying any attention to diagnostic criteria. Your medical observer article doesn’t really support that kind of perspective, does it?
I haven’t watched the second program yet, but the first was appalling and, in my judgement, heads should roll at Catalyst for permitting it to be put to air.
It doesn’t matter if Dr Demasi is a scientist or not. She is acting as a science journalist in this matter, albeit one who is better qualified than most. But, regardless, if the overwhelming scientific consensus is that X is true, and the only people who will go on camera to support your view that X is false are a few cranks with axes to grind, there’s no story.
It may well be that on an investigation of the literature in the field Dr. Demasi has come to the view, as a scientist, that the evidence to support the current consensus view on cholesterol is weak. And it’s almost certain that she can find dodgy cholesterol studies in the literature. There’s a hell of a lot of crap science out there, and equally large amounts of science being cited in support of things you can’t actually conclude from the evidence – and you don’t need to be an expert in a specific field to pick it. But refuting one of the major consensus findings of a large body of literature? Not so easy. As a scientist, she can go and engage in the field if she so chooses – returning to a research career in a different field would not be easy, but it’s certainly possible.
Instead, she appeared to be attempting to pull an Ian Plimer – bypass the field entirely and go straight to the court of public opinion. And that is both very bad science and very bad journalism.
If she’d found scientific misconduct in the field that casts into doubt key pieces of evidence, that’s a different matter – journalism is occasionally the check of last resort on dodgy high-profile science, such as William McBride’s escapades (brought to public notice by none other than Norman Swan by the way). But despite unsubstantiated and vague allegations, there was no concrete evidence of any such misconduct in the first episode.
I had two stents inserted last year and have been on statins for about 15 years. My LDL cholesterol is certainly lower than it was, but in my case the problem is genetic, not lifestyle-related. I can exercise and go on low-fat diets without statins, but nothing changes. It’s only the pills that seem to make a difference. Whether lowering LDLs from 5.5 to 2.2 has lowered my chances of a heart attack I don’t know, but I’m not keen on taking the gamble to come off the drugs and load up on deep fried Mars bars.
Mr Denmore, my problem back then was probably lifestyle related (considering my 60-year history) as well as genetic. I had three arteries clogged to 90 to 95% with 80% of my heart compromised. Luckily I didn’t have a heart attack, and so didn’t suffer muscle damage.
My cardiologist likes to have my LDL below 2%, as the arteries currently in use were not designed for the purpose. Like you exercise and diet won’t get me anywhere near. Statins didn’t quite either (about 2.1 to 2.2% over time), so he put me also on ezetimibe in a combo drug (Vytorin).
There has been no encouragement to rely on the drugs alone. I do a cardiac stress test once a year (ECG while on a treadmill). Once they made it an echocardiogram (ultrasound) which was fun!
fn and rf, there is a transcript available of the interview with Prof Clifton which talks about the odds you mention.
He emphasises that heart disease operates over 30 to 40 years. Ideally you’d need trials over longer periods starting at various ages. Most trials, they say, are only over 5 years. Seems to me you could have a situation where most of the group make it through the first 5 years but there is increasing variation from there on.
He also says that in Australia you would normally use statins when the risk of an event (rather than death) is at least 2% each year.
Clifton seems to me exactly the kind of expert Demasi should have put on the show.
I don’t enjoy Norman Swan’s programs because he is constantly cutting over and interrupting his interviewees. Rude!
Not much comment here about the likely role drug companies are playing in pushing statin drugs, using hard sell techniques (as they do). Surely it is likely that those drug companies have skewed the whole issue and it’s possible there is massive overprescribing?
I have been on statins for about a year (Lipitor) – cholesterol gradually creeping up to as high as 5.8 a year ago. Both parents suffered heart disease in their 70s (father previously had been a heavy smoker) but lived into their 90s. I am overweight but have lost 10kgs this year through modest dieting (2 days per week calorie restricted – 650 Calories based on height, weight and age). No other lifestyle related factors likely to increase my chances of developing heart disease. I am probably a low-moderate risk of developing heart disease although a stress test has already revealed some evidence of heart disease.
I watched the programs and discussed them with my GP, a cautious, responsible but open minded chap. He said he felt some of the arguments were overstated and under-supported and that the research was probably not strong enough (yet) to be unequivocal. he is inclined to accept the argument that sugar intake is a primary cause of heart disease but (if I remember him correctly did not feel that the research was conclusive yet. He believes that for those in high risk category or those who have already suffered heart attack statins were absolutely to be recommended but that statins were probably over-prescribed. For those in my intermediate category he felt it became increasingly a matter of judgement as risk fell as to whether statins are warranted or not. We agreed that I would come off the statins and monitor change in cholesterol levels.
To return to this one for a moment, I saw my GP on Friday. She didn’t ask me about the statins, but I couldn’t resist raising the topic with her. She said none of her patients on statins had raised the topic with her.
I ventured the opinion that statins were both over and under-prescribed, especially in the US. She agreed with that and said she thought there was some over-prescription here by heart specialists.
Doug @ 22, my GP uses specialist referrals quite a lot and I can’t imagine her ordering a stress test in her own right. I guess she has a clientele that doesn’t mind paying (and waiting) for specialists.
I recall it being said that no-one should have two risk factors. Thing is, being a male is already one.
I’ll mention here that I think consuming psyllium husks (from a health food shop or as Metamucil) helps in fostering the good cholesterol. (My ratio tends not to be right.) I guess I do so much stuff that I can’t isolate what works, but subjectively I think it does, for me.
I’ve also started a form of exercise that I understand helps on those days when I don’t work physically. I do it on an exercise bike. After 5 minutes warm up I rev it up for five minutes, not flat out, but at a level that can be sustained. Then warm down for five minutes. Repeat three times.
Not sure I’ve got the formula exactly right, but I’ve heard something along those lines is supposed to reduce your chance of having a heart attack.
Brian@24: Are you thinking of interval training? That’s more typically “as hard as you can for 30-60 seconds” but if you’re old and unfit what you describe sounds more survivable. It apparently does good things for your cadiovascular system, more so than just aerobic exercise.
I admit to be slightly amused at that advice because it could easily be phrased as “bike to work”. Inevitably there will a be a few places where you end up going all out just to get through something ugly in one piece. Well, ok, inevitably *I* will end up… 🙂
My cholsterol ration was not idea last time I had ti checked, because my “good cholesterol” was also low. I should go to someone who knows something about this, rather than the nurse who ran through work, to find out whether it’s actually important. I’m wary of generic advice mostly because I’m a physical outlier (typical resting pulse is up to ~50-55bpm now I’m in my 40’s, low blood pressure).
Yes Moz, I’ve chosen the “bike to work” over gym exercise, although sometimes I do wonder whether this will be the day I’ll cop Instant Death instead of cardiovascular related death!
Did anyone see the Media Watch episode on this one? Catalyst’s selection of ‘experts’ hardly come out smelling like roses. They sound more like the usual bunch of crooks featured on TT and ACA…
Transcript link here
“Grounding” anyone?
Moz, I heard about it on the radio as a research program done at that time with young prople (captive students). Then from John D who was participating in a trial with oldies at QU. I’ll check with him more precisely the next time we catch up. The odometer is working on the bike. Yesterday I did about 25K, so that can’t be all bad.
My younger son is a cyclist of sorts and worked for a time as a bike mechanic. He’d been riding in the QUT, but gave it up for a time after he nearly got wiped out by another cyclist along the Coronation Drive river reach. Another friend got badly hurt with someone opening a car door.
Now he’s riding again but tends to leave it until there’s not much around on the roads.
Jess, thanks for the link. My GP was aware of the Media Watch program but I didn’t have time to follow it up.
Karl Kruszelnicki was asked about the issue on local radio. He said, go with Norman Swan because he talks to the right people, pointing out the conflict of interest and lack of quals in the people Demasi used.
I think Maryanne Demasi blew up her reputation as a reliable journalist.
Yes, well I would think the damage to reputations extends beyond Demasi. This ‘documentary’ shouldn’t have even made it past the producer.
And based on Peter Sullivan’s account of the way they treated him, they might be lucky to get any more interviews with Australia’s distinguished researchers…