Dr. Maryanne Demasi - 'Statin Wars: Have we been misled by the evidence?'

Thank You Doron for inviting me here today some of you may know me from ABC's catalyst program I was investigative journalist for ABC for about ten years until the unfortunate demise of the program about a year and a half ago when ABC decided to axe the program and the entire team was made redundant I'm a former scientist I did a PhD in rheumatology I now work as a consultant for the Nordic Cochrane Collaboration which is essentially a big consortium of scientists who do health and medical research projects and distinctly function with no industry funding I'm here today to talk about statin Wars it's a paper a peer-reviewed narrative review that was published in the British Journal of Sports Medicine in January this year it's called statin Wars have we been misled by the evidence so there's the reference if you want some more detail on my talk today so a bit of background on statins they're the most widely prescribed cholesterol-lowering drug on the planet so they're an incredibly lucrative drug class with Pfizer's lipitor being the most profitable drug in the history of medicine since their introduction their twenty-year patents have expired but despite the expiration of these patents the total sales is expected to reach one trillion US dollars by 2020 so there's no doubt that the statin Empire is big business now there's been an exponential rise in the prescribing of statins in the early days we were only prescribing statins to people at high risk of heart disease so these are people who've already had a heart attack or stroke with diagnosed disease then an influential group began recommending or promoting that statins be prescribed to everybody over the age of 50 even if you had normal cholesterol level a few years ago we had some pediatrician saying that we should start screening kids for high cholesterol and Pfizer ended up marketing some grape flavored statins to children and adolescents as potential recipients of these medications we had a very high-profile cardiologist in the UK who published in the American Journal of Cardiology suggesting that statins was so safe and so effective that we should offer them as condiments in burger outlets to counter the effects of a fast-food meal I've even interviewed people who've participated in debates in the US about putting statins in the water supply so this exponential rise in the prescribing of statins has caused a very large chasm between two parts of the medical profession the proponents say that statins are incredibly life-saving that they're one of the most important advances in medical history and have prevented untold heart attacks and strokes but the other side of the spectrum has become more skeptic sceptical and they say that statins are largely unnecessary and serve no purpose in lowering cholesterol to prevent cardiac problems so who's right and and why is it that we've got this bitter divide amongst a group of educated doctors who are all looking at the same literature well my proposition today is that we need to follow the money and that's usually a proposition when you're dealing with industries of this size the cost of developing a drug a prescription drug to gain market attention nowadays exceeds 2.5 billion US dollars so instead of developing a new drug drug companies understand that an effective way to fast-track company profits is to extend the indications of an existing drug that they already have and that's essentially what happened with statins in the early 2000s the u.s. national cholesterol and education program simply revised their definition of high cholesterol it used to be in about 6 or 6.5 and then they lowered it gradually to 5.5 I think now it's below 5 and so by simply just lowering the threshold of what we call high cholesterol millions more people became eligible for these medications overnight so it wasn't based on any new science at all it was just on this prevailing view that when it comes to cholesterol the lower the better skepticism arose when it was discovered that 8 out of 9 of those people deciding to lower that threshold actually had direct financial ties to statin manufacturers in 2013 the American College of Keio lodgest sand the American Heart Association decided that they were going to move away from looking at just a single number of high cholesterol and they decided to look at a patient's over your overall cardiac risk so if you go to a doctor nowadays they'll usually assess the risk of developing heart disease over a period of time so these calculators take into account not only your cholesterol number but your age your blood pressure and I think weight and even if you have type 2 diabetes and they come out with a number so when they moved from single cholesterol number to a percentage risk us decided that if you had a risk of 7.5% of developing heart disease in the next 10 years you would be prescribed a statin and that's compared to a higher threshold in the UK of 20% so by simply changing from a single cholesterol number to this very low percentage risk profile it increased the number of Americans being prescribed statins by twelve point eight million but what was most concerning is that the majority of these people were actually elderly people without established heart disease and this is the population that would get virtually no benefit from these medic patience then there was concern about these calculators that they were perhaps overestimating the risk of the patients one study showed that four out of five of these calculators were actually overestimating the risks some up to a hundred and fifteen percent so that started really driving this overdiagnosis and overtreatment and over-prescription of statin medications and it was referred to as the statin ization of the population by Professor John Ian Edie's a professor at Stanford University so industry bias has become a big issue in the 1980s when former President Ronald Reagan was in power he significantly slashed public funding to the National Institutes of Health and this Lepik left a gaping hole for private industry to come in and start sponsoring their own clinical trials and this is essentially what happened with the statin trials the vast majority of statin trials are funded by manufacturers so when you have drug companies sponsoring their own trials and publishing their own peer-reviewed results Cochrane has established well and truly that this favours the benefits of the drug and underestimates the risks and this is what has led the founder of the Nordic Cochrane Collaboration prefer to pick professor peter gocha to say that when the drug industry sponsors trials and cannot be examined or questioned by independent researchers that science ceases to exist and it becomes nothing more than marketing now the very nature of science is its contestability we need to be able to challenge and re challenge scientific results to ensure that they're reproducible and they're legitimate but there's been a cloud of secrecy around the clinical trials on statins most people are not aware that the raw data on statin side-effects have never been released to the public is controlled by one group of researchers led by Professor Rory Collins the under the CTTT collaboration which is under the sea TSU at Oxford University so they hold all the raw data on statin side-effects now this is an incredibly influential group of scientists they periodically publish meta analyses that advocate the wider use of statins this is the group that were promoting that everybody over the age of 50 even if they had normal cholesterol should be on statin medications they claim to be an independent organization but we know from internal documents that revealed to the British Medical Journal that CTS U has received over 250 at sixty million pounds from the makers of cholesterol-lowering medications now the reason they obtain this data and is because they've signed a legally binding agreement with the principal investigators of the clinical trials which are the drug companies and they've agreed to withhold the raw data from any third party and they will not permit independent researchers to verify these results so this is an egregious lack of transparency in science sharing data with other researchers is vital for scientific transparency because it allows for independent scientists to scrutinize the clinical trial results and then it fosters a greater confidence about the true benefits and risks of a medication now this is not just for the public who are taking these medications this is for the doctors who want to relay balanced information to their patients when they prescribe these medications they want to tell patients about the harms and the benefits of these medications so that patients are able to make informed choices about which pills they want to take so it's not surprising that all of this secrecy around the side effects of statins has raised concerns about the authenticity of the statin data now this situation we we need to learn from situations in the past and Tamiflu is a prime example of a medication where governments around the world spent millions and millions of dollars stockpiling this medication in the event of a flu pandemic based on information that we got from the drug companies that it shortened the span of having the flu and that it reduced Hospital complications but a tenacious group of Cochrane researchers lobbied hard to get access to the clinical trial reports that the drug companies had never revealed to the public and it took several years but in a essentially a public shaming campaign in collaboration with the British Medical Journal the drug companies finally handed over that data and the Cochrane researchers did do an independent review and they found that Tamiflu was not as effective as it was made out to be that it had much more side-effects and it didn't reduce Hospital complications so this was a very revealing lesson when we learned that Tamiflu was probably no better than taking ordinary cheap paracetamol when you get the flu another way that you can influence public opinion and doctors opinions about the efficacy of statin medications is to design a trial to minimize the harms and this is essentially what happened in the heart protection study they design a trial with what they call a run-in period so they gather say you know thousands of participants and they put all the participants on the drug for a period of four to six weeks then at the end of this run-in period there's a high dropout rate people stop taking the medication that I tolerate it mostly due to side effects in the heart protection study 36% of the participants dropped out in this first phase of the trial so with this freshly cold population of participants that's when they begin the clinical trial and they separate them between placebo and statins so at the end the side effect rates between the statin group and the placebo group are fairly similar so we know that cutting out all of those people that had side effects from the medication before the trial began grossly underestimate s' the percentage of people that will experience side effects at the end of the trial and this is probably why we see that the side effect rate in the statin trials is wildly different to the rates that we see in real world populations so when you ask doctors what the complication and side-effect rates are as statins they usually say around 20 to 30 percent of their patients feel muscle pain and brain fog another way that a drug company can market the medication and exaggerate the benefits is to exaggerate the statistics now most of you have heard doctors and public health authorities say that statins reduce your risk of developing heart disease by over 30% now in Australia direct-to-consumer advertising is illegal but it's not illegal to advertise direct to doctors and this is the kind of advertisement that you'll see in a doctor magazine this is an Australian doctor publication it says lipitor reduces the risk of heart attack by 36 percent and they have a picture of an imminent and trustworthy doctor and why wouldn't you relay that to your patients I'd be impressed with a medication that would reduce my risk by 36 percent but when you look closer at the study this is the study it came from from 2008 it was published in the European Heart Journal and again Rory Collins appears on this publication and on table 4 it actually shows that if you take placebo your risk of having a heart attack is about 3.1 it so this is taking the sugar pill however if you take the statin your risk drops to two percent so from three point one percent down to two percent is about a thirty six percent reduction but the absolute risk reduction was only one point one percent and that sounds much less impressive especially to a patient when they're talking to their doctor about whether they want to take statins now the reason this is really important for patients is because they they have the fear of God put in them that you're going to die if you stop taking your statins but these kind of statistics will just help the patient make more informed choices about whether or not they want to take a medication because if they're suffering really badly from side effects they have severe muscle pain and they can't exercise they have brain fog they have memory lapses they can't function properly at work then maybe some of them are willing to take the risk of this absolute reduction of 1.1% so it's important to give patients honest and transparent information one of the ways in which drug companies can effectively influence public opinion and it's a powerful way is to silence dissenters one of the ways to do this is scientific publications in 2016 there was a 30 page review authored by Professor Rory Collins again in a very high-profile journal called The Lancet it claimed to end debate once and for all statins were safe and not to listen to any media hype because these medications are wonderful even for people at low risk of heart disease so this received widespread media attention and most of the news coverage in the UK the US and Australia even widely publicized this view another way to silence the Centers is to discredit them now professor Rory Collins in a UK outlet said that those who questioned statin side-effects a far worse and have probably killed more people than the paper on the MMR vaccine so again accusing you of murdering people as an effective way at trying to discredit you a professor Steve Nissen from the Cleveland Clinic also said that we need to push back on people challenging statins and he he said that it was a rise in the internet cult so calling you a cult leader or a cult follower it's an effective way to discredit you and lastly one of the most effective ways to silence dissenting views is about censorship and we've heard a lot about Gary fitt key which many of you would know so I won't go into much of that now but I'll just talk really briefly about my experience at ABC catalyst program so in 2013 I did a two-part series called heart of the matter and just a show of hands who's familiar with this controversy that happened okay so a lot of you like I'm preaching to the converted so really briefly it was a two-part series the first challenge the long-held belief that saturated fat caused heart disease by raising cholesterol and the second part of the series which was the one that caused all the controversy was called cholesterol drug wars and we questioned the over prescription of statins and the overwhelming industry influence in statin trials they went to air they received an extraordinary amount of attention they rated 1.5 million which was profound ratings at the time at that time slot and we were receiving thousands of congratulatory letters and texts and on social media from people that were really happy with us and of course and more importantly the managing director and director of television ABC were really pleased about the outcome of these trials these programs until we started receiving complaints from art foundation who were criticized in this program very scathing complaints and from of course the drug companies and a few vested interest groups so this is when the orchestrated campaign to discredit myself when the program's began we had ABC's health commentator Norman Swan go on national radio and say people will die if they watch this program we had a Sydney cardiologist Royal Prince Alfred David Salaam I go to to The Sydney Morning Herald and say ABC has blood on its hands cardiologist dr. Peter Clifton he is a he was paid a sponsor on med Olli marjorine and has received money from the sugar industry coca-cola in the medical observer he encouraged people to contact Slater and Gordon and sue the ABC if anybody had watched the program program and gone off their statins and had a heart attack and of course a scathing review by the National Heart Foundation CEO she wrote an editorial in The Sydney Morning Herald saying that the program and the messages were dangerous and this was a really difficult tide to stop or at least counter because our entire catalyst team were put under a gag order we were not allowed to defend ourselves in the media so this criticism kind of avalanched and it took on a life of its own and then of course very widespread media attention on an article that was published by Professor Emily Banks in the Medical Journal of Australia saying that the catalyst program caused thousands of people to stop taking their medication and they predicted that this would cause up to 2,900 potentially fatal heart attacks and strokes so that was kind of the final nail in the coffin for the programs we were accused of mass murder unfortunately ABC capitulated to the pressure and the the increased scrutiny and they decided to remove the programs from the website so overall it was a real disservice to the public discourse on statins we wanted people to go to their doctor and question their medic and become more educated about their medications but we were being bombarded by doctors saying how dare these patients come into my clinic and question me about prescribing men statin medications I was at war that was exactly the point of the program why are you so upset I'll just mention briefly this campaign scare campaign that happened in France because it was very similar to what happened to me but it had a slightly different outcome so again widespread media attention when a French cardiologist questioned the value of statins in a new book and this received a lot of attention in the French press same sort of thing again a report came out blaming the book and the media hype for causing a 50% increase in statin discontinuation so lots of people going off their statins and they started making predictions and extrapolations that this would cause 10,000 deaths so extraordinary amount of people were expected to die and following year because of this media hype but this time researchers actually went back to the national statistics as opposed to just sort of calculating a predicted number of deaths that would happen in the future and the national statistics showed that the number of deaths decreased in the year following all of this media hype and so it led the authors to conclude that it was not evidence-based to claim that statin discontinuation increases mortality in that in future scientists should assess the real or actual effects of statin discontinuation rather than making dubious extrapolations and calculations so that's where I'll end thank you everybody for listening [Music] [Applause]

Channel: Low Carb Down Under

Views: 1,125,096

Rating: 4.9060144 out of 5

Keywords: Low Carb Down Under, LCDU, www.lowcarbdownunder.com.au, Low Carb Sydney 2018, #LowCarbSyd, Catalyst, Maryanne Demasi, Heart of the Matter, Statins, Lipitor, British Medical Journal

Id: BzTjPuikhQE

Length: 24min 10sec (1450 seconds)

Published: Thu Jun 28 2018

Reddit Comments

[u/WunderkindErinaceous]

How comes the advocates for this line of thinking are so hot? Is it bacon?

Sorry.

I love your work and your presentation Maryanne. A thought to Nina too. You are incredibly brave and thoughtful people. Thank you so much.

[u/azur08]

This is scary shit