Have we Been Misled by the Evidence?
Jun 28, 2018 Dr. Maryanne Demasi is a former medical scientist who completed her PhD in Medicine at the University of Adelaide. Her research focused on the pathology of Rheumatoid arthritis and potential therapies. Her innovative research has appeared in several internationally published medical journals. Leaving her lab coat behind, Maryanne accepted a position as a political advisor and speechwriter for the South Australian Minister for Science and Information technology portfolios. She advised on issues concerning Intellectual Property and commercialisation of research. Maryanne was headhunted by the ABC ‘s Catalyst program in 2006 and gained a reputation for reporting on relevant and sometimes controversial medical stories. She has won numerous accolades for her work and in 2008, 2009 and 2011 was awarded the National Press Club of Australia’s prize for her excellence in health journalism.
Transcript
Intro
0:13Thank You Doron for inviting me here
0:16today some of you may know me from ABC’s
0:22catalyst program I was investigative
0:25journalist for ABC for about ten years
0:28until the unfortunate demise of the
0:31program about a year and a half ago when
0:33ABC decided to axe the program and the
0:37entire team was made redundant
0:39I’m a former scientist I did a PhD in
0:42rheumatology I now work as a consultant
0:46for the Nordic Cochrane Collaboration
0:48which is essentially a big consortium of
0:51scientists who do health and medical
0:53research projects and distinctly
0:57function with no industry funding I’m
1:02here today to talk about statin Wars
1:04it’s a paper a peer-reviewed narrative
1:08review that was published in the British
1:09Journal of Sports Medicine in January
1:11this year it’s called statin Wars have
1:15we been misled by the evidence so
1:17there’s the reference if you want some
1:18more detail on my talk today so a bit of
1:22background on statins they’re the most
1:25widely prescribed cholesterol-lowering
1:27drug on the planet so they’re an
1:31incredibly lucrative drug class with
1:33Pfizer’s lipitor being the most
1:36profitable drug in the history of
1:38medicine since their introduction their
1:42twenty-year patents have expired
1:45but despite the expiration of these
1:47patents the total sales is expected to
1:51reach one trillion US dollars by 2020 so
1:55there’s no doubt that the statin Empire
1:58is big business now there’s been anStatin Wars The rise of statins
2:01exponential rise in the prescribing of
2:04statins in the early days we were only
2:06prescribing statins to people at high
2:09risk of heart disease so these are
2:10people who’ve already had a heart attack
2:12or stroke with diagnosed disease then an
2:15influential group began recommending or
2:19promoting that statins be prescribed to
2:21everybody over the age of 50 even if you
2:24had normal cholesterol level
2:27a few years ago we had some pediatrician
2:29saying that we should start screening
2:31kids for high cholesterol and Pfizer
2:34ended up marketing some grape flavored
2:37statins to children and adolescents as
2:39potential recipients of these
2:42medications we had a very high-profile
2:45cardiologist in the UK who published in
2:48the American Journal of Cardiology
2:50suggesting that statins was so safe and
2:53so effective that we should offer them
2:54as condiments in burger outlets to
2:57counter the effects of a fast-food meal
3:00I’ve even interviewed people who’ve
3:03participated in debates in the US about
3:06putting statins in the water supply so
3:09this exponential rise in the prescribing
3:11of statins has caused a very large chasm
3:16between two parts of the medical
3:18profession the proponents say that
3:21statins are incredibly life-saving that
3:23they’re one of the most important
3:25advances in medical history and have
3:27prevented untold heart attacks and
3:29strokes but the other side of the
3:32spectrum has become more skeptic
3:34sceptical and they say that statins are
3:37largely unnecessary and serve no purpose
3:40in lowering cholesterol to prevent
3:42cardiac problems so who’s right and and
3:45why is it that we’ve got this bitter
3:47divide amongst a group of educated
3:51doctors who are all looking at the same
3:53literature
3:54well my proposition today is that we
3:57need to follow the money and that’s
3:59usually a proposition when you’re
4:01dealing with industries of this size the
4:04cost of developing a drug a prescription
4:07drug to gain market attention nowadays
4:08exceeds 2.5 billion US dollars so
4:13instead of developing a new drug drug
4:16companies understand that an effective
4:19way to fast-track company profits is to
4:21extend the indications of an existing
4:24drug that they already have and that’s
4:26essentially what happened with statins
4:29in the early 2000s the u.s. national
4:32cholesterol and education program simply
4:34revised their definition of high
4:37cholesterol
4:38it used to be in about 6 or 6.5 and then
4:42they lowered it gradually to 5.5 I think
4:46now it’s below 5 and so by simply just
4:49lowering the threshold of what we call
4:52high cholesterol millions more people
4:55became eligible for these medications
4:57overnight so it wasn’t based on any new
5:01science at all it was just on this
5:03prevailing view that when it comes to
5:05cholesterol the lower the better
5:10skepticism arose when it was discovered
5:12that 8 out of 9 of those people deciding
5:16to lower that threshold actually had
5:18direct financial ties to statin
5:21manufacturers in 2013 the American
5:26College of Keio lodgest sand the
5:28American Heart Association decided that
5:31they were going to move away from
5:32looking at just a single number of high
5:35cholesterol and they decided to look at
5:37a patient’s over your overall cardiac
5:39risk so if you go to a doctor nowadays
5:42they’ll usually assess the risk of
5:44developing heart disease over a period
5:47of time so these calculators take into
5:51account not only your cholesterol number
5:53but your age your blood pressure and I
5:55think weight and even if you have type 2
5:57diabetes and they come out with a number
5:59so when they moved from single
6:03cholesterol number to a percentage risk
6:07us decided that if you had a risk of
6:107.5% of developing heart disease in the
6:13next 10 years you would be prescribed a
6:15statin and that’s compared to a higher
6:18threshold in the UK of 20% so by simply
6:22changing from a single cholesterol
6:25number to this very low percentage risk
6:28profile it increased the number of
6:31Americans being prescribed statins by
6:32twelve point eight million but what was
6:36most concerning is that the majority of
6:38these people were actually elderly
6:40people without established heart disease
6:43and this is the population that would
6:45get virtually no benefit from these
6:47medic
6:47patience then there was concern about
6:51these calculators that they were perhaps
6:54overestimating the risk of the patients
6:56one study showed that four out of five
6:59of these calculators were actually
7:02overestimating the risks some up to a
7:04hundred and fifteen percent so that
7:06started really driving this
7:08overdiagnosis and overtreatment and
7:10over-prescription
7:11of statin medications and it was
7:14referred to as the statin ization of the
7:16population by Professor John Ian Edie’s
7:19a professor at Stanford University so
7:23industry bias has become a big issue in
7:27the 1980s when former President Ronald
7:30Reagan was in power he significantly
7:34slashed public funding to the National
7:37Institutes of Health and this Lepik left
7:39a gaping hole for private industry to
7:42come in and start sponsoring their own
7:44clinical trials and this is essentially
7:48what happened with the statin trials the
7:51vast majority of statin trials are
7:54funded by manufacturers so when you have
7:57drug companies sponsoring their own
8:00trials and publishing their own
8:02peer-reviewed results Cochrane has
8:06established well and truly that this
8:08favours the benefits of the drug and
8:11underestimates the risks and this is
8:13what has led the founder of the Nordic
8:16Cochrane Collaboration prefer to pick
8:17professor peter gocha to say that when
8:20the drug industry sponsors trials and
8:22cannot be examined or questioned by
8:24independent researchers that science
8:26ceases to exist and it becomes nothing
8:29more than marketing now the very nature
8:33of science is its contestability we need
8:37to be able to challenge and re challenge
8:39scientific results to ensure that
8:42they’re reproducible and they’re
8:43legitimate but there’s been a cloud of
8:46secrecy around the clinical trials on
8:50statins most people are not aware that
8:55the raw data on statin side-effects
8:59have never been released to the public
9:01is controlled by one group of
9:04researchers led by Professor RoryStatin Wars Data Secrecy & contestability of science
9:07Collins the under the CTTT collaboration
9:12which is under the sea TSU at Oxford
9:14University so they hold all the raw data
9:16on statin side-effects now this is an
9:19incredibly influential group of
9:22scientists they periodically publish
9:24meta analyses that advocate the wider
9:27use of statins this is the group that
9:29were promoting that everybody over the
9:32age of 50 even if they had normal
9:34cholesterol should be on statin
9:36medications they claim to be an
9:39independent organization but we know
9:41from internal documents that revealed to
9:43the British Medical Journal that CTS U
9:46has received over 250 at sixty million
9:50pounds from the makers of
9:52cholesterol-lowering medications now the
9:55reason they obtain this data and is
9:58because they’ve signed a legally binding
10:01agreement with the principal
10:03investigators of the clinical trials
10:05which are the drug companies and they’ve
10:07agreed to withhold the raw data from any
10:10third party and they will not permit
10:13independent researchers to verify these
10:16results so this is an egregious lack ofStatin Wars Lack of transparency
10:19transparency in science sharing data
10:23with other researchers is vital for
10:25scientific transparency because it
10:27allows for independent scientists to
10:30scrutinize the clinical trial results
10:31and then it fosters a greater confidence
10:34about the true benefits and risks of a
10:36medication now this is not just for the
10:39public who are taking these medications
10:41this is for the doctors who want to
10:44relay balanced information to their
10:47patients when they prescribe these
10:49medications they want to tell patients
10:51about the harms and the benefits of
10:54these medications so that patients are
10:56able to make informed choices about
10:59which pills they want to take so it’s
11:02not surprising that all of this secrecy
11:05around the side effects of statins has
11:08raised concerns about the authenticity
11:10of the statin data
11:13now this situation we we need to learn
11:19from situations in the past and Tamiflu
11:22is a prime example of a medication where
11:25governments around the world spent
11:27millions and millions of dollars
11:29stockpiling this medication in the event
11:32of a flu pandemic based on information
11:34that we got from the drug companies that
11:36it shortened the span of having the flu
11:39and that it reduced Hospital
11:40complications but a tenacious group of
11:43Cochrane researchers lobbied hard to get
11:46access to the clinical trial reports
11:48that the drug companies had never
11:51revealed to the public and it took
11:54several years but in a essentially a
11:57public shaming campaign in collaboration
12:01with the British Medical Journal the
12:03drug companies finally handed over that
12:04data and the Cochrane researchers did do
12:07an independent review and they found
12:09that Tamiflu was not as effective as it
12:15was made out to be that it had much more
12:17side-effects and it didn’t reduce
12:18Hospital complications so this was a
12:24very revealing lesson when we learned
12:27that Tamiflu was probably no better than
12:29taking ordinary cheap paracetamol when
12:33you get the flu another way that you can
12:41influence public opinion and doctors
12:44opinions about the efficacy of statin
12:49medications is to design a trial to
12:52minimize the harms and this is
12:55essentially what happened in the heart
12:56protection study they design a trial
12:59with what they call a run-in period so
13:02they gather say you know thousands of
13:05participants and they put all the
13:06participants on the drug for a period of
13:10four to six weeks then at the end of
13:14this run-in period there’s a high
13:17dropout rate people stop taking the
13:19medication that I tolerate it mostly due
13:22to side effects in the heart protection
13:24study
13:2536% of the participants dropped out in
13:28this first phase of the trial
13:30so with this freshly cold population of
13:33participants that’s when they begin the
13:36clinical trial and they separate them
13:38between placebo and statins so at the
13:40end the side effect rates between the
13:44statin group and the placebo group are
13:46fairly similar so we know that cutting
13:50out all of those people that had side
13:52effects from the medication before the
13:54trial began grossly underestimate s’ the
13:56percentage of people that will
13:58experience side effects at the end of
13:59the trial and this is probably why we
14:02see that the side effect rate in the
14:05statin trials is wildly different to the
14:08rates that we see in real world
14:10populations so when you ask doctors what
14:13the complication and side-effect rates
14:16are as statins they usually say around
14:1820 to 30 percent of their patients feel
14:20muscle pain and brain fog another way
14:25that a drug company can market the
14:28medication and exaggerate the benefits
14:31is to exaggerate the statistics now most
14:34of you have heard doctors and public
14:38health authorities say that statins
14:39reduce your risk of developing heart
14:41disease by over 30% now in Australia
14:45direct-to-consumer advertising is
14:48illegal but it’s not illegal to
14:50advertise direct to doctors and this is
14:53the kind of advertisement that you’ll
14:55see in a doctor magazine this is an
14:57Australian doctor publication it says
15:00lipitor reduces the risk of heart attack
15:02by 36 percent and they have a picture of
15:05an imminent and trustworthy doctor and
15:07why wouldn’t you relay that to your
15:09patients I’d be impressed with a
15:11medication that would reduce my risk by
15:1436 percent but when you look closer at
15:17the study this is the study it came fromStatin Wars Exaggerating statistics
15:20from 2008 it was published in the
15:23European Heart Journal and again Rory
15:26Collins appears on this publication and
15:29on table 4 it actually shows that if you
15:31take placebo your risk of having a heart
15:35attack is about 3.1
15:38it so this is taking the sugar pill
15:40however if you take the statin your risk
15:44drops to two percent so from three point
15:48one percent down to two percent is about
15:50a thirty six percent reduction but the
15:53absolute risk reduction was only one
15:56point one percent and that sounds much
15:58less impressive especially to a patient
16:01when they’re talking to their doctor
16:02about whether they want to take statins
16:03now the reason this is really important
16:06for patients is because they they have
16:09the fear of God put in them that you’re
16:11going to die if you stop taking your
16:13statins but these kind of statistics
16:16will just help the patient make more
16:19informed choices about whether or not
16:20they want to take a medication because
16:21if they’re suffering really badly from
16:24side effects they have severe muscle
16:25pain and they can’t exercise they have
16:28brain fog they have memory lapses they
16:30can’t function properly at work then
16:32maybe some of them are willing to take
16:34the risk of this absolute reduction of
16:371.1% so it’s important to give patients
16:39honest and transparent information one
16:46of the ways in which drug companies can
16:48effectively influence public opinion and
16:51it’s a powerful way is to silence
16:54dissenters one of the ways to do this is
16:58scientific publications in 2016 there
17:02was a 30 page review authored by
17:06Professor Rory Collins again in a very
17:09high-profile journal called The Lancet
17:11it claimed to end debate once and for
17:14all
17:15statins were safe and not to listen to
17:17any media hype because these medications
17:21are wonderful even for people at low
17:24risk of heart disease
17:25so this received widespread media
17:27attention and most of the news coverage
17:32in the UK the US and Australia even
17:36widely publicized this view another wayStatin Wars Silence the dissenters
17:40to silence the Centers is to discredit
17:42them now professor Rory Collins in a UK
17:46outlet said that those who questioned
17:49statin side-effects
17:51a far worse and have probably killed
17:53more people than the paper on the MMR
17:56vaccine so again accusing you of
17:58murdering people as an effective way at
18:01trying to discredit you a professor
18:03Steve Nissen from the Cleveland Clinic
18:05also said that we need to push back on
18:07people challenging statins and he he
18:11said that it was a rise in the internet
18:13cult so calling you a cult leader or a
18:16cult follower it’s an effective way to
18:18discredit you and lastly one of the most
18:24effective ways to silence dissenting
18:27views is about censorship and we’ve
18:30heard a lot about Gary fitt key which
18:32many of you would know so I won’t go
18:34into much of that now but I’ll just talk
18:37really briefly about my experience at
18:39ABC catalyst program so in 2013 I did a
18:45two-part series called heart of the
18:48matter and just a show of hands who’s
18:50familiar with this controversy that
18:52happened okay so a lot of you like I’m
18:56preaching to the converted so really
18:59briefly it was a two-part series the
19:02first challenge the long-held belief
19:04that saturated fat caused heart disease
19:06by raising cholesterol and the second
19:08part of the series which was the one
19:10that caused all the controversy was
19:12called cholesterol drug wars and we
19:14questioned the over prescription of
19:16statins and the overwhelming industry
19:21influence in statin trials they went to
19:23air they received an extraordinary
19:25amount of attention they rated 1.5
19:28million which was profound ratings at
19:31the time at that time slot and we were
19:33receiving thousands of congratulatory
19:36letters and texts and on social media
19:39from people that were really happy with
19:41us and of course and more importantly
19:43the managing director and director of
19:46television ABC were really pleased about
19:48the outcome of these trials these
19:51programs until we started receiving
19:56complaints from art foundation who were
19:59criticized in this program very scathing
20:02complaints and from
20:03of course the drug companies and a few
20:06vested interest groups so this is when
20:09the orchestrated campaign to discredit
20:11myself when the program’s began we hadStatin Wars Scare campaign – Australia
20:14ABC’s health commentator Norman Swan go
20:16on national radio and say people will
20:18die if they watch this program we had a
20:22Sydney cardiologist Royal Prince Alfred
20:24David Salaam I go to to The Sydney
20:26Morning Herald and say ABC has blood on
20:29its hands cardiologist dr. Peter Clifton
20:32he is a he was paid a sponsor on med
20:37Olli marjorine and has received money
20:40from the sugar industry coca-cola in the
20:43medical observer he encouraged people to
20:45contact Slater and Gordon and sue the
20:48ABC if anybody had watched the program
20:50program and gone off their statins and
20:52had a heart attack and of course a
20:55scathing review by the National Heart
20:57Foundation CEO she wrote an editorial in
21:01The Sydney Morning Herald saying that
21:02the program and the messages were
21:05dangerous and this was a really
21:07difficult tide to stop or at least
21:10counter because our entire catalyst team
21:14were put under a gag order we were not
21:16allowed to defend ourselves in the media
21:18so this criticism kind of avalanched and
21:21it took on a life of its own and then of
21:24course very widespread media attention
21:30on an article that was published by
21:34Professor Emily Banks in the Medical
21:35Journal of Australia saying that the
21:37catalyst program caused thousands of
21:39people to stop taking their medication
21:40and they predicted that this would cause
21:43up to 2,900 potentially fatal heart
21:47attacks and strokes so that was kind of
21:49the final nail in the coffin for the
21:51programs we were accused of mass murder
21:54unfortunately ABC capitulated to the
21:58pressure and the the increased scrutiny
22:01and they decided to remove the programs
22:05from the website so overall it was a
22:08real disservice to the public discourse
22:12on statins we wanted people to go to
22:15their doctor and question their medic
22:16and become more educated about their
22:18medications but we were being bombarded
22:20by doctors saying how dare these
22:23patients come into my clinic and
22:26question me about prescribing men statin
22:29medications I was at war that was
22:32exactly the point of the program why are
22:34you so upset I’ll just mention briefly
22:39this campaign scare campaign that
22:43happened in France because it was very
22:44similar to what happened to me but it
22:46had a slightly different outcome
22:48so again widespread media attention when
22:51a French cardiologist questioned the
22:53value of statins in a new book and this
22:55received a lot of attention in the
22:57French press same sort of thing again a
23:00report came out blaming the book and the
23:03media hype for causing a 50% increase in
23:06statin discontinuation so lots of people
23:09going off their statins and they started
23:11making predictions and extrapolations
23:13that this would cause 10,000 deaths so
23:15extraordinary amount of people were
23:17expected to die and following year
23:20because of this media hype but this time
23:23researchers actually went back to the
23:25national statistics as opposed to just
23:28sort of calculating a predicted number
23:31of deaths that would happen in the
23:32future and the national statistics
23:35showed that the number of deaths
23:37decreased in the year following all of
23:39this media hype and so it led the
23:41authors to conclude that it was not
23:44evidence-based to claim that statin
23:46discontinuation increases mortality in
23:49that in future scientists should assess
23:51the real or actual effects of statin
23:54discontinuation rather than making
23:56dubious extrapolations and calculations
23:59so that’s where I’ll end thank you
24:02everybody for listening
24:04[Music]
24:08[Applause]
