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

Thank you Doron for having me here today, some of you may know me from the ABC Catalyst show. I was an investigative journalist for ABC for about ten years until the show's unfortunate demise about a year and a half ago, when ABC decided to ax the show and the entire team was made redundant. I am a former scientist. I did a PhD in rheumatology. I now work as a consultant for the Nordic Cochrane Collaboration, which is essentially a large consortium of scientists doing medical and health research projects and clearly operating without industry. funding I'm here today to talk about the

statin

wars

.

It's an article, a peer-reviewed narrative review that was published in the British Journal of Sports Medicine in January of this year. It's called the Statin Wars. Have we

been

fooled by the

evidence

? So there's the reference if you want more details on my talk today, so a little background on

statin

s: they're the most prescribed cholesterol-lowering drug on the planet, so they're an incredibly lucrative class of drugs, Pfizer's Lipitor being the most profitable drug in history. of drugs since its introduction, its twenty-year patents

have

expired, but despite the expiration of these patents, total sales are expected to reach one trillion US dollars by 2020, so there is no doubt that the empire of statins is big business now there has

been

an exponential increase in prescribing statins in the early days we only prescribed statins to people at high risk of heart disease so these are people who

have

already had a heart attack or a stroke with a diagnosed disease, then an influential group began recommending or promoting prescribing statins. to everyone over 50 years old, even if they had a normal cholesterol level.

A few years ago, a pediatrician said we should start testing kids for high cholesterol, and Pfizer ended up marketing some grape-flavored statins to children and teens as potential recipients of them. medications, we had a very high-profile cardiologist in the United Kingdom who published in the American Journal of Cardiology suggesting that statins were so safe and so effective that we should offer them as condiments in hamburger restaurants to counteract the effects of a fast meal. I've even interviewed people who have participated in debates in the US about introducing statins into the water supply, so this exponential increase in statin prescribing has caused a very large chasm between two parts of the profession medical.

Proponents say that statins are incredibly life-saving, are one of the most important advances in medical history and have prevented countless heart attacks and strokes, but the other side of the spectrum has become more skeptical and say that statins are in They are largely unnecessary and do little to lower cholesterol to prevent heart problems, so who is right and why do we have this bitter division between a group of educated doctors who all look at the same literature? Well, my proposal today is that we should follow the money and that is generally A proposal when it comes to industries of this size, the cost of developing a drug, a prescription drug to attract the attention of the market today, exceeds 2.5 billion of US dollars, so instead of developing a new drug, pharmaceutical companies understand that it is an effective way to accelerate the company.

The gains are expanding the indications of an existing drug that they already have and that's essentially what happened with statins in the early 2000s in the US. The National Cholesterol and Education Program simply revised their definition of high cholesterol. It used to be around 6 or 6.5 and then they gradually reduced it to 5.5. I think it's now below 5 and therefore just lowering the threshold of what we call millions of high cholesterol. More people became eligible for these drugs overnight, so it wasn't based on any new science, but simply this prevailing opinion that when it comes to cholesterol, the lower the better, skepticism arose when it came to cholesterol. found that 8 out of 9 of those people who decided to lower that threshold actually had direct financial ties to statin manufacturers.

In 2013, the American College of Keio and the American Heart Association decided that they were going to stop looking at just a single high cholesterol number and decided to look. in a patient above their overall heart risk, so if you go to a doctor today, they will generally assess your risk of developing heart disease over a period of time, so these calculators take into account not just your level cholesterol but also your age, your blood pressure and I think weight, and even if you have type 2 diabetes, they give you a number, so when they went from the single cholesterol number to a percentage risk, we 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 compares to a higher threshold in the UK of 20%, so simply switching from a single cholesterol number to this very low percentage risk profile increased the number of Americans who were Twelve point eight million were prescribed statins, but most worryingly, the majority of these people were actually older people without established heart disease and this is the population that would get virtually no benefit from these medical calculators.

So there was concern that these calculators were overestimating the risk of the disease. A study of patients showed that four out of five of these calculators were actually overestimating the risks by up to one hundred and fifteen percent, so it really started to drive this overdiagnosis, overtreatment, and overprescription of statin drugs and it became known as statinization. . of the population by Professor John Ian Edie at Stanford University, so industry bias has become a big problem in the 1980s, when former President Ronald Reagan was in power, he significantly cut the public funding to the National Institutes of Health and this Lepik left a huge hole. for private industry to come in and start sponsoring their own clinical trials and this is essentially what happened with statin trials, the vast majority of statin trials are funded by the manufacturers so when you have pharmaceutical companies sponsoring their own trials and publish their own peer-reviewed results Cochrane has shown with certainty that this favors the benefits of the drug and underestimates the risks and this is what has led the founder of the Nordic Cochrane Collaboration to prefer to choose Professor Peter gocha to say that when the pharmaceutical industry sponsors trials and cannot be examined or questioned by independent researchers that science ceases to exist and 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 they are reproducible and are It is legitimate, but there has been a cloud of secrecy around statin clinical trials, most people are not aware that the raw data on statin side effects have never been made public and are controlled by a group of researchers led by Professor Rory Collins, under the name of the CTTT Collaboration which is under the TSU Sea at the University of Oxford, so they contain all the raw data on the effects side effects of statins.

Now this is an incredibly influential group of scientists. They regularly publish meta-analyses advocating for broader use of statins. This is the group promoting that everyone over 50, even if they had normal cholesterol, should take statins. They claim to be an independent organization, but we know from internal documents revealed to the British Medical Journal that CTS U has received more than 250 million pounds. of the cholesterol-lowering drug manufacturers now the reason they get this data is because they signed a legally binding agreement with the principal investigators of the clinical trials, which are the pharmaceutical companies, and agreed to retain the raw data from any third parties and they will not allow independent researchers to verify these results, so this is a blatant lack of transparency in science.

Sharing data with other researchers is vital to scientific transparency because it allows independent scientists to examine the results of clinical trials and then fosters greater confidence about the true benefits and risks of a drug. Now this is not just for the public taking these medications This is for doctors who want to convey balanced information to their patients when prescribing these medications who want to inform patients of the harms and benefits of these medications so that patients can make informed decisions about which pills they want to take, so it is not Surprisingly, all this secrecy around statin side effects has raised concerns about the authenticity of statin data.

In this situation, we must learn from past situations and Tamiflu is a great example of a drug where governments around the world spent millions and millions of dollars to stockpile this drug in case of a flu pandemic, according to the information that The drug companies said it shortened the duration of the flu and reduced hospital complications, but a tenacious group of Cochrane researchers lobbied hard to gain access to clinical trial reports that the drug companies had never disclosed to the public and took several years, but In an essentially public shaming campaign in collaboration with the British Medical Journal, the pharmaceutical companies finally turned over that data and Cochrane researchers did an independent review and found that Tamiflu was not as effective as believed. many more side effects and did not reduce hospital complications, so it was a very eye-opening lesson when we learned that Tamiflu was probably no better than taking regular, cheap paracetamol when you get the flu, another way to influence public opinion and opinions of doctors. regarding the effectiveness of statins is to design a trial to minimize harm 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 thousands of participants and say they know. I put all participants on the medication for a period of four to six weeks and then at the end of this run-in period there is a high dropout rate. People stop taking the medication I tolerate mainly because of side effects in the heart protection study 36% of participants dropped out in this first phase of the trial, so this population of participants who just had a cold is when they start the trial clinical and separate them between placebo and statins, so in the end the rates of side effects between the statin group and the placebo group are quite similar, so we know that eliminating all those people who had side effects from the drug before starting the trial greatly underestimates the percentage of people who will experience side effects at the end of the trial and this is probably why We see that the rate of side effects in statin trials is wildly different from the rates we see in real world populations So when you ask doctors what the complication and side effect rates are for statins, they typically say that 20 to 30 percent of their patients feel muscle pain and brain fog.

Another way a pharmaceutical company can market the drug and exaggerate the benefits is to exaggerate the statistics. Now most of you have heard doctors and public health authorities say that statins reduce the risk of developing heart disease by more than 30%. Now in Australia direct-to-consumer advertising is illegal, but it is not illegal to advertise directly to doctors and this is the type of advertising you will see in a doctors' magazine. This is a post from Australian doctors saying that Lipitor reduces the risk of heart attack by 36 percent and they have an image of an imminent and trustworthy doctor and why not pass that on to their patients?

I would be impressed with a drug that would reduce my risk by 36 percent, but when you look closer at the study this is the study it came from in 2008, it was published in the European Heart Journal and again Rory Collins appears in this publication and in the table 4 actually shows that if you take placebo your risk of having a heart attack is about 3.1. This is taking the sugar pill, however, if you take a statin, your risk is reduced to two percent, sofrom three point one percent to two percent is about a thirty-six percent reduction, but the absolute risk reduction was only one point one percent and that sounds like a lot. less impressive, especially for a patient when talking to his doctor about whether he wants to take statins now.

The reason this is really important to patients is because they have the fear of God that they are going to die if you stop taking your statins, but these types of statistics will only help the patient make more informed decisions about whether they want to or not. take a medication because if you suffer a lot from the side effects, you have severe muscle pain and you can't. they exercise they have brain fog they have memory lapses they can't function properly at work so maybe some of them are willing to take the risk of this 1.1% absolute reduction, so it's important to give patients honest and Transparent is one of the ways pharmaceutical companies can effectively influence public opinion and is a powerful way to silence dissidents.

One of the ways to do this is scientific publications. In 2016 there was a 30 page review written again by Professor Rory Collins in a very high profile journal called The Lancet claiming to end the debate once and for all: statins were safe and we didn't hear any media hype because these drugs 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 United States and Australia even widely publicized this view. Another way to silence the Centers is to discredit them. Professor Rory Collins in a UK media said that those who questioned the side effects of statins are much worse and have probably killed more people than the MMR vaccine article, so he again accused him of murdering people as a effective way to try to discredit it, so does Professor Steve Nissen of the Cleveland Clinic. he said we have to push back against people who challenge statins and he said this was a rise in the internet cult, so calling you a cult leader or a cult follower is an effective way to discredit you and lastly , one of the most effective ways to Silence dissenting opinions has to do with censorship and we've heard a lot about Gary Fitt Key, which many of you would know, so I won't go into that too much now, but I'll just talk very briefly about myself experience in ABC's catalyst program. in 2013 I did a two part series called The Heart of the Matter and just raised your hand who is familiar with this controversy that happened well many of you like that I am preaching to the converted very briefly it was a two part series parts. series the first challenged the long-held belief that saturated fats caused heart disease by raising cholesterol and the second part of the series that caused all the controversy was called cholesterol drug

wars

and we questioned the overprescription of statins and the overwhelming influence of industry on statin trials.

They went on air. They received an extraordinary amount of attention. They rated 1.5 million, which was a deep rating at that time, at that time, and we received thousands of congratulatory letters and text messages on social media from people who were really happy with us and, of course, and we More importantly, the CEO and the director of ABC television were very satisfied with the outcome of these tests and these programs until we started receiving complaints from the art foundation that were criticized in this program, very scathing complaints and, therefore, Of course, from the pharmaceutical companies and some vested interest groups, so that was when the campaign to discredit me was orchestrated when the program began.

We had ABC health commentator Norman Swan go on national radio and say people would die if they watched this programme. We had a cardiologist from Sydney, the Prince Royal. Alfred David Salaam I go to the Sydney Morning Herald and say ABC has blood on its hands, cardiologist dr. Peter Clifton, was paid as an endorser for Med Olli Marjorine and received money from the Coca-Cola sugar industry. On Medical Observer, he encouraged people to contact Slater and Gordon and sue ABC if anyone had seen the show and left. he went off his statins and had a heart attack and, of course, a scathing review from the CEO of the National Heart Foundation.

She wrote an editorial in The Sydney Morning Herald saying that the program and the messages were dangerous and that this was a really difficult tide to stem or at least against. Because our entire catalyst team was placed under gag order, it was not allowed us to defend ourselves in the media, so this criticism kind of avalanched and took on a life of its own and then, of course, very extensive 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 medications and predicted that this would cause up to 2,900 potentially fatal heart attacks and strokes, so that was the final nail in the coffin of the programs they accused us of murdering en masse, sadly ABC capitulated to the pressure and increased scrutiny and decided to remove the shows from the website, so overall it was a disservice to the public discourse about statins that we wanted people to use. to their doctor and ask their doctor and educate us more about their medications, but the doctors bombarded us saying how dare these patients come to my clinic and ask me about prescribing statins for men.

It was at war, that was exactly the goal of the program. Why are you so upset? I will only briefly mention this terror campaign that occurred in France because it was very similar to what happened to me, but it had a slightly different outcome, so again widespread media attention was made when a French cardiologist questioned the value of statins. in a new book and this received a lot of attention in the French press. Again a report came out blaming the book and media hype for causing a 50% increase in statin discontinuation, so many people stopped taking them and we started making predictions and extrapolations that this would cause 10,000 deaths, so which an extraordinary number of people were expected to die and the following year because of this media hype, but this time the researchers went back to national statistics instead of simply calculating an expected number of deaths that would occur in the future and national statistics showed that the number of deaths decreased in the year following all this media hype, leading the authors to conclude that it was not

evidence

-based to claim that stopping statins increases mortality in that in the future scientists should evaluate the true or actual effects of stopping statins rather than making extrapolations and dubious calculations, so that's where I'll end, thanks everyone for listening.