Evidence-Based Medicine or Evidence-Based Marketing
Well, this week we had a tremendous interview with Dr Martin Whitely, who’s written a book called Overprescribing Madness, outlining the mental health of our nation and why it perhaps some of the contributing factors to why it isn’t going as well as it might.
That’s even allowing for the current pandemic. I mean, this is a theme that I have been aware of for over 30 years, and that is a theme of looking at the role of the chemical, food, and pharmaceutical industry in all levels of health care.
Now, in the world of evidence-based medicine, we often hear this — trust the science, the science in medicine. Evidence-based medicine, these are all terms that we feel very warmly about and we as health practitioners embrace. It’s almost a religious expression that if you can preface whatever you’re saying by saying, “Oh, this is evidence-based, then everything else you say behind it after it is totally legitimate. All you have to do is acknowledge that it is evidence-based.”.
But actually, it’s not quite as straightforward as that. You know, it’s very difficult for busy practitioners to explore the influence of industry on guidelines and health care in general. People are just so busy doing what they’re doing that they haven’t got time to explore this.
I first came into this when I was fairly early on in my career when I was confronted with the idea that I shouldn’t be using mercury amalgam fillings. Of course, I defended it, saying, Well, this is what was taught at universities. All my professors said it’s perfectly safe. It’s locked in. There’s no problem with mercury amalgam fillings. That was in the early 80s.
I learnt that wasn’t the case and soon after that learnt that there was this famous quote from the dean of the Faculty of Medicine at Harvard congratulating the graduating year and said, “Congratulations on your graduation. I have some bad news and that is half of what we taught you is wrong, but unfortunately, we don’t know which half that is.”.
That is a sobering lesson for a health practitioner to learn and people may reject that because many health practitioners love certainty. We all love certainty, particularly when others are putting their health in our hands. But a certain level of curiosity is also important.
Scepticism is one thing, but curiosity is another and finding out where guidelines or how guidelines are formulated is worth doing. It’s a story that is very easy to miss but difficult to ignore because evidence-based medicine, it’s sometimes hard to tell the difference between evidence-based medicine and evidence-based marketing.
It’s worth mentioning that the gold standard of evidence-based medicine is the randomised, double-blind controlled study and the meta-analysis. These are the gold standards. A randomised, double-blind controlled study. Let me give you an example. Perhaps if we wanted to see whether parachutes really made a difference if you jumped out of a plane? Now I know this is an absurd example, but just to give you the example, if we had 20 volunteers and on 10 of the volunteers, we cut all the strings of the parachute, but we wrapped them all up exactly the same.
The crew didn’t know who was getting it, the pilot didn’t know who was getting it, and the people who were going to jump out of the plane. That actually would be a triple or double-blind controlled study. The crew didn’t know, the person didn’t know.
So that’s both groups are blinded to what they are actually doing and then all 20 people jump out of the plane and we carefully observe whether it in fact the parachute is whether there is evidence to support it. Or is this just anecdotal? Is it just anecdotal that putting a parachute on works?
Well, that study might be sobering to know next time you go up in a plane and are offered a parachute. You might be a little, you might find it sobering to learn that that study has never been done and so anecdotal evidence is all we have to go on. Take that for what it’s worth. It’s interesting because the randomised, double-blind controlled study is where the analysis of a given situation and the control of conditions occurs so that every relevant fact can be varied one at a time.
They are essential preconditions for scientific investigation, and that is a very good model when you’re looking at a pharmaceutical product and comparing it to a sugar pill, then you would want the randomised controlled trial to be the gold standard. When we start to get into the real world, that’s not quite as easy or straightforward or even relevant as it might seem.
In fact, as I mentioned, I’ve been following this for a long time, and I read a wonderful book by the Professor of Surgery at Sydney University, Founding Director of the Centre for Values Ethics and the Law in Medicine at the University of Sydney, Miles Little. This was a 1995 book.
He observed that human variation and the inability to achieve total control of variables make the criteria too stringent for most medical, particularly clinical research, so it’s relevant to us in the real world, particularly when you talk about nutrients, for example.
Now anybody that has studied undergraduate medicine — dentistry, health care — has studied biochemistry and knows that we need somewhere between 30, 40, or 50 elements. If you would test the importance of any one element, it would be an impossible undertaking which makes studying nutritional medicine challenging. But that’s not to say nutrition isn’t important, just as it’s important to wear a parachute if you’re up in a plane or at least have access to one.
There is a significant difference, I believe, between evidence-based medicine and evidence-based marketing because when we look at the science in medicine, we realise that up to 70% and I think this is the official figure, but I think it is much higher is actually funded by the pharmaceutical industry. This is worth mentioning too that the pharmaceutical industry is a private company in an enterprise, and it has a fiduciary duty.
In fact, its main fiduciary duty is to its shareholders so it is not to public health, it is to its shareholders. When the science in medicine is done by those that potentially have a conflict of interest, there’s a problem. This was alluded to in a 2005 article by Professor John Ioannidis.
Now it’s worth saying that John, Professor Ioannidis, and I would love to have him on as a podcast guest, put that on my wish list. He’s a professor of Medicine, Professor of Statistics at Stanford University in the School of Humanities and Sciences. What’s interesting about John Ioannidis is that when somebody does research how often their articles are cited by other researchers, there’s often an indication of just how relevant and important their comments are.
If you have done the research and you happen to be cited 100 times or a thousand times or even 10000 times, that would be quite amazing, extraordinary, and very, very impressive.
John Ioannidis has been, I think, cited 250000 times so this could be 251001. Anyway, in his article, Why Most Published Research Findings Are False, he outlined several things. The studies are too small, the effect on the sizes is smaller, but his main point is when there is a greater financial and other interest and prejudice.
Now, when the science in medicine is funded by the pharmaceutical industry that stands out as a red flag. He makes the point that simulations showed that for most study designs and settings, it is more likely for the research claim to be false than true. This is the science in medicine.
Now, if he was on his own, that would be one thing. As I said, I’ve been following this story for some time. Dr Marcia Angell was the former editor of the New England Journal of Medicine. She was that editor for two decades. The New England Journal of Medicine is one of the most prestigious medical journals in the world of medicine, and she wrote an editorial about the influence of drug companies on medical research.
In about 2003 and sadly was dismissed from her job or left her job soon after that, so she decided to write a book, and the title of the book gives you a little bit of a clue as to its contents. The Truth About the Drug Companies: How They Deceive Us and What To Do About It. Written in 2004.
Then another wonderful book in 2006 was written by Raymond Moynihan, Assistant Professor in NHMRC (National Health and Medical Research Council), Early Career Fellow of the Institute of Evidence-Based Health Care at Bond University in the Faculty of Health Sciences and Medicine. He wrote a book called, in 2006, Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients.
Now, on that note, I do discuss with Martin Whitely about the Diagnostic and Statistical Manual No. Five, edition number five, which came out about four or five or more years ago. I think it came out in 2013 or 14. It is 900 pages long. It outlines about 300 different mental health conditions.
In my own book, I asked the question when I talk about the DSM 5: Are we all mentally ill? Because if the DSM five is anything to go by. If you’re shy, no, you’re not. You have social anxiety disorders. If you feel better in summer than in winter, then you have seasonal affective disorders. If you are one of those people that grieve for more than a month or so, for somebody who lost, you lost close to you. Well, there’s a mental health condition there as well.
That was the 2006 book and then was senior lecturer, physician and epidemiologist and lecturer in public policy at the Harvard Medical School. You can kind of get a feel for the fact that these aren’t social media influencers.
These are people in the thick of things and mainly in public health and he wrote a book. This is John Abramson called Overdosed America: The Broken Promise of American Medicine. It’s interesting to note that in America, 5% of the world’s population in America consumes 50% of the world’s psychotropic drugs, prescription drugs. So there’s a sobering thought and they’re not enjoying good health as a result of it. I digress for a moment.
Now as I pursue this further, and I’m just sharing with you a journey that I’m mentioning books that I encourage you to have a look at, particularly if you’re a health practitioner. This was a particularly powerful one by British Epidemiologist and researcher, Ben Goldacre. Many of us are now familiar with what epidemiologists do, but anyway, he wrote a book called Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, 2012.
Now there’s an organisation that was formed to try to address this. It’s called the Cochrane Collaboration to try to address the fact that there is an undue influence of drug companies on medical, on health care. At all levels of health care. From education right through to government policies, regulations right to the doctor’s surgery.
Back to Ben Goldacre, he tried to address this with a new initiative called the Old Trials Register, which is trying to suggest that all drug company trials should be registered. You see, when a drug company does say they did 10 trials on drugs and eight of them were negative and two of them were positive.
Well, as Ben Goldacre couple points out, they’re not compelled to publish the eight negative ones. In fact, they would only they often have only published the positive ones, and it’s even more insidious than that. You really need to go into details. But he formulated The Old Trials campaign.
Now, the Cochrane collaboration was actually founded in 1993 by Iain Chalmers, David Sackett, and 70 other international colleagues. The goal of the Cochrane Collaboration is to create and disseminate up to date reviews of and here it is again randomised control of health care interventions in order to help health care professionals make informed decisions. That is the Cochrane Collaboration in 1993.
Now, 20 years later, one of those 70, Professor Peter Gøtzsche, wrote a book and it was entitled, and again, the title certainly gives away quite a bit here. Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Health Care. Written in 2013, 20 years after the Cochrane Collaboration. Written by one of the founders of the Cochrane Collaboration. Quite sobering and again, not a social media influencer, just a researcher. In the book is a rather disturbing list of fines that are given out to the pharmaceutical industry.
In fact, the top 20 largest pharmaceutical company settlements between 1991 and 2010 are listed and one of the biggest pharmaceutical companies is GlaxoSmithKline. They hold the record in 2006 for $3.4 billion of fines.
Interestingly, Pfizer, many of us have heard the Pfizer name, a $2.3 billion fine in 2009 for unlawful promotion and kickbacks. There are others here as I work my way down. AstraZeneca $520 million in 2010 for unlawful promotion and kickbacks. They actually had a fine in 2003 as well.
AstraZeneca rather trifling minor $355 million. Pfizer, incidentally, had another one in 2004 for unlawful promotion, $430 million, so this is a rather sobering thing. And many of those names are now household names and again, this is not something new. This is something Harvard University has explored in its Centre for Ethics.
In 2013, I was looking at an article called Institutional Corruption of Pharmaceuticals, and wait for it, the Myth of Safe and Effective Drugs. 2013. We’re almost up to now, 2016, and we’re back to John Ioannidis, who was reflecting some 10 or 11 years after his last. Well, he’s published plenty.
There was a study, a comment that he made in the Journal of Clinical Epidemiology in 2016: Evidence-based medicine has been hijacked. A report to David Sackett, who is one of the founders of the Cochrane Collaboration. Meta-analysis and guidelines have become a factory. This is what John Ioannidis says, Professor John Ioannidis, “Meta-analysis and guidelines have become a factory, mostly also serving vested interests. National and federal research funds are funnelled almost exclusively to research with little relevance to health outcomes.”.
We then fast forward to 2019 and in 2019, The Corrupting Influence of Purdue and the World Health Organisation. The World Health Organisation is intended to be stewards of the public interest, but allowing Purdue, who were the manufacturers of OxyContin and the Opioid industry to influence guidelines on how opioids should be prescribed and regulated.
The WHO has violated that trust. The agency owes the public an explanation, and it’s sobering to learn that the opioid epidemic when Purdue again held back a lot of important research there, cost 400000 lives. 400000 lives.
Which brings us to this week’s podcast, which was with Martin Whitely, who wrote this amazing book called Overprescribing Madness: What’s Driving Australia’s Mental Health Epidemic? It’s a very sobering read. I wish I could say it was an enjoyable read. It’s not, but it’s an incredibly well-referenced read.
If you are serious about wanting to follow this through, I would recommend you read it online on an electronic device because, Martin, the last 60 pages of this book, has 573 references and they are all hyperlinked. He has done his Ph.D. on this kind of story, particularly referencing ADHD, which he talks a lot about.
Now I’m going to pull out this one quote from the book, which is quite disturbing and I think sobering, particularly in our current environment but I’ll leave that thought with you. “Bearing Ingelheim, which is another drug company, ended up settling the Pradaxa lawsuits in 2014 for 650 million US dollars.”
Now, again, Pradaxa. What is Pradaxa? Pradaxa is an anticoagulant drug, and what the company forgot to mention in their research, which they cherry-picked out, was that whoever gets prescribed this drug should really have blood tests done first, and certain elements should be eliminated.
You know, they shouldn’t give it to some people. They didn’t put that in. As a result of that, 60000 people died and they settled out of court for that. Enormous fines and settlement payments like that for Pradaxa.
This is Martin’s, and I’m quoting from Martin’s book here, “Seemed to be accepted as just part of the cost of doing business for many of the world’s largest pharmaceutical companies.” Now here is a sobering statistic, “From 2004 to 2013 in the USA, at least almost $20 billion US in fines and settlements were paid for off-label promotion and marketing, and fraudulent, misbranding and marketing.
Companies fined included Johnson and Johnson. Johnson and Johnson also made the mesh that they had a huge settlement out. You know, this is the mesh where the women were encouraged to use in the pelvic floor following birth. They were also the makers of the Janssen vaccine.
GlaxoKlineSmith (sic) [Correction: GlaxoSmithKline], now they’ve come up with a new treatment called Sotrovimab for COVID-19, by the way, and it has received TGA approval. It costs about $2000 for an 8ml vial. It is said to reduce time in hospital or reduce the symptoms of COVID, so it is received approval.
Interestingly, Vitamin D, which is impacts every single cell in the body and has a profound impact on your immune function. The TGA doesn’t feel there’s enough evidence to support that, but it has approved GlaxoKlineSmith (sic) [Correction: GlaxoSmithKline]. I digress there for a moment. I was listing out those companies that had received almost $20 billion of fines over a 10 year period in America. Johnson and Johnson, GlaxoSmithKline, Abbott, and Novartis, Forrest, AstraZeneca, Pfizer, Eli Lilly, Bristol-Myers, Squibb, and Purdue, the makers of OxyContin.
The latest high-profile drug scandal that Australians are yet to fully comprehend is the misuse of pharmaceutical opioids like OxyContin in the USA. The opioid crisis has claimed a staggering 400000 lives over the past two decades. This scandal has received enough publicity to sound warning bells.
However, there is little evidence of an appropriate response so far. I love the way the TGA is very reluctant to embrace, embrace nutraceuticals like vitamins that are totally safe and needed for every cell in the body but are very quick to embrace the pharmaceutical world. Look, once we get started on this topic, we could go on for quite some time.
But I want to leave you with this, and this is the Hippocratic Oath above all to no harm. This is why we have focussed so much in this podcast on improving immune function, and we will continue to do that. I’m not against any of them, I think there are some great pharmaceutical products out there and the vaccines are a part of that, that’s for sure.
If public health is what we are truly all about, then I think we should be looking at public health and everything that is positive about public health and not approach the science in medicine as friends. What we do not need are friends of science in medicine. What we need are scrutineers of the science of medicine. That is what is critically important.
I hope this podcast and some of those books that alert us to that fact remind you of that. This is a story. As I’ve said, it’s very easy to miss, but once you hear it very difficult to ignore, I’d encourage you to have a listen to this week’s podcast. Read some of those books. Until then, I hope this finds you well. Be well.
This podcast provides general information and discussion about medicine, health, and related subjects. The content is not intended and should not be construed as medical advice or as a substitute for care by a qualified medical practitioner. If you or any other person has a medical concern, he or she should consult with an appropriately qualified medical practitioner. Guests who speak in this podcast express their own opinions, experiences, and conclusions.