It directly employs 4.4 million people worldwide and generates $1000 billion in revenue. Every year, it’s responsible for dozens of new drugs being approved for public use – the US Federal Drug Administration approved 60 in 2018. And it’s said to invest around $4 billion annually in research into new medicines.
The pharmaceutical industry is a very big deal indeed.
But there are serious questions to be asked and answered about the integrity of that research – questions about who is really served by the drugs that are allowed to come to market, and about the lack of rigour in the approvals process.
Dr Peter Gotzsche, the former leader of the highly respected Nordic Cochrane Centre in Copenhagen, says evidence he’s collected over a period of years reveals behavioural patterns within Big Pharma that amount to a widely accepted definition of organised crime that results in thousands of unnecessary deaths every year.
His book, Deadly Medicines and Organised Crime, is an evidential study of a conspiracy so intricate that you’d be forgiven for thinking it’s the stuff of a far-fetched novel.
In it, he talks of collusion and corruption that infects the most senior levels of world medicine – from senior doctors to Government ministers. He points to evidence of key influencers in the approvals chain being bought by pharma companies whose vested interests in their drugs making it to market amounts to many millions of dollars.
More shockingly, his evidence suggests that many thousands of people are dying as a result of Big Pharma drug research that goes nowhere near far enough in satisfying even the most lenient of safety criteria.
In an extended interview on the subject, he says his evidence proves that pharmacology is the third biggest killer in the world behind heart disease and cancer. 200,000 people died in the United States in 2015 as a result of bad pharmacy prescribed by their GP or consultant.
Around half died as a direct result of side effects of the medication they were given. The other half died because of a mistake made by physician (usually a case of the drug being unsuitable for that individual for whatever reason).
Dr Gotzsche is an eminent and respected figure in evidence-based healthcare. He co-founded the Cochrane Centre as an independent charity tasked with helping doctors and individuals to make healthcare decisions based on researched fact, rather than the hyperbole of the pharmaceutical industry.
Given his personal credentials and the credentials of the organisation he founded and led, even a cynic would have to agree that his research into the conspiracy that supports pharmaceutical approvals is worthy of further scrutiny.
If we take Dr Gotzsche’s evidence at face value – and he’s a long way from being a lone voice speaking out against the Big Pharma machine – then what conclusions can we draw from it?
The key takeaway must be that if large pharmaceutical companies need to lobby influencers and decision-makers (at the less sinister end of the scale) or buy them off (at the most sinister end), then there is something fundamentally wrong with the way those companies try to prove the case for their products.
We need to ask whether the research was rigorous. We need to ask whether the controls were rigorous, if the data tests were rigorous. In short, we need to be convinced that the company has gone to lengths to prove their drug is unsafe – which, after all, should be the benchmark of any rigorous process in this context.
Because if they’ve done that, and the drug still comes up safe, then there is no need buy Government approval by other means.
Conclusion 1, then, is that current pharma-sponsored drug research lacks the required integrity and independent oversight to allow us to have complete confidence in it.
If Conclusion 1 is also Truth 1, then what is the next conclusion to be drawn from the shady operations that Dr Gotzsche alleges are behind many new drugs that come to market?
The only one would seem to be that the drug companies know their research is flawed and that their products come with risks as a result.
Do they willingly market drugs they know are likely to kill? You’d hope not, and the companies would argue, with some degree of justification, that most, if not all, drugs come with some degree of risk.
In this context, though, it’s not the risk that’s the issue. It’s the simple fact that the drug companies are not doing the right amount of work to mitigate and reduce that risk to make their products as safe as possible.
It takes many years and a great deal of money to develop a new drug. The cost of failure runs to hundreds of millions of dollars. It doesn’t take a blind leap of faith to believe the big pharmaceutical companies will do whatever necessary to get their latest drug over the line – even if it means playing fast and loose with the law.
Conclusion 2, then, is that a lack of rigour in the approvals process is pushing substandard products into the marketplace
And where, then, does that leave those of us who are pioneering new, complementary and alternative treatments?
Inevitably, it makes us an uncomfortable truth for the pharmaceutical industry that it is eager to dispel.
In spite of the overwhelming evidence that exists to show the products and techniques we use have demonstrable benefit as an adjunct to, if not a direct replacement for, conventional treatment, the health sector is unwilling in the extreme to even consider how that benefit might be harnessed and utilised to achieve better health outcomes.
Conventional medicine generates profit for pharma and funding for healthcare and charities. It’s easy to see why no-one in mainstream healthcare is interested in looking too deeply at the existing research that supports complementary care, or to seek their own truths.
And through all of that, the people who really suffer are patients who are ill-served by what they take in good faith, who rarely find out that other choices are available to them and whose health may be compromised by following the simple but ill-informed advice of someone they trust to put their health interests first.
Conclusion 3, then, is that poor research practice that results in bad pharmacy will continue to dominate and dog the health sector until some form of effective independent oversight is put in place to regulate it.