Prescription Drugs: Getting Away With Murder

by Research Insights0 comments

Share this page:

It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry ….’

Peter Rost, former VP Marketing, Pfizer

Main Points

  • Most pharma companies have noble goals, mission statements and visions;
  • The biggest fines in pharma history have been imposed on household name companies;
  • Some say the industry has more in common with organised crime than patient welfare;
  • These days, pharma dollars reach into government, regulators, charities, research and further;
  • When fraud, malpractice or death are proven, the drug regulator’s only weapon is penalty.

(A related concern is that some drugs commonly prescribed to boomers dramatically increase our risk of Dementia. If you value your brain and want to protect it against Dementia, check out our guide: Dementia: Keep Your Marbles. It reveals the true causes of Dementia and what you can do to prevent or even reverse it.)

Inside Job

The quote at the top is from someone who used to work inside Big Pharma, not a reporter from outside. It was more direct than I expected, but there are many more like this, from others inside.

By the way, if you’re of the view that ‘the pharmaceutical industry is a noble one and anyone who says otherwise is a Conspiracy Theory nut case’, please stop reading now. You won’t like reading the facts one bit.

This post is quite long, but to get the gist of it, take a few moments to read this short post. It’s about Glaxo Smith Kline (GSK), one of the world’s biggest drug companies.

In 2012, it was found guilty of very serious crimes: bribing doctors to prescribe antidepressants licensed only for adults to children, failing to share vital safety data about this and other drugs with the FDA, covering up the fact that its blockbuster diabetes drug increased the risk of heart disease, paying experts to speak at meetings to other doctors about positive research on their drugs’ unapproved uses, and handing out false papers claiming positive results in clinical trials that had negative ones.

It doesn’t get much more serious than these, yet they came to light in the same year that GSK’s CEO Andrew Witty received a knighthood. Not for producing breakthrough drugs that saved lives, mind you, but for making a major contribution to the British economy. Below you’ll see how flouting the rules might have helped with this.

‘Biggest fine in the history of the drug industry’

GSK was fined one billion US dollars as a result of a ‘Criminal Plea Agreement’. In addition, it was fined US $2 billion for a long list of serious misdemeanors.

GSK forgot to mention the criminal plea agreement in the statement it issued, which said only that it would plead guilty to some ‘misdemeanor violations’. It added that it would pay the $3 billion fine out of ‘existing cash resources’. GSK ended up pleading guilty as this Press Release from the US Department of Justice shows.

Three billion dollars sounds like a huge fine but, according to its 2012 Annual Report, GSK made a net profit of US$10 billion anyway. Clearly shareholders were expecting worse, because its stock value rose when the ‘biggest fine in the history of the drug industry’ hit the news. More dumbfounding is that GSK was allowed to go on selling the 10 drugs in question, some of which had caused suicides, holes in the hearts of newborns, heart attacks in adults and more.  

The stock’s rise reinforces the idea that criminal fines for giant drug companies, no matter how big, are less a deterrent than a cost of doing business.

‘The Terrible Things GlaxoSmithKline Did Wrong’, Matthew Herper, Forbes, 2012

Why weren’t GSK’s executives charged for their crimes, and locked up?

Why did the company not lose its licence to sell drugs? It had clearly shown that it put profit before safety, including for children, not once but many times over many years. We will never know how many lives these drugs damaged or extinguished.

Raw Power

The answer is that the drug industry has a lot in common with the mafia. It wields the same power, uses it with the same brutality, and amasses unimaginable fortunes. Yes, this is a tough subject for us boomers. We consume more prescription drugs than any other age group under 75.

Are we naïve to think that the drug industry should be working for our benefit? Are we gullible in our belief that doctors do that too, based on solid information gained from independent research and rigorous clinical trials?

We boomers have always been reluctant to trust authority, and we’ve had ample reason for this. We took to the streets to protest against wars in faraway places but this war is taking place in our backyard. Some of these prescription drugs are far more dangerous than the weed we used to smoke.

Over the past two decades, the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession.’

Dr Marcia Angell, former editor, New England Journal of Medicine

How is this happening? Because regulators are asleep at the wheel, governments are out of their depth or don’t care, and drug makers deceive doctors with spin dressed up as science.

Drug companies have changed dramatically in our lifetimes, as the lament above from former editor of the NEJM Marcia Angell makes clear. Not only are they breaking the rules, they’re hijacking the very peer-reviewed journals that we mere mortals rely on for the facts.

Game Over

You’d think a statement like Angell’s would cause drug makers to protest their innocence, regulators to announce tougher sanctions, governments to launch in-depth enquiries, and medicine to wonder if it had made a pact with the devil.

None of that happened. When Angell realized that her blunt revelations had no impact, she resigned from the world’s foremost medical journal. Her last warning made her position crystal clear.

It is simply no longer possible to believe much of the clinical research that is published.’

Dr Marcia Angell, former editor, New England Journal of Medicine

By the turn of the millennium, big pharma had become the main sponsor of medical research. In other words, it owned most of the medical research being carried out in the western world.  If researchers and leaders of clinical trials wanted to survive professionally, they had to fall in line and learn to live with multiple conflicts of interest.

The Diseases of Civilisation

The rapid growth in the diseases of civilization over the last five decades – heart disease, diabetes, cancer, obesity, depression and dementia – promised vast fortunes to companies that produced effective drugs.

Since these are mostly lifestyle diseases, drugs aren’t very effective, so the drug makers put their marketing gurus in the driver’s seat, with clear instructions to make dubious drugs look good and find new markets for their wares. They also co-opted medical thought leaders to help persuade doctors to prescribe these drugs in large numbers.

Let’s see how this works, using a couple of boomer conditions and GSK as cases in hand. According to the BBC, GSK admitted to promoting antidepressants Paxil and Wellbutrin to doctors for unapproved uses, including the treatment of children and adolescents. GSK also admitted that it had held back data and made unsupported safety claims over its diabetes drug Avandia.

GSK had marketed these drugs over a number of years in blatant disregard of FDA regulations, and had paid doctors to write millions of off-label prescriptions. The more prescriptions doctors issued, the bigger the kickbacks from GSK. The Guardian lists all the sordid details of GSK’s lavish promotions. 

The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets for Madonna concerts.’

US Attorney General, Carmin Ortiz

Until then, Pfizer held the record for paying the biggest fine – US $2.3 billion in 2009 for off-label or unapproved promotion of medical products. $1.3 billion was for criminal conduct. The GSK fine was 30% higher.

Massive Fine or Massive Failure?

The scandal broke only after four ex-employees of GSK became whistleblowers.

The  FDA was sound asleep while GSK and its supplicant doctors were shamelessly breaking the law. This was despite consistent reports in the media, going all the way back to a 2002 BBC Panorama program that focused on Paxil’s role in high numbers of youth suicides.

Paxil is an SSRI (Selective Serotonin Re-uptake Inhibitor), a drug class that now carries FDA black box warnings for an increased risk of suicidal thoughts and behaviors in children and adolescents, age groups where depression is sadly quite prevalent.

By July 2010, GSK had settled approximately 800 Paxil birth defect lawsuits at a cost of $1.14 billion, with an average payout of $1.2 million to families of affected children.’

Drugwatch.com

I doubt that even the mob would bribe doctors to prescribe a drug to children as an off-label treatment for depression and anxiety, knowing that it would destroy young lives. GSK supported its positive claims with medical journal articles that misreported data from a clinical trial.

In 2005, the FDA informed doctors that Paxil could cause heart defects in babies if taken by pregnant women during the first trimester. It asked GSK to update the pregnancy warning on Paxil’s label. That was it. As you can see from the above quote, at least 800 claimants were affected; who know how many more didn’t get involved but suffered anyway.

To improve the quality of human life by enabling people to do more, feel better and live longer.’

Company Mission Statement, Glaxo Smith Kline

A noble ambition which belied GSK’s actions over years.

Corporate Integrity?

GSK also signed a five-year Corporate Integrity Agreement (CIA) with the US Department of Health, which required it to change its behaviour and report for 5 years to an independent monitor appointed by the US government.

If you thought other drug makers might have changed their ways after the GSK scandal, you’d be wrong.

In 2013, Johnson & Johnson (J&J) was fined US $2.2 billion for promoting Risperdal, Invega and Natrecor for uses not approved as safe & effective by the FDA, for targeting dementia patients in nursing homes, and for paying kickbacks to physicians. In 2021 J&J was fined US$5 billion for unapproved and off-label promotion of medical products. In a separate action in the same year, the company was fined US $2.5 billion for product safety violations. Small change compared to its annual profit of nearly US$25 billion that year.

In 2015 drug maker Takeda settled some 9,000 lawsuits that accused the company of failing to warn users of its diabetes drug Actos of the risks of bladder cancer, heart failure and other adverse effects. According to drugwatch.com, ‘the majority of the lawsuits claimed Takeda and Eli Lilly, the drug’s marketer, knew about the risk of bladder cancer and other side effects but did not warn the public.’

The pharmaceutical industry is unique in that all large firms explicitly state that they are focused on promoting patient welfare, yet the majority engage in illegal activities that harm patient welfare.

Professor Denis G. Arnold, University of North Carolina, Charlotte

Purdue Pharma was fined over $8 billion for fraud in 2020, for marketing opioids (oxycodone) as non-addictive. It’s estimated that these painkillers have ended the lives of some 400,000 Americans prematurely over the last 2 decades.

Racketeering

So drug company behaviour hasn’t improved, despite the fines growing ever bigger.

Professor Denis G. Arnold is a coauthor of a study of drug company behaviour between 2003 and 2016. His quote above shows just how hollow company statements about patient welfare are; patients don’t seem to even be in the picture, aside from being necessary to buy the drugs.

Arnold adds that the industry has the worst reputation of any industry in the US, according to Gallup polling. Yet, the drug industry enjoys privileged status that protects its executives from being punished for their actions. Only one man called their behaviour for what it sees to be: ‘racketeering’.

Peter Gøtzsche is a co-founder of the prestigious Cochrane Foundation for evidence-based medicine, and a physician and medical researcher who has worked in, and commented on, the pharmaceutical industry for many years.

He has published over 50 articles in major medical journals, and these have been cited thousands of times. Gøtzsche is also the author of a book called Deadly Medicines and Organised Crime: How Big Pharma has Corrupted Healthcare. In it, he quotes Peter Rost, a former Pfizer Vice President of marketing at Pfizer. (Part of the quote is at the start of this post. Below is the full enchilada.)

It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry…. The difference is, all these people in the drug industry look upon themselves … as law-abiding citizens, not as citizens who would ever rob a bank …. ‘

However, when they get together as a group and manage these corporations, something seems to happen … to otherwise good citizens when they are part of a corporation. It’s almost like when you have war atrocities; people do things they don’t think they’re capable of.’

Peter Rost, former VP Marketing, Pfizer.

Organised Crime or Business as Usual?

Gøtzsche went far further in more detail in his book. Needless to say, not everyone agreed, seemingly taking more issue with the the correctness of likening the pharma industry to ‘an organised crime entity’ rather than the thrust of the whole book.

This is how reviewer Justin B. Biddle put it:

(The book) is flawed in its treatment of “big pharma” as an organized monolith. “Big pharma” is not an organized entity but rather a collection of corporations, and as such, “big pharma” could not be considered an organized criminal enterprise.’

Justin B. Biddle

Well, that’s a relief.

Then Gøtzsche reminded everyone that Hoffman-La-Roche executives had led a cartel that, according to the US Justice Department’s antitrust division, ‘was the most pervasive and harmful criminal antitrust conspiracy ever uncovered.’ Top executives at some of the world’s biggest drug companies met secretly in hotel suites and at conferences to fix prices for bulk vitamins.

They worked together in a coalition they called ‘Vitamins Inc.’, carving up world markets and increasing profits with carefully orchestrated price increases. How was this not ‘an organized criminal enterprise’?

Eight companies were fined 855 million Euros in 2001 for what the EU antitrust chief, Mario Monti, described as the ‘most damaging series of cartels the commission has ever investigated.

Hoffmann-La Roche, BASF, Aventis, Solvay Pharmaceuticals, Merck (Germany) as well as 3 Japanese companies were fined, but the fines were halved after the companies agreed to cooperate with the EU’s investigation.

Big Pharma and the UK government

In March, 2005, the UK House of Commons Health Select Committee reported on the influence of the pharmaceutical industry.  According to The Lancet, ‘its overall findings were clear: the influence of the pharmaceutical industry is enormous and out of control.’

No surprise there, but what was new was a major shift in the pharmas’ targeting. See the quote in full below.

‘ … today big pharma’s tentacles penetrate much more widely than the traditional health professionals, reaching ‘patients, health departments, regulators, managers, researchers, and medical charities, and then on to academics, the media, carers, school children, and politicians. ‘

Comment, The Lancet, January 14, 2006

The British Medical Journal published a similar piece under the heading of ‘the influence of big pharma.’ It says that ‘over half of all postgraduate medical education in the UK, and much education of nurses, is funded by the pharmaceutical industry from its annual marketing budget.’

The British drug industry’s stated goal is ‘to bring patients life-enhancing medicines,’ a goal ‘not only necessary but noble.’ There you go; there is is: the noble pharma industry position. These guys have thicker hides than rhinos (or as one Aussie mate of mine used to say ‘More side than a rat with gold tooth‘.) Hardly surprising, the UK government ignored most of the recommendations of the House of Commons Committee and did nothing.

Governments roll over

There’s one constant in the story of big pharma: whatever crimes it is accused of, however many people die from its drugs, and whatever fines it has to pay to make up for its crimes, it remains untouched. The industry is about as indestructible as the Blue Brothers in their eponymous film. (Remember how, after Carrie Fischer blows up the Chicago guest house they’re in, they climb out from under the rubble, brush the dust off their black suits and walk away?)

Governments don’t like to interfere. If they look like they might, big pharma’s army of lobbyists in Washington goes to work warning congressmen about massive job losses. According to Open Secrets, drug companies have 1,700 lobbyists in the capital who spend $350 million doing their jobs. That’s twice as much as any other industry.

Governments make rewarding targets for Big Pharma, as we saw with the Tamiflu saga. Governments around the world spent billions stockpiling a dubious drug that Roche claimed prevented the spread of the H1N1 (swine) flu, and reduced serious consequences for those who were infected.

They paid billions despite Roche refusing to release their trial data. The British Medical Journal ran a four-year campaign to shame Roche into releasing the data. When the drug maker finally gave in, The Cochrane Collaboration (for evidence-based medicine) found that most of the claims made by Roche were false. The only benefit was that it shortened the duration of influenza symptoms by half a day.

Adverse events included psychiatric disturbances, renal problems, nausea, vomiting and headaches. There was no evidence of Roche’s claims that Tamiflu reduced the risk of secondary complications such as pneumonia. Check the full story here.

Footnote

What I uncovered shocked even me.

I expected to find quite a few misdemeanours and bendings-of-rules. I wasn’t prepared for a tsumani of evidence of serious offences against myriad pharma companies spanning the US, UK, Asia and Europe. This isn’t some sort of beat-up on the industry; it’s a sorry tale which I doubt will have a happy ending. Governments are not equipped with the right weapons to tackle insidious crime of this magnitude and maybe lack the will to even try.

Sadly, this is just the tip of an ugly iceberg. You can find out more in our blog post The 10 Drugs Boomers Should Not Take.

Get Updates

LIKE TO STAY RIGHT UP TO DATE?

Get free updates to your inbox

Kim Brebach

Kim Brebach

Hi, I’m Kim Brebach, boomer, information researcher, technical writer and Joiner of Dots at M&M. In my spare time, I review wines and love to cook.

[]
×
Like an EXTRA 5% OFF?

Claim your discount now

No thanks. I'm happy to pay the offered price. *You can unsubscribe at any time.