The formula for creating best-selling drugs

Williamson is a small town in West Virginia with a population of just 2,800 people, which would deserve barely a mention in the history books but for one extraordinary claim: it is the heart of the opioid epidemic that has destroyed whole communities across the US. Two pharmacies in the town have churned out 21 million pills, earning it the nickname ‘Pilliamson.’

The effects of this pill-popping have been devastating. The US government estimates that opioid addiction has cost the nation $1 trillion in lost output, while economists estimate that it accounts for a 20 percent decline in male participation in the labor force – in other words, one in every five men is unable to work as a direct result of being an opioid addict. West Virginia has been the worst-hit state – especially communities close to Williamson. In neighboring Huntington, 10 percent of babies are born with opioid withdrawal symptoms.

Yet, with all the regulatory safeguards in place, how could the opioid epidemic have started, let alone escalate to the level it’s now reached? Researcher Chris McGreal has identified four key factors that meshed together like interlocking cogs to make the nightmare possible.

In his book American Overdose (Public Affairs, 2018), he describes how it started with drug companies such as Purdue Pharma, manufacturer of the opioid best-seller Oxycontin (oxycodone), claiming there was an epidemic of chronic pain that could be treated with nonaddictive, long-term opioids.

These dubious ‘facts’ needed scientific verification, so researchers and academics were brought in to ‘prove’ that the claims were, indeed, the case through a series of medical trials and studies. Once the science was in place, regulators like the US Food and Drug Administration (FDA) were more than happy to accept it at face value and approve a range of opioids as safe, nonaddictive and effective.

Finally, with all those lights turning green, doctors had few qualms about prescribing the opioids, and any misgivings were assuaged with cash rewards and other incentives, such as computer equipment and vacations masquerading as important conferences, with all expenses footed by the drug company.

This sequence of events is not unique to opioids. It is the blueprint for many drug launches, rolled out by Big Pharma with each new offering to convince everyone – including the patient – that their products are needed.

Stage One: Invent the problem

The drug companies’ first move was to claim there was an epidemic of chronic pain that could be successfully, and safely, treated with opioid painkillers.

It’s a tactic that’s been called malady mongering or condition branding, where the extent of a disease is exaggerated – or even made-up – to help sell a drug that’s either already on the shelves or in the planning stage.

A cornerstone of the tactic is organizing continuing medical education (CME) courses that help “establish a disease state in the minds of clinicians,” so that they are immediately receptive when a solution is produced. Researchers from the University of California at San Diego focused on one supposed condition – hypoactive sexual desire disorder in women – that had been the subject of 14 free (and industry-funded) CME courses ahead of the launch of a drug solution called Addyi (flibanserin).1

The courses emphasized that the problem is both common and underdiagnosed, and while women may not even be aware they have it, doctors can easily diagnose it from a simple questionnaire. They readied the market for the drug, which was heralded as a solution for low female sexual desire – but, as the researchers state, the problem doesn’t exist. “There is no scientifically established norm for sexual activity, feelings or desire, and there is no evidence that hypoactive sexual desire disorder is a medical condition,” they conclude.

Men are not immune. Apparently, they can suffer from low testosterone or ‘low T’ – but, fortunately, the drug industry has a solution. Increasing testosterone levels reduces the risk of heart disease and improves sexual function, muscle weakness, mood and cognition, the drug industry claims – but there’s no evidence it actually makes any difference.

Researchers led by Adriane Fugh-Berman from Georgetown University looked at 156 controlled trials – which explored the effects of a low testosterone level as well as the benefits of supplements against a placebo product – and found the problem didn’t exist. As a result, the supplements and drugs were a waste of time and money.2

“Marketing for drugs can start seven to 10 years before they go on the market. Because it’s illegal to promote a drug before it goes on the market, what they’re promoting is the disease,” she said.

Psychiatric disorders provide a rich harvest for the drug industry. According to the DSM-5, psychiatry’s ‘bible’ of all mental problems requiring drug treatment, people who are loathe to throw things away may be suffering from ‘Hoarding Disorder’ while unruly children could be victims of ‘Disruptive Mood Dysregulation Disorder.’ When the DSM was first published in 1952, it listed 14 disorders that could be treated with drugs; in the latest edition, published in 2013, there are 250.

Stage Two: Prove it

Having established in everyone’s minds that a fictitious disease actually exists, proving that there’s a remedy out there to treat it is relatively easy.

While serving as editor of the New England Journal of Medicine, Dr Marcia Angell estimated that up to 70 percent of medical trials were fraudulent. She later wrote: “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.” 3

Since most clinical trials are paid for by the drug company whose product is being assessed, it’s perhaps not surprising that the results are always positive. One review of 56 studies of arthritis drugs – all paid for by the manufacturers of the drugs under investigation – noted that every single one came to a favorable conclusion.4

A separate review estimated that studies funded by a drug company were four times more likely to produce a favorable result. Dr Richard Smith, a former editor of the British Medical Journal, commented: “The evidence is strong the drug companies are getting the results they want.”5

Drug companies often employ marketing companies to provide a positive spin on research data – and it’s an arrangement that suits everyone (aside fr
om the patient, of course).

Drug companies get the glowing review they need to convince regulators and doctors, and medical publications may earn up to half their revenues by reprinting the studies for their drug company sponsors to circulate among prescribing doctors.6 Just a single drug study can net the publishing journal $1 million in reprint sales, according to former BMJ editor Richard Smith. 7

Stage Three: Get approval

Once there’s a body of evidence to show a drug is safe and effective, it’s not surprising that regulators such as the FDA would give their approval for use on the open market. But there’s a sinister side to the story.

The FDA relies on its advisory committees – made up of experts in their fields – to recommend a drug’s approval. Most committee members have close ties to the drug industry, which immediately throws into question their independence, but they also get financial kickbacks if they get the drug through the approval process.

An investigation by the journal Science discovered that committee members were receiving sums from drug companies in the range of $1,000 to $10,000, all the way up to $1 million. Special ‘thank yous’ also took the form of hotel and flight reimbursements, consulting fees and funding to conduct further research. “You do something for a company that you feel confident is going to pay you back for it later on, and they do,” said medical ethicist Carl Elliott at the University of Minnesota.8

Perhaps the most shocking aspect of the process is that the FDA is aware of these kickbacks, but doesn’t consider them to be unethical and doesn’t ask about any financial rewards after an approval has been recommended.

Stage Four: Getting it prescribed

The ‘evidence’ may be there, the drug may have been approved, but doctors can sometimes need a little helping hand before they prescribe it.

The independent journalism nonprofit ProPublica estimates that drug companies paid out around $9.15 billion to US doctors between 2013 and 2016 for prescribing their drugs and using their equipment. The highest paid, an orthopedic surgeon, was handed $65.3 million during that time, while a doctor in internal medicine received 3,623 separate payments.9

The practice of bribes-for-prescriptions isn’t unique to the US. In Britain, drug companies paid £116 million ($150 million) to doctors in one year as an incentive for prescribing their drugs, with individual doctors earning around £100,000 ($130,000) from the scheme, a registry called Disclosure UK has revealed.

Drug companies paid out an average of £4 million ($5.2 million) in incentives, as part of their marketing costs. Drug marketing budgets outpace research and development costs by a factor of 19 to 1.

Sensitive to the public backlash over opioid overprescribing, drug companies have been cutting back on the cash incentives being paid to doctors, but that hasn’t always been the case, as a CNN-Harvard University analysis has discovered. Between 2014 and 2015, hundreds of doctors across the US were receiving six-figure rewards for prescribing opioids, and thousands more were paid at least $25,000 for their efforts.

The most worrying trend seen by the researchers was that the more doctors prescribed opioids, the more they were being rewarded. “I don’t know if the money is causing the prescribing or the prescribing led to the money, but in either case, it’s potentially a vicious cycle,” said researcher Dr Michael Barnett from the Harvard T H Chan School of Public Health.10

The last word goes to Willis Duncan, who was interviewed by Chris McGreal as part of his opioid research. Despite losing his son and wife to opioid addiction, Willis admitted he was still unable to break the habit for many years, and told McGreal: “They all worked together: the doctors, the pharmacies. They didn’t give a rat’s f***.”

And that’s the real bottom line. It’s about a betrayal of trust, and putting money and gain above people’s lives.

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