This is a (totally fictional) story about a man called John. John lived in a house with a hedge, but he had recently gotten himself a pet dog. Unfortunately for John hedges aren’t very effective at keeping dogs from getting loose and running around the neighbourhood. John being the enterprising man that he is called a company that manufactures fences and asked if they had any fences suitable for keeping his dog on the property.
“Yes, we can definitely help you out with that sir. Our decorative deluxe model of fence is perfect for keeping dogs on the property.” The salesman told John.
“Great, I’ll take it!” John replied and after arranging the payment a worker dutifully arrived at his house the following day to install his new fence. Unfortunately, John’s fence was not as effective at keeping the dog in as he had hoped. Not only did the fence have gaps the dog could fit through, the gaps were suspiciously dog shaped, complete with ear shapes so the little tearaway wouldn’t have to rub them on his way through.
John called the fence company back to complain. “Why did you tell me this fence would keep dogs in? Not only does it not keep dogs in, it seems specifically designed to let them out!” he said. The salesman reluctantly informed John that the fence hadn’t really been designed with keeping dogs inside the property in mind. “Well, why did you say it did?” asked John.
“Well, you see, we found a lot of people wanted to buy fences that keep dogs in, and we could make a lot of money if our fences did that so we did a very comprehensive study on if dogs would escape through the gaps” explained the salesman. “We put a dog in a yard with the fence with a large bowl of dog biscuits and watched it for ten minutes. The dog never left the property, so obviously the fence kept it in.”.
It was about this point that John lost it completely and started shouting at the salesman. “Are you insane?” he yelled. “Did it not occur to you to, maybe, test the fence without a large bowl of dog biscuits keeping the dog occupied, or for longer than ten minutes?”
Reluctantly, the salesman confirmed that they had conducted tests according to the conditions John was suggesting. “Unfortunately, in those tests the dog left the property, so we were forced to discard the results because they were inconclusive. For the results to properly conclude that the fence kept the dog in the property the dog would need to not leave the property. If that conclusion wasn’t reached, obviously the test results were inconclusive.”. John hung up the phone and called his lawyer.
At this point you’re probably saying to yourself that this situation would never happen in real life. You are probably correct in that assumption when it comes to the fencing industry. Not when it comes to the pharmaceutical industry though. For decades drug companies have been promoting – and settling lawsuits over the illegal promotion of anti-psychotic medications for unapproved and off-label indications. A short list of those settlements (which make up a substantial portion of the top 10 drug settlements of all time).
You might say, “but that’s not quite what happened in your story with John. With John there was no chance at all the fence would work. With the drug companies it is just a case of the FDA being strict”. - Well, not quite. AstraZeneca were found to have buried several studies related to significant weight gain and diabetes risks from treatment with Seroquel, while having released a case study of one individual who lost weight and was able to discontinue diabetes medication in its promotional material. They intentionally created a false narrative that the drug did the very opposite thing the data was saying. Their efforts to “neutralize customer objections” about diabetes and weight gain were revealed in company documents released during the lawsuit.
- Bristol-Myers Squibb and Otsuka American – Ablify – part of a $515m settlement including promotion of the drug for paediatric and dementia patients.
- Eli Lilly – Zyprexa – $1.415b for promoting it for the treatment of a long list of off-label uses including agitation, aggression, depression, dementia and generalised sleep disorder.
- Pfizer – Geodon – part of a $2.3b settlement including promotion for off-label uses.
- AstraZeneca – Seroquel - $520m settlement for promotion for off-label uses including anxiety, ADHD, depression and sleeplessness.
- Johnson and Johnson - Risperdal – part of a $1.391b settlement including promotion for off-label uses for dementia patients to treat agitation, hostility, depression and anxiety.
You might also say that the problem has been addressed, so it should not be a problem anymore. Again, not quite. Bristol-Myers-Squibb settled the lawsuit mentioned above back in 2007. They settled another lawsuit for off-label promotion of Ablify in 2016. Pfizer has settled multiple lawsuits over off-label promotions in the same period. It is quite apparent that illegal promotion and settling lawsuits has become a standard business practice in the pharmaceutical industry. The two main indications approved for antipsychotics are schizophrenia and bipolar disorder. The lifetime (meaning it includes those that have not yet developed the disorder) incidence of those disorders is less than 1% of the population. Not all those people will require antipsychotics to treat it and a similarly large number will have no access to healthcare to even have them prescribed. The number of people prescribed antipsychotics in the United States as of 2014? Nearly seven million, including paediatrics and seniors.
You might argue that your doctor knows best. Do they? Where do you think your doctor gets their information from? Some of it comes from the FDA, but pharmaceutical companies spend a quarter of their multi-billion-dollar revenues (note: revenues, not profits, it’s an even scarier large number) on marketing. The vast majority of the information your doctor relies on comes from the same dishonest companies who falsify data and make claims their products are effective for conditions they are not approved or proven effective for.
You might finally ask, what is the big deal? Antipsychotics are linked to an increased risk of death. Deaths have been attributed to the use of antipsychotics and lawsuits have been settled over deaths attributed to antipsychotics. The serious side effects list of antipsychotics is massive, but three of the most serious are obesity, diabetes and tardive dyskinesia. Even in small doses as a sleep aid the risk of diabetes is significant according to studies.
If you are concerned about a medication your doctor has prescribed you, do yourself a favour and ask them about it, and check the FDA website for its approved indications. Make sure you are familiar with the list of possible side effects and the frequency of them.