Drug research: fraud and errors are life-threatening

More and more people seem to be becoming aware of the manipulation of drug research by the pharmaceutical industry. Insiders have long known about drug malpractices within this industry. While pharmaceutical companies can in some cases be a great contributor to society, their greed is so compulsive and prevalent that to a drug manufacturer, profit is far more important than the health of its customers. Unfortunately, victims ensue—and sometimes the outcome is fatal. Can we trust the pharmaceutical industry at all?

By C.F. van der Horst
March 15, 2016, updated September 12, 2022
Photo: Pikrepo

Like any other business, the pharmaceutical industry must make a profit. There is nothing wrong with that. However, when the profit motive comes at the expense of people’s health or even lives, it becomes a very bad thing. As you will read in the book Deadly Lies: How Doctors and Patients Are Deceived , drug manufacturers have a long history of unethical practices, with the wanton falsification of drug trials perhaps being the most shocking.

“Deadly Lies. How Doctors and Patients Are Deceived” describes the conflicts of interest of government officials and scientists, the mass marketing of the pharmaceutical industry, and the lies used to deceive both physicians and you.

The book documents in detail the marketing strategies and methods of the pharmaceutical industry. This includes the use of scientists. They are essential to give credibility to the claims of the effectiveness and safety of medicines. Physicians read drug research reports in their professional journals or in brochures offered in their CME (Continued Medical Education, which is provided in most cases by industry), at conferences, or handed out by pharmaceutical representatives.

A scientific article with a positive outcome provides sufficient basis to prescribe a (new) drug, a doctor reasons. And if that article is truthful, he may be right. But what if the research or publication of findings has been manipulated and a drug is presented as more effective and safer than it really is?

Is drug research and its resulting publication always reliable? Not so, according to Jon Jureidini. Daily De Volkskrant wrote: “‘We must stop taking scientists at their beautiful blue eyes,’ says Jon Jureidini. This Australian child psychiatrist and researcher is the driving force behind an international group of scientists who are vacuuming up suspect drug research – based on the original research data. ‘We always thought science corrects itself, but here the system has failed. And this is not an incident, I’m afraid.'” He made this statement after a reanalysis in which he discovered that scientists had manipulated their drug research, Study 329. It concerned the antidepressant paroxetine (US brand name Paxil, UK brand name Seroxat). The researchers had concealed and distorted data. Their publication with the findings of the study suggested that the drug was safe and effective in young people. The manufacturer of paroxetine, GlaxoSmithKline (GSK), had announced the positive results of the study with much fanfare in the leading British medical journal. As a result, paroxetine sales increased by 36% in just one year. According to the researchers, the drug gave significant improvement over placebo and was safe to use in teenagers. The reanalysis, however, revealed the extent to which the study had been falsified.

Child psychiatrist Jon Jureidini speaks out on the reliability of drug research@2x

Child psychiatrist Jon Jureidini speaks out on the reliability of drug research. Photograph: Mad in America.

The reanalysis found the exact opposite of manufacturer GSK’s marketing claims: the substance worked no better than a placebo. Moreover, it was already clear in the original study that paroxetine had suicidal ideation (the capacity for or the act of forming or entertaining ideas) or behavior as side effects. However, these were hidden away under a different (false) name in the study, The New York Times reported. The drug proved dangerous: there were 2.6 times as many adverse events, 4 times as many psychiatric problems and 10.3 times as many suicides compared with the control group.

GlaxoSmithKline (GSK) manipulated the drug trial of paroxetine.

It was the second time that research fraud by GSK had been exposed. From 1999-2007, GSK crossed the line after the company covered up research data on Avandia (rosiglitazone, a type 2 diabetes drug). GSK is not the only pharmaceutical company that is involved in fraud. Pfizer covered up risks of drug Vioxx (rofecoxib). Between 88,000 and 139,000 people became victims. The French company Servier Laboratories defrauded with Mediator (benfluorex). There are others.

The times when a drug manufacturer advertises its drugs off-label, i.e. without approval based on scientific research, are not yet considered—these infringements of the law are much more numerous (see Deadly Lies: How Doctors and Patients Are Deceived).

Manufacturers’ marketing is based on publications of randomized clinical trials. How reliable are the articles describing the findings of these studies? One must treat it with great caution. Not surprisingly, there is now a special term for fraudulent or worthless drug research: zombie study. The word describes randomized clinical trials whose data are patently implausible.

In 2021, an article appeared in The BMJ with the telling title “Time to assume health research is fraudulent until proven otherwise?” Author Richard Smith, editor of The BMJ to 2004, illustrated the unreliability of published drug trials with numbers. From a recent analysis it appeared that 8% of clinical trials are zombie studies and another 14% contain erroneous data. Examination of individual patients’ data revealed that 44% contained unreliable data and 26% were zombie studies.

For published clinical research, very clearly applies: Caveat lector (reader beware).

In addition to the serious issue of fraud, the matter is made worse by the fact that drug manufacturers persist in illegal marketing or manipulated drug research despite huge fines. So these are not mistakes from which to learn, but intentional deception. It has every appearance that any fines will be factored in as part of the marketing costs. After all, compared to the huge profits made, the fines are relatively low. In response to the cash penalty Pfizer had to pay in 2009, The New York Times wrote: “While the government called the fine a record amount, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales.”

According to Danish professor Peter Gøtzsche, general practitioners cause at least one death per year due to incorrect medication and/or side effects. He calculated that more than 500,000 people over the age of 65 die each year in Europe and the US because of psychiatric drugs. For example, he found major errors in the drug research of Effexxor (venlafaxine) and Prozac (fluoxetine). In reality, the drugs work no better than a placebo, yet are associated with suicide (15 times more than the FDA states!) and even homicide. Careless or manipulated drug research puts dangerous drugs on the market that kill people. The Danish professor went so far as to compare the pharmaceutical industry to organized crime.

It is not only the pervasive fraud and drug tampering by pharmaceutical companies that is of grave concern. Also the quality assurance system is found not to be functioning. Authorization bodies such as the Medicines Evaluation Board (MEB) in the Netherlands do not ever do research themselves. They only assess whether the manufacturer has done the drug trial properly. However, there are so many ways to commit fraud in such a study and make the outcome appear positive that this practice is woefully inadequate. The MEB should be conducting independent research. The abuses in drug research have proven this conclusively by now.