Only half of all clinical trial results are published. Favorable results are twice as likely to be released.
Your doctor only knows half of the research on the medication they just prescribed to you. Scary, right? That’s not all: Governments, regulators, and scientists are similarly left with limited data.
A study published in the New England Journal of Medicine estimates that only half of all clinical trial results are published. Results that are published are twice as likely to favor the medical treatment.
Similarly, a PLOS Medicine study found that half of the research on new medical treatments under reports adverse events. Though 95% of research contains adverse effects, only 46% of published documents include them.
So, what does this mean? It means that drugs are approved, regulated, and prescribed based on skewed data. It means that taxpayer dollars are wasted by scientists unknowingly repeating the same clinical trials over and over again. And it means that patients receive medications that may do them more harm than good.
A “Cancer” at the Heart of Medical Research
It’s easy to understand why drug companies are more likely to hide negative clinical trial results. But universities and non-industry sponsored researchers are even more susceptible to leaving out data.
Starting in 2007, the FDA required that all clinical trials are registered and their results published within one year of completion on ClinicalTrials.gov.
However, the New England Journal of Medicine study discovered that of the clinical trials registered, only 13.4% of trials reported their results within the one-year time frame. While 17% of industry trials were published, only 8.1% of NIH-funded trials were, and a mere 5.7% of university and other government-sponsored trials were released. Five years on, still less than half of clinical trial results were published.
“If I conducted one study and I withheld half of the data points from that one study, you would rightly accuse me, essentially, of research fraud,” said Ben Goldacre, creator of the AllTrials campaign, in his popular TED Talk. “And yet, for some reason, if somebody conducts 10 studies but only publishes the five that give the result that they want, we don’t consider that to be research misconduct.”
The problem is more complex than protecting profits. Medical journals have to change their publishing incentives, Goldacre says. Studies that flop rarely get accepted for publication.
Doctors Rely on Distorted Information
With only half of the information, doctors can’t know all the possible side effects of a medication, if its benefits outweigh the risks, or whether or not it is better than cheaper alternatives.
“You want to do the best for the patient, but if you can access only half the information, then a decision on choosing a particular drug or device might not be as reliable as you’d like,” said Yoon Loke, one of the PLOS Medicine study researchers.
Even with the journal results they do have access to, psychiatrist Erick Turner told LiveScience that most physicians lack the statistical knowledge to understand how reports can distort results.
“If the average physician believes that every trial done on a drug is positive, they’re going to have a very rosy impression and perhaps pooh-pooh [other] treatments that might also be effective,” said Turner.
An Unpublished Study Costs 100,000 Lives
If researchers had released the results earlier, they “might have provided an early warning of trouble ahead.”
Lorcainide offers a classic example of the importance of publishing failed trials. Created in the 1960s, it was an antiarrhythmic medication that helped restore regular heartbeats in patients.
Its 1980 clinical trial was a failure: Nine of the 49 participants on Lorcainide died, while only one of the 46 who received a placebo died. The company didn’t release the results.
Without knowing the outcomes of the trial and its deadly consequences, other manufacturers pursued their own antiarrhythmic medications. It’s estimated that more than 100,000 people died because of it.
The researchers finally published Lorcainide’s clinical trial results in 1993, and wrote that if they had released them earlier, they “might have provided an early warning of trouble ahead.”
Billions of Government Money Wasted on Tamiflu
After five years, Roche released the results of all 70 clinical trials, showing that Tamiflu was largely ineffective.
Even if a drug is relatively harmless, withholding results can result in a waste of money if a medication isn’t as effective as its data claims it is.
Tamiflu, an anti-influenza drug made by Roche, didn’t publish the results of 70 clinical trials. The results they did release presented Tamiflu as more effective than comparable drugs for preventing flu complications and reducing symptoms.
Governments around the world stocked up on the drug in preparation for the next flu outbreak. Britain spent £473 million and the U.S. spent $1.3 billion on Tamiflu and other anti-viral medications.
After five years, the Cochrane Collaboration, a nonprofit in Britain, was able to persuade Roche to release all 70 trials. They discovered that Tamiflu didn’t prevent hospitalizations or flu complications. At best, it just reduced symptoms by one day.
These weak benefits didn’t outweigh the risks for many patients. At least 70 people committed suicide while on Tamiflu, and many others suffered from temporary bipolar disorder, schizophrenia, and other psychotic episodes.
New Rules Ignore Problems From the Past
“Selective reporting…leads to an incomplete and potentially biased view of the trial and its results.”
Regulators and companies like Roche have committed to greater transparency, offering some hope for the future. In 2015, the World Health Organization (WHO) warned that, “Selective reporting, regardless of the reason for it, leads to an incomplete and potentially biased view of the trial and its results.”
Perhaps recognizing that the FDA’s existing rule is ineffective, the U.S. Department of Human Health and Services published a final rule on clinical trial reporting in September 2016, which goes into effect later this month. The rule has been expanded to include trials that have yet to be regulated by the FDA, ensuring that all results—regardless of whether a medication is eventually sold—are released.
However, even if every trial is published going forward, we’re still saddled with erroneous decisions from the past. In order for doctors and scientists to get a complete understanding of every medication that is currently prescribed, we have to publish historic data.
Are You Suffering From Adverse Effects?
With this pervasive cover-up culture, it’s no wonder that we frequently hear of harmful medical treatments. If you are suffering from complications caused by your medications, you may be entitled to compensation. Contact ClassAction.com today for a free, no-obligation legal review.