And don’t ask any questions. Capish?
The results of more than half of all clinical trials that demonstrate the safety and effectiveness of new drugs are not published within five years of the drug going on the market, according to an analysis of 90 drugs approved by US regulators between 1998 and 2000.
The researchers, who traced the publication or otherwise of 909 separate clinical trials in the scientific literature, wrote that the failure of drug companies to publish the evidence relating to new medicines amounted to “scientific misconduct”. They said it “harms the public good” by preventing informed decisions by doctors and patients about new medicines and by hampering future scientific work. […]
Five years after each of the 90 drugs was first available for patients, only 43% of the studies supporting the drugs’ use had been published, with most publication happening in the first one or two years. In the case of one product – an antibiotic – the researchers could not find a single supporting trial in the scientific literature, while five trials were published twice and one was published three times.
The team also found evidence for a “publication bias”. Trials with statistically significant results were more likely to be published than those with non-significant results, as were those with larger sample sizes.
One possible explanation for the scientific data not being published is that drug companies hold back publication of the results that are least flattering to their new drugs. Another possibility is that academic journal editors are less inclined to publish papers on trials that have negative or ambiguous results.
Hey, maybe we should, like, totally de-regulate the food and drug industry. That’s what John McCain would do, right? Just let the market sort out those safety concerns. That way we could cut out the lobbyist middlemen and the drug companies could pass on the savings to us extra profits to their shareholders and senior executives! Awesome!
Oh wait. I forgot. Johnny Mac says he sorta, kinda maybe likes regulation. Well, I can see his point. Without any regulation what would all his corporate lobbyist pals do for a living? Their jobs as his campaign staff can’t last forever. I mean, not all of them can work for foreign military dictatorships or the Saudis. It’s a delicate balance, getting just the right amount of regulation to keep the Washington lobbyist industry healthy. After all, it is a vital segment of the Republican our economy. If that isn’t a reason for electing a man with the caliber of John McCain’s experience in government as our next President, I don’t know what is.
Meanwhile, just take your meds like good girls and boys. Especially those sedatives and antidepressants. I’m sure they’re all perfectly safe since they’ve been approved by the FDA. Besides, the way things are headed these days, you’re gonna need them.
Remember this is just studies which were given to the FDA in support of approval for new drugs. Makes you wonder about all the studies that weren’t submitted, doesn’t it.
A good example of what you’re talking about appies to antidepressant drugs, but it is even worse than that. Every four years, some scientist reviews the “published” literature on antidepressants and comes to the same conclusion as the last one: antidepressants are ineffective or no more effective than placebos. I know that some depressed patients swear by them, and it is possible that in select groups not yet discriminated, a true effect may be available. However, as a general conclusion, the above one seems valid and replicable.
As to your main theme, about the finagling of drug trials by the pharmaceutical companies, in the early years, when it was discovered that ineffective psychotropics were getting FDA approval on the basis of drug company studies, the government ala the NIMH got into the game. That was the early 60s. By the end of the 70s, funding for government run studies was markedly diminished by the Carter administration, on the grounds that the drug companies should fund their own studies. Afterall, why should taxpayers foot the bill on products sold by the private sector?
Just read the essay. Thanks, Steven.