How lackluster drugs become blockbuster drugs

Wellbutrin. Chantix. Lipitor. They’re all big-name, blockbuster drugs that make billions for Big Pharma. But how much do we really know about them?

Certainly not as much as we’re led to believe.

As I pointed out last month, Big Pharma likes to publish studies that show ONLY positive outcomes for their drugs. And they bury the studies that show their drugs don’t work.

Case in point?

In 2008, a British researcher named Irving Kirsch and his team conducted a major analysis of antidepressants. For the first time ever, they gained access to a mother-load of unpublished clinical trial data on antidepressants. The researchers actually had to file a Freedom of Information Act (FOIA) request to get to the data!

And what they found was astounding.

When they examined the new, unpublished data, they discovered that antidepressants benefit the patient even less than what we had originally been told.

Overall, researchers said they found “little evidence to support the prescription of antidepressant medication to any but the most severely depressed patients.” In other words, for most people, the drugs just don’t help unless they have severe depression.  (Fortunately, research shows that herbs like St. John’s wort can help mild-to-moderate depression.)

How does Big Pharma get away with this?

Believe it or not…it happens quite a lot. In fact, according to an analysis published late last year in the British Medical Journal, almost one-third of all major clinical trials never get published. The raw data from the trial never even sees the light of day. And we never learn about what happened.

For this analysis, researchers from the University of North Carolina Chapel Hill looked at all the clinical trials registered with clinicaltrials.gov in recent years. (In 2007, the FDA began to require all phase II, III and IV clinical trials to register with clinicaltrials.gov. They’re also supposed to report their data to clinicaltrials.gov.)

The researchers only included trials that involved at least 500 participants in their analysis. They did this for a few reasons. First, this limited the possibility that the trials went unpublished because they included smaller numbers of people.

You see, in the research world, small clinical trials tend to be dismissed because they “lack statistically significant findings.” So, perhaps one could justify not publishing the data.

On the other hand, you can’t argue that a clinical trial with at least 500 participants lacks significant findings. It’s a good cut-off point. And the scientific world should have access to the findings from these large-scale trials. Whether they’re positive OR negative.

So, using this criterion, the North Carolina researchers turned up 585 registered trials. But 29 percent of these large trials never got published. And they remained unpublished five years after they registered with clinicaltrials.gov.

Plus, more than three-quarters of the unpublished studies never even reported their data to clinicaltrials.gov.

Why’s that such a big deal?

Well, as I said, researchers are supposed to report their raw data to clinicaltrials.gov. Even if they don’t wind up publishing it in a medical journal. In a way, clinicaltrials.gov helps keep the research world transparent and honest. Plus, it’s supposed to help safeguard study participants. And it’s supposed to benefit the scientific community.

But a whopping 75 percent of these trials never reported their data. It’s as if the trials never happened. We don’t know anything. We don’t know their results…good or bad. (Though, I’d wager that the unpublished/unreported trials didn’t show favorable results for whatever drug they were testing.)

We only know that they did happen. And that they involved more than 300,000 participants! In a way, this is the biggest crime.

You see, clinical trial participants expose themselves to many risks when they receive unproven treatments. They do this knowing that society will benefit from what researchers learn during the trial. And if the treatment didn’t benefit the participants…that information is still important to society as a whole. And if the treatment harmed the patients, that information is even more important!

The North Carolina researchers uncovered another interesting trend…32 percent of trials funded by Big Pharma never got published. By comparison, just 18 percent of trials funded outside the pharmaceutical industry remained unpublished.

What is the drug industry trying to hide?

Poor results–one can only assume.

Thankfully, some authorities inside the research world are finally acknowledging this problem. In fact, an editorial published last month in the British Medical Journal suggested that medical journals stop publishing any and all research funded by the drug industry.

Citing a book by Peter C. Gotzsche called Deadly Medicines and Organized Crime: How Big Pharma Has Corrupted Health Care, the BMJ editors argue that we can’t rely on results that come out of drug industry-funded trials. They say scientific journals should only publish papers carried out by independent researchers. And funded by public sources. Such as academies, universities, and government agencies.

They pointed to the recent meta-analysis of statins, issued by the Cochrane Collaborative, as a case in point. That analysis reflected quite positively on benefits of statin drugs. Now here’s a surprise…Big Pharma funded all the trials in that meta-analysis. The BMJ editorial staff argues that we can’t rely on such analyses in terms of safety and effectiveness in the population.

Here’s another big problem…

Big journals are more likely to publish studies funded by drug companies rather than smaller, independent studies. Is it any wonder that most of these journals are full of paid advertisements about the same drugs for which they published the studies? Plus, Big Pharma only submits studies to these journals that show positive results. The negative studies go off into never-never land.

So there’s double bias. And vast amounts of data go unpublished. This shouldn’t happen in a free and transparent scientific community.

Without a doubt, the game is rigged. And not in your favor. No wonder so many lackluster and dangerous drugs turn into “blockbusters.” They simply leave important science unpublished. And they keep the patients and their doctors in the dark.

Source:

  1. “Non-publication of large randomized clinical trials: cross sectional analysis,” British Medical Journal, October 29, 2013, published on-line.

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