Out of sight, out of mind–and out of the FDA’s reach.

Big Pharma has been outsourcing clinical trials at an alarming pace–but it’s not just to save a buck.

It’s to save their meds, because it’s much easier to get favorable results for iffy drugs when the research takes place far from prying eyes and pesky regulators.

A new report in Vanity Fair, of all places, revealed that there were 6,485 overseas trials for drugs aimed at Americans in 2008 alone–up from 271 in 1990.

And if you think standards here have sunk, you should check some of these places out.

In one case, researchers analyzing the results from a drug trial in Iran found nearly all of the results to be fraudulent, according to the magazine.

And when they’re not faking data, they’re stacking the deck.

One trick you can only pull off overseas is to load your trial with “drug-naïve” patients–people who’ve never taken a med in their entire lives. These people almost always respond better to drugs than, say, the average American who’s been taking medication for years.

And since many Third World volunteers–some of whom are even homeless people–are in poor health to begin with, it’s much easier to write off side effects.

Even deadly side effects.

But that’s only part of the story–because the report also exposes what the FDA won’t talk about: Today’s drug studies are no longer the domain of dogged researchers on the verge of scientific discovery.

It’s a for-profit enterprise that’s been seized by subcontractors paid to deliver results–and do they ever deliver.

If you’ve ever looked at all the drug warnings and recalls lately and wondered how so many bad meds managed to slip through the cracks, you’ve inadvertently admired their handiwork.

Overseas trials helped give us Avandia, Celebrex and the notoriously bad antibiotic Ketek–just to name a few. In fact, up to 80 percent of all new drug applications submitted in 2008 featured data from overseas trials.

The FDA told the New York Times that it has the power to reject overseas data–but I’d love to see hard numbers on how often that happens.

Here’s my guess: About as often as the feds manage to inspect those overseas trial sites.

In other words, almost never–because in 2008, they visited just 0.7 percent, or 45 of the 6,485 sites.

What does this mean for you? Take every new drug approval with a huge grain of salt. The meds that made it through the system before research shifted overseas were bad enough.

Now, expect a new wave of drugs that are even worse.

Do you think customer service has gotten better since companies began outsourcing their call centers to other countries?

Well, me neither.

Now imagine what that same approach would do to medical research. Except you don’t have to imagine it at all – because this is our frightening new reality.

In fact, as of November 2007, a third of all clinical trials were being conducted overseas, in many cases in Third World countries, according to a report in the New England Journal of Medicine. At the same time, fewer clinical trials are being carried out in the United States and Western Europe.

These developing countries are of course less expensive to work in. A top-flight medical center in India charges between $1,500 and $2,000 per case report, a tenth of what even a second-tier institution here in the United States would demand.

But it’s not just cheaper. No, saving money is just a side benefit of moving these studies abroad. The real reason Big Pharma likes working in developing nations is so they don’t have to deal with that pesky FDA oversight so much. Researchers in many other countries can often carry out clinical trials with little to no review at all.

In fact, Big Pharma may have pushed our friends in India just a little too far. The authorities there are investigating the death of a baby involved in a vaccine trial. A baby! The poor child had a preexisting cardiac disorder, according to reports, and never should have been part of the study to begin with.

Still, in many cases researchers seem to work outside of the system. The authors of the report found one study in which 670 researchers in developing countries were asked if local or national health officials had reviewed their work. Nearly half said they did not.

Do you really think Big Pharma hasn’t noticed that?

The FDA is often shortsighted and narrow-minded, but even their imperfect oversight is far better than none at all.

I’ve spent much of my adult life reading and studying the results of clinical trials. And believe me, it ain’t easy.

There’s an art to reading medical reports, because there’s always a devil or two hiding in the details. Some are poorly designed, and in those cases the problems leap right off the page. But in other cases, researchers with dubious motives intentionally try to misrepresent their conclusions and manipulate data.

They’ve been doing that for years with studies based in the United States and Europe, where there is some oversight and scrutiny.

Just imagine what they’re doing now behind your back.