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.