You expect Big Pharma to cheat, lie, steal, and create fake data. You don't expect it from humble chemists who dedicate their lives to science.
Very often, these chemists are the only reliable things standing between you and taking an unsafe -- even deadly -- drug. You see, Big Pharma outsources much of its dirty work on drugs to medical testing companies. Chemists at these companies work "independently" to monitor clinical trials for Big Pharma. Then, they report their results to the FDA.
So what happens when humble, independent chemists turn to the dark side? They manipulate the results and send fake data to the FDA. Then you come shockingly close to taking a drug based on this "fake" data.
Take for example Cetero Research.
Shocking alleged fraud at research lab
Cetero Research runs clinical trials for Pfizer, Novartis, and AstraZeneca. This means, they recruit the patients. They develop the trial protocol (and figure out how much of the drug to give each patient and how often). They administer the drug to the patients. Next, they retest the patients to see if their various symptoms improved.
Then, the Cetero chemists report their results to the "drug sponsor." (This term makes Big Pharma almost sound like they're actually watching out for us, doesn't it?) Lastly, the "drug sponsor" or drug company presents the data to the FDA. This data helps the FDA determine whether a drug should get market approval.
So you'd think that the FDA would diligently monitor a company like Cetero to make sure their results are legit... right?
But what would happen if the company turned in fake data? You may be shocked to learn how easy it was for a group of chemists from Houston to "falsify results" and send fake data to the FDA.
Here's how easy it was...
Faster isn't always better
Apparently, Cetero doesn't hire your regular old Cal Tech chemists. They hire super-chemists.
In fact, Cetero say their chemists can give you "accelerated proof-of-concept." It means that instead of taking 28 to 36 weeks to determine a drug's viability, Cetero chemists only need 14 to 18 weeks. They get the same amount of work done in ½ the time it takes other labs!
And you wanna know how Cetero chemists got their work done so darned fast?
They apparently cooked the books – creating fake data.
The FDA looked at the clinical trials Cetero ran between the years 2005 and 2010. During this time, the chemists recorded when they took samples from patients. But when the FDA checked these times against chemists' timecards, they found something very interesting.
The chemists weren't even at the lab on those days. And it wasn't just one or two times that it happened. The FDA found 1,900 examples of when the chemists claimed to take samples on a day they didn't even go into the lab.
Now, Cetero claims the chemists did do those procedures. They just lied about when they did them. The chemists claimed they took the samples on weekends so they could get overtime pay. (I'm shocked! Chemists aren't motivated by money. They're out for the greater scientific good.)
But wait. It gets worse.
The FDA only found out about the problem because of an internal whistleblower at Cetero. A chemist with a conscience told management at Houston about the problems. But apparently management -- even the Cetero CEO -- didn't listen.
So the chemist went to the FDA. And only then did the FDA find out about the Houston shenanigans. And the uncovered a whole lot more than just timesheet troubles...
Selling your soul for drugs
Before the FDA stepped in, Cetero Research did begin an internal investigation. They say they stand by the "integrity" of their data.
But FDA's not buying it. (Shocking, I know.)
The FDA found "widespread falsification" and "manipulation" of data at Cetero's Houston lab between 2005 and 2010. In other words, completely fake data was submitted repeatedly to the FDA.
The FDA says Cetero chemists may have fixed data to meet "acceptance criterion." Basically, this means the chemists may have faked the data to make it look better to gain FDA acceptance.
Cetero's big wigs sent 483 letters to the FDA trying to explain away the bad data. But the FDA says their explanations are "inadequate." (Applause. Applause.)
As a result, the FDA is pulling all Cetero clinical trials from the pipeline for review. And according to the Fed website, 122 clinical trials contain Cetero's fingerprints. Unfortunately, the FDA didn't publish the list of questionable studies. So we don't know which studies involving which drugs Cetero might have cooked.
But the FDA believes the fake data pertains to drugs not yet on the market. So all the drugs already on the market should be good to go.
The older, approved drugs may be safe from Cetero's scams, but I'm sure this kind of thing happens a whole lot more than anyone wants to admit. Makes you wonder how many chemists cooked the books to get a drug like Actos or Boniva approved.