FDA Let Drugs Approved on Fraudulent Research Stay on the Market

[DeSwiss]

Source: ProPublica


[font color=darkgray]Retired FDA investigator Patrick Stone
(Katie Hayes Luke for ProPublica)[/font]

On the morning of May 3, 2010, three agents of the Food and Drug Administration descended upon the Houston office of Cetero Research, a firm that conducted research for drug companies worldwide. Lead agent Patrick Stone, now retired from the FDA, had visited the Houston lab many times over the previous decade for routine inspections. This time was different. His team was there to investigate a former employee's allegation that the company had tampered with records and manipulated test data.

When Stone explained the gravity of the inquiry to Chinna Pamidi, the testing facility's president, the Cetero executive made a brief phone call. Moments later, employees rolled in eight flatbed carts, each double-stacked with file boxes. The documents represented five years of data from some 1,400 drug trials.

Pamidi bluntly acknowledged that much of the lab's work was fraudulent, Stone said. "You got us," Stone recalled him saying. Based partly on records in the file boxes, the FDA eventually concluded that the lab's violations were so "egregious" and of such a "pervasive nature" that studies conducted there between April 2005 and August 2009 might be worthless.

The health threat was potentially serious: About 100 drugs, including sophisticated chemotherapy compounds and addictive prescription painkillers, had been approved for sale in the United States at least in part on the strength of Cetero Houston's tainted tests. The vast majority, 81, were generic versions of brand-name drugs on which Cetero scientists had often run critical tests to determine whether the copies did, in fact, act the same in the body as the originals. For example, one of these generic drugs was ibuprofen, sold as gelatin capsules by one of the nation's largest grocery-store chains for months before the FDA received assurance they were safe.



Read more: http://www.propublica.org/article/fda-let-drugs-approved-on-fraudulent-research-stay-on-the-market

[Downwinder]

1. Like beta testing software.

[niyad]

2. k and r--bookmarking to finish reading later, just too angry right now.

[TheMadMonk]

4. Do read, since it does appear that the FDA did nothing likely to harm...

...or allow harm to continue. What it did do, was place the financial safety of the suppliers on a par with the medical safety of the recipients.

Sadly, in America I could argue that choice both ways. The society is so litigious, that people who suffered no demonstrable harm, and moreover demonstrably DID BENEFIT from the medication prescribed to them, would still sign on to class action lawsuits in the belief they deserved compensation regardless.

Separately, but related, tort reform is indeed a truly hateful thing. Unfortunately it is also the logical outcome of a society which blames someone else for the consequences of placing near boiling liquids in close proximity to one's genitalia.

[DeSwiss]

7. ''did nothing likely to harm...''

- They did nothing, including their primary reason for existence.....



“It's a beautiful thing, the destruction of words.”
~George Orwell, 1984

[BrotherIvan]

3. This is an outrage

Can't let people get in the way of profits.

[bemildred]

5. "Research" is just part of the marketing game. nt

[DCKit]

6. "Regulatory Capture"

You might call it "the revolving door."

[forestpath]

8. Is there ANYTHING the Obama administration believes in protecting us from?

Drug companies can poison us, banks can steal our homes, food companies can literally serve us shit.

What is the point of the Obama administration again?