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FDA Approved New Drug Despite Ongoing Investigation of Lab Misconduct

We’ve reported that the FDA has allowed drugs to stay on the market despite the fact that the research underpinning their safety and efficacy was tainted by fraud. New information shows that even after the FDA had cited the lab for falsifying data, the agency issued at least one brand new approval to a drug tested there.

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(The Food and Drug Administration)

Last week, ProPublica reported that the Food and Drug Administration allowed dozens of medications to stay on the market, even though the research designed to prove their safety and effectiveness was undermined by "egregious" violations at a major pharmaceutical research laboratory in Houston. New information shows that even after the FDA had cited the lab for falsifying data and other misconduct, the agency issued a brand new approval to a drug tested there.

The FDA has refused to reveal the names of any of the approximately 100 drugs affected by the fraud at the Houston lab of the firm Cetero Research, saying that to do so would reveal confidential commercial information. ProPublica was able to identify five of those drugs, and now we’ve found a sixth. This one was approved after the agency had already cited the Houston lab for misconduct.

The drug is a generic version of Tussionex, which combines a long-acting narcotic cough suppressant with an anti-allergy medication. Manufactured by TrisPharma, the drug has a tongue-twisting chemical name: hydrocodone polistirex/chlorpheniraminepolistirex.

ProPublica discovered that both of the clinical trials used to show that the generic is equivalent to the name brand — a key requirement for FDA approval — were analyzed in May and June 2009 at the Houston lab of the firm Cetero Research. The company, which conducted research for scores of pharmaceutical companies, has acknowledged that chemists at its Houston lab committed research fraud, though it says the misconduct was limited to a handful of employees and that none of their tests have so far proven to be wrong or inaccurate.

Cetero filed for Chapter 11 bankruptcy last year and emerged with a new name, PRACS Institute. PRACS, in turn, filed for bankruptcy earlier this year.

The FDA got wind of problems at Cetero Houston in June 2009 when, prompted by a whistleblower, the company alerted the agency of potential wrongdoing.

On May 3, 2010, three FDA agents came to inspect the lab. The facility’s president turned over eight flatbed carts double-stacked with file boxes and admitted that much of the lab’s work was fraudulent, saying, “You got us,” lead agent Patrick Stone recalled. (The lab’s president declined to comment.)

On May 7, the FDA issued an inspection report that cited data falsification and other laboratory violations at the facility during the time its chemists conducted the tests for the TrisPharma drug.

But five months later, in October 2010, the FDA approved Tris' drug for sale in the United States.

The FDA continued to inspect the Houston lab, and in July 2011, the agency called the lab’s misconduct so “egregious” and pervasive that more than five years of tests conducted at the lab were potentially “unreliable.” The agency asked pharmaceutical companies to repeat or reanalyze any tests conducted there during that time if they had helped win drug approval. The FDA did not pull any drugs off pharmacy shelves, despite the fact that dozens were approved on data the agency now said was questionable.

In April 2012 the FDA relaxed its requirements. The agency announced that studies analyzed at Cetero Houston between March 2008 and August 2009 — the time period in which tests for the TrisPharma drug were conducted — would not need to be redone but instead would require only a "verification of data integrity by an independent third-party audit."

Tris said it hired a consultant to perform the audit and it “came back 100 percent clean," Groner said. "Something could have happened, but in our case, nothing did." He said Tris submitted the audit to the FDA in the second quarter of 2012.

The FDA has reviewed the audit and found it “acceptable,” an agency spokesperson wrote in an email. “Our earlier determination that this product meets FDA standards was upheld.” She declined to add any information or answer more specific questions.

The main point of that audit was to look for red flags that researchers might have cooked the books, said Scott Groner, TrisPharma’s Director of Regulatory Affairs and Compliance. The Cetero researchers ran blood samples through a machine known as a mass spectrometer. By examining the timestamps of these runs, Groner said, the auditors could tell whether or not a rogue researcher would have been able to tamper with the results of the experiment. "If there was some manipulation, there would have to be some down time" for the researcher to fiddle with the samples or the machine in order to produce the desired result, he explained. Auditors, he added, “were looking for many other things. Were [experiments] done late at night, on weekends?"

While the FDA declined to comment on the specifics of the Tris Pharma case, the agency has previously said that it ran a risk assessment and concluded that the chances were low that drugs tested at Cetero Houston were unsafe. The fact that the FDA has since found no problems with drugs tested there “confirmed” that risk assessment, a top FDA official said.

As of last week, the agency said it had completed reviewing 21 out of 53 submissions it had received from pharmaceutical companies that had medications tested at Cetero Houston. It also said a few companies had not yet submitted new data or audits on drugs tested there.

Rob Garver can be reached at rob.garver@propublica.org, and Charles Seife can be reached at cgseife@nasw.org.

Short version:  The FDA sides with the big companies and the big companies don’t care about health if it impacts sales.

But we all knew that.

I mean, you’d think it would be against the law to continue to sell a drug if the test data was tainted, no?  It’s like the test never happened, and it’s against the law to sell untested drugs.  But I guess not…

The FDA is propping up a marred industry. I suspect if we dig a bit deeper we will find that some of them are selling their votes just as our crappy politicians do. The net result over time will be to severely damage a very important industry that has, in distant past, been a boon for mankind. As an old lab guy who has seen positive direct results of some great drugs on deathly ill patients, I shudder at what could happen to this industry. The FDA needs a serious shakeup now.

Yeah , John and the FDA protects the identity of the fraudulent lab, then it blames the fraud on some employees. Aha. It seems that the employees were the only ones to benefit from the medication scam.

What world is this ?

For the purpose of making money some people don’t care about their health and the health of others. Is stupid. And I think the FDA is just as stupid because they’re just part of the silly game.

This story just confirms how organized corrupt businesses work.

How and who can shake the FDA if the lobbies in DC manipulate everything Claudem?

Thanks ProPublica .

Good reporting. Not enough people read pp. Where is the outrage?  Congress doesn’t care. Only victims who get hurt care.

Never trust your government. The federal and its agencies are the other arm of Corporatocracy. I bet you thought they had the best interest of America’s children in mind. Wrong.

So why wasn’t the president (“You got us”) led away in handcuffs and facing a long prison sentence?

We’re reminded of the Bush-Administration torturers and the criminal bankers that crashed our economy, who also are above the law.

The pervasive unaccountability is just one symptom of the corruption in our fascist system.  We have corrupt government-corporate partnerships where, for example, the FDA sees the the drug corporations it was created to regulate as its clients— not the American people.

These problems are so widespread and ingrained that they must be addressed politically.

The first step is to STOP voting for the two corporate-funded parties that are selling us out to the 1%.

The Green Party is the non-corporate alternative; they don’t accept corporate money and they represent CITIZENS’ interests.

And no, they DON’T need 51% of the vote in the very next election to make a difference. 2-4% of the vote is enough to send a message to the Democrats that continuing their business-first agenda will cost them votes, and will eventually cost them elections. Many races between the corporate parties are decided by less than this margin.

A mere 5% of the vote for the Green Party will get them millions in matching Federal funding.

Don’t be fooled into playing the rigged game of the corporate-funded parties: VOTE GREEN!

So why wasn’t the president (“You got us”) led away in handcuffs and facing a long prison sentence?

We’re reminded of the Bush-Administration torturers and the criminal bankers that crashed our economy, who also are above the law.

The pervasive unaccountability is just one symptom of the corruption in our fascist system.  We have corrupt government-corporate partnerships where, for example, the FDA sees the the drug corporations it was created to regulate as its clients— not the American people.

These problems are so widespread and ingrained that they must be addressed politically.

The first step is to STOP voting for the two corporate-funded parties that are selling us out to the 1%.

ProPublica was able to identify five of those drugs, and now we’ve found a sixth. This one was approved after the agency had already cited the Houston lab for misconduct.

I’d like to know the name of the other 5 medications.

if you want to know the names of the six drugs identified just click on the link within the article ‘found a sixth’ and it will give you the list.

agreed! never, ever simply trust anything or anyone. no blind faith.

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