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The Government Accountability Office: “Pay to Play” at the FDA

There is a flood of contempt soaking Washington this summer. The Supreme Court just stunned us with a ruling that hardly anyone expected (especially the media, which immediately started spouting the opposite outcome).  We have an Attorney General being held in contempt of Congress — the first time this has happened in the history of our nation.  We have governments that will protect you from drinking a Big Gulp soda, but will leave you stranded when an entire state goes up in flames.  Americans’ faith in their institutions has eroded to close to zero.  At least we know the private pector is doing fine.

But now, an unlikely source of faith restoration has surfaced – The Government Accountability Office.  The GAO is an arm of a congressional subcommittee. It is buried under the House Energy and Commerce Committee’s Subcommittee on Investigations and Oversight.  Normally, it gets about as much respect as the Ministry of Silly Walks. One of its responsibilities is overseeing the process by which new medical devices and drugs are approved.

In 2009, a medical devices company called Device Med-System created a new product called Adhesiabloc.  Adhesiabloc was meant to clean out the GI tract of patients who have surgery on their digestive system.

In order to get this product approved by the FDA, Device Med-System had to run studies on the product.  And in order to conduct those studies legally, the company needed approval from an Institutional Review Board (IRB).  The FDA won’t approve any device or drug that has not been tested under the watchful eye of an institutional review board.  But to make sure that the IRBs know their stuff about conducting complicated experiments in a way that yields useful data, every IRB must be certified to meet certain standards by the Department of Health and Human Services.

That sounds reassuring. FDA. HHS. IRB. With that many acronyms you know something good will happen.  LOL.

Here is what happened to Adhesiabloc.  Device Med-Systems drew up plans to have it tested, and it submitted those plans to three different HHS-certified IRBs. The first two IRBs turned them down, saying the experiments themselves were too risky.  But a third IRB, called Coast, approved the plans.

There is now only one thing keeping Adhesiabloc from thousands of patients who could benefit from it:  It’s that Adhesiabloc doesn’t exist.  Adhesiabloc is completely fictional, as is the faux company that was paying for its testing.  They were made up by the Government Accountability Office in order to test whether or not IRBs were actually doing their job of weeding out sound science from rotten experiments.  The GAO even put some serious red flags in the experiment (the instructions read that one liter of the Adhesiabloc was to be poured into each patient’s stomach).  Not one single IRB did enough research on the experiment plans to find that the entire proposal was a farce.  The IRBs make profit by running clinical trials, so of course they want to run as many trials as possible.  Mo’ drug testing, mo’ money, mo’ problems.  The IRBs get paid by drug companies – and then purport to be a fair and ethical judge of how those companies run their clinical trials.

The GAO found some big cracks in the IRB system.  And who’s responsible for certifying those IRBs?  For making sure that each IRB, with the power to approve or deny plans for drug testing, meets certain ethical requirements?  Why, that would be the Department of Health and Human Services!  Having found dismal results at the IRB level, the GAO went to find out just how bad things were higher up the food chain.  It created a fake application for a fake IRB.  The application was not only chock full of red flags – it was waving those flags in the face of the HHS.  The Phake Medical Devices Company, sponsored by April Phuls and Timothy Wittless and located in Chetesville, Arizona, applied for IRB certification…and the application sailed through without a hitch.

The mainstream media may have paid no attention to this failure of government, but you know who watched this unfold and learned from it?  Drug companies.  They found out that it’s frighteningly easy to get away with unsound science.  It’s even easier overseas, where the FDA inspects less than one percent of all clinical trial sites.  We should not be surprised that these trials are moving overseas faster than ever before, and that human rights abuses abound…because less than 1% of all the overseas testing sites are ever paid a visit by someone from an oversight agency.

Every time a new drug or procedure is submitted to the FDA for approval - the manufacturer and the FDA negotiate a price, usually around one million dollars, to cover the FDA’s cost of reviewing the drug.  The higher price,  the faster the track.  It’s like when you go to Disneyworld and can pay extra for a “Fastpass” so you don’t have to wait in line for the rides.  Except here, the “Fastpass” costs upwards of a million dollars, and the ride is approving drugs faster than you can figure out whether or not they work.  Washington is a small world, after all.

Drug companies are subtly buying the FDA’s stamp of approval.  And just two days ago, the Senate voted overwhelmingly to expand this “user fees” program from its current $500 million volume into a $6 billion flow of money from drug companies to the FDA.  This was a vote that happened quickly.  When Congress does anything quickly – it ought to take you by surprise.  They just cranked up the engines on the circular ride of “drug companies pay FDA for approval, FDA grants approval which allows drug companies to make money.”  It’s the spinning Disney teacups, if the teacups were full of drugs.

So, this is bad. But we have seen it before with bond insurers, bank regulators, Fannie, Freddie…it’s a long list.  And you know what just about everything on that list has in common?  Failure, on a massive scale.

The HHS which certified the Phake Company is the same HHS which now controls all aspects of health care.  We may not trust the HHS – but now, we are forced to buy insurance through the system that they regulate.  The HHS is full of parasites – rogue invaders of the body who keep it from carrying out its health functions.  The HHS needs to clean out its digestive tract.  And for that, it sure could use some Adhesiabloc.

Angela Morabito | Georgetown University | @_AngelaMorabito

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4 Responses

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  1. Betty
    Jul 01, 2012 - 05:10 PM

    Well said Angela! If it weren’t so scary serious, HHS is becoming a laughingstock. When the “trickle down” effects of this radical, overwhelmingly unpopular socialistic health care program become fully implemented, it will be interesting to see who the Democrats have left to blame when the middle class refuse to pay for this burdensomeTAX INCREASE.

    Reply
  2. Terry
    Jun 29, 2012 - 04:26 PM

    Fun to read conservatives complain about the lack of respect for the GAO during only Democratic administrations!

    Reply
    • Sean L
      Jun 30, 2012 - 01:53 PM

      Like how liberals only appreciate it during Republican administrations?

      Reply
    • Sean L
      Jun 30, 2012 - 02:17 PM

      And now that the Supreme Court has eliminated over 200 years of jurisprudence, you call it wise. But if the decision had gone the other way, you would be screaming that the Court had succumbed to bullying the Tea Party.

      Reply

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