Monday, October 5, 2009

By Stuart Chaifetz

The Dark Side of Big Pharma V
I’ve been spending a lot of time exploring Human Clinical Trials (HCT), because they are the bridge between animal experiments and wide spread use of pharmaceutical drugs. This pivot is where millions of dollars and years of research are put to the test - a test that they fail 90% of the time. The reason why HCT’s fail so dramatically is because animals are poor models for gauging human responses to drugs.
Even though the FDA has cited certain clinical trials for fraud and abuse, their oversight is merely the proverbial drop in the bucket. For this blog, I want to show you just how tiny that drop is - and why the FDA can’t even find the bucket.

In September of 2007, the Department of Health and Human Services, Office of the Inspector General, issued a report on the FDA’s “Oversight of Clinical Trials.” Here’s what they found:
Because FDA does not maintain a clinical trial registry, it is unable to identify all ongoing clinical trials and their associated trial sites. Further, because FDA does not maintain an IRB registry, it is unable to identify all IRBs.”
Let’s deal with the enormity of these two findings. We already knew that HCT’s were potentially dangerous and fatal to the participants. Now we know that the FDA doesn’t have a clue as to how many of them there are out there. We also knew that not all IRB’s (Institutional Review Boards. See our blog from 9/22/09) are reliable and ethical - and now we know that the FDA doesn’t even have a registry of them.
These trials are potentially worth billions to Pharmaceutical companies, are open to fraud and abuse, and could effect the lives of every participant, as well as all those who will take the drugs once approved. And the FDA is clueless as to how many of these are even out there. I like to keep this blog PG-13 so I’ll not write the hyphenated phrase that came to mind when I first read this, but you can feel free to insert your expletive of choice at this time.
Want to know just how bad the situation of the FDA’s oversight of HCT’s is?
“We estimate that FDA inspected 1 percent of clinical trial sites during the fiscal year 2000–2005 period.”
Or, as I would prefer to write it, they do not inspect 99% of the experiments that happen to human beings. This is out of an estimated 350,000 trial sites, so you can see the importance of the issue.
And then there’s this:
“FDA relies on voluntary compliance to correct violations of regulatory significance.”
Yeah, this is as bad as it reads. IF a researcher is caught doing something wrong, they get to clean it up. It’s not even downplayed as if these are tiny infractions either. “Regulatory significance” means the violation is, well, significant.
In other words, the great FDA watchdog is really one of those big, fat, sweet old dogs that, even if they wake up long enough to notice that there is a thief in the house, they would probably only lick his hand a couple of times before the criminal departs with your good silverware and Wii console.
Another interesting fact from the Inspector General’s report was that there had been previous Inspector General reports. These reports noted “... documented weaknesses in the oversight that FDA and IRBs provide for clinical trials,” “...that IRBs lacked the time and the expertise to sufficiently monitor the research taking place under their jurisdiction,” and that “...IRBs often conducted minimal review of studies after the initial approval of the research.”
These older reports were done almost ten years before the one that I have been quoting, yet little has changed. I guess we’ll just have to hold out hope that the 2019 Inspector General report might be the one that finally gets the job done.

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