Clinical research in this country is a river of corruption that runs wide and deep and extends from coast to coast. What is a common thread? The ghost-written research publications. The fraudulent pharma-sponsored clinical research is quite often linked by the ghost-written publications. There’s an enormous paper trial of these publications on the internet, which at this point will be very difficult to hide. When multiple joint malfeasors show up on the same “research” publication, you must soon conclude that they are not isolated Black Swan Events. There’s a pattern to the serial related research frauds. Black swans do not appear in patterns. Clinical research fraud has not being aggressively prosecuted. Yes, some notorious cases have been fully prosecuted, but not many of them. Why not? Because to aggressively prosecute “high-enrollers”, who routinely conducted dozens of research studies simultaneously, for research fraud, would result in the need for FDA to retract the fraudulent clinical research upon which expedited market approvals of multiple new drugs were granted under the Prescription Drug User Fee Act (“PDUFA”).

An illustrative example is the Borison/Diamond research scandal in Augusta, GA for which Richard L. Borison, M.D. pled guilty to 36 criminal charges of theft, false statements and violation of the state’s Racketeer Influenced and Corrupt Organization Act. Dr. Borison was sentenced to 15 years in prison followed by 15 years’ probation, fined $125,000, ordered to pay $4.26 million in restitution, and debarred by the FDA. He was released in 2008 after serving about 10 years in prison.

There are many such examples. There have been some extremely egregious violations of the Nuremberg Code and Declaration of Helinski over the last 2 decades. It’s a veritable rogue’s gallery of moral terpitude. The public doesn’t have a clue as to the degree of corruption.

There are still many excellent and valuable med ed programs out there. But yes, the flavor, slant, and “influence” can reek at many med ed venues. Much of this will begin to change in the coming year per the new med ed guidelines.

There is another topic of concern that gets far less press. It is the influence of pharma money and the conduct of human clinical trials. Perhaps this should be Grassley’s next crusade(?).

The average person is clueless that their loved one’s “luck” in being accepted into a clinical trial for cancer treatment, etc. can also translate into money in someone’s white pockets. I’m talking about money that is above and beyond the nuts and bolts financially needed to cover the normal cost of overhead - support staff, supplies, etc.

Prime examples: the big buck bonuses (cash or even stocks)for securing IRB approval, for meeting enrollment deadlines, and for meeting enrollment numbers or exceeding them (so-called “over-enrollment”); the per-participant payments and “finders fees” ($$ paid out to the MD/facility for signing up each patient); pharma setting up structure so that the research sites actually *compete against each other* to meet a defined patient recruitment goal (those sites that fail to retain enough patients per timeframe may even be dropped form the clinical study, therefore losing their chance at the clinical trial bucks).

For details about such clinical trial hijinks, see page 11 and the rest of the recent Nov. 2009 white paper entitled “Conflicts of Interest in Clinical Trial Recruitment and Enrollment: A Call for Increased Oversight. Page 11 is especially noteworthy. The pdf is accessible at the link:

http://law.shu.edu/ProgramsCenters/HealthTechIP/upload/health_center_whitepaper_nov2009.pdf

I hope he publishes the pay and compensation packages the CEOs and other top dogs in these “charity” groups take home too.

The ones I was able to dig up in IRS filings were outrageous!