In a little-noticed article over at The New York Times late last week, Benedict Carey noted how one of Columbia University’s premier research centers — the Kreitchman PET Center — had to halt all of its research studies because researchers were caught cutting corners. Not just once, but over and over again.
We’re not talking about flubbing up statistical data here. We’re talking about creating and administering improper, impure drugs to research participants. Drugs that may not only harm patients, but could even impact the researcher’s findings. (And researchers then wonder why it’s so hard to get research subjects…)
What is the Kreitchman PET Center? It is (or was) the nation’s leading research organization using positron emission tomography (PET) for psychiatric research. This is the cream of the crop when it comes to using PET scans in an effort to unlock the secrets of the brain to better understand it.
Worse yet, it wasn’t just a matter of researchers having lax quality control and not correcting it because they didn’t know about it — they knew about it and continued administering drugs in an unethical and unsafe manner to patients. Then they worked to cover up their behavior.
“Failure to promptly correct these violations may result in legal action without further notice,” the agency wrote to Columbia in December 2008, citing lax internal quality control and sloppy procedures for formulating drug injections.
F.D.A. investigators returned in January 2010 and found that many of the center’s lab’s practices had not changed, and cited a long list of specific violations, including one instance in which the staff hid impurities from auditors by falsifying documents.
In order for a PET scan to work, doctors inject a low-level radioactive drug into a person’s bloodstream. Because the radioactivity is so low and degrades very quickly, the drug must be manufactured on-site — right in the researchers’ own labs. Not surprisingly, research facilities are not the best people to put in charge of manufacturing drugs, because drug manufacturing is a very risky and error-prone process. Entire batches of drugs in pharmaceutical plants are regularly discarded because they fail quality assurance checks. But pharmaceutical companies — since they’re in the business of manufacturing drugs — know about this and account for it in everything they do.
Research labs, on the other hand, aren’t in the business to manufacture drugs. So they don’t care about quality control as much, and often can’t afford to throw away a whole batch of drugs just because they don’t pass quality testing. That’s what apparently was happening at Columbia University’s Kreitchman Center. Researchers under pressure to get their studies done cut corners when it came to ensuring drug quality control.
But here’s the real kicker — these low-level radioactive drugs can also directly impact mood and behavior.
Radiotracers that target receptors in the brain, as used in many of the Columbia studies, are more prone than other PET drugs to be biologically active — to affect mood or behavior, especially in those who already suffer from severe depression or other mental problems.
“You have to have additional quality-assurance procedures if you’re using agents that bind receptors in brain,” said Dr. Dennis P. Swanson, chairman of the radiation safety commission at the University of Pittsburgh.
Instead of having additional quality-assurance procedures, these yahoos over at the Kreitchman Center were apparently just using anything that had available — regardless of its impact on their subjects or research. While no known harm came to research subjects because of the use of these drugs, it’s not known (nor is it likely able to be known) how the use of these impure drugs may have affected all of the research conducted in this lab during this time. It may have altered the mood and behavior of subjects under research, resulting in researchers drawing faulty conclusions in their peer-reviewed, already-published studies.
The researchers responsible should be immediately fired from their positions at the center, and a full criminal investigation should be opened. Apparently, those management overseeing the lab were well aware of the shortcuts the researchers were taking and encouraged them, in order to save time and keep their lucrative research grants coming.
Former employees, speaking on the condition of anonymity because they worked in the imaging field or hoped to, said those practices were not only commonplace but also condoned. They described a center under such pressure to produce studies that it papered over and hid impurities in drugs to stretch its resources and went ahead with business as usual despite F.D.A. warnings.
“These are not the actions of a rogue, but instead are systematic forgeries condoned and approved by the lab director,” wrote one employee in a 2009 resignation letter addressed to Dr. Ronald L. Van Heertum, the PET center’s co-director at the time.
So what is Columbia University doing? Is it firing the former directors? Nope, it appears it is just reshuffling the management in a typical whitewashing done after an organization is caught doing things it not only shouldn’t be doing, but knows it shouldn’t be doing:
“We acknowledge serious shortcomings of quality control in the manufacturing process and record-keeping at this lab,” said David I. Hirsh, Columbia’s executive vice president for research. “That is why we are fundamentally reorganizing the lab’s management and operations in response to what the F.D.A. told us.”
The days of treating research subjects — especially those with a mental illness — like guinea pigs with impunity and a complete disregard for safety and ethics ended (I thought) in the 1960s.
Incidents like this clearly demonstrate (again!) what happens when you don’t have checks and balances in place — even on researchers and prestigious research institutes. It also demonstrates how little interest universities have in oversight of their own research institutes and faculty (unless and until, of course, they are caught red-handed).
It also demonstrates how the American College of Radiology accreditation that the Kreitchman Center held was apparently worthless. An accrediting body is next to useless, in my opinion, if it can’t catch its own members in acts of unethical behavior and fraud.
Kudos to the U.S. Food and Drug Administration for not only the initial investigation, but the followup investigation as well. And to The New York Times for reporting on it.
Read the full article: Brain Center at Columbia Gave Patients Impure Drugs
Columbia Kreitchman PET Center (Internet Archive link; Columbia has removed the website from its active servers for unknown reasons)