Tuesday, July 20, 2010

Irregularities in Brain Research at Columbia University: A Breach of Trust

by Michael J. Fitzpatrick, Executive Director

Late last week, The New York Times and The Los Angeles Times broke the news that the prestigious Kreitchman PET Center at Columbia University suspended some current research studies because of “sloppy practices” by researchers. The study under scrutiny involves brain imaging research of people living with mental illness and safety violations that could endanger these individuals.

This disregard for participant welfare is alarming, to say the least. Research is one of the central components of NAMI’s advocacy platform. Research will lead to better treatments and better quality of life for people living with mental illness and, we believe, a cure. It is appalling that after all the advocacy it has taken to promote much-needed research, it could founder upon shoddy practices that threaten the lives of individuals and the future of scientific investigation.

The entire enterprise of research is built upon “the trust implicit between research participants and investigators”—participants know that the treatments or tests may or may not help them directly but the results may help someone like them. The study participants at Columbia’s Kreitchman PET Center—which performs brain research on conditions like schizophrenia and major depression—were acting with the greater good in mind, yet some of these participants were exposed to inappropriately prepared radioactive compounds.

These irregularities were then covered up by “systematic forgeries condoned and approved by the lab director.”

The revelations about ongoing improprieties at the Kreitchman Center scandal suggest that answers must be sought in support of a thorough resolution, among them:

Did the Kreitchman Center’s IRB carry out their responsibilities to protect the best interests of research participants and were its members fully informed of safety concerns raised by the Food and Drug Administration (FDA) in its 2008 review?

Are researchers who have a personal stake in the outcomes of their own research capable of objectively carrying out quality control responsibilities? Shouldn’t quality control be the responsibility of those outside the research enterprise?

In addition to our concern about the safety of the individual research participants, NAMI worries that any family touched by mental illness now or in the future—potentially any family—will pay the price for the corners cut by short-sighted researchers. Investigation into the biological basis of mental illness has had profound implications for people living with conditions. Flawed practices and lack of trust may set back research and prevent important breakthroughs in understanding the nature of serious mental illness and identifying treatments that can foster recovery. This would be tragic indeed.

It is time for the research community, including regulatory agencies and researchers themselves, to step forward and develop and adhere to procedures and safeguards that will protect the interests of participants while allowing important outcomes to proceed and flourish.


Al Araujo said...

Quality control, ethical adherence, and informed consent with associated risks, should be performed by groups not affiliated with the testing organization and should be funded by outside organizations.

JTowber said...

I was a Columbia research patient in 2007. the school had been delivering impure brain drugs since 2004. Six years of nonaction and continuation finally led to the FDA shitting the lab. Externally checking the research is insufficient. Only a moratorium on this research is sufficient. The clinical staff, research staff, IRB and the FDA allcould have done something. They did not. The research is inherently flawed and should cease to be. And I am not against pharmacological use or research. Hardly. but this is a calamity,unethical unjust and nonconsensual. Prior knowledge of the drug impurities was known, ignored,discovered and reignored. It takes a kind of arrogance and nonHippocracy to do that.

Elsie said...

Millions of people read and observed of what organizations has been tested. We should not just released the out-come without so much facts and proven evidence, for we know it will just create more problem.

Elsie said...

All has been said and done. Lesson to learned that hope in any organizations that has to be done and studied, let's just hope that it is well studied.

Cremation Jewelry said...

So sad to hear about what you shared JTowber..

Anonymous said...

NAMI is in bed with BigPharma.

In order to bring more drugs to market and make a profit, research needs to be conducted on vulnerable psych patients, some of whom don't understand the risks or feel unable to refuse. Many patients have died from this aggressive biological approach and the medications have not improved care that much.

We have lots of adequate drugs and exams now. Let's concentrating on improving the access to responsible care.

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