Ethics sting in Big Pharma country

As an academic epidemiologist I routinely do NIH funded research involving human subjects. That means my university must adhere to very strict regulations and guidelines for the protection of research subjects. Approval and monitoring of the ethical conduct of research funded by the Department of Health and Human Services (DHHS), of which NIH is a part, was made a legal requirement in the 1970s following widespread abuses, of which the Tuskeegee Syphilis Study and the experiments by Nazi doctors were the most notorious. But less flagrant ethical breeches were widespread in medical research. I was in medical school when Harvard anesthesiologist Henry Beecher's New England Journal article (Beecher, H.K., Ethics and Clinical Research. New England Journal of Medicine. June 1966) on unethical medical research was published. It was like turning a switch in the medical community from almost total obliviousness to sudden realization.

A legal consequence was the National Research Act of 1974. Now DHHS funded research and any studies done for the Food and Drug Administration (FDA) submitted for drug or medical device approval must have a formal committee, called an Institutional Review Board (IRB), to review, pre-approve and monitor research plans and protocols. Obtaining IRB approval at most research universities can be an onerous and frustrating experience, but most researchers accept it as a reasonable cost for the privilege of pursuing our profession when it involves the lives and well-being of our patients or study subjects. Every aspect of our research plans are examined, including how subjects are recruited, whether any coercion is involved, either overt or subtle, what kind of informed consent language is used and whether risks are fully explained and worth the benefit. This means also examining questionnaires and the security and protection of any information that might potentially harm patients. The academic IRBs I have dealt with have been very tough, occasionally, exasperating, but that's the view of a researcher who wants to get on with science. We have a conflict of interest, so IRBs are a necessary thing. My university IRB reviews studies for the whole medical center, hundreds each year. Serving on an IRB is a significant time commitment.

What if you aren't a university researcher, for example, a drug company? The company also must have an "independent" IRB if it wants to use any scientific data it generates for gaining approval of a drug or medical device. If the study is done at an academic institution, whether funded by DHHS or not, it must also go through its IRB. But if not, the drug company can hire a company to do it, and over time a number of for-profit companies have sprung up for the express purpose of providing IRB services. Now if my IRB is giving me a difficult time (which happens on occasion), there's nothing I can do about it but work with them on the items that concern them. It's their decision that governs. I have no other IRB to go to. But if a company is hiring an IRB there is nothing to prevent them shopping for a light touch, ethically. When the Democrats assumed control of congress again in 1996 2006, they also started doing the kind of legislative oversight that the Republicans abandoned in 1994. One of the things the House Energy and Commerce Committee turned its attention to was whether the public was being adequately protected by for-profit IRBs. They ran a sting operation by hiring companies to review and monitor fake clinical trials with an equally fake surgical gel made by a fake company. One of the first companies to get caught, Coast IRB, has now announced it is going to close:

A Colorado company that approved a fake medical study in a congressional sting operation said it will close.

Coast IRB said the disclosure of the sting and an April 14 warning letter from the Food and Drug Administration describing the company's violations led several high-profile customers to pull their business. As a result, "Coast IRB's owners decided, through counsel, to cease future company operations," a company statement said.

The company had said earlier that it intended to temporarily halt accepting new business and to stop enrolling patients in studies that had begun while it made a thorough overhaul of its operations. (Alicia Mundy, Wall Street Journal; h/t PT)

Coast had many high profile biotech and pharmaceutical clients. The FDA said that as many as 3000 researchers and 300 clinical trials might be affected. Thus there is a serious logistical problem as these studies must be migrated to alternative IRB oversight. It's almost certain that Cost isn't the only bad actor.

Big Pharma always complains about onerous regulatory requirements, but those requirements usually come about in response to some egregious practice. Now approvals will be delayed further. This is the bitter fruit of the era of deregulation and lack of oversight that started with the Reagan administration. Conservatives love to hail the Reagan revolution (and indeed many of them got rich as a result), but for most of us in public health it was nothing but a wrecking ball for fundamental protections in health and safety, and ethics took its own independent hit.

But that's not news. Just read the newspaper.


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This sounds a lot like the practice of hiring "independent" arbiters to handle the mandatory binding arbitration you find in most consumer banking and credit card agreements.

Nothing overt, of course, you'd never actually tamper with a verdict; but I'm sure we'll know who to pick for the next case...

Unfortunately this doesn't address the practice of quacks (think DAN, Wakefield, Shoemaker, and the Geiers) creating their own foundations and IRBs to rubber-stamp highly unethical "studies."

For that matter, the IRB oversight at Columbia for the Gonzalez pancreatic cancer "study" and the national TACT "study" weren't all that rigorous either.

This isn't a problem confined to pharmaceutical companies.

By D. C. Sessions (not verified) on 24 Apr 2009 #permalink

"This isn't a problem confined to pharmaceutical companies."

Right. And it isn't even confined to "for profit" IRBs/REBs. It's symptomatic of an attitude that is widespread in the world of research -- namely, that "ethical oversight" is a pro forma activity, engaged in to satisfy the "criteria" promulgated by regulatory bodies. WRONG... Ethical oversight IS about protoecting the rights and welfare of research subjects.

By bob koepp (not verified) on 24 Apr 2009 #permalink

When the Democrats assumed control of congress again in 1996

Did you mean 2006, not 1996?

Big Pharma always complains about onerous regulatory requirements, but those requirements usually come about in response to some egregious practice.

And the cycle continues.

University fears of litigation also play an enormous part in making requirements significantly more burdensome and seemingly out of the scope of the IRB. Hence, pushback from pharma companies and those of us at universities end up losing good trials.

This is such a shame.

Also eye opening is when, at an Ivy medical school, an IRB proptocol for a plain vanilla education study --that does not collect data that could threat or harm a student-- is put through a two month rigorous review requiring detailed but meaningless changes to the protocol, while another ed protocol involving blood draws of our students for a variety of medical tests sails through in a couple of days -- because that prof had his pharm IRB specialist "run it through".

Oh, I see, and pray tell me: Where is this "run it through" fast track process for pharm IRB specialists written up in the IRB manual? Stop asking questions, I was told by a sub-dean.