Background:
Medical research is fast becoming a disreputable business: a haven for promoters who think nothing of committing fraud, scientific misconduct, forging signatures (when expedient) or doing whatever speeds up the process for gaining an FDA marketing license.
If you think that doctors conducting medical research are necessarily qualified to conduct them, or that they are in good standing with state medical boards, you’d be surprised to learn there are no special licenses nor mandatory requirements for special training, nor is there a routine background check on physicians doing clinical research. The system relies on ethics review boards–institutional review boards (IRBs) at academic medical centers, or commercial CROs hired by corporate sponsors. In both cases–IRBs and CROs–are dependent on those that employ or hire them.
A Congressional sting operation demonstrates that the current system whose purpose is to protect the integrity of science and the safety of human subjects–is a mirage.
The New York Times and The Wall Street Journal reported earlier this month about a Congressional sting operation carried out by the Government Accountability Office that found it mighty easy to gain approval from an ethics review boards to conduct medical experiments on human beings.
In fact, even a fictitious company with a fictitious address, and a fictitious medical product, headed by a businessman with fraudulent credentials can hire a "licensed" independent research review board to lend the illusion of legitimacy dubious medical experiments conducted on human subjects.
Five months after Coast Independent Review Board (a commercial CRO) gave the fictitious company, Device Med-Systems, approval to begin testing the fictitious adhesive, its clinical trial. Prompting that credential check was a letter from Mr. Stupak’s panel inviting Mr. Dueber to Washington to testify about the study.
The sting operation was at the behest of the House Sub-Committee on Investigations and Oversight.
Further adding to the discomfort level: the FDA did nothing to protect the safety of patients, allowing Coast IRB to continue operating despite serious concerns, taking action only after the Times and Journal disclosed some of the facts.
The Wall Street Journal reports (below) that another research scam uncovered by the GAO sting involved a "bogus IRB with a pet dog as its CEO."
Another FDA warning letter addressed to Dr. Charles Cote, involves Harvard Medical School affiliate, Massachusetts General Hospital.
The letter indicates that informed consent documents contained forged signatures for the legal guardians of three children who were enrolled in a trial testing Schering-Plou’s anesthesia drug, Zemuron. Signatures were obtained post-hoc, at least two of the children’s guardians didn’t speak English but the consents they signed were in English…the list of violations goes on and on… Indeed, the FDA letter states:
"This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address these deficiencies and establish procedures to ensure that any on-going or future studies will be in compliance with FDA regulations.
If you can’t trust that medical research conducted at Harvard University affiliated hospitals would be in compliance with MINIMAL federal regulations, who can you trust?
FDA failed to excercise its authority until a month after the violations were reported by the NY Times and the WSJ.
Perhaps the GAO, rather than the FDA should be entrusted with oversight over medical research–the GAO staff do a far better job than either FDA or academic institutions at preventing unethical human experiments, or feretting out bogus tests from genuine research.
posted by Vera Hassner Sharav
THE NEW YORK TIMES
March 13, 2009
Testing Firm Finds Itself Being Tested
By BARRY MEIER
Like other federal undercover operations, this one had the usual trappings, like a company whose address turned out to be a P.O. box in a strip shopping mall and a businessman whose credentials proved fraudulent.
But the investigation had an unusual focus: determining whether companies that are paid to oversee the safety of patients in clinical studies of drugs and medical devices do their job. The inquiry came to light this week when one of its targets, a Colorado company, exposed it – via news release.
The company, Coast Independent Review Board, said it had been duped by federal officials last year when it agreed to oversee a study of Adhesiabloc, a product designed to reduce scar tissue after surgery.
As it turns out, there is no such product. Its developer, Device Med-Systems, does not exist. And neither, apparently, does Dr. Jonathan Q.
Kruger, the Virginia doctor with a four-page curriculum vitae who was supposedly leading the research."The fraudulent trial was apparently commenced as part of a Congressional ‘sting’ operation," Coast, which is based in Colorado Springs, said in its release.
The company’s president, Daniel Dueber, said he believed the operation was an unwarranted effort by the House Energy and Commerce Committee’s Subcommittee on Investigations and Oversight to embarrass firms like his.
The subcommittee, whose chairman is Bart Stupak, Democrat of Michigan, has been investigating companies and others that monitor the safety of patients in medical studies.Critics contend that too many of the companies in that business may be slipshod in monitoring trials because they do not want to alienate the companies that pay them, a contention that officials like Mr. Dueber rejects.
"They want to come out of this grandstanding" he said, referring to the House subcommittee.
Nick Choate, a spokesman for Mr. Stupak, declined to comment on the inquiry.
But he said that Coast would be part of a hearing later this month, and "all the facts related to this investigation will be discussed at that time."The undercover investigation of the trial industry was conducted by the Government Accountability Office, a research arm of Congress, at the subcommittee’s request, a G.A.O. spokesman said.
Medical experts say that companies that oversee clinical trials need, at the very least, to be familiar with the sponsors of the trials and to ensure that the doctors are qualified to conduct them and are in good standing with state medical boards.
As for Coast, its due diligence seems to have started late.
In a telephone interview, Mr. Dueber said his firm began investigating the bona fides of the Adhesiabloc study last week – five months after it gave Device Med-Systems approval to begin its clinical trial. Prompting that credential check was a letter from Mr. Stupak’s panel inviting Mr. Dueber to Washington to testify about the study.
In the days since, Mr. Dueber said the company discovered that the address given for Device Med-Systems, the site where the study was supposed to be conducted, was a store that rents mail boxes in a strip mall in Clifton, Va.
He also learned that the Virginia medical licenses of the physicians involved in the study were fake, including the one for the principal investigator, Dr. Kruger. (There is an ophthalmologist named Dr. Jonathan P.
Kruger who is licensed in Virginia; he could not be reached for comment on
Thursday.)Asked why Coast had not undertaken those background checks when it agreed last October to monitor the study, Mr. Dueber said it never occurred to him that anyone would develop a study that was not real.
He added that the only issue raised in October by Coast’s medical board, which includes several real doctors, was a request for revisions in the study’s patient consent form. A Coast official, he said, had spoken by phone with the supposed head of Device Med-Systems, who identified himself as Paul Jennings and agreed to make the requested changes. "It was very congenial,"
Mr. Dueber said.He said that Coast had followed all federal rules in approving the Adhesiabloc study, but that the company had now revised its own policies.
As for the undercover investigation, signs of it were still visible on Thursday. The Web site for Device Med-Systems was still operating, as was a telephone number for the company.
Calls placed to Dr. Jonathan Q. Kruger and Paul Jennings at the number listed for Device Med-Systems were not returned.
Copyright 2009 The New York Times Company
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THE WALL STREET JOURNAL
Was a Three-Legged Dog Head of a Review Board?
March 26, 2009A congressional committee’s sting operation into medical research — one that included setting up a fake company with a fake surgical adhesive to be used in a fake clinical trial — will be detailed this morning in a hearing scheduled in the House Energy and Commerce Committee on the need for more oversight by – and of – institutional review boards.
IRBs are empowered by regulators to decide whether planned clinical research involving humans should be allowed to go ahead, but how good a job board members do has been under the spotlight. The committee, headed by Rep. Henry A. Waxman, will focus on the issue at today’s hearing run by Rep. Bart Stupak.
The tale of the surgical adhesive has already been aired in a news release by the IRB in question – Coast IRB of Colorado – which OKed the clinical trial five months before learning that the company, Device Med-Systems, and its wonder product, Adhesiablog, didn’t exist. Both were created as part of the House committee’s sting.
But another tidbit expected to surface today is the panel’s plan to also set up a "bogus IRB with a pet dog as its CEO," according to a congressional memo seen by Health Blog.
The invented IRB’s CEO was to have been named "Trooper," after a Capitol Hill staffer’s beloved three-legged dog, Health Blog was told.
The canine (not pictured above) is said to have hung out on occasion with the attack dogs of then-Chairman John Dingell’s investigative team, and apparently liked to sniff around almost as much they do.
No one would confirm whether the fake IRB or its bogus CEO were ever launched.
Hearing update: Rep. Greg Walden, R-Ore., criticized Health and Human Services officials for failing to catch the fictitious IRB and registering it despite numerous red flags. "Nobody picked up on names like Phake Medical Devices, April Phuls, Timothy Witless and Alan Ruse – in the town of Chetesville, Ariz.?" he asked department reps.
Bonus update: Rep. Stupak, in his opening statement, reported that Trooper, alas, had died, but for a three-legged dog, he sure could catch a Frisbee.
Photo by Jeb Ro via Flickr
Copyright 2008 Dow Jones & Company, Inc. All Rights Reserved
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THE WALL STREET JOURNAL
Sting Operation Exposes Gaps in Oversight of Human Experiments
By ALICIA MUNDYWASHINGTON — Thousands of medical research groups that monitor clinical trials on behalf of the drug industry may face tougher regulations in the wake of a congressional sting operation that found gaps in the nation’s oversight of experiments on humans.
The sting, detailed at a House Energy and Commerce Committee hearing Thursday, involved the creation of a fictitious company and a fake medical device, a surgical adhesive gel. The sham firm then applied to three for-profit oversight groups — called institutional review boards, or IRBs — for approval to begin a clinical trial using their adhesive on human subjects.
Drug and device makers along with hospitals and university research facilities must retain an independent IRB to oversee the methodology and safety issues for human studies. Corporations cannot get Food and Drug Administration approval for their products without an IRB certifying their clinical trials. About 6,350 IRBs are registered with the Department of Health and Human Services.
Lawmakers have raised concerns over whether IRBs routinely approve medical studies for paying clients. The committee leaders are considering whether to introduce a bill to strengthen IRB regulations.
Two IRBs contacted by the GAO’s sting operators — Argus IRB of Arizona and Fox IRB of Illinois — rejected the Adhesiabloc proposal because of unanswered safety questions.
"We realized it was a terrible risk for the patient … It is the worst thing I have ever seen," an Argus IRB reviewer said, according to a slide shown at the hearing.
Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, "Adhesiabloc." Five months after approving the study for abdominal surgery patients, Coast learned that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed.
Coast CEO Dan Dueber said in an interview that the congressional case was illegal entrapment. At the hearing, Mr. Dueber testified, "The GAO perpetrated an extensive fraud against my company. You pulled the wool over our eyes — congratulations." Because the product was fake, it was never used.
As part of the sting, the committee also created a sham IRB to see whether the Department of Health and Human Services, which registers IRBs, would certify their fictitious group.
The committee, working with the Government Accountability Office, Congress’s investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer’s three-legged dog, now deceased. Other fake names included "April Phuls" and "Timothy Wittless," which lawmakers said should have signaled irregularities to HHS. The department registered the IRB.
At Thursday’s hearing, the toughest complaints were reserved for HHS. Rep. Joe Barton of Texas, the committee’s ranking Republican, asked one HHS official: "Do you have any sense of outrage?" Referring to Coast, he continued, "What steps are being taken right now to decertify these charlatans?"
The director of HHS’s office that registers review boards, Jerry Menikoff, said at the hearing that his bureau had only recently received the committee information about Coast, and would look into the matter.
Write to Alicia Mundy at alicia.mundy@wsj.com
Copyright 2008 Dow Jones & Company, Inc. All Rights Reserved